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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse mutation assay / Ames test): negative
with and without activation in Salmonella typhimurium strains TA98,
TA100, TA1535 and TA1537 Escherichia coli WP2 (OECD TG 471) (Dow Corning
Corporation, 2011b).
Cytogenicity in mammalian cells: negative with and without activation in
cultured human lymphocytes (OECD TG 473) (Dow Corning Corporation,
2011c).
Mutagenicity in mammalian cells: negative with and without activation in
L5178Y mouse lymphoma cells (OECD TG 476) (Bioservice, 2012).
Link to relevant study records
- 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
- 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
- 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. - 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.
- 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 - 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.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-07-28 - 2011-09-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- lymphocytes: peripheral human lymphocytes
- Details on mammalian cell type (if applicable):
- Blood cultures were set up in bulk within 24 hours of collection in 75 cm flasks. Culture medium was DMEM:F12 ( Dulbeccos's modified eagle medium)/Hams F:12; mixed 1:1. Medium included 15mM HEPES and 200 mM L-glutamine. Also added was 10,000 U/ml penicillin and 10,000 µg/ml streptomycin, Phytohemagglutinin - 3 µg/ml, 10% FBS (foetal bovine serum), heparin 25,000 USP-U/ml. All incubations were at 37°C in humified atmosphere with 5.5% CO2.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 0.01, 0.02, 0.04, 0.08, 0.16, 0.3, 0.6, 1.3, 2.5 and 5.0 µl/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: Solvent chosen due to its solubility properties and its relative non-toxicity to the cell cultures. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation exp 1: 825 µg/ml exp 2: 660 µg/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation exp 1 and 2: 7.5 µg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
ACTIVATION: S9 mix contained glucose-6-phosphate and NADP as co-factors
DURATION
- Exposure duration: Exp 1 - 4 hours with and without S9. Exp 2 - 4 hours with S9 mix and 22 hours without S9
- Expression time (cells in growth medium):94 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 22 hours
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: duplicate flasks, test repeated
NUMBER OF CELLS EVALUATED: 200 metaphases scored for chromosome aberrations per dose group, 2000 cells per dose group were counted for determination of the mitotic index.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: no - Evaluation criteria:
- The test item is classified as mutagenic if the number of induced structural chromosome aberrations is not within the range of the historical control data and a concentration related increase or a significant increase in the number of structural chromosome aberrations is observed.
- Statistics:
- Fisher's exact test
- Key result
- Species / strain:
- lymphocytes: peripheral human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no relevant influence was observed
- Effects of osmolality: slightly decreased at the highest concentration
- Precipitation: none observed
COMPARISON WITH HISTORICAL CONTROL DATA: aberration rates of cells after treatment were close to the range of the solvent control values and within the range of the historical data - Conclusions:
- 3,3-Bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane has been tested in an in vitro chromosome aberration assay in peripheral human lymphocytes, conducted according to OECD Test Guideline 473 and in compliance with GLP. No evidence of a test substance related increase in chromosome aberrations was observed with or without metabolic activation in the initial or the repeat experiment. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for cytogenicity under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-11-08 to 2012-01-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: IWGT Recommendations
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and ß-Naphthoflavone-induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-expt I: 0.1, 0.5, 2.5, 5.0, 7.5 and 10.0 mM (+/-S9); Pre-expt II: 2.5, 5.0, 7.5 and 10.0 mM (24 h -S9);
Expt I: 0.5, 1.0, 2.0, 4.0, 5.0, 7.0, 8.0 and 10.0 mM (+S9), 0.25, 1.0, 2.0, 4.0, 7.0, 8.0, 9.0 and 10.0 mM (-S9);
Expt II: 0.75, 1.5, 3.5, 6.5, 7.5, 8.5, 9.5 and 10.0 mM (+S9), 0.1, 0.5, 1.0, 2.0, 4.0, 7.0, 9.0 and 10.0 mM (-S9) - Vehicle / solvent:
- The test item was soluble in acetone (final concentration of 0.5% solvent v/v).
