Registration Dossier

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro gene mutation study in mammalian cells does not need to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion