TDMS Study 92012-06 Pathology Tables
NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 FINAL #1; REVISION #2 MICE Facility: Southern Research Institute Chemical CAS #: 693-98-1 Lock Date: 10/16/01 Cage Range: All Reasons For Removal: 25019 Moribund Sacrifice 25020 Natural Death 25026 Other 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: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Early Deaths Moribund Sacrifice 2 3 4 4 Natural Death 2 3 2 1 Survivors Terminal Sacrifice 46 42 42 45 Moribund Sacrifice 1 Natural Death 1 Other 1 1 Animals Examined Microscopically 50 49 49 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (48) (48) (50) Edema 2 (4%) 2 (4%) 2 (4%) Intestine Small, Jejunum (50) (46) (48) (49) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Peyer's Patch, Infiltration Cellular, Polymorphonuclear 1 (2%) Intestine Small, Ileum (47) (49) (47) (48) Hyperplasia, Lymphoid 1 (2%) Peyer's Patch, Infiltration Cellular, Polymorphonuclear 1 (2%) Liver (50) (49) (49) (50) Angiectasis 1 (2%) Basophilic Focus 4 (8%) 1 (2%) 1 (2%) Clear Cell Focus 1 (2%) 1 (2%) 4 (8%) Eosinophilic Focus 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 3 (6%) 5 (10%) 3 (6%) Hemorrhage 1 (2%) Hepatodiaphragmatic Nodule 1 (2%) 2 (4%) Hyperplasia, Lymphoid 3 (6%) 3 (6%) 6 (12%) Infarct 1 (2%) Infiltration Cellular, Mixed Cell 13 (26%) 5 (10%) 12 (24%) 10 (20%) Mixed Cell Focus 4 (8%) 1 (2%) 3 (6%) Necrosis, Focal 5 (10%) 2 (4%) 3 (6%) 4 (8%) Tension Lipidosis 2 (4%) Bile Duct, Hyperplasia 1 (2%) Hepatocyte, Vacuolization Cytoplasmic 1 (2%) Kupffer Cell, Pigmentation 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mesentery (3) (4) (6) (6) Inflammation, Chronic 1 (33%) 1 (25%) Fat, Angiectasis 1 (17%) 1 (17%) Fat, Necrosis 2 (67%) 3 (75%) 6 (100%) 6 (100%) Pancreas (50) (49) (48) (50) Atrophy 1 (2%) Cyst 1 (2%) 1 (2%) 1 (2%) 2 (4%) Acinus, Cytoplasmic Alteration 2 (4%) 1 (2%) Salivary Glands (50) (49) (49) (49) Atrophy 2 (4%) 1 (2%) Hyperplasia, Lymphoid 5 (10%) 3 (6%) 2 (4%) Stomach, Forestomach (50) (49) (49) (50) Diverticulum 1 (2%) 5 (10%) Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (4%) Epithelium, Hyperplasia 1 (2%) 4 (8%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) (49) (50) Cardiomyopathy 2 (4%) Thrombosis 1 (2%) Myocardium, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (49) (50) Accessory Adrenal Cortical Nodule 7 (14%) 5 (10%) 4 (8%) 6 (12%) Hyperplasia, Focal 2 (4%) Capsule, Hyperplasia 3 (6%) Adrenal Medulla (50) (49) (49) (50) Hyperplasia 1 (2%) Islets, Pancreatic (50) (48) (48) (50) Hyperplasia 1 (2%) 1 (2%) 1 (2%) Parathyroid Gland (48) (46) (45) (48) Cyst 1 (2%) 1 (2%) 1 (2%) Pituitary Gland (50) (49) (47) (49) Pars Distalis, Angiectasis 3 (6%) 1 (2%) 1 (2%) Pars Distalis, Cyst 1 (2%) 3 (6%) 1 (2%) Pars Distalis, Hyperplasia, Focal 1 (2%) 2 (4%) 1 (2%) 2 (4%) Thyroid Gland (49) (48) (48) (50) Degeneration, Cystic 15 (31%) 14 (29%) 12 (25%) 9 (18%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Follicle, Cyst 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 9 (18%) Follicular Cell, Hypertrophy 6 (12%) 3 (6%) 23 (48%) 46 (92%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (48) (48) (50) Inflammation, Chronic 1 (2%) Ovary (50) (49) (49) (48) Angiectasis 12 (24%) 7 (14%) 8 (16%) 8 (17%) Cyst 10 (20%) 11 (22%) 15 (31%) 10 (21%) Inflammation, Chronic 3 (6%) 2 (4%) Thrombosis 1 (2%) Corpus Luteum, Hyperplasia 1 (2%) Uterus (50) (49) (49) (50) Angiectasis 3 (6%) 2 (4%) 2 (4%) 6 (12%) Inflammation, Chronic 6 (12%) 2 (4%) 9 (18%) 4 (8%) Metaplasia, Squamous 5 (10%) 5 (10%) 1 (2%) Cervix, Cyst Epithelial Inclusion 1 (2%) Endometrium, Fibrosis 1 (2%) Endometrium, Hyperplasia, Cystic 48 (96%) 47 (96%) 46 (94%) 45 (90%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (48) (50) Hyperplasia 10 (20%) 5 (10%) 13 (27%) 16 (32%) Lymph Node (12) (6) (8) (9) Bronchial, Hyperplasia, Lymphoid 1 (8%) 2 (22%) Iliac, Ectasia 1 (13%) Iliac, Hematopoietic Cell Proliferation 2 (17%) 1 (17%) 1 (13%) Iliac, Hyperplasia, Lymphoid 5 (42%) 3 (50%) 4 (50%) 2 (22%) Iliac, Pigmentation 1 (17%) Inguinal, Hyperplasia, Lymphoid 1 (13%) Lumbar, Hyperplasia, Lymphoid 1 (8%) 1 (17%) 2 (25%) 2 (22%) Lumbar, Pigmentation 1 (17%) Mediastinal, Hyperplasia, Lymphoid 1 (8%) 1 (17%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Pancreatic, Hyperplasia, Lymphoid 1 (13%) Renal, Hematopoietic Cell Proliferation 1 (8%) 1 (13%) Renal, Hyperplasia, Lymphoid 3 (25%) 1 (17%) 2 (25%) Lymph Node, Mandibular (48) (48) (46) (48) Atrophy 2 (4%) Hematopoietic Cell Proliferation 3 (6%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 11 (23%) 12 (25%) 10 (22%) 15 (31%) Hyperplasia, Plasma Cell 2 (4%) 1 (2%) 4 (9%) Pigmentation 24 (50%) 20 (42%) 21 (46%) 21 (44%) Lymph Node, Mesenteric (48) (48) (47) (48) Ectasia 1 (2%) Hematopoietic Cell Proliferation 5 (10%) 3 (6%) 3 (6%) Hemorrhage 1 (2%) 1 (2%) Hyperplasia, Lymphoid 3 (6%) 7 (15%) 4 (9%) 6 (13%) Hyperplasia, Plasma Cell 1 (2%) Spleen (50) (49) (49) (50) Angiectasis 1 (2%) Atrophy 1 (2%) 1 (2%) Congestion 2 (4%) Hematopoietic Cell Proliferation 15 (30%) 20 (41%) 24 (49%) 39 (78%) Hyperplasia, Plasma Cell 1 (2%) Pigmentation 4 (8%) 11 (22%) 34 (68%) Lymphoid Follicle, Atrophy 1 (2%) 3 (6%) 5 (10%) 4 (8%) Lymphoid Follicle, Hyperplasia 12 (24%) 14 (29%) 13 (27%) 16 (32%) Thymus (50) (48) (48) (50) Atrophy 5 (10%) 2 (4%) 7 (15%) 3 (6%) Hyperplasia, Lymphoid 4 (8%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (49) (50) Hyperplasia 2 (4%) 2 (4%) Skin (50) (49) (49) (50) Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (49) (49) (50) Hyperostosis 9 (18%) 13 (27%) 10 (20%) 11 (22%) Skeletal Muscle (1) (1) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Necrosis 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (49) (50) Hemorrhage 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) Vacuolization Cytoplasmic 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) (49) (50) Edema 2 (4%) 1 (2%) Foreign Body 2 (4%) 2 (4%) 2 (4%) Hemorrhage 4 (8%) 3 (6%) 1 (2%) 4 (8%) Hyperplasia, Lymphoid 9 (18%) 6 (12%) 3 (6%) 7 (14%) Infiltration Cellular, Histiocyte 2 (4%) 2 (4%) 3 (6%) Thrombosis 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) 3 (6%) 2 (4%) Nose (50) (49) (49) (50) Foreign Body 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (49) (49) (50) Atrophy 1 (2%) Cataract 1 (2%) 2 (4%) Inflammation, Chronic 1 (2%) 2 (4%) Harderian Gland (50) (49) (49) (50) Hyperplasia 1 (2%) Hyperplasia, Focal 3 (6%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (49) (50) Cyst 1 (2%) 2 (4%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 8 (16%) 16 (33%) 8 (16%) 4 (8%) Infarct 2 (4%) 2 (4%) Inflammation, Chronic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Metaplasia, Osseous 1 (2%) 2 (4%) Nephropathy 27 (54%) 17 (35%) 21 (43%) 19 (38%) Papilla, Necrosis 1 (2%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 1 (2%) Renal Tubule, Dilatation 1 (2%) Renal Tubule, Necrosis 1 (2%) 1 (2%) Renal Tubule, Pigmentation 2 (4%) Urinary Bladder (50) (49) (49) (50) Hyperplasia, Lymphoid 16 (32%) 16 (33%) 6 (12%) 11 (22%) Inflammation, Chronic 1 (2%) 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Early Deaths Moribund Sacrifice 4 1 5 5 Natural Death 3 3 9 5 Survivors Terminal Sacrifice 43 46 36 40 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (49) (49) (47) (50) Edema 2 (4%) 1 (2%) 1 (2%) 1 (2%) Intestine Small, Duodenum (49) (49) (45) (50) Epithelium, Hyperplasia 1 (2%) Intestine Small, Jejunum (50) (49) (46) (50) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Infiltration Cellular, Polymorphonuclear 1 (2%) Intestine Small, Ileum (49) (50) (45) (49) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Infiltration Cellular, Polymorphonuclear 1 (2%) Liver (50) (50) (50) (50) Angiectasis 2 (4%) 1 (2%) Basophilic Focus 2 (4%) 3 (6%) 1 (2%) 3 (6%) Clear Cell Focus 6 (12%) 9 (18%) 6 (12%) 8 (16%) Cyst 1 (2%) Eosinophilic Focus 3 (6%) 3 (6%) 2 (4%) 6 (12%) Hematopoietic Cell Proliferation 1 (2%) 2 (4%) 2 (4%) Hepatodiaphragmatic Nodule 1 (2%) Infarct 1 (2%) Infiltration Cellular, Mixed Cell 5 (10%) 7 (14%) 7 (14%) 7 (14%) Mixed Cell Focus 4 (8%) 3 (6%) 4 (8%) 4 (8%) Necrosis, Diffuse 1 (2%) Necrosis, Focal 2 (4%) 6 (12%) 2 (4%) 6 (12%) Tension Lipidosis 2 (4%) 1 (2%) Hepatocyte, Cytoplasmic Alteration 11 (22%) 37 (74%) Hepatocyte, Karyomegaly 10 (20%) 29 (58%) Hepatocyte, Vacuolization Cytoplasmic 1 (2%) 1 (2%) Kupffer Cell, Pigmentation 1 (2%) 1 (2%) 19 (38%) Mesentery (6) (2) (5) (2) Angiectasis 1 (50%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic 1 (50%) Fat, Necrosis 4 (67%) 1 (50%) 3 (60%) 2 (100%) Pancreas (50) (50) (49) (50) Atrophy 1 (2%) 1 (2%) Cyst 2 (4%) 3 (6%) 2 (4%) Acinus, Cytoplasmic Alteration 2 (4%) 1 (2%) Salivary Glands (50) (50) (50) (50) Hyperplasia, Lymphoid 2 (4%) 2 (4%) Stomach, Forestomach (50) (49) (50) (50) Diverticulum 2 (4%) Inflammation, Chronic Active 1 (2%) 1 (2%) Ulcer 1 (2%) 1 (2%) Epithelium, Hyperplasia 2 (4%) 2 (4%) 1 (2%) 1 (2%) Stomach, Glandular (50) (49) (49) (50) Glands, Dysplasia 1 (2%) Tooth (1) Inflammation, Chronic 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Cardiomyopathy 1 (2%) 1 (2%) Perivascular, Inflammation, Chronic 3 (6%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 2 (4%) 6 (12%) 8 (16%) 6 (12%) Hyperplasia, Focal 2 (4%) 4 (8%) 3 (6%) 1 (2%) Hypertrophy, Focal 13 (26%) 18 (36%) 10 (20%) 10 (20%) Capsule, Hyperplasia 1 (2%) 2 (4%) 3 (6%) 2 (4%) Adrenal Medulla (50) (50) (50) (50) Hyperplasia 2 (4%) Islets, Pancreatic (50) (50) (49) (50) Hyperplasia 2 (4%) 1 (2%) Parathyroid Gland (49) (47) (45) (48) Cyst 3 (6%) 1 (2%) 2 (4%) 1 (2%) Pituitary Gland (49) (48) (48) (50) Pars Distalis, Cyst 2 (4%) 1 (2%) 2 (4%) 2 (4%) Pars Distalis, Hyperplasia, Focal 1 (2%) Thyroid Gland (50) (50) (50) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Degeneration, Cystic 10 (20%) 2 (4%) 3 (6%) 4 (8%) Follicular Cell, Hyperplasia 2 (4%) 3 (6%) 33 (66%) Follicular Cell, Hypertrophy 1 (2%) 6 (12%) 25 (50%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Fibrosis 1 (2%) Granuloma Sperm 3 (6%) 6 (12%) Hyperplasia, Lymphoid 2 (4%) 1 (2%) Hypospermia 1 (2%) Inflammation, Chronic Active 1 (2%) 3 (6%) 7 (14%) 8 (16%) Penis (1) (1) (1) Angiectasis 1 (100%) 1 (100%) Preputial Gland (50) (50) (50) (50) Cyst 18 (36%) 23 (46%) 16 (32%) 21 (42%) Inflammation, Chronic 14 (28%) 10 (20%) 14 (28%) 7 (14%) Prostate (49) (50) (49) (50) Inflammation, Chronic 2 (4%) Seminal Vesicle (50) (50) (50) (50) Atrophy 1 (2%) Testes (50) (50) (50) (50) Germinal Epithelium, Atrophy 1 (2%) 4 (8%) 8 (16%) 14 (28%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hyperplasia 4 (8%) 10 (20%) 20 (40%) 42 (84%) Lymph Node (2) (3) (1) Bronchial, Hyperplasia, Lymphoid 1 (33%) Lymph Node, Mandibular (48) (46) (45) (50) Atrophy 1 (2%) 2 (4%) 4 (8%) Ectasia 1 (2%) Hyperplasia, Lymphoid 10 (21%) 14 (30%) 9 (20%) 13 (26%) Pigmentation 8 (17%) 6 (13%) 9 (20%) 6 (12%) Lymph Node, Mesenteric (47) (47) (46) (48) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Angiectasis 1 (2%) Atrophy 1 (2%) 1 (2%) 2 (4%) 2 (4%) Hemorrhage 4 (9%) 2 (4%) 2 (4%) Hyperplasia, Lymphoid 7 (15%) 7 (15%) 15 (33%) 10 (21%) Necrosis 1 (2%) 1 (2%) Spleen (50) (50) (49) (50) Angiectasis 1 (2%) Atrophy 1 (2%) 4 (8%) 3 (6%) Hematopoietic Cell Proliferation 10 (20%) 21 (42%) 38 (78%) 45 (90%) Pigmentation 1 (2%) 16 (32%) 33 (67%) 43 (86%) Lymphoid Follicle, Atrophy 4 (8%) 14 (29%) 30 (60%) Lymphoid Follicle, Hyperplasia 5 (10%) 2 (4%) 2 (4%) Thymus (47) (46) (46) (47) Atrophy 7 (15%) 5 (11%) 9 (20%) 8 (17%) Cyst 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) (2) Atrophy 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Compression 1 (2%) Peripheral Nerve (1) (1) Atrophy 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Edema 1 (2%) 3 (6%) 1 (2%) 3 (6%) Hemorrhage 4 (8%) 8 (16%) 4 (8%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2-METHYLIMIDAZOLE Date: 08/06/04 Route: DOSED FEED Time: 09:39:04 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Hyperplasia, Lymphoid 1 (2%) 2 (4%) 2 (4%) 4 (8%) Infiltration Cellular, Histiocyte 4 (8%) 4 (8%) 4 (8%) 2 (4%) Inflammation, Chronic 1 (2%) 2 (4%) Metaplasia, Osseous 2 (4%) Thrombosis 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 5 (10%) 3 (6%) 1 (2%) 3 (6%) Alveolar Epithelium, Hyperplasia, Multifocal 1 (2%) Nose (50) (50) (50) (50) Foreign Body 1 (2%) 3 (6%) 3 (6%) 2 (4%) Inflammation, Chronic 1 (2%) 4 (8%) 3 (6%) 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (50) (50) (50) Cataract 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%) 2 (4%) Cornea, Hyperplasia 1 (2%) 1 (2%) Harderian Gland (50) (50) (48) (50) Hyperplasia, Focal 1 (2%) 2 (4%) Inflammation, Chronic 3 (6%) 4 (8%) 2 (4%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 13 (26%) 11 (22%) 12 (24%) 19 (38%) Hydronephrosis 1 (2%) Hyperplasia, Lymphoid 1 (2%) 3 (6%) 3 (6%) 3 (6%) Infarct 6 (12%) 6 (12%) 6 (12%) 1 (2%) Inflammation, Suppurative 1 (2%) Metaplasia, Osseous 5 (10%) 3 (6%) 2 (4%) 3 (6%) Nephropathy 34 (68%) 43 (86%) 32 (64%) 31 (62%) Papilla, Necrosis 1 (2%) Renal Tubule, Hyperplasia 1 (2%) 1 (2%) 2 (4%) 3 (6%) Renal Tubule, Pigmentation 1 (2%) 2 (4%) 45 (90%) Urethra (1) Angiectasis 1 (100%) Inflammation, Suppurative 1 (100%) Urinary Bladder (50) (50) (50) (50) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------