Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Jan to March 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: mikrodispers
Details on test material:
Cibanon Blau 83962 Mikrodispers

Sampling and analysis

Analytical monitoring:
not specified

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Zebrafish: Danio rerio
Replicates: 10 per test concentration
Age: about 4-6 months
Size:3 cm
Weight: 0.25-0.35 g
Supplier: West Aquarium GmbH, D-3422 Bad Lauterberg.

Further standard conditions:
- Basins have been cleaned with RBS-35 solution (FLUKA 83462) and rinsed with clean water.
- Testing water should be kept at a pH between 6 and 8.5. In case of deviations, pH needs to be adjusted with NaOH or HCl solution.
- Acclimatization period: minimum 12 days at 21-25 °C.
- Feeding periods: daily (TETRA MIN, flocks, Dr. U.Baersch GmbH, D-4520 Melle, Germany)
- Day-night cycles: 12/12h
- Termination: For termination of the experiment MS-222 (Sandoz) should be used at 1% (Methacain).

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
Not available
Test temperature:
23°C
pH:
7.5 to 7.7
Dissolved oxygen:
7.7 to 8.0
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal concentrations: 100, 300 and 1000 mg/L
Details on test conditions:
Water:
- 3 liters for Zebra fish (active coal filtered), Water used according to ISO guidelines.

Basins:
- Full-glass basins, 17 liters basis (36x23x26 cm) tempered (cold-room); 5 liter basins (15x20x20 cm) tempered
Reference substance (positive control):
not specified

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
300 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
589.49 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
300 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
462.39 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- At 100 and 300 mg/L, all fishes survived after 48 and 96 hours of exposure time.
- At 1000 mg/L, all fishes survived until 4 hours of exposure time and all died after 24 hours of exposure time.

Applicant's summary and conclusion

Conclusions:
The LC50 of the test substance in this fish acute toxicity test was determined to be 589.49 mg/L and 462.39 after 48 and 96 hours exposure time, respectively.
Executive summary:

The acute fish toxicity test was performed according to Method A-11.

10 Zebra fish were used in this test at each dose level.

The fish were tested at these differents follwing concentrations: 100, 300 and 1000 mg/L as in the pre-test all fishes survived at 100 mg/L.

- At 100 and 300 mg/L, all fish survived after 48 and 96 hours of exposure time.

- At 1000 mg/L, all fish survived until 4 hours of exposure time and all died after 24 hours of exposure time.

Results:

After 48 hours exposure time:

LC0 =300 mg/L

LC50 = 589.49 mg/L

LC100 =1000 mg/L

After 96 hours exposure time:

LC0 =300 mg/L

LC50 462.39 mg/L

LC100 =1000 mg/L

The LC50 of Vat Blue 66 in this fish acute toxicity test was determined to be 589.49 mg/L and 462.39 mg/L after 48 hours and 96 hours exposure time, respectively.