Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 404
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Acemetacin-tert.-butylester

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 (two males and one female)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Results of the study

      Irritant Effects (Score)         
 Animal    24 h 48 h   72 h  Mean scores
 1  Corneal Opacity  0 0.0
   Iritis  0  0  0  0.0
   Redness conjunctivae  0  0  0  0.0
   Chemosis conjunctivae  0  0  0  0.0
 2   Corneal Opacity  0  0  0  0.0
    Iritis  0  0  0  0.0
    Redness conjunctivae  0  0  0  0.0
    Chemosis conjunctivae  0  0  0  0.0
 3   Corneal Opacity  0  0  0  0.0
    Iritis  0  0  0  0.0
    Redness conjunctivae  0  0  0  0.0
    Chemosis conjunctivae  0  0  0  0.0

Applicant's summary and conclusion

Executive summary:

0.1 g of the test substance was administered into the conjunctival sac of in each case one rabbit eye of 3 animals (two males and one females) and after 24 h the treated eyes were rinsed with physiologic saline.

Evaluation of eye irritation was made according to Draize.

According to the classification criteria Acemetacin-tert.-butylester is not irritating to eyes.