TDMS Study 92012-06 Pathology Tables
NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 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 b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 1 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ 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 [2.0] 2 [2.0] 2 [2.0] Intestine Small, Jejunum (50) (46) (48) (49) Hyperplasia, Lymphoid 1 [3.0] 1 [3.0] Peyer's Patch, Infiltration Cellular, Polymorphonuclear 1 [3.0] Intestine Small, Ileum (47) (49) (47) (48) Hyperplasia, Lymphoid 1 [3.0] Peyer's Patch, Infiltration Cellular, Polymorphonuclear 1 [3.0] Liver (50) (49) (49) (50) Angiectasis 1 [3.0] Basophilic Focus 4 1 1 Clear Cell Focus 1 1 4 Eosinophilic Focus 1 Hematopoietic Cell Proliferation 3 [3.0] 3 [2.0] 5 [1.8] 3 [3.0] Hemorrhage 1 [3.0] Hepatodiaphragmatic Nodule 1 2 Hyperplasia, Lymphoid 3 [2.0] 3 [2.3] 6 [2.2] Infarct 1 [3.0] Infiltration Cellular, Mixed Cell 13 [1.7] 5 [1.6] 12 [1.3] 10 [1.1] Mixed Cell Focus 4 1 3 Necrosis, Focal 5 [1.6] 2 [1.0] 3 [2.7] 4 [3.3] Tension Lipidosis 2 Bile Duct, Hyperplasia 1 [3.0] Hepatocyte, Vacuolization Cytoplasmic 1 [3.0] Kupffer Cell, Pigmentation 2 [4.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 2 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Mesentery (3) (4) (6) (6) Inflammation, Chronic 1 [4.0] 1 [3.0] Fat, Angiectasis 1 [3.0] 1 [3.0] Fat, Necrosis 2 [3.0] 3 [2.3] 6 [1.8] 6 [2.8] Pancreas (50) (49) (48) (50) Atrophy 1 [4.0] Cyst 1 [3.0] 1 [3.0] 1 [3.0] 2 [3.0] Acinus, Cytoplasmic Alteration 2 [3.0] 1 [3.0] Salivary Glands (50) (49) (49) (49) Atrophy 2 [2.0] 1 [1.0] Hyperplasia, Lymphoid 5 [2.6] 3 [2.0] 2 [2.0] Stomach, Forestomach (50) (49) (49) (50) Diverticulum 1 5 Inflammation, Chronic Active 1 [2.0] 1 [2.0] 2 [2.5] Epithelium, Hyperplasia 1 [2.0] 4 [2.5] 1 [1.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (49) (49) (50) Cardiomyopathy 2 [1.0] Thrombosis 1 [3.0] Myocardium, Necrosis 1 [2.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (49) (49) (50) Accessory Adrenal Cortical Nodule 7 [3.0] 5 [3.0] 4 [3.0] 6 [3.0] Hyperplasia, Focal 2 [1.5] Capsule, Hyperplasia 3 [2.0] Adrenal Medulla (50) (49) (49) (50) Hyperplasia 1 [2.0] Islets, Pancreatic (50) (48) (48) (50) Hyperplasia 1 [2.0] 1 [2.0] 1 [2.0] Parathyroid Gland (48) (46) (45) (48) Cyst 1 [3.0] 1 [3.0] 1 [3.0] Pituitary Gland (50) (49) (47) (49) Pars Distalis, Angiectasis 3 [2.3] 1 [2.0] 1 [2.0] Pars Distalis, Cyst 1 [3.0] 3 [3.0] 1 [2.0] Pars Distalis, Hyperplasia, Focal 1 [3.0] 2 [1.5] 1 [1.0] 2 [2.0] Thyroid Gland (49) (48) (48) (50) Degeneration, Cystic 15 [2.1] 14 [1.8] 12 [1.7] 9 [1.2] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 3 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Follicle, Cyst 1 [3.0] 1 [3.0] Follicular Cell, Hyperplasia 1 [1.0] 1 [2.0] 1 [1.0] 9 [1.6] Follicular Cell, Hypertrophy 6 [1.2] 3 [1.0] 23 [1.1] 46 [1.7] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (48) (48) (50) Inflammation, Chronic 1 [4.0] Ovary (50) (49) (49) (48) Angiectasis 12 [2.3] 7 [2.4] 8 [2.8] 8 [2.6] Cyst 10 [3.0] 11 [3.0] 15 [3.0] 10 [3.0] Inflammation, Chronic 3 [4.0] 2 [3.0] Thrombosis 1 [4.0] Corpus Luteum, Hyperplasia 1 [3.0] Uterus (50) (49) (49) (50) Angiectasis 3 [3.3] 2 [2.5] 2 [3.5] 6 [2.2] Inflammation, Chronic 6 [2.8] 2 [2.0] 9 [2.7] 4 [3.3] Metaplasia, Squamous 5 [3.0] 5 [3.0] 1 [3.0] Cervix, Cyst Epithelial Inclusion 1 Endometrium, Fibrosis 1 [3.0] Endometrium, Hyperplasia, Cystic 48 [3.0] 47 [3.1] 46 [3.3] 45 [3.4] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (48) (50) Hyperplasia 10 [2.7] 5 [2.0] 13 [3.2] 16 [2.4] Lymph Node (12) (6) (8) (9) Bronchial, Hyperplasia, Lymphoid 1 [3.0] 2 [2.5] Iliac, Ectasia 1 [3.0] Iliac, Hematopoietic Cell Proliferation 2 [2.5] 1 [2.0] 1 [2.0] Iliac, Hyperplasia, Lymphoid 5 [2.2] 3 [3.0] 4 [3.0] 2 [4.0] Iliac, Pigmentation 1 [2.0] Inguinal, Hyperplasia, Lymphoid 1 [2.0] Lumbar, Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 2 [3.0] 2 [3.0] Lumbar, Pigmentation 1 [2.0] Mediastinal, Hyperplasia, Lymphoid 1 [4.0] 1 [3.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 4 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Pancreatic, Hyperplasia, Lymphoid 1 [2.0] Renal, Hematopoietic Cell Proliferation 1 [3.0] 1 [2.0] Renal, Hyperplasia, Lymphoid 3 [2.7] 1 [4.0] 2 [2.5] Lymph Node, Mandibular (48) (48) (46) (48) Atrophy 2 [2.5] Hematopoietic Cell Proliferation 3 [2.3] Hemorrhage 1 [2.0] Hyperplasia, Lymphoid 11 [2.0] 12 [1.8] 10 [2.0] 15 [1.7] Hyperplasia, Plasma Cell 2 [2.0] 1 [3.0] 4 [1.8] Pigmentation 24 [2.2] 20 [2.2] 21 [2.2] 21 [2.1] Lymph Node, Mesenteric (48) (48) (47) (48) Ectasia 1 [2.0] Hematopoietic Cell Proliferation 5 [2.2] 3 [2.3] 3 [2.3] Hemorrhage 1 [2.0] 1 [2.0] Hyperplasia, Lymphoid 3 [2.3] 7 [2.9] 4 [2.5] 6 [2.7] Hyperplasia, Plasma Cell 1 [3.0] Spleen (50) (49) (49) (50) Angiectasis 1 [2.0] Atrophy 1 [1.0] 1 [2.0] Congestion 2 [2.0] Hematopoietic Cell Proliferation 15 [2.1] 20 [2.2] 24 [2.5] 39 [2.4] Hyperplasia, Plasma Cell 1 [3.0] Pigmentation 4 [1.3] 11 [1.5] 34 [1.7] Lymphoid Follicle, Atrophy 1 [2.0] 3 [2.0] 5 [2.6] 4 [3.3] Lymphoid Follicle, Hyperplasia 12 [1.8] 14 [1.8] 13 [2.3] 16 [2.2] Thymus (50) (48) (48) (50) Atrophy 5 [2.6] 2 [2.0] 7 [3.1] 3 [3.0] Hyperplasia, Lymphoid 4 [2.5] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (49) (49) (50) Hyperplasia 2 [2.5] 2 [1.0] Skin (50) (49) (49) (50) Edema 1 [3.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (49) (49) (50) Hyperostosis 9 [1.9] 13 [2.2] 10 [2.2] 11 [2.1] Skeletal Muscle (1) (1) a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 5 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Necrosis 1 [4.0] ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (49) (49) (50) Hemorrhage 1 [1.0] 1 [2.0] Inflammation, Chronic Active 1 [2.0] Vacuolization Cytoplasmic 1 [3.0] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) (49) (50) Edema 2 [2.0] 1 [2.0] Foreign Body 2 2 2 Hemorrhage 4 [1.3] 3 [1.3] 1 [2.0] 4 [1.5] Hyperplasia, Lymphoid 9 [2.2] 6 [2.0] 3 [2.0] 7 [2.3] Infiltration Cellular, Histiocyte 2 [1.5] 2 [2.5] 3 [2.7] Thrombosis 1 [2.0] 1 [1.0] Alveolar Epithelium, Hyperplasia 1 [1.0] 2 [2.0] 3 [2.0] 2 [2.0] Nose (50) (49) (49) (50) Foreign Body 1 ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (49) (49) (50) Atrophy 1 [4.0] Cataract 1 [2.0] 2 [2.5] Inflammation, Chronic 1 [1.0] 2 [2.5] Harderian Gland (50) (49) (49) (50) Hyperplasia 1 [2.0] Hyperplasia, Focal 3 [3.0] 2 [2.0] 1 [2.0] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (49) (49) (50) Cyst 1 [3.0] 2 [3.0] 1 [3.0] 1 [3.0] Hyperplasia, Lymphoid 8 [2.0] 16 [2.1] 8 [2.1] 4 [2.3] Infarct 2 [1.5] 2 [3.0] Inflammation, Chronic 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 6 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Metaplasia, Osseous 1 [2.0] 2 [2.5] Nephropathy 27 [1.1] 17 [1.1] 21 [1.1] 19 [1.0] Papilla, Necrosis 1 [3.0] Renal Tubule, Accumulation, Hyaline Droplet 1 [2.0] 1 [4.0] Renal Tubule, Dilatation 1 [2.0] Renal Tubule, Necrosis 1 [3.0] 1 [2.0] Renal Tubule, Pigmentation 2 [2.5] Urinary Bladder (50) (49) (49) (50) Hyperplasia, Lymphoid 16 [2.3] 16 [2.1] 6 [2.0] 11 [2.3] Inflammation, Chronic 1 [1.0] 1 [2.0] Transitional Epithelium, Hyperplasia 1 [1.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 7 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ 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 [2.0] 1 [2.0] 1 [2.0] 1 [2.0] Intestine Small, Duodenum (49) (49) (45) (50) Epithelium, Hyperplasia 1 [3.0] Intestine Small, Jejunum (50) (49) (46) (50) Hyperplasia, Lymphoid 1 [2.0] 1 [3.0] Infiltration Cellular, Polymorphonuclear 1 [3.0] Intestine Small, Ileum (49) (50) (45) (49) Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] Infiltration Cellular, Polymorphonuclear 1 [2.0] Liver (50) (50) (50) (50) Angiectasis 2 [3.0] 1 [4.0] Basophilic Focus 2 3 1 3 Clear Cell Focus 6 9 6 8 Cyst 1 [3.0] Eosinophilic Focus 3 3 2 6 Hematopoietic Cell Proliferation 1 [3.0] 2 [1.5] 2 [2.0] Hepatodiaphragmatic Nodule 1 Infarct 1 Infiltration Cellular, Mixed Cell 5 [1.4] 7 [1.1] 7 [1.3] 7 [1.4] Mixed Cell Focus 4 3 4 4 Necrosis, Diffuse 1 [3.0] Necrosis, Focal 2 [2.0] 6 [1.5] 2 [2.5] 6 [2.2] Tension Lipidosis 2 1 Hepatocyte, Cytoplasmic Alteration 11 [1.2] 37 [1.8] Hepatocyte, Karyomegaly 10 [1.0] 29 [1.3] Hepatocyte, Vacuolization Cytoplasmic 1 [3.0] 1 [2.0] Kupffer Cell, Pigmentation 1 [3.0] 1 [2.0] 19 [1.5] Mesentery (6) (2) (5) (2) Angiectasis 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 8 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic 1 [1.0] Fat, Necrosis 4 [2.3] 1 [2.0] 3 [2.3] 2 [2.5] Pancreas (50) (50) (49) (50) Atrophy 1 [2.0] 1 [4.0] Cyst 2 [3.0] 3 [3.0] 2 [3.0] Acinus, Cytoplasmic Alteration 2 [2.0] 1 [3.0] Salivary Glands (50) (50) (50) (50) Hyperplasia, Lymphoid 2 [2.0] 2 [2.0] Stomach, Forestomach (50) (49) (50) (50) Diverticulum 2 Inflammation, Chronic Active 1 [2.0] 1 [1.0] Ulcer 1 [3.0] 1 [3.0] Epithelium, Hyperplasia 2 [2.0] 2 [1.5] 1 [2.0] 1 [3.0] Stomach, Glandular (50) (49) (49) (50) Glands, Dysplasia 1 [3.0] Tooth (1) Inflammation, Chronic 1 [4.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Cardiomyopathy 1 [1.0] 1 [1.0] Perivascular, Inflammation, Chronic 3 [1.7] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 2 [3.0] 6 [3.0] 8 [3.0] 6 [3.0] Hyperplasia, Focal 2 [1.5] 4 [1.5] 3 [1.3] 1 [1.0] Hypertrophy, Focal 13 [1.3] 18 [1.6] 10 [1.2] 10 [1.7] Capsule, Hyperplasia 1 [1.0] 2 [1.5] 3 [1.3] 2 [1.5] Adrenal Medulla (50) (50) (50) (50) Hyperplasia 2 [1.5] Islets, Pancreatic (50) (50) (49) (50) Hyperplasia 2 [2.0] 1 [2.0] Parathyroid Gland (49) (47) (45) (48) Cyst 3 [3.0] 1 [3.0] 2 [3.0] 1 [3.0] Pituitary Gland (49) (48) (48) (50) Pars Distalis, Cyst 2 [3.0] 1 [3.0] 2 [3.0] 2 [3.0] Pars Distalis, Hyperplasia, Focal 1 [4.0] Thyroid Gland (50) (50) (50) (50) a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 9 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Degeneration, Cystic 10 [2.0] 2 [1.0] 3 [2.0] 4 [1.5] Follicular Cell, Hyperplasia 2 [1.5] 3 [1.7] 33 [1.9] Follicular Cell, Hypertrophy 1 [1.0] 6 [1.2] 25 [1.3] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Fibrosis 1 [2.0] Granuloma Sperm 3 [2.7] 6 [2.5] Hyperplasia, Lymphoid 2 [2.5] 1 [3.0] Hypospermia 1 [4.0] Inflammation, Chronic Active 1 [1.0] 3 [1.3] 7 [2.0] 8 [2.9] Penis (1) (1) (1) Angiectasis 1 [3.0] 1 [3.0] Preputial Gland (50) (50) (50) (50) Cyst 18 [3.0] 23 [3.0] 16 [3.0] 21 [3.0] Inflammation, Chronic 14 [2.4] 10 [2.2] 14 [2.1] 7 [2.4] Prostate (49) (50) (49) (50) Inflammation, Chronic 2 [2.5] Seminal Vesicle (50) (50) (50) (50) Atrophy 1 [2.0] Testes (50) (50) (50) (50) Germinal Epithelium, Atrophy 1 [2.0] 4 [2.0] 8 [2.3] 14 [2.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hyperplasia 4 [3.0] 10 [2.8] 20 [2.1] 42 [2.5] Lymph Node (2) (3) (1) Bronchial, Hyperplasia, Lymphoid 1 [2.0] Lymph Node, Mandibular (48) (46) (45) (50) Atrophy 1 [3.0] 2 [2.0] 4 [2.8] Ectasia 1 [2.0] Hyperplasia, Lymphoid 10 [2.1] 14 [2.3] 9 [2.6] 13 [2.2] Pigmentation 8 [2.1] 6 [2.2] 9 [2.0] 6 [2.0] Lymph Node, Mesenteric (47) (47) (46) (48) a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 10 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Angiectasis 1 [3.0] Atrophy 1 [2.0] 1 [3.0] 2 [2.5] 2 [3.0] Hemorrhage 4 [1.8] 2 [1.5] 2 [2.0] Hyperplasia, Lymphoid 7 [2.4] 7 [2.1] 15 [2.4] 10 [2.3] Necrosis 1 [4.0] 1 [3.0] Spleen (50) (50) (49) (50) Angiectasis 1 [2.0] Atrophy 1 [3.0] 4 [3.0] 3 [2.7] Hematopoietic Cell Proliferation 10 [2.2] 21 [2.3] 38 [2.5] 45 [2.9] Pigmentation 1 [2.0] 16 [1.1] 33 [1.6] 43 [2.2] Lymphoid Follicle, Atrophy 4 [3.3] 14 [1.6] 30 [1.8] Lymphoid Follicle, Hyperplasia 5 [2.0] 2 [1.5] 2 [2.0] Thymus (47) (46) (46) (47) Atrophy 7 [2.6] 5 [2.2] 9 [3.4] 8 [3.1] Cyst 1 [3.0] 1 [3.0] 1 [3.0] Hyperplasia, Lymphoid 1 [3.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Inflammation, Chronic 1 [4.0] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) (2) Atrophy 1 [2.0] ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Compression 1 [3.0] Peripheral Nerve (1) (1) Atrophy 1 [2.0] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Edema 1 [2.0] 3 [2.0] 1 [2.0] 3 [2.0] Hemorrhage 4 [2.0] 8 [1.5] 4 [1.8] 2 [3.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 11 NTP Experiment-Test: 92012-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 08/06/04 Route: DOSED FEED 2-METHYLIMIDAZOLE Time: 09:44:43 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0PPM 625 PPM 1250 PPM 2500 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Hyperplasia, Lymphoid 1 [2.0] 2 [2.0] 2 [2.0] 4 [2.0] Infiltration Cellular, Histiocyte 4 [2.8] 4 [3.0] 4 [2.0] 2 [3.0] Inflammation, Chronic 1 [1.0] 2 [1.5] Metaplasia, Osseous 2 [1.0] Thrombosis 1 [1.0] 1 [2.0] Alveolar Epithelium, Hyperplasia 5 [3.2] 3 [2.0] 1 [1.0] 3 [2.3] Alveolar Epithelium, Hyperplasia, Multifocal 1 [3.0] Nose (50) (50) (50) (50) Foreign Body 1 3 3 2 Inflammation, Chronic 1 [1.0] 4 [2.5] 3 [1.7] 2 [2.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (50) (50) (50) Cataract 1 [3.0] 1 [2.0] Inflammation, Chronic 1 [3.0] 2 [3.0] 2 [2.0] 2 [3.0] Cornea, Hyperplasia 1 [2.0] 1 [2.0] Harderian Gland (50) (50) (48) (50) Hyperplasia, Focal 1 [2.0] 2 [2.5] Inflammation, Chronic 3 [1.7] 4 [1.8] 2 [2.0] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 13 [3.0] 11 [3.0] 12 [3.0] 19 [3.0] Hydronephrosis 1 [2.0] Hyperplasia, Lymphoid 1 [2.0] 3 [2.0] 3 [2.0] 3 [2.0] Infarct 6 [1.8] 6 [1.8] 6 [2.2] 1 [2.0] Inflammation, Suppurative 1 [4.0] Metaplasia, Osseous 5 [1.8] 3 [1.3] 2 [1.0] 3 [1.7] Nephropathy 34 [1.2] 43 [1.5] 32 [1.5] 31 [1.1] Papilla, Necrosis 1 [2.0] Renal Tubule, Hyperplasia 1 [1.0] 1 [1.0] 2 [1.0] 3 [1.7] Renal Tubule, Pigmentation 1 [2.0] 2 [1.5] 45 [2.5] Urethra (1) Angiectasis 1 [4.0] Inflammation, Suppurative 1 [3.0] Urinary Bladder (50) (50) (50) (50) Transitional Epithelium, Hyperplasia 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------