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Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Toxicity, Subcommittee on Reproductive and Developmental
Otros Autores: Staff, National Research Council
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington : National Academies Press, 2001.
Colección:Compass series (Washington, D.C.)
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • EVALUATING CHEMICAL AND OTHER AGENT EXPOSURES FOR REPRODUCTIVE AND DEVELOPMENTAL TOXICITY
  • Copyright
  • Preface
  • Contents
  • Abbreviations
  • EVALUATING CHEMICAL AND OTHER AGENT EXPOSURES FOR REPRODUCTIVE AND DEVELOPMENTAL TOXICITY
  • Summary
  • CONCLUSIONS AND RECOMMENDATIONS
  • Evaluative Process
  • Assessing the Available Data
  • Integration of Toxicity and Exposure Information
  • Insufficient Data Sets
  • Application of the Evaluative Process
  • Sources of Information
  • Research Recommendations
  • 1 Introduction
  • SUBCOMMITTEE'S TASK
  • ORGANIZATION OF THE REPORT2 The Evaluative Process: Part I. Assessing the Available Data
  • PRINCIPLES AND OBJECTIVES
  • Use of Data and Judgment
  • Weight of Evidence
  • Threshold Assumption
  • Narrative Statement
  • Certainty
  • Use All Relevant, Acceptable Data
  • Qualities and Limitations of Reproductive and Developmental Toxicity Studies
  • Characterizing Data
  • Expert Review Team
  • GENERAL DESCRIPTION
  • DETAILS OF THE EVALUATIVE PROCESS
  • Exposure Data
  • General Toxicological and Biological Parameters
  • Chemistry
  • Basic Toxicity
  • Acute StudiesRepeated-Dose Studies
  • Genetic Toxicity
  • Pharmacokinetics
  • Reproductive and Developmental Toxicity
  • Human Data
  • Weighing the Evidence
  • Case Reports and Clinical Series
  • Assessing Causality in Human Studies
  • Experimental Animal Toxicity
  • Utility and Limitations
  • Adverse Effect
  • 3 The Evaluative Process: Part II. Integration of Toxicity and Exposure Information
  • INTERPRETATION OF TOXICITY DATA
  • Default Assumptions To Be Considered in Assessing Reproductive and Developmental Toxicity Risk
  • Absorption
  • Cross-Species ExtrapolationExposure Duration
  • Windows of Vulnerability
  • Additivity
  • QUANTITATIVE EVALUATION
  • Identification of the NOAEL and LOAEL
  • Calculation of the Benchmark Dose
  • Duration Adjustment
  • Uncertainty Factors
  • Calculation of the Unlikely Effect Level
  • Calculation of the Margin of Exposure (MOE)
  • Assessing a Degree of Concern
  • Application of Reproductive and Developmental Toxicity Data to Various Exposure Scenarios
  • Critical Data Needs
  • SUMMARY
  • 4 Incomplete or Insufficient Data Sets
  • PRINCIPLES TO MINIMIZE RISKPRACTICAL APPLICATION
  • REDUCING UNCERTAINTY
  • 5 Recommendations
  • GENERAL RECOMMENDATIONS
  • RESEARCH RECOMMENDATIONS
  • References
  • Appendixes
  • Appendix A Application of the Recommended Evaluative Process to Specific Chemicals
  • JP-8 JET FUEL
  • Exposure Data
  • General Toxicological and Biological Parameters
  • Lethality
  • Acute Studies
  • Human Studies
  • Experimental Animal Studies
  • Repeated-Dose Studies
  • Human Studies
  • Experimental Animal Studies
  • Cancer
  • Genetic Toxicity