TDMS Study 05130-03 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) C. I. DIRECT BLUE 218 NTP Experiment-Test: 05130-03 Report: PEIRPT03 Study Type: CHRONIC Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 Facility: Microbiological Associates Chemical CAS #: 10401-500 Lock Date: 11/21/91 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: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 9 9 10 10 Early Deaths Moribund Sacrifice 12 15 13 16 Natural Death 4 7 6 9 Survivors Moribund Sacrifice 1 Terminal Sacrifice 35 28 31 25 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (48) (45) (49) (47) Mineralization, Focal 1 (2%) Liver (50) (50) (50) (50) Angiectasis, Focal 3 (6%) 1 (2%) Basophilic Focus 38 (76%) 28 (56%) 41 (82%) 30 (60%) Clear Cell Focus 11 (22%) 4 (8%) 16 (32%) 12 (24%) Congestion 2 (4%) 1 (2%) 3 (6%) Cyst 1 (2%) Degeneration, Cystic, Focal 2 (4%) 1 (2%) Developmental Malformation 1 (2%) 5 (10%) 1 (2%) Eosinophilic Focus 2 (4%) 2 (4%) 3 (6%) 3 (6%) Fatty Change, Diffuse 4 (8%) 5 (10%) 2 (4%) 1 (2%) Fatty Change, Focal 14 (28%) 11 (22%) 9 (18%) 18 (36%) Hematopoietic Cell Proliferation 3 (6%) 1 (2%) Hemorrhage, Focal 1 (2%) Hepatodiaphragmatic Nodule 4 (8%) 4 (8%) 2 (4%) 1 (2%) Hyperplasia, Focal 4 (8%) 1 (2%) 1 (2%) Inflammation, Chronic, Focal 11 (22%) 9 (18%) 8 (16%) 10 (20%) Inflammation, Focal, Granulomatous 1 (2%) 2 (4%) 1 (2%) Mixed Cell Focus 2 (4%) 2 (4%) 4 (8%) Necrosis, Focal 2 (4%) 1 (2%) 3 (6%) Bile Duct, Dilatation, Focal 1 (2%) Bile Duct, Hyperplasia, Focal 3 (6%) 1 (2%) 2 (4%) 2 (4%) Centrilobular, Necrosis 2 (4%) Vein, Dilatation 1 (2%) 1 (2%) Mesentery (8) (6) (3) (6) Fat, Necrosis, Focal 8 (100%) 3 (50%) 2 (67%) 5 (83%) Pancreas (50) (48) (50) (48) Accessory Spleen 1 (2%) Acinus, Atrophy, Diffuse 1 (2%) 1 (2%) Acinus, Atrophy, Focal 15 (30%) 9 (19%) 9 (18%) 13 (27%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Ectopic Liver, Focal 1 (2%) Artery, Inflammation, Focal 1 (2%) Duct, Hyperplasia, Focal 1 (2%) Salivary Glands (50) (50) (50) (50) Inflammation, Chronic 1 (2%) Stomach, Forestomach (50) (49) (50) (49) Acanthosis, Focal 2 (4%) 2 (4%) 3 (6%) 3 (6%) Hyperplasia, Basal Cell, Focal 1 (2%) 1 (2%) 5 (10%) 11 (22%) Inflammation, Acute, Focal 2 (4%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) 1 (2%) Mineralization, Focal 1 (2%) Ulcer 1 (2%) 1 (2%) 1 (2%) Ulcer, Focal 2 (4%) 2 (4%) 2 (4%) 2 (4%) Stomach, Glandular (50) (48) (50) (48) Erosion, Focal 1 (2%) 1 (2%) Inflammation, Chronic Active, Focal 1 (2%) Ulcer, Focal 1 (2%) Tongue (1) Acanthosis, Focal 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Cardiomyopathy 22 (44%) 20 (40%) 21 (42%) 14 (28%) Atrium, Thrombosis 2 (4%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (49) Angiectasis, Focal 2 (4%) 5 (10%) 13 (26%) 7 (14%) Congestion 2 (4%) Cyst 1 (2%) 1 (2%) Degeneration, Cystic, Focal 2 (4%) 1 (2%) Hematopoietic Cell Proliferation, Focal 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Focal 4 (8%) 3 (6%) 7 (14%) 6 (12%) Hypertrophy, Focal 2 (4%) 3 (6%) 2 (4%) 4 (8%) Necrosis, Focal 2 (4%) Vacuolization Cytoplasmic, Diffuse 2 (4%) Vacuolization Cytoplasmic, Focal 18 (36%) 21 (42%) 16 (32%) 18 (37%) Adrenal Medulla (49) (50) (47) (49) Degeneration 1 (2%) Hyperplasia 7 (14%) 5 (10%) 6 (13%) 3 (6%) Bilateral, Hyperplasia 2 (4%) 1 (2%) 1 (2%) Islets, Pancreatic (50) (48) (50) (48) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%) 1 (2%) Parathyroid Gland (45) (43) (39) (44) Cyst 1 (2%) Pituitary Gland (50) (47) (49) (47) Hemorrhage, Focal 1 (2%) Pars Distalis, Angiectasis 2 (4%) 1 (2%) Pars Distalis, Angiectasis, Focal 1 (2%) Pars Distalis, Cyst 10 (20%) 10 (21%) 7 (14%) 11 (23%) Pars Distalis, Hyperplasia, Focal 13 (26%) 9 (19%) 9 (18%) 14 (30%) Thyroid Gland (50) (50) (49) (49) Inflammation 1 (2%) 1 (2%) C-Cell, Hyperplasia, Diffuse 1 (2%) C-Cell, Hyperplasia, Focal 10 (20%) 4 (8%) 6 (12%) 11 (22%) Follicle, Dilatation, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (48) (49) (47) Hyperplasia 3 (6%) 3 (6%) Inflammation, Chronic 2 (4%) 1 (2%) Inflammation, Suppurative 3 (6%) 1 (2%) 2 (4%) Bilateral, Duct, Dilatation 1 (2%) Duct, Dilatation 8 (17%) 12 (25%) 15 (31%) 9 (19%) Ovary (50) (50) (50) (50) Congestion 1 (2%) Cyst 3 (6%) 9 (18%) 5 (10%) 4 (8%) Bilateral, Cyst 1 (2%) Uterus (50) (50) (50) (50) Cyst 5 (10%) 7 (14%) 8 (16%) 6 (12%) Cyst, Multiple 2 (4%) 3 (6%) 2 (4%) Dilatation 3 (6%) 5 (10%) 6 (12%) Hypoplasia 1 (2%) Inflammation, Acute 1 (2%) Vagina (1) (1) (2) (3) Cyst 2 (100%) Hyperplasia, Focal, Squamous 1 (50%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (49) (50) (49) Atrophy 7 (14%) 4 (8%) 10 (20%) 8 (16%) Hyperplasia 1 (2%) Lymph Node (7) (12) (6) (14) Axillary, Hyperplasia, Lymphoid 1 (7%) Axillary, Hyperplasia, Plasma Cell 1 (17%) Iliac, Hyperplasia, Plasma Cell 1 (8%) Mediastinal, Hemorrhage 1 (14%) 2 (17%) 3 (50%) 4 (29%) Mediastinal, Infiltration Cellular, Histiocyte 1 (8%) Pancreatic, Infiltration Cellular, Histiocyte 1 (7%) Renal, Hemorrhage 2 (29%) 1 (8%) 1 (17%) 2 (14%) Lymph Node, Mandibular (49) (50) (50) (50) Cyst 3 (6%) Hemorrhage 3 (6%) 1 (2%) 3 (6%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Hyperplasia, Plasma Cell 3 (6%) 1 (2%) 3 (6%) Lymph Node, Mesenteric (50) (50) (50) (50) Hemorrhage 6 (12%) 4 (8%) 3 (6%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Spleen (50) (49) (50) (48) Hematopoietic Cell Proliferation 1 (2%) 2 (4%) 1 (2%) Inflammation, Chronic, Focal 1 (2%) Thymus (48) (49) (42) (45) Congestion 1 (2%) Cyst, Multiple 1 (2%) Hemorrhage 1 (2%) 2 (4%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) Degeneration, Focal 1 (2%) Galactocele 13 (26%) 14 (28%) 10 (20%) 17 (34%) Hyperplasia, Focal 1 (2%) 1 (2%) 4 (8%) Inflammation, Acute, Focal 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic, Focal 1 (2%) 2 (4%) 1 (2%) Duct, Dilatation 2 (4%) 1 (2%) Skin (50) (50) (50) (50) Cyst Epithelial Inclusion 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Hyperostosis 5 (10%) 2 (4%) 5 (10%) 1 (2%) Inflammation, Acute 1 (2%) Femur, Osteoporosis 1 (2%) Skeletal Muscle (1) (1) Diaphragm, Ectopic Tissue 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage, Focal 1 (2%) 2 (4%) Hydrocephalus 1 (2%) 6 (12%) 3 (6%) 5 (10%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) Inflammation, Focal 1 (2%) Meninges, Angiectasis, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 1 (2%) 2 (4%) 5 (10%) Hemorrhage, Focal 1 (2%) 3 (6%) 2 (4%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) 2 (4%) Infiltration Cellular, Focal, Histiocyte 10 (20%) 7 (14%) 7 (14%) 11 (22%) Inflammation, Focal 9 (18%) 6 (12%) 11 (22%) 8 (16%) Alveolar Epithelium, Hyperplasia, Focal 1 (2%) 1 (2%) 1 (2%) 1 (2%) Arteriole, Mineralization, Focal 1 (2%) Nose (50) (50) (50) (50) Foreign Body 1 (2%) 1 (2%) Fungus 1 (2%) 1 (2%) 6 (12%) 8 (16%) Hemorrhage 1 (2%) 2 (4%) Inflammation, Acute 2 (4%) 3 (6%) 2 (4%) 3 (6%) Inflammation, Chronic Active 6 (12%) 6 (12%) 9 (18%) 9 (18%) Inflammation, Subacute 2 (4%) 5 (10%) 3 (6%) 4 (8%) Goblet Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (4) (6) Hemorrhage 1 (25%) Inflammation, Acute 1 (17%) Phthisis Bulbi 1 (50%) Bilateral, Lens, Cataract 2 (50%) 3 (50%) Bilateral, Retina, Atrophy 2 (50%) 3 (50%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Lens, Cataract 1 (25%) 1 (17%) Retina, Atrophy 1 (50%) 1 (25%) 1 (17%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Congestion 1 (2%) Cyst 1 (2%) 1 (2%) Cyst, Multiple 1 (2%) Hemorrhage, Focal 1 (2%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) Mineralization, Focal 32 (64%) 25 (50%) 28 (56%) 34 (68%) Nephropathy 39 (78%) 38 (76%) 41 (82%) 40 (80%) Pigmentation, Focal 34 (68%) 24 (48%) 28 (56%) 42 (84%) Bilateral, Hydronephrosis 1 (2%) Urethra (1) Cyst 1 (100%) Urinary Bladder (48) (48) (50) (49) Hemorrhage 1 (2%) Mucosa, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 10 9 Early Deaths Natural Death 7 3 5 9 Moribund Sacrifice 13 22 16 18 Survivors Terminal Sacrifice 30 25 29 24 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (46) (49) (49) (49) Hyperplasia, Focal, Lymphoid 1 (2%) Liver (50) (50) (50) (50) Angiectasis, Focal 2 (4%) 7 (14%) 2 (4%) Basophilic Focus 30 (60%) 26 (52%) 34 (68%) 18 (36%) Clear Cell Focus 13 (26%) 13 (26%) 19 (38%) 17 (34%) Congestion 3 (6%) 4 (8%) 4 (8%) 1 (2%) Degeneration, Cystic, Focal 15 (30%) 13 (26%) 18 (36%) 25 (50%) Developmental Malformation 2 (4%) 1 (2%) Eosinophilic Focus 9 (18%) 11 (22%) 15 (30%) 20 (40%) Fatty Change, Diffuse 1 (2%) 5 (10%) 1 (2%) Fatty Change, Focal 11 (22%) 11 (22%) 12 (24%) 16 (32%) Hematopoietic