For definition of Groups, see Preamble Evaluation.
VOL.: 50 (1990) (p. 195)
Chem. Abstr. Name: Hydrazinecarboxamide, 2-[(5-nitro-2-furanyl)methylene]-
Nitrofural is an antibacterial agent used since 1945 mainly for the local treatment of skin infections. It has been used orally in the treatment of refractory African trypanosomiasis.
Nitrofural was tested by oral administration in one study in mice and in two studies in rats, and by transplacental administration to mice. Oral administration to mice increased the incidence of granulosa-cell and benign mixed tumours of the ovary. In rats, an increased incidence of mammary fibroadenomas was observed in females in both studies. Two studies of transplacental administration of nitrofural to mice were inadequate for evaluation.
In a hypothesis-generating cohort study, use of nitrofural was not associated with an increase in cancer incidence, but the power of the study was low.
One study did not provide evidence that topical use of nitrofural during pregnancy is associated with birth defects. Nitrofural is gonadotoxic in male and female mice and in male rats and is teratogenic in mice.
In humans, nitrofural is poorly absorbed from skin and mucous membranes after local administration. The drug binds to liver protein and DNA as well as to kidney protein in rats treated in vivo.
Nitrofural did not induce chromosomal aberrations in rats, micronuclei in mice or rats or sperm abnormalities in mice. It induced sister chromatid exchange in Chinese hamster cells in vitro; contradictory results were obtained on the induction of chromosomal aberrations in mammalian cells. Nitrofural induced DNA strand breaks in human, hamster and mouse cells but did not induce unscheduled DNA synthesis in human, rat or mouse cells. Both positive and negative results were obtained in gene mutation assays in rodent cells. Nitrofural did not induce sex-linked recessive lethal mutations in Drosophila. It was mutagenic to Neurospora but not to Aspergillus and induced differential toxicity in Escherichia coli and Bacillus subtilis and mutations in E. coli and Salmonella typhimurium.
There is inadequate evidence for the carcinogenicity of nitrofural in humans.
There is limited evidence for the carcinogenicity of nitrofural in experimental animals.
Nitrofural is not classifiable as to its carcinogenicity to humans (Group 3).
For definition of the italicized terms, see Preamble Evaluation.
Previous evaluations: Vol. 7 (1974) (p. 171); Suppl. 7 (1987) (p. 67)
Last updated: 11 November 1997
See Also: Toxicological Abbreviations Nitrofural (Nitrofurazone) (WHO Food Additives Series 31)