TDMS Study 05217-03 Pathology Tables
NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 Facility: Southern Research Institute Chemical CAS #: 1948-33-0 Lock Date: 05/26/93 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: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 70 70 70 70 Scheduled Sacrifice 10 10 10 10 10 Early Deaths Moribund Sacrifice 40 31 41 33 36 Natural Death 10 7 8 9 7 Survivors Terminal Sacrifice 10 22 11 16 17 Other 2 Animals Examined Microscopically 70 70 70 68 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (68) (69) (70) (67) (70) Inflammation, Subacute 1 (1%) Epithelium, Hyperplasia 1 (1%) Intestine Large, Colon (70) (70) (69) (66) (69) Edema 1 (1%) Parasite Metazoan 6 (9%) 3 (4%) 4 (6%) 4 (6%) 5 (7%) Ulcer 1 (1%) Intestine Large, Rectum (69) (70) (69) (67) (69) Edema 1 (1%) Parasite Metazoan 2 (3%) 2 (3%) 6 (9%) 9 (13%) Intestine Large, Cecum (70) (70) (70) (67) (70) Edema 1 (1%) 2 (3%) 1 (1%) 2 (3%) Parasite Metazoan 2 (3%) 2 (3%) 1 (1%) 3 (4%) 1 (1%) Intestine Small, Duodenum (69) (70) (70) (67) (70) Erosion 1 (1%) Epithelium, Hyperplasia 1 (1%) 1 (1%) Intestine Small, Ileum (70) (70) (68) (67) (68) Inflammation, Chronic Active 1 (1%) Epithelium, Hyperplasia 1 (1%) Liver (70) (70) (70) (68) (70) Angiectasis 1 (1%) 2 (3%) 2 (3%) 1 (1%) 2 (3%) Basophilic Focus 26 (37%) 34 (49%) 31 (44%) 31 (46%) 29 (41%) Clear Cell Focus 2 (3%) 4 (6%) 4 (6%) 5 (7%) Degeneration, Cystic 1 (1%) 1 (1%) 1 (1%) Eosinophilic Focus 10 (14%) 12 (17%) 13 (19%) 12 (18%) 17 (24%) Eosinophilic Focus, Multiple 1 (1%) Hematopoietic Cell Proliferation 1 (1%) 3 (4%) 1 (1%) 2 (3%) Hemorrhage 4 (6%) Hepatodiaphragmatic Nodule 14 (20%) 12 (17%) 10 (14%) 9 (13%) 19 (27%) Inflammation, Granulomatous 12 (17%) 9 (13%) 9 (13%) 9 (13%) 10 (14%) Mixed Cell Focus 2 (3%) 3 (4%) 6 (9%) 8 (12%) 7 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Necrosis, Focal 6 (9%) 2 (3%) 3 (4%) 5 (7%) 3 (4%) Bile Duct, Cyst 1 (1%) 1 (1%) Bile Duct, Hyperplasia 17 (24%) 18 (26%) 20 (29%) 18 (26%) 24 (34%) Centrilobular, Atrophy 1 (1%) Centrilobular, Necrosis 1 (1%) 1 (1%) Hepatocyte, Vacuolization Cytoplasmic 14 (20%) 7 (10%) 14 (20%) 9 (13%) 3 (4%) Kupffer Cell, Pigmentation 12 (17%) 9 (13%) 14 (20%) 7 (10%) 9 (13%) Mesentery (11) (5) (13) (10) (7) Accessory Spleen 1 (9%) 3 (60%) 1 (8%) 2 (29%) Fat, Necrosis 9 (82%) 2 (40%) 12 (92%) 8 (80%) 5 (71%) Pancreas (70) (70) (70) (67) (69) Atrophy 20 (29%) 20 (29%) 22 (31%) 14 (21%) 13 (19%) Metaplasia, Hepatocyte 1 (1%) Acinus, Cytoplasmic Alteration 1 (1%) 1 (1%) 1 (1%) Acinus, Hyperplasia, Focal 1 (1%) 2 (3%) Salivary Glands (70) (70) (70) (68) (70) Atrophy 2 (3%) 1 (1%) Cyst 1 (1%) Inflammation, Chronic 1 (1%) Stomach, Forestomach (70) (70) (70) (67) (69) Edema 4 (6%) 2 (3%) 3 (4%) 4 (6%) Erosion 1 (1%) 2 (3%) 1 (1%) Hyperplasia 1 (1%) 1 (1%) Ulcer 2 (3%) 4 (6%) 4 (6%) 3 (4%) 2 (3%) Mucosa, Hyperplasia 5 (7%) 9 (13%) 9 (13%) 8 (12%) 5 (7%) Stomach, Glandular (70) (70) (70) (67) (70) Edema 1 (1%) 1 (1%) 1 (1%) 2 (3%) Erosion 3 (4%) 1 (1%) 2 (3%) 6 (9%) 2 (3%) Ulcer 2 (3%) 4 (6%) 4 (6%) 1 (1%) Tongue (1) (1) (1) (4) (1) Epithelium, Hyperplasia 2 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (70) (70) (70) (68) (70) Inflammation, Subacute 1 (1%) Heart (70) (70) (70) (68) (70) Cardiomyopathy 28 (40%) 35 (50%) 32 (46%) 26 (38%) 28 (40%) Thrombosis 3 (4%) 1 (1%) 3 (4%) Valve, Inflammation, Chronic 1 (1%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (70) (70) (70) (68) (70) Accessory Adrenal Cortical Nodule 14 (20%) 9 (13%) 14 (20%) 9 (13%) 10 (14%) Atrophy 1 (1%) Degeneration, Fatty 9 (13%) 8 (11%) 16 (23%) 17 (25%) 12 (17%) Fibrosis 1 (1%) Hemorrhage 1 (1%) 2 (3%) 1 (1%) Hyperplasia, Diffuse 3 (4%) 1 (1%) 1 (1%) 1 (1%) Hyperplasia, Focal 4 (6%) 6 (9%) 7 (10%) 4 (6%) 2 (3%) Hypertrophy, Focal 9 (13%) 8 (11%) 6 (9%) 4 (6%) 7 (10%) Metaplasia, Osseous 1 (1%) Necrosis 2 (3%) 2 (3%) 1 (1%) Adrenal Medulla (70) (70) (70) (68) (70) Hyperplasia 5 (7%) 7 (10%) 11 (16%) 7 (10%) 7 (10%) Islets, Pancreatic (70) (70) (69) (67) (69) Hyperplasia 1 (1%) 1 (1%) Parathyroid Gland (62) (64) (65) (63) (62) Hyperplasia 1 (2%) 1 (2%) 1 (2%) Pituitary Gland (70) (69) (70) (67) (70) Pars Distalis, Angiectasis 8 (11%) 7 (10%) 3 (4%) 6 (9%) 7 (10%) Pars Distalis, Atypia Cellular 1 (1%) Pars Distalis, Cyst 16 (23%) 11 (16%) 25 (36%) 17 (25%) 19 (27%) Pars Distalis, Hyperplasia, Focal 9 (13%) 7 (10%) 15 (21%) 1 (1%) 9 (13%) Pars Intermedia, Angiectasis 2 (3%) 2 (3%) Pars Intermedia, Cyst 2 (3%) 5 (7%) 4 (6%) 3 (4%) Thyroid Gland (70) (69) (70) (67) (70) Ectopic Thymus 1 (1%) 1 (1%) 1 (1%) Ultimobranchial Cyst 4 (6%) 2 (3%) 4 (6%) 2 (3%) C-Cell, Hyperplasia 8 (11%) 9 (13%) 9 (13%) 3 (4%) 8 (11%) Follicle, Cyst 1 (1%) 2 (3%) 1 (1%) Follicular Cell, Hyperplasia 1 (1%) 1 (1%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (68) (69) (69) (68) (70) Cyst 2 (3%) 5 (7%) 7 (10%) 6 (9%) 5 (7%) Cyst, Multiple 1 (1%) Fibrosis 1 (1%) Hyperplasia 3 (4%) 4 (6%) 6 (9%) 3 (4%) 4 (6%) Inflammation, Chronic 3 (4%) 1 (1%) 2 (3%) 2 (3%) 2 (3%) Inflammation, Suppurative 2 (3%) 3 (4%) 3 (4%) 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Ovary (70) (70) (70) (67) (70) Angiectasis 1 (1%) Cyst 17 (24%) 9 (13%) 11 (16%) 19 (28%) 18 (26%) Uterus (70) (70) (70) (68) (70) Hydrometra 