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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a dermal sensitization study (OECD 429, GLP) with aduct urea-sulfuric (uronium hydrogen sulphate) in acetone/olive oil (4:1 v/v), young NMRI mices (6 females per dose) were tested using the method of LLNA (IMDS test) at concentrations of 25, 50 and 100% (v/v).

In contrast to the information known on the substance (i.e. no irritation by skin contact in the rabbit, no irritation observed in the acute oral and dermal test) a severe irritant effect of the test item Aduct urea-sulfuric was revealed.

This irritant effect is probably due to the used of a solvent (acetone/olive oil), that promotes penetration of the test item through the skin barrier.

Based on this study and the lack of sensitizing properties of its degradation products (urea and sulfates), Uronium hydrogen sulphate is not considered as a sensitizer to the skin.

Migrated from Short description of key information:
Uronium hydrogen sulphate is considered as not sensitising to the skin, but a non-specific (irritant) effect was observed during the test.

Justification for classification or non-classification

Data are conclusive for skin sensitisation, but not sufficient for classification according to CLP criteria (Regulation (EC) No 1272/2008). No classification is proposed for skin sensitisation according to CLP.