NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 FINAL #1/MICE Facility: Battelle Columbus Laboratory Chemical CAS #: 102-71-6 Lock Date: 05/31/01 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 b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 1 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 FEMALE 0 MG/KG 100 300 1000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Natural Death 7 6 4 7 Moribund Sacrifice 8 10 5 10 Accidently Killed 1 Survivors Terminal Sacrifice 34 34 41 32 Natural Death 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (50) (50) (50) Serosa, Inflammation, Chronic 1 [3.0] Intestine Small, Duodenum (50) (50) (50) (50) Epithelium, Necrosis 1 [1.0] Intestine Small, Jejunum (50) (50) (50) (50) Diverticulum 1 [2.0] Ulcer 1 [3.0] Peyer's Patch, Hyperplasia 1 [4.0] Peyer's Patch, Inflammation, Suppurative 1 [3.0] Serosa, Inflammation, Granulomatous 1 [2.0] Liver (50) (50) (50) (50) Angiectasis, Focal 1 [1.0] Basophilic Focus 4 3 3 Clear Cell Focus 4 3 3 5 Eosinophilic Focus 16 22 28 32 Fibrosis, Focal 1 [2.0] Hematopoietic Cell Proliferation 4 [1.0] 3 [1.7] 3 [1.7] 4 [2.8] Hepatodiaphragmatic Nodule 2 [1.0] Infiltration Cellular, Lymphoid 26 [1.0] 30 [1.2] 36 [1.2] 20 [1.1] Inflammation, Chronic 14 [1.0] 27 [1.0] 22 [1.0] 15 [1.0] Mixed Cell Focus 5 8 14 11 Necrosis, Focal 5 [1.4] 1 [1.0] 3 [2.3] Vacuolization Cytoplasmic, Focal 8 [1.3] 1 [1.0] 6 [1.0] 6 [1.2] Centrilobular, Cytomegaly, Diffuse 1 [3.0] Centrilobular, Necrosis 1 [2.0] 1 [3.0] Mesentery (11) (6) (4) (9) Inflammation, Chronic 1 [2.0] Fat, Necrosis 10 [2.5] 6 [2.2] 3 [2.3] 9 [2.3] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 2 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 FEMALE 0 MG/KG 100 300 1000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Lymphatic, Angiectasis 1 [2.0] Oral Mucosa (26) (26) (31) (31) Inflammation, Chronic 26 [1.5] 26 [1.7] 31 [1.7] 31 [1.5] Pancreas (50) (50) (50) (50) Acinus, Atrophy 1 [4.0] 3 [3.3] 1 [2.0] Acinus, Hyperplasia 1 [2.0] Duct, Cyst 1 [3.0] 2 [3.5] 1 [4.0] Stomach, Forestomach (50) (50) (50) (50) Inflammation, Chronic 1 [2.0] 1 [2.0] Inflammation, Suppurative 1 [2.0] Ulcer 1 [1.0] 2 [1.5] Epithelium, Cyst 1 [2.0] Epithelium, Hyperplasia, Focal 1 [2.0] 1 [3.0] Epithelium, Mineralization 1 [1.0] Stomach, Glandular (50) (50) (50) (50) Inflammation, Acute 1 [1.0] Ulcer 1 [2.0] 1 [2.0] Epithelium, Cyst 1 [1.0] 1 [1.0] Epithelium, Hyperplasia, Focal 1 [2.0] 1 [2.0] 1 [3.0] Serosa, Inflammation, Chronic 1 [2.0] Tooth (1) Inflammation, Chronic 1 [2.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) Aorta, Inflammation, Chronic 2 [1.0] Aorta, Mineralization 1 [2.0] 2 [3.0] Heart (50) (50) (50) (50) Artery, Inflammation, Chronic 3 [1.0] 1 [1.0] 2 [2.0] 1 [1.0] Atrium, Thrombosis 2 [4.0] Myocardium, Degeneration 4 [2.0] 1 [3.0] Myocardium, Inflammation, Acute 1 [1.0] Myocardium, Inflammation, Chronic 1 [1.0] Myocardium, Mineralization 1 [1.0] 2 [2.5] Myocardium, Necrosis 1 [3.0] Pericardium, Inflammation, Chronic 1 [2.0] Valve, Inflammation 1 [4.0] ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 3 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 FEMALE 0 MG/KG 100 300 1000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Adrenal Cortex (50) (50) (50) (50) Hematopoietic Cell Proliferation 1 [3.0] Hyperplasia, Focal 1 [1.0] 1 [1.0] Hypertrophy, Focal 2 [2.0] 1 [1.0] 1 [1.0] Inflammation, Suppurative 1 [1.0] Subcapsular, Hyperplasia 49 [1.7] 49 [2.0] 50 [1.9] 50 [1.9] Adrenal Medulla (49) (50) (50) (50) Hyperplasia, Focal 1 [2.0] 1 [2.0] Infiltration Cellular, Histiocyte 1 [2.0] Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 25 [1.3] 18 [1.4] 20 [1.5] 18 [1.3] Parathyroid Gland (39) (41) (45) (46) Cyst 1 [2.0] Pituitary Gland (50) (50) (50) (50) Angiectasis 1 [4.0] Pars Distalis, Hyperplasia 11 [1.5] 3 [2.0] 9 [1.8] 12 [1.6] Pars Intermedia, Hyperplasia 1 [2.0] Thyroid Gland (50) (50) (50) (50) Inflammation, Granulomatous 1 [1.0] 1 [1.0] C-Cell, Hyperplasia 2 [2.0] Follicle, Cyst 1 [2.0] 1 [2.0] 2 [1.5] 1 [2.0] Follicular Cell, Necrosis 1 [1.0] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (49) (49) (49) Cyst 2 [1.0] 1 [2.0] Inflammation, Suppurative 1 [2.0] Ovary (50) (50) (50) (50) Angiectasis 2 [2.0] 2 [2.0] Cyst 27 [1.7] 22 [2.0] 21 [2.0] 25 [2.0] Mineralization 1 [2.0] Thrombosis 1 [2.0] 3 [4.0] 1 [4.0] Uterus (50) (50) (50) (50) Angiectasis 1 [2.0] 2 [2.5] 2 [3.0] 2 [2.5] Thrombosis 1 [3.0] 1 [4.0] Endometrium, Hyperplasia, Cystic 49 [2.5] 48 [2.3] 47 [2.7] 47 [2.8] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 4 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 FEMALE 0 MG/KG 100 300 1000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Fibrosis 1 [1.0] Myeloid Cell, Hyperplasia 1 [4.0] Lymph Node (6) (7) (4) (6) Deep Cervical, Hyperplasia, Lymphoid 1 [4.0] Iliac, Hyperplasia, Lymphoid 1 [3.0] 1 [4.0] Lumbar, Hyperplasia, Lymphoid 1 [3.0] 1 [4.0] Lumbar, Inflammation, Acute 1 [3.0] Mediastinal, Hyperplasia, Lymphoid 1 [2.0] 1 [3.0] 2 [2.5] Renal, Hyperplasia, Lymphoid 1 [4.0] Lymph Node, Mandibular (49) (50) (50) (50) Hematopoietic Cell Proliferation 1 [2.0] Hyperplasia, Lymphoid 1 [3.0] 2 [3.0] Lymph Node, Mesenteric (50) (49) (48) (48) Hyperplasia, Histiocytic 1 [3.0] Spleen (50) (50) (49) (50) Atrophy 1 [2.0] 2 [3.0] 1 [3.0] 1 [4.0] Hematopoietic Cell Proliferation 32 [1.8] 24 [1.5] 30 [1.5] 33 [1.6] Hyperplasia, Lymphoid 1 [1.0] Thymus (49) (49) (49) (49) Atrophy 13 [2.5] 17 [2.7] 19 [2.5] 16 [2.6] Hyperplasia, Focal 1 [2.0] Hyperplasia, Histiocytic 1 [4.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Duct, Dilatation 1 [1.0] 1 [1.0] Skin (50) (50) (50) (50) Epidermis, Hyperkeratosis 1 [1.0] Epidermis, Hyperplasia 1 [1.0] Epidermis, Inflammation, Suppurative 1 [2.0] Epidermis, Ulcer 1 [4.0] Site of Application - Epidermis, Hyperkeratosis 3 [1.0] Site of Application - Epidermis, Hyperplasia 14 [1.3] 50 [1.9] 46 [2.0] 50 [2.0] Site of Application - Epidermis, Inflammation, Suppurative 1 [2.0] 2 [2.0] 20 [1.5] 32 [2.2] Site of Application - Epidermis, Ulcer 1 [3.0] 1 [3.0] 6 [1.5] 17 [1.6] Subcutaneous Tissue, Edema 1 [3.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 5 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 FEMALE 0 MG/KG 100 300 1000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Subcutaneous Tissue, Fibrosis 1 [3.0] Subcutaneous Tissue, Inflammation, Chronic 1 [4.0] Subcutaneous Tissue, Necrosis 1 [2.0] Subcutaneous Tissue, Site of Application - Dermis, Inflammation, Chronic 4 [1.8] 27 [1.1] 31 [1.6] 44 [1.8] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrosis 7 [1.1] 6 [2.0] 13 [1.5] 10 [1.1] Fracture 1 [1.0] Hyperostosis 1 [2.0] Cranium, Callus 1 [2.0] Femur, Hyperostosis 1 [2.0] ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (49) (50) Cyst Epithelial Inclusion 1 [1.0] Hydrocephalus 1 [1.0] Artery, Inflammation, Chronic 1 [2.0] Artery, Meninges, Inflammation, Chronic 1 [2.0] Hypothalamus, Compression 3 [3.7] 1 [4.0] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Inflammation, Acute 1 [4.0] Inflammation, Chronic 2 [1.0] 3 [1.0] 1 [1.0] Inflammation, Granulomatous 1 [1.0] Mineralization 2 [3.0] Alveolar Epithelium, Hyperplasia, Focal 1 [1.0] 1 [1.0] Bronchus, Hyperplasia, Focal 1 [1.0] Bronchus, Hyperplasia, Lymphoid 1 [2.0] Mediastinum, Inflammation, Chronic 1 [3.0] Serosa, Inflammation, Chronic 1 [3.0] Nose (50) (50) (50) (50) Inflammation, Chronic 1 [1.0] Sinus, Inflammation, Suppurative 1 [2.0] ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 6 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 FEMALE 0 MG/KG 100 300 1000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (49) (50) (50) (50) Degeneration 1 [1.0] Inflammation, Chronic 1 [3.0] Harderian Gland (49) (50) (50) (50) Hyperplasia 4 [2.0] 3 [3.0] 4 [2.0] 5 [2.6] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Hydronephrosis 1 [2.0] Infarct 1 [1.0] 5 [1.4] 3 [1.0] 3 [1.0] Metaplasia, Osseous 1 [1.0] 3 [1.0] Nephropathy 24 [1.0] 18 [1.1] 23 [1.0] 20 [1.1] Glomerulus, Amyloid Deposition 2 [3.0] Glomerulus, Cyst 1 [2.0] Papilla, Necrosis 1 [1.0] 1 [2.0] 1 [2.0] Papilla, Renal Tubule, Atrophy 1 [1.0] Pelvis, Inflammation, Granulomatous 1 [1.0] Renal Tubule, Cyst 1 [1.0] Renal Tubule, Cytoplasmic Alteration 1 [4.0] Renal Tubule, Mineralization 1 [2.0] Urinary Bladder (50) (50) (49) (49) Cyst 1 [3.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 7 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 MALE 0 MG/KG 200 630 2000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 Early Deaths Moribund Sacrifice 5 2 6 8 Natural Death 8 5 10 2 Survivors Terminal Sacrifice 37 43 34 40 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (48) (49) (50) (47) Necrosis 1 [4.0] Intestine Large, Colon (50) (50) (50) (50) Inflammation, Chronic 1 [3.0] Goblet Cell, Hyperplasia 1 [4.0] Intestine Large, Cecum (50) (50) (50) (50) Hemorrhage 1 [4.0] Intestine Small, Duodenum (50) (50) (50) (50) Epithelium, Hyperplasia 1 [2.0] Intestine Small, Jejunum (50) (50) (50) (50) Diverticulum 1 [1.0] Epithelium, Hyperplasia 1 [2.0] Peyer's Patch, Hyperplasia, Lymphoid 1 [1.0] 1 [2.0] Serosa, Inflammation, Granulomatous 1 [3.0] Intestine Small, Ileum (50) (50) (50) (50) Muscularis, Infiltration Cellular, Mononuclear Cell 1 [2.0] Liver (50) (50) (50) (50) Basophilic Focus 2 6 3 2 Clear Cell Focus 19 23 14 11 Eosinophilic Focus 9 20 31 30 Fibrosis 1 [1.0] Hematopoietic Cell Proliferation 3 [1.0] 4 [1.3] 1 [1.0] 2 [1.5] Hepatodiaphragmatic Nodule 1 1 Infiltration Cellular, Lymphoid 3 [1.0] 2 [1.5] 2 [1.5] 3 [1.0] Inflammation, Acute 1 [2.0] Inflammation, Chronic 9 [1.0] 14 [1.1] 10 [1.0] 11 [1.0] Mixed Cell Focus 13 11 15 8 Necrosis, Focal 4 [1.8] 3 [1.3] 7 [2.0] 6 [1.3] Vacuolization Cytoplasmic, Focal 2 [1.0] 1 [1.0] 3 [1.0] 5 [1.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 8 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 MALE 0 MG/KG 200 630 2000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Centrilobular, Necrosis 1 [2.0] 1 [3.0] Mesentery (3) (3) (5) (7) Inflammation, Granulomatous 1 [1.0] Artery, Inflammation, Chronic 1 [3.0] Fat, Necrosis 3 [2.0] 3 [2.7] 4 [2.3] 5 [1.8] Oral Mucosa (31) (26) (35) (30) Inflammation, Chronic 31 [1.9] 26 [1.9] 35 [1.8] 30 [1.7] Pancreas (50) (50) (50) (50) Acinus, Atrophy 1 [1.0] Duct, Cyst 1 [3.0] Stomach, Forestomach (50) (50) (50) (50) Inflammation, Suppurative 1 [2.0] Ulcer 1 [2.0] 1 [2.0] Epithelium, Cyst 1 [2.0] Epithelium, Hyperplasia, Focal 3 [2.0] 3 [1.7] 2 [1.5] Stomach, Glandular (50) (50) (50) (50) Hyperplasia, Lymphoid 1 [2.0] Ulcer 2 [2.0] Epithelium, Hyperplasia, Focal 1 [2.0] Glands, Ectasia 1 [1.0] Tooth (19) (18) (14) (13) Malformation 19 [2.2] 18 [1.8] 14 [2.0] 13 [1.3] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) Aorta, Inflammation, Chronic 1 [1.0] Aorta, Mineralization 1 [2.0] Pulmonary Vein, Thrombosis 1 [2.0] Heart (50) (50) (50) (50) Infiltration Cellular, Mononuclear Cell 3 [1.0] 1 [2.0] Inflammation, Acute 1 [3.0] Inflammation, Chronic 2 [1.5] Artery, Inflammation, Chronic 1 [1.0] 3 [2.0] Atrium, Thrombosis 1 [4.0] 1 [4.0] Coronary Artery, Inflammation, Chronic 1 [2.0] Myocardium, Degeneration 1 [2.0] Myocardium, Mineralization 1 [1.0] 1 [1.0] 2 [1.0] Valve, Inflammation, Chronic 1 [3.0] Ventricle, Thrombosis 1 [1.0] ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 9 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 MALE 0 MG/KG 200 630 2000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Hyperplasia, Focal 8 [1.5] 4 [1.5] 3 [1.0] 1 [1.0] Hypertrophy, Focal 16 [1.6] 21 [1.3] 10 [1.2] 10 [1.3] Necrosis 1 [3.0] Subcapsular, Hyperplasia 39 [1.2] 45 [1.2] 40 [1.5] 40 [1.3] Zona Glomerulosa, Hyperplasia 2 [2.5] 3 [2.0] 1 [1.0] Adrenal Medulla (50) (50) (50) (50) Hyperplasia, Focal 2 [2.0] Necrosis 1 [3.0] Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 45 [2.2] 43 [2.0] 43 [1.9] 32 [1.6] Pituitary Gland (50) (49) (49) (50) Pars Distalis, Hyperplasia 1 [2.0] 2 [1.0] 1 [3.0] Pars Intermedia, Hyperplasia 1 [2.0] 3 [2.3] Thyroid Gland (50) (50) (49) (50) Follicle, Cyst 1 [1.0] 1 [1.0] 1 [3.0] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (1) (1) Cyst 1 [1.0] Epididymis (50) (50) (50) (50) Granuloma Sperm 1 [3.0] 1 [2.0] 2 [2.0] Inflammation, Chronic 1 [1.0] Preputial Gland (50) (50) (50) (50) Atrophy 1 [2.0] Cyst 10 [1.9] 14 [2.1] 11 [2.1] 15 [2.1] Inflammation, Chronic 1 [2.0] 2 [1.5] Inflammation, Suppurative 1 [2.0] 3 [2.7] Prostate (50) (50) (50) (50) Hyperplasia 1 [2.0] Seminal Vesicle (50) (50) (50) (50) Atrophy 1 [2.0] Hyperplasia 1 [1.0] 2 [1.0] 2 [2.0] Testes (50) (50) (50) (50) Inflammation, Granulomatous 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 10 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 MALE 0 MG/KG 200 630 2000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Germinal Epithelium, Atrophy 4 [1.3] 2 [1.0] 1 [1.0] 2 [1.0] Germinal Epithelium, Mineralization 2 [1.5] 1 [1.