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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 10 OCT 1989 to 13 OCT 1989.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 404).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]
EC Number:
225-822-9
EC Name:
2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]
Cas Number:
5102-83-0
Molecular formula:
C36H34Cl2N6O4
IUPAC Name:
2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(2,4-dimethylphenyl)-3-oxobutanamide]
Test material form:
solid: nanoform

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.4-3.5 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.4 ml 0.9% NaCl solution
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of a surgical plaster (Beiersdorf)
- Type of wrap if used: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
4
Irritant / corrosive response data:
1/3 animals showed erythema score 1 one hour after exposure. No other skin reactions were observed at any other time points.
Other effects:
Large yellow discolouration of 3/3 skin sites, which was no longer observable on day two.

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. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No skin reactions occured except a very slight erythema in 1/3 animals one hour after the end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008