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EC number: 610-388-9 | CAS number: 478945-46-9
- 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:
- From 2004-02-09 to 2004-06-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,5-dimethyl 3-methyl-9-oxo-2,4-bis(pyridin-2-yl)-7-[(pyridin-2-yl)methyl]-3,7-diazabicyclo[3.3.1]nonane-1,5-dicarboxylate dichloroiron hydrate
- EC Number:
- 610-388-9
- Cas Number:
- 478945-46-9
- Molecular formula:
- C28H31N5O6FeCl2
- IUPAC Name:
- 1,5-dimethyl 3-methyl-9-oxo-2,4-bis(pyridin-2-yl)-7-[(pyridin-2-yl)methyl]-3,7-diazabicyclo[3.3.1]nonane-1,5-dicarboxylate dichloroiron hydrate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: S2539801
- Expiration date of the lot/batch:
- Purity test date: 2004-11-12
RADIOLABELLING INFORMATION (if applicable) no
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
ambient/dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING: no
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0-10-18-32-56-100 mg/L
- Sampling method: analysis was carried out at 0H, 24H (old and new) and 48H to assess the satisfactory achieved concentration and stability of the test concentrations of 0, 10, 18, 32, 56 and 100 mg/L
- Sample storage conditions before analysis: not stated.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: a nominal 1000 mg/L stock was prepared by dissolving 1000 mg of test item in 1000 mL of purified water. test media were prepared by diluting the stock with appropriate volumes of Elendt M7 medium to obtain nominal concentrations of 0, 10, 18, 32, 56 and 100 mg/L. 12 L of Elendt M7 media were isolated and adjusted to pH7.5 using 1M HCl for use as dilution media to ensure that the pH of the test solutions remained below pH8
- Controls:Elendt M7 media
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): not reported.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: not stated
- Source: not stated
- Age of parental stock (mean and range, SD): not stated; juveniles <24H were used for the test
- Feeding during test: no
ACCLIMATION not stated
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 206 +/-14 mg/L as caCO3
- Test temperature:
- 19.7+/-0.4°C
- pH:
- 7.5+/-0.3
- Dissolved oxygen:
- 8.0+/-0.1 mg/L
- Nominal and measured concentrations:
- Nominal: 0-10-18-32-56-100 mg/L
Mean measured: <3-7.30-13.49-23.19-42.93-79.42 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 120 mL crystallising dish, filled with approximately 100 mL tets media
- Aeration: not stated
- Renewal rate of test solution (frequency/flow rate): complete renewal at 24H
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates):4
- Biomass loading rate: 5 daphnia in 100 mL
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M7
- Culture medium different from test medium: not stated
- Intervals of water quality measurement: pH, dissolved oxygen and total hardness of the test media were measured at 0, 24 (old and new) and 48 hours. The temperature in a representative sample of the test vessels was measured daily.
OTHER TEST CONDITIONS
- Adjustment of pH:no
- Photoperiod: 16/8
- Light intensity: normal laboratory light intensity
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mobility at 24 and 48H
VEHICLE CONTROL PERFORMED: not appropriate
RANGE-FINDING STUDY
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- not specified
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 23.7 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 7.3 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: not reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not reported
- Effect concentrations exceeding solubility of substance in test medium: no - Reported statistics and error estimates:
- The EC50 was calculated using the computer application BMPDIN. the program generates where possible, three statistical analyses of the data using the moving average method, the probit method and the binomial method.
Any other information on results incl. tables
An anomalous result was observed in the 10 mg/L (24H new) test solution. the original test sample supplied to chemical analysis had a mean measured concentration of 17.42 mg/L (174.2% nominal). A second test sample of 10 mg/L (24H new) solution was supplied and the original sample re-analysed. The mean measured concentration of the re-analysed test sample was 15.38 mg/L (153.8% nominal) and the concentration of the second sample was 8.06 mg/L (80.6% nominal). Re-analysis of the original sample confirmed that loss of the test compound over time was not significant and suggested that this was not the reason for the lower concentration in the second sample. It was believed that the original sample supplied may have been taken from the wrong test solution flask as the results would appear to correlate more closely with the 18 mg/L test solution. Consequently a mean measured concentration of 8.06 has been taken as being the correct and used in the calculation of the results.
Effect data:
|
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- immobility in control: 0% at 48H; dissolved oxygen: 8.0+/-0.1 mg/L in all vessels
- Conclusions:
- 48H-EC50=23.7 mg/L based on mean measured concentrations.
48H-NOEC=7.3 mg/L based on mean measured concentrations. - Executive summary:
The purpose of the study was to determined the 48H EC50 of the test item to juvenile <24 old Daphnia magna, following to OECD 202 guideline and C2 method and according to GLP. The test was conducted under semi-static conditions. Daphnia magna were not fed during the test. Daphnia were exposed to a range of concentrations of the test item prepared by diluting a concentrated stock solution with Elendt M7 medium. Nominal test concentrations were 0-10-18 32-56-100 mg/L and were determined by liquid chromatography/mass spectrometry. Mean measured test concentrations were <3 -7.30 -13.49 -23.19 -42.93 -79.42 mg/L.
48H-EC50=23.7 mg/L based on mean measured concentrations.
48H-NOEC=7.3 mg/L based on mean measured concentrations.
All validity criteria were fulfilled.
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