Registration Dossier
Registration Dossier
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EC number: 402-810-3 | CAS number: 17980-47-1 DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Two in vitro bacterial mutagenicity studies are available for the test substance. In the key study (Huls 1992), no evidence for mutagenicity to bacteria was observed in any of the strains tested. Negative results were also obtained with all strains tested, both with and without activation, in a supporting study (Schöberl 1989).
In vitro cytogenicity and mutagenicity studies in mammalian cells are also available (May 1992 and Ebert 1991, respectively). Both of these studies gave negative results and the test substance was judged to be non-genotoxic in mammalian cells.
Two in vivo studies are available. In the key study ( Huntingdon Research Centre 1988c), negative results were obtained in a mouse micronucleus study. A more recent mouse micronucleus study, for which only a summary report was available, also gave a negative result (Worksafe Toxicology Lab, 1994).
The key studies were selected on the basis of reliability and most recent reports.
Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test) (Schöberl 1989, Huls 1992; rel 2): negative with and without activation in all strains tested (OECD TG 471 1982).
Cytogenicity in mammalian cells (May 1992; rel 2): negative in Chinese hamster lung fibroblasts (V79) (OECD TG 473).
Mutagenicity in mammalian cells (Ebert 1991; rel 2): negative in CHO cells (OECD TG 476).
In vivo:
Single oral exposure to 8800 mg/kg bw in mouse. Micronucleus assay negative for chromosomal aberration (Huntingdon Research Centre 1988c; rel 1) (OECD TG 474).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The available information for triethoxyisobutylsilane (CAS 17980 -47 -1) indicates that it is not mutagenic to bacteria and it is not cytogenic or mutagenic to mammalian cells. In addition, there is no evidence for the induction of micronuclei in vivo. It is therefore considered that classification for mutagenicity is not required in accordance with current regulation (EC 1272/2008).
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