Publication Topic

Wikoff D, Fitch S, Borghoff S. Case-study applications using evidence-based approaches to assess endocrine activity for risk assessment. Invited speaker (Wikoff):  61^st Annual Meeting (virtual) of the Society for Birth Defects Research & Prevention, June 2021.

Wikoff D. The [acceptable daily intake] for low- and no-calorie sweeteners: Origin, interpretation, and application. Invited speaker: Continuing education webinar, Institute for the Advancement of Food and Nutrition Sciences, July 2021.

Fitch SE, Payne LE, van de Ligt JLG, Doepker C, Handu D, Cohen SM, Anyangwe N, Wikoff D. 2021. Use of acceptable daily intake (ADI) as a health-based benchmark in nutrition research studies that consider the safety of low-calorie sweeteners (LCS): A systematic map. BMC Public Health 21(1):956, doi: 10.1186/s12889-021-10934-2.

Borghoff SJ, Fitch SE, Black MVB, McMullen PD, Andersen ME, Chappell GA. 2021. A systematic approach to evaluate plausible modes of [action] for mouse lung tumors in mice exposed to 4-methylimidozole. Regul Toxicol Pharmacol 124:104977; DOI: 10.1016/j.yrtph.2021.104977.

Proctor DM, Bhat V, Suh M, Reichert H, Jiang X, Thompson CM. 2021. Inhalation cancer risk assessment for environmental exposure to hexavalent chromium: Comparison of margin-of-exposure and linear extrapolation approaches. Regul Toxicol Pharmacol 124:104969, doi.org/10.1016/j.yrtph.2021.104969.

Saili KS, Antonijevic T, Zurlinden TJ, Shah I, Deisenroth C, Knudsen TB. 2020. Molecular characterization of a toxicological tipping point during human stem cell differentiation. Reprod Toxicol 91:1–13 (selected as journal’s best paper of 2020).

Dirven H, Vist GE, Bandhakavi S, Mehta J, Fitch SE, Pound P, Ram R, Kincaid B, Leenaars CHC, Chen M, Wright RA, Tsaioun K. 2021. Performance of preclinical models in predicting drug-induced liver injury in humans: A systematic review. Nature, Scientific Reports; open access.

Chappell GA, Heintz MM, Borghoff SJ, Doepker CL, Wikoff DS. 2021. Lack of potential carcinogenicity for steviol glycosides — Systematic evaluation and integration of mechanistic data into the totality of evidence. Food Chem Toxicol 150:112045.

Felter SP, Zhang X, Thompson C. 2021. Butylated hydroxyanisole: Carcinogenic food additive to be avoided or harmless antioxidant important to protect food supply? Regul Toxicol Pharmacol 121:104887.

Thompson CM, Gentry R, Fitch S, Lu K, Clewell HJ. 2020. An updated mode of action and human relevance framework evaluation for formaldehyde-related nasal tumors. Crit Rev Toxicol 50(10):919–952, DOI: 10.1080/10408444.2020.1854679.

Gentry R, Thompson CM, Franzen A, Salley J, Albertini R, Lu K, Greene T. 2020. Using mechanistic information to support evidence integration and synthesis: A case study with inhaled formaldehyde and leukemia. Crit Rev Toxicol 50(10):885–918, DOI: 10.1080/10408444.2020.1854678.

Wikoff DS, Urban JD, Ring C, Britt J, Fitch S, Haws LC. 2021. Development of a range of plausible non-cancer toxicity values for 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) based on effects on sperm count: Application of systematic review methods and quantitative integration of dose response using meta-regression. Toxicol Sci 179(2):162-182, https://doi.org/10.1093/toxsci/kfaa171.

Chappell GA, Heintz MM, Haws LC. 2021. Transcriptomic analyses of livers from mice exposed to 1,4-dioxane for up to 90 days to assess potential mode(s) of action underlying liver tumor development. Curr Res Toxicol 2:30–41.

Chappell GA, Wikoff DS, Thompson CM. 2021. Assessment of mechanistic data for hexavalent chromium-induced rodent intestinal cancer using the key characteristics of carcinogens. Toxicol Sci (ms. online ahead of print).

Eichenbaum G, Yang K, Gebremichael Y, Howell BA, Murray FJ, Jacobson-Kram D, Jaeschke H, Kuffner E, Gelotte CK, Lai JCK, Wikoff D, Atillasoy E. 2020. Application of the DILIsym® Quantitative Systems Toxicology drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen. Regul Toxicol Pharmacol 118:104788.

