TDMS Study 05130-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) C. I. DIRECT BLUE 218 NTP Experiment-Test: 05130-02 Report: PEIRPT03 Study Type: CHRONIC Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 Facility: Microbiological Associates Chemical CAS #: 10401-500 Lock Date: 10/29/91 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: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Moribund Sacrifice 5 8 1 3 Natural Death 4 2 2 5 Moribund 3 2 Accidently Killed 1 Survivors Terminal Sacrifice 37 40 46 38 Missing 1 1 1 Animals Examined Microscopically 49 50 49 49 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (47) (45) (46) (42) Dilatation 1 (2%) 1 (2%) Intestine Large, Cecum (47) (50) (48) (45) Hyperplasia, Lymphoid 1 (2%) Intestine Small, Duodenum (46) (50) (48) (46) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Intussusception 1 (2%) Liver (49) (50) (49) (49) Angiectasis, Focal 4 (8%) 3 (6%) Basophilic Focus 4 (8%) 2 (4%) 6 (12%) 7 (14%) Clear Cell Focus 2 (4%) 2 (4%) 1 (2%) 12 (24%) Cyst 1 (2%) Eosinophilic Focus 11 (22%) 7 (14%) 11 (22%) 21 (43%) Fatty Change, Focal 1 (2%) 1 (2%) 1 (2%) 2 (4%) Infiltration Cellular, Focal, Lymphocyte 2 (4%) 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic, Focal 1 (2%) Mixed Cell Focus 1 (2%) 1 (2%) Necrosis, Focal 2 (4%) 1 (2%) 2 (4%) Centrilobular, Cytomegaly 1 (2%) Mesentery (6) (5) (3) (5) Fat, Necrosis, Focal 6 (100%) 2 (40%) 3 (100%) 3 (60%) Pancreas (49) (50) (48) (49) Accessory Spleen 1 (2%) 1 (2%) Fibrosis, Focal 1 (2%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) Inflammation, Chronic Active, Focal 2 (4%) 1 (2%) Acinar Cell, Atrophy 2 (4%) Acinar Cell, Hypertrophy, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Duct, Dilatation 2 (4%) 2 (4%) Salivary Glands (49) (50) (49) (48) Arteriole, Inflammation, Chronic, Multifocal 1 (2%) Stomach, Forestomach (49) (50) (48) (49) Hyperplasia, Focal 1 (2%) 2 (4%) Ulcer, Focal 2 (4%) 2 (4%) 1 (2%) Stomach, Glandular (49) (50) (48) (49) Inflammation, Acute, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (49) (50) (49) (49) Cardiomyopathy 1 (2%) Arteriole, Inflammation, Chronic, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (49) (48) (48) Cyst 1 (2%) 3 (6%) Cytoplasmic Alteration, Focal 1 (2%) 4 (8%) 1 (2%) Degeneration, Focal 1 (2%) 1 (2%) Hemorrhage, Focal 7 (15%) 1 (2%) Hyperplasia, Focal 1 (2%) Hypertrophy, Focal 1 (2%) 1 (2%) Vacuolization Cytoplasmic, Focal 1 (2%) Adrenal Medulla (49) (49) (48) (47) Congestion 1 (2%) Degeneration, Focal 1 (2%) Hyperplasia, Focal 1 (2%) 1 (2%) Islets, Pancreatic (49) (50) (48) (49) Hyperplasia, Focal 1 (2%) 2 (4%) Parathyroid Gland (33) (34) (40) (40) Infiltration Cellular, Focal, Lymphocyte 1 (3%) Pituitary Gland (48) (50) (49) (45) Pars Distalis, Angiectasis, Focal 2 (4%) Pars Distalis, Cyst 1 (2%) 1 (2%) 1 (2%) Pars Distalis, Hyperplasia, Focal 6 (13%) 11 (22%) 7 (14%) 3 (7%) Thyroid Gland (49) (50) (49) (49) Infiltration Cellular, Focal, Lymphocyte 2 (4%) Inflammation, Chronic Active, Focal 1 (2%) Arteriole, Inflammation, Chronic, Focal 1 (2%) C-Cell, Hyperplasia, Focal 1 (2%) 1 (2%) Follicle, Dilatation, Focal 2 (4%) 1 (2%) Follicular Cell, Hyperplasia, Focal 11 (22%) 9 (18%) 7 (14%) 6 (12%) Follicular Cell, Hypertrophy, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (1) (1) Inflammation, Chronic Active 1 (100%) 1 (100%) Duct, Dilatation 1 (100%) Ovary (47) (50) (48) (49) Abscess 2 (4%) Angiectasis 1 (2%) 3 (6%) Cyst 12 (26%) 17 (34%) 15 (31%) 28 (57%) Ectopic Tissue 1 (2%) Hematocyst 1 (2%) 3 (6%) 2 (4%) Hemorrhage, Focal 1 (2%) Hyperplasia, Tubular 1 (2%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) 1 (2%) Inflammation, Chronic, Focal 2 (4%) Mineralization, Focal 1 (2%) 1 (2%) Pigmentation, Focal 1 (2%) Bilateral, Abscess 1 (2%) Follicle, Hyperplasia, Cystic, Focal 1 (2%) Uterus (49) (50) (49) (49) Dilatation 13 (27%) 12 (24%) 15 (31%) 9 (18%) Ectopic Tissue, Focal 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active 2 (4%) Thrombosis, Focal 1 (2%) Endometrium, Hyperplasia, Cystic 31 (63%) 42 (84%) 38 (78%) 31 (63%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (50) (49) (49) Angiectasis, Focal 1 (2%) Congestion 1 (2%) Hyperplasia 5 (10%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) Lymph Node (9) (10) (8) (7) Iliac, Hyperplasia, Lymphoid 1 (11%) Iliac, Hyperplasia, Plasma Cell 1 (11%) 1 (14%) Lumbar, Hyperplasia, Lymphoid 3 (33%) 1 (10%) 1 (13%) Lumbar, Hyperplasia, Plasma Cell 1 (11%) Mediastinal, Hyperplasia, Lymphoid 1 (11%) 1 (14%) Mediastinal, Hyperplasia, Plasma Cell 1 (11%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Renal, Hyperplasia, Lymphoid 2 (22%) Renal, Hyperplasia, Plasma Cell 2 (22%) 1 (14%) Lymph Node, Mandibular (49) (48) (48) (47) Congestion 1 (2%) Cyst 2 (4%) 3 (6%) 2 (4%) 3 (6%) Edema 1 (2%) Hemorrhage 1 (2%) 1 (2%) Hyperplasia, Lymphoid 3 (6%) 7 (15%) 4 (8%) 2 (4%) Hyperplasia, Plasma Cell 1 (2%) 2 (4%) 2 (4%) 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Inflammation, Acute 1 (2%) Lymph Node, Mesenteric (46) (48) (47) (46) Angiectasis, Focal 1 (2%) Hemorrhage 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 5 (11%) 2 (4%) 1 (2%) 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Necrosis 1 (2%) 1 (2%) Spleen (48) (50) (49) (49) Amyloid Deposition, Focal 1 (2%) Depletion Lymphoid 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 10 (21%) 9 (18%) 3 (6%) 6 (12%) Hyperplasia, Lymphoid 6 (13%) 5 (10%) 10 (20%) 5 (10%) Thymus (46) (48) (48) (46) Atrophy 1 (2%) Cyst 1 (2%) 2 (4%) 1 (2%) Depletion Lymphoid 1 (2%) 1 (2%) Hemorrhage, Focal 1 (2%) Hyperplasia, Lymphoid 1 (2%) 3 (6%) 2 (4%) Necrosis 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (49) (50) (49) (49) Acanthosis, Focal 1 (2%) Inflammation, Acute, Focal 1 (2%) 1 (2%) Inflammation, Chronic Active, Focal 1 (2%) 4 (8%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (50) (49) (49) Fibrous Osteodystrophy 1 (2%) Intervertebral Disc, Dysplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (50) (49) (49) Hemorrhage, Focal 1 (2%) Hydrocephalus 1 (2%) Mineralization, Focal 29 (59%) 45 (90%) 34 (69%) 38 (78%) Necrosis, Focal 1 (2%) Artery, Inflammation, Chronic, Focal 1 (2%) Spinal Cord (1) Infiltration Cellular, Focal, Histiocyte 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (49) (50) (49) (49) Congestion 1 (2%) 1 (2%) 1 (2%) Hemorrhage, Focal 1 (2%) 1 (2%) 1 (2%) Hemorrhage, Multifocal 1 (2%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) Infiltration Cellular, Focal, Histiocyte 2 (4%) Alveolar Epithelium, Hyperplasia, Focal 2 (4%) Arteriole, Hypertrophy, Focal 1 (2%) Interstitium, Inflammation, Focal 1 (2%) 3 (6%) Nose (49) (50) (49) (49) Congestion 1 (2%) Inflammation, Acute, Focal 2 (4%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) (1) Arteriole, Inflammation, Chronic, Focal 1 (50%) Pinna, Inflammation, Chronic Active, Focal 1 (100%) Eye (2) (1) (1) Cornea, Inflammation, Chronic 2 (100%) Lens, Cataract 1 (100%) 1 (100%) Zymbal's Gland (38) (38) (37) (32) Inflammation, Acute, Focal 1 (3%) 1 (3%) Inflammation, Chronic Active 1 (3%) Duct, Dilatation 1 (3%) 1 (3%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (49) (49) Infarct, Chronic, Focal 1 (2%) 1 (2%) Infiltration Cellular, Focal, Lymphocyte 1 (2%) 2 (4%) 2 (4%) 1 (2%) Metaplasia, Focal, Osseous 2 (4%) 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE CONTROL 1000 PPM 3000 PPM 10000PPM FEMALE LOW FEM MID FEM HIGH FEM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Nephropathy 4 (8%) 3 (6%) 5 (10%) 3 (6%) Artery, Inflammation, Chronic, Focal 1 (2%) Glomerulus, Inflammation, Chronic 1 (2%) 1 (2%) Renal Tubule, Dilatation, Focal 2 (4%) Urinary Bladder (48) (50) (48) (49) Dilatation 1 (2%) 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic Active, Focal 2 (4%) Arteriole, Inflammation, Chronic, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 9 10 10 10 Early Deaths Accidently Killed 1 Natural Death 3 2 5 4 Moribund Sacrifice 2 2 3 1 Survivors Terminal Sacrifice 44 46 42 45 Missing 1 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (45) (47) (46) (47) Hyperplasia 1 (2%) Inflammation, Acute 2 (4%) Intestine Large, Colon (48) (50) (50) (49) Diverticulum 1 (2%) Intestine Large, Cecum (48) (49) (48) (48) Hyperplasia, Lymphoid 1 (2%) Intestine Small, Duodenum (48) (48) (47) (49) Hyperplasia, Lymphoid 1 (2%) Inflammation, Acute, Focal 1 (2%) Intestine Small, Jejunum (49) (49) (49) (49) Hyperplasia, Lymphoid 1 (2%) Liver (50) (50) (50) (50) Angiectasis, Focal 1 (2%) 1 (2%) Basophilic Focus 7 (14%) 5 (10%) 4 (8%) 9 (18%) Clear Cell Focus 8 (16%) 5 (10%) 5 (10%) 4 (8%) Cytomegaly, Focal 1 (2%) Developmental Malformation 1 (2%) Eosinophilic Focus 13 (26%) 12 (24%) 10 (20%) 28 (56%) Fatty Change, Focal 1 (2%) 3 (6%) 4 (8%) Hematopoietic Cell Proliferation 1 (2%) Infarct, Chronic 1 (2%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) Leukocytosis 1 (2%) 1 (2%) Mixed Cell Focus 3 (6%) 5 (10%) 2 (4%) 1 (2%) Necrosis, Focal 4 (8%) 3 (6%) Mesentery (3) (1) Fat, Necrosis, Focal 3 (100%) Pancreas (49) (50) (50) (50) Cyst 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinar Cell, Atrophy 1 (2%) 1 (2%) Stomach, Forestomach (50) (50) (50) (50) Hyperplasia, Focal 1 (2%) 3 (6%) 1 (2%) Inflammation, Chronic Active, Focal 1 (2%) Ulcer, Focal 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) Hyperplasia, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) Cardiomyopathy 1 (2%) Inflammation, Acute, Focal 1 (2%) Inflammation, Chronic Active, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 1 (2%) Atrophy 1 (2%) Hemorrhage, Focal 1 (2%) Hyperplasia, Focal 1 (2%) 2 (4%) 2 (4%) 3 (6%) Hypertrophy, Focal 1 (2%) 1 (2%) 3 (6%) 4 (8%) Adrenal Medulla (50) (50) (50) (50) Hyperplasia, Focal 1 (2%) 1 (2%) Islets, Pancreatic (49) (50) (50) (50) Hyperplasia, Focal 1 (2%) 1 (2%) Parathyroid Gland (41) (43) (42) (43) Cyst 1 (2%) Inflammation, Chronic, Focal 1 (2%) Pituitary Gland (49) (48) (48) (48) Pars Distalis, Cyst 1 (2%) 2 (4%) Pars Distalis, Hyperplasia, Focal 2 (4%) Pars Nervosa, Cyst 1 (2%) Thyroid Gland (50) (50) (50) (50) Follicle, Dilatation, Focal 1 (2%) 1 (2%) Follicular Cell, Hyperplasia, Focal 3 (6%) 1 (2%) 5 (10%) Follicular Cell, Hypertrophy, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (50) (50) Granuloma Sperm 2 (4%) 2 (4%) Inflammation, Chronic, Focal 1 (2%) 2 (4%) Preputial Gland (29) (23) (23) (21) Inflammation, Chronic Active 2 (7%) 2 (9%) 1 (5%) Duct, Dilatation 27 (93%) 23 (100%) 22 (96%) 21 (100%) Prostate (50) (49) (50) (50) Dilatation 1 (2%) Hyperplasia, Focal 2 (4%) 4 (8%) 6 (12%) 2 (4%) Seminal Vesicle (50) (50) (50) (50) Dilatation 2 (4%) 1 (2%) 1 (2%) Inflammation, Acute 1 (2%) Testes (50) (50) (50) (50) Angiectasis, Focal 1 (2%) Atrophy 1 (2%) Atrophy, Focal 1 (2%) Degeneration, Focal 1 (2%) 1 (2%) Seminiferous Tubule, Degeneration, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) Angiectasis, Focal 1 (2%) 1 (2%) Hyperplasia 1 (2%) 1 (2%) Lymph Node (4) (1) (2) (3) Hyperplasia, Lymphoid 1 (50%) Bronchial, Hyperplasia, Lymphoid 1 (25%) Mediastinal, Congestion 1 (33%) Renal, Hyperplasia, Lymphoid 1 (25%) Lymph Node, Mandibular (46) (49) (49) (48) Cyst 1 (2%) 1 (2%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 4 (9%) 4 (8%) 4 (8%) 1 (2%) Hyperplasia, Plasma Cell 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Lymph Node, Mesenteric (48) (49) (50) (50) Hemorrhage 3 (6%) 3 (6%) 2 (4%) Hyperplasia, Lymphoid 2 (4%) 4 (8%) 1 (2%) Hyperplasia, Plasma Cell 1 (2%) Necrosis 1 (2%) Spleen (49) (50) (50) (50) Developmental Malformation 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 3 (6%) 3 (6%) 4 (8%) Hyperplasia, Lymphoid 2 (4%) 4 (8%) 2 (4%) Lymphocyte, Necrosis, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Thymus (49) (45) (46) (42) Cyst 2 (4%) 2 (4%) 3 (7%) 2 (5%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) Inflammation, Chronic Active, Focal 1 (2%) 3 (6%) Subcutaneous Tissue, Abscess 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) Hemorrhage, Focal 1 (2%) 1 (2%) Mineralization, Focal 36 (72%) 42 (84%) 43 (86%) 43 (86%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Hemorrhage, Focal 1 (2%) Infiltration Cellular, Focal, Histiocyte 2 (4%) 1 (2%) Leukocytosis 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia, Focal 5 (10%) 2 (4%) 3 (6%) 2 (4%) Interstitium, Inflammation, Focal 4 (8%) 1 (2%) 3 (6%) 2 (4%) Nose (50) (50) (50) (50) Congestion 1 (2%) 1 (2%) Inflammation, Acute, Focal 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (2) Middle Ear, Inflammation, Chronic Active, Focal 1 (50%) Eye (1) (2) (2) Cornea, Inflammation, Chronic 1 (50%) 1 (50%) Lens, Cataract 1 (50%) Zymbal's Gland (39) (34) (42) (37) Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05130-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/16/94 Route: DOSED FEED Time: 23:49:52 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE CONTROL 1000 PPM 3000 PPM 10000PPM MALE LOW MALE MID MALE HIGHMALE ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Duct, Dilatation 1 (2%) 1 (3%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) Infarct, Chronic, Focal 2 (4%) Metaplasia, Focal, Osseous 1 (2%) Mineralization, Focal 1 (2%) Nephropathy 25 (50%) 20 (40%) 30 (60%) 19 (38%) Renal Tubule, Dilatation, Focal 1 (2%) 1 (2%) 3 (6%) 2 (4%) Urinary Bladder (50) (50) (50) (50) Dilatation 1 (2%) 1 (2%) Metaplasia, Focal, Osseous 1 (2%) Transitional Epithelium, Hyperplasia, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------