Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The mutagenic potential of the test item was investigated in a bacterial gene mutation test (similar to OECD 471, six tester strains, non GLP) and in the hprt test (OECD 476, GLP). No clastogenic potential was found in the in-vivo micronucleus test performed with a single gavage dose of 5000 mg/kg bw (OECD 474, GLP). The latter study used only 1000 polychromatic erythrocytes per animals for scoring, but a higher number of animals were scored. Overall, all studies are adequate in design and reporting to conclude that the substance has no genotoxic properties.


Short description of key information:
No genotoxic potential was evident in in-vitro as well as in-vivo studies.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There are conclusive and sufficient data for classification of the test item with regard to mutagenicity.

The test item is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008.