MATERIAL SAFETY DATA SHEET

Revision date: 08-Nov-2012

Version: 1.2

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1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING

Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300

Greenstone LLC
100 Route 206 North
Peapack, NJ 07977
800-435-7095

Material Name: Lisinopril Tablets (Greenstone LLC)

Trade Name:
Synonyms:
Chemical Family:
Intended Use:

Not applicable
None
Angiotensin converting enzyme inhibitor
Antihypertensive

2. HAZARDS IDENTIFICATION
Appearance:
Signal Word:

White, yellow, or pink tablet

WARNING

Statement of Hazard:

Suspected of damaging the unborn child.

Additional Hazard Information:

Short Term:

Antihypertensive drug: has blood pressure-lowering properties

Long Term:

Known Clinical Effects:

EU Indication of danger:

Animal studies have shown a potential to cause adverse effects on the fetus. In humans, the
use of drugs in this class (ACE inhibitors) can cause fetal and neonatal toxicity, including low
blood pressure and kidney failure, when they are taken during the second and third trimesters
of pregnancy.
Adverse effects most commonly reported in clinical use include dizziness, nausea, headache,
anxiety, drowsiness. Due to intended use, dangerous lowering of blood pressure can occur.
Toxic to Reproduction: Category 3

EU Hazard Symbols:

EU Risk Phrases:
Australian Hazard Classification
(NOHSC):
Note:

R63 - Possible risk of harm to the unborn child.

Hazardous Substance. Non-Dangerous Goods.

This document has been prepared in accordance with standards for workplace safety, which
require the inclusion of all known hazards of the active substance or its intermediates
regardless of the potential risk. The precautionary statements and warnings included may not
apply in all cases. Your needs may vary depending upon the potential for exposure in your
workplace.

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3. COMPOSITION/INFORMATION ON INGREDIENTS
Hazardous
Ingredient
Lisinopril
Starch, pregelatinized
Ferric oxide red
Corn Starch
Ferric oxide yellow
Magnesium stearate

CAS Number
83915-83-7
9005-25-8
1309-37-1
9005-25-8
51274-00-1
557-04-0

EU EINECS/ELINCS List EU Classification

Not Listed
Repr.Cat.3;R63
232-679-6
Not Listed
215-168-2
Not Listed
232-679-6
Not Listed
257-098-5
Not Listed
209-150-3
Not Listed

%
2-15
*
*
*
*
*

Ingredient
Dibasic Potassium Phosphate
Mannitol

CAS Number
7758-11-4
69-65-8

EU EINECS/ELINCS List EU Classification

231-834-5
Not Listed
200-711-8
Not Listed

%
*
*

Additional Information:

*** per tablet/capsule/lozenge/suppository

Ingredient(s) indicated as hazardous have been assessed under standards for workplace
safety.

For the full text of the R phrases mentioned in this Section, see Section 16

4. FIRST AID MEASURES

Eye Contact:

Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.

Skin Contact:

Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek
medical attention.

Ingestion:

Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not
induce vomiting unless directed by medical personnel. Seek medical attention immediately.

Inhalation:

Remove to fresh air and keep patient at rest. Seek medical attention immediately.

Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards
Identification and/or Section 11 - Toxicological Information.

5. FIRE FIGHTING MEASURES

Extinguishing Media:

Use carbon dioxide, dry chemical, or water spray.

Hazardous Combustion Products:

Carbon monoxide, carbon dioxide, and oxides of nitrogen may be generated in a fire.

Fire Fighting Procedures:

During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus.

Fire / Explosion Hazards:

Fine particles (such as dust and mists) may fuel fires/explosions.

6. ACCIDENTAL RELEASE MEASURES

Health and Safety Precautions:

Personnel involved in clean-up should wear appropriate personal protective equipment (see
Section 8). Minimize exposure.

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Measures for Cleaning / Collecting:

Contain the source of spill if it is safe to do so. Collect spilled material by a method that
controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of
dry solids. Clean spill area thoroughly.

Measures for Environmental

Protections:

Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
avoid environmental release.

Additional Consideration for Large

Spills:

Non-essential personnel should be evacuated from affected area. Report emergency

situations immediately. Clean up operations should only be undertaken by trained personnel.

7. HANDLING AND STORAGE

General Handling:

Storage Conditions:

Minimize dust generation and accumulation. If tablets or capsules are crushed and/or broken,
avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, use
appropriate personal protective equipment (see Section 8). Wash hands and any exposed skin
after removal of PPE. Review and implement appropriate technical and procedural waste water
and waste disposal measures to prevent occupational exposure or environmental releases.
Potential points of process emissions of this material to the atmosphere should be controlled
with dust collectors, HEPA filtration systems or other equivalent controls. Releases to the
environment should be avoided.
Store as directed by product packaging.

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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Refer to available public information for specific member state Occupational Exposure Limits.
Starch, pregelatinized
ACGIH Threshold Limit Value (TWA)
Australia TWA
Belgium OEL - TWA
Bulgaria OEL - TWA
Czech Republic OEL - TWA
Greece OEL - TWA
Ireland OEL - TWAs
OSHA - Final PELS - TWAs:
Portugal OEL - TWA
Slovakia OEL - TWA
Spain OEL - TWA
Ferric oxide red
ACGIH Threshold Limit Value (TWA)
Australia TWA
Austria OEL - MAKs
Belgium OEL - TWA
Bulgaria OEL - TWA
Denmark OEL - TWA
Estonia OEL - TWA
Finland OEL - TWA
France OEL - TWA
Greece OEL - TWA
Hungary OEL - TWA
Ireland OEL - TWAs

Lithuania OEL - TWA

OSHA - Final PELS - TWAs:
Poland OEL - TWA
Portugal OEL - TWA
Romania OEL - TWA
Slovakia OEL - TWA
Spain OEL - TWA
Sweden OEL - TWAs
Corn Starch
ACGIH Threshold Limit Value (TWA)
Australia TWA
Belgium OEL - TWA
Bulgaria OEL - TWA
Czech Republic OEL - TWA
Greece OEL - TWA

10 mg/m3
10 mg/m3
10 mg/m3
10.0 mg/m3
4.0 mg/m3
10 mg/m3
5 mg/m3
10 mg/m3
4 mg/m3
15 mg/m3
10 mg/m3
4 mg/m3
10 mg/m3

5 mg/m3
5 mg/m3
10 mg/m3
5 mg/m3
10 mg/m3
2 ppm
5 mg/m3
5.0 mg/m3
3.5 mg/m3
3.5 mg/m3
5 mg/m3
5 mg/m3
10 mg/m3
6 mg/m3
5 mg/m3
10 mg/m3
4 mg/m3
3.5 mg/m3
10 mg/m3
5 mg/m3
5 mg/m3
5 mg/m3
1.5 mg/m3
5 mg/m3
3.5 mg/m3

10 mg/m3
10 mg/m3
10 mg/m3
10.0 mg/m3
4.0 mg/m3
10 mg/m3
5 mg/m3

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10 mg/m3
4 mg/m3
15 mg/m3
10 mg/m3
4 mg/m3
10 mg/m3

Ireland OEL - TWAs

OSHA - Final PELS - TWAs:
Portugal OEL - TWA
Slovakia OEL - TWA
Spain OEL - TWA
Magnesium stearate
ACGIH Threshold Limit Value (TWA)
Lithuania OEL - TWA
Sweden OEL - TWAs

10 mg/m3
5 mg/m3
5 mg/m3

Manufacturer OEB Statement:

The purpose of the Occupational Exposure Band (OEB) classification system is to separate
substances into different Hazard categories when the available data are sufficient to do so, but
inadequate to establish an Occupational Exposure Limit (OEL). The OEB given is based upon
an analysis of all currently available data; as such, this value may be subject to revision when
new information becomes available.
Lisinopril
Manufacturer OEB:

OEB3 (control exposure to the range of >10ug/m3 to < 100ug/m3)

Engineering Controls:

Engineering controls should be used as the primary means to control exposures. General
room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne
contamination levels below the exposure limits listed above in this section.

Personal Protective Equipment:

Refer to applicable national standards and regulations in the selection and use of personal
protective equipment (PPE).
Impervious gloves are recommended if skin contact with drug product is possible and for bulk
processing operations.
Wear safety glasses or goggles if eye contact is possible.
Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations.
If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate
respirator with a protection factor sufficient to control exposures to below the OEL.

Hands:
Eyes:
Skin:
Respiratory protection:

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical State:
Molecular Formula:

Tablet
Mixture

Solubility:
Partition Coefficient
(Calculated - Log Pow/Log Kow):
Partition Coefficient
(Calculated; pH 7.4 - Log D):

Soluble: Water
1.18 (Lisinopril)

Color:
Molecular Weight:

White, yellow, or pink

Mixture

-1.41 (Lisinopril)

10. STABILITY AND REACTIVITY

Chemical Stability:
Conditions to Avoid:
Incompatible Materials:

Stable under normal conditions of use.

