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Ecotoxicological information

Short-term toxicity to fish

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 August 2017 to 16 October 2017 (experimental period)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Control and all test concentrations
- Sampling method: 2.0 mL from approximate centre of test vessels
- Sample storage conditions before analysis: Stored in a freezer (
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were prepared at nominal 100 mg/L in adjusted ISO medium. Test solutions were stirred for 3 days by magnetic stirrer to ensure maximum dissolution and homogenisation of test substance. After stirring the saturated solution was filtered through 0.45 um membrane filter. Lower test solutions (range-finding only) were prepared by dilution in adjusted ISO medium of the nominal 100 mg/L saturated solution. Test solution preparation was under dimmed light conditions with glassware covered in aluminium foil
- Eluate: Adjusted ISO medium with 180 mg CaCO3 per litre, using RO water
- Differential loading: No
- Controls: Adjusted ISO medium only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, 'De Haar Visson', Wageningen University and Research Centre, The Netherlands
- Age at study initiation (mean and range, SD): No data
- Length at study initiation (length definition, mean, range and SD): 2.8 +/-0.3 cm
- Weight at study initiation (mean and range, SD): 0.27 +/-0.07 g
- Method of breeding: F1 from single parent pair
- Maintenance of the brood fish: No data

ACCLIMATION
- Acclimation period: At least 12 days
- Acclimation conditions (same as test or not): Not specified
- Type and amount of food during acclimation: Pelleted fish food (Cyprico Crumble Excellent)
- Feeding frequency during acclimation: Daily
- Health during acclimation (any mortality observed): <5% mortality in 7 days prior to study start

FEEDING DURING TEST
Fish were not fed during the test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
16h daily photoperiod; dimmed light (5 lux)
Hardness:
No data
Test temperature:
21 to 22 oC
pH:
7.5 to 7.9
Dissolved oxygen:
7.1 to 9.2
Salinity:
No data
Conductivity:
No data
Nominal and measured concentrations:
Nominal: 100 mg/L saturated solution
Measured: 0.058 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 6.5 L all glass
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 4.5 L fill volume
- Aeration: No
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: RO water

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16h, reduced light (5 lux)
- Light intensity: No data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable
- Range finding study:
- Test concentrations: 1.0, 10 and 100% saturated solution.
- Results used to determine the conditions for the definitive study: Yes
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
>= 0.058 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
>= 0.058 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
>= 0.058 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 0.058 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Average measured concn (mg/L)

Initial no. of fish

Cumulative mortality

Total mortality (%)

3h

24h

48h

72h

96h

Control

7

0

0

0

0

0

0

0.058

7

0

0

0

0

0

0

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour LC50 (mortality) for common carp (Cyprinus carpio) was beyond the range tested, ie exceeded the average measured exposure concentration of 0.058 mg/L. The LC50 (mortality) was determined to be >0.058 mg/L under the conditions of the test.
Executive summary:

A 96-hour acute toxicity study with common carp (Cyprinus carpio) was conducted in accordance with the OECD test guideline 203 and in compliance with GLP.

A limit test was performed with a single test concentration of 100% saturated solution of a nominal 100 mg/L solution, under semi-static conditions. The average measured test concentration was determined to be 0.058 mg/L.

Under the conditions of the test, the 96-hour LC50 (mortality) was determined to be >0.058 mg/L, based on average measured concentrations.

This acute toxicity study is considered acceptable and satisfies the guideline requirement for short-term toxicity to fish.

Description of key information

A 96-hour acute toxicity study with common carp (Cyprinus carpio) was conducted in accordance with the OECD test guideline 203 and in compliance with GLP.

A limit test was performed with a single test concentration of 100% saturated solution of a nominal 100 mg/L solution, under semi-static conditions. The average measured test concentration was determined to be 0.058 mg/L.

Under the conditions of the test, the 96-hour LC50 (mortality) was determined to be beyond the range tested ie exceeded the average measured concentration of >0.058 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.058 mg/L

Additional information