Registration Dossier

Administrative data

Description of key information

In the key skin sensitisation guinea-pig maximisation (Magnusson and Kligman) study, a delayed contact hypersensitivity response was not elicited (RTC 1996b). The study was conducted according to an OECD guideline 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:

Dimethylbis(octadecyloxy)silane has been tested for in a guinea pig maximisation study using the method of Magnusson and Kligman in a study conducted according to OECD TG 406 and in compliance with GLP. Two weeks after the induction phase of a single intradermal injection of 10% test substance in Alembicol D with and without Freund's adjuvant followed one week later by occlusive application of 75% test substance in Alembicol D the animals were challenged with a 50% solution of test substance in the same vehicle. In the test group, mild reactions to test substance plus vehicle were observed in 2/20 animals and to vehicle alone in a further 2/20 test animals at the 24 hour observation; these were fully resolved by the 48 hour observation. No reactions were observed in any of the 10 negative control animals. It was concluded that the observed effects indicated a mild skin irritation reaction to the vehicle and the test substance was not sensitising to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on a reliable in vivo study dimethylbis(octadecyloxy)silane is not classified as a skin sensitiser according to Regulation 1272/2008. There are no data to suggest that dimethylbis(octadecyloxy)silane is a respiratory sensitiser.