Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA / pKM101 (OECD TG 471) (Japan Bioassay Research Center 2001a).

Cytogenicity in mammalian cells: negative with and without metabolic activation in Chinese hamster lung IU cells (OECD TG 473) (Japan Bioassay Research Center 2001b).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Trimethylsilane has been tested in a study conducted according to a national standard (Japanese) method that is similar to OECD 471, and in compliance with GLP (Japan Bioassay Research Center 2001a). No increase in the number of revertants was observed in the presence or absence of metabolic activation when tested using the gas exposure method at concentrations up to 50%. The observations made in the initial dose-ranging study were reproduced in the main test. The strains tested were Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA / pKM101, and duplicate plates were used. Appropriate vehicle (air) and positive controls were used and gave expected responses; only 2-aminoanthracene was used as positive control with metabolic activation.

Trimethylsilane has been tested according to a national standard method (Japanese) that is equivalent to OECD 473, and in compliance with GLP. No increase in the incidence of chromosome aberrations was observed when tested using a gas exposure method at concentrations up to 80% with and without metabolic activation in Chinese hamster lung cells. Appropriate vehicle and positive controls were used and gave expected results. It is concluded that the test material is negative for the induction of chromosome aberrations under the conditions of the test.


Justification for classification or non-classification

Based on the available in vitro genotoxicity data, trimethylsilane is not classified for mutagenicity according to Regulation (EC) No 1272/2008.