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Diss Factsheets

Administrative data

Description of key information

Key study: the test item lacked skin sensitization in the Buehler Topical Closed Patch Skin Sensitization Test according to US EPA 798.4100, GLP study.

Key value for chemical safety assessment

Skin sensitisation

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

Key study: The test item was assessed for skin sensitization potential using the Buehler topical closed patch technique, according to US EPA 798.4100 (GLP study). In a preliminary test, the test item was found to be slightly to moderately irritating at a concentration of 100% and non-irritating at a concentration of 50%. Based on these results, the test item at a concentration of 100% was applied for 6h under a closed patch, once a week for 3 weeks during the induction phase, and once for 24h during the challenge phase. Challenge with the test item following 3 weeks of induction caused no erythema or edema in 10/10 treated animals. No reactions were noted in the negative control group, and 4/4 animals reacted in the positive control group. Consequently, the test item was not considered a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information, the test item is not classified for sensitisation according to CLP Regulation (EC) No. 1272/2008.

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