Registration Dossier

Administrative data

Description of key information

van Huygevoort (2003) performed a skin sensitisation test according to OECD Guideline 408, EPA OPPTS guideline 870.2600 and a Japanese Test Guideline based on the method described by Magnusson and Kligman. In this K1 test XTJ 568 was observed not to be sensitising in male/female Dunkin-Hartley guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

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

van Huygevoort (2003) assessed contact hypersensitivity of XTJ 568 in the Albino Guinea Pig (Maximisation Test). The study was carried out based on the guidelines described in EC Commission Directive 96/54/EC, Part B.6, "Skin sensitisation", OECD No. 406, "Skin sensitisation", EPA OPPTS 870.2600 " Skin sensitisation" and JMAFF: Japanese Test Guidelines and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens".

Test concentrations selected for the main study were based on the results of a preliminary study.

In the main study, ten experimental animals were intradermally injected with a 0.1% concentration and epidermally exposed to a 2% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). Two weeks after the epidermal application all animals were challenged with a 1% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. There was no evidence that the substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available test results and according to the CLP Regulation, the substance needs not to be classified as a skin sensitiser.