Fine particles (such as dust and mists) may fuel fires/explosions.
As a precautionary measure, keep away from strong oxidizers

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11. TOXICOLOGICAL INFORMATION

General Information:

The information included in this section describes the potential hazards of the individual
ingredients.

Acute Toxicity: (Species, Route, End Point, Dose)

Magnesium stearate
Rat
Oral
LD50
> 2000 mg/kg
Rat
Inhalation LC50
> 2000 mg/m3
Mannitol
Rat Oral LD 50
13500 mg/kg
Mouse Oral LD 50
22 g/kg
Lisinopril
Dog Oral LD50
> 6000 mg/kg
A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable
Acute Toxicity Comments:
at the highest dose used in the test.
Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))
Lisinopril
Reproductive & Fertility
Rat
No route specified 300 mg/kg/day
NOAEL
No effects at maximum dose
Embryo / Fetal Development
Rat
No route specified 188 times human dose
Not Teratogenic
Embryo / Fetal Development
Mouse
No route specified 625 times human dose
Not Teratogenic
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Lisinopril
In Vitro Bacterial Mutagenicity (Ames)
Salmonella
Negative
HGPRT Forward Gene Mutation Assay
Hamster Lung Cells
Negative
In Vitro Chromosome Aberration
Chinese Hamster Ovary (CHO) cells
Negative
In Vivo Chromosome Aberration
Mouse Bone Marrow
Negative
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Lisinopril
105 Week(s) Rat No route specified 90 mg/kg/day NOAEL Not carcinogenic
92 Week(s) Mouse No route specified 135 mg/kg/day NOAEL Not carcinogenic
Carcinogen Status:

None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.

Ferric oxide red

IARC:

Group 3 (Not Classifiable)

12. ECOLOGICAL INFORMATION

Environmental properties have not been thoroughly investigated. Releases to the environment
should be avoided.
1.18 (Lisinopril)
Partition Coefficient
(Calculated - Log Pow/Log Kow):
-1.41 (Lisinopril)
Partition Coefficient
(Calculated; pH 7.4 - Log D):

Environmental Overview:

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12. ECOLOGICAL INFORMATION

Aquatic Toxicity: (Species, Method, End Point, Duration, Result)
Lisinopril
Oncorhynchus mykiss (Rainbow Trout)

LC50

96 Hours

> 1060 mg/L

13. DISPOSAL CONSIDERATIONS

Waste Treatment Methods:

Dispose of waste in accordance with all applicable laws and regulations. Member State
specific and Community specific provisions must be considered. Considering the relevant
known environmental and human health hazards of the material, review and implement
appropriate technical and procedural waste water and waste disposal measures to prevent
occupational exposure and environmental release. It is recommended that waste minimization
be practiced. The best available technology should be utilized to prevent environmental
releases. This may include destructive techniques for waste and wastewater.

14. TRANSPORT INFORMATION

The following refers to all modes of transportation unless specified below.
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.

15. REGULATORY INFORMATION

EU Symbol:
EU Indication of danger:

Xn
Toxic to Reproduction: Category 3

EU Risk Phrases:
R63 - Possible risk of harm to the unborn child.
EU Safety Phrases:
S22 - Do not breathe dust.
S36/37 - Wear suitable protective clothing and gloves.
S53 - Avoid exposure - obtain special instructions before use.

OSHA Label:
WARNING
Suspected of damaging the unborn child.

Canada - WHMIS: Classifications

WHMIS hazard class:
Class D, Division 2, Subdivision A

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15. REGULATORY INFORMATION

Dibasic Potassium Phosphate
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List
Starch, pregelatinized
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
REACH - Annex IV - Exemptions from the
obligations of Register:
EU EINECS/ELINCS List
Ferric oxide red
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List
Corn Starch
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
REACH - Annex IV - Exemptions from the
obligations of Register:
EU EINECS/ELINCS List
Mannitol
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
REACH - Annex IV - Exemptions from the
obligations of Register:
EU EINECS/ELINCS List

Present
Present
231-834-5

Present
Present
Present
232-679-6

Present
Present
215-168-2

Present
Present
Present
232-679-6

Present
Present
Present
200-711-8

Ferric oxide yellow

Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List

Present
Present
257-098-5

Magnesium stearate
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List

Present
Present
209-150-3

16. OTHER INFORMATION

Text of R phrases mentioned in Section 3
R63 - Possible risk of harm to the unborn child.
Publicly available toxicity information.
Data Sources:
Reasons for Revision:

Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking.

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Prepared by:

Product Stewardship Hazard Communication

Global Environment, Health, and Safety Operations

It is believed that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is
without a warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known
information at this time
End of Safety Data Sheet

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