Select Publications on Methods to Replace and Reduce Animal Use - PETA International Science Consortium, Ltd.

The following papers have been published without Consortium involvement. Publications authored by the Consortium and its members can be found here.

Acute Systemic Toxicity Testing

Corvaro M, Gehen S, Andrews K, Chatfield R, Arasti C, Mehta J. GHS additivity formula: a true replacement method for acute systemic toxicity testing of agrochemical formulations. Regul Toxicol and Pharmacol. 2016;82:99-110.
Moore NP, Andrew DJ, Bjerke DL, Creton S, Dreher D, Holmes T, Prieto P, Seidle T, Rowan TG. Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the globally harmonized system of classification and labeling of chemicals (GHS). Regul Toxicol Pharmacol. 2013;66(1):30-37.
Stoick K, Nitschke K, Sandusky C. Systemic testing by the dermal route can be precluded by new non-animal percutaneous absorption strategies. AATEX. 2007;14:561-564.

Adverse Outcome Pathways

Burden N, Sewell F, Andersen ME, Boobis A, Chipman JK, Cronin MTD, Hutchinson TH, Kimber I, Whelan M. Adverse outcome pathways can drive non-animal approaches for safety assessment. J Appl Toxicol. 2015;35:971-975.
Kleinstreuer NC, Sullivan K, Allen D, Edwards S, Mendrick DL, Embry M, Matheson J, Rowlands JC, Munn S, Maull E, Casey W. Adverse outcome pathways: from research to regulation scientific workshop report. Regul Toxicol and Pharmacol. 2016;76:39-50.
Langley G, Austin CP, Balapure AK, L.S. Birnbaum LS, Bucher JR, Fentem J, Fitzpatrick SC, Fowle JR, Kavlock RJ, Kitano H, Lidbury BA, Muotri AR, Peng SQ, Sakharov D, Seidle T, Trez T, Tonevitsky A, van de Stolpe A, Whelan M, Willett C. Lessons from toxicology: developing a 21st-century paradigm for medical research. Environmental Health Perspectives. 2015;123(11):A268-A272.
Tollefsen KE, Scholz S, Cronin MT, Edwards SW, de Knecht J, Crofton K, Garcia-Reyero N, Hartung T, Worth A, Patlewicz G. Applying adverse outcome pathways (AOPs) to support integrated approaches to testing and assessment (IATA). Regul Toxicol and Pharmacol. 2014;70(3):629-640.
Wittwehr C, Aladjov H, Ankley G, Byrne H, de Knecht J, Heinzle E, Klambauer G, Landesmann B, Luijten M, MacKay C, Maxwell G, Meek ME, Paini A, Perkins E, Sobanski T, Villeneuve D, Waters K, Whelan M. How adverse outcome pathways can aid the development and use of computational prediction models for regulatory toxicology. Tox Sci. 2017;155(2):326-336.

Antibodies and Antitoxins

Unkauf T, Miethe S, Fühner V, Schirrmann T, Frenzel A, Hust M. Generation of recombinant antibodies against toxins and viruses by phage display for diagnostics and therapy. Adv Exp Med Biol. 2016;917:55-76.
Frenzel A, Schirrmann T, Hust M. Phage display-derived human antibodies in clinical development and therapy. mAbs. 2016;8:1177-1194.
Gray A, Sidhu S, Chandrasekera P, Hendriksen C, Borrebaeck C. Animal-friendly affinity reagents: replacing the needless in the haystack. Trends Biotechnol. 2016;34(12):960-969.
Both L, White J, Mandal S, Efstratiou A. Access to diphtheria antitoxin for therapy and diagnostics. Euro Surveill. 2014;19(24):1-6.
Both L, Banyard A, van Dolleweerd C, Wright E, Ma J, Fooks A. Monoclonal antibodies for prophylactic and therapeutic use against viral infections . Vaccine. 2013;31(12):1553-1559.
Bradbury A, Sidhu S, Dübel S, McCafferty J. Beyond natural antibodies: the power of in vitro display technologies. Nature Biotechnology. 2011;29:245-254.

Biologics and Biological Assays

De Mattia F, Hendriksen C, Buchheit KH, Chapsal JM, Halder M, Lambrigts D, Redhead K, Rommel E, Scharton-Kersten T, Sesardic T, Viviani L, Ragan I. The vaccines consistency approach project: an EPAA initiative. Pharmeur Bio Sci Notes. 2015;2015:30-56.
Simon S, Fiebig U, Liu Y, Tierney R, Dano J, Worbs S, Endermann T, Nevers MC, Volland H, Sesardic D, Dorner MB. Recommended immunological strategies to screen for botulinum neurotoxin-containing samples. Toxins (Basel). 2015;7(12):5011-5034.
Dunning FM, Piazza TM, Zeytin FN, Tucker WC. Isolation and quantification of botulinum neurotoxin from complex matrices using the BoTest matrix assays. J Vis Exp. 2014;85:e51170.
Fernández-Salas E, Wang J, Molina Y, Nelson JB, Jacky BP, Aoki KR. Botulinum neurotoxin serotype A specific cell-based potency assay to replace the mouse bioassay. PLoS One. 2012;7(11):e49516.
Sesardic T. Bioassays for evaluation of medical products derived from bacterial toxins. Curr Opin Microbiol. 2012;15(3):310-316.

