Fatty acids, C14-18, C14-18-alkyl esters

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scienific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

The test substance was applied to the skin of 52 healthy human volunteers of both sexes under occlusive patches. For induction, the test substance was applied three times per week, Monday, Wednesday, and Friday, for a total of ten applications. The patches remained on the skin for 24 h. This was then followed by a rest period of 24 h following the Tuesday and Thursday removal, and 48 h following the Saturday removal. At the conclusion of the 14 day rest period following the tenth application, challenge patches were applied to the original sites and to virgin sites. Macroscopic examination of the application sites were then conducted about 24 and 48 hours after challenge patch removal.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

85566-24-1 (20% in formulation)

IUPAC Name:

85566-24-1 (20% in formulation)

Details on test material:

- Name of test material (as cited in study report): [only trade name given]
- Analytical purity: no data

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 52
- Sex: 42 Females and 8 Males
- Age: 18 -65 years
- Other: 51 individuals completed the study

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: 1.5" x 2" gauze portion of a coverlet adhesive dressing
- Concentrations: 20% in formulation
- Volume applied: 0.15 mL
- Testing/scoring schedule: the test substance was applied to the upper back (between the scapulae) of volunteers, 3 days a week for a total of 10 induction exposures. After a rest period of 14 days, one challenge was performed and the skin assessed for sensitisation reactions.

Results and discussion

Results of examinations:

No sensitisation reactions were observed