NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
CORE STUDY
Facility: Battelle Columbus Laboratory
Chemical CAS #: 93-15-2
Lock Date: 09/17/96
Cage Range: All
Reasons For Removal: 25022 Accidently Killed 25018 Dosing Accident
25019 Moribund Sacrifice 25020 Natural Death
25021 Terminal Sacrifice
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: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 50 50 50 60
Early Deaths
Natural Death 11 9 13 12 9
Moribund Sacrifice 17 16 14 26 25
Accidently Killed 1
Dosing Accident 1
Survivors
Terminal Sacrifice 22 25 22 11 16
Animals Examined Microscopically 50 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (50) (50) (50) (50) (50)
Parasite Metazoan 1 (2%) 1 (2%)
Ulcer 1 (2%)
Intestine Large, Rectum (50) (50) (50) (50) (50)
Parasite Metazoan 2 (4%) 4 (8%) 2 (4%) 2 (4%)
Intestine Large, Cecum (50) (50) (50) (50) (50)
Lymphoid Tissue, Hyperplasia 1 (2%)
Intestine Small, Duodenum (50) (50) (50) (50) (50)
Ulcer 1 (2%)
Liver (50) (50) (49) (49) (50)
Basophilic Focus 36 (72%) 36 (72%) 29 (59%) 17 (35%) 10 (20%)
Clear Cell Focus 3 (6%) 10 (20%) 12 (24%) 4 (8%) 7 (14%)
Degeneration, Cystic, Focal 1 (2%) 4 (8%) 29 (58%)
Eosinophilic Focus 10 (20%) 20 (40%) 27 (55%) 31 (63%) 37 (74%)
Hepatodiaphragmatic Nodule 7 (14%) 2 (4%) 6 (12%) 2 (4%) 3 (6%)
Inflammation, Granulomatous 1 (2%)
Mixed Cell Focus 6 (12%) 4 (8%) 19 (39%) 9 (18%) 7 (14%)
Necrosis, Focal 1 (2%) 1 (2%) 1 (2%)
Bile Duct, Cyst 2 (4%)
Bile Duct, Hyperplasia 11 (22%) 11 (22%) 17 (35%) 22 (45%) 30 (60%)
Centrilobular, Degeneration, Fatty 3 (6%)
Centrilobular, Necrosis 1 (2%) 1 (2%)
Centrilobular, Necrosis, Acute 1 (2%)
Hepatocyte, Hypertrophy 1 (2%) 13 (26%) 16 (33%) 26 (53%) 31 (62%)
Oval Cell, Hyperplasia 1 (2%) 15 (30%) 19 (39%) 35 (71%) 34 (68%)
Periportal, Degeneration, Fatty 1 (2%)
Mesentery (6) (5) (3) (3) (3)
Inflammation, Chronic 1 (33%)
Artery, Inflammation, Chronic 1 (17%)
Fat, Fibrosis 1 (33%)
Fat, Necrosis 5 (83%) 5 (100%) 2 (67%) 3 (100%) 2 (67%)
Oral Mucosa (1) (1)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Hyperplasia, Focal 1 (100%)
Pancreas (50) (50) (50) (49) (50)
Fibrosis 1 (2%)
Hyperplasia, Focal 1 (2%)
Acinus, Atrophy 10 (20%) 11 (22%) 8 (16%) 6 (12%) 4 (8%)
Salivary Glands (50) (48) (49) (49) (50)
Submandibular Gland, Cytoplasmic Alteration 1 (2%) 48 (100%) 49 (100%) 49 (100%) 49 (98%)
Stomach, Forestomach (50) (49) (50) (50) (50)
Hyperkeratosis, Diffuse 1 (2%)
Ulcer 2 (4%)
Stomach, Glandular (50) (50) (50) (48) (49)
Atrophy 3 (6%) 41 (82%) 45 (90%) 39 (81%) 33 (67%)
Mineralization 1 (2%)
Ulcer 3 (6%) 4 (8%) 4 (8%) 3 (6%)
Neuroendocrine Cell, Hyperplasia 5 (10%) 11 (22%) 9 (19%) 3 (6%)
Tongue (1) (1)
Hyperkeratosis, Focal 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (50) (50)
Aorta, Mineralization 1 (2%)
Heart (50) (50) (49) (49) (50)
Degeneration, Mucoid 1 (2%)
Atrium, Thrombosis 2 (4%) 1 (2%)
Myocardium, Degeneration 35 (70%) 30 (60%) 26 (53%) 20 (41%) 27 (54%)
Valve, Fibrosis 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49) (50)
Hyperplasia, Focal 13 (26%) 11 (22%) 7 (14%) 9 (18%) 5 (10%)
Necrosis 2 (4%) 1 (2%)
Bilateral, Hyperplasia 1 (2%)
Adrenal Medulla (50) (50) (50) (49) (50)
Hyperplasia, Focal 4 (8%) 9 (18%) 4 (8%) 3 (6%) 6 (12%)
Infarct 1 (2%)
Islets, Pancreatic (50) (50) (50) (50) (50)
Hyperplasia 1 (2%) 1 (2%)
Parathyroid Gland (44) (45) (41) (46) (45)
Hyperplasia 3 (7%)
Bilateral, Hyperplasia 1 (2%)
Pituitary Gland (50) (50) (50) (50) (49)
Angiectasis 4 (8%) 2 (4%) 2 (4%) 2 (4%)
Cyst 3 (6%) 2 (4%) 4 (8%) 2 (4%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Distalis, Hyperplasia, Diffuse 1 (2%)
Pars Distalis, Hyperplasia, Focal 11 (22%) 17 (34%) 14 (28%) 15 (30%) 6 (12%)
Pars Intermedia, Hyperplasia, Focal 1 (2%)
Rathke's Cleft, Cyst 1 (2%)
Thyroid Gland (50) (49) (49) (50) (48)
Inflammation, Focal, Suppurative 1 (2%)
C-Cell, Hyperplasia 32 (64%) 33 (67%) 30 (61%) 32 (64%) 32 (67%)
Follicle, Cyst 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (48) (46) (49) (46) (48)
Cyst 2 (4%) 1 (2%) 2 (4%) 1 (2%)
Hyperplasia, Focal 2 (4%) 3 (7%) 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
Inflammation, Suppurative 1 (2%)
Necrosis, Focal 1 (2%)
Ovary (50) (50) (49) (49) (50)
Cyst 2 (4%) 7 (14%) 2 (4%) 2 (4%) 4 (8%)
Uterus (50) (50) (49) (50) (50)
Hyperplasia, Cystic 2 (4%)
Cervix, Hyperplasia, Focal 1 (2%)
Endometrium, Degeneration 1 (2%)
Endometrium, Hyperplasia, Cystic 1 (2%)
Vagina (2) (2)
Infiltration Cellular, Polymorphonuclear 1 (50%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (49) (50) (50)
Fibrosis 2 (4%) 2 (4%) 2 (4%) 4 (8%)
Hyperplasia 4 (8%) 15 (30%) 11 (22%) 20 (40%) 25 (50%)
Inflammation, Granulomatous 2 (4%)
Necrosis 1 (2%) 2 (4%)
Erythroid Cell, Hyperplasia 1 (2%)
Myeloid Cell, Hyperplasia 1 (2%) 2 (4%)
Lymph Node (2) (5) (1) (10) (6)
Pancreatic, Erythrophagocytosis 1 (50%)
Pancreatic, Hyperplasia 1 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Pancreatic, Necrosis 1 (20%)
Renal, Ectasia 1 (10%)
Renal, Inflammation, Granulomatous 1 (17%)
Lymph Node, Mandibular (49) (48) (49) (49) (48)
Necrosis 1 (2%)
Lymph Node, Mesenteric (50) (49) (49) (49) (50)
Erythrophagocytosis 1 (2%)
Inflammation, Granulomatous 1 (2%)
Necrosis 1 (2%)
Spleen (50) (50) (50) (49) (50)
Fibrosis 3 (6%) 3 (6%) 5 (10%) 12 (24%) 15 (30%)
Hematopoietic Cell Proliferation 7 (14%) 6 (12%) 2 (4%) 12 (24%)
Inflammation, Focal, Suppurative 1 (2%)
Inflammation, Granulomatous 2 (4%) 1 (2%) 1 (2%)
Necrosis 1 (2%)
Lymphoid Follicle, Hyperplasia 1 (2%)
Red Pulp, Necrosis 2 (4%)
Thymus (49) (48) (46) (46) (49)
Atrophy 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50) (50)
Dilatation 27 (54%) 22 (44%) 34 (68%) 20 (40%) 10 (20%)
