TDMS Study 05075-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
DIPHENYLHYDANTOIN
NTP Experiment-Test: 05075-02 Report: PEIRPT03
Study Type: CHRONIC Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
Facility: Battelle Columbus Laboratory
Chemical CAS #: 57-41-0
Lock Date: None
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: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50 50 50
Early Deaths
Natural Death 6 5 6 7 6 4
Moribund Sacrifice 8 11 9 6 6 8
Survivors
Terminal Sacrifice 36 34 35 37 38 38
Animals Examined Microscopically 50 50 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (46) (15) (20) (13) (10) (11)
Fibrosis 1 (9%)
Parasite Metazoan 1 (10%)
Intestine Small, Duodenum (47) (14) (14) (12) (10) (10)
Inflammation, Acute, Necrotizing 1 (7%) 1 (10%) 2 (20%)
Intestine Small, Ileum (46) (15) (14) (14) (11) (11)
Inflammation, Acute, Necrotizing 1 (9%)
Intestine Small, Jejunum (48) (16) (14) (15) (12) (11)
Hyperplasia, Lymphoid 1 (2%)
Liver (48) (49) (50) (50) (50) (49)
Basophilic Focus 1 (2%) 2 (4%) 3 (6%) 2 (4%) 1 (2%)
Clear Cell Focus 1 (2%) 1 (2%)
Degeneration, Cystic 1 (2%) 1 (2%)
Eosinophilic Focus 1 (2%) 3 (6%) 5 (10%) 4 (8%) 3 (6%)
Fatty Change 2 (4%) 6 (12%) 26 (52%) 27 (54%) 23 (47%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Infarct, Multifocal 6 (13%) 5 (10%) 3 (6%) 2 (4%) 2 (4%) 3 (6%)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic 5 (10%) 1 (2%)
Mixed Cell Focus 1 (2%)
Necrosis, Focal 1 (2%)
Regeneration, Diffuse 1 (2%)
Bile Duct, Hyperplasia 1 (2%)
Centrilobular, Congestion, Chronic 1 (2%)
Centrilobular, Cytomegaly 3 (6%) 26 (52%) 25 (50%) 25 (51%)
Hepatocyte, Necrosis 1 (2%) 1 (2%)
Mesentery (8) (2) (5) (4) (4) (2)
Inflammation, Suppurative 1 (20%) 1 (25%) 1 (25%)
Artery, Inflammation, Chronic Active 1 (20%) 1 (25%)
Fat, Necrosis 1 (13%) 2 (40%) 1 (25%) 1 (25%)
Pancreas (47) (15) (15) (12) (12) (11)
Inflammation, Chronic 1 (7%) 1 (9%)
Acinus, Atrophy 6 (13%) 2 (13%) 2 (17%) 2 (18%)
Acinus, Focal Cellular Change 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Duct, Dilatation 1 (2%) 1 (7%) 1 (8%)
Duct, Hyperplasia 1 (9%)
Salivary Glands (49) (15) (14) (14) (12) (11)
Necrosis 1 (7%)
Stomach, Forestomach (48) (20) (20) (20) (12) (16)
Cyst 1 (5%) 1 (8%)
Hyperplasia, Squamous 4 (20%) 3 (19%)
Epithelium, Hyperplasia 2 (10%) 2 (10%) 2 (13%)
Stomach, Glandular (48) (16) (16) (15) (11) (13)
Cyst 1 (6%)
Artery, Inflammation, Chronic Active 1 (7%)
Tooth (5) (1) (1)
Incisor, Upper, Dysplasia 3 (60%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (16) (15) (13) (12) (13)
Bacterium 1 (8%) 1 (8%)
Cardiomyopathy, Chronic Active 2 (4%) 1 (8%)
Mineralization 1 (6%)
Artery, Inflammation, Chronic Active 2 (13%) 2 (15%)
Atrium, Thrombosis 1 (8%)
Valve, Inflammation, Suppurative 1 (8%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (48) (16) (14) (13) (12) (11)
Hematopoietic Cell Proliferation 1 (8%)
Hypertrophy 3 (6%)
Necrosis 1 (2%)
Corticomedullary Junction, Degeneration,
Fatty 5 (10%) 1 (8%)
Adrenal Gland, Medulla (48) (16) (14) (13) (12) (11)
Hyperplasia 1 (2%) 1 (6%) 1 (9%)
Pituitary Gland (44) (19) (17) (17) (14) (15)
Pars Distalis, Hyperplasia 19 (43%) 1 (6%) 2 (12%) 1 (7%) 2 (13%)
Thyroid Gland (47) (16) (15) (14) (12) (11)
Inflammation, Chronic Active 3 (6%)
Follicular Cell, Hyperplasia 4 (9%) 1 (6%) 1 (7%) 1 (8%) 2 (18%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (1) (1)
Duct, Dilatation 1 (100%) 1 (100%)
Ovary (49) (28) (36) (28) (25) (30)
Angiectasis 1 (2%) 1 (4%) 1 (3%)
Cyst 25 (51%) 17 (61%) 29 (81%) 16 (57%) 15 (60%) 24 (80%)
Fibrosis 1 (3%)
Inflammation, Chronic Active 6 (21%) 2 (8%) 1 (3%)
Mineralization 1 (2%)
Thrombosis 2 (4%) 1 (3%) 1 (4%) 1 (3%)
Uterus (49) (36) (31) (33) (33) (32)
Dilatation 2 (6%) 1 (3%) 1 (3%) 2 (6%)
Fibrosis 1 (3%)
Inflammation, Chronic Active 2 (6%)
Inflammation, Suppurative 1 (2%) 2 (6%) 2 (6%) 3 (9%) 1 (3%)
Thrombosis 1 (3%)
Endometrium, Hyperplasia, Cystic 15 (31%) 18 (50%) 16 (52%) 20 (61%) 24 (73%) 25 (78%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (48) (16) (15) (13) (12) (11)
Myelofibrosis 1 (2%)
Femoral, Myelofibrosis 2 (4%) 1 (9%)
Lymph Node (50) (18) (16) (20) (15) (20)
Lumbar, Edema 1 (5%)
Mandibular, Edema 1 (5%) 1 (5%)
Mandibular, Hyperplasia, Lymphoid 1 (5%)
Mediastinal, Inflammation, Suppurative 2 (13%)
Pancreatic, Hyperplasia, Lymphoid 1 (5%)
Lymph Node, Mesenteric (12) (7) (5) (6) (4) (9)
Angiectasis 3 (25%) 2 (29%) 1 (20%) 1 (11%)
Necrosis 1 (14%)
Spleen (48) (23) (27) (23) (23) (27)
Hematopoietic Cell Proliferation 6 (13%) 1 (4%) 5 (19%) 4 (17%) 6 (26%) 3 (11%)
Hyperplasia, Lymphoid 2 (9%) 3 (11%) 3 (13%) 2 (7%)
Necrosis 1 (4%)
Thymus (42) (12) (11) (9) (11) (10)
Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (15) (12) (13) (9) (5)
Hyperplasia, Cystic 1 (2%)
Skin (49) (16) (17) (13) (12) (13)
Inflammation, Chronic Active 1 (2%) 1 (8%)
Subcutaneous Tissue, Fibrosis 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (16) (15) (13) (13) (12)
Compression 1 (2%) 1 (6%)
Hemorrhage 2 (4%)
Necrosis 1 (2%) 1 (7%)
Artery, Inflammation, Chronic Active 1 (7%)
Meninges, Infiltration Cellular, Lymphocyte 1 (8%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (20) (20) (15) (13) (13)
Bacterium 1 (8%)
Hemorrhage, Chronic 1 (7%)
Hyperplasia, Lymphoid 1 (8%)
Inflammation, Acute 1 (8%)
Inflammation, Chronic Active 3 (6%) 2 (10%) 3 (20%) 2 (15%)
Alveolar Epithelium, Hyperplasia 4 (8%) 1 (5%)
Nose (50) (16) (15) (13) (12) (12)
Mucosa, Inflammation, Suppurative 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (7%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (2) (1) (2) (1) (3)
Degeneration 2 (100%) 2 (100%) 1 (100%) 3 (100%)
Cornea, Inflammation, Chronic Active 2 (100%)
Harderian Gland (8) (4) (4) (3) (4) (4)
Hyperplasia 3 (38%) 1 (25%) 1 (33%)
Inflammation, Chronic Active 1 (13%)
Zymbal's Gland (1)
Dilatation 1 (100%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 0 PPM 60 PPM 200 PPM 200 PPM 200 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (48) (16) (16) (13) (14) (12)
Cyst 2 (13%)
Nephropathy, Chronic 14 (29%) 4 (25%) 4 (31%) 1 (7%) 1 (8%)
Artery, Inflammation, Chronic Active 1 (8%)
Glomerulus, Inflammation,
Membranoproliferative 1 (2%) 1 (6%) 1 (8%)
Pelvis, Inflammation, Suppurative 1 (8%)
Renal Tubule, Necrosis 1 (2%) 1 (6%) 1 (8%)
Renal Tubule, Regeneration 1 (6%)
Urinary Bladder (48) (15) (15) (13) (11) (11)
Artery, Inflammation, Chronic Active 1 (8%) 1 (9%) 1 (9%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 600 PPM 600 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50
Early Deaths
Natural Death 4 5
Moribund Sacrifice 6 8
Survivors
Terminal Sacrifice 40 37
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (49) (48)
Parasite Metazoan 1 (2%)
Intestine Small, Jejunum (48) (48)
Edema 1 (2%)
Inflammation, Acute, Necrotizing 1 (2%) 1 (2%)
Liver (50) (50)
Basophilic Focus 3 (6%) 4 (8%)
Clear Cell Focus 5 (10%) 1 (2%)
Degeneration, Cystic 5 (10%)
Eosinophilic Focus 8 (16%) 8 (16%)
Fibrosis, Multifocal 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Infarct, Multifocal 6 (12%) 11 (22%)
Inflammation, Chronic 2 (4%)
Mixed Cell Focus 2 (4%)
Vacuolization Cytoplasmic 1 (2%)
Centrilobular, Cytomegaly 37 (74%) 31 (62%)
Mesentery (6) (6)
Artery, Inflammation, Chronic Active 1 (17%)
Pancreas (49) (48)
Inflammation, Chronic 1 (2%)
Acinus, Atrophy 5 (10%) 3 (6%)
Acinus, Depletion Secretory 1 (2%) 1 (2%)
Artery, Inflammation, Chronic Active 2 (4%)
Stomach, Forestomach (49) (48)
Diverticulum 1 (2%)
Inflammation, Chronic Active 1 (2%)
Tooth (12) (9)
Incisor, Upper, Dysplasia 10 (83%) 7 (78%)
Peridontal Tissue, Inflammation, Suppurative 1 (8%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 600 PPM 600 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50)
Artery, Inflammation, Chronic Active 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (48)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Hyperplasia 1 (2%)
Hypertrophy 2 (4%)
Thrombosis 1 (2%)
Adrenal Gland, Medulla (50) (48)
Hyperplasia 1 (2%)
Pituitary Gland (44) (41)
Pars Distalis, Hyperplasia 17 (39%) 17 (41%)
Thyroid Gland (49) (50)
Inflammation, Chronic Active 4 (8%)
Follicular Cell, Hyperplasia 15 (31%) 13 (26%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (50) (49)
Angiectasis 2 (4%) 2 (4%)
Cyst 13 (26%) 18 (37%)
Thrombosis 1 (2%) 1 (2%)
Uterus (50) (50)
Dilatation 3 (6%) 3 (6%)
Inflammation, Suppurative 2 (4%) 1 (2%)
Endometrium, Hyperplasia, Cystic 8 (16%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (50)
Femoral, Myelofibrosis 2 (4%) 3 (6%)
Lymph Node, Mesenteric (6) (6)
Angiectasis 1 (17%)
Hyperplasia, Lymphoid 1 (17%)
Spleen (50) (48)
Hematopoietic Cell Proliferation 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 600 PPM 600 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (50)
Cyst 1 (2%)
Mineralization 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (49)
Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50)
Inflammation, Chronic Active 1 (2%) 4 (8%)
Alveolar Epithelium, Hyperplasia 2 (4%)
Nose (50) (50)
Mucosa, Inflammation, Suppurative 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Metaplasia, Osseous 1 (2%)
Nephropathy, Chronic 14 (28%) 17 (34%)
Urinary Bladder (49) (49)
Artery, Inflammation, Chronic Active 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50 50 50
Early Deaths
Moribund Sacrifice 6 8 2 7 10 3
Natural Death 5 5 9 6 7 6
Survivors
Terminal Sacrifice 38 36 38 36 33 39
Moribund Sacrifice 1
Natural Death 1 1 1
Missing 1 1
Animals Examined Microscopically 50 50 50 49 50 49
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (46) (11) (8) (11) (10) (5)
Inflammation, Suppurative 1 (13%)
Intestine Large, Cecum (49) (13) (11) (12) (16) (7)
Parasite Metazoan 1 (2%)
Intestine Large, Colon (49) (13) (12) (13) (15) (7)
Parasite Metazoan 1 (2%) 1 (8%)
Intestine Large, Rectum (47) (13) (11) (12) (15) (8)
Parasite Metazoan 1 (2%) 1 (7%)
Prolapse 1 (13%)
Intestine Small, Duodenum (48) (12) (9) (10) (15) (7)
Hyperplasia, Atypical 1 (7%)
Inflammation, Acute, Necrotizing 1 (7%)
Inflammation, Chronic Active 1 (14%)
Intestine Small, Jejunum (50) (12) (17) (10) (16) (8)
Inflammation, Acute, Necrotizing 2 (4%) 1 (6%) 1 (6%)
Inflammation, Chronic Active 1 (6%)
Liver (50) (50) (50) (49) (50) (49)
Angiectasis 1 (2%)
Basophilic Focus 4 (8%) 3 (6%) 5 (10%) 1 (2%) 6 (12%)
Clear Cell Focus 7 (14%) 7 (14%) 2 (4%) 3 (6%) 4 (8%) 5 (10%)
Clear Cell Focus, Multiple 1 (2%)
Cyst 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Degeneration, Cystic 3 (6%) 2 (4%) 9 (18%) 7 (14%) 9 (18%)
Eosinophilic Focus 3 (6%) 2 (4%) 3 (6%) 3 (6%) 5 (10%)
Fatty Change 5 (10%) 2 (4%) 7 (14%) 4 (8%) 2 (4%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 1 (2%)
Hepatodiaphragmatic Nodule 1 (2%) 1 (2%)
Infarct, Multifocal 4 (8%) 8 (16%) 5 (10%) 11 (22%) 7 (14%) 6 (12%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mixed Cell Focus 3 (6%) 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Necrosis 2 (4%)
Necrosis, Multifocal 1 (2%)
Regeneration, Diffuse 1 (2%)
Bile Duct, Hyperplasia 2 (4%) 1 (2%)
Centrilobular, Congestion, Chronic 1 (2%)
Centrilobular, Cytomegaly 16 (32%) 5 (10%) 33 (67%) 20 (40%) 19 (39%)
Mesentery (3) (2) (2) (3)
Inflammation, Suppurative 1 (33%) 2 (67%)
Artery, Inflammation, Chronic Active 1 (33%) 1 (50%)
Fat, Necrosis 1 (50%)
Pancreas (50) (13) (11) (13) (17) (8)
Acinus, Atrophy 4 (8%) 1 (8%) 1 (9%) 1 (8%)
Acinus, Focal Cellular Change 1 (2%) 1 (8%)
Artery, Inflammation, Chronic Active 1 (8%)
Duct, Dilatation 1 (8%)
Stomach, Forestomach (50) (16) (11) (18) (15) (9)
Diverticulum 1 (6%)
Hyperplasia, Squamous 4 (22%) 1 (11%)
Epithelium, Hyperplasia 1 (2%) 2 (18%) 2 (11%)
Stomach, Glandular (50) (15) (9) (16) (13) (9)
Inflammation, Acute, Necrotizing 1 (2%)
Mineralization 1 (7%)
Tooth (36) (1) (5) (1) (2) (2)
Incisor, Upper, Dysplasia 36 (100%) 1 (100%) 5 (100%) 1 (100%) 2 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (14) (12) (13) (17) (10)
Bacterium 1 (10%)
Cardiomyopathy, Chronic Active 1 (8%) 1 (10%)
Atrium, Thrombosis 1 (8%)
Valve, Inflammation, Suppurative 1 (10%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (14) (11) (12) (17) (9)
Hyperplasia 4 (8%) 1 (7%) 1 (9%) 1 (6%)
Hypertrophy 17 (34%) 1 (7%) 2 (18%) 4 (33%)
Necrosis 1 (9%)
Adrenal Gland, Medulla (50) (14) (11) (11) (17) (9)
Hyperplasia 5 (10%)
Necrosis 1 (9%)
Islets, Pancreatic (50) (13) (10) (12) (17) (8)
Hyperplasia 1 (2%) 1 (8%) 1 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pituitary Gland (45) (11) (4) (10) (14) (7)
Pars Distalis, Hyperplasia 2 (4%)
Thyroid Gland (49) (14) (11) (13) (17) (9)
Follicle, Cyst Multilocular 1 (2%) 1 (7%)
Follicular Cell, Hyperplasia 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Preputial Gland (5) (2) (4) (2) (3) (8)
Inflammation, Chronic Active 1 (20%) 1 (50%) 1 (25%) 2 (67%) 3 (38%)
Duct, Dilatation 4 (80%) 1 (50%) 4 (100%) 2 (100%) 1 (33%) 4 (50%)
Prostate (50) (14) (12) (13) (17) (9)
Inflammation, Suppurative 2 (22%)
Artery, Inflammation, Chronic Active 1 (2%)
Seminal Vesicle (1) (1) (2) (1)
Inflammation, Chronic Active 1 (100%)
Testes (50) (14) (12) (13) (17) (9)
