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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Justification for type of information:
The acute dermal toxicity of the test substance was determined with doses of 17,800 and 21,500 mg/kg b.w. The skin reaction was checked independently by two investigators with regard to development of erythema as well as edema. No intolerance reactions (no erythema and no edema) were observed up to the highest testing dose.

- no local skin reactions and no specific clinical symptoms were evident in the dose groups applied
- no specific pathological findings were evident on macroscopical examination at the end of the post-observation period (number and kind of organs not specified)
- no changes in body weight development and food intake was observable
- LD50 was estimated to be > 21500 mg/kg b.w. (males and females)

The study design followed provisions of OECD guideline 402.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion