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EC number: 226-214-6 | CAS number: 5328-37-0
- 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:
- 2018-06-05 to 2018-06-08
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.5400 (Algal Toxicity, Tiers I and II) (January 2012)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: AD16081001
- Expiration date of the batch: 2019-08-09
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: Stable under ambient conditions - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: six replicate samples (2 mL per replicate) were taken from the test solution (100 mg/L) and from the control at the start and at the end of the test
- Sample storage conditions before analysis: No storage - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The test solution used in the test was prepared by mechanical dispersion without using of any solubilising agent. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- - Species: Raphidocelis subcapitata (formerly known as Pseudokirchneriella subcapitata and Selenastrum capricornutum)
- Strain Number: 61.81 SAG (identical strains: CCAP 278/4; UTEX 1648; ATCC 22662)
- Origin: The algae were supplied by the SAG: Collection of Algal Cultures, Inst. Plant Physiology, University of Göttingen, Untere Karspüle 2, D-37073 Göttingen, Germany
- Breeding Conditions: The stock cultures are small algal cultures that are regularly planted on agar. These are transferred to fresh medium at least once every two months under standardised conditions according to the test guidelines. The pre-culture is intended to give an amount of algae suitable for the inoculation of test cultures. The pre-culture was prepared with OECD Medium, incubated under the conditions of the test and used when still exponentially growing, normally after an incubation period of about three days. (The pre-culture was incubated for four days at this test.) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
- Hardness:
- Not specified
- Test temperature:
- In the test flasks: 22.6 – 23.1°C
In the climatic chamber: 22.1 - 23.9°C - pH:
- 7.72 – 9.01
- Dissolved oxygen:
- Not specified
- Salinity:
- Not applicable
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- Nominal: 100 mg/L
Mean measured: 35.62 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Material, size, fill volume: Glass, ~250 mL volume, 100 mL test medium
- Aeration: No
- No. of vessels per concentration: 6
- No. of vessels per control: 6
- Initial cell density: 10^4 cells/mL in each test flask
GROWTH MEDIUM
- Standard medium used: Yes, OECD Medium
TEST MEDIUM
- Preparation of dilution water: Reconstituted algal growth medium (OECD medium, according to OECD 201) was used as dilution water. Separate stock solutions were prepared in deionised water (prepared in TOXI-COOP ZRT. by MILLIPORE Direct-Q 5 water purification system). Then, the growth medium was prepared by adding an appropriate volume of these different stock solutions to deionised water in order to achieve the final concentrations.
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: Continuous illumination
- Light quality: Fluorescent lamps (400-700 nm)
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: At 24, 48 and 72 h manual cell counting using microscope with counting chamber
STATISTICAL ANALYSIS
Mean values and standard deviations were calculated at the start, and on each subsequent day of the test using Microsoft Excel for Windows software. Statistical comparisons of average specific growth rates and yield in control and in treated group were not necessary. The EC values of the test item and the NOEC and LOEC values related to growth rates and yield were determined directly from the raw data. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (K2Cr2O7)
- 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
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 35.62 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 35.62 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- 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.:
- > 35.62 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 35.62 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- 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:
- NOEC
- Effect conc.:
- 35.62 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 35.62 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- VALIDITY OF THE TEST
Cell density in the control cultures increased by a factor of more than 16 (by a factor of 169.83) within 72 hours. This corresponds to a specific growth rate of 1.71 day^-1.
The mean coefficient of variation (CV) for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72 h-tests) in the control cultures did not exceed 35 %.
- CV for section-by-section growth rate day 0-1: 6.40 %
- CV for section-by-section growth rate day 1-2: 8.91 %
- CV for section-by-section growth rate day 2-3: 4.56 %
The mean coefficient of variation for section-by-section specific growth rates: 6.63 %.
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures did not exceed 7 % in test.
- CV for average specific growth rate day 0-3: 3.41 %
All validity criteria were met, therefore the study is considered as valid. - Results with reference substance (positive control):
- 72h ErC50: 1.08 mg/L, (95 % confidence limits: 0.79 – 1.51 mg/L)
72h EyC50: 0.61 mg/L, (95 % confidence limits: 0.49 – 0.76 mg/L)
The date of the last study with the reference item Potassium dichromate was: 26 February - 01 March 2018. - Reported statistics and error estimates:
- As a limit test was performed the EC values of the test item and the NOEC and LOEC values related to growth rates and yield were determined directly from the raw data.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a Growth Inhibition Test according to OECD TG 201 the 72-h EC10 and EC50 (growth rate and yield) of the test item was determined to be > 100 mg/L (nominal).