Haws L (session co-chair). Introduction to “Use of New Approach Methods in Risk Characterization of PFAS: Challenges and Opportunities.” 44^th Annual Winter Meeting, the Toxicology Forum, Tysons, VA, Jan 2020 (see: https://dialogue.toxforum.org/d/do/894).

Ring C. Application of high-throughput exposure modeling in risk-based prioritization for PFAS. Presentation at 44^th Annual Winter Meeting, the Toxicology Forum, Tysons, VA, Jan 2020 (see: https://dialogue.toxforum.org/d/do/900).

Antonijevic T, Shah I. Predicting subchronic and chronic animal toxicity from in vitro high content imaging data using PBTK and machine learning. Poster for Society of Toxicology, Virtual Annual Meeting, 2020.

Ring C, Fitch S, Haws L, Harris M, Wikoff D. Quantitative integration of dose-response data for relative potency estimates of dioxin-like chemicals. Poster for Society of Toxicology, Virtual Annual Meeting, 2020.

Suh M, Verwiel A, Proctor D. Oral and inhalation bioaccessibility of cobalt and nickel in metal alloys: A critical consideration for site-specific human health risk assessments and read across. Poster for Society of Toxicology, Virtual Annual Meeting, 2020.

Thompson CM, Ring C, Pham L, Chappell GA, Haws LC. Assessment of the relevance of toxicological findings in the development of an oral reference dose for GenX. Poster for Society of Toxicology, Virtual Annual Meeting, 2020.

Wikoff D, Franzen A, Chappell G, Harris M, Thompson C. Systematic characterization of hexavalent chromium and potential female reproductive outcomes: Application of US EPA critical appraisal tools and stepwise inclusion of mechanistic data. Poster for Society of Toxicology, Virtual Annual Meeting, 2020.

Pham LL, Borghoff SJ, Thompson CM. 2020. Comparison of threshold of toxicological concern (TTC) values to oral reference dose (RfD) values. Regul Toxicol Pharmacol 113:104651 [open access].

Bell S, Mansouri K, Phillips J, Chang X, Abedini J, Karmaus AL, Lea I, Rai R, Allen DG, Casey W, Kleinstreuer NC. NCEATM computational tools and resources supporting alternative test method development and evaluation. Presented at the 59th Annual Meeting of Society of Toxicology, Anaheim CA, March 2020. Abstract #2976-P607.

Lea IA, Jackson MA, Li X, Bailey S, Peddada SD, Dunnick JK. 2007. Genetic pathways and mutation profiles of human cancers: Site- and exposure-specific patterns. Carcinogenesis 28:1851–1858.

Wikoff DS, Bennett DC, Brorby GP, Franke KS. 2020. Evaluation of potential human health risk associated with consumption of edible products from livestock fed ration supplemented with Red Lake Diatomaceous Earth. Food Addit Contam Part A; DOI: 10.1080/19440049.2020.1727963.

Yoon M, Ring C, Van Landingham CB, Suh M, Song G, Antonijevic T, Gentry PR, Taylor MD, Keen AM, Andersen ME, Clewell JH. 2019. Assessing children’s exposure to manganese in drinking water using a PBPK model. Toxicol Appl Pharmacol 380:114695

Wikoff D, Haws L Ring C, Budinsky R. 2019. Application of qualitative and quantitative uncertainty assessment tools in developing ranges of plausible toxicity values for 2,3,7,8‐tetrachlorodibenzo‐p‐dioxin. J Appl Toxicol, doi: 10.1002/jat.3814, open access.

Sheridan E, Moose J, Liu Y, Martini C, Lea I, Fostel J. NTP high-level summary data collections in the Chemical Effects in Biological Systems (CEBS) database. Presented at the 15th International Congress of Toxicology, Honolulu, HI, July 2019. Poster PS01-0606.

Bhawana B, Lea I, Liu Y, Martini C, Fostel J. Access to National Toxicology Program histopathology lesion collection in Chemical Effects in Biological Systems (CEBS) database. Presented at the 38th Annual Symposium of Society for Toxicologic Pathology, Raleigh, NC, June 2019. Poster P040.

Lea I, Liu Y, Sheridan E, Motti D, Martini C, Fostel J, Auerbach S. Hallmark gene set annotation for NTP toxicogenomic studies. Presented at the 58th Annual Meeting of Society of Toxicology, Baltimore, MD, March 2019. Abstract #1743-P119.

Martini C, Liu Y, Motti D, Johnson J, McCormick K, Lea I, Fostel F. Integrating assay datasets into Chemical Effects in Biological Systems (CEBS). Presented at the 58th Annual Meeting of Society of Toxicology, Baltimore, MD, March 2019. Abstract #1749-P125.

Kimzey AL, Piche M-S, Wood M, Weir AB, Lansita J. 2018. 11.19 – Immunophenotyping in drug development. In: Comprehensive Toxicology, 3^rd Ed. Vol 11:399–427.

Tsaioun K, Dirven H, Beck Færden K, Wikoff D, Ram R, Kleinstreuer N, McCormack A, Wright R, Vist GE, Fitch S. 2018. Systematic reviews of the hepatotoxic effects of specified compounds/drugs as observed in humans and experimental animals (rats, mice, dogs and non-human primates). PROSPERO CRD42018112353.

Borghoff SJ, Fitch S, Rager JE, Huggett D. 2018. A hypothesis-driven weight-of-evidence analysis to evaluate potential endocrine activity of perfluorohexanoic acid. Regul Toxicol Pharmacol 99:168–181.

Borghoff S, Wikoff D, Urban JD, Rager JE. A systematic approach to identify plausible mode-of-actions (MOA) for an increased incidence of lung tumors in mice with chronic exposure to 4-methylimidazole (4-MEI). Society of Toxicology Annual Meeting. March 11–15, 2018. San Antonio, TX.

Wikoff DS, Miller GW. 2018. Systematic reviews in toxicology (Editorial). Toxicol Sci 163(2):335–337.

Thompson CT, Suh M, Chappell G, Borghoff S, Ellis-Hutchings, R, Wiench, K, Finch, L, Proctor, DM. 2018. Assessment of the mode of action underlying development of forestomach tumors in rodents following oral exposure to ethyl acrylate and relevance to humans. Regul Toxicol Pharmacol 96:178–189 doi: 10.1016/j.yrtph.2018.05.006.

Suh M, Proctor DM, Chappell G, Rager JE, Thompson CM, Borghoff S, Finch L, Ellis-Hutchings R, Wiench K. 2018. A review of the genotoxic, mutagenic, and carcinogenic potentials of several lower acrylates. Toxicology 402-403:50-67, doi: 10.1016/j.tox.2018.04.006.

Proctor DM, Suh M, Chappell G, Borghoff SJ, Thompson CM, Wiench K, Finch L, Ellis-Hutchings R. 2018. An adverse outcome pathway (AOP) for forestomach tumors induced by non-genotoxic initiating events. Regul Toxicol Pharmacol, 96:30-40, doi: 10.1016/j.yrtph.2018.04.016.

Sheridan ER, Jackson M, Paleja A, Martini C, Rashid A, Lea I, Fostel J. Improved searching in the Chemical Effects in Biological Systems (CEBS) database leads to greater utility of NTP data. Presented at the 57th Annual Meeting of Society of Toxicology, San Antonio, TX, March 2018. Abstract 2525-P887.

Lea IA, Borghoff S, Travlos GS. 2018. Electrolytes, blood gases and acid-base balance. In: Kurtz DM, Travlos GS (eds): The Clinical Chemistry of Laboratory Animals (3rd edition). CRC Press, Boca Raton, FL (https://doi.org/10.1201/9781315155807).

Brorby GP. 2018. The ongoing controversy surrounding the effects of short-term exposure to trichloroethene. Presented at the Association for Environmental Health and Sciences Foundation Annual International Conference, March 19–22, San Diego, CA.

Wikoff D, Urban JD, Harvey S, Haws LC. 2018. Role of risk of bias in systematic review for chemical risk assessment: A case study in understanding the relationship between congenital heart defects and exposures to trichloroethylene. Int J Toxicol, DOI: 0.1177/1091581818754330.

Rager JE, Auerbach SS, Chappell GA, Martin E, Thompson C, Fry RC. 2017. Benchmark dose modeling estimates of the concentrations of inorganic arsenic that induce changes to the neonatal transcriptome, proteome, and epigenome in a pregnancy cohort. Chem Res Toxicol 30(10):1911-1920; DOI: 10.1021/acs.chemrestox.7b00221.

Bichteler A, Wikoff DS, Loko F, Harris MA. 2017. Estimating serum concentrations of dioxin-like compounds in the U.S. population effective 2005-2006 and 2007-2008: A multiple imputation and trending approach incorporating NHANES pooled sample data. Environ Int 105(2017):112-125.

Lea I, Yang L, Rashid A, Fostel JM. Chemical Effects in Biological Systems (CEBS) Database: Treatment-related findings. Presented at the 56th Annual Meeting of Society of Toxicology, Baltimore, MD, March 2017. Abstract 2918-P412.

Martini C, Rashid A, Paleja A, Lea I, Fostel JM. Chemical Effects in Biological Systems (CEBS) database: Treatment-related findings. Presented at the 56th Annual Meeting of Society of Toxicology, Baltimore, MD, March 2017. Abstract 1381-P119.

Sheridan E, Martini C, Shaw M, Shockley K, Brix A, Rashid A, Lea I, Fostel J. Using the Chemical Effects in Biological Systems (CEBS) database to answer pathology questions. Presented at the 36th Annual Symposium of Society for Toxicologic Pathology, Montreal, Quebec, Canada, June 2017. Poster P035.

Jackson M, Yang L, Yauk CL, Lea I, Kuo B, Williams A, Rashid A, Fostel J. The TGx-28.65 biomarker — A web-based application using transcriptomics to identify DNA damage-inducing chemicals. Presented at the 48th Annual Meeting of Environmental Mutagenesis and Genomics Society, Raleigh, NC, September 2017. Abstract 1224.

Kirman CR, Suh M, Proctor DM, Hays SM. 2017. Improved physiologically based pharmacokinetic model for oral exposures to chromium in mice, rats, and humans to address temporal variation and sensitive populations. Toxicol Appl Pharmacol 325:9-17.

Wikoff DS, Rager J, Harvey S, Haws L, Chappell G, Borghoff S. 2017. Framework for quantitative consideration of study quality and relevance in the systematic evaluation of mechanistic data per the Ten Key Characteristics of Carcinogens. Poster presented at Society of Toxicology Annual Meeting, March 15, Baltimore, MD.

Lea IA, Gong H, Paleja A, Rashid, A, Foster J. 2017. CEBS: A comprehensive annotated database of toxicological data. Nucleic Acids Res 45(D1):D964–D971.

Jackson MA, Yang L, Lea I, Rashid A, Kuo B, Williams A, Lyn Yauk C, Fostel J. 2017. The TGx-28 65 biomarker online application for analysis of transcriptomics data to identify DNA damage-inducing chemicals in human cell cultures. Environ Mol Mutagen 58(7):529–535.

Thompson CM, Wolf, JC, McCoy A, Suh M, Proctor DM, Kirman CR, Haws LC, Harris MA. 2017. Comparison of toxicity and recovery in the duodenum of B6C3F1 mice following treatment with intestinal carcinogens captan, folpet, and hexavalent chromium. Toxicol Pathol 45(8):1091–1101. DOI: 10.1177/019262331yy4324.

Borghoff SJ, Ring C, Banton M, Leavens TL. 2016. Physiologically based pharmacokinetic model for ethyl tertiary-butyl ether and tertiary-butyl alcohol in rats: Contribution of binding to a2u-globulin in male rats and high-exposure nonlinear kinetics to toxicity and cancer outcomes.  J Appl Toxicol, DOI 10.1002/jat.3412

Wikoff DS, Britt JK.  2016. The role of systematic review in the practice of toxicology and risk assessment – An appreciation for the primary tool in evidence-based approaches.  Toxicology: Open Access 2(110):1-4. 

Schmitt D, Levy R, Carroll B. 2016. Toxicological evaluation of ß-caryophyllene oil: Subchronic toxicity in rats. Int J Toxicol 35(5):558–567.

Lea I, Rashid A, Favaro C, Fostel J. Chemical Effects in Biological Systems (CEBS) database: Advanced histopathology search applications. Presented at the 54th Annual Meeting of Society of Toxicology, San Diego, CA, March 2015. Abstract 2195-P410.

Ramani T, Auletta CS, Weinstock D, Mounho-Zamora B, Ryan PC, Salcedo TW, Bannish G. 2015. Cytokines: The good, the bad, and the deadly. Int J Toxicol 34(4):355–365, DOI 10.1177/1091581815584918.

Wikoff D, Thompson C, Perry C, White M, Borghoff S, Fitzgerald L, Haws LC. 2014. Development of toxicity values and exposure estimates for tetrabromobisphenol A [TBBPA]: Application in a margin of exposure assessment. J Appl Toxicol 35(11):1292-1308. doi: 10.1002/jat.3132.

Kirman CR, Proctor D, Suh M, Thompson CM, Harris MA, Haws LC, Hays SM. 2014. Variation analysis of PBPK model parameters for describing the delivery of Cr(VI) to the small intestines of humans. Presented at the Society of Toxicology’s 53rd Annual Meeting, March 23-27, Phoenix, AZ.

Johnson GE, Soeteman-Hernandez, Gollapudi BB, Bodger OG, Dearfield KL, RH Heflich, Hixon JG, Lovell DP, MacGregor JT, Pottenger LH, Thompson CM, Abraham L, Thybaud V, Tanir JY, Zeiger E, van Benthem J, White PA. 2014. Derivation of point of departure (PoD) estimates in genetic toxicology studies and their potential applications in risk assessment. Environ Molec Mutagen 55(8):609-623. doi: 10.1002/em.21870/em.21870.

Faber W, Kirkpatrick D, Coder P, Li P, Borghoff S, Banton M. 2014. Subchronic, reproductive, and maternal toxicity studies with tertiary butyl acetate (TBAC). Regul Toxicol Pharmacol 68:332-342.

Song G, Darr DB, Santos CM, Ross M, Valdivia A, Jordan JL, Midkiff BR, Cohen S, Feinberg NN, Miller CR, Tarrant TK, Rogers AB, Dudley AC, Perou CM, Zamboni WC. 2014. Effects of tumor microenvironment heterogeneity on nanoparticle disposition and efficacy in breast cancer tumor models. Clin Cancer Res 20(23):6083–6095.

Bhusari S, Malarkey DE, Hong HH, Wang Y, Masinde T, Nolan M, Hooth NJ, Lea IA, Vasconcelos D, Sills RC, Hoenerhoff MJ. 2014. Mutation spectra of Kras and Tp53 in urethral and lung neoplasms in B6C3F1 mice treated with 3,3′,4,4′-tetrachloroazobenzene. Toxicol Pathol 42(3):555–564.

Suh M, Troese MJ, Hall DA, Yasso B, Yzenas JJ, Proctor DM. 2014. Evaluation of electric arc furnace-processed steel slag for dermal corrosion, irritation, and sensitization from dermal contact. J Appl Toxicol 34(12):1418-1425. DOI: 10.1002/jat.2974.

Henderson RG, Durando J, Oller A, Merkel DJ, Marone PA,  Bates HK. 2012. Acute oral toxicity of nickel compounds. Regul Toxicol Pharmacol 62(3):425-432.

Waters MD, Jackson MA, Lea IA. 2010. Characterizing and predicting carcinogenicity and mode-of-action using conventional and toxicogenomics methods. Mutat Res 705(3):184–200.

Lea IA, Jackson MA, Dunnick JK. 2009. Genetic pathways to colorectal cancer. Mutat Res 670(1–2):96–98.

Jackson MA, Lea I, Rashid A, Peddada SD, Dunnick JK. 2006. Genetic alterations in cancer knowledge system: Analysis of gene mutations in mouse and human liver and lung tumors. Toxicol Sci 90:400–418.

Lea IA, Widgren EE, O’Rand MG. 2004. Association of sperm protein 17 with A-kinase anchoring protein 3 in flagella. Reprod Biol Endocrinol 2:57.

Lea IA, Widgren EE, O’Rand MG. 2002. Analysis of recombinant mouse zona pellucida protein 2 (ZP2) constructs for immunocontraception. Vaccine 20(11–12):1515–1523

Lea IA, Sivashanmugam P, O’Rand MG. 2001. Zonadhesin: Characterization, localization, and zona pellucida binding. Biol Reprod 65(6):1691–700.

Lea IA, Kurth B, O’Rand MG. 1998. Immune response to immunization with sperm antigens in the macaque oviduct. Biol Reprod 58(3):794–800.

Lea IA, Adoyo P, O’Rand MG. 1997. Autoimmunogenicity of the human sperm protein Sp17 in vasectomized men and identification of linear B cell epitopes. Fertil Steril 67(2):355–361.

O’Rand MG, Lea IA. 1997. Designing an effective immunocontraceptive. J Reprod Immunol 36(1–2):51–59; Review.

Adoyo PA, Lea IA, Richardson RT, Widgren EE, O’Rand MG. 1997. Sequence and characterization of the sperm protein Sp17 from the baboon. Mol Reprod Dev 47(1):66–71.

Lea IA, Richardson RT, Widgren EE, O’Rand MG. 1996. Cloning and sequencing of cDNAs encoding the human sperm protein, Sp17. Biochim Biophys Acta 1307(3):263–266.

Lea I, Moore HD, Latchman DS. 1991. Differential expression of the mouse U1a and U1b SnRNA genes is not dependent on sequence differences in the octamer motif. Biochem J 277( Pt 3):719–722.