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Diss Factsheets
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EC number: 206-825-4 | CAS number: 378-44-9
- 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:
- 2003-2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study following Testing guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Betamethasone
- EC Number:
- 206-825-4
- EC Name:
- Betamethasone
- Cas Number:
- 378-44-9
- Molecular formula:
- C22H29FO5
- IUPAC Name:
- 9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): Betamethasone
- Substance type: Organic
- Physical state: Off-white crystalline powder
- Lot/batch No.: H032754
- Stability under test conditions: The concentration of Betamethasone was measured at 0 and 48 hours by HPLC method
- Storage condition of test material: The sample was stored at ambient temperature, in the container in which it was received, until required for testing
- Other: The substance was received and assigned the Brixham test substance number 03-0210
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility (under test conditions): 20 mg/l was selected as the maximum test concentration
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 20 mg/l
- Sample storage conditions before analysis: The test solution was prepared at 20°C, centrifuged, and directly used for the experiment
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A 2000 ml volume of the nominal test concentration (20 mg/l) was prepared by the direct addition of betamethasone to diluition water
- Eluate: Recostituted water medium, Elendt's M4 Daphnia medium
- Concentration of vehicle in test medium (stock solution and final test solution): test samples were prepared directly in the Eluate
- Evidence of undissolved material (e.g. precipitate, surface film, etc): some suspended white particles that was removed by centrifugation
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Clone 5
- Source: Continuous laboratory cultures; parental stock 22 ± 1 days old. Previously obtained by IRCHA (Institute for Applied Chemical Research), France
- Age at study initiation (mean and range, SD): < 24 hours old, obtained from a single culture vessel
- Method of breeding: Daphnia cultures were fed a defined diet of algae Chlorella vulgaris, strain CCAP 211/12 and commercially available fish food
- Feeding during test: daphnia were not fed during the course of the study
Study design
- Test type:
- static
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- Assessment was made at 24 and 48 h after the commencement of the test
Test conditions
- Hardness:
- Media was 252.7 mg/l CaCO3; and the conductivity of the water was 626 μS/cm
- Test temperature:
- Test was carried out at 20 ± 1°C
- pH:
- pH values of Diluition water batch used in the study (M4 2003-13) was 7.96; during the test ranged from 8.05 to 8.12
- Dissolved oxygen:
- 9.2 mg/l
- Nominal and measured concentrations:
- Betamethasone concentration 20 mg/l
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Borosilicate glass beakers of 250 ml
- Type (delete if not applicable): beakers covered with loose fitting glass lids
- Material, size, headspace, fill volume: Each vessel contained 200 ml of test solution providing a depth of approximately 60 mm
- Aeration: Test solution were not aerated during the course of the study
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 20 Daphnia/l
- No. of vessels per concentration (replicates): 4 vessels for 24 hours analysis and 4 vessels for 48 hours analysis
- No. of vessels per control (replicates): 4 vessels for 24 hours analysis and 4 vessels for 48 hours analysis
- No. of vessels per vehicle control (replicates):
- Biomass loading rate:
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Batch number M4 2003-13
- Total organic carbon: 0.77 mg/l
- Particulate matter:
- Metals:
- Pesticides: 0.0286 μg/l
- Chlorine:
- Alkalinity: as CaCO3 40.2 mg/l
- Ca/mg ratio:
- Conductivity: @25°C 626 μS/cm
- Culture medium different from test medium:
- Intervals of water quality measurement:
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 hours light: 8 hours dark, with 20 minute dusk and dawn transition period
- Light intensity:
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations: 20 mg/l
- Results used to determine the conditions for the definitive study: - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: HPLC analysis
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: HPLC analysis
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: HPLC analysis
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: no abnormality observed
- Observations on body length and weight: no abnormality observed
- Other biological observations: no abnormality observed
- Mortality of control: none
- Other adverse effects control: no abnormality observed
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no abnormality observed
- Effect concentrations exceeding solubility of substance in test medium: no abnormality observed
Any other information on results incl. tables
Results of single test Betamethasone concentration
Time (hours) | Nominal concentration of betamethasone (mg/l) | Number immobilised per replicate | Total number tested | Total number immobilised | Percentage immobilised | |||
A | B | C | D | |||||
24 | Diluition water control | 0 | 0 | 0 | 0 | 20 | 0 | 0 |
20 | 0 | 0 | 0 | 0 | 20 | 0 | 0 | |
48 | Diluition water control | 0 | 0 | 0 | 0 | 20 | 0 | 0 |
20 | 0 | 0 | 0 | 0 | 20 | 0 | 0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- After 48 hours, there was no effect on mobility at the single test substance concentration of 20 mg/l.
The NOEC based on immobility was 20 mg/l.
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