TDMS Study 05121-07 Pathology Tables
NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 Facility: Battelle Columbus Laboratory Chemical CAS #: 6533-68-2 Lock Date: 06/01/92 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: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 60 70 70 70 Scheduled Sacrifice 10 10 10 10 10 Early Deaths Natural Death 7 3 3 5 6 Moribund Sacrifice 9 10 11 7 7 Dosing Accident 2 1 1 Survivors Terminal Sacrifice 33 36 36 37 38 Animals Examined Microscopically 61 60 60 60 61 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (61) (60) (60) (60) (60) Perforation 1 (2%) 1 (2%) Periesophageal Tissue, Inflammation, Suppurative 3 (5%) 1 (2%) 1 (2%) 2 (3%) Intestine Large, Rectum (61) (60) (60) (60) (60) Inflammation, Chronic Active 1 (2%) Intestine Small, Duodenum (61) (60) (59) (60) (61) Ulcer 1 (2%) Intestine Small, Jejunum (61) (58) (59) (60) (60) Hyperplasia, Lymphoid 2 (3%) 2 (3%) 1 (2%) 3 (5%) Inflammation, Chronic Active 1 (2%) 1 (2%) Ulcer 1 (2%) Liver (61) (60) (60) (60) (61) Angiectasis 1 (2%) 2 (3%) 1 (2%) 1 (2%) 1 (2%) Basophilic Focus 1 (2%) 1 (2%) 2 (3%) 4 (7%) 3 (5%) Clear Cell Focus 1 (2%) 1 (2%) Developmental Malformation 1 (2%) Ectopic Tissue 1 (2%) Eosinophilic Focus 17 (28%) 4 (7%) 10 (17%) 13 (22%) 9 (15%) Fatty Change 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 1 (2%) 1 (2%) Inflammation 1 (2%) Inflammation, Chronic Active 1 (2%) Mixed Cell Focus 7 (11%) 1 (2%) 7 (12%) 3 (5%) 3 (5%) Necrosis 3 (5%) 1 (2%) 2 (3%) 2 (3%) Kupffer Cell, Pigmentation, Hemosiderin 1 (2%) Mesentery (7) (5) (9) (4) (5) Inflammation, Suppurative 2 (40%) Artery, Inflammation, Chronic Active 1 (25%) Fat, Necrosis 6 (86%) 1 (20%) 8 (89%) 2 (50%) 2 (40%) Pancreas (61) (60) (60) (60) (61) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Atrophy 6 (10%) 4 (7%) 4 (7%) 4 (7%) Hypertrophy 1 (2%) Inflammation, Chronic Active 2 (3%) Duct, Cyst 2 (3%) 3 (5%) 4 (7%) 1 (2%) Salivary Glands (60) (60) (60) (60) (61) Atrophy 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Duct, Hyperplasia 1 (2%) Stomach, Forestomach (61) (60) (60) (60) (61) Cyst 1 (2%) Diverticulum 1 (2%) Hyperplasia, Focal 8 (13%) 17 (28%) 3 (5%) 12 (20%) 14 (23%) Infiltration Cellular, Plasma Cell 1 (2%) Stomach, Glandular (61) (60) (60) (60) (61) Erosion 2 (3%) 2 (3%) Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (61) (58) (60) (60) (61) Mineralization 1 (2%) Aorta, Inflammation, Chronic Active 1 (2%) 1 (2%) Heart (61) (60) (60) (60) (61) Inflammation, Chronic Active 1 (2%) Mineralization 2 (3%) 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) 2 (3%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (61) (60) (60) (60) (61) Accessory Adrenal Cortical Nodule 1 (2%) 2 (3%) 2 (3%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 1 (2%) 1 (2%) 4 (7%) 1 (2%) Capsule, Hyperplasia, Adenomatous 1 (2%) Adrenal Medulla (61) (58) (59) (59) (60) Hyperplasia 3 (5%) 1 (2%) 2 (3%) Islets, Pancreatic (61) (60) (60) (60) (61) Hyperplasia 1 (2%) 1 (2%) 2 (3%) 1 (2%) Parathyroid Gland (58) (48) (48) (46) (53) Cyst 1 (2%) Cytoplasmic Alteration, Focal 1 (2%) Inflammation, Chronic Active 1 (2%) Pituitary Gland (60) (58) (57) (57) (56) Angiectasis 1 (2%) 1 (2%) Pars Distalis, Hyperplasia 27 (45%) 11 (19%) 15 (26%) 11 (19%) 14 (25%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (61) (60) (59) (60) (61) Inflammation, Chronic Active 1 (2%) 1 (2%) 5 (8%) 1 (2%) Follicular Cell, Hyperplasia 18 (30%) 5 (8%) 14 (24%) 10 (17%) 8 (13%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (58) (60) (56) (58) (58) Duct, Ectasia 1 (2%) 1 (2%) 1 (2%) Ovary (61) (59) (59) (59) (61) Cyst 17 (28%) 10 (17%) 17 (29%) 12 (20%) 14 (23%) Inflammation, Suppurative 2 (3%) 1 (2%) 1 (2%) Mineralization 1 (2%) Uterus (61) (60) (60) (60) (61) Angiectasis 1 (2%) 2 (3%) Hyperplasia, Cystic 43 (70%) 29 (48%) 37 (62%) 34 (57%) 27 (44%) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (61) (60) (60) (60) (61) Myelofibrosis 23 (38%) 18 (30%) 23 (38%) 15 (25%) 13 (21%) Erythroid Cell, Hyperplasia 3 (5%) 2 (3%) 3 (5%) 4 (7%) Myeloid Cell, Hyperplasia 9 (15%) 7 (12%) 5 (8%) 6 (10%) 3 (5%) Lymph Node (6) (3) (5) (4) (3) Bronchial, Inflammation, Chronic Active 1 (33%) Mediastinal, Hyperplasia, Lymphoid 1 (25%) Renal, Angiectasis 1 (20%) Lymph Node, Mandibular (59) (57) (55) (58) (61) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) Lymph Node, Mesenteric (60) (57) (56) (59) (58) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) 2 (3%) Inflammation, Chronic Active 1 (2%) Spleen (61) (60) (60) (60) (61) Depletion Lymphoid 2 (3%) 1 (2%) Hematopoietic Cell Proliferation 17 (28%) 11 (18%) 11 (18%) 17 (28%) 7 (11%) Hyperplasia, Lymphoid 3 (5%) 2 (3%) 2 (3%) 2 (3%) Hyperplasia, Plasma Cell 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Thymus (57) (53) (53) (56) (55) Atrophy 3 (5%) 2 (4%) 7 (13%) 4 (7%) 3 (5%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (61) (59) (59) (60) (61) Hyperplasia 1 (2%) 3 (5%) 2 (3%) 4 (7%) Skin (61) (60) (60) (60) (61) Cyst Epithelial Inclusion 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Ulcer 1 (2%) Subcutaneous Tissue, Fibrosis, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (61) (60) (60) (60) (61) Infarct 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Neuron, Necrosis 1 (2%) 4 (7%) 1 (2%) 2 (3%) Peripheral Nerve (2) (2) (2) Degeneration 2 (100%) 1 (50%) 1 (50%) Spinal Cord (2) (2) (2) (1) White Matter, Degeneration 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (61) (60) (60) (60) (61) Inflammation, Chronic Active 2 (3%) 2 (3%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) Trachea (61) (60) (60) (60) (61) Artery, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Internal Ear, Inflammation, Chronic Active 1 (100%) Eye (2) (2) (2) Degeneration 1 (50%) 1 (50%) Cornea, Inflammation, Chronic Active 2 (100%) Lens, Cataract 1 (50%) Retina, Atrophy 1 (50%) Harderian Gland (18) (10) (15) (16) (16) Inflammation, Chronic Active 1 (7%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (61) (60) (60) (60) (61) Cyst 1 (2%) Infarct 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) Nephropathy 28 (46%) 25 (42%) 24 (40%) 27 (45%) 12 (20%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Necrosis, Acute 1 (2%) Urinary Bladder (60) (60) (58) (59) (61) Inflammation, Chronic Active 1 (2%) Artery, Inflammation, Chronic Active 2 (3%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 60 70 70 70 Scheduled Sacrifice 10 10 10 10 10 Early Deaths Natural Death 6 6 4 5 2 Moribund Sacrifice 4 2 7 4 7 Dosing Accident 1 1 Accidently Killed 2 1 Survivors Terminal Sacrifice 40 41 39 39 39 Animals Examined Microscopically 60 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (60) (60) (60) (60) (60) Cyst 1 (2%) Periesophageal Tissue, Inflammation, Suppurative 1 (2%) 2 (3%) 1 (2%) Gallbladder (59) (60) (59) (59) (58) Inflammation, Chronic Active 1 (2%) Intestine Small, Jejunum (60) (60) (60) (59) (60) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Ulcer 1 (2%) 1 (2%) Intestine Small, Ileum (59) (60) (59) (60) (58) Amyloid Deposition 1 (2%) Liver (60) (60) (60) (60) (60) Amyloid Deposition 1 (2%) Basophilic Focus 3 (5%) 1 (2%) 4 (7%) 3 (5%) Clear Cell Focus 13 (22%) 2 (3%) 5 (8%) 3 (5%) Eosinophilic Focus 22 (37%) 14 (23%) 8 (13%) 2 (3%) Fatty Change 3 (5%) 5 (8%) 1 (2%) Hematopoietic Cell Proliferation 2 (3%) 2 (3%) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Mixed Cell Focus 6 (10%) 2 (3%) 7 (12%) 9 (15%) 1 (2%) Necrosis 1 (2%) 1 (2%) 2 (3%) 1 (2%) 3 (5%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 1 (2%) 1 (2%) Hepatocyte, Hypertrophy 1 (2%) Mesentery (5) (1) (3) (3) (2) Infiltration Cellular, Lymphocyte 1 (33%) Fat, Inflammation, Chronic Active 1 (20%) 1 (100%) 1 (33%) 1 (50%) Fat, Necrosis 2 (40%) 2 (67%) 1 (33%) Pancreas (60) (60) (60) (60) (60) Atrophy 2 (3%) 2 (3%) 2 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Atypia Cellular 1 (2%) Hyperplasia 1 (2%) Necrosis 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Duct, Cyst 1 (2%) 2 (3%) Salivary Glands (60) (60) (60) (60) (60) Atrophy 1 (2%) Stomach, Forestomach (60) (60) (60) (60) (60) Hyperplasia, Focal 3 (5%) 17 (28%) 2 (3%) 3 (5%) 8 (13%) Infiltration Cellular, Mast Cell 1 (2%) Stomach, Glandular (60) (60) (60) (60) (60) Dysplasia 1 (2%) Erosion 5 (8%) Inflammation, Chronic Active, Focal 1 (2%) Tooth (14) (4) (5) (2) Dysplasia 13 (93%) 3 (75%) 3 (60%) 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (60) (60) (60) (60) (59) Aorta, Inflammation, Chronic Active 1 (2%) Heart (60) (60) (60) (60) (60) Inflammation, Chronic Active 2 (3%) 1 (2%) Mineralization 2 (3%) Artery, Inflammation, Chronic Active 1 (2%) Artery, Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) (60) Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%) 1 (2%) 1 (2%) Hyperplasia 27 (45%) 12 (20%) 18 (30%) 20 (33%) 27 (45%) Capsule, Hyperplasia, Adenomatous 8 (13%) 7 (12%) 2 (3%) 8 (13%) 6 (10%) Adrenal Medulla (59) (60) (55) (60) (60) Hyperplasia 3 (5%) Inflammation, Chronic Active 1 (2%) Islets, Pancreatic (60) (60) (60) (60) (60) Hyperplasia 32 (53%) 3 (5%) 30 (50%) 12 (20%) 2 (3%) Parathyroid Gland (56) (51) (49) (56) (52) Hyperplasia 1 (2%) Pituitary Gland (58) (58) (56) (55) (53) Cyst 1 (2%) 1 (2%) Pars Distalis, Hyperplasia 1 (2%) 1 (2%) Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (60) (60) (60) (60) (60) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Follicular Cell, Hyperplasia 13 (22%) 1 (2%) 15 (25%) 13 (22%) 5 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (60) (60) (60) Granuloma Sperm 1 (2%) 2 (3%) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Preputial Gland (60) (60) (60) (59) (60) Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (3%) 2 (3%) 3 (5%) Duct, Ectasia 57 (95%) 56 (93%) 58 (97%) 56 (95%) 54 (90%) Prostate (59) (59) (60) (60) (60) Inflammation, Chronic Active 2 (3%) 2 (3%) Artery, Inflammation, Chronic Active 1 (2%) Seminal Vesicle (60) (60) (60) (60) (60) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Testes (60) (60) (60) (60) (60) Atrophy 2 (3%) Hypoplasia 1 (2%) Interstitial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) (60) Thrombosis 1 (2%) Erythroid Cell, Hyperplasia 5 (8%) 4 (7%) 2 (3%) Myeloid Cell, Hyperplasia 1 (2%) 1 (2%) 4 (7%) 5 (8%) 5 (8%) Lymph Node (2) (1) (2) (3) Lumbar, Hyperplasia, Lymphoid 1 (33%) Mediastinal, Hyperplasia, Lymphoid 1 (50%) Lymph Node, Mandibular (59) (59) (58) (57) (56) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) Lymph Node, Mesenteric (58) (53) (56) (56) (57) Hematopoietic Cell Proliferation 2 (3%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Inflammation, Chronic Active 1 (2%) Spleen (60) (60) (60) (60) (60) Amyloid Deposition 1 (2%) Angiectasis 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Depletion Lymphoid 5 (8%) 1 (2%) 1 (2%) 3 (5%) Hematopoietic Cell Proliferation 8 (13%) 7 (12%) 12 (20%) 14 (23%) 12 (20%) Hyperplasia, Lymphoid 1 (2%) Thymus (51) (55) (54) (50) (50) Atrophy 6 (12%) 5 (9%) 12 (22%) 4 (8%) 7 (14%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (60) (60) (60) (60) (60) Inflammation, Chronic Active 1 (2%) Ulcer 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 2 (3%) Subcutaneous Tissue, Lymphangiectasis 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) (60) Hemorrhage, Acute 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Neuron, Necrosis 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) (60) Embolus 1 (2%) Granuloma 1 (2%) Hemorrhage, Acute 1 (2%) Inflammation, Chronic Active 2 (3%) 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) Pigmentation, Hemosiderin 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 8 (13%) 5 (8%) 3 (5%) 3 (5%) 2 (3%) Nose (60) (60) (60) (60) (60) Hemorrhage, Acute 1 (2%) Inflammation, Suppurative 1 (2%) 2 (3%) Trachea (60) (60) (60) (60) (60) Peritracheal Tissue, Hemorrhage, Acute 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05121-07 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC SCOPOLAMINE HYDROBROMIDE TRIHYDRATE Date: 04/03/96 Route: GAVAGE Time: 22:04:18 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 MG/KG 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG FEED RTD ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) (1) (3) Degeneration 1 (33%) Cornea, Inflammation, Chronic Active 1 (33%) 1 (100%) 1 (33%) Cornea, Necrosis 1 (33%) Harderian Gland (20) (18) (20) (21) (16) Hyperplasia 1 (5%) Inflammation, Chronic Active 2 (10%) 2 (13%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) (60) Cyst 6 (10%) 3 (5%) 2 (3%) 3 (5%) Developmental Malformation 1 (2%) Hydronephrosis 1 (2%) Infarct 1 (2%) Inflammation, Chronic Active 2 (3%) 2 (3%) 2 (3%) Necrosis 1 (2%) 1 (2%) Nephropathy 58 (97%) 49 (82%) 55 (92%) 52 (87%) 43 (72%) Artery, Inflammation, Chronic Active 2 (3%) Glomerulus, Amyloid Deposition 1 (2%) Renal Tubule, Hyperplasia 2 (3%) Urinary Bladder (60) (60) (60) (60) (59) Inflammation, Chronic Active 2 (3%) 2 (3%) 3 (5%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------