Pathology Tables for Peer Review
The National Toxicology Program
NTP Experiment-Test: 88032-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC OXYMETHOLONE Date: 11/25/97 Route: GAVAGE Time: 07:20:55 53 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: 04/21/94 - 04/22/94 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: 11/25/97 Route: GAVAGE Time: 07:20:55 ____________________________________________________________________________________________________________________________________ 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 2 (20%) 3 (30%) Intestine Large, Cecum (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) Liver (10) (10) (10) (10) Basophilic Focus 4 (40%) 8 (80%) 2 (20%) 7 (70%) Clear Cell Focus 1 (10%) 1 (10%) Eosinophilic Focus 1 (10%) Hepatodiaphragmatic Nodule 1 (10%) 2 (20%) 2 (20%) 1 (10%) Inflammation, Chronic Active 7 (70%) 5 (50%) 6 (60%) 3 (30%) Bile Duct, Hyperplasia 1 (10%) Centrilobular, Vacuolization Cytoplasmic 7 (70%) Mesentery (1) (3) (3) (1) Fat, Inflammation, Chronic Active 1 (100%) 3 (100%) 3 (100%) 1 (100%) Pancreas (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) Acinus, Atrophy 2 (20%) 1 (10%) 1 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (10) (10) (10) (10) Myocardium, Degeneration, Chronic 7 (70%) 8 (80%) 9 (90%) 9 (90%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (10) (10) (10) (10) Accessory Adrenal Cortical Nodule 3 (30%) 2 (20%) 1 (10%) Hyperplasia 1 (10%) Inflammation, Chronic Active 1 (10%) Vacuolization Cytoplasmic 10 (100%) Pituitary Gland (10) (10) (10) (10) 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: 11/25/97 Route: GAVAGE Time: 07:20:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Cyst 2 (20%) 1 (10%) Pars Distalis, Angiectasis 1 (10%) Thyroid Gland (10) (10) (10) (10) Ultimobranchial Cyst 1 (10%) Follicle, Cyst 1 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (10) (10) (10) (10) Cyst 1 (10%) Inflammation, Chronic Active 4 (40%) 6 (60%) 6 (60%) 3 (30%) Ovary (10) (10) (10) (10) DYSGENESIS 10 (100%) 10 (100%) Follicle, Cyst 1 (10%) Periovarian Tissue, Cyst 1 (10%) Uterus (10) (10) (10) (10) Hydrometra 1 (10%) 1 (10%) Endometrium, Cyst 1 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (10) (10) (10) (10) Myelofibrosis 1 (10%) Spleen (10) (10) (10) (10) Lymphoid Follicle, Depletion Cellular 1 (10%) Thymus (10) (10) (9) (10) Atrophy 2 (20%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (10) (10) (10) (10) Dilatation 1 (10%) 8 (80%) Lobular, Hyperplasia 10 (100%) 8 (80%) ____________________________________________________________________________________________________________________________________ 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: 11/25/97 Route: GAVAGE Time: 07:20:55 ____________________________________________________________________________________________________________________________________ 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) Hemorrhage 1 (10%) 1 (10%) Inflammation, Chronic Active 1 (10%) 4 (40%) 3 (30%) Mineralization 2 (20%) 2 (20%) 2 (20%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) Mineralization 9 (90%) 10 (100%) 10 (100%) 10 (100%) Nephropathy 5 (50%) 6 (60%) 9 (90%) 10 (100%) Urinary Bladder (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) 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: 11/25/97 Route: GAVAGE Time: 07:20:55 ____________________________________________________________________________________________________________________________________ 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 9 10 10 10 Early Deaths Survivors Animals Examined Microscopically 9 10 10 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (9) (10) (10) (10) Parasite Metazoan 4 (40%) 1 (10%) Intestine Large, Cecum (9) (10) (10) (10) Parasite Metazoan 1 (10%) Intestine Small, Ileum (9) (10) (10) (10) Peyer's Patch, Mineralization 1 (10%) Liver (9) (10) (9) (10) Basophilic Focus 2 (20%) 2 (22%) Clear Cell Focus 1 (10%) Cyst 1 (11%) Hepatodiaphragmatic Nodule 2 (22%) 1 (10%) 1 (11%) 1 (10%) Inflammation, Chronic Active 6 (67%) 7 (70%) 6 (67%) Necrosis 4 (40%) 2 (22%) Bile Duct, Hyperplasia 3 (33%) 5 (50%) 3 (33%) Centrilobular, Vacuolization Cytoplasmic 2 (22%) 3 (30%) 1 (11%) Mesentery (1) Fat, Inflammation, Chronic Active 1 (100%) Pancreas (9) (10) (10) (10) Acinus, Atrophy 1 (11%) 3 (30%) 4 (40%) 3 (30%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (9) (10) (10) (10) Myocardium, Degeneration, Chronic 8 (89%) 9 (90%) 10 (100%) 10 (100%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (9) (10) (10) (10) Accessory Adrenal Cortical Nodule 1 (11%) 1 (10%) Hypertrophy 1 (11%) Vacuolization Cytoplasmic 9 (100%) 7 (70%) 9 (90%) 8 (80%) Pituitary Gland (9) (10) (10) (10) Cyst 1 (11%) 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: 11/25/97 Route: GAVAGE Time: 07:20:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 1 (11%) 4 (40%) 3 (30%) 1 (10%) Pars Nervosa, Developmental Malformation 1 (11%) Thyroid Gland (9) (10) (10) (10) Ultimobranchial Cyst 1 (10%) 1 (10%) 1 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (9) (10) (10) (10) Inflammation, Chronic Active 6 (67%) 6 (60%) 9 (90%) 7 (70%) Testes (9) (10) (10) (10) Degeneration 1 (10%) Mineralization 2 (20%) 3 (30%) 6 (60%) Interstitial Cell, Hyperplasia 8 (89%) 7 (70%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (9) (10) (10) (10) Congestion 1 (11%) 1 (10%) 1 (10%) Ectasia 1 (11%) Lymph Node, Mesenteric (9) (10) (10) (10) Atrophy 1 (10%) Spleen (9) (10) (10) (10) Red Pulp, Depletion Cellular 1 (11%) Thymus (9) (10) (10) (10) Atrophy 7 (70%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (8) (9) (10) (10) Dilatation 4 (50%) 1 (11%) 5 (50%) 10 (100%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ 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: 11/25/97 Route: GAVAGE Time: 07:20:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (9) (10) (10) (10) Hemorrhage 1 (11%) 1 (10%) 1 (10%) Inflammation, Chronic Active 1 (11%) 3 (30%) 1 (10%) 2 (20%) Mineralization 2 (22%) 1 (10%) 4 (40%) 4 (40%) Vacuolization Cytoplasmic 1 (10%) 2 (20%) Nose (9) (10) (10) (10) Inflammation, Chronic Active 2 (22%) 1 (10%) Inflammation, Suppurative 1 (11%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (9) (10) (10) (10) Mineralization 1 (11%) 9 (90%) Necrosis 1 (10%) Nephropathy 9 (100%) 10 (100%) 10 (100%) 10 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------
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