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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:
2016-04-01 to 2016-05-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
Guideline:
other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: I15FC2164
- Expiration date of the lot/batch: 2017-06-23 (retest date)
- Purity test date: 2015-07-01

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: Not indicated
- Solubility and stability of the test substance in the solvent/vehicle: Not indicated
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not indicated
Analytical monitoring:
yes
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
Vehicle:
no
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, Saturated Solutions (SS) were 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 maximum dissolution of the test item in the test medium. The obtained hazy dispersion containing undissolved floating material and precipitate was filtered through a membrane filter (Whatman; RC55). The filter was pre-conditioned with a small volume of test solution that was discarded. The resulting SS was used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All final test solutions were 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:
TEST ORGANISM
- 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: 3.4 ± 0.5 cm, final test: 2.9 ± 0.3 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.55 ± 0.22 g, limit test 0.32 ± 0.08 g
- Feeding during test: no

ACCLIMATION
- 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:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
not reported
Test temperature:
21.3-22.5 °C
pH:
7.6-8.0
Dissolved oxygen:
7.1-9.2
Salinity:
not relevant
Conductivity:
not indicated
Nominal and measured concentrations:
Combined limit/range-finder test:
The actual concentration was 0.97 mg/L at the start of the exposure. The measure concentration decreased to 55% of initial at the end of the exposure. Because of the instability of test concentrations, it was decided to perform the full test with a daily renewal of test solutions.

Final test:
Nominal concentrations: 0, 10, 18, 32, 56 and 100% SS prepared at 100 mg/L
Measured concentrations at t=0h (fresh): n.d., 0.103, 0.193, 0.343, 0.595, 1.06 mg/L
Measured concentrations at t=24h (old): n.d., 0.093, 0.181, 0.305, 0.535, 0.927 mg/L
Measured concentrations at t=72h (fresh): n.d., 0.102, 0.185, 0.323, 0.580, 1.03 mg/L
Measured concentrations at t=96h (old): n.d., 0.0978, 0.169, 0.297, 0.520, 0.882 mg/L

Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 6L, all-glass filled with 5L 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: 0.45 g fish/L

OTHER TEST CONDITIONS
- 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.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- 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):
yes
Remarks:
pentachlorophenol
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
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 observed effects were below 50% (LC50 > maximum concentration tested).
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T0002488 to Carp was determined in a 96 hour static limit test according to the OECD guideline 203. Under the conditions of the performed study the 96-h LC50 was beyond the range tested, i.e. exceeded the average exposure concentration of 0.97 mg/L, being considered the maximum soluble in test medium. Therefore, the highest concentration causing no effects to fish was determined to be the loading rate of 100 mg/L. The 96-h 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 acute toxicity of T002488 to Carp was determined in a 96 hour static limit test according to the OECD guideline 203 (Tobor-Kaplon, 2016). Under the conditions of the performed study the 96-h LC50 was beyond the range tested, i.e. exceeded the average exposure concentration of 0.97 mg/L, being considered the maximum soluble in test medium. Therefore, the highest concentration causing no effects to fish was determined to be the loading rate of 100 mg/L. The 96-h LC50 was clearly higher than the loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.

Key value for chemical safety assessment

Additional information