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EC number: 217-982-3 | CAS number: 2031-62-1
- 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
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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:
- 2007-02-01 to 2007-02-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- 2-AA was the sole positive control for S9 mix and no information was provided, if the S9 batch used was tested before with an additional positive control substance.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, Munich, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diethoxy(methyl)silane
- EC Number:
- 217-982-3
- EC Name:
- Diethoxy(methyl)silane
- Cas Number:
- 2031-62-1
- Molecular formula:
- C5H14O2Si
- IUPAC Name:
- diethoxy(methyl)silane
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: all strains except TA102 carry a mutation of the uvrB gene coding for the DNA excision repair system (uvrB-), all strains carry the deep rough mutation (rfa), TA102, TA100 and TA98 contain the R-factor plasmid (pkM101) to detect weak mutagens
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated withPhenobarbital and ß-Naphthoflavone
- Test concentrations with justification for top dose:
- - Cytotoxicity pre-experiment: 3.16, 10.0, 31.6, 100, 316, 1000, 2500, and 5000 µg/plate
- Experiment I: 31.6, 100, 316, 1000, 2500, and 5000 µg/plate (with and without metabolic activation - plate incorporation)
- Experiment II: 31.6, 100, 316, 1000, 2500, and 5000 µg/plate (with and without metabolic activation - pre-incubation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubility properties of the test article, compatibility with the S9 activity, and relative non-toxicity to bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- aqua dest.
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 4-nitroquinoline-N-oxide
- sodium azide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 1 h
- Expression time (cells in growth medium): 48 h
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- A cytotoxicity pre-experiment was carried out with the tester strains TA 98 and A 100 to determine the non-toxic concentrations for the main genotoxicity experiments.
- Method: Background lawn assessment / revertant colony counts - Evaluation criteria:
- A test system is considered as mutagenic if
- there is a clear and dose-related increase in the number of revertants and/or a
- biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A result is positive if the number of revertants is significantly increased compared with the solvent control to at least 2-fold of the solvent control for TA 100 and TA 102 and 3-fold of the solvent control for TA 98, TA 1535 and TA 1537.
Cytotoxicity is defined as a reduction in the number of colonies by >50% compared with the solvent control and/or a sparse background lawn.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 100, and TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- up to limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
Any other information on results incl. tables
Table 1: Dose range-finding study. Number of revertants per plate (2 plates per strain).
TA 98 |
TA 100 |
|||||
Concentration (μg/Plate) |
Plate 1 - MA |
Plate 2 + MA |
Cytotoxic (Yes/No) |
Plate 1 - MA |
Plate 2 + MA |
Cytotoxic (Yes/No) |
DMSO |
1 |
1 |
No |
1 |
1 |
No |
3.16 |
0.8 |
1.3 |
No |
1 |
0.9 |
No |
10 |
0.9 |
1.3 |
No |
0.9 |
0.9 |
No |
31.6 |
1.1 |
1.3 |
No |
1 |
0.9 |
No |
100 |
1 |
1.2 |
No |
1 |
0.9 |
No |
316 |
0.7 |
1.3 |
No |
0.9 |
0.8 |
No |
1000 |
0.7 |
1.1 |
No |
0.9 |
1 |
No |
2500 |
0.7 |
1.3 |
No |
0.9 |
0.9 |
No |
5000 |
0.9 |
1.3 |
No |
0.9 |
0.9 |
No |
Positive control |
21.5 |
113.3 |
No |
8 |
20.1 |
No |
table2: Test results of Experiment I (plate incorporation)
with or without S9 -Mix | Test substance | Mean number of revertant colonies per plate (average of 3 plates ± SD) | ||||
concentration | Base-pair substitution type | Frameshift type | ||||
[µg/plate] | TA100 | TA1535 | TA102 | TA98 | TA1537 | |
- | DMSO | 111 ± 3.6 | 10 ± 2.6 | 150 ± 4.0 | 22 ± 2.3 | 7 ± 0.6 |
- | 31.6 | 107 ± 6.2 | 7 ± 3.0 | 128 ± 25.0 | 24 ± 5.2 | 15 ± 3.5 |
