Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 203-499-5 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial reverse mutation assay: tetradecamethylhexasiloxane was
negative, with and without metabolic activation in S. typhimurium TA
1535, TA 1537, TA 98, TA 100 and TA 102 (OECD 471, 1997) (BSL
Bioservice, 2014).
Mammalian cytogenicity assay: tetradecamethylhexasiloxane was negative,
with and without metabolic activation in Chinese hamster lung
fibroblasts (V79) (OECD 473, 1997) (Bioservice, 2015).
Mammalian mutagenicity assay: tetradecamethylhexasiloxane was negative,
with and without metabolic activation in mouse lymphoma L5178Y cells
(OECD476, 1997) (Eurofins, 2015).
Link to relevant study records
- 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
- 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
- Target gene:
- histidine operon
- 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
- 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. - 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
- 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.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-08-25 to 2014-09-15
- 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)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
Culture medium: MEM (minimum essential medium) supplemented with 10% FBS (fetal bovine serum)
Treatment medium: MEM (minimum essential medium) without FBS
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes - 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:
- Experiment I:
without and with metabolic activation: 0.0313, 0.0625, 0.125, 0.25, 0.5, 1 and 2 μL/mL
Experiment II:
without metabolic activation: 0.0625, 0.125, 0.25, 0.5, 1, 2 and 4 μL/mL
with metabolic activation: 0.125, 0.25, 0.375, 0.75, 1.25, 1.5, 2.5 and 3 μL/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: MEM + 0 % FBS
- Justification for choice of solvent/vehicle: The nature of the test material does not allow the use of solvents. Based on the results of the solubility test the best suited vehicle was MEM cell culture medium - Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: The S9 supernatant was mixed with S9 cofactor solution to result in concentration of 0.75 mg/mL of S9 mix that was added to the cultures. The cofactors added were: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 5 mM NADP in 100 mM sodium-phosphate-buffer pH 7.4.
METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 48 hours
- Exposure duration:
Experiment I: 4 hours with and without metabolic activation
Experiment II: 4 hours with metabolic activation; 20 hours without metabolic activation
- Expression time (cells in growth medium):
Experiment I: 20 hours after the treatment
Experiment II: straight after exposure (without metabolic activation); 20 hours ( 4-hour exposure with metabolic activation).
- Selection time (if incubation with a selection agent): hypotonic solution (0.4% KCl) for 15-20 min
- Fixation time (start of exposure up to fixation or harvest of cells): after 20 hours the cells were fixed with 3 + 1 methanol + glacial acetic acid
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (0.2 μg/mL culture medium) was added 17.5 hours after the start of the treatment.
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: Duplicate lymphocyte cultures
NUMBER OF CELLS EVALUATED: 1000
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index and reduction of degree in cell count
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- - a clear and dose-related increase in the number of cells with aberrations,
- a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range (up to 4.0% aberrant cells without and 4.3% with metabolic activation) - Statistics:
- A statistical evaluation was used as an aid for interpretation of the results. Statistical significance at the 5% level (p< 0.05) was evaluated by the Fischer´s exact test. The p value was used as a limit in judging for significance levels in comparison with the corresponding negative control.
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: pH of suspension was 7.0 ± 0.4
- Effects of osmolality: osmolality was 293 mOsmol/kg
- Precipitation: precipitation was observed at concentrations of 1 μl/ml and higher with and without metabolic activation in experiment I. In experiment II precipitation was observed from 0.5 μl/ml without metabolic activation, and from 1.5 μl/ml with metabolic activation.
RANGE-FINDING/SCREENING STUDIES: Little cytotoxicity was observed in the pre-test, but precipitation was observed.
COMPARISON WITH HISTORICAL CONTROL DATA: The results of positive and solvent controls were within the range of historical controls.
No biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item. - Remarks on result:
- other:
- Remarks:
- No mutagenic potential observed
- Conclusions:
- Tetradecamethylhexasiloxane has been tested in a valid study according to OECD 473 and under GLP, up to precipitating concentrations. No increase in the number of cells with aberrations was observed either with or without metabolic activation in Chinese hamster lung fibroblast (V79) cells. Appropriate negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of this study.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-03-09 to 2015-06-05
- 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)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- TK-locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: complete culture medium
- Properly maintained: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital (80 mg/kg bw) and ß-naphthoflavone (100 mg/kg bw) induced S9 mix
- Test concentrations with justification for top dose:
- Experiment I:
0.0010, 0.0025, 0.005, 0.010, 0.025, 0.05, 0.10, 0.25 and 0.5 μL/mL, with and without metabolic activation
Experiment II:
0.0015, 0.003, 0.008, 0.015, 0.03, 0.08, 0.15 and 0.5 μL/mL, with metabolic activation
0.0025, 0.005, 0.010, 0.025, 0.05, 0.10, 0.25 and 0.5 μL/mL, without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the cells and the S9 activity. - Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: benzo[a]pyrene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION SYSTEM: S9 cofactor solution included S9 at a concentration of 0.75 mg/ml in the cultures. Cofactors added to the S9 mix were: 8 mM MgCl2, 33 mM KCl, 5 mM Glucose-6-phosphate, 5 mM NADP in 100 mM sodium-phosphate-buffer pH 7.4.
METHOD OF APPLICATION: in complete culture medium
DURATION
- Exposure duration:
Experiment I: 4 hours, with and without metabolic activation
Experiment II: 4 hours, with metabolic activation; 24 hours, without metabolic activation
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 14 days
- Determination of cloning efficiency: cells were incubated for 6 days to determine cloning efficiency
SELECTION AGENT (mutation assays): selective medium with TFT
NUMBER OF REPLICATIONS: duplicate cultures
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- The test item was considered mutagenic if the following criteria were met:
- The induced mutant frequency meets or exceeded the Global Evaluation factor (GEF) of 126
mutants per 106 cells
- A dose-dependent increase in mutant frequency was detected. - Statistics:
- Mean values and t-test.
- 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
- Additional information on results:
- PRECIPITATION: Precipitation was observed at 0.5 μL/mL in experiment I and II, with and without metabolic activation
ADDITIONAL INFORMATION ON CYTOTOXICITY: No growth inhibition was observed in experiment I and II, with and without metabolic activation - Remarks on result:
- other:
- Remarks:
- No mutagenic potential observed
- Conclusions:
- Tetradecamethylhexasiloxane has been tested in a valid study according to OECD 476 and under GLP. No statistically and biologically significant increase in the mutant frequency was observed with or without metabolic activation when tested up to precipitating concentrations in mouse lymphoma L5178Y cells. Appropriate solvent, negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test.
