Regulatory Toxicology and Pharmacology最新文献_第8页

Development of a digital tool for semi-quantitative assessment of pesticide exposure risk in greenhouses 开发用于温室农药暴露风险半定量评估的数字工具。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-21 DOI: 10.1016/j.yrtph.2025.105975

Pablo Fernández del Olmo, Julián Sánchez-Hermosilla, Ángel Callejón-Ferre, Marta Gómez-Galán, José Pérez-Alonso

Accurate assessment of occupational exposure to plant protection products in greenhouses poses specific challenges due to confined environments, operator variability, and the limited suitability of existing models under real working conditions. This study presents the development of a digital tool that implements a semi-quantitative model for evaluating pesticide exposure risk among greenhouse workers. The model integrates task-specific variables across four exposure scenarios: mixing and loading, application, maintenance and re-entry; and applies a logarithmic scoring system to calculate an exposure index. This index is then combined with a toxicity score derived from product hazard classifications to obtain a comprehensive risk level, interpreted using a five-tier classification scheme with corresponding preventive recommendations. The application includes a preliminary questionnaire to ensure basic safety conditions are met and incorporates an automated update mechanism that maintains an up-to-date list of authorized products based on official registries. The tool was developed with a focus on usability and structured logic, supporting efficient data entry and interpretability of results. Field testing was carried out in different greenhouses under commercial production located in southeast Spain, confirming the coherence and functionality of the tool under practical conditions.

由于环境的限制、操作人员的可变性以及现有模型在实际工作条件下的有限适用性，对温室植物保护产品职业暴露的准确评估提出了具体的挑战。本研究提出了一种数字工具的开发，该工具实现了评估温室工人农药暴露风险的半定量模型。该模型集成了四种暴露场景中的特定任务变量：混合和加载、应用程序、维护和重新进入；并应用对数评分系统来计算暴露指数。然后将该指数与从产品危害分类中得出的毒性评分相结合，以获得综合风险水平，使用具有相应预防建议的五层分类方案进行解释。该申请包括一份初步调查问卷，以确保满足基本的安全条件，并包含一个自动更新机制，根据官方注册表维护最新的授权产品清单。该工具的开发重点是可用性和结构化逻辑，支持有效的数据输入和结果的可解释性。在西班牙东南部的不同温室进行了现场测试，验证了该工具在实际条件下的一致性和功能性。

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引用次数: 0

Exposure and disease burden of fumonisins and aflatoxins from sorghum consumption in Ethiopia 埃塞俄比亚食用高粱中伏马菌素和黄曲霉毒素的暴露和疾病负担。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-14 DOI: 10.1016/j.yrtph.2025.105966

J.A. Sadik , N. Fentahun , I.D. Brouwer , M. Tessema , H.J.van der Fels-Klerx

Studies on mycotoxin exposure from sorghum consumption and related public health risk estimation are rarely available in Ethiopia. The aim of this research was to assess fumonisin and aflatoxin exposure of adults through sorghum consumption in the Amhara National Regional State (ANRS) and at national level in Ethiopia and to estimate related health risks. Data on fumonisin and aflatoxin concentrations in sorghum samples were collected from a survey and literature. Estimated fumonisin exposure in the ANRS and at national level were below the FAO/WHO limit of 2000 ng/kg bw day to be considered a health concern. The estimated aflatoxin exposure levels in the ANRS and at national level fall below the Margin of Exposure value of 10000, indicating potential health concern. The incidence of hepatocellular carcinoma due to aflatoxin exposure in the ANRS ranges from 0.0003 to 0.017 while at national level, it ranges from 0.181 to 8.47 (per100.000 persons/year). The related disability-adjusted life years estimates for the ANRS and at national level ranged from 0.0003 to 0.019 and 0.204 to 11.230, respectively. Aflatoxin exposures were driven more by sorghum intake than aflatoxin contamination. Dietary intervention could further reduce the health risk estimates.

在埃塞俄比亚，很少有关于食用高粱引起的霉菌毒素暴露和相关公共卫生风险评估的研究。本研究的目的是评估阿姆哈拉民族地区州（ANRS）和埃塞俄比亚国家一级成年人通过食用高粱接触伏马菌素和黄曲霉毒素的情况，并估计相关的健康风险。高粱样品中伏马菌素和黄曲霉毒素浓度的数据从调查和文献中收集。在ANRS和国家一级估计的伏马菌素暴露量低于粮农组织/世卫组织每天2000纳克/公斤体重被视为健康问题的限值。在ANRS和国家一级估计的黄曲霉毒素暴露水平低于10000的暴露限度值，表明潜在的健康问题。在ANRS中，黄曲霉毒素暴露导致的肝细胞癌发病率为0.0003至0.017，而在全国水平上，这一发病率为0.181至8.47（每10万人/年）。ANRS和国家水平的相关残疾调整寿命年估计值分别在0.0003至0.019和0.204至11.230之间。与黄曲霉毒素污染相比，高粱摄入量更能驱动黄曲霉毒素暴露。饮食干预可以进一步降低健康风险估计。

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引用次数: 0

Quantitative next generation risk assessment for skin sensitization - application of regression models based on in vitro data to estimate point of departure 定量下一代皮肤致敏风险评估-应用基于体外数据的回归模型来估计起点。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-14 DOI: 10.1016/j.yrtph.2025.105964

Isabelle Lee , Mihwa Na , Maura Lavelle , Isabella Schember , Marissa A. Guttenberg , G Frank Gerberick , Andreas Natsch , Cindy Ryan , Anne Marie Api

Quantitative risk assessment (QRA) for dermal sensitization is essential for determining safe concentrations of skin sensitizers in consumer products. The fragrance industry developed the QRA2 approach, which uses the No Expected Sensitization Induction Level (NESIL) as a starting reference dose or point of departure (PoD). Animal alternatives for potency assessment have emerged to calculate quantitative PoDs. One such alternative is in vitro-based regression models.

Herein, a framework for incorporating regression models into next-generation risk assessment (NGRA) is presented. The framework begins with hazard assessment using in vitro methods (OECD Guideline 497), followed by PoD calculation through regression models, and completed with QRA2. After determining a PoD, uncertainty factors may be considered to derive a new approach methodology NESIL (NAM-NESIL). Case studies are presented with two sensitizers, p-mentha-1,8-dien-7-al (CAS # 2111-75-3) and 3-propylidenephthalide (CAS # 17369-59-4), calculating acceptable exposure levels (AELs) for products like deodorants and bar soaps. Ratios of the AELs to consumer exposure levels (CELs) were then calculated to determine whether the current use is safe. Comparison of QRA based on NAM-NESILs to historically human-derived NESILs supports the reliability of in vitro models. This approach offers a promising alternative for PoD derivation, potentially eliminating the dependence on in-vivo data.

皮肤致敏的定量风险评估（QRA）对于确定消费品中皮肤致敏剂的安全浓度至关重要。香料行业开发了QRA2方法，该方法使用无预期致敏诱导水平（NESIL）作为起始参考剂量或出发点（PoD）。已经出现了用于效价评估的动物替代品来计算定量pod。其中一种选择是基于体外的回归模型。本文提出了一个将回归模型纳入下一代风险评估（NGRA）的框架。该框架首先使用体外方法进行危害评估（OECD指南497），然后通过回归模型计算PoD，最后使用QRA2完成。在确定PoD后，考虑不确定性因素可以推导出一种新的方法NESIL （NAM-NESIL）。案例研究采用两种致敏剂，对薄荷-1,8-二烯-7-al （CAS # 2111-75-3）和3-丙基酞（CAS # 17369-59-4），计算除臭剂和肥皂等产品的可接受暴露水平（AELs）。然后计算AELs与消费者暴露水平（CELs）的比率，以确定当前的使用是否安全。基于NAM-NESILs的QRA与历史上人类来源的NESILs的比较支持体外模型的可靠性。这种方法为PoD衍生提供了一种有希望的替代方法，有可能消除对动物数据或确认性人体测试的需求。

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引用次数: 0

Using read-across to identify isobutylparaben as an endocrine disruptor 使用读取识别对羟基苯甲酸异丁酯为内分泌干扰物。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-13 DOI: 10.1016/j.yrtph.2025.105965

Hanna KL. Johansson, Anna Kjerstine Rosenmai, Julie Boberg, Monica K. Draskau, Marie Louise Holmer, Terje Svingen, Marta Axelstad

引用次数: 0

Evaluating the ability of defined approaches to predict the human skin sensitisation potential of chemicals previously untested in new approach methodologies 评估已定义的方法预测以前未在新方法方法中测试的化学品的人体皮肤致敏潜力的能力。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-13 DOI: 10.1016/j.yrtph.2025.105963

Martyn L. Chilton , Tasha Jones , Adrian Fowkes , Donna S. Macmillan , Darren Kidd

Much progress has been made in the development and validation of New Approach Methodologies (NAMs) for assessing skin sensitisation, as part of the global move away from animal testing. While there are now numerous in silico models and in chemico/in vitro assays available, none are currently thought to be a one-for-one replacement for the animal tests, but rather several NAMs are combined within a Defined Approach (DA), such as those described in OECD guideline 497. In this study, 22 chemicals were chosen which have known human sensitisation potential, but which have not previously been tested in NAMs, to the best of the authors’ knowledge. New in chemico/in vitro data were generated for each chemical in three assays, and this was combined with in silico predictions from two models to generate predictions from four DAs. The data was used to assess the performance of the individual NAMs and DAs within a less well understood area of chemical space, and to learn more about their applicability domains. The newly generated data are made available herein in the expectation that they will be useful to others who are developing and/or validating DAs which assess the risk of chemicals causing human skin sensitisation.

作为全球从动物试验转向动物试验的一部分，在评估皮肤致敏的新方法方法（NAMs）的开发和验证方面取得了很大进展。虽然现在有许多可用的计算机模型和化学/体外测定，但目前没有一种被认为是动物试验的一对一替代，而是在确定方法（DA）中结合了几种nama，例如经合组织指南497中描述的方法。在这项研究中，据作者所知，选择了22种已知具有人类致敏潜力的化学物质，但这些化学物质以前没有在NAMs中进行过测试。在三次分析中为每种化学物质生成新的化学/体外数据，并将其与来自两个模型的计算机预测相结合，从四个DAs中生成预测。这些数据被用来评估单个NAMs和da在化学空间中不太为人所知的区域的性能，并更多地了解它们的适用领域。在此提供新生成的数据，期望它们对正在开发和/或验证评估化学物质引起人体皮肤致敏风险的DAs的其他人有用。

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引用次数: 0

Occupational asthma: dust exposure as a contributory factor and implications for classification of respiratory sensitisers 职业性哮喘：粉尘暴露作为一个促成因素和对呼吸道致敏物分类的影响。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-13 DOI: 10.1016/j.yrtph.2025.105962

Mark A. Pemberton , Ian Kimber

Occupational asthma (AO) is an important chronic respiratory disease associated with airway narrowing. Chemicals that cause OA are regulated under the UN GHS endpoint of respiratory sensitisation. Such chemicals are typically identified using evidence suggesting work-related exposure resulting in the ab initio development of asthma, rather than simply aggravating pre-existing asthma (work exacerbated asthma; WEA). There exist predisposing and aggravating factors within and outside the workplace that influence the development and severity of the disease. Inhalation exposure to dusts is one factor and is recognised as directly causing respiratory disease, and also aggravating pre-existing disease, including asthma. Here the contribution of dusts to the development of work-related asthma has been re-examined with reference to published clinical case studies. The data reveal a link between exposure to dusts and OA, suggesting an additional role of dust in this respect may be the presentation of irritant or sensitising agents in a way that promotes the development of OA, even under conditions where exposure to those agents alone does not. We propose that the significance of co-exposure to dusts may be currently under-estimated in health management of OA, clinical identification of chemicals suspected of causing OA, and classification of true respiratory sensitisers.

职业性哮喘（AO）是一种与气道狭窄相关的重要慢性呼吸系统疾病。引起OA的化学物质受联合国GHS呼吸道致敏终点的管制。这些化学物质通常是通过证据来确定的，这些证据表明与工作有关的接触会导致哮喘从头开始发展，而不是简单地加重已有的哮喘（工作加剧哮喘；WEA）。工作场所内外存在诱发和加重因素，影响疾病的发展和严重程度。吸入粉尘是一个因素，被认为是直接导致呼吸系统疾病的因素，也会加重已有的疾病，包括哮喘。在这里，粉尘对与工作相关的哮喘的发展的贡献已经参照已发表的临床病例研究进行了重新检查。数据揭示了接触粉尘与OA之间的联系，表明粉尘在这方面的另一个作用可能是以促进OA发展的方式呈现刺激性或致敏剂，即使在单独接触这些剂不会产生这种作用的情况下也是如此。我们认为，目前在OA的健康管理、疑似导致OA的化学物质的临床鉴定以及真正的呼吸致敏物分类方面，共暴露于粉尘的重要性可能被低估了。

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引用次数: 0

Comprehensive study of radon levels, health risks, and physiochemical properties in tap water consumed in Iraqi Kurdistan using solid-state nuclear track detectors 使用固态核径迹探测器对伊拉克库尔德斯坦饮用自来水中的氡水平、健康风险和理化性质进行全面研究。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-10 DOI: 10.1016/j.yrtph.2025.105960

Hiwa Mohammad Qadr , Najeba Farhad Salih , Alla Ahmed Muhamad Amin

Water quality assessment represents a fundamental component of public health surveillance programs. Radon concentrations in potable water constitute a significant contributor to environmental contamination and radiological exposure pathways. Consequently, this investigation quantified radon concentrations in tap water samples collected from the Ranya region of Iraqi Kurdistan, utilizing passive detection methodology employing CR-39 solid-state nuclear track detectors. Radiological safety and physicochemical properties of the tap water were evaluated. Measured radon concentrations exhibited a range of 0.068–0.194 Bq L⁻¹, with a mean of 0.107 Bq L⁻¹. All concentrations remained substantially below established regulatory thresholds of 11.1 Bq L⁻¹ for USEPA and 100 Bq L⁻¹ for WHO guidelines. In addition, the maximum annual effective doses from ²²²Rn ingestion were 4.143, 4.888, and 8.167 μSv y⁻¹ for adults, children, and infants, respectively. Children and adults received lower annual effective doses than infants, though all age groups remained well below the WHO safety threshold of 100 μSv y⁻¹. Cancer risk estimates for all age groups also remained below global reference levels. A strong positive correlation was not found between ²²²Rn levels and tap water parameters. It appears that the results dispel local fears of significant radioactive risks by showing that radon concentrations are within the limits set by international organizations.

水质评估是公共卫生监测项目的基本组成部分。饮用水中的氡浓度是造成环境污染和辐射照射途径的一个重要因素。因此，本研究采用采用CR-39固态核径迹探测器的被动检测方法，对从伊拉克库尔德斯坦兰亚地区收集的自来水样品中的氡浓度进行了量化。对自来水的放射安全性和理化性质进行了评价。测得的氡浓度范围为0.068 ~ 0.194 Bq L-1，平均值为0.107 Bq L-1。所有浓度仍大大低于美国环保署规定的11.1 Bq -1和世卫组织准则规定的100 Bq -1的规定阈值。另外，222Rn对成人、儿童和婴儿的最大年有效剂量分别为4.143、4.888和8.167 μSv -1。儿童和成人接受的年有效剂量低于婴儿，但所有年龄组仍远低于世卫组织100 μSv -1的安全阈值。所有年龄组的癌症风险估计值也低于全球参考水平。222Rn水平与自来水参数之间没有明显的正相关关系。结果显示，氡浓度在国际组织规定的限度之内，似乎消除了当地对重大放射性风险的担忧。

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引用次数: 0

Safe usage levels of aqueous Hippophae rhamnoides fruit extract in cosmetics estimated by threshold of toxicological concern, point of departure, and history of safe consumption 根据毒理学关注阈值、起始点和安全消费历史估计化妆品中沙棘果提取物的安全使用水平。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-10 DOI: 10.1016/j.yrtph.2025.105961

Hyejeon Cho , Ye Ji Koo , Seung Ha Lee , Seungjin Bae , Jaeyun Choi , Kyung-Min Lim

Botanical ingredients pose challenges to cosmetic safety assessors due to complex and variable composition. We estimated the safe usage levels of aqueous Hippophae rhamnoides fruit extract (HRFE) in cosmetics using Threshold of Toxicological Concern (TTC), Point of Departure (PoD) estimation, and history of safe consumption approaches. Skin and eye irritation and genotoxicity of HRFE were excluded through in vitro tests, first. The safe usage level of HRFE was estimated using TTC approach through identifying 85 constituents accounting for 98.46 % of HRFE on mass basis, and calculating systemic exposure dosage levels. PoD from the rodent 90-day oral repeated-dose toxicity study and history of safe food consumption of Hippophae rhamnoides fruit were also utilized to derive safe usage levels of HRFE in cosmetics. Maximum safe usage levels of HRFE were estimated to be 0.125 mg/kg bw/day (extract powder), 0.5 mg/kg bw/day, and 166 mg/kg bw/day with TTC, PoD and history of safe consumption approach respectively, showing that TTC is the most conservative and history of safe consumption, the least. However, questions of material equivalence and route-difference remained for PoD and history of safe consumption. Collectively, this study may help to understand the pros and cons of current safety assessment methodologies for botanical ingredients.

植物性成分由于其复杂多变的组成，给化妆品安全性评估带来了挑战。我们使用毒理学关注阈值（TTC）、起始点（PoD）估计和安全消费方法的历史来估计水基沙棘果提取物（HRFE）在化妆品中的安全使用水平。首先通过体外实验排除HRFE对皮肤和眼睛的刺激及遗传毒性。采用TTC法，鉴定出占HRFE质量98.46%的85种成分，并计算出全身暴露剂量水平，估算出HRFE的安全使用水平。此外，还利用啮齿类动物90天口服重复剂量毒性研究和沙棘果安全食用史中的PoD，得出了HRFE在化妆品中的安全使用水平。以TTC、PoD和安全食用史方法估计HRFE的最大安全用量分别为0.125 mg/kg bw/day（提取粉）、0.5 mg/kg bw/day和166 mg/kg bw/day，表明TTC最保守，安全食用史最少。然而，材料等效和路线差异的问题仍然存在于PoD和安全消费的历史。总的来说，这项研究可能有助于了解目前植物成分安全性评估方法的优缺点。

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引用次数: 0

Mode of action analysis for induction of mouse lung tumors by permethrin: Involvement of CYP2F2 enzyme and human relevancy 氯菊酯诱导小鼠肺肿瘤的作用模式分析：CYP2F2酶的参与与人的相关性。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-10-04 DOI: 10.1016/j.yrtph.2025.105958

Dai Hasegawa , Kensuke Kawamoto , Keiko Ogata , Satoki Fukunaga , Samuel M. Cohen , Hiroyuki Asano

Permethrin increases the incidence of bronchiolo-alveolar adenomas in female mice. The proposed mode of action (MOA) for permethrin-induced lung tumorigenesis involves increased mitogenesis in Club cells. Additionally, CYP2F2, which is particularly expressed in mouse lung Club cells and different from human CYP2F1, is considered to be a key factor in mouse-specific lung tumorigenesis. In this study, we investigated the relationship between permethrin-induced mouse lung tumorigenesis and CYP2F2 in CYP2f2 knockout (KO) mice. Fluensulfone and isoniazid were selected as positive controls. We showed that the increased proliferation of Club cells and increased proliferation of smooth endoplasmic reticulum (SER) within them were abolished in permethrin-treated CYP2f2 KO mice, while these changes were clearly observed in permethrin- and positive control-treated wild type mice. Additionally, the disappearance of the Club cell reaction was also observed in positive control-treated CYP2f2 KO mice. Based on these results, it was concluded that CYP2F2 is essential in the MOA of mouse lung tumorigenesis by permethrin, also suggesting that permethrin metabolism by CYP2F2 corresponds to a chain of early key events, including the molecular initiating event (MIE). Furthermore, the data suggested that CYP2F2 played a crucial role in mouse lung tumorigenesis induced by isoniazid, which is known to cause lung tumors in mice but not in humans. The collective data on permethrin-treated mouse lung tumorigenesis, including findings from this study, would lead to the conclusion that the lung tumors induced by permethrin treatment are mouse-specific and not relevant to human lung cancer risk.

氯菊酯增加雌性小鼠细支气管肺泡腺瘤的发病率。氯菊酯诱导肺肿瘤发生的作用模式（MOA）涉及俱乐部细胞有丝分裂的增加。此外，与人CYP2F1不同，CYP2F2在小鼠肺俱乐部细胞中特别表达，被认为是小鼠特异性肺肿瘤发生的关键因素。在本研究中，我们研究了氯菊酯诱导的小鼠肺肿瘤发生与CYP2F2敲除（KO）小鼠的CYP2F2之间的关系。阳性对照选用氟砜和异烟肼。我们发现，在氯菊酯处理的CYP2f2 KO小鼠中，俱乐部细胞增殖的增加和细胞内光滑内质网（SER）增殖的增加被消除，而这些变化在氯菊酯处理和阳性对照的野生型小鼠中被清楚地观察到。此外，在阳性对照处理的CYP2f2 KO小鼠中也观察到俱乐部细胞反应的消失。综上所述，CYP2F2在氯菊酯致小鼠肺肿瘤发生的MOA中起重要作用，并提示CYP2F2代谢氯菊酯的早期关键事件包括分子启动事件（MIE）。此外，数据表明CYP2F2在异烟肼诱导的小鼠肺肿瘤发生中起着至关重要的作用，已知异烟肼在小鼠中引起肺肿瘤，但在人类中没有。氯菊酯处理小鼠肺肿瘤发生的总体数据，包括本研究的发现，将得出结论，氯菊酯处理诱导的肺肿瘤是小鼠特异性的，与人类肺癌风险无关。

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引用次数: 0

Chemical characterization and toxicological evaluation of acrylic-based dental implant devices used for different purposes within the scope of ISO 10993 ISO 10993范围内用于不同用途的丙烯酸基牙科植入装置的化学特性和毒理学评价。

IF 3.5 4区医学 Q1 MEDICINE, LEGAL

Regulatory Toxicology and Pharmacology

Pub Date : 2025-09-27 DOI: 10.1016/j.yrtph.2025.105949

Tuğçe Kuruca , Deniz Demir , Esin Akarsu , Murat Akarsu

Medical devices have the potential to release chemical constituents, either as residual manufacturing additives or as leachable under clinical conditions, which may pose potential toxicological risks. Therefore, comprehensive chemical characterization is crucial to identify and quantify extractable compounds that could migrate from the device during clinical use, in accordance with ISO 10993 standards.

This study provides a comprehensive chemical characterization and toxicological risk assessment of acrylic-based dental devices intended for various clinical applications. By adhering to ISO 10993–12:2021 for extraction protocols and employing both polar (water) and apolar (50:50 ethanol-water) solvents, leachable were analyzed after 72-h incubations at 50 °C. Fourier Transform Infrared Spectroscopy (FTIR) confirmed the use of polymethyl methacrylate (PMMA) in device matrices, while thermogravimetric analysis (TGA) revealed the presence of inorganic pigments.

Extractable compounds were identified by using a broad range of analytical techniques-including Gas Chromatography-Mass Spectrometry (GC-MS), High Performance Liquid Chromatography (HPLC), UV–VIS–NIR Spectrophotometry because of extractable studies, Liquid Chromatography – Tandem Mass Spectrometry (LC-MS/MS) and Inductively Coupled Plasma–Optical Emission Spectrometry (ICP-OES) techniques, detecting compounds such as phenyl benzoate, N,N-dimethyl-p-toluidine, benzoyl peroxide, ethylene glycol dimethacrylate, and benzoic acid. Toxicological risk assessments were subsequently conducted in accordance with ISO 10993–17:2023, demonstrating that all tested devices were biocompatible and posed no toxicological hazard under intended clinical conditions.

医疗器械有可能释放化学成分，作为残留的制造添加剂或在临床条件下可浸出，这可能构成潜在的毒理学风险。因此，根据ISO 10993标准，全面的化学表征对于识别和量化临床使用期间可能从设备迁移的可提取化合物至关重要。本研究提供了用于各种临床应用的丙烯酸基牙科器械的综合化学特性和毒理学风险评估。通过遵循ISO 10993- 12:21 21提取方案，并采用极性（水）和极性（50:50乙醇-水）溶剂，在50°C下培养72小时后分析可浸出性。傅里叶变换红外光谱（FTIR）证实了在器件基质中使用了聚甲基丙烯酸甲酯（PMMA），而热重分析（TGA）显示了无机颜料的存在。可提取化合物通过广泛的分析技术进行鉴定，包括气相色谱-质谱（GC-MS），高效液相色谱（HPLC），紫外-可见-近红外分光光度法（因为可提取研究），液相色谱-质谱（LC-MS/MS）和电感耦合等离子体质谱（ICP-OES）技术，检测化合物如苯甲酸苯酯，N，N-二甲基-对甲苯胺，过氧化苯甲酰，乙二醇二甲基丙烯酸酯，还有苯甲酸。随后根据ISO 10993-17:2023进行毒理学风险评估，证明所有测试设备具有生物相容性，并且在预期的临床条件下不构成毒理学危害。

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引用次数: 0