Registration Dossier
Registration Dossier
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EC number: 953-082-3 | CAS number: -
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Erratum to Monograph ''Valencene''
- Author:
- Letizia, C.S., Cocchiara, J., Wellington, G.A., Funk, C. and Api, A.M.
- Year:
- 2 001
- Bibliographic source:
- [Food and Chemical Toxicology 38 Supplement 3 (2000) S235-S236]. Food and Chemical Toxicology, 7(39), p.757.
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Guideline:
- other: Maximization test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- [1R-(1α,7β,8α)]-1,2,3,5,6,7,8,8a-octahydro-1,8a-dimethyl-7-(1-methylvinyl)naphthalene
- EC Number:
- 225-047-6
- EC Name:
- [1R-(1α,7β,8α)]-1,2,3,5,6,7,8,8a-octahydro-1,8a-dimethyl-7-(1-methylvinyl)naphthalene
- Cas Number:
- 4630-07-3
- Molecular formula:
- C15H24
- IUPAC Name:
- 3-isopropenyl-4a,5-dimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalene
1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- 25 healthy male volunteers
- Route of administration:
- dermal
- Details on study design:
- Application of 5% valencene in petrolatum under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hr periods. Patch sites were pretreated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a 10- to 14-day rest period, challenge patches were applied under occlusion to fresh sites for 48-hours. Challenge applications were preceded by 30-minute applications of 5% aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side.
Results and discussion
- Results of examinations:
- No reactions were produced that were considered significantly irritant or allergic.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
