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EC number: 220-941-2 | CAS number: 2943-75-1
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 Escherichia coli WP2 uvrA (draft OECD TG 471) (MA Bioservices, 1998).
Cytogenicity in mammalian
cells: negative with and without metabolic activation in Chinese hamster
ovary cells (OECD TG 473) (MA Bioservices 1997).
Mutagenicity in mammalian
cells: negative in mouse lymphoma L5178Y cells (OECD TG 476) (BSL
Bioservice, 2012).
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:
- 1997.11.14-1997.12.09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD draft guidelines 471 and 472 (1995)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- 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:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- 75, 200, 600, 1800 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: based on sponsor's request and compatibility with the target cells - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 1.0 µg/plate
- Remarks:
- TA98, TA100, TA1535, TA1537, WP2 uvrA with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 and TA1535 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without metabolic activation 75 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without metabolic activation 1000 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
ACTIVATION: S9 mix contained glucose-6-phosphate and NADP as co-factors. 0.5 ml of S9 mix containing 10% S9 was added to agar, bacterial suspension and test substance to a total volume of 2.65, giving a final concentration of approximately 1% S9.
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 - 72 hours
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: condition of background lawn - Evaluation criteria:
- A result is positive if it causes a dose related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article. This would be an increase of at least 3-fold of the solvent control for TA1535 and TA1537 and a 2-fold increase of the solvent control for TA98, TA100 and WP2 uvrA
- Statistics:
- None available
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Conclusions:
- Triethoxy(octyl)silane has been tested for mutagenicity to bacteria in a study conducted according to OECD draft guidelines 471 and in compliance with GLP. No evidence of a substance related increase in the number of revertants was observed with or without activation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in the initial or the repeat experiment, both of which used the preincubation method. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994.11.07 - 1997.12.24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: McCoy's 5A medium supplemented with 10% FBS; 2mM L-glutamine; 100 units/ml penicillin and 100 µg/ml streptomycin
- Properly maintained: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S-9
- Test concentrations with justification for top dose:
- 0.016 - 157 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: no information provided - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- used with S9 metabolic activation 30 µg/ml
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N-nitro-N-nitrosoguanidine (MNNG) dosed at 2 µg/ml
- Remarks:
- used without S9 activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 6 hours with and without S9 metabolic activation or up to 24 and 48 hours without S9
- Expression time (cells in growth medium): 18 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): 5% Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 200 per dose level
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cell growth inhibition - Statistics:
- Fisher's exact test and the Cochran-Armitage test
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 20 µg/ml (-MA); 50 µg/ml (+MA)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
COMPARISON WITH HISTORICAL CONTROL- Conclusions:
- Triethoxy(octyl)silane has been tested in a reliable in vitro cytogenetic assay according to OECD TG 473 and in compliance with GLP. The test substance did not induce statistically and biologically significant increases in the chromosomal aberration frequency of CHO (Chinese hamster ovary) cells. It is concluded that the test substance is negative for the induction of chromosome aberrations (not clastogenic) in vitro under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-12-21 to 2012-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: IWGT Recommendations
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-expt I: 0.2, 0.5, 2.5, 5.0, 7.5 and 10.0 mM (+/-MA); Pre-expt II: 0.01, 0.1, 1.0, 2.0, 5.0, 10.0 mM (-MA, 24 h exp); Expt I: 0.1, 0.2, 0.5, 1.0, 2.5, 5.0, 7.5 and 10.0 mM (+/-MA); Expt II: 0.15, 0.3, 0.7, 2.0, 4.0, 6.0, 8.0 and 10.0 mM (+MA); 0.001, 0.002, 0.005, 0.01, 0.02, 0.05, 0.10 and 0.20 mM (-MA)
- Vehicle / solvent:
- THF was used as solvent (0.35% THF v/v in the samples). To reach a final concentration of 0.35% THF v/v in the samples the test item stock solution was diluted in RPMI + 5% HS for short-term exposure or RPMI + 7.5% HS for long-term exposure. After adding the THF stock solution to cell culture medium precipitate formed.
The solvent was compatible with the survival of the cells and the activity of the S9 mix. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation 3.5 µg/mL
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation 200 µg/mL and 300 µg/mL
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation 10 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: dissolved in THF (0.35% THF v/v in the samples)
DURATION: 4 h (short-term exposure), 24 h (long-term exposure)
Expression time (cells in growth medium): 48 h
Selection time (if incubation with selection agent): about 14 days
SELECTION AGENT ( mutation assay) 5 µg/ml trifluorothymidine
NUMBER OF REPLICATIONS: two separate experiments (I+II) with single exposure; cells were seeded in 4 plates and evaluated
NUMBER OF CELLS SEEDED: 2000 cells per well
DETERMINATION OF CYTOTOXICITY: relative total growth (RTG)
ACTIVATION: S9 mix contained glucose-6-phosphate and NADP as co-factors, and sufficient S9 to give a final protein concentration in the cultures of 0.75 mg/ml - Evaluation criteria:
- The test item is considered mutagenic if following criteria are met:
- The induced mutant frequency meets or exceeds the Global Evaluation factor (GEF) of 126 per 10^6 cells
- A dose-dependent increase in mutant frequency is detected.
Besides, combined with a positive effect in the mutant frequency, an increased occurrence of small colonies (≥40% of total colonies) is an indication for potential clastogenic effects and/or chromosomal aberrations.
According to the OECD test guidelines, the biological relevance is considered first for the interpretation of results. Statistical methods might be used as an aid in evaluation the test result.
A test item is considered to be negative if the induced mutant frequency is below the GEF and the trend test is negative. - Statistics:
- The non-parametric Mann-Whitney test is applied to the mutation data to prove the dose groups for any significant difference in mutant frequency compared to the negative /solvent controls.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- RTG of 14.6% and 9.7% without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Triethoxy(octyl)silane has been tested for mutagenicity to mammalian cells in a reliable study conducted according to OECD TG 476 and in compliance with GLP. No biologically relevant increase in mutation rate was found in mouse lymphoma L5178Y cells with or without metabolic activation in either the initial or the repeat experiment, up to limit and cytotoxic concentrations. The global evaluation factor was not exceeded at any concentration. In addition, colony sizing showed no clastogenic effects in either experiment. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test.
- Executive summary:
The test item triethoxy(octyl)silane was assessed for its potential to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y.
The selection of the concentrations used in the main experiments was based on data from the pre-experiments. In Experiment I 10.0 mM (with and without metabolic activation) was selected as the highest concentration. In Experiment II 10.0 mM (with metabolic activation) and 0.20 mM (without metabolic activation) were selected as the highest concentrations. Experiment I with and without metabolic activation and Experiment II with metabolic activation were performed as a 4 h short-term exposure assay. Experiment II without metabolic activation was performed as a 24 h long-term exposure assay.
THF was used as solvent (0.35% THF v/v in the samples). After adding the THF stock solution to cell culture medium precipitate formed.
The test item was investigated at the following concentrations:
Experiment I
with and without metabolic activation:
0.1, 0.2, 0.5, 1.0, 2.5, 5.0, 7.5 and 10.0 mM
Experiment II
with metabolic activation:
0.15, 0.3, 0.7, 2.0, 4.0, 6.0, 8.0 and 10.0 mM
and without metabolic activation:
0.001, 0.002, 0.005, 0.01, 0.02, 0.05, 0.10 and 0.20 mM
Precipitation of the test item was noted in Pre-experiment Iwith and without metabolic activation, Pre-experiment II without metabolic activation, Experiment I with and without metabolic activation and in Experiment II with metabolic activation.
In Experiment I with metabolic activation the relative total growth (RTG) was 74.3% for the highest concentration (10.0 mM) evaluated. At two concentrations (1.0 mM and 2.5 mM) growth inhibition was observed with a RTG of 63.7% and 67.1%, respectively. However, considering all evaluated concentrations this effect showed no concentration relationship. The highest concentration evaluated without metabolic activation was 10.0 mM with a RTG of 14.6%. The Experiment without metabolic activation displayed a concentration related decrease in RTG starting at 1.0 mM with a RTG of 49.2%.
In Experiment II with metabolic activation the relative total growth (RTG) was 76.4% for the highest concentration (10.0 mM) evaluated. At two concentrations (2.0 mM and 6.0 mM) growth inhibition was observed with a RTG of 42.3% and 58.9%, respectively. However, considering all evaluated concentrations this effect showed no concentration relationship. The highest concentration evaluated without metabolic activation was 0.20 mM with a RTG of 0.9%. Due to high cytotoxicity the highest concentration was not considered for evaluation of mutagenicity. Experiment II without metabolic activation displayed a concentration related decrease in RTG starting at 0.1 mM with a RTG of 16.8%.
In Experiments I and II no biologically relevant increase of mutants were found after treatment with the test item (with and without metabolic activation).The Global Evaluation Factor (GEF; defined as the mean of the negative/vehicle mutant frequency plus one standard deviation; data gathered from ten laboratories) was not exceeded by the induced mutant frequency at any concentration.
No dose-response relationship was observed in Experiment I with metabolic activation and in Experiment II with and without metabolic activation. In Experiment I without metabolic activation a dose-response relationship was observed in the higher concentrations.
Additionally, in Experiments I and II colony sizing showed no clastogenic effects induced by the test item under the experimental conditions (with and without metabolic activation).
EMS, MMS and B[a]P were used as positive controls and showed distinct and biologically relevant effects in mutation frequency. Additionally, MMS and B[a]P significantly increased the number of small colonies, thus proving the efficiency of the test system to indicate potential clastogenic effects.
This study is classified as acceptable. This study satisfies the requirements for Test Guidelines OPPTS 870.5300, OECD 476 for in vitro mutagenicity (mammalian forward mutation) data.
Referenceopen allclose all
Table 1 Experiment 1 Revertants per plate - preincubation (mean of 3 plates)
Treatment µg/plate |
TA98 | TA 98 |
TA100 | TA 100 |
TA1535 | TA 1535 |
TA1537 | TA 1537 |
WP2 uvrA |
WP2 uvrA |
-S9 |
+S9 |
-S9 |
= S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+ S9 |
|
Solvent control |
19 |
37 |
138 |
151 |
8 |
9 |
6 |
5 |
16 |
17 |
75 |
20 |
30 |
139 |
148 |
11 |
14 |
6 |
7 |
21 |
24 |
200 |
23 |
38 |
123 |
165 |
10 |
13 |
6 |
5 |
18 |
18 |
600 |
21 |
37 |
111 |
160 |
10 |
12 |
7 |
8 |
17 |
18 |
1800 |
25 |
31 |
132 |
143 |
9 |
10 |
4 |
6 |
18 |
17 |
5000 |
20 |
26 |
125 |
133 |
11 |
12 |
5 |
6 |
13 |
14 |
Positive control |
1037 |
916 |
605 |
790 |
551 |
112 |
775 |
87 |
437 |
511 |
Table 2 Experiment 2 Revertants per plate - preincubation (mean of 3 plates)
Treatment µg/plate |
TA98 | TA 98 |
TA100 | TA 100 |
TA1535 | TA 1535 |
TA1537 | TA 1537 |
WP2 uvrA | WP2 uvrA |
-S9 |
+S9 | -S9 |
+ S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+ S9 |
|
Solvent Control |
14 |
25 |
119 |
129 |
8 |
13 |
8 |
8 |
18 |
22 |
75 |
15 |
23 |
117 |
134 |
5 |
12 |
6 |
5 |
18 |
22 |
200 |
12 |
18 |
111 |
109 |
7 |
9 |
4 |
6 |
14 |
17 |
600 |
10 |
23 |
112 |
123 |
9 |
9 |
5 |
9 |
12 |
14 |
1800 |
12 |
23 |
90 |
119 |
7 |
8 |
6 |
8 |
15 |
14 |
5000 |
12 |
24 |
94 |
119 |
9 |
9 |
3 |
6 |
14 |
10 |
Positive control |
736 |
975 |
500 |
921 |
457 |
94 |
719 |
87 |
438 |
358 |
Chromosome aberration assay
Treatment µg/ml |
S9 activation |
Treatment /Harvest Time |
Mitotic index |
Metaphase cells scored for aberrations |
Cells with aberrations | Cells with aberrations |
Numberical | Structural |
|||||
Negative control |
- |
24 |
7.2 |
200 |
2.5 |
0.5 |
Solvent control |
- |
6/24 |
6.1 |
200 |
2.5 |
0.5 |
A-137 |
|
|
|
|
|
|
8.5 |
- |
6/24 |
6.8 |
200 |
1.0 |
1.0 |
11.3 |
- |
6/24 |
8.2 |
200 |
2.0 |
0.5 |
15 |
- |
6/24 |
8.5 |
200 |
0.5 |
2.0 |
20 |
- |
6/24 |
3.9 |
155 |
0.6 |
0.0 |
Positive control |
- |
6/24 |
5.2 |
200 |
1.5 |
27.0** |
|
|
|
|
|
|
|
Negative control |
+ |
24 |
10.9 |
200 |
3.0 |
0.5 |
Solvent control |
+ |
6/24 |
8.2 |
200 |
5.0 |
0.5 |
A-137 |
|
|
|
|
|
|
21.3 |
+ |
6/24 |
9.5 |
200 |
5.0 |
0.5 |
28.3 |
+ |
6/24 |
9.4 |
200 |
5.0 |
0.0 |
37.6 |
+ |
6/24 |
6.6 |
200 |
8.0 |
1.5 |
50 |
+ |
6/24 |
3.2 |
200 |
3.5 |
1.0 |
Positive control |
+ |
6/24 |
3.0 |
200 |
8.5 |
43.0** |
|
|
|
|
|
|
|
Negative control |
- |
24 |
12.1 |
200 |
0.5 |
0.5 |
Solvent control |
- |
24/24 |
9.1 |
200 |
0.0 |
1.0 |
A-137 |
|
|
|
|
|
|
8.5 |
- |
24/24 |
7.6 |
200 |
0.0 |
1.0 |
11.3 |
- |
24/24 |
11.6 |
200 |
1.0 |
1.0 |
15 |
- |
24/24 |
11.7 |
200 |
1.5 |
1.0 |
20 |
- |
24/24 |
1.7 |
37 |
0.0 |
0.0 |
Positive control |
- |
24/24 |
5.9 |
200 |
1.5 |
20.5** |
|
|
|
|
|
|
|
Negative control |
- |
48 |
5.0 |
200 |
0.0 |
0.5 |
Solvent control |
- |
48/48 |
4.0 |
200 |
0.0 |
1.5 |
A-137 |
|
|
|
|
|
|
8.5 |
- |
48/48 |
4.1 |
200 |
0.0 |
2.0 |
11.3 |
- |
48/48 |
3.1 |
200 |
0.0 |
0.0 |
15 |
- |
48/48 |
2.0 |
200 |
1.0 |
0.0 |
20 |
- |
48/48 |
2.0 |
200 |
0.5 |
2.0 |
Positive control |
- |
48/48 |
2.2 |
200 |
1.0 |
18.0** |
** Aberration frequency statistically significant
Pre-experiment for toxicity with and without metabolic activation
Concentration (mM) |
Number of cells 4 h after treatment |
Number of cells 4 h after treatment |
Number of cells 24 h after treatment |
Number of cells 24 h after treatment |
Number of cells 48 h after treatment |
Number of cells 48 h after treatment |
Suspension growth |
Suspension growth |
Relative suspension growth |
Relative suspension growth |
|
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
Negative control |
271000 |
278000 |
946000 |
948000 |
1600000 |
1570000 |
15.1 |
14.9 |
89.8 |
103.6 |
Negative control |
307000 |
356000 |
1050000 |
1150000 |
1510000 |
1540000 |
15.9 |
17.7 |
94.1 |
123.3 |
Solvent control |
307000 |
256000 |
104000 |
807000 |
1560000 |
1570000 |
16.2 |
12.7 |
100.0 |
100.0 |
Solvent control |
339000 |
313000 |
112000 |
101000 |
1560000 |
1590000 |
17.5 |
16.1 |
- |
- |
0.2 |
284000 |
271000 |
77000 |
593000 |
1540000 |
1480000 |
11.9 |
8.8 |
70.4 |
61.1 |
0.5 |
307000 |
252000 |
876000 |
377000 |
1490000 |
1190000 |
13.1 |
4.5 |
77.5 |
31.2 |
2.5 |
289000 |
220000 |
728000 |
186000 |
1620000 |
637000 |
11.8 |
1.9 |
70.0 |
13.3 |
5.0 |
316000 |
225000 |
798000 |
137000 |
1550000 |
286000 |
12.4 |
0.9 |
73.4 |
6.0 |
7.5 (P) |
303000 |
271000 |
650000 |
293000 |
1590000 |
850000 |
10.3 |
2.6 |
61.3 |
17.8 |
10.0 (P) |
305000 |
244000 |
728000 |
183000 |
1580000 |
481000 |
11.5 |
1.4 |
68.3 |
10.0 |
Summary: Experiment 1 and 2 with metabolic activation
|
Treatment (mM) |
RTG (%) |
MF (mutants/106cells) |
IMF (mutants/106cells) |
Precipitate |
|
Negative control |
103.5 |
125.6 |
- |
- |
Exp. 1 |
Negative control |
98.1 |
- |
- |
- |
|
Solvent control |
100.0 |
135.2 |
- |
- |
|
Solvent control |
- |
- |
- |
- |
|
0.1 |
72.3 |
142.3 |
7.2 |
- |
|
0.2 |
73.5 |
143.3 |
8.1 |
- |
|
0.5 |
84.9 |
97.1 |
-38.1 |
- |
|
1.0 |
63.7 |
182.8 |
47.6 |
- |
|
2.5 |
67.1 |
144.4 |
9.2 |
- |
|
5.0 |
87.2 |
117.6 |
-17.6 |
- |
|
7.5 |
78.1 |
154.8 |
19.6 |
- |
|
10.0 |
74.3 |
130.3 |
-4.8 |
+ |
|
Positive control |
38.4 |
918.4 |
783.2 |
- |
|
|
|
|
|
|
|
Treatment (mM) |
RTG (%) |
MF (mutants/106cells) |
IMF (mutants/106cells) |
Precipitate |
|
Negative control |
98.9 |
116.5 |
- |
- |
|
Negative control |
111.8 |
- |
- |
- |
Exp. 2 |
Solvent control |
100.0 |
116.7 |
- |
- |
|
Solvent control |
|
- |
- |
- |
|
0.15 |
111.4 |
105.1 |
-11.6 |
- |
|
0.3 |
96.2 |
131.1 |
14.4 |
- |
|
0.7 |
75.7 |
128.5 |
11.8 |
- |
|
2.0 |
42.3 |
220.5 |
103.8 |
- |
|
4.0 |
72.7 |
138.8 |
22.2 |
- |
|
6.0 |
58.9 |
170.6 |
53.9 |
- |
|
8.0 |
74.1 |
134.6 |
17.9 |
- |
|
10.0 |
76.4 |
154.9 |
38.2 |
+ |
|
Positive control |
50.5 |
1141.0 |
1024.3 |
- |
MF = Mutant Frequency
IMF = induced mutant frequency
RTG = relative total growth
Summary: Experiment 1 and 2 without metabolic activation
|
Treatment (mM) |
RTG (%) |
MF (mutants/106cells) |
IMF (mutants/106cells) |
Precipitate |
|
Negative control |
122.0 |
142.0 |
- |
- |
Exp. 1 |
Negative control |
129.6 |
- |
- |
- |
|
Solvent control |
100.0 |
144.3 |
- |
- |
|
Solvent control |
- |
- |
- |
- |
|
0.1 |
100.3 |
177.2 |
32.9 |
- |
|
0.2 |
87.3 |
157.4 |
13.0 |
- |
|
0.5 |
98.4 |
186.0 |
41.6 |
- |
|
1.0 |
49.2 |
190.1 |
45.7 |
- |
|
2.5 |
37.8* |
179.4 |
35.1 |
- |
|
5.0 |
37.2 |
179.3 |
35.0 |
- |
|
7.5 |
17.1 |
224.1 |
79.8 |
+ |
|
10.0 |
14.6 |
264.7 |
120.4 |
+ |
|
Positive control |
75.1 |
817.6 |
673.2 |
- |
|
Positive control 2 |
85.2 |
564.1 |
419.7 |
- |
|
|
|
|
|
|
|
Treatment (mM) |
RTG (%) |
MF (mutants/106cells) |
IMF (mutants/106cells) |
Precipitate |
|
Negative control |
145.4 |
110.6 |
- |
- |
|
Negative control |
122.8 |
- |
- |
- |
Exp. 2 |
Solvent control |
100.0 |
109.3 |
- |
- |
|
Solvent control |
- |
- |
- |
- |
|
0.001 |
114.6 |
108.6 |
-0.8 |
- |
|
0.002 |
99.3 |
94.7 |
-14.6 |
- |
|
0.005 |
103.4 |
120.0 |
10.6 |
- |
|
0.01 |
62.1 |
121.8 |
12.5 |
- |
|
0.02 |
82.5 |
160.0 |
50.6 |
- |
|
0.05 |
98.6 |
108.4 |
-0.9 |
- |
|
0.10 |
16.8 |
173.0 |
63.6 |
- |
|
0.20 |
0.9 |
119.1 |
9.7 |
- |
|
Positive control 1 |
21.3 |
2373.6 |
2264.2 |
- |
|
Positive control 2 |
14.7 |
1826.6 |
1717.3 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data are available from reliable in vitro studies on mutagenicity to bacterial and mammalian cells, and cytogenicity to mammalian cells. Where there was more than one result for an endpoint, the most reliable study was chosen as key study.
Triethoxy(octyl)silane has been tested for mutagenicity to bacteria in a study conducted according to OECD draft Guideline 471 and in compliance with GLP (MA Bioservices, 1998). No evidence of a substance related increase in the number of revertants was observed with or without activation in TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA in the initial or the repeat experiment, both of which used the preincubation method. No toxicity to bacteria was observed up to limit concentrations. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test. The result obtained in this study is supported by two older studies; one of these tested Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 (BRRC, 1991) with and without metabolic activation, the other tested only strains TA 97, TA 98 and TA 100 (Kenelly, 1988), with and without metabolic activation. No evidence of test substance induced increase in the number of revertants was observed in either of the supporting studies.
Triethoxy(octyl)silane has been tested in a reliable in vitro cytogenetic assay according to OECD TG 473 and in compliance with GLP (MA Bioservices 1997). The test substance did not induce statistically and biologically significant increases in the chromosomal aberration frequency of CHO (Chinese hamster ovary) cells. No cytotoxicity was observed up to limit concentrations. 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 (not clastogenic) in vitro under the conditions of the test.
Triethoxy(octyl)silane has been tested for mutagenicity to mammalian cells in a reliable study conducted according to OECD TG 476 and in compliance with GLP (BSL Bioservice, 2012). No biologically relevant increase in mutation rate was found in mouse lymphoma L5178Y cells with or without metabolic activation in either the initial or the repeat experiment, up to limit and cytotoxic concentrations. The global evaluation factor was not exceeded at any concentration. In addition, colony sizing showed no clastogenic effects in either experiment. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test.
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 genotoxicity data, triethoxy(octyl)silane is not classified for mutagenicity according to Regulation (EC) No 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.
