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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (non-GLP, occlusive dressing, no washing after 24 h of exposure)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
secondary source
Title:
C.I. Pigment Brown 24
Author:
OECD
Year:
2002
Bibliographic source:
SIDS Initial Assessment Report for SIAM 15

Materials and methods

Principles of method if other than guideline:
Before OECD Guideline 404 was established in 1982, skin irritation was tested according to the acknowledged Draize test method.
An amount of 0.5 mL of test material was applied to a skin area of 2.5 x 2.5 cm under occlusive conditions for 24 hours. The application site was either intact or scarified. The application site on the intact skin was located dorsally whereas the area of scarified skin was located on the left side. Skin findings were assessed after 24 hours, 48 hours, 72 hours and after 8 days. The assessment of the findings was based on the Federal Reg. 38, No. 187, Para. 1500.41, page 27029 (1973).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.50 kg
- Diet: Sniff

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
Concentration: 50 %
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6 (2 males, 4 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 * 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72 h/8 d
Score:
0
Max. score:
4
Remarks on result:
other: Evaluation of erythema after 24 and 72 hours not possible due to substance related staining. No erythrema noted at day 8.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

Abraded skin:

Evaluation of erythema impossible after 24 and 72 h due to colouring of skin, no erythema after 8 days but scaling in 3/6 rabbits. Edema in 4/6 rabbits after 24 h, no edema after 72 h or 8 d.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met