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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

All required in vitro tests showed negative results. According to Column 2 in Annex VIII (Section 8.4), an in vivo test is not necessary given the consistently negative results in multiple in vitro studies.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Information are available from reliable study for all the required in vitro endpoints. The results of all studies were in agreement.

In vitro key studies indicate that the test substance is negative in the gene mutation (bacterial reverse mutation assay / Ames test and in mammalian cell gene mutation test / HPRT), with and without metabolic activation and in the in vitro mammalian micronucleus.

Justification for classification or non-classification

Based on the available data, the test substance does not require classification for mutagenicity according to Regulation (EC) No 1272/2008.