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Diss Factsheets

Ecotoxicological information

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:
26 - 29 Apr 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Councli Regulation (EC) No. 440/2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany (18 Nov 2014)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(2-phenylpropan-2-yl)phenyl 4-oxo-3-(λ⁵-diazynylidene)-3,4-dihydronaphthalene-1-sulfonate
Cas Number:
23121-00-8
Molecular formula:
C25H20N2O4S
IUPAC Name:
4-(2-phenylpropan-2-yl)phenyl 4-oxo-3-(λ⁵-diazynylidene)-3,4-dihydronaphthalene-1-sulfonate
Test material form:
solid

Sampling and analysis

Analytical monitoring:
no
Remarks:
The compound cannot be detected with standard analytical methods due to its low water solubility (0.073 mg/L, calculated with EPI Suite)

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock preparation with a test item concentration of 100 mg/L was freshly prepared. For that purpose, a calibrated flask with test item and vehicle was treated in an ultrasonic device for 1 h. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 h. Afterwards, the formulation was passed through a membrane filter with a pore size of 0.2 µm. The fitlrate was used for the study.
- Controls: Yes, consisting of reconstituted water without test substance.
- Evidence of undissolved material: The test medium was a clear preparation and stayed unchanged throughout the study.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Source: IBACON GmbH, Roßdorf, Germany
- Age of parental stock: Parental daphnids are used for reproduction until they are about 6 weeks old. Thereafter, they are replaced by neonates. The clone is bred in the laboratories of the testing facility.
- Age of daphnids at test start: < 24 h old
- Culture conditions: Daphnia are kept individually in 100 mL glass vessels containing approximately 60 mL reconstituted water (ELENDT M4 medium) at a water temperature of 20 ± 2 °C and a 16 h light and 8 h dark regime to ensure similar conditions as in the experiment. Offspring are removed from the vessels at least twice per week.
- Feeding during test: No feeding during the test.
- Food type: Unicellular green algae Desmodesmus subspicatus
- Frequency: The parental daphnids are fed ad libitum three times per week.


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Before start of the experimental phase, the young daphnids were separated from their parent animals and transferred into a test vessel containing reconstituted water. The daphnids were visually inspected for motility. If daphnids did not make any swimming movements within 15 s after their test vessels had been gently agitated, they were considered to be immobile and were not used for the study. At the start of the experimental phase the daphnids were cautiously removed using a pipette, separted from the reconstituted water using a fine-mesh sieve, and transferred into the test vessels containing test media (test item group) or reconstituted water (control group). The daphnids were randomly allocated to the different groups.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Test temperature:
19.3 - 20.1 °C
pH:
7.75 - 7.82
Dissolved oxygen:
Control: 8.18 mg O2/L (0 h), 8.07 mg O2/L (48 h)
Treatment: 5.63 mg O2/L (0 h), 7.72 mg O2/L (48 h)
Nominal and measured concentrations:
Control and 100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel: tubes
- Type: open
- Material, size, headspace, fill volume: 20 mL glass tubes filled with 20 mL (4 mL per daphnid)
- Aeration: No aeration during exposure.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Fully demineralized water (Milli-Q Water Purification System, Merck Millipore, Darmstdt, Germany)
- Culture medium different from test medium: Culture medium same as test medium (reconstituted water: Elendt M4).
- Intervals of water quality measurement: pH and oxygen concentration of the test media were measured at the start and at the end of the exposure period. At the beginning of exposure, separate beakers, one for each test group but without dapnids, were used for the measurments. For the measurements at the end of the exposure period, the test media of each test group were pooled prior to measurement. The water temperature was measured in a separate vessel containing fully demineralized water only, kept under the same experimental conditions. The data were recorded using MCPS.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light/8 h dark
- Light intensity: 599 lux (prior test) and 611 lux (at test end)

EFFECT PARAMETERS MEASURED:
Immobilization: Recorded after 24 and 48 h.

RANGE-FINDING STUDY
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: In a pre-test no immobilization was observed at a concentration of 100 mg/L under open static conditions. Therefore, the solution of a nominal test item concentration of 100 mg/L was tested in the present study.
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.073 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
Value refers to max. water solubility calculated with EPI Suite.
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: No
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test medium was a clear preparation and stayed unchanged throughout the study.
Results with reference substance (positive control):
- Results with reference substance valid? Yes, results of the reference substance (20 - 22 Oct 2015) were within the required range defined by the guideline.
- Relevant effect levels: EC50 (48 h) = 0.602 mg/L Potassium dichromate, 95% confidence interval: 0.525 - 0.689 mg/L

Any other information on results incl. tables

Under the conditions of the present study, an aqueous solution of nominal 100 mg/L of test substance revealed no aquatic toxicity in the test system.

The EC50 (48 h) was > 0.073 mg/L (nominal > 100 mg/L) and, thus, could not be determined in this study.

The value 0.073mg/L corresponds to the calculated water solubility (EPI Suite).

Applicant's summary and conclusion