Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

A battery of in vitro assays have been conducted with the submission substance or with a read-across substance, which address all relevant genetic toxicity endpoints.

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

Genetic toxicity in vivo

Description of key information

Although not required, a bone marrow rat micronucleus study is also available for the read-across substance, which was conducted as part of the repeated dose study. The study showed no evidence of aneuploidy.

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

Additional information

Justification for classification or non-classification

There is no indication for mutagenicity based on a negative Ames test with the submission substance, negative studies of mammalian cell mutation and mammalian cell clastogenicity with a read-across substance and a negative mouse bone marrow micronucleus assay with the read-across substance. Classification for mutagenicity according to CLP is not required.