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EC number: 951-985-7 | 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:
- Experimental Phase: 21 July 2020 to 24 September 2020.
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from the freshly prepared control and test group from the bulk test preparation at 0 and 24 hours and from the old test media (pooled replicates) at 24 and 48 hours for quantitative analysis. The 0-Hour fresh sample was sent for analysis on the day of sampling and the remaining samples were stored frozen prior to being sent for analysis.
Duplicate samples were taken and stored frozen for further analysis if necessary.
All sample bottles were fortified by the addition of 10 mL of acetonitrile in order to stabilise the test item. - Vehicle:
- no
- Remarks:
- Saturated solution used
- Details on test solutions:
- Preliminary solubility work conducted indicated that the test item was practically insoluble in water using traditional methods of preparation e.g. ultrasonication and high shear mixing.
Based on this information the test item was categorised as being a ‘difficult substance’ as defined by the OECD Guidance Document on Aqueous-Phase Aquatic Toxicity Testing of Difficult Test Chemicals (OECD 2019) and a preliminary media preparation trial was conducted as follows:
A nominal amount of test item (550 mg) was dispersed, in duplicate, in 11 litres of Elendt M4 media with the aid of propeller stirring at approximately 1500 rpm for periods of either 24 or 48 hours. After stirring samples were taken for chemical analysis after the following pre-treatments:
• Centrifugation at 10000 g for 30 minutes
• Centrifugation at 40000 g for 30 minutes
• Filtration through a 0.2 μm Gelman Acrocap filter (approximately 100 mL used to pre-condition the filter was discarded)
• Filtration through a 0.2 μm Gelman Acrocap filter (approximately 500 mL used to pre-condition the filter was discarded)
Based on the information obtained as part of the preliminary media preparation trial for the main study the test item was prepared using a saturated solution method of preparation at an initial loading rate of 50 mg/L, stirred for a period of 24 hours prior to the removal of any undissolved test item by filtration through a 0.2 μm Gelman Acrocap filter (first approximate 100 mL discarded) to give a nominal test concentration of approximately 0.11 mg/L. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Source: in house cultures
- Feeding during test : None during exposure to test substance.
- Food type: Each culture was fed with a mixture of algal suspension (Raphidocelis subcapitata) and GEMMA Micro 300 fish food suspension.
- Frequency: Daily
ACCLIMATION
- Acclimation period: none
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS:
Adult daphnids were maintained in 150 mL glass vessels containing 100 mL Elendt M4 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. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 2.5 mmol/L (250 mg/L as CaCO3)
- Test temperature:
- 19 °C to 21 °C
- pH:
- pH range: 7.7 to 8.2 over test period
- Dissolved oxygen:
- Oxygen level range: 8.9 to 9.1 mg O2/L over test period
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 150 ml glass vessels
- Type (delete if not applicable): open (but covered to prevent evaporation)
- Material, size, headspace, fill volume: Each vessel contained 100 mL Elendt M4 medium
- Aeration: No
- No. of organisms per vessel: Five
- No. of vessels per concentration (replicates): Four
- No. of vessels per control (replicates): Four
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 medium in reconstituted water
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods
- Light intemsity: 200 to 1200 lux
- Temperature: temperature-controlled room maintaining the water temperature at 18 to 22 °C
VEHICLE CONTROL PERFORMED: Not applicable
RANGE-FINDING STUDY
- Test concentrations: In the range-finding test Daphnia magna were exposed to a series of nominal test concentrations of 1.0, 10 and 100% v/v saturated solution.
- Results used to determine the conditions for the definitive study: Yes
TEST ITEM CONCENTRATION
Semi-static test conditions were employed in the test in an effort to maintain dissolved test item concentrations. For the test media renewal at 24 hours, the test concentrations were freshly prepared and the daphnids transferred by wide bore pipette from the 24-Hour old test media into the fresh test media. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.12 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.:
- > 0.12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 0.12 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.:
- ca. 0.12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- No sub-lethal effects of exposure were observed throughout the test.
