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EC number: 277-288-1 | CAS number: 73138-39-3
- 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:
- 30 Oct - 02 Nov 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2006, corrected 28 Jul 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Secrétariat général du GIPC, Ivry-sur-Seine, Cedex, France (15 Nov 2018)
- Analytical monitoring:
- yes
- Remarks:
- GC-MS/MS
- Details on sampling:
- - Concentrations: Control, 0.95, 3.05, 9.76, 31.30 and 100 mg/L (after 0 and 72 h)
- Sample storage conditions before analysis: The samples were immediately analysed. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was poorly soluble under the test conditions. Therefore, the test solutions were prepared as Water Accommodated Fractions (WAFs) according to OECD guideline 23. The WAFs were prepared individually. Respective amounts of the test item were directly added to the test medium and mixed for 24 h to achieve an equilibrated concentration of dissolved and dispersed or emulsified components in the aqueous phase.
- Differential loading: Yes
- Controls: Test medium only, without test item.
- Evidence of undissolved material: Since the test solutions were not filtered, the test solutions were therefore emulsions of the test item. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Unicellular green alga
- Strain: CCAP 1405/1
- Source: Culture Collection of Algae and Protozoa, CCAP
- Age of inoculum: A pre-culture was prepared from the stock culture and maintained in an exponential growth by successive transfers every 3 - 4 d.
- Method of cultivation: The algae were cultured in OECD medium, at 23 ± 2 °C under continuous illumination with intensities in the range of 4440 - 8880 lux - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 22.56 - 22.75 °C
- pH:
- 7.90 (OECD medium)
0 h: 7.90 (control), 7.90 - 8.00 (treatments)
72 h: 8.10 (control), 7.90 - 8.10 (trreatments) - Nominal and measured concentrations:
- Control, 0.95, 3.05, 9.76, 31.30 and 100 mg/L (nominal loading rates for WAFs, see field any other information on results incl. tables for analytical results)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass Erlenmeyer flasks filled with 80 mL test solution and closed with air-permeable polyether foam stoppers.
- Initial cell density: 5000 cells/mL
- Control end cell density: 893383 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- Algal stock culture: A stock culture was maintained on sloped agar tubes at 4 °C and regularly transferred to fresh medium.
GROWTH MEDIUM
- Standard medium used: Yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: OECD medium was reconstituted with chemical reagents and ultra-pure water.
- Culture medium different from test medium: Culture medium same as test medium
- Intervals of water quality measurement: After 0 and 72 h
OTHER TEST CONDITIONS
- Adjustment of pH: 7.90 (OECD medium)
- Photoperiod: Continuous
- Light intensity: 8120 - 8250 lux
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: Cell biomass was measured every day using an electronic particle counter
- Other: The test was performed in a thermostatic chamber. The flasks were maintained under continuous orbital shaking and the flasks were repositioned each day to minimize differences.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 3.2
- Range finding study: Yes, a non-GLP range-finder test was performed, test concentrations: 0.02, 0.2, 2, 20 mg/L (nominal loading rate, WAF).
- Results used to determine the conditions for the definitive study: Yes (54.55% inhibition of growth rate at a nominal loading rate of 20 mg/L (WAF)) - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 3.07 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 16.95 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% confidence limit: 15.58 - 18.65 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 6.85 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- growth rate
- Remarks on result:
- other:
- Remarks:
- 95% confidence limit: 5.76 - 8.23 mg/L
- Details on results:
- - Exponential growth in the control (for algal test): Yes
- Observation of abnormalities: None
- Any stimulation of growth found in any treatment: Stimulation of growth was observed at the nominal loading rate of 0.90 and 3.05 mg/L.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test solutions were emulsions of the test item.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes (dating 18 May 2018)
- ErC50 (72 h): 1.07 mg/L, 95% confidence limits: 0.94 - 1.2 mg/L - Reported statistics and error estimates:
- The EC10 and EC50 were calculated according to Regtox® Macro ("Vindimian"), using the Hill model. The model used in this macro is written in the form proposed by Duggleby in 1981. The confidence intervals on the parameters are estimated by a bootstrap simulation which is entirely non-parameteric and is considered to be well adapted to non-linear models (Efron 1990). The NOEC and LOEC were calculated by R software.
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Reference
VALIDITY CRITERIA
The study fulfilled the validity criteria defined by the guideline (Table 1) and is thus considered valid and reliable.
Table 1: 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. |
Actual value: 179 |
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% |
Actual value: 34.95% |
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. |
Actual value: 4.30% |
Yes |
ANALYTICAL RESULTS
The analytical findings are summarized in Table 2.
Table 2. Analytical results
|
|
Nominal loading rate [mg/L] |
|||||
Time |
Analyte |
Control |
0.95 |
3.05 |
9.76 |
31.30 |
100 |
0 h |
[mg monoester/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
100 |
[mg diester/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
1.52 |
5.21 |
|
[mg diester2/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
1.05 |
0.53 |
|
[mg diester3/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
|
[mg diester4/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
|
48 h |
[mg monoester/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
[mg diester/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
|
[mg diester2/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
|
[mg diester3/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
|
[mg diester4/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
Limit of Quantification (LOQ) = 3.02 mg/L for monoester
LOQ = 0.52 mg/L for diester1
LOQ = 0.73 mg/L for diester2
LOQ = 0.79 mg/L for diester3
LOQ = 0.74 mg/L for diester4
BIOLOGICAL RESULTS
Biological findings are summarized in Table 3, Table 4 and Table 5.
