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EC number: 202-424-3 | CAS number: 95-49-8
- 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:
- 2000-11-22 to 2001-05-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Remarks:
- High Performance Liquid Chromatography (HPLC)
- Details on sampling:
- At the start of exposure (0 hr), 2.0 mL of the test solution was collected from each of the three test vessels in each test group and mixed, and the sample was used as an analysis sample. At the end (72 hr), 2.0 mL of the test solution was collected from each of the three test vessels in each test group and mixed, and the supernatant after centrifugation (3000 rpm, 10 minutes) of the algae was used as the analysis sample. An equal amount of acetonitrile was added to 0.75 mL of each analysis sample, mixed, and then analyzed by HPLC. The test substance concentration of each test solution was quantified from the ratio with the peak area of the standard solution.
- Vehicle:
- yes
- Remarks:
- 0.01% (w/w): mixture of 2-methoxyethanol and HCO-60 in a ratio of 1 : 3 (w/w),
- Details on test solutions:
- 92 μL of the test substance, which is equivalent to 100 mg, was collected, dissolved in 100 mg of 2-methoxyethanol, and then 300 mg of HCO-40 was added and mixed. This was diluted with a medium and the volume was adjusted to 100 mL to prepare a test substance solution having a test substance concentration of 1000 mg/L. At the same time, a solvent agent solution of 4000 mg/L (2-methoxyethanol 1000 mg/L, HCO-40 3000 mg/L) containing no test substance was prepared.
Based on these solutions, est item concentration groups were prepared to contain a constant vehicle concentration of 0.01 % by weight.
The control group used only the medium, and the solvent agent control group contained only the solvent agent (solvent agent concentration: 100 mg/L). The state (appearance) of the test solution at the time of preparation was colourless and transparent in all test groups. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Test species:
1) Japanese name: Muremikazukimo (unicellular green algae)
2) Scientific name: Selenastrum capricornutum
3) Source: American Type Culture Collection
4) Obtained strain number: ATCC22662 Stock
5) Date of acquisition: June 20, 1996
6) Management after acquisition Aseptic subculture using Gorham medium
7) Sensitivity: 72 hours 50% algae growth inhibition concentration (EbC50) = 0.485 mg/L
with reference substance (potassium dichromate, technical grade reagent)
(This value is in the range of EbC50 value 0.285 to 0.529 mg/L, n = 7 since November 1996)
8) Pre-culture period: March 23, 2001-March 26, 2001; During this time, the algae grew logarithmically.
(Environmental conditions are the same as the test) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- 0.181 mM (Ca/Mg) according to OECD medium
- Test temperature:
- 22.4 - 23.8 °C
- pH:
- t=0: pH7.9
t= 72 h:
Controls and all but the two highest concentrations pH 10.5;
11.6 mg/L: pH 10.2;
25 mg/L: pH 8.2 - Dissolved oxygen:
- n.a.
- Salinity:
- n.a.
- Conductivity:
- No data
- Nominal and measured concentrations:
- Nominal test item concentration: 0.250, 0.540, 1.16, 2.50, 5.39, 11.6, 25.0 mg/L (common ratio: about 2.2)
Geometric mean measured test item concentrations:
0.124, 0.259, 0.574, 1.209, 2.613, 5.665, 12.552 mg/L - Details on test conditions:
- I. Test conditions
1) Exposure method : Static, shaking intensity (100 rpm)
2) Exposure period : 72 hours
3) Test water volume : 100 mL (OECD medium)/vessel
4) Number of replicates : 3 test vessels/experimental design
5) Initial cell density : 1x10^4 cells/mL
6) Test water temperature : 23 +/- 2 °C
7) Lighting : Continuous lighting at 4000 lux
(within ± 20% fluctuation, near flask liquid level)
II. Dilution water
The medium specified in the OECD Chemical Test Guideline (OECD medium) was used for both preculture and testing.
III. Test container and algae culture test equipment, etc.
1) Test container : 500 mL Erlenmeyer flask with stopper
2) Algae culture test device : Ito Seisakusho AGP-150RL type
3) Optical microscope : Nikon ECLIPSE TE300 type
4) Particle counting device : Sysmex CDA-500
5) Electrolyte solution for particle counting device: Sysmex Xel-Há
6) pH meter : Desktop pH meter manufactured by Toa Denpa Kogyo HM-40V type No. 2
7) Thermometer: Tasco Japan TNA-120 type
8) Illuminometer: Topcon IM-2D type
IV. Test concentration design
Based on the results of the preliminary test (1 test vessel each) shown in the table below, the test concentration for the main test was determined as follows.
Test groups (three replicates, each):
control group, solvent control group, 0.250, 0.540, 1.16, 2.50, 5.39, 11.6, 25.0 mg/L (common ratio: about 2.2)
V. Observations and measurements
The cell concentration was measured by collecting 1.0 mL of the test solution from each test container, mixing it with 9.0 mL of the electrolytic solution for the particle counting device (cell pack), and then measuring it with the particle counting device (CDA-500). For the algae in the test solution, the colour tone was observed with the naked eye 0.24 and 48 hours after the start of exposure, and the colour tone was observed, and the cell morphology was observed under a microscope at the end of the exposure. The pH of the test solution in each test group was measured for one single vessel prepared separately from the three vessels in each test group at the start of exposure, and for one of the three vessels (No. 1) at the end of exposure (72 hr). During the exposure period, the temperature and illuminance in the incubator were measured at least once a day.
VI. Evaluations
Yield based inhibition was calculated as follows:
Growth inhibition (IA) by comparison of areas under the growth curve (Area-based method):
Area (A) calculation: A = [(N_1 - N_0)/2]*t_1 + [(N_1 + N_2 - 2*N_0)/2]*(t_2 - t_1) + ... + [(N_n-1 + N_n - 2*N_0)/2]*(t_n - t_n-1)
where N_0: Nominal cell concentration at the initiation of exposure (cells/mL)
N_i: Measured cell concentration at t_i (cells/mL)
N_n: Measured cell concentration at to (cells/mL)
t_1: Time of first measurement of cell concentration after initiation of exposure
t_n: Time of nth measurement of cell concentration after initiation of exposure
Calculation of inhibition based on area under the growth curve [%]:
I_A = [(A_c - A_t)/A_c]*100
where A_c: Area under the growth curve for solvent control; A_t: Area under the growth curve for the treatment group.
Growth rate based inhibition: Calculated according to paragraphs 48 through 51 of OECD TG 201 (2006). - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate, special grade reagent
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 6.09 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 5.92 - 6.26
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 9.11 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 8.71 - 9.52
- Duration:
- 72 h
- Dose descriptor:
- EC5
- Effect conc.:
- 5.43 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 5.28 - 5.59
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 4.97 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 4.84 - 5.12
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8.44 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 8.14 - 8.75
- Details on results:
- All results given above are from the statistical re-evaluation performed in 2021. The original evaluation was performed based on initially measured values, and for the regulatory relevant endpoint growth rate for the exposure range between 24 and 72 h (instead of 0 - 72 h). Further, details on dose-response modelling were insufficient, and no confidence intervals were given.
Because the solvent control did not fulfil validity criteria according to OECD TG 201 (2006) for the last exposure interval (growth was not fully logarithmic any more between 48 and 72 h, see below for details), EC50 and EC10 were also derived for the interval 0-48 hours. Corresponding results demonstrate that there is no relevant underestimation of toxicity based on the effect values calculated for 0-72 hours.
For the endpoint reproduction rate, also NOECs were newly derived:
Exposure interval 0-72 h (normality test passed, variance homogeneity test passed, linear trend confirmed):
NOEC (0-72 h; growth rate) = 0.574 mg/L (Willilams test, a= 0.05)
LOEC (0-72 h; growth rate) = 1.279 mg/L (corresp. to 4.6% inhibition).
