Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 18, 1996, to March 28, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
1992
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Start and end of study period

Test solutions

Vehicle:
yes
Details on test solutions:
Since the substance is practically insoluble in water (<9 µg/l), 0.1 ml/l acetone was used as a pre-solvent in the stock solution. Nevertheless, the final test solutions were pink with undissolved test item particles floating at the surface.

Test organisms

Test organisms (species):
Cyprinus carpio

Study design

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

Test conditions

Test temperature:
20.5 - 21.0 °C
pH:
7.2 - 8.2
Dissolved oxygen:
6.6 - 9.8 mg O2/l
Nominal and measured concentrations:
- Nominal concentration: 1.0 mg/l limit test
- Measured concentration: 1.07 mg/l at the start of the test; 0.26 mg/l at the end
Reference substance (positive control):
yes
Remarks:
pentachlorophenol, 0.1 - 1.0 mg/l

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
not determinable
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No mortality occurred in the treatment, control or solvent control groups. Concentration levels acutely toxic for this species of fish could not be reached, owing to the very low solubility of the test item in water (< 9 µg/l at 20.0 ± 0.5 °C). Therefore, the 96 hour LC50 value was far beyond the maximum solubility in water.
Results with reference substance (positive control):
LC50 (96h) = 0.42 mg/l

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
LC50 (96h, Cyprinus carpius) > maximum solubility limit
No mortality at the highest tested concentration of 1.0 mg/l (nominal).