NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
CORE STUDY
Facility: Southern Research Institute
Chemical CAS #: 58-55-9
Lock Date: 07/14/93
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: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 7 4 11 9
Natural Death 6 9 5 8
Survivors
Terminal Sacrifice 37 37 34 33
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Muscularis, Inflammation, Chronic 1 (2%)
Gallbladder (46) (48) (47) (49)
Inflammation, Chronic 1 (2%) 1 (2%)
Intestine Large, Colon (48) (49) (47) (48)
Inflammation, Chronic 1 (2%)
Polyp Inflammatory 1 (2%)
Intestine Large, Cecum (48) (45) (47) (47)
Inflammation, Chronic 1 (2%)
Intestine Small, Jejunum (47) (46) (47) (43)
Peyer's Patch, Hyperplasia, Lymphoid 2 (4%)
Liver (50) (50) (50) (50)
Angiectasis 1 (2%) 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Eosinophilic Focus 6 (12%) 7 (14%) 5 (10%) 3 (6%)
Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 1 (2%)
Hyperplasia, Focal, Lymphoid 1 (2%) 2 (4%) 1 (2%)
Inflammation, Chronic 3 (6%) 5 (10%) 2 (4%)
Inflammation, Focal 1 (2%) 1 (2%)
Mixed Cell Focus 2 (4%) 1 (2%) 2 (4%) 2 (4%)
Necrosis, Focal 2 (4%) 4 (8%) 2 (4%) 1 (2%)
Pigmentation, Focal 2 (4%) 1 (2%)
Vacuolization Cytoplasmic 6 (12%) 8 (16%) 5 (10%) 2 (4%)
Bile Duct, Cyst 1 (2%)
Centrilobular, Necrosis 1 (2%) 1 (2%) 1 (2%)
Hepatocyte, Karyomegaly 1 (2%)
Mesentery (10) (8) (6) (5)
Hemorrhage 1 (13%)
Inflammation, Chronic 1 (13%)
Fat, Necrosis 8 (80%) 4 (50%) 2 (33%) 2 (40%)
Pancreas (50) (49) (49) (49)
Inflammation, Chronic 1 (2%) 1 (2%)
Necrosis 1 (2%)
Acinus, Atrophy, Focal 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Duct, Cyst 1 (2%) 3 (6%)
Salivary Glands (50) (49) (50) (50)
Fibrosis 1 (2%) 1 (2%) 1 (2%)
Mineralization 1 (2%)
Vacuolization Cytoplasmic 1 (2%) 1 (2%)
Stomach, Forestomach (50) (49) (49) (50)
Cyst 1 (2%)
Edema 1 (2%) 1 (2%)
Ulcer 2 (4%)
Epithelium, Hyperplasia 6 (12%) 6 (12%) 12 (24%) 5 (10%)
Stomach, Glandular (49) (49) (48) (50)
Edema 1 (2%)
Erosion 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 4 (8%) 3 (6%) 5 (10%) 9 (18%)
Glands, Degeneration, Cystic, Focal 11 (22%) 5 (10%) 4 (8%) 3 (6%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (50)
Inflammation, Chronic 1 (2%)
Heart (50) (50) (50) (50)
Inflammation, Chronic, Focal 2 (4%) 1 (2%) 1 (2%)
Mineralization 1 (2%) 1 (2%)
Thrombosis 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (50) (50) (49)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%) 2 (4%)
Cyst 1 (2%) 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%) 3 (6%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Hypertrophy, Focal 1 (2%) 3 (6%) 1 (2%)
Adrenal Medulla (50) (48) (50) (49)
Hyperplasia 1 (2%) 3 (6%)
Islets, Pancreatic (50) (49) (49) (49)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (49) (47) (42) (45)
Cyst 1 (2%) 1 (2%) 2 (5%) 2 (4%)
Infiltration Cellular, Lymphocyte 1 (2%)
Pituitary Gland (49) (45) (50) (48)
Angiectasis 3 (6%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hemorrhage 1 (2%)
Pars Distalis, Angiectasis 1 (2%)
Pars Distalis, Cyst 1 (2%) 4 (9%) 1 (2%)
Pars Distalis, Cytoplasmic Alteration, Focal 3 (6%) 1 (2%) 2 (4%) 2 (4%)
Pars Distalis, Hyperplasia, Focal 4 (8%) 7 (16%) 14 (28%) 6 (13%)
