Registration Dossier
Registration Dossier
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EC number: 266-946-3 | CAS number: 67701-28-4 This substance is identified by SDA Substance Name: C8-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 01-001-00.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source (documentation insufficient for assessment)
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
- Principles of method if other than guideline:
- Undiluted palm oil was evaluated in a single-insult occlusive patch test on rabbits. Scoring of the effects was done 2 and 24 h post application.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd.
- EC Number:
- 266-948-4
- EC Name:
- Glycerides, C16-18 and C18-unsatd.
- Cas Number:
- 67701-30-8
- IUPAC Name:
- Glycerides, C16-18 and C18-unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Palm oil (CAS N° 8002-75-3, EC N° 232-316-1); under the SDA nomenclature; the name of this substance is 'Glycerides, C16-18 and C18-unsatd.'
- Substance type: Triglycerides of vegetable origin
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- None
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- No data
- Observation period:
- 2 and 24 h post application
- Number of animals:
- Nine
- Details on study design:
- No data
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.22
- Max. score:
- 8
- Reversibility:
- no data
- Irritant / corrosive response data:
- At 2 h post application, five rabbits had an irritation score of 0 and the remaining four had a score of 0.5. At 24 h post application, one rabbit had a score of 0.5 and the remaining rabbits had a score of 0.
- Other effects:
- No data
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, palm oil was found to be practically non-irritating to rabbit skin.
- Executive summary:
Undiluted palm oil was evaluated for skin irritation potential in a single-insult occlusive patch test on rabbits. Scoring of the effects was done 2 and 24 h post-application.
Slight effects were observed on 4 rabbits and 1 rabbit after 2 and 24 h post-treatment, respectively. The PDII was found to be 0.22.
Under the test conditions, palm oil was found to be practically non-irritating to rabbit skin.
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