TDMS Study 92013-06 Pathology Tables
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
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 [2.0] 4 [2.0] 2 [2.0] 2 [2.0]
Intestine Small, Jejunum (50) (48) (47) (47)
Hyperplasia, Lymphoid 4 [3.3] 2 [3.5] 2 [2.5]
Intestine Small, Ileum (48) (45) (48) (48)
Hyperplasia, Lymphoid 1 [4.0]
Liver (50) (50) (50) (50)
Angiectasis 2 [2.5]
Basophilic Focus 1 1 1
Cyst 3 [3.0] 1 [3.0]
Eosinophilic Focus 1 2 1
Hematopoietic Cell Proliferation 6 [2.7] 5 [3.4] 3 [2.3]
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 2 [2.0] 3 [3.0] 1 [4.0]
Infiltration Cellular, Mixed Cell 1 [4.0] 3 [2.0] 1 [3.0] 1 [2.0]
Mixed Cell Focus 1 1
Necrosis, Focal 4 [3.3] 3 [1.3] 2 [2.0] 6 [2.7]
Centrilobular, Necrosis 1 [2.0] 1 [3.0] 1 [4.0]
Hepatocyte, Hypertrophy 1 [3.0]
Hepatocyte, Vacuolization Cytoplasmic 1 [3.0] 1 [3.0] 1 [3.0] 1 [4.0]
Kupffer Cell, Pigmentation 1 [2.0] 1 [2.0] 2 [3.0]
Mesentery (3) (7) (7) (4)
Hemorrhage 1 [2.0]
Fat, Necrosis 3 [2.7] 3 [3.0] 3 [3.0] 3 [2.7]
Pancreas (49) (48) (48) (49)
Atrophy 1 [4.0]
Cyst 3 [3.0] 1 [3.0]
Hyperplasia, Lymphoid 1 [2.0] 1 [2.0]
Necrosis 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 2
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Acinus, Cytoplasmic Alteration 1 [3.0] 1 [3.0]
Salivary Glands (50) (48) (50) (49)
Atrophy 2 [2.0]
Hyperplasia, Lymphoid 3 [2.7] 4 [2.5] 3 [2.0] 3 [2.7]
Stomach, Forestomach (50) (50) (50) (50)
Diverticulum 2
Hyperplasia, Squamous 1 [4.0]
Inflammation, Chronic 1 [2.0] 1 [2.0]
Ulcer 1 [2.0] 1 [3.0]
Epithelium, Hyperplasia 3 [2.0] 5 [2.6] 2 [2.0] 5 [1.8]
Stomach, Glandular (49) (49) (50) (49)
Erosion 2 [2.5] 1 [1.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Inflammation, Chronic 1 [2.0] 1 [1.0]
Mineralization 4 [2.0]
Thrombosis 1 [3.0]
Myocardium, Necrosis 1 [2.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 9 9 9 5
Hyperplasia, Diffuse 1 [3.0]
Hyperplasia, Focal 1 [1.0] 2 [2.5]
Capsule, Hyperplasia 2 [2.0]
Adrenal Medulla (50) (50) (50) (50)
Hyperplasia 1 [2.0] 2 [2.5]
Islets, Pancreatic (49) (48) (47) (49)
Hyperplasia 1 [2.0] 2 [2.0]
Parathyroid Gland (49) (49) (48) (47)
Cyst 1 [3.0] 5 [3.0] 2 [3.0]
Pituitary Gland (49) (46) (49) (50)
Pars Distalis, Cyst 1 [3.0] 3 [3.0] 4 [3.0]
Pars Distalis, Hyperplasia, Focal 2 [3.0] 4 [2.0] 1 [2.0]
Thyroid Gland (50) (49) (50) (48)
Follicle, Cyst 20 [1.6] 22 [1.7] 29 [1.8] 30 [2.1]
Follicular Cell, Hyperplasia 1 [2.0] 1 [4.0] 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 3
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
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 [2.0] 3 [2.0] 5 [2.4] 3 [2.3]
Ovary (48) (49) (49) (50)
Angiectasis 9 [2.4] 9 [2.4] 7 [2.9] 6 [2.5]
Cyst 16 [3.0] 20 [3.0] 14 [3.0] 19 [3.0]
Inflammation, Granulomatous 1 [3.0]
Corpus Luteum, Hyperplasia 1 [3.0]
Granulosa Cell, Hyperplasia 1 [2.0] 1 [3.0]
Thecal Cell, Hyperplasia 1 [3.0]
Uterus (50) (50) (50) (50)
Angiectasis 3 [2.3] 3 [2.0]
Hyperplasia, Cystic 45 [3.2] 47 [3.2] 46 [3.0] 47 [3.1]
Inflammation, Chronic 1 [2.0] 1 [3.0] 1 [3.0] 3 [2.7]
Metaplasia, Squamous 2 [2.5] 3 [2.7] 1 [3.0] 5 [2.2]
