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EC number: - | CAS number: -
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 March 2018 to 22 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The water-accommodated fraction (WAF) was prepared for the test. This was done by mixing the nominal load of 10 mg/L (real load = 10.3 mg/L) with the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 μm PTFE filters. The lower treatments were prepared by dilution of this WAF with the corresponding amount of dilution water. This procedure is in agreement with the OECD guidance document no. 23 for the testing of mixtures which are toxic at low loading rates (≤ 1 mg/L). In a non-GLP pre-test at the loading rate 1 mg/L slight toxicity was observed.
The individual preparation of loading rates lower than 1 mg/L is technically not possible and therefore dilution of the WAF is the applicable method. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: STRAUS Berlin.
- Source: Umweltbundesamt Berlin. In-house breeding since 27. September 2007.
- Age: Females aged 0 – 24 hours.
- Feeding during test: no
ACCLIMATION
- Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical.
- Acclimation conditions: Medium: M4-Medium (recipe of ELENDT). Photo period: 16/8 hours, using neon tubes. Temperature: 20 ± 2 °C. Medium renewal twice a week.
- Type and amount of food: Green algae (Desmodesmus subspicatus).
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
- 19.25 hours before the start of the test, the adult animals were separated from the young. 1 hour before test start, the adults were caught with the help of a glass tube, and the new-born daphnia, aged between 0 and 18.25 hours, were sieved from the medium and immediately placed into a beaker containing dilution water. After the settling-in period, animals which showed no apparent damage were used for the test.
- Switching from M4-medium (husbandry) to Dilution water (test) has been shown not to cause any detrimental effects for test daphnia. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 250 mg CaCO3/L
- Test temperature:
- 19.6 - 22.5 °C
- pH:
- 7.6 - 8.1
- Dissolved oxygen:
- 8.2 - 8.7 mg/L
- Nominal and measured concentrations:
- Nominal: 0.46, 1.0, 2.2, 4.6 and 10 mg/L
Calculated concentration from the geometric mean of the measured concentration of the highest tested concentration: 0.1, 0.3, 0.6, 1.2 and 2.6 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers, nominal volume 50 mL, tall shape.
- Renewal rate of test solution (frequency/flow rate): None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 vessels, each containing 20 ± 3 mL test solution
- No. of vessels per control (replicates): 4 vessels, each containing 20 ± 3 mL dilution water
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dilution water (Daphnia medium) with the following specification was used: CaCl2*2H2O 293.80 mg/L, MgSO4*7H2O 123.30 mg/L, NaHCO3 64.80 mg/L, KCl 5.80 mg/L. Resulting hardness in mmol/L: 2.502. Resulting hardness in mg CaCO3/L: 250. After preparation, the dilution water was aerated and the pH was measured. The pH was 7.8.
- Intervals of water quality measurement: The pH, the concentration of dissolved oxygen and the content of DOC in the test solutions were measured at the beginning and at the end of the test.
EFFECT PARAMETERS MEASURED
- After 24 and 48 hours, the immobilised daphnia were counted. Daphnia are considered immobilised when they do not perform any movements or are only able to move their antennae when the beaker is gently agitated. Daphnia which are trapped at the surface of the test solution are also considered immobilised. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.59 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.61 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- IMMOBILITY
- In the blank control, none of the daphnia were immobilised.
ANALYTICAL DETERMINATIONS
- Due to low solubility of test material only in the highest tested concentration (prepared WAF) test material was clearly determinable and was at 26 % of the nominal concentration at the beginning and at the end of the test. The lower concentrations (prepared by dilution of WAF) showed fluctuating DOC values which were similar to those of the blank control. Since toxicity was observed in the three highest concentrations, test material must have been present. Therefore, the determination of the biological results was based on the calculated concentrations from the geometric mean of the measured concentration of the highest tested concentration with the respective dilution factor. Geometric mean is calculated by multiplication of the n participating concentrations and taking the nth root.
VALIDITY
- Immobilisation in the controls may not exceed 10 %: Immobilisation in the controls was 0 %.
- The concentration of dissolved oxygen at the end of the test must be at least 3 mg/L: The lowest concentration of dissolved oxygen at the end of the test was 8.2 mg/L.
- The result of the test is considered valid. - Results with reference substance (positive control):
- - Results with reference substance valid?: Yes
- ECx: The 24h-EC50 value was determined as 1.9 mg/L. The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of potassium dichromate K2Cr2O7 as specified in the OECD guideline.
- Since the fits showed sufficient statistical correspondence of the data with the dose-response-equation, this reference study can be considered valid. - Reported statistics and error estimates:
- The estimation of the biological results was accomplished using the software ToxRat® Professional, version 3.2.1.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this study the EC50 value after 48 hours was 0.61 mg/L. The NOEC and LOEC were 0.3 and 0.6 mg/L, respectively.
- Executive summary:
The toxicity of the test material to aquatic invertebrates was investigated in accordance with the standardised guidelines OECD 202 and EU Method C.2, under GLP conditions.
One valid experiment was performed using Daphnia magna STRAUS.
The study was performed using 5 concentrations of the test material ranging from 0.46 to 10 mg/L. For each test concentration and the blank control, 20 daphnia were exposed to the test material for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.
Three concentrations showed toxicity between 45 and 100 % immobilisation. None of the animals were immobilised in the blank control.
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.
