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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-09-19 - 1995-09-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with analytical monitoring

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
spacing factor was 3.0
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
5-amino-4-({5-amino-3-cyano-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazol-4-yl}disulfanyl)-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile
EC Number:
603-434-4
Cas Number:
130755-46-3
Molecular formula:
C22 H8 Cl4 F6 N8 S2
IUPAC Name:
5-amino-4-({5-amino-3-cyano-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazol-4-yl}disulfanyl)-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile
Details on test material:
- Name of test material (as cited in study report): MB 046307
- Physical state: yellow powder
- Analytical purity: 972 g/kg
- Lot No.: 95-4023
- Storage condition of test material: The test substance was stored in the dark in an air-tight container at room temperature (approximately 20°C).

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent): Dimethylformamide (DMF)
- Concentration of vehicle in test medium (final test solutions including solvent control): 0.1 ml/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Presence of undissolved particles only in higher concentrations (0.22, 0.67, 2.0 mg/L)

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Batch no.: 95T081
- Source: Salmonids hatchery, Charles River Aquatics, 76410 St-Aubin-les-Elbeuf, France
- Age at study initiation: < 1 year
- Length at study initiation (mean, range and SD): 4.4 cm (4.0 - 5.0 cm)
- Weight at study initiation (mean and range, SD): 0.55 g (0.36 - 0.85 g)
- Feeding during test: no

ACCLIMATION
- Acclimation period: a minimum of 12 days
- Acclimation conditions: same as test
- Type and amount of food: commercial trout food pellets
- Feeding frequency: twice daily except during the last 24 hours prior to testing
- Health during acclimation (any mortality observed): no mortality the last 7 days before test initation
- Photoperiod: artificial light, 16 hours light and 8 hours darkness.

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
40 ± 10 mg/L (CaCo3)
Test temperature:
14.0 - 14.5 °C
pH:
7.1 - 7.4
Dissolved oxygen:
8.9 - 9.8 mg/L
Nominal and measured concentrations:
- Nominal test concentrations: control, 0.02, 0.07, 0.22, 0.67, 2.0 mg/L
- Mean measured test concentrations: < 0.01, 0.008, 0.03, 0.21, 0.52, 2.0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material, fill volume: 20 L glass aquaria, 15 L
- Aeration: No aeration during test period.
- Type of flow-through: peristaltic
- Renewal rate of test solution: 50 ml/min
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.08 g/L per 24 hours


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water filtered through active charcoal and diluted with reverse osmosed deionized water
- Conductivity: 110 ± 20 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: 0 h, 48 h, 96 h


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, physical or behavioral alterations after 24, 48, 72, 96 h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3
- Range finding study
- A preliminary test was performed over a period of 72 hours for which the LC50 was estimated to be in excess of the highest tested concentration of 3.0 mg/l. Based on the preliminary test the nominal concentrations were calculated according to a geometric series by a factor of 3

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 2 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: above the visual limit of aqueous solubility
Details on results:
- Behavioural abnormalities: accelerated respiration, lethargy, muscular contractions, partial paralysis
- Other biological observations: pigmentation disorders
- Mortality of control: none
- Other adverse effects control (solvent control): lethargy, partial paralysis

Applicant's summary and conclusion