Registration Dossier

Diss Factsheets

Administrative data

short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
No effect was observed based on an acute dermal toxicity study (OECD 402) with a LDO value > 2000 mg/kg. The substance is not irritant to skin and not a skin sensitizer. A dermal penetration study showed a penetration of the substance formulated at 2% at about 2%.
A 28d oral toxicity study is available and corresponds to the worst case scenario in terms of systemic exposure. Moreover, a route to route extrapolation can be made between oral and dermal.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion