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용역연구개발과제 최종보고서[개인신상정보 삭제]
제출문
목차
최종보고서 요약문 5
Summary 7
총괄연구개발과제 연구결과 9
제1장 총괄연구개발과제의 최종 연구개발 목표 9
제2장 총괄연구개발과제의 최종 연구개발 내용 및 방법 12
제3장 총괄연구개발과제의 최종 연구개발 결과 28
제4장 총괄연구개발과제의 최종 연구결과 고찰 및 결론 32
제5장 총괄연구개발과제의 연구성과 34
제6장 기타 중요변경사항 36
제7장 참고문헌 37
제8장 첨부서류 39
총괄 연구과제 요약[개인신상정보 삭제] 220
8.1. F344 랫드에 대한 목단피의 2주 반복경구투여 독성시험(DRF) 39
Table 1. Mortality of F344 rats 41
Table 2. Clinical signs of F344 rats 41
Table 3. Body weights of male F344 rats 42
Table 4. Body weights of female F344 rats 43
Table 5. Urinalysis values of male F344/N rats 44
Table 6. Urinalysis values of female F344/N rats 45
Table 7. Hematological values of male F344/N rats 46
Table 8. Hematological values of female F344/N rats 47
Table 9. Blood Chemical values of male F344/N rats 48
Table 10. Blood Chemical values of female F344/N rats 49
Table 11. Absolute organ weights of F344 rats 50
Table 12. Relative organ weights of F344 rats 51
8.2. 목단피의 13주 반복경구투여 독성시험 100
Table 1. Mortality of F344 rats 102
Table 2. Clinical signs of F344 rats 102
Table 3-1. Body weights of 13 weeks oral toxicity study in male F344 rats. 103
Table 3-2. Body weights of 13 weeks oral toxicity study in female F344 rats. 103
Table 4-1. Feed consumptions of 13 weeks oral toxicity study in male F344 rats. 104
Table 4-2. Feed consumptions of 13 weeks oral toxicity study in female F344 rats. 104
Table 5-1. Water consumptions of 13 weeks oral toxicity study in male F344 rats. 105
Table 5-2. Water consumptions of 13 weeks oral toxicity study in female F344 rats. 105
Table 6-1. Urinalysis results of 13 weeks oral toxicity study in male F344 rats. 106
Table 6-2. Urinalysis results of 13 weeks oral toxicity study in female F344 rats. 106
Table 7-1. Hematological values of 13 weeks oral toxicity study in male F344 rats. 107
Table 7-2. Hematological values of 13 weeks oral toxicity study in female F344 rats. 108
Table 8-1. Blood Chemicry values of 13 weeks oral toxicity study in male F344 rats. 109
Table 8-2. Blood Chemicry values of 13 weeks oral toxicity study in female F344 rats. 110
Table 9. Necropsy findings of 13 weeks oral toxicity study in F344 rats. 111
Table 10-1. Organ weights of 13 weeks oral toxicity study in F344 rats. 114
Table 10-2. Organ weight to body weight ratio of 13 weeks oral toxicity study in F344 rats. 115
Table 11-1. Histopathological findings of 13 weeks oral toxicity study in F344 rats. 116
Table 11-2. Histopathological findings of 13 weeks oral toxicity study in female F344 rats. 118
Table 12. Sperm morphology of 13 weeks oral toxicity study in male F344 rats. 120
Table 13. Vaginal cytology of 13 weeks oral toxicity study in female F344 rats. 121
8.3. 미생물 복귀돌연변이시험 206
Table 1. Result of preliminary range-finding test 207
Table 2. Result of bacterial reverse mutation assay 208
8.4. 염색체 이상시험 211
Table 1. Result of Chromosome aberration test - Without Metabolic Activation (-S9, 6 hours) 212
Table 2. Result of Chromosome aberration test - With Metabolic Activation(-S9, 24 hours) 212
Table 3. Result of Chromosome aberration test - With Metabolic Activation(+S9, 6 hours) 213
8.5. 소핵시험 215
Table 1. Micronucleus test in ICR mice 216
Table 2. Body weights of animals 217
Appendix 1. Clinical signs of male F344 rats 52
Appendix 2. Body weights of male F344 rats 58
Appendix 3. Body weights of female F344 rats 61
Appendix 4. Urinalysis values of male F344/N rats 64
Appendix 5. Urinalysis values of female F344/N rats 70
Appendix 6. Hematological values of male F344/N rats 76
Appendix 7. Hematological values of female F344/N rats 82
Appendix 8. Blood Chemical values of male F344/N rats 88
Appendix 9. Blood Chemical values of female F344/N rats 94
Appendix 1. Clinical signs of F344 rats. 122
Appendix 1-1. Body weights of 13 weeks oral toxicity study in male F344 rats. 170
Appendix 2-1. Body weights of 13 weeks oral toxicity study in female F344 rats. 172
Appendix 3-1. Urinalysis results of 13 weeks oral toxicity study in male F344 rats. 174
Appendix 3-2. Urinalysis results of 13 weeks oral toxicity study in female F344 rats. 175
Appendix 4-1. Hematological values of 13 weeks oral toxicity study in male F344 rats. 176
Appendix 4-2. Hematological values of 13 weeks oral toxicity study in female F344 rats. 179
Appendix 5-1. Blood chemistry values of 13 weeks oral toxicity study in male F344 rats. 182
Appendix 5-2. Blood chemistry values of 13 weeks oral toxicity study in female F344 rats. 185
Appendix 6-1. Necropsy findings of 13 weeks oral toxicity study in male F344 rats. 188
Appendix 6-2. Necropsy findings of 13 weeks oral toxicity study in female F344 rats. 189
Appendix 7-1. Organ weights of 13 weeks oral toxicity study in male F344 rats. 190
Appendix 7-2. Organ weights of 13 weeks oral toxicity study in female F344 rats. 192
Appendix 8-1. Organ weight to body weight ratio of 13 weeks oral toxicity study in male F344 rats. 194
Appendix 8-2. Organ weight to body weight ratio of 13 weeks oral toxicity study in female F344 rats. 196
Appendix 9-1. Histopathological findings of 13 weeks oral toxicity study in male F344 rats. 198
Appendix 9-2. Histopathological findings of 13 weeks oral toxicity study in female F344 rats. 200
Appendix 10. Sperm morphology of 13 weeks oral toxicity study in male F344 rats. 202
Appendix 11. Vaginal cytology of 13 weeks oral toxicity study in female F344 rats. 204
Appendix 1. Result of preliminary range-finding test 209
Appendix 2. Result of bacterial reverse mutation assay 210
Appendix 1. Result of range-finding test 214
Appendix 1. Micronucleus test in ICR mice 218
Appendix 2. Body weights of animals 219
Fig. 1. Body weights of 2 weeks oral toxicity study in F344 rats. 40
Fig. 1. Body weights of 13 weeks oral toxicity study in male F344 rats. 101
Fig. 2. Body weights of 13 weeks oral toxicity study in female F344 rats. 101