Preclinical safety evaluation of SloIron CFTN-PS 5: A pea-derived ferritin product

IF 3.9 3区医学 Q2 FOOD SCIENCE & TECHNOLOGY

Food and Chemical Toxicology Pub Date : 2025-02-01 DOI:10.1016/j.fct.2025.115291

Bradley J. Lampe , Margitta Dziwenka , Vincent P. Hackel

{"title":"Preclinical safety evaluation of SloIron CFTN-PS 5: A pea-derived ferritin product","authors":"Bradley J. Lampe , Margitta Dziwenka , Vincent P. Hackel","doi":"10.1016/j.fct.2025.115291","DOIUrl":null,"url":null,"abstract":"<div><div>Ferritins are proteins present in plants and animals that are highly effective in storing iron and maintaining iron homeostasis. Iron deficiency anemia is a widespread nutritional disorder, and plant ferritins (phytoferritin) are potential sources of bioavailable iron with slow-release characteristics that prevent oxidative damage. These characteristics are related to receptor mediated endocytosis, the primary absorption mechanism in humans. However, the available toxicological data are insufficient to determine whether the use of phytoferritin as a nutritional supplement to enhance iron consumption in human populations is safe. Therefore, several GLP-compliant toxicology studies have been conducted with phytoferritin prepared from the seed of <em>Psium sativum</em> (trade name: SloIron CFTN-PS5). SloIron CFTN-PS5 was non-mutagenic and non-clastogenic <em>in vitro</em> and did not induce the formation of micronuclei <em>in vivo</em>. SloIron CFTN-PS5 was well-tolerated in a 90-day subchronic toxicity studies conducted in Sprague-Dawley rats at doses up to 1950 mg/kg bw/day. These findings suggest that the oral consumption of SloIron CFTN-PS5 is of low toxicological concern, with a 90-day oral subchronic No Observed Adverse Effect Level (NOAEL) of 1950 mg/kg-day, the highest dose tested.</div></div>","PeriodicalId":317,"journal":{"name":"Food and Chemical Toxicology","volume":"197 ","pages":"Article 115291"},"PeriodicalIF":3.9000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food and Chemical Toxicology","FirstCategoryId":"97","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0278691525000584","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Ferritins are proteins present in plants and animals that are highly effective in storing iron and maintaining iron homeostasis. Iron deficiency anemia is a widespread nutritional disorder, and plant ferritins (phytoferritin) are potential sources of bioavailable iron with slow-release characteristics that prevent oxidative damage. These characteristics are related to receptor mediated endocytosis, the primary absorption mechanism in humans. However, the available toxicological data are insufficient to determine whether the use of phytoferritin as a nutritional supplement to enhance iron consumption in human populations is safe. Therefore, several GLP-compliant toxicology studies have been conducted with phytoferritin prepared from the seed of Psium sativum (trade name: SloIron CFTN-PS5). SloIron CFTN-PS5 was non-mutagenic and non-clastogenic in vitro and did not induce the formation of micronuclei in vivo. SloIron CFTN-PS5 was well-tolerated in a 90-day subchronic toxicity studies conducted in Sprague-Dawley rats at doses up to 1950 mg/kg bw/day. These findings suggest that the oral consumption of SloIron CFTN-PS5 is of low toxicological concern, with a 90-day oral subchronic No Observed Adverse Effect Level (NOAEL) of 1950 mg/kg-day, the highest dose tested.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Food and Chemical Toxicology 工程技术-毒理学

CiteScore

10.90

自引率

4.70%

发文量

651

审稿时长

31 days

期刊介绍： Food and Chemical Toxicology (FCT), an internationally renowned journal, that publishes original research articles and reviews on toxic effects, in animals and humans, of natural or synthetic chemicals occurring in the human environment with particular emphasis on food, drugs, and chemicals, including agricultural and industrial safety, and consumer product safety. Areas such as safety evaluation of novel foods and ingredients, biotechnologically-derived products, and nanomaterials are included in the scope of the journal. FCT also encourages submission of papers on inter-relationships between nutrition and toxicology and on in vitro techniques, particularly those fostering the 3 Rs. The principal aim of the journal is to publish high impact, scholarly work and to serve as a multidisciplinary forum for research in toxicology. Papers submitted will be judged on the basis of scientific originality and contribution to the field, quality and subject matter. Studies should address at least one of the following: -Adverse physiological/biochemical, or pathological changes induced by specific defined substances -New techniques for assessing potential toxicity, including molecular biology -Mechanisms underlying toxic phenomena -Toxicological examinations of specific chemicals or consumer products, both those showing adverse effects and those demonstrating safety, that meet current standards of scientific acceptability. Authors must clearly and briefly identify what novel toxic effect (s) or toxic mechanism (s) of the chemical are being reported and what their significance is in the abstract. Furthermore, sufficient doses should be included in order to provide information on NOAEL/LOAEL values.