{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T10:39:36Z","timestamp":1777718376029,"version":"3.51.4"},"reference-count":23,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2016,7,10]],"date-time":"2016-07-10T00:00:00Z","timestamp":1468108800000},"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":[[2016,9]]},"abstract":"<jats:p>Tavaborole is a topical antifungal agent approved by the US Food and Drug Administration for the treatment of toenail onychomycosis. As part of the nonclinical development program, reproductive and developmental toxicity studies were conducted (rat oral fertility and early embryonic development, rat (oral) and rabbit (dermal) embryo\u2013fetal development). There were no effects on fertility or reproductive performance at doses up to 300 mg\/kg\/d (107 times the maximum recommended human dose [MRHD] based on mean area under the plasma concentration\u2013time curve comparisons). In the rat embryo\u2013fetal development toxicity studies, teratogenicity was not observed at doses up to 100 mg\/kg\/d (29 times the MRHD). However, several treatment-related skeletal malformations and variations were observed at 300 mg\/kg\/d (570 times the MRHD). In rabbit embryo\u2013fetal development toxicity studies dosed via oral or dermal administration, the no observable adverse effect level for maternal toxicity and embryo\u2013fetal toxicity was 50 mg\/kg\/d (16 times the MRHD) and 5% (26 times the MRHD), respectively.<\/jats:p>","DOI":"10.1177\/1091581816639113","type":"journal-article","created":{"date-parts":[[2016,4,4]],"date-time":"2016-04-04T21:10:02Z","timestamp":1459804202000},"page":"530-542","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":6,"title":["Tavaborole, a Novel Boron-Containing Small Molecule Pharmaceutical Agent for Topical Treatment of Onychomycosis"],"prefix":"10.1177","volume":"35","author":[{"given":"Vic","family":"Ciaravino","sequence":"first","affiliation":[{"name":"Anacor Pharmaceuticals, Inc, Palo Alto, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dina","family":"Coronado","sequence":"additional","affiliation":[{"name":"Anacor Pharmaceuticals, Inc, Palo Alto, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheryl","family":"Lanphear","sequence":"additional","affiliation":[{"name":"MPI Research, Mattawan, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan","family":"Hoberman","sequence":"additional","affiliation":[{"name":"Charles River Laboratories, Horsham, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjay","family":"Chanda","sequence":"additional","affiliation":[{"name":"Anacor Pharmaceuticals, Inc, Palo Alto, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2016,7,10]]},"reference":[{"key":"bibr1-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1159\/000017990"},{"key":"bibr2-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1517\/13543784.16.2.157"},{"key":"bibr3-1091581816639113","doi-asserted-by":"publisher","DOI":"10.7547\/87507315-87-12-571"},{"key":"bibr4-1091581816639113","doi-asserted-by":"publisher","DOI":"10.7547\/87507315-87-12-565"},{"key":"bibr5-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1016\/S0190-9622(98)70484-0"},{"key":"bibr6-1091581816639113","unstructured":"Lamisil (terbinafine hydrochloride) tablets [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2013."},{"key":"bibr7-1091581816639113","unstructured":"Sporanox (itraconazole) capsules [package insert]. Titusville, NJ: Janssen Pharmaceuticals; 2012."},{"key":"bibr8-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1021\/jm0603724"},{"key":"bibr9-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1126\/science.1142189"},{"key":"bibr10-1091581816639113","unstructured":"Kerydin\n                      \u00ae\n                      (tavaborole) topical solution, 5% [package insert]. Palo Alto, CA: Anacor Pharmaceuticals, Inc; 2014."},{"key":"bibr11-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1177\/1091581814545245"},{"key":"bibr12-1091581816639113","author":"Ciaravino V","journal-title":"Int J Toxicol"},{"key":"bibr13-1091581816639113","unstructured":"ICH Harmonised Tripartite Guideline. Detection of toxicity to reproduction for medicinal products & toxicity to male fertility. S5(R2), Current Step 4 version, Parent Guideline. 1993; Addendum dated November 9, 2000; incorporated in November 2005."},{"key":"bibr14-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1007\/BF00245415"},{"key":"bibr15-1091581816639113","doi-asserted-by":"publisher","DOI":"10.3109\/9781841848211"},{"key":"bibr16-1091581816639113","unstructured":"Derelanko MJ, Hollinger MA, eds. CRC Handbook of Toxicology. Boca Raton, FL: CRC Press; 1995:647."},{"key":"bibr17-1091581816639113","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1016\/S0022-3565(25)08751-8","volume":"82","author":"Draize JH","year":"1944","journal-title":"J Pharmacol Exp Ther"},{"key":"bibr18-1091581816639113","first-page":"370","volume-title":"Biometry: The Principles and Practice of Statistics in Biological Research","author":"Sokal RR","year":"1969"},{"key":"bibr19-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1955.10501294"},{"key":"bibr20-1091581816639113","first-page":"388","volume-title":"Biometry: The Principles and Practice of Statistics in Biological Research","author":"Sokal RR","year":"1969"},{"key":"bibr21-1091581816639113","first-page":"258","volume-title":"Statistical Methods","author":"Snedecor GW","year":"1967","edition":"6"},{"key":"bibr22-1091581816639113","doi-asserted-by":"publisher","DOI":"10.1080\/00401706.1964.10490181"},{"key":"bibr23-1091581816639113","first-page":"96","volume-title":"Nonparametric Statistics for the Behavioral Sciences","author":"Siegel S","year":"1956"}],"container-title":["International Journal of Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1091581816639113","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1091581816639113","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1091581816639113","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T10:24:59Z","timestamp":1777458299000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1091581816639113"}},"subtitle":["I. 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