Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 94.5% contains residual water

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
The substance was suspended with 0.095 ml Tween 80/l to support the solution properties.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrabärbling
- Strain: Hamilton-Buchanan
- Source: West Aquarium, 3422 bad Lauterberg
- Age at study initiation: about 3 months
- Length at study initiation: 3.1 +- 0.21 cm
- Feeding during test: twice a day, ad libitum
- Food type: Tetra Standard Mix, Tetra Werke, Melle

ACCLIMATION
- Acclimation period: at least 14 days
- Acclimation conditions: same as test

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no

Test conditions

Test temperature:
21.4 - 22.0 °C
pH:
7.3 - 8.2
Dissolved oxygen:
4.8 - 8.8 mg O2/L
Nominal and measured concentrations:
Nominal concentration: 500 mg/L
Analytically found after 0 hours: 272 mg/L; after 48 hours 98.8 mg/L; after 96 hours: 101 mg/L
average was calculated for 99.9 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 liter glass vessel, (30 cm x 22 cm x 24 cm), open
- Aeration: after 72 hours

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: according to ISO/DIS 7346/1

Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
99.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 99.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No change in appearance and behaviour

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Based on the test result, the substance has not to be classifed for toxicity to the fish.
Executive summary:

The substance was tested for acute toxicity to the zebrabärbling according to OECD guideline 203. The nominal concentration was 500 mg/L. Due to the poor solubility of the substance the effective concentration was determined by HPLC and was found to be in average 99.9 mg/L.Tween 80/l was used to support the solubility. Tests were performed with 10 fish with 500 mg/L nominal and 0 mg/L , 0 mg/L plus Tween 80 as controls. There was no mortality and also no change in the appearance and the behaviour of the fish after 96 hours.

Therefore the LC50 is > 500 mg/L (nominal) rsp. > 99.9 mg/L (measured)