title: The no-observed-adverse-effect level (NOAEL) of baby aloe powder (BAP) for nutraceutical application based upon toxicological evaluation.
abstract: Aloe has been used in versatile herbal medications and nutraceuticals throughout history. Aloe is widely considered to be generally safe for humans and used globally. The effectiveness and pharmacological properties of aloe are dependent upon when the plant is collected. However, little is known about the toxicology of whole-body aloe collected within less than 1 yr. Based upon widespread exposure to aloe, it is important to determine a daily intake level of this chemical to ensure its safety for humans. To determine the no-observed-adverse-effect level (NOAEL) of baby aloe powder (BAP) for clinical application, Sprague-Dawley (SD) rats were treated orally for 4 wk with 4 different concentrations: 0, 0.125, 0.5, and 2 g/kg body weight (bw). In this study, no significant or dose-dependent toxicological effects of BAP were observed in biochemical or hematological parameters, urinalysis, clinical signs, body weight, and food and water consumption. There were changes in some biomarkers in certain treated groups compared to controls; however, all values were within their reference ranges and not dose-dependent. Based on these results, the NOAEL of BAP was estimated to be greater than 2 g/kg bw in male and 2 g/kg bw in female SD rats. Collectively, these data suggest that BAP used in this study did not produce any marked subacute toxic effects up to a maximum concentration of 2 g/kg bw, and thus use in nutraceuticals and in pharmaceutical and cosmetic applications at a concentration of >2 g/kg is warranted.
authors.affiliation: a Department of Biochemistry and Health Science , College of Natural Sciences, Changwon National University , Changwon , Gyeongnam , South Korea.
authors.forename: Seung Jun
authors.initials: SJ
authors.lastname: Kwack
authors.forename: Seon-Gil
authors.initials: SG
authors.lastname: Do
authors.forename: Young Woo
authors.initials: YW
authors.lastname: Kim
authors.forename: Yeon-Joo
authors.initials: YJ
authors.lastname: Kim
authors.forename: Hyo-Min
authors.initials: HM
authors.lastname: Gwak
authors.forename: Hyun Jong
authors.initials: HJ
authors.lastname: Park
authors.forename: Taehyun
authors.initials: T
authors.lastname: Roh
authors.forename: Min Kyung
authors.initials: MK
authors.lastname: Shin
authors.forename: Seong Kwang
authors.initials: SK
authors.lastname: Lim
authors.forename: Hyung Sik
authors.initials: HS
authors.lastname: Kim
authors.forename: Byung-Mu
authors.initials: BM
authors.lastname: Lee
mesh_terms: D000504:Aloe / Q000737:chemistry*; D000818:Animals; D001835:Body Weight; D019587:Dietary Supplements / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D005260:Female; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000502:physiology; D028321:Plant Preparations / Q000008:administration & dosage* / Q000633:toxicity*; D011208:Powders / Q000633:toxicity; D051381:Rats; D017207:Rats, Sprague-Dawley; D016482:Urinalysis
chemical_list: D028321:Plant Preparations; D011208:Powders