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Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 14 MAR 1978 to 17 MAR 1978.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA-guidelines
Deviations:
not specified
Remarks:
no further information
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]
EC Number:
226-789-3
EC Name:
2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]
Cas Number:
5468-75-7
Molecular formula:
C34H30Cl2N6O4
IUPAC Name:
2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2-methylphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2-methylphenyl)-3-oxobutanamide
Test material form:
cream / paste

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: individually
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm), ad libitum
- Water: tap water, ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped, partially scarified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
24 h
Observation period:
48 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm² gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p.27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 h.
Score:
0
Max. score:
4
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
animal: #1, #4, #6
Time point:
other: 24, 48 h.
Score:
0
Max. score:
4
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
animal: #3, #5
Time point:
other: 24, 48 h.
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 h after exposure.
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 h.
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
48 h after exposure
Remarks on result:
other: intact skin site
Irritant / corrosive response data:
Immediately after exposure erythema score 1 was noted in 4/6 intact skin sites and in 5/6 scarified skin sites. Erythema score 1 persisted in animal #2 until 48 h after exposure. Every other skin response was fully reversible by 48 h. Edema score 1 was noted immediately after exposure in 5/6 intact skin sites and in 4/6 scarified skin sites, fully reversible by 48 h after exposure.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. This conclusion is legitimate even though the applied testing regime differs from today's standard methods, as the observed skin responses were fully reversible in 5/6 animals 48 h after after exposure, which lasted 20 h longer than required by OECD TG 404. The test material contains relevant amounts of Permanent-Gelb G, which is identical to the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 ml test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Very slight erythema were noted in 5/6 animals immediately after end of exposure, fully reversible in 4/6 animals by 48 h after end of exposure. Very slight edema were noted in 5/6 animals immediately after end of exposure, fully reversible by 48 h after end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No. 1272/2008.

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