Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
No evidence for genetic toxicity was found in the bacterial reverse mutation test, mammalian cell reverese mutation test and micronucleus test. Clearly negative in vitro studies - both with and without metabolic acitvation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The three performed studies were GLP compliant and of high quality (Klimisch score = 1). Therefore, there is no reason to believe that these results would not be applicable to humans.


Justification for selection of genetic toxicity endpoint
well performed study according to OECD Guidelines

Justification for classification or non-classification

No adverse effects were observed.