Risk assessment of Pyrrolizidine Alkaloid in herbal supplement and tea using margin of exposure approach

ZAINUDIN, AISHAH ZAHIRA (2022) Risk assessment of Pyrrolizidine Alkaloid in herbal supplement and tea using margin of exposure approach. [Project Paper] (Submitted)

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Abstract

Introduction: Herbal supplements and tea are frequently perceived as harmless, natural and effective for health benefit. However, pyrrolizidine alkaloid (PA) which naturally present in plants may induced genotoxicity and carcinogenicity in human. Objectives: This study aimed to assess the risk of PA from herbal supplement and tea using Margin of Exposure (MOE) approach. Methodology: The secondary data related to the presence of PA in herbal supplements and teas and animal toxicological data from exposure to PA was collected from the literature. The estimated daily intake (EDI) of PA from the literature data was calculated for a 70 kg person with recommended daily intake of 200 mg of herbal supplement and 2 g of herbal tea. Animal data on exposure to PA causing liver cancer was collected and analyzed using Benchmark Dose Modelling (BMD) version 3.2 to derive the BMD Lower confidence limit of 10 (BMDL10) as a point of departure. Risk assessment to assess the potential health risk was performed using MOE approach with the ratio of BMDL10 and EDI for lifetime exposure to PAs. Results and Discussion: A total number of 404 herbal supplements and teas contaminated with PA was collected from literature. The PA was found in the herbal supplements and teas ranging from 0.09 to 235376.00 μg/kg. The EDI of PA based on exposure to these samples were ranging from 0.000004 to 10.08 The BMDL10 calculated value was ranging from 176.76 μg/kg bw/day to 272.95 μg/kg bw/day. The calculated MOEs were ranging from 27.05 to 159220833.30 for herbal supplements and 3569.88 to 955325.00 for herbal teas. Out of 385 herbal supplements, 42 samples (10.09%) were below the MOE of 10,000 while out of 19 herbal teas, 4 samples (21.05%) were below the MOE. Conclusion: As conclusion, it shows that most of samples of herbal supplement and herbal teas are presents with PA with an MOE values of less than 10,000 indicating the urge for necessary risk management action to be taken. Keywords: Risk Assessment, Pyrrolizidine Alkaloid, Margin of Exposure , herbal supplement, herbal tea

Item Type:	Project Paper
Faculty:	Faculty of Medicine and Health Science
Depositing User:	Mr Hafizzuddin Hamidon
Date Deposited:	24 Aug 2023 04:35
Last Modified:	24 Aug 2023 04:35
URI:	http://psaspb.upm.edu.my/id/eprint/1136

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