MATERIAL SAFETY DATA SHEET - pfizer.com

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Docetaxel InjectionTrade Name:Not applicableChemical Family:Not determinedIntended Use:Antineoplastic2. HAZARDS IDENTIFICATIONA ppearance:Clear, colorless to pale yellow solutionSignal Word:DANGERS tatement of Hazard:Flammable liquid and of causing genetic damage fertility or the unborn cause harm to breastfed 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 centralnervous system, gastrointestinal system, blood and blood forming organs, and Clinical Effects:Common adverse effects include blood cell changes, nervous system/brain toxicity(neurotoxicity). Serious allergic reactions, including anaphylaxis, have been Indication of danger:Toxic to reproduction: Category 1 Mutagenic: Category 3 IrritantEU Hazard Symbols:EU Risk Phrases:R10 - - May cause harm to the unborn - Possible risk of irreversible - May cause harm to breastfed Hazard Classification(NOHSC):Hazardous Substance.

2 Dangerous LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 21-Mar-2012 Emergency telephone number:Poisons Information Centre: 13 1126 Contact MATERIAL SAFETY data SHEETPage 1 of 9 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%Ethyl alcohol (ethanol)64-17-5200-578-6F;R11<40 Citric acid, anhydrous77-92-9201-069-1 Not Listed**Propylene glycol57-55-6200-338-0 Not Listed*Docetaxel anhydrous114977-28-5 Not ; ;R68R64Xi;R361 IngredientCAS NumberEU EINECS/ELINCS List EU Classification%Polysorbate 809005-65-6 Not ListedNot Listed*Edetate disodium139-33-3205-358-3 Not Listed*Additional Information:* Proprietary** to adjust pHIngredient(s) indicated as hazardous have been assessed under standards for the full text of the R phrases mentioned in this Section, see Section 164.

3 FIRST AID MEASURESEye Contact:Flush with water while holding eyelids open for at least 15 minutes. Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical attention. For information on potential delayed effects, see Section 2 - HazardsIdentification and/or Section 11 - Toxicological :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 date: 21-Mar-2012 MATERIAL Name: Docetaxel InjectionVersion: 2 of 9 MATERIAL SAFETY data SHEET_____Hazardous 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).

4 Minimize for Cleaning / Collecting:Contain the source of spill if it is safe to do so. Collect spill with absorbent MATERIAL . Clean spillarea 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:Flammable liquid and vapor- keep away from ignition sources and clean up spills possible ignition sources ( , heat, sparks, flame, impact, friction, electricity), andfollow appropriate grounding and bonding procedures. Avoid contact with eyes, skin, andclothing. Use appropriate personal protective equipment. Wash thoroughly after breathing vapor or mist. Avoid contact with eyes, skin and clothing.

5 When handling, useappropriate personal protective equipment (see Section 8). Wash thoroughly after hands and any exposed skin after removal of PPE. Releases to the environment shouldbe avoided. Review and implement appropriate technical and procedural waste water andwaste disposal measures to prevent occupational exposure or environmental points of process emissions of this MATERIAL to the atmosphere should be controlledwith 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 OEL - MAKs1000 ppm1900 mg/m3 Revision date: 21-Mar-2012 Belgium OEL - TWA1000 ppm1907 mg/m3 Ethyl alcohol (ethanol)Bulgaria OEL - mg/m3 MATERIAL Name: Docetaxel InjectionCzech Republic OEL - TWA1000 mg/m3 ACGIH Threshold Limit Value (STEL)Denmark OEL - TWA1000 ppm1900 mg/m31000 ppmEstonia OEL - TWA500 ppm1000 mg/m3 Version: TWA1000 ppm1880 mg/m3 Page 3 of 9 MATERIAL SAFETY data SHEET_____8.

6 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)._____PZ009061900 mg/m3 MATERIAL Name: Docetaxel InjectionPortugal OEL - TWA1000 ppmGermany (DFG) - MAKR omania OEL - TWA1000 ppm1900 mg/m3500 ppm960 mg/m3 Version: OEL - TWA500 ppm960 mg/m3 Page 4 of 9 Slovenia OEL - TWA1000 ppm1900 mg/m3 Greece OEL - TWA1000 ppm1900 mg/m3 Spain OEL - TWA1000 ppm1910 mg/m3 Sweden OEL - TWAs500 ppm1000 mg/m3 Finland OEL - TWAP ropylene glycolHungary OEL - TWA1900 mg/m3 Australia TWA150 ppm474 mg/m310 mg/m31000 ppm1900 mg/m3 Ireland OEL - TWAs150 ppm470 mg/m310 mg/m3 Ireland OEL - TWAsLatvia OEL - TWA7 mg/m31000 ppm1900 mg/m3 Lithuania OEL - TWA7 mg/m3 Docetaxel anhydrousLatvia OEL - TWA1000 mg/m3 pfizer Occupational ExposureBand (OEB):OEB 4 (control exposure to the range of >1ug/m3 to <10ug/m3)France OEL - TWA1000 ppm1900 mg/m3 Lithuania OEL - TWA500 ppm1000 mg/m3 Revision date: 21-Mar-2012 Netherlands OEL - TWA260 mg/m3 OSHA - Final PELS - TWAs.

7 1000 ppm1900 mg/m3 Germany - TRGS 900 - TWAs500 ppm960 mg/m3 Poland OEL - TWA MATERIAL SAFETY data SHEET_____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 PROPERTIESpH:4-710. 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)_____PZ00906 Clear, colorless to paleyellowPolysorbate 80 MATERIAL Name: Docetaxel InjectionRat Intravenous LD 50 1790 mg/kgMolecular Formula:MixtureMouse Oral LD 50 25 g/kgVersion: glycolMolecular Weight:MixtureMouse Oral LD50 22,000 mg/kgDocetaxel anhydrousRat Oral LD50 20,000 mg/kgPage 5 of 9 Rabbit Dermal LD50 20,800 mg/kgRat Oral LD50 > 2000 mg/kgEthyl alcohol (ethanol)Mouse Oral LD50 3450 mg/kgMouse IV LD50 138 mg/kgRat Oral LD50 7060 mg/kgPhysical State:Rat Inhalation LC50 10h 20,000 ppmSolutionCitric acid, anhydrousRevision date: 21-Mar-2012 Rat Oral LD50 3000 mg/kgColor.

8 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)Carcinogen Status:None of the components of this formulation are listed as a carcinogen by IARC, NTP or Month(s) Rat Intravenous mg/kg/day NOEL Blood forming organs, Male reproductive systemEye Irritation Rabbit SeverePage 6 of 9 Docetaxel anhydrousSkin Irritation Rabbit MildReproductive & Fertility Rat Intravenous mg/kg/day LOAEL Paternal toxicityDocetaxel anhydrousEmbryo / Fetal Development Rat Intravenous mg/kg/day LOAEL Maternal Toxicity, Embryotoxicity, Fetotoxicity, NotTeratogenicPropylene glycolEmbryo / Fetal Development Rabbit Intravenous mg/kg/day LOAEL Embryotoxicity, Fetotoxicity, Maternal Toxicity,Not TeratogenicEdetate disodiumSkin Irritation Rabbit MildDocetaxel anhydrousEye Irritation Rabbit IrritantIn Vitro Bacterial Mutagenicity (Ames) Salmonella , E.

9 Coli NegativeEye Irritation Rabbit MildIn Vivo Micronucleus Mouse PositiveIn Vitro Chromosome Aberration Chinese Hamster Ovary (CHO) cells PositiveEthyl alcohol (ethanol)Skin Irritation Rabbit Non-irritatingEye Irritation Rabbit SevereRat Oral LD50 2000-2200 mg/kgEthyl alcohol (ethanol)Skin Irritation Rabbit MildIARC:Group 1 (Carcinogenic to Humans)Skin Sensitization NegativeOSHA:ListedRevision date: 21-Mar-2012 MATERIAL Name: Docetaxel InjectionDocetaxel anhydrousCitric acid, anhydrous28-31 Day(s) Rat Intravenous mg/m2/day NOEL Blood forming organs, Male reproductive systemVersion: MATERIAL SAFETY data SHEET_____12. ECOLOGICAL INFORMATIONE nvironmental Overview:Environmental properties have not been thoroughly investigated. Releases to the environmentshould be , Persistence andDegradability:Not readily biodegradable (0% in 28 days)Aquatic Toxicity: (Species, Method, End Point, Duration, Result)Aquatic Toxicity Comments:A greater than (>) symbol indicates that acute ecotoxicity was not observed at the maximumsolubility.

10 Since the substance is insoluble in aqueous solutions above this concentration, anacute ecotoxicity value ( LC/EC50) is not DISPOSAL CONSIDERATIONSW aste Treatment Methods:Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the MATERIAL , review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and TRANSPORT INFORMATIONThe following refers to all modes of transportation unless specified MATERIAL is regulated for transportation as a hazardous MATERIAL /dangerous number:UN 1170UN proper shipping name:Ethanol solutionTransport hazard class(es):3 Packing group:IIIF lash Point ( C):24 Flash Point ( C):2415.