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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Justification for type of information:
According to Moore & al. (2013), oral administration represents a worst-case scenario compared to dermal administration, and a substance with a LD50 (oral) >2000 mg/kg is not expected to be classified for acute systemic toxicity by the dermal route. Moreover, in accordance with Annex VIII of REACH, Column 2, assessing the acute toxicity by dermal route is relevant only if the inhalation of the substance is unlikely, and if the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin, which is not the case for the registered substance as the substance is a solid generating dust when handle.

In addition due to the particle size of the substance, it cannot be absorbed as such following a dermal exposure. It must first be dissolved for the absorption process to occur. However, the high lattice energy of the structure implies that it would require conditions far more extreme than those the substance will experience on the skin. Therefore no dissolution is expected following a dermal exposure, and no absorption will occur.

Moore NP, Andrew DJ, Bjerke DL, Creton S, Dreher D, Holmes T, Prieto P, Seidle T, Rowan TG (2013) Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Regul Toxicol Pharmacol. 2013 Jun;66(1):30-7

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion