TDMS Study 05182-03 Pathology Tables
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
Facility: TSI Mason Research
Chemical CAS #: 77-09-8
Lock Date: 01/24/94
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: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 9 8 7 8
Natural Death 11 4 11 4
Survivors
Terminal Sacrifice 30 38 32 38
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (48) (49) (49) (49)
Parasite Metazoan 1 (2%) 2 (4%) 2 (4%) 2 (4%)
Intestine Large, Rectum (49) (47) (48) (49)
Edema 1 (2%)
Inflammation, Acute 1 (2%)
Parasite Metazoan 4 (8%)
Intestine Large, Cecum (45) (49) (47) (48)
Edema 1 (2%) 3 (6%)
Necrosis 1 (2%)
Intestine Small, Duodenum (46) (49) (49) (48)
Inflammation, Chronic 1 (2%)
Intestine Small, Jejunum (44) (49) (47) (48)
Ulcer, Focal 1 (2%)
Intestine Small, Ileum (47) (49) (45) (49)
Necrosis 1 (2%)
Ulcer, Focal 1 (2%)
Liver (50) (50) (50) (49)
Angiectasis, Focal 1 (2%) 4 (8%) 4 (8%)
Basophilic Focus 32 (64%) 34 (68%) 34 (68%) 34 (69%)
Clear Cell Focus 2 (4%) 3 (6%) 3 (6%) 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%)
Eosinophilic Focus 12 (24%) 12 (24%) 12 (24%) 4 (8%)
Fibrosis, Focal 1 (2%)
Hematopoietic Cell Proliferation 3 (6%) 2 (4%) 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 3 (6%) 7 (14%) 6 (12%) 4 (8%)
Hyperplasia, Focal 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Inflammation, Chronic 7 (14%) 3 (6%) 4 (8%) 4 (8%)
Mixed Cell Focus 25 (50%) 23 (46%) 31 (62%) 33 (67%)
Necrosis 2 (4%) 1 (2%)
Bile Duct, Hyperplasia, Focal 1 (2%)
Centrilobular, Necrosis 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 3 (6%) 1 (2%) 3 (6%) 6 (12%)
Kupffer Cell, Hyperplasia, Diffuse 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (12) (7) (6) (7)
Accessory Spleen 1 (8%) 1 (14%)
Fat, Necrosis 10 (83%) 7 (100%) 6 (100%) 5 (71%)
Oral Mucosa (3)
Ulcer 1 (33%)
Pancreas (49) (49) (49) (46)
Acinus, Atrophy, Diffuse 4 (8%) 1 (2%) 1 (2%) 2 (4%)
Acinus, Atrophy, Focal 17 (35%) 28 (57%) 30 (61%) 22 (48%)
Acinus, Basophilic Focus 1 (2%)
Acinus, Hyperplasia, Focal 2 (4%) 1 (2%)
Salivary Glands (50) (50) (50) (49)
Atrophy, Diffuse 1 (2%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Parotid Gland, Atrophy, Diffuse 2 (4%)
Parotid Gland, Atrophy, Focal 1 (2%) 2 (4%) 1 (2%)
Submandibular Gland, Atrophy, Diffuse 1 (2%)
Stomach, Forestomach (49) (50) (50) (49)
Inflammation, Chronic 1 (2%) 2 (4%) 1 (2%)
Ulcer, Focal 3 (6%) 1 (2%)
Epithelium, Hyperplasia 4 (8%) 3 (6%) 4 (8%) 2 (4%)
Stomach, Glandular (48) (50) (50) (48)
Erosion, Focal 6 (13%) 2 (4%) 1 (2%) 2 (4%)
Inflammation, Chronic 1 (2%)
Glands, Cyst, Focal 8 (17%) 9 (18%) 21 (42%) 4 (8%)
Serosa, Inflammation, Acute 1 (2%)
Tongue (2) (3) (2)
Capillary, Erosion, Focal 1 (33%) 1 (50%)
Tooth (1) (2)
Developmental Malformation 1 (50%)
Gingiva, Inflammation, Chronic 1 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (50)
Aorta, Media, Mineralization 1 (2%)
Heart (50) (50) (50) (49)
Cardiomyopathy 36 (72%) 32 (64%) 34 (68%) 27 (55%)
Artery, Inflammation, Chronic 1 (2%)
Atrium, Thrombosis 2 (4%)
Myocardium, Inflammation, Acute, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (49) (49)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Focal 2 (4%) 5 (10%) 5 (10%) 6 (12%)
Hypertrophy, Focal 2 (4%) 1 (2%) 3 (6%) 3 (6%)
Inflammation, Acute, Focal 1 (2%)
Pigmentation 1 (2%)
Vacuolization Cytoplasmic, Focal 6 (12%) 17 (34%) 18 (37%) 10 (20%)
Bilateral, Hematopoietic Cell Proliferation 1 (2%)
Bilateral, Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Bilateral, Necrosis 2 (4%) 2 (4%) 1 (2%)
Bilateral, Vacuolization Cytoplasmic, Focal 2 (4%) 1 (2%)
Adrenal Medulla (50) (50) (50) (49)
Hyperplasia, Focal 9 (18%) 14 (28%) 15 (30%) 11 (22%)
Infiltration Cellular, Lymphocyte 1 (2%)
Bilateral, Hyperplasia, Focal 1 (2%) 4 (8%)
Islets, Pancreatic (49) (49) (49) (47)
Metaplasia, Focal 1 (2%) 1 (2%)
Parathyroid Gland (46) (46) (47) (44)
Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%)
Pituitary Gland (50) (49) (50) (47)
Pars Distalis, Angiectasis, Focal 1 (2%) 1 (2%) 1 (2%) 5 (11%)
Pars Distalis, Cyst 14 (28%) 17 (35%) 16 (32%) 11 (23%)
Pars Distalis, Hyperplasia, Focal 5 (10%) 2 (4%) 2 (4%) 4 (9%)
Pars Distalis, Pigmentation 1 (2%) 1 (2%)
Rathke's Cleft, Cyst 1 (2%)
Thyroid Gland (50) (50) (50) (48)
Ultimobranchial Cyst 1 (2%) 2 (4%)
C-Cell, Hyperplasia, Diffuse 1 (2%)
C-Cell, Hyperplasia, Focal 20 (40%) 18 (36%) 17 (34%) 9 (19%)
Follicle, Cyst 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Follicle, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (50) (49) (48)
Cyst 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%) 4 (8%) 4 (8%) 3 (6%)
Inflammation, Chronic 4 (8%) 4 (8%) 8 (16%) 7 (15%)
Inflammation, Chronic Active 3 (6%) 3 (6%) 1 (2%) 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Bilateral, Atrophy 1 (2%) 2 (4%)
Bilateral, Hyperplasia, Focal 1 (2%)
Duct, Hyperplasia, Focal 1 (2%)
Duct, Inflammation, Acute 1 (2%)
Ovary (50) (50) (50) (50)
Cyst 1 (2%)
Bilateral, Atrophy 1 (2%)
Bilateral, Cyst 1 (2%)
Bilateral, Pigmentation 1 (2%)
Bursa, Cyst 1 (2%) 4 (8%) 4 (8%) 6 (12%)
Follicle, Cyst 2 (4%) 2 (4%) 4 (8%)
Periovarian Tissue, Cyst 1 (2%)
Oviduct (1)
Cyst 1 (100%)
Uterus (50) (50) (50) (50)
Hydrometra 4 (8%) 4 (8%) 3 (6%) 6 (12%)
Inflammation, Chronic Active 1 (2%)
Necrosis 1 (2%)
Thrombosis 1 (2%)
Endometrium, Atrophy 1 (2%)
Endometrium, Cyst 1 (2%) 1 (2%) 4 (8%)
Endometrium, Inflammation, Acute 2 (4%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50)
Atrophy 1 (2%) 1 (2%) 3 (6%) 5 (10%)
Hyperplasia 6 (12%) 9 (18%) 4 (8%) 6 (12%)
Myelofibrosis 5 (10%) 1 (2%) 2 (4%) 2 (4%)
