TDMS Study 93020-08 Pathology Tables
NTP Experiment-Test: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
FINAL #1 MICE
Facility: Southern Research Institute
Chemical CAS #: 693-13-0
Lock Date: 03/14/03
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: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 5 5 6 4
Moribund Sacrifice 12 11 4 5
Accidently Killed 1 1 1
Survivors
Terminal Sacrifice 33 32 38 40
Natural Death 1
Moribund Sacrifice 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (42) (47) (42) (47)
Cyst 1 [1.0]
Intestine Large, Cecum (46) (45) (44) (47)
Cyst 1 [1.0]
Edema 1 [3.0]
Intestine Small, Duodenum (46) (46) (44) (47)
Hyperplasia, Lymphoid 1 [3.0]
Perforation 1 [3.0]
Intestine Small, Jejunum (47) (45) (44) (46)
Inflammation, Focal 1 [2.0]
Epithelium, Hyperplasia, Focal 1 [2.0]
Peyer's Patch, Hyperplasia, Lymphoid 1 [3.0]
Intestine Small, Ileum (46) (44) (45) (47)
Peyer's Patch, Hyperplasia, Lymphoid 1 [3.0]
Liver (50) (50) (50) (50)
Angiectasis, Focal 1 [2.0] 2 [2.5]
Clear Cell Focus 1
Congestion 1 [2.0]
Eosinophilic Focus 6 1 6
Hematopoietic Cell Proliferation 2 [3.0] 1 [2.0]
Hyperplasia, Focal, Lymphoid 1 [2.0] 2 [2.0]
Infiltration Cellular, Polymorphonuclear 1 [3.0] 1 [3.0]
Infiltration Cellular, Mixed Cell 16 [1.6] 9 [1.7] 10 [1.2] 22 [1.2]
Mineralization, Focal 1 [3.0]
Necrosis, Focal 1 [2.0]
Hepatocyte, Basophilic Focus 1 1 1
Hepatocyte, Clear Cell Focus 3 2 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 2
NTP Experiment-Test: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hepatocyte, Eosinophilic Focus 4
Hepatocyte, Karyomegaly 1 [1.0]
Hepatocyte, Mixed Cell Focus 2 1 6
Hepatocyte, Necrosis, Focal 3 [1.3] 3 [3.0] 1 [1.0] 1 [1.0]
Hepatocyte, Vacuolization Cytoplasmic 5 [1.8] 3 [2.3] 1 [1.0] 5 [2.2]
Mesentery (23) (20) (14) (18)
Hemorrhage 1 [3.0]
Infiltration Cellular, Lymphoid 1 [3.0]
Infiltration Cellular, Mixed Cell 1 [3.0]
Inflammation 3 [3.3] 5 [3.2] 1 [2.0]
Artery, Inflammation 1 [2.0]
Fat, Necrosis, Focal 17 [2.6] 13 [2.7] 9 [2.3] 15 [2.3]
Pancreas (50) (48) (50) (50)
Inflammation, Focal 1 [2.0]
Acinus, Atrophy, Diffuse 2 [4.0]
Acinus, Atrophy, Focal 1 [4.0] 2 [3.5] 1 [1.0] 3 [2.7]
Duct, Cyst, Focal, Multiple 2 [3.5] 1 [4.0]
Stomach, Forestomach (50) (49) (50) (50)
Diverticulum 1 [1.0] 1 [1.0]
Erosion 2 [2.0] 2 [1.5]
Inflammation, Focal 1 [2.0] 1 [2.0] 1 [3.0]
Ulcer 1 [2.0] 1 [2.0] 2 [2.5]
Epithelium, Hyperplasia 4 [1.8] 4 [1.8] 2 [2.0] 1 [3.0]
Stomach, Glandular (49) (48) (47) (50)
Erosion 1 [1.0]
Glands, Hyperplasia, Focal 1 [2.0]
Tooth (1) (1) (1) (2)
Malformation 1 [3.0] 1 [3.0]
Peridontal Tissue, Inflammation, Chronic 1 [3.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (49) (50)
Cardiomyopathy 3 [1.7] 1 [1.0] 1 [1.0]
Infiltration Cellular, Polymorphonuclear 1 [2.0]
Infiltration Cellular, Mixed Cell 1 [2.0]
Inflammation, Chronic, Focal 1 [2.0]
Thrombosis 4 [3.0] 2 [3.5]
Artery, 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 3
NTP Experiment-Test: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (49) (50)
Accessory Adrenal Cortical Nodule 2 [1.0] 1 [1.0] 1 [1.0] 3 [1.3]
Angiectasis 1 [2.0]
Cytoplasmic Alteration, Focal 1 [1.0] 2 [1.5] 1 [2.0]
Degeneration, Cystic 1 [2.0] 1 [3.0] 1 [2.0]
Infiltration Cellular, Polymorphonuclear 1 [3.0]
Inflammation, Suppurative 1 [3.0]
Necrosis, Focal 1 [3.0]
Adrenal Medulla (49) (50) (49) (49)
Angiectasis 1 [2.0]
Hyperplasia 1 [2.0]
Inflammation, Suppurative 1 [2.0]
Islets, Pancreatic (50) (49) (50) (50)
Hyperplasia 2 [2.0] 1 [2.0]
Parathyroid Gland (46) (43) (49) (49)
Cyst 2 [2.0] 2 [2.0] 1 [2.0]
Pituitary Gland (48) (50) (50) (46)
Angiectasis 3 [2.0] 1 [2.0] 1 [2.0] 3 [1.7]
Cyst 1 [3.0]
Hemorrhage 1 [3.0]
Pars Distalis, Cytoplasmic Alteration, Focal 2 [1.5] 4 [1.5] 1 [1.0]
Pars Distalis, Degeneration, Cystic, Focal 1 [2.0]
Pars Distalis, Hyperplasia, Focal 3 [2.3] 2 [2.0] 7 [2.0] 3 [2.0]
Pars Intermedia, Hyperplasia, Focal 1 [2.0]
Thyroid Gland (50) (50) (50) (50)
Cyst 2 [2.0] 3 [2.7] 1 [2.0]
Inflammation, Chronic, Focal 1 [1.0]
C-Cell, Hyperplasia 2 [1.5]
Follicle, Degeneration, Cystic, Focal 14 [1.8] 14 [1.9] 18 [1.7] 12 [1.9]
Follicular Cell, Hyperplasia, Focal 1 [1.0] 11 [1.5] 9 [1.3] 4 [1.5]
Follicular Cell, Vacuolization Cytoplasmic,
Focal 1 [2.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (5) (8) (3) (4)
Mediastinum, Infiltration Cellular, Lymphoid 1 [3.0] 1 [2.0]
Mediastinum, Inflammation, Suppurative 1 [3.0] 1 [3.0]
Nasal, Hemorrhage 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: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (46) (48) (48) (47)
Degeneration, Cystic 1 [3.0]
Inflammation, Chronic 1 [3.0]
Ovary (49) (50) (49) (49)
Angiectasis 2 [3.5] 3 [2.7] 1 [4.0] 1 [3.0]
Cyst 14 [2.6] 16 [2.6] 13 [2.8] 18 [2.6]
Hemorrhage 2 [2.5]
Hyperplasia, Lymphoid 1 [3.0]
Inflammation, Suppurative 2 [3.5] 2 [3.0] 2 [3.5]
Thrombosis 2 [3.0] 1 [4.0] 1 [4.0]
Bilateral, Cyst 1 [3.0]
Bilateral, Inflammation, Suppurative 1 [3.0] 1 [3.0]
Interstitial Cell, Hyperplasia 1 [3.0]
Oviduct (3) (1)
Inflammation, Suppurative 3 [3.0]
Uterus (50) (50) (50) (50)
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 1 [3.0] 1 [3.0]
Inflammation, Suppurative 5 [2.6] 8 [3.0] 6 [2.7] 2 [1.5]
Thrombosis 1 [3.0]
Cervix, Hypertrophy 1 [3.0]
Endometrium, Hyperplasia, Cystic 46 [2.7] 44 [2.9] 47 [2.8] 49 [2.8]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50) (50) (49)
Hyperplasia 14 [3.1] 5 [3.4] 10 [2.9] 2 [3.0]
Lymph Node (11) (13) (10) (10)
Hyperplasia, Lymphoid 1 [3.0]
Bronchial, Hyperplasia, Lymphoid 1 [3.0]
Iliac, Ectasia 1 [3.0] 1 [3.0] 3 [2.7]
Iliac, Hemorrhage 2 [3.0]
Iliac, Hyperplasia, Lymphoid 2 [2.5] 2 [3.5] 2 [3.0] 2 [2.5]
Inguinal, Hyperplasia, Lymphoid 1 [3.0]
Mediastinal, Ectasia 1 [3.0]
Mediastinal, Hemorrhage 1 [3.0]
Mediastinal, Hyperplasia 1 [3.0]
Mediastinal, Hyperplasia, Lymphoid 1 [2.0] 2 [3.0] 1 [3.0] 3 [3.0]
Pancreatic, Hemorrhage 1 [3.0]
Pancreatic, Hyperplasia, Lymphoid 1 [3.0] 1 [3.0] 1 [3.0]
