Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

All in vitro tests in genetic toxicity showed negative results. Therefore, there is no need to carry out in vivo studies in genetic toxicity. There is no reason to believe that the negative results would not be relevant to humans.


Justification for selection of genetic toxicity endpoint
No study was selected since all in vitro studies gave negative results.

Short description of key information:
Negative in all tests conducted:
- Ames test with S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 102 (OECD 471 and GLP); tested up to the limit concentration of 5000 µg/plate
- Mammalian cell gene mutation assay with Chinese hamster lung fibroblasts (V79) (OECD 476 and GLP); tested up to the limit concentration of 10 mM
- In vitro micronucleus assay with Chinese hamster lung fibroblasts (V79) (OECD 487 and GLP); tested up to the limit concentration of 5000 µg/mL

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data and in accordance with Regulation (EC) 1272/2008 no classification is needed for mutagenicity.