In these studies, Product A is more irritating than Product B when assessed objectively, i.e., by scoring irritation at the test sites, and subjectively, i.e., by evaluating reports of adverse sensations perceived by panelists. There is no clear relationship between specific test conditions, i.e., compromised skin and/or testing wet samples, and reports of perceived sensory reactions. However, some sensory reactions appear to be associated with higher levels of irritation. The most cost-effective protocol to use for screening for potential irritant effects for catemenial pads, baby and adult diapers is two 6-h sample applications on intact skin, with scoring in the afternoon 30 min after removal of the sample. For claims support testing, a variety of test conditions can be used in the behind-the-knee assay to mimic the exposure conditions for the product under evaluation, including using compromised (tape stripped) skin and wet product samples.

All four protocol variations of the standard upper arm patch test can be used to assess the inherent chemical irritant properties of feminine protection products. For these products, which are inherently non-irritating, tape stripping and/or applying wet samples does not increase the sensitivity of the patch test method. Differences in irritation potential were apparent after one to three 24-h applications. Therefore, the standard patch test protocol can be shortened to three applications without compromising our ability to detect differences in the chemical irritation produced by the test materials. The patch test can be used to evaluate effectively the inherent chemical irritation potential of these types of products. However, this method is not suitable for testing the mechanical irritation due to friction that occurs during product use. There is no relationship between specific test conditions, i.e., compromised skin and/or testing wet samples and reports of perceived sensory reactions. However, there seems to be a clear relationship between sensory reactions and objective irritation scores.

No abstract

Based upon microbial assessments, colposcopic examinations, adverse events, and subject reporting of comfort, the ultra absorbency tampon is similar in safety profile to the currently marketed super plus absorbency tampon.