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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:
2007-09-10 to 2008-03-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
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: 00512242
- Expiration date of the lot/batch: 2013-06-27 (retest date)
- Purity test date: 2007-08-21 (certificate of analysis release date)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: cool, dry, tighly closed
- Stability under test conditions: stability in test solutions was verified by analytical determinations
Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples were taken at 0h, from fresh test solution and after 24,48 and 72h from aged and fresh test solution and after 96 hours from aged test solution.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substance):
A stock solution containing 1000 µg/mL of the test item was prepared by weighting 20.2 mg of the test item into a 20 mL volumetric flask and adjusting the volume to 20.2 mL with acetonitrile. From the stock solutions, dilutions containing 10 µg/mL and 1 µg/mL were prepared in acetonitrile. From the 1 µg/mL dilution, a dilution containing 0.1 µg/mL was prepared in acetonitrile/water 2:10 (v/v) and used for preparation of calibration curve. All solutions were stored refrigerated.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Fischzucht Wagenhause, Germany
- Length at study initiation (length definition, mean, range and SD): 4-6 cm
- Feeding during test: feeding was stopped 24 h before initiation of test

ACCLIMATION
- Acclimation period: >12 days
- Acclimation conditions (same as test or not): testing conditions in 300 L containers with continuous renewal of water (5-10% per day) and permanent aeration of water.
- the fish were fed each day with granular rearing food with approximately 2% of their bodyweight.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
14°dH
Test temperature:
15.4-16.8°C
pH:
7.88-8.5
Dissolved oxygen:
>91% of air saturation (approximately 9.1 mg O2/L)
Conductivity:
467 µS/cm
Nominal and measured concentrations:
Range-finder:
Nominal concentrations (mg/L): 0, 0.01, 0.1, 1, 10, 100

Final test
nominal concentrations (mg/L): 0, (1.563), (3.125), 6.25, 12.5, 25, 50, (100) - () not analysed
t=0h (mg/L): < LOQ, 3.20, 8.88, -, 34.80
t=24h aged: t=24h fresh: t=48h aged: t=48h fresh: t=72h aged: t=72h fresh: t=96h aged:
Details on test conditions:
TEST SYSTEM
- Test vessel: 25L stainless steel tanks, filled with 24L
- No. of organisms per vessel: 10 per concentration
- No. of vessels per concentration (replicates): no replicates
- Biomass loading rate: max loading of 1g fish/L

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortaility, clinical signs was checked at 3h,6h,24h,48h,72h,96h.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: x2
- Range finding study: yes
- Test concentrations:0-0.01-1-10-100 mg/L
- Results used to determine the conditions for the definitive study: In the nominal concentrations up to 10 mg/L no fish died, but at the nominal concentration of 100 mg/L all fish died within a period of 24 hours.
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
28.06 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: C.L.: 19.087-41.251 mg/L
Details on results:
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: unusual behaviour (reduced activity, change in pigmentation and or orientation to bottom or surface of the test vessels), difficulties with maintenance of equilibrium
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- LC0 (96h) was observed at 6.25 mg/L
- LC100 (96h) was observed at 50 mg/L.
- LC50 (24h)= 84.08 mg/L (CL: 56.114-125.976)
- LC50 (48h)=34.02 mg/L (CL: 30.630-37.779)
- LC50 (72h) = 32.42 mg/L (CL: 19.087-41.251)
- NOEC = 6.25 mg/L
Reported statistics and error estimates:
Due to the distribution of the data, the LC50 was calculated using the Moving Average Computations.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T000824 to Rainbow trout was determined in a 96-hour semi-static test according to OECD guideline 203. Under the conditions of the present study, the 96-h LC50 was determined to be 28.06 mg/L, whereas the NOEC was 6.25 mg/L (nominal concentrations). The results of the test can be considered reliable without restriction.

Description of key information

The study of Gonsior (2008), investigating the acute toxicity of T000824 in rainbow trout according to OECD guideline 203, was considered as the key study for endpoint coverage. An LC50 of 28.06 mg/L (based on nominal test concentrations) was obtained after an exposure of 96 hours in a semi-static test in freshwater. Based on the results it can be considered that T000824 is harmful to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
28.06 mg/L

Additional information

One key study (Klimisch sore of 1) was available on the acute toxicity of T000824 to Rainbow trout. The key study exposed Rainbow trout for 96 hours to T000824 under semi-static conditions. The nominal test item concentrations were

1.563, 3.125, 6.25, 12.5, 25, 50, 100 mg/L and in parallel the control. Based on the nominal test concentrations a 96 -h LC50 of 28.06 mg/L for T000824.

Based on the results it can be considered that T000824 is harmful to fish.