Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Mutagenic effects - bacterial: OECD 471; Ames study. Negative. Reliability = 1.

Clastogenic effects - mammalian: OECD 473; Chromosome aberrations in human peripheral blood lymphocytes. Negative. Reliability = 1.

Mutagenic effects - mammalian: EU Method B.1, in vitro mammalian cell gene mutation test. Negative. Reliability = 1.

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

Genetic toxicity in vivo

Description of key information

In vivo (Chromosome aberration – mammalian): OECD 474; Mouse Micronucleus assay. Negative. Reliability = 1

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

Additional information

Under in vitro conditions, the substance was not found to be mutagenic in bacterial cells and was not clastogenic in human peripheral blood lymphocytes. The substance was negative in an in vitro mammalian cell gene mutation test and negative in an in vivo mouse micronucleus assay. Based on the results of this battery of in vitro and in vivo studies, it is concluded that the substance is not genotoxic in cell culture or laboratory animals.

Justification for classification or non-classification

The test substance did not produce mutagenicity or clastogenicity in vitro in bacterial or mammalian cells or when evaluated in vivo in laboratory animals. Therefore, the substance does not need to be classified for mutagenicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.