Registration Dossier
Registration Dossier
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EC number: 445-890-5 | CAS number: 201290-01-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial mutagenicity (Ames test): negative with and without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli WPuvrA (Genetic Laboratory, 2003)
Cytogenicity in mammalian cells: negative with and without metabolic activation in human lymphocytes (Huntingdon, 2004).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane has been tested in a valid bacterial reverse mutation assay, according to a protocol similar to OECD TG 471 and in compliance with GLP, using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli WPuvrA (Genetic Laboratory, 2003). No increase in the number of revertants was observed in any test strain, with or without metabolic activation when tested up to a limit 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 bacteria under the conditions of the test.
N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane has been tested for ability to cause chromosome aberrations in Human lymphocytes, according to OECD TG 473 with acceptable restrictions and in compliance with GLP (Huntingdon, 2004). Even though a statistically significant increase in the number of cells with aberrations was observed in Test 1, without metabolic activation, no dose response relationship was noted. Moreover, no increase in the number of cells with chromosome aberrations was observed either with or without metabolic activation system in a repeated test or continuous exposure test when tested up to a limit concentration. Appropriate 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 conditions of the test.
Justification for classification or non-classification
Based on the available data for N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane, no classification is required for genetic toxicity according to Regulation (EC) No 1272/2008.
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