TDMS Study 05067-09 Pathology Tables
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
CORE STUDY
Facility: Southern Research Institute
Chemical CAS #: 58-55-9
Lock Date: 09/03/93
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: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS 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 17 12 14 7
Natural Death 1 7 3 7
Dosing Accident 1 3
Survivors
Terminal Sacrifice 31 30 33 33
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Inflammation, Focal 1 (2%)
Perforation 1 (2%)
Intestine Large, Colon (50) (47) (50) (50)
Parasite Metazoan 4 (8%) 2 (4%)
Intestine Large, Rectum (50) (47) (50) (50)
Parasite Metazoan 1 (2%) 4 (8%) 2 (4%)
Intestine Large, Cecum (50) (47) (50) (50)
Parasite Metazoan 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 1 (2%) 2 (4%) 1 (2%)
Basophilic Focus 40 (80%) 37 (74%) 31 (62%) 32 (64%)
Clear Cell Focus 3 (6%) 2 (4%)
Eosinophilic Focus 2 (4%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 5 (10%) 4 (8%) 7 (14%) 7 (14%)
Hyperplasia, Focal, Histiocytic 6 (12%) 2 (4%) 1 (2%) 3 (6%)
Hyperplasia, Focal, Lymphoid 4 (8%) 2 (4%) 1 (2%) 4 (8%)
Infiltration Cellular, Mixed Cell 1 (2%) 5 (10%) 4 (8%)
Mineralization, Focal 1 (2%)
Mixed Cell Focus 2 (4%) 5 (10%) 5 (10%) 7 (14%)
Vacuolization Cytoplasmic 4 (8%)
Bile Duct, Hyperplasia 8 (16%) 7 (14%) 4 (8%) 7 (14%)
Centrilobular, Degeneration 1 (2%)
Centrilobular, Necrosis 1 (2%)
Mesentery (11) (12) (8) (4)
Accessory Spleen 1 (9%) 1 (8%) 1 (25%)
Hemorrhage 1 (25%)
Infiltration Cellular, Focal, Mixed Cell 1 (9%)
Inflammation, Chronic 1 (9%)
Necrosis, Fatty 1 (8%)
Artery, Inflammation, Chronic 1 (9%) 2 (25%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Necrosis 6 (55%) 9 (75%) 2 (25%)
Vein, Inflammation, Chronic 1 (13%)
Pancreas (50) (48) (49) (50)
Inflammation, Chronic 1 (2%)
Acinus, Atrophy, Focal 3 (6%) 9 (19%) 10 (20%) 9 (18%)
Acinus, Hyperplasia, Focal 2 (4%) 1 (2%)
Salivary Glands (50) (49) (50) (50)
Duct, Cyst 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Inflammation, Chronic 3 (6%) 1 (2%)
Ulcer 1 (2%)
Epithelium, Hyperplasia 2 (4%) 1 (2%)
Tooth (1)
Developmental Malformation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Thrombosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%) 3 (6%) 2 (4%)
Angiectasis 1 (2%)
Cytoplasmic Alteration, Focal 6 (12%) 2 (4%) 6 (12%) 5 (10%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Adrenal Medulla (50) (49) (50) (49)
Hyperplasia 3 (6%) 4 (8%) 3 (6%) 5 (10%)
Pituitary Gland (47) (50) (49) (49)
Angiectasis 6 (13%) 5 (10%) 6 (12%) 2 (4%)
Fibrosis, Focal 1 (2%)
Metaplasia, Focal, Osseous 1 (2%)
Pars Distalis, Angiectasis 1 (2%) 3 (6%)
Pars Distalis, Cyst 8 (17%) 14 (28%) 7 (14%) 7 (14%)
Pars Distalis, Cytoplasmic Alteration, Focal 2 (4%) 4 (8%) 2 (4%) 4 (8%)
Pars Distalis, Hyperplasia 1 (2%)
Pars Distalis, Hyperplasia, Focal 3 (6%) 1 (2%) 2 (4%) 3 (6%)
Pars Distalis, Necrosis 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 6 (12%) 3 (6%) 1 (2%) 5 (10%)
Follicle, Cyst 1 (2%) 1 (2%) 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Follicular Cell, Hyperplasia 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (49) (50) (50) (50)
Degeneration, Cystic 8 (16%) 6 (12%) 8 (16%) 3 (6%)
Hyperplasia 3 (6%) 1 (2%) 3 (6%) 2 (4%)
Inflammation, Chronic 2 (4%) 2 (4%) 2 (4%)
Ovary (50) (50) (50) (50)
Cyst 3 (6%) 2 (4%) 1 (2%) 2 (4%)
Bilateral, Cyst 1 (2%) 1 (2%)
Uterus (50) (50) (50) (50)
Hemorrhage 1 (2%)
