TDMS Study 05182-03 Pathology Tables
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 Facility: TSI Mason Research Chemical CAS #: 77-09-8 Lock Date: 01/24/94 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: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 9 8 7 8 Natural Death 11 4 11 4 Survivors Terminal Sacrifice 30 38 32 38 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (48) (49) (49) (49) Intestine Large, Cecum (45) (49) (47) (48) Intestine Small, Duodenum (46) (49) (49) (48) Intestine Small, Jejunum (44) (49) (47) (48) Intestine Small, Ileum (47) (49) (45) (49) Liver (50) (50) (50) (49) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) 1 (2%) 1 (2%) Hepatocellular Adenoma, Multiple 1 (2%) Mesentery (12) (7) (6) (7) Carcinoma, Metastatic, Uterus 1 (8%) Oral Mucosa (3) Squamous Cell Papilloma 2 (67%) Pancreas (49) (49) (49) (46) Carcinoma, Metastatic, Uterus 1 (2%) Acinus, Adenoma 1 (2%) Salivary Glands (50) (50) (50) (49) Stomach, Forestomach (49) (50) (50) (49) Stomach, Glandular (48) (50) (50) (48) Tongue (2) (3) (2) Squamous Cell Carcinoma 2 (100%) 1 (33%) Tooth (1) (2) Adamantinoma Malignant 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (49) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (49) (49) Adenoma 2 (4%) 1 (2%) 1 (2%) 2 (4%) Adrenal Medulla (50) (50) (50) (49) Pheochromocytoma Malignant 1 (2%) 1 (2%) Pheochromocytoma Benign 2 (4%) 9 (18%) 9 (18%) 2 (4%) Bilateral, Pheochromocytoma Benign 1 (2%) 2 (4%) Islets, Pancreatic (49) (49) (49) (47) Adenoma 2 (4%) 1 (2%) 1 (2%) Carcinoma 3 (6%) 1 (2%) Pituitary Gland (50) (49) (50) (47) Pars Distalis, Adenoma 35 (70%) 32 (65%) 29 (58%) 25 (53%) Pars Distalis, Carcinoma 1 (2%) Thyroid Gland (50) (50) (50) (48) C-Cell, Adenoma 7 (14%) 5 (10%) 7 (14%) 7 (15%) C-Cell, Carcinoma 1 (2%) 3 (6%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (49) (48) Adenoma 9 (18%) 7 (14%) 3 (6%) 7 (15%) Carcinoma 1 (2%) 1 (2%) Bilateral, Adenoma 1 (2%) 1 (2%) Ovary (50) (50) (50) (50) Cystadenoma 1 (2%) Granulosa Cell Tumor Malignant 1 (2%) Granulosa Cell Tumor Benign 2 (4%) Granulosa-Theca Tumor Benign 1 (2%) Bilateral, Tubulostromal Adenoma 1 (2%) Uterus (50) (50) (50) (50) Carcinoma 1 (2%) Histiocytic Sarcoma 1 (2%) Schwannoma Malignant 1 (2%) Endometrium, Polyp Stromal 3 (6%) 7 (14%) 5 (10%) 4 (8%) Endometrium, Polyp Stromal, Multiple 1 (2%) 1 (2%) 1 (2%) 1 (2%) Endometrium, Sarcoma Stromal 1 (2%) Vagina (1) (1) Schwannoma Malignant 1 (100%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Histiocytic Sarcoma 1 (2%) 1 (2%) Lymph Node (7) (11) (9) (9) Mediastinal, Carcinoma, Metastatic, Uterus 1 (14%) Lymph Node, Mandibular (50) (50) (50) (48) Lymph Node, Mesenteric (49) (50) (49) (48) Carcinoma, Metastatic, Uterus 1 (2%) Spleen (50) (50) (50) (49) Fibrosarcoma 1 (2%) Histiocytic Sarcoma, Metastatic, Bone Marrow 1 (2%) Thymus (50) (49) (49) (48) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (48) (49) Adenoma 2 (4%) Carcinoma 3 (6%) 3 (6%) Fibroadenoma 21 (42%) 25 (50%) 11 (23%) 19 (39%) Fibroadenoma, Multiple 9 (18%) 6 (13%) 5 (10%) Skin (50) (50) (49) (50) Lip, Basal Cell Adenoma 