TDMS Study 05162-09 Pathology Tables
NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 CORE STUDY Facility: Battelle Columbus Laboratory Chemical CAS #: 111-42-2 Lock Date: 05/07/93 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: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 14 5 9 13 Moribund Sacrifice 11 16 12 13 Survivors Terminal Sacrifice 25 29 29 24 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) Periesophageal Tissue, Necrosis 1 (2%) Intestine Large, Colon (50) (50) (50) (49) Mineralization 1 (2%) Parasite Metazoan 3 (6%) 3 (6%) 1 (2%) 1 (2%) Ulcer 1 (2%) 1 (2%) Intestine Large, Rectum (50) (50) (50) (50) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) Parasite Metazoan 4 (8%) 1 (2%) Ulcer 1 (2%) Intestine Large, Cecum (50) (49) (50) (49) Parasite Metazoan 1 (2%) Ulcer 1 (2%) 1 (2%) Intestine Small, Duodenum (50) (50) (50) (49) Mineralization 1 (2%) Ulcer 1 (2%) 2 (4%) Intestine Small, Ileum (49) (49) (48) (47) Muscularis, Inflammation, Chronic Active, Focal 1 (2%) Liver (50) (50) (50) (50) Basophilic Focus 40 (80%) 31 (62%) 20 (40%) 7 (14%) Clear Cell Focus 3 (6%) 2 (4%) 1 (2%) Congestion 1 (2%) Cyst 2 (4%) Degeneration, Cystic 2 (4%) Eosinophilic Focus 1 (2%) 5 (10%) 2 (4%) 3 (6%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) Hepatodiaphragmatic Nodule 2 (4%) 6 (12%) 6 (12%) 8 (16%) Mixed Cell Focus 3 (6%) 6 (12%) 1 (2%) Necrosis 1 (2%) Centrilobular, Degeneration 1 (2%) 2 (4%) Centrilobular, Necrosis 2 (4%) 1 (2%) Oval Cell, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Periportal, Degeneration 1 (2%) Portal, Fibrosis 1 (2%) Serosa, Fibrosis 1 (2%) Mesentery (4) (7) (6) (5) Angiectasis 1 (20%) Inflammation, Chronic 1 (17%) Fat, Necrosis 4 (100%) 6 (86%) 4 (67%) 3 (60%) Oral Mucosa (2) (2) (1) Gingival, Inflammation, Suppurative 2 (100%) 1 (50%) Pancreas (50) (50) (50) (50) Inflammation, Chronic 1 (2%) Necrosis 1 (2%) 1 (2%) Acinus, Atrophy 13 (26%) 21 (42%) 11 (22%) 14 (28%) Artery, Inflammation, Chronic Active 1 (2%) Salivary Glands (50) (50) (50) (50) Atrophy 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Inflammation, Chronic Active 2 (4%) Mineralization 1 (2%) Ulcer 2 (4%) 3 (6%) 5 (10%) 6 (12%) Epithelium, Hyperplasia 1 (2%) 2 (4%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) Hyperplasia 1 (2%) Mineralization 2 (4%) Ulcer 3 (6%) 2 (4%) 2 (4%) 2 (4%) Tongue (1) (1) (1) Inflammation, Suppurative 1 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (2) Mineralization 2 (100%) Heart (50) (50) (50) (50) Atrium, Thrombosis 1 (2%) 1 (2%) 4 (8%) 1 (2%) Myocardium, Degeneration 36 (72%) 33 (66%) 35 (70%) 36 (72%) Myocardium, Mineralization 3 (6%) Valve, Fibrosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Hyperplasia 13 (26%) 13 (26%) 11 (22%) 11 (22%) Hypertrophy 1 (2%) 2 (4%) 2 (4%) Necrosis, Acute 1 (2%) Thrombosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Bilateral, Hypertrophy 1 (2%) Adrenal Medulla (49) (50) (49) (50) Hyperplasia 3 (6%) 10 (20%) 4 (8%) 10 (20%) Necrosis 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 1 (2%) 1 (2%) Parathyroid Gland (43) (42) (42) (49) Hyperplasia 1 (2%) 1 (2%) Pituitary Gland (49) (50) (50) (50) Angiectasis 1 (2%) Cyst 1 (2%) Hemorrhage 1 (2%) Pars Distalis, Angiectasis 1 (2%) Pars Distalis, Degeneration, Cystic 5 (10%) 3 (6%) 2 (4%) 4 (8%) Pars Distalis, Hyperplasia 3 (6%) 11 (22%) 12 (24%) 5 (10%) Thyroid Gland (50) (50) (50) (50) C-Cell, Hyperplasia 31 (62%) 33 (66%) 39 (78%) 29 (58%) Follicular Cell, Cyst 1 (2%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) Inflammation, Chronic 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (49) (47) Fibrosis 1 (2%) Hyperplasia 4 (8%) 4 (8%) 1 (2%) 2 (4%) Inflammation, Suppurative 3 (6%) 4 (8%) 1 (2%) 1 (2%) Ovary (50) (50) (50) (50) Cyst 4 (8%) 4 (8%) 5 (10%) 8 (16%) Necrosis 1 (2%) Uterus (50) (50) (50) (50) Atrophy 1 (2%) Necrosis 1 (2%) Prolapse 1 (2%) Endometrium, Hyperplasia, Cystic 1 (2%) 1 (2%) 1 (2%) Epithelium, Hypertrophy 1 (2%) Vagina (2) (1) (1) Infiltration Cellular, Polymorphonuclear 2 (100%) Inflammation, Chronic 1 (100%) Muscularis, Hyperplasia 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Atrophy 1 (2%) Hyperplasia 2 (4%) 6 (12%) 4 (8%) 5 (10%) Myelofibrosis 1 (2%) Necrosis 1 (2%) Lymph Node, Mandibular (50) (49) (50) (48) Atrophy 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Lymph Node, Mesenteric (50) (50) (50) (49) Atrophy 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Chronic Active 1 (2%) Spleen (50) (50) (50) (50) Fibrosis 1 (2%) 3 (6%) 2 (4%) Hematopoietic Cell Proliferation 1 (2%) 3 (6%) 4 (8%) 1 (2%) Necrosis 1 (2%) Capsule, Pigmentation, Focal, Hemosiderin 1 (2%) Lymphoid Follicle, Atrophy 2 (4%) 1 (2%) 1 (2%) Lymphoid Follicle, Hyperplasia 1 (2%) Thymus (49) (49) (47) (48) Atrophy 1 (2%) Cyst 1 (2%) Infiltration Cellular, Mononuclear Cell 1 (2%) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Epidermis, Fibrosis 1 (2%) Epidermis, Skin, Site of Application, Acanthosis 1 (2%) 1 (2%) 4 (8%) 6 (12%) Epidermis, Skin, Site of Application, Exudate 1 (2%) 7 (14%) 7 (14%) 7 (14%) Epidermis, Skin, Site of Application, Hyperkeratosis 3 (6%) 13 (26%) 23 (46%) 23 (46%) Skin, Site of Application, Ulcer 2 (4%) 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 5 (10%) 2 (4%) 5 (10%) 5 (10%) Fibrosis, Focal 1 (2%) Inflammation, Granulomatous 3 (6%) 3 (6%) 5 (10%) 9 (18%) Mineralization 2 (4%) Alveolar Epithelium, Hyperplasia 2 (4%) 3 (6%) 2 (4%) 2 (4%) Interstitium, Inflammation, Chronic 2 (4%) 2 (4%) Nose (49) (50) (50) (50) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) Pleura (1) Inflammation, Chronic 1 (100%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (2) Cataract 1 (50%) 1 (50%) Degeneration 1 (50%) Anterior Chamber, Inflammation, Suppurative 1 (100%) Retina, Atrophy 1 (50%) Harderian Gland (1) Inflammation, Chronic 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 1 (2%) Nephropathy 40 (80%) 47 (94%) 48 (96%) 48 (96%) Renal Tubule, Hyperplasia 1 (2%) Renal Tubule, Mineralization 1 (2%) 1 (2%) Renal Tubule, Pigmentation, Hemosiderin 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 31 31 25 22 Natural Death 5 9 4 6 Survivors Terminal Sacrifice 14 10 21 22 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (50) (50) Parasite Metazoan 2 (4%) 3 (6%) 3 (6%) Ulcer 1 (2%) Intestine Large, Rectum (50) (50) (50) (49) Parasite Metazoan 4 (8%) 2 (4%) 4 (8%) 3 (6%) Ulcer 1 (2%) Intestine Large, Cecum (50) (50) (50) (50) Inflammation, Acute 1 (2%) Parasite Metazoan 1 (2%) Ulcer 1 (2%) 1 (2%) 1 (2%) Intestine Small, Duodenum (50) (50) (50) (50) Ulcer 3 (6%) 1 (2%) Intestine Small, Jejunum (50) (46) (48) (48) Diverticulum 1 (2%) Ulcer 1 (2%) Muscularis, Inflammation, Chronic 1 (2%) Liver (50) (50) (50) (50) Basophilic Focus 15 (30%) 5 (10%) 1 (2%) 2 (4%) Clear Cell Focus 1 (2%) 3 (6%) 2 (4%) Degeneration, Cystic 2 (4%) 2 (4%) 5 (10%) 2 (4%) Degeneration, Fatty 6 (12%) 5 (10%) 9 (18%) 7 (14%) Eosinophilic Focus 4 (8%) 2 (4%) 2 (4%) 2 (4%) Hepatodiaphragmatic Nodule 6 (12%) 1 (2%) 8 (16%) 4 (8%) Mixed Cell Focus 1 (2%) 1 (2%) Necrosis 2 (4%) 1 (2%) Bile Duct, Hyperplasia 1 (2%) Centrilobular, Degeneration 3 (6%) 1 (2%) 2 (4%) 1 (2%) Centrilobular, Necrosis 1 (2%) 1 (2%) Midzonal, Vacuolization Cytoplasmic 1 (2%) Sinusoid, Congestion 1 (2%) Mesentery (7) (4) (8) (3) Hemorrhage 1 (14%) Artery, Inflammation, Chronic 1 (13%) Artery, Thrombosis 2 (29%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Fat, Necrosis 4 (57%) 3 (75%) 4 (50%) 3 (100%) Oral Mucosa (7) (2) (2) Inflammation, Suppurative 4 (57%) 1 (50%) Gingival, Inflammation, Suppurative 2 (29%) 2 (100%) Pancreas (50) (50) (50) (50) Acinus, Atrophy 23 (46%) 18 (36%) 26 (52%) 24 (48%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) Artery, Thrombosis 1 (2%) 1 (2%) Duct, Atrophy 1 (2%) Salivary Glands (50) (49) (50) (50) Inflammation, Chronic 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Hemorrhage 1 (2%) Inflammation, Chronic 4 (8%) 1 (2%) 2 (4%) 2 (4%) Mineralization 1 (2%) 1 (2%) Ulcer 7 (14%) 8 (16%) 9 (18%) 10 (20%) Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Mineralization 4 (8%) 3 (6%) 2 (4%) 1 (2%) Ulcer 7 (14%) 4 (8%) 5 (10%) 4 (8%) Tongue (1) Inflammation, Suppurative 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (4) (3) (1) Mineralization 4 (100%) 3 (100%) Heart (50) (50) (50) (50) Degeneration, Fatty 1 (2%) Atrium, Thrombosis 2 (4%) 1 (2%) 1 (2%) 2 (4%) Myocardium, Degeneration 41 (82%) 41 (82%) 44 (88%) 45 (90%) Myocardium, Mineralization 1 (2%) 1 (2%) 1 (2%) Valve, Degeneration 1 (2%) Valve, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Atrophy 1 (2%) Hyperplasia 16 (32%) 15 (30%) 15 (30%) 12 (24%) Hypertrophy 2 (4%) Necrosis 1 (2%) Adrenal Medulla (50) (50) (50) (50) Degeneration, Cystic 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 11 (22%) 9 (18%) 15 (30%) 8 (16%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 2 (4%) 4 (8%) 5 (10%) 4 (8%) Parathyroid Gland (46) (49) (48) (47) Hyperplasia 2 (4%) 9 (18%) 1 (2%) 1 (2%) Pituitary Gland (50) (50) (50) (49) Cyst 1 (2%) Infiltration Cellular, Mononuclear Cell 1 (2%) Pigmentation, Hemosiderin 1 (2%) Pars Distalis, Degeneration, Cystic 2 (4%) 2 (4%) 2 (4%) Pars Distalis, Hyperplasia 4 (8%) 8 (16%) 7 (14%) 8 (16%) Pars Distalis, Hypoplasia 1 (2%) Thyroid Gland (50) (50) (50) (49) Cyst 1 (2%) 1 (2%) Bilateral, Follicular Cell, Cyst 1 (2%) C-Cell, Hyperplasia 33 (66%) 37 (74%) 42 (84%) 33 (67%) Follicular Cell, Cyst 2 (4%) 2 (4%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Arteriole, Inflammation, Chronic 1 (2%) Preputial Gland (50) (50) (49) (50) Hyperplasia 3 (6%) 1 (2%) 2 (4%) Inflammation, Granulomatous 2 (4%) 5 (10%) 3 (6%) Inflammation, Suppurative 1 (2%) Prostate (50) (50) (50) (50) Hyperplasia 1 (2%) Inflammation, Chronic Active 2 (4%) Inflammation, Suppurative 2 (4%) 6 (12%) 3 (6%) 4 (8%) Necrosis 1 (2%) Seminal Vesicle (50) (50) (50) (50) Atrophy 2 (4%) Fibrosis 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) Testes (50) (50) (50) (50) Germinal Epithelium, Atrophy 16 (32%) 10 (20%) 11 (22%) 9 (18%) Interstitial Cell, Hyperplasia 2 (4%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Fibrosis 1 (2%) Hyperplasia 10 (20%) 4 (8%) 7 (14%) 9 (18%) Lymph Node (4) (4) (5) (2) Mediastinal, Ectasia 1 (50%) Mediastinal, Hematopoietic Cell Proliferation 1 (25%) Renal, Infiltration Cellular, Plasma Cell 1 (20%) Lymph Node, Mandibular (49) (48) (50) (49) Atrophy 1 (2%) Erythrophagocytosis 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Acute 1 (2%) Lymph Node, Mesenteric (50) (50) (50) (50) Congestion 1 (2%) Ectasia 2 (4%) 1 (2%) 1 (2%) Erythrophagocytosis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Necrosis 1 (2%) Spleen (50) (50) (50) (50) Congestion 1 (2%) 1 (2%) 3 (6%) Fibrosis 7 (14%) 10 (20%) 9 (18%) 2 (4%) Hematopoietic Cell Proliferation 2 (4%) 3 (6%) 1 (2%) Necrosis 1 (2%) Pigmentation, Hemosiderin 3 (6%) 1 (2%) 1 (2%) Lymphoid Follicle, Atrophy 1 (2%) 2 (4%) Lymphoid Follicle, Necrosis 1 (2%) Thymus (47) (48) (48) (47) Atrophy 1 (2%) Artery, Inflammation, Chronic 1 (2%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (46) (48) (45) (42) Hyperplasia, Cystic 5 (11%) 5 (10%) 5 (11%) 1 (2%) Duct, Dilatation 1 (2%) Skin (50) (50) (50) (50) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 1 (2%) Dermis, Skin, Site of Application, Fibrosis 1 (2%) 1 (2%) Epidermis, Skin, Site of Application, Acanthosis 2 (4%) 4 (8%) 10 (20%) Epidermis, Skin, Site of Application, Degeneration 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Epidermis, Skin, Site of Application, Erosion 1 (2%) Epidermis, Skin, Site of Application, Exudate 3 (6%) 2 (4%) 7 (14%) Epidermis, Skin, Site of Application, Hyperkeratosis 3 (6%) 5 (10%) 11 (22%) Skin, Site of Application, Ulcer 2 (4%) Subcutaneous Tissue, Inflammation, Focal, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Cyst 1 (2%) Fibrous Osteodystrophy 3 (6%) 4 (8%) 4 (8%) Vertebra, Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Degeneration 1 (2%) Choroid Plexus, Thrombosis 1 (2%) Medulla, Demyelination, Focal 1 (2%) Medulla, Necrosis, Focal 2 (4%) Spinal Cord (2) (1) (1) Gliosis 1 (100%) Neuron, Degeneration 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 1 (2%) 3 (6%) Hemorrhage, Focal 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Granulomatous 5 (10%) 2 (4%) 2 (4%) Mineralization 3 (6%) 1 (2%) Alveolar Epithelium, Hyperplasia 5 (10%) 2 (4%) 2 (4%) Bronchus, Infiltration Cellular, Mononuclear Cell 1 (2%) Bronchus, Infiltration Cellular, Polymorphonuclear 1 (2%) Interstitium, Inflammation, Chronic 3 (6%) 1 (2%) 2 (4%) Nose (50) (50) (50) (49) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 2 (4%) 5 (10%) 4 (8%) 9 (18%) Glands, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05162-09 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC DIETHANOLAMINE Date: 04/08/96 Route: SKIN APPLICATION Time: 09:29:59 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (2) (2) Cataract 1 (50%) 2 (100%) Degeneration 1 (50%) Lens, Cataract 2 (100%) Harderian Gland (3) Inflammation, Acute 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Accumulation, Hyaline Droplet 1 (2%) Cyst 3 (6%) 3 (6%) 2 (4%) 2 (4%) Hydronephrosis 1 (2%) Infarct 2 (4%) Inflammation, Acute 1 (2%) Nephropathy 48 (96%) 48 (96%) 50 (100%) 48 (96%) Urinary Bladder (48) (50) (50) (50) Hemorrhage 1 (2%) Inflammation, Chronic 1 (2%) Ulcer 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------