Irritation Test (14- or 21-day)
determine and rank the relative dermal irritancy of a series of test
healthy men and women
to 21-day test
Start test within 2 weeks of receipt of samples
Report issued within 3 weeks of study completion
oz. of each test material
assessment of skin response by a trained evaluator
Statistical analysis between the cumulative irritation scores
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.
responses are scored according to the following 6-point scale:
= (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.
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.
patches are worn until Monday. Monday's irritation scores are also
recorded as Sunday's scores, and Sunday is counted as an exposure