International Journal of Toxicology最新文献

Final Amended Safety Assessment of Octyldodecyl Stearoyl Stearate as Used in Cosmetics. 化妆品中使用的辛基十二烷基硬脂酸酯的最终修订安全性评估。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-10-12 DOI: 10.1177/10915818261494996

Regina Tucker, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan C Tilton, Monice Fiume, Bart Heldreth

引用次数: 0

Safety Assessment of Red Algae-Derived Ingredients as Used in Cosmetics. 化妆品中红藻衍生成分的安全性评价。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-10-09 DOI: 10.1177/10915818261474837

Priya Ferguson, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Susan C Tilton, Monice M Fiume, Bart Heldreth

{"title":"Safety Assessment of Red Algae-Derived Ingredients as Used in Cosmetics.","authors":"Priya Ferguson, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Susan C Tilton, Monice M Fiume, Bart Heldreth","doi":"10.1177/10915818261474837","DOIUrl":"https://doi.org/10.1177/10915818261474837","url":null,"abstract":"The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of red algae-derived ingredients. Sixty red algae-derived ingredients were found in the International Cosmetic Ingredient Dictionary (Dictionary); however, several of these ingredients may be equivalent according to accepted scientific names. These ingredients are mostly reported to function in cosmetics as skin-conditioning agents. Impurities, particularly arsenic, heavy metals, and pesticides, may be present in these ingredients; industry should continue to use good manufacturing practices to monitor and limit these possible impurities. The Panel considered the available data and concluded that 16 red algae-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment. The Panel also concluded that the data are insufficient to make a determination of safety that the remaining 44 ingredients are safe under the intended conditions of use in cosmetic formulations.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"10915818261474837"},"PeriodicalIF":1.3,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136590","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

Case Studies in Identifying and Understanding Seizure Liability in Drug Development. 识别和理解药物开发中扣押责任的案例研究。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-09-28 DOI: 10.1177/10915818261488768

Katie Sokolowski, Simon Authier, Owen McMaster, Brandon Pressly, Brad Bolon, Marcus S Delatte

{"title":"Case Studies in Identifying and Understanding Seizure Liability in Drug Development.","authors":"Katie Sokolowski, Simon Authier, Owen McMaster, Brandon Pressly, Brad Bolon, Marcus S Delatte","doi":"10.1177/10915818261488768","DOIUrl":"https://doi.org/10.1177/10915818261488768","url":null,"abstract":"Drug-induced seizures are among the most frequent safety concerns for neuroactive drug candidates. Currently, no guidelines are defined for interrogating and mitigating seizure liability. Because of the risks to patient safety during clinical trials, improved nonclinical characterization of seizure liability is an area of intense interest among drug developers and regulators. During the 2022 annual meeting of the American College of Toxicology (ACT), a continuing education course titled \"Identifying and Understanding Seizure Liability in Drug Development\" addressed challenges in this field. The course (and now this paper) used a series of detailed nonclinical case studies based on the authors' experiences to illustrate core principles and a flexible menu of methods to evaluate potential seizure liability. Key points to consider include lists of (1) procedures for detecting seizures and defining their mechanisms when performing pivotal and/or investigational toxicity studies; (2) constellations of common neurological findings (functional and structural) that indicate potential seizure liability, and in particular (3) event patterns that warrant an electroencephalographic (EEG) study; and (4) major principles for mitigating seizure liability during clinical trials. Taken together, this approach provides a logical workflow by which nonclinical testing of drug-related seizures may be used to best protect patient safety.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"10915818261488768"},"PeriodicalIF":1.3,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149069659","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

Re-Review Summary of Ascorbic Acid and Ascorbates. 抗坏血酸和抗坏血酸再综述。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-09-22 DOI: 10.1177/10915818261486387

Priya Ferguson, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Samuel M Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan C Tilton, Monice Fiume, Bart Heldreth

引用次数: 0

Safety Assessment of Benzophenones as Used in Cosmetics. 化妆品中二苯甲酮类药物的安全性评价。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-09-21 DOI: 10.1177/10915818261480029

Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Jinqiu Zhu, Monice Fiume, Bart Heldreth

引用次数: 0

Drug-drug Interaction Between Alpinetin and Glimepiride and its Potential Mechanism in Rats. 大鼠肾上腺素与格列美脲的相互作用及其潜在机制。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-09-20 DOI: 10.1177/10915818261472446

Mengnan Qin, Wenwen Zhao, Xin Li

{"title":"Drug-drug Interaction Between Alpinetin and Glimepiride and its Potential Mechanism in Rats.","authors":"Mengnan Qin, Wenwen Zhao, Xin Li","doi":"10.1177/10915818261472446","DOIUrl":"https://doi.org/10.1177/10915818261472446","url":null,"abstract":"Given that alpinetin possesses hypoglycemic and cardioprotective properties, it holds potential for co-administration with the antidiabetic agent glimepiride. The aim was to evaluate the impact of alpinetin on the pharmacokinetics and hypoglycemic efficacy of glimepiride, thereby providing a foundation for the development of alpinetin and informing its potential clinical translation. Pharmacokinetic studies were performed in rats following oral administration of glimepiride (1 mg/kg) alone or combined with alpinetin (30 mg/kg). The effect of the combination of glimepiride and alpinetin on blood glucose levels was investigated in a rat model of type 2 diabetes mellitus (T2DM). In vitro experiments were conducted to evaluate the effect of alpinetin on glimepiride metabolic stability and to assess its role on cytochrome P450 2C9 (CYP2C9) activity. Co-administration of glimepiride with alpinetin resulted in significant changes in the pharmacokinetics of glimepiride, as evidenced by an increase in area under the concentration-time curve (AUC), elimination half-life (t1/2), maximum concentration (Cmax), and a decrease in clearance. Glimepiride in combination with alpinetin enhanced the hypoglycemic effect in T2DM rats. Mechanistic studies in liver microsomes revealed that alpinetin improved glimepiride metabolic stability and inhibited CYP2C9 activity. The combination of glimepiride with alpinetin may increase the systemic exposure of glimepiride through inhibition of CYP2C9 activity. This likely contributes to the enhanced hypoglycemic effect observed, but also underscores the need for caution regarding the potential risk of hypoglycemia.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"10915818261472446"},"PeriodicalIF":1.3,"publicationDate":"2026-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149008350","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

Preclinical Safety Evaluation of Human Lactoferrin Alpha (Effera^®). 人乳铁蛋白α （Effera®）的临床前安全性评价。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-09-18 DOI: 10.1177/10915818261483229

Ross Peterson, Nigel Baldwin, Anthony J Clark, Norbert E Kaminski, Lance Blevins, Alan Hoberman, Rajasekhar Pala, Elise Lewis, Andrea Vaden-Harris, Carrie-Anne Malinczak

{"title":"Preclinical Safety Evaluation of Human Lactoferrin Alpha (Effera®).","authors":"Ross Peterson, Nigel Baldwin, Anthony J Clark, Norbert E Kaminski, Lance Blevins, Alan Hoberman, Rajasekhar Pala, Elise Lewis, Andrea Vaden-Harris, Carrie-Anne Malinczak","doi":"10.1177/10915818261483229","DOIUrl":"10.1177/10915818261483229","url":null,"abstract":"The preclinical safety of human-equivalent lactoferrin alpha (heqLFα; effera®), produced by Komagataella phaffii, was evaluated to support its use as a food ingredient in infant formula and products for young children. Genotoxicity was assessed using a bacterial reverse mutation (Ames) assay in five strains of Salmonella typhimurium and Escherichia coli, and an in vitro micronucleus assay in TK6 cells. Both studies followed OECD guidelines and were conducted up to the recommended limit concentrations (5000 µg/plate and 2000 µg/mL, respectively). A 14-day non-GLP juvenile dose range-finding study and a 13-week GLP juvenile rat toxicity study with a 4-week recovery phase were conducted under ICH S11 guidance. Neonatal Sprague-Dawley rats received heqLFα at 0, 1500, 3000, or 5000 mg/kg body weight/day by twice-daily oral gavage from postnatal day 7 to 98. Bovine lactoferrin (bLF) and whey protein at 5000 mg/kg body weight/day served as reference controls. heqLFα was non-mutagenic and non-clastogenic in both genotoxicity assays. In the 13-week juvenile rat study, no heqLFα-related mortality, clinical signs, developmental, neurobehavioral, or immune toxicity effects were observed. Minor, non-adverse renal findings consistent with high protein intake were observed and largely reversed during recovery. Clinical pathology parameters fully resolved during recovery. Toxicokinetic evaluation showed no systemic accumulation. Based on the absence of toxicologically relevant adverse findings, heqLFα is well tolerated at doses up to 5000 mg/kg body weight/day, establishing a no observed adverse effect level (NOAEL) of 5000 mg/kg/day, the highest dose tested, and supporting its safety across intended populations from birth to adulthood.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"10915818261483229"},"PeriodicalIF":1.3,"publicationDate":"2026-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149001827","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

Fifty Years of the Cosmetic Ingredient Review (CIR) and the Expert Panel for Cosmetic Ingredient Safety: An Independent, Transparent, and Science-Forward Program for Ingredient Safety Assessment. 化妆品成分审查（CIR）和化妆品成分安全专家小组的五十年：一个独立、透明和科学的成分安全评估计划。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-09-15 DOI: 10.1177/10915818261484604

Jinqiu Zhu, Wilma F Bergfeld, Monice Fiume, Bart Heldreth

{"title":"Fifty Years of the Cosmetic Ingredient Review (CIR) and the Expert Panel for Cosmetic Ingredient Safety: An Independent, Transparent, and Science-Forward Program for Ingredient Safety Assessment.","authors":"Jinqiu Zhu, Wilma F Bergfeld, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818261484604","DOIUrl":"https://doi.org/10.1177/10915818261484604","url":null,"abstract":"The Cosmetic Ingredient Review (CIR) program marks its 50th anniversary as an enduring model of independent, transparent, and science-forward evaluation of cosmetic ingredient safety. Established in 1976 by the Personal Care Products Council (PCPC), with the support of the US Food and Drug Administration (FDA) and the Consumer Federation of America (CFA), CIR has completed evidence-based safety assessments for more than 6000 ingredients, with comprehensive findings published in International Journal of Toxicology. Through a defined governance framework, Expert Panel review, and fully public deliberations, CIR conducts safety evaluations via a structured and transparent process that incorporates broad stakeholder engagement. The program has continued to evolve in parallel with global regulatory and methodological advances. CIR remains an independent scientific resource that complements regulatory oversight and supports robust safety substantiation of cosmetic products. In addition, it has increasingly adopted an exposure-driven evaluation paradigm aligned with Next-Generation Risk Assessment (NGRA) principles, integrating validated New Approach Methodologies (NAMs) to inform hazard identification and refine risk characterization while complementing traditional toxicology. Collectively, these efforts promote scientific harmonization and the continued modernization of cosmetic ingredient safety assessment. At 50 years, CIR stands as a globally recognized, science-based, and publicly accountable program, exemplifying independence and advancing integrated, exposure-led, and human-relevant risk assessment consistent with modern regulatory science.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"10915818261484604"},"PeriodicalIF":1.3,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148976541","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

Re-Review Summary of Glyceryl Monoesters: Glyceryl Collagenate, Glyceryl Sesquioleate, Glyceryl/Sorbitol Oleate/Hydroxystearate, Glyceryl Stearate/Maleate, and Glyceryl Thiopropionate - No Use. 甘油单酯：胶原甘油，倍半油酸甘油，甘油/山梨糖醇油酸酯/羟基硬脂酸酯，甘油硬脂酸酯/马来酸酯和甘油硫丙酸酯-无使用。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-09-14 DOI: 10.1177/10915818261486399

Temima Nguyen, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Samuel M Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan C Tilton, Monice Fiume, Bart Heldreth

引用次数: 0

The New Battlefield: Food, Water, and the Evolution of Asymmetric Terror. 新战场：食物，水和不对称恐怖的演变。

IF 1.3 4区医学

International Journal of Toxicology Pub Date : 2026-09-09 DOI: 10.1177/10915818261474825

A Wallace Hayes, Ann M Marini, Peter Pressman

{"title":"The New Battlefield: Food, Water, and the Evolution of Asymmetric Terror.","authors":"A Wallace Hayes, Ann M Marini, Peter Pressman","doi":"10.1177/10915818261474825","DOIUrl":"https://doi.org/10.1177/10915818261474825","url":null,"abstract":"This review examines the historical development of biological warfare from premodern contamination practices to twentieth-century state programs, post-9/11 bioterrorism, and the renewed prominence of biological risk in the COVID-19 era. Drawing on historical, policy, and public-health scholarship, it shows how disease came to be understood not only as a natural threat but also as a strategic instrument shaped by scientific knowledge, military organization, and administrative secrecy. The review traces the transition from empirical uses of contamination in siege warfare and colonial settings to laboratory-based weaponization in the 20th century, including German sabotage during the First World War, Imperial Japan's Unit 731, British anthrax trials on Gruinard Island, and the expansion of United States and Soviet biological warfare programs during the Cold War. It also evaluates the limits of international restraint through the 1925 Geneva Protocol and the 1972 Biological Weapons Convention, emphasizing the persistent problem of verification illustrated by the 1979 Sverdlovsk anthrax outbreak. The analysis then follows the shift from state arsenals to public fear through Aum Shinrikyo and the 2001 anthrax letters before situating epidemic and pandemic disease within the broader politics of biological vulnerability. COVID-19 and gain-of-function research are treated as cases of intensified scrutiny of biosafety, uncertainty, and public mistrust, rather than evidence for any single-origin hypothesis. The review concludes that biological warfare is best understood not solely as the deliberate use of pathogens but as a broader political and institutional phenomenon emerging where scientific capacity, strategic fear, concealment, and social vulnerability converge.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"10915818261474825"},"PeriodicalIF":1.3,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148911784","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