Cumulative Irritation (RIPT)

BioScience Laboratories Skin Technology Center performs the Human Repeat Insult Patch Test (RIPT) for cumulative skin irritation in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and Senstization Testing of Generic Transdermal Drug Products, December 1999.

The method requires that the product and its vehicle (product without active principle) be tested, along with a high-irritancy control material (generally, sodium lauryl sulfate, or SLS; also known as sodium dodecyl sulfate, or SDS), and a low-irritancy control material (e.g., 0.9% saline), by applying small quantities of the materials to single sites on the skin of the upper back of 30 or more subjects each day for 21 days and occlusively patching each site while the material is wet.  The degree of irritation at the sites is scored by a trained evaluator (BioScience Laboratories personnel and/or a licensed dermatologist) for degree of erythema/vesiculation/peripheral extension each day prior to reapplication of the materials. 

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