Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26/11/2016 - 17/02/2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

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:
liquid

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
Samples of the test solutions at the beginning and the end of the renewal period, i.e. when it is freshly prepared and immediately prior to renewal or at the end of exposure are referred to as one set. The two sets of test solutions, one at the beginning of exposure (0 hour) and before renewal at 24 hours and the other after renewal at 72 hours and at the end of exposure (96 hours), were analysed. The test solution of each test group was collected and analysed by gas chromatography/mass spectrometry (GC/MS).

Test organisms

Test organisms (species):
Oryzias latipes
Details on test organisms:
Common name: Medaka

Scientific name: Oryzias latipes

Source: Breeding in the testing facility

Date of starting the collection of eggs: June 20, 2016

Lot No.: 16-M-0620B

Size: Total length: Recommended: 2.3 ± 1.2 cm; Measurements: 2.66 cm (2.39 - 3.03 cm), n=lO
Body weight: Measurements: 0.159 g (0.089- 0.241 g), n=lO; (Measurements of fish in the control group were made post-exposure)

Sensitivity to reference substance: The sensitivity of test fish has been confirmed in each lot by the acute toxicity test of reference substance (CuS04(II)· 5H20, guaranteed reagent). The 96-hour median lethal concentration (96-hour LC50, in anhydrous) is shown below:
- 96-hour LC50 of the lot concerned (Date of performing the acute toxicity test: October 7, 2016)
- 0.26 mg/L (95% confidence limits: 0.10 - 0.40 mg/L)
-The average LC50 value in this laboratory (n = 80, since 1995); Average± standard deviation: 0. 73 ± 0.29 mg/L; Minimum value - maximum value: 0.28 - 1.5 mg/L

Age: Less than a half year after hatching

Medication before acclimation: Applied (New Green F, San-ei Pharmaceutical Co. Ltd.)

Acclimation period: November 24, 2016 - December 5, 2016

Acclimation conditions:
- Water: Dechlorinated water
- Procedure: Flow-through (Biomass loading: 1 g fish/L/day or less)
- Temperature: 24 ± 1 °C
- Dissolved oxygen concentration (D.O.): 80% or more of the saturation
- pH: 6.0-8.5
- Light: Fluorescent light, 16-hour light (1000 lux or less) I 8-hour dark
- Feed: TetraMin, TetraWerke
- Feeding amount: 2% of the body weight/day (approx.) (until 24 hours before exposure)
- Medication during acclimation: Not applied
- Mortality during 7 days before the test: Less than 5%

Study design

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

Test conditions

Hardness:
47 mg CaCO3/L
Test temperature:
23.7 - 24.0
pH:
6.8 - 7.5
Dissolved oxygen:
5.0 - 8.8 mg/L

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
110 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
76.1 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Acute toxicity test of the test substance with Medaka ( Oryzias latipes) was conducted using a binomial method in order to determine the median lethal concentration (LC50) of the test substance for 96-hour exposure. This was determined to be 110 mg/L (95% confidence limits: 76.1 - ∞ mg/L by binomial method).
Executive summary:

Acute toxicity test of the test substance with Medaka ( Oryzias latipes) was conducted using a bonomial method in order to determine the median lethal concentration (LC50) of the test substance for 96-hour exposure. This was determined to be 110 mg/L (95% confidence limits: 76.1 - mg/L)