FUJISAWA PHARMACEUTICAL CO -- VINCRISTINE SULFATE INJECTION ======================================================= MSDS Safety Information ======================================================= FSC: 6505 MSDS Date: 01/01/1994 MSDS Num: BTJWC LIIN: 00FO34726 Product ID: VINCRISTINE SULFATE INJECTION MFN: 01 Responsible Party Cage: EO410 Name: FUJISAWA PHARMACEUTICAL CO Address: PARKWAY NORTH CENTER, 3 PARKWAY N City: DEERFIELD IL 60015-2548 Info Phone Number: 708-317-0800 Emergency Phone Number: 800-888-7704 Preparer's Name: CHRISTINA J. BARRINGTON Review Ind: Y Published: Y ======================================================= Contractor Summary ======================================================= Cage: EO410 Name: FUJISAWA PHARMACEUTICAL CO Address: PARKWAY NORTH CENTER, 3 PARKWAY N City: DEERFIELD IL 60015-2548 Phone: 708-317-0800 Cage: 0K706 Name: FUJISAWA USA, INC. Address: 3 PARKWAY NORTH City: DEERFIELD IL 60015-2548 Phone: 708-317-0800 OR 800-888-7704 ======================================================= Ingredients ======================================================= Cas: 7732-18-5 RTECS #: ZC0110000 Name: WATER (PH ADJUSTED) % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 2068-78-2 RTECS #: OH6340000 Name: VINCRISTINE SULFATE (1 MG/ML) % Wt: UNKNOWN Other REC Limits: NONE SPECIFIED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 99-76-3 RTECS #: DH2450000 Name: METHYLPARABEN (1.3 MG/ML) % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ------------------------------ Cas: 94-13-3 RTECS #: DH2800000 Name: PROPYLPARABEN (0.2 MG/ML) % Wt: UNKNOWN Other REC Limits: NONE RECOMMENDED OSHA PEL: NOT ESTABLISHED ACGIH TLV: NOT ESTABLISHED ======================================================= Health Hazards Data ======================================================= LD50 LC50 Mixture: INTRAVENOUS LD50 (RAT) IS 2.1 MG/KG Route Of Entry Inds - Inhalation: YES Skin: YES Ingestion: YES Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: THIS PRODUCT IS INTENDED FOR THERAPUTIC USE ONLY WHEN PRESCRIBED BY A PHYSICIAN. POTENTIAL ADVERSE REACTIONS FROM PRESCRIBED DOSES AND OVERDOSES ARE DESCRIBED IN THE PACKAGE INSERT. OCCUPATIONAL EXPOS URE HAS NOT BEEN FULLY INVESTIGATED. Explanation Of Carcinogenicity: VINCRISTINE IS LISTED BY IARC MONOGRAPHS AS CLASS 3, UNCLASSIFIABLE. Signs And Symptions Of Overexposure: EYE, SKIN, AND RESPIRATORY IRITATION, BONE MARROW SUPPRESSION, LOSS OF HAIR (ALOPECIA) AND NAUSEA MAY OCCUR. DIRECT EYE CONTACT CAN LEAD TO SEVERE IRRITATION & ULCERATION. EXTRAVASATION MAY CAUSE TISS UE IRRITATION & DAMAGE. Medical Cond Aggravated By Exposure: PRE-EXISTING SKIN & RESPIRATORY CONDITIONS. First Aid: EYE:FLUSH W/WATER 15 MIN. SEEK MEDICAL ATTENTION. SKIN:REMOVE CONTAMINATED CLOTHING IMMEDIATELY. FLUSH AREA W/WATER FOR 15 MIN. SEEK MEDICAL ATTENTION. INHALED:REMOVE TO FRESH AIR. AID/RESTORE BREA THING IF NECESSARY. SEEK MEDICAL ATTENTION. INGESTED:FLUSH OUT MOUTH WITH WATER IMMEDIATELY. SEEK MEDICAL ATTENTION. FOR ADVERSE DRUG REACTION INFORMATION CALL 708-317-5937. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: WEAR RECOMMENDED PERSONAL PROTECTIVE EQUIPMENT. USE ABSORBENT TOWELS OR BOOMS TO CLEAN UP SPILL. WIPE SURFACES CLEAN AND WASH WITH SOAP AND WATER. Neutralizing Agent: NO INFORMATION GIVEN ON MSDS BY MFR. Waste Disposal Methods: DISPOSE OF IN ACCORDANCE WITH FEDERAL, STATE AND LOCAL REGULATIONS. Handling And Storage Precautions: WHEN HANDLING PHARMACEUTICAL PRODUCTS, AVOID ALL CONTACT AND INHALATION OF DUST, FUMES, MIST ANDOR VAPORS ASSOCIATED WITH THE PRODUCT. Other Precautions: NONE ======================================================= Fire and Explosion Hazard Information ======================================================= Flash Point Method: CC Flash Point Text: >200F,>93C Lower Limits: UNKNOWN Upper Limits: UNKNOWN Extinguishing Media: WATER SPRAY, DRY CHEMICAL, CARBON DIOXIDE OR FOAM AS APROPIATE. Fire Fighting Procedures: WEAR SELF-CONTAINED BREATHING APPARATUS AND PROTECTIVE CLOTHING. Unusual Fire/Explosion Hazard: NO INFORMATION GIVEN ON MSDS BY MFR. ======================================================= Control Measures ======================================================= Respiratory Protection: WITH SATISFACTORY VENTILATION, RESPIARATORY PROTECTION IS NOT USUALLY REQUIRED. Ventilation: GENERAL ROOM VENTILATION IS USUALLY SATISFACTORY. USE LOCAL EXHAUST WHEN NECESSARY. Protective Gloves: DISPOSABLE LATEX GLOVES RECOMMENDED. Eye Protection: SAFETY GLASSES OR GOGGLES RECOMMENDED. Other Protective Equipment: DISPOSABLE GARMENTS IF DIRECT SKIN CONTACT IS ANTICIPATED. Work Hygienic Practices: WASH AFTER HANDLING AND BEFORE EATING, DRINKING, OR SMOKING. Supplemental Safety and Health: NONE ======================================================= Physical/Chemical Properties ======================================================= HCC: K2 NRC/State LIC No: NONE B.P. Text: UNKNOWN M.P/F.P Text: UNKNOWN Decomp Text: UNKNOWN Vapor Pres: UNKNOWN Vapor Density: UNKNOWN Spec Gravity: UNKNOWN PH: 4-5 Evaporation Rate & Reference: UNKNOWN Solubility in Water: FREELY SOLUBLE Appearance and Odor: CLEAR COLORLESS, ODORLESS SOLUTION. Corrosion Rate: UNKNOWN ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Stability Condition To Avoid: EXPOSURE TO EXCESS LIGHT OR HEAT MAY CAUSE DECOMPOSITION. Materials To Avoid: NO INFORMATION GIVEN ON MSDS BY MFR. Hazardous Decomposition Products: WHEN HEATED TO DECOMPOSITION IT EMITS TOXIC FUMES OF SOX AND NOX. Hazardous Polymerization Indicator: NO Conditions To Avoid Polymerization: WILL NOT OCCUR ======================================================= Toxicological Information ======================================================= ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= Transportation Information ======================================================= Responsible Party Cage: EO410 Trans ID NO: 8422 Product ID: VINCRISTINE SULFATE INJECTION MSDS Prepared Date: 01/01/1994 Review Date: 06/15/1994 MFN: 1 AF MMAC Code: NR Multiple KIT Number: 0 Review IND: Y Additional Data: PROPER SHIPPING NAME SUPPLIED BY MFR. ======================================================= 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: VINCRISTINE SULFATE INJECTION Cage: EO410 Assigned IND: Y Company Name: FUJISAWA PHARMACEUTICAL CO Street: PARKWAY NORTH CENTER, 3 PARKWAY N City: DEERFIELD IL Zipcode: 60015-2548 Health Emergency Phone: 800-888-7704 Date Of Label Review: 06/15/1994 Status Code: C MFG Label NO: NONE Label Date: 06/15/1994 Origination Code: Z Hazard And Precautions: LABEL IS SPECIFIED BY THE FDA, NOT OSHA! ======================================================= 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.