Camila Araújo Miranda, João Rodolfo Domingues Mansano, Fábio Erminio Mingatto
{"title":"Ivermectin-induced toxicity in HepG2 cells and the protective effect of tetrahydrocurcumin and vitamin C.","authors":"Camila Araújo Miranda, João Rodolfo Domingues Mansano, Fábio Erminio Mingatto","doi":"10.1080/01480545.2024.2389954","DOIUrl":"10.1080/01480545.2024.2389954","url":null,"abstract":"<p><p>Ivermectin (IVM) is a semi-synthetic antiparasitic derived from abamectin, one of the natural avermectins. The liver promotes metabolism and excretion of IVM, representing a risk of toxicity to this organ. The use of antioxidants to alleviate damage caused by chemicals has been increasingly studied. Thus, the aim of this study was to evaluate the effects of IVM on HepG2 cells to elucidate the mechanisms related to its toxicity and the possible protection provided by tetrahydrocurcumin (THC) and vitamin C. HepG2 cells were treated with IVM (1-25 μM) for 24 and 48 h. IVM was cytotoxic to HepG2 cells, denoted by a dose-dependent decrease in cell proliferation and metabolic activity. In addition, IVM induced damage to the cell membrane at all tested concentrations and for both incubation times. IVM significantly decreased the mitochondrial membrane potential from concentrations of 5 μM (24 h) and 1 μM (48 h). Additionally, IVM showed a time- and dose-dependent decrease in cellular adenosine triphosphate levels. The levels of reduced glutathione were decreased in a time- and dose-dependent manner, while IVM stimulated the production of reactive oxygen and nitrogen species (RONS) at all tested doses, reaching rates above 50% following treatment at 7.5 μM (24 h) or 5 μM (48 h). Treatment with THC (50 μM) and vitamin C (50 μM) protected against IVM-induced cytotoxicity and RONS production. These results suggest that oxidative damage is involved in IVM-induced toxicity in HepG2 cells, and that THC and vitamin C can mitigate the toxic effects caused by the compound.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"595-605"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999598","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}
{"title":"Exploring health beneficial effects of poisonous mushroom <i>Paxillus involutus</i> Batsch Fr.","authors":"Jovana Petrović, Jasmina Glamočlija, Stefana Cvetković, Biljana Nikolić, Uroš Gašić, Dragana Robajac","doi":"10.1080/01480545.2024.2412776","DOIUrl":"10.1080/01480545.2024.2412776","url":null,"abstract":"<p><p>In the present study, phenolic and flavonoid composition and biological properties of methanolic extract of wild growing <i>Paxillus involutus</i> collected in Serbia have been investigated. Ellagic acid was the most abundant phenolic compound (34.92 µg g-<sup>1</sup>), followed by 5-O-caffeoylquinic acid (4.51 µg g-<sup>1</sup>), whereas isoorientin was the most abundant flavonoid (3.42 µg g-<sup>1</sup>). <i>P. involutus</i> turned out to be a rich source of phenolic compounds (74.67 mg GAE g-<sup>1</sup> d.w.), whereas total flavonoid content was significantly lower (4.05 mg QE g-<sup>1</sup> d.w.). As for the various investigated biological activities, methanolic extract exerted high level of antioxidant, antimicrobial and antibiofilm activities. The highest antioxidative potential was measured by TAC (350 TE mg g-<sup>1</sup> d.w.), whereas evaluation of antimicrobial properties showed selective antimicrobial potential toward tested pathogenic microorganisms, with resistant strain of <i>E. coli</i> being the most susceptible to the activity of the extract (MIC 0.08 mg mL-<sup>1</sup>, MBC 0.16 mg mL-<sup>1</sup>). Furthermore, methanolic extract of <i>P. involutus</i> demonstrated genotoxicity, severe hemolysis effects and selective cytotoxicity against colon cancer cells. From the obtained data, it may be concluded that investigated mushroom albeit being toxic for human consumption, may be considered as a source of highly bioactive components with potential application in drug development.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"616-626"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460502","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}
{"title":"Mitigating aluminum chloride-induced toxicity in <i>Drosophila melanogaster</i> with peptide fractions from <i>Euphorbia</i> species.","authors":"Jola-Jesu Mercy Akano, Zainab Abiodun Molik, Amos Olalekan Abolaji, Omonike Oluyemisi Ogbole","doi":"10.1080/01480545.2024.2421916","DOIUrl":"10.1080/01480545.2024.2421916","url":null,"abstract":"<p><p>This study assessed the antioxidative and protective effects of peptide extracts from selected <i>Euphorbia</i> species on Aluminum Chloride (AlCl<sub>3</sub>)-induced toxicity in <i>Drosophila melanogaster. Euphorbia humifusa</i> (EHU), <i>Euphorbia hirta</i> (EHI), and <i>Euphorbia graminae</i> (EHG) were screened for bioactive peptides. The crude peptide extract and partially purified peptide fractions of all the plants were subjected to preliminary antioxidants activities through 2, 2-diphenyl-1-picrylhyhdrazyl (DPPH), and nitric oxide (NO) scavenging activities. The most active peptide fraction was subjected to biochemical studies using <i>Drosophila melanogaster.</i> Flies were treated with AlCl<sub>3</sub> (100 mg/kg diet), peptide fraction (5 and 10 mg/kg diet), and cotreatment of AlCl<sub>3</sub> and the fraction, respectively. After treatment, flies were homogenized for the determination of total thiol and Glutathione (non-protein thiol) content, catalase and Glutathione-S-transferase activities, and nitric oxide (nitrite/nitrate) and hydroperoxide levels. The antioxidant screening revealed that the peptide fraction from <i>Euphorbia humifusa</i> (PEHU) was the most significant compared to the control (ascorbic acid). The PEHU (5 and 10 mg/kg diet) maintained the redox status of the flies in the biochemical study. The PEHU significantly counteracted AlCl<sub>3</sub>-induced reduction in antioxidants (catalase, GST, GSH and Total thiol), increased nitric oxide levels, and acetylcholinesterase activity and prevented behavioral deficits flies. Hence, the peptide fraction of <i>Euphorbia humifusa</i> may shield against the life-threatening effects of free radicals associated with aluminum chloride toxicity.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"687-696"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582191","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}
{"title":"The effect of cut sizes and pH of tobacco leaf in smokeless tobacco products on the pharmacokinetics of nicotine.","authors":"Ya'ning Fu, Hongjuan Wang, Yingyan Li, Pengpeng Yu, Yue Su, Wanwan Ma, Shulei Han, Yushan Tian, Huan Chen, Hongwei Hou","doi":"10.1080/01480545.2024.2431862","DOIUrl":"10.1080/01480545.2024.2431862","url":null,"abstract":"<p><p>The absorption of nicotine from smokeless tobacco products (STPs) in humans is affected by various factors, including nicotine content, flavoring compounds, cutting format, tobacco cut sizes, and pH. In this study, participants were asked to use STP 1 for a specific period, after which the nicotine content was measured before and after use to determine the release rate using the <i>Weibull model</i>. Blood samples were collected from participants after 30 min of using STP 1 to assess nicotine pharmacokinetics. Additionally, guinea pigs were administered four types of STPs with varying pH levels, and tobacco cut sizes, but with identical nicotine content on the oral mucosa to evaluate nicotine pharmacokinetics. The human results showed that nicotine in STP was quickly released in the mouth, reaching 73.66% within 30 min. Plasma nicotine concentration in guinea pigs and human participants were comparable following STP use. Guinea pigs exposed to STPs with smaller tobacco cut sizes or higher pH absorbed more nicotine and metabolized it more slowly. The findings suggest that pH and cut size of STPs are key factors affecting nicotine absorption, while the impact of flavoring agents and other components on nicotine absorption remains to be determined.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"660-667"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750336","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}
Ogechukwu E Ezim, Chisom E Nebeolisa, Ifeoma G Emeagwali-John, Victoria C Obinna, Sunny O Abarikwu
{"title":"Effect of co-administration of gallic acid and quercetin or gallic acid and rutin on impaired spermatogenesis and oxidative damage in a busulfan-treated rat model.","authors":"Ogechukwu E Ezim, Chisom E Nebeolisa, Ifeoma G Emeagwali-John, Victoria C Obinna, Sunny O Abarikwu","doi":"10.1080/01480545.2024.2369591","DOIUrl":"10.1080/01480545.2024.2369591","url":null,"abstract":"<p><p>Gallic acid (GAL), rutin (RUT), and quercetin (QUE) are common antioxidant agents in fruits and vegetables with intriguing pharmacological effects. In the present study, we compared the therapeutic outcomes of GAL + QUE in comparison with GAL + RUT co-treatment in a busulfan (BUS) model of testicular injury in Wistar rats. BUS (4 mg kg<sup>-1</sup> body weight (b.w) was injected intraperitoneally daily for 4 days. GAL + RUT or GAL + QUE (20 mg kg<sup>-1</sup> b. w) was delivered by oral gavage for 52 days. Examination of the testes of BUS-treated rats both biochemically and under light microscopy revealed an increased level of lipid peroxidation, DNA fragmentation, glutathione-<i>S</i>-transferase, lactate dehydrogenase, gamma-glutamyl transpeptidase, alkaline phosphatase and acid phosphatase with a concomitant decrease in the level of antioxidants: glutathione, ascorbic acid, superoxide dismutase, catalase, glutathione peroxidase and glutathione reductase activities, suggesting testicular injury. Tissue sections confirmed the testicular injury-induced by BUS, including diminished spermatogenesis score index, tubular diameter, gonado-somatic index, testis weight, epithelia thickness and higher percentage of aberrant tubules. GAL + QUE co-administration had better recovery effects than GAL + RUT on the biochemical markers and protected against BUS-induced testicular damage. GAL + QUE treatment regimen has better capacity to maintain the antioxidant capacity of the testes and is more potent at reducing BUS-induced oxidative damage compared to GAL + RUT.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"463-476"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141466883","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}
Yijun Tian, Wenjing Shi, Bin Zhang, Lijun Ren, Lang Yan, Qiong Xie, Xiao Chen, Tianbao Zhang, Zhuibai Qiu, Yuping Zhu
{"title":"Evaluation of XQ528 tartrate on embryo-fetus developmental toxicity in SD rats and genotoxicity.","authors":"Yijun Tian, Wenjing Shi, Bin Zhang, Lijun Ren, Lang Yan, Qiong Xie, Xiao Chen, Tianbao Zhang, Zhuibai Qiu, Yuping Zhu","doi":"10.1080/01480545.2024.2389951","DOIUrl":"10.1080/01480545.2024.2389951","url":null,"abstract":"<p><p>The effects of XQ528 tartrate on the embryonic and fetal development of fertile Sprague-Dawley (SD) rats, along with their embryos and littermates, were evaluated using an embryo-fetus developmental toxicity assay. fertile SD rats exhibited no significant general toxic effects when administered doses of 0.25, 1.25, and 5.0 mg/kg intranasally from days 6 to 15 of gestation. The genotoxicity of the compound was evaluated through an amalgam of tests that included the Ames test, the Chinese hamster ovary (CHO) cell chromosome aberration test, and the micronucleus test in ICR mice. The results from the Ames test indicated non-mutagenicity at concentrations of 5000, 500, 50.0, 5.0, and 0.5 μg/dish across strains TA97, TA98, TA100, TA102, and TA1535. Additionally, the chromosomal aberration rates in CHO cells were not significantly altered at concentrations of 50.5, 101.0, and 202.0 μg/mL. No micronuclei induction was observed in ICR mice at dosage levels of 11.25, 22.50, and 45.00 mg/kg post intranasal administration. In conclusion, the no observed adverse effect level (NOAEL) for developmental toxicity of XQ528 tartrate in fertile SD rats, embryos, and littermates under the test conditions in this study was established at 5.0 mg/kg/day. Under these test conditions, XQ528 tartrate did not exhibit any significant genotoxic or carcinogenic potential.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"477-487"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105418","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}
{"title":"Probiotics modulation of the endotoxemic effect on the gut and liver of the lipopolysaccharide challenged mice.","authors":"Gyan Babu, Banalata Mohanty","doi":"10.1080/01480545.2024.2413409","DOIUrl":"10.1080/01480545.2024.2413409","url":null,"abstract":"<p><p>The multistrain probiotics' efficacy in ameliorating the endotoxemic effect in Lipopolysaccharide (LPS) challenged mice was evaluated with the agonist of anti-inflammatory peptide, neurotensin (NTS), especially targeting the inflammation of the gut and liver. Swiss Albino Mice (Female, 8 weeks old) were maintained in eight groups: Group I as Control, Group II-Group V were exposed to intraperitoneal (i.p.) LPS (1 mg/kg bw) for 5 days. After that, Group III and Group VI were administered probiotics orally (0.6 gm/kg bw/day), Group IV and Group VII with NTS receptor 1 (NTSR1) agonist PD149163 (50 µg/kg bw/day i.p.), and Group V and Group VIII co-administered with probiotics and PD149163 for 28 days. Group II (LPS-exposed) was maintained without any further treatment; mice of all the groups were sacrificed at day 34. In the LPS-exposed mice, endotoxemia was distinct from a significant (<i>P</i> < 0.001) increase of plasma pro-inflammatory cytokines (TNF-α; IL-6), a decrease of anti-inflammatory cytokine (IL-10), oxidative stress, and inflammation of the gut and liver. Increased serum transaminases indicated hepatic inflammation. A decreased population of the <i>bifidobacteria</i> and increased <i>clostridia</i> indicated microbiota dysbiosis. Probiotics when used as an adjunct along with PD149163 have shown better efficacy in inflammation modulation as reflected in the significantly decreased (<i>P</i> < 0.001) inflammatory mediators, oxidative stress, restoration of the beneficial bacterial population, along with a significant reduction in histopathological scores of the gut and the liver than when used alone. This study suggests probiotics could be used as an adjunct in clinical practice along with anti-inflammatory drugs for better therapeutic efficacy.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"627-643"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460505","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}
{"title":"Screening and toxicity evaluation of natural compounds as adenosine 2a and 2b receptor ligands: insights from molecular docking, dynamics, and ADMET analysis.","authors":"Fuat Karakuş, Mehmet Abdullah Alagöz, Burak Kuzu","doi":"10.1080/01480545.2024.2389982","DOIUrl":"10.1080/01480545.2024.2389982","url":null,"abstract":"<p><p>Recent studies suggest that immunological and inflammatory responses in cardiovascular disorders, such as hypertension, myocardial infarction, ischemia injury, heart failure, arrhythmias, and atherosclerosis, may be affected by changes in the adenosine system. Pharmacological modulation of adenosine occurs through its receptor subtypes. In numerous preclinical studies, the activation of adenosine receptor 2A (A<sub>2A</sub>R) or the blockade of adenosine receptor 2B (A<sub>2B</sub>R) has shown promising results against cardiovascular diseases. This <i>in silico</i> study aimed to identify potential natural compounds that can activate A<sub>2A</sub>R or block A<sub>2B</sub>R without causing toxicity. Natural compounds were screened using COlleCtion of Open Natural ProdUcTs (COCONUT) or Natural Product Activity and Species Source Database (NPASS) databases to find agonists for A<sub>2A</sub>R or an antagonists/inverse agonists for A<sub>2B</sub>R. These compounds were then pre-filtered based on their toxicity profiles. The remaining compounds were subjected to molecular docking against A<sub>2A</sub>R and A<sub>2B</sub>R followed by molecular dynamics simulations were conducted. Finally, selected compounds' ADMET properties were determined using ADMETlab 2.0 web tool. Ultimately, one novel natural compound with potential agonistic activity (COCONUT IDs: CNP0450901) for A<sub>2A</sub>R and one antagonist/inverse agonist (rauwolscine) for A<sub>2B</sub>R were identified.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"606-615"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008476","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}
Gabriel Osvair Costa Jardim, George Laylson da Silva Oliveira
{"title":"Mancozeb induces cytogenotoxicity in meristematic cells of <i>Allium cepa</i> L.","authors":"Gabriel Osvair Costa Jardim, George Laylson da Silva Oliveira","doi":"10.1080/01480545.2024.2370938","DOIUrl":"10.1080/01480545.2024.2370938","url":null,"abstract":"<p><p>Mancozeb is a fungicide of the dithiocarbamate functional group, and it is widely used in agriculture to control various fungal diseases. Thus, studies detailing its toxicological characteristics are necessary, as the population may be exposed through the consumption of food or water contaminated with mancozeb. The aim of this study was to evaluate the cytotoxic, genotoxic, and mutagenic potentials of this dithiocarbamate using the <i>Allium cepa</i> L. test system as well as its cytotoxicity in erythrocytes of female rats (Rattus norvegicus). The meristematic roots of <i>A. cepa</i> bulbs were exposed to various concentrations of mancozeb (62.5, 125, 250, and 500 mg/L) for 24, 48, and 72 h to determine cytotoxicity by evaluating the mitotic index (MI), chromosomal aberrations (CA), and nuclear anomalies (NA) for genotoxicity analysis and micronuclei (MN) for mutagenicity analysis. Distilled water and copper sulfate (0.0006 mg/L) were used as the negative control (NC) and positive control (PC), respectively. The MI and the sum of CA and NA of all the mancozeb concentrations showed a significant difference (p ≤ 0.05) in relation to the NC, indicating possible cytotoxicity and genotoxicity induced by mancozeb. Additionally, MN significantly increased with mancozeb concentration from 250 mg/L to 500 mg/L in 24 h when compared to NC. In another study model, mancozeb showed to be cytolytic at concentrations starting from 125 mg/L. Therefore, these results indicate that mancozeb causes cytogenetic alterations and mutagenicity at lower concentrations than those used in agriculture, which emphasizes the need for more care when managing this fungicide.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"506-513"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141562948","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}
Sasi Kumar Murugan, Bharathi Bethapudi, Deepak Mundkinajeddu, Prashanth D'Souza
{"title":"Assessment of genotoxicity and acute oral toxicity of a standardized <i>Ocimum tenuiflorum</i> extract (Holixer<sup>TM</sup>).","authors":"Sasi Kumar Murugan, Bharathi Bethapudi, Deepak Mundkinajeddu, Prashanth D'Souza","doi":"10.1080/01480545.2024.2429619","DOIUrl":"10.1080/01480545.2024.2429619","url":null,"abstract":"<p><p><i>Ocimum tenuiflorum</i>, commonly referred to as holy basil or Tulsi, has a long history of use in traditional medicine systems, particularly Ayurveda, due to its various health benefits, including anti-inflammatory, antioxidant, and adaptogenic properties. In contemporary contexts, this plant is progressively incorporated into dietary supplements and nutraceuticals. Given its widespread use and potential health beneficial properties, it is imperative to scientifically evaluate the safety of <i>Ocimum tenuiflorum</i>. This study presents comprehensive safety assessments of a standardized extract of <i>Ocimum tenuiflorum</i>. We conducted a series of genotoxicity studies, including the bacterial reverse mutation test (BRMT), <i>in-vitro</i> mammalian chromosomal aberration (CA) test, and <i>in-vivo</i> mammalian erythrocyte micronucleus (MN) test in Swiss Albino mice. Additionally, an acute oral toxicity study was performed using Sprague Dawley rats, adhering to OECD guidelines in a GLP-compliant laboratory. The results showed no mutagenic effect with <i>O. tenuiflorum</i> extract up to a dose of 5000 µg/plate in BRMT. The results of CA test revealed the non clastogenic activity of <i>O. tenuiflorum</i> extract up to a dose of 500 µg/mL with and without metabolic activation (S9). <i>Ocimum tenuiflorum</i> extract was found to be non-clastogenic at the highest tested dose of 2000 mg/kg bodyweight in <i>invivo</i> MN test. In acute oral toxicity study, <i>O. tenuiflorum</i> extract was found to be safe up to 5 g/kg bodyweight in Wistar rats. Collectively, these findings suggest that <i>Ocimum tenuiflorum</i> extract is non-genotoxic and safe for oral consumption up to 5000 mg/kg body weight in Sprague Dawley rats.</p>","PeriodicalId":11333,"journal":{"name":"Drug and Chemical Toxicology","volume":" ","pages":"530-539"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750330","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}