TDMS Study 05172-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE
NTP Experiment-Test: 05172-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
Facility: Hazleton Laboratories America, Inc.
Chemical CAS #: 20325400
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: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 45 75 70
Scheduled Sacrifice 10 10
Early Deaths
Moribund 10 27 60 51
Dead 5 3 9 9
Survivors
Terminal Sacrifice 45 15 6
Animals Examined Microscopically 60 45 75 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (60) (44) (75) (58)
Hemorrhage, Focal 1 (1%) 1 (2%)
Parasite Metazoan 1 (2%)
Submucosa, Inflammation, Acute 1 (2%)
Intestine Large, Colon (60) (44) (75) (59)
Parasite Metazoan 1 (2%) 1 (1%) 1 (2%)
Descending Colon, Hemorrhage, Focal 1 (1%)
Muscularis, Mineralization 1 (2%)
Intestine Large, Rectum (60) (43) (74) (59)
Parasite Metazoan 3 (4%) 3 (5%)
Liver (60) (44) (75) (60)
Angiectasis 1 (2%)
Angiectasis, Focal 1 (2%) 1 (2%)
Basophilic Focus 44 (73%) 34 (77%) 54 (72%) 48 (80%)
Clear Cell Focus 7 (12%) 11 (25%) 18 (24%) 15 (25%)
Cyst 1 (2%)
Degeneration, Cystic 1 (2%) 2 (5%) 3 (5%)
Degeneration, Cystic, Focal 1 (1%) 2 (3%)
Eosinophilic Focus 5 (8%) 7 (16%) 20 (27%) 28 (47%)
Fatty Change 1 (2%) 1 (2%) 4 (5%) 1 (2%)
Granuloma 10 (17%) 3 (7%) 7 (9%) 5 (8%)
Hematopoietic Cell Proliferation 1 (2%) 18 (41%) 43 (57%) 41 (68%)
Hepatodiaphragmatic Nodule 5 (8%) 6 (14%) 4 (5%) 1 (2%)
Hepatodiaphragmatic Nodule, Multiple 1 (2%) 1 (1%)
Necrosis, Coagulative 1 (1%) 3 (5%)
Necrosis, Focal 5 (7%) 9 (15%)
Necrosis, Multifocal 1 (2%) 1 (1%) 1 (2%)
Pigmentation 1 (2%)
Regeneration, Diffuse 6 (10%) 2 (5%) 2 (3%) 1 (2%)
Regeneration, Focal 1 (1%)
Regeneration, Multifocal 1 (2%) 2 (3%) 3 (5%)
Thrombosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Vacuolization Cytoplasmic, Diffuse 3 (4%) 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%) 1 (2%) 2 (3%)
Vacuolization Cytoplasmic, Multifocal 2 (3%) 1 (1%)
Bile Duct, Hyperplasia 1 (2%) 1 (2%) 2 (3%)
Bile Duct, Inflammation, Chronic 1 (2%)
Centrilobular, Degeneration 1 (2%) 1 (2%) 1 (1%) 1 (2%)
Centrilobular, Degeneration, Diffuse 2 (5%) 7 (9%) 4 (7%)
Centrilobular, Necrosis 1 (2%) 1 (2%) 1 (1%)
Centrilobular, Necrosis, Diffuse 1 (2%) 5 (7%) 5 (8%)
Kupffer Cell, Pigmentation 1 (2%)
Mesentery (6) (1) (8) (7)
Fat, Accessory Spleen 1 (13%)
Fat, Necrosis 6 (100%) 1 (100%) 5 (63%) 5 (71%)
Pancreas (60) (43) (75) (59)
Atrophy 4 (7%) 4 (9%) 4 (5%)
Hemorrhage, Focal 1 (2%)
Pharynx (1) (1) (6) (2)
Mucosa, Palate, Hyperplasia, Focal 2 (33%) 1 (50%)
Palate, Hyperkeratosis, Focal 1 (100%)
Salivary Glands (59) (44) (75) (59)
Atrophy 1 (2%) 2 (3%)
Inflammation, Chronic 1 (2%)
Stomach, Forestomach (60) (44) (74) (58)
Acanthosis 3 (4%) 1 (2%)
Hyperkeratosis 1 (1%)
Stomach, Glandular (60) (44) (75) (59)
Erosion, Focal 1 (2%) 1 (1%) 2 (3%)
Erosion, Multifocal 1 (1%)
Inflammation, Acute 1 (2%)
Mineralization 2 (3%)
Necrosis, Multifocal 1 (1%)
Tongue (1) (2) (5) (4)
Hyperplasia, Focal 2 (40%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (45) (75) (60)
Cardiomyopathy, Chronic 25 (42%) 17 (38%) 21 (28%) 17 (28%)
Artery, Mineralization, Multifocal 1 (2%)
Atrium, Thrombosis 1 (2%) 1 (2%)
Epicardium, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (60) (45) (75) (60)
Congestion 1 (1%)
Degeneration, Focal 1 (2%) 1 (2%)
Ectasia 1 (1%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Focal 5 (8%) 1 (2%)
Hyperplasia, Multifocal 1 (1%)
Hypertrophy, Focal 2 (3%) 3 (7%) 1 (1%) 1 (2%)
Hypertrophy, Multifocal 1 (1%)
Infiltration Cellular, Lymphocyte 1 (2%)
Necrosis, Focal 1 (2%)
Vacuolization Cytoplasmic, Diffuse 1 (1%) 3 (5%)
Vacuolization Cytoplasmic, Focal 2 (3%) 1 (2%)
Adrenal Gland, Medulla (60) (45) (74) (59)
Hematopoietic Cell Proliferation 1 (1%) 1 (2%)
Hyperplasia, Focal 5 (8%) 1 (1%) 3 (5%)
Hyperplasia, Multifocal 1 (2%)
Parathyroid Gland (58) (43) (70) (59)
Hyperplasia 1 (2%)
Pituitary Gland (60) (45) (75) (60)
Pigmentation 1 (1%)
Pars Distalis, Angiectasis 3 (5%) 4 (9%) 3 (4%) 1 (2%)
Pars Distalis, Cyst 14 (23%) 10 (22%) 17 (23%) 19 (32%)
Pars Distalis, Hemorrhage 1 (2%)
Pars Distalis, Hyperplasia 1 (2%)
Pars Distalis, Hyperplasia, Diffuse 1 (2%) 2 (4%)
Pars Distalis, Hyperplasia, Focal 5 (8%) 4 (9%) 7 (9%) 2 (3%)
Pars Distalis, Hyperplasia, Multifocal 1 (2%) 1 (1%)
Pars Distalis, Necrosis, Focal 1 (1%) 1 (2%)
Pars Distalis, Pigmentation, Focal 1 (2%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (60) (44) (75) (59)
C-Cell, Hyperplasia, Focal 6 (10%) 4 (9%) 1 (1%) 3 (5%)
C-Cell, Hyperplasia, Multifocal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (58) (44) (74) (55)
Atrophy 3 (5%) 2 (3%) 2 (4%)
Cyst 1 (1%)
Ectasia 15 (26%) 11 (25%) 11 (15%) 12 (22%)
Hyperplasia, Focal 3 (5%) 4 (9%) 7 (9%) 5 (9%)
Hyperplasia, Focal, Squamous 1 (2%) 2 (5%) 1 (2%)
Hyperplasia, Multifocal 2 (5%)
Hyperplasia, Multifocal, Squamous 1 (2%) 1 (1%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic Active 1 (1%)
Necrosis 1 (2%)
Ovary (60) (45) (75) (58)
Cyst 6 (10%) 7 (16%) 4 (5%) 4 (7%)
Bilateral, Cyst 1 (2%)
Germinal Epithelium, Hyperplasia, Focal,
Papillary 1 (2%)
Oviduct (1)
Thrombosis 1 (100%)
Uterus (60) (45) (75) (59)
Cyst 1 (2%)
Fibrosis 2 (3%)
Hydrometra 3 (5%) 1 (2%) 4 (5%) 2 (3%)
Inflammation, Acute 1 (2%)
Thrombosis 1 (2%)
Bilateral, Hydrometra 1 (2%)
Cervix, Cyst 2 (3%)
Cervix, Fibrosis 11 (18%) 3 (7%) 1 (1%)
Cervix, Prolapse 1 (2%)
Endometrium, Cyst 1 (2%) 2 (4%) 6 (8%) 3 (5%)
Vagina (1) (1)
Thrombosis, Multiple 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (45) (75) (60)
Hyperplasia 5 (8%) 8 (18%) 9 (12%) 14 (23%)
Hypoplasia 2 (3%)
Myelofibrosis 1 (2%) 1 (2%) 1 (1%)
Lymph Node (60) (45) (75) (60)
Axillary, Hyperplasia, Lymphoid 3 (5%)
Mediastinal, Congestion 1 (2%)
Mediastinal, Erythrophagocytosis 1 (2%)
Mediastinal, Hemorrhage 1 (1%) 2 (3%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%) 4 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Infiltration Cellular,
Histiocyte 1 (2%) 1 (2%)
Mediastinal, Pigmentation 1 (2%)
Pancreatic, Congestion 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 2 (3%)
Pancreatic, Pigmentation 1 (2%) 1 (1%)
Lymph Node, Mandibular (59) (44) (74) (59)
Congestion 3 (4%)
Hemorrhage 1 (1%) 1 (2%)
Hyperplasia, Lymphoid 2 (3%) 3 (7%) 3 (4%) 4 (7%)
Hyperplasia, Reticulum Cell 1 (2%) 1 (1%)
Lymph Node, Mesenteric (60) (44) (75) (58)
Atrophy 1 (1%) 2 (3%)
Erythrophagocytosis 1 (2%)
Hemorrhage 1 (1%)
Hyperplasia, Lymphoid 1 (1%)
Hyperplasia, Reticulum Cell 2 (3%) 3 (7%) 18 (24%) 18 (31%)
Spleen (60) (44) (75) (60)
Atrophy 1 (1%) 2 (3%)
Hematopoietic Cell Proliferation 3 (5%) 22 (50%) 50 (67%) 47 (78%)
Hemorrhage, Focal 1 (1%)
Hyperplasia, Reticulum Cell 1 (2%)
Infarct 1 (1%)
Pigmentation 5 (8%) 1 (2%) 1 (1%) 2 (3%)
Thymus (53) (41) (68) (54)
Atrophy 1 (1%)
Congestion 1 (1%)
Hemorrhage, Focal 2 (3%)
Epithelial Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (59) (43) (75) (59)
Galactocele 2 (3%) 1 (2%) 1 (2%)
Duct, Ectasia 16 (27%) 7 (16%) 12 (16%) 5 (8%)
Skin (60) (45) (75) (60)
Acanthosis 1 (2%)
Inflammation, Chronic 1 (2%)
Hair Follicle, Hyperplasia, Basal Cell,
Multifocal 1 (2%)
Subcutaneous Tissue, Abscess, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (2) (5) (8) (4)
Sternum, Osteopetrosis 2 (100%) 4 (80%) 7 (88%) 4 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (45) (75) (60)
Cerebrum, Compression 8 (13%) 2 (4%)
Cerebrum, Necrosis, Focal 1 (2%)
Meninges, Infiltration Cellular, Mononuclear
Cell 1 (1%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (45) (75) (60)
Congestion 1 (2%)
Foreign Body 1 (2%)
Hemorrhage, Focal 1 (2%)
Hyperplasia, Lymphoid 45 (75%) 31 (69%) 60 (80%) 53 (88%)
Infiltration Cellular, Histiocyte 3 (7%) 4 (5%) 18 (30%)
Inflammation, Acute, Multifocal 1 (2%)
Inflammation, Focal, Suppurative 1 (2%)
Parasite Metazoan 1 (2%)
Thrombosis 1 (1%)
Alveolar Epithelium, Hyperplasia, Focal 5 (8%) 1 (2%) 5 (7%) 2 (3%)
