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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:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
Limit Test 2 concentration tested
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
Limit Test 2 concentration tested
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SR 6947/14
- Expiration date of the lot/batch: June 1995

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: > 100 g/l
Analytical monitoring:
yes
Details on sampling:
Analytical control samples were taken at the beginning and at the end of the experiments, 50 mL each.
Vehicle:
no
Details on test solutions:
The test substance was disolved in 200 mL dechlorinated tap water and then added up to 3 Liters.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Test organism: Zebrafish.
- Source/Supplier: West Aquarium, Bad Lauterberg, BRD.
- Age at study initiation: 95 days.
- Length at study initiation: 29.3 mm.
- Weight at study initiation: 0.24 g.
- Feeding during test: No
- Acclimation period: 12 days.
- Acclimation conditions (same as test or not): Same as test conditions (held in dechlorinated tap water). No mortalities were reported during acclimation.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No
Hardness:
161 mg/L as CaCO3
Test temperature:
21.5 - 23.1 °C
pH:
7.8 - 8.3
Dissolved oxygen:
84 - 97 % of the air saturation value.
Nominal and measured concentrations:
- Nominal concentrations: 562 and 1000 mg/L
- Measured concentrations: 101.4 - 109.1 % of nominal.
Details on test conditions:
- Vessels: 5L Glass aquaria
- Type: open
- Volume: 3 L (2.9 after the analytical control samples were taken).
- Test concentration: In the pretest the LC50 was determined to be >1000 ppm. The test concentrations were chosen as 562 and 1000 ppm. A control was carried out with dechlorinated tap water.
- Diluent: In dechlorinated tap water.
- Mode of preparation: The test substance was disolved in 200 mL test water, which was slowly added to the fish bath
- Number of fish: 10 fish per concentration and water control
- Feeding: None
- Aeration: Slowly aerated
- Lighting: 12 hrs light/12 hrs darkness (yellow light TL 16/20 W).
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
At both tested concentrations a weak change in the swimming behavior of the test fish could be observed. No mortality occured.
Validity criteria fulfilled:
yes
Conclusions:
The 96h LC50 value of FAT 40406/A is determined to be greater than 1000 mg/L.
Executive summary:

Acute toxicity to fish of FAT 40406/A was determined in a study performed according to the OECD guideline 203 (1984) and the EEC Directive, Annex V, C.1 under GLP.

Deviations from the revised OECD 203 Guideline were observed in regard to the number of limit tests (two were conducted in different concentrations) and the excess of the 1000 mg/L limit concentration of test subsance.

During the pretest at 100, 300 and 1000 mg/L concentrations, no mortalities were observed.

For the main study, ten zebrafish per concentration were placed in a slowly aerated static system and exposed to 562 and 1000 mg/L of the test substance and blank control solution for 96 hours. Water samples were taken from the fish tank at the beginning and at the end of the experiment to determine concentrations of the test substance present. Measured concentrations were 101.4 - 109.1% of nominal.

No mortalities of the fish were observed in the test and control solutions, but weak changes in the swimming behavior of the test fish could be observed at both tested concentrations. Hence, the 96h LC50 value is determined to be greater than 1000 mg/L.

Description of key information

The 96-h LC50 of Reactive Red 245 is >1000 mg/L in zebra fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
1 000 mg/L

Additional information

Acute toxicity to fish of the test substance was determined in a study performed according to the OECD guideline 203 (1984) and the EEC Directive, Annex V, C.1 under GLP.

Deviations from the revised OECD 203 Guideline were observed in regard to the number of limit tests (two were conducted in different concentrations) and the excess of the 1000 mg/L limit concentration of test subsance.

During the pretest at 100, 300 and 1000 mg/L concentrations, no mortalities were observed.

For the main study, ten zebrafish per concentration were placed in a slowly aerated static system and exposed to 562 and 1000 mg/L of the test substance and blank control solution for 96 hours. Water samples were taken from the fish tank at the beginning and at the end of the experiment to determine concentrations of the test substance present. Measured concentrations were 101.4 - 109.1% of nominal.

No mortalities of the fish were observed in the test and control solutions, but weak changes in the swimming behavior of the test fish could be observed at both tested concentrations. Hence, the 96h LC50 value is determined to be greater than 1000 mg/L test substance.

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