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EC number: 206-169-9 | CAS number: 305-84-0
- 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:
- 28 Apr - 21 Jun 2017
- 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:
- 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health, Bern, Switzerland
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and 100 mg/L
- Sampling method: Samples without algae were taken at test start and stability samples with algae were taken, after 24 and 48 hours and at the end of the test (72 hours).
- Sample storage conditions before analysis: All samples were stored frozen (at -20 ± 5 °C) immediately after sampling until analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test item (50.16 mg) was solved in 500 mL test water using ultrasonic treatment for 15 minutes and intense stirring for 15 minutes at room temperature.
- Controls: yes, test medium control
- Evidence of undissolved material: After the dissolving procedure the single test concentration of 100 mg/L was a clear solution.
- Eluate: No - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Strain: 61.81 SAG
- Source: supplied by the Collection of Algal Cultures
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: Cultivated at test facility under standardized conditions according to the test guidelines.
ACCLIMATION
- Culturing media and conditions: same as test - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Hardness:
- 0.15 mmol/L (= 15 mg/L as CaCO3)
- Test temperature:
- maintained at 24 °C
- pH:
- 7.4 - 8.0 (Control and 100 mg/L)
- Nominal and measured concentrations:
- Control and 100 mg/L
- Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open (covered with a glass dish)
- Material, size, headspace, fill volume: 75 mL Erlenmeyer flasks, 30 mL test volume, 45 mL headspace
- Initial cells density: 0.64 x 10E+04 cells/mL
- Control end cells density: 140.1 x 10E+04 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
- Others: Test vessels were placed in a temperature controlled orbital shaker and were positioned randomly and repositioned daily.
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: AAP medium according to the OECD 201 guideline
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- pH: 7.5
- Photoperiod: continuously
- Light intensity and quality: LED light; approx 66 μE s-1 m-2 (range: 65 to 67 μE s-1 m-2)
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: The algal biomass was determined by fluorescence measurement. The measurements were performed at an excitation of 440 nm and emission of 680 nm. At the end of the test, a sample was taken from the control and from the single test concentration of 100 mg/L to determine a potential influence of the test item on the algal cells.
- Other: The shape and size of the algal cells were visually inspected.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable limit test
Range finding study
- Test concentrations: 0.1, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: Since no effects were observed up to and including 100 mg/L a limit test was performed. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): No
- Unusual cell shape: Microscopic examination of the algal cells at the end of the test showed no difference between the algae growing at the test concentration of 100 mg/L and the algal cells in the control. The shape and size of the algal cells were obviously not affected by the test item up to at least this test concentration. - Results with reference substance (positive control):
- The 72 h EC50 for growth rate in the reference test was 1.0 mg/L (May 2017) and showed that the sensitivity of the test system was within the range recommended by the guideline (72 h EC50 for the growth rate 0.9-1.5 mg/L).
- Reported statistics and error estimates:
- The 72 h EC10, EC20 and EC50 values of the test item could not be determined because of the absence of a significant inhibitory effect of the test item on the algal growth at the tested concentrations. For the determination of the LOEC and NOEC, the average growth rate and yield at the test concentrations were compared to the control values by the Two-sample t-test. Statistical analysis was performed using ToxRat Professional®.
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
- Conclusions:
- In conclusion, the test item had no toxic effects on Pseudokirchneriella subcapitata during the 72-hour test period up to and including the concentration of 100 mg/L.
Reference
Table 1: Biological Results Cell numbers
Nominal Test Item Concentration [mg/L] |
Repl. No. |
Biomass of Algae* |
||
|
|
24 Hours |
48 Hours |
72 Hours |
Control |
1 |
4.0 |
25.8 |
143.4 |
|
2 |
3.6 |
26.0 |
142.7 |
|
3 |
3.4 |
24.9 |
134.6 |
|
4 |
3.2 |
26.0 |
144.6 |
|
5 |
3.4 |
25.3 |
137.0 |
|
6 |
3.0 |
25.1 |
138.4 |
|
Mean |
3.4 |
25.5 |
140.1 |
|
SD |
0.4 |
0.5 |
4.0 |
100 |
1 |
4.4 |
29.2 |
146.6 |
|
2 |
3.5 |
26.7 |
140.0 |
|
3 |
4.3 |
30.4 |
150.1 |
|
4 |
3.3 |
28.7 |
146.9 |
|
5 |
3.0 |
26.4 |
143.3 |
|
6 |
3.1 |
25.4 |
138.3 |
|
Mean |
3.6 |
27.8 |
144.2 |
|
SD |
0.6 |
1.9 |
4.5 |
SD: Standard deviation
*: The biomass was determined by fluorescence measurement (mean of duplicate measurements per replicate) and is given as relative fluorescence units (x 10E+04). At the start of the test, the initial cell density was 5000 algal cells/mL, corresponding to 0.64 x 10E+04 relative fluorescence units.
Table 2: Biological results inhibition of growth rate
Nominal Test Item Concentration |
Average Growth Rate μ (day-1) and Inhibition of μ (Ir) |
|||||
|
0-24 h |
0-48 h |
0-72 h |
|||
[mg/L] |
μ |
Ir [%] |
μ |
Ir [%] |
μ |
Ir [%] |
Control |
1.677 |
0.0 |
1.846 |
0.0 |
1.798 |
0.0 |
100 |
1.715 |
-2.3 |
1.888 |
-2.3 |
1.808 |
-0.5 |
No statistically significant effect at the single test concentration compared to control (according to Two-Sample t-test, one-sided smaller, α= 0.05).
Table 3: Validity criteria for OECD 201
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72-hour test period. |
220 |
Yes |
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) in the control cultures must not exceed 35% |
11% |
Yes |
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 7% in tests with Pseudokirchneriella subcapitata and Desmodesmus subspicatus. For other less frequently tested species, the value should not exceed 10%. |
0.5% |
Yes |
Table 4: Analytical Results for Test Samples
Sampling Day/Sample Age |
Nominal Concentration of Test Item cnom |
Measured Concentration of Test Item x |
Sample Preparation Factor F |
Determined Concentration of Test Item c |
% of Nominal Concentration |
[d/h] |
[mg/L] |
[mg/L] |
|
[mg/L] |
[%] |
0/0 |
Control |
n.d. |
1 |
<LOQ |
n.a. |
(fresh) |
100 |
95.6 |
1 |
95.6 |
96 |
1/24 |
Control |
n.d. |
1 |
<LOQ |
n.a. |
(aged) |
100 |
95.5 |
1 |
95.5 |
95 |
2/48 |
Control |
n.d. |
1 |
<LOQ |
n.a. |
(aged) |
100 |
95.9 |
1 |
95.9 |
96 |
3/72 |
Control |
n.d. |
1 |
<LOQ |
n.a. |
(aged) |
100 |
96.9 |
1 |
96.9 |
97 |
n.d. = no test item detected
n.a. = not applicable
LOQ: 24.2 mg/L
The tabulated values of the samples represent rounded results obtained by calculation using the exact raw data.
Description of key information
ErC50 (72 h) >100 mg/L (Pseudokirchneriella subcapitata, OECD 201, nominal)
ErC10 (72 h) >100 mg/L (Pseudokirchneriella subcapitata, OECD 201, nominal)
Key value for chemical safety assessment
Additional information
One experimental study is available investigating the toxicity of the substance to aquatic freshwater algae. The study was conducted according to OECD 201 (GLP) using the freshwater algae Pseudokirchneriella subcapitata. Since no effects were observed in the range-finding test, a limit-test was performed testing control and 100 mg/L. The measured concentrations at test start and test end were within a range of 80 - 120% of nominal. No statistically significant differences on growth rate and yield were determined compared to the control. Thus, the EC50 and EC10 after 72 h were derived to be >100 mg/L.
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