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EC number: 208-865-8 | CAS number: 544-19-4
- 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:
- 2019-12-02 to 2020-01-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- No. 440/2008
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- April 2004
- GLP compliance:
- yes
Test material
- Reference substance name:
- Copper diformate
- EC Number:
- 208-865-8
- EC Name:
- Copper diformate
- Cas Number:
- 544-19-4
- Molecular formula:
- CH2O2.1/2Cu
- IUPAC Name:
- copper diformate
- Test material form:
- solid: particulate/powder
- Details on test material:
- blue in colour
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- During final test:
- Concentrations: control and all test concentration
- Sampling method: fresh samples from the bulk test preparation at 0 and 24 hours/ aged samples from pooled replicates at 24 and 48 hours
- Sample storage conditions before analysis: freshly prepared and aged sample of 24 hours were immediately analysed/ aged 48 hours samples were initially frozen prior to analysis
Test solutions
- Vehicle:
- no
- Details on test solutions:
- A nominal amount of test item (50 mg) was dissolved in test water with the aid of ultrasonication for 1 minute and the volume adjusted to 500 mL to give a 100 mg/L stock concentration. This was diluted to make a 10 mg/L stock concentration from which a series of dilutions was made to give the test concentrations of 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L.
The stock solution and prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation/Stage and instar at study initiation: first instar daphnids < 24 hours
- Source: in-house laboratory cultures
- Method of breeding (Culture conditions) : reproduction of adult daphnids was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old.
- Holding conditions (Culture): temperature: 18-22 °C; light: 16 hours a day; feeding: daily with a mixture of algae and GEMMA Micro 300 fish food suspension
- Feeding during test: no
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 250 mg/L CaCo3
- Test temperature:
- 20 to 21°C
- pH:
- 7.9 to 8.1
- Dissolved oxygen:
- 8.7 to 9.1
- Salinity:
- not applicable
- Nominal and measured concentrations:
- - Nominal: 0.010, 0.032, 0.10, 0.32 and 1.0 mg test item/L
- Geometric mean measured test concentrations for copper: 0.0053, 0.080, 0.020, 0.089 and 0.31 mg copper/L
- Geometric mean measured test concentrations for copper diformate: 0.013, 0.020, 0.048, 0.21 and 0.74 mg copper diformate/L - Details on test conditions:
- Test System
- Test vessel: glass ware, size: 240 mL beakers containing 100 mL of test solution or control media
- Aeration: none
- Medium: reconstituted water (ISO-medium)
- No. of organisms/vessel: 5
- Replicates: 4 per test concentration and control
- photoperiod: 16 h light: 8 h darkness (with 20 minute dawn and dusk transition periods)
- one water renewal after 24 hours of exposure
- pH values: 0/24 h, fresh media: 7.9-8.1, 24/48 h, aged media: 7.9-8.1
- Oxygen value: 0/24 h, fresh media: 8.8-9.0 mg/L, 24/48 h, aged media: 8.7-9.1
- Temperature: 18-22 +-1 °C
Test concentrations:
- initial range finding test: 0.10, 1.0, 10 and 100 mg/L -> toxicity at all test concentrations
- second range finding test: 0.0010, 0.0050, 0.010 and 0.10 mg/L
- final test: 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.048 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- effect concentration based on copper diformate
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.21 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- effect concentration based on copper diformate
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.11 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- effect concentration based on copper diformate
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% Confidence Limits 0.079 - 0.15 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.18 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Remarks:
- effect concentration based on copper diformate
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.02 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Remarks:
- copper
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.089 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Remarks:
- copper
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.046 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Remarks:
- copper
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% Confidence Limits 0.033 - 0.063 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.078 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Remarks:
- copper
- Basis for effect:
- mobility
- Details on results:
- At the start and throughout the test all control and test solutions were observed to be clear colorless solutions.
Temperature was maintained at 20 to 21 °C throughout the test, while there were no treatment related differences for oxygen concentration or pH.
Throughout the test the light intensity was observed to be in the range 847 to 1034 Lux.