- Executive summary:
The toxicity of the test item to the unicellular freshwater green alga Raphidocelis subcapitata was determined according to the principles of GLP, OECD 201, Council Regulation (EC) No. 761/2009 C.3 and EPA OPPTS 850.5400. A limit test was performed in which exponentially growing algal cells were exposed for 72 hours to aqueous test media (OECD Medium) containing the test item at the limit test concentration of 100 mg/L (6 replicates). In addition, a negative control and a positive control (with Potassium dichromate) with each 6 replicates was performed. Glass flasks with a total capacity of 250 mL were used as test vessels. The volume of the test liquid in the vessels was 100 mL. The algal cell concentration was determined by manual cell counting by microscope in each testing flask during the 72-hour test, in 24-hour intervals. The initial cell density was about 104cells/mL in each test flask. Concentrations of the test item were determined using a LC/MS/MS method. Geometric mean exposure concentration was determined as 35.62 mg/L. Thus, the analytically measured test item concentration was below 80 % of the nominal at the end of the test (13 %). However, due to the test item characteristic keeping the concentration within ± 20 % of the nominal was not possible (semi-static or flow through system is not applicable in alga test). Therefore, biological endpoints were based on the nominal test item concentration. The results showed that the 0-72 h average specific growth rate and yield at the treatment group (100 mg/L nominal concentration) was not significantly different from the untreated control (directly from the raw data). Statistical comparisons of average specific growth rates and yield in control and in treated group were not necessary. The EC10, EC20, EC50, NOEC and LOEC values were given directly from the raw data. Based on nominal test item concentration the 72 -h EC10, EC10, EC50 and the LOEC values were determined to be > 100 mg/L and >35.62 mg/L based on geom. mean measured concentration. The 72-h NOEC was determined to be 100 mg/L (nominal) and 35.62 mg/L (geom. mean measured), respectively. All validity criteria of the guidelines were met and therefore the study is considered as valid.
Reference
Table 1: Summary of biological endpoints
Endpoints |
Growth rate (r) |
Yield (y) |
EC10 |
> 100 mg/L |
> 100 mg/L |
EC20 |
> 100 mg/L |
> 100 mg/L |
EC50 |
> 100 mg/L |
> 100 mg/L |
NOEC |
100 mg/L |
100 mg/L |
LOEC |
> 100 mg/L |
> 100 mg/L |
Table 2: Algal cell number (x 104 cell/mL) during the test period of 72 hours and Yield
Test Group |
|
Number of Cells (× 104/mL) |
Yield |
|||
0 h |
24 h |
48 h |
72 h |
|||
Control |
|
1 |
4 |
28 |
168 |
167 |
|
1 |
4 |
33 |
203 |
202 |
|
|
1 |
5 |
27 |
161 |
160 |
|
|
1 |
4 |
26 |
128 |
127 |
|
|
1 |
4 |
27 |
156 |
155 |
|
|
1 |
4 |
35 |
203 |
202 |
|
Mean value |
1.00 |
4.17 |
29.33 |
169.83 |
168.8 |
|
SD |
0.0 |
0.4 |
3.7 |
29.1 |
29.1 |
|
100 mg/L(nominal) |
|
1 |
4 |
22 |
94 |
93 |
|
1 |
4 |
32 |
187 |
186 |
|
|
1 |
4 |
28 |
193 |
192 |
|
|
1 |
4 |
30 |
206 |
205 |
|
|
1 |
4 |
31 |
164 |
163 |
|
|
1 |
4 |
28 |
153 |
152 |
|
Mean value |
1.00 |
4.00 |
28.50 |
166.17 |
165.2 |
|
SD |
0.0 |
0.0 |
3.6 |
40.3 |
40.3 |
Table 3: The specific growth rates during the test period of 72 hours
Test Group |
|
Growth Rates (r) |
||
0 – 24 h |
0 – 48 h |
0 – 72 h |
||
Control |
|
0.0578 |
0.0694 |
0.0712 |
|
0.0578 |
0.0728 |
0.0738 |
|
|
0.0671 |
0.0687 |
0.0706 |
|
|
0.0578 |
0.0679 |
0.0674 |
|
|
0.0578 |
0.0687 |
0.0701 |
|
|
0.0578 |
0.0741 |
0.0738 |
|
Mean value |
0.0593 |
0.0703 |
0.0711 |
|
SD |
0.0038 |
0.0026 |
0.0024 |
|
100 mg/L(nominal) |
|
0.0578 |
0.0644 |
0.0631 |
|
0.0578 |
0.0722 |
0.0727 |
|
|
0.0578 |
0.0694 |
0.0731 |
|
|
0.0578 |
0.0709 |
0.0740 |
|
|
0.0578 |
0.0715 |
0.0708 |
|
|
0.0578 |
0.0694 |
0.0699 |
|
Mean value |
0.0578 |
0.0696 |
0.0706 |
|
SD |
0.0000 |
0.0028 |
0.0040 |
Table 4: Growth Rates (r) and percentage inhibition of r during the test period
Test Group |
Growth Rates (r)and % Inhibition ofr |
|||||
0–24 h |
0–48 h |
0–72 h |
||||
r |
% |
r |
% |
r |
% |
