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EC number: 242-560-0 | CAS number: 18765-38-3
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-05-06 to 2015-11-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 2014-09-26
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Tetrakis(2-butoxyethyl) orthosilicate
- EC Number:
- 242-560-0
- EC Name:
- Tetrakis(2-butoxyethyl) orthosilicate
- Cas Number:
- 18765-38-3
- Molecular formula:
- C24H52O8Si
- IUPAC Name:
- tetrakis(2-butoxyethyl) orthosilicate
- Reference substance name:
- tetrakis(2-butoxyethoxy)silane
- IUPAC Name:
- tetrakis(2-butoxyethoxy)silane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM (minimum essential medium) with 10 % FBS, 100 U/100 μg/mL penicillin/streptomycin solution, 2 mM L-glutamine, 2.5 μg/mL amphotericin, 25 mM HEPES
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
- 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
With metabolic activator (S9 mix) - 0.1 μg/mL , 0.2 μg/mL , 0.5 μg/mL
Without metabolic activator (S9 mix) - 5 μg/mL, 10 μg/mL, 20 μg/mL
Experiment II
Without metabolic activator (S9 mix) - 0.02 μg/mL, 0.05 μg/mL, 0.1 μg/mL, 0.2 μg/mL, 0.5 μg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofurane (THF)
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the cells and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- treatment medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- tetrahydrofuran
- 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:
- tetrahydrofuran
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- ACTIVATIOR: Phenobarbital (80 mg/kg bw) and β-naphthoflavone (100 mg/kg bw) induced rat liver S9. An appropriate quantity of the S9 supernatant was thawed and mixed with S9 cofactor solution to result in a final protein concentration of 0.75 mg/mL in the cultures. Cofactors were added to the S9 mix to reach the following concentrations:8 mM MgCl2, 33mM KCl, 5mM Glucose-6-phosphate, 5mM NADP in 100 mM sodium-phosphate-buffer pH 7.4
METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
Experiment I: 4 hours, with and without metabolic activation
Experiment II: 21 hours, without metabolic activation
- Expression time (cells in growth medium):
Experiment I: 21 hours
Experiment II: The complete medium containing the different concentrations of the test material is not changed until preparation of the cells.
- Fixation time (start of exposure up to fixation or harvest of cells): The cells are fixed at least two times with 3 + 1 methanol + glacial acetic acid and spread onto the slides.
Experiment I: 21 hours
Experiment II: 21 hours
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: Duplicate cultures
NUMBER OF CELLS EVALUATED: 150 metaphases per culture were scored for chromosomal aberrations (300)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index and relative increase in cell count (RICC)
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A result is considered positive when there is a clear and dose-related increase in the number of cells with aberrations, and a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range.
- Statistics:
- 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. Aberrant cells without gaps were only used for the calculation. Gaps are recorded separately and reported but generally not included in the total aberration frequency calculation according to the guideline.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In experiment I, precipitation of the test item was noted without metabolic activation at a concentration of 1 μg/mL and with metabolic activation at a concentration of 20 μg/mL.
In experiment II, precipitation of the test item was seen without metabolic activation at a concentration of 5 μg/mL.
COMPARISON WITH HISTORICAL CONTROL DATA: The solvent and positive controls were within the range of historical data.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item. - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Summary of Experimental Results
|
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, 21 hour preparation interval |
C |
0 |
111 |
114 |
2.3 |
1.3 |
0.0% - 4.0 % aberrant cells |
- |
|
S |
0 |
100 |
100 |
2.7 |
2.0 |
- |
|||
2 |
0.2 |
105 |
93 |
5.0 |
3.3 |
- |
|||
3 |
0.5 |
103 |
79 |
6.0 |
2.7 |
- |
|||
4 (P) |
1 |
94 |
79 |
8.0 |
4.0 |
+ |
|||
EMS |
900 |
122 |
108 |
12.0 |
9.3 |
- |
|||
|
|||||||||
Experiment II 21 hour treatment, 21 hour preparation interval |
C |
0 |
108 |
119 |
4.0 |
2.7 |
0.0 % - 4.0 % aberrant cells |
- |
|
S |
0 |
100 |
100 |
4.7 |
2.3 |
- |
|||
6 |
1 |
104 |
95 |
4.3 |
1.7 |
- |
|||
7 |
2 |
144 |
98 |
3.7 |
1.3 |
- |
|||
8 |
5 |
120 |
94 |
3.0 |
1.3 |
+ |
|||
EMS |
400 |
81 |
84 |
10.7 |
9.3 |
- |
|||
Experiment I, with metabolic activation |
|||||||||
Experiment I 4 hour treatment, 21 hour preparation interval |
C |
0 |
86 |
121 |
2.0 |
1.3 |
0.0 % - 4.3 % aberrant Cells |
- |
|
S |
0 |
100 |
100 |
2.7 |
2.0 |
- |
|||
1 |
5 |
89 |
113 |
1.7 |
1.3 |
- |
|||
2 |
10 |
101 |
90 |
1.7 |
1.3 |
- |
|||
3 (P) |
20 |
94 |
87 |
2.0 |
1.0 |
+ |
|||
CPA |
1.5 |
103 |
100 |
8.3 |
7.7 |
- |
The mitotic index was determined in 1000 cells per culture of each test group.
C: Negative Control (Culture Medium)
S: Solvent Control (THF)
EMS: Ethylmethanesulfonate
CPA: Cyclophosphamide
Relative Mitotic Index: the relative mitotic index is related to the negative controls; the mitotic index is determined in 1000 cells per culture of each test group.
RICC: Relative Increase in Cell Count, calculated by the increase in cell number of the test groups compared to the control groups. The cell count was determined by a cell counter per culture for each test group
- without precipitation, + with precipitation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
Tetrakis(2-butoxyethyl)silicate has been tested in a valid study according to OECD 473 and under GLP, up to precipitation concentrations 1 μg/mL and 20 μg/mL. No increase in the number of cells with aberrations was observed either with or without metabolic activation in Chinese hamster lung fibroblasts (V79). Appropriate solvent 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.
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