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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 24, 2017 to June 16, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TXEG
- Expiration date of the lot/batch: December 13, 2017
- Purity test date: December 13, 2016

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 20 +/- 5 degrees Celsius in the dark
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)

OTHER SPECIFICS:
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
The test medium of the highest test concentration of nominal 100 mg test item/L was prepared by dissolving 106.0 mg test item into1060 mL test water by intense stirring for 10 minutes. Adequate volumes of this test medium were diluted with test water to prepare the test media of the other desired test concentrations. The test media were prepared just before introduction of the daphnids (= start of the test).
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house cultures
- Feeding during test: none
- Food type: green algae, Desmodesmus subspicatus
- Amount:
- Frequency: at least five days/week

ACCLIMATION
- Acclimation period: none
- Acclimation conditions (same as test or not): same

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
2.5 mmol/L (250 mg/L) CaCO3
Test temperature:
19.8 to 20.5 degrees Celsius
pH:
7.9 to 8.4
Dissolved oxygen:
8.7 to 9.0 mg/L
Salinity:
not applicable
Conductivity:
< 5 uS/cm
Nominal and measured concentrations:
Nominal concentrations: 100, 45, 30.7, 9.4, and 4.3 mg/L and a control
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL glass beakers
- Type (delete if not applicable): open but covered with a lid
- Material, size, headspace, fill volume: 60 mL
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- Renewal rate of test solution (frequency/flow rate):
- 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
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water - Elendt M4
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Salinity:
- Culture medium different from test medium:
- Intervals of water quality measurement:

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes/no

RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
45.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight: no
- Other biological observations: immobility
- Mortality of control: 0
- Other adverse effects control: none
- Abnormal responses: none
Reported statistics and error estimates:
The 24-hour and 48-hour EC50, EC20 and EC10 and the 95 % confidence limits were calculated by probit analysis. The NOEC and LOEC after 24 and 48 hours were determined directly from the raw data. The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.
Validity criteria fulfilled:
yes
Conclusions:
No control mortality was observed. The 48-hr EC50 value was determined to be 45.5 mg/L with values for the NOEC and LOEC of 20.7 and 45.5 mg/L respectively.
Executive summary:

The toxic effect of the test item Eastman (TM) EEH Solvent to Daphnia magna was assessed in a static concentration-response test. The 48-hour NOEC was determined to be 20.7 mg test item/L. The 48-hour LOEC was determined to be 45.5 mg test item/L and the 48-hour EC50 value was calculated to be 45.50 mg test item/L. The quantification of the test item Eastman (TM) EEH Solvent in the test samples gas chromatography with flame ionization detection. At the start of the test 109% of the nominal test concentrations were found (average of the nominal concentrations of 100, 45.5 and 20.7 mg test item/L). After 48 hours test duration, 103% of the nominal value was determined (average of the nominal concentrations of 100, 45.5 and 20.7 mg test item/L). During the test the daphnids were exposed to a mean of 106% of nominal (average of the nominal concentrations of 100, 45.5 and 20.7 mg test item/L). The nominal concentrations of 9.4 and 4.3 mg test item/L were below the Limit of Quantification (LOQ). As these concentrations were below the 48-hours NOEC (see Table 1), dose verification was not required according to the study plan. Since the nominal concentrations of 100, 45.5 and 20.7 mg test item/L were within 100±20% recovery at test start and test end, all biological results were calculated based on nominal concentrations.

Description of key information

The toxic effect of the test item Eastman (TM) EEH Solvent to Daphnia magna was assessed in a static concentration-response test. The 48-hour NOEC was determined to be 20.7 mg test item/L. The 48 -hour LOEC was determined to be 45.5 mg test item/L and the 48-hour EC50 value was calculated to be 45.50 mg test item/L. All test concentrations were based on nominmal concentrations.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
45.5 mg/L

Additional information