TDMS Study 05109-11 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) TRIETHANOLAMINE NTP Experiment-Test: 05109-11 Report: PEIRPT03 Study Type: CHRONIC Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 Facility: Battelle Columbus Laboratory Chemical CAS #: 102-71-6 Lock Date: 07/29/92 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: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 14 17 13 15 Moribund Sacrifice 11 4 12 17 Survivors Natural Death 1 Terminal Sacrifice 25 29 25 17 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (60) (60) (60) (60) Perforation 2 (3%) Intestine Large, Colon (60) (60) (60) (60) Parasite Metazoan 2 (3%) 4 (7%) 3 (5%) 2 (3%) Intestine Large, Rectum (60) (60) (60) (60) Parasite Metazoan 3 (5%) 8 (13%) 6 (10%) 8 (13%) Intestine Large, Cecum (60) (60) (60) (60) Inflammation, Suppurative 1 (2%) Parasite Metazoan 1 (2%) Intestine Small, Jejunum (60) (60) (60) (60) Necrosis, Coagulative 1 (2%) Liver (60) (60) (60) (60) Angiectasis 1 (2%) 3 (5%) 3 (5%) Basophilic Focus 21 (35%) 28 (47%) 31 (52%) 11 (18%) Clear Cell Focus 1 (2%) 2 (3%) Eosinophilic Focus 2 (3%) 1 (2%) 5 (8%) 5 (8%) Hepatodiaphragmatic Nodule 11 (18%) 11 (18%) 12 (20%) 4 (7%) Inflammation, Chronic 21 (35%) 22 (37%) 29 (48%) 23 (38%) Inflammation, Necrotizing 1 (2%) 1 (2%) Mixed Cell Focus 2 (3%) 1 (2%) 1 (2%) Necrosis, Coagulative 2 (3%) 1 (2%) 2 (3%) Bile Duct, Hyperplasia 16 (27%) 15 (25%) 18 (30%) 13 (22%) Hepatocyte, Vacuolization Cytoplasmic 3 (5%) 2 (3%) 5 (8%) 4 (7%) Kupffer Cell, Hypertrophy 1 (2%) Mesentery (3) (2) (2) (2) Fat, Inflammation, Necrotizing 2 (67%) 2 (100%) Perivascular, Inflammation, Chronic Active 1 (50%) 1 (50%) Pancreas (60) (60) (60) (60) Acinus, Atrophy 5 (8%) 9 (15%) 17 (28%) 6 (10%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) Duct, Ectasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Perivascular, Inflammation, Chronic Active 1 (2%) Salivary Glands (60) (60) (60) (60) Duct, Ectasia 1 (2%) Stomach, Forestomach (60) (60) (60) (60) Inflammation, Necrotizing 2 (3%) 4 (7%) 2 (3%) 3 (5%) Epithelium, Hyperplasia 3 (5%) 2 (3%) 1 (2%) 3 (5%) Stomach, Glandular (60) (60) (60) (60) Erosion 1 (2%) 3 (5%) 1 (2%) 1 (2%) Inflammation, Necrotizing 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (60) (60) (59) (60) Aorta, Polyarteritis, Chronic 1 (2%) Mesenteric Artery, Polyarteritis, Chronic 1 (2%) Heart (60) (60) (60) (60) Cardiomyopathy, Chronic 41 (68%) 33 (55%) 41 (68%) 36 (60%) Inflammation, Chronic Active 1 (2%) Atrium, Thrombosis 2 (3%) 3 (5%) 4 (7%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Degeneration, Fatty 15 (25%) 16 (27%) 19 (32%) 11 (18%) Hyperplasia 15 (25%) 21 (35%) 17 (28%) 6 (10%) Hypertrophy 2 (3%) 2 (3%) 1 (2%) Karyomegaly 1 (2%) Necrosis, Coagulative 1 (2%) 1 (2%) Adrenal Medulla (60) (60) (60) (59) Hyperplasia 9 (15%) 8 (13%) 4 (7%) 4 (7%) Islets, Pancreatic (60) (60) (60) (60) Hyperplasia 1 (2%) Parathyroid Gland (51) (57) (57) (51) Cyst 1 (2%) Hyperplasia 1 (2%) Pituitary Gland (60) (60) (60) (60) Craniopharyngeal Duct, Pars Distalis, Cyst 1 (2%) 1 (2%) Pars Distalis, Angiectasis 37 (62%) 35 (58%) 36 (60%) 29 (48%) Pars Distalis, Cyst 30 (50%) 22 (37%) 33 (55%) 20 (33%) Pars Distalis, Hyperplasia 18 (30%) 24 (40%) 20 (33%) 15 (25%) Pars Distalis, Pigmentation, Hemosiderin 33 (55%) 29 (48%) 27 (45%) 22 (37%) Pars Intermedia, Cyst 1 (2%) 1 (2%) Thyroid Gland (60) (60) (60) (59) C-Cell, Hyperplasia 8 (13%) 5 (8%) 10 (17%) 3 (5%) Follicle, Cyst 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (58) (59) (60) (60) Hyperplasia 3 (5%) 8 (14%) 4 (7%) 1 (2%) Inflammation, Chronic Active 11 (19%) 19 (32%) 20 (33%) 10 (17%) Duct, Dilatation 2 (3%) 1 (2%) 4 (7%) 3 (5%) Ovary (60) (60) (60) (60) Atrophy 1 (2%) Cyst 3 (5%) 4 (7%) 4 (7%) 2 (3%) Hematocyst 1 (2%) Uterus (60) (60) (60) (60) Hyperplasia, Cystic, Glandular 1 (2%) Horn, Dilatation 3 (5%) Lumen, Hemorrhage 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Hyperplasia 2 (3%) 3 (5%) 2 (3%) 5 (8%) Myelofibrosis 1 (2%) Lymph Node (6) (5) (6) (3) Mediastinal, Pigmentation, Hemosiderin 1 (17%) Mediastinal, Sinus, Infiltration Cellular, Mononuclear Cell 1 (17%) Lymph Node, Mandibular (59) (60) (60) (60) Inflammation, Necrotizing 1 (2%) Inflammation, Suppurative 1 (2%) Sinus, Ectasia 1 (2%) Lymph Node, Mesenteric (60) (60) (59) (60) Inflammation, Chronic Active 1 (2%) Spleen (60) (60) (60) (60) Fibrosis 2 (3%) 2 (3%) Hematopoietic Cell Proliferation 2 (3%) 1 (2%) 1 (2%) Infiltration Cellular, Lipocyte 1 (2%) Red Pulp, Atrophy 1 (2%) 1 (2%) Thymus (59) (57) (57) (58) Fibrosis 1 (2%) Granuloma 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (60) (60) (60) Hyperplasia, Cystic 47 (78%) 44 (73%) 50 (83%) 44 (73%) Inflammation, Chronic Active 1 (2%) Skin (60) (60) (60) (60) Epidermis, Site of Application-No Mass, Erosion 1 (2%) 6 (10%) 16 (27%) 14 (23%) Face, Abscess 1 (2%) Head, Acanthosis 2 (3%) Head, Inflammation, Chronic Active 1 (2%) 2 (3%) Head, Ulcer 1 (2%) Inguinal, Acanthosis 1 (2%) 1 (2%) Inguinal, Inflammation, Chronic Active 2 (3%) 1 (2%) 2 (3%) 1 (2%) Site of Application-No Mass, Acanthosis 2 (3%) 11 (18%) 37 (62%) 38 (63%) Site of Application-No Mass, Inflammation, Chronic Active 2 (3%) 11 (18%) 37 (62%) 38 (63%) Site of Application-No Mass, Ulcer 7 (12%) 9 (15%) Site of Application-No Mass, Ulcer, Multiple 2 (3%) 8 (13%) 22 (37%) 24 (40%) Tail, Acanthosis 1 (2%) Tail, Hyperkeratosis 1 (2%) Tail, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Osteopetrosis 3 (5%) 1 (2%) Maxilla, Abscess 1 (2%) Skeletal Muscle (1) (2) Fibrosis 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Compression 18 (30%) 15 (25%) 15 (25%) 12 (20%) Hemorrhage 3 (5%) 1 (2%) Hydrocephalus 10 (17%) 9 (15%) 10 (17%) 13 (22%) Necrosis 1 (2%) Peripheral Nerve (2) (1) Sciatic, Myelin, Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Inflammation, Chronic Active 16 (27%) 18 (30%) 17 (28%) 22 (37%) Inflammation, Necrotizing 1 (2%) Metaplasia, Osseous 1 (2%) Pigmentation, Hemosiderin 1 (2%) Alveolar Epithelium, Hyperplasia 4 (7%) 1 (2%) 1 (2%) Alveolus, Infiltration Cellular, Mononuclear Cell 34 (57%) 43 (72%) 37 (62%) 34 (57%) Artery, Mediastinum, Polyarteritis, Chronic 1 (2%) Perivascular, Edema 1 (2%) Nose (60) (60) (60) (60) Inflammation, Chronic Active 9 (15%) 5 (8%) 8 (13%) 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 11 (18%) 9 (15%) 9 (15%) 8 (13%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (4) (6) (1) Lens, Cataract 2 (100%) 3 (75%) 5 (83%) 1 (100%) Retina, Atrophy 2 (100%) 3 (75%) 6 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Nephropathy, Chronic 54 (90%) 52 (87%) 49 (82%) 46 (77%) Cortex, Cyst 2 (3%) Renal Tubule, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 59 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 9 12 6 8 Moribund Sacrifice 18 27 25 23 Accidently Killed 2 Survivors Terminal Sacrifice 21 11 18 19 Animals Examined Microscopically 60 60 59 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (60) (60) (59) (60) Inflammation, Necrotizing 1 (2%) Parasite Metazoan 4 (7%) 5 (8%) 2 (3%) 3 (5%) Intestine Large, Rectum (60) (60) (59) (60) Parasite Metazoan 6 (10%) 6 (10%) 11 (19%) 8 (13%) Intestine Large, Cecum (60) (60) (59) (60) Inflammation, Necrotizing 1 (2%) Inflammation, Suppurative 2 (3%) Parasite Metazoan 1 (2%) Intestine Small, Duodenum (60) (60) (59) (60) Inflammation, Necrotizing 2 (3%) Intestine Small, Ileum (60) (60) (59) (60) Parasite Metazoan 1 (2%) Liver (60) (60) (59) (60) Angiectasis 1 (2%) 2 (3%) Basophilic Focus 7 (12%) 7 (12%) 4 (7%) 10 (17%) Clear Cell Focus 5 (8%) 4 (7%) 4 (7%) 1 (2%) Congestion 1 (2%) Eosinophilic Focus 2 (3%) 4 (7%) 3 (5%) 2 (3%) Hepatodiaphragmatic Nodule 4 (7%) 5 (8%) 7 (12%) 3 (5%) Hyperplasia, Nodular 1 (2%) Inflammation, Chronic 12 (20%) 24 (40%) 19 (32%) 15 (25%) Leukocytosis 1 (2%) Mixed Cell Focus 1 (2%) 3 (5%) 2 (3%) Necrosis, Coagulative 1 (2%) 2 (3%) 2 (3%) 2 (3%) Bile Duct, Hyperplasia 56 (93%) 49 (82%) 53 (90%) 52 (87%) Hepatocyte, Degeneration, Cystic 8 (13%) 6 (10%) 6 (10%) 8 (13%) Hepatocyte, Vacuolization Cytoplasmic 6 (10%) 7 (12%) 5 (8%) 6 (10%) Mesentery (9) (10) (11) (5) Fat, Inflammation, Necrotizing 6 (67%) 7 (70%) 6 (55%) 4 (80%) Pancreas (60) (60) (59) (60) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Subacute 1 (2%) Acinus, Atrophy 23 (38%) 21 (35%) 19 (32%) 17 (28%) Acinus, Hyperplasia, Nodular 1 (2%) 3 (5%) Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (3%) Artery, Thrombosis 1 (2%) Perivascular, Inflammation, Chronic Active 1 (2%) Stomach, Forestomach (60) (60) (59) (60) Foreign Body, Multiple 1 (2%) Granuloma 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Inflammation, Necrotizing 4 (7%) 3 (5%) 8 (14%) 6 (10%) Mineralization 1 (2%) Epithelium, Hyperplasia 6 (10%) 6 (10%) 9 (15%) 5 (8%) Stomach, Glandular (60) (60) (59) (60) Cyst Epithelial Inclusion 1 (2%) Erosion 5 (8%) 3 (5%) 1 (2%) Hyperplasia, Glandular 1 (2%) Inflammation, Necrotizing 2 (3%) 2 (3%) 3 (5%) Mineralization 1 (2%) Necrosis, Coagulative 1 (2%) 1 (2%) Tongue (1) Cyst 1 (100%) Tooth (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (60) (60) (59) (59) Mineralization 1 (2%) 1 (2%) Mesenteric Artery, Polyarteritis, Chronic 1 (2%) Mesenteric Artery, Thrombosis 1 (2%) Heart (60) (60) (59) (60) Cardiomyopathy, Chronic 51 (85%) 52 (87%) 52 (88%) 55 (92%) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) Atrium, Thrombosis 2 (3%) 1 (2%) 1 (2%) 1 (2%) Endocardium, Atrium, Proliferation 1 (2%) Valve, Bacterium 1 (2%) Valve, Inflammation, Chronic Active 2 (3%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (59) (60) Accessory Adrenal Cortical Nodule 1 (2%) Degeneration, Fatty 21 (35%) 17 (28%) 20 (34%) 22 (37%) Hyperplasia 15 (25%) 17 (28%) 19 (32%) 24 (40%) Hypertrophy 7 (12%) 5 (8%) 6 (10%) 5 (8%) Karyomegaly 1 (2%) Necrosis, Coagulative 1 (2%) Adrenal Medulla (60) (60) (59) (60) Hyperplasia 28 (47%) 22 (37%) 22 (37%) 21 (35%) Islets, Pancreatic (60) (60) (59) (60) Hyperplasia 2 (3%) 3 (5%) 1 (2%) Parathyroid Gland (55) (57) (53) (56) Cyst 1 (2%) 1 (2%) 1 (2%) Hyperplasia 3 (5%) 3 (5%) 3 (6%) 1 (2%) Pituitary Gland (60) (60) (58) (60) Craniopharyngeal Duct, Pars Distalis, Cyst 1 (2%) Pars Distalis, Angiectasis 30 (50%) 36 (60%) 29 (50%) 39 (65%) Pars Distalis, Cyst 4 (7%) 2 (3%) 3 (5%) 4 (7%) Pars Distalis, Hyperplasia 9 (15%) 16 (27%) 15 (26%) 18 (30%) Pars Distalis, Infarct 1 (2%) 1 (2%) 1 (2%) Pars Distalis, Pigmentation, Hemosiderin 23 (38%) 24 (40%) 32 (55%) 35 (58%) Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (60) (60) (59) (60) Cyst 1 (2%) Hyperplasia 1 (2%) C-Cell, Hyperplasia 8 (13%) 7 (12%) 8 (14%) 9 (15%) Follicle, Cyst 1 (2%) 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Ectasia 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (59) (60) Atrophy 26 (43%) 25 (42%) 27 (46%) 20 (33%) Fibrosis 1 (2%) Granuloma Sperm 1 (2%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) 1 (2%) Fat, Necrosis 1 (2%) Preputial Gland (60) (60) (58) (60) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Hyperplasia 3 (5%) Inflammation, Chronic Active 54 (90%) 53 (88%) 51 (88%) 58 (97%) Duct, Dilatation 5 (8%) 4 (7%) 5 (9%) 2 (3%) Prostate (60) (59) (59) (60) Hyperplasia, Cystic 1 (2%) Inflammation, Chronic Active 52 (87%) 52 (88%) 50 (85%) 56 (93%) Inflammation, Hemorrhagic 1 (2%) 1 (2%) Epithelium, Hyperplasia 1 (2%) Seminal Vesicle (60) (60) (59) (60) Atrophy 24 (40%) 22 (37%) 23 (39%) 13 (22%) Mineralization 1 (2%) Testes (60) (60) (59) (60) Polyarteritis 9 (15%) 4 (7%) 9 (15%) 6 (10%) Interstitial Cell, Hyperplasia 21 (35%) 22 (37%) 19 (32%) 25 (42%) Seminiferous Tubule, Atrophy 10 (17%) 8 (13%) 14 (24%) 9 (15%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (59) (60) Hyperplasia 1 (2%) 3 (5%) 5 (8%) 4 (7%) Myelofibrosis 1 (2%) 1 (2%) Lymph Node (15) (10) (16) (9) Inguinal, Sinus, Ectasia 1 (10%) Mediastinal, Sinus, Hemorrhage 1 (6%) Lymph Node, Mandibular (60) (60) (59) (60) Hyperplasia, Lymphoid 1 (2%) Necrosis, Coagulative 1 (2%) Lymph Node, Mesenteric (60) (60) (59) (59) Sinus, Ectasia 1 (2%) 1 (2%) Spleen (60) (60) (59) (60) Congestion 1 (2%) 1 (2%) Developmental Malformation 1 (2%) Fibrosis 10 (17%) 3 (5%) 5 (8%) 7 (12%) Hematopoietic Cell Proliferation 1 (2%) 2 (3%) 1 (2%) Necrosis, Coagulative 3 (5%) 1 (2%) 2 (3%) 2 (3%) Thrombosis 1 (2%) Red Pulp, Atrophy 1 (2%) Thymus (56) (59) (58) (59) Cyst 1 (2%) Developmental Malformation 