TDMS Study 05161-06 Pathology Tables
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
FINAL#2
Facility: Southern Research Institute
Chemical CAS #: 23246-96-0
Lock Date: 11/17/99
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: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 3.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50
Early Deaths
Moribund Sacrifice 9 25
Natural Death 3 8
Accidently Killed 4
Survivors
Natural Death 1
Terminal Sacrifice 34 16
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (45) (45)
Cyst 1 [1.0] 2 [1.5]
Epithelium, Cytoplasmic Alteration 1 [3.0]
Intestine Large, Colon (49) (47)
Epithelium, Hyperplasia, Focal 1 [2.0]
Intestine Large, Rectum (48) (47)
Inflammation, Chronic, Focal 1 [1.0]
Intestine Large, Cecum (48) (47)
Edema 5 [3.0]
Fibrosis 1 [1.0]
Hemorrhage, Focal 6 [2.3]
Artery, Inflammation, Chronic, Focal 18 [1.7]
Epithelium, Erosion, Focal 6 [1.8]
Intestine Small, Duodenum (47) (46)
Hemorrhage, Focal 2 [2.5]
Necrosis, Focal 2 [3.0]
Artery, Inflammation, Chronic 13 [1.9]
Intestine Small, Ileum (46) (46)
Epithelium, Cyst 1 [2.0]
Peyer's Patch, Hyperplasia, Lymphoid 1 [3.0]
Liver (49) (50)
Angiectasis 2 [2.0] 2 [2.0]
Clear Cell Focus 1
Congestion, Focal 1 [2.0]
Cyst 1 [2.0]
Eosinophilic Focus 2
Fibrosis, Focal 2 [2.0]
Hemorrhage, Focal 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 2
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 3.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hyperplasia, Focal, Lymphoid 2 [2.0]
Infarct 1 [3.0]
Infiltration Cellular, Mixed Cell 29 [1.4] 41 [1.8]
Inflammation, Focal, Suppurative 1 [2.0]
Mineralization, Focal 1 [1.0]
Pigmentation, Focal 1 [2.0]
Thrombosis 1 [2.0]
Artery, Inflammation, Chronic 1 [1.0]
Bile Duct, Hyperplasia 28 [1.9]
Endothelial Cell, Hyperplasia, Focal 1 [3.0]
Hepatocyte, Cytomegaly 49 [2.3]
Hepatocyte, Karyomegaly 49 [2.3]
Hepatocyte, Mixed Cell Focus 1 [2.0]
Hepatocyte, Necrosis, Focal 12 [1.3] 19 [1.5]
Hepatocyte, Vacuolization Cytoplasmic,
Diffuse 8 [3.0] 1 [3.0]
Hepatocyte, Vacuolization Cytoplasmic, Focal 3 [1.7]
Hepatocyte, Centrilobular, Necrosis 1 [3.0]
Hepatocyte, Centrilobular, Vacuolization
Cytoplasmic 3 [2.7]
Hepatocyte, Midzonal, Vacuolization
Cytoplasmic 1 [3.0] 3 [2.0]
Mesentery (23) (29)
Fibrosis, Focal 2 [3.0]
Hemorrhage 1 [3.0]
Inflammation, Chronic 2 [2.5]
Inflammation, Chronic, Focal, Suppurative 1 [2.0]
Inflammation, Suppurative 1 [4.0]
Artery, Inflammation, Chronic, Focal 1 [3.0] 19 [2.5]
Artery, Mineralization, Focal 1 [2.0]
Fat, Necrosis 19 [2.5] 2 [1.0]
Pancreas (49) (50)
Amyloid Deposition 1 [3.0]
Atrophy, Focal 1 [3.0]
Fibrosis, Focal 1 [3.0]
Necrosis, Focal 1 [2.0]
Acinus, Atrophy, Diffuse 1 [4.0]
Acinus, Atrophy, Focal 1 [1.0]
Artery, Inflammation, Chronic 3 [1.3]
Salivary Glands (50) (50)
Artery, Inflammation, Chronic 1 [3.0] 2 [2.5]
Stomach, Forestomach (49) (49)
Inflammation, Focal 2 [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 3
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 3.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Ulcer 1 [2.0]
Epithelium, Cyst 1 [1.0]
Epithelium, Hyperplasia 1 [3.0]
Stomach, Glandular (49) (48)
Cyst 2 [2.0]
Tooth (7)
Malformation 1 [2.0]
Peridontal Tissue, Inflammation, Chronic 6 [1.8]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (2)
Inflammation, Chronic 1 [3.0]
Aorta, Mineralization 1 [3.0]
Heart (50) (50)
Infiltration Cellular, Mixed Cell 3 [1.7] 6 [1.7]
Inflammation, Chronic, Focal 2 [2.0]
Mineralization, Focal 4 [2.3]
Epicardium, Infiltration Cellular, Mixed Cell 1 [3.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50)
Accessory Adrenal Cortical Nodule 2 [1.0]
Angiectasis 1 [4.0]
Cyst 1 [1.0]
Cytoplasmic Alteration 1 [2.0]
Cytoplasmic Alteration, Focal 1 25
Inflammation, Chronic, Focal 6 [2.2]
Thrombosis 1 [3.0]
Bilateral, Hypertrophy, Focal 1 [3.0]
Capsule, Fibrosis, Focal 1 [2.0]
Adrenal Medulla (49) (49)
Atypia Cellular 1 [2.0]
Hyperplasia 1 [2.0]
Parathyroid Gland (47) (46)
Cyst 1 [2.0] 1 [2.0]
Pituitary Gland (48) (49)
Angiectasis 4 [2.5] 1 [2.0]
Pars Distalis, Cytoplasmic Alteration, Focal 3 [2.0] 3 [1.3]
Pars Distalis, Hemorrhage, Focal 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 4
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 3.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia, Focal 1 [2.0]
Rathke's Cleft, Cyst 1 [2.0]
Thyroid Gland (49) (50)
Degeneration, Cystic, Focal 13 [1.8] 21 [1.9]
Inflammation, Chronic, Focal 1 [1.0] 2 [1.5]
Follicle, Cyst 1 [2.0]
Follicular Cell, Cytoplasmic Alteration,
Diffuse 1 [3.0]
Follicular Cell, Hyperplasia 1 [3.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Abdominal, Inflammation 1 [4.0]
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (49)
Degeneration, Cystic 2 [2.5]
Inflammation, Chronic 1 [2.0]
Ovary (49) (48)
Angiectasis 3 [2.7] 1 [3.0]
Cyst 15 [2.6] 15 [2.5]
Cyst, Multiple 2 [2.5]
Hemorrhage 1 [2.0] 1 [3.0]
Inflammation, Suppurative 1 [4.0]
Mineralization 1 [1.0]
Pigmentation, Focal 1 [2.0]
Thrombosis 1 [2.0]
Artery, Inflammation, Chronic 26 [2.6]
Bilateral, Cyst 1 [3.0] 2 [2.5]
Interstitial Cell, Hyperplasia 1 [3.0] 1 [3.0]
Uterus (49) (50)
Angiectasis 1 [3.0] 2 [2.0]
Cyst 1 [3.0]
Hemorrhage 1 [3.0]
Hydrometra 27 [3.0] 19 [2.7]
Inflammation, Suppurative 2 [2.5]
Artery, Inflammation 2 [3.0]
Artery, Inflammation, Chronic, Focal 21 [2.4]
Endometrium, Hyperplasia, Cystic 43 [2.9] 41 [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 5
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 3.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50)
Hyperplasia 2 [3.5] 6 [3.0]
Lymph Node (7) (15)
Hemorrhage 1 [2.0]
Hyperplasia, Histiocytic 1 [3.0]
Hyperplasia, Lymphoid 1 [2.0]
