TDMS Study 05035-02 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) 4-HYDROXYACETANILIDE NTP Experiment-Test: 05035-02 Report: PEIRPT05 Study Type: CHRONIC Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 Facility: TSI Mason Research Chemical CAS #: 103-90-2 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: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF UF ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund 21 9 21 8 Dead 2 9 4 Accident 4 Survivors Terminal Sacrifice 27 32 25 38 Animals Examined Microscopically 50 50 50 51 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (42) (45) (44) (46) Intestine Large, Cecum (49) (45) (49) (48) Sarcoma 1 (2%) Intestine Small, Duodenum (48) (44) (47) (50) Hemangiosarcoma 1 (2%) Intestine Small, Ileum (48) (43) (48) (47) Intestine Small, Jejunum (47) (42) (46) (48) Adenocarcinoma 1 (2%) Liver (49) (50) (50) (49) Hemangiosarcoma 1 (2%) Hemangiosarcoma, Metastatic, Intestine Small 1 (2%) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 3 (6%) 4 (8%) 7 (14%) 2 (4%) Histiocytic Sarcoma 1 (2%) 1 (2%) Mesentery (4) (4) (3) (1) Pancreas (49) (48) (47) (49) Salivary Glands (46) (49) (50) (50) Stomach, Forestomach (48) (49) (49) (48) Stomach, Glandular (47) (47) (50) (48) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF UF ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (49) (46) (49) Adrenal Gland, Medulla (46) (46) (45) (47) Pheochromocytoma Malignant 1 (2%) Islets, Pancreatic (48) (47) (43) (49) Adenoma 1 (2%) Carcinoma 1 (2%) Pituitary Gland (46) (43) (42) (45) Pars Distalis, Adenoma 14 (30%) 16 (37%) 7 (17%) 14 (31%) Pars Distalis, Carcinoma 1 (2%) 1 (2%) 1 (2%) Pars Intermedia, Adenoma 1 (2%) Thyroid Gland (48) (50) (50) (50) Follicular Cell, Adenoma 1 (2%) 1 (2%) 2 (4%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (47) (49) (49) (50) Cystadenoma 2 (4%) 1 (2%) Hemangioma 1 (2%) Uterus (49) (50) (50) (49) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) 1 (2%) Histiocytic Sarcoma 1 (2%) Polyp Stromal 1 (2%) 1 (2%) 1 (2%) Endometrium, Adenocarcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (49) (49) (49) Lymph Node (49) (47) (49) (49) Lymph Node, Mandibular (41) (26) (29) (44) Histiocytic Sarcoma 1 (2%) Lymph Node, Mesenteric (44) (45) (45) (43) Histiocytic Sarcoma 1 (2%) 1 (2%) Spleen (49) (50) (50) (49) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) Histiocytic Sarcoma 1 (2%) Thymus (23) (30) (30) (34) Page 3 NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF UF ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (25) (20) (28) (17) Adenoacanthoma 1 (5%) Adenocarcinoma 1 (4%) 1 (6%) Skin (47) (48) (49) (48) Hemangiosarcoma 1 (2%) Melanoma Malignant 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma, Multiple 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 4 (8%) 4 (8%) 4 (8%) Carcinoma, Metastatic 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Nose (47) (44) (45) (38) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (1) Carcinoma, Metastatic 1 (100%) Harderian Gland (5) (2) (2) (2) Adenoma 4 (80%) 2 (100%) 1 (50%) 2 (100%) Carcinoma 1 (20%) 1 (50%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF UF ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (49) (50) (49) Histiocytic Sarcoma 1 (2%) Urinary Bladder (49) (46) (44) (46) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(51) Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%) 1 (2%) Leukemia 1 (2%) 1 (2%) Lymphoma Malignant 1 (2%) Lymphoma Malignant Histiocytic 1 (2%) Lymphoma Malignant Lymphocytic 2 (4%) 3 (6%) 3 (6%) Lymphoma Malignant Mixed 8 (16%) 6 (12%) 7 (14%) 13 (25%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF UF ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 35 28 24 35 Total Primary Neoplasms 45 48 37 49 Total Animals with Benign Neoplasms 22 22 17 22 Total Benign Neoplasms 24 32 22 26 Total Animals with Malignant Neoplasms 20 15 14 19 Total Malignant Neoplasms 21 16 15 23 Total Animals with Metastatic Neoplasms 1 1 2 1 Total Metastatic Neoplasm 1 1 3 1 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: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM UM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund 13 3 16 10 Dead 5 7 3 9 Survivors Terminal Sacrifice 32 40 31 31 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (41) (43) (47) (40) Intestine Small, Duodenum (48) (42) (49) (45) Adenocarcinoma 1 (2%) Intestine Small, Ileum (48) (45) (48) (44) Intestine Small, Jejunum (47) (43) (47) (45) Adenocarcinoma 1 (2%) 2 (4%) Liver (50) (50) (50) (50) Cholangiocarcinoma 1 (2%) Hemangiosarcoma 2 (4%) 1 (2%) 2 (4%) 1 (2%) Hepatocellular Carcinoma 7 (14%) 1 (2%) 6 (12%) 3 (6%) Hepatocellular Adenoma 11 (22%) 8 (16%) 5 (10%) 4 (8%) Histiocytic Sarcoma 1 (2%) 1 (2%) Pancreas (47) (49) (50) (48) Salivary Glands (50) (49) (50) (49) Stomach, Forestomach (49) (49) (50) (49) Squamous Cell Papilloma 1 (2%) 3 (6%) 2 (4%) Stomach, Glandular (50) (47) (49) (48) Adenocarcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM UM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (50) (48) (49) (49) Capsule, Adenoma 1 (2%) Subcapsular, Adenoma 1 (2%) Adrenal Gland, Cortex (50) (48) (49) (49) Adrenal Gland, Medulla (47) (48) (48) (48) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 4 (8%) 1 (2%) 1 (2%) Pituitary Gland (48) (39) (39) (46) Thyroid Gland (49) (49) (50) (50) Follicular Cell, Adenoma 2 (4%) 1 (2%) 1 (2%) 1 (2%) Follicular Cell, Adenoma, Multiple 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Prostate (48) (42) (47) (48) Seminal Vesicle (49) (49) (49) (50) Testes (50) (50) (50) (50) Interstitial Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (50) (49) Lymph Node (49) (47) (47) (47) Axillary, Fibrosarcoma, Metastatic 1 (2%) Mediastinal, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (2%) Renal, Histiocytic Sarcoma 1 (2%) Lymph Node, Mandibular (43) (20) (17) (40) Lymph Node, Mesenteric (43) (45) (47) (42) Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma 1 (2%) Spleen (50) (50) (49) (48) Hemangioma 1 (2%) Hemangiosarcoma 2 (4%) Histiocytic Sarcoma 1 (2%) Thymus (11) (18) (28) (22) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM UM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (48) (49) (50) (50) Basal Cell Carcinoma 1 (2%) Hemangioma 1 (2%) Hemangiosarcoma 1 (2%) Squamous Cell Papilloma 1 (2%) 2 (4%) Trichoepithelioma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 5 (10%) 5 (10%) 3 (6%) 6 (12%) Subcutaneous Tissue, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Peripheral Nerve (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Alveolar/Bronchiolar Adenoma 8 (16%) 5 (10%) 5 (10%) 9 (18%) Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 2 (4%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%) Hemangiosarcoma, Metastatic, Liver 1 (2%) Hepatocellular Carcinoma, Metastatic, Liver 2 (4%) 2 (4%) 2 (4%) Nose (47) (40) (46) (44) Squamous Cell Papilloma 1 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Neurofibroma 1 (100%) Harderian Gland (4) (3) (4) (3) Adenoma 4 (100%) 2 (67%) 3 (75%) 3 (100%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM UM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (50) (50) Histiocytic Sarcoma 1 (2%) Renal Tubule, Adenoma 1 (2%) 1 (2%) Urinary Bladder (47) (46) (46) (45) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) 1 (2%) Lymphoma Malignant Lymphocytic 1 (2%) 1 (2%) Lymphoma Malignant Mixed 6 (12%) 3 (6%) 2 (4%) 2 (4%) Lymphoma Malignant Undifferentiated Cell 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94 Route: DOSED FEED Time: 22:25:10 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM UM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 35 29 31 28 Total Primary Neoplasms 56 41 46 37 Total Animals with Benign Neoplasms 23 22 21 20 Total Benign Neoplasms 29 25 28 22 Total Animals with Malignant Neoplasms 25 14 17 13 Total Malignant Neoplasms 27 16 18 15 Total Animals with Metastatic Neoplasms 4 3 6 Total Metastatic Neoplasm 5 3 6 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 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