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EC number: 617-346-9 | CAS number: 82543-15-5
- 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:
- Jan - Jul 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- EC guideline 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 82543-15-5
- Test material form:
- solid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples for concentration analysis were taken at 0 and 48 h.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The nominal loading of the unfiltered suspension was 100 mg/L which is the highest concentration to be tested according to the guideline. The test concentrations were a saturated solution and 4 dilutions thereof, selected according to a limit and range-finding test where 75% immobilization were found in the saturated solution and no immobilization in 1:100 dilution. For the stock solution 100 mg ZK 38700 were suspended in 1000 mL tap water. Thereafter, the suspension was kept for 1 hours in an ultrasonic bath and stirred for 24 hours. Thereafter, the suspension was filtered through a glassfibre filter. This solution was used as the highest test concentration. Aliquots of the solution were further diluted 1 :2, 1 :4, 1:8 and 1 :16 with tap water in order to prepare the appropriate test concentrations.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Age at study initiation (mean and range, SD): 0-24 h
- Source: Schering AG, Exp. Toxicology, Berlin, Germany
- Feeding during test: no
Study design
- Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 19.6 - 21.1 °C
- pH:
- 7.0 - 8.7
- Dissolved oxygen:
- 8.1 - 9.2 mg/L
- Nominal and measured concentrations:
- measured: 4.4, 8.4, 16.6, 33.5, 66.3 mg/L
- Details on test conditions:
- TEST SYSTEM
- Material, size, headspace, fill volume: 100 mL test vessels
- Volume of solution: 45 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 h light/12 h darkness
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Mobility after 24 and 48 h - Reference substance (positive control):
- no
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 48.9 mg/L
- 95% CI:
- >= 38.2 - <= 59.5
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Reported statistics and error estimates:
- The EC50 for the compound was calculated by the computer program "LogW 1.5, IPDR,
Schering AG, Berlin, Germany.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50 (48 h) of Endiol to Daphnia magna was calculated to be 48.9 mg/L [95% confidence limits 38.2-59.5 mg/L] on the basis of measured concentrations.
- Executive summary:
The purpose of the study was to determine the acute toxicity (immobilization, EC/48 hours) of Endiol (ZK 38700) with Daphnia magna in order to evaluate the aquatic toxicity. Endiol is an intermediate of the synthesis of drospirenone. The study was conducted as a definitive test according to the following guidelines of the OECD, no 202 and the EC guideline 92/69/EEC.
20 juvenile Daphnia magna were used for each test solution of Endiol and 20 for the tap water control. The Daphnia were exposed for a period of 48 hours under static conditions. Immobilization was recorded at 24 hours and 48 hours. Samples for the concentration analysis by HPLC in combination with UV detection were taken at 0 and 48 hours after start of exposure. The analytical result gave a mean concentration of 66.3 mg/L (saturated solution).
Immobilized Daphnia were observed at test concentrations of 33.5 and 66.3 mg/L. The EC50/48 hours of Endiol to Daphnia magna was calculated to be 48.9 mg/L (measured). The highest concentration with no effects on mobility was 16.6 mg/L.
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