Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Justification for type of information:
According to OECD Series on Testing and Assessment No 237, reviews comparing the classification of oral and dermal hazards indicate that it is rare for the dermal test to yield a more severe classification. under this premise, substance would be classified in the corresponding GHS category as the oral hazard, if the LD50 oral is less than 300 mg/kg bw.

However, for substances where the oral LD50 range is between 300 and 2000 mg/kg and dermal penetration data indicates low dermal absorption (<10%) relative to oral absorption, the LD50 would equate to a dermal-equivalent value of 3000 mg/kg bw. However, this approach, which is assuming a high oral bioavailability, must be reconsidered if available information indicates low oral bioavailability of the substance.
Although the LD50 of the substance by oral route is between 300 and 2000 mg/kg, the toxicokinetic of the substance is not compliant with the above assumptions. Therefore, as a reasonable worst case scenario, and taking into account animal welfare consideration, the substance will be classified for dermal toxicity in the corresponding GHS category as the oral hazard, i.e. category 4, in the same way as the oral hazard was less than 300 mg/kg.
This is supported by the fact that in a sensitization test performed on the very closed analogue, no systemic toxicity was observed throughout the study on mice.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion