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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Sep - 15 Oct 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: M.A.F.F. in Japan 59 NohSan N°4200 (1985)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
446-630-3
EC Name:
-
Cas Number:
181587-01-9
Molecular formula:
C13H9Cl2F3N4OS
IUPAC Name:
5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethanesulfinyl)-1H-pyrazole-3-carbonitrile
Details on test material:
- Name of test material (as cited in study report): RPA 107382
- Analytical purity: 93%
- Lot/batch No.: CDR 9706

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: R. Janvier, Le Genest St. Isle, France
- Age at study initiation: 6 weeks
- Weight at study initiation: 198.2–204.7 g (males) and 164.8–174.4 g (females)
- Housing: rats were housed individually in suspended stainless steel, wire mesh cages.
- Diet: certified Rodent Pellet diet “M 20contrôlé” (Pietrement, Provins, France), ad libitum
- Water: filtered and softened tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20–24
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01 Oct 1997 To: 15 Oct 1997

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: 10%
- Type of wrap if used: the test material was held in contact with the skin with a gauze pad and a bandage (Coheban ™, Laboratories 3 M Sante).

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was eliminated with water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw: 396-406 mg (m) and 330-348 mg (f) (1 mL of water was used to moisten the test substance to ensure good contact with the skin)



Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each animal was weighted on Day -1, 8, 15 and when found dead. Clinical signs were recorded starting on Day 1 (at least twice) and every day through Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: necropsy included macroscopic examination of abdominal and thoracic cavities, major organs and tissues.
Statistics:
For body weights, mean values were calculated for each sex.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No treatment-related mortality occurred during the course of the study. One male animal was found dead within 24 h following the application of the test substance due to excessive tightening.
Clinical signs:
There were no treatment-related clinical signs or behavioural abnormalities. The treatment areas of rats showed no signs of irritation.
Body weight:
The body weight evolution was considered to be unaffected by treatment.
Gross pathology:
At necropsy, there were no gross changes related to treatment. Non-treatment related effects were observed in the lung (moderate haemorrhage) of one male and spleens (white, moderate to marked spots) of two female rats.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified