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EC number: 908-917-6 | 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:
- 24 Sept - 05 Oct 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- adopted 23. Mar. 2006, Annex 5 corrected: 28 July 2011
- Deviations:
- yes
- Remarks:
- see remarks in section "Any other information on material and methods incl tables"
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- adopted 07. December 2015
- Deviations:
- yes
- Remarks:
- see remarks in section "Any other information on material and methods incl tables"
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and all test item concentrations
- Sampling method: Samples were measured at the start and at the end of the test.
- Sample storage conditions before analysis: Samples were stored at - 20 ± 5°C. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Differential loading: The water-accommodated fraction (WAF) was prepared for the test. This was done by weighing the nominal load of 32.0 mg/L, adding the corresponding amount of algal medium and shaking for 23 h The resulting solution was filtrated through 0.45 μm PTFE filters. After filtration, the previously slightly turbid solution was clear. The lower treatments were prepared by dilution of this stock solution with algal medium.
- Controls: medium without test item - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Strain: 86.81
- Source (laboratory, culture collection): The culture was obtained in January 2016 by MBM Sciencebridge GmbH (Institut für Pflanzenphysiologie of Universität Göttingen).
- Age of inoculum (at test initiation): 4 days
- Method of cultivation: The algae are kept as stock culture on solid agar at 2 - 8 °C. From the stock culture, a permanent culture was prepared. From an aliquot of the permanent culture, the pre-culture was prepared.
ACCLIMATION
- Acclimation period: 4 days
- Culturing media and conditions (same as test or not): same - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 22.0 – 23.9 °C
- pH:
- 7.6 - 8.9 (Control)
7.6 - 9.0 (Test item concentrations) - Nominal and measured concentrations:
- Control, 0.32, 1, 3.2, 10 and 32 mg/L (nominal)
- Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open (covered with perforated plastic foil acting as a stopper)
- Material, size, headspace, fill volume: glass vessels 65 mL total volume were filled with 45 ± 1 mL of the test solution
- Initial cells density: 2.3 *10E+03 cells/mL
- Control end cells density: 461.4 *10E+03 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: OECD medium was used according to OECD guideline 201
- Culture medium different from test medium: yes
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: continous illumination
- Light intensity and quality: 5000 lux
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: Cell number was determined with an electronic particle counter after 0, 24, 48 and 72 h
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Range finding study: Test item concentrations to be tested are based on non GLP pre-tests. No details given in study report.- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9)
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 243.11 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval
- Remarks:
- 232.06 – 254.93 μg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 176.72 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval
- Remarks:
- 169.27 – 184.49 μg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 92.47 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control: yes
- Observation of abnormalities: At 0.32 mg/L algae cells partly agglomerated and sedimented; at 32 mg/L no cells were visible
- Any stimulation of growth found in any treatment: growth was stimulated at 3.2 mg/L- Results with reference substance (positive control):
- ErC50 (72 h): 0.65 mg/L
Table 1: Inhibition Values
Nominal concentration
Geometric Mean Measured Concentration
% Inhibition
[mg/L]
[μg/L]
Growth Rate (0-72h)
Yield (0-72h)
Blank control
< LOD
0
0
0.32 1)
< LOD
7.12 1)
31.07 1)
1
60.1
0.3
1.7
3.2
92.5
-0.1
-0.4
10
185.4
13.8*
52.4
32
302.7
81.1*
99.1
Negative inhibition values indicate a stimulation of algal growth compared to the blank control.
1 At the lowest concentration 0.32 mg/L the cells were partly agglomerated and sedimented. Therefore, determination of the cell number might be biased. This effect was not caused by the test item. Because in the next two higher concentrations no inhibition of algal growth was observed, the lowest concentration was excluded from evaluation.
* statistically significant compared to the control
Table 2: Cell Number/mL
Nominal Concentration
Geometric Mean Measured Concentration
Parameter
Cell Number/mL
[mg/L]
[μg/L]
0 h
24 h
48 h
72 h
Blank control
< LOD
Mean
2260
11070
63713
461350
Blank control
< LOD
SD
0
220
3013
37739
0.32 1
< LOD
Mean
2260
10013
45853
318720
0.32 1
< LOD
SD
0
230
5715
58341
1
60.1
Mean
2260
10820
60020
453333
1
60.1
SD
0
819
2961
21671
3.2
92.5
Mean
2260
10040
60307
463360
3.2
92.5
SD
0
364
2230
21326
10
185.4
Mean
2260
6727
29753
220667
10
185.4
SD
0
393
5360
7171
32
302.7
Mean
2260
2993
2920
6413
32
302.7
SD
0 81
191
2127
SD = Standard Deviation, LOD = Limit of detection; 1 At the lowest concentration 0.32 mg/L the cells were partly agglomerated and sedimented. Therefore, determination of the cell number might be biased. This effect was not caused by the test item. Because in the next two higher concentrations no inhibition of algal growth was observed, the lowest concentration was excluded from evaluation.
Table 3: Analytical Results: Calculated Test item Concentration (based on 33.3% component 1) and Geometric Mean 0.06 mg/L
Nominal Concentration Test Item
Calculated Concentration Test item t = 0 h
Calculated Concentration Test item t = 72 h
Geometric Mean
mg/L
μg/L
μg/L
μg/L
1
60.2
60
60.1
3.2
142.5
60
92.5
10
572.6
60
185.4
32
1526.8
60
302.7
LOD (Limit of detection) = 0.06 mg/L (33.3 % purity);
Note: All calculations are performed with unrounded values. Therefore, re-calculation with rounded values may lead to slightly different results
Table 4: Validity criteria
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.
204
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%.
2%
Yes
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”
Reference
Description of key information
ErC50 (72 h): 243.11 µg/L (OECD 201, Desmodesmus subspicatus, based on geometric mean measured concentrations)
ErC10 (72 h): 176.72 µg/L (OECD 201, Desmodesmus subspicatus, based on geometric mean measured concentrations)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 243.11 µg/L
- EC10 or NOEC for freshwater algae:
- 176.72 µg/L
Additional information
The toxicity of the test substance to aquatic algae was investigated according to OECD guideline 201 under GLP conditions including analytical measurement. In this static test, Desmodesmus subspicatus was exposed to five test concentrations (0.32, 1.0, 2.2, 4.6, 10, 22 and 46 mg/L). Due to the low water solubility the test item concentrations were prepared via water-accommodated fractions. This was done by weighing the nominal load of 32.0 mg/L, adding the corresponding amount of algal medium and shaking vigorously for 23 hours. The resulting solution was filtrated through 0.45 μm PTFE filters. The lower treatments were prepared by dilution of this stock solution with algal medium.
Analytical measurement was done by GC/MSD. The test item consists of two components, ethylene glycol monolaurate (component 1) and ethylene glycol dilaurate (component 2), but only one (component 1) is water soluble. The quantification of the test item was performed using the signal of component 1 only. Since the test item was not stable under test conditions, test item could be measured only at the beginning of the test. After 72 hours incubation all measured values were below the LOD.Therefore, the biological results based on the geometric mean of the measured concentrations at the beginning and the LOD (limit of detection).
In the study report an EC50 (72 h) of 0.243.11 mg/L for growth rate was reported based on the geometric mean measured concentrations and an EC10 of 0.1767 mg/L for growth rate. The NOEC (72 h) was reported as 0.09247 mg/L also based on the geometric mean measured concentrations.
According to the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7b (2017) the EC10 value is preferred instead of a NOEL as it is statistically derived from the entire dataset. Therefore the EC10 value was used as chronic toxicity endpoint.
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