Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
A reliable sub-chronic study (90-days) by oral route is already available which can be used for evaluation of systemic toxicity via dermal route by route-to-route extrapolation.
The substance is severly irritating and repeated dose studies by oral route indicated low systemic toxicity. Effects will be characterized by local irritaion effects that are related to duration, quantity and concentration, rather than by systemic toxicity due to dermal uptake. Especially considering that dermal uptake can be expected to be very limited. There are no consumer exposures, only industrial/professional use under circumstances involving the use of PPM following the classification as corrosive. Also in view to limited exposures, animal testing is not required.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion