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EC number: 921-774-4 | CAS number: 13763-19-4
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2006-08-16 to 2006-09-17
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Trimethoxysilane
- EC Number:
- 219-637-2
- EC Name:
- Trimethoxysilane
- Cas Number:
- 2487-90-3
- Molecular formula:
- C3H10O3Si
- IUPAC Name:
- trimethoxysilane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: CHO cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 152.5 to 1220 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility of the test article and compatibility with target cells.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- (with activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 16 - 24 hours
- Exposure duration: 4 - 20 hours (-MA), 4 hours (+MA)
NUMBER OF REPLICATIONS: 2 flasks per concentration
DETERMINATION OF CYTOTOXICITY
- Method: Cell growth inhibition relative to the solvent control
- Evaluation criteria:
- Toxicity based on cell growth inhibition relative to solvent control.
The number and types of aberrations found, % aberrant cells in the total population of cells examined, and mean aberrations per cell were calculated and reported for each treatment group.
The test article was considered to induce a positive response when the percentage of cells with aberrations is increased in a dose-responsive manner with one or more concentrations being statistically significant (p≤0.05). - Statistics:
- Fisher's exact test was used to compare pairwise the percent aberrant cells of each treatment group with that of the solvent control. In the event of a positive Fisher's Exact test at any test article dose level, the Cochran-Armitage test was used to measure dose-responsiveness.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- other: positive structural, negative numerical
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1220 µg/ml (4 hour group)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1220 µg/ml (4 hour group)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Preliminary toxicity test using Trimethoxysilane in CHO cells with and without S9 metabolic activation (4 hour treatment / 16 hour recovery)
|
- MA |
+ MA |
- MA |
||||||
|
4 hour treatment / 16 hour recovery |
20 hour continuous treatment) |
|||||||
Treatment μg/ml |
Cell Viability (%) |
Cell Growth Index (%) * |
Cell Growth Inhibition (%) ** |
Cell Viability (%) |
Cell Growth Index (%) * |
Cell Growth Inhibition (%) ** |
Cell Viability (%) |
Cell Growth Index (%) * |
Cell Growth Inhibition (%) ** |
DMSO |
98 |
100 |
- |
98 |
100 |
- |
100 |
100 |
- |
0.122 |
99 |
95 |
5 |
100 |
89 |
11 |
99 |
86 |
14 |
0.366 |
99 |
79 |
21 |
100 |
96 |
4 |
99 |
92 |
8 |
1.22 |
100 |
82 |
18 |
97 |
97 |
3 |
100 |
85 |
15 |
3.66 |
97 |
76 |
24 |
99 |
80 |
20 |
97 |
87 |
13 |
12.2 |
99 |
78 |
22 |
97 |
81 |
19 |
95 |
86 |
14 |
36.6 |
98 |
67 |
33 |
98 |
86 |
14 |
96 |
99 |
1 |
122 |
98 |
63 |
37 |
100 |
98 |
2 |
97 |
94 |
6 |
366 |
99 |
68 |
32 |
99 |
78 |
22 |
98 |
87 |
13 |
1220 |
93 |
41 |
59 |
95 |
42 |
58 |
91 |
67 |
33 |
* Cell Growth Index = (cells per flask treated group/cells per flask control group), expressed as a percentage
** Cell Growth Inhibition = 100 % - % cell growth index; not calculated for negative controls
Table 2: Cytogenetic analysis of CHO cells in the absence of metabolic activation (4 hour treatment, 16 hour recovery period)
|
Control* |
152.5 μg/ml |
305 μg/ml |
610 μg/ml |
Positive control |
||||||
Flask |
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
|
Cytotoxicity |
no |
no |
no |
no |
no |
no |
yes |
yes |
no |
no |
|
Chromatid aberrations*** |
Breaks |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
10 |
7 |
Interchanges |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
Chromosome aberrations*** |
Gaps** |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
Breaks |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Dicentric |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Rings |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
% aberrant cells |
Numerical |
2 |
3 |
5 |
5 |
4 |
5 |
3 |
3 |
1 |
2 |
Structural |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
28 |
24 |
|
Mitotic index |
|
11.0 |
11.4 |
10.8 |
10.4 |
10.0 |
10.4 |
9.6 |
8.8 |
7.4 |
6.8 |
* Solvent control with DMSO
** Total gaps
*** Total number of aberrations
Mitotic Index = number of mitotic figures x 100/500 cells counted
% Aberrant Cells: numerical cells include polyploid and endoreduplicated cells; structural cells exclude cells with only gaps
Table 3: Cytogenetic analysis of CHO cells in the presence of metabolic activation (4 hour treatment, 16 hour recovery period)
|
Control* |
152.5 μg/ml |
305 μg/ml |
1220 μg/ml |
Positive control |
||||||
Flask |
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
|
Cytotoxicity |
no |
no |
no |
no |
no |
no |
yes |
yes |
yes |
yes |
|
Chromatid aberrations*** |
Breaks |
0 |
0 |
0 |
1 |
0 |
2 |
1 |
8 |
2 |
7 |
Interchanges |
0 |
0 |
1 |
1 |
3 |
1 |
7 |
4 |
8 |
6 |
|
Chromosome aberrations*** |
Gaps** |
1 |
0 |
1 |
0 |
2 |
0 |
2 |
3 |
0 |
1 |
Breaks |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Dicentric |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
|
Rings |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
|
% aberrant cells |
Numerical |
5 |
4 |
5 |
5 |
5 |
4 |
3 |
4 |
5 |
4 |
Structural |
0 |
1 |
1 |
2 |
3 |
3 |
8 |
9 |
16 |
18 |
|
Mitotic index |
|
11.6 |
11.6 |
11.2 |
11.4 |
10.6 |
11.2 |
5.4 |
6.4 |
4.0 |
3.8 |
* Solvent control with DMSO
** Total gaps
*** Total number of aberrations
Mitotic Index = number of mitotic figures x 100/500 cells counted
% Aberrant Cells: numerical cells include polyploid and endoreduplicated cells; structural cells exclude cells with only gaps
Table 4: Cytogenetic analysis of CHO cells in the absence of metabolic activation (20 hour continuous treatment)
|
Control* |
152.5 μg/ml |
305 μg/ml |
610 μg/ml |
Positive control |
||||||
Flask |
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
|
Cytotoxicity |
no |
no |
no |
no |
no |
no |
yes |
yes |
no |
no |
|
Chromatid aberrations*** |
Breaks |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
4 |
3 |
Interchanges |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
|
Chromosome aberrations*** |
Gaps** |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
Breaks |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Dicentric |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Rings |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
% aberrant cells
|
Numerical |
3 |
4 |
4 |
4 |
4 |
3 |
4 |
4 |
4 |
3 |
Structural |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
24 |
20 |
|
Mitotic index |
|
10.4 |
10.0 |
10.2 |
10.4 |
9.4 |
10.0 |
5.2 |
4.8 |
6.6 |
6.0 |
* Solvent control with DMSO
** Total gaps
*** Total number of aberrations
Mitotic Index = number of mitotic figures x 100/500 cells counted
% Aberrant Cells: numerical cells include polyploid and endoreduplicated cells; structural cells exclude cells with only gaps
Applicant's summary and conclusion
- Conclusions:
- In a reliable study, conducted in accordance with OECD 473, in compliance with GLP, trimethoxysilane was concluded to be positive for the induction of structural and negative for the induction of numerical chromosome aberrations in CHO cells in the S9-activated test system at the highest dose tested.
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