Exposure interval 0-48 h (normality test passed, variance homogeneity test failed)
NOEC (0-48 h; growth rate) = 2.61 mg/L (multiple sequentially-rejective Welsh t-test after Bonferroni-Holm, a= 0.05)
LOEC (0-48 h; growth rate) = 5.66 mg/L (corresp. to 20% inhibition).
Compared to the interval 0-72 h a significantly higher NOEC is obtained for the interval 0-48 h. This is mostly due to the fact that due to the variance heterogeneity a less powerful statistical test had to be performed.
Inhibition base on yield was not reevaluated. Originally reported values determined according to the area based method (based on measured initial concentrations) are the following:
EbC50 (0-72 h; yield) = 9.19 mg/L (no confidence interval)
NOEC (0-72 h; yield) = 3.69 mg/L - Results with reference substance (positive control):
- The 72-hour growth inhibition concentration (EbC50) of the reference substance (potassium dichromate, special grade reagent) was 0.485 mg/L.
- Reported statistics and error estimates:
- Statistical evaluation was performed relative to the solvent control and based on geometric mean measured concentrations. ToxRatStd© v3.3.0 was used for all evaluations. Further details are given in the attached illustration.
- Validity criteria fulfilled:
- yes
- Remarks:
- Please refer also to section "overall remarks"
- Conclusions:
- In the reliable and adequate key study (MOE Japan, 2001) on fresh water green alga growth inhibition performed compliant with GLP according to OECD TG 201 (1984), the following results were obtained (based on geometric mean measured concentrations; in relation to solvent control):
ErC05 (0-72h) : 5.43 mg/L (95% confidence limit: 5.28 - 5.59)
ErC10 (0-72h) : 6.09 mg/L (95% confidence limit: 5.92 - 6.26)
ErC50 (0-72h) : 9.11 mg/L (95% confidence limit: 8.71 - 9.52)
NOEC (0-72 h; growth rate) = 0.574 mg/L (Willilams test, a= 0.05)
LOEC (0-72 h; growth rate) = 1.279 mg/L (corresp. to 4.6% inhibition). - Executive summary:
The reliable and adequate key study (MOE Japan, 2001) on fresh water green alga growth inhibition was performed compliant with GLP according to OECD TG 201 (1984). Selenastrum capricornutum was tested under static exposure conditions for 72 hours exposure. A control, solvent control and 7 nominal test item concentrations (0.250, 0.540, 1.16, 2.50, 5.39, 11.6, 25.0 mg/L) were set up with 3 replicates, each. All test item concentrations were analytically verified at the beginning and the end (72 h) of the test. Measured concentrations were between 65% and 74% of nominal after 0h and between 33 and 36% of nominal after 72 h. Water parameters were measured at the start and end of the test, temperature and illuminance in the incubator were measured at least once a day and found to be within requirements of the guideline. The pH varied from 7.9 at the start of exposure and 10.2 - 10.5 except for the highest test item concentration (8.2 - associated with very poor growth). Due to measured values below 80% of nominal, (no)effect values were derived based on geometric mean measured concentrations.
The following results were obtained with regard to the endpoint growth rate:ErC05 (0-72h) : 5.43 mg/L (95% confidence limit: 5.28 - 5.59)
ErC10 (0-72h) : 6.09 mg/L (95% confidence limit: 5.92 - 6.26)
ErC50 (0-72h) : 9.11 mg/L (95% confidence limit: 8.71 - 9.52)
NOEC (0-72 h; growth rate) = 0.574 mg/L (Willilams test, a= 0.05)
LOEC (0-72 h; growth rate) = 1.279 mg/L (corresp. to 4.6% inhibition).
