International Agency for Research on Cancer (IARC) - Summaries & Evaluations
VOL.: 26 (1981) (p. 203)
5. Summary of Data Reported and Evaluation
5.1 Experimental data
Dacarbazine is carcinogenic in mice and rats. Following its oral or
intraperitoneal administration to rats, dacarbazine produced tumours
at various sites, including breast, thymus, spleen and brain, in as
little as 18 weeks after initial exposure. After its intraperitoneal
administration to mice, dacarbazine produced tumours at various sites,
including lung, haematopoietic tissue and uterus.
Dacarbazine can induce teratogenic effects in several species. It is
mutagenic in mammalian cells in culture.
5.2 Human data
Dacarbazine has been used since the early 1970s in the treatment of
malignant melanoma and is occasionally used in the therapy of other
neoplastic diseases which have become resistant to alternative
The available data are insufficient to evaluate the teratogenicity,
mutagenicity or chromosomal effects of dacarbazine in humans.
A single case of acute leukaemia following treatment with dacarbazine
in combination with other cytotoxic agents has been reported. The only
epidemiological study was small and of short duration and showed no
excess of subsequent neoplasms in patients treated with a regimen
consisting of dacarbazine, adriamycin, bleomycin and vinblastine.
There is sufficient evidence for the carcinogenicity of dacarbazine
in mice and rats. The data from studies in humans are inadequate to
evaluate the carcinogenicity of dacarbazine.
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