Registration Dossier
Registration Dossier
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EC number: 204-371-1 | CAS number: 120-12-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to national guideline, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Code of Federal Regulations (Title 16, Section 1500.41) [Consumer Product Safety Commission USA]
- Principles of method if other than guideline:
- Method: FDA method, 10% suspension in 0.5% carboxymethyl cellulose solution; 24 h, occlusive on normal and scarifized skin; skin scoring according to Draize
- GLP compliance:
- no
Test material
- Reference substance name:
- Anthracene
- EC Number:
- 204-371-1
- EC Name:
- Anthracene
- Cas Number:
- 120-12-7
- Molecular formula:
- C14H10
- IUPAC Name:
- anthracene
- Details on test material:
- purity: 'Anthrazen reinst'
Product No. 110 147
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved (intact and abraded)
- Vehicle:
- other: 0.5% carboxymethylcellulose (CMC)
- Controls:
- other: vehicle-treated skin site
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL CMC suspension
- Concentration (if solution): 10 % (w/v)
VEHICLE
- Concentration (if solution): 0.5 % (w/v) in water - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h post-application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 squ. inch
- Type of wrap if used: impervious material (rubberized cloth)
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize numerical scoring system for grading irritation effects (erythema and edema)
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- for 6 animals and two time points
- Time point:
- other: 14 h + 72 h post-application
- Score:
- 0.79
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Slight erythemas and/or swelling in 6/6 rabbits:
Individual scores for erythema = 0 and 1 (maximum score 4);
individual scores for edema = 0 and 1 (maximum score 4).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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