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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

in vitro studies:

In studies using five Salmonella typhimurium and two Escherichia coli strains, the source substance in concentrations ranging from 15-3000 μg/plate, with and without metabolic activation, did not show mutagenic effects.

There was also no evidence of a mutagenic potential of the source substance in a test for gene mutations in somatic mammalian V79 cells, using concentrations from 9-90 μg/mL, in a V79 chromosome aberration test at concentrations from 1-20 μg/mL, and in a sister chromatid exchange test at concentrations from 0.5-12 μg/mL.

in vivo studies:

In a micronucleus test in mice up to 2700 mg/kg, a chromosome aberration assay in Chinese hamsters up to 5000 mg/kg and a DNA repair test in rats up to 500 mg/kg/day, the oral administration of the source substance did not show evidence of genotoxic or clastogenic effects.

Short description of key information:
The potential mutagenic/genotoxic effects of the source substance were evaluated in a battery of in vitro and in vivo tests. No test did show evidence of genotoxic or clastogenic effects. The data can be applied to the target substance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According the classification criteria described in REGULATION (EC) No 1272/2008 (CLP), the substance has not to be classified as mutagenic / genotoxic.