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EC number: 300-346-5 | CAS number: 93925-43-0
- 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:
- 02 - 19 Dec 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 2008
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane
- EC Number:
- 300-346-5
- EC Name:
- Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane
- Cas Number:
- 93925-43-0
- Molecular formula:
- C4H8O2, C20H44O4SiSn, C24H52O6SiSn, C40H84O8SiSn2, C60H128O12Si2Sn3, C80H172O16Si3Sn4, C100H216O20Si4Sn5
- IUPAC Name:
- Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane
Constituent 1
Method
- Target gene:
- his operon; trp operon
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:
- Cofactor supplemented post-mitochondrial factor (S9 mix), prepared from the livers of male Sprague Dawley rats treated with Aroclor (500 mg/kg bw).
- Test concentrations with justification for top dose:
- Dose range finding test (TA100): 3, 10, 33, 100, 333, 1000, 3333 and 5000 µg/plate with metabolic activation (5% (v/v) S9 mix) and without metabolic activation
First experiment (TA98, TA 1535, TA1537, WP2uvrA): 3, 10, 33, 100, 333, 1000, 3333 and 5000 µg/plate with metabolic activation (5% (v/v) S9 mix) and without metabolic activation
Second experiment (all strains): 3, 10, 33, 100, 333, 1000, 3333 and 5000 µg/plate with metabolic activation (10% (v/v) S9 mix) and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol (extra pure)
- Justification for choice of solvent/vehicle: Due to the reactivity to moisture of the test substance, ethanol was selected as the vehicle. At concentrations of 10 mg/mL and higher the test substance was suspended in ethanol. At concentrations of 3.33 mg/mL and lower the test substance was dissolved in ethanol.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191: 2.5 µg/plate for TA1537 (-S9); 2-aminoanthracene: 1, 2.5, 5 or 10 µg/plate for all strains (+S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 ± 4 h
NUMBER OF REPLICATIONS: triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined.
OTHER
Justification for using S9-mix prepared from rats treated with different substances:
Since rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone and by a combination of Aroclor are recommended by the OECD guideline and the positive control data were within the laboratory historical range for each tester strain, this deviation of the S9 homogenate had no effect on the results of the study. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three times the concurrent vehicle control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three times the concurrent vehicle control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- Mean values and standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: but tested up to precipitating concentrations and up to the limit dose concentration of 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: but tested up to precipitating concentrations and up to the limit dose concentration of 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reduction of the revertant colonies at concentrations of 3333 and 5000 µg/plate without metabolic activation; tested up to the limit dose concentration of 5000 μg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: but tested up to precipitating concentrations and up to the limit dose concentration of 500 µg/plate
- 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:
- other: but tested up to precipitating concentrations and up to the limit dose concentration of 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The test substance was tested in the tester strains TA100 with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 μg/plate with and without metabolic activation. This dose range finding test is reported as a part of the first experiment of the mutation test. Precipitation of the test substance on the plates was observed at the start of the incubation period at concentrations of 1000 μg/plate and upwards and at 5000 μg/plate at the end of the incubation period. To determine the toxicity of the test substance, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined. No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed. In strain TA100 (presence of S9-mix), fluctuations in the number of revertant colonies below the laboratory historical control data range were observed. However, since no dose-relationship was observed, the reductions are not considered to be caused by toxicity of the test substance. In the dose range finding test, no increase in the number of revertants was observed upon treatment with the test substance under all conditions tested.
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The slight precipitate does not influence automated counting of the plate, the moderate precipitate required the plate to be hand counted.
Experiment I: Precipitation on the plates was observed at the start of the incubation period at concentrations of 1000 μg/plate and above. Precipitation on the plates was observed at the end of the incubation period at concentration of 333 μg/plate and above, except in tester strain TA98 where precipitation was observed at 1000 μg/plate and above. The precipitation of the test material at the dose level of 333 μg/plate contained a few particles only (please refer to Table 1 under "Any other information on results incl. tables").
Experiment II: Precipitation on the plates was observed at the start of the incubation period at the concentration of 1000 μg/plate and above. Precipitation on the plates was observed at the end of the incubation period at concentrations of 1000 μg/plate and above. Except in tester strain TA1535 (with and without metabolic activation) and TA98 (with metabolic activation) where a few particles of the test material were also observed at the dose level of 333 μg/ml (please refer to Table 2 under "Any other information on results incl. tables").
