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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay: the substance Reaction mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers was negative with and without activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 (OECD TG 471) (Dow Corning Corporation, 1990).

Cytogenicity in mammalian cells: the substance Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers was negative with or without metabolic activation in Chinese hamster ovary cells (OECD TG 473) (Bioreliance, 2001)

Mutagenicity in mammalian cells: the substance Reaction mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers was negative without metabolic activation and positive with metabolic activation in L5178Y mouse lymphoma cells (OECD TG 490) (Charles River, 2017).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Additional information

Reaction mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers has been tested in a valid bacterial reverse mutation assay, according to the OECD TG 471 (1989), and in compliance with GLP, using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 (Dow Corning Corporation, 1990). No increase in the number of revertants was observed in any test strain, with or without metabolic activation. 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.

Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers has been tested for ability to cause chromosome aberrations in Chinese hamster ovary cells according to OECD TG 473 and in compliance GLP (Bioreliance, 2001). No increase in the number of cells with aberrations was observed either with or without metabolic activation in Chinese hamster ovary cells. Appropriate solvent 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.

Reaction mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers has been tested for mutagenicity in Mouse lymphoma L5178Y cells according to OECD TG 490, and in compliance with GLP (Charles River, 2017). No test-substance induced increase in the number of mutations was observed when the substance was tested in the absence of metabolic activation. The test item induced an 18-fold and 9.5-fold dose related increase in the mutation frequency at  concentrations of 1000 and 500 µg/ml, respectively,  in the presence of metabolic activation. This  increase was above the 95% control limits of the distribution of the historical negative control database and also above the GEF + MF(controls). Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is positive for mutagenicity to mammalian cells under the conditions of the study.

Justification for classification or non-classification

Based on the available data for reaction mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers, no classification/classification is required for genetic toxicity according to Regulation (EC) No 1272/2008.