Registration Dossier
Registration Dossier
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EC number: 214-730-4 | CAS number: 1191-16-8
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: Basic data given
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
- Reference Type:
- secondary source
- Title:
- Report to RIFM
- Author:
- Kligman AM
- Year:
- 1 977
- Bibliographic source:
- cited in Fragrance raw materials monograph - Prenyl acetate; Food Cosmet. Toxicol.1982; 20, 994
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human maximization test according to Kligman AM (1966); J. Invest. Dermatol. 47, 393 – 409
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-methyl-2-butenyl acetate
- EC Number:
- 214-730-4
- EC Name:
- 3-methyl-2-butenyl acetate
- Cas Number:
- 1191-16-8
- Molecular formula:
- C7H12O2
- IUPAC Name:
- 3-methylbut-2-en-1-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): Prenyl Acetate
- Lot/batch No.: RIFM #77-20-400
No addtitional details provided
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 25
- Sex: (12 males, 13 females)
- Age: 18-45 - Clinical history:
- Healthy (not further specified)
- Route of administration:
- dermal
- Details on study design:
- Pre-Test: The material was pre-tested on twenty-five subjects in order to determine whether sodium lauryl sulfate pre-treatment was required. A patch of the material was applied to normal sites an the volar forearms or backs for 48 hours under occlusion. No subject had any Irritation from this material and it was decided to use SLS pre-treatment in the test.
Main test: The test material is applied under occlusive dressings to the same site (forearm or scapular back) for five 48-hour periods. Prior to each exposure the site was pretreated with 2.5% aqueous sodium lauryl sulfate under occlusive dressings for a 24-hour period. Following a ten day rest period, a challenge patch of the test material is applied to a different site (scapular back) for a 48-hour period under occlusion. The challenge site is pre-treated for one hour with 5% to 10 % aqueous sodium lauryl sulfate under occlusion. Observations are made immediately after removal of the challenge patch and 24 hours thereafter.
- Concentrations: 20% in petrolatum
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/25
- Number of subjects with negative reactions: 25/25
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.
