International Journal of Toxicology最新文献_第7页

Safety Assessment of Trialkyl Trimellitates as Used in Cosmetics. 化妆品中使用的三烷基三甲酸酯的安全评估。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-02-01 Epub Date: 2023-12-30 DOI: 10.1177/10915818231224248

Monice M Fiume, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Lillian J Gill, Bart Heldreth

引用次数: 0

Safety Assessment of Hops as Used in Cosmetics. 化妆品中使用啤酒花的安全性评估。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-02-01 Epub Date: 2023-12-21 DOI: 10.1177/10915818231221796

Lillian Becker, Ivan Boyer, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth

{"title":"Safety Assessment of Hops as Used in Cosmetics.","authors":"Lillian Becker, Ivan Boyer, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231221796","DOIUrl":"10.1177/10915818231221796","url":null,"abstract":"The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Humulus Lupulus (Hops) Extract (reported functions include antimicrobial agent and hair conditioning agent) and Humulus Lupulus (Hops) Oil (reported function is fragrance). The Panel reviewed the relevant data related to these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. For these ingredients, the Panel was concerned about the presence of 8-prenylnaringenin, β-myrcene, and quercetin in cosmetics, which could result in estrogenic effects, dermal irritation, and genotoxicity, respectively. Industry should use current good manufacturing practices to limit impurities and constituents of concern. The Panel concluded that Humulus Lupulus (Hops) Extract and Humulus Lupulus (Hops) Oil are safe in cosmetics in the present practices of use and concentration when formulated to be non-sensitizing.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138829720","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

Safety Assessment of Alkyl Sultaines as Used in Cosmetics. 化妆品中使用的烷基舒他宁的安全性评估。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-02-01 Epub Date: 2023-12-21 DOI: 10.1177/10915818231221791

Christina L Burnett, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth

引用次数: 0

Book Review: Hayes’ Principles and Methods of Toxicology 7th Edition 书评：海斯的《毒理学原理与方法》第 7 版

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-01-03 DOI: 10.1177/10915818231224870

Elliot B. Gordon

引用次数: 0

The Nonclinical Assessment of Trans-1,3,3,3-tetrafluoropropene (HFO-1234ze (E)), a Near Zero Global Warming Potential Propellant for Use in Metered Dose Inhalation Products. 反-1,3,3,3-四氟丙烯（HFO-1234ze（E））的非临床评估，这是一种用于计量剂量吸入产品的近零全球变暖潜能推进剂。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-01-01 Epub Date: 2023-10-20 DOI: 10.1177/10915818231206025

Paul S Giffen, Joanne D Kilgour, Matthew Jacobsen, Karen Thacker, Ann A Holmberg

{"title":"The Nonclinical Assessment of Trans-1,3,3,3-tetrafluoropropene (HFO-1234ze (E)), a Near Zero Global Warming Potential Propellant for Use in Metered Dose Inhalation Products.","authors":"Paul S Giffen, Joanne D Kilgour, Matthew Jacobsen, Karen Thacker, Ann A Holmberg","doi":"10.1177/10915818231206025","DOIUrl":"10.1177/10915818231206025","url":null,"abstract":"HFO-1234ze (E) is proposed as a near zero global warming propellant for use in metered dose inhaled (MDI) products. This paper describes the non-clinical safety assessment in mice, rats, and dogs and supplements previously reported data (genetic toxicology, short-term toxicology, and reproductive toxicology). In all species, HFO-1234ze (E) was only detectable in blood for a short period after dosing with no evidence of accumulation. HFO-1234ze (E) was without any toxicological effects at very high doses in subchronic (13-week mouse) and chronic (39-week dog) studies. Chronic (26-week) administration to rats at very high doses was associated with an exacerbation of rodent progressive cardiomyopathy, a well-documented background finding in rodents. In a 2-generation study, extremely high doses were associated with the early euthanasia of some lactating female rats. This finding was considered to be significantly influenced by a state of negative energy balance, reflecting the specific vulnerability of rats during lactation. These findings are considered to not pose a risk to humans with typical MDI use given they occurred at doses which far exceed those expected in patients. Overall, the nonclinical safety data for HFO-1234ze (E) support its further development as an MDI propellant.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49677418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Preclinical Safety Evaluation of the Human-Identical Milk Oligosaccharide Lacto-N-Triose II. 人乳低聚糖乳糖-N-三糖的临床前安全性评价II。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-01-01 Epub Date: 2023-09-28 DOI: 10.1177/10915818231203515

Xu Fang, Wei Zhu, Huiying Zhao, Wencheng Yin, Xiao Song, Fengxin Liu

{"title":"Preclinical Safety Evaluation of the Human-Identical Milk Oligosaccharide Lacto-N-Triose II.","authors":"Xu Fang, Wei Zhu, Huiying Zhao, Wencheng Yin, Xiao Song, Fengxin Liu","doi":"10.1177/10915818231203515","DOIUrl":"10.1177/10915818231203515","url":null,"abstract":"Lacto-N-triose II (LNT II), an essential human milk oligosaccharide and precursor to lacto-N-tetraose (LNT) and lacto-N-neotetraose (LNnT), was evaluated for safety. Genotoxicity was assessed through in vitro tests including Bacterial Reverse Mutation Test and mammalian cell micronucleus test, and a subchronic oral gavage toxicity study was conducted on juvenile Sprague-Dawley rats. In this study, LNT II was administered at dose levels of 0, 1,500, 2,500, or 5,000 mg/kg body weight (bw)/day for 90 days, followed by a 4-week treatment-free recovery period. LNT II was non-genotoxic in the in vitro assays. No compound-related effects were observed across all dosage levels based on various measures, including clinical observations, body weight gain, feed consumption, clinical pathology, organ weights, and histopathology. Consequently, the highest dosage of 5,000 mg/kg bw/day was established as the no-observed-adverse-effect-level (NOAEL). These results suggest the safe use of LNT II in young children formula and as a food ingredient, within the limits found naturally in human breast milk.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41096770","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

An Evaluation of Zebrafish, an Emerging Model Analyzing the Effects of Toxicants on Cognitive and Neuromuscular Function. 斑马鱼的评估，一种分析毒物对认知和神经肌肉功能影响的新兴模型。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-01-01 Epub Date: 2023-10-30 DOI: 10.1177/10915818231207966

Truth Clevenger, Jakob Paz, Andrew Stafford, Deborah Amos, A Wallace Hayes

{"title":"An Evaluation of Zebrafish, an Emerging Model Analyzing the Effects of Toxicants on Cognitive and Neuromuscular Function.","authors":"Truth Clevenger, Jakob Paz, Andrew Stafford, Deborah Amos, A Wallace Hayes","doi":"10.1177/10915818231207966","DOIUrl":"10.1177/10915818231207966","url":null,"abstract":"An emerging alternative to conventional animal models in toxicology research is the zebrafish. Their accelerated development, regenerative capacity, transparent physical appearance, ability to be genetically manipulated, and ease of housing and care make them feasible and efficient experimental models. Nonetheless, their most esteemed asset is their 70% (+) genetic similarity with the human genome, which allows the model to be used in a variety of clinically relevant studies. With these attributes, we propose the zebrafish is an excellent model for analyzing cognitive and neuromuscular responses when exposed to toxicants. Neurocognition can be readily analyzed using visual discrimination, memory and learning, and social behavior testing. Neuromuscular function can be analyzed using techniques such as the startle response, assessment of activity level, and evaluation of critical swimming speed. Furthermore, selectively mutated zebrafish is another novel application of this species in behavioral and pharmacological studies, which can be exploited in toxicological studies. There is a critical need in biomedical research to discover ethical and cost-effective methods to develop new products, including drugs. Through mutagenesis, zebrafish models have become key in meeting this need by advancing the field in numerous areas of biomedical research.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71412215","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 Review of Hydrotropic Solubilization Techniques for Enhancing the Bioavailability of Poorly Soluble Drugs. 提高难溶性药物生物利用度的亲水增溶技术研究进展。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-01-01 Epub Date: 2023-11-24 DOI: 10.1177/10915818231216414

Uddeshya Sharma, Kamal Saroha

引用次数: 0

Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine. D-PLEX100在幼年小型猪腹部手术切口模型中的临床前体内安全性和毒代动力学。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-01-01 Epub Date: 2023-10-03 DOI: 10.1177/10915818231205222

Yuval Ramot, Abraham Nyska, Meidan Dvir, Shlomo Nedvetzki, Sefi Rosenfeld, Noam Emanuel

{"title":"Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine.","authors":"Yuval Ramot, Abraham Nyska, Meidan Dvir, Shlomo Nedvetzki, Sefi Rosenfeld, Noam Emanuel","doi":"10.1177/10915818231205222","DOIUrl":"10.1177/10915818231205222","url":null,"abstract":"D-PLEX100 (D-PLEX) is a novel product candidate made of a polymer-lipid-based matrix (PLEX platform) which contains doxycycline that is being released at a constant rate for 30 days. D-PLEX was developed to prevent surgical site infections, which are a major global health challenge. Previous studies have shown its safety in adult humans, adult swine, and adult rabbits. The aim of this study was to assess the toxicity and safety of D-PLEX also in juvenile animals to support future clinical trials in pediatric patients. Yucatan miniature swine were selected as a model, primarily due to their relatively larger mass. D-PLEX or placebo (formulation without doxycycline) was administered locally to abdominal incisions, and the animal's safety parameters were followed for 9 months and compared to sham-control swine. There was no evidence of any systemic safety concern or local toxicity at the incision site in D-PLEX-treated animals. D-PLEX was detected after 1 month and was fully resorbed at the 3-month time point. The surgical incision sites were fully healed at the 6-month time point in all D-PLEX-treated animals. Toxicokinetic (TK) assessments revealed that doxycycline exhibited low Cmax and therefore minimal systemic exposure following a single dose of local administration. This study provides evidence for the safety of D-PLEX and PLEX-based formulation in juvenile miniature swine and supports its further testing in clinical pediatric population. In addition, it can be used as a reference for future preclinical studies aiming to evaluate the safety of other PLEX-based product candidates for the pediatric population.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851645/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41137078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Editor's Note. 编者按

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-01-01 Epub Date: 2023-12-06 DOI: 10.1177/10915818231220244

引用次数: 0