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Diss Factsheets

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:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Test was performed on six female rabbits. Approx 24 h before application of the test substance, the hair was removed from areas approx 7 x 13 cm on both flanks of each animals. Only animals in which the epidermis appeared to be normal were used. The test substance was moistened to a paste with a small amount of olive oil and was then applied to each of the test sites. A single four-hour applications was made to the left flank and a total of five four-hour applications on consecutive days was made to the right flank. The Draize scale was used to assess the degree or erythemea and oedema at the application sites.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
phenyl N-[2-(phenylsulfanyl)phenyl]carbamate
EC Number:
601-145-8
Cas Number:
111974-73-3
Molecular formula:
C19H15NO2S
IUPAC Name:
phenyl N-[2-(phenylsulfanyl)phenyl]carbamate
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Olive oil (small amount)
Controls:
no
Amount / concentration applied:
500 mg (approx)
Duration of treatment / exposure:
4 h
Observation period:
10 days
Number of animals:
6
Details on study design:
Approx 24 h before application of the test substance, the hair was removed from areas approx 7 x 13 cm on both flanks of each animals. Only animals in which the epidermis appeared to be normal were used. The test substance was moistened to a paste with a small amount of olive oil and was then applied to each of the test sites. A single four-hour applications was made to the left flank and a total of five four-hour applications on consecutive days was made to the right flank.
The Draize scale was used to assess the degree or erythemea and oedema at the application sites.
Single-application sites: 30 min, 60 min, 1, 2, 3 days after removal of the dressings.
Repeated-application sites: 1 h after the removal of the dressings after each application and 1, 2, 3, 7 and 10 days after removal of the dressings following the final application. Any other signs of skin irritation were also noted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
single application
Basis:
mean
Time point:
other: 30 - 60 min, 1, 2, 3 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 2 d
Remarks on result:
other: Mean score is 0,3 (6 animals)
Irritation parameter:
edema score
Remarks:
single application
Basis:
mean
Time point:
other: 30-60 min, 1, 2, 3 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 2 d
Remarks on result:
other: Mean score is 0,1 (6 animals)
Irritation parameter:
erythema score
Remarks:
repeated applications
Basis:
animal: 1-6
Time point:
other: 1 application
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Very slight erythema
Irritation parameter:
erythema score
Remarks:
repeated applications
Basis:
animal: 1,2,4
Time point:
other: 2 applications
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Very slight erythema
Irritation parameter:
erythema score
Remarks:
repeated applications
Basis:
animal: 3,5,6
Time point:
other: 2 applications
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Well defined erythema
Irritation parameter:
erythema score
Remarks:
repeated applications
Basis:
animal: 1
Time point:
other: 3 applications
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Very slight erythema
Irritation parameter:
erythema score
Remarks:
repeated applications
Basis:
animal: 2-4
Time point:
other: 3 applications
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Well defined erythema
Irritation parameter:
erythema score
Remarks:
repeated applications
Basis:
animal: 5, 6
Time point:
other: 3 applications
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Moderate to severe erythema
Irritation parameter:
erythema score
Remarks:
repeated applications
Basis:
animal: 1-3
Time point:
other: 4 and 5 applications
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Well defined erythema
Irritation parameter:
erythema score
Remarks:
repeated applications
Basis:
animal: 4-6
Time point:
other: 4 and 5 applications
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Moderate to severe erythema
Irritation parameter:
edema score
Remarks:
repeated applications
Basis:
animal: 1-4, 6
Time point:
other: 1 application
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Very slight oedema
Irritation parameter:
edema score
Remarks:
repeated applications
Basis:
animal: 5
Time point:
other: 1 application
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Slight oedema
Irritation parameter:
edema score
Remarks:
repeated applications
Basis:
animal: 1-3, 5-6
Time point:
other: 2 applications
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Slight oedema
Irritation parameter:
edema score
Remarks:
repeated applications
Basis:
animal: 4
Time point:
other: 2 applications
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Very sllight oedema
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 3, 4, 5 applications
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Slight oedema
Other effects:
Additional observations of desquamation and thickening were seen during the study.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize scale
Conclusions:
Signs of slight irritation were seen after a single four-hour application to rabbit skin (fully reversible within 2 days)
Signs of mild to moderate irritation were seen after repeated (x5) four-hour applications to rabbit skin (fully reversible within 7 days)