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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Both eyes of each rabbit were examined within the twenty-four hours prior to the study. The test substance was applied into the conjunctival sac of the left eye of the rabbit. The lids were gently held together for 1-2 sectonds after which the animal was released. The other eye was untreated (control eye). Immediately after the application of the test substance, an assessment of the initial pain reaction of the rabbit was made.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
phenyl N-[2-(phenylsulfanyl)phenyl]carbamate
EC Number:
601-145-8
Cas Number:
111974-73-3
Molecular formula:
C19H15NO2S
IUPAC Name:
phenyl N-[2-(phenylsulfanyl)phenyl]carbamate
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acts as a control
Amount / concentration applied:
100 mg (approx)
Duration of treatment / exposure:
4 d
Observation period (in vivo):
4 d
Number of animals or in vitro replicates:
3
Details on study design:
Both eyes of each rabbit were examined within the twenty-four hours prior to the study. Initially, the test substance was applied into the conjunctival sac of the left eye of one rabbit. The lids were gently held together for 1-2 sectonds after which the animal was released. The other eye was untreated (control eye). Immediately after the application of the test substance, an assessment of the initial pain reaction of the rabbit was made.
After 24 h the irritation was less than severe, so the test substance was applied into the test eyes of the remaining two animals and an assessment of initial pain reaction was made. They eyes were examined and the Draize scale was used to assess the grade of ocular reaction 1-2 hours, 1, 2, and 3 days after application of the test substance. One animal was also observed 4 days after application of the test substance. In addition, as an aid in the assessment of corneal damage, fluorescein staining was used at the 1, 2, 3 and 4-day readings. A modified form of the Kay and Calandra stystem was used to interpret and classify the scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 2 h, 1, 2, 3, 4 d
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 2 h, 1, 2, 3, 4 d
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
other: 2 h
Score:
9.3
Max. score:
20
Reversibility:
fully reversible within: 2 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
other: 1 d
Score:
3.3
Max. score:
20
Reversibility:
fully reversible within: 2 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
other: 2, 3, 4 d
Score:
0
Max. score:
20
Irritant / corrosive response data:
Initial pain reaction (0-5 scale): prac. none (class 1)
Final irritation score (1-8 scale): slight irritant (class 3)

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Kay and Calandra (1962)
Conclusions:
Application into the rabbit eye caused practically no initial pain (class 1 on a 0-5 scale).
Conjunctival effects were seen in all three rabbits and consisted of moderate redness, slight or mild chemosis and slight or moderate discharge. There were no corneal or iridial effects. All signs of irriation had disappeared by two days. Classified as a slight irritatnt (class 3 on a 1-8 scale) to the rabbit eye.