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EC number: 262-061-1 | CAS number: 60111-54-8
- 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:
- 25.08.2011 - 15.09.2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Kanpoan No.287
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane
- EC Number:
- 262-061-1
- EC Name:
- 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane
- Cas Number:
- 60111-54-8
- Molecular formula:
- C16H36O4Si5
- IUPAC Name:
- tetraethenyldimethylsilyl silicate
- Reference substance name:
- 060111-54-8
- Cas Number:
- 060111-54-8
- IUPAC Name:
- 060111-54-8
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitol/beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: the solvent was requested by the sponsor.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA100 without metabolic activation 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine 10 µg/plate TA98 and 50 µg/plate TA1537
- Remarks:
- TA1537, TA98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without metabolic activation 3 µl/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 2.5 µg/plate TA1535, TA1537, TA98, TA100 and 10 µg/plate WP2 uvrA
- Remarks:
- TA1535, TA1537, TA98, TA100, WP2 uvrA with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
ACTIVATION: S9 mix contained glucose-6-phosphate and NADP as co-factors. The amount of S9 supernatant was 10% v/v in the S9 mix. 0.5 ml S9 was added to test solution, bacterial suspension and top agar giving a final concentration in the cultures of approximately 2% S9.
DURATION
- Preincubation period: 60 minutes at 37C
- Exposure duration: 72 hours
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates, pre-experiment for toxicity and experiment 1 used plate incorporation, the test was repeated using pre-incubation.
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the mean number of revertant colonies exceeding the threshold of twice (strains TA98, TA100 and WP2 uvrA) or thrice (strains TA1535 and TA1537) the mean colony count of the corresponding solvent control is observed. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
- Statistics:
- No statistical evaluation of the data was required.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxicity was not evident at any concentrations
Any other information on results incl. tables
Table 1: Experiment 1 - Mean revertant colony counts
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|||||
Concentration (µg/plate) |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Solvent control |
14 |
21 |
15 |
25 |
33 |
38 |
126 |
130 |
47 |
49 |
Negative control |
16 |
17 |
17 |
21 |
37 |
54 |
120 |
127 |
44 |
49 |
3 |
12 |
21 |
16 |
24 |
32 |
41 |
123 |
120 |
52 |
49 |
10 |
13 |
18 |
14 |
24 |
34 |
37 |
117 |
131 |
40 |
56 |
33 |
15 |
21 |
18 |
21 |
36 |
37 |
129 |
105 |
44 |
49 |
100 |
13 |
24 |
16 |
24 |
39 |
39 |
139 |
131 |
40 |
53 |
333 |
15 |
18 |
18 |
19 |
38 |
29 |
134 |
134 |
47 |
48 |
1000 |
14 |
16 |
16 |
15 |
38 |
23 |
142 |
135 |
51 |
46 |
2500 |
18 |
17 |
18 |
16 |
38 |
23 |
127 |
124 |
45 |
44 |
5000 |
14 |
18 |
17 |
15 |
29 |
18 |
129 |
119 |
39 |
31 |
Positive control |
1536 |
313 |
71 |
388 |
326 |
1266 |
1791 |
2270 |
956 |
227 |
Table 2: Experiment 2 Mean revertant colony counts
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|||||
Concentration (µg/plate) |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Solvent control |
16 |
21 |
22 |
26 |
37 |
37 |
132 |
139 |
49 |
63 |
Negative control |
18 |
16 |
24 |
28 |
41 |
45 |
142 |
143 |
52 |
64 |
3 |
NA |
19 |
NA |
26 |
NA |
41 |
NA |
159 |
NA |
58 |
10 |
NA |
21 |
NA |
24 |
NA |
39 |
NA |
162 |
NA |
55 |
33 |
18 |
24 |
21 |
26 |
31 |
44 |
124 |
124 |
50 |
61 |
100 |
16 |
21 |
24 |
30 |
33 |
40 |
140 |
161 |
58 |
53 |
333 |
17 |
18 |
24 |
19 |
37 |
35 |
134 |
150 |
51 |
53 |
1000 |
17 |
15 |
21 |
19 |
33 |
29 |
155 |
145 |
58 |
58 |
2500 |
15 |
16 |
20 |
17 |
30 |
31 |
156 |
127 |
56 |
37 |
5000 |
17 |
16 |
24 |
16 |
38 |
29 |
155 |
114 |
57 |
42 |
Positive control |
1780 |
318 |
118 |
266 |
329 |
1655 |
1782 |
1602 |
643 |
261 |
Applicant's summary and conclusion
- Conclusions:
- 3,3-Bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane has been tested for mutagenicity to bacteria, in a study which was conducted according to OECD Test Guideline 471 and in compliance with GLP. No evidence of a test substance related increase in the number of revertant colonies was observed with or without metabolic activation in the pre-experiment for toxicity or the initial assay using the plate incorporation method using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2. The result was confirmed the repeat preincubation experiment. Appropriate positive, negative and solvent controls were included and gave 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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