Galactocele 10 (20%) 10 (20%) 7 (14%) 6 (12%) 5 (10%)
Hyperplasia, Cystic 2 (4%) 2 (4%)
Hyperplasia, Focal 8 (16%) 7 (14%) 9 (18%) 2 (4%) 2 (4%)
Hyperplasia, Lobular 1 (2%)
Inflammation, Suppurative 1 (2%)
Skin (50) (50) (50) (50) (50)
Ulcer 1 (2%)
Dermis, Necrosis 1 (2%)
Dermis, Subcutaneous Tissue, Fibrosis 1 (2%) 1 (2%)
Hair Follicle, Atrophy, Focal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50) (50)
Fibrous Osteodystrophy 3 (6%)
Hyperostosis 1 (2%) 1 (2%) 5 (10%) 4 (8%) 2 (4%)
Osteopetrosis 1 (2%) 2 (4%)
Skeletal Muscle (1) (1) (1)
Degeneration, Focal 1 (100%)
Fibrosis 1 (100%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50) (50)
Congestion, Focal 1 (2%)
Hydrocephalus 4 (8%) 9 (18%) 3 (6%) 8 (16%) 9 (18%)
Cerebellum, Necrosis, Focal 1 (2%)
Hypothalamus, Degeneration 9 (18%) 12 (24%) 6 (12%) 7 (14%) 5 (10%)
Medulla, Degeneration 1 (2%)
Pons, Degeneration 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (49) (49) (50)
Inflammation, Acute 1 (2%) 2 (4%)
Inflammation, Chronic 1 (2%)
Inflammation, Granulomatous 1 (2%) 1 (2%) 2 (4%)
Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 3 (6%) 7 (14%) 3 (6%) 5 (10%)
Interstitium, Inflammation, Chronic 1 (2%) 1 (2%)
Interstitium, Mineralization 2 (4%)
Nose (50) (50) (50) (50) (50)
Hyperplasia, Squamous 1 (2%)
Inflammation, Suppurative 8 (16%) 10 (20%) 14 (28%) 3 (6%) 3 (6%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2)
Cataract 1 (100%) 1 (50%)
Degeneration 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (49) (50)
Hydronephrosis 2 (4%)
Infarct 3 (6%) 1 (2%)
Inflammation, Focal, Suppurative 1 (2%)
Necrosis 1 (2%)
Nephropathy 35 (70%) 42 (84%) 41 (82%) 44 (90%) 45 (90%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%)
Renal Tubule, Pigmentation, Lipofuscin 1 (2%) 1 (2%) 4 (8%) 3 (6%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 50 50 50 60
Early Deaths
Natural Death 15 15 17 29 26
Moribund Sacrifice 15 18 15 20 23
Dosing Accident 1 3 1 1
Survivors
Terminal Sacrifice 20 16 15
Animals Examined Microscopically 50 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50) (48)
Perforation 1 (2%) 1 (2%)
Periesophageal Tissue, Inflammation 1 (2%) 1 (2%)
Intestine Large, Colon (50) (50) (50) (50) (50)
Fibrosis 1 (2%)
Mineralization 4 (8%)
Necrosis 1 (2%)
Parasite Metazoan 1 (2%) 2 (4%) 5 (10%) 1 (2%) 1 (2%)
Intestine Large, Rectum (49) (49) (49) (50) (50)
Parasite Metazoan 1 (2%) 3 (6%) 5 (10%) 4 (8%) 1 (2%)
Intestine Large, Cecum (50) (50) (50) (50) (49)
Ulcer 1 (2%)
Intestine Small, Duodenum (50) (50) (50) (50) (49)
Ulcer 3 (6%) 1 (2%)
Peyer's Patch, Hyperplasia 1 (2%)
Intestine Small, Jejunum (50) (50) (50) (50) (50)
Inflammation, Chronic, Focal 1 (2%) 1 (2%)
Intestine Small, Ileum (50) (49) (50) (50) (49)
Mineralization 1 (2%)
Ulcer 1 (2%)
Liver (50) (50) (50) (50) (50)
Basophilic Focus 23 (46%) 21 (42%) 22 (44%) 7 (14%) 6 (12%)
