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EC number: 262-413-4 | CAS number: 60763-41-9
- 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
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:
- 20 June 2016 - 14 July 2016
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- December 14, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control and 10, 18, 32, 56 and 100% of a saturated solution
- Sampling method: samples (100 mL) were taken from the control and each test group from the freshly prepared bulk test preparation at 0 and 24 hours and from the pooled replicates at 24 and 48 hours.
- Sample storage conditions before analysis: test samples were analyzed on the day of receipt - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: preparation of a saturated solution (direct addition to test medium) - A nominal amount of test item (550 mg) was dispersed in 11 liters of test water with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item was removed by filtration through a 0.2 μm Sartorius Sartopore filter (first approximate 2 liters discarded in order to pre-condition the filter) to give a 100% v/v saturated solution. A series of dilutions was made from this saturated solution to give further test concentrations of 10, 18, 32 and 56% (v/v) saturated solution.
- Controls: test medium without test item
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no - At the start and throughout the test all control and test solutions were observed to be clear colorless solutions.
- Other: Prior to use the test medium was aerated until the dissolved oxygen concentration was approximately air-saturation value. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house laboratory culture
- Feeding during culture:
* Food type: mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension
* Frequency: daily
- Feeding during test: no
- Age at study initiation: young daphnids with an age of < 24 hours
ACCLIMATION
- Acclimation period: no
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Adult daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium in a temperature controlled room maintaining the water temperature at 18 to 22 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Culture conditions ensured that reproduction 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. These young were removed from the cultures and used for testing. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- none
- Hardness:
- 250 mg/L as CaCO3
- Test temperature:
- 21 °C - 22 °C
- pH:
- fresh media: 7.7-7.9
used media: 7.7-8.1 - Dissolved oxygen:
- fresh media: 8.6-9.1 mg O2/L
used media: 8.5-8.8 mg O2/L - Nominal and measured concentrations:
- Based on the results of the range-finding test, performed at nominal test concentration of 0.10, 1.0 10 and 100% (v/v) of a saturated solution (measured concentration in 100% saturated solution was ca. 3.3 mg/L) the following test concentrations were assigned to the definitive test:
Nominal test concentrations (defintive test): 10, 18, 32, 56 and 100% of a saturated solution prepared at a loading rate of 50 mg/L
Measured concentrations: 0.10, 0.10, 0.24, 0.38 and 0.70 mg/L (geometric mean measured concentration)
Geometric mean measured test concentrations were used to calculate effect parameters in order to give a “worst case” analysis of the data. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL glass stoppered conical flasks
- Fill volume: approximately 100 mL (in principle no headspace as test vessels were completely filled and sealed so as to reduce losses due to volatilization)
- Aeration: no
- Renewal rate of test solution: yes, after 24 hours
- 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: ISO medium according to OECD 202
- Culture medium different from test medium: yes - culture medium: Elendt M7
- Intervals of water quality measurement: water temperature, pH and dissolved oxygen concentrations were recorded daily
OTHER TEST CONDITIONS
- Adjustment of pH: yes; where needed, pH was adjusted to pH 7.8+/- 0.2
- Photoperiod: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods
- Light intensity: 464 to 527 Lux
- Other: for renewal at 24 hours, the daphnids transferred by wide bore pipette from the 24-Hour old test media into the fresh test media
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mobility (at 24 and 48 hours)
RANGE-FINDING STUDY
- Test concentrations: 0.10, 1.0, 10 and 100% v/v saturated solution
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (March 2016)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.45 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CI 0.21 - >0.80
- Details on results:
- - Observed sub-lethal effects: reduced movement was observed in the 100% v/v saturated solution test concentration at 24 hours:
- Mortality of control: no
- Other adverse effects control: no
- Effect concentrations exceeding solubility of substance in test medium: no
- Other: Relative to initial [%] ranged from 65 - 130% in the first renewal period, and 95-121% in the second renewal period (calculated by the reviewer).
Individual pH, temperature and dissolved oxygen values remained within acceptable limits throughout the duration of the study. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Test concentrations: 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L
- 48h-EC50: 0.64 mg/L - Reported statistics and error estimates:
- The EC50 value at 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 and the No Observed Effect Concentration at 24 and 48 hours were calculated using the Step-down Cochran-Armitage Test Procedure.
ToxRat Professional was used to perform the statistical analyses. - Validity criteria fulfilled:
- yes
- Remarks:
- 1) In the control, no daphnids became immobilised or showed other signs of disease or stress. 2) The oxygen concentration at the end of the test was ≥3 mg/L in control and test vessels.
- Conclusions:
- The 48h-EC50 value to Daphnia magna was 0.45 mg/L based on geometric mean measured concentrations.
- Executive summary:
A study was performed to assess the acute toxicity of the substance to Daphnia magna. The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 202 and GLP under semi-static conditions. Based on the results of a range-finding test, the following nominal concentrations were tested in the definitive test: untreated control, 10, 18, 32 and 56% (v/v) dilutions of a saturated solution prepared at loading rate of 50 mg/L, as well as the 100% saturated solution. For each concentration and a control group, twenty Daphnia magna (less than 24 hours old) were exposed for 48 hours in air-tight closed vessels. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours. Samples taken from all concentrations at the start and the end of both 24 -hour renewal periods were analysed with a validated GC-FID method. Measured concentrations in used test solutions ranged from 65 -130% of initial in the first renewal period, and from 95 -121% of initial in the second renewal period. Since test concentrations did not remain stable during the 24 -hour renewal periods (i.e. not within 80 -120% of initial), geometric mean measured concentrations were calculated. The range tested based on geometric mean measured concentrations was 0.10, 0.10, 0.24, 0.38 and 0.70 mg/L. The 48h-EC50 value to Daphnia magna was 0.45 mg/L based on geometric mean measured concentrations.
Reference
Table 1. Cumulative Immobilization Data and Observations in the Definitive Test
Nominal Concentration (% v/v Saturated Solution) |
24 Hours |
||||||||||
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
||||||||||
R1 |
R2 |
R3 |
R4 |
Total |
% |
R1 |
R2 |
R3 |
R4 |
||
|
|
|
|
||||||||
Control |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
|
10 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
|
18 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
|
32 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
|
56 |
1 |
0 |
0 |
0 |
1 |
5 |
4 N |
5 N |
5 N |
5 N |
|
100 |
0 |
0 |
0 |
0 |
0 |
0 |
5 R |
5 R |
5 R |
5 R |
|
Nominal Concentration (% v/v Saturated Solution) |
48 Hours |
||||||||||
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
||||||||||
R1 |
R2 |
R3 |
R4 |
Total |
% |
R1 |
R2 |
R3 |
R4 |
||
|
|
|
|
||||||||
Control |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
|
10 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
|
18 |
0 |
0 |
0 |
0 |
0 |
0 |
5 N |
5 N |
5 N |
5 N |
|
32 |
0 |
1 |
0 |
0 |
1 |
5 |
5 N |
4 N |
5 N |
5 N |
|
56 |
1 |
0 |
1 |
1 |
3 |
15 |
4 N |
5 N |
4 N |
4 N |
|
100 |
5 |
5 |
5 |
5 |
20 |
100 |
A/I |
A/I |
A/I |
A/I |
|
R1 – R4 = Replicates 1 to 4
N = No sub-lethal effects observed
R = Reduced movement
A/I = All daphnia immobilized
Verification of Test Concentrations
Chemical analysis of the freshly prepared test preparations at 0 and 24 hours (see Table 3 below) measured test concentrations to range from less than the LOQ to 0.76 mg/L. Analysis of the old or expired test preparations at 24 and 48 hours showed that measured test concentrations ranged from less than the LOQ to 0.73 mg/L, hence it was considered appropriate to calculate the results based on the geometric mean measured test concentrations in order to give a “worst case” analysis of the data.
