Cumulative Irritation
Outline: Cumulative Irritation Test (14- or 21-day)
Objective: To determine and rank the relative dermal irritancy of a series of test articles.
Subjects:

20-25 healthy men and women

Timing:

14 to 21-day test
Start test within 2 weeks of receipt of samples
Report issued within 3 weeks of study completion

Quantity: 8 oz. of each test material

Methodology:
Clinical assessment of skin response by a trained evaluator
Statistical analysis between the cumulative irritation scores

Procedures:
Approximately 0.2 mL or grams of each test article is applied occlusively to each subject's back daily, Monday through Saturday.* The patches are removed at the ETC Clinic and the sites scored just prior to the next patch application. This procedure is repeated for 14 or 21 days, or until irritation scores of "3" or "4" are observed. If this occurs, application of the test article is discontinued and the score attained is entered for the balance of the 14 or 21 observations.

At the Sponsor's option and for an additional fee, a Challenge phase may be added after a 2-week Rest phase to assess the sensitization potential of the test articles.

Skin responses are scored according to the following 6-point scale:
0 = (None) No evidence of any effect.
+ = (Barely perceptible) Minimal, faint uniform or spotty erythema.
1 = (Mild) Pink, uniform erythema covering most of the contact site.
2 = (Moderate) Pink-red erythema, uniform in the entire contact site.
3 = (Marked) Bright red erythema with/without petechiae or papules.
4 = (Severe) Deep red erythema with/without vesiculation or weeping.

Accompanying edema (swelling) at any test site is recorded with an "e" and described as mild, moderate or severe. Other possible dermal sequelae are similarly recorded.

*Saturday's patches are worn until Monday. Monday's irritation scores are also recorded as Sunday's scores, and Sunday is counted as an exposure day.