2,8,9-Trioxa-5-aza-1-silabicyclo[3.3.3]undecane, 1,1'-(dithiodi-3,1-propanediyl)bis-

Endpoint summary

Additional information

A key bacterial reverse mutation assay conducted in compliance with GLP and according to OECD TG 471 is available for the registered substance. No evidence for a test-substance related increase in the number of revertants was observed in Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A. The strains were treated with doses up to the limit concentration of 5000 µg/plate in two independent experiments without and with metabolic activation (plate incorporation test). No cytotoxicity of the test item was noted in any strain and at any concentration tested. Appropriate positive and solvent controls were included and gave expected results. Under the conditions of this study, the registered substance was concluded to be non-mutagenic to bacteria up to the limit concentration.

 

The key in vitro cytogenicity study on the registered substance was conducted according to OECD TG 473 and to GLP. The test substance did not cause a statistically significant, dose related increase in chromosome aberrations in Chinese hamster lung fibroblasts (V79) with or without metabolic activation. Cytotoxicity of the test item was noted at 33 µg/ml and above after 24 h exposure without metabolic activation and at 300 µg/mL and above after 3-6 h exposure with and without metabolic activation. Appropriate positive and solvent controls were included and gave expected results. The test substance was therefore considered non-clastogenic in Chinese hamster lung fibroblasts (V79).

 

A key mammalian cell gene mutation study conducted in compliance with GLP and according to OECD TG 476 is available for the registered substance. The test substance did not induce mutation at the thymidine kinase locus with or without metabolic activation up to cytotoxic concentrations. Appropriate concurrent negative and positive controls were included and the expected responses were observed. It was therefore concluded that the registered substance was negative for the induction of mutation in mammalian cells under the conditions of the test.

In summary, the available information for the substance indicates that when tested in vitro, Bis(silatranylpropyl)disulfide does not induce mutations in bacterial or mammalian cells, nor chromosome aberrations in mammalian cells. There is no justification from in vitro results for testing in vivo. Therefore, it is considered that classification for mutagenicity is not required.

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

Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in all strains tested (OECD TG 471)
Cytogenicity in mammalian cells: negative in Chinese hamster lung fibroblasts (V79) cells (OECD TG 473)
Mutagenicity in mammalian cells: negative in Chinese hamster lung fibroblasts (V79) cells ( OECD TG 476)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available information on the registered substance is reliable and suitable for classification. The available in vitro data do not meet the criteria for classification for genetic toxicity according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.