Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit interpretation of study results
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The eye irritation test was performed using 9 rabbits. The eye irritation test was performed using 9 rabbits, determined to be free of eye defects and irritation. A 0.1mL aliquot of test material was instilled into the lower conjunctival sac of the right eye. The eyelids were held closed for 1-2 seconds. The left eye served as the untreated control. The eyes were examined at 24, 48, and 72 hours post-treatment.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): P-1601 (Oxazolidine E, BIOBANTMCS-1246 Antimicrobial)
- Physical state: Light yellow colored liquid
- Analytical purity: 94.52%
- Lot/batch No.: M4590
- Stability under test conditions: Not reported assumed to be stable under normal storage conditions

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 3.0 ± 0.5 kg
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS: Not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
A 0.1mL aliquot of test material was instilled into the lower conjunctival sac of the right eye. The left eye served as the untreated control.
Duration of treatment / exposure:
The eyelids were held closed for 1-2 seconds. The eyes of the first six rabbits were not treated further after the instillation of the test material, but the eyes of the three remaining rabbits were irrigated with 50mL of lukewarm tap water after a 20-30 second exposure to the test material.
Observation period (in vivo):
24, 48, and 72 hours post-treatment and on the 7th day.
Number of animals or in vitro replicates:
9
Details on study design:
The eye irritation test was performed using 9 rabbits, determined to be free of eye defects and irritation. A 0.1mL aliquot of test material was instilled into the lower conjunctival sac of the right eye. The eyelids were held closed for 1-2 seconds. The left eye served as the untreated control.

The eyes of the first six rabbits were not treated further after the instillation of the test material, but the eyes of the three remaining rabbits were irrigated with 50mL of lukewarm tap water after a 20-30 second exposure to the test material.

The eyes were examined at 24, 48, and 72 hours post-treatment. At 72 hours and on the 7th day, a drop of sodium fluorescein (0.24%) was placed on the cornea of each treated eye. The excess fluorescein was flushed with sterile saline, and the eye was examined under a UV light for corneal lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
68
Remarks on result:
other: Unwashed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
44
Remarks on result:
other: Washed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
55
Remarks on result:
other: Unwashed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
59
Remarks on result:
other: Washed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
55
Remarks on result:
other: Unwashed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
59
Remarks on result:
other: Washed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 d
Score:
29
Remarks on result:
other: Unwashed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 d
Score:
46
Remarks on result:
other: Washed
Irritant / corrosive response data:
Cornea:
Time Treatment Opacity Area
24hr Unwashed 1.5 4
24hr Washed 2.7 4
48hr Unwashed 1.8 3.3
48hr Washed 2.0 4
72hr Unwashed 1.8 3.3
72hr Washed 2.0 4
7day Unwashed 1.0 2.0
7day Washed 1.7 2.7

Iris:
Time Treatment Score
24hr Unwashed 1
24hr Washed 1
48hr Unwashed 0.8
48hr Washed 1
72hr Unwashed 0.8
72hr Washed 1
7day Unwashed 0.7
7day Washed 1

Conjunctiva:
Time Treatment Discharge
24hr Unwashed 1
24hr Washed 1
48hr Unwashed 0.8
48hr Washed 1
72hr Unwashed 0.8
72hr Washed 1
7day Unwashed 0.7
7day Washed 0.7

Redness:
Time Treatment Redness
24hr Unwashed 1.7
24hr Washed 1.7
48hr Unwashed 1.8
48hr Washed 3.0
72hr Unwashed 1.8
72hr Washed 3.0
7day Unwashed 0.8
7day Washed 1.3

Chemosis:
Time Treatment Chemosis
24hr Unwashed 1.3
24hr Washed 2.3
48hr Unwashed 1.8
48hr Washed 3.0
72hr Unwashed 1.8
72hr Washed 3.0
7day Unwashed 1.5
7day Washed 1.7



Other effects:
On the 7th day, the irritation was still present in 3/6 unwashed and 2/3 washed eyes.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the eye irritation scores, the material was considered to be an eye irritant.
Executive summary:

The eye irritation test was performed using 9 rabbits, determined to be free of eye defects and irritation. A 0.1mL aliquot of test material was instilled into the lower conjunctival sac of the right eye. The eyelids were held closed for 1-2 seconds. The left eye served as the untreated control.

The eyes of the first six rabbits were not treated further after the instillation of the test material, but the eyes of the three remaining rabbits were irrigated with 50mL of lukewarm tap water after a 20-30 second exposure to the test material.

The eyes were examined at 24, 48, and 72 hours post-treatment.
 At 72 hours and on the 7thday, a drop of sodium fluorescein (0.24%) was placed on the cornea of each treated eye. The excess fluorescein was flushed with sterile saline, and the eye was examined under a UV light for corneal lesions

Within the first 24 hours, the test material had produced irritation to the cornea, iris, and conjunctiva of washed and unwashed eyes. The severity of the irritation persisted up to 72 hours in 5/6 unwashed and 3/3 washed eyes. On the 7th day, the irritation was still present in 3/6 unwashed and 2/3 washed eyes.

Based on the eye irritation scores, the material was considered to be an eye irritant.