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: 07:12:38 27 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: 10/21/93 - 10/22/93 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: 07:12:38 ____________________________________________________________________________________________________________________________________ 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, Rectum (10) (10) (10) (10) Parasite Metazoan 1 (10%) Liver (10) (10) (10) (10) Basophilic Focus 1 (10%) Hepatodiaphragmatic Nodule 1 (10%) 5 (50%) 1 (10%) 2 (20%) Inflammation, Chronic Active 2 (20%) 5 (50%) 4 (40%) 2 (20%) Centrilobular, Vacuolization Cytoplasmic 1 (10%) Mesentery (1) (1) Fat, Inflammation, Chronic Active 1 (100%) 1 (100%) Pancreas (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) Acinus, Atrophy 1 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (10) (10) (10) (10) Myocardium, Degeneration, Chronic 5 (50%) 5 (50%) 7 (70%) 10 (100%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (10) (10) (10) (10) Accessory Adrenal Cortical Nodule 3 (30%) 2 (20%) 1 (10%) Thyroid Gland (10) (10) (10) (10) Ultimobranchial Cyst 1 (10%) 1 (10%) 2 (20%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ 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: 07:12:38 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (10) (10) (10) (10) Inflammation, Chronic Active 6 (60%) 7 (70%) 10 (100%) 8 (80%) 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 2 (20%) 3 (30%) 4 (40%) 1 (10%) Endometrium, Cyst 1 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM None ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (10) (10) (10) (10) Dilatation 1 (10%) Lobular, Hyperplasia 10 (100%) 10 (100%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) (10) (10) Hemorrhage 1 (10%) Inflammation, Chronic Active 2 (20%) 4 (40%) 7 (70%) 2 (20%) Mineralization 2 (20%) 4 (40%) 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: 11/25/97 Route: GAVAGE Time: 07:12:38 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 3 MG/KG 30 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) Lens, Mineralization 1 (100%) Retina, Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) Mineralization 10 (100%) 10 (100%) 10 (100%) 9 (90%) Nephropathy 1 (10%) 2 (20%) 7 (70%) 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: 07:12:38 ____________________________________________________________________________________________________________________________________ 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 Small, Duodenum (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) Intestine Small, Jejunum (10) (10) (10) (10) Inflammation, Granulomatous 1 (10%) Peyer's Patch, Mineralization 1 (10%) Liver (10) (10) (10) (10) Hepatodiaphragmatic Nodule 1 (10%) 1 (10%) 1 (10%) 1 (10%) Inflammation, Chronic Active 3 (30%) 1 (10%) 3 (30%) 1 (10%) Bile Duct, Hyperplasia 3 (30%) Centrilobular, Vacuolization Cytoplasmic 1 (10%) Mesentery (1) Fat, Inflammation, Chronic Active 1 (100%) Pancreas (10) (10) (10) (10) Acinus, Atrophy 2 (20%) Vein, Inflammation, Granulomatous 1 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (10) (10) (10) (10) Myocardium, Degeneration, Chronic 10 (100%) 10 (100%) 9 (90%) 10 (100%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (10) (10) (10) (10) Accessory Adrenal Cortical Nodule 1 (10%) 1 (10%) 1 (10%) Vacuolization Cytoplasmic 10 (100%) 8 (80%) 8 (80%) Thyroid Gland (10) (10) (10) (10) Ultimobranchial Cyst 1 (10%) Follicle, Cyst 2 (20%) ____________________________________________________________________________________________________________________________________ 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: 07:12:38 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (10) (10) (10) (10) Inflammation, Chronic Active 1 (10%) Preputial Gland (10) (10) (10) (10) Cyst 1 (10%) Inflammation, Chronic Active 7 (70%) 10 (100%) 9 (90%) 8 (80%) Testes (10) (10) (10) (10) Mineralization 1 (10%) 1 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Spleen (10) (10) (10) (10) Capsule, Hyperplasia 1 (10%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (10) (10) (10) (10) Dilatation 9 (90%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) (10) (10) Inflammation, Chronic Active 2 (20%) 3 (30%) 8 (80%) 3 (30%) Inflammation, Granulomatous 1 (10%) 2 (20%) Mineralization 4 (40%) 4 (40%) 1 (10%) Vacuolization Cytoplasmic 1 (10%) 1 (10%) 1 (10%) Nose (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 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: 07:12:38 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 3 MG/KG 30 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) Mineralization 2 (20%) 1 (10%) 9 (90%) Nephropathy 8 (80%) 7 (70%) 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 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------
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