Registration Dossier

Administrative data

Description of key information

The substance shall be registered under Article 17 (on-site isolated intermediate); no testing is required; however, an indicative assessment of potential skin sensitizing properties based on non-testing methods is included in this IUCLID.

This indicative assessment of skin sensitizing properties is based on physico-chemical, toxicological, and in silico data. Experimental studies have not been performed for this endpoint.

The substance is of low acute oral toxicity in vivo and is only slightly irritating to rabbit’s skin. In occupational settings no skin effects as skin irritation or skin sensitization were reported. The substance showed no electrophilicity in two Ames tests in vitro.

There are some inconsistent and thus equivocal results for the substance with regard to potential skin sensitization profilers in silico. However, the physico-chemical properties of the substance (solid, very low solubility in water, log Pow >5) do not indicate a relevant dermal absorption potential. There is also no relevant skin irritation potential that would facilitate penetration through the stratum corneum.

In conclusion, the limited available information with special emphasis on the physico-chemical data in this indicative evaluation does not point to a relevant skin sensitization potential in vivo.

Key value for chemical safety assessment

Justification for classification or non-classification

The substance is registered under Article 17 (on-site isolated intermediate); no testing is required; however, an indicative assessment of potential skin sensitizing properties based on non-testing methods is included in this IUCLID.

In conclusion, the limited available information with special emphasis on the physico-chemical data in this indicative evaluation does not point to a relevant skin sensitization potential in vivo.