Product ID:CYTOXAN TABLETS 50 MG
MSDS Date:01/24/1994
FSC:6505
NIIN:00-733-5246
MSDS Number: BWKWP

BRISTOL-MYERS SQUIBB, PHARMACEUTICAL GRP

5 GORDIS RD BLDG 124
NEW BRUNSWICK, NJ 08903-5000
US

Emergency Phone: 908-519-3843/609-921-4081

Info Phone: 800-332-2056/908-519-3843

Cage: BRIST

E R SQUIBB MEDATOPE DIV

191 NEW BRUNSWICK, NJ 08903 US

Telephone: 609-921-4081

Cage: 4T649

CYCLOPHOSPHAMIDE HYDRATE (SUSPECTED HUMAN CARCINOGEN BY

CAS: 6055-19-2

RTECS: RP6157750

Fraction By Weight: 9%

LACTOSE

CAS: 63-42-3

RTECS: OD9625000

Fraction By Weight: >1%

STARCH; VANCIDE MZ-96

CAS: 9005-25-8

RTECS: GM5090000

Fraction By Weight: >1%

OSHA PEL 15 MG/CUM TOTAL DUST

ACGIH TLV: 10 MG/CUM TOTAL DUST

GUM ARABIC (ACACIA) *94-4*

CAS: 9000-01-5

RTECS: CE5945000

Fraction By Weight: >1%

STEARIC ACID

CAS: 57-11-4

RTECS: WI2800000

Fraction By Weight: >1%

ACGIH TLV: 10 MG/CUM

TALC (POWDER), (ASBESTOS FREE), TALCUM; HYDROUS MAGNESIUM

CAS: 14807-96-6

RTECS: WW2710000

Fraction By Weight: >1%

OSHA PEL 2 MG/CUM

ACGIH TLV: 2 MG/CUM (RESP DUST)

MAGNESIUM STEARATE

CAS: 557-04-0

RTECS: WI4390000

Fraction By Weight: 1%

ACGIH TLV: 10 MG/CUM

FD & C BLUE NO. 1

CAS: 3844-45-9

RTECS: BQ4725000

Fraction By Weight: <1%

D&C YELLOW NO. 10; ALUMINUM LAKE

CAS: 8004-92-0

RTECS: GC5796000

Fraction By Weight: <1%

LD50 LC50 Mixture:ORAL LD50 (RAT): 94 MG/KG
Routes of Entry: Inhalation:YES Skin:YES Ingestion:YES
Reports of Carcinogenicity:NTP:NO IARC:YES OSHA:NO
Health Hazards Acute and Chronic:INGESTION/INHALATION: DELAYED BONE
MARROW SUPPRESSION/CARDIOTOXICITY/SYSTEMIC ABSORPTION. SKIN:
SYSTEMIC ABSORPTION/MILD IRRITATION/SENSITIZATION. EYES:
CONJUNCTIVITIS. REPEATED SYSTEMIC EXPOSURE MAY CAUSE REVERSIBLE
BONE MARROW SUPPRESSION/GI EFFECTS/KIDNEY DAMAGE/PULMONARY
FIBROSIS/CARDIOTOXICITY. (SEE SUPP)
Explanation of Carcinogenicity:SEE INGREDIENTS
Effects of Overexposure:IRRITATION, NAUSEA, VOMITING, ANOREXIA,
DIARRHEA, HEADACHE, DIZZINESS, RASH, CYSTITIS, ALOPECIA, CHANGES IN
METABOLISM.
Medical Cond Aggravated by Exposure:LOW PLATELET/LEUKOCYTE COUNTS,
COAGULATION DISORDERS, RENAL/PULMONARY/CARDIAC DISEASE.

First Aid:INGESTION: INDUCE VOMITING IF CONSCIOUS & NOT CONVULSIVE.
NEVER GIVE ANYTHING BY MOUTH TO AN UNCONSCIOUS PERSON. SKIN:
IMMEDIATELY FLUSH W/LARGE AMOUNTS OF WATER. USE SOAP IF AVAILABLE.
EYES: FLUSH W/ PLENTY OF WATER FOR 15 MINS. OBTAIN MEDICAL
ATTENTION IN ALL CASES. NOTE TO PHYSICIANS: WHEN ADMINISTED
PARENTERALLY, IT IS A HIGHLY TOXIC DRUG W/A LOW THERAPEUTIC INDEX.
(SEE SUPP)

Extinguishing Media:WATER, CO2, FOAM, DRY CHEMICAL.
Fire Fighting Procedures:WEAR SCBA, FLAME & CHEMICAL RESISTANT
CLOTHING/BOOTS/GLOVES. EVACUATE PERSONNEL UPWIND DIRECTIONS. REMOVE
UNNEED MATERIAL & COOL W/WATER FROM MAXIMUM DISTANCE.
Unusual Fire/Explosion Hazard:FINE POWDERS ARE CONSIDERED TO BE
COMBUSTIBLE.

Spill Release Procedures:ISOLATE AREA & WEAR SUITABLE PROTECTIVE
CLOTHING. COLLECT MATERIAL W/MOIST PAPER TOWELING TO MINIMIZE DUST
GENERATION. CLEAN AREA W/DETERGENT & WATER. TREAT PRODUCT &
CONTAMINATED MATERIALS AS HAZARDO US & PLACE IN SUITABLE CONTAINER
FOR DISPOSAL.

Handling and Storage Precautions:STORE AT/BELOW 77F.
Other Precautions:AVOID INHALATION, INGESTION, SKIN/EYE CONTACT
W/CRUSHED/BROKEN TABLETS.

Respiratory Protection:WEAR APPROVED DUST RESPIRATORS W/HIGH EFFICIENCY
PARTICULATE FILTERS/CARTRIDGES WHEN HANDLING LARGE QUANTITIES OF
BROKEN/CRUSHED TABLETS IN ABSENCE OF SUITABLE EXHAUST VENTILATION.
Ventilation:BIOLOGICAL SAFETY CABINET SHOULD BE USED FOR PREPARATION OF
THIS DRUG. LOCAL MECHANICAL EXHAUST IS RECOMMENDED.
Protective Gloves:DISPOSABLE LATEX SURGICAL
Eye Protection:CHEMICAL SAFETY GOGGLES
Other Protective Equipment:IMPERVIOUS DISPOSABLE COVERALLS W/CLOSED
FRONT, LONG SLEEVES & ELASTIC CUFFS, BOOTS.
Work Hygienic Practices:REMOVE/LAUNDER CONTAMINATED CLOTHING & SHOES
BEFORE REUSE. WASH HANDS AFTER HANDLING/BEFORE EATING/SMOKING/USING
TOILET.
Supplemental Safety and Health
SOLUBILITY: 40 MG/ML FOR CYCLOPHOSPHAMIDE MONOHYDRATE. HEALTH HAZARDS
CONT'D: THIS DRUG MAY BE HARMFUL TO FETUS. NOTE TO PHYSICIANS
CONT'D: CYCLOPHOSPHAMIDE IS A HUMAN CARCINOGEN/POSSIBLE TERATOGEN &
REPRODUCTIVE TOXIN. THOSE W/HEART FAILURE/IMPAIRED RENAL-LIVER
FUNCTIOIN/RECENT RADIATION/CHEMOTHERAPY AT INCREASED RISK

Melt/Freeze Pt:M.P/F.P Text:105.8-113F
Solubility in Water:(SEE SUPP)
Appearance and Odor:ROUND, BICONVEX & WHITE TABLETS W/BLUE FLECKS
MARKED W/EITHER 25/50 FOR STRENGT

Stability Indicator/Materials to Avoid:YES
STRONG OXIDIZERS.
Stability Condition to Avoid:TEMPS >77F.
Hazardous Decomposition Products:CO, CO2, CHLORIDE, HYDROGEN CHLORIDE,
NITROGEN OXIDES, PHOSPHORUS OXIDES, PHOSPHINE.
Conditions to Avoid Polymerization:TEMPS >120F.

Waste Disposal Methods:SHOULD BE INCINERATED AT AN APPROVED FACILITY
IAW/FEDERAL, STATE, LOCAL & COUNTY REGULATIONS. EPA WASTE NO.:
U058.

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.