Clear Cell Focus 4 (8%) 3 (6%) 7 (14%) 3 (6%) 3 (6%)
Degeneration, Cystic, Focal 4 (8%) 2 (4%) 25 (50%) 38 (76%) 41 (82%)
Degeneration, Fatty, Focal 1 (2%)
Eosinophilic Focus 11 (22%) 28 (56%) 43 (86%) 47 (94%) 39 (78%)
Hepatodiaphragmatic Nodule 4 (8%) 1 (2%)
Inflammation, Acute 1 (2%) 1 (2%)
Mixed Cell Focus 1 (2%) 7 (14%) 14 (28%) 8 (16%) 2 (4%)
Necrosis, Focal 2 (4%) 2 (4%) 5 (10%) 3 (6%) 2 (4%)
Bile Duct, Cyst 1 (2%)
Bile Duct, Hyperplasia 36 (72%) 17 (34%) 16 (32%) 17 (34%) 28 (56%)
Bile Duct, Hyperplasia, Atypical, Focal 1 (2%) 2 (4%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Centrilobular, Degeneration 6 (12%) 1 (2%)
Centrilobular, Degeneration, Fatty 2 (4%) 1 (2%)
Centrilobular, Necrosis 1 (2%) 4 (8%) 1 (2%) 1 (2%)
Hepatocyte, Hypertrophy 13 (26%) 25 (50%) 30 (60%) 26 (52%)
Oval Cell, Hyperplasia 14 (28%) 17 (34%) 24 (48%) 34 (68%) 27 (54%)
Mesentery (5) (6) (1) (1)
Fat, Necrosis 5 (100%) 6 (100%)
Pancreas (50) (50) (50) (50) (49)
Atrophy, Acute 1 (2%)
Hyperplasia, Focal 3 (6%) 2 (4%) 1 (2%) 2 (4%) 2 (4%)
Acinus, Atrophy 20 (40%) 15 (30%) 13 (26%) 9 (18%) 10 (20%)
Acinus, Hyperplasia, Focal 1 (2%) 1 (2%)
Artery, Inflammation, Chronic 4 (8%)
Salivary Glands (50) (50) (50) (48) (48)
Inflammation, Chronic 1 (2%)
Parotid Gland, Atrophy 1 (2%)
Submandibular Gland, Cytoplasmic Alteration 4 (8%) 50 (100%) 49 (98%) 48 (100%) 48 (100%)
Submandibular Gland, Fibrosis 1 (2%)
Stomach, Forestomach (50) (50) (50) (50) (49)
Hyperkeratosis 1 (2%)
Hyperkeratosis, Focal 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 3 (6%) 1 (2%) 6 (12%) 5 (10%)
Ulcer 7 (14%) 1 (2%) 1 (2%)
Stomach, Glandular (50) (50) (50) (50) (49)
Atrophy 14 (28%) 32 (64%) 37 (74%) 29 (59%)
Inflammation, Focal, Suppurative 2 (4%) 3 (6%) 1 (2%)
Mineralization 10 (20%) 4 (8%) 15 (30%) 14 (28%) 20 (41%)
Ulcer 4 (8%) 2 (4%) 3 (6%) 2 (4%) 8 (16%)
Neuroendocrine Cell, Hyperplasia 1 (2%) 8 (16%) 8 (16%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (50) (50) (50) (50) (50)
Mineralization 1 (2%) 2 (4%) 3 (6%) 7 (14%) 9 (18%)
Aorta, Hyperplasia 1 (2%)
Aorta, Mineralization 5 (10%) 9 (18%) 6 (12%) 10 (20%)
Heart (50) (50) (50) (50) (49)
Inflammation, Focal, Suppurative 1 (2%) 1 (2%)
Atrium, Thrombosis 6 (12%) 5 (10%) 4 (8%) 2 (4%)
Endocardium, Fibrosis 1 (2%)
Myocardium, Degeneration 45 (90%) 41 (82%) 34 (68%) 37 (74%) 25 (51%)
Myocardium, Mineralization 5 (10%) 2 (4%) 11 (22%) 9 (18%) 15 (31%)
Valve, Inflammation, Chronic 1 (2%)
Valve, Thrombosis 1 (2%)
Ventricle, Thrombosis 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (50) (50)
Hyperplasia, Focal 13 (26%) 12 (24%) 6 (12%) 4 (8%) 5 (10%)
Necrosis 1 (2%) 1 (2%)
Necrosis, Focal 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Focal 1 (2%)
Adrenal Medulla (50) (50) (50) (50) (50)
Hematocyst 1 (2%)
Hyperplasia 1 (2%)
Hyperplasia, Focal 16 (32%) 20 (40%) 21 (42%) 21 (42%) 14 (28%)
Islets, Pancreatic (50) (50) (50) (50) (49)
Hyperplasia 4 (8%) 1 (2%)
Parathyroid Gland (48) (49) (48) (45) (46)
Hyperplasia 7 (15%) 2 (4%) 6 (13%) 3 (7%) 7 (15%)
Hyperplasia, Focal 2 (4%) 1 (2%)
Bilateral, Hyperplasia 10 (21%) 6 (12%) 16 (33%) 18 (40%) 18 (39%)
Pituitary Gland (50) (50) (50) (50) (50)
Angiectasis 2 (4%) 2 (4%)
Cyst 1 (2%)
Hyperplasia, Focal 1 (2%)
Pars Distalis, Hyperplasia, Focal 12 (24%) 9 (18%) 8 (16%) 2 (4%) 1 (2%)
Pars Intermedia, Hyperplasia, Focal 1 (2%)
Pars Nervosa, Inflammation, Focal,
Suppurative 1 (2%)
Rathke's Cleft, Cyst 1 (2%)
Thyroid Gland (50) (50) (50) (48) (48)
C-Cell, Hyperplasia 22 (44%) 25 (50%) 25 (50%) 10 (21%) 17 (35%)
Follicle, Cyst 1 (2%) 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (49) (49) (50) (50)
Fibrosis 1 (2%)
Granuloma Sperm 1 (2%) 1 (2%)
Serosa, Hyperplasia, Mesothelium 2 (4%)
Preputial Gland (50) (50) (49) (50) (50)
Cyst 5 (10%) 2 (4%) 6 (12%) 4 (8%)
Fibrosis 1 (2%)
Hyperplasia, Focal 3 (6%) 4 (8%) 6 (12%) 4 (8%) 5 (10%)
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Inflammation, Chronic 9 (18%) 14 (28%) 8 (16%) 12 (24%) 4 (8%)
Inflammation, Chronic Active 1 (2%)
Prostate (50) (50) (49) (49) (49)
Hyperplasia 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%) 1 (2%)
Inflammation, Chronic 16 (32%) 18 (36%) 13 (27%) 15 (31%) 9 (18%)
Seminal Vesicle (50) (50) (50) (50) (50)
Inflammation, Suppurative 1 (2%) 2 (4%) 6 (12%) 3 (6%)
Mineralization 1 (2%) 3 (6%)
Epithelium, Atrophy 1 (2%)
Serosa, Hyperplasia, Mesothelium 1 (2%)
Testes (50) (49) (49) (50) (50)
Atrophy 1 (2%)
Germinal Epithelium, Atrophy 3 (6%) 1 (2%) 3 (6%) 1 (2%)
Interstitial Cell, Hyperplasia 3 (6%) 1 (2%)
Tunic, Hyperplasia, Mesothelium 3 (6%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (50) (50) (50) (50)
Fibrosis 3 (6%) 2 (4%)
Hyperplasia 18 (36%) 14 (28%) 22 (44%) 23 (46%) 18 (36%)
Necrosis 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Lymph Node (8) (4) (4) (4) (3)
Lumbar, Hyperplasia, Lymphoid 1 (25%)
Mediastinal, Erythrophagocytosis 1 (25%) 1 (33%)
Mediastinal, Hyperplasia, Lymphoid 2 (25%)
Mediastinal, Inflammation, Suppurative 1 (25%)
Lymph Node, Mesenteric (50) (50) (49) (50) (48)
Ectasia 1 (2%)
Erythrophagocytosis 1 (2%)
Inflammation, Suppurative 1 (2%)
Spleen (50) (50) (50) (50) (49)
Congestion 1 (2%) 1 (2%) 1 (2%)
Fibrosis 8 (16%) 11 (22%) 12 (24%) 12 (24%) 4 (8%)
Hematopoietic Cell Proliferation 2 (4%) 9 (18%) 2 (4%) 13 (26%) 4 (8%)
Hemorrhage 1 (2%)
Metaplasia, Lipocyte 1 (2%)
Lymphoid Follicle, Atrophy 1 (2%)
Lymphoid Follicle, Depletion Cellular 1 (2%)
Thymus (46) (45) (43) (42) (43)
Cyst 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (49) (49) (45) (46)
Dilatation 13 (26%) 13 (27%) 4 (8%) 7 (16%) 1 (2%)
Galactocele 1 (2%) 1 (2%)
Hyperplasia, Focal 1 (2%) 1 (2%)
Duct, Granuloma 1 (2%)
Skin (50) (50) (50) (50) (50)
Cyst Epithelial Inclusion 1 (2%)
