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EC number: 242-042-4 | CAS number: 18162-48-6
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-04-18 to 2002-07-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC directive 92/69/, L383 A part B, 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- tert-butylchlorodimethylsilane
- EC Number:
- 242-042-4
- EC Name:
- tert-butylchlorodimethylsilane
- Cas Number:
- 18162-48-6
- Molecular formula:
- C6H15ClSi
- IUPAC Name:
- tert-butyl(chloro)dimethylsilane
- Test material form:
- solid: crystalline
Constituent 1
Method
- Target gene:
- histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 3160 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethylene glycol dimethylether
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 (without activation) 10µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 (without activation) 10 µg/plate
- 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) 100 µg/plate
- 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) 1300 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthracene amide
- Remarks:
- TA 98, TA 102, TA 1537 (with activation) 2 µg/plate
- 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) 1500 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration. The experiment was repeated using the pre-incubation method
DETERMINATION OF CYTOTOXICITY
- Method: other: background lawn assessment
METABOLIC ACTIVATION
S9 was prepared from Aroclor 1254 induce rats, and checked for protein content and P-450 content. S9 mix contained 5% S9; 2% 0.4 M MgCl2/1.65 M KCl solution; glucose-6-phosphate and NADP as co-factors. 0.5 ml of S9 mix was added to 2 ml of top agar, 0.1 ml test material (or control) and 0.1 ml cell suspension, giving a final concentration of approximately 1% S9. - Evaluation criteria:
- A result is positive if the number of revertants is significantly increased compared with the solvent control to at least 2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both experiments.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking on histidine-free agar plates.
Cytotoxicity is defined as a reduction in the number of colonies by >50% compared with the solvent control and/or a sparse background lawn. - Statistics:
- MANN and WHITNEY and Spearman’s rank.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation was observed.
Any other information on results incl. tables
Table 2: Dose range-finding study Number of revertants per plate (TA 100 - MA)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
160 |
134 |
No |
0.316 |
152 |
196 |
No |
1 |
152 |
172 |
No |
3.16 |
141 |
150 |
No |
10 |
143 |
162 |
No |
31.6 |
157 |
135 |
No |
100 |
143 |
151 |
No |
316 |
155 |
162 |
No |
1000 |
181 |
144 |
No |
3160 |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
*solvent control with Ethylene glycol dimethylether
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
36 |
36.7 |
No |
151 |
134.3 |
No |
268.7 |
278.7 |
No |
31.6 |
35 |
35 |
No |
143 |
159 |
No |
268.3 |
274.7 |
No |
100 |
32 |
36 |
No |
134.7 |
158.7 |
No |
286.3 |
282 |
No |
316 |
37.3 |
37.3 |
No |
140.7 |
169.3 |
No |
290 |
283 |
No |
1000 |
30.7 |
37.3 |
No |
149 |
136.3 |
No |
288 |
270 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
284.7 |
265.3 |
No |
Positive control |
1291 |
845.7 |
No |
1243 |
1266.3 |
No |
1310 |
1228 |
No |
*solvent control with Ethylene glycol dimethylether
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
18.3 |
16.7 |
No |
6 |
4.3 |
No |
31.6 |
19.3 |
16 |
No |
3.7 |
5.3 |
No |
100 |
12.3 |
15.3 |
No |
4 |
4.3 |
No |
316 |
20.3 |
15.3 |
No |
5.3 |
4.3 |
No |
1000 |
18 |
13 |
No |
4.7 |
5 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
964.3 |
970 |
No |
360.7 |
383.7 |
No |
*solvent control with Ethylene glycol dimethylether
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
34.7 |
29 |
No |
131 |
132.3 |
No |
269.7 |
266.3 |
No |
31.6 |
31.3 |
27.3 |
No |
130.7 |
133.3 |
No |
258.7 |
267 |
No |
100 |
31.7 |
29 |
No |
128 |
131.7 |
No |
283.3 |
282.3 |
No |
316 |
38.3 |
27.3 |
No |
122.7 |
118.7 |
No |
259.7 |
278.3 |
No |
1000 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
1238 |
1238.7 |
No |
1349.3 |
1351 |
No |
1317 |
1216.3 |
No |
*solvent control with Ethylene glycol dimethylether
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
16 |
14.3 |
No |
13 |
14 |
No |
31.6 |
12.3 |
15.3 |
No |
12.7 |
14 |
No |
100 |
13.3 |
15.3 |
No |
9.3 |
13.3 |
No |
316 |
12 |
11.3 |
No |
7 |
11 |
No |
1000 |
0 |
0 |
Yes |
0 |
0 |
Yes |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
1354.7 |
1341.7 |
No |
1337.7 |
1330.7 |
No |
*solvent control with Ethylene glycol dimethylether
Applicant's summary and conclusion
- Conclusions:
- tert-Butyl(chloro)dimethylsilane has been tested in a reliable test conducted in accordance with OECD 471 (1997) and in compliance with GLP, using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102. No test-substance induced increase in the number of revertants was observed with or without metabolic activation up to cytotoxic concentrations in either the initial plate incorporation assay or the independent repeat experiment using the pre-incubation method. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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