This Performance-Based Test Guideline (PBTG) describes in vitro assays, which provide the methodology of Stably Transfected Transactivation to detect Estrogen Receptor Agonists and Antagonists (ER TA assays).
The EASZY assay is a mechanism-based in vivo screening assay designed to detect endocrine active chemicals acting as agonist through estrogen receptors (ERs), by inducing the expression of the green fluorescent protein (GFP) driven by the cyp19a1b promoter. The EASZY assay allows for the detection of estrogenic activity of chemicals on transgenic tg(cyp19a1b:GFP) Zebrafish embryos exposed for 96 hours during the embryonic stages of development.
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...
**Selected for Doody's Core Titles® 2024 in Toxicology** Reproductive and Developmental Toxicology, Third Edition is a comprehensive and authoritative resource, providing the latest literature on this complex subject by focusing on three core components - parent, placenta and fetus - and the continuous changes that occur in each. Enriched with relevant references describing every aspect of reproductive toxicology, this revised and updated resource addresses the totality of the subject, discussing a broad range of topics including nanoparticles and radiation, gases and solvents, smoking, alcohol and drugs of abuse, and metals, among others. In addition, it is the only resource to include reproductive and developmental toxicity in domestic animals, fish and wildlife With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages. Completely revised and updated to include the most recent developments in the field, this book is an essential resource for advanced students and researchers in toxicology, as well as biologists, pharmacologists and teratologists from academia, industry and regulatory agencies. - Provides a complete, up-to-date, integrated source of information on the key risk stages during reproduction and development - Offers diverse and unique in vitro and in vivo toxicity models for reproductive and developmental toxicity testing in a user-friendly format that assists in comparative analysis - Includes new chapters on developments in systems toxicology and predictive modeling of male developmental toxicity, adverse outcome pathways in reproductive and developmental toxicology, ovarian and endometrial toxicity, developmental neurotoxicity of air pollution, and more
This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science.Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification.In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.
Hayes’ Principles and Methods of Toxicology has long been established as a reliable reference to the concepts, methodologies, and assessments integral to toxicology. The new sixth edition has been revised and updated while maintaining the same high standards that have made this volume a benchmark resource in the field. With new authors and new chapters that address the advances and developments since the fifth edition, the book presents everything toxicologists and students need to know to understand hazards and mechanisms of toxicity, enabling them to better assess risk. The book begins with the four basic principles of toxicology—dose matters, people differ, everything transforms, and timing is crucial. The contributors discuss various agents of toxicity, including foodborne, solvents, crop protection chemicals, radiation, and plant and animal toxins. They examine various methods for defining and measuring toxicity in a host of areas, including genetics, carcinogenicity, toxicity in major body systems, and the environment. This new edition contains an expanded glossary reflecting significant changes in the field. New topics in this edition include: The importance of dose–response Systems toxicology Food safety The humane use and care of animals Neurotoxicology The comprehensive coverage and clear writing style make this volume an invaluable text for students and a one-stop reference for professionals.
The present Key Event based Test Guideline (TG) addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This TG is proposed to address the activation of dendritic cells, which is one Key Event on the Adverse Outcome Pathway (AOP) for Skin Sensitisation. It provides four in vitro test methods addressing the same Key Event on the AOP: (i) the human cell Line Activation Test or h-CLAT method, (ii) the U937 Cell Line Activation Test or U-SENS, (iii) the Interleukin-8 Reporter Gene Assay or IL-8 Luc assay and (iv) the Genomic Allergen Rapid Detection for assessment of skin sensitisers (GARDTMskin). All of them are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. The test methods described in this TG either quantify the change in the expression of cell surface marker(s) CD54 and CD86, the cytokine IL-8, or a series of genes (genomic biomarker signature) that are associated with the process of activation of monocytes and DC following exposure to sensitisers.
This Performance-Based Test Guideline (PBTG) describes in vitro assays, which provide the methodology of Stably Transfected Transactivation to detect Estrogen Receptor Agonists and Antagonists (ER TA assays).
The second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development. This second volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Select topics include: Evolution of Artificial Intelligence (AI) technologies and the impact on toxicologic pathology. Current approaches to carcinogenicity testing. Predicting drug-drug interactions. Current understanding of idiosyncratic drug reaction. Assessing cardiovascular risks beyond QT interval. Use of 3D cell cultures in toxicology and ADME. Development of small molecule-antibody complexes. Differentiating adverse from non-adverse findings in nonclinical studies. Current Topics in Nonclinical Drug Development: Volume 2 will aid toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists dealing with day-to-day issues encountered in drug development and assist in formulating strategies for resolution of these issues. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
This Performance-Based Test Guideline (PBTG) describes in vitro assays, which provides the methodology of Stably Transfected Transactivation to detect Estrogen Receptor Agonists (ER TAs). It comprises mechanistically and functionally similar test ...
