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Diss Factsheets
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EC number: 217-007-1 | CAS number: 1719-58-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2009-12-08 to 2009-12-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. The original study was considered reliability 1. Read-across to the registered substance is considered scientifically justified and is reliability 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Dichloro(methyl)(vinyl)silane
- EC Number:
- 204-710-3
- EC Name:
- Dichloro(methyl)(vinyl)silane
- Cas Number:
- 124-70-9
- IUPAC Name:
- dichloro(methyl)vinylsilane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human, from screened donor
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone (80 mg/kg) and β-naphthoflavone (100 mg/kg) induced rat liver S9
- Test concentrations with justification for top dose:
- 44.06 to 1410 μg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: minimal essential medium- Justification for choice of solvent/vehicle: none given in report
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with activation
- Details on test system and experimental conditions:
- - Final concentration of S9: 2%- Cofactors: standardMETHOD OF APPLICATION: in mediumDURATION- Preincubation period: none- Exposure duration: 4 hours (with and without activation); 24 hours (without activation)- Expression time (cells in growth medium): 24 hours- Selection time (if incubation with a selection agent): none- Fixation time (start of exposure up to fixation or harvest of cells): 24 hoursSPINDLE INHIBITOR (cytogenetic assays): Colcemid (0.1 μg/ml) 2 hours before harvestSTAIN (for cytogenetic assays): GiesmaNUMBER OF REPLICATIONS: duplicate culturesNUMBER OF CELLS EVALUATED: 100 per culture, unless 30% cells with aberrations observed, when only 50 cells were evaluatedDETERMINATION OF CYTOTOXICITY - Method: mitotic indexOTHER EXAMINATIONS: - Determination of polyploidy: - Determination of endoreplication: - Other: OTHER:
- Evaluation criteria:
- A positive response was recorded for a particular treatment if the % cells with aberrations, excluding gaps, markedly exceeded that seen in the concurrent control, either with or without a clear dose-relationship. For modest increases in aberration frequency a dose response relationship is generally required and appropriate statistical tests may be applied in order to record a positive response.
- Statistics:
- The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells was compared, where necessary, with the concurrent vehicle control value using Fisher's Exact test.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 705 μg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS- Effects of pH: no significant change in pH- Effects of osmolality: did not increase by more than 50 mOsm- Precipitation: an oily precipitate was observedRANGE-FINDING/SCREENING STUDIES: Doses were based on the results of a range-finding studyCOMPARISON WITH HISTORICAL CONTROL DATA: results were within expected range
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No increase in the number of polyploid cells was detected at any concentration with and without activation (4 and 24 hour treatment)
Table 1 Results of Chromosome Aberration Test – 4(20)-Hours Without Metabolic Activation (S9)
Treatment Group | Mitotic index % | No. of cells scored | Frequency of aberrations with gaps (%) | Frequency of aberrations (without gaps |
Vehicle control | 100 | 200 | 2 (1) | 2 (1) |
352.5 μg/ml | 80 | 200 | 2 (1) | 1 (0.5) |
705 μg/ml | 89 | 200 | 0 | 0 |
1040 μg/ml | 70 | 200 | 1 (0.5) | 1 (0.5) |
Positive control | 10 | 100 | 53 (53.0 | 52 (52.0) |
Table 2 Results of Chromosome Aberration Test – 4(20)-Hours With Metabolic Activation (S9)
Treatment group | Mitotic index % | No. of cells scored | Frequency of aberrations with gaps (%) | Frequency of aberrations without gaps (%) |
Vehicle control | 100 | 200 | 4 (2.0) | 1 (0.5) |
176.25 μg/ml | 94 | 200 | 1 (0.5) | 0 |
352.5 μg/ml | 91 | 200 | 2 (1.0) | 2 (1.0) |
705 μg/ml | 89 | 200 | 3 (1.5) | 2 (1.0) |
1410 μg/ml | 115 | 200 | 0 | 0 |
Positive control CP 5 μg/ml | 12 | 100 | 38 (38) | 31 (31) |
Table 3 Results of Chromosome Aberration Test – 24-Hours Without Metabolic Activation (S9)
Treatment | Mitotic index % | No of cells scored | Total number of aberrations with gaps (%) | Total number of aberration without gaps (%) |
Vehicle control | 100 | 200 | 1 (0.5) | 1 (0.5) |
88.03 μg/ml | 114 | 200 | 7 (3.5) | 3 (1.5) |
176.25 μg/ml | 81 | 200 | 2 (1.0) | 2 (1.0) |
352 μg/ml | 64 | 200 | 4 (2.0) | 2 (1.0) |
705 μg/ml | 34 | 200 | 6 (3.0) | 2 (1.0) |
Positive control MMC 0.2 μg/ml | 15 | 100 | 76 (76.0) | 74 (74.0) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative with and without activationDichloro(methyl)(vinyl)silane has been tested in a valid and reliable in vitro chromosome aberration assay according to OECD TG 473 and under GLP. No increase in the frequency of aberrations resulting from treatment with the test substance was detected. The expected results were obtained with vehicle and positive controls. It is concluded that the test substance is negative for the induction of chromosome aberrations in mammalian cells under the conditions of the test.
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