EnglishAll4 1.2.3.4-2009-Versao-Corrigida-2010 PT - BR en HFS

Freely available Standard through an ABNT-ABIQUIM Agreement
BRAZILIAN STANDARD
ABNT NBR 14725-1

First Edition 08.26.2009 Valid from: 09.26.2009 Corrected copy 01.26.2010
Chemicals Information about safety, health and environment Part 1: Terminology

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)
ICS 71.100.01 BRAZILIAN ASSOCIATION OF TECHNICAL STANDARDS
ISBN 978-85-07-01703-5 Reference number ABNT NBR 14725-1:2009 9 pages ABNT 2009
ABNT NBR 14725-1:2009
ABNT 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any
means, electronic or mechanical, including photocopying and microfilm, without prior written permission from ABNT.
ABNT Av.Treze de Maio, 13 - 28 andar 20031-901 - Rio de Janeiro RJ Tel.: + 55 21 3974-2300 Fax: + 55 21 3974-2346 abnt@abnt.org.br www.abnt.org.br
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ABNT 2009 All rights reserved.
ABNT NBR 14725-1:2009
Contents
Foreword v
Page
Introduction................................................................................................................................................................vi 1 Scope 1 2 Terms and Definitions..............................................................................................................................................1 Bibliography................................................................................................................................................................9 Foreword 15 Introduction...............................................................................................................................................................16 1 Scope 1 2 Normative references..............................................................................................................................................1 3 Terms and definitions..............................................................................................................................................1 4 Criteria for hazard classification of a chemical product - Mixtures and substances.................................................1 5 Hazard classification to the human health...............................................................................................................4 6 Hazardous to the aquatic environment .................................................................................................................61 7 Physical hazards....................................................................................................................................................73
Anexo A (informativo) Mtodos de ensaios..............................................................................................................96 Bibliography..............................................................................................................................................................98 Foreword 5 Introduction.................................................................................................................................................................6 1 Scope 1 2 Normative references..............................................................................................................................................1 3 Terms and definitions..............................................................................................................................................1 4 General considerations............................................................................................................................................1 5 Safety information for the labeling hazardous chemicals.........................................................................................2 6 Product label specifications.....................................................................................................................................2 Anexo A (informativo) Correlao entre as informaes da FISPQ e da rotulagem de produto qumico perigoso.....4 Anexo B (normativo) Instrues para incluso das informaes de segurana no rtulo do produto qumico perigoso 5 B.1 Product identification and supplier emergency telephone....................................................................................5 B.2 Chemical composition..........................................................................................................................................5 B.3 Hazard pictograms...............................................................................................................................................5 B.4 Signal words.........................................................................................................................................................6 B.5 Hazard statement.................................................................................................................................................6
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ABNT NBR 14725-1:2009

B.6 Precautionary statements.....................................................................................................................................6 B.7 Other information..................................................................................................................................................6 Anexo C (normativo) Smbolos de perigo...................................................................................................................7 Anexo D (normativo) Pictogramas de perigo, palavras de advertncia e frases de perigo.........................................8 Anexo E (informativo) Frases de precauo.............................................................................................................20 Anexo F (informativo) Exemplos ilustrativos de rtulos............................................................................................28 F.1 Combination packaging for a Category 2 flammable liquid.................................................................................28 F.2 Inner packaging: Category 2 flammable liquid and Category 2 skin irritant ......................................................30 F.3 Overwrapping with two combined packages: one with flammable liquid Category 2 and another containing a skin irritant Category 2..............................................................................................................................................31 F.4 Product label......................................................................................................................................................32 Bibliography..............................................................................................................................................................35 Foreword 5 Introduction.................................................................................................................................................................6 1 Scope 1 2 Normative references..............................................................................................................................................1 3 Terms and definitions..............................................................................................................................................1 4 General considerations............................................................................................................................................1
5 Content and general model of a FDS......................................................................................................................2 Anexo A (normativo) Instrues para a elaborao de uma FISPQ...........................................................................4 Bibliography..............................................................................................................................................................20
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ABNT NBR 14725-1:2009
Foreword
The Brazilian Association of Technical Standards ABNT (Associao Brasileira de Normas Tcnicas) is the National Forum of Standardization. The Brazilian Standards, whose content is under the responsibility of the Brazilian Committees (ABNT/CB), Sectorial Standardization Organisms (ABNT/ONS) and Special Study Committees (ABNT/CEE), are worked out by Study Committees (CE) composed of representatives from the involved sectors, such as: Producers, consumers and neutral entities (universities, laboratories and others). The ABNT technical documentation is made according to the rules set forth in the ABNT Guidelines, Part 2. The Brazilian Association of Technical Standards (ABNT) emphasizes that some elements of this document may have patent protection. ABNT should not be held responsible to point out any patent rights. The Standard ABNT NBR 14725-1 has been worked out within the Brazilian Committee of Chemistry (ABNT/CB10) by members of the Committee for Information Studies on Safety, Health and Environment related to Chemicals (CE-10:101.05). Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-004, whereas the 2nd. Project was also sent to Nationwide Query through the Invitation to Bid no 09, carried out from 09/02/2008 until 10.01.2008 named 2nd for Project 10:101.05-004. The ABNT NBR 14725 standard entitled Chemical Products - Information on Safety, Health and Environment ("Produtos qumicos - Informaes sobre segurana, sade e meio ambiente") is expected to approach the following: Part 1: Terminology; Part 2: Hazard Rating System; Part 3: Labeling; Part 4: Material Safety Data Sheet (MSDS).
This ABNT NBR 14725-1 first edition, jointly with Parts 2, 3 and 4, supersedes and cancel the ABNT NBR 14725:2005 print, which has been technically revised and dismembered in parts. This ABNT NBR 14725-1:2009 corrected print includes Errata 1 dated 01/26/2010.
ABNT NBR 14725-1:2009
Introduction
This ABNT NBR 14725 part was meant to set forth the terms used in ABNT NBR 14725-2, ABNT NBR 14725-3 and ABNT NBR 14725-4. ABNT NBR 14725 is part of the effort to implement the Globally Harmonized System (GHS) of information security on hazardous chemicals. Decree 2657 of July, 3rd, 1998, which issued the Convention No.170 of the International Labor Organization (ILO), establishes some responsibilities for the implementation of the ABNT NBR 14725 standard. ABNT NBR 14725 was based on the following GHS basic assumptions: The need to provide information on hazardous chemicals related to safety, health and environment issues; The right of the target public become familiar and able to identify the dangerous chemicals commonly used and their associated risks; The utilization of a simple identification system, which could be easily understood and applied in the different sites where dangerous chemicals are used; The need to make this consistent system compatible with the classification criteria for all anticipated hazards by GHS; The need to facilitate international agreements and to protect industrial secrets and confidential information; The workers' training and skill building, and The development of consumers' education and awareness.
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ABNT NBR 14725-1:2009
vii
BRAZILIAN STANDARD
ABNT NBR 14725-1:2009
1 Scope
This ABNT NBR 14725 part defines the terms used in the chemical products Hazard Rating System, in the labeling of hazardous chemicals, and in Material Safety Data Sheets (MSDS).
2 Terms and Definitions

The following terms and definitions are relevant for this part of ABNT NBR 14725. 2.1 aerosol container made of metal, glass or plastic, non-reusable, containing a liquefied or dissolved compressed gas with or without liquid in paste or powder form, and fitted with a discharge device to expel its contents in a gas suspended solid or liquid particle mixture as foam, paste or powder, or in liquid or gaseous state.
2.2 explosive article article with one or more substances or explosive mixtures 2.3 aspiration admission of liquid or solid chemical directly through oral or nasal routes, or indirectly by vomiting, through the trachea or lower respiratory tract 2.4 bioaccumulation organism absorption, transformation and elimination output of substance through all exposure routes, such as, air, water, sediment / soil and food 2.5 bioconcentration organism absorption, transformation and elimination output of substance after being exposed to water 2.6 bioavailability indicates the extent to which a substance is absorbed and distributed to an area of such organism NOTE The bioavailability depends on the physical-chemical properties of the substance, on the anatomy and physiology of the organism, on pharmacokinetics and on the exposure route 2.7 carcinogenicity development of malignancies, e.g., the process of forming a malignant tumor (cancer) in an organism, as a resulting effect of the action of a carcinogen
ABNT NBR 14725-1:2009

2.8 carcinogenic toxic chemical substance, inert solid body or ionizing radiation able to induce carcinogenicity 2.9 danger category subdivision of a danger class EXAMPLE The 'oral acute toxic' class has four danger categories.
2.10 EC50 effective concentration of substance causing 50% of maximum response 2.11 ECr50 effective concentration in terms of reducing the growth rate 2.12 LC50 concentration of chemical in air or water that kills 50% of a group of animals undergoing assays 2.13 danger class kind of physical danger either to health or to the environment EXAMPLE Carcinogenic, flammable, acute oral toxicity 2.14 exposure control preventative measures for human protection against the effects of chemical exposure 2.15 cutaneous corrosive, skin corrosive test material capable to produce the destruction of skin tissue, called visible necrosis through the epidermis into the dermis, in at least one of three tested animals after 4-h exposure 2.16 corrosive to metals substance or mixture that can damage or even destroy metals through its chemical action 2.17 damage physical lesion and/or injury to the health, environment or property 2.18 degradability ability of a substance or mixture to degrade itself in the environment through the biodegradation process or other processes 2.19 degradation decomposition of organic molecules in smaller molecules, and finally, in carbon dioxide, water and salts. 2.20 additive effect effect quantitatively equal to the sum of the individual effects produced by two or more toxic agents
ABNT NBR 14725-1:2009

2.21 potentiation effect effect that happens when a toxic agent, acting simultaneously with non-toxic agent, has its effect increased. 2.22 synergic effect effect quantitatively greater than the sum of the individual effects produced from two or more toxic agents NOTE The synergic effect is greater than the additive effect
2.23 external packaging packaging intended to pack inner packings 2.24 inner packing packing containing the product directly and contained within an outer packaging 2.25 final packaging package intended to sell the product 2.26 simple package packaging consisting of one single container box which does not require an outer packaging to be transported 2.27 specialist person who has the knowledge, ability or special practice in a certain subject
2.28 personal protection equipment PPE any single-user device or product the worker uses for protection against health and safety threatening risks at work 2.29 mass explosion practically instantaneous explosion of almost the entire mass quantity 2.30 unstable explosives thermally unstable and / or highly sensitive explosives to be handled, transported and for the normal use 2.31 supplier responsible party to make a hazardous chemical available to the target public 2.32 flammable gas gas which becomes flammable in air at 20o C and at a reference pressure of 101.3 kPa 2.33 oxidant gas gas causing or contributing more than air for the combustion of another material, generally because it provides oxygen
ABNT NBR 14725-1:2009

2.34 gas under pressure gas contained in recipient either under no less than 280 kPa at 20 C or as a refrigerated liquid 2.35 biological indicator of exposure chemical parameter used to identify an occupational exposure which may be hazardous to health 2.36 in vitro everything produced or occurred in a laboratory environment outside the organism NOTA In vitro production or execution may be accomplished, for instance, either in a culture medium or into a test tube. 2.37 in vivo whatever is produced or done with a living organism 2.38 confidential information every information that potentially may jeopardize a supplier activity if disclosed to his/her competitor 2.39 component ingredient of a chemical product or pertaining to a residue 2.40 skin irritation growth of a reversible skin lesion as a consequence of the application of a product during a 4-hr long test
2.41 ocular irritation ocular lesions brought about as a consequence of some product applied into the anterior eye surface, which can be totally reversible within the following 21 days after the application 2.42 irritant product capable to provoke eye or cutaneous irritation 2.43 Kow partition coefficient n-octanol/water 2.44 serious eye lesion damage to the eye tissue or serious vision impairment as a consequence of some product applied into the anterior eye surface which does not show to be totally reversible within the 21 days following its application 2.45 concentration limit cutoff value reference value which sets forth the category of danger of a particular product
ABNT NBR 14725-1:2009

2.46 occupational exposure limit concentration of an agent, or maximum/minimum intensity of such agent, related to the nature and exposure period to the said agent, which will cause no harm to the worker throughout his/her working life. It has the same meaning of "tolerance limit". 2.47 mixture product consisting of two or more substances that not react together 2.48 mobility into the soil ability of a substance or mixture to reach the water table if released into the environment or to be carried over towards other places through natural environmental conditions 2.49 mutation permanent alteration in the quantity or in the structure of a cell genetic material 2.50 mutagenicity assessing the ability of chemicals to induce genetic changes in the nuclei of cells that are transmitted during cell division 2.51 mutagenic agent that increases the frequency of mutation in cellular tissues, or in organisms, or in both 2.52 commercial name name that identifies a product without having to associate it with its chemical name 2.53 chemical name scientific name name describing the atomic or molecular structure of a substance and being the official name followed by the structural and terminology rules of the International Union of Pure and Applied Chemistry, (IUPAC) EXAMPLE Dimetilbenzene.
2.54 technical name free name for general-purpose use to identify a chemical substance which does not require the use of its chemical name EXAMPLE Xilol, xylene
2.55 signal word word used in labeling a hazardous chemical intended to point out the relative level of danger severity and/or to warn the target public about a potential danger of that chemical 2.56 danger potential injury source and intrinsic characteristic of a product 2.57 persistence ability of a substance or mixture to remain detectable over time and not self-degrade through biodegradation or other processes in the environment
ABNT NBR 14725-1:2009

2.58 pertinent important information related to the security, health, environment, and/or uses related to chemicalss 2.59 pictogram graphical composition intended to transmit a particular information concerning danger or safety situations NOTE Every danger pictogram includes a symbol inserted in a square supported by one of its vertices. The safety pictogram does not have an established pattern. 2.60 hazardous chemical a chemical which is classified as hazardous to the safety, health and/or environment according to the classification criteria adopted. 2.61 chemical product substance or mixture 2.62 program for safety, health and environment set of actions aimed at to minimize risks in the workplace improving the safety and protection of health and environment 2.63 target public workers, consumers and professionals of emergency services and transport services
2.64 chemical residue substance, mixture or material leftover from industrial activities, health, agricultural or commercial services to be disposed of according to the environment regulations in force, such as those ruling the use in another process, or in reprocessing / recovery, recycling, co-processing, thermal destruction and landfill operations 2.65 risk probability of dangerous situations capable to cause damages 2.66 labeling identification through printing, lithography, painting, fire engraving, pressure, trace engraving or printed legend NOTE package Labeling can be applied in any unitary package of chemicals or on any other kind of protective
2.67 safety absence of unacceptable damage risks 2.68 skin sensitizer substance that will induce an allergic response following skin contact 2.69 respiratory sensitizer substance that induces hypersensitivity of the upper airways following inhalation of the substance
ABNT NBR 14725-1:2009

2.70 symbol graphical element with conventional meaning used to express graphically through a quickly and easily identifiable way a danger alert, warning, recommendation or instruction 2.71 globally harmonized system GHS set of rules, among other rules, for classification and labeling of chemicals aiming at the establishment of a common and consistent basis for classification and communication of dangers related to dangerous chemicals 2.72 overwrapping a way to group simple or external packages of compatible hazardous chemicals to facilitate their handling and transport 2.73 flammable solid solid substance easily combustible or that may cause or feed the fire through friction 2.74 substance chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the production process used, but excluding any solvent that might be separated without affecting the stability of the substance or change its composition 2.75 emergency telephone communication mean able to provide information concerning measures of safety, health and environment related to chemical products should an emergency occur 2.76 make FISPQ (MSDS) documents available make the FISPQ available in electronic format and / or in a physical location suitable to the user, such as a web site and / or sectors of customer services and / or phone / fax and / or other means 2.77 acute toxicity adverse effects after single or multiple doses of a substance by oral or dermal route at 24-h intervals, or resulting of one inhalation exposure period to such substance during a 4-h period 2.78 acute aquatic toxicity property of a substance to cause adverse effects to an aquatic organism after a short period of exposure 2.79 chronic aquatic toxicity property of a substance to cause adverse effects to an aquatic organism during predetermined exposures related to the life cycle of the organism 2.80 toxicity to reproduction well-known substance able to produce adverse effects on the sexual function or in the fertility of adult male and female species, and also in the development of their offspring
ABNT NBR 14725-1:2009

2.81 undue use use of a product or process under conditions or for purposes not specified by the supplier, albeit occurring induced by the appearance and characteristics of the product, combined with or resulting from predictable human behavior 2.82 user recipient party who receives a chemical product from a supplier for industrial or professional purposes such as storage, handling, processing, packaging, or distribution
ABNT NBR 14725-1:2009
Bibliography
[1] [2] [3] [4] [5] Decree 2657, of 03 of July of 1998, which publishes the Convention No 170 of the International Labour Organization (ILO). GHS book, Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Purple Book. NR 6 (Norma Regulamentadora, or Regulatory Standard), Equipamento de Proteo Individual EPI (Personal Protection Equipment PPE) NR 7 (Norma Regulamentadora, or Regulatory Standard) Programas de Controle Mdico de Sade Ocupacional PCMSO (Medical Control of Occupational Health Program) NR 15 (Norma Regulamentadora, or Regulatory Standard), Atividades e Operaes Insalubres (Unhealthy Activities and Operations)
BRAZILIAN STANDARD
ABNT NBR 14725-2

First Edition 08.26.2009 Valid from 09.26.2009
Chemicals Information about safety, health and environment Part 2: Hazard Classification System
Chemicals Information about safety, health and environment Part 2: hazard classification system
ABNT NBR 14725-2:2009
ABNT 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written permission from ABNT. ABNT Av.Treze de Maio, 13 - 28 andar 20031-901 - Rio de Janeiro RJ Tel.: + 55 21 3974-2300 Fax: + 55 21 3974-2346 abnt@abnt.org.br www.abnt.org.br
ABNT 2009 All rights reserved
ABNT NBR 14725-2:2009
Contents
Page Foreword v Introduction................................................................................................................................................................vi 1 Scope 1 2 Terms and Definitions..............................................................................................................................................1 2.1........................................................................................................................................................................1 aerosol.................................................................................................................................................................1 2.2........................................................................................................................................................................1 explosive article...................................................................................................................................................1 2.3........................................................................................................................................................................1 aspiration.............................................................................................................................................................1 2.4........................................................................................................................................................................1 bioaccumulation...................................................................................................................................................1 2.5........................................................................................................................................................................1
bioconcentration..................................................................................................................................................1 2.6........................................................................................................................................................................1 bioavailability.......................................................................................................................................................1 2.7........................................................................................................................................................................1 carcinogenicity.....................................................................................................................................................1 2.8........................................................................................................................................................................2 carcinogenic.........................................................................................................................................................2 2.9........................................................................................................................................................................2 danger category...................................................................................................................................................2 2.10......................................................................................................................................................................2 EC50....................................................................................................................................................................2 2.11......................................................................................................................................................................2 ECr50..................................................................................................................................................................2 2.12......................................................................................................................................................................2 LC50....................................................................................................................................................................2 2.13......................................................................................................................................................................2 danger class........................................................................................................................................................2 2.14......................................................................................................................................................................2
ABNT NBR 14725-2:2009

exposure control..................................................................................................................................................2 2.15......................................................................................................................................................................2 cutaneous corrosive, skin corrosive.....................................................................................................................2 2.16......................................................................................................................................................................2 corrosive to metals...............................................................................................................................................2 2.17 damage........................................................................................................................................................2 2.18......................................................................................................................................................................2 degradability........................................................................................................................................................2 2.19......................................................................................................................................................................2 degradation..........................................................................................................................................................2 2.20......................................................................................................................................................................2 additive effect.......................................................................................................................................................2 2.21......................................................................................................................................................................3 potentiation effect................................................................................................................................................3 2.22......................................................................................................................................................................3 synergic effect......................................................................................................................................................3 2.23......................................................................................................................................................................3 external packaging...............................................................................................................................................3
2.24......................................................................................................................................................................3 inner packing.......................................................................................................................................................3 2.25......................................................................................................................................................................3 final packaging.....................................................................................................................................................3 2.26......................................................................................................................................................................3 simple package....................................................................................................................................................3 2.27......................................................................................................................................................................3 specialist..............................................................................................................................................................3 2.28......................................................................................................................................................................3 personal protection equipment.............................................................................................................................3 PPE.....................................................................................................................................................................3 2.29......................................................................................................................................................................3 mass explosion....................................................................................................................................................3 2.30......................................................................................................................................................................3 unstable explosives.............................................................................................................................................3 2.31......................................................................................................................................................................3 supplier................................................................................................................................................................3
ABNT NBR 14725-2:2009

2.32......................................................................................................................................................................3 flammable gas.....................................................................................................................................................3 2.33......................................................................................................................................................................3 oxidant gas..........................................................................................................................................................3 2.34......................................................................................................................................................................4 gas under pressure..............................................................................................................................................4 2.35......................................................................................................................................................................4 biological indicator of exposure............................................................................................................................4 2.36......................................................................................................................................................................4 in vitro..................................................................................................................................................................4 2.37......................................................................................................................................................................4 in vivo..................................................................................................................................................................4 2.38......................................................................................................................................................................4 confidential information........................................................................................................................................4 2.39......................................................................................................................................................................4 component...........................................................................................................................................................4 2.40......................................................................................................................................................................4
skin irritation.........................................................................................................................................................4 2.41......................................................................................................................................................................4 ocular irritation.....................................................................................................................................................4 2.42......................................................................................................................................................................4 irritant...................................................................................................................................................................4 2.43......................................................................................................................................................................4 Kow......................................................................................................................................................................4 2.44......................................................................................................................................................................4 serious eye lesion................................................................................................................................................4 2.45......................................................................................................................................................................4 concentration limit................................................................................................................................................4 2.46......................................................................................................................................................................5 occupational exposure limit..................................................................................................................................5 2.47......................................................................................................................................................................5 mixture.................................................................................................................................................................5 2.48......................................................................................................................................................................5 mobility into the soil.............................................................................................................................................5 2.49......................................................................................................................................................................5
ABNT NBR 14725-2:2009

mutation...............................................................................................................................................................5 2.50......................................................................................................................................................................5 mutagenicity.........................................................................................................................................................5 2.51......................................................................................................................................................................5 mutagenic............................................................................................................................................................5 2.52......................................................................................................................................................................5 commercial name................................................................................................................................................5 2.53......................................................................................................................................................................5 chemical name.....................................................................................................................................................5 2.54......................................................................................................................................................................5 technical name.....................................................................................................................................................5 2.55......................................................................................................................................................................5 signal word...........................................................................................................................................................5 2.56......................................................................................................................................................................5 danger.................................................................................................................................................................5 2.57......................................................................................................................................................................5 persistence..........................................................................................................................................................5 2.58......................................................................................................................................................................6
pertinent...............................................................................................................................................................6 2.59......................................................................................................................................................................6 pictogram.............................................................................................................................................................6 2.60......................................................................................................................................................................6 2.61......................................................................................................................................................................6 chemical product..................................................................................................................................................6 2.62......................................................................................................................................................................6 program for safety, health and environment........................................................................................................6 2.63......................................................................................................................................................................6 target public.........................................................................................................................................................6 2.64......................................................................................................................................................................6 chemical residue..................................................................................................................................................6 2.65......................................................................................................................................................................6 risk.......................................................................................................................................................................6 2.66......................................................................................................................................................................6 labeling................................................................................................................................................................6 2.67......................................................................................................................................................................6
ABNT NBR 14725-2:2009

safety...................................................................................................................................................................6 2.68......................................................................................................................................................................6 skin sensitizer......................................................................................................................................................6 2.69......................................................................................................................................................................6 respiratory sensitizer............................................................................................................................................6 2.70......................................................................................................................................................................7 symbol.................................................................................................................................................................7 2.71......................................................................................................................................................................7 globally harmonized system.................................................................................................................................7 2.72......................................................................................................................................................................7 overwrapping.......................................................................................................................................................7 2.73......................................................................................................................................................................7 flammable solid....................................................................................................................................................7 2.74......................................................................................................................................................................7 substance............................................................................................................................................................7 2.75......................................................................................................................................................................7 emergency telephone..........................................................................................................................................7
2.76......................................................................................................................................................................7 make FISPQ (MSDS) documents available.........................................................................................................7 2.77......................................................................................................................................................................7 acute toxicity........................................................................................................................................................7 2.78......................................................................................................................................................................7 acute aquatic toxicity...........................................................................................................................................7 2.79......................................................................................................................................................................7 chronic aquatic toxicity.........................................................................................................................................7 2.80......................................................................................................................................................................7 toxicity to reproduction.........................................................................................................................................7 2.81......................................................................................................................................................................8 undue use............................................................................................................................................................8 2.82......................................................................................................................................................................8 user......................................................................................................................................................................8 Bibliography................................................................................................................................................................9 Foreword 15 Introduction...............................................................................................................................................................16 1 Scope 1
ABNT NBR 14725-2:2009

2 Normative references..............................................................................................................................................1 3 Terms and definitions..............................................................................................................................................1 4 Criteria for hazard classification of a chemical product - Mixtures and substances.................................................1 4.1 Mixtures.............................................................................................................................................................1 4.2 Test methods and data reliability.......................................................................................................................2 4.3 Previously classified chemicals ........................................................................................................................2 4.4 Substances/Mixtures posing special problems..................................................................................................2 4.5 Use of animals ..................................................................................................................................................2 4.6 Specialists judgment.........................................................................................................................................2 4.7 Evidence from humans .....................................................................................................................................2 4.8 Weight of evidence............................................................................................................................................2 4.9 Use of cut-off values/concentration limits..........................................................................................................3 4.10 Synergistic or antagonistic effects ..................................................................................................................3 4.11 Knowing the properties of substances and mixtures.......................................................................................3 4.12 Registration.....................................................................................................................................................3 4.13 Symbols for danger and warning words..........................................................................................................3 5 Hazard classification to the human health...............................................................................................................4 5.1 General considerations......................................................................................................................................4
5.2 Acute toxicity.....................................................................................................................................................4 5.2.1 Classification categories.............................................................................................................................4 5.2.2 Classification of mixtures where acute toxicity test data are available for the complete mixture ................5 Table 1 Categorias de toxicidade aguda e valores aproximados de DL50/CL50............................................5 5.2.3 Classification of mixtures where acute toxicity test data are not available for the complete mixture: Bridging principles...............................................................................................................................................7 5.2.4 Classification of mixtures based on its components - Additive Formula......................................................8 5.2.5 Decision logic Diagrams .............................................................................................................................................................................9 5.3 Skin irritation and corrosion.............................................................................................................................13 5.3.1 Classification categories...........................................................................................................................13 5.3.2 Substance - Corrosion..............................................................................................................................13 5.3.3 Substance - irritation.................................................................................................................................14 5.3.4 Classification criteria for mixtures.............................................................................................................14 5.3.5 Decision logic Diagrams...........................................................................................................................17 5.4 Serious eye damage / eye irritation ................................................................................................................21 5.4.1 Classification criteria for ingredients.........................................................................................................21 5.4.2 Classification criteria for mixtures ...........................................................................................................23
ABNT NBR 14725-2:2009

5.4.3 Decision logic Diagrams...........................................................................................................................26 5.5 Respiratory or skin sensitization......................................................................................................................29 5.5.1 Classification criteria for substances.........................................................................................................29 5.5.2 Classification criteria for mixtures ............................................................................................................29 5.5.3 Decision logic Diagram.............................................................................................................................30 5.6 Germ cell mutagenicity....................................................................................................................................33 5.6.1 Classification criteria.................................................................................................................................33 5.6.2 Classification criteria for mixtures.............................................................................................................34 5.6.3 Decision logic Diagrams...........................................................................................................................35 5.7 Carcinogenicity................................................................................................................................................37 5.7.1 Classification criteria.................................................................................................................................37 5.7.2 Classification criteria for mixtures.............................................................................................................38 5.7.3 Decision logic Diagrams...........................................................................................................................39 5.8 Toxicity to reproduction and lactation..............................................................................................................41 5.8.1 Classification criteria - Effects on reproductivity........................................................................................41 5.8.2 Classification categories - Effects on or via lactation................................................................................41 ..........................................................................................................................................................................41
5.8.3 Classification criteria for mixtures.............................................................................................................42 5.8.4 Decision logic Diagrams...........................................................................................................................43 5.9 Specific target organ systemic toxicity single exposure ..................................................................................47 5.9.1 Classification categories...............................................................................................................................47 5.9.2 Classification criteria for mixtures.............................................................................................................48 5.9.3 Decision logic Diagrams...........................................................................................................................49 5.10 Specific target organ systemic toxicity repeated exposure............................................................................52 5.10.1 Classification criteria...............................................................................................................................52 5.10.2 Classification criteria for mixtures...........................................................................................................54 5.10.3 Decision logic Diagrams.........................................................................................................................55 5.11 Aspiration hazard .........................................................................................................................................58 5.11.1 Classification criteria...............................................................................................................................58 5.11.2 Classification criteria for mixtures...........................................................................................................58 5.11.3 Decision logic diagrams ...........................................................................................................................................................................60 6 Hazardous to the aquatic environment .................................................................................................................61 6.1 General considerations....................................................................................................................................61 6.2 Classification criteria for substances...............................................................................................................61 6.3 Classification criteria for mixtures....................................................................................................................63
ABNT NBR 14725-2:2009

6.3.1 Flow diagram for classification.................................................................................................................63 6.3.2 Classification of mixtures when data are available for toxicity of aquatic organisms ................................64 6.3.3 Classification of mixtures when aquatic data assays are not available for the mixture: Bridging principles ...........................................................................................................................................................................64 6.3.4 Classification of mixtures when data are available for all components or only for some components of the mixture ..............................................................................................................................................................65 6.3.5 Classification procedure............................................................................................................................65 6.3.6 Classification for the Acute Categories 1, 2 and 3 ..................................................................................66 6.3.7 Classification for the Chronic Categories 1, 2, 3 and 4.............................................................................66 6.3.8 Mixtures with highly toxic components ....................................................................................67
6.3.9 Classification of mixtures with components without any useable information ..........................................67 6.4 Decision logic diagrams..................................................................................................................................67 7 Physical hazards....................................................................................................................................................73 7.1 General considerations....................................................................................................................................73 7.2 Classification criteria for substances, mixtures and explosive articles.............................................................73 7.3 Classification criteria for flammable gases......................................................................................................74 7.4 Classification criteria for flammable aerosols..................................................................................................75 7.5 Criteria for classification of oxidizing gases.....................................................................................................78
7.6 Criteria for classification of gases under pressure...........................................................................................79 7.7 Criteria classification for flammable liquids......................................................................................................81 7.8 Criteria classification for flammable solids.......................................................................................................82 7.9 Classification criteria for self-reactive substances and mixtures - Substances liable to spontaneous combustion............................................................................................................................................................84 7.10 Criteria classification for pyrophoric liquids....................................................................................................85 7.11 Criteria classification for pyrophoric solids.....................................................................................................86 7.12 Classification criteria for self-heating substances and mixtures ...................................................................86 7.13 Classification criteria for substances and mixtures which, in contact with water, emit flammable gases.......88 7.14 Criteria classification for oxidizing liquids......................................................................................................90 7.15 Criteria classification for oxidizing solids.......................................................................................................92 7.16 Classification criteria for organic peroxides...................................................................................................94 7.17 Classification criteria for substances and mixtures corrosive to metals.........................................................95 Anexo A (informativo) Mtodos de ensaios..............................................................................................................96 Bibliography..............................................................................................................................................................98 Foreword 5 Introduction.................................................................................................................................................................6 1 Scope 1
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2 Normative references..............................................................................................................................................1 3 Terms and definitions..............................................................................................................................................1 4 General considerations............................................................................................................................................1 5 Safety information for the labeling hazardous chemicals.........................................................................................2 6 Product label specifications.....................................................................................................................................2 Anexo A (informativo) Correlao entre as informaes da FISPQ e da rotulagem de produto qumico perigoso.....4 Anexo B (normativo) Instrues para incluso das informaes de segurana no rtulo do produto qumico perigoso 5 B.1 Product identification and supplier emergency telephone....................................................................................5 B.2 Chemical composition..........................................................................................................................................5 B.3 Hazard pictograms...............................................................................................................................................5 B.4 Signal words.........................................................................................................................................................6 B.5 Hazard statement.................................................................................................................................................6 B.6 Precautionary statements.....................................................................................................................................6 B.7 Other information..................................................................................................................................................6 Anexo C (normativo) Smbolos de perigo...................................................................................................................7 Anexo D (normativo) Pictogramas de perigo, palavras de advertncia e frases de perigo.........................................8 Table D.1 Explosives.......................................................................................................................................8
Table D.2 Flammable gases...........................................................................................................................8 Table D.3 Flammable aerosols.......................................................................................................................9 Table D.4 Oxidizing gases..............................................................................................................................9 Table D.5 Gases under pressure....................................................................................................................9 Table D.6 Flammable liquids.........................................................................................................................10 Table D.7 Flammable solids..........................................................................................................................10 Table D.8 Self-reactive substances and mixtures.........................................................................................10 Table D.9 Pyrophoric liquids ........................................................................................................................11 Table D.10 Pyrophoric Solids........................................................................................................................11 Table D.11 Self-heating substances and mixtures .......................................................................................11 Table D.12 Substances and mixtures that emit flammable gases in contact with water ..........................................................................................................................................................................12
Table D.13 Oxidizing liquids..........................................................................................................................12 Table D.14 Oxidizing solids...........................................................................................................................12 Table D.15 Organic peroxides.......................................................................................................................13 Table D.16 Corrosive to metals.....................................................................................................................13 Table D.17 Acute toxicity - Oral.....................................................................................................................13
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Table D.18 Acute toxicity - Skin ..................................................................................................................14 Table D.19 Acute toxicity - Inhalation...........................................................................................................14 Table D.20 Skin corrosive/Irritant..................................................................................................................14 Table D.21 Serious eye damage/eye irritation..............................................................................................15 Table D.22 Respiratory sensitization.............................................................................................................15 Table D.23 Skin sensitization........................................................................................................................15 Table D.24 Mutagenicity................................................................................................................................16 Table D.25 Carcinogenicity...........................................................................................................................16 Table D.26 Toxic to reproduction..................................................................................................................17 Table D.27 Specific target organ systemic toxicity (single exposure)............................................................17 Table D.28 Specific target organ systemic toxicity (repeated exposure) ......................................................18 Table D.29 Aspiration hazard........................................................................................................................18 Table D.30 Hazard to aquatic environment...................................................................................................19 Table D.31 Aquatic toxicity (chronic).............................................................................................................19 Anexo E (informativo) Frases de precauo.............................................................................................................20 Table E.1 Physical hazard statements..........................................................................................................21 Table E.1 (continuing)........................................................................................................................................22 Table E.1 (continuing)........................................................................................................................................23
Table E.2 Statements to prevent potential misuse and exposure to health ..................................................24 Table E.3 Statements explaining appropriate action in the event of an accident..........................................25 Table E.4 Statements for environmental protection and appropriate disposal .............................................27 Anexo F (informativo) Exemplos ilustrativos de rtulos............................................................................................28 F.1 Combination packaging for a Category 2 flammable liquid.................................................................................28 Figure F.1 Outer packaging: Box with transport label for flammable liquid (Risk Class 3) (see ABNT NBR 7500).......................................................................................................................................................28 Figure F.2 Inner packaging: flammable liquid glass bottle with GHS label (Category 2) (see 5.1)........................................................................................................................................29 F.2 Inner packaging: Category 2 flammable liquid and Category 2 skin irritant ......................................................30 Figure F.3 Inner packaging: 200 L drum with GHS label and transport label................................................30 F.3 Overwrapping with two combined packages: one with flammable liquid Category 2 and another containing a skin irritant Category 2..............................................................................................................................................31 Figure F.4 Overwrapping: cardboard box with GHS label and transport label................................................31 F.4 Product label......................................................................................................................................................32 Figure F.5 Product classified as Category 2 flammable liquid, acute inhalation toxicity category 4 and systemic toxicity through repeated exposure category 2 to the target organ.....................................................34 Bibliography..............................................................................................................................................................35 Foreword 5
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Introduction.................................................................................................................................................................6 1 Scope 1 2 Normative references..............................................................................................................................................1 3 Terms and definitions..............................................................................................................................................1 4 General considerations............................................................................................................................................1 5 Content and general model of a FDS......................................................................................................................2 Anexo A (normativo) Instrues para a elaborao de uma FISPQ...........................................................................4 1. Identification of the substance or mixture and of the supplier .............................................................................4 2. Hazards identification..........................................................................................................................................4 3. Composition/information on ingredients .............................................................................................................5 Table A.1 - Cut-off values/Concentration limits for each health and environmental hazard class........................5 4. First aid measures...............................................................................................................................................6 5. Fire-fighting measures.........................................................................................................................................6 6. Accidental release control of spilling and leakage...............................................................................................6 7. Handling and storage..........................................................................................................................................6 8. Exposure controls/personal protection. ..............................................................................................................7 9. Physical and chemical properties........................................................................................................................8
10. Stability and reactivity........................................................................................................................................9 11. Toxicological information ................................................................................................................................10 12. Ecological information.....................................................................................................................................11 13. Considerations regarding treatment and disposal ..........................................................................................12 The user should be reminded about the possible existence of local regulations for treatment and disposal.........12 14. Transport information......................................................................................................................................12 15. Regulations.....................................................................................................................................................13 16. Other information.............................................................................................................................................13 Heading (at the beginning of every page)..............................................................................................................14 1. Identification of the substance or mixture and identification of the supplier.......................................................14 2. Hazards identification........................................................................................................................................14 3. Composition and Information on Ingredients.....................................................................................................15 4. First-aid measures.............................................................................................................................................15 5. Fire-fighting measures.......................................................................................................................................15 6. Spill / leakage prevention control.......................................................................................................................15 7. Handling and storage........................................................................................................................................16 8. Exposure controls / personal protection............................................................................................................17 9. Physical and chemical properties......................................................................................................................17
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10. Stability and reactivity......................................................................................................................................18 11. Toxicological information.................................................................................................................................18 12. Ecological information.....................................................................................................................................18 13. Disposal and treatment considerations............................................................................................................18 14. Transport information......................................................................................................................................19 15. Regulations.....................................................................................................................................................19 16. Other information.............................................................................................................................................19 Bibliography..............................................................................................................................................................20
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Foreword
The Brazilian Association of Technical Standards ABNT (Associao Brasileira de Normas Tcnicas) is the National Forum of Standardization. The Brazilian Standards, whose content is under the responsibility of the Brazilian Committees (ABNT/CB), Sectorial Standardization Organisms (ABNT/ONS) and Special Study Committees (ABNT/CEE), are worked out by Study Committees (CE) composed of representatives from the involved sectors, such as: Producers, consumers and neutral entities (universities, laboratories and others). The ABNT technical documentation is made according to the rules set forth in the ABNT Guidelines, Part 2. The Brazilian Association of Technical Standards (ABNT) emphasizes that some elements of this document may have patent protection. ABNT should not be held responsible to point out any patent rights. The Standard ABNT NBR 14725-2 has been worked out within the Brazilian Committee of Chemistry (ABNT/CB10) by members of the Committee for Information Studies on Safety, Health and Environment related to Chemicals (CE-10:101.05). Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-003, whereas the 2nd. Project was also sent to Nationwide Query through the Invitation to Bid no 09, carried out from 09/02/2008 until 01.10.2008 named 2nd for Project 10:101.05-003. The ABNT NBR 14725 standard entitled Chemical Products - Information on Safety, Health and Environment ("Produtos qumicos - Informaes sobre segurana, sade e meio ambiente") is expected to approach the following: Part 1: Terminology; Part 2: Hazard Classification System; Part 3: Labeling; Part 4: Material Safety Data Sheet - MSDS
WARNING - Other classification systems, besides those described in this part of ABNT NBR 14725, may be used until 02.26.2011. After 02/27/2011, all chemicals should be classified only in accordance with this part of ABNT NBR 14725 (ABNT NBR 14725-2:2009). This ABNT NBR 14725-2 first edition, jointly with Parts 1, 3 and 4, supersedes and cancel the ABNT NBR 14725:2005 print, which has been technically revised and dismembered in parts.
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Introduction
The production and use of chemical products are essential in global economic development; however, such products may pose a risk to the human health and to the environment if not used responsibly. Therefore, the primary objective of the Hazard Classification System for Chemicals is to provide information to protect the human health and the environment. An essential step for the safe use of chemicals is the identification of specific hazards jointly with the organization of such information as well, so that they can be clearly transmitted and easily understood by the users. Consequently, security measures can be taken to minimize and manage potential risks in circumstances where an exposure might occur. The United Nations (UN) Conference on Environment and Sustainable Development (UNCED) identified in 1992 that the classification of chemicals should be unified so that the associate risks could be communicate through Safety Data Sheets for chemicals, and easily identifiable labels and symbols. For this purpose, the Globally Harmonized System (GHS) was created in order to increase the protection of the human health and environment, to provide an internationally comprehensible system for risk communication, and to facilitate the international trade of chemicals as well, whose hazards were properly assessed and identified on international basis. The Decree 2657 of July, 3rd, 1998, which issued the Convention No.170 of the International Labor Organization (ILO), sets forth in article 6th that: "the competent authority, body or bodies approved or recognized by the competent authority in accordance with national or international standards, should establish systems and specific criteria appropriate to classify all chemicals according to the type and degree of physical risks and health risks they pose, and to assess the relevance of the information required to determine their dangerousness".
ABNT NBR 14725 is part of the effort to implement the Globally Harmonized System (GHS) of information security on hazardous chemicals. The unified Chemicals Hazard Classification System intends to be simple and transparent, aiming at allowing a clear distinction between the different categories of risk, thus facilitating the classification procedure. For several categories, the criteria are either qualitative or nearly quantitative, and an expert opinion is needed to interpret the data for purposes of classification. The labeling criteria for substances and mixtures according to the classification criteria as defined in this part of ABNT NBR 14725 is specified in ABNT NBR 14725-3. The diagrams included in this part of ABNT NBR 14725 are provided only as general guidance. This part of the ABNT NBR 14725 was based on the following GHS basic assumptions: There is a need to provide information on hazardous chemicals concerning safety, health and environment; The target public has the right to know and identify the hazardous chemicals they use and the dangers they offer; A simple and easy to understand system of identification should be applied in the different locations where the hazardous chemicals are used;
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Such system should be compatible with the classification criteria for all hazards that might be anticipated by GHS; International agreements should be facilitated and industrial secrets and confidential information should be protected; There is a need to train workers and to improve their capability and, It is required to foster users' education and awareness.
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BRAZILIAN STANDARD
ABNT NBR 14725-2:2009
Chemicals Information about safety, health and environment Part 2: Hazard Classification System
1 Scope
This part of ABNT NBR 14725 establishes the criteria for the Chemicals Hazard Classification System, whether they are substances or mixtures in order to provide the user with information related to security, human health and environment. This part of ABNT NBR 14725 applies to all chemicals (pure chemical substances and their mixtures thereof). NOTE It is necessary to check the mandatory application of this part of ABNT NBR 14725 if the chemical substance must be in compliance with the provisions of specific legislation.
2 Normative references
The following documents are indispensable to the application of this Standard. Dated references are applicable only to the mentioned editions. For undated references, the latest reference should be applied (including amendments).
ABNT NBR 14725-1, Chemicals Information about safety, health and environment Part 1: Terminology ABNT NBR 14725-3, Products chemical - Information about safety, health and environment Part 3: Labeling ABNT NBR 14725-4, Chemicals Information about safety, health and environment Part 4: Material Safety Data Sheet - MSDS (Ficha de Informaes de Segurana de Produtos Qumicos FISPQ Brazil). GHS book, Globally Harmonized System of Classification and Labeling of Chemicals (GHS) - Purple Book, 2005. Recommendation on the transports of dangerous goods, Manual of Tests and Criteria, United Nations
3 Terms and definitions

This part of ABNT NBR 14725 uses the terms and definitions of ABNT NBR 14725-1.
4 Criteria for hazard classification of a chemical product Mixtures and substances

4.1 Mixtures
Where test data are available for the mixture, the classification of the mixture will always be based on that data. The established criteria for classification of mixtures allow the use of the available data for the mixture itself and/or mixtures substantially similar (see 5.2.3.5) and/or data of the mixture ingredients.
ABNT NBR 14725-2:2009

Where test data are not available for the mixture itself, then bridging principles included and explained in each specific chapter should be considered to see whether they permit classification of the mixture. If test data are not available for the mixture, and the available information is not sufficient to allow application of the bridging principles, then the method(s) described in Annex A f will be applied to estimate the hazard classify the mixture.
4.2
Test methods and data reliability
The classification of a chemical substance or mixture depends both on the criteria and on the reliability of the test methods underpinning the criteria. In some cases the classification is determined by a pass or fail of a specific test, (e.g. the ready biodegradation test for substances or ingredients of mixtures), while in other cases, interpretations are made from dose/response curves and observations during testing. In all cases, the test conditions need to be standardized so that the results are reproducible with a given chemical substance and the standardized test yields valid data for defining the hazard class of concern. In this context, validation is the process by which the reliability and the relevance of a procedure are established for a particular purpose. Tests that determine hazardous properties should be carry out following the GLP (Good Laboratory Practices) , according to internationally validated recognized scientific principles, and can be used for hazard determination to the health and to the environment.
4.3
Previously classified chemicals
One of the general principles established by GHS states that test data already generated and internationally recognized for classification of chemicals in other systems, should be accepted to avoid duplicative testing and the unnecessary use of test animals.
4.4
Substances/Mixtures posing special problems
The effect of a substance or mixture on biological and environmental systems is influenced, among other factors, by the physico-chemical properties of the substance or mixture and/or ingredients of the mixture and the way in which ingredient substances are biologically available. Some groups of substances may present special problems in this respect, for example, some polymers and metals. A substance or mixture need not be classified when it can be shown by conclusive experimental data from internationally acceptable test methods that the substance or mixture is not biologically available. Similarly, bioavailability data on ingredients of a mixture should be used where appropriate in conjunction with the harmonized classification criteria when classifying mixtures.
4.5
Use of animals
Where possible and appropriate, tests and experiments that do not require the use of live animals are preferred to those using sentient live experimental animals. To that end, for certain hazards (skin irritation/corrosion and eye irritation/serious eye damage) testing schemes starting with non-animal observations/measurements are included as part of the classification system. For other hazards, such as acute toxicity, alternative animal tests, using fewer animals or causing less suffering are internationally accepted and should be preferred to the conventional LD50 test.
4.6
Specialists judgment
The approach to classifying mixtures includes the application of expert judgment in a number of areas in order to ensure existing information can be used for as many mixtures as possible to provide protection for human health and the environment.
4.7
Evidence from humans
For classification purposes, reliable epidemiological data and experience on the effects of chemicals on humans (e.g. occupational data, data from accident databases) should be taken into account in the evaluation of human health hazards of a chemical. Testing on humans solely for hazard identification purposes is generally not acceptable.
4.8
Weight of evidence
For some hazard classes, classification results directly when the data satisfy the criteria in this ABNT NBR 14725 section. For others, classification of a substance or a mixture is made based on data consistency and weight of evidence. This means that all available information bearing on the determination of toxicity is considered together,
ABNT NBR 14725-2:2009

including the results of studies on sites, mechanisms and courses of action. Both positive and negative results are assembled together in a single weight of evidence determination. Positive effects that are consistent with the criteria for classification outlined in 5.2 a 5.11, whether seen in humans or animals, will normally justify classification. Where evidence is available from both sources and there is a conflict between the findings, the quality and reliability of the evidence from both sources must be assessed in order to resolve the question of classification. Generally, data of good quality and reliability in humans will have precedence over other data. A single positive study performed according to GLP and with statistically and biologically significant positive results may justify the classification of a product or mixture.
4.9
Use of cut-off values/concentration limits
When classifying an untested mixture based on the hazards of its ingredients, cut-off values or concentration limits already established are used in GHS. While the adopted cut-off values/concentration limits adequately identify the hazard for most mixtures, there may be some that contain hazardous ingredients at lower concentrations than those included in this part of ABNT NBR 14725 standard, but that still pose an identifiable hazard. There may also be cases where the established cut-off value/concentration limit is lower than could be expected based in an established non-hazardous level for an ingredient. If the available information indicates that the hazard posed by certain ingredient is evident even below the cut-off values/concentration limit, the mixture containing that ingredient should be classified accordingly. Occasionally, conclusive data may show that the hazard of an ingredient will not be evident when present at a level above the GHS cut-off values/concentration limit(s). In these cases, the mixture could be classified according to those data. The data should exclude the possibility that the ingredient would behave in the mixture in a manner that would increase the hazard over that of the pure substance. Furthermore, the mixture should not contain ingredients that would affect that determination.
Adequate documentation supporting the use of any values other than the generic cut-off values/concentration limits should be retained and made available for review on request.
4.10 Synergistic or antagonistic effects

When performing an assessment in accordance with the ABNT NBR 14725 Standard requirements, the evaluator must take into account all available information about the potential occurrence of synergistic effects among the ingredients of the mixture. Lowering classification of a mixture to a less hazardous category because of antagonistic effects may be done only if the determination is supported by sufficient data.
4.11 Knowing the properties of substances and mixtures

The evaluation of the hazard of pure substances and their mixtures is accomplished based on the properties indicating effects on health, environment and considering their physical and chemical properties.
4.12 Registration
All procedures and records used and generated during the classification must be filed and made available when required.
4.13 Symbols for danger and warning words

The use of hazard symbols and words of warning are illustrated in Figures in this part of ABNT NBR 14725 and detailed presented in ABNT NBR 14725-3.
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5 Hazard classification to the human health

5.1 General considerations
The hazards of substances and mixtures on health are determined by evaluation of their toxicological properties, in accordance with the criteria described in this part of ABNT NBR 14725 and methodologies described in the UN Manual of Tests and Criteria (see Annex A). Besides that, the hazards of substances and mixtures can be demonstrated through: Epidemiological studies from scientifically valid case or by statistically supported experience, such as evaluations from centers of intoxication or information concerning occupational diseases databases; Toxicological effects in humans that differ from those suggested by experimental laboratory methods are referenced in Appendix A and should be classified according to the symptoms observed in humans Synergistic, potentiation, or added effects that should be considered in classifying a mixture when a conventional assessment leads to an underestimation of the toxicological hazard. The same applies to antagonistic effects that might have been overestimated.
When the formula is modified from a mixture, with a variation in mass or volume, a new evaluation and classification of its hazard should be performed. Therefore, such new assessment only is not applicable if scientific evidence is pointing out for the need of a reassessment of the hazards will not result in changing the classification. Regarding the classification of mixtures, one can estimate its toxicity based on the toxicological knowledge of the ingredients present. This estimate can also be done using several well-known national and international models, such as the OSHA of the European Community Directive, among others.
5.2
5.2.1
Acute toxicity
Classification categories
The hazard classification of substances and mixtures is based on cut-off values / concentration limits of the values of acute oral, dermal and inhalation, the LD50 and LC50, which are obtained by testing with mammals, according to the methods described in Annex A. These limits substances and mixtures are classified into categories of hazards.
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5.2.2 Classification of mixtures where acute toxicity test data are available for the complete mixture
Chemical products and mixtures may be classified in one out of five categories of acute toxicity by oral, dermal or inhalation routes according to Table 1.
Table 1 Categorias de toxicidade aguda e valores aproximados de DL50/CL50

Exposure routes Oral a mg/kg bodyweight Dermal a mg/kg bodyweight Gases a b L/L (ppm) Vapors a b c d mg/L Dust and mist a b e mg/L
a
Approximate Upper limits of LD50/LC50 Category 1 5 50 100 0.5 0.05 Category 2 50 200 500 2.0 0.5 Category 3 300 1 000 2 500 10 1.0 Category 4 2 000 2 000 5 000 20 5 5 000 f Category 5
The acute toxicity estimate (ATE) for the classification of a substance or ingredient in a mixture is derived using: the LD50/LC50 where available, the appropriate conversion value from Table 2, which relates to the results of a range test, or the appropriate conversion value from Table 2 that relates to a classification category. b Inhalation cut-off values in the Table is based on 4 hour testing exposures. If the existing inhalation toxicity data have been generated according to 1-hour exposures, the values of LC50 should be divided by a factor of 2 for gases and vapors, and 4 for dusts and mists. c It is recognized that saturated vapor concentration may be used as an additional element by some regulatory systems to provide for specific health and safety protection. (e.g. UN Recommendations for the Transport of Dangerous Goods). d For some chemicals the test atmosphere will not just be a vapor but will consist of a mixture of liquid and vapor phases. In these cases, classification should be based on microliter per liter (ppm) as follows: category 1, 100 L/L (ppm); category 2, 500 L/L (ppm); category 3, 2500 L/L (ppm); category 4, 5000 L/L (ppm). Methods from Annex A are performed aiming at a better definition of such terms as dusts, mists and vapors, regarding the toxicity tests by respiratory route. e The values for dusts and mists should be reviewed to adapt to any future changes to the ones in Annex A with respect to technical limitation in generating, maintaining and measuring dust and mist concentrations in respirable form. f Criteria for Category 5 are intended to enable the identification of substances which are of relatively low acute toxicity hazard but which under certain circumstances may present a danger to vulnerable populations. These substances are anticipated to have an oral or dermal LD50 in the range of 2000-5000 mg/kg bodyweight and equivalent doses for inhalation. The specific criteria for Category 5 are: a) The substance is classified in this Category if reliable evidence is already available that indicates the LD50 (or LC50) to be in the range of Category 5 values or other animal studies or toxic effects in humans indicate a concern for human health of an acute nature; b) The substance is classified in this Category, through extrapolation, estimation or measurement of data, if assignment to a more hazardous category is not warranted, and: 1) reliable information is available indicating significant toxic effects in humans; or 2) any mortality is observed when tested up to Category 4 values by the oral, inhalation, or dermal routes; or 3) where expert judgment confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhea, piloerection or an ungroomed appearance; or 4) where expert judgment confirms reliable information indicating the potential for significant acute effects from other animal studies.
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When the mixture itself is tested for acute toxicity it may be classified according to criteria set for substances in Table 2. Table 2 Conversion from experimentally obtained acute toxicity range values to acute toxicity category, for the different routes of exposure Exposure routes Oral LD50 mg/kg bodyweight Experimentally obtained acute toxicity ranges Classification category a 0 < Category 1 5 5 < Category 2 50 50 < Category 3 300 300 < Category 4 2 000 2 000 < Category 5 5 000 0 < Category 1 50 50 < Category 2 200 200 < Category 3 1 000 1 000 < Category 4 2 000 2 000 < Category 5 5 000 0 < Category 1 100 100 < Category 2 500 500 < Category 3 2 500 2 500 < Category 4 5 000 Category 5 a 0 < Category 1 0,5 0,5 < Category 2 2,0 2,0 < Category 3 10,0 10,0 < Category 4 20,0 Category 5 a 0 < Category 1 0,05 0,05 < Category 2 0,5 0,5 < Category 3 1,0 1,0 < Category 4 5,0 Category 5 a Converted Acute Toxicity point estimate 0.5 5 100 500 2 500 5 50 300 1100 2 500 10 100 700 3 000 0.05 0.5 3 11 0.005 0.05 0.5 1.5 b
Dermal LD50 mg/kg bodyweight
Gases LC50 L/L (ppm)
Vapors LC50 mg/L
Dust/mist LC50 mg/L
Category 5 is for mixtures which are of relatively low acute toxicity but which under certain circumstances may pose a hazard to vulnerable populations. These mixtures are anticipated to have an oral or dermal LD50 value in the range of 2000-5000 mg/kg bodyweight or equivalent dose for other routes of exposure. In light of animal welfare considerations, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such testing would have a direct relevance for protecting human health. b These values are designed to be used in the calculation of the ATE for classification of a mixture based on its components (see Formulas 1 and 2) and do not represent test results. The values are conservatively set at the lower end of the range of Categories 1 and 2, and at a point approximately 1/10th from the lower end of the range for Categories 3 5.
Recognizing the need to protect animal welfare, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such a test would have a direct relevance for protecting human health.
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If test data for the mixture are not available, the procedures pointed out in 5.2.3 should be followed. 5.2.3 Classification of mixtures where acute toxicity test data are not available for the complete mixture: Bridging principles
NOTE Where the mixture itself has not been tested to determine its acute toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 5.2.3.1 Dilution If a mixture is diluted with a substance that has an equivalent or lower toxicity classification than the least toxic original ingredient, and which is not expected to affect the toxicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture. Alternatively, the formula (1) (see Figure 2) could be applied. If a mixture is diluted with water or other totally non-toxic material, the toxicity of the mixture can be calculated from test data on the undiluted mixture. For example, if a mixture with an LD 50 of 1000 mg/kg bodyweight were diluted with an equal volume of water, the LD50 of the diluted mixture would be 2000 mg/kg bodyweight. 5.2.3.2 Batching
The toxicity of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product, and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the toxicity of the batch has changed. If the latter occurs, new classification is necessary. 5.2.3.3 Concentration of highly toxic mixtures
If a mixture is classified in Category 1, and the concentration of the ingredients of the mixture that are in Category 1 is increased, the new mixture should be classified in Category 1 without additional testing. 5.2.3.4 Interpolation within one toxicity category
For three mixtures with identical ingredients, where A and B are in the same toxicity category and mixture C has the same toxicologically active ingredients with concentrations intermediate to the concentrations of those ingredients in mixtures A and B, then mixture C is assumed to be in the same toxicity category as A and B. 5.2.3.5 Substantially similar mixtures
Given the following: a) Two mixtures: 1) 2) b) c) d) A + B; C + B;
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the toxicity of B.
Then there is no need to test mixture (2) if mixture (1) is already characterized by testing and both mixtures would be classified in the same category. 5.2.3.6 Aerosols An aerosol form of a mixture may be classified in the same hazard category as the tested, non-aerosolized form of the mixture for oral and dermal toxicity provided the added propellant does not affect the toxicity of the mixture on spraying. Classification of aerosolized mixtures for inhalation toxicity should be considered separately.
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5.2.4 5.2.4.1 Classification of mixtures based on its components - Additive Formula Data are available for all components
To ensure that the classification of the mixture is accurate and that the calculations will be perform only once for all systems, sectors and categories, the estimated acute toxicity (ETA) of the components should be considered as follows: Include ingredients with a known acute toxicity, which fall into any of the known toxicity categories; Ignore ingredients that are presumed not acutely toxic (e.g. water, sugar); Ignore ingredients if the oral limit test does not show acute toxicity at 2000 mg/kg bodyweight.
Ingredients that fall within the scope of this paragraph are considered ingredients with a known acute toxicity estimate. The ETA of the mixture is determined by calculation from the ETA values for all relevant ingredients according to the following formula (1) below for oral, dermal or inhalation toxicity:
Formula (1) where: n ETAi ETAm Ci 5.2.4.2 number of components, and i is running from 1 to n; Acute Toxicity Estimate of ingredient i; Acute Toxicity Estimate of mixture m; concentration of component i . Data are not available for one or more ingredients of the mixture
5.2.4.2.1 Where an ATE is not available for an individual ingredient of the mixture, but available information such as listed below can provide a derived conversion value, the formula in (1) may be applied. This may include evaluation of: Analogies among estimates for oral, dermal and inhalation acute toxicity. Such evaluation may require appropriate data from pharmacodynamics and farmacokinetics. For ingredients with acute toxicity estimates available for other than the most appropriate exposure route, values may be extrapolated from the available exposure route to the most relevant route. Dermal and inhalation route data are not always required for ingredients. However, in case data requirements for specific ingredients include acute toxicity estimates for the dermal and inhalation route, the values to be used in the formula need to be from the required exposure route; Evidence from human exposure that indicates toxic effects but does not provide lethal dose data; Evidence from any other toxicity tests/assays available on the substance that indicates toxic acute effects but does not necessarily provide lethal dose data; or Data from closely analogous substances using structure/activity relationships.
5.2.4.2.2 This approach generally requires substantial supplemental technical information, and a highly trained and experienced expert, to reliably estimate acute toxicity. If such information is not available, proceed to the provisions of 5.2.4.2.4. 5.2.4.2.3 In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1% or greater, it is concluded that the mixture cannot be attributed a definitive ETA. In this situation, the mixture should be classified based on the known ingredients only, with the additional statement that x percent of the mixture consists of ingredient(s) of unknown toxicity. 5.2.4.2.4 If the total concentration of the ingredient(s) with unknown acute toxicity is 10% then the formula (1) should be used. If the total concentration of the ingredient(s) with unknown toxicity is >10%, the formula (1) should be corrected to adjust for the total percentage of the unknown ingredient(s) as follows in formula (2):
ABNT NBR 14725-2:2009

