Registration Dossier
Registration Dossier
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EC number: 943-282-9 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial reverse mutation assay: negative in Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100, and Escherichia coli WP2uvrA (OECD 471) (Charles River, 2016)
Chromosome aberration study in mammalian cells: negative in peripheral human lymphocytes, with and without metabolic activation (OECD 473) (Charles River, 2016)
Mammalian cell gene mutation: negative in Mouse lymphoma L5178Y cells, with and without metabolic activation (OECD TG 490) (Charles River, 2017)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silanew as tested in a valid bacterial reverse mutation assay, conducted according to OECD TG 471 and in compliance with GLP using Salmonella typhimurium strains (TA1535, TA1537, TA98 and TA100) and Escherichia coli (WP2uvrA). No increase in the number of revertant was observed in any test strains, with or without metabolic activation, when tested up to precipitating concentrations. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test (Charles River, 2016).
Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane has been tested for ability to cause chromosome aberrations in peripheral human lymphocytes, according to OECD 473 and under GLP (Charles River, 2016). No increase in the number of cells with aberrations was observed either with or without metabolic activation when tested up to a precipitating concentration. Appropriate negative (solvent) and positive controls were included and gave the expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations under the condition of the study.
Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane has been tested for mutagenicity in Mouse lymphoma L5178Y cells, according to OECD TG 490, and under GLP (Charles River, 2017). No test-substance induced increase in the number of mutations was observed when tested up to a precipitating concentration. Appropriate solvent and positive controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test.
Justification for classification or non-classification
Based on the available data for Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane, no classification is required for genetic toxicity according to Regulation (EC) No 1272/2008.
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