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EC number: 942-425-2 | CAS number: -
- 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 2015-02-16 to 2015-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 201 without any deviation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected on June 03-05, 2013 / signed on November 05, 2013
- Specific details on test material used for the study:
- - Water solubility in pure water: isomer 1 = 125 µg/L; isomer 2 = 285 µg/L
- Water solubility in M4 medium: isomer 1 = 115 µg/L; isomer 2 = 261 µg/L
(determined at Dr. U.NOACK-LABORATORIEN, Noack Lab-ID: 131029FG/CWE15836) - Analytical monitoring:
- yes
- Details on sampling:
- The saturated solution and the control were analytically verified via GC-MS at the beginning and the end of exposure. Separate replicates for the test item analysis at the beginning of the exposure were prepared without algae. For the test item analysis after 72 hours, separate replicates were prepared with algae at the beginning of exposure and incubated under test conditions.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The saturated solution with a nominal loading of 2.00 mg/L was prepared once with dilution water. The saturated solution was stirred for 24 hours (1100 rpm) with a magnetic stirrer.
- Controls: Six replicates (without test item) were tested under the same test conditions as the test vessels. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: Pseudokirchneriella subcapitata HINDÁK, SAG 61.81
- Source: Sammlung von Algenkulturen (SAG), Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, D-37073 Göttingen
- Age of inoculum (at test initiation): A four days old preculture, prepared in dilution water, was used as inoculum.
- Method of cultivation: Fresh stocks are prepared every month on Z-Agar. Light intensity amounted to 35-70 µE/m2/s for 24 hours per day.
- Culture medium: Nutrient medium Z according to LÜTTGE et al. (1994) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- none
- Post exposure observation period:
- None
- Hardness:
- Dilution water medium has a nominal hardness of 0.24 mmol Ca+Mg/L
- Test temperature:
- 21.8-23.5 °C (22.7 °C)
- pH:
- 8.20 - 9.49
- Dissolved oxygen:
- None
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal concentrations: Saturated solution with a nominal loading rate of 2.00 mg/L was tested as a limit test loading.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Sterile headspace flasks, volume: 119 mL, with aluminium tops with PTFE seals
- Test volume: 119 mL
- Initial cells density: Nominal: approximately 1 x 10^4 cells/mL; Current: 7085 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
- Application: Application was carried out by adding appropriate volumes of the saturated solution to the test replicates.
- Incubation: The flasks were positioned randomly and repositioned daily.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to the OECD guideline 201
OTHER TEST CONDITIONS
- Agitation: Test containers were placed on a rotary shaker and oscillated at approximately 100 rpm.
- Photoperiod: 24 hours/day light
- Light intensity and quality: 84.2 to 94.1 (90.4) µE/m2/s
- Light homogeneity: Within ± 15 % over incubation area
EFFECT PARAMETERS MEASURED:
- 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 background signal. No self-fluorescence was found in the range finding and in the definitive test at the nominal concentration level of 2.00 mg/L.
- Microscopic evaluation: Microscopic evaluation of the cells was carried out daily. The cells were checked for any unusual cell shapes, colour differences, differences in chloroplast morphology, flocculation and adherence of algae to test containers or aggregation of algae cells.
Physical Chemical Parameters:
- The pH-value at the beginning and end of the test was measured from pooled replicates per concentration and control after measurement of the cell density, respectively. The room temperature was measured continuously. The light intensity was measured prior to the test start.
TEST CONCENTRATIONS
- Range finding study: In a non-GLP preliminary range finding test, three nominal test concentrations of 20, 200 and 2000 µg/L were tested. Inhibition of growth rate was -3, -3 and 3 % at test concentrations of 20, 200 and 2000 µg/L after 72 h. Respective inhibitions of yield were -10, -12 and 13 %. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 1.42 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: > solubility limit
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1.42 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: > solubility limit
- Details on results:
- Biological data:
Microscopic evaluation of the cells at the start of the incubation period and at test end revealed no morphological abnormalities in saturated solution and control. All effect values are given based on geometric mean measured test item concentration.