Formula (2) Where Cd ETAm n Ci ETAi 5.2.5 is the concentration of ingredients of unknown acute toxicity; is the Acute Toxicity Estimate of mixture m; number of components, and i is running from 1 to n; concentration of component i. is the Acute Toxicity Estimate of ingredient i.
Decision logic Diagrams
Figures 1 and 2 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
ABNT NBR 14725-2:2009

Substance: Are there data and/or information to evaluate acute toxicity? No Classification not possible
Yes
Mixture: Does the mixture as a whole have data/information to evaluate acute toxicity? Yes
No
Classification not possible
Mixture: Does the mixture as a whole have data/information to evaluate acute toxicity? Yes
No
Calcule ETA for mixture (see Figure 2)
ETA (from Figure 2)
Oral LD50 5 mg/kg bodyweight, or Dermal LD50 50 mg/kg bodyweight, or Inhalation (gas) LC50 100 L/L (ppm), or Inhalation (vapor) LC50 0.5 mg/L, or Inhalation (dust/mist) LC50 0.05 mg/L?
Category 1 Yes Danger
No
Oral LD50 > 5 but < 50 mg/kg bodyweight, or Dermal LD50 > 50 but 200 mg/kg bodyweight, or Inhalation (gas) LC50>100 L/L (ppm) but 500 L/L (ppm); or Inhalation (vapor) LC50 > 0.5 mg/L but 2.0 mg/L; or Inhalation (dust/mist) LC50 > 0.05 mg/L e 0.5 mg/L?
No
Category 3
Oral LD50 > 5 mg/kg but 300 mg/kg bodyweight; or Dermal LD50 > 200 mg/kg but 1 000 mg/Kg bodyweight; or Inhalation (gas) LC50 > 500 L/L (ppm) but 2 500 L/L (ppm); or Inhalation (vapor) LC50 > 2 mg/L but 10 mg/L; or Inhalation (dust/mist) LC50 > 0.5 mg/L but 1.0 mg/L?
Yes Danger
Figure 1 Decision logic for acute toxicity
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ABNT NBR 14725-2:2009
No Category 4 Yes Warning
Oral LD50 > 300 mg/kg but 2000 mg/Kg bodyweight, or Dermal LD50 > 1000 mg/kg but 2000 mg/Kg bodyweight, or Inhalation (gas) LC50 > 2500 L/L (ppm) but 5000 L/L (ppm), or Inhalation (vapor) LC50 > 10 mg/L but 20 mg/L, or Inhalation (dust/mist) LC50 > 1 mg/L but 5 mg/L? No
Oral LD50 > 2 000 but 5 000 mg/kg bodyweight, or Dermal LD50 > 2 000 mg/kg but 5 000 mg/kg bodyweight, or Inhalation (gas and/or vapor and/or dust/mist) LC50 in the equivalent range of the oral and dermal LD50 ( i.e., 2 000-5 000 mg/kg bodyweight? No
Category 5 Yes Warning
Is there reliable information available indicating significant toxicity effects in humans?; or Was any mortality observed when tested up to Category 4 values by the oral, inhalation or dermal routes?; or Is there expert judgment that confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhea, piloerection or an ungroomed appearance?; or Is there expert judgment that confirms reliable information indicating the potential for significant acute effects by the product?
Category 5 Yes
if assignment to a more hazardous class is not warranted
No
Not classified
Figura 1 (continuing)
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ABNT NBR 14725-2:2009
Can bridging principles be applied? No
Yes
Classify in appropriate category
Is acute toxicity data available for all ingredients of mixture? No
Yes
Is it possible to estimate a missing ETA(s) of the ingredients? Meaning, can conversion value(s) be derived? No
Yes
Apply Formula (1), Acute Toxicity Estimate, to calculate the ETA of the mixture
Go to Formula 1
Is the total concentration of the ingredient(s) with unknown acute toxicity >10 %? Yes a
No
Apply formula (2) to calculate the ETA
Go to Formula 2
In the event that an ingredient without any useable information is used in a mixture at a concentration > 1%, the classification should be based on the ingredients with the known acute toxicity only, and an additional statement on the label should identify the fact that the acute toxicity of x percent of the mixture is unknown. Figure 2 Decision logic for acute toxicity - ETA mixtures
12
ABNT NBR 14725-2:2009 5.3 Skin irritation and corrosion
5.3.1 Classification categories The classification of substances and mixtures in the various categories related to skin irritation and corrosion is shown in Tables 3 and 4. Category 1 has 3 subcategories (see Table 3). Table 3 Skin corrosive category and subcategories Corrosive in 1 of 3 animals Exposure t 3 minutes t > 3 minutes t 1 hour t > 1 hour 4 hours Observation t 1 hour t 14 days t 14 days
Category 1
Corrosive subcategories 1A
Skin corrosive effect
1B 1C
NOTE t is the exposure or observation time
Table 4 Skin irritation categories Categories Criteria Mean value of 2.3 < 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals; or In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Irritant (Category 2)
Mean value of 1.5 < 2.3 for erythema/eschar or for oedema from gradings in at least 2 of 3 tested animals from grades at 24, 48 and 72 Mild irritant hours after patch removal or, if reactions are delayed, from grades on 3 (Category 3) consecutive days after the onset of skin reactions (when not included in the irritant category above). NOTE Animals can be tested using methods outlined in Annex A. 5.3.2 Substance - Corrosion
A single harmonized corrosion category is provided in Table 3, using the results of animal testing. Category 1 has three subcategories according to Table 3: 1A: where responses are noted following up to 3 minutes exposure and up to 1 hour observation; 1B: where responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days; and 1C: where responses occur after exposures between 1 hour and 4 hours and observations up to 14 days.
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5.3.3 Substance - irritation
Irritant and mild irritant categories are pointed out in Table 4, which: describes the criteria for both categories of skin irritation (2 and 3) differentiated primarily by the severity of skin reactions; represents an average of the values used in the existing classifications; represents an average of all scores; recognizes that some test materials may lead to effects which persist throughout the length of the test; and acknowledges that animal responses in a test may be quite variable. An additional category for mild skin irritant (Category 3) may be used.
Reversibility of skin lesions is another consideration in evaluating irritant responses. When inflammation persists to the end of the observation period in 2 or more test animals, taking into consideration alopecia (limited area), hyperkeratosis, hyperplasia and scaling, then a material should be considered to be an irritant. Animal irritant responses within a test can be quite variable, as they are with corrosion. A separate irritant criterion accommodates cases when there is a significant irritant response but less than the mean score criterion for a positive test. For example, a test material might be designated as an irritant if at least 1 of 3 tested animals shows a very elevated mean score throughout the study, including lesions persisting at the end of an observation period of normally 14 days. Other responses could also fulfill this criterion. However, it should be ascertained that the responses are the result of chemical exposure. Addition of this criterion increases the sensitivity of the classification system. 5.3.4 5.3.4.1 Classification criteria for mixtures Classification of a mixture as corrosive or irritant
The classification of mixtures according to their ingredients concentration, classification categories and chemical/toxicological properties is shown in Tables 5 and 6. Table 5 Concentration of ingredients of a mixture classified as skin Category 1, 2 or 3 that would trigger classification of the mixture as hazardous to skin (Category 1, 2 or 3) Sum of ingredients classifications a Category 1 Category 2 Category 3 (10 x Category 1) + Category 2 (10 x Category 1) + Category 2 + Category 3 Concentration for mixture classification Skin corrosive Skin irritant Category 1 Category 2 Category 3 c5% c 1% but c < 5% c 10 % c 1% but c < 10% c 10 % c 10 % c 1% but c < 10% c 10 %
For subcategories of Skin Category 1 the sum of all ingredients of a mixture classified as Skin Category 1A, 1B or 1C respectively, should each be 5% in order to classify the mixture as either Skin Category 1A, 1B or 1C. In case the sum of the Skin Category 1A ingredients is < 5% but the sum of Skin Category ingredients 1A+1B is 5%, the mixture should be classified as Skin Category 1B. Similarly, in case the sum of Skin Category 1A + 1B is < 5%, but the sum of Category 1A + 1B + 1C is 5% the mixture would be classified as Category 1C. NOTE c is the sum of ingredients classification. a Categories according to Tables 3 and 4.
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Table 6 Concentration of ingredients of a mixture for which the additivity approach which would trigger the classification of the mixture as hazardous to skin is not applicable Ingredients Acid with pH 2 Base with pH 11.5 Other corrosive (Category 1) ingredients for which additivity does not apply Other irritant (Category 2 and 3) ingredients for which additivity does not apply, including acids and bases 5.3.4.2 Concentration 1% 1% 1% Mixture classification Category 1 Category 1 Category 1
3%
Category 2
Classification of mixtures when data are available
5.3.4.2.1 The mixture will be classified using the criteria for substances, and taking into account the testing and evaluation strategies to develop data for these hazard classes. 5.3.4.2.2 Unlike other hazard classes, there are alternative tests available for skin corrosivity of certain types of chemicals that can give an accurate result for classification purposes, as well as being simple and relatively inexpensive to perform. When considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and irritation to help ensure an accurate classification, as well as avoid unnecessary animal testing. A mixture is considered corrosive (Skin Category 1) if it has a pH of 2 or less or a pH of 11.5 or greater. If consideration of alkali/acid reserve suggests the substance or preparation may not be corrosive despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test.
5.3.4.3 Classification of mixtures when data are not available for the complete mixture: Bridging principles NOTE Where the mixture itself has not been tested to determine its skin irritation/corrosion, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 5.3.4.3.1 Dilution
f a mixture is diluted with a diluent which has an equivalent or lower corrosivity/irritancy classification than the least corrosive/irritant original ingredient and which is not expected to affect the corrosivity/irritancy of other ingredients, then the new mixture may be classified as equivalent to the original mixture. Alternatively, the method explained in 5.3.4.4 could be applied. 5.3.4.3.2 Batching
The irritation/corrosion potential of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the toxicity of the batch has changed. If the latter occurs, new classification is necessary.
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ABNT NBR 14725-2:2009

5.3.4.3.3 Concentration of mixtures of the highest corrosion/ irritation category
If a tested mixture classified in the highest subcategory for corrosion is concentrated, a more concentrated mixture should be classified in the highest corrosion subcategory without additional testing. If a tested mixture classified in the highest category for skin irritation is concentrated and does not contain corrosive ingredients, a more concentrated mixture should be classified in the highest irritation category without additional testing. 5.3.4.3.4 Interpolation within one toxicity category
For three mixtures with identical ingredients, where A and B are in the same irritation/ corrosion toxicity category and mixture C has the same toxicologically active ingredients with concentrations intermediate to the concentrations of those ingredients in mixtures A and B, then mixture C is assumed to be in the same irritation/corrosion category as A and B. 5.3.4.3.5 Substantially similar mixtures
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Classification for A and C for corrosivity / irritability are available and are the same, i.e. they are in the same hazard category and are not expected to affect the carcinogenicity of B.
Then there is no need to test mixture (2) if mixture (1) is already characterized by testing and both mixtures would be classified in the same category.
5.3.4.3.6
Aerosols
An aerosol form of a mixture may be classified in the same hazard category as the tested non-aerosolized form of mixture if the added propellant does not affect the irritation or corrosive properties of the mixture upon spraying. 5.3.4.4 Classification of mixtures when data are available for all components or only for some components of the mixture 5.3.4.4.1 In order to make use of all available data for purposes of classifying the skin irritation/corrosion hazards of mixtures, the following assumption has been made and is applied where appropriate in the tiered approach: The relevant ingredients of a mixture are those which are present in concentrations of 1% (weight/weight for solids, liquids, dusts, mists and vapors and volume/volume for gases) or greater, unless there is a presumption (e.g. in the case of corrosive ingredients) that an ingredient present at a concentration of less than 1% can still be relevant for classifying the mixture for skin irritation/corrosion. . 5.3.4.4.2 In general, the approach to classification of mixtures as irritant or corrosive to skin when data are available on the components, but not on the mixture as a whole, is based on the theory of additivity, such that each corrosive or irritant component contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive components when they are present at a concentration below the concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as an irritant. The mixture is classified as corrosive or irritant when the sum of the concentrations of such components exceeds a cut-off value/concentration limit.
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ABNT NBR 14725-2:2009

5.3.4.4.3 Table 5 below provides the cut-off value/concentration limits to be used to determine if the mixture is considered to be an irritant or a corrosive to the skin. 5.3.4.4.4 Particular care must be taken when classifying certain types of chemicals such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in 5.3.4.4.1 and 5.3.4.4.2 might not work given that many of such substances are corrosive or irritant at concentrations < 1%. For mixtures containing strong acids or bases the pH should be used as classification criteria (see 5.3.4.2.2), since pH will be a better indicator of corrosion than the concentration limits of Table 5. A mixture containing corrosive or irritant ingredients that cannot be classified based on the additivity approach shown in Table 5 due to chemical characteristics that make this approach unworkable, should be classified as Skin Category 1 if it contains 1% of a corrosive ingredient and as Skin Category 2 or 3 when it contains 3% an irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 5 does not apply is summarized in Table 6. 5.3.4.4.5 On occasion, reliable data may show that the skin corrosion/irritation of an ingredient will not be evident when present at a level above the generic concentration cut-off levels mentioned in Tables 5 e 6. In these cases the mixture could be classified according to those information (see 4.9). On occasion, when it is expected that the skin corrosion/irritation of an ingredient will not be evident when present at a level above the generic concentration cut-off levels mentioned in Tables 5 e 6, testing of the mixture may be considered. 5.3.4.4.6 If there are data showing that (an) ingredient(s) may be corrosive or irritant at a concentration of < 1% (corrosive) or < 3% (irritant), the mixture should be classified accordingly (see 4.9). 5.3.5 Decision logic Diagrams
Figures 3 e 4 an be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
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ABNT NBR 14725-2:2009
Substance: Are there data/information to evaluate skin corrosion/irritation?
No
Yes
Mixture: Does the mixture as whole or its ingredients have data/information to evaluate skin corrosion/irritation?
No
Yes
Mixture: Does the mixture as a whole have data/information to evaluate skin corrosion/irritation?
No
See Figure 4
Yes
Is the substance or mixture corrosive considering: Existing human experience showing irreversible damage to skin, Existing animal observations indicating skin corrosion after single or repeated exposure, In vitro data, Information available from structurally related compounds, pH extremes of 2 or 11.53, Destruction of skin in 1 or more test animals?
No
Figure 3 Decision logic for acute toxicity skin irritation or corrosion
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ABNT NBR 14725-2:2009
No
Is the substance or mixture an irritant considering: Existing human experience and data, single or repeated exposure, Existing animal observations including single or repeated exposure, In vitro data, Information available from structurally related compounds, Skin irritation data from an animal study ?
No Category 3 Is the substance or mixture a mild irritant considering criteria in Table 4? No
Yes Warning
Not classified Figura 3 (continuing)
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ABNT NBR 14725-2:2009
Yes
Does the mixture contain 1% of an ingredient 4,5 which is corrosive (see 3.2.1, 3.2.2.2 to 3.2.2.4) and for which the additivity principle may not apply, such as:
Acids and bases with extreme pH 2 or 11.5, or Inorganic salts, or Aldehydes, or Phenols, or Surfactants, or Other ingredients?
No Category 2
Does the mixture contain 3% of an ingredient which is irritant and for which additivity principle may not apply, including acids and bases?
Yes Warning
No
Does the mixture contain one or more corrosive ingredients for which additivity applies and where the sum of concentrations of Ingredient classification
Skin Category 1 5%?
No
Does the mixture contain one or more corrosive or irritant ingredients for which additivity applies and where the sum of concentrations of Ingredient classification Skin Category 1 1% but 5%, or Skin Category 2 10%, or (10 Skin Category 1) + Skin Category 2 10%?
No
Does the mixture contain one or more corrosive or irritant ingredients for which additivity applies, and where the sum of concentrations of Ingredients classification is Skin Category 2 1% but < 10%, or Skin Category 3 10%, or (10 Skin Category 1) + Skin Category 2 1% but < 10%, or (10 Skin Category 1) + Skin Category 2 + Skin Category 3 10%?
No
Not classified
Figure 4 Decision logic for acute toxicity skin irritation or corrosion - Classification of mixtures when data are available for components
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ABNT NBR 14725-2:2009 5.4 Serious eye damage / eye irritation

General considerations
5.4.1 Classification criteria for ingredients 5.4.1.1 Several factors should be considered in determining the serious eye damage or irritation potential of chemicals before testing is undertaken. Accumulated human and animal experience should be the first line of analysis. In some cases, sufficient information may be available on the ingredients of a chemical structure related to the classification of the mixture. Likewise, pH extremes like 2 and 11.5 may produce serious eye damage. Possible skin corrosion has to be evaluated prior to consideration of serious eye damage/eye irritation in order to avoid testing for local effects on eyes with skin corrosive substances. In vitro alternatives that have been validated and accepted may be used to make classification decisions. The classification criteria for substances and mixtures causing eye damage and eye irritation are shown in Table 7. Table 7 Testing and evaluation strategy for serious eye damage and eye irritation for chemicals classification
Step 1a Parameter Data relating to historical human or animal experience No or unknown Data relating to historical human or animal experience No or unknown Data relating to historical human or animal experience No or unknown Structure activity relationships / Structure property relationships (SAR/SPR) No or unknown Structure activity relationships / Structure property relationships (SAR/SPR) No or unknown Structure activity relationships / Structure property relationships (SAR/SPR) No or unknown Findings Serious eye damage Eye irritant Skin corrosive Skin irritant Severe damage to eyes Eye irritant Conclusions Category 1 Category 2 Category 1 No evaluation of effects on eyes; deemed to be Category 2 Category 1 No evaluation of effects on eyes; deemed to be Category 2 No evaluation of effects on eyes; deemed to be Category 1
1b
1c
2a
2b
2c
Skin corrosive
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Table 7 (continuing)
Step 3a 3b 4 Parameter pH/acid or alkaline reserve 2 < pH < 11.5 (no buffering potential) Other information indicating the material is a skin corrosive No Is a valid in vitro test available to assess severe damage to eyes In vitro test for severe eye irritation Not a severe eye irritant Is there a valid in vitro test for eye irritation available? No Yes In vitro eye irritation test? No indication of eye irritant properties Experimentally assess skin corrosion potential 4 Not corrosive Eye test in 1 rabbit No severe eye damage 4 Eye test in more than 1 or 2 rabbits Findings pH 11.5 or pH 2 (considering acid or alkaline) Yes Conclusions Category 1 No evaluation of effects on eyes; deemed to be Category 1
5 5a
No Severe damage to eyes
Go to step 6 Category 1
No, but an in vitro test for severe eye irritancy was negative In the absence of any in vitro test Eye irritant Skin corrosive Severe damage to eyes Eye irritant Not an eye irritant
Go to step 8 Go to step 7 Category 2 No evaluation of effects on eyes; deemed to be Category 1 Category 1 Category 2 Not classified
6a
8 9
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5.4.1.2 Eye irritant Category 1 - Irreversible effects on the eye
An eye irritant Category 1 (irreversible effects on the eye) is a test material that produces: a) b) at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or at least in 2 of 3 tested animals, a positive response of 1) corneal opacity 3 and/or 2) iritis > 1.5 calculated as the mean scores following grading at 24, 48 and 72 hours after application of the test material. 5.4.1.3 Eye irritant Category 2A and 2B - Reversible effects on the eye
An eye irritant Category 2A (eye irritant) is a test material that produces at least in two or three animals, a positive response to: a) b) c) d) corneal opacity 1; and/or iris irritation (irite) 1; and/or conjunctival redness 2, and/or conjunctival oedema (chemosis) 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of normally 21 days. Within this category, an eye irritant is considered mildly irritating to eyes (Category 2B) when the effects listed above are fully reversible within 7 days of observation.
5.4.2 5.4.2.1
Classification criteria for mixtures Classification of mixtures when data are available for the complete mixture
5.4.2.1.1 The mixture will be classified using the criteria for substances, and taking into account the testing and evaluation strategies used to develop data for these hazard classes. 5.4.2.1.2 Unlike other hazard classes, there are alternative tests available for skin corrosivity of certain types of chemicals that can give an accurate result for classification purposes, as well as being simple and relatively inexpensive to perform. When considering testing of the mixture manufacturers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and serious eye damage and eye irritation to help ensure an accurate classification, as well as avoid unnecessary animal testing. 5.4.2.1.3 A mixture is considered to cause serious eye damage (Eye Category 1) if it has a pH of 2 or less or 11.5 or greater. If consideration of alkali/acid reserve suggests the substance or preparation may not have the potential to cause serious eye damage despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test.
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5.4.2.2 Classification of mixtures when data are not available for the complete mixture: Bridging principles NOTE Where the mixture itself has not been tested to determine its skin corrosivity or potential to cause serious eye damage or irritation, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 5.4.2.2.1 Dilution
If a mixture is diluted with a diluent that has an equivalent or lower classification for serious eye damage/irritancy classification than the least damaging/irritant original ingredient and which is not expected to affect the corrosivity/irritancy of other ingredients, then the new mixture may be classified as equivalent to the original mixture. Alternatively, the method explained in 5.4.2.3 could be applied. 5.4.2.2.2 Batching
The irritation/serious eye damage potential of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the toxicity of the batch has changed. If the latter occurs, new classification is necessary 5.4.2.2.3 Concentration of mixtures of the highest serious eye damage/ irritation category
If a tested mixture classified in the highest category for serious eye damage is concentrated, a more concentrated mixture should be classified in the highest serious eye damage category without additional testing. If a tested mixture classified in the highest subcategory for skin/eye irritation is concentrated and does not contain serious eye damage ingredients, a more concentrated mixture should be classified in the highest irritation category without additional testing. 5.4.2.2.4 Interpolation within one toxicity category
For three mixtures with identical ingredients, where A and B are in the same irritation/ serious eye damage toxicity category and mixture C has the same toxicologically active ingredients with concentrations intermediate to the concentrations of those ingredients in mixtures A and B, then mixture C is assumed to be in the same irritation/serious eye damage category as A and B. 5.4.2.2.5 Substantially similar mixtures
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Classification for A and C for eye irritation or eye lesion are available and are the same.
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ABNT NBR 14725-2:2009

5.4.2.2.6 Aerosols
An aerosol form of a mixture may be classified in the same hazard category as the tested non-aerosolized form of mixture provided that the added propellant does not affect the irritation or corrosive properties of the mixture upon spraying. Bridging principles apply for the intrinsic hazard classification of aerosols, however, the need to evaluate the potential for mechanical eye damage from the physical force of the spray is recognized. 5.4.2.3 Classification of mixtures when data are available for all components or only for some components of the mixture 5.4.2.3.1 In order to make use of all available data for purposes of classifying the eye irritation/serious eye damaging properties of the mixtures, the following assumption has been made and is applied where appropriate in the tiered approach, the relevant ingredients of a mixture are those which are present in concentrations of 1% (w/w for solids, liquids, dusts, mists and vapors and v/v for gases) or greater, unless there is a presumption (e.g. in the case of corrosive ingredients) that an ingredient present at a concentration of less than 1% can still be relevant for classifying the mixture for eye irritation/serious eye damage. 5.4.2.3.2 In general, the approach to classification of mixtures as eye irritant or seriously damaging to the eye when data are available on the components, but not on the mixture as a whole, is based on the theory of additivity, such that each corrosive or irritant component contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive components when they are present at a concentration below the concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as an irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such components exceeds a threshold cut-off value/concentration limit. 5.4.2.3.3 Table 8 provides the cut-off value/concentration limits to be used to determine if the mixture should be classified an irritant or a seriously damaging to the eye. Table 8 Concentration of ingredients of a mixture classified as skin Category 1 and/or eye Category 1 or 2 that would trigger classification of the mixtures as hazardous to the eye (Category 1 or 2)
Sum of ingredients classifications Eye or Skin Category 1 Eye Category 2/2A 10 Eye Category 1) + Eye Category 2/2A Skin Category 1 + Eye Category 1 10 (Skin Category 1 + Eye Category 1) + Eye Category 2A/2B NOTE c is the sum of ingredients concentrations.
Concentration classification of the mixture Irreversible eye Reversible eye effects effects Category 1 Category 2 c3% 1%c<3% c 10 % c 10 % c3% 1%c<3% c 10 %
5.4.2.3.4 Particular care must be taken when classifying certain types of chemicals such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in 5.4.2.3.1 and 5.4.2.3.2 might not work given that many of such substances are corrosive or irritant at concentrations < 1%. For mixtures containing strong acids or bases the pH should be used as classification criteria (see 5.4.2.1.3), since pH will be a better indicator of severe eye damage than the concentration limits of Table 8. A mixture containing corrosive or irritant ingredients that cannot be classified based on the additivity approach shown in Table 8, due to chemical characteristics that make this approach unworkable, should be classified as eye Category 1 if it contains 1% of a corrosive ingredient and as eye Category 2 when it contains 3% an irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 8 does not apply is summarized in Table 9.
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ABNT NBR 14725-2:2009

Table 9 Concentration of ingredients of a mixture for which the additivity approach does not apply, that would trigger classification of the mixture as hazardous to the eye Ingredient Acid with pH < 2 Base with pH > 11.5 Other corrosive (Category 1) ingredients for which additivity does not apply Other irritant (Category 2) ingredients for which additivity does not apply, including acids and bases Concentration 1% 1% 1% 3% Mixture classification Category 1 Category 1 Category 1 Category 2
5.4.2.3.5 On occasion, reliable data may show that the reversible/irreversible eye effects of an ingredient will not be evident when present at a level above the generic cut-off values / concentration limits mentioned in Tables 8 and 9. In these cases, the mixture could be classified according to those data (see 4.9). On occasion, when it is expected that the skin corrosion/irritation or the reversible/irreversible eye effects of an ingredient will not be evident when present at a level above the generic concentration/cut-off levels mentioned in Tables 8 and 9, testing of the mixture may be considered. In those cases, the tiered weight of evidence strategy should be applied as referred to in section 5.4.1 and in Table 7. 5.4.2.3.6 If there are data showing that (an) ingredient(s) may be corrosive or irritant at a concentration of < 1% (corrosive) or < 3% (irritant), the mixture should be classified accordingly (see also 4.9). The percentages of ingredients in mixture classifying the mixture in categories 1 and 2 are shown in Tables 8 and 9. 5.4.3 Decision logic Diagrams
Figures 5 and 6, can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
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ABNT NBR 14725-2:2009

