Registration Dossier
Registration Dossier
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EC number: 205-472-3 | CAS number: 141-24-2
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GCP and Colipa study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: COLIPA
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methyl palmitate
- EC Number:
- 203-966-3
- EC Name:
- Methyl palmitate
- Cas Number:
- 112-39-0
- Molecular formula:
- C17H34O2
- IUPAC Name:
- methyl palmitate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 20- Sex: male and female- Age: no age limit
- Controls:
- No challenge controlPositive control substances: Texapon N28, Sodium-dodecylsulfat, cosmetic alcohol and Aqua demin, phys. NaCl and paraffinoil
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)ADMINISTRATION- Type of application: occlusive - Description of patch: Finn Chamber on Scanpor, 12mm- Volume applied: 70µL- Testing/scoring schedule: 6, 24, 48 and 72h - Removal of test substance: 24hEXAMINATIONS- Grading/Scoring system: Frosch, Kligman, 1979- Undiluted test substance
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects without reactions: 16/20- Number of subjects with slight irritating reactions: 4/20- Number of subjects with slight eschar reactions: 5/20OTHER RESULTS:Erythema Score: 0.21Combined score (Erythema, edema, eschar, etc.): 0.47Positive control results: Mean value over all patients: Erythema: 0.11, Erythema, Edema, Scaling, scissure effects: 0.11
Applicant's summary and conclusion
- Conclusions:
- The test substance shows good skin compatibility and no skin sensitization potential.
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