Bronchial, Hyperplasia, Lymphoid 1 [2.0]
Bronchial, Hyperplasia, Plasma Cell 1 [3.0]
Deep Cervical, Hyperplasia, Lymphoid 1 [3.0]
Iliac, Hemorrhage 1 [3.0]
Iliac, Hyperplasia, Plasma Cell 1 [4.0]
Mediastinal, Hyperplasia, Lymphoid 1 [3.0] 1 [3.0]
Mediastinal, Hyperplasia, Plasma Cell 2 [3.0]
Renal, Angiectasis 1 [4.0]
Renal, Hemorrhage 2 [4.0]
Renal, Hyperplasia, Plasma Cell 1 [4.0]
Renal, Inflammation, Suppurative 1 [3.0]
Lymph Node, Mandibular (48) (47)
Fibrosis 1 [4.0]
Hyperplasia, Lymphoid 2 [3.0] 1 [2.0]
Hyperplasia, Plasma Cell 1 [3.0] 1 [3.0]
Lymph Node, Mesenteric (48) (49)
Angiectasis 1 [2.0]
Fibrosis 1 [4.0]
Hematopoietic Cell Proliferation 4 [2.5]
Hemorrhage 4 [2.5]
Hyperplasia, Histiocytic 2 [3.0]
Hyperplasia, Lymphoid 2 [2.5] 2 [2.0]
Hyperplasia, Plasma Cell 3 [3.0] 1 [3.0]
Artery, Inflammation, Chronic 1 [2.0]
Spleen (49) (50)
Fibrosis, Focal 1 [2.0]
Hematopoietic Cell Proliferation 32 [2.6] 43 [3.1]
Hyperplasia, Lymphoid 9 [2.4] 4 [2.5]
Hyperplasia, Plasma Cell 1 [3.0]
Pigmentation 1 [2.0]
Artery, Inflammation, Chronic, Focal 6 [2.0]
Thymus (49) (39)
Angiectasis 1 [3.0]
Atrophy 2 [2.5]
Cyst 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: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 3.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Histiocytic 1 [3.0]
Hyperplasia, Lymphoid 3 [2.3]
Artery, Inflammation, Chronic 1 [1.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (50)
Ectasia 2 [3.0]
Skin (50) (50)
Inflammation, Chronic, Focal 1 [2.0]
Artery, Subcutaneous Tissue, Inflammation,
Chronic 1 [2.0]
Dermis, Edema, Focal 1 [3.0]
Subcutaneous Tissue, Edema 1 [3.0]
Subcutaneous Tissue, Inflammation, Focal,
Suppurative 1 [4.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50)
Cranium, Fibrous Osteodystrophy 1 [2.0]
Vertebra, Hyperostosis, Focal 41 [3.0] 33 [2.9]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50)
Atrophy, Focal 1 [4.0]
Gliosis 1 [1.0]
Hemorrhage, Focal 4 [2.0]
Artery, Meninges, Inflammation, Chronic 1 [3.0]
Peripheral Nerve (6)
Spinal, Ganglion, Inflammation, Chronic 1 [3.0]
Spinal Cord (6)
Hemorrhage, Focal 1 [1.0]
Meninges, Inflammation, Chronic 1 [2.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (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 7
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 3.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Congestion 3 [1.3] 2 [3.0]
Foreign Body 4 [2.5]
Hemorrhage 1 [2.0] 4 [2.3]
Hyperplasia, Focal, Mast Cell 1 [2.0]
Hyperplasia, Histiocytic 2 [2.5] 9 [2.1]
Hyperplasia, Lymphoid 2 [2.0]
Infiltration Cellular, Mixed Cell 3 [2.3]
Pigmentation, Focal 1 [2.0]
Alveolar Epithelium, Hyperplasia 1 [1.0] 6 [1.5]
Artery, Mediastinum, Inflammation, Chronic 2 [2.0]
Interstitium, Edema 1 [3.0]
Mediastinum, Inflammation, Chronic 1 [2.0]
Mediastinum, Inflammation, Suppurative 1 [4.0]
Nose (50) (50)
Nasolacrimal Duct, Inflammation 2 [1.5] 1 [2.0]
Pleura (1)
Inflammation, Suppurative 1 [4.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2)
Atrophy 1 [4.0] 1 [3.0]
Inflammation, Chronic 1 [4.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50)
Atrophy 1 [3.0]
Cyst 3 [2.0] 2 [1.5]
Inflammation, Chronic 1 [2.0]
Metaplasia, Focal, Osseous 1 [1.0] 8 [1.5]
Mineralization, Focal 1 [3.0] 1 [3.0]
Nephropathy 18 [1.3] 47 [3.4]
Artery, Inflammation, Chronic 1 [4.0] 16 [2.1]
Artery, Mineralization 1 [1.0]
Glomerulus, Glomerulosclerosis 40 [2.7]
Pelvis, Dilatation 1 [3.0]
Renal Tubule, Accumulation, Hyaline Droplet 2 [2.5] 14 [2.6]
Renal Tubule, Casts Protein 2 [2.0]
Renal Tubule, Dilatation 2 [1.0] 2 [1.0]
Renal Tubule, Hemorrhage 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: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 3.0
MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Karyomegaly 1 [2.0]
Renal Tubule, Necrosis 1 [2.0]
Renal Tubule, Pigmentation 2 [2.0] 27 [2.8]
Urinary Bladder (50) (48)
Edema 1 [3.0]
Artery, Inflammation, Chronic 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: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 0.1 0.3 1.0 3.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50 50
Early Deaths
Moribund Sacrifice 4 6 3 6 13
Natural Death 6 3 7 6 17
Accidently Killed 1
Survivors
Terminal Sacrifice 39 41 40 38 18
Natural Death 2
Animals Examined Microscopically 50 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (44) (43) (36) (41) (38)
Cyst 1 [2.0]
Intestine Large, Cecum (44) (47) (44) (48) (39)
Diverticulum 1
Edema 1 [3.0] 1 [3.0] 1 [3.0]
Hemorrhage, Focal 1 [2.0]
Intestine Small, Duodenum (45) (48) (47) (47) (40)
Artery, Inflammation, Chronic 1 [2.0]
Intestine Small, Jejunum (45) (47) (44) (47) (39)
Inflammation, Focal 1 [3.0]
Peyer's Patch, Hyperplasia, Lymphoid 1 [3.0]
Intestine Small, Ileum (44) (49) (44) (47) (41)
Inflammation 1 [1.0]
Peyer's Patch, Hyperplasia, Lymphoid 1 [2.0] 2 [3.0]
Liver (50) (50) (50) (50) (50)
Angiectasis 6 [2.3] 3 [2.0]
Atrophy, Focal 1 [3.0] 1 [1.0]
Clear Cell Focus 7 5 4 1
Congestion 1 [3.0]
Congestion, Focal 3 [2.3] 2 [2.5] 4 [2.5]
Cyst 1 [3.0]
Eosinophilic Focus 6 6 2 1
Fibrosis, Focal 1 [1.0] 5 [2.2]
Hematopoietic Cell Proliferation 2 [3.0]
Hemorrhage, Focal 2 [2.5] 1 [3.0] 6 [2.3] 21 [2.8]
Infarct 1 [4.0] 2 [3.5] 3 [4.0]
Infiltration Cellular, Mixed Cell 33 [1.4] 25 [1.3] 14 [1.4] 14 [1.6] 32 [2.3]
Inflammation, Chronic 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 10
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 0.1 0.3 1.0 3.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic, Focal, Suppurative 1 [3.0]
Karyomegaly 1 [1.0]
Metaplasia, Focal, Lipocyte 1 [2.0]
Mixed Cell Focus 3
Thrombosis 1 [3.0] 5 [2.8]
Bile Duct, Hyperplasia 2 [2.0] 1 [1.0] 3 [1.7] 6 [2.3]
Endothelial Cell, Hyperplasia 1 [2.0] 1 [2.0]
Endothelial Cell, Hyperplasia, Focal 2 [1.5]
Hepatocyte, Basophilic Focus 1 [1.0]
Hepatocyte, Cytomegaly 4 [1.5] 4 [1.8] 16 [1.7] 33 [1.7] 43 [2.5]
Hepatocyte, Eosinophilic Focus 2 1 1
Hepatocyte, Karyomegaly 4 [1.5] 4 [1.8] 15 [1.7] 33 [1.8] 43 [2.5]
Hepatocyte, Mixed Cell Focus 1 [2.0]
Hepatocyte, Necrosis, Focal 18 [1.3] 9 [1.3] 5 [1.8] 6 [2.2] 21 [2.6]
Hepatocyte, Syncytial Alteration, Focal 38 [1.2] 30 [1.2] 31 [1.2] 27 [1.0]
Hepatocyte, Vacuolization Cytoplasmic,
Diffuse 3 [2.7]
Hepatocyte, Vacuolization Cytoplasmic, Focal 18 [1.9] 7 [1.7] 3 [1.7] 5 [1.4] 1 [1.0]
Hepatocyte, Periportal, Vacuolization
Cytoplasmic 1 [2.0] 1 [3.0]
Hepatocyte, Centrilobular, Necrosis 1 [3.0] 3 [3.3] 4 [3.3] 10 [3.0]
Hepatocyte, Centrilobular, Vacuolization
Cytoplasmic 1 [2.0] 3 [3.0]
Hepatocyte, Midzonal, Vacuolization
Cytoplasmic 8 [2.0] 14 [2.3] 8 [2.3] 2 [2.5]
Serosa, Fibrosis 1 [3.0]
Sinusoid, Dilatation, Diffuse 1 [4.0]
Mesentery (12) (10) (9) (14) (6)
Angiectasis 1 [2.0] 1 [2.0]
Inflammation, Chronic 1 [2.0]
Artery, Inflammation, Chronic, Focal 2 [2.0] 1 [2.0] 2 [1.5] 1 [2.0]
Fat, Necrosis 9 [2.8] 7 [2.4] 8 [2.8] 3 [2.7] 2 [2.5]
Pancreas (49) (50) (50) (50) (48)
Fibrosis, Focal 1 [2.0]
Necrosis, Focal 1 [2.0]
Acinus, Atrophy, Focal 1 [1.0]
Stomach, Forestomach (49) (50) (50) (50) (49)
Diverticulum 1 [2.0]
Erosion 1 [1.0] 1 [1.0]
Inflammation, Focal 2 [1.5] 1 [2.0] 2 [2.5]
Ulcer 1 [2.0] 1 [3.0]
Epithelium, Hyperplasia 2 [2.0] 2 [2.0] 2 [2.5]
Stomach, Glandular (47) (48) (49) (49) (46)
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: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 0.1 0.3 1.0 3.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Pigmentation, Focal 1 [1.0] 1 [2.0]
Glands, Degeneration, Cystic, Focal 1 [2.0] 1 [2.0]
Tongue (1)
Epithelium, Hyperplasia, Focal 1 [3.0]
Tooth (24) (15) (18) (4) (4)
Malformation 13 [2.2] 3 [2.3] 8 [2.3] 2 [2.0]
Peridontal Tissue, Inflammation, Chronic 16 [2.8] 12 [2.7] 12 [2.8] 4 [3.3] 3 [2.3]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1)
Inflammation, Chronic 1 [3.0]
Heart (50) (50) (50) (50) (50)
Infiltration Cellular, Mixed Cell 2 [1.5] 3 [1.7] 3 [1.0] 3 [1.0] 3 [1.3]
Inflammation, Chronic, Focal 1 [1.0]
Mineralization, Focal 1 [2.0] 4 [1.5]
Artery, Inflammation, Chronic 2 [2.0] 1 [2.0] 2 [2.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (49) (50) (50) (49)
Accessory Adrenal Cortical Nodule 3 [1.0] 1 [1.0] 1 [2.0] 2 [1.0]
Angiectasis 1 [3.0] 1 [2.0]
Cyst 2 [2.0] 1 [3.0]
Cytoplasmic Alteration 2 [3.5]
Cytoplasmic Alteration, Focal 18 [1.3] 7 [1.3] 8 [1.8] 12 [1.9] 18 [1.4]
Fibrosis 1 [2.0]
Hemorrhage 1 [4.0]
Hyperplasia 1 [2.0]
Hyperplasia, Focal 1 [1.0] 1 [3.0]
Hypertrophy 2 [2.0]
Inflammation, Chronic, Focal 1 [2.0]
Bilateral, Capsule, Fibrosis 1 [4.0]
Capsule, Fibrosis, Focal 1 [3.0]
Capsule, Hyperplasia, Focal 5 [2.0] 7 [2.0] 6 [1.7] 1 [2.0]
Parathyroid Gland (41) (50) (44) (47) (45)
Angiectasis 1 [2.0]
Cyst 1 [2.0] 1 [3.0] 2 [3.0]
Pituitary Gland (49) (47) (48) (46) (47)
Pars Distalis, Cyst 5 [1.2] 4 [1.8] 2 [1.5] 2 [1.5] 3 [1.3]
Pars Distalis, Cytoplasmic Alteration, Focal 2 [1.0] 2 [1.5] 1 [1.0] 1 [1.0] 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
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 0.1 0.3 1.0 3.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia, Focal 2 [1.5]
Pars Intermedia, Cyst 1 [2.0]
Thyroid Gland (49) (50) (49) (50) (50)
Degeneration, Cystic, Focal 8 [1.4] 8 [1.5] 12 [1.8] 7 [1.7] 7 [1.9]
Follicle, Cyst 1 [2.0]
Follicular Cell, Hyperplasia 1 [2.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (2) (1) (1)
Pelvic, Hemorrhage 1 [3.0]
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50) (50)
Inflammation, Chronic 1 [2.0]
Preputial Gland (50) (50) (50) (50) (50)
Atrophy 1 [3.0]
Degeneration, Cystic 19 [3.0] 19 [3.0] 16 [3.0] 21 [3.0] 19 [2.9]
Inflammation, Chronic 2 [3.5] 1 [3.0] 2 [2.5] 1 [2.0]
Prostate, NOS (50) (50) (50) (50) (50)
Inflammation, Chronic 2 [1.5]
Epithelium, Hyperplasia, Focal 1 [2.0] 1 [2.0]
Seminal Vesicle (50) (50) (50) (50) (50)
Dilatation 15 [2.8] 13 [2.5] 8 [2.5] 2 [2.0] 1 [4.0]
Inflammation, Chronic 2 [2.5]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50) (50)
Hyperplasia 1 [3.0] 2 [2.5] 1 [3.0]
Lymph Node (2) (3) (4) (7) (4)
Bronchial, Hyperplasia, Lymphoid 1 [2.0]
Bronchial, Hyperplasia, Plasma Cell 1 [3.0]
Iliac, Hemorrhage 1 [3.0]
Inguinal, Inflammation, Chronic, Focal 1 [2.0]
Mediastinal, Hyperplasia, Lymphoid 1 [3.0]
Mediastinal, Hyperplasia, Plasma Cell 1 [3.0]
Pancreatic, Hyperplasia, Lymphoid 1 [2.0] 1 [3.0]
Pancreatic, Hyperplasia, Plasma Cell 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 13
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 0.1 0.3 1.0 3.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node, Mandibular (49) (48) (49) (49) (44)
Hemorrhage 1 [2.0]
Hyperplasia, Lymphoid 1 [3.0] 1 [3.0] 1 [3.0]
Hyperplasia, Plasma Cell 1 [3.0] 1 [3.0] 2 [3.0]
Lymph Node, Mesenteric (49) (48) (48) (50) (50)
Congestion 1 [4.0]
Hematopoietic Cell Proliferation 2 [3.0]
Hemorrhage 1 [3.0] 2 [3.0]
Hyperplasia, Lymphoid 3 [2.3] 2 [3.0] 1 [3.0] 2 [3.0] 4 [2.8]
Hyperplasia, Plasma Cell 2 [3.0] 3 [3.0] 4 [3.0] 1 [3.0]
Infiltration Cellular, Polymorphonuclear 1 [3.0]
Inflammation, Chronic 1 [3.0]
Inflammation, Focal, Suppurative 1 [3.0]
Inflammation, Granulomatous 1 [3.0]
Spleen (49) (49) (50) (50) (49)
Angiectasis 1 [2.0]
Hematopoietic Cell Proliferation 18 [2.3] 16 [2.6] 19 [2.6] 20 [2.7] 33 [2.8]
Hyperplasia, Lymphoid 2 [3.0] 3 [3.0] 3 [2.7]
Hyperplasia, Plasma Cell 1 [2.0]
Necrosis, Focal 1 [3.0]
Artery, Inflammation, Chronic, Focal 1 [2.0]
Thymus (42) (46) (45) (43) (43)
Cyst 6 [1.7] 5 [1.8] 4 [2.0] 1 [2.0] 3 [2.0]
