{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T17:01:59Z","timestamp":1777914119462,"version":"3.51.4"},"reference-count":36,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T00:00:00Z","timestamp":1620086400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Toxicol Pathol"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:p>The tolerability of single daily gavage doses of 0.5% or 2.0% (wt\/vol) sodium lauryl sulfate (SLS) in 11- to 12-week-old male CD-1 mice was evaluated in a study of 3 months in duration. Live-phase, gross necropsy, and histopathologic parameters were evaluated. Mortality of 14% occurred in mice administered formulations containing SLS. Clinical observations in mice administered SLS included abnormal respiration (audible, irregular, and\/or labored), swollen abdomen, rough haircoat, hunched appearance, and hypoactivity. Necropsy findings in mice administered SLS consisted of enlarged intestines containing abnormal contents with gas. There were no instances of mechanical gavage\u2013related injury. Histologic evaluation of the respiratory tract revealed injury to the nasal passages and nasopharynx, including, but not limited to, inflammation, exudate, apoptosis\/necrosis of epithelium, and atrophy of epithelium or olfactory nerves. Collectively, the data indicated that under the experimental conditions of our 3-month study in male CD-1 mice, once-daily gavage administration of vehicle formulations containing SLS at 0.5% or 2.0% resulted in nasal injury and 14% mortality supportive of gastroesophageal reflux. Sponsors utilizing formulations containing SLS in toxicity studies in CD-1 mice should exclude gastroesophageal reflux as a confounding factor in studies with morbidity or mortality associated with respiratory distress or evidence of aerophagia.<\/jats:p>","DOI":"10.1177\/01926233211004873","type":"journal-article","created":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T06:00:38Z","timestamp":1620108038000},"page":"1100-1108","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Effects of 0.5% and 2.0% Sodium Lauryl Sulfate in Male CD-1 Mice From a 3-Month Oral Gavage Toxicity Study"],"prefix":"10.1177","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9869-6346","authenticated-orcid":false,"given":"Armando R.","family":"Irizarry Rovira","sequence":"first","affiliation":[{"name":"Department of Pathology, Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim G.","family":"Hilbish","sequence":"additional","affiliation":[{"name":"Nonclinical Safety Assessment, Covance Laboratories Inc, Greenfield, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Schroeder","sequence":"additional","affiliation":[{"name":"Nonclinical Safety Assessment, Covance Laboratories Inc, Madison, WI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary A.","family":"Boorman","sequence":"additional","affiliation":[{"name":"Nonclinical Safety Assessment, Covance Laboratories Inc, Chantilly, VA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelly M.","family":"Credille","sequence":"additional","affiliation":[{"name":"Diagnostic and Experimental Pathology Laboratory, Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Darryl","family":"Ballard","sequence":"additional","affiliation":[{"name":"Diagnostic and Experimental Pathology Laboratory, Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeff C.","family":"Hanson","sequence":"additional","affiliation":[{"name":"Research Informatics, Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Niedenthal","sequence":"additional","affiliation":[{"name":"Nonclinical Study Management, Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2021,5,4]]},"reference":[{"key":"bibr1-01926233211004873","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 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