TDMS Study 05035-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
4-HYDROXYACETANILIDE
NTP Experiment-Test: 05035-02 Report: PEIRPT03
Study Type: CHRONIC Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
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: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE 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
Moribund 21 9 21 8
Dead 2 9 4
Accident 4
Survivors
Terminal Sacrifice 27 32 25 38
Animals Examined Microscopically 50 50 50 51
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (42) (45) (44) (46)
Degeneration, Hyaline 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Serosa, Inflammation, Chronic 1 (2%)
Intestine Large, Cecum (49) (45) (49) (48)
Hyperplasia, Lymphoid 1 (2%)
Intestine Large, Colon (47) (44) (47) (48)
Parasite Metazoan 1 (2%)
Intestine Large, Rectum (47) (46) (49) (48)
Artery, Inflammation 1 (2%)
Intestine Small, Ileum (48) (43) (48) (47)
Amyloid Deposition 1 (2%) 1 (2%)
Intestine Small, Jejunum (47) (42) (46) (48)
Amyloid Deposition 1 (2%)
Liver (49) (50) (50) (49)
Angiectasis, Focal 2 (4%)
Clear Cell Focus 1 (2%)
Congestion 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%) 1 (2%)
Eosinophilic Focus 1 (2%)
Fatty Change 9 (18%) 4 (8%) 4 (8%) 3 (6%)
Hematopoietic Cell Proliferation 6 (12%) 3 (6%) 5 (10%) 5 (10%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Inflammation, Focal, Granulomatous 1 (2%)
Mixed Cell Focus 1 (2%) 1 (2%)
Necrosis, Focal 14 (29%) 3 (6%) 6 (12%) 9 (18%)
Artery, Mineralization 1 (2%)
Centrilobular, Necrosis 1 (2%)
Hepatocyte, Hyperplasia, Focal 1 (2%)
Periductular, Fibrosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Perivascular, Inflammation, Chronic 9 (18%) 9 (18%) 13 (26%) 12 (24%)
Mesentery (4) (4) (3) (1)
Hemorrhage 1 (25%)
Inflammation, Acute 1 (25%) 1 (25%) 2 (67%)
Fat, Necrosis 3 (75%) 2 (50%) 1 (33%) 1 (100%)
Pancreas (49) (48) (47) (49)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic, Focal 21 (43%) 17 (35%) 14 (30%) 19 (39%)
Acinus, Atrophy 4 (8%) 1 (2%)
Acinus, Hyperplasia 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Duct, Ectasia 2 (4%) 1 (2%)
Salivary Glands (46) (49) (50) (50)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 2 (4%)
Hypoplasia 1 (2%)
Inflammation, Chronic, Focal 33 (72%) 32 (65%) 29 (58%) 31 (62%)
Stomach, Forestomach (48) (49) (49) (48)
Acanthosis 3 (6%)
Cyst Epithelial Inclusion 1 (2%)
Hyperkeratosis 4 (8%) 2 (4%)
Hyperplasia, Squamous 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Stomach, Glandular (47) (47) (50) (48)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 9 (19%) 9 (19%) 6 (12%) 5 (10%)
Inflammation, Chronic Active 2 (4%)
Mineralization, Focal 2 (4%)
Artery, Inflammation 1 (2%)
Tooth (1) (1) (1)
Abscess 1 (100%)
Inflammation, Acute 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic, Focal 3 (6%)
Mineralization, Focal 1 (2%)
Atrium, Thrombosis 1 (2%)
Coronary Artery, Inflammation, Acute 1 (2%)
Coronary Artery, Inflammation, Chronic 1 (2%)
Pericardium, Inflammation, Acute 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (49) (49) (46) (49)
Capsule, Hyperplasia 2 (4%) 2 (4%) 1 (2%)
Subcapsular, Hyperplasia 1 (2%)
Adrenal Gland, Cortex (49) (49) (46) (49)
Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%)
Angiectasis 1 (2%)
Atrophy 2 (4%)
Congestion 1 (2%) 2 (4%) 1 (2%)
Cyst 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Vacuolization Cytoplasmic 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Adrenal Gland, Medulla (46) (46) (45) (47)
Congestion 1 (2%) 3 (7%) 1 (2%)
Hyperplasia 1 (2%)
Islets, Pancreatic (48) (47) (43) (49)
Hyperplasia 7 (15%) 2 (4%) 2 (5%) 6 (12%)
Pituitary Gland (46) (43) (42) (45)
Congestion 1 (2%)
Pars Distalis, Angiectasis 1 (2%) 1 (2%)
Pars Distalis, Cyst 1 (2%)
Pars Distalis, Hyperplasia 2 (4%) 2 (5%)
Pars Distalis, Hyperplasia, Focal 13 (28%) 6 (14%) 13 (31%) 13 (29%)
Thyroid Gland (48) (50) (50) (50)
Inflammation, Acute, Focal 1 (2%)
Inflammation, Chronic 2 (4%)
Inflammation, Chronic, Focal 4 (8%) 5 (10%) 2 (4%) 11 (22%)
Follicular Cell, Cyst 1 (2%)
Follicular Cell, Hyperplasia, Focal 2 (4%) 8 (16%) 11 (22%) 25 (50%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (1)
Dilatation 1 (100%)
Ovary (47) (49) (49) (50)
Abscess 5 (11%) 8 (16%) 8 (16%) 3 (6%)
Congestion 2 (4%) 1 (2%)
Cyst 17 (36%) 20 (41%) 12 (24%) 10 (20%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Granulomatous 1 (2%)
Thrombosis 2 (4%)
Corpus Luteum, Hypertrophy 1 (2%)
Follicle, Hemorrhage 2 (4%)
Uterus (49) (50) (50) (49)
Abscess 3 (6%) 2 (4%)
Angiectasis 1 (2%)
Atrophy 1 (2%)
Dilatation 3 (6%) 1 (2%) 1 (2%) 5 (10%)
Inflammation, Acute 2 (4%) 5 (10%) 3 (6%) 1 (2%)
Thrombosis 1 (2%) 1 (2%)
Endometrium, Angiectasis 2 (4%)
Endometrium, Cyst 1 (2%)
Endometrium, Hyperplasia, Cystic 33 (67%) 33 (66%) 35 (70%) 31 (63%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (49) (49) (49)
Angiectasis 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Neutrophil 8 (16%) 10 (20%) 13 (27%) 2 (4%)
Myelofibrosis 30 (61%) 27 (55%) 21 (43%) 35 (71%)
Lymph Node (49) (47) (49) (49)
Axillary, Hyperplasia, Lymphoid 1 (2%)
Lumbar, Congestion 1 (2%) 2 (4%)
Lumbar, Infiltration Cellular, Plasma Cell 4 (8%) 2 (4%) 1 (2%)
Lumbar, Inflammation, Acute 1 (2%) 1 (2%)
Lymphatic, Angiectasis 1 (2%)
Mediastinal, Abscess 1 (2%) 1 (2%) 1 (2%)
Mediastinal, Congestion 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%)
Mediastinal, Infiltration Cellular, Plasma
Cell 1 (2%) 5 (11%) 2 (4%)
Pancreatic, Infiltration Cellular, Plasma
Cell 1 (2%)
Renal, Angiectasis 1 (2%)
Renal, Congestion 2 (4%)
Renal, Infiltration Cellular, Plasma Cell 3 (6%) 3 (6%) 3 (6%) 1 (2%)
Renal, Necrosis 1 (2%)
Renal, Lymphatic, Angiectasis 1 (2%) 1 (2%)
Lymph Node, Mandibular (41) (26) (29) (44)
Congestion 1 (4%) 1 (2%)
Hematopoietic Cell Proliferation 1 (4%)
Hyperplasia, Lymphoid 2 (5%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Infiltration Cellular, Plasma Cell 6 (15%) 6 (23%) 7 (24%) 9 (20%)
Inflammation, Acute 1 (4%)
Lymph Node, Mesenteric (44) (45) (45) (43)
Amyloid Deposition 1 (2%)
Congestion 4 (9%) 2 (4%) 3 (7%) 2 (5%)
Hematopoietic Cell Proliferation 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 2 (5%) 3 (7%) 1 (2%)
Infiltration Cellular, Plasma Cell 1 (2%) 2 (4%) 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Inflammation, Acute 2 (5%)
Spleen (49) (50) (50) (49)
Congestion 1 (2%)
Hematopoietic Cell Proliferation 31 (63%) 37 (74%) 32 (64%) 36 (73%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 11 (22%) 8 (16%) 5 (10%) 8 (16%)
Inflammation, Acute 1 (2%)
Pigmentation, Hemosiderin 1 (2%) 4 (8%)
Thymus (23) (30) (30) (34)
Congestion 1 (3%)
Hyperplasia, Lymphoid 2 (9%)
Infiltration Cellular, Plasma Cell 1 (4%) 1 (3%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (47) (48) (49) (48)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (49) (50) (50)
Sternum, Necrosis 1 (2%)
Tarsal, Hyperostosis 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Congestion 2 (4%)
Hemorrhage, Focal 1 (2%)
Hydrocephalus 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Mineralization, Focal 24 (48%) 31 (62%) 28 (56%) 31 (62%)
Artery, Inflammation, Chronic 1 (2%)
Choroid Plexus, Inflammation, Chronic, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 1 (2%) 5 (10%) 1 (2%)
Giant Cell 1 (2%)
Granuloma 2 (4%)
Hemorrhage, Focal 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 2 (4%)
Inflammation, Acute, Focal 1 (2%)
Alveolar Epithelium, Metaplasia 1 (2%) 1 (2%)
Perivascular, Inflammation, Chronic 33 (66%) 27 (54%) 22 (44%) 32 (64%)
Pleura, Inflammation, Acute 2 (4%) 1 (2%)
Pleura, Inflammation, Chronic 1 (2%)
Nose (47) (44) (45) (38)
Inflammation, Chronic 4 (9%) 1 (2%) 5 (11%)
Metaplasia, Squamous 18 (38%) 15 (34%) 10 (22%) 6 (16%)
Respiratory Epithelium, Degeneration, Hyaline 28 (60%) 30 (68%) 27 (60%) 22 (58%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (1) (6)
Inflammation, Chronic 1 (17%)
Eye (1) (1) (1)
Degeneration 1 (100%)
Retina, Degeneration 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (49) (50) (49)
Atrophy, Focal 1 (2%) 1 (2%)
Congestion 3 (6%) 1 (2%)
Glomerulosclerosis 13 (27%) 5 (10%) 8 (16%) 8 (16%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Infiltration Cellular, Plasma Cell 1 (2%)
Inflammation, Chronic, Focal 25 (51%) 22 (45%) 26 (52%) 26 (53%)
Mineralization 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Cortex, Degeneration 1 (2%)
Cortex, Necrosis, Focal 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Interstitial Tissue, Inflammation 1 (2%)
Papilla, Necrosis 1 (2%)
Renal Tubule, Pigmentation 1 (2%)
Renal Tubule, Regeneration 6 (12%) 1 (2%) 2 (4%)
Urinary Bladder (49) (46) (44) (46)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Inflammation, Chronic, Focal 37 (76%) 30 (65%) 35 (80%) 36 (78%)
Artery, Inflammation, Chronic 1 (2%)
Transitional Epithelium, Hyperplasia, Focal 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE 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 13 3 16 10
Dead 5 7 3 9
Survivors
Terminal Sacrifice 32 40 31 31
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (47) (48) (48) (49)
Acanthosis 1 (2%)
Cyst 1 (2%)
Hyperkeratosis 1 (2%)
Gallbladder (41) (43) (47) (40)
Inflammation, Chronic, Focal 1 (2%)
Intestine Large, Cecum (49) (50) (48) (47)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic 1 (2%)
Intestine Large, Colon (48) (46) (49) (47)
Hyperplasia, Lymphoid 1 (2%)
Intestine Large, Rectum (49) (47) (47) (47)
Artery, Inflammation, Chronic 1 (2%)
Intestine Small, Ileum (48) (45) (48) (44)
Amyloid Deposition 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Intestine Small, Jejunum (47) (43) (47) (45)
Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Liver (50) (50) (50) (50)
Abscess 1 (2%) 1 (2%)
Abscess, Multiple 1 (2%)
Basophilic Focus 1 (2%) 2 (4%)
Cytoplasmic Alteration, Focal 4 (8%)
Fatty Change 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 2 (4%)
Infarct 1 (2%)
Mineralization, Focal 1 (2%)
Necrosis, Focal 3 (6%) 3 (6%) 6 (12%) 3 (6%)
Thrombosis 1 (2%)
Hepatocyte, Hyperplasia, Focal 1 (2%) 1 (2%) 2 (4%)
Perivascular, Inflammation, Chronic 2 (4%) 1 (2%) 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (4) (2) (1)
Hemorrhage 1 (50%)
Fat, Necrosis 4 (100%) 1 (50%)
Pancreas (47) (49) (50) (48)
Congestion 2 (4%)
Edema 1 (2%)
Inflammation, Chronic, Focal 4 (9%) 10 (20%) 5 (10%) 9 (19%)
Acinus, Atrophy 3 (6%) 1 (2%)
Acinus, Hyperplasia 1 (2%)
Acinus, Vacuolization Cytoplasmic 1 (2%)
Duct, Ectasia 1 (2%)
Periductular, Inflammation, Acute 1 (2%)
Salivary Glands (50) (49) (50) (49)
Congestion 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Inflammation, Chronic, Focal 38 (76%) 36 (73%) 35 (70%) 31 (63%)
Karyomegaly 1 (2%)
Stomach, Forestomach (49) (49) (50) (49)
Acanthosis 1 (2%) 2 (4%)
Cyst 1 (2%)
Cyst Epithelial Inclusion 1 (2%)
Hyperkeratosis 1 (2%) 1 (2%)
Hyperplasia, Squamous 1 (2%)
Inflammation, Chronic 1 (2%)
Stomach, Glandular (50) (47) (49) (48)
Inflammation, Acute 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Inflammation, Chronic 7 (14%) 2 (4%) 5 (10%) 4 (8%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Mineralization, Focal 1 (2%)
Tooth (2) (1) (1) (2)
Abscess 2 (100%) 1 (100%) 1 (100%) 1 (50%)
Inflammation, Acute 1 (50%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Cardiomyopathy 1 (2%) 2 (4%)
Inflammation, Chronic, Focal 1 (2%)
Karyomegaly 1 (2%)
Atrium, Thrombosis 1 (2%)
Coronary Artery, Inflammation, Acute 1 (2%)
Coronary Artery, Inflammation, Chronic 1 (2%) 2 (4%)
Myocardium, Inflammation, Acute, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (50) (48) (49) (49)
Capsule, Hyperplasia 1 (2%)
Adrenal Gland, Cortex (50) (48) (49) (49)
Accessory Adrenal Cortical Nodule 1 (2%)
Cytoplasmic Alteration, Focal 5 (10%) 10 (21%) 5 (10%) 6 (12%)
Hypertrophy 1 (2%)
Inflammation, Chronic 1 (2%)
Adrenal Gland, Medulla (47) (48) (48) (48)
Congestion 1 (2%)
Hyperplasia 8 (17%) 7 (15%) 5 (10%) 5 (10%)
Inflammation, Acute 1 (2%)
Islets, Pancreatic (47) (48) (48) (48)
Hyperplasia 11 (23%) 4 (8%) 9 (19%) 7 (15%)
Pituitary Gland (48) (39) (39) (46)
Pars Distalis, Congestion 2 (5%) 1 (2%)
Pars Distalis, Cyst 3 (6%) 1 (3%) 3 (8%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 1 (3%)
Thyroid Gland (49) (49) (50) (50)
Congestion 1 (2%)
Inflammation, Chronic, Focal 5 (10%) 2 (4%) 3 (6%)
C-Cell, Hyperplasia 1 (2%)
Follicle, Cyst 1 (2%)
Follicle, Inflammation, Acute, Focal 1 (2%)
Follicular Cell, Hyperplasia, Focal 6 (12%) 12 (24%) 15 (30%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Abscess 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Ectopic Tissue 1 (2%)
