Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Justification for type of information:
A screening study for reproductive/developmental toxicity (OECD 421 or 422) does not need to be conducted if a prenatal developmental toxicity study is available. As a prenatal developmental toxicity study is available, the criteria for adaptation are met.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion