Registration Dossier
Registration Dossier
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EC number: 268-083-8 | CAS number: 68002-70-0 This substance is identified by SDA Substance Name: C16-C22 trialkyl glyceride and SDA Reporting Number: 21-001-00.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
- Principles of method if other than guideline:
- A primary dermal irritation study was conducted in rabbits to evaluate skin irritation potential of a formulation containing fully hydrogenated cottonseed oil.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, C16-18
- EC Number:
- 268-084-3
- EC Name:
- Glycerides, C16-18
- Cas Number:
- 68002-71-1
- Molecular formula:
- C9H14O6(CH2)x(CH2)y(CH2)z
- IUPAC Name:
- Tri (C16-18 fatty acyl) glycerol
- Details on test material:
- - Name of test material (as cited in study report): Formulation containing 8.97% fully hydrogenated cottonseed oil (CAS N° 68334-00-9, EC N° 269-804-9); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16-18 ’
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:
- other: Formulation base
- Controls:
- not specified
- Amount / concentration applied:
- 8.97% fully hydrogenated cottonseed oil
- Duration of treatment / exposure:
- 24 h
- Observation period:
- Erythema and edema observed at 2 and 24 h after exposure
- Number of animals:
- Nine
- Details on study design:
- No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: mean of 2 and 24 h
- Score:
- 0.06
- Max. score:
- 8
- Reversibility:
- no data
- Irritant / corrosive response data:
- Not irritating
- Other effects:
- No data
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under test conditions, 8.97% fully hydrogenated cottonseed oil was found to be non-irritating to rabbit skin.
- Executive summary:
In a skin irritation study, a single occlusive patch containing 8.97% fully hydrogenated cottonseed oil was applied to nine rabbits. Sites were evaluated for erythema and edema at 2 and 24 h after exposure. The maximum possible irritation index (PII) score was 8.
The PII of the formulation was found to be 0.06.
Under test conditions, 8.97% fully hydrogenated cottonseed oil was found to be non-irritating to rabbit skin.
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