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EC number: 201-061-8 | CAS number: 77-83-8
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Galloway SM, Bloom AD, Resnick M, Margolin BH, Nakamura F, Archer P, Zeiger E (1985): Development of a standard protocol for in vitro cytogenetic testing with Chinese hamster ovary cells. Environ Mutagen 7: 1-51.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- EC Number:
- 201-061-8
- EC Name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- Cas Number:
- 77-83-8
- Molecular formula:
- C₁₂H₁₄O₃
- IUPAC Name:
- ethyl 3-methyl-3-phenyloxirane-2-carboxylate
- Details on test material:
- - Names of test material (as cited in study report): 3-methyl-3-phenylglycidic acid, ethyl ester, CAS No. 77-83-8
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: Source: National Toxicology Program chemical repository (Radian Corp., Austin, TX)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Cell line: CHO-W-B1
- Type and identity of media: McCoy's 5a medium with 5 % foetal calf serum, L-glutamine and antibiotics.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix consisting of 15 µL/mL liver homogenate (from male Sprague-Dawley rats, induced with Aroclor 1254), 2.4 mg/mL NADP, and 4.5 mg/mL isocitric acid in serum-free medium.
- Test concentrations with justification for top dose:
- 50 µg/mL, 160 µg/mL, 500 µg/mL (half-log increments).
- Vehicle / solvent:
- - Solvents used: either water, dimethyl sulfoxide (DMSO), ethanol or acetone, in that order of preference. It is unclear which solvent was used for the test material.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Solvents used: either water, dimethyl sulfoxide (DMSO), ethanol or acetone, in that order of preference. It is unclear which solvent was used for the test material.
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: Concentration - 0.15 µg/mL. Without metabolic activation only.
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: Concentration - 15 µg/mL. With metabolic activation only.
- Details on test system and experimental conditions:
METHOD OF APPLICATION: In medium.
DOSE SELECTION
- Doses were chosen for the aberration test based on a preliminary test of cell survival 24 hrs after treatment. For most tests, doses were based on observations of cell confluence and mitotic cell availability in the SCE test (reported elsewhere).
DURATION
- Exposure duration:
-- With S9 mix: 2 hr
-- Without S mix: Throughout incubation period
- Expression time (cells in growth medium):
- Fixation time (start of exposure up to fixation or harvest of cells): 8 to 12 hr standard (cells in first mitosis). In cases where experience suggested that mitosis was delayed by the presence of the test material, harvesting was delayed to "e.g. 18-26 hr".
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 1
EVALUATIONS
- No. of cells evaluated: 100 cells from each of the 3 highest groups having sufficient metaphases for analysis, and from positive and solvent controls.
- Determination of polyploidy: Aberrations from polyploid cells not scored, but metaphases with 19-23 chromosomes were used.
- All types of aberrations were recorded separately, but for data analysis they were grouped into categories of "simple" (breaks and terminal deletions), "complex" (exchanges and rearrangements), "other" (including pulverised chromosomes), and "total".- Statistics:
- Linear regression analysis of the percentage of cells with aberrations vs the log-dose was used as the test for trend. To examine absolute increases over control levels at each dose, a binomial sampling assumption (as opposed to Poisson) was used, Margolin et al. (1983). The P values were adjusted by Dunnett's method to take into account the multiple dose comparisons. For data analysis, the "total" aberration category was used and the criterion for a positive response was that the adjusted P value be ≤ 0.05
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not determined
- 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
Metabolic activation | Result | Range (µg/mL) | Least effect concentration (µg/mL) |
Without S9 mix | + | 50 - 500 | < 50 |
With S9 mix | ? | 50 - 500 | 500 |
The least effective concentration tested (LEC) is the lowest dose to give a statistically significant increase (P ≤ 0.05) in aberrations. For chemicals with which the lowest dose tested gave a positive response, the LEC is preceded by "<".
Results without metabolic activation
Harvest time: 14 hrs
Result: Positive
Dose (µg/mL) | Cells | Percentage cells with aberrations | ||
Total | Simple | Complex | ||
Negative control | ||||
0 | 100 | 1 | 0 | 1 |
Test material | ||||
50 | 100 | 8 | 4 | 4 |
160 | 100 | 4 | 4 | 1 |
500 | 100 | 8 | 7 | 1 |
Positive control - MMC | ||||
15 | 50 | 34 | 26 | 14 |
Results with metabolic activation
Harvest time: 14 hrs.
Result: Unclear
Dose (µg/mL) | Cells | Percentage cells with aberrations | ||
Total | Simple | Complex | ||
Negative control | ||||
0 | 100 | 4 | 3 | 1 |
Test material | ||||
50 | 100 | 9 | 7 | 2 |
160 | 100 | 9 | 7 | 2 |
500 | 100 | 12 | 10 | 2 |
Positive control - CP | ||||
0.15 | 50 | 28 | 18 | 14 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
positive without metabolic activation
ambiguous with metabolic activation
Galloway et al. found that the test material was positive without metabolic activation, and ambiguous with metabolic activation in a chromosome aberration test for genotoxicity.
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