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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study. All relevant validity criteria were met with acceptable deviations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
No positive control conducted as part of the study.
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
No positive control conducted as part of the study.
GLP compliance:
not specified
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 (control), to 1000 mg/L
Time Weighted Mean Measured equivalent concentrations:
- Sampling method: Water samples were taken from the control and all surviving test groups at 0 (fresh media); 24, 48, 72 (old and fresh media) and 96 (old media) hours for quantitative analysis. Samples were prepared for analysis on the day of sampling.
- Sample storage conditions before analysis: See above.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct dissolution of test item in DMSO to prepare stock; serial dilution of stock in culture medium to prepare test media. The test concentrations used in the definitive study were prepared by adding an amount of test item to the vortex created in a volume of water to give an initial dispersion at a concentration of 1000 mg/L. Stirring periods of 24 hours and 96 hours were employed and samples taken for chemical analysis. Based on the results of the range-finding study the test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in culture medium.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): DMSO used due to low solubility of test item in aqueous solution.
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No precipitate reported.
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Japanese Medaka / Japanese Rice Fish (Oryzias latipes)
- Strain: Not reported.
- Source: Recognised supplier.
- Age at study initiation (mean and range, SD): Not reported.
- Length at study initiation (length definition, mean, range and SD): 2.0 cm
- Weight at study initiation (mean and range, SD): 0.2 g
- Method of breeding: Not reported.
- Maintenance of the brood fish: Not reported.

ACCLIMATION
- Acclimation period: 15 days.
- Acclimation conditions (same as test or not): Yes.
- Type and amount of food during acclimation: Not reported.
- Feeding frequency during acclimation: daily (until 24 hours prior to test).
- Health during acclimation (any mortality observed): No mortality reported prior to test.

QUARANTINE (wild caught)
- Duration: Not applicable.
- Health/mortality: Not applicable.

FEEDING DURING TEST
- Food type: Not applicable.
- Amount: Not applicable.
- Frequency: Not applicable.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Remarks on exposure duration:
According to OECD TG 203 guidelines.
Post exposure observation period:
none.
Hardness:
ca. 50-70 mg/L (expressed as CaCO3)
Test temperature:
25 +/- 1 ºC
pH:
7.7 - 7.8 (fresh media)
Dissolved oxygen:
Not reported.
Salinity:
not applicable.
Nominal and measured concentrations:
Concentrations: 0 (control), to 1000 mg/L analytically confirmed initial concentration.
Details on test conditions:
TEST SYSTEM
- Test vessel: 15 L for test and control vessels, supplied by Tetra Werke.
- Type (delete if not applicable): Not specified.
- Material, size, headspace, fill volume: 15L fill volume test media per test vessel
- Aeration: Not specified.
- Renewal rate of test solution (frequency): 24 h
- No. of organisms per vessel: 10
- 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: Not specified.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory water supply.
- Total organic carbon: Not reported
- Particulate matter: Not reported
- Metals: Not reported
- Pesticides: Not reported
- Chlorine: Not reported
- Alkalinity: Not reported
- Ca/mg ratio: Not reported
- Conductivity: Not reported
- Culture medium different from test medium: No.
- Intervals of water quality measurement: 24 hours.

OTHER TEST CONDITIONS
- Adjustment of pH: No.
- Photoperiod: 16 h light / 8 h darkness
- Light intensity: 1500 lux.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and visible abnormality recorded at 3 h, 24 h, 48 h, 72 h and 96 h.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable. Concentrations justified from the results of the range finding study.
- Range finding study: yes (semi-static) ; 3 organisms per concentration.
- Test concentrations: blank control, 0-1000 mg/L nominal
- Results used to determine the conditions for the definitive study: Yes.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4.9 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: (95% CI: 3.7 - 6.6 mg/L) ; time weighted mean measured concentrations
Details on results:
- Behavioural abnormalities: Not reported.
- Observations on body length and weight: Not reported
- Other biological observations: Not reported
- Mortality of control: 0%
- Other adverse effects control: No abnormalities observed in the control.
- Abnormal responses: Not reported.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Not reported.
- Effect concentrations exceeding solubility of substance in test medium: Not applicable
Validity criteria fulfilled:
yes
Conclusions:
The 96 hour LC50 for the test item to Japanese Medaka (Oryzias latipes) was determined to be 4.9 (C.I. 3.7 - 6.6) mg/L based on time weighted mean measured concentrations.
Executive summary:

The acute toxicity of the test item to Japanese Medaka (Oryzias latipes) was determined in a 96 hour semi-static test according to OECD TG 203, equivalent to EU Method C.1 guidelines. Following a preliminary range-finding test, fish were exposed, in groups often, to an aqueous solution of the test item at time-weighted mean measured test concentrations of 0 -1000 mg/L for a period of 96 hours under semi-static test conditions. Based on the results of the range-finding study the test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in culture medium for a period of time, to produce the test concentrations. The effect levels were estimated based on time weighted mean measured concentrations. Under the conditions of this study, the 96h LC50 was 4.9 (C.I. 3.7 – 6.6) mg/L based on time weighted mean measured concentrations.

Description of key information

LC50 (fish) = 4.9 (C.I. 3.7 – 6.6) mg/L based on time weighted mean measured concentrations, 96hour, freshwater, OECD TG 203, 1988

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
4.9 mg/L

Additional information

Key study : OECD TG 201, 2000 : The acute toxicity of the test item to Japanese Medaka (Oryzias latipes) was determined in a 96 hour semi-static test according to OECD TG 203, equivalent to EU Method C.1 guidelines. Following a preliminary range-finding test, fish were exposed, in groups often, to an aqueous solution of the test item at time-weighted mean measured test concentrations of 0 -1000 mg/L for a period of 96 hours under semi-static test conditions. Based on the results of the range-finding study the test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in culture medium for a period of time, to produce the test concentrations. The effect levels were estimated based on time weighted mean measured concentrations. Under the conditions of this study, the 96h LC50 was 4.9 (C.I. 3.7 – 6.6) mg/L based on time weighted mean measured concentrations.