Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-06-30 to 2004-08-12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study report which meets basic scientific principles, guideline study, no GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: ICH Guideline E6

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids

EC Number:

947-474-3

Molecular formula:

not available

IUPAC Name:

Reaction products resulting from esterification of sucrose with saturated C16-18 (even numbered) fatty acids

Test material form:

solid: pellets

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 112 (male and females) were selected. 104 subjects remained in the study and completed it.
- Sex: Male and female
- Age: From 16 to 78 years.

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: Repeated Insult Patch test

ADMINISTRATION
- Type of application: occlusive
- Treatment area: Upper back between the scapulae served as the treatment area.
- Description of patch: 0.2 mL of test material, or an amount sufficient to cover the contact surface, was applied to the 3/4" x 3/4" absorbent pad portion of an adhesive dressing.
- Vehicle: Cetiol CC
- Removal of test substance: Participants were instructed to remove all induction patches at home, 24 hours after application.
- Concentrations: The test material was prepared as a 50 % dilution, using the supplied diluent, Cetiol CC.
- Induction phase: Patches were applied 3 times per week for a total of nine applications.
- Challenge phase: Approximately two weeks after final Induction patch application, a Challenge patch was applied to a virgin test site adjacent to the original Induction patch site.


EXAMINATIONS
- Grading/Scoring system: 0 = No visible skin reaction
+ = Barely perceptible or spotty erythema
1 = Mild erythema covering most of the test site
2 = Moderate erythema, possible presence of mild edema
3 = Marked erythema, possible edema
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 103
- Number of subjects with equivocal reactions: 1
- Number of subjects with irritating reactions: 1

Conclusion
With one exception, observation remained negative. Under the conditions of this study, the test material did not indicate a clinically significant potential for dermal irritation or induced allergic contact sensitization.