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EC number: 629-080-0 | CAS number: 161308-34-5
- 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
- Study period:
- 13 May 2019 - 16 Jul 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 28 July 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Correction factor for purity: not required
- Stability at higher temperatures: stable
- Solubility in water: 110 g/L - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All test concentrations and control
- Sampling method: 2.0 mL from the approximate centre of the test vessels at t=0 h and t=72 h.
- Sample storage conditions before analysis: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the test facility.
- At the end of the exposure period, the replicates with algae were pooled at each concentration before sampling.
- Compliance with the quality criteria regarding maintenance of actual concentrations was checked by running a test vessel at 100 mg/L but without algae and samples for analysis were taken at the start and at the end of the test period. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: the test item was completely soluble in test medium at the concentrations tested. Preparation of test solutions started with the highest concentration of 100 mg/L applying a one-hour period of magnetic stirring to accelerate the dissolution of the test item in test medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All test solutions were clear and colorless at the end of the preparation procedure.
- Controls: Test medium without test item or other additives. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Raphidocelis subcapitata (formerly known as Pseudokirchneriella subcapitata)
- Strain: NIVA CHL 1
- Source: In-house laboratory culture
- Age of inoculum at test initiation: 3 days
- Method of cultivation: Algae stock cultures were started by inoculating stock culture medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light (60 to 120 μE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm) in a climate room at a temperature of 21-24°C.
- Stock culture medium: M1 medium, according to NPR 6505
- Pre-culture: 3 days before the start of the test, cells from the algal stock culture were inoculated in pre-culture medium at a cell density of 1 x 10^4 cells/mL. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use.
- Pre-culture medium and test medium: M2 medium, according to OECD 201 - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Hardness:
- 0.24 mmol/L (24 mg CaCO3/L)
- Test temperature:
- 22 - 23°C
- pH:
- Control: 8.0 (t=0 h); 7.9 (t=72 h)
100 mg/L: 8.0 (t=0 h); 7.8 (t=72 h) - Nominal and measured concentrations:
- Nominal: 100 mg/L
Measured: 100 mg/L (with algae) at t=0 h 115 mg/L and at t=72h 121 mg/L; 100 mg/L (without algae) at t=0 h 117 mg/L and at t=72 h 121 mg/L
Based on these results, the nominal exposure concentrations were used to determine the effect parameters. See Table 3 in 'Any other information on results incl. tables' for details. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL, all-glass with aluminium caps, perforated for ventilation, containing 50 mL of test solution
- Aeration: no
- Initial cells density: 10^4 cells/mL
- Control end cells density: 260 x 10^4 cells/mL
- Replicates: 6 replicates of the control and the test concentration, 1 extra replicate of the test concentration without algae.
GROWTH MEDIUM
- Standard medium used: yes, M2
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M2, formulated using tap-water purified by reverse osmosis.
- Intervals of water quality measurement:
pH: at the beginning and at the end of the test, for the limit concentration and the control.
Temperature of medium: continuously in a temperature control vessel.
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod and light intensity: Continuously using TLD-lamps with a light intensity within the range of 85 - 88 µE.m-2.s-1.
- Incubation: Vessels were distributed at random in the incubator and daily repositioned. During incubation the algal cells were kept in suspension by continuous shaking.
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: At the beginning of the test, cells were counted using a microscope and a counting chamber. Thereafter, cell densities were determined by spectrophotometric measurement of samples at 680 nm using a spectrophotometer with immersion probe (path length = 10 mm). Test medium was used as blank and the extra replicates, without algae, as background for the treated solutions.
- Appearance of the cells: At the end of the limit test, microscopic observations were performed on the 100 mg/L test concentration and the control to observe for any abnormal appearance of the algae. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (performed Apr 2019)
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Microscopic observations at the end of the test revealed a normal and healthy appearance of the algal cells exposed to 100 mg/L when compared to the control.
- No significant differences were recorded between the values for growth rate and yield at any of the test concentrations when compared to the control group. No inhibition of growth rate and yield was observed. See Table 1 and Table 2 in 'Any other information on results incl. tables' for details.
- Analytical results: The measured concentrations were at 115 and 121% relative to the nominal concentrations at the start and end of the test, respectively. The concentrations in the samples without algae were comparable, i.e. were 117 and 121% relative to the nominal concentrations at the start and end of the test, respectively. The presence of biomass thus had no effect on the test item concentrations. Based on these results and the minimal exceedance above the 120% limit (121%) given in the study plan, effect parameters were expressed as analytically confirmed nominal concentrations.
- All water quality parameters remained within the requirements as laid down in the study plan throughout the test. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- The EC50 for growth rate inhibition (72h-ErC50) was 1.11 mg/L with a 95% confidence interval ranging from 1.10 - 1.13 mg/L. The historical ranges for growth rate inhibition lie between 0.86 and 2.3 mg/L. Hence, the 72h-ErC50 for the algal culture tested corresponds with this range. - Reported statistics and error estimates:
- NOEC and ECx calculations:
An effect was considered to be significant if statistical analysis of the data obtained for the test concentration compared with those obtained in the negative control revealed significant inhibition of growth rate or inhibition of yield (Two-sample Mann-Whitney U-test Procedure, α=0.05, one-sided, smaller).
The ECx-values could not be determined because no algal growth inhibition was obseved.
ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analysis. - Validity criteria fulfilled:
- yes
- Remarks:
- See 'Overall remarks' for details on validity criteria
- Conclusions:
- No biologically relevant inhibition of growth rate or yield was recorded at the limit concentration tested (100 mg/L). The 72h-ErC50 and 72h-EyC50 values were determined to be >100 mg/L (analytically confirmed nominal concentration).
The 72h-NOEC for both growth rate inhibition and yield inhibition was 100 mg/L. - Executive summary:
In a 72h toxicity study conducted in accordance with OECD guideline 201, freshwater algae (Pseudokirchneriella subcapitata) were exposed to 100 mg/L and an untreated control (both 6 replicates).
The exposure concentration was, both with and without algae, analytically confirmed to be 115 -121% of nominal throughout the test. Therefore, nominal exposure concentrations were used to determine the effect parameters. No inhibition of growth rate or yield was recorded at the tested limit concentration of 100 mg/L. The 72h-ErC50 and 72h-EyC50 values were beyond the range tested, i.e. exceeded an analytically confirmed nominal concentration of 100 mg/L. The 72h-NOEC for both growth rate inhibition and yield inhibition was 100 mg/L. The study met all validity criteria, and is considered reliable without restriction.
Reference
Table 1: Mean growth rate and yield, inhibition of growth rate and yield
Nominal concentration (mg/L) | Mean growth rate 0-72 h (day-1, ± SD) | Inhibition of growth rate (%) | Mean yield 0-72 h (x104cells/mL, ± SD) | Inhibition of yield (%) |
Control | 1.854 ± 0.0126 | - | 259.881 ± 9.8956 | - |
100 | 1.861 ± 0.0371 | -0.35 | 266.189 ± 27.2355 | -2.4 |
Table 2: Individual cell densities (x104 cells/mL)
|
| 0 h | 24 h | 48 h | 72 h |
Control | Replicate 1 | 1.000 | 9.804 | 50.189 | 259.470 |
| Replicate 2 | 1.000 | 11.572 | 56.371 | 272.964 |
| Replicate 3 | 1.000 | 10.257 | 53.249 | 248.909 |
| Replicate 4 | 1.000 | 8.828 | 51.245 | 259.304 |
| Replicate 5 | 1.000 | 9.987 | 54.247 | 272.109 |
| Replicate 6 | 1.000 | 9.235 | 52.548 | 252.530 |
| Mean | 1.000 | 9.947 | 52.975 | 260.881 |
| St. dev | 0.000 | 0.951 | 2.198 | 9.896 |
| CV | 0.000 | 9.556 | 4.150 | 3.793 |
|
|
|
|
|
|
Test item | Replicate 1 | 1.000 | 10.005 | 52.221 | 275.542 |
| Replicate 2 | 1.000 | 9.310 | 48.289 | 212.472 |
| Replicate 3 | 1.000 | 10.194 | 56.865 | 277.057 |
| Replicate 4 | 1.000 | 10.688 | 58.805 | 285.466 |
| Replicate 5 | 1.000 | 10.447 | 56.038 | 281.184 |
| Replicate 6 | 1.000 | 10.297 | 54.695 | 271.415 |
| Mean | 1.000 | 10.157 | 54.486 | 267.189 |
| St. dev | 0.000 | 0.475 | 3.750 | 27.236 |
| CV | 0.000 | 4.675 | 6.882 | 10.193 |
Table 3: Analytical results dilution factor into account. Samples might be contaminated in course of sampling. #: sample without algae
Time of sampling (h) | Nominal concentration (mg/L) | Analyzed concentration (mg/L) | Relative to nominal (%) | Relative to initial (%) |
0 | 0 | n.d. | n.a. | - |
| 100 | 115 | 115 | - |
| 100# | 117 | 117 | - |
72 | 0 | 0.0074* | n.a. | n.a. |
| 100 | 121 | 121 | 105 |
| 100# | 121 | 121 | 103 |
n.d.: Not detected; n.a.: Not applicable; *: The maximum contribution to the 100 mg/L samples was 0.0066% taking the dilution factor into account. Samples might be contaminated in course of sampling. #: sample without algae
Description of key information
No biologically relevant inhibition of growth rate or yield was recorded at the limit concentration tested (100 mg/L). The 72h-ErC50 and 72h-EyC50 values were determined to be >100 mg/L (analytically confirmed nominal concentration).
The 72h-NOEC for both growth rate inhibition and yield inhibition was 100 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 100 mg/L
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
In a 72h toxicity study conducted in accordance with OECD guideline 201, freshwater algae (Pseudokirchneriella subcapitata) were exposed to 100 mg/L and an untreated control (both 6 replicates).
The exposure concentration was, both with and without algae, analytically confirmed to be 115 -121% of nominal throughout the test. Therefore, nominal exposure concentrations were used to determine the effect parameters. No inhibition of growth rate or yield was recorded at the tested limit concentration of 100 mg/L. The 72h-ErC50 and 72h-EyC50 values were beyond the range tested, i.e. exceeded an analytically confirmed nominal concentration of 100 mg/L. The 72h-NOEC for both growth rate inhibition and yield inhibition was 100 mg/L. The study met all validity criteria, and is considered reliable without restriction.
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