Registration Dossier
Registration Dossier
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EC number: 242-560-0 | CAS number: 18765-38-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse mutation assay / Ames test): negative
with and without metabolic activation in Salmonella typhimurium TA 1535,
TA 1537, TA 98, TA 100 and TA 1538 (EU Method B.13/14) (Hüls, 1992d).
The selected key study was conducted according to appropriate national
standard methods and in compliance with GLP.
Cytogenicity in mammalian cells: negative with and without metabolic
activation in Chinese hamster V79 cells (OECD 473, 2014) (Eurofins,
2015).
Mutagenicity in mammalian cells: negative with and without metabolic activation in Mouse lymphoma L5178Y cells (OECD 490) (Eurofins, 2016).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Tetrakis(2 -butoxyethyl) orthosilicate has been tested in a study conducted according to EU Method B.13/14 and in compliance with GLP (Hüls, 1992d). No increase in the number of revertants was observed in the presence or absence of metabolic activation when tested at concentrations up to 5000 µg/plate. The observations made in the initial dose-ranging study were reproduced in the main test. The strains tested were Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538, and duplicate plates were used. Appropriate vehicle and positive controls were used and gave expected responses.
Tetrakis(2-butoxyethyl)silicate has been tested in a valid study according to OECD 473 and under GLP, up to precipitation concentrations 1 μg/mL and 20 μg/mL. No increase in the number of cells with aberrations was observed either with or without metabolic activation in Chinese hamster lung fibroblasts (V79). 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.
Tetrakis(2-butoxyethoxy)silane has been tested for mutagenicity in Mouse lymphoma L5178Y cells according to OECD TG 490, and under GLP (Eurofins, 2016). No test-substance induced increase in the number of mutations was observed. Appropriate solvent, negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the study.
Justification for classification or non-classification
Based on the available in vitro genotoxicity data, tetrakis(2-butoxyethyl) orthosilicate is not classified for mutagenicity according to Regulation (EC) No 1272/2008.
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