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EC number: 223-765-4 | CAS number: 4058-30-4
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 2016-11-14 to 2017-03-03, with the definitive exposure phase from 2017-02-28 to 2017-03-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Principles of method if other than guideline:
- The method was modified according to OECD series no. 23. The test substance solution was orange. Since this may affect the light intensities for the algae cultures the volumes of test media in the test vessels was lowered in order to minimize the water layer and the path length.
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test substance:
The test concentration was analytically verified via HPLC-DAD in the saturated solution, the dilutions and the control at the start of the exposure (0 h) and at the end of the exposure (72 h).
Sampling for the analytical monitoring:
At the start of the exposure (0 h), sampling was carried out after preparation of the loading levels. Samples of the aged media were taken from the test vessels (with algae) at the end of the exposure (72 h). - Vehicle:
- no
- Details on test solutions:
- Preparation of the Saturated solution:
A saturated solution with a nominal loading of 100 mg test item/L was prepared once 24 ± 1 hour prior to the start of the exposure. An appropriate amount of the test substance was weighed out. The test item was applied onto a glass slide. The glass slide with the test substance was inserted into a glass bottle with an appropriate amount of demineralized water. The saturated solution was stirred for 24 hours (1100 rpm) with a magnetic stirrer. Undissolved particles were removed by membrane filtration (membrane filter 0.45 µm, RC, MACHEREY-NAGEL). The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate will be discarded. The filtration was interrupted for 10 minutes to allow adsorption and saturation of the filter material with dissolved test substance. Thereafter, the filtration was continued. The next 25 mL were discarded. During filtration, the filter will always be kept covered.
The solution was checked via laser beam (Tyndall effect), which was positive. Then the components of the dilution water were added to the saturated solution.
Test loading:
All terms related to concentration level are given as loading level because partly dissolved compounds and mixtures cannot be related to concentrations. The saturated solution and four dilution levels out of the saturated solution were tested in a geometrical series with a dilution factor of 2: 6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution.
Control:
Six replicates (without test substance) were incubated under the same conditions as the test loadings. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata HINDÁK
- Strain: SAG 61.81
- Source (laboratory, culture collection): SAG, Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, D-37073 Göttingen
- Age of inoculum (at test initiation): 4 days
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 2567 – 5130 lux corresponding to 35 - 70 µE ∙ m-2 ∙ s-1 for 24 h per day. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
- Hardness:
- Not specified
- Test temperature:
- min: 22°C max: 22.5°C mean value: 22.3°C
- pH:
- Nominal test substance loading pH-values
[% of the saturated solution] Start; 0 h End; 72 h
100 7.57 7.45
50.0 7.61 7.50
25.0 7.69 7.56
12.5 7.78 7.67
6.25 7.89 7.91
Control 8.03 8.27 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- Nominal and measured concentrations:
- Nominal: 6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution
Measured: < LOQ - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Type (delete if not applicable): open, cotton wool plugs
- Material, size, headspace, fill volume: sterile 250 mL Erlenmeyer flasks, test volume 25 mL
- Aeration: Test containers were placed on a rotary shaker and oscillated at appr. 70 rpm
- Type of flow-through (e.g. peristaltic or proportional diluter): None
- Renewal rate of test solution (frequency/flow rate): One application at test start
- Initial cells density: Nominal: approximately 2 - 5 x 10E+3 cells/mL, Actual: mean 6839 cells/mL
- Control end cells density: Mean 1619065 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Composition of Dilution Water
according to the guideline
Component Concentration [mg/L]
NH4Cl 15
MgCl2 x 6 H2O 12
CaCl2 x 2 H2O 18
MgSO4 x 7 H2O 15
KH2PO4 1.6
FeCl3 x 6 H2O 0.064
Na2EDTA x 2 H2O 0.1
H3BO3 0.185
MnCl2 x 4 H2O 0.415
ZnCl2 3 x 10^-3
Na2MoO4 x 2 H2O 7 x 10^-3
CoCl2 x 6 H2O 1.5 x 10^-3
CuCl2 x 2 H2O 1 x 10^-5
NaHCO3 50
pH 8.1 ± 0.2
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 h
- Light intensity and quality: approximately 4440 to 8880 lux, corresponding to 60 to 120 µE ∙ m-2 ∙ s-1, mean value: 5684 lux,
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
-Chlorophyll a-fluorescence
The cell density was measured daily via Chlorophyll a-fluorescence, excitation at 436 nm, emission at 685 nm. Dilution water was used as a background signal. Self-fluorescence was observed in the range finding test. A separate replicate for the loading levels were prepared without algae and treated the same as the other test replicates. The self-fluorescence of each measuring point was taken into account in the evaluation. - Reference substance (positive control):
