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Ecotoxicological information

Short-term toxicity to fish

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 24, 2017 to June 27, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity 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
Details on sampling:
- Concentrations: all test concentrations and the water control
- Sampling method: one sample from the test medial of all test concentrations and the control were collected at the end of the test (after 96 hours) from the approximate center of the aquaria
- Sample storage conditions before analysis:
Vehicle:
no
Details on test solutions:
A stock solution of 1000 mg test item/L was prepared by dissolving 2000.2 mg test item into 2000.2 mL test water by intense stirring for 40 minutes and ultrasonic treatment for 5 minutes. Adequate volumes of this stock solution were diluted with test water to prepare the test media of the desired test concentrations.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow Trout
- Strain:
- Source: Forellenzuchtbetrieb Stork, 88348 Bad Saulgau, Germany
- Age at study initiation (mean and range, SD): juveniles,
- Length at study initiation (length definition, mean, range and SD): 4.65 cm +/- 0.3 cm
- Weight at study initiation (mean and range, SD): 0.88 g +/- 0.1 g
- Method of breeding:
- Maintenance of the brood fish:

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation:
- Feeding frequency during acclimation: 3x per week
- Health during acclimation (any mortality observed): mortality below 5%

QUARANTINE (wild caught)
- Duration:
- Health/mortality:

FEEDING DURING TEST
- Food type:
- Amount:
- Frequency:
Test type:
static
Water media type:
freshwater
Remarks:
reconstituted water (ISO Method)
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
25 mmol/L (250 mg/L) as CaCO3
Test temperature:
15 to 15 degrees Celsius
pH:
7.8 to 8.0
Dissolved oxygen:
98 to 101% of air saturation
Salinity:
not applicable
Conductivity:
Nominal and measured concentrations:
Nominal test concetrations: 100, 45.5, 20.7, 9.4 and 4.3 mg test item/L and a control
Details on test conditions:
TEST SYSTEM
- Test vessel: 12 litre glass aquaria
- Material, size, headspace, fill volume: 10 kitre test medium
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: < 1g fish/L water

- Range finding study : yes
- Test concentrations: 100, 45.5, 20.7, 9.4, and 4.3 mg/L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
67.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
no abnormal behaviors were observed and no mortality was reported in the control
Reported statistics and error estimates:
The LC50, LC20 and LC10 at the observation times were calculated by Probit analysis. The NOEC, the LOEC, the LC0 and the LC100 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 mortality was seen in the control vessel. The 96-hour LC50 value was determined to be 67.3 mg/L, with a no observed effect concentration at 20.7 mg/L.
Executive summary:

The toxic effect of the test item Eastman ™ EEH Solvent to Rainbow Trout (Oncorhynchus mykiss) was assessed in a static concentration response test. Based on the test results the 96-hour LC50 was determined to be 67.3 mg test item/L based on nominal concentrations. The NOEC was determined to be 20.7 mg test item/L also based on nominal concentrations. The quantification of the test item Eastman ™ EEH Solvent in the test samples was performed using gas chromatography with flame ionization detection. At the start of the test 90% of the nominal test concentrations were found (average of the nominal concentrations of 100, 45.5 and 20.7 mg test item/L). After 96 hours test duration, 93% 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 fish were exposed to a mean of 92% of nominal. 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 96-hour NOEC, 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 ™ EEH Solvent to Rainbow Trout (Oncorhynchus mykiss) was assessed in a static concentration response test. Based on the test results the 96-hour LC50 was determined to be 67.3 mg test item/L based on nominal concentrations. The NOEC was determined to be 20.7 mg test item/L also based on nominal concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
67.3 mg/L

Additional information