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Ecotoxicological information

Short-term toxicity to fish

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short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 - 06 Jul 2001
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
Jul 1992
according to guideline
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Dec 1992
GLP compliance:
yes (incl. QA statement)
Niedersächsisches Umweltministerium, Hannover, Germany
Analytical monitoring:
Details on sampling:
- Concentrations: control, and 100 mg/L
- Sampling method: of the 6 L freshly prepared test suspension, 1 L was used for analysis
- Sample storage conditions before analysis: if necessary, samples were stored at 7 ± 2 °C until analysis
Details on test solutions:
- Controls: yes, dilution water without test item
- Evidence of undissolved material: no, the test item was clearly dissolved throughout exposure after filtration with 0.45 µm filters
Test organisms (species):
other: Brachydanio rerio
Details on test organisms:
- Common name: Zebra fish
- Length at study initiation: average body length = 2.46 cm
- Weight at study initiation: average body weight = 0.13 g
- Maintenance of the brood fish: in tap water of local origin, previously filtered (activated charcoal) and aerated for at least 24 h to remove chlorine, at 23 ± 2 °C and diffuse light (0.1 - 10 µmol/m2s, natural photoperiod). Water was changed at least once a week.

- Acclimation period: at least 12 d
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Trouvit 40/2; Milkivit (Bürgheim, Germany), 4 % of the fish body weight per feeding day.
- Feeding frequency during acclimation: 3 times per week

no feeding
Test type:
Water media type:
Limit test:
Total exposure duration:
96 h
40 - 180 mg CaCO3/L
Test temperature:
23 ± 2 °C
6.0 - 8.0
Dissolved oxygen:
not less than 60% of air saturation value
Nominal and measured concentrations:
nominal: control, and 100 mg/L
measured: control, and 0.10 mg/L
Details on test conditions:
- Test vessel: glass-aquaria
- Type: loosely covered by glass tops
- size, headspace, fill volume: Fill volume: 5 L per vessel
- Aeration: yes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 g fish per Liter test solution

- Source/preparation of dilution water: local tap water, filtered (activated charcoal) and aerated for at least 24 h to remove chlorine
- Culture medium different from test medium: no, same
- Intervals of water quality measurement: the water is analysed once a year according to German tap water regulation

- Adjustment of pH: no
- Photoperiod: natural
- Light intensity: 0.1 - 10 µmol/m2s

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- pH, temperature and O2 saturation: at the beginning of the test and every 24 h from old and new media
- total hardness: at the beginning (from the test control)
- analytic verfication: every 24 h: after 0 h and 72 h (freshly prepared media), after 24 h and 96 h (old media)
- room temperature: continuously
- mortality and behaviour: after 2, 24, 48, 72 and 96 h

- Range finding study: yes
- Test concentrations: control, 100 mg/L (nominal), 0.22 mg/L (initially measured)
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
Key result
96 h
Dose descriptor:
Effect conc.:
> 0.1 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no
- Mortality of control: 0%
- Other adverse effects control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
according to the guideline, no reference item is recommended for this test
Sublethal observations / clinical signs:

The test item was analytically verified by GC-FID at the limit concentration and control after 0 h and 72 h (new media) and after 24 h and 96 h (old media). The saturated solutions (new media) prepared and measured after 0 h and 72 h contained 0.1 mg/L of the test item whereas the test item could not be detected after 24 h of exposure. The test item is supposed to be metabolised during the test. Therefore, all effect concentrations are given based on the initially mean measured test concentrations.

Validity criteria fulfilled:
LC50 (96 h) > 0.1 mg/L (initial mean measured concentration of saturated solution, limit test at nominal concentration of 100 mg/L, OECD 203, Danio rerio)

Description of key information

LC50 (96 h) > 0.1 mg/L (initial mean measured concentration of saturated solution, limit test at nominal concentration of 100 mg/L, OECD 203, Danio rerio)

Key value for chemical safety assessment

Additional information

There is one GLP certified guideline study available, which assessed the acute aquatic toxicity of the test substance to fish according to the OECD guideline 203.

In a semi-static test with daily renewal of the test media Danio rerio were exposed to a nominal limit concentration of 100 mg/L test substance for 96 h under controlled conditions. The limit concentration was previously established in a preliminary range-finding test.

The test substance was analytically verified by GC-FID at the limit concentration and in the control in new media (prepared and measured at 0 and 72 h) and in old media (at 24 and 96 h). In new media the measured concentration was 0.10 mg/L. In 24 h old media, no test item could be detected and it was proposed that the test item is metabolised during the test. Therefore, all effect values are based on the mean initial concentration measured.

The limit concentration caused no mortality or non lethal effects. Therefore, the EC50 (96 h) was > 0.1 mg/L mean initial concentration measured, which represents the maximum soluble concentration under test conditions.