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EC number: 264-036-0 | CAS number: 63225-53-6
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- Endpoint summary
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- 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
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- Toxicological Summary
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- Irritation / corrosion
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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:
- 10 - 14 Feb 2015
- 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:
- 28 Jul 2011
- Deviations:
- yes
- Remarks:
- (1) The pH (control) increased by 0.2 (8 - 8.2). Required: max. 1.5 units. (2) Light intensity was 40 instead of the recommended 60 - 120 µE*m^-2*s^-2 but enabled optimal growth to fulfill the OECD quality criteria.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- 24 Aug 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health, Bern, Switzerland (26 Jan 2015)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.100, 0.316, 1.00, 3.16, 10.0, and 31.6 mg/L (nominal). The LOQ is higher than the two lowest test concentrations (0.1 and 0.316 mg/L). This has no influence on the evaluation of the test.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test concentrations were prepared by dilution of a 31.6 mg/L stock solution in algal medium. The pH of the OECD medium was adjusted before inoculation with algal culture (8.0 ± 0.2) and then the test solutions were filter sterilized (0.45 µm cellulose acetate membrane sterility syringe filter, VWR, International)
- Controls: Blank controls containing test medium and algae (6 replicates). - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green unicellular microalgae
- Source: Collection of Algal Culture, Institute of Freshwater Ecology, University of Göttingen, Germany
- Method of cultivation: 250 mL flask containing 100 mL sterile OECD medium inoculated with cell material from axenic slope cultures; Illumination: continuous (2000 - 3000 lux) from Osram Fluora L18W77 and Osram Daywhite L18W840 (Osram AG, Winterthur, Switzerland); Temperature: 22 ± 2 °C
- Other: The culture is re-purchased yearly to control sensitivity. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 22.5 ± 0.6 °C
- pH:
- blank: 8.0 (0 h), 8.2 (72 h)
highest concentration: 7.9 (0 h), 7.8 (72 h) - Nominal and measured concentrations:
- control, 0.100, 0.316, 1.00, 3.16, 10.0, and 31.6 mg/L (nominal)
control, < LOQ,- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL all-glass flasks filled with 100 mL test medium.
- Renewal rate of test solution: No renewal.
- Initial cells density: 2 - 5E+03 cells/mL = 0.5 - 0.85 µg dry weight/mL (i.e. OD680 = ca. 0.005 units)
- Control end cells density: 0.568 units (OD680)
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: Yes (OECD medium)
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: Same as test.
- Intervals of water quality measurement: pH was measured at 0 and 72 h in the medium which is used for the control and in the saturated solutions.
OTHER TEST CONDITIONS
- Sterile test conditions: The test solutions were filter sterilized (0.45 µm cellulose acetate membrane sterile syringe filter, VWR, International).
- Adjustment of pH: The pH of the OECD medium was adjusted before inoculation with algal culture (pH 8.0 ± 0.2).
- Photoperiod: Continuous
- Light intensity and quality: ca. 3000 lux (40 µE*m^-2*s^-2) from Osram Fluora L18W77 and Osram Daywhite L18W840 (Osram AG, Winterthur, Switzerland). The light intensity is maintained within ± 6% of the average light intensity over the incubation area (required: ± 15%). The present light intensity is lower than the the 60 - 120 µE*m^-2*s^-2 recommended by the OECD testing guideline 202. However, based on the laboratory experience, the two lamps enable optimal growth conditions at a light intensity of 40 mE*m^-2*s^-2 to fulfill the required quality criteria according to OECD while yielding the "fittest" algal cells.
EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: Spectrophotometer (wavelength: 680 nm) after 0, 24, 48 and 72 h.
- Other: Aliquots of 5 mL were removed from each test flask under sterile conditions. Cell concentrations at 0 h were only determined in the control vessels.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.16
- Range finding study: Yes, non-GLP.
- Test concentrations: 1, 10, and 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: Yes. In the range finding test inhibition of the average growth rate was 19, 60, and 102% at concentrations 1, 10, and 100 mg/L (nominal), respectively.- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1.04 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval: 0.625 - 1.47 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5.98 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% confidence interval: 4.95 - 7.23 mg/L
- Details on results:
- - Exponential growth in the control: Yes, the biomass in the control cultures increased exponentially by a factor of > 16 within the 72 h test period corresponding to an average specific growth rate of 1.51 (required: > 0.92).
- Observation of abnormalities: No
- Effect concentrations exceeding solubility of substance in test medium: No- Reported statistics and error estimates:
- The ErC50 and EyC50 values were calculated using ToxRat Standard Version 2.10 (ToxRat Solutions GmbH, Alsdorf, Germany). For the calculation of confidence intervals, values below 0% were set to 0.1% inhibition. Data were fit with the Logit regression model and the NOEC was determined by Dunnett´s test.
ANALYTICAL RESULTS
The LOQ of the method (0.5 mg/L) is higher than the two lowest test concentrations (0.100 and 0.316 mg/L). This has, however, no influence on the evaluation of the test.
HPLC measurements showed that the geometric mean measured test concentrations were within 91 - 105% of the nominal concentrations after 72 h, indicating that the test item was fully dissolved and stable for the duration of the test. Since test concentrations were maintained within ± 20% of the nominal concentrations throughout the test, effect concentrations were calculated based on nominal concentrations.
BIOLOGICAL RESULTS
The calculated median effect concentration ErC50 based on growth rate was 5.98 mg/L (95% CI: 4.95 - 7.23 mg/L), the ErC10 (72 h) was 1.04 mg/L (95% CI: 0.625 - 1.47 mg/L) and the NOErC (72 h) was 0.100 mg/L.
With respect to biomass production, the calculated EyC50 (72 h) was 1.28 mg/L (95% CI: 1.23 - 1.34 mg/L) and the NOEyC (72 h) was < 0.100 mg/L.
Table 1. Average specific growth rates between 0 and 72 h of exposure.
Nominal concentration [mg/L]
Replicate
GRaa)
µ3-0[d^-1]b)
GRaa)
µ3-0[d^-1]b)
mean values
Coefficient of variation [%]
Inhibition
[%]
Inhibition mean value [%]
Control
A
1.511
1.51
b)
0.1
c)
0.2
0.1
0.0
-0.1
0.0
-0.1
0.0
B
1.513
C
1.515
D
1.517
E
1.514
F
1.517
0.100
A
1.505
1.50
0.5
0.6
1.5
0.6
0.9
B
1.492
C
1.506
0.316
A
1.477
1.48
0.0
2.5
2.5
2.6
2.5
B
1.476
C
1.476
1.00
A
1.341
1.34
0.3
11.5
11.0
11.3
11.3
B
1.349
C
1.343
3.16
A
0.981
0.99
1.2
35.2
33.7
35.0
34.6
B
1.004
C
0.984
10.0
A
0.686
0.66
4.7
54.7
58.8
56.7
56.7
B
0.624
C
0.656
31.6
A
-0.061
-0.06
0.0
104.0
104.0
104.0
104.0
B
-0.061
C
-0.061
a)Average specific growth rate during the whole test period 0 – 3 d.
b)The biomass in the control cultures increased exponentially by a factor of > 16 within the 72 h test period corresponding to an average specific growth rate of 1.51 (required: > 0.92).
c)The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures was 0.1% (required: ≤ 7%).
Reference
Description of key information
ErC10 (72 h) = 1.04 mg/L (nominal, OECD 201, D. subspicatus)
ErC50 (72 h) = 5.98 mg/L (nominal, OECD 201, D. subspicatus)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 5.98 mg/L
- EC10 or NOEC for freshwater algae:
- 1.04 mg/L
Additional information
There is one key GLP study available investigating the toxic effects of the substance toward aquatic algae according to the OECD guideline 201.
In a static test, Desmodesmus subspicatus was exposed to the nominal test item concentrations of 0.1, 0.316, 1.0, 3.16, 10.0, and 31.6 mg/L under continuous light and controlled conditions for 72 h. A control was run in parallel. Since the test substance is soluble, the test solutions were prepared by the serial dilution of a 31.6 mg/L stock solution. The actual test concentrations were analytically verified by HPLC at the beginning (0 h), and after 24, 48 h and 72 h of exposure.
The geometric mean measured concentrations were 92 – 105% of the nominal concentration, showing that the test item was fully dissolved and stable throughout the duration of the test. Since the test concentrations were within ± 20% of the nominal concentrations, the effective concentrations (ErCx and EyCx) were calculated based on the nominal concentrations.
The calculated 72 h ErC10 was 1.04 mg/L (95% CI: 0.625 – 1.47 mg/L) and the ErC50 was 5.98 (95% CI: 4.95 – 7.23). The obtained NOErC (72 h) was 0.100 mg/L.
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