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HESI Publications

SELECTED PUBLICATIONS, REPORTS, AND MONOGRAPHS
2006-2007

For a listing of 2006-2007 publications, reports, and monographs, click here.

 

SELECTED PUBLICATIONS, REPORTS, AND MONOGRAPHS
1989-2005

Click on one of the following subject areas to jump directly to that science area:

BIOMONITORING

Doerrer, NG, and Holsapple, MP.  2004.  Integration of biomonitoring exposure data into the risk assessment processRisk Policy Report, Vol. 11, Number 12, pp. 33-35, December 4, 2004.

BIOTECHNOLOGY

Evaluation of Insect Resistance Management in Bt Field Corn; A Science-based Framework for Risk Assessment and Risk Management.  Report of an ILSI Health and Environmental Sciences Institute (HESI) Expert Panel. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1999.

CARCINOGENICITY

Cattley, RC, DeLuca, J, Elcombe, C, Fenner-Crisp, P, Lake, BG, Marsman, DS, Pastoor, TA, Popp, JA, Robinson, DE, Schwetz, B, Tugwood, J, Wahli, W.  Do Peroxisome Proliferating Compounds Pose a Hepatocarcinogenic Hazard to Humans? Regulatory Toxicology and Pharmacology, 126:47–60, 1998.

Cohen, SM, MacDonald J, and Robinson, DE.  Alternative Models for Toxicity Testing.  Toxicologic Sciences, 64: 14-19, 2001.

Counts, JL, McClain, RM, Goodman, JI. Comparison of Effect of Promoter Treatments on DNA Methylation Status and Gene Expression in B6C3F1 Mouse Liver and in B6C3F1 Mouse Liver Tumors.  Molecular Carcinogenesis, 18:97–108, 1997.

Counts, JL, Sarmiento, JI, Harbison, ML, Downing, JC, McClain, RM, Goodman, JI. Cell Proliferation and Global Methylation Status Changes in Mouse Liver after Phenobarbital and/or Choline-devoid, Methionine-deficient Diet Administration.  Carcinogenesis, 17:1251–1257, 1996.

Counts, JL, Goodman, JI.  Hypomethylation of DNA: A Nongenotoxic Mechanism Involved in Tumor Promotion.  Toxicology Letters, 82/83:663–672, 1995.

DeSouza, A, Yamada, T, Mills, J, Jirtle, R. Imprinted Genes in Liver Carcinogenesis.  FASEB Journal, 11:171–174, 1997.

Fifth Workshop on Mouse Liver Tumors.  Report from a workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1994.

First Workshop on Mouse Liver Tumors.  Report from a workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1989.

Fourth Workshop on Mouse Liver Tumors. Report from a workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1992.

Forster, R. A Global Collaboration on Carcinogenicity Screening in Transgenic Mouse Models.  Transgenic Research, 7:485–487, 1999.

Gulezian, D, Jacobson-Kram, D, McCullough, CB, Olson, HM, Recio, L, Robinson, DE, Storer, RD, Tennant RW, Ward JM, Neumann DA. Use of Transgenic Animals for Carcinogenicity Testing: Consideration and Implications for Risk Assessment.  Toxicologic Pathology, 28(3):482–499, 2000.

MacDonald, J, French, JE, Gerson, R, Goodman, J, Inoue, T, Jacobs, A, Kasper, P, Keller, D, Lavin, A, Long, G, McCullough, B, Sistare, F, Storer, R, and van der Laan, JW.  The Utility of Transgenic Assays for Risk Assessment.  Toxicologic Sciences, 77(2): 188-194, 2004.

MacDonald, J, Robinson, DE, and Pettit, S (eds.).  An Evaluation of Alternative Methods for Carcinogenicity Testing.  Toxicologic Pathology, 29: Supplement, 2001.

Mansbach, JM, Mills, JJ, Boyer, IJ, De Souza, AT, Hankins, GR, Jirtle, RL.  Phenobarbital Selectively Promotes Initiated Cells with Reduced TGF  Receptor Levels.  Carcinogenesis, 17(1):171–174, 1995.

Mills, JJ, Jirtle, RL, Boyer, IJ. Mechanisms of Liver Tumor Promotion.  In: Jirtle R, ed. Liver Regeneration and Carcinogenesis.  New York, Academic Press, 199–226, 1995.

Mills, JJ, Chari, RS, Boyer, IJ, Gould, MN, Jirtle, RL. Induction of Apoptosis in Liver Tumors by the Monoterpene Perillyl Alcohol. Cancer Research, 55:979–983, 1995.

Moser, G, Wolf, D, Harden, R, Standeven, A, Mills, J, Jirtle, R. Cell Proliferation and Regulation of Negative Growth Factors in Mouse Liver Foci. Carcinogenesis, 17:1835–1840, 1996.

Ozaki, A, Sagartz, JE, Capen, CC.  Phagocytic Activity of FRTL-5 Rat Thyroid Follicular Cells as Measured by Ingestion of Fluorescent Latex Beads. Experimental Cell Research, 219:547–554, 1995.

Research Update on Peroxisome Proliferation. Report from a workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1994.

Robinson, DE and MacDonald, J.  Background and Framework for ILSI's Collaborative Evaluation Program on Alternative Models for Carcinogenicity Assessment.  Toxicologic Pathology, Supplement, 29:13-19, 2001.

Robinson, DE. The International Life Sciences Institute’s Role in the Evaluation of Alternative Methodologies for the Assessment of Carcinogenic Risk.  Toxicologic Pathology, 26(4):474–475, 1998.

Sagartz, JE, Jhiang, SM, Tong, Q, Capen, CC. Thyroid Stimulating Hormone Promotes Growth of Thyroid Carcinomas in Transgenic Mice with Targeted Expression of ret/PTC1 Oncogene.  Laboratory Investigation, 76:307–318, 1997.

Samiac, PS, Goodman, JI.  Evaluation of Methylated DNA-Binding Protein-1 in Mouse Liver. Toxicological Sciences, 49:255–262, 1999.

Sagartz, JE, Ozaki, A, and Capen, CC.  Phagocytosis of Fluorescent Beads by Rat Thyroid Follicular (FRTL-5) Cells:  Comparison with Iodine Uptake as an Index of Functional Activity of Thyrocytes in vitro. Toxicologic Pathology, 23:635–643, 1995.

Second Workshop on Mouse Liver Tumors. Report from a workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1990.

Sue, S,  Chari, R, Kong, F, Mills, J, Fine, R, Jirtle, R. and Meyers, W. Change in expression of TGF-beta type I, II, and III Receptors and Mannose 6-phosphate/insulin-like Growth Factor II Receptor in Hepatocellular Carcinomas. Ann. Surg., 222:171–178, 1995.

Third Workshop on Mouse Liver Tumors. Report from a workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1991.

DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

An Evaluation and Interpretation of Reproductive Endpoints for Human Health Risk Assessment.  Report from a November 1997 workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1999.

Beckman, DA and Feuston, M.  Landmarks in the Development of the Female Reproductive System.  Birth Defects Research (Part B), 68: 137-143, 2003.

Brent, RL.  Utilization of juvenile animal studies to determine the human effects and risks of environmental toxicants during postnatal developmental stages.  Birth Defects Res., Part B, Dev. Reprod. Toxicol., 71:303-320, 2004. 

Carney, EW, Zablotney, CL, Marty, MS, Crissman, J, Anderson, P, Woolhiser, M, and Holsapple, M.  The effects of feed restriction during in utero and postnatal development in CD rats.  Toxicological Sciences, 82:237-249, 2004.

Holsapple, MP, West, LJ, and Landreth, KS.  Species Comparison of Anatomical and Functional Immune System Development.  Birth Defects Research (Part B), 68: 321-334, 2003.

Hew, KW, and Keller, KA.  Postnatal Anatomical and Functional Development of the Heart: A Species Comparison.  Birth Defects Research (Part B), 68: 309-320, 2003.

Hurtt, ME, Daston, G, Davis-Bruno, K, Feuston, M, Silva Lima, B, Makris, S, McNerney, ME, Sandler, JD, Whitby, K, Wier, P, and Cappon, GD.  Juvenile animal studies: testing strategies and design.  Birth Defects Res., Part B, Dev. Reprod. Toxicol., 71:281-288, 2004. 

Hurtt, ME and Sandler, JD.  Comparative Organ System Development: Introduction.  Birth Defects Research (Part B), 68: 85, 2003.

Hurtt, ME and Sandler, JD.  Comparative Organ System Development: Continuing the Series.  Birth Defects Research (Part B), 68: 307-308, 2003.

Marty, MS, Chapin, RE, Parks, LG, and Thorsrud, BA.  Development and Maturation of the Male Reproductive System.  Birth Defects Research (Part B), 68: 125-136, 2003.