Thyroid Gland (50) (50) (50) (50)
Degeneration, Cystic, Focal 12 (24%) 13 (26%) 10 (20%) 15 (30%)
Inflammation, Chronic, Focal 1 (2%)
Follicle, Cyst 2 (4%) 11 (22%) 5 (10%) 7 (14%)
Follicular Cell, Hyperplasia 7 (14%) 8 (16%) 8 (16%) 11 (22%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (49) (49) (49)
Degeneration, Cystic 7 (14%) 3 (6%) 1 (2%) 6 (12%)
Inflammation, Chronic 1 (2%) 1 (2%)
Ovary (50) (50) (50) (50)
Angiectasis 1 (2%)
Cyst 6 (12%) 5 (10%) 5 (10%) 9 (18%)
Hemorrhage 1 (2%) 2 (4%) 5 (10%) 1 (2%)
Inflammation, Suppurative 2 (4%)
Uterus (50) (50) (50) (50)
Angiectasis 1 (2%)
Cyst 1 (2%) 2 (4%) 1 (2%)
Hemorrhage 2 (4%) 1 (2%) 1 (2%)
Hydrometra 20 (40%) 19 (38%) 18 (36%) 13 (26%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%)
Endometrium, Hyperplasia, Cystic 48 (96%) 41 (82%) 43 (86%) 40 (80%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (50)
Depletion Cellular 1 (2%)
Hyperplasia 4 (8%) 4 (8%) 4 (8%) 2 (4%)
Myelofibrosis 1 (2%)
Necrosis 1 (2%)
Lymph Node (6) (8) (7) (6)
Hyperplasia 1 (14%)
Iliac, Inflammation, Chronic 1 (14%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Inguinal, Hyperplasia, Lymphoid 1 (17%)
Mediastinal, Hemorrhage 1 (17%)
Lymph Node, Mandibular (48) (49) (44) (43)
Ectasia 1 (2%)
Hemorrhage 2 (4%) 2 (4%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 3 (6%) 1 (2%) 1 (2%)
Lymph Node, Mesenteric (48) (46) (48) (45)
Atrophy 1 (2%)
Ectasia 1 (2%)
Hemorrhage 2 (4%) 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Spleen (50) (50) (49) (48)
Congestion 1 (2%)
Depletion Cellular 2 (4%)
Fibrosis, Focal 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 13 (26%) 21 (42%) 19 (39%) 12 (25%)
Hyperplasia, Lymphoid 5 (10%) 3 (6%) 2 (4%) 4 (8%)
Infarct 1 (2%)
Necrosis, Focal 1 (2%)
Thymus (47) (44) (49) (47)
Atrophy 2 (4%) 3 (7%) 2 (4%) 2 (4%)
Cyst 1 (2%) 1 (2%) 2 (4%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (49) (50) (49)
Ectasia 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Hyperplasia 1 (2%) 3 (6%) 2 (4%)
Skin (49) (50) (50) (50)
Inflammation, Chronic, Focal 2 (4%) 2 (4%) 2 (4%)
Ulcer 2 (4%)
Dermis, Fibrosis 2 (4%) 3 (6%)
Epidermis, Hyperplasia, Focal 2 (4%) 1 (2%)
Pinna, Ulcer 1 (2%)
Subcutaneous Tissue, Edema 4 (8%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Fibrous Osteodystrophy 9 (18%) 6 (12%) 11 (22%) 17 (34%)
Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Atrophy, Focal 3 (6%) 1 (2%) 2 (4%) 2 (4%)
Hemorrhage 1 (2%) 1 (2%)
Necrosis 2 (4%)
Spinal Cord (2) (1) (1) (1)
Hemorrhage, Focal 1 (50%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Hemorrhage 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 2 (4%)
Pigmentation 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%)
Nose (50) (50) (50) (50)
Inflammation, Suppurative 1 (2%)
Mucosa, Glands, Dilatation, Focal 2 (4%) 2 (4%) 1 (2%)
Nasolacrimal Duct, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1) (2)
Atrophy 1 (100%)
Cornea, Inflammation, Chronic 1 (100%) 2 (100%)
Harderian Gland (6) (6) (8) (2)
Hyperplasia, Focal 1 (17%)
Inflammation, Chronic, Focal 2 (25%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Congestion 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infarct 1 (2%)
Metaplasia, Focal, Osseous 2 (4%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Nephropathy 25 (50%) 27 (54%) 27 (54%) 25 (50%)
Thrombosis 1 (2%)
Pelvis, Dilatation 1 (2%)
Renal Tubule, Accumulation, Hyaline Droplet 3 (6%)
Renal Tubule, Casts Protein 1 (2%)
Renal Tubule, Degeneration 3 (6%) 1 (2%) 4 (8%)
Renal Tubule, Dilatation 1 (2%) 1 (2%)
Renal Tubule, Mineralization 1 (2%) 1 (2%)
Renal Tubule, Pigmentation 1 (2%) 1 (2%)
Urinary Bladder (49) (49) (49) (50)
Hyperplasia, Lymphoid 2 (4%) 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 5 6 4 15
Moribund Sacrifice 9 9 2 9
Survivors
Terminal Sacrifice 36 35 44 26
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (49) (49) (48) (43)
Inflammation, Chronic 1 (2%)
Intestine Small, Duodenum (48) (49) (49) (41)
Inflammation, Chronic, Focal 1 (2%)
Necrosis, Focal 1 (2%)
Intestine Small, Jejunum (48) (47) (47) (41)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Ileum (48) (48) (47) (38)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 2 (4%)
Basophilic Focus 1 (2%) 1 (2%)
Clear Cell Focus 2 (4%) 2 (4%) 3 (6%)
Congestion 1 (2%)
Eosinophilic Focus 6 (12%) 6 (12%) 9 (18%)
Hepatodiaphragmatic Nodule 1 (2%)
Inflammation, Chronic 24 (48%) 25 (50%) 16 (32%) 3 (6%)
Mineralization, Focal 1 (2%)
Mixed Cell Focus 1 (2%)
Necrosis, Focal 5 (10%) 6 (12%) 3 (6%) 2 (4%)
Vacuolization Cytoplasmic 10 (20%) 11 (22%) 6 (12%) 1 (2%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 1 (2%) 2 (4%) 2 (4%)
Hepatocyte, Hypertrophy 1 (2%) 1 (2%)
Hepatocyte, Karyomegaly 15 (30%) 14 (28%) 12 (24%) 2 (4%)
Mesentery (10) (4) (2)
Hemorrhage 2 (20%)
Inflammation, Chronic 1 (10%) 1 (25%)
Thrombosis 1 (10%)
Artery, Inflammation, Chronic 3 (30%) 1 (25%)
Artery, Thrombosis 1 (10%)
Fat, Necrosis 2 (20%) 1 (25%) 1 (50%)
Pancreas (50) (49) (49) (50)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Acinus, Atrophy, Diffuse 2 (4%)
Acinus, Atrophy, Focal 1 (2%) 1 (2%) 1 (2%)
Artery, Hypertrophy 1 (2%)
Duct, Cyst 1 (2%) 2 (4%)
Salivary Glands (50) (50) (50) (49)
Vacuolization Cytoplasmic 1 (2%)
Stomach, Forestomach (50) (50) (50) (49)
Inflammation, Chronic 1 (2%) 3 (6%) 1 (2%)
Ulcer 1 (2%) 3 (6%)
Epithelium, Hyperplasia 14 (28%) 12 (24%) 16 (32%) 13 (27%)
Stomach, Glandular (50) (49) (49) (43)
Edema 1 (2%)
Erosion 1 (2%)
Hyperplasia 1 (2%)
Mineralization 1 (2%) 4 (8%) 3 (6%) 1 (2%)
Glands, Degeneration, Cystic, Focal 2 (4%) 7 (14%) 1 (2%) 2 (5%)
Tooth (10) (5)
Developmental Malformation 10 (100%) 5 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%)
Mineralization 1 (2%)
Thrombosis 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Cyst 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%) 1 (2%) 2 (4%)
Hyperplasia, Focal 1 (2%) 2 (4%)
Hypertrophy, Focal 6 (12%) 7 (14%) 9 (18%) 7 (14%)
Capsule, Hyperplasia, Focal 2 (4%) 2 (4%)
Adrenal Medulla (49) (50) (49) (49)
Hyperplasia 1 (2%) 1 (2%)
Islets, Pancreatic (50) (49) (50) (50)
Hyperplasia 4 (8%) 2 (4%)
Parathyroid Gland (48) (49) (49) (46)
Cyst 1 (2%) 1 (2%) 2 (4%)
Pituitary Gland (49) (50) (48) (44)
Angiectasis 1 (2%) 1 (2%)
Pars Distalis, Cyst 2 (4%) 2 (4%) 3 (6%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Cytoplasmic Alteration, Focal 2 (4%)
Pars Distalis, Hyperplasia, Focal 1 (2%) 3 (6%) 2 (4%) 2 (5%)
Thyroid Gland (50) (50) (50) (50)
