IMR Press / FBL / Volume 8 / Issue 4 / DOI: 10.2741/975

Frontiers in Bioscience-Landmark (FBL) is published by IMR Press from Volume 26 Issue 5 (2021). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement with Frontiers in Bioscience.

Open Access Article
Standardized protocols for photocarcinogenesis safety testing
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1 Argus Research, Charles River Laboratories, Inc. Horsham, PA 19044, USA
2 US Food and Drug Administration, Center for Devices and Radiologic Health, Rockville, MD, 20852, USA
3 Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas 77030, USA
4 Foundation Rothchild, 75019 Paris, France
5 Johnson & Johnson Consumer Products Co., Skillman, NJ 08558, USA
6 Chisholm Township, Ontario POH 1ZO, Canada
7 Regulatory Affairs Services, Silver Spring, MD 20904, USA
8 Dermatology, Leiden University Medical Center, Leiden, Netherlands
9 450 Sutter St., Suite 1306, San Francisco, CA 94108, USA
10 Groupe Dermato-Biologie, L'Oreal, 92583 Clichy Cedex, Paris, France
11 Queensland Institute Medical Centre, Brisbane, Queensland 4029, Australia
12 NCRP, Suite 800, Bethesda, MD 20814 USA
13 University of New Mexico, Albequerque, NM 87131-5218, USA
14 Corporate Research and Development, L'Oreal, 92583 Clichy Cedex, Paris, France
15 10753 Falls Rd., Suite 205, Lutherville, MD 21093, USA
16 U.S. Food and Drug Administration, Rockville, MD 20857, USA
17 U.S. Army Environmental Hygiene Agency, Aberdeen Proving Grounds, MD 21010-5422, USA
18 438 Clairemont Road, Villanova, PA 19085-1706 USA
19 EcoSys, Utrecht, Netherlands
20 St. John's Institute of Dermatology, King's College, London, SE1 7EH, United Kingdom

Academic Editor: Homer Black

Front. Biosci. (Landmark Ed) 2003, 8(4), 848–854; https://doi.org/10.2741/975
Published: 1 May 2003
(This article belongs to the Special Issue Photocarcinogenesis)
Abstract

Solar ultraviolet radiation (UVR) is recognized as a major cause of non-melanoma skin cancer in man. Skin cancer occurs most frequently in the most heavily exposed areas and correlates with degree of outdoor exposure. The incidence of skin cancer is also increased by contact with photosensitizing drugs and chemicals such as psoralens, coal tars and petroleum stocks. Other substances which do not act as photosensitizers, such as immunosuppressants taken by organ transplant recipients, also increase the risk of skin cancer. The U.S. Food and Drug Administration requests, on a case-by-case basis, that risk of enhanced photocarcinogenesis is assessed for many classes of drugs. Health Canada's Therapeutic Products Programme has issued a Notice of Intent to regulate pharmaceutical products which may enhance carcinogenicity of the skin induced by ultraviolet radiation. Other national regulatory agencies review such data when they exist, but their own requirements emphasize batteries of short-term in vitro and in vivo tests. While they may support drug development strategies, short-term tests have yet to be validated as predictors of the ability of drugs or chemicals to enhance photocarcinogenesis. Published protocols now describe study designs and procedures capable of determining whether test agents enhance the rate of formation of UVR-induced skin tumors.

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