Wathal, K, Cappon, G, Hurtt, M, and Zoetis, T.  Postnatal Development of the Gastrointestinal System: A Species Comparison.  Birth Defects Res., Part B, Dev. Reprod. Toxicol. (in press), 2005.

Wood, SL, Beyer, BK, and Cappon, GD.  Species Comparison of Postnatal CNS Development: Functional Measures.  Birth Defects Research (Part B), 68: 391-407, 2003.

Zoetis, T, Tassinari, MS, Bagi, C, Walthall, K, and Hurtt, ME.  Species Comparison of Postnatal Bone Growth and Development.  Birth Defects Research (Part B), 68: 86-110, 2003.

Zoetis, T and Hurtt, ME.  Species Comparison of Anatomical and Functional Renal Development.  Birth Defects Research (Part B), 68: 111-120, 2003.

Zoetis, T and Hurtt, ME.  Species Comparison of Lung Development.  Birth Defects Research (Part B), 68: 121-124, 2003.

DOSE-DEPENDENT TRANSITIONS

Slikker, W, Jr., Andersen, ME, Bogdanffy, MS, Bus, JS, Cohen, SD, Conolly, RB, David, RM, Doerrer, NG, Dorman, DC, Gaylor, DW, Hattis, D, Rogers, JM, Setzer, RW, Swenberg, JA, and Wallace, K.  Dose-dependent transitions in mechanisms of toxicity.  Toxicol. Appl. Pharmacol., 201:203-225, 2004a.

Slikker, W, Jr., Andersen, ME, Bogdanffy, MS, Bus, JS, Cohen, SD, Conolly, RB, David, RM, Doerrer, NG, Dorman, DC, Gaylor, DW, Hattis, D, Rogers, JM, Setzer, RW, Swenberg, JA, and Wallace, K.  Dose-dependent transitions in mechanisms of toxicity: case studies.  Toxicol. Appl. Pharmacol., 201:226-294, 2004b.

EPIDEMIOLOGY

Collins, JJ, Bukowski, JA, Weed, DL, Brent RL, Bell, DM, Klein, P, Beorstoel-Streefland, M, Sprafka, M, Lavin, AL, Murphy, PA, and Anderson, SA.  Evaluating Emerging Issues in Epidemiology.  Environmental Health Perspectives (submitted), 2005.

EXPOSURE ASSESSMENT

Aggregate Exposure Assessment: Model Evaluation and Refinement Workshop Report.  Report from an October 1999 workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 2000.

GENOMICS

Akerman, GS, Rosenzweib, BA, Domon, OE, McGarrity, LJ, Blankenship, LR, Tsai, CA, Culp, SJ, MacGregor, JT, Sistare, FD, Chen, JJ, and Morris, SM.  Gene expression profiles and genetic damage in benzo(a)pyrene diol epoxide-exposed TK6 cells.  Mutation Research, 549:43-64, 2004.

Amin, RP, Vickers, AE, Sistare, F, Thompson, KL, Roman, RJ, Lawton, M, Kramer, J, Hamadeh, HK, Collins, J, Grissom, S, Bennett, L, Tucker, CJ, Wild, S, Kind, C, Oreffo, V, Davis, II, JW, Curtiss, S, Naciff, JM, Cunningham, M, Tennant, R, Stevens, J, Car, B, Bertram, TA, and Afshari, CA.. Identification of putative gene based markers of renal toxicity. Environmental Health Perspective Toxicogenomics, 112:465-479, 2004. 
 
Baker, VA, Harries, HM, Waring, JF, Duggan, CM, Ni, HA, Jolly, RA, Yoon, LW, De Souza, AT, Schmid, JE, Brown, RH, Ulrich, R, and Gand Rockett, JC. Clofibrate-induced gene expression changes in rat liver: A cross-laboratory analysis using membrane cDNA arrays.  Environmental Health Perspective Toxicogenomics, 112:428-438, 2004.
 
Chu, TM, Deng, S, Wolfinger, R, Paules, RS, and Hamadeh, HK. Cross-site comparison of gene expression data reveals high similarity. Environmental Health Perspective Toxicogenomics, 112:449-455, 2004.
 
Dickinson, DA, Warnes, GR, Quievryn, G, Messer, J, Zhitkovich, A, Rubitski, E, and Aubrecht, J.  Differentiation of DNA reactive and non-reactive genotoxic mechanisms using gene expression profile analysis.  Mutation Research, 549:29-41, 2004.

