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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
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with analytical monitoring.
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
Details on test solutions:
- Since the test item is poorly soluble in water, a modification of the standard method for the preparation of aqueous media was performed with help of water accomodated fractions (WAF).
- Using this approach, aqueous media were prepared by shaking the test item with dilution water at 20 rpm for 24 hours at room temperature to ensure equilibration between the test item and the water phase.
- For each loading level, an appropriate amount of the test item was weighed out and transferred into a brown glass flask with an appropriate amount of dilution water.
- After the completion of shaking and following a 1-h settlement period, the test item phase was separated by siphon and the test organisms exposed to the clear aqueous phase, the WAF.
- Exposures are expressed in terms of the original concentrations of the test item in water at the start of the mixing period (loading levels) irrespective of the actual concentrations of the test item in the WAFs.
- WAFs were prepared with dilution water
- The test solutions showed loading level related turbidity throughout the exposure period.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Origin: all fish used in the test originated from a single brood stock at DR.NOACK-LABORATORIEN
- Supplier: Umweltbundesamt, Schichauweg 58, 12307 Berlin, Germany
- Mean length of fish: 2.2 cm
- Mean weight of fish: 0.164 g
- Holding: fish were held at the test facility at 23 +- 2 °C and diffuse light (0.1 - 10 µmol photons * m-2*s-1, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value.
- Acclimatization period: at least 12 days
- Medication: no disease treatments were administered throughout holding and testing
- Holding water: tap water of local origin. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
Total hardness: 10 - 250 mg CaCO3/L
pH-value: 6.0 - 8.5
- Feeding: thrice weekly. Amount of food was 4 % of fish body weight per feeding day. Fish weren't fed 24 h before test initiation
- Food: Sera Vipan; SERA GMBH, 52518 Heinsberg, Germany

Test type:
Water media type:
Limit test:
Total exposure duration:
96 h
50 mg/L CaCO3
Test temperature:
21.4 - 22.9 °C
6.92 - 8.06
Dissolved oxygen:
Oxygen saturation: 87 - 100 %
Nominal and measured concentrations:
- Nominal loadings of the test item: 5.00, 10.0, 20.0, 40.0 and 80.0 mg/L plus control
- Recovery of test concentrations between 103 - 122 % of nominal values
Details on test conditions:
- Test vessel: glass aquaria (3 L volume; 11.5/13/20 cm, depth of water: 13.5 cm) covered with glass plates
- Test volume: 2 L
- Test medium: dilution water (same as for holding)
- Aeration: gentle aeration was provided
- No. organisms / control: 7
- No. organisms / replicates: 7
- No. replicates / loading level and control: 1
- Fish density in the tanks: 0.574 g fish per L test solution
- Feeding of fish during test: none
- Renewal period: daily

- Light intensity (target): 0.1 - 10 µmol photons * m-2 * s-1
- Photoperiod: a natural photoperiod occurred during the exposure
Reference substance (positive control):
96 h
Dose descriptor:
Effect conc.:
14.1 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL 10.0 - 20.0
Details on results:
- Behavioural observations: slowed escape reflexes and remainder of fish at the water surface for an unusually long time starting at the loading level of 20 mg/L
Validity criteria fulfilled:

Description of key information


In an acute test with Danio rerio acoording to OECD TG 203, effects have been observed. The LL50 value is 14.1 mg/L. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
Effect concentration:
14.1 mg/L

Additional information

There are two guideline studies available on the acute toxicity of the test substance to fish. In the key study the effects of the water accomodated fraction (WAF) of the test substance with 5 different loadings were examined according to OECD guideline 203. Brachydanio rerio was used as test organism [Dr. U. Noack-Laboratorien, 2013]. The experiment was conducted under semi-static conditions over a test period of 96 h and the test loadings were monitored analytically. At test termination, an LL50 of 14.1 mg/L (nominal) was determined.