TDMS Study 05165-02 Pathology Tables
NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 Facility: Battelle Columbus Laboratory Chemical CAS #: 96-69-5 Lock Date: 01/10/92 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 9 9 10 10 Early Deaths Natural Death 7 9 11 11 Moribund Sacrifice 4 3 3 4 Survivors Natural Death 1 Terminal Sacrifice 39 38 36 35 Missing 1 Animals Examined Microscopically 60 59 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (59) (59) (60) (60) Necrosis, Focal 1 (2%) Liver (60) (59) (60) (60) Angiectasis 2 (3%) 1 (2%) Basophilic Focus 2 (3%) 4 (7%) 3 (5%) Clear Cell Focus 2 (3%) 3 (5%) Eosinophilic Focus 10 (17%) 8 (14%) 10 (17%) 7 (12%) Hematopoietic Cell Proliferation 2 (3%) 4 (7%) 1 (2%) Inflammation, Chronic Active 1 (2%) Necrosis 1 (2%) 1 (2%) Vacuolization Cytoplasmic 1 (2%) Bile Duct, Cyst 2 (3%) Bile Duct, Dilatation 1 (2%) Hepatocyte, Fatty Change 7 (12%) 6 (10%) 5 (8%) 6 (10%) Hepatocyte, Hypertrophy 2 (3%) Periportal, Inflammation, Chronic Active 1 (2%) Serosa, Inflammation, Chronic 1 (2%) Mesentery (5) (6) (4) (1) Fat, Inflammation, Chronic Active 4 (80%) 3 (50%) 1 (25%) 1 (100%) Pancreas (59) (59) (59) (60) Inflammation, Chronic Active 1 (2%) Acinus, Atrophy 1 (2%) 3 (5%) 2 (3%) Duct, Cyst 1 (2%) Pharynx (1) Submucosa, Palate, Infiltration Cellular, Mast Cell 1 (100%) Stomach, Forestomach (59) (59) (60) (60) Acanthosis, Multifocal 1 (2%) Ulcer 1 (2%) Stomach, Glandular (59) (59) (60) (60) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Necrosis 1 (2%) 1 (2%) Mucosa, Hyperplasia 1 (2%) Submucosa, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (59) (60) (60) Degeneration, Chronic 2 (3%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (59) (60) (60) Cyst 2 (3%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 2 (3%) 1 (2%) 1 (2%) Hypertrophy 3 (5%) 6 (10%) 5 (8%) 3 (5%) Capsule, Accessory Adrenal Cortical Nodule 1 (2%) 2 (3%) 1 (2%) Adrenal Medulla (58) (59) (60) (60) Hyperplasia 2 (3%) 1 (2%) 3 (5%) Parathyroid Gland (52) (54) (57) (57) Cyst 1 (2%) Pituitary Gland (57) (58) (59) (58) Pars Distalis, Angiectasis 2 (3%) Pars Distalis, Cyst 4 (7%) 3 (5%) Pars Distalis, Hyperplasia 9 (16%) 14 (24%) 13 (22%) 11 (19%) Pars Distalis, Hypertrophy 1 (2%) Pars Intermedia, Cyst 1 (2%) Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (60) (59) (59) (60) Cyst 1 (2%) Inflammation, Chronic Active 1 (2%) Ultimobranchial Cyst 1 (2%) Follicle, Cyst 2 (3%) 1 (2%) Follicle, Cyst, Multiple 1 (2%) Follicular Cell, Hyperplasia 4 (7%) 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (51) (45) (48) (44) Duct, Dilatation 1 (2%) 1 (2%) Ovary (59) (59) (59) (60) Angiectasis 1 (2%) Inflammation, Granulomatous 1 (2%) 1 (2%) Mineralization 2 (3%) 1 (2%) Thrombosis 1 (2%) Bilateral, Inflammation, Granulomatous 2 (3%) 1 (2%) Bilateral, Periovarian Tissue, Cyst 1 (2%) Bilateral, Follicle, Cyst 3 (5%) 2 (3%) 4 (7%) Follicle, Cyst 26 (44%) 22 (37%) 23 (39%) 21 (35%) Periovarian Tissue, Cyst 1 (2%) 3 (5%) 8 (13%) Periovarian Tissue, Inflammation, Granulomatous 1 (2%) Rete Ovarii, Hyperplasia 2 (3%) 1 (2%) Uterus (60) (59) (60) (60) Endometrium, Hyperplasia, Cystic, Glandular 57 (95%) 57 (97%) 52 (87%) 57 (95%) Endometrium, Vein, Thrombosis 2 (3%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (59) (60) (60) Myelofibrosis 21 (35%) 18 (31%) 23 (38%) 34 (57%) Femoral, Myelofibrosis 1 (2%) 1 (2%) Lymph Node (9) (7) (4) (7) Inguinal, Inflammation, Chronic Active 1 (14%) Mediastinal, Hyperplasia, Lymphoid 1 (14%) Mediastinal, Infiltration Cellular, Histiocyte 1 (11%) Mediastinal, Inflammation, Acute 1 (14%) Lymph Node, Mandibular (59) (59) (57) (60) Congestion 2 (3%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Histiocyte 6 (10%) Inflammation, Chronic Active 1 (2%) Lymphocyte, Necrosis 1 (2%) Lymph Node, Mesenteric (52) (51) (51) (52) Cyst 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Histiocytic, Macrophage 40 (77%) 33 (65%) 31 (61%) 42 (81%) Infiltration Cellular, Histiocyte 5 (10%) 3 (6%) 9 (18%) 9 (17%) Inflammation, Chronic Active 1 (2%) 1 (2%) Lymphatic, Cyst 1 (2%) Lymphocyte, Necrosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Spleen (60) (59) (60) (59) Depletion Lymphoid 2 (3%) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 8 (13%) 12 (20%) 7 (12%) 4 (7%) Inflammation, Chronic 1 (2%) Lymphocyte, Necrosis 1 (2%) Thymus (55) (52) (54) (58) Concretion 1 (2%) Depletion Lymphoid 6 (11%) 2 (4%) 8 (15%) 4 (7%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (59) (59) (58) (59) Hyperplasia, Cystic 2 (3%) 2 (3%) 2 (3%) Skin (60) (59) (60) (60) Inguinal, Ulcer 1 (2%) Subcutaneous Tissue, Hemorrhage 1 (2%) Subcutaneous Tissue, Inflammation, Acute 1 (2%) Tail, Ulcer 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (60) (59) (60) (60) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (59) (60) (60) Compression 1 (2%) 3 (5%) 3 (5%) Necrosis 1 (2%) Neuron, Degeneration 1 (2%) Peripheral Nerve (2) (1) (1) (4) Sciatic, Axon, Degeneration 2 (100%) 1 (100%) 1 (100%) 4 (100%) Spinal Cord (2) (1) (1) (4) Axon, Degeneration 1 (50%) 2 (50%) Lumbar, Axon, Nerve, Degeneration 1 (50%) 1 (100%) 4 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (59) (60) (60) Congestion 1 (2%) Hemorrhage, Focal 1 (2%) Inflammation, Acute 1 (2%) Alveolar Epithelium, Hyperplasia 2 (3%) Alveolar Epithelium, Hyperplasia, Macrophage 1 (2%) Mediastinum, Inflammation, Chronic Active 1 (2%) 1 (2%) Perivascular, Infiltration Cellular, Lymphocyte 4 (7%) 5 (8%) 3 (5%) 7 (12%) Perivascular, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) (1) Atrophy 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (59) (60) (60) Amyloid Deposition 1 (2%) 1 (2%) Metaplasia, Focal, Osseous 1 (2%) Nephropathy, Chronic 22 (37%) 27 (46%) 16 (27%) 18 (30%) Cortex, Cyst 1 (2%) Cortex, Infarct 1 (2%) 2 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 6 6 1 4 Moribund Sacrifice 2 2 1 Survivors Natural Death 1 1 Terminal Sacrifice 41 41 49 45 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Small, Jejunum (60) (60) (60) (60) Mucosa, Hyperplasia 1 (2%) Peyer's Patch, Hyperplasia, Lymphoid 1 (2%) Peyer's Patch, Ulcer, Chronic Active 1 (2%) Intestine Small, Ileum (60) (60) (59) (59) Peyer's Patch, Inflammation, Acute 1 (2%) Liver (60) (60) (60) (60) Basophilic Focus 1 (2%) Clear Cell Focus 6 (10%) 2 (3%) 2 (3%) Clear Cell Focus, Multiple 3 (5%) Congestion 1 (2%) Eosinophilic Focus 2 (3%) 3 (5%) 3 (5%) Hematopoietic Cell Proliferation 1 (2%) Infarct 1 (2%) Necrosis 2 (3%) 1 (2%) 1 (2%) 1 (2%) Thrombosis 1 (2%) 1 (2%) Vacuolization Cytoplasmic 6 (10%) 2 (3%) 3 (5%) 1 (2%) Bile Duct, Cyst 1 (2%) Bile Duct, Hyperplasia 1 (2%) Hepatocyte, Fatty Change 19 (32%) 17 (28%) 5 (8%) 6 (10%) Serosa, Fibrosis 1 (2%) Vein, Dilatation 1 (2%) Mesentery (1) (2) (1) Fat, Inflammation, Chronic Active 1 (100%) 2 (100%) Pancreas (60) (60) (60) (60) Acinus, Atrophy 1 (2%) 3 (5%) 1 (2%) 2 (3%) Acinus, Karyomegaly 1 (2%) Duct, Cyst 1 (2%) 1 (2%) Salivary Glands (60) (60) (60) (60) Acinus, Atrophy 1 (2%) Stomach, Forestomach (60) (60) (60) (60) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acanthosis 1 (2%) 1 (2%) Acanthosis, Multifocal 1 (2%) Stomach, Glandular (60) (60) (60) (60) Submucosa, Developmental Malformation 2 (3%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Aortic Valve, Thrombosis 1 (2%) Atrium, Thrombosis 