Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to scientifically accepted protocol; no GPL; conducted in 1976

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Compound was delivered to the inner-ear skin of 2 rabbits for 24 hours.
Dose: 500 mg/animal
semiocclusive treatment; compound fixed with an adhesive bandage for 24 hours; animals were observed for 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
no further data

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: inner-ear skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 0, 24 and 48 h
Score:
0
Max. score:
8
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0, 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0, 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

No irritation observed at any time point: 0, 24 and 48 h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
No irritation observed at any time point: 0, 24 and 48 h.
Executive summary:

No irritation observed at any time point: 0, 24 and 48 h.