Registration Dossier

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:

For the registered substance, one reliable (Klimisch 1) skin sensitisation study (LLNA) was available.

A LLNA/IMDS was carried out in female NMRI mice after epicutaneous application of a formulation containing 0, 2, 10 or 50% of the registered substance for 3 consecutive days onto both ears of the animals. This study did neither point to a non-specific (irritating) nor to a specific immunostimulating (sensitizing) potential of the substance. This applies to NMRI mice, for weight and cell counts of the draining lymph nodes as well as ear swelling and ear weight indices evaluated after application. In summary, no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 50% of the registered substance by the method used. Therefore, the concentration of 50% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization (Bayer, 2006).

These results are supported by a repeated human insult patch test, which was completed by 110 participants. In this study the registered substance did not indicate a clinically significant potential for allergic contact sensitization (see IUCLID section 7.10.4). (CPT, 2007)


Migrated from Short description of key information:
In a GLP-study according to OECD test guideline 429 (LLNA), the registered substance did not induce any skin sensitisation. A repeated human patch insult test with volunteers did not indicate a clinically significant potential for allergic contact sensitization (see IUCLID section 7.10.4).

Justification for classification or non-classification

Based on the results of the skin sensitization studies, the test item is not subjected to classification according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS,CLP).

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