TR 341 Rat Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
NITROFURANTOIN
NTP Experiment-Test: 05051-01 Report: PEIRPT03
Study Type: CHRONIC Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
Facility: Southern Research Institute
Chemical CAS #: 67-20-9
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: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.06% 0.13%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund 22 12 17
Dead 3 12 2
Survivors
Terminal Sacrifice 25 26 31
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (48) (48)
Parasite Metazoan 1 (2%) 1 (2%)
Submucosa, Edema, Diffuse 1 (2%)
Submucosa, Hemorrhage, Multifocal 1 (2%)
Submucosa, Inflammation, Diffuse 1 (2%)
Intestine Large, Colon (50) (46) (48)
Parasite Metazoan 6 (12%) 3 (7%) 2 (4%)
Mucosa, Mineralization 1 (2%)
Intestine Large, Rectum (50) (47) (47)
Parasite Metazoan 1 (2%)
Liver (50) (50) (50)
Angiectasis, Focal 1 (2%)
Basophilic Focus, Multiple 10 (20%) 8 (16%) 10 (20%)
Clear Cell Focus 1 (2%) 1 (2%)
Cytologic Alterations, Focal 1 (2%) 1 (2%)
Developmental Malformation 2 (4%) 4 (8%) 1 (2%)
Focal Cellular Change 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Focal 1 (2%)
Infiltration Cellular, Multifocal, Lymphocyte 2 (4%) 1 (2%)
Inflammation, Focal, Granulomatous 2 (4%) 2 (4%)
Inflammation, Granulomatous, Multifocal 2 (4%) 5 (10%) 7 (14%)
Necrosis, Coagulative, Diffuse 1 (2%)
Necrosis, Coagulative, Focal 2 (4%) 2 (4%)
Vacuolization Cytoplasmic, Diffuse 5 (10%) 2 (4%)
Vacuolization Cytoplasmic, Focal 3 (6%) 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Multifocal 2 (4%) 2 (4%) 1 (2%)
Bile Duct, Hyperplasia 1 (2%) 7 (14%) 4 (8%)
Centrilobular, Congestion 1 (2%)
Kupffer Cell, Pigmentation, Bile 1 (2%)
Mesentery (8) (9) (10)
Hemorrhage, Focal 1 (10%)
Infiltration Cellular, Lymphocyte 1 (11%)
Inflammation, Focal, Granulomatous 1 (11%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.06% 0.13%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fat, Fibrosis, Focal 1 (10%)
Fat, Necrosis, Focal 6 (75%) 7 (78%) 8 (80%)
Pancreas (50) (48) (49)
Acinus, Atrophy 1 (2%)
Acinus, Atrophy, Focal 5 (10%) 5 (10%) 8 (16%)
Acinus, Atrophy, Multifocal 1 (2%)
Acinus, Hyperplasia, Focal 2 (4%) 1 (2%)
Duct, Cyst 1 (2%)
Pharynx (1)
Hyperplasia 1 (100%)
Inflammation, Suppurative 1 (100%)
Stomach, Forestomach (50) (48) (50)
Cyst 1 (2%)
Edema 3 (6%) 3 (6%) 2 (4%)
Hyperkeratosis 2 (4%) 1 (2%)
Hyperplasia 2 (4%)
Inflammation, Chronic 1 (2%) 1 (2%)
Mineralization 1 (2%)
Ulcer, Focal 3 (6%) 3 (6%) 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Stomach, Glandular (50) (48) (50)
Dysplasia, Focal 1 (2%)
Erosion 1 (2%) 2 (4%)
Inflammation, Chronic 1 (2%) 1 (2%)
Mineralization 2 (4%) 3 (6%)
Necrosis, Focal 1 (2%)
Ulcer 1 (2%)
Tongue (1)
Inflammation 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50)
Fibrosis, Multifocal 33 (66%) 34 (68%) 25 (50%)
Inflammation, Multifocal 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (49) (50)
Angiectasis 6 (12%) 5 (10%) 1 (2%)
Congestion 1 (2%)
Cyst 1 (2%)
Degeneration, Fatty, Focal 2 (4%) 5 (10%) 7 (14%)
Hemorrhage, Diffuse 1 (2%)
Hemorrhage, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.06% 0.13%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia, Focal 3 (6%) 3 (6%) 6 (12%)
Hypertrophy, Focal 1 (2%)
Necrosis 2 (4%)
Vacuolization Cytoplasmic, Diffuse 1 (2%)
Vacuolization Cytoplasmic, Focal 4 (8%) 2 (4%)
Extra Adrenal Tissue, Accessory Adrenal
Cortical Nodule 1 (2%)
Adrenal Gland, Medulla (48) (48) (50)
Angiectasis 1 (2%) 1 (2%) 1 (2%)
Cyst, Multiple 1 (2%)
Hyperplasia, Focal 2 (4%) 1 (2%)
Infiltration Cellular, Multifocal, Lymphocyte 1 (2%)
Parathyroid Gland (49) (50) (47)
Hyperplasia 1 (2%)
Pituitary Gland (50) (48) (48)
Pars Distalis, Angiectasis 26 (52%) 24 (50%) 26 (54%)
Pars Distalis, Cyst 8 (16%) 8 (17%) 4 (8%)
Pars Distalis, Cyst, Multiple 5 (10%) 1 (2%) 3 (6%)
Pars Distalis, Hemorrhage 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 2 (4%) 7 (15%) 5 (10%)
Pars Distalis, Necrosis 1 (2%)
Pars Distalis, Pigmentation 1 (2%)
Thyroid Gland (50) (50) (50)
Ultimobranchial Cyst 1 (2%) 3 (6%)
C-Cell, Hyperplasia, Focal 5 (10%) 9 (18%) 4 (8%)
C-Cell, Hyperplasia, Multifocal 3 (6%) 5 (10%) 2 (4%)
Follicle, Cyst 1 (2%)
Follicle, Hyperplasia, Cystic 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (3) (1)
Hemorrhage 1 (33%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (44) (38) (42)
Inflammation, Suppurative 2 (5%) 5 (13%) 1 (2%)
Duct, Cyst 12 (27%) 13 (34%) 7 (17%)
Ovary (50) (50) (50)
Cyst 2 (4%) 1 (2%)
Uterus (50) (50) (50)
Hemorrhage, Chronic, Focal 1 (2%)
Hydrometra 2 (4%) 2 (4%)
Cervix, Abscess 4 (8%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.06% 0.13%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Cervix, Cyst 2 (4%) 5 (10%) 1 (2%)
Cervix, Cyst, Multiple 1 (2%)
Cervix, Inflammation, Suppurative 1 (2%) 4 (8%) 3 (6%)
Endometrium, Cyst 1 (2%)
Endometrium, Hyperplasia, Cystic 5 (10%) 10 (20%) 10 (20%)
Endometrium, Inflammation, Suppurative 2 (4%) 1 (2%)
Endometrium, Necrosis, Focal 1 (2%)
Lumen, Inflammation, Suppurative 1 (2%)
Muscularis, Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (9) (2) (8)
Anemia 1 (11%)
Anisocytosis 1 (13%)
Bone Marrow (49) (48) (50)
Hyperplasia, Reticulum Cell 1 (2%) 2 (4%)
Myelofibrosis 2 (4%) 1 (2%)
Myeloid Cell, Hyperplasia 2 (4%) 4 (8%)
Lymph Node (50) (50) (50)
Axillary, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Axillary, Infiltration Cellular, Plasma Cell 1 (2%)
Axillary, Infiltration Cellular, Histiocyte 1 (2%)
Iliac, Hyperplasia, Lymphoid 1 (2%)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Congestion 1 (2%) 1 (2%)
Mediastinal, Erythrophagocytosis 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%)
Renal, Sinus, Ectasia 1 (2%)
Lymph Node, Mandibular (48) (47) (50)
Erythrophagocytosis 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%) 1 (2%)
Infiltration Cellular, Plasma Cell 2 (4%)
Inflammation, Suppurative 1 (2%)
Lymph Node, Mesenteric (50) (48) (49)
Angiectasis 1 (2%) 1 (2%)
Erythrophagocytosis 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Spleen (50) (49) (50)
Atrophy 1 (2%)
Congestion 1 (2%) 4 (8%) 2 (4%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 4 (8%) 6 (12%) 8 (16%)
Hemorrhage 1 (2%)
Hyperplasia, Focal, Lymphoid 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.06% 0.13%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Necrosis, Coagulative 1 (2%)
Pigmentation, Hemosiderin 1 (2%) 1 (2%) 1 (2%)
Thymus (43) (34) (40)
Congestion 1 (3%)
Hyperplasia, Lymphoid 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (50) (50)
Hyperplasia, Cystic 5 (10%) 19 (38%) 11 (22%)
Hyperplasia, Lobular 5 (10%) 5 (10%) 3 (6%)
Duct, Cyst 38 (78%) 33 (66%) 39 (78%)
Skin (50) (49) (50)
Cyst Epithelial Inclusion 1 (2%) 1 (2%)
Hyperkeratosis, Focal 2 (4%) 1 (2%)
Hyperplasia, Focal 1 (2%)
Subcutaneous Tissue, Cyst 1 (2%)
Subcutaneous Tissue, Inflammation,
Suppurative 2 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Osteopetrosis 1 (2%)
Cranium, Hyperostosis 4 (8%) 4 (8%) 5 (10%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Compression 6 (12%) 2 (4%) 1 (2%)
Degeneration, Multifocal 1 (2%) 1 (2%) 3 (6%)
Hemorrhage, Focal 1 (2%)
Hemorrhage, Multifocal 1 (2%) 1 (2%)
Hydrocephalus 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Angiectasis 2 (4%)
Congestion 1 (2%) 4 (8%) 4 (8%)
Edema 1 (2%)
Infiltration Cellular, Focal, Histiocyte 2 (4%) 3 (6%) 5 (10%)
Infiltration Cellular, Multifocal, Lymphocyte 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.06% 0.13%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Inflammation, Chronic 4 (8%) 2 (4%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 2 (4%)
Alveolar Epithelium, Hyperplasia, Multifocal 1 (2%)
Bronchiole, Inflammation, Chronic Active 1 (2%)
Bronchiole, Inflammation, Suppurative 1 (2%)
Interstitium, Edema 2 (4%)
Nose (50) (49) (47)
Lumen, Foreign Body 1 (2%) 1 (2%) 1 (2%)
Lumen, Fungus 2 (4%) 1 (2%)
Lumen, Inflammation, Suppurative 4 (8%) 1 (2%) 3 (6%)
Nasolacrimal Duct, Inflammation, Suppurative 5 (10%) 4 (9%)
Trachea (50) (50) (50)
Infiltration Cellular, Lymphocyte 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (11) (18) (5)
Middle Ear, Inflammation, Suppurative 1 (9%)
Eye (1) (19) (6)
Cataract 16 (84%) 2 (33%)
Inflammation, Suppurative 1 (100%) 1 (5%)
Synechia 1 (17%)
Cornea, Edema 2 (33%)
Lens, Mineralization 2 (11%)
Retina, Degeneration 17 (89%) 3 (50%)
Harderian Gland (1) (9)
Fibrosis 1 (100%) 8 (89%)
Infiltration Cellular, Multifocal, Lymphocyte 1 (11%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Mineralization, Multifocal 1 (2%) 1 (2%)
Nephropathy, Chronic 44 (88%) 40 (80%) 48 (96%)
Pigmentation, Hemosiderin 1 (2%)
Cortex, Fibrosis, Focal 1 (2%)
Pelvis, Hydronephrosis 1 (2%)
Pelvis, Infiltration Cellular, Lymphocyte 1 (2%)
Renal Tubule, Degeneration 1 (2%) 2 (4%)
Renal Tubule, Hyperplasia, Focal 1 (2%) 1 (2%)
Renal Tubule, Pigmentation, Hemosiderin 1 (2%) 2 (4%) 2 (4%)
Urinary Bladder (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 0.06% 0.13%
CONTROL
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Mucosa, Hyperplasia, Diffuse 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.13% 0.25%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50
Early Deaths
Moribund 23 22 21
Dead 3 1 3
Survivors
Moribund 1
Terminal Sacrifice 23 27 26
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (50) (50) (48)
Parasite Metazoan 1 (2%) 2 (4%)
Submucosa, Edema 1 (2%) 1 (2%) 3 (6%)
Intestine Large, Colon (50) (50) (48)
Parasite Metazoan 6 (12%) 5 (10%) 2 (4%)
Intestine Large, Rectum (50) (48) (47)
Parasite Metazoan 1 (2%)
Liver (50) (50) (50)
Angiectasis 2 (4%) 2 (4%) 1 (2%)
Basophilic Focus 1 (2%) 1 (2%)
Congestion 2 (4%)
Cytologic Alterations, Focal 5 (10%) 5 (10%) 4 (8%)
Cytologic Alterations, Multifocal 1 (2%) 2 (4%) 2 (4%)
Degeneration, Cystic, Focal 4 (8%) 2 (4%) 2 (4%)
Developmental Malformation 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Nodular 1 (2%) 1 (2%)
Infiltration Cellular, Multifocal, Lymphocyte 1 (2%)
Inflammation, Granulomatous, Multifocal 3 (6%) 4 (8%)
Mixed Cell Focus 1 (2%)
Necrosis, Coagulative, Multifocal 3 (6%) 3 (6%)
Vacuolization Cytoplasmic, Diffuse 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Focal 3 (6%) 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Multifocal 2 (4%)
Bile Duct, Hyperplasia 10 (20%) 15 (30%) 21 (42%)
Bile Duct, Hyperplasia, Multifocal 1 (2%)
Centrilobular, Degeneration 1 (2%)
Portal, Fibrosis 1 (2%) 1 (2%)
Serosa, Fibrosis, Focal 1 (2%)
Mesentery (6) (9) (6)
Fibrosis, Focal 1 (17%)
Inflammation, Granulomatous 1 (17%)
Pigmentation, Hematoidin, Hemosiderin 1 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.13% 0.25%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Artery, Inflammation, Chronic 1 (11%) 1 (17%)
Artery, Mineralization 1 (17%)
Artery, Thrombosis 1 (17%)
Fat, Edema 1 (17%)
Fat, Necrosis, Focal 1 (17%) 5 (56%) 3 (50%)
Vein, Mineralization 1 (11%)
Pancreas (50) (50) (49)
Hyperplasia, Focal 1 (2%)
Pigmentation, Hematoidin, Hemosiderin 1 (2%)
Acinus, Atrophy 9 (18%) 10 (20%) 15 (31%)
Adventitia, Edema 1 (2%) 1 (2%)
Artery, Inflammation, Chronic 2 (4%) 1 (2%)
Salivary Glands (48) (50) (50)
Hyperplasia 1 (2%)
Stomach, Forestomach (49) (50) (49)
Edema 2 (4%) 2 (4%)
Inflammation, Chronic 3 (6%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Mineralization 3 (6%) 3 (6%)
Necrosis 1 (2%)
Ulcer, Focal 1 (2%) 2 (4%)
Stomach, Glandular (49) (50) (50)
Edema 1 (2%)
Mineralization 1 (2%) 8 (16%) 14 (28%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Aorta, Mineralization 1 (100%)
Heart (50) (50) (50)
Fibrosis, Multifocal 44 (88%) 45 (90%) 39 (78%)
Inflammation, Suppurative 1 (2%)
Mineralization, Multifocal 1 (2%)
Atrium, Thrombosis 3 (6%) 3 (6%) 2 (4%)
Valve, Bacterium 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50)
Angiectasis 1 (2%) 1 (2%)
Cyst 1 (2%)
Fibrosis 1 (2%)
Hyperplasia, Focal 3 (6%) 2 (4%)
Hypertrophy, Focal 2 (4%)
Necrosis, Multifocal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.13% 0.25%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Vacuolization Cytoplasmic, Diffuse 1 (2%)
Vacuolization Cytoplasmic, Focal 11 (22%) 6 (12%) 15 (30%)
Vacuolization Cytoplasmic, Multifocal 1 (2%) 2 (4%)
Adrenal Gland, Medulla (50) (50) (50)
Angiectasis 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Focal 10 (20%) 8 (16%) 7 (14%)
Hyperplasia, Multifocal 1 (2%) 2 (4%)
Mineralization 1 (2%) 1 (2%)
Parathyroid Gland (49) (47) (49)
Hyperplasia 3 (6%) 18 (38%) 23 (47%)
Pituitary Gland (50) (50) (50)
Pars Distalis, Angiectasis 9 (18%) 7 (14%) 14 (28%)
Pars Distalis, Cyst 1 (2%) 2 (4%) 3 (6%)
Pars Distalis, Cyst, Multiple 1 (2%) 2 (4%)
Pars Distalis, Hemorrhage 1 (2%)
Pars Distalis, Hyperplasia, Focal 7 (14%) 6 (12%) 5 (10%)
Pars Distalis, Hyperplasia, Multifocal 1 (2%)
Pars Distalis, Necrosis 1 (2%)
Pars Nervosa, Infiltration Cellular 1 (2%)
Thyroid Gland (50) (50) (50)