- yes
- Remarks:
- (Potassium dichromate)
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL10
- 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:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 71.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: CI: 51.1 - 96.9
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- 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):
- Unusual cell shape: No
- Colour differences: No
- Flocculation: No
- Adherence to test vessels: No
- Aggregation of algal cells: No
- Other: The test item concentrations were clear during the exposure. The algae in the saturated solution were agglutinated after 72 hours. No agglutination of the algae was observed in the control replicates.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- The toxicity of potassium dichromate (SIGMA, batch number MKBV0900V, purity 99.0 %, CAS RN 7778-50-9) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined over a period of 72 hours from 2016-10-11 to 2016-10-14 (with headspace). The reference item toxicity is in the valid range following test facility SOPS.
EC50-Values of the Reference Item
based on nominal concentrations mg/L, (0-72 hours)
Current Study Valid Range (average ± 3 x SD)
Growth Rate inhibition
ErC50 0.435 0.764 ± 0.513
95 % confidence interval 0.414 – 0.458
Yield inhibition
EyC50 0.230 0.402 ± 0.293
95 % confidence interval 0.179 – 0.322
SD = Standard deviation - Reported statistics and error estimates:
- EL-values and statistical analyses
EL-values of growth rate and yield inhibition after 72 hours were calculated by sigmoidal dose-response regression.
NOEL, LOEL and analyses
The NOEL and LOEL were determined by calculation of statistically significant differences of growth rates and yield. As a standard, One Way Analysis of Variance (ANOVA) and DUNNETT’s test were used for NOEL/LOEL calculations. When running a One Way Analysis of Variance, a Normality test and an Equal Variance test were done first. P-values for both Normality and Equal Variance tests are 0.05. The -value (acceptable probability of incorrectly concluding that there is a difference) is =0.05.
Software
The data for the tables in this report were computer-generated and have been rounded for presentation from the full derived data. Consequently, if calculated manually based on the given data minor deviations may occur from these figures.
Calculations were carried out using software
- Excel, MICROSOFT CORPORATION
- SigmaPlot, SPSS INC.
- GraphPad Prism, GRAPHPAD SOFTWARE, INC. - Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions, the test substance was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 h with the following effect values (based on nominal loading levels): EL50 values with 95% confidence intervals for both inhibition of growth rate (ErL50) and yield (EyL50) after 72 h were > 100%, respectively.
- Executive summary:
The toxicity of the test substance to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the OECD Guideline 201 and EU Method C.3. The study was conducted under static conditions with an initial cell density of 6839 cells/mL. A saturated solution with a nominal loading of 100 mg test substance/L was prepared with demineralized water 24±1 h prior to the start of the exposure. An appropriate amount of the test substance was weighed out. The saturated solution was stirred for 24 ±1 h (1100 rpm) with a magnetic stirrer. Undissolved particles were removed by membrane filtration. The following filtrate, i.e. the saturated solution was used in the test. The solution was checked via laser beam (Tyndall effect), which was positive. Thereafter the components of the dilution water were added to the saturated solution. The saturated solution and four dilution levels out of the saturated solution were tested in the definitive test in a geometrical series with a dilution factor of 2:6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution. Three replicates were tested for each concentration and six replicates for the control. The test media were clear throughout the test period. The environmental conditions were within the acceptable limits. The concentration of the test substance was analytically verified via HPLC‑DAD at the start of the exposure of the saturated solution, the dilutions and the control. The recovery rates of the test substance at test start were below the lowest calibration level (LCL). Therefore, all effect values given are based on the nominal test substance loading levels. Under the study conditions, the test substance was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 h. However, the % inhibition of growth rate at the highest loading level was only 6% (not significant) and % inhibition of yield was 28%. The following effect values (based on nominal loading levels) were determined based on the results: The 72 h EL50 with 95% confidence intervals for both inhibition of growth rate (ErL50) and yield (EyL50) after 72 h were > 100% (i.e. 100 mg/L) respectively (Volker, 2017).