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mesenteric (50) (48) (48) (50) Congestion 1 [3.0] Hyperplasia, Lymphoid 1 [4.0] Spleen (49) (50) (50) (50) Atrophy 4 [3.5] 1 [3.0] 1 [2.0] Hematopoietic Cell Proliferation 14 [1.6] 20 [1.5] 17 [1.7] 19 [1.5] Lymphoid Follicle, Hematopoietic Cell Proliferation 1 [1.0] 1 [2.0] Red Pulp, Infiltration Cellular, Mononuclear Cell 1 [2.0] Thymus (48) (47) (48) (48) Atrophy 38 [2.8] 37 [2.3] 37 [2.4] 38 [2.3] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Dermis, Edema 1 [3.0] Epidermis, Hyperkeratosis 1 [1.0] Epidermis, Ulcer 1 [3.0] Site of Application - Epidermis, Hyperkeratosis 3 [1.0] Site of Application - Epidermis, Hyperplasia 5 [1.2] 44 [1.5] 45 [2.0] 49 [2.7] Site of Application - Epidermis, Inflammation, Suppurative 1 [1.0] 11 [1.5] 33 [1.7] 42 [2.8] Site of Application - Epidermis, Ulcer 3 [1.0] 20 [1.4] 47 [2.6] Subcutaneous Tissue, Site of Application - Dermis, Inflammation, Chronic 1 [1.0] 15 [1.1] 40 [1.6] 49 [2.5] ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrosis 1 [2.0] ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 11 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 MALE 0 MG/KG 200 630 2000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Compression 1 [3.0] Spinal Cord (1) Necrosis 1 [3.0] ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Infiltration Cellular, Lymphoid 1 [2.0] Inflammation, Acute 1 [3.0] Inflammation, Chronic 1 [2.0] Inflammation, Granulomatous 2 [1.0] Alveolar Epithelium, Hyperplasia, Focal 2 [1.0] 2 [1.5] 1 [1.0] 2 [1.5] Bronchus, Hyperplasia, Focal 1 [2.0] Perivascular, Infiltration Cellular, Lymphoid 1 [3.0] Vein, Thrombosis 1 [2.0] Nose (50) (50) (50) (50) Inflammation, Suppurative 2 [1.0] 1 [1.0] Polyp, Inflammatory 1 [3.0] Respiratory Epithelium, Mineralization 1 [1.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (50) (50) (50) Degeneration 1 [4.0] Cornea, Inflammation, Acute 1 [2.0] Retrobulbar, Inflammation, Suppurative 1 [3.0] Harderian Gland (50) (50) (49) (50) Hyperplasia 3 [1.3] 5 [1.6] 6 [1.8] 7 [1.4] ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Hydronephrosis 1 [2.0] Infarct 2 [1.5] 3 [1.0] 2 [1.0] 4 [1.5] Inflammation, Acute 2 [2.5] Metaplasia, Osseous 1 [1.0] 4 [1.0] 2 [1.0] 2 [1.0] Nephropathy 39 [1.3] 42 [1.2] 37 [1.0] 40 [1.2] Artery, Thrombosis 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 12 NTP Experiment-Test: 05109-14 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: CHRONIC WITH AVERAGE SEVERITY GRADES[b] Date: 06/06/02 Route: SKIN APPLICATION TRIETHANOLAMINE Time: 08:45:51 ____________________________________________________________________________________________________________________________________ MICE:B6C3F1 MALE 0 MG/KG 200 630 2000 MG/KG MG/KG MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Capsule, Inflammation, Chronic 1 [2.0] Glomerulus, Cyst 2 [2.5] 2 [2.0] Papilla, Necrosis 1 [3.0] Renal Tubule, Cyst 4 [2.3] 2 [1.5] 4 [1.3] Renal Tubule, Hyperplasia 1 [1.0] 1 [1.0] 2 [1.5] Urinary Bladder (50) (50) (50) (50) Cyst 1 [4.0] Inflammation, Acute 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------