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
Notes
""Disposition and Pharmacokinetics""
Bibliography
Includes bibliographical references (pages 92-114)
