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EC number: 250-807-9 | CAS number: 31795-24-1
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2003-10-16 to 2003-11-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. The original study was reliability 1. Read-cross to the registered substance is considered scientifically justified and reliability 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- Trimethoxy(methyl)silane
- EC Number:
- 214-685-0
- EC Name:
- Trimethoxy(methyl)silane
- Cas Number:
- 1185-55-3
- IUPAC Name:
- trimethoxy(methyl)silane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster ovary (CHO-K1) cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9, NADP as cofactor
- Test concentrations with justification for top dose:
- 170.3, 340.6, 681.2 and 1362.4 µg/ml. The cells treated with 170.3 µg/ml were not evaluated for chromosome aberrations.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: based information provided by sponsor and compatibility with the 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:
- ACTIVATION: 1 ml S9 mix containing 20 µl Aroclor induced rat liver S9, NADP as cofactor, added to 4 ml of medium
METHOD OF APPLICATION: in medium;
DURATION
- Preincubation period: none
- Exposure duration: 4 or 20 hours (without activation), 4 hours with activation
- Expression time (cells in growth medium): 0 or 16 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 20 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid added 2 h prior to harvest
STAIN (for cytogenetic assays): Giesma
NUMBER OF REPLICATIONS: duplicate cultures per concentration
NUMBER OF CELLS EVALUATED: mitotic index in 500 cells, aberrations in 200 cells (100 per duplicate flask)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; other: cell count and percentage viability
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication:yes - Evaluation criteria:
- A test substance is considered positive if 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; in the event of a positive result, Cochran Armitage test used to measure dose-responsiveness
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- with activation
- Cytotoxicity / choice of top concentrations:
- other: > 1362.4 μg/ml
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: cell growth inhibition was between 7% and 17% in the highest dose tested.
COMPARISON WITH HISTORICAL CONTROL DATA: control values were within historical data.
ADDITIONAL INFORMATION ON CYTOTOXICITY: - Remarks on result:
- other: other: Chinese hamster ovary (CHO-K1) cells
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The percentage of cells with structural or numerical aberrations in the non-activated 4 and 20 hour exposure groups was not significantly increased above that of the solvent control at any dose level. The percentage of cells with structural aberrations in the S9 activated 4 hour exposure group was significantly increased above that of the solvent control at 1362.4 ug/mL. The Cochran-Armitage test was also positive for a dose response. The percentage of cells with numerical aberrations in the test article-treated group was not significantly increased above that of the solvent control at any dose level. The results of the assay are summarized in the following table:
WITHOUT S9:
Treatment time: 4 hr
Recovery time: 16 hr
Harvest time: 20 hr
Toxicity* at highest dose scored: 16%
Mitotic Index Reduction**: None
LED for Structural Aberrations (µg/mL): None
LED for Numerical Aberrations (µg/mL): None
WITHOUT S9:
Treatment time: 20 hr
Recovery time: 0 hr
Harvest time: 20 hr
Toxicity* at highest dose scored: 4%
Mitotic Index Reduction**: 9%
LED for Structural Aberrations (µg/mL): None
LED for Numerical Aberrations (µg/mL): None
WITH S9:
Treatment time: 4 hr
Recovery time: 16 hr
Harvest time: 20 hr
Toxicity* at highest dose scored: 22%
Mitotic Index Reduction**: 16%
LED for Structural Aberrations (µg/mL): 1362.4
LED for Numerical Aberrations (µg/mL): None
Where:
* Cell growth inhibition
** Relative to solvent control at high dose evaluated for
chromosome aberrations
LED = Lowest Effective Dose
Table 1: 4 h treatment without activation (totals and percentages from 200 cells)
Treatment |
Solvent Control |
Positive control* |
340.6 µg/ml |
681.2 µg/ml |
1362.4 µg/ml |
|
Cytotoxicity |
no |
no |
no |
no |
no |
|
Chromatid aberrations |
gaps |
1 |
3 |
0 |
2 |
2 |
breaks |
1 |
14 |
1 |
0 |
0 |
|
interchanges |
0 |
13 |
1 |
1 |
. |
|
Chromosome aberrations |
breaks |
0 |
0 |
0 |
0 |
0 |
dicentric |
0 |
0 |
1 |
2 |
3 |
|
ring |
0 |
0 |
0 |
0 |
0 |
|
Percent aberrant cells |
Numerical |
2.5 |
1.5 |
2 |
3 |
3 |
Structural |
0.5 |
29.0 |
1.5 |
1.5 |
2 |
|
Mitotic index |
7.3 |
8.1 |
8.4 |
7.5 |
7.6 |
* 100 cells evaluated
Table 2: 4 h treatment with activation (totals and percentages from 200 cells)
Treatment |
Solvent Control |
Positive control* |
340.6 µg/ml |
681.2 µg/ml |
1362.4 µg/ml |
|
Cytotoxicity |
no |
yes |
no |
no |
no |
|
Chromatid aberrations |
gaps |
1 |
4 |
0 |
0 |
2 |
breaks |
1 |
30 |
0 |
0 |
7 |
|
interchanges |
0 |
19 |
0 |
0 |
13 |
|
Chromosome aberrations |
breaks |
0 |
0 |
0 |
0 |
0 |
dicentric |
0 |
3 |
2 |
2 |
2 |
|
ring |
0 |
0 |
0 |
0 |
0 |
|
Percent aberrant cells |
Numerical |
2 |
1.5 |
1.5 |
3.5 |
4.0 |
Structural |
0.5 |
22.5 |
1.0 |
3.0 |
9.5 |
|
Mitotic index |
9.3 |
8.6 |
8.4 |
8.2 |
7.8 |
* 100 cells evaluated
Table 3: 20 h treatment without activation (totals and percentages from 200 cells)
Treatment |
Solvent Control |
Positive control* |
340.6 µg/ml |
681.2 µg/ml |
1362.4 µg/ml |
|
Cytotoxicity |
no |
no |
no |
no |
no |
|
Chromatid aberrations |
gaps |
1 |
6 |
0 |
1 |
1 |
breaks |
1 |
28 |
0 |
0 |
0 |
|
interchanges |
0 |
18 |
0 |
1 |
0 |
|
Chromosome aberrations |
breaks |
0 |
0 |
0 |
0 |
0 |
dicentric |
0 |
2 |
3 |
4 |
4 |
|
ring |
0 |
1 |
0 |
0 |
0 |
|
Percent aberrant cells |
Numerical |
2 |
1.5 |
2 |
1.5 |
1.5 |
Structural |
0.5 |
20 |
1.5 |
2.5 |
2.0 |
|
Mitotic index |
7.9 |
7.4 |
6.8 |
7.0 |
6.3 |
* 100 cells evaluated
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
negative without metabolic activation
Trimethoxy(methyl)silane has been tested in a valid study conducted according to OECD 473 and in compliance with GLP. The test substance induced a statistically significant dose related increase in the number of structural aberrations in Chinese hamster ovary (CHO-K1) cells in the presence of activation. No test-substance related genotoxicity was observed in the absence of metabolic activation. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is positive for the induction of chromosome aberrations in the presence of activation under the conditions of the study.
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