Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-10-12 to 1987-10-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1984
Deviations:
no
GLP compliance:
no
Remarks:
However, Quality Assurance Statement available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: samples were taken from all concentrations plus the blank and the vehicle control to measure oxygen, pH and temperature at the time points 0h, 24 h, 48 h, 72 h and 96 h

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Calculated amounts of test substance to produce the desired test concentrations were given into the water and homogeneously distributed. The fishes were then transfered into the aquaria.
- Controls: Blank: water; vehicle: 95 mg DMF per liter water
- Evidence of undissolved material: The test substance appeared homogeneously distributed in all test concentrations.
- Stock solution: 1.00 g of the test substance was dissolved in and made up to 10 ml with DMF
- Concentration of vehicle in test medium: 95 mg DMF per liter water in the concentration used for the highest test concentration

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Strain: Brachydanio rerio
- Source: West-Aquarium, 3422 Bad Lauterberg, Germany
- Length at study initiation: 23 mm (18-25 mm)
- Weight at study initiation: 0.09 g (0.06-0.12 g)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 40 days
- Acclimation conditions: same as test


Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
none

Test conditions

Hardness:
180 mg CaCO3/L
Test temperature:
22+/- 1 °C
pH:
8-8.3
Dissolved oxygen:
no data
Salinity:
no data
Nominal and measured concentrations:
test concentrations (nominal): 1.0, 1.8, 3.2, 5.0, 10.0, mg/L
measured (after 96 h): 1.2, 2.1, 3.2, 5.9, 10.0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: aquaria
- Material, size, headspace, fill volume: Glass aquaria of 20 liters filled with 15 liters (36/22/25 cm)
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.06 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water (carbon filter)


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


TEST CONCENTRATIONS
- Test concentrations: 1.0 1.8 3.2 5.0 10.0 mg/L (nominal)
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
5.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: At the concentration of 10 mg/L severe symptoms cocnerning swimming behaviour, loss of equilibrium and respiratory functions were observed after 96 h of exposure. At the concentration of 5.8 mg/L moderate effects concerning swimming behaviour and loss of equilibrium and slight efffects on respiratory function were observed after 96 h.
- Mortality of control: none
- Any observations that might cause a difference between measured and nominal values: The test substance appeared homogeneously distributed in all test concentrations.
Reported statistics and error estimates:
The LC50 values were calculated according to J.BERKSON , JASA 48 (1953), 569-599. LC50 (96 h) was graphically determined on gausso-logarithmic probability paper.

Any other information on results incl. tables

The test substance appeared homogeneously distributed in all test concentrations.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test substance is acutely toxic to fish.