Goodsaid, FM, Smith, RJ, and Rosenblum, IY.  Quantitative PCR deconstruction of discrepancies between results reported by different hybridization platforms. Environmental Health Perspective Toxicogenomics, 112:456-459, 2004.

Hamadeh, HK, Knight, BL, Haugen, AC, Sieber, S, Amin, RP, Bushel, PR, Stoll, R, Blanchard, K, Jayadev, S, Tennant, RW, Cunningham, ML, Afshari, CA, Paules, RS.  Methapyrilene Toxicity: Anchorage of Pathologic Observations to Gene Expression Alterations. Toxicologic Pathology, Jul-Aug: 30(4)470-82. 2002.

Hu, T, Gibson, DP, Carr, GJ, Torontali, SM, Tiesman, JP, Chaney, JG, and Aardema, MJ.    Identification of a gene expression profile that discriminates indirect-acting genotoxins from direct-acting genotoxins.  Mutation Research, 549:5-27, 2004.

Kramer, JA, Pettit, SD, Amin, RP, Bertram, TA, Car, B, Cunningham, M, Curtiss, SW, Davis, JW, Kind, C, Lawton, M, Naciff, JM, Oreffo, V, Roman, RJ, Sistare, FD, Stevens, J, Thompson, K, Vickers, AE, Wild, S, and Afshari, CA.  Overview on the application of transcription profiling using selected nephrotoxicants for toxicology assessment.  Environmental Health Perspective Toxicogenomics, 112:460-464, 2004.
 
Mattes, WB.  Annotation and cross-indexing of array elements on multiple platforms. Environmental Health Perspective Toxicogenomics, 112:506-510, 2004.
 
Mattes, WB, Pettit, SD, Sansone, SA, Bushel, PR, and Waters, MD.  Database development in toxicogenomics:  Issues and efforts.  Environmental Health Perspective Toxicogenomics, 112:495-505, 2004.
 
Müller, A, Boitier, E, Le Fèvre, AC, Hu, T, Carr, GJ, Marchandeau, JP, Flor, M, Jefferson, F, Aardema, MJ, and Thybaud, T.  Intra- and inter-laboratory variability does not preclude identification of hydroxyurea molecular signature.  Environ. Mol. Mutagen. (in press), 2004.

Newton, RK, Aardema, M and Aubrecht, J.  The utility of DNA microarrays for characterizing genotoxicity.  Environmental Health Perspective Toxicogenomics, 112:420-422, 2004.
 
Pennie, W, Pettit, SD, and Lord, PG.  Toxicogenomics in risk assessment:  An overview of an ILSI Health and Environmental Sciences Institute (HESI) collaborative research program.  Environmental Health Perspective Toxicogenomics, 112:417-419, 2004.
 
Pettit, SD.  Toxicogenomics in risk assessment:  Communicating the challenges.  Environmental Health Perspectives Toxicogenomics, 112(12):A662, 2004.

Robinson, DE, Pettit, SD, Morgan, DG, Use of Genomics in Mechanism Based Risk Assessment. Toxicogenomics.  Inoue, T and Pennie, WD, Eds. Springer-Verlag Tokyo. 2003.

Rosenzweig, BA, Pine, PS, Domon, OE, Morris, SM, Chen, JJ, and Sistare, FD. 2004.  Dye bias correction in dual-labeled cDNA microarray gene expression measurements.  Environmental Health Perspective Toxicogenomics, 112:480-487, 2004.
 
Thompson, KL, Afshari, CA, Amin, RP, Bertram, TA, Car, B, Cunningham, M, Kind, C, Kramer, JA, Lawton, M, Mirsky, M, Naciff, JM, Oreffo, V, Pine, PS, and Sistare, FD.  Identification of platform-independent gene expression markers of cisplatin nephrotoxicity.  Environmental Health Perspective Toxicogenomics, 112:488-494, 2004.
 
Ulrich, RG, Rockett, JC, Gibson, GG and Pettit, SD.  Overview of an inter-laboratory collaboration on evaluating the effects model hepatotoxicants on hepatic gene expression.  Environmental Health Perspective Toxicogenomics, 112:423-427, 2004.
 
Waring, JF, Ulrich, RG, Flint, N, Morfitt, D, Kalkuhl, A, Staedtler, F, Lawton, M, Beekman, JM, and Suter, L.  Interlaboratory evaluation of rat hepatic gene expression changes induced by methapyrilene. Environmental Health Perspective Toxicogenomics, 112:439-448, 2004.

IMMUNOTOXICOLOGY

Chapin, RE. The use of the rat in developmental immunotoxicology studies. Human & Exp. Toxicology, 21:521-524, 2002.

Dayan, AD.  Conclusions and future directions: a personal view from the session chair.  Human & Exp. Toxicology, 21:569-572, 2002.

Dietert, RR, Lee, JE, Bunn, TL.  Developmental immunology: emerging issues.  Human & Exp. Toxicology, 21:479-486, 2002.

Felsburg, PJ.  Overview of immune system development in the dog: comparison with humans. Human & Exp. Toxicology, 21:487-492, 2002.

Hendrickx, AG, Makori, N., Peterson, P.  The non-human primate as a model of developmental immunotoxicology.  Human & Exp. Toxicology, 21:537-542, 2002.

Herzyk, DJ, Bugelski, PJ, Hart, TK., Wier, PJ. Practical aspects of including functional endpoints in developmental toxicity studies.  Case study: immune function in HuCD4 transgenic mice exposed to anti-CD4 MAb in utero. Human & Exp. Toxicology, 21:507-512, 2002.

Holladay, SD, Blaylock, BL.  The mouse as a model for developmental immunotoxicology.  Human & Exp. Toxicology, 21:525-532, 2002.

Holsapple, M, Burns-Naas, LA, Hastings, K, Ladics, GS, Lavin, AL, Makris, S, Yang, Y, and Luster, M.   A proposed testing framework for developmental immunotoxicology (DIT).  Toxicological Sciences, 83(1):18-24, 2005.

Holsapple, MP and Kaminski, NE.  Target organ - Immune system.  In:  Encyclopedia of Toxicology 2nd edition.  Wexler, P, Gad, SC, Tartung, R,  Henderson, RF, Krenzelok,  EP, Mehendale, HM, Plaa, GL,  Wilkinson, C, and Witschi, HP (Eds.).  Academic Press, San Diego, CA. (in press), 2005.

Holsapple, MP, Paustenbach, DJ, Charnley, G, West, LJ, Luster, MI., Dietert, RR, and Burns-Naas, L.  Symposium summary:  Children’s Health Risk – What’s So Special About The Developing Immune System?  Toxicol. Appl. Pharmacol.  199:61-70, 2004.

Holsapple, MP.  Antinuclear antibodies.  In:  Encyclopedic Reference of Immunotoxicology.  H.-W. Vohr, et al. (Eds.).  Springer Press, Heidelberg, Germany (in press), 2004.

Holsapple, MP.  Autoantigens.  In:  Encyclopedic Reference of Immunotoxicology.  H.-W. Vohr, et al. (Eds.).  Springer Press, Heidelberg, Germany (in press), 2004.

Holsapple, MP.  Graft versus host reaction (GVHR).  In:  Encyclopedic Reference of Immunotoxicology.  H.-W. Vohr, et al. (Eds.).  Springer Press, Heidelberg, Germany (in press), 2004.

Holsapple, MP. Developmental Immunitoxicity testing.  A review. Toxicology, 185:193-203, 2003.

Holsapple, MP: Developmental Immunitoxicology and risk assessment: A workshop summary.  Human & Exp. Toxicology, 21:473-478, 2002.

Human and Experimental Toxicology (Vol. 21, Numbers 9-10, September/October 2002).  Journal of Allergy and Clinical Immunology (Vol. 109, Number 3, March 2002).

Immunotoxicology Technical Committee.  Task Force Report:  Future research needs for the prevention and management of immune-mediated drug hypersensitivity reactions.  Journal of Allergy and Clinical Immunology, 109(Vol. 3), s461-478, 2002.

Immunotoxicology Technical Committee.  Application of flow cytometry to immunotoxicity testing:  summary of a workshop.  Toxicology, 163:39-48, 2001.

Immunotoxicity Technical Committee. Application of Flow Cytometry to Immunotoxicology Testing. Report from an October 1997 workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1999.

Immunotoxicology Technical Committee.  Immunotoxicity Testing and Risk Assessment: Summary of a 1994 Workshop. Food Chemical Toxicology, 33(10):887–894, 1995.

