MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Lipitor ( atorvastatin Calcium) TabletsTrade Name:Lipitor Chemical Family:MixtureIntended Use:Pharmaceutical product used as Lipid regulating HAZARDS IDENTIFICATIONA ppearance:White film-coated tabletsStatement of Hazard:Non-hazardous in accordance with international standards for workplace Hazard Information:Short Term:May cause eye irritation (based on components) .Long Term:Repeat-dose studies in animals have shown a potential to cause adverse effects on Clinical Effects:Adverse effects associated with therapeutic use of atorvastatin include constipation,flatulence, upset stomach, and abdominal pain. Clinical use of this drug has caused changesin liver function, muscle pain, Indication of danger:Not classifiedAustralian Hazard Classification(NOHSC):Non-Hazardous Substance.

2 Non-Dangerous :This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warnings included may not apply in all needs may vary depending upon the potential for exposure in your COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS List EU Classification% atorvastatin calcium134523-03-8 Not ListedR52 carbonate471-34-1207-439-9 Not Listed*Microcrystalline cellulose9004-34-6232-674-9 Not Listed*Magnesium stearate557-04-0209-150-3 Not Listed*_____PD009 Revision date: 06-Feb-2013 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 Contact MATERIAL SAFETY DATA SHEETPage 1 of 8 Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222 Pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Emergency telephone number:CHEMTREC (24 hours).

3 1-800-424-9300 MATERIAL SAFETY DATA SHEET_____IngredientCAS NumberEU EINECS/ELINCS List EU Classification%Simethicone emulsion67762-90-7 Not ListedNot Listed*Lactose NF, monohydrate64044-51-5 Not ListedNot Listed*Croscarmellose sodium74811-65-7 Not ListedNot Listed*Hydroxypropyl cellulose9004-64-2 Not ListedNot Listed*Opadry whiteNOT ASSIGNEDNot ListedNot Listed*Polysorbate 809005-65-6 Not ListedNot 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:Immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, getmedical Contact:Remove contaminated clothing and shoes. Wash skin with soap and water. If irritation occursor persists, get medical :Get medical attention.

4 Do not induce vomiting unless directed by medical personnel. Nevergive anything by mouth to an unconscious :Remove to fresh air. If not breathing, give artificial respiration. Get medical 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 / Explosion Hazards:Fine particles (such as dust and mists) may fuel ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions:Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8).

5 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 2 of 8 Revision date: 06-Feb-2013 MATERIAL Name: Lipitor ( atorvastatin Calcium) TabletsVersion: MATERIAL SAFETY DATA SHEET_____7. HANDLING AND STORAGEG eneral 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.

6 When handling, useappropriate personal protective equipment (see Section 8). Wash hands and any exposed skinafter removal of PPE. Releases to the environment should be avoided. Review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure or environmental releases. Potential points of process emissions of thismaterial to the atmosphere should be controlled with dust collectors, HEPA filtration systems orother equivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure Method:Analytical method available for atorvastatin . Contact Pfizer Inc for further 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.

7 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)._____PD00910 mg/m3 Version: OEL - TWA10 mg/m3 France OEL - TWA10 mg/m3 Bulgaria OEL - mg/m3 Ireland OEL - TWAs10 mg/m34 mg/m3 atorvastatin calciumLatvia OEL - TWA2 mg/m3 France OEL - TWAOSHA - Final PELS - TWAs:15 mg/m310 mg/m3 Page 3 of 8 Portugal OEL - TWA10 mg/m3 Spain OEL - TWA10 mg/m3 Latvia OEL - TWA6 mg/m3 Magnesium stearateACGIH Threshold Limit Value (TWA)10 mg/m3 Pfizer OEL TWA-8 Hr:Lithuania OEL - TWA5 mg/m3 Poland OEL - TWA10 mg/m3 Sweden OEL - TWAs5 mg/m350 g/m3 Portugal OEL - TWA10 mg/m3 Revision date: 06-Feb-2013 Microcrystalline celluloseCalcium carbonateACGIH Threshold Limit Value (TWA)10 mg/m3 MATERIAL Name: Lipitor ( atorvastatin Calcium) TabletsAustralia TWA10 mg/m3 Australia TWA10 mg/m3 Belgium OEL - TWA MATERIAL SAFETY DATA SHEET_____8.

8 EXPOSURE CONTROLS / PERSONAL PROTECTIONH ands: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 the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the PHYSICAL AND CHEMICAL PROPERTIESP olymerization:Will not occur10. 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)Acute 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)_____PD009 Color:WhiteMagnesium stearateMaterial Name: Lipitor ( atorvastatin Calcium) TabletsRat Oral LD50 > 2000 mg/kgMolecular Formula:MixtureRat Inhalation LC50 > 2000 mg/m3 Version: 80 Molecular Weight.

9 MixtureRat Oral LD50 25 g/kgMicrocrystalline celluloseAtorvastatin calciumPage 4 of 8 Rat/Mouse Oral LD50 > 5000 mg/kgRat Oral LD50 > 5000 mg/kgRabbit Dermal LD50 > 2000 mg/kgRabbit Dermal LD50 > 2000 mg/kgPhysical State:TabletCalcium carbonateRevision date: 06-Feb-2013 Rat Oral LD50 6450 mg/kg MATERIAL SAFETY DATA SHEET_____11. TOXICOLOGICAL INFORMATIONR epeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))Genetic Toxicity: (Study Type, Cell Type/Organism, Result)MutagenicityNo evidence of mutagenic or clastogenic activity in in vitro or in vivo : (Duration, Species, Route, Dose, End Point, Effect(s))Carcinogen Status:None of the components of this formulation are listed as a carcinogen by IARC, NTP or ECOLOGICAL INFORMATIONE nvironmental Overview:In the environment, the active ingredient in this formulation is expected to remain in water ormigrate through the soil.

10 Not readily biodegradable. May have harmful effects on the aquaticenvironment. May persist in the aquatic environment. Releases to the environment should , Persistence andDegradability:<10% biodegraded in 28 days ( atorvastatin calcium)Aquatic Toxicity: (Species, Method, End Point, Duration, Result)_____PD009 atorvastatin calciumEye Irritation Rabbit Non-irritatingAtorvastatin calcium104 Week(s) Dog Oral 10 mg/kg/day LOAEL LiverIn Vitro Bacterial Mutagenicity (Ames) Salmonella , E. coli NegativeMaterial Name: Lipitor ( atorvastatin Calcium) TabletsIn Vivo Micronucleus Mouse Bone Marrow Negative13 Week(s) Mouse Oral 100 mg/kg/day LOAEL LiverAtorvastatin calcium52 Week(s) Rat Oral 5 mg/kg/day NOAEL LiverVersion: calciumPage 5 of 8104 Week(s) Mouse Oral 200 mg/kg/day NOAEL Not carcinogenic13 Week(s) Rat Oral 5 (male).