Table 3. Results in control replicates.
|
Number of cells [cells/mL] |
Specific growth rate |
Growth rate [day-1] |
CV growth [%] |
Yield [cells/mL] |
CV yield [%] |
|||||
|
0 h |
24 h
|
48 h |
72 h |
0 – 24 h |
24 – 48 h |
48 – 72 h |
72 h |
72 h |
72 h
|
72 h
|
Control |
5000 |
21444 |
170400 |
1113000 |
1,456 |
2,073 |
1,877 |
1,802 |
4.3 |
1108000 |
23.0 |
5000 |
22514 |
169300 |
1170000 |
1,505 |
2,018 |
1,933 |
1,818 |
1165000 |
|||
5000 |
21942 |
151300 |
898500 |
1,479 |
1,931 |
1,781 |
1,730 |
893500 |
|||
5000 |
9752 |
124400 |
727100 |
0,668 |
2,546 |
1,766 |
1,660 |
722100 |
|||
5000 |
10059 |
92680 |
728100 |
0,699 |
2,221 |
2,061 |
1,660 |
723100 |
|||
5000 |
10240 |
137000 |
723600 |
0,717 |
2,594 |
1,664 |
1,658 |
718600 |
|||
Mean |
5000 |
15992 |
140847 |
893383 |
1,087 |
2,230 |
1,847 |
1,722 |
888383 |
Table 4. Results in treatments.
Nominal loading rate [mg/L] |
Cell number [cells/mL] |
Growth rate [day-1] |
CV growth [%] |
Growth rate inhibition [%] compared to control |
Yield [cells/mL] |
CV yield [%] |
Yield inhibition [%] compared to control |
|||
0 h |
24 h |
48 h |
72 h |
72 h |
72 h |
72 h |
72 h |
72 h |
72 h |
|
0.900 |
5000 |
10165 |
171900 |
1265000 |
1.844 |
4.1 |
-7.14 |
1260000 |
22.8 |
-41.83 |
5000 |
12084 |
125900 |
905500 |
1.733 |
-0.67 |
900500 |
-1.36 |
|||
5000 |
12550 |
145400 |
843600 |
1.709 |
0.70 |
838600 |
5.60 |
|||
Mean |
5000 |
11600 |
147733 |
1004700 |
1.762 |
-2.37 |
999700 |
-12.53 |
||
3.070 |
5000 |
22440 |
153100 |
1193000 |
1.825 |
7.3 |
-6.01 |
1188000 |
34.4 |
-33.73 |
5000 |
25504 |
154900 |
1371000 |
1.871 |
-8.70 |
1366000 |
-53.76 |
|||
5000 |
22218 |
86320 |
662200 |
1.629 |
5.39 |
657200 |
26.02 |
|||
Mean |
5000 |
23387 |
131440 |
1075400 |
1.775 |
-3.10 |
1070400 |
-20.49 |
||
10.02 |
5000 |
10441 |
48840 |
432000 |
1.486 |
8.6 |
13.66 |
427000 |
37.2 |
51.94 |
5000 |
4834 |
47200 |
268200 |
1.327 |
22.89 |
263200 |
70.37 |
|||
5000 |
7505 |
10200 |
217900 |
1.258 |
26.91 |
212900 |
76.04 |
|||
Mean |
5000 |
7593 |
35413 |
306033 |
1.357 |
21.16 |
301033 |
66.11 |
||
31.30 |
5000 |
4500 |
6000 |
11000 |
0.263 |
20.4 |
84.73 |
6000 |
31.8 |
99.32 |
|
5000 |
14913 |
6500 |
13500 |
0.331 |
80.77 |
8500 |
99.04 |
||
|
5000 |
0 |
7000 |
16500 |
0.398 |
76.88 |
11500 |
98.71 |
||
Mean |
5000 |
6471 |
6500 |
13667 |
0.331 |
80.79 |
8667 |
99.02 |
||
100 |
5000 |
2500 |
2000 |
4500 |
0.000 |
173.2 |
100.00 |
0 |
173.2 |
100.00 |
5000 |
1500 |
2500 |
5500 |
0.032 |
98.15 |
500 |
99.94 |
|||
5000 |
2000 |
3500 |
3500 |
0.000 |
100.00 |
0 |
100.00 |
|||
Mean |
5000 |
2000 |
2667 |
4500 |
0.011 |
99.38 |
167 |
99.98 |
Table 5. Effect values (nominal)
NOEC (growth and yield) |
3.07 mg/L |
LOEC (growth and yield) |
10.02 mg/L |
ErC10 (72 h) |
6.85 mg/L (95% confidence limits: 5.76 – 8.23 mg/L) |
ErC50 (72 h) |
16.95 mg/L (95% confidence limits: 15.58 – 18.65 mg/L) |
EyC10 (72 h) |
4.86 mg/L (95% confidence limits: 1.45 – 7.23 mg/L) |
EyC50 (72 h) |
8.08 mg/L (95% confidence limits: 5.14 – 10.45 mg/L) |
Description of key information
ErL10 (72 h) = 6.85 mg/L (nominal loading rate, OECD 201)
ErL50 (72 h) = 16.95 mg/L (nominal loading rate, OECD 201)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 16.95 mg/L
- EC10 or NOEC for freshwater algae:
- 6.85 mg/L
Additional information
One study is available testing the toxicity of the substance towards algae. The study was conducted according to the OECD guideline 201 and GLP standards. Pseudokirchneriella subcapitata was used as the test organism and was exposed to nominal loading rates of 0.95, 3.05, 9.76, 31.30 and 100 mg/L for 72 h. Since the substance fulfils the UVCB criteria and is partly poorly water soluble the test solutions were prepared as water-accommodated fractions (WAF). The test item quantification was performed by GC-MS/MS at 0 and 72 h. The analytical recovery of the constituents in the medium was mostly below the quantification limit. The study resulted into an ErL10 (72 h) = 6.85 mg/L and an ErL50 (72 h) = 16.95 mg/L (nominal loading rates, OECD 201). All validity criteria were met.
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