SCHERING PLOUGH CORPORATION -- RIBAVIRIN -- - ===================== Product Identification ===================== Product ID:RIBAVIRIN MSDS Date:04/27/1998 FSC:NIIN:Submitter:N EN Status Code:A MSDS Number: CLHKJ === Responsible Party === Company Name:SCHERING PLOUGH CORPORATION Address:2000 GALLOPING HILL ROAD City:KENILWORTH State:NJ ZIP:07033 Country:US Info Phone Num:908-298-4632 Emergency Phone Num:908-298-4632 CAGE:UO117 === Contractor Identification === Company Name:SCHERING PLOUGH CORPORATION Address:2000 GALLOPING HILL ROAD Box:City:KENILWORTH State:NJ ZIP:07033 Country:US Phone:908-298-4632 CAGE:UO117 ============= Composition/Information on Ingredients ============= Ingred Name:RIBAVIRIN. (CHEMICAL NAME: 1-BETA-D-RIBOFURANOSYL-1 H-1, 2, 2, 4-TRIAZOL-3-CARBOXAMIDE) CAS:36791-04-5 RTECS #:XZ4250000 Other REC Limits:5 MCG/M3 OEG OSHA PEL:NONE ACGIH TLV:NONE ===================== Hazards Identification ===================== LD50 LC50 Mixture:LD50/RAT-ORAL: 5300MG/KG; MOUSE1300MG/KG Routes of Entry: Inhalation:YES Skin:YES Ingestion:YES Reports of Carcinogenicity:NTP:NO IARC:NO OSHA:NO Health Hazards Acute and Chronic:EMERGENCY OVERVIEW: RIBAVIRIN IS AN ANTIVIRAL AGENT, TYPICALLY INDICATED IN TREATMENT OF VIRAL RESPIRATORY TRACT INFECTIONS. CAUTION: SUBSTANCE NOT FULLY TESTED. MAY CAUSE HARM TO UNBORN CHILD. POT ENTIAL HEALTH EFFECTS: EYES: MAY CAUSE IRRITATION. SKIN: MAY CAUSE IRRITATION OR SENSITIZATION. TERATOGENICITY (BIRTH DEFECTS) RIBAVARIN IS TERATOGENIC IN SEVERAL DIFFERENT ANIMAL SPECIES. REPRODUCTIV E EFFECTS: RIBAVARIN HAS SHOWN TERATOGENIC EFFECTS AND OTHER ADVERSE EFFECTS ON REPRODUCTIVE FUNCTION IN TEST ANIMALS. MUTAGENIC (GENETIC EFFECTS): THE STUDIES FOR MUTAGENICITY IN ANIMALS ARE EQUIVOCA L. (SIGNS & SYMPTOMS OF OVEREXPOSURE) Effects of Overexposure:SIGNS AND SYMPTOMS OF EXPOSURE BASED ON HUMAN EXPERIENCE INCLUDE HEADACHE AND PAIN IN EYES ON CONTACT; SKIN IRRITATION (RASHES, REDNESS). HEALTH HAZARDS ACUTE & CHRONIC (CONT): ACUTE INHALATION EF FECTS: ADVERSE CARDIOVASCULAR EFFECTS INCLUDING CARDIAC ARREST, HYPOTENSION AND CARDIAC GLYCOSIDE INTOXICATION HAVE BEEN ASSOCIATED WITH RIBAVIRIN INHALATION. SUCHRONIC (TARGET ORGAN EFFECTS): BLOOD FORMING SYSTEMS - RIBAVARIN AND OR ITS METABOLITES ACCUMULATE IN RED BLOOD CELLS AND PERSIST FOR ENTENDED PERIODS FOLLOWING EXPOSURE. RIBAVARIN PRODUCES DOSE AND TIME DEPENDENT REVERSIBLE ANEMIA, POSS IBLY RESULTING FROM (TOXICOLOGICAL INFO) Medical Cond Aggravated by Exposure:HYPERSENSITIVITY TO THE MATERIAL. ======================= First Aid Measures ======================= First Aid:EYES: FLUSH WITH WATER FOR AT LEAST 15 MINUTES. OBTAIN MEDICAL ATTENTION. SKIN: REMOVE CONTAMINATED CLOTHING. THROUGHLY WASH EXPOSED SKIN WITH SOAP AND WATER. OBTAIN MEDICAL ATTENTION. INGESTION: GIVE COPIOUS AMOUNTS OF WATER AND INDUCE VOMITING, IF CONSCIOUS. OBTAIN MEDICAL ATTENTION. INHALATION: REMOVE FROM EXPOSURE. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. OBTAIN MEDICAL ATTENTION. IN CA SE OF ACCIDENT OR IF YOU FEEL UNWELL, SEEK MEDICAL ADVICE IMMEDIATELY. ===================== Fire Fighting Measures ===================== Flash Point:N/AP F Autoignition Temp:Autoignition Temp Text:N/AP F Extinguishing Media:WATER, WATER SPRAY, CO2, DRY CHEMICAL. Fire Fighting Procedures:FIGHT FIRE FROM SAFE DISTANCE OR PROTECTED LOCATION. USE WATER SPRAY TO KEEP EXPOSED CONTAINERS AND EQUIPMENT COOL. WEAR FULL PROTECTIVE CLOTHING AND (NIOSH APPROVED - ) SELF CONTAINED BREATHING A PPARATUS (SCBA). Unusual Fire/Explosion Hazard:UNDER NORMAL CONDITIONS OF USE THIS MATERIAL DOES NOT PRESENT A SIGNIFICANT FIRE OR EXPLOSION HAZARD. HOWEVER, LIKE MOST ORGANIC COMPOUNDS IT IS COMBUSTIBLE AND MAY FORM A DUST EXPLOSION IF WIDELY DIS PERSED IN AIR. ================== Accidental Release Measures ================== Spill Release Procedures:FLOOR SWEEPING IS NOT PERMITTED FOR CLEANING POWDERS. CAREFULLY VACUUM UP SPILL USING A HEPA FILTERED VACUUM, PRIOR TO WET MOPPING/CLEANING. MINIMIZE CONTACT WITH SPILLED MATERIAL. KEEP OTHER PERSONNE L AWAY FROM THE CLEAN UP AREA. WEAR APPROPRIATE RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING IN THE SPILL AREA AS SPECIFIED IN (EXPOSURE CONTROLS) SECTION. NOTIFY YOUR SUPERVISOR (STATE REGULATORY) ====================== Handling and Storage ====================== Handling and Storage Precautions:HANDLING PRECAUTIONS: OPEN HANDLING IS LIMITED TO SMALL QUANTITIES. FUME HOODS AND OTHER OPEN-FACE CONTAINMENT DEVICES ARE ACCEPTABLE WHEN FACE VELOCITIES OF AT LEAST 80 FPM ARE ACHIEVED. PARTITIONS, BARRIERS, AND OTHER PARTIAL CONTAINMENT TECHNOLOGIES ARE REQUIRED TO PREVENT (OTHER PRECAUTIONS) Other Precautions:HANDLING & STORAGE PRECAUTIONS (CONT): OF THE COMPOUND TO UNCONTROLLED AREAS. STORAGE PRECAUTIONS: STORE IN DOUBLE LINED PLASTIC IN FIBREBOARD OR OTHER APPROPRIATE CONTAINER. IT IS SUGGESTED THAT A DOUBLE BAGGING SYSTEM BE USED TO MINIMIZE EXPOSURE. KEEP CONTAINER TIGHTLY CLOSED IN A COOL WELL VENTILATED PLACE. ============= Exposure Controls/Personal Protection ============= Respiratory Protection:(NIOSH APPROVED - ) POWERED AIR PURIFYING RESPIRATOR WITH HEPA CARTRIDGES, OR POSITIVE PRESSURE FULL FACE AIR SUPPLIED RESPIRATOR. Ventilation:A MINIMUM OF 10 AIR CHANGES PER HOUR IS RECOMMENDED. AIR-RECIRCULATION MAY BE PERMITTED IN LIMITED SITUATIONS. AIR FLOW MUST BE DIRECTED AWAY FROM (SARA III) Protective Gloves:LATEX. DOUBLE GLOVING IS SUGGESTED. Eye Protection:(ANSI APPROVED - ) SAFETY GOGGLES OR FULL FACE RESPIRATORY PROTECTION. Other Protective Equipment:SINGLE USE TYVEK PROTECTIVE CLOTHING. EYEWASH AND DELUGE SHOWER MEETING ANSI DESIGN CRITERIA . Work Hygienic Practices:CONTROLLED ACCESS TO THE WORK AREA IS RECOMMENDED. ONLY THOSE PERSONS WHO HAVE RECEIVED TRAINING SPECIFIC TO THE COMPOUND SHOULD BE ADMITTED. WORK SURFACES AND EQUIPMENT (SUPPLEMENTAL SAFETY & HEALTH) Supplemental Safety and Health WORK HYGENIC PRACTICES (CONT): SHOULD BE DECONTAMINATED AFTER ALL POTENTIAL HIGH RISK ACTIVITIES. EATING, DRINKING, SMOKING, AND APPLYING COSMETICS ARE NOT PERMITTED IN THE WORK AREA. USE INDICATED PE RSONAL PROTECTIVE EQUIPMENT WHILE HANDLING. AVOID EXPOSURE. OBTAIN SPECIAL INSTRUCTIONS BEFORE USE. DO NOT BREATHE DUST ================== Physical/Chemical Properties ================== Boiling Pt:B.P. Text:N/A C Melt/Freeze Pt:=166.C, 330.8F M.P/F.P Text:MELTING POINT pH:4.2 @ 100 G/L C Solubility in Water:111 GM/LITER Appearance and Odor:SOLID, WHITE CRYSTALLINE POWDER. ODOR: NONE SPECIFIED BY MANUFACTURER . ================= Stability and Reactivity Data ================= Stability Indicator/Materials to Avoid:YES OXIDIZING AGENTS. Hazardous Decomposition Products:CARBON MONOXIDE AND NOX. =================== Toxicological Information =================== Toxicological Information:SIGNS & SYMPTOMS OF OVEREXPOSURE (CONT): HEMOLYSIS OF ERYTHROCYTES AND INHIBITION OF LATE STAGES OF ERYTHROCYTE DEVELOPMENT IN BONE MARROW. TERATOGENIC (BIRTH DEFECTS): RIBAVIRIN HAS BEEN SHOWN TO B E TERATOGENIC IN ALMOST ALL ANIMAL SPECIES TESTED TO DATE. REPRODUCTIVE EFFECTS: MAY CAUSE FETAL TOXICITY. TOXIC TO LACTATING ANIMALS AND THEIR OFFSPRING. RIBAVIRIN CAUSED TESTICULAR ATROPHY IN MIC E AT A LOW DOSE RATE OF 16 MG/KG/DAY; THIS EFFECT WAS REVERSIBLE UNDER CESSATION OF EXPOSURE. MUTAGENICITY: THE MUTAGENICITY OF RIBAVIRIN IN ANIMALS IS QUESTIONABLE. IN BALB / 3T3 TRANSFORMATION ASS AY, THERE WAS (ECOLOGICAL INFO) ===================== Ecological Information ===================== Ecological:ECOLOGICAL EFFECTS OR OTHER ECOLOGICALLY DAMAGING PROFILE ARE UNKNOWN. BACTERIA TOXICITY: EC50 GREATER THAN OR EQUAL TO 10,000 MG/L (VIRBRIO) TOD 1187 MG 02/GRAM. TOXICOLOGICAL INFO (CONT): INC REASED TRANSFORMATIONS AT THE HIGHEST DOSE. THERE WAS NO EVIDENCE OF DOSE RESPONSE. IN THE MOUSE LYMPHOMA ASSAY, RIBAVIRIN PRODUCED A DOSE-RELATED INCREASE IN MUTANT FREQUENCIES. IN A DOMINANT LETHAL ASSAY, RIBAVIRIN DID NOT INDUCE EFFECTS EXPRESSED AS DOMINANT LETHALITY WHEN MALE MALE RATS WERE