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 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------ --multipart-boundary Content-type: text/plain Range: bytes 101425-101425/101425 --multipart-boundary--