Dichloromethyl(3,3,3-trifluoropropyl)silane

Endpoint summary

Additional information

In vitro genotoxicity data:

In the available key study (Dow Corning Corporation, 1979), which predates GLP, the test item was tested for bacterial mutagenicity (Ames Test) equivalent or similar to the OECD TG 471. The Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100 were exposed to the test material both in absence and presence of a metabolic activation system. No treatment related increase in the number of revertants was observed in any of the tester strains. Appropriate solvent and positive controls were included into the test and gave the expected results. Hence, the test item was considered to be non-mutagenic to bacteria under the conditions of the test.

No data are available for mutagenicity to a bacterial strain capable of detecting cross-linking or oxidising mutagens. In view of the lack of genetic toxicity demonstrated in studies on mammalian cells, and the absence of structural features that indicate that such mutagenicity is likely, testing in an appropriate 5th strain is not considered necessary. In addition, the only silicon-containing substance which has given a positive result in a bacterial strain capable of detecting cross-linking or oxidising mutagens contains an epoxy- side-chain (which is associated with cross-linking mutagenicity), and this substance was positive in Salmonella typhimurium strains TA 100, TA 1535 as well as in E.coli WP2uvrA

 

In the available key study (BSL, 2012b) the test item was tested for mammalian cytogenicity in vitro. The study was performed according to the OECD TG 473, and in compliance with GLP. Chinese hamster V79 cells were treated with the test item with and without metabolic activation up to precipitation and cytotoxicity concentrations. Following exposure (4 h with and without metabolic activation in Experiment I and 4 h with and 20 h without metabolic activation in Experiment II) the chromosomes were prepared and at least 100 metaphases per culture were scored for structural chromosomal aberrations. In both experiments, no biologically relevant increase of the aberration rates was found after treatment with the test item with and without metabolic activation. The aberration rates of all dose groups treated with the test item were within the historical control data of the negative control. Furthermore, no biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item as compared to the controls. Appropriate positive and negative controls were included in the study and gave the expected results. Hence, the test item is considered to be non-clastogenic under conditions of the test.

 

In the available key study (BSL, 2012a) the test material was investigated for mammalian mutagenicity according to the OECD test guideline 476, and in compliance with GLP. In two independent experiments mouse lymphoma L15178Y cells were treated with the test item up to cytotoxic concentrations both in the presence and absence of a metabolic activation system for 4 h and 24 h, respectively. No biologically relevant increase in mutant frequency was observed in any experiment without metabolic activation. A positive result was obtained from the first experiment with metabolic activation; however, this could not be confirmed in the second experiment. Hence, the test material was considered to be not mutagenic to mammalian cells under the conditions of the test.

In vivo genotoxicity data:

No data available.

Justification for selection of genetic toxicity endpoint
No study was selected, since all available studies were negative.

Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, and TA 100: negative with and without metabolic activation (similar to OECD TG 471)
Mammalian cytogenicity (Chinese hamster V79 cell chromosome aberration assay): negative with and without metabolic activation (according to OECD TG 473)
Mammalian mutagenicity (Mouse Lymphoma Assay): negative with and without metabolic activation (according to OECD TG 476)
In vivo:
No data available.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data classification for genetic toxicity according to Regulation 67/584/EEC and (EC)1272/2008 is not warranted.