Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

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:
20th - 24th January 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
Study Plan specified the study will be performed in a temperature controlled lab at 22 ± 2°C. The test temperature was recorded at 19.0 - 20.5°C. In the opinion of the Study Director this deviation had no effect on the outcome of the study.
Qualifier:
according to guideline
Guideline:
other: JMAFF 2-7-1, Acute Fish Toxicity
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Source: Hampshire Carp Hatcheries, Bowlake Fish Farm, 5 Segars Lane, Twyford, Winchester, Hampshire, SO21 1QJ, UK.

ACCLIMATION
- Acclimation period: 11 October 2013 - 20 January 2014
- Acclimation conditions (same as test or not): Temperature: 20.0 - 21.0°C; pH: 7.89 - 8.18; Dissolved oxygen: 85 - 98% ASV; Photoperiod: 16 hours light and 8 hours dark
- Type and amount of food: Nutrafin Max Goldfish Flakes
- Feeding frequency: daily at a rate of approximately 1-2% body weight per day until 24 hours before test initiation. Not fed for the duration of study.
- Health during acclimation (any mortality observed): 0%
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
N/A
Hardness:
Sample from control vessel: 228 mg CaCO3/l
Test temperature:
Temperature of stock tank water at test initiation: 20.0°C
Temperature values recorded during test (°C): 19.0 - 20.5
pH:
pH of stock tank water at test initiation: 7.99
pH values recorded during test: 7.57 - 8.74
Dissolved oxygen:
Dissolved oxygen of stock tank water at test initiation: 96% ASV
Dissolved oxygen values recorded during test: 86 - 100%
Salinity:
N/A
Nominal and measured concentrations:
0 (control), 10, 26, 64, 160, 400 and 1000 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: All-glass aquaria of length 45.5cm x height 26cm x width 25.5cm
- Material, size, headspace, fill volume: Test volume: 20 litres
- Renewal rate of test solution (frequency/flow rate): test solutions replaced every day, the remaining live fish being carefully transferred to freshly prepared test solutions by net.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: The stocks of animals were maintained, and the tests performed, in a mixture of dechlorinated mains water and Reverse Osmosis (R.O.) treated mains water at a ratio of 80%:20%.
- Intervals of water quality measurement: pH, dissolved oxygen and temperature were measured immediately prior to initiating the test, before and after each daily change of test solutions and at the end of the 96 hour exposure period.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 24h, 48, 72h and 96h LC50; 24h, 48, 72h and 96h NOEC

TEST CONCENTRATIONS
- Results used to determine the conditions for the definitive study: Data supplied from the Sponsor on the toxicity of the test substance to fish indicated the NOEC was 10 mg/l and the 96h LC50 was >1000 mg/l.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Sub-lethal effects
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Sub-lethal effects
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Sub-lethal effects
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Sub-lethal effects
Reported statistics and error estimates:
Statistical analysis of the mortality data using Toxcalc was not carried out.
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of this study Epofloc L-1R was not found to be toxic.

Description of key information

The LC50 was determined to be > 1000 mg/l

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
1 000 mg/L

Additional information