Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Evidence from bacterial mutagenicity studies showed that the test substance is not a bacterial cell mutagen in the absence of metabolic activation, with mixed findings being observed in the presence of metabolic activation. Primarily negative findings were reported for mammalian cell mutagenesis assays in absence of metabolic activation, whereas discrepant findings were reported in the presence of metabolic activation. The test substance did not increase DNA damage or repair in cells in the absence of metabolic activation. Finally, the three in vivo genotoxicity studies were negative.

Short description of key information:
Twenty four in vitro and/or in vivo studies have been performed on the test material to evaluate specific types of genotoxicity, including chromosome aberrations, gene mutations, DNA damage/repair, base-pair substitutions, and frameshift mutations. In the absence of metabolic activation, the available in vitro mammalian cell gene mutation assays and bacterial assays are primarily negative. In the presence of metabolic activation, discrepant findings were reported in a mammalian cell assay, whereas the results in bacterial assays were equivocal for base-pair substitutions and frameshift mutations. The test material was negative for inducing DNA damage/repair in mammalian cell and bacterial assays. No evidence of gentoxicity was found from in vivo studies. Two micronucleus assays and a dominant lethal assay reported negative findings.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The weight of evidence supports that the test substance is not genotoxic. See: Regulation (EC) No 1272/2008; See Official Journal of the European Union, (2008) Vol. L353, pp. 1-1355, at p. 102 (para. 3.5.2.3.9).