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:
In view of the absence of effects to reproductive organs in a 90 day study on this substance and in view of the absence of effects in development studies, further animal work cannot be justifed.
Cross-reference
Reason / purpose:
data waiving: supporting information

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion