TDMS Study 88032-05 Pathology Tables
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97 Route: GAVAGE Time: 11:06:56 79 WEEK SSAC Facility: Battelle Columbus Laboratory Chemical CAS #: 434-07-01 Lock Date: 01/02/96 Cage Range: All Reasons For Removal: 25017 Scheduled Sacrifice Removal Date Range: 10/20/94 - 10/21/94 Treatment Groups: Include 002 0 MG/KG Include 004 3 MG/KG Include 006 30 MG/KG Include 008 100 MG/KG Include 001 0 MG/KG Include 003 3 MG/KG Include 005 30 MG/KG Include 007 150 MG/KG a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97 Route: GAVAGE Time: 11:06:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 90 90 90 90 Scheduled Sacrifice 10 10 10 10 Early Deaths Survivors Animals Examined Microscopically 10 10 10 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (10) (10) (10) (10) Parasite Metazoan 1 (10%) Intestine Large, Rectum (10) (10) (10) (10) Parasite Metazoan 4 (40%) 4 (40%) 4 (40%) Liver (10) (10) (10) (10) Basophilic Focus 7 (70%) 10 (100%) 10 (100%) 9 (90%) Clear Cell Focus 1 (10%) 3 (30%) Hepatodiaphragmatic Nodule 2 (20%) 1 (10%) 2 (20%) 1 (10%) Inflammation, Chronic Active 7 (70%) 6 (60%) 7 (70%) 1 (10%) Mixed Cell Focus 2 (20%) Bile Duct, Hyperplasia 1 (10%) Centrilobular, Vacuolization Cytoplasmic 9 (90%) 1 (10%) Mesentery (4) (3) (2) (1) Fat, Inflammation, Chronic Active 4 (100%) 3 (100%) 2 (100%) 1 (100%) Fat, Mineralization 1 (25%) Pancreas (10) (10) (10) (10) Acinus, Atrophy 1 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (10) (10) (10) (10) Myocardium, Degeneration, Chronic 6 (60%) 7 (70%) 8 (80%) 9 (90%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (10) (10) (10) (10) Angiectasis 3 (30%) Vacuolization Cytoplasmic 1 (10%) 9 (90%) Adrenal Medulla (10) (10) (10) (10) Hyperplasia 1 (10%) Pituitary Gland (10) (9) (10) (10) Cyst 2 (20%) 1 (11%) 2 (20%) 1 (10%) Hyperplasia 1 (10%) 1 (11%) 2 (20%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97 Route: GAVAGE Time: 11:06:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Thyroid Gland (10) (10) (10) (10) C-Cell, Hyperplasia 1 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (9) (10) (8) (10) Cyst 3 (30%) Inflammation, Chronic Active 5 (56%) 3 (30%) 2 (25%) 4 (40%) Ovary (10) (10) (10) (10) DYSGENESIS 8 (80%) 10 (100%) Periovarian Tissue, Cyst 3 (30%) 1 (10%) 1 (10%) 1 (10%) Uterus (10) (10) (10) (10) Hydrometra 3 (30%) 2 (20%) Endometrium, Cyst 1 (10%) Endometrium, Hyperplasia 1 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (10) (10) (10) (10) Ectasia 1 (10%) Lymph Node, Mesenteric (10) (10) (10) (10) Ectasia 1 (10%) Spleen (10) (10) (10) (10) Hematopoietic Cell Proliferation 1 (10%) Pigmentation, Hemosiderin 1 (10%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (10) (10) (10) (10) Dilatation 4 (40%) 1 (10%) 1 (10%) Galactocele 1 (10%) 1 (10%) Lobular, Hyperplasia 1 (10%) 9 (90%) 9 (90%) Skin (10) (10) (10) (10) Epidermis, Cyst 1 (10%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97 Route: GAVAGE Time: 11:06:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) 4 (40%) 4 (40%) 3 (30%) Mineralization 2 (20%) 1 (10%) 5 (50%) 3 (30%) Nose (10) (10) (10) (10) Inflammation, Suppurative 1 (10%) Glands, Hyperplasia 1 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) Mineralization 8 (80%) 9 (90%) 10 (100%) 9 (90%) Nephropathy 8 (80%) 4 (40%) 9 (90%) 10 (100%) Renal Tubule, Hyperplasia 1 (10%) Urinary Bladder (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) 2 (20%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97 Route: GAVAGE Time: 11:06:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 