Registration Dossier
Registration Dossier
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EC number: 209-269-0 | CAS number: 564-20-5
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Maximisation test in humans
- GLP compliance:
- no
Test material
- Reference substance name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
- EC Number:
- 209-269-0
- EC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
- Cas Number:
- 564-20-5
- Molecular formula:
- C16H26O2
- IUPAC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
- Test material form:
- not specified
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 30
- Sex: male and female
- Age: not specified
- Race: not specified
- Demographic information: not specified - Clinical history:
- Not specified
- Controls:
- Not specified
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: not specified
- Vehicle / solvent: petrolatum
- Concentrations: 10%
- Volume applied: not specified
- Testing/scoring schedule: 5 alternate 48-hours period
- Removal of test substance: not specified
EXAMINATIONS
- Grading/Scoring system: not specified
- Statistical analysis: not specified
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 19
- Number of subjects with equivocal reactions: 1 (non reactive at retesting)
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- No reactions were observed.
- Executive summary:
A maximization study was conducted on 30 male and female subjects. The test item at 10% in petrolatum was applied to the same sites on the volar forearms under occlusion. The applications were conducted for five alternate-day 48-hour periods. For the initial patch only, the sites were pretreated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. After a rest period of 10 - 14 days, challenge patches were applied for 48 hours under occlusion to fresh sites on the back. The sites on the left were pretreated for 30 minutes with 2% aqueous SLS
under occlusion, however, the sites on the right were not pretreated with SLS. The sites were read at the patch removal and 24 hours after the patch removal. No reactions were observed.
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