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EC number: 201-081-7 | CAS number: 78-08-0
- 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
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:
- 15 Aug 2001 to 01 Mar 2002
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triethoxy(vinyl)silane
- EC Number:
- 201-081-7
- EC Name:
- Triethoxy(vinyl)silane
- Cas Number:
- 78-08-0
- Molecular formula:
- C8H18O3Si
- IUPAC Name:
- triethoxy(vinyl)silane
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains) and trp operon (for E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary toxicity study: 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, and 5000 µg/plate
Mutagenicity test, main study (with and without activation): 50, 150, 500, 1500, and 5000 µg/plate - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene (2-AA; +S9, 1 µg/plate for TA 100; 2 µg/plate for TA 1535, TA 1537; 10 µg/plate for WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates per experiment, 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: growth of background lawn - Evaluation criteria:
- The spontaneous reversion for the solvent control should be within historical control data. The positive controls should demonstrate that the test systems are responsive to known mutagens (induction of at least twice the respective vehicle control).
Positive reaction:
- number of revertants is statistically significantly increased compared to the solvent control in at least one strain
- the increase is reproducible and there is evidence of a dose-response relationship - Statistics:
- Dunnett´s method of linear regression (for assessment of dose-response relationship)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: No toxicity was observed in the preliminary toxicity test in TA 100 and WP2 uvrA with and without metabolic activation up to the maximum concentration of 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: negative control data were within historical control values
Precipitates: No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
Any other information on results incl. tables
Table 1: Results of the first experiment with and without metabolic activation.
With or without S9-Mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
TA 98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
||
– |
0 |
23±5 |
77±7 |
13±1 |
7±2 |
20±1 |
– |
50 |
15±1 |
81±7 |
12±6 |
6±5 |
17±4 |
– |
150 |
16±2 |
87±2 |
12±6 |
9±2 |
19±6 |
– |
500 |
14±3 |
85±10 |
14±1 |
8±1 |
13±3 |
– |
1500 |
21±3 |
88±15 |
12±3 |
12±3 |
18±4 |
– |
5000 |
24±5 |
88±5 |
17±4 |
8±2 |
18±6 |
Positive controls, –S9 |
Name |
4-NQO |
ENNG |
ENNG |
9-AA |
ENNG |
Concentrations (µg/plate) |
0.2 |
3 |
5 |
80 |
2 |
|
Revertants per plate |
91±9 |
439±29 |
221±22 |
2741±121 |
356±28 |
|
+ |
0 |
25±1 |
82±12 |
10±2 |
9±2 |
23±3 |
+ |
50 |
24±5 |
85±9 |
10±4 |
13±6 |
18±4 |
+ |
150 |
26±4 |
81±3 |
11±5 |
13±1 |
26±9 |
+ |
500 |
22±7 |
77±9 |
12±2 |
13±3 |
20±1 |
+ |
1500 |
23±2 |
88±8 |
10±3 |
11±4 |
19±3 |
+ |
5000 |
24±7 |
91±10 |
11±3 |
11±5 |
24±6 |
Positive controls, +S9 |
Name |
BP |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (µg/plate) |
5 |
1 |
2 |
2 |
10 |
|
Revertants per plate |
206±12 |
825±65 |
235±7 |
284±11 |
801±20 |
Table 2: Results of the second experiment with and without metabolic activation.
With or without S9-Mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
TA 98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
||
– |
0 |
17±3 |
95±12 |
15±6 |
9±6 |
19±5 |
– |
50 |
22±2 |
109±10 |
13±5 |
7±4 |
19±4 |
– |
150 |
15±4 |
88±6 |
18±6 |
9±4 |
18±3 |
– |
500 |
23±5 |
95±2 |
14±3 |
9±1 |
18±2 |
– |
1500 |
20±8 |
104±3 |
23±5 |
8±1 |
22±5 |
– |
5000 |
24±9 |
104±2 |
17±7 |
8±2 |
21±3 |
Positive controls, –S9 |
Name |
4-NQO |
ENNG |
ENNG |
9-AA |
ENNG |
Concentrations (µg/plate) |
0.2 |
3 |
5 |
80 |
2 |
|
Revertants per plate |
160±11 |
104±2 |
187±19 |
8±2 |
21±3 |
|
+ |
0 |
29±6 |
111±4 |
18±7 |
9±4 |
22±5 |
+ |
50 |
26±4 |
102±5 |
22±4 |
6±1 |
17±3 |
+ |
150 |
33±5 |
105±15 |
14±3 |
9±4 |
22±4 |
+ |
500 |
36±6 |
112±8 |
18±2 |
7±3 |
24±6 |
+ |
1500 |
25±8 |
103±7 |
20±6 |
7±1 |
19±4 |
+ |
5000 |
30±7 |
112±9 |
22±6 |
10±2 |
23± |
Positive controls, +S9 |
Name |
BP |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (µg/plate) |
5 |
1 |
2 |
2 |
10 |
|
Revertants per plate |
466±28 |
1152±67 |
408±28 |
536±26 |
909±177 |
4-NQO: 4-Nitroquinoline-1-oxide
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
9-AA: 9-Aminoacridine
2 -AA: 2 -Aminoanthracene
BP: Benzo(a)pyrene
Applicant's summary and conclusion
- Conclusions:
- Under test conditions, no mutagenic effect was observed for the test substance tested up to cytotoxic concentration in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic in test strains used.
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