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) (RCC, 2005c).
Cytogenicity in mammalian cells: negative with and without metabolic activation in Chinese hamster V79 cells (OECD TG 473) (RCC, 2005d).
Mutagenicity in mammalian cells: negative with and without metabolic activation in L5178Y cells (OECD TG 476) (Harlan Laboratories, 2010).

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 for tri(isopropyl)silyl acrylate from reliable studies for all the required in vitro endpoints.

Tri(isopropyl)silyl acrylate has been tested for mutagenicity to bacteria, in a study which was conducted according to OECD 471, in compliance with GLP (RCC, 2005c). No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in the experiment, which used Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537, and E. coli WP2 uvrA. The results of the initial experiment using the plate incorporation method were confirmed when the experiment was repeated with preincubation. Appropriate positive, untreated 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.

Tri(isopropyl)silyl acrylate has been tested for cytogenicity in Chinese hamster V79 cells, in a study which was conducted according to OECD 473, in compliance with GLP (RCC, 2005d). No evidence of a test substance related increase in chromosome damage was observed with or without metabolic activation in any of the experiments. Appropriate positive, negative (test medium) and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mammalian cytogenicity under the conditions of the test.

Information on mutagenicity to mammalian cells is available from a reliable study conducted in accordance with OECD 476 and in compliance with GLP (Harlan Laboratories, 2010). No evidence of a biologically significant test-substance induced increase in mutant frequency was observed when tri(isopropyl)silyl acrylate was tested in L5178Y cells with and without metabolic activation up to cytotoxic concentrations in an initial experiment with 4 hours exposure. The results were confirmed in a repeat experiment where cells were exposed for 4 hours with metabolic activation and for 24 hours without metabolic activation. Appropriate positive and solvent controls were included and gave expected results. It is considered that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test.

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, tri(isopropyl)silyl acrylate is not classified for mutagenicity according to Regulation (EC) No 1272/2008.