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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 401); GLP compliant.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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): Disulfide / MB 46307 / RPA 98028 Intermediate of Fipronil (MB 46030).
- Physical state: yellow powder.
- Analytical purity: 97.2 %.
- Purity test date: 23-May-1995.
- Lot/batch No.: 95-4023.
- Storage condition of test material: The test substance was stored in an air-tight, light-resistant container at room temperature.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, St Germain sur L'Arbresle, 69210, France.
- Age at study initiation: 6 weeks.
- Weight at study initiation: weight range from 144 to 151 g for the males and 110 to 117 g for the females.
- Fasting period before study: overnight.
- Housing: individually in suspended stainless steel, wire mesh cages.
- Diet: Certified Rodent Pellet diet A04C (Usine d´Alimentation Rationnelle, Villemoisson-sur-Orge, 91360 Epinay-sur-Orge, France) ad libitum.
- Water: filtered and softened water from the municipal water supply, ad libitum.
- Acclimation period: 6 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C - 24°C.
- Humidity (%): 40% - 70%.
- Air changes (per hr): 10 to 15 air changes per hour (average, not monitored).
- Photoperiod (hrs dark / hrs light): 12-hour light, 12-hour dark cycles.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% methylcellulose in distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days.
- Frequency of observations: one hour after dosing and at least once more on day 1, thereafter, at least once daily.
- Frequency of weighing: once during the acclimatization period, on the day of test substance administration and on days 8 and 15.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
other: There were no treatment-related clinical signs.
Gross pathology:
There were no macroscopic abnormalities at necropsy.

Applicant's summary and conclusion