Kawabata, TT, Haggerty, HG, Lavin, AL, and Adkinson, NF.  Immune-mediated drug hypersensitivity reactions (IDHR) workshop:  Mechanisms to increase IDHR research opportunities.  J. Immunotoxicol. (in press), 2005.

Landreth, KS. Critical windows in development of the rodent immune system. Human & Exp. Toxicology, 21:493-498, 2002.

Neubert, RT, Webb, JR., Neubert, D.  Feasibility of human trials to developmental immunotoxicology, and some comparison with data on New World monkeys.  Human & Exp. Toxicology, 21:543-568, 2002.

Plitnick, LM, Loveless, SE, Ladics, GS, Holsapple, MP, Smialowicz, RJ, Woolhiser, MR, Anderson, PK, Smith, C, Sailstad, DM, and Selgrade, MJ.  Cytokine mRNA profiles for isocyanates with known and unknown potential to induce respiratory sensitization.  Toxicology (in press), 2005.

Rothkoetter, HJ, Sowa, E., Pabst, R.  The pig as a model of developmental immunotoxicology.  Human & Exp. Toxicology, 21:532, 2002.

Sandler, JD, members of Immunotoxicology Technical Committee.  Executive Summary (Developmental Immunotoxicology and Risk Assessment).  Human & Exp. Toxicology, 21:469-472, 2002.

Smialowicz, RJ. The rat as a model in developmental immunotoxicology. Human & Exp. Toxicology, 21:513-520, 2002.

Weaver, JL,  Chapdelaine, JM,  Descotes, J, Germolec, D., Holsapple, MP, House, R, Lebrec, H, Meade, J. Pieters, R, Hastings, KL, and Dean, JH.  Evaluation of a lymph node proliferation assay for its ability to detect pharmaceuticals with potential to cause immune-mediated drug reactions.  J. Immunotoxicol. (in press), 2005.

West, LJ. Defining critical windows in the development of the human immune system. Human & Exp. Toxicology, 21:499-506, 2002.

White, K. Relevance of Decreased Natural Killer Cell Activity with Altered Host Resistance.  Research report. Washington, DC, ILSI Health and Environmental Sciences Institute (HESI), 1996.

Wilson, SD, McCay, JA, Butterworth, LF, Munson, AE, and White, KL.  Correlation of suppressed natural killer cell activity with altered host resistance models in B6C3F1 mice.  (Supported by the Immunotoxicology Technical Committee).  Toxicology and Applied Pharmacology, 177:208-218, 2001.

Woolhiser, MR, Henry, KS, and Holsapple, MP.   Ecoimmunotoxicology:  State of the science.  In:  Investigative Immunotoxicology.  Tryphonas, H, Fournier, M, Blakely, BR, Smits, JEG, and Brousseau, P (Eds.).  Taylor and Francis.  Pgs. 13-28, 2005.

PROTEIN ALLERGENICITY

Thomas, K, Aalbers, M, Bannon, GA, Bartels, M, Dearman, RJ, Esdaile, DJ, Fu, TJ, Glatt, CM, Hadfield, N, Hatzos, C, Hefle, SL, Heylings, JR, Goodman, RE, Henry, B, Herouet, C, Holsapple, MP, Ladics, GS, Landry, TD, MacIntosh, SC, Rice, EA, Privalle, LS, Steiner, HY, Teshima, R, van Ree, R, Woolhiser, M, and Zawodny, J.  A multi-laboratory evaluation of a common in vitro pepsin digestion assay protocol used in assessing the safety of novel proteins.  Regulatory Toxicology and Pharmacology, 39:87-98, 2004.

TOXICOLOGY AND SAFETY ASSESSMENT

Nussenblatt, RB, Bron, A, Chambers, W, McCulley, JP, Pericoi, M, Ubels, JL, Edelhauser, HF. Ophthalmologic Perspectives on Eye Irritation Testing.  Journal of  Toxicology-Cutaneous & Ocular Toxicology 17(2/3):103–109, 1998.

Olson, H., Betton, G., Robinson, DE, Thomas, K., Monro, A, Kolaja, Lilly, P., Sanders, J., Sipes, G., Bracken, W., Dorato, M., Van Deun, K., Smith, P., Burger, B., and Heller, A.  Concordance of the Toxicity of Pharmaceuticals in Humans and Animals. Regulatory Toxicology and Pharmacology 32: 56-67: 2000.

Olson, H, Betton, G, Stritar, J, and Robinson, DE.  The Predictivity of the Toxicity of Pharmaceuticals in Humans from Animal Data - an Interim Assessment.  Toxicolology Letters 102:535-538, 1999.

Technical Committee on Alternatives to Animal Testing.  Replacing the Draize Eye Irritation Test: Scientific Background and Research Needs.  Journal of Toxicology-Cutaneous & Ocular Toxicology 15(3)211–234, 1996.

WATER QUALITY AND RISK ASSESSMENT

An Evaluation of EPA’s Proposed Guidelines for Carcinogen Risk Assessment Using Chloroform and Dichloroacetate as Case Studies. Report of ILSI Health and Environmental Sciences Institute (HESI) Expert Panel. Washington, D.C., 1997.

Andersen, ME, Boorman, GA, Brusick, DJ, Cohen, SM, Dragan, YP, Frederick, CB, Goodman, JI, Hard, GC, Meek, ME, O’Flaherty, EJ, Robinson, DE.  Lessons Learned Applying the U.S. EPA’s Proposed Cancer Guidelines to Specific Compounds. Toxicological Sciences 53:159–172, 2000.

Andersen, M, Brusick, D, Cohen, S, Dragan, Y, Frederick, C, Goodman, J, Hard, G, Meek, B, O’Flaherty, E. Letters to the Editor. Toxicology and Applied Pharmacology 153:133–134, 1998.

Butterworth, BE, Templin, MV, Constan, AA, Sprankle, CS, Wong, BA, Pluta, LJ, Recio, L. Long Term Mutagenicity Studies with Chloroform and Dimethylnitrosamine in Female Lacl Transgenic B6C3F1 Mice. Environmental and  Molecular Mutagenesis, 31:248–256, 1997.

Craun, GF, Robinson, DE, Hauchman, F (eds.). Microbial Pathogens and Disinfection By-Products in Drinking Water: Health Effects and Management of Risks. ILSI Press, Washington, D.C., 2001.

Craun, GF, Bull, RJ, Clark, RM, Doull, J, Grabow, W, Marsh, GM, Okun, DA, Regli, S, Sobsey, MD, Symons JM  Balancing Chemical and Microbial Risks of Drinking Water Disinfection, Part I, Benefits and Potential Risks.  Journal of Water SRT-Aqua, 43(4):192–199, 1994.

Craun, GF, Regli, S, Clark, RM, Bull, RJ, Doull, J, Grabow, W, Marsh, GM, Okun, DA, Sobsey, MD, Symons, JM.  Balancing Chemical and Microbial Risks of Drinking Water Disinfection, Part II, Managing the Risks.  Journal of Water SRT-Aqua, 43(5):207–218, 1994.

Craun, GF, ed. Safety of Water Disinfection: Balancing Chemical and Microbial Risks. Washington, D.C., ILSI Press, 1993.

Disinfection By-products in Drinking Water: Critical Issues in Health Effects Research. Report from an October 1995 workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1996.

Dourson, ML, Felter, SP, Robinson, DE.  Evolution of Science-based Uncertainty Factors in Noncancer Risk Assessment.  Regulatory Toxicology and Pharmacology, 24:108–120, 1996.

Fawell, J, Robinson, DE, Bull, R, Birnbaum, L, Boorman, G, Butterworth, B, Daniel, P, Galal-Gorchev, H, Hauchman, F, Julkunen, P, Klaassen, C, Krasner, S, Orme-Zavaleta, J, Reif, J, Tardiff, R.  Disinfection By-products in Drinking Water: Critical Issues in Health Effects Research.  Environmental Health Perspectives, 105(1):108–109, 1997.

Golden, RJ, Holm, SE, Robinson, DE, Julkunen, PH, Reese, EA.  Chloroform Mode of Action: Implications for Cancer Risk Assessment.  Regulatory Toxicology and Pharmacology, 26:142–55, 1997.

Hard, G, et al. Re-evaluation of the 2-year Chloroform Drinking Water Carcinogenicity Bioassay Osborne-Mendel Rats Supports Chronic Renal Tubule Injury as the Mode of Action Underlying the Renal Tumor Response. Toxicological Sciences, 53:237–244, 2000.

Identification of New and Uncharacterized Disinfection By-products in Drinking Water. Report from a February 1998 workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1999.

Mechanistic Research Data on Disinfection By-products. Report from an October 1998 workshop. Washington, D.C., ILSI Health and Environmental Sciences Institute (HESI), 1999.

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