TDMS Study 92013-06 Pathology Tables
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 FINAL #1 MICE Facility: Southern Research Institute Chemical CAS #: 822-36-6 Lock Date: 09/13/02 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: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 3 4 3 3 Natural Death 4 6 4 7 Survivors Terminal Sacrifice 42 40 41 39 Natural Death 1 2 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (49) (48) (46) (46) Edema 3 (6%) 4 (8%) 2 (4%) 2 (4%) Intestine Small, Jejunum (50) (48) (47) (47) Hyperplasia, Lymphoid 4 (8%) 2 (4%) 2 (4%) Intestine Small, Ileum (48) (45) (48) (48) Hyperplasia, Lymphoid 1 (2%) Liver (50) (50) (50) (50) Angiectasis 2 (4%) Basophilic Focus 1 (2%) 1 (2%) 1 (2%) Cyst 3 (6%) 1 (2%) Eosinophilic Focus 1 (2%) 2 (4%) 1 (2%) Hematopoietic Cell Proliferation 6 (12%) 5 (10%) 3 (6%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 2 (4%) 3 (6%) 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) 3 (6%) 1 (2%) 1 (2%) Mixed Cell Focus 1 (2%) 1 (2%) Necrosis, Focal 4 (8%) 3 (6%) 2 (4%) 6 (12%) Centrilobular, Necrosis 1 (2%) 1 (2%) 1 (2%) Hepatocyte, Hypertrophy 1 (2%) Hepatocyte, Vacuolization Cytoplasmic 1 (2%) 1 (2%) 1 (2%) 1 (2%) Kupffer Cell, Pigmentation 1 (2%) 1 (2%) 2 (4%) Mesentery (3) (7) (7) (4) Hemorrhage 1 (25%) Fat, Necrosis 3 (100%) 3 (43%) 3 (43%) 3 (75%) Pancreas (49) (48) (48) (49) Atrophy 1 (2%) Cyst 3 (6%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Necrosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Cytoplasmic Alteration 1 (2%) 1 (2%) Salivary Glands (50) (48) (50) (49) Atrophy 2 (4%) Hyperplasia, Lymphoid 3 (6%) 4 (8%) 3 (6%) 3 (6%) Stomach, Forestomach (50) (50) (50) (50) Diverticulum 2 (4%) Hyperplasia, Squamous 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Ulcer 1 (2%) 1 (2%) Epithelium, Hyperplasia 3 (6%) 5 (10%) 2 (4%) 5 (10%) Stomach, Glandular (49) (49) (50) (49) Erosion 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Inflammation, Chronic 1 (2%) 1 (2%) Mineralization 4 (8%) Thrombosis 1 (2%) Myocardium, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 9 (18%) 9 (18%) 9 (18%) 5 (10%) Hyperplasia, Diffuse 1 (2%) Hyperplasia, Focal 1 (2%) 2 (4%) Capsule, Hyperplasia 2 (4%) Adrenal Medulla (50) (50) (50) (50) Hyperplasia 1 (2%) 2 (4%) Islets, Pancreatic (49) (48) (47) (49) Hyperplasia 1 (2%) 2 (4%) Parathyroid Gland (49) (49) (48) (47) Cyst 1 (2%) 5 (10%) 2 (4%) Pituitary Gland (49) (46) (49) (50) Pars Distalis, Cyst 1 (2%) 3 (7%) 4 (8%) Pars Distalis, Hyperplasia, Focal 2 (4%) 4 (9%) 1 (2%) Thyroid Gland (50) (49) (50) (48) Follicle, Cyst 20 (40%) 22 (45%) 29 (58%) 30 (63%) Follicular Cell, Hyperplasia 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (49) (50) (50) Inflammation, Chronic 1 (2%) 3 (6%) 5 (10%) 3 (6%) Ovary (48) (49) (49) (50) Angiectasis 9 (19%) 9 (18%) 7 (14%) 6 (12%) Cyst 16 (33%) 20 (41%) 14 (29%) 19 (38%) Inflammation, Granulomatous 1 (2%) Corpus Luteum, Hyperplasia 1 (2%) Granulosa Cell, Hyperplasia 1 (2%) 1 (2%) Thecal Cell, Hyperplasia 1 (2%) Uterus (50) (50) (50) (50) Angiectasis 3 (6%) 3 (6%) Hyperplasia, Cystic 45 (90%) 47 (94%) 46 (92%) 47 (94%) Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) 3 (6%) Metaplasia, Squamous 2 (4%) 3 (6%) 1 (2%) 5 (10%) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hyperplasia 13 (26%) 13 (26%) 10 (20%) 17 (34%) Infiltration Cellular, Mast Cell 1 (2%) Lymph Node (3) (9) (12) (7) Bronchial, Hyperplasia, Lymphoid 1 (8%) Iliac, Hemorrhage 1 (11%) 1 (14%) Iliac, Hyperplasia, Lymphoid 2 (22%) 1 (8%) 1 (14%) Iliac, Pigmentation 1 (14%) Inguinal, Hyperplasia, Lymphoid 2 (22%) 1 (8%) Mediastinal, Hyperplasia, Lymphoid 2 (22%) Renal, Hematopoietic Cell Proliferation 1 (8%) Renal, Hyperplasia, Lymphoid 1 (8%) 1 (14%) Renal, Pigmentation 1 (14%) Lymph Node, Mandibular (47) (47) (48) (48) Hematopoietic Cell Proliferation 1 (2%) 2 (4%) Hemorrhage 1 (2%) 3 (6%) Hyperplasia, Lymphoid 6 (13%) 8 (17%) 7 (15%) 13 (27%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Pigmentation 12 (26%) 19 (40%) 18 (38%) 19 (40%) Lymph Node, Mesenteric (49) (47) (49) (50) Atrophy 2 (4%) Ectasia 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 2 (4%) Hyperplasia, Lymphoid 3 (6%) 8 (17%) 9 (18%) 10 (20%) Spleen (49) (49) (49) (49) Hematopoietic Cell Proliferation 15 (31%) 16 (33%) 13 (27%) 11 (22%) Hyperplasia, Lymphoid 8 (16%) 11 (22%) 8 (16%) 11 (22%) Pigmentation 1 (2%) 1 (2%) Lymphoid Follicle, Atrophy 1 (2%) 1 (2%) 1 (2%) Lymphoid Follicle, Hyperplasia 14 (29%) 12 (24%) 12 (24%) 13 (27%) Red Pulp, Congestion 1 (2%) Thymus (49) (49) (50) (48) Atrophy 3 (6%) 6 (12%) 2 (4%) 5 (10%) Hyperplasia, Lymphoid 3 (6%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (49) (49) Galactocele 1 (2%) Hyperplasia 16 (32%) 10 (20%) 14 (29%) 24 (49%) Skin (50) (50) (50) (50) Edema 1 (2%) 1 (2%) Epidermis, Hyperplasia 1 (2%) Subcutaneous Tissue, Inflammation, Granulomatous 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Hyperostosis 10 (20%) 12 (24%) 10 (20%) 6 (12%) Skeletal Muscle (1) (1) (2) (2) Mineralization 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Compression 1 (2%) Hemorrhage 2 (4%) 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Peripheral Nerve (2) (2) Atrophy 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Hemorrhage 1 (2%) 2 (4%) 3 (6%) 4 (8%) Hyperplasia, Lymphoid 6 (12%) 6 (12%) 8 (16%) 8 (16%) Infiltration Cellular, Histiocyte 1 (2%) 5 (10%) 1 (2%) 8 (16%) Metaplasia, Osseous 1 (2%) Alveolar Epithelium, Hyperplasia 3 (6%) 2 (4%) 3 (6%) 11 (22%) Nose (50) (49) (50) (50) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (50) (50) (50) Cataract 2 (4%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Cornea, Hyperplasia 1 (2%) Cornea, Mineralization 1 (2%) Retina, Degeneration 1 (2%) Harderian Gland (50) (50) (50) (50) Hyperplasia 1 (2%) Hyperplasia, Focal 2 (4%) 3 (6%) 2 (4%) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) (50) Cyst 1 (2%) 1 (2%) Hydronephrosis 1 (2%) Hyperplasia, Lymphoid 1 (2%) 2 (4%) 6 (12%) 3 (6%) Metaplasia, Osseous 1 (2%) 1 (2%) 1 (2%) Nephropathy 21 (43%) 20 (40%) 17 (34%) 25 (50%) Renal Tubule, Accumulation, Hyaline Droplet 3 (6%) 2 (4%) 1 (2%) 2 (4%) Renal Tubule, Hyperplasia 1 (2%) Renal Tubule, Necrosis 1 (2%) Urinary Bladder (50) (50) (50) (50) Edema 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 3 (6%) 4 (8%) 3 (6%) Inflammation, Chronic 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 4 6 8 Moribund Sacrifice 1 3 Survivors Natural Death 1 Terminal Sacrifice 44 44 42 46 Other 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (49) (47) (50) Edema 3 (6%) 1 (2%) 3 (6%) 4 (8%) Hyperplasia, Lymphoid 1 (2%) Inflammation 1 (2%) Ulcer 1 (2%) 1 (2%) Intestine Small, Jejunum (48) (47) (48) (50) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 2 (4%) 2 (4%) 3 (6%) 1 (2%) Intestine Small, Ileum (49) (46) (48) (49) Hyperplasia, Lymphoid 1 (2%) Liver (50) (50) (50) (50) Basophilic Focus 1 (2%) 1 (2%) 1 (2%) Clear Cell Focus 3 (6%) 3 (6%) 2 (4%) 3 (6%) Cyst 1 (2%) 1 (2%) Eosinophilic Focus 5 (10%) 2 (4%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Mixed Cell 3 (6%) 1 (2%) Mixed Cell Focus 3 (6%) 7 (14%) 2 (4%) Necrosis, Focal 2 (4%) 3 (6%) 2 (4%) Tension Lipidosis 1 (2%) 1 (2%) Centrilobular, Necrosis 1 (2%) Hepatocyte, Hypertrophy 1 (2%) 1 (2%) Hepatocyte, Vacuolization Cytoplasmic 4 (8%) 5 (10%) 2 (4%) Mesentery (4) (7) (2) (3) Hemorrhage 1 (25%) Fat, Necrosis 3 (75%) 3 (43%) 2 (100%) 2 (67%) Pancreas (49) (49) (50) (50) Cyst 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Hyperplasia, Focal 1 (2%) Stomach, Forestomach (49) (50) (50) (50) Diverticulum 2 (4%) 1 (2%) 1 (2%) Erosion 1 (2%) Hyperplasia 1 (2%) Inflammation, Chronic 2 (4%) Ulcer 1 (2%) 1 (2%) Epithelium, Hyperplasia 3 (6%) 2 (4%) 4 (8%) Stomach, Glandular (49) (50) (49) (50) Erosion 2 (4%) 1 (2%) 1 (2%) Glands, Hyperplasia 1 (2%) Tooth (4) (3) Inflammation, Chronic 3 (75%) 2 (67%) Malformation 1 (25%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Inflammation, Chronic 2 (4%) 2 (4%) 1 (2%) Mineralization 2 (4%) Thrombosis 1 (2%) Myocardium, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 2 (4%) 4 (8%) 6 (12%) 8 (16%) Hyperplasia, Focal 3 (6%) 2 (4%) 1 (2%) 1 (2%) Hypertrophy, Focal 17 (34%) 11 (22%) 10 (20%) 14 (28%) Capsule, Hyperplasia 1 (2%) 1 (2%) 2 (4%) 5 (10%) Islets, Pancreatic (49) (49) (50) (50) Hyperplasia 4 (8%) 2 (4%) 1 (2%) Parathyroid Gland (47) (49) (49) (49) Cyst 1 (2%) 1 (2%) 1 (2%) Pituitary Gland (49) (48) (49) (50) Pars Distalis, Cyst 1 (2%) 3 (6%) 3 (6%) 2 (4%) Thyroid Gland (50) (50) (50) (50) Follicle, Cyst 13 (26%) 13 (26%) 13 (26%) 14 (28%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Atypia Cellular 1 (2%) 1 (2%) Spermatocele 1 (2%) 1 (2%) Preputial Gland (50) (50) (50) (50) Cyst 29 (58%) 27 (54%) 31 (62%) 36 (72%) Inflammation, Chronic 17 (34%) 19 (38%) 24 (48%) 23 (46%) Seminal Vesicle (50) (50) (50) (50) Degeneration 1 (2%) Testes (50) (50) (50) (50) Germinal Epithelium, Atrophy 3 (6%) 1 (2%) 3 (6%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hyperplasia 13 (26%) 15 (30%) 14 (28%) 15 (30%) Lymph Node (2) (2) (1) (2) Inguinal, Hyperplasia, Lymphoid 1 (50%) Inguinal, Pigmentation 1 (50%) Pancreatic, Hyperplasia, Lymphoid 1 (50%) Lymph Node, Mandibular (48) (50) (48) (45) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) Hyperplasia, Lymphoid 10 (21%) 8 (16%) 9 (19%) 12 (27%) Pigmentation 10 (21%) 5 (10%) 7 (15%) 12 (27%) Lymph Node, Mesenteric (49) (48) (48) (50) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 4 (8%) 7 (15%) 4 (8%) 14 (28%) Hyperplasia, Lymphoid 7 (14%) 4 (8%) 4 (8%) 7 (14%) Spleen (49) (49) (50) (50) Angiectasis 1 (2%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 10 (20%) 14 (29%) 9 (18%) 12 (24%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 2 (4%) 2 (4%) Lymphoid Follicle, Atrophy 1 (2%) 1 (2%) 1 (2%) Lymphoid Follicle, Hyperplasia 10 (20%) 8 (16%) 2 (4%) 7 (14%) Thymus (48) (49) (45) (45) Atrophy 7 (15%) 7 (14%) 5 (11%) 8 (18%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (49) Cyst Epithelial Inclusion 1 (2%) Edema 2 (4%) Ulcer 1 (2%) Epidermis, Hyperplasia 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 1 (2%) 1 (2%) Skeletal Muscle (1) (2) (1) (1) Atrophy 1 (100%) Necrosis 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage 1 (2%) Inflammation, Chronic 1 (2%) Peripheral Nerve (2) Atrophy 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 1 (2%) 1 (2%) Hemorrhage 3 (6%) 2 (4%) 1 (2%) 5 (10%) Hyperplasia, Lymphoid 3 (6%) 2 (4%) 6 (12%) 2 (4%) Infiltration Cellular, Histiocyte 5 (10%) 6 (12%) 5 (10%) 11 (22%) Metaplasia, Osseous 1 (2%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 7 (14%) 3 (6%) 1 (2%) 9 (18%) Bronchiole, Epithelium, Hyperplasia 1 (2%) 1 (2%) Nose (50) (50) (50) (50) Inflammation, Chronic 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4-METHYLIMIDAZOLE Date: 01/12/04 Route: DOSED FEED Time: 14:34:40 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (50) (50) (50) Cataract 1 (2%) 2 (4%) Inflammation, Chronic 1 (2%) 1 (2%) Harderian Gland (50) (50) (50) (50) Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%) 3 (6%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 13 (26%) 12 (24%) 12 (24%) 7 (14%) Hydronephrosis 1 (2%) 1 (2%) Hyperplasia, Lymphoid 2 (4%) 2 (4%) 2 (4%) Inflammation, Chronic Active 1 (2%) Metaplasia, Osseous 2 (4%) 3 (6%) 2 (4%) Mineralization 2 (4%) Nephropathy 34 (68%) 40 (80%) 38 (76%) 35 (70%) Renal Tubule, Necrosis 1 (2%) Urinary Bladder (50) (49) (49) (50) Edema 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------