Referenceopen allclose all
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
Table 1. Summary, Experiment I and II, with and without metabolic activation
|
Dose Group |
Concentration µg/mL |
Relative Mitotic Index (%) |
RICC (%) |
Mean % Aberrant Cells |
Historical Laboratory Negative Control Range |
Precipitation |
||
Including Gaps |
Excluding Gaps |
||||||||
Experiment I and II, without metabolic activation |
|||||||||
Experiment I 4 hour treatment, 20 hour preparation interval |
C |
0 |
100 |
100 |
3.5 |
0.5 |
0.0% - 4.0 % aberrant cells |
- |
|
5 |
0.5 |
120 |
113 |
2.5 |
2.0 |
- |
|||
6 |
1 |
113 |
97 |
3.0 |
1.5 |
+ |
|||
7 |
2 |
124 |
121 |
1.5 |
1.5 |
+ |
|||
EMS |
900 |
127 |
89 |
13.0 |
9.0 |
- |
|||
|
|||||||||
Experiment II 20 hour treatment, 20 hour preparation interval |
C |
0 |
100 |
100 |
2.5 |
0.5 |
0.0 % - 4.0 % aberrant cells |
- |
|
3 |
0.25 |
99 |
106 |
4.5 |
2.0 |
- |
|||
4 |
0.5 |
102 |
98 |
2.5 |
0.5 |
+ |
|||
5 |
1 |
98 |
103 |
2.5 |
1.0 |
+ |
|||
6 |
2 |
95 |
105 |
6.5 |
2.5 |
+ |
|||
7 |
4 |
92 |
100 |
6.5 |
3.0 |
+ |
|||
EMS |
400 |
80 |
81 |
13.5 |
10.5 |
- |
|||
Experiment I and II, with metabolic activation |
|||||||||
Experiment I 4 hour treatment, 20 hour preparation interval |
C |
0 |
100 |
100 |
3.5 |
2.0 |
0.0 % - 4.3 % aberrant Cells
0.0 % - 4.0 % aberrant cells |
- |
|
5 |
0.5 |
96 |
144 |
2.0 |
1.0 |
- |
|||
6 |
1 |
92 |
111 |
2.5 |
1.5 |
+ |
|||
7 |
2 |
97 |
119 |
4.0 |
2.0 |
+ |
|||
CPA |
1.1 |
96 |
108 |
18.5 |
15.5 |
- |
|||
|
|
||||||||
Experiment II 20 hour treatment, 20 hour preparation interval |
C |
0 |
100 |
100 |
4.5 |
2.5 |
- |
||
5 |
0.75 |
109 |
100 |
8.5 |
4.0 |
- |
|||
6 |
1.5 |
99 |
98 |
3.5 |
1.0 |
+ |
|||
7 |
2.5 |
102 |
97 |
3.0 |
1.5 |
+ |
|||
CPA |
0.83 |
90 |
88 |
18.5 |
10.5 |
- |
C: Negative Control (Culture Medium)
CPA: Cyclophosphamide
- without precipitation, + with precipitation
Table 1. Experiment I, without metabolic activation
|
Test Group |
Concentrations µL/ml |
RCE % |
RTG % |
MF (mutants/106cells) |
IMF (mutants/106cells) |
GEF exceeded |
Statistical Significant Increase |
Experiment I: without metabolic activation |
C1 |
0 |
103.0 |
97.2 |
88.6 |
/ |
/ |
/ |
C2 |
0 |
115.2 |
105.1 |
88.6 |
/ |
/ |
/ |
|
S1 |
0 |
100.0 |
100.0 |
73.9 |
/ |
/ |
/ |
|
S2 |
0 |
100.0 |
100.0 |
73.9 |
/ |
/ |
/ |
|
2 |
0.0010 |
119.0 |
108.5 |
65.8 |
-8.2 |
- |
- |
|
3 |
0.0025 |
95.5 |
85.5 |
97.9 |
23.9 |
- |
+ |
|
4 |
0.005 |
104.7 |
90.9 |
60.5 |
-13.4 |
- |
- |
|
5 |
0.010 |
99.9 |
87.1 |
76.5 |
2.6 |
- |
- |
|
6 |
0.025 |
103.0 |
99.7 |
67.9 |
-6.1 |
- |
- |
|
7 |
0.05 |
106.3 |
87.3 |
54.9 |
-19.0 |
- |
- |
|
8 |
0.10 |
113.3 |
104.2 |
61.8 |
-12.1 |
- |
- |
|
9 |
0.25 |
123.2 |
106.9 |
78.6 |
4.7 |
- |
- |
|
10 |
0.5 |
137.2 |
137.8 |
41.6 |
-32.4 |
- |
+ |
|
EMS |
300 μg/mL |
76.8 |
52.6 |
967.7 |
893.8 |
+ |
+ |
|
MMS |
10 μg/mL |
80.2 |
58.7 |
582.5 |
508.5 |
+ |
+ |
Table 2. Experiment II, without metabolic activation
|
Test Group |
Concentrations µL/ml |
RCE % |
RTG % |
MF (mutants/106cells) |
IMF (mutants/106cells) |
GEF exceeded |
Statistical Significant Increase |
Experiment II: without metabolic activation |
C1 |
0 |
88.8 |
97.6 |
68.0 |
/ |
/ |
/ |
C2 |
0 |
90.1 |
105.3 |
68.0 |
/ |
/ |
/ |
|
S1 |
0 |
100.0 |
100.0 |
86.0 |
/ |
/ |
/ |
|
S2 |
0 |
100.0 |
100.0 |
86.0 |
/ |
/ |
/ |
|
3 |
0.0025 |
113.9 |
99.1 |
72.1 |
-13.9 |
- |
- |
|
4 |
0.005 |
88.8 |
76.7 |
89.1 |
3.2 |
- |
- |
|
5 |
0.010 |
122.9 |
122.0 |
57.2 |
-28.8 |
- |
- |
|
6 |
0.025 |
88.8 |
77.6 |
97.6 |
11.6 |
- |
- |
|
7 |
0.05 |
100.8 |
103.9 |
91.8 |
5.9 |
- |
- |
|
8 |
0.10 |
93.0 |
91.1 |
90.0 |
4.1 |
- |
- |
|
9 |
0.25 |
90.1 |
90.5 |
97.8 |
11.9 |
- |
- |
|
10 |
0.5 |
106.1 |
104.7 |
92.1 |
6.1 |
- |
- |
|
EMS |
200 μg/mL |
52.7 |
31.0 |
2366.9 |
2281.0 |
+ |
+ |
|
MMS |
8 μg/mL |
58.3 |
36.1 |
1081.3 |
995.4 |
+ |
+ |
Table 3. Experiment I, with metabolic activation
|
Test Group |
Concentrations µL/ml |
RCE % |
RTG % |
MF (mutants/106cells) |
IMF (mutants/106cells) |
GEF exceeded |
Statistical Significant Increase |
Experiment I: with metabolic activation |
C1 |
0 |
102.1 |
86.1 |
73.6 |
/ |
/ |
/ |
C2 |
0 |
125.6 |
122.4 |
73.6 |
/ |
/ |
/ |
|
S1 |
0 |
100.0 |
100.0 |
82.0 |
/ |
/ |
/ |
|
S2 |
0 |
100.0 |
100.0 |
82.0 |
/ |
/ |
/ |
|
2 |
0.0010 |
121.4 |
140.4 |
63.9 |
-18.2 |
- |
- |
|
3 |
0.0025 |
117.5 |
120.0 |
75.3 |
-6.8 |
- |
- |
|
4 |
0.005 |
105.2 |
116.7 |
64.4 |
-17.7 |
- |
- |
|
5 |
0.010 |
113.8 |
119.6 |
60.9 |
-21.2 |
- |
- |
|
6 |
0.025 |
108.5 |
117.5 |
93.0 |
11.0 |
- |
- |
|
7 |
0.05 |
112.0 |
123.1 |
67.8 |
-14.3 |
- |
- |
|
8 |
0.10 |
119.4 |
137.3 |
69.4 |
-12.6 |
- |
- |
|
9 |
0.25 |
134.7 |
146.4 |
70.7 |
-11.3 |
- |
- |
|
10 |
0.5 |
113.8 |
123.8 |
77.3 |
-4.7 |
- |
- |
|
B[a]P |
3.5 μg/mL |
68.2 |
23.3 |
656.5 |
574.5 |
+ |
+ |
Table 4. Experiment II, with metabolic activation
|
Test Group |
Concentrations µL/ml |
RCE % |
RTG % |
MF (mutants/106cells) |
IMF (mutants/106cells) |
GEF exceeded |
Statistical Significant Increase |
Experiment II: with metabolic activation |
C1 |
0 |
102.7 |
91.1 |
64.6 |
/ |
/ |
/ |
C2 |
0 |
91.1 |
92.7 |
64.6 |
/ |
/ |
/ |
|
S1 |
0 |
100.0 |
100.0 |
66.1 |
/ |
/ |
/ |
|
S2 |
0 |
100.0 |
100.0 |
66.1 |
/ |
/ |
/ |
|
3 |
0.0015 |
104.3 |
102.0 |
71.0 |
4.8 |
- |
- |
|
4 |
0.003 |
93.8 |
87.5 |
70.2 |
4.0 |
- |
- |
|
5 |
0.008 |
109.3 |
105.0 |
61.6 |
-4.5 |
- |
- |
|
6 |
0.015 |
120.5 |
113.6 |
49.0 |
-17.1 |
- |
- |
|
7 |
0.03 |
111.0 |
115.1 |
59.4 |
-6.8 |
- |
- |
|
8 |
0.08 |
96.6 |
102.9 |
47.7 |
-18.4 |
- |
- |
|
9 |
0.15 |
105.9 |
104.6 |
57.4 |
-8.7 |
- |
- |
|
10 |
0.5 |
91.1 |
89.5 |
79.7 |
13.6 |
- |
- |
|
B[a]P |
3.5 μg/mL |
99.6 |
62.4 |
576.2 |
510.1 |
+ |
+ |
C: Negative Controls
S: Solvent Controls