90 90 90 90 Scheduled Sacrifice 10 10 10 10 Early Deaths Survivors Animals Examined Microscopically 10 10 10 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (10) (10) (10) (10) Parasite Metazoan 1 (10%) 1 (10%) Intestine Large, Rectum (10) (10) (10) (10) Parasite Metazoan 2 (20%) 4 (40%) 1 (10%) 1 (10%) Intestine Small, Ileum (10) (10) (10) (10) Fibrosis 1 (10%) Liver (10) (10) (10) (10) Basophilic Focus 4 (40%) 8 (80%) 9 (90%) 8 (80%) Clear Cell Focus 2 (20%) 2 (20%) 2 (20%) Degeneration, Cystic 1 (10%) Eosinophilic Focus 1 (10%) 1 (10%) 1 (10%) Hepatodiaphragmatic Nodule 2 (20%) 1 (10%) 1 (10%) Inflammation, Chronic Active 8 (80%) 5 (50%) 1 (10%) Mixed Cell Focus 1 (10%) 3 (30%) Necrosis 1 (10%) Bile Duct, Hyperplasia 10 (100%) 6 (60%) 6 (60%) Centrilobular, Vacuolization Cytoplasmic 3 (30%) 5 (50%) 2 (20%) 1 (10%) Mesentery (3) (1) (3) Fat, Congestion 1 (33%) Fat, Inflammation, Chronic Active 2 (67%) 1 (100%) 3 (100%) Fat, Mineralization 1 (33%) Pancreas (10) (10) (10) (10) Acinus, Atrophy 1 (10%) 2 (20%) 2 (20%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (10) (10) (10) (10) Myocardium, Degeneration, Chronic 10 (100%) 10 (100%) 10 (100%) 10 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97 Route: GAVAGE Time: 11:06:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (10) (10) (10) (10) Vacuolization Cytoplasmic 4 (40%) 8 (80%) 10 (100%) 10 (100%) Adrenal Medulla (10) (10) (10) (10) Hyperplasia 3 (30%) 1 (10%) 2 (20%) Islets, Pancreatic (10) (10) (10) (10) Pigmentation, Hemosiderin 1 (10%) Pituitary Gland (10) (10) (10) (9) Atrophy 1 (10%) Cyst 2 (20%) Hyperplasia 2 (20%) 3 (30%) 2 (20%) 1 (11%) Thyroid Gland (10) (10) (10) (10) C-Cell, Hyperplasia 1 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (10) (10) (10) (10) Degeneration 1 (10%) Preputial Gland (10) (10) (10) (10) Inflammation, Chronic Active 10 (100%) 8 (80%) 9 (90%) 8 (80%) Prostate (10) (10) (10) (10) Inflammation, Chronic Active 2 (20%) 2 (20%) Seminal Vesicle (10) (10) (10) (10) Cyst 1 (10%) Testes (10) (10) (10) (10) Degeneration 2 (20%) 1 (10%) 2 (20%) 3 (30%) Mineralization 3 (30%) 1 (10%) 7 (70%) 4 (40%) Interstitial Cell, Hyperplasia 3 (30%) 4 (40%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (10) (10) (10) (10) Myelofibrosis 1 (10%) 1 (10%) Lymph Node, Mandibular (10) (10) (10) (10) Ectasia 1 (10%) Spleen (10) (10) (10) (10) Hematopoietic Cell Proliferation 1 (10%) Thymus (10) (10) (9) (10) Atrophy 2 (20%) 1 (10%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97 Route: GAVAGE Time: 11:06:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (10) (10) (10) (10) Dilatation 2 (20%) 3 (30%) 1 (10%) 7 (70%) Galactocele 2 (20%) 1 (10%) Lobular, Hyperplasia 6 (60%) Skin (10) (10) (10) (10) Parakeratosis 1 (10%) Ulcer 1 (10%) Epidermis, Cyst 1 (10%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) (9) (10) Inflammation, Chronic Active 4 (40%) 3 (33%) Mineralization 1 (10%) 4 (40%) 6 (67%) 3 (30%) Vacuolization Cytoplasmic 1 (10%) 3 (30%) 1 (11%) 2 (20%) Alveolar Epithelium, Hyperplasia 1 (10%) Nose (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) Inflammation, Suppurative 1 (10%) 2 (20%) 1 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) Mineralization 4 (40%) Nephropathy 10 (100%) 10 (100%) 9 (90%) 10 (100%) Pigmentation, Hemosiderin 1 (10%) Urinary Bladder (10) (10) (10) (10) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/24/97 Route: GAVAGE Time: 11:06:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Inflammation, Chronic Active 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------