Registration Dossier
Registration Dossier
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EC number: 939-270-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984-05-30 - 1984-06-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well conducted study similar to guideline (limited documentation; 2 hours exposition, occlusive coverage, 5 animals, 48-hours observation period)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation, 2 hours treatment, occlusive coverage, 5 animals, 48-hours observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-hexyldecyl esters
- EC Number:
- 309-832-1
- EC Name:
- Fatty acids, C16-18, 2-hexyldecyl esters
- Cas Number:
- 101227-09-2
- IUPAC Name:
- 101227-09-2
- Details on test material:
- - Name of test material (as cited in study report): Isohexadecylstearat
No further details provided
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 4976 g
No additional details provided.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin size of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 2 hours
- Observation period:
- not specified
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: 3 cm x 30 cm dorsal skin area
- Type of wrap if used: linen patch under an occlusive dressing.
REMOVAL OF TEST SUBSTANCE
Not specified
SCORING SYSTEM:
Not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all treated animals
- Time point:
- other: 24-48 hours
- Score:
- ca. 0.2
- Max. score:
- 4
- Reversibility:
- other: not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all treated animals
- Time point:
- other: 24-48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- It is reported that a slight erythema (score assumed to be 1) was observed only in one animal immediately after treatment up to 48 hours thereafter. No further skin reaction was observed in the remaining 4 animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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