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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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 no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Justification for type of information:
In an acute oral toxicity study with ICR mice the dosing with up to 3000 mg/kg bw caused no adverse effects, i.e. the oral LD50 value of the test item is > 3000 mg/kg bw. A Draize test comparable to OECD Guideline 404 gave no indication for adverse systemic effects and there was also no indication for a skin irritating potential of the test item. Also in a GPMT comparable to OECD Guideline 406 the test item caused no adverse effects and gave no indication for a skin sensitisation potential.
Therefore, due to animal welfare reasons, further experimental testing with dermal exposure at present is scientifically not justified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion