5-Fluorouracil Safety Data Sheets

Acute toxicity - Category 3, Oral

Acute toxicity - Category 4, Dermal

Skin irritation, Category 2

Eye irritation, Category 2

Specific target organ toxicity – single exposure, Category 3

Germ cell mutagenicity, Category 1B

Reproductive toxicity, Category 1B

If inhaled

Following skin contact

Following eye contact

Following ingestion

Minimum toxic dose in humans is approximately 450 mg/kg (total dose) over 30 days for the ingested drug. Intravenous minimum toxic dose in humans is a total dose of 6 mg/kg over three days. Depression of white blood cells occurred after intravenous administrative of a total dose of 480 mg/kg over 32 days. Occasional neuropathy and cardiac toxicity have been reported. Do not use during pregnancy. Patients with impaired hepatic or renal function, with a history of high-dose pelvic irradiation or previous use of alkylating agents should be treated with extreme caution. Patients with nutritional deficiencies and protein depletion have a reduced tolerance to fluorouracil. (EPA, 1998)

Emits very toxic fumes of flourides and nitrogen oxides when heated to decomposition. Avoid decomposing heat. (EPA, 1998)

Wear self-contained breathing apparatus for firefighting if necessary.

Avoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable gloves. Ensure adequate ventilation.Remove all sources of ignition. Evacuate personnel to safe areas.Keep people away from and upwind of spill/leak.

Prevent further spillage or leakage if it is safe to do so. Do not let the chemical enter drains. Discharge into the environment must be avoided.

PRECAUTIONS FOR ANTINEOPLASTIC AGENTS:/ Spill kits containing all materials needed to clean up spills of hazardous drugs should be assembled or purchased. These kits should be readily available in all areas where hazardous drugs are routinely handled. If hazardous drugs are being prepared or administered in a nonroutine area (home setting or unusual patient-care area), a spill kit should be obtained by the drug handler. The kit should include two pairs of disposable gloves (one outer pair of utility gloves and one inner latex pair); low-permeability, disposable protective garments (coveralls or gown and shoe covers); safety glasses or splash goggles; respirator; absorbent, plastic-backed sheets or spill pads; disposable toweling; at least 2 sealable thick plastic hazardous waste disposal bags (prelabeled with an appropriate warning label); a disposable scoop for collecting glass fragments; and a puncture-resistant container for glass fragments. All individuals who routinely handle hazardous drugs must be trained in proper spill management and cleanup procedures. Spills and breakages must be cleaned up immediately according to the following procedures. If the spill is not located in a confined space, the spill area should be identified and other people should be prevented from approaching and spreading the contamination. Wearing protective apparel from the spill kit, workers should remove any broken glass fragments and place them in the puncture-resistant container. Liquids should be absorbed with a spill pad; powder should be removed with damp disposable gauze pads or soft toweling. The hazardous material should be completely removed and the area rinsed with water and then cleaned with detergent. The spill cleanup should proceed progressively from areas of lesser to greater contamination. The detergent should be thoroughly rinsed and removed. All contaminated materials should be placed in the disposal bags provided and sealed and transported to a designated containment receptacle. Spills occurring in the biohazard cabinet should be cleaned up immediately; a spill kit should be used if the volume exceeds 150 ml or the contents of one drug vial or ampule. If there is broken glass, utility gloves should be worn to remove it and place it in the puncture-resistant container located in the biohazard cabinet. The biological safety cabinet, including the drain spillage trough, should be thoroughly cleaned. If the spill is not easily and thoroughly contained, the biological safety cabinet should be decontaminated after cleanup. If the spill contaminates the high efficiency particulate air filter, use of the biological safety cabinet should be suspended until the cabinet has been decontaminated and the high efficiency particulate air filter replaced. Antineoplastic agents

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.

Store at 25 deg C (77 deg F); excursions permitted to 15 deg C - 30 deg C (59 deg F -86 deg F). Efudex Solutions

Occupational Exposure limit values

Biological limit values

Eye/face protection

Skin protection

Respiratory protection

Thermal hazards

no data available

Stable when exposed to air.

FLUOROURACIL may be sensitive to prolonged exposure to light. Solutions discolor on storage. This chemical can react with oxidizing agents and strong bases. Incompatible with methotrexate sodium. (NTP, 1992)

no data available

Oxidizers, strong bases, heat.

When heated to decomposition it emits very toxic fumes of /hydrogen fluoride and nitrogen oxides/.

Acute toxicity

• Oral: LD50 Dog oral 30 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: EC50; Species: Pimephales promelas (Fathead minnow); Conditions: fresh water; static, temperature 24 deg C; Concentration: 400000 ug/L (95% confidence limit: 170000 to 910000 ug/L) for 5 days Effect: growth; abnormal /formulated product
• Toxicity to daphnia and other aquatic invertebrates: no data available
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

AEROBIC: Fluorouracil, present at 5 mg/L, was shown to biodegrade 100% within 5 days using an activated sludge inoculum and the OECD confirmatory test, detection limit = 0.2 mg/L(1). The initial rate was dependent on initial concentration: the higher concentration, the slower the degradation. 100% biodegradation in 14 days was observed when presented as a mixture with other cytostatic compounds(1).

An estimated BCF of 3 was calculated in fish for fluorouracil(SRC), using a log Kow of -0.89(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 fluorouracil is estimated as 8(SRC), using a log Kow of -0.89(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that fluorouracil is expected to have very 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/