Measured Exposure Concentrations during the Definitive Test:
The concentrations of the test item was determined at the start of exposure (0 h) and at the end of the exposure in the test item loading level and the control via GC-MS. The measured concentration of the test item at the start of exposure was 101 % of the nominal value. At the end of exposure the measured concentration was 50 % of the nominal value. All effect values given were based on geometric mean measured concentrations of the test item. - Results with reference substance (positive control):
- - Results with reference substance valid
- The ErC50 value based on Growth Rate Inhibition: 0.749 mg/L (with Headspace) and 0.774 (without Headspace)
- The EyC50 value based on Yield Inhibition: 0.282 mg/L (with Headspace) and 0.502 (without Headspace) - Reported statistics and error estimates:
- EC-values and statistical analyses: EC-values of the growth rate and yield inhibition were estimated empirically based on the results of the only treatment level (limit test design).
NOEC, LOEC and statistical analyses: The NOEC / LOEC was determined by calculation of statistically significant differences of growth rate and yield. As a standard, One Way Analysis of Variance (ANOVA) and Dunnett’s test were used for NOEC/LOEC 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 α-value (acceptable probability of incorrectly concluding that there is a difference) is α = 0.05. Normality Test failed first for yield data but was passed after a square root data transformation. - Validity criteria fulfilled:
- yes
- Conclusions:
- Only 3% inhibition of the growth rate was observed at the geometric mean measured concentration of 1.42 mg/L. Therefore, the 72h-ErC10 and 72h-ErC50 were determined to be greater than this value, greater than the solubility limit.
- Executive summary:
In an algal growth inhibition study performed according to OECD Guideline 201and in compliance with GLP, freshwater green algae species Pseudokirchneriella subcapitata was exposed to test material at the nominalloading level of 2.00 mg/Lfor 72 h. The study was conducted under static conditions with an initial cell density of 7085 cells/mL. Six replicates were tested for the test item concentration and for the control, respectively. The environmental conditions were within the acceptable limits.
The concentration of the saturated solution of the test item and the control were analytically verified via GC-MS at the start and the end of exposure. The recovery rate ofthe test item at the start was 101 %, at the test end it was determined to be 50 %. Therefore, all effect values were based on the geometric mean measured test item loading rate (1.42 mg/L).
Under the test conditions, only 3% inhibition of the growth rate was observed at the geometric mean measured concentration of 1.42 mg/L. Therefore, the 72h-ErC10 and 72h-ErC50 were determined to be greater than this value, greater than the solubility limit.
Reference
Table 6.1.5/1: Cell Densities (Geometric mean measured test item concentrations)
Geometric mean measured test item concentration |
Replicate |
Cell density [cells/mL] |
|||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
1.42 |
1 |
7085 |
18971 |
139626 |
559075 |
2 |
7085 |
18253 |
118265 |
552468 |
|
3 |
7085 |
15189 |
135934 |
562461 |
|
4 |
7085 |
11989 |
132787 |
619731 |
|
5 |
7085 |
22470 |
144241 |
539122 |
|
6 |
7085 |
22686 |
153902 |
565848 |
|
Mean |
7085 |
18260 |
137459 |
566451 |
|
Control |
1 |
7085 |
28403 |
176033 |
592474 |
2 |
7085 |
22440 |
157873 |
626139 |
|
3 |
7085 |
26600 |
179074 |
559772 |
|
6 |
7085 |
28416 |
180250 |
631418 |
|
7 |
7085 |
24060 |
185840 |
643934 |
|
8 |
7085 |
32596 |
201790 |
770260 |
|
Mean |
7085 |
27086 |
180143 |
637333 |
Table 6.1.5/2: Evaluation after 72 hours
Geometric mean measured test item concentration |
Replicate |
Growth rate |
Inhibition of growth rate |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
1.42 |
1 |
|
1.46 |
3 |
|
551990 |
12 |
2 |
|
1.45 |
3 |
|
545383 |
13 |
|
3 |
|
1.46 |
3 |
|
555376 |
12 |
|
4 |
|
1.49 |
1 |
|
612646 |
3 |
|
5 |
|
1.44 |
4 |
|
532037 |
16 |
|
6 |
|
1.46 |
3 |
|
558763 |
11 |
|
Mean |
(+) |
1.46 |
3 |
(+) |
559366 |
11 |
|
Control |
1 |
|
1.48 |
|
|
585389 |
|
2 |
|
1.49 |
|
|
619054 |
|
|
3 |
|
1.46 |
|
|
552687 |
|
|
4 |
|
1.50 |
|
|
624333 |
|
|
5 |
|
1.50 |
|
|
636849 |
|
|
6 |
|
1.56 |
|
|
763175 |
|
|
Mean |
|
1.50 |
|
|
630248 |
|
Statistically significant differences of growth rates and yield compared to control values are marked (+), not significant differences are marked (-).
