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Key value for chemical safety assessment

Additional information

Although positive results were observed in one in vitro clastogenicity study with CHO cells, negative results were observed for in vitro studies in bacterial cells (Salmonella typhimurium and E. coli) and mammalian cells (mouse lymphoma cells). In vivo studies yielded negative results for chromosome aberrations (mouse bone marrow), micronucleus (mouse bone marrow), and UDS (rat liver cells). Therefore, overall, the test substance is considered negative for genotoxicity.


Short description of key information:
In Vitro (Mutagenic effects - bacterial): OECD 471; Ames study. Negative. Reliability = 1..
In Vitro (Mutagenic effects – mammalian): OECD 476; Mouse lymphoma study. Negative. Reliability = 1
In Vitro (Clastogenic effects - mammalian): OECD 473; Chromosome aberrations in CHO cells. Positive. Reliability = 1
In Vivo (Clastogenic effects - mammalian): OECD 474; in vivo mouse micronucleus study; Negative at doses up to 1300 mg/kg. Reliability = 1.
In Vivo (Clastogenic effects - mammalian): OECD 475; in vivo mouse bone marrow chromosome aberration study; Negative at doses up to 1300 mg/kg. Reliability = 1
In Vivo (Clastogenic effects - mammalian): OECD 486; in vivo rat UDS study; Negative at doses up to 2000 mg/kg. Reliability = 1

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance did not produce mutagenicity or clastogenicity when evaluated in laboratory animals. Based on an assessment of the robust genetic toxicity data for this substance, the substance does not need to be classified for mutagenicity according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.