Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: part of the SNIF file, no further data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: part of the SNIF file, no further data
Rationale for reliability incl. deficiencies:
other: Part of the SNIF file, which was accepted by the UK national authority for NONS

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rabbit (New Zealand White)

Test system

Type of coverage:
semiocclusive
Vehicle:
other: For the purpose of the study the test material was used as supplied.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
1
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
Application of the test material to the intact skin of three
rabbits produced very slight erythema. One treated skin
site appeared normal throughout the study, one other treated
skin site appeared normal at the 24 hour observation and
the remaining treated skin site appeared normal at the 48
hour observation.

Any other information on results incl. tables

Part of the SNIF file, which was accepted by the UK national authority for NONS

Applicant's summary and conclusion

Interpretation of results:
other: not classified