Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
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

Study type:
other: study on human subjects
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
The test substance was applied at a concentration of 4% in petrolatum to human subjects using an 48 h closed patch test.
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Subjects:
no data
Route of exposure:
dermal
Reason of exposure:
intentional
Details on exposure:
TYPE OF TEST(S) USED: 48 h closed patch test

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: petrolatum
- Concentrations: 4%

Results and discussion

Clinical signs:
No irritation was noted after a 48 h closed patch test with 4% test substance in petrolatum on human subjects.

Applicant's summary and conclusion

Conclusions:
No irritation was noted after a 48 h closed patch test with 4% test substance in petrolatum on human subjects.