CAS RN: 107-02-8

Carcinogenicity Evidence

Under the Draft Revised Guidelines for Carcinogen Risk Assessment (U.S. EPA, 1999), the potential carcinogenicity of acrolein cannot be determined because the existing "data are inadequate for an assessment of human carcinogenic potential for either the oral or inhalation route of exposure." There are no adequate human studies of the carcinogenic potential of acrolein. Collectively, experimental studies provide inadequate evidence that acrolein causes cancer in laboratory animals. Specifically, two inhalation bioassays in laboratory animals are inadequate to make a determination because of protocol limitations. Two gavage bioassays failed to show an acrolein-induced tumor response in 2 species of laboratory animals. Suggestive evidence of an extra-thoracic tumorigenic response in a drinking water study in female rats was not supported in the reanalysis of data by an independently-convened pathology working group. Questions were also raised about the accuracy of the reported levels of acrolein in the drinking water from this study. A skin tumor initiation-promotion study was negative, and the findings from an intraperitoneal injection study were of uncertain significance. Although acrolein has been shown to be capable of inducing sister chromatid exchange, DNA cross-linking and mutations under certain conditions, its highly reactive nature and the lack of tumor induction at portals of entry make it unlikely that acrolein reaches systemic sites at biologically-significant exposure levels. The observations of positive mutagenic results in bacterial systems occurred at high concentrations near the lethal dose. This evaluation replaces the cancer assessment for acrolein added to the IRIS database in 1988. Under the Risk Assessment Guidelines of 1986 (EPA/600/8-87/045) applied at that time, acrolein was classified as a possible human carcinogen (Category C). The 1988 classification for acrolein was based on the increased incidence of adrenal cortical adenomas in female rats and carcinogenic potential of an acrolein metabolite, its mutagenicity in bacteria, and its structural relationship to probable or known human carcinogens. The updated cancer characterization considered new study results and reevaluated previous studies.
Evaluation: There is inadequate evidence in humans for the carcinogenicity of acrolein. There is inadequate evidence in experimental animals for the carcinogenicity of acrolein. Overall evaluation: Acrolein is not classifiable as to its carcinogenicity to humans (Group 3).
A4: Not classifiable as a human carcinogen.
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