Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In Vitro (Mutagenic effects - bacterial): OECD 471; Bacterial reverse mutation assay. Negative. Reliability = 1.

In Vitro (Clastogenic effects - mammalian): OECD 487; Micronucleus in human lymphocytes. Negative. Reliability = 1.

In Vitro (Mutagenic effects - mammalian): OECD 476; Mammalian Cell Forward Gene Mutation (CHO/HPRT). Negative. Reliability = 1.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Negative results were observed for in vitro studies in bacterial cells (Salmonella typhimurium and E. coli) and mammalian cells (CHO/HPRT), and in vitro studies for clastogenic effects (human lymphocytes). Therefore, overall, the test substance is considered negative for genotoxicity.

Justification for classification or non-classification

Overall, the test substance did not produce mutagenicity or clastogenicity when evaluated in in vitro bacterial and mammalian cells. 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 EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.