Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 906-125-5 | CAS number: -
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance contact dermatitis - a worldwide multicenter investigation (Part III)
- Author:
- Larsen W, Nakayama H, Fischer T, Elsner P, Frosch P, Burrows D, Jordan W, Shaw S, Wilkinson J, Marks Jr. J, Sugawara M, Nethercott M and Nethercott J
- Year:
- 2 002
- Bibliographic source:
- Contact Dermatitis, 46(3), 141-144
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- patch test
- GLP compliance:
- no
Test material
- Reference substance name:
- Nerol
- EC Number:
- 203-378-7
- EC Name:
- Nerol
- Cas Number:
- 106-25-2
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-(Z)-2,6-dien-1-ol
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 218
- Sex: 32 male, 186 female
- Age: 46.3 +/- 14.7 years,
- Demographic information: tested in 7 centers (Japan, Northern Ireland, United States, England, Germany, Switzerland and Sweden). - Clinical history:
- - History of allergy or casuistics for study subject or populations: fragrance sensitivity
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Vehicle / solvent:petrolatum
- Concentrations: 5%
- Testing/scoring schedule: initially at 2 - 3 days. The sites were re-examined in the majority of cases between 2 and 5 days after the 1st reading.
- Other: Patch test methods and readings were conducted according to internationally accepted criteria
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 13/218
- Number of subjects with negative reactions: 205/218
Applicant's summary and conclusion
- Conclusions:
- Nerol was sensitizing in 6% of subjects when applied at 5% in petrolatum
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.
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