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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June12, 2019 - October 14, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: 120001168816
- Expiration date of the batch: May 12, 2020
- Purity test date: May 13, 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Tightly closed in cool, dry, well ventilated area, refrigerator at 2-10°C
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from all test concentrations
- Sample storage conditions before analysis: Deep frozen (<= -18°C)
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Stock culture
- Length at study initiation: 1.22-1.99 cm, mean: 1.64 cm
- Weight at study initiation: 0.0232-0.0838 g/fish, mean: 0.0520 g/fish

FEEDING DURING TEST
- Fish were not fed during the test period
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
164.3 mg/ CaCO3
Test temperature:
23.2 - 23.4°C
pH:
7.4 - 7.6
Dissolved oxygen:
94 - 107% of air saturation
Conductivity:
808 µS/cm²
Nominal and measured concentrations:
Nominal: 3.13, 6.25, 12.5, 25.0 and 50.0 mg/L
Measured: 2.59, 5.76, 11.4, 21.4 and 45.2 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 3.8L glass vessels
- Type: open
- Material, size, headspace, fill volume: Glass (covered with glass lids), 2.0 L fill volume, depth about 9 cm
- Aeration: Permanent
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.182 g/L

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: Local tap water
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 14 h light / 10 h dark
- Light intensity: 100-1000 lx; range: 455-575 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Effects on appearance, size and behaviour were observed daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.0
- Range finding study : yes
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
23.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
29.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities:
- Biological observations: Lying on the bottom of the vessel, loss of equilibrium, swimming upside down, reduced swimming activity compared to the control, changes in ventilation rate and respiration
- Mortality of control: 0
Reported statistics and error estimates:
Weibull & Probit analysis was used for the determination of the LC50.
The NOEC and the LOEC were determined Step-down Cochran-Armitage Test Procedure.
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the test, the LC50 was determined to be 23.1 mg test item /L. As the test concentrations did not remain within the range of +/- 20% of the nominal concentration, the LC50 value is based on the geometric mean measured values.

Description of key information

LC50 (zebrafish), based on mortality: 23.1 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
23.1 mg/L

Additional information

A 96-hour acute toxicity study in Zebrafish (Danio rerio) conducted under static conditions reported an LC50 of 23.1 mg/l (geometrical mean measured concentrations) based on mortality.