Registration Dossier
Registration Dossier
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EC number: 235-970-6 | CAS number: 13074-65-2
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: Limited reporting of all aspects of study and ethical concerns regarding use of prison inmates.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- other: study with inmates
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was applied under occlusion to same site on the interior of the forearm, for five, alternate-day 48-hr periods. The site was pre-treated for 24 hrs with 5% sodium lauryl sulphate before the initial application. After a 10-14 day rest period, patches were applied to previously untreated sites, for 48 hrs, under occlusion.
- GLP compliance:
- no
Test material
- Reference substance name:
- hexyl cyclopentanone
- IUPAC Name:
- hexyl cyclopentanone
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): hexyl cyclopentanone
- Substance type: no data.
- Physical state: no data.
- Analytical purity: no data.
- Impurities (identity and concentrations): no data.
- Composition of test material, percentage of components: no data.
- Isomers composition: no data.
- Purity test date: no data.
- Lot/batch No.: 80-10-75.
- Expiration date of the lot/batch: no data.
- Stability under test conditions: no data.
- Storage condition of test material: no data.
Constituent 1
Method
- Type of population:
- other: prison inmate
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 27
- Sex: male
- Age: 21-45
- Race: white (11/27), black (9/27), Mexican (5/27), oriental (1/27), Asian (1/27) - Controls:
- no data.
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- No sensitisation reactions reported.
Applicant's summary and conclusion
- Conclusions:
- Jasmatone (hexyl cyclopentanone) was found to be not sensitising in a maximisation test in human subjects.
- Executive summary:
In an in vivo maximisation test, conducted in human subjects (prison inmates), Jasmatone (hexyl cyclopentanone) was found to be non sensitising. There were no reactions that were considered to represent skin sensitisation in the 27 subjects tested.
Only limited study details are available and such a test would not gain ethical approval in most countries if conducted today.
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