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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The mutagenic potential of the substance was evaluated according to the OECD Guideline 471 and according to the method found in Ames, B.N et al. (1975), Gatehouse, D. (1994), Maron, D.M. and Ames, B.N. (1983). The substance was tested in 5 different concentrations ranging from 0.06 to 5 μg/plate in the plate incorporation test with and without metabolic activation (S9 mix). Two plates per dose per strain were incubated for 48 hours at 37 °C, after which the revertant colonies were evaluated for the test plates, negative and positive controls. Cytotoxicity was observed at the highest concentrations of TA 1537, TA100 and TA98 without metabolic activation and at the highest concentration at TA1537, TA1535 and TA98 with metabolic activation.

The substance did not show any evidence of mutagenicity under the test conditions.

Justification for classification or non-classification

The substance did not show any evidence of mutagenicity in the in vitro gene mutation study in bacteria cells. It is, therefore, not classified for mutagenicity according to the CLP Regulation (EC) No. 1272/2008.