Hydrometra 1 (2%) 3 (6%) 2 (4%) 3 (6%)
Hyperplasia, Cystic 1 (2%)
Cervix, Hypertrophy 2 (4%)
Endometrium, Hyperplasia, Cystic 8 (16%) 7 (14%) 8 (16%) 11 (22%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (49) (50) (50)
Depletion Cellular 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Hyperplasia, Focal, Histiocytic 1 (2%) 4 (8%)
Myelofibrosis 1 (2%) 1 (2%)
Lymph Node (9) (10) (9) (8)
Iliac, Ectasia 1 (11%)
Inguinal, Pigmentation 1 (10%)
Mediastinal, Ectasia 1 (11%)
Mediastinal, Hemorrhage 1 (11%) 2 (25%)
Mediastinal, Pigmentation 4 (44%) 3 (30%) 1 (11%) 2 (25%)
Pancreatic, Ectasia 1 (11%)
Pancreatic, Pigmentation 1 (11%)
Renal, Hyperplasia 1 (10%)
Lymph Node, Mandibular (49) (48) (50) (50)
Congestion 2 (4%)
Ectasia 1 (2%) 1 (2%)
Hemorrhage 3 (6%)
Hyperplasia 1 (2%)
Hyperplasia, Lymphoid 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node, Mesenteric (50) (50) (50) (50)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Pigmentation 2 (4%) 1 (2%) 1 (2%)
Spleen (50) (48) (50) (50)
Hematopoietic Cell Proliferation 5 (10%) 7 (15%) 11 (22%) 3 (6%)
Hemorrhage 1 (2%)
Pigmentation 2 (4%)
Thymus (49) (49) (48) (50)
Angiectasis 1 (2%)
Cyst 1 (2%) 1 (2%) 2 (4%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (49)
Cyst 1 (2%)
Ectasia 26 (52%) 23 (46%) 23 (46%) 20 (41%)
Hyperplasia 5 (10%) 3 (6%) 4 (8%) 6 (12%)
Skin (50) (50) (50) (50)
Inflammation, Chronic, Focal 2 (4%) 1 (2%) 2 (4%)
Ulcer 1 (2%) 3 (6%) 1 (2%)
Subcutaneous Tissue, Fibrosis, Focal 1 (2%)
Subcutaneous Tissue, Hemorrhage, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 5 (10%) 3 (6%) 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Atrophy, Focal 10 (20%) 7 (14%) 7 (14%) 8 (16%)
Hemorrhage, Focal 3 (6%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 2 (4%) 1 (2%) 5 (10%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Inflammation, Chronic 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 3 (6%)
Interstitium, Edema 1 (2%)
Nose (50) (50) (50) (50)
Foreign Body 1 (2%)
Inflammation, Suppurative 3 (6%) 3 (6%) 1 (2%) 2 (4%)
Mucosa, Glands, Dilatation, Focal 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (3) (9) (11)
Cataract 2 (18%)
Inflammation, Chronic 1 (9%)
Cornea, Inflammation, Chronic 2 (18%)
Cornea, Pigmentation 1 (9%)
Retina, Degeneration 1 (9%)
Sclera, Metaplasia, Focal, Osseous 1 (33%) 3 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (48) (50) (49)
Angiectasis 1 (2%)
Cyst 1 (2%) 2 (4%)
Fibrosis, Focal 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%)
Nephropathy 43 (86%) 36 (75%) 41 (82%) 41 (84%)
Papilla, Mineralization, Focal 1 (2%)
Pelvis, Dilatation 1 (2%)
Pelvis, Mineralization 2 (4%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Renal Tubule, Pigmentation 1 (2%)
Ureter (1)
Inflammation, Chronic 1 (100%)
Transitional Epithelium, Hyperplasia 1 (100%)
Urinary Bladder (50) (49) (50) (50)
Calculus Gross Observation 1 (2%) 1 (2%)
Calculus Micro Observation Only 1 (2%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 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 21 11 18 13
Natural Death 5 5 2 13
Dosing Accident 1 1 1
Survivors
Terminal Sacrifice 23 33 29 24
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Focal 1 (2%) 1 (2%)
Perforation 1 (2%) 1 (2%)
Periesophageal Tissue, Inflammation, Focal 1 (2%)
Intestine Large, Rectum (49) (48) (50) (49)
Parasite Metazoan 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Basophilic Focus 25 (50%) 20 (40%) 26 (52%) 14 (28%)
Clear Cell Focus 4 (8%) 2 (4%) 1 (2%) 1 (2%)
