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EC number: 643-080-8 | CAS number: 24389-25-1
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese national standard
- Version / remarks:
- Testing method relating to the new chemical substances, etc. (Yakushokuhatsu No. 1121002, Heisei 15-11-13 Seikyoku No. 2, Kanpokihatsu No. 031121002 on November 21, 2003).
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Principles of method if other than guideline:
- To assess the toxicity of the test substance by conducting algal growth inhibition test in Pseudokirchneriella subcapitata for notification of the new chemical substance under the Chemical Substance Control Law (CSCL) in Japan.
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- At the start of exposure and 72 hours after the start of exposure, test substance concentrations in the test solution of all test groups and in the test culture solution were analyzed by high performance liquid chromatography-mass spectrometry (LC/MS).
At the start of exposure
Test solution: An aliquot of the test solution was sampled from all test vessels at each test group and mixed.
Sampling, 1.5 mL of the test solution (appropriately diluted with purified water)
LC/MS measurement
At 24, 48 and 72 hours after the start of exposure
Test culture solution: An aliquot of the test solution was sampled from all test vessels at each test group and mixed.
Centrifuge (3000 rpm, 10 minutes, equipment; Hitachi Koki Co., Ltd., Type CR21E)
Supernatant (appropriately diluted with purified water*) 1.5 mL
LC/MS measurement
*: Diluted when the estimated concentration was over the range of the calibration curve. - Vehicle:
- no
- Details on test solutions:
- Preparation of the stock solution
Sampling volume = 100 mg
Test water = Medium (22°C)
Final volume = 1000 mL
Vessel = Volumetric flask
Concentration = 100 mg/L
Mixing method = Stirring by stirring bar (for 3 minutes), tightly sealed.
Preparation of the test solution
The stock solution was collected as shown in below table and diluted with test water, and used as the test solution.
Final volume = 0.10 L
Vessel = 300 mL glass erlenmeyer flask (IWAKI), (with breathable silicone rubber stopper)
Mixing method = Hand shaking
Common ratio for concentration = 2.15
Replication = 6 vessels/control group, 3 vessels/concentration group
(The following concentration is shown to match minimum digits number.) - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Single-cell green algae
- Strain: ATCC22662
- Source (laboratory, culture collection): American Type Culture Collection
- Method of cultivation: Asceptically subcultured with Gorham's medium. Sterility was periodically (approximately every 6 month) confirmed by bacteriological examination.
ACCLIMATION
- Culturing media and conditions (same as test or not): same as test
- Any deformed or abnormal cells observed:No - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- Not applicable
- Test temperature:
- 22°C
- Nominal and measured concentrations:
- 0, 1.0, 22, 4.6, 10, 22, 46, 100 mg/L (Nominal)
0, 0.896, 1.97, 3.96, 8.46, 19.3, 39.8 and 85.1 mg/L (Time weight mean average) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 300mL glass erlenmeyer flask with breathable silicone rubber stopper
- Type (delete if not applicable): open
- Fill volume: 100 mL/vessel
- Renewal rate of test solution (frequency/flow rate): not applicable (static test)
- Initial cells density: 5 x 10^3 cells/mL:
- No. of vessels per concentration (replicates): 3 vessels
- No. of vessels per control (replicates): 6 vessels
GROWTH MEDIUM
- Standard medium used: yes (as per guideline)
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: not adjusted
- Photoperiod: continuous illumination
- Light intensity and quality :65-75 μE/m2/s, continuous illumination with white fluorescent light (around the surface of test solution)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Measurement of biomass
At 24, 48 and 72 hours after the start of exposure, 1.0 mL of test culture solution (0.5 mL at 72 hours) was collected from each test vessel, mixed with 9.0 mL of electrolyte solution for particle counter (9.5 mL at 72 hours), and then biomass was measured using particle counter.
Colour observation of the test culture solution and cell morphology observation
At the start of exposure, 24, 48 and 72 hours after the start of exposure, color of test culture solution was observed by comparison with the reserved vessel. At 72 hours after the start of exposure, cell morphology observation was also conducted using microscope.
Measurement of test environment
pH at the start of exposure was measured by collecting aliquots of the test solution from reserved vessel of each test group, and pH at 72 hours after the start of exposure was measured by test culture solution from a vessel (No. 1) of each test group. Temperature, light intensity and number of rotation in the incubator were measured once daily during exposure period.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Justification for using less concentrations than requested by guideline: not applicable
Range finding study:
- Test concentrations: 0, 0.1, 1, 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (performed every 6 month to confirm sensitivity of the test system)
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 85.1 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 8.46 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- From the results of colour observation of the test culture solution, tendency of increasing degree of green over time was observed at all test concentration groups.
From the results of cell morphology observation by microscope at 72 hours after the start of exposure, change of cell morphology (contraction, swelling, rupture and etc.,) and cell aggregation were not observed, and there was no difference compared with the control group. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Reported statistics and error estimates:
- NOEC were determined using one-way analysis of variance (1-way ANOVA, = 0.05) and Williams multiple comparison ( = 0.05, two-sided) after the homogeneity of variance was confirmed by Bartlett s test ( = 0.01).
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item is of low toxicity to aquatic algae under the condition of the test. EC50 value was greater than the maximum tested concentration.
Reference
Table 1: Growth Inhibition (%)
Test group | Nominal Concentration [mean measured conc.] |
Growth rate | ||
mg/L | Vessel no. | Rate (0 -72h) | Inhibition (%) (0 -72h) |
|
Control | - | 1 2 3 4 5 6 Average SD CV |
0.0881 0.0855 0.0856 0.0838 0.0821 0.0861 0.0852 0.0021 2.5 |
|
1 | 1.0 [0.896] |
1 2 3 Average SD |
0.0872 0.0858 0.0834 0.0855 0.0019 |
-0.4 |
2 | 2.2 [1.97] |
1 2 3 Average SD |
0.0875 0.0855 0.0829 0.0853 0.0023 |
-0.1 |
3 | 4.6 [3.96] |
1 2 3 Average SD |
0.0849 0.0795 0.0853 0.0832 0.0032 |
2.3 |
4 | 10 [8.46] |
1 2 3 Average SD |
0.0820 0.0819 0.0823 0.0821 0.0002 |
3.6 |
5 | 22 [19.3] |
1 2 3 Average SD |
0.0747 0.0753 0.0755 0.0752 0.0004 |
11.7** |
6 | 46 [39.8] |
1 2 3 Average SD |
0.0707 0.0688 0.0729 0.0708 0.0021 |
16.9** |
7 | 100 [85.1] |
1 2 3 Average SD |
0.0660 0.0633 0.0660 0.0651 0.0016 |
23.6** |
** significant difference (a = 0.01) from control
Description of key information
In an GLP-compliant study conducted with analytical monitoring in accordance with a standard method equivalent to the OECD guideline, the toxicity of the test item to algae was assessed. It was not possible to determine the 72h EC50 value as this was greater than the highest concentration tested (100 mg/L - nominal; 85.1 mg/L - measured Time Weighted Average). The 72h NOEC (growth rate) was determined to be 8.46 mg/L. This value will be used in the Chemical Safety Assessment
.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 8.46 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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