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EC number: 217-983-9 | CAS number: 2031-67-6
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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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:
- 07 Nov 2011 - 22 Mar 2012
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triethoxy(methyl)silane
- EC Number:
- 217-983-9
- EC Name:
- Triethoxy(methyl)silane
- Cas Number:
- 2031-67-6
- Molecular formula:
- C7H18O3Si
- IUPAC Name:
- triethoxy(methyl)silane
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Keep the substance in cool and dark place; tightly closed, in refrigerator (1 - 10 °C); fill nitrogen after opening of package.
- Stability under test conditions: The test substance is stable. The stability is confirmed at the end of exposure using IR spectroscopy.
- Solubility and stability of the test substance in the solvent/vehicle: soluble in DMSO at 50 mg/mL
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No reactivity
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: Test material was measured and diluted in DMSO at 50 mg/mL. This solution was diluted sequencly in the appropriate concentration.
Method
- Target gene:
- trp operon and his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, prepared from the livers of rats treated with phenobarbital and 5-6-benzoflavone
- Test concentrations with justification for top dose:
- Experiment 1 and 2: 39.1, 78.1, 156, 313, 652, and 1250 μg/mL were tested for TA1535 (up to the cytotoxic concentration)
Experiment 1 and 2: 156, 313, 652, 1250, 2500 and 5000 μg/mL were tested for TA100 , WP2uvrA, TA98 and TA1537 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: due to the limited solubility of the test substance in water, DMSO was selected as the vehicle
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- furylfuramide
- other: 6-chloro-9-[3-(2-chloroethylamino)propylamino]-2-methoxyacridine dihydrochloride for TA1537 without S9 mix, 2-amonoanthracene for TA1535 and WP2uvrA with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 49.5 h for the first experiment and 48 h for the second experiment
NUMBER OF REPLICATIONS:
3 replication each in 2 independent experiments
NUMBER OF CELLS EVALUATED: all cells
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- A test substance was considered positive in the Ames test if:
a) a more than 2-fold increase in the number of revertants was observed
b) the positive result was reproducible inspite of dose-related increase. - 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:
- cytotoxicity
- Remarks:
- at 1250 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- ≥ 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- cytotoxicity
- Remarks:
- ≥ 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Preliminary test was performed with 19.5, 78.1, 313, 1250 and 5000 μg/mL with/without S9.
There was no reverse mutation observed in all species at all concentration. Furthermore, cytotoxicity was observed at 1250 μg/mL and more (TA1535) and at 5000 μg/mL (WP2urvA, TA98, TA100 and TA1537) with and without metabolic activation.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: number of revertant colonies
Any other information on results incl. tables
Table 1. Test results of the experiment 1 with or without S9 mix for triethoxy(methyl)silane
With or without S9 mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (Mean of 3 replicate ± SD) |
|||||
Base-pair substitution type |
Frameshift type |
||||||
TA100 |
TA1535 |
WP2urvA |
TA98 |
TA1537 |
|||
- |
0 |
84 ± 17.6 |
6 2.0± |
20± 3.5 |
12± 3.8 |
5± 2.0 |
|
39.1 |
- |
7± 1.5 |
- |
- |
- |
||
78.1 |
- |
6± 1.0 |
- |
- |
- |
||
156 |
72± 12.1 |
