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EC number: 206-788-4 | CAS number: 375-50-8
- 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:
- From August 2017 to April 2018
- 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)
- Deviations:
- yes
- Remarks:
- without any impact on the overall integrity of the study or the interpretation of the study results and conclusions
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Appearance: Pink liquid
- Test item storage: At room temperature protected from light
- Purity/Composition correction factor: No correction factor required - Analytical monitoring:
- yes
- Details on sampling:
- Samples for possible analysis were taken from all test concentrations and the control according to the schedule below:
- frequency: at t = 0h, t = 24h and t = 72h;
- volume: 0.80 mL;
- storage: samples were transferred to the analytical laboratory at the Test Facility and analysed on the day of sampling.
At the end of the exposure, the replicates were not pooled at each concentrations before sampling. Instead, samples were taken from the same replicate at each test concentration.
Compliance with the Quality criteria regarding maintenance of actual concentrations was checked by running a test vessel at an intermediate item concentration but without algae and samples for analysis were taken at the start, after 24 hours of exposure and at the end of the test period. - Vehicle:
- no
- Details on test solutions:
- Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to ensure maximum dissolution of the test item in medium. The obtained mixture was allowed to settle for a period of one hour. Thereafter, the aqueous Saturated Solution (SS) was collected by means of siphoning and used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium. All test solutions were clear and colorless at the end of the preparation procedure.
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: NIVA CHL 1
- Source: In-house laboratory culture
- Stock culture : Algae stock cultures were started by inoculating growth medium (M1 medium formulated using Milli-RO water) 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
- Pre-culture: 4 days before the start of the test, cells from the algal stock culture (adjusted M2 medium formulated using Milli-RO water) were inoculated in culture medium at a cell density of 10000 cells/mL. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Hardness:
- 180 mg/L (expressed as CaCO3)
- Test temperature:
- 22 - 23°C
- pH:
- 7.4 - 7.9
- Nominal and measured concentrations:
- Nominal concentrations (final test): solutions containing 0 (control), 1, 3.2, 10, 32 and 100% of the Saturated Solution prepared at a loading rate of 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 40 mL, all-glass, airtight closed vessels with no headspace
- Renewal rate of test solution: none (static system)
- Initial cells density: 1 x 10000 cells/mL
- Control end cells density: 175.1 x 10000 cells/mL
- No. of vessels per concentration (replicates): 3 (+ 1 extra replicate for sampling purposes after 24 hours of exposure + 1 or 2 replicates of each test concentration without algae)
- No. of vessels per control (replicates): 6
- Incubation: Closed screw cap septum vessels were distributed at random in the incubator and daily repositioned. During incubation the algal cells were kept in suspension by continuous shaking
TEST MEDIUM / WATER PARAMETERS
- Medium: Adjusted M2 medium
OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: continous illumination
- Light intensity and quality: 85-87 μE.m-2.s-1
EFFECT PARAMETERS MEASURED
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). Algal medium was used as blank and the extra replicates, without algae, as background for the treated solutions. Cell densities were recorded at 24-hour intervals in the control and the limit concentration. Intermediate concentrations were measured only at the end of the exposure period
OTHER PARAMETERS MEASURED
- pH: at the beginning and at the end of the test in the control and the highest test concentration
- Temperature of medium: continuously in a temperature control vessel
- Appearance of the cells: at the end of the test, microscopic observations were performed on the control and the limit concentration to observe for any abnormal appearance of the algae.
TEST CONCENTRATIONS:
- Range finding test: yes (solutions containing 0 (control), 1, 10 and 100% of a Saturated Solution prepared at a loading rate of 100 mg/L)
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.39 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI 0.38-0.40 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.14 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI 0.13-0.14 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.15 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- yield
- Remarks on result:
- other: 95% CI 0.14-0.16 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.058 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- yield
- Remarks on result:
- other: 95% CI 0.047-0.067 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.054 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Remarks on result:
- other: based on biological relevance
- Results with reference substance (positive control):
- The 72h-ErC50 for growth rate inhibition by potassium dichromate was 0.86 mg/L with a 95% confidence interval ranging from 0.84 to 0.88 mg/L. The historical ranges for growth rate inhibition lie between 0.82 and 2.3 mg/L. The observed 72h-ErC50 for the algal culture tested corresponds with this range.
- Reported statistics and error estimates:
- Calculation of ECx values was based on concentrations up to 32% of the SS because no TWA concentration could be calculated for the highest test concentration. Probit analysis was conducted using linear max. likelihood regression with the percentages of growth rate inhibition and the percentages of yield inhibition versus the logarithms of the corresponding TWA concentrations of the test item.
- Test for normality of distribution; Shapiro-Wilk´s Test on Normal Distribution
Test for homogeneity of variance: Levene´s Test on Variance Homogeneity
Determination of NOEC: Williams Multiple Sequential t-test Procedure, α=0.05, one-sided, smaller
The calculations were performed with ToxRat Professional v. 3.2.1. (ToxRat Solutions® GmbH, Germany). - Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of test conditions, a dose-related increase of inhibition of growth rates was observed from a TWA concentration of 0.054 mg/L upwards. The EC10 for growth rate inhibition (72h-ERC10) was 0.14 mg/L with a 95% confidence interval ranging from 0.13 to 0.14 mg/L. The EC50 for growth rate inhibition (72h-ERC50) was 0.39 mg/L with a 95% confidence interval ranging from 0.38 to 0.40 mg/L. The 72h-NOEC for growth rate inhibition was 0.054 mg/L based on biological relevance and 0.026 mg/L based on statistical significance.
