Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Data are not required based on exposure considerations and the availability of repeated dose toxicity data using the oral route of administration, which demonstrate low toxicity.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion