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Diss Factsheets
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EC number: 213-600-4 | CAS number: 993-00-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- 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:
- 1981-02-04 to 1981-12-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to an appropriate national test guideline, and in compliance with GLP, with the following restrictions: mitotic index was determined in only 500 cells /animal, results are not presented in compliance with current guideline. Read-across to the registered substance is considered scientifically justifiable.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- number of cells evaluated; only male animals used
- Qualifier:
- according to guideline
- Guideline:
- other: EPA TAP 22: 269-275, 1972 modified 12/3 to 12/5 1980
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Dichloro(dimethyl)silane
- EC Number:
- 200-901-0
- EC Name:
- Dichloro(dimethyl)silane
- Cas Number:
- 75-78-5
- IUPAC Name:
- dichloro(dimethyl)silane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gofmoor Farms, Westboro, MA (range-finding study); Charles River, Wilmington, MA USA (main study)
- Age at study initiation: 10-14 weeks
- Weight at study initiation: 200-250 g
- Assigned to test groups randomly: not reported
- Fasting period before study:
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: paraffin oil
- Justification for choice of solvent/vehicle: Paraffin oil used as test article is reactive with water
- Concentration of test material in vehicle: not reported
- Purity: laboratory grade - Duration of treatment / exposure:
- single injection
- Frequency of treatment:
- Once
- Post exposure period:
- sacrifice at 6, 24 and 48 hours after exposure.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
11, 22, 32 mg/kg bw
Basis:
other: Criteria for selection of MTD based on the results of a range-finding study
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - cyclophosphamide;
- Justification for choice of positive control(s): none given
- Route of administration: not reported
- Doses / concentrations: 22 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Based on range finding study
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): single treatment, sampling times: 6, 24 and 48 hours
DETAILS OF SLIDE PREPARATION: Cells were centrifuged and resuspended three times in fixative (3:1 methanol:acetic acid). Aliquots of suspended cells were air dried. Slides of acceptable quality were stained with 5% Giesma, and photographed using x100 objective.
METHOD OF ANALYSIS: Negatives were projected onto a white counter and examined for chromosomal breaks or gaps, chromatid breaks or gaps, complex rearrangenemts, pulverised cells or chromosomes, acentric fragments, polyploidy and large translocations or deletions.
- Evaluation criteria:
- None given in report
- Statistics:
- Chi squared test and Wilcoxon test.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- deaths at 22 mg/kg and above
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Results of range-finding studies
|
Table 2: Results of chromosome analysis in bone marrow(5 animals per dose, approx 110 cells per animal evaluated)
- |
Positive control |
Vehicle control |
11mg/kg |
22 mg/kg |
32 mg/kg |
||||||||
Sampling time (h) |
24 |
6 |
24 |
48 |
6 |
24 |
48** |
6 |
24 |
48 |
6 |
24 |
48 |
Gaps |
ND |
0-4 |
0-6 |
0-4 |
2-6 |
1-7 |
0-1 |
1-5 |
0-4 |
0-2 |
2-10 |
1-7 |
1-5 |
Breaks |
3 -> 23 |
0-4 |
0-2 |
0-3 |
0-5 |
0-7 |
0-2 |
0-2 |
0-2 |
0-2 |
1-5 |
0-5 |
1-2 |
Other |
0 -5*** |
0-2* |
0-1* |
0-1* |
0 |
0-2* |
0-2* |
0 |
3* |
0-2* |
0 |
0-2* |
0 |
Mitotic index % |
1.3-3.1 |
1.7-5.0 |
1.4-3.7 |
1.2 -6.5 |
0.8-5.8 |
2.1-5.8 |
1.0-4.3 |
2.0-4.7 |
1.8-5.8 |
1.4 -6.2 |
2.3-4.5 |
1.8-4.3 |
1.7-3.4 |
Polyploidy |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endo reduplication |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Numbers in table represent the range of the mitotic index or the total number of gaps, breaks or other aberrations recorded for each test animal
ND Not determined
* deletions
** 7 animals used at this dose and time, 2 with under 50 analysable cells.
*** Including deletions, triradials and quad -radials
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test substance did not induce chromosome aberrations when tested in male rats by ip injection using a procedure similar to OECD 475. It is concluded that the test substance is not genotoxic under the conditions of the test.
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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