Alveolar Epithelium, Hyperplasia, Multifocal 1 (2%)
Alveolus, Pigmentation 2 (3%)
Bronchiole, Hyperplasia, Multifocal 1 (2%)
Nose (60) (45) (75) (60)
Fungus 2 (4%) 2 (3%)
Hyperkeratosis, Focal 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%) 2 (3%)
Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (3) (5)
Cataract 2 (67%) 3 (60%)
Inflammation, Chronic Active 1 (20%)
Synechia 1 (33%) 1 (20%)
Cornea, Necrosis 1 (20%)
Retina, Degeneration 2 (67%) 3 (60%)
Harderian Gland (2) (1) (1)
Inflammation, Chronic 1 (50%) 1 (100%) 1 (100%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Zymbal's Gland (60) (45) (75) (60)
Ectasia 12 (20%) 21 (47%) 29 (39%) 15 (25%)
Hyperplasia, Focal 2 (4%) 6 (8%) 5 (8%)
Hyperplasia, Focal, Squamous 3 (7%) 7 (9%) 8 (13%)
Hyperplasia, Multifocal 1 (1%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (45) (75) (60)
Atrophy 1 (1%)
Hydronephrosis 3 (4%)
Infarct, Chronic 1 (2%) 2 (4%) 1 (1%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 1 (2%)
Nephropathy, Chronic 50 (83%) 28 (62%) 38 (51%) 37 (62%)
Cortex, Cyst 1 (2%) 2 (3%)
Medulla, Inflammation, Acute 1 (2%)
Pelvis, Dilatation 1 (2%)
Renal Tubule, Degeneration, Hyaline 2 (4%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Mineralization 2 (3%)
Renal Tubule, Necrosis, Focal 1 (2%)
Renal Tubule, Pigmentation 2 (3%) 5 (7%) 7 (12%)
Renal Tubule, Vacuolization Cytoplasmic 1 (2%) 1 (2%)
Transitional Epithelium, Hyperplasia, Focal 1 (1%)
Ureter (2) (2) (1)
Dilatation 2 (100%) 1 (100%)
Urinary Bladder (60) (45) (75) (59)
Hemorrhage 1 (2%) 1 (1%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 70 45 75 70
Scheduled Sacrifice 10 10
Early Deaths
Dead 9 9 25 14
Moribund 7 28 50 46
Survivors
Terminal Sacrifice 44 8
Animals Examined Microscopically 60 45 75 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (44) (75) (60)
Hyperkeratosis 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Intestine Large, Cecum (60) (42) (72) (58)
Congestion 1 (1%)
Mucosa, Necrosis, Focal 1 (2%)
Submucosa, Edema 1 (2%)
Intestine Large, Colon (60) (43) (73) (58)
Parasite Metazoan 2 (3%) 2 (3%)
Intestine Large, Rectum (59) (42) (73) (58)
Parasite Metazoan 1 (2%) 4 (5%)
Intestine Small, Duodenum (60) (42) (70) (55)
Mucosa, Hyperplasia, Diffuse 1 (1%)
Intestine Small, Jejunum (59) (41) (69) (56)
Congestion 1 (1%)
Necrosis, Focal 1 (2%)
Mucosa, Hyperplasia, Focal 1 (1%)
Liver (60) (45) (74) (60)
Basophilic Focus 42 (70%) 29 (64%) 48 (65%) 49 (82%)
Clear Cell Focus 19 (32%) 11 (24%) 16 (22%) 28 (47%)
Degeneration, Cystic 7 (12%) 21 (47%) 28 (38%) 15 (25%)
Degeneration, Cystic, Focal 6 (10%) 1 (2%) 4 (5%) 4 (7%)
Degeneration, Cystic, Multifocal 1 (2%) 2 (3%) 9 (15%)
Ectasia, Multifocal 1 (2%) 1 (1%)
Eosinophilic Focus 6 (10%) 15 (33%) 35 (47%) 38 (63%)
Fatty Change 2 (3%) 4 (5%) 3 (5%)
Granuloma 2 (3%) 2 (4%) 3 (5%)
Hematopoietic Cell Proliferation 2 (3%) 15 (33%) 39 (53%) 41 (68%)
Hepatodiaphragmatic Nodule 4 (7%) 3 (7%) 2 (3%) 2 (3%)
Hepatodiaphragmatic Nodule, Multiple 1 (2%)
Infarct, Chronic 1 (2%) 2 (4%)
Necrosis, Coagulative 1 (2%) 1 (1%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Necrosis, Focal 1 (2%) 2 (3%) 5 (8%)
Necrosis, Multifocal 5 (7%) 5 (8%)
Regeneration, Diffuse 1 (2%) 8 (11%) 3 (5%)
Regeneration, Focal 4 (7%) 1 (2%) 3 (4%) 5 (8%)
Regeneration, Multifocal 1 (2%) 5 (11%) 11 (15%) 10 (17%)
Thrombosis 3 (7%) 3 (4%) 7 (12%)
Vacuolization Cytoplasmic, Focal 3 (5%)
Vacuolization Cytoplasmic, Multifocal 2 (3%) 2 (4%) 7 (9%) 7 (12%)
Bile Duct, Hyperplasia 14 (23%) 2 (4%) 6 (8%) 4 (7%)
Caudate Lobe, Pigmentation 1 (1%)
Caudate Lobe, Regeneration 1 (1%)
Centrilobular, Degeneration, Diffuse 4 (9%) 9 (12%) 10 (17%)
Centrilobular, Necrosis 2 (3%) 3 (7%) 4 (5%) 1 (2%)
Centrilobular, Necrosis, Diffuse 2 (3%) 7 (16%) 6 (8%) 5 (8%)
Centrilobular, Necrosis, Focal 1 (2%)
Centrilobular, Necrosis, Multifocal 2 (4%)
Periportal, Fibrosis 1 (1%) 1 (2%)
Serosa, Hemorrhage 1 (2%)
Serosa, Inflammation, Acute 1 (2%)
Mesentery (22) (9) (28) (11)
Ectasia, Focal 1 (4%)
Inflammation, Acute 1 (9%)
Artery, Inflammation, Chronic 1 (5%)
Artery, Mineralization 1 (11%)
Fat, Necrosis 17 (77%) 8 (89%) 21 (75%) 9 (82%)
Vein, Ectasia 1 (4%)
Pancreas (60) (44) (75) (60)
Atrophy 9 (15%) 4 (9%) 5 (7%) 2 (3%)
Degeneration 1 (2%)
Acinus, Hypertrophy, Multifocal 1 (2%)
Pharynx (1) (4) (7) (7)
Palate, Hyperplasia, Focal, Squamous 1 (14%)
Palate, Hyperplasia, Squamous 1 (14%)
Palate, Necrosis 1 (100%)
Salivary Glands (60) (44) (75) (60)
Atrophy 1 (2%)
Interlobular, Edema 1 (2%) 1 (2%)
Parotid Gland, Atrophy 1 (2%)
Stomach, Forestomach (59) (44) (73) (57)
Acanthosis 2 (3%) 2 (3%) 2 (4%)
Acanthosis, Diffuse 1 (2%)
Ulcer 1 (2%) 2 (4%)
Ulcer, Multifocal 1 (2%)
Stomach, Glandular (58) (44) (72) (58)
Erosion, Focal 1 (2%) 2 (3%)
Erosion, Multifocal 5 (11%) 4 (6%)
Hemorrhage, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hemorrhage, Multifocal 1 (1%)
Mineralization 1 (1%)
Necrosis, Focal 1 (2%)
Mucosa, Muscularis, Mineralization 1 (2%)
Submucosa, Hemorrhage, Focal 1 (2%)
Tongue (2) (4) (6) (10)
Hyperkeratosis, Focal 1 (10%)
Necrosis, Focal 1 (17%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (44) (75) (60)
Cardiomyopathy, Chronic 47 (78%) 29 (66%) 58 (77%) 42 (70%)
Inflammation, Acute, Multifocal 1 (1%) 1 (2%)
