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EC number: 210-535-3 | CAS number: 617-86-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-03-04 to 2002-09-13
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC directive 92/69/EEC (Methods for the Determination of Toxicity-Mutagenicity.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline S2A (Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline S2B (A Standard Battery for Genotoxicity Testing of Pharmaceuticals)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triethylsilane
- EC Number:
- 210-535-3
- EC Name:
- Triethylsilane
- Cas Number:
- 617-86-7
- Molecular formula:
- C6H16Si
- IUPAC Name:
- triethylsilane
- Test material form:
- liquid
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:
- 10, 31.6, 100, 316, 1000 µg/plate: all strains, with and without metabolic activation, plate incorporation test and preincubation test
1, 3.16 µg/plate: preincubation test, strain TA1537, with metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Abs. ethylene glycol dimethylether
- Justification for choice of solvent/vehicle: Solubility properties and relative nontoxicity to 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, 10 µg/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
ACTIVATION: Aroclor induced rat liver S9
S9 mix components (per 100 mL):
- 5.0 mL rat liver s9
- 2.0 mL 0.4 M MgCl2 + 1.65 M KCl-salt solution (sterile stock solution)
- 141.0 mg glucose-6-phosphate
- 306.5 mg NADP
- 50.0 mL 0.2 M phosphate buffer, pH 7.4 (sterile stock solution)
- sterile water for injection to 100 mL
DURATION:
-Plate incorporation: 48 hours at 37°C
-Preincubation 60 minutes at 37°C
- Preincubation period: 60minutes
- Exposure duration: 24hours
- Expression time (cells in growth medium): 24hours
NUMBER OF REPLICATIONS: 3 plates per concentration and experiment
SELECTION AGENT: histidine-deficient agar
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Evaluation criteria:
- A test chemical is considered to be show a positive response 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 independent experiments.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples in histidine free agar plates - Statistics:
- Mann Whitney U test and Spearman's rank correlation.
Results and discussion
Test results
- Key result
- 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:
- reduction in background lawn was observed at 1000 µg/plate with strain TA 100 in the plate incorporation assay, and from 100 µg/plate in the pre-incubation experiment.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Controls were within range of historical data.
Any other information on results incl. tables
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
solvent control |
155 |
136 |
no |
0.316 |
151 |
157 |
no |
1 |
145 |
128 |
no |
3.16 |
144 |
159 |
no |
10 |
155 |
146 |
no |
31.6 |
127 |
157 |
no |
100 |
149 |
151 |
no |
316 |
155 |
182 |
no |
1000 |
154 |
144 |
yes |
3160 |
0 |
0 |
yes |
5000 |
0 |
0 |
yes |
Preincubation: number of revertants per plate (mean of 3 plates)
Conc(µg/plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
Solvent control |
30.7 |
42.3 |
137.0 |
136.0 |
285.3 |
281.0 |
15.0 |
16.0 |
5.3 |
3.3 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
3.0 |
3.16 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
3.0 |
10 |
38.7 |
42.7 |
119.7 |
144.3 |
282.3 |
263.3 |
14.7 |
15.0 |
5.3 |
5.0 |
31.6 |
32.7 |
43.0 |
127.7 |
121.7 |
285.7 |
270.3 |
13.0 |
17.7 |
4.0 |
2.3 |
100 |
35.0* |
45.3* |
142.7* |
135.0* |
274.0* |
301.7 |
11.0* |
13.3 |
3.7* |
4.3* |
316 |
37.3* |
41.7* |
138.3* |
124.7* |
260.3* |
261.0* |
14.7* |
15.0* |
4.7* |
5.0* |
1000 |
0.0* |
0.0* |
129.3* |
136.0* |
255.3* |
277.0* |
16.3* |
16.7* |
4.7* |
3.7* |
Positive control |
1270.3 |
1266.0 |
1375.7 |
1379.7 |
1277.0 |
1373.3 |
1384.0 |
1376.7 |
844.3 |
420.3 |
*cytotoxic
Plate incorporation:number of revertants per plate (mean of 3 plates)
Conc(µg/plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
Solvent control |
38.3 |
45.3 |
116.7 |
134.0 |
289.3 |
272.3 |
22.3 |
17.3 |
5.3 |
5.7 |
10 |
35.7 |
43.0 |
129.7 |
131.0 |
303.0 |
276.0 |
14.0 |
21.3 |
4.3 |
6.0 |
31.6 |
37.7 |
47.7 |
129.0 |
139.3 |
276.3 |
269.0 |
14.3 |
18.7 |
3.0 |
3.3 |
100 |
38.7 |
38.7 |
132.0 |
118.3 |
279.3 |
290.3 |
16.7 |
20.3 |
4.3 |
3.7 |
316 |
41.3 |
41.0 |
121.0 |
140.3 |
261.0 |
271.7 |
19.3 |
20.3 |
2.7 |
5.0 |
1000 |
37.0 |
45.3 |
117.3* |
126.3* |
272.0 |
284.3 |
17.3 |
20.7 |
4.7 |
6.3 |
Positive control |
1173.7 |
1163.3 |
1186.7 |
1196.0 |
1329.7 |
1300.7 |
657.7 |
667.7 |
623.7 |
718.3 |
*cytotoxic
Applicant's summary and conclusion
- Conclusions:
- Triethylsilane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471 and in compliance with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 or TA 1537 in the initial plate incorporation assay or the repeat experiment using the pre-incubation method up to cytotoxic concentrations. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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