Registration Dossier
Registration Dossier
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EC number: 200-902-6 | CAS number: 75-79-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Information is available from reliable studies for all the required in vitro endpoints. Where there was more than one result for an endpoint the most reliable study available was chosen as key study. The key in vitro cytogenicity study showed slight evidence of effects, but in the opinion of the reviewer these were not biologically significant as the increase in aberrations was very slight and not dose related. There is also data from a sister chromatid exchange assay, which showed an increase in SCE's per cell but not in the number of cells with SCEs. As this is not a standard REACH endpoint, the result does not affect the overall conclusion. An in vitro unscheduled DNA synthesis assay and an E coli pol A assay also gave negative results.Data from an in vivo Mammalian bone marrow chromosome aberration test (ip study) in rat support the negative conclusion, but the study did not demonstrated toxicity to the target organ, so it is not included in the key studies.
Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in all strains tested (similar to OECD TG 471)
Cytogenicity in mammalian cells: negative in cultured human lymphocytes without activation (similar to OECD TG 473)
Mutagenicity in mammalian cells: negative in L5178Y mouse lymphoma cells (similar to 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, trichloro(methyl)silane (CAS number 75 -79 -6) did not induce mutations in bacterial, mammalian or yeast cells. The in vitro cytogenicity study did not indicate a biologically significant clastogenicity (induction of chromosome aberrations). An in vitro unscheduled DNA synthesis assay and an E coli pol A assay also gave negative results. It is concluded that classification for mutagenicity is not required.
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