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    910 results match your criteria ALTEX[Journal]

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    A standardized method based on pigmented epidermal models evaluates sensitivity against UV-irradiation.
    ALTEX 2018 Apr 13. Epub 2018 Apr 13.
    Translational Center Regenerative Therapies, Fraunhofer Institute for Silicate Research, Würzburg, Germany.
    To protect the human skin from extensive solar radiation, melanocytes produce melanin and disperse it via melanosomes to keratinocytes in the basal and suprabasal layers of the human epidermis. Moreover, melanocytes are associated with pathological skin conditions such as vitiligo and psoriasis. Thus, an in vitro skin model that comprises a defined cutaneous pigmentation system is highly relevant in cosmetic, pharmaceutical and medical research. Read More

    Advanced Good Cell Culture Practice for human primary, stem cell-derived and organoid models as well as microphysiological systems.
    ALTEX 2018 Apr 13. Epub 2018 Apr 13.
    CAAT-Europe, University of Konstanz, Konstanz, Germany.
    A major reason for the current reproducibility crisis in the life sciences is the poor implementation of quality control measures and reporting standards. Improvement is needed, especially regarding increasingly complex in vitro methods. Good Cell Culture Practice (GCCP) was an effort from 1996 to 2005 to develop such minimum quality standards also applicable in academia. Read More

    3S - Systematic, systemic, and systems biology and toxicology.
    ALTEX 2018 ;35(2):139-162
    Johns Hopkins University, Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
    A biological system is more than the sum of its parts - it accomplishes many functions via synergy. Deconstructing the system down to the molecular mechanism level necessitates the complement of reconstructing functions on all levels, i.e. Read More

    Investigation of ruminant xenobiotic metabolism in a modified rumen simulation system (RUSITEC).
    ALTEX 2018 Mar 12. Epub 2018 Mar 12.
    BASF SE Global Environmental & Consumer Safety, Crop Protection, Limburgerhof, Germany.
    The approving agencies for plant protection agents request xenobiotic metabolism and residue studies in rats, farm animals and plants (e.g. EU regulation 1107/2009) according to OECD guidelines. Read More

    Testing vaginal irritation with the hen's egg test-chorioallantoic membrane assay.
    ALTEX 2018 Mar 11. Epub 2018 Mar 11.
    CICS, UBI - Health Sciences Research Center, Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal.
    The HET-CAM (Hen's Egg Test-Chorioallantoic Membrane) assay is an in vitro alternative to the in vivo Draize Rabbit Eye test that mimics vascular changes in the chorioallantoic membrane. This qualitative method assesses the irritancy potential of chemicals. The CAM responds to injury with an inflammatory process similar to that in the rabbit eye's conjunctival tissue. Read More

    The US Federal Tox21 Program: A strategic and operational plan for continued leadership.
    ALTEX 2018 8;35(2):163-168. Epub 2018 Mar 8.
    National Center for Toxicological Research, Food and Drug Administration, Silver Spring, MD, USA.
    The traditional approaches to toxicity testing have posed multiple challenges for evaluating the safety of commercial chemicals, pesticides, food additives/contaminants, and medical products.The challenges include number of chemicals that need to be tested, time and resource intensive nature of traditional toxicity tests, and unexpected adverse effects that occur in pharmaceutical clinical trials despite the extensive toxicological testing.Over a decade ago, the U. Read More

    Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity.
    ALTEX 2018 02 23. Epub 2018 Feb 23.
    Center for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany.
    Multiple non-animal-based test methods have never been formally validated. In order to use such new approach methods (NAMs) in a regulatory context, criteria to define their readiness are necessary. The field of developmental neurotoxicity (DNT) testing is used to exemplify the application of readiness criteria. Read More

    A high-throughput approach to identify specific neurotoxicants/ developmental toxicants in human neuronal cell function assays.
    ALTEX 2018 Jan 21. Epub 2018 Jan 21.
    In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany.
    The (developmental) neurotoxicity hazard is still unknown for most chemicals. Establishing a test battery covering most of the relevant adverse outcome pathways may close this gap, without requiring a huge animal experimentation program. Ideally, each of the assays would cover multiple mechanisms of toxicity. Read More

    In silico methods - Computational alternatives to animal testing.
    ALTEX 2018 ;35(1):124-126
    Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.

    Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US.
    ALTEX 2018 ;35(1):3-25
    Johns Hopkins Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
    The US Food and Drug Administration (FDA) has premarket review authority over food additives, but a food manufacturer may, according to the legislation, intentionally add a substance to human food or animal food without their premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use. Generally recognized as safe (GRAS) implies that the current scientific community agrees on the adequacy of how data is generated. This system has come under public pressure because of doubts as to its efficiency and the FDA's recent GRAS rule is part of the response. Read More

    RPTEC/TERT1 cells form highly differentiated tubules when cultured in a 3D matrix.
    ALTEX 2018 2;35(2):223-234. Epub 2017 Dec 2.
    Human and Environmental Toxicology, Department of Biology, University of Konstanz, Konstanz, Germany.
    The proximal tubule is the primary site for renal solute reabsorption and secretion and thus a main target for drug-induced toxicity. Current nonclinical methods using 2D cell cultures are unable to fully recapitulate clinical drug responses mainly due to limited in vitro functional lifespan. Since extracellular matrices are known to be key regulators of cell development, culturing cells on classic 2D plastic surfaces inevitably results in loss of differentiation. Read More

    Recommendations to improve the EU non-technical summaries of animal experiments.
    ALTEX 2018 29;35(2):193-210. Epub 2017 Nov 29.
    Animal Welfare Academy, German Animal Welfare Federation, Neubiberg, Germany.
    Under the new Directive 2010/63/EC, member states have to publish non-technical summaries (NTS) of the projects involving animals that they authorise. These summaries must include information on the objectives of the project including the predicted harm and benefits and the number and types of animals to be used. Summaries should also demonstrate compliance with the 3Rs. Read More

    Co-culture of human alveolar epithelial (hAELVi) and macrophage (THP-1) cell lines.
    ALTEX 2018 23;35(2):211-222. Epub 2017 Nov 23.
    Department Drug Delivery (DDEL), Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS), Saarland University, Saarbrücken, Germany.
    The air-blood barrier is mainly composed of alveolar epithelial cells and macrophages. Whereas the epithelium acts as a diffusional barrier, macrophages represent an immunological barrier, in particular for larger molecules and nanoparticles. This paper describes a new co-culture of human cell lines representing both cell types. Read More

    The GARD platform for potency assessment of skin sensitizing chemicals.
    ALTEX 2017 12;34(4):539-559. Epub 2017 Apr 12.
    Department of Immunotechnology, Medicon Village, Lund, Sweden.
    Contact allergy induced by certain chemicals is a common health concern, and several alternative methods have been developed to fulfill the requirements of European legislation with regard to hazard assessment of potential skin sensitizers. However, validated methods, which provide information about the potency of skin sensitizers, are still lacking. The cell-based assay Genomic Allergen Rapid Detection (GARD), targeting key event 3, dendritic cell activation, of the skin sensitization AOP, uses gene expression profiling and a machine learning approach for the prediction of chemicals as sensitizers or non-sensitizers. Read More

    Computational approaches to chemical hazard assessment.
    ALTEX 2017 ;34(4):459-478
    Johns Hopkins Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
    Computational prediction of toxicity has reached new heights as a result of decades of growth in the magnitude and diversity of biological data. Public packages for statistics and machine learning make model creation faster. New theory in machine learning and cheminformatics enables integration of chemical structure, toxicogenomics, simulated and physical data in the prediction of chemical health hazards, and other toxicological information. Read More

    State-of-the-art and new options to assess T cell activation by skin sensitizers: Cosmetics Europe Workshop.
    ALTEX 2018 2;35(2):179-192. Epub 2017 Oct 2.
    Henkel AG & Co. KGaA, Düsseldorf, Germany.
    Significant progress has been made in the development and validation of non-animal test methods for skin sensitization assessment. At present, three of the four key events of the Adverse Outcome Pathway (AOP) are assessable by OECD-accepted in vitro methods. The fourth key event describes the immunological response in the draining lymph node where activated dendritic cells present major histocompatibility complex-bound chemically modified peptides to naive T cells, thereby priming the proliferation of antigen-specific T cells. Read More

    Integrated strategy for mutagenicity prediction applied to food contact chemicals.
    ALTEX 2018 18;35(2):169-178. Epub 2017 Sep 18.
    Chemical Food Safety Group, Nestlé Research Center, Lausanne, Switzerland.
    Food contamination due to unintentional leakage of chemicals from food contact materials (FCM) is a source of increasing concern. Since for many of these substances, only limited or no toxicological data are available, the development of alternative methodologies to establish rapidly and cost-efficiently level of safety concern is critical to ensure adequate consumer protection. Computational toxicology methods are considered the most promising solutions to cope with this data gap. Read More

    Ex vivo model unravelling cell distribution effect in hydrogels for cartilage repair.
    ALTEX 2018 8;35(1):65-76. Epub 2017 Sep 8.
    Department of Oral and Maxillofacial Surgery & Special Dental Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
    The implantation of chondrocyte-laden hydrogels is a promising cartilage repair strategy. Chondrocytes can be spatially positioned in hydrogels and thus in defects, while current clinical cell therapies introduce chondrocytes in the defect depth. The main aim of this study was to evaluate the effect of spatial chondrocyte distribution on the reparative process. Read More

    Prediction of acute inhalation toxicity using in vitro lung surfactant inhibition.
    ALTEX 2018 17;35(1):26-36. Epub 2017 Aug 17.
    National Research Centre for the Working Environment, Copenhagen, Denmark.
    Private consumers and professionals may experience acute inhalation toxicity after inhaling aerosolized impregnation products. The distinction between toxic and non-toxic products is difficult to make for producers and product users alike, as there is no clearly described relationship between the chemical composition of the products and induction of toxicity. The currently accepted method for determination of acute inhalation toxicity is based on experiments on animals; it is time-consuming, expensive and causes stress for the animals. Read More

    Fetal Bovine Serum (FBS): Past - Present - Future.
    ALTEX 2018 9;35(1):99-118. Epub 2017 Aug 9.
    Division of Physiology, Medical University Innsbruck, Innsbruck, Austria.
    The supplementation of culture medium with fetal bovine serum (FBS, also referred to as "fetal calf serum") is still common practice in cell culture applications. Due to a number of disadvantages in terms of quality and reproducibility of in vitro data, animal welfare concerns, and in light of recent cases of fraudulent marketing, the search for alternatives and the development of serum-free medium formulations has gained global attention. Here, we report on the 3rd Workshop on FBS, Serum Alternatives and Serum-free Media, where regulatory aspects, the serum dilemma, alternatives to FBS, case-studies of serum-free in vitro applications, and the establishment of serum-free databases were discussed. Read More

    Use of high-throughput in vitro toxicity screening data in cancer hazard evaluations by IARC Monograph Working Groups.
    ALTEX 2018 24;35(1):51-64. Epub 2017 Jul 24.
    Department of Veterinary Integrative Biosciences, Texas A&M University, College Station, TX, USA.
    Evidence regarding carcinogenic mechanisms serves a critical role in International Agency for Research on Cancer (IARC) Monograph evaluations. Three recent IARC Working Groups pioneered inclusion of the US Environmental Protection Agency (EPA) ToxCast program high-throughput screening (HTS) data to supplement other mechanistic evidence. In Monograph V110, HTS profiles were compared between perfluorooctanoic acid (PFOA) and prototypical activators across multiple nuclear receptors. Read More

    Thresholds of Toxicological Concern - Setting a threshold for testing below which there is little concern.
    ALTEX 2017 ;34(3):331-351
    Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
    Low dose, low risk; very low dose, no real risk. Setting a pragmatic threshold below which concerns become negligible is the purpose of thresholds of toxicological concern (TTC). The idea is that such threshold values do not need to be established for each and every chemical based on experimental data, but that by analyzing the distribution of lowest or no-effect doses of many chemicals, a TTC can be defined - typically using the 5th percentile of this distribution and lowering it by an uncertainty factor of, e. Read More

    A validated algorithm for selecting non-toxic chemical concentrations.
    ALTEX 2018 26;35(1):37-50. Epub 2017 Jun 26.
    EPF Lausanne, School of Architecture, Civil and Environmental Engineering, Lausanne, Switzerland.
    The maximal chemical concentration that causes an acceptably small or no effect in an organism or isolated cells is an often-sought-after value in toxicology. Existing approaches to derive this value have raised several concerns; thus, it is often chosen case-by-case based on personal experience. To overcome this ambiguity, we propose an approach for choosing the non-toxic concentration (NtC) of a chemical in a rational, tractable way. Read More

    From in vivo to in vitro: The medical device testing paradigm shift.
    ALTEX 2017 25;34(4):479-500. Epub 2017 May 25.
    Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
    Amid growing efforts to advance the replacement, reduction, and refinement of the use of animals in research, there is a growing recognition that in vitro testing of medical devices can be more effective, both in terms of cost and time, and also more reliable than in vivo testing. Although the technological landscape has evolved rapidly in support of these concepts, regulatory acceptance of alternative testing methods has not kept pace. Despite the acceptance by regulators of some in vitro tests (cytotoxicity, gene toxicity, and some hemocompatibility assays), many toxicity tests still rely on animals (irritation, sensitization, acute toxicity, reproductive/developmental toxicity), even where other industrial sectors have already abandoned them. Read More

    Extracorporeal perfusion of isolated organs of large animals - Bridging the gap between in vitro and in vivo studies.
    ALTEX 2018 3;35(1):77-98. Epub 2017 May 3.
    Division of Veterinary Clinical Sciences, Royal (Dick) School of Veterinary Studies and The Roslin Institute, Easter Bush Campus, Midlothian, UK.
    Since the early 20th century, extracorporeal perfusion of large animal organs has been used to investigate a broad variety of research questions, thereby overcoming common drawbacks of in vitro studies without suffering from ethical concerns associated with live animal research. The technique is in accordance with the 3R principles and represents an excellent opportunity to investigate the physiology of organs in detail under standardized conditions. It is also suitable for the translation of basic pre-clinical research into a more relevant arena prior to or avoiding live animal research altogether. Read More

    Adaptation of the KeratinoSens™ skin sensitization test to animal-product-free cell culture
    ALTEX 2017 12;34(4):560-564. Epub 2017 Apr 12.
    XCellR8 Ltd, The Innovation Centre, Sci-Tech Daresbury, Daresbury, Cheshire, UK.
    Skin sensitization is the process by which a substance induces 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. Read More

    Non-animal approaches for toxicokinetics in risk evaluations of food chemicals.
    ALTEX 2017 12;34(4):501-514. Epub 2017 Apr 12.
    RIKILT Wageningen University and Research, Wageningen, the Netherlands.
    The objective of the present work was to review the availability and predictive value of non-animal toxicokinetic approaches and to evaluate their current use in European risk evaluations of food contaminants, additives and food contact materials, as well as pesticides and medicines. Results revealed little use of quantitative animal or human kinetic data in risk evaluations of food chemicals, compared with pesticides and medicines. Risk evaluations of medicines provided sufficient in vivo kinetic data from different species to evaluate the predictive value of animal kinetic data for humans. Read More

    The borderline range of toxicological methods: Quantification and implications for evaluating precision.
    ALTEX 2017 23;34(4):525-538. Epub 2017 Feb 23.
    BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
    Test methods to assess the skin sensitization potential of a substance usually use threshold criteria to dichotomize 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. Read More

    Facial expression: An under-utilised tool for the assessment of welfare in mammals.
    ALTEX 2017 8;34(3):409-429. Epub 2017 Feb 8.
    Psychology, Faculty of Natural Sciences, University of Stirling, Stirling, United Kingdom.
    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 depends on reliable and valid measurement tools. Read More

    Evaluation of the GARD assay in a blind Cosmetics Europe study.
    ALTEX 2017 17;34(4):515-523. Epub 2017 Feb 17.
    Dept. of Immunotechnology, Lund University, Lund, Sweden.
    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. Read More

    The need for strategic development of safety sciences.
    ALTEX 2017 ;34(1):3-21
    Center for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany.
    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. Read More

    In vitro eye irritation testing using the open source reconstructed hemicornea - a ring trial.
    ALTEX 2017 14;34(3):430-434. Epub 2017 Jan 14.
    Henkel AG & Co. KGaA; Düsseldorf, Germany.
    The aim of the present ring trial was to test 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 after chemical treatment in the hemicornea model is derived from the quantitative analysis of histological sections. Read More

    In vitro to in vivo extrapolation for drug-induced liver injury using a pair ranking method.
    ALTEX 2017 11;34(3):399-407. Epub 2017 Jan 11.
    National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, USA.
    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. Read More

    Incorporation of a metabolizing system in biodetection assays for endocrine active substances.
    ALTEX 2016 Dec 22. Epub 2016 Dec 22.
    Chemical Food Safety, Nestlé Research Centre, Lausanne, Switzerland.
    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. Read More

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