4 (6%) 9 (13%) 10 (14%) 4 (6%) 9 (13%) Hyperplasia, Cystic 4 (6%) 4 (6%) 5 (7%) 2 (3%) 3 (4%) Cervix, Hypertrophy 1 (1%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (70) (70) (70) (67) (70) Depletion Cellular 1 (1%) 1 (1%) Fibrosis 1 (1%) Hyperplasia 1 (1%) 1 (1%) Infiltration Cellular, Histiocyte 1 (1%) Inflammation, Granulomatous 1 (1%) Myelofibrosis 2 (3%) 1 (1%) 4 (6%) 1 (1%) 3 (4%) Stromal Cell, Hyperplasia 1 (1%) Lymph Node (20) (14) (24) (19) (18) Hyperplasia, Lymphoid 1 (4%) Iliac, Hemorrhage 1 (7%) Iliac, Hyperplasia, Lymphoid 1 (7%) Inguinal, Ectasia 1 (5%) Inguinal, Hemorrhage 1 (5%) Inguinal, Hyperplasia, Lymphoid 1 (5%) Mediastinal, Ectasia 1 (5%) Mediastinal, Hemorrhage 3 (15%) 1 (7%) 1 (4%) 7 (37%) Mediastinal, Hyperplasia, Lymphoid 1 (5%) Mediastinal, Pigmentation 14 (70%) 3 (21%) 9 (38%) 11 (58%) 6 (33%) Pancreatic, Hemorrhage 1 (5%) Pancreatic, Pigmentation 1 (5%) 2 (14%) 6 (25%) 4 (21%) 4 (22%) Renal, Hemorrhage 2 (11%) Renal, Pigmentation 1 (5%) 3 (21%) 2 (8%) 7 (39%) Lymph Node, Mandibular (69) (70) (70) (65) (70) Ectasia 2 (3%) 2 (3%) 2 (3%) 4 (6%) 1 (1%) Hemorrhage 5 (7%) 3 (4%) 3 (4%) 5 (8%) 2 (3%) Hyperplasia, Lymphoid 13 (19%) 12 (17%) 9 (13%) 14 (22%) 7 (10%) Hyperplasia, Plasma Cell 1 (1%) 1 (1%) Pigmentation 20 (29%) 27 (39%) 19 (27%) 26 (40%) 25 (36%) Lymph Node, Mesenteric (68) (69) (70) (65) (70) Ectasia 2 (3%) 2 (3%) 2 (3%) 2 (3%) Hemorrhage 4 (6%) 1 (1%) 9 (14%) 7 (10%) Hyperplasia, Lymphoid 2 (3%) 4 (6%) 2 (3%) 3 (5%) 4 (6%) Pigmentation 1 (1%) 1 (2%) 1 (1%) Spleen (70) (70) (70) (67) (70) Developmental Malformation 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Fibrosis 3 (4%) 4 (6%) 5 (7%) 3 (4%) 3 (4%) Hematopoietic Cell Proliferation 15 (21%) 12 (17%) 12 (17%) 17 (25%) 11 (16%) Hemorrhage 1 (1%) Hyperplasia, Lymphoid 1 (1%) Metaplasia, Lipocyte 1 (1%) Necrosis 2 (3%) 2 (3%) 1 (1%) Pigmentation, Hemosiderin 29 (41%) 31 (44%) 34 (49%) 41 (61%) 51 (73%) Lymphoid Follicle, Atrophy 1 (1%) 1 (1%) Red Pulp, Atrophy 1 (1%) 1 (1%) 1 (1%) Thymus (66) (66) (70) (67) (67) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (70) (70) (69) (68) (70) Dilatation 37 (53%) 33 (47%) 48 (70%) 39 (57%) 34 (49%) Galactocele 5 (7%) 1 (1%) 4 (6%) 1 (1%) 5 (7%) Hyperplasia 12 (17%) 12 (17%) 6 (9%) 11 (16%) 15 (21%) Inflammation, Suppurative 1 (1%) Skin (70) (69) (70) (67) (70) Cyst Epithelial Inclusion 1 (1%) 1 (1%) Hyperkeratosis 1 (1%) 1 (1%) Inflammation, Chronic 1 (1%) 2 (3%) Ulcer 2 (3%) 1 (1%) 1 (1%) 2 (3%) Epidermis, Hyperplasia 1 (1%) 2 (3%) 2 (3%) 2 (3%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (70) (70) (69) (68) (70) Fibrous Osteodystrophy 1 (1%) 1 (1%) Hyperostosis 1 (1%) Cranium, Osteopetrosis 8 (11%) 17 (24%) 9 (13%) 6 (9%) 9 (13%) Femur, Osteopetrosis 9 (13%) 17 (24%) 10 (14%) 6 (9%) 5 (7%) Skeletal Muscle (1) (1) (1) (1) (1) Hemorrhage 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (70) (70) (68) (70) Atrophy 19 (27%) 22 (31%) 20 (29%) 25 (37%) 22 (31%) Gliosis 1 (1%) Hemorrhage 1 (1%) Hydrocephalus 4 (6%) 4 (6%) 1 (1%) 3 (4%) 8 (11%) Necrosis 1 (1%) 1 (1%) 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (70) (70) (70) (68) (70) Congestion 1 (1%) Edema 2 (3%) 1 (1%) Hemorrhage 2 (3%) 1 (1%) 1 (1%) 1 (1%) 2 (3%) Infiltration Cellular, Histiocyte 28 (40%) 33 (47%) 24 (34%) 30 (44%) 23 (33%) Inflammation, Subacute 7 (10%) 4 (6%) 1 (1%) 3 (4%) 2 (3%) Thrombosis 1 (1%) Alveolar Epithelium, Hyperplasia 5 (7%) 6 (9%) 5 (7%) 2 (3%) 5 (7%) Nose (70) (70) (70) (68) (70) Foreign Body 3 (4%) 1 (1%) 3 (4%) Inflammation, Suppurative 5 (7%) 3 (4%) 2 (3%) 11 (16%) 3 (4%) Goblet Cell, Hyperplasia 10 (14%) 8 (11%) 2 (3%) 3 (4%) 7 (10%) Mucosa, Hyperplasia 5 (7%) 1 (1%) 1 (1%) 12 (18%) 1 (1%) Mucosa, Metaplasia, Squamous 3 (4%) 2 (3%) 4 (6%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (4) (1) (3) (1) Cataract 3 (75%) 1 (100%) 3 (100%) 1 (100%) Hemorrhage 1 (25%) 1 (33%) Inflammation, Chronic 1 (33%) Retina, Degeneration 4 (100%) 1 (100%) 3 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (70) (70) (67) (70) Cyst 1 (1%) 3 (4%) Hydronephrosis 1 (1%) 1 (1%) Inflammation, Chronic 1 (1%) 1 (1%) 1 (1%) 3 (4%) 5 (7%) Inflammation, Suppurative 2 (3%) 1 (1%) 1 (1%) Mineralization 67 (96%) 62 (89%) 66 (94%) 54 (81%) 58 (83%) Nephropathy 37 (53%) 38 (54%) 38 (54%) 37 (55%) 39 (56%) Renal Tubule, Atrophy 1 (1%) 1 (1%) 4 (6%) 5 (7%) Renal Tubule, Cytoplasmic Alteration 5 (7%) 3 (4%) 3 (4%) 4 (6%) 2 (3%) Renal Tubule, Dilatation 1 (1%) 1 (1%) Renal Tubule, Necrosis 2 (3%) 1 (1%) 1 (1%) 1 (1%) 2 (3%) Renal Tubule, Pigmentation 15 (21%) 9 (13%) 16 (23%) 11 (16%) 16 (23%) Transitional Epithelium, Hyperplasia 2 (3%) 4 (6%) 2 (3%) 6 (9%) 3 (4%) Urinary Bladder (69) (70) (70) (68) (69) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Transitional Epithelium, Hyperplasia 1 (1%) 1 (1%) 1 (1%) 2 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 70 70 70 70 Scheduled Sacrifice 10 10 10 10 10 Early Deaths Moribund Sacrifice 48 41 51 50 42 Natural Death 4 7 2 7 4 Survivors Terminal Sacrifice 8 12 7 1 14 Other 2 Animals Examined Microscopically 70 70 70 68 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (68) (70) (68) (68) (70) Edema 1 (1%) 1 (1%) Parasite Metazoan 7 (10%) 6 (9%) 6 (9%) 3 (4%) 3 (4%) Intestine