TDMS Study 56111-04 Pathology Tables
NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 FINAL/MICE Facility: Battelle Columbus Laboratory Chemical CAS #: 14371-10-9 Lock Date: 06/28/00 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: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 50 Early Deaths Natural Death 5 6 9 5 3 Moribund Sacrifice 2 3 4 1 4 Survivors Terminal Sacrifice 42 41 36 44 43 Natural Death 1 1 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) (50) Hyperkeratosis 2 (4%) 1 (2%) 2 (4%) 1 (2%) 1 (2%) Gallbladder (50) (50) (50) (50) (50) Cyst 1 (2%) Inflammation 3 (6%) 6 (12%) 5 (10%) 5 (10%) 3 (6%) Intestine Small, Duodenum (50) (49) (50) (50) (50) Necrosis 1 (2%) Regeneration 1 (2%) Intestine Small, Jejunum (50) (50) (50) (50) (50) Ulcer 1 (2%) Epithelium, Atrophy 1 (2%) Peyer's Patch, Hyperplasia 1 (2%) Intestine Small, Ileum (50) (50) (50) (50) (50) Hyperplasia 1 (2%) Inflammation 1 (2%) Necrosis 1 (2%) Liver (50) (49) (50) (50) (50) Angiectasis 1 (2%) Atrophy 1 (2%) Basophilic Focus 1 (2%) Clear Cell Focus 1 (2%) 4 (8%) 2 (4%) 1 (2%) Eosinophilic Focus 3 (6%) 1 (2%) 2 (4%) Fatty Change 5 (10%) 4 (8%) 8 (16%) 4 (8%) 7 (14%) Hematopoietic Cell Proliferation 4 (8%) 6 (12%) 3 (6%) 2 (4%) 5 (10%) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) Inflammation 39 (78%) 42 (86%) 36 (72%) 38 (76%) 41 (82%) Mixed Cell Focus 2 (4%) 1 (2%) 3 (6%) Necrosis 6 (12%) 2 (4%) 2 (4%) 1 (2%) 3 (6%) Pigmentation 2 (4%) 3 (6%) 4 (8%) 2 (4%) 4 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Vacuolization Cytoplasmic 1 (2%) 1 (2%) 2 (4%) 1 (2%) Portal, Infiltration Cellular, Lymphocyte 26 (52%) 32 (65%) 25 (50%) 31 (62%) 26 (52%) Mesentery (3) (4) (5) (4) (1) Inflammation 1 (25%) Fat, Mineralization 2 (40%) 1 (100%) Fat, Necrosis 3 (75%) 2 (40%) 1 (25%) 1 (100%) Pancreas (50) (50) (50) (50) (50) Cyst 1 (2%) 1 (2%) 1 (2%) Inflammation 21 (42%) 25 (50%) 16 (32%) 24 (48%) 18 (36%) Salivary Glands (48) (50) (48) (49) (50) Atrophy 1 (2%) Inflammation 25 (52%) 32 (64%) 27 (56%) 27 (55%) 27 (54%) Mineralization 1 (2%) Stomach, Forestomach (50) (50) (50) (50) (50) Hyperkeratosis 3 (6%) 1 (2%) 1 (2%) 2 (4%) Hyperplasia 1 (2%) 1 (2%) Inflammation 1 (2%) Ulcer 1 (2%) 2 (4%) Stomach, Glandular (50) (50) (50) (50) (50) Inflammation 1 (2%) Mineralization 1 (2%) 2 (4%) 1 (2%) 1 (2%) 3 (6%) Tooth (2) (1) (1) Malformation 1 (50%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) (50) Aorta, Inflammation 1 (2%) 1 (2%) 1 (2%) Heart (49) (50) (50) (50) (50) Cardiomyopathy 1 (2%) 1 (2%) 2 (4%) Inflammation 1 (2%) 1 (2%) 2 (4%) 1 (2%) 2 (4%) Mineralization 1 (2%) 1 (2%) 1 (2%) 1 (2%) Artery, Inflammation 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) (50) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) Hyperplasia 2 (4%) 2 (4%) 6 (12%) 2 (4%) 2 (4%) Hypertrophy 4 (8%) 4 (8%) 2 (4%) 2 (4%) 1 (2%) Pigmentation 32 (64%) 34 (68%) 26 (52%) 32 (64%) 29 (58%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Vacuolization Cytoplasmic 36 (72%) 34 (68%) 31 (62%) 37 (74%) 33 (66%) Subcapsular, Hyperplasia 50 (100%) 49 (98%) 50 (100%) 50 (100%) 49 (98%) Adrenal Medulla (49) (50) (50) (50) (50) Hyperplasia 3 (6%) 1 (2%) 3 (6%) 2 (4%) Islets, Pancreatic (50) (50) (50) (50) (50) Hyperplasia 1 (2%) 3 (6%) 4 (8%) 2 (4%) Parathyroid Gland (41) (44) (40) (41) (44) Cyst 1 (2%) Pituitary Gland (48) (49) (50) (49) (50) Angiectasis 1 (2%) Cyst 1 (2%) 1 (2%) 2 (4%) Inflammation 1 (2%) Pars Distalis, Hyperplasia 5 (10%) 5 (10%) 6 (12%) 2 (4%) 4 (8%) Thyroid Gland (48) (50) (49) (50) (50) Inflammation 2 (4%) Follicle, Cyst 7 (15%) 3 (6%) 4 (8%) 10 (20%) 4 (8%) Follicular Cell, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (49) (50) (49) (50) Cyst 1 (2%) Inflammation 32 (64%) 35 (71%) 30 (60%) 36 (73%) 33 (66%) Inflammation, Suppurative 1 (2%) Ovary (50) (50) (50) (49) (50) Angiectasis 1 (2%) 1 (2%) 1 (2%) Cyst 13 (26%) 9 (18%) 8 (16%) 11 (22%) 11 (22%) Cyst, Multiple 1 (2%) Inflammation 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) Mineralization 1 (2%) 2 (4%) 1 (2%) 1 (2%) 3 (6%) Oviduct (1) (1) (2) (3) (4) Inflammation 1 (100%) 1 (25%) Uterus (50) (50) (50) (50) (50) Angiectasis 1 (2%) 1 (2%) Hydrometra 1 (2%) 1 (2%) Inflammation 1 (2%) 7 (14%) 3 (6%) 2 (4%) 6 (12%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Ulcer 1 (2%) Endometrium, Hyperplasia, Cystic 43 (86%) 42 (84%) 46 (92%) 41 (82%) 48 (96%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) (50) Hyperplasia 11 (22%) 10 (20%) 10 (20%) 12 (24%) 12 (24%) Infiltration Cellular, Lymphocyte 1 (2%) Lymph Node (7) (5) (7) (10) (7) Lumbar, Infiltration Cellular, Plasma Cell 1 (14%) Renal, Ectasia 1 (14%) Lymph Node, Mandibular (46) (47) (45) (49) (47) Atrophy 2 (4%) Hemorrhage 1 (2%) Hyperplasia 1 (2%) 1 (2%) Lymph Node, Mesenteric (49) (49) (50) (49) (50) Angiectasis 1 (2%) Atrophy 1 (2%) Ectasia 1 (2%) Hemorrhage 1 (2%) Hyperplasia 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) Inflammation 1 (2%) Spleen (48) (49) (50) (50) (50) Hematopoietic Cell Proliferation 11 (23%) 16 (33%) 15 (30%) 9 (18%) 11 (22%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) Pigmentation 1 (