1 (2%) Pinna, Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (3) (3) (2) Sarcoma 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Cerebellum, Granular Cell Tumor Malignant 1 (2%) Cerebrum, Astrocytoma Malignant 2 (4%) Spinal Cord (1) (2) (2) (2) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 3 (6%) 3 (6%) 1 (2%) 2 (4%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Uterus 1 (2%) Page 4 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Histiocytic Sarcoma, Metastatic, Bone Marrow 1 (2%) Nose (50) (49) (50) (50) Turbinate, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Pelvis, Transitional Epithelium, Papilloma 1 (2%) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (49) (49) (49) (49) Carcinoma, Metastatic, Uterus 1 (2%) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) Leukemia Mononuclear 21 (42%) 21 (42%) 17 (34%) 14 (28%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 50 50 49 Total Primary Neoplasms 138 133 98 108 Total Animals with Benign Neoplasms 43 49 42 41 Total Benign Neoplasms 102 102 76 82 Total Animals with Malignant Neoplasms 30 25 21 23 Total Malignant Neoplasms 36 31 22 26 Total Animals with Metastatic Neoplasms 2 Total Metastatic Neoplasm 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: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 15 15 13 16 Natural Death 14 20 22 21 Survivors Terminal Sacrifice 21 15 14 13 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (48) (49) (49) (48) Intestine Large, Rectum (48) (49) (50) (50) Intestine Large, Cecum (44) (41) (44) (40) Intestine Small, Duodenum (47) (50) (49) (47) Intestine Small, Jejunum (47) (41) (47) (42) Intestine Small, Ileum (44) (40) (40) (41) Liver (50) (50) (50) (50) Hepatocellular Adenoma 1 (2%) 3 (6%) 1 (2%) Hepatocellular Adenoma, Multiple 1 (2%) Histiocytic Sarcoma 1 (2%) Mesentery (20) (7) (3) (3) Histiocytic Sarcoma 1 (33%) Oral Mucosa (1) (1) Pharyngeal, Squamous Cell Carcinoma 1 (100%) Pharyngeal, Squamous Cell Papilloma 1 (100%) Pancreas (50) (50) (50) (47) Histiocytic Sarcoma 1 (2%) Acinus, Adenoma 2 (4%) 1 (2%) Acinus, Adenoma, Multiple 1 (2%) Salivary Glands (50) (49) (49) (49) Stomach, Forestomach (50) (50) (50) (49) Stomach, Glandular (50) (50) (50) (49) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) (50) (50) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Adenoma 1 (2%) Adrenal Medulla (50) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) 1 (2%) 2 (4%) Pheochromocytoma Benign 14 (28%) 15 (30%) 15 (30%) 19 (38%) Bilateral, Pheochromocytoma Malignant 1 (2%) Bilateral, Pheochromocytoma Benign 3 (6%) 19 (38%) 19 (38%) 15 (30%) Islets, Pancreatic (50) (50) (50) (48) Adenoma 3 (6%) 2 (4%) 1 (2%) Carcinoma 1 (2%) 2 (4%) 1 (2%) 2 (4%) Parathyroid Gland (41) (48) (49) (46) Adenoma 1 (2%) Pituitary Gland (50) (50) (50) (50) Pars Distalis, Adenoma 13 (26%) 11 (22%) 16 (32%) 11 (22%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (50) (50) (49) (49) Bilateral, C-Cell, Adenoma 1 (2%) Bilateral, Follicular Cell, Adenoma 1 (2%) C-Cell, Adenoma 8 (16%) 2 (4%) 3 (6%) 4 (8%) C-Cell, Carcinoma 1 (2%) 2 (4%) Follicular