Reference
Nominal and measured concentrations:
Nominal | Measured Concentration (mg/L) | ||
Concentration (mg/L) | 0 Hour | 72 Hours | Geometric mean measured |
Control | <0. 003 | <0. 003 | |
Solvent control | <0. 003 | <0. 003 | |
0.250 | 0.170 | 0.091 | 0.124 |
0.540 | 0.349 | 0.192 | 0.259 |
1.160 | 0.799 | 0.412 | 0.574 |
2.500 | 1.640 | 0.891 | 1.209 |
5.390 | 3.690 | 1.850 | 2.613 |
11.600 | 8.270 | 3.880 | 5.665 |
25.000 | 18.600 | 8.470 | 12.552 |
Detailed data on single replicate growth:
Nominal concentration (mg/L) | Vessel | Cell Densities (cells/mL) | |||
0 | 24 | 48 | 72 | ||
1 | 10000 | 54900 | 247600 | 573800 | |
Control | 2 | 10000 | 50200 | 208600 | 466800 |
3 | 10000 | 46700 | 214600 | 516800 | |
Average | 10000 | 50600 | 223600 | 519100 | |
SD | 0 | 4100 | 21000 | 53500 | |
1 | 10000 | 67100 | 301600 | 644800 | |
Solvent. conc. | 2 | 10000 | 68600 | 324600 | 585800 |
3 | 10000 | 65200 | 322600 | 592800 | |
Average | 10000 | 67000 | 316300 | 607800 | |
SD | 0 | 1700 | 12700 | 32200 | |
1 | 10000 | 63400 | 278600 | 517800 | |
0.250 | 2 | 10000 | 63200 | 288600 | 597800 |
3 | 10000 | 44300 | 183600 | 400800 | |
Average | 10000 | 57000 | 250300 | 505500 | |
SD | 0 | 11000 | 58000 | 99100 | |
1 | 10000 | 67800 | 327600 | 594800 | |
0.540 | 2 | 10000 | 63300 | 307600 | 551800 |
3 | 10000 | 48500 | 198600 | 436800 | |
Average | 10000 | 59900 | 277900 | 527866 | |
SD | 0 | 10100 | 69400 | 81700 | |
1 | 10000 | 65100 | 313600 | 570800 | |
1.160 | 2 | 10000 | 54800 | 241600 | 486800 |
3 | 10000 | 60700 | 295600 | 535800 | |
Average | 10000 | 60200 | 283600 | 531100 | |
SD | 0 | 5200 | 37500 | 42200 | |
1 | 10000 | 54400 | 220600 | 451800 | |
2.500 | 2 | 10000 | 66000 | 307600 | 537800 |
3 | 10000 | 63800 | 298600 | 524800 | |
Average | 10000 | 61400 | 275600 | 504800 | |
SD | 0 | 6200 | 47800 | 46400 | |
1 | 10000 | 57500 | 270600 | 518800 | |
5.390 | 2 | 10000 | 56200 | 262600 | 505800 |
3 | 10000 | 53900 | 261600 | 489800 | |
Average | 10000 | 55900 | 264900 | 504800 | |
SD | 0 | 1800 | 4900 | 14500 | |
1 | 10000 | 41400 | 158600 | 410800 | |
11.600 | 2 | 10000 | 42100 | 156600 | 403800 |
3 | 10000 | 42900 | 159600 | 402800 | |
Average | 10000 | 42100 | 158300 | 405800 | |
SD | 0 | 800 | 1500 | 4400 | |
1 | 10000 | 15800 | 17800 | 20200 | |
25.000 | 2 | 10000 | 15200 | 17400 | 18000 |
3 | 10000 | 16400 | 17100 | 17000 | |
Average | 10000 | 15800 | 17400 | 18400 | |
SD | 0 | 600 | 400 | 1600 |
Validity criteria according to OECD TG 201 (2006)
Solvent control, 0-72 h | |||||||
Growth rate/d | Growth rate/d | Growth rate/d | Growth rate/d | Growth rate/d | Growth rate/d | ||
0 to 24 h | 24 to 48 h | 48 to 72 h | 0 to 72 h | ||||
SD | CV | ||||||
Control Number | |||||||
1 | 1.90359895 | 1.50291759 | 0.75983856 | 1.38878503 | 0.58035906 | 41.7889773 | |
2 | 1.92570744 | 1.55430112 | 0.59038478 | 1.35679778 | 0.68922226 | 50.7977146 | |
3 | 1.87487438 | 1.5989537 | 0.60844391 | 1.36075733 | 0.66596897 | 48.9410532 | |
MW | 1.90139359 | 1.55205747 | 0.65288908 | ||||
CV [%] | 0.01340501 | 0.03096364 | 0.1425358 | ||||
Mean | 1.36878005 | ||||||
