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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test substance did not induce mutagenicity in this reverse mutation assay, in the absence and presence of metabolic activation.

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

Additional information

The potential genotoxicity of the test substance was assessed in an Ames test performed in accordance with OECD Guideline 471 and following GLP. The test strains included S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA and tests were performed in the presence and absence of a metabolic activation system (rat liver S-9). The study included a standard plate test as well as a pre-incubation test. In both tests, the doses used were 33, 100, 333, 1000, 2500, and 5000 µg/plate. DMSO was selected as the vehicle. No precipitation of the test substance was found. A bacteriotoxic effect was observed depending on the strain and test conditions from about 2500 μg/plate onward. A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Under the experimental conditions chosen here, it is concluded that the test substance is not a mutagenic agent in a bacterial reverse mutation test.

Justification for classification or non-classification

Based on the available information the test substance does not need to be classified for genetic toxicity in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.