TDMS Study 05155-03 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) P-NITROBENZOIC ACID NTP Experiment-Test: 05155-03 Report: PEIRPT05 Study Type: CHRONIC Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 Facility: Southern Research Institute Chemical CAS #: 62-23-7 Lock Date: 02/15/92 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: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 21 23 27 26 Natural Death 2 4 2 3 Survivors Terminal Sacrifice 27 23 21 21 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (60) (60) (60) (60) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Intestine Large, Colon (60) (58) (60) (60) Leiomyosarcoma, Metastatic, Uterus 1 (2%) Intestine Large, Cecum (60) (57) (60) (59) Intestine Small, Duodenum (60) (60) (60) (59) Intestine Small, Ileum (60) (57) (60) (58) Liver (60) (60) (60) (60) Hepatocellular Adenoma 2 (3%) Sarcoma, Metastatic, Mesentery 1 (2%) Mesentery (11) (9) (10) (6) Sarcoma 1 (10%) Schwannoma Malignant, Metastatic, Uterus 1 (10%) Pancreas (60) (60) (59) (59) Acinar Cell, Adenoma 1 (2%) Pharynx (1) Palate, Squamous Cell Papilloma 1 (100%) Salivary Glands (60) (60) (60) (60) Stomach, Forestomach (60) (60) (59) (59) Stomach, Glandular (60) (60) (59) (59) Tongue (1) (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (59) (60) (60) (60) Osteosarcoma, Metastatic, Bone 1 (2%) Adrenal Medulla (59) (60) (60) (60) Osteosarcoma, Metastatic, Bone 1 (2%) Pheochromocytoma Benign 2 (3%) 1 (2%) 3 (5%) Islets, Pancreatic (60) (60) (59) (59) Adenoma 1 (2%) Pituitary Gland (60) (60) (59) (59) Osteosarcoma, Metastatic, Bone 1 (2%) Pars Distalis, Adenoma 20 (33%) 29 (48%) 26 (44%) 26 (44%) Pars Distalis, Carcinoma 1 (2%) Pars Nervosa, Ganglioneuroma 1 (2%) Thyroid Gland (60) (59) (60) (60) C-Cell, Adenoma 9 (15%) 4 (7%) 5 (8%) 2 (3%) C-Cell, Adenoma, Multiple 1 (2%) C-Cell, Carcinoma 1 (2%) 2 (3%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (60) (59) (59) (60) Adenoma 4 (7%) 12 (20%) 9 (15%) 11 (18%) Carcinoma 1 (2%) 2 (3%) 4 (7%) 3 (5%) Bilateral, Adenoma 1 (2%) 1 (2%) Bilateral, Carcinoma 1 (2%) 1 (2%) Ovary (60) (60) (60) (59) Granulosa Cell Tumor Benign 1 (2%) Neoplasm NOS 1 (2%) Uterus (60) (60) (60) (59) Histiocytic Sarcoma 1 (2%) Leiomyosarcoma 1 (2%) Endometrium, Polyp Stromal 5 (8%) 13 (22%) 14 (23%) 6 (10%) Endometrium, Polyp Stromal, Multiple 1 (2%) 1 (2%) Endometrium, Sarcoma Stromal 1 (2%) 2 (3%) Endometrium, Schwannoma Malignant 1 (2%) 2 (3%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (14) (14) (11) (10) Renal, Sarcoma, Metastatic, Mesentery 1 (9%) Lymph Node, Mandibular (60) (60) (60) (60) Lymph Node, Mesenteric (59) (60) (60) (59) Spleen (60) (60) (60) (59) Fibrosarcoma 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) Thymus (59) (58) (60) (60) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (60) (60) (60) Adenoma 1 (2%) Carcinoma 2 (3%) 2 (3%) 3 (5%) 2 (3%) Fibroadenoma 17 (28%) 16 (27%) 19 (32%) 19 (32%) Fibroadenoma, Multiple 5 (8%) 7 (12%) 7 (12%) 5 (8%) Skin (60) (60) (60) (60) Basal Cell Carcinoma 1 (2%) Basosquamous Tumor Malignant 1 (2%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 2 (3%) 1 (2%) 3 (5%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Osteosarcoma 1 (2%) 1 (2%) 1 (2%) Skeletal Muscle (1) (1) Rhabdomyosarcoma 1 (100%) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Astrocytoma NOS 1 (2%) Glioma Malignant 1 (2%) Peripheral Nerve (2) (4) (2) Schwannoma Malignant 1 (25%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Osteosarcoma, Multiple, Metastatic, Bone 1 (2%) Squamous Cell Carcinoma 1 (2%) Nose (60) (60) (60) (59) Trachea (60) (60) (60) (60) Carcinoma, Metastatic, Thyroid Gland 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Pelvis, Transitional Epithelium, Mesenchymal Nos 1 (2%) Urinary Bladder (60) (60) (60) (60) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 17 (28%) 12 (20%) 3 (5%) Mesothelioma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 53 55 49 Total Primary Neoplasms 97 109 113 87 Total Animals with Benign Neoplasms 42 46 48 45 Total Benign Neoplasms 70 85 89 76 Total Animals with Malignant Neoplasms 21 20 22 10 Total Malignant Neoplasms 27 22 23 11 Total Animals with Metastatic Neoplasms 2 2 1 Total Metastatic Neoplasm 5 4 3 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 2 1 Total Uncertain Neoplasms 2 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: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 32 34 34 25 Natural Death 6 3 3 4 Survivors Terminal Sacrifice 12 13 13 21 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (59) (60) (59) (59) Polyp Adenomatous 1 (2%) Intestine Large, Rectum (59) (60) (59) (60) Intestine Large, Cecum (59) (60) (59) (60) Hemangiosarcoma 1 (2%) Intestine Small, Duodenum (58) (58) (59) (60) Intestine Small, Jejunum (59) (59) (59) (60) Carcinoma 2 (3%) Intestine Small, Ileum (58) (59) (59) (60) Liver (59) (60) (60) (60) Hepatocellular Carcinoma 3 (5%) 2 (3%) Hepatocellular Adenoma 2 (3%) 2 (3%) 1 (2%) 2 (3%) Hepatocellular Adenoma, Multiple 2 (3%) Osteosarcoma, Metastatic, Bone 1 (2%) Mesentery (18) (14) (15) (20) Carcinoma, Metastatic, Kidney 1 (7%) Schwannoma Malignant, Metastatic, Peripheral Nerve 1 (7%) Pancreas (59) (60) (59) (60) Schwannoma Malignant, Metastatic, Peripheral Nerve 1 (2%) Acinar Cell, Adenoma 2 (3%) 3 (5%) Pharynx (1) (3) Palate, Squamous Cell Papilloma 1 (100%) 2 (67%) Salivary Glands (59) (59) (60) (60) Schwannoma Malignant 1 (2%) 1 (2%) Stomach, Forestomach (60) (60) (60) (60) Stomach, Glandular (60) (59) (59) (60) Leiomyoma 1 (2%) Tongue (2) Squamous Cell Papilloma 1 (50%) Page 7 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Adenoma 1 (2%) Adrenal Medulla (60) (60) (60) (60) Pheochromocytoma Malignant 2 (3%) 1 (2%) 2 (3%) Pheochromocytoma Benign 8 (13%) 7 (12%) 6 (10%) 11 (18%) Bilateral, Pheochromocytoma Benign 2 (3%) 4 (7%) 2 (3%) 1 (2%) Islets, Pancreatic (59) (60) (59) (60) Adenoma 2 (3%) 1 (2%) 2 (3%) Carcinoma 1 (2%) Parathyroid Gland (57) (59) (57) (59) Pituitary Gland (59) (60) (59) (59) Pars Distalis, Adenoma 20 (34%) 14 (23%) 20 (34%) 13 (22%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (59) (59) (59) (60) C-Cell, Adenoma 4 (7%) 2 (3%) 2 (3%) 3 (5%) C-Cell, Carcinoma 1 (2%) 3 (5%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (2) (2) (2) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (59) (60) Preputial Gland (60) (60) (59) (60) Adenoma 4 (7%) 2 (3%) 5 (8%) 4 (7%) Carcinoma 1 (2%) 1 (2%) 3 (5%) 5 (8%) Bilateral, Adenoma 1 (2%) Bilateral, Carcinoma 1 (2%) 1 (2%) Duct, Squamous Cell Papilloma 