Registration Dossier
Registration Dossier
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EC number: 217-983-9 | CAS number: 2031-67-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro:
Gene mutation (Bacterial reverse mutation assay/ Ames test): S. typhimurium strains: TA 100, TA 98, TA 1535, TA 1537; and E. coli WP2 strain: Negative with and without metabolic activation (according to OECD TG 471).
Mammalian mutagenicity (mouse lymphoma L5178Y cell): Negative with and without metabolic activation (according to OECD TG 476).
In vitro cytogenicity (chinese hamster CHL/IU cell): Negative with and without metabolic activation (equivalent or similar to OECD TG 473).
Link to relevant study records
- 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
- 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
- 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. - Target gene:
- trp operon and his operon
- 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 - 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.
- 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 - 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.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Nov 2011 - 23 Mar 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- 200 metaphases scored, limited data on historical data provided (no values and range given), cell proliferation used as parameter for cytotoxicity (no RPD or RICC values given), no C-charts or X-bar charts provided
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- 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 - Species / strain / cell type:
- mammalian cell line, other: CHL/IU
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Health Science Research Resources Bank, Sennan-city, Japan
- Suitability of cells: yes
- Modal number of chromosomes: 25
- Cell cycle length, doubling time or proliferation index: within 15 - 20 h
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: MEM supplemented with 10 v/v% bovine serum
- Properly maintained: yes - 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:
- Pre-experiment for cell proliferation inhibition test:
Short term treatment: 6 h exposure and 18 h fixation with and without S9 mix with concentrations of 14.1, 28.1, 56.3, 113, 225, 450, 900 and 1800 μg/mL, and
Continued treatment: 24 h and 48 h exposure without S9 mix with 14.1, 28.1, 56.3, 113, 225, 450, 900 and 1800 μg/mL
Main experiment:
450, 900 and 1800 μg/mL respective for short-term treatment (6 h) with and without metabolic activation and continued treatments (24h, 48h) without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solibility of the test substance in water, DMSO was selected as vehicle. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
- Cell density at seeding (if applicable): 2 * 10000 cells/mL at seeding. After 3 days culture, the medium was changed and the cells were exposed to the test substance.
DURATION
- Exposure duration: 6 h for short-term treatment; 24 h and 48 h for continuted treatments
SPINDLE INHIBITOR (cytogenetic assays): 10 μg/mL Colcemid
STAIN: Giemsa
NUMBER OF REPLICATIONS: duplicates
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): 200 - Evaluation criteria:
- A test substance was considered positive in the chromosoe aberration test if a) it induced 10% and more frequency of structural and numerical abnormality of chromosome, and b) dose responsibility and reproducibility was confirmed.
A test substance was considered false positive if it induced between 5 and 10% frequency of structual and numerical abnormality of chromosome.
A test substance was considered negative if it induced less tha 5% frequency of structual and numerical abnormality of chromosome. - Statistics:
- Mean values and standard deviations were calculated.
- Key result
- Species / strain:
- other: CHL/IU
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation was not observed at the end of the study, although it was observed above 900 μg/mL at the beginning of the study in all test system with or without metabolic activation.
RANGE-FINDING/SCREENING STUDIES:
The highest concentration was selected based on the results of cell groth inhibition test. The preliminary test was performed at 14.1, 28.1, 56.3, 113, 225, 450, 900, and 1800 μg/mL (equals to 10 mM) with/without S9 for short term treatmen t(6h) and without S9 mix for 24 h and 48 h treatments. Above 900 μg/mL, precipitate was observed at the beginning of the study. Since the minium inhibitionon the cell-growth ratio was observed, the highest dose was determined as 1800 μg/mL.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: not provided
- Negative (solvent/vehicle) historical control data: not provided
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: cell-growth ratio - Conclusions:
- Under the experimental conditions of the in vitro chromosome aberration test, the test substance did not induce structural chromosomal aberrations in Chinese hamster lung fibroblasts with and without metabolic activation.
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP. The restriction was that the test concentration was insufficient considering no duplicates.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- Insufficient test concentrations / no duplicates
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Target gene:
- TK locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Fischer's medium for leukemic cells of mice with 10% horse serum and sodium pyruvate.
