Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A bacterial mutagenicity test, performed according to OECD guideline 471 (RL1) is available, showing no mutagenic activity. This is supported by several less reliable studies (RL2) with the same results in bacteria and also in yeast.

Also, no mutagenic response was observed in mammalian cells in vitro (HPRT-test, RL1).

One reliable in vivo study is available (RL2), which examined the induction of micronuclei after oral exposure to mice. Based on these consistent negative results, no further testing is required.


Short description of key information:
No mutagenic effects were observed in any of the available in vitro studies in bacteria and mammalian cells, supported by Ames-tests from less reliable studies. One reliable in vivo study did not observe the induction of micronuclei in mice.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the findings of reliable studies in vitro and in vivo, the test substance has not to be classified for genotoxic effects according to Regulation (EC) No 1272/2008.