TDMS Study 05094-03 Pathology Tables
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 Facility: Southern Research Institute Chemical CAS #: 85-68-7 Lock Date: 11/25/92 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: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 110 110 Scheduled Sacrifice 10 10 Early Deaths Dead 4 1 Moribund 11 10 Moribund Sacrifice 34 38 Natural Death 6 1 Survivors Terminal Sacrifice 10 11 Animals Examined Microscopically 110 110 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (109) (109) Edema 1 (1%) Parasite Metazoan 11 (10%) 4 (4%) Intestine Large, Rectum (108) (110) Parasite Metazoan 6 (6%) 9 (8%) Intestine Large, Cecum (110) (110) Edema 1 (1%) 1 (1%) Parasite Metazoan 1 (1%) Intestine Small, Duodenum (109) (110) Erosion 1 (1%) 1 (1%) Intestine Small, Jejunum (110) (110) Fibrosis 1 (1%) Perforation 1 (1%) Muscularis, Hyperplasia 1 (1%) Liver (110) (110) Angiectasis 5 (5%) 1 (1%) Basophilic Focus 82 (75%) 82 (75%) Clear Cell Focus 6 (5%) 3 (3%) Developmental Malformation 2 (2%) Eosinophilic Focus 21 (19%) 34 (31%) Granuloma 20 (18%) 13 (12%) Hematopoietic Cell Proliferation 3 (3%) 1 (1%) Hemorrhage 1 (1%) Hepatodiaphragmatic Nodule 7 (6%) 14 (13%) Inflammation, Subacute 5 (5%) 3 (3%) Mixed Cell Focus 17 (15%) 1 (1%) Thrombosis 2 (2%) Bile Duct, Hyperplasia 17 (15%) 16 (15%) Centrilobular, Necrosis 1 (1%) Hepatocyte, Hyperplasia, Focal 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Vacuolization Cytoplasmic 6 (5%) 1 (1%) Kupffer Cell, Pigmentation 10 (9%) 26 (24%) Lobules, Necrosis 10 (9%) 6 (5%) Mesentery (6) (5) Accessory Spleen 4 (67%) 1 (20%) Hemorrhage 1 (20%) Fat, Necrosis 2 (33%) 1 (20%) Pancreas (107) (110) Atrophy 53 (50%) 39 (35%) Acinar Cell, Hyperplasia, Focal 1 (1%) Acinus, Cytoplasmic Alteration 1 (1%) Acinus, Metaplasia, Goblet Cell 1 (1%) Salivary Glands (109) (110) Duct, Cyst 1 (1%) Stomach, Forestomach (107) (110) Edema 2 (2%) 1 (1%) Ulcer 1 (1%) 1 (1%) Mucosa, Hyperplasia 5 (5%) 4 (4%) Stomach, Glandular (108) (110) Erosion 5 (5%) 3 (3%) Mineralization 1 (1%) Ulcer 1 (1%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (109) (110) Hypertrophy 1 (1%) Thrombosis 1 (1%) Heart (110) (110) Cardiomyopathy 40 (36%) 39 (35%) Thrombosis 1 (1%) 1 (1%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (110) (110) Accessory Adrenal Cortical Nodule 23 (21%) 35 (32%) Angiectasis 55 (50%) 70 (64%) Degeneration, Fatty 27 (25%) 20 (18%) Hematopoietic Cell Proliferation 1 (1%) Hemorrhage 8 (7%) Hyperplasia, Diffuse 1 (1%) Hyperplasia, Focal 10 (9%) 8 (7%) Hypertrophy, Focal 15 (14%) 5 (5%) Necrosis 1 (1%) Adrenal Medulla (108) (110) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 13 (12%) 10 (9%) Islets, Pancreatic (107) (110) Hyperplasia 2 (2%) Metaplasia, Hepatocyte 2 (2%) Parathyroid Gland (107) (103) Angiectasis 1 (1%) Cyst 1 (1%) Pituitary Gland (110) (109) Pars Distalis, Angiectasis 16 (15%) 11 (10%) Pars Distalis, Cyst 27 (25%) 21 (19%) Pars Distalis, Hyperplasia, Focal 23 (21%) 22 (20%) Pars Intermedia, Angiectasis 3 (3%) 4 (4%) Pars Intermedia, Cyst 7 (6%) 10 (9%) Pars Intermedia, Hemorrhage 1 (1%) Thyroid Gland (109) (110) Ultimobranchial Cyst 1 (1%) C-Cell, Hyperplasia 10 (9%) 11 (10%) Follicle, Cyst 6 (6%) 2 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (110) (109) Ectasia 26 (24%) 19 (17%) Hyperplasia 5 (5%) 2 (2%) Inflammation, Chronic 6 (5%) 5 (5%) Inflammation, Suppurative 12 (11%) 5 (5%) Ovary (110) (110) Cyst 9 (8%) 12 (11%) Uterus (110) (110) Hydrometra 7 (6%) 10 (9%) Hyperplasia, Cystic 15 (14%) 24 (22%) Metaplasia, Squamous 1 (1%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (110) (110) Hypercellularity 2 (2%) 2 (2%) Hyperplasia, Reticulum Cell 1 (1%) Myelofibrosis 6 (5%) 7 (6%) Necrosis 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Lymph Node (32) (27) Iliac, Ectasia 2 (6%) Iliac, Hyperplasia, Lymphoid 2 (6%) Inguinal, Hyperplasia, Lymphoid 1 (3%) Mediastinal, Hemorrhage 3 (9%) 2 (7%) Mediastinal, Hyperplasia, Lymphoid 1 (4%) Mediastinal, Pigmentation 11 (34%) 3 (11%) Pancreatic, Pigmentation 3 (9%) 7 (26%) Renal, Hemorrhage 1 (3%) 1 (4%) Renal, Pigmentation 2 (6%) 6 (22%) Lymph Node, Mandibular (109) (110) Ectasia 6 (6%) 9 (8%) Hemorrhage 11 (10%) 17 (15%) Hyperplasia, Lymphoid 1 (1%) 6 (5%) Pigmentation 34 (31%) 29 (26%) Lymph Node, Mesenteric (110) (110) Hemorrhage 4 (4%) 5 (5%) Hyperplasia, Lymphoid 2 (2%) 2 (2%) Spleen (110) (110) Fibrosis 9 (8%) 9 (8%) Hematopoietic Cell Proliferation 29 (26%) 17 (15%) Hemorrhage 2 (2%) 1 (1%) Necrosis 1 (1%) Pigmentation, Hemosiderin 48 (44%) 51 (46%) Thymus (109) (106) Atrophy 1 (1%) Cyst 1 (1%) Hemorrhage 1 (1%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (109) (109) Ectasia 38 (35%) 17 (16%) Galactocele 3 (3%) Hyperplasia 40 (37%) 50 (46%) Skin (110) (109) Acanthosis 5 (5%) 11 (10%) Cyst Epithelial Inclusion 1 (1%) Edema 2 (2%) Hyperkeratosis 3 (3%) 2 (2%) Inflammation, Chronic 1 (1%) 1 (1%) Ulcer 3 (3%) 8 (7%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (110) (110) Cranium, Osteopetrosis 18 (16%) 11 (10%) Femur, Osteopetrosis 14 (13%) 13 (12%) Rib, Osteopetrosis 1 (1%) 1 (1%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (110) (109) Compression 19 (17%) 12 (11%) Hemorrhage 1 (1%) 3 (3%) Hydrocephalus 4 (4%) 4 (4%) Inflammation, Chronic 1 (1%) Necrosis 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (110) (110) Congestion 3 (3%) Edema 1 (1%) 1 (1%) Hemorrhage 3 (3%) 1 (1%) Infiltration Cellular, Histiocyte 34 (31%) 44 (40%) Inflammation, Subacute 2 (2%) 1 (1%) Alveolar Epithelium, Hyperplasia 9 (8%) 2 (2%) Nose (110) (110) Exudate 6 (5%) 9 (8%) Foreign Body 2 (2%) 1 (1%) Fungus 2 (2%) 2 (2%) Mucosa, Hyperplasia 5 (5%) 6 (5%) Mucosa, Metaplasia, Squamous 3 (3%) 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (5) (4) Atrophy 1 (20%) Cataract 3 (60%) 4 (100%) Retina, Degeneration 3 (60%) 4 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 2.4% CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (110) (110) Calculus Micro Observation Only 1 (1%) 17 (15%) Cyst 2 (2%) Hydronephrosis 1 (1%) Inflammation, Suppurative 2 (2%) Mineralization 101 (92%) 73 (66%) Nephropathy 90 (82%) 105 (95%) Papilla, Necrosis 3 (3%) Renal Tubule, Atrophy 9 (8%) Renal Tubule, Dilatation 18 (16%) Renal Tubule, Hyperplasia 1 (1%) 1 (1%) Renal Tubule, Necrosis 1 (1%) Renal Tubule, Pigmentation 106 (96%) 108 (98%) Transitional Epithelium, Hyperplasia 3 (3%) 49 (45%) Urinary Bladder (109) (110) Calculus Micro Observation Only 1 (1%) Transitional Epithelium, Hyperplasia 30 (27%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 110 110 Scheduled Sacrifice 10 10 Early Deaths Moribund 14 17 Accidently Killed 1 Dead 1 2 Moribund