Renal, Ectasia 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 5
NTP Experiment-Test: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Renal, Hyperplasia, Lymphoid 1 [3.0] 1 [4.0] 2 [2.5]
Lymph Node, Mandibular (47) (49) (49) (48)
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 6 [3.0] 4 [3.0] 2 [2.5] 1 [3.0]
Lymph Node, Mesenteric (47) (48) (49) (50)
Ectasia 1 [3.0] 1 [3.0] 5 [3.2] 2 [3.0]
Hematopoietic Cell Proliferation 1 [3.0]
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 3 [3.0] 6 [3.2] 2 [3.0] 5 [3.0]
Spleen (49) (49) (50) (50)
Accessory Spleen 1
Atrophy 1 [2.0]
Congestion 1 [3.0]
Hematopoietic Cell Proliferation 24 [2.8] 21 [2.8] 18 [2.6] 13 [2.8]
Hyperplasia, Histiocytic 1 [3.0]
Hyperplasia, Lymphoid 6 [2.7] 12 [2.6] 12 [2.5] 6 [2.3]
Capsule, Inflammation, Chronic, Focal 1 [2.0]
Thymus (46) (48) (44) (47)
Hyperplasia, Lymphoid 5 [2.8] 4 [3.0] 4 [3.0] 1 [3.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (49)
Dilatation 1 [2.0]
Hyperplasia 1 [2.0]
Skin (50) (50) (50) (50)
Ulcer 1 [3.0]
Control Dermis, Hyperplasia, Focal 1 [1.0]
Control Dermis, Inflammation, Focal 1 [2.0] 1 [2.0] 1 [1.0]
Control Epidermis, Hyperplasia, Focal 1 [3.0] 1 [1.0]
Epidermis, Hyperplasia, Focal 1 [3.0]
Site of Application - Dermis, Fibrosis 1 [1.0]
Site of Application - Dermis, Inflammation,
Focal 3 [1.3] 2 [2.5] 7 [1.4] 2 [1.5]
Site of Application - Epidermis, Hyperplasia 5 [2.0] 3 [1.7] 7 [1.4] 7 [1.3]
Site of Application, Ulcer 2 [3.0] 1 [2.0]
Subcutaneous Tissue, Angiectasis, Focal 1 [2.0]
Subcutaneous Tissue, Edema 1 [3.0] 2 [2.5] 1 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
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: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - CONT
Bone (50) (50) (50) (50)
Hyperostosis 3 [2.3] 1 [2.0] 1 [2.0] 2 [2.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Compression, Focal 2 [3.0] 2 [3.5] 1 [3.0]
Hemorrhage, Focal 1 [1.0] 2 [2.0]
Infarct 1
Inflammation, Focal 1 [1.0]
Cerebellum, Hippocampus, Necrosis 1 [2.0]
Cerebrum, Atrophy, Focal 1 [4.0]
Hippocampus, Necrosis, Acute 1 [3.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 2 [3.0] 1 [3.0] 1 [2.0]
Foreign Body 1 [1.0]
Hemorrhage 1 [3.0]
Hyperplasia, Histiocytic 1 [3.0] 1 [3.0]
Infiltration Cellular, Polymorphonuclear 2 [3.0]
Mineralization, Focal 1 [2.0]
Alveolar Epithelium, Hyperplasia, Focal 1 [1.0] 2 [1.0] 1 [2.0] 2 [1.5]
Mediastinum, Hyperplasia, Lymphoid 2 [3.0]
Nose (50) (50) (49) (50)
Inflammation 1 [2.0]
Nasolacrimal Duct, Inflammation 1 [2.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (47) (48) (49) (49)
Atrophy 1 [4.0] 2 [4.0]
Phthisis Bulbi 1
Cornea, Hyperplasia, Squamous 1 [2.0] 1 [1.0]
Cornea, Inflammation, Chronic 1 [2.0]
Iris, Synechia 1
Lens, Cataract 1 [3.0]
Harderian Gland (50) (49) (50) (50)
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 7
NTP Experiment-Test: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Inflammation 2 [2.5]
Epithelium, Hyperplasia, Focal 1 [2.0] 1 [2.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (49) (50) (49)
Congestion 1 [3.0]
Cyst 1 [1.0] 4 [1.8]
Hydronephrosis 1 [3.0] 1 [3.0]
Hyperplasia, Lymphoid 2 [2.5] 2 [2.5] 1 [2.0] 1 [2.0]
Infarct 3 [1.3] 2 [2.0] 1 [2.0] 1 [2.0]
Infiltration Cellular, Polymorphonuclear 1 [2.0]
Infiltration Cellular, Mixed Cell 1 [2.0]
Inflammation 1 [3.0] 1 [3.0]
Metaplasia, Focal, Osseous 5 [1.6] 2 [2.0] 1 [1.0]
Nephropathy 13 [1.1] 8 [1.0] 11 [1.1] 18 [1.2]
Capsule, Congestion 1 [2.0]
Papilla, Necrosis 1 [3.0]
Renal Tubule, Accumulation, Hyaline Droplet 3 [3.0] 1 [2.0] 2 [3.0]
Renal Tubule, Necrosis 1 [4.0]
Renal Tubule, Vacuolization Cytoplasmic,
Focal 1 [2.0] 1 [1.0] 1 [2.0]
Urinary Bladder (50) (50) (49) (50)
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: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 5 1 2 5
Natural Death 6 9 10 8
Accidently Killed 1
Survivors
Terminal Sacrifice 38 40 38 36
Moribund Sacrifice 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (45) (42) (43) (41)
Cyst 1 [2.0] 1 [2.0] 2 [1.5]
Epithelium, Degeneration, Hyaline 1 [3.0] 1 [3.0]
Epithelium, Hyperplasia 1 [3.0]
Intestine Small, Duodenum (46) (44) (44) (40)
Ectopic Tissue 1 [2.0]
Serosa, Inflammation, Chronic 1 [3.0]
Intestine Small, Jejunum (46) (43) (44) (40)
Cyst 1 [3.0]
Inflammation, Focal 1 [3.0] 1 [2.0]
Necrosis 1 [4.0]
Peyer's Patch, Hyperplasia, Lymphoid 1 [3.0] 1 [3.0] 1 [3.0]
Intestine Small, Ileum (46) (44) (44) (40)
Peyer's Patch, Hyperplasia, Lymphoid 1 [3.0]
Liver (50) (50) (50) (49)
Atrophy 1 [2.0]
Basophilic Focus 1
Clear Cell Focus 2 1 1 2
Eosinophilic Focus 2 1 1 4
Fibrosis, Focal 1 [2.0]
Hemorrhage, Focal 1 [3.0]
Hepatodiaphragmatic Nodule 1 [2.0]
Hyperplasia, Focal, Histiocytic 1 [3.0]
Infarct 1 [3.0] 1 [4.0]
Infiltration Cellular, Polymorphonuclear 1 [4.0]
Infiltration Cellular, Mixed Cell 8 [1.4] 5 [1.4] 5 [1.4] 6 [1.3]
Inflammation, Focal, Granulomatous 1 [3.0]
Pigmentation, Focal 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: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Thrombosis 1 [4.0]
Bile Duct, Hyperplasia 1 [2.0] 1 [3.0]
Capsule, Inflammation, Chronic 1 [3.0]
Hepatocyte, Clear Cell Focus 19 17 12 8
Hepatocyte, Eosinophilic Focus 2
Hepatocyte, Mixed Cell Focus 1 2 2
Hepatocyte, Necrosis, Focal 5 [1.8] 3 [2.3] 2 [2.5] 7 [1.9]
Hepatocyte, Vacuolization Cytoplasmic 18 [1.9] 17 [2.0] 17 [1.9] 18 [2.2]
Mesentery (49) (49) (50) (50)
Fibrosis, Focal 1 [2.0]
Inflammation 1 [3.0] 1 [3.0]
Inflammation, Chronic 1 [3.0]
Artery, Inflammation 1 [3.0]
Fat, Necrosis, Focal 4 [2.3] 2 [3.0] 4 [2.0] 4 [2.0]
Pancreas (49) (50) (49) (49)
Inflammation, Focal 1 [2.0]
Necrosis, Focal 1 [3.0] 1 [2.0]
Acinus, Atrophy, Focal 3 [2.7]
Serosa, Inflammation, Chronic 1 [3.0]
Salivary Glands (50) (50) (50) (50)
Atrophy 1 [3.0]
Stomach, Forestomach (50) (50) (50) (50)
Diverticulum 1 [2.0]
Erosion 1 [2.0]
Inflammation, Focal 1 [2.0] 1 [2.0]
Ulcer 1 [2.0]
Epithelium, Cyst 1 [1.0]
Epithelium, Hyperplasia 2 [2.0] 2 [2.0] 3 [1.7] 2 [2.0]
Stomach, Glandular (50) (47) (48) (47)
Erosion 4 [1.5] 1 [1.0] 1 [1.0]
Tooth (18) (11) (15) (12)
Malformation 18 [2.5] 11 [2.5] 15 [2.5] 12 [2.5]
Peridontal Tissue, Inflammation, Chronic 1 [2.0]
Pulp, Inflammation 1 [2.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 1 [2.0] 1 [2.0]
Infiltration Cellular, Mixed Cell 1 [1.0]
Inflammation, Chronic, Focal 1 [1.0]
Thrombosis 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 10
NTP Experiment-Test: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Artery, Inflammation, Chronic 1 [2.0]
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49)
Accessory Adrenal Cortical Nodule 3 [1.0] 2 [1.5] 2 [1.5] 2 [2.0]
Cytoplasmic Alteration, Focal 9 [1.3] 5 [1.2] 7 [1.4] 4 [1.5]
Degeneration, Cystic 1 [1.0]
Hyperplasia, Focal, Histiocytic 1 [2.0]
Hypertrophy 1 [4.0]
Vacuolization Cytoplasmic, Focal 1 [2.0]
Adrenal Medulla (49) (50) (50) (49)
Angiectasis 1 [3.0]
Hyperplasia, Focal 1 [2.0]
Islets, Pancreatic (49) (50) (49) (50)
Hyperplasia 2 [2.5] 2 [2.5] 2 [2.5] 1 [2.0]
Parathyroid Gland (49) (50) (46) (47)
Cyst 1 [1.0] 2 [2.5] 1 [3.0]
Pituitary Gland (48) (47) (50) (49)
Cyst 1 [1.0] 2 [1.0] 3 [1.7] 3 [2.0]
Pars Distalis, Cytoplasmic Alteration, Focal 1 [2.0] 5 [1.4]
Pars Distalis, Hyperplasia, Focal 1 [2.0]
Thyroid Gland (49) (50) (50) (50)
C-Cell, Hyperplasia 1 [2.0] 3 [1.7]
Follicle, Degeneration, Cystic, Focal 4 [2.0] 6 [2.2] 8 [1.8] 6 [1.7]
Follicular Cell, Hyperplasia, Focal 7 [1.9] 7 [1.3] 8 [1.5] 3 [1.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (3) (2)
Hemorrhage 1 [3.0]
Abdominal, Cyst 1 [3.0]
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Granuloma Sperm 1 [3.0] 1 [2.0]
Inflammation, Chronic 1 [2.0] 1 [2.0]
Spermatocele 1 [3.0]
Preputial 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 11
NTP Experiment-Test: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 2 [3.0]
Degeneration, Cystic 3 [2.7] 1 [3.0] 1 [3.0] 4 [3.0]
Hyperplasia, Lymphoid 1 [4.0]
Inflammation, Chronic 11 [3.1] 8 [3.3] 10 [2.9] 6 [3.0]
Prostate (50) (50) (50) (50)
Inflammation 1 [4.0] 2 [3.0]
Epithelium, Hyperplasia, Focal 2 [2.0] 1 [2.0]
Seminal Vesicle (50) (50) (50) (50)
Cyst 1 [3.0]
Testes (50) (50) (50) (50)
Atrophy 1 [2.0] 1 [2.0]
Interstitial Cell, Hyperplasia, Focal 1 [1.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50) (50) (50)
Hyperplasia 9 [2.9] 13 [2.9] 12 [2.9] 7 [2.9]
Thrombosis 1 [1.0]
Lymph Node (6) (5) (5) (4)
Bronchial, Hyperplasia, Lymphoid 1 [3.0]
Iliac, Hyperplasia, Lymphoid 1 [3.0]
Inguinal, Hyperplasia, Lymphoid 2 [3.0] 3 [3.0] 4 [2.8] 1 [3.0]
Mediastinal, Hyperplasia, Lymphoid 1 [2.0]
Pancreatic, Hyperplasia, Lymphoid 1 [3.0] 1 [3.0] 1 [3.0]
Lymph Node, Mandibular (47) (48) (47) (47)
Hyperplasia, Histiocytic 1 [2.0]
Hyperplasia, Lymphoid 1 [3.0] 1 [3.0]
Lymph Node, Mesenteric (50) (48) (49) (48)
Ectasia 1 [3.0]
Hematopoietic Cell Proliferation 1 [3.0]
