Abstract
A series of studies designed to characterize a procedure for the in vivo assessment of drug-induced phototoxicity using the mouse ear is described. Among the characteristics of this procedure are (a) utilization of a wider spectrum of light exposure [including UVA, UVB, and visible light (daylight)] that more closely approximates natural sunlight, (b) determination and optimization of system variables such as intensity of light delivered and variability of light intensity with respect to distance from the source, (c) establishment of duration of light exposure necessary to elicit a phototoxic response, and (d) validation of the system utilizing a diverse group of known human phototoxicants (standards) against which the phototoxic potential of a test compound can be judged. Additionally, the data derived from this in vivo system have been found to correlate with clinical phototoxicity data. This procedure is recommended to be utilized in combination with both in vitro phototoxicity data and absorption spectrum data of a compound in order to evaluate more completely the preclinical phototoxic potential of the agent.
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