TDMS Study 05142-03 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) T-BUTYL ALCOHOL NTP Experiment-Test: 05142-03 Report: PEIRPT05 Study Type: CHRONIC Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 Facility: Southern Research Institute Chemical CAS #: 75-65-0 Lock Date: 01/10/92 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: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 7 8 7 3 Moribund Sacrifice 15 18 21 35 Survivors Terminal Sacrifice 28 24 22 12 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (60) (60) (59) (60) Intestine Small, Jejunum (60) (59) (59) (60) Adenoma 1 (2%) Liver (60) (60) (60) (60) Fibrosarcoma 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) 1 (2%) Mesentery (9) (6) (8) (6) Carcinoma, Metastatic, Uterus 1 (13%) Sarcoma Stromal, Metastatic, Uterus 1 (13%) Pancreas (60) (60) (59) (60) Carcinoma, Metastatic, Uterus 1 (2%) Pharynx (1) Squamous Cell Papilloma 1 (100%) Salivary Glands (60) (60) (60) (60) Stomach, Forestomach (60) (60) (60) (60) Stomach, Glandular (60) (60) (60) (60) Carcinoid Tumor Benign 1 (2%) Tongue (1) (1) (3) Squamous Cell Carcinoma 1 (100%) Squamous Cell Papilloma 1 (100%) 1 (33%) Tooth (2) Gingiva, Squamous Cell Carcinoma 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Adenoma 1 (2%) 1 (2%) 1 (2%) Adrenal Medulla (60) (60) (60) (59) Pheochromocytoma Malignant 1 (2%) 1 (2%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 3 (5%) 1 (2%) 2 (3%) Islets, Pancreatic (60) (60) (58) (60) Adenoma 1 (2%) 1 (2%) 4 (7%) 1 (2%) Carcinoma 1 (2%) Pituitary Gland (60) (60) (59) (59) Pars Distalis, Adenoma 33 (55%) 32 (53%) 28 (47%) 30 (51%) Pars Distalis, Carcinoma 2 (3%) 1 (2%) 1 (2%) 1 (2%) Pars Intermedia, Adenoma 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (59) (60) (60) (60) C-Cell, Adenoma 8 (14%) 4 (7%) 6 (10%) 9 (15%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (59) (60) (60) (60) Adenoma 4 (7%) 6 (10%) 4 (7%) 2 (3%) Carcinoma 3 (5%) 2 (3%) 6 (10%) 4 (7%) Ovary (60) (60) (60) (60) Fibrosarcoma, Metastatic, Skin 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Granulosa-Theca Tumor Benign 1 (2%) Uterus (60) (60) (60) (60) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) 1 (2%) Carcinoma In Situ 1 (2%) Hemangiosarcoma 1 (2%) Leiomyoma 1 (2%) 1 (2%) Polyp Stromal 14 (23%) 6 (10%) 9 (15%) 7 (12%) Sarcoma Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (14) (15) (12) (7) Lymph Node, Mandibular (60) (59) (60) (59) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Lymph Node, Mesenteric (60) (59) (60) (60) Spleen (60) (60) (60) (60) Fibrosarcoma, Metastatic, Skin 1 (2%) Thymus (58) (57) (59) (58) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (59) (60) (60) Adenoma 2 (3%) 1 (2%) 2 (3%) 1 (2%) Carcinoma 6 (10%) 5 (8%) 1 (2%) 1 (2%) Fibroadenoma 14 (23%) 15 (25%) 11 (18%) 8 (13%) Skin (60) (60) (59) (60) Basal Cell Adenoma 1 (2%) Keratoacanthoma 1 (2%) Squamous Cell Carcinoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (3%) 3 (5%) Subcutaneous Tissue, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Osteosarcoma 1 (2%) Skeletal Muscle (1) (1) (1) Squamous Cell Carcinoma, Metastatic, Skin 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Oligodendroglioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Alveolar/Bronchiolar Adenoma 2 (3%) Alveolar/Bronchiolar Adenoma, Multiple, Two 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Page 4 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%) Nose (60) (60) (60) (60) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (2) (1) (1) Carcinoma 2 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Urinary Bladder (60) (60) (60) (60) Carcinoma, Metastatic, Uterus 1 (2%) Sarcoma Stromal, Metastatic, Uterus 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Leukemia Mononuclear 22 (37%) 20 (33%) 19 (32%) 14 (23%) Mesothelioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE VEHICLE 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 54 51 48 50 Total Primary Neoplasms 130 108 108 92 Total Animals with Benign Neoplasms 48 45 40 39 Total Benign Neoplasms 87 71 72 69 Total Animals with Malignant Neoplasms 33 31 29 22 Total Malignant Neoplasms 43 37 36 23 Total Animals with Metastatic Neoplasms 2 1 2 1 Total Metastatic Neoplasm 3 4 5 1 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant Total Uncertain Neoplasms ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 6 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 31 35 41 46 Natural Death 9 9 5 3 Survivors Terminal Sacrifice 10 6 4 1 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (60) (59) (60) (60) Intestine Large, Rectum (59) (58) (59) (60) Histiocytic Sarcoma, Metastatic, Liver 1 (2%) Intestine Large, Cecum (60) (59) (60) (60) Intestine Small, Duodenum (58) (53) (55) (60) Intestine Small, Jejunum (60) (57) (60) (60) Intestine Small, Ileum (60) (58) (59) (60) Liver (60) (60) (60) (60) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Mesentery (5) (7) (9) (3) Carcinoma, Metastatic, Pancreas 1 (11%) Fibrosarcoma, Metastatic, Skin 1 (33%) Hemangiosarcoma 1 (11%) Pancreas (60) (59) (60) (60) Carcinoma 1 (2%) 1 (2%) Acinar Cell, Adenoma 3 (5%) 6 (10%) 1 (2%) 1 (2%) Stomach, Forestomach (60) (60) (60) (60) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (60) (59) (60) (60) Tongue (1) (1) Squamous Cell Papilloma 1 (100%) 1 (100%) Tooth (1) Fibrosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50% CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Schwannoma Benign 1 (2%) Thymoma Malignant, Metastatic, Thymus 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Adenoma 1 (2%) Carcinoma, Metastatic, Pancreas 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Adrenal Medulla (60) (60) (60) (60) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Ganglioneuroma 1 (2%) Pheochromocytoma Malignant 4 (7%) 1 (2%) 2 (3%) Pheochromocytoma Benign 9 (15%) 6 (10%) 4 (7%) 4 (7%) Bilateral, Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (60) (59) (59) (59) Adenoma 15 (25%) 15 (25%) 7 (12%) 6 (10%) Carcinoma 2 (3%) 2 (3%) Histiocytic Sarcoma, Metastatic, Liver 1 (2%) Pituitary Gland (59) (60) (59) (58) Pars Distalis, Adenoma 39 (66%) 38 (63%) 35 (59%) 27 (47%) Pars Distalis, Carcinoma 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (60) (59) (60) (60) C-Cell, Adenoma 5 (8%) 5 (8%) 1 (2%) 5 (8%) C-Cell, Carcinoma 1 (2%) 2 (3%) 1 (2%) Follicular Cell, Adenoma 2 (3%) Follicular Cell, Carcinoma 2 (3%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (2) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (60) (60) Histiocytic Sarcoma, Metastatic, Liver 1 (2%) Preputial Gland (60) (60) (60) (59) Adenoma 2 (3%) 1 (2%) 1 (2%) 2 (3%) Carcinoma 1 (2%) 3 (5%) 3 (5%) 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Page 8 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50% CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Prostate (60) (60) (60) (60) Seminal Vesicle (60) (60) (60) (60) Testes (60) (60) (60) (60) Bilateral, Interstitial Cell, Adenoma 23 (38%) 17 (28%) 19 (32%) 24 (40%) Interstitial Cell, Adenoma 15 (25%) 17 (28%) 20 (33%) 16 (27%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (19) (11) (15) (20) Mediastinal, Carcinoma, Metastatic, Pancreas 1 (7%) Pancreatic, Carcinoma, Metastatic, Islets, Pancreatic 1 (7%) Lymph Node, Mandibular (60) (58) (59) (60) Lymph Node, Mesenteric (59) (59) (60) (60) Spleen (60) (59) (60) (60) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Thymus (54) (59) (57) (56) Thymoma Benign 1 (2%) 2 (4%) Thymoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (54) (58) (57) (56) Fibroadenoma 1 (2%) 2 (3%) 1 (2%) Skin (60) (60) (59) (60) Basal Cell Adenoma 2 (3%) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Keratoacanthoma 2 (3%) 2 (3%) 1 (2%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 3 (5%) 3 (5%) 2 (3%) 1 (2%) Sebaceous Gland, Adenoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 3 (5%) 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (3%) 1 (2%) 1 (2%) 1 (2%) Subcutaneous Tissue, Hemangiosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Chordoma 1 (2%) Skeletal Muscle (1) (1) (1) Carcinoma, Metastatic, Pancreas 1 (100%) Chordoma, Metastatic, Bone 1 (100%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50% CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Oligodendroglioma Benign 1 (2%) Spinal Cord (1) (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Islets, Pancreatic 1 (2%) Carcinoma, Metastatic, Pancreas 1 (2%) Carcinoma, Metastatic, Preputial Gland 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%) 1 (2%) Chordoma, Metastatic, Bone 1 (2%) Squamous Cell Carcinoma 1 (2%) Thymoma Malignant, Metastatic, Thymus 1 (2%) Nose (60) (60) (60) (60) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (1) Carcinoma 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Bilateral, Renal Tubule, Adenoma, Multiple 1 (2%) Renal Tubule, Adenoma 1 (2%) 3 (5%) 4 (7%) 2 (3%) Renal Tubule, Carcinoma 1 (2%) Renal Tubule, Oncocytoma Benign 1 (2%) Transitional Epithelium, Papilloma 1 (2%) Urinary Bladder (60) (60) (60) (60) Histiocytic Sarcoma, Metastatic, Liver 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 30 (50%) 28 (47%) 24 (40%) 25 (42%) Lymphoma Malignant Mixed 1 (2%) Mesothelioma Benign 1 (2%) * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50% CONTROL ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(60) *(60) *(60) *(60) Mesothelioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 05142-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC T-BUTYL ALCOHOL Date: 05/20/95 Route: DOSED WATER Time: 07:39:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE VEHICLE 0.125% 0.25% 0.50% CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 59 57 59 59 Total Primary Neoplasms 170 159 143 131 Total Animals with Benign Neoplasms 57 55 58 56 Total Benign Neoplasms 126 120 106 96 Total Animals with Malignant Neoplasms 38 33 32 30 Total Malignant Neoplasms 44 39 37 35 Total Animals with Metastatic Neoplasms 2 1 3 4 Total Metastatic Neoplasm 6 1 12 11 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant Total Uncertain Neoplasms ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------