TDMS Study 05057-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) HC YELLOW 4 NTP Experiment-Test: 05057-01 Report: PEIRPT05 Study Type: CHRONIC Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 Facility: TSI Mason Research Chemical CAS #: 5982043-8 Lock Date: None 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: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 70 70 Scheduled Sacrifice 20 20 20 Early Deaths Moribund 21 15 15 Dead 2 4 1 Survivors Terminal Sacrifice 26 30 34 Moribund 1 1 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (48) (49) (49) Intestine Large, Colon (48) (47) (47) Intestine Large, Rectum (48) (46) (49) Intestine Small, Duodenum (49) (48) (49) Intestine Small, Ileum (49) (47) (50) Liver (50) (50) (50) Carcinoma, Metastatic, Ovary 1 (2%) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) Mesentery (3) (4) (6) Carcinoma, Metastatic, Ovary 1 (25%) Pancreas (49) (50) (49) Acinus, Adenoma 2 (4%) 2 (4%) Salivary Glands (50) (50) (50) Stomach, Forestomach (50) (48) (50) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (50) (50) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (49) (50) Adenoma 1 (2%) 1 (2%) Adrenal Gland, Medulla (49) (46) (49) Pheochromocytoma Malignant 1 (2%) Page 2 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pheochromocytoma Benign 1 (2%) 3 (7%) 2 (4%) Islets, Pancreatic (50) (50) (48) Adenoma 1 (2%) 1 (2%) Parathyroid Gland (46) (39) (45) Adenoma 1 (2%) 1 (3%) Pituitary Gland (49) (48) (49) Pars Distalis, Adenoma 31 (63%) 31 (65%) 29 (59%) Pars Distalis, Adenoma, Multiple 2 (4%) 4 (8%) 1 (2%) Pars Distalis, Carcinoma 1 (2%) Thyroid Gland (50) (50) (50) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 9 (18%) 7 (14%) 7 (14%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (47) (44) Adenoma 6 (13%) 5 (11%) 2 (5%) Carcinoma 2 (5%) Bilateral, Adenoma 1 (2%) Ovary (50) (49) (50) Carcinoma 1 (2%) Granulosa Cell Tumor Benign 1 (2%) Uterus (48) (50) (50) Polyp Stromal 4 (8%) 7 (14%) 12 (24%) Polyp Stromal, Multiple 1 (2%) Sarcoma Stromal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (49) Lymph Node (50) (50) (50) Mediastinal, Carcinoma, Metastatic, Ovary 1 (2%) Mediastinal, Carcinoma, Metastatic, Thyroid Gland 1 (2%) Lymph Node, Mandibular (49) (45) (48) Adenocarcinoma, Metastatic, Mammary Gland 1 (2%) Lymph Node, Mesenteric (49) (50) (49) Spleen (50) (49) (50) Page 3 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Thymus (47) (42) (43) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (37) (47) Adenocarcinoma 1 (2%) Adenoma 3 (6%) 2 (4%) Fibroadenoma 19 (40%) 16 (43%) 16 (34%) Fibroadenoma, Multiple 9 (19%) 3 (8%) 2 (4%) Skin (48) (50) (49) Basal Cell Carcinoma 1 (2%) Carcinoma Adenosquamous 1 (2%) Keratoacanthoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 3 (6%) 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) (1) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) Carcinoma, Metastatic, Pituitary Gland 1 (2%) Oligodendroglioma Malignant 1 (2%) Spinal Cord (1) (2) Neoplasm NOS 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Adenocarcinoma, Metastatic, Mammary Gland 1 (2%) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 2 (4%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) Carcinoma Adenosquamous, Metastatic, Skin 1 (2%) Squamous Cell Carcinoma, Metastatic, Nose 1 (2%) Nose (50) (49) (48) Squamous Cell Carcinoma 1 (2%) Trachea (50) (50) (50) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) (3) (3) Fibroma 1 (50%) Squamous Cell Papilloma 1 (33%) Harderian Gland (9) (4) (15) Adenoma 1 (11%) 1 (7%) Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) Urinary Bladder (48) (48) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Leukemia Mononuclear 14 (28%) 15 (30%) 10 (20%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 49 48 Total Primary Neoplasms 119 106 96 Total Animals with Benign Neoplasms 43 48 43 Total Benign Neoplasms 96 88 83 Total Animals with Malignant Neoplasms 19 18 13 Total Malignant Neoplasms 22 18 13 Total Animals with Metastatic Neoplasms 4 2 Total Metastatic Neoplasm 5 4 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 Total Uncertain Neoplasms 1 ____________________________________________________________________________________________________________________________________ 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: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 