Substance: Are there data/information to evaluate serious eye damage/eye irritation?
No
Yes
Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate serious eye damage/eye irritation?
No
Yes
Mixture: Does the mixture as a whole have data/information to evaluate serious eye damage/eye irritation?
No
See Figure 6
Yes
Does the substance or mixture have potential to cause irreversible eye damage considering: Existing human experience, Existing animal observations including single or repeated exposure, In vitro data, Information available from structurally related compounds, pH extremes of 2 or 11.5,
Irreversible eye damage in 1 or more test animals? (see 5.4.1.1) ?
No
Is the substance or mixture an eye irritant considering: Existing human experience and data, single or repeated exposure Existing animal observations including single or repeated exposure, In vitro data, Information available from structurally related compounds,
Category 2A Yes Warning
Eye irritation data from an animal study?
No
Is the substance or mixture a mild irritant Category 2B?
Category 2B Yes Warning
No
Not classified
Figure 5 Decision logic for serious eye damage and eye irritation
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Yes
Does the mixture contain 1 % of an ingredient which causes irreversible eye damage and for which additivity principle may not apply, such as: Acids and bases with extreme pH's 2 or 11,5, or Inorganic salts, or Aldehydes, or Phenols, or Surfactants, or Other ingredients? Yes
Category 1
Danger
No
Category 2 Does the mixture contain 3% of an ingredient which is irritant and for which additivity principle may not apply, including acids and bases? No Yes Warning
Does the mixture contain one or more corrosive or irritant ingredients for which additivity applies, and where the sum of concentrations of ingredients classified as7: Eye or Skin Category 1 3% or Skin category 1 + eye category 1 3%? No
Category1 Yes Danger
Does the mixture contain one or more corrosive or irritant ingredients for which additivity applies, and where the sum of concentrations of Ingredient classification Eye or Skin Category 1 1% but < 3%, or Eye Category 2/2A 10%, or (10 x Eye Category 1) + Eye Category 2A/2B 10%, or Skin Category 1 + Eye Category 1 1% but < 3%, or 10 x (Skin Category 1 + Eye Category 1) + Eye Category 2A/2B 10%? ? No Not classified
Category 2A
Yes Warning
Figure 6 Decision logic for serious eye damage and eye irritations / Classification of mixtures based on information /data of ingredients
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ABNT NBR 14725-2:2009 5.5 Respiratory or skin sensitization
5.5.1 Classification criteria for substances If there is evidence in humans that the substance can induce respiratory sensitization or if there are positive results from animal tests, these substances shall be classified as respiratory sensitizers (Category 1). Evidence in humans means that the substance can induce specific respiratory hypersensitivity such as asthma, rhinitis, conjunctivitis and alveolitis. The symptom will have the clinical character of an allergic reaction (see GHS Book, subsection 3.4.2). 5.5.2 5.5.2.1 Classification criteria for mixtures Classification of mixtures when data are available for the complete mixture
When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture can be classified by weight of evidence evaluation of these data. 5.5.2.2 Classification of mixtures when data are not available for the complete mixture: Bridging Principles NOTE Where the mixture itself has not been tested to determine its sensitizing properties, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 5.5.2.2.1 Dilution
If a mixture is diluted with a diluent which is not a sensitizer and which is not expected to affect the sensitization of other ingredients, then the new mixture may be classified as equivalent to the original mixture. 5.5.2.2.2 Batching
The sensitizing properties of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the sensitization of the batch has changed. If the latter occurs, new classification is necessary. 5.5.2.2.3 Substantially similar mixtures
Given the following: a) Two mixtures: 1) 2) b) c) d) e) A + B; C + B;
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Ingredient B is a sensitizer and ingredients A and C are not sensitizers; A and C are not expected to affect the sensitizing properties of B.
If mixture (1) is already classified by testing, then mixture (2i) can be assigned the same hazard category.
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5.5.2.2.4 Aerosols
An aerosol form of the mixture may be classified in the same hazard category as the tested non-aerosolized form of the mixture provided that the added propellant does not affect the sensitizing properties of the mixture upon spraying (pulverized, sprinkled over) 5.5.2.3 Classification of mixtures when data are available for all components or only for some components of the mixture The mixture should be classified as a respiratory or skin sensitizer when at least one ingredient has been classified as a respiratory or skin sensitizer and is present at or above the appropriate cutoff value/concentration limit for the specific endpoint as shown in Table 10. Table 10 Cut-off values/concentration limits of ingredients of a mixture classified as either skin sensitizers or respiratory sensitizers that would trigger classification of the mixture Cut-off values/concentration limits used for classify the mixture as Category 1 Skin sensitizer Respiratory sensitizer All physical states Solid/Liquid Gas 0,1 % 0,1 % 0,1 %
Ingredient Classified as: Skin sensitizer Respiratory sensitizer 5.5.3 Decision logic Diagram
Figures 7 and 8 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logics.
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Substance: Does the substance have respiratory sensitization data? Mixture: Does the mixture as a whole or its ingredients have respiratory sensitization data? Classification not possible
No
Yes
No Classification not possible
Yes Mixture: Does the mixture as a whole have respiratory sensitization data? Yes
No
Is there evidence in humans that the substance/mixture can induce specific respiratory hypersensitivity, and/or are there positive results from an appropriate animal test?
No Not classified Can bridging principles be applied? No Classify in appropriate category
Yes
Does the mixture contain one or more ingredients classified as a respiratory sensitizer ?
Category 1 Yes
Danger No Not classified
Figure 7 Decision logic classification for respiratory sensitization
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Substance: Does the substance have skin sensitization data? Mixture: Does the mixture as a whole or its ingredients have skin sensitization data? Classification not possible
No
Yes
No
Yes Mixture: Does the mixture as a whole have skin sensitization data? Yes
No
Is there evidence in humans that the substance/mixture can induce sensitization by skin contact in a substantial number of persons, or are there positive results from an appropriate animal test?
No Not classified Classify in appropriate category
Yes
Does the mixture contain one or more ingredients classified as a skin sensitizer?
Category 1 Yes
Warning No Not classified
Figure 8 Decision logic for classification of skin sensitization
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ABNT NBR 14725-2:2009 5.6 Germ cell mutagenicity
5.6.1 Classification criteria Table 11 has the criteria for classification of substances and mixtures related to their mutagenic potential. Table 12 has the criteria for classification of mixtures according to the concentration of the ingredients in the mixture. Table 11 Hazard categories for germ cell mutagens Category Chemicals known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans Chemicals known to induce heritable mutations in germ cells of humans Critrios Positive evidence from human epidemiological studies. Positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or
Positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells. This supporting evidence may, for example, be derived from mutagenicity/genotoxic tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or Positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.
1 1A
1B
Chemicals which should be regarded as inducing heritable mutations in the germ cells of humans
2a
Chemicals which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans
Positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from: Somatic cell mutagenicity tests in vivo, in mammals; or Other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Chemicals which are positive in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, should be considered for classification as Category 2 mutagens.
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Table 12 The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units) Cut-off/concentration limits Category 1 Category 2 mutagen mutagen Category 1 mutagen 0.1 % Category 2 mutagen 0.1 % NOTE The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units). 5.6.2 5.6.2.1 Classification criteria for mixtures Classification of mixtures when data are available for the complete mixture Ingredient classified as:
Classification of mixtures will be based on the available test data for the individual ingredients of the mixture using cut-off values/concentration limits for the ingredients classified as germ cell mutagens. The classification may be modified on a case-by-case basis based on the available test data for the mixture as a whole. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of germ cell mutagenicity test systems. Adequate documentation supporting the classification should be retained and made available for review upon request. 5.6.2.2 Classification of mixtures when data are not available for the complete mixture: Bridging principles NOTE Where the mixture itself has not been tested to determine its germ cell mutagenicity hazard, but there are sufficient data on the individual ingredients and similar tested mixtures to characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 5.6.2.2.1 Dilution
If a mixture is diluted with a diluent which is not expected to affect the germ cell mutagenicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture. 5.6.2.2.2 Batching
The germ cell mutagenic potential of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product produced by and under the control of the same manufacturer unless there is reason to believe there is significant variation in composition such that the germ cell mutagenic potential of the batch has changed. If the latter occurs, a new classification is necessary. 5.6.2.2.3 Substantially similar mixtures
Given the following: a) Two mixtures: 1) 2) A + B; C + B;
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b) c) d) The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the mutagenicity of B.
Then there is no need to test mixture (2) if mixture (1) is already characterized by testing and both mixtures would be classified in the same category. 5.6.2.3 Classification of mixtures when data are available for all components or only for some components of the mixture The mixture will be classified as a mutagen when at least one ingredient has been classified as a Category 1 or Category 2 mutagen and is present at or above the appropriate cut-off value/concentration limit as shown in Table 3.5.1 below for Category 1 and 2 respectively. 5.6.3 Decision logic Diagrams
Figures 9 and 10 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logics.
Substance: Does the substance have data on mutagenicity? Yes
No
According to the criteria, is the substance: Known to induce heritable mutations in germ cells of humans, or Should it be regarded as if it induces heritable mutations in the germ cells of humans? Application of the criteria needs expert judgment in a weight of evidence approach.
No
According to the criteria, does the substance cause concern for humans owing to the possibility that it may induce heritable mutations in the germ cells of humans? Application of the criteria needs expert judgment in a weight of evidence approach. .
No
Not classified
Figure 9 Decision logic for classification of mutagenic substances in germ cells
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Classification modified on a case-by-case basis
Are test data available for the complete mixture?
Yes
No
Are the test results on the mixture conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of germ cell mutagenicity test systems?
Yes
No
Danger or Warning or No classification
Yes
Classification based on individual ingredients of the mixture . Mixture: Classification of mixtures will be based on the available test data for the individual ingredients of the mixture, using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by-case basis based on the available test data for the mixture as a whole or based on bridging principles. See Modified classification on a case-by-case basis.
Classification based on the mixture ingredients

Does the mixture contain one or more ingredients classified as a Category 1 mutagen at concentration 0.1%? No Yes
Category 1
Danger
Does the mixture contain one or more ingredients classified as a Category 2 mutagen at concentration 1.0 %? No
Category 2 Yes
Danger
Not classified
Figure 10 Decision logic for classification of germ cell mutagenicity on mixtures
36
ABNT NBR 14725-2:2009 5.7 Carcinogenicity
5.7.1 Classification criteria Carcinogen substances and mixtures should be classified according to the criteria and elements set forth in Tables 13 and 14. Table 13 Hazard categories for carcinogens Category 1 1A Known or presumed human carcinogens Known to have carcinogenic potential for humans; the placing of a chemical is largely based on human evidence. Criteria a The placing of a chemical in Category 1 is done based on epidemiological and/or animal data. Based on strength of evidence together with additional considerations, such evidence may be derived from human studies that establish a causal relationship between human exposure to a chemical and the development of cancer (known human carcinogen). Alternatively, evidence may be derived from animal experiments for which there is sufficient evidence to demonstrate animal carcinogenicity (presumed human carcinogen). In addition, on a case by case basis, scientific judgment may warrant a decision of presumed human carcinogenicity derived from studies showing limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals. Classification: Category 1 (A and B) Carcinogen The placing of a chemical in Category 2 is done based on evidence obtained from human and/or animal studies not sufficiently convincing to place the chemical in Category 1. Classification: Category 2 carcinogen
a
1B
Presumed to have carcinogenic potential for humans; the placing of a chemical is largely based on animal evidence.
Suspected human carcinogens
See GHS book, subsection 3.6.2.
Table 14 Cut-off values/concentration limits of ingredients of a mixture classified as carcinogen that would trigger classification of the mixture Ingredient classification Cut-off/concentration limits which trigger mixture classification Category 1 Category 2 carcinogen carcinogen 0,1 % 0,1 %
Category 1 carcinogen Category 2 carcinogen
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5.7.2 5.7.2.1 Classification criteria for mixtures Classification of mixtures when data are available for the complete mixture
Classification of mixtures will be based on the available test data of the individual ingredients of the mixture using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by case basis based on the available test data for the mixture as a whole. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of carcinogenicity test systems. 5.7.2.2 Classification of mixtures when data are not available for the complete mixture: Bridging Principles NOTE Where the mixture itself has not been tested to determine its carcinogenic hazard, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 5.7.2.2.1 Dilution
If a mixture is diluted with a diluent that is not expected to affect the carcinogenicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture. 5.7.2.2.2 Batching
The carcinogenic potential of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product produced by and under the control of the same manufacturer unless there is reason to believe there is significant variation in composition such that the carcinogenic potential of the batch has changed. If the latter occurs, a new classification is necessary.
5.7.2.2.3
Substantially similar mixtures
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the carcinogenicity of B.
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5.7.2.3 Classification of mixtures when data are available for all components or only for some components of the mixture The mixture will be classified as a carcinogen when at least one ingredient has been classified as a Category 1 or Category 2 carcinogen and is present at or above the appropriate cut-off value/concentration limit as shown in Table 14, for Category 1 and 2 respectively. 5.7.3 Decision logic Diagrams
Figures 11 e 12 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logics.
Substance: Does the substance have carcinogenicity data? Yes
No
According to the criteria, is the substance: Known to have carcinogenic potential for humans, or Presumed to have carcinogenic potential for humans? Yes
Category 1
Application of the criteria needs expert judgment in a strength and weight of evidence approach.
Danger
No
According to the criteria, is the substance a suspected human carcinogen? Application of the criteria needs expert judgment in a strength and weight of evidence approach. Yes
Category 2
Warning No
Not classified
Figure 11 Decision logic for classification of germ cell mutagenicity on substances
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Are test data available for the complete mixture?
Yes
Are the test results on the mixture conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of carcinogenicity test systems?
Yes
No No Danger or Warning or No classification Yes
Can bridging principles be applied?
No Classification based on individual ingredients of the mixture.
Mixtures Classification of mixtures will be based on the available test data for the individual ingredients of the mixture, using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by-case basis based on the available test data for the mixture as a whole or based on bridging principles.
Classification based on individual ingredients of the mixture Does the mixture contain one or more ingredients classified as a Category 1 carcinogen at: 0.1 %? Yes
Category 1
No
Danger
Does the mixture contain one or more ingredients classified as a Category 2 carcinogen at 0.1 %?
Category 2 Yes
Warning No
Not classified
Figure 12 Decision logic for classification of carcinogen mixtures
40
ABNT NBR 14725-2:2009 5.8 Toxicity to reproduction and lactation

5.8.1 Classification criteria - Effects on reproductivity Table 15 establishes classification criteria for substances and toxic mixtures to reproduction. Table15 Hazard categories for reproductive toxicants Category Criteria a This category includes substances which are known to have produced an adverse effect on sexual function and fertility or on development in humans or for which there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans. For regulatory purposes, a substance can be further distinguished on the basis of whether the evidence for classification is primarily from human data (Category 1A) or from animal data (Category 1B). The placing of the substance in this category is largely based on evidence from humans. The placing of the substance in this category is largely based on evidence from experimental animals. Data from animal studies should provide clear evidence of an adverse effect on sexual function and fertility or on development in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of other toxic effects. However, when there is mechanistic information that raises doubt about the relevance of the effect for humans, classification in Category 2 may be more appropriate. This category includes substances for which there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, in the absence of other toxic effects. If occurring together with other toxic effects, the adverse effect on reproduction is not considered a secondary non-specific consequence of others toxic effects when such evidence is not sufficiently convincing to place the substance in Category 1. For instance, deficiencies in the study may turn the quality of evidence less convincing; considering this, Category 2 could be a more appropriate classification.
Known or presumed known human reproductive or development toxicant
1A
Known human reproductive or development toxicant
1B
Presumed human reproductive or development toxicant
Suspect human reproductive or development toxicant
See GHS book, subsection 3.7.2.
5.8.2 Classification categories - Effects on or via lactation Effects on or via lactation are allocated to a separate single category. It is appreciated that for many substances there is no information on the potential to cause adverse effects on the offspring via lactation. However, substances which are absorbed by women and have been shown to interfere with lactation, or which may be present (including metabolites) in breast milk in amounts sufficient to cause concern for the health of a breastfed child, should be classified to indicate this property hazardous to breastfed babies. This classification can be assigned on the basis of: studies of absorption, metabolism, distribution and excretion indicating the likelihood of the substance to be present in potentially toxic levels in breast milk; and/or results of one or two generation studies in animals providing clear evidence of adverse effect in the offspring due to transfer in the milk or adverse effect on the quality of the milk; and/or human evidence indicating a hazard to babies during the lactation period.
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5.8.3 Classification criteria for mixtures 5.8.3.1 Classification of mixtures when data are available for the complete mixture Classification of mixtures will be based on the available test data of the individual constituents of the mixture using cut-off values/concentration limits for the components of the mixture. The classification may be modified on a caseby case basis based on the available test data for the mixture as a whole. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of reproduction test systems. Adequate documentation supporting the classification should be retained and made available for review upon request. 5.8.3.2 Classification of mixtures when data are not available for the complete mixture: Bridging Principles NOTE Where the mixture itself has not been tested to determine its reproductive toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 5.8.3.2.1 Dilution
If a mixture is diluted with a diluent which is not expected to affect the reproductive toxicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture. 5.8.3.2.2 Batching
The reproductive toxicity potential of one production batch of a complex mixture can be assumed to be substantially equivalent to that of another production batch of the same commercial product produced by and under the control of the same manufacturer unless there is reason to believe there is significant variation in composition such that the reproductive toxicity potential of the batch has changed. If the latter occurs, a new classification is necessary.
5.8.3.2.3
Substantially similar mixtures
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the toxicity to reproduction of B.
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5.8.3.3 Classification of mixtures when data are available for all components or only for some components of the mixture The mixture will be classified as a reproductive toxicant when at least one ingredient has been classified as a Category 1 or Category 2 reproductive toxicant and is present at or above the appropriate cut-off value/concentration limit as shown in Table 16 for Category 1 and 2, respectively. Table 16 Cut-off values/concentration limits of ingredients of a mixture classified as toxicant to reproduction which trigger the classification Cut-off/concentration limits Category 1 Category 2 Additional reproductive reproductive category for toxicant toxicant effects on or via lactation 0,1 % 0,1 % 0,1 %
Ingredient classification Category 1 reproductive toxicant Category 2 reproductive toxicant Additional category for effects on or via lactation
5.8.4 Decision logic Diagrams Figures 13, 14, and 15 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
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Substance: Does the substance have data on reproductive toxicity? Yes
No
According to the criteria, is the substance: Category 1 a known toxicant to reproduction or development of human beings; or a presumed toxicant to aptitude, reproduction capability, or development of human beings? Application of the criteria needs expert judgment in a weight of evidence approach. No Yes Danger
According to criteria is the substance a suspect toxicant to produce adverse effects on sexual function, fertility, or development of human beings? Application of the criteria needs expert judgment in a weight of evidence approach.
No Not classified
Figure 13 Decision logic for classification of substances and mixtures as to their toxic effect on reproduction
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Are test data available for the complete mixture? Are the test results on the mixture conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of reproduction test systems?
Yes
Yes
No No Danger or Warning or No classification Yes
No Classification based on individual ingredients of the mixture
Classification based on individual ingredients of the mixture

Does the mixture contain one or more ingredients classified as a Category 1 reproductive toxicant at a concentration 0,1 %? Category 1 Yes
No
Danger
Does the mixture contain one or more ingredients classified as a Category 2 reproductive toxicant at a concentration 1.0 %? No
Category 2 Yes
Warning
Not classified
Figure 14 Decision logic for mixtures
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Does the substance according to the criteria cause concern for the health of breastfed? children ? No Additional category for effects on or via lactation
Yes
Not classified
Classification based on individual ingredients of the mixture

Does the mixture contain one or more ingredients classified as Category 1 for effects on or via lactation at a concentration 0,1 %? No Not classified Yes Additional category for effects on or via lactation
Modified classification on a case-by-case basis

Are test data available for the complete mixture? Are the test results on the mixture conclusive taking into account dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of reproduction test systems?
Yes
Yes
Additional category for effects on or via lactation or
No No
No classification
Yes
No Classification based on individual ingredients of the mixture.
Figure 15 Decision logic for classification of substances and mixtures of effects on or via lactation
46
ABNT NBR 14725-2:2009 5.9 Specific target organ systemic toxicity single exposure
5.9.1 Classification categories

Substances should be classified according to Table 17 criteria. Table 17 Categories for specific target organ systemic toxicity - single exposure Categoria Substances that have produced significant toxicity in humans, or that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to produce significant toxicity in humans following single exposure Substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following single exposure Critrios Placing a substance in Category 1 is done on the basis of: reliable and good quality evidence from human cases or epidemiological studies; or. observations from appropriate studies in experimental animals in which significant and/or severe toxic effects of relevance to human health were produced at generally low exposure concentrations. Guidance dose/concentration values are provided below to be used as part of weight-of-evidence evaluation.
Placing a substance in Category 2 is done on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. Guidance dose/concentration values are provided below in order to help in classification. In exceptional cases, human evidence can also be used to place a substance in Category 2. There are target organ effects for which a substance/mixture may not meet the criteria to be classified in Categories 1 or 2 indicated above. These are effects which adversely alter human function for a short duration after exposure. This category only includes narcotic effects and respiratory tract irritation.
For these categories, the specific target organ/system that has been primarily affected by the classified substance may be identified, or the substance may be identified as a general systemic toxicant. Attempts should be made to determine the primary target organ of toxicity and classify for that purpose, e.g. hepatoxicants, neurotoxicants. One should carefully evaluate the data and, where possible, not include secondary effects, e.g. a hepatotoxicant can produce secondary effects in the nervous or gastro-intestinal systems. NOTE In exceptional cases, evidence in human beings may also being used to include a substance in Category 2.
Table 18 shows results from experimental test using animals that are reference values to subsidize the classification on categories 1 and 2. Table 18 Guidance value ranges for single-dose exposures Exposure route Oral (rat) mg/kg bodyweight Dermal (rat or rabbit) mg/kg peso corpreo Inhalation (rat) gas L/L (ppm) Inhalation (rat) vapor mg/L Inhalation (rat) dust/mist/fume mg/L/4 h
a
Guidance value ranges a Category 1 c 300 c 1 000 c 2 500 c 10 c 1.0 Category 2 2 000 c > 300 2 000 c > 1 000 5 000 c > 2 500 20 > c > 10 5.0 c > 1.0 Guidance values do not apply Category 3
See GHS book sub-section 3.8.2. NOTE c is dosage or concentration.
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5.9.2 5.9.2.1 Classification criteria for mixtures Classification of mixtures when data are available for the complete mixture
When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture can be classified by weight of evidence evaluation of this data. Care should be exercised in evaluating data on mixtures, that the dose, duration, observation or analysis, do not render the results inconclusive. 5.9.2.2 Classification of mixtures when data are not available for the complete mixture: Bridging principles NOTE Where the mixture itself has not been tested to determine its specific target organ/systemic toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data can be used in accordance with the following bridging principles. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity of additional testing in animals. 5.9.2.2.1 Dilution
If a mixture is diluted with a substance that has an equivalent or lower toxicity classification than the least toxic original ingredient, and which is not expected to affect the toxicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture. 5.9.2.2.2 Batching
The toxicity of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product, and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the toxicity of the batch has changed. If the latter occurs, new classification is necessary. 5.9.2.2.3 Concentration of highly toxic mixtures
If a mixture is classified in Category 1, and the concentration of the ingredients of the mixture that are in Category 1 is increased, the new mixture should be classified in Category 1 without additional testing. 5.9.2.2.4 Interpolation within one toxicity category
If mixtures A and B are in the same classification category and mixture C is made in which the toxicologically active components have concentrations intermediate to those in mixtures A and B, then mixture C is assumed to be in the same category as A and B. 5.9.2.2.5 Substantially similar mixtures
Given the following: a) Two mixtures: 1) 2) b) c) A + B; C + B;
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2);
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d) Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the toxicity of B.
Then there is no need to test mixture (2) if mixture (1) is already characterized by testing and both mixtures would be classified in the same danger category. 5.9.2.2.6 Aerosols
An aerosol form of a mixture may be classified in the same hazard category as the tested, non-aerosolized form of the mixture for oral and dermal toxicity provided the added propellant does not affect the toxicity of the mixture on spraying. Classification of aerosolized mixtures for inhalation toxicity should be considered separately. 5.9.2.3 Classification of mixtures when data are available for all components or only for some components of the mixture Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture will be classified as a specific target organ/systemic toxicant (specific organ specified), following single exposure, repeated exposure, or both when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ/systemic toxicant and is present at or above the appropriate cut-off value/concentration limit as mentioned in Table 19 for Category 1 and 2 respectively. Table 19 Cut-off values/concentration limits of ingredients of a mixture classified as toxicant to reproduction which trigger the classification Ingredient classification Category 1 Specific target organ toxicant Category 2 Specific target organ toxicant Cut-off/concentration limits Category 1 Category 2 1,0 % 1,0 %
5.9.3
Decision logic Diagrams
Figures 16 e 17 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
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Substance: Does the substance have data and/or information to evaluate specific target organ systemic toxicity following single exposure?
No
Yes
Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate specific target organ systemic toxicity following single exposure?
No
Yes
Mixture: Does the mixture as a whole have data/information to evaluate specific target organ systemic toxicity following single exposure?
No
See Figure 17
Yes Category 1
Following single exposure: Can the substance or mixture produce significant toxicity in humans, or Can it be presumed to have the potential to produce significant toxicity in humans on the basis of evidence from studies in experimental animals? See Table 19 for criteria and guidance values. Application of the criteria needs expert judgment in a weight of evidence approach.
Yes Danger
No Category 2
Following single exposure, can the substance or mixture, be presumed to have the potential to be harmful to human health on the basis of evidence from studies in experimental animals? See Table 19 for criteria and guidance values. Application of the criteria needs expert judgment in a weight of evidence approach.
Yes Warning
No
Following single exposure, can the substance or mixture produce narcotic effects or respiratory tract irritation? See Table 19 for criteria. Application of the criteria needs expert judgment in a weight of evidence approach.
No
Figure 16 Decision logic for classification of target organ systemic toxicity from single exposure
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Yes
Does the mixture contain one or more ingredients classified as a Category 1 specific target organ systemic toxicant at a concentration 1,0 %? See Table 19 for explanation of cut-off values/concentration limits.
Category 1
Yes Danger
No
Does the mixture contain one or more ingredients classified as a Category 2 specific target organ systemic toxicant at a concentration 1,0 %? See Table 19 for explanation of cut-off values/concentration limits.
No
Not classified
Figure 17 Decision logic for classification of target organ systemic toxicity from single exposure Classification of mixtures based on ingredients information
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ABNT NBR 14725-2:2009 5.10 Specific target organ systemic toxicity repeated exposure
5.10.1 Classification criteria Substances and mixtures should be classified according to Table 20 criteria. Table 20 Categories for specific target organ systemic toxicity - repeated exposure Categoria a Critrios Placing a substance in category1 is based on: reliable and good quality evidence from human cases or epidemiological studies; or observations from appropriate studies in experimental animals in which significant and/or severe toxic effects of relevance to human health were produced at generally low exposure concentrations. Guidance dose/concentration values are provided below (see Table 21) to be used as part of weightof-evidence evaluation. Placing a substance in Category 2 is done on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. Guidance dose/concentration values are provided below (see Table 22) in order to help in classification. In exceptional cases human evidence can also be used to place a substance in Category 2.
Substances that have produced significant toxicity in humans, or that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to produce significant toxicity in humans following repeated exposure
Substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following repeated exposure
For both categories the specific target organ/system that has been primarily affected by the classified substance may be identified, or the substance may be identified as a general systemic toxicant. Attempts should be made to determine the primary target organ of toxicity and classify for that purpose, e.g. hepatoxicants, neurotoxicants. One should carefully evaluate the data and, where possible, not include secondary effects, e.g. a hepatotoxicant can produce secondary effects in the nervous or gastrointestinal systems. See GHS book, subsection 3.9.2.
Tables 21 and 22 show guidance values to facilitate the classification of a substance or mixture on categories 1 or 2.
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Table 21 Guidance values to assist in Category 1 classification Route of exposure Oral (rats) mg/kg bodyweight/day Dermal (rat or rabbit) mg/kg bodyweight/day Inhalation (rat) gas L/L (ppm)/6 h/day Inhalation (rat) vapor mg/L/6 h/day Inhalation (rat) dust/mist/fume (rats) mg/L/6 h/day Guidance values (dose/concentration) 10 20 50 0.2 0.02
Table 22 Guidance values to assist in Category 2 classification Route of exposure Guidance Value Ranges a Oral (rats) 10 c < 100 mg/kg bodyweight/day Dermal (rat or rabbit) 20 c < 200 mg/kg bodyweight/day Inhalation (rat) gas 50 c < 250 L/L (ppm)/6 h/day Inhalation (rat) vapor 0.2 c < 1.0 mg/L/6 h/day Inhalation (rat) dust/mist/fume (rats) 0.02 c < 0.2 mg/L/6 h/day a Guidance proposed values are referred to toxic effects observed in a 90-day standard toxicity studies with rats. NOTE c is the concentration of ingredients/substances
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5.10.2 Classification criteria for mixtures 5.10.2.1 Classification of mixtures when data are available for the complete mixture When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture can be classified by weight of evidence evaluation of these data. Care should be exercised in evaluating data on mixtures that the dose used does not render the results inconclusive. 5.10.2.2 Classification of mixtures when data are not available for the complete mixture: Bridging Principles NOTE Where the mixture itself has not been tested to determine its specific target organ/systemic toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 5.10.2.2.1 Dilution
If a mixture is diluted with a substance that has an equivalent or lower toxicity classification than the least toxic original ingredient, and which is not expected to affect the toxicity of other ingredients, then the new mixture may be classified as equivalent to the original mixture. 5.10.2.2.2 Baching
The toxicity of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product, and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the toxicity of the batch has changed. If the latter occurs, new classification is necessary. 5.10.2.2.3 Concentration of highly toxic mixtures
If a mixture is classified in Category 1, and the concentration of one of the toxic ingredients of the mixture that are in Category 1 within one category If mixtures A and B are in the same classification category and mixture C is made in which the toxicologically active components have concentrations intermediate to those in mixtures A and B, then mixture C is assumed to be in the same category as A and B. 5.10.2.2.5 Substantially similar mixtures
Given the following: a) Two mixtures: 1) 2) b) c) A + B; C + B;
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2);
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d) Classification for A and C for toxicity are available and are the same, i.e. they are in the same hazard category and are not expected to affect the toxicity of B.
Then there is no need to test mixture (2) if mixture (1) is already characterized by testing and both mixtures would be classified in the same category. 5.10.2.2.6 Aerosols
An aerosol form of a mixture may be classified in the same hazard category as the tested, non-aerosolized form of the mixture for oral and dermal toxicity provided the added propellant does not affect the toxicity of the mixture on spraying. Classification of aerosolized mixtures for inhalation toxicity should be considered separately 5.10.2.3 Classification of mixtures when data are available for all components or only for some components of the mixture Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture will be classified as a specific target organ/systemic toxicant (specific organ specified), following single exposure, repeated exposure, or both when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ/systemic toxicant and is present at or above the appropriate cut-off value/concentration limit as mentioned in Table 23 for Category 1 and 2 respectively. Table 23 shows the ingredient concentrations in a mixture that triggers its classification in hazard categories. Table 23 Cut-off values/concentration limits of ingredients of a mixture classified as specific target organ/systemic toxicant that trigger the classification Ingredient classification Category 1 Specific target organ systemic toxicant Category 2 Specific target organ systemic toxicant 5.10.3 Decision logic Diagrams Figures 18 e 19 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic. Cut-off/concentration limits Category 1 Category 2 1,0 % 1,0 %
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Substance: Does the substance have data and/or information to evaluate specific target organ systemic toxicity following repeated exposure? Yes Classification not possible
No
Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate specific target organ systemic toxicity following repeated exposure? Yes Mixture: Does the mixture as a whole have data/information to evaluate specific target organ systemic toxicity following repeated exposure? Yes
No
No
See Figure 19
Following repeated exposure, Can the substance or mixture produce significant toxicity in humans, or Can it be presumed to have the potential to produce significant toxicity in humans on the basis of evidence from studies in experimental animals? Check criteria and guidance values. Application of the criteria needs expert judgment in a weight of evidence approach. No
Following repeated exposure, can the substance or mixture be presumed, to have the potential on the basis of evidence from studies in experimental animals, to be harmful to human health? Check criteria and guidance values. Application of the criteria needs expert judgment in a weight of evidence approach.
Categoria 2 Yes Warning
No Not classified
Figure 18 Decision logic for classification of target organ systemic toxicity from repeated exposure
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Yes
Does the mixture contain one or more ingredients classified as a Category 1 specific target organ systemic toxicant at a concentration 1,0 %? See Table 23 for explanation of cut-off values/concentration limits. No
Does the mixture contain one or more ingredients classified as a Category 2 specific target organ systemic toxicant at a concentration 1,0 %? See Table 23 for explanation of cut-off values/concentration limits. No Not classified
Figure 19 Decision logic for classification of target organ systemic toxicity from single exposure Classification of mixtures based on ingredients information
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ABNT NBR 14725-2:2009 5.11 Aspiration hazard