The solvent was compatible with the survival of the cells of the S9 activity. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation 2.5 µg/mL
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation 200 µg/mL and 300 µg/mL
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation 10 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: suspended / dissolved in medium
DURATION: 4 h (short-term exposure), 24 h (long-term exposure)
Expression time (cells in growth medium): 48 h
Selection time (if incubation with selection agent): about 14 days
SELECTION AGENT ( mutation assay) 5 µg/mL trifluorothymidine
NUMBER OF REPLICATIONS: two separate experiments (I+II) with single exposure; cells were seeded in 4 plates and evaluated
NUMBER OF CELLS SEEDED: 2000 cells per well
DETERMINATION OF CYTOTOXICITY: relative total growth (RTG)
METABOLIC ACTIVATION: S9 mix included glucose-6-phosphate and NADP, and sufficient S9 to give a protein concentration of 0.75 mg/ml in the cultures. - Evaluation criteria:
- The test item is considered mutagenic if following criteria are met:
-The induced mutant frequency meets or exceeds the Global Evaluation factor (GEF) of 126 per 10^6 cells
- A dose-dependent increase in mutant frequency is detected.
Besides, combined with a positive effect in the mutant frequency, an increased occurrence of small colonies (≥40% of total colonies) is an indication for potential clastogenic effects and/or chromosomal aberrations.
According to the OECD guideline, the biological relevance is considered first for the interpretation of results. Statistical methods might be used as an aid in evaluation the test result.
A test item is considered to be negative if the induced mutant frequency is below the GEF and the trend test is negative. - Statistics:
- The non-parametric Mann-Whitney test is applied to the mutation data to prove the dose groups for any significant difference in mutant frequency compared to the negative /solvent controls.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Tetra(dimethylvinylsiloxy)silane (3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane) has been tested for mutagenicity to mammalian cells in a reliable study conducted according to OECD 476 and in compliance with GLP. No evidence for a test-substance induced increase in mutant frequency was observed with or without activation when the substance was tested in mouse lymphoma L5178Y cells up to limit concentrations. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the condition of the study.
Referenceopen allclose all
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 |
Summary of results from Experiments I and II with and without metabolic activation
Experiment |
Preparation interval (hrs) |
Dose level µl/ml |
% Polyploid cells |
MI* in % of control |
% Aberrant cells |
||
Incl gaps |
Excl gaps |
With exchanges |
|||||
Exposure period 4 hours without S9 mix |
|||||||
I |
22 |
Solvent control |
0.2 |
100.00 |
1.5 |
1.0 |
0.0 |
Positive control |
- |
116.4* |
13.0 |
10.0 |
1.0 |
||
0.3 |
0.0 |
116.4 |
0.5 |
0.5 |
0.0 |
||
1.3 PS |
0.0 |
82.5 |
1.0 |
0.5 |
0.0 |
||
2.5 PS |
0.0 |
98.8 |
3.0 |
2.5 |
0.5 |
||
5.0 PS |
0.0 |
84.2 |
1.0 |
1.0 |
0.0 |
||
Exposure period 22 hours without S9 mix |
|||||||
II |
22 |
Solvent control |
0.0 |
100.0 |
2.5 |
2.0 |
0.5 |
Positive control |
- |
51.5 |
13.5 |
12.5 |
1.5 |
||
0.3 |
0.0 |
97.5 |
1.0 |
1.0 |
0.0 |
||
1.3 PS |
0.4 |
92.8 |
0.5 |
0.5 |
0.0 |
||
2.5 PS |
0.2 |
92.0 |
1.5 |
1.5 |
0.0 |
||
5.0 PS |
0.0 |
89.9 |
0.0 |
0.0 |
0.0 |
||
Exposure period 4 hours with S9 mix |
|||||||
I |
22 |
Solvent control |
0.0 |
100.0 |
0.5 |
0.5 |
0.0 |
Positive control |
- |
65.9 |
10.0 |
8.5 |
0.5 |
||
0.3 |
0.2 |
87.0 |
1.5 |
1.0 |
0.0 |
||
1.3 PS |
0.0 |
86.2 |
1.0 |
0.5 |
0.0 |
||
2.5 PS |
0.2 |
91.3 |
1.5 |
1.5 |
0.0 |
||
5.0 PS |
0.2 |
97.8 |
2.0 |
2.0 |
0.0 |
||
Exposure period 4 hours with S9 mix |
|||||||
II |
22 |
Solvent control |
0.0 |
100.0 |
2.5 |
2.5 |
0.0 |
Positive control |
- |
46.8 |
16.5 |
16.5 |
2.0 |
||
0.3 |
0.0 |
98.2 |
2.0 |
1.5 |
0.5 |
||
1.3 PS |
0.4 |
80.1 |
1.0 |
1.0 |
0.0 |
||
2.5 PS |
0.2 |
100.0 |
0.5 |
0.5 |
0.0 |
||
5.0 PS |
0.0 |
111.7 |
0.5 |
0.5 |
0.0 |
MI = mitotic indices
PS = Phase separation was observed
* It is noted by the reviewer that this positive control does not exhibit mitotic inhibition, and that the value is the same as that for the lowest test concentration in the row below.
Pre-experiment toxicity with and without metabolic activation
Concentration (mM) |
Number of cells 4 h after treatment |
Number of cells 24 h after treatment |
Number of cells 48 h after treatment |
SGa |
RSGb (%) |
|||||
|
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
Negative control |
315000 |
308000 |
1050000 |
500000 |
1280000 |
226000 |
13.4 |
11.3 |
82.2 |
94.0 |
Negative control |
328000 |
294000 |
966000 |
513000 |
1600000 |
223000 |
15.5 |
11.4 |
94.5 |
95.2 |
Solvent control |
311000 |
309000 |
9850000 |
658000 |
1630000 |
179000 |
16.1 |
11.8 |
100.0 |
100.0 |
Solvent control |
328000 |
329000 |
1010000 |
632000 |
1650000 |
194000 |
16.7 |
12.3 |
||
0.1 |
290000 |
249000 |
1050000 |
697000 |
1370000 |
171000 |
17.8 |
11.9 |
108.9 |
99.2 |
0.5 |
327000 |
290000 |
1050000 |
821000 |
1510000 |
170000 |
15.9 |
14.0 |
96.9 |
116.1 |
2.5 (P) |
217000 |
209000 |
747000 |
491000 |
1640000 |
198000 |
12.3 |
9.7 |
74.9 |
80.9 |
5.0 (P) |
217000 |
236000 |
742000 |
670000 |
1620000 |
177000 |
12.0 |
11.9 |
73.5 |
98.7 |
7.5 (P) |
253000 |
228000 |
865000 |
860000 |
1480000 |
160000 |
12.8 |
13.8 |
78.3 |
114.5 |
10.0(P) |
244000 |
231000 |
761000 |
830000 |
1500000 |
159000 |
11.4 |
13.2 |
69.8 |
109.8 |
P = precipitation SG = suspension growth RSG = relative suspension growth
Summary: Experiment I and II with and without metabolic activation
Treatment (mM) |
RTG (%) |
MF (mutants/106cells |
IMF (mutants/106cells) |
Precipitate |
||||
Experiment 1 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Negative control |
79.6 |
90.7 |
132.8 |
117.1** |
/ |
/ |
- |
- |
Negative control |
110.3 |
188.2* |
/ |
/ |
- |
- |
||
Solvent control |
100.0 |
100.0 |
134.5 |
96.8 |
/ |
/ |
- |
- |
Solvent control |
/ |
/ |
- |
- |
||||
0.25 |
75.5 |
na |
129.5 |
na |
-5.0 |
na |
- |
na |
0.5 |
na |
118.2 |
na |
125.8 |
na |
29.0 |
na |
- |
1.0 |
89.4 |
104.4 |
135.6 |
83.7 |
1.1 |
-13.2 |
+ |
+ |
2.0 |
89.4 |
96.5 |
182.4 |
86.2 |
47.9 |
-10.6 |
+ |
+ |
4.0 |
85.0 |
83.1 |
118.2 |
121.0 |
-16.3 |
24.1 |
+ |
+ |
5.0 |
na |
78.9 |
na |
93.7 |
na |
-3.1 |
na |
+ |
7.0 |
97.0 |
72.4 |
155.7 |
103.0 |
21.2 |
6.2 |
+ |
+ |
8.0 |
108.6 |
77.7 |
154.2 |
110.9 |
19.7 |
14.1 |
+ |
+ |
9.0 |
85.5 |
na |
158.2 |
na |
23.7 |
na |
+ |
Na |
10.0 |
74.4 |
84.0 |
174.2 |
102.7 |
39.7 |
5.8 |
+ |
+ |
Positive control 1 |
74.2 |
52.1 |
612.2 |
477.4 |
477.7 |
380.6 |
- |
- |
Positive control 2 |
67.4 |
na |
438.5 |
na |
304.0 |
na |
- |
na |
|
|
|
|
|
|
|
|
|
Experiment 2 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Negative control |
121.7 |
100.5 |
73.0 |
70.2 |
/ |
/ |
- |
- |
Negative control |
132.5 |
75.2 |
/ |
/ |
- |
- |
||
Solvent control |
100.0 |
100.0 |
73.3 |
80.8 |
/ |
/ |
- |
- |
Solvent control |
/ |
/ |
- |
- |
||||
0.1 |
119.7 |
na |
85.0 |
na |
11.7 |
na |
- |
na |
0.5 |
132.2 |
na |
78.7 |
na |
5.4 |
na |
- |
na |
0.75 |
na |
86.1 |
na |
60.9 |
na |
-19.9 |
na |
- |
1.0 |
117.1 |
na |
84.8 |
na |
11.5 |
na |
+ |
na |
1.5 |
na |
67.0 |
na |
91.4 |
na |
10.6 |
na |
- |
2.0 |
97.9 |
na |
72.9 |
na |
-0.4 |
na |
+ |
na |
3.5 |
na |
99.7 |
na |
65.5 |
na |
-15.3 |
na |
+ |
4.0 |
134.5 |
na |
68.3 |
na |
-5.1 |
na |
+ |
na |
6.5 |
na |
52.3 |
na |
64.2 |
na |
-16.6 |
na |
+ |
7.0 |
134.0 |
na |
64.9 |
na |
-8.4 |
na |
+ |
na |
7.5 |
na |
62.9 |
na |
81.1 |
na |
0.3 |
na |
+ |
8.5 |
na |
79.5 |
na |
62.4 |
na |
-18.4 |
na |
+ |
9.0 |
134.8 |
na |
79.7 |
na |
6.3 |
na |
+ |
na |
9.5 |
na |
60.6 |
na |
56.0 |
na |
-24.8 |
na |
+ |
10.0 |
148.5 |
59.0 |
77.1 |
65.7 |
3.8 |
-15.1 |
+ |
+ |
Positive control 1 |
27.2 |
53.4 |
1873.4 |
544.2 |
1800.1 |
463.4 |
- |
- |
Positive control 2 |
129.5 |
na |
418.3 |
na |
344.9 |
na |
- |
na |
None of the test substance mutation frequencies exceed GEF (global evaluation factor). Positive control results exceed GEF and were statistically significant: test substance results did not exceed GEF and were not statistically significant. na: these concentrations were not tested.
*Outlier, excluded from evaluation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data are available from reliable studies for all the required in vitro endpoints. The results of all the studies are in agreement.
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 (Dow Corning Corporation, 2011b). 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. The result was confirmed in the repeat preincubation experiment. The bacteria used were S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2. 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.
3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane has been tested in an in vitro chromosome aberration assay in peripheral human lymphocytes, conducted according to OECD Test Guideline 473 and in compliance with GLP (Dow Corning Corporation, 2011c). No evidence of a test substance related increase in chromosome aberrations was observed with or without metabolic activation in the initial or the repeat experiment. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for cytogenicity under the conditions of the test.
Information on the mutagenicity of 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane to mammalian cells is available from a reliable study conducted according to OECD Test Guideline 476 and in compliance with GLP (Bioservice, 2012). No evidence for a test-substance induced increase in mutant frequency was observed with or without activation when the substance was tested in mouse lymphoma L5178Y cells up to limit concentrations. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the condition of the study.
In vivo testing is not required as no evidence for genetic toxicity was found in the in vitro studies.
Justification for classification or non-classification
Based on the available in vitro genotoxicity data, 3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane is not classified for mutagenicity according to Regulation (EC) No 1272/2008.
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