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EC number: 610-847-3 | CAS number: 524709-77-1
- 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
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 11, 2009 - June 19, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[3,5-difluoro-4-(trifluoromethoxy)phenyl]-3-fluoro-4'-[(1s,4r)-4-propylcyclohexyl]-1,1'-biphenyl
- EC Number:
- 610-847-3
- Cas Number:
- 524709-77-1
- Molecular formula:
- C28H26OF6
- IUPAC Name:
- 4-[3,5-difluoro-4-(trifluoromethoxy)phenyl]-3-fluoro-4'-[(1s,4r)-4-propylcyclohexyl]-1,1'-biphenyl
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
- Remarks:
- The test item concentration was not quantified at the start and the end of this study. Because of the low calculated water solubility (0.0002214 µg/L), the compound cannot be detected with standard analytical methods.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Before exposure of the fish, the test medium (reconstituted water and test material) was freshly prepared. The calibrated flask with test material and vehicle (reconstituted water) was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was aerated and stirred with a magnetic stirrer for further 23 hours. After 24 hours the formulation was given through a nutsch filter (pore size 10 - 16 µm). The filtrate was used for the study.
- Controls: reconstituted water
- Chemical name of vehicle: OECD 203 Medium
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish (Danio rerio)
- Strain: West-Aquarium
- Source: Institute of Toxicology, Merck KGaA
- Age at study initiation (mean and range, SD):
- Length at study initiation: 2.0 ± 1.0 cm
- Weight at study initiation: Body weight per group: 7.1 g (control group) and 7.3 g (test material group)
ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation:
- Feeding frequency during acclimation: During the acclimatization, until one day before the experimental part, the fish were fed with flakes (Tetra Min® diet; Tetra GmbH, Melle). Furthermore, the fish were fed with daphnia, or artemia, or frozen mosquitolarva daily.
- Health during acclimation (any mortality observed): no mortality observed
FEEDING DURING TEST
The zebrafish were not fed during the study.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no
Test conditions
- Hardness:
- about 267 mg/L CaCO3
- Test temperature:
- 23 to 24°C
- pH:
- 7.07 - 7.95
- Dissolved oxygen:
- 61.3 - 92.3%
- Salinity:
- no data
- Conductivity:
- no data
- Nominal and measured concentrations:
- Nominal Concentration: 100 mg/L
- Details on test conditions:
TEST SYSTEM
- Test vessel: 10L glass aquarium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 10L, no headspace, about 10L
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (OECD 203 Medium)
- Ca/Mg ratio: 4 : 1
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours light - 12 hours dark regime
- Light intensity: no data
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and Clinical Symptoms (daily)
TEST CONCENTRATIONS
- Range finding study:
- Test concentrations: 0 mg/L and 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: no mortality observed- Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 0.0002214 µg/L
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 0.0002214 µg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 0.0002214 µg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 0.0002214 µg/L
- Details on results:
- A saturated aqueous solution of Art. 281322 of nominal 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebrafish exceeded the maximal solubility of 0.0002214 µg/L of the test material in reconstituted water and, thus, could not be determined in this test.
The 96h EC50 exceeded the water solubility of 0.0002214 µg/L (nominal >100 mg/L) and, thus, could not be determined in this study.
- Behavioural abnormalities: no
- Observations on body length and weight: none
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: yes
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- An aqueous solution of the test item with a nominal concentration of 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value for zebrafish exceeded the maximal solubility of the test material in reconstituted water and, thus, could not be determined in this test.
- Executive summary:
This study was performed according to OECD 203 under GLP conditions. An aqueous solution of the test item with a nominal concentration of 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50value for zebrafish exceeded the maximal solubility of the test material in reconstituted water and, thus, could not be determined in this test.
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