Registration Dossier
Registration Dossier
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EC number: 208-008-8 | CAS number: 505-32-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed data, available as short summary from secondary source, reliability according to HPV/ICCA SIDS.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Report on human maximization studies. Report to RIFM, unpublished.
- Author:
- Epstein WL
- Year:
- 1 981
- Bibliographic source:
- RIFM-FEMA Database, Location 1792
- Reference Type:
- secondary source
- Title:
- Report on human maximization studies. Report to RIFM, unpublished.
- Author:
- Epstein WL
- Year:
- 1 981
- Bibliographic source:
- ICCA HPVC Programme IUCLID SIDS
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human maximization test, procedure modified after JID 47: 393-409, 1966.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- EC Number:
- 208-008-8
- EC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Cas Number:
- 505-32-8
- Molecular formula:
- C20H40O
- IUPAC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Details on test material:
- - Name of test material (as cited in study report): isophytol
- Physical state: not reported
- Analytical purity: not reported
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 27
- Sex: male and female - Controls:
- Additional challenge site with vehicle only.
- 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 further specified
- Vehicle / solvent: petrolatum
- Concentrations: 10 %
- Volume applied: not reported
- Testing/scoring schedule: 5x induction for 48-hour periods on alternate days and challenge for 48 hours after a 10- to 14-day treatment-free interval
- Removal of test substance: no
Results and discussion
Any other information on results incl. tables
In this study approximately one-third of the subjects were slightly irritated by the SLS pretreatment. No other significant reactions were seen.
The test substance produced no reactions that were considered either irritant or allergic in the 27 subjects tested.
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.
