International Agency for Research on Cancer (IARC) - Summaries & Evaluations


VOL.: 26 (1981) (p. 79)

5. Summary of Data Reported and Evaluation

5.1 Experimental data

BCNU is carcinogenic in rats, producing tumours of the lung after intraperitoneal or intravenous administration, and intra-abdominal tumours after intraperitoneal administration. Tests in mice by intraperitoneal administration and skin application and in rats by oral administration could not be evaluated.

When tested in mice by skin application together with ultra-violet B irradiation, BCNU caused an earlier appearance of skin tumours.

BCNU is embryo- and fetolethal in rats and rabbits at doses nontoxic to the mother and can induce a variety of severe teratogenic effects in rats.

BCNU is mutagenic in bacteria, Drosophila melanogaster and mammalian cells. It also produces chromosomal aberrations in mammalian cells both in cell culture and in vivo.

5.2 Human data

BCNU has had limited use since the mid-1960s in the treatment of neoplastic diseases.

No data were available to evaluate the teratogenic potential or the mutagenicity or chromosomal effects of BCNU in humans.

BCNU has been associated in case reports with the development of acute nonlymphocytic leukaemia following treatment of primary malignant diseases. In all such cases, BCNU was administered with other anticancer therapies known or suspected of being carcinogenic. No epidemiological study was available.

5.3 Evaluation

There is sufficient evidence for the carcinogenicity of BCNU in rats. The data from studies in humans are inadequate to evaluate the carcinogenicity of BCNU in man.

This chemical should be regarded for practical purposes as if it presented a carcinogenic risk to humans.

For definition of the italicized terms, see Preamble Evaluation.

Subsequent evaluation: Suppl. 7 (1987)

Last updated: 8 April 1998

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       Toxicological Abbreviations