Registration Dossier

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

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.

Applicant's summary and conclusion