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Description of key information

not skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

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

In order to assess the skin sensitisation potential of the test material an in vivo test to guinea pigs was performed according to the OECD Guideline 406 (1981).

Based on the results of the sighting studies, the concentrations of test material for the induction and challenge phases were selected  as follows:

Intradermal Induction: 5% (w/v) in distilled water

Topical Induction: 75% (w/w) in distilled water

Topical Challenge: 25% (w/w) in distilled water

The test material produced a 0% (0/20) sensitisation rate and was considered as a non-sensitiser to guinea pig skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the CLP Regulation (EC) no. 1272/2008, in the section 3.4 Respiratory or skin sensitisation, a skin sensitizer is defined as a substance that will lead to an allergic response following skin contact.

A substance shall be classified as skin sensitisers (Category 1) where data are not sufficient for subcategorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test (according to 3.4.2.2.4.1).

If in order to evaluate skin sensitisation potential, a Guinea pig maximisation test was performed, a substance is classified as skin sensitizer sub-category 1B if ≥ 30 % responding at > 1 % intradermal induction dose.

Based on the experimental results, the substance induces no reactions after the intradermal induction dose > 1 %. Therefore, the substance is not classified as skin sensitiser, according to the CLP Regulation (EC) no. 1272/2008.