TDMS Study 05057-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) HC YELLOW 4 NTP Experiment-Test: 05057-01 Report: PEIRPT03 Study Type: CHRONIC Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 Facility: TSI Mason Research Chemical CAS #: 5982043-8 Lock Date: None 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: 05057-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 70 70 Scheduled Sacrifice 20 20 20 Early Deaths Moribund 21 15 15 Dead 2 4 1 Survivors Terminal Sacrifice 26 30 34 Moribund 1 1 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (48) (49) (49) Parasite 1 (2%) Intestine Large, Colon (48) (47) (47) Parasite 1 (2%) 1 (2%) Intestine Large, Rectum (48) (46) (49) Parasite 2 (4%) 1 (2%) Liver (50) (50) (50) Basophilic Focus 37 (74%) 32 (64%) 41 (82%) Clear Cell Focus 1 (2%) 3 (6%) 2 (4%) Eosinophilic Focus 1 (2%) 2 (4%) Fatty Change, Diffuse 7 (14%) 7 (14%) 4 (8%) Fatty Change, Focal 7 (14%) 2 (4%) 3 (6%) Hepatodiaphragmatic Nodule 4 (8%) 3 (6%) 9 (18%) Hyperplasia 1 (2%) Inflammation, Granulomatous 30 (60%) 22 (44%) 27 (54%) Mixed Cell Focus 6 (12%) 5 (10%) 7 (14%) Necrosis 3 (6%) Thrombosis 1 (2%) 1 (2%) Bile Duct, Hyperplasia 26 (52%) 24 (48%) 32 (64%) Pancreas (49) (50) (49) Acinus, Atrophy 1 (2%) Duct, Hyperplasia 1 (2%) Stomach, Forestomach (50) (48) (50) Acanthosis 1 (2%) 7 (15%) 4 (8%) Hyperkeratosis 2 (4%) 4 (8%) 2 (4%) Mineralization 1 (2%) Necrosis 1 (2%) Ulcer 2 (4%) 1 (2%) Stomach, Glandular (50) (50) (50) Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) Cardiomyopathy 23 (46%) 28 (56%) 23 (46%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (49) (50) Hyperplasia 1 (2%) 2 (4%) 2 (4%) Adrenal Gland, Medulla (49) (46) (49) Hyperplasia 6 (12%) 3 (7%) 4 (8%) Pituitary Gland (49) (48) (49) Hyperplasia 1 (2%) Pars Distalis, Angiectasis 29 (59%) 28 (58%) 22 (45%) Pars Distalis, Cyst 5 (10%) 5 (10%) 9 (18%) Pars Distalis, Hyperplasia 11 (22%) 14 (29%) 11 (22%) Pars Intermedia, Angiectasis 1 (2%) Pars Intermedia, Cyst 1 (2%) Thyroid Gland (50) (50) (50) Hyperplasia 1 (2%) C-Cell, Hyperplasia 10 (20%) 14 (28%) 11 (22%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (47) (44) Necrosis 1 (2%) 4 (9%) Ovary (50) (49) (50) Cyst 2 (4%) 5 (10%) 3 (6%) Uterus (48) (50) (50) Endometrium, Hyperplasia 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (50) (50) (50) Mediastinal, Infiltration Cellular, Histiocyte 1 (2%) 2 (4%) Lymph Node, Mesenteric (49) (50) (49) Degeneration, Cystic 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 2 (4%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Spleen (50) (49) (50) Fibrosis 1 (2%) 2 (4%) Hematopoietic Cell Proliferation 30 (60%) 23 (47%) 31 (62%) Infiltration Cellular, Histiocyte 3 (6%) 1 (2%) 1 (2%) Pigmentation 28 (56%) 15 (31%) 31 (62%) Thrombosis 1 (2%) Thymus (47) (42) (43) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (37) (47) Galactocele 14 (29%) 7 (19%) 9 (19%) Acinus, Hyperplasia 3 (6%) 6 (16%) 5 (11%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) Hyperostosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) Hemorrhage 2 (4%) 1 (2%) 2 (4%) Spinal Cord (1) (2) Hemorrhage 1 (50%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) Infiltration Cellular, Histiocyte 9 (18%) 16 (32%) 8 (16%) Alveolar Epithelium, Hyperplasia 3 (6%) Nose (50) (49) (48) Fungus 1 (2%) Inflammation, Acute 2 (4%) 2 (4%) 4 (8%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (12) (8) (17) Hemorrhage 1 (8%) 1 (6%) Inflammation, Acute 2 (17%) 2 (25%) Lens, Cataract 5 (42%) 7 (88%) 8 (47%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATE 0.5% 1.0% D 61UF 61LF 61HF ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Retina, Atrophy 1 (8%) 1 (13%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) Cyst 1 (2%) Nephropathy 37 (76%) 44 (88%) 41 (82%) Urinary Bladder (48) (48) (50) Inflammation, Chronic Active 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 70 70 Scheduled Sacrifice 19 20 20 Early Deaths Moribund 24 17 18 Dead 6 4 3 Survivors Terminal Sacrifice 21 29 28 Wrong Sex 1 Animals Examined Microscopically 50 50 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (47) (48) (46) Parasite 1 (2%) Intestine Large, Colon (48) (44) (45) Diverticulum 