Cyclophosphamide Safety Data Sheets

Acute toxicity - Category 3, Oral

Germ cell mutagenicity, Category 1B

Carcinogenicity, Category 1B

Reproductive toxicity, Category 1A

If inhaled

Following skin contact

Following eye contact

Following ingestion

SYMPTOMS: Symptoms of exposure to this compound may include nausea, vomiting, leukopenia, thrombocytopenia, alopecia and anorexia. Other symptoms may include pigmentation of the skin, oral mucosal ulcerations and sterile hemorrhagic cystitis. It can cause non-specific dermatitis, pigmentation of the nails, regrowth of hair, anemia, hematuria, fibrosis of the ovaries, gonadal suppression resulting in amenorrhea or azoospermia, hemorrhagic colitis and jaundice. It can also cause damage to the hair follicles, dizziness of short duration, transverse ridging of the nails and hepatic toxicity. Secondary neoplasia and nephrotoxicity have been reported. Other symptoms may include irritation of the skin, gastrointestinal disturbances and hepatic dysfunction. High doses over a prolonged period can cause interstitial pulmonary fibrosis. Other symptoms of exposure may include granulocytopenia, myocardial damage, interstitial pneumonia and hypoplasia of all elements of bone marrow. It has been known to cause blurred vision, pulmonary fibrosis, cardiomyopathy and sterility. Fetal abnormalities can occur if ingested while pregnant. Eye contact can cause transient blurring of vision, dry eye syndrome, viral and other keratitis and severe keratoconjunctivitis associated with graft-versus-host disease leading to scarring of the corneas. It may also cause lymphocytopenia. ACUTE/CHRONIC HAZARDS: This compound is a skin irritant. When heated to decomposition it emits highly toxic fumes of POx, NOx and chloride ion. (NTP, 1992)

Flash point data for this chemical are not available; however, it is probably combustible. (NTP, 1992)

Use water spray, powder, foam, carbon dioxide.

Personal protection: particulate filter respirator adapted to the airborne concentration of the substance. Sweep spilled substance into covered sealable containers. If appropriate, moisten first to prevent dusting. Carefully collect remainder. Then store and dispose of according to local regulations.

Consult an expert! Personal protection: particulate filter respirator adapted to the airborne concentration of the substance. Sweep spilled substance into covered sealable containers. If appropriate, moisten first to prevent dusting. Carefully collect remainder. Then store and dispose of according to local regulations.

PRECAUTIONS FOR "CARCINOGENS": A high efficiency particulate arrestor (HEPA) or charcoal filters can be used to minimize amt of carcinogen in exhausted air ventilated safety cabinets, lab hoods, glove boxes or animal rooms ... Filter housing that is designed so that used filters can be transferred into plastic bag without contaminating maintenance staff is available commercially. Filters should be placed in plastic bags immediately after removal ... The plastic bag should be sealed immediately ... The sealed bag should be labelled properly ... Waste liquids ... should be placed or collected in proper containers for disposal. The lid should be secured & the bottles properly labelled. Once filled, bottles should be placed in plastic bag, so that outer surface ... is not contaminated ... The plastic bag should also be sealed & labelled. ... Broken glassware ... should be decontaminated by solvent extraction, by chemical destruction, or in specially designed incinerators. Chemical Carcinogens

NO open flames. Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.

Separated from food and feedstuffs. See Chemical Dangers. Dry. Keep in the dark. Well closed.Cyclophosphamide should be preserved in tight containers, at a temperature between 2 & 32 deg C.

Occupational Exposure limit values

Biological limit values

Eye/face protection

Skin protection

Respiratory protection

Thermal hazards

Decomposes on burning. This produces toxic fumes including phosphorus oxides and nitrogen oxides.

Aq soln keeps for a few hr @ room temp, but hydrolysis occurs above 30 deg c, removes chlorine atoms; darkens on exposure to light monohydrate

CYCLOPHOSPHAMIDE is sensitive to exposure to light (darkens). Also sensitive to oxidation. Aqueous solutions may be kept for a few hours at room temperature, but hydrolysis occurs at temperatures above 86°F. Solutions in DMSO, 95% ethanol or acetone are stable for 24 hours under normal lab conditions. Incompatible with benzyl alcohol. Undergoes both acid and base hydrolysis at extreme pHs (NTP, 1992)

no data available

It was/ reported that immersion of a needle with an aluminum component in cyclophosphamide 20 mg/ml resulted in a slight darkening of the aluminum & gas production after a few days at 24 deg C with protection from light.

When heated to decomposition it emits highly toxic fumes of /phosphorus oxides, nitrogen oxides, & hydrogen chloride/.

Acute toxicity

• Oral: LD50 Rat oral 160 mg/kg
• Inhalation: no data available
• Dermal: no data available

Skin corrosion/irritation

Serious eye damage/irritation

Respiratory or skin sensitization

Germ cell mutagenicity

Carcinogenicity

Reproductive toxicity

STOT-single exposure

STOT-repeated exposure

Aspiration hazard

• Toxicity to fish: no data available
• Toxicity to daphnia and other aquatic invertebrates: no data available
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

AEROBIC: Cyclophosphamide has been shown to be non-biodegradable in a laboratory-scale sewage treatment studies(1-3). During 29 days of 10 ug/l compound addition, a mean effluent recovery of 83% was established(2). Cyclophosphamide, present at 160 mg/l, indicated no DOC elimination in four weeks using an activated sludge inoculum at 0.2 g/l and the Zahn-Wellens test(2). The compound is confirmed to be non-biodegradable according to the OECD confirmatory test using both single compound and compound mixtures run from a period of 10-14 days at concentrations ranging from 150 to 750 mg/l and that employs a sewage sludge inoculum(3).

An estimated BCF of 3 was calculated for cyclophosphamide(SRC), using a log Kow of 0.63(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC).

The Koc of cyclophosphamide is estimated as 52(SRC), using a log Kow of 0.63(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that cyclophosphamide is expected to have high mobility in soil.

no data available

Product

Contaminated packaging

no data available

no data available

Information on revision

Abbreviations and acronyms

• CAS: Chemical Abstracts Service
• ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
• RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
• IMDG: International Maritime Dangerous Goods
• IATA: International Air Transportation Association
• TWA: Time Weighted Average
• STEL: Short term exposure limit
• LC50: Lethal Concentration 50%
• LD50: Lethal Dose 50%
• EC50: Effective Concentration 50%

References

• IPCS - The International Chemical Safety Cards (ICSC), website: http://www.ilo.org/dyn/icsc/showcard.home
• HSDB - Hazardous Substances Data Bank, website: https://toxnet.nlm.nih.gov/newtoxnet/hsdb.htm
• IARC - International Agency for Research on Cancer, website: http://www.iarc.fr/
• eChemPortal - The Global Portal to Information on Chemical Substances by OECD, website: http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en
• CAMEO Chemicals, website: http://cameochemicals.noaa.gov/search/simple
• ChemIDplus, website: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
• ERG - Emergency Response Guidebook by U.S. Department of Transportation, website: http://www.phmsa.dot.gov/hazmat/library/erg
• Germany GESTIS-database on hazard substance, website: http://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp
• ECHA - European Chemicals Agency, website: https://echa.europa.eu/

Other Information

CAS No. for monohydrate is 6055-19-2.Depending on the degree of exposure, periodic medical examination is suggested.Do NOT take working clothes home.