Didodecyl 3,3'-thiodipropionate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only secondary source.

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Final Safety Assessment of Thiodipropionic Acid and Its Dialkyl Esters as Used in Cosmetics

Author:

Diamante C et al.

Year:

2011

Bibliographic source:

International Journal of Toxicology 29(Supplement 3) 137S-150S

Reference 2

Reference Type:

secondary source

Title:

Final Report on the Safety Assessment of Dilauryl Thiodipropionate

Author:

Liebert MA

Year:

1992

Bibliographic source:

Journal of the american college of toxicology

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:

A makeup foundation containing 0.05% of the test substance was tested for irritation and sensitization potential using a modified Draize-Shelanski-Jordan patch test on 224 volunteers of both genders and of mixed ethnicity (AfricanAmerican, Asian or Pacific Islander, Hispanic, or white).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Kaolin

Cas Number:

1332-58-7

IUPAC Name:

Kaolin

Details on test material:

- Name of test material (as cited in study report): Dilauryl thiodipropionate
- Analytical purity: 0.05%

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 224
- Sex: males and females
- Race: mixed ethnicity (AfricanAmerican, Asian or Pacific Islander, Hispanic, or white)

Clinical history:

Potential test subjects were excluded from the study if they had skin disease that could affect the interpretation of test results, if they were undergoing treatment for skin diseases other than dandruff or athlete’s foot, or if they were taking anti-inflammatory medication.

Route of administration:

dermal

Details on study design:

The test material, 0.2 mL, was applied to an occlusive patch and allowed to dry before being placed on the upper back of each subject. Patches remained in place for 24 hours, and upon removal, the patch test sites were evaluated and reactions were rated on a scale of 0 (no reaction) to 4 (intense erythema with edema and vesicles). A nontreatment period of 24 hours followed the initial patch application. The test sites were reevaluated before the application of the next patch. This procedure was followed every Monday, Wednesday, and Friday (there was a 48-hour nontreatment period over the weekends) for a total of 10 patch applications. A 13-day nontreatment period followed the tenth induction patch. At the end of this period, a 48-hour challenge patch was applied to the same site as the induction patches. Test sites were scored immediately upon patch removal. A second 48-hour challenge patch was applied 1 week later. This site was scored immediately upon patch removal and again at 72 hours.

Results and discussion

Results of examinations:

Thirteen of the test subjects did not complete the entire study. No signs of irritation were observed in any of these subjects at the time they left the study. Of the remaining 211 test subjects, 1 had a nonspecific irritation reaction during the induction phase of the study; this reaction had subsided prior to the next patch application and did not recur. No reactions were observed in any of the other test subjects. Under the conditions of the study, the makeup foundation containing 0.05% of the test substance was neither an irritant nor a sensitizer to human skin.