Computer Modeling

Stanton K, Kruszewski F. Quantifying the benefits of using read-across and in silico techniques to fulfill hazard data requirements for chemical categories. Regul Toxicol and Pharmacol. 2016;81:250-259.
Schultz TW, Amcoff P, Berggren E, Gautier F, Klaric M, Knight DJ, Mahony C, Schwarz M, White A, Cronin MTD. A strategy for structuring and reporting a read-across prediction of toxicity. Regul Toxicol and Pharmacol. 2015;72(3):586-601.

Ecotoxicological Testing

Lillicrap A, Belanger S, Du Pasqiuer D, Embry MR, Halder M, Lampi MA, Lee L, Norberg-King T, Rattner BA, Schirmer K, Thomas P. Alternative approaches to vertebrate ecotoxicity tests in the 21^st century: a review of developments over the last 2 decades and current status. Environ Toxicol Chem. 2016;35(11):2637-2646.
Burden N, Maynard SK, Weltje L, Wheeler JR. The utility of QSARs in predicting acute fish toxicity of pesticide metabolites: A retrospective validation approach. Regul Toxicol Pharmacol. 2016;80:241-246.
Belanger SE, Sanderson H, Embry MR, Coady K, DeZwart D, Farr BA, Gutsell S, Halder M, Sternberg R, Wilson P. It is time to develop ecological thresholds of toxicological concern to assist environmental hazard assessment. Environ Toxicol Chem. 2015;32(12):2864-2869.
Stadnicka-Michalak J, Schirmer K, Ashauer R. Toxicology across scales: Cell population growth in vitro predicts reduced fish growth. Sci Adv. 2015;1(7):e1500302.
Stadnicka-Michalak J, Tanneberger K, Schirmer K, Ashauer R. Measured and modeled toxicokinetics in cultured fish cells and application to in vitro-in vivo toxicity extrapolation. PLOS One. 2014;9(3):e92303.
Belanger SE, Rawlings JM, Carr GJ. Use of fish embryo toxicity tests for the prediction of acute fish toxicity to chemicals. Environ Toxicol Chem. 2013;32(8), 1768-1783.
Tanneberger K, Knöbel M, Bussert FJM, Sinnige TL, Hermens JLM, Schirmer K. Predicting fish acute toxicity using a fish gill cell line-based toxicity assay. Environ Sci Technol. 2013;1110-1119.
Baron MG, Purcell WM, Jackson SK, Owen SF, Jha AN. Towards a more representative in vitro method for fish ecotoxicology: morphological and biochemical characterisation of three-dimensional spheroidal hepatocytes. Ecotoxicology. 2012;2419-2429.

Endocrine Disruptor Screening Program

Kleinstreuer NC, Ceger P, Watt ED, Martin M, Houck K, Browne P, Thomas RS, Casey WM, Dix DJ, Allen D, Sakamuru S, Xia M, Huang R, Judson R. Development and validation of a computational model for androgen receptor activity. Chem Res Toxicol. 2016.

Eye Irritation/Corrosion Testing

Lotz C, Schmid FF, Rossi A, Kurdyn S, Kampik D, De Wever B, Walles H, Groeber FK. Alternative methods for the replacement of eye irritation testing. ALTEX. 2016;33(1):55-67.
Adriaens E, Barroso J, Eskes C, Hoffmann S, McNamee P, Alépée N, Bessou-Touya S, De Smedt A, De Wever B, Pfannenbecker U, Tailhardat M, Zuang V. Retrospective analysis of the Draize test for serious eye damage/eye irritation: importance of understanding the in vivo endpoints under UN GHS/EU CLP for the development and evaluation of in vitro test methods. Arch Toxicol. 2014;88(3):701-723.

Inhalation Toxicity Testing

Karsta Luettich, Marja Talikka, Frazer J. Lowe, Linsey E. Haswell, Jennifer Park, Marianna D. Gaca, Julia Hoeng. The Adverse Outcome Pathway for Oxidative Stress-Mediated EGFR Activation Leading to Decreased Lung Function. Applied In Vitro Toxicology. Mar 2017, 3(1): 99-109.
Behrsing HP, Huang S, and Constant S. The use of human 3D reconstructed airway cultures for tobacco product evaluation: precision low-volume exposures at the apical site. Applied In Vitro Toxicology. 2017;3(1):1-12.
Mottas I, Milosevic A, Petri-Fink A, Rothen-Rutishauser B, Bourquin C. A rapid screening method to evaluate the impact of nanoparticles on macrophages. Nanoscale. 2017;9(7):2492-2504.
Weisensee D, Poth A, Roemer E, Conroy LL, Schlage WK. Cigarette smoke-induced morphological transformation of Bhas 42 cells in vitro. ATLA. May 2013;41(2):181–9.
Mathis C, Poussin C, Weisensee D, Gebel S, Hengstermann A, Sewer A, Belcastro V, Xiang Y, Ansari S, Wagner S, Hoeng J, Peitsch MC. Human bronchial epithelial cells exposed in vitro to cigarette smoke at the air-liquid interface resemble bronchial epithelium from human smokers. Am J Physiol Lung Cell Mol Physiol. Apr 2013;304(7):L489–L503.