70 70 70 Scheduled Sacrifice 19 20 20 Early Deaths Moribund 24 17 18 Dead 6 4 3 Survivors Terminal Sacrifice 21 29 28 Wrong Sex 1 Animals Examined Microscopically 50 50 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (48) (48) (49) Intestine Large, Cecum (47) (48) (46) Intestine Large, Colon (48) (44) (45) Polyp Adenomatous 1 (2%) Intestine Small, Duodenum (47) (48) (47) Intestine Small, Ileum (45) (48) (46) Intestine Small, Jejunum (46) (47) (46) Sarcoma 1 (2%) Liver (50) (50) (49) Adenocarcinoma, Metastatic, Lung 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) Hepatocellular Adenoma 1 (2%) Mesentery (3) (5) (1) Pancreas (50) (48) (48) Acinus, Adenoma 1 (2%) 3 (6%) 2 (4%) Acinus, Adenoma, Multiple 1 (2%) 1 (2%) Pharynx (1) Palate, Squamous Cell Papilloma 1 (100%) Salivary Glands (49) (50) (48) Sarcoma 1 (2%) Stomach, Forestomach (50) (48) (49) Squamous Cell Papilloma 1 (2%) 1 (2%) Stomach, Glandular (49) (48) (48) Tongue (3) Squamous Cell Papilloma 2 (67%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (49) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) (48) Carcinoma 1 (2%) Adrenal Gland, Medulla (50) (49) (48) Pheochromocytoma Malignant 2 (4%) 1 (2%) Pheochromocytoma Benign 13 (26%) 11 (22%) 14 (29%) Bilateral, Pheochromocytoma Benign 6 (12%) 6 (12%) 2 (4%) Islets, Pancreatic (48) (47) (48) Adenoma 1 (2%) 4 (9%) 3 (6%) Parathyroid Gland (47) (44) (37) Adenoma 2 (5%) Pituitary Gland (45) (49) (49) Pars Distalis, Adenoma 17 (38%) 18 (37%) 26 (53%) Pars Distalis, Adenoma, Multiple 2 (4%) 2 (4%) Thyroid Gland (49) (49) (48) C-Cell, Adenoma 6 (12%) 5 (10%) 6 (13%) C-Cell, Adenoma, Multiple 1 (2%) Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (50) (49) Preputial Gland (48) (50) (49) Adenoma 8 (17%) 13 (26%) 7 (14%) Carcinoma 1 (2%) Bilateral, Adenoma 1 (2%) 1 (2%) Prostate (48) (49) (46) Seminal Vesicle (48) (50) (48) Testes (50) (50) (49) Bilateral, Interstitial Cell, Adenoma 37 (74%) 40 (80%) 36 (73%) Interstitial Cell, Adenoma 10 (20%) 3 (6%) 5 (10%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (50) (48) Lymph Node (50) (50) (49) Lymph Node, Mandibular (46) (46) (46) Lymph Node, Mesenteric (49) (50) (47) Spleen (50) (50) (48) Sarcoma 1 (2%) Thymus (41) (43) (47) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (28) (18) (26) Adenoma 1 (4%) 1 (4%) Fibroadenoma 3 (11%) 1 (6%) Skin (48) (50) (47) Basal Cell Carcinoma 1 (2%) Keratoacanthoma 1 (2%) 1 (2%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 5 (10%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (49) Osteosarcoma 1 (2%) Skeletal Muscle (1) (2) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (49) Astrocytoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (49) Adenocarcinoma 1 (2%) Alveolar/Bronchiolar Adenoma 2 (4%) 1 (2%) 3 (6%) Carcinoma, Metastatic, Adrenal Gland 1 (2%) Carcinoma, Metastatic, Preputial Gland 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Page 9 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Osteosarcoma, Metastatic, Uncertain Primary Site 1 (2%) Pheochromocytoma Malignant, Metastatic, Adrenal Gland 1 (2%) Mediastinum, Adenocarcinoma, Metastatic, Lung 1 (2%) Mediastinum, Sarcoma, Metastatic, Salivary Glands 1 (2%) Nose (47) (50) (49) Squamous Cell Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (6) (4) (2) Squamous Cell Carcinoma 1 (25%) Squamous Cell Papilloma 1 (17%) Harderian Gland (1) (1) (6) Adenoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (49) Adenocarcinoma, Metastatic, Lung 1 (2%) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (48) (48) (47) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(49) Leukemia Mononuclear 19 (38%) 21 (42%) 16 (33%) Lymphoma Malignant Undifferentiated Cell 2 (4%) 1 (2%) Mesothelioma Malignant 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:27:24 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 50 48 Total Primary Neoplasms 143 148 136 Total Animals with Benign Neoplasms 49 49 48 Total Benign Neoplasms 115 119 114 Total Animals with Malignant Neoplasms 27 27 19 Total Malignant Neoplasms 28 29 22 Total Animals with Metastatic Neoplasms 4 3 1 Total Metastatic Neoplasm 4 3 3 Total Animals with Malignant Neoplasms 1 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 ---------- ------------------------------------------------------------