Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-07-22 to 2008-08-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

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

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
0; 96 h

Test solutions

Vehicle:
yes
Details on test solutions:
For preparation of the test solution, SPAN80 / Tween 80 (1:3 w/w) was used as solubilizer. The concentration of the vehicle was 200 mg/L.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Weight: 0.23 gLength: 3.1 cmLot: 80509

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no

Test conditions

Hardness:
250 mg/L
Test temperature:
25.1 +/- 1.0 °C
pH:
According to guideline
Dissolved oxygen:
According to guideline
Salinity:
According to guideline
Nominal and measured concentrations:
57 mg/L with 100 mg/L solubiliser = (Span80:Tween 80=1:3)
Details on test conditions:
10 fish per 4 L
Reference substance (positive control):
not specified

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 57 < mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: solubiliser has been applied
Details on results:
- Mortality control: 0 % contanining the vehicle after 96 hours
57 mg/L + Solubiliser 100 mg/L: 0% (24h), 0% (48h), 0% (72h), 0%(96 h)
- Effect concentrations exceeding solubility of substance in test medium: The concentration tested was above the solubility limit of the pure test substance. To achive the exposure concentrations, solvent SPAN 80 Tween 80 = 1:3 (w/w) was used.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 of the test material with solubilizer exceeds 57 mg/L, which is clearly above the limit of water solubility.
Executive summary:

The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 203.

The LC50 of the test material with solubilizer exceeds 57 mg/L, which is clearly above the limit of water solubility.