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EC number: 608-462-0 | CAS number: 303186-20-1
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
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:
- April 18, 2013 - February 14, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 18, 2013 - February 14, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100 mg/L
- Sampling method: The saturated solution of the test item and the control were analysed by HPLC-DAD at the start of the exposure intervals (0h) on days 0, 9, 14, 16 and at the end of the exposure intervals (48 or 72h) on days 2, 12, 16 and 19. For the analyses at the end of the exposure intervals, seperate replicates without algae and daphnids were prepared and stored under test condictions until sampling.
- Sample storage conditions before analysis: All original samples were stored at 6 +- 2°C until sample preparation. - Vehicle:
- yes
- Remarks:
- Elendt M4, according too ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A saturated solution (100 mg/L) was prepared with dilution water one day before start of each exposure interval. The test item (100 mg/L) was transferred with an appropriate amount of the dilution water into brown glass flask and shaken overhead with 20 rpm for 24 hours at room temperature. Undissolved test item was removed by filtration with a membrane filter (0.45 µm, RC, Machery-Nagel).
- Vehicle: Elendt M4, according too ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Daphnia magna Straus (Clone 5)
- Source: lnstitut für Wasser-, Boden- und Lufthygiene (WaBolu)
- Breeder: DR.U. NOACK-LABORATORIEN, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
- Feeding during test: Daily feeding per test vessel with Pseudokirchneriella subcapitata (0.106 - 0.304 mL) and Desmodesmus subspicatus (0.189 - 0.257 mL) suspension was provided as food corresponding to 0.2 mg C per Daphnia and day.
ACCLIMATION
- Acclimation period: At least 2h in dilution water
- Acclimation conditions: same as test
- Type and amount of food: At least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 10^6 cells/mL - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Hardness:
- 146 - 180 mg/L CaCO3
- Test temperature:
- 20.6 - 22.0°C
- pH:
- 7.67 - 8.08
- Dissolved oxygen:
- 5.08 - 8.72 mg/L
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/L
Measured Concentration: 16.1 µg/L (geometric mean measured concentration) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers 100 mL capacity
- Volume of test medium: 50 mL
- Type : open
- Renewal rate of test solution: renewal 3 times per week, i.e. after 48 and 72 hours
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Culture medium Elendt M4, according to ELENDT ( 1990), modified to a total hardness of 160 to 180 mg CaC03/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: once within 7 days
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8h light/dark cycle
- Light intensity: Max. 20 µE m-2 s-1
TEST CONCENTRATIONS
- Range finding study: A non GLP preliminary range finding test was carried out at the test facility as acute immobilisation test to Daphnia magna STRAUS. A limit loading rate of 100 mg/L of the test item was tested under static conditions over a period of 48 h and no immobilisation was seen.
- Reference substance (positive control):
- yes
- Remarks:
- A reference test was conducted as an acute immobilisation test (acc. to DIN 38412 L11 and AQS P 9/2) under static conditions with a test duration of 24h once per month.
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 16.1 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: NOEC = solubility limit
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 16.1 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: NOEC = solubility limit
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- The measured concentrations of the test item at the start of the exposure intervals were in the range of
The average values of living juveniles per parental daphnid were 75 for the control and 76 for the geometric mean measured concentration of 16.1 µg/L after 21 days. The reproductive output of daphnids in the geometric mean measured concentration of 16.1 µg/L was comparable to the reproductive output of daphnids in the control (t-test, p = 0.05).
The coefficient of varation of the number of living offspring produced per parent was 8% for the control and 7% for the geometric mean measured concentrwation of 16.1 µg/L. Generally in a well-run test, the coefficient of varation around the mean number of living offspring per parent animal should be <= 25%.
The intrinsic rates of natural increase (IR) of the surviving parental daphnids accounting for generation time and number of offspring were used for calculation of population growth and maintenance. The intrinsic rates of the geometric mean measured concentration of 16.1 µg/L were comparable to those in the control (t-test, p= 0.05).
No adult mortality was observed during the test period of 21 days. In the geometric mean measured concentration of 16.1 µg/L and in the control, all parental daphnids survived until the end of the test after 21 days.
The first brood was released between days 8 and 9 by all parental daphnids of the control and the geometric mean measured concentration of 16.1 µg/L. At the geomtric mean measured concentration of 16.1 µg/L and the control, 4 broods were produced by all parental daphnids.
The mean dry body weight and total body length of all parental daphnids of the geometric mean measured concentration of 16.1 µg/L and the control were determined at the end of the study. The mean dry body weight of the parental daphnids was 0.92 mg per daphnid for the control and 0.79 mg per daphnid for the geometric mean measured concentration of 16.1 µg/L. The mean body length of the parental daphnids was 5.20 per daphnid for the control and 5.08 mm per daphnid for the geometric mean measured concentration of 16.1 µg/L.
No stillborn juveniles or aborted eggs were observed in the control and in the geometric mean measured concentration of 16.1 µg/L during the exposure period of 21 days.
No males or ephippia (winter eggs) were observed in the control or in the geometric mean measured concentration of 16.1 µg/L.
Water quality parameters (i.e. pH-value, dissolved oxygen concentration, total water hardness and temperature) were within the acceptable limits. - Results with reference substance (positive control):
- The EC50 of the reference item potassium dichromate was 1.80 mg/L (95% confidence limits: 1.52 - 2.22 mg/L) after 24 hours and therefore within the prescribed concentration range of 1.0 - 2.5 mg/L of quality criteria according to AQS P 9/2 (05/1996) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within the recommended rangeof 0.6 - 2.1 mg/L according to OECD-Guideline 202.
- Validity criteria fulfilled:
- yes
- Conclusions:
- No significant effects on the reproductive output or adult mortality were observed in this study. The No Observed Effect Concentration (NOEC) after 21 days was assessed at 16.1 µg/L, which is the maximum solubility level of the test item in the dilution water.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 211. In this study semi-static conditions have been applied. The concentrations of the test item were analytically verified via HPLC-DAD of samples taken at the start of the exposure intervals on days 0, 9, 14, 16 (0 h) and at the end of the exposure intervals on days 2, 12 and 19 (48 or 72 h) of the saturated solution and the control. No significant effects on the reproductive output or adult mortality were observed in this study. The No Observed Effect Concentration (NOEC) after 21 days was assessed at 16.1 µg/L, which is the maximum solubility level of the test item in the dilution water.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 211
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluoro-4'-propyl-1,1'-biphenyl
- EC Number:
- 608-462-0
- Cas Number:
- 303186-20-1
- Molecular formula:
- C22H15F7O
- IUPAC Name:
- 4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluoro-4'-propyl-1,1'-biphenyl
Constituent 1
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- For this endpoint a read across was performed to long term reproductive toxicity study in Daphnia magna for the same compound. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 211. No clinical effects have been observed during the 21 days exposure at a limit concentration of nominal 100 mg/L.
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