Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
and EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
5 ml from all test solutions (except controls and 1,5/1,78) before and after each medium renewal and end of the test.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Rainbow trout.

Study design

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

Test conditions

Hardness:
158 mg CaCO3 / l
Test temperature:
between 13 and 17 °C and do not vary more the than 1 °C
pH:
6.0 - 9.0
Dissolved oxygen:
above 60 % of the air saturation value at the selected temperature
Salinity:
no
Nominal and measured concentrations:

See the table below (any information on materials and methods icl. tables.

Concentration mg / l number of fish
Limit test
control 0 7
treated LS 7
(LS: Limit of solubility obtained from an initial loading rate of 100 mg/L.)

Range finding test
treated LS / 1000 5
treated LS / 100 5
treated LS / 10 5

Definitive test
Group 1 0 10
Group 2 LS / 31.6 10
Group 3 LS / 17.8 10
Group 4 LS / 10.0 10
Group 5 LS / 5.62 10
Group 6 LS / 3.16 10
Group 7 LS / 1.78 10
Group 8 LS 10






Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
2.84 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mortality
Remarks on result:
other: 95 % CL: 1.45-4.56 mg/L
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
2.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mortality
Remarks on result:
other: 95 % CL: 1.45-4.56 mg/L
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
2.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mortality
Remarks on result:
other: 95 % CL: 1.45-4.56 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mortality
Remarks on result:
other: 95 % CL: 1.45-4.56 mg/L
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
4.56 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mortality
Remarks on result:
other: 95 % CL: 1.45-4.56 mg/L
Details on results:
--
Results with reference substance (positive control):
--
Reported statistics and error estimates:
--

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under experimental conditions, the 96-hour LC50 in a semi static system was 2.70 mg/L for rainbow trout.