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The Center for the Evaluation of Risks to Human Reproduction (CERHR) conducted an evaluation of the potential for Bisphenol A to cause adverse effects on reproduction and development in humans. Bisphenol A is a high production volume chemical used primarily in the production of polycarbonate plastics and epoxy resins, both of which are used in some food and drink containers. CERHR selected it for evaluation because of the: Widespread human exposure; Public concern for possible health effects from human exposures; High production volume; and Evidence of reproductive and developmental toxicity in laboratory animal studies. This monograph includes a Brief on Bisphenol A and the Expert Panel Report on Bisphenol A. Charts and tables.
Bisphenol A (BPA) is used to produce certain types of plastic that are used in thousands of formulations for myriad products. Containers made with these plastics may expose people to small amounts of BPA in food and water. Medical devices and other more ubiquitous products, such as thermal paper coatings, also may contribute significantly to human exposure. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA. Contents of this report: Health Effects; Human Exposure; Fed. BPA Regulations; Events Surrounding the Current Controversy: Nat. Toxicology Program; FDA; State Gov¿t. Actions; Foreign Gov¿t. Actions; Private Sector Actions. A print on demand report.
Our world and bodies are becoming increasingly polluted with chemicals capable of interfering with our hormones and thus, possibly, our present and future neural and mental health. As authors Heather Patisaul and Scott Belcher outline, there is a large lack of data and evidence in this causal relationship, which begs a need for further study to accelerate progress in the endocrinology and neuroendocrinology fields. Endocrine Disruptors, Brain, and Behavior focuses on if and how these chemicals, known as endocrine disrupting compounds (EDCs), affect the development and function of the brain and might be contributing to neural disorders rapidly rising in prevalence. The book provides an overall synthesis of the EDC field, including its historical roots, major hypotheses, key findings, and research gaps. The authors explain why even the concept of endocrine disruption is controversial in some circles, how differing definitions of endocrine disruption and what constitutes an "adverse" outcome on the brain shape public policy, and where the current capacity by different stakeholders (industry, academia, regulatory agencies) to evaluate chemicals for safety in a regulatory context begins and ends. The book concludes with suggestions for future research needs and a summary of emerging technology which might prove capable of more effectively evaluating existing and emerging chemicals for endocrine disrupting properties. As such, it provides the context for interdisciplinary and innovative input from a broad spectrum of fields, including those well-schooled in neuroscience, evolutionary biology, brain, behavior, sex differences, and neuroendocrinology.
Though overall cancer incidence and mortality have continued to decline in recent years, cancer continues to devastate the lives of far too many Americans. In 2009 alone, 1.5 million American men, women, and children were diagnosed with cancer, and 562,000 died from the disease. There is a growing body of evidence linking environmental exposures to cancer. The Pres. Cancer Panel dedicated its 2008¿2009 activities to examining the impact of environmental factors on cancer risk. The Panel considered industrial, occupational, and agricultural exposures as well as exposures related to medical practice, military activities, modern lifestyles, and natural sources. This report presents the Panel¿s recommend. to mitigate or eliminate these barriers. Illus.
Bioenvironmental Issues Affecting Men's Reproductive and Sexual Health is structured into two parts related to men's reproductive and sexual health with eight sections designed to enable a logical flow of such knowledge. The book is focused on the biology of key organs involved in male reproduction and the environmental influences affecting their functions with particular emphasis on clinical aspects. Individual chapters within the book range from basic to translational aspects, but all hold clinical relevance. This is an essential reference for those working and learning in the field of human reproduction, reproductive toxicology and environmental influences on reproductive and sexual health. - Brings together the leading authorities working in the field of male reproduction and sexual health and how the environment affects these issues - Provides guidelines and reference values of various reproductive hormones, semen parameters, inclusion/exclusion criteria for clinical trials - Discover the most efficient methods by which to design clinical protocols for sperm safety studies and reproductive toxicology trials
Germ cells have a unique and critical role as the conduit for hereditary information. The issue of male germline mutagenesis and the effects on developmental defects in the next generation has become increasingly high profile in recent years. Understanding the mechanisms by which the germline is induced and maintained is one of the effective ways to treat infertility and cancer. Male-mediated Developmental Toxicity discusses these issues and provides analysis of the fundamental mechanisms of mutations covering both clinical and experimental aspects. It helps clarify the data explaining how genotoxicity involves multiple modes of action and highlights novel models and assays being used to assess germ cell genotoxicity. With a clear focus on the various mechanisms that could impact human health, this book is for postgraduate students and researchers in reproductive and developmental toxicology as well as those with an interest in the fields of genetically inherited diseases, developmental biology and, potentially, those with a more clinical background.
Reproductive toxicology is a complex subject dealing with three components—parent, placenta, and fetus—and the continuous changes that occur in each. Reproductive and Developmental Toxicology is a comprehensive and authoritative resource providing the latest literature enriched with relevant references describing every aspect of this area of science. It addresses a broad range of topics including nanoparticles and radiation, gases and solvents, smoking, alcohol and drugs of abuse, food additives, nutraceuticals and pharmaceuticals, and metals, among others. With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages, and is the only resource to include reproductive and developmental toxicity in domestic animals, fish, and wildlife. - Provides a complete, integrated source of information on the key risk stages during reproduction and development - Includes coverage of emerging science such as stem cell application, toxicoproteomics, metabolomics, phthalates, infertility, teratogenicity, endocrine disruption, surveillance and regulatory considerations, and risk assessment - 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
While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.