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  9. Division of Biochemical Toxicology
  1. Science & Research (NCTR)

Division of Biochemical Toxicology Also referred to as: DBT

The Division conducts fundamental and applied research designed specifically to define the biological mechanisms of action underlying the toxicity of products regulated by, or of interest to, the FDA.

Major Functions and Responsibilities

Research is centered on quantifying the toxicities and carcinogenic risks associated with specific chemicals and introducing new risk-assessment techniques to enable regulatory agencies to evaluate the risks associated with exposure to chemicals.


Division Director: Frederick A. Beland, Ph.D.

The Division of Biochemical Toxicology conducts fundamental and applied research specifically designed to define the biological mechanisms of action underlying the toxicity of products regulated by, or of interest to, the Centers of the Food and Drug Administration (FDA). This research is focused on measuring the toxicities and risk of cancer related to specific chemicals and the introduction of new techniques to enable regulatory agencies to evaluate better the risks associated with exposure to chemicals. The risk-assessment research is firmly rooted in mechanistic and exposure studies focused on the understanding of toxicological endpoints. This approach allows greater confidence in the subsequent risk assessments. 

Research Theme

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A major research theme within the Division continues to be toxicological assessments on compounds nominated by the FDA for evaluation by the National Institute of Environmental Health Sciences/National Toxicology Program (NIEHS/NTP). This focus reflects NCTR’s superb animal facilities supported by a multidisciplinary staff of scientists with strong research experience, which allows toxicological assessments to be conducted in a rigorous manner to address FDA’s needs. These studies currently serve as the benchmark for toxicological assessments made by FDA, other federal agencies, and international regulatory bodies. In addition to providing basic information on toxicological endpoints, such as cancer, these experiments form the basis for determining if the response detected in the experimental model is applicable to humans. 


2018 Select Accomplishments

NTP Report on the CLARITY-BPA Core Chronic Study 

A “Draft NTP Research Report on the CLARITY-BPA Core Study: A Perinatal and Chronic Extended-Dose-Range Study of Bisphenol A in Rats” was publicly released by the NTP in February 2018 and was reviewed by an external panel of experts in April 2018. The final, peer-reviewed NTP Research Report was publicly released in September 2018. The NCTR-conducted two-year study was part of an NTP-led effort known as CLARITY-BPA — short for Consortium Linking Academic and Regulatory Insights on BPA Toxicity. As stated in NTP’s Update Newsletter, “NIEHS and FDA convened CLARITY-BPA to study the full range of potential health effects from exposure to BPA in rats and to provide data that could be used for regulatory decisions. CLARITY-BPA united standard research practices used by regulators, called federal guideline studies, with innovative research conducted at universities through grants from NIEHS.” More information about the CLARITY-BPA program can be found at https://ntp.niehs.nih.gov/results/areas/bpa/index.html.

Targeted Therapy for Triple-Negative Breast Cancer (TNBC) 

Division scientists have shown that vorinostat, an FDA-approved histone deacetylase (HDAC) inhibitor, re-expresses estrogen and progesterone receptors, making cancer cells sensitive to targeted drugs like tamoxifen. This finding is important for treating triple-negative breast cancer (TNBC), a highly aggressive type of breast cancer that currently lacks targeted therapies because of its lack of receptors. The five TNBC subtypes, each with a different molecular profile, are known to respond differently to cancer therapies, but HDAC inhibitors are emerging as a possible new therapy. NCTR research, showing that vorinostat controls critical microRNAs (epigenetic targets for drug development) that play important roles in cell proliferation, drug resistance, cell invasion, and metastasis, was presented at the 2018 Annual Meeting of the American Association of Cancer Research. Cell lines from both African Americans and European American women were used in the research study, which was funded by FDA’s Office of Women’s Health. The data from this study contribute to meeting the need for targeted therapies for TNBC. 


2019 Select Research Projects

  • Development of In Vitro Approaches to Assess Drug-Induced Liver Toxicity
  • Characterization of the Relationship Between Liver Epigenomic Phenotype and Susceptibility to Nonalcoholic Steatohepatitis (NASH)
  • Development of an Integrated Network of Physiologically Based Pharmacokinetic (PBPK) Models in Rhesus Monkeys and Humans Across Life-Stages for Predicting Drug Dosimetry in Pregnant Women for the Anti-Influenza Drug Oseltamivir
  • Identification of Mechanistic Biomarkers of Pyrrolizidine Alkaloid-Induced Hepatocarcinogenesis
  • Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Patient Outcomes with Triple-Negative Breast Cancer
  • Evaluation of the Effects of Brominated Vegetable Oil in SD Rats
  • Evaluation of the Effects of the Dietary Supplements Nattokinase and Lumbrokinase in Blood Parameters in SD Rats
  • Evaluation of the Toxicity of High-Molecular-Weight Polyethylene Glycols in SD Rats
  • Tumor Mutational Signatures of Acrylamide and Glycidamide
  • Thermal Inactivation of Staphylococcal Enterotoxins in Milk
  • Percutaneous Absorption of the Sunscreen Component Avobenzone
  • Development of a Multi-Pathway Physiologically Based Pharmacokinetic (PBPK) Model for Nicotine in Humans
  • Animal Models of Pregnancy to Address Medical Countermeasures for Influenza and Chemical, Biological, Radiological, and Nuclear Threats in a "At Risk " Population of Pregnant Women
  • Determination of Cytotoxicity and Genotoxicity of Nanomaterials of Interest to the FDA and Mechanism of Action
  • Role of Epigenetic Mechanisms in Re-Expression of ER, PR, and HER2 in Triple-Negative Breast Cancer: Effects of FDA Approved Epigenetic Drugs, and Dietary Agents and Nicotine

Resources for You




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National Center for Toxicological Research
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(870) 543-7391