About FDA

Biochemical Toxicology

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 centers on quantifying the toxicities and carcinogenic risks associated with 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 assessment studies focused on the understanding of toxicological endpoints, an approach that allows greater confidence in the subsequent risk assessments. Research within the Division capitalizes on scientific knowledge in the areas of biochemistry, organic and analytical chemistry, analytical chemistry, cellular and molecular biology, nutritional biochemistry, toxicology, phototoxicology, computational risk-assessment methods, and pharmacology.

A major emphasis within the Division is to conduct research on compounds nominated by FDA for evaluation by the National Institute of Environmental Health Sciences/National Toxicology Program. This focus reflects NCTR’s superb animal facilities supported by a multidisciplinary staff of scientists with strong mechanistic-research experience, which allows subchronic and chronic toxicological assessments to be conducted in a rigorous manner to address FDA’s needs. These studies currently serve as the benchmark by which toxicological assessments are 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 mechanistic studies to ascertain if the response detected in the experimental model is pertinent to humans.

Ongoing Research Projects
  • 13-Week Dermal Toxicity of Triclosan in B6C3F1 Mice (E0217901)
  • 13-week Range-Finding Phototoxicity Study to Evaluate the Responses of SKH-1 Hairless Mice to Retinyl Palmitate When Incorporated into a Vehicle Cream Containing Butylated Hydroxytoluene (BHT) and Isopropanol (IPA). (E0219301
  • 13-week Studies to Evaluate the Toxicology of Silver Nanoscale Particles (AgNP) in Sprague-Dawley (CD) rats (E0218001)
  • 13-week Study to Determine the Pathogenesis of the Whole Leaf Extract of the Aloe Vera in the Cecum and Large Intestine of the F-344 rat (E0218201)
  • A Toxicological Evaluation of Nanoscale Silver Particles in Rodents (E0217001)
  • An Evaluation of the Effect of Vehicle Cream on the Photococarcinogenicity of Retinyl Palmitate in SKH-1 Mice (E0218501)
  • Animal models of pregnancy to address medical countermeasures for influenza and chemical, biological, radiological and nuclear threats in the "at risk " population of pregnant women.  Phase I. (E0746201)
  • Assessment of molecular changes in male and female Sprague-Dawley rats orally exposed to bisphenol A (BPA) from gestation day 6 through postnatal day 90 (E0218401)
  • Assessment of Nephrotoxicity from a 90-day Combined Exposure to Melamine and Cyanuric Acid in F344 Rats (E0218101)
  • Assessment of Nephrotoxicity from an exposure to melamine, cyanuric acid, and its combination in newborn F344 rats from PND 1 to weaning (E0218901)
  • Biological Based Dose Response (BBDR) Modeling for the Thyroid Axis in the Fetus and Neonate (E0743601)
  • CD-1 mouse diet pilot study - Evaluation of Various Diets on Various Endpoints Criticial to Evaluation of BPA and other Endocrine Active Agents in Mice (E0218301)
  • Clinical and Biological Significance of Three Identified Targets in Systemic Lupus Erythematosus Ptient PBMCs: IL-18, TNFSF13B, and FoxP3 (E0744611)
  • Determination of Cytotoxicity and Genotoxicity of Nanomaterials of Interest to the FDA and Mechanism of Action (E0752701)
  • Developing methods for the evaluation of smokeless tobacco associated carcinogenesis (E0748801)
  • Development and evaluation of a novel in vitro epigenomic screening model system for the hazard identification of FDA-regulated products (E0755001)
  • Development of a targeted microRNA-based epigenetic approach for breast cancer treatment (E0746101)
  • Di(2-ethylexl)phthalate (DEHP) and Bisphenol A (BPA) Exposure in Pediatric Patients (R. Brown, CDRH) (E0742501)
  • Distribution of an adjuvant containing squalene and alpha-tocopherol in mice (E0751401)
  • Effect of Soy-Containing Diets on Ammonium Perchlorate-Induced Thyroid Toxicity in Sprague-Dawley Rats - II (E0742201)
  • Evaluating conventional methods for thermal and chemical inactivation of the bioterrorism agent ricin contaminating pilot-scale milk pasteurization equipment (E0746701)
  • Evaluation of molecular, morphological, and functional endpoints in Sprague-Dawley rats (NCTR) treated with bisphenol A (BPA) [CAS # 80-05-7] administered by gavage toSprague-Dawley rats (NCTR) from gestational day 6 until birth and directly to pups from PND1; continuous and stop dose (PND 21) exposures (E0219101)
  • Evaluation of the Toxicity of Bisphenol (BPA) in Male and Female Sprague-Dawley Rats Exposed Orally from Gestation Day 6 through Postnatal Day 90 - Subchronic II (E0217601)
  • Human Biomonitoring for Bisphenol A (E0743101)
  • Human Biomonitoring for Exposure to Bisphenol A (BPA) and Potential Replacement Products (E0747101)
  • Mechanism of Tumorigenic Pyrrolizidine Alkaloids and Development of LC-ES-MS/MS Methodology for Detection and Quantification of Pyrrolizidine Alkaloids (E0728901)
  • Mechanistic study on the disruption of thyroid hormone homeostasis resulting from sub-chronic dermal exposure of triclosan to mice (E0752901)
  • PBPK Models for Bisphenol A (E0742601)
  • Perinatal Carcinogenicity of Drug Combinations Used to Prevent Mother-to-Child Transmission of HIV (E0214111)
  • Phytoestrogens and Aging: Dose, Timing, and Tissue (E0721001)
  • Population-Based Computational Framework for Assessing Xenobiotic Disposition and Interaction Effects in Pregnant Women Pilot Study (E0752201)
  • Rapid Detection of Ribosome-inactivating protein Toxins in Foods (E0736101)
  • Relationship between Liver Epigenetic Phenotype and Susceptibility to Nonalcoholic Steatohepatitis-Induced Hepatocarcinogenesis in Mice (E0735301)
  • Sex and Ethnic Differences in Expression of Toll-like Receptors (TLR-3, TLR-7, and TRL-9 ) in Systemic Lupus Erythematous (SLE): New Targets for Emerging Therapeutics (E0744601)
  • Sex differences in drug-induced QT prolongation and torsade de pointes: establishing an in vitro model for high-throughput screening and risk assessment of torsadogenicdrugs (E0754001)
  • Sex Differences in Systemic Lupus Erythematosus (SLE):  Effects of a Single Nucleotide Polymorphism (SNP) in the Prolactin (PRL) Gene on Individual Response to Prasterone Therapy (E0727401)
  • Study of Drug-Induced Liver Toxicity using State-of-the-Art In Vitro Liver Models Including Primary Rat and Mouse Hepatocytes and Stem Cells (E0732101)
  • Study of Nanoparticles Migration from Food-Contact Nano-Materials. Characterization and Quantification of Silver Nanoparticles in Stimulants (E0736801)
  • The Role of ABC-Drug Transporters in Chemoresistance in Pancreatic Cancer (E0751101)
  • The role of Sex in Expression of DNA Cytosine 5-Metyltransferases, Histone Deacetylases,  Acetylases, Metyltransferases and Demethylases among Patients with Systemic Lupus Erythematosus (SLE): Elucidating Potential New Drug Targets (E0738601)
  • Two-Year Carcinogenicity Bioassay of Furan in F344 Rats (E0216801)
  • Two year chronic toxicology study of bisphenol A (BPA) [CAS # 80-05-7] administered by gavage to Sprague-Dawley rats (NCTR) from gestational day 6 until birth and directly to pups from PND1; continuous and stop dose (PND 21) exposures (E0219001)
  • Vehicle Selection for Triclosan Dermal Toxicity Studies in B6C3F1 Mice (E0217501)

NCTR's Annual Report contains information on the latest accomplishments and plans for the Division of Biochemical Toxicology as well as project and publication listings.

Contact FDA

National Center for Toxicological Research

Food and Drug Administration

3900 NCTR Road

Jefferson, AR 72079

Page Last Updated: 07/07/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.