Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study. The oxygen saturation was below 60% at one single measurement (42% after 24 h at 2 mg/L treatment). Variation of temperature > ± 1°C was observed, however exceeded this range only slightly. These deficiencies are not considered to influence the results of the study.
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solution was daily prepared by adding 0.1 g test substance to 1 L dilution water and stirring for 30 minutes. The different test concentrations were prepared by adding respective amounts of stock solution to the test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Source: Westaquarium, Germany (obtained 04 Jul 1995)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: SSNIFF M
- Health during acclimation (any mortality observed): < 0.1% during the last 7 days before test start
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
not specified
Test temperature:
22.1 - 24.4 °C
pH:
8.0 - 8.4
Dissolved oxygen:
> 60% saturation
Nominal and measured concentrations:
Nominal: 0.5, 2, 4 and 8 mg/L
Measured: 0.5 mg/L: 0.2 mg/L (0h) - 0.1 mg/L (24h); 2 mg/L: 1.8 mg/L (0h) - 1.2 mg/L (24h); 4 mg/L: 3.5 mg/L (0h) - 2.7 mg/L (24h)
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 L aquaria with 5 L fill volume
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water (copper and chlorine free)

OTHER TEST CONDITIONS
- Photoperiod: 16h light : 8h dark

EFFECT PARAMETERS MEASURED: Mortality was recorded after 0, 24, 48, 72 and 96 h test duration.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.46 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.33 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
0.65 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: disturbed equilibrium after 2-4h for fish of the 2 mg/L treatment
- Observations on body length and weight: not stated
- Other biological observations: not stated
- Mortality of control: none
- Other adverse effects control: not stated
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: slight turbidity at 2 and 4 mg/L and more turbidity at 8 mg/L
- Effect concentrations exceeding solubility of substance in test medium: yes, but effect concentration were adjusted to mean recovery of 60.8%
Validity criteria fulfilled:
yes
Conclusions:
In a GLP study according to EU Method C.1, the 96-LC50 value of the test substance for acute toxicity to fish is determined to be 0.46 mg/L.
Executive summary:

The study was performed according to EU Method C.1 under GLP conditions. In a semi-static study Brachydanio rerio was exposed to the test substance for 96 h. The test material was applied directly, i.e. without solvent. Analytical monitoring was performed. All validity criteria were fulfilled. The 96h-LC50 value is determined to be 0.46 mg/L based on measured concentrations.

Description of key information

LC50 (96h) = 0.46 mg/L (nominal) for Brachydanio rerio (EU method C.1)

Key value for chemical safety assessment

LC50 for freshwater fish:
0.46 mg/L

Additional information

One study investigating the short-term toxicity of the test substance to freshwater fish is available. The study was performed according to EU Method C.1 under GLP conditions (Scholz 1995). In a semi-static study Brachydanio rerio was exposed to the test substance for 96 h. The test material was applied directly, i.e. without solvent. Analytical monitoring was performed. All validity criteria were fulfilled. The 96h-LC50 value is determined to be 0.46 mg/L based on measured concentrations.