TDMS Study 05187-06 Pathology Tables
NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 CORE STUDY Facility: Battelle Columbus Laboratory Chemical CAS #: 93-15-2 Lock Date: 06/12/96 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: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 5 7 8 13 Natural Death 14 24 23 35 Dosing Accident 1 1 Survivors Natural Death 2 Terminal Sacrifice 31 18 16 2 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (38) (28) (30) (24) Infiltration Cellular, Lymphocyte 1 (4%) Intestine Small, Duodenum (46) (49) (46) (43) Inflammation, Chronic Active 1 (2%) Parasite Metazoan 1 (2%) Ulcer 1 (2%) Epithelium, Necrosis 1 (2%) Intestine Small, Jejunum (46) (46) (40) (40) Inflammation, Suppurative 1 (2%) Ulcer 1 (2%) Liver (50) (50) (49) (50) Atrophy 1 (2%) Basophilic Focus 5 (10%) 2 (4%) 3 (6%) Clear Cell Focus 1 (2%) 2 (4%) 1 (2%) Cyst 1 (2%) Eosinophilic Focus 5 (10%) 9 (18%) 4 (8%) 9 (18%) Fibrosis 1 (2%) 2 (4%) 3 (6%) Hematopoietic Cell Proliferation 4 (8%) 14 (28%) 23 (47%) 24 (48%) Infiltration Cellular, Lymphocyte 23 (46%) 18 (36%) 21 (43%) 19 (38%) Inflammation, Chronic Active 24 (48%) 25 (50%) 16 (33%) 10 (20%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) 2 (4%) Mixed Cell Focus 7 (14%) 3 (6%) Pigmentation, Hemosiderin 11 (22%) 24 (49%) 19 (38%) Tension Lipidosis 2 (4%) Bile Duct, Cyst 1 (2%) 6 (12%) 3 (6%) Bile Duct, Cyst, Multiple 1 (2%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) 11 (22%) 9 (18%) Hepatocyte, Atypia Cellular 1 (2%) Hepatocyte, Hyperplasia, Adenomatous 1 (2%) Hepatocyte, Necrosis 5 (10%) 9 (18%) 16 (33%) 17 (34%) Hepatocyte, Vacuolization Cytoplasmic 20 (40%) 14 (28%) 11 (22%) 12 (24%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Centrilobular, Atrophy 1 (2%) Oval Cell, Hyperplasia 46 (92%) 36 (73%) 38 (76%) Portal, Hypertrophy 10 (20%) 7 (14%) 23 (46%) Mesentery (13) (7) (3) (3) Inflammation, Chronic Active 1 (8%) Inflammation, Suppurative 1 (33%) Artery, Inflammation, Chronic Active 1 (14%) Artery, Necrosis, Fibrinoid 1 (14%) Fat, Necrosis 6 (46%) 3 (43%) 1 (33%) 1 (33%) Pancreas (49) (50) (46) (46) Infiltration Cellular, Lymphocyte 10 (20%) 15 (30%) 13 (28%) 2 (4%) Acinus, Atrophy 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Artery, Necrosis, Fibrinoid 1 (2%) Salivary Glands (50) (45) (44) (42) Infiltration Cellular, Lymphocyte 33 (66%) 29 (64%) 27 (61%) 18 (43%) Stomach, Forestomach (50) (50) (48) (46) Diverticulum 1 (2%) Hyperkeratosis 1 (2%) 3 (6%) 3 (7%) Inflammation, Chronic Active 2 (4%) 1 (2%) Epithelium, Hyperplasia, Squamous 1 (2%) 3 (6%) 2 (4%) 1 (2%) Epithelium, Ulcer 2 (4%) Stomach, Glandular (45) (49) (46) (45) Atrophy 10 (22%) 10 (22%) Ectasia 14 (31%) 33 (67%) 31 (67%) 38 (84%) Hyperplasia 1 (2%) 5 (11%) 2 (4%) Hyperplasia, Atypical 1 (2%) Inflammation, Chronic Active 17 (38%) 21 (43%) 12 (26%) 14 (31%) Mineralization 2 (4%) 1 (2%) 2 (4%) 3 (7%) Necrosis 1 (2%) 3 (7%) 2 (4%) Neuroendocrine Cell, Hyperplasia 1 (2%) Tooth (2) (1) Inflammation, Chronic Active 1 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (49) (47) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Heart (50) (50) (48) (44) Inflammation, Chronic Active 1 (2%) Mineralization 2 (4%) 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Atrium, Thrombosis 1 (2%) 3 (6%) 6 (13%) 9 (20%) Valve, Inflammation, Suppurative 1 (2%) Valve, Thrombosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (49) Degeneration, Fatty 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 8 (16%) 17 (34%) 14 (29%) Pigmentation, Hemosiderin 1 (2%) Subcapsular, Hyperplasia 47 (94%) 48 (96%) 49 (98%) 48 (98%) Adrenal Medulla (50) (50) (50) (49) Hyperplasia 1 (2%) 7 (14%) 5 (10%) Islets, Pancreatic (49) (50) (46) (47) Hyperplasia 8 (16%) 3 (6%) 1 (2%) 2 (4%) Parathyroid Gland (36) (40) (38) (36) Cyst 1 (3%) 1 (3%) Pituitary Gland (48) (44) (44) (40) Pars Distalis, Angiectasis 7 (15%) Pars Distalis, Cyst 1 (2%) 1 (2%) 1 (3%) Pars Distalis, Hyperplasia 6 (13%) 8 (18%) 3 (7%) 3 (8%) Thyroid Gland (50) (46) (46) (42) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic Active 1 (2%) Follicle, Cyst 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 8 (16%) 10 (22%) 7 (15%) 5 (12%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (47) (46) (44) Cyst 2 (4%) Infiltration Cellular, Lymphocyte 1 (2%) Ovary (50) (49) (48) (41) Angiectasis 1 (2%) 1 (2%) Cyst 12 (24%) 7 (14%) 7 (15%) 4 (10%) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) Mineralization 1 (2%) Pigmentation, Hemosiderin 1 (2%) Thrombosis 2 (5%) Uterus (50) (50) (49) (47) Hemorrhage 1 (2%) Hydrometra 25 (50%) 24 (48%) 15 (31%) 5 (11%) Hyperplasia, Cystic 19 (38%) 10 (20%) 2 (4%) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (48) (50) Hyperplasia 18 (36%) 47 (94%) 46 (96%) 50 (100%) Myelofibrosis 10 (20%) 7 (14%) 3 (6%) 3 (6%) Lymph Node (13) (7) (8) (4) Inguinal, Infiltration Cellular, Mast Cell 1 (25%) Lumbar, Ectasia 1 (14%) Mediastinal, Hyperplasia, Lymphoid 2 (15%) Mediastinal, Necrosis 1 (14%) Pancreatic, Hyperplasia 1 (14%) Renal, Ectasia 1 (8%) Lymph Node, Mandibular (49) (43) (41) (32) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Lymph Node, Mesenteric (47) (48) (43) (36) Angiectasis 1 (2%) 1 (2%) Ectasia 1 (2%) 2 (4%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Necrosis 1 (2%) 1 (2%) Spleen (50) (50) (46) (46) Atrophy 1 (2%) Fibrosis 1 (2%) Necrosis 1 (2%) Pigmentation, Hemosiderin 1 (2%) Lymphoid Follicle, Depletion Cellular 1 (2%) 2 (4%) Lymphoid Follicle, Hyperplasia, Lymphoid 8 (16%) 3 (6%) 2 (4%) Lymphoid Follicle, Necrosis 2 (4%) 4 (9%) 1 (2%) Red Pulp, Hematopoietic Cell Proliferation 29 (58%) 40 (80%) 45 (98%) 44 (96%) Thymus (45) (43) (40) (33) Cyst 14 (31%) 9 (21%) 5 (13%) 7 (21%) Ectopic Parathyroid Gland 1 (3%) Thymocyte, Necrosis 2 (5%) 3 (8%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (48) (50) (37) Hyperplasia, Cystic 1 (2%) 1 (2%) Skin (50) (50) (50) (49) Subcutaneous Tissue, Infiltration Cellular, Lymphocyte 1 (2%) 2 (4%) 2 (4%) Subcutaneous Tissue, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (2) (8) (3) (3) Infiltration Cellular, Lymphocyte 5 (63%) 1 (33%) 2 (67%) Artery, Inflammation, Chronic Active 1 (13%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Peripheral Nerve (1) Demyelination 1 (100%) Spinal Cord (1) Demyelination 1 (100%) Artery, Inflammation, Chronic Active 1 (100%) Artery, Necrosis, Fibrinoid 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (48) (45) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (4%) Inflammation, Suppurative 1 (2%) Metaplasia, Osseous 1 (2%) Alveolar Epithelium, Hyperplasia 2 (4%) 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 2 (4%) 4 (9%) Bronchiole, Exudate, Organized 1 (2%) Mediastinum, Inflammation, Chronic Active 1 (2%) Mediastinum, Necrosis 1 (2%) Nose (50) (50) (49) (47) Inflammation, Suppurative 8 (16%) 11 (22%) 13 (27%) 11 (23%) Nasolacrimal Duct, Inflammation, Suppurative 4 (8%) 15 (30%) 11 (22%) 12 (26%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) Atrophy 1 (100%) Hemorrhage 1 (50%) Inflammation, Suppurative 1 (50%) Cornea, Inflammation, Chronic Active 1 (50%) Harderian Gland (5) (2) (2) Inflammation, Suppurative 1 (50%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) Accumulation, Hyaline Droplet 1 (2%) 3 (6%) Hydronephrosis 2 (4%) Infiltration Cellular, Lymphocyte 28 (56%) 29 (58%) 29 (58%) 23 (47%) Metaplasia, Osseous 2 (4%) 1 (2%) 1 (2%) Mineralization 1 (2%) 3 (6%) 2 (4%) 2 (4%) Necrosis 1 (2%) Nephropathy 10 (20%) 13 (26%) 9 (18%) 10 (20%) Artery, Inflammation, Chronic Active 2 (4%) Cortex, Cyst 1 (2%) 2 (4%) Glomerulus, Amyloid Deposition 1 (2%) Renal Tubule, Hyperplasia 1 (2%) Renal Tubule, Pigmentation, Hemosiderin 2 (4%) 2 (4%) Urinary Bladder (50) (49) (47) (46) Infiltration Cellular, Lymphocyte 20 (40%) 29 (59%) 27 (57%) 25 (54%) Inflammation, Chronic Active 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 5 6 5 9 Natural Death 6 8 7 4 Accidently Killed 1 1 Dosing Accident 1 Survivors Terminal Sacrifice 38 36 37 35 Missing 1 Animals Examined Microscopically 49 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Duodenum (47) (47) (48) (50) Inflammation, Chronic Active 1 (2%) Ulcer 1 (2%) Intestine Small, Jejunum (49) (49) (48) (48) Inflammation, Chronic Active 1 (2%) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%) Peyer's Patch, Inflammation, Suppurative 1 (2%) Liver (49) (50) (50) (50) Angiectasis 1 (2%) Atrophy 1 (2%) Basophilic Focus 5 (10%) 3 (6%) 1 (2%) 3 (6%) Clear Cell Focus 16 (33%) 8 (16%) 2 (4%) 6 (12%) Eosinophilic Focus 10 (20%) 20 (40%) 25 (50%) 19 (38%) Fibrosis 1 (2%) 4 (8%) 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 9 (18%) 7 (14%) 9 (18%) Infiltration Cellular, Lymphocyte 6 (12%) 5 (10%) 12 (24%) 10 (20%) Inflammation, Chronic Active 19 (39%) 21 (42%) 28 (56%) 28 (56%) Mineralization 3 (6%) 1 (2%) Mixed Cell Focus 9 (18%) 13 (26%) 9 (18%) 7 (14%) Pigmentation, Hemosiderin 3 (6%) 5 (10%) 6 (12%) 5 (10%) Tension Lipidosis 1 (2%) Bile Duct, Cyst 1 (2%) 1 (2%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) Hepatocyte, Necrosis 8 (16%) 14 (28%) 8 (16%) 10 (20%) Hepatocyte, Vacuolization Cytoplasmic 7 (14%) 7 (14%) 2 (4%) 13 (26%) Hepatocyte, Centrilobular, Atrophy 1 (2%) Hepatocyte, Centrilobular, Necrosis 2 (4%) Oval Cell, Hyperplasia 8 (16%) 27 (54%) 46 (92%) Portal, Hypertrophy 1 (2%) 7 (14%) 46 (92%) Mesentery (1) (2) (1) (1) Thrombosis 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Fat, Necrosis 1 (100%) Pancreas (49) (49) (50) (50) Cyst 1 (2%) 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) 4 (8%) 4 (8%) Inflammation, Chronic Active 1 (2%) Acinus, Atrophy 3 (6%) Artery, Inflammation, Chronic Active 1 (2%) Salivary Glands (49) (50) (50) (50) Atrophy 1 (2%) Infiltration Cellular, Lymphocyte 31 (63%) 29 (58%) 28 (56%) 34 (68%) Stomach, Forestomach (49) (50) (50) (50) Hyperkeratosis 1 (2%) 4 (8%) Hyperplasia, Squamous 1 (2%) Inflammation, Chronic Active 2 (4%) 3 (6%) Epithelium, Hyperplasia, Squamous 5 (10%) 2 (4%) 3 (6%) 2 (4%) Epithelium, Ulcer 1 (2%) Stomach, Glandular (49) (48) (49) (50) Atrophy 3 (6%) 35 (71%) 45 (90%) Ectasia 13 (27%) 25 (52%) 40 (82%) 49 (98%) Hyperplasia 1 (2%) 15 (31%) 20 (40%) Hyperplasia, Atypical 1 (2%) 2 (4%) Inflammation, Chronic Active 10 (20%) 11 (23%) 25 (51%) 33 (66%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) 1 (2%) 4 (8%) Necrosis 1 (2%) Neuroendocrine Cell, Hyperplasia 4 (8%) Tooth (23) (13) (4) (5) Inflammation, Chronic Active 1 (4%) 1 (8%) 1 (20%) Malformation 22 (96%) 12 (92%) 4 (100%) 4 (80%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (49) (50) (50) (50) Cardiomyopathy 1 (2%) 2 (4%) Mineralization 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) Atrium, Thrombosis 1 (2%) 1 (2%) 2 (4%) Valve, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (50) (50) (50) Accessory Adrenal Cortical Nodule 2 (4%) Angiectasis 1 (2%) 1 (2%) 1 (2%) Degeneration, Fatty 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hypertrophy 5 (10%) 3 (6%) 2 (4%) Pigmentation, Hemosiderin 1 (2%) Subcapsular, Hyperplasia 38 (78%) 42 (84%) 44 (88%) 43 (86%) Islets, Pancreatic (49) (49) (50) (50) Hyperplasia 32 (65%) 26 (53%) 18 (36%) 17 (34%) Pituitary Gland (45) (48) (44) (45) Pars Distalis, Cyst 5 (11%) 7 (15%) 3 (7%) 1 (2%) Thyroid Gland (49) (50) (50) (50) Inflammation, Chronic Active 1 (2%) 3 (6%) Follicle, Cyst 2 (4%) 2 (4%) 2 (4%) 2 (4%) Follicular Cell, Hyperplasia 2 (4%) 7 (14%) 6 (12%) 5 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (50) (50) (50) Cyst 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) 2 (4%) Mineralization 1 (2%) Preputial Gland (49) (50) (50) (50) Cyst 7 (14%) 6 (12%) 10 (20%) 5 (10%) Infiltration Cellular, Lymphocyte 17 (35%) 15 (30%) 14 (28%) 18 (36%) Inflammation, Chronic Active 3 (6%) 4 (8%) 8 (16%) 2 (4%) Prostate (49) (50) (50) (50) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic Active 2 (4%) 2 (4%) Artery, Inflammation, Chronic Active 1 (2%) Seminal Vesicle (49) (50) (50) (50) Inflammation, Suppurative 1 (2%) Testes (49) (50) (50) (50) Germinal Epithelium, Atrophy 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (49) (50) (50) Atrophy 1 (2%) Hyperplasia 14 (29%) 26 (53%) 33 (66%) 35 (70%) Infiltration Cellular, Mast Cell 1 (2%) Necrosis 1 (2%) Lymph Node (3) (4) (5) (3) Lumbar, Hyperplasia, Plasma Cell 1 (33%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Mediastinal, Necrosis 1 (33%) Renal, Hyperplasia, Plasma Cell 1 (33%) Lymph Node, Mandibular (48) (46) (47) (45) Hyperplasia, Lymphoid 2 (4%) Hyperplasia, Plasma Cell 1 (2%) Necrosis 1 (2%) Lymph Node, Mesenteric (49) (46) (49) (50) Angiectasis 1 (2%) Atrophy 1 (2%) Congestion 1 (2%) Ectasia 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) Hyperplasia 1 (2%) Hyperplasia, Lymphoid 2 (4%) 1 (2%) Inflammation, Chronic Active 1 (2%) Necrosis 2 (4%) 2 (4%) 1 (2%) Spleen (49) (49) (50) (50) Atrophy 2 (4%) Fibrosis 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) Pigmentation, Hemosiderin 1 (2%) Lymphoid Follicle, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 3 (6%) Lymphoid Follicle, Necrosis 3 (6%) 6 (12%) 1 (2%) 2 (4%) Red Pulp, Erythrophagocytosis 1 (2%) Red Pulp, Hematopoietic Cell Proliferation 10 (20%) 20 (41%) 25 (50%) 19 (38%) Thymus (37) (40) (38) (45) Cyst 10 (27%) 19 (48%) 16 (42%) 12 (27%) Ectopic Parathyroid Gland 1 (3%) 1 (2%) Thymocyte, Necrosis 1 (3%) 1 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (50) (50) (50) Subcutaneous Tissue, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (2) (1) (3) (3) Infiltration Cellular, Lymphocyte 1 (50%) 2 (67%) 1 (33%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (50) (50) (50) Necrosis 1 (2%) Spinal Cord (2) (2) Hemorrhage 1 (50%) Nerve, Demyelination 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (50) (50) (50) Infiltration Cellular, Lymphocyte 1 (2%) Inflammation, Chronic Active 2 (4%) 2 (4%) Inflammation, Suppurative 1 (2%) 1 (2%) Thrombosis 2 (4%) 1 (2%) Alveolar Epithelium, Hyperplasia 7 (14%) 6 (12%) 5 (10%) 5 (10%) Alveolus, Infiltration Cellular, Lymphocyte 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 2 (4%) 1 (2%) 2 (4%) Bronchiole, Hyperplasia 1 (2%) Mediastinum, Inflammation, Chronic Active 1 (2%) Mediastinum, Necrosis 1 (2%) Nose (49) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 9 (18%) 13 (26%) 11 (22%) 10 (20%) Polyp, Inflammatory 1 (2%) 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 4 (8%) 2 (4%) 8 (16%) 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Cornea, Inflammation, Chronic Active 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) (50) Infiltration Cellular, Lymphocyte 29 (59%) 32 (64%) 27 (54%) 40 (80%) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) Metaplasia, Osseous 1 (2%) 3 (6%) 1 (2%) Mineralization 1 (2%) 3 (6%) 4 (8%) Necrosis 1 (2%) Nephropathy 43 (88%) 45 (90%) 45 (90%) 48 (96%) Artery, Inflammation, Chronic Active 1 (2%) Cortex, Cyst 10 (20%) 27 (54%) 20 (40%) 14 (28%) Papilla, Mineralization 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion NTP Experiment-Test: 05187-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98 Route: GAVAGE Time: 10:15:51 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Papilla, Necrosis 1 (2%) Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) Renal Tubule, Pigmentation, Hemosiderin 1 (2%) Urinary Bladder (49) (50) (50) (50) Calculus Gross Observation 1 (2%) Infiltration Cellular, Lymphocyte 6 (12%) 5 (10%) 9 (18%) 14 (28%) Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------