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 REPORT -- 2 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 Studies -- Repeated-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 Extrapolation -- Exposure 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 RISK -- PRACTICAL 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 -- Disposition and Pharmacokinetics -- Reproductive and Developmental Toxicity Data -- Human Studies -- Experimental Animal Studies -- Developmental Toxicity -- Reproductive Toxicity -- Integration of Toxicity and Exposure Information -- Interpretation of Toxicity Data -- Quantitative Evaluation -- Critical Data Needs -- Summary -- Human Exposure -- Toxicology -- Developmental Toxicity -- Reproductive Toxicity -- Quantitative Evaluation -- Developmental Toxicity -- Reproductive Toxicity -- Certainty of Judgment and Data Needs -- 1,1,1,2-TETRAFLUOROETHANE1 -- Exposure Data -- General Toxicological and Biological Parameters -- Acute Studies -- Repeated-Dose Studies -- Genetic Toxicity Studies -- Carcinogenicity Studies -- Other Toxicity -- Pharmacokinetics -- Reproductive and Developmental Toxicity Data -- Human Studies -- Experimental Animal Studies -- Reproductive Toxicity -- Developmental Toxicity Studies -- Integration of Toxicity and Exposure Information -- Interpretation of Toxicity Data.

General Toxicity and Pharmacokinetics -- Reproductive and Developmental Toxicity -- Default Assumptions -- Quantitative Evaluation -- Critical Data Needs -- Summary -- Human Exposure -- Toxicology -- Developmental Toxicity -- Reproductive Toxicity -- Quantitative Evaluation -- Reproductive and Developmental Toxicity -- Certainty of Judgment and Data Needs -- Appendix B Ascertaining Information on the Reproductive and Developmental Toxicity of Agent Exposures -- SOURCES OF INFORMATION SPECIFIC TO REPRODUCTIVE AND DEVELOPMENTAL TOXICITY -- Detailed Evaluations -- California Environmental Protection Agency Hazard Identification Documents on Reproductive and Devel... -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures that Pose a Substantial Risk of Reproductive or Developmental To... -- Evaluative Process (Moore et al. 1995a,b -- 1997) -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive and Developmental T ... -- National Institute of Environmental Health Sciences Center for the Evaluation of Risks to Human Repr... -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- Informational Summaries -- Reproductive Hazards of Industrial Chemicals: An Evaluation of Animal and Human Data -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- REPROTEXT -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To...

REPROTOX -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- Chemically Induced Birth Defects -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- Shepard's Catalog of Teratogenic Agents -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- TERIS -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- Bibliographic Resources -- Developmental and Reproductive Toxicology Data Base -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- Environmental Teratology Information Center Backfile -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive and Developmental... -- Primary Data -- National Toxicology Program Teratology Studies -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive and Developmental... -- NTP Reproductive Assessment by Continuous Breeding Studies -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive and Developmental...

NTP Short-Term Developmental and Reproductive Toxicity Studies -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive and Developmental... -- ADDITIONAL SOURCES THAT MAY INCLUDE INFORMATION ON REPRODUCTIVE AND DEVELOPMENTAL TOXICITY -- Detailed Evaluations -- Agency for Toxic Substances and Disease Registry Toxicological Profiles -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- National Institute for Occupational Safety and Health Criteria Documents -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- International Agency for Research on Cancer Monographs on the Evaluation of Carcinogenic Risks to Humans -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- International Programme on Chemical Safety Environmental Health Criteria Documents -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- EPA Integrated Risk Information System -- Description -- Reproductive and Developmental Toxicity -- Quality Control -- Usefulness in Identifying Exposures That Pose a Substantial Risk of Reproductive or Developmental To... -- EPA National Center for Environmental Assessment Documents -- Description -- Reproductive and Developmental Toxicity -- Quality Control.

Usefulness in Identifying Exposures that Pose a Substantial Risk of Reproductive and Developmental T...