Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to Basierend auf der Vorschrift der Kommission für Produkt- sicherheit für den Verbraucher der Vereinigten Staaten von Amerika (Federal Regulation (CFR), par. 16, Absatz 15.41)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Basierend auf der Vorschrift der Kommission für Produkt- sicherheit für den Verbraucher der Vereinigten Staaten von Amerika (Federal Regulation (CFR), par. 16, Absatz 15.41)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rabbit,Weiße Neuseeländer

Test system

Type of coverage:
occlusive
Vehicle:
other: none
Duration of treatment / exposure:
24h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0.5
Max. score:
1
Remarks on result:
other: Max. duration: 3 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Results in the table refer to the intact skin.
The abraded sdkin was observed at the same animals at the
same time. The average scores for erythemae was 0.8 and for
edemae 0.
The max. values for erythema was 1 and for edema 0. The max.
duration was < 3 days.
The maximal values at the end of the study: 0.

Applicant's summary and conclusion

Interpretation of results:
other: not classified