Registration Dossier

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
In an OECD 414 Prenatal development study in the rat a dosage of 750 mg/kg bw/day was regarded as a No Observed Adverse Effect Level (NOAEL) for the pregnant female.No statistically significant treatment re

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion