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EC number: 241-931-4 | CAS number: 18023-33-1
- 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:
- 13 Feb 2015 to 20 March 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- tris(isopropenyloxy)(vinyl)silane
- IUPAC Name:
- tris(isopropenyloxy)(vinyl)silane
- Reference substance name:
- Tris(isopropenyloxy)vinylsilane
- EC Number:
- 239-362-1
- EC Name:
- Tris(isopropenyloxy)vinylsilane
- Cas Number:
- 15332-99-7
- Molecular formula:
- C11H18O3Si
- Test material form:
- other: liquid
Constituent 1
Constituent 2
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:
- Phenobarbital and β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- pre-experiment: 0.00316, 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 μl/plate
main experiments: 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 μl/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: aqueous solvent was in appropriate due to the hydrolytic instability of the substance. The solvent was compatible with the survival of the bacteria and the S9 activity
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535; 10 μg/plate; -MA
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine (4-NOPD)
- Remarks:
- TA 98 (10 μg/plate), TA 1537 (40 μg/plate); -MA
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102; 1 μl/plate; -MA
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- all strains; 2.5 μg/plate (10 μg/plate for TA 102); +MA
- Details on test system and experimental conditions:
- ACTIVATION:
Phenobarbital and β-naphthoflavone induced rat liver S9
Protein concentration: 38.2 mg/ml adjusted to 25 mg/ml
S9 mix:
- 100 mM sodium-ortho-phosphate-buffer, pH7.4
- 8 mM MgCl2
- 22 mM KCl
- 5 mM glucose-6-phosphate
- 4 mM NADP
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min at 37°C
- Selection time (if incubation with a selection agent): at least 48h at 37°C in the dark
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS: 3 plates per concentration; the experiment was repeated. The initial assay was conducted using the plate incorporation method, the repeat experiment used pre-incubation.
DETERMINATION OF CYTOTOXICITY
- Method: other: clearing or diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤0.5 in relation to the solvent control
OTHER: - Evaluation criteria:
- A test item is considered mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is:
- if in strains TA 98, TA 100 & TA 102, the number of reversions is at least twice as high
- if in strains TA 1535 & TA 1537, the number of reversions is at least three times as high - Statistics:
- A statistical evaluation is not regarded as necessary.
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Plate incorporation - mean number of revertants (3 plates)
Dose (µl/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
Negative control |
16 |
25 |
69 |
96 |
9 |
9 |
6 |
6 |
246 |
287 |
Solvent control |
13 |
18 |
67 |
79 |
8 |
9 |
5 |
4 |
210 |
284 |
0.0316 |
17 |
22 |
65 |
85 |
13 |
11 |
7 |
7 |
193 |
275 |
0.100 |
18 |
19 |
61 |
74 |
11 |
13 |
6 |
6 |
201 |
281 |
0.316 |
16 |
22 |
57 |
80 |
11 |
9 |
7 |
4 |
206 |
270 |
1.0 |
14 |
26 |
53 |
87 |
10 |
11 |
5 |
3 |
204 |
292 |
2.5 |
20 |
27 |
64 |
88 |
9 |
8 |
7 |
4 |
204 |
291 |
5.0 |
20 |
26 |
70 |
93 |
14 |
8 |
5 |
6 |
220 |
286 |
Positive control |
326 |
2361 |
285 |
2424 |
846 |
182 |
66 |
211 |
2714 |
762 |
Table 2: Preincubation - mean number of revertants (3 plates)
Dose (µl/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
Negative control |
24 |
23 |
83 |
106 |
12 |
14 |
5 |
5 |
237 |
383 |
Solvent control |
19 |
22 |
65 |
88 |
12 |
13 |
4 |
4 |
162 |
277 |
0.0316 |
17 |
32 |
68 |
100 |
17 |
12 |
4 |
9 |
214 |
369 |
0.100 |
20 |
22 |
75 |
87 |
15 |
10 |
8 |
7 |
174 |
337 |
0.316 |
15 |
23 |
66 |
95 |
15 |
14 |
4 |
5 |
161 |
329 |
1.0 |
19 |
23 |
73 |
95 |
19 |
12 |
4 |
3 |
130 |
319 |
2.5 |
23 |
28 |
64 |
90 |
15 |
12 |
3 |
6 |
105 |
307 |
5.0 |
18 |
24 |
87 |
94 |
12 |
12 |
2 |
7 |
253 |
386 |
Positive control |
856 |
868 |
527 |
1598 |
1158 |
210 |
69 |
155 |
2094 |
725 |
Applicant's summary and conclusion
- Conclusions:
- Tris(isopropenyloxy)(vinyl)silane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, compliant 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 1535, TA 1537 or TA 102 in the initial plate incorporation assay or the repeat experiment using the pre-incubation method, up to limit concentrations. Appropriate positive, solvent and negative (water) 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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