Tetrahydro-2-isobutyl-4-methyl-2H-pyran

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

MAXIMIZATION PR0CEDURE: (Modified after Kligman, JID, 47:393-409, 1966).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 23

Route of administration:

dermal

Details on study design:

- Vehicle / solvent: DEP
- Concentrations: 10%

The test material was applied under occlusion to the same site an the upper aspect of the arm of all subjects for 5 alternate day 48-hour periods. Patch sites were pretreated for 24 hours with 7.5% aqueous SLS under occlusion for the inital patch only. Following a 10-14 day rest period challenge patches of all materials were applied under occlusion to fresh sites for 48 hours.
Challenge applications were preceded by 30-minute application of 7.5% aqueous SLS under occlusion on the left side of the back or the left arm whereas the test material was applied without- SLS treatment an the right side. Also, a second site was tested with DEP alone.

Results and discussion

Results of examinations:

SLS pretreatment at the challenge patches produced irritation in nearly half of the subjects-, and there were some tape reactions, but no significant skin irritation or evidence of skin sensitization was observed with the test material in this study.