Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Regulation (EC) No 1907/2006, Annex VIII, 8.6 Repeated dose toxicity, column 2: The short-term toxicity study (28 days) does not need to be conducted if a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate species, dosage, solvent and route of administrations were used. A reliable sub-chronic study is available for the oral route. The reliable sub-chronic study for the oral route is used to derive appropriate hazard information for the dermal route by route-to-route extrapolation.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion