Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-099-6 | CAS number: 2627-95-4
- 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:
- 1992-09-21 - 1992-11-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The restrictions are that the only positive control used with metabolic activation was 2-aminoanthracene.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US EPA Standards 40 CFR 792 and 340 CFR 160
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- the only positive control used with metabolic activation was 2-aminoanthracene
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,3,3-tetramethyl-1,3-divinyldisiloxane
- EC Number:
- 220-099-6
- EC Name:
- 1,1,3,3-tetramethyl-1,3-divinyldisiloxane
- Cas Number:
- 2627-95-4
- Molecular formula:
- C8H18OSi2
- IUPAC Name:
- ethenyl[(ethenyldimethylsilyl)oxy]dimethylsilane
- Reference substance name:
- 002627-95-4
- Cas Number:
- 002627-95-4
- IUPAC Name:
- 002627-95-4
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine operon (Salmonella) tryptophan operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 100, 333, 1000, 3333 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: the test article formed a solution in acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, all TA strains at 1.0 µg/plate, WP2 uvrA at 10 µg/plate
- Remarks:
- TA98, TA100, TA1535, TA1537, TA1538, WP2 uvrA with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without metabolic activation 75 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA1538 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without metabolic activation 1000 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
ACTIVATION: S9 mix contained 10% S9 and glucose-6-phosphate and NADP as co-factors. 500 µl of S9 mix was added to 2 ml top agar giving a final concentration of approximately 2% S9.
DURATION
- Exposure duration: 48 hours at 37+/- 2ºC
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn
OTHER: - Evaluation criteria:
- For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article. Data sets for strains TA1535, TA1537 and TA 1538 will be judged positive if the increase in mean revertants is equal to or greater than three times the mean vehicle control value. Data sets for strains TA98, TA100 and WP2 uvrA will be judged positive if the increase in mean revertants is equal to or greater than two times the mean vehicle control value.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Precipitate but no appreciable toxicity was observed
- 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
- Remarks:
- Precipitate but no appreciable toxicity was observed
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: occurred between 1000 and 5000 µg/plate, did not interfere with test.
RANGE-FINDING/SCREENING STUDIES:
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: cytotoxicity was not evident at any concentration
Any other information on results incl. tables
Summary of results – Experiment I Revertants per plate (mean of 3 plates)
Dose µg/ml |
+/- metabolic activation |
Average revertants per plate |
|||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1538 |
WP2 uvrA |
||
Solvent control |
- |
14 |
161 |
10 |
4 |
6 |
19 |
100 |
- |
17 |
151 |
7 |
5 |
7 |
14 |
333 |
- |
14 |
158 |
11 |
4 |
8 |
14 |
1000 |
- |
15 |
164 |
10 |
4 |
8 |
13 |
3333 |
- |
16 |
162 |
9 |
3 |
9 |
16 |
5000 |
- |
16 |
158 |
8 |
6 |
6 |
15 |
Positive control |
- |
195 |
707 |
355 |
224 |
279 |
150 |
Solvent control |
+ |
28 |
177 |
11 |
8 |
11 |
20 |
100 |
+ |
24 |
189 |
11 |
7 |
8 |
19 |
333 |
+ |
20 |
185 |
14 |
5 |
11 |
18 |
1000 |
+ |
21 |
186 |
8 |
8 |
14 |
18 |
3333 |
+ |
22 |
184 |
12 |
5 |
12 |
16 |
5000 |
+ |
26 |
174 |
10 |
7 |
13 |
11 |
Positive control |
+ |
1948 |
1269 |
37 |
39 |
228 |
374 |
Summary of results – Experiment II
Dose µg/ml |
+/- metabolic activation |
Average revertants per plate |
|||||
TA98 |
TA100 |
TA1535 |
TA1537 |
TA1538 |
WP2 uvrA |
||
Solvent control |
- |
11 |
123 |
6 |
5 |
7 |
15 |
100 |
- |
12 |
111 |
11 |
4 |
7 |
15 |
333 |
- |
8 |
113 |
5 |
4 |
5 |
12 |
1000 |
- |
14 |
120 |
7 |
4 |
6 |
10 |
3333 |
- |
9 |
121 |
10 |
4 |
5 |
15 |
5000 |
- |
15 |
151 |
12 |
5 |
8 |
10 |
Positive control |
- |
123 |
386 |
297 |
301 |
295 |
145 |
Solvent control |
+ |
19 |
137 |
14 |
4 |
13 |
20 |
100 |
+ |
18 |
139 |
12 |
7 |
10 |
15 |
333 |
+ |
19 |
144 |
7 |
6 |
14 |
19 |
1000 |
+ |
23 |
139 |
11 |
6 |
14 |
14 |
3333 |
+ |
20 |
143 |
10 |
6 |
7 |
10 |
5000 |
+ |
22 |
150 |
13 |
9 |
14 |
15 |
Positive control |
+ |
817 |
814 |
51 |
95 |
818 |
410 |
Applicant's summary and conclusion
- Conclusions:
- 1,1,3,3-Tetramethyl-1,3-divinyldisiloxane has been tested for mutagenicity to bacteria in a reliable study which was conducted according to a protocol that is equivalent to 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 the initial or the repeat experiments using Salmonella typhimurium strains TA 98, 100, 1535, 1537 and 1538, and E.coli WP2uvrA. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
