Regulatory Toxicology and Pharmacology最新文献_第10页

Matched molecular pairs-driven read-across for the prediction of genotoxicity of plant protection product residues 匹配分子对驱动的跨读预测植保产品残留的遗传毒性

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-08-04 DOI: 10.1016/j.yrtph.2025.105915

S.J. Enoch , Z. Hasarova , M.T.D. Cronin , K. Bridgwood , S. Rao , A. Hueser , F.M. Kluxen , M. Frericks

引用次数: 0

Strengthening next generation risk decision-making: A contemporary review 加强下一代风险决策：当代回顾

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-09-10 DOI: 10.1016/j.yrtph.2025.105939

Yadvinder Bhuller , Raywat Deonandan , Daniel Krewski

{"title":"Strengthening next generation risk decision-making: A contemporary review","authors":"Yadvinder Bhuller , Raywat Deonandan , Daniel Krewski","doi":"10.1016/j.yrtph.2025.105939","DOIUrl":"10.1016/j.yrtph.2025.105939","url":null,"abstract":"<div><div>Risk decision-making inherently requires consideration of fundamental principles and other factors pertinent for addressing important health and environmental risks of concern. The risk decision-making process has evolved from linear frameworks to more integrated and dynamic strategies. A recent scoping review mapped this evolution and demonstrated a transition to more holistic and complex approaches. The term next generation risk decision-making captures these contemporary strategies by incorporating all aspects of risk assessment, management, and communication involved in risk decision-making, thereby going beyond recently articulated next generation risk assessment frameworks. While this scoping review included best practices and ten attributes of risk decision-making, it did not address how to consider these factors when developing strategies for next generation risk decision-making. This contemporary review addresses this limitation by discussing the role of decision theories prior to presenting a model for characterizing, categorizing, and visualizing these ten considerations: foresight and planning, research and development, regulatory, risk, upstream and downstream attributes, risk culture, ONE Health lens, broad regulatory factors, risk management, and risk communication. The realist paradigm-based model and corresponding considerations are then analyzed using a strengths, weaknesses, opportunities, and threats analysis of top-down, bottom-up, and fully integrated risk science strategies to next generation risk decision-making.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"163 ","pages":"Article 105939"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145044766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Estimates of skin and blood concentrations of UV-filters: Insights from in vitro skin experiments 紫外线过滤器的皮肤和血液浓度的估计：来自体外皮肤实验的见解。

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-07-29 DOI: 10.1016/j.yrtph.2025.105916

Hélène P. De Luca , Stéphanie Boudon , Alex Odermatt , Linda Schenk , Nancy B. Hopf

{"title":"Estimates of skin and blood concentrations of UV-filters: Insights from in vitro skin experiments","authors":"Hélène P. De Luca , Stéphanie Boudon , Alex Odermatt , Linda Schenk , Nancy B. Hopf","doi":"10.1016/j.yrtph.2025.105916","DOIUrl":"10.1016/j.yrtph.2025.105916","url":null,"abstract":"<div><div>Organic ultraviolet (UV) filters mitigate radiation transmission through the skin; however, uncertainties persist regarding their ability to cross the skin barrier and induce toxicity. Our aim was to use published <em>in vitro</em> skin permeation studies to predict UV-filter concentrations in blood and skin. In our review, we identified 35 papers reporting <em>in vitro</em> skin permeation of the 12 most used organic UV-filters. We estimated the UV-filters’ theoretical concentrations in blood and skin layers for two case scenarios and compared them with <em>in vivo</em> data. Five of the UV-filters penetrated skin as the parent compound, among these the highest estimated blood concentration was for benzophenone 4 (419 mg/L). These were overestimated (up to 100 times) compared to the reported <em>in vivo</em> results. Ten of the UV-filters permeated skin, among these ethylhexyl salicylate had the highest estimated skin concentration (15.99 g/cm<sup>3</sup>). Results from literature were inconsistent, likely due to different experimental <em>in vitro</em> methods. Although skin can metabolize chemicals, none of the included studies quantified potential UV-filter metabolites. We recommend future <em>in vitro</em> skin permeation studies to standardize the methods according to existing guidelines (including quantification of the metabolites) and screen UV-filters for possible skin absorption followed by a risk evaluation.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"163 ","pages":"Article 105916"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144761128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The dangerous precedent of silencing government science 压制政府科学的危险先例。

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-08-08 DOI: 10.1016/j.yrtph.2025.105927

Martin van den Berg Prof. Dr. ((Co)Editor-in-Chief)

引用次数: 0

Corrigendum to “Acute and 28-days repeated dose sub-acute toxicity study of gallic acid in albino mice” [Regulat. Toxicol. Pharmacol. RTP 101 (2019) 71–78] 《没食子酸对白化小鼠急性和28天重复给药亚急性毒性研究》的勘误表。Toxicol。杂志。RTP 101(2019) 71-78]。

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-08-05 DOI: 10.1016/j.yrtph.2025.105917

Bhavesh C. Variya , Anita K. Bakrania , Prem Madan , Snehal S. Patel

引用次数: 0

Preliminary safety risk assessment of parabens in children's cosmetics sold in China 对羟基苯甲酸酯在中国销售的儿童化妆品中的初步安全风险评估

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-08-30 DOI: 10.1016/j.yrtph.2025.105935

Ren Wang, Cen Chen, Qiaoyuan Cheng, Yuanyang Wu, Linqi Yan, Zhen Xie, Zehua Li, Shanshan Liu, Yongjun Lou

{"title":"Preliminary safety risk assessment of parabens in children's cosmetics sold in China","authors":"Ren Wang, Cen Chen, Qiaoyuan Cheng, Yuanyang Wu, Linqi Yan, Zhen Xie, Zehua Li, Shanshan Liu, Yongjun Lou","doi":"10.1016/j.yrtph.2025.105935","DOIUrl":"10.1016/j.yrtph.2025.105935","url":null,"abstract":"<div><div>Since adverse health outcomes of parabens added in children's cosmetics have been reported, it is important to investigate preliminary risk characteristic assessment of parabens preservatives in children's cosmetics. This study aimed to calculate exposure parameters using a combination experimental data and an exposure assessment tool to make safety assessment for parabens in children's cosmetics. The paraben concentration of different formulation types of 63 products of children's cosmetic products were measured by High Performance Liquid Chromatography. Based on product usage, paraben concentrations, exposure factors, behavioral patterns and exposure routes, the exposure parameters of parabens in children's cosmetics were calculated by mathematical mode from ConsExpo Web. A margin of safety (MoS) was calculated for safety evaluations. Results showed that 4-hydroxybenzoate methyl (MP) was the most commonly used paraben, which was used in 30.2 % of products, followed by propyl 4-hydroxybenzoate (PP) (12.7 %), ethyl 4-hydroxybenzoate (EP) and butyl 4-hydroxybenzoate (BP) both in 1.6 % of products. The concentrations of parabens in the cosmetic products were all within the safety limits required by the SCCS. The exposure to parabens decreased with increasing age in accordance with a published data. The MoS of parabens in children's cosmetics were all more than 100, indicating parabens to be of manageable risk and safe for use.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"163 ","pages":"Article 105935"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144921531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The association between cadmium exposure and the risk of early liver disease: A systematic review and meta-analysis 镉暴露与早期肝病风险之间的关系：一项系统综述和荟萃分析。

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-09-15 DOI: 10.1016/j.yrtph.2025.105942

Hualing Zhang , Yue Jing , Lan Guan , Jianlan Luo , Ming Zeng

{"title":"The association between cadmium exposure and the risk of early liver disease: A systematic review and meta-analysis","authors":"Hualing Zhang , Yue Jing , Lan Guan , Jianlan Luo , Ming Zeng","doi":"10.1016/j.yrtph.2025.105942","DOIUrl":"10.1016/j.yrtph.2025.105942","url":null,"abstract":"<div><div>Currently, liver diseases are considered to be one of the most prevalent diseases that jeopardize people's health. Existing studies have found that heavy metal cadmium (Cadmium, Cd) exposure is associated with liver disease, but the results of studies on the risk of cadmium on liver disease are inconsistent. In order to further investigate the relationship between cadmium exposure and the risk of early liver disease in the population, this study was conducted by searching PubMed, Cochrane Library, Web of Science, CNKI and Wanfang databases and performing meta-analysis of the relevant literature, so as to systematically evaluate the effect of cadmium exposure on the risk of liver disease. A total of 5201 relevant articles were retrieved. Based on inclusion and exclusion criteria, 25 articles were included in the meta-analysis. Review Manager 5.4 was used for quality assessment, with most studies rated as low risk of bias. Heterogeneity testing showed significant results (<em>P</em> < 0.05). Meta-analysis showed that cadmium exposure increased the risk of elevated liver enzymes (OR = 1.38, 95 % CI: 1.27–1.50), MAFLD (OR = 1.14, 95 % CI: 1.07–1.22) and liver fibrosis (OR = 1.39, 95 % CI: 1.14–1.70). Sensitivity analysis and publication bias detection indicated that the results were reliable. Therefore, the conclusion of this study is that environmental cadmium exposure increases the risk of liver disease, and the extent and dose of cadmium exposure in the population should be further controlled.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"163 ","pages":"Article 105942"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145081476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Challenges and opportunities of read-across for the tumor promotion effects of microcystins 微囊藻毒素促肿瘤作用的解读挑战与机遇。

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-09-11 DOI: 10.1016/j.yrtph.2025.105938

Cynthia B. Pestana , Daniela Morais Leme , Enzo Zini Moreira Silva , Sahra Kiessig , James W. Firman , Carsten Kneuer , Philip Marx-Stoelting , Mark T.D. Cronin

{"title":"Challenges and opportunities of read-across for the tumor promotion effects of microcystins","authors":"Cynthia B. Pestana , Daniela Morais Leme , Enzo Zini Moreira Silva , Sahra Kiessig , James W. Firman , Carsten Kneuer , Philip Marx-Stoelting , Mark T.D. Cronin","doi":"10.1016/j.yrtph.2025.105938","DOIUrl":"10.1016/j.yrtph.2025.105938","url":null,"abstract":"<div><div>The microcystins (MCs) are a family of cyclic oligopeptides toxins expressed in at least 30 cyanobacterial species and are liable to pose significant hazard to human health due to hepatotoxicity. Microcystin-leucine arginine (MC-LR) is the most extensively studied and toxic congener and classified as possibly carcinogenic to humans based on tumor promotion activity in the liver. Given the substantial toxicity data gaps for the MCs, read-across was assessed to evaluate the tumor promotion effects of a series of data-poor MC congeners based on <em>in vivo</em> information for MC-LR as the source molecule. Lines of evidence from <em>in silico</em> estimates of structural similarity, physico-chemical properties, hepatotoxicity, genotoxic and carcinogenicity were compiled to support the filling of data gaps. Uncertainties were evaluated according to scenario 4 of the European Chemicals Agency's (ECHA's) Read-Across Assessment Framework (RAAF). The read-across process followed a previously proposed harmonized framework to apply the common principles together with information from new approach methodologies (NAMs). Lines of evidence were consistent across the MC congeners and the uncertainties were found to be acceptable for data gap filling. Read-across strategies, with known caveats and restrictions, were shown to be applicable for large, complex molecules such as the MCs.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"163 ","pages":"Article 105938"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145058456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Permeation studies of chlorpyrifos through skin and synthetic membranes to improve the in vitro dermal absorption assay of lipophilic compounds with ethanolic receptors 毒死蜱通过皮肤和合成膜的渗透研究，以改善具有乙醇受体的亲脂化合物的体外皮肤吸收测定

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-08-23 DOI: 10.1016/j.yrtph.2025.105931

Dorinda Marques-da-Silva , Margarida Franco , Cristiana Violante , Ricardo Lagoa

{"title":"Permeation studies of chlorpyrifos through skin and synthetic membranes to improve the in vitro dermal absorption assay of lipophilic compounds with ethanolic receptors","authors":"Dorinda Marques-da-Silva , Margarida Franco , Cristiana Violante , Ricardo Lagoa","doi":"10.1016/j.yrtph.2025.105931","DOIUrl":"10.1016/j.yrtph.2025.105931","url":null,"abstract":"<div><div>The <em>in vitro</em> percutaneous absorption assay is standardized, but the common use of 50 % ethanol in the receptor compartment for lipophilic compounds is questioned. In parallel, the demand for animal-free methodologies is driving the application of synthetic membranes without standardization guidelines. To address these issues, this study investigated the permeation of the lipophilic compound chlorpyrifos using different ethanol-containing receptor fluids with human and pig skin <em>ex vivo</em>, and silicone and STRAT-M® membranes. The results considered several factors, particularly chlorpyrifos solubility and the contact angles between skin models and receptor fluids. Original experimental approaches demonstrated that ethanol from the receptor rapidly crosses to the donor compartment increasing chlorpyrifos diffusivity. Compared to the described <em>in vivo</em> dermal absorption, human skin and STRAT-M® yielded the best predictive permeation parameters. However, high percentage of ethanol in the receptor fluid can lead to an overestimation of percutaneous absorption. Summing up, it is important to carefully determine the concentration of ethanol to be used in the receptor fluid of lipophilic compounds’ assays while further research with synthetic membranes is needed prior to their wider adoption.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"163 ","pages":"Article 105931"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144919993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A new method of consistency evaluation of brain drugs: a case study of edaravone 脑药物一致性评价新方法——以依达拉奉为例。

IF 3.5 4区医学

Regulatory Toxicology and Pharmacology Pub Date : 2025-12-01 Epub Date: 2025-08-30 DOI: 10.1016/j.yrtph.2025.105933

Liqiang Gu , Yanping Hu , Yinfang Lai , Sheng Zhang , Haoran Wang , Xiaozhen Xu , Lingfang Chen , Yuhua Shi , Jiechao Chen , Xiaochun Sun , Yuan Zhang , Lingzhi Hu

{"title":"A new method of consistency evaluation of brain drugs: a case study of edaravone","authors":"Liqiang Gu , Yanping Hu , Yinfang Lai , Sheng Zhang , Haoran Wang , Xiaozhen Xu , Lingfang Chen , Yuhua Shi , Jiechao Chen , Xiaochun Sun , Yuan Zhang , Lingzhi Hu","doi":"10.1016/j.yrtph.2025.105933","DOIUrl":"10.1016/j.yrtph.2025.105933","url":null,"abstract":"<div><div>Bioequivalence test is typically conducted by determining the drug concentration in plasma. However, this is not suitable for brain drugs (like Edaravone) that have targets in CNS. The amount of a drug in target site in the CNS is responsible for its activity in the brain, while the concentration of a drug in the blood has a weak impact on the CNS. In this paper, a new consistency evaluation method for brain drugs was established. 16 rats were divided into two groups. One group was administered the test preparation, and the other group was administered the control preparation. Then, cerebrospinal fluid (CSF) samples were collected. All of the CSF samples were examined by LC-MS. The 90 % confidence interval of the geometric mean ratio of AUC<sub>0-t</sub> was 90.30–150.59 %, and 91.79–211.06 % for C<sub>max</sub>. In addition, the result indicated that the two preparations were not bioequivalent in the CNS, although the concentration-time profile and pharmacokinetic parameters were quite similar. The results revealed the particularity and complexity of the bioequivalence test for brain drugs that have targets in the CNS. The feasibility of the test was confirmed, and our results provide useful information for the consistency evaluation of brain drugs.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"163 ","pages":"Article 105933"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144966519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0