Registration Dossier
Registration Dossier
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EC number: 222-376-7 | CAS number: 3452-97-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guideline studies
Data source
Referenceopen allclose all
- Reference Type:
- other: short report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The test substance was applied to the skin for 48 hours under an occlusive dressing
- GLP compliance:
- not specified
- Type of study:
- other: maximization study
- Justification for non-LLNA method:
- The study was performed before the LLNA method was established.
Test material
- Reference substance name:
- 3,5,5-trimethylhexan-1-ol
- EC Number:
- 222-376-7
- EC Name:
- 3,5,5-trimethylhexan-1-ol
- Cas Number:
- 3452-97-9
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,5,5-trimethylhexan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: 24 white and 1 black American citizens
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 25 healthy male and female volunteers attended
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% in petrolatum
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% in petrolatum
- No. of animals per dose:
- 25
- Details on study design:
- RANGE FINDING TESTS:
In pre-testing the test material was not irritating to the skin in any of the 25 subjects. A patch of the test material was applied to normal sites of the forearms or backs for 48 hours under occlusion.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 48 hours
- Test groups: 25 male and female volunteers
- Control group: none
- Site: volar forearms or backs
- Frequency of applications: alternate day
- Duration: 48 hours
- Concentrations: 8% in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2
- Exposure period: 48 hours; under occlusion
- Test groups: 25 male and female volunteers
- Control group: none
- Site: other site than during challenge
- Concentrations: 8% in petrolatum
- Evaluation (hr after challenge): immediately after removal of teh challenge patch and 24 hours thereafter
OTHER: rest period between induction and challenge: 10 days - Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- no sensitisation reactions noted in any of the subjects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 8% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: no sensitisation reactions noted in any of the subjects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- no sensitisation reactions noted in any of the subjects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 8% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: no sensitisation reactions noted in any of the subjects.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
3,5,5- trimethylhexanol was tested in a maximisation study for its skin sensitising potential in 25 healthy volunteers. The test substance (8% in petrolatum) was applied to the skin for 48 hours under an occlusive dressing. No sensitisation reactions were noted (Belsito et al. 2010; p. S33 and Table 10 on p. S41). A synopsis of the study is available (Kligman1977).
The study is considered to be reliable and suitable for assessment of this endpoint.
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