Registration Dossier
Registration Dossier
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EC number: 616-083-7 | CAS number: 74351-78-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-[(2E)-2-[1-({4-[(2E)-2-[2-(5-carboxy-2-chlorophenyl)hydrazin-1-ylidene]-3-oxobutanamido]-2,5-dimethylphenyl}carbamoyl)-2-oxopropylidene]hydrazin-1-yl]-4-chlorobenzoic acid
- EC Number:
- 616-083-7
- Cas Number:
- 74351-78-3
- Molecular formula:
- C30 H26 Cl2 N6 O8
- IUPAC Name:
- 3-[(2E)-2-[1-({4-[(2E)-2-[2-(5-carboxy-2-chlorophenyl)hydrazin-1-ylidene]-3-oxobutanamido]-2,5-dimethylphenyl}carbamoyl)-2-oxopropylidene]hydrazin-1-yl]-4-chlorobenzoic acid
- Details on test material:
- - Batch No.: OP 31
- Purity: commercial grade
- Physical properties: solid; insoluble in water
- Storage conditions: room temperature
- Safety precautions: gloves and face masks
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf
- Age at study initiation: approximately 12 - 14 weeks
- Weight at study initiation: 2300 to 2320 g
- Housing: individually
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) was provided ad libitum.
- Water (e.g. ad libitum): fresh water was provided ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: A control gauze patch was applied to the contralateral flank.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 12-16 cm2
- % coverage:
- Type of wrap if used: gauze patches; were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceuticals Division, Ciba-Geigy Ltd.).
SCORING SYSTEM: Draize Scoring system
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
- Reversibility:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD EU
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