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EC number: - | 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 2021-01-25 to 2021-01-29, with the definitive exposure phase from 2021-01-25 to 2021-01-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test item
Samples were analyzed with an LC-MS/MS method, implemented under non-GLP and documented finally in the GLP raw data. The method was validated.
Sampling schedule
All loading rates and the control were analytically verified via LC-MS/MS at the start (0 hours) and at the end of the exposure (72 hours) with algae.
Sampling and pre-treatment
At the start of the exposure, samples were taken from one additional replicate of each test item loading rate and the control and at the end samples were taken from pooled replicates. - Vehicle:
- no
- Details on test solutions:
- Preparation of the water accommodated fractions
Five water accommodated fractions (WAF) were prepared separately with nominal loading rates of the test item in the range of 1.00 to 100 mg/L set up in a geometric series with a factor of √10: 1.00 – 3.16 – 10.0 – 31.6 – 100 mg/L. For each loading rate, an appropriate amount of the test item was weighed and transferred with an appropriate amount of the dilution water into a measuring flask. The WAFs were treated with ultrasound for 5 minutes at room temperature and manual agitation. The WAFs were checked via laser beam (Tyndall effect) for undissolved test item.
The test media were visually clear throughout the test period. A positive Tyndall effect were observed at the WAFs 10.0 to 100 mg/L. The Tyndall effect was negative at the WAFs 1.00 and 3.16 mg/L. The WAFs showed a concentration related foaming.
Test item loading rates
Per definition of the WAF all terms related to concentration level have to be given as loading rates because partly dissolved compounds and mixtures cannot be related to concentrations. The loading rates are based on the results of a preliminary range finding test (non-GLP, open system with headspace).
Control
Six replicates (without test item) were exposed under the same conditions as the WAFs. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata HINDÁK
- Strain: CCAP 278/4
- Source (laboratory, culture collection): Culture Collection of Algae and Protozoa (CCAP), SAMS Research Services Ltd, Dunstaffnage Marine Laboratory Dunbeg, OBAN; Argyll PA37 1QA; Scotland, UK
- Age of inoculum (at test initiation): 4 days
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 2567 – 5130 lux corresponding to 35 - 70 µE ∙ m-2 ∙ s-1 for 24 h per day. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
- Hardness:
- Not specified
- Test temperature:
- min.: 22.0 max.: 23.0 mean value: 22.5
- pH:
- Nominal test item loading pH-values
[mg/L] Start; 0 hours End; 72 hours
100 7.96 7.80
31.6 7.98 7.90
10.0 8.04 8.05
3.16 8.05 8.28
1.00 8.13 8.44
Control 8.08 8.55 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Type (delete if not applicable): open, cotton wool plugs
- Material, size, headspace, fill volume: sterile 250 mL Erlenmeyer flasks, test volume 100 mL
- Aeration: Test containers were placed on a rotary shaker and oscillated at appr. 70 rpm
- Type of flow-through (e.g. peristaltic or proportional diluter): None
- Renewal rate of test solution (frequency/flow rate): One application at test start
- Initial cells density: Nominal: approximately 2 - 5 x 10^3 cells/mL, Actual: mean 5375 cells/mL
- Control end cells density: Mean 776762 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Composition of Dilution Water
according to the guideline
Component Concentration [mg/L]
NH4Cl 15
MgCl2 x 6 H2O 12
CaCl2 x 2 H2O 18
MgSO4 x 7 H2O 15
KH2PO4 1.6
FeCl3 x 6 H2O 0.064
Na2EDTA x 2 H2O 0.1
H3BO3 0.185
MnCl2 x 4 H2O 0.415
ZnCl2 3 x 10^-3
Na2MoO4 x 2 H2O 7 x 10^-3
CoCl2 x 6 H2O 1.5 x 10^-3
CuCl2 x 2 H2O 1 x 10^-5
NaHCO3 50
pH 8.1 ± 0.2
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 h
- Light intensity and quality: Approximately 4440 to 8880 lux, range of the measured values: 5006 - 6389 / equalling -12.2 to 12.06%, mean value: 5701 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
-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 a background signal. No self-fluorescence was found in the definitive test in the saturated solution. - Reference substance (positive control):
- yes
- Remarks:
- (Potassium dichromate)
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 6.17 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Cl: 4.77-7.54
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Effect conc.:
- 2.49 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: Cl: 2.19-2.81
- Duration:
- 72 h
- Dose descriptor:
- EL20
- Effect conc.:
- 7.88 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Cl: 6.63-8.75
- Duration:
- 72 h
- Dose descriptor:
- EL20
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: Cl: 2.90-3.53
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 11.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI: 11.0 - 13.8
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- 5.32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: CI:4.88 - 5.81
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test):
- Unusual cell shape: No
- Colour differences: No
- Flocculation: No
- Adherence to test vessels: No
- Aggregation of algal cells: No
- Other: The test media clear throughout the exposure period.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- The toxicity of potassium dichromate (SIGMA ALDRICH, batch number BCCC1619, purity 100.0%, CAS RN 7778-50-9) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined over a period of 72 hours from 2020-10-20 to 2020-10-23. The reference item toxicity is in the valid range which was established by calculation of the average of the historic reference data since 2006, and the limits were set using the threefold standard deviation of these values.
