International Journal of Toxicology最新文献_第7页

Toxicological Assessment of Higher Olefins in OECD TG 422 Repeated Dose and Reproductive /Developmental Toxicity Screening Tests in Han Wistar Rats. OECD TG 422重复给药和汉族Wistar大鼠生殖/发育毒性筛选试验中高级烯烃的毒理学评估。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-05-01 Epub Date: 2023-11-07 DOI: 10.1177/10915818231210856

Quan Shi, Juan-Carlos Carrillo, Michael G Penman, Hua Shen, Colin M North, Sophie Jia, Tilly Borsboom-Patel, Yuan Tian, Fabienne Hubert, Jason C Manton, Peter J Boogaard

{"title":"Toxicological Assessment of Higher Olefins in OECD TG 422 Repeated Dose and Reproductive /Developmental Toxicity Screening Tests in Han Wistar Rats.","authors":"Quan Shi, Juan-Carlos Carrillo, Michael G Penman, Hua Shen, Colin M North, Sophie Jia, Tilly Borsboom-Patel, Yuan Tian, Fabienne Hubert, Jason C Manton, Peter J Boogaard","doi":"10.1177/10915818231210856","DOIUrl":"10.1177/10915818231210856","url":null,"abstract":"Higher olefins (HO) are used primarily as intermediates in the production of other chemicals, such as polymers, fatty acids, plasticizer alcohols, surfactants, lubricants, amine oxides, and detergent alcohols. The potential toxicity of five HO (i.e., 1-Octene, Nonene, Decene, Hexadecene, and 1-Octadecene) with carbon ranging from C8 to C18 was examined in a combined repeated dose and reproduction/developmental toxicity screening study (OECD TG 422). These five HO were administered to Han Wistar rats by gavage at 0 (controls), 100, 300, and 1000 mg/kg bw/day. As a group of substances, adaptive changes in the liver (liver weight increase without pathological evidence), as well as increased kidney weight in male rats, were observed in HO with carbon numbers from C8 to C10. The overall systemic no observed adverse effect level (NOAEL) for all HO was determined at 1000 mg/kg bw/day. In the reproductive/developmental toxicity assessment, offspring viability, size, and weights were reduced in litters from females treated with Nonene at 1000 mg/kg bw/day. The overall no observed effects level (NOEL) for reproductive toxicity was considered to be 300 mg/kg bw/day for Nonene and 1000 mg/kg bw/day for the other four HO, respectively. These data significantly enrich the database on the toxicity of linear and branched HO, allowing comparison with similar data published on a range of linear and branched HO. Comparisons between structural class and study outcome provide further supportive data in order to validate the read-across hypothesis as part of an overall holistic testing strategy.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"301-326"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71481530","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

In vitro Safety Assessment of Extracts and Compounds From Plants as Sunscreen Ingredients. 植物提取物和化合物作为防晒成分的体外安全性评估。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-05-01 Epub Date: 2024-01-06 DOI: 10.1177/10915818231225661

Silvia Juliana Flórez González, Elena E Stashenko, Raquel Elvira Ocazionez, María Pilar Vinardell, Jorge Luis Fuentes

{"title":"In vitro Safety Assessment of Extracts and Compounds From Plants as Sunscreen Ingredients.","authors":"Silvia Juliana Flórez González, Elena E Stashenko, Raquel Elvira Ocazionez, María Pilar Vinardell, Jorge Luis Fuentes","doi":"10.1177/10915818231225661","DOIUrl":"10.1177/10915818231225661","url":null,"abstract":"This work investigated the safety of extracts obtained from plants growing in Colombia, which have previously shown UV-filter/antigenotoxic properties. The compounds in plant extracts obtained by the supercritical fluid (CO2) extraction method were identified using gas chromatography coupled to mass spectrometry (GC/MS) analysis. Cytotoxicity measured as cytotoxic concentration 50% (CC50) and genotoxicity of the plant extracts and some compounds were studied in human fibroblasts using the trypan blue exclusion assay and the Comet assay, respectively. The extracts from Pipper eriopodon and Salvia aratocensis species and the compound trans-β-caryophyllene were clearly cytotoxic to human fibroblasts. Conversely, Achyrocline satureioides, Chromolaena pellia, and Lippia origanoides extracts were relatively less cytotoxic with CC50 values of 173, 184, and 89 μg/mL, respectively. The C. pellia and L. origanoides extracts produced some degree of DNA breaks at cytotoxic concentrations. The cytotoxicity of the studied compounds was as follows, with lower CC50 values representing the most cytotoxic compounds: resveratrol (91 μM) > pinocembrin (144 μM) > quercetin (222 μM) > titanium dioxide (704 μM). Quercetin was unique among the compounds assayed in being genotoxic to human fibroblasts. Our work indicates that phytochemicals can be cytotoxic and genotoxic, demonstrating the need to establish safe concentrations of these extracts for their potential use in cosmetics.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"243-252"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139110948","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 Streptococcus salivarius UBSS-01 in Rats and Double-Blind Placebo-Controlled Study in Healthy Individuals 唾液链球菌 UBSS-01 在大鼠中的安全性评估和在健康人中的双盲安慰剂对照研究

