TDMS Study 05035-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
4-HYDROXYACETANILIDE
NTP Experiment-Test: 05035-03 Report: PEIRPT03
Study Type: CHRONIC Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
Facility: TSI Mason Research
Chemical CAS #: 103-90-2
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: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Dead 6 4 3
Moribund 14 12 13 22
Survivors
Terminal Sacrifice 28 34 34 27
Dead 1
Moribund 1 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (47) (48) (50) (50)
Parasite Metazoan 2 (4%) 7 (15%) 4 (8%) 5 (10%)
Intestine Large, Colon (48) (49) (49) (49)
Parasite Metazoan 10 (21%) 7 (14%) 3 (6%) 7 (14%)
Intestine Large, Rectum (49) (49) (50) (50)
Parasite Metazoan 2 (4%) 9 (18%) 9 (18%) 10 (20%)
Artery, Inflammation, Chronic 1 (2%)
Intestine Small, Duodenum (48) (50) (50) (50)
Artery, Inflammation, Chronic 1 (2%)
Intestine Small, Jejunum (48) (48) (50) (50)
Parasite Metazoan 1 (2%)
Liver (50) (50) (50) (50)
Basophilic Focus 38 (76%) 39 (78%) 32 (64%) 20 (40%)
Clear Cell Focus 1 (2%) 2 (4%)
Cyst 1 (2%)
Fatty Change 15 (30%) 5 (10%) 11 (22%) 17 (34%)
Granuloma 26 (52%) 15 (30%) 7 (14%) 8 (16%)
Hepatodiaphragmatic Nodule 10 (20%) 8 (16%) 8 (16%) 6 (12%)
Hyperplasia, Focal 4 (8%) 2 (4%) 2 (4%) 8 (16%)
Hyperplasia, Multifocal 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Necrosis, Focal 2 (4%) 5 (10%) 5 (10%) 2 (4%)
Bile Duct, Cyst 1 (2%) 1 (2%)
Bile Duct, Hyperplasia 15 (30%) 15 (30%) 13 (26%) 19 (38%)
Hepatocyte, Hyperplasia 1 (2%)
Perivascular, Inflammation, Chronic 1 (2%)
Mesentery (6) (3) (6) (8)
Fat, Necrosis 5 (83%) 2 (67%) 6 (100%) 8 (100%)
Pancreas (47) (49) (49) (48)
Angiectasis 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Edema 1 (2%)
Acinus, Atrophy, Focal 15 (32%) 12 (24%) 9 (18%) 9 (19%)
Artery, Inflammation, Chronic 1 (2%)
Duct, Ectasia 1 (2%)
Stomach, Forestomach (50) (50) (50) (49)
Acanthosis 1 (2%) 2 (4%) 1 (2%)
Diverticulum 1 (2%)
Hyperkeratosis 2 (4%) 1 (2%) 4 (8%)
Hyperplasia, Basal Cell 4 (8%) 5 (10%)
Ulcer 3 (6%) 3 (6%) 2 (4%) 2 (4%)
Epithelium, Inflammation, Acute 1 (2%)
Perivascular, Inflammation, Chronic 1 (2%)
Submucosa, Edema 1 (2%)
Stomach, Glandular (49) (50) (50) (50)
Inflammation, Chronic 2 (4%) 2 (4%) 4 (8%)
Mineralization 1 (2%) 1 (2%)
Ulcer 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (1)
Inflammation, Subacute 1 (100%)
Heart (49) (50) (50) (50)
Cardiomyopathy 27 (55%) 29 (58%) 28 (56%) 30 (60%)
Artery, Inflammation, Chronic 1 (2%) 1 (2%)
Coronary Artery, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50) (49)
Atrophy 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Congestion 2 (4%) 1 (2%) 1 (2%)
Cytoplasmic Alteration, Focal 12 (24%) 7 (14%) 6 (12%) 13 (27%)
Hyperplasia 2 (4%)
Hypertrophy 2 (4%)
Necrosis, Focal 1 (2%) 1 (2%)
Vacuolization Cytoplasmic 1 (2%)
Adrenal Gland, Medulla (39) (47) (44) (47)
Hyperplasia 1 (3%)
Hyperplasia, Focal 4 (10%) 5 (11%) 5 (11%)
Parathyroid Gland (42) (46) (37) (42)
Hyperplasia 2 (4%)
Pituitary Gland (47) (50) (50) (49)
Pars Distalis, Angiectasis 5 (11%) 1 (2%) 4 (8%) 4 (8%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Cyst 22 (47%) 20 (40%) 17 (34%) 22 (45%)
Pars Distalis, Hemorrhage 2 (4%) 2 (4%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 7 (15%) 6 (12%) 10 (20%) 9 (18%)
Pars Intermedia, Cyst 1 (2%) 1 (2%)
Pars Intermedia, Hyperplasia 1 (2%)
Thyroid Gland (49) (50) (50) (50)
C-Cell, Hyperplasia 25 (51%) 26 (52%) 21 (42%) 15 (30%)
Follicle, Cyst 1 (2%)
Follicular Cell, Hyperplasia 3 (6%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (43) (47) (43) (40)
Abscess 5 (12%) 3 (6%) 2 (5%) 3 (8%)
Cyst 1 (2%) 5 (11%) 4 (9%) 1 (3%)
Ectasia 1 (2%) 1 (2%)
Fibrosis 1 (2%)
Inflammation, Acute 2 (5%) 2 (4%)
Inflammation, Chronic 3 (7%) 1 (2%) 2 (5%)
Ovary (49) (50) (50) (49)
Angiectasis 1 (2%)
Atrophy 2 (4%) 1 (2%)
Congestion 2 (4%)
Cyst 4 (8%) 3 (6%) 6 (12%) 3 (6%)
Uterus (49) (50) (50) (50)
Angiectasis 1 (2%)
Atrophy 1 (2%) 2 (4%) 2 (4%)
Dilatation 2 (4%) 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization, Focal 1 (2%)
Prolapse 1 (2%) 1 (2%)
Thrombosis 2 (4%) 2 (4%) 1 (2%)
Endometrium, Cyst 2 (4%) 3 (6%)
Endometrium, Hyperplasia, Cystic 2 (4%) 2 (4%)
Serosa, Inflammation, Acute 1 (2%)
Vagina (1) (2)
Cyst 1 (100%)
Metestrus 2 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (31) (6) (4) (29)
Lymphocytosis 1 (3%)
Bone Marrow (49) (49) (49) (50)
Hyperplasia 6 (12%) 12 (24%) 7 (14%) 17 (34%)
Myelofibrosis 5 (10%) 2 (4%) 5 (10%) 2 (4%)
Lymph Node (50) (49) (50) (50)
Inguinal, Lymphatic, Angiectasis 1 (2%)
Mediastinal, Congestion 2 (4%) 3 (6%) 1 (2%)
Mediastinal, Granuloma 1 (2%)
Mediastinal, Infiltration Cellular, Plasma
Cell 1 (2%)
Mediastinal, Lymphatic, Angiectasis 1 (2%)
Pancreatic, Congestion 2 (4%)
Renal, Angiectasis 1 (2%)
Renal, Congestion 1 (2%)
Renal, Granuloma 1 (2%)
Renal, Pigmentation 1 (2%)
Lymph Node, Mandibular (43) (46) (45) (44)
Congestion 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Granuloma 2 (5%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Plasma Cell 32 (74%) 38 (83%) 35 (78%) 28 (64%)
Lymphatic, Angiectasis 1 (2%) 1 (2%)
Lymph Node, Mesenteric (48) (48) (49) (50)
Congestion 1 (2%) 2 (4%) 3 (6%) 4 (8%)
Granuloma 36 (75%) 38 (79%) 34 (69%) 27 (54%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Plasma Cell 1 (2%)
Artery, Inflammation, Acute 1 (2%)
Artery, Thrombosis 1 (2%)
Lymphatic, Angiectasis 2 (4%)
Spleen (50) (50) (50) (50)
Congestion 1 (2%)
Granuloma 3 (6%) 1 (2%) 3 (6%)
Hematopoietic Cell Proliferation 33 (66%) 29 (58%) 23 (46%) 19 (38%)
Hemorrhage 1 (2%)
Infarct 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 23 (46%) 22 (44%) 28 (56%) 19 (38%)
Capsule, Hemorrhage 1 (2%)
Thymus (39) (42) (36) (42)
Congestion 1 (3%) 1 (3%)
Cyst 2 (5%) 1 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (47) (48) (43)
Abscess 1 (2%)
Ectasia 8 (17%) 2 (4%) 4 (8%) 3 (7%)
Galactocele 13 (28%) 8 (17%) 10 (21%) 8 (19%)
Hypertrophy 1 (2%)
Inflammation, Acute 1 (2%)
Skin (50) (46) (48) (48)
Abscess 1 (2%) 1 (2%)
Cyst Epithelial Inclusion 1 (2%)
Hemorrhage, Focal 1 (2%)
Hyperkeratosis 1 (2%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (50) (50) (50)
Hyperostosis 7 (14%) 3 (6%) 6 (12%) 10 (20%)
Skeletal Muscle (1)
Myopathy Degenerative 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (50) (50) (50)
Hemorrhage 3 (6%) 2 (4%) 1 (2%)
Hydrocephalus 7 (14%) 5 (10%) 5 (10%) 6 (12%)
Choroid Plexus, Perivascular, Inflammation,
Chronic 1 (2%)
Peripheral Nerve (1)
Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 3 (6%) 5 (10%) 2 (4%) 1 (2%)
Fungus 1 (2%)
Hemorrhage, Focal 3 (6%) 1 (2%)
Infiltration Cellular, Histiocyte 2 (4%)
Alveolar Epithelium, Metaplasia 1 (2%) 1 (2%)
Peribronchial, Inflammation, Chronic 20 (40%) 18 (36%) 22 (44%) 22 (44%)
Nose (47) (50) (50) (50)
Abscess 1 (2%)
Fungus 3 (6%) 2 (4%) 2 (4%)
Hemorrhage 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Inflammation, Acute 4 (9%) 7 (14%) 4 (8%)
Inflammation, Chronic 17 (36%) 21 (42%) 16 (32%) 14 (28%)
Metaplasia, Squamous 10 (21%) 14 (28%) 18 (36%) 14 (28%)
Respiratory Epithelium, Degeneration, Hyaline 6 (13%) 1 (2%) 1 (2%) 4 (8%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (3) (1) (1) (2)
Inflammation, Chronic 1 (100%)
Ulcer, Multifocal 1 (100%)
Eye (9) (11) (7) (9)
Cornea, Inflammation, Acute, Focal 1 (9%)
Lens, Degeneration 2 (22%)
Retina, Degeneration 2 (18%) 1 (14%) 3 (33%)
Harderian Gland (8) (8) (5) (5)
Inflammation, Chronic 2 (25%) 1 (13%) 1 (20%)
Pigmentation 7 (88%) 7 (88%) 4 (80%) 5 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Abscess, Multiple 1 (2%)
Calculus Gross Observation 1 (2%)
Cyst 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Nephropathy 48 (96%) 49 (98%) 47 (94%) 43 (86%)
Artery, Inflammation, Chronic 1 (2%)
Artery, Inflammation, Subacute 1 (2%)
Pelvis, Transitional Epithelium, Hyperplasia 2 (4%)
Renal Tubule, Cyst 1 (2%)
Renal Tubule, Degeneration 1 (2%)
Renal Tubule, Hyperplasia 1 (2%)
Renal Tubule, Pigmentation 1 (2%) 1 (2%) 2 (4%) 3 (6%)
Urinary Bladder (44) (45) (49) (50)
Calculus Gross Observation 1 (2%)
Inflammation, Chronic 6 (13%) 2 (4%) 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Transitional Epithelium, Hyperplasia, Diffuse 1 (2%)
Transitional Epithelium, Hyperplasia, Focal 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund 22 20 25 22
Dead 1 2 2 4
Survivors
Terminal Sacrifice 27 28 23 24
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (48) (49) (49) (48)
Parasite Metazoan 6 (13%) 5 (10%) 7 (14%) 4 (8%)
Ulcer 1 (2%) 1 (2%)
Intestine Large, Colon (48) (49) (50) (50)
Parasite Metazoan 9 (19%) 8 (16%) 5 (10%) 5 (10%)
Intestine Large, Rectum (50) (47) (47) (49)
Parasite Metazoan 12 (24%) 10 (21%) 7 (15%) 8 (16%)
Intestine Small, Duodenum (50) (50) (50) (50)
Artery, Inflammation, Chronic 1 (2%)
Muscularis, Hypertrophy 1 (2%) 1 (2%)
Intestine Small, Jejunum (50) (48) (49) (49)
Ulcer 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis 2 (4%) 1 (2%)
Basophilic Focus 6 (12%) 2 (4%) 1 (2%) 2 (4%)
Clear Cell Focus 1 (2%) 2 (4%)
Congestion 1 (2%) 2 (4%) 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%)
Eosinophilic Focus 1 (2%)
Fatty Change 9 (18%) 7 (14%) 9 (18%) 3 (6%)
Granuloma 2 (4%) 1 (2%)
Hemorrhage, Focal 1 (2%)
Hepatodiaphragmatic Nodule 3 (6%) 5 (10%) 5 (10%) 4 (8%)
Hyperplasia, Focal 3 (6%) 1 (2%) 1 (2%) 4 (8%)
Hyperplasia, Multifocal 1 (2%)
Necrosis, Focal 3 (6%) 5 (10%) 6 (12%) 1 (2%)
Bile Duct, Hyperplasia 42 (84%) 44 (88%) 43 (86%) 43 (86%)
Centrilobular, Necrosis 1 (2%)
Subserosa, Thrombosis 1 (2%)
Mesentery (3) (9) (3) (2)
Accessory Spleen 1 (33%)
Edema 1 (50%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fibrosis 1 (11%)
Inflammation, Acute 1 (11%)
Fat, Necrosis 1 (33%) 3 (33%) 2 (67%) 1 (50%)
Pancreas (49) (49) (47) (47)
Congestion 1 (2%)
Ectopic Tissue 1 (2%)
Edema 1 (2%) 1 (2%)
Hemorrhage, Focal 1 (2%)
Pigmentation, Focal, Hemosiderin 1 (2%)
Acinus, Atrophy, Focal 26 (53%) 17 (35%) 16 (34%) 20 (43%)
Artery, Hypertrophy 1 (2%)
Artery, Inflammation, Chronic 2 (4%)
Salivary Glands (50) (50) (50) (50)
Karyomegaly 45 (90%) 44 (88%) 46 (92%) 48 (96%)
Stomach, Forestomach (49) (50) (46) (50)
Acanthosis 2 (4%) 1 (2%) 1 (2%) 2 (4%)
Bulla 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Basal Cell 3 (6%) 4 (9%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Perforation 1 (2%) 1 (2%)
Ulcer 4 (8%) 2 (4%) 3 (7%) 1 (2%)
Serosa, Inflammation, Chronic 1 (2%)
Stomach, Glandular (50) (50) (50) (50)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Mineralization 1 (2%) 1 (2%) 2 (4%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 40 (80%) 40 (80%) 42 (84%) 35 (70%)
Dilatation 1 (2%)
Atrium, Inflammation, Chronic 1 (2%) 1 (2%)
Atrium, Thrombosis 4 (8%) 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50) (50)
Atrophy 1 (2%)
Congestion 1 (2%)
Cytoplasmic Alteration, Focal 4 (8%) 6 (12%) 9 (18%) 3 (6%)
Hemorrhage, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia, Focal 1 (2%)
Necrosis, Focal 2 (4%)
Vacuolization Cytoplasmic 1 (2%) 1 (2%) 1 (2%)
Adrenal Gland, Medulla (44) (49) (49) (46)
Hyperplasia 2 (4%)
Hyperplasia, Focal 8 (18%) 9 (18%) 8 (16%) 5 (11%)
Necrosis, Focal 1 (2%)
Islets, Pancreatic (49) (49) (46) (48)
Hyperplasia 1 (2%) 1 (2%) 2 (4%)
Parathyroid Gland (42) (45) (46) (45)
Hyperplasia 4 (9%) 6 (13%) 8 (18%)
Pituitary Gland (48) (49) (49) (48)
Pars Distalis, Angiectasis 1 (2%) 2 (4%)
Pars Distalis, Cyst 2 (4%) 4 (8%) 1 (2%) 2 (4%)
Pars Distalis, Hyperplasia, Focal 18 (38%) 15 (31%) 15 (31%) 10 (21%)
Pars Distalis, Pigmentation, Hemosiderin 2 (4%) 1 (2%)
Pars Intermedia, Pigmentation, Hemosiderin 1 (2%)
Thyroid Gland (50) (50) (50) (50)
C-Cell, Hyperplasia 15 (30%) 12 (24%) 17 (34%) 13 (26%)
Follicle, Cyst 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Degeneration, Focal 1 (2%)
Penis (1) (1)
Concretion 1 (100%) 1 (100%)
Preputial Gland (48) (50) (49) (47)
Abscess 3 (6%) 1 (2%) 5 (10%) 3 (6%)
Cyst 2 (4%) 1 (2%)
Ectasia 1 (2%) 1 (2%)
Hyperplasia 2 (4%)
Inflammation, Acute 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Inflammation, Chronic 17 (35%) 15 (30%) 13 (27%) 15 (32%)
Inflammation, Subacute 1 (2%)
Prostate (47) (49) (50) (49)
Abscess 1 (2%)
Atrophy 13 (28%) 16 (33%) 17 (34%) 13 (27%)
Hyperplasia, Focal 1 (2%) 3 (6%)
Inflammation, Acute 6 (13%) 6 (12%) 5 (10%) 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Chronic 7 (15%) 6 (12%) 5 (10%) 7 (14%)
Inflammation, Subacute 1 (2%)
Metaplasia, Squamous 1 (2%)
Seminal Vesicle (48) (49) (50) (50)
Atrophy 30 (63%) 35 (71%) 32 (64%) 29 (58%)
Dilatation 1 (2%) 2 (4%)
Inflammation, Acute 1 (2%)
Testes (50) (50) (50) (50)
Cyst 1 (2%)
Hemorrhage 1 (2%)
Hypospermia 1 (2%)
Artery, Inflammation 1 (2%)
Interstitial Cell, Hyperplasia 1 (2%) 2 (4%) 5 (10%) 3 (6%)
Seminiferous Tubule, Atrophy 37 (74%) 36 (72%) 33 (66%) 25 (50%)
Seminiferous Tubule, Hypospermia 1 (2%) 3 (6%) 2 (4%) 4 (8%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (49)
Hyperplasia 19 (38%) 20 (40%) 20 (40%) 20 (41%)
Myelofibrosis 3 (6%) 2 (4%) 3 (6%)
Lymph Node (50) (50) (50) (49)
Inguinal, Infiltration Cellular, Plasma Cell 1 (2%)
Lumbar, Infiltration Cellular, Plasma Cell 1 (2%)
Mediastinal, Congestion 1 (2%) 1 (2%) 1 (2%)
Mediastinal, Infiltration Cellular, Plasma
Cell 1 (2%) 1 (2%) 1 (2%)
Mediastinal, Lymphatic, Angiectasis 1 (2%) 1 (2%)
Pancreatic, Congestion 1 (2%) 1 (2%)
Pancreatic, Infiltration Cellular, Plasma
Cell 1 (2%)
Pancreatic, Lymphatic, Angiectasis 1 (2%)
Renal, Congestion 1 (2%)
Renal, Infiltration Cellular, Plasma Cell 2 (4%)
Renal, Lymphatic, Angiectasis 1 (2%)
Lymph Node, Mandibular (47) (45) (49) (45)
Angiectasis 1 (2%)
Congestion 1 (2%) 4 (8%)
Granuloma 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Plasma Cell 34 (72%) 38 (84%) 38 (78%) 27 (60%)
Lymphatic, Angiectasis 3 (6%) 5 (11%) 5 (11%)
Lymph Node, Mesenteric (49) (50) (50) (48)
Congestion 3 (6%) 1 (2%) 4 (8%) 3 (6%)
Granuloma 23 (47%) 30 (60%) 25 (50%) 22 (46%)
Infiltration Cellular, Plasma Cell 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Lymphatic, Angiectasis 7 (14%) 2 (4%) 5 (10%) 4 (8%)
Spleen (50) (50) (50) (50)
Congestion 2 (4%) 1 (2%) 1 (2%)
Fibrosis, Focal 2 (4%) 3 (6%) 6 (12%)
Granuloma 1 (2%)
Hematopoietic Cell Proliferation 11 (22%) 13 (26%) 15 (30%) 20 (40%)
Necrosis, Focal 1 (2%)
Pigmentation, Hemosiderin 4 (8%) 9 (18%) 8 (16%) 5 (10%)
Thrombosis 1 (2%)
Capsule, Fibrosis, Focal 1 (2%)
Thymus (40) (37) (40) (42)
Atrophy 1 (3%)
Congestion 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (36) (34) (35) (36)
Abscess 1 (3%)
Ectasia 5 (14%) 5 (15%) 3 (9%) 5 (14%)
Galactocele 3 (8%) 1 (3%)
Hypertrophy 1 (3%)
Skin (50) (50) (48) (49)
Acanthosis 1 (2%)
Hyperkeratosis 1 (2%) 2 (4%)
Hyperplasia, Basal Cell 1 (2%) 1 (2%)
Dermis, Fibrosis 1 (2%)
Subcutaneous Tissue, Lymphatic, Dilatation 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (50) (50) (49)
Hydrocephalus 6 (12%) 4 (8%) 4 (8%) 4 (8%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 1 (2%) 3 (6%) 3 (6%)
Fungus 1 (2%)
Granuloma 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Hemorrhage, Focal 1 (2%)
Inflammation, Focal, Subacute 1 (2%)
Alveolar Epithelium, Metaplasia 1 (2%) 3 (6%) 4 (8%) 3 (6%)
Alveolus, Inflammation, Acute, Focal 1 (2%)
Interstitium, Inflammation, Chronic 1 (2%)
Peribronchial, Inflammation, Chronic 25 (50%) 20 (40%) 15 (30%) 18 (36%)
Pleura, Fibrosis 1 (2%)
Pleura, Inflammation, Chronic, Focal 1 (2%)
Nose (49) (50) (50) (49)
Cyst 1 (2%)
Fibrosis 1 (2%)
Fungus 6 (12%) 4 (8%) 3 (6%) 3 (6%)
Hemorrhage 2 (4%) 1 (2%)
Inflammation, Acute 4 (8%) 5 (10%) 6 (12%) 4 (8%)
Inflammation, Chronic 20 (41%) 22 (44%) 17 (34%) 10 (20%)
Metaplasia, Squamous 35 (71%) 30 (60%) 30 (60%) 22 (45%)
Parasite Metazoan 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (5) (11) (8)
Anterior Chamber, Fibrosis 1 (9%)
Anterior Chamber, Inflammation, Acute 1 (13%)
Lens, Degeneration 1 (33%) 2 (25%)
Retina, Degeneration 2 (25%)
Retrobulbar, Hemorrhage 1 (13%)
Harderian Gland (4) (5) (9) (6)
Inflammation, Chronic 2 (22%)
Pigmentation 4 (100%) 4 (80%) 9 (100%) 6 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Atrophy, Focal 1 (2%)
Congestion 1 (2%)
Cyst 1 (2%)
Fibrosis, Focal 1 (2%) 1 (2%)
Mineralization, Focal 1 (2%) 1 (2%)
Nephropathy 50 (100%) 50 (100%) 50 (100%) 49 (98%)
Cortex, Necrosis, Focal 1 (2%) 1 (2%)
Interstitial Tissue, Hyperplasia 1 (2%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%)
Renal Tubule, Cyst 2 (4%) 2 (4%) 1 (2%) 4 (8%)
Renal Tubule, Hyperplasia 1 (2%) 5 (10%) 3 (6%) 5 (10%)
Renal Tubule, Necrosis, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Renal Tubule, Pigmentation 3 (6%) 5 (10%) 2 (4%) 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
Transitional Epithelium, Hyperplasia, Focal 2 (4%) 1 (2%)
Urinary Bladder (49) (48) (47) (46)
Concretion 2 (4%) 1 (2%)
Inflammation, Chronic 2 (4%) 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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