8± 0.6 |
16± 4.9 |
13± 7.6 |
5± 0.6 |
||
313 |
87± 26.2 |
10± 3.5 |
17± 2.1 |
11± 4.6 |
5± 1.0 |
||
625 |
71± 10.2 |
7± 3.5 |
13± 2.0 |
9± 3.2 |
4± 1.2 |
||
1250 |
67± 7.4 |
7± 2.6 |
14± 5.1 |
14± 7.0 |
5± 1.5 |
||
2500 |
0± 0.0* |
NT |
10± 0.6* |
0± 0.0* |
0± 0.0* |
||
5000 |
0± 0.0* |
NT |
5± 2.3* |
0± 0.0* |
0± 0.0* |
||
Positive controls, – S9 mix |
Name |
AF2 |
NaN3 |
AF2 |
AF2 |
ICR-191 |
|
Concentration (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
||
Mean No. of colonies/plate ± SD |
764± 8.1 |
350± 11.0 |
54± 21.5 |
365± 60.1 |
908± 69.8 |
||
+ |
0 |
80± 15.5 |
6± 1.2 |
15± 6.1 |
18± 4.9 |
10± 1.0 |
|
39.1 |
NT |
8± 1.5 |
NT |
NT |
NT |
||
78.1 |
NT |
8± 2.5 |
NT |
NT |
NT |
||
156 |
83± 12.1 |
8± 3.1 |
17± 3.1 |
15± 6.5 |
5± 1.5 |
||
313 |
93± 10.0 |
8± 1.5 |
13± 2.3 |
22± 7.0 |
6± 1.0 |
||
625 |
85± 9.0 |
8± 0.6 |
18± 5.0 |
14± 6.4 |
4± 2.3 |
||
1250 |
84± 8.2 |
6± 2.6* |
11± 1.5 |
15± 5.7 |
6± 1.5 |
||
2500 |
51± 8.1* |
NT |
12± 3.5* |
13± 4.7* |
0 ± 0* |
||
5000 |
0 ± 0* |
NT |
5 ± 2.0* |
0 ± 0* |
0 ± 0* |
||
Positive controls, + S9 mix |
Positive controls |
B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
|
Concentration (µg/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
5.0 |
||
Mean No. of colonies/plate ± SD |
957 ± 93.6 |
254± 16.5 |
812± 66.4 |
250± 44.3 |
67± 3.1 |
||
Table 2. Test results of the experiment 2 with or without S9 mix for triethoxy(methyl)silane
With or without S9 mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (Mean of 3 replicate ± SD) |
||||
- |
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2urvA |
TA98 |
TA1537 |
||
128 ± 11.5 |
8 ± 1.5 |
13 ± 1.2 |
14 ± 2.5 |
7 ± 1.2 |
||
39.1 |
- |
4 ± 2.5 |
- |
- |
- |
|
78.1 |
- |
6 ± 0.6 |
- |
- |
- |
|
156 |
116 ± 7.8 |
8 ± 4.6 |
13 ± 2.0 |
17 ± 3.8 |
10 ± 4.4 |
|
313 |
98 ± 6.8 |
8 ± 6.7 |
12 ± 2.9 |
11 ± 4.2 |
6 ± 1.0 |
|
625 |
126 ± 14.8 |
6 ± 3.2 |
19 ± 3.5 |
12 ± 1.0 |
4 ± 0.0 |
|
1250 |
107 ± 12.5 |
4 ± 1.5* |
12 ± 3.5 |
12 ± 6.1 |
6 ± 1.5 |
|
2500 |
0 ± 0.0* |
- |
12 ± 2.9* |
5 ± 2.3* |
0 ± 0.0* |
|
5000 |
0 ± 0.0* |
- |
0 ± 0.0* |
0 ± 0.0* |
0 ± 0.0* |
|
Positive controls, – S9 mix |
Name |
AF2 |
NaN3 |
AF2 |
AF2 |
ICR-191 |
Concentration (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
|
Mean No. of colonies/plate ± SD |
638 ± 47.9 |
161 ± 3.2 |
70 ± 7.6 |
491 ± 31.2 |
1232 ± 27.8 |
|
+ |
0 |
118 ± 9.6 |
8 ± 1.5 |
22 ± 5.6 |
24 ± 9.9 |
7 ± 1.0 |
39.1 |
NT |
7 ± 2.5 |
NT |
NT |
NT |
|
78.1 |
NT |
8 ± 2.5 |
NT |
NT - |
NT |
|
156 |
127 ± 21.4 |
8 ± 1.5 |
14 ± 3.6 |
19 ± 2.5 |
7 ± 2.3 |
|
313 |
119 ± 13.7 |
8 ± 1.5 |
18 ± 9.9 |
23 ± 3.1 |
6 ± 3.2 |
|
625 |
123 ± 4.2 |
8 ± 2.6 |
15 ± 5.8 |
25 ± 4.2 |
8 ± 3.1 |
|
1250 |
114 ± 8.1 |
8 ± 2.9* |
14 ± 2.1 |
17 ± 3.5 |
6 ± 1.0 |
|
2500 |
52 ± 17.3* |
NT |
7 ± 2.1 |
8 ± 1.7* |
0 ± 0* |
|
5000 |
0 ± 0* |
NT |
9 ± 2.6* |
0 ± 0* |
0 ± 0* |
|
Positive controls, + S9 mix |
Name |
B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
Concentration (µg/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
5.0 |
|
Mean No. of colonies/plate ± SD |
937 ± 45.0 |
191 ± 13.0 |
776 ± 14.2 |
311 ± 24.0 |
97 ± 2.4 |
AF2: Furylfulamide
NaN3: sodium azide
ICR-191: 6-chloro-9-[3-(2-chloroethylamino)propylamino]-2-methoxyacridine dihydrochloride
B[a]P: Benzo(a)pyrene
2AA: 2-aminoanthracene
SD: standard deviation
*: Growth inhibition
NT: This concentration was not tested.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the Ames test the substance was not mutagenic in any of the five strains (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA) tested with and without metabolic activation up to 1250 µg/plate for TA1535 and 5000 µg/plate for other strains.
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