TDMS Study 89006-04 Pathology Tables
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
Facility: Southern Research Institute
Chemical CAS #: 30516-871
Lock Date: 11/01/93
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: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 8 7 6 8
Natural Death 5 5 6 9
Dosing Accident 2
Accidently Killed 1
Survivors
Terminal Sacrifice 37 37 36 32
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (49) (49)
Necrosis 2 (4%)
Perforation 2 (4%)
Muscularis, Inflammation, Chronic 2 (4%)
Periesophageal Tissue, Inflammation, Chronic 1 (2%)
Intestine Small, Duodenum (48) (48) (47) (47)
Hyperplasia, Adenomatous 1 (2%)
Intestine Small, Jejunum (47) (46) (46) (45)
Hyperplasia, Adenomatous 1 (2%)
Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Intestine Small, Ileum (47) (46) (46) (45)
Amyloid Deposition 1 (2%)
Hyperplasia, Adenomatous 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 1 (2%) 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Clear Cell Focus 2 (4%) 1 (2%)
Congestion 1 (2%)
Eosinophilic Focus 4 (8%) 6 (12%) 5 (10%) 2 (4%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%)
Hemorrhage 1 (2%)
Hyperplasia, Focal, Lymphoid 1 (2%) 1 (2%)
Inflammation, Chronic 10 (20%) 6 (12%) 6 (12%) 6 (12%)
Mixed Cell Focus 2 (4%) 3 (6%) 2 (4%) 2 (4%)
Necrosis, Focal 2 (4%) 2 (4%) 2 (4%) 3 (6%)
Vacuolization Cytoplasmic 2 (4%) 6 (12%) 2 (4%) 3 (6%)
Bile Duct, Hyperplasia 1 (2%)
Centrilobular, Necrosis 1 (2%)
Hepatocyte, Karyomegaly 1 (2%) 1 (2%) 1 (2%)
Mesentery (10) (12) (9) (10)
Hemorrhage 1 (10%) 2 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic 1 (10%) 1 (8%)
Fat, Necrosis 7 (70%) 9 (75%) 5 (56%) 5 (50%)
Pancreas (48) (50) (50) (49)
Inflammation, Chronic 1 (2%)
Necrosis 1 (2%)
Acinus, Atrophy, Diffuse 1 (2%) 1 (2%)
Acinus, Atrophy, Focal 2 (4%) 1 (2%)
Duct, Cyst 1 (2%) 1 (2%) 3 (6%)
Salivary Glands (50) (49) (50) (48)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (50) (50) (49) (48)
Cyst 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Epithelium, Hyperplasia 3 (6%) 2 (4%) 1 (2%) 1 (2%)
Stomach, Glandular (49) (50) (48) (49)
Edema 1 (2%) 1 (2%)
Mineralization 1 (2%)
Glands, Degeneration, Cystic, Focal 5 (10%) 1 (2%) 8 (17%) 8 (16%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Inflammation, Chronic, Focal 2 (4%) 1 (2%)
Thrombosis 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (49) (50) (49)
Accessory Adrenal Cortical Nodule 1 (2%) 3 (6%)
Cyst 1 (2%) 1 (2%)
Hyperplasia, Focal 3 (6%) 4 (8%) 1 (2%) 4 (8%)
Hypertrophy, Focal 2 (4%) 2 (4%)
Islets, Pancreatic (48) (49) (50) (48)
Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Parathyroid Gland (43) (43) (45) (46)
Cyst 1 (2%)
Pituitary Gland (49) (44) (48) (44)
Angiectasis 4 (8%) 1 (2%) 4 (8%) 3 (7%)
Pars Distalis, Cyst 1 (2%) 1 (2%) 3 (7%)
Pars Distalis, Cytoplasmic Alteration, Focal 2 (5%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 8 (16%) 7 (16%) 8 (17%) 8 (18%)
Rathke's Cleft, Cyst 1 (2%) 3 (7%)
Thyroid Gland (49) (50) (50) (50)
Degeneration, Cystic, Focal 19 (39%) 16 (32%) 14 (28%) 12 (24%)
Inflammation, Chronic, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Follicle, Cyst 7 (14%) 6 (12%) 9 (18%) 7 (14%)
Follicular Cell, Hyperplasia 21 (43%) 19 (38%) 17 (34%) 17 (34%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (50) (50) (49)
Degeneration, Cystic 3 (6%) 1 (2%) 3 (6%) 3 (6%)
Inflammation, Chronic 1 (2%)
Ovary (50) (49) (49) (50)
Cyst 10 (20%) 6 (12%) 5 (10%) 13 (26%)
Hemorrhage 2 (4%) 1 (2%) 4 (8%)
Mineralization 1 (2%) 1 (2%)
Thrombosis 1 (2%) 1 (2%)
Bilateral, Cyst 1 (2%)
Uterus (50) (50) (50) (50)
Angiectasis 2 (4%)
Cyst 1 (2%) 2 (4%)
Hemorrhage 1 (2%) 1 (2%)
Hydrometra 19 (38%) 21 (42%) 13 (26%) 15 (30%)
Thrombosis 1 (2%) 1 (2%)
Endometrium, Hyperplasia, Cystic 42 (84%) 37 (74%) 41 (82%) 45 (90%)
Vagina (50) (48) (48) (50)
Epithelium, Hyperplasia 1 (2%) 3 (6%) 7 (15%) 12 (24%)
Epithelium, Hyperplasia, Atypical 1 (2%) 1 (2%) 3 (6%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (48)
Angiectasis 1 (2%)
Depletion Cellular 2 (4%)
Hyperplasia 1 (2%) 4 (8%) 4 (8%) 4 (8%)
Lymph Node (8) (7) (4) (6)
Iliac, Hemorrhage 1 (13%)
Renal, Hemorrhage 1 (17%)
Lymph Node, Mandibular (46) (46) (48) (44)
Hemorrhage 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%) 3 (6%) 1 (2%)
Infiltration Cellular, Mast Cell 1 (2%)
Lymph Node, Mesenteric (48) (49) (48) (49)
Ectasia 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hemorrhage 4 (8%) 2 (4%) 7 (15%) 6 (12%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Spleen (49) (49) (49) (49)
Depletion Cellular 1 (2%) 1 (2%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 23 (47%) 15 (31%) 12 (24%) 17 (35%)
Hyperplasia, Lymphoid 5 (10%) 4 (8%) 8 (16%) 3 (6%)
Thymus (47) (46) (48) (48)
Atrophy 3 (7%) 1 (2%) 2 (4%)
Cyst 3 (6%) 4 (9%) 4 (8%) 2 (4%)
Hyperplasia, Lymphoid 2 (4%)
Inflammation, Granulomatous 1 (2%)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (50)
Ectasia 1 (2%)
Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Skin (50) (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
Edema 3 (6%) 3 (6%) 1 (2%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%) 2 (4%)
Ulcer 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic
Active 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Fibrous Osteodystrophy 2 (4%)
Hyperostosis 48 (96%) 40 (80%) 36 (72%) 43 (86%)
Cranium, Fibrous Osteodystrophy 1 (2%)
Femur, Fibrous Osteodystrophy 1 (2%) 2 (4%) 2 (4%)
Femur, Osteopetrosis 1 (2%)
Skeletal Muscle (47) (50) (49) (50)
Hemorrhage, Focal 1 (2%)
Inflammation, Suppurative 1 (2%)
Regeneration 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Atrophy, Focal 2 (4%) 4 (8%) 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Meninges, Inflammation, Chronic 1 (2%) 1 (2%)
Spinal Cord (2) (1) (4)
Cyst Epithelial Inclusion 1 (50%) 1 (25%)
Hemorrhage, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 2 (4%)
Hemorrhage 3 (6%) 2 (4%) 3 (6%)
Hyperplasia, Histiocytic 2 (4%) 3 (6%) 1 (2%) 1 (2%)
Metaplasia, Osseous 1 (2%)
Pigmentation 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (4%) 1 (2%) 2 (4%)
Mediastinum, Inflammation, Chronic 1 (2%)
Nose (50) (50) (50) (50)
Inflammation, Suppurative 1 (2%) 1 (2%)
Mucosa, Glands, Dilatation, Focal 3 (6%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (1)
Fibrosis 1 (50%)
Cornea, Inflammation, Chronic 1 (100%)
Harderian Gland (5) (2) (2) (1)
Hyperplasia, Focal 1 (20%)
Inflammation, Chronic, Focal 1 (20%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (49)
Congestion 1 (2%)
Infarct 1 (2%) 1 (2%) 1 (2%)
Metaplasia, Focal, Osseous 3 (6%) 2 (4%)
Nephropathy 35 (70%) 33 (66%) 39 (78%) 33 (67%)
Pelvis, Dilatation 1 (2%) 1 (2%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 1 (2%)
