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Validation of Two Neutral Red Uptake Test Methods for Determining Starting Doses for Acute Oral Toxicity Tests
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Draft Background Review Document: March 17, 2006

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In Vitro Acute Toxicity Methods Draft Background Review Document (BRD)

Sections 1 - 13
March 17, 2006

Note: This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by NIH. It does not represent and should not be construed to represent any NIH determination or policy.



Table of Contents
 Executive Summary

  1. INTRODUCTION AND RATIONALE FOR THE USE OF IN VITRO NEUTRAL RED UPTAKE CYTOTOXICITY TEST METHODS TO PREDICT STARTING DOSES FOR IN VIVO ACUTE ORAL TOXICITY TESTING [PDF or Word]

  2. TEST METHOD PROTOCOL COMPONENTS OF THE 3T3 AND NHK IN VITRO NRU TEST METHODS [PDF or Word]

  3. REFERENCE SUBSTANCES USED FOR VALIDATION OF THE 3T3 AND NHK NRU TEST METHODS PDF or Word]

  4. RODENT ACUTE ORAL LD50 REFERENCE VALUES USED TO ASSESS THE ACCURACY OF THE 3T3 AND NHK NRU TEST METHODS [PDF or Word]

  5. 3T3 AND NHK METHOD DATA AND RESULTS [PDF or Word]

  6. ACCURACY OF THE 3T3 AND NHK METHODS [PDF or Word]

  7. RELIABILITY OF THE 3T3 AND NHK TEST METHODS [PDF or Word]

  8. 3T3 AND NHK NRU TEST METHOD DATA QUALITY 0 [PDF or Word]

  9. OTHER SCIENTIFIC REPORTS AND REVIEWS OF IN VITRO CYTOTOXICITY TEST METHODS AND THEIR ABILITY TO PREDICT IN VIVO ACUTE TOXICITY AND OTHER TOXIC EFFECTS [PDF or Word]

  10. ANIMAL WELFARE CONSIDERATIONS (REFINEMENT, REDUCTION, AND REPLACEMENT) [PDF or Word]

  11. PRACTICAL CONSIDERATIONS [PDF or Word]

  12. REFERENCES [PDF or Word]

  13. GLOSSARY [PDF or Word]

  14. APPENDICES [HTML]
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