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Administrative data

Description of key information

The test article was found to be non sensitizing in the guinea pig maximization test. The study was performed according to OECD testing guideline 406 and under GLP. For intradermal induction, 5% in arachis oil was applied which was the highest obtainable concentration. For epicutaneous induction, the irritating concentration of 50% in petrolatum was applied. In the challenge application, the highest non irritating concentration of 30% was used. None of the animals showed skin reactions at the first and second reading after challenge.

Key value for chemical safety assessment

Skin sensitisation

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

For the assessment of skin sensitization, one study is available that is adequately performed and reported to serve as key study.The study was performed according to OECD testing guideline 406 and under GLP with a well-characterized sample of 95% purity. Pirbright White guinea pigs were used. For intradermal induction, 5% in arachis oil was applied which was the highest obtainable concentration. For epidermal induction, the irritating concentration of 50% in petrolatum was applied. Induction treatments were done with FCA/saline; test item/vehicle; test item/FCA/saline (intradermal induction); test item/vaseline (epidermal induction). For the challenge application, the highest non irritating concentration of 30% was used. None of the animals showed skin reactions at the first and second reading after challenge. No reactions were observed in the animals of the control group. The sensitivity of the guinea pig strain was confirmed by an experiment using potassium dichromate, in which after 48 h challenge, 7 out of 10 animals were positive. After 72 hours 6 out of 10 animals were still positive.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No experimental data is available.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.