Renal Tubule, Atrophy 1 (2%)
Renal Tubule, Dilatation 1 (2%) 1 (2%) 2 (4%)
Renal Tubule, Mineralization 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 1 (2%)
Urinary Bladder (50) (50) (50) (50)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Natural Death 10 3 5 10
Moribund Sacrifice 9 11 9 6
Dosing Accident 1 1
Survivors
Terminal Sacrifice 31 35 35 34
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Necrosis 1 (2%)
Perforation 1 (2%)
Muscularis, Inflammation, Chronic 1 (2%) 1 (2%)
Gallbladder (44) (46) (45) (42)
Inflammation, Chronic 1 (2%)
Intestine Small, Duodenum (46) (48) (48) (46)
Hyperplasia, Adenomatous 1 (2%)
Liver (50) (50) (50) (50)
Basophilic Focus 1 (2%) 1 (2%)
Clear Cell Focus 1 (2%) 6 (12%) 2 (4%) 2 (4%)
Congestion 1 (2%)
Degeneration, Cystic 1 (2%)
Eosinophilic Focus 6 (12%) 7 (14%) 3 (6%) 3 (6%)
Hemorrhage 2 (4%) 1 (2%)
Inflammation, Chronic 45 (90%) 43 (86%) 38 (76%) 41 (82%)
Inflammation, Focal 1 (2%)
Mixed Cell Focus 3 (6%) 3 (6%) 6 (12%) 4 (8%)
Necrosis, Focal 2 (4%) 2 (4%) 3 (6%) 8 (16%)
Pigmentation, Focal 1 (2%)
Vacuolization Cytoplasmic 6 (12%) 7 (14%) 2 (4%) 6 (12%)
Bile Duct, Cyst 1 (2%) 1 (2%) 2 (4%)
Bile Duct, Hyperplasia 29 (58%) 31 (62%) 33 (66%) 29 (58%)
Centrilobular, Necrosis 1 (2%)
Hepatocyte, Karyomegaly 37 (74%) 32 (64%) 31 (62%) 32 (64%)
Mesentery (3) (5) (1) (1)
Inflammation, Chronic 1 (20%)
Thrombosis 1 (20%)
Artery, Inflammation, Chronic 1 (33%) 1 (20%)
Fat, Necrosis 1 (33%) 1 (100%)
Pancreas (48) (50) (50) (50)
Inflammation, Chronic 1 (2%)
Acinus, Atrophy, Diffuse 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Acinus, Atrophy, Focal 2 (4%)
Duct, Cyst 1 (2%) 1 (2%)
Stomach, Forestomach (49) (50) (50) (47)
Cyst 1 (2%) 1 (2%)
Diverticulum 1 (2%)
Edema 1 (2%)
Inflammation, Chronic 1 (2%)
Ulcer 3 (6%)
Epithelium, Hyperplasia 3 (6%) 2 (4%) 5 (10%) 3 (6%)
Stomach, Glandular (49) (50) (50) (47)
Edema 1 (2%)
Erosion 1 (2%)
Hyperplasia, Adenomatous 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%) 1 (2%) 3 (6%) 2 (4%)
Necrosis 1 (2%)
Glands, Degeneration, Cystic, Focal 4 (8%) 4 (8%) 1 (2%)
Tooth (2) (2) (2) (1)
Developmental Malformation 2 (100%) 2 (100%) 1 (50%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (49) (50) (49)
Inflammation, Chronic 1 (2%)
Heart (50) (50) (50) (50)
Inflammation, Chronic, Focal 1 (2%)
Mineralization 2 (4%)
Thrombosis 1 (2%)
Artery, Inflammation, Chronic 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (50) (50) (50)
Cytoplasmic Alteration, Focal 3 (6%) 10 (20%) 6 (12%) 18 (36%)
Hyperplasia, Focal 2 (4%) 7 (14%) 3 (6%)
Hypertrophy, Focal 7 (14%) 11 (22%) 9 (18%) 11 (22%)
Capsule, Hyperplasia, Focal 2 (4%) 2 (4%) 3 (6%) 2 (4%)
Adrenal Medulla (48) (50) (50) (50)
Hyperplasia 1 (2%)
Islets, Pancreatic (48) (50) (50) (50)
Hyperplasia 2 (4%) 1 (2%) 1 (2%)
Parathyroid Gland (50) (45) (48) (46)
Cyst 3 (6%) 1 (2%) 1 (2%)
Pituitary Gland (47) (43) (48) (43)
Pars Distalis, Cyst 1 (2%) 3 (6%) 2 (5%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50) (49)
Degeneration, Cystic, Focal 7 (14%) 11 (22%) 14 (28%) 10 (20%)
Inflammation, Chronic, Focal 1 (2%)
C-Cell, Hyperplasia 1 (2%)
Follicle, Cyst 5 (10%) 5 (10%) 6 (12%) 6 (12%)
Follicular Cell, Hyperplasia 13 (26%) 14 (28%) 7 (14%) 10 (20%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Granuloma Sperm 2 (4%)
Inflammation, Suppurative 1 (2%)
Spermatocele 1 (2%)
Preputial Gland (50) (49) (47) (50)
Degeneration, Cystic 44 (88%) 41 (84%) 42 (89%) 48 (96%)
Inflammation, Chronic 2 (4%) 2 (4%)
Prostate (49) (49) (50) (49)
Inflammation, Chronic 1 (2%)
Seminal Vesicle (50) (50) (50) (49)
Angiectasis 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Testes (50) (50) (50) (50)
Germinal Epithelium, Degeneration 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Hyperplasia 1 (2%) 7 (14%) 1 (2%) 1 (2%)
Lymph Node (2) (4) (5) (2)
Mediastinal, Hyperplasia, Lymphoid 1 (20%)
Mediastinal, Necrosis 1 (20%)
Pancreatic, Hyperplasia, Lymphoid 1 (25%)
Lymph Node, Mandibular (45) (46) (44) (47)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Lymph Node, Mesenteric (46) (50) (50) (50)
Ectasia 3 (6%) 1 (2%) 2 (4%)
Hemorrhage 17 (37%) 21 (42%) 12 (24%) 13 (26%)
Hyperplasia, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 3 (7%) 1 (2%) 1 (2%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Inflammation, Chronic 2 (4%)
Spleen (48) (50) (50) (49)
Angiectasis 1 (2%)
Congestion 3 (6%) 1 (2%) 2 (4%)
Depletion Cellular 2 (4%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 18 (38%) 16 (32%) 12 (24%) 14 (29%)
Hyperplasia, Lymphoid 3 (6%) 3 (6%)
Necrosis, Focal 1 (2%)
Capsule, Fibrosis 1 (2%)
Thymus (42) (45) (46) (42)
Atrophy 3 (7%) 2 (4%) 3 (7%)
Cyst 2 (5%) 6 (13%) 8 (17%) 7 (17%)
Necrosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (49) (50) (50)
Cyst Epithelial Inclusion 2 (4%)
Edema 1 (2%) 1 (2%) 7 (14%) 3 (6%)
Infiltration Cellular, Mast Cell 1 (2%)
Inflammation, Chronic, Focal 1 (2%) 3 (6%) 1 (2%) 2 (4%)
Ulcer 2 (4%)
Subcutaneous Tissue, Edema 1 (2%)
Subcutaneous Tissue, Foreign Body 1 (2%)
Subcutaneous Tissue, Hemorrhage 1 (2%)
Subcutaneous Tissue, Inflammation, Focal,
Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 40 (80%) 26 (52%) 36 (72%) 31 (62%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (49)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 89006-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC AZT/INTERFERON A/INTERFERON AD Date: 08/14/96
Route: GAVAGE Time: 09:06:20
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE 30 MG/KG 60 MG/KG 120MG/KG
CONTROL 5000 U 5000 U 5000 U
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 2 (4%) 1 (2%)
Foreign Body 2 (4%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 4 (8%) 1 (2%) 1 (2%) 2 (4%)
Pigmentation 1 (2%)
Thrombosis 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (4%) 2 (4%) 1 (2%) 3 (6%)
Mediastinum, Inflammation, Chronic 1 (2%)
Nose (50) (50) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Suppurative 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (1) (1)
External Ear, Inflammation, Chronic 1 (100%)
Eye (1) (6) (2)
Cataract 2 (33%) 1 (50%)
Fibrosis 1 (17%)
Cornea, Inflammation, Chronic 1 (100%) 5 (83%) 2 (100%)
Harderian Gland (4) (9) (4) (4)
Hyperplasia, Focal 1 (25%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50) (50) (50)
Cyst 3 (6%) 3 (6%) 2 (4%)
Infarct 1 (2%) 5 (10%) 4 (8%)
Metaplasia, Focal, Osseous 1 (2%)
Nephropathy 49 (100%) 50 (100%) 47 (94%) 44 (88%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Hyperplasia, Focal 2 (4%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 1 (2%)
Urethra (3) (2) (2) (6)
Inflammation, Chronic 1 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
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