(4S)-1-methyl-4-(6-methylhepta-1,5-dien-2-yl)cyclohexene

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Reference 2

Reference Type:

other: secondary source from database

Title:

Report on human maximization studies. Report to RIFM.

Author:

W.L. Epstein

Year:

1974

Bibliographic source:

RIFM Fragrance and Flavor Database; Reference No 1801

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Human maximization test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-6-(4-methylcyclohex-3-en-1-ylidene)hept-2-ene

EC Number:

207-805-8

EC Name:

2-methyl-6-(4-methylcyclohex-3-en-1-ylidene)hept-2-ene

Cas Number:

495-62-5

Molecular formula:

C15H24

IUPAC Name:

4-(1,5-dimethylhex-4-en-1-ylidene)-1-methylcyclohexene

Details on test material:

Test substance name: Bisabolene
no further details provided

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 21
- Sex: male

Controls:

SLS controls; petrolatum controls

Route of administration:

dermal

Details on study design:

Pretest:
Test material was tested on all subjects to determine, if sodium lauryl sulfate (SLS) pretreatment is required.
A patch with the test substance was applied to normal sites on the back for 48 hours under occlusion. No significant irritation was observed from the test substance in any subject. Thus, SLS pretreatment was included into the main test.

Main Test:
The test substance was applied under occlusion to the same sites on the volar aspects of the forearms of all subjects for 5 alternate day 48 hours periods. Patch sites were pretreated for 24 hours with 5% aqueous SLS under occlusion for the initial patch only.
Following a 10-14 day rest period, challenge patches of the test substance was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceeded by 30 min applications of 2% aqueous SLS under occlusion on the left side of the back whereas the test item was applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right site.

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: Petrolatum
- Concentrations: 10%

Results and discussion

Results of examinations:

Skin reactions challenge (48h / 72h) no SLS pretreatment
Bisabolene: 0/0 of 21
Petrolatum: 0/0 of 21

Very little evidence of irritation was produced after the SLS pretreated challenge patch application (1 subject with a +/- reaction only) and no skin reactions were observed after removal of the challenge patch (and 24h later) without SLS pretreatment in any of the volunteers tested.