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EC number: 839-734-9 | CAS number: 2290526-77-9
- 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2019-08-26 to 2019-08-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- 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
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
Test material
- Reference substance name:
- anhydro-D-glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- EC Number:
- 839-734-9
- Cas Number:
- 2290526-77-9
- Molecular formula:
- C15H29NO5 C17H33NO5
- IUPAC Name:
- anhydro-D-glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- Test material form:
- liquid: viscous
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Chemical Analysis of the Test Item Concentrations
Determination of
Samples were analyzed with an LC-MS method, implemented the test item under non-GLP and documented finally in the GLP raw data.
Sampling schedule
All concentration levels and the control were analytically verified via LC-MS at the start (0 hours) of the exposure (72 hours) with algae.
Sampling and pre-treatment
At the start, samples were taken from one additional replicate of each test item concentration and the control and at the end samples were taken from pooled replicates.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Test item solution, media preparation
200 mg test item/L was prepared with dilution water. The dispersion was shaken manually. Undissolved particles were removed by membrane filtration (membrane filter 0.45 µm, RC, MACHEREY-NAGEL). The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate were discarded. The filtration was interrupted for 15 minutes to allow for adsorption and saturation of the filter material with dissolved test item. Thereafter, the filtration was continued. The next 25 mL were discarded. The following filtrate, i.e. the saturated solution, was used in the test. During filtration, the filter was always kept covered. The test item solution was checked via laser beam (Tyndall effect) for undissolved test item. The Tyndall effect was positive.
Preparation of the test item solutions
Out of the stock solution five concentrations were tested in a geometric series with a dilution factor of √10: 2.00 - 6.32 - 20.0 - 63.2 - 200 mg/L.
The dilution levels are based on the results of a preliminary range finding test (non-GLP).
Control
Six replicates (without test item) were exposed under the same conditions as the test concentrations.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata HINDÁK, CCAP 278/4
- 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): 3 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.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
Test conditions
- Hardness:
- Not specified
- Test temperature:
- min.: 21.5 max.: 22.5 mean value: 22.0
- pH:
- Nominal test item concentration pH-values
[mg/L] Start; 0 hours End; 72 hours
200 7.71 8.20
63.2 7.82 8.54
20.0 7.87 9.05
6.32 7.93 9.25
2.00 7.98 9.34
Control 8.10 9.46 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- Nominal and measured concentrations:
- 2.00 - 6.32 - 20.0 - 63.2 - 200 mg/L
- 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 5367 cells/mL
- Control end cells density: Mean 2191749 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:
Ultrapure water was used to prepare the dilution water (conductivity max. 0.1 µS/cm)
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 0.064a2EDTA 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, corresponding to 60 to 120
µE ∙ m-2 ∙ s-1, measured: 5059 - 6039 lux with a mean of 5567 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. Self-fluorescence was observed in the preliminary range finding test at the concentration of 100 mg/L. A separate replicate of each test item concentration were prepared without algae and treated like the other test replicates. The self-fluorescence of the measuring points between 24 and 72 hours were taken into account in the evaluation. - Reference substance (positive control):
- yes
- Remarks:
- (Potassium dichromate)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 6.32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 63.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 44.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI: 40.3 - 48.3
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 78.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI: 72.9 - 85.4
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 200 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 14 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield inhibition
- Remarks on result:
- other: CII: 11.3 - 17.2
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 22.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield inhibition
- Remarks on result:
- other: CI: 19.6 - 26.0
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 48.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield inhibition
- Remarks on result:
- other: CI: 44.9 - 53.3
- 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 were clear throughout exposure period (possible turbidity related to algae growth not taken into account).
- 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 MKBV0900V, purity 99.0%, CAS RN 7778-50-9) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined over a period of 72 hours from 2019-03-05 to 2019-03-08. 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 0.701 0.752 ± 0.534
95% confidence interval 0.660 – 0.750
Yield inhibition
EyC50 0.353 0.405 ± 0.308
95% confidence interval 0.312 – 0.394
SD = Standard deviation - Reported statistics and error estimates:
- EC-values and statistical analyses
EC10-,EC20- and EC50- values with confidence intervals of growth rate inhibition and the EC50- value for yield inhibition after 72 hours were calculated by sigmoidal dose-response regression with the GraphPad Prism Software.
NOEC, LOEC and statistical analyses
The NOEC / LOEC were determined by calculation of statistically significant differences of growth rate and yield using ANOVA. A Shapiro-Wilk’s Normality test and a Brown-Forsythe’s Equal Variance test were done first. P-values for both Normality and Equal Variance tests are 0.05. The -value (acceptable probability of incorrectly concluding that there is a difference) is = 0.05.
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
•SigmaPlot, SPSS INC.
•GraphPad Prism, GRAPHPAD SOFTWARE, INC.
Any other information on results incl. tables
Microscopic evaluation of the cells at the start and the end of exposure revealed no morphological abnormalities. All effect values given are based on the nominal test item concentration of cyclic Glucamide C8- C110
Cell Densities
Nominal test item concentration [mg/L] Replicate Cell density [cells/mL]
No. 0 hours 24 hours 48 hours 72 hours
200 1 5367 4859 21274 204442
2 5367 5165 20290 221694
3 5367 5010 22912 242480
Mean 5367 5011 21492 222872
63.2 1 5367 8556 66081 913919
2 5367 10564 64499 822181
3 5367 11513 72981 813979
Mean 5367 10211 67854 850026
20.0 1 5367 24508 191305 1750263
2 5367 24148 204060 1861545
3 5367 24197 196144 1889390
Mean 5367 24284 197170 1833733
6.32 1 5367 33441 271223 2132739
2 5367 35461 264175 2108448
3 5367 30447 255782 1998236
Mean 5367 33116 263727 2079808
2.00 1 5367 35529 275992 2157586
2 5367 35240 282690 2076047
3 5367 38701 275709 2264828
Mean 5367 36490 278130 2166154
Control 1 5367 36486 317937 2214782
2 5367 33283 288826 2127548
3 5367 35549 278769 2450296
4 5367 32095 268634 2029701
5 5367 30452 239134 2160163
6 5367 35211 277406 2168001
Mean 5367 33846 278451 2191749
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 concentration Replicate Growth rate Inhibition of growth rate Yield Inhibition of yield
[mg/L] No. [d-1] [%] [cells/mL] [%]
200 1 1.21 39 199075 91
2 1.24 38 216327 90
3 1.27 37 237113 89
Mean (+) 1.24 38 (+) 217505 90
63.2 1 1.71 15 908552 58
2 1.68 16 816814 63
3 1.67 16 808612 63
Mean (+) 1.69 16 (+) 844659 61
20.0 1 1.93 4 1744896 20
2 1.95 3 1856178 15
3 1.96 2 1884023 14
Mean (+)* 1.94 3 (+) 1828366 16
6.32 1 2.00 0 2127372 3
2 1.99 1 2103081 4
3 1.97 2 1992869 9
Mean (-) 1.99 1 (-) 2074441 5
2.00 1 2.00 0 2152219 2
2 1.99 1 2070680 5
3 2.02 -1 2259461 -3
Mean (-) 2.00 0 (-) 2160787 1
Control 1 2.01 2209415
2 1.99 2122181
3 2.04 2444929
4 1.98 2024334
5 2.00 2154796
6 2.00 2162634
Mean 2.00 2186382
* = statistically significant but biologically not relevant (inhibition < 5%)
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
1 1.92 2.17 1.94 2.01 0.137 6.82 8.00
2 1.83 2.16 2.00 1.99 0.168 8.43
3 1.89 2.06 2.17 2.04 0.142 6.97
4 1.79 2.13 2.02 1.98 0.172 8.71
5 1.74 2.06 2.20 2.00 0.239 11.9
6 1.88 2.06 2.06 2.00 0.103 5.17
Mean 2.00
SD ± 0.02
CV [%] 1.04
SD = Standard deviation CV = Coefficient of variation
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, cyclic Glucamide C8-C10 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 concentrations): The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were > 200 mg/L and 48.9 (44.9 - 53.3) mg/L, respectively. The NOEC-values for inhibition of growth rate and yield after 72 hours were 20.0 and 6.32 mg/L.
- Executive summary:
The toxicity of cyclic Glucamide C8-C10 (Batch no.: BP 1c (reactor mix)) 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 from 2019-08-26 to 2019-08-29 at the test facility. 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 5367 cells/mL. A test item solution with a nominal concentration of 200 mg test item/L was prepared with dilution water. The dispersion was shaken manually. Undissolved particles were removed by membrane filtration (membrane filter 0.45 µm, RC, MACHEREY-NAGEL). The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate were discarded. The filtration was interrupted for 15 minutes to allow adsorption and saturation of the filter material with dissolved test item. Thereafter, the filtration was continued. The next 25 mL were discarded. The following filtrate, i.e. the saturated solution, was used in the test. During filtration, the filter was always kept covered. The test item solution was checked via laser beam (Tyndall effect) for undissolved test item. The Tyndall effect was positive. Out of the solution five concentrations were tested in a geometrical series with a dilution factor of √10: 2.00 - 6.32 - 20.0 - 63.2 - 200 mg/L. Three replicates were tested for each test item concentration and six replicates for the control. The environmental conditions were within the acceptable limits.
The test media were visually clear throughout the test period. The concentrations of the test item cyclic Glucamide C8-C10 in all concentration levels and the control were analytically verified by LC-MS at the start and at the end of exposure.
The measured concentrations of the test item cyclic Glucamide C8 in the fresh media were in the range of 98 to 101% of the nominal values. At the end of exposure after 72 hours, the measured concentrations were in the range of 101 to 112% of the nominal test item concentrations. The measured concentrations of the test item cyclic Glucamide C10 in the fresh media were in the range of 99 to 103% of the nominal values. At the end of exposure after 72 hours, the measured concentrations were in the range of 98 to 103% of the nominal test item concentrations. The test items remained stable during the course of the study. Therefore, all affect values are given as nominal concentrations.
NOEC, LOEC and ECx-values and 95% Confidence Intervals of cyclic Glucamide C8-C10 (0 - 72 hours)
based on the nominal test item concentration [mg/L]
Inhibition of Growth Rate [mg/L]
NOEC 20.0
LOEC 63.2
ErC10 44.6 (40.3 – 48.3)
ErC20 78.2 (72.9 – 85.4)
ErC50 > 200
Inhibition of Yield [mg/L]
NOEC 6.32
LOEC 20.0
EyC10 14.0 (11.3 – 17.2)
EyC20 22.7 (19.6 – 26.0)
EyC50 48.9 (44.9 – 53.3)
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