Registration Dossier
Registration Dossier
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EC number: 208-873-1 | CAS number: 544-60-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: both test sites clipped, one abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 48 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1.5x1.5 inch
- Type of wrap if used: plastic trunk bands
REMOVAL OF TEST SUBSTANCE
- Washing: all test sites were washed with solvent
- Time after start of exposure: 4 hours after application, after the first reading
SCORING SYSTEM:
The primary irritation index is calculated by adding the values for erythema or eschar fonnation, and ederna at 4 I 24 and 48 hours on intact and abraded skin (12 values) and dividing by six to obtain an individual score on each rabbit.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h / 48 h
- Score:
- 0.04
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h / 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 h / 48 h
- Score:
- 0.04
- Max. score:
- 8
- Reversibility:
- fully reversible within: 48 h
Applicant's summary and conclusion
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