MATERIAL SAFETY DATA SHEET

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

Pfizer Inc Pfizer Ltd

Pfizer Pharmaceuticals Group Ramsgate Road
235 East 42nd Street Sandwich, Kent
New York, New York 10017 CT13 9NJ
1-212-573-2222 United Kingdom
+00 44 (0)1304 616161
Emergency telephone number: Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300 ChemSafe (24 hours): +44 (0)208 762 8322
Contact E-Mail: pfizer-MSDS@pfizer.com

Material Name: Clopidogrel Tablets

Trade Name: Not applicable
Chemical Family: Not determined
Intended Use: Pharmaceutical product used as anticoagulant agent

2. HAZARDS IDENTIFICATION

Appearance: Pink film-coated tablet

Signal Word: DANGER

Statement of Hazard: Causes severe skin burns and eye damage.

Toxic to aquatic life with long lasting effects.

Additional Hazard Information:

Known Clinical Effects: Adverse effects associated with therapeutic use include gastrointestinal bleeding,
gastrointestinal disturbances, nausea, diarrhea, bleeding, discoloration of skin, fever, pain,
swelling, dizziness, difficulty breathing.
EU Classification
EU Indication of danger: Corrosive
Dangerous for the Environment

EU Hazard Symbols:

EU Risk Phrases:
R34 - Causes burns.
R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic
environment.
Australian Hazard Classification Hazardous Substance. Non-Dangerous Goods.
(NOHSC):

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2. HAZARDS IDENTIFICATION
Note: 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.

3. COMPOSITION/INFORMATION ON INGREDIENTS

Hazardous
Ingredient CAS Number EU EINECS/ELINCS List EU Classification %
Clopidogrel bisulfate 120202-66-6 Not Listed C,R34; N,R51/53 38
Microcrystalline cellulose 9004-34-6 232-674-9 Not Listed *
Silicon dioxide, colloidal NF 7631-86-9 231-545-4 Not Listed *

Ingredient CAS Number EU EINECS/ELINCS List EU Classification %

Mannitol 69-65-8 200-711-8 Not Listed *
Lactose NF, anhydrous 63-42-3 200-559-2 Not Listed *
Tablet coating NOT ASSIGNED Not Listed Not Listed *
Butylated hydroxyanisole 25013-16-5 246-563-8 Not Listed *
Croscarmellose sodium 74811-65-7 Not Listed Not Listed *
Sodium stearyl fumarate 4070-80-8 223-781-1 Not Listed *

Additional Information: * Proprietary

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: Formation of toxic gases is possible during heating or fire.

Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self-
contained breathing apparatus.
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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.

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

Additional Consideration for Large Non-essential personnel should be evacuated from affected area. Report emergency
Spills: situations immediately. Clean up operations should only be undertaken by trained personnel.

7. HANDLING AND STORAGE

General Handling: 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 thoroughly after handling.
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. Refer to Section 12 - Ecological
Information, for information on potential effects on the environment.
Storage Conditions: Store as directed by product packaging.

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Refer to available public information for specific member state Occupational Exposure Limits.

Microcrystalline cellulose
ACGIH Threshold Limit Value (TWA) 10 mg/m3 TWA
Australia TWA 10 mg/m3
Belgium OEL - TWA Listed
Estonia OEL - TWA Listed
France OEL - TWA Listed
Ireland OEL - TWAs Listed
Latvia OEL - TWA Listed
OSHA - Final PELS - TWAs: 15 mg/m3 total
5 mg/m3
Portugal OEL - TWA Listed
Romania OEL - TWA Listed
Spain OEL - TWA Listed

Silicon dioxide, colloidal NF

Australia TWA 2 mg/m3
Austria OEL - MAKs Listed
Czech Republic OEL - TWA Listed
Estonia OEL - TWA Listed
Germany - TRGS 900 - TWAs 4 mg/m3
Germany (DFG) - MAK 4 mg/m3 MAK

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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Ireland OEL - TWAs Listed
Latvia OEL - TWA Listed
OSHA - Final PELs - Table Z-3 Mineral D: - (80)/(% SiO2) mg/m3 TWA
TWA-20 mppcf
Slovenia OEL - TWA Listed

Clopidogrel bisulfate
Pfizer Occupational Exposure OEB 3 (control exposure to the range of >10ug/m3 to < 100ug/m3)
Band (OEB):

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.
Environmental Exposure Controls: Refer to specific Member State legislation for requirements under Community environmental
legislation.
Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personal
protective equipment (PPE).

Hands: Impervious gloves are recommended if skin contact with drug product is possible and for bulk
processing operations.
Eyes: Wear safety glasses or goggles if eye contact is possible.
Skin: Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations.
Respiratory protection: If airborne exposures are within or exceed the Occupational Exposure Band (OEB) range, wear
an appropriate respirator with a protection factor sufficient to control exposures to the bottom of
the OEB range.

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical State: Film-coated tablets Color: Pink

Molecular Formula: Mixture Molecular Weight: Mixture

10. STABILITY AND REACTIVITY

Chemical Stability: Stable under normal conditions of use.

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

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)

Clopidogrel bisulfate
Rat Oral LD50 2423 mg/kg
Mouse Oral LD50 2491 mg/kg

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11. TOXICOLOGICAL INFORMATION

Mannitol
Rat Oral LD 50 13500 mg/kg
Mouse Oral LD 50 22 g/kg

Butylated hydroxyanisole
Rat Oral LD50 2000 mg/kg
Mouse Oral LD 50 1100 mg/kg
Rat Intraperitoneal LD 50 881 mg/kg

Microcrystalline cellulose
Rat Oral LD50 > 5000 mg/kg
Rabbit Dermal LD50 > 2000 mg/kg
Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable
at the highest dose used in the test.

Irritation / Sensitization: (Study Type, Species, Severity)

Clopidogrel bisulfate
Eye Irritation Rabbit Severe
Skin Irritation Rabbit Corrosive

Microcrystalline cellulose
Skin Irritation Rabbit Non-irritating
Eye Irritation Rabbit Non-irritating

Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)

Clopidogrel bisulfate
3 Month(s) Rat Oral 400 mg/kg/day NOAEL No effects at maximum dose
3 Month(s) Mouse Oral 400 mg/kg/day LOAEL Liver
1 Year(s) Rat Oral 35 mg/kg/day NOAEL Liver
1 Year(s) Monkey Oral 65 mg/kg/day NOAEL Gastrointestinal system, Liver

Butylated hydroxyanisole
12 Day(s) Rat Oral 3300 mg/kg LOAEL Liver, Blood

Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))

Clopidogrel bisulfate
Fertility and Embryonic Development Rat Oral 100 mg/kg/day NOAEL No effects at maximum dose
Embryo / Fetal Development Rat Oral 120 mg/kg/day NOAEL No effects at maximum dose
Embryo / Fetal Development Rabbit Oral 100 mg/kg/day NOAEL Maternal Toxicity
Peri-/Postnatal Development Rat Oral 25 mg/kg/day NOAEL Maternal Toxicity

Butylated hydroxyanisole
Embryo / Fetal Development Rat Oral 30 g/kg LOEL Teratogenic

Genetic Toxicity: (Study Type, Cell Type/Organism, Result)

Clopidogrel bisulfate
In Vitro Bacterial Mutagenicity (Ames) Salmonella , E. coli Negative
In Vitro Chromosome Aberration Not specified Negative

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11. TOXICOLOGICAL INFORMATION

In Vitro Forward Mutation Assay Not specified Negative
In Vivo Micronucleus Mouse Negative

Butylated hydroxyanisole
In Vivo Micronucleus Bone Marrow Negative
In Vitro Bacterial Mutagenicity (Ames) Salmonella Negative

Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))

Clopidogrel bisulfate
2 Year(s) Rat Oral 100 mg/kg/day NOAEL Not carcinogenic
78 Week(s) Mouse Oral 100 mg/kg/day NOAEL Not carcinogenic

Butylated hydroxyanisole
Two Year(s) Rat Oral 728 g/kg/day Gastrointestinal system, Tumors
Two Year(s) Rat Oral 874 g/kg/day Gastrointestinal system, Endocrine system, Tumors

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

Silicon dioxide, colloidal NF

IARC: Group 3

Butylated hydroxyanisole
IARC: Group 2B
NTP: Listed
OSHA: Present

12. ECOLOGICAL INFORMATION

Environmental Overview: Toxic to aquatic organisms. May cause long term adverse effects in the aquatic environment.
Releases to the environment should be avoided.
Mobility, Persistence and Not readily biodegradable ( 4.07 % after 28 days). (Clopidogrel)
Degradability:
Aquatic Toxicity: (Species, Method, End Point, Duration, Result)

Clopidogrel bisulfate
Daphnia magna (Water Flea) EC50 48 Hours 8.3 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.

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15. REGULATORY INFORMATION

EU Indication of danger: Corrosive

Dangerous for the Environment

EU Risk Phrases:
R34 - Causes burns.
R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic
environment.

OSHA Label:
DANGER
Causes severe skin burns and eye damage.
Toxic to aquatic life with long lasting effects.

Canada - WHMIS: Classifications

WHMIS hazard class:
Class D, Division 2, Subdivision B
Class E

Mannitol
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
REACH - Annex IV - Exemptions from the Present
obligations of Register:
EU EINECS/ELINCS List 200-711-8

Lactose NF, anhydrous

Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
EU EINECS/ELINCS List 200-559-2

Microcrystalline cellulose
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
EU EINECS/ELINCS List 232-674-9

Butylated hydroxyanisole

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15. REGULATORY INFORMATION

California Proposition 65 carcinogen, initial date 1/1/90
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
EU EINECS/ELINCS List 246-563-8

Croscarmellose sodium
Australia (AICS): Listed

Sodium stearyl fumarate

EU EINECS/ELINCS List 223-781-1

Silicon dioxide, colloidal NF

Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
EU EINECS/ELINCS List 231-545-4

16. OTHER INFORMATION

Text of R phrases mentioned in Section 3

R34 - Causes burns.

R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Data Sources: Publicly available toxicity information.

Prepared by: Product Stewardship Hazard Communications

Pfizer Global Environment, Health, and Safety Operations

Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it
is without 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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