Registration Dossier
Registration Dossier
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EC number: 287-634-3 | CAS number: 85566-24-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. The test substance was applied under occlusive conditions for 24 h, no experimental 48 h reading performed. Lack of detail on test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure period 24 h, occlusive conditions, no individual scores reported at the 48 h reading time point and lack of detail on test material.
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, C14-18, C14-18-alkyl esters
- EC Number:
- 287-634-3
- EC Name:
- Fatty acids, C14-18, C14-18-alkyl esters
- Cas Number:
- 85566-24-1
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Fatty acids, C14-18, C14-18-alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): [only trade name given]
- Analytical purity: no data
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: 1.8 - 2.4 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated site of the same animal served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
Reading time points: 24 and 72 h - Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Type of wrap if used: occlusive patches (1" x 1" gauze, covered by adhesive tape). Following application of the test material the entire trunk of each animal was covered with an impermeable occlusive wrapping.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values was assumed to be the same as those at 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values was assumed to be the same as those at 24 h
- Irritant / corrosive response data:
- No edema or erythema were seen in any of the animals tested.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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