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Diss Factsheets
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EC number: 477-700-1 | CAS number: 883794-93-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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