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https://www.readbyqxmd.com/read/28301666/adaptation-of-the-keratinosens%C3%A2-skin-sensitisation-test-to-animal-product-free-cell-culture
#1
Nathalie Belot, Bushra Sim, Christopher Longmore Longmore, Lottie Roscoe, Carol Treasure
Skin sensitisation is the process by which a substance leads to an allergic reaction following skin contact. The process has been described as an adverse outcome pathway (AOP), including several key events, from skin penetration and covalent protein binding, to keratinocyte activation, dendritic cell activation and T-lymphocyte proliferation. The in vitro assay KeratinoSens™ measures the activation of keratinocytes. It is fully accepted at a regulatory level (OECD TG 442d) and appropriate for compliance with a range of legislation including the EU Cosmetics Regulation, REACH, and the CLP Regulation...
March 16, 2017: ALTEX
https://www.readbyqxmd.com/read/28230889/quantification-of-the-borderline-range-and-implications-for-evaluating-non-animal-testing-methods-precision
#2
Maria Leontaridou, Daniel Urbisch, Susanne N Kolle, Katharina Ott, Denis S Mulliner, Silke Gabbert, Robert Landsiedel
Testing methods to assess the skin sensitisation potential of a substance usually use threshold criteria to dichotomise continuous experimental read-outs into yes/no conclusions. The threshold criteria are prescribed in the respective OECD test guidelines and the conclusion is used for regulatory hazard assessment, i.e. classification and labelling of the substance. We can identify a borderline range (BR) around the classification threshold within which test results are non-conclusive due to a testing method's biological and technical variability...
February 23, 2017: ALTEX
https://www.readbyqxmd.com/read/28214915/evaluation-of-the-gard-assay-in-a-blind-cosmetics-europe-study
#3
Henrik Johansson, Robin Gradin, Andy Forreryd, Maria Agemark, Kathrin Zeller, Angelica Johansson, Olivia Larne, Erwin van Vliet, Carl Borrebaeck, Malin Lindstedt
Chemical hypersensitivity is an immunological response towards foreign substances, commonly referred to as sensitizers, which gives rise primarily to the clinical symptoms known as allergic contact dermatitis. For the purpose of mitigating risks associated with consumer products, chemicals are screened for sensitizing effects. Historically, such predictive screenings have been performed using animal models. However, due to industrial and regulatory demand, animal models for the purpose of sensitization assessment are being replaced by animal-free testing methods, a global trend that is spreading across industries and market segments...
February 17, 2017: ALTEX
https://www.readbyqxmd.com/read/28214916/facial-expression-an-under-utilised-tool-for-the-assessment-of-welfare-in-mammals
#4
Kris A Descovich, Jennifer Wathan, Matthew C Leach, Hannah M Buchanan-Smith, Paul Flecknell, David Farningham, Sarah-Jane Vick
Animal welfare is a key issue for industries that use or impact upon animals. The accurate identification of welfare states is particularly relevant to the field of bioscience, where the 3Rs framework encourages refinement of experimental procedures involving animal models. The assessment and improvement of welfare states in animals is reliant on reliable and valid measurement tools. Behavioural measures (activity, attention, posture and vocalisation) are frequently used because they are immediate and non-invasive, however no single indicator can yield a complete picture of the internal state of an animal...
February 8, 2017: ALTEX
https://www.readbyqxmd.com/read/28088129/in-vitro-eye-irritation-testing-using-the-open-source-reconstructed-hemicornea-a-ring-trial
#5
Karsten R Mewes, Maria Engelke, Michaela Zorn-Kruppa, Melinda Bartok, Rashmi Tandon, Johanna M Brandner, Dirk Petersohn
Aim of the present ring trial was to prove whether two new methodological approaches for the in vitro classification of eye irritating chemicals can be reliably transferred from the developers' laboratories to other sites.Both test methods are based on the well-established open source reconstructed 3D hemicornea models. In the first approach, the initial depth of injury in the hemicornea model after chemical treatment is derived from the quantitative analysis of histological sections. In the second approach tissue viability, as a measure for corneal damage after chemical treatment, is analyzed separately for epithelium and stroma of the hemicornea model...
