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EC number: 273-054-8 | CAS number: 68937-17-7
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2002-0806 to 2003-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. It is considered that read-across to the registered substance is scientifically justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline S2A: Genotoxicity (CPMP/ICH/141/95)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline S2B: Genotoxicity (CPMP/ICH/174/95).
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Chlorodimethylsilane
- EC Number:
- 213-912-0
- EC Name:
- Chlorodimethylsilane
- Cas Number:
- 1066-35-9
- IUPAC Name:
- chloro(dimethyl)silane
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arolor induced rat liver S9
- Test concentrations with justification for top dose:
- 93.6 to 4680 µg/plate for the plate incorporation test and 39 to 1950 µg/plate for the preincubation test
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethylene glycol dimethyl ether
- Justification for choice of solvent/vehicle: solubilty properties and relative nontoxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethylene glycol dimethyl ether
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 without activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-antracene amide
- Remarks:
- TA 98, TA 102, TA 1537 with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 100, TA 1535 with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: other: reduction in number of colonies by more than 50% and/or a scarce background lawn - Evaluation criteria:
- A reproducible and statistically significant increase in the number of revertants by at least two-fold (three-fold for TA 1535 and 1537), and a statistically significant log concentration-dose effect.
- Statistics:
- Mann and Whitney's U-test and Spearman's rank correlation coefficient.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 102, TA 1535 and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1950 µg/plate with and without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
-
PRECIPITATION: no precipitation occurred,
RANGE-FINDING/SCREENING STUDIES: Scarce background lawn was observed at the top concentration in the preliminary cytotoxicity test.
COMPARISON WITH HISTORICAL CONTROL DATA: Not presented in report. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537
Any other information on results incl. tables
Table 1: Dose range-finding study Number of revertants per plate
|
TA100 |
||
Conc. |
- MA plate 1 |
- MA plate 2 |
Cytotoxic |
4680 |
117 |
155 |
yes |
2340 |
127 |
123 |
no |
936 |
139 |
134 |
no |
468 |
125 |
124 |
no |
93.6 |
118 |
129 |
no |
46.8 |
133 |
130 |
no |
9.36 |
133 |
111 |
no |
4.68 |
141 |
125 |
no |
0.936 |
112 |
122 |
no |
0.468 |
128 |
141 |
no |
0* |
134 |
144 |
no |
*solvent control with ethylene glycol dimethyl ether
Table 2: Experiment 1: Plate incorporation.Number of revertants per plate (mean of 3 plates)
|
TA 98 |
TA 100 |
TA 102 |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
4680 |
29.7 |
33.7 |
yes |
167.0 |
156.0 |
yes |
271.7 |
273.3 |
yes |
2340 |
30.0 |
36.7 |
no |
158.3 |
161.0 |
no |
252.7 |
265.7 |
no |
936 |
31.3 |
40.0 |
no |
169.7 |
153.0 |
no |
309.0 |
271.0 |
no |
468 |
32.3 |
45.0 |
no |
165.0 |
139.0 |
no |
283.3 |
274.0 |
no |
93.6 |
30.3 |
39.0 |
no |
165.0 |
154.3 | no |
270.0 |
273.0 |
no |
0* |
35.7 |
45.3 |
- |
164.3 |
151.3 |
- |
289.3 |
281.7 |
- |
Positive control |
774.3 |
773.0 |
- |
809.0 |
813.0 |
- |
1233 |
1221 |
- |
*solvent control with ethylene glycol dimethyl ether
Table 3: Experiment 1: Plate incorporation. Number of revertants per plate (mean of 3 plates)
|
TA 1535 |
TA 1527 |
||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
4680 |
14.3 |
12.7 |
yes |
4.0 |
5.0 |
yes |
2340 |
17.3 |
16.7 |
no |
7.3 |
5.0 |
no |
936 |
17.0 |
15.3 |
no |
4.3 |
7.0 |
no |
468 |
17.3 |
17.0 |
no |
4.7 |
5.7 |
no |
93.6 |
18.0 |
13.7 |
no |
4.0 |
5.0 |
no |
0* |
16.0 |
16.0 |
- |
6.0 |
6.3 |
- |
Positive control |
429.0 |
1500 |
- |
345.7 |
344.0 |
- |
*solvent control with ethylene glycol dimethyl ether
Table 4: Experiment 2: Preincubation.Number of revertants per plate (mean of 3 plates)
|
[Strain a] |
[Strain b] |
[Strain c] |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
1950 |
0 |
0 |
yes |
0 |
0 |
yes |
0 |
0 |
yes |
975 |
29.7 |
30.3 |
yes |
100.0 |
137.7 |
yes |
260.7 |
256.7 |
yes |
390 |
39.0 |
40.0 |
no |
137.0 |
138.3 |
no |
256.3 |
270.7 |
no |
195 |
46.0 |
48.3 |
no |
140.3 |
134.7 |
no |
253.7 |
269.7 |
no |
39 |
37.0 |
39.7 |
no |
156.0 |
144.7 |
no |
259.0 |
265.7 |
no |
0* |
40.0 |
40.0 |
- |
120.3 |
176.0 |
- |
270.0 |
252.3 |
- |
Positive control |
759.3 |
759.7 |
- |
1154.3 |
1132 |
- |
1131.0 |
1223 |
- |
*solvent control with ethylene glycol dimethyl ether
Table 5: Experiment 2: Preincubation.Number of revertants per plate (mean of 3 plates)
|
[Strain a] |
[Strain b] |
||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
1950 |
0 |
0 |
yes |
0 |
0 |
yes |
975 |
14.0 |
13.0 |
yes |
4.0 |
4.0 |
yes |
390 |
14.0 |
14.3 |
no |
5.0 |
5.0 |
no |
195 |
14.3 |
14.7 |
no |
3.3 |
6.0 |
no |
39 |
13.3 |
14.3 |
no |
4.0 |
3.7 |
no |
0* |
15.3 |
15.3 |
- |
6.3 |
6.0 |
- |
Positive control |
336.7 |
336.0 |
- |
351.0 |
352.0 |
- |
*solvent control with ethylene glycol dimethyl ether
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Chlorodimethylsilane, CAS No. 1066-35-9 when tested in OECD 471 under GLP up to 4860 µg/plate caused no mutagenic effect in the Salmonella strains tested in the presence and the absence of metabolic activation either in the plate incorporation or in the preincubation test. It is concluded that the substance is negative for mutagenicity to bacteria under the conditions of the test.
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