U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of the Commissioner
  5. Office of the Chief Scientist
  6. National Center for Toxicological Research
  7. Science & Research (NCTR)
  8. Xilin Li
  1. Science & Research (NCTR)

Xilin Li Ph.D.

Visiting Scientist — Division of Genetic and Molecular Toxicology

Headshot of Dr. Xilin Li

Xilin (Shawn) Li, Ph.D.
(870) 543-7121
NCTRResearch@fda.hhs.gov  

Back to NCTR Principal Investigators page

About  |  Publications

Background

Dr. Xilin Li received a master’s degree in nutrition science and a doctoral degree in environmental health from Indiana University, where he investigated the mode of action of chemical-induced liver tumor formation and the role of foreign substances in the formation and progression of non-alcoholic fatty liver diseases. After graduation, he joined the Division of Genetic and Molecular Toxicology at FDA’s National Center for Toxicological Research (NCTR), training with Dr. Nan Mei, as an Oak Ridge Institute for Science and Education postdoctoral fellow. In 2021, he continued his research career at NCTR as a visiting scientist. Dr. Li has authored or co-authored over 30 peer-reviewed articles and a book chapter. His work has served as the basis for industry guidance by authorities such as the FDA, Health Canada, and the European Medicines Agency. He has been an active member of professional organizations including the Society of Toxicology, Environmental Mutagenesis and Genomic Society, and Health and Environmental Sciences Institute. He also serves as an editorial board member for multiple scientific journals.

 

Research Interests

Dr. Li's research focuses on utilizing in vivo and in vitro genotoxicity assays and toxicogenomic techniques to provide mechanistic insights for FDA-related chemicals. He has developed a battery of TK6-derived cell lines, each overexpressing a single cytochrome P450 (CYP) human metabolism enzyme through lentivirus-based techniques. This approach, combined with high-throughput genotoxicity assessment tools, enables the detection and screening of compounds for genotoxicity and mutagenicity that require metabolic biotransformation. By identifying specific CYPs responsible for bioactivation, Dr. Li's work contributes crucial mechanistic information. His research extends to evaluating the genotoxicity of various compounds such as pyrrolizidine alkaloids, polyaromatic hydrocarbons, dietary supplements, and drugs using this cell system. This analysis provides valuable insights into the metabolism and hazard identification of these substances. Additionally, Dr. Li's research delves into the mutagenicity of nitrosamine drug substance-related impurities (NDSRIs). This investigation employs in vitro mammalian cell assays—including the micronucleus test, comet assay, thymidine kinase and hypoxanthine-guanine phosphoribosyltransferase gene mutation assays—as supplements to the Ames test, which aid in characterizing the toxicity of structurally diverse NDSRIs lacking carcinogenicity data.

 

Professional Societies/National and International Groups

Carcinogenesis Specialty Section
Secretary/Treasurer
2024 – Present

Environmental Mutagenesis and Genomics Society
Young Investigator Member/Member
2019 – Present

Genotoxicity Risk Assessment and Public Health Special Interest Group
Co-chair 
2023 – Present

Health and Environmental Sciences Institute
Genetic Toxicology Technical Committee 
2023 – Present

Society of Toxicology
Member
2016 – Present

 

Selected Publications

Use of Lentivirus-Based Method for Establishing Human TK6 Cell Lines Expressing Cytochrome P450 and Its Applications in Genotoxicity Testing.
Li X., Chen S., He X., Wu Q., Guo L., and Mei, N.
Curr Protoc. 2024, 4(3):e1003.

Evaluating the Mode of Action of Perfluorooctanoic Acid-Induced Liver Tumors in Male Sprague-Dawley Rats Using a Toxicogenomic Approach. 
Li X., Wang Z, Wu Q., and Klaunig J.E. 
J Environ Sci Health C Toxicol Carcinog. 2024, Online ahead of print.

Evaluation of Weak Genotoxicity of Hydroxychloroquine in Human TK6 Cells.
Li X., Le Y., Chen S., Li Y., Guo L., Fu X., Manjanatha M., and Mei, N.
Toxicol Lett. 2024, 393:84-95.

Toxins in Botanical Drugs and Plant-Derived Food and Feed –from Science to Regulation: A Workshop Review.
Schrenk D., Allemang A., Harms H., Li X., Lin G., Catherine M., Mulder P., Peijnenburg A., Pfuhler S., Punt A., Sievers H., Troutman J., and Widjaja F.
Planta Med. 2024, 90(3):219-242.

The Involvement of Hepatic Cytochrome P450s in the Cytotoxicity of Lapatinib.
Chen S., Li X., Li Y., He X., Bryant M., Qin X., Li F., Seo J.E., Guo X., Mei N., and Guo L.
Toxicol Sci. 2023, 197(1):69-78.

Induction of Apoptosis by Cannabidiol and Its Main Metabolites in Human Leydig Cells.
Li Y., Li X., Cournoyer P., Choudhuri S., Guo L., and Chen S.
Arch Toxicol. 2023, 97(12):3227-3241.

Genotoxicity Assessment of Eight Nitrosamine Impurities Using 2D and 3D HepaRG Cell Models.
Seo J.E., Yu J.Z., Xu H., Li X., Atrakchi A.H., McGovern T., Davis Bruno K.L., Mei N., Heflich R.H., and Guo X.
Arch Toxicol. 2023, 97(10):2785-2798.

Revisiting the Mutagenicity and Genotoxicity of N-Nitroso Propranolol in Bacterial and Human In Vitro Assays.
Li X., Le Y., Seo J.E., Guo X., Li Y., Chen S., Mittelstaedt R.A., Moore N., Guerrero S., Sims A., King S., Atrakchi A.H., McGovern T., Davis Bruno K.L., Keire D., Elespuru R., Heflich R.H., and Mei N.
Regul Toxicol Pharmacol. 2023, 141:105410.

High-Throughput Micronucleus Assay Using Three-Dimensional HepaRG Spheroids for In Vitro Genotoxicity Testing.
Seo J.E., Li X., Le Y., Mei N., Zhou T., and Guo X.
Arch Toxicol. 2023, 97(4):1163-1175.

Cannabidiol-Induced Transcriptomic Changes and Cellular Senescence in Human Sertoli Cells.
Li Y., Li X., Cournoyer P., Choudhuri S., Yu X., Guo L., and Chen S.
Toxicol Sci. 2023, 191(2):227-238.

Genotoxicity Evaluation of Nitrosamine Impurities Using Human TK6 Cells Transduced with Cytochrome P450s.
Li X., He X., Le Y., Guo X., Bryant M.S., Atrakchi A.H., McGovern T., Davis Bruno K.L., Keire D., Heflich R.H., and Mei N.
Arch Toxicol. 2022, 96(11):3077-3089.

In Vitro Effects of Cannabidiol and Its Main Metabolites in Mouse and Human Sertoli Cells.
Li Y., Wu Q., Li X., Von Tungeln L.S., Beland F.A., Petibone D., Guo L., Cournoyer P., Choudhuri S., and Chen S.
Food Chem Toxicol. 2022, 159:112722.

The Genotoxicity Potential of Luteolin is Enhanced by CYP1A1 and CYP1A2 in Human Lymphoblastoid TK6 Cells.
Li X., He X., Chen S., Le Y., Bryant M.S., Guo L., Witt K.L., and Mei N.
Toxicol Lett. 2021, 344:58-68.

Evaluation of Pyrrolizidine Alkaloid-Induced Genotoxicity Using Metabolically Competent TK6 Cell Lines.
Li X., He X., Chen S., Guo X., Bryant M., Guo L., Manjanatha M., Zhou T., Witt K.L., and Mei N.
Food Chem Toxicol. 2020, 145:111662.

Development and Application of TK6-Derived Cells Expressing Human Cytochrome P450s for Genotoxicity Testing.
Li X., Chen S., Guo X., Wu Q., Seo J.E., Guo L., Manjanatha M., Witt K.L., and Mei N.
Toxicol Sci. 2020, 175(2):251-265.

Aristolochic Acid-Induced Genotoxicity and Toxicogenomic Changes in Rodents.
Li X., Guo X., Wang H., Chen T., and Mei N.
World J Tradit Chin Med. 2020, 6(1):12-25.

The Effects of Perfluorooctanoate on High Fat Diet Induced Non-Alcoholic Fatty Liver Disease in Mice.
Li X., Wang Z., and Klaunig J.E.
Toxicology. 2019, 416:1-14.

Modulation of Xenobiotic Nuclear Receptors in High-Fat Diet Induced Non-Alcoholic Fatty Liver Disease.
Li X., Wang Z., and Klaunig J.E.
Toxicology. 2018, 410:199-213.

Contact Information
Xilin Li
(870) 543-7121
Expertise
Expertise
Approach
Domain
Technology & Discipline
Toxicology
Back to Top