Registration Dossier
Registration Dossier
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EC number: 220-476-5 | CAS number: 2778-96-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- FINAL REPORT ON THE SAFETY ASSESSMENT OF TEST CHEMICAL.
- Author:
- F. Alan Andersen
- Year:
- 1 997
- Bibliographic source:
- International Journal of Toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the skin irritation potential of test chemical in mice.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hexadecyl palmitate
- EC Number:
- 208-736-6
- EC Name:
- Hexadecyl palmitate
- Cas Number:
- 540-10-3
- Molecular formula:
- C32H64O2
- IUPAC Name:
- hexadecyl palmitate
- Test material form:
- solid
- Details on test material:
- Name of the test chemical:hexadecyl palmitate (cetyl palmitate)Molecular Formula:C32H64O2Molecular Weight:480.856 g/molSubstance Type: OrganicPhysical State: SolidInChI: 1S/C32H64O2/c1-3-5-7-9-11-13-15-17-19-21-23-25-27-29-31-34-32(33)30-28-26-24-22-20-18-16-14-12-10-8-6-4-2/h3-31H2,1-2H3
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: hairless
- Vehicle:
- other: oil (type not specified)
- Controls:
- not specified
- Amount / concentration applied:
- 50% dilution in oil (type not specified)
- Duration of treatment / exposure:
- 2 times a day for 5 days
- Observation period:
- 5 days
- Number of animals:
- 5
- Details on study design:
- no data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 5 days
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Hairless mice did not show any signs of irritation after repeated exposure to the chemical.
Hence, the test material can be considered as not irritating to skin. - Executive summary:
The skin irritation potential of test chemical was assessed in mice. A 50% dilution in oil (type not specified) of test chemical was applied twice daily for 5 days to 5 hairless mice. The mice were observed for signs of irritation.
Hairless mice did not show any signs of irritation after repeated exposure.
Hence, the test material can be considered as not irritating to skin.
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