GLAXO INC -- VENTOLIN (ALBUTEROL SULATE) INHALATION SOLUTI ======================================================= MSDS Safety Information ======================================================= FSC: 6505 NIIN: 01-257-9953 MSDS Date: 03/17/1997 MSDS Num: CJQMF Product ID: VENTOLIN (ALBUTEROL SULATE) INHALATION SOLUTION, 0.5% MFN: 02 Responsible Party Cage: 34006 Name: GLAXO INC Address: 5 MOORE DR City: RESEARCH TRIANGLE PARK NC 27709 Info Phone Number: 919-248-2354 Emergency Phone Number: 919-248-2100/2700 ======================================================= Item Description Information ======================================================= Item Manager: S9M Item Name: ALBUTEROL SULFATE INHALATION SOLUTION Unit of Issue: BT Quantitative Expression: 00000000020ML ======================================================= Ingredients ======================================================= Cas: 18559-94-9 RTECS #: 1008001AL Name: ALBUTEROL % Wt: 5.0 Other REC Limits: 0.01 MG/M3 OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ======================================================= Health Hazards Data ======================================================= LD50 LC50 Mixture: LD50 (ORAL RAT) IS UNKNOWN Route Of Entry Inds - Inhalation: YES Skin: YES Ingestion: YES Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: EYES & RESPIRATORY TRACT IRRITATION. ALBUTEROL IS A B2-ADRENEGIC BRONCHODILATOR AND MAY CAUSE MUSCULAR TREMOR, MUSCLE CRAMPS, NAUSEA AND VOMITING, HEADACHE, NERVOUSNESS, DIZZINESS, HEARTBURN AND RAPID PULSE, ELEVATED BLOOD PRESSURE AND EXAC ERBATION OF CARDIOVASCULAR DISEASES AND DIABETES. HYPERSENSITIVITY REACTIONS, SUCH AS HIVES, SKIN RASH, CONSTRICTION OF AIR PASSAGES IN LUNGS, SWELLING OF SKIN AND MUCUS MEMBRANES HAVE BEEN REPORTED. Explanation Of Carcinogenicity: NONE OF THE COMPOUNDS IN THIS PRODUCT IS LISTED BY IARC, NTP, OR OSHA AS A CARCINOGEN. Signs And Symptions Of Overexposure: EYE, SKIN & RESPIRATORY TRACT IRRITATION, HEADACHE, NAUSEA,DIZZINESS, VOMITING, NERVOUSNESS, RAPID PULSE, INCREASED BLOOD PRESSURE, HIVES, SKIN RASH, DIFFICULTY IN BREATHING. Medical Cond Aggravated By Exposure: CARDIOVASCULAR AND DIABETES. First Aid: INHALATION:REMOVE TO FRESH AIR. RESUSCITATE IF NOT BREATHING. GET MEDICAL ATTENTION. EYES:IMMEDIATELY FLUSH WITH PLENTY OF WATER FOR 15 MINUTES HOLDING EYELIDS OPEN. GET MEDICAL ATTENTION. SKIN:REMOVE CONTAMINATED CLOTHING. WASH WITH SOAP A ND WATER. IF IRRITATION PERSISTS, GET MEDICAL ADVICE. INGESTION: RINSE MOUTH WITH WATER IF CONSCIOUS. GET IMMEDIATE MEDICAL ATTENTION. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: RECOVER BY VACUUMING. OR COLLECT SPILL AND TRANSFER TO A CLOSED WASTE CONTANER FOR DISPOSAL. WASH RESIDUE WITH WATER. WEAR PROTECTIVE EQUIPMENT TO AVOID OVEREXPOSURE. Waste Disposal Methods: DISPOSAL SHOULD BE MADE IN ACCORDANCE WITH ALL APPLICABLE FEDERAL, STATE AND LOCAL LAWS AND REGULATIONS. PER MFR PRODUCT CAN BE INCINERATED AT AN APPROVED FACILITY. Handling And Storage Precautions: STORE IN A COOL, DRY, WELL VENTILATED AREA. KEEP CONTAINERS TIGHTLY CLOSED WHEN NOT IN USE. PROTECT CONTAINERS FROM PHYSICAL DAMAGE. Other Precautions: AVOID CONTACT WITH EYES, SKIN AND CLOTHING. USE WITHADEQUATE VENTILATION. WASH THOROUGHLY AFTER HANDLING. ======================================================= Fire and Explosion Hazard Information ======================================================= Extinguishing Media: USE WATER FOG, CARBON DIOXIDE, FOAM, OR DRY CHEMICAL. Fire Fighting Procedures: WEAR FIRE FIGHTING PROTECTIVE EQUIPMENT AND A FULL FACED SELF CONTAINED BREATHING APPARATUS. COOL FIRE EXPOSED CONTAINERS WITH WATER SPRAY. Unusual Fire/Explosion Hazard: COMBUSTION OR HEAT OF FIRE MAY PRODUCE HAZARDOUS DECOMPOSITION PRODUCTS AND VAPORS.AS WITH ANY ORGANIC DUST, THERE IS POTENTIAL FOR EXPLOSION WHEN SUSPENDED AIR ======================================================= Control Measures ======================================================= Respiratory Protection: IF VENTILATION DOES NOT MAINTAIN INHALATION EXPOSURES BELOW PEL(TLV), USE NIOSH APPROVED ORGANIC VAPOR CARTRIDGE AND DUST/MIST PRE-FILTER RESPIRATORS AS PER CURRENT 29 CFR 1910.134, INSTRUCTIONS/WARNINGS AND NIOSH-RESPIRATOR SELECTION. Ventilation: MECHANICAL (GENERAL) ROOM VENTILATION IS NORMALLY ADEQUATE. LOCAL EXHAUST MAY BE REQUIRED IF WORK AREA NOT VENTED. Protective Gloves: NEOPRENE, NITRILE, PVC OR NATURAL RUBBER Eye Protection: SAFETY GOGGLES. Other Protective Equipment: EYE WASH STATION. INDUSTRIAL-TYPE WORK CLOTHING AND APRON AS REQUIRED. Work Hygienic Practices: OBSERVE GOOD PERSONAL HYGIENE PRACTICES AND RECOMMENDED PROCEDURES. DO NOT WEAR CONTAMINATED CLOTHING OR FOOTWEAR. Supplemental Safety and Health: AVOID PROLONGED OR REPEATED EXPOSURE. DO NOT GET ON SKIN OR IN EYES. DO NOT BREATHE VAPORS OR MISTS UNLESS ADVISED BY A DOCTOR. ======================================================= Physical/Chemical Properties ======================================================= HCC: N1 Decomp Text: UNKNOWN Solubility in Water: 25% W/V Appearance and Odor: CLEAR, COLORLESS TO LIGHT YELLOW SOLUTION, ODORLESS Corrosion Rate: UNKNOWN ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Stability Condition To Avoid: HIGH HEAT, OPEN FLAMES AND OTHER SOURCES OF IGNITION Materials To Avoid: STRONG OXIDIZING AGENTS Hazardous Decomposition Products: CARBON MONOXIDE, CARBON DIOXIDE AND TOXIC OXIDES OF NITROGEN. Hazardous Polymerization Indicator: NO ======================================================= Toxicological Information ======================================================= Toxicological Information: ALBUTEROL CAUSES BIRTH DEFECTS IN MICE.THERE IS NO EVIDENCE THAT THE PRODUCT IS MUTAGENIC OR CAUSES INFERTILITY IN STANDARD TESTS. ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= Transport Information: NOT REGULATED. ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= Transportation Information ======================================================= Responsible Party Cage: 34006 Trans ID NO: 149384 Product ID: VENTOLIN (ALBUTEROL SULATE) INHALATION SOLUTION, 0.5% MSDS Prepared Date: 03/17/1997 Review Date: 10/20/1999 MFN: 2 Net Unit Weight: 20 ML BT Multiple KIT Number: 0 Unit Of Issue: BT Additional Data: NOT REGULATED PER MSDS. ======================================================= Detail DOT Information ======================================================= DOT PSN Code: ZZZ DOT Proper Shipping Name: NOT REGULATED BY THIS MODE OF TRANSPORTATION ======================================================= Detail IMO Information ======================================================= IMO PSN Code: ZZZ IMO Proper Shipping Name: NOT REGULATED FOR THIS MODE OF TRANSPORTATION ======================================================= Detail IATA Information ======================================================= IATA PSN Code: ZZZ IATA Proper Shipping Name: NOT REGULATED BY THIS MODE OF TRANSPORTATION ======================================================= Detail AFI Information ======================================================= AFI PSN Code: ZZZ AFI Proper Shipping Name: NOT REGULATED BY THIS MODE OF TRANSPORTATION ======================================================= HAZCOM Label ======================================================= Product ID: VENTOLIN (ALBUTEROL SULATE) INHALATION SOLUTION, 0.5% Cage: 34006 Company Name: GLAXO WELLCOME INC. Street: 5 MOORE DR City: DURHAM NC Zipcode: 27709 Health Emergency Phone: 919-248-2100/2700 Label Required IND: Y Date Of Label Review: 10/20/1999 Status Code: A Origination Code: F Signal Word: WARNING Health Hazard: Moderate Contact Hazard: Moderate Fire Hazard: None Reactivity Hazard: None Hazard And Precautions: EYES & RESPIRATORY TRACT IRRITATION. ALBUTEROL IS A B2-ADRENEGIC BRONCHODILATOR AND MAY CAUSE MUSCULAR TREMOR, MUSCLE CRAMPS, NAUSEA AND VOMITING, HEADACHE, NERVOUSNESS, DIZZINESS, RAPID PULSE, ELEVATED BLOOD PRESSURE. HYPERSENSITIVITY REAC TIONS, SUCH AS HIVES, SKIN RASH, DIFFICULTY IN BREATHING, SWELLING OF SKIN HAVE BEEN REPORTED.FIRST AID-INHALATION:REMOVE TO FRESH AIR. GET MEDICAL ATTENTION. EYES: FLUSH WITH WATER FOR 15 MINUTES HOLDING EYELIDS OPEN. GET MEDICAL ATTENTIO N. SKIN: WASH WITH SOAP AND WATER. IF IRRITATION PERSISTS, GET MEDICAL ADVICE. INGESTION: RINSE MOUTH WITH WATER IF CONSCIOUS. GET IMMEDIATE MEDICAL ATTENTION. ======================================================= Disclaimer (provided with this information by the compiling agencies): This information is formulated for use by elements of the Department of Defense. The United States of America in no manner whatsoever expressly or implied warrants, states, or intends said information to have any application, use or viability by or to any person or persons outside the Department of Defense nor any person or persons contracting with any instrumentality of the United States of America and disclaims all liability for such use. Any person utilizing this instruction who is not a military or civilian employee of the United States of America should seek competent professional advice to verify and assume responsibility for the suitability of this information to their particular situation regardless of similarity to a corresponding Department of Defense or other government situation.