Hemorrhage 3 [3.0] 1 [3.0] 3 [3.0]
Hyperplasia, Lymphoid 3 [2.7] 2 [3.0] 4 [3.0] 2 [3.5]
Spleen (49) (50) (50) (47)
Atrophy 1 [3.0] 1 [2.0]
Fibrosis, Focal 1 [3.0]
Hematopoietic Cell Proliferation 15 [2.8] 13 [2.6] 14 [2.8] 13 [2.6]
Hyperplasia, Lymphoid 2 [3.0] 5 [2.4] 1 [2.0] 1 [3.0]
Thrombosis 1 [3.0]
Capsule, Inflammation, Chronic 1 [2.0]
Thymus (47) (44) (47) (46)
Cyst 2 [2.0] 1 [2.0] 2 [2.5]
Hyperplasia, Lymphoid 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: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Ulcer 1 [3.0]
Epidermis, Hyperplasia, Focal 1 [1.0] 1 [1.0]
Site of Application - Dermis, Inflammation,
Focal 2 [2.0] 2 [2.0] 9 [1.4] 1 [1.0]
Site of Application - Epidermis, Hyperplasia 2 [2.0] 3 [2.3] 10 [1.8] 1 [1.0]
Site of Application, Ulcer 1 [2.0] 1 [3.0]
Subcutaneous Tissue, Angiectasis, Focal 1 [3.0]
Subcutaneous Tissue, Edema 2 [2.5]
Subcutaneous Tissue, Inflammation, Chronic,
Focal 1 [3.0]
Subcutaneous Tissue, Thrombosis 1 [3.0]
Subcutaneous Tissue, Site of Application,
Infiltration Cellular 1 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 2 [2.0] 2 [2.0] 1 [1.0]
Skeletal Muscle (2) (2) (2) (5)
Inflammation, Chronic 1 [2.0]
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 [2.0] 1 [3.0]
Hyperplasia, Histiocytic 1 [2.0] 1 [1.0] 4 [3.0]
Hyperplasia, Lymphoid 1 [2.0] 1 [1.0]
Inflammation, Chronic, Focal 1 [2.0]
Alveolar Epithelium, Hyperplasia, Focal 4 [1.3] 2 [1.5] 1 [1.0] 3 [1.7]
Mediastinum, Hyperplasia, Lymphoid 1 [2.0]
Nose (49) (50) (50) (50)
Inflammation 2 [2.5] 1 [2.0]
Nasolacrimal Duct, 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 13
NTP Experiment-Test: 93020-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 07/19/04
Route: SKIN APPLICATION DIISOPROPYLCARBODIIMIDE Time: 09:22:22
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Nasolacrimal Duct, Hyperplasia, Focal 1 [2.0] 2 [2.0] 1 [3.0]
Nasolacrimal Duct, Inflammation 1 [2.0] 2 [3.0] 3 [1.7]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (46) (46) (47) (44)
Atrophy 1 [4.0]
Inflammation 1 [2.0]
Cornea, Hyperplasia, Squamous 1 [2.0] 1 [1.0]
Cornea, Inflammation, Chronic 2 [2.0] 3 [2.3] 1 [2.0] 3 [2.7]
Cornea, Necrosis, Focal 1 [3.0] 1 [3.0]
Retrobulbar, Inflammation 1 [2.0]
Harderian Gland (50) (50) (50) (50)
Degeneration, Cystic, Focal 1 [2.0]
Inflammation 1 [4.0] 1 [1.0]
Epithelium, Hyperplasia, Focal 3 [2.0] 3 [1.7] 1 [2.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (48) (50) (48)
Cyst 3 [1.7] 10 [2.0] 5 [2.0] 3 [1.7]
Hydronephrosis 2 [2.5] 1 [3.0]
Infarct 2 [1.5] 3 [2.0] 1 [2.0] 1 [2.0]
Infiltration Cellular, Mixed Cell 1 [2.0]
Inflammation 3 [2.3]
Metaplasia, Focal, Osseous 4 [1.8] 2 [2.0] 1 [1.0]
Nephropathy 46 [1.4] 44 [1.6] 41 [1.6] 40 [1.4]
Pelvis, Dilatation 1 [3.0]
Renal Tubule, Hyperplasia, Focal 2 [1.0] 3 [1.7] 1 [1.0]
Urinary Bladder (50) (50) (49) (50)
Inflammation 1 [3.0] 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 14
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