Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 8th to 12th,1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
December 1992
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
July 17th, 1992
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
A limit test was performed in accordance with the test guidelines to demonstrate that the test substance has no toxic effect on the test fish up to the concentration of nominal 200 mg/l. Thus, the only concentration tested was nominal 200 mg/l and a control (test water without addition of the test substance). The analytically determined test substance concentrations in the analysed test medium of 200 mg/l varied in the range from 96 % to 98 % of the nominal value. Therefore, all reported biological results are related to the nominal concentration of the test substance. Medium renewal was performed every 24 hours to keep the concentrations of test item in the test media as constant as possible during the test period.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
7 fishes in control
7 fishes in the test substance concentration

Study design

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

Test conditions

Hardness:
130 mg CaCO3/l
Test temperature:
The test media temperatures ranged from 15.4 to 16.5 °C.
pH:
The measured pH-values in the test media ranged from pH 7.5 to pH 8.6.
Dissolved oxygen:
>= 7.8 mg/l
Nominal and measured concentrations:
Nominal concentration of the test substance = 200 mg/l.
The analytically determined test substance concentrations in the analysed test medium of 200 mg/l varied in the range from 96 % to 98 % of the nominal value.
Therefore, all reported biological results are related to the nominal concentration of the test substance.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
other: LLC
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
In the control and in the 200 mg/l test substance concentration all fish survived until the end of the test. The test medium with 200 mg/l of test substance was intensively coloured by the test substance. Therefore no observation of test fishese in the test medium was possible. At the end of the test, the test fish were placed in control water for observation of symptoms of intoxication. No symptoms of intoxication were observed. Therefore, the 96-hour NOEC, and the 96-hour LC0 of the test substance to Rainbow trout were determined to be at least 200 mg/l test substance. The NOEC might even be higher than this concentration, but concentrations in excess of nominal 200 mg/l test substance have not been tested. The 96-hour LOEC, the 96-hour LC0, the 96-hour LC50 and the 96-hour LC100 were clearly higher than 200 mg/l test substance. These values could not be quantifred, since concentrations in excess of 200 mg/l have not been tested.

Applicant's summary and conclusion

Conclusions:
The test substance has no toxic effects on the fish up to 200 mg/l concentration.