MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Clopidogrel TabletsTrade Name:Not applicableChemical Family:Not determinedIntended Use:Pharmaceutical product used as anticoagulant agent2. HAZARDS IDENTIFICATIONA ppearance:Pink film-coated tabletSignal Word:DANGERS tatement of Hazard:Causes severe skin burns and eye to aquatic life with long lasting 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 ClassificationEU Indication of danger:CorrosiveDangerous for the EnvironmentEU Hazard Symbols:EU Risk Phrases:R34 - Causes - Toxic to aquatic organisms, may cause long-term adverse effects in the Hazard Classification(NOHSC):Hazardous Substance.

2 Non-Dangerous LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 16-Jun-2011 Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322 Contact MATERIAL SAFETY data SHEETPage 1 of 8 Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222 MATERIAL SAFETY data SHEET_____2. HAZARDS IDENTIFICATIONNote:This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the active substance or its intermediatesregardless of the potential risk. The precautionary statements and warnings included may notapply in all cases. Your needs may vary depending upon the potential for exposure in COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS List EU Classification%Clopidogrel bisulfate120202-66-6 Not ListedC,R34.

3 N,R51/5338 Microcrystalline cellulose9004-34-6232-674-9 Not Listed*Silicon dioxide, colloidal NF7631-86-9231-545-4 Not Listed*IngredientCAS NumberEU EINECS/ELINCS List EU Classification%Mannitol69-65-8200-711-8 Not Listed*Lactose NF, anhydrous63-42-3200-559-2 Not Listed*Tablet coatingNOT ASSIGNEDNot ListedNot Listed*Butylated hydroxyanisole25013-16-5246-563-8 Not Listed*Croscarmellose sodium74811-65-7 Not ListedNot Listed*Sodium stearyl fumarate4070-80-8223-781-1 Not Listed*Additional Information:* ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for the full text of the R phrases mentioned in this Section, see Section 164. FIRST AID MEASURESEye Contact:Flush with water while holding eyelids open for at least 15 minutes.

4 Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical :Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention :Remove to fresh air and keep patient at rest. Seek medical attention and Effects of Exposure:For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological FIRE FIGHTING MEASURESE xtinguishing Media:Use carbon dioxide, dry chemical, or water Combustion Products:Formation of toxic gases is possible during heating or Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing date: 16-Jun-2011 MATERIAL Name: Clopidogrel TabletsVersion: 2 of 8 MATERIAL SAFETY data SHEET_____Fire / Explosion Hazards:Fine particles (such as dust and mists) may fuel ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions.

5 Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8). Minimize for Cleaning / Collecting:Contain the source of spill if it is safe to do so. Collect spilled MATERIAL by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area for EnvironmentalProtections:Place waste in an appropriately labeled, sealed container for disposal. Care should be taken toavoid environmental Consideration for LargeSpills:Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained HANDLING AND STORAGEG eneral Handling:Minimize dust generation and accumulation.

6 If tablets or capsules are crushed and/or broken,avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, useappropriate personal protective equipment (see Section 8). Wash thoroughly after and implement appropriate technical and procedural waste water and waste disposalmeasures to prevent occupational exposure or environmental releases. Potential points ofprocess emissions of this MATERIAL to the atmosphere should be controlled with dust collectors,HEPA filtration systems or other equivalent controls. Refer to Section 12 - EcologicalInformation, for information on potential effects on the Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure OEL - TWAL isted10 mg/m3 TWAOSHA - Final PELS - TWAs:15 mg/m3 total5 mg/m3 Page 3 of 8 Portugal OEL - TWAL istedAustralia TWA10 mg/m3 Romania OEL - TWAL istedSpain OEL - TWAL istedSilicon dioxide, colloidal NFBelgium OEL - TWAL istedAustralia TWA2 mg/m3 Revision date: 16-Jun-2011 MATERIAL Name.

7 Clopidogrel TabletsAustria OEL - MAKsListedEstonia OEL - TWAC zech Republic OEL - TWAL istedListedEstonia OEL - TWAL istedMicrocrystalline celluloseGermany - TRGS 900 - TWAs4 mg/m3 France OEL - TWAL istedGermany (DFG) - MAK4 mg/m3 MAKV ersion: OEL - TWAsListedACGIH Threshold Limit Value (TWA) MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONE ngineering Controls:Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this Exposure Controls:Refer to specific Member State legislation for requirements under Community Protective Equipment:Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).

8 Hands:Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing :Wear SAFETY glasses or goggles if eye contact is :Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing protection:If airborne exposures are within or exceed the Occupational Exposure Band (OEB) range, wearan appropriate respirator with a protection factor sufficient to control exposures to the bottom ofthe OEB PHYSICAL AND CHEMICAL PROPERTIES10. STABILITY AND REACTIVITYC hemical Stability:Stable under normal conditions of to Avoid:Fine particles (such as dust and mists) may fuel Materials:As a precautionary measure, keep away from strong oxidizers11. TOXICOLOGICAL INFORMATIONG eneral Information:The information included in this section describes the potential hazards of the Toxicity: (Species, Route, End Point, Dose)_____PZ01528 Ireland OEL - TWAsPfizer Occupational ExposureBand (OEB):OEB 3 (control exposure to the range of >10ug/m3 to < 100ug/m3)ListedLatvia OEL - TWAL istedPhysical State:Film-coated tabletsRevision date: 16-Jun-2011 Color:PinkMolecular Formula:MixtureOSHA - Final PELs - Table Z-3 Mineral D:- (80)/(% SiO2) mg/m3 TWATWA-20 mppcfClopidogrel bisulfateMolecular Weight:MixtureRat Oral LD50 2423 mg/kgMaterial Name: Clopidogrel TabletsMouse Oral LD50 2491 mg/kgSlovenia OEL - TWAL istedVersion.

9 4 of 8 Clopidogrel bisulfate MATERIAL SAFETY data SHEET_____11. TOXICOLOGICAL INFORMATIONA cute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the / Sensitization: (Study Type, Species, Severity)Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))Genetic Toxicity: (Study Type, Cell Type/Organism, Result)_____PZ015283 Month(s) Rat Oral 400 mg/kg/day NOAEL No effects at maximum doseRat Oral LD50 > 5000 mg/kg3 Month(s) Mouse Oral 400 mg/kg/day LOAEL LiverMouse Oral LD 50 22 g/kg1 Year(s) Rat Oral 35 mg/kg/day NOAEL LiverRabbit Dermal LD50 > 2000 mg/kgMaterial Name: Clopidogrel Tablets1 Year(s) Monkey Oral 65 mg/kg/day NOAEL Gastrointestinal system, LiverButylated hydroxyanisoleButylated hydroxyanisoleVersion.

10 Day(s) Rat Oral 3300 mg/kg LOAEL Liver, BloodPage 5 of 8 Clopidogrel bisulfateClopidogrel bisulfateRat Oral LD50 2000 mg/kgFertility and Embryonic Development Rat Oral 100 mg/kg/day NOAEL No effects at maximum doseEye Irritation Rabbit SevereEmbryo / Fetal Development Rat Oral 120 mg/kg/day NOAEL No effects at maximum doseMannitolEmbryo / Fetal Development Rabbit Oral 100 mg/kg/day NOAEL Maternal ToxicitySkin Irritation Rabbit CorrosivePeri-/Postnatal Development Rat Oral 25 mg/kg/day NOAEL Maternal ToxicityMouse Oral LD 50 1100 mg/kgButylated hydroxyanisoleMicrocrystalline celluloseEmbryo / Fetal Development Rat Oral 30 g/kg LOEL