Examination of the Inclusion of UV Wavelengths 400nm to 700nm (Visible Light) in Photosafety Testing

Dr. Sabine Teske^a, Jeffrey Berg^a, Stacey Risk^a, Dr. Robert Sayre^b, Dr. John C. Dowdy^b
aHill Top Research, ^bRapid Precision Testing Laboratories

Poster presented at the SCC Florida Sunscreen Symposium, Orlando, FL, September, 2007 and also at the Society of Cosmetic Chemists' Annual Scientific Meeting & Technology Showcase. December, 2007.

ABSTRACT

Both the European Agency for the Evaluation of Medicinal Products (EMEA) and the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) provide guidance for photosafety testing. Both documents are intended to guide the industry in determining if a product should be tested for photoirritation and/or photoallergy and, if so, which test is most appropriate. Although in vitro methods are available and are an essential tool in determining preclinical and light absorption data, clinical testing is often more predictive of potential phototoxic effects in humans. Clinical tests most often assess photoirritation using the phototoxicity method and photosensitization using the photoallergy method. Typically, standard methods of UV exposure are conducted using a solar simulator which filters out the majority of visible light thus leaving only UVA and/or UVB. As indicated in both guidelines, absorption not only occurs in the UVA (320-400nm) and UVB (290-320nm) ranges, but may also occur in the visible light range (400-700nm). Therefore, it is important for the industry to understand the potential interaction of visible light with drug, household, and cosmetic products and the impact on human safety, the history of test methods using visible light, and how visible light can be incorporated in future photosafety testing in a clinical setting.

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