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Ecotoxicological information

Short-term toxicity to fish

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short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-01-15 to 2016-02-19
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
according to guideline
EU Method C.1 (Acute Toxicity for Fish)
according to guideline
other: Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23, December 14, 2000
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Source and lot/batch No.of test material: M14KB4863
- Expiration date of the lot/batch: 2017-11-10 (retest date)
- Purity test date: 2014-11-11

- Storage condition of test material: At room temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: solubility in water: <0.01 g/L. The test samples were stored in the freezer (≤ -15°C). Storage stability of samples under these conditions was demonstrated in project 509941.
Analytical monitoring:
Details on sampling:
- Sampling method: singular samples for possible analysis were taken form all test concentrations with surviving fish and the control at t=0, t=24h and t=96h. Volume was 2.0 ml.
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 2.0 mL were taken for possible analysis
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to an expected low water solubility of the test item a saturated solution (SS) was prepared. The preparation of test solutions started with a loading rate of 100 mg/L applying two days of magnetic stirring at room temperature in the dark to ensure maximal dissolution of the test item in the test medium. The resulting aqueous mixture was filtered through a 0.45 µm membrane filter (Whatman; RC55) to remove any non-dissolved material. The filter was pre-conditioned with a small volume of test solution that was discarded. The resulting undiluted SS with the maximum concentration of dissolved test item was used as the highest test concentration. The final test solutions were all clear and colourless.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): final test solutions were clear and colourless
Test organisms (species):
Cyprinus carpio
Details on test organisms:
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): range-finding test: 2.8 ± 0.2 cm, limit test: 3.1 ± 0.2 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.28 ± 0.04 g, limit test 0.39 ± 0.09 g
- Feeding during test: no

- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): yes
- Type and amount of food: pelleted fish food
- Feeding frequency: daily
- Health during acclimation (any mortality observed): mortality less than 5% seven days before test
Test type:
Water media type:
Limit test:
Total exposure duration:
96 h
not indicated
Test temperature:
21 °C
Dissolved oxygen:
not relevant
not indicated
Nominal and measured concentrations:
Nominal concentrations: 100% of the SS prepared at 100 mg/L
Measured concentrations at t=0h: < 4 µg/L
Measured concentrations at t=24h: < 4 µg/L
Measured concentrations at t=96h: < 4 µg/L

Samples taken from 100% of the SS were analysed and showed that the actual test concentration was below the lowest calibration solution of 4 μg/L (taking a dilution factor of 2 into account) from the start of the test. The residue on the filter used for preparation of the highest test concentration was extracted. The extract was analysed after dilution. Based on the retention time, the residue was identified as test item indicating proper preparation of the test solution.
Details on test conditions:
- Test vessel: beaker
- Material, size, headspace, fill volume: 6.5L, all-glass filled with 6L test solution
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): not reported
- No. of vessels per control (replicates): not reported
- Biomass loading rate: 0.55 g fish/L

- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered to be dead when no reaction was observed after touching the caudal peduncle and visible breathing movements were absent.

- Spacing factor for test concentrations: none (limit test)
- Range finding study: yes
- Test concentrations: 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
Key result
96 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 100% v/v saturated solution, equivalent to a loading rate of 100 mg/L
Details on results:
- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50/LC50: 96-h LC50 = 0.24 mg/L.
Reported statistics and error estimates:
No LC50 could be calculated because the test item proved to be non-toxic. No statistical analysis was performed because of the lack of toxic effects
Validity criteria fulfilled:
The acute toxicity of T003063 to Carp was determined in a 96 hour static limit test according to the OECD guideline 203.
The 96h-LC50 was estimated to be above the solubility limit of the test item in test medium. Therefore, the highest concentration causing no mortality or effects to Carp were determined to be the loading rate of 100 mg/L (measured concentration of 0.4 µg/L). The 96h-LC50 was clearly higher than the loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.

Description of key information

The study of Bouwman (2016), investigating the acute toxicity of T003063 in carp according to OECD guideline 203, was considered as the key study for endpoint coverage. A LC50 > 100 mg/L (based on nominal test concentrations) was obtained after an exposure of 96 hours in a static test in freshwater. Therefore, the highest concentration causing no mortality or effects to Carp were determined to be the loading rate of 100 mg/L (measured concentration of < 0.4 µg/L).

Based on the results it can be considered that T003063 is not harmful to fish.

Key value for chemical safety assessment

Additional information