HISTORICAL CONTROL DATA
- Positive historical control data: The obtained data falls within the historical control data range (please refer to Table 4 under "Any other information on results incl. tables").
- Negative (solvent/vehicle) historical control data: The obtained data falls within the historical control data range (please refer to Table 3 under "Any other information on results incl. tables").
Any other information on results incl. tables
Table 1: Test results of Experiment I
With or without S9 Mix | Test substance concentration | Mean number of revertant colonies per plate | ||||
(μg/plate) | (average of 3 plates ± Standard deviation) | |||||
Base-pair substitution type | Frameshift type | |||||
TA 1535 | TA100 | WP2uvrA | TA98 | TA1537 | ||
– | Solvent control | 13 ± 5 | 110 ± 26 | 23 ± 9 | 20 ± 6 | 10 ± 1 |
– | 3 | - | 116 ± 19 | - | - | - |
– | 10 | - | 129 ± 22 | - | - | - |
– | 33 | 13 ± 2 | 99 ± 14 | 22 ± 5 | 22 ± 2 | 5 ± 1 |
– | 100 | 8 ± 3 | 94 ± 3 | 22 ± 6 | 28 ± 14 | 3 ± 1 |
– | 333 | 4 ± 2 SP | 92 ± 27 | 23 ± 3 SP | 12 ± 4 | 3 ± 2 SP |
– | 1000 | 4 ± 1 SP | 77 ± 8 | 19 ± 4 SP | 11 ± 2 SP | 4 ± 1 SP |
– | 3333 | 3 ± 1 SP | 85 ± 11 | 22 ± 3 SP | 8 ± 4 SP | 5 ± 1 SP |
– | 5000 | 3 ± 2 SP | 93 ± 14 | 26 ± 1 SP | 9 ± 2 SP | 4 ± 1 SP |
Positive controls, -S9 |
Name | SA | MMS | 4-NQO | NF | ICR-191 |
Concentrations (μg/plate) | 5 | 650 | 10 | 10 | 2.5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 728 ± 18 | 885 ± 27 | 925 ± 347 | 1067 ± 29 | 886 ± 10 | |
+ | Solvent control | 16 ± 5 | 129 ± 17 | 25 ± 7 | 20 ± 5 | 9 ± 3 |
+ | 3 | - | 127 ± 9 | - | - | - |
+ | 10 | - | 146 ± 43 | - | - | - |
+ | 33 | 12 ± 3 | 118 ± 32 | 22 ± 6 | 26 ± 8 | 5 ± 1 |
+ | 100 | 8 ± 1 | 89 ± 10 | 26 ± 3 | 17 ± 2 | 4 ± 1 |
+ | 333 | 5 ± 2 SP | 83 ± 12 | 25 ± 7 SP | 24 ± 5 | 3 ± 1 SP |
+ | 1000 | 6 ± 1 SP | 54 ± 9 | 25 ± 2 SP | 18 ± 3 SP | 4 ± 3 SP |
+ | 3333 | 5 ± 2 SP | 57 ± 7 | 27 ± 4 SP | 18 ± 2 SP | 3 ± 1 SP |
+ | 5000 | 5 ± 2 SP | 58 ± 3 | 24 ± 5 SP | 19 ± 2 SP | 2 ± 1 SP |
Positive controls, +S9 (5% (v/v)) | Name | 2AA | 2AA | 2AA | 2AA | 2AA |
Concentrations (μg/plate) | 2.5 | 1 | 10 | 1 | 2.5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 197 ± 6 | 1009 ± 16 | 925 ± 347 | 1009 ± 16 | 415 ± 36 |
Solvent control: 0.1 mL ethanol
SA = sodium azide
MMS = methyl methane sulfa
4NQO = 4-nitroquinoline-N-oxide
NF = 2-nitrofluorene
2AA = 2-aminoanthracene
SP = slight precipitate
Table 2: Test results of Experiment II
With or without S9-Mix | Test substance concentration | Mean number of revertant colonies per plate | ||||
(μg/plate) | (average of 3 plates ± Standard deviation) | |||||
