Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-08-30 - 1995-09-01
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 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-dithiobis(5-amino-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:
4,4'-dithiobis(5-amino-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: Test substance was stored in a stoppered container at room temperature, in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples of test solutions (50 ml) were taken for analysis from each bulk preparation at test initiation and from each concentration level (pooled replicates) at the termination of each 24-h cycle. One sample was analyzed.

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Stock solution: Dissolution of 30 mg test substance in 2 ml dimethyl formamide (DMF). Stock solutions of the four lower test substance concentrations were prepared by subsequent dilution with DMF.
- Test solutions: Dilution of the stock solutions
- Chemical name of vehicle: dimethyl formamide (DMF)
- Concentration of vehicle in test medium (final test solution): 0.1 ml/L

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: clone 5 from IRCHA
- Source: Laboratory cultures, Aquatic Ecotoxicology facilities, Rhône Poulenc Agrochimie, Sophia Antipolis, France
- Age at study initiation (mean and range, SD):< 24 hours
- Feeding during test: no

CULTURE CONDITIONS
- Culture conditions: same as test
- Culture medium: dilution water
- Aeration: continuously (air bubbling)
- Type and amount of food: Daphnids were fed a mixture of a fish food suspension, meat extract, yeast suspension, seaweed extract and unicellular green algae (Chlorella vulgaris).
- Feeding frequency: Three times per week

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
ca. 170 mg/L CaCO3
Test temperature:
20.7 - 21.7 °C
pH:
7.8 - 8.0
Dissolved oxygen:
8.2 - 8.5 mg/L
Nominal and measured concentrations:
Nominal test concentrations: control, 0.06, 0.14, 0.31, 0.68, 1.5 mg/L
Mean measured concentrations: < 0.01, 0.04, 0.08, 0.21, 0.48, 1.25 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: covered with plastic sheets to prevent evaporation
- Material, total volume, fill volume: glass, 250 ml, 200 ml
- Renewal rate of test solution (frequency): Each test solution was completely renewed after 24 hours and substituted by a freshly prepared test so!utlon giving two 24-hour cycles of exposure for each treatment level.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dilution water consists of reconstituted water (80% DSW (Dutch Standard Water); 20% LC-oligo medium. Dilution water is prepared from municipal water (reverse-osmosed, de-ionized and filtered through activated charcoal and 0.22 µm filters).
- Conductivity: 562 - 573 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: 0, 24 h

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light/8 hours dark
- Light intensity: 400 - 1500 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilization, behavioral abnormalities

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study: yes
- Test concentrations: control, solvent control, 0.02, 0.2, 2 mg/L
- Results used to determine the conditions for the definitive study: No immobilization was observed in the control group. Immobilization percentages of 10, 20, 60 and 90% were recorded for the daphnids exposed to the solvent, 0.02, 0.2 and 2 mg/l, respectively.

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.2 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 0.14 - 0.28 mg/L
Details on results:
- Immobilization of control: none

Applicant's summary and conclusion