Large, Rectum (69) (68) (70) (68) (69) Edema 2 (3%) 1 (1%) 1 (1%) Hemorrhage 1 (1%) Parasite Metazoan 6 (9%) 5 (7%) 1 (1%) 8 (12%) Intestine Large, Cecum (70) (70) (68) (68) (70) Edema 3 (4%) 2 (3%) 2 (3%) 3 (4%) 3 (4%) Parasite Metazoan 1 (1%) 2 (3%) 2 (3%) 3 (4%) Intestine Small, Duodenum (69) (70) (70) (68) (70) Epithelium, Hyperplasia 2 (3%) 4 (6%) Intestine Small, Jejunum (70) (69) (70) (67) (70) Metaplasia, Osseous 1 (1%) Epithelium, Hyperplasia 1 (1%) 1 (1%) Intestine Small, Ileum (70) (69) (69) (68) (69) Diverticulum 1 (1%) Hyperplasia, Lymphoid 1 (1%) Ulcer 1 (1%) Liver (70) (70) (70) (68) (70) Angiectasis 10 (14%) 5 (7%) 1 (1%) 4 (6%) 7 (10%) Basophilic Focus 7 (10%) 7 (10%) 3 (4%) 2 (3%) 7 (10%) Clear Cell Focus 1 (1%) 1 (1%) 3 (4%) 1 (1%) 5 (7%) Congestion 1 (1%) Degeneration, Cystic 23 (33%) 9 (13%) 16 (23%) 11 (16%) 5 (7%) Eosinophilic Focus 10 (14%) 6 (9%) 4 (6%) 1 (1%) 4 (6%) Eosinophilic Focus, Multiple 1 (1%) Fibrosis 1 (1%) 1 (1%) 1 (1%) Hematopoietic Cell Proliferation 1 (1%) 1 (1%) Hemorrhage 1 (1%) 1 (1%) Hepatodiaphragmatic Nodule 7 (10%) 4 (6%) 8 (11%) 4 (6%) 8 (11%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Subacute 1 (1%) 2 (3%) 1 (1%) 1 (1%) 2 (3%) Mixed Cell Focus 2 (3%) 2 (3%) Necrosis, Focal 8 (11%) 7 (10%) 6 (9%) 3 (4%) 2 (3%) Thrombosis 1 (1%) 1 (1%) 3 (4%) 1 (1%) Bile Duct, Cyst 2 (3%) Bile Duct, Hyperplasia 52 (74%) 47 (67%) 49 (70%) 43 (63%) 26 (37%) Centrilobular, Atrophy 1 (1%) Centrilobular, Fibrosis 1 (1%) Centrilobular, Necrosis 2 (3%) 3 (4%) 1 (1%) 2 (3%) Hepatocyte, Vacuolization Cytoplasmic 6 (9%) 10 (14%) 4 (6%) 7 (10%) 3 (4%) Kupffer Cell, Hyperplasia 1 (1%) Kupffer Cell, Pigmentation 11 (16%) 15 (21%) 18 (26%) 8 (12%) 10 (14%) Mesentery (20) (15) (11) (7) (16) Accessory Spleen 1 (5%) 2 (13%) 3 (27%) 4 (25%) Fat, Necrosis 16 (80%) 12 (80%) 7 (64%) 6 (86%) 13 (81%) Pancreas (70) (70) (69) (68) (70) Atrophy 16 (23%) 19 (27%) 19 (28%) 12 (18%) 17 (24%) Acinus, Cytoplasmic Alteration 3 (4%) 1 (1%) 1 (1%) 1 (1%) 4 (6%) Acinus, Hyperplasia, Focal 2 (3%) 1 (1%) 3 (4%) 2 (3%) 2 (3%) Salivary Glands (70) (70) (70) (68) (70) Atrophy 1 (1%) 1 (1%) Stomach, Forestomach (70) (70) (70) (68) (69) Edema 9 (13%) 2 (3%) 4 (6%) 5 (7%) 6 (9%) Erosion 2 (3%) 2 (3%) Hyperplasia 8 (11%) 7 (10%) 7 (10%) 9 (13%) 12 (17%) Inflammation, Subacute 2 (3%) Ulcer 8 (11%) 10 (14%) 1 (1%) 3 (4%) 7 (10%) Mucosa, Hyperplasia 1 (1%) 1 (1%) Stomach, Glandular (70) (70) (69) (68) (70) Edema 1 (1%) 2 (3%) 1 (1%) 3 (4%) 3 (4%) Erosion 1 (1%) 11 (16%) 3 (4%) 2 (3%) 1 (1%) Mineralization 1 (1%) 2 (3%) 5 (7%) Ulcer 3 (4%) 5 (7%) 3 (4%) 3 (4%) Tongue (1) (2) (2) (1) (4) Epithelium, Hyperplasia 