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Ecotoxicological information

Short-term toxicity to fish

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Link to relevant study record(s)

Reference
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
Qualifier:
according to guideline
Guideline:
other: Testing Methods for New Chemical Substances (Nov 21, 2003, No.1121002, Pharmaceutical and Food Safety Bureau, MHLW; Nov 13, 2003 No.2, Manufacturing Industries Bureau, METI; No.031121002, Environmental Policy Bureau, Ministry of the Environment)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Guidance Document No. 23 (Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures), 2000
Deviations:
not applicable
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: nominal 100 mg/L and control
- Sampling intervals: test start and end
- Sampling method: combined samples taken from the middle layer of the test solution in replicate vessels
- Sample storage conditions before analysis: none
Vehicle:
no
Details on test solutions:
The test material and dilution water were mixed to produce nominal 100 mg/L . The dispersions were stirred by magnetic stirrer for about 48 hours to prepare the test solution. Undissolved test material was not removed.
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Medaka
- Source: Kurume laboratory, Chemicals Evaluation and Research Institute, Japan, 3-2-7 Miyanojin, Kurume-shi, Fukuoka 839-0801, Japan
- Age at study initiation: 5 months
- Length at study initiation: 2.3 ± 1.2 cm
- Feeding during test: none

ACCLIMATION
- Acclimation period: 11 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: feed mixture for carp (2C)
- Feeding frequency: not indicated; no feeding for 24 hours before start of exposure
- Health during acclimation (any mortality observed): no mortality during the 7 days before start of exposure; no external disinfection of the test organisms
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
28 mg/L (as CaCO3)
Test temperature:
23.9-24.8°C
pH:
7.9-8.1
Dissolved oxygen:
8.1-8.4 mg/L (>60% of saturation concentration)
Salinity:
not applicable
Nominal and measured concentrations:
nominal: 100 mg/L
measured concentrations at test start and end: <0.022 mg/L (LOQ)
Details on test conditions:
TEST SYSTEM
- Test vessel: 3 L glass tanks (diameter: 16 cm, depth: 17 cm), covered with lids
- Aeration: yes
- No. of organisms per vessel: 4
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: approx. 0.24 g/L (calculated from the mean (n=8) control fish body weight at test end)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water. Chemical characteristics are measured regularily
- Culture medium different from test medium: no
- Intervals of water quality measurement:
temperature, dissolved oxygen and pH: start of the exposure and every 24 hours
appearance of the test solutions: observed at test start and end

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: artificial light (white fluorescent lamp), 16 hours light/8 hours darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality and visible abnormality were observed at 3, 24, 48, 72 and 96 hours after the start of exposure. The total length and body weight of the control group fish were measured after the end of the exposure.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: nominal 100 mg/L (prepared as for the main test).
- Results used to determine the conditions for the definitive study: no effects were observed
Reference substance (positive control):
yes
Remarks:
copper sulphate
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 (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality and sub-lethal effects
Details on results:
- Behavioural abnormalities: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Effect concentrations exceeding solubility of substance in test medium: none

The test solution was a white suspension with floating substance and suspended precipitations during the whole exposure.
Results with reference substance (positive control):
The 96-hour LC50 was 0.64 mg/L (normal range in this laboratory: 0.14 to 0.97 mg/L)
Validity criteria fulfilled:
yes
Remarks:
No mortality in the control; concentration of dissolved oxygen >60% saturation

Description of key information

96-h LC50 >100 mg/L (nominal) for Oryzias latipes (OECD 203)

Key value for chemical safety assessment

Additional information

The results indicate that the test material is not toxic to Medaka up to the limits of its water solubility and a NOEC and thus a PNEC cannot be determined.