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PART 1: TOXICITY-TESTING NEEDS IN THE SELECT UNIVERSE
Pages 23-28

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From page 23...
... OPERATING POLICIES FOR IDENTIFICATION, ACQUISITION, AND ORGANIZATION OF DATA Restricted-Access or Confidential Information Information on Toxicity in Humans Chemical and Physical Characteristics, Manufacturing Processes, Production Volumes, Intended Uses, and Exposure of Humans Chemical Review Articles Articles in Foreign Languages Substances Structurally Similar to Those in the Sample 4. DATA EVALUATION The Dossier Concept General Principles for Evaluation of Toxicity-Testing Protocols Consideration of Exposure Purity of Selected Substances Guidelines for Assessing the Quality of Individual Studies Basic Criteria for Scientific Methods 23 Page 29 33 33 38 38 38 39 39 42 43 43 45 45 51 51 53 53 54 54 54 55 55 56 57 60 61 61
From page 24...
... Selection of Reference Protocols Reference Protocol Guidelines for Neurobehavioral-Toxicity Tests Reference Protocol Guidelines for GeneticTaxicity Tests Procedures for Evaluation of the Data Base Initial Considerations Adequacy Ratings Measures of Adequacy for Tests Not Meeting the Reference Protocol Guidelines Dossier Review Process Limitations of the Data Gathering Process Interpretation of Data on Testing Quality Characterizing the Sample and Options for Drawing Inferences to the Select Universe Construction of Tables for Analysis Statistical Analysis of Data Estimates Based on the Sample Alone Estimates Based on the Subsample alone Estimates Based on Both the Sample and the Subsample Machine-Readable Files 5. RESULTS Quantity and Nature of Testing Sample of 675 Substances Subsample of 100 Substances Quality of Testing Testing Needs Health-Hazard Assessment Interpretation and Analysis of Physicochemical and Exposure Data 6.
From page 25...
... Committee Format for Recording Judgments about Protocol of Toxicity Study 7. Estimated Percentages of Substances in Seven Categories of Select Universe That Have Five Basic Tests Used in Screen for Prescribed Minimal Toxicity Information 8.
From page 26...
... Relative Comparison of Testing Need by Intended-Use Category of Select Universe 20. Ability to Conduct Health-Hazard Assessment of 100 102 104 106 108 110 112 114 Substances in Seven Categories of Select Universe 117 21.
From page 27...
... Steps in process of evaluating adequacy of toxicity testing for substances Outline of procedure for decision-making in evaluating adequacy of toxicity information on specific substance 4. Ability to conduct health-hazard assessment of substances in seven categories of select universe 27 Page 37 52 58 118
From page 28...
... Page Appendix A Sample of 675 Substances and Subsample of 100 Substances from the "Select Universe" 129 Appendix B Testing for Various Situations of Chemical Use and General Exposure to Direct and Indirect Food Additives Appendix C Testing for Various Situations of Chemical Use and General Exposure to Oral or Parenteral Drugs or Color Additives for Sutures Appendix D Testing for Various Situations of Chemical Use and General Exposure to Inhalation and Veterinary Drugs Appendix E Testing for Various Situations of Chemical Use and General Exposure to Cosmetics and Dermal, Vaginal-Rectal, Over-the-Counter, and Ophthalmic Drugs 151 153 155 157 Appendix F Testing for Various Situations of Chemical Use and General Exposure to Pesticides 159 Appendix G Testing for Various Situations of Chemical Use and General Exposure to Other Marketable Chemicals 161 Appendix H Reference Protocols for Toxicity Testing 165 Appendix I Reference Protocol Guidelines for Neurobehavioral-Ioxicity Tests 169 Appendix J Reference Protocol Guidelines for Genetic-Ioxicity Tests 175 Appendix K Conceptual Issues Concerning the Interpretation of Results of Studies of Reproductive and Developmental Toxicity 177 Appendix L Major Components of a Dossier Appendix M Procedures, Rationale, and Results of Data Identification and Acquisition 28 179 185


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