Degeneration, Cystic, Focal 6 (12%) 11 (22%) 10 (20%) 13 (26%)
Follicle, Cyst 1 (2%) 6 (12%) 3 (6%) 2 (4%)
Follicular Cell, Hyperplasia 3 (6%) 1 (2%) 3 (6%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (50) (50) (50)
Granuloma Sperm 1 (2%) 2 (4%)
Inflammation, Chronic 1 (2%)
Spermatocele 1 (2%)
Penis (1)
Angiectasis 1 (100%)
Preputial Gland (49) (48) (50) (50)
Degeneration, Cystic 23 (47%) 31 (65%) 31 (62%) 12 (24%)
Inflammation, Chronic 10 (20%) 8 (17%) 1 (2%) 3 (6%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Prostate (50) (49) (50) (50)
Inflammation, Chronic 1 (2%) 1 (2%)
Epithelium, Hyperplasia, Focal 1 (2%)
Seminal Vesicle (50) (50) (50) (50)
Cyst 1 (2%)
Inflammation, Chronic 2 (4%)
Testes (50) (50) (50) (50)
Cyst 1 (2%)
Mineralization, Focal 1 (2%) 1 (2%)
Germinal Epithelium, Degeneration 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (49)
Angiectasis 1 (2%)
Depletion Cellular 1 (2%)
Hyperplasia 5 (10%) 2 (4%)
Lymph Node (5) (6) (5) (3)
Bronchial, Hyperplasia, Lymphoid 1 (33%)
Inguinal, Hyperplasia, Lymphoid 1 (20%) 2 (33%) 1 (33%)
Inguinal, Pigmentation 1 (33%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Hemorrhage 1 (20%)
Pancreatic, Hyperplasia, Lymphoid 2 (33%)
Renal, Hyperplasia 1 (17%)
Lymph Node, Mandibular (42) (47) (47) (47)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Necrosis 1 (2%)
Lymph Node, Mesenteric (50) (46) (50) (48)
Atrophy 2 (4%)
Ectasia 3 (6%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 17 (34%) 13 (28%) 9 (18%) 6 (13%)
Hyperplasia, Lymphoid 1 (2%) 3 (6%) 2 (4%)
Pigmentation 1 (2%)
Spleen (50) (49) (50) (49)
Depletion Cellular 1 (2%) 12 (24%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 20 (40%) 27 (55%) 25 (50%) 13 (27%)
Hyperplasia, Lymphoid 1 (2%)
Thymus (43) (42) (44) (46)
Atrophy 2 (5%) 6 (14%) 4 (9%) 5 (11%)
Cyst 6 (14%) 6 (14%) 5 (11%) 3 (7%)
Necrosis 1 (2%) 1 (2%) 11 (24%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (50)
Inflammation, Chronic, Focal 1 (2%)
Dermis, Fibrosis 1 (2%)
Epidermis, Hyperplasia, Focal 1 (2%)
Subcutaneous Tissue, Edema 1 (2%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Cranium, Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hemorrhage 1 (2%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05067-10 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/03/96
Route: GAVAGE Time: 13:10:54
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 15 MG/KG 50 MG/KG 150
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 4 (8%)
Foreign Body 1 (2%)
Hemorrhage 3 (6%) 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 4 (8%) 4 (8%) 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 2 (4%) 1 (2%)
Nose (50) (50) (50) (50)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (1) (4) (2) (2)
Inflammation, Chronic, Focal 1 (25%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Congestion 1 (2%) 1 (2%)
Cyst 2 (4%) 1 (2%) 2 (4%)
Infarct 2 (4%) 2 (4%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%)
Metaplasia, Focal, Osseous 1 (2%) 2 (4%) 1 (2%)
Nephropathy 46 (92%) 46 (94%) 45 (90%) 29 (58%)
Papilla, Necrosis 1 (2%)
Renal Tubule, Degeneration 7 (14%)
Renal Tubule, Dilatation 4 (8%)
Urethra (3) (3) (1)
Inflammation, Chronic 1 (33%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------