TDMS Study 05187-09 Pathology Tables
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 2 YEAR CHRONIC Facility: Battelle Columbus Laboratory Chemical CAS #: 93-15-2 Lock Date: 09/17/96 Cage Range: All Reasons For Removal: 25022 Accidently Killed 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice 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: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 50 50 50 60 Early Deaths Natural Death 11 9 13 12 9 Moribund Sacrifice 17 16 14 26 25 Accidently Killed 1 Dosing Accident 1 Survivors Terminal Sacrifice 22 25 22 11 16 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (50) (50) (50) (50) Intestine Small, Duodenum (50) (50) (50) (50) (50) Leiomyosarcoma 1 (2%) Neuroendocrine Tumor, Malignant, Metastatic, Stomach, Glandular 1 (2%) Liver (50) (50) (49) (49) (50) Cholangiocarcinoma 1 (2%) Hepatocellular Carcinoma 4 (8%) 6 (12%) 13 (26%) Hepatocellular Carcinoma, Multiple 2 (4%) 9 (18%) Hepatocellular Adenoma 1 (2%) 8 (16%) 6 (12%) 10 (20%) 7 (14%) Hepatocellular Adenoma, Multiple 5 (10%) 23 (47%) 36 (72%) Hepatocholangiocarcinoma 3 (6%) 7 (14%) Hepatocholangiocarcinoma, Multiple 2 (4%) Hepatocholangioma 8 (16%) Neuroendocrine Tumor, Malignant, Metastatic, Stomach, Glandular 3 (6%) 10 (20%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Mesentery (6) (5) (3) (3) (3) Oral Mucosa (1) (1) Squamous Cell Carcinoma 1 (100%) Pancreas (50) (50) (50) (49) (50) Salivary Glands (50) (48) (49) (49) (50) Myoepithelioma 1 (2%) Stomach, Forestomach (50) (49) (50) (50) (50) Leiomyosarcoma 1 (2%) Squamous Cell Carcinoma 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) 2 (4%) Stomach, Glandular (50) (50) (50) (48) (49) Leiomyosarcoma 1 (2%) Neuroendocrine Tumor, Benign 13 (26%) 9 (19%) 5 (10%) NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Neuroendocrine Tumor, Malignant 1 (2%) 12 (24%) 26 (54%) 36 (73%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (49) (49) (50) Carcinoma, Metastatic, Uterus 1 (2%) Schwannoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Medulla (50) (50) (50) (49) (50) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 1 (2%) 1 (2%) 2 (4%) 2 (4%) 6 (12%) Islets, Pancreatic (50) (50) (50) (50) (50) Adenoma 1 (2%) Carcinoma 1 (2%) Neuroendocrine Tumor, Malignant, Metastatic, Stomach, Glandular 1 (2%) Pituitary Gland (50) (50) (50) (50) (49) Pars Distalis, Adenoma 22 (44%) 20 (40%) 21 (42%) 22 (44%) 19 (39%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (49) (49) (50) (48) C-Cell, Adenoma 2 (4%) 4 (8%) 2 (4%) 2 (4%) C-Cell, Carcinoma 1 (2%) 2 (4%) 2 (4%) 2 (4%) Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (46) (49) (46) (48) Adenoma 4 (8%) 6 (13%) 4 (8%) 3 (7%) 2 (4%) Carcinoma 1 (2%) 1 (2%) Bilateral, Adenoma 1 (2%) 2 (4%) 2 (4%) 2 (4%) Ovary (50) (50) (49) (49) (50) Carcinoma, Metastatic, Uterus 1 (2%) Granulosa Cell Tumor Malignant 2 (4%) Uterus (50) (50) (49) (50) (50) Carcinoma 1 (2%) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Polyp Stromal 4 (8%) 2 (4%) 3 (6%) 6 (12%) 10 (20%) Sarcoma Stromal 1 (2%) Vagina (2) (2) Fibrosarcoma 1 (50%) Leiomyosarcoma 1 (50%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) (50) Lymph Node (2) (5) (1) (10) (6) Mediastinal, Carcinoma, Metastatic, Uterus 1 (20%) Mediastinal, Neuroendocrine Tumor, Malignant, Metastatic, Stomach, Glandular 1 (17%) Pancreatic, Neuroendocrine Tumor, Malignant, Metastatic, Stomach, Glandular 1 (10%) Renal, Neuroendocrine Tumor, Malignant, Metastatic, Stomach, Glandular 1 (17%) Lymph Node, Mandibular (49) (48) (49) (49) (48) Lymph Node, Mesenteric (50) (49) (49) (49) (50) Spleen (50) (50) (50) (49) (50) Leiomyosarcoma 1 (2%) 1 (2%) Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Thymus (49) (48) (46) (46) (49) Thymoma Benign 1 (2%) Thymoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) (50) Adenoma 1 (2%) 1 (2%) Carcinoma 2 (4%) 3 (6%) 1 (2%) 4 (8%) Carcinoma, Multiple 1 (2%) Fibroadenoma 21 (42%) 23 (46%) 22 (44%) 22 (44%) 16 (32%) Fibroadenoma, Multiple 15 (30%) 13 (26%) 12 (24%) 9 (18%) 14 (28%) Skin (50) (50) (50) (50) (50) Basal Cell Adenoma 1 (2%) Basal Cell Carcinoma 1 (2%) Fibrosarcoma 1 (2%) Trichoepithelioma 1 (2%) Pinna, Basal Cell Adenoma 1 (2%) Pinna, Melanoma Malignant 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 2 (4%) 2 (4%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) Subcutaneous Tissue, Lipoma 1 (2%) NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Subcutaneous Tissue, Sarcoma NOS 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) Chordoma 1 (2%) Skeletal Muscle (1) (1) (1) Carcinoma, Metastatic, Uterus 1 (100%) Rhabdomyosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) Oligodendroglioma Benign 1 (2%) Oligodendroglioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (49) (49) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Uterus 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Chordoma, Metastatic, Bone 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 4 (8%) 4 (8%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) Neuroendocrine Tumor, Malignant, Metastatic, Stomach, Glandular 4 (8%) Squamous Cell Carcinoma, Metastatic, Oral Mucosa 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (3) Carcinoma 3 (100%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) (50) Transitional Epithelium, Carcinoma 1 (2%) Urinary Bladder (50) (50) (49) (50) (50) Carcinoma, Metastatic, Uterus 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) *(50) Leukemia Mononuclear 17 (34%) 20 (40%) 19 (38%) 28 (56%) 17 (34%) Mesothelioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 47 49 48 47 47 Total Primary Neoplasms 100 121 141 187 232 Total Animals with Benign Neoplasms 43 44 43 43 46 Total Benign Neoplasms 73 86 85 106 127 Total Animals with Malignant Neoplasms 22 28 26 34 39 Total Malignant Neoplasms 27 34 31 46 64 Total Animals with Metastatic Neoplasms 1 3 8 16 Total Metastatic Neoplasm 6 4 9 24 Total Animals with Malignant Neoplasms 1 Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 25 35 41 Total Uncertain Neoplasms 1 25 35 41 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 50 50 50 60 Early Deaths Natural Death 15 15 17 29 26 Moribund Sacrifice 15 18 15 20 23 Dosing Accident 1 3 1 1 Survivors Terminal Sacrifice 20 16 15 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (50) (50) (50) (49) Intestine Small, Jejunum (50) (50) (50) (50) (50) Polyp Adenomatous 1 (2%) Liver (50) (50) (50) (50) (50) Carcinoma, Metastatic, Pancreas 1 (2%) Cholangioma 2 (4%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hepatocellular Carcinoma 2 (4%) 3 (6%) 13 (26%) 14 (28%) 13 (26%) Hepatocellular Carcinoma, Multiple 1 (2%) 11 (22%) 23 (46%) Hepatocellular Adenoma 5 (10%) 7 (14%) 9 (18%) 14 (28%) 8 (16%) Hepatocellular Adenoma, Multiple 5 (10%) 14 (28%) 24 (48%) 24 (48%) Hepatocholangiocarcinoma 1 (2%) 1 (2%) 6 (12%) Hepatocholangiocarcinoma, Multiple 1 (2%) Hepatocholangioma 1 (2%) 3 (6%) Hepatocholangioma, Multiple 3 (6%) Ito Cell Tumor Benign 1 (2%) Interstitial Cell, Carcinoma, Metastatic, Testes 1 (2%) Mesentery (5) (6) (1) (1) Hepatocellular Carcinoma, Metastatic, Liver 1 (100%) Leiomyosarcoma 1 (100%) Oral Mucosa (1) Pharyngeal, Squamous Cell Papilloma 1 (100%) Pancreas (50) (50) (50) (50) (49) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (2%) Leiomyosarcoma, Metastatic, Mesentery 1 (2%) Salivary Glands (50) (50) (50) (48) (48) Schwannoma Malignant 1 (2%) Stomach, Forestomach (50) (50) (50) (50) (49) Squamous Cell Carcinoma 1 (2%) NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (50) (50) (50) (49) Neuroendocrine Tumor, Benign 3 (6%) 2 (4%) Neuroendocrine Tumor, Malignant 4 (8%) 2 (4%) Tongue (2) (1) Squamous Cell Papilloma 2 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) (49) Endocardium, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) (50) Adenoma 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Adrenal Medulla (50) (50) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) 1 (2%) 1 (2%) Pheochromocytoma Benign 18 (36%) 12 (24%) 8 (16%) 8 (16%) 9 (18%) Bilateral, Pheochromocytoma Benign 6 (12%) 5 (10%) 3 (6%) 2 (4%) Islets, Pancreatic (50) (50) (50) (50) (49) Adenoma 3 (6%) 1 (2%) Parathyroid Gland (48) (49) (48) (45) (46) Adenoma 1 (2%) 1 (2%) Pituitary Gland (50) (50) (50) (50) (50) Oligodendroglioma Malignant, Metastatic, Brain 1 (2%) Pars Distalis, Adenoma 7 (14%) 8 (16%) 8 (16%) 2 (4%) 3 (6%) Thyroid Gland (50) (50) (50) (48) (48) C-Cell, Adenoma 6 (12%) 4 (8%) 2 (4%) 3 (6%) 1 (2%) Follicular Cell, Adenoma 2 (4%) 1 (2%) 1 (2%) 1 (2%) 3 (6%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) (1) (2) (6) (2) Squamous Cell Carcinoma, Metastatic, Ureter 1 (50%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (49) (49) (50) (50) Squamous Cell Carcinoma, Metastatic, Ureter 1 (2%) Preputial Gland (50) (50) (49) (50) (50) Adenoma 8 (16%) 12 (24%) 3 (6%) 7 (14%) 4 (8%) Carcinoma 5 (10%) 1 (2%) 2 (4%) Bilateral, Adenoma 1 (2%) 4 (8%) 1 (2%) 2 (4%) Prostate (50) (50) (49) (49) (49) Carcinoma 1 (2%) Leiomyosarcoma, Metastatic, Mesentery 1 (2%) Seminal Vesicle (50) (50) (50) (50) (50) Leiomyosarcoma, Metastatic, Mesentery 1 (2%) Squamous Cell Carcinoma, Metastatic, Ureter 1 (2%) Testes (50) (49) (49) (50) (50) Squamous Cell Carcinoma, Metastatic, Ureter 1 (2%) Bilateral, Interstitial Cell, Adenoma 45 (90%) 46 (94%) 48 (98%) 46 (92%) 41 (82%) Interstitial Cell, Adenoma 1 (2%) 2 (4%) 4 (8%) 2 (4%) Interstitial Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) (50) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Lymph Node (8) (4) (4) (4) (3) Lumbar, Carcinoma, Metastatic, Preputial Gland 1 (13%) Lumbar, Fibrous Histiocytoma, Metastatic, Skin 1 (25%) Mediastinal, Carcinoma, Metastatic, Pancreas 1 (33%) Mediastinal, Fibrous Histiocytoma, Metastatic, Skin 1 (25%) Mediastinal, Hepatocellular Carcinoma, Metastatic, Liver 1 (33%) Renal, Fibrous Histiocytoma, Metastatic, Skin 1 (25%) Lymph Node, Mandibular (49) (50) (50) (48) (47) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Lymph Node, Mesenteric (50) (50) (49) (50) (48) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Spleen (50) (50) (50) (50) (49) Hemangiosarcoma 1 (2%) Leiomyosarcoma 1 (2%) Thymus (46) (45) (43) (42) (43) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (49) (49) (45) (46) Adenoma, Multiple 1 (2%) Carcinoma 1 (2%) 2 (4%) Fibroadenoma 5 (10%) 5 (10%) 10 (20%) 10 (22%) 6 (13%) Fibroadenoma, Multiple 5 (10%) 3 (7%) Skin (50) (50) (50) (50) (50) Basal Cell Carcinoma 1 (2%) Keratoacanthoma 3 (6%) 3 (6%) 4 (8%) 5 (10%) 2 (4%) Squamous Cell Papilloma 1 (2%) 1 (2%) Pinna, Melanoma Malignant 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 8 (16%) 6 (12%) 5 (10%) 4 (8%) Subcutaneous Tissue, Fibroma, Multiple 1 (2%) 2 (4%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) 2 (4%) Subcutaneous Tissue, Fibrosarcoma, Multiple 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) Subcutaneous Tissue, Hemangioma, Multiple 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) Osteosarcoma 1 (2%) Skeletal Muscle (1) Sarcoma NOS 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) Oligodendroglioma Benign 1 (2%) Oligodendroglioma Malignant 1 (2%) 1 (2%) 1 (2%) Spinal Cord (1) (1) (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (49) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Chordoma, Metastatic, Uncertain Primary Site 1 (2%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 2 (4%) 10 (20%) 22 (45%) Hepatocholangiocarcinoma, Metastatic, Liver 1 (2%) 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Squamous Cell Carcinoma, Metastatic, Ureter 1 (2%) NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Mediastinum, Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (2) (1) (1) Carcinoma 1 (100%) 2 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) (50) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Mesenchymal Tumor Benign 1 (2%) Bilateral, Renal Tubule, Adenoma 1 (2%) Renal Tubule, Adenoma 3 (6%) 2 (4%) 5 (10%) 6 (12%) 8 (16%) Renal Tubule, Carcinoma 1 (2%) Renal Tubule, Oncocytoma Benign 1 (2%) 1 (2%) Ureter (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) *(50) Leukemia Mononuclear 26 (52%) 27 (54%) 15 (30%) 13 (26%) 1 (2%) Mesothelioma Malignant 1 (2%) 3 (6%) 5 (10%) 12 (24%) 5 (10%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 12 NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC METHYLEUGENOL Date: 09/15/98 Route: GAVAGE Time: 08:06:17 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 50 48 50 46 Total Primary Neoplasms 159 180 176 212 189 Total Animals with Benign Neoplasms 49 50 48 50 46 Total Benign Neoplasms 117 134 133 147 129 Total Animals with Malignant Neoplasms 33 33 34 39 43 Total Malignant Neoplasms 42 46 43 58 56 Total Animals with Metastatic Neoplasms 3 2 4 11 25 Total Metastatic Neoplasm 3 10 4 14 38 Total Animals with Malignant Neoplasms 1 Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 7 4 Total Uncertain Neoplasms 7 4 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors 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