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Administrative data

Description of key information

One guinea pig maximization test according to OECD guideline 406 (GLP) is available. None of the animals showed signs of skin sensitization.

Key value for chemical safety assessment

Skin sensitisation

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

A sensitization test in albino guinea pigs was performed to determine the contact allergenic potency of the test item. The test was based on OECD Guideline 406.

Induction Day 0 (intradermal injections): Three pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the left and right side of the shaved neck of the test (5 %) and control group animals.

Induction Days 7 and 8 (epidermal application): The application site of all animals was pretreated with 10 % sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. In the test group the test item (50 %) was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (approx. 0.4 g per patch; occluded adiministration for 48 hours). The control group was treated with the vehicle only.

Challenge Days 20 and 21: The test and control group animals were tested on one flank with the test item (50 %) in vaseline (w/w) and on the other flank with the vehicle alone (approx. 0.2 g per patch; occluded administration for 24 hours).

The sensitizing potential was classified according to the grading of Magnusson and Kligman.

Under the experimental conditions chosen, none of the animals of the test group were sensitized 24 and 48 hours after removing the dressings.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No local reactions were observed in a guinea pig maximization test (OECD 406) after an intradermal and epicutaneous induction with 5 % and 50 %, respectively. Therefore, the substance does not require classification as a skin sensitizer under Regulation (EC) No. 1272/2008.