Sacrifice 37 29 Natural Death 3 8 Survivors Terminal Sacrifice 10 13 Animals Examined Microscopically 110 110 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (108) (106) Edema 1 (1%) Parasite Metazoan 9 (8%) 9 (8%) Intestine Large, Rectum (110) (108) Parasite Metazoan 11 (10%) 11 (10%) Intestine Large, Cecum (108) (109) Edema 4 (4%) 9 (8%) Parasite Metazoan 1 (1%) Ulcer 1 (1%) 1 (1%) Liver (110) (109) Angiectasis 3 (3%) 4 (4%) Basophilic Focus 24 (22%) 27 (25%) Clear Cell Focus 2 (2%) 10 (9%) Congestion 2 (2%) Cyst 1 (1%) Degeneration, Cystic 5 (5%) 2 (2%) Developmental Malformation 4 (4%) Eosinophilic Focus 9 (8%) 13 (12%) Granuloma 2 (2%) 4 (4%) Hematopoietic Cell Proliferation 4 (4%) Hepatodiaphragmatic Nodule 5 (5%) 9 (8%) Inflammation, Subacute 2 (2%) 2 (2%) Mixed Cell Focus 1 (1%) 2 (2%) Thrombosis 2 (2%) 1 (1%) Bile Duct, Hyperplasia 68 (62%) 45 (41%) Centrilobular, Necrosis 1 (1%) Hepatocyte, Hyperplasia, Focal 1 (1%) 1 (1%) Hepatocyte, Vacuolization Cytoplasmic 8 (7%) 4 (4%) Kupffer Cell, Hyperplasia 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Kupffer Cell, Pigmentation 8 (7%) 11 (10%) Lobules, Necrosis 6 (5%) 8 (7%) Mesentery (22) (19) Accessory Spleen 3 (14%) 4 (21%) Fat, Necrosis 17 (77%) 12 (63%) Pancreas (110) (109) Atrophy 70 (64%) 63 (58%) Edema 1 (1%) Inflammation, Chronic 1 (1%) Acinus, Cytoplasmic Alteration 3 (3%) 3 (3%) Acinus, Hyperplasia, Focal 5 (5%) Salivary Glands (110) (109) Atrophy 1 (1%) Stomach, Forestomach (110) (110) Edema 2 (2%) 1 (1%) Hyperplasia, Squamous 1 (1%) Mineralization 1 (1%) Ulcer 2 (2%) 2 (2%) Mucosa, Hyperplasia 4 (4%) 3 (3%) Stomach, Glandular (110) (109) Edema 2 (2%) 1 (1%) Erosion 6 (5%) 8 (7%) Mineralization 1 (1%) Ulcer 4 (4%) 1 (1%) Tongue (2) (1) Inflammation, Suppurative 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (110) (110) Cardiomyopathy 60 (55%) 65 (59%) Inflammation, Chronic 2 (2%) Thrombosis 7 (6%) 5 (5%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (110) (110) Accessory Adrenal Cortical Nodule 35 (32%) 36 (33%) Angiectasis 48 (44%) 51 (46%) Cyst 2 (2%) Degeneration, Fatty 18 (16%) 7 (6%) Hematopoietic Cell Proliferation 1 (1%) 1 (1%) Hemorrhage 2 (2%) Hyperplasia, Focal 18 (16%) 5 (5%) Hypertrophy, Focal 7 (6%) 5 (5%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Metaplasia, Osseous 1 (1%) Necrosis 1 (1%) Thrombosis 4 (4%) 1 (1%) Adrenal Medulla (110) (110) Hyperplasia 23 (21%) 12 (11%) Necrosis 1 (1%) Islets, Pancreatic (110) (109) Hyperplasia 1 (1%) 2 (2%) Pituitary Gland (106) (105) Pars Distalis, Angiectasis 4 (4%) 2 (2%) Pars Distalis, Cyst 18 (17%) 14 (13%) Pars Distalis, Hyperplasia, Focal 24 (23%) 16 (15%) Pars Intermedia, Angiectasis 3 (3%) Pars Intermedia, Cyst 7 (7%) 4 (4%) Thyroid Gland (110) (110) C-Cell, Hyperplasia 14 (13%) 9 (8%) Follicle, Cyst 4 (4%) 2 (2%) Follicular Cell, Hyperplasia 2 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (110) (110) Atypia Cellular 70 (64%) 59 (54%) Hypospermia 77 (70%) 84 (76%) Preputial Gland (110) (110) Ectasia 30 (27%) 25 (23%) Hyperplasia 1 (1%) 1 (1%) Inflammation, Chronic 52 (47%) 38 (35%) Inflammation, Suppurative 21 (19%) 15 (14%) Prostate (109) (110) Corpora Amylacea 46 (42%) 59 (54%) Edema 1 (1%) Inflammation, Suppurative 52 (48%) 40 (36%) Epithelium, Hyperplasia 17 (16%) 13 (12%) Seminal Vesicle (110) (108) Dilatation 1 (1%) Testes (110) (110) Interstitial Cell, Hyperplasia 22 (20%) 17 (15%) Seminiferous Tubule, Atrophy 10 (9%) 9 (8%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (110) (110) Hypercellularity 3 (3%) 4 (4%) Hyperplasia, Reticulum Cell 1 (1%) Myelofibrosis 9 (8%) 7 (6%) Lymph Node (42) (42) Deep Cervical, Hemorrhage 1 (2%) Iliac, Hemorrhage 1 (2%) Inguinal, Pigmentation 1 (2%) Mediastinal, Hemorrhage 3 (7%) 4 (10%) Mediastinal, Pigmentation 19 (45%) 10 (24%) Pancreatic, Ectasia 1 (2%) Pancreatic, Hemorrhage 1 (2%) 1 (2%) Pancreatic, Necrosis 1 (2%) Pancreatic, Pigmentation 11 (26%) 9 (21%) Renal, Pigmentation 6 (14%) 3 (7%) Lymph Node, Mandibular (107) (106) Ectasia 10 (9%) 4 (4%) Hemorrhage 12 (11%) 13 (12%) Hyperplasia, Lymphoid 7 (7%) 4 (4%) Pigmentation 21 (20%) 15 (14%) Lymph Node, Mesenteric (110) (109) Ectasia 2 (2%) 1 (1%) Hemorrhage 2 (2%) 3 (3%) Hyperplasia, Lymphoid 5 (5%) 1 (1%) Pigmentation 1 (1%) Spleen (110) (109) Developmental Malformation 1 (1%) Fibrosis 16 (15%) 23 (21%) Hematopoietic Cell Proliferation 13 (12%) 8 (7%) Infiltration Cellular, Histiocyte 1 (1%) Inflammation, Chronic 1 (1%) Metaplasia, Lipocyte 1 (1%) Necrosis 1 (1%) 2 (2%) Pigmentation, Hemosiderin 14 (13%) 8 (7%) Lymphoid Follicle, Hyperplasia 1 (1%) Thymus (102) (103) Ectopic Parathyroid Gland 1 (1%) Hemorrhage 1 (1%) 1 (1%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (104) (108) Hyperplasia 17 (16%) 18 (17%) Skin (109) (108) Acanthosis 4 (4%) 7 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Cyst Epithelial Inclusion 2 (2%) 2 (2%) Hemorrhage 1 (1%) 1 (1%) Hyperkeratosis 5 (5%) 7 (6%) Inflammation, Chronic 1 (1%) 3 (3%) Inflammation, Chronic Active 1 (1%) Ulcer 3 (3%) 1 (1%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (110) (110) Cranium, Osteopetrosis 3 (3%) 2 (2%) Femur, Osteopetrosis 2 (2%) 3 (3%) Rib, Osteopetrosis 1 (1%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (110) (109) Compression 3 (3%) 5 (5%) Hydrocephalus 4 (4%) 2 (2%) Necrosis 3 (3%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (110) (110) Congestion 1 (1%) Edema 2 (2%) 1 (1%) Hemorrhage 1 (1%) 1 (1%) Infiltration Cellular, Histiocyte 13 (12%) 24 (22%) Inflammation, Subacute 1 (1%) 2 (2%) Inflammation, Suppurative 1 (1%) Alveolar Epithelium, Hyperplasia 11 (10%) 6 (5%) Nose (110) (110) Exudate 21 (19%) 14 (13%) Foreign Body 8 (7%) 3 (3%) Fungus 15 (14%) 9 (8%) Mucosa, Hyperplasia 14 (13%) 8 (7%) Mucosa, Metaplasia, Squamous 15 (14%) 6 (5%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96 Route: DOSED FEED Time: 14:12:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 1.2% CONTROL ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Hemorrhage 1 (100%) Inflammation, Chronic 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (110) (109) Calculus Micro Observation Only 2 (2%) 1 (1%) Congestion 1 (1%) Cyst 2 (2%) 3 (3%) Hydronephrosis 1 (1%) Mineralization 11 (10%) 10 (9%) Nephropathy 100 (91%) 104 (95%) Thrombosis 1 (1%) 2 (2%) Renal Tubule, Atrophy 1 (1%) 3 (3%) Renal Tubule, Dilatation 4 (4%) 8 (7%) Renal Tubule, Hyperplasia 1 (1%) Renal Tubule, Necrosis 5 (5%) 5 (5%) Renal Tubule, Pigmentation 105 (95%) 104 (95%) Transitional Epithelium, Hyperplasia 3 (3%) 3 (3%) Urinary Bladder (110) (110) Hemorrhage 3 (3%) Transitional Epithelium, Hyperplasia 1 (1%) 3 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------