Registration Dossier
Registration Dossier
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EC number: 230-291-1 | CAS number: 7011-83-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- The 2 % test substance was applied under occlusion to forearm or back of volunteers for 5 alternate-day 48 h periods. The patch sides were treated with sodium lauryl sulfate. The challenge was read after patch removal and after 24 h.
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-hexyldihydro-5-methylfuran-2(3H)-one
- EC Number:
- 230-291-1
- EC Name:
- 5-hexyldihydro-5-methylfuran-2(3H)-one
- Cas Number:
- 7011-83-8
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 5-hexyldihydro-5-methylfuran-2(3H)-one
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- Sex: female: 14, male: 11
- Age:18-52
- Race: 6 black, 19 white - Clinical history:
- No clinical history provided.
- Controls:
- No data provided.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Concentrations: 2 %
- Description of patch: on volar foremar or back
- Testing/scoring schedule: for 5 alternate-day 48 h periods, challenge was read after patch removal and after 24 h
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms observed
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 20
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- No skin sensitisation was observed.
- Executive summary:
A maximization test in 25 human volunteers was conducted. The 2 % test substance was applied on the volar forearm or back with an occlusive dressing for 5 alternate-day 48 h periods. The patch sides were pretreated with 2.5 % aqueous sodium lauryl sulfate under occlusion. The challenge side was read immediatly after patch removal and after 24 h. No volunteer showed any reaction on the skin. The test substance was not contact sensitising in humans.
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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