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EC number: 944-536-1 | 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
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- March 23 2006, corrected July 28 2011
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- August 24 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Series on Testing and Assessment, No. 23, "Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures"
- Version / remarks:
- December 15 2000
- Qualifier:
- according to guideline
- Guideline:
- other: SANCO/3029/99 rev.4 11/07/00: Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II
- Version / remarks:
- rev.4 11/07/00
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
- Sampling method: Duplicate samples from the freshly prepared media containing algae were taken from all test concentrations and controls at test start. At the end of the test, samples were taken after pouring together the contents of the test beakers of each treatment (containing algae)
- Sample storage conditions before analysis: Samples extracted immediately after sampling, and extracts stored in a refrigerator. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test medium of the highest concentration of 20 mg test item/L prepared by dissolving 20.4 mg test item in 1020 mL of OECD medium by intense stirring for 10 minutes. Other test concentrations prepared by dilution of the highest test concentration.
- Eluate: OECD medium
- Controls: OECD medium
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): None - Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: 61.81 SAG
- Source (laboratory, culture collection): Commercial supplier
- Age of inoculum (at test initiation): 4 days
- Method of cultivation: following test guidelines under standard conditions
ACCLIMATION
- Culturing media and conditions (same as test or not): Same
- Any deformed or abnormal cells observed: None reported - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- None
- Hardness:
- 24 mg/L as CaCO3
- Test temperature:
- 21.9 to 23.1ºC
- pH:
- Test start: 8.1
Test end: 8.8 to 9.5 - Nominal and measured concentrations:
- Nominal: 0.9, 2.0, 4.3, 9.3 and 20 mg/L
Geometric mean measured: 0.119, 0.237, 2.10, 5.36 and 13.1 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 50 mL Erlenmeyer flasks
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: Contain 50 mL test media to minimise headspace, with glass stoppers
- Initial cells density: 5000 cells/mL
- Control end cells density: 72.408 x 1000 cells/mL (mean). Standard deviation 5.680 x 1000 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Deionised water with analytical grade salts added (OECD medium)
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Sterile test conditions: not reported
- Adjustment of pH: None
- Photoperiod: Continuous
- Light intensity and quality: 5125 Lux (Range: 4880 to 5460 Lux)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Density, yield, and growth rate every 24 hours
- Determination of cell concentrations: spectrophotometer
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study: Yes
- Test concentrations: 0.1, 1, 10 and 20 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate tested at least twice per year (last test February 2016)
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 13.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 9.07 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval: 7.33 - 11.3 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 4.76 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95 % confidence interval: 3.90 - 5.81 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.237 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 6.36 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: 95% confidence interval: 3.78 - 10.5 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 2.57 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Remarks on result:
- other: 95 % confidence interval: 1.71 - 3.89 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: 95 % confidence interval: 1.04 - 2.46 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.119 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): No abnormalities observed - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: 0.721, 1.50 and 0.794 mg/L for yield, growth rate and biomass, respectively, at 72 hours - Reported statistics and error estimates:
- Based on the calculated cell densities, the 72 hours ErC50 and EyC50 and the corresponding EC20 and EC10 values and where possible the 95 %-confidence limits were calculated by non-linear regression. For the 72 hours LOEC and NOEC, the calculated growth rates and yields at each test concentration were tested for significant differences compared to the control values by Williams t-test (yield and growth rate).
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 72-hour EyC50 and EyC10 were calculated to be 6.36 mg test item/L and 1.60 mg test item/L, respectively. The 72-hour ErC50 and ErC10 values were calculated to be > 13.1 mg test item/L and 4.76 mg test item/L, respectively.
- Executive summary:
The toxicity of the test item to the green algae Pseudokirchneriella subcapitata was determined in a study following OECD guideline 201. Algae were exposed to nominal concentrations of 0.9, 2.0, 4.3, 9.3 and 20 mg test item/L, equivalent to geometric mean measured concentrations of 0.119, 0.237, 2.10, 5.36 and 13.1 mg test item/L alongside a control. The 72-hour EyC50 and EyC10 were calculated to be 6.36 mg test item/L and 1.60 mg test item/L, respectively. The 72-hour ErC50 and ErC10 values were calculated to be > 13.1 mg test item/L and 4.76 mg test item/L, respectively.
