CONTENTS 



PAGE 



ABSTRACT 3 



EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTIVITY 7 



CONTRIBUTORS 8 



PEER REVIEW PANEL 10 



SUMMARY OF PEER REVIEW COMMENTS 11 



I. INTRODUCTION 15 



II. MATERIALS AND METHODS 23 



III. RESULTS 35 



RATS 36 



MICE 49 



IV. DISCUSSION AND CONCLUSIONS 61 



V. REFERENCES 67 



APPENDIXES 



APPENDIX A SUMMARY OF LESIONS IN MALE RATS IN THE TWO-YEAR FEED STUDY 



OF NITROFURANTOIN 77 



APPENDIX B SUMMARY OF LESIONS IN FEMALE RATS IN THE TWO-YEAR FEED STUDY 



OF NITROFURANTOIN 109 



APPENDIX C SUMMARY OF LESIONS IN MALE MICE IN THE TWO-YEAR FEED STUDY 



OF NITROFURANTOIN 137 



APPENDIX D SUMMARY OF LESIONS IN FEMALE MICE IN THE TWO YEAR FEED STUDY 



OF NITROFURANTOIN 163 



APPENDIX E GENETIC TOXICOLOGY OF NITROFURANTOIN 193 



APPENDIX F SENTINEL ANIMAL PROGRAM 201 



APPENDIX G FEED AND COMPOUND CONSUMPTION BY RATS AND MICE IN THE TWO-YEAR 



FEED STUDIES OF NITROFURANTOIN 205 



APPENDIX H INGREDIENTS, NUTRIENT COMPOSITION, AND CONTAMINANT LEVELS IN 



NIH 07 RAT AND MOUSE RATION 211 



APPENDIX I AUDIT SUMMARY 217 



Nitrofurantoin, NTP TR 341 



