the test results are certainly relevant to marketed formulations within the distinct product classes.
Therefore, this test method will provide an approach for assessing the acute irritation potential of new formulations relative to these benchmarks and within the product categories that are the subject of the current study. As noted above, specific formulation information for each generic test product is available on request from the SDA to facilitate such benchmark testing by others. The exposure conditions of this test (undiluted product under occlusive patch) deffer dramatically from any exposure conditions of typical product use. Hence, the clinical relevance of these results relates to their assess- ment of comparative irritation potential, not to any direct extrapolation to clinical irritation risk under any type of usage conditions. Using comparative results like this dataset, it may ultimately be possible to distinguish products into different categories of irritation potential, and perhaps use such data to make consumer-useful irritation labeling decisions. As a human test method, the irritation data obtained are valid by definition. However, more formulation testing will be needed, as well as inter-laboratory reproducibility testing, in order to assess the full utility of this method for product classification and labeling purposes.