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EC number: 222-123-0 | CAS number: 3353-69-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-11-02 to 2016-03-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 2014
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Ethane-1,2-diylbis[dichloromethylsilane]
- EC Number:
- 222-123-0
- EC Name:
- Ethane-1,2-diylbis[dichloromethylsilane]
- Cas Number:
- 3353-69-3
- Molecular formula:
- C4H10Cl4Si2
- IUPAC Name:
- dichloro({2-[dichloro(methyl)silyl]ethyl})methylsilane
- Reference substance name:
- 1,2-bis[dichloro(methyl)silyl]ethane
- IUPAC Name:
- 1,2-bis[dichloro(methyl)silyl]ethane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: minimum essential medium (MEM)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital (80 mg/kg bw) and -naphthoflavone (100 mg/kg bw) induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I:
200, 400, 600 and 800 μg/mL, without metabolic activation
500, 1000 and 1500 μg/mL, with metabolic activation
Experiment II:
400, 600, 800 and 1000 μg/mL, without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran (THF)
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the cells and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
ACTIVATION: The S9 supernatant was mixed with S9 co-factors to result in a final protein concentration of 0.75 mg/mL in the cultures. The added co-factors were: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 5 mM NADP in 100 mM sodium-phosphate-buffer pH 7.4.
DURATION
- Exposure duration:
Experiment I: 4 hours exposure, with and without metabolic activation
Experiment II: 21 hours exposure, without metabolic activation
- Expression time (cells in growth medium):
Experiment I: 16 +/- 2 hours
Experiment II: Preparation of the cells straight after the 21-hour exposure
- Fixation time (start of exposure up to fixation or harvest of cells): at 21 hours after the start of exposure
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (0.2 μg/mL culture medium) ) added 2.5 hours before cell preparation
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: Duplicate cultures
NUMBER OF CELLS EVALUATED: 150 metaphases per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index and RICC (%) (relative increase in cell count)
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- The result was considered positive when:
- at least one of the test concentrations exhibits a statistically significant increase compared with the concurrent negative control
- the increase is dose-related when evaluated with an appropriate trend test
- any of the results are outside the distribution of the historical negative control data - Statistics:
- Fisher´s exact test - to verify the results in the experiment
Χ2 test for trend - to test whether there is a concentration-related increase in cells with chromosome aberrations
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 800 μg/mL without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test item was noted at 1000 μg/mL in experiment I with metabolic activation and experiment II without metabolic activation.
ADDITIONAL INFORMATION ON CYTOTOXICITY: In experiment I without metabolic activation at concentration of 800 μg/mL, only one of the two cultures was evaluated for mitotic index and aberrant cells. - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 1: Summary, Experiment I and II with and without metabolic activation
|
Dose Group |
Concentration µg/mL |
Relative Mitotic Index (%) |
RICC (%) |
Mean % Aberrant Cells |
Historical Laboratory Negative Control Range |
Precipitation |
||
Including Gaps |
Excluding Gaps |
||||||||
Experiment I and II, without metabolic activation |
|||||||||
Experiment I 4 hour treatment, 21 hour preparation interval |
C |
0 |
102 |
114 |
2.3 |
0.7 |
0.0% - 4.0 % aberrant cells |
- |
|
S |
0 |
100 |
100 |
2.3 |
0.7 |
- |
|||
aC |
0 |
97 |
97 |
2.0 |
1.7 |
- |
|||
3 |
200 |
92 |
85 |
5.0 |
2.0 |
- |
|||
4 |
400 |
98 |
75 |
3.3 |
2.3 |
- |
|||
5 |
600 |
92 |
72 |
3.0 |
2.3 |
- |
|||
6 |
800 |
39 |
7 |
2.7 |
2.0 |
- |
|||
EMS |
600 |
94 |
78 |
10.0 |
6.0 |
- |
|||
|
|||||||||
Experiment II 21 hour treatment, 21 hour preparation interval |
C |
0 |
102 |
110 |
1.3 |
0.3 |
0.0 % - 4.0 % aberrant cells |
- |
|
S |
0 |
100 |
100 |
1.7 |
0.7 |
- |
|||
aC |
0 |
74 |
114 |
3.3 |
1.7 |
- |
|||
6 |
400 |
89 |
88 |
1.7 |
1.0 |
- |
|||
7 |
600 |
65 |
87 |
2.3 |
1.7 |
- |
|||
8 |
800 |
8 |
25 |
1.2 |
0.8 |
- |
|||
9 |
1000 |
13 |
31 |
4.9 |
1.8 |
+ |
|||
EMS |
600 |
70 |
78 |
17.3 |
15.7 |
- |
|||
Experiment I, with metabolic activation |
|||||||||
Experiment I 4 hour treatment, 21 hour preparation interval |
C |
0 |
106 |
103 |
2.0 |
1.3 |
0.0 % - 4.3 % aberrant Cells |
- |
|
S |
0 |
100 |
100 |
3.0 |
2.0 |
- |
|||
aC |
0 |
113 |
114 |
3.3 |
1.3 |
- |
|||
5 |
500 |
117 |
91 |
5.0 |
2.7 |
- |
|||
6 |
1000 |
119 |
80 |
6.0 |
3.3 |
+ |
|||
7 |
1500 |
116 |
88 |
3.3 |
1.7 |
+ |
|||
CPA |
1.5 |
115 |
78 |
10.0 |
5.7 |
- |
C: Negative Control (Culture Medium)
S: Solvent Control (DMSO)
aC: Acidic Control
CPA: Cyclophosphamide
EMS: Ethylmethanesulfonate
+ : Precipitation
- : No precipitation
Applicant's summary and conclusion
- Conclusions:
- 1,2-Bis[dichloro(methyl)silyl]ethane has been tested for ability to cause chromosome aberrations in Chinese hamster lung fibroblasts V79 according to OECD TG 473 and in compliance with GLP (Eurofins BioPharma, 2016). No increase in the number of cells with aberrations was observed either with or without metabolic activation up to cytotoxic or precipitating concentrations. Appropriate solvent (THF), negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of this study.
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