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-04-27 DOI: 10.1177/10915818241247527

Bindhu S. Jatoth, Ziaur Rahman, Manoj P. Dandekar, Rajesh Venkataraman, Ravi K. Shivalingegowda, Gloriya G. Manuel

{"title":"Safety Assessment of Streptococcus salivarius UBSS-01 in Rats and Double-Blind Placebo-Controlled Study in Healthy Individuals","authors":"Bindhu S. Jatoth, Ziaur Rahman, Manoj P. Dandekar, Rajesh Venkataraman, Ravi K. Shivalingegowda, Gloriya G. Manuel","doi":"10.1177/10915818241247527","DOIUrl":"https://doi.org/10.1177/10915818241247527","url":null,"abstract":"Streptococcus salivarius is a common, harmless, and prevalent member of the oral microbiota in humans. In the present study, the safety of S. salivarius UBSS-01 was evaluated using in silico methods and preclinical and clinical studies. In an acute toxicity study, rats were administered with 5 g/kg (500 × 109 CFU) S. salivarius UBSS-01. The changes in phenotypic behaviors and hematological, biochemical, electrolytes, and urine analyses were monitored. No toxicity was observed at 14 days post-treatment. The no observable effects limit (NOEL) of S. salivarius UBSS-01 was >5 g/kg in rats. In a 28-day repeat dose toxicity study, rats were administered S. salivarius UBSS-01 once daily at doses of 0.1, 0.5, and 1 g/kg (10, 50, and 100 billion CFU/kg, respectively) body weight. S. salivarius UBSS-01 did not influence any of the hematology parameters and clinical chemistry parameters in plasma and serum samples after 28-day repeated administration. No structural abnormality was observed in the histological examination of organs. Whole genome analysis revealed the absence of virulence factors or genes that may transmit antibiotic resistance. In the double-blind study with 60 human participants (aged 18–60 years), consumption of S. salivarius UBSS-01 for 30 days was found to be safe and results were comparable with placebo treatment These findings indicate that S. salivarius UBSS-01 may be safe for human consumption.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"10 1","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140812420","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

Dose Range-Finding Toxicity Study in Rats With Recombinant Human Lactoferrin Produced in Komagataella phaffii 用 Komagataella phaffii 生产的重组人乳铁蛋白对大鼠进行剂量范围毒性研究

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-04-22 DOI: 10.1177/10915818241247013

Ross Peterson, Robert B. Crawford, Lance K. Blevins, Norbert E. Kaminski, June S. Sass, Bryce Ferraro, Roma Vishwanath-Deutsch, Anthony J. Clark, Carrie-Anne Malinczak

{"title":"Dose Range-Finding Toxicity Study in Rats With Recombinant Human Lactoferrin Produced in Komagataella phaffii","authors":"Ross Peterson, Robert B. Crawford, Lance K. Blevins, Norbert E. Kaminski, June S. Sass, Bryce Ferraro, Roma Vishwanath-Deutsch, Anthony J. Clark, Carrie-Anne Malinczak","doi":"10.1177/10915818241247013","DOIUrl":"https://doi.org/10.1177/10915818241247013","url":null,"abstract":"The oral toxicity of recombinant human lactoferrin (rhLF, Helaina rhLF, Effera™) produced in Komagataella phaffii was investigated in adult Sprague Dawley rats by once daily oral gavage for 14 consecutive days. The study used groups of 3–6 rats/sex/dose. The vehicle control group received sodium citrate buffer, and the test groups received daily doses of 200, 1000, and 2000 mg of rhLF in sodium citrate buffer per kg body weight. Bovine LF at 2000 mg/kg body weight per day was used as a comparative control. Clinical observations, body weight, hematology, clinical chemistry, iron parameters, immunophenotyping, and gross examination at necropsy were used as criteria for detecting the effects of treatment in all groups and to help select dose levels for future toxicology studies. Quantitative LF levels were also analyzed as an indication of bioavailability. Overall, administration of Helaina rhLF by once daily oral gavage for 14 days was well tolerated in rats at levels up to 2000 mg/kg/day, or 57 × Helaina’s intended commercial use in adults, and indicating that a high dose of 2000 mg/kg/day is appropriate for future definitive toxicology studies.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"29 1","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140804396","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

Recovery Animals in Toxicology Studies: An Innovation and Quality Consortium Perspective on Best Practices With Case Study Examples 恢复毒理学研究中的动物：创新与质量联合会的最佳实践视角及案例研究实例

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-04-12 DOI: 10.1177/10915818241243350

Smita Salian-Mehta, James D. Smith, Thierry D. Flandre, Amy L. Lambert, Joan H. Lane, Alan H. Stokes, Kathy Orsted, Natalie A. Bratcher-Petersen, Kyathanahalli S. Janardhan, Elizabeth G. Tonkin

{"title":"Recovery Animals in Toxicology Studies: An Innovation and Quality Consortium Perspective on Best Practices With Case Study Examples","authors":"Smita Salian-Mehta, James D. Smith, Thierry D. Flandre, Amy L. Lambert, Joan H. Lane, Alan H. Stokes, Kathy Orsted, Natalie A. Bratcher-Petersen, Kyathanahalli S. Janardhan, Elizabeth G. Tonkin","doi":"10.1177/10915818241243350","DOIUrl":"https://doi.org/10.1177/10915818241243350","url":null,"abstract":"The inclusion of recovery animals in nonclinical safety studies that support clinical trials is undertaken with a wide diversity of approaches even while operating under harmonized regulatory guidance. While empirical evaluation of reversibility may enhance the overall nonclinical risk assessment, there are often overlooked opportunities to reduce recovery animal use by leveraging robust scientific and regulatory information. In the past, there were several attempts to benchmark recovery practices; however, recommendations have not been consistently applied across the pharmaceutical industry. A working group (WG) sponsored by the 3Rs Translational and Predictive Sciences Leadership Group of the IQ Consortium conducted a survey of current industry practice related to the evaluation of reversibility/recovery in repeat dose toxicity studies. Discussion among the WG representatives included member company strategies and case studies that highlight challenges and opportunities for continuous refinements in the use of recovery animals. The case studies presented in this paper demonstrate increasing alignment with the Society of Toxicologic Pathology recommendations (2013) towards (1) excluding recovery phase cohorts by default (include only when scientifically justified), (2) minimizing the number of recovery groups (e.g., control and one dose level), and (3) excluding controls in the recovery cohort by leveraging external and/or dosing phase data. Recovery group exclusion and decisions regarding the timing of reversibility evaluation may be driven by indication, modality, and/or other scientific or strategic factors using a weight of evidence approach. The results and recommendations discussed present opportunities to further decrease animal use without impacting the quality of human risk assessment.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"1 1","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140577692","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

Editor’s Note 编者按

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-04-04 DOI: 10.1177/10915818241245479

Mary Beth Genter

引用次数: 0

Safety Assessment of Zinc Salts as Used in Cosmetics. 化妆品中使用的锌盐的安全性评估。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-04-01 Epub Date: 2024-01-27 DOI: 10.1177/10915818241227124

Laura N Scott, Monice Fiume, Jinqiu Zhu, 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, Bart Heldreth

引用次数: 0

Safety Assessment of Alkane Diols as Used in Cosmetics. 化妆品中使用的烷二醇安全性评估。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-04-01 Epub Date: 2024-01-04 DOI: 10.1177/10915818231224234

Laura N Scott, Monice 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, Bart Heldreth

引用次数: 0

Mutagenicity Assessment of Homologous Series of Methyl Ester Sulphonates (MES) Using the Bacterial Reverse Mutation (Ames) Test. 利用细菌反向突变(Ames)试验评价甲基酯磺酸盐(MES)同源序列的致突变性。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-03-01 Epub Date: 2023-12-04 DOI: 10.1177/10915818231217041

Yusrabbil Amiyati Yusof, Zafarizal Aldrin Azizul Hasan, Zulina Abd Maurad

{"title":"Mutagenicity Assessment of Homologous Series of Methyl Ester Sulphonates (MES) Using the Bacterial Reverse Mutation (Ames) Test.","authors":"Yusrabbil Amiyati Yusof, Zafarizal Aldrin Azizul Hasan, Zulina Abd Maurad","doi":"10.1177/10915818231217041","DOIUrl":"10.1177/10915818231217041","url":null,"abstract":"Methyl ester sulphonate (MES) is an anionic surfactant that is suitable to be used as an active ingredient in household products. Four palm-based MES compounds with various carbon chains, namely C12, C14, C16 and C16/18 MES, were assayed by the in vitro bacterial reverse mutation (Ames) test in the Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 and the Escherichia coli strain WP2 uvrA, with the aim of establishing the safety data of the compounds, specifically their mutagenicity. The test was also carried out on linear alkylbenzene sulphonate (LAS) for comparison. The plate incorporation method was conducted according to the Organization for Economic Cooperation and Development (OECD) Test Guideline 471. All compounds were tested at five analysable non-cytotoxic concentrations, varying from .001 mg/plate to 5 mg/plate, with and without S-9 metabolic activation. All tested concentrations showed no significant increase in the number of revertant colonies compared to revertant colonies of the negative control. The Ames test indicated that each concentration of C12, C14, C16, C16/18 MES, and LAS used in this study induced neither base-pair substitutions nor frame-shift mutations in the S. typhimurium strains TA98, TA100, TA1535, and TA1537 and the E. coli strain WP2 uvrA. The results showed that C12, C14, C16 and C16/18 MES have no potential mutagenic properties in the presence and absence of S-9 metabolic activation, similarly to LAS. Therefore, the MES is safe to be used as an alternative to petroleum-based surfactants for household cleaning products.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"157-164"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138482318","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

Copper Chaperone Atox1 Protected the Cochlea From Cisplatin by Regulating the Copper Transport Family and Cell Cycle. 铜伴侣阿托x1通过调节铜转运家族和细胞周期保护耳蜗免受顺铂的侵害。

IF 2.2 4区医学

International Journal of Toxicology Pub Date : 2024-03-01 Epub Date: 2023-10-20 DOI: 10.1177/10915818231206665

Xubo Chen, Weiren Xiang, Lihua Li, Kai Xu

{"title":"Copper Chaperone Atox1 Protected the Cochlea From Cisplatin by Regulating the Copper Transport Family and Cell Cycle.","authors":"Xubo Chen, Weiren Xiang, Lihua Li, Kai Xu","doi":"10.1177/10915818231206665","DOIUrl":"10.1177/10915818231206665","url":null,"abstract":"Antioxidant 1 copper chaperone (Atox1) may contribute to preventing DDP cochlear damage by regulating copper transport family and cell cycle proteins. A rat model of cochlear damage was developed by placing gelatin sponges treated with DDP in the cochlea. HEI-OC1 cells were treated with 133 μM DDP as a cell model. DDP-induced ototoxicity in rats was confirmed by immunofluorescence (IF) imaging. The damage of DDP to HEI-OC1 cells was assessed by using CCK-8, TUNEL, and flow cytometry. The relationship between Atox1, a member of the copper transport protein family, and the damage to in vivo/vitro models was explored by qRT-PCR, western blot, CCK-8, TUNEL, and flow cytometry. DDP had toxic and other side effects causing cochlear damage and promoted HEI-OC1 cell apoptosis and cell cycle arrest. The over-expression of Atox1 (oe-Atox1) was accomplished by transfecting lentiviral vectors into in vitro/vivo models. We found that oe-Atox1 increased the levels of Atox1, copper transporter 1 (CTR1), and SOD3 in HEI-OC1 cells and decreased the expression levels of ATPase copper transporting α (ATP7A) and ATPase copper transporting β (ATP7B). In addition, the transfection of oe-Atox1 decreased cell apoptosis rate and the number of G2/M stage cells. Similarly, the expression of myosin VI and phalloidin of cochlea cells in vivo decreased. Atox1 ameliorated DDP-induced damage to HEI-OC1 cells or rats' cochlea by regulating the levels of members of the copper transport family.","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"134-145"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49677417","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