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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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-09-13 to 2011-09-15
- 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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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
- Analytical purity: 93.8 % (w/w)
- 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 active ingredient 2,3-Quinoxalinedione, 6-amino-1,4-dihydro-7-methoxy- of the test item Amino-C-Dion trocken was analytically verified by HPLC-DAD in the fresh media (0 h) and old media (48 h) in all concentration levels and the control.
- Sampling method: For the old media, separate replicates without test organisms were prepared and incubated under test conditions.
- 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 40 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: 1.25 - 2.50 - 5.00 - 10.0 - 20.0 - 40.0 mg/L (dilution factor 2)
- Controls: Dilution water without test item tested under the same conditions as the test groups.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- Lufthygiene (WaBoLu), further own breeding
- Age at study initiation (mean and range, SD): 2 to 24 h
- Method of breeding: In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20+/- 2 °C, in an incubator, 16 h illumination, illumination strength max. 20 µE*m-2*s-1. Culture medium: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L. Culture Feeding: At least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata, Desmodesmus subspicatus and Chlorella vulgaris, with an algae cell density of > 106 cells/mL.
- Feeding during test: No feeding
ACCLIMATION
- Acclimation period: 2 h
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: No feeding
- Health during acclimation (any mortality observed): Healthy, no mortality observed
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- No
Test conditions
- Hardness:
- Dilution water: 1262 (mg CaCO3/L)
- Test temperature:
- 20.6 °C.
- pH:
- Water Quality Parameters at Test Start (0 h, Fresh Media)
(measured in one replicate per concentration level and control)
Nominal
Test Item
Concentration
[mg/L] pH-Value
40.0 7.77
20.0 7.87
10.0 7.90
5.00 7.88
2.50 7.85
1.25 7.89
Control 7.95
Water Quality Parameters at Test End (48 h, Old Media)
(measured in all replicates)
Nominal
Test Item
Concentration
[mg/L] pH-Values
Replicates
1 2 3 4
40.0 7.72 7.75 7.74 7.69
20.0 7.70 7.67 7.71 7.64
10.0 7.63 7.67 7.70 7.72
5.00 7.67 7.59 7.53 7.55
2.50 7.65 7.60 7.60 7.58
1.25 7.62 7.65 7.63 7.65
Control 7.62 7.69 7.71 7.66 - Dissolved oxygen:
- Water Quality Parameters at Test Start (0 h, Fresh Media)
(measured in one replicate per concentration level and control)
Nominal
Test Item
Concentration
[mg/L] Dissolved
O2-Concentration
[mg/L]
40.0 7.99
20.0 8.41
10.0 8.54
5.00 8.65
2.50 8.66
1.25 8.53
Control 8.93
Water Quality Parameters at Test End (48 h, Old Media)
(measured in all replicates)
Nominal
Test Item
Concentration
[mg/L] Dissolved O2 -Concentration [mg/L]
Replicates
1 2 3 4
40.0 8.44 8.47 8.41 8.39
20.0 8.43 8.28 8.37 8.43
10.0 8.44 8.49 8.44 8.37
5.00 8.46 8.30 8.43 8.40
2.50 8.51 8.52 8.50 8.52
1.25 8.52 8.49 8.50 8.44
Control 8.76 8.62 8.44 8.88 - Salinity:
- Freshwater
- Nominal and measured concentrations:
- Please refer to "Any other information on materials and methods"
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers, 50 mL
- Material, size, headspace, fill volume: Glass beakers (4 cm ID x 7 cm H), 50 mL
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): One application at test start, static test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): None
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
ISO Test water, according to OECD 202, Annex 3
Component Concentration [mg/L]
KCl 5.76
NaHCO3 64.8
CaCl2 2 H2O 294
MgSO4 7 H2O 123
pH-value: 7.8 0.2
- Culture medium different from test medium: No
- Intervals of water quality measurement: At test start and test end
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16:8 light:dark cycle
- Light intensity: Diffuse light, illumination strength max. 20 µE x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
IImmobility was determined in all groups after 24 and 48 h. An animal was considered to be immobile, if it was not able to swim within 15 sec after gentle agitation of the test vessel.
TEST CONCENTRATIONS
- Range finding study:
A non GLP preliminary range finding test was conducted under static conditions with three nominal test item concentrations ranging from 1 to 100 mg/L set up in a geometric series with a dilution factor of 10. The percentage immobility was determined in all test item and control groups after 24 and 48 h of exposure.
Immobilization Rates of the non GLP Preliminary Test
(n = 20, divided into 2 replicates with 10 daphnids each)
Nominal
test item
concentration
[mg/L] IMMOBILIZATION [%]
24 h 48 h
Replicates Replicates
1 2 MV 1 2 MV
100 60 80 70 90 100 95
10 40 30 35 80 80 80
1 0 0 0 0 0 0
Control 0 0 0 0 0 0 - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8.02 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (7.06 - 8.93)
- Details on results:
- - Behavioural abnormalities: None
- Mortality of control: 0%
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
EC50 : 1.70 mg/L (CI 1.59 - 1.86 mg/L) - Reported statistics and error estimates:
- EC10- and the EC50-values were calculated by sigmoidal dose-response regression. The confidence intervals for the EC50-values were calculated from the best-fit values, the standard error and the t-distribution with the software GraphPad prism. The concentration effect relationships are shown graphically.
Any other information on results incl. tables
Immobilization Rates of the Definitive Testafter 24 and 48 h of Exposure
(n = 20, divided into 4 replicates with 5 daphnids each)
IMMOBILIZATION [%] |
||||||||||
Amino-C-Dion trocken Nominal Test Item Concentration [mg/L] |
24 h |
48 h |
||||||||
Replicates |
Replicates |
|||||||||
1. |
2. |
3. |
4. |
MV |
1. |
2. |
3. |
4. |
MV |
|
40.0 |
80 |
80 |
80 |
80 |
80 |
100 |
100 |
80 |
80 |
90 |
20.0 |
80 |
100 |
80 |
80 |
85 |
80 |
100 |
80 |
80 |
85 |
10.0 |
60 |
40 |
80 |
60 |
60 |
80 |
60 |
80 |
60 |
70 |
5.00 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
20 |
10 |
2.50 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the nominal concentrations of the test item Amino-C-Dion trocken the 48-h EC50 for Daphnia magna was estimated to be 8.02 mg/L (95 % confidence limits: 7.06 – 8.93 mg/L).
The NOEC after 48 h was determined to be 5.00 mg/L as the highest tested concentration with no biologically significant effect (Immobilization rates of <10 % are seen to be not significant according to the guideline). The LOEC after 48 h was determined to be 10.0 mg/L as the lowest tested concentration with a biologically significant effect (Immobilization rates of > 10 % are seen to be significant according to the guideline). - Executive summary:
In the acute immobilization test with Daphnia magna (STRAUS) the effects of the test item Amino-C-Dion trocken (batch number: 241) were determined according to OECD 202 (2004) from 2011-09-13 to 2011-09-15 at Dr.U.Noack-Laboratorien, Käthe-Paulus-Str.1, 31157 Sarstedt, Germany .
The study was conducted under static conditions over a period of 48 h with 5nominal test item concentrations ranging from 1.25 to 40.0 mg/L set up in a geometric series with a dilution factor of 2. 20 test organisms were exposed to each test concentration and control.
All test concentrations and control were analytically verified via HPLC-DAD after 0 h (fresh media) and 48 h (old media).
The recoveries of the test item Amino-C-Dion trocken were determined to be in the range of 93 to 105 % of the nominal values in the fresh media (0 h) and old media (48 h) in all concentration levels, demonstrating that the concentrations of test item Amino-C-Dion trocken were successfully maintained for the duration of the test.All effect values, presented in Table 1, are based on the nominal concentrations of the test item Amino-C-Dion trocken.
The water quality parameters (pH-value and dissolved oxygen concentration), measured at 0 and 48 h, were determined to be within the acceptable limits. The validity criteria of the test guideline were fulfilled.
Table 1: EC10-, EC50- (with Confidence Interval), EC100 - Values, NOEC and LOEC
(based on the nominal concentrations of the test item Amino-C-Dion trocken)
Test Duration
[h]Nominal Concentration
of the Test Item Amino-C-Dion trocken
[mg/L]Confidence Interval
p = 95%
[mg/L]EC10
24
4.89
4.10 – 5.74
48
4.98
4.10 – 6.13
EC50
24
9.38
8.18 – 10.6
48
8.02
7.06 – 8.93
EC100
24
> 40.0
---
48
> 40.0
---
NOEC
48
5.00
---
LOEC
48
10.0
---
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