TDMS Study 05166-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
NTP Experiment-Test: 05166-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
Facility: Hazleton Laboratories America, Inc.
Chemical CAS #: 612-82-8
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: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 45 75 70
Scheduled Sacrifice 10 10
Early Deaths
Moribund 1 5 37 45
Dead 1 6 5
Survivors
Terminal Sacrifice 59 39 32 10
Animals Examined Microscopically 60 45 75 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (60) (45) (75) (60)
Edema 1 (2%)
Parasite Metazoan 1 (1%)
Intestine Large, Colon (60) (45) (75) (60)
Mineralization 2 (3%)
Parasite Metazoan 4 (7%) 2 (4%) 9 (12%) 6 (10%)
Intestine Large, Rectum (60) (45) (74) (60)
Parasite Metazoan 6 (10%) 7 (16%) 5 (7%) 5 (8%)
Intestine Small, Jejunum (60) (45) (74) (59)
Muscularis, Mineralization 1 (1%)
Liver (60) (45) (74) (60)
Angiectasis 6 (8%) 2 (3%)
Basophilic Focus 13 (29%) 11 (15%) 3 (5%)
Congestion 1 (2%)
Cyst 2 (3%)
Degeneration, Chronic 1 (1%)
Degeneration, Cystic 3 (7%) 12 (16%) 11 (18%)
Eosinophilic Focus 7 (16%) 57 (77%) 38 (63%)
Fatty Change, Multifocal 4 (5%) 2 (3%)
Hematocyst 1 (2%)
Hematopoietic Cell Proliferation 7 (16%) 19 (26%) 8 (13%)
Hemorrhage 1 (2%)
Hepatodiaphragmatic Nodule 7 (12%) 7 (16%) 7 (9%) 3 (5%)
Hyperplasia, Re Cell 1 (2%)
Inflammation, Acute, Multifocal 2 (3%)
Inflammation, Granulomatous, Multifocal 11 (18%) 19 (42%) 10 (14%) 10 (17%)
Inflammation, Multifocal, Suppurative 1 (2%)
Mixed Cell Focus 34 (76%) 49 (66%) 32 (53%)
Necrosis, Coagulative, Focal 1 (2%) 1 (2%)
Necrosis, Coagulative, Multifocal 2 (3%)
Necrosis, Focal 2 (4%) 5 (7%) 1 (2%)
Bile Duct, Cyst 2 (3%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Bile Duct, Hyperplasia 20 (33%) 2 (4%) 1 (1%)
Centrilobular, Necrosis 1 (2%)
Mesentery (3) (3) (1)
Hemorrhage 1 (33%)
Artery, Mineralization 1 (100%)
Fat, Necrosis, Focal 3 (100%) 2 (67%)
Pancreas (60) (45) (74) (60)
Inflammation, Chronic 1 (2%)
Acinus, Atrophy 5 (8%) 2 (4%) 1 (1%) 2 (3%)
Acinus, Hyperplasia, Focal 1 (1%)
Artery, Mineralization 1 (1%)
Pharynx (1) (8) (7)
Hyperplasia, Focal 1 (13%)
Salivary Glands (60) (43) (72) (60)
Inflammation, Chronic 1 (2%) 3 (4%) 1 (2%)
Stomach, Forestomach (60) (45) (74) (60)
Hyperplasia, Multifocal 1 (1%)
Inflammation, Chronic 1 (2%) 1 (2%)
Stomach, Glandular (60) (45) (74) (60)
Degeneration, Cystic 1 (2%) 3 (7%) 6 (8%) 11 (18%)
Erosion 2 (3%)
Erosion, Multifocal 1 (1%) 1 (2%)
Mineralization 5 (7%)
Ulcer 1 (1%)
Tongue (2) (3) (10)
Hyperkeratosis, Focal 1 (33%) 1 (10%)
Artery, Mineralization 1 (33%)
Tooth (2) (1)
Peridontal Tissue, Inflammation, Chronic
Active 2 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (45) (74) (60)
Cardiomyopathy 3 (4%) 3 (5%)
Mineralization 4 (5%)
Coronary Artery, Inflammation, Chronic 1 (2%)
Mitral Valve, Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (60) (45) (74) (60)
Angiectasis 8 (11%) 8 (13%)
Cyst 1 (2%)
Hematopoietic Cell Proliferation 1 (1%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia, Focal 2 (4%) 3 (4%) 1 (2%)
Vacuolization Cytoplasmic, Focal 2 (3%) 10 (14%) 5 (8%)
Vacuolization Cytoplasmic, Multifocal 1 (2%)
Bilateral, Angiectasis 1 (1%)
Bilateral, Hyperplasia, Multifocal 1 (1%)
Adrenal Gland, Medulla (60) (45) (74) (60)
Hyperplasia, Focal 2 (3%)
Parathyroid Gland (53) (44) (70) (58)
Hyperplasia 5 (7%) 3 (5%)
Pituitary Gland (58) (45) (75) (60)
Angiectasis 1 (2%) 6 (13%) 3 (4%) 1 (2%)
Cyst 17 (29%) 7 (16%) 11 (15%) 8 (13%)
Hemorrhage 2 (4%)
Pars Distalis, Hyperplasia 1 (2%)
Pars Distalis, Hyperplasia, Focal 2 (3%) 1 (2%) 2 (3%) 1 (2%)
Thyroid Gland (60) (45) (74) (60)
Ultimobranchial Cyst 2 (3%) 1 (2%) 7 (9%) 5 (8%)
C-Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (6) (3)
Mineralization 4 (67%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (60) (45) (75) (59)
Hyperplasia 1 (2%) 3 (4%)
Hyperplasia, Focal, Squamous 1 (1%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (1%) 1 (2%)
Bilateral, Duct, Ectasia 1 (2%)
Duct, Ectasia 6 (10%) 2 (4%) 12 (16%) 5 (8%)
Ovary (60) (44) (75) (60)
Cyst 2 (5%)
Bilateral, Periovarian Tissue, Cyst 1 (1%)
Periovarian Tissue, Cyst 3 (5%) 4 (9%) 3 (4%) 2 (3%)
Uterus (60) (44) (75) (60)
Fibrosis 1 (1%)
Hydrometra 5 (8%) 3 (7%) 1 (1%)
Pigmentation, Focal, Hemosiderin 1 (2%)
Thrombosis 1 (2%)
Cervix, Dilatation 1 (1%)
Endometrium, Cyst 3 (4%)
Endometrium, Hyperplasia, Papillary 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1)
Anemia 1 (100%)
Bone Marrow (60) (45) (73) (59)
Atrophy 1 (1%) 4 (7%)
Hemorrhage 2 (3%) 4 (7%)
Hyperplasia 7 (12%)
Hyperplasia, Multifocal, Re Cell 1 (2%)
Lymph Node (60) (45) (75) (60)
Hemorrhage 1 (2%)
Deep Cervical, Hyperplasia, Plasma Cell 1 (1%)
Iliac, Hyperplasia, Plasma Cell 1 (2%)
Inguinal, Hyperplasia, Plasma Cell 1 (1%)
Mediastinal, Hemorrhage 21 (35%) 7 (16%) 4 (5%) 3 (5%)
Mediastinal, Hyperplasia, Plasma Cell 2 (3%)
Mediastinal, Pigmentation, Hemosiderin 1 (2%) 2 (3%)
Mediastinal, Sinus, Infiltration Cellular,
Histiocyte 1 (1%)
Renal, Hemorrhage 2 (3%)
Lymph Node, Mandibular (60) (43) (72) (60)
Hemorrhage 3 (5%) 2 (5%) 3 (4%) 2 (3%)
Hyperplasia, Lymphoid 1 (2%) 2 (5%) 2 (3%) 2 (3%)
Hyperplasia, Plasma Cell 1 (2%) 5 (12%) 20 (28%) 18 (30%)
Sinus, Ectasia 3 (5%) 3 (7%) 2 (3%) 1 (2%)
Lymph Node, Mesenteric (60) (45) (73) (60)
Atrophy 2 (3%) 1 (2%)
Hemorrhage 1 (1%)
Spleen (60) (45) (74) (60)
Depletion Lymphoid 1 (1%)
Fibrosis 2 (3%)
Fibrosis, Focal 1 (1%)
Hematopoietic Cell Proliferation 6 (13%) 20 (27%) 14 (23%)
Hemorrhage, Multifocal 1 (2%)
Pigmentation, Hemosiderin 1 (1%)
Red Pulp, Atrophy 2 (3%)
Thymus (54) (32) (67) (45)
Cyst 2 (6%) 1 (2%)
Depletion Lymphoid 1 (2%)
Hemorrhage 1 (2%)
Epithelial Cell, Hyperplasia 7 (13%) 15 (47%) 17 (25%) 3 (7%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (56) (42) (73) (54)
Fibrosis, Focal 1 (2%)
Duct, Ectasia 2 (4%) 1 (2%)
Skin (60) (45) (75) (59)
Acanthosis 3 (7%) 1 (2%)
Cyst Epithelial Inclusion 1 (1%) 3 (5%)
Inflammation, Chronic Active 2 (3%) 1 (2%)
Ulcer 1 (2%)
Epidermis, Hyperplasia, Basal Cell, Focal 1 (1%)
Hair Follicle, Hyperplasia, Basal Cell, Focal 1 (1%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (2) (2) (1)
Cranium, Fibrous Osteodystrophy 2 (100%) 1 (100%)
Cranium, Osteopetrosis 1 (50%)
Sternum, Fibrous Osteodystrophy 1 (50%)
Sternum, Osteopetrosis 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (45) (75) (60)
Brain Stem, Compression 1 (2%) 1 (1%)
Brain Stem, Hemorrhage 1 (1%)
Cerebellum, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (45) (74) (60)
Congestion 1 (1%) 2 (3%)
Edema 1 (2%)
Foreign Body 1 (2%)
Hemorrhage 2 (3%) 2 (3%)
Infiltration Cellular, Histiocyte 12 (20%) 23 (51%) 36 (49%) 29 (48%)
Metaplasia, Focal, Osseous 1 (1%)
Metaplasia, Squamous 1 (1%)
Mineralization 2 (3%)
Pigmentation 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 7 (16%) 20 (27%) 7 (12%)
Alveolar Epithelium, Hyperplasia, Multifocal 4 (9%) 10 (14%) 6 (10%)
Artery, Mineralization 1 (1%)
Bronchiole, Inflammation, Suppurative 1 (2%)
Interstitium, Inflammation 4 (5%) 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Peribronchiolar, Alveolus, Inflammation,
Suppurative 1 (2%)
Nose (60) (44) (75) (60)
Foreign Body 1 (2%)
Fungus 1 (1%)
Hemorrhage 5 (8%) 2 (3%) 4 (7%)
Inflammation, Suppurative 6 (8%) 5 (8%)
Olfactory Epithelium, Hyperplasia, Focal 1 (1%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Pinna, Ulcer 1 (100%)
Eye (1) (4) (4)
Anterior Chamber, Hemorrhage 2 (50%)
Cornea, Inflammation, Suppurative 3 (75%) 3 (75%)
Harderian Gland (1) (1)
Pigmentation, Porphyrin 1 (100%) 1 (100%)
Zymbal's Gland (57) (44) (73) (60)
Cyst 1 (2%) 1 (2%)
Ectasia 4 (5%)
Hyperplasia, Focal, Glandular 3 (7%) 3 (4%)
Hyperplasia, Focal, Squamous 1 (2%) 4 (5%) 2 (3%)
Hypertrophy 3 (4%) 3 (5%)
Inflammation, Chronic Active 1 (1%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (45) (74) (60)
Hemorrhage 1 (2%)
Karyomegaly 28 (62%) 61 (82%) 56 (93%)
Nephropathy 47 (78%) 44 (98%) 72 (97%) 59 (98%)
Medulla, Inflammation, Suppurative 1 (2%)
Urinary Bladder (60) (45) (75) (60)
Dilatation 2 (3%)
Hemorrhage 1 (1%)
Hyperplasia, Papillary 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 45 75 70
Scheduled Sacrifice 10 10
Early Deaths
Moribund 2 19 45
Dead 2 5 15
Accident 1
Survivors
Terminal Sacrifice 60 41 49
Dead 1
Animals Examined Microscopically 60 45 75 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (60) (45) (75) (58)
Hemorrhage 1 (1%)
Inflammation, Suppurative 1 (2%)
Parasite Metazoan 2 (3%) 2 (4%) 2 (3%)
Intestine Large, Colon (60) (45) (75) (58)
Parasite Metazoan 8 (13%) 6 (13%) 8 (11%) 9 (16%)
Artery, Inflammation, Necrotizing 1 (2%)
Intestine Large, Rectum (60) (44) (75) (60)
Parasite Metazoan 8 (13%) 8 (18%) 5 (7%) 5 (8%)
Intestine Small, Ileum (60) (44) (75) (54)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Liver (60) (45) (75) (60)
Angiectasis 3 (5%)
Basophilic Focus 1 (2%) 31 (69%) 54 (72%) 27 (45%)
Congestion 1 (1%)
Degeneration, Cystic 24 (53%) 67 (89%) 51 (85%)
Eosinophilic Focus 57 (76%) 53 (88%)
Fatty Change, Diffuse 1 (1%)
Fatty Change, Focal 1 (2%) 1 (2%) 1 (2%)
Fatty Change, Multifocal 1 (2%) 6 (10%)
Hematocyst 1 (2%)
Hematopoietic Cell Proliferation 2 (4%) 27 (36%) 15 (25%)
Hemorrhage, Focal 1 (2%)
Hepatodiaphragmatic Nodule 3 (5%) 1 (2%) 3 (4%) 6 (10%)
Infarct 1 (2%) 3 (4%)
Inflammation, Acute, Focal 3 (5%)
Inflammation, Acute, Multifocal 1 (2%) 1 (2%)
Inflammation, Granulomatous, Multifocal 1 (2%) 5 (11%) 3 (4%) 2 (3%)
Mixed Cell Focus 37 (82%) 54 (72%) 30 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Necrosis, Coagulative, Focal 1 (2%)
Necrosis, Coagulative, Multifocal 1 (2%) 2 (3%)
Necrosis, Focal 2 (3%) 4 (9%) 9 (12%) 1 (2%)
Necrosis, Multifocal 1 (1%) 1 (2%)
Bile Duct, Hyperplasia 39 (65%) 3 (7%) 2 (3%) 1 (2%)
Bile Duct, Hyperplasia, Focal, Adenomatous 1 (2%)
Biliary Tract, Inflammation, Subacute 1 (1%)
Caudate Lobe, Infarct 1 (2%) 1 (1%)
Caudate Lobe, Regeneration 1 (2%)
Caudate Lobe, Periportal, Fibrosis 1 (2%)
Centrilobular, Necrosis, Coagulative 1 (2%) 1 (1%) 5 (8%)
Serosa, Cyst 1 (2%)
Serosa, Fibrosis, Focal 1 (2%)
Serosa, Pigmentation, Focal, Hemosiderin 1 (2%)
Mesentery (2) (6) (6) (7)
Hemorrhage 1 (50%)
Inflammation, Granulomatous 1 (14%)
Artery, Inflammation, Chronic 1 (17%)
Artery, Mineralization 5 (71%)
Fat, Necrosis, Focal 2 (100%) 5 (83%) 6 (100%) 1 (14%)
Pancreas (60) (44) (75) (57)
Inflammation, Chronic 1 (2%) 1 (1%)
Acinus, Atrophy 9 (15%) 4 (9%) 7 (9%)
Artery, Mineralization 1 (2%)
Salivary Glands (60) (45) (74) (60)
Inflammation, Chronic Active 1 (1%)
Necrosis 1 (2%)
Acinus, Atrophy 1 (1%) 2 (3%)
Stomach, Forestomach (60) (45) (75) (59)
Erosion, Focal 1 (1%)
Hyperplasia 1 (1%)
Ulcer 2 (3%) 1 (2%)
Stomach, Glandular (60) (45) (75) (59)
Degeneration, Cystic 22 (37%) 4 (5%) 15 (25%)
Ectopic Tissue 1 (1%)
Erosion 1 (2%)
Mineralization 8 (14%)
Ulcer 1 (2%)
Ulcer, Multifocal 1 (2%)
Tongue (1) (3)
Hyperplasia, Focal 1 (33%)
Tooth (1)
Dysplasia 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (45) (75) (59)
Cardiomyopathy 17 (28%) 19 (42%) 35 (47%) 31 (53%)
Dilatation 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization 6 (10%)
Atrium, Dilatation 1 (1%)
Atrium, Thrombosis 2 (3%)
Mitral Valve, Inflammation, Chronic 1 (2%)
Mitral Valve, Thrombosis 2 (3%)
Myocardium, Inflammation, Acute 1 (2%)
Myocardium, Inflammation, Chronic Active 1 (2%)
Myocardium, Necrosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (60) (44) (75) (59)
Angiectasis 1 (2%)
Hematopoietic Cell Proliferation 1 (1%)
Hyperplasia, Focal 1 (1%)
Vacuolization Cytoplasmic, Focal 5 (7%) 5 (8%)
Adrenal Gland, Medulla (60) (45) (75) (59)
Hyperplasia, Focal 1 (1%)
Bilateral, Hyperplasia, Focal 1 (2%)
Parathyroid Gland (55) (45) (71) (58)
Hyperplasia 11 (19%)
Pituitary Gland (60) (45) (75) (60)
Angiectasis 1 (1%)
Cyst 2 (3%) 2 (4%) 1 (1%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 2 (3%) 3 (4%) 1 (2%)
Thyroid Gland (60) (44) (75) (60)
Ultimobranchial Cyst 3 (5%) 1 (1%) 7 (12%)
C-Cell, Hyperplasia 1 (2%) 1 (1%)
Follicle, Cyst 1 (1%)
Follicular Cell, Hyperplasia, Focal 1 (1%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (4)
Inflammation, Chronic 1 (100%)
Mineralization 3 (75%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (45) (75) (60)
Inflammation, Chronic 1 (1%)
Inflammation, Suppurative 1 (2%)
Arteriole, Inflammation, Chronic 1 (1%)
Preputial Gland (60) (45) (75) (60)
Atrophy 1 (1%) 1 (2%)
Hyperplasia, Focal 1 (1%) 3 (5%)
Hyperplasia, Focal, Squamous 2 (3%)
Inflammation, Chronic Active 7 (12%) 2 (4%) 9 (12%) 8 (13%)
Duct, Ectasia 2 (3%) 2 (4%) 7 (9%) 13 (22%)
Prostate (60) (45) (75) (60)
Hyperplasia, Focal 1 (2%) 2 (4%) 3 (5%)
Hyperplasia, Multifocal 1 (1%)
Inflammation, Acute 1 (1%)
Inflammation, Chronic Active 35 (58%) 28 (62%) 32 (43%) 15 (25%)
Inflammation, Subacute 1 (1%)
Inflammation, Suppurative 1 (2%) 2 (3%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Seminal Vesicle (60) (44) (75) (58)
Atrophy 1 (2%) 8 (11%) 5 (9%)
Hyperplasia, Focal 2 (3%)
Testes (60) (45) (75) (60)
Hemorrhage 1 (1%) 1 (2%)
Hypospermia 9 (15%) 3 (7%) 5 (7%) 6 (10%)
Mineralization 3 (5%) 1 (2%)
Interstitial Cell, Hyperplasia 44 (73%) 35 (78%) 28 (37%) 4 (7%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (44) (75) (60)
Atrophy 8 (13%)
Hemorrhage 8 (13%)
Hyperplasia 1 (1%) 3 (5%)
Proliferation Connective Tissue 1 (2%)
Lymph Node (60) (45) (75) (60)
Bronchial, Hemorrhage 1 (2%)
Deep Cervical, Hyperplasia, Plasma Cell 1 (1%)
Mediastinal, Hemorrhage 5 (8%) 6 (13%) 9 (12%) 7 (12%)
Mediastinal, Hyperplasia, Lymphoid 2 (3%) 1 (2%)
Mediastinal, Hyperplasia, Plasma Cell 1 (2%) 1 (1%)
Mediastinal, Hyperplasia, Re Cell 1 (1%)
Mediastinal, Infiltration Cellular,
Polymorphonuclear 1 (2%)
Mediastinal, Pigmentation, Hemosiderin 2 (3%) 1 (2%)
Mediastinal, Sinus, Infiltration Cellular,
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Histiocyte 1 (1%)
Pancreatic, Hemorrhage 1 (2%)
Lymph Node, Mandibular (60) (45) (74) (60)
Hemorrhage 2 (3%) 1 (2%)
Hyperplasia, Lymphoid 3 (5%)
Hyperplasia, Plasma Cell 2 (3%) 5 (11%) 18 (24%) 16 (27%)
Sinus, Ectasia 2 (4%) 3 (4%) 1 (2%)
Lymph Node, Mesenteric (60) (44) (75) (56)
Atrophy 1 (2%)
Hemorrhage 1 (2%) 2 (3%) 1 (2%)
Hyperplasia, Re Cell 1 (2%)
Infiltration Cellular, Polymorphonuclear 1 (2%)
Sinus, Ectasia 1 (1%) 1 (2%)
Spleen (60) (45) (75) (55)
Congestion 1 (1%) 3 (5%)
Depletion Lymphoid 1 (2%) 3 (5%)
Fibrosis 1 (2%) 1 (1%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 22 (29%) 11 (20%)
Hyperplasia, Focal, Re Cell 1 (2%)
Necrosis 2 (4%)
Necrosis, Multifocal 1 (2%)
Thrombosis 1 (1%)
Capsule, Fibrosis, Focal 1 (2%)
Capsule, Hematopoietic Cell Proliferation 1 (2%)
Red Pulp, Necrosis 1 (2%)
Thymus (47) (40) (50) (48)
Congestion 1 (2%)
Cyst 1 (2%)
Depletion Lymphoid 3 (6%)
Ectopic Parathyroid Gland 1 (2%)
Hemorrhage 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 1 (2%)
