Registration Dossier

Administrative data

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:

The sensitizing potential of substance was tested after intradermal injections and cutaneous applications in ten male and ten female Albino Guinea Pigs, to the method established by B. Magnusson and A. Kligman *. The intradermal induction was performed at the concentration of 2.5 % in distilled water. In the epicutaneous induction and in the challenge patch with undiluted test item were used. The behaviour of the animals was not influenced by the treatment. Due to the staining of the skin, no local reaction was noted 24 h and 48 h after removal of the challenge patch test.

Skin samples of both flanks were taken and fixed in formalin 10 %. Histological examination of the skin samples did not reveal evidence of a sensitization reaction.

In conclusion, under the experimental conditions, the test sample did not provoke any cutaneous sensitization in the guinea pig.

 

*MAGNUSSON B. - KLIGMAN A.M. The identification of contact allergens by animal assay "The guinea pig maximization test". J. Invest. Derm. 1969,52,3,268-276

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the CLP Regulation (EC 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 1272/2008).