Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented but no data concerning GLP compliance. Screening test. No analytical validation method is joined to the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes
Details on test material:
The test item is dissolved directly in test water. The obtained preparation is agitated mechanically for up to 24h in an attempt to completely dissolve or disperse the test item.

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
yes
Details on test solutions:
The test solutions will be prepared by further dolution of the stock solution with water or directly for the test item.
3 ranges : 1, 10 and 100 mg/L.
test solutions were uncoloured and clear.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Animals are selected using a handnet, without preference, and randomly assigned to test vessels.
Number of animals : four groups of seven fish.

Study design

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

Test conditions

Hardness:
154 to 159 mg/L of CaCO3.
Test temperature:
between 13 and 17°C but not varying by more than +/-1°C throughout the test.
pH:
between 7.74 and 8
Dissolved oxygen:
between 7.7 and 9.7 mg/L.
Nominal and measured concentrations:
nominal concentrations : 1 ; 10 ; 100 mg/L.
Details on test conditions:
light/dark cycles : 16/8 hours.
duration of test : 96 hours.
during culture, animals were fed twice daily, ceasing at least 24 hours before the experiment starts. Animals were not fed during the test.

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
dissolved

Applicant's summary and conclusion

Validity criteria fulfilled:
yes