TDMS Study 05069-08 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE NTP Experiment-Test: 05069-08 Report: PEIRPT03 Study Type: CHRONIC Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 CORE STUDY Facility: TSI Mason Research Chemical CAS #: 147-47-7 Lock Date: 08/21/92 Cage Range: All Reasons For Removal: 25019 Moribund Sacrifice 25020 Natural Death 25026 Other 25021 Terminal Sacrifice 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: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Early Deaths Moribund Sacrifice 19 10 9 9 Natural Death 12 19 19 19 Survivors Terminal Sacrifice 19 21 22 22 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (49) (47) (48) (47) Erosion 1 (2%) Intestine Large, Rectum (49) (47) (47) (46) Erosion 1 (2%) Intestine Large, Cecum (48) (43) (42) (45) Edema 1 (2%) Hemorrhage 1 (2%) Inflammation, Acute 1 (2%) 1 (2%) Ulcer 1 (2%) Intestine Small, Jejunum (49) (41) (44) (44) Inflammation, Chronic 1 (2%) Ulcer 1 (2%) Intestine Small, Ileum (45) (40) (42) (40) Inflammation, Chronic 1 (3%) Metaplasia, Osseous 1 (3%) Ulcer 1 (3%) Liver (50) (50) (50) (50) Angiectasis 3 (6%) 1 (2%) 2 (4%) 2 (4%) Basophilic Focus 35 (70%) 36 (72%) 32 (64%) 30 (60%) Clear Cell Focus 7 (14%) 7 (14%) 9 (18%) 12 (24%) Congestion 1 (2%) Eosinophilic Focus 12 (24%) 16 (32%) 17 (34%) 14 (28%) Hematopoietic Cell Proliferation 3 (6%) 1 (2%) Hepatodiaphragmatic Nodule 11 (22%) 5 (10%) 6 (12%) 16 (32%) Inflammation, Chronic 3 (6%) Inflammation, Granulomatous 1 (2%) Mixed Cell Focus 10 (20%) 6 (12%) 9 (18%) 11 (22%) Regeneration 1 (2%) 2 (4%) Centrilobular, Atrophy 1 (2%) Centrilobular, Necrosis 1 (2%) Centrilobular, Vacuolization Cytoplasmic 11 (22%) 5 (10%) 6 (12%) 9 (18%) Midzonal, Vacuolization Cytoplasmic 1 (2%) Periportal, Vacuolization Cytoplasmic 1 (2%) 1 (2%) Serosa, Inflammation, Acute 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Serosa, Necrosis 1 (2%) Mesentery (8) (8) (4) (3) Inflammation, Chronic 1 (13%) 1 (25%) Metaplasia, Osseous 1 (25%) Fat, Necrosis 6 (75%) 7 (88%) 2 (50%) 2 (67%) Pancreas (50) (50) (50) (50) Inflammation, Chronic 1 (2%) 1 (2%) Metaplasia, Hepatocyte 1 (2%) Acinus, Atrophy 19 (38%) 15 (30%) 14 (28%) 14 (28%) Acinus, Hyperplasia 1 (2%) Artery, Thrombosis 1 (2%) Duct, Cyst 1 (2%) 1 (2%) Salivary Glands (50) (50) (50) (50) Atrophy 1 (2%) 1 (2%) 1 (2%) Duct, Cyst 1 (2%) Stomach, Forestomach (50) (50) (49) (50) Diverticulum 1 (2%) Hyperplasia, Squamous 13 (26%) 10 (20%) 6 (12%) 7 (14%) Inflammation, Chronic 9 (18%) 6 (12%) 5 (10%) 5 (10%) Perforation 1 (2%) Ulcer 10 (20%) 8 (16%) 5 (10%) 5 (10%) Stomach, Glandular (50) (50) (50) (49) Erosion 13 (26%) 6 (12%) 6 (12%) 7 (14%) Hyperplasia 1 (2%) Mineralization 1 (2%) Ulcer 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Cardiomyopathy 41 (82%) 46 (92%) 43 (86%) 43 (86%) Mineralization 1 (2%) Atrium, Thrombosis 3 (6%) 2 (4%) 2 (4%) Valve, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Angiectasis 1 (2%) 1 (2%) Atrophy 1 (2%) Degeneration 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) Hyperplasia 7 (14%) 4 (8%) 2 (4%) 5 (10%) Necrosis 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Vacuolization Cytoplasmic 13 (26%) 12 (24%) 8 (16%) 8 (16%) Adrenal Medulla (50) (50) (50) (50) Hyperplasia 8 (16%) 3 (6%) 3 (6%) 3 (6%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia 1 (2%) 1 (2%) Metaplasia, Hepatocyte 1 (2%) 1 (2%) Parathyroid Gland (44) (50) (49) (48) Hyperplasia 1 (2%) 1 (2%) Pituitary Gland (49) (50) (50) (50) Craniopharyngeal Duct, Pars Intermedia, Hyperplasia 1 (2%) Pars Distalis, Angiectasis 9 (18%) 13 (26%) 7 (14%) 11 (22%) Pars Distalis, Cyst 6 (12%) 2 (4%) 1 (2%) Pars Distalis, Hyperplasia 11 (22%) 13 (26%) 16 (32%) 11 (22%) Rathke's Cleft, Cyst 1 (2%) Rathke's Cleft, Hemorrhage 1 (2%) Thyroid Gland (49) (50) (48) (49) Hyperplasia 1 (2%) C-Cell, Hyperplasia 9 (18%) 12 (24%) 11 (23%) 4 (8%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (46) (45) (49) Cyst 3 (6%) 2 (4%) 1 (2%) 2 (4%) Hyperplasia 3 (6%) 1 (2%) Inflammation, Acute 1 (2%) 2 (4%) 2 (4%) 1 (2%) Inflammation, Chronic 2 (4%) Metaplasia, Squamous 1 (2%) Ovary (50) (50) (50) (50) Cyst 8 (16%) 2 (4%) 5 (10%) 7 (14%) Bilateral, Cyst 1 (2%) 2 (4%) Uterus (50) (50) (50) (50) Cyst 1 (2%) 1 (2%) Hyperplasia, Cystic 1 (2%) Inflammation, Chronic 1 (2%) Vagina (1) (2) Inflammation, Chronic 1 (50%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (49) (50) (50) Hyperplasia, Reticulum Cell 1 (2%) Myelofibrosis 1 (2%) 1 (2%) Lymph Node (13) (10) (7) (1) Bronchial, Depletion Lymphoid 1 (10%) Lumbar, Depletion Lymphoid 1 (10%) Mediastinal, Congestion 1 (8%) Mediastinal, Ectasia 1 (10%) Mediastinal, Hemorrhage 3 (30%) Mediastinal, Infiltration Cellular, Plasma Cell 1 (10%) 1 (14%) Pancreatic, Ectasia 1 (10%) Pancreatic, Erythrophagocytosis 1 (8%) Pancreatic, Pigmentation 1 (10%) Renal, Hemorrhage 1 (8%) 1 (14%) Lymph Node, Mandibular (50) (50) (50) (50) Hemorrhage 3 (6%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Plasma Cell 2 (4%) 1 (2%) 1 (2%) Lymph Node, Mesenteric (50) (49) (50) (50) Ectasia 1 (2%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Polymorphonuclear 1 (2%) Inflammation, Acute 1 (2%) Spleen (50) (50) (50) (50) Congestion 1 (2%) Fibrosis 6 (12%) 4 (8%) 3 (6%) Hematopoietic Cell Proliferation 3 (6%) 5 (10%) 6 (12%) 4 (8%) Pigmentation 1 (2%) 1 (2%) Capsule, Necrosis 1 (2%) Thymus (47) (50) (49) (50) Cyst 1 (2%) 1 (2%) Ectopic Parathyroid Gland 2 (4%) 1 (2%) Metaplasia, Osseous 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (49) (49) (50) Galactocele 2 (4%) 10 (20%) 3 (6%) 5 (10%) Inflammation, Chronic Active 1 (2%) Skin (50) (50) (50) (50) Acanthosis 2 (4%) 1 (2%) 5 (10%) 3 (6%) Inflammation, Acute 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Inflammation, Chronic 6 (12%) 10 (20%) 8 (16%) 8 (16%) Necrosis 1 (2%) Necrosis, Chronic 1 (2%) Ulcer 1 (2%) Skin, Site of Application, Acanthosis 1 (2%) 9 (18%) 22 (44%) Skin, Site of Application, Hyperkeratosis 1 (2%) 7 (14%) 1 (2%) Skin, Site of Application, Inflammation, Chronic 1 (2%) 2 (4%) 2 (4%) Subcutaneous Tissue, Foreign Body 1 (2%) Subcutaneous Tissue, Inflammation, Chronic 2 (4%) 3 (6%) 3 (6%) 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 1 (2%) Subcutaneous Tissue, Skin, Site of Application, Inflammation, Chronic 2 (4%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 2 (4%) Hyperostosis 1 (2%) Cranium, Fracture 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage 1 (2%) 1 (2%) 2 (4%) 1 (2%) Peripheral Nerve (1) Axon, Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 1 (2%) 1 (2%) Edema 1 (2%) Hemorrhage 1 (2%) Infiltration Cellular, Histiocyte 5 (10%) 5 (10%) 2 (4%) 3 (6%) Inflammation, Acute 1 (2%) Inflammation, Chronic 3 (6%) 1 (2%) 3 (6%) Inflammation, Chronic Active 1 (2%) Inflammation, Granulomatous 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 3 (6%) 2 (4%) Alveolus, Edema 1 (2%) Capillary, Thrombosis 1 (2%) Serosa, Fibrosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nose (50) (50) (50) (49) Foreign Body 2 (4%) 2 (4%) 2 (4%) 4 (8%) Fungus 2 (4%) 3 (6%) 2 (4%) 2 (4%) Inflammation, Chronic 1 (2%) Inflammation, Chronic Active 4 (8%) 6 (12%) 3 (6%) 7 (14%) Thrombosis 3 (6%) 3 (6%) 1 (2%) Nasolacrimal Duct, Inflammation, Acute 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (3) Iris, Synechia 1 (50%) Lens, Cataract 2 (100%) 3 (100%) Posterior Chamber, Hemorrhage 1 (33%) Retina, Atrophy 1 (50%) Retina, Degeneration 1 (50%) 2 (67%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Accumulation, Hyaline Droplet 4 (8%) Hydronephrosis 1 (2%) Infarct 1 (2%) Inflammation, Acute 1 (2%) Nephropathy, Chronic 49 (98%) 45 (90%) 48 (96%) 49 (98%) Pigmentation 2 (4%) 1 (2%) 1 (2%) Papilla, Necrosis 1 (2%) Renal Tubule, Hyperplasia 1 (2%) Urinary Bladder (50) (48) (49) (50) Hemorrhage 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Early Deaths Natural Death 21 26 25 23 Moribund Sacrifice 24 22 20 26 Survivors Terminal Sacrifice 5 2 4 1 Other 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (47) (47) (42) (44) Inflammation, Acute 1 (2%) Ulcer 1 (2%) Intestine Large, Rectum (47) (49) (49) (45) Angiectasis 1 (2%) Inflammation, Acute 2 (4%) Inflammation, Chronic Active 1 (2%) Necrosis 1 (2%) Intestine Large, Cecum (42) (44) (36) (39) Dilatation 1 (2%) Erosion 1 (2%) Inflammation, Acute 2 (5%) 7 (16%) 4 (10%) Necrosis 1 (2%) 1 (2%) 1 (3%) Ulcer 3 (7%) 2 (5%) Intestine Small, Duodenum (50) (50) (46) (48) Diverticulum 1 (2%) Erosion 2 (4%) 1 (2%) Inflammation, Chronic Active 2 (4%) Ulcer 1 (2%) Intestine Small, Jejunum (46) (45) (42) (39) Inflammation, Acute 1 (2%) Intestine Small, Ileum (40) (37) (34) (37) Diverticulum 1 (3%) Fibrosis 1 (3%) Inflammation, Chronic 1 (3%) 1 (3%) 1 (3%) Metaplasia, Osseous 1 (3%) Necrosis 1 (3%) Ulcer 1 (3%) Liver (50) (50) (50) (50) Angiectasis 6 (12%) 5 (10%) 1 (2%) 1 (2%) Basophilic Focus 8 (16%) 4 (8%) 3 (6%) 4 (8%) Clear Cell Focus 5 (10%) 3 (6%) 3 (6%) 3 (6%) Congestion 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Degeneration, Cystic 3 (6%) 6 (12%) 7 (14%) 2 (4%) Eosinophilic Focus 1 (2%) 1 (2%) Hepatodiaphragmatic Nodule 8 (16%) 7 (14%) 8 (16%) 4 (8%) Hyperplasia 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic 1 (2%) 3 (6%) Leukocytosis 1 (2%) Mineralization 1 (2%) Mixed Cell Focus 1 (2%) 4 (8%) Necrosis 4 (8%) 2 (4%) 3 (6%) Regeneration 1 (2%) 1 (2%) Centrilobular, Necrosis 3 (6%) 1 (2%) 2 (4%) 4 (8%) Centrilobular, Vacuolization Cytoplasmic 12 (24%) 6 (12%) 8 (16%) 7 (14%) Periportal, Vacuolization Cytoplasmic 4 (8%) 2 (4%) 4 (8%) Serosa, Fibrosis 1 (2%) Serosa, Necrosis 1 (2%) Mesentery (10) (3) (3) (4) Hemorrhage 2 (20%) 2 (50%) Inflammation, Chronic 1 (33%) Inflammation, Granulomatous 1 (10%) Artery, Angiectasis 1 (25%) Fat, Necrosis 6 (60%) 2 (67%) 1 (33%) 1 (25%) Pancreas (50) (50) (50) (50) Cytoplasmic Alteration 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Inflammation, Granulomatous 1 (2%) Mineralization 1 (2%) Acinus, Atrophy 25 (50%) 21 (42%) 20 (40%) 23 (46%) Acinus, Hyperplasia 2 (4%) 3 (6%) 4 (8%) 6 (12%) Artery, Angiectasis 2 (4%) 2 (4%) Artery, Inflammation, Chronic 1 (2%) 1 (2%) Artery, Mineralization 1 (2%) 1 (2%) Salivary Glands (49) (50) (50) (50) Fibrosis 1 (2%) Stomach, Forestomach (50) (50) (50) (49) Erosion 1 (2%) Foreign Body 1 (2%) Hyperplasia, Squamous 29 (58%) 34 (68%) 31 (62%) 28 (57%) Inflammation, Acute 2 (4%) Inflammation, Chronic 17 (34%) 14 (28%) 20 (40%) 14 (29%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) 1 (2%) 5 (10%) 2 (4%) Perforation 4 (8%) 5 (10%) 7 (14%) 4 (8%) Ulcer 20 (40%) 25 (50%) 16 (32%) 15 (31%) Stomach, Glandular (50) (50) (50) (49) Erosion 13 (26%) 22 (44%) 22 (44%) 17 (35%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) Inflammation, Chronic 3 (6%) 1 (2%) 1 (2%) Metaplasia, Squamous 1 (2%) Mineralization 15 (30%) 19 (38%) 20 (40%) 16 (33%) Ulcer 2 (4%) 2 (4%) 3 (6%) 3 (6%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) (1) Aorta, Mineralization 1 (100%) Heart (50) (50) (50) (50) Cardiomyopathy 47 (94%) 48 (96%) 48 (96%) 44 (88%) Inflammation, Acute 2 (4%) Mineralization 10 (20%) 15 (30%) 13 (26%) 9 (18%) Thrombosis 1 (2%) Atrium, Inflammation, Acute 2 (4%) Atrium, Thrombosis 4 (8%) 5 (10%) 9 (18%) 3 (6%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Angiectasis 2 (4%) Cytoplasmic Alteration 2 (4%) Hemorrhage 2 (4%) 2 (4%) 3 (6%) 1 (2%) Hyperplasia 2 (4%) 2 (4%) 2 (4%) 5 (10%) Hypertrophy 1 (2%) Inflammation, Acute 1 (2%) Necrosis 2 (4%) Vacuolization Cytoplasmic 9 (18%) 11 (22%) 11 (22%) 9 (18%) Adrenal Medulla (50) (50) (50) (50) Hyperplasia 28 (56%) 33 (66%) 30 (60%) 23 (46%) Mineralization 1 (2%) Islets, Pancreatic (50) (50) (49) (50) Hyperplasia 4 (8%) 1 (2%) 1 (2%) Parathyroid Gland (48) (49) (46) (49) Hyperplasia 18 (38%) 21 (43%) 23 (50%) 23 (47%) Mineralization 1 (2%) 1 (2%) Pituitary Gland (49) (50) (50) (49) Angiectasis 1 (2%) 1 (2%) Mineralization 1 (2%) Craniopharyngeal Duct, Hyperplasia 1 (2%) Craniopharyngeal Duct, Pars Nervosa, Hyperplasia 1 (2%) Pars Distalis, Angiectasis 4 (8%) 2 (4%) 4 (8%) 1 (2%) Pars Distalis, Cyst 3 (6%) 4 (8%) 6 (12%) 8 (16%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Distalis, Hemorrhage 1 (2%) Pars Distalis, Hyperplasia 11 (22%) 14 (28%) 12 (24%) 14 (29%) Pars Distalis, Pigmentation 1 (2%) 2 (4%) Pars Intermedia, Angiectasis 1 (2%) Pars Intermedia, Cyst 2 (4%) 1 (2%) Pars Nervosa, Cyst 1 (2%) 1 (2%) 1 (2%) Rathke's Cleft, Cyst 1 (2%) 2 (4%) Thyroid Gland (50) (50) (50) (50) Cyst 1 (2%) Mineralization 1 (2%) C-Cell, Hyperplasia 4 (8%) 7 (14%) 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Mediastinum, Necrosis 