|
Control |
0.0593 |
- |
0.0703 |
- |
0.0711 |
- |
100 mg/L(nominal) |
0.0578 |
2.6 |
0.0696 |
0.9 |
0.0706 |
0.8 |
Table 5: Yield (y) and percentage inhibition of y during the test period
Test Group |
Yield (y) and % Inhibition of y |
|
0–72 h |
||
y |
% |
|
Control |
168.8 |
- |
100 mg/L(nominal) |
165.2 |
2.2 |
Table 6: The section-by-section specific growth rates in the control cultures
Section-by-Section Growth Rate |
|||
Expressed in hours |
0–24 h |
24-48 h |
48-72 h |
0.0593 |
0.0812 |
0.0729 |
|
Expressed in days |
0-1 day |
1-2 day |
2-3 day |
1.4235 |
1.9488 |
1.7500 |
Table 7: Concentration of Test Item measured in the Test Solutions
Nominal concentration (mg/L) | Start (June 05, 2018) | End (June 08, 2018) | ||
Concentration (mg/L) | % of the nominal concentration | Concentration (mg/L) | % of the nominal concentration | |
Control | not detected | - | not detected | - |
100 | 97.5 | 97 | 0* | - |
99.1 | 99 | 26.3 | 26 | |
97 | 97 | 15.3 | 15 | |
98.5 | 98 | 20.3 | 20 | |
97.8 | 98 | 0* | - | |
95.9 | 96 | 1.0* | - | |
Mean: | 97.6 | 98 | 13 | - |
RSD: | 1 | 1 | - | - |
* Below the LOQ.
LOQ = 10 mg/L, because sample was tenfold diluted.
For the calculation of the mean value LOQ/2 (5 mg/L) was entered.
Description of key information
In a Growth Inhibition Test according to OECD TG 201 the 72-h EC10 and EC50 (growth rate and yield) of the test item was determined to be > 100 mg/L (nominal).
Key value for chemical safety assessment
Additional information
Key study
The toxicity of the test item to the unicellular freshwater green alga Raphidocelis subcapitata was determined according to the principles of GLP, OECD 201, Council Regulation (EC) No. 761/2009 C.3 and EPA OPPTS 850.5400. A limit test was performed in which exponentially growing algal cells were exposed for 72 hours to aqueous test media (OECD Medium) containing the test item at the limit test concentration of 100 mg/L (6 replicates). In addition, a negative control and a positive control (with Potassium dichromate) with each 6 replicates was performed. The algal cell concentration was determined by manual cell counting by microscope in each testing flask during the 72-hour test, in 24-hour intervals. Concentrations of the test item were determined using a LC/MS/MS method. In result, the EC10, EC20, EC50, NOEC and LOEC values were given directly from the raw data. Based on nominal test item concentration the 72 -h EC10, EC10, EC50 and the LOEC values were determined to be > 100 mg/L and >35.62 mg/L based on geom. mean measured concentration. The 72-h NOEC was determined to be 100 mg/L (nominal) and 35.62 mg/L (geom. mean measured), respectively. All validity criteria of the guidelines were met and therefore the study is considered as valid (Toxi-Coop ZRT, 2018).
Supporting study
The short-term toxicity of the test item to green algae was calculated using ECOSAR v1.11 class-specific estimation for Aldehydes (Mono). The test item falls in the applicability domain of the model. In result, the 96-h LC50 was calculated to be 7572.364 mg/L.
Disclaimer: In accordance with Article 13 and taking into account the conditions set out in Annex XI of Regulation (EC) No 1907/2006, information on intrinsic properties of substances might be generated by alternative methods other than tests if the (Q)SAR model has been proven to be valid, the substance falls in the applicability domain of the model, results are sufficient for the classification and labeling and/or risk assessment and the applied method is reliably and adequately documented. These criteria are considered to be fulfilled and, hence, the result to be suitable for classification and labelling purposes and/or risk assessment (SCC GmbH, 2018).
Conclusion
Based on results of a GLP-compliant guideline study (Toxi-Coop ZRT, 2018) the 72-h EC10 and EC50 (growth rate and yield) is considered to be > 100 mg/L (nominal). This result is supported by an ECOSAR estimation (SCC GmbH, 2018) since the calculated 96-h EC50 of the test item was even higher (96-h LC50 = 7572.364 mg/L, ChV = 1142.977 mg/L).
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