Esterification product of sunflower-oil fatty acids, with 1,4:3,6-dianhydro-D-glucitol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 6 January 2016 to 12 February 2016

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:

2016

Report date:

2016

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: The method is modified to test 50 panelist and not 200 required in Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, published by the Association of Food and Drug Officials. The method also employs nine inducting patching and not ten

Deviations:

not applicable

Principles of method if other than guideline:

0.2 ML of the diluted test item (10% in corn oil) was dispensed onto the occlusive, hypoallergenic patch. The patch was applied directly to the skin of the infracapsular regions of the back to the right or left of the midline and the subject was dismissed with instructions not to wet or expose this area to direct sunlight. After 24 hours the patch was removed by the panelist at home. This procedure was repeated until a series of nine consecutive 24 hours exposures have been made for every Monday, Wednesday and Friday for three consecutive weeks. In the event of adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine. Subject were then given 10-14 day rest period after which a challenge or retest dose was applied once to a previously unexposed site. The retest dose is equivalent to any one of the original nine exposures. Reactions are scored 24 and 48 hours after application. Comparison was made between the nine inductive responses and the retest dose.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

1818326-42-9

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the sponsor, Lot #CB 15026
- Expiration date of the lot/batch: not detailed
- Purity test date: not detailed

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not detailed
- Stability under test conditions: not detailed
- Solubility and stability of the test substance in the solvent/vehicle: not detailed
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: diluted in corn oil
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel:10 % in corn oil

FORM AS APPLIED IN THE TEST (if different from that of starting material)
diluted in corn oil and applied in the patch

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 54
- Sex: Male and Female
- Age: 18-70
- Race: Caucasian ; Hispanic ; Asian ; African American
- Demographic information: not detailed

Clinical history:

- History of allergy or casuistics for study subject or populations: Individuals with chronic allergies were excluded
- Symptoms, onset and progress of the disease: Individuals who were under doctor's care were excluded
- Exposure history: Individuals with a history of an acute or chronic disease that may have interfered with or increased the risk of study participation were excluded
- Aggravating factors both in home and workplace: not specified
- Family history: not specified
- Medical history (for respiratory hypersensitivity): Individuals who were currently taking any medication (topical or systemic) that may have masked or interfered with the test results were exluded from the study
- Any other allergic or airway disorders: Individuals with chronic allergies were excluded
- Smoking history: not specified

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 ; Parke-Davis Hypoallergenic Readi Bandages (20x20cm Webril affixed to the center of a 40x40 mm adhesive bandage) or the equivalent
- Vehicle / solvent: corn oil
- Concentrations: 10%
- Volume applied: 0.2 mL
- Testing/scoring schedule: At the moment of the application of the second patch through the nine, and the next date following application none
- Removal of test substance: after 24 hours

EXAMINATIONS
- Grading/Scoring system: Not detailed
- Statistical analysis: Not detailed

Results and discussion

Results of examinations:

No adverse reactions of any kind were noted during the course of this study

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions of the study, the test item HydraSynol was considered as a Non-Primary Irritant and a Non-Primary Sensitizer.

Executive summary:

This non-GLP compliant study was perform in order to investigate a potential irritation property or sensitizing property of the HydraSynol IDL on human based on an Human Repeated Insult Patch Test method (HRIPT).

54 subjects were used in this study. 0.2 ML of the diluted test item (10% in corn oil)  was dispensed onto the occlusive, hypoallergenic patch. The patch was applied directly to the skin of the infracapsular regions of the back to the right or left of the midline and the subject was dismissed with instructions not to wet or expose this area to direct sunlight. After 24 hours the patch was removed by the panelist at home. This procedure was repeated until a series of nine consecutive 24 hours exposures have been made for every Monday, Wednesday and Friday for three consecutive weeks. In the event of adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine. Subject were then given 10-14 day rest period after which a challenge or retest dose was applied once to a previously unexposed site. The retest dose is equivalent to any one of the original nine exposures. Reactions are scored 24 and 48 hours after application. Comparison was made between the nine inductive responses and the retest dose.

No adverse reactions of any kind were noted during the course of this study

Under the experimental conditions of the study, the test item HydraSynol was considered as a Non-Primary Irritant and a Non-Primary Sensitizer.