Registration Dossier
Registration Dossier
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EC number: 228-567-1 | CAS number: 6297-03-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997/06/16 - 1997/06/20
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dioctadecyl ether
- EC Number:
- 228-567-1
- EC Name:
- Dioctadecyl ether
- Cas Number:
- 6297-03-6
- Molecular formula:
- C36H74O
- IUPAC Name:
- 1-(octadecyloxy)octadecane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 76410 Saint-Aubin-Les-Elbeuf, France
- Weight at study initiation: average 2.3kg
- Housing: individual housing
- Diet: complete pelleted rabbit maintenance diet Energie H326, COFNA (37000 - TOURS, FRANCE)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
in accordance with the requirements of the 86/609/EEC guideline
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Clipping of fur
- Vehicle:
- other: distilled water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g/rabbit of the test item are applied to the clipped skin.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours after patch removal and extended no more then 14 days to establish reversebility.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk (2.5 x 2.5cm)
- Type of wrap if used: 10cm wide stretch tape (varicose vein tape) fastened by adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): absorbent paper moistured with distilled water
- Time after start of exposure: 4h
SCORING SYSTEM:
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4
Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond
area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean
- Score:
- 0
- Max. 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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