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EC number: 425-050-4 | CAS number: 10217-34-2
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate test protocol and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The used protocol is in compliance with: OECD 471, 1983 EC Directive 92/69, B.13 and B.14
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 425-050-4
- EC Name:
- -
- Cas Number:
- 10217-34-2
- Molecular formula:
- C14H28O4Si
- IUPAC Name:
- triethoxy(2-{7-oxabicyclo[4.1.0]heptan-3-yl}ethyl)silane
- Details on test material:
- Test article ID (as cited in the study): Y-4036 is beta-(3,4-epoxycyclohexyl)ethyltriethoxysilane
Molecular formula: C13H26O4Si
Molecular weight: 274,43
Physical state: Clear, pale liquid
Analytical purity: 98.3%
Lot/batch no: 16912-29
Test article receipt: 1995-09-18 (expiration date was not provided)
Stability under test conditions: Stable
Storage condition of test material: At room temperature; protected from exposure to light
Certificate of analysis: see appendix IV (GC, FTIR, GC/MS)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537 E-Coli: WP2 uvrA(pKM101), WP2 (pKM101)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9-homogenate
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3.3 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 3.3 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- all Salmonella strains
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9 Activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- WP2 uvrA (pKM101) strain
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9 Activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- WP2 (pKM101) strain
- Positive control substance:
- other: sterigmatocystin
- Remarks:
- with S9 Activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA98 strain
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9 Activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA100, TA1535
- Positive control substance:
- sodium azide
- Remarks:
- without S9 Activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 Activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- both E. coli strains
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9 Activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 60 minutes at 37°C (methodology by Yahagi et al. (1977))
- Exposure duration: 48 to 72 hours at 37°C
- Expression time (cells in growth medium): 48 to 72 hours at 37°C
NUMBER OF REPLICATIONS: 3 plates per test concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; background lawn assessment - Evaluation criteria:
- For the test article to be evaluated positive, it must cause 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. Data sets for strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value. Data sets for strains TA98, TA100 and WP2 uvrA (pKM101) and WP2 (pKM101) were judged positive if the increase in mean revertants at the peak of the dose response is equal or greater than two times the mean vehicle control value.
- Statistics:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 667 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 333 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 333 µg/plate)
- Additional information on results:
- Comparison with historical control data: Number of spontaneous revertants were within acceptable range.
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment B5 (without S9) | TA98 | TA100 | TA1535 | TA1537 | ||||
Conc. µg/plate | average revertants per plate | standard deviation | average revertants per plate | standard deviation | average revertants per plate | standard deviation | average revertants per plate | standard deviation |
0 | 26 | 3 | 115 | 5 | 6 | 3 | 6 | 2 |
3.3 | 4 | 3 | ||||||
10 | 26 | 2 | 124 | 15 | 8 | 1 | 5 | 3 |
33 | 17 | 2 | 126 | 12 | 12 | 2 | 7 | 4 |
100 | 20 | 2 | 118 | 10 | 9 | 0 | 6 | 2 |
333 | 21 | 5 | 18 | 11 | 7 | 3 | 1 | 2 |
1000 | 17 | 3 | 14 | 3 | 6 | 3 | 0 | 0 |
5000 | 20 | 5 | 14 | 4 | 5 | 2 | ||
Pos | 504 | 36 | 515 | 27 | 394 | 25 | 201 | 107 |
(with S9) | TA98 | TA100 | TA1535 | TA1537 | WP2 (pKM101) | |||||
Conc. µg/plate | average revertants per plate | standard deviation | average revertants per plate | standard deviation | average revertants per plate | standard deviation | average revertants per plate | standard deviation | average revertants per plate | standard deviation |
0 | 25 | 2 | 142 | 18 | 10 | 5 | 7 | 2 | 61 | 11 |
3.3 | 7 | 1 | ||||||||
10 | 20 | 5 | 117 | 4 | 14 | 1 | 8 | 3 | 45 | 4 |
33 | 22 | 3 | 151 | 4 | 12 | 2 | 11 | 1 | 63 | 8 |
100 | 24 | 4 | 136 | 5 | 12 | 2 | 5 | 2 | 67 | 3 |
333 | 22 | 2 | 66 | 13 | 12 | 4 | 3 | 3 | 58 | 13 |
1000 | 8 | 5 | 21 | 10 | 6 | 1 | 1 | 1 | 49 | 10 |
5000 | 8 | 2 | 3 | 2 | 7 | 4 | 67 | 5 | ||
Pos | 1101 | 38 | 1132 | 165 | 88 | 7 | 111 | 12 | 312 | 1 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
2-(3,4-epoxycyclohexyl)ethyltriethoxy silane has been tested in a reliable study according to OECD TG 471 and under GLP. The test substance did not show any reproducible mutagenic activity in any of the tester strains with or without metabolic activation (Aroclor-induced rat liver S9). It is concluded that the test subtance is negative for mutagenicity to bacteria under the conditions of the test.
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