Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In the Salmonella typhimurium strains TA 98, TA100, TA1535, TA1535 and TA1538 1,3-dichlorobenzene was not mutagenic with or without metabolic activation. Also in the Salmonella typhimurium strains UTH8413 and UTH 8414 1,3-dichlorobenzene showed no evidence of mutagenicity. In the assay with E. coli and Baciullus subtilis rec+ and rec- 1,3-dichlorobenzene was also negative.

In the yeast strain saccharomyces cerevisiae D3 and in the DNA repair assay with E. coli pol A+ and pol A- 1,3-dichlorobenzene revealed a positive result. Because these tests are only reported in the secondary literature and the insufficient reported methods and results combined with the fact that these tests are no standard requirements for the evaluation of mutagenicity, the results are considered as not reliable.

1,3-dichlorobenzene did not induce gene mutations at the HPRT locus in V79 Cells in a GLP guideline study

Two in vitro UDS assay were negative.

A valid in-vivo micronucleus test showed a clear negative result (Mueller 1988).

A rat liver foci bioassay which uses an increased incidence of gamma-glutamyltranspeptidase-positive foci (GGT foci) as an indicator of carcinogenicity was negative.


Justification for selection of genetic toxicity endpoint
Several in-vitro and in-vivo assays are available.

Short description of key information:
Several reverse mutation assays in bacteria and eukaryontes are available or described in the secondary literature. The results of 2 UDS test are available. Additionally an in-vivo chromosome aberration test was conducted and showed a clear negative result.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All available valid tests were negative. Therefore a classification is not justified.