Issues in Risk Assessment in Male Reproductive Toxicology

1986 ◽  
Vol 5 (4) ◽  
pp. 249-259 ◽  
Author(s):  
H. Zenick ◽  
E. D. Clegg
Keyword(s):  
Risk Assessment ◽  
Reproductive Toxicity ◽  
Response Assessment ◽  
Hazard Identification ◽  
Reproductive Systems ◽  
Reproductive Toxicology ◽  
Male And Female ◽  
Reproductive Effects ◽  
Assessment Guidelines ◽  
Effects Assessment

Efforts in the area of risk assessment have concentrated primarily on cancer as an outcome. However, attention is now being directed toward the development of strategies for assessing risk to other target systems. The Reproductive Effects Assessment Group in the Office of Health and Environmental Assessment, U.S. EPA, is involved extensively in that effort in the areas of developmental and reproductive toxicology and mutagenicity. This group is currently preparing risk assessment guidelines for the male and female reproductive systems. Some of the issues associated with hazard identification and dose-response assessment with respect to male reproductive toxicity are discussed in the present paper.

Glossary of terms used in developmental and reproductive toxicology (IUPAC Recommendations 2016)

2016 ◽  
Vol 88 (8) ◽  
pp. 713-830
Author(s):  
John H. Duffus ◽  
Michael Schwenk ◽  
Douglas M. Templeton
Keyword(s):  
Risk Assessment ◽  
Reproductive Biology ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Primary Objective ◽  
Human Reproduction ◽  
Reproductive Systems ◽  
Teratogenic Effects ◽  
Male And Female ◽  
Medical Practitioners

Abstract The primary objective of this glossary is to give clear definitions for those who contribute to studies relevant to these disciplines, or who must interpret them, but are not themselves reproductive physiologists or physicians. This applies especially to chemists who need to understand the literature of reproductive and teratogenic effects of substances without recourse to a multiplicity of other glossaries or dictionaries. The glossary includes terms related to basic and clinical reproductive biology and teratogenesis, insofar as they are necessary for a self-contained document, particularly terms related to diagnosing, measuring, and understanding the effects of substances on the embryo, the fetus, and on the male and female reproductive systems. The glossary consists of about 1200 primary alphabetical entries and includes Annexes of common abbreviations and examples of chemicals with known effects on human reproduction and development. The authors hope that toxicologists, pharmacologists, medical practitioners, risk assessors, and regulatory authorities are among the groups who will find this glossary helpful, in addition to chemists. In particular, the glossary should facilitate the worldwide use of chemical terminology in relation to occupational and environmental risk assessment.

Risk Assessment and Child Health

PEDIATRICS ◽  
2004 ◽  
Vol 113 (Supplement_3) ◽  
pp. 952-956
Author(s):  
Jonathan M. Samet
Keyword(s):  
Risk Assessment ◽  
Child Health ◽  
Population Group ◽  
Response Assessment ◽  
Current Approach ◽  
Hazard Identification ◽  
Public Health Issue ◽  
Qualitative Risk Assessment ◽  
Increased Risk ◽  
Increased Susceptibility

Risk assessment, an approach for organizing information about hazards to health, safety, and the environment, provides a framework for gauging the threat to child health from environmental pollutants. A qualitative risk assessment has 4 components: hazard identification, dose-response assessment, exposure assessment, and risk characterization. In a risk assessment, consideration can be given to a population group that potentially has increased susceptibility, whether arising from having a high level of exposure or from increased susceptibility to the agent of concern on a biological basis. Children have been proposed as being at increased risk from some environmental agents, and there has long been concern and debate that the current approach of determining acceptable exposure levels or intake for a person may not yield safe intake limits for infants and children, who may be placed at greater risk than adults because of exposure patterns and inherent susceptibility. The persistence of debate on this critical public health issue reflects, in part, the difficulty of developing sufficiently sensitive and validated animal bioassays for critical outcomes. Epidemiologic studies can play only a limited role, given the complexity of establishing cohorts and tracking exposures from conception forward to assess risks across the lifespan. Meeting society’s call for healthy environments for children poses an extraordinary challenge to researchers and to the policy makers who seek to develop evidence-based policies to protect children.

Reproductive Toxicity: Male and Female Reproductive Systems as Targets for Chemical Injury

1990 ◽  
Vol 74 (2) ◽  
pp. 391-411 ◽  
Author(s):  
Donald R. Mattison ◽  
David R. Plowchalk ◽  
M. Jane Meadows ◽  
Amer Z. Al-Juburi ◽  
Jay Gandy ◽  
...  
Keyword(s):  
Reproductive Toxicity ◽  
Reproductive Systems ◽  
Male And Female ◽  
Chemical Injury

Improving the Use of Epidemiologic Data in Health Risk Assessment

1985 ◽  
Vol 1 (4) ◽  
pp. 65-91 ◽  
Author(s):  
Linda S. Erdreich ◽  
Carol Burnett
Keyword(s):  
Risk Assessment ◽  
Risk Analysis ◽  
Health Risk ◽  
Health Risk Assessment ◽  
Statistical Power ◽  
Response Assessment ◽  
Epidemiologic Studies ◽  
Hazard Identification ◽  
Ordinal Scale ◽  
Epidemiologic Data

Epidemiologic data with quantitative exposure measures is infrequently available for specific environmental agents. This lack of exposure measures creates confusion in interpreting epidemiologic data and therefore has impeded its efficient use in health risk analysis. This paper discusses screening and evaluating epidemiologic studies for use in assessing health risk. It also describes the larger role of epidemiology in reducing uncertainties in risk analysis. The approach recognizes that the various designs used to increase statistical power and to control for covariables have different functions in contemporary risk assessment as practiced by regulatory agencies. Each of these study designs is categorized for its role in risk analysis as useful for hazard identification or for dose-response assessment. Studies presenting geographic correlations are construed to be not directly useful in health risk assessment. The numerical level of the exposure data is a deciding factor in using valid epidemiologic studies. However, data measured on an ordinal scale can be used in qualitative assessments and can demonstrate the strength of the relationship. The application of this procedure is illustrated using epidemiologic studies on the carcinogenicity of chemicals contaminated with dioxins.

Do Standard Risk Assessment Procedures Adequately Account for Cumulative Risks?

2009 ◽  
Vol 29 (1) ◽  
pp. 65-70 ◽  
Author(s):  
Andrew G. Salmon
Keyword(s):  
Risk Assessment ◽  
Cumulative Risk ◽  
Response Assessment ◽  
Hazard Identification ◽  
Integrated Analysis ◽  
Multiple Agents ◽  
Multiple Sources ◽  
Dose Rates ◽  
Cumulative Risks ◽  
Assessment Procedures

Existing risk assessment data and procedures can be used to address the estimation of cumulative risk, but there are several uncertainties. These are explored in the context of the State of California’s Air Toxic Hot Spots program. Hazard identification for single agents is an established procedure but is much more complex for incompletely characterized or variable mixtures. Hazards from exposure to multiple agents are often only identified by chance. Similar concerns affect dose-response assessment. Although additivity is assumed by default for similar effects at low doses, exceptions are known for specific mixtures and for higher dose rates. Exposure assessment is especially complex for multiple sources, multiple agents from different sources, and target populations or individuals who face cumulative, but not necessarily simultaneous, impacts. With these contributory uncertainties, providing an integrated analysis that can inform risk management and presenting this to a diverse and often already stressed community are challenging.

scholarly journals Application of Physiologically Based Pharmacokinetic Models in Chemical Risk Assessment

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Moiz Mumtaz ◽  
Jeffrey Fisher ◽  
Benjamin Blount ◽  
Patricia Ruiz
Keyword(s):  
Risk Assessment ◽  
Response Assessment ◽  
Field Application ◽  
Hazard Identification ◽  
Chemical Risk Assessment ◽  
Pbpk Models ◽  
Physiologically Based Pharmacokinetic ◽  
Physiologically Based ◽  
Cooperative Agreements ◽  
User Friendly

Post-exposure risk assessment of chemical and environmental stressors is a public health challenge. Linking exposure to health outcomes is a 4-step process: exposure assessment, hazard identification, dose response assessment, and risk characterization. This process is increasingly adopting “in silico” tools such as physiologically based pharmacokinetic (PBPK) models to fine-tune exposure assessments and determine internal doses in target organs/tissues. Many excellent PBPK models have been developed. But most, because of their scientific sophistication, have found limited field application—health assessors rarely use them. Over the years, government agencies, stakeholders/partners, and the scientific community have attempted to use these models or their underlying principles in combination with other practical procedures. During the past two decades, through cooperative agreements and contracts at several research and higher education institutions, ATSDR funded translational research has encouraged the use of various types of models. Such collaborative efforts have led to the development and use of transparent and user-friendly models. The “human PBPK model toolkit” is one such project. While not necessarily state of the art, this toolkit is sufficiently accurate for screening purposes. Highlighted in this paper are some selected examples of environmental and occupational exposure assessments of chemicals and their mixtures.

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