===================== Product Identification =====================
MSDS NAME:CYTOXAN FOR INJECTION 100 MG/VIAL
NIIN:00F039415
MSDS Number: BWWXZ
=== Responsible Party ===
Company:BRISTOL-MYERS SQUIBB, PHARMACEUTICAL GRP
Address:5 GORDIS RD BLDG 124
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903-5000
Country:US
Info Phone Num:800-332-2056/908-519-3843
Emergency Phone Num:908-519-3843/609-921-4081
CAGE:BRIST
=== Contractor Identification ===
Company:BRISTOL-MYERS SQUIBB PHARMACEUTICAL GROUP
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903
Country:US
Phone:908-519-2385
CAGE:BRIST
Company:E R SQUIBB MEDATOPE DIV
Address:5 GORDIS RD BLDG 124
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903
Country:US
Phone:609-921-4081
CAGE:4T649
============= Composition/Information on Ingredients =============
Name:CYCLOPHOSPHAMIDE HYDRATE (HUMAN & ANIMAL CARCINOGEN BY
IARC) *95-1*
CAS:6055-19-2
RTECS #:RP6157750
Fraction by Wt: 70%
Name:SODIUM CHLORIDE
CAS:7647-14-5
RTECS #:VZ4725000
Fraction by Wt: >1%
===================== Hazards Identification =====================
LD50 LC50 Mixture:ORAL LD50 (RAT): 94 MG/KG (SEE SUPP)
Routes of Entry: Inhalation:YES Skin:YES Ingestion:YES
Reports of Carcinogenicity:NTP:NO IARC:YES OSHA:NO
Health Hazards Acute and Chronic:INHALATION/SKIN/INGESTION: SYSTEMIC
ABSORPTION. SKIN: DELAYED BONE MARROW SUPPRESSION & POSSIBLY
CARDIOTOXICITY. EYES: CONJUNTIVITIS. MAY AFEECT THE GI TRACT,
KIDNEYS, LUNGS, REPRODUCTIVE SYSTEM & HEA RT. THIS DRUG MAY BE
HARMFUL TO THE FETUS. CYCLOPHOSPHAMIDE-BONE MARROW SUPPRESSION,
CARDIOTOXICITY. (SEE SUPP)
Explanation of Carcinogenicity:SEE INGREDIENTS. ACCORDING TO
BRISTOL-MEYERS, CYCLOPHOSPHAMIDE IS A NTP HUMAN CARCINOGEN.
Effects of Overexposure:NAUSEA, VOMITING, ANOREXIA, HEADACHE,
DIZZINESS, RASH. CYCLOPHOSPHAMIDE: NAUSEA, VOMITING, ANOREXIA,
DIARRHEA, HEADACHE, DIZZINESS. SODIUM CHLORIDE: IRRITATION,
SNEEZING, COUGH, DIFFICULTY BREATHING, TIGHTNESS OF CHEST,
REDNESS, TEARING, SWELLING, PAIN.
Medical Cond Aggravated by Exposure:LOW PLATELET/LEUKOCYTE COUNTS,
COAGULATION DISORDERS, RENAL/PULMONARY/CARDIAC DISEASES, RECENT
RADIATION/CHEMOTHERAPY.
======================= First Aid Measures =======================
First Aid:INGESTION: INDUCE VOMITING IF CONSCIOUS & NOT CONVULSING.
INHALATION: REMOVE TO FRESH AIR. GIVE CPR/OXYGEN IF NEEDED.
SKIN/EYES: FLUSH W/PLENTY OF WATER FOR 15 MINS. OBTAIN MEDICAL
ATTENTION IN ALL CA SES. NOTE TO PHYSICIAN: WHEN
ADMINISTEDPARENTERALLY, IT'S HIGHLY TOXIC W/A LOW THERAPUTIC INDEX.
===================== Fire Fighting Measures =====================
Extinguishing Media:WATER, CO2, FOAM, DRY CHEMICAL.
Fire Fighting Procedures:WEAR SCBA & FULL PROTECTIVE EQUIPMENT.
EVACUATE PERSONNEL UPWIND. REMOVE UNNEEDED MATERIAL & COOL
CONTAINERS W/WATER FROM A MAXIMUM DISTANCE.
Unusual Fire/Explosion Hazard:FINE DUSTS SUSPENDED IN AIR IN SUFFICIENT
CONCENTRATION & IN PRESENCE OF AN IGNITION SOURCE MAY POSE A
POTENTIAL EXPLOSION HAZARD.
================== Accidental Release Measures ==================
Spill Release Procedures:ISOLATE AREA & WEAR SUITABLE PROTECTIVE
EQUIPMENT. COLLECT W/PAPER TOWELING & MOISTEN PRIOR TO PICK UP TO
MINIMIZE DUST GENERATION. CLEAN AREA USING SEVERAL WASHES
W/DETERGENT & WATER. TREAT PRODUCT/C ONTAMINATED MATERIALS AS
HAZARDOUS WASTE.
====================== Handling and Storage ======================
Handling and Storage Precautions:STORE AT/<77F. PROTECT FROM TEMPS
EXCEEDING 86F. DON'T BREAK VIALS/SPILL CONTENTS. MINIMIZE DUST
GENERATION.
Other Precautions:AVOID INHALATION/INGESTION/SKIN CONTACT.
DECONTAMINATE PROTECTIVE EQUIPMENT AFTER USE. PROVIDE APPROPRIATE
BONDING & GROUNDING PROTECTION TO CONTROL STATIC CHARGES.
============= Exposure Controls/Personal Protection =============
Respiratory Protection:WEAR A NIOSH APPROVED DUST RESPIRATOR W/HIGH
EFFICIENCY DUST FILTER/POWERED AIR-PURIFYING RESPIRATOR WHEN
ENGINEERING CONTROLS AREN'T SUFFICIENT TO CONTROL EXPOSURE. WEAR
SELF CONTAINED BREATHING APPA RATUS IN EMERGENCIES.
Ventilation:LOCAL MECHANICAL EXHAUST: EXPLOSION PROOF. BIOLOGICAL
CABINET SHOULD BE USED FOR PREPARATION OF THIS DRUG.
Protective Gloves:DISPOSABLE SURGICAL LATEX
Eye Protection:CHEMICAL SAFETY GOGGLES
Other Protective Equipment:IMPERVIOUS DISPOSABLE COVERALLS W/CLOSED
FRONT, LONG SLEEVES & ELASTIC CUFFS, BOOTS, EXPLOSION PROOF
EQUIPMENT.
Work Hygienic Practices:REMOVE/LAUNDER CONTAMINATED CLOTHING BEFORE
REUSE. WASH THOROUGHLY AFTER HANDLING.
Supplemental Safety and Health
SOLUBILITY, PH, VAPOR DENSITY & ORAL LD50 INFORMATION IS FOR
CYCLOPHOSPHAMIDE MONOHYDRATE. HEALTH HAZARDS CONT'D:
CYCLOPHOSPHAMIDE-GI EFFECTS/CYSTITIS/KIDNEY
DAMAGE/ALOPECIA/PULMONARY FIBROSIS/CHANGES IN
METABOLISM/CARDIOTOXICITY/POSITIVE FOR MUTAGENICITY &
TERATOGEN/GONADAL SUPPRESSION/PERMANENT STERILITY.
================== Physical/Chemical Properties ==================
Melt/Freeze Pt:M.P/F.P Text:106-113F
Vapor Density:>1 (SUPP)
pH:3-7.5
Solubility in Water:40 MG/ML (SEE SUPP)
Appearance and Odor:VIAL CONTAINS WHITE POROUS CAKE-LIKE SOLID W/NO
ODOR.
================= Stability and Reactivity Data =================
Stability Indicator/Materials to Avoid:YES
STRONG OXIDIZERS.
Stability Condition to Avoid:TEMPS >86F, IGNITION SOURCES.
Hazardous Decomposition Products:CO, CO2, CHLORINE, HYDROGEN CHLORIDE,
OXIDES OF NITROGEN & PHOSPHOROUS, PHOSPHINE.
Conditions to Avoid Polymerization:TEMPS >120.2F.
==================== Disposal Considerations ====================
Waste Disposal Methods:DISPOSE OF IAW/FEDERAL, STATE & LOCAL
REGULATIONS. SHOULD BE INCINERATED AT AN APPROVED FACILITY.
POISONOUS UN2811.
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.
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