Due to low solubility of test material only in the highest tested concentration (prepared WAF) test material was clearly determinable and was at 26 % of the nominal concentration at the beginning and at the end of the test. The lower concentrations (prepared by dilution of WAF) showed fluctuating DOC values which were similar to those of the blank control. Since toxicity was observed in the three highest concentrations, test material must have been present. Therefore, the determination of the biological results was based on the calculated concentrations from the geometric mean of the measured concentration of the highest tested concentration with the respective dilution factor.
Under the conditions of this study after 48 hours the EC50 value was 0.61 mg/L. The NOEC and LOEC were 0.3 and 0.6 mg/L, respectively.
Reference
Table 1: Immobility
Nominal Concentration (mg/L) |
Immobility 24 Hours |
Immobility 48 Hours |
||||||||
Absolute |
% |
Absolute |
% |
|||||||
Blank control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.46 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2.2 |
1 |
0 |
0 |
0 |
5 |
1 |
1 |
5 |
2 |
45 |
4.6 |
1 |
1 |
0 |
0 |
10 |
5 |
5 |
5 |
5 |
100 |
10 |
4 |
5 |
5 |
5 |
95 |
5 |
5 |
5 |
5 |
100 |
Table 2: Measured Concentrations IC and TC
Nominal Concentration (mg/L) |
Measured TC t = 0 h (mg/L) |
Measured TC t = 48 h (mg/L) |
Measured IC t = 0 h (mg/L) |
Measured IC t = 48 h (mg/L) |
Blank control |
9.83 |
18.91 |
9.37 |
11.44 |
0.46 |
9.78 |
18.78 |
9.41 |
11.69 |
1.0 |
10.02 |
19.87 |
9.50 |
11.98 |
2.2 |
9.92 |
19.85 |
9.41 |
12.14 |
4.6 |
10.34 |
19.37 |
9.42 |
11.60 |
10 |
11.79 |
21.43 |
9.42 |
12.08 |
LOQ (Limit of quantification) TC = 5.43 mg/L
LOQ (Limit of quantification) IC = 2.03 mg/L
Table 3: Measured Concentrations DOC
Nominal Concentration (mg/L) |
Measured DOC (TC-TI) t = 0 h (mg/L) |
Measured DOC (TC-TI) t = 48 h (mg/L) |
Measured DOC Minus Blank Control t = 0 h (mg/L) |
Measured DOC Minus Blank Control t = 48 h (mg/L) |
Blank control |
0.47 |
7.47 |
- |
- |
0.46 |
0.38 |
7.09 |
-0.09 |
-0.38 |
1.0 |
0.52 |
7.89 |
0.05 |
0.42 |
2.2 |
0.51 |
7.71 |
0.05 |
0.24 |
4.6 |
0.92 |
7.77 |
0.45 |
0.30 |
10 |
2.37 |
9.35 |
1.90 |
1.88 |
Table 4: Calculated Test Material Concentrations
Nominal Concentration (mg/L) |
Calculated Concentration Test Material t = 0 h (mg/L) |
Calculated Concentration Test Material t = 48 h (mg/L) |
% of Nominal Concentration t = 0 (%) |
% of Nominal Concentration t = 48 (%) |
Blank control |
- |
- |
- |
- |
0.46 |
-0.1 |
-0.5 |
-28 |
-115 |
1.0 |
0.1 |
0.6 |
7 |
58 |
2.2 |
0.1 |
0.3 |
3 |
15 |
4.6 |
0.6 |
0.4 |
14 |
9 |
10 |
2.6 |
2.6 |
26 |
26 |
Table 5: Geometric Mean
Nominal Concentration (mg/L) |
Geometric Mean of Measured Concentrations (mg/L) |
Calculated Concentration from the Geometric Mean of the Measured Concentration of the Highest Tested Concentration |
Blank control |
- |
- |
0.46 |
n.d. |
0.1 |
1.0 |
0.2 |
0.3 |
2.2 |
0.1 |
0.6 |
4.6 |
0.5 |
1.2 |
10 |
2.6 |
2.6 |
n.d. = not determinable due to mathematical reasons
Description of key information
Under the conditions of this study the EC50 value after 48 hours was 0.61 mg/L. The NOEC and LOEC were 0.3 and 0.6 mg/L, respectively.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.61 mg/L
Additional information
The toxicity of the test material to aquatic invertebrates was investigated in accordance with the standardised guidelines OECD 202 and EU Method C.2, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
One valid experiment was performed using Daphnia magna STRAUS.
The study was performed using 5 concentrations of the test material ranging from 0.46 to 10 mg/L. For each test concentration and the blank control, 20 daphnia were exposed to the test material for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.
Three concentrations showed toxicity between 45 and 100 % immobilisation. None of the animals were immobilised in the blank control.
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.
Due to low solubility of test material only in the highest tested concentration (prepared WAF) test material was clearly determinable and was at 26 % of the nominal concentration at the beginning and at the end of the test. The lower concentrations (prepared by dilution of WAF) showed fluctuating DOC values which were similar to those of the blank control. Since toxicity was observed in the three highest concentrations, test material must have been present. Therefore, the determination of the biological results was based on the calculated concentrations from the geometric mean of the measured concentration of the highest tested concentration with the respective dilution factor.
Under the conditions of this study after 48 hours the EC50 value was 0.61 mg/L. The NOEC and LOEC were 0.3 and 0.6 mg/L, respectively.
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