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 metabolic activation in all strains tested (OECD TG 471) (WIL, 2014).
Cytogenicity in mammalian cells: negative in Chinese hamster V79 cells (OECD TG 473) (Eurofins, 2018a).
Mutagenicity in mammalian cells: negative with and without metabolic activation in mouse lymphoma L5178Y (OECD TG 490) (Eurofins, 2018b).

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

3-(Triacetoxysilyl)propyl methacrylate has been tested for mutagenicity to bacteria in a study conducted according to OECD 471 and in compliance with GLP. No evidence of test-substance induced increase in the number of revertants was observed with or without metabolic activation in S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 in either the initial plate incorporation experiment or the repeat experiment using preincubation. Toxicity was observed in all tester strains at 1600 and 5000 μg/plate in the preincubation assay, with the highest concentration being non-analysable for revertants. Appropriate solvent and positive controls were included, and gave expected results with the following exception: For strain TA 1537, first experiment without metabolic activation: solvent control mean (25) was slightly above the upper limit of the laboratory historical range (23); only two plates could be determined for the positive control substance. Neither affected the study result. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.

3-(Triacetoxysilyl)propyl methacrylate has been tested for ability to cause chromosome aberrations in Chinese hamster V79 cells according to OECD TG 473 and under GLP (Eurofins, 2018a). No increase in the number of cells with aberrations was observed either with or without metabolic activation in Chinese hamster V79 cells. Appropriate solvent, 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.

3-(Triacetoxysilyl)propyl methacrylate has been tested for mutagenicity to mammalian cells in a study conducted according to OECD TG 490, and in compliance with GLP using mouse lymphoma L5178Y cells (Eurofins, 2018b). No test-substance induced increase in the number of mutations was observed when tested with and without metabolic activation. 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 on the registered substance, 3-[tris(acetoxy)silyl]propyl methacrylate does not require classification for mutagenicity according to Regulation (EC) No 1272/2008.