Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay: tetradecamethylhexasiloxane was negative, with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 (OECD 471, 1997) (BSL Bioservice, 2014).
Mammalian cytogenicity assay: tetradecamethylhexasiloxane was negative, with and without metabolic activation in Chinese hamster lung fibroblasts (V79) (OECD 473, 1997) (Bioservice, 2015).
Mammalian mutagenicity assay: tetradecamethylhexasiloxane was negative, with and without metabolic activation in mouse lymphoma L5178Y cells (OECD476, 1997) (Eurofins, 2015).

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Tetradecamethylhexasiloxane has been tested in a valid bacterial reverse mutation assay, according to the OECD TG 471, and under GLP, using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or TA 102 (BSL Bioservice, 2014).

No increase in the number of revertants was observed in any test strain, with or without metabolic activation, when tested up to limit concentration. Appropriate negative, positive and solvent controls were added and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test. The study was considered reliability 1.

Tetradecamethylhexasiloxane has been tested for ability to cause chromosome aberrations in Chinese hamster lung fibroblasts (V79) according to OECD TG 473 and under GLP (Bioservice, 2015). No increase in the number of cells with aberrations was observed either with or without metabolic activation in Chinese hamster V79 cells, when tested up to precipitating concentrations. Appropriate negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of this study. The study was considered reliability 1.

Tetradecamethylhexasiloxane has been tested for mutagenicity in mouse lymphoma L5178Y cells according to OECD TG 476, and under GLP (Eurofins, 2015). No test-substance induced increase in the number of mutations was observed, when tested up to precipitating concentrations. Appropriate solvent, negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the study. The study was considered reliability 1.

Tetradecamethylhexasiloxane contains no structural elements which may be of concern for potential mutagenic activity. In vitro tests are negative, including a bacterial mutagenicity, mammalian cytogenicity and mammalian mutagenicity studies, therefore in vivo testing is not required.




Justification for classification or non-classification

Based on the available data for tetradecamethylhexasiloxane, no classification is required for genetic toxicity according to Regulation (EC) No 1272/2008.