Inflammation, Chronic 3 (6%) 1 (2%)
Spermatocele 1 (2%)
Duct, Dilatation 1 (2%)
Penis (2) (2) (1) (1)
Abscess 1 (50%) 1 (100%)
Inflammation, Acute 1 (50%) 1 (100%)
Inflammation, Subacute 1 (50%)
Necrosis 1 (50%) 1 (100%)
Preputial Gland (17) (22) (12) (11)
Abscess 4 (24%) 8 (36%) 6 (50%) 3 (27%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Ectasia 4 (24%) 3 (14%) 3 (25%) 1 (9%)
Inflammation, Chronic 11 (65%) 13 (59%) 4 (33%) 6 (55%)
Prostate (48) (42) (47) (48)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Acute 2 (4%)
Inflammation, Chronic 9 (19%) 10 (24%) 5 (11%) 7 (15%)
Inflammation, Subacute 1 (2%)
Seminal Vesicle (49) (49) (49) (50)
Abscess 1 (2%)
Atrophy 3 (6%) 1 (2%) 1 (2%)
Dilatation 4 (8%) 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Testes (50) (50) (50) (50)
Congestion 1 (2%)
Hemorrhage 1 (2%)
Hypospermia, Focal 1 (2%) 1 (2%)
Mineralization 4 (8%) 2 (4%)
Capsule, Fibrosis 1 (2%)
Capsule, Inflammation, Chronic 1 (2%)
Seminiferous Tubule, Atrophy 5 (10%) 6 (12%) 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1)
Hypochromasia 1 (100%)
Bone Marrow (50) (49) (50) (49)
Hyperplasia, Neutrophil 4 (8%) 7 (14%) 6 (12%) 4 (8%)
Lymph Node (49) (47) (47) (47)
Axillary, Hyperplasia, Lymphoid 1 (2%)
Axillary, Infiltration Cellular, Plasma Cell 2 (4%)
Inguinal, Congestion 1 (2%)
Inguinal, Hyperplasia, Lymphoid 1 (2%)
Inguinal, Infiltration Cellular, Plasma Cell 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Lumbar, Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Lumbar, Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%) 2 (4%)
Lumbar, Inflammation, Acute 1 (2%)
Mediastinal, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Mediastinal, Infiltration Cellular, Plasma
Cell 1 (2%) 1 (2%)
Pancreatic, Congestion 1 (2%)
Renal, Congestion 1 (2%) 1 (2%)
Renal, Hyperplasia, Lymphoid 2 (4%)
Renal, Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Lymph Node, Mandibular (43) (20) (17) (40)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Lymphoid 1 (2%) 1 (6%)
Infiltration Cellular, Plasma Cell 19 (44%) 15 (75%) 11 (65%) 31 (78%)
Lymph Node, Mesenteric (43) (45) (47) (42)
Congestion 14 (33%) 18 (40%) 13 (28%) 17 (40%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Plasma Cell 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%)
Inflammation, Acute 1 (2%)
Lymphatic, Angiectasis 1 (2%)
Spleen (50) (50) (49) (48)
Atrophy 1 (2%)
Congestion 2 (4%)
Depletion Lymphoid 1 (2%)
Hematopoietic Cell Proliferation 19 (38%) 18 (36%) 16 (33%) 17 (35%)
Hyperplasia, Lymphoid 6 (12%) 2 (4%) 5 (10%) 1 (2%)
Infiltration Cellular, Plasma Cell 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Thymus (11) (18) (28) (22)
Hyperplasia, Lymphoid 1 (6%) 1 (4%)
Infiltration Cellular, Plasma Cell 1 (5%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (48) (49) (50) (50)
Alopecia 1 (2%)
Fibrosis 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Ulcer 6 (13%) 3 (6%) 3 (6%)
Dermis, Inflammation, Chronic 2 (4%) 1 (2%)
Epidermis, Inflammation, Acute 1 (2%)
Perivascular, Inflammation 1 (2%)
