Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay: the substance 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 (LPT, 2002) (OECD TG 471).


Cytogenicity in mammalian cells: the substance 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was negative with and without metabolic activation in peripheral human lymphocytes (WIL Research, 2016) (OECD TG 473).


Mammalian mutagenicity study: the substance 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was negative with and without metabolic activation in mouse lymphoma L5178Y cells (Charles River, 2016) (OECD TG 490).

The studies were conducted according to an appropriate OECD test guideline, and in compliance with GLP.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

1,3,5-Trimethyl-1,1,3,5,5-pentaphenyltrisiloxane has been tested in a valid bacterial reverse mutation assay, according to the OECD TG 471, and in compliance with GLP, using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 (LPT, 2002). No increase in the number of revertants was observed in any test strain, with or without metabolic activation, up to limit concentration. Appropriate 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.

1,3,5-Trimethyl-1,1,3,5,5-pentaphenyltrisiloxane has been tested in a valid study for ability to induce chromosome aberrations in peripheral human lymphocytes according to OECD TG 473 (2014), and in compliance with GLP. No statistically significant or biologically relevant increase in the number of cells with chromosome aberrations was observed either with or without metabolic activation when tested up to precipitating concentrations. Appropriate positive and negative controls were used and gave the expected results. It is concluded that the test item is negative for the induction of chromosome aberrations under the conditions of the study.

1,3,5-Trimethyl-1,1,3,5,5-pentaphenyltrisiloxane has been tested for mutagenicity in Mouse lymphoma L5178Y cells, according to OECD 490 and in compliance with GLP (Charles River, 2016). No test substance induced increase in the number of mutations was observed when tested up to precipitating concentration. Appropriate solvent and positive controls were included and gave the 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 1,3,5 -trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, no classification is required for genetic toxicity according to Regulation (EC) No 1272/2008.