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Key value for chemical safety assessment

Additional information

Information is available from reliable studies for all the required in vitro endpoints. The results of most of the studies were in agreement. A positive result was obtained in one study in a single strain of bacteria in the presence of activation, but only when ethanol was used as the solvent. This result was not confirmed in a more recent study also using ethanol as solvent, nor in the other available bacterial mutagenicity assays, so it is concluded that the positive response was not biologically relevant, and the most recent study was chosen as the key study.


Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in all strains tested (OECD TG 471)
Cytogenicity in mammalian cells: negative in cultured human lymphocytes (OECD TG 473)
Mutagenicity in mammalian cells: negative in L5178Y mouse lymphoma cells (OECD TG 476)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available information for the substance indicates that when tested in vitro, (3-chloropropyl)triethoxysilane (CAS number 5089 -70 -3) does not induce mutations in bacterial or mammalian cells, nor chromosome aberrations in mammalian cells. There is no justification from in vitro results for testing in vivo. Therefore it is considered that classification for mutagenicity is not required.