- Executive summary:
The toxicity of the test item to the freshwater green alga Pseudokirchneriella subcapitata was investigated in a GLP-compliant study performed in accordance with OECD Guideline No. 201. Under the conditions of the test, a dose-related increase of inhibition of growth rates was observed from a TWA concentration of 0.054 mg/L upwards. The EC50 for growth rate inhibition (72h-ErC50) was 0.39 mg/L (95% confidence interval ranging from 0.38 to 0.40 mg/L). The EC10 for growth rate inhibition (72h-ErC10) was 0.14 mg/L (95% confidence interval ranging from 0.13 to 0.14 mg/L). The 72h-NOEC for growth rate inhibition was 0.054 mg/L based on biological relevance and 0.026 mg/L based on statistical significance.
Reference
Measured Test Item Concentrations
At the start of the test, the actual test concentrations were 0.063, 0.13, 0.39 and 2.33 mg/L in solutions containing 1.0, 3.2, 10 and 32% of the SS (see below table). Unexpectedly, no detectable test item concentrations were found in the samples taken from the undiluted SS. This is most likely due to an error during the sample preparation or the instrumental analysis. At the end of the exposure period, the measured concentrations had decreased to 15-22% of the initial concentrations. The concentrations measured in the samples without algae were generally comparable to the corresponding results of samples with algae. Based on these results, the TWA concentrations were calculated to determine the effect parameters. No TWA concentration could be calculated for the highest test concentration.
Measured concentration (mg/L) t=0h |
Measured concentration (mg/L) t=24h |
Measured concentration (mg/L) t=72 h |
TWA (mg/L) |
|
1.0 |
0.0634 |
0.0307 |
0.00922 |
0.026 |
3.2 |
0.129 |
0.065 |
0.0186 |
0.054 |
10 |
0.394 |
0.262 |
0.0865 |
0.21 |
10 without algae |
0.674 |
0.283 |
0.204 |
0.31 |
32 |
2.33 |
1.14 |
0.292 |
0.93 |
100 |
n.d. |
4.62 |
0.520 |
n.a. |
Inhibition of Growth Rate
Growth rates were in the range of the control for the lowest test concentration during the 72-hour test period, whereas growth rates of algae exposed to TWA concentrations of 0.054
mg/L and higher were increasingly reduced (see below table). Statistically significant inhibition of growth rates was found at a TWA concentration of 0.054 mg/L and higher. However, the effects observed at TWA concentrations of 0.054 mg/L were considered not biologically relevant and, therefore, the NOEC based on biological relevance was set to 0.054 mg/L.
TWA concentration [mg/L] |
Mean Growth rate [day-1] |
Std. Dev. [day-1] |
n |
%Inhibition |
Control |
1.722 |
0.0118 |
6 |
|
0.026 |
1.717 |
0.0139 |
3 |
0.3 |
0.054 |
1.693 |
0.0282 |
3 |
1.7# |
0.21 |
1.336 |
0.0101 |
3 |
22.4* |
0.93 |
0.253 |
0.0216 |
3 |
85.3* |
n.d. (100% SS) |
0.346 |
0.0399 |
3 |
79.9* |
* - effect was statistically significant,
#- effect was statistically significant but biologically not relevant (<10%).
Inhibition of Yield
Inhibition of yield increased with increasing concentrations of the test item from a TWA concentration of 0.054 mg/L upwards, resulting in 99% inhibition at TWA concentrations of
0.93 mg/L and higher. Statistically significant inhibition of yield was found at TWA concentrations of 0.054 mg/L and higher. However, the effects observed at a TWA concentration of 0.054 mg/L were considered not biologically relevant and, therefore, the NOEC based on biological relevance was set to 0.054 mg/L
TWA concentration [mg/L] |
Mean Yield [day-1] |
Std. Dev. [day-1] |
n |
%Inhibition |
Control |
174.1 |
6.14 |
6 |
|
0.026 |
171.9 |
7.12 |
3 |
1.3 |
0.054 |
159.9 |
13.76 |
3 |
8.1# |
0.21 |
54.0 |
1.68 |
3 |
69.0* |
0.93 |
1.1 |
0.14 |
3 |
99.3* |
n.d. (100% SS) |
1.8 |
0.35 |
3 |
98.9* |
* - effect was statistically significant,
#- effect was statistically significant but biologically not relevant (<10%).
Acceptability of the Test
1. In the controls, cell density increased by an average factor of at least 16 within the exposure period (i.e. 175)
2. The mean coefficient of variation for section-by-section specific growth rates in the control cultures did not exceed 35% (i.e. 11%)
3. The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures did not exceed 7% (i.e. 0.7%)
Description of key information
The toxicity of the test item to the freshwater green alga Pseudokirchneriella subcapitata was investigated in a GLP-compliant study performed in accordance with OECD Guideline No. 201. Under the conditions of the test, a dose-related increase of inhibition of growth rates was observed from a TWA concentration of 0.054 mg/L upwards. The EC50 for growth rate inhibition (72h-ErC50) was 0.39 mg/L (95% confidence interval ranging from 0.38 to 0.40 mg/L). The EC10 for growth rate inhibition (72h-ErC10) was 0.14 mg/L (95% confidence interval ranging from 0.13 to 0.14 mg/L). The 72h-NOEC for growth rate inhibition was 0.054 mg/L based on biological relevance and 0.026 mg/L based on statistical significance.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 0.39 mg/L
- EC10 or NOEC for freshwater algae:
- 0.14 mg/L
Additional information
The toxicity of the test item to the freshwater green alga Pseudokirchneriella subcapitata was investigated in a GLP-compliant study performed in accordance with standard methods, with minor deviations. The study is considered as reliable (Klimisch 1) and is selected as a key study for the endpoint.
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