Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-07-24 - 2001-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well-documented GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of the Health of the Government of the United Kingdom

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid
- Lot/batch No.: 1280031
- Storage condition of test material: Room temperature, in the dark until 31 July 2001, thereafter approximately 4ºC in the dark.

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)

Study design

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

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality

Any other information on results incl. tables

There were no mortalities in 20 fish exposed to a test concentration of 100 mg/L for a period of 96 hours. Inspection of the mortality data gave the following results:

 

Time (h)                                LC50(mg/L)                     95% Confidence limits (mg/L)

----------------------------------------------------------------------------------------------------------

3                                          >100                                -

6                                          >100                                -

24                                         >100                                -

48                                         >100                                -

72                                         >100                                -

96                                         >100                                -

 

The results of the definitive study showed the highest test concentration resulting in 0% mortality to be greater than or equal to 100 mg/L, the lowest test concentration resulting in 100% mortality to be greater than 100 mg/L and the No Observed Effect Concentration (NOEC) to be 100 mg/L.

It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.

There were no sub-lethal effects of exposure observed in 20 fish exposed to a test concentration of 100 mg/L for a period of 96 hours. The test preparations were observed to be clear colourless solutions throughout the definitive study.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test material to the freshwater fish rainbow trout (Oncoryhnchus mykiss) has been investigated and gave a 96-Hour LC50 of greater than 100 mg/L. Correspondingly the No Observed Effect Concentration was 100 mg/L.