- | 100 | 109 ± 11.7 | 11 ± 3.6 | 153 ± 16.5 | 22 ± 6.1 | 16 ± 5.1 |
- | 316 | 100 ± 7.1 | 8 ± 1.7 | 138 ± 12.5 | 15 ± 3.5 | 11 ± 1.0 |
- | 1000 | 98 ± 8.9 | 7 ± 1.5 | 148 ± 7.8 | 16 ± 4.6 | 8 ± 2.5 |
- | 2500 | 99 ± 7.5 | 9 ± 2.0 | 127 ± 21.9 | 16 ± 2.9 | 11 ± 2.6 |
- | 5000 | 96 ± 4.6 | 9 ± 1.5 | 135 ± 19.5 | 20 ± 2.5 | 15 ± 6.8 |
Negative control | Aqua dest. | 108 ± 8.2 | 10 ±2.1 | 188 ± 8.1 | 19 ± 2.6 | 13 ± 2.1 |
Positive controls | Name | NaN3 | NaN3 | MMS | 4 -NOPD | 4 -NOPD |
concentrations [µg/plate] | 10 | 10 | 1µL | 10 | 40 | |
Mean No. of colonies/plate (average of 3 ± SD) | 893 ± 47.4 | 828 ± 38.9 | 1611 ± 208.4 | 481 ± 13.5 | 129 ± 10.6 | |
+ | DMSO | 127 ± 5.3 | 9 ± 4.5 | 192 ± 14.4 | 26 ± 2.6 | 10 ± 4.0 |
+ | 31.6 | 114 ± 15.8 | 9 ± 2.1 | 149 ± 19.9 | 35 ± 1.0 | 11 ± 3.2 |
+ | 100 | 119 ± 6.8 | 6 ± 3.1 | 182 ± 10.3 | 31 ± 6.0 | 12 ± 0.6 |
+ | 316 | 103 ± 6.2 | 10 ± 0.6 | 188 ± 11.5 | 34 ± 3.6 | 11 ± 2.6 |
+ | 1000 | 128 ± 15.7 | 8 ± 1.2 | 212 ± 19.3 | 28 ± 5.0 | 12 ± 0.6 |
+ | 2500 | 120 ± 10.2 | 12 ± 1.0 | 201 ± 24.8 | 35 ± 6.0 | 10 ± 3.5 |
+ | 5000 | 112 ± 6.4 | 9 ± 3.1 | 167 ± 23.5 | 34 ± 2.5 | 14 ± 1.5 |
Negative control | Aqua dest. | 124 ± 11.0 | 7 ± 2.0 | 211 ± 9.7 | 35 ± 3.6 | 13 ± 4.7 |
Positive controls | Name | 2 -AA | 2 -AA | 2 -AA | 2 -AA | 2 -AA |
concentrations [µg/plate] | 2.5 | 2.5 | 10 | 2.5 | 2.5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 2547 ± 100.3 | 102 ± 6.9 | 1156 ± 49.0 | 2945 ± 191.1 | 358 ± 12.0 |
table2:Test results of Experiment II (pre-incubation)
with or without S9 -Mix | Test substance | Mean number of revertant colonies per plate (average of 3 plates ± SD) | ||||
concentration | Base-pair substitution type | Frameshift type | ||||
[µg/plate] | TA100 | TA1535 | TA102 | TA98 | TA1537 | |
- | DMSO | 95 ± 6.8 | 10 ± 3.1 | 178 ± 9.2 | 22 ± 3.5 | 11 ± 3.0 |
- | 31.6 | 89 ± 22.7 | 7 ± 4.5 | 104 ± 21.6 | 19 ± 5.6 | 12 ± 2.0 |
- | 100 | 101 ± 8.2 | 9 ± 1.0 | 146 ± 11.1 | 21 ± 1.7 | 10 ± 3.0 |
- | 316 | 97 ± 10.5 | 6 ± 1.2 | 157 ± 7.2 | 21 ± 1.0 | 7 ± 2.1 |
- | 1000 | 74 ± 13.2 | 6 ± 1.0 | 178 ± 14.8 | 18 ± 1.5 | 7 ± 2.5 |
- | 2500 | 58 ± 10.6 | 4 ± 1.5 | 158 ± 1.5 | 25 ± 4.7 | 9 ± 2.5 |
- | 5000 | 70 ± 7.5 | 7 ± 2.6 | 130 ± 39.5 | 23 ± 0.6 | 12 ± 2.0 |
Negative control | Aqua dest. | 103 ± 14.4 | 7 ± 1.0 | 186 ± 12.1 | 27 ± 3.1 | 9 ± 1.2 |
Positive controls | Name | NaN3 | NaN3 | MMS | 4 -NOPD | 4 -NOPD |
concentrations [µg/plate] | 10 | 10 | 1µL | 10 | 40 | |
Mean No. of colonies/plate (average of 3 ± SD) | 701 ± 14.5 | 842 ± 30.0 | 1716 ± 117.7 | 472 ± 53.1 | 141 ± 9.3 | |
+ | DMSO | 77 ± 4.5 | 9 ± 3.0 | 269 ± 14.4 | 36 ± 3.2 | 10 ± 3.1 |
+ | 31.6 | 84 ± 2.5 | 7 ± 2.0 | 143 ± 38.9 | 30 ± 2.5 | 15 ± 2.3 |
+ | 100 | 88 ± 14.6 | 6 ± 1.2 | 208 ± 26.0 | 42 ± 13.3 | 16 ± 3.1 |
+ | 316 | 92 ± 11.0 | 7 ± 4.0 | 226 ± 10.6 | 41 ± 6.9 | 13 ± 2.3 |
+ | 1000 | 99 ± 6.0 | 7 ± 1.2 | 240 ± 22.9 | 39 ± 7.6 | 9 ± 1.5 |
+ | 2500 | 75 ± 0.6 | 9 ± 0.6 | 206 ± 32.4 | 33 ± 4.2 | 12 ± 1.5 |
+ | 5000 | 86 ± 3.2 | 7 ± 2.1 | 191 ± 44.5 | 43 ± 8.0 | 11 ± 1.5 |
Negative control | Aqua dest. | 100 ± 5.8 | 8 ± 3.1 | 307 ± 13.8 | 37 ± 5.5 | 13 ± 1.7 |
Positive controls | Name | 2 -AA | 2 -AA | 2 -AA | 2 -AA | 2 -AA |
concentrations [µg/plate] | 2.5 | 2.5 | 10 | 2.5 | 2.5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 872 ± 112.1 | 39 ± 7.5 | 1386 ± 138.1 | 1762 ± 40.7 | 120 ± 3.5 |
Applicant's summary and conclusion
- Conclusions:
- The test item was investigated for mutagenicicty to bacteria according to the OECD TG 471, and in compliance with GLP. In two independent experiments (plate incorporation and preincubation) the test material was tested in S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 102 up to limit concentrations with and without a metabolic activation system. No significant increase in the number of revertants was observered in any of the tester strain with and without metabolic activation. Appropriate negative, solvent, and positive controls were included into the test and gave the expected results. Hence, the test item was considered to be not mutagenic to bacteria under the conditions of the test.
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