1 (2%) Prostate (60) (60) (60) (60) Seminal Vesicle (60) (60) (59) (60) Schwannoma Malignant, Metastatic, Peripheral Nerve 1 (2%) Testes (60) (60) (59) (60) Bilateral, Interstitial Cell, Adenoma 38 (63%) 43 (72%) 42 (71%) 21 (35%) Page 8 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Interstitial Cell, Adenoma 15 (25%) 10 (17%) 11 (19%) 16 (27%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (26) (26) (32) (15) Mediastinal, Carcinoma, Metastatic, Kidney 1 (3%) Pancreatic, Carcinoma, Metastatic, Kidney 1 (3%) Renal, Carcinoma, Metastatic, Kidney 1 (3%) Lymph Node, Mandibular (59) (59) (59) (60) Lymph Node, Mesenteric (59) (60) (59) (60) Carcinoma, Metastatic, Kidney 1 (2%) Spleen (60) (60) (60) (60) Fibrosarcoma 1 (2%) Histiocytic Sarcoma 2 (3%) Thymus (57) (59) (58) (56) Epithelial Cell, Thymoma Benign 1 (2%) 1 (2%) 2 (3%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (59) (57) (58) (54) Fibroadenoma 3 (5%) 1 (2%) 4 (7%) 2 (4%) Skin (60) (60) (60) (60) Basal Cell Adenoma 1 (2%) 1 (2%) Keratoacanthoma 3 (5%) 3 (5%) 3 (5%) 2 (3%) Squamous Cell Papilloma 2 (3%) Trichoepithelioma 1 (2%) Subcutaneous Tissue, Fibroma 4 (7%) 6 (10%) 4 (7%) 7 (12%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 4 (7%) Subcutaneous Tissue, Lipoma 1 (2%) 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Osteosarcoma 2 (3%) 1 (2%) 1 (2%) Skeletal Muscle (1) (1) (1) Schwannoma Malignant, Metastatic, Peripheral Nerve 1 (100%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Glioma Malignant 1 (2%) Peripheral Nerve (2) (5) (1) Schwannoma Malignant 1 (50%) 1 (20%) Spinal Cord (2) (4) (2) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Alveolar/Bronchiolar Adenoma 1 (2%) 3 (5%) Alveolar/Bronchiolar Carcinoma 1 (2%) Carcinoma, Multiple, Metastatic, Kidney 1 (2%) Osteosarcoma, Multiple, Metastatic, Bone 1 (2%) 1 (2%) Squamous Cell Carcinoma 1 (2%) Nose (60) (60) (60) (60) Nasolacrimal Duct, Squamous Cell Carcinoma 1 (2%) Trachea (59) (59) (60) (60) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) Pinna, Fibrosarcoma 1 (100%) Zymbal's Gland (2) Adenoma 1 (50%) Carcinoma 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Pelvis, Transitional Epithelium, Papilloma 1 (2%) Renal Tubule, Adenoma 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (60) (60) (59) (60) Leiomyosarcoma 1 (2%) Schwannoma Malignant, Metastatic, Peripheral Nerve 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Histiocytic Sarcoma 2 (3%) * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(60) *(60) *(60) *(60) Leukemia Mononuclear 29 (48%) 36 (60%) 26 (43%) 2 (3%) Mesothelioma Benign 1 (2%) Mesothelioma Malignant 2 (3%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 05155-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC P-NITROBENZOIC ACID Date: 05/08/95 Route: DOSED FEED Time: 17:03:39 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0.0% 0.125% 0.25% 0.5% ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 57 59 59 50 Total Primary Neoplasms 158 149 155 113 Total Animals with Benign Neoplasms 56 57 58 45 Total Benign Neoplasms 111 104 117 89 Total Animals with Malignant Neoplasms 39 39 34 20 Total Malignant Neoplasms 47 45 38 24 Total Animals with Metastatic Neoplasms 1 2 2 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------