评估酒石酸 XQ528 对 SD 大鼠胚胎-胎儿发育毒性和遗传毒性的影响。

IF 2.1 4区 医学 Q3 CHEMISTRY, MULTIDISCIPLINARY
Drug and Chemical Toxicology Pub Date : 2025-05-01 Epub Date: 2024-08-30 DOI:10.1080/01480545.2024.2389951
Yijun Tian, Wenjing Shi, Bin Zhang, Lijun Ren, Lang Yan, Qiong Xie, Xiao Chen, Tianbao Zhang, Zhuibai Qiu, Yuping Zhu
{"title":"评估酒石酸 XQ528 对 SD 大鼠胚胎-胎儿发育毒性和遗传毒性的影响。","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":null,"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":2.1000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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\":null,\"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\":2.1000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug and Chemical Toxicology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/01480545.2024.2389951\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/30 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug and Chemical Toxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/01480545.2024.2389951","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/30 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
引用次数: 0

摘要

通过胚胎-胎儿发育毒性试验,评估了酒石酸 XQ528 对肥育的斯普拉格-道利(SD)大鼠及其胚胎和同胎仔鼠的胚胎和胎儿发育的影响。肥育的 SD 大鼠在妊娠期第 6 至 15 天分别鼻内注射 0.25、1.25 和 5.0 毫克/千克的剂量时,未表现出明显的一般毒性效应。该化合物的遗传毒性是通过一系列试验进行评估的,包括艾姆斯试验、中国仓鼠卵巢(CHO)细胞染色体畸变试验和 ICR 小鼠微核试验。阿姆斯试验的结果表明,在浓度为 5000、500、50.0、5.0 和 0.5 μg/dish 时,TA97、TA98、TA100、TA102 和 TA1535 菌株均无突变性。此外,浓度为 50.5、101.0 和 202.0 微克/毫升时,CHO 细胞的染色体畸变率没有明显变化。鼻内给药 11.25、22.50 和 45.00 毫克/千克的剂量水平下,ICR 小鼠未观察到微核诱导现象。总之,在本研究的试验条件下,XQ528 酒石酸盐对肥育 SD 大鼠、胚胎和同胎仔鼠的发育毒性的无观测不良效应水平(NOAEL)确定为 5.0 毫克/千克/天。在这些测试条件下,酒石酸 XQ528 没有表现出任何明显的遗传毒性或致癌性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of XQ528 tartrate on embryo-fetus developmental toxicity in SD rats and genotoxicity.

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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Drug and Chemical Toxicology
Drug and Chemical Toxicology 医学-毒理学
CiteScore
6.00
自引率
3.80%
发文量
99
审稿时长
3 months
期刊介绍: Drug and Chemical Toxicology publishes full-length research papers, review articles and short communications that encompass a broad spectrum of toxicological data surrounding risk assessment and harmful exposure. Manuscripts are considered according to their relevance to the journal. Topics include both descriptive and mechanics research that illustrates the risk assessment implications of exposure to toxic agents. Examples of suitable topics include toxicological studies, which are structural examinations on the effects of dose, metabolism, and statistical or mechanism-based approaches to risk assessment. New findings and methods, along with safety evaluations, are also acceptable. Special issues may be reserved to publish symposium summaries, reviews in toxicology, and overviews of the practical interpretation and application of toxicological data.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信