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (58) (53) (54) (54) Cyst 1 (2%) Hyperplasia, Cystic 46 (79%) 37 (70%) 37 (69%) 42 (78%) Inflammation, Chronic 1 (2%) Inflammation, Chronic Active 2 (3%) 2 (4%) 1 (2%) Inflammation, Proliferative 1 (2%) 1 (2%) Skin (60) (60) (59) (60) Dermis, Site of Application-No Mass, Fibrosis 1 (2%) 1 (2%) 1 (2%) Dermis, Site of Application-Mass, Fibrosis 1 (2%) Epidermis, Site of Application-No Mass, Erosion 1 (2%) Foot, Acanthosis 1 (2%) Foot, Hyperkeratosis 1 (2%) Foot, Inflammation, Chronic Active 1 (2%) Foot, Ulcer 1 (2%) Inguinal, Acanthosis 2 (3%) 1 (2%) 1 (2%) Inguinal, Inflammation, Chronic Active 2 (3%) 1 (2%) Inguinal, Ulcer 1 (2%) Neck, Ventral, Inflammation, Chronic Active 1 (2%) Prepuce, Inflammation, Suppurative 1 (2%) Site of Application-No Mass, Acanthosis 1 (2%) 1 (2%) 1 (2%) 11 (18%) Site of Application-No Mass, Inflammation, Chronic Active 2 (3%) 8 (13%) Site of Application-No Mass, Ulcer 4 (7%) Site of Application-No Mass, Ulcer, Multiple 1 (2%) Tail, Acanthosis 1 (2%) Tail, Hyperkeratosis 1 (2%) Tail, Inflammation, Chronic Active 1 (2%) 1 (2%) Tail, Ulcer 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (59) (60) Fibrous Osteodystrophy 1 (2%) 1 (2%) Femur, Cyst 1 (2%) Maxilla, Abscess 1 (2%) 1 (2%) 1 (2%) Maxilla, Fibrosis 2 (3%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (58) (60) Compression 15 (25%) 19 (32%) 10 (17%) 21 (35%) Gliosis 1 (2%) Hemorrhage 1 (2%) 4 (7%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Hydrocephalus 14 (23%) 19 (32%) 9 (16%) 18 (30%) Peripheral Nerve (2) (2) Sciatic, Myelin, Degeneration 1 (50%) Spinal Cord (2) (2) Hemorrhage 1 (50%) White Matter, Degeneration 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (59) (60) Inflammation, Chronic Active 8 (13%) 5 (8%) 6 (10%) 5 (8%) Inflammation, Suppurative 1 (2%) Metaplasia, Osseous 1 (2%) Mineralization 1 (2%) Alveolar Epithelium, Hyperplasia 2 (3%) 3 (5%) 1 (2%) Alveolus, Infiltration Cellular, Mononuclear Cell 17 (28%) 23 (38%) 20 (34%) 13 (22%) Fat, Mediastinum, Atrophy 1 (2%) Mediastinum, Fibrosis 1 (2%) Perivascular, Edema 1 (2%) Nose (60) (60) (59) (60) Fungus 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Chronic Active 5 (8%) 4 (7%) 3 (5%) 9 (15%) Nasolacrimal Duct, Inflammation, Suppurative 12 (20%) 11 (18%) 8 (14%) 8 (13%) Respiratory Epithelium, Hyperplasia 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) (2) (1) Cyst Epithelial Inclusion 1 (50%) Eye (3) (3) (2) Lens, Cataract 1 (33%) 3 (100%) 2 (100%) Retina, Atrophy 1 (33%) 3 (100%) 2 (100%) Zymbal's Gland (2) (2) (1) Abscess 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (59) (60) Hydronephrosis 1 (2%) 1 (2%) Hyperplasia 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Necrosis, Coagulative 1 (2%) 1 (2%) Nephropathy, Chronic 58 (97%) 58 (97%) 59 (100%) 60 (100%) Pigmentation, Hemosiderin 1 (2%) Cortex, Cyst 2 (3%) 1 (2%) Renal Tubule, Hyperplasia 1 (2%) Urinary Bladder (60) (60) (58) (59) Dilatation 1 (2%) Inflammation, Hemorrhagic 2 (3%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 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