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Authors:Ceyda Caliskan, Deniz Simsek, Charlotte Leese, Ciara Doran, Elizabeth Seward, Andrew A Peden, Bazbek Davletov Abstract: Botulinum neurotoxin type A (BoNT/A) is a widely used biopharmaceutic for the treatment of neurological diseases and aesthetic medicine, allowing months-long paralysis of target muscles and glands. Large numbers of mice are used for multiple botulinum applications including batch release potency testing, antitoxin testing, countermeasure development and basic research. The mouse bioassay (MBA) has historically been the industry gold-standard in the botulinum field and is still heavily used for... Citation: ALTEX PubDate: 2024-07-29 DOI: 10.14573/altex.2312071
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Authors:Yasir H Siddique, Tanveer Beg, Himanshi Varshney, Iqra Subhan, Kajal Varshney, Javeria Fatima, Mohammad A Akbarsha Abstract: No abstract Citation: ALTEX PubDate: 2024-07-17 DOI: 10.14573/altex.2403151
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Authors:Marita Meurer, Manasa Nandimandalam, Maren von Köckritz-Blickwede, André Bleich Abstract: No abstract Citation: ALTEX PubDate: 2024-07-17 DOI: 10.14573/altex.2407021
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Authors:Stefano Lorenzetti, Milena Mikhail, Laura Di Benedetto, Elena Dellambra, Cristina M Failla, Sara M Giannitelli, Riccardo Levato, Alessia Longoni, Valeria Bartolocci, Daniela Lulli, Sofia Raniolo, Isabella De Angelis Abstract: No abstract Citation: ALTEX PubDate: 2024-07-17 DOI: 10.14573/altex.2402261
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Authors:Fenna C M Sillé, Francois Busquet, Suzie Fitzpatrick, Kathrin Herrmann, Lisa Leenhouts-Martin, Thomas Luechtefeld, Alexandra Maertens, Gary W Miller, Lena Smirnova, Katya Tsaioun, Thomas Hartung Abstract: The Human Exposome Project aims to revolutionize our understanding of how environmental exposures affect human health by systematically cataloging and analyzing the myriad exposures individuals encounter throughout their lives. This initiative draws a parallel with the Human Genome Project, expanding the focus from genetic factors to the dynamic and complex nature of environ-mental interactions. The project leverages advanced methodologies such as omics technologies, biomonitoring,... Citation: ALTEX PubDate: 2024-07-17 DOI: 10.14573/altex.2407081
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Authors:Daniel Ehrlich, Shagun Krishna, Nicole Kleinstreuer Abstract: Dysregulation of Vascular Endothelial Growth Factor (VEGF) and its receptor (VEGFR) contributes to atherosclerosis and cardiovascular disease (CVD), making it a potential target for CVD risk assessment. High throughput screening (HTS) approaches have resulted in large-scale in vitro data, providing mechanistic information that can help assess chemical toxicity and identify molecular-initiating events (MIEs) of adverse outcome pathways (AOPs). AOPs represent a logical sequence of biological... Citation: ALTEX PubDate: 2024-07-09 DOI: 10.14573/altex.2403211
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Authors:Susan Debad, David Allen, Omari Bandele, Colin Bishop, Michaela Blaylock, Paul Brown, Maureen K Bunger, Julia Y Co, Lynn Crosby, Amber B Daniel, Steve S Ferguson, Kevin Ford, Gonçalo Gamboa da Costa, Kristin H Gilchrist, Matthew W Grogg, Maureen Gwinn, Thomas Hartung, Simon P Hogan, Ye Eun Jeong, George En Kass, Elaina Kenyon, Nicole C Kleinstreuer, Ville Kujala, Patrik Lundquist, Joanna Matheson, Shaun D McCullough, Angela Melton-Celsa, Steven Musser, Ilung Oh, Oluwakemi B Oyetade, Sarita U Patil, Elijah J Petersen, Nakissa Sadrieh, Christie M Sayes, Benjamin S Scruggs, Yu-Mei Tan, Bill Thelin, M Tyler Nelson, José V Tarazona, John F Wambaugh, Jun-Young Yang, Changwoo Yu, Suzanne Fitzpatrick Abstract: The webinar series and workshop titled “Trust Your Gut: Establishing Confidence in Gastrointestinal Models – An Overview of the State of the Science and Contexts of Use” was co-organized by NICEATM, NIEHS, FDA, EPA, CPSC, DoD, and the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) and hosted at the National Institutes of Health in Bethesda, MD, USA on October 11-12, 2023. New approach methods (NAMs) for assessing issues of gastrointestinal tract (GIT)- related toxicity offer... Citation: ALTEX PubDate: 2024-06-20 DOI: 10.14573/altex.2403261
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Authors:Alexander Gurjanov, Lea A I Vaas, Thomas Steger-Hartmann Abstract: Virtual control groups (VCGs) created from historical control data (HCD) can reduce the number of concurrent control group animals needed in regulatory toxicity studies by up to 25%. This study investigates the performance of VCGs on statistical outcomes of body weight development between treatment and control groups in legacy studies. The objective is to reproduce the statistical outcomes of 28-day sub-chronic studies (legacy studies) after replacing the concurrent control group with virtual... Citation: ALTEX PubDate: 2024-05-29 DOI: 10.14573/altex.2403141
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Authors:Nathalie Alépée, Els Adriaens Abstract: Currently there are two OECD-adopted defined approaches (DA) for eye hazard identification of non-surfactant liquids (OECD TG 467). The current study aimed to develop a DA for eye hazard identification of solid chemicals according to the three UN GHS categories (Cat.1, Cat. 2, No Cat.): the DAS. The DAS combines two test methods described in OECD TG 437 and TG 492. The DAS was developed based on in-depth statistical analysis of a database on solids containing in vitro and historically curated in... Citation: ALTEX PubDate: 2024-05-18 DOI: 10.14573/altex.2401191
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Authors:Pelin L Candarlioglu, Louise Delsing, Lauren Gauthier, Lauren Lewis, George Papadopoulos, May Freag, Tom S Chan, Kimberly A Homan, Mick D Fellows, Amy Pointon, Kyle Kojala Abstract: Microphysiological systems (MPS) are gaining broader application in the pharmaceutical industry but have primarily been leveraged in early discovery toxicology and pharmacology studies with small molecules. The adoption of MPS offers a promising avenue to reduce animal use, improve in-vitro-to-in-vivo translation of pharmacokinetics/pharmacodynamics and toxicity correlation, and provide mechanistic understanding of model species suitability. While MPS have demonstrated utility in these areas... Citation: ALTEX PubDate: 2024-05-15 DOI: 10.14573/altex.2402201
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Authors:Monica Vaccari, Stefania Serra, Andrea Ranzi, Federico Aldrovandi, Giangabriele Maffei, Maria G Mascolo, Ada Mescoli, Elisa Montanari, Gelsomina Pillo, Francesca Rotondo, Ivan Scaroni, Lorenzo Vaccari, Cristina Zanzi, Tony Fletcher, Martin Paparella, Annamaria Colacci Abstract: Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) are the major components of long-chain per- and polyfluorinated alkyl substances (PFAS), known for their chemical stability and environmental persistence. Even if PFOA and PFOS have been phased out or are limited in use, they still represent a concern for human and environmental health. Several studies have been performed to highlight the toxicological behavior of these chemicals and their mode of action (MoA). Data have... Citation: ALTEX PubDate: 2024-04-23 DOI: 10.14573/altex.2310281
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Authors:Colleen M Pike, Bailey Zwarycz, Bryan E McQueen, Mariana Castillo, Catherine Barron, Jeremy M Morowitz, James A Levi, Dhiral Phadke, Michele Balik-Meisner, Deepak Mav, Ruchir Shah, Danielle L Cunningham Glasspoole, Ron Laetham, William Thelin, Maureen K Bunger, Elizabeth M Boazak Abstract: Animal models have historically been poor preclinical predictors of gastrointestinal (GI) directed therapeutic efficacy and drug-induced GI toxicity. Human stem and primary cell-derived culture systems are a major focus of efforts to create biologically relevant models that enhance preclinical predictive value of intestinal efficacy and toxicity. The inherent variability in stem cell-based cultures makes development of useful models a challenge; the stochastic nature of stem cell differentiation... Citation: ALTEX PubDate: 2024-04-20 DOI: 10.14573/altex.2309221
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Authors:Syed Z Rahman, Alam Anam, Ankita Pandey, Rohit Bisht, Mohammad A Akbarsha Abstract: No abstract Citation: ALTEX PubDate: 2024-04-18 DOI: 10.14573/altex.2402141
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Authors:Michael Balls, Rolf Bass, Rodger Curren, Julia Fentem, Alan Goldberg, Thomas Hartung, Kathrin Herrmann, Nicole C Kleinstreuer, Lisa Libowitz, John Parascandola, Andrew Rowan, Horst Spielmann, Martin L Stephens, Russell S Thomas, Katya Tsaioun Abstract: When The Principles of Humane Experimental Technique was published in 1959, authors William Russell and Rex Burch had a modest goal: to make researchers think about what they were doing in the laboratory – and to do it more humanely. Sixty years later, their groundbreaking book was celebrated for inspiring a revolution in science and launching a new field: The 3Rs of alternatives to animal experimentation. On November 22, 2019, some pioneering and leading scientists and researchers in the field... Citation: ALTEX PubDate: 2024-04-17 DOI: 10.14573/altex.2403061
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Authors:Augusto Vitale, Maurilio Calleri, Francesca Caloni, Cristina M Failla, Paola Granata, Laura Gribaldo, Urte Jaeh, Michela Kuan, Stefano Lorenzetti, Francesco Nevelli, Giulia Ranaldi, Irene Ruspantini, Orsola R Salva, Lena Smirnova, Julia Steitz, Luigia Trabace, Zoe Windsor, Isabella De Angelis Abstract: No abstract Citation: ALTEX PubDate: 2024-04-16 DOI: 10.14573/altex.2402121
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Authors:Lena Smirnova, Helena T Hogberg, Marcel Leist, Thomas Hartung Abstract: Developmental neurotoxicity (DNT) testing has seen enormous progress over the last two decades. Preceding even the publication of the animal-based OECD test guideline for DNT testing in 2007, a series of non-animal technology workshops and conferences that started in 2005 has shaped a community that has delivered a comprehensive battery of in vitro test methods (DNT IVB). Its data interpretation is now covered by a very recent OECD guidance (No. 377). Here, we overview the progress in the field,... Citation: ALTEX PubDate: 2024-04-05 DOI: 10.14573/altex.2403281
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Authors:Anne Gourmelon, Philippe Hubert, Elise Grignard, Lisa Baumann, Sharon Munn, Cécile Michel Abstract: The 4th Annual Forum on Endocrine Disrupters organized by the European Commission brought together the authors of this article around the topic: “From bench to validated test guidelines: (pre)validation of test methods”. Validation activities are meant to demonstrate the relevance and reliability of methods and approaches used in regulatory safety testing. These activities are essential to facilitate regulatory use, still they are largely underfunded and unattractive to the scientific... Citation: ALTEX PubDate: 2024-03-19 DOI: 10.14573/altex.2403051
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Authors:Katy Taylor, Tilo Weber, Laura Rego Alvarez Abstract: Following a review of Directive 2010/63/EU on the protection of animals used for scientific purposes in the European Union (EU), non-technical project summaries (NTS) of all approved projects must be published in a central database using a standard template. Our initial review of the NTS reported in ALTEX in 2018 had found the NTS to be deficient in their accessibility and quality, notably the “adverse effects” section where the harms to the animals are meant to be described. Here we repeat our... Citation: ALTEX PubDate: 2024-03-16 DOI: 10.14573/altex.2310181
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Authors:Nico Müller Abstract: Since the late 2010s, the idea of phase-out planning for animal experimentation (PPAE) has come to the foreground of political debates, but central notions and arguments are understood differently by different participants and stand in need of clarification. This article draws on public communications on ten political projects related to PPAE to propose a philosophical explication of PPAE and to articulate the proponents’ central moral argument. According to the argument, the phase-out of... Citation: ALTEX PubDate: 2024-03-02 DOI: 10.14573/altex.2312041