SD av.sp.gr. | 0.01743758 | Mean CV | 47.1759151 | limit: <= 35% | |||
% | CV av.sp.gr. | 1.27395028 | limit <= 7% | ||||
Solvent control, 0-48 h | |||||||
Growth rate/d | Growth rate/d | Growth rate/d | Growth rate/d | Growth rate/d | Growth rate/d | ||
0 to 24 h | 24 to 48 h | 48 to 72 h | 0 to 48 h | ||||
SD | CV | ||||||
Control Number | |||||||
1 | 1.90359895 | 1.50291759 | 0.75983856 | 1.13550551 | 0.28332451 | 24.9513985 | |
2 | 1.92570744 | 1.55430112 | 0.59038478 | 1.16000285 | 0.26262393 | 22.6399381 | |
3 | 1.87487438 | 1.5989537 | 0.60844391 | 1.15794269 | 0.19510538 | 16.8493126 | |
Mean | 1.15115035 | ||||||
SD av.sp.gr. | 0.01358793 | Mean CV | 21.4802164 | limit: <= 35% | |||
% | CV av.sp.gr. | 1.18037826 | limit <= 7% |
Description of key information
In the reliable and adequate key study (MOE Japan, 2001) on fresh water green alga growth inhibition performed compliant with GLP according to OECD TG 201 (1984), the following results were obtained (based on geometric mean measured concentrations; in relation to solvent control):
ErC05 (0-72h) : 5.43 mg/L (95% confidence limit: 5.28 - 5.59)
ErC10 (0-72h) : 6.09 mg/L (95% confidence limit: 5.92 - 6.26)
ErC50 (0-72h) : 9.11 mg/L (95% confidence limit: 8.71 - 9.52)
NOEC (0-72 h; growth rate) = 0.574 mg/L (Willilams test, a= 0.05)
LOEC (0-72 h; growth rate) = 1.279 mg/L (corresp. to 4.6% inhibition).
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 9.11 mg/L
- EC10 or NOEC for freshwater algae:
- 6.09 mg/L
Additional information
The reliable and adequate key study (MOE Japan, 2001) on fresh water green alga growth inhibition was performed compliant with GLP according to OECD TG 201 (1984). Selenastrum capricornutum was tested under static exposure conditions for 72 hours exposure. A control, solvent control and 7 nominal test item concentrations (0.250, 0.540, 1.16, 2.50, 5.39, 11.6, 25.0 mg/L) were set up with 3 replicates, each. All test item concentrations were analytically verified at the beginning and the end (72 h) of the test. Measured concentrations were between 65% and 74% of nominal after 0h and between 33 and 36% of nominal after 72 h. Water parameters were measured at the start and end of the test, temperature and illuminance in the incubator were measured at least once a day and found to be within requirements of the guideline. The pH varied from 7.9 at the start of exposure and 10.2 - 10.5 except for the highest test item concentration (8.2 - associated with very poor growth). Due to measured values below 80% of nominal, (no)effect values were derived based on geometric mean measured concentrations.
The following results were obtained with regard to the endpoint growth rate:
ErC05 (0-72h) : 5.43 mg/L (95% confidence limit: 5.28 - 5.59)
ErC10 (0-72h) : 6.09 mg/L (95% confidence limit: 5.92 - 6.26)
ErC50 (0-72h) : 9.11 mg/L (95% confidence limit: 8.71 - 9.52)
NOEC (0-72 h; growth rate) = 0.574 mg/L (Willilams test, a= 0.05)
LOEC (0-72 h; growth rate) = 1.279 mg/L (corresp. to 4.6% inhibition).
No relevant supporting data are available.
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