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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:
10 February 2017 - 14 April 2017
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
Guideline:
other: Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23
Version / remarks:
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:101.1% (based on assay)
- Source and lot/batch No.of test material: M16FB2273
- Expiration date of the lot/batch: 14 June 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: <0.1 g/L


Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples for possible analysis were taken from all test concentrations and the control at t=0, 24 and 96 hours from test concentrations with surviving fish. The volume used in sampling was 36 mL and was retrieved from the approximate centre of the test vessels. On the day of sampling, 36 mL samples were extracted with 1.5 mL n-hexane, shaken for 30 seconds and analysed.
- Sample storage conditions before analysis: not applicable since samples were analysed on the day of sampling.
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 which started with a loading rate of 100 mg/L applying 3 days of magnetic stirring at room temperature to ensure maximum dissolution of the test item in test medium. This resulted in a clear and colourless dispersion that contained undissolved material. Lower test concentrations for the range-finding test 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: Range-finding test: 3.4 ± 0.4 cm Final test: 3.8 ± 0.2 cm
- Weight at study initiation (mean and range, SD): Range-finding test: 0.62 ± 0.25 g Final test: 0.59 ± 0.12 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:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre
Test temperature:
20-24°C
pH:
7.7 ± 0.3
Dissolved oxygen:
oxygen > 60% of air saturation ????
Salinity:
not relevant (fresh water)
Conductivity:
not reported
Nominal and measured concentrations:
Range-finder:
Nominal concentrations: 1%, 10% and 100% of SS at 100 mg/L
Measured concentrations at t=0h: n.d., 0.00284, 0.0190 mg/L
Measured concentrations at t=96h: n.d, n.d, n.d

Final test:
Nominal concentrations: 0 and 100% SS at 100 mg/L
Mean Measured concentrations at t=0h: n.d. and 0.0324 mg/L
Measured concentrations at t=96h: n.d. n.d.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass vessels
- Material, size, headspace, fill volume: 10L however filled up with 9.8L of test solution
- Aeration: after 48 hours of exposure
- 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: 0.42 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.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: after 96h measured test concentrations were below the limit of detection
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:
Based on the results obtained during the guideline Carp study on the test item, JNJ-42808389-AAA (T003421), the 96-h LC50 was beyond the range tested, i.e. exceeded an average exposure concentration of 0.067 mg/L, corresponding to a loading rate of 100 mg/L.
In conclusion, the test substance had no significant toxic effect on Carp after an exposure of 96 hours up to and including the highest loading rate of 100 mg/L.

Description of key information

In the results obtained during the guideline Carp study (Tobor-Kaplon, 2017) on the test item, JNJ-42808389-AAA (T003421), the 96-h LC50 was beyond the range tested, i.e. exceeded an average exposure concentration of 0.067 mg/L, corresponding to a loading rate of 100 mg/L. Results of this study are reliable without restrictions.

Key value for chemical safety assessment

Additional information