Speaker Abstract: S-37
Animal Studies for Assessing the Safety of Sunscreens, Cosmetics and Drugs
Paul C. Howard, National Center for Toxicological Research/FDA
The FDA has had an ongoing interest in the phototoxicity and photocarcinogenicity of therapeutics, cosmetics, devices, food supplements and food additives. The National Toxicology Program (NTP) reviews nominations and funds studies testing the toxicity and carcinogenicity of chemicals, and occassionally, receives nominations that require phototoxicity or photocarcinogenicity testing. The FDA and NTP have addressed their research and testing needs by developing the NTP Center for Phototoxicology at NCTR. This facility is charged with conducting mechanistic and photocarcinogenesis studies on compounds of mutual interest to the FDA and NTP. Chemicals are nominated through the FDA and NTP chemical nomination processes. The studies are designed to meet GLP requirements and provide information suitable for understanding the human health risk of the test compound. Depending on the specific study design, studies are conducted with simulated solar light or fluorescent lamp generated light. The SKH-1 hairless mouse is the current test animal, and studies on the suitability of transgenic mice are under consideration. Chemicals that are currently under study include topically applied alpha- and beta-hydroxy acids, aloe vera, and retinyl palmitate. Mechanistic studies are in progress on the photodecomposition, phototoxicity and photocarcinogenesis of tattoo ink pigments, and transport of nanoscale quantum dots through mouse skin. The uniqueness of the Center for Phototoxicology is that mechanistic studies are conducted concurrently with photocarcinogenesis studies in an effort to understand the mechanism of action of chemicals. In addition, the Cener for Phototoxicology is being used to address basic science questions concerning the impact of light on biological systems. The research conducted in this facility is designed to support the public health missions of the FDA and NTP.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-MAY-28 by frf