- Properly maintained: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- mouse liver S9
- Test concentrations with justification for top dose:
- Experiment I
with and without metabolic activation: 0.1, 0.2, 0.4, 0.8 and 1.6 μL/mL
Experiment II
without metabolic activation: 0.4, 0.8, 1.6 and 2.4 μL/mL
with metabolic activation: 0.4, 0.8, 1.6, 2.4 and 3.2 μL/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 0.1 and 0.5 µL/mL (without metabolic activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: dimethylnitrosamine
- Remarks:
- 0.1 and 0.5 µL/mL (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): 10 days
- Fixation time (start of exposure up to fixation or harvest of cells): 13 days
SELECTION AGENT (mutation assays): BUdR (bromodeoxyuridine)
NUMBER OF REPLICATIONS: triplicates each of two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Increase of mutation frequency in a dose-dependent manner in comparison with historical control range.
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 50% growth inhibition at -S9 2.4 µL/mL; +S9: 3.2 µL/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data - Conclusions:
- Interpretation of results: negative with and without metabolic activation.
In an in vitro mouse lymphoma L5178Y cells gene mutation test equivalent or similar to OECD 476 and not compliant with GLP, the test substance was found to be non-mutagenic. Appropriate solvent and positive controls were included and gave expected results.
Referenceopen allclose all
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.
Table 1. Test results for triethoxy(methyl)silane
Test item |
Concentration |
Cell-growth ratio |
Aberrant cells |
||
|
in µg/mL |
in % |
incl. gaps (%) |
excl. gaps (%) |
|
Structural aberrant cells |
Nummeral aberrant cells |
||||
Exposure period 6 h, with S9 mix |
|||||
DMSO |
10% (v/v) |
100 |
0.0 |
0.0 |
0.5 |
CP |
14 |
105 |
78.5 |
78.5 |
0.0 |
Test substance |
450 |
89 |
1.0 |
1.0 |
0.5 |
900 |
95 |
0.0 |
0.0 |
0.5 |
|
1800 |
89 |
0.5 |
0.5 |
0.0 |
|
Exposure period 6 h, without S9 mix |
|||||
DMSO |
10% (v/v) |
100 |
0.0 |
0.0 |
0.5 |
MMC |
0.075 |
109 |
22.5 |
22.5 |
0.5 |
Test substance |
450 |
100 |
0.0 |
0.0 |
0.5 |
900 |
104 |
0.0 |
0.0 |
0.0 |
|
1800 |
104 |
0.0 |
0.0 |
0.5 |
|
Exposure period 24 h, without S9 mix |
|||||
DMSO |
10% (v/v) |
100 |
0.5 |
0.5 |
0.0 |
MMC |
0.050 |
115 |
29.5 |
28.5 |
0.0 |
Test substance |
450 |
94 |
0.0 |
0.0 |
0.0 |
900 |
94 |
1.0 |
1.0 |
0.0 |
|
1800 |
105 |
0.0 |
0.0 |
0.0 |
|
Exposure period 48 h, without S9 mix |
|||||
DMSO |
10% (v/v) |
100 |
0.5 |
0.5 |
0.0 |
MMC |
0.050 |
115 |
29.5 |
28.5 |
0.0 |
Test substance |
450 |
94 |
0.0 |
0.0 |
0.0 |
900 |
94 |
1.0 |
1.0 |
0.0 |
|
1800 |
105 |
0.0 |
0.0 |
0.0 |
|
Positive controle:
MMC: Mitomycin C
CP: Cyclophosphamide
Table 1: Experiment I - 4 h exposure
Concentration |
Metabolic Activation |
Cloning efficiency [%] |
Relative Total Growth [%] |
Mutants per 1E+06 surviving cells |
Mutation factor |
solvent control |
- |
100.00 |
100.00 |
3.30 |
1.00 |
negative control |
- |
92.90 |
80.30 |
4.20 |
1.27 |
0.1 |
- |
93.30 |
103.70 |
10.90 |
3.30 |
0.2 |
- |
78.40 |
71.10 |
15.50 |
4.70 |
0.4 |
- |
92.50 |
58.50 |
6.40 |
1.94 |
0.8 |
- |
109.80 |
80.20 |
3.90 |
1.18 |
1.6 |
- |
79.60 |
51.50 |
4.90 |
1.48 |
EMS, 0.5 |
- |
35.30 |
12.90 |
485.60 |
147.15 |
solvent control |
+ |
100.00 |
100.00 |
6.50 |
1.97 |
negative control |
+ |
95.00 |
84.80 |
3.00 |
0.91 |
0.1 |
+ |
67.50 |
75.00 |
12.10 |
3.67 |
0.2 |
+ |
60.60 |
64.70 |
8.30 |
2.52 |
0.4 |
+ |
85.80 |
68.10 |
13.60 |
4.12 |
0.8 |
+ |
91.80 |
89.60 |
14.40 |
4.36 |
1.6 |
+ |
100.30 |
50.70 |
7.50 |
2.27 |
DMN, 0.5 |
+ |
12.90 |
2.90 |
643.90 |
195.12 |
Table 2: Experiment II - 4 h exposure
Concentration |
Metabolic Activation |
Cloning efficiency [%] |
Relative Total Growth [%] |
Mutants per 1E+06 surviving cells |
Mutation factor |
solvent control |
- |
100.00 |
