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EC number: 459-330-2 | CAS number: -
- 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:
- 05/Oct/98 - 27/Jan/99
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether
- EC Number:
- 609-858-6
- Cas Number:
- 406-78-0
- Molecular formula:
- C4H3F7O
- IUPAC Name:
- 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name: 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether [HFE 347 pc-f]
BML test substance number: BML-4262
Lot number: T52068101
Purity: 99.8wt%
Impurity name and concentration: No information
Appearance at room temperature: Liquid
Stability: Stable at 120°C under the presence of iron or SUS for 3 days
Solubility: Water (0.011g/100g H20), DMSO (>1000mg/mL), Acetone (Readily soluble)
Stability in solvent: Water (stable, no change), DMSO (stable, no change, dissolution in 1:1 mixture), Acetone (stable, no change, dissolution in 1:1 mixture)
Storage condition: Room temperature
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Composition of S9 mix (in 10mL): S9 (3mL), Cofactor (7mL), HEPES buffer (40umol), MaCl2 (50umol), KCl (330umol), G-6-P (50umol), NADP (40umol)
- Test concentrations with justification for top dose:
- The dose range in the chromosome aberration test was selected in accordance with the results of the cell growth inhibition test. From the results of the cell growth inhibition test, cell growth inhibition in both short-term and continuous exposure experiments were not observed at 5.0mg/L (the maximum concentration). Based on this result, the maximum concentration of test substance in 24 and 48 hour exposure experiments was selected at 5.0mg/mL, with 3 lower concentrations diluted from the maximum concentration by a common ratio of 2.
- Vehicle / solvent:
- The solvent selected was Dimethyl sulfoxide (DMSO) since the test substance had a low solubility in water at (0.011g/100g)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- other: Physiological saline
- Details on test system and experimental conditions:
- Cultured Mammalian cells: The cell line of the Chinese hamster fibroblasts in lung (CHL/IU cells, modal chromosome number of 25) was used.
Cell culture medium: Eagle's MEM supplemented with 10% calf serum was used.
Growth form: The cell cultures were incubated using a CO2 gas incubator under the conditions of a highly humidified atmosphere with 5% CO2 at 37°C.
Cell stock conditions: Cells were stored in the deep temperature freezer (-80°C) or tank with liquid nitrogen (-196°C). 10v/v% of dimethyl sulfoxide was added to the culture medium at the time of storage.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Additional information on results:
- In the results of the chromosome aberration test in the short-term exposure experiment both with and without the S9 mix, the frequency of cells carrying structural chromosome aberrations or polyploidy were not increased at any concentration compared with negative (untreated and solvent) controls. In the positive (MMC) control group, in the short-term exposure experiment without S9 mix, the frequency of cells carrying structural chromosome aberrations was 16%. In the positive (DMN) control group, in the short-term exposure experiment with S9 mix, the frequency of cells carrying structural chromosomal aberrations was 70%.
In the results of the chromosome aberration test in both 24- and 48-hour exposure, the frequency of cells carrying structural chromosome aberrations or polyploidy were not increased at any concentration compared with negative controls. In the positive (MMC) control groups in continuous exposure experiments, the frequencies of cells carrying structural chromosome aberrations in 24 and 48 hour exposure were 39.5 and 46.5% respectively.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions described, it was concluded that 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether did not induce chromosome aberrations in the cell line of Chinese hamster fibroblast in the lung (CHL/IU cells).
- Executive summary:
An in vitro chromosome aberration test in cultured mammalian cells (CHL/IU cells) was performed to assess the potential of 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether to induce chromosome aberrations.
Since cell growth inhibition in both short-term and continuous exposure experiments were not observed at 5.0mg/mL (max concentration) in the results of the cell growth inhibition test, the concentrations of 50% cell growth inhibition for this test substance were more than 5.0mg/mL. Therefore, the maximum concentration of test substance in short term and continuous exposure experiments was 5.0mg/mL, and 3 applied concentrations which were prepared with dilution by a common ratio of 2 were set up and examined.In the results of the chromosome aberration test in short-term and continuous exposure experiments, the frequency of cells carrying structural chromosome aberrations or polyploidy were not increased at any concentration compared with negative (untreated and solvent) controls.
Based on the above results, it was concluded that 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether did not induce chromosomal aberrations in CHL/IU cells.
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