Registration Dossier
Registration Dossier
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EC number: 290-823-3 | CAS number: 90268-23-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 19 JUL 1988 to 22 JUL 1988.
- 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:
- 1 988
- Report date:
- 1988
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
- Reference substance name:
- Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.
- EC Number:
- 290-823-3
- EC Name:
- Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.
- Cas Number:
- 90268-23-8
- Molecular formula:
- C32H26Cl2N6O4 // C33H28Cl2N6O5 // C34H30Cl2N6O6
- IUPAC Name:
- 2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-[2-oxo-1-(phenylcarbamoyl)propyl]diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-3-oxo-N-phenylbutanamide; 2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(4-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-3-oxo-N-phenylbutanamide; 2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(4-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(4-methoxyphenyl)-3-oxobutanamide
- Test material form:
- solid: nanoform
Constituent 1
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: 2.0-2.6 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:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 1.0 ml polyethylene glycol 400.
VEHICLE
- Lot/batch no.: Ch-B 2322, Riedel-de Haen - 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 water
- Time after start of exposure: 4h
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:
- No edema was observed during the study. One hour after exposure 1/3 animals showed erythema score 1. 24 h after exposure no other effects were observed. 48 h and 72 h after exposure no effects were observed.
- Other effects:
- One hour and 24 h after exposure every animal showed yellow discolouration of skin sites, which was no longer observable 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:
- The test material is not irritating to skin under these test conditions.
- Executive summary:
The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404 and did not cause any signs of skin irritation besides very slight erythema in 1/3 animals one hour after exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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