Thrombosis 1 [4.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hyperplasia 13 [2.9] 13 [2.6] 10 [3.2] 17 [2.4]
Infiltration Cellular, Mast Cell 1 [3.0]
Lymph Node (3) (9) (12) (7)
Bronchial, Hyperplasia, Lymphoid 1 [2.0]
Iliac, Hemorrhage 1 [3.0] 1 [2.0]
Iliac, Hyperplasia, Lymphoid 2 [2.5] 1 [3.0] 1 [3.0]
Iliac, Pigmentation 1 [3.0]
Inguinal, Hyperplasia, Lymphoid 2 [2.5] 1 [3.0]
Mediastinal, Hyperplasia, Lymphoid 2 [2.5]
Renal, Hematopoietic Cell Proliferation 1 [3.0]
Renal, Hyperplasia, Lymphoid 1 [2.0] 1 [3.0]
Renal, Pigmentation 1 [3.0]
Lymph Node, Mandibular (47) (47) (48) (48)
Hematopoietic Cell Proliferation 1 [2.0] 2 [2.5]
Hemorrhage 1 [2.0] 3 [1.7]
Hyperplasia, Lymphoid 6 [2.5] 8 [2.3] 7 [2.7] 13 [2.4]
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: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Pigmentation 12 [2.4] 19 [2.2] 18 [2.2] 19 [2.2]
Lymph Node, Mesenteric (49) (47) (49) (50)
Atrophy 2 [2.5]
Ectasia 1 [4.0] 1 [2.0]
Hematopoietic Cell Proliferation 2 [2.0] 1 [3.0] 2 [1.5]
Hyperplasia, Lymphoid 3 [2.7] 8 [2.3] 9 [2.6] 10 [2.1]
Spleen (49) (49) (49) (49)
Hematopoietic Cell Proliferation 15 [2.8] 16 [2.3] 13 [2.8] 11 [1.9]
Hyperplasia, Lymphoid 8 [3.5] 11 [3.5] 8 [3.8] 11 [3.3]
Pigmentation 1 [3.0] 1 [2.0]
Lymphoid Follicle, Atrophy 1 [3.0] 1 [3.0] 1 [2.0]
Lymphoid Follicle, Hyperplasia 14 [2.3] 12 [2.3] 12 [2.4] 13 [2.4]
Red Pulp, Congestion 1 [3.0]
Thymus (49) (49) (50) (48)
Atrophy 3 [3.0] 6 [2.7] 2 [3.5] 5 [2.8]
Hyperplasia, Lymphoid 3 [2.3] 1 [3.0] 2 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (49)
Galactocele 1
Hyperplasia 16 [1.1] 10 [1.1] 14 [1.1] 24 [1.2]
Skin (50) (50) (50) (50)
Edema 1 [2.0] 1 [2.0]
Epidermis, Hyperplasia 1 [1.0]
Subcutaneous Tissue, Inflammation,
Granulomatous 1 [3.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 10 [2.5] 12 [2.2] 10 [2.4] 6 [2.2]
Skeletal Muscle (1) (1) (2) (2)
Mineralization 1 [2.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Compression 1 [4.0]
Hemorrhage 2 [3.0] 1 [2.0] 2 [1.5]
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: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Peripheral Nerve (2) (2)
Atrophy 1 [3.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Hemorrhage 1 [1.0] 2 [1.5] 3 [1.7] 4 [1.8]
Hyperplasia, Lymphoid 6 [1.8] 6 [2.2] 8 [1.8] 8 [1.8]
Infiltration Cellular, Histiocyte 1 [1.0] 5 [1.4] 1 [1.0] 8 [2.0]
Metaplasia, Osseous 1 [1.0]
Alveolar Epithelium, Hyperplasia 3 [1.7] 2 [2.5] 3 [1.7] 11 [1.9]
Nose (50) (49) (50) (50)
Inflammation, Chronic 1 [3.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50) (50) (50) (50)
Cataract 2 [2.0] 1 [2.0]
Inflammation, Chronic 1 [2.0] 1 [1.0]
Cornea, Hyperplasia 1 [2.0]
Cornea, Mineralization 1 [1.0]
Retina, Degeneration 1 [2.0]
Harderian Gland (50) (50) (50) (50)
Hyperplasia 1 [3.0]
Hyperplasia, Focal 2 [2.0] 3 [2.7] 2 [2.0]
Inflammation, Chronic 1 [3.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50) (50) (50)
Cyst 1 [3.0] 1 [3.0]
Hydronephrosis 1 [2.0]
Hyperplasia, Lymphoid 1 [2.0] 2 [3.0] 6 [2.2] 3 [2.0]
Metaplasia, Osseous 1 [3.0] 1 [2.0] 1 [2.0]
Nephropathy 21 [1.2] 20 [1.3] 17 [1.0] 25 [1.0]
Renal Tubule, Accumulation, Hyaline Droplet 3 [2.7] 2 [3.5] 1 [3.0] 2 [3.5]
Renal Tubule, Hyperplasia 1 [2.0]
Renal Tubule, Necrosis 1 [2.0]
Urinary Bladder (50) (50) (50) (50)
Edema 1 [3.0] 1 [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 6
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 312 PPM 625 PPM 1250 PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 1 [3.0] 3 [2.0] 4 [2.0] 3 [2.0]
Inflammation, Chronic 1 [2.0] 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 7
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
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 [2.0] 1 [2.0] 3 [2.0] 4 [2.0]
Hyperplasia, Lymphoid 1 [4.0]
Inflammation 1 [4.0]
Ulcer 1 [4.0] 1 [4.0]
Intestine Small, Jejunum (48) (47) (48) (50)
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 2 [3.0] 2 [2.5] 3 [2.7] 1 [3.0]
Intestine Small, Ileum (49) (46) (48) (49)
Hyperplasia, Lymphoid 1 [3.0]
Liver (50) (50) (50) (50)
Basophilic Focus 1 1 1
Clear Cell Focus 3 3 2 3
Cyst 1 [3.0] 1 [3.0]
Eosinophilic Focus 5 2 1 1
Hyperplasia, Lymphoid 1 [4.0]
Infiltration Cellular, Mixed Cell 3 [1.7] 1 [2.0]
Mixed Cell Focus 3 7 2
Necrosis, Focal 2 [2.0] 3 [1.0] 2 [2.0]
Tension Lipidosis 1 1
Centrilobular, Necrosis 1 [1.0]
Hepatocyte, Hypertrophy 1 [3.0] 1 [3.0]
Hepatocyte, Vacuolization Cytoplasmic 4 [3.0] 5 [3.4] 2 [3.5]
Mesentery (4) (7) (2) (3)
Hemorrhage 1 [4.0]
Fat, Necrosis 3 [2.7] 3 [2.0] 2 [2.5] 2 [2.0]
Pancreas (49) (49) (50) (50)
Cyst 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 8
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Acinus, Hyperplasia, Focal 1 [2.0]
Stomach, Forestomach (49) (50) (50) (50)
Diverticulum 2 1 1
Erosion 1 [1.0]
Hyperplasia 1 [4.0]
Inflammation, Chronic 2 [2.5]
Ulcer 1 [3.0] 1 [3.0]
Epithelium, Hyperplasia 3 [1.7] 2 [3.5] 4 [2.3]
Stomach, Glandular (49) (50) (49) (50)
Erosion 2 [2.0] 1 [2.0] 1 [2.0]
Glands, Hyperplasia 1 [3.0]
Tooth (4) (3)
Inflammation, Chronic 3 [2.3] 2 [2.5]
Malformation 1
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Inflammation, Chronic 2 [2.5] 2 [1.5] 1 [2.0]
Mineralization 2 [2.0]
Thrombosis 1 [4.0]
Myocardium, Necrosis 1 [3.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 2 4 6 8
Hyperplasia, Focal 3 [1.7] 2 [2.0] 1 [1.0] 1 [1.0]
Hypertrophy, Focal 17 [1.5] 11 [1.9] 10 [1.5] 14 [1.9]
Capsule, Hyperplasia 1 [2.0] 1 [2.0] 2 [2.0] 5 [2.0]
Islets, Pancreatic (49) (49) (50) (50)
Hyperplasia 4 [2.0] 2 [2.0] 1 [2.0]
Parathyroid Gland (47) (49) (49) (49)
Cyst 1 [3.0] 1 [3.0] 1 [3.0]
Pituitary Gland (49) (48) (49) (50)
Pars Distalis, Cyst 1 [3.0] 3 [3.0] 3 [3.0] 2 [3.0]
Thyroid Gland (50) (50) (50) (50)
Follicle, Cyst 13 [1.8] 13 [1.7] 13 [1.8] 14 [2.0]
Follicular Cell, Hyperplasia 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 9
NTP Experiment-Test: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
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 [2.0] 1 [3.0]
Spermatocele 1 [2.0] 1 [3.0]
Preputial Gland (50) (50) (50) (50)
Cyst 29 [3.0] 27 [3.0] 31 [3.0] 36 [2.9]
Inflammation, Chronic 17 [2.1] 19 [2.1] 24 [2.1] 23 [2.1]
Seminal Vesicle (50) (50) (50) (50)
Degeneration 1 [3.0]
Testes (50) (50) (50) (50)
Germinal Epithelium, Atrophy 3 [2.3] 1 [3.0] 3 [2.7]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hyperplasia 13 [2.2] 15 [2.1] 14 [2.4] 15 [2.3]
Lymph Node (2) (2) (1) (2)
Inguinal, Hyperplasia, Lymphoid 1 [2.0]
Inguinal, Pigmentation 1 [3.0]
Pancreatic, Hyperplasia, Lymphoid 1 [2.0]
Lymph Node, Mandibular (48) (50) (48) (45)
Hematopoietic Cell Proliferation 2 [2.0] 1 [2.0]
Hyperplasia, Lymphoid 10 [2.2] 8 [2.3] 9 [2.1] 12 [2.1]
Pigmentation 10 [2.1] 5 [2.2] 7 [2.1] 12 [2.0]
Lymph Node, Mesenteric (49) (48) (48) (50)
Hematopoietic Cell Proliferation 1 [2.0]
Hemorrhage 4 [1.5] 7 [2.0] 4 [1.5] 14 [2.0]
Hyperplasia, Lymphoid 7 [2.6] 4 [2.8] 4 [2.8] 7 [2.6]
Spleen (49) (49) (50) (50)
Angiectasis 1 [3.0] 1 [3.0] 1 [3.0]
Hematopoietic Cell Proliferation 10 [2.4] 14 [2.7] 9 [2.7] 12 [2.7]
Hyperplasia, Lymphoid 1 [4.0] 1 [3.0] 2 [3.0] 2 [4.0]
Lymphoid Follicle, Atrophy 1 [3.0] 1 [4.0] 1 [3.0]
Lymphoid Follicle, Hyperplasia 10 [2.4] 8 [2.1] 2 [2.5] 7 [2.0]
Thymus (48) (49) (45) (45)
Atrophy 7 [2.4] 7 [2.6] 5 [2.6] 8 [2.8]
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: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (49)
Cyst Epithelial Inclusion 1
Edema 2 [2.5]
Ulcer 1 [4.0]
Epidermis, Hyperplasia 2 [1.0] 2 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Fibrous Osteodystrophy 1 [2.0] 1 [2.0]
Skeletal Muscle (1) (2) (1) (1)
Atrophy 1 [2.0]
Necrosis 1 [3.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hemorrhage 1 [2.0]
Inflammation, Chronic 1 [3.0]
Peripheral Nerve (2)
Atrophy 1 [3.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 [2.0] 1 [4.0]
Hemorrhage 3 [1.7] 2 [2.0] 1 [2.0] 5 [1.2]
Hyperplasia, Lymphoid 3 [1.7] 2 [2.0] 6 [1.8] 2 [2.0]
Infiltration Cellular, Histiocyte 5 [2.2] 6 [1.7] 5 [1.8] 11 [1.7]
Metaplasia, Osseous 1 [1.0]
Thrombosis 1 [2.0]
Alveolar Epithelium, Hyperplasia 7 [2.0] 3 [1.0] 1 [2.0] 9 [1.9]
Bronchiole, Epithelium, Hyperplasia 1 [1.0] 1 [1.0]
Nose (50) (50) (50) (50)
Inflammation, Chronic 1 [2.0] 2 [2.5]
____________________________________________________________________________________________________________________________________
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: 92013-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 01/12/04
Route: DOSED FEED 4-METHYLIMIDAZOLE Time: 15:11:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 312 PPM 625 PPM 1250 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (50) (50) (50) (50)
Cataract 1 [3.0] 2 [1.5]
Inflammation, Chronic 1 [1.0] 1 [2.0]
Harderian Gland (50) (50) (50) (50)
Hyperplasia, Focal 1 [3.0] 1 [2.0] 1 [3.0] 3 [2.3]
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URINARY SYSTEM
Kidney (50) (50) (50) (50)
Cyst 13 [3.0] 12 [3.0] 12 [3.0] 7 [3.0]
Hydronephrosis 1 [2.0] 1 [2.0]
Hyperplasia, Lymphoid 2 [2.0] 2 [3.0] 2 [2.0]
Inflammation, Chronic Active 1 [3.0]
Metaplasia, Osseous 2 [2.0] 3 [1.7] 2 [2.0]
Mineralization 2 [3.0]
Nephropathy 34 [1.4] 40 [1.2] 38 [1.3] 35 [1.6]
Renal Tubule, Necrosis 1 [2.0]
Urinary Bladder (50) (49) (49) (50)
Edema 1 [3.0] 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)
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