Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because relevant human exposure can be excluded as based on the provided thorough and rigorous exposure assessment

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion