TDMS Study 05187-09 Pathology Tables
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 CORE STUDY Facility: Battelle Columbus Laboratory Chemical CAS #: 93-15-2 Lock Date: 09/17/96 Cage Range: All Reasons For Removal: 25022 Accidently Killed 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice 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: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 50 50 50 60 Early Deaths Natural Death 11 9 13 12 9 Moribund Sacrifice 17 16 14 26 25 Accidently Killed 1 Dosing Accident 1 Survivors Terminal Sacrifice 22 25 22 11 16 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (50) (50) (50) Parasite Metazoan 1 (2%) 1 (2%) Ulcer 1 (2%) Intestine Large, Rectum (50) (50) (50) (50) (50) Parasite Metazoan 2 (4%) 4 (8%) 2 (4%) 2 (4%) Intestine Large, Cecum (50) (50) (50) (50) (50) Lymphoid Tissue, Hyperplasia 1 (2%) Intestine Small, Duodenum (50) (50) (50) (50) (50) Ulcer 1 (2%) Liver (50) (50) (49) (49) (50) Basophilic Focus 36 (72%) 36 (72%) 29 (59%) 17 (35%) 10 (20%) Clear Cell Focus 3 (6%) 10 (20%) 12 (24%) 4 (8%) 7 (14%) Degeneration, Cystic, Focal 1 (2%) 4 (8%) 29 (58%) Eosinophilic Focus 10 (20%) 20 (40%) 27 (55%) 31 (63%) 37 (74%) Hepatodiaphragmatic Nodule 7 (14%) 2 (4%) 6 (12%) 2 (4%) 3 (6%) Inflammation, Granulomatous 1 (2%) Mixed Cell Focus 6 (12%) 4 (8%) 19 (39%) 9 (18%) 7 (14%) Necrosis, Focal 1 (2%) 1 (2%) 1 (2%) Bile Duct, Cyst 2 (4%) Bile Duct, Hyperplasia 11 (22%) 11 (22%) 17 (35%) 22 (45%) 30 (60%) Centrilobular, Degeneration, Fatty 3 (6%) Centrilobular, Necrosis 1 (2%) 1 (2%) Centrilobular, Necrosis, Acute 1 (2%) Hepatocyte, Hypertrophy 1 (2%) 13 (26%) 16 (33%) 26 (53%) 31 (62%) Oval Cell, Hyperplasia 1 (2%) 15 (30%) 19 (39%) 35 (71%) 34 (68%) Periportal, Degeneration, Fatty 1 (2%) Mesentery (6) (5) (3) (3) (3) Inflammation, Chronic 1 (33%) Artery, Inflammation, Chronic 1 (17%) Fat, Fibrosis 1 (33%) Fat, Necrosis 5 (83%) 5 (100%) 2 (67%) 3 (100%) 2 (67%) Oral Mucosa (1) (1) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hyperplasia, Focal 1 (100%) Pancreas (50) (50) (50) (49) (50) Fibrosis 1 (2%) Hyperplasia, Focal 1 (2%) Acinus, Atrophy 10 (20%) 11 (22%) 8 (16%) 6 (12%) 4 (8%) Salivary Glands (50) (48) (49) (49) (50) Submandibular Gland, Cytoplasmic Alteration 1 (2%) 48 (100%) 49 (100%) 49 (100%) 49 (98%) Stomach, Forestomach (50) (49) (50) (50) (50) Hyperkeratosis, Diffuse 1 (2%) Ulcer 2 (4%) Stomach, Glandular (50) (50) (50) (48) (49) Atrophy 3 (6%) 41 (82%) 45 (90%) 39 (81%) 33 (67%) Mineralization 1 (2%) Ulcer 3 (6%) 4 (8%) 4 (8%) 3 (6%) Neuroendocrine Cell, Hyperplasia 5 (10%) 11 (22%) 9 (19%) 3 (6%) Tongue (1) (1) Hyperkeratosis, Focal 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) (50) Aorta, Mineralization 1 (2%) Heart (50) (50) (49) (49) (50) Degeneration, Mucoid 1 (2%) Atrium, Thrombosis 2 (4%) 1 (2%) Myocardium, Degeneration 35 (70%) 30 (60%) 26 (53%) 20 (41%) 27 (54%) Valve, Fibrosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (49) (50) Hyperplasia, Focal 13 (26%) 11 (22%) 7 (14%) 9 (18%) 5 (10%) Necrosis 2 (4%) 1 (2%) Bilateral, Hyperplasia 1 (2%) Adrenal Medulla (50) (50) (50) (49) (50) Hyperplasia, Focal 4 (8%) 9 (18%) 4 (8%) 3 (6%) 6 (12%) Infarct 1 (2%) Islets, Pancreatic (50) (50) (50) (50) (50) Hyperplasia 1 (2%) 1 (2%) Parathyroid Gland (44) (45) (41) (46) (45) Hyperplasia 3 (7%) Bilateral, Hyperplasia 1 (2%) Pituitary Gland (50) (50) (50) (50) (49) Angiectasis 4 (8%) 2 (4%) 2 (4%) 2 (4%) Cyst 3 (6%) 2 (4%) 4 (8%) 2 (4%) 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Distalis, Hyperplasia, Diffuse 1 (2%) Pars Distalis, Hyperplasia, Focal 11 (22%) 17 (34%) 14 (28%) 15 (30%) 6 (12%) Pars Intermedia, Hyperplasia, Focal 1 (2%) Rathke's Cleft, Cyst 1 (2%) Thyroid Gland (50) (49) (49) (50) (48) Inflammation, Focal, Suppurative 1 (2%) C-Cell, Hyperplasia 32 (64%) 33 (67%) 30 (61%) 32 (64%) 32 (67%) Follicle, Cyst 1 (2%) 1 (2%) Follicular Cell, Hyperplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (46) (49) (46) (48) Cyst 2 (4%) 1 (2%) 2 (4%) 1 (2%) Hyperplasia, Focal 2 (4%) 3 (7%) 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) Necrosis, Focal 1 (2%) Ovary (50) (50) (49) (49) (50) Cyst 2 (4%) 7 (14%) 2 (4%) 2 (4%) 4 (8%) Uterus (50) (50) (49) (50) (50) Hyperplasia, Cystic 2 (4%) Cervix, Hyperplasia, Focal 1 (2%) Endometrium, Degeneration 1 (2%) Endometrium, Hyperplasia, Cystic 1 (2%) Vagina (2) (2) Infiltration Cellular, Polymorphonuclear 1 (50%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) (50) Fibrosis 2 (4%) 2 (4%) 2 (4%) 4 (8%) Hyperplasia 4 (8%) 15 (30%) 11 (22%) 20 (40%) 25 (50%) Inflammation, Granulomatous 2 (4%) Necrosis 1 (2%) 2 (4%) Erythroid Cell, Hyperplasia 1 (2%) Myeloid Cell, Hyperplasia 1 (2%) 2 (4%) Lymph Node (2) (5) (1) (10) (6) Pancreatic, Erythrophagocytosis 1 (50%) Pancreatic, Hyperplasia 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Pancreatic, Necrosis 1 (20%) Renal, Ectasia 1 (10%) Renal, Inflammation, Granulomatous 1 (17%) Lymph Node, Mandibular (49) (48) (49) (49) (48) Necrosis 1 (2%) Lymph Node, Mesenteric (50) (49) (49) (49) (50) Erythrophagocytosis 1 (2%) Inflammation, Granulomatous 1 (2%) Necrosis 1 (2%) Spleen (50) (50) (50) (49) (50) Fibrosis 3 (6%) 3 (6%) 5 (10%) 12 (24%) 15 (30%) Hematopoietic Cell Proliferation 7 (14%) 6 (12%) 2 (4%) 12 (24%) Inflammation, Focal, Suppurative 1 (2%) Inflammation, Granulomatous 2 (4%) 1 (2%) 1 (2%) Necrosis 1 (2%) Lymphoid Follicle, Hyperplasia 1 (2%) Red Pulp, Necrosis 2 (4%) Thymus (49) (48) (46) (46) (49) Atrophy 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) (50) Dilatation 27 (54%) 22 (44%) 34 (68%) 20 (40%) 10 (20%) Galactocele 10 (20%) 10 (20%) 7 (14%) 6 (12%) 5 (10%) Hyperplasia, Cystic 2 (4%) 2 (4%) Hyperplasia, Focal 8 (16%) 7 (14%) 9 (18%) 2 (4%) 2 (4%) Hyperplasia, Lobular 1 (2%) Inflammation, Suppurative 1 (2%) Skin (50) (50) (50) (50) (50) Ulcer 1 (2%) Dermis, Necrosis 1 (2%) Dermis, Subcutaneous Tissue, Fibrosis 1 (2%) 1 (2%) Hair Follicle, Atrophy, Focal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) Fibrous Osteodystrophy 3 (6%) Hyperostosis 1 (2%) 1 (2%) 5 (10%) 4 (8%) 2 (4%) Osteopetrosis 1 (2%) 2 (4%) Skeletal Muscle (1) (1) (1) Degeneration, Focal 1 (100%) Fibrosis 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) Congestion, Focal 1 (2%) Hydrocephalus 4 (8%) 9 (18%) 3 (6%) 8 (16%) 9 (18%) Cerebellum, Necrosis, Focal 1 (2%) Hypothalamus, Degeneration 9 (18%) 12 (24%) 6 (12%) 7 (14%) 5 (10%) Medulla, Degeneration 1 (2%) Pons, Degeneration 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (49) (49) (50) Inflammation, Acute 1 (2%) 2 (4%) Inflammation, Chronic 1 (2%) Inflammation, Granulomatous 1 (2%) 1 (2%) 2 (4%) Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 3 (6%) 7 (14%) 3 (6%) 5 (10%) Interstitium, Inflammation, Chronic 1 (2%) 1 (2%) Interstitium, Mineralization 2 (4%) Nose (50) (50) (50) (50) (50) Hyperplasia, Squamous 1 (2%) Inflammation, Suppurative 8 (16%) 10 (20%) 14 (28%) 3 (6%) 3 (6%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (2) Cataract 1 (100%) 1 (50%) Degeneration 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) (50) Hydronephrosis 2 (4%) Infarct 3 (6%) 1 (2%) Inflammation, Focal, Suppurative 1 (2%) Necrosis 1 (2%) Nephropathy 35 (70%) 42 (84%) 41 (82%) 44 (90%) 45 (90%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) Renal Tubule, Pigmentation, Lipofuscin 1 (2%) 1 (2%) 4 (8%) 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 50 50 50 60 Early Deaths Natural Death 15 15 17 29 26 Moribund Sacrifice 15 18 15 20 23 Dosing Accident 1 3 1 1 Survivors Terminal Sacrifice 20 16 15 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) (48) Perforation 1 (2%) 1 (2%) Periesophageal Tissue, Inflammation 1 (2%) 1 (2%) Intestine Large, Colon (50) (50) (50) (50) (50) Fibrosis 1 (2%) Mineralization 4 (8%) Necrosis 1 (2%) Parasite Metazoan 1 (2%) 2 (4%) 5 (10%) 1 (2%) 1 (2%) Intestine Large, Rectum (49) (49) (49) (50) (50) Parasite Metazoan 1 (2%) 3 (6%) 5 (10%) 4 (8%) 1 (2%) Intestine Large, Cecum (50) (50) (50) (50) (49) Ulcer 1 (2%) Intestine Small, Duodenum (50) (50) (50) (50) (49) Ulcer 3 (6%) 1 (2%) Peyer's Patch, Hyperplasia 1 (2%) Intestine Small, Jejunum (50) (50) (50) (50) (50) Inflammation, Chronic, Focal 1 (2%) 1 (2%) Intestine Small, Ileum (50) (49) (50) (50) (49) Mineralization 1 (2%) Ulcer 1 (2%) Liver (50) (50) (50) (50) (50) Basophilic Focus 23 (46%) 21 (42%) 22 (44%) 7 (14%) 6 (12%) Clear Cell Focus 4 (8%) 3 (6%) 7 (14%) 3 (6%) 3 (6%) Degeneration, Cystic, Focal 4 (8%) 2 (4%) 25 (50%) 38 (76%) 41 (82%) Degeneration, Fatty, Focal 1 (2%) Eosinophilic Focus 11 (22%) 28 (56%) 43 (86%) 47 (94%) 39 (78%) Hepatodiaphragmatic Nodule 4 (8%) 1 (2%) Inflammation, Acute 1 (2%) 1 (2%) Mixed Cell Focus 1 (2%) 7 (14%) 14 (28%) 8 (16%) 2 (4%) Necrosis, Focal 2 (4%) 2 (4%) 5 (10%) 3 (6%) 2 (4%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 36 (72%) 17 (34%) 16 (32%) 17 (34%) 28 (56%) Bile Duct, Hyperplasia, Atypical, Focal 1 (2%) 2 (4%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Centrilobular, Degeneration 6 (12%) 1 (2%) Centrilobular, Degeneration, Fatty 2 (4%) 1 (2%) Centrilobular, Necrosis 1 (2%) 4 (8%) 1 (2%) 1 (2%) Hepatocyte, Hypertrophy 13 (26%) 25 (50%) 30 (60%) 26 (52%) Oval Cell, Hyperplasia 14 (28%) 17 (34%) 24 (48%) 34 (68%) 27 (54%) Mesentery (5) (6) (1) (1) Fat, Necrosis 5 (100%) 6 (100%) Pancreas (50) (50) (50) (50) (49) Atrophy, Acute 1 (2%) Hyperplasia, Focal 3 (6%) 2 (4%) 1 (2%) 2 (4%) 2 (4%) Acinus, Atrophy 20 (40%) 15 (30%) 13 (26%) 9 (18%) 10 (20%) Acinus, Hyperplasia, Focal 1 (2%) 1 (2%) Artery, Inflammation, Chronic 4 (8%) Salivary Glands (50) (50) (50) (48) (48) Inflammation, Chronic 1 (2%) Parotid Gland, Atrophy 1 (2%) Submandibular Gland, Cytoplasmic Alteration 4 (8%) 50 (100%) 49 (98%) 48 (100%) 48 (100%) Submandibular Gland, Fibrosis 1 (2%) Stomach, Forestomach (50) (50) (50) (50) (49) Hyperkeratosis 1 (2%) Hyperkeratosis, Focal 1 (2%) Inflammation, Chronic 1 (2%) Mineralization 3 (6%) 1 (2%) 6 (12%) 5 (10%) Ulcer 7 (14%) 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) (49) Atrophy 14 (28%) 32 (64%) 37 (74%) 29 (59%) Inflammation, Focal, Suppurative 2 (4%) 3 (6%) 1 (2%) Mineralization 10 (20%) 4 (8%) 15 (30%) 14 (28%) 20 (41%) Ulcer 4 (8%) 2 (4%) 3 (6%) 2 (4%) 8 (16%) Neuroendocrine Cell, Hyperplasia 1 (2%) 8 (16%) 8 (16%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) (50) Mineralization 1 (2%) 2 (4%) 3 (6%) 7 (14%) 9 (18%) Aorta, Hyperplasia 1 (2%) Aorta, Mineralization 5 (10%) 9 (18%) 6 (12%) 10 (20%) Heart (50) (50) (50) (50) (49) Inflammation, Focal, Suppurative 1 (2%) 1 (2%) Atrium, Thrombosis 6 (12%) 5 (10%) 4 (8%) 2 (4%) Endocardium, Fibrosis 1 (2%) Myocardium, Degeneration 45 (90%) 41 (82%) 34 (68%) 37 (74%) 25 (51%) Myocardium, Mineralization 5 (10%) 2 (4%) 11 (22%) 9 (18%) 15 (31%) Valve, Inflammation, Chronic 1 (2%) Valve, Thrombosis 1 (2%) Ventricle, Thrombosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) (50) Hyperplasia, Focal 13 (26%) 12 (24%) 6 (12%) 4 (8%) 5 (10%) Necrosis 1 (2%) 1 (2%) Necrosis, Focal 1 (2%) 1 (2%) Vacuolization Cytoplasmic, Focal 1 (2%) Adrenal Medulla (50) (50) (50) (50) (50) Hematocyst 1 (2%) Hyperplasia 1 (2%) Hyperplasia, Focal 16 (32%) 20 (40%) 21 (42%) 21 (42%) 14 (28%) Islets, Pancreatic (50) (50) (50) (50) (49) Hyperplasia 4 (8%) 1 (2%) Parathyroid Gland (48) (49) (48) (45) (46) Hyperplasia 7 (15%) 2 (4%) 6 (13%) 3 (7%) 7 (15%) Hyperplasia, Focal 2 (4%) 1 (2%) Bilateral, Hyperplasia 10 (21%) 6 (12%) 16 (33%) 18 (40%) 18 (39%) Pituitary Gland (50) (50) (50) (50) (50) Angiectasis 2 (4%) 2 (4%) Cyst 1 (2%) Hyperplasia, Focal 1 (2%) Pars Distalis, Hyperplasia, Focal 12 (24%) 9 (18%) 8 (16%) 2 (4%) 1 (2%) Pars Intermedia, Hyperplasia, Focal 1 (2%) Pars Nervosa, Inflammation, Focal, Suppurative 1 (2%) Rathke's Cleft, Cyst 1 (2%) Thyroid Gland (50) (50) (50) (48) (48) C-Cell, Hyperplasia 22 (44%) 25 (50%) 25 (50%) 10 (21%) 17 (35%) Follicle, Cyst 1 (2%) 1 (2%) 1 (2%) Follicular Cell, Hyperplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (49) (49) (50) (50) Fibrosis 1 (2%) Granuloma Sperm 1 (2%) 1 (2%) Serosa, Hyperplasia, Mesothelium 2 (4%) Preputial Gland (50) (50) (49) (50) (50) Cyst 5 (10%) 2 (4%) 6 (12%) 4 (8%) Fibrosis 1 (2%) Hyperplasia, Focal 3 (6%) 4 (8%) 6 (12%) 4 (8%) 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Inflammation, Chronic 9 (18%) 14 (28%) 8 (16%) 12 (24%) 4 (8%) Inflammation, Chronic Active 1 (2%) Prostate (50) (50) (49) (49) (49) Hyperplasia 1 (2%) 1 (2%) Hyperplasia, Focal 1 (2%) 1 (2%) Inflammation, Chronic 16 (32%) 18 (36%) 13 (27%) 15 (31%) 9 (18%) Seminal Vesicle (50) (50) (50) (50) (50) Inflammation, Suppurative 1 (2%) 2 (4%) 6 (12%) 3 (6%) Mineralization 1 (2%) 3 (6%) Epithelium, Atrophy 1 (2%) Serosa, Hyperplasia, Mesothelium 1 (2%) Testes (50) (49) (49) (50) (50) Atrophy 1 (2%) Germinal Epithelium, Atrophy 3 (6%) 1 (2%) 3 (6%) 1 (2%) Interstitial Cell, Hyperplasia 3 (6%) 1 (2%) Tunic, Hyperplasia, Mesothelium 3 (6%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) (50) Fibrosis 3 (6%) 2 (4%) Hyperplasia 18 (36%) 14 (28%) 22 (44%) 23 (46%) 18 (36%) Necrosis 2 (4%) 2 (4%) 1 (2%) 1 (2%) Lymph Node (8) (4) (4) (4) (3) Lumbar, Hyperplasia, Lymphoid 1 (25%) Mediastinal, Erythrophagocytosis 1 (25%) 1 (33%) Mediastinal, Hyperplasia, Lymphoid 2 (25%) Mediastinal, Inflammation, Suppurative 1 (25%) Lymph Node, Mesenteric (50) (50) (49) (50) (48) Ectasia 1 (2%) Erythrophagocytosis 1 (2%) Inflammation, Suppurative 1 (2%) Spleen (50) (50) (50) (50) (49) Congestion 1 (2%) 1 (2%) 1 (2%) Fibrosis 8 (16%) 11 (22%) 12 (24%) 12 (24%) 4 (8%) Hematopoietic