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: 203-497-4 | CAS number: 107-51-7
- 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:
- 2007-12-28 - 2008-01-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octamethyltrisiloxane
- EC Number:
- 203-497-4
- EC Name:
- Octamethyltrisiloxane
- Cas Number:
- 107-51-7
- Molecular formula:
- C8H24O2Si3
- IUPAC Name:
- 2,2,4,4,6,6-hexamethyl-3,5-dioxa-2,4,6-trisilaheptane
- Reference substance name:
- 105-51-7
- IUPAC Name:
- 105-51-7
Constituent 1
Constituent 2
Method
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:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: none given
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 1 µg/plate
- Remarks:
- TA98, TA100, TA1535 and TA1537 with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 10 µg/plate
- Remarks:
- 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 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 and TA1535 without metabolic activation: 1 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:
- 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. 0.5 ml S9 mix was added to 2.0 ml top agar giving a final concentration of approximately 2% S9.
DURATION
- Exposure duration: 48 - 72 hours
NUMBER OF REPLICATIONS: experiment 1 - duplicate plates, experiment 2 - triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn - Evaluation criteria:
- A result is positive if the mean of each positive control exhibits at least a 3-fold increase in the number of revertants over the mean value of the respective vehicle control. A minimum of three non-toxic dose levels were required to evaluate assay data. Strains TA1535 and TA1537 were judged positive if there was a 3-fold increase in the number of revertants compared with the mean vehicle control value and a 2-fold increase for Salmonella typhimurium strains TA98, TA100 and E. coli WP2 uvrA.
- Statistics:
- None stated in report
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:
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
COMPARISON WITH HISTORICAL CONTROL DATA: Historical negative and positive control values included in report
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxicity was not evident at any concentration
Any other information on results incl. tables
Plate incorporation – average number of revertants per plate (mean of 2 plates).
Experiment 1
Treatment µg/plate |
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Solvent control |
15 |
13 |
147 |
164 |
16 |
13 |
4 |
8 |
21 |
18 |
1.5 |
17 |
13 |
160 |
147 |
18 |
12 |
6 |
6 |
18 |
18 |
5.0 |
16 |
14 |
164 |
175 |
19 |
9 |
1 |
8 |
22 |
24 |
15 |
16 |
17 |
140 |
120 |
15 |
11 |
8 |
4 |
19 |
14 |
50 |
13 |
14 |
177 |
156 |
17 |
13 |
6 |
5 |
19 |
21 |
150 |
15 |
18 |
155 |
156 |
22 |
12 |
7 |
6 |
24 |
24 |
500 |
12 |
15 |
172 |
171 |
15 |
12 |
8 |
9 |
24 |
18 |
1500 |
14 |
17 |
149 |
153 |
11 |
7 |
4 |
9 |
23 |
20 |
5000 |
14 |
16 |
179 |
175 |
15 |
9 |
7 |
5 |
21 |
21 |
Positive control |
144 |
454 |
540 |
553 |
369 |
121 |
923 |
131 |
166 |
242 |
Plate incorporation – average number of revertants per plate (mean of 3 plates).
Experiment 2
Treatment µg/plate |
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Solvent control |
31 |
17 |
183 |
184 |
20 |
17 |
10 |
8 |
23 |
23 |
50 |
18 |
18 |
189 |
173 |
16 |
16 |
6 |
10 |
21 |
19 |
150 |
28 |
16 |
199 |
172 |
16 |
18 |
11 |
11 |
27 |
24 |
500 |
24 |
12 |
171 |
180 |
12 |
18 |
11 |
7 |
25 |
20 |
1500 |
26 |
17 |
189 |
193 |
18 |
16 |
6 |
10 |
22 |
25 |
5000 |
28 |
19 |
167 |
198 |
16 |
20 |
6 |
10 |
20 |
23 |
Positive control |
194 |
666 |
607 |
660 |
436 |
125 |
1154 |
185 |
127 |
278 |
Applicant's summary and conclusion
- Conclusions:
- Octamethyltrisiloxane has been tested for mutagenicity to bacteria in a study which was conducted according to OECD 471, and in compliance with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without activation in the initial or the repeat experiments with Salmonella typhimurium strains TA 98, 100, 1535, 1537 and E.coli WP2 uvrA. Appropriate positive and solvent controls were tested and gave expected results. 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.
