Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study had been performed in accordance with OECD Giudeline No.:404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cilostazol Starting Material 2
- Physical state: white crystalline powder
- Lot/batch No.: PL2488
- Date of analysys: 2009.03.
- Storage condition of test material: In well closed brown vial at up to 25°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TETRABBIT , Hungary
- Age at study initiation: 10 weeks, adult
- Body weight at the beginning of the study: 2946-3223 g
- Body weight at the end of the study: 3004-3202 g
- Acclimatisation time: 5 days

HUSBANDRY
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70 %
- Air changes (per hr): No data
- Light (hrs dark / hrs light): 12/12
- Housing: Animals were housed individually in metal cages

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- 0.5 g of test item Cilostazol Starting Material 2, in pure state, in a single dose. The test item was moistened sufficiently with water.

VEHICLE
No vehicle was applied
Duration of treatment / exposure:
4 hours
Observation period:
Animals were examined for erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after the patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: appr. 6 cm2
- Type of wrap if used: sterile gauze patch fixed with adhesive hypoallergenic plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with body temperature water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1,24,48,72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The animals' individual mean scores (considering readings at 24, 48, 72 hours after patch removal) for erythema and oedema were 0.00, 0.00 and 0.00 respectively.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No primary irritation symptoms, such as erythema and oedema, or other signs occurred during the observation period.