51st Annual Meeting & ToxExpo - Society of Toxicology

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Society of Toxicology 2012 Scientific Workshops The Thematic Track information can be found on pages 8–9. Monday Alternative Approaches to the Safety Assessment of Natural Ingredients and Extracts in Cosmetics Monday, March 12, 9:15 AM to 12:00 Noon Chairperson(s): Vinayak Srinivasan, L‘Oréal, Clark, NJ, and Julie Skare, Procter & Gamble, Cincinnati, OH. Sponsor: Association of Scientists of Indian Origin Special Interest Group Endorsed by: Food Safety Specialty Section In Vitro and Alternative Methods Specialty Section Regulatory and Safety Evaluation Specialty Section Risk Assessment Specialty Section Today, there is a growing consumer demand for naturally-derived ingredients and botanical extracts such as those used as food or as flavoring agents and those in personal care products. The principles used in safety evaluation of foods can be extrapolated to cosmetic ingredients where the primary route of application is dermal versus the oral route. While quality standards exist for certification of organic and natural cosmetics, there are no globally accepted safety assessment standards for these products. Although relatively rare, adverse reactions to cosmetic and personal care products containing traditional synthetic chemicals as well as botanical ingredients have been documented in the literature. The safety assessment of plant materials for which no or only a limited record of human exposure can be established is complex, given that traditional, standard safety testing methods for synthetic chemicals cannot be applied to natural plant ingredients for various reasons. Therefore, chemical grouping, comparative, and read-across approaches as well as the concept of the Threshold of Toxicological Concern (TTC) and other in silico based animal alternative methodologies are pragmatic, logical, and reliable tools for the safety assessment of plant-derived cosmetic ingredients. • Application of the Threshold of Toxicological Concern (TTC) to the Safety Evaluation of Cosmetic Ingredients. Corrado Galli, University of Milan, Milan, Italy. • Assessment of Naturally Occurring Mixtures. Tim Adams, Flavor and Extract Manufacturers Association, Washington, DC. • Use of Threshold of Toxicological Concern at the FDA. Diego Rua, Office of Cosmetics and Colors, US FDA, Washington, DC. • Regulatory Use of Computational Toxicology Tools and Databases at the FDA. Kirk Arvidson, Office of Food Additive Safety, US FDA, Washington, DC. • Application of In Silico Approaches in Cosmetics—Juniper Berry Oil. Tom Re, L‘Oréal, Clark, NJ. Regulatory Science: Bridging the Gap between Discovery and Product Availability High-Throughput In Vitro Toxicity Testing: A Midcourse Assessment of Predictive Accuracy for In Vivo Endpoints and Use in Decision-Making Monday, March 12, 9:15 AM to 12:00 Noon Chairperson(s): Russell S. Thomas, The Hamner Institutes for Health Sciences, Research Triangle Park, NC, and William D. Pennie, Pfizer, Inc., Groton, CT. Sponsor: In Vitro and Alternative Methods Specialty Section Endorsed by: Drug Discovery Toxicology Specialty Section Molecular Biology Specialty Section Regulatory Safety Evaluation Specialty Section Over the past five years there has been a broad-based discussion on the future direction of toxicology and how safety testing is performed. This discussion has spawned multiple research efforts looking to use high- and medium-throughput in vitro screening data in identifying chemical hazards. For industrial and agricultural chemicals, research efforts in United States and Europe have characterized the in vitro biological activity of chemicals using multiple in vitro assays and technologies in order to predict in vivo toxicity and prioritize compounds for conventional toxicity testing. For pharmaceuticals, high-throughput in vitro screening assays have been integrated early into preclinical drug development to identify toxic compounds and guide medicinal chemistry efforts. In both cases, the application of in vitro toxicity screening for prioritization and hazard identification relies on its ability to accurately predict the results of in vivo laboratory animal studies and humans. The efforts in the United States and Europe are now several years old and a significant amount of data has been collected to provide an evaluation of the strengths and limitations of the using high- and medium-throughput screening for predicting in vivo apical responses. This session will be of broad interest to investigators and regulators looking to use in vitro assays for toxicological testing and safety assessment of environmental, industrial, and pharmaceutical chemicals. • A Comprehensive Statistical Analysis of the In Vitro to In Vivo Predictive Capacity of High-Throughput Toxicity Screens. Russell Wolfinger, SAS Institute, Inc., Cary, NC. • Feasibility of Predicting In Vivo Mode of Action Using Pathway Based In Vitro Screens. Richard Judson, US EPA, Research Triangle Park, NC. Thematic Session 86 SOT’s 51 st Annual Meeting
51 st Annual Meeting and ToxExpo The Thematic Track information can be found on pages 8–9. Workshops Scientific • Evaluating the Effect of Dosimetry on the In Vitro to In Vivo Predictive Capacity and Relative Sensitivity of the ToxCast Screens. Barbara Wetmore, The Hamner Institutes for Health Sciences, Research Triangle Park, NC. • Predicting In Vivo Toxicity Using In Vitro Assays and Chemical Properties in Preclinical Drug Development. William D. Pennie, Pfizer, Inc., Groton, CT. • Using In Vitro Models to Predict Reproductive and Developmental Toxicity: A Midcourse Assessment of the European ReProTect Program. Michael Schwarz, University of Tuebingen, Tuebingen. Characterizing Toxic Modes of Action and Pathways to Toxicity The Epididymis—The Forgotten Target of Toxicants Monday, March 12, 9:15 AM to 12:00 Noon Chairperson(s): Daniel G. Cyr, INRS-Institut Armand-Frappier, Laval, Québec, Canada, and Robert E. Chapin, Pfizer, Inc., Groton, CT. Sponsor: Reproductive and Developmental Toxicology Specialty Section Endorsed by: Toxicologic and Exploratory Pathology Specialty Section The epididymis is the major component of the testicular excurrent duct system. Testicular input to the tissue is conveyed via the efferent ducts, which anastomose to form a single, highly convoluted epididymal duct. The epididymis can be divided into two main compartments: the epithelium and the lumen. In adults, the lumen contains sperm that are bathed in luminal fluid whose composition varies markedly along the tissue. The blood-epididymis barrier, formed by epithelial principal cells, regulates this luminal environment and distinguishes it from blood. Functional sperm maturation in the epididymis is the result of their exposure to the luminal environment. Thus, the ability of the epididymis to provide the appropriate milieu for sperm maturation is critical. This is created by several processes, most notably the highly absorptive and secretory activities of the epithelial cells that line the duct. Many epididymal functions are either androgen or estrogen-dependent. The critical functions of the epididymis for sperm maturation and its reliance on hormonal regulation make it a prime target for toxic action. Several studies have shown that endocrine-disrupting chemicals, such as phthalates, can alter the development of the epididymis, and, in extreme cases, lead to its absence. Other chemicals, such as dioxins, affect sperm maturation via alterations to epididymal functions. However, epididymal function is frequently ignored in toxicity studies. Yet, posttesticular and idiopathic male infertility represents a significant problem, suggesting that alterations in epididymal sperm maturation may have greater significance than previously thought. This session will provide an overview of epididymal functions and regulation and show examples of how environmental toxicants may alter male fertility by targeting the epididymis. • The Epididymis: Overview of Functions and Role of Basal Cells in Protection against Free Radicals. Louis Hermo, McGill University, Montréal, Québec, Canada. • The Effects of Antiandrogens on Epididymal Development in the Rat. Paul Foster, National Toxicology Program, Research Triangle Park, NC. • The Blood-Epididymis Barrier: A Critical Component of Both Detoxification and Sperm Maturation. Daniel G. Cyr, INRS- Institut Armand-Frappier, Laval, Québec, Canada. • The Epididymis As a Target Organ for Toxicants. Wilma Kempinas, Universidade Estadual Paulista, Botucatu, São Paulo, Brazil. • Chemical-Induced Inflammation and Granulomas in the Epididymis. Robert E. Chapin, Pfizer Inc., Groton, CT. Therapeutic Immunomodulation and Cancer Risk: Science, Risk Assessment, and Risk Communication Monday, March 12, 9:15 AM to 12:00 Noon Chairperson(s): Marc Pallardy, Université Paris-Sud—INSERM, Chatenay-Malabry, France, and Shawn Heidel, Eli Lilly and Company, Indianapolis, IN. Sponsor: Immunotoxicology Specialty Section Endorsed by: Biotechnology Specialty Section Therapeutic immunomodulators have evolved from broad-spectrum immune system antagonists used in the treatment of organ transplantation to newly emerging targeted therapeutics treating specific immune-mediated diseases. Whereas broad-acting agents have been implicated with increased cancer risk in chronically-treated patients, the risks associated with targeted immunotherapies can be anticipated to be driven by their mechanism of action. This session will discuss current paradigms around immunomodulation and cancer, available tools for the assessment of cancer risk applied to therapeutic immunomodulators, risk assessment, and views from industry and regulators. The discussions in this presentation coincide with recent international regulatory and industry efforts to update ICH S6(R1), which guides the nonclinical development of large molecule therapeutics. • Immunomodulation and Cancer: An Overview. Rafael Ponce, Amgen, Inc., Seattle, WA. up-to-date information at www.toxicology.org 87 Thematic Session
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