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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:
2017-05-14 to 2017-06-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
See section 'Any other information on materials and methods incl. tables'
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
- Analytical purity: 96.3% (based on chromatographic purity GC)
- Source and lot/batch No.of test material: A16EB1463
- Expiration date of the lot/batch: 12 September 2017 (retest date)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- 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: 0.2 g/L


Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples for possible analysis were taken from all test concentrations and the control. At the start and the end of both 48-hour renewal periods from test concentrations with surviving fish. Otherwise test concentrations were sampled as soon as all fish were found dead. Volume was 2.0 mL from the approximate centre of the test vessels.
- 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 and its degradation products, a saturated solution (SS) was prepared. The preparation of test solutions started with a loading rate of 100 mg/L applying one day of magnetic stirring at room temperature to ensure full degradation of the test item to its metabolites. The obtained aqueous mixture was left to stabilize for approximately 15 minutes where after the SS was taken out by siphoning. The SS was used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- 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: 3.9 ± 0.1 cm, limit test: 2.9 ± 0.3 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.98 ± 0.15 g, limit test 0.37 ± 0.13 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:
yes
Total exposure duration:
96 h
Hardness:
not reported
Test temperature:
20-24°C
pH:
7.2 - 7.8
Dissolved oxygen:
6.9-8.9
Salinity:
not relevant
Conductivity:
not indicated
Nominal and measured concentrations:
Range-finder:
Nominal concentrations: 10% and 100% of SS (1% of SS not analysed)
Measured concentrations at t=0h: 8.59 and 89.1 mg/L
Measured concentrations at t=96h: 4.09 and 55.9 mg/L

Final test:
Nominal concentrations: 10, 18, 32, 56 and 100% SS at 100 mg/L
Mean Measured concentrations at t=0h: 9.2, 17, 30, 55, 97 mg/L
Measured concentrations at t=24h: -, -, 30.7, 52.9, - mg/L
Measured concentrations at t=48h (old): 8.45, 15.7, -, -, - mg/L
Measured concentrations at t=48h (fresh): 8.89, -, -, -, 88.1 mg/L
Measured concentrations at t=96h: 7.95, -, -, -, - mg/L

- not measured
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 6.5 L, all-glass filled with 6 L 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: 0.32 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: none (limit test)
- Range finding study: yes
- Test concentrations: 1%, 10% and 100% of a saturated solution (corresponding to a nominal loading rate 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.:
12 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: none
- Other adverse effects control: no


Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50/LC50: 96-h LC50 = 0.32 mg/L.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T000749 to carp 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 12 mg/L based on initial exposure concentrations (95% confidence interval between 7.1 and 16 mg/L) and was already reached after 48 hours of exposure. The results of the test can be considered reliable without restriction.

Description of key information

Based on an OECD 203 guideline study (Bouwman, 2017) in which the acute toxicity of T000749 to carp was determined in a 96-hour semi-static test, the 96-h LC50 was 12 mg/L based on initial exposure concentrations (95% confidence interval between 7.1 and 16 mg/L). This toxicity was already reached after 48 hours of exposure. The results of the test can be considered reliable without restriction.

Key value for chemical safety assessment

LC50 for freshwater fish:
12 mg/L

Additional information