EXPOSED TO MAXIMUM TOLERATED DOSES. MISCELLANEOUS TOXICOLOGICAL INFORMATION: ACUTE TOXICITY DATA: LD5 0 RAT ORAL: 5300 MG/KG. (TRANSPORT INFO) ==================== Disposal Considerations ==================== Waste Disposal Methods:MATERIAL SHOULD BE DISPOSED IN AN ENVIRONMENTALLY SOUND MANNER (I.A.W APPLICABLE REGULATIONS - FPN). INCINERATION IS THE PREFERRED DISPOSAL METHOD. ALL WASTE MATERIAL SHOULD BE DOUBLE BAGGED AND PLAC ED IN A CLEARLY LABELED RIDGID CONTAINER ACCORDING TO LOCAL APPLICABLE STANDARDS. MATERIAL SHOULD NO T BE CRUSHED OR SHREDDED PRIOR TO FINAL DISPOSAL. =================== MSDS Transport Information =================== Transport Information:PROPER SHIPPING NAME: NOT CLASSIFIED FOR TRANSPORT. ECOLOGICAL INFO (CONT): LD50 MOUSE, INTRAPERITONEAL: 1300 MG/KG. TDLO RAT, ORAL: 25 MG/KG; TDLO HAMSTER: 2500 UG/KG. RIBAVIRIN HAS SHOWN TERA TOGENIC EFFECTS IN MULTIPLE ANIMAL SPECIES. THIS DATA SUGGESTS A SIGNIFICANT RISK OF TERATOGENICITY IN HUMANS. EXPERIENCE IN HUMANS: HEADACHE AND PAIN IN THE EYES ON CONTACT; SKIN IRRITATION. EXPOSU RE LIMITS: SHERING OEG: 5 MCG/M3. SURFACE LEVEL: 50 MCG/ 100 CM2. ===================== Regulatory Information ===================== SARA Title III Information:N/P. VENTILATION (CONT): THE OPERATOR'S BREATHING ZONE. AIR PRESSURE SHOULD BE NEGATIVETO SURROUNDING AREAS. LOCAL EXHAUST VENTILATION MUST BE PROVIDED AT THE SOURCES OF CONTAMINATION. SURFAC ES SHOULD BE SMOOTH, NON-POROUS, WITH MINIMAL LEDGES AND EASILY CLEANED. Federal Regulatory Information:EUROPEAN (ECC) REGULATORY INFORMATION: LABELING INFORMATION: HEALTH HARMFUL SYMBOL "XN". R PHRASES: R39/23/24/25: SERIOUS DANGER OF IRREVERSIBLE DANGER IF INHALED, AFTER CONTACT WITH SKIN, IF SWALLOWE D. R62: MAY CAUSE HARM TO UNBORN CHILD. R63: POSSIBLE RISK OF IMPAIRED FERTILITY. S PHRASES: S1: KEEP LOCKED UP. S13: KEEP AWAY FROM FOOD, DRINK AND ANIMAL FEED. S20/21: DO NOT EAT, DRINK OR SMOKE WHI LE WORKING. S36/37/39: WEAR SUITABLE PROTECTIVE CLOTHING, PROTECTIVE GLOVES, PROTECTIVE GOGGLES/FAC E PROTECTION WHILE WORKING. S3/7: KEEP CONTAINER TIGHTLY CLOSED AND STORE IN A COOL PLACE. State Regulatory Information:N/P. SPILL RELEASE PROCEDURES (CONT): IMMEDIATELY. DISPOSE OF SPILLED MATERIAL AND CLEAN UP MATERIALS AS NOTED IN (WASTE DISPOSAL) SECTION. ======================= Other Information ======================= 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 this information to be accurate and disclaims all liability for its use. Any person utilizing this document should seek competent professional advice to verify and assume responsibility for the suitability of this information to their particular situation.