Registration Dossier

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 Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

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:
Volunteers were exposed to 4% test substance in petrolatum. The test substance is applied under occlusive dressing to the same sites on the volar forearms for five 48-hour periods. Prior to the first exposure, the site was pre-treated with 2% aqueous SLS under occlusion for 24 hours. Following a 10-14 day rest period, a challenge patch of the test substance is applied to a different site for 48 hours under occlusion. Half of the challenge site is pre-treated for 0.5 hour with 2% aqueous SLS under occlusion. Observations are made immediately after removal of the challenge patch and 24 hours thereafter.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 35 (29 completed the study)
Route of administration:
dermal
Details on study design:
- Concentration: 4% in petrolatum
- Pre-test: A patch of the test material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and it was decided to use SLS pre-treatment in the test.
- Maximization test: Modified after to Maximization Test (J.I.D.; vol. 47; No. 5; 363-409; 1966). The test substance is applied under occlusive dressing to the same site on the volar aspects of the forearms of all subjects for five alternate day 48-hour periods. Prior to the first exposure, the site was pre-treated with 2% aqueous sodium lauryl sulfate under occlusive dressings for a 24-hour period. Following a 10-14 day rest period, a challenge patch of the test substance is applied to a different site for a 48-hour period under occlusion. Challenge applications were preceded by 30 minute applications of 2% SLS under occlusion on the left side of the back whereas the test substance was applied without SLS treatment on the left and petrolatum on the right and labeled site 5. Observations are made immediately after removal of the challenge patch and 24 hours thereafter.

Results and discussion

Results of examinations:
No effects were observed.

Applicant's summary and conclusion