Registration Dossier

Administrative data

Endpoint:
acute 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
In accordance with Annex VIII, Section 8.5.3, Column 2 of REACH, testing by the dermal route does not need to be conducted if:
- the substance does not meet the criteria for classification as acutely toxic or STOT SE by the oral route and
- no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, 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)
For this substance, no systemic effects were observed in the in vivo acute oral toxicity study (OECD 420), or in the LLNA study (OECD 429) where 100 % (w/w) solution was tested at the highest dose level.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion