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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
a off-white powdery solid, without irritating odor

Test solutions

Vehicle:
yes
Details on test solutions:
This study was conducted semi-static system. Preparation method of test solution was calculated from the purity of 99.84 %.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Fish(Zebrafish, Danio rerio) has been used in freshwater toxicity studies, and a large comparable historical database exists; therefore, it was selected for this study.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
Fish in the treatment groups and control group were observed for general symptoms at 3, 6, 24, 48, 72 and 96 hrs after exposure and the mortality was recorded.

Test conditions

Test temperature:
21.7 ~ 22.4 °C
pH:
7.67 ~ 7.93
Dissolved oxygen:
8.37 ~ 8.63 mg/L(94.5 ~ 97.4 %)
Nominal and measured concentrations:
10.0 and 100.0 mg/L.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.006 mg/L
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 0.006 mg/L
Details on results:
Based on the range finding test, limit test was performed in control, 100.0 mg/L nominal concentration. As a result of the stability test, concentration of the test substance(Purity: 99.84 %) in the test solution was carried out 100.0 mg/L. The measured concentrations of the test substance at the 100.0 mg/L were 0.00631 mg/L at 0 hr, 0.00653 mg/L at 48 hrs, 0.00151 mg/L at 96 hrs, based on 0 hr the test substance was not stable at 96 hrs to 23.9 %, so limit test was conducted with semi-static system. As a result of the limit test, The geometric mean of measured concentration of the test substance at the 100.0 mg/L was 0.00604 mg/L for 96 hrs. These result was 0.00604 % about nominal concentration. Therefore, all test results were
determined based on the geometric mean measured concentration.
At 96 hrs after exposure, the total mean size and weight of negative control fish were 2.8 ± 0.1 cm and 0.153 ± 0.030 g(mean±SD), respectively. treatment group fish were 2.8 ± 0.1 cm and 0.155 ± 0.029 g(mean±SD), respectively.
During the exposure period, the water temperature, dissolved oxygen concentration and pH value of test solution were in the ranges of 22.1 ~ 22.8 °C, 6.80 ~ 8.76 mg/L(converted to air saturation value: 77.4 ~ 100.2 %) and 7.37 ~ 8.07, respectively. These values were within the permissible ranges of this study.
LC50 was calculated based on the geometric means measured concentration.

Applicant's summary and conclusion

Conclusions:
During an exposure period, The LC50 was determined to be > 0.00604 mg/L at 48, 96 hrs after exposure. The highest concentration causing no mortality was determined to be ≥ 0.00604 mg/L at 48 and 96 hrs after exposure, respectively. The lowest concentration causing 100 % mortality was determined to be > 0.00604 mg/L at 48 and 96 hrs after exposure, respectively.