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EC number: 940-422-0 | 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-04-07 to 2015-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, no deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- EC Number:
- 940-422-0
- Cas Number:
- 1591783-13-9
- Molecular formula:
- C15H31NO6 (C8 derivative) C17H35NO6 (C10 derivative) C19H39NO6 (C12 derivative) C21H43NO6 (C14 derivative) C23H47NO6 (C16 derivative) C25H51NO6 (C18 derivative) C25H49NO6 (C18 unsatd. derivative)
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- Test material form:
- other: waxy
- Details on test material:
- - Molecular formula: C19H39NO6 (C12-Glucamide) and C21H43NO6 (C14-Glucamide)
- Molecular weight: 377.52 – 405.57 g/mol for C12- and C14-Glucamide
- Substance type: UVCB
- Physical state: waxy solid
- Stability under test conditions: Stable (in water and light at room temperature)
- Storage condition of test material: Room temperature, protected from light, in the tightly closed original container
- Other:
- Solubility (in water at RT): Slightly soluble
- pH value (in aqueous solution): Ca. 8-10 at concentration of 10.000 [mg/L]
- Melting point: 70 – 71 °C
- Boiling point: No boiling point, substance decomposes before boiling
- Vapour pressure: < 0.1 Pa
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The test item contents of all test item concentration and control solutions were analytically verified via LC-MS/MS at the beginning and the end of exposure. Separate replicates for the test item analysis at the beginning of the exposure were prepared without algae. For the test item analysis after 72 hours, samples were taken out of the test replicates.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution of 100 mg/L was freshly prepared with dilution water. Agitation until the solution is clear.
- Eluate: Dilution water
- Differential loading: 5 concentrations were tested in a geometrical series with a dilution factor of 3.16:
1.00 - 3.16 - 10.0 - 31.6 - 100 mg/L
The concentrations are based on the results of a preliminary range-finding test (non-GLP).
- Controls: Six replicates (without test item) were incubated under the same test conditions as the test replicates.
- pH-Controls: None
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Desmodesmus subspicatus Chodat
- Strain: SAG 86.81
- Source (laboratory, culture collection): SAG Pflanzenphysiologisches Institut der Universitaet Goettingen, Nikolausberger Weg 18, D-37073 Goettingen, Germany
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 35 - 70 µE x m-2 x 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.: 22.0 max.: 23.0, mean value: 22.5 °C
- pH:
- Nominal pH-value
test item concentration
[mg/L] Start; 0 hours End; 72 hours
100 7.91 7.79
31.6 7.86 7.98
10.0 8.04 8.24
3.16 8.06 8.46
1.00 8.03 8.66
Control 8.17 8.61 - 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 4985 cells/mL
- Control end cells density: Mean 857036 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: 60.4 - 66.8 µE x m^-2 x s^-1, mean value: 63.4 µE x m^-2 x s^-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: [counting chamber; electronic particle counter; fluorimeter; spectrophotometer; colorimeter] fluorimeter:
Chlorophyll-a-fluorescence:
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 Range Finding Test at 100 mg/L.
Microscope evaluation:
Microscopic evaluation of the cells at the start and end of the exposure was carried out. The cells were checked for unusual cell shapes, colour differences, differences in chloroplast morphology, flocculation, adherence of algae to test containers and agglutination of algae cells. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 49 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 37.9-61.8
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 7.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 0.4-13.1
- 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: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test item solutions were clear and have foam formation contingent on the concentrations over the period of exposure.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
Current Study Valid Range (average ± 3 x SD)
Growth Rate Inhibition
ErC50 0.586
0.678 ± 0.414
95 % confidence interval 0.522 - 0.818 0.678 ± 0.414
Yield Inhibition
EyC50 0.401 0.319 ± 0.141
95 % confidence interval 0.285 - 0.469 0.319 ± 0.141
SD = Standard deviation - Reported statistics and error estimates:
- EC-values of the growth rate were calculated by non-linear sigmoidal dose-response regression and yield inhibition by straight line regression..
The values for NOEC/LOEC were determined by calculation of statistical significance of inhibition of growth rate and yield. As standard methods, One Way Analysis of Variance (ANOVA) and DUNNETT’s test were used for NOEC/LOEC calculations. When running a One Way Analysis of Variance, a Normality test and an 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.
Any other information on results incl. tables
Cell Densities
Nominal test item concentration |
Replicate |
Cell density [cells/mL] |
|||||||||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
||||||
100 |
1 |
4985 |
10096 |
10554 |
14304 |
|
|||||
2 |
4985 |
9410 |
13669 |
16902 |
|
||||||
3 |
4985 |
13577 |
15721 |
19808 |
|
||||||
Mean |
4985 |
11028 |
13315 |
17005 |
|
||||||
31.6 |
1 |
4985 |
13051 |
39522 |
221056 |
|
|||||
2 |
4985 |
12754 |
45541 |
175285 |
|
||||||
3 |
4985 |
13686 |
43067 |
209951 |
|
||||||
Mean |
4985 |
13164 |
42710 |
202097 |
|
||||||
10.0 |
1 |
4985 |
15556 |
74147 |
476474 |
|
|||||
2 |
4985 |
16998 |
104834 |
616056 |
|
||||||
3 |
4985 |
19379 |
116192 |
541076 |
|
||||||
Mean |
4985 |
17311 |
98391 |
544535 |
|
||||||
3.16 |
1 |
4985 |
13802 |
62845 |
509598 |
|
|||||
2 |
4985 |
17853 |
63913 |
397339 |
|
||||||
3 |
4985 |
21912 |
71108 |
511646 |
|
||||||
Mean |
4985 |
17856 |
65955 |
472861 |
|
||||||
1.00 |
1 |
4985 |
15697 |
89625 |
695653 |
|
|||||
2 |
4985 |
18202 |
102064 |
760696 |
|
||||||
3 |
4985 |
23526 |
109323 |
836379 |
|
||||||
Mean |
4985 |
19142 |
100337 |
764243 |
|
||||||
Control |
1 |
4985 |
19202 |
136982 |
959840 |
|
|||||
2 |
4985 |
17014 |
112009 |
875044 |
|
||||||
3 |
4985 |
23924 |
127924 |
942295 |
|
||||||
4 |
4985 |
17825 |
97294 |
647955 |
|
||||||
5 |
4985 |
19744 |
116538 |
944583 |
|
||||||
6 |
4985 |
22775 |
109568 |
772500 |
|
||||||
Mean |
4985 |
20081 |
116719 |
857036 |
|
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 [mg/L] |
Replicate |
Growth rate |
Growth rate inhibition |
Yield |
Inhibition of yield |
||
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
|||
100 |
1 |
|
0.35 |
79 |
|
9319 |
99 |
2 |
|
0.41 |
76 |
|
11917 |
99 |
|
3 |
|
0.46 |
73 |
|
14823 |
98 |
|
Mean |
(+) |
0.41 |
76 |
(+) |
12020 |
99 |
|
31.6 |
1 |
|
1.26 |
26 |
|
216071 |
75 |
2 |
|
1.19 |
31 |
|
170300 |
80 |
|
3 |
|
1.25 |
27 |
|
204966 |
76 |
|
Mean |
(+) |
1.23 |
28 |
(+) |
197112 |
77 |
|
10.0 |
1 |
|
1.52 |
11 |
|
471489 |
45 |
2 |
|
1.61 |
6 |
|
611071 |
28 |
|
3 |
|
1.56 |
9 |
|
536091 |
37 |
|
Mean |
(+) |
1.56 |
9 |
(+) |
539550 |
37 |
|
3.16 |
1 |
|
1.54 |
10 |
|
504613 |
41 |
2 |
|
1.46 |
15 |
|
392354 |
54 |
|
3 |
|
1.54 |
10 |
|
506661 |
41 |
|
Mean |
(+) |
1.52 |
12 |
(+) |
467876 |
45 |
|
1.00 |
1 |
|
1.65 |
4 |
|
690668 |
19 |
2 |
|
1.68 |
2 |
|
755711 |
11 |
|
3 |
|
1.71 |
0 |
|
831394 |
2 |
|
Mean |
(-) |
1.68 |
2 |
(-) |
759258 |
11 |
|
Control |
1 |
|
1.75 |
|
|
954855 |
|
2 |
|
1.72 |
|
|
870059 |
|
|
3 |
|
1.75 |
|
|
937310 |
|
|
4 |
|
1.62 |
|
|
642970 |
|
|
5 |
|
1.75 |
|
|
939598 |
|
|
6 |
|
1.68 |
|
|
767515 |
|
|
Mean |
|
1.71 |
|
|
852051 |
|
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 h) |
SD ± |
CV |
Mean CV [%] |
||
section-by-section |
||||||||
0 - 24 hours |
24 - 48 hours |
48 - 72 hours |
||||||
Control |
1 |
1.35 |
1.97 |
1.95 |
1.75 |
0.351 |
20.0 |
18.7 |
2 |
1.23 |
1.89 |
2.06 |
1.72 |
0.437 |
25.4 |
||
3 |
1.57 |
1.68 |
2.00 |
1.75 |
0.223 |
12.8 |
||
4 |
1.27 |
1.70 |
1.90 |
1.62 |
0.318 |
19.6 |
||
5 |
1.38 |
1.78 |
2.09 |
1.75 |
0.359 |
20.5 |
||
6 |
1.52 |
1.57 |
1.95 |
1.68 |
0.237 |
14.1 |
||
|
|
|
Mean |
1.71 |
|
|
||
|
|
|
SD ± |
0.05 |
|
|||
|
|
|
CV [%] |
3.02 |
|
CV = Coefficient of variation
SD = Standard deviation
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, Glucamide CC was found to inhibit the growth of the freshwater green alga Desmodesmus subspicatus after 72 hours with the following effect values: The NOEC-value of the test item for both inhibition of growth rate and inhibition of yield after 72 hours was 1.00 mg/L, the LOEC for both parameters was 3.16 mg/L. The EC50-values with 95 % confidence intervals of the test item for inhibition for growth rate (ErC50) and yield (EyC50) after 72 hours were determined to be 60.1 (46.8 – 76.3) mg/L and 8.18 (5.56 – 11.8) mg/L. All effect levels are given based on the nominal concentrations of Glucamide CC.
- Executive summary:
The toxicity of Glucamide CC (batch number:EK13/177) to the unicellular freshwater green alga Desmodesmus subspicatus was determined according to the principles of OECD 201 (2011) and Council Regulation (EC) 440/2008/Method C.3 at Dr.U.Noack-Laboratorien in 31157 Sarstedt, Germany from 2015-04-07 to 2015-04-10.The aim of the study was to assess 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 4985 cells/mL. A stock solution with a nominal concentration of 100 mg/L was tested. Five concentrations were tested in a geometrical series with a dilution factor of 3.16: 1.00 - 3.16 - 10.0 - 31.6 - 100 mg/L.Three replicates were tested for the test item concentrations and six for the control. Environmental conditions were determined to be within the acceptable limits.
The test item concentration in the test and control solutions were analysed by LC-MS/MS at the start and the end of exposure. The recovery rate of the test item of the fraction C12-Glucamide was in the range of 97 – 118 % of the nominal concentration at the test start and between 102 and 115 % at the test end. The recovery rate of the test item of the fraction C14-Glucamide was in the range of 94 – 114 % of the nominal concentration at the test start and between 89 and 112 % at the test end.
Alleffect valuesof Glucamide CC are given based onthe nominal test item concentrations.NOEC, LOEC, EC-values of Glucamide CC (0-72 hours)
based on nominal test item concentrations [mg/L]
Growth Rate Inhibition
Nominal test item concentration [mg/L]NOEC
1.00
LOEC
3.16
ErC10
8.88 (3.80 – 16.2)
ErC20
22.1 (15.2 – 27.8)
ErC50
60.1 (46.8 – 76.3)
Inhibition of Yield
Nominal test item concentration [mg/L]
NOEC
1.00
LOEC
3.16
EyC10
<1.00
EyC20
<1.00
EyC50
13.3 (7.49 – 21.3)
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.