一个全面的安全评估,用于人类消费的藻类蛋白质从Picochlorum
1, Tomal Dattaroy1, Manish R Shukla1
1Synthetic Biology Research and Development Group, Reliance Industries Limited, Reliance Technology Group R&D Centre, Reliance Corporate Park, Ghansoli, Navi Mumbai, Maharashtra 400701 India.
Regulatory toxicology and pharmacology : RTP
|November 30, 2024
概括
来自Picochlorum maculatum的微藻蛋白对人类消费是安全的. 严格的测试证实它是非变异性的,非克拉斯托基的,并且具有较低的过敏原潜力,支持其作为可持续的素食蛋白质来源的使用.
科学领域:
- 食品科学 食品科学 食品科学
- 毒理学 毒理学 毒理学
- 生物技术是生物技术.
背景情况:
- 越来越多的消费者对可持续的,高质量的蛋白质来源的需求.
- 微藻蛋白正在成为一个有前途的纯素替代品.
- 需要对新型蛋白质成分进行安全评估.
研究的目的:
- 为了评估从Picochlorum maculatum中提取的蛋白质用于人类消费的安全性.
- 评估微藻蛋白的基因毒性,急性和重复剂量口服毒性以及过敏原潜力.
- 为藻类蛋白粉建立一个没有观察到的不良影响水平 (NOAEL).
主要方法:
- 在体外试验:细菌逆变异检测,染色体异常检测.
- 在体内测试:哺乳动物微核试验,急性口服毒性研究,28天和90天重复剂量口服毒性研究.
- 用于评估过敏原潜在的计算分析.
主要成果:
- 微藻蛋白被发现是非变异性和非类菌性,表明没有基因毒性.
- 急性口服毒性将该物质归类为"第5类" (全球协调系统).
- 在重复剂量研究中,没有观察到不良影响水平 (NOAEL) 确定为3000 mg/kg bw−1,对动物生长产生积极影响和极低的过敏原潜力.
结论:
- 来自Picochlorum maculatum的蛋白质是安全的人类消费.
- 微藻蛋白显示出有利的毒理学特征和低的过敏性潜力.
- 这种蛋白质来源支持可持续和营养丰富的素食选择的不断增长的市场.
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