Registration Dossier
Registration Dossier
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EC number: 203-377-1 | CAS number: 106-24-1
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Contact allergy: Predictive testing of fragrance ingredients in humans by|Draize and maximization methods
- Author:
- Marzulli FN and Maibach HI
- Year:
- 1 980
- Bibliographic source:
- Journal of Environmental Pathology and Toxicology 3(5-6): 235-245
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- Marzulli FN and Maibach HI
- Year:
- 2 008
- Bibliographic source:
- RIFM database
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- modified Draize-procedure
Test material
- Reference substance name:
- Geraniol
- EC Number:
- 203-377-1
- EC Name:
- Geraniol
- Cas Number:
- 106-24-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-ol
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 104
- Age: adult - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive, on the arm or upper back
- Description of patch: covered with a square occlusive Band Aid; no perforations.
- Vehicle / solvent: petrolatum or alcohol
- Concentrations: 10% for induction and challenge
- Volume applied: 0.2 ml or 0.2 g
- Testing/scoring schedule: Induction consisted of the application of 10 patches which remained in place for 48-72 hours each. The rest period was 2 weeks. Challenge consisted of the application of a 72 hour patch on a new skin site with a nonirritating concentration of test material.
EXAMINATIONS
- Grading/Scoring system: The scoring was as follows:
1 = erythema;
2 = erythema and induration;
3 = vesiculation;
4 = bulla formation.
A score of grade 2 or greater is evidence of skin sensitization. The results were reported as response fraction or percent positive
(sensitization index) No further information provided.
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 2/73 in alcohol; 0/104 in petrolatum
- Number of subjects with negative reactions71/73 inalcohol; 104/104 in petrolatum
Applicant's summary and conclusion
- Conclusions:
- Geraniol at 10% is sensitising when applied with alcohol, but not with petrolatum.
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