1 (50%) 2 (100%) 1 (100%) 2 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (70) (70) (70) (68) (70) Hypertrophy 1 (1%) 3 (4%) 1 (1%) 4 (6%) Inflammation, Subacute 1 (1%) 1 (1%) 1 (1%) Mineralization 1 (1%) 1 (1%) Thrombosis 1 (1%) Heart (70) (70) (70) (68) (70) Cardiomyopathy 42 (60%) 42 (60%) 43 (61%) 37 (54%) 39 (56%) Mineralization 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Necrosis 1 (1%) Thrombosis 6 (9%) 9 (13%) 8 (11%) 4 (6%) Endocardium, Hyperplasia 1 (1%) Schwann Cell, Hyperplasia 1 (1%) 1 (1%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (70) (70) (70) (68) (70) Accessory Adrenal Cortical Nodule 18 (26%) 17 (24%) 10 (14%) 12 (18%) 14 (20%) Degeneration, Cystic 1 (1%) Degeneration, Fatty 9 (13%) 7 (10%) 10 (14%) 8 (12%) 7 (10%) Hemorrhage 1 (1%) 3 (4%) 2 (3%) Hyperplasia, Focal 4 (6%) 2 (3%) 2 (3%) 2 (3%) 3 (4%) Hypertrophy, Focal 6 (9%) 5 (7%) 5 (7%) 2 (3%) 2 (3%) Necrosis 1 (1%) 1 (1%) Adrenal Medulla (70) (70) (69) (68) (70) Hyperplasia 26 (37%) 30 (43%) 22 (32%) 15 (22%) 12 (17%) Islets, Pancreatic (70) (70) (69) (68) (70) Hyperplasia 3 (4%) 3 (4%) 1 (1%) 2 (3%) 1 (1%) Parathyroid Gland (65) (66) (64) (65) (66) Hyperplasia 6 (9%) 1 (2%) 8 (13%) 7 (11%) 9 (14%) Pituitary Gland (70) (69) (68) (66) (70) Nuclear Alteration 1 (1%) Pars Distalis, Angiectasis 4 (6%) 2 (3%) 2 (3%) 1 (2%) Pars Distalis, Cyst 6 (9%) 9 (13%) 3 (4%) 4 (6%) 7 (10%) Pars Distalis, Cyst, Hemorrhagic 1 (1%) 1 (2%) Pars Distalis, Hyperplasia, Focal 10 (14%) 10 (14%) 8 (12%) 8 (12%) 14 (20%) Pars Intermedia, Angiectasis 1 (1%) 2 (3%) 1 (1%) Pars Intermedia, Cyst 1 (1%) 8 (12%) 6 (9%) 5 (8%) 2 (3%) Thyroid Gland (70) (70) (70) (68) (70) Ectopic Thymus 1 (1%) 1 (1%) Ultimobranchial Cyst 2 (3%) 3 (4%) 2 (3%) 1 (1%) 8 (11%) C-Cell, Hyperplasia 9 (13%) 6 (9%) 8 (11%) 9 (13%) 7 (10%) Follicle, Cyst 1 (1%) 1 (1%) 3 (4%) 1 (1%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (70) (70) (70) (67) (70) Atypia Cellular 27 (39%) 29 (41%) 26 (37%) 28 (42%) 25 (36%) Granuloma Sperm 1 (1%) Preputial Gland (70) (70) (70) (68) (70) Cyst 3 (4%) 3 (4%) 4 (6%) 4 (6%) Hyperplasia 3 (4%) 1 (1%) 2 (3%) 4 (6%) 2 (3%) Inflammation, Chronic 26 (37%) 12 (17%) 16 (23%) 18 (26%) 12 (17%) Inflammation, Suppurative 3 (4%) 1 (1%) 7 (10%) 3 (4%) 5 (7%) Prostate (70) (70) (70) (68) (70) Cyst 1 (1%) Fibrosis 3 (4%) 1 (1%) Inflammation, Chronic 5 (7%) 2 (3%) 1 (1%) Inflammation, Suppurative 36 (51%) 29 (41%) 41 (59%) 41 (60%) 23 (33%) Epithelium, Hyperplasia 11 (16%) 12 (17%) 10 (14%) 6 (9%) 8 (11%) Testes (70) (70) (70) (67) (70) Interstitial Cell, Hyperplasia 4 (6%) 3 (4%) 7 (10%) 6 (9%) 3 (4%) Seminiferous