Registration Dossier

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.