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EC number: 615-027-9 | CAS number: 69904-10-5
- 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:
- 2011-09-13 to 2011-09-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- 6-amino-7-methoxy-1,2,3,4-tetrahydroquinoxaline-2,3-dione
- EC Number:
- 615-027-9
- Cas Number:
- 69904-10-5
- Molecular formula:
- C9H9N3O3
- IUPAC Name:
- 6-amino-7-methoxy-1,2,3,4-tetrahydroquinoxaline-2,3-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Amino-C-Dion trocken
- Molecular formula: C9H9N3O3
- Molecular weight: 207.19 g/mol
- Physical state: Solid, yellow powder
- Expiration date of the lot/batch: 2013-05-04
- Stability under test conditions: Not applicable
- Storage condition of test material: Room temperature, protected from light, in original container
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: The concentrations of the test item were analytically determined from all test concentrations and the control after 0 hours (test start) and 72 hours (test end).
- Sampling method: Samples at test start were taken from an additional replicate without algae. At end of the test samples were taken directly from the pooled test replicates.
- Sample storage conditions before analysis: All original samples were stored at 6 ± 2 °C until sample preparation, if necessary. Prepared samples were stored at room temperature until analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution of 160 mg/L was freshly prepared with dilution water. The stock solution was treated with ultrasound for 15 min and stirred with approximately 1100 rpm for 1 h at room temperature. Thereafter the stock solution was treated with ultrasound for 15 min again.
- Eluate: Dilution water
- Differential loading: 10.0 - 20.0 - 40.0 - 80.0 - 160 mg/L
- Controls: Six replicates (without test item) were tested under the same test conditions as the test replicates.
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): 4 days
- Method of cultivation: Fresh stocks were prepared from Z-Agar. Light intensity amounted 35 - 70 µE x m-2 x s-1 for 24 h per day.
ACCLIMATION
- Culturing media and conditions (same as test or not): Same as test
- Any deformed or abnormal cells observed: No
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- Not measured
- Test temperature:
- Mean: 21.5 °C, Min: 21 °C, Max: 22 °C
- pH:
- Nominal test item concentration pH-value
[mg/L] Start; 0 hours End; 72 hours
160 7.65 7.79
80.0 7.64 7.86
40.0 7.69 8.02
20.0 7.72 8.11
10.0 7.71 8.20
Control 7.93 8.30 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater
- Nominal and measured concentrations:
- Please refer to "any other information on materials and methods incl. tables"
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Type (delete if not applicable): open
- 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: 4910 cells/mL
- Control end cells density: Mean 992333 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- No. of vessels per vehicle control (replicates): None
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dilution water, composition acc. to the guideline
- Hardness: 0.24 mmol Ca+Mg/L
- pH-value: 8.1 +/- 0.2
- Culture medium: Nutrient Medium Z acc. to LÜTTGE et al. (1994)
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 h
- Light intensity and quality: 60 - 120 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, via Chlorophyll-a fluorescence (excitation at 436 nm, emission at 685 nm), cell concentrations were related to all cell density values acc. to a calibration curve.
TEST CONCENTRATIONS
- Range finding study: Yes
Results of the Range Finding Test (0-72 h)
Results of the Range Finding Test (0-72 hours)
Nominal
Test Item Concentration
[mg/L] Specific Growth Rate Inhibition [%] Yield Inhibition [%]
100 33 80
10 - 1 - 5
1 3 12
0.1 2 11
0.01 3 13 - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 89.4 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: (81.2 - 98.9)
- 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: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50:
Rate-related inhibition: 0.488 (CI 0.466 - 0.512) mg/L
Yield Inhibition: 0.291 (CI 0.274 - 0.328) mg/L - Reported statistics and error estimates:
- EC10-, EC20- and EC50-values of the growth rate and yield inhibition after 72 hours were calculated by sigmoidal dose-response regression. Calculation of the confidence intervals. EC10-, EC20- and EC50-values were carried out using standard procedures.
Any other information on results incl. tables
NOEC, LOEC, EC - values and 95 % Confidence Intervals of Amino-C-Dion trocken
(0-72 hours)
based on nominal test item concentrations [mg/L]
Rate-related Inhibition |
|
NOEC |
20.0 |
LOEC |
40.0 |
ErC10 |
23.8 (19.8 – 28.5) |
ErC20 |
37.9 (33.0 – 42.6) |
ErC50 |
89.4 (81.2 – 98.9) |
Inhibition of Yield |
|
NOEC |
10.0 |
LOEC |
20.0 |
EyC10 |
12.8 ( 10.0 – 16.9) |
EyC20 |
17.5 (14.0 – 21.4) |
EyC50 |
29.5 (25.5 – 33.9) |
Cell Densities
|
Nominal test item concentration |
Replicate |
Cell density [cells/mL] |
||||||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
|
|||
160 |
1 |
4910 |
7736 |
10803 |
16419 |
|
|||
2 |
4910 |
9872 |
11923 |
21364 |
|
||||
3 |
4910 |
9181 |
12539 |
19079 |
|
||||
Mean |
4910 |
8930 |
11755 |
18954 |
|
||||
80.0 |
1 |
4910 |
14780 |
31966 |
90286 |
|
|||
2 |
4910 |
18013 |
41400 |
96416 |
|
||||
3 |
4910 |
17590 |
38614 |
88353 |
|
||||
Mean |
4910 |
16794 |
37327 |
91685 |
|
||||
40.0 |
1 |
4910 |
15609 |
59144 |
223371 |
|
|||
2 |
4910 |
17184 |
87707 |
389723 |
|
||||
3 |
4910 |
22038 |
87439 |
296500 |
|
||||
Mean |
4910 |
18277 |
78097 |
303198 |
|
||||
20.0 |
1 |
4910 |
16544 |
91840 |
610706 |
|
|||
2 |
4910 |
19042 |
112224 |
790517 |
|
||||
3 |
4910 |
21168 |
114008 |
812926 |
|
||||
Mean |
4910 |
18918 |
106024 |
738050 |
|
||||
10.0 |
1 |
4910 |
22901 |
110931 |
830460 |
|
|||
2 |
4910 |
20860 |
150630 |
1050925 |
|
||||
3 |
4910 |
21879 |
119810 |
919046 |
|
||||
Mean |
4910 |
21880 |
127124 |
933477 |
|
||||
Control |
1 |
4910 |
19181 |
138708 |
959696 |
|
|||
2 |
4910 |
21279 |
143112 |
974522 |
|
||||
3 |
4910 |
27914 |
147797 |
991718 |
|
||||
4 |
4910 |
19898 |
134569 |
984610 |
|
||||
5 |
4910 |
24224 |
163883 |
1073635 |
|
||||
6 |
4910 |
21530 |
132155 |
969817 |
|
||||
Mean |
4910 |
22338 |
143371 |
992333 |
|
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 |
Rate-related inhibition |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
160 |
1 |
0.402 |
77.3 |
11509 |
98.8 |
||
2 |
0.490 |
72.3 |
16454 |
98.3 |
|||
3 |
0.452 |
74.4 |
14169 |
98.6 |
|||
Mean |
(+) |
0.448 |
74.7 |
(+) |
14044 |
98.6 |
|
80.0 |
1 |
0.971 |
45.2 |
85376 |
91.4 |
||
2 |
0.992 |
43.9 |
91506 |
90.7 |
|||
3 |
0.963 |
45.6 |
83443 |
91.6 |
|||
Mean |
(+) |
0.975 |
44.9 |
(+) |
86775 |
91.2 |
|
40.0 |
1 |
1.27 |
28.1 |
218461 |
77.9 |
||
2 |
1.46 |
17.6 |
384813 |
61.0 |
|||
3 |
1.37 |
22.7 |
291590 |
70.5 |
|||
Mean |
(+) |
1.37 |
22.8 |
(+) |
298288 |
69.8 |
|
20.0 |
1 |
1.61 |
9.13 |
605796 |
38.7 |
||
2 |
1.69 |
4.27 |
785607 |
20.4 |
|||
3 |
1.70 |
3.74 |
808016 |
18.2 |
|||
Mean |
(+)* |
1.67 |
5.71 |
(+) |
733140 |
25.8 |
|
10.0 |
1 |
1.71 |
3.34 |
825550 |
16.4 |
||
2 |
1.79 |
-1.09 |
1046015 |
-5.93 |
|||
3 |
1.74 |
1.43 |
914136 |
7.42 |
|||
Mean |
(-) |
1.75 |
1.23 |
(-) |
928567 |
5.96 |
|
Control |
1 |
1.76 |
954786 |
||||
2 |
1.76 |
969612 |
|||||
3 |
1.77 |
986808 |
|||||
4 |
1.77 |
979700 |
|||||
5 |
1.80 |
1068725 |
|||||
6 |
1.76 |
964907 |
|||||
Mean |
1.77 |
987423 |
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 |
1.36 |
1.98 |
1.93 |
1.76 |
0.344 |
19.5 |
13.9 |
2 |
1.47 |
1.91 |
1.92 |
1.76 |
0.257 |
14.6 |
||
3 |
1.74 |
1.67 |
1.90 |
1.77 |
0.122 |
6.87 |
||
4 |
1.40 |
1.91 |
1.99 |
1.77 |
0.321 |
18.2 |
||
5 |
1.60 |
1.91 |
1.88 |
1.80 |
0.174 |
9.68 |
||
6 |
1.48 |
1.82 |
1.99 |
1.76 |
0.262 |
14.8 |
||
Mean |
1.77 |
|
||||||
SD ± |
0.01 |
|
||||||
CV [%] |
0.76 |
|
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study Amino-C-Dion trocken was found to inhibit the growth of the freshwater green alga Desmodesmus subspicatus after 72 hours. The NOEC-values for inhibition of specific growth rate and inhibition of yield after 72 hours were 20.0 mg/L and 10.0 mg/L, respectively. The LOEC-values for inhibition of specific growth rate and inhibition of yield after 72 hours were 40.0 mg/L and 20.0 mg/L, respectively. The EC50-values for inhibition of specific growth rate (ErC50) and yield (EyC50) with 95 % Confidence Intervals after 72 hours were 89.4 (81.2 – 98.9) and 29.5 (25.5 – 33.9) mg/L, respectively.
All effect levels are given based on nominal concentrations of Amino-C-Dion trocken. - Executive summary:
The toxicity of Amino-C-Dion trocken (batch number: 241)to the unicellular freshwater green alga Desmodesmus subspicatus was determined according to the principles of OECD 201 at Dr.U.Noack-Laboratorienin 31157 Sarstedt, Germany from September 13 to 16, 2011. 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 5 x 103 cells/mL. Based on a preliminary test 5 concentration levels were tested in a geometrical series with a dilution factor of 2, nominal: 10.0 - 20.0 - 40.0 - 80.0 - 160 mg/L. Three replicates were tested for each test item concentration and six replicates for the control. Environmental conditions were determined to be within the acceptable limits.
The concentrations of Amino-C-Dion trocken were analytically verified by HPLC-DAD at test start and test end of all test concentrations and the control. Details of the analytical method are presented in part 9. The analytical results are presented in Table 8.
The measured concentrations of Amino-C-Dion trocken at test start were in the range of 98 to 106 % and after 72 hours in the range of 80 to 106 % of the nominal values. Therefore, all effect values given are based on the nominal concentrations of the test item Amino-C-Dion trocken.NOEC, LOEC, EC - values and 95 % Confidence Intervals of Amino-C-Dion trocken
(0-72 hours)
based on nominal test item concentrations [mg/L]
Rate-related Inhibition
NOEC
20.0
LOEC
40.0
ErC10
23.8 (19.8 – 28.5)
ErC20
37.9 (33.0 – 42.6)
ErC50
89.4 (81.2 – 98.9)
Inhibition of Yield
NOEC
10.0
LOEC
20.0
EyC10
12.8 ( 10.0 – 16.9)
EyC20
17.5 (14.0 – 21.4)
EyC50
29.5 (25.5 – 33.9)
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