Registration Dossier

Administrative data

Description of key information

The key skin sensitisation study is a guideline guinea pig Bühler, non-adjuvant study (Hüls, 1979c) in which a delayed contact hypersensitivity response was not elicited. The study was conducted according to an OECD guideline 406 and in compliance with GLP.

Key value for chemical safety assessment

Skin sensitisation

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

[2-(Perfluorohexyl)ethyl]triethoxysilane has been tested for sensitisation in guinea pigs using the Bühler method in a study conducted according to OECD TG 406 and in compliance with GLP (Hüls, 1997c). After the induction phase of three weekly occlusive applications of undiluted test substance, the animals were challenged with a 50% solution of test substance in corn oil. Observations were made at 30 and 54 hours after the challenge. No sensitisation reactions were observed in any of the 20 test animals or the 10 negative control animals. It is concluded that the test substance is not sensitising under the conditions of the test.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available studies on skin sensitisation, [2-(perfluorohexyl)ethyl]triethoxysilane does not require classification for sensitisation according to Regulation (EC) 1272/2008.