Hyperplasia, Lymphoid 1 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50) (49)
Cyst Epithelial Inclusion 1 [2.0]
Ulcer 1 [2.0]
Subcutaneous Tissue, Edema 2 [2.0] 5 [2.0] 25 [2.0]
Subcutaneous Tissue, Lip, Hyperplasia,
Lymphoid 1 [3.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50) (50)
Cranium, Hyperostosis 1 [3.0]
Vertebra, Hyperostosis, Focal 37 [2.9] 36 [2.8] 37 [2.7] 24 [2.8] 27 [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 14
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 0.1 0.3 1.0 3.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50) (50)
Angiectasis, Focal 1 [2.0]
Atrophy, Focal 1 [3.0]
Hemorrhage, Focal 1 [2.0]
Pigmentation, Focal 1 [2.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50) (50)
Congestion 1 [2.0] 1 [3.0] 2 [3.5] 2 [2.5]
Hemorrhage 1 [2.0] 8 [2.1] 3 [1.7]
Hyperplasia, Focal, Histiocytic 1 [3.0] 1 [2.0]
Hyperplasia, Histiocytic 1 [2.0] 4 [3.0] 1 [1.0]
Infiltration Cellular, Mixed Cell 1 [2.0] 4 [2.0]
Metaplasia, Focal, Osseous 1 [1.0]
Pigmentation, Focal 2 [1.5]
Thrombosis 1 [3.0]
Alveolar Epithelium, Hyperplasia 1 [1.0] 3 [1.7] 3 [2.0] 6 [1.8] 3 [1.3]
Interstitium, Edema 1 [2.0]
Mediastinum, Inflammation, Chronic 1 [3.0]
Nose (50) (50) (50) (50) (50)
Inflammation, Suppurative 1 [3.0] 1 [3.0]
Sinus, Foreign Body 1 [3.0] 1 [3.0]
Sinus, Inflammation, Chronic, Suppurative 1 [3.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Hemorrhage, Focal 1 [2.0]
Zymbal's Gland (1)
Cyst, Squamous 1 [3.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (49) (50) (50) (50)
Atrophy, Focal 1 [3.0]
Congestion 5 [2.4] 3 [2.3] 1 [2.0]
Cyst 8 [1.8] 4 [2.3] 6 [1.8] 7 [1.6] 4 [2.0]
Cyst, Multiple 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 15
NTP Experiment-Test: 05161-06 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 09/04/01
Route: GAVAGE RIDDELLIINE Time: 09:06:02
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 0.1 0.3 1.0 3.0
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Hyperplasia, Lymphoid 1 [2.0]
Infarct 1 [3.0]
Inflammation, Chronic, Focal 1 [2.0] 1 [3.0]
Metaplasia, Focal, Osseous 3 [1.3] 3 [1.3] 10 [1.4] 4 [1.0]
Nephropathy 46 [1.3] 48 [1.5] 48 [1.8] 50 [2.1] 50 [2.8]
Artery, Inflammation, Chronic 2 [1.5] 2 [2.5]
Capsule, Fibrosis 1 [3.0]
Glomerulus, Glomerulosclerosis 1 [1.0] 42 [1.8] 41 [2.5]
Papilla, Necrosis 1 [3.0]
Pelvis, Dilatation 1 [2.0] 1 [2.0] 1 [2.0]
Renal Tubule, Accumulation, Hyaline Droplet 2 [3.0] 1 [3.0] 1 [3.0] 3 [3.0]
Renal Tubule, Dilatation 16 [1.2] 17 [1.1] 24 [1.3] 29 [1.5] 22 [1.9]
Renal Tubule, Karyomegaly 12 [1.4]
Renal Tubule, Necrosis, Focal 1 [2.0]
Renal Tubule, Pigmentation 2 [2.0] 1 [2.0] 2 [2.0]
Renal Tubule, Vacuolization Cytoplasmic 1 [2.0]
Urinary Bladder (50) (50) (50) (50) (50)
Calculus Micro Observation Only 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 16
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