1 (2%) Parasite 4 (8%) 5 (11%) Intestine Large, Rectum (47) (47) (47) Parasite 1 (2%) 2 (4%) Thrombosis 1 (2%) Liver (50) (50) (49) Angiectasis 4 (8%) 1 (2%) 4 (8%) Angiectasis, Focal 1 (2%) 1 (2%) Basophilic Focus 17 (34%) 21 (42%) 16 (33%) Clear Cell Focus 6 (12%) 5 (10%) 10 (20%) Cyst 1 (2%) Degeneration, Cystic 2 (4%) 3 (6%) 4 (8%) Eosinophilic Focus 5 (10%) 2 (4%) 6 (12%) Fatty Change, Diffuse 3 (6%) 1 (2%) Fatty Change, Focal 9 (18%) 8 (16%) 3 (6%) Hepatodiaphragmatic Nodule 7 (14%) 4 (8%) 5 (10%) Hyperplasia, Focal 1 (2%) 1 (2%) Mixed Cell Focus 1 (2%) 3 (6%) 1 (2%) Necrosis 1 (2%) 3 (6%) 3 (6%) Thrombosis 3 (6%) 1 (2%) Bile Duct, Hyperplasia 34 (68%) 36 (72%) 41 (84%) Mesentery (3) (5) (1) Fat, Inflammation, Chronic Active 1 (100%) Fat, Necrosis 2 (67%) 1 (100%) Pancreas (50) (48) (48) Acinus, Atrophy 22 (44%) 21 (44%) 23 (48%) Acinus, Basophilic Focus 5 (10%) 1 (2%) 3 (6%) Acinus, Hyperplasia 1 (2%) 3 (6%) 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Artery, Fibrosis 4 (8%) Artery, Inflammation, Chronic Active 2 (4%) Duct, Hyperplasia 1 (2%) Stomach, Forestomach (50) (48) (49) Acanthosis 2 (4%) 2 (4%) Hyperkeratosis 1 (2%) 1 (2%) 1 (2%) Necrosis 3 (6%) 1 (2%) Stomach, Glandular (49) (48) (48) Hyperplasia 1 (2%) Mineralization 3 (6%) 1 (2%) Necrosis 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (49) Cardiomyopathy 33 (66%) 42 (84%) 34 (69%) Thrombosis 2 (4%) 2 (4%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (50) (48) Hyperplasia 3 (6%) Adrenal Gland, Medulla (50) (49) (48) Hyperplasia 12 (24%) 16 (33%) 14 (29%) Islets, Pancreatic (48) (47) (48) Hyperplasia 3 (6%) Parathyroid Gland (47) (44) (37) Hyperplasia 2 (4%) 1 (2%) 1 (3%) Pituitary Gland (45) (49) (49) Pars Distalis, Angiectasis 8 (18%) 11 (22%) 10 (20%) Pars Distalis, Cyst 1 (2%) 1 (2%) 3 (6%) Pars Distalis, Hyperplasia 8 (18%) 13 (27%) 18 (37%) Pars Intermedia, Cyst 1 (2%) Thyroid Gland (49) (49) (48) C-Cell, Hyperplasia 4 (8%) 9 (18%) 6 (13%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (49) (50) (49) Granuloma Sperm 1 (2%) Preputial Gland (48) (50) (49) Inflammation, Chronic Active 11 (23%) 6 (12%) 5 (10%) Prostate (48) (49) (46) Epithelium, Hyperplasia 4 (8%) 1 (2%) 2 (4%) Testes (50) (50) (49) Interstitial Cell, Hyperplasia 20 (40%) 27 (54%) 29 (59%) Seminiferous Tubule, Atrophy 34 (68%) 31 (62%) 21 (43%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (50) (50) (49) Mediastinal, Fibrosis 1 (2%) Renal, Pigmentation 1 (2%) 1 (2%) Lymph Node, Mesenteric (49) (50) (47) Fibrosis 1 (2%) Infiltration Cellular, Histiocyte 10 (20%) 3 (6%) 7 (15%) Spleen (50) (50) (48) Cyst 1 (2%) Fibrosis 4 (8%) 2 (4%) 5 (10%) Hematopoietic Cell Proliferation 20 (40%) 12 (24%) 25 (52%) Thymus (41) (43) (47) Cyst 1 (2%) Epithelial Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (28) (18) (26) Galactocele 2 (7%) 2 (11%) 2 (8%) Acinus, Hyperplasia 7 (25%) 6 (33%) 5 (19%) Skin (48) (50) (47) Acanthosis 1 (2%) 1 (2%) Cyst Epithelial Inclusion 2 (4%) 3 (6%) Hyperkeratosis 2 (4%) 2 (4%) 4 (9%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05057-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC HC YELLOW 4 Date: 09/08/94 Route: DOSED FEED Time: 04:26:02 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATE 0.25% 0.5% D 61 UM 61LM 61HM ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (49) Hemorrhage 2 (4%) 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (49) Fibrosis 2 (4%) 2 (4%) Infiltration Cellular, Histiocyte 6 (12%) 6 (12%) 5 (10%) Inflammation, Acute 2 (4%) 1 (2%) Metaplasia, Osseous 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 4 (8%) 2 (4%) Nose (47) (50) (49) Fungus 2 (4%) 1 (2%) 1 (2%) Inflammation, Acute 4 (9%) 4 (8%) 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (6) (4) (2) Inflammation, Acute 1 (17%) Eye (6) (6) (12) Hemorrhage 1 (17%) Lens, Cataract 4 (67%) 4 (67%) 6 (50%) Retina, Atrophy 2 (33%) 3 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (49) Cyst 3 (6%) 2 (4%) 4 (8%) Hydronephrosis 2 (4%) Nephropathy 49 (98%) 49 (98%) 47 (96%) Urinary Bladder (48) (48) (47) Calculus Gross Observation 1 (2%) Calculus Micro Observation Only 2 (4%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------