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A 90-day dietary study of a (2R,4R)-monatin salt in Beagle dogs
(2R,4R)-Monatin salt (Na/K) [sodium/potassium (2R,4R)-2-amino-4-carboxy-4-hydroxy-5-(3-indolyl) pentanoate, hereafter “R,R-monatin”] was administered in the diets of groups of Beagle dogs (4/sex/group) at concentrations of 0 (basal diet), 5000, 20,000, or 35,000 ppm for 13 weeks. There were no effec...
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| Published in: | Food and chemical toxicology 2016-05, Vol.91, p.181-190 |
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| container_title | Food and chemical toxicology |
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| creator | Crincoli, Christine M. Brathwaite, Witty A. Rihner, Marisa O. Nikiforov, Andrey I. Harris, Stephen B. Greeley, Melanie A. Eapen, Alex K. |
| description | (2R,4R)-Monatin salt (Na/K) [sodium/potassium (2R,4R)-2-amino-4-carboxy-4-hydroxy-5-(3-indolyl) pentanoate, hereafter “R,R-monatin”] was administered in the diets of groups of Beagle dogs (4/sex/group) at concentrations of 0 (basal diet), 5000, 20,000, or 35,000 ppm for 13 weeks. There were no effects on survival, clinical observations, body weight and body weight gain, feed consumption and feed efficiency, functional observational battery, ophthalmic examination, and electrocardiographic evaluation. No adverse effects on hematology, serum chemistry, and urinalysis parameters were reported. A statistically significant decrease in testicular weights associated with germ cell hypocellularity and reduced luminal sperm in the epididymides was reported in all treated male groups. Based on these findings, the dietary no-observed-adverse-effect level (NOAEL) of R,R-monatin for 90 days was considered 35,000 ppm for female dogs (approximately 1101 mg/kg bw/day) and |
| doi_str_mv | 10.1016/j.fct.2015.08.020 |
| format | article |
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•Beagle dogs were fed diets containing 0, 5000, 20,000, or 35,000 ppm R,R-monatin for 13 weeks.•A statistically significant decrease in testes weights with microscopic correlates was reported in all treated male groups.•The no-observed-adverse-effect level (NOAEL) was determined to be 35,000 ppm for female dogs and <5000 ppm for male dogs.</description><identifier>ISSN: 0278-6915</identifier><identifier>EISSN: 1873-6351</identifier><identifier>DOI: 10.1016/j.fct.2015.08.020</identifier><identifier>PMID: 26334793</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Animals ; Body Weight - drug effects ; Diet ; Dietary ; Dog ; Feeding Behavior - drug effects ; Female ; Glutamic Acid - administration & dosage ; Glutamic Acid - analogs & derivatives ; Indoles - administration & dosage ; Male ; Organ Size - drug effects ; R,R-monatin ; Safety ; Toxicity</subject><ispartof>Food and chemical toxicology, 2016-05, Vol.91, p.181-190</ispartof><rights>2015 Elsevier Ltd</rights><rights>Copyright © 2015 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c338t-e7043888b48c79cbf4a6c1365fc6f704a184c9260b5c36ce3f0a6a8c794039d33</cites><orcidid>0000-0002-7738-1679 ; 0000-0002-0482-9858</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26334793$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Crincoli, Christine M.</creatorcontrib><creatorcontrib>Brathwaite, Witty A.</creatorcontrib><creatorcontrib>Rihner, Marisa O.</creatorcontrib><creatorcontrib>Nikiforov, Andrey I.</creatorcontrib><creatorcontrib>Harris, Stephen B.</creatorcontrib><creatorcontrib>Greeley, Melanie A.</creatorcontrib><creatorcontrib>Eapen, Alex K.</creatorcontrib><title>A 90-day dietary study of a (2R,4R)-monatin salt in Beagle dogs</title><title>Food and chemical toxicology</title><addtitle>Food Chem Toxicol</addtitle><description>(2R,4R)-Monatin salt (Na/K) [sodium/potassium (2R,4R)-2-amino-4-carboxy-4-hydroxy-5-(3-indolyl) pentanoate, hereafter “R,R-monatin”] was administered in the diets of groups of Beagle dogs (4/sex/group) at concentrations of 0 (basal diet), 5000, 20,000, or 35,000 ppm for 13 weeks. There were no effects on survival, clinical observations, body weight and body weight gain, feed consumption and feed efficiency, functional observational battery, ophthalmic examination, and electrocardiographic evaluation. No adverse effects on hematology, serum chemistry, and urinalysis parameters were reported. A statistically significant decrease in testicular weights associated with germ cell hypocellularity and reduced luminal sperm in the epididymides was reported in all treated male groups. Based on these findings, the dietary no-observed-adverse-effect level (NOAEL) of R,R-monatin for 90 days was considered 35,000 ppm for female dogs (approximately 1101 mg/kg bw/day) and <5000 ppm for male dogs (approximately <151 mg/kg bw/day).
•Beagle dogs were fed diets containing 0, 5000, 20,000, or 35,000 ppm R,R-monatin for 13 weeks.•A statistically significant decrease in testes weights with microscopic correlates was reported in all treated male groups.•The no-observed-adverse-effect level (NOAEL) was determined to be 35,000 ppm for female dogs and <5000 ppm for male dogs.</description><subject>Animals</subject><subject>Body Weight - drug effects</subject><subject>Diet</subject><subject>Dietary</subject><subject>Dog</subject><subject>Feeding Behavior - drug effects</subject><subject>Female</subject><subject>Glutamic Acid - administration & dosage</subject><subject>Glutamic Acid - analogs & derivatives</subject><subject>Indoles - administration & dosage</subject><subject>Male</subject><subject>Organ Size - drug effects</subject><subject>R,R-monatin</subject><subject>Safety</subject><subject>Toxicity</subject><issn>0278-6915</issn><issn>1873-6351</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><recordid>eNp9kF1LwzAUhoMobk5_gDeSSwVbT5o2SfFC5vALBsLQ65Am6cjox2xaYf_elE0vvToX53nfw3kQuiQQEyDsbhOXuo8TIFkMIoYEjtCUCE4jRjNyjKaQcBGxnGQTdOb9BgA44ewUTRJGacpzOkUPc5xDZNQOG2d71e2w7wezw22JFb5OVrfp6iaq20b1rsFeVT0O89GqdWWxadf-HJ2UqvL24jBn6PP56WPxGi3fX94W82WkKRV9ZDmkVAhRpELzXBdlqpgmlGWlZmXYKSJSnScMikxTpi0tQTE1sinQ3FA6Q9f73m3Xfg3W97J2XtuqUo1tBy8JF1kynhhRskd113rf2VJuO1eH1yQBOXqTGxm8ydGbBCGDt5C5OtQPRW3NX-JXVADu94ANT34720mvnW20Na6zocy07p_6H8J0efU</recordid><startdate>201605</startdate><enddate>201605</enddate><creator>Crincoli, Christine M.</creator><creator>Brathwaite, Witty A.</creator><creator>Rihner, Marisa O.</creator><creator>Nikiforov, Andrey I.</creator><creator>Harris, Stephen B.</creator><creator>Greeley, Melanie A.</creator><creator>Eapen, Alex K.</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7ST</scope><scope>7U7</scope><scope>C1K</scope><scope>SOI</scope><orcidid>https://orcid.org/0000-0002-7738-1679</orcidid><orcidid>https://orcid.org/0000-0002-0482-9858</orcidid></search><sort><creationdate>201605</creationdate><title>A 90-day dietary study of a (2R,4R)-monatin salt in Beagle dogs</title><author>Crincoli, Christine M. ; Brathwaite, Witty A. ; Rihner, Marisa O. ; Nikiforov, Andrey I. ; Harris, Stephen B. ; Greeley, Melanie A. ; Eapen, Alex K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c338t-e7043888b48c79cbf4a6c1365fc6f704a184c9260b5c36ce3f0a6a8c794039d33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Animals</topic><topic>Body Weight - drug effects</topic><topic>Diet</topic><topic>Dietary</topic><topic>Dog</topic><topic>Feeding Behavior - drug effects</topic><topic>Female</topic><topic>Glutamic Acid - administration & dosage</topic><topic>Glutamic Acid - analogs & derivatives</topic><topic>Indoles - administration & dosage</topic><topic>Male</topic><topic>Organ Size - drug effects</topic><topic>R,R-monatin</topic><topic>Safety</topic><topic>Toxicity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Crincoli, Christine M.</creatorcontrib><creatorcontrib>Brathwaite, Witty A.</creatorcontrib><creatorcontrib>Rihner, Marisa O.</creatorcontrib><creatorcontrib>Nikiforov, Andrey I.</creatorcontrib><creatorcontrib>Harris, Stephen B.</creatorcontrib><creatorcontrib>Greeley, Melanie A.</creatorcontrib><creatorcontrib>Eapen, Alex K.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Environment Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Environment Abstracts</collection><jtitle>Food and chemical toxicology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Crincoli, Christine M.</au><au>Brathwaite, Witty A.</au><au>Rihner, Marisa O.</au><au>Nikiforov, Andrey I.</au><au>Harris, Stephen B.</au><au>Greeley, Melanie A.</au><au>Eapen, Alex K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A 90-day dietary study of a (2R,4R)-monatin salt in Beagle dogs</atitle><jtitle>Food and chemical toxicology</jtitle><addtitle>Food Chem Toxicol</addtitle><date>2016-05</date><risdate>2016</risdate><volume>91</volume><spage>181</spage><epage>190</epage><pages>181-190</pages><issn>0278-6915</issn><eissn>1873-6351</eissn><abstract>(2R,4R)-Monatin salt (Na/K) [sodium/potassium (2R,4R)-2-amino-4-carboxy-4-hydroxy-5-(3-indolyl) pentanoate, hereafter “R,R-monatin”] was administered in the diets of groups of Beagle dogs (4/sex/group) at concentrations of 0 (basal diet), 5000, 20,000, or 35,000 ppm for 13 weeks. There were no effects on survival, clinical observations, body weight and body weight gain, feed consumption and feed efficiency, functional observational battery, ophthalmic examination, and electrocardiographic evaluation. No adverse effects on hematology, serum chemistry, and urinalysis parameters were reported. A statistically significant decrease in testicular weights associated with germ cell hypocellularity and reduced luminal sperm in the epididymides was reported in all treated male groups. Based on these findings, the dietary no-observed-adverse-effect level (NOAEL) of R,R-monatin for 90 days was considered 35,000 ppm for female dogs (approximately 1101 mg/kg bw/day) and <5000 ppm for male dogs (approximately <151 mg/kg bw/day).
•Beagle dogs were fed diets containing 0, 5000, 20,000, or 35,000 ppm R,R-monatin for 13 weeks.•A statistically significant decrease in testes weights with microscopic correlates was reported in all treated male groups.•The no-observed-adverse-effect level (NOAEL) was determined to be 35,000 ppm for female dogs and <5000 ppm for male dogs.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>26334793</pmid><doi>10.1016/j.fct.2015.08.020</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-7738-1679</orcidid><orcidid>https://orcid.org/0000-0002-0482-9858</orcidid></addata></record> |
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| subjects | Animals Body Weight - drug effects Diet Dietary Dog Feeding Behavior - drug effects Female Glutamic Acid - administration & dosage Glutamic Acid - analogs & derivatives Indoles - administration & dosage Male Organ Size - drug effects R,R-monatin Safety Toxicity |
| title | A 90-day dietary study of a (2R,4R)-monatin salt in Beagle dogs |
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