Reference
Cell Densities
Nominal test item loading |
Replicate |
Cell density [cells/mL] |
|||||||||
[% of the saturated solution] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
||||||
100 |
1 |
6839 |
18997 |
124160 |
1275845 |
||||||
2 |
6839 |
17694 |
118694 |
1194005 |
|||||||
3 |
6839 |
15939 |
105047 |
1009960 |
|||||||
Mean |
6839 |
17543 |
115967 |
1159937 |
|||||||
50.0 |
1 |
6839 |
23116 |
177682 |
1701315 |
||||||
2 |
6839 |
24181 |
178045 |
1740933 |
|||||||
3 |
6839 |
21686 |
166716 |
1575672 |
|||||||
Mean |
6839 |
22994 |
174148 |
1672640 |
|||||||
25.0 |
1 |
6839 |
26314 |
200072 |
1983674 |
||||||
2 |
6839 |
24006 |
184664 |
1926675 |
|||||||
3 |
6839 |
19991 |
146959 |
1537108 |
|||||||
Mean |
6839 |
23437 |
177232 |
1815819 |
|||||||
12.5 |
1 |
6839 |
32304 |
237478 |
1834565 |
||||||
2 |
6839 |
24214 |
180292 |
1877870 |
|||||||
3 |
6839 |
22710 |
173510 |
1767560 |
|||||||
Mean |
6839 |
26409 |
197093 |
1826665 |
|||||||
6.25 |
1 |
6839 |
28330 |
181211 |
1871081 |
||||||
2 |
6839 |
26209 |
200856 |
2021595 |
|||||||
3 |
6839 |
21893 |
164480 |
1655494 |
|||||||
Mean |
6839 |
25477 |
182182 |
1849390 |
|||||||
Control |
1 |
6839 |
26502 |
153724 |
1319882 |
||||||
2 |
6839 |
23649 |
177413 |
1796293 |
|||||||
3 |
6839 |
28260 |
181211 |
1564846 |
|||||||
4 |
6839 |
22979 |
101758 |
1538512 |
|||||||
5 |
6839 |
25413 |
162227 |
1746785 |
|||||||
6 |
6839 |
22789 |
185998 |
1748072 |
|||||||
Mean |
6839 |
24932 |
160389 |
1619065 |
Evaluation after 72 hours
Statistically
significant differences of growth rates and yield compared to
control
values are marked (+), not significant differences are marked (-).
Nominal test item loading |
Replicate |
Growth rate |
Inhibition of growth rate |
Yield |
Inhibition of yield |
||
[% of the saturated solution] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
100 |
1 |
|
1.74 |
4 |
|
1269006 |
21 |
2 |
|
1.72 |
5 |
|
1187166 |
26 |
|
3 |
|
1.67 |
9 |
|
1003121 |
38 |
|
Mean |
(+) |
1.71 |
6 |
(+) |
1153098 |
28 |
|
50.0 |
1 |
|
1.84 |
-1 |
|
1694476 |
-5 |
2 |
|
1.85 |
-1 |
|
1734094 |
-8 |
|
3 |
|
1.81 |
0 |
|
1568833 |
3 |
|
Mean |
(-) |
1.83 |
-1 |
(-) |
1665801 |
-3 |
|
25.0 |
1 |
|
1.89 |
-4 |
|
1976835 |
-23 |
2 |
|
1.88 |
-3 |
|
1919836 |
-19 |
|
3 |
|
1.81 |
1 |
|
1530269 |
5 |
|
Mean |
(-) |
1.86 |
-2 |
(-) |
1808980 |
-12 |
|
12.5 |
1 |
|
1.86 |
-2 |
|
1827726 |
-13 |
2 |
|
1.87 |
-3 |
|
1871031 |
-16 |
|
3 |
|
1.85 |
-2 |
|
1760721 |
-9 |
|
Mean |
(-) |
1.86 |
-2 |
(-) |
1819826 |
-13 |
|
6.25 |
1 |
|
1.87 |
-3 |
|
1864242 |
-16 |
2 |
|
1.90 |
-4 |
|
2014756 |
-25 |
|
3 |
|
1.83 |
-1 |
|
1648655 |
-2 |
|
Mean |
(-) |
1.87 |
-2 |
(-) |
1842551 |
-14 |
|
Control |
1 |
|
1.75 |
|
|
1313043 |
|
2 |
|
1.86 |
|
|
1789454 |
|
|
3 |
|
1.81 |
|
|
1558007 |
|
|
4 |
|
1.81 |
|
|
1531673 |
|
|
5 |
|
1.85 |
|
|
1739946 |
|
|
6 |
|
1.85 |
|
|
1741233 |
|
|
Mean |
|
1.82 |
|
|
1612226 |
|
Section-by-Section and
Average Specific Growth Ratesof the Control Group
(0 - 72 hours)
|
Replicate No. |
Specific growth rate [d-1] |
Mean (0 - 72 hours) |
SD ± |
CV |
Mean CV [%] |
||
section-by-section |
||||||||
