TDMS Study 05128-06 Pathology Tables
NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 Facility: Southern Research Institute Chemical CAS #: 8003-22-3 Lock Date: 01/12/93 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: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 9 10 9 Early Deaths Moribund Sacrifice 25 23 12 25 Natural Death 3 2 1 3 Survivors Terminal Sacrifice 22 26 37 23 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (60) (58) (59) (60) Carcinoma 1 (2%) 1 (2%) Intestine Large, Rectum (59) (59) (59) (59) Histiocytic Sarcoma 1 (2%) Intestine Large, Cecum (60) (60) (59) (59) Intestine Small, Jejunum (59) (60) (60) (60) Leiomyosarcoma 1 (2%) Intestine Small, Ileum (58) (60) (59) (58) Liver (60) (60) (60) (60) Cholangiocarcinoma 1 (2%) 1 (2%) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) 5 (8%) 4 (7%) Hepatocellular Adenoma, Multiple 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Mesentery (12) (20) (8) (14) Cholangiocarcinoma, Metastatic, Liver 1 (7%) Osteosarcoma, Metastatic, Bone 1 (5%) Oral Mucosa (1) (1) (1) Squamous Cell Carcinoma 1 (100%) Squamous Cell Papilloma 1 (100%) 1 (100%) Pancreas (60) (60) (60) (60) Osteosarcoma, Metastatic, Bone 1 (2%) Salivary Glands (60) (55) (60) (59) Stomach, Forestomach (60) (60) (60) (60) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 2 (3%) 2 (3%) Stomach, Glandular (60) (60) (60) (60) Tongue (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Osteosarcoma, Metastatic, Bone 1 (2%) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Adenoma 1 (2%) Adrenal Medulla (58) (60) (59) (59) Pheochromocytoma Malignant 1 (2%) 1 (2%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 2 (3%) 1 (2%) 2 (3%) 1 (2%) Islets, Pancreatic (60) (60) (59) (60) Adenoma 1 (2%) 1 (2%) 1 (2%) Parathyroid Gland (58) (57) (57) (59) Adenoma 1 (2%) 1 (2%) Pituitary Gland (60) (60) (60) (60) Pars Distalis, Adenoma 23 (38%) 23 (38%) 18 (30%) 22 (37%) Pars Distalis, Adenoma, Multiple 1 (2%) Pars Distalis, Carcinoma 2 (3%) Thyroid Gland (60) (60) (60) (60) Bilateral, Follicular Cell, Carcinoma 1 (2%) C-Cell, Adenoma 2 (3%) 2 (3%) 4 (7%) 5 (8%) C-Cell, Adenoma, Multiple 1 (2%) C-Cell, Carcinoma 1 (2%) 1 (2%) Follicular Cell, Adenoma 1 (2%) 2 (3%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (59) (59) (59) (60) Adenoma 11 (19%) 4 (7%) 5 (8%) 4 (7%) Carcinoma 5 (8%) 3 (5%) 6 (10%) 3 (5%) Bilateral, Carcinoma 1 (2%) Ovary (60) (60) (60) (60) Granulosa Cell Tumor Malignant 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Uterus (60) (60) (60) (60) Page 3 NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Adenoma 1 (2%) Carcinoma 1 (2%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Polyp Stromal 13 (22%) 13 (22%) 10 (17%) 6 (10%) Polyp Stromal, Multiple 1 (2%) Schwannoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (10) (13) (13) (17) Lymph Node, Mandibular (60) (60) (60) (58) Lymph Node, Mesenteric (60) (60) (60) (60) Lymph Node, Mediastinal (1) (3) (2) (3) Cholangiocarcinoma, Metastatic, Liver 1 (33%) Spleen (60) (59) (60) (60) Fibrous Histiocytoma 1 (2%) Thymus (60) (58) (59) (58) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (60) (60) (60) Adenoma 2 (3%) Carcinoma 5 (8%) 5 (8%) 2 (3%) 4 (7%) Carcinoma, Multiple 1 (2%) Fibroadenoma 14 (23%) 13 (22%) 18 (30%) 17 (28%) Fibroadenoma, Multiple 7 (12%) 9 (15%) 5 (8%) 9 (15%) Histiocytic Sarcoma 1 (2%) Skin (59) (60) (60) (60) Basal Cell Carcinoma 1 (2%) Histiocytic Sarcoma 1 (2%) Squamous Cell Carcinoma 2 (3%) Squamous Cell Papilloma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Osteosarcoma 1 (2%) 1 (2%) 1 (2%) Skeletal Muscle (2) (1) Osteosarcoma, Metastatic, Bone 1 (50%) Rhabdomyosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Astrocytoma Malignant 1 (2%) Carcinoma, Metastatic, Pituitary Gland 2 (3%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (3%) 1 (2%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 2 (3%) Carcinoma, Metastatic, Uterus 1 (2%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Sarcoma 1 (2%) Renal Tubule, Carcinoma 1 (2%) Transitional Epithelium, Carcinoma 1 (2%) Transitional Epithelium, Hemangioma 1 (2%) Urinary Bladder (60) (60) (60) (60) Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 16 (27%) 21 (35%) 19 (32%) 16 (27%) Lymphoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 52 53 53 53 Total Primary Neoplasms 115 111 110 119 Total Animals with Benign Neoplasms 44 46 44 43 Total Benign Neoplasms 80 74 74 78 Total Animals with Malignant Neoplasms 32 30 30 30 Total Malignant Neoplasms 35 37 36 41 Total Animals with Metastatic Neoplasms 1 1 4 Total Metastatic Neoplasm 1 5 8 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: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 9 9 6 Early Deaths Moribund Sacrifice 29 29 41 49 Natural Death 2 2 1 3 Survivors Terminal Sacrifice 19 20 8 2 Other 1 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (59) (59) (58) (59) Polyp Adenomatous 1 (2%) Intestine Large, Cecum (60) (59) (59) (60) Hemangioma 1 (2%) Intestine Small, Jejunum (60) (59) (60) (60) Carcinoma 1 (2%) 1 (2%) Intestine Small, Ileum (59) (59) (59) (60) Carcinoma 1 (2%) Liver (60) (60) (60) (60) Hepatocellular Adenoma 1 (2%) 2 (3%) 1 (2%) 6 (10%) Hepatocellular Adenoma, Multiple 1 (2%) Mesentery (12) (12) (10) (13) Lipoma 1 (8%) Oral Mucosa (2) (3) (4) Squamous Cell Carcinoma 1 (50%) 1 (33%) 1 (25%) Squamous Cell Papilloma 1 (50%) 1 (33%) 2 (50%) Pancreas (60) (60) (60) (60) Acinar Cell, Adenoma 1 (2%) 4 (7%) 2 (3%) Salivary Glands (60) (60) (59) (60) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Stomach, Forestomach (60) (60) (60) (60) Squamous Cell Papilloma 2 (3%) Stomach, Glandular (60) (60) (60) (60) Carcinoma 1 (2%) Tongue (1) (1) (1) (4) Squamous Cell Carcinoma 1 (100%) Squamous Cell Papilloma 1 (100%) 1 (100%) 2 (50%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Adrenal Medulla (60) (59) (60) (60) Neuroblastoma Malignant 1 (2%) Pheochromocytoma Malignant 4 (7%) 1 (2%) 2 (3%) Pheochromocytoma Benign 7 (12%) 8 (14%) 11 (18%) 6 (10%) Bilateral, Pheochromocytoma Benign 1 (2%) 2 (3%) Islets, Pancreatic (60) (60) (60) (60) Adenoma 4 (7%) 3 (5%) Carcinoma 1 (2%) 2 (3%) Pituitary Gland (60) (59) (58) (58) Pars Distalis, Adenoma 21 (35%) 7 (12%) 13 (22%) 8 (14%) Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) 2 (3%) Pars Intermedia, Adenoma 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (60) (60) (59) (60) C-Cell, Adenoma 5 (8%) 2 (3%) 3 (5%) 3 (5%) C-Cell, Adenoma, Multiple 1 (2%) 1 (2%) C-Cell, Carcinoma 1 (2%) 1 (2%) Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 3 (5%) 1 (2%) 1 (2%) 3 (5%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (2) (1) (3) (3) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (59) (60) (60) (60) Preputial Gland (59) (59) (60) (60) Adenoma 5 (8%) 2 (3%) 1 (2%) Carcinoma 5 (8%) 4 (7%) 1 (2%) 2 (3%) Prostate (60) (60) (60) (59) Adenocarcinoma 1 (2%) Seminal Vesicle (60) (60) (60) (60) Testes (59) (60) (60) (60) Bilateral, Interstitial Cell, Adenoma 30 (51%) 36 (60%) 42 (70%) 39 (65%) Interstitial Cell, Adenoma 9 (15%) 13 (22%) 7 (12%) 7 (12%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (22) (25) (30) (47) Renal, Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (5%) Lymph Node, Mandibular (60) (59) (59) (59) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Lymph Node, Mesenteric (60) (59) (60) (60) Spleen (60) (60) (60) (60) Hemangiosarcoma 1 (2%) Thymus (58) (58) (58) (59) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (58) (57) (56) (58) Fibroadenoma 3 (5%) 2 (4%) 3 (5%) 1 (2%) Skin (60) (58) (60) (60) Basal Cell Adenoma 1 (2%) 1 (2%) 2 (3%) Basal Cell Carcinoma 2 (3%) Keratoacanthoma 7 (12%) 4 (7%) 2 (3%) 1 (2%) Squamous Cell Papilloma 3 (5%) 3 (5%) 2 (3%) 3 (5%) Trichoepithelioma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) Sebaceous Gland, Carcinoma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibroma 3 (5%) 2 (3%) 3 (5%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Osteosarcoma 1 (2%) Skeletal Muscle (1) (2) (5) (9) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Hemangioma 1 (2%) Spinal Cord (1) (2) (1) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Alveolar/Bronchiolar Adenoma 7 (12%) 1 (2%) 2 (3%) 1 (2%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (1) Carcinoma 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Osteosarcoma, Metastatic, Bone 1 (2%) Renal Tubule, Adenoma 2 (3%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (60) (60) (60) (60) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Leukemia Mononuclear 37 (62%) 36 (60%) 20 (33%) 22 (37%) Lymphoma Malignant 1 (2%) Mesothelioma Malignant 2 (3%) 2 (3%) 3 (5%) 4 (7%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05128-06 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC D & C YELLOW NO. 11 Date: 04/03/96 Route: DOSED FEED Time: 23:34:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.05% 0.17% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 51 55 51 50 Total Primary Neoplasms 171 144 140 128 Total Animals with Benign Neoplasms 50 53 50 50 Total Benign Neoplasms 112 95 103 90 Total Animals with Malignant Neoplasms 42 40 30 26 Total Malignant Neoplasms 59 49 37 38 Total Animals with Metastatic Neoplasms 2 1 Total Metastatic Neoplasm 3 3 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 ---------- ------------------------------------------------------------