The geometric mean measured test concentrations were determined to be:
Table 2. Geometric mean measured test concentrations
Nominal Test Concentration (% v/v Saturated Solution) |
Geometric Mean Measured Test Concentration (mg/L) |
10 |
0.10 |
18 |
0.10 |
32 |
0.24 |
56 |
0.38 |
100 |
0.70 |
Table 3. Test sample results
Time Point |
Nominal Concentration of Test Item in Test Sample |
Sample Preparation Factor |
Determined Concentration of Test Item in Test Sample |
cnom |
F |
c |
|
[hours] |
[% v/v Saturated Solution] |
[mg/L] |
|
0 (Fresh) |
Control |
0.1 |
<LOQ |
10 |
0.1 |
0.0695 |
|
18 |
0.1 |
0.173 |
|
32 |
0.1 |
0.279 |
|
56 |
0.1 |
0.465 |
|
100 |
0.1 |
0.756 |
|
24 (Old) |
Control |
0.1 |
0.0681 (<LOQ) |
10 |
0.1 |
0.0905 |
|
18 |
0.1 |
0.112 |
|
32 |
0.1 |
0.227 |
|
56 |
0.1 |
0.305 |
|
100 |
0.1 |
0.659 |
|
24 (Fresh) |
Control |
0.1 |
<LOQ |
10 |
0.1 |
0.0748 |
|
18 |
0.1 |
0.129 |
|
32 |
0.1 |
0.242 |
|
56 |
0.1 |
0.398 |
|
100 |
0.1 |
0.665 |
|
48 (Old) |
Control |
0.1 |
0.0587 (<LOQ) |
10 |
0.1 |
<LOQ |
|
18 |
0.1 |
0.156 |
|
32 |
0.1 |
0.229 |
|
56 |
0.1 |
0.378 |
|
100 |
0.1 |
0.728 |
LOQ = Limit of Quantification = 0.20 mg/L.
LOQ discussion: Recoveries were carried out at 0.1 mg/L, which corresponded to the concentration obtained for the 10% v/v saturated solution. The recoveries were repeated twice and gave an 89% recovery rate with an RSD of 15% (n = 5) and a 69% recovery rate with an RSD of 18% (n = 5). Due to the co-elution of peaks at the retention time of the test item, the recoveries were repeated at 0.2 mg/L and gave a recovery rate of 94% with an RSD of 3.0% (n = 5). The LOQ was therefore assessed as 0.20 mg/L. Sample concentrations at approximately 0.1 mg/L are recoverable, but with a greater degree of imprecision, and are reported for indicative purposes only.
Description of key information
A study was performed to assess the acute toxicity of the substance toDaphnia magna. The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 202 and GLP under semi-static conditions.Based on the results of a range-finding test, the following nominal concentrations were tested in the definitive test: untreated control, 10, 18, 32 and 56% (v/v) dilutions of a saturated solution prepared at loading rate of 50 mg/L, as well as the 100% saturated solution.For each concentration and a control group, twentyDaphnia magna(less than 24 hours old) were exposed for 48 hoursin air-tight closed vessels.The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours.Samples taken from all concentrations atthe start and the end of both 24 -hour renewal periodswere analysed with a validated GC-FID method.Measured concentrations in used test solutions ranged from 65 -130% of initial in the first renewal period, and from 95 -121% of initial in the second renewal period. Sincetest concentrations did not remain stable during the 24 -hour renewal periods (i.e. not within 80 -120% of initial), geometricmean measured concentrations were calculated. The range tested based on geometric mean measured concentrations was 0.10, 0.10, 0.24, 0.38 and 0.70 mg/L.The 48h-EC50 value toDaphnia magnawas 0.45 mg/L based on geometric mean measured concentrations.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.45 mg/L
Additional information
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