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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 aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 11, 2009 - March 30, 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 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- 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
- Specific details on test material used for the study:
- Preparation of the Test Item:
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. The formulation was then passed through a single use syringe filter (pore size 0.2 µm). The filtrate was used for the study.
Sampling and analysis
- Analytical monitoring:
- no
- Remarks:
- The test material concentration was not quantified at the start and the end of this study due to the very low water solubility. Because of the low water (calculated 0.0000002214 mg/L), the compound cannot be detected with standard analytical methods.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- Macro nutrients (mg/L)
CaCI2 •2H20 293.80
MgSO4•7H20 123.30
NaHCO3 64.80
KCI 5.80
Na2SiO3•9H20 10.00
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18
Trace elements (mg/L)
B 0.5000
Fe 0.2000
Mn 0.1000
Li, Rb and Sr 0.0500
Mo 0.0250
Br 0.0125
Cu and Zn 0.0063
Co and I 0.0025
Se 0.0010
V 0.0003
Macro nutrients (mg/L)
Na2EDTA • 2H20 2.50
Vitamins (µg/L):
Thiamine 75.00
B12 1.00
Biotin 0.75
- pH: 7.77
Preparation of the Test Item:
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. The formulation was then passed through a single use syringe filter (pore size 0.2 µm). The filtrate was used for the study.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species: Daphnia magna Straus
Culture conditions: The clone is bred in the laboratories of Merck KGaA.
Parental daphnids are used for reproduction until they are about 6 weeks old. Thereafter, they are replaced by neonates.
Daphnids are kept individually in 100 mL glass vessels containing approximately 60 mL reconstituted water (ELENDT M4 medium) at a water temperature of 20 ± 2°C and a 16 hour light and 8 hour dark regime to ensure similar conditions as in the experiment. Offspring are removed from the vessels at least twice per week.
Feeding: The parental daphnids are fed ad libitum with unicellular green algae Desmodesmus subspicatus three times per week.
Age: Offspring less than 24 hours old were used for the study.
Acclimation period: same as test
Feeding during test: None
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 21°C
- pH:
- 7.70 - 7.84
- Dissolved oxygen:
- 89.8 - 95.1%
- Nominal and measured concentrations:
- Nominal 100 mg/L
- Details on test conditions:
- EXPOSURE:
The study was performed in an air-conditioned room. At the start of the experimental phase, 5 daphnids were placed into test vessels with 10 mL of reconstituted water (4 vessels / control group) or test medium (4 vessels / test material group). The daphnids were not fed, and the control medium and test medium were not aerated during the test.
The test was performed as a static test in open vessels.
The duration of exposure was 48 hours. During the exposure period, the mobility of the daphnids was assessed daily, i.e. after 24 and 48 hours.
NO. OF DAPHNIDS:
Control Group: 20 daphnids
100 mg/L: 20 daphnids
CONCENTRATION(S)
In a pre-test no immobilization was observed at a concentration of 100 mg/L under open static conditions. Therefore, the solution of a nominal test item concentration of 100 mg/L was tested in the present study.
For the control, reconstituted water (ELENDT M4 medium) was used.
VEHICLE
Reconstituted water (ELENDT M4 medium) was used as vehicle.
Macro nutrients (mg/L)
CaCI2 •2H20 293.80
MgSO4•7H20 123.30
NaHCO3 64.80
KCI 5.80
Na2SiO3•9H20 10.00
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18
Trace elements (mg/L)
B 0.5000
Fe 0.2000
Mn 0.1000
Li, Rb and Sr 0.0500
Mo 0.0250
Br 0.0125
Cu and Zn 0.0063
Co and I 0.0025
Se 0.0010
V 0.0003
Macro nutrients (mg/L)
Na2EDTA • 2H20 2.50
Vitamins (µg/L):
Thiamine 75.00
B12 1.00
Biotin 0.75
- pH: 7.77
- O2-Concentration: 94.3%
- Culture medium different from test medium: no
- Intervals of water quality measurement: 48 h
OTHER TEST CONDITIONS
- Photoperiod: 16h light / 8h dark
References:
ELENDT, B.-P. Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus.
Protoplasma 154, 25-33, 1990 - Reference substance (positive control):
- no
- Remarks:
- No positive control used in this study. The accuracy and reliability of the test method is demonstrated periodically as recommended by guidelines with potassium dichromate.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: EC50 >0.0000002214 mg/L
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: EC50 >0.0000002214 mg/L
- Details on results:
- An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system.
The 48h EC50 exceeded the water solubility of 0.0000002214 mg/L (nominal >100 mg/L) and, thus, could not be determined in this study.
- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
Any other information on results incl. tables
Objective
The objective of this study was to evaluate the influence of the test material on the immobilization of Daphnia magna.
Study Design
For this purpose, juvenile Daphnia magna were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration and control group containing five Daphnia magna each, i.e. 20 Daphnia magna per concentration (test medium group) and per control group. Daphnia magna were exposed to a nominal test material concentration of 100 mg/L (Limit test) in an open static system.
Results
The test material concentration in the aqueous medium was not quantified at the start and the end of this study due to the very low water solubility, which was calculated (0.0000002214 mg/L). Because of the low water solubility, the compound cannot be detected with standard analytical methods. The development of an analytical method with a sufficiently low detection and quantification limit is complex. Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification.
No effect on the mobility of the daphnia was observed at a nominal concentration of 100 mg/L.
For the test item the following EC50 values were determined:
EC50 (24h) >0.0000002214 mg/L (nominal >100 mg/L)
EC50 (48h) >0.0000002214 mg/L (nominal >100 mg/L)
Conclusion
An aqueous
solution of nominal 100 mg/L of the test item revealed
no aquatic toxicity in the test system. The 48 hour EC50for Daphnia
magna exceeded the maximum solubility of the test material in
reconstituted water (0.0000002214 mg/L) and, thus, could not be
determined in this test.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50 for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (0.0000002214 mg/L) and, thus, could not be determined in this test.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 202. An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (0.0000002214 mg/L) and, thus, could not be determined in this test.
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