5.11.1 Classification criteria Aspiration toxicity includes severe acute effects such as chemical pneumonia, varying degrees of pulmonary injury or death following aspiration. Table 24 has the criteria parameters for classification of toxicity aspiration hazards . Table 24 Hazard categories for aspiration toxicity Categories Criteria A substance is classified in Category 1 based on Chemicals known to cause human aspiration reliable and good quality human evidence (a) or, if it is a 1 toxicity hazards or to be regarded as if they hydrocarbon and has a kinematic viscosity of 20.5 cause human aspiration toxicity hazard mm2/s or less, measured at 40 C. A substance is classify in Category 2 on the basis of existing animal studies and expert judgment that takes Chemicals that probably cause human into account surface tension, water solubility, boiling 2 aspiration toxicity hazard. point, and volatility, substances, other than those classified in Category 1, which have a kinematic viscosity of 14 mm2/s or less, measured at 40 C a Examples of substances included in Category 1 are certain hydrocarbons, turpentine and pine oil. 5.11.2 Classification criteria for mixtures 5.11.2.1 Classification of mixtures when data are available for the complete mixture A mixture is classified in Category 1 based on reliable human evidence.
5.11.2.2 Classification of mixtures when data are not available for the complete mixture: Bridging Principles NOTE Where the mixture itself has not been tested to determine its aspiration toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterize the hazard of the mixture, these data will be used in accordance with the following bridging principles. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity of additional testing in animals. 5.11.2.2.1 Dilution
If a mixture is diluted with a substance that does not pose an aspiration toxicity hazard, and which is not expected to affect the aspiration toxicity of other ingredients or the mixture, then the new mixture may be classified as equivalent to the original mixture. However, the concentration of aspiration toxicant(s) should not drop below 10%. 5.11.2.2.2 Batching
The aspiration toxicity of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product, and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the aspiration toxicity, reflected by viscosity or concentration, of the batch has changed. If the latter occurs, new classification is necessary.
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5.11.2.2.3 Concentration of Category 1 mixtures
If a mixture is classified in Category 1, and the concentration of one of the toxic ingredients of the mixture that are in Category 1 is increased, the new mixture should be classified in Category 1 without additional testing. 5.11.2.2.4 Interpolation within one category
If mixtures A and B are in the same classification category and mixture C is made in which the toxicologically active components have concentrations intermediate to those in mixtures A and B, then mixture C is assumed to be in the same category as A and B. 5.11.2.2.5 Substantially similar mixtures
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Aspiration toxicity for A and C is equivalent, i.e. they are in the same hazard category and are not expected to affect the aspiration toxicity of B.
If mixture (1) is already classified by testing, then mixture (2) can be assigned the same hazard category. 5.11.2.2.6 Classification of mixtures when data are available for all components or only for some components of the mixture
5.11.2.2.6.1 Category 1 A mixture that contains a total of 10% or more of a substance or substances classified in Category 1, and has a kinematic viscosity of 20.5 mm2/s or less, measured at 40 C, will be classified in Category 1. In the case of a mixture that separates into two or more distinct layers, one of which contains 10 %, more of a substance or substances classified in Category 1 and has a kinematic viscosity of 20.5 mm 2/s, or less, measured at 40 C, then the entire mixture is classified in Category 1. 5.11.2.2.6.2 Category 2 A mixture that contains a total of 10% or more of a substance or substances classified in Category 2, and has a kinematic viscosity of 14.0 mm2/s or less, measured at 40 C, will be classified in Category 2. In classifying mixtures in this category, the use of expert judgment that considers surface tension, water solubility, boiling point, volatility is critical and especially when Category 2 substances are mixed with water. In the case of a mixture that separates into two or more distinct layers, one of which contains 10 %, more of a substance or substances classified in Category 2 and has a kinematic viscosity of 14.0 mm 2/s, or less, measured at 40 C, then the entire mixture is classified in Category 2.
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5.11.3 Decision logic diagrams Figures 20 and 21 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic. Substance: Does the substance have aspiration toxicity data? No Classification not possible
Yes
Mixture: Does the mixture as a whole or its ingredients have aspiration toxicity data? Yes Mixture: Does the mixture as a whole show aspiration toxicity based on practical experience in humans from reliable and good quality evidence? Yes
No
No
See Figure 21
Category 1
Is there practical experience in humans from reliable and good quality evidence, for example, certain hydrocarbons, turpentine and pine oil, or is the substance a hydrocarbon with a kinematic viscosity of 20.5 mm2/s or less measured at 40 C? No
Yes
Danger
Category 2 Is there evidence-causing concern based on animal studies and expert judgment, and does the substance have a kinematic viscosity of 14 mm2/s or less, measured at 40 C? No Not classified Yes Warning
Figure 20 Decision Logic Diagram for classification of aspiration toxicity
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Yes
Does the mixture contain 10% or more of a substance or substances classified in Category 1 and have a kinematic viscosity of 20.5 mm2/s or less measured at 40 C? No
Category 1 Yes
Danger
Does the mixture contain 10% or more of a substance or substances classified in Category 2 and have a kinematic viscosity of 14 mm2/s or less measured at 40 C? No Not classified
Figure 21 Decision Logic Diagram for classification of aspiration toxicity - Classification of mixtures based on the ingredients information
6 Hazardous to the aquatic environment

The hazards of pure substances and mixtures due to their toxic properties to the environment should be evaluated through the ecotoxicological properties of the substances and mixtures undergoing classification (see Annex A). Whenever the formula of the mixture is modified with a variation in mass or volume, a new evaluation and hazard classification should be performed. This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification. Experimental data already generated for substances and mixtures previously classified by other existing systems should be accepted when applied to the classification of these chemicals in GHS, thereby avoiding duplicative testing and unnecessary use of laboratory animals.
6.2
Classification criteria for substances
The harmonized classification system for substances consists of three acute classification categories and four chronic classification categories. The acute and the chronic classification categories are applied independently. The criteria for classification of a substance in acute categories 1 to 3 are defined based on the acute toxicity data only (EC50 or LC50).
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The criteria for classification of a substance into chronic categories combine two types of information, i.e. acute toxicity data and environmental fate data (degradability and bioaccumulation data). For assignment of mixtures to chronic categories, degradation and bioaccumulation properties are derived from tests on components. Substances are classified according to the criteria of Table 25 for acute and toxic toxicity to the aquatic environment. Table 25 Categories for substances hazardous to the aquatic environment Acute and chronic toxicity in mg/L 96 hr LC50 (for fish) c1 1 EC50 (for crustacea) c1 72 or 96hr ErC50 (for algae or other aquatic plants) c1 96 hr LC50 (for fish) 1 < c 10 Acute 2 EC50 (for crustacea) 1 < c 10 toxicity 72 or 96hr ErC50 (for algae or other aquatic plants) 1 < c 10 96 hr LC50 (for fish) 10 < c 100 3 EC50 (for crustacea) 10 < c 100 72 or 96hr ErC50 (for algae or other aquatic plants) 10 < c 100 96 hr LC50 (for fish) c1 1a EC50 (for crustacea) c1 72 or 96hr ErC50 (for algae or other aquatic plants) c 1 96 hr LC50 (for fish) 1 < c 10 2b EC50 (for crustacea) 1 < c 10 72 or 96hr ErC50 (for algae or other aquatic plants) 1 < c 10 96 hr LC50 (for fish) 10 < c 100 Chronic 3b EC50 (for crustacea) 10 < c 100 toxicity 72 or 96hr ErC50 (for algae or other aquatic plants) 10 < c 100 Poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not rapidly degradable and have a log Kow 4, indicating a potential to bioaccumulate, will be classified in this 4 category unless other scientific evidence exists showing classification to be unnecessary. Such evidence would include an experimentally determined BCF < 500, or a chronic toxicity NOECs (non observed effect concentration) > 1 mg/l, or evidence of rapid degradation in the environment. a If the substance is not rapidly degradable and/or if log10Kow 4. Do not consider log 10 Kow if value of BFC < 500 obtained from laboratory experiments. b If the substance is not rapidly degradable and/or if log10Kow 4 (do not consider log 10 Kow if value of BFC < 500 obtained from laboratory experiments), unless the chronic toxicity NOEC is > 1 mg/l. NOTE c means LC50 or ECr50 or EC50. NOTE The classification of mixtures based on the principles of additivity and in the summation method of ingredients is detailed presented in GHS. Category
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6.3.1
Classification criteria for mixtures

Flow diagram for classification
The classification system for mixtures covers all classification categories which are used for substances meaning Acute Categories I to III and Chronic Categories I to IV. In order to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following assumption has been made and is applied where appropriate. The relevant components of a mixture are those which are present in a concentration of 1% (weight/weight) or greater, unless there is a presumption (e.g. in the case of highly toxic components) that a component present at less than 1% can still be relevant for classifying the mixture for aquatic environmental hazards. The approach for classification of aquatic environmental hazards depends upon the type of information available for the mixture itself and for its components. The approach elements include: a) b) c) Classification based on tested mixtures; Classification based on bridging principles; The use of summation of classified components and /or an additivity formula. Figure 22 outlines the process to be followed. Aquatic environment toxicity test data available on the mixture Aquatic environment toxicity test data available on the mixture No Yes Classify for acute/chronic toxicity hazard (see 6.3.2) Classify for acute/chronic toxicity hazard
Sufficient data available on similar mixtures to estimate hazards No Classification data available for toxicity in water for all relevant components No Use available hazard data of known components No See 6.3.9
Yes
Apply bridging principle (see 6.3.3)
Yes
Apply bridging principle (see 6.3.3)
Classify for acute/chronic toxicity hazard
Yes
Apply Summation Method and/or Additive Formula (see 6.3.4)
Classify for acute/chronic toxicity hazard
Figure 22 Flow diagram for classification of mixtures for acute and chronic aquatic environmental hazards
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6.3.2 Classification of mixtures when data are available for toxicity of aquatic organisms
When the mixture as a whole has been tested to determine its aquatic toxicity, it can be classified according to the criteria that have been agreed for substances, but only for acute toxicity. The classification should be based on the data for fish, crustacea and algae/plants. Classification of mixtures by using LC50 or EC50 data for the mixture as a whole is not possible for chronic categories since both toxicity data and environmental fate data are needed, and there are no degradability and bioaccumulation data for mixtures as a whole. It is not possible to apply the criteria for chronic classification because the data from degradability and bio-accumulation tests of mixtures cannot be interpreted; they are meaningful only for single substances. When there is acute toxicity test data (LC50 or EC50) available for the mixture as a whole, this data as well as information with respect to the classification of components for chronic toxicity should be used to complete the classification for tested mixtures as follows. When chronic (long-term) toxicity data (NOEC) is also available, this should be used as follows: a) LC50 or EC50 of the tested mixture 100mg/l and NOEC of the tested mixture 1.0 mg/l or unknown: 1) 2) b) Classify mixture as Category Acute 1, 2 or 3; Apply Summation of Classified Components approach (see items that follows) for chronic classification (Chronic 1, 2, 3, 4 or no need of chronic classification);
LC50 or EC50 of the tested mixture 100 mg/L and NOEC of the tested mixture > 1,0 mg/L: 1) 2) Classify mixture as Category Acute 1, 2 or 3; Apply Summation of Classified Components approach for Chronic classification 1 (If mixture is not classified as Category Chronic 1 there is no need for chronic classification);
c)
CLC50 or EC50 of the tested mixture >100mg/L, or above the water solubility, and NOEC of the tested mixture 1.0mg/L or unknown: 1) 2) No need to classify for acute toxicity hazard. Apply Summation of Classified Components approach for Chronic classification (Category Chronic 4 or no need for chronic classification);
d) 6.3.3
LC50 or EC50 of the tested mixture >100mg/L, or above the water solubility, and NOEC of the tested mixture > 1.0mg/L, no need for either chronic or acute toxicity classification. Classification of mixtures when aquatic data assays are not available for the mixture: Bridging principles
NOTE Where the mixture itself has not been tested to determine its aquatic environmental hazard, but there are sufficient data on the individual components and similar tested mixtures to adequately characterize the hazards of the mixture, this data will be used in accordance with the following agreed bridging rules. This ensures that the classification process uses the available data to the greatest extent possible in characterizing the hazards of the mixture without the necessity for additional testing in animals. 6.3.3.1 Dilution
If a mixture is formed by diluting another classified mixture or a substance with a diluent which has an equivalent or lower aquatic hazard classification than the least toxic original component and which is not expected to affect the aquatic hazards of other components, then the new mixture may be classified as equivalent to the original mixture.
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6.3.3.2 Batching
The aquatic hazard classification of one production batch of a complex mixture can be assumed equivalent to that of another production batch of the same commercial product and produced by or under the control of the same manufacturer, unless there is reason to believe there is significant variation such that the aquatic hazard classification of the batch has changed. If the latter occurs, new classification is necessary. 6.3.3.3 Concentration of mixtures which are classified with the most severe classification categories (Chronic 1 and/or Acute 1) If a mixture is classified as Chronic 1 and/or Acute 1, and components of the mixture which are classified as Chronic 1 and/or Acute 1 are further concentrated, the more concentrated mixture should be classified with the same classification category as the original mixture without additional testing. 6.3.3.4 Interpolation within one toxicity category
If mixtures A and B are in the same classification category and mixture C is made in which the toxicologically active components have concentrations intermediate to those in mixtures A and B, then mixture C is assumed to be in the same category as A and B. 6.3.3.5 Substantially similar mixtures
Given the following: a) Two mixtures:: 1) 2) b) c) A + B; C + B;
The concentration of component B is the same in both mixtures; The concentration of component A in mixture (1) equals that of component C in mixture (2); Classification for A and C are available and are the same, i.e. they are in the same hazard category and are not expected to affect the aquatic toxicity of B.
d)
Then there is no need to test mixture (2) if mixture (1) is already characterized by testing and both mixtures would be classified in the same category. 6.3.4 Classification of mixtures when data are available for all components or only for some components of the mixture The classification of a mixture is based on summation of the classification of its components. In this case, apply the Summation Method or the Additive Formula as advised in GHS book. 6.3.5 Classification procedure
In general, a more severe classification for mixtures overrides a less severe classification. For instance, a classification with Chronic 1 overrides a classification with Chronic 2. Consequently, the classification procedure is already completed if the result of the classification is Chronic 1. A more severe classification than Chronic 1 is not possible, therefore, it is not necessary to undergo the further classification procedure.
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6.3.6 Classification for the Acute Categories 1, 2 and 3
First, all components classified as Acute 1 are considered. If the sum of these components is greater than 25% the whole mixture is classified as Category Acute 1. If the result of the calculation is a classification of the mixture as Category Acute 1, the classification process is completed. In cases where the mixture is not classified as Acute 1, classification of the mixture as Acute 2 is considered. If the result of the calculation is classification of the mixture as Category Acute 2, the classification process is completed. If the result of the calculation is classification of the mixture as Category Acute 2, the classification process is completed. In cases where the mixture is not classified either as Acute 1 or as Acute 2, classification of the mixture as Acute 3 is considered. A mixture is classified as Acute 3 if 100 times the sum of all components classified as Acute 1, plus 10 times the sum of all components classified as Acute 2, plus the sum of all components classified as Acute 3 is greater than 25%. The classification of mixtures for acute hazards based on this summation of classified components, is summarized in Table 26. Table 26 Classification of a mixture for acute hazards, based on summation of classified components Mixture is classified as: Acute 1 x M a > 25 % Acute 1 (M x 10 x acute 1) + acute 2 > 25 % Acute 2 (M x 100 x acute 1) + (10 x acute 2) + acute 3 > 25 % Acute 3 a M is a multiplier factor to the base 10 (see 6.3.8) (see 6.3.8). Sum of components classified as:
6.3.7
Classification for the Chronic Categories 1, 2, 3 and 4
First, all components classified as Chronic 1 are considered. If the sum of these components is greater than 25%, the whole mixture is classified as Category Chronic 1. If the result of the calculation is a classification of the mixture as Category Chronic 1, the classification process is completed. In cases where the mixture is not classified as Chronic 1, classification of the mixture as Chronic 2 is considered. A mixture is classified as Chronic 2 if ten times the sum of all components classified as Chronic 1, plus the sum of all components classified as Chronic 2, is greater than 25%. If the result of the calculation is classification of the mixture as Category Chronic 2, the classification process is completed. In cases where the mixture is not classified as either Chronic 1 or Chronic 2, classification of the mixture as Chronic 3 is considered. A mixture is classified as Chronic 3 if 100 times the sum of all components classified as Chronic 1 plus 10 times the sum of all components classified with Chronic 2 plus the sum of all components classified as Chronic 3 is greater than 25%. The classification of mixtures for chronic hazards, based on this summation of classified components, is summarized in Table 27.
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Table 27 Classification of a mixture for chronic hazards, based on summation of classified components Sum of ingredients Chronic 1 x Ma > 25 % (M x_10 x Chronic 1) + Chronic 2 > 25 % (M x 100 x Chronic 1) + (10 x Chronic 2) + Chronic 3 > 25 % Chronic 1 + Chronic 2 + Chronic 3 +Chronic 4 > 25 % a M is a multiplier factor to the base 10 (see 6.3.8). Mixture classification Chronic 1 Chronic 2 Chronic 3 Chronic 4
6.3.8 Mixtures with highly toxic components Acute Category 1 components with toxicities well below 1 mg/l may influence the toxicity of the mixture and should be given increased weight in applying the summation of classification approach. Values to be used in these cases are in Table 28. Table 28 Multiplying factors for highly toxic components (Category 1) of mixtures LC50 or EC50 values Multiplying factor (M) mg/L 0,1 < c 1 1 0,01 < c 0,1 10 0,001 < c 0,01 100 0,0001 < c 0,001 1 000 0,00001 < c 0,0001 10 000 NOTE 1 Continues in 10s intervals. NOTE 2 c means either LC50 or EC50
6.3.9
Classification of mixtures with components without any useable information
In the event that no useable information on acute and/or chronic aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed a definitive hazard category(ies). In this situation the mixture should be classified based on the known components only, with the additional statement that x percent of the mixture consists of components(s) of unknown hazards to the aquatic environment
6.4
Decision logic diagrams
Figures 23, 24, and 25, can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
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Substance: Is there sufficient information (toxicity, degradation bioaccumulation) for classification? Yes
No
Go to Figure 24
Acute Category 1
Acute toxicity Does it have a:

96 hr LC50 (fish) 1 mg/L? and/or 48 hr EC50 (crustacea) 1 mg/L? and/or 72 or 96 hr ErC50 (algae or other aquatic plants) 1 mg/L? No and Chronic Category 1 Yes Warning Acute Yes Category 2 Yes Warning
Chronic toxicity
Does it not degrade rapidly; and/or Does it have the potential to
bioaccumulate? (BCF> 500 or in absence, log10 Kow 4?)

96 hr LC50 (fish) 10 mg/L? and/or 48 hr EC50 (crustacea) 10 mg/L? and/or 72 or 96 hr ErC50 (algae or other aquatic plants) 10 mg/L? No and
Chronic toxicity
Does it lack the potential to rapidly degrade; and/or Does it have the potential to bioaccumulate? (BCF 500 ou na falta, log10 Kow 4)? No
Chronic Category 2 Yes
Unless chronic NOEC(s) >1 mgL
Figure 23 Decision logic diagram for hazard classification in aquatic environment
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No

96 hr LC50 (fish) 100 mg/L? and/or 48 hr EC50 (crustacea) 100 mg/L? and/or 72 or 96 hr ErC50 (algae or other aquatic plants) 100 mg/L? No and Yes
Acute Category 3
Chronic toxicity
Does it not degrade rapidly; and/or Does it have the potential to bioaccumulate? (BCF> 500 or in absence, log10 Kow 4?) Yes
Chronic Category 3
Unless chronic NOEC(s) >1 mg/L
Chronic toxicity
Is it poorly soluble with no acute toxicity? and Does it not degrade rapidly? and Does it have the potential to bioaccumulate? (BCF 500 or if absent, log10 Kow 4)? Yes
Chronic Category 4
Unless chronic NOEC(s) >1 mg/L
No
Not classified
Figure 23 (continuing)
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Mixture: Does the mixture as a whole have aquatic toxicity data for fish, crustacea, and algae/aquatic plants? Yes
Values from mixtures/decision logic Figure 24
No

96 hr LC50 (fish) 1 mg/L? and/or 48 hr EC50 (crustacea) 1 mg/L? and/or 72 or 96 hr ErC50 (algae or other aquatic plants) 1 mg/L? No and Yes
Acute Category 1
Warning

96 hr LC50 (fish) 10 mg/L? and/or 48 hr EC50 (crustacea) 10 mg/L? and/or 72 or 96 hr ErC50 (algae or other aquatic plants) 10 mg/L? Yes Acute Category 2

96 hr LC50 (fish) 100 mg/L? and/or 48 hr EC50 (crustacea) 100 mg/L? and/or 72 or 96 hr ErC50 (algae or other aquatic plants) 100 mg/L? Acute Category 3
and
Yes
and
No Not classified for acute toxicity
Chronic toxicity
See Figure 25
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No Classify in appropriate category
Yes
Use all available ingredient information in the summation method as follows: For ingredients with available toxicity value(s) apply the additive formula (see Figure 22) , determine the toxicity category for that part of the mixture and use this information in the summation method; Classified ingredients will feed directly into the summation method below.
Yes Sum of ingredients classified as Acute 1 M 25%? No Sum of ingredients classified as (Acute 1 M 10) + Acute 2 25%?
Help Category 1 Yes Warning
and
Yes
Help Category 2
No
and
Sum of ingredients classified as (Acute 1 M 100) + (Acute 2 x 10) + Acute 3 25%?

and
Yes
Help Category 3
No
Not classified for acute
Chronic toxicity
See Figure 25
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where Ci is the ingredient concentration i; L(E)C50m is the part of the mixture with test data; n is the number of components; L(E)Cocc is the CL50 or the CE50 for the component.
Mixture value Go back to Figure 23
Figure 24 Decision logic diagram for hazard classification in aquatic environment - Mixture Summation method Chronic Category 1 Sum of ingredients classified as Chronic 1 M 25%? No Yes Warning Chronic Category 2 Yes
Sum of ingredients classified as [(Chronic toxicity 1 x M x 10) + (Chronic toxicity 2)] 25 %?
No
Sum of ingredients classified as [(Chronic toxicity 1 x M x 100) + (Chronic toxicity 2 x 10) + (Chronic toxicity 3)] 25 %? No Sum of Ingredient classification (Chronic toxicity 1 + Chronic toxicity 2 + Chronic toxicity 3 + Chronic toxicity 4) 25 %?
Yes
Chronic Category 3
Yes
Chronic Category 4
No
Not classified as Chronic toxicity
Figure 25 Decision logic diagram to assess chronic hazards to the environment
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7 Physical hazards
Hazards associate to substances and mixtures are assessed through their physic-chemical properties applying the methods outlined on the UN Manual of Tests and Criteria, using for substances classification for the transport of dangerous goods. It is not necessary to determine the explosibility, combustion or flammability of certain mixture if: any of its ingredients present such properties based on information available from the manufacturer and if it is not probable that the mixture poses such type of hazard. this is a change in the composition of a mixture of known composition and there is valid scientific justification for considering that this modification does not affect the classification of the mixture. Experimental data already generated for substances and mixtures previously classified by other existing systems should be accepted when applied to the classification of these chemicals in the GHS, thereby avoiding duplication of testing. For classification of gases and their mixtures (flammable gases, aerosols, gases and oxidizing gases under pressure) and organic peroxides, additional information can be obtained in the GHS.
7.2
a)
Classification criteria for substances, mixtures and explosive articles

Division 1.1: Substances, mixtures and articles which have a mass explosion hazard; Division 1.2: Substances, mixtures and articles which have a projection hazard but not a mass explosion hazard; Division 1.3: Substances, mixtures and articles which have a fire hazard and either a minor blast hazard or a minor projection hazard or both, but not a mass explosion hazard: 1) 2) Combustion of which gives rise to considerable radiant heat; or; which burn one after another, producing minor blast or projection effects or both;
Substances, mixtures and explosive articles are classified according to the criteria that follow:
b) c)
d)
Division 1.4: Substances, mixtures and articles which present no significant hazard: substances, mixtures and articles which present only a small hazard in the event of ignition or initiation. An external fire shall not cause virtually instantaneous explosion of almost the entire contents of the package; Division 1.5: Very insensitive substances or mixtures which have a mass explosion hazard: substances and mixtures which have a mass explosion hazard but are so insensitive that there is very little probability of initiation or of transition from burning to detonation under normal conditions; Division 1.6: Extremely insensitive articles which do not have a mass explosion hazard: articles which contain only extremely insensitive detonating substances or mixtures and which demonstrate a negligible probability of accidental initiation or propagation.
e)
f)
The classification criteria for substances, mixtures and explosives are summarized in Table 29.
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Table 29 Classification criteria for substances, mixtures and explosive articles Criteria Explosibility: according to UN Test Series 2 from the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Part 1, Section 12 Unstable substances, Sensitiveness: according to UN Test Series 3 from the UN mixtures and articles or Recommendations on the Transport of Dangerous Goods, Manual explosives in Divisions of Tests and Criteria, Part 1, Section 13 1.1 - 1.6 Thermal stability: according to UN Test Series 3c from the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Part 1, Subsection 13.6.1 NOTE Further tests are necessary to allocate the correct Division. Category
7.3
Classification criteria for flammable gases

Table 30 Classification criteria for flammable gases Category Criteria Gases, which at 20 C and a standard pressure of 101.3 kPa: a) are ignitable when in a mixture of 13% (volume/volume) or less in air; or b) have a flammable range with air of at least 12 percent regardless of the lower flammable limit.
A flammable gas is classified in one of the two categories for this class according to Table 30.
Gases, other than those of Category 1, which, at 20 C and a standard pressure of 101.3 kPa, have a flammable range while mixed in air.
Figure 26 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
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Gaseous substance or mixture of gases
Does it have a flammable range with air at 20 C and a standard pressure of 101.3 kPa? Yes
No
Not classified
At 20 C and a standard pressure of 101.3 kPa, does it: a) ignite when in a mixture of 13% or less by volume in air?; or b) has a flammable range with air of at least 12 percentage points regardless of the lower flammable limit? Yes
Category 1
Danger
No
Category 2
Warning
Figure 26 Decision logic for flammable gases
7.4
Classification criteria for flammable aerosols
Aerosols should undergo classification procedures and will be deemed flammable if contain any flammable classified ingredient according to the criteria outlined in 7.3, 7.7 and 7.8 for gases, liquids and solids. Figures 27, 28 e 29 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic. NOTE Classification of a flammable aerosol requires data on its flammable ingredients, combustion heat, and if applicable, results from the ignition distance test, enclosed space test (for spray aerosols), and foam test (for foam aerosols).
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Aerosol
Does it contain 1% flammable components and does it have a heat of combustion < 20 kJ/g? No
Yes
Not classified
Category 1 Does it contain 85 % flammable components and does it have a heat of combustion < 30 kJ/g?
Yes Danger
No
See Figure 28 (for spray aerosols) or see Figure 29 (for foam aerosols).
Figure 27 Decision logic for flammable aerosols
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ABNT NBR 14725-2:2009
Spray aerosol
Category 1
In the ignition distance test, does ignition occur at a distance 75 cm? No
Yes Danger
Category 2 Is the heat of combustion < 20 kJ/g? No Warning Yes
Category 2 In the ignition distance test, does ignition occur at a distance 15cm? Yes Warning
No
Category 2 In the enclosed space ignition test, is the flammability time equivalent 300 s/m3; or deflagration density 300 g/m ?
3
Yes Warning
No Not classified
Figure 28 Decision logic for spray aerosols
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Foam aerosol
Category 1 In the flammability foam test, is the (a) flame height 20 cm and the flame duration 2 s; or (b) flame height 4 cm and the flame duration 7 s? Danger No Yes
Category 2 In the foam test, is the flame height 4 cm and the flame duration 2 s? Yes Warning No Not classified
Figure 29 Decision logic for foam aerosols
7.5
Criteria for classification of oxidizing gases
Oxidizing gas is any gas causing or contributing more than air for the combustion of another material, generally because it provides oxygen. Oxidizing gases should be classified in one single category (Category 1). Figure 30 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
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ABNT NBR 14725-2:2009

Gaseous substance or mixture of gases
Category 1
Does the gas contribute to the combustion of other material more than air does?
No
Yes Danger
Not classified
Figure 30 Decision logic for oxidizing gases
7.6
Criteria for classification of gases under pressure
Gases under pressure are compressed, liquefied, dissolved under pressure or liquid refrigerated gases. Gases under pressure should be classified within one of the groups of Table 31. Table 31 Criteria for classification of gases under pressure
Group Compressed gas
Liquefied gas
Criteria Gas that when packaged under pressure is entirely gaseous at -50 C; including all gases with a critical temperature -50 C. A gas, which when packaged under pressure is partially liquid at temperatures above -50 C is different from: High pressure liquefied gas, whose critical temperature is between -50C and +65C; and Low pressure liquefied gas, whose critical temperature is above +65C.
Refrigerated liquefied gas Dissolved gas
Gas that when packaged is made partially liquid because of its low temperature. Gas that when packaged under pressure is dissolved in a liquid phase solvent.
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Substance or mixture
Is: (a) the vapor pressure at 50 C greater than 3 bar?; or (b) the substance or mixture completely gaseous at 20C and 101.3kPa?
No
Not classified Dissolved gas
Yes Is the gas dissolved in a liquid solvent under pressure? No Liquefied gas Is the critical temperature above +65 C? No Yes Warning Liquefied gas Is the critical temperature between 50 C and +65 C? No Yes Warning Refrigerated liquefied gas Yes
Warning
Is the gas made partially liquid because of its low temperature? No
Yes
Warning Compressed gas
Is the gas entirely in gaseous state at 50 C
Yes
Warning
Figure 31 Decision logic for gases under pressure
80
Em ensaio de queima distncia h inflamabilidade No Categoria 1 SimPerigo Freely available Standard through an ABNT-ABIQUIM a uma distncia 75 cm?
Agreement
ABNT NBR 14725-2:2009 7.7 Criteria classification for flammable liquids

Table 32 Criteria for flammable liquids Category 1 2 3 4 Criteria Flash point < 23 C and initial boiling point 35 C Flash point < 23 C and initial boiling point > 35 C Flash point 23 C and 60 C Flash point > 60 C and < 93 C
A flammable liquid is classified in one of the categories of Table 32.
The substance or mixture is a liquid
Does it have a flash point 93 C? Yes
No
Not classified
Category 4
Does it have a flash point > 60C? No
Yes Warning
Category 3 Does it have a flash point 23C? No Yes Warning
Category 2 Does it have an initial boiling point > 35C? Yes Danger No Category 1
Danger
Figure 32 Decision logic for flammable liquids
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ABNT NBR 14725-2:2009 7.8 Criteria classification for flammable solids

Table 33 Criteria for flammable solids Category a) 1 b) a) 2 b) Criteria Burning rate test Substances or mixtures other than metal powders: Wetted zone does not stop fire and; Burning time < 45 s or burning rate > 2.2 mm/s. Metal powders: burning time 5 min. Substances or mixtures other than metal powders: Wetted zone stops the fire for at least 4 min and Burning time < 45 s or burning rate > 2.2 mm/s. Metal powders: burning time > 5 min and 10 min
A flammable solid should be classified in one of the categories of Table 33.
Figure 33 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic as set forth on UN Manual of Tests and Criteria.
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Substance or solid mixture
Screening test Positive
Negative
Not classified
Burning rate test: For substances or mixtures other than metal powders: Burning time < 45 s or burning rate > 2.2 mm/s? ; or Metal powders: burning time 10 min ?
No
Not classified
Yes
For substances or mixtures other than metal powders: Does the wetted zone stop propagation of the flame? Metal powders: burning time > 5 min?
Category 1 No Danger
Yes
Category 2
Warning
Figure 33 Decision logic for flammable solids
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ABNT NBR 14725-2:2009 7.9 Classification criteria for self-reactive substances and mixtures - Substances liable to spontaneous combustion
They are explosives, according to criteria on 7.2; They are organic peroxides, according to criteria on 7.16; Their heat of decomposition is less than 300 J/g; Their self-accelerating decomposition temperature (SADT) is greater than 75 C for a 50 kg package, or They are oxidizing liquids or solids, according to the criteria on 7.14 and 7.15 respectively, except that mixtures of oxidizing substances that contain 5% or more of combustible organic substances, which should be classified as self-reactive substances.
Any self-reactive substance or mixture should be considered for classification in this class unless: a) b) c) d) e)
Mixtures of oxidizing substances, meeting the criteria for classification as oxidizing substances, which contain 5.0% or more of combustible organic substances and which do not meet the criteria mentioned in (a), (b), (c) or (d) above, shall be subjected to the self-reactive substances classification procedure. Self-reactive substances and mixtures are classified in one of the seven categories of (types A to G) for this class, according to the following principles: a) b) c) Type A: Any self-reactive substance or mixture, which can detonate or deflagrate rapidly, as packaged; Type B: Any self-reactive substance or mixture possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package; Type C: Any self-reactive substance or mixture possessing explosive properties when the substance or mixture as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion; Type D: Any self-reactive substance or mixture which in laboratory testing: 1) 2) 3) e) f) detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; does not detonate or deflagrate at all and shows a medium effect when heated under confinement;
d)
Type E: Any self-reactive substance or mixture which, in laboratory testing, neither detonates nor deflagrates at all and shows low or no effect when heated under confinement; Type F: Any self-reactive substance or mixture which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows only a low or no effect when heated under confinement as well as low or no explosive power; Type G: Any self-reactive substance or mixture which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows no effect when heated under confinement nor any explosive power, provided that it is thermally stable (self-accelerating decomposition temperature is 60 C to 75 C for a 50 kg package), and, for liquid mixtures, a diluent having a boiling point not less than 150 C is used for desensitization. If the mixture is not thermally stable or a diluent having a boiling point less than 150 C is used for desensitization, the mixture shall be defined as self-reactive substance Type F.
g)
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ABNT NBR 14725-2:2009 7.10 Criteria classification for pyrophoric liquids

A pyrophoric liquid is a liquid which is liable to ignite within five minutes if placed over an inert material or on a filter -paper (which is carbonized) after coming into contact with air. Pyrophoric liquids should be classified in one single category (Category 1). Figure 34 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic. NOTE The classification procedure for pyrophoric liquids need not be applied when experience in production or handling shows that the substance or mixture does not ignite spontaneously on coming into contact with air at normal temperatures.
Substance or liquid mixture
Category 1 Does it ignite within 5 minutes after placed on a porcelain vessel with diatom earth or silica gel? Yes Danger No
Category 1 Provokes ignition or no flame combustion from a filterpaper in less than 5 min? Yes Danger No Not classified
Figure 34 Decision logic for pyrophoric liquid
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ABNT NBR 14725-2:2009 7.11 Criteria classification for pyrophoric solids

A pyrophoric solid is a solid that is liable to ignite within five minutes after coming into contact with air. Pyrophoric solids should be classified in one single category (Category 1). Figure 35 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
Category 1 Does it ignite within five minutes after coming into contact with air? No Not classified Yes Danger
Figure 35 Decision logic for pyrophoric solids
7.12 Classification criteria for self-heating substances and mixtures

A self-heating substance or mixture with self-heating capability is classified according to Table 34. Table 34 Classification criteria for self-heating substances or mixtures Category 1 2 Criteria It does self-heats in a test using a 25 mm sample cube at 140 C
a) It does self-heats in a test using a 100 mm sample cube at 140 C but it does not self-heats in a test using a 25 mm cube sample at 140 C and the substance or mixture was packed in packages with a volume of more than more than 3 m3; It does self-heats in a test using a 100 mm sample cube at 140 C, but it does not self-heats in a test using a 25 mm cube sample at 140 C, and it does self-heats in a test using a 100 mm cube sample at 120 C and the substance or mixture was packed in packages with a volume of more than 450 L It does self-heats in a test using a 100 mm sample cube at 140 C and It does not self-heats in a test using a 25 mm cube sample at 140 C and It does self-heats in a test using a 100 mm cube sample at 100 C.
b)
c)
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Does it undergo dangerous self-heating when tested in a 100 mm sample cube at 140 C? Yes
No
Not classified
Category 1
Does it undergo dangerous self-heating when tested in a 25 mm sample cube at 140 C? No
Yes Warning
Category 2 Is it packaged in more than 3 m3? Yes Danger
No
Does it undergo dangerous self-heating when tested in a 100 mm sample cube at 120 C? Yes
No
Not classified
Category 2 Is it packaged in more than 450 litres volume No Category 2 Does it undergo dangerous self-heating when tested in a 100 mm sample cube at 100 C? No Yes Warning Yes Warning
Not classified Figure 36 Decision logic for self-heating substances and mixtures
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ABNT NBR 14725-2:2009 7.13 Classification criteria for substances and mixtures which, in contact with water, emit flammable gases
A substance or mixture, which, in contact with water, emits flammable gases, should be classified in one of the categories of Table 35. Table 35 Classification criteria for substances and mixtures which, in contact with water, emit flammable gases Category 1 Criteria Any substance or mixture which reacts vigorously with water at ambient temperatures and demonstrates generally a tendency for the gas produced to ignite spontaneously, or which reacts readily with water at ambient temperatures such that the rate of evolution of flammable gas is equal to or greater than 10 liters per kilogram of substance over any one minute. Any substance or mixture which reacts readily with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 20 liters per kilogram of substance per hour, and which does not meet the criteria for Category 1. Any substance or mixture which reacts slowly with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 1 liter per kilogram of substance per hour, and which does not meet the criteria for Categories 1 and 2.
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In contact with water, does it react slowly at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 1 L/kg of substance per hour? Yes
No
Not classified
In contact with water, does the substance react vigorously with water at ambient temperatures and the gas produced is liable to ignite spontaneously, or does it react readily with water at ambient temperatures such that the rate of evolution of flammable gas is 10 L/kg of substance per minute? No
Category 2
In contact with water, does it react readily with water at ambient temperatures such that the maximum rate of evolution of flammable gas is 20 L/kg of substance per hour?
Yes Danger
No Category 3
Warning
Figure 37 Decision logic for substances and mixtures which, in contact with water, emit flammable gases
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ABNT NBR 14725-2:2009 7.14 Criteria classification for oxidizing liquids

An oxidizing liquid should be classified in one of the categories of the Table 36. Table 36 Criteria for oxidizing liquids Category Criteria Oxidizing liquid is any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, spontaneously ignites; or the mean pressure rise time of a 1:1 mixture, by mass, of substance and cellulose is less than that of a 1:1 mixture, by mass, of 50% perchloric acid and cellulose; Any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibits a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 40% aqueous sodium chlorate solution and cellulose; and the criteria for Category 1 are not met; Any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibits a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 65% aqueous nitric acid and cellulose; and the criteria for Categories 1 and 2 are not met.
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Substance or liquid mixture
Does it, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibits a pressure rise 2070 kPa gauge? Yes
No
Not classified
Does it, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibit a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 65% aqueous nitric acid and cellulose? Yes
No
Not classified
Does it, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibit a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 40% aqueous sodium chlorate and cellulose? Yes
Category 3 No Warning
Category 2 Does it, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, spontaneously ignite or exhibit a mean pressure rise time less than that of a 1:1 mixture, by mass, of 50% perchloric acid and cellulose? No Danger
Yes
Category 1
Danger
Figure 38 Decision logic for oxidant liquids
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ABNT NBR 14725-2:2009 7.15 Criteria classification for oxidizing solids

An oxidizing solid should be classified in one of the categories of Table 37. Table 37 Criteria for oxidizing solids Category 1 Criteria Oxidizing solid is any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time less than the mean burning time of a 3:2 mixture, by mass, of potassium bromate and cellulose. Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 2:3 mixture (by mass) of potassium bromate and cellulose and the criteria for Category 1 are not met. Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 3:7 mixture (by mass) of potassium bromate and cellulose and the criteria for Categories 1 and 2 are not met.
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Does it, in the 4:1 or 1:1 sample-to-cellulose ratio, by mass, tested ignite or burn?
No
Not classified
Yes
Does it, in the 4:1 or 1:1 sample-to-cellulose ratio, by mass, tested, exhibit a mean burning time less than or equal to the mean burning time of a 3:7 mixture, by mass, of potassium bromate and cellulose?
No
Not classified
Yes
Does it, in the 4:1 or 1:1 sample-to-cellulose ratio, by mass, tested, exhibit a mean burning time less than or equal to the mean burning time of a 2:3 mixture, by mass, of potassium bromate and cellulose? Yes
Category 3 No Warning
Does it, in the 4:1 or 1:1 sample-to-cellulose ratio, by mass, tested, exhibit a mean burning time less than the mean burning time of a 3:2 mixture, by mass, of potassium bromate and cellulose?
Category 2 No Danger
Yes Category 1
Danger
Figure 39 Decision logic for oxidant solids
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ABNT NBR 14725-2:2009 7.16 Classification criteria for organic peroxides

Any organic peroxide shall be considered for classification in this class, unless it contains: Not more than 1.0% available oxygen from the organic peroxides when containing not more than 1.0% hydrogen peroxide; or Not more than 0.5% available oxygen from the organic peroxides when containing more than 1.0% but not more than 7.0% hydrogen peroxide.
Organic peroxides should be classified in one of the seven categories (A - G) according to the following principles: a) b) c) d) Type A: Any organic peroxide that can detonate or deflagrate rapidly depending upon how it was packed; Type B: Any organic peroxide possessing explosive properties that neither detonates nor deflagrates rapidly after packed, but is liable to undergo a thermal explosion within that package; Type C: Any organic peroxide possessing explosive properties that cannot detonate or deflagrate rapidly or undergo a thermal explosion after packed; Type D: Any organic peroxide which has the following behavior in laboratory testing: 1) 2) 3) e) Detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or Does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or Does not detonate or deflagrate at all and shows a medium effect when heated under confinement:
Type E: Any organic peroxide that when tested in a laboratory neither detonates nor deflagrates at all and shows low or no effect when heated under confinement ; Type F: Any organic peroxide that when tested in a laboratory neither detonates in the cavitated state, nor deflagrates at all, and shows only a low or no effect when heated under confinement as well as low or no explosive power Type G: Any organic peroxide that when tested in a laboratory neither detonates in the cavitated state nor deflagrates completely not showing any effect when heated under confinement nor any explosive power, provided that it is thermally stable. (self-accelerating decomposition temperature is 60C or higher for a 50 kg package), and, for if a liquid mixtures is diluted with a diluent whose boiling point is above 150 C aiming at achieving desensitization, such mixture is classified as an organic peroxide type G. If the mixture was no stable or if the diluent boiling point is less than 150 C the mixture should be classified as Type F.
f)
g)
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ABNT NBR 14725-2:2009 7.17 Classification criteria for substances and mixtures corrosive to metals
A substance or a mixture that is corrosive to metals has a corrosion rate on steel or aluminium surfaces exceeding 6.25 mm per year at a test temperature of 55 C, and should be classified in a single category (Category 1). Figure 40 can be used as additional guidance for hazard classification. It is strongly recommended that the person responsible for classification study the criteria before and during use of the decision logic.
Does it corrode on steel or aluminium surfaces at a rate exceeding 6.25 mm/year at a test temperature of 55 C?
No
Not classified
Yes
Category 1
Warning
Figure 40 Decision logic for substances and mixtures corrosive to metal
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ABNT NBR 14725-2:2009

Anexo A (informativo) Mtodos de ensaios
Annex A (informative) Test methods

The physico-chemical properties, toxicity and ecotoxicity tests mentioned in this Annex should be performed following the basic principles of Good Laboratory Practices (GLP), according to GHS instructions. Although the international testing methods are preferred (OECD), national methods can also be used, if deemed equivalent. The referenced test methods mentioned in GHS and in ABNT NBR 14725-4 are shown in Table A.1. Table A.1 Test methods Tests Oral toxicity - LD50 - rats Dermal toxicity - LD50 - rats Inhalation toxicity LC50 - rats Skin corrosion/irritation test - rabbits or rats In vitro assays (Skin corrosion) Eye irritation/corrosion test - rabbits Skin sensitivity test, guinea pig Lethal mutation in rodents Translocation in mice Mammalian bone marrow chromosome aberration test Mouse spot test Micronucleus test Mammalian spermatogonial chromosome aberration test Liver DNA synthesis assay In vitro assays Carcinogenicity Reproductive toxicity test Screening test Target organ toxicity-repeated exposure test Fish toxicity: 96hr LC50 test Chronic toxicity test with fishes Acute toxicity test with Daphnia: 48hr, EC50 Toxicity test with algae Toxicity test with lemma Bioaccumulation test Biodegradation test Chronic toxicity test with Daphnia Toxicity test with marine algae Acute toxicity test with Mysidacea Chronic toxicity test with Mysidacea Acute toxicity test with marine fishes Chronic toxicity test with marine fishes Marine biodegradation tests Methods OECD 420, 423 e 425 OECD 402 OECD 403 OECD 404 OECD 430 e 431 OECD 405 OECD 406 e 429 OECD 478 OECD 485 OECD 475 OECD 484 OECD 474 OECD 483 OECD 486 OECD 473, 476 e 471 OECD 451 e 453 OECD 414, 415 e 416 OECD 421 e 422 OECD 408 OECD 203 OECD 210 e 212 OECD 202 OECD 201 OECD 221 OECD 305 OECD 301 OECD 211 OECD 201 OPPTS 8501035 OPPTS 8501350 OECD 203 OECD 210 e 212 OECD 306
General
Mutagenicity
Toxicology tests
Carcinogenicity Toxicity to reproduction and lactation Target organ toxicityrepeated exposure
Ecotoxicologic al tests on freshwater organisms
Ecotoxicologic tests: marine organisms
96
ABNT NBR 14725-2:2009

Table A.1 (continuing) Tests Self-heating Partition coefficient n-octanol/water Color Corrosivity Density of liquid and solids Burning rate Thermal stability Physical state Explosivity Boiling point temperature range PhysicoChemical Tests Flammability General Upper and lower explosion limits Odor pH Boiling point Flash point Melting point Vapor pressure and pressure at 20C Oxidizing properties Solubility with solvent(s) mixture Solubility in water Self-ignition temperature Decomposition temperature Methods VDI Guidelines 2263 OECD 107 ou 117 OPPTS8306302 ASTM G31-72 , OPPTS 8306320 OECD 109 EEC A17 OECD 104 OPPTS8306303 EEC A13 e EEC A14 OECD 103 ASTM D240, ISO 13943, ISO 10156, EEC A12 EEC A 14 OPPTS8306304 OPPTS87000, CIPAC MT75 OECD 103 ASTM D 3828-93,56-93, 3278-96, ISO 1516, EEC A9 OECD 102 OECD 104 OPPTS 8306314, EEC A17 OECD 105 EEC A6 EEC A15, CIPAC MT 84 OECD 113
97
ABNT NBR 14725-2:2009
Bibliography
[1] [2]
Decree 2657, of 03 of July of 1998, which publishes the Convention No 170 of the International Labour Organization (ILO) CIPAC (Collaborative International Pesticides Analytical Council). 1995. Handbook. Vol. F. Physico- Chemical Methods for Technical and formulated pesticide. Eds. W. DORAT and A.MARTIJN. Black Bear Press Ltda, Cambridge CB42PQ. England. 472pp. EEC (Economic European Community). Methods for the determination of physico-chemical properties, toxicity and ecotoxicity. Official Journal references. http://jrc.it/testing-methods/ OECD (Organization for Economic Cooperation and Development), Guidelines for Testing of Chemicals OPPTS Harmonized Guidelines. US.EPA (United States Environmental Protection Agency)
[3] [4] [5]
98
BRAZILIAN STANDARD
ABNT NBR 14725-3

Chemicals Information about safety, health and environment

Chemicals Information about safety, health and environment Part 3: Labeling
ABNT NBR 14725-3:2009
ABNT 2009
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written permission from ABNT.
ABNT NBR 14725-3:2009
Contents
Foreword v
Pgina
ABNT NBR 14725-3:2009

ABNT NBR 14725-3:2009
Foreword
The Brazilian Association of Technical Standards ABNT (Associao Brasileira de Normas Tcnicas) is the National Forum of Standardization. The Brazilian Standards, whose content is under the responsibility of the Brazilian Committees (ABNT/CB), Sectorial Standardization Organisms (ABNT/ONS) and Special Study Committees (ABNT/CEE), are worked out by Study Committees (CE) composed of representatives from the involved sectors, such as: Producers, consumers and neutral entities (universities, laboratories and others). The ABNT technical documentation is made according to the rules set forth in the ABNT Guidelines, Part 2. The Brazilian Association of Technical Standards (ABNT) emphasizes that some elements of this document may have patent protection. ABNT should not be held responsible to point out any patent rights. The Standard ABNT NBR 14725-3 has been worked out within the Brazilian Committee of Chemistry (ABNT/CB10) by members of the Committee for Information Studies on Safety, Health and Environment related to Chemicals (CE-10:101.05). Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-002, whereas the 2nd. Project was also sent to Nationwide Query through the Invitation to Bid no 09, carried out from 09/02/2008 until 10.01.2008 named 2nd for Project 10:101.05-002. ABNT NBR 14725-1 has been worked out within the Brazilian Committee of Chemistry (ABNT/CB-10) by members of the Committee for Information Studies on Safety, Health and Environment related to Chemicals (CE-10:101.05). Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-004, has been worked out within the Brazilian Committee of Chemistry (ABNT/CB-10) by members of the Committee for Information Studies on Safety, Health and Environment related to Chemicals (CE-10:101.05). Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-002.
The ABNT NBR 14725 standard entitled Chemical Products - Information on Safety, Health and Environment ("Produtos qumicos - Informaes sobre segurana, sade e meio ambiente") is expected to approach the following: Part 1: Terminology; Part 2: Hazard Rating System; Part 3: Labeling; Part 4: Material Safety Data Sheet (MSDS).
WARNING - Other classification systems, besides those described in this part of ABNT NBR 14725, may be used until 02.26.2011. After 02/27/2011, all chemicals should be classified only in accordance with this part of ABNT NBR 14725 (ABNT NBR 14725-3:2009). This ABNT NBR ABNT NBR 14725-3, jointly with Parts 2, 3 and 4, supersedes and cancel the ABNT NBR 14725:2005 print, which has been technically revised and dismembered in parts. This ABNT NBR 14725-3:2009 corrected print includes Errata 1 dated 01/26/2010.
ABNT NBR 14725-3:2009
Introduction
This ABNT NBR 14725 part was meant to set forth the criteria to include safety information in labels of hazardous chemical products (in accordance with the classification system), and additional legal requirements should be apply when labeling each type of product. ABNT NBR 14725 is part of the effort to implement the Globally Harmonized System (GHS) of information security on hazardous chemicals. Decree 2657 of July, 3rd, 1998, which issued the Convention No.170 of the International Labor Organization (ILO), establishes some responsibilities for the implementation of the ABNT NBR 14725 standard. Labeling hazardous chemical products is one out of several ways a supplier uses to transfer to the target public all essential information (including transport, handling, storage and emergency acts) about chemical products hazards. Focusing the obligations of the target public towards hazardous chemicals are beyond the scope of this ABNT NBR 14725 part. However, we have included some of them aiming at clearly establishing the difference between supplier obligations and target public obligations, as far as hazardous chemicals are concerned. ABNT NBR 14725 information on safety are included on the label of a hazardous chemical product, but it should be recognized that there are circumstances when demand and logic justify some flexibility regarding how appropriate is to include certain information for some specific target publics. This part of ABNT NBR 14725 also allows flexibility to adapt different ways to display, print or attach safety information on the packaging of dangerous chemicals. Target publics of interest for this part of ABNT NBR 14725 are employers and workers, consumers, and professionals working in emergency services and transport. This part of the ABNT NBR 14725 was based on the following GHS basic assumptions:
ABNT NBR 14725 was based on the following GHS basic assumptions: The need to provide information on hazardous chemicals related to safety, health and environment issues; The right of the target public become familiar and able to identify the dangerous chemicals commonly used and their associated risks; The utilization of a simple identification system, which could be easily understood and applied in the different sites where dangerous chemicals are used; The need to make this consistent system compatible with the classification criteria for all anticipated hazards by GHS; The need to facilitate international agreements and to protect industrial secrets and confidential information; The workers' training and skill building, and The development of consumers' education and awareness.
This Standard is not applicable to chemicals already manufactured and labeled before the enforcement of this Standard. Such products hold valid conditions until their expiration date as stated in each respective package.
ABNT NBR 14725-3:2009
BRAZILIAN STANDARD
ABNT NBR 14725-3:2009
Chemicals Information about safety, health and environment Part 3 Labeling
1 Scope
This ABNT NBR 14725 part defines the safety information concerning hazardous chemicals that should be included when labeling the product and does not establish a fix format.
The following documents are indispensable to the application of this Standard. Dated references are applicable only to the mentioned editions. For undated references, the latest reference should be applied (including amendments). ABNT NBR 7500, Identification for transportation, handling, movement and storage of materials ABNT NBR 14725-1, Chemicals Information about safety, health and environment Part 1: Terminology
ABNT NBR 14725-2, Chemicals Information about safety, health and environment Part 2: - Hazard Classification System ABNT NBR 14725-4, Chemicals Information about safety, health and environment Part 4: Material Safety Data Sheet - MSDS (Ficha de Informaes de Segurana de Produtos Qumicos FISPQ Brazil).

This part of ABNT NBR 14725, uses the terms and definitions of ABNT NBR 14725-1.
4 General considerations
4.1 The productive sectors already regulated with respect to labeling of chemicals must meet their specific legislation. 4.2 Whenever necessary the suppliers periodically should review the information in which the labeling and the Material Safety Data Sheet (MSDS) were being based for the substance or mixture. The MSDS is the medium used to update such information and Annex A provides the correlation between the labeling information of dangerous chemical and the MSDS (see ABNT NBR 14725-4). 4.3 Regarding the transfer of hazardous chemicals to other containers or equipment, employers should inform workers about the identification of such products (through codes, chemical names, trade names etc). Employers should provide all hazard information regarding chemicals handling, storage and transportation, besides all precautions and safety measures required based on the MSDS, whose availability should be assured by their management system.
ABNT NBR 14725-3:2009

4.4 As the labeling of a hazardous chemical is merely related to the product, it does not take into consideration all situations that may occur when a label is consulted. Therefore, the labeling of hazardous chemicals is only part of the information needed to design a program addressing the safety, health and environment. 4.5 The labeling of a hazardous chemical must meet this part of ABNT NBR 14725 at the time the hazardous chemical is about to be enclosed in its final packaging to be sold in the domestic market. 4.6 The labeling of a hazardous chemical should not have images or information that may mislead the targetpublic. 4.7 The text of hazardous chemicals labels should be brief, precise, and use simple meaningful words to minimize or avoid the risks from the normal use and storage of the product. 4.8 The supplier must check if the identification of the labeled hazardous chemical is correct, for it has the essential information to avoid safety, health and environmental risks. In the case of products packaged in the final packaging for sale, the supplier should consult the MSDS to update the information contained on the label of dangerous chemicals using his/her own criteria to adopt other measures deemed necessary. 4.9 It is the responsibility of the target public to respond according to a risk assessment, to follow the recommendations when using a hazardous chemical, and to take all necessary precautions regarding the associated relevant hazards. The target public is also responsible to preserve the information conveyed by the label of the hazardous chemical up to its appropriate final destination. 4.10 The conditions adopted for the protection of trade secrets should not compromise the health and the safety of workers or consumers, neither the protection of the environment. For this reason, the dangers associated with hazardous chemicals covered by these criteria must be disclosed on the label, even though the information about the composition of the hazardous chemical are not fully provided.
5 Safety information for the labeling hazardous chemicals

The label of a hazardous chemical should contain the following information (see Annex B): a) b) c) d) e) f) g) Product identification and supplier emergency telephone Chemical composition Hazard pictograms (see Annex C and D) Signal word (see Annex D) Hazard statement (see Annex D) Precautionary statement (see Annex E) Other information.
6 Product label specifications

NOTE Illustrative examples of labels are shown in Annex F.
ABNT NBR 14725-3:2009

6.1 The signal word(s), hazard statement(s), precautionary statement(s), and hazard pictogram(s) should be placed close to each other in the label of the hazardous chemical. The hazard pictograms may be included in the package itself of the hazardous chemical, close to the label and in the very same surface of the package. 6.2 The label format of a hazardous chemical is at supplier discretion.
6.3 The minimum size of letters for labels of dangerous chemicals should be designed to ensure clarity and legibility of the mandatory information, but letters smaller than 1 mm are not allowed. 6.4 The minimum size of the hazard pictogram should be 1 cm x 1 cm, except in the case of packages with dimensions where the room available only admits smaller labels. Safety pictograms can be used with a minimum size of 1 cm x 1 cm or a minimum diameter of 1 cm, except in the case of packages with dimensions where the room available only admits smaller labels. 6.5 The label of a hazardous chemical should be made of a material that will withstand normal use, transport and storage within the validity period of the product. 6.6 All security information in the label of a hazardous chemical must be written in Portuguese (Brazil).
6.7 There are no restrictions on concurrent use of other languages on labels of dangerous chemicals. In the case of export of dangerous chemicals: The inner packaging may contain label in another language, provided that its respective outer packaging meets the requirements of this part of ABNT NBR 14725; Simple packaging must be labeled according to the requirements of this part of ABNT NBR 14725, and Overwrapping must be labeled according to the requirements of this part of ABNT NBR 14725, but the label on the contained package should not be visible. If visible, it should comply with this part of ABNT NBR 14725.
6.8 Import operations do not require compliance with the requirements of this part of ABNT NBR 14725 for dangerous chemical labels until the delivering to the importer. 6.9 Pictograms must be posted on a background of contrasting color.
6.10 Alternative means can be used to provide workers with safety information on labels of hazardous chemicals in the workplace, provided that such methods ensure clear communication of danger and that workers are properly trained.
ABNT NBR 14725-3:2009

Anexo A (informativo) Correlao entre as informaes da FISPQ e da rotulagem de produto qumico perigoso
Annex A (informative) Correlation between the information in FISPQ sheets and the labeling of the hazardous chemical
Label elements Product identification and supplier emergency telephone Chemical composition Hazard pictograms Signal word Hazard statement Precautionay statements Other information Correlation with FISPQ sections Section 1 - Product and company identifications Section 3 - Composition and information on ingredients Section 2 - Hazard identification Section 14 Transport information Section 2 - Hazards awareness Section 2 - Hazard awareness Section 2 - Hazard awereness Any other information available in the FISPQ and still not mentioned
ABNT NBR 14725-3:2009

Anexo B (normativo) Instrues para incluso das informaes de segurana no rtulo do produto qumico perigoso
Annex B (normative) Instructions on how to include safety information in the label of hazardous chemicals
NOTE The directives provided by this Annex deal with the preparation of security labels for hazardous chemicals. The instructions aiming at ensuring that the content of the information enable the product receivers to take the essential steps to deal with risks, safety, health protection in the workplace and for the environment.
B.1 Product identification and supplier emergency telephone

The product label of the hazardous chemical should contain the trade name and the technical name of the product as used in the MSDS. The product label of the hazardous chemical should contain the supplier emergency phone number(s). The emergency phone number(s) should provide support for emergency situations, providing safety, health (including toxicological), and environmental information.
B.2 Chemical composition

The product label of the hazardous chemical should contain the name(s) of the ingredient(s) contributing in making the substance or mixture hazardous through its common chemical or generic name. To ingredients or impurities contributing to the hazardous nature of the chemical should comply with the limits set in ABNT NBR 14725-2. If any ingredient that contributes to make the chemical hazardous is a trade secret in accordance with the relevant regulations, the supplier will be free from the obligation to inform such ingredient on the label of the hazardous chemical and should attend to what is described in 4.10.
B.3 Hazard pictograms

The hazardous nature of the chemical product(s) should be informed on the label through its hazard pictograms (see Annex D). The symbols used in these pictograms should comply with Annex C. The variation in design and pictograms should be prepared according to ABNT NBR 7500. Such pictograms should consist of a black symbol on a white background and red border. The edge can be in black if the pictogram is used in containers not intended for export. If dangerous chemical has the same hazard identification assigned to transport, only the pictogram (risk label) of transport may be used on the outer package so that duplication is avoided (see Figure F.1). Hazard pictograms presented in this part of ABNT NBR 14725 should be placed in the inner container (see Figure F.2). The following priority criteria should be applied to health hazards: a) When required to use two pictograms for the same class of hazard, only the higher hazard category should be used. For example, in a acute toxicity case, when using the pictogram of categories 1, 2 or 3 (skull and crossbones), a category 4 (exclamation point) pictogram of this same hazard class should not be used;
ABNT NBR 14725-3:2009

b) c) If the pictogram of the hazard class category 1 for respiratory sensitivity is adopted, the pictogram of category 1 of the hazard class awareness to the skin (exclamation point), if applicable, should not be employed; A pictogram should be used only once if two hazard classes require the adoption of the same pictogram. For example, a mixture having an ingredient category 2A of the eye irritation class and another category 4 of the class of acute toxicity, the exclamation point pictogram should be used only once.
B.4 Signal words

Signal words means a word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label. "Danger and Warning are used as signal words. The first is used for the more severe hazard categories, while the second is used for the less severe according to ABNT NBR 14725-2. Signal words, when used, should be included in the labeling of the hazardous chemical, as provided in Annex D.
B.5 Hazard statement

Hazard statements are standardized texts and should be included in the label of the hazardous chemical according to Annex D.
B.6 Precautionary statements

The applicable precautionary statements should be included on the label of dangerous chemical and include information on: Physical hazard; How to avoid potential misuse and exposure to health Applications in cases of accidents with the product and how to protect the environment Suitable methods for disposal.
Annex E provides some examples of precautionary statements that can be used depending on the characteristics of the hazardous chemical
B.7 Other information

The label of a hazardous chemical must contain the following sentence: "The Material Safety Data Sheet for Chemical Products of this hazardous chemical can be obtained through". Other relevant safety information on hazardous chemicals may be provided if not hindering the clear identification of the information included in this part of ABNT NBR 14725.
ABNT NBR 14725-3:2009

Anexo C (normativo) Smbolos de perigo
Annex C (normative) Hazard symbols

Hazard symbol Name
Exploding bomb
Flame
Flame over circle
Gas cylinder
Corrosion
Skull and crossbones
Exclamation point
Health hazard
Environment
ABNT NBR 14725-3:2009

Anexo D (normativo) Pictogramas de perigo, palavras de advertncia e frases de perigo
Annex D (normative) Hazard pictograms, signal word and hazard statements

This Annex presents the hazard pictograms, signal words and hazard statements that should be included on the label of a hazardous chemical according to its own hazard identification (see Tables D.1 to D.31). The hazard statements should stay as presented in this Annex, they should not be modified or merged. Table D.1 Explosives
Explosive type Unstable explosives Division 1.1 Division 1.2 Division 1.3 Division 1.4 Division 1.5 Division 1.6
Pictogram
Signal word
Danger
Danger
Danger
Danger
Warning
Danger
Hazard statement
Unstable explosive
Explosive; mass explosion hazard
Explosive; severe projection hazard
Explosive; fire, blast or projection hazard
Fire or projection hazard
Mass can explode in fire
Table D.2 Flammable gases

Category 1 2
Pictogram
Signal word
Danger Extremely flammable gas
Warning
Hazard statement
Flammable gas
ABNT NBR 14725-3:2009

Table D.3 Flammable aerosols Category 1 2
Pictogram
Signal word Hazard statement
Danger Extremely flammable aerosol
Warning Flammable aerosol
Table D.4 Oxidizing gases Category 1
Pictogram
Signal word
Danger Can cause serious fire; oxidizer
Hazard statement
Gas
Table D.5 Gases under pressure Compressed gas Liquefied gas Refrigerated gas
Dissolved gas
Pictogram
Signal word
Warning
Warning
Warning
Warning
Contains Contains Contains Contains refrigerated gas; refrigerated gas; gas under gas under Hazard statement can cause can cause pressure; can pressure; can cryogenic burns cryogenic burns explode if heated explode if heated or injury or injury
ABNT NBR 14725-3:2009

Category Table D.6 Flammable liquids 1 2 3 4
Pictogram
Signal word
Danger
Danger Highly flammable liquid and vapor
Warning Flammable liquid and vapor
Warning Combustible liquid
Extremely Hazard statement flammable liquid and vapor
Table D.7 Flammable solids Category 1
Pictogram
Danger Flammable solid matter
Warning Flammable solid matter
Table D.8 Self-reactive substances and mixtures Type A B C and D E and F G
Pictogram There are no label elements allocated to this hazard category Signal word Danger Can explode if heated Danger Can explode or become flammable if heated Danger Can become flammable if heated Warning May become flammable if heated
Hazard statement
10
ABNT NBR 14725-3:2009

Table D.9 Pyrophoric liquids Category 1
Pictogram
Danger Ignites immediately in contact with air
Table D.10 Pyrophoric Solids Category 1
Pictogram
Danger Ignites immediately in contact with air
Table D.11 Self-heating substances and mixtures Category 1 2
Pictogram
Danger Self-heated matter; can ignite
Warning Self-heated matter in large quantities; may ignite
11
ABNT NBR 14725-3:2009

Table D.12 Substances and mixtures that emit flammable gases in contact with water Category 1 2 3
Pictogram
Signal word
Danger In contact with water releases flammable gases which may ignite spontaneously
Danger In contact with water releases flammable gases
Warning In contact with water may release flammable gases
Hazard statement
Category
Table D.13 Oxidizing liquids 1 2
Pictogram
Signal word
Danger Can cause fire or explosion; strong oxidizer
Danger
Warning
Hazard statement
Can intensify fire; oxidizer
May intensify fire; oxidizer
Category
Table D.14 Oxidizing solids 1 2
Pictogram
Signal word
Danger Can cause fire or explosion; strong oxidizer
Danger
Warning
Hazard statement
Can intensify fire; oxidizer
May intensify fire; oxidizer
12
ABNT NBR 14725-3:2009

Type A Table D.15 Organic peroxides B C and D E and F G
Pictogram There are no label elements allocated to this hazard category Signal word Hazard statement Danger Heating can cause an explosion Danger Heating can cause a fire or explosion Danger Can ignite if heated Warning May ignite if heated
Table D.16 Corrosive to metals Category 1
Pictogram
Warning May be corrosive to metals
Category
Table D.17 Acute toxicity - Oral 2 3
Pictogram
Danger Fatal if swallowed
Danger Fatal if swallowed
Danger Toxic if swallowed
Warning Harmful if swallowed
Warning May be harmful if swallowed
13
ABNT NBR 14725-3:2009

Table D.18 Acute toxicity - Skin 2 3
Category
Pictogram
Danger Fatal in contact with skin
Danger Fatal in contact with skin
Danger Toxic in contact with skin
Warning Harmful in contact with skin
Warning May be harmful in contact with skin
Table D.19 Acute toxicity - Inhalation Categoria 1 2 3 4 5
Pictogram
Danger Fatal if inhaled
Danger Fatal if inhaled
Danger Toxic if inhaled
Warning Harmful if inhaled
Warning May be harmful if inhaled
Table D.20 Skin corrosive/Irritant Category 1A 1B 1C 2 3
Pictogram
Danger Causes severe skin burns and eye damage
Warning Causes skin irritation
Warning Causes mild skin irritation
14
ABNT NBR 14725-3:2009

Table D.21 Serious eye damage/eye irritation Categoria 1 2A 2B
Pictogram
Danger Causes serious eye damage
Warning Causes serious eye irritation
Warning Causes eye irritation
Table D.22 Respiratory sensitization Category 1
Pictogram
Signal word
Danger When inhalated may cause alergic syntoms, asthma or breathing difficulties
Hazard statement
Table D.23 Skin sensitization Category 1
Pictogram
Warning May cause skin alergy
15
ABNT NBR 14725-3:2009

Table D.24 Mutagenicity Category 1A 1B 2
Pictogram
Signal word
Danger
Danger Can cause genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
Warning Suspected of causing genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
Hazard statement
Can cause genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
Table D.25 Carcinogenicity Category 1A 1B 2
Pictogram
Signal word
Danger Can cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard )
Danger Can cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard )
Warning Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
Hazard statement
16
ABNT NBR 14725-3:2009

Table D.26 Toxic to reproduction Category 1A 1B 2 Additional Category on effects on or via lactation
Pictogram
Signal word
Danger Can damage fertility or the unborn child (state specific effect if known) if(state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard )
Danger Can damage fertility or the unborn child (state specific effect if known) if(state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard )
Warning
Hazard statement
Suspected of damaging fertility or the unborn child (state specific effect if known) if(state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
May cause harm to breast-fed children.
Table D.27 Specific target organ systemic toxicity (single exposure) Category 1 2 3
Pictogram
Signal word
Danger
Warning
Warning
Hazard statement
Causes damage to organs (state all organs affected, if known) if (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
May cause damage to organs (state all organs affected, if known) if (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
May cause respiratory irritation (respiratory tract irritation) or May cause drowsiness and dizziness (Narcotic effects)
17
ABNT NBR 14725-3:2009

Table D.28 Specific target organ systemic toxicity (repeated exposure) Category 1 2
Pictogram
Signal word
Danger Causes damage to organs (state all organs affected, if known) through prolonged or repeated exposure (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
Warning May cause damage to organs (state all organs affected, if known) through prolonged or repeated exposure (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
Hazard statement
Table D.29 Aspiration hazard Category 1 2
Pictogram
Danger Can be fatal if swallowed and enters airways
Warning May be harmful if swallowed and enters airways
18
ABNT NBR 14725-3:2009

Table D.30 Hazard to aquatic environment Category 1 2 3
Pictogram
Warning Very toxic to aquatic life
Toxic to aquatic life
Harzardous to aquatic life
Table D.31 Aquatic toxicity (chronic) Category 1 2 3 4
Pictogram
Signal word
Danger Very toxic to aquatic life, with prolonged effects
Toxic to aquatic life, with prolonged effects
Harmful to aquatic life, with prolonged effects
May cause long lasting harmful effects to aquatic life
Hazard statement
19
ABNT NBR 14725-3:2009

Anexo E (informativo) Frases de precauo
Annex E (informative) Precautionary statements

This annex lists the preventive information frequently used in labeling (see Tables E.1 to E.4). This list was designed to expose examples of information that may be appropriate for certain labels for a specific substance or mixture. Suppliers can make use of those phrases they may consider most appropriate for each particular situation, taking into account the hazard(s) defined indicated by the product classification. When a sentence contains words in brackets, any word within brackets in the sentence may be used in addition to the core information given.[Keep away from fire] or [Keep away from heat and sparks] or [Keep away from sparks and or flames], etc. Likewise, phrases of different groups can be used in combination, for example: [Keep away from heat and ignition sources and store in a cool and well-ventilated place]. NOTE It should be taken into consideration the experience of professionals related to the specific areas used to employ such precautionary statements.
20
ABNT NBR 14725-3:2009

Table E.1 Physical hazard statements Keep away from fire [No smoking] Keep away from heat [sparks] [and open flame] [No smoking] Keep away from heat and ignition sources [No smoking] Avoid heat and ignition sources [and oxidizers] [No smoking] Ignition sources precautions Do not produce open flames or sparks and do not smoke Take preventive measures against static charges Use only non-sparking tools Keep away from direct sun light Keep away from flames and hot surfaces Do not use or store near heat or flames Use explosion-proof ventilating and lighting equipment Keep container closed Container precautions Keep container closed when not using Store container tightly Keep only in the original container Store in a cool place Liquids, solids and flammable gases Store in cool place at temperature not exceeding ...C Decomposes below the boiling point atC Decomposes below the melting point atC Keep container/package in well-ventilated place Keep container/package tightly closed in a cool place [well -ventilated] Storage of containers or packings Keep container/package only in original packing, in a cool and well-ventilated place Store in a cool place/low temperature, well ventilated [dry] [away from heat and ignition sources] Suitable materials for packaging the product (storage and/or transport) are listed in FISPQ. Range/limit of explosivity May cause explosion if exposed at temperatures of about... C Store away from incompatible material Do not store and/or transport with oxidizers [flammable] [corrosives] [oxygen] [explosives] [halogens] [compressed air] [acids] [bases] [intended additive] [etc] Firefighting Liquid and pyrophoric solids of spontaneous ignition a Self-heating substances b Use CO2, dry chemical or foam In case of fire, use [...]
Keep in inert media (include name of inert media) Do not allow contact with air Protect from light, moisture and damage Keep at a temperature not exceeding ... C
21
ABNT NBR 14725-3:2009

Table E.1 (continuing) Keep away from water Keep recipient dry Never add water to this product Substances and mixtures that emit flammable gases in contact with water a No contact with water Do not add water to contents while in a container because of violent reaction and possible spark. Store in a dry place Protect from moisture and damage Handle in inert atmosphere (insert name of inert gas) Protect from moisture Mantenha afastado de material combustvel Keep away from (insert the name of incompatible material) Keep from contact with clothing and other combustible materials to avoid fire Prevent contamination with readily oxidizable materials and polymerization accelerators Liquids, solids and oxidizer gasesc Do not store near combustible materials Drying of this product on clothing or combustible materials may cause fire Put safety caps and shockproof rubber rings on cylinders in transport Do not store and transport with flammable/combustible materials etc Isolate from reducers and flammable/ combustible materials etc in storage
Do not store and transport with halogens and acids, etc. Separate from reducers and finely powdered metals in storage and transport. Keep away from combustible material Keep away from (insert the name of incompatible material) Keep from contact with clothing and other combustible materials to avoid fire Prevent contamination with readily oxidizable materials and polymerization accelerators Do not store near combustible materials Organic peroxides
c
Drying of this product on clothing or combustible materials may cause fire Put safety caps and shockproof rubber rings on cylinders in transport Do not store and transport with flammable/combustible materials etc Isolate from reducers and flammable/ combustible materials etc in storage Do not store and transport with halogens and acids, etc Separate from reducers and finely powdered metals in storage and transport Keep away from chemicals specified by the manufacturer [relevant authority]
22
ABNT NBR 14725-3:2009

Table E.1 (continuing) Keep away from heat Store at temperature not exceeding ...C Keep away from heat. Keep away from heat [sparks] [flame] Keep away from heat and ignition sources Keep away from ignition sources Avoid heat and ignition sources Do not produce open flames or sparks and do not smoke Self-reacting substances Keep away from combustible material Keep away from (incompatible material to be specified by manufacturer) Keep from contact with clothing and other combustible materials to avoid fire Prevent contamination with readily oxidizable materials and polymerization accelerators Do not store near combustible materials Drying of this product on clothing or combustible materials may cause fire Put safety caps and shockproof rubber rings on cylinders in transport Do not store and transport with flammable/combustible materials etc. Avoid shock [impact], [friction], [and rough handling] Keep away from fire Do not produce open flames or sparks and do not smoke
Explosive vapor/air mixtures may be formed above... C Gas/air or vapor/air mixtures are explosive Explosives d Finely dispersed particles form explosive mixtures with air Do not use compressed air for filling, discharging or handling Corrosive to metal (insert name of metal/alloy) Suitable materials for containment (storage and transport) are listed in the FISPQ Avoid contact with skin and eyes
a b
Use phrases with any combination of the phrases "Liquids, solids and flammable gases". Use phrases with any combination of the phrases "Liquids, solids and flammable gases", regarding the "Containment and storage of the container or package", relating to store separately from incompatible materials. Use phrases with any combination of the phrases "Liquids, solids and flammable gases", regarding the "Containment and storage of the container or package", as appropriate. Use phrases with any combination of the phrases "Liquids, solids and flammable gases", regarding "Precautions against sources of ignition".
23
ABNT NBR 14725-3:2009

Table E.2 Statements to prevent potential misuse and exposure to health Use only in ventilated areas Use only with adequate ventilation [or closed system ventilation] Do not enter areas where used or stored until adequately ventilated Use only with adequate ventilation to keep exposures (airborne levels of dust, fume, vapor etc) below recommended exposure limits. Use adequate ventilation to remove vapors (fumes, dust etc). Use adequate ventilation and/or engineering controls in high Ventilation controls temperature processing to prevent exposure to vapors Prevent vapor build up by providing adequate ventilation during and after use [Use with] [ventilation], local exhaust ventilation [or breathing protection] Do not use in areas without adequate ventilation Never breath dust, vapor or mist When using do not [smoke] [eat] [or drink] Do not eat, drink or smoke during work Wash hands before eating [drinking] [or smoking] Wash thoroughly after handling Avoid direct contact Avoid contact with [skin] [skin and eyes] [clothing] Wash thoroughly with soap and water after handling Hygiene measures Wash thoroughly with soap and water after handling before eating, drinking, or smoking Keep out of reach of children and domestic pets Before using, read carefully the label instructions Product is strictly for professional use Keep only in the original container Do not reuse empty packages Wear protective clothing (specify protective clothing) Wear protective gloves (specify protective gloves) Wear protective eyewear (specify type of protection) Personal protection equipment (PPE) Wear appropriate personal protective equipment (specify type of personal protective equipment) Avoid direct contact In case of insufficient ventilation, wear suitable respiratory equipment (specify type of respiratory protective equipment) During fumigation/spraying, wear suitable respiratory equipment (specify type of respiratory protective equipment) Respiratory protective equipment Always wear a self-contained breathing apparatus or full-face airline respirator when using this chemical Wear a mask or pesticide respirator jointly approved by the relevant authorities
24
ABNT NBR 14725-3:2009

Table E.3 Statements explaining appropriate action in the event of an accident In event of a spill, evacuate danger area In event of a spill, consult an expert To clean the floor and all objects contaminated by this material, use (specify material) Cover [Contain] the spilled material with Collect the spilled material and mark it for final disposal Absorb remaining liquid with (specify material) Treat remaining liquid with (specify material) Do not wash away into sewer Avoid run off to waterways and sewers Spills Allow product to cool/solidify and pick up as a solid Sweep up and remove immediately Use non-sparking equipment when picking up flammable spill, [remove all ignition sources] Use adequate ventilation to remove vapors (fumes, dust etc) Collect leaking liquid in containers (specify type of container) Cautiously neutralize spilled liquid with (specify neutralizer) Vacuum spilled material Sweep spilled substances into containers (specify type of container) Do not absorb in saw-dust or other combustible absorbents Never direct water jet on liquid In case of fire use ... (specify type of firefighting equipment to be used) Never use water because it increases the risks
Use CO2, dry chemical, or foam Firefighting Water can be used to cool and protect exposed material Allow gas to burn if flow cannot be shut off Shut off supply Let the fire burn itself out General In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible) Have the product container or label with you when calling a poison control center or doctor, or going for treatment In case of accident by inhalation, remove casualty to fresh air and keep at rest [get medical attention immediately] If inhaled, get medical attention immediately First-aid measures If signs/symptoms continue, get medical attention Accident caused by inhalation If breathing has stopped, apply artificial respiration under medical advice If breathing is labored, administer oxygen under medical advice If inahaled, give oxygen or artificial respiration and look for medical services If inhaled, give (specify antidote) and get medical attention If person has breathing difficulties, call emergency telephone numberand get medical attention Call a poison control centre or doctor for further treatment advice
25
ABNT NBR 14725-3:2009

Table E.3 (continuing) Obtain medical attention immediately if ingested If swallowed, do not induce vomiting: seek medical advice immediately and show the container or label If swallowed, seek medical advice immediately and show the container or label If swallowed, rinse mouth with water [only if the person is conscious] Accident caused by ingestion [Do not induce vomiting] [If conscious, give two glasses of water. Get immediate medical attention] Drink [one glass] [two glasses] of water. Call a physician [or poison control center] immediately Rinse mouth Never induce vomiting Give nothing to drink Let the person rest and give and give plenty of water to drink If ingested, call control center or doctor immediately for treatment advice Do not give anything by mouth to an unconscious person After contact with skin, take off immediately all contaminated clothing and wash immediately with plenty of... [If irritation develops and persists, get medical attention] If irritation develops, get medical attention First-aid measures Accident caused by skin contact Immediately wash with mild soap in flowing water for 15 minutes. Flush skin with large amounts of water. [If irritation develops and persists, get medical attention] Immediately flush skin with large amounts of water. Remove contaminated clothing. If irritation [redness, rash, blistering] develops, get medical attention Wash contaminated clothing before reuse Remove contaminated clothing and wash clothing before reuse Remove contaminated clothing and wash clothing before reuse. Flush the contaminated area of body with large amounts of water Wash the contaminated area of body with soap and fresh water If contact occurs with body directly, immediately obtain medical attention Flush with fresh water if contact with skin or eyes Take off contaminated clothing Rinse skin immediately with plenty of water for 15-20 minutes In case of contact with eyes rinse immediately with plenty of [to be specified by manufacturer] Immediately flush eyes for at least 15 minutes. Get medical attention Accident caused by contact with eyes Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. Get medical attention Flush eyes with water for at least 15 minutes while holding eyelids open Remove contact lenses if worn. Get medical attention immediately First rinse with plenty of water for several minutes. Remove contact lenses if easily possible. Get medical attention If contact with eyes directly, flush with gently flowing fresh water thoroughly
26
ABNT NBR 14725-3:2009

Table E.4 Statements for environmental protection and appropriate disposal Use appropriate containment to avoid environmental contamination Avoid release to the environment Do not let this chemical/product enter the environment. Environmental protection Do not release directly in water courses This chemical is known to leach through soil into ground water under certain conditions Do not allow contact with water courses or sewage Dispose of this container to hazardous or special waste collection point Dispose of this material and its container as hazardous waste Do not dispose of with household waste, trash or other solid waste Dispose of wastes in an approved landfill duly licensed by the relevant authorities Information on final This material and its container must be disposed of in a safe way disposall For queries about recovery/recycling, waste disposal of this product or contaminated packaging, consult/contact [specify information source/contact] The recommended waste management options for this product are [reuse] [recycling] [incineration] [disposal in industrial landfill] [etc]
27
ABNT NBR 14725-3:2009

Anexo F (informativo) Exemplos ilustrativos de rtulos
Anexo F (informative) Illustrative examples of labels

NOTE This Annex provides examples of the GHS information on labels of hazardous chemicals. These examples do not encompass all information required by other regulations.
F.1 Combination packaging for a Category 2 flammable liquid
UM 1993 UM 1993 Flammable liquid Lquido inflamvel Trade name and Nome comercial technical name e nome tcnico
TRADE NAME AND NOME COMERCIAL E TECHNICAL NAME NOME TCNICO

Chemical composition; See B.3 Composio qumica, ver B.3
Product identification and supplier's Indicao do produto e telefone emergency telephone (See B.1 and B.2)
de emergncia, ver B.1 e B.2
Signal word; See Annex D Palavra de advertncia, ver Anexo D Hazard statement; See Annex D Hazard statement, ver Anexo D Precautionary statement; See Annex E Frase de precauo, ver Anexo E
"The Material Safety Data Sheet for Chemical Products of this Sheet for Chemical Products of this "The Material Safety Datade Segurana de Produtos Qumicos deste A ficha de informaes hazardous chemical can be obtained through" hazardous chemical can bepode ser obtida por meio de ... produto qumico perigoso obtained through"
NOTE
The proper hazard pictogram required for product classification, indicated in Annex D, can also be inserted
Figure F.1 Outer packaging: Box with transport label for flammable liquid (Risk Class 3) (see ABNT NBR 7500)
28
ABNT NBR 14725-3:2009
TRADE NAME AND TECHNICAL NAME
Product identification and supplier's emergency telephone, see B1 and B2 Signal word, see Annex D Hazard statement, see Annex D Precautionary Statement, see Annex E
Chemical composition, see B.3
"The Material Safety Data Sheet for Chemical Products of this hazardous chemical can be obtained through
Figure F.2 Inner packaging: flammable liquid glass bottle with GHS label (Category 2) (see 5.1)
29
ABNT NBR 14725-3:2009
F.2 Inner packaging: Category 2 flammable liquid and Category 2 skin irritant
UN 1993 Flammable liquid Tradename and Technical name

Chemical composition; See B.3
Product identification and supplier's emergency telephone (See B.1 and B.2)
Signal word; See Annex D
Hazard statement; See Annex D
Precautionary statement; See Annex E "The Material Safety Data Sheet for Chemical Products of this hazardous chemical can be obtained through"
NOTE
Hazard pictograms are shown in Annex D
Figure F.3 Inner packaging: 200 L drum with GHS label and transport label
30
ABNT NBR 14725-3:2009
F.3 Overwrapping with two combined packages: one with flammable liquid Category 2 and another containing a skin irritant Category 2

Chemical composition; See B.3 UM 1993 Flammable liquid Trade name and technical name
Product identification and supplier's emergency telephone (B.1 and B.2) Signal word; See Annex D Hazard statement; See Annex D Precautionary statement; See Annex E
Label 1
"The Material Safety Data Sheet for Chemical Products of this hazardous chemical can be obtained through"

Product identification and supplier's Chemical composition; See B.3 emergency telephone (B.1 and B.2) Signal word; See Annex D Hazard statement; See Annex D Precautionary statement; See Annex E
Label 2
NOTE
Boxes A and B are inside box C
Figure F.4 Overwrapping: cardboard box with GHS label and transport label
31
ABNT NBR 14725-3:2009
F.4 Product label

Chemical composition Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)
32
Use only in ventilated sd areas Keep away from fire, sparks and heated surfaces - Do not smoke Keep recipient tightly closed Read label before using Keep out of the reach of children Precautionary statements:
Danger
May be hazardous to kidneys and liver through prolonged Harmful if inhaled Highly flammable liquid and vapors Hazard statements: and repeated exposure
ABNT NBR 14725-3:2009
33
ABNT NBR 14725-3:2009
NOTE The information on this hazardous chemicals label pertains only to this section of ABNT NBR 14725 Figure F.5 Product classified as Category 2 flammable liquid, acute inhalation toxicity category 4 and systemic toxicity through repeated exposure category 2 to the target organ
34
Emergency telephone
Technical name
Trade name
ABNT NBR 14725-3:2009
Bibliography
[1] [2] [3] Decree 2657, of 03 of July of 1998, which publishes the Convention No 170 of the International Labour Organization (ILO) GHS book, Globally Harmonized System of Classification and Labeling of Chemicals (GHS) - Purple Book, 2005 SANS 10234:2007, Globally Harmonized System of classification and labeling of chemicals (GHS) - South African Standard
35
BRAZILIAN STANDARD
ABNT NBR 14725-4

Chemicals Information about safety, health and environment Part 4: Ficha de informaes de segurana de produtos qumicos (FISPQ)
Chemicals Information about safety, health and environment Part 4: Safety data sheet for chemicals (SDS)
ICS 71.100.01 BRAZILIAN ASSOCIATION TECHNICAL STANDARDS
ISBN 978-85-07-01706-6 Nmero de referncia ABNT NBR 14725-4:2009 21 pginas ABNT 2009
ABNT NBR 14725-4:2009
ABNT 2009
All rights reserved.. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written permission from ABNT.
ABNT NBR 14725-4:2009
Contents
Foreword v
Pgina
ABNT NBR 14725-4:2009

ABNT NBR 14725-4:2009
Foreword
The Brazilian Association of Technical Standards ABNT (Associao Brasileira de Normas Tcnicas) is the National Forum of Standardization. The Brazilian Standards, whose content is under the responsibility of the Brazilian Committees (ABNT/CB), Sectorial Standardization Organisms (ABNT/ONS) and Special Study Committees (ABNT/CEE), are worked out by Study Committees (CE) composed of representatives from the involved sectors, such as: Producers, consumers and neutral entities (universities, laboratories and others). The ABNT technical documentation is made according to the rules set forth in the ABNT Guidelines, Part 2. The Brazilian Association of Technical Standards (ABNT) emphasizes that some elements of this document may have patent protection. ABNT should not be held responsible to point out any patent rights. Their 1st Project was sent to a Nationwide Query according to the Invitation to Bid no. 12, carried out from 12/21/2007 until 02/18/2008, with the Project number 10:101.05-005, whereas the 2nd. Project was also sent to Nationwide Query through the Invitation to Bid no 09, carried out from 09/02/2008 until 10.01.2008 named 2nd for Project 10:101.05-005. The ABNT NBR 14725 standard entitled Chemical Products - Information on Safety, Health and Environment ("Produtos qumicos - Informaes sobre segurana, sade e meio ambiente") is expected to approach the following:: Part 1: Terminology; Part 2: Hazard Classification System; Part 3: Labeling; Part 4: Material Safety Data Sheet - MSDS.
WARNING - the Material Safety Data Sheet - MSDS can be in agreement with the previous edition of this Standard (ABNT NBR 14725:2005) until 02.20.2011. From 02.27.2011, they must comply only with this issue (ABNT NBR 14725-4:2009. This ABNT NBR 14725-4 first edition, jointly with Parts 1, 2 and 3, supersedes and cancel the ABNT NBR 14725:2005 print, which has been technically revised and dismembered in parts. This ABNT NBR 14725-4:2009 corrected print includes Errata 1 dated 01/26/2010.
ABNT NBR 14725-4:2009
Introduction
The information document security (MSDS) provides information on various aspects of chemical substances (or mixtures) in the protection, safety, health and to the environment. Under such perspectives, MSDS provides the basic knowledge about chemicals, recommendations on protective measures, and actions in emergency situations. In some countries, this sheet is known as Safety Data Sheet (SDS). Along this part of ABNT NBR 14725, FISPQ is the term used for MSDS. The FISPQ is also known as Sheet of/with Safety Data (FDS). The FISPQ is a way for the supplier to transfer essential information to the user about the dangers of a chemical (including information on transportation, handling, storage and emergency action), giving him/her the chance to take the necessary measures related to safety, health and environment. The FISPQ can also be used to transfer these information to workers, employers, health and safety professionals, emergency personnel, government agencies, and community members as well, besides institutions, services and other parties involved with the chemicals. This part of ABNT NBR 14725 establishes the conditions to create consistency in providing information on security issues, health and environment related to chemicals. Certain requirements have been defined aiming at establishing uniformity on how the product information should be presented (eg, terminology, and the numbering sequence of the sections). This part of ABNT NBR 14725 is flexible to be adapted to the several editing and publishing systems to transmit the text. Focusing the obligations of FISPQ towards hazardous chemicals are beyond the scope of this part of ABNT NBR 14725. However, we have included some of them aiming at clearly establishing the difference between the obligations of FISPQ supplier and the duties of the FISPQ user.
ABNT NBR 14725 is part of the effort to implement the Globally Harmonized System (GHS) of information security on hazardous chemicals. Decree 2657 of July, 3rd, 1998, which issued the Convention No.170 of the International Labour Organization (ILO) establishes some responsibilities for the implementation of the ABNT NBR 14725 standard. The preparation of the ABNT NBR 14725 was based on the following basic assumptions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS): There is a need to provide information on hazardous chemicals concerning safety, health and environment; The target public has the right to know and identify the hazardous chemicals they use and the dangers they offer; A simple and easy to understand system of identification should be applied in the different locations where the hazardous chemicals are used; Such system should be compatible with the classification criteria for all hazards that might be anticipated by GHS; International agreements should be facilitated and industrial secrets and confidential information should be protected; There is a need to train workers and to improve their capability and It is required to foster users' education and awareness.
ABNT NBR 14725-4:2009
BRAZILIAN STANDARD
ABNT NBR 14725-4:2009
Chemicals Information about safety, health and environment Part 4: Material Safety Data Sheet (FISPQ)
1 Scope
This part of ABNT NBR 14725 has information related to the preparation of sheets about the safety of chemicals (MSDS). This part of ABNT NBR 14725 particularity defines: The FISPQ general presentation model; The 16 mandatory sections of a FISPQ; The numbered order and the sequence in which the FISPQ is presented; The FISPQ information to be filled out and how they should be applied and used.
This part of ABNT NBR 14725 does not define a FISPQ fix format.
The following documents are indispensable to the application of this Standard. Dated references are applicable only to the mentioned editions. For undated references, the latest reference should be applied (including amendments). Approval of the Metrological Regulation of Units of Measurement, (Conmetro Resolution 11 of 10.12.1988) Adoption of the General Table of Measurement Units and Use of the International Unit System - SI (Conmetro Resolution 12 of 10.12.1988) ABNT NBR 14725-1, Chemicals Information about safety, health and environment Part 1: Terminology ABNT NBR 14725-2, Chemicals Information about safety, health and environment Part 2: Hazard Classification System

The terms and definitions of ABNT NBR 14725-1 are relevant for this part of ABNT NBR 14725.
4 General considerations
The FISPQ should be applied as a whole to the chemical product.
ABNT NBR 14725-4:2009

The FISPQ is not a confidential document. It is not necessary to inform the full composition of the chemical, but aiming at not compromise the health and safety of users, and to protect the environment, all information concerning to establish the safe use of a substance or mixture, no matter how confidential such information might be, should be provided. The conditions adopted for the protection of trade secrets should not compromise the health and the safety of workers or consumers, or the environmental protection. For this reason, the dangers associated with hazardous chemicals covered by these criteria must be disclosed on the report, even though the information about the composition of the hazardous chemical is not fully provided. The supplier must make available to the receiver / user the complete FISPQ reporting relevant information on safety, health and environment. In the case of changes in the composition of the chemical entailing changes in its hazard classification, yet maintaining its trade name, the vendor must provide the various versions of that FISPQ related to the products on the market and ensure that the chemical use is correct and pertinent to aforementioned FISPQ. The preparation of the FISPQ requires product specific expertise in relation to the requirements of this part of the ABNT NBR 14725. The user of the FISPQ is responsible for acting in accordance with a risk assessment considering the conditions of product use, taking the necessary precautionary measures in a given situation at work and keeping the workers informed about the risks relevant to their workplace. The FISPQ user is responsible for choosing the best way to inform and train workers, at least, regarding the product identification, composition, hazard identification, first aid measures, fire fighting measures, control measures to avoid spilling or leakage, instructions to handle and store the product, exposure control measures and personal protection, information on the chemical stability and reactivity, toxicological information and considerations for treatment and disposal. When formulating the instructions specific to the workplace, the receiver must take into account the relevant recommendations of the FISPQ for each product.
The quantitative information contained in the description must be expressed by the International System of Units (SI). NOTE The description serves as a basis for preparing the label and the emergency form, rather than replacing these documents.
5 Content and general model of a FDS

The information in the FDS (Ficha de Dados de Segurana [Safety Data Sheet SDS]) should be presented using the following 16 headings in the order given below. 1. Identification 2. Hazard(s) identification 3. Composition/information on ingredients 4. First-aid measures 5. Fire-fighting measures 6. Accidental release measures 7. Handling and storage 8. Exposure controls/personal protection 9. Physical and chemical properties 10. Stability and reactivity 11. Toxicological information
ABNT NBR 14725-4:2009

12. Ecological information 13. Disposal considerations 14. Transport information 15. Regulatory information 16. Other information
Each SDS section correspondent to its standard title should be completed in accordance with the instructions and recommendations in Annex A (chemical). A SDS sample model is provided in Annex B.
ABNT NBR 14725-4:2009

Anexo A (normativo) Instrues para a elaborao de uma FISPQ
Annex A
(normative)
Instructions for preparation of the Safety Data Sheet (FDS)

The instructions in this Annex should be followed for the preparation of a SDS. The purpose of this Annex is to ensure that the contents of each section can enable users to take the required measures related to security, health and environment. The 16 sections of the SDS must be completed in accordance with the recommendations and requirements of this Annex. Each SDS section can be divided by subheadings. However, unlike the 16 standard titles, subheadings are not required. The 16 sections should be clearly separated. Headings and subheadings should have detachable presentation. This Annex lists the major subheadings used to complete the 16 sections. The SDS may have additional subheadings. The subheadings terminology is not mandatory, it is recommended. Information not specific related to one of the subheadings listed in this Annex, but deemed relevant to the SDS, can be presented in an additional subheading named, for instance, "other information" or "specific data".
Such information, relevant to safety, health and environment, should be provided for each one of the 16 sections. The reason for unavailability of certain information should be explained. Blanks are not allowed, except in Section 16, "Other information". Sources of information do not necessarily need to be mentioned, except as noted in this part of ABNT NBR 14725. Each SDS page should include the product name as used on the product label and should be numbered and dated. The system for numbering the pages should point out the total number of pages, or indicate the last page as such. The date mentioned should correspond to the last revision. SDS texts should be written in Portuguese (Brazil), capable to be read and in an understandable, clear and concise language. Common phrases are recommended.
1. Identification of the substance or mixture and of the supplier

This section should inform the product name (trade name) as used in the chemical label, the supplier product code if existent, as well as the supplier company name, its address and the contact telephone number of one of the company units. The supplier emergency telephone number should be given. The fax number and e-mail of the company may be given, as well.
2. Hazards identification
This section should present clearly and concisely the hazards and the most relevant effects of the product (adverse effects on the human health, environmental effects, physical and chemical hazards) and when appropriated, it should present the specific hazards. The main symptoms can be informed also. The chemical classification of the product and the classification system used should be informed. The product classification should be done following the guidelines of the ABNT NBR 14725-2.
ABNT NBR 14725-4:2009

A general view of the emergency situations should be provided, as well. Based on the classification, the proper elements to accomplish the labeling (symbol name, signal(s) word, hazard statements and precautionary statement) should be provided.
3. Composition/information on ingredients
This section should inform if the chemical is a substance or a mixture. Should it be a substance, the chemical name or the common name should be given. At least one synonymous, if existent, and the register number in the Chemical Abstract Service (CAS) should be provided. Impurities contributing to the hazard should be pointed out also, together with the respective CAS register. In case of a mixture, the chemical nature of the product should be informed. It is not required to inform the complete composition of the mixture. Ingredients or impurities contributing to the hazardous nature of the chemical should be informed, including its chemical or common name, the CAS register number and its concentration or concentration range, provided that they are participating in the mixture in higher concentration than the concentration cut off/limits defined for each hazard class in Table A.1. The classification of the mixture can be obtained based on the classification of the ingredients contributing to the hazard. Table A.1 - Cut-off values/Concentration limits for each health and environmental hazard class Hazard class Acute toxicity Skin corrosion/Irritation Serious damage to eyes/eye irritation Cut-off value /Concentration Limit % 1,0 1,0 1,0 1,0 0,1 1,0 0,1 0,1 1,0 1,0 1,0
Respiratory/Skin sensitization Mutagenicity: Category 1 Mutagenicity: Category 2 Carcinogenicity Reproductive toxicity Specific target organ systemic toxicity (single exposure) Specific target organ systemic toxicity (repeated exposure) Hazardous to the aquatic environment
Should any ingredient contributing for the hazard is bind by Confidential Business Information CBI (in Brazil, besides trade secret, also used "commercial secret", "industrial secret"), according with the existent relevant regulations, the supplier will not be required to inform the chemical name or the common name, the CAS register name and the concentration or concentration range of such ingredient in the FISPQ of such hazardous chemical product to abide the CBI requirements. However, the associate hazards to such ingredient(s) should be informed. When any information regarding the composition is omitted due to the prevailing trade secret, an informative phrase should be inserted, such as: "Confidential information retained", "Industrial secret", "Confidential information".
ABNT NBR 14725-4:2009 4. First aid measures

This section should inform the first aid measures to be taken and point out which action should be avoided. The information should be simple to be easily understood to both, to the victim and to the person giving help. The information should be divided according to the exposition routes, e.g., inhalation, skin contact, eye contact and ingestion. When pertinent, recommendation should be given to protect the helper person and/or to call the medical attention through annotations. "Annotation to call medical attention" above mentioned refer to measures that should only be executed by or under such professional
5. Fire-fighting measures
This section should inform the fire extinguishing media deemed recommended and those not recommended. All specific hazards related to the measures and the special firefighting methods, and the special equipment required for protection of the people involved in the firefighting, should be pointed out. The specific hazard situations that may arise during a chemical combustion should be pointed out, as well.
6. Accidental release control of spilling and leakage

This section should inform on the following: Specific instructions related to personal precautions (e.g., removal of ignition sources, dust control, prevention of inhalation and skin contact, mucous membranes, and eyes) in cases of spilling and leakage (see FISPQ, Section 8); Measures to be taken related to precautions to protect the environment (e.g., preventing inflow through obstacles, containing barriers, ditches) keeping the discharge from reaching sewers, soil and water courses. emergency measures and alarm systems (e.g., need to leave the area); Cleaning up measures (e.g., collection, neutralization, decontamination, absorbent materials and vacuum dust aspiration). The accomplishment of the final disposal should follow the steps of FISPQ, Section 13.
These information should include prevention of subsidiary hazards (e.g., ignition sources, spark proof tools, etc). Distinctions should be made between control measures against large and small spills or leaks.
7. Handling and storage

This sections provides guidance concerning the handling and storage of a substance or mixture as follows: a) 1) Handling: This item should describe the appropriate handling methods (work exposure prevention, fire and explosion prevention) and precautions for the safe of the chemical, such as local and total ventilation, and measures to prevent airborne particles, vapors and gases. It should bring forth guidance for the safe handling, such as how to avoid contact the contact with incompatible materials and environment contaminations; This item should outline the appropriate and inappropriate general warnings, as well (e.g., general hygiene such as keeping from eating, drinking, and smoking in the work place; removal of contaminated clothing and protection equipment before entering feeding areas); Storage: 11) This section should describe suitable and unsuitable technical measures for storage ; 2) The given recommendation should be consistent with the physical and chemical properties (see FISPQ, Section 9). If the recommendations are deemed pertinent, specific recommendation addressed to the How to avoid explosive atmospheres, corrosivity, flammability, incompatibilities, evaporation and ignition sources;
2)
b)
ABNT NBR 14725-4:2009

Environmental conditions of the storage (e.g., pressure, temperature, sun light, and moisture); How to keep the integrity of the substance or mixture using stabilizers and antioxidants; Other recommendations: For instance, ventilation requirements, specific designs for locals/storage containers, and compatible packages
8. Exposure controls/personal protection.

This section should indicate specific control parameters for substance or ingredients of the mixture (see FISPQ, Section 3), such as tolerance, limits and/or exposure biological indicators or other limits and values, jointly with the pointed references, preferably dated. The chemical or common name or the CAS register number, as specified in Section 3 of FISPQ, should be used when listing the occupational exposure limits. Control engineering measures for elimination or risk minimization, if pertinent, also should be pointed out. The description of the engineering controls should report the conditions of use of the substance or mixture. It is necessary to perform a risk assessment before establishing which engineering controls are recommended. For example:
a) b) c) d) e)
maintain air concentrations below occupational exposure standards use general ventilation system or local exhaust ventilation; use only in an enclosed system or hermetic system; use only in booth; use mechanical handling to reduce human contact with materials, or use explosive dust handling controls.
f)
The information provided in this section should complete Section 7 of FISPQ. According to the good practices of occupational hygiene, the Personal Protection Equipment (PPE) should be used jointly with other control measures, including the engineering controls (see Section 5 of FISPQ).
ABNT NBR 14725-4:2009

Identification of the required PPE to minimize potential health hazards due to exposure to the substance or mixture, including: a) b) c) Eyes and face protection: Specify the kind of eye and/or face protection commensurate to the hazard presented by the substance or mixture and its contact potential; Skin protection: Specify the protection equipment to be used (e.g., glove type, shoe, body protection) based on hazard- associated to the substance or mixture and its contact potential; Respiratory protection: Specify the kind of respiratory protection based on hazard and exposure potential, including respiratory protection equipment supported by dependent (filter masks cartridges) or independent (self-sustained) equipment. Extreme upper or lower temperatures (thermal danger): The specific PPE for such condition should be informed whenever the product presents as thermal hazard. Example: Organic peroxides.
d)
Special requirements may prevail for gloves or other protection clothing to prevent skin, eye or lung exposure. This type of PPE should be clearly specified, if pertinent, e.g., PVC gloves or nitrile rubber gloves, thickness and wear down time of the glove material. It may be necessary to provide special requirements for Personal Protection Equipments (PPE). This section should mention the PPE required for the treatment and disposal of product wastes and used packages, according FISPQ, Section 13. If the PPE for handling and storage of the hazardous chemical is different from the PPE for emergency care, it should be specified in this section.
9. Physical and chemical properties

This section should include information about the chemical. In the case of a mixture, it should be clearly pointed out to which ingredient the information is applicable, unless if it is valid for the mixture as a whole.
The properties listed below should be clearly identified as well as their measurement units according to International System of Units (SI) and Conmetro Resolutions 11 and 12. Other units also may be used, but only as additional information. The determination method should be informed as well, if pertinent for the interpretation of the numeric value (for instance, the flash point, method of the closed or open vessel). This section should contain the following items jointly with their respective information: Appearance (physical state, color); Odor threshold; pH; Melting point/freezing point; Initial boiling point and boiling range; Flash point; Evaporation rate; Flammability;
ABNT NBR 14725-4:2009

Upper/lower flammability or explosive limits; vapor pressure; vapor density; density; solubility; Partition coefficient: n-octanol/water; Auto-ignition temperature; Decomposition temperature; Viscosity.
If specific characteristics do not apply or are not available, they should be listed as "not applicable" or "not available" and if any item is not applicable or is not available it should be mentioned "not applicable" or "not available". Other physical or chemical parameters in addition to those listed above may also be included in this section.
10. Stability and reactivity

This section should outline: a) Chemical stability Indicate if the substance or mixture is stable or unstable under the normal conditions of temperature and pressure. Indicate in which temperature and pressure, during the storage or handling, the substance or mixture is stable or instable;
b)
Reactivity Describe the reactivity hazards of the substance or mixture in this section. If data for mixtures are not available, ingredient data should be provided;
c)
Possibility of hazardous reactions If relevant, state if the substance or mixture will react or polymerize, releasing excess pressure or heat, or creating other hazardous conditions. Describe under what conditions the hazardous reactions may occur. Also, state under which conditions hazardous reactions may occur;
d)
Conditions to be avoided List conditions to be avoided, such as: temperature, pressure, shock/impact/attrition, light, static discharge, vibrations, aging, moisture or other conditions that might result in a hazardous situation;
e)
Incompatible materials: List classes of chemicals or specific substances with which the substance or mixture could react to produce a hazardous situation (e.g. explosion, release of toxic or flammable materials, liberation of excessive heat); In the determination of incompatibility, the contamination that a substance or mixture can be exposed during its transportation, storage and use should consider also its container;
f)
Hazardous decomposition products List known hazardous decomposition products produced as a result of use, storage and heating; Hazardous combustion products should be included in Section 5 of FISPQ.
ABNT NBR 14725-4:2009 11. Toxicological information

This section is used primarily by medical professionals, toxicologists and occupational health safety professionals. It should be provided a concise but complete and comprehensible description of the various toxicological effects, as well as the available data used to identify those effects. According to ABNT NBR 14725-2, it should be provided, if relevant: Acute toxicity; Skin corrosion/Irritation; Serious damage to eyes/eye irritation; Respiratory/Skin sensitization; Germ cell mutagenicity; Carcinogenicity; Toxicity to reproduction and lactation; Specific target organ systemic toxicity (single exposure); Specific target organ systemic toxicity (repeated exposure); Aspiration hazard.
It should be stated if any of these hazards are not available.
The data included in this section should apply to the substance or mixture. It should be provided the toxicological data should of the mixture. provided the toxicological properties of the hazardous ingredients. If that information is not available, it should be
The health effects included in the FISPQ should be consistent with those described in the studies used for the classification of the substance or mixture. General statements such as Toxic (without supporting data justifying such classification) or Safe if properly used are not acceptable. Phrases such as not applicable, not relevant, or leaving blank spaces in the health effects section can lead to confusion and misunderstanding and should not be used. It should be describe the product effects and the relevant distinctions to health. For example, allergic contact dermatitis and irritant contact dermatitis should be distinguished from each other. When there is a substantial amount of test data on the substance or mixture, the results should be summarize. Also provide information in the case of negative results of the test data of the substance or mixture, e.g. carcinogenicity studies in the rat have shown no significant increase in the incidence of cancer. This section should outline: a) Routes of exposure: Inform routes of exposure (inhalation, ingestion and skin/eyes exposure) and the effects of the substance or mixture for each of them. A statement should be made if health effects are not known. b) Inform symptoms related to the physical, chemical and toxicological characteristics: Describe the potential adverse effects to health and the symptoms associated to exposure to the substance or mixture and to their ingredients or known by-products; Supply information about the symptoms related to the physical, chemical and toxicological of the substance or mixture according to its use. Describe the symptoms observed in both, exposure to
10
ABNT NBR 14725-4:2009

low concentrations / doses, and more severe exposures. For example: Headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses may result in coma and death c) Delayed or immediate effects and also chronic effects consistent with short and long exposures periods: Supply information whether delayed or immediate effects should be expected after short or long exposures periods; Also, supply information about acute and chronic effects related to human exposure to the substance or mixture. Whenever human data is not available, animal data should be summarized and the species clearly identified. It should be indicated if the toxicological data was obtained from human data or animal data. d) Inform about the toxicological data (such as acute toxicity estimates); Provide information on dosages, concentration and exposure conditions which may cause adverse effects on health; Dosages should be associated to symptoms and effects, including the most likely exposure period to be harmful; e) Substances that may cause interaction, addition, potentiation and sinergy: Information about reactions is to be included, if pertinent and available; f) Not available specific chemical data: Not always the information about the hazards of a substance or mixture can be obtained. When the data from the substance or mixture are not available, chemical class data can be used on, if appropriate. It should be mentioned when general data are either used or not available; g) Mixtures if a mixture is not tested for its effects on health as a whole, then the information of each ingredient listed in Section 3 of the FISPQ should be provided and the mixture should be classified according to ABNT NBR 14725-2, i.e., mixture of ingredients versus information about the ingredients. NOTE Ingredients can interact among themselves in the organism producing different rates of absorption, metabolism and elimination. As a result, toxic actions may be modified and the ultimate toxicity of the mixture may be different of its ingredients. It is required to take into account if the concentration of each ingredient is sufficient to contribute to the final effects of the mixture upon health. The information about the toxic effects should be presented for each ingredient, except:
1)
If the information is duplicated is it required to list it just once. For instance, if two ingredients cause vomiting and diarrhea, it will not be necessary list that ingredient twice. The mixture is generally described as causing vomiting and diarrhea; If it is not likely that the effects occur in the existent concentrations. For example, for example, when a mild irritant is diluted in a non-irritating solution, the overall mixture would be unlikely to cause irritation. Anticipate the interactions among ingredients is extremely difficult, and when the information on the reactions is not available, it is not possible to make assumptions;
2) 3) i)
Other information: Other pertinent information about adverse effects should be included, even when not required by ABNT NBR 14725-2.
12. Ecological information

Information should be provided to assess the environmental impact of the substance or mixture when released to the environment. This information can help in cases of leaks / spills, as well as in waste management practices
11
ABNT NBR 14725-4:2009

This section should clearly point out species, medium, units, conditions and duration of tests. Some ecological properties of specific substances, such as bioaccumulation, persistence and degradability should be provided, when available, for each ingredient of the mixture. A data summary should be provided, as follows: a) Ecotoxicity: Ecotoxicological information may be provided using data from tests in aquatic and/or terrestrial organism. This information should include the relevant data available relevant to acute and chronic aquatic toxicity for fish, crustaceans, algae and other aquatic plants;
Data on toxicity to other organisms should be included when available, (also mentioning soil micro and macro-organisms such as birds, bees and plants); If a substance or mixture has inhibitory effects on the activity of microorganisms, it should be mentioned that this may have an impact on wastewater treatment plants. b) Persistence e degradability: Degradability tests results deemed relevant should be make available; When the half-life of degradation of a substance is determined, it should be indicated if it was obtained through testing of degradation by mineralization or by primary degradation; It should be mentioned the potential of the substance or of certain ingredients of the mixture to undergo degradation in wastewater treatment plants. c) Bioaccumulation potential: Bioaccumulation tests results deemed relevant should be make available. These results should include, if available, reference to testing partition coefficient n-octanol-water (Kow) and for the bioconcentration factor (BCF).
d)
Mobility in soil It should be provided the results obtained from tests of adsorption and leaching, such as assays on the partition coefficient n-octanol-water (Kow), if considered relevant. Leaching and mobility can also be obtained from theoretical models. Actual data of the substance or mixture, when available, outweigh the theoretical models.
e)
outros efeitos adversos: When available information exists on other adverse effects to the environment, it should be included, for instance: Environmental damages; potential decrease of the ozone layer; photochemical ozone formation potential; endocrine disrupting potential and the global-warming potential.
13. Considerations regarding treatment and disposal

This section should inform the recommended methods for treatment and safe disposal and environmentally approved. These methods of treatment and disposal (e.g., co-processing, incineration, etc) should be applied to the product, waste products and packaging used. The user should be reminded about the possible existence of local regulations for treatment and disposal.
14. Transport information

This section should inform on code and classifications in accordance to national and international regulations for transport through different systems, such as: a) Terrestrial (rail line, highways): National Land Transport Agency (ANTT) ;
12
ABNT NBR 14725-4:2009

b) Waterway (maritime, inland shipment through rivers and lakes): IMDG code (International Maritime Dangerous Goods Code); DPC Standard 5 (Brazilian Directorate of Ports and Coasts of the Brazilian Navy); ANTAQ (National Water Transportation Agency); Aerial: ICAO-TI (International Civil Aviation Organization - Technical Instructions), IATA-DGR (International Air Transport Association Dangerous Goods Regulations); DAC (Department of Civil Aviation)
c)
For products classified as hazardous for transport , it should be pointed out, when suitable and depending upon the modal: a) b) c) d) e) f) UN number; Suitable shipment name; Main and subsidiary class/subclass risks, if pertinent; Risk number; Packing group; Other specific information, for instance, indicate whether the substance or mixture is known as a marine pollutant for waterway transport (IMDG Code), terrestrial or aerial..
Additional regulations may be mentioned. It should be inform, if deemed significant, the measures and precautionary conditions specific to the transport. . Information on transport modal mentioned in this section should be written in Portuguese (Brazil) and, when deemed necessary, in English.
15. Regulations
This section should contain information about regulations specifically applicable to the chemical product.
The user should be reminded about the possible existence of local regulations for treatment and disposal. Any other regulatory information on the chemical that is not covered elsewhere in this part of ABNT NBR 14725 should be described, if deemed applicable, for example: Requirements from the Ministry of Health (ANVISA), Ministry of Defense, Federal Police Department, Mercosur Agreement, and from the Chemical Weapons Convention, Stockholm Convention, Rotterdam Convention, Montreal Protocol, Kyoto Protocol, etc.
16. Other information

This section should provide any other information that may be significant from the standpoint of safety, health and environment, but not specifically relevant to the previous sections. For example, it may be indicated the recommended use and possible restrictions to the chemical to comply with special needs of training. References may be pointed out. Legends of labels and abbreviations used in the FISPQ should be discussed in this section.
13
ABNT NBR 14725-4:2009
Annex B (informative) SDS orientative model for chemicals
Heading (at the beginning of every page)

Name of the chemical FISPQ number Page x/xx Date of last revision
1. Identification of the substance or mixture and identification of the supplier

Chemical names and common names (product trade name) Product code Name of the company Address Contact telephone number Emergency telephone number Fax E-mail
2. Hazards identification
Most relevant hazards Product effects Adverse human health effects Environmental effects Physical and chemical hazards Specific hazards Main symptoms Chemical hazards classification and classification system used Emergency overview Suitable elements for labeling
14
ABNT NBR 14725-4:2009 3. Composition and Information on Ingredients.

Define whether the chemical is a substance or a mixture If it is a substance: Chemical name or common name Synonymous CAS number Impurities contributing to the hazard (together with the CAS number)
If it is a mixture: Chemical name or common name Chemical nature Ingredients contributing to the hazard or impurities contributing to the hazard Chemical name or common name CAS number Concentration or concentration range Hazard classification Classification system used
4. First-aid measures
First-aid measures Inhalational Skin contact Eye contact Ingestion Conditions to be avoided Protection of first-aiders Notes to a physician
5. Fire-fighting measures
Suitable extinguishing media Not suitable extinguishing media Specific hazards related to the measures Special methods of fire fighting Protection of firefighters Specific hazards of chemical combustion of the product
6. Spill / leakage prevention control

Personal Precautions
15
ABNT NBR 14725-4:2009

Environmental precautions Emergency measures and alarm systems Methods for cleaning up Subsidiary hazard prevention Actions difference in case of leakages: significant leakages against less significant leakages
7. Handling and storage

Handling Suitable technical methods Worker exposure prevention Fire and explosion prevention Precautions and guidelines for safe handling Hygiene measures Suitable hygiene measures Not suitable hygiene measures Storage Technical measures Suitable conditions
Conditions to be avoided Packaging materials Recommended Unsuitable
16
ABNT NBR 14725-4:2009 8. Exposure controls / personal protection

Specific control parameters Occupational exposure limits Biological indicators Other limits and values Engineering control measures Suitable Personal Protection Equipment (PPE) Eyes and face protection Skin and body protection Respiratory protection Special precautions
9. Physical and chemical properties

Appearance (physical state, color) Odor pH Melting point / freezing point Initial boiling point and boiling temperature range Flash point Evaporation rate Flammability Lower / upper flammability or explosive limit Vapor pressure Vapor density Density Solubility Partition coefficient n-octanol/water Self-ignition temperature Decomposition temperature Viscosity
17
ABNT NBR 14725-4:2009 10. Stability and reactivity

Chemical stability Reactivity Possibility of hazardous reactions Conditions to be avoided Incompatible materials or substances Hazardous decomposition products
11. Toxicological information

Information according to the different exposure routes Acute toxicity Chronic toxicity Main symptoms Specific effects Substances that may cause Interaction effects Additive effects Potentiation effects
Synergistic effects
12. Ecological information

Environmental, behavioral and product impacts Ecotoxicity Persistence and degradability Bioaccumulation potential Mobility through soil Other adverse effects
13. Disposal and treatment considerations

Recommended treatment and disposal methods to the: Product Product wastes Used packages
18
ABNT NBR 14725-4:2009 14. Transport information

National and international regulations Terrestrial Waterway Aerial For products classified as hazardous for transport (modal-dependent) UN number Suitable shipment name Main and subsidiary class/subclass risks Risk number Packing group Additional recommendations
15. Regulations
Chemicals-specific regulations
16. Other information

Significant information, yet not specifically related to the previous sections Bibliographic references Labels and abbreviations
19
ABNT NBR 14725-4:2009
Bibliography
[1] [2] Decree 2657, of 03 of July of 1998, which publishes the Convention No 170 of the International Labour Organization (ILO) GHS book, Globally Harmonized System of Classification and Labeling of Chemicals (GHS) - Purple Book, 2005
20

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Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1

Chemicals Information about safety, health and environment Part 1: Terminology

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ICS 71.100.01 BRAZILIAN ASSOCIATION OF TECHNICAL STANDARDS

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Chemicals Information about safety, health and environment Part 1: Terminology

2 Terms and Definitions

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)

ABNT 2009 All rights reserved.

Freely available Standard through an ABNT-ABIQUIM Agreement

ABNT NBR 14725-1:2009

Marbow Resinas Ltd exclusive copy 08.970.866/0001-37 (Printed on 4/21/2010)