Organs-on-Chips

Bahinski A, Horland R, Huh D, Mummery C, Tagle DA, MacGill T. The promise and potential of “organs-on-chips” as preclinical models. Applied In Vitro Toxicol. 2015;1(4):235-242.
Kim HJ, Ingber DE. Gut-on-a-chip microenvironment induces human intestinal cells to undergo villus differentiation. Integr Biol (Camb). 2013;5(9):1130-1140.
Jang KJ, Mehr AP, Hamilton GA, McPartlin LA, Chung S, Suh KY, Ingber DE. Human kidney proximal tubule-on-a-chip for drug transport and nephrotoxicity assessment. Integr Biol (Camb). 2013;5(9):1119-1129.
Huh D, Leslie DC, Matthews BD, Fraser JP, Jurek S, Hamilton GA, Thorneloe KS, McAlexander MA, Ingber DE. A human disease model of drug toxicity-induced pulmonary edema in a lung-on-a-chip microdevice. Sci Transl Med. 2012;4(159):159ra147.

Pyrogenicity Testing

Hasiwa N, Daneshian M, Bruegger P, Fennrich S, Hochadel A, Hoffmann S, Rivera-Mariani FE, Rockel C, Schindler S, Spreitzer I, Stoppelkamp S, Vysyaraju K, Hartung T. Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test. ALTEX. 2013;30(2):169-208.

Reproductive Toxicity Testing

Wu S, Fisher J, Naciff J, Laufersweiler M, Lester C, Daston G, Blackburn K. Framework for identifying chemicals with structural features associated with the potential to act as developmental or reproductive toxicants. Chem Res Toxicol. 2013;26(12):1840-1861.
Fegert I, Billington R, Botham P, Carney E, FitzGerald RE, Hanley T, Lewis R, Marty MS, Schneider S, Sheets LP, Stahl B, van Ravenzwaay B. Feasibility of the extended one-generation reproductive toxicity study (OECD 443). Reproductive Toxicology. 2012;34(3):331-339.

Shellfish Toxicity Testing

Van Dolah FM, Fire SE, Leighfield TA, Mikulski CM, Doucette GJ. Determination of paralytic shellfish toxins in shellfish by receptor binding assay: collaborative study. J AOAC Int. 2012;95(3):795-812.

Skin Irritation/Corrosion Testing

Kolle SN, Sullivan KM, Mehling A, van Ravenzwaay B, Landsiedel R. Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: substantiating test strategies with data from routine studies. Regul Toxicol Pharmacol. 2013;65(3):366-378.
Casas JW, Lewerenz GM, Rankin EA, Willoughby Sr. JA, Blakeman LC, McKim Jr. JM, Coleman KP. In vitro human skin irritation test for evaluation of medical device extracts. Toxicology in Vitro. 2013;27(8):2175-2183.

Skin Sensitisation Testing

Strickland J, Zang Q, Paris M, Lehmann DM, Allen D, Choksi N, Matheson J, Jacobs A, Casey W, Kleinstreuer N. Multivariate models for prediction of human skin sensitization hazard. J Appl Toxicol. 2017;37(3):347-360.
Zang Q, Paris M, Lehmann DM, Bell S, Kleinstreuer N, Allen D, Matheson J, Jacobs A, Casey W, Strickland J. Prediction of skin sensitization potency using machine learning approaches. J Appl Toxicol. 2017.
Jaworska JS, Natsch A, Ryan C, Strickland J, Ashikaga T, Miyazawa M. Bayesian integrated testing strategy (ITS) for skin sensitization potency assessment: a decision support system for quantitative weight of evidence and adaptive testing strategy. Arch Toxicol. 2015;89(12):2355-2383.
Coleman KP, McNamara LR, Grailer TP, Willoughby JA, Keller DJ, Patel P, Thomas S, Dilworth C. Evaluation of an in vitro human dermal sensitization test for use with medical device extracts. Applied In Vitro Toxicol. 2015;1(2):118-130.
Jaworska J, Dancik Y, Kern P, Gerberick F, Natsch A. Bayesian integrated testing strategy to assess skin sensitization potency: from theory to practice. J Appl Toxicol. 2013;33(11):1353-1364.
Bauch C, Kolle SN, Ramirez T, Eltze T, Fabian E, Mehling A, Teubner W, van Ravenzwaay B, Landsiedel R. Putting the parts together: combining in vitro methods to test for skin sensitizing potentials. Regul Toxicol Pharmacol. 2012;63(3):489-504.
Troutman JA, Foertsch LM, Kern PS, Dai HJ, Quijano M. The incorporation of lysine into the peroxidase peptide reactivity assay for skin sensitization assessments. Toxicol Sci. 2011;122(2):422-436.