Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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 physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Justification for type of information:
According to REACH Annex VIII, 8.5.3. Column 2, testing by the dermal route is appropriate if inhalation of the substance is unlikely; and skin contact in production and/or use is likely; and the physiochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. Testing by the dermal route does not need to be conducted if: the substance does not meet the criteria for classification as acute toxicity 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). The substance does not meet criteria for classification as acutely toxic by the oral route (LD50 > 2500 mg/kg bw/d) and there were no signs of systemic toxicity or abnormalities at necropsy. A local lymph node assay found the substance to cause no systemic effects and in vitro skin irritation and skin corrosion studies predicted the substance to be non-irritant and non-corrosive. Therefore, toxicity by the dermal route is considered unlikely and a study was not conducted via this route

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion