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ID: SDS00020004800_EN
HEMOSIL® SILICA CLOTTING TIME Revision: 02
CO: 460053
Edited on: 11/10/2015
Mixture classification
According to
Mixture classification
Hazard Communication Standard, Kit
P/N Mixture name According to
29 CFR 1910.1200 (HCS) configuration
1272/2008/EC Regulation
Hazardous Product Regulation HPR (WHMIS
2015)
Disclaimer
This document is intended only as a guide to appropriate precautionary handling of this product by a trained person, or supervised by a person
trained in chemical handling. The product shall not be used for purposes different from those indicated in section 1, unless having received
suitable written instructions on how to handle the material. Use the product in accordance with the Good Laboratory Practice. This document
cannot describe all potential dangers of use or interaction with other chemicals or materials. It is the user’s responsibility for the product’s safe
use, the product’s suitability for the intended use and the product’s safe disposal. No representation or warranties, either expressed or implied,
of merchantability, fitness for a particular purpose or of any other nature are made hereunder with respect to the information set forth herein
or to the product to which the information refers. The contained information in this SDS are in accordance with Annex II of the Regulation (EC)
No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals
(REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012) as
recommended by US OSHA, and in accordance with Hazardous Product Regulation HPR (WHMIS 2015) as recommended by Health Canada
(HC).
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According to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and
according to Hazardous Product Regulation HPR (WHMIS 2015):
Hazard class Hazard category Hazard statement
Not classified
For exposure limits see ch. 8
Potential adverse physicochemical, human health and environmental effects (see also ch. 9-12)
Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment.
2.2 Label elements, according to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR
1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015):
Safety precautions: Use the product in accordance with the Good Laboratory Practice.
Wear suitable protective clothing, gloves and eye/face protection.
Do not let the product enter drainage system, surface and ground-water or soil. Do not empty into drains.
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The mixture contains substances listed in the Hazardous Substance Lists and/or evaluated for carcinogenicity by IARC, NTP, OSHA: 1,2-
dibromo-2,4-dicyanobutane, formaldehyde. See Section 11 and 15.
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7.1 Precautions for safe handling Handle in a well ventilated place, and away from sparkles and flames - sources of ignition. Keep the
mixture away from drains, surface or ground waters. Avoid contact with incompatible materials. Wear
suitable Personal Protection Equipment (see section 8).
Do not eat, drink and smoke in the working areas. Wash hands with soap and water after handling
the mixture. Remove contaminated clothing and protective equipment before entering eating areas.
7.2 Conditions for safe storage, Recommended temperature: store at 2-8°C. Avoid light exposure and keep away from heat sources.
incompatibilities Room ventilation: well ventilated workplace. Keep containers tightly closed and labelled with the name
of the product. Avoid environmental release.
Keep away from food and drinks.
7.3 Specific end use SCT Screen is intended for in vitro diagnostic use. Use the product in accordance with the Good
Laboratory Practice.
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Latvia 0.5
Poland 0.5 1
Spain 0.3 0.37
(b) (b)
Sweden 0.3 0.37 0.6 0.74
Switzerland 0.3 0.37 0.6 0.74
The Netherlands 0.15 0.5
United Kingdom 2 2.5 2 2.5
(e)
USA-NIOSH 0.016 0.1
USA-OSHA 0.75 2
Canada - Ontario 1
(b)
1.5
(b) (b)
Canada - Québec 2 3
(2)
ACGIH (1987) TLV/STEL = 0.3 ppm. Notations: Sensitization; A2-Suspected human
carcinogen.
(a)
15 minutes average value;
(b)
ceiling limit value
(c)
A momentary value of 1 ml/m³ (1,2 mg/m³) should not be exceeded .
(d)
15 minutes reference period
(e)
Ceiling limit value (15 min)
* Short term is 15 minutes unless otherwise specified
Community/National biological exposure limit values: not available
DNEL Values (components):
Workers Consumers
Component Route of exposure Acute effects Chronic effects Acute effects Chronic effects
local systemic local systemic local systemic local systemic
(3)
Formaldehyde Oral (mg/kg bw/day) 4.1
Dermal (mg/kg bw/day) 37 µg/cm2 240 12 g/cm2 102
Inhalation (mg/m3) 1 0.5 9 0.1 3.2
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10.1 Reactivity This mixture is considered not reactive under the normal conditions of the usage.
10.2 Chemical stability The product is stable until the expiration date shown on the box and on the labels when stored at 2 –
8 °C.
10.3 Possibility of hazardous Not foreseen.
reactions
10.4 Conditions to avoid: Keep away from heat and light.
10.5 Incompatible materials Oxidising agents, reducing agents, acids.
10.6 Hazardous decomposition Thermal decomposition or combustion may generate toxic and hazardous fumes of COx, SOx, NOx.
products:
The health effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are provided
bellow.
11.1 Information on toxicological effects
Symptoms and effects for each route of exposure:
Dermal: May cause skin irritation.
Ingestion: Ingestion may cause irritation to the gastrointestinal mucous membranes.
Inhalation: May cause irritation to the mucous membranes and upper respiratory tract.
Contact with eyes: May cause eye irritation.
Toxicokinetic effects (Absorption, Distribution, Metabolism, Excretion):
1,2-dibromo-2,4-dicyanobutane (MDBGN ) is readily absorbed following oral and dermal administration. Once inside the body, is rapidly
metabolised to 2-MGN before eventually being eliminated from the body, mostly via urine. Debromination of MDBGN occurs prior to
systemic distribution; therefore, tissue exposure to parent chemical is expected to be low. (10)
Formaldehyde is rapidly absorbed from the respiratory tract and gastrointestinal and poorly absorbed following dermal application. The
substance will partition into richly vascularized organs, haematopoietic organs, gastrointestinal mucosa, exocrine pancreas, salivary
glands. Formaldehyde is metabolized by the enzyme formaldehyde dehydrogenase to formate and then the carbon atom is oxidized to
carbon dioxide or incorporated into purines, thymidine and aminoacids. Both formaldehyde and formate does not accumulate in tissues.
Acute toxicity Value m.u. Effects Related to
(11)
Oral: LD50 (rat) = 515 - 770 mg/Kg 1,2-dibromo-2,4-
dicyanobutane
(4,5)
LD50 (rat) = 100 mg/Kg Formaldehyde
(11)
Dermal: LD50 (rabbit) > 5,000 mg/Kg 1,2-dibromo-2,4-
dicyanobutane
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(6)
LD50 (rabbit) = 270 mg/Kg Formaldehyde
(12) (13)
Inhalation: LC50 (rat) > 5,09 mg/l/4h 1,2-dibromo-2,4-
LC50 (rat) > 13 dicyanobutane
LC50 (rat) = 578 mg/m3/4h (6)
Formaldehyde
Other data: not available
Corrosion/Irritation
Skin Corrosion/Irritation 1,2-dibromo-2,4-dicyanobutane (Technical 98%) was severe irritant to rabbit skin. (14)
Formaldehyde: Formaldehyde solutions cause irritation through to necrosis to the skin. Aqueous
solutions of 0.1% to 20% formaldehyde were irritating to rabbit skin. No skin irritation was seen at
0.1%. Brownish discoloration of the skin and nails, damage to the nail substance, inflammation of the
nail fold, blistering, inflammation and hardening of the skin were observed following intensive contact
with 4 - 10 % solutions. (4)(6)
Serious eye damage/ irritation 1,2-dibromo-2,4-dicyanobutane : In pure form (98%) is a severe eye irritant. Instillation of 1,2-
dibromo-2,4-dicyanobutane powder into the rabbit eye resulted in severe irritation, which persisted for
at least 21 days post-instillation.(10)
Formaldehyde: Depending on the concentration and medical treatment, contact of formaldehyde
solutions with the eyes causes slight, rapidly reversible irritation (eg due to 0.2 % solution) up to
persistent damage (permanent corneal opacity eg following contact with 40 % solution). (4)
Sensitization:
Skin sensitization: 1,2-dibromo-2,4-dicyanobutane : is a skin sensitizer agent, based on in vivo and in vitro animal data,
(10)(15)
and based on human data.
Formaldehyde: The strong skin sensitizing properties of formaldehyde have been proven in numerous
animal studies. In the LLNA in mice, an EC3 value of 0.29% has been established. In the human repeat
insult patch test, positive responses started at 1% (7)
Respiratory sensitization: Formaldehyde: available human and animal data indicates formaldehyde in air is unlikely to induce
respiratory sensitization.
CMR effects
Germ cell mutagenicity; 1,2-dibromo-2,4-dicyanobutane: did not show evidence of mutagenic activity in a variety of in vitro and
in vivo assays, except for one assay where increased frequencies of chromosomal aberrations in CHO
.
cells were observed in an in vitro chromosomal aberration test (10)(16)
Formaldehyde: Formaldehyde has been demonstrated as being genotoxic and mutagenic in vitro as
(7)(8)
well as in vivo at local sites of exposure, both in animals and humans.
Reproductive toxicity: 1,2-dibromo-2,4-dicyanobutane: In a study in rats exposed to 1,2-dibromo-2,4-dicyanobutane, a
NOAEL for developmental toxicity was determined to be 175 mg/kg bw. Available information suggests
that the substance is neither a reproductive nor a developmental toxin at doses that are not associated
with maternal toxicity. (1)(12)(16)
Formaldehyde: Based on animal and limited epidemiology data, formaldehyde is unlikely to cause
(6)
reproductive and developmental effects at exposures relevant to humans.
Carcinogenesis: Substances listed in the National Toxicology Program (NTP) Report on Carcinogens, in the International
Agency for Research on Cancer (IARC) Monographs or found to be potential carcinogen by OSHA:
Substance OSHA IARC NTP
Formaldehyde no Group 1 (2012) - Carcinogenic to Known to be Human
humans Carcinogens
No other component listed
1,2-dibromo-2,4-dicyanobutane: Under the conditions of 2-year dermal studies there was no evidence
of carcinogenic activity of 1,2-dibromo-2,4- dicyanobutane in male or female rats administered 2, 6, or
18 mg/kg. (10)(16)
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Formaldehyde: IARC (2004) reclassified formaldehyde from “probably carcinogenic to humans” (Group
2A) to “carcinogenic to humans” (Group 1) based on findings for nasal cancers from a large scale
epidemiologic study conducted by the US National Cancer Institute. In 2012, this classification was re-
affirmed by IARC after consideration of new studies.(7) The European Committee for Risk Assessment
RAC (2012) evaluated all available data and concluded the classification of the substance as Carc. 1B
for the following reasons: there is limited evidence of carcinogenicity in humans mainly from the
positive association of nasopharyngeal tumors in industrial cohorts; there is sufficient evidence of
carcinogenicity from animal studies to conclude that formaldehyde is a presumed human carcinogen;
formaldehyde is genotoxic in somatic cells at the site of contact.(8)
There are concerns of an increased risk for formaldehyde-induced myeloid leukemia, however, the data
are not considered sufficient to establish a causal association. (6)
STOT –single exposure Formaldehyde: is irritant to caustic for the respiratory system.
STOT – repeated exposure 1,2-dibromo-2,4-dicyanobutane : In long-term repeat feeding studies in animals, the observed effects
were thyroid follicular cell hypertrophy, thyroid hyperplasia, increased pigmentation of the liver and
spleen and increased extramedullary hematopoiesis when administered at high doses (4000 ppm) in
dogs. Follow-up studies found no significant changes in levels of thyroid hormones. Repeated dermal
application of 1,2-dibromo-2,4-dicyanobutane was associated with moderate to severe erythema and
slight to moderate edema. (10)(16)
Formaldehyde: Formaldehyde causes toxic effects only in the tissues of direct contact after inhalation,
oral or dermal exposure characterized by local cytotoxic destruction. Based on the available human and
animal data formaldehyde does not meet the criteria for classification as causing serious damage to
health by prolonged exposure through inhalation, ingestion or dermal contact. (6)
Aspiration hazards Not available.
Other information: Not available.
Reasons for the lack of classification:
Where the mixture resulted in a non-classification, this may be due to the availability of data which does not impose a classification for
that specific end-point, or due to lack of data, or due to availability of inconclusive data or data which are not sufficient to get a
classification as for the criteria adopted in Regulations mentioned in this data sheet.
The environmental effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are
provided bellow.
species, media, units, test duration and test
12.1 Toxicity conditions. Related to
(12)
Acute toxicity with fish: LC50 Salmo gairdneri = 1.75 mg/l/96 hour 1,2-dibromo-2,4-dicyanobutane
(9)
LC50(96 h) = 6.7 - 1020 mg/l Formaldehyde
(3)
Chronic toxicity with fish: NOEC ≥ 48 mg/L/28 d Formaldehyde
(12)
Acute toxicity with crustaceans: EC50 Daphnia magna = 6.16 mg/L/48 hr 1,2-dibromo-2,4-dicyanobutane
(9)
EC50= 29 mg/l/48h Formaldehyde
(3)
Chronic toxicity with NOEC ≥ 18.8 mg/L/35 d Formaldehyde
crustaceans:
(12)
Acute toxicity with algae: EC50 Selenastrum capricornutum =0.15 mg/L/72 hours 1,2-dibromo-2,4-dicyanobutane
(9)
EC50 =14.7 mg/24 h Formaldehyde
Chronic toxicity with algae: Not available.
(9)
Toxicity data on soil micro- and EC3 Pseudomonas putida = 14 mg/l/16h Formaldehyde
macroorganisms
(14)
Toxicity data on birds, bees and LD50 Mallard Duck = 1064 mg/kg 1,2-dibromo-2,4-dicyanobutane
plants: (98%)
12.2 Persistency and 1,2-dibromo-2,4-dicyanobutane is expected to degrade rapidly in aquatic environments. (14)
degradability:
Formaldehyde is water soluble and biodegradable. Hydrolysis is not expected under environmental
conditions.(6)(9)
12.3 Bioaccumulation potential: Formaldehyde: In view of the very low bioconcentration factor of 0.19, based on a log Kow of 0.65,
formaldehyde is not expected to bioaccumulate. No bioconcentration was observed in fish or shrimp.
12.4 Mobility in soil: 1,2-dibromo-2,4-dicyanobutane is expected to be very mobile and non persistent in aquatic and soil
environments. (14)
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Formaldehyde: is not expected to adsorb to soil particles to a great degree and would be considered
mobile in the soil, based on its estimated Koc.
12.5 Results of PBT and vPvB Not performed.
assessment
12.6 Other toxic effects: Not available.
National laws on disposal must be considered, local and UE requirements for wastes recycling must be respected.
13.1 Waste treatment methods
Used waste product, surplus product or spillage products shall be disposed of in accordance with national, state and local laws.
Not classified in accordance with ADR/RID, IMDG, IATA and DOT regulations.
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU Regulations
●
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of
workers at work (Official Journal L 183 , 29/06/1989 P. 0001 – 0008) and following amendment and National reinforcements.
●
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to the personal
protective equipment.
●
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical
agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Official Journal L 131 ,
05/05/1998 P. 0011 – 0023.
●
Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
●
Commission Regulation (EU) 2015/830 of 28 May 2015 amending Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
●
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December on classification, labelling and packaging
of substances and mixtures 2008 (and subsequent amendments and supplements).
Restriction of use: none
Substance(s) under authorization: none
US Federal Regulations:
State Components listed Note
Massachusetts Formaldehyde Carcinogen, Extraordinarily hazardous
New York Formaldehyde No note
1,2-dibromo-2,4-dicyanobutane No note
New Jersey
Formaldehyde Carcinogen, Corrosive, Mutagen, Flammable - Fourth Degree
Environmental hazard
Pennsylvania Formaldehyde
Special hazardous substance
California Prop. 65
Ingredient name Cancer Reproductive NSRL or MADL (µg/day)
Formaldehyde cancer - 40
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WEEL: Workplace Environmental Exposure Level (air concentration of agents in a healthy worker's
breathing zone)
Information related to the Regulation EC/1272/2008:
Hazard statement(s): H301: Toxic if swallowed.
H311: Toxic in contact with skin.
H331: Toxic if inhaled.
H314: Causes severe skin burns and eye damage.
H315: Causes skin irritation.
H317: May cause an allergic skin reaction.
H318: Causes serious eye damage.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
H341: Suspected of causing genetic defects
H350: May cause cancer.
H400: Very toxic to aquatic life.
Information on workers training: Follow National requirements to ensure protection of human health and the environment.
Classification and procedure used to derive the classification for mixtures according to Regulation (EC) 1272/2008,
according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to HPR (WHMIS 2015) :
Classification: Classification procedure
Not classified -
The contained information in this SDS are in accordance with Annex II of the COMMISSION REGULATION (EU) No
1907/2006 (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29
CFR 1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation
HPR (WHMIS 2015) as recommended by Health Canada (HC).
Bibliographic references:
(1)
GESTIS International Limit Values, available on http://limitvalue.ifa.dguv.de/WebForm_ueliste.aspx
(2)
ACGIH, TLVs and BEIs based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents &
Biological Exposure Indices, 2012
(3)
Formaldehyde, Registration Dossier on ECHA, available at http://apps.echa.europa.eu/registered/data/dossiers/DISS-9daa7594-c409-0ed0-
e044-00144f67d249/AGGR-3c0fcb62-7d2d-4fac-ba94-193b313f447b_DISS-9daa7594-c409-0ed0-e044-00144f67d249.html#AGGR-3c0fcb62-
7d2d-4fac-ba94-193b313f447b
(4)
Gestis Substance database, Formaldehyde, ZVG 10520
(5)
ChemIdplus Lite, Formaldehyde, full record
(6)
Priority Existing Chemical Assessment Report No. 28, Formaldehyde, November 2006, National Industrial Chemicals Notification and
Assessment Scheme
(7)
SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of the use of formaldehyde in nail hardeners,
SCCS/1538/14, written procedure 7 November 2014, revision of 16 December 2014.
(8)
Committee for Risk Assessment RAC, Opinion proposing harmonized classification and labeling at EU level of Formaldehyde
EC number: 200-001-8, CAS number: 50-00-0, CLH-O-0000003155-80-01/F, Adopted 30 November 2012
(9)
SIDS Initial Assessment Report For SIAM 14 Paris, France, March 2002, Formaldehyde
(10)
Australian Government, Department of Health and Ageing, NICNAS Existing Chemicals Information Sheet, Methyldibromo
Glutaronitrile, June 2009
(11)
NTP Nomination History and Review, 1,2-dibromo-2,4-dicyanobutane, CAS No. 35691-65-7
(12)
LANXESS, Material Safety Data Sheet for Tektamer 38LV
(13)
Gestis Substance database, 1,2-Dibromo-2,4-dicyanobutane, ZVG 139996
(14)
EPA R.E.D. Facts, DIBROMODICYANOBUTANE
(15)
SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS, SCCP, Opinion on Methyldibromo glutaronitrile (sensitization only), COLIPA n°
P77, Adopted by the SCCP during the 3rd plenary meeting of 15 March 2005
(16)
HSDB: 1,2-DIBROMO-2,4-DICYANOBUTANE, available at http://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~tRCfcl:1
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According to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and
according to Hazardous Product Regulation HPR (WHMIS 2015):
Hazard class Hazard category Hazard statement
Not classified
For exposure limits see ch. 8
Potential adverse physicochemical, human health and environmental effects (see also ch. 9-12)
Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment.
2.2 Label elements, according to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR
1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015):
Safety precautions: Use the product in accordance with the Good Laboratory Practice.
Wear suitable protective clothing, gloves and eye/face protection.
Do not let the product enter drainage system, surface and ground-water or soil. Do not empty into drains.
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The mixture contains substances listed in the Hazardous Substance Lists and/or evaluated for carcinogenicity by IARC, NTP, OSHA: 1,2-
dibromo-2,4-dicyanobutane, formaldehyde. See Section 11 and 15.
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7.1 Precautions for safe handling Handle in a well ventilated place, and away from sparkles and flames - sources of ignition. Keep the
mixture away from drains, surface or ground waters. Avoid contact with incompatible materials. Wear
suitable Personal Protection Equipment (see section 8).
Do not eat, drink and smoke in the working areas. Wash hands with soap and water after handling
the mixture. Remove contaminated clothing and protective equipment before entering eating areas.
7.2 Conditions for safe storage, Recommended temperature: store at 2-8°C. Avoid light exposure and keep away from heat sources.
incompatibilities Room ventilation: well ventilated workplace. Keep containers tightly closed and labelled with the name
of the product. Avoid environmental release.
Keep away from food and drinks.
7.3 Specific end use SCT Confirm is intended for in vitro diagnostic use. Use the product in accordance with the Good
Laboratory Practice.
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(d) (d)
Ireland 2 2.5 2 2.5
Latvia 0.5
Poland 0.5 1
Spain 0.3 0.37
(b) (b)
Sweden 0.3 0.37 0.6 0.74
Switzerland 0.3 0.37 0.6 0.74
The Netherlands 0.15 0.5
United Kingdom 2 2.5 2 2.5
(e)
USA-NIOSH 0.016 0.1
USA-OSHA 0.75 2
Canada - Ontario 1
(b)
1.5
(b) (b)
Canada - Québec 2 3
(2)
ACGIH (1987) TLV/STEL = 0.3 ppm. Notations: Sensitization; A2-Suspected human
carcinogen.
(a)
15 minutes average value;
(b)
ceiling limit value
(c)
A momentary value of 1 ml/m³ (1,2 mg/m³) should not be exceeded .
(d)
15 minutes reference period
(e)
Ceiling limit value (15 min)
* Short term is 15 minutes unless otherwise specified
Community/National biological exposure limit values: not available
DNEL Values (components):
Workers Consumers
Component Route of exposure Acute effects Chronic effects Acute effects Chronic effects
local systemic local systemic local systemic local systemic
(3)
Formaldehyde Oral (mg/kg bw/day) 4.1
Dermal (mg/kg bw/day) 37 µg/cm2 240 12 g/cm2 102
Inhalation (mg/m3) 1 0.5 9 0.1 3.2
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10.1 Reactivity This mixture is considered not reactive under the normal conditions of the usage.
10.2 Chemical stability The product is stable until the expiration date shown on the box and on the labels when stored at 2 –
8 °C.
10.3 Possibility of hazardous Not foreseen.
reactions
10.4 Conditions to avoid: Keep away from heat and light.
10.5 Incompatible materials Oxidising agents, reducing agents, acids.
10.6 Hazardous decomposition Thermal decomposition or combustion may generate toxic and hazardous fumes of COx, SOx, NOx.
products:
The health effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are provided
bellow.
11.1 Information on toxicological effects
Symptoms and effects for each route of exposure:
Dermal: May cause skin irritation.
Ingestion: Ingestion may cause irritation to the gastrointestinal mucous membranes.
Inhalation: May cause irritation to the mucous membranes and upper respiratory tract.
Contact with eyes: May cause eye irritation.
Toxicokinetic effects (Absorption, Distribution, Metabolism, Excretion):
1,2-dibromo-2,4-dicyanobutane (MDBGN ) is readily absorbed following oral and dermal administration. Once inside the body, is rapidly
metabolized to 2-MGN before eventually being eliminated from the body, mostly via urine. Debromination of MDBGN occurs prior to
systemic distribution; therefore, tissue exposure to parent chemical is expected to be low. (10)
Formaldehyde is rapidly absorbed from the respiratory tract and gastrointestinal and poorly absorbed following dermal application. The
substance will partition into richly vascularized organs, hematopoietic organs, gastrointestinal mucosa, exocrine pancreas, salivary
glands. Formaldehyde is metabolized by the enzyme formaldehyde dehydrogenase to formate and then the carbon atom is oxidized to
carbon dioxide or incorporated into purines, thymidine and aminoacids. Both formaldehyde and formate does not accumulate in tissues.
Acute toxicity Value m.u. Effects Related to
(11)
Oral: LD50 (rat) = 515 - 770 mg/Kg 1,2-dibromo-2,4-
dicyanobutane
(4,5)
LD50 (rat) = 100 mg/Kg Formaldehyde
(11)
Dermal: LD50 (rabbit) > 5,000 mg/Kg 1,2-dibromo-2,4-
dicyanobutane
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(6)
LD50 (rabbit) = 270 mg/Kg Formaldehyde
(12) (13)
Inhalation: LC50 (rat) > 5,09 mg/l/4h 1,2-dibromo-2,4-
LC50 (rat) > 13 dicyanobutane
LC50 (rat) = 578 mg/m3/4h (6)
Formaldehyde
Other data: not available
Corrosion/Irritation
Skin Corrosion/Irritation 1,2-dibromo-2,4-dicyanobutane (Technical 98%) was severe irritant to rabbit skin. (14)
Formaldehyde: Formaldehyde solutions cause irritation through to necrosis to the skin. Aqueous
solutions of 0.1% to 20% formaldehyde were irritating to rabbit skin. No skin irritation was seen at
0.1%. Brownish discoloration of the skin and nails, damage to the nail substance, inflammation of the
nail fold, blistering, inflammation and hardening of the skin were observed following intensive contact
with 4 - 10 % solutions. (4)(6)
Serious eye damage/ irritation 1,2-dibromo-2,4-dicyanobutane : In pure form (98%) is a severe eye irritant. Instillation of 1,2-
dibromo-2,4-dicyanobutane powder into the rabbit eye resulted in severe irritation, which persisted for
at least 21 days post-instillation.(10)
Formaldehyde: Depending on the concentration and medical treatment, contact of formaldehyde
solutions with the eyes causes slight, rapidly reversible irritation (eg due to 0.2 % solution) up to
persistent damage (permanent corneal opacity eg following contact with 40 % solution). (4)
Sensitization:
Skin sensitization: 1,2-dibromo-2,4-dicyanobutane : is a skin sensitizer agent, based on in vivo and in vitro animal data,
(10)(15)
and based on human data.
Formaldehyde: The strong skin sensitizing properties of formaldehyde have been proven in numerous
animal studies. In the LLNA in mice, an EC3 value of 0.29% has been established. In the human repeat
insult patch test, positive responses started at 1% (7)
Respiratory sensitization: Formaldehyde: available human and animal data indicates formaldehyde in air is unlikely to induce
respiratory sensitization.
CMR effects
Germ cell mutagenicity; 1,2-dibromo-2,4-dicyanobutane: did not show evidence of mutagenic activity in a variety of in vitro and
in vivo assays, except for one assay where increased frequencies of chromosomal aberrations in CHO
.
cells were observed in an in vitro chromosomal aberration test (10)(16)
Formaldehyde: Formaldehyde has been demonstrated as being genotoxic and mutagenic in vitro as
(7)(8)
well as in vivo at local sites of exposure, both in animals and humans.
Reproductive toxicity: 1,2-dibromo-2,4-dicyanobutane: In a study in rats exposed to 1,2-dibromo-2,4-dicyanobutane, a
NOAEL for developmental toxicity was determined to be 175 mg/kg bw. Available information suggests
that the substance is neither a reproductive nor a developmental toxin at doses that are not associated
with maternal toxicity. (1)(12)(16)
Formaldehyde: Based on animal and limited epidemiology data, formaldehyde is unlikely to cause
(6)
reproductive and developmental effects at exposures relevant to humans.
Carcinogenesis: Substances listed in the National Toxicology Program (NTP) Report on Carcinogens, in the International
Agency for Research on Cancer (IARC) Monographs or found to be potential carcinogen by OSHA:
Substance OSHA IARC NTP
Formaldehyde no Group 1 (2012) - Carcinogenic to Known to be Human
humans Carcinogens
No other component listed
1,2-dibromo-2,4-dicyanobutane: Under the conditions of 2-year dermal studies there was no evidence
of carcinogenic activity of 1,2-dibromo-2,4- dicyanobutane in male or female rats administered 2, 6, or
18 mg/kg. (10)(16)
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Formaldehyde: IARC (2004) reclassified formaldehyde from “probably carcinogenic to humans” (Group
2A) to “carcinogenic to humans” (Group 1) based on findings for nasal cancers from a large scale
epidemiologic study conducted by the US National Cancer Institute. In 2012, this classification was re-
affirmed by IARC after consideration of new studies.(7) The European Committee for Risk Assessment
RAC (2012) evaluated all available data and concluded the classification of the substance as Carc. 1B
for the following reasons: there is limited evidence of carcinogenicity in humans mainly from the
positive association of nasopharyngeal tumors in industrial cohorts; there is sufficient evidence of
carcinogenicity from animal studies to conclude that formaldehyde is a presumed human carcinogen;
formaldehyde is genotoxic in somatic cells at the site of contact.(8)
There are concerns of an increased risk for formaldehyde-induced myeloid leukemia, however, the data
are not considered sufficient to establish a causal association. (6)
STOT –single exposure Formaldehyde: is irritant to caustic for the respiratory system.
STOT – repeated exposure 1,2-dibromo-2,4-dicyanobutane : In long-term repeat feeding studies in animals, the observed effects
were thyroid follicular cell hypertrophy, thyroid hyperplasia, increased pigmentation of the liver and
spleen and increased extramedullary hematopoiesis when administered at high doses (4000 ppm) in
dogs. Follow-up studies found no significant changes in levels of thyroid hormones. Repeated dermal
application of 1,2-dibromo-2,4-dicyanobutane was associated with moderate to severe erythema and
slight to moderate edema. (10)(16)
Formaldehyde: Formaldehyde causes toxic effects only in the tissues of direct contact after inhalation,
oral or dermal exposure characterized by local cytotoxic destruction. Based on the available human and
animal data formaldehyde does not meet the criteria for classification as causing serious damage to
health by prolonged exposure through inhalation, ingestion or dermal contact. (6)
Aspiration hazards Not available.
Other information: Not available.
Reasons for the lack of classification:
Where the mixture resulted in a non-classification, this may be due to the availability of data which does not impose a classification for
that specific end-point, or due to lack of data, or due to availability of inconclusive data or data which are not sufficient to get a
classification as for the criteria adopted in Regulations mentioned in this data sheet.
The environmental effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are
provided bellow.
species, media, units, test duration and test
12.1 Toxicity conditions. Related to
(12)
Acute toxicity with fish: LC50 Salmo gairdneri = 1.75 mg/l/96 hour 1,2-dibromo-2,4-dicyanobutane
(9)
LC50(96 h) = 6.7 - 1020 mg/l Formaldehyde
(3)
Chronic toxicity with fish: NOEC ≥ 48 mg/L/28 d Formaldehyde
(12)
Acute toxicity with crustaceans: EC50 Daphnia magna = 6.16 mg/L/48 hr 1,2-dibromo-2,4-dicyanobutane
(9)
EC50= 29 mg/l/48h Formaldehyde
(3)
Chronic toxicity with NOEC ≥ 18.8 mg/L/35 d Formaldehyde
crustaceans:
(12)
Acute toxicity with algae: EC50 Selenastrum capricornutum =0.15 mg/L/72 hours 1,2-dibromo-2,4-dicyanobutane
(9)
EC50 =14.7 mg/24 h Formaldehyde
Chronic toxicity with algae: Not available.
(9)
Toxicity data on soil micro- and EC3 Pseudomonas putida = 14 mg/l/16h Formaldehyde
macroorganisms
(14)
Toxicity data on birds, bees and LD50 Mallard Duck = 1064 mg/kg 1,2-dibromo-2,4-dicyanobutane
plants: (98%)
12.2 Persistency and 1,2-dibromo-2,4-dicyanobutane is expected to degrade rapidly in aquatic environments. (14)
degradability:
Formaldehyde is water soluble and biodegradable. Hydrolysis is not expected under environmental
conditions.(6)(9)
12.3 Bioaccumulation potential: Formaldehyde: In view of the very low bioconcentration factor of 0.19, based on a log Kow of 0.65,
formaldehyde is not expected to bioaccumulate. No bioconcentration was observed in fish or shrimp.
12.4 Mobility in soil: 1,2-dibromo-2,4-dicyanobutane is expected to be very mobile and non persistent in aquatic and soil
environments. (14)
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Formaldehyde: is not expected to adsorb to soil particles to a great degree and would be considered
mobile in the soil, based on its estimated Koc.
12.5 Results of PBT and vPvB Not performed.
assessment
12.6 Other toxic effects: Not available.
National laws on disposal must be considered, local and UE requirements for wastes recycling must be respected.
13.1 Waste treatment methods
Used waste product, surplus product or spillage products shall be disposed of in accordance with national, state and local laws.
Not classified in accordance with ADR/RID, IMDG, IATA and DOT regulations.
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU Regulations
●
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of
workers at work (Official Journal L 183 , 29/06/1989 P. 0001 – 0008) and following amendment and National reinforcements.
●
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to the personal
protective equipment.
●
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical
agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Official Journal L 131 ,
05/05/1998 P. 0011 – 0023.
●
Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
●
Commission Regulation (EU) 2015/830 of 28 May 2015 amending Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
●
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December on classification, labelling and packaging
of substances and mixtures 2008 (and subsequent amendments and supplements).
Restriction of use: none
Substance(s) under authorization: none
US Federal Regulations:
State Components listed Note
Massachusetts Formaldehyde Carcinogen, Extraordinarily hazardous
New York Formaldehyde No note
1,2-dibromo-2,4-dicyanobutane No note
New Jersey
Formaldehyde Carcinogen, Corrosive, Mutagen, Flammable - Fourth Degree
Environmental hazard
Pennsylvania Formaldehyde
Special hazardous substance
California Prop. 65
Ingredient name Cancer Reproductive NSRL or MADL (µg/day)
Formaldehyde cancer - 40
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WEEL: Workplace Environmental Exposure Level (air concentration of agents in a healthy worker's
breathing zone)
Information related to the Regulation EC/1272/2008:
Hazard statement(s): H301: Toxic if swallowed.
H311: Toxic in contact with skin.
H331: Toxic if inhaled.
H314: Causes severe skin burns and eye damage.
H315: Causes skin irritation.
H317: May cause an allergic skin reaction.
H318: Causes serious eye damage.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
H341: Suspected of causing genetic defects
H350: May cause cancer.
H400: Very toxic to aquatic life.
Information on workers training: Follow National requirements to ensure protection of human health and the environment.
Classification and procedure used to derive the classification for mixtures according to Regulation (EC) 1272/2008,
according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to HPR (WHMIS 2015) :
Classification: Classification procedure
Not classified -
The contained information in this SDS are in accordance with Annex II of the COMMISSION REGULATION (EU) No
1907/2006 (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29
CFR 1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation
HPR (WHMIS 2015) as recommended by Health Canada (HC).
Bibliographic references:
(1)
GESTIS International Limit Values, available on http://limitvalue.ifa.dguv.de/WebForm_ueliste.aspx
(2)
ACGIH, TLVs and BEIs based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents &
Biological Exposure Indices, 2012
(3)
Formaldehyde, Registration Dossier on ECHA, available at http://apps.echa.europa.eu/registered/data/dossiers/DISS-9daa7594-c409-0ed0-
e044-00144f67d249/AGGR-3c0fcb62-7d2d-4fac-ba94-193b313f447b_DISS-9daa7594-c409-0ed0-e044-00144f67d249.html#AGGR-3c0fcb62-
7d2d-4fac-ba94-193b313f447b
(4)
Gestis Substance database, Formaldehyde, ZVG 10520
(5)
ChemIdplus Lite, Formaldehyde, full record
(6)
Priority Existing Chemical Assessment Report No. 28, Formaldehyde, November 2006, National Industrial Chemicals Notification and
Assessment Scheme
(7)
SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of the use of formaldehyde in nail hardeners,
SCCS/1538/14, written procedure 7 November 2014, revision of 16 December 2014.
(8)
Committee for Risk Assessment RAC, Opinion proposing harmonized classification and labeling at EU level of Formaldehyde
EC number: 200-001-8, CAS number: 50-00-0, CLH-O-0000003155-80-01/F, Adopted 30 November 2012
(9)
SIDS Initial Assessment Report For SIAM 14 Paris, France, March 2002, Formaldehyde
(10)
Australian Government, Department of Health and Ageing, NICNAS Existing Chemicals Information Sheet, Methyldibromo
Glutaronitrile, June 2009
(11)
NTP Nomination History and Review, 1,2-dibromo-2,4-dicyanobutane, CAS No. 35691-65-7
(12)
LANXESS, Material Safety Data Sheet for Tektamer 38LV
(13)
Gestis Substance database, 1,2-Dibromo-2,4-dicyanobutane, ZVG 139996
(14)
EPA R.E.D. Facts, DIBROMODICYANOBUTANE
(15)
SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS, SCCP, Opinion on Methyldibromo glutaronitrile (sensitization only), COLIPA n°
P77, Adopted by the SCCP during the 3rd plenary meeting of 15 March 2005
(16)
HSDB: 1,2-DIBROMO-2,4-DICYANOBUTANE, available at http://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~tRCfcl:1
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According to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and
according to Hazardous Product Regulation HPR (WHMIS 2015):
Hazard class Hazard category Hazard statement
Not classified
For exposure limits see section 8.
Potential adverse physicochemical, human health and environmental effects (see also ch. 9-12)
Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment.
2.2 Label elements, according to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR
1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015):
Safety precautions: Use the product in accordance with the Good Laboratory Practice.
Wear suitable protective clothing, gloves and eye/face protection.
Do not let the product enter drainage system, surface and ground-water or soil. Do not empty into drains.
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Classification
EINECS/ Conc. % Classification
Name CAS n° 29 CFR 1910.1200 (HCS)
ELINCS n° w/w* 1272/2008/EC
HPR (WHMIS 2015)
Calcium chloride dihydrate 233-140-8 10035-04-8 < 0.4 % Eye damage/irritation, cat. 2 Eye Irrit. 2, H319
Index N. (Annex VI of CLP Reg.): (as Calcium (10043-52-4
017-013-00-2 chloride as Calcium
anhydrous) chloride anhydr.)
Sodium azide 247-852-1 26628-22-8 < 0.03 % Acute Toxicity – Oral, cat. 2 Acute Tox. 2, H300
Index N. (Annex VI of CLP Reg.): Aquatic Acute, cat 1** Aquatic Acute 1, H400
011-004-00-7 Aquatic Chronic, cat. 1** (M=1)
Aquatic Chronic 1, H410
(M=1)
For exposure limits see ch. 8, for hazard statements text see ch. 16.
* a range may be indicated, considering batch-to batch variation.
**Environmental classification according to Reg. N. 1272/2008 (EC) and subsequent amendments.
The mixture contains one substance listed in the Hazardous Substance Lists and/or evaluated for carcinogenicity by IARC, NTP, OSHA:
sodium azide. See Section 11 and 15.
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7.1 Precautions for safe handling Handle in a well ventilated place, and away from sparkles and flames - sources of ignition. Keep the
mixture away from drains, surface or ground waters. Avoid contact with incompatible materials. Wear
suitable Personal Protection Equipment (see section 8).
Do not eat, drink and smoke in the working areas. Wash hands with soap and water after handling
the mixture. Remove contaminated clothing and protective equipment before entering eating areas.
7.2 Conditions for safe storage, Recommended temperature: store at 2-8°C.Avoid light exposure and keep away from heat sources.
incompatibilities Room ventilation: well ventilated workplace. Keep containers tightly closed and labelled with the name
of the product. Avoid environmental release.
Keep away from food and drinks. Keep away from contamination with heavy metals. Sodium azide has
been reported to form lead or copper azide in laboratory plumbing which may explode on percussion.
7.3 Specific end use SCT CaCl2 is intended for in vitro diagnostic use. Use the product in accordance with the Good
Laboratory Practice.
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10.1 Reactivity This mixture is considered not reactive under the normal conditions of the usage.
10.2 Chemical stability The product is stable until the expiration date shown on the box and on the labels when stored at 2 –
8°C.
10.3 Possibility of hazardous Not foreseen.
reactions
10.4 Conditions to avoid: Keep out from heat and light.
10.5 Incompatible materials Oxidizing agents, reducing agents, strong acid agents, and strong basic agents. Keep away from acids
(sodium azide reacts strongly) and away from contamination with heavy metals. Sodium azide has
been reported to form lead or copper azide in laboratory plumbing which may explode on
percussions. Sodium azide reacts vigorously with heated water.
10.6 Hazardous decomposition Thermal decomposition or combustion may include toxic and hazardous fumes of COx, NOx, Na2O,
products: HBr, HCl.
The health effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are provided
bellow.
11.1 Information on toxicological effects
Symptoms and effects for each route of exposure:
Dermal: Prolonged or repeated skin contact may cause irritation.
Ingestion: Ingestion may cause irritation to the gastrointestinal mucous membranes.
Inhalation: Inhalation of the product may cause irritation to respiratory ways.
Contact with eyes: May cause irritation.
Toxicokinetic effects (Absorption, Distribution, Metabolism, Excretion):
Calcium chloride : is easily dissociated into calcium and chloride ions in water. The absorption, the distribution and the excretion of the
(1)
ions in animals are regulated separately. Both ions are essential constituents of the body of all animals.
Sodium azide is rapidly absorbed from the respiratory and gastrointestinal tract, and from injection sites. It is also rapidly absorbed by
the lungs, and through the skin. The degree of skin penetration via undamaged skin is not clear. The azide anion appeared within 5 min
in the plasma of rats following oral administration of 40 mg/kg sodium azide. After 24 h, no more azide could be detected in either
plasma or tissue. Sodium azide penetrates the blood-brain barrier and is mainly metabolized in the liver. Its main metabolite in the liver
is nitric oxide. Azide anions may be metabolized to nitric oxide (NO) also in the CNS. In aqueous solution, it rapidly transforms into
hydrazoic acid, which may be responsible for the irritating effects attributed to sodium azide. Following oral administration of 40 mg/kg
sodium azide, no sodium azide was detectable in the feces or in exhaled air and only 7.9 μg were excreted in the 24 h urine.(6)(7)(8)
Acute toxicity Value m.u. Effects Related to
(1)
Oral: LD50 (rat) =3,798 - 4,179 mg/Kg The acute oral toxicity is attributed Calcium chloride
LD50 (rabbit)=500 – 1,000 to the severe irritating property of
the original substance or its high-
concentration solutions to the
gastrointestinal tract.
(9)
LD50 (rat) = 27 mg/kg Sodium azide
(1)
Dermal: LD50 (rabbit) > 5,000 mg/Kg Calcium chloride
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(7)
In the study of Potocar et al. (1985), 3 surviving animals were exposed to 500- Sodium azide
1000 mg/kg sodium azide for 1 hour and then to half of that dose for three
additional hours on their skins. These data do not support the dermal lethal
dose (LD) of sodium azide for rabbits of 18-21 mg/kg, based on a
Bassendowska and Kowalski (1961) dermal irritation study, where a single
rabbit, exposed to 60 mg substance via the skin, died after 6 hours. Not
classified in accordance with the opinion of the European scientific committee.
Inhalation: LC50 (rat) > 40 mg/m3/4h (1)
Calcium chloride
3 (9)
LC50 (rat) = 37 mg/m Sodium azide
Other data: The most commonly reported health effect from azide exposure is hypotension, almost independent of
route of exposure. Fatal doses occur with exposures of > or =700 mg (10 mg/kg). Nonlethal doses
ranged from 0.3 to 150 mg (0.004 to 2 mg/kg). Onset of hypotension within minutes or in less than an
hour is indicative of a pharmacological response and a benign course. Hypotension with late onset (>1
hour) constitutes an ominous sign for death.(10)
Corrosion/Irritation
Skin Corrosion/Irritation Calcium chloride is not irritating for the skin. (1)
Sodium azide: Dermal (semi-occlusive and occlusive) exposure to 0.5 g/patch solid sodium azide for 1
hour did not produce signs of local irritation in rabbits, whereas exposure for 4 hours was corrosive. .(7)
In an in vitro Skin Irritation Reconstructed Human Epidermis (RhE) Test Method (9 September 2009),
sodium azide was nonirritant to skin. (8) Non classified in accordance with the opinion of the European
scientific committee.
(1)
Serious eye damage/ irritation Calcium chloride is irritating for the eyes.
Sodium azide: In a Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular
(8)
Corrosives and Severe Irritants (September, 2009) was not considered to be an eye irritant.
Sensitization:
Skin sensitization: Calcium chloride: Due to lack of data the classification is not possible.
Sodium azide: In a Mouse local lymphnode assay (LLNA) (OECD Guideline 429), sodium azide was not
(8)
a skin sensitizer.
Respiratory sensitization: Not available.
CMR effects
Germ cell mutagenicity; Calcium chloride: Genetic toxicity of calcium chloride was negative in the bacterial mutation tests and
(1)
the mammalian chromosome aberration test.
Sodium azide : is highly mutagenic in many plant and bacterial species but marginally mutagenic in
mammalian cells. Sodium azide was mutagenic in Salmonella typhimurium strains TA100 and TA1535
with or without exogenous metabolic activation (S9); it was not mutagenic in strain TA1537 or TA98.
Mutagenicity as observed in bacteria is not relevant for mammals, because of the specific metabolism of
sodium azide in bacteria. The existing data support the conclusion that azide may be further modified in
mammalian cells to an intermediate that is not genotoxic. (7)(11) Negative in a Chromosomal aberration
test. In a Cytogenetic tests with Chinese hamster ovary cells, Sodium azide induced sister chromatid
exchanges, but not chromosomal aberrations. (12) No studies in mammals are available to adequately
assess germ cell effects. (9)
Reproductive toxicity: Calcium chloride: No reproductive toxicity study has been reported. A developmental toxicity study
equivalent to an OECD Guideline Study reveals no toxic effects on dams or fetuses at doses up to 189
mg/kg bw/day (mice), 176 mg/kg bw/day (rats) and 169 mg/kg bw/day (rabbits). (1)
Sodium azide: Insufficient data are available for an assessment of the reproductive toxicity.(14)
Carcinogenesis: Substances listed in the National Toxicology Program (NTP) Report on Carcinogens, in the International
Agency for Research on Cancer (IARC) Monographs or found to be potential carcinogen by OSHA:
Substance OSHA IARC NTP
No component listed
Sodium azide: Two long-term oral studies in rats provided no convincing evidence of carcinogenicity,
although in both cases the suitability of the test doses has been questioned. At concentrations of 5 and
10 mg/kg sodium azide there was no evidence of carcinogenicity in rats during a 2-year study.(13)
STOT –single exposure Sodium azide is not an irritant but is rapidly hydrolysed to hydrazoic acid in the acidic environment of
mucous membranes and the tracheobronchial tree. (7) Hydrazoic acid vapor in concentrations of 0.5
ml/m3 (0.9 mg/m3) or more caused irritation of the nasal mucosa. Irritation of the conjunctiva has also
been described. (14) Non classified in accordance with the opinion of the European scientific committee.
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STOT – repeated exposure Calcium chloride: A study for repeated dose oral toxicity in rats shows no adverse effect of calcium
chloride on rats fed 20 mg CaCl2/g diet (comparable to 1000 mg/kg bw/day or more) for 12 months.(1)
Sodium azide: Repeated oral administration caused brain and lung damage in rats, but no such effects
have apparently been seen in a corresponding mouse study.(13) Non classified in accordance with the
opinion of the European scientific committee.
Aspiration hazards Not available.
