Botanical Safety Consortium Technical Working Groups

Mission: Develop strategies and methodologies to characterize botanical ingredients for safety assessments.

Objectives:

• Prioritize candidates for comprehensive chemical characterization based on other TWGs’ needs.
• Compile existing literature on analytical methods and chemical composition of selected botanicals.
• Select resource-efficient analytical approaches and partners to identify/quantify constituents as needed for safety assessment.

Mission: Develop screening strategies that reliably identify potential developmentally or reproductively toxic botanicals.

Objectives:

• Select in silico and in vitro tools suitable for complex botanical mixtures.
• Select candidate botanicals based on suspected DART toxicity or safety.
• Establish DART case studies to evaluate the utility of a growing toolbox.

Mission: Build a screening strategy to identify hepatotoxic botanicals, inform mechanisms, and characterize “botanicokinetics.”

Objectives:

• Select resource-efficient in silico/in vitro tools for liver potential and ADME properties in complex mixtures.
• Select candidate botanicals based on suspected hepatotoxicity and ADME endpoints.
• Evaluate tools’ potential and limits for predicting/understanding botanical-induced hepatotoxicity.
• Explore drug–botanical interaction potential using candidate methods.

Mission: Develop a screening strategy that reliably identifies potentially genotoxic botanical ingredients.

Objectives:

• Select resource-efficient in silico/in vitro tools to identify genotoxic agents in complex mixtures.
• Recommend criteria for identifying significant genotoxic hazards.
• Select candidate botanicals based on suspected genotoxicity or safety.
• Use case studies to evaluate toolbox reliability vs. in vivo outcomes/exposure (where available).

Mission: Develop tools that identify botanicals with potential to induce adverse effects within multi-compartment biological systems.

Objectives:

• Develop systematic literature review strategies for history/traditional use data.
• Select and leverage multi-compartment in vitro models for systemic safety data.
• Improve IVIVE using toxicokinetic modeling to support safety assessments and margins of safety.

Mission: Develop/apply data analytic methods using in vitro/in silico data for botanical safety/hazard assessment.

Objectives:

• Partner with TWGs on experimental design and analysis support.
• Develop/evaluate/apply methods for “sufficient similarity” of botanicals.
• For selected botanicals, compare in vitro/in silico toxicological profiles vs. traditional animal tests.

Mission: Develop screening strategies that reliably identify potential cardiotoxic botanicals.

Objectives:

• Select in silico/in vitro tools that accommodate complex botanical mixtures.
• Select candidate botanicals based on suspected cardiotoxicity or safety.
• Establish cardiotoxicity case studies to evaluate toolbox usefulness.

Mission: Develop screening strategies that reliably identify potential neurotoxic botanicals.

Objectives:

• Select in silico/in vitro tools suitable for complex mixtures.
• Select candidate botanicals based on suspected neurotoxicity or safety.
• Establish neurotoxicity case studies to evaluate toolbox usefulness.

This expert group advises the BSC on an ad-hoc basis on botanical candidates and sources of botanical information, reviews compiled data/literature, and recommends additional stakeholders to inform the consortium.