VOL.: 26 (1981) (p. 217)
5-Fluorouracil can induce embryotoxic and teratogenic effects in several animal species and may be embryolethal in monkeys at doses nontoxic to the mother. The available experimental data on the mutagenicity of 5-fluorouracil are inconclusive; the agent did induce transformation in a mouse cell line.
Data available to the Working Group were insufficient to evaluate the teratogenic potential of this drug in humans. Data on chromosomal aberrations produced by 5-fluorouracil, though limited, suggest that the drug has clastogenic potential.
5-Fluorouracil has been associated in a few case reports with a variety of subsequent neoplasms. In almost all of these cases, the drug was given together with other agents known or suspected of being carcinogens. No epidemiological study was available to the Working Group.
On the basis of the available data, no evaluation could be made of the carcinogenic risk of 5-fluorouracil to humans.
Subsequent evaluation: Suppl. 7 (1987)
See Also: Toxicological Abbreviations Fluorouracil, 5- (IARC Summary & Evaluation, Supplement7, 1987)