Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Available studies for mutagenicity, EU Method B13/14, EU Method B10 and Ames test show negative results both with and without metabolic activation.


Justification for selection of genetic toxicity endpoint
Three in-vitro studies available, GLP compliant, same results.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

A non-classification for mutagenicity germ cells is based on the available results according to different in-vitro tests results.