1 (2%) Ventricle Right, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Accessory Adrenal Cortical Nodule 1 (2%) Ectopic Tissue 1 (2%) Hyperplasia 1 (2%) 4 (7%) Hypertrophy 30 (50%) 30 (50%) 26 (43%) 25 (42%) Vacuolization Cytoplasmic 1 (2%) Capsule, Accessory Adrenal Cortical Nodule 1 (2%) 1 (2%) Adrenal Medulla (60) (60) (60) (60) Hyperplasia 1 (2%) 1 (2%) Islets, Pancreatic (60) (60) (60) (60) Hyperplasia 3 (5%) 2 (3%) 1 (2%) Parathyroid Gland (59) (58) (56) (57) Cyst 2 (3%) 1 (2%) Pituitary Gland (55) (56) (58) (57) Craniopharyngeal Duct, Cyst 1 (2%) Pars Distalis, Cyst 1 (2%) 3 (5%) 2 (4%) Pars Distalis, Hyperplasia 1 (2%) Thyroid Gland (60) (60) (60) (60) Follicle, Cyst 3 (5%) 1 (2%) 1 (2%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (60) (60) Developmental Malformation 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (3%) 2 (3%) Preputial Gland (55) (49) (54) (51) Inflammation, Chronic Active 3 (5%) 2 (4%) 4 (7%) 2 (4%) Duct, Dilatation 27 (49%) 14 (29%) 16 (30%) 19 (37%) Seminal Vesicle (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) Testes (60) (60) (60) (60) Developmental Malformation 1 (2%) Mineralization 1 (2%) Spermatocele 1 (2%) Interstitial Cell, Hyperplasia 2 (3%) Seminiferous Tubule, Atrophy 2 (3%) 1 (2%) 1 (2%) 2 (3%) Seminiferous Tubule, Mineralization 2 (3%) Tunic, Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (59) (57) (57) (58) Depletion Lymphoid 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) 1 (2%) 1 (2%) Lymph Node, Mesenteric (58) (55) (58) (55) Congestion 1 (2%) 1 (2%) Depletion Lymphoid 2 (3%) 3 (5%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Histiocytic, Macrophage 48 (83%) 37 (67%) 44 (76%) 45 (82%) Infiltration Cellular, Histiocyte 3 (5%) 6 (11%) 9 (16%) 8 (15%) Spleen (60) (60) (60) (60) Angiectasis 1 (2%) Depletion Lymphoid 1 (2%) 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 5 (8%) 3 (5%) 4 (7%) 5 (8%) Hemorrhage 1 (2%) Thymus (56) (56) (56) (54) Angiectasis 1 (2%) Cyst 1 (2%) 1 (2%) Depletion Lymphoid 12 (21%) 6 (11%) 2 (4%) 3 (6%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (60) (60) (60) (60) Subcutaneous Tissue, Inflammation, Chronic Active 1 (2%) 1 (2%) Thoracic, Ulcer 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (58) Maxilla, Inflammation, Chronic Active, Necrotizing 1 (2%) Skeletal Muscle (60) (60) (60) (60) Diaphragm, Degeneration, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Peripheral Nerve (1) (1) Sciatic, Axon, Degeneration 1 (100%) Spinal Cord (1) Axon, Degeneration 1 (100%) Lumbar, Axon, Nerve, Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Inflammation, Chronic Active 1 (2%) Alveolar Epithelium, Hyperplasia 2 (3%) 4 (7%) 2 (3%) 3 (5%) Alveolar Epithelium, Hyperplasia, Macrophage 1 (2%) Alveolus, Hyperplasia, Macrophage 1 (2%) Perivascular, Infiltration Cellular, Lymphocyte 4 (7%) 5 (8%) 7 (12%) 10 (17%) Subpleura, Infiltration Cellular, Lymphocyte 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (2) (1) Atrophy 1 (100%) Cornea, Hyperplasia, Squamous 1 (50%) 2 (100%) Cornea, Inflammation, Chronic Active 1 (50%) 2 (100%) Harderian Gland (3) (4) (3) Hyperplasia 1 (25%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05165-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4 THIOBIS-(6-T-BUTYL-M-CRESOL) Date: 11/09/95 Route: DOSED FEED Time: 20:28:46 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 250 PPM 500 PPM 1000 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Hydronephrosis 1 (2%) 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Nephropathy, Chronic 56 (93%) 55 (92%) 60 (100%) 56 (93%) Cortex, Cyst 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------