Lymph Node (7) (11) (9) (9)
Iliac, Hemorrhage 1 (11%)
Iliac, Hyperplasia, Lymphoid 1 (11%)
Mediastinal, Hemorrhage 1 (14%) 1 (11%)
Mediastinal, Pigmentation 1 (11%)
Renal, Infiltration Cellular, Histiocyte 1 (14%)
Lymph Node, Mandibular (50) (50) (50) (48)
Degeneration, Cystic 6 (12%) 11 (22%) 2 (4%) 8 (17%)
Hemorrhage 2 (4%) 1 (2%)
Hyperplasia, Lymphoid 14 (28%) 4 (8%) 6 (12%) 5 (10%)
Infiltration Cellular, Histiocyte 4 (8%) 3 (6%) 1 (2%) 3 (6%)
Necrosis 1 (2%)
Pigmentation 1 (2%) 1 (2%) 1 (2%)
Lymph Node, Mesenteric (49) (50) (49) (48)
Degeneration, Cystic 2 (4%) 1 (2%) 4 (8%) 1 (2%)
Ectasia 1 (2%)
Hemorrhage 1 (2%) 2 (4%) 2 (4%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Infiltration Cellular, Histiocyte 30 (61%) 33 (66%) 31 (63%) 26 (54%)
Pigmentation 1 (2%)
Spleen (50) (50) (50) (49)
Congestion 1 (2%)
Fibrosis 1 (2%)
Hematopoietic Cell Proliferation 9 (18%) 7 (14%) 6 (12%) 6 (12%)
Pigmentation 8 (16%) 7 (14%) 10 (20%) 6 (12%)
Lymphoid Follicle, Atrophy 3 (6%)
Thymus (50) (49) (49) (48)
Cyst 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Epithelial Cell, Hyperplasia 20 (40%) 34 (69%) 31 (63%) 23 (48%)
Thymocyte, Atrophy 21 (42%) 19 (39%) 20 (41%) 23 (48%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (48) (49)
Galactocele 22 (44%) 15 (30%) 14 (29%) 17 (35%)
Inflammation, Chronic 2 (4%)
Epithelium, Hyperplasia 1 (2%) 1 (2%)
Skin (50) (50) (49) (50)
Subcutaneous Tissue, Fibrosis, Focal 1 (2%)
Subcutaneous Tissue, Inflammation, Acute 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic,
Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Inflammation, Acute 1 (2%)
Femur, Fibrous Osteodystrophy 1 (2%)
Femur, Hyperostosis 7 (14%) 2 (4%) 3 (6%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hydrocephalus 1 (2%) 1 (2%) 5 (10%)
Cerebellum, Hemorrhage, Focal 1 (2%)
Cerebrum, Hemorrhage, Focal 1 (2%) 1 (2%) 1 (2%)
Meninges, Cerebrum, Hemorrhage 1 (2%)
Pons, Hemorrhage, Focal 1 (2%)
Thalamus, Cerebrum, Necrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Peripheral Nerve (1) (2) (2) (2)
Sciatic, Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Foreign Body 1 (2%)
Hemorrhage 2 (4%) 1 (2%) 8 (16%) 4 (8%)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Infiltration Cellular, Focal, Histiocyte 1 (2%)
Inflammation, Chronic Active 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 4 (8%) 5 (10%)
Interstitium, Inflammation, Chronic 6 (12%) 5 (10%) 6 (12%) 6 (12%)
Interstitium, Inflammation, Chronic Active 1 (2%)
Serosa, Inflammation, Chronic 1 (2%)
Nose (50) (49) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 5 (10%) 2 (4%) 2 (4%) 4 (8%)
Inflammation, Chronic Active 1 (2%) 6 (12%) 3 (6%) 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 2 (4%) 2 (4%) 2 (4%)
Nasolacrimal Duct, Inflammation, Chronic 1 (2%)
Nasolacrimal Duct, Inflammation, Chronic
Active 1 (2%)
Olfactory Epithelium, Cytoplasmic Alteration 3 (6%) 6 (12%) 3 (6%) 2 (4%)
Turbinate, Congestion 1 (2%)
Trachea (50) (50) (50) (49)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%) 3 (6%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (1) (2)
Atrophy 1 (100%)
Cornea, Inflammation, Chronic 1 (50%) 1 (50%)
Lens, Cataract 1 (50%) 2 (100%)
Retina, Atrophy 1 (50%) 2 (100%)
Zymbal's Gland (1) (1)
Cyst 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Cyst 2 (4%) 1 (2%)
Ectopic Liver 1 (2%)
Fibrosis, Focal 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Mineralization, Focal 3 (6%) 3 (6%) 5 (10%) 3 (6%)
Nephropathy, Chronic 4 (8%) 1 (2%) 2 (4%)
Bilateral, Mineralization, Focal 7 (14%) 5 (10%) 9 (18%) 5 (10%)
Bilateral, Nephropathy, Chronic 30 (60%) 44 (88%) 43 (86%) 42 (84%)
Bilateral, Pelvis, Dilatation 1 (2%)
Bilateral, Pelvis, Inflammation, Acute 1 (2%)
Bilateral, Pelvis, Inflammation, Chronic
Active 1 (2%)
Bilateral, Pelvis, Mineralization, Focal 1 (2%)
Bilateral, Pelvis, Transitional Epithelium,
Hyperplasia 2 (4%)
Bilateral, Renal Tubule, Accumulation,
Hyaline Droplet 2 (4%)
Bilateral, Renal Tubule, Pigmentation 11 (22%) 9 (18%) 7 (14%) 8 (16%)
Papilla, Necrosis 1 (2%)
Pelvis, Dilatation 1 (2%)
Pelvis, Inflammation, Acute 2 (4%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
Renal Tubule, Degeneration 1 (2%)
Urinary Bladder (49) (49) (49) (49)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 15 15 13 16
Natural Death 14 20 22 21
Survivors
Terminal Sacrifice 21 15 14 13
Natural Death 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (48) (49) (49) (48)
Parasite Metazoan 1 (2%) 2 (4%) 4 (8%) 3 (6%)
Muscularis, Necrosis, Focal 1 (2%)
Intestine Large, Rectum (48) (49) (50) (50)
Necrosis 1 (2%)
Parasite Metazoan 1 (2%) 2 (4%)
Intestine Large, Cecum (44) (41) (44) (40)
Edema 3 (7%) 1 (2%) 1 (3%)
Erosion, Focal 1 (3%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Necrosis 1 (2%) 1 (3%)
Artery, Inflammation, Chronic 2 (5%) 1 (3%)
Epithelium, Hyperplasia 1 (3%)
Intestine Small, Duodenum (47) (50) (49) (47)
Artery, Inflammation, Chronic 1 (2%)
Muscularis, Necrosis, Focal 1 (2%)
Intestine Small, Jejunum (47) (41) (47) (42)
Inflammation, Chronic Active 1 (2%)
Intestine Small, Ileum (44) (40) (40) (41)
Inflammation, Chronic 1 (3%)
Liver (50) (50) (50) (50)
Angiectasis, Focal 7 (14%) 1 (2%) 1 (2%) 1 (2%)
Basophilic Focus 17 (34%) 18 (36%) 9 (18%) 21 (42%)
Clear Cell Focus 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Degeneration, Cystic, Focal 4 (8%) 1 (2%) 6 (12%) 5 (10%)
Eosinophilic Focus 8 (16%) 10 (20%) 7 (14%) 14 (28%)
Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 2 (4%) 1 (2%)
Hepatodiaphragmatic Nodule 4 (8%) 1 (2%) 2 (4%)
Mixed Cell Focus 4 (8%) 8 (16%) 8 (16%)
Necrosis 1 (2%) 5 (10%) 3 (6%)
Bile Duct, Hyperplasia 10 (20%) 1 (2%) 2 (4%) 4 (8%)
Centrilobular, Necrosis 2 (4%) 1 (2%) 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hepatocyte, Vacuolization Cytoplasmic 3 (6%) 12 (24%) 13 (26%) 10 (20%)
Vein, Thrombosis 2 (4%) 1 (2%)
Mesentery (20) (7) (3) (3)
Metaplasia, Osseous 1 (33%)
Polyarteritis 1 (33%)
Artery, Inflammation, Chronic 1 (33%)
Fat, Necrosis 19 (95%) 4 (57%) 1 (33%) 2 (67%)
Pancreas (50) (50) (50) (47)
Infiltration Cellular, Focal, Lymphocyte 1 (2%)
Necrosis, Diffuse 1 (2%)
Pigmentation, Focal 1 (2%)
Acinus, Atrophy, Diffuse 1 (2%) 1 (2%) 1 (2%)
Acinus, Atrophy, Focal 22 (44%) 18 (36%) 25 (50%) 31 (66%)
Acinus, Hyperplasia, Focal 1 (2%) 5 (10%) 4 (8%) 2 (4%)
Artery, Inflammation, Chronic 3 (6%)
Salivary Glands (50) (49) (49) (49)
Atrophy 1 (2%)
Duct, Sublingual Gland, Hyperplasia, Focal 1 (2%) 1 (2%)
Parotid Gland, Atrophy 1 (2%)
Parotid Gland, Atrophy, Focal 1 (2%)
Parotid Gland, Inflammation, Chronic Active 1 (2%)
Sublingual Gland, Atrophy 2 (4%)
Sublingual Gland, Inflammation, Chronic 1 (2%)
Submandibular Gland, Atrophy 1 (2%)
Stomach, Forestomach (50) (50) (50) (49)
Edema 1 (2%) 3 (6%) 1 (2%) 4 (8%)
Erosion, Focal 1 (2%) 2 (4%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 5 (10%) 2 (4%)
Ulcer, Focal 2 (4%) 2 (4%) 4 (8%) 3 (6%)
Epithelium, Hyperplasia 4 (8%) 2 (4%) 12 (24%) 9 (18%)
Muscularis, Mineralization 2 (4%) 2 (4%)
Stomach, Glandular (50) (50) (50) (49)
Degeneration 11 (22%) 5 (10%) 4 (8%)
Edema 1 (2%)
Erosion, Focal 8 (16%) 6 (12%) 4 (8%) 6 (12%)
Inflammation, Acute 1 (2%) 1 (2%)
Mineralization 11 (22%) 5 (10%) 5 (10%)
Mineralization, Focal 1 (2%)
Ulcer, Focal 1 (2%) 1 (2%)
Glands, Cyst, Focal 1 (2%) 2 (4%) 3 (6%)
Glands, Inflammation, Acute, Focal 1 (2%)
Muscularis, Mineralization 2 (4%)
Tooth (1)
Necrosis 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (49) (50) (50)
Aorta, Media, Mineralization 9 (18%) 3 (6%) 4 (8%)
Heart (50) (49) (50) (50)
Cardiomyopathy 39 (78%) 36 (73%) 41 (82%) 38 (76%)
Fibrosis 1 (2%)
Artery, Mineralization 1 (2%) 2 (4%)
Atrium, Thrombosis 3 (6%) 2 (4%) 2 (4%)
Atrium, Epicardium, Hyperplasia, Focal 1 (2%)
Atrium, Epicardium, Pigmentation 1 (2%)
Myocardium, Inflammation, Acute 2 (4%)
Myocardium, Mineralization 2 (4%) 1 (2%)
Valve, Inflammation, Acute 1 (2%)
Valve, Inflammation, Chronic Active 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Hyperplasia, Focal 4 (8%) 1 (2%) 1 (2%) 6 (12%)
Hypertrophy, Focal 2 (4%)
Inflammation 1 (2%)
Necrosis 2 (4%) 1 (2%)
Vacuolization Cytoplasmic, Focal 6 (12%) 11 (22%) 4 (8%) 7 (14%)
Bilateral, Hematopoietic Cell Proliferation 1 (2%)
Bilateral, Necrosis 4 (8%) 3 (6%) 1 (2%)
Bilateral, Vacuolization Cytoplasmic, Focal 2 (4%) 2 (4%) 1 (2%)
Adrenal Medulla (50) (50) (50) (50)
Hyperplasia, Focal 12 (24%) 21 (42%) 16 (32%) 19 (38%)
Infiltration Cellular, Lymphocyte 1 (2%)
Bilateral, Hyperplasia, Focal 1 (2%) 1 (2%) 2 (4%) 4 (8%)
Islets, Pancreatic (50) (50) (50) (48)
Hyperplasia, Focal 2 (4%) 2 (4%)
Parathyroid Gland (41) (48) (49) (46)
Hyperplasia, Diffuse 6 (13%) 3 (6%) 8 (17%)
Hyperplasia, Focal 1 (2%)
Bilateral, Hyperplasia 1 (2%)
Bilateral, Hyperplasia, Diffuse 10 (21%) 11 (22%) 6 (13%)
Pituitary Gland (50) (50) (50) (50)
Hyperplasia, Focal 1 (2%)
Pars Distalis, Angiectasis, Focal 1 (2%) 1 (2%)
Pars Distalis, Cyst 1 (2%) 4 (8%) 5 (10%) 5 (10%)
Pars Distalis, Hemorrhage, Focal 1 (2%)
Pars Distalis, Hyperplasia, Focal 9 (18%) 6 (12%) 4 (8%) 11 (22%)
Pars Distalis, Hypertrophy, Focal 1 (2%)
Pars Nervosa, Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Rathke's Cleft, Pigmentation 1 (2%)
Thyroid Gland (50) (50) (49) (49)
Necrosis 1 (2%)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia, Focal 13 (26%) 3 (6%) 9 (18%) 4 (8%)
Follicle, Cyst 3 (6%) 4 (8%) 7 (14%) 6 (12%)
Follicular Cell, Hyperplasia 1 (2%)
Follicular Cell, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Mediastinum, Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Granuloma Sperm, Focal 1 (2%)
Inflammation, Chronic 2 (4%) 1 (2%)
Polyarteritis 1 (2%)
Preputial Gland (50) (49) (50) (49)
Atrophy 1 (2%)
Cyst 1 (2%)
Hyperplasia, Focal 3 (6%) 2 (4%) 2 (4%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 14 (28%) 14 (29%) 8 (16%) 13 (27%)
Inflammation, Chronic Active 1 (2%) 2 (4%) 4 (8%) 4 (8%)
Bilateral, Inflammation, Chronic 21 (42%) 21 (43%) 25 (50%) 20 (41%)
Bilateral, Inflammation, Chronic Active 6 (12%) 8 (16%) 9 (18%) 4 (8%)
Duct, Hyperplasia 1 (2%)
Prostate (50) (50) (50) (50)
Atrophy 14 (28%) 8 (16%) 9 (18%) 13 (26%)
Inflammation, Acute 6 (12%) 5 (10%) 4 (8%) 10 (20%)
Inflammation, Chronic 1 (2%) 2 (4%) 1 (2%) 4 (8%)
Inflammation, Chronic Active 3 (6%) 7 (14%) 8 (16%) 5 (10%)
Epithelium, Hyperplasia, Focal 1 (2%) 2 (4%) 5 (10%) 3 (6%)
Seminal Vesicle (50) (50) (50) (50)
Atrophy 33 (66%) 44 (88%) 45 (90%) 47 (94%)
Inflammation, Acute 1 (2%)
Testes (50) (50) (50) (50)
Mineralization, Focal 1 (2%)
Bilateral, Artery, Inflammation, Chronic 1 (2%)
Bilateral, Interstitial Cell, Hyperplasia,
Focal 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Bilateral, Germinal Epithelium, Atrophy 4 (8%) 3 (6%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Germinal Epithelium, Atrophy 2 (4%) 1 (2%) 2 (4%)
Interstitial Cell, Hyperplasia, Focal 2 (4%) 2 (4%) 3 (6%) 3 (6%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (48) (50) (50) (49)
Atrophy 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Fibrosis 1 (2%)
Hemorrhage 2 (4%)
Hyperplasia 15 (31%) 18 (36%) 21 (42%) 26 (53%)
Myelofibrosis 1 (2%)
Necrosis 1 (2%) 2 (4%) 1 (2%)
Lymph Node (17) (22) (27) (20)
Infiltration Cellular, Histiocyte 1 (5%)
