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Administrative data

Description of key information

Skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Guinea pig maximization test

A study was run according to OECD guideline 406 to assess the potential of test substance to induce delayed contact hypersensitivity (skin sensitisation) in the guinea pig. The substance resulted in a sensitization rate of 100 per cent after intradermal induction with 0.5 % test item solution and epicutaneous challenge application of the test item of 25 % to the guinea pig. According to the results, the substance is considered to be sensitising in this test.

Buehler test

A study was run following OECD guideline 406, to assess the skin sensitising potential of test substance in guinea pig. The substance gave no sign of skin sensitisation, indeed 0/20 positive responses were found upon 3 inductions at 25 % in physiological saline (one application per week, occlusive application for 6 h each time) and a challenge at 25 % (2 weeks after the last induction, occlusive application for 6 h, gradings at 24 and 48 h after challenge). The negative control gave 0/10 positive responses. Consequently, the test substance was considered as devoid of a skin sensitising potential in this assay.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Two studies were availble, a GPMT and a Buehler test. Despite the test material was the same, conflicting evidences were found.

Experimental findings in the GPMT would imply a classification as skin sensitizer category 1A according to the CLP Regulation (EC 1272/2008), while experimental results in the Buehler assay would imply no classification.

However, the substance is listed in Annex VI of the CLP Regulation (EC 1272/2008), with index no. 611-016-00-8 and classification as Skin Sens. 1, H317.