Cell Proliferation 1 (2%) Hepatodiaphragmatic Nodule 1 (2%) Hyperplasia, Focal 1 (2%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) Inflammation, Chronic, Focal 6 (12%) 2 (4%) 5 (10%) 2 (4%) Mixed Cell Focus 4 (8%) 1 (2%) 7 (14%) Necrosis, Focal 2 (4%) 3 (6%) 1 (2%) 3 (6%) Pigmentation, Focal 1 (2%) 1 (2%) Bile Duct, Cyst 1 (2%) 2 (4%) 1 (2%) Bile Duct, Fibrosis 1 (2%) Bile Duct, Hyperplasia, Focal 6 (12%) 3 (6%) 9 (18%) 2 (4%) Centrilobular, Atrophy, Focal 1 (2%) Centrilobular, Necrosis 1 (2%) Vein, Dilatation 1 (2%) Mesentery (5) (5) (7) (4) Fat, Necrosis, Focal 4 (80%) 5 (100%) 5 (71%) 3 (75%) Pancreas (50) (50) (50) (50) Accessory Spleen 1 (2%) Inflammation, Acute, Focal 1 (2%) Acinus, Atrophy, Diffuse 1 (2%) 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Atrophy, Focal 28 (56%) 26 (52%) 29 (58%) 26 (52%) Acinus, Cytoplasmic Alteration, Focal 1 (2%) Acinus, Hyperplasia, Focal 1 (2%) Acinus, Vacuolization Cytoplasmic, Focal 1 (2%) Artery, Inflammation, Focal 1 (2%) 1 (2%) Pharynx (1) (9) Palate, Hyperplasia, Focal, Squamous 2 (22%) Palate, Inflammation, Chronic Active 1 (100%) Salivary Glands (50) (50) (50) (50) Atrophy, Focal 1 (2%) Hyperplasia, Focal 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Acanthosis, Focal 1 (2%) 1 (2%) Hyperplasia, Basal Cell, Focal 2 (4%) 10 (20%) 19 (38%) Hyperplasia, Focal, Plasma Cell 1 (2%) Hyperplasia, Focal, Squamous 1 (2%) 1 (2%) 6 (12%) 4 (8%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) Inflammation, Chronic Active, Focal 2 (4%) 2 (4%) Ulcer, Focal 4 (8%) 3 (6%) 3 (6%) Stomach, Glandular (50) (50) (50) (50) Cyst 1 (2%) Erosion, Focal 2 (4%) 1 (2%) Hyperplasia, Basal Cell, Focal 1 (2%) Inflammation, Acute, Focal 1 (2%) Ulcer, Focal 3 (6%) Tooth (1) (1) Gingiva, Inflammation, Chronic Active 1 (100%) Peridontal Tissue, Inflammation, Focal 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Cardiomyopathy 37 (74%) 31 (62%) 38 (76%) 32 (64%) Mineralization, Focal 1 (2%) 1 (2%) 1 (2%) Atrium, Dilatation 2 (4%) 3 (6%) 3 (6%) Atrium, Thrombosis 6 (12%) 2 (4%) 1 (2%) 1 (2%) Valve, Degeneration 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (50) (50) (50) Angiectasis, Focal 1 (2%) Congestion 1 (2%) 1 (2%) Cyst 1 (2%) Cyst, Multiple 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Degeneration, Cystic, Focal 2 (4%) Hemorrhage 1 (2%) 1 (2%) Hyperplasia, Focal 6 (12%) 6 (12%) 6 (12%) 2 (4%) Vacuolization Cytoplasmic, Focal 8 (16%) 12 (24%) 3 (6%) 12 (24%) Adrenal Medulla (49) (50) (50) (50) Cyst 1 (2%) Hyperplasia 16 (33%) 12 (24%) 14 (28%) 8 (16%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) Bilateral, Hyperplasia 4 (8%) 3 (6%) 3 (6%) 1 (2%) Islets, Pancreatic (50) (50) (50) (50) Hyperplasia, Focal 5 (10%) 4 (8%) 7 (14%) 10 (20%) Parathyroid Gland (43) (47) (46) (45) Hyperplasia 1 (2%) 2 (4%) Bilateral, Hyperplasia 1 (2%) 2 (4%) Pituitary Gland (50) (50) (48) (50) Angiectasis, Focal 1 (2%) 1 (2%) Pigmentation, Focal 1 (2%) Pars Distalis, Cyst 3 (6%) 2 (4%) 3 (6%) Pars Distalis, Hyperplasia, Focal 12 (24%) 16 (32%) 11 (23%) 18 (36%) Pars Distalis, Hypertrophy, Focal 1 (2%) Pars Nervosa, Hyperplasia, Focal 1 (2%) Thyroid Gland (50) (50) (50) (50) C-Cell, Hyperplasia, Focal 7 (14%) 6 (12%) 10 (20%) 4 (8%) Follicle, Dilatation, Focal 4 (8%) Follicular Cell, Hyperplasia, Focal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Degeneration, Focal 31 (62%) 38 (76%) 37 (74%) 33 (66%) Preputial Gland (50) (50) (50) (49) Hyperplasia 3 (6%) 1 (2%) 2 (4%) 1 (2%) Inflammation, Chronic 1 (2%) Inflammation, Suppurative 5 (10%) 3 (6%) 2 (4%) 1 (2%) Duct, Dilatation 10 (20%) 17 (34%) 9 (18%) 11 (22%) Prostate (50) (50) (50) (49) Abscess 1 (2%) 2 (4%) Atrophy 10 (20%) 7 (14%) 11 (22%) 13 (27%) Degeneration, Focal 1 (2%) 1 (2%) Hyperplasia, Focal 3 (6%) 3 (6%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) 2 (4%) 4 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Inflammation, Focal, Granulomatous 3 (6%) 2 (4%) Inflammation, Focal, Suppurative 3 (6%) 2 (4%) 4 (8%) 4 (8%) Inflammation, Suppurative 3 (6%) Vacuolization Cytoplasmic, Focal 1 (2%) Seminal Vesicle (50) (50) (50) (49) Abscess 1 (2%) Dilatation 1 (2%) Hyperplasia, Focal 1 (2%) Inflammation, Chronic, Focal 1 (2%) Testes (50) (50) (50) (50) Atrophy 4 (8%) 3 (6%) 4 (8%) 9 (18%) Cyst 2 (4%) Cyst, Multiple 1 (2%) Mineralization, Focal 1 (2%) Artery, Inflammation, Focal 1 (2%) Bilateral, Atrophy 2 (4%) Interstitial Cell, Hyperplasia, Focal 4 (8%) 2 (4%) 1 (2%) 5 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Atrophy 1 (2%) Hyperplasia 1 (2%) 3 (6%) 4 (8%) Lymph Node (15) (16) (23) (18) Axillary, Hyperplasia, Plasma Cell 1 (6%) Bronchial, Hemorrhage 1 (7%) Bronchial, Infiltration Cellular, Histiocyte 1 (6%) Iliac, Cyst 1 (6%) Iliac, Infiltration Cellular, Histiocyte 1 (6%) Inguinal, Cyst 1 (6%) Lumbar, Hemorrhage 1 (4%) 2 (11%) Lumbar, Hyperplasia, Plasma Cell 1 (6%) Lumbar, Infiltration Cellular, Histiocyte 2 (9%) Mediastinal, Cyst 1 (4%) Mediastinal, Hemorrhage 5 (33%) 2 (13%) 5 (22%) 2 (11%) Mediastinal, Hyperplasia, Plasma Cell 2 (13%) 1 (4%) Mediastinal, Infiltration Cellular, Histiocyte 1 (4%) 1 (6%) Pancreatic, Hemorrhage 1 (4%) 2 (11%) Pancreatic, Infiltration Cellular, Histiocyte 1 (4%) Renal, Hemorrhage 1 (7%) 1 (6%) 1 (4%) 1 (6%) Renal, Infiltration Cellular, Histiocyte 1 (6%) Lymph Node, Mandibular (48) (50) (49) (50) Cyst 3 (6%) 2 (4%) 6 (12%) 3 (6%) Hemorrhage 3 (6%) 2 (4%) 3 (6%) 2 (4%) Hyperplasia, Plasma Cell 9 (19%) 10 (20%) 4 (8%) 3 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. 