Ultimobranchial Cyst 1 (2%) 2 (4%)
C-Cell, Hyperplasia, Focal 6 (12%) 2 (4%) 5 (10%)
C-Cell, Hyperplasia, Multifocal 1 (2%) 1 (2%)
Follicle, Cyst 1 (2%) 1 (2%)
Follicle, Cyst, Multiple 1 (2%)
Follicle, Hyperplasia, Cystic 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1) (1)
Hyperplasia 1 (100%)
Inflammation, Chronic 1 (100%)
Inflammation, Suppurative 1 (100%)
Epididymis (50) (50) (50)
Atypia Cellular 12 (24%)
Degeneration 1 (2%)
Depletion Cellular 40 (80%) 43 (86%) 46 (92%)
Fibrosis 1 (2%)
Inflammation, Granulomatous 1 (2%)
Preputial Gland (48) (50) (47)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.13% 0.25%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Atrophy 1 (2%)
Fibrosis 7 (15%) 3 (6%) 5 (11%)
Hyperplasia 1 (2%) 1 (2%)
Inflammation, Suppurative 11 (23%) 6 (12%)
Duct, Cyst 9 (19%) 13 (26%) 3 (6%)
Prostate (50) (50) (49)
Cyst 2 (4%) 2 (4%)
Cyst, Multiple 3 (6%)
Fibrosis 4 (8%)
Inflammation 1 (2%)
Inflammation, Chronic 3 (6%) 2 (4%)
Inflammation, Chronic, Focal 1 (2%)
Inflammation, Suppurative 24 (48%) 19 (38%) 39 (80%)
Mineralization, Focal 1 (2%)
Mineralization, Multifocal 1 (2%)
Epithelium, Hyperplasia 1 (2%) 1 (2%)
Seminal Vesicle (50) (50) (50)
Atrophy 1 (2%) 8 (16%) 8 (16%)
Dilatation 1 (2%)
Fibrosis 1 (2%)
Mineralization 1 (2%)
Epithelium, Hyperplasia 4 (8%)
Testes (50) (50) (50)
Aspermatogenesis 38 (76%) 40 (80%) 44 (88%)
Atrophy 41 (82%) 44 (88%) 48 (96%)
Degeneration 36 (72%)
Hemorrhage 1 (2%)
Mineralization 1 (2%)
Arteriole, Necrosis, Fibrinoid 1 (2%) 8 (16%) 15 (30%)
Interstitial Cell, Hyperplasia 4 (8%) 3 (6%) 2 (4%)
Perivascular, Infiltration Cellular,
Mononuclear Cell 3 (6%) 9 (18%) 19 (38%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (18) (13) (10)
Anemia 1 (8%)
Hypochromasia 1 (6%)
Polychromasia 1 (6%) 1 (8%) 1 (10%)
Bone Marrow (50) (50) (50)
Atrophy 1 (2%)
Hyperplasia, Reticulum Cell 2 (4%)
Myelofibrosis 1 (2%) 2 (4%)
Myeloid Cell, Hyperplasia 1 (2%) 2 (4%)
Lymph Node (50) (50) (50)
Inguinal, Hyperplasia, Lymphoid 1 (2%) 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.13% 0.25%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Mediastinal, Angiectasis 2 (4%)
Mediastinal, Congestion 1 (2%) 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%) 2 (4%)
Mediastinal, Pigmentation, Hemosiderin 1 (2%)
Pancreatic, Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Pancreatic, Inflammation, Granulomatous 1 (2%)
Pancreatic, Mineralization 1 (2%)
Renal, Angiectasis 4 (8%)
Renal, Hyperplasia, Lymphoid 1 (2%) 3 (6%)
Lymph Node, Mandibular (46) (50) (47)
Angiectasis 1 (2%) 1 (2%)
Cyst 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 4 (9%) 2 (4%) 10 (21%)
Infiltration Cellular, Plasma Cell 1 (2%)
Lymph Node, Mesenteric (49) (48) (49)
Angiectasis 3 (6%) 3 (6%)
Ectasia 2 (4%)
Hyperplasia, Lymphoid 3 (6%) 4 (8%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
Spleen (50) (50) (50)
Congestion 4 (8%) 4 (8%)
Fibrosis 1 (2%)
Fibrosis, Diffuse 1 (2%)
Fibrosis, Focal 1 (2%) 2 (4%) 6 (12%)
Hematopoietic Cell Proliferation 3 (6%) 1 (2%) 2 (4%)
Hyperplasia, Lymphoid 2 (4%)
Necrosis 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Thymus (40) (36) (34)
Artery, Inflammation 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (49) (46)
Duct, Cyst 6 (13%) 11 (22%) 7 (15%)
Skin (50) (50) (50)
Alopecia 2 (4%)
Cyst Epithelial Inclusion 2 (4%) 3 (6%)
Fibrosis, Focal 3 (6%) 1 (2%)
Hyperkeratosis, Focal 2 (4%) 2 (4%)
Hyperplasia, Focal 1 (2%) 2 (4%)
Inflammation, Chronic 2 (4%)
Ulcer, Focal 1 (2%) 1 (2%)
Prepuce, Ulcer 1 (2%)
Subcutaneous Tissue, Mineralization, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.13% 0.25%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Subcutaneous Tissue, Necrosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50)
Fibrous Osteodystrophy 5 (10%) 5 (10%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50)
Compression 1 (2%) 2 (4%) 2 (4%)
Cerebellum, Degeneration 1 (2%)
Cerebellum, Hemorrhage, Acute, Multifocal 1 (2%)
Cerebellum, Hemorrhage, Focal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50)
Atelectasis 1 (2%) 2 (4%)
Congestion 2 (4%) 2 (4%) 3 (6%)
Hemorrhage, Multifocal 1 (2%) 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Infiltration Cellular, Histiocyte 3 (6%) 8 (16%) 2 (4%)
Inflammation, Suppurative 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 3 (6%)
Alveolar Epithelium, Hyperplasia, Multifocal 1 (2%)
Alveolus, Edema 1 (2%) 1 (2%)
Alveolus, Mineralization, Multifocal 1 (2%)
Arteriole, Hypertrophy 1 (2%)
Bronchiole, Foreign Body 1 (2%)
Interstitium, Edema 1 (2%)
Interstitium, Infiltration Cellular, Diffuse,
Histiocyte 1 (2%)
Interstitium, Infiltration Cellular,
Mononuclear Cell 1 (2%)
Mediastinum, Pigmentation, Hemosiderin 1 (2%)
Nose (50) (49) (48)
Lumen, Foreign Body 1 (2%)
Lumen, Fungus 2 (4%)
Lumen, Inflammation, Suppurative 3 (6%) 1 (2%) 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) 4 (8%) 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05051-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC NITROFURANTOIN Date: 09/07/94
Route: DOSED FEED Time: 06:59:56
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 0.13% 0.25%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (4) (6) (22)
Cataract 1 (25%) 14 (64%)
Anterior Chamber, Hemorrhage 1 (5%)
Anterior Chamber, Inflammation, Suppurative 1 (17%) 1 (5%)
Cornea, Infiltration Cellular, Lymphocyte 1 (17%)
Cornea, Inflammation, Focal, Granulomatous 1 (5%)
Cornea, Mineralization 1 (17%)
Lens, Mineralization 2 (9%)
Retina, Degeneration 2 (50%) 17 (77%)
Harderian Gland (1) (5) (4)
Atrophy 1 (25%)
Ectasia 2 (40%)
Fibrosis 1 (100%) 3 (60%) 4 (100%)
Lacrimal Gland (1)
Atrophy 1 (100%)
Inflammation, Chronic 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Embolus Bacterial, Multifocal 1 (2%)
Infiltration Cellular, Multifocal, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Mineralization 2 (4%) 3 (6%)
Nephropathy, Chronic 50 (100%) 48 (96%) 48 (96%)
Cortex, Cyst 2 (4%) 2 (4%) 2 (4%)
Cortex, Cyst, Multiple 3 (6%) 1 (2%)
Cortex, Necrosis 1 (2%)
Medulla, Congestion 1 (2%)
Pelvis, Hydronephrosis 5 (10%) 2 (4%)
Pelvis, Transitional Epithelium, Hyperplasia 5 (10%) 2 (4%)
Renal Tubule, Hyperplasia, Focal 2 (4%) 2 (4%) 1 (2%)
Renal Tubule, Pigmentation, Hemosiderin 1 (2%) 1 (2%)
Ureter (1)
Dilatation 1 (100%)
Urinary Bladder (50) (50) (50)
Mucosa, Hyperplasia 1 (2%) 2 (4%)
Mucosa, Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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