Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

All three 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
Conclusion based on the following assays: Bacterial reverse mutation assay (Ames test); Mammalian cell gene mutation assay; In vitro mammalian chromosome aberration test

Short description of key information:
Negative in all tests conducted:
- Ames test (OECD TG 471 and GLP); no toxicity was observed up to a concentration of 5000 µg/plate.
- Mammalian cell gene mutation assay (OECD Guideline 476 and GLP); cytotoxicity: preliminary toxicity tests
- In vitro mammalian chromosome aberration test (OECD Guideline 473 and GLP); cytotoxicity: no

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification