MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Methotrexate Solution for InjectionTrade Name:Methoblastin; Maxtrex; Methotrexat; Lantarel; TrexanChemical Family:MixtureIntended Use:Antineoplastic2. HAZARDS IDENTIFICATIONA ppearance:Clear yellow solutionStatement of Hazard:Non-hazardous in accordance with international standards for workplace Hazard Information:Short Term:May be absorbed through the skin and cause systemic effects. May be harmful if swallowed.(based on components) .Long Term:Animal studies have shown a potential to cause adverse effects on the fetus.

2 The use of thisdrug during pregnancy has resulted in birth 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 Indication of danger:Not classifiedNote: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 azardous_____PZ00135 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 29-Mar-2012 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 Pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 MATERIAL SAFETY data SHEET_____3. COMPOSITION/INFORMATION ON INGREDIENTSI ngredientCAS NumberEU EINECS/ELINCS List EU Classification%Methotrexate59-05-2200-41 3-8 Mut.

4 ;R68 Repr. ;R61T; hydroxide1310-73-2215-185-5C;R35###Ingre dientCAS NumberEU EINECS/ELINCS List EU Classification%Sodium chloride7647-14-5231-598-3 Not Listed*Water for Injection7732-18-5231-791-2 Not Listed*Additional Information:* Proprietary### as (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. Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water.

5 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.

6 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 spill with absorbent MATERIAL . Clean spillarea : 2 of 7 Revision date: 29-Mar-2012 MATERIAL Name: Methotrexate Solution for Injection MATERIAL SAFETY data SHEET_____Measures for EnvironmentalProtections:Place waste in an appropriately labeled, sealed container for disposal.

7 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:Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist. Wash thoroughlyafter handling. Avoid open 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.

8 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).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 OEL - TWA2 mg/m3 Hungary OEL - TWA2 mg/m3 Lithuania OEL - TWA5 mg/m3 Japan - OELs - Ceilings2 mg/m3 MethotrexateLatvia OEL - mg/m3 Sodium hydroxideOSHA - Final PELS - TWAs:2 mg/m3 Version: 3 of 7 Poland OEL - mg/m3 ACGIH Ceiling Threshold Limit.

9 Slovakia OEL - TWA2 mg/m32 mg/m3 Slovenia OEL - TWA2 mg/m3 Pfizer OEL TWA-8 Hr:Sweden OEL - TWAs1 mg/m3 Australia PEAK2 mg/m32 g/m3 Austria OEL - MAKs2 mg/m3 Bulgaria OEL - mg/m3 Sodium chlorideCzech Republic OEL - TWA1 mg/m3 Revision date: 29-Mar-2012 Estonia OEL - TWA1 mg/m3 Latvia OEL - TWA5 mg/m3 France OEL - TWA2 mg/m3 MATERIAL Name: Methotrexate Solution for Injection MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONR espiratory 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 PROPERTIES10.

10 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)Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)_____PZ00135 Rat Oral LD50 3000 mg/kgRevision date: 29-Mar-2012 Molecular Formula.