No sub-lethal effects of exposure were observed throughout the test. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50(48h): 0.71 mg/L (95% CI: 0.61 - 0.81 mg/L)
- Other: The results from the positive control with potassium dichromate were within the normal range for this reference item. - Reported statistics and error estimates:
- The EC50 values and associated confidence limits at 24 and 48 hours and the slope of the response curve and its standard error were calculated by Probit analysis using Linear Maximum-Likelihood regression. The Lowest Observed Effect Concentration (LOEC) and the No Observed Effect Concentration (NOEC) were calculated using the Step-down Cochran-Armitage test. All results were calculated using the ToxRat Professional computer software package (TOXRAT).
Any other information on results incl. tables
Range finding test:
Immobilization was observed at all test concentrations in the initial range-finding test, 70% immobilization at the test concentration of 0.10 mg/L and 100% immobilization at test concentrations of 1.0, 10 and 100 mg/L.
In the second range-finding test, no immobilization was observed at test concentrations of 0.0010, 0.0050 and 0.010 mg/L, however; 30% immobilization was observed at 0.10 mg/L.
Reduced mobility was observed at a test concentration of 0.10 mg/L.
Based on this information nominal test concentrations of 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L were selected for the definitive test.
Chemical analysis of the test preparations from the second range-finding test showed measured test concentrations of copper to range from 93 to 525% of the nominal concentration at 0 hours and 64 to 394% of the nominal concentration at 48 hours. High values obtained at lower concentrations were considered to be due to proximity to the limit of quantification (LOQ) for the method of analysis employed.
Main Test:
Verification of Test Concentrations - copper:
ICP analysis for copper of the fresh test preparations at 0 hours showed measured test concentrations to range from 0.011 to 0.38 mg/L and of less than the limit of quantification (LOQ) of the analytical method employed, determined to be 0.0078 mg/L, to 0.38 mg/L at 24 hours. ICP analysis for copper of the corresponding aged test preparations showed measured test concentrations of less than the LOQ to 0.25 mg/L at 24 hours and of less than the LOQ to 0.25 mg/L at 48 hours.
For the control and all test groups at 0 hours, duplicate samples which had been stored frozen were provided for analysis due to the detection of trace levels of copper in the control and achieved values outside of the acceptable 80-120% of nominal range. As the duplicate values were not significantly different to the initial values, the mean values were used for calculation and reporting purposes.
It was considered that it was appropriate to base the results on the geometric mean measured test concentrations in order to give a "worst case" analysis of the data. The average geometric mean measured test concentrations were determined to be 0.0053, 0.080, 0.020, 0.089 and 0.31 mg/L for copper.
Immobilization - copper:
The slopes and their standard errors of the response curves at 24 and 48 hours were 8.9 (standard error = 0.73) and 4.5 (standard error = 0.066) respectively.
Verification of Test Concentrations - copper diformate:
ICP analysis for Copper Diformate of the fresh test preparations at 0 hours showed measured test concentrations to range from 0.027 to 0.92 mg/L and of less than the limit of quantification (LOQ) of the analytical method employed, determined to be 0.019 mg/L, to 0.91 mg/L at 24 hours. ICP analysis for Copper Diformate of the corresponding aged test preparations showed measured test concentrations of less than the LOQ to 0.61 mg/L at 24 hours and of less than the LOQ to 0.60 mg/L at 48 hours.
For the control and all test groups at 0 hours, duplicate samples which had been stored frozen were provided for analysis due to the detection of trace levels of Copper Diformate in the control and achieved values outside of the acceptable 80-120% of nominal range. As the duplicate values were not significantly different to the initial values, the mean values were used for calculation and reporting purposes.
It was considered that it was appropriate to base the results on the geometric mean measured test concentrations in order to give a "worst case" analysis of the data. The average geometric mean measured test concentrations were determined to be 0.013, 0.020, 0.048, 0.21 and 0.75 mg/L for Copper Diformate.
Immobilization - copper diformate:
The slopes and their standard errors of the response curves at 24 and 48 hours were 9.0 (standard error = 0.71) and 4.6 (standard error = 0.065) respectively.
