A proposed evaluation of new approach methodologies for dermal toxicity assessment of botanicals.

IF 6 3区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Pharmaceutical Biology Pub Date : 2026-12-01 Epub Date: 2026-08-18 DOI:10.1080/13880209.2026.2717803

Julie Krzykwa, Allison Hilberer, Karin Ames, Cécile Bascoul, WanYun Cheng, Rachel Doerer, Stefan Gafner, Dori Germolec, Hilva Gjoni, Shomit Nazare, Argel Islas-Robles, Çiğdem Kahraman, Isabelle Lee, Hans Raabe, Phillip Wages, Donna Webster, Hong Xie, Constance A Mitchell, Gertrude-Emilia Costin

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引用次数: 0

Abstract

Background: Botanicals are widely used in topical formulations for cosmetics, hair care, and personal care products, reflecting consumer interest in plant-derived materials. Their complex and variable composition, presents challenges for traditional toxicological approaches developed for single chemicals. Although many botanicals are well tolerated, reports of skin irritation, sensitization, and phototoxicity highlight the need for reliable approaches to identify dermal hazards and evaluate risk. Established in silico, in chemico, and in vitro test methods, often referred to as New Approach Methodologies (NAMs), may offer efficient and mechanistically informed tools.

Objective: The Dermal Working Group within the Botanical Safety Consortium (BSC) developed a strategy for evaluating existing NAMs for assessing dermal toxicity endpoints in botanicals, using literature evidence and data-rich botanicals to inform assay selection and anticipated performance. This narrative review describes the literature-based considerations used to select candidate assays and characterized reference botanicals for subsequent experimental evaluation.

Methods: This narrative review describes considerations in the selection and application of in vitro and in chemico assays addressing skin irritation (OECD TG 439), phototoxicity (OECD TG 432), and skin sensitization (OECD TG 442 C, 442D, and 442E), together with in silico approaches.

Results & discussion: A set of reference botanicals spanning a range of expected outcomes, from botanicals not expected to have effects to known irritants, sensitizers, and phototoxicants, was chosen to provide a foundation for evaluating assay performance and identifying technical considerations.

Conclusion: This manuscript describes the botanicals and assays being evaluated as part of the BSC's planned dermal toxicity work. The goal of this work is to investigate the utility of NAMs for dermal safety evaluations of botanicals.

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植物性皮肤毒性评价新方法的评价建议。

背景：植物药广泛用于化妆品、护发和个人护理产品的局部配方，反映了消费者对植物来源材料的兴趣。它们的复杂多变的组成，对传统的单一化学品毒理学方法提出了挑战。尽管许多植物药耐受性良好，但关于皮肤刺激、致敏和光毒性的报道强调需要可靠的方法来识别皮肤危害和评估风险。建立在计算机、化学和体外的测试方法，通常被称为新方法方法（NAMs），可以提供有效和机械信息的工具。目的：植物安全联盟（BSC）内的皮肤工作组制定了一项评估现有NAMs的策略，用于评估植物药物的皮肤毒性终点，使用文献证据和丰富的植物药物数据来为检测选择和预期性能提供信息。这篇叙述性综述描述了基于文献的考虑，用于选择候选分析和特征参考植物，以进行后续的实验评估。方法：这篇叙述性综述描述了在选择和应用体外和化学分析时的考虑因素，包括皮肤刺激（经合组织TG 439）、光毒性（经合组织TG 432）和皮肤致敏（经合组织TG 442 C、442D和442E），以及硅方法。结果和讨论：选择了一组参考植物药，涵盖了一系列预期结果，从预计不会产生效果的植物药到已知的刺激物、致敏剂和光毒性，为评估分析性能和确定技术考虑因素提供了基础。结论：这份手稿描述了作为BSC计划的皮肤毒性工作的一部分，正在评估的植物药和测定。本研究的目的是研究NAMs在植物药皮肤安全性评价中的应用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Biology 医学-药学

CiteScore

6.70

自引率

2.60%

发文量

191

审稿时长

1 months

期刊介绍： Pharmaceutical Biology will publish manuscripts describing the discovery, methods for discovery, description, analysis characterization, and production/isolation (including sources and surveys) of biologically-active chemicals or other substances, drugs, pharmaceutical products, or preparations utilized in systems of traditional medicine. Topics may generally encompass any facet of natural product research related to pharmaceutical biology. Papers dealing with agents or topics related to natural product drugs are also appropriate (e.g., semi-synthetic derivatives). Manuscripts will be published as reviews, perspectives, regular research articles, and short communications. The primary criteria for acceptance and publication are scientific rigor and potential to advance the field.