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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Non mutagenic with and without metabolic activation (Ames test)

Non mutagenic with and without metabolic activation (Chromosome aberration test)

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The genotoxicity potential of the test substance was evaluated in vitro in a bacterial reverse mutation assay and in a chromosome aberration study in human lymphocytes. The Ames study was performed with and without metabolic activation on the S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100 strains at concentrations in the range 50 - 5000 μg/plate. The chromosome aberration study was performed at concentrations in the range 78.1-480 μg/ml with metabolic activation and 20-156.25 μg/ml without metabolic activation.

In both studies, the substance was found as non-mutagenic with and without metabolic activation.

Justification for classification or non-classification

The substance did not induce genetic toxicity both in the Ames study and in the chromosome aberration study. Therefore, the substance is not classified for mutagenicity according to the CLP Regulation (EC) No.1272/2008.