NTP Experiment-Test: 20005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 90-DAY GINSENG Date: 08/24/04 Route: GAVAGE Time: 09:21:19 FINAL #1 RATS Facility: Battelle Columbus Laboratory Chemical CAS #: 50647-08-0 Lock Date: 10/28/03 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 20005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 90-DAY GINSENG Date: 08/24/04 Route: GAVAGE Time: 09:21:19 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 1000 2000 3000 4000 5000 MG/KG MG/KG MG/KG MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 10 10 10 10 10 10 Early Deaths Survivors Terminal Sacrifice 10 10 10 10 10 10 Animals Examined Microscopically 10 3 1 3 2 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (10) (1) (10) Periesophageal Tissue, Hemorrhage 1 (100%) Liver (10) (1) (1) (2) (1) (10) Fibrosis, Focal 1 (100%) Hepatodiaphragmatic Nodule 1 (10%) 1 (100%) 1 (100%) 2 (100%) 1 (100%) 1 (10%) Inflammation, Chronic Active 7 (70%) 1 (100%) 10 (100%) Inflammation, Granulomatous 1 (10%) Necrosis, Focal 1 (100%) Pancreas (10) (10) Atrophy 1 (10%) Infiltration Cellular, Mononuclear Cell 5 (50%) 4 (40%) Inflammation 1 (10%) Stomach, Forestomach (10) (10) Epithelium, Hyperplasia, Squamous 1 (10%) Stomach, Glandular (10) (10) Infiltration Cellular, Mononuclear Cell 6 (60%) 2 (20%) Epithelium, Inflammation, Granulomatous 1 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (10) (10) Inflammation, Chronic 1 (10%) Adventitia, Pigmentation, Hemosiderin 1 (10%) Heart (10) (10) Cardiomyopathy 7 (70%) 7 (70%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Thyroid Gland (10) (10) Degeneration 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 20005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 90-DAY GINSENG Date: 08/24/04 Route: GAVAGE Time: 09:21:19 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 1000 2000 3000 4000 5000 MG/KG MG/KG MG/KG MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Inflammation, Chronic Active 1 (10%) Pigmentation, Hemosiderin 1 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (10) (2) (1) (1) (10) Cyst 1 (100%) Uterus (10) (1) (10) Endometrium, Hyperplasia, Cystic 1 (100%) 2 (20%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (1) Deep Cervical, Hyperplasia, Lymphoid 1 (100%) Lymph Node, Mesenteric (10) (10) Pigmentation, Hemosiderin 1 (10%) 1 (10%) Spleen (10) (10) Hematopoietic Cell Proliferation 9 (90%) 9 (90%) Pigmentation, Hemosiderin 9 (90%) 9 (90%) Thymus (10) (10) Atrophy 1 (10%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 20005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 90-DAY GINSENG Date: 08/24/04 Route: GAVAGE Time: 09:21:19 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 1000 2000 3000 4000 5000 MG/KG MG/KG MG/KG MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) Inflammation, Chronic Active 8 (80%) 8 (80%) Bronchiole, Hyperplasia 1 (10%) Nose (10) (10) Cyst 1 (10%) Olfactory Epithelium, Inflammation 1 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (10) (10) Sclera, Inflammation, Chronic Active 1 (10%) Harderian Gland (10) (10) Infiltration Cellular, Mononuclear Cell 1 (10%) 1 (10%) Inflammation, Suppurative 3 (30%) 7 (70%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) Mineralization 7 (70%) 9 (90%) Nephropathy 2 (20%) 3 (30%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 20005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 90-DAY GINSENG Date: 08/24/04 Route: GAVAGE Time: 09:21:19 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 1000 2000 3000 4000 5000 MG/KG MG/KG MG/KG MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 10 10 10 10 10 10 Early Deaths Survivors Terminal Sacrifice 10 10 10 10 10 10 Animals Examined Microscopically 10 1 2 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Liver (10) (1) (2) (10) Hematopoietic Cell Proliferation 1 (10%) 1 (50%) 2 (20%) Hepatodiaphragmatic Nodule 1 (10%) 1 (100%) 2 (100%) Inflammation, Chronic Active 9 (90%) 1 (100%) 8 (80%) Inflammation, Chronic Active, Focal 1 (10%) Bile Duct, Hyperplasia 1 (10%) Pancreas (10) (10) Atrophy 1 (10%) Infiltration Cellular, Mononuclear Cell 4 (40%) 5 (50%) Inflammation 1 (10%) 1 (10%) Stomach, Glandular (10) (10) Infiltration Cellular, Mononuclear Cell 6 (60%) 7 (70%) Inflammation 1 (10%) Glands, Ectasia 2 (20%) 3 (30%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (10) (10) Inflammation 1 (10%) Heart (10) (10) Cardiomyopathy 10 (100%) 10 (100%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM None ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 20005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 90-DAY GINSENG Date: 08/24/04 Route: GAVAGE Time: 09:21:19 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 1000 2000 3000 4000 5000 MG/KG MG/KG MG/KG MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (10) (10) Atrophy 1 (10%) Inflammation 1 (10%) Prostate (10) (10) Atrophy 1 (10%) Inflammation 1 (10%) Seminal Vesicle (10) (10) Atrophy 1 (10%) Testes (10) (10) Inflammation 1 (10%) Germinal Epithelium, Degeneration 1 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Spleen (10) (10) Hematopoietic Cell Proliferation 10 (100%) 10 (100%) Pigmentation, Hemosiderin 2 (20%) 2 (20%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) Inflammation, Chronic Active 8 (80%) 10 (100%) Nose (10) (10) Respiratory Epithelium, Inflammation 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 20005-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 90-DAY GINSENG Date: 08/24/04 Route: GAVAGE Time: 09:21:19 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 1000 2000 3000 4000 5000 MG/KG MG/KG MG/KG MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (10) (10) Infiltration Cellular, Mononuclear Cell 1 (10%) Inflammation, Suppurative 6 (60%) 3 (30%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) Mineralization 5 (50%) 7 (70%) Nephropathy 8 (80%) 9 (90%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------