Intended as a tool for use by public health officials, research and regulatory scientists and risk managers, this publication seeks to provide a scientific framework for the use and interpretation of reproductive toxicity data from human and animal studies. It also discusses emerging methodology and testing strategy in reproductive toxicity. The text focuses on approaches to assessing reproductive toxicity in males and females, including sexual dysfunction and infertility, and many aspects of developmental toxicity (following both prenatal and postnatal exposure), from conception to sexual maturation. It is an overview of the major scientific principles underlying hazard identification, testing methods and risk assessment strategies in human reproductive toxicity. It also discusses the evaluation of reproductive toxicity data in the context of the extensive risk assessment methodology that has emerged over the past 10-15 years.

Conclusions, and recommendations -- Introduction and background -- Unique biological characteristics of children -- Developmental stage-specific susceptibilities and outcomes in children -- Exposure assessment of children -- Methodologies to assess health outcomes in children -- Implications and strategies for risk assessment for children.

Published under the International Programme for Chemical Safety (IPCS), a joint venture of UNEP, ILO and the WHO

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

The United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James Chen (National Center for Toxicological Research), George Daston (Procter and Gamble Company), Jerry Heindel (National Institute of Environmental Health Sciences), Grace Lemasters (University of Cincinnati), and John Young (National Center for Toxicological Research).

This is a reference for those who need to understand the fundamental toxicological concepts that underlie both the scientific development of the subject and its practical applicaton in regulation and management of chemical safety.