Registration Dossier

Administrative data

Endpoint:
skin 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:
1987
Report date:
1987

Materials and methods

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

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 (two females and one male)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Results of the study:

  Irritant Effects (Scores)
  24 h   48 h      72 h         Mean scores
 animal   erythema   edema   erythema   edema   erythema   edema   erythema  edema 
 1 (female) 0.0  0.0 
 2 (male) 0 0.0 0.0 
 3 (female) 0 0.0  0.0 

Applicant's summary and conclusion

Executive summary:

500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 3 rabbits (two females and one male) for an exposure period of 4 h. Evaluation of skin irritation was made according to Draize.

In this skin irritation study Acemetacin-tert.-butylester was not irritating to the skin.