Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

No evidence for the induction of reverse mutation was observed in an Ames test (BASF SE, 2011) performed in S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and in E. coli strain WP2 uvrA. No evidence for the induction of reverse mutation was observed in a second Ames test (Anonymous) performed inS. typhimuriumstrains TA 98, TA 100, TA 1535 and TA 1537. In both studies, the substance was tested up to the limit concentration in the absence and presence of metabolic activation.

No evidence for the induction of forward mutation was seen in a study (BASF SE, 2012) performed in cultured CHO cells at concentrations up to 1700 µg/mL and in the absence and presence of metabolic activation.

No evidence for the induction of micronuclei formation was observed in a study performed in V79 cells at concentrations up to 1700 µg/mL and in the absence and presence of metabolic activation.


Justification for selection of genetic toxicity endpoint
No key study: a weight of evidence approach is taken for this endpoint

Short description of key information:
Studies of bacterial reverse mutation (Ames test), mammalian cell mutation and mammalian cell cytogenicity in vitro are available for the substance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There is no evidence for genetic toxicity; no classification for genetic toxicity is therefore proposed according to the CLP Regulation (Regulation (EC) No. 1272/2008) or the Dangerous Substances Directive (Directive 67/548/EEC).