Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.