Congestion 1 (2%) 2 (4%) 1 (2%)
Degeneration, Cystic 2 (4%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 6 (12%) 2 (4%) 3 (6%) 4 (8%)
Hyperplasia, Focal, Histiocytic 1 (2%)
Infiltration Cellular, Mixed Cell 4 (8%) 3 (6%) 1 (2%) 1 (2%)
Mineralization, Focal 1 (2%) 1 (2%)
Mixed Cell Focus 3 (6%) 3 (6%) 7 (14%) 3 (6%)
Necrosis, Focal 2 (4%)
Vacuolization Cytoplasmic 2 (4%) 1 (2%)
Bile Duct, Hyperplasia 39 (78%) 39 (78%) 31 (62%) 29 (58%)
Mesentery (16) (16) (17) (27)
Accessory Spleen 1 (6%)
Artery, Inflammation, Chronic 2 (13%) 2 (13%) 3 (18%) 15 (56%)
Fat, Necrosis 15 (94%) 12 (75%) 15 (88%) 15 (56%)
Lymphatic, Angiectasis 1 (4%)
Pancreas (50) (50) (50) (50)
Acinus, Atrophy, Focal 19 (38%) 13 (26%) 12 (24%) 9 (18%)
Acinus, Hyperplasia 1 (2%)
Acinus, Hyperplasia, Focal 9 (18%) 5 (10%) 2 (4%)
Stomach, Forestomach (50) (50) (50) (50)
Diverticulum 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Edema 1 (2%)
Erosion 1 (2%)
Inflammation, Chronic 5 (10%) 3 (6%)
Ulcer 2 (4%)
Epithelium, Hyperplasia 6 (12%) 3 (6%)
Stomach, Glandular (50) (49) (50) (50)
Erosion 1 (2%)
Inflammation, Chronic 2 (4%)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Fibrosis, Focal 1 (2%)
Hypertrophy 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Mineralization 1 (2%) 1 (2%)
Pericardium, Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Accessory Adrenal Cortical Nodule 1 (2%) 3 (6%) 3 (6%)
Cytoplasmic Alteration, Focal 3 (6%) 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Infiltration Cellular, Focal, Mixed Cell 1 (2%)
Necrosis, Focal 1 (2%)
Adrenal Medulla (50) (49) (50) (50)
Angiectasis 1 (2%)
Hyperplasia 5 (10%) 9 (18%) 8 (16%) 4 (8%)
Islets, Pancreatic (50) (50) (50) (50)
Hyperplasia 1 (2%)
Pituitary Gland (50) (49) (50) (48)
Angiectasis 2 (4%) 3 (6%) 1 (2%) 1 (2%)
Pars Distalis, Angiectasis 1 (2%)
Pars Distalis, Cyst 2 (4%) 4 (8%) 3 (6%) 2 (4%)
Pars Distalis, Cytoplasmic Alteration, Focal 2 (4%) 3 (6%) 2 (4%) 2 (4%)
Pars Distalis, Degeneration, Focal 1 (2%)
Pars Distalis, Hyperplasia, Focal 4 (8%) 3 (6%) 1 (2%) 3 (6%)
Thyroid Gland (50) (50) (50) (50)
C-Cell, Hyperplasia 6 (12%) 5 (10%) 5 (10%) 2 (4%)
Follicle, Cyst 2 (4%) 4 (8%) 2 (4%) 2 (4%)
Follicle, Pigmentation, Focal 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Granuloma Sperm 1 (2%)
Inflammation, Chronic 3 (6%) 1 (2%)
Preputial Gland (50) (49) (50) (50)
Cyst 1 (2%)
Degeneration, Cystic 10 (20%) 7 (14%) 10 (20%) 4 (8%)
Hyperplasia 3 (6%) 4 (8%)
Inflammation, Chronic 5 (10%) 5 (10%) 8 (16%) 3 (6%)
Prostate (50) (50) (50) (50)
Cyst 1 (2%)
Inflammation, Chronic 30 (60%) 33 (66%) 31 (62%) 20 (40%)
Epithelium, Hyperplasia, Focal 5 (10%) 2 (4%)
Seminal Vesicle (50) (50) (50) (50)
Inflammation, Chronic 1 (2%)
Testes (50) (50) (50) (50)
Cyst 1 (2%)
Germinal Epithelium, Degeneration 2 (4%) 4 (8%) 1 (2%)
Interstitial Cell, Hyperplasia 2 (4%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Myelofibrosis 2 (4%)
Necrosis, Focal 1 (2%)
Lymph Node (13) (11) (12) (9)
Deep Cervical, Hyperplasia 1 (11%)
Iliac, Ectasia 1 (9%)
Iliac, Hyperplasia 1 (8%)
Inguinal, Hyperplasia 1 (9%) 1 (8%)
Inguinal, Hyperplasia, Lymphoid 1 (11%)
Inguinal, Pigmentation 1 (9%)
Mediastinal, Ectasia 1 (9%)
Mediastinal, Hemorrhage 3 (23%) 3 (27%) 5 (42%) 5 (56%)
Mediastinal, Hyperplasia, Lymphoid 1 (8%) 1 (8%)
Mediastinal, Pigmentation 4 (31%) 3 (27%) 2 (17%) 2 (22%)
Pancreatic, Ectasia 1 (8%)
Pancreatic, Hyperplasia, Histiocytic 1 (8%)
Pancreatic, Pigmentation 1 (8%)
Lymph Node, Mandibular (48) (49) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Congestion 1 (2%)
Ectasia 2 (4%) 1 (2%)
Hemorrhage 3 (6%) 6 (12%) 2 (4%)
Hyperplasia 1 (2%) 4 (8%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Lymph Node, Mesenteric (50) (49) (50) (49)
Hyperplasia 1 (2%)
Pigmentation 1 (2%)
Spleen (49) (50) (50) (49)
Fibrosis, Focal 4 (8%) 2 (4%) 2 (4%)
Hematopoietic Cell Proliferation 4 (8%) 1 (2%) 2 (4%)
Hemorrhage 1 (2%)
Necrosis, Focal 1 (2%)
Thymus (49) (47) (47) (50)
Angiectasis 1 (2%) 3 (6%)
Cyst 2 (4%)
Hemorrhage 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (49) (47) (48)
Cyst 1 (2%) 1 (2%)
Ectasia 13 (27%) 10 (20%) 8 (17%) 6 (13%)
Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Inflammation, Chronic, Focal 1 (2%)
Skin (50) (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
Hyperkeratosis 1 (2%)
Inflammation, Chronic, Focal 2 (4%)
Ulcer 1 (2%)
Dermis, Atrophy, Focal 1 (2%)
Epidermis, Hyperplasia, Focal 1 (2%) 1 (2%) 2 (4%)
Hair Follicle, Atrophy 1 (2%)
Subcutaneous Tissue, Edema 1 (2%) 2 (4%)
Subcutaneous Tissue, Hemorrhage, Focal 2 (4%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic,
Focal 4 (8%)
Subcutaneous Tissue, Necrosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Callus 1 (2%)
Cranium, Hemorrhage 1 (2%)
Skeletal Muscle (4) (1) (1)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - CONT
Hemorrhage, Focal 1 (25%) 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49) (50) (49)
Atrophy, Focal 10 (20%) 10 (20%) 8 (16%) 4 (8%)
Hemorrhage, Focal 3 (6%) 3 (6%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 1 (2%) 8 (16%)
Fibrosis, Focal 1 (2%)
Foreign Body 1 (2%) 2 (4%)
Hemorrhage 2 (4%) 3 (6%)
Hyperplasia, Histiocytic 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%) 2 (4%)
Inflammation, Suppurative 2 (4%)
Necrosis, Focal 1 (2%)
Alveolar Epithelium, Hyperplasia 7 (14%) 2 (4%) 2 (4%) 1 (2%)
Interstitium, Edema 1 (2%)
Mediastinum, Inflammation, Acute 1 (2%)
Serosa, Foreign Body 1 (2%) 1 (2%)
Serosa, Inflammation 1 (2%)
Nose (50) (49) (50) (50)
Inflammation, Suppurative 5 (10%) 3 (6%) 7 (14%) 3 (6%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) 1 (2%)
Respiratory Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
External Ear, Inflammation, Chronic, Focal 1 (100%)
Eye (8) (7) (15)
Cataract 1 (13%) 1 (14%)
Hemorrhage 2 (25%)
Retinal Detachment 1 (13%)
Cornea, Pigmentation 1 (13%)
Retina, Degeneration 1 (14%)
Sclera, Metaplasia, Focal, Osseous 1 (13%) 2 (29%) 8 (53%)
Harderian Gland (1)
Hypertrophy 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05067-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC THEOPHYLLINE Date: 07/11/96
Route: GAVAGE Time: 16:17:04
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE 7.5 25 MG/KG 75 MG/KG
CONTROL MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (49) (50) (49)
Congestion 1 (2%)
Cyst 2 (4%) 1 (2%) 1 (2%)
Infarct 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Nephropathy 46 (94%) 44 (90%) 49 (98%) 48 (98%)
Papilla, Mineralization, Focal 1 (2%)
Papilla, Necrosis 1 (2%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 1 (2%)
Renal Tubule, Dilatation 2 (4%)
Renal Tubule, Hyperplasia, Focal 1 (2%)
Renal Tubule, Pigmentation 1 (2%) 1 (2%)
Ureter (1)
Inflammation, Chronic 1 (100%)
Transitional Epithelium, Hyperplasia 1 (100%)
Urinary Bladder (50) (50) (50) (49)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
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