Acute, subchronic oral toxicity, toxicokinetics, and genotoxicity studies of DFC-2, an antitubercular drug candidate
- Authors
- Seo, Hoonhee; Al Mahmud, Hafij; Kim, Sukyung; Islam, Md Imtiazul; Lee, Kee-In; Gil, Young Sig; Song, Ho-Yeon
- Issue Date
- Jun-2018
- Publisher
- Academic Press
- Keywords
- DFC-2; M. tuberculosis; Preclinical toxicology; Genotoxicity; Chromosomal aberrations; Reverse mutation test; Micronucleus formation test; Subchronic oral toxicity
- Citation
- Regulatory Toxicology and Pharmacology, v.95, pp 91 - 101
- Pages
- 11
- Journal Title
- Regulatory Toxicology and Pharmacology
- Volume
- 95
- Start Page
- 91
- End Page
- 101
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/5955
- DOI
- 10.1016/j.yrtph.2018.02.011
- ISSN
- 0273-2300
1096-0295
- Abstract
- The infectious disease tuberculosis remains a serious global health issue and is responsible for nearly 1.8 million deaths every year. In our previous study, DFC-2 was confirmed to show anti-tubercular activity against drug-susceptible and drug-resistant strains of Mycobacterium tuberculosis. To support the safety-in-use of DFC-2 as an anti-tubercular drug, DFC-2 was tested via single- and 28-day repeated-dose oral toxicity study and mutagenicity assays. In the oral toxicity study, a single oral dose of DFC-2 at 2000 mg/kg did not produce deaths or abnormal lesions in the internal organs of rats. The results of a 28-day orally repeated dose of DFC-2 did not show treatment-related deaths or obvious toxicity symptoms in the animals treated with a dose of 300 mg/kg/day during the experimental period. Therefore, the no-observed-adverse-effect level (NOAEL) of DFC-2 was determined as 300 mg/kg/day for both male and female rats. In addition, DFC-2 showed no genetic toxicity in in vitro bacterial reverse mutation test, in vitro chromosomal aberration test, and in vivo mouse bone marrow micronucleus formation test. These results indicate that DFC-2 is a promising anti-tubercular drug candidate with a favorable safety profile.
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