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Key value for chemical safety assessment

Additional information

Information is available from reliable studies on triethoxy(3-thiocyanatopropyl)silane from in vitro mutagenicity studies using bacterial and mammalian cells and from an in vitro cytogenicity study.

Triethoxy(3-thiocyanatopropyl)silane has been tested in a reliable study conducted in accordance with OECD 471 (1997) and in compliance with GLP using Salmonella typhimurium strains TA 98, 100, 1535, 1537 and 1538, and E.coli WP2uvrA (Diefenbach (2000)). No evidence of test substance induced increase in the number of revertants was observed up to limit concentrations in any of the bacteria tested without and with metabolic activation in either the initial plate incorporation assay or the repeat experiment using the preincubation method. Appropriate untreated, solvent and positive controls were included and gave expected results. It is concluded that the test substance is non-mutagenic under the conditions of the test.

Information on the potential for triethoxy(3-thiocyanatopropyl)silane to cause chromosome aberrations in mammalian cells is available from a reliable study conducted according to OECD TG 473 and in compliance with GLP (Oppong-Nketiah, M. (2012)). A dose-related increase in the number of aberrations was observed at all concentrations tested with and without metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is clastogenic (causes structural aberrations in chromosomes) under the conditions of the test. No evidence of polyploidy was observed.

Triethoxy(3-thiocyanatopropyl)silane has been tested for mutagenicity to mammalian cells in a reliable study conducted according to OECD TG 476 and in compliance with GLP using L5178Y cells. A dose-related increase in mutant frequency above the global evaluation factor was observed at concentrations of 1mM and above in the main experiment with metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is therefore concluded that the test substance is mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells. No clastogenic effects (increase in number of small colonies) were observed in this study.

Evidence of clastogenicity and mutagenicity to mammalian cells was obtained from the in vitro cyotgenicity and mutagenicity studies using mammalian cells. It is therefore proposed that an in vivo micronucleus study be conducted.


Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 (OECD TG 471) (Diefenbach (2000)).
Cytogenicity in mammalian cells: positive with and without metabolic activation in Chinese hamster V79 cells (OECD TG 473) (Oppong-Nketiah, M. (2012))
Mutagenicity in mammalian cells: positive with metabolic activation in mouse lymphoma L5178Y cells (OECD TG 476) (Trenz (2012)).

In vivo:
An in vivo micronucleus study is proposed.

Endpoint Conclusion:

Justification for classification or non-classification