Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The key sensitisation study is the only available study for this endpoint. The test was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP, and was therefore assigned Reliability 1.

Migrated from Short description of key information:
In the key skin sensitisation study, conducted in accordance with OECD 406 (Buehler method) and in compliance with GLP, tetramethylsilane was not sensitising in the guinea pig (Huls, 1998e). No skin reactions were observed at challenge.

Justification for classification or non-classification

Based on a reliable in vivo study, tetramethylsilane is not classified as a skin sensitiser according to EU Directive 67/548/EEC and Regulation 1272/2008.

There are no data to suggest that tetramethylsilane is a respiratory sensitiser.