Cell Proliferation 2 (4%) 9 (18%) 2 (4%) 13 (26%) 4 (8%) Hemorrhage 1 (2%) Metaplasia, Lipocyte 1 (2%) Lymphoid Follicle, Atrophy 1 (2%) Lymphoid Follicle, Depletion Cellular 1 (2%) Thymus (46) (45) (43) (42) (43) Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (49) (49) (45) (46) Dilatation 13 (26%) 13 (27%) 4 (8%) 7 (16%) 1 (2%) Galactocele 1 (2%) 1 (2%) Hyperplasia, Focal 1 (2%) 1 (2%) Duct, Granuloma 1 (2%) Skin (50) (50) (50) (50) (50) Cyst Epithelial Inclusion 1 (2%) Edema 1 (2%) Ulcer 2 (4%) 1 (2%) Dermis, Inflammation, Focal, Suppurative 1 (2%) Pinna, Ulcer 1 (2%) Subcutaneous Tissue, Fibrosis 1 (2%) Subcutaneous Tissue, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) Fibrous Osteodystrophy 8 (16%) 2 (4%) 12 (24%) 14 (28%) 21 (42%) Osteopetrosis 1 (2%) 2 (4%) Cranium, Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) Degeneration, Focal 1 (2%) Hydrocephalus 2 (4%) 3 (6%) 3 (6%) 1 (2%) 1 (2%) Necrosis 1 (2%) Necrosis, Focal 2 (4%) 1 (2%) 1 (2%) Hypothalamus, Degeneration 1 (2%) 1 (2%) Spinal Cord (1) (1) (1) Axon, Degeneration, Focal 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (49) Congestion 1 (2%) Erythrophagocytosis 1 (2%) Hemorrhage, Focal 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) Inflammation, Granulomatous 2 (4%) 2 (4%) 3 (6%) 2 (4%) Inflammation, Suppurative 1 (2%) 3 (6%) 2 (4%) 1 (2%) Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%) 2 (4%) 1 (2%) Alveolar Epithelium, Interstitium, a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 08:56:31 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Mineralization 1 (2%) 1 (2%) Bronchiole, Inflammation, Suppurative 1 (2%) Bronchus, Inflammation, Suppurative 1 (2%) Interstitium, Inflammation, Chronic 2 (4%) 1 (2%) 2 (4%) 1 (2%) 1 (2%) Interstitium, Mineralization 4 (8%) 1 (2%) 8 (16%) 10 (20%) 18 (37%) Perivascular, Edema 1 (2%) 1 (2%) Vein, Thrombosis 1 (2%) Nose (50) (50) (50) (50) (50) Inflammation, Suppurative 11 (22%) 14 (28%) 20 (40%) 11 (22%) 9 (18%) Trachea (50) (50) (50) (49) (48) Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (2) (1) Cataract 1 (100%) 1 (50%) 1 (100%) Degeneration 1 (50%) Cornea, Inflammation, Chronic 1 (100%) Retina, Atrophy 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) (50) Hydronephrosis 2 (4%) 1 (2%) Inflammation, Focal, Suppurative 1 (2%) 1 (2%) 2 (4%) 1 (2%) Nephropathy 49 (98%) 46 (92%) 48 (96%) 50 (100%) 47 (94%) Renal Tubule, Cyst 2 (4%) 2 (4%) Renal Tubule, Hyperplasia, Focal 5 (10%) 1 (2%) 7 (14%) 4 (8%) 3 (6%) Renal Tubule, Hyperplasia, Oncocytic 2 (4%) 1 (2%) Urinary Bladder (49) (50) (49) (49) (50) Inflammation, Suppurative 1 (2%) Ulcer 1 (2%) 1 (2%) 2 (4%) Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------