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DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Lymph Node, Mesenteric (49) (50) (50) (50) Cyst 1 (2%) Edema 1 (2%) Hemorrhage 2 (4%) 2 (4%) 1 (2%) 3 (6%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Spleen (50) (50) (50) (49) Congestion 1 (2%) 1 (2%) Depletion Cellular 1 (2%) Fibrosis, Focal 2 (4%) 1 (2%) 4 (8%) 4 (8%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 2 (4%) Pigmentation, Hemosiderin 1 (2%) Capsule, Cyst 1 (2%) Thymus (48) (40) (49) (48) Congestion 1 (2%) Hemorrhage 1 (2%) 1 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (49) (50) (46) Galactocele 6 (13%) 7 (14%) 1 (2%) 1 (2%) Hyperplasia, Focal 1 (2%) 2 (4%) 3 (6%) 2 (4%) Inflammation, Acute, Focal 1 (2%) Inflammation, Chronic, Focal 1 (2%) Pigmentation, Focal 1 (2%) Skin (50) (50) (50) (50) Acanthosis, Focal 1 (2%) Subcutaneous Tissue, Inflammation, Acute 1 (2%) Subcutaneous Tissue, Inflammation, Chronic Active, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) Fibrous Osteodystrophy 1 (2%) 1 (2%) Hyperostosis 1 (2%) Hyperplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Gliosis, Focal 1 (2%) Hemorrhage, Focal 1 (2%) Hydrocephalus 4 (8%) 4 (8%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Infiltration Cellular, Focal, Lymphocyte 1 (2%) Mineralization, Focal 1 (2%) Necrosis, Focal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Congestion 6 (12%) 1 (2%) 1 (2%) 3 (6%) Hemorrhage, Focal 1 (2%) Infiltration Cellular, Focal, Lymphocyte 3 (6%) 3 (6%) Infiltration Cellular, Focal, Histiocyte 6 (12%) 4 (8%) 6 (12%) 4 (8%) Inflammation, Focal 7 (14%) 2 (4%) 7 (14%) 7 (14%) Alveolar Epithelium, Hyperplasia, Focal 2 (4%) 1 (2%) 3 (6%) 2 (4%) Nose (50) (50) (49) (50) Congestion 1 (2%) 1 (2%) Foreign Body 5 (10%) 2 (4%) 3 (6%) 3 (6%) Fungus 7 (14%) 6 (12%) 16 (33%) 11 (22%) Hemorrhage 2 (4%) 1 (2%) 1 (2%) 1 (2%) Inflammation, Acute 7 (14%) 2 (4%) 1 (2%) Inflammation, Chronic Active 9 (18%) 10 (20%) 20 (41%) 14 (28%) Inflammation, Subacute 5 (10%) 1 (2%) 3 (6%) 3 (6%) Glands, Dilatation, Focal 1 (2%) Olfactory Epithelium, Necrosis, Focal 1 (2%) Trachea (50) (50) (50) (50) Inflammation, Chronic Active, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (5) (4) (3) (2) Inflammation, Chronic 1 (25%) Phthisis Bulbi 1 (20%) 1 (25%) Cornea, Degeneration, Focal 1 (33%) Cornea, Inflammation 1 (20%) Lens, Cataract 3 (60%) 1 (25%) 1 (33%) 1 (50%) Lens, Inflammation, Focal, Subacute 1 (20%) Retina, Atrophy 1 (20%) 2 (50%) 1 (50%) Zymbal's Gland (48) (48) (48) (48) Hyperplasia 1 (2%) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94 Route: DOSED FEED Time: 01:29:33 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Cyst 2 (4%) 2 (4%) Hydronephrosis 1 (2%) Infarct 1 (2%) Mineralization, Focal 1 (2%) Nephropathy 48 (96%) 50 (100%) 50 (100%) 46 (92%) Pigmentation, Focal 12 (24%) 11 (22%) 15 (30%) 23 (46%) Pelvis, Inflammation, Suppurative 1 (2%) Urinary Bladder (50) (50) (50) (50) Abscess 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------