Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

An excellent package of GLP experimental studies have been performed to cover the mutagenicity potential in bacteria and mammalian cells “in vitro” as well as “in vivo” approach. All studies were performed both with metabolic activation and without metabolic activation in order to check if any metabolic process can activate or enhance the mutagenic effects, if any.

Results from in vitro genotoxicity tests (bacterial, fungal, mammalian systems; with and without

metabolic activation) are mixed, with both positive and negative studies, indicating that 1,2-dichloropropane may have in vitro mutagenic potential. However, results from two last in vivo studies demonstrate that 1,2-dichloropropane was not active in an mouse micronucleus test or a rat dominant lethal assay. These findings indicate that 1,2-dichloropropane is not an in vivo somatic or germ cell genotoxicant, despite widespread distribution throughout the body. In addition, results from adequate carcinogenicity assays (see discussion on section 5.8) in rats and mice provide supplementary information on the mutagenic potential of 1,2-dichloropropane in vivo. The findings (limited to liver tumors in mice and no convincing evidence of carcinogenicity in the rat) indicate that the compound is not a genotoxic carcinogen.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the reported studies and taking into account the literature, 1,2-dichloropropane does not meet the classification criteria as genotoxic.