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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
According to Code of Federal Regulations, title 16, section 1500.41.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Disperse Red 177
IUPAC Name:
Disperse Red 177

Test animals

Species:
rabbit

Test system

Type of coverage:
other: gauze pad
Preparation of test site:
other: intact and abraded sites on clipped dorsum of each animal
Vehicle:
water
Amount / concentration applied:
0.5 g test substance under a gauze pad moistened by 0.5 ml distilled water
Observation period:
Up to 72 h
Number of animals:
6
Details on study design:
OBSERVATION TIME POINTS: 24 and 72 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
None of the animals showed any observable response to treatment thorghout the 72 h observation period.

Any other information on results incl. tables

observation skin time animal no.
1 2 3 4 5 6
erythema intact 24 0 0 0 0 0 0
72 0 0 0 0 0 0
abraded 24 0 0 0 0 0 0
72 0 0 0 0 0 0
oedema intact 24 0 0 0 0 0 0
72 0 0 0 0 0 0
abraded 24 0 0 0 0 0 0
72 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to the rabbit skin.
Executive summary:

Method

Study conducted according to The Code of Fereal Regulations, title 16, section 1500.41.

0.5 g of test substance were applied on both intact and abraded skin of 6 rabbits under a a gauze pad moistened by 0.5 ml of distilled water. Observations were done at 24 and 72 h after application.

Results

No signs of erythema or oedema were noted on both intact and abraded skin. Therefore, test substance was considered as not irritant to rabbit skin.