Mineralization, Multifocal 1 (2%)
Artery, Mineralization 1 (2%)
Atrium, Thrombosis 3 (5%) 15 (34%) 27 (36%) 23 (38%)
Epicardium, Inflammation, Chronic Active,
Focal 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (60) (44) (74) (60)
Angiectasis, Multifocal 1 (2%)
Atrophy 1 (1%)
Congestion 1 (2%)
Hyperplasia, Focal 3 (5%) 1 (2%) 1 (1%)
Infarct, Chronic 1 (2%)
Necrosis, Multifocal 1 (1%)
Pigmentation 1 (1%)
Vacuolization Cytoplasmic, Diffuse 1 (1%) 4 (7%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Vacuolization Cytoplasmic, Multifocal 2 (3%)
Adrenal Gland, Medulla (60) (44) (74) (60)
Atrophy 1 (1%)
Congestion 1 (2%)
Hyperplasia 2 (3%)
Hyperplasia, Focal 4 (7%) 4 (9%) 8 (11%) 5 (8%)
Hyperplasia, Multifocal 1 (2%) 4 (5%) 5 (8%)
Infarct, Chronic 1 (2%)
Pigmentation 1 (1%)
Islets, Pancreatic (60) (44) (75) (60)
Hyperplasia, Focal 2 (3%)
Parathyroid Gland (60) (43) (74) (60)
Hyperplasia 4 (9%) 3 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pituitary Gland (58) (43) (74) (59)
Pigmentation 1 (2%)
Pars Distalis, Angiectasis 1 (1%)
Pars Distalis, Congestion 1 (1%)
Pars Distalis, Cyst 2 (5%) 1 (1%) 1 (2%)
Pars Distalis, Ectasia, Focal 2 (3%)
Pars Distalis, Hyperplasia, Focal 1 (2%) 1 (1%)
Pars Intermedia, Cyst 1 (2%)
Thyroid Gland (60) (44) (74) (60)
C-Cell, Hyperplasia, Focal 6 (10%) 4 (9%) 2 (3%) 2 (3%)
C-Cell, Hyperplasia, Multifocal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (45) (75) (59)
Atypia Cellular 1 (1%)
Preputial Gland (60) (43) (73) (59)
Atrophy 4 (7%) 8 (19%) 10 (14%) 7 (12%)
Cyst 1 (1%)
Ectasia 5 (8%) 12 (28%) 25 (34%) 24 (41%)
Hyperplasia 1 (2%)
Hyperplasia, Focal 1 (2%) 2 (5%) 4 (5%) 8 (14%)
Hyperplasia, Focal, Squamous 3 (7%) 5 (7%) 4 (7%)
Hyperplasia, Multifocal, Squamous 1 (1%)
Hyperplasia, Squamous 1 (2%) 1 (2%)
Inflammation, Acute 2 (3%) 1 (2%)
Inflammation, Chronic 1 (1%) 1 (2%)
Inflammation, Chronic Active 2 (3%)
Prostate (60) (44) (75) (60)
Hyperplasia, Focal, Glandular 5 (8%) 2 (5%) 2 (3%) 2 (3%)
Hyperplasia, Glandular, Multifocal 5 (8%) 4 (9%) 3 (4%)
Inflammation, Acute 2 (3%)
Inflammation, Chronic 1 (1%)
Inflammation, Chronic Active 5 (8%) 2 (5%) 11 (15%) 11 (18%)
Seminal Vesicle (58) (42) (58) (44)
Atrophy 1 (2%) 2 (5%)
Inflammation, Chronic Active 1 (2%)
Bilateral, Atrophy 1 (2%)
Epithelium, Hyperplasia, Focal 1 (2%)
Testes (60) (45) (75) (59)
Atrophy 3 (5%) 4 (9%) 2 (3%) 4 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cyst 1 (1%)
Degeneration 1 (1%) 2 (3%)
Interstitial Cell, Hyperplasia 2 (3%) 4 (9%) 14 (19%) 17 (29%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (43) (74) (60)
Hyperplasia 2 (3%) 3 (7%) 14 (19%) 7 (12%)
Hypoplasia 1 (1%)
Myelofibrosis 3 (5%)
Myelofibrosis, Focal 1 (2%) 2 (3%) 2 (3%)
Myeloid Cell, Hyperplasia 1 (2%)
Lymph Node (60) (43) (75) (58)
Axillary, Congestion 1 (2%)
Axillary, Erythrophagocytosis 1 (2%)
Axillary, Hemorrhage 1 (1%)
Axillary, Hyperplasia, Lymphoid 1 (1%)
Bronchial, Congestion 1 (2%)
Iliac, Hyperplasia, Lymphoid 1 (1%)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Inguinal, Necrosis 1 (1%)
Mediastinal, Atrophy 2 (3%)
Mediastinal, Congestion 3 (7%) 3 (4%) 1 (2%)
Mediastinal, Hemorrhage 2 (3%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%) 2 (3%) 3 (5%)
Mediastinal, Pigmentation 1 (2%) 2 (3%) 1 (2%)
Pancreatic, Congestion 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 1 (2%)
Pancreatic, Hyperplasia, Reticulum Cell 1 (2%)
Lymph Node, Mandibular (60) (43) (74) (58)
Congestion 1 (2%) 2 (3%) 1 (2%)
Erythrophagocytosis 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (1%) 6 (10%)
Hyperplasia, Reticulum Cell 1 (1%)
Lymph Node, Mesenteric (59) (42) (73) (56)
Congestion 1 (2%) 1 (2%)
Ectasia 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 2 (3%) 3 (5%)
Hyperplasia, Reticulum Cell 3 (7%) 6 (8%) 6 (11%)
Spleen (60) (42) (74) (59)
Angiectasis, Focal 2 (3%)
Atrophy 3 (5%) 4 (5%) 4 (7%)
Hematopoietic Cell Proliferation 3 (5%) 13 (31%) 43 (58%) 38 (64%)
Hyperplasia, Megakaryocyte 1 (2%)
Hyperplasia, Reticulum Cell 2 (3%) 4 (5%) 7 (12%)
Metaplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Necrosis 1 (1%)
Necrosis, Multifocal 1 (2%)
Pigmentation, Hemosiderin 1 (1%)
Thymus (53) (34) (55) (48)
Atrophy 1 (2%) 1 (2%)
Edema 1 (2%)
Hemorrhage 1 (2%)
Epithelial Cell, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (45) (75) (60)
Abscess 1 (2%) 1 (1%)
Acanthosis, Focal 1 (1%) 1 (2%)
Acanthosis, Multifocal 1 (2%)
Cyst Epithelial Inclusion 2 (3%) 2 (4%) 1 (1%)
Granuloma, Focal 1 (1%)
Hyperkeratosis, Focal 1 (2%) 2 (3%)
Inflammation, Chronic, Focal 1 (2%)
Necrosis 1 (2%)
Dermis, Fibrosis 1 (2%)
Dermis, Fibrosis, Focal 2 (3%) 1 (2%)
Hair Follicle, Hyperplasia, Basal Cell, Focal 1 (2%) 1 (1%) 3 (5%)
Prepuce, Hemorrhage 1 (2%)
Subcutaneous Tissue, Edema 3 (7%) 3 (4%) 3 (5%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (3) (1) (6)
Cranium, Proliferation, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (44) (75) (60)
Cerebellum, Hemorrhage 1 (2%)
Cerebrum, Hemorrhage 2 (3%)
Cerebrum, Thrombosis, Multifocal 1 (1%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (44) (75) (60)
Congestion 1 (2%) 1 (1%) 1 (2%)
Edema 1 (1%)
Foreign Body 2 (3%) 1 (2%)
Hemorrhage 1 (1%) 1 (2%)
Hyperplasia, Lymphoid 49 (82%) 29 (66%) 55 (73%) 52 (87%)
Infiltration Cellular, Histiocyte 3 (7%) 10 (13%) 6 (10%)
Inflammation, Acute, Multifocal 1 (2%)
Inflammation, Suppurative 1 (2%)
Pigmentation, Focal 1 (1%)
Thrombosis 1 (2%)
Thrombosis, Multiple 1 (2%) 2 (3%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%) 6 (8%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Multifocal 1 (2%) 3 (4%) 3 (5%)
Artery, Mediastinum, Mineralization 1 (2%)
Mediastinum, Inflammation, Acute 1 (2%)
Nose (60) (44) (74) (60)
Foreign Body 1 (2%) 1 (2%)
Fungus 4 (7%) 3 (7%) 9 (12%) 7 (12%)
Hyperkeratosis 2 (3%) 2 (3%) 1 (2%)
Inflammation, Acute 6 (10%) 3 (7%) 8 (11%) 4 (7%)
Inflammation, Chronic 1 (2%) 2 (3%) 3 (5%)
Necrosis, Focal 1 (2%) 2 (3%) 2 (3%)
Necrosis, Multifocal 1 (1%)
Glands, Hyperplasia 1 (2%)
Mucosa, Hyperplasia 1 (1%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%)
Submucosa, Fibrosis 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2)
Canal, Hyperplasia, Focal, Squamous 1 (50%)
Eye (4) (3) (3) (2)
Cataract 1 (25%) 2 (67%)
Degeneration 1 (25%)
Anterior Chamber, Cornea, Inflammation, Acute 1 (33%)
Cornea, Inflammation, Chronic 1 (50%)
Retina, Degeneration 3 (75%) 3 (100%)
Zymbal's Gland (59) (45) (75) (60)
Ectasia 42 (71%) 40 (89%) 53 (71%) 40 (67%)
Ectasia, Focal 1 (1%)
Hyperplasia, Diffuse 2 (4%)
Hyperplasia, Focal 3 (7%) 2 (3%) 2 (3%)
Hyperplasia, Focal, Squamous 4 (9%) 10 (13%) 12 (20%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05172-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 06:28:48
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 80 PPM 170 PPM 330 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Hyperplasia, Multifocal 1 (2%)
Hyperplasia, Squamous 1 (1%)
Hypertrophy, Diffuse 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (44) (74) (60)
Abscess, Multifocal 1 (2%)
Hydronephrosis 1 (1%)
Infarct, Acute 1 (2%)
Infarct, Chronic 1 (2%)
Mineralization 1 (2%)
Nephropathy, Chronic 53 (88%) 36 (82%) 58 (78%) 52 (87%)
Thrombosis, Multifocal 2 (3%)
Cortex, Infarct, Acute 1 (1%)
Proximal Convoluted Renal Tubule, Necrosis,
Diffuse 1 (2%) 1 (1%)
Renal Tubule, Degeneration 1 (2%)
Renal Tubule, Mineralization 2 (3%)
Renal Tubule, Necrosis, Focal 2 (3%)
Renal Tubule, Pigmentation 1 (2%) 1 (2%) 2 (3%) 3 (5%)
Transitional Epithelium, Hyperplasia, Focal 1 (1%) 1 (2%)
Urethra (1)
Hyperplasia, Focal, Squamous 1 (100%)
Urinary Bladder (60) (44) (75) (59)
Edema 1 (2%)
Hemorrhage 3 (4%)
Inflammation, Acute 3 (4%)
Necrosis, Diffuse 2 (3%)
Necrosis, Focal 1 (1%)
Mucosa, Hyperplasia 2 (3%)
Serosa, Cyst 1 (1%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
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