Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October-November 1997
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RA 3643
- Physical state: white powder
- Lot/batch No.: 87/96
- Storage condition of test material: stored in a refrigerator

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Details on test solutions:
The dilution water was DSWL, prepared from ground water.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Brachydanio rerio
- Source: M.B.Ruysbroek B.V. (Noordvliet 159, Maassluis)
- Length at study initiation (length definition, mean, range and SD): 1.95 +/- 0.11 cm
- Weight at study initiation (mean and range, SD): 0.06 +/- 0.01 cm
- Amount: 10 fish

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
202 mg/l
Test temperature:
24.9-25.6 °C
pH:
7.7-8.3
Dissolved oxygen:
The lowest value was 7.5 mg/l
Reference substance (positive control):
yes
Remarks:
0.01 ml/l DMSO

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.
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 2.48 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 2.48 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.

Any other information on results incl. tables

There was no mortality in the control medium. No adverse effects observed.

Applicant's summary and conclusion

Conclusions:
The test item is not acutely toxic to the zebra fish Brachydanio rerio, with respect to survival and condition, when exposed at its aqueous solubility level.