Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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.:406.

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 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The studies were carried out in 2009.

Test material

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LAB-ÁLL Bt. Budapest
- Weight at the beginning of the study: 287-372 g
- Housing: 2-3 animals in 42x42x19 cm macrolon cages
- Diet (e.g. ad libitum): ad libitum,CuniFort Intensive Rabbit Diet Mixture
- Water (e.g. ad libitum): ad libitum, tap water containing 50 mg/100 ml Ascorbic acid.
- Acclimation period: 8 days
- Test group: 10 animals
- Control group: 5 animals
-Sex: male

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: sunflower oil
Concentration / amount:
For the intradermal application 0.1 ml formulated test item was injected at concentrations of 0.01, 0.1, 1 and 5% (w/v).
For the dermal application 0.5 ml formulated test item was applied onto the skin of the animals at concentrations os 10, 25 and 50 % (w/v).
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sunflower oil
Concentration / amount:
For the intradermal application 0.1 ml formulated test item was injected at concentrations of 0.01, 0.1, 1 and 5% (w/v).
For the dermal application 0.5 ml formulated test item was applied onto the skin of the animals at concentrations os 10, 25 and 50 % (w/v).
No. of animals per dose:
In the range finding study: 2-2 animals for intra-dermal and dermal application.
Main study: test groups - 10 animals
control group - 5 animals

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information EU
Conclusions:
Challenge with test item evoked no positive responses in the test animals sensitised previously. At the same time, none of the animals proved to be positive in the control group. The net response value represented an incidance rate of 0% and the net score value of 0.00. According to the results the substance was classified as a non-sensitizer.