Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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