Degeneration 1 (8%) 1 (6%)
Inflammation, Acute, Necrotizing 1 (11%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (50) (30) (32) (27) (31) (23)
Deep Cervical, Edema 1 (4%)
Lumbar, Edema 1 (4%)
Mandibular, Angiectasis 1 (3%) 1 (4%) 1 (3%)
Mandibular, Edema 1 (3%) 1 (3%) 2 (6%)
Mandibular, Hyperplasia, Lymphoid 2 (6%) 1 (4%) 2 (6%)
Renal, Edema 1 (4%)
Lymph Node, Mesenteric (22) (22) (20) (16) (20) (15)
Angiectasis 15 (68%) 12 (55%) 15 (75%) 11 (69%) 9 (45%) 11 (73%)
Edema 2 (9%) 1 (6%)
Hyperplasia, Lymphoid 1 (5%) 1 (5%) 1 (6%) 2 (10%)
Spleen (49) (21) (18) (20) (25) (17)
Angiectasis, Focal 1 (2%)
Hematopoietic Cell Proliferation 4 (8%) 1 (5%) 3 (17%) 3 (15%) 4 (16%) 1 (6%)
Hyperplasia, Lymphoid 1 (5%) 3 (18%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (15) (13) (14) (20) (9)
Cyst Epithelial Inclusion 1 (8%)
Inflammation, Acute 2 (22%)
Inflammation, Chronic Active 2 (4%)
Subcutaneous Tissue, Fibrosis 1 (5%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (30) (40) (30) (37) (35)
Femur, Fibrosis, Focal 1 (2%)
Tarsal, Hyperostosis 28 (56%) 16 (53%) 31 (78%) 19 (63%) 22 (59%) 27 (77%)
Tarsal, Inflammation, Chronic Active 1 (3%)
Skeletal Muscle (1) (1) (1)
Artery, Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (14) (12) (13) (18) (10)
Compression 1 (8%)
Hemorrhage 1 (8%) 1 (6%)
Hydrocephalus 1 (6%)
Necrosis 1 (6%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (8%)
Meninges, Infiltration Cellular, Lymphocyte 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (19) (19) (21) (20) (22)
Inflammation, Chronic Active 2 (4%) 3 (16%) 3 (14%)
Metaplasia, Focal, Squamous 1 (2%)
Alveolar Epithelium, Hyperplasia 11 (22%) 1 (5%) 2 (10%) 1 (5%) 2 (9%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (3) (2) (3)
Degeneration 1 (50%) 1 (33%) 2 (100%) 3 (100%)
Cornea, Inflammation, Chronic Active 1 (50%) 1 (33%)
Harderian Gland (9) (2) (2) (2) (3) (4)
Hyperplasia 3 (33%)
Inflammation, Suppurative 1 (11%) 1 (50%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM O PPM 30 PPM 100 PPM 100 PPM 100 PPM
0-0 10-0 1-1 10-3 3-3 0-3
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (16) (12) (13) (18) (9)
Cyst 1 (2%)
Hydronephrosis 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
Metaplasia, Osseous 1 (2%)
Nephropathy, Chronic 36 (72%) 4 (25%) 6 (50%) 4 (31%) 9 (50%) 1 (11%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (8%)
Pelvis, Inflammation, Suppurative 1 (2%) 2 (22%)
Renal Tubule, Hyperplasia 1 (11%)
Urinary Bladder (49) (13) (12) (13) (18) (8)
Inflammation, Chronic Active 1 (2%) 2 (11%) 2 (25%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 300 PPM 300 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50
Early Deaths
Moribund Sacrifice 4 9
Natural Death 2 7
Survivors
Terminal Sacrifice 44 34
Animals Examined Microscopically 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (48) (50)
Inflammation, Acute, Necrotizing 1 (2%)
Intestine Large, Rectum (49) (48)
Parasite Metazoan 2 (4%) 1 (2%)
Intestine Small, Ileum (49) (46)
Inflammation, Acute, Necrotizing 1 (2%) 1 (2%)
Intestine Small, Jejunum (48) (48)
Inflammation, Chronic Active 1 (2%)
Parasite Metazoan 1 (2%)
Liver (50) (49)
Basophilic Focus 1 (2%) 3 (6%)
Clear Cell Focus 26 (52%) 20 (41%)
Degeneration, Cystic 39 (78%) 29 (59%)
Eosinophilic Focus 5 (10%) 2 (4%)
Hematopoietic Cell Proliferation 1 (2%)
Infarct, Multifocal 3 (6%) 2 (4%)
Inflammation, Chronic 1 (2%) 1 (2%)
Mixed Cell Focus 3 (6%)
Centrilobular, Cytomegaly 46 (92%) 37 (76%)
Mesentery (3) (4)
Artery, Inflammation, Chronic Active 1 (33%)
Pancreas (49) (49)
Acinus, Atrophy 6 (12%)
Acinus, Depletion Secretory 1 (2%)
Acinus, Focal Cellular Change 2 (4%)
Salivary Glands (50) (49)
Inflammation, Granulomatous 1 (2%)
Necrosis 1 (2%)
Acinus, Atrophy 1 (2%)
Stomach, Forestomach (49) (48)
Ulcer 1 (2%)
Epithelium, Hyperplasia 1 (2%) 2 (4%)
Stomach, Glandular (49) (47)
Inflammation, Acute, Necrotizing 4 (9%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 300 PPM 300 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Tooth (44) (39)
Incisor, Upper, Dysplasia 44 (100%) 38 (97%)
Peridontal Tissue, Inflammation, Suppurative 1 (2%) 1 (3%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (49)
Artery, Inflammation, Chronic Active 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (49) (49)
Hyperplasia 2 (4%) 4 (8%)
Hypertrophy 15 (31%) 7 (14%)
Islets, Pancreatic (49) (49)
Hyperplasia 1 (2%)
Thyroid Gland (50) (49)
Inflammation, Chronic Active 1 (2%)
Follicle, Cyst Multilocular 1 (2%)
Follicular Cell, Hyperplasia 4 (8%) 6 (12%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (50)
Inflammation, Chronic Active 1 (2%)
Preputial Gland (4) (8)
Inflammation, Chronic Active 3 (38%)
Duct, Dilatation 4 (100%) 7 (88%)
Prostate (50) (50)
Inflammation, Suppurative 3 (6%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50)
Femoral, Thrombosis 1 (2%)
Lymph Node (50) (47)
Mandibular, Angiectasis 1 (2%)
Mandibular, Edema 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 300 PPM 300 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Angiectasis 1 (2%)
Lymph Node, Mesenteric (18) (24)
Angiectasis 13 (72%) 13 (54%)
Spleen (49) (47)
Cyst 1 (2%)
Depletion Lymphoid 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 2 (4%)
Thymus (43) (41)
Atrophy 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (50)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50)
Femur, Hyperostosis 1 (2%)
Tarsal, Hyperostosis 9 (18%) 13 (26%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (49)
Inflammation, Acute 2 (4%)
Inflammation, Chronic Active 1 (2%) 2 (4%)
Alveolar Epithelium, Hyperplasia 1 (2%) 6 (12%)
Artery, Mediastinum, Inflammation, Chronic
Active 1 (2%)
Nose (50) (50)
Mucosa, Inflammation, Suppurative 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 17
NTP Experiment-Test: 05075-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIPHENYLHYDANTOIN Date: 09/09/94
Route: DOSED FEED Time: 15:41:56
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 300 PPM 300 PPM
10-10 0-10
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (1)
Degeneration 2 (100%) 1 (100%)
Harderian Gland (4) (5)
Hyperplasia 1 (25%) 1 (20%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50)
Embolus Bacterial 1 (2%)
Nephropathy, Chronic 39 (78%) 35 (70%)
Artery, Inflammation, Chronic Active 1 (2%)
Pelvis, Inflammation, Suppurative 2 (4%)
Urinary Bladder (50) (50)
Concretion 1 (2%)
Inflammation, Chronic Active 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 18
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