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EC number: 265-929-8 | CAS number: 65799-47-5
- 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:
- key study
- Study period:
- 2004-04-26 to 2004-2004-05-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
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)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- [3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
- EC Number:
- 220-780-8
- EC Name:
- [3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
- Cas Number:
- 2897-60-1
- Molecular formula:
- C11H24O4Si
- IUPAC Name:
- Diethoxy-methyl-[3-(oxiran-2-ylmethoxy)propyl]silane
- Reference substance name:
- [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane
- IUPAC Name:
- [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: Human blood
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone and naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 9.7, 19.41, 38.81, 77.63, 155.25*, 310.5*, 621*, 1242, 1863, 2484 µg/ml (* analysed concentrations)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- (with activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- (without activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
ACTIVATION: 1ml of 20 % S9 mix ( ie 2 % final concentration of S9 in standard co-factors) was added to the cultures.
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 20 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Gurrs Giemsa
NUMBER OF REPLICATIONS: 2 cultures per dose level
NUMBER OF CELLS EVALUATED: 950 in total. (150 for positive control, 200 for treatments and vehicle control)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index, relative total growth
OTHER EXAMINATIONS:
- Determination of polyploidy: mean frequency % for experiment 1 - Evaluation criteria:
- A positive response was recorded if the % of cells with aberrations, excluding gaps, markedly exceeded that seen in the concurrent control, with or
without a clear dose-relationship. For modest increases in aberration frequency a dose response relationship is generally required and appropriate
statistical tests may be applied in order to record a positive response
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes: human blood
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 50% mitotic inhibition at 310.5 μg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes: human blood
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 73% mitotic inhibition at 2484 μg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
Any other information on results incl. tables
Table 3: Results of chromosome analysis Experiment 1, 4h treatment without activation (total count from 2 cultures)
|
Solvent* Control** |
Positive Control*** |
621 μg/ml** |
310.5 μg/ml** |
155.25 μg/ml** |
|
Cytotoxicity |
No |
Yes |
No |
Yes |
Yes |
|
|
Mean |
|||||
Chromatid aberrations |
gaps |
2 |
20 |
33 |
14 |
8 |
breaks |
1 |
25 |
36 |
10 |
5 |
|
interchanges |
1 |
33 |
28 |
1 |
0 |
|
Chromosome aberrations |
gaps |
NR |
NR |
NR |
NR |
NR |
breaks |
0 |
2 |
4 |
3 |
1 |
|
interchanges |
0 |
1 |
0 |
0 |
0 |
|
Mitotic index (%) |
100 |
49 |
16 |
50 |
80 |
|
Polyploidy (% mean freq.) |
0.5 |
0 |
0 |
0.5 |
0 |
|
Endo reduplication |
NR |
NR |
NR |
NR |
NR |
*Solvent control with DMSO
** Per 200 cells
*** Per 150 cells
NR not reported
Table 4: Results of chromosome analysis Experiment 1, 4h treatment with activation (total count from 2 cultures)
|
Solvent* Control** |
Positive Control*** |
621 μg/ml** |
1242 μg/ml** |
1863 μg/ml** |
2484 μg/ml*** |
|
Cytotoxicity |
No |
Yes |
No |
No |
No |
Yes |
|
|
Mean |
||||||
Chromatid aberrations |
gaps |
0 |
39 |
8 |
8 |
26 |
27 |
breaks |
0 |
47 |
1 |
4 |
25 |
42 |
|
interchanges |
0 |
33 |
0 |
3 |
7 |
14 |
|
Chromosome aberrations |
gaps |
NR |
NR |
NR |
NR |
NR |
NR |
breaks |
1 |
3 |
1 |
3 |
5 |
5 |
|
interchanges |
0 |
0 |
0 |
0 |
0 |
1 |
|
Mitotic index (%) |
100 |
19 |
117 |
70 |
57 |
27 |
|
Polyploidy (% mean freq.) |
0 |
0 |
0 |
0 |
1.5 |
0 |
|
Endo reduplication |
NR |
NR |
NR |
NR |
NR |
NR |
*Solvent control with DMSO
** Per 200 cells
*** Per 100 cells
NR not reported
Applicant's summary and conclusion
- Conclusions:
- I[3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane has been tested in a study carried out according OECD 473 and in compliance with GLP. The test material induced a statistically significant dose-related increase in the frequency of cells with chromosome aberrations in both the absence and presence of metabolic activation. Appropriate solvent and positive controls were included and gave expected results. The test material was therefore considered to be clastogenic to human lymphocytes in vitro under the conditions of the study.
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