Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)
Justification for type of information:
Section 8.5.3 of Annex VIII further allows for the waiving of acute dermal toxicity testing because the substance does not meet the criteria for classification for acute toxicity by the oral route (Category 5 according to GHS criteria).
Reviews comparing the classification of oral and dermal hazards indicate that it is rare for the dermal test to yield a more severe classification (Thomas and Dewhurst, 2007; Creton et al., 2010; Seidle et al., 2011, Moore et al., 2013).
Under this premise, dermal toxicity of test chemical meeting this criterion should not result in a more severe classification than the corresponding oral hazard and would be classified as a Category 5 dermal hazard.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion