Registration Dossier
Registration Dossier
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EC number: 216-467-0 | CAS number: 1591-02-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Dibutoxy(dimethyl)silane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, in compliance with GLP (BSL Bioservice, 2015f). No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 in the initial plate incorporation assay or the repeat experiment conducted using the preincubation method, up to limit concentrations. Appropriate positive, solvent and negative (water) controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
Justification for selection of genetic toxicity endpoint
Conclusion based on the following assay: Bacterial reverse mutation assay (Ames test). The selected study is the only available study for the registered substance. It was conducted according to OECD 471 (1997) and in compliance with GLP.
Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 (OECD 471) (BSL Bioservice, 2015f).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available in vitro bacterial mutagenicity data, dibutoxy(dimethyl)silane does not require classification for mutagenicity according to Regulation (EC) No. 1272/2008.
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