Base-pair substitution type | Frameshift type | |||||
TA 1535 | TA100 | WP2uvrA | TA98 | TA1537 | ||
– | Solvent control | 9 ± 1 | 120 ± 30 | 17 ± 4 | 16 ± 4 | 6 ± 1 |
– | 100 | 4 ± 1 | 84 ± 5 | 20 ± 1 | 16 ± 3 | 8 ± 4 |
– | 333 | 3 ± 1 SP | 92 ± 12 | 18 ± 4 | 12 ± 4 | 5 ± 5 |
– | 1000 | 3 ± 1 SP | 89 ± 7 SP | 24 ± 3 SP | 16 ± 1 SP | 2 ± 1 SP |
– | 3333 | 3 ± 2 SP | 94 ± 2 SP | 20 ± 4 SP | 15 ± 3 SP | 2 ± 1 SP |
– | 5000 | 3 ± 1 SP | 89 ± 9 SP | 19 ± 1 SP | 13 ± 1 SP | 2 ± 1 SP |
Positive controls, –S9 | Name | SA | MMS | 4-NQO | NF | ICR-191 |
Concentrations (μg/plate) | 5 | 650 | 10 | 10 | 2.5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 844 ± 14 | 838 ± 15 | 1232 ± 41 | 1081 ± 28 | 797 ± 35 | |
+ | Solvent control | 11 ± 4 | 110 ± 2 | 22 ± 3 | 15 ± 3 | 7 ± 4 |
+ | 100 | 8 ± 5 | 79 ± 15 | 18 ± 2 | 26 ± 8 | 1 ± 1 |
+ | 333 | 4 ± 1 SP | 93 ± 13 | 20 ± 2 | 19 ± 6 SP | 5 ± 4 |
+ | 1000 | 3 ± 2 SP | 92 ± 12 SP | 16 ± 2 SP | 19 ± 7 SP | 3 ± 1 SP |
+ | 3333 | 4 ± 1 SP | 89 ± 10 SP | 15 ± 4 SP | 17 ± 3 SP | 5 ± 1 SP |
+ | 5000 | 4 ± 2 SP | 69 ± 6 SP | 16 ± 6 SP | 14 ± 6 MP | 1 ± 2 SP |
Positive controls, +S9 (10% (v/v)) | Name | 2AA | 2AA | 2AA | 2AA | 2AA |
Concentrations (μg/plate) | 2.5 | 2.5 | 10 | 1 | 5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 189 ± 18 | 1341 ± 68 | 387 ± 21 | 780 ± 54 | 267 ± 11 |
Solvent control: 0.1 mL ethanol
SA = sodium azide
MMS = methyl methane sulfa
4NQO = 4-nitroquinoline-N-oxide
NF = 2-nitrofluorene
2AA = 2-aminoanthracene
SP = slight precipitate
Table 3: Historical control data: Negative control
TA 1535 | TA1537 | TA98 | TA100 | WP2uvrA | ||||||
S9 mix | - | + | - | + | - | + | - | + | - | + |
Range | 3 - 25 | 3 - 31 | 2 - 19 | 2 - 16 | 11 - 49 | 12 - 59 | 61 - 195 | 58 - 179 | 8 - 45 | 6 - 46 |
Mean | 10 | 8 | 5 | 5 | 19 | 24 | 106 | 88 | 22 | 23 |
SD | 4 | 3 | 2 | 2 | 5 | 7 | 22 | 21 | 7 | 7 |
n | 1208 | 1216 | 1073 | 1098 | 1191 | 1208 | 1224 | 1221 | 1090 | 1105 |
SD = Standard deviation
n = Number of observations
Table 4: Historical control data: Positive control
TA 1535 | TA1537 | TA98 | TA100 | WP2uvrA | ||||||
S9 mix | - | + | - | + | - | + | - | + | - | + |
Range | 24 - 1270 | 60 - 943 | 89 - 1086 | 82 - 677 | 401 - 1342 | 225 - 1656 | 348 - 1417 | 229 - 1752 | 138 - 1479 | 122 - 1248 |
Mean | 887 | 265 | 314 | 374 | 1016 | 792 | 950 | 1103 | 1074 | 372 |
SD | 112 | 111 | 146 | 104 | 133 | 286 | 117 | 261 | 212 | 137 |
n | 1123 | 1150 | 1011 | 1039 | 1136 | 1157 | 1153 | 1170 | 1023 | 1047 |
SD = Standard deviation
n = Number of observations
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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