MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: chlorhexidine Aqueous Irrigations w/vTrade Name:Not establishedChemical Family:MixtureIntended Use:Pharmaceutical product used as disinfectant, antiseptic2. HAZARDS IDENTIFICATIONA ppearance:Clear blue liquidStatement of Hazard:Non-hazardous in accordance with international standards for workplace Hazard Information:Short Term:May cause eye irritation (based on components) .EU Indication of danger:Not classifiedAustralian Hazard Classification(NOHSC):Non-Hazardous Substance. Non-Dangerous :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.

2 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%Methylene Blue61-73-4200-515-2Xn; Gluconate18472-51-0242-354-0Xn;R220-1 IngredientCAS NumberEU EINECS/ELINCS List EU Classification%_____PZ00713 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: 27-Jun-2012 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 Contact MATERIAL SAFETY data SHEETPage 1 of 6 MATERIAL SAFETY data SHEET_____Water for injection7732-18-5231-791-2 Not Listed*Nonoxynol-926027-38-3 Not ListedNot Information.

3 * 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 eyes with water for at least 15 minutes. If irritation occurs or persists, get Contact:Remove contaminated clothing and wash exposed area with soap and water. Obtain medicalassistance if irritation :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 FIRE FIGHTING MEASURESE xtinguishing Media:Use carbon dioxide, dry chemical, or water Combustion Products:Formation of toxic gases is possible during heating or fire.

4 May include oxides of carbon,nitrogen and products of Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing / Explosion Hazards:Not applicable6. 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 for EnvironmentalProtections:Place waste in an appropriately labeled, sealed container for disposal.

5 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 date: 27-Jun-2012 MATERIAL Name: chlorhexidine Aqueous Irrigations w/vVersion: 2 of 6 MATERIAL SAFETY data SHEET_____7. HANDLING AND STORAGEG eneral Handling:Avoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. 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.

6 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 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).

7 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 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 PROPERTIESW ater solubility:23 mg/L@37 CVapor Pressure (kPa) 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 oxidizers_____PZ00713 Physical State:LiquidColor:BlueVersion: Formula:MixtureMolecular Weight:MixturePfizer Occupational ExposureBand (OEB):OEB 4 (control exposure to the range of 1ug/m3 to <10ug/m3)Page 3 of 6 Revision date: 27-Jun-2012 MATERIAL Name: chlorhexidine Aqueous Irrigations w/vChlorhexidine Gluconate MATERIAL SAFETY data SHEET_____11.

8 TOXICOLOGICAL INFORMATIONG eneral Information:The information included in this section describes the potential hazards of the Toxicity: (Species, Route, End Point, Dose)Irritation / Sensitization: (Study Type, Species, Severity)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 ECOLOGICAL INFORMATIONE nvironmental Overview:The environmental characteristics of this mixture have not been fully evaluated. Releases tothe environment should be DISPOSAL CONSIDERATIONSW aste Treatment Methods:Dispose of waste in accordance with all applicable laws and regulations.

9 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 GluconateRat Oral LD50 2000 mg/kgIn Vivo Cytogenetics Hamster NegativeMaterial Name: chlorhexidine Aqueous Irrigations w/vIn Vivo Dominant Lethal Assay Mouse NegativeChlorhexidine GluconateRat Para-periosteal LD50 mg/kgEye Irritation Rabbit ModerateVersion.

10 4 of 6 Mouse Oral LD50 1260 mg/kgChlorhexidine GluconateEmbryo / Fetal Development Rat Oral 68 mg/kg/day NOAEL Not teratogenicMouse Intravenous LD50 mg/kgMethylene BlueChlorhexidine GluconateFertility and Embryonic Development Rat Oral 125 mg/kg/day NOAEL Developmental toxicityMethylene BlueFertility and Embryonic Development Rat Oral 50 mg/kg/day LOAEL Maternal ToxicityRevision date: 27-Jun-2012 Rat Oral LD50 1180 mg/kg MATERIAL SAFETY data SHEET_____14. TRANSPORT INFORMATIONThe following refers to all modes of transportation unless specified regulated for transport under USDOT, EUADR, IATA, or IMDG REGULATORY INFORMATIONEU Indication of danger:Not classifiedOSHA Label:Non-hazardous in accordance with international standards for workplace - WHMIS: ClassificationsWHMIS hazard class:None requiredThis product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the informationrequired by the BlueWater for injectionVersion: - United States TSCA - Sect.