100.00 |
16.00 |
4.85 |
negative control |
- |
99.30 |
81.60 |
18.00 |
5.45 |
0.4 |
- |
66.90 |
84.40 |
18.30 |
5.55 |
0.8 |
- |
32.50 |
50.00 |
27.60 |
8.36 |
1.6 |
- |
56.60 |
57.80 |
8.80 |
2.67 |
2.4 |
- |
85.10 |
48.10 |
8.90 |
2.70 |
EMS, 0. |
- |
82.10 |
61.30 |
64.50 |
19.55 |
solvent control |
+ |
100.00 |
100.00 |
13.00 |
3.94 |
negative control |
+ |
70.40 |
67.10 |
37.30 |
11.30 |
0.4 |
+ |
121.10 |
84.10 |
12.00 |
3.64 |
0.8 |
+ |
118.80 |
122.90 |
17.00 |
5.15 |
1.6 |
+ |
115.00 |
85.70 |
19.20 |
5.82 |
2.4 |
+ |
116.00 |
111.50 |
12.10 |
3.67 |
3.2 |
+ |
125.40 |
45.00 |
15.00 |
4.55 |
DMN, 0.1 |
+ |
29.10 |
8.90 |
414.50 |
125.61 |
EMS Ethyl methane sulphonate
DMN Dimethylnitrosamine
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Studies were chosen as key when the available study was of relevance and sufficient quality for classification, labelling and risk assessment. Other available data are included as supporting studies.
The key bacterial mutagenicity study on triethoxy(methyl)silane was conducted in compliance with GLP and according to OCED TG 471 (METI, 2012). No evidence for a test-substance related increase in the number of revertants was observed in Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2uvrA strain. The strains were treated with doses of 0.39 to 5.0 mg/plate with and without metabolic activation system. Appropriate positive and solvent controls were included and gave expected results. Under the conditions of this study, triethoxy(methyl)silane was concluded to be non-mutagenic in the Salmonella typhimurium strains(METI, 2012). This conclusion was further supported in two additional bacterial reverse mutation assays where no test-substance related increase in the number of revertants was observed in Salmonella typhimurium TA 98, TA100, TA1535, TA1537 and TA1538, treated with 0.1 to 5.0 mg/plate with and without metabolic activation system (Hazelton France, 1992e) or Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae, treated with doses of 0.001 to 5 µL/plate with and without metabolic activation system (Litton Bionetics, 1978), respectively.
The key in vitro cytogenicity study on triethoxy(methyl)silane was conducted in compliance with GLP and according to OECD TG 473 (METI, 2012). Triethoxy(methyl)silane did not cause a statistically significant dose-related increase in chromosome aberrations in Chinese hamster CHL/IU cells with or without metabolic activation. The test substance was therefore considered non-clastogenic in CHL/IU cells. Appropriate positive and solvent controls were included and gave expected results (METI, 2012). This conclusion was supported in an additional chromosome aberration test (Litton Bionetics, 1979). In the supporting study, no test-substance related increase in chromosome aberrations in mouse lymphoma L5178Y cells with or without metabolic activation were observed.
A key mammalian cell gene mutation study equivalent or similar to OECD TG 476 and which was conducted prior to the commencement of GLP is available for the registered substance. Triethoxy(methyl)silane was tested in the mouse lymphoma L5178Y cells in the absence and presence of metabolic activation. The cultures selected for cloning were treated with doses up to 2.4 µL/ml in the absence and 3.2 µL/ml in the presence of metabolic activation and exhibited no mutagenic potential in mouse lymphoma L5178Y cells. Appropriate positive and solvent controls were included and gave expected results (Litton Bionetics, 1978).
In vivo testing is not required as no evidence for genetic toxicity was found in the in vitro studies.
Justification for classification or non-classification
Based on the available in vitro and in vivo data on mutagenicity of the registered substance, triethoxy(methyl)silane is not classified for mutagenicity according to Regulation (EC) 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.
