Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 21st, 2002 to November 05th, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
1992
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Yellow 6314-PPT
IUPAC Name:
Yellow 6314-PPT
Test material form:
solid

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
Due to the low water solubility of the test item, a supersaturated dispersion of the test item with a loading rate of 100 mg/l was continuously stirred at room temperature in the dark for 3 hours. Then the dispersion was filtered. Only the undiluted filtrate with the maximum concentration of dissolved test item was used as test medium. Additionally, a control was tested in parallel.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
7 fishes tested per control
7 fishes tested per undiluted filtrate

Study design

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

Test conditions

Hardness:
250 mg CaCO3/l
Test temperature:
14 °C
pH:
7.9
Dissolved oxygen:
8.7 - 9.2 mg/l control
8.7 - 8.9 mg/l undiluted filtrate
Nominal and measured concentrations:
Nominal 100 mg/l as loading rate
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
ln the control and in the undiluted filtrate (loading rate of 100 mg/l) no mortality or other visible abnormalities were determined during the test period of 96 hours. Therefore, the 96-hour NOEC and the 96-hour LC0 of the test item to rainbow trout were determined to be at the loading rate of 100 mg/l. The 96-hour NOEC and the 96-hour LC0 might even be higher, but loading rates in excess of 100 mg/l have not been tested, due to the low water solubility of the test item in the used test water.

Applicant's summary and conclusion

Conclusions:
The test item had no toxic effects on rainbow trout up to its solubility limit in test water.