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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Feb - 17 Feb 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxybenzamide
- Analytical purity: 97.4%
- Lot/batch No.: 08466/0013

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan/Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approx. 9 -13 weeks
- Body Weight at study initiation: 245 - 281 g for males and 205 - 223 g for females
- Fasting period before study: ad libitum
- Housing: Caged individually in polycarbonate cages on low dust wood granulate bedding.
- Diet (e.g. ad libitum): standard diet for rats and mice "Provimi Kliba 3883.0.15 Maus/Ratte Haltung, Kaiseraugst Switzerland", ad libitum
- Water (e.g. ad libitum): ad libitum tap water from polycarbonate bottles, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 2005-02-03 to 2005-02-17

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10% (6.0 cm x 5.0 cm = 30.0 cm²)
- Type of wrap if used: Test material was placed on a wet gauze-layer of a ,,Cutiplast® steril" coated with air-tight ,,Leukoflex®"; gauze strip which was placed on the rat's back and secured in place using ,,Peha®-Haft" cohesive stretch tape (8 cm x 23 cm) and additionally covered with a "Lomir biomedical Inc rat jacket" and connnected with a safety pin to the stretch tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with tepid water using soap and gently patting the area dry
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw; 21.8 - 25 mg/cm² for males and 18.2 - 19.8 mg/cm² for females
- Constant volume or concentration used: yes
- For solids, paste formed: no, test substance was applied via a wet gauze layer.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Clinical signs and mortality rates were determined several times on the day of application and subsequently at least once daily for an observation period of at least 14 days.
- Mortality and in the event of symptoms occurring, nature, duration and intensity were recorded individually.
- Body weight and bodyweight gain were checked weekly until the end of the study.
Terminal procedures: Animals which died or were killed in moribund state were weighed (except on day of application) and dissected as soon as possible, and examined macroscopically. The surviving animals were sacrificed by carbon dioxide asphyxiation at the end of the study, dissected and
examined macroscopically.
Statistics:
Means and standard deviations were calculated for bodyweights
The LD50 value was calculated with the aid of a software program according to Spearman, Karber (D. J. Finney; Statistical method in biological assay, 2nd Edition, Griffin, London, 524-530; 1971). The algorithm was taken from L. Sachs (Angewandte Statistik, 6th Edition 1984, pp. 178 ff.).
Where calculation of the LD50 using the software program was not possible or meaningful, an assessment was made based on the applied dose
and dose-response curve, respectively.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study
Clinical signs:
Clinical signs of toxicity were not observed during the 14-day observation period
Body weight:
There were no toxicological effects on body weight or body weight development in males and females.
Gross pathology:
The necropsies performed at the end of the study revealed no specific findings

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
CLP: not classified

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