The study is a GLP compliant, guideline experimental study available as an unpublished report. There are no restrictions and it is fully adequate for assessment.
Reference
Summary of Analytical Results
Sample Description | Fresh | Aged | Geometric Mean Measured Concentration | ||||
(mg test item/L) | % of nominal1 | RSD (%) | n | % of nominal | RSD (%) | n | mg test item/L |
Control | n.a. | n.a. | 2 | n.a. | n.a. | 2 | n.a. |
0.9 | 86 | 11 | 2 | 13 | 1 | 2 | 0.119 |
2 | 80 | 18 | 2 | 19 | 0 | 2 | 0.237 |
4.3 | 81 | 16 | 2 | 29 | 4 | 2 | 2.1 |
9.3 | 74 | 17 | 2 | 45 | 2 | 2 | 5.36 |
20 | 75 | 9 | 2 | 57 | 3 | 2 | 13.1 |
1 Mean value of all measured samples per treatment group
italic: Values are partially < LOQ. For values <LOQ, half the LOQ was used for calculation of geometric mean measured concentrations
RSD: Relative standard deviation per treatment group
n: number of samples analysed
n.a.: not applicable
Yield, y, and Percentage inhibition of y during the Test Period
Geometric mean measured concentration | yields, y, (1000 cells/mL) and % inhibition of yield | |||||
0 - 24 hours | 0 - 48 hours | 0 - 72 hours | ||||
(mg test item/L) | y | % | y | % | y | % |
Control | 1.799 | - | 15.675 | - | 71.908 | - |
0.119 | 1.301 | 27.7 | 14.487 | 7.6 | 68.995 | 4.1 |
0.237 | 1.531 | 14.9 | 12.494 | 20.3 | 64.548 | 10.2* |
2.1 | 1.148 | 36.2* | 11.42 | 27.1 | 59.182 | 17.7* |
5.36 | 0.841 | 53.3* | 9.044 | 42.3* | 38.943 | 45.8* |
13.1 | 0.228 | 87.3* | 2.604 | 83.4* | 17.477 | 75.7* |
Negative values in % inhibition indicates an increase in growth relative to the control
* mean value signifcantly different from the control (tested with Bonferroni-Welch t-test (48 h) and Williams t-test (24 h and 72 h), α = 0.05, one-sided
Growth Rates and Percentage inhibition of growth rate during the Test Period
Geometric mean measured concentration | Growth rates, μ, (1/day) and % inhibition of μ | |||||
0 - 24 hours | 0 - 48 hours | 0 - 72 hours | ||||
(mg test item/L) | μ | % | μ | % | μ | % |
Control | 1.515 | - | 1.732 | - | 1.658 | - |
0.119 | 1.268 | 16.3 | 1.699 | 1.9 | 1.645 | 0.8 |
0.237 | 1.376 | 9.2 | 1.626 | 6.1* | 1.622 | 2.2 |
2.1 | 1.165 | 23.1* | 1.581 | 8.7* | 1.594 | 3.8* |
5.36 | 0.983 | 35.1* | 1.474 | 14.9* | 1.456 | 12.2* |
13.1 | 0.342 | 77.4* | 0.913 | 47.3* | 1.189 | 28.3* |
Negative values in % inhibition indicates an increase in growth relative to the control
* mean value signifcantly different from the control (tested with Williams t-test, α = 0.05, one-sided)
Description of key information
The 72-hour ErC50 and ErC10 values were calculated to be > 13.1 mg test item/L and 4.76 mg test item/L, respectively. The 72-hour EyC50 and EyC10 were calculated to be 6.36 mg test item/L and 1.60 mg test item/L, respectively.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 13.1 mg/L
- EC10 or NOEC for freshwater algae:
- 4.76 mg/L
Additional information
The toxicity of the test item to the green algae Pseudokirchneriella subcapitata was determined in an OECD 201 guideline test. Algae were exposed to nominal concentrations of 0.9, 2.0, 4.3, 9.3 and 20 mg test item/L, equivalent to geometric mean measured concentrations of 0.119, 0.237, 2.10, 5.36 and 13.1 mg test item/L alongside a control (2016). The study is a GLP compliant, guideline experimental study available as an unpublished report. There are no restrictions and it is fully adequate for assessment.
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