MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial name : anastrozole TabletsTrade name :Not applicableChemical Family:Aromatase inhibitorIntended Use:Pharmaceutical product used as Antineoplastic2. HAZARDS IDENTIFICATIONA ppearance:White TabletsSignal Word:DANGERS tatement of Hazard:May damage fertility or the unborn Hazard Information:Long Term:Animal studies have shown a potential to cause adverse effects on the fetus. Repeat-dosestudies in animals have shown a potential to cause adverse effects on reproductive Clinical Effects:Adverse effects associated with therapeutic use include hot flashes, inflammation of the liver,abnormal liver function tests, skin reaction, swelling of the face, loss of hair, joint pain,gastrointestinal disturbances, headacheEU ClassificationEU Indication of danger:Toxic to reproduction, Category 2EU Hazard Symbols:EU Risk Phrases:R60 - May impair - May cause harm to the unborn Hazard Classification(NOHSC):Hazardous Substance.

2 Non-Hazardous 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 7 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.

3 Your needs may vary depending upon the potential for exposure in COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS List EU Classification%Anastrozole120511-73-1 Not ;R60-611 Magnesium stearate557-04-0209-150-3 Not Listed*IngredientCAS NumberEU EINECS/ELINCS List EU Classification%Sodium starch glycolate9063-38-1 Not ListedNot Listed*Lactose NF, monohydrate64044-51-5 Not ListedNot Listed*Povidone9003-39-8 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: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 / Explosion Hazards:Not applicable_____PZ01527 MATERIAL name : anastrozole TabletsVersion: 2 of 7 Revision date: 16-Jun-2011 MATERIAL SAFETY data SHEET_____6.

5 ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions: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.

6 Clean up operations should only be undertaken by trained HANDLING AND STORAGEG eneral Handling:Restrict access to work area. Minimize dust generation and accumulation. If tablets orcapsules 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. Refer to Section 12 - Ecological Information, for information onpotential effects on the environment. Releases to the environment should be avoided. Reviewand implement appropriate technical and procedural waste water and waste disposal measuresto prevent occupational exposure or environmental releases.

7 Potential points of processemissions of this MATERIAL to the atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure 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, disposable gloves (double suggested) are recommended if skin contact with drugproduct is possible and for bulk processing OEL - TWAL isted10 mg/m3 TWAR evision date: 16-Jun-2011 Sweden OEL - TWAsListedMaterial name : anastrozole TabletsAnastrozoleAustralia TWA10 mg/m3 Pfizer Occupational ExposureBand (OEB):OEB 5 (control exposure to <1ug/m3)Version: OEL - TWAL istedPage 3 of 7 Ireland OEL - TWAsListedMagnesium stearateLithuania OEL - TWAL istedPortugal OEL - TWAL istedACGIH Threshold Limit Value (TWA) MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONEyes:Wear SAFETY glasses or goggles if eye contact is :Impervious disposable protective clothing is recommended if skin contact with drug product ispossible and for 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.

9 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:There are no data for this formulation. The remaining information describes the potentialhazards of the individual 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)Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))_____PZ01527 AnastrozoleColor:Rat Oral LD50 > 100 mg/kgWhiteRat IP LD50 > 50 mg/kgMolecular Formula.

10 Dog Oral LD50 > 45 mg/kgMixtureRevision date: 16-Jun-2011 PovidoneMolecular Weight:MixtureRat Oral LD50 100 g/kgAnastrozoleMaterial name : anastrozole Tablets6 Month(s) Rat No route specified 1 mg/kg/day LOAEL Female reproductive systemMagnesium stearateVersion: Oral LD50 > 2000 mg/kgPhysical State:Rat Inhalation LC50 > 2000 mg/m3 TabletsPage 4 of 7 MATERIAL SAFETY data SHEET_____11. TOXICOLOGICAL INFORMATIONG enetic Toxicity: (Study Type, Cell Type/Organism, Result)Carcinogenicity: (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:Environmental properties have not been investigated.