Edema 1 (2%)
Ulcer 2 (4%) 1 (2%)
Dermis, Inflammation, Focal, Suppurative 1 (2%)
Pinna, Ulcer 1 (2%)
Subcutaneous Tissue, Fibrosis 1 (2%)
Subcutaneous Tissue, Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50) (50)
Fibrous Osteodystrophy 8 (16%) 2 (4%) 12 (24%) 14 (28%) 21 (42%)
Osteopetrosis 1 (2%) 2 (4%)
Cranium, Hyperostosis 1 (2%)
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NERVOUS SYSTEM
Brain (50) (50) (50) (50) (50)
Degeneration, Focal 1 (2%)
Hydrocephalus 2 (4%) 3 (6%) 3 (6%) 1 (2%) 1 (2%)
Necrosis 1 (2%)
Necrosis, Focal 2 (4%) 1 (2%) 1 (2%)
Hypothalamus, Degeneration 1 (2%) 1 (2%)
Spinal Cord (1) (1) (1)
Axon, Degeneration, Focal 1 (100%)
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RESPIRATORY SYSTEM
Lung (50) (50) (50) (50) (49)
Congestion 1 (2%)
Erythrophagocytosis 1 (2%)
Hemorrhage, Focal 1 (2%)
Infiltration Cellular, Histiocyte 1 (2%) 1 (2%)
Inflammation, Granulomatous 2 (4%) 2 (4%) 3 (6%) 2 (4%)
Inflammation, Suppurative 1 (2%) 3 (6%) 2 (4%) 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Alveolar Epithelium, Interstitium,
a Number of animals examined microscopically at site and number of animals with lesion
NTP Experiment-Test: 05187-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC METHYLEUGENOL Date: 07/20/98
Route: GAVAGE Time: 08:56:31
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FISCHER 344 RATS MALE 0 MG/KG 37 MG/KG 75 MG/KG 150 300
MG/KG MG/KG
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RESPIRATORY SYSTEM - CONT
Mineralization 1 (2%) 1 (2%)
Bronchiole, Inflammation, Suppurative 1 (2%)
Bronchus, Inflammation, Suppurative 1 (2%)
Interstitium, Inflammation, Chronic 2 (4%) 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Interstitium, Mineralization 4 (8%) 1 (2%) 8 (16%) 10 (20%) 18 (37%)
Perivascular, Edema 1 (2%) 1 (2%)
Vein, Thrombosis 1 (2%)
Nose (50) (50) (50) (50) (50)
Inflammation, Suppurative 11 (22%) 14 (28%) 20 (40%) 11 (22%) 9 (18%)
Trachea (50) (50) (50) (49) (48)
Inflammation 1 (2%)
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SPECIAL SENSES SYSTEM
Eye (1) (1) (2) (1)
Cataract 1 (100%) 1 (50%) 1 (100%)
Degeneration 1 (50%)
Cornea, Inflammation, Chronic 1 (100%)
Retina, Atrophy 1 (50%)
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URINARY SYSTEM
Kidney (50) (50) (50) (50) (50)
Hydronephrosis 2 (4%) 1 (2%)
Inflammation, Focal, Suppurative 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Nephropathy 49 (98%) 46 (92%) 48 (96%) 50 (100%) 47 (94%)
Renal Tubule, Cyst 2 (4%) 2 (4%)
Renal Tubule, Hyperplasia, Focal 5 (10%) 1 (2%) 7 (14%) 4 (8%) 3 (6%)
Renal Tubule, Hyperplasia, Oncocytic 2 (4%) 1 (2%)
Urinary Bladder (49) (50) (49) (49) (50)
Inflammation, Suppurative 1 (2%)
Ulcer 1 (2%) 1 (2%) 2 (4%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
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