{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T10:30:15Z","timestamp":1784975415628,"version":"3.55.0"},"reference-count":19,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2014,11,28]],"date-time":"2014-11-28T00:00:00Z","timestamp":1417132800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Int J Toxicol"],"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:p>Phototoxicity has a strong impact on drug development. Although several animal models have been developed to quantitatively assess human risks, none have been validated for standardized use. In this study, we validated an in vivo phototoxicity model using Long-Evans (LE) rats treated with 4 well-known phototoxic drugs, namely 8-methoxypsoralen, lomefloxacin, sparfloxacin, and pirfenidone. Daily macroscopic observations of skin and eyes, ophthalmological examinations 4 days after dosing, and blood sampling for toxicokinetics (TKs) were performed after exposure of treated animals to ultraviolet, and dose-dependent eye and\/or skin reactions were noted for all compounds. Margins of safety were calculated when possible and correlated well with known relative phototoxicity of the 4 compounds. We conclude that the present in vivo phototoxicity assay using LE rats with TK analysis can be used to quantitatively predict the risk of pharmaceutical phototoxicity in humans.<\/jats:p>","DOI":"10.1177\/1091581814559397","type":"journal-article","created":{"date-parts":[[2014,11,28]],"date-time":"2014-11-28T22:51:48Z","timestamp":1417215108000},"page":"16-23","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":22,"title":["Assessment of 8-Methosypsoralen, Lomefloxacin, Sparfloxacin, and Pirfenidone phototoxicity in Long-Evans Rats"],"prefix":"10.1177","volume":"34","author":[{"given":"Tamiko","family":"Adachi","sequence":"first","affiliation":[{"name":"Research Division, Safety Research Laboratories, Mitsubishi Tanabe Pharma Corporation, Kisarazu, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Satou","sequence":"additional","affiliation":[{"name":"Research Division, Safety Research Laboratories, Mitsubishi Tanabe Pharma Corporation, Kisarazu, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroko","family":"Satou","sequence":"additional","affiliation":[{"name":"Research Division, Safety Research Laboratories, Mitsubishi Tanabe Pharma Corporation, Kisarazu, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Shibata","sequence":"additional","affiliation":[{"name":"Research Division, Safety Research Laboratories, Mitsubishi Tanabe Pharma Corporation, Kisarazu, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoko","family":"Miwa","sequence":"additional","affiliation":[{"name":"Research Division, Safety Research Laboratories, Mitsubishi Tanabe Pharma Corporation, Kisarazu, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumiko","family":"Iwase","sequence":"additional","affiliation":[{"name":"Research Division, Safety 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Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2014,11,28]]},"reference":[{"key":"bibr1-1091581814559397","volume-title":"Guidance for Industry Photosafety Testing","author":"Center for Drug Evaluation and Research Food and Drug Administration","year":"2003"},{"key":"bibr2-1091581814559397","volume-title":"Note for Guidance on Photosafety Testing","author":"The European Agency for the Evaluation of Medicinal Product","year":"2002"},{"key":"bibr3-1091581814559397","volume-title":"Guidance on Photosafety Evaluation of Pharmaceuticals","author":"ICH Harmonised Tripartite Guideline","year":"2013"},{"key":"bibr4-1091581814559397","volume-title":"OECD Guidelines for the Testing of Chemicals, Test No. 432: In Vitro 3T3 NRU Phototoxicity Test","author":"Organization for Economic Cooperation and 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