Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 Escherichia coli WP2 (OECD TG 471) (Dow Corning Corporation (2011d)).
Cytogenicity in mammalian cells: negative with and without activation in cultured human lymphocytes (OECD TG 473) (Dow Corning Corporation (2011c)).
Mutagenicity in mammalian cells: negative with and without activation in L5178Y mouse lymphoma cells (OECD TG 476) (Trenz, K (2012)).

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Data are available from reliable studies for all the required in vitro endpoints. The results of all the studies are in agreement.

3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane has been tested for mutagenicity to bacteria, in a study which was conducted according to OECD 471 and in compliance with GLP (Dow Corning Corporation (2011d)). No evidence of a test substance related increase in the number of revertants was observed with or without metabolic activation in the pre-experiment for toxicity or the initial assay using the plate incorporation method. The result was confirmed the repeat preincubation experiment. The bacteria used were S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2. Appropriate positive, negative and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.

3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane has been tested in an in vitro chromosome aberration assay in peripheral human lymphocytes, conducted according to OECD TG 473 and in compliance with GLP (Dow Corning Corporation (2011c)). No evidence of a test substance related increase in chromosome aberrations was observed with or without metabolic activation in the initial or the repeat experiment. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for cytogenicity under the conditions of the test.

Information on the mutagenicity of 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane to mammalian cells is available from a reliable study conducted according to OECD 476 and in compliance with GLP (Trenz, K (2012)). No evidence for a test-substance induced increase in mutant frequency was observed with or without activation when the substance was tested in mouse lymphoma L5178Y cells up to limit concentrations. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the condition of the study.

In vivo testing is not required as no evidence for genetic toxicity was found in the in vitro studies.


Justification for classification or non-classification

Based on the available in vitro genotoxicity data, 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane is not classified for mutagenicity according to Regulation (EC) No 1272/2008.