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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1993-09-13 to 1994-01-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
EG 92/69
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1984
Deviations:
no
Qualifier:
according to
Guideline:
other: DIN 38412 Part 1
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Remarks:
Thin-layer chromatography (TLC)
Vehicle:
no
Details on test solutions:
Stock solution preparation:
- 10.12 g of the test item were dissolved in 1 L deionised water.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: West Aquarium, Bad Lauterberg, Germany
- Length at study initiation: 3 ± 0.5 cm
- Weight at study initiation: average 0.3 g
- Maintenance of the brood fish: Fish were kept in dechlorinated drinking water in 200 Lstone basins or in 300 L glass aquariums at 20 ± 2 °C.
- Type and amount of food: TetraMin, amounts of 1 % of the bodyweight
- Feeding frequency: administered daily

QUARANTINE
- Pre-treatment: treated 3 times a week with Malachite Green
- Duration: 14 days
- Health/mortality: The animals showed normal behaviour pattern and they were free from obvious diseases.
Test animals were used for tested only after the guarantine period.

FEEDING DURING TEST: no feeding during the test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
12.0 °dH
Test temperature:
20 °C
pH:
7.8 - 9.1
Dissolved oxygen:
6.0 - 9.1 mg/L
Nominal and measured concentrations:
Nominal concentration: 100 mg/L
Measured concentration: 104 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: aquariums
- Material, size, headspace, fill volume: glass, 20 L
- Aeration: continuously
- 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: deionised drinking water

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 h light/darkness
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Details on results:
The biological effects are based on the nominal concentration as less than ± 20 % deviation in the measured concentration with regard to the nominal was determined.
The test concentration showing no effects (<= 10%) after 96 h was determined to be LC0 = 100 mg/L.

Table 1. Limit test results of mortality

Concentration (mg/L)

Results

24 h

48 h

72 h

96 h

alive

dead

%

alive

dead

%

alive

dead

%

alive

dead

%

0

10

0

0

10

0

0

10

0

0

10

0

0

100

10

0

0

10

0

0

10

0

0

9

1

10

Validity criteria fulfilled:
yes
Conclusions:
The LC0 after 96 h was determined to be 100 mg/L. Therefore, the LC50 is determined to be higher than 100 mg/L.
Executive summary:

The acute toxicity of the test item to fish (Zebrafish) was determined according to the OECD Guideline 203 (1984), EG 92/69 method C.1 and DIN 38412 Part 1. A semi-static test was performed as a limit test with a concentration of 100 mg/L. The test item solution was prepared by mechanical dispersion – 10.12 g test item were dissolved in 1 L deionised drinking water. Ten test organisms were exposed to the test concentration and the control, respectively, for 96 hours. The measured concentration of the test item at the start of the renewal periods was 100 mg/L and at the end of the renewal periods was 104 mg/L, respectively. The limit concentration of the test item was found to have no effect on the vitality of zebrafish. In conclusion, the LC0 corresponds to the nominal concentration 100 mg/L. The LC50 correspond to the nominal concentration >100 mg/L.

Description of key information

The LC0 after 96 h was determined to be 100 mg/L. Therefore, the LC50 is determined to be higher than 100 mg/L.

Key value for chemical safety assessment

Additional information

The acute toxicity of the test item to fish (Zebrafish) was determined according to the OECD Guideline 203 (1984), EG 92/69 method C.1 and DIN 38412 Part 1. A semi-static test was performed as a limit test with a concentration of 100 mg/L. The test item solution was prepared by mechanical dispersion – 10.12 g test item were dissolved in 1 L deionised drinking water. Ten test organisms were exposed to the test concentration and the control, respectively, for 96 hours. The measured concentration of the test item at the start of the renewal periods was 100 mg/L and at the end of the renewal periods was 104 mg/L, respectively. The limit concentration of the test item was found to have no effect on the vitality of zebrafish. In conclusion, the LC0 corresponds to the nominal concentration 100 mg/L. The LC50 correspond to the nominal concentration >100 mg/L.