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Short-term toxicity to fish

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short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
Analytical monitoring:
Details on sampling:
Test solution samples were taken at the beginning and end of each renewal period i.e. when the media has been fresly prepared and immediately prior to renewal or at the end of the exposure period. Two sets of solutions (before exposure/after 24 hours, and after renewal at 72 hours/end of expoure at 96 hours) were taken.
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Concentrations prepared by diluting from a stock solution with a loading rate of 100 mg/L. This stock solution was prepared 48 hours prior to dilution and stirred continuously. The resultion solution was then filtered and further stirred prior to use.
- Controls: Dechlorinated water was used as the control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): None observed
Test organisms (species):
Oryzias latipes
Details on test organisms:
- Common name: Medaka
- Strain: N/A
- Source: In house breeding centre at the test facility
- Age at study initiation: Less than half a year after hatching
- Length at study initiation: 2.28 cm (2.06 to 2.58 cm) n = 10
- Weight at study initiation: 0.098 g (0.065 to 0.141 g) n = 10

- Acclimation period: 2 months
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food during acclimation: 2% of bodyweight per day (until 24 hours before exposure)
- Feeding frequency during acclimation: Daily
- Health during acclimation (any mortality observed): Less than 5% mortality observed

Test type:
Water media type:
Limit test:
Total exposure duration:
96 h
47 mgCaCO3/L
Test temperature:
23.7 to 24°C
6.8 to 7.4 (not adjusted)
Dissolved oxygen:
6.7 to 8.7 mg/L
Not detailed
13 mS/m
Nominal and measured concentrations:
Nominal: 0.05, 0.11, 0.22, 0.47 and 1.0 mg/L
Measured (time-weighted mean): 0.0185, 0.0397, 0.0886, 0.18 and 0.465 mg/L
Details on test conditions:
- Test vessel: 5L glass vessel
- Type (delete if not applicable): open (covered with teflon sheet)
- Material, size, headspace, fill volume: Filled to 5L
- Aeration: Not aerated
- No. of organisms per vessel: 10 fish per vessel
- No. of vessels per concentration (replicates): 1 vessel per concentration
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 g fish/L or less

- Source/preparation of dilution water: Prepared by treating tap water with an activated carbon filter and sodium thiosulfate.
- Total organic carbon: Not detected (< 0.3 mg/L)
- Particulate matter: Not detected (< 1 mg/L)
- Metals: Various metals analysed for and below detection limits
- Pesticides: Various pesticides analysed for and below detection limits
- Chlorine: Not detected (< 0.1 mg/L)
- Alkalinity: 39 mg CaCO3/L
- Culture medium different from test medium: No
- Intervals of water quality measurement: Routinely analysed (around every 6 months)

- Adjustment of pH: no
- Photoperiod: 16 hour light/8 hour dark
- Light intensity: 1000 Lux or less

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and toxicological symptoms

- Spacing factor for test concentrations: 2.1
- Range finding study
- Test concentrations: 1, 10 and 100 mg/L used in first range finder and 0.01 and 0.1 used in second range finder
- Results used to determine the conditions for the definitive study: The rangefinder showed 100% mortality as low as 1 mg/L with no effects observed at 0.01 mg/L. This information was used to set the concentrations for the main phase.
Reference substance (positive control):
Copper sulphate, hydrous
96 h
Dose descriptor:
Effect conc.:
0.045 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Confidence limits: 0.0322 to 0.0623 mg/L)
Details on results:
- Behavioural abnormalities: Abnormal swimming was observed at 0.11 mg/L (1 fish at 24 hours), 0.22 mg/L (2 fish at 24 hours) and at 0.47 mg/L (1 fish at 3 hours)
- Observations on body length and weight: Not determined
- Other biological observations: None noted
- Mortality of control: 0%
- Other adverse effects control None noted:
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No precipitation observed
Results with reference substance (positive control):
- Results with reference substance valid? Results valid (within the range of historical laboratory data)
- Mortality: Observed
- LC50: 0.26 mg/L
Reported statistics and error estimates:
Probit used to determine the 96 hour LC50 value and relevant confidence limits
Validity criteria fulfilled:
No mortality observed in the control group and DO remained at acceptable levels.
An OECD guideline, GLP study assessing the acute toxicity of the substance to fish provided a 96 hour LC50 value of 0.0448 mg/L.

Description of key information

A reliable OECD guideline and GLP study is available assessing the acute toxicity of the substance to fish. No data is available assessing the toxicity of the substance to marine fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.045 mg/L

Additional information