Cell, Adenoma 2 (4%) 3 (6%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Preputial Gland (50) (49) (50) (49) Adenoma 4 (8%) 4 (8%) 4 (8%) 4 (8%) Carcinoma 2 (4%) 2 (4%) Bilateral, Adenoma 1 (2%) Bilateral, Carcinoma 1 (2%) Prostate (50) (50) (50) (50) Adenoma 2 (4%) Seminal Vesicle (50) (50) (50) (50) Testes (50) (50) (50) (50) Bilateral, Interstitial Cell, Adenoma 42 (84%) 42 (84%) 46 (92%) 45 (90%) Interstitial Cell, Adenoma 4 (8%) 4 (8%) 3 (6%) 4 (8%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (48) (50) (50) (49) Lymph Node (17) (22) (27) (20) Mediastinal, Carcinoma, Metastatic, Kidney 1 (5%) Renal, Carcinoma, Metastatic, Kidney 1 (5%) Lymph Node, Mandibular (50) (49) (49) (49) Lymph Node, Mesenteric (50) (50) (47) (48) Histiocytic Sarcoma 1 (2%) Spleen (50) (50) (50) (49) Fibrosarcoma 1 (2%) Hemangioma 1 (2%) Histiocytic Sarcoma 1 (2%) Thymus (50) (49) (47) (47) Histiocytic Sarcoma 1 (2%) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (43) (47) (48) (47) Adenoma 1 (2%) 1 (2%) Fibroadenoma 5 (12%) 2 (4%) 2 (4%) 1 (2%) Fibroadenoma, Multiple 1 (2%) Skin (49) (50) (50) (50) Basal Cell Adenoma 2 (4%) 1 (2%) Keratoacanthoma 4 (8%) 2 (4%) 3 (6%) 1 (2%) Squamous Cell Carcinoma 1 (2%) Pinna, Schwannoma Malignant 1 (2%) 2 (4%) Subcutaneous Tissue, Fibroma 2 (4%) 2 (4%) 1 (2%) 2 (4%) Subcutaneous Tissue, Fibroma, Multiple 1 (2%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Cranium, Osteosarcoma 1 (2%) Skeletal Muscle (2) (5) (4) (1) Osteosarcoma 1 (25%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Cerebrum, Oligodendroglioma Malignant 1 (2%) Spinal Cord (2) (3) (3) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Kidney 1 (2%) Chordoma, Metastatic, Uncertain Primary Site 1 (2%) Histiocytic Sarcoma 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Osteosarcoma, Metastatic, Skeletal Muscle 1 (2%) Nose (50) (50) (50) (50) Squamous Cell Carcinoma, Metastatic, Oral Mucosa 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) (1) (2) Adenoma 1 (100%) Carcinoma 1 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Liposarcoma 1 (2%) Renal Tubule, Adenoma 4 (8%) 2 (4%) 6 (12%) Renal Tubule, Carcinoma 1 (2%) 1 (2%) 2 (4%) Renal Tubule, Oncocytoma Benign 1 (2%) Transitional Epithelium, Carcinoma 1 (2%) Urinary Bladder (49) (50) (50) (50) Transitional Epithelium, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 31 (62%) 27 (54%) 24 (48%) 29 (58%) Mesothelioma Malignant 2 (4%) 2 (4%) 2 (4%) * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(50) *(50) *(50) *(50) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96 Route: DOSED FEED Time: 03:10:03 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 12000 25000 50000 PPM PPM PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 50 50 50 Total Primary Neoplasms 159 155 157 166 Total Animals with Benign Neoplasms 47 50 49 50 Total Benign Neoplasms 117 116 122 121 Total Animals with Malignant Neoplasms 35 36 31 33 Total Malignant Neoplasms 42 39 35 45 Total Animals with Metastatic Neoplasms 1 2 2 4 Total Metastatic Neoplasm 3 14 2 7 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------