Registration Dossier

Toxicological information

Skin irritation / corrosion

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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
Remarks:
only a 50% aqueous substance preparation was tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
A 50% aqueous preparation of the substance has been applied on the back and ear of rabbits for 20 hours, observations were reported after 24, 48, 72h and 8 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Chemical name (as cited in study report): Perylen-3,4,9,10-tetracarbonsäure-bis-(4-phenylazo)-phenyl-imid
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Average weight at study initiation: 2.9 kg

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
50% aqueous preparation
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back of the animals. The skin on the left side of the exposure are was abraded, the right side remained intact.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
24 h
Remarks on result:
other: could not be scored due to coloration of the skin from the pigment
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: 48 h time point not evaluated
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
72 h
Remarks on result:
other: could not be scored due to coloration of the skin from the pigment
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: 48h time point not evaluated
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: 48h time point not evaluated
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test item was found to have no irritation potential, however the erythema reactions could not be scored due to coloring effects of the test substance. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). Mild edema reactions (score = 1) were reported in all animals at the 24 hours observation time point, abraded skin only. This effect reverted back to normal after 72 hours. On the eighth day the staining effect had cleared; all animals were free of any irritation signs. The test item was found to cause no irritation when applied to intact rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to have no irritation potential, however the erythema reactions could not be scored due to coloring effects of the test substance. Mild edema reactions (score = 1) were reported in all animals at the 24 hours observation time point, abraded skin only. This effect reverted back to normal after 48 hours. On the eighth day the staining effect had cleared; all animals were free of any irritation signs.