January 14, 2017: ALTEX
https://www.readbyqxmd.com/read/28073113/in-vitro-to-in-vivo-extrapolation-for-drug-induced-liver-injury-using-a-pair-ranking-method
#6
Zhichao Liu, Hong Fang, Jürgen Borlak, Ruth Roberts, Weida Tong
Preclinical animal toxicity studies may not accurately predict human toxicity. In light of this, in vitro systems have been developed that have the potential to supplement or even replace animal use. We examined in vitro to in vivo extrapolation (IVIVE) of gene expression data obtained from The Open Japanese Toxicogenomics Project-Genomics Assisted Toxicity Evaluation System (Open TG-GATEs) for 131 compounds given to rats for 28 days, and to human or rat hepatocytes for 24 hours. Notably, a Pair Ranking (PRank) method was developed to assess IVIVE potential with a PRank score based on the preservation of the order of similarity rankings of compound pairs between the platforms using a receiver operating characteristic (ROC) curve analysis to measure area under the curve (AUC)...
January 11, 2017: ALTEX
https://www.readbyqxmd.com/read/28105479/from-cells-to-qsar-alternative-predictive-models-in-toxicology
#7
Yula Sambuy, Anna Maria Bassi, Chiara Scanarotti, Francesca Caloni
No abstract text is available yet for this article.
2017: ALTEX
https://www.readbyqxmd.com/read/28105478/the-need-for-strategic-development-of-safety-sciences
#8
Francois Busquet, Thomas Hartung
The practice of risk assessment and regulation of substances has largely developed as a patchwork of circumstantial additions to a nowadays more or less shared international toolbox. The dominant drivers from the US and Europe have pursued remarkably different approaches in the use of these tools for regulation, i.e., a more risk-based approach in the US and a more precautionary approach in Europe. We argue that there is need for scientific developments not only for the tools but also for their application, i...
2017: ALTEX
https://www.readbyqxmd.com/read/27725989/behavior-of-laboratory-dogs-before-and-after-rehoming-in-private-homes
#9
Dorothea Döring, Ophelia Nick, Alexander Bauer, Helmut Küchenhoff, Michael H Erhard
Although the rehoming of laboratory dogs has gained popularity, a scientific evaluation of the process is lacking. The behavior of 145 laboratory beagles was tested before leaving a research facility (Test 1). The new owners were then surveyed using a standardized telephone interview 1 week (n = 143) and 12 weeks (n = 126) after adoption. The behavior test was repeated with 68 dogs in their new homes 6 weeks after adoption (Test 2). The predictive power of Test 1 or Interview 1 on Test 2 or Interview 2, respectively, as well as the relevance of various factors was analyzed...
2017: ALTEX
https://www.readbyqxmd.com/read/27667476/replacing-reducing-and-refining-the-use-of-animals-in-tuberculosis-vaccine-research
#10
Rachel Tanner, Helen McShane
Tuberculosis (TB) remains a serious global health threat and an improved vaccine is urgently needed. New candidate TB vaccines are tested using preclinical animal models such as mice, guinea pigs, cattle and non-human primates. Animals are routinely infected with virulent Mycobacterium tuberculosis (Mtb) in challenge experiments to evaluate protective efficacy, raising ethical issues regarding the procedure of infection itself, symptoms of disease and humane end-points. We summarize the importance and limitations of animal models in TB vaccine research and review current alternatives and modifications in the context of the NC3Rs framework for replacing, reducing and refining the use of animals for scientific purposes...
2017: ALTEX
https://www.readbyqxmd.com/read/27554434/good-cell-culture-practice-for-stem-cells-and-stem-cell-derived-models
#11
David Pamies, Anna Bal-Price, Anton Simeonov, Danilo Tagle, Dave Allen, David Gerhold, Dezhong Yin, Francesca Pistollato, Takashi Inutsuka, Kristie Sullivan, Glyn Stacey, Harry Salem, Marcel Leist, Mardas Daneshian, Mohan C Vemuri, Richard McFarland, Sandra Coecke, Suzanne C Fitzpatrick, Uma Lakshmipathy, Amanda Mack, Wen Bo Wang, Daiju Yamazaki, Yuko Sekino, Yasunari Kanda, Lena Smirnova, Thomas Hartung
The first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times...