0 - 24 hours |
24 - 48 hours |
48 - 72 hours |
||||||
Control |
1 |
1.35 |
1.76 |
2.15 |
1.75 |
0.398 |
22.7 |
29.4 |
2 |
1.24 |
2.02 |
2.32 |
1.86 |
0.554 |
29.9 |
||
3 |
1.42 |
1.86 |
2.16 |
1.81 |
0.371 |
20.5 |
||
4 |
1.21 |
1.49 |
2.72 |
1.81 |
0.801 |
44.3 |
||
5 |
1.31 |
1.85 |
2.38 |
1.85 |
0.532 |
28.8 |
||
6 |
1.20 |
2.10 |
2.24 |
1.85 |
0.562 |
30.4 |
||
|
|
|
Mean |
1.82 |
|
|
||
|
|
|
SD ± |
0.04 |
|
|||
|
|
|
CV [%] |
2.13 |
|
SD = Standard deviation CV = Coefficient of variation
Description of key information
ErL50 > 100 mg/l
Key value for chemical safety assessment
Additional information
No information on "toxicity to aquatic algae and cyanobacteria" is available on the Target Substance. However data available on Similar Substance 01 has been taken into account for the assessment. More details about the similarity between the two substances are reported in section 13.
The toxicity of the test substance to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the OECD Guideline 201 and EU Method C.3. The study was conducted under static conditions with an initial cell density of 6839 cells/mL. A saturated solution with a nominal loading of 100 mg test substance/L was prepared with demineralized water 24 ± 1 h prior to the start of the exposure. An appropriate amount of the test substance was weighed out. The saturated solution was stirred for 24 ± 1 h (1100 rpm) with a magnetic stirrer. Undissolved particles were removed by membrane filtration. The following filtrate, i.e. the saturated solution was used in the test. The solution was checked via laser beam (Tyndall effect), which was positive. Thereafter the components of the dilution water were added to the saturated solution. The saturated solution and four dilution levels out of the saturated solution were tested in the definitive test in a geometrical series with a dilution factor of 2:6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution. Three replicates were tested for each concentration and six replicates for the control.The test media were clear throughout the test period.The environmental conditions were within the acceptable limits.The concentration of the test substance was analytically verified via HPLC‑DAD at the start of the exposure of the saturated solution, the dilutions and the control. The recovery rates of the test substance at test start were below the lowest calibration level (LCL). Therefore, all effect values given are based on the nominal test substance loading levels. Under the study conditions,the test substance was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 h. However, the % inhibition of growth rate at the highest loading level was only 6% (not significant) and % inhibition of yield was 28%. The following effect values (based on nominal loading levels) were determined based on the results: The 72 h EL50 with 95% confidence intervals for both inhibition of growth rate (ErL50) and yield (EyL50) after 72 h were > 100% (i.e. 100 mg/L) respectively (Volker, 2017).
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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