Other information: The occupational neuropsychotoxicology of sodium azide was investigated annually, for three years in
41 sodium azide exposed workers in a chemical production plant, compared to 42 unexposed ones
working in the same plant. Exposed workers presented significantly more acute symptoms of exposure
than unexposed workers. Symptoms reported included headache, vertigo, nausea, fatigue, cardiac
palpitations, irritated or red eyes. The only recurring chronic symptom was trembling of the hands. No
psychological or neuropsychological tests differentiated the exposed from the unexposed group. (7)
Reasons for the lack of classification:
Where the mixture resulted in a non-classification, this may be due to the availability of data which does not impose a classification for
that specific end-point, or due to lack of data, or due to availability of inconclusive data or data which are not sufficient to get a
classification as for the criteria adopted in Regulations mentioned in this data sheet.
The environmental effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are
provided bellow.
12.1 Toxicity species, media, units, test duration and test conditions. Related to
(1)
Acute toxicity with fish: LC50 Pimephales promelas= 4,630 mg/l/96 hours Calcium chloride
(6)
LC50 Lepomis macrochirus = 0.7 mg/l/96 hours Sodium azide
Chronic toxicity with fish: Not available
(1)
Acute toxicity with crustaceans: EC50 Daphnia magna = 1062 mg/L/48 hr Calcium chloride
(6)
EC50 Daphnia pulex = 4.2 mg/l/96 hours Sodium azide
(1)
Chronic toxicity with The chronic toxicity study with Daphnia magna shows that a 16% impairment Calcium chloride
crustaceans: of reproduction (EC16) is caused at the concentration of 320 mg/L.
(1)
Acute toxicity with algae: EC50 Selenastrum capricornutum = 2900 mg/L/72 hours (biomass) Calcium chloride
(8)
Chronic toxicity with algae: EC50 Pseudokirchneriella = 0.35 mg/l/96 hours Sodium azide
Toxicity data on soil micro- and Not available.
macroorganisms
(8)
Toxicity data on birds, bees and In a bioassay comparable to OECD guideline 208 with slight restrictions, 10 Sodium azide
plants: ppm sodium azide in the soil significantly reduced germination and growth in
plant species tested, whereas the growth was mostly affected at
concentrations above 5 ppm, exhibiting a delay in plant germination. After
dissipation of sodium azide normal growth proceeded.
12.2 Persistency and Once emitted into the environment, calcium chloride, which has a high water solubility, will dissociate
degradability: into the calcium cation and the chloride anion. The calcium ion may bind to soil particulate or may
form stable inorganic salts with sulphate and carbonate ions.
12.3 Bioaccumulation potential: Considering its dissociation properties, Calcium chloride per se is not expected to accumulate in living
organisms.
12.4 Mobility in soil: The dissipation of azides in soil is not by microbial action but is strictly a chemical process accelerated
by increasing acidity and elevated temperatures. (10)
The chloride ion is mobile in soil and eventually drains into surface water because it is readily dissolved
in water.
12.5 Results of PBT and vPvB Not available.
assessment
12.6 Other toxic effects: Not available.
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SAFETY DATA SHEET Doc. ID: SDS00020004800_EN
SCT CaCl2 Revision: 02
CO: 460053
Edited on: 11/10/2015
National laws on disposal must be considered, local and UE requirements for wastes recycling must be respected.
13.1 Waste treatment methods
Used waste product, surplus product or spillage products shall be disposed of in accordance with national, state and local laws.
Not classified in accordance with ADR/RID, IMDG, IATA and DOT regulations.
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU Regulations
●
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of
workers at work (Official Journal L 183 , 29/06/1989 P. 0001 – 0008) and following amendment and National reinforcements.
●
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to the personal
protective equipment.
●
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical
agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Official Journal L 131 ,
05/05/1998 P. 0011 – 0023.
●
Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
●
Commission Regulation (EU) 2015/830 of 28 May 2015 amending Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
●
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December on classification, labelling and packaging
of substances and mixtures 2008 (and subsequent amendments and supplements).
Restriction of use: none
Substance(s) under authorization: none
US Federal Regulations:
State Components listed Note
Massachusetts Sodium azide Extraordinarily hazardous
New York Sodium azide A – acutely hazardous substances
New Jersey Sodium azide -
Pennsylvania Sodium azide E - Substance is on the Environmental Hazard List
California Prop. 65
Ingredient name Cancer Reproductive NSRL or MADL (µg/day)
No component listed
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SAFETY DATA SHEET Doc. ID: SDS00020004800_EN
SCT CaCl2 Revision: 02
CO: 460053
Edited on: 11/10/2015
15.2 Chemical safety assessment: A chemical safety assessment has not been carried out for the mixture by the supplier.
The contained information in this SDS are in accordance with Annex II of the COMMISSION REGULATION (EU) No
1907/2006 (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29 CFR
1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation HPR
(WHMIS 2015) as recommended by Health Canada (HC).
Page 30 of 31
SAFETY DATA SHEET Doc. ID: SDS00020004800_EN
SCT CaCl2 Revision: 02
CO: 460053
Edited on: 11/10/2015
Bibliographic references:
(1)
Calcium Chloride, SIDS Initial Assessment Report For SIAM 15 Boston, USA 22-25th October 2002
(2)
Calcium chloride anh., Registration dossier, available at: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb43f6f-23a1-
5205-e044-00144f67d031/AGGR-dc2ba8fd-c7fc-402e-906e-b6cd0864ad5e_DISS-9eb43f6f-23a1-5205-e044-
00144f67d031.html#AGGR-dc2ba8fd-c7fc-402e-906e-b6cd0864ad5e
(3)
International Chemical Safety Cards, Sodium azide
(4)
GESTIS International Limit Values, available on http://limitvalue.ifa.dguv.de/WebForm_ueliste.aspx
(5)
ACGIH, TLVs and BEIs based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents &
Biological Exposure Indices, 2012
(6)
HSDB Hazardous Substances Databank, Sodium azide
(7)
Recommendation from the Scientific Committee on Occupational Exposure Limits for sodium azide, SCOEL/SUM/51,September 2009
(8)
http://apps.echa.europa.eu/registered/data/dossiers, Sodium azide
(9)
ChemIDplus Lite, Sodium azide, full record
(10)
http://www.ncbi.nlm.nih.gov/pubmed/12851150, Human health effects of sodium azide exposure: a literature review and analysis.
Int J Toxicol. 2003 May-Jun;22(6):175-86.
(11)
http://www.ncbi.nlm.nih.gov/pubmed/2671718, Sodium azide mutagenesis in mammals: inability of mammalian cells to convert
azide to a mutagenic intermediate. Arenaz P1, Hallberg L, Mancillas F, Gutierrez G, Garcia S.
(12)
National Toxicology Program database Search Application, Toxicology and Carcinogenesis Studies of Sodium azide (CAS: 26628-22-
8) in F344 Rats (Gavage Studies)
(13)
http://www.bibra-information.co.uk/downloads/toxicity-profile-for-sodium-azide-1992/, Toxicity Profile for Sodium azide (1992)
(14)
http://onlinelibrary.wiley.com, The MAK Collection for Occupational Health and Safety, Sodium azide
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