Table 1: Cumulative immobilization data after 24 and 48 h in the definitive test
Nominal test item Concentration [mg/L] |
24 h |
|||||
Cumulative ImmobilizedDaphnia(Initial Population: 5 daphnids per replicate) |
||||||
R1 |
R2 |
R3 |
R4 |
Total |
% |
|
24 h |
||||||
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0.010 |
0 |
0 |
0 |
0 |
0 |
0 |
0.032 |
0 |
0 |
0 |
0 |
0 |
0 |
0.10 |
0 |
0 |
0 |
0 |
0 |
0 |
0.32 |
0 |
4 |
5 |
5 |
14 |
70 |
1.0 |
5 |
5 |
5 |
5 |
20 |
100 |
|
||||||
48 h |
||||||
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0.010 |
0 |
0 |
0 |
0 |
0 |
0 |
0.032 |
0 |
0 |
0 |
0 |
0 |
0 |
0.10 |
1 |
0 |
0 |
0 |
1 |
5 |
0.32 |
3 |
5 |
5 |
5 |
18 |
90 |
1.0 |
5 |
5 |
5 |
5 |
20 |
100 |
Table 2: Analytical results of test sample measurements
Time point |
Nominal concentration of test item in test sample |
Determined concentration if copper in test sample |
Determined concentration if test item in test sample |
Percentage of nominal concentration |
[hours] |
[mg/L] |
[mg Cu/L] |
[mg test item/L] |
[%] |
0 h (test start) |
Control |
0.0105 (< LOQ) |
0.0253 (< LOQ) |
- |
0.01 |
0.0135 |
0.0327 |
327 |
|
0.032 |
0.0187 |
0.0452 |
141 |
|
0.1 |
0.0424 |
0.102 |
102 |
|
0.32 |
0.128 |
0.310 |
97 |
|
1.0 |
0.382 |
0.922 |
92 |
|
P. Rec 1 |
0.100 |
0.108 |
- |
108 |
P. Rec 2 |
0.100 |
0.108 |
- |
108 |
|
||||
24 h (aged) |
Control |
< LOQ |
< LOQ |
- |
0.01 |
< LOQ |
< LOQ |
- |
|
0.032 |
< LOQ |
< LOQ |
- |
|
0.1 |
0.0116 |
0.0279 |
28 |
|
0.32 |
0.0619 |
0.150 |
47 |
|
1.0 |
0.251 |
0.607 |
61 |
|
P. Rec 1 |
0.100 |
0.103 |
- |
103 |
P. Rec 2 |
0.100 |
0.102 |
- |
102 |
|
|
|
|
|
24 h (fresh) |
Control |
< LOQ |
< LOQ |
- |
0.01 |
< LOQ |
< LOQ |
- |
|
0.032 |
0.0139 |
0.0336 |
105 |
|
0.1 |
960.385 |
0.0930 |
93 |
|
0.32 |
0.127 |
0.306 |
96 |
|
1.0 |
0.378 |
0.914 |
91 |
|
|
||||
48 h (aged) |
Control |
< LOQ |
< LOQ |
- |
0.01 |
< LOQ |
< LOQ |
- |
|
0.032 |
< LOQ |
< LOQ |
- |
|
0.1 |
0.00836 |
0.0202 |
20 |
|
0.32 |
0.0624 |
0.151 |
47 |
|
1.0 |
0.249 |
0.601 |
60 |
|
P. Rec 1 |
0.100 |
0.0985 |
- |
99 |
P. Rec 2 |
0.100 |
0.102 |
- |
102 |
Note: The concentrations quoted for the procedural recovery samples are the actual fortified concentrations of copper. The corresponding nominal concentration values relate to the percentage of fortified concentration recovered.
P. rec = procedural recovery; LOQ = limit of quantification (0.0078 mg/L for copper / 0.019 mg/L for test item); - = not applicable
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Exposure of freshwater invertebrate Daphnia magna to the test item has been investigated and gave the following results:
Based on copper: EC50 48h: 0.046 mg/L
Based on copper diformate: EC50 48h: 0.11 mg/L
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