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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:
2017-10-06 to 2017-11-09
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 items 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: >99.8% (based on chromatographic purity GC: 99.8%, assay Cl-Schöniger: 101.0%)
- Source and lot/batch No.of test material: M16LB4523
- Expiration date of the lot/batch: 2017-12-01 (retest date)
- Purity test date: 2017-04-19 (certificate of analysis release 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: Not available
Analytical monitoring:
yes
Details on sampling:
- Sampling method: singular samples for possible analysis were taken from all test concentrations with surviving fish and the control at t=0 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 and its instability in aquatic environment, saturated solutions (SS) were prepared. The preparation of test solutions started with a loading rate of 100 mg/L applying three days of magnetic stirring at room temperature to ensure maximum dissolution of the test item in test medium and full degradation of the test item to its metabolite. This resulted in a clear and colourless dispersion that contained undissolved material. The obtained mixture was filtered through a 0.45 µm membrane filter (Whatman; RC55) to remove the undissolved fraction. pH of the obtained SS was set from 4.2 to 6.6 in the range-finding test and from 4.3 to 6.5 in the full test with 1 M NaOH (Merck, Darmstadt, Germany) and used as the highest test concentration. Lower test concentrations in 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): All 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: 2.8 ± 0.3 cm, limit test: 2.5 ± 0.1 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.27 ± 0.07 g, limit test 0.17 ± 0.06 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 ((Essence (300-500 um), Coppens International bv, Helmond, The Netherlands)
- 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:
not reported
Test temperature:
20-24 °C
pH:
6.5-8.0
Dissolved oxygen:
7.4-8.9
Salinity:
not relevant
Conductivity:
not indicated
Nominal and measured concentrations:
Range-finder:
Nominal concentrations: 1, 10 and 100% of SS (1 and 10% of SS not analysed)
Measured concentrations at t=0h: 88.5 mg/L
Measured concentrations at t=24h: 98.1 mg/L
Measured concentrations at t=96h: 98.6 mg/L

Final test:
Nominal concentrations: 0 and 100% of SS (Saturated solution prepared at a loading rate of 100 mg/L)
Measured concentrations at t=0h: n.d., 92.4 mg/L
Measured concentrations at t=96h: n.d., 91.3 mg/L
n.d. = not detected
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 6.5 L, all-glass filled with 5 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: 0.24 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3.

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 mg/L (1%, 10% and 100% v/v dilutions of a saturated solution with 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:
EC50
Effect conc.:
> 100 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
- Mortality observed at the limit test concentration: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50/LC50: 96-h LC50 = 0.32 mg/L.
Reported statistics and error estimates:
No LC50 could be calculated because the effects were below 50% (LC50 > maximum concentration tested).
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of 4-nitrobenzene-1-sulfonylchloride to carp was determined in a 96-hour static limit test according to OECD guideline 203. Under the conditions of the present study, the 96-h EC50 exceeded the analytically confirmed nominal concentration of 100 mg/L. The results of the test can be considered reliable without restriction.

Description of key information

The study of Tobor-Kaplon (2018), investigating the acute toxicity of 4-nitrobenzene-1-sulfonyl chloride in carp according to OECD guideline 203, was considered as the key study for endpoint coverage. A EC50 > 100 mg/L (based on analytically confirm nominal test concentrations) was obtained after an exposure of 96 hours in a static test in freshwater. Based on the results it can be considered that 4-nitrobenzene-1-sulfonyl chloride is not harmful to fish.

Key value for chemical safety assessment

Additional information