Tubule, Atrophy 7 (10%) 1 (1%) 6 (9%) 2 (3%) 5 (7%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (70) (70) (70) (68) (70) Depletion Cellular 1 (1%) Hyperplasia 6 (9%) 5 (7%) 2 (3%) 7 (10%) Infiltration Cellular, Histiocyte 2 (3%) Myelofibrosis 4 (6%) 2 (3%) 8 (11%) 2 (3%) Lymph Node (33) (37) (37) (36) (35) Deep Cervical, Hyperplasia, Lymphoid 1 (3%) Iliac, Hemorrhage 1 (3%) Inguinal, Hyperplasia, Lymphoid 2 (6%) 1 (3%) Mediastinal, Congestion 2 (6%) Mediastinal, Hemorrhage 3 (9%) 5 (14%) 3 (8%) 3 (8%) 3 (9%) Mediastinal, Hyperplasia, Lymphoid 1 (3%) 3 (8%) 2 (5%) 1 (3%) 2 (6%) Mediastinal, Pigmentation 13 (39%) 14 (38%) 14 (38%) 17 (47%) 16 (46%) Pancreatic, Ectasia 1 (3%) Pancreatic, Hemorrhage 2 (5%) Pancreatic, Hyperplasia, Plasma Cell 1 (3%) Pancreatic, Pigmentation 9 (27%) 4 (11%) 3 (8%) 4 (11%) 3 (9%) Renal, Ectasia 2 (6%) Renal, Hemorrhage 1 (3%) 1 (3%) 1 (3%) 3 (8%) 2 (6%) Renal, Hyperplasia, Lymphoid 1 (3%) Renal, Pigmentation 8 (24%) 5 (14%) 8 (22%) 8 (22%) 7 (20%) Lymph Node, Mandibular (70) (69) (70) (68) (70) Ectasia 3 (4%) 8 (12%) 8 (11%) 7 (10%) 6 (9%) Hemorrhage 2 (3%) 1 (1%) 2 (3%) 3 (4%) Hyperplasia, Lymphoid 11 (16%) 11 (16%) 7 (10%) 10 (15%) 17 (24%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Plasma Cell 1 (1%) 1 (1%) Pigmentation 6 (9%) 8 (12%) 3 (4%) 7 (10%) 5 (7%) Lymph Node, Mesenteric (70) (68) (68) (67) (70) Ectasia 7 (10%) 1 (1%) 1 (1%) 7 (10%) 10 (14%) Hemorrhage 1 (1%) 3 (4%) 3 (4%) 1 (1%) 2 (3%) Hyperplasia, Lymphoid 3 (4%) 2 (3%) 1 (1%) 10 (15%) 6 (9%) Pigmentation 1 (1%) Spleen (70) (70) (70) (68) (70) Angiectasis 1 (1%) Congestion 1 (1%) Fibrosis 21 (30%) 19 (27%) 20 (29%) 9 (13%) 13 (19%) Hematopoietic Cell Proliferation 7 (10%) 6 (9%) 6 (9%) 3 (4%) 8 (11%) Metaplasia, Lipocyte 1 (1%) Necrosis 2 (3%) 3 (4%) 2 (3%) 3 (4%) Pigmentation, Hemosiderin 13 (19%) 11 (16%) 9 (13%) 14 (21%) 17 (24%) Lymphoid Follicle, Atrophy 1 (1%) Red Pulp, Atrophy 1 (1%) Thymus (68) (65) (65) (64) (66) Cyst 1 (2%) Ectopic Parathyroid Gland 1 (2%) 2 (3%) Hemorrhage 1 (2%) 3 (5%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (67) (68) (67) (66) (68) Dilatation 23 (34%) 27 (40%) 24 (36%) 17 (26%) 10 (15%) Galactocele 5 (7%) 4 (6%) 1 (2%) 2 (3%) Hyperplasia 7 (10%) 12 (18%) 4 (6%) 5 (8%) 6 (9%) Skin (70) (70) (70) (67) (70) Cyst Epithelial Inclusion 2 (3%) 1 (1%) 1 (1%) 1 (1%) Hemorrhage 1 (1%) Hyperkeratosis 1 (1%) 1 (1%) 2 (3%) 1 (1%) Inflammation, Chronic 1 (1%) 1 (1%) 2 (3%) Ulcer 1 (1%) 1 (1%) Epidermis, Hyperplasia 1 (1%) 1 (1%) 1 (1%) 1 (1%) 1 (1%) Subcutaneous Tissue, Inflammation, Suppurative 1 (1%) Subcutaneous Tissue, Thrombosis 1 (1%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (70) (70) (70) (68) (70) Fibrous Osteodystrophy 6 (9%) 1 (1%) 5 (7%) 5 (7%) 7 (10%) Hyperostosis 1 (1%) 1 (1%) Femur, Osteopetrosis 1 (1%) 2 (3%) 2 (3%) 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (70) (70) (68) (70) Angiectasis 1 (1%) Atrophy 12 (17%) 6 (9%) 8 (11%) 8 (12%) 3 (4%) Gliosis 1 (1%) Hemorrhage 2 (3%) 1 (1%) 1 (1%) 1 (1%) Hydrocephalus 4 (6%) 3 (4%) 3 (4%) 4 (6%) Necrosis 1 (1%) 2 (3%) 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (70) (70) (70) (68) (70) Congestion 2 (3%) Edema 1 (1%) 1 (1%) 1 (1%) Hemorrhage 3 (4%) 2 (3%) 5 (7%) 2 (3%) 2 (3%) Infiltration Cellular, Histiocyte 19 (27%) 17 (24%) 21 (30%) 10 (15%) 14 (20%) Inflammation, Subacute 4 (6%) 7 (10%) 7 (10%) 7 (10%) 8 (11%) Metaplasia, Osseous 1 (1%) Mineralization 1 (1%) 1 (1%) Alveolar Epithelium, Hyperplasia 7 (10%) 8 (11%) 10 (14%) 6 (9%) 10 (14%) Nose (70) (70) (70) (68) (70) Foreign Body 6 (9%) 5 (7%) 8 (11%) 2 (3%) 2 (3%) Inflammation, Suppurative 17 (24%) 10 (14%) 22 (31%) 15 (22%) 11 (16%) Goblet Cell, Hyperplasia 5 (7%) 4 (6%) 3 (4%) 9 (13%) 20 (29%) Mucosa, Hyperplasia 14 (20%) 8 (11%) 18 (26%) 13 (19%) 10 (14%) Mucosa, Metaplasia, Squamous 8 (11%) 4 (6%) 13 (19%) 8 (12%) 7 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (4) (4) (2) (1) (2) Atrophy 2 (50%) 1 (50%) Cataract 1 (25%) 2 (50%) 1 (50%) Inflammation, Chronic 1 (25%) 1 (50%) Retina, Degeneration 1 (25%) 2 (50%) 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (70) (70) (68) (70) Cyst 2 (3%) 1 (1%) 3 (4%) 7 (10%) 11 (16%) Developmental Malformation 1 (1%) Inflammation, Suppurative 9 (13%) 8 (11%) 9 (13%) 20 (29%) Mineralization 13 (19%) 13 (19%) 4 (6%) 2 (3%) 1 (1%) Nephropathy 65 (93%) 64 (91%) 65 (93%) 62 (91%) 66 (94%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05217-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC T-BUTYLHYDROQUINONE Date: 04/04/96 Route: DOSED FEED Time: 06:47:04 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.0% 0.125% 0.25% 0.5% CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Renal Tubule, Accumulation, Hyaline Droplet 1 (1%) 3 (4%) 1 (1%) 2 (3%) 1 (1%) Renal Tubule, Atrophy 1 (1%) 1 (1%) Renal Tubule, Hyperplasia, Focal 1 (1%) Renal Tubule, Necrosis 3 (4%) 1 (1%) 1 (1%) 1 (1%) Renal Tubule, Pigmentation 18 (26%) 23 (33%) 26 (37%) 17 (25%) 15 (21%) Transitional Epithelium, Hyperplasia 13 (19%) 2 (3%) 12 (17%) 11 (16%) 21 (30%) Urinary Bladder (70) (70) (70) (68) (70) Hemorrhage 1 (1%) 1 (1%) Inflammation, Suppurative 1 (1%) 1 (1%) Transitional Epithelium, Hyperplasia 2 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------