2017: ALTEX
https://www.readbyqxmd.com/read/27463612/design-of-a-high-throughput-human-neural-crest-cell-migration-assay-to-indicate-potential-developmental-toxicants
#12
Johanna Nyffeler, Christiaan Karreman, Heidrun Leisner, Yong Jun Kim, Gabsang Lee, Tanja Waldmann, Marcel Leist
Migration of neural crest cells (NCCs) is one of the pivotal processes of human fetal development. Malformations arise if NCC migration and differentiation are impaired genetically or by toxicants. In the currently available test systems for migration inhibition of NCC (MINC), the manual generation of a cell-free space results in extreme operator dependencies, and limits throughput. Here a new test format was established. The assay avoids scratching by plating cells around a commercially available circular stopper...
2017: ALTEX
https://www.readbyqxmd.com/read/27452664/reference-compounds-for-alternative-test-methods-to-indicate-developmental-neurotoxicity-dnt-potential-of-chemicals-example-lists-and-criteria-for-their-selection-and-use
#13
Michael Aschner, Sandra Ceccatelli, Mardas Daneshian, Ellen Fritsche, Nina Hasiwa, Thomas Hartung, Helena T Hogberg, Marcel Leist, Abby Li, William R Mundi, Stephanie Padilla, Aldert H Piersma, Anna Bal-Price, Andrea Seiler, Remco H Westerink, Bastian Zimmer, Pamela J Lein
There is a paucity of information concerning the developmental neurotoxicity (DNT) hazard posed by industrial and environmental chemicals. New testing approaches will most likely be based on batteries of alternative and complementary (non-animal) tests. As DNT is assumed to result from the modulation of fundamental neurodevelopmental processes (such as neuronal differentiation, precursor cell migration or neuronal network formation) by chemicals, the first generation of alternative DNT tests target these processes...
2017: ALTEX
https://www.readbyqxmd.com/read/27442998/assigning-ethical-weights-to-clinical-signs-observed-during-toxicity-testing
#14
Joakim Ringblom, Elin Törnqvist, Sven Ove Hansson, Christina Rudén, Mattias Öberg
Reducing the number of laboratory animals used and refining experimental procedures to enhance animal welfare are fundamental questions to be considered in connection with animal experimentation. Here, we explored the use of cardinal ethical weights for clinical signs and symptoms in rodents by conducting trade-off interviews with members of Swedish Animal Ethics Committees in order to derive such weights for nine typical clinical signs of toxicity. The participants interviewed represent researchers, politically nominated political nominees and representatives of animal welfare organizations...
2017: ALTEX
https://www.readbyqxmd.com/read/27388676/3-d-nasal-cultures-systems-toxicological-assessment-of-a-candidate-modified-risk-tobacco-product
#15
Anita R Iskandar, Carole Mathis, Florian Martin, Patrice Leroy, Alain Sewer, Shoaib Majeed, Diana Kuehn, Keyur Trivedi, Davide Grandolfo, Maciej Cabanski, Emmanuel Guedj, Celine Merg, Stefan Frentzel, Nikolai V Ivanov, Manuel C Peitsch, Julia Hoeng
In vitro toxicology approaches have evolved from a focus on molecular changes within a cell to understanding of toxicity-related mechanisms in systems that can mimic the in vivo environment. The recent development of three dimensional (3-D) organotypic nasal epithelial culture models offers a physiologically robust system for studying the effects of exposure through inhalation. Exposure to cigarette smoke (CS) is associated with nasal inflammation; thus, the nasal epithelium is relevant for evaluating the pathophysiological impact of CS exposure...
2017: ALTEX
https://www.readbyqxmd.com/read/28009930/incorporation-of-a-metabolizing-system-in-biodetection-assays-for-endocrine-active-substances
#16
Julie Mollergues, Barbara van Vugt-Lussenburg, Christian Kirchnawy, Reka Anna Bandi, Rosan B van der Lee, Maricel Marin-Kuan, Benoit Schilter, Karma C Fussell
The use of in vitro assays is important for the biodetection of endocrine active substances (EAS), reducing and replacing the in vivo studies required for regulatory assessment. However, this approach often fails to take into account the role of biotransformation on the activity of the test substances. A method incorporating an S9 metabolic system into the CALUX-reporter gene assays for estrogen receptor α- and anti-androgen receptor -mediated activities has been developed. Methoxychlor, which is known to exhibit increased estrogenic and anti-androgenic activities after biotransformation, was used to set up the method in ERa and anti-AR CALUX...
December 22, 2016: ALTEX
https://www.readbyqxmd.com/read/27960008/a-tiered-bayesian-approach-to-estimating-of-population-variability-for-regulatory-decision-making
#17
Weihsueh A Chiu, Fred A Wright, Ivan Rusyn
Characterizing human variability in susceptibility to chemical toxicity is a critical issue in regulatory decision-making, but is usually addressed by a default 10-fold safety/uncertainty factor. Feasibility of population-based in vitro experimental approaches to more accurately estimate human variability was demonstrated recently using a large (~1000) panel of lymphoblastoid cell lines. However, routine use of such a large population-based model poses cost and logistical challenges. We hypothesize that a Bayesian approach embedded in a tiered workflow provides efficient estimation of variability and enables a tailored and sensible approach to selection of appropriate sample size...
December 13, 2016: ALTEX
https://www.readbyqxmd.com/read/27883356/a-human-brain-microphysiological-system-derived-from-induced-pluripotent-stem-cells-to-study-neurological-diseases-and-toxicity
#18
David Pamies, Paula Barreras, Katharina Block, Georgia Makri, Anupama Kumar, Daphne Wiersma, Lenna Smirnova, Ce Zhang, Joseph Bressler, Kimberly M Christian, Georgina Harris, Guo-Li Ming, Cindy J Berlinicke, Kelly Kyro, Hongjun Song, Carlos A Pardo, Thomas Hartung, Helena T Hogberg
Human in-vitro models of brain neurophysiology are needed to investigate molecular and cellular mechanisms associated with neurological disorders and neurotoxicity. We have developed a reproducible iPSC-derived human 3D brain microphysiological system (BMPS), comprised of differentiated mature neurons and glial cells (astrocytes and oligodendrocytes) that reproduce neuronal-glial interactions and connectivity. BMPS mature over eight weeks and show the critical elements of neuronal function: synaptogenesis and neuron-to-neuron (e...
November 24, 2016: ALTEX
https://www.readbyqxmd.com/read/27846345/systems-biology-for-organotypic-cell-cultures
#19
Sonia Grego, Edward R Dougherty, Francis J Alexander, Scott S Auerbach, Brian R Berridge, Michael L Bittner, Warren Casey, Philip C Cooley, Ajit Dash, Stephen S Ferguson, Timothy R Fennell, Brian T Hawkins, Anthony J Hickey, Andre Kleensang, Michael N J Liebman, Florian Martin, Elizabeth A Maull, Jason Paragas, Guilin Gary Qiao, Sreenivasa Ramaiahgari, Susan J Sumner, Miyoung Yoon
Translating in vitro biological data into actionable information related to human health holds the potential to improve disease treatment and risk assessment of chemical exposures. While genomics has identified regulatory pathways at the cellular level, translation to the organism level requires a multiscale approach accounting for intra-cellular regulation, inter-cellular interaction, and tissue/organ-level effects. Tissue-level effects can now be probed in vitro thanks to recently developed systems of three-dimensional (3D), multicellular, "organotypic" cell cultures, which mimic functional responses of living tissue...
November 14, 2016: ALTEX
https://www.readbyqxmd.com/read/27831629/alternative-acute-oral-toxicity-assessment-under-reach-based-on-sub-acute-toxicity-values
#20
Andrea Gissi, Kimmo Louekari, Laurence Hoffstadt, Norbert Bornatowicz, Alberto Martin Aparicio
The REACH Regulation requires information on acute oral toxicity for substances produced or imported in quantities greater than one tonne per year. When registering, animal testing should be used as last resort. The standard acute oral toxicity test requires use of animals. Therefore, the European Chemicals Agency examined whether alternative ways exist to generate information on acute oral toxicity. The starting hypothesis was that low acute oral toxicity can be predicted from the results of low toxicity in oral sub-acute toxicity studies...
November 8, 2016: ALTEX
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