Developing an approach for evaluating the cardiotoxic potential of botanicals

Area of Science:

• Toxicology
• Cardiovascular Research
• Botanical Science

Background:

• Botanicals are widely used for health benefits but often lack rigorous pre-market toxicity testing.
• Assessing botanical cardiotoxicity is challenging due to complex mixtures and variability.
• Adverse cardiac events, though rare, highlight the need for robust safety assessments.

Purpose of the Study:

• To outline the Botanical Safety Consortium (BSC) Cardiotoxicity Working Group's strategy for evaluating New Approach Methodologies (NAMs).
• To identify and refine NAMs for assessing the potential cardiotoxicity of botanical products.
• To advance the application of NAMs in regulatory toxicology for botanical safety.

Main Methods:

• Utilizing *in vitro* models, including human-induced pluripotent stem cell-derived cardiomyocytes.
• Employing techniques such as microelectrode arrays, voltage and calcium optical mapping, contractile force measurement, and mitochondrial function assays.
• Applying these NAMs to well-characterized botanical extracts as case studies.

Main Results:

• The BSC is developing a toolkit for high-throughput, human-relevant cardiotoxicity screening of botanicals.
• The approach leverages advanced *in vitro* assays to evaluate botanical effects on cardiovascular function.
• This work establishes a foundation for improved botanical safety assessment practices.

Conclusions:

• NAMs provide efficient, cost-effective, and human-relevant solutions for evaluating botanical cardiotoxicity.
• The BSC's work aims to enhance the safety assessment of widely consumed botanical products.
• Refined NAMs will support regulatory toxicology and improve consumer safety.