Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The test substance did not produce mutagenicity when evaluated in cell culture or laboratory animals.


Short description of key information:
In Vitro (Mutagenic effects - bacterial): OECD 471; Ames study. Not mutagenic. Not classified as a mutagen. Reliability = 1.
In Vitro (Mutagenic effects - mammalian): OECD 476; Mouse lymphoma assay. Not mutagenic. Not classified as a mutagen. Reliability = 1
In Vivo (Clastogenic effects - mammalian): OECD 474; in vivo rat micronucleus study; Not mutagenic at concentrations up to 72179 mg/m3. Clinical signs of toxicity (central nervous system) were observed at concentrations of 20618 mg/m3 and higher. Not classified as a mutagen. Reliability = 1.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance did not produce mutagenicity when evaluated in cell culture or laboratory animals. The substance does not need to be classified for mutagenicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.