Table 6.1.5/3:Section-by-Section and Average Specific Growth Rates of 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 |
1.39 |
1.82 |
1.21 |
1.48 |
0.314 |
21.3 |
24.0 |
2 |
1.15 |
1.95 |
1.38 |
1.49 |
0.412 |
27.5 |
||
3 |
1.32 |
1.91 |
1.14 |
1.46 |
0.401 |
27.5 |
||
4 |
1.39 |
1.85 |
1.25 |
1.50 |
0.311 |
20.8 |
||
5 |
1.22 |
2.04 |
1.24 |
1.50 |
0.469 |
31.2 |
||
6 |
1.53 |
1.82 |
1.34 |
1.56 |
0.244 |
15.6 |
||
NA |
Mean |
1.50 |
NA |
|
||||
SD ± |
0.04 |
|
||||||
CV [%] |
2.40 |
|
SD = Standard deviation CV = Coefficient of variation
Table 6.1.5/4: Environmental Conditions
Geometric mean measured test item concentration |
pH-value |
||
[mg/L] |
Start; 0 hours |
End; 72 hours |
|
1.42 |
8.20 |
9.49 |
|
Control |
8.21 |
9.47 |
|
Room temperature [°C]: |
min.: 21.8 |
max.: 23.5 |
mean value: 22.7 |
Light intensity |
n = 20 |
mean value: 90.4 range of the measured values: 84.2 to 94.1 equalling -6.81 to 4.15 % |
CV [%]: 3.11 |
CV = Coefficient of variation n = number of measuring points
The study meets the validity criteria of the guideline:
Validity Criteria
Validity Criterium |
Required |
This study |
Increase of the cell growth in the control cultures |
Exponentially > 16-fold corresponding to a specific growth rate of 0.92 day-1 |
90-fold |
Mean coefficients of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3) in the control cultures |
< 35 % |
24.0 % |
Coefficient of variation of average specific growth rates during the whole test period in replicate control cultures |
< 7 % |
2.40 % |
Description of key information
OECD Guideline 201, GLP, key study, validity 1:
No effects were observed on Pseudokirchneriella subcapitata up to the solubility limit of the test substance.
Key value for chemical safety assessment
Additional information
To assess the toxicity of the registered substance to aquatic algae, one valid study is available.
This GLP study, assessed as a key study, was performed on the registered substance according to OECD Guideline 201. The unicellular freshwater green alga Pseudokirchneriella subcapitata was exposed to a saturated solution of the test substance with a nominal loading level of 2 mg/L and a control, under static conditions, over a period of 72 hours. The concentrations of the saturation solution of the test substance and the control were analytically verified via GC-MS at the start and at the end of the exposure. The recovery rate of the test substance at the start was 101% and at the test end it was determined to be 50%. Therefore, all effects values were based on geometric mean measured test substance loading rate. According to the results of this study, only 3% inhibition of the growth rate was observed at the geometric mean measured concentration of 1.42 mg/L. Therefore, the 72h-ErC10 and 72h-ErC50 were determined to be greater than this value, greater than the solubility limit.
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