Srilakshmi Aluri¹*, Anzar CA¹, Joseph MV¹, Faizal Mohamed², Bineesh Eranimose¹ and Vadiraj Bharadwaj¹

¹Research and Development Centre, Ingex Botanicals Limited Nelamangala, Bangalore, 562123, India
²Bio-Actives Japan Corporation, BAJ Building Toshima-KU, 171-0052, Japan

*Corresponding Author: Srilakshmi Aluri, Research and Development Centre, Ingex Botanicals Limited Nelamangala, Bangalore, 562123, India.

Received: October 13, 2025; Published: October 27, 2025

Abstract

Mucuna pruriens (L.) DC., (Velvet bean), is a legume known for its high protein content and the neuroprotective compound notably L-DOPA. Despite their potential nutraceutical applications and traditional uses, thorough toxicological studies on protein concentrates still remain scarce. This study evaluated the acute and sub-acute oral toxicity of Mucuna Protein 80% following OECD guidelines in Wistar rats. No mortality and adverse effects were observed in single dose acute toxicity (2000 mg/kg) placing the protein in unclassified or category 5 under the Global Harmonized system. No significant behavioral or clinical toxicity signs were demonstrated at Sub acute repeated dosing (1000 and 2000 mg/kg) over 28 days. Quantification of anti-nutrient factors in Mucuna protein were also carried out and was found to be only in negligible amounts. Biochemical, Hematological and histopathological analysis indicated safety at the dosages tested and only minor dose-dependent increase in mean corpuscular hemoglobin at 2000 mg/kg and minor increase in basophil at 1000 mg/kg without any signs of kidney and liver toxicity. Organ weights remain constant and reveal normal structure. Overall study presented No Observed Adverse Effect Level (NOAEL) exceeding 2000 mg/kg. This supports the safety of Mucuna protein 80% for utilization in functional foods and nutraceuticals and establishes a scientific basis for its safe commercialization in accordance with regulatory standards.

Keywords: Acute Toxicity; Mucuna pruriens; Nutraceuticals; Phytochemicals; Sub-Acute Toxicity

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Citation

Citation: Srilakshmi Aluri., et al. “Preclinical Safety and Toxicological Evaluation of Mucuna Protein (80%) Via Acute and Sub-Acute Oral Toxicity Studies". Acta Scientific Pharmaceutical Sciences 9.11 (2025): 25-41.

Copyright

Copyright: © 2025 Srilakshmi Aluri., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.