Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Jun. 27, 1988 to Aug. 8, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guideline, with GLP-like Quality Assurance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
Test performed as limit test with conc. 100 mg/l nominal. Highest vehicle concentration 950 mg/l; acclimatisation 11 days
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: beige crystalls
- Analytical purity: commercial grade
- Lot/batch No.: EN.116905.72
- Expiration date of the lot/batch: 11/92
- Storage condition of test material: room temperature

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L.
- Sampling method: Samples for analysis were taken at the start and at the end of the exposure.
- Sample storage conditions before analysis: Not available.

Test solutions

Vehicle:
yes
Details on test solutions:
Stock solution: 5.0 g test substance were dissolved in and made up to 50 ml with DMF.
Highest vehicle concentration: 950 mg/L.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra-Fish.
- Source: West Aquarium / D-3422 Bad Lauterberg.
- Length at study initiation (length definition, mean, range and SD): 20 mm (16-25 mm).
- Weight at study initiation (mean and range, SD): 0.06 g (0.03-0.11 g).



ACCLIMATION
- Acclimation period: 11 days.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Not applicable.

Test conditions

Hardness:
188 mg CaC03/L.
Test temperature:
23 ± 1°C.
pH:
8.0-8.5.
Dissolved oxygen:
93-102%.
Salinity:
freshwater
Nominal and measured concentrations:
Nominal concentration: 100 mg/L . Refer to Table 1.
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquaria of 20 liters filled with 15 liters (36/22/25 cm).
- Type (delete if not applicable): open
- Aeration: None
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.04 g/l

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water (carbon filter).
- Intervals of water quality measurement: oxygen, pH, temperature daily
OTHER TEST CONDITIONS
- Photoperiod: Fluorescent light, 16 hours daily.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Mortalities, swimming behaviour, loss of equilibrium, respiratory function, exophtalmus, and pigmentation observed 24, 48, 72 and 96 hours
Reference substance (positive control):
not required

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: None
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: None
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: None
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: None
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: None
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: None
Details on results:
Refer to Tables 2 and 3.
Results with reference substance (positive control):
Mortalities in blank (water) : 0%
Mortalities in vehicle (DMF) : 0%
Reported statistics and error estimates:
None.

Any other information on results incl. tables

Table 2. Mortalities

Concentration

nominal

mg/ L

Mortalities

Number of dead fishes

24 h

48 h

72 h

96 h

Blank

0

0

0

0

Vehicle

0

0

0

0

100

0

0

0

0

100

0

0

0

0

Table 3 Symptoms observed at the different test concentrations

Concentration

nominal

mg/ L

Swimming behaviour

Loss of equilibrium

Respiratory function

Exophtalmus

Pigmentation

24

48

72

96h

24

48

72

96h

24

48

72

96h

24

48

72

96h

24

48

72

96h

Blank

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Vehicle

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

100

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

100

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Effect :

0: normal

1: slight

2: moderate

3: severe

Applicant's summary and conclusion