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EC number: 203-499-5 | CAS number: 107-52-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 September 2014 to 03 November 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21st July 1997
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- other: EC No. 440/2008 B.13/14:"Mutagenicity - Reverse Mutation Test using Bacteria"
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetradecamethylhexasiloxane
- EC Number:
- 203-499-5
- EC Name:
- Tetradecamethylhexasiloxane
- Cas Number:
- 107-52-8
- Molecular formula:
- C14H42O5Si6
- IUPAC Name:
- 2,2,4,4,6,6,8,8,10,10,12,12-dodecamethyl-3,5,7,9,11-pentaoxa-2,4,6,8,10,12-hexasilatridecane
Constituent 1
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 (80 mg/kg bw) and β-naphthoflavone (100 mg/kg bw) induced rat liver S9
- Test concentrations with justification for top dose:
- 0.0316, 0.100, 0.316, 1.0, 2.5, 5.0 µL/plate
- Vehicle / solvent:
- ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in distilled water
- Positive control substance:
- sodium azide
- Remarks:
- -MA; TA 100, TA 1535; 10 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- -MA; 10 µg/plate TA 98; 40 µg/plate TA 1537
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in distilled water
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- -MA; TA 102; 1 µL/plate
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- +MA; all strains; 2.5 µg/plate, 10 µg/plate for TA 102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation), pre-incubation
ACTIVATION:
Protein concentrations in S9 preparation:
- 34.7 mg/mL phenobarbital
- 33 mg/mL ß-naphthoflavone
S9 mix included 5% S9 and the following cofactors: 8 mM MgCl₂; 33 mM KCl; 5 mM glucose-6-phosphate; 4 mM NADP. The final concentration of S9 in the plates was approximately 1%.
DURATION
- Preincubation period: 60 min at 27°C
- Exposure duration: after solidification, the plates were inverted and incubated at 37°C for at least 48 h in the dark
SELECTION AGENT: histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates. The inital plate incorporation assay was repeated using the preincubation method.
DETERMINATION OF CYTOTOXICITY
- Method: other: clearing or diminuation of background bacterial lawn/reduction in number of revertants down to a mutation faction of approximately ≤0.5 in relation to the solvent control - Evaluation criteria:
- A test item is considered as 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 test strain with or without metabolic activation.
A biologically relevant increase is:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in test strains TA 1537 and TA 1535 the number of reversions is at least three times higher than the reversion rate of the solvent control.
Results and discussion
Test results
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- No mutagenic potential observed
Any other information on results incl. tables
Plate incorporation test: number of revertant colonies per plate (mean of 3 plates)
Dose/plate |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
|
Distilled water |
29 |
21 |
121 |
83 |
8 |
6 |
6 |
9 |
313 |
268 |
Ethanol |
31 |
21 |
103 |
90 |
6 |
5 |
4 |
8 |
261 |
258 |
0.0316 µL |
27 |
25 |
117 |
96 |
7 |
11 |
4 |
6 |
367 |
305 |
0.100 µL |
30 |
25 |
111 |
102 |
8 |
7 |
11 |
11 |
369 |
300 |
0.316 µL |
32 |
27 |
110 |
105 |
7 |
12 |
6 |
6 |
397 |
305 |
1.000 µL |
32 |
26 |
121 |
103 |
6 |
6 |
7 |
8 |
337 |
290 |
2.50 µL |
34 |
23 |
122 |
100 |
10 |
6 |
7 |
9 |
338 |
324 |
5.0 µL |
34 |
21 |
111 |
86 |
7 |
6 |
7 |
7 |
369 |
279 |
4-NOPD 10 µg |
- |
283 |
- |
- |
- |
- |
- |
51 |
- |
- |
2-AA 2.5 µg |
2822 |
- |
2300 |
- |
157 |
- |
285 |
- |
964 |
- |
NaN310 µg |
- |
- |
- |
482 |
- |
463 |
- |
- |
- |
- |
MMS 1 µL |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2395 |
Plate-incubation test: number of revertant colonies per plate (mean of 3 plates)
Dose/plate |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
|
Distilled water |
32 |
19 |
82 |
81 |
16 |
17 |
5 |
7 |
236 |
187 |
Ethanol |
29 |
21 |
97 |
61 |
11 |
9 |
5 |
4 |
208 |
198 |
0.0316 µL |
35 |
20 |
93 |
92 |
16 |
18 |
10 |
7 |
212 |
198 |
0.100 µL |
28 |
19 |
92 |
81 |
14 |
11 |
7 |
6 |
185 |
164 |
0.316 µL |
31 |
21 |
77 |
74 |
14 |
14 |
7 |
7 |
151 |
136 |
1.000 µL |
26 |
19 |
89 |
62 |
12 |
10 |
8 |
7 |
142 |
109 |
2.50 µL |
28 |
23 |
92 |
77 |
16 |
17 |
10 |
8 |
182 |
134 |
5.0 µL |
28 |
21 |
100 |
94 |
15 |
15 |
11 |
6 |
232 |
197 |
4-NOPD 10 µg |
- |
291 |
- |
- |
- |
- |
- |
84 |
- |
- |
2-AA 2.5 µg |
2908 |
- |
1124 |
- |
92 |
- |
179 |
- |
567 |
- |
NaN310 µg |
- |
- |
- |
226 |
- |
1226 |
- |
- |
- |
- |
MMS 1 µL |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2199 |
4-NOPD = 4-nitro-o-phenylene-diamine
2-AA = 2-aminoanthracene
NaN3= sodium azide
MMS = methylmethanesulfonate
Applicant's summary and conclusion
- Conclusions:
- Tetradecamethylhexasiloxane 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 preincubation 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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