Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

Test conditions met all validity criteria, given by the mentioned guidelines.

There was less than 5% mortality within the 48-hour settling-in period and <= 10% mortality in the control(s). Dissolved oxygen saturation was greater or equal to 60% throughout the test and pH variation was <= 1.0 units.

The limit test showed that at 10.0 mg test item / L.

The test item did not cause any mortality to Rainbow trout (Oncorhynchus mykiss). The 96h-LC50 is greater than 10.0 mg / L.

There were no mortalities or sublethal effects noted at this concentration after 96 hours. The 96 h NOEC is >= 10.0 mg / L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The limit test showed that at 10.0 mg test item / L did not cause any mortality to Rainbow trout (Oncorhynchus mykiss).