Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 Jul - 11 Jul 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Testing Methods for New Chemical Substances
Version / remarks:
March 31, 2011, No.0331-7, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare; March 29, 2011, No.5, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry; No. 110331009, Environmental Policy Bureau, Ministry of the Environment, Japan.) VI. Fish acute toxicity test
Deviations:
not specified
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
Adopted: 17 July 1992
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: control, 100 mg/L
- Sampling method: Test solutions for measurement were taken from mid-depth of the test vessel of each test group without agitation (n = 1).

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 0.5917 g of the test substance was weighed with the electronic balance. A stock solution was prepared by mixing the test substance with the dilution water to a volume of 100 mL and then stirred for 48 h with a magnetic stirrer at 23 ± 1 °C. The test solution of 100 mg/L was prepared by diluting the whole volume of the stock solution with the dilution water to make 5 L.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control

Test organisms

Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: medaka
- Strain: Oryzias latipes
- Source: in-house culture
- Length at study initiation: 21 - 26 mm; Mean: 25 mm (n = 20)
- Weight at study termination: 0.06 - 0.16 g; Mean: 0.12 g (n = 20)

ACCLIMATION
- Acclimation period: ≥ 12 d
- Acclimation conditions: same as test with recirculatory filtering system
- Type and amount of food during acclimation: commercial feed, 5 % of body weight
- Feeding frequency during acclimation: 5 times a week
- Health during acclimation: 0 % mortality

FEEDING DURING TEST
- Frequency: no feeding

Study design

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

Test conditions

Hardness:
43 mg CaCO3/L at the initiation of exposure
Test temperature:
23.0 - 23.3 °C
pH:
7.8 - 8.2
Dissolved oxygen:
6.4 - 8.1 mg/L, maintained at ≥ 60% of the air saturation value in all test groups
Nominal and measured concentrations:
nominal: control, 100 mg/L
mean measured: control, 101 mg/L
Details on test conditions:
TEST SYSTEM
- Type: covered with a lid
- Material, size, headspace, Material: glass; inside size ca. 21 cm D x 16 cm W x 23 cm H; headspace: 0 L; fill volume: 5 L
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water (Takarazuka-shi, Hyogo) dechlorinated with charcoal filter
- Total organic carbon: 0.6 mg/L
- Metals: most < LOD except: Fluoride: 0.2 mg/L; Sulfate ion: 34 mg/L
- Pesticides: < LOD
- Chlorine: < LOD
- Alkalinity: 50 mg/L
- Ca/mg ratio: 14 mg/L Ca, 3.1 mg/L Mg
- Intervals of water quality measurement: at initiation and termination of exposure

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 h dark

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable, limit test
- Range finding study: yes
- Test concentrations range finding study: control, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes; 0 % mortality at 100 mg/L in the range-finding test
Reference substance (positive control):
yes
Remarks:
Copper [cupric] sulfate pentahydrate (tested twice a year)

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: 0 %
- Abnormal responses: no abnormal response was recorded. All fish behaved normally.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50 (96 h): 0.45 mg/L
- historical LC50 (96 h): 2.4 ± 1.6 mg/L (mean ± S.D., n = 25)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes