Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Each in-vitro study presented are GLP compliant and scored Klimisch 1 for reliability. The results are consistent among the three sets of studies for each mutation tested. No hazardous fragments have been found to be of structural alert.


Justification for selection of genetic toxicity endpoint
There are three in vitro studies for bacterial reverse gene mutation, three for mammalian cell gene mutation and three for mammalian chromosome aberration test. All three studies give negative results.

Short description of key information:
Each in-vitro study is clearly negative - both with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008.

The results have been compared to the criteria set up in the Annex I of the Regulation (section 3.5). As a result the substance is not considered to be classified for genotoxicity under Regulation (EC) No. 1272/2008.