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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional information

The study substance was not mutagenic in a range of in vitro and in vivo genotoxicity assays. In a bacterial test, the study substance was not mutagenic in Salmonella strains tested in the presence or absence of metabolic activation. It was also non-cytogenic in an in vitro mammalian cell assay and when tested in an in vivo mouse bone marrow micronucleus assay. Finally, it was not mutagenic in the mouse lymphoma L5178Y/TK+/- cell line, in both the presence and absence of an S9 metabolic system.  All studies were conducted in a manner similar or equivalent to currently established OECD guidelines. All available data indicate the study substance is non-genotoxic.

Short description of key information:

In vitro gene mutation in bacteria, Negative (equivalent or similar to OECD TG 471)

In vitro, gene mutation mammalian-Negative (equivalent or similar to OECD TG 476)

Cytogenicity, 2 key studies-Negative in vitro (OECD 473), Negative in vivo (equivalent or similar to OECD 474)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The negative results in in vitro and in vivo genotoxicity assays do not warrant classification of the study substance as a genotoxin or a clastogen under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.