TDMS Study 99022-02 Pathology Tables
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
FINAL #2; REVISION #1 MICE
Facility: Southern Research Institute
Chemical CAS #: 30516-87-1
Lock Date: 06/20/02
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Merge 006 006,016
Merge 007 007,017
Merge 008 008,018
Merge 009 009,019
Merge 010 010,020
Merge 001 001,011
Merge 002 002,012
Merge 003 003,013
Merge 004 004,014
Merge 005 005,015
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: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE FEMALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 40 42
Early Deaths
Moribund Sacrifice 16 18 11 11 15
Natural Death 14 13 15 9 8
Accidently Killed 1
Survivors
Moribund Sacrifice 1 1
Terminal Sacrifice 19 17 24 19 18
Natural Death 1 1
Animals Examined Microscopically 50 50 50 40 42
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (49) (49) (39) (42)
Edema 1 [2.0] 1 [2.0] 1 [2.0]
Intestine Large, Cecum (47) (48) (45) (38) (40)
Amyloid Deposition 1 [2.0]
Edema 3 [2.0] 3 [2.7] 4 [2.3] 4 [2.5] 8 [2.3]
Intestine Small, Duodenum (50) (50) (48) (40) (42)
Amyloid Deposition 1 [3.0]
Erosion 1 [2.0] 1 [2.0] 2 [3.0]
Ulcer 2 [3.5] 1 [3.0]
Epithelium, Hyperplasia 12 [2.1] 7 [2.3] 12 [2.4] 4 [2.0] 9 [2.0]
Intestine Small, Jejunum (46) (49) (46) (40) (40)
Amyloid Deposition 1 [3.0]
Epithelium, Hyperplasia 1 [2.0] 1 [2.0] 1 [2.0]
Intestine Small, Ileum (47) (48) (45) (38) (40)
Amyloid Deposition 1 [3.0]
Liver (50) (50) (50) (40) (42)
Amyloid Deposition 1 [3.0] 1 [4.0]
Angiectasis 1 [3.0]
Basophilic Focus 1 1
Cyst 2 1 1
Eosinophilic Focus 1 2 3 1 3
Hematopoietic Cell Proliferation 8 [3.0] 5 [3.4] 5 [2.8] 5 [3.0] 8 [2.5]
Hyperplasia, Lymphoid 3 [2.0]
Infiltration Cellular, Mixed Cell 7 [2.0] 6 [2.5] 6 [2.0] 9 [2.3] 9 [2.1]
Necrosis, Focal 6 [2.2] 8 [2.5] 5 [2.4] 4 [2.3] 6 [2.0]
Regeneration 1 [3.0] 1 [3.0]
Thrombosis 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: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE FEMALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hepatocyte, Hypertrophy 1 [2.0] 6 [2.2] 3 [2.0] 2 [2.5] 2 [2.5]
Hepatocyte, Vacuolization Cytoplasmic 1 [4.0] 3 [2.7] 2 [3.0]
Kupffer Cell, Hyperplasia 1 [3.0] 1 [3.0] 1 [3.0] 2 [2.0]
Kupffer Cell, Pigmentation 4 [2.0] 4 [2.3] 2 [2.5] 6 [2.3] 6 [2.0]
Mesentery (4) (8) (7) (3) (5)
Angiectasis 1 [3.0]
Hemorrhage 1 [4.0] 1 [3.0] 1 [4.0]
Thrombosis 1
Fat, Necrosis 5 [3.4] 4 [3.5] 2 [4.0] 3 [3.7]
Pancreas (50) (49) (49) (40) (41)
Atrophy 1 [2.0] 1 [3.0]
Edema 2 [2.0] 1 [2.0] 1 [2.0]
Necrosis, Focal 1 [3.0]
Acinus, Cytoplasmic Alteration 4 [3.0] 2 [3.0] 4 [3.3]
Salivary Glands (50) (49) (49) (40) (42)
Hyperplasia, Lymphoid 2 [2.5] 6 [2.0] 3 [2.0] 1 [2.0] 4 [2.3]
Stomach, Forestomach (50) (50) (49) (40) (42)
Edema 1 [2.0] 5 [2.2] 3 [2.0] 2 [2.5] 4 [2.3]
Erosion 2 [1.5]
Epithelium, Hyperplasia 4 [1.5] 3 [1.0] 2 [2.0] 4 [1.5]
Stomach, Glandular (50) (50) (49) (40) (42)
Amyloid Deposition 1 [2.0]
Cyst 2
Edema 2 [2.0] 1 [2.0] 2 [2.5]
Erosion 1 [2.0] 2 [2.0] 1 [3.0]
Infiltration Cellular, Mixed Cell 1 [1.0]
Glands, Hyperplasia, Cystic 6 [2.3] 12 [2.3] 8 [2.3] 10 [2.3] 6 [2.5]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (3) (2)
Inflammation, Chronic 1 [2.0]
Heart (50) (49) (50) (40) (42)
Amyloid Deposition 1 [2.0]
Cardiomyopathy 3 [1.7] 2 [1.5] 6 [1.2] 1 [2.0] 2 [1.5]
Inflammation, Chronic 7 [2.0] 1 [3.0] 2 [2.0] 2 [2.5] 2 [2.0]
Mineralization 2 [3.0] 3 [2.0] 2 [1.0] 1 [1.0] 2 [2.5]
Thrombosis 3 1
____________________________________________________________________________________________________________________________________
ENDOCRINE 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 3
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE FEMALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Adrenal Cortex (50) (49) (50) (38) (42)
Accessory Adrenal Cortical Nodule 10 [3.0] 8 [3.0] 11 [3.0] 7 [3.0] 6 [3.0]
Amyloid Deposition 1 [3.0]
Hyperplasia, Diffuse 2 [2.0] 1 [2.0]
Hypertrophy, Focal 1 [3.0]
Capsule, Hyperplasia 1 [2.0] 1 [3.0] 2 [2.0] 2 [2.5]
Adrenal Medulla (50) (49) (50) (38) (42)
Hyperplasia 1 [1.0] 3 [1.0] 1 [1.0]
Islets, Pancreatic (50) (49) (49) (40) (41)
Hyperplasia 2 [1.0] 5 [2.2] 6 [1.8] 7 [1.9] 10 [1.8]
Pituitary Gland (50) (49) (50) (40) (42)
Pars Distalis, Angiectasis 1 [2.0] 1 [2.0] 2 [2.5]
Pars Distalis, Cyst 3 3
Pars Distalis, Hyperplasia, Focal 3 [1.7] 4 [2.0] 1 [3.0] 2 [2.5] 4 [2.0]
Pars Intermedia, Hyperplasia 1 [3.0] 1 [3.0]
Thyroid Gland (50) (49) (50) (40) (42)
Amyloid Deposition 1 [3.0] 1 [2.0]
Degeneration, Cystic 26 [2.1] 18 [2.6] 39 [2.3] 24 [1.7] 29 [2.4]
Follicular Cell, Hyperplasia 4 [1.3] 2 [1.0] 5 [1.4] 4 [1.5] 1 [2.0]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (50) (50) (40) (42)
Cyst 22 18 25 14 12
Infiltration Cellular, Lymphocyte 1 [3.0]
Inflammation, Chronic 23 [2.5] 19 [2.6] 17 [2.6] 14 [2.8] 16 [2.8]
Ovary (50) (50) (49) (40) (42)
Amyloid Deposition 1 [4.0] 1 [3.0]
Angiectasis 1 [2.0] 1 [2.0] 4 [3.8] 3 [3.7] 4 [3.0]
Cyst 38 35 37 28 29
Hematocyst 1
Hemorrhage 2 [2.5] 2 [2.5] 7 [3.1] 5 [2.2] 4 [2.8]
Thrombosis 2 1 1
Bilateral, Cyst 1
Corpus Luteum, Hyperplasia 1 [3.0] 1 [3.0] 1 [3.0] 1 [2.0]
Uterus (50) (50) (49) (40) (42)
Angiectasis 1 [4.0] 4 [3.8] 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 4
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE FEMALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hemorrhage 1 [2.0] 1 [2.0]
Infiltration Cellular, Histiocyte 1 [3.0]
Inflammation, Chronic 1 [3.0] 1 [2.0] 1 [3.0]
Thrombosis 2 3 1
Endometrium, Hyperplasia, Cystic 22 [2.2] 27 [2.5] 29 [2.7] 24 [2.7] 22 [2.6]
Vagina (49) (49) (47) (40) (41)
Cyst 2 1
Epithelium, Hyperplasia 1 [3.0] 1 [2.0] 2 [2.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (40) (42)
Hyperplasia 33 [3.0] 24 [3.1] 30 [2.9] 22 [2.6] 26 [2.8]
Myelofibrosis 1 [3.0] 1 [3.0]
Lymph Node (14) (23) (16) (12) (16)
Hematopoietic Cell Proliferation 1 [3.0] 1 [4.0] 2 [2.5]
Hemorrhage 1 [3.0]
Hyperplasia, Lymphoid 1 [4.0] 3 [4.0] 1 [3.0]
Hyperplasia, Plasma Cell 2 [3.5] 1 [4.0]
Pigmentation 1 [2.0]
Bronchial, Hemorrhage 1 [3.0]
Iliac, Hematopoietic Cell Proliferation 1 [4.0] 1 [3.0] 1 [3.0]
Iliac, Hemorrhage 1 [3.0]
Iliac, Hyperplasia, Lymphoid 2 [4.0] 2 [3.5]
Inguinal, Hematopoietic Cell Proliferation 1 [3.0] 1 [2.0]
Inguinal, Hyperplasia, Lymphoid 2 [3.0] 4 [3.5] 2 [3.0] 1 [2.0] 2 [3.5]
Inguinal, Hyperplasia, Plasma Cell 1 [3.0]
Inguinal, Pigmentation 1 [1.0]
Lumbar, Hematopoietic Cell Proliferation 1 [3.0]
Lumbar, Hyperplasia, Lymphoid 1 [4.0] 1 [3.0]
Mediastinal, Hematopoietic Cell Proliferation 1 [3.0]
Mediastinal, Hemorrhage 1 [4.0] 1 [2.0] 2 [3.5] 1 [3.0]
Mediastinal, Hyperplasia, Lymphoid 1 [3.0] 2 [2.0] 1 [4.0]
Mediastinal, Pigmentation 1 [2.0]
Pancreatic, Hyperplasia, Lymphoid 1 [3.0]
Popliteal, Hyperplasia 1 [4.0]
Popliteal, Hyperplasia, Lymphoid 1 [3.0]
Renal, Ectasia 1 [3.0]
Renal, Hematopoietic Cell Proliferation 1 [2.0]
Renal, Hemorrhage 2 [2.5] 1 [2.0]
Renal, Hyperplasia, Lymphoid 3 [3.7] 2 [2.5]
Lymph Node, Mandibular (49) (47) (49) (40) (42)
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: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE FEMALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Amyloid Deposition 1 [3.0]
Atrophy 2 [2.5] 2 [3.0] 1 [2.0] 4 [2.5]
Ectasia 2 [4.0] 1 [4.0] 3 [3.0] 2 [4.0]
Hematopoietic Cell Proliferation 7 [2.1] 3 [3.0] 2 [1.5] 4 [2.0] 6 [1.8]
Hemorrhage 3 [3.3] 4 [1.8] 5 [2.6] 5 [2.0] 7 [2.1]
Hyperplasia, Lymphoid 9 [3.1] 10 [2.8] 17 [2.4] 10 [2.6] 4 [2.0]
Hyperplasia, Plasma Cell 5 [3.2] 3 [3.7]
Infiltration Cellular, Plasma Cell 2 [3.0]
Pigmentation 5 [2.0] 4 [2.3] 2 [2.0] 4 [2.3] 6 [2.0]
Lymph Node, Mesenteric (50) (48) (46) (40) (42)
Atrophy 2 [3.0] 4 [2.8] 2 [2.5] 1 [3.0] 5 [2.4]
Ectasia 2 [2.0] 3 [2.3] 2 [2.5] 3 [3.3] 1 [3.0]
Hematopoietic Cell Proliferation 6 [2.7] 6 [2.2] 2 [2.5] 3 [2.7] 8 [2.3]
Hemorrhage 12 [2.5] 10 [2.1] 9 [2.8] 9 [2.3] 11 [2.3]
Hyperplasia, Lymphoid 6 [1.7] 7 [2.4] 9 [2.7] 10 [2.4] 7 [2.6]
Pigmentation 2 [2.0] 7 [2.0] 3 [2.0] 2 [2.0] 4 [2.0]
Spleen (50) (50) (49) (40) (42)
Amyloid Deposition 1 [3.0]
Hematopoietic Cell Proliferation 31 [2.8] 21 [2.8] 32 [2.3] 26 [2.6] 29 [3.0]
Pigmentation 13 [2.5] 24 [2.4] 12 [2.3] 10 [2.0] 12 [2.3]
Lymphoid Follicle, Atrophy 4 [3.3] 6 [2.5] 5 [2.8] 6 [2.7] 4 [2.8]
Lymphoid Follicle, Hyperplasia 7 [2.4] 3 [2.0] 7 [2.1] 6 [2.5] 7 [2.1]
Thymus (49) (44) (46) (36) (42)
Atrophy 7 [2.6] 3 [2.0] 5 [2.8] 2 [2.5] 4 [2.8]
Hemorrhage 1 [3.0] 4 [3.0] 2 [2.5] 3 [3.0]
Hyperplasia, Lymphoid 7 [2.7] 3 [3.3] 3 [3.0] 7 [2.7] 2 [3.0]
Thrombosis 1
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (49) (40) (42)
Hyperplasia 9 [2.1] 9 [2.4] 8 [2.0] 6 [2.2] 7 [1.9]
Skin (50) (50) (49) (40) (42)
Cyst Epithelial Inclusion 1 2
Edema 3 [3.0] 7 [3.0] 7 [2.9] 6 [2.7] 5 [3.2]
Inflammation, Chronic 1 [2.0] 1 [2.0] 1 [2.0] 1 [4.0]
Ulcer 8 [3.9] 5 [4.0] 1 [4.0] 5 [3.0] 3 [3.7]
Epidermis, Hyperplasia 7 [3.4] 5 [3.8] 3 [2.7] 4 [2.5] 3 [4.0]
____________________________________________________________________________________________________________________________________
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: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE FEMALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM - CONT
Bone (50) (50) (50) (40) (42)
Fibrous Osteodystrophy 2 [2.5] 7 [2.3] 9 [2.3] 6 [2.3] 4 [2.5]
Hyperostosis 1 [2.0] 1 [3.0]
Myelofibrosis 1 [3.0]
Cranium, Hyperostosis 1 [3.0]
Femur, Callus 1
Femur, Hyperostosis 1 [4.0]
Skeletal Muscle (5) (2) (1) (1) (4)
Inflammation, Chronic 1 [3.0] 1 [4.0]
Thrombosis 1
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (40) (42)
Compression 1 [4.0]
Hemorrhage 1 [3.0] 1 [1.0]
Necrosis 1 [3.0]
Peripheral Nerve (7) (5) (3) (5) (6)
Atrophy 1 [2.0] 1 [2.0] 1 [2.0]
Spinal Cord (50) (50) (50) (40) (42)
Cyst Epithelial Inclusion 1 1 1
Necrosis 1 [3.0] 1 [2.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49) (50) (40) (42)
Amyloid Deposition 1 [3.0]
Edema 1 [2.0] 3 [3.3] 4 [2.8] 1 [3.0] 3 [2.7]
Fibrosis, Focal 1 [2.0]
Foreign Body 3
Hemorrhage 7 [1.6] 6 [2.7] 6 [1.5] 2 [2.0] 8 [2.1]
Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 3 [2.7] 4 [2.8] 1 [2.0]
Infiltration Cellular, Histiocyte 12 [2.3] 11 [3.0] 21 [2.9] 12 [3.4] 10 [2.8]
Infiltration Cellular, Mixed Cell 2 [2.5] 1 [2.0] 1 [3.0]
Inflammation, Chronic 1 [2.0] 2 [2.5] 2 [3.5]
Alveolar Epithelium, Hyperplasia 2 [1.5] 2 [2.0] 10 [2.0] 3 [2.7] 2 [2.0]
Nose (50) (50) (50) (40) (42)
Foreign Body 2
Inflammation, Chronic 11 [1.6] 2 [1.5] 7 [2.0] 2 [1.0] 4 [1.8]
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 7
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE FEMALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (1) (2)
Atrophy 1 [4.0] 1 [3.0]
Cataract 1 [3.0]
Inflammation, Chronic 1 [3.0]
Harderian Gland (49) (49) (50) (40) (41)
Atrophy 1 [3.0] 1 [3.0]
Hyperplasia, Focal 1 [2.0] 2 [2.5] 1 [2.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (40) (42)
Amyloid Deposition 2 [3.5] 1 [3.0] 2 [3.0]
Cyst 2 7 5 7 5
Hydronephrosis 2 [1.5] 7 [2.6] 5 [2.6] 5 [2.8] 3 [2.3]
Infarct 1 [2.0] 3 [3.3] 2 [3.0]
Infiltration Cellular, Mixed Cell 10 [2.1] 20 [2.4] 15 [2.3] 14 [2.5] 15 [2.1]
Inflammation, Chronic 3 [3.0]
Metaplasia, Osseous 1 [1.0] 2 [2.0]
Nephropathy 29 [2.0] 31 [2.6] 41 [2.2] 26 [2.2] 33 [2.2]
Renal Tubule, Accumulation, Hyaline Droplet 1 [4.0] 2 [3.5] 2 [3.0] 3 [3.3] 3 [2.7]
Renal Tubule, Dilatation 1 [3.0] 3 [3.0] 1 [2.0]
Renal Tubule, Necrosis 1 [2.0] 1 [2.0]
Renal Tubule, Pigmentation 1 [3.0] 1 [3.0] 1 [2.0] 2 [2.5] 2 [3.0]
Urinary Bladder (50) (50) (49) (40) (42)
Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 3 [2.3] 2 [2.5] 3 [2.3]
Inflammation, Chronic 1 [2.0] 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 8
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE MALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 37 32
Early Deaths
Moribund Sacrifice 24 20 25 23 12
Natural Death 7 9 11 5 10
Accidently Killed 1 1 2
Survivors
Terminal Sacrifice 19 20 13 7 7
Moribund Sacrifice 1
Natural Death 1
Other 1
Animals Examined Microscopically 50 50 50 37 32
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (48) (50) (49) (37) (32)
Edema 2 [2.0] 1 [2.0]
Intestine Large, Cecum (49) (49) (48) (35) (30)
Edema 13 [2.0] 11 [2.2] 8 [2.3] 14 [2.1] 2 [2.0]
Infiltration Cellular, Lymphocyte 1 [4.0]
Intestine Small, Duodenum (49) (50) (49) (36) (32)
Amyloid Deposition 1 [2.0]
Epithelium, Hyperplasia 3 [2.3] 4 [2.0] 4 [2.5] 1 [2.0] 1 [2.0]
Intestine Small, Jejunum (49) (50) (46) (36) (29)
Amyloid Deposition 1 [2.0]
Epithelium, Hyperplasia 4 [2.3] 2 [2.5] 1 [3.0] 1 [2.0]
Intestine Small, Ileum (49) (48) (47) (35) (30)
Amyloid Deposition 1 [3.0]
Liver (50) (50) (50) (37) (32)
Amyloid Deposition 1 [2.0]
Angiectasis 1 [2.0] 1 [2.0] 1 [2.0]
Basophilic Focus 2 4 2 2
Cholangiofibrosis 1 [4.0]
Clear Cell Focus 1 1
Cyst 2 1
Eosinophilic Focus 3 2 2 1 2
Hematopoietic Cell Proliferation 9 [1.9] 7 [2.6] 12 [2.7] 6 [3.2] 5 [2.4]
Hemorrhage 1 [4.0] 1 [3.0] 1 [3.0]
Hyperplasia, Lymphoid 1 [2.0]
Infarct 1 [2.0]
Infiltration Cellular, Mixed Cell 10 [2.0] 7 [2.1] 2 [2.0] 5 [2.6] 2 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 9
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE MALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Necrosis, Focal 8 [2.5] 9 [2.7] 7 [3.0] 4 [2.5] 3 [2.0]
Regeneration 1 1
Tension Lipidosis 1 1
Centrilobular, Necrosis 2 [2.0] 1 [2.0]
Hepatocyte, Hypertrophy 15 [2.1] 15 [2.5] 9 [2.3] 6 [2.5] 15 [2.3]
Hepatocyte, Vacuolization Cytoplasmic 1 [2.0] 1 [2.0] 2 [3.0] 1 [2.0]
Hepatocyte, Centrilobular, Vacuolization
Cytoplasmic 1 [3.0]
Kupffer Cell, Hyperplasia 2 [3.0] 1 [3.0] 1 [3.0]
Kupffer Cell, Pigmentation 2 [2.0] 3 [2.7] 2 [2.0] 3 [2.3]
Mesentery (1) (2) (3) (1)
Hemorrhage 1 [4.0] 1 [3.0]
Fat, Necrosis 1 [2.0] 3 [2.7]
Pancreas (50) (50) (50) (37) (31)
Atrophy 1 [4.0]
Cyst 1
Edema 1 [3.0] 2 [2.0] 2 [3.0]
Infiltration Cellular, Mixed Cell 1 [2.0]
Acinus, Cytoplasmic Alteration 1 [3.0] 2 [3.5] 1 [3.0] 1 [4.0] 1 [3.0]
Salivary Glands (50) (50) (50) (37) (32)
Atrophy 1 [3.0] 1 [2.0]
Hyperplasia, Lymphoid 1 [2.0]
Infiltration Cellular, Lymphoid 1 [2.0] 5 [1.8]
Infiltration Cellular, Mixed Cell 1 [2.0] 1 [2.0] 2 [1.5]
Stomach, Forestomach (49) (50) (50) (37) (32)
Diverticulum 1
Edema 1 [2.0] 2 [2.0] 1 [2.0]
Ulcer 1 [2.0]
Epithelium, Hyperplasia 2 [1.0] 1 [3.0] 1 [2.0] 1 [1.0]
Stomach, Glandular (49) (50) (50) (37) (32)
Edema 1 [2.0] 2 [2.0] 2 [2.0]
Erosion 2 [2.5] 2 [2.0] 1 [3.0] 1 [2.0]
Glands, Hyperplasia, Cystic 9 [2.2] 13 [2.1] 10 [2.5] 15 [2.5] 6 [2.3]
Tooth (1)
Malformation 1
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1) (1) (1)
Inflammation, Chronic 1 [4.0]
Heart (50) (50) (50) (37) (32)
Amyloid Deposition 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 10
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE MALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Cardiomyopathy 12 [1.9] 7 [2.0] 19 [1.6] 13 [1.7] 7 [1.7]
Inflammation 1 [2.0]
Inflammation, Chronic 1 [1.0] 5 [2.6] 3 [2.3] 2 [2.5] 1 [1.0]
Mineralization 2 [2.5] 1 [1.0] 1 [2.0]
Thrombosis 2 4 5 3 3
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (37) (32)
Accessory Adrenal Cortical Nodule 8 [3.0] 9 [3.0] 7 [3.0] 6 [3.0] 6 [3.0]
Amyloid Deposition 1 [2.0]
Hyperplasia, Focal 2 [2.5] 5 [2.0] 3 [2.0] 2 [2.0]
Hypertrophy, Focal 6 [2.5] 5 [3.0] 4 [2.3] 4 [2.3] 4 [2.0]
Capsule, Hyperplasia 2 [2.5] 2 [3.0] 1 [3.0] 3 [2.3] 2 [2.0]
Adrenal Medulla (50) (50) (49) (37) (32)
Hyperplasia 2 [2.0] 1 [1.0] 1 [3.0]
Islets, Pancreatic (50) (50) (50) (36) (31)
Hyperplasia 15 [1.9] 13 [2.1] 12 [2.2] 6 [2.0] 6 [2.0]
Pituitary Gland (48) (49) (49) (36) (31)
Pars Distalis, Cyst 1 2 3 2 1
Thyroid Gland (50) (50) (50) (37) (32)
Amyloid Deposition 1 [2.0]
Degeneration, Cystic 29 [2.3] 23 [2.0] 33 [2.3] 15 [2.1] 15 [2.2]
Follicular Cell, Hyperplasia 3 [1.0] 2 [1.5]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (2) (2) (1) (1)
Bilateral, Dilatation 1 [4.0]
Epididymis (50) (50) (50) (37) (32)
Atypia Cellular 1 [3.0] 3 [2.3] 3 [2.3] 3 [2.0] 3 [2.3]
Granuloma Sperm 1 [3.0]
Inflammation, Chronic 1 [2.0] 1 [3.0]
Spermatocele 2 [2.5] 1 [3.0]
Penis (2) (1) (3) (1)
Inflammation, Chronic Active 2 [2.5] 1 [2.0] 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 11
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE MALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Preputial Gland (50) (50) (50) (37) (32)
Cyst 6 7 6 6 2
Inflammation, Chronic 11 [2.6] 11 [2.6] 18 [3.1] 8 [2.6] 9 [2.6]
Prostate (50) (50) (50) (37) (32)
Inflammation, Chronic 8 [2.6] 3 [2.7] 12 [2.1] 6 [2.8] 5 [2.8]
Seminal Vesicle (50) (50) (50) (37) (32)
Degeneration 1 [3.0] 1 [3.0] 1 [3.0]
Dilatation 2 [3.0] 3 [3.0]
Inflammation, Chronic 2 [3.0] 3 [2.7] 3 [3.0]
Testes (50) (50) (50) (37) (32)
Germinal Epithelium, Atrophy 4 [2.0] 7 [2.1] 5 [2.4] 3 [1.7] 4 [2.5]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (37) (32)
Hyperplasia 43 [3.2] 29 [3.1] 35 [3.1] 27 [3.0] 24 [2.9]
Infiltration Cellular, Mast Cell 1 [3.0]
Myelofibrosis 1 [3.0]
Lymph Node (12) (10) (15) (6) (2)
Hematopoietic Cell Proliferation 3 [2.7] 2 [2.5] 1 [3.0]
Hyperplasia, Lymphoid 1 [2.0] 3 [3.7] 2 [3.0] 2 [4.0]
Hyperplasia, Plasma Cell 3 [3.3] 2 [3.5]
Bronchial, Hyperplasia, Lymphoid 1 [3.0]
Iliac, Hyperplasia, Lymphoid 1 [4.0] 1 [4.0]
Iliac, Pigmentation 1 [3.0]
Inguinal, Hematopoietic Cell Proliferation 1 [2.0] 1 [3.0] 1 [3.0]
Inguinal, Hyperplasia, Lymphoid 2 [2.0] 1 [3.0] 6 [3.5] 1 [3.0]
Inguinal, Hyperplasia, Plasma Cell 2 [3.0]
Inguinal, Pigmentation 1 [2.0]
Lumbar, Pigmentation 1 [2.0]
Mediastinal, Hemorrhage 1 [2.0]
Mediastinal, Hyperplasia, Lymphoid 3 [3.3]
Renal, Hyperplasia, Lymphoid 1 [3.0] 1 [4.0]
Renal, Hyperplasia, Plasma Cell 1 [3.0]
Lymph Node, Mandibular (50) (50) (49) (37) (32)
Atrophy 1 [2.0] 3 [2.7]
Ectasia 2 [3.5] 1 [3.0] 1 [4.0] 2 [3.5]
Hematopoietic Cell Proliferation 7 [2.1] 6 [2.5] 4 [2.5] 5 [2.2]
Hemorrhage 3 [1.7]
Hyperplasia, Lymphoid 11 [2.2] 7 [3.0] 9 [2.7] 6 [2.5] 9 [2.8]
Hyperplasia, Plasma Cell 11 [2.9] 9 [3.0] 6 [2.8] 3 [2.3] 4 [2.5]
Pigmentation 1 [2.0] 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 12
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE MALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymph Node, Mesenteric (50) (49) (49) (36) (32)
Atrophy 1 [2.0] 2 [3.0] 3 [2.7]
Ectasia 2 [3.0] 7 [2.9] 3 [2.3] 6 [2.7] 2 [2.5]
Hematopoietic Cell Proliferation 12 [2.4] 3 [2.7] 8 [2.6] 3 [2.3] 4 [2.3]
Hemorrhage 7 [2.3] 14 [1.9] 17 [2.5] 8 [2.4] 9 [2.1]
Hyperplasia, Lymphoid 15 [2.2] 16 [2.6] 9 [2.2] 10 [2.6] 6 [2.5]
Infiltration Cellular, Histiocyte 1 [2.0]
Necrosis 1 [3.0] 1 [2.0] 3 [2.7]
Pigmentation 1 [2.0] 1 [2.0] 1 [2.0] 1 [2.0]
Spleen (49) (50) (50) (37) (32)
Hematopoietic Cell Proliferation 31 [3.4] 29 [3.0] 27 [3.0] 18 [3.1] 20 [2.7]
Pigmentation 2 [2.0] 3 [2.0] 4 [2.0] 2 [2.5]
Lymphoid Follicle, Atrophy 4 [3.3] 5 [2.6] 5 [2.6] 7 [2.9] 2 [3.0]
Lymphoid Follicle, Hyperplasia 6 [2.0] 5 [2.4] 2 [2.5] 1 [2.0]
Thymus (48) (45) (47) (33) (32)
Atrophy 15 [2.6] 12 [2.9] 15 [2.7] 13 [2.8] 7 [2.6]
Cyst 2 1 2 1 1
Hyperplasia, Lymphoid 1 [2.0] 1 [2.0] 6 [2.7] 1 [4.0] 6 [2.2]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50) (50) (37) (32)
Cyst Epithelial Inclusion 2 1
Edema 10 [2.9] 2 [3.0] 7 [2.4] 7 [3.0] 1 [2.0]
Ulcer 14 [3.9] 14 [3.6] 13 [3.8] 7 [4.0] 6 [4.0]
Epidermis, Hyperplasia 13 [3.5] 12 [3.1] 12 [3.4] 8 [3.3] 5 [3.6]
Epidermis, Inflammation 1 [3.0] 1 [4.0]
Epidermis, Ulcer 1 [4.0]
Subcutaneous Tissue, Edema 1 [4.0] 1 [3.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (37) (32)
Fibrous Osteodystrophy 1 [2.0] 1 [2.0] 1 [2.0]
Fracture 1
Femur, Osteopetrosis 1 [3.0] 2 [3.0]
Scapula, Osteopetrosis 1 [3.0]
Skeletal Muscle (1) (2) (1) (3) (2)
Hemorrhage 1 [3.0]
Pigmentation 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 13
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE MALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (50) (50) (37) (32)
Hydrocephalus 1 [4.0]
Necrosis 1 [2.0]
Spinal Cord (50) (50) (50) (37) (32)
Cyst Epithelial Inclusion 1 1
Demyelination 1 [3.0]
Infiltration Cellular, Mast Cell 1 [3.0]
Necrosis 1 [2.0] 1 [1.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (37) (32)
Congestion 1 [3.0]
Edema 1 [3.0] 2 [3.0] 4 [2.5]
Fibrosis, Focal 1 [3.0]
Foreign Body 1 1 1 1
Hemorrhage 5 [1.6] 3 [2.0] 7 [2.4] 5 [1.6] 2 [2.5]
Hyperplasia, Lymphoid 1 [3.0] 1 [1.0] 1 [3.0]
Infiltration Cellular, Histiocyte 12 [2.3] 16 [2.9] 13 [2.8] 16 [3.2] 14 [3.0]
Inflammation, Chronic 2 [2.5] 1 [3.0] 5 [3.0] 2 [2.5] 1 [3.0]
Thrombosis 1 1
Alveolar Epithelium, Hyperplasia 6 [1.5] 3 [2.3] 1 [1.0] 4 [2.8]
Nose (50) (50) (50) (36) (32)
Foreign Body 1 1 1
Inflammation, Chronic 5 [2.2] 5 [2.0] 5 [1.8] 3 [1.7] 4 [1.8]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (50) (50) (49) (37) (32)
Hyperplasia, Focal 2 [2.5] 1 [2.0] 1 [3.0] 1 [2.0]
Hypertrophy, Focal 1 [1.0]
Inflammation 1 [2.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (37) (32)
Amyloid Deposition 3 [2.7]
Cyst 27 23 26 24 17
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 14
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: PERINATAL EXPOS WITH AVERAGE SEVERITY GRADES[b] Date: 09/09/04
Route: IN-UTERO AZT TRANSPLACENTAL CARCINOGENESIS STUDY Time: 14:01:53
____________________________________________________________________________________________________________________________________
SWISS MICE MALE 0 50 100 200 300
MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Hydronephrosis 30 [2.1] 20 [3.0] 17 [2.8] 16 [2.9] 14 [2.3]
Infarct 1 [2.0] 1 [4.0] 1 [2.0]
Infiltration Cellular, Mixed Cell 9 [2.0] 11 [2.1] 17 [2.4] 9 [2.7] 12 [2.3]
Inflammation, Chronic 1 [2.0] 2 [2.0] 1 [3.0] 2 [2.0]
Inflammation, Suppurative 4 [3.5]
Metaplasia, Osseous 1 [2.0] 1 [2.0] 1 [1.0]
Mineralization 1 [3.0] 1 [3.0]
Nephropathy 40 [1.8] 40 [1.8] 42 [1.9] 30 [2.1] 23 [2.0]
Renal Tubule, Dilatation 1 [2.0] 5 [2.4] 2 [2.5] 1 [2.0]
Renal Tubule, Necrosis 3 [1.3] 1 [4.0]
Renal Tubule, Pigmentation 1 [2.0] 2 [3.0] 2 [2.0]
Ureter (3) (1) (1)
Dilatation 2 [2.5] 1 [2.0] 1 [1.0]
Urethra (1) (4) (5) (3) (3)
Angiectasis 1 [4.0] 3 [4.0] 1 [4.0] 1 [4.0]
Inflammation, Chronic 1 [3.0] 1 [3.0] 3 [3.0] 1 [3.0]
Bulbourethral Gland, Cyst 1 2 1 2
Urinary Bladder (50) (50) (50) (37) (32)
Edema 1 [3.0] 2 [3.0]
Hemorrhage 3 [2.3] 2 [3.5] 2 [2.0]
Inflammation, Chronic 4 [2.5] 2 [2.5] 1 [2.0] 1 [3.0]
Transitional Epithelium, Hyperplasia 4 [2.5] 1 [2.0] 3 [2.0] 1 [2.0] 1 [2.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 15
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