Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study without defiencies

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: particulates

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)

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:
LC0
Effect conc.:
>= 0.012 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

The test itwem is highly unsoluble in water. The determined water solubiliity was close to the detection limit and decreased over the test period to below the detection limit.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
BAY 43-9006 is not toxic to fish up to the solubility limit.
Executive summary:

A study was performed to assess the acute toxicity of BAY 43-9006 to fish Danio rerio. A group of 10 fish were exposed to the test compound or a control in a limit test.The test concentration was 0.5 mg/L (nominal). The test material was ultrasonified and filtered.

The chemical analysis showed a recovery of <5%, partly below the detection limit. Observations on letality and behaviour of fish were made 2, 24, 48, 72, and 96 hours after start of exposure.

No effects on mortality of abnomal behaviour was observed. Thus, the LC0 was equal or higher than the maximum solubility under the conditions of the test (<0.012 mg/L). Hence, the compound is not toxic to fish.