Registration Dossier
Registration Dossier
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EC number: 207-050-4 | CAS number: 428-59-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In an in vitro clastogenicity study with human lymphocytes, the results were negative with activation and positive without activation. Negative results were observed in an in vitro study in bacterial cells (Salmonella typhimurium), an in vitro study in mammalian cells (Chinese hamster ovary), and an in vivo micronucleus (mouse bone marrow) study. Overall, the test substance is considered negative for genotoxicity.
Short description of key information:
In Vitro (Mutagenic effects - bacterial): OECD 471; Bacterial reverse mutation assay. Negative. Reliability = 1.
In Vitro (Clastogenic effects - mammalian): OECD 473; Chromosome aberrations in human lymphocytes. Negative with activation and positive without activation. Reliability = 1
In Vitro (Mutagenic effects - mammalian): OECD 476; Mammalian Cell Gene Mutation Test (CHO/HGPRT Assay). Negative. Reliability = 1
In Vivo (Clastogenic effects - mammalian): OECD 474; in vivo mouse micronucleus study; Negative at concentrations up to 500 ppm. Reliability = 1.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The test substance did not produce mutagenicity in vitro or clastogenicity when evaluated in vitro and 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 germ-cell mutagenicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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