MATERIAL SAFETY DATA SHEET - pfizer.com

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Methotrexate TabletsTrade Name:METHOBLASTIN; MAXTREX; LEDERTREXATE; NOVATREX; LANTARELC hemical Family:Not determinedIntended Use:Antineoplastic2. HAZARDS IDENTIFICATIONA ppearance:Pale Yellow TabletsSignal Word:WARNINGS tatement of Hazard:Harmful if damage the unborn of causing genetic Hazard Information:Long Term:Repeat-dose studies in animals have shown a potential to cause adverse effects on bloodforming organs and the developing Clinical Effects:Adverse effects associated with therapeutic use include gastrointestinal disturbances such asnausea, dyspepsia, and vomiting and gastrointestinal irritation. Effects on blood and blood-forming organs have also occurred.

2 Birth defects have occurred in infants of women taking thisdrugEU Indication of danger:HarmfulToxic to reproduction: Category 1 Mutagenic: Category 3EU Risk Phrases:R22 - Harmful if - May cause harm to the unborn - Possible risk of irreversible Hazard Classification(NOHSC):Hazardous Substance. Non-Dangerous 1 of 9 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): 1-800-424-9300 Revision date: 13-Mar-2012 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 Contact MATERIAL SAFETY data SHEET MATERIAL SAFETY data SHEET_____2.

3 HAZARDS IDENTIFICATIONA dditional Information:For a more detailed discussion of potential health hazards and toxicity see Section :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%Methotrexate59-05-2200-41 3-8 Mut. ;R68 Repr. ;R61T; - 10 Magnesium stearate557-04-0209-150-3 Not Listed*Maize starch9005-25-8232-679-6 Not Listed*Microcrystalline cellulose9004-34-6232-674-9 Not Listed*Starch, pregelatinized9005-25-8232-679-6 Not Listed*IngredientCAS NumberEU EINECS/ELINCS List EU Classification%Purified water7732-18-5231-791-2 Not Listed*Lactose63-42-3200-559-2 Not 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.

4 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 :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 : 2 of 9 Revision date: 13-Mar-2012 MATERIAL Name: Methotrexate Tablets MATERIAL SAFETY data SHEET_____Fire Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing / Explosion Hazards.

5 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). 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:If tablets or capsules are crushed and/or broken, avoid breathing dust and avoid contact witheyes, skin, and clothing. Minimize dust generation and accumulation. When handling, useappropriate personal protective equipment (see Section 8). Wash thoroughly after to the environment should be avoided. Review and implement appropriate technicaland procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this MATERIAL to theatmosphere should be controlled with dust collectors, HEPA filtration systems or otherequivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure mg/m3 Maize starchPfizer OEL TWA-8 Hr:ACGIH Threshold Limit Value (TWA)10 mg/m32 g/m3 Australia TWA10 mg/m3 Revision date: 13-Mar-2012 Belgium OEL - TWA10 mg/m3 Magnesium stearateMaterial Name: Methotrexate TabletsBulgaria OEL - mg/m3 Czech Republic OEL - mg/m3 ACGIH Threshold Limit Value (TWA)10 mg/m3 Greece OEL - TWA10 mg/m35 mg/m3 Version.

7 OEL - TWAs10 mg/m34 mg/m3 Page 3 of 9 Lithuania OEL - TWA5 mg/m3 MethotrexateSweden OEL - TWAs MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONA nalytical Method:Analytical method available for Methotrexate. 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. 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 the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the , pregelatinizedOSHA - Final PELS - TWAs:ACGIH Threshold Limit Value (TWA)10 mg/m3 ACGIH Threshold Limit Value (TWA)10 mg/m3 Australia TWA10 mg/m315 mg/m3 Belgium OEL - TWA10 mg/m3 Bulgaria OEL - mg/m3 Australia TWA10 mg/m3 Czech Republic OEL - mg/m3 Greece OEL - TWA10 mg/m35 mg/m3 Belgium OEL - TWAI reland OEL - TWAs10 mg/m34 mg/m310 mg/m3 OSHA - Final PELS - TWAs:15 mg/m3 Portugal OEL - TWA10 mg/m3 Portugal OEL - TWA10 mg/m3 Estonia OEL - TWA10 mg/m3 Slovakia OEL - TWA4 mg/m3 Spain OEL - TWA10 mg/m3 Revision date: 13-Mar-2012 France OEL - TWA10 mg/m3 Ireland OEL - TWAs10 mg/m34 mg/m3 Slovakia OEL - TWA4 mg/m3 Latvia OEL - TWA2 mg/m3 MATERIAL Name: Methotrexate TabletsOSHA - Final PELS - TWAs.

9 15 mg/m3 Spain OEL - TWAP ortugal OEL - TWA10 mg/m310 mg/m3 Version: OEL - TWA10 mg/m3 Page 4 of 9 Spain OEL - TWA10 mg/m3 Microcrystalline cellulose MATERIAL SAFETY data SHEET_____9. 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:There are no data for this formulation. The information included in this section describes thepotential hazards 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)_____PZ00130 Rat Inhalation LC50 > 2000 mg/m3 MixtureMicrocrystalline celluloseVersion: Oral LD50 > 5000 mg/kgMolecular Weight.

10 Rabbit Dermal LD50 > 2000 mg/kgMixtureRat Oral LD50 135 mg/kgPolysorbate 80 Rat Oral LD50 25 g/kgPage 5 of 9 Rat Sub-tenon injection (eye) LD50 6 mg/kgLactoseRat Oral LD50 > 10 g/kgRat Intravenous LD50 14 mg/kgPhysical State:Mouse Oral LD50 146 mg/kgMicrocrystalline celluloseTabletsRevision date: 13-Mar-2012 Skin Irritation Rabbit Non-irritatingNot Specified Inhalation LC50 > 188 ug/m3 Eye Irritation Rabbit Non-irritatingColor:Magnesium stearatePale yellowMaterial Name: Methotrexate TabletsRat Oral LD50 > 2000 mg/kgMolecular Formula: MATERIAL SAFETY data SHEET_____11.