EC50-Values of the Reference Item
based on nominal concentrations mg/L, (0-72 hours)
Current Study Valid Range (average ± 3 x SD)
Growth Rate inhibition
ErC50 0.903 0.775 ± 0.558
95% confidence interval 0.858 – 0.946
Yield inhibition
EyC50 0.441 0.421 ± 0.339
95% confidence interval 0.421 – 0.462
SD = Standard deviation - Reported statistics and error estimates:
- EL-values and statistical EL10-,EL20- and EL50- values with confidence intervals of growth
analyses rate inhibition and for yield inhibition after 72 hours were calculated by sigmoidal dose-response regression with the GraphPad Prism Software.
NOEL, LOEL and The coefficients of variation of the control group are within the valid
analyses ranges but indicate that significance tests are not sensitive. Therefore, no NOEC/LOEC values are given.
Software The data for the tables in this report were computer-generated and have been rounded for presentation from the full derived data. Consequently, if calculated manually based on the given data minor deviations may occur from these figures.
Calculations were carried out using software
• Excel, MICROSOFT CORPORATION
• GraphPad Prism, GRAPHPAD SOFTWARE, INC.
• ToxRat Professional, Version 3.3.0, ToxRat Solutions GmbH - Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, cyclic Glucamide C12-14 was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours with the following effect values (based on the nominal test item loadings): The EL50-values for inhibition of growth rate (ErL50) and yield (EyL50) after 72 hours were 11.8 (95% CI: 11.0 – 13.8) mg/L and 5.32 (95% CI: 4.88 – 5.81) mg/L, respectively.
- Executive summary:
The toxicity of cyclic Glucamide C12-14 (batch number: S148866) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and Council Regulation (EC) No. 266/2016/Method C.3 at the test facility from 2021-01-25 to 2021-01-29, with the definitive exposure phase from 2021-01-25 to 2021-01-28. The aim of the study was the determination of the effects on growth rate and yield over a period of 72 hours.
The study was conducted under static conditions with an initial cell density of 5375 cells/mL. Five water accommodated fractions (WAFs) were freshly prepared at the start of exposure with nominal loading rates of the test item in the range of 1.00 to 100 mg/L set up in a geometric series with a factor of √10: 1.00 – 3.16 – 10.0 – 31.6 – 100 mg/L.
Three replicates were tested for each WAF and six replicates for the control. The environmental conditions were within the acceptable limits.
The test media were visually clear throughout the test period. A positive Tyndall effect were observed at the WAFs 10.0 to 100 mg/L. The Tyndall effect was negative at the WAFs 1.00 and 3.16 mg/L. The WAFs showed a concentration related foaming.
The concentrations of the test item cyclic Glucamide C12-14 and the control were determined in fresh media (0 hours) and old media (72 hours) of all tested concentration levels and the control via LC-MS/MS.
The measured concentrations of the test item cyclic Glucamide C12-14 in the fresh media were in the range of 91 to 106% of the nominal values. At the end of exposure after 72 hours, the measured concentrations were in the range of 88 to 113% of the nominal test item concentrations.
All effect values are given as nominal loading rates.
NOEL, LOEL and ELx-values (with 95% Confidence Intervals) of cyclic Glucamide C12-14 after 72 hours of exposure
based on the nominal loading rates of the test item [mg/L]
cyclic Glucamide C12-14
Nominal loading rates of the test item [mg/L]
Inhibition of Growth Rate
ErL10 6.17 (95% CI: 4.77 – 7.54)
ErL20 7.88 (95% CI: 6.63 – 8.75)
ErL50 11.8 (95% CI: 11.0 – 13.8)
Inhibition of Yield
EyL10 2.49 (95% CI: 2.19 – 2.81)
EyL20 3.20 (95% CI: 2.90 – 3.53)
EyL50 5.32 (95% CI: 4.88 – 5.81)
The coefficients of variation of the control group are within the valid ranges but indicate that significance tests are not sensitive (for an example see part 15.3). Therefore, no NOEC/LOEC values are given.
Reference
Cell Densities
Nominal test item loading rates Replicate Cell density [cells/mL]
[mg/L] No. 0 hours 24 hours 48 hours 72 hours
100 1 5375 <LOQCell density <LOQCell density <LOQCell density
2 5375 <LOQCell density <LOQCell density <LOQCell density
3 5375 <LOQCell density <LOQCell density <LOQCell density
Mean 5375 n.a. n.a. n.a.
31.6 1 5375 <LOQCell density 3853 6262
2 5375 <LOQCell density 3469 6164
3 5375 <LOQCell density 2848 5067
Mean 5375 n.a. 3390 5831
10.0 1 5375 8986 23872 156369
2 5375 9421 28542 166446
3 5375 4078 14162 81793
Mean 5375 7495 22192 134869
3.16 1 5375 16007 90685 644866
2 5375 14912 74597 645232
3 5375 15645 79132 589472
Mean 5375 15521 81471 626523
1.00 1 5375 18822 103460 779530
2 5375 17751 97380 789670
3 5375 20476 112129 844918
Mean 5375 19016 104323 804706
Control 1 5375 18152 62778 555006
2 5375 16957 97417 901470
3 5375 18255 66678 907579
4 5375 19762 67430 852087
5 5375 21016 112420 906552
6 5375 18377 116476 537877
Mean 5375 18753 87200 776762
n.a. = not applicable LOQCell density = 2280 cells/mL
Evaluation after 72 hours
Statistically significant differences of growth rates and yield compared to control values are marked (+), not significant differences are marked (/).
Nominal test item loading rates Replicate Growth rate Inhibition of growth rate Yield Inhibition of yield
[mg/L] No. [d-1] [%] [cells/mL] [%]
100 1 n.a. 100 n.a. 100
2 n.a. 100 n.a. 100
3 n.a. 100 n.a. 100
Mean (+) n.a. 100 (n.d.) n.a. 100
31.6 1 0.05 97 887 100
2 0.05 97 789 100
3 -0.02 100 -308 100
Mean (+) 0.03 98 (n.d.) 456 100
10.0 1 1.12 32 150994 80
2 1.14 31 161071 79
3 0.91 45 76418 90
Mean (+) 1.06 36 (+) 129494 83
3.16 1 1.60 3 639491 17
2 1.60 3 639857 17
3 1.57 5 584097 24
Mean (/) 1.59 4 (/) 621148 19
1.00 1 1.66 -1 774155 0
2 1.66 -1 784295 -2
3 1.69 -2 839543 -9
Mean (/) 1.67 -1 (/) 799331 -4
Control 1 1.55 549631
2 1.71 896095
3 1.71 902204
4 1.69 846712
5 1.71 901177
6 1.54 532502
Mean 1.65 771387
n.a. = not applicable
n.d. = not determined, since inhibition was 100% at the two highest loading rates
Section-by-Section and Average Specific Growth Ratesof 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 1.22 1.24 2.18 1.55 0.549 36 32.9
2 1.15 1.75 2.23 1.71 0.539 32
3 1.22 1.30 2.61 1.71 0.781 46
4 1.30 1.23 2.54 1.69 0.735 43
5 1.36 1.68 2.09 1.71 0.363 21
6 1.23 1.85 1.53 1.54 0.309 20
Mean 1.65
SD ± 0.08
CV [%] 5.14
SD = Standard deviation CV = Coefficient of variation
|
SD = Standard deviation CV = Coefficient of variation
Description of key information
In this study, cyclic Glucamide C12-14 was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours with the following effect values (based on the nominal test item loadings): The EL50-values for inhibition of growth rate (ErL50) and yield (EyL50) after 72 hours were 11.8 (95% CI: 11.0 – 13.8) mg/L and 5.32 (95% CI: 4.88 – 5.81) mg/L, respectively.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 11.8 mg/L
- EC10 or NOEC for freshwater algae:
- 6.17 mg/L
Additional information
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