Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial mutagenicity: Negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A (OECD 471) (KTR, 2011)

Cytogenicity in mammalian cells: Negative with and without metabolic activation in Chinese hamster V79 cells (OECD 473) (Eurofins, 2016)

Mutagenicity in mammalian cells: Negative with and without metabolic activation in mouse lumphoma L5178Y cells (OECD 490) (Eurofins, 2017).

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

Additional information

Octaphenylcyclotetrasiloxane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD Test Guideline 471, compliant with GLP (KTR, 2011). 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 or E. coli WP2 uvrA in the initial or the repeat experiments up to cytotoxic/limit concentrations. Appropriate positive and solvent 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.  

Negative results were also reported in a gene mutation study using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2, which supports the findings of the key study (DCC, 1987).

Octaphenylcyclotetrasiloxane has been tested for ability to cause chromosome aberrations in Chinese hamster V79 cells according to OECD Test Guideline 473 and under GLP (Eurofins, 2016). No increase in the number of cells with aberrations was observed either with or without metabolic activation when tested up to a precipitating concentration. 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 the test.  

Octaphenylcyclotetrasiloxane has been tested for mutagenicity in mouse lymphoma L5178Y cells according to OECD Test Guideline 490, and under GLP (Eurofins, 2017). No test-substance induced increase in the number of mutations was observed with or without metabolic activation, 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.

Justification for classification or non-classification

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