- Results with reference substance (positive control):
- The positive control was run as a separate study used potassium dichromate as the reference item at concentrations of 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L. The positive control was conducted between 23 January 2020 and 07 February 2020.
The results from the positive control with potassium dichromate were within the normal range for the reference item. - Validity criteria fulfilled:
- yes
- Conclusions:
- Exposure of Daphnia magna to the test item gave 48-hour EC50 values based on the geometric mean measured test concentration of greater than 0.12 mg/L. The No Observed Effect Concentration (NOEC) was 0.12 mg/L.
The study showed that there were no toxic effects at saturation. - Executive summary:
Introduction
The study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the following Guideline:
- OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test"
- Method C.2 of Commission Regulation (EC) No. 440/2008 (Acute Toxicity for Daphnia)
Methods
Preliminary solubility work conducted indicated that it was not possible to obtain a testable solution of the test item using traditional methods of preparation e.g., ultrasonication and high shear mixing.
A preliminary media preparation trial indicated that a dissolved test item concentration of approximately 0.11 mg/L was obtained from a saturated solution method of preparation indicating this to be the limit of water solubility of this item under test conditions.
Following a preliminary range-finding test, 20 daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test item at a nominal concentration of 100% v/v saturated solution for 48 hours at a temperature of 19°C to 21°C under semi-static test conditions. The test item solution was prepared by stirring an excess (50 mg/L) of test item in test water using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration through a 0.2 µm to give a 100% v/v saturated solution of the test item. Immobilisation and any adverse reactions to exposure were recorded after 24 and 48 hours.
Results
Chemical analysis of the fresh test preparations showed a measured test concentration of 0.091 mg/L at 0 hour and 0.13 mg/L at 24 hours. Analysis of the old test preparations showed a measured test concentration of 0.12 mg/L at 24 hours and 0.14 mg/L at 48 hours. 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 concentration was determined to be 0.12 mg/L.
There was no immobilisation in 20 daphnids exposed to a test concentration of 0.12 mg/L for a period of 48 hours. The immobilisation data is given in the following table:
Time (hours)
EC50 (mg/l)
24 >0.12 48 >0.12 The NOEC after 24 and 48 hours exposure was 0.12 mg/L.
Observations on Test Item Solubility
At the start and throughout the test all control and test solutions were observed to be clear colourless solutions.
Conclusion
Exposure of Daphnia magna to the test item gave 48 -hour EC50 values based on the geometric mean measured test concentration of greater than 0.12 mg/L. The No Observed Effect Concentration (NOEC) was 0.12 mg/L.
The study showed that there were no toxic effects at saturation.
Reference
Verification of Test Concentrations
Chemical analysis of the fresh test preparations showed a measured test concentration of 0.091 mg/L at 0 hour and 0.13 mg/L at 24 hours. Analysis of the old test preparations showed a measured test concentration of 0.12 mg/L at 24 hours and 0.14 mg/L at 48 hours. 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 concentration was determined to be 0.12 mg/L.
Immobilisation Data
There was no immobilisation in 20 daphnids exposed to a test concentration of 0.12 mg/L for a period of 48 hours. The immobilisation data is given in the following table:
Time (hours) |
EC50 (mg/l) |
24 | >0.12 |
48 | >0.12 |
The NOEC after 24 and 48 hours exposure was 0.12 mg/L.
Observations on Test Item Solubility
At the start and throughout the test all control and test solutions were observed to be clear colourless solutions.
Description of key information
Acute toxicity to aquatic invertebrates data summary.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- > 0.12 mg/L
Additional information
Exposure of Daphnia magna to the test item gave 48-hour EC50 values based on the geometric mean measured test concentration of greater than 0.12 mg/L. The No Observed Effect Concentration (NOEC) was 0.12 mg/L.
The study showed that there were no toxic effects at saturation.
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