TDMS Study 05094-03 Pathology Tables
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 Facility: Southern Research Institute Chemical CAS #: 85-68-7 Lock Date: 11/25/92 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: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 110 110 Scheduled Sacrifice 10 10 Early Deaths Dead 4 1 Moribund 11 10 Moribund Sacrifice 34 38 Natural Death 6 1 Survivors Terminal Sacrifice 10 11 Animals Examined Microscopically 110 110 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (109) (109) Intestine Large, Cecum (110) (110) Intestine Small, Duodenum (109) (110) Intestine Small, Jejunum (110) (110) Leiomyosarcoma 1 (1%) 1 (1%) Intestine Small, Ileum (110) (110) Liver (110) (110) Hepatocellular Carcinoma 3 (3%) Hepatocellular Adenoma 2 (2%) 4 (4%) Mesentery (6) (5) Lipoma 1 (20%) Pancreas (107) (110) Acinus, Adenoma 1 (1%) Salivary Glands (109) (110) Stomach, Forestomach (107) (110) Stomach, Glandular (108) (110) Tongue (1) Squamous Cell Papilloma 1 (100%) Tooth (4) Odontoma 1 (25%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (110) (110) Schwannoma Malignant 1 (1%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (110) (110) Carcinoma 1 (1%) Adrenal Medulla (108) (110) Pheochromocytoma Malignant 1 (1%) Pheochromocytoma Complex 1 (1%) Pheochromocytoma Benign 3 (3%) 5 (5%) Islets, Pancreatic (107) (110) Adenoma 1 (1%) 1 (1%) Carcinoma 1 (1%) Pituitary Gland (110) (109) Pars Distalis, Adenoma 39 (35%) 22 (20%) Pars Distalis, Adenoma, Multiple 2 (2%) Pars Distalis, Carcinoma 1 (1%) Thyroid Gland (109) (110) C-Cell, Adenoma 6 (6%) 7 (6%) C-Cell, Carcinoma 1 (1%) Follicular Cell, Adenoma 1 (1%) Follicular Cell, Carcinoma 1 (1%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (110) (109) Adenoma 9 (8%) 5 (5%) Carcinoma 5 (5%) Ovary (110) (110) Granulosa Cell Tumor Benign 1 (1%) Uterus (110) (110) Adenoma 1 (1%) Polyp Stromal 3 (3%) 9 (8%) Polyp Stromal, Multiple 1 (1%) Sarcoma Stromal 1 (1%) Vagina (2) (2) Squamous Cell Papilloma 1 (50%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (110) (110) Lymph Node (32) (27) Lymph Node, Mandibular (109) (110) Lymph Node, Mesenteric (110) (110) Spleen (110) (110) Thymus (109) (106) Thymoma Benign 1 (1%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (109) (109) Carcinoma 5 (5%) 1 (1%) Fibroadenoma 28 (26%) 7 (6%) Fibroadenoma, Multiple 5 (5%) Skin (110) (109) Keratoacanthoma 3 (3%) 1 (1%) Squamous Cell Papilloma 2 (2%) Sebaceous Gland, Basal Cell Adenoma 1 (1%) Subcutaneous Tissue, Fibroma 4 (4%) Subcutaneous Tissue, Fibroma, Multiple 1 (1%) Subcutaneous Tissue, Melanoma Malignant 1 (1%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (110) (110) Osteosarcoma 1 (1%) Skeletal Muscle (1) Rhabdomyosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (110) (109) Astrocytoma Malignant 1 (1%) 1 (1%) Carcinoma, Metastatic, Pituitary Gland 1 (1%) Carcinoma, Metastatic, Zymbal's Gland 1 (1%) Ependymoma Malignant 1 (1%) Glioma Malignant 1 (1%) Oligodendroglioma Malignant 1 (1%) 1 (1%) Spinal Cord (3) (1) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (110) (110) Alveolar/Bronchiolar Adenoma 1 (1%) 1 (1%) Alveolar/Bronchiolar Carcinoma 1 (1%) Carcinoma, Metastatic, Zymbal's Gland 1 (1%) Sarcoma, Metastatic, Tissue NOS 1 (1%) Nose (110) (110) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (2) (2) Carcinoma 2 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (110) (110) Urinary Bladder (109) (110) Mast Cell Tumor Benign 1 (1%) Transitional Epithelium, Carcinoma 4 (4%) Transitional Epithelium, Papilloma 1 (1%) 4 (4%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(110) *(110) Leukemia Mononuclear 45 (41%) 58 (53%) Mesothelioma NOS 1 (1%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 94 78 Total Primary Neoplasms 192 144 Total Animals with Benign Neoplasms 74 49 Total Benign Neoplasms 119 69 Total Animals with Malignant Neoplasms 63 62 Total Malignant Neoplasms 73 74 Total Animals with Metastatic Neoplasms 2 1 Total Metastatic Neoplasm 2 2 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 Total Uncertain Neoplasms 2 ____________________________________________________________________________________________________________________________________ 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: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 110 110 Scheduled Sacrifice 10 10 Early Deaths Moribund 14 17 Accidently Killed 1 Dead 1 2 Moribund Sacrifice 37 29 Natural Death 3 8 Survivors Terminal Sacrifice 10 13 Animals Examined Microscopically 110 110 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (108) (106) Intestine Large, Cecum (108) (109) Intestine Small, Duodenum (110) (109) Intestine Small, Jejunum (109) (108) Carcinoma 2 (2%) Intestine Small, Ileum (109) (108) Sarcoma 1 (1%) Liver (110) (109) Hepatocellular Carcinoma 2 (2%) Hepatocellular Adenoma 2 (2%) Hepatocellular Adenoma, Multiple 1 (1%) Histiocytic Sarcoma 1 (1%) Mesentery (22) (19) Fibrous Histiocytoma 1 (5%) Sarcoma 1 (5%) Schwannoma Malignant 1 (5%) Oral Mucosa (3) (1) Squamous Cell Carcinoma 2 (67%) Squamous Cell Papilloma 1 (33%) 1 (100%) Pancreas (110) (109) Sarcoma, Metastatic, Mesentery 1 (1%) Acinar Cell, Adenoma 1 (1%) Acinus, Adenoma 1 (1%) Acinus, Adenoma, Multiple 1 (1%) Salivary Glands (110) (109) Fibrous Histiocytoma, Metastatic, Skin 1 (1%) Schwannoma Malignant 1 (1%) Stomach, Forestomach (110) (110) Page 7 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Leiomyosarcoma 1 (1%) Squamous Cell Papilloma 5 (5%) 1 (1%) Stomach, Glandular (110) (109) Tongue (2) (1) Squamous Cell Carcinoma 1 (50%) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (110) (110) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (110) (110) Adenoma 1 (1%) Adrenal Medulla (110) (110) Pheochromocytoma Malignant 1 (1%) 2 (2%) Pheochromocytoma Benign 9 (8%) 10 (9%) Pheochromocytoma Benign, Multiple 1 (1%) Bilateral, Pheochromocytoma Benign 2 (2%) Islets, Pancreatic (110) (109) Adenoma 7 (6%) 6 (6%) Carcinoma 3 (3%) 3 (3%) Pituitary Gland (106) (105) Pars Distalis, Adenoma 11 (10%) 11 (10%) Pars Distalis, Adenoma, Multiple 2 (2%) Thyroid Gland (110) (110) C-Cell, Adenoma 8 (7%) 8 (7%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (4) (3) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (110) (110) Preputial Gland (110) (110) Adenoma 1 (1%) 3 (3%) Carcinoma 1 (1%) Prostate (109) (110) Adenoma 1 (1%) Carcinoma 1 (1%) Seminal Vesicle (110) (108) Page 8 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Testes (110) (110) Bilateral, Interstitial Cell, Adenoma 80 (73%) 81 (74%) Interstitial Cell, Adenoma 20 (18%) 18 (16%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (110) (110) Histiocytic Sarcoma 1 (1%) Lymph Node (42) (42) Mediastinal, Fibrous Histiocytoma 1 (2%) Mediastinal, Histiocytic Sarcoma 1 (2%) Lymph Node, Mandibular (107) (106) Histiocytic Sarcoma 1 (1%) Lymph Node, Mesenteric (110) (109) Histiocytic Sarcoma 1 (1%) Spleen (110) (109) Fibroma 1 (1%) Sarcoma 1 (1%) Thymus (102) (103) Thymoma Benign 2 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (104) (108) Carcinoma 1 (1%) Fibroadenoma 5 (5%) 3 (3%) Skin (109) (108) Keratoacanthoma 4 (4%) 4 (4%) Trichoepithelioma 1 (1%) Subcutaneous Tissue, Fibroma 5 (5%) 3 (3%) Subcutaneous Tissue, Fibrosarcoma 1 (1%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (1%) Subcutaneous Tissue, Lipoma 1 (1%) Subcutaneous Tissue, Melanoma Benign 2 (2%) Subcutaneous Tissue, Melanoma Malignant 1 (1%) 1 (1%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (2) Fibrous Histiocytoma 1 (50%) Fibrous Histiocytoma, Metastatic, Skin 1 (50%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (110) (109) Astrocytoma Malignant 2 (2%) 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (110) (110) Alveolar/Bronchiolar Adenoma 1 (1%) 2 (2%) Alveolar/Bronchiolar Carcinoma 1 (1%) 1 (1%) Sarcoma, Metastatic, Mesentery 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Schwannoma Malignant 1 (100%) Zymbal's Gland (2) (1) Carcinoma 2 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (110) (109) Urinary Bladder (110) (110) Transitional Epithelium, Carcinoma 1 (1%) Transitional Epithelium, Papilloma 2 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(110) *(110) Histiocytic Sarcoma 1 (1%) Leukemia Mononuclear 60 (55%) 64 (58%) Mesothelioma Malignant 4 (4%) 3 (3%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 15:03:21 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 107 104 Total Primary Neoplasms 252 253 Total Animals with Benign Neoplasms 103 102 Total Benign Neoplasms 165 166 Total Animals with Malignant Neoplasms 75 75 Total Malignant Neoplasms 87 87 Total Animals with Metastatic Neoplasms 1 1 Total Metastatic Neoplasm 2 2 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 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------