Iliac, Hyperplasia, Lymphoid 1 (4%) 1 (5%)
Iliac, Infiltration Cellular, Histiocyte 1 (5%)
Inguinal, Hyperplasia, Lymphoid 2 (7%)
Mediastinal, Hematopoietic Cell Proliferation 1 (5%)
Mediastinal, Hemorrhage 1 (6%) 1 (5%) 3 (11%) 1 (5%)
Mediastinal, Hyperplasia, Lymphoid 1 (5%) 4 (15%) 1 (5%)
Mediastinal, Infiltration Cellular,
Histiocyte 2 (7%) 1 (5%)
Mediastinal, Pigmentation 1 (6%) 1 (5%) 1 (4%) 2 (10%)
Pancreatic, Fibrosis 1 (5%)
Pancreatic, Hematopoietic Cell Proliferation 1 (5%)
Pancreatic, Hemorrhage 1 (6%) 1 (4%)
Renal, Congestion 1 (5%)
Renal, Hemorrhage 2 (12%) 3 (14%) 5 (19%) 2 (10%)
Renal, Hyperplasia, Lymphoid 2 (9%) 3 (11%) 2 (10%)
Renal, Infiltration Cellular, Histiocyte 1 (5%) 1 (4%) 2 (10%)
Renal, Pigmentation 1 (5%) 1 (4%) 2 (10%)
Lymph Node, Mandibular (50) (49) (49) (49)
Degeneration, Cystic 9 (18%) 6 (12%) 2 (4%) 5 (10%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 7 (14%) 6 (12%) 12 (24%) 7 (14%)
Infiltration Cellular, Histiocyte 2 (4%) 2 (4%) 4 (8%)
Inflammation, Chronic 1 (2%) 1 (2%)
Necrosis 1 (2%)
Pigmentation 1 (2%) 1 (2%)
Lymph Node, Mesenteric (50) (50) (47) (48)
Atrophy 1 (2%) 1 (2%)
Degeneration, Cystic 1 (2%)
Degeneration, Cystic, Focal 1 (2%)
Ectasia 1 (2%)
Hemorrhage 4 (8%) 2 (4%) 2 (4%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 2 (4%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Infiltration Cellular, Histiocyte 33 (66%) 18 (36%) 22 (47%) 23 (48%)
Inflammation, Chronic 1 (2%)
Spleen (50) (50) (50) (49)
Congestion 1 (2%) 6 (12%) 2 (4%)
Fibrosis 3 (6%) 8 (16%) 6 (12%) 4 (8%)
Hematopoietic Cell Proliferation 6 (12%) 5 (10%) 5 (10%) 6 (12%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%)
Pigmentation 1 (2%) 4 (8%) 2 (4%)
Capsule, Degeneration, Cystic 1 (2%)
Lymphoid Follicle, Atrophy 2 (4%) 8 (16%) 9 (18%) 12 (24%)
Thymus (50) (49) (47) (47)
Angiectasis, Focal 1 (2%)
Cyst 1 (2%)
Hemorrhage 3 (6%)
Necrosis, Diffuse 1 (2%)
Epithelial Cell, Hyperplasia 24 (48%) 25 (51%) 31 (66%) 22 (47%)
Thymocyte, Atrophy 33 (66%) 33 (67%) 37 (79%) 34 (72%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (43) (47) (48) (47)
Galactocele 8 (19%) 9 (19%) 13 (27%) 8 (17%)
Hyperplasia 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization, Focal 1 (2%)
Pigmentation 1 (2%) 7 (15%) 5 (11%)
Epithelium, Hyperplasia 1 (2%) 2 (4%) 2 (4%)
Skin (49) (50) (50) (50)
Fibrosis, Focal 1 (2%)
Hyperkeratosis 1 (2%)
Hyperplasia, Basal Cell 1 (2%)
Ulcer 1 (2%)
Artery, Thrombosis 1 (2%)
Epidermis, Hyperplasia 1 (2%)
Lip, Inflammation, Chronic Active 1 (2%)
Lip, Ulcer 1 (2%)
Subcutaneous Tissue, Inflammation, Acute 1 (2%)
Subcutaneous Tissue, Inflammation, Chronic
Active 1 (2%)
Vein, Inflammation, Acute 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Femur, Fibrous Osteodystrophy 17 (34%) 14 (28%) 12 (24%)
