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EC number: 841-499-2 | CAS number: 1340593-59-0
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- number of animals used, exposure period, use of a valid controls were not reported
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 2-(2,4-difluorophenyl)-1,1-difluoro-3-(1H-1,2,3,4-tetrazol-1-yl)-1-{5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl}propan-2-ol
- EC Number:
- 841-499-2
- Cas Number:
- 1340593-59-0
- Molecular formula:
- C23H16F7N5O2
- IUPAC Name:
- 2-(2,4-difluorophenyl)-1,1-difluoro-3-(1H-1,2,3,4-tetrazol-1-yl)-1-{5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl}propan-2-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Duration of treatment / exposure:
- not specified
- Frequency of treatment:
- not specified
- Post exposure period:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/kg bw/day
- Dose / conc.:
- 400 mg/kg bw/day
- Dose / conc.:
- 800 mg/kg bw/day
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Positive control(s):
- not specified
Examinations
- Tissues and cell types examined:
- Micronucleated polychromatic erythrocytes in the bone marrow of male rats.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The micronucleus test was conducted in two phases: a dose-range-finding phase in which the toxicity of the test item was evaluated and a definitive phase that evaluated the ability of the test item to increase the incidence of micronucleated polychromatic erythrocytes in the bone marrow of male rats.
Based on the findings of clinical observations and mortality at doses of ≥1000 mg/kg obtained in the dose-range-finding study, a dose of 800 mg/kg was determined to be the maximum tolerated dose and was set as high dose for the definitive micronucleus study. As no differences between the sexes in the clinical signs of toxicity were observed, the main study was conducted using male rats only. - Evaluation criteria:
- The ability of the test item to increase the incidence of micronucleated polychromatic erythrocytes in the bone marrow of male rats was evaluated.
- Statistics:
- not specified
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions reported (2R)-2-(2,4-difluorophenyl)-1,1-difluoro-3-(tetrazol-1-yl)-1-[5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl]propan-2-ol was determined to be negative for mutagenicity in an in vivo rat bone marrow micronucleus assay.
- Executive summary:
In a GLP rats bone marrow micronucleus assay, were treated orally with(2R)-2-(2,4-difluorophenyl)-1,1-difluoro-3-(tetrazol-1-yl)-1-[5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl]propan-2-ol.The micronucleus test was conducted in two phases: a dose-range-finding phase in which the toxicity of the test item was evaluated and a definitive phase that evaluated the ability of the test item to increase the incidence of micronucleated polychromatic erythrocytes in the bone marrow of male rats. Based on the findings of clinical observations and mortality at doses of ≥1000 mg/kg obtained in the dose-range-finding study, a dose of 800 mg/kg was determined to be the maximum tolerated dose and was set as high dose for the definitive micronucleus study. As no differences between the sexes in the clinical signs of toxicity were observed, the main study was conducted using male rats only.
In the definitive phase rats were treated with the test item atdoses of 200, 400, or 800 mg/kg. There was not a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow in all tested dose.
Therefore, the test item was concluded to be negative in the rat micronucleus assay
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