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Diss Factsheets
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EC number: 222-217-1 | CAS number: 3388-04-3
- 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
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Genetic toxicity: in vitro
Administrative data
- 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
- Study period:
- 1978-06-05 to 1978-06-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate national standard method, with acceptable restrictions. The restrictions were, insufficient concentration levels and no duplicates were used
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- publication
- Title:
- Evaluation of the Developmental Toxicity of beta-(3,4-Epoxycyclohexyl)ethyltrimethoxysilane in Fischer 344 Rats and New Zealand White Rabbits
- Author:
- Tyl W et al
- Year:
- 1 988
- Bibliographic source:
- Fund. Appl.Tox. 10: 439-452
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- other: DMT-106
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane
- EC Number:
- 222-217-1
- EC Name:
- 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane
- Cas Number:
- 3388-04-3
- Molecular formula:
- C11H22O4Si
- IUPAC Name:
- trimethoxy[2-(7-oxabicyclo[4.1.0]hept-3-yl)ethyl]silane
Constituent 1
Method
- Target gene:
- TK
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 rat liver with Aroclor
- Test concentrations with justification for top dose:
- 0.02-2.00 µl/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Non toxic to mouse lymphoma cells.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Dimethylnitrosamine
- Remarks:
- with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium and soft agar with BrdU
DURATION
- Preincubation period: 4 hours
- Expression time (cells in growth medium): 3 days
SELECTION AGENT (mutation assays): bromodeoxyuridine (BrdU)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth
- Selection time (if incubation with a selection agent): 10days - Evaluation criteria:
- The test substance is considered positive if a dose-response is observed over 3 of the 4 dose levels employed and the minimum increase at the high level of dose-response curve is at least 2.5 times greater than the solvent and/or negative control values.
The solvent and negative control data should be within the normal range of the spontanious background for the TK locus.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxic at 1.25 µl/ml without activation and 0.020 µl/ml with activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2: Results of Mammalian Mutagenicity Assay with tester strain L5178Y
Concentration µl/ml |
Mutant Frequency * |
Relative cloning efficiency (% of Control) |
Cytotoxicity (yes/no) |
||
- MA |
+ MA |
- MA |
+ MA |
||
Solvent Control** |
20 |
19 |
100 |
100 |
No |
Negative Control |
6.1 |
12.9 |
150.7 |
107.6 |
No |
0.020 |
- |
24.5 |
- |
111 |
No |
0.040 |
- |
39.7 |
- |
81.2 |
No |
0.080 |
- |
59.4 |
- |
99.5 |
No |
0.160 |
- |
39.4 |
- |
113.8 |
No |
0.640 |
25.1 |
- |
115.9 |
- |
No |
1.250 |
46.9 |
- |
134.4 |
- |
No |
1.500 |
41.3 |
- |
134.4 |
- |
No |
1.700 |
64.7 |
- |
88.5 |
- |
No |
2.000 |
145.3 |
- |
74.9 |
- |
No |
Positive Control |
358 |
1850 |
88.1 |
2.7 |
No |
* Mutantfrequency per 106 surviving cells.
** Solvent: DMSO
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation
The test material produced a dose related increase in cytotoxicity / mutant frequency, both with and without metabolic activation. The test material was mutagenic in the mouse lymphoma forward mutation assay. The mutagenic response was greater under non activated conditions.
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