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Authors:Han-Hsuan D Tsai, Lucie C Ford, Zunwei Chen, Allison N Dickey, Fred A Wright, Ivan Rusyn Abstract: Per- and polyfluoroalkyl substances (PFAS) are chemicals with important applications; they are persistent in the environment and may pose human health hazards. Regulatory agencies are considering restrictions and bans of PFAS; however, little data exists for informed decisions. Several prioritization strategies were proposed for evaluation of potential hazards of PFAS. Structure-based grouping could expedite the selection of PFAS for testing; still, the hypothesis that structure-effect... Citation: ALTEX PubDate: 2024-03-02 DOI: 10.14573/altex.2311031
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Authors:Monica Piergiovanni, Milena Mennecozzi, Stavroula Sampani, Maurice Whelan Abstract: No abstract Citation: ALTEX PubDate: 2024-02-28 DOI: 10.14573/altex.2401231
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Authors:Steven J Kunnen, Emma Arnesdotter, Christian Tobias Willenbockel, Mathieu Vinken, Bob van de Water Abstract: Next generation risk assessment of chemicals revolves around the use of mechanistic information without animal experimentation. In this regard, toxicogenomics has proven to be a useful tool to elucidate the underlying mechanisms of adverse effects of xenobiotics. In the present study, two widely used human in vitro hepatocyte culture systems, namely primary human hepatocytes (PHH) and human hepatoma HepaRG cells, were exposed to liver toxicants known to induce liver cholestasis, steatosis or... Citation: ALTEX PubDate: 2024-02-20 DOI: 10.14573/altex.2309201
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Authors:Alexandra Maertens, Eric Antignac, Emilio Benfenati, Denise Bloch, Ellen Fritsche, Sebastian Hoffmann, Joanna Jaworska, George Loizou, Kevin McNally, Przemyslaw Piechota, Erwin L Roggen, Marc Teunis, Thomas Hartung Abstract: Both because of the shortcomings of existing risk assessment methodologies, as well as newly available tools to predict hazard and risk with machine learning approaches, there has been an emerging emphasis on probabilistic risk assessment. Increasingly sophisticated AI models can be applied to a plethora of exposure and hazard data to obtain not only predictions for particular endpoints but also to estimate the uncertainty of the risk assessment outcome. This provides the basis for a shift from... Citation: ALTEX PubDate: 2024-01-12 DOI: 10.14573/altex.2310301
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Authors:Eike Cöllen, Yaroslav Tanaskov, Anna-Katharina Holzer, Michelle Dipalo, Jasmin Schäfer, Udo Kraushaar, Marcel Leist Abstract: Many laboratory procedures generate data on properties of chemicals, but they cannot be equated with toxicological "test methods". This apparent discrepancy is not limited to in vitro testing, using animal-free new approach methods (NAM), but also applies to animal-based testing approaches. Here, we give a brief overview of the differences between data generation and the setup or use of a complete test method. While there is excellent literature available on this topic for specialists (GIVIMP... Citation: ALTEX PubDate: 2024-01-11 DOI: 10.14573/altex.2401041
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Authors:Marianna Rosso, Simona E Doneva, David W Howells, Cathalijn Hc Leenaars, Benjamin V Ineichen Abstract: No abstract Citation: ALTEX PubDate: 2024-01-11 DOI: 10.14573/altex.2310251
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Authors:Miriam A Zemanova, Silvia Frey Abstract: No abstract Citation: ALTEX PubDate: 2024-01-10 DOI: 10.14573/altex.2311171
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Authors:Alexandra Maertens, Thomas Luechtefeld, Jean Knight, Thomas Hartung Abstract: Green toxicology is marching chemistry into the 21st century. This emerging framework will transform how chemical safety is evaluated by incorporating evaluation of the hazards, exposures, and risks associated with chemicals into early product development in a way that minimizes adverse impacts on human and environmental health. The goal is to minimize toxic threats across entire supply chains through smarter designs and policies. Traditional animal testing methods are replaced by faster,... Citation: ALTEX PubDate: 2024-01-09 DOI: 10.14573/altex.2312291
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