Registration Dossier

Administrative data

Endpoint:
skin 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:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not specified
Duration of treatment / exposure:
4h
Observation period:
1, 24, 48, 72h
Number of animals:
3 male

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1,24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1,24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, IN 00078280, was found to be a non-irritant to the skin of rabbits with a Primary Irritation Index score of 0.
Executive summary:

A. Title Primary Dermal Irritation Study of IN 00078280 in Rabbits

B. Objective The purpose of this study was to determine the potential irritant and/or corrosive effects of IN 00078280 on the skin of rabbits.

C. Methods The test article, IN 00078280, was applied to one site on the clipped dorsal trunk of three male New Zealand White rabbits. The total exposure period was 4 hours. Observations for dermal irritation and corrosivity were recorded for each site 30-60 minutes after patch removal and at 24, 48 and 72 hours after unwrap. Grading of irritation was according to the method of Draize.

D. Results The Primary Irritation Index (PII) was calculated and determined to be 0.

E. Conclusion Under the conditions of this study, IN 00078280, was found to be a nonirritant to the skin of rabbits with a Primary Irritation Index score of 0.