دورية أكاديمية
A botanical reference set illustrating a weight of evidence approach for skin sensitization risk assessment.
| العنوان: | A botanical reference set illustrating a weight of evidence approach for skin sensitization risk assessment. |
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| المؤلفون: | Gao Y; Procter & Gamble Technology (Beijing) Co., Ltd., Beijing, China. Electronic address: Gao.yu.2@pg.com., Ryan CA; ToxTech Solutions, LLC, Milan, IN, USA., Ellingson K; Procter & Gamble, Mason Business Center, 8700 Mason Montgomery Road, Mason, OH, 45040, USA., Krutz N; Procter & Gamble Services Company NV, Strombeek-Bever, Belgium., Kern PS; Procter & Gamble Services Company NV, Strombeek-Bever, Belgium. |
| المصدر: | Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association [Food Chem Toxicol] 2024 Feb; Vol. 184, pp. 114413. Date of Electronic Publication: 2023 Dec 19. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 8207483 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-6351 (Electronic) Linking ISSN: 02786915 NLM ISO Abbreviation: Food Chem Toxicol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Exeter : Elsevier Science Ltd Original Publication: Oxford ; New York : Pergamon Press, c1982- |
| مواضيع طبية MeSH: | Cosmetics*/toxicity , Biological Products*/pharmacology, Animals ; Humans ; Consumer Product Safety ; Skin ; Risk Assessment ; Plant Extracts/toxicity |
| مستخلص: | Recent years have seen an increase in the use of botanicals and natural substances (BNS) in consumer products such as cosmetics and household care products. Most work conducted to date to assess botanicals for human safety has focused their use as dietary supplements and thus on systemic toxicity. However, the induction of skin sensitization is a possible adverse effect of natural products in particular those that come into skin contact, especially for cosmetics that remain on the skin and are not rinsed off following use. Assessments of BNS ingredients are often challenging for a number of reasons: the BNS are complex mixtures that can be of mostly unknown composition; the composition can be highly variable even within the same plant species and dependent on how processed; the physical form of the BNS raw material can vary from a highly concentrated powdered extract to a liquid extract containing only a small percentage of the BNS; testing of the BNS raw materials in New Approach Methods (NAM) has uncertainty as these methods are often not developed or validated for complex mixtures. In this study, a reference set of 14 selected BNS which span the range of skin sensitization potential was complied. These data were used in a Weight of Evidence (WoE) approach to evaluate their skin sensitization potential with each of the data rich BNS being classified as either having strong evidence of inducing skin sensitization based on human topical use history, animal data, clinical data, composition data and NAM data, or having some but more limited (weak) evidence of inducing skin sensitization, or having strong evidence of no skin sensitization potential. When available data have sufficient potency related information, sensitization potency assessment is also provided based on WoE, classifying these BNS as either strong, moderate, or weak sensitizers, or non-sensitizers. An outline for a BNS skin sensitization risk assessment framework is proposed starting with exposure-based waiving and WoE assessment for higher exposures. In addition to demonstrating the application of the WoE approach, the reference set presented here provides a set of 'data rich' botanicals which cover a range of sensitization potencies that could be used for evaluating existing test methods or aid in the development of new predictive models for skin sensitization. Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2023 Elsevier Ltd. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Botanical; Natural substance; Risk assessment; Skin sensitization; Weight of evidence (WoE) |
| المشرفين على المادة: | 0 (Cosmetics) 0 (Biological Products) 0 (Plant Extracts) |
| تواريخ الأحداث: | Date Created: 20231221 Date Completed: 20240129 Latest Revision: 20240129 |
| رمز التحديث: | 20240129 |
| DOI: | 10.1016/j.fct.2023.114413 |
| PMID: | 38128687 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1873-6351 |
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| DOI: | 10.1016/j.fct.2023.114413 |