Registration Dossier

Administrative data

Endpoint:
eye 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.:405.

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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

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 (EGIS-15331-1)
- Physical state: white crystalline powder
- Lot/batch No.: PL2488
- Date of analysis: 2009.03.
- Re-test date: 2010.03.
- Storage condition of test material: In well-closed brown vial at up to 25°C.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: TETRABBIT , Hungary
- Weight at the beginning of the study: 2936-3178 g
at the end of the study: 3009-3298 g
- Housing: individually in metal cages.
- Diet (e.g. ad libitum): P. Strenghtened Female Hare (Herba) diet produced by AGRIBANDS
- Water (e.g. ad libitum): Animal received tap water from watering bottles ad libitum.
- Acclimatisation time: 6 days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Dosage: 0.1 g of test item in pure state, as a single dose
Duration of treatment / exposure:
The eyes of the animals were not washed out after the application of test item.
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
no removal

SCORING SYSTEM:
by Draize (1977) and OECD 405 (24 April 2002)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
cornea opacity
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0 - 0.33
Max. score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
One hour after the single application of test item into the eye of the rabbits slight redness and slight to moderate discharge were observed in the eye of the test animals.
Other effects:
One hour after treatment some hyperaemic blood vessels (score 1) were observed in all animals. 24 hour after treatment some hyperaemic blood vessels (score 1) were observed in 1 animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, test item applied to the rabbit's eye mucosa, caused cause slight to moderate conjunctival irritant effects, fully reversible within 48 hours. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.