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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and sufficient documented

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Principles of method if other than guideline:
500 µl of the test substance was applied to the intact inner surface of one ear per animal; exposure time was 24 hours. The test-substance was fixed by a plaster. The post exposure observation time was 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone
EC Number:
251-178-3
EC Name:
1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone
Cas Number:
32724-62-2
Molecular formula:
C36H38N2O2
IUPAC Name:
1,4-bis[(2,6-diethyl-4-methylphenyl)amino]-9,10-dihydroanthracene-9,10-dione
Details on test material:
Macrolex Blau RR

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
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:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
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:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema 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:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Other effects:
no corrosive effects evident

Any other information on results incl. tables

Score = 0 at any time point (1h, 24h, 72h, 5d, 6d and 7d).


Therefore Macrolex Blau RR is not irritating to the skin

Applicant's summary and conclusion

Interpretation of results:
not irritating
Executive summary:

500 µl of the test substance was applied to the intact inner surface of one ear per rabbit; exposure time was 24 hours. The test-substance was fixed by a plaster. The post exposure observation time was 7 days.

No erythema and no edema was visible. Therefore Macrolex Blau RR is not irritating to the skin.