Scrotal, Subcutaneous Tissue, Thrombosis 1 (2%)
Scrotal, Subcutaneous Tissue, Lymphatic,
Dilatation 1 (2%)
Subcutaneous Tissue, Abscess 1 (2%)
Subcutaneous Tissue, Hyperplasia, Lymphoid 1 (2%) 1 (2%)
Subcutaneous Tissue, Infiltration Cellular,
Plasma Cell 1 (2%)
Subcutaneous Tissue, Inflammation, Acute 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: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (49) (50) (50)
Hyperostosis 1 (2%)
Cranium, Fibrous Osteodystrophy 1 (2%)
Tarsal, Fibrosis 1 (2%)
Tarsal, Hyperostosis 44 (88%) 35 (71%) 41 (82%) 39 (78%)
Tarsal, Inflammation, Acute 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Hemorrhage, Focal 1 (2%)
Mineralization, Focal 19 (38%) 23 (46%) 19 (38%) 18 (36%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 1 (2%) 3 (6%) 2 (4%)
Granuloma 1 (2%)
Hemorrhage, Focal 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 6 (12%) 1 (2%) 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Alveolar Epithelium, Hyperplasia 1 (2%)
Alveolar Epithelium, Metaplasia 1 (2%) 2 (4%)
Bronchiole, Epithelium, Hyperplasia 1 (2%) 1 (2%)
Bronchus, Foreign Body 1 (2%)
Perivascular, Inflammation, Chronic 22 (44%) 24 (48%) 9 (18%) 21 (42%)
Pleura, Inflammation, Chronic 1 (2%) 1 (2%)
Nose (47) (40) (46) (44)
Inflammation, Chronic 1 (2%) 7 (18%) 5 (11%) 2 (5%)
Metaplasia, Squamous 17 (36%) 20 (50%) 19 (41%) 13 (30%)
Respiratory Epithelium, Degeneration, Hyaline 21 (45%) 25 (63%) 30 (65%) 19 (43%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (3) (1)
Cornea, Degeneration 1 (33%)
Cornea, Inflammation, Acute 1 (33%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05035-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/04/94
Route: DOSED FEED Time: 22:25:07
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50) (50)
Abscess 1 (2%)
Congestion 2 (4%) 3 (6%) 4 (8%) 4 (8%)
Cyst 1 (2%) 2 (4%)
Fibrosis, Focal 2 (4%)
Glomerulosclerosis 7 (14%) 1 (2%) 3 (6%) 6 (12%)
Hydronephrosis 1 (2%)
Hyperplasia, Lymphoid 2 (4%) 1 (2%)
Inflammation, Acute, Focal 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Inflammation, Chronic, Focal 26 (52%) 18 (37%) 22 (44%) 28 (56%)
Inflammation, Subacute 1 (2%)
Mineralization 1 (2%) 3 (6%) 2 (4%) 2 (4%)
Necrosis, Focal 1 (2%) 4 (8%)
Nephropathy, Focal 1 (2%)
Capsule, Fibrosis 1 (2%)
Papilla, Necrosis 2 (4%) 1 (2%)
Pelvis, Inflammation, Acute 1 (2%)
Renal Tubule, Atrophy, Focal 1 (2%)
Renal Tubule, Casts 1 (2%) 1 (2%)
Renal Tubule, Degeneration 1 (2%) 1 (2%)
Renal Tubule, Dilatation 1 (2%)
Renal Tubule, Hyperplasia, Focal 1 (2%) 2 (4%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Regeneration 25 (50%) 15 (31%) 16 (32%) 25 (50%)
Urethra (2)
Hemorrhage 1 (50%)
Inflammation, Acute 2 (100%)
Urinary Bladder (47) (46) (46) (45)
Calculus Gross Observation 1 (2%) 1 (2%)
Calculus Micro Observation Only 1 (2%)
Concretion 1 (2%) 1 (2%) 2 (4%)
Ectasia 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic, Focal 23 (49%) 25 (54%) 18 (39%) 19 (42%)
Inflammation, Chronic Active 2 (4%)
Inflammation, Subacute 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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