Femur, Hyperostosis 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Joint, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hydrocephalus 1 (2%) 1 (2%) 1 (2%)
Cerebellum, Gliosis, Focal 1 (2%)
Cerebellum, Inflammation, Acute, Focal 1 (2%)
Cerebrum, Inflammation, Acute 1 (2%)
Cerebrum, Necrosis 1 (2%)
Choroid Plexus, Cerebrum, Infiltration
Cellular, Lymphocyte 1 (2%)
Hippocampus, Cerebrum, Necrosis, Focal 1 (2%)
Meninges, Hemorrhage 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 3 (6%) 1 (2%) 2 (4%)
Foreign Body 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 3 (6%) 4 (8%)
Infiltration Cellular, Focal, Histiocyte 2 (4%)
Inflammation, Chronic Active 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 1 (2%) 2 (4%)
Artery, Mineralization 1 (2%) 1 (2%)
Interstitium, Inflammation, Acute 1 (2%)
Interstitium, Inflammation, Chronic 3 (6%) 8 (16%) 7 (14%) 6 (12%)
Interstitium, Inflammation, Chronic Active 1 (2%) 1 (2%)
Nose (50) (50) (50) (50)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Inflammation, Chronic Active 14 (28%) 12 (24%) 15 (30%) 16 (32%)
Metaplasia, Focal, Squamous 1 (2%) 2 (4%)
Metaplasia, Squamous 1 (2%) 1 (2%)
Nasolacrimal Duct, Inflammation, Acute 1 (2%) 1 (2%)
Nasolacrimal Duct, Inflammation, Chronic
Active 1 (2%) 1 (2%)
Trachea (50) (50) (50) (50)
Inflammation, Chronic Active 1 (2%)
Glands, Cyst, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 05182-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC PHENOLPHTHALEIN Date: 04/04/96
Route: DOSED FEED Time: 03:10:02
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 12000 25000 50000
PPM PPM PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2)
Cornea, Inflammation, Chronic 1 (100%) 1 (50%)
Cornea, Inflammation, Chronic Active 1 (50%)
Retina, Atrophy 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Cyst 1 (2%) 3 (6%) 8 (16%) 10 (20%)
Hydronephrosis 1 (2%)
Inflammation, Acute 1 (2%)
Mineralization, Focal 1 (2%)
Nephropathy, Chronic 2 (4%) 1 (2%) 1 (2%)
Bilateral, Cyst 16 (32%) 13 (26%) 12 (24%)
Bilateral, Inflammation, Acute 1 (2%)
Bilateral, Mineralization, Focal 2 (4%) 1 (2%) 1 (2%)
Bilateral, Nephropathy, Chronic 45 (90%) 48 (96%) 49 (98%) 50 (100%)
Bilateral, Pelvis, Transitional Epithelium,
Hyperplasia 1 (2%) 21 (42%) 20 (40%) 17 (34%)
Bilateral, Renal Tubule, Hyperplasia, Focal 1 (2%)
Bilateral, Renal Tubule, Pigmentation 10 (20%) 5 (10%) 7 (14%) 6 (12%)
Pelvis, Inflammation, Acute 1 (2%)
Pelvis, Transitional Epithelium, Hyperplasia 3 (6%) 10 (20%) 14 (28%) 12 (24%)
Renal Tubule, Hyperplasia, Focal 5 (10%) 7 (14%) 2 (4%)
Renal Tubule, Hyperplasia, Oncocytic 1 (2%)
Vein, Inflammation, Chronic 1 (2%)
Vein, Thrombosis 1 (2%)
Urinary Bladder (49) (50) (50) (50)
Hemorrhage 2 (4%)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
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