LEADER 07110nam 2200769Ia 450 001 9910960101203321 005 20251017110106.0 010 $a9786610185092 010 $a9780309171397 010 $a0309171393 010 $a9781280185090 010 $a1280185090 010 $a9780309567619 010 $a0309567610 035 $a(CKB)110986584753278 035 $a(EBL)3377205 035 $a(SSID)ssj0000279270 035 $a(PQKBManifestationID)11227266 035 $a(PQKBTitleCode)TC0000279270 035 $a(PQKBWorkID)10260477 035 $a(PQKB)10422544 035 $a(MiAaPQ)EBC3377205 035 $a(Au-PeEL)EBL3377205 035 $a(CaPaEBR)ebr10068442 035 $a(CaONFJC)MIL18509 035 $a(OCoLC)923269014 035 $a(Perlego)4736076 035 $a(DNLM)1121192 035 $a(BIP)7100573 035 $a(EXLCZ)99110986584753278 100 $a20010810d2001 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aEvaluating chemical and other agent exposures for reproductive and developmental toxicity /$fSubcommittee on Reproductive and Developmental Toxicology, Committee on Toxicology, Board on Environmental Studies and Toxicology, Commission on Life Sciences, National Research Council 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$dc2001 215 $a1 online resource (262 p.) 225 1 $aCompass series 300 $aDescription based upon print version of record. 311 08$a9780309073165 311 08$a0309073162 320 $aIncludes bibliographical references (p. 92-114). 327 $a""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"" 327 $a""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"" 327 $a""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"" 327 $a""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 "" 327 $a""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"" 327 $a""Disposition and Pharmacokinetics"" 330 $aThe United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James Chen (National Center for Toxicological Research), George Daston (Procter and Gamble Company), Jerry Heindel (National Institute of Environmental Health Sciences), Grace Lemasters (University of Cincinnati), and John Young (National Center for Toxicological Research). 410 0$aCompass series (Washington, D.C.) 606 $aReproductive toxicology 606 $aDevelopmental toxicology 606 $aToxicity testing 615 0$aReproductive toxicology. 615 0$aDevelopmental toxicology. 615 0$aToxicity testing. 676 $a616.6/5071 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910960101203321 996 $aEvaluating chemical and other agent exposures for reproductive and developmental toxicity$94360225 997 $aUNINA