Relative Cloning Efficiency, RCE = [(CE dose group / CE of corresponding controls) x 100]
Cloning Efficiency, CE = ((-LN (((96 - (mean P1,P2)) / 96)) / 1.6) x 100)
Relative Total Growth, RTG = (RSG x RCE)/100
Mutant Frequency, MF = {-ln [negative cultures/total wells (selective medium)] / -ln [negative cultures/total wells (non selective medium)]}x800
Induced Mutant Frequency, IMF = mutant frequency sample – mean value mutant frequency corresponding controls
Global Evaluation Factor, GEF (126); +: GEF exceeded, -: GEF not exceeded
Statistical significant increase in mutant frequency compared to solvent controls (Mann Whitney test , p<0.05).
+: significant; -not significant
EMS: Ethylmethanesulfonate [200 μg/mL and 300 μg/mL]
MMS: Methylmethanesulfonate [8 μg/mL and 10 μg/mL]
B[a]P: Benzo[a]pyrene [3.5 μg/mL]
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Tetradecamethylhexasiloxane has been tested in a valid bacterial reverse mutation assay, according to the OECD TG 471, and under GLP, using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or TA 102 (BSL Bioservice, 2014).
No increase in the number of revertants was observed in any test strain, with or without metabolic activation, when tested up to limit concentration. Appropriate negative, positive and solvent controls were added and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test. The study was considered reliability 1.
Tetradecamethylhexasiloxane has been tested for ability to cause chromosome aberrations in Chinese hamster lung fibroblasts (V79) according to OECD TG 473 and under GLP (Bioservice, 2015). No increase in the number of cells with aberrations was observed either with or without metabolic activation in Chinese hamster V79 cells, when tested up to precipitating concentrations. Appropriate negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of this study. The study was considered reliability 1.
Tetradecamethylhexasiloxane has been tested for mutagenicity in mouse lymphoma L5178Y cells according to OECD TG 476, and under GLP (Eurofins, 2015). No test-substance induced increase in the number of mutations was observed, when tested up to precipitating concentrations. Appropriate solvent, negative (treatment medium) and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the study. The study was considered reliability 1.
Tetradecamethylhexasiloxane contains no structural elements which may be
of concern for potential mutagenic activity. In vitro tests are
negative, including a bacterial mutagenicity, mammalian cytogenicity and
mammalian mutagenicity studies, therefore in vivo testing is not
required.
Justification for classification or non-classification
Based on the available data for tetradecamethylhexasiloxane, no classification is required for genetic toxicity according to Regulation (EC) No 1272/2008.
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.