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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-02-11 to 1998-04-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Swiss Federal Department of the Interior

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
426-540-0
EC Name:
-
Cas Number:
2973-59-3
Molecular formula:
C8 H7 Br O3
IUPAC Name:
2-bromo-5-hydroxy-4-methoxybenzaldehyde
Details on test material:
- Name of test material (as cited in study report): T002019
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: solid
- Analytical purity: 91.3% (HPLC purity)
- Impurities: no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 00265786
- Expiration date of the lot/batch: 1998-07-01
- Stability under test conditions: stable
- Storage condition of test material: at room temperature (approx. 20 deg C) away from direct sunlight
- Other: Solubility in water = 70 mg/L; pH of 7.8 at 70 mg/L
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00265786
- Expiration date of the lot/batch: 1998/07/01 (retest date)
- Purity : 91.3% (HPLC)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature at about 20°C, in the dark
- Solubility and stability of the test substance in the solvent/vehicle: solubility in water: 70 mg/L

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: Duplicate samples at the start of test; duplicate samples from the 10 and 22 mg/L at 72 and 48 h, respectively, because of 100% mortality, and duplicate samples from the 1.0, 2.2, and 4.6 mg/L at 96 h.
- Sample storage conditions before analysis: Deep frozen at -20°C until analysis.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution of 40 mg/L nominal was prepared by dissolving 200 mg test substance in 4.95 L deionized water with treatment in an ultrasonic bath for 2x15 minutes, adding the appropriate analytical grade salts for reconstituted water and intensely stirred for 10 min. Dilutions were made for appropriate test concentrations.
- Eluate: not applicable
- Differential loading: not applicable
- Controls: dilution water only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test media of the 22, 10 and 4.6 mg/L test concentrations remained colored solutions throughout the entire test duration or the exposure period, and the test media of the 2.2 and 1.0 mg/L test concentrations remained colorless solutions throughout the entire test duration.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: not applicable
- Source: Zoohaus Schaub, CH-4410, Leistal, Switzerland
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): mean of 10 fish: 2.8 ± 0.2 cm
- Weight at study initiation (mean and range, SD): mean of 10 fish: 0.20 ± 0.07 g
- Method of breeding: obtained from commercial breeder
- Feeding during test: not fed during test

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): yes
- Type and amount of food: Tetra min Hauptfutter, TETRA-Werke,D-49304 Melle, Germany) commercial fish diet, amount unspecified
- Feeding frequency: daily, until one day prior to test
- Health during acclimation (any mortality observed): no mortality

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
none

Test conditions

Hardness:
250 mg/L as CaCO3
Test temperature:
Initial: 22 deg C
Final: 21 deg C
pH:
Initial: 8.1-8.5
Final: 8.0-8.1
Dissolved oxygen:
Initial:8.7-8.9 mg/L
Final: 8.7-8.9 mg/L
Salinity:
not applicable
Nominal and measured concentrations:
Nominal: Control, 1.0, 2.2, 4.6, 10, and 22 mg/L
Mean (geometric) measured: Control, not determined, 0.6, 2.0, 6.2, and 19.8 mg/L.

The analytical mean concentrations in fresh solutions were 90-101% of the nominal concentrations. After 96 h, a concentration-dependent decrease was noted to 80, 38, 19, and 8% for the 22, 10, 4.6, and 2.2 mg/L test concentrations, respectively. Therefore, all reported results are based on the mean (geometric) measured concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass aquaria, 4L test solution
- Aeration: yes, slight
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: no data


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water made from analytical grade salts added to deionized water and aerated to saturation.
- Total organic carbon: no data
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data
- Alkalinity: 0.8 mmol/L
- Ca/Mg ratio: 4:1
- Conductivity: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark
- Light intensity: no data


EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- signs of intoxication and mortality measured at 2.5, 24, 48, 72, and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study
- Test concentrations: not specified
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
6.2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
6.2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: The 95% CL could not be calculated.
Details on results:
- Behavioural abnormalities: fish mainly at the water surface, apathy, tail-dominant swimming, fish at the bottom of the aquarium, tumbling during swimming
- Observations on body length and weight: not applicable
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: none
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
The NOEC, LOEC, LC0, and LC100 were determined directly from the raw data and expressed as nominal and mean geometric measured concentrations. The LC50 was calculated after Finney.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T002019 to zebra fish was determined in a 96-hour static test according OECD guideline 203. Under the conditions of the present study, the 96-h LC50 of the test substance was 3.4 mg T002019/L (mean measured concentration). The 96-h NOEC was 2.0 mg T002019/L (mean measured concentration). The results of the test can be considered reliable without restriction.