title: Standardized protocols for photocarcinogenesis safety testing.
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.
authors.affiliation: Argus Research, Charles River Laboratories, Inc. Horsham, PA 19044, USA. forbes@toxarus.com
authors.forename: P Donald
authors.initials: PD
authors.lastname: Forbes
authors.forename: Janusz Z
authors.initials: JZ
authors.lastname: Beer
authors.forename: Homer S
authors.initials: HS
authors.lastname: Black
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Cesarini
authors.forename: Curtis A
authors.initials: CA
authors.lastname: Cole
authors.forename: Ronald E
authors.initials: RE
authors.lastname: Davies
authors.forename: John M
authors.initials: JM
authors.lastname: Davitt
authors.forename: Frank
authors.initials: F
authors.lastname: deGruijl
authors.forename: John
authors.initials: J
authors.lastname: Epstein
authors.forename: Anny
authors.initials: A
authors.lastname: Fourtanier
authors.forename: Adèle
authors.initials: A
authors.lastname: Green
authors.forename: Thomas
authors.initials: T
authors.lastname: Koval
authors.forename: Ronald D
authors.initials: RD
authors.lastname: Ley
authors.forename: Romano
authors.initials: R
authors.lastname: Mascotto
authors.forename: Warwick
authors.initials: W
authors.lastname: Morison
authors.forename: Robert
authors.initials: R
authors.lastname: Osterberg
authors.forename: David
authors.initials: D
authors.lastname: Sliney
authors.forename: Frederick
authors.initials: F
authors.lastname: Urbach
authors.forename: Jan C
authors.initials: JC
authors.lastname: van der Leun
authors.forename: Antony R
authors.initials: AR
authors.lastname: Young
mesh_terms: D000818:Animals; D015197:Carcinogenicity Tests / Q000379:methods* / Q000592:standards*; D004354:Drug Screening Assays, Antitumor / Q000379:methods* / Q000592:standards*; D006801:Humans; D009381:Neoplasms, Radiation-Induced / Q000139:chemically induced*; D014466:Ultraviolet Rays