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Atrophy 1 (2%) Granuloma Sperm 2 (4%) Inflammation, Acute 1 (2%) Inflammation, Granulomatous 1 (2%) Mineralization 1 (2%) Necrosis 1 (2%) Penis (6) (10) (2) (2) Foreign Body 1 (17%) Inflammation, Acute 2 (33%) 5 (50%) 1 (50%) 1 (50%) Inflammation, Chronic Active 1 (17%) Mineralization 1 (10%) Preputial Gland (50) (49) (49) (49) Abscess 1 (2%) Cyst 1 (2%) 2 (4%) Fibrosis 1 (2%) Hyperplasia 1 (2%) 1 (2%) Inflammation, Acute 5 (10%) 2 (4%) 5 (10%) 8 (16%) Inflammation, Chronic 4 (8%) 1 (2%) Inflammation, Chronic Active 1 (2%) Inflammation, Granulomatous 1 (2%) Prostate (50) (50) (50) (49) Developmental Malformation 1 (2%) Inflammation, Acute 1 (2%) 1 (2%) Inflammation, Chronic 23 (46%) 28 (56%) 22 (44%) 24 (49%) Inflammation, Chronic Active 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Seminal Vesicle (50) (50) (50) (50) Inflammation, Acute 1 (2%) Inflammation, Chronic 2 (4%) Inflammation, Chronic Active 1 (2%) 1 (2%) Mineralization 2 (4%) 2 (4%) Testes (50) (50) (50) (50) Hemorrhage 1 (2%) Mineralization 2 (4%) 1 (2%) 1 (2%) 2 (4%) Arteriole, Inflammation, Chronic 1 (2%) Interstitial Cell, Hyperplasia 27 (54%) 22 (44%) 25 (50%) 31 (62%) Seminiferous Tubule, Degeneration 21 (42%) 25 (50%) 26 (52%) 23 (46%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Hypoplasia 4 (8%) 2 (4%) Myelofibrosis 5 (10%) Necrosis 1 (2%) 1 (2%) Lymph Node (19) (15) (6) (9) Mediastinal, Angiectasis 2 (11%) Mediastinal, Congestion 1 (5%) 1 (11%) Mediastinal, Ectasia 1 (5%) 2 (13%) Mediastinal, Erythrophagocytosis 2 (11%) 2 (13%) Mediastinal, Hemorrhage 1 (5%) 3 (20%) 1 (17%) 1 (11%) Mediastinal, Infiltration Cellular, Plasma Cell 1 (5%) Mediastinal, Infiltration Cellular, Histiocyte 1 (5%) Mediastinal, Pigmentation 1 (11%) Pancreatic, Angiectasis 1 (5%) 1 (7%) Pancreatic, Congestion 1 (5%) Pancreatic, Ectasia 1 (7%) Pancreatic, Hemorrhage 2 (11%) 2 (13%) Pancreatic, Hyperplasia, Lymphoid 1 (7%) Pancreatic, Infiltration Cellular, Plasma Cell 1 (11%) Pancreatic, Necrosis 1 (5%) Renal, Ectasia 1 (5%) Renal, Hemorrhage 1 (11%) Lymph Node, Mandibular (49) (50) (50) (50) Ectasia 1 (2%) Erythrophagocytosis 1 (2%) Hemorrhage 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 2 (4%) Infiltration Cellular, Plasma Cell 5 (10%) 2 (4%) Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Necrosis 1 (2%) Lymph Node, Mesenteric (50) (50) (50) (49) Angiectasis 2 (4%) 1 (2%) 2 (4%) Congestion 1 (2%) Depletion Lymphoid 1 (2%) 1 (2%) 1 (2%) Ectasia 5 (10%) 3 (6%) 6 (12%) 3 (6%) Erythrophagocytosis 2 (4%) 2 (4%) 2 (4%) Hemorrhage 3 (6%) 5 (10%) 2 (4%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Infiltration Cellular, Polymorphonuclear 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Acute 1 (2%) Spleen (50) (50) (50) (50) Fibrosis 11 (22%) 12 (24%) 12 (24%) 13 (26%) Hematopoietic Cell Proliferation 2 (4%) 7 (14%) 6 (12%) 2 (4%) Necrosis 2 (4%) Pigmentation 2 (4%) Capsule, Necrosis 2 (4%) 4 (8%) Lymphoid Follicle, Depletion Cellular 1 (2%) Red Pulp, Thrombosis 1 (2%) Thymus (45) (44) (49) (46) Angiectasis 1 (2%) Ectopic Parathyroid Gland 3 (6%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (42) (42) (45) (40) Galactocele 12 (29%) 5 (12%) 3 (7%) 2 (5%) Skin (50) (50) (49) (50) Acanthosis 9 (18%) 5 (10%) 6 (12%) 7 (14%) Hyperkeratosis 1 (2%) 1 (2%) 5 (10%) Inflammation, Acute 2 (4%) 2 (4%) 1 (2%) 1 (2%) Inflammation, Chronic 2 (4%) 1 (2%) 1 (2%) Ulcer 1 (2%) 1 (2%) 1 (2%) Skin, Site of Application, Acanthosis 1 (2%) 4 (8%) 14 (29%) 21 (42%) Skin, Site of Application, Cyst Epithelial Inclusion 1 (2%) Skin, Site of Application, Hyperkeratosis 2 (4%) 2 (4%) 2 (4%) 3 (6%) Skin, Site of Application, Inflammation, Chronic 3 (6%) Subcutaneous Tissue, Hemorrhage 1 (2%) Subcutaneous Tissue, Inflammation, Acute 1 (2%) Subcutaneous Tissue, Inflammation, Chronic 1 (2%) 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active 1 (2%) 1 (2%) Subcutaneous Tissue, Skin, Site of a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Application, Fibrosis 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 21 (42%) 24 (48%) 27 (54%) 25 (50%) Inflammation, Chronic 1 (2%) Osteomalacia 1 (2%) Mandible, Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage 4 (8%) 2 (4%) 3 (6%) 1 (2%) Inflammation, Acute 1 (2%) Cerebrum, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 1 (2%) 1 (2%) Emphysema 2 (4%) Hemorrhage 7 (14%) 9 (18%) 5 (10%) 4 (8%) Infiltration Cellular, Histiocyte 10 (20%) 13 (26%) 15 (30%) 15 (30%) Inflammation, Acute 2 (4%) 1 (2%) 1 (2%) Inflammation, Chronic 3 (6%) 3 (6%) Inflammation, Chronic Active 1 (2%) Mineralization 2 (4%) 7 (14%) 6 (12%) 6 (12%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 3 (6%) 1 (2%) 1 (2%) Alveolus, Edema 4 (8%) 3 (6%) 9 (18%) 5 (10%) Capillary, Thrombosis 4 (8%) Nose (50) (49) (50) (50) Foreign Body 15 (30%) 11 (22%) 9 (18%) 9 (18%) Fungus 19 (38%) 21 (43%) 13 (26%) 10 (20%) Hemorrhage 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Chronic Active 26 (52%) 24 (49%) 22 (44%) 16 (32%) Thrombosis 2 (4%) 1 (2%) Ulcer 2 (4%) 4 (8%) 2 (4%) Vein, Thrombosis 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05069-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE Date: 03/13/95 Route: DERMAL,SOLUTION Time: 18:33:18 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 36 MG/KG 60 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (3) (3) Anterior Chamber, Inflammation, Acute 1 (33%) Choroid, Mineralization 1 (33%) Cornea, Inflammation, Acute 1 (33%) Iris, Synechia 1 (33%) Lens, Cataract 1 (100%) 3 (100%) 3 (100%) Retina, Degeneration 2 (67%) 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 13 (26%) 10 (20%) 17 (34%) 20 (40%) Hydronephrosis 1 (2%) Infarct 1 (2%) 1 (2%) Inflammation, Acute 2 (4%) Mineralization 3 (6%) 2 (4%) 5 (10%) 4 (8%) Nephropathy, Chronic 50 (100%) 50 (100%) 49 (98%) 50 (100%) Pigmentation 2 (4%) 1 (2%) Cortex, Mineralization 1 (2%) Renal Tubule, Degeneration, Hyaline 1 (2%) Renal Tubule, Hyperplasia 2 (4%) 6 (12%) 3 (6%) Vein, Thrombosis 1 (2%) Urinary Bladder (49) (50) (50) (48) Calculus Gross Observation 2 (4%) 1 (2%) Calculus Micro Observation Only 1 (2%) Hemorrhage 1 (2%) 1 (2%) 1 (2%) Inflammation, Acute 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------