Epithelial Cell, Hyperplasia 9 (19%) 9 (23%) 4 (8%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (44) (75) (60)
Acanthosis 1 (1%) 1 (2%)
Cyst Epithelial Inclusion 1 (1%)
Erosion, Focal 1 (2%)
Fibrosis, Focal 2 (3%)
Fibrosis, Multifocal 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (1%)
Ulcer 1 (2%)
Hair Follicle, Hyperplasia, Basal Cell, Focal 4 (5%) 1 (2%)
Hair Follicle, Hyperplasia, Basal Cell,
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Multifocal 1 (1%) 1 (2%)
Sebaceous Gland, Hyperplasia, Focal 6 (8%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (5)
Cranium, Fibrous Osteodystrophy 5 (100%)
Sternum, Fibrous Osteodystrophy 3 (60%)
Sternum, Osteopetrosis 2 (40%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (45) (75) (60)
Brain Stem, Inflammation, Acute 1 (2%)
Cerebellum, Necrosis 1 (2%)
Cerebrum, Hemorrhage 2 (3%)
Cerebrum, Hemorrhage, Multifocal 1 (1%)
Cerebrum, Necrosis, Focal 1 (1%) 1 (2%)
Thalamus, Cyst 1 (1%)
Thalamus, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (45) (75) (60)
Congestion 2 (3%) 1 (2%)
Embolus 1 (1%)
Foreign Body 1 (1%)
Granuloma 1 (2%)
Hemorrhage 1 (2%)
Infiltration Cellular, Histiocyte 9 (15%) 3 (7%) 13 (17%) 13 (22%)
Inflammation, Focal, Granulomatous 1 (2%)
Mineralization 4 (7%)
Necrosis, Focal 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 5 (8%) 11 (24%) 19 (25%) 8 (13%)
Alveolar Epithelium, Hyperplasia, Multifocal 3 (7%) 12 (16%) 9 (15%)
Capillary, Thrombosis 1 (2%)
Interstitium, Inflammation 3 (4%) 4 (7%)
Nose (60) (45) (75) (60)
Foreign Body 2 (3%) 2 (4%) 1 (1%)
Fungus 1 (2%) 1 (1%)
Hemorrhage 5 (8%) 5 (11%) 1 (1%)
Inflammation, Acute 1 (2%)
Inflammation, Suppurative 2 (3%) 4 (9%) 3 (4%) 1 (2%)
Trachea (60) (45) (75) (60)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Inflammation, Suppurative 1 (1%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (4)
Cataract 1 (100%) 1 (25%)
Cornea, Inflammation, Chronic Active 1 (25%)
Cornea, Inflammation, Suppurative 2 (50%)
Retina, Degeneration 1 (100%)
Zymbal's Gland (59) (45) (75) (59)
Cyst 1 (1%)
Ectasia 1 (1%) 5 (8%)
Hyperplasia, Focal, Glandular 1 (1%) 1 (2%)
Hyperplasia, Focal, Squamous 7 (12%)
Hypertrophy 1 (2%)
Inflammation, Acute 1 (1%)
Inflammation, Chronic Active 2 (3%)
Inflammation, Granulomatous 1 (1%)
Bilateral, Hyperplasia, Focal, Glandular 1 (1%)
Bilateral, Hyperplasia, Focal, Squamous 3 (5%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (45) (75) (59)
Cyst 1 (2%) 1 (1%) 1 (2%)
Degeneration, Hyaline 1 (1%)
Hydronephrosis 1 (2%) 1 (2%) 1 (1%) 1 (2%)
Inflammation, Acute 2 (3%)
Inflammation, Suppurative 1 (2%)
Nephropathy 60 (100%) 43 (96%) 74 (99%) 59 (100%)
Renal Tubule, Hyperplasia, Focal 1 (2%)
Renal Tubule, Necrosis 1 (2%)
Transitional Epithelium, Hyperplasia,
Multifocal 1 (2%)
Urinary Bladder (60) (45) (75) (59)
Dilatation 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%)
Lumen, Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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