MS; PES Piramal Critical Care Isoflurane, USP 1) PRODUCT AND COMPANY IDENTIFICATION Product name: Isoflurane, USP Synonyms! Terell Atane Tsolurane Escain Isofane Isofluran r [eoflurana 4-CHLORO-2.2,2-TRIFLUOROETHYL DIFLUOROMETHYL ETHER CAS Number: 26675-46-7 Formul CHF,OCCIHCFs (Chemical Family: Anesthetic, Halogenated Ether Manufacture Piramal Critical Care 3950 Schelden Circle Bethlehem, PA 18017 24 Hour Emergency Number: (CHEMTREC 1-703-527-3887 2) COMPOSITION/IINFORMATION ON INGREDIENTS Component Weight Classification Tsoflurane 100 "None 3) HAZARDS IDENTIFICATION Emergency Overview: CAUTION! Anesthetic Agent. Overexposure by inhalation tothe vapors may ‘cause temporary nervous system depression with anesthetic effects such as dizziness, headache, confusoa, coordination, or loss of conciousoess, they should be moved o an area of fresh ar. Concentrations of anesthetic inte air ‘would have to reach approximately 2-3 Ye before personnel would be expected {wexperience significant dizziness, Gross overexposure (> 20%) may possibly alter the hearts electrical ativity wth iregular pulse, palptationsor inadequate @ circulation Exposure Routes: Inhalation. Skin contact. Fye contact. Ingestion, Inhalation: Practically non-toxic by inkalation, Cardiovascular effects may include ‘yetuaions in heat rte, changes in blood preste, chest pin. Respiratory effects may include shoriness of breath, bronchospasm, aryngospsms, respiratory depression, Gastrointestinal effects may include pause, upset stomach, los of appetite. Nervous system eflecs may include ataxia, tremor, disturbance of speech, lethargy, headaches, dizziness, blued vision, Skin Contact: May cause skin invitation, Eye Contact: May cause eye irritation Ingestion: Practically non-tosie if swallowed, No spesific hazards other than therapeutic fects. See inhalation, D FIRST AID MEASURES Pree otInhalation: thigh concentrations ae inhaled, immediately remove to fresh ai. IFnot breathing, perform artificial respiration. Keop the affected person warm and atest, Get medical attention as soon as possible ‘Skin Contact: Incase of contet, remove contaminated clothing, and wash contaminated skin with sogp and water. Seck medical atenion if initation is present. Eye Cont Incase of contact, immediately wash (tigate) the eyes with large amounts of tepid potable water, occasionally iting the lower and upper lis. Get medical atcntion immediately. Ingestion: DO NOT induce vomiting unless directed to do so by medical personne [Never give anything by mouth 1 an unconscious person. If large quantities are swallowed, get medical attention immediately. Note to Physician: Due othe possible disturbances of cardiac shythm, catecholamine drugs, such as epinephrine, should be considered only a last reson in life- threatening emergencies. @ 5 FIREFIGHTING MEASURES Flash Point: [Not determined Specific Methods: 'No information available Flammable Limits in air-lower (%): Not available Flammable Limits ln alt-upper (7): ‘Autoignition: Extinguishing Medi Use extinguishing media appropriate wo surrounding fire conditions Fire Fighting Instructions: Fire fighters and others should wear NIOSH approved positive pressure sel contained breathing apparatus (SCBA) and turnout gear. Fire and Explosion Hazard: Use water spray to cool containers. Containers may rupture under fire conditions 9) ACCIDENTAL RELEASE MEASURES In Case of Spill or Leal ‘Small volumes of liquid anesthetic agents may readily evaporate at room temperatures and aay dissipate before any clean up attempts ae initiated. Fer large spills, provide adequate ventilation or evacuate area. Large quantities of anesthetic agents may cause sedative effects. Restit personnel not donning protective equipment from areas of spills or leaks until clear up is complete. A sorbent designed for organic chemicals shouldbe use for large spills. Spill pillows, vermiculite, ad earbon-based sorbents are examples of Suitable materials. Dike spill and prevent liquid from entering sewers, watervays or low areas. Sweep of Scoop up and remove toa suitable container. Close container and dispose of container in accordance with e {Sista lee elton 7) HANDLING AND STORAGE Mandi Wash thorough ater hing Sura: Kec conan th sealed Soe in ay col, and wll veiled place Store berween 15~ 30°C (39 - 86°F) 8) EXPOSURE CONTROLS/PERSONAL PROTECTION Engineering Controls: Investigate engineering techniques, process enclosures or local exhaust ventlation to keep airborne levels below recommended exposure limit Bye Protection: Safety glasses, chemical splash goggles, face shield, or other fll faced protetion should be available for use if potential exist for exposure 0 splashes, ‘Skin Protect (Chemical resistant, impervious gloves should be use to avoid prolonged or ee decRespiratory Protect ‘OSHA-Time Weighted Average: ‘OSHA-Short Term Exposure Limit: (OSHA-Ceiling Limits: ACGII-Time Weighted Average: ACGHEShort Term Exposure Limit: ‘ACGIH-Ceiting Limit Value: NIOSH REL! repeated exposure, Wear a work uniform or laboratory coat. Additional body fgrments should be used based upon the tasks being performed. ‘When working with small quantities in a well ventilated area, respiratory protection may not be required. Ir exposure levels exceed regulatory limit, Implement a respiratory protection program that isin compliance with OSHA. 29 CFRI910.134 or equivalent in eter rgions. Firefighting requires the use ‘ofa self-contained breathing apparatus with full face piese and postive pressure mode. None None None None None None Ceiling 2 ppm (60 minutes) recommended exposure limit for halogenated ‘waste anesthetic gas, QO SNSICATAND GHEMICAT PROPERTIES Physical State: D ‘Molecular Weight: Boiting Point: ‘Vapor Pressure: Evaporation Rate: Liguid Clear Coleress Slight ethereat Neutral 184.5 pimole 485°C (119.3) at 760 mm He 330mm Hg at 25°C (777) Not available Slightly soluble 100 WI Hazardous Decomposition Products: Material is stable under recommended storage conditions Peroxides Not applicable ‘These products are halogenated compounds (.., hydrochlori and hydroffourc aids, phosgene) Ti) TOXICOLOGICAL INFORMATION e LDw Ley, LD LD Les, LDy Acute Toxicity: Carcinogenic Effects: 4770 mg/Kg orak-ra 16300 ppm 3H inhalation-at 4280 gikg intrapertoneal-xat 5080 g/kg oral mouse 16800 ppay/3H inhaation-mouse 3030 mg/Kg intraperitoneal-mouse Cardiovascular effects - may include Muctuaton in heat rate, change ia blood pressure, chest pain, Respiratory effeets- may include shortness of breath, bronchospasm, laryngospacms, respiratory depression Gastrointestinal effects - may include nausea, upset stomach, loss of appa Nervous System effects - ataxia, tremor, dstubance of speech, lethargy, hneadache, dizziness, blued vision, ‘Target Organs- nervous system, heat, liver Not classified or listed by OSHA, IARC, NTP, EU, and! ACGIH. No drug related carcinogenicftumorigenic effects based on animal data.Motagenie Estects: [Not available Reproductive Toxicity: [No impairment to ferlty based on animal data. May be fetotoxieat high «ses based on animal data Epidemiological studies suggest higher than noma incidences of problem pregnancies (particularly spontaneous abortions) among expased personnel FDA Pregnaney Category: c 12) ECOLOGICAL INFORMATIO® Beotoricity Effect No data available Bioaccumulation: [No data available 13) DISPOSAL CONSIDERATIONS Waste Disposal ‘Comply with federal state, and local regulations in the disposal of waste, Ta) TRANSPORT INFORMATION bor: [Not regulated for inner packagings not exceeding 5.0L. (13 gallons) net ‘capacity each, Regulated for inner packagings exceeding $.0 (13 gallons) net capacity cach DOT shipping name: Aviation regulated ligud, N.O.S, (lsflurane) UN mumber: UN3334 Packing Group: None DOT hazard class: 9 ICAOMATA: IATA proper shipping name: Aviation regulated iguid, N.OS, (Isoflurane) IATA UN number: UN3334 IATA primary hazard class: 9 TATA packing group: None IATA packing instruction: ‘TDG (Canada): Not regulated Not regulated Not regulated 06 15) REGULATORY INFORMATION Regulated This produet is excerpt from TSCA, 16) OTHER INFORMATION New MSDS format. ‘The information abows i believed to be accurate and i intended only a a guide. Piramal Critical Care assumes no responsibilty for any damages resulting from handling or contact with the above material.