Registration Dossier

Administrative data

Description of key information

Not sensitising to skin as assessed in a guinea pig maximization assays (OECD 406)

Key value for chemical safety assessment

Skin sensitisation

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

A guinea pig maximisation assay according to OECD TG 406 has been performed with the test substance (Clariant, 2001). The maximization test was performed in 15 (10 test and 5 control) female albino guinea pigs. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 10% dilution of the test item in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA) I physiological saline. The epidermal induction of sensitisation was conducted for 48 hours under occlusion with the test item at 30% in PEG 300 one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10 % in PEG 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No toxic symptoms were evident in the guinea pigs of the control or test group. None of the control and test animals showed skin reactions after the challenge treatment at 10 % (w/w) in PEG 300.

Under the conditions of this test, the test substance is not considered to be sensitising to the skin.


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 (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.