Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 402); 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 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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): 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: 8 to 10 weeks.
- Weight at study initiation: weight range from 276 to 285 g for the males and from 191 to 248 g for the females.
- Fasting period before study: no data.
- 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: 13 days (5 male and 4 female rats) and 20 days (1 female rat).


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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: about 10%
- Type of wrap if used: gauze pads secured with a bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was eliminated using a compress moistened with water.
- Time after start of exposure: 24 h

Duration of exposure:
24 h
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: 14 days
- Frequency of observations: one hour after dosing and at least once more on Day 1, thereafter, at least once daily.
- Frequency of weighing: Days -1, 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 treatment-related mortality occurred during the course of the study.
One animal was found dead within 24 hours following the application of the test substance, but this accidental death was related to the excessive tightening of the gauze bandage used for holding the patch in contact with the skin. This animal was replaced by another animal.
Clinical signs:
There were no treatment-related clinical signs or behavioral abnormalities.
Body weight:
The body weight evolution was considered to be unaffected by the treatment.
Gross pathology:
At necropsy, there were no gross changes related to treatment.

Applicant's summary and conclusion