Caroline V L Moreira, John Ogbu, Kadja L C Monteiro, Thiago M de Aquino, Edeildo F da Silva-Júnior, Alberto S S Filho, Hamilton B Napolitano, Christianah A Elusiyan, Renê O do Couto, Elson A Costa, James O Fajemiroye
{"title":"审查下的联苯菊酯:在监管空白中重新审视毒理学证据。","authors":"Caroline V L Moreira, John Ogbu, Kadja L C Monteiro, Thiago M de Aquino, Edeildo F da Silva-Júnior, Alberto S S Filho, Hamilton B Napolitano, Christianah A Elusiyan, Renê O do Couto, Elson A Costa, James O Fajemiroye","doi":"10.1002/jat.4929","DOIUrl":null,"url":null,"abstract":"<p><p>Despite growing health concerns, bifenthrin (BF) remains widely used for controlling agricultural and residential pests. However, different perspectives on its toxicological profile and regulatory framework warrant a revisit and update on BF regulation towards a robust risk-safety assessment. Out of 4102 search outputs, only 62 studies on BF disposition and biological effects met screening and eligibility criteria. Our findings demonstrate oral, dermal, and inhalation toxicity of BF. Studies suggest potential effects, including immunotoxic, endocrine, and reproductive effects, but lack multi-level substantiation and modeling approaches amidst risk biases. Emerging evidence of anxiogenic, depression-like, and Parkinsonian-like effects, which implicate monoaminergic, metabolic, and enzymatic pathways, supports the involvement of several molecular culprits beyond voltage-gated channel disruption. Toxicity concerns raised by the Food and Agriculture Organization-World Health Organization (FAO/WHO), the United States Environmental Protection Agency (USEPA), and the European Food Safety Authority (EFSA) inform the establishment of reference doses of 0.01, 0.03, and 0.031 mg/kg per day, respectively. While the USEPA considers the current toxicological and safety benchmarks adequate for approved uses, it identified potential acute risks of concern to pollinators and terrestrial invertebrates, leading to precautionary labeling measures. In contrast, the EFSA has questioned the reliability of toxicological data and recommended lowering maximum residue levels. Regulatory disparities are traceable to variations in the study designs and risk assessments. While emerging data on behavioral and neurochemical changes may warrant a regulatory reevaluation of BF's toxicological data, integrating predictive models and other new approach methodologies, using high-quality designs, may address current regulatory gaps and inconsistencies.</p>","PeriodicalId":15242,"journal":{"name":"Journal of Applied Toxicology","volume":" ","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Bifenthrin Under Scrutiny: Revisiting Toxicological Evidence Amid Regulatory Gaps.\",\"authors\":\"Caroline V L Moreira, John Ogbu, Kadja L C Monteiro, Thiago M de Aquino, Edeildo F da Silva-Júnior, Alberto S S Filho, Hamilton B Napolitano, Christianah A Elusiyan, Renê O do Couto, Elson A Costa, James O Fajemiroye\",\"doi\":\"10.1002/jat.4929\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Despite growing health concerns, bifenthrin (BF) remains widely used for controlling agricultural and residential pests. However, different perspectives on its toxicological profile and regulatory framework warrant a revisit and update on BF regulation towards a robust risk-safety assessment. Out of 4102 search outputs, only 62 studies on BF disposition and biological effects met screening and eligibility criteria. Our findings demonstrate oral, dermal, and inhalation toxicity of BF. Studies suggest potential effects, including immunotoxic, endocrine, and reproductive effects, but lack multi-level substantiation and modeling approaches amidst risk biases. Emerging evidence of anxiogenic, depression-like, and Parkinsonian-like effects, which implicate monoaminergic, metabolic, and enzymatic pathways, supports the involvement of several molecular culprits beyond voltage-gated channel disruption. Toxicity concerns raised by the Food and Agriculture Organization-World Health Organization (FAO/WHO), the United States Environmental Protection Agency (USEPA), and the European Food Safety Authority (EFSA) inform the establishment of reference doses of 0.01, 0.03, and 0.031 mg/kg per day, respectively. While the USEPA considers the current toxicological and safety benchmarks adequate for approved uses, it identified potential acute risks of concern to pollinators and terrestrial invertebrates, leading to precautionary labeling measures. In contrast, the EFSA has questioned the reliability of toxicological data and recommended lowering maximum residue levels. Regulatory disparities are traceable to variations in the study designs and risk assessments. While emerging data on behavioral and neurochemical changes may warrant a regulatory reevaluation of BF's toxicological data, integrating predictive models and other new approach methodologies, using high-quality designs, may address current regulatory gaps and inconsistencies.</p>\",\"PeriodicalId\":15242,\"journal\":{\"name\":\"Journal of Applied Toxicology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-09-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Applied Toxicology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/jat.4929\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"TOXICOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Applied Toxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/jat.4929","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"TOXICOLOGY","Score":null,"Total":0}
Bifenthrin Under Scrutiny: Revisiting Toxicological Evidence Amid Regulatory Gaps.
Despite growing health concerns, bifenthrin (BF) remains widely used for controlling agricultural and residential pests. However, different perspectives on its toxicological profile and regulatory framework warrant a revisit and update on BF regulation towards a robust risk-safety assessment. Out of 4102 search outputs, only 62 studies on BF disposition and biological effects met screening and eligibility criteria. Our findings demonstrate oral, dermal, and inhalation toxicity of BF. Studies suggest potential effects, including immunotoxic, endocrine, and reproductive effects, but lack multi-level substantiation and modeling approaches amidst risk biases. Emerging evidence of anxiogenic, depression-like, and Parkinsonian-like effects, which implicate monoaminergic, metabolic, and enzymatic pathways, supports the involvement of several molecular culprits beyond voltage-gated channel disruption. Toxicity concerns raised by the Food and Agriculture Organization-World Health Organization (FAO/WHO), the United States Environmental Protection Agency (USEPA), and the European Food Safety Authority (EFSA) inform the establishment of reference doses of 0.01, 0.03, and 0.031 mg/kg per day, respectively. While the USEPA considers the current toxicological and safety benchmarks adequate for approved uses, it identified potential acute risks of concern to pollinators and terrestrial invertebrates, leading to precautionary labeling measures. In contrast, the EFSA has questioned the reliability of toxicological data and recommended lowering maximum residue levels. Regulatory disparities are traceable to variations in the study designs and risk assessments. While emerging data on behavioral and neurochemical changes may warrant a regulatory reevaluation of BF's toxicological data, integrating predictive models and other new approach methodologies, using high-quality designs, may address current regulatory gaps and inconsistencies.
期刊介绍:
Journal of Applied Toxicology publishes peer-reviewed original reviews and hypothesis-driven research articles on mechanistic, fundamental and applied research relating to the toxicity of drugs and chemicals at the molecular, cellular, tissue, target organ and whole body level in vivo (by all relevant routes of exposure) and in vitro / ex vivo. All aspects of toxicology are covered (including but not limited to nanotoxicology, genomics and proteomics, teratogenesis, carcinogenesis, mutagenesis, reproductive and endocrine toxicology, toxicopathology, target organ toxicity, systems toxicity (eg immunotoxicity), neurobehavioral toxicology, mechanistic studies, biochemical and molecular toxicology, novel biomarkers, pharmacokinetics/PBPK, risk assessment and environmental health studies) and emphasis is given to papers of clear application to human health, and/or advance mechanistic understanding and/or provide significant contributions and impact to their field.