Registration Dossier
Registration Dossier
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EC number: 604-075-6 | CAS number: 138401-24-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 March 1994 to 28 March 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guidelines for testing of chemicals and with regulatoy texts published in the french "Journal Officiel" on 1 February 1982; 9 June 1992 and 5 April 1971
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- GLP compliance:
- yes
Test material
- Reference substance name:
- [1,1’-Biphenyl]-2-carbonitrile, 4’-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-
- IUPAC Name:
- [1,1’-Biphenyl]-2-carbonitrile, 4’-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-
- Reference substance name:
- 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-ene-3-yl)methyl)(1,1'-biphenyl)-2-carbonitrile
- EC Number:
- 604-075-6
- Cas Number:
- 138401-24-8
- Molecular formula:
- C25H27N3O
- IUPAC Name:
- 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-ene-3-yl)methyl)(1,1'-biphenyl)-2-carbonitrile
- Details on test material:
- - Name of test material (as cited in study report): SR47563
- Physical state: powder
- Lot/batch No.: 3SNP022
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand hybrid
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Les Dombes, Romans, 01400 Chatillons sur Chalaronnes, France
- Age at study initiation: 6 weeks old approximately
- weight : 2.5 kg
- Diet: ad libitum
- Water: free access
- Acclimation period: 2 weeks
- Housing: singly in wire mesh bottom, stainless steel cages. The space allocated 0.30 m2 x 39 cm
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): 50-85%
- Air changes (per hr): 10-11 per hour without recirculation
- Photoperiod (hrs dark / hrs light): 12/24 hours
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: non-treated skin area
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg - Duration of treatment / exposure:
- 24h
- Observation period:
- 24 (D2, 1 hour after patch removal), 48 (D3), 72 (D4) and 96h (D5) after application of the compounds
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 14 cm2
- % coverage: no data
SCORING SYSTEM:
Draize technique
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.5
- Max. score:
- 8
- Reversibility:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- SR 47563 was slightly irritant to the skin (2>PCII>=0.5)
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