Registration Dossier
Registration Dossier
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EC number: 202-676-4 | CAS number: 98-52-2
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:
- documentation insufficient for assessment
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Monographs on Fragrance Raw Materials: 4-tert-BUTYLCYCLOHEXANOL
- Author:
- Opdyke, D.L.J.
- Year:
- 1 974
- Bibliographic source:
- Food Cosmet Toxicol 12: 833
- Reference Type:
- other: Report to Research Institute for Fragrance Materials, Inc.
- Title:
- Report to RIFM, 9. May
- Author:
- Kligman, A.M.
- Year:
- 1 973
- Bibliographic source:
- as cited in Opdyke, 1974
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- A maximization test according to Kligman, 1966 (J. invest. Derm. 47: 393) was carried out with the test substance at a concentration of 4% in petrolatum on 25 human volunteers.
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
Test material
- Reference substance name:
- 4-tert-butylcyclohexanol
- EC Number:
- 202-676-4
- EC Name:
- 4-tert-butylcyclohexanol
- Cas Number:
- 98-52-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- 4-tert-butylcyclohexan-1-ol
Constituent 1
Method
- Type of population:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: maximization test (Kligman, 1966, The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers, J. invest. Derm. 47: 393)
ADMINISTRATION
- Vehicle / solvent: petrolatum
- Concentrations: 4%
Results and discussion
- Results of examinations:
- The substance was found not to be sensitising.
Applicant's summary and conclusion
- Conclusions:
- The substance was not sensitising in a maximization test carried out on 25 volunteers at a concentration of 4% in petrolatum.
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