Registration Dossier

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: 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:
1974
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:
1973
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
Name:
Unnamed
Type:
Constituent

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.