Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Justification for selection of genetic toxicity endpoint
No study was selected, since all in vitro genotoxicity studies showed no genotoxic effects.

Short description of key information:
Under the present test conditions the test item tested up to cytotoxic concentrations in the in vitro bacterial mutagenicity assay (Salmonella reverse mutation Assay), the in vitro mammalian mutagenicity assay (Mouse lymphoma Assay) and the in vitro mammalian cytogenetic assay (Micronucleus Test) each assay carried out without and with metabolic activation, revealed no genotoxic activity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Because all in vitro genotoxicity studies revealed clearly negative results, it can be conluded that the test item is not genotoxic in vitro and therefore must not be classifed according to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008.