A Comprehensive Safety Assessment of Algae Protein from Picochlorum for Human Consumption.

IF 3 4区 医学 Q1 MEDICINE, LEGAL Regulatory Toxicology and Pharmacology Pub Date : 2024-11-28 DOI:10.1016/j.yrtph.2024.105753
Tomal Dattaroy, Manish R Shukla
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Abstract

The current trend happens to be that consumers are seeking nourishing, high quality sustainable protein sources to meet their nutritional needs, thus establishing a clear intent to broaden their protein horizon. Microalgae protein holds great promise in becoming the next vegan protein option. In the present study, protein extracted from the microalga Picochlorum maculatum has been thoroughly evaluated for its safety for human consumption through a battery of in-vivo and in-vitro tests. Bacterial reverse mutation assay indicates that the test substance is non-mutagenic and studies comprising of in-vitro chromosomal aberration test and the in-vivo mammalian micronucleus test showed that the test item is non-clastogenic, and therefore, lacks genotoxicity. Based the results of an acute oral toxicity study, the test item can be classified as "Category 5" as designated in a globally harmonized system for classification of chemicals. Further, 28-day and 90-day repeated dose oral toxicity studies did not result in any mortality or morbidity throughout the experimental period; none of the animal groups used in the study showed any abnormal clinical signs, establishing a "No Observed Adverse Effect Level" of Algae Protein Powder at 3000 mg kg bw-1. Moreover, the test item exhibited a positive impact on growth in test animals. Computational studies established extremely low allergenic potential of the test item.

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人类食用Picochlorum藻类蛋白的安全性综合评价。
目前的趋势是,消费者正在寻求营养丰富、高质量的可持续蛋白质来源,以满足他们的营养需求,从而建立了一个明确的意图,以扩大他们的蛋白质视野。微藻蛋白有望成为下一个纯素蛋白的选择。在本研究中,通过一系列体内和体外试验,对从微藻Picochlorum maculatum中提取的蛋白质进行了全面的安全性评估,以供人类食用。细菌反突变试验表明该试验物质不具有诱变性,体外染色体畸变试验和哺乳动物体内微核试验研究表明该试验项目不具有致裂性,因此不具有遗传毒性。根据急性口服毒性研究的结果,该测试项目可根据全球统一的化学品分类系统归类为“第5类”。此外,28天和90天的重复剂量口服毒性研究在整个实验期间没有导致任何死亡率或发病率;本研究使用的动物组均未出现任何异常临床症状,建立了3000 mg kg bw-1的藻类蛋白粉“未观察到不良反应水平”。此外,测试项目对实验动物的生长表现出积极的影响。计算研究证实该测试项目极低的致敏潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.70
自引率
8.80%
发文量
147
审稿时长
58 days
期刊介绍: Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health. Types of peer-reviewed articles published: -Original research articles of relevance for regulatory aspects covering aspects including, but not limited to: 1.Factors influencing human sensitivity 2.Exposure science related to risk assessment 3.Alternative toxicological test methods 4.Frameworks for evaluation and integration of data in regulatory evaluations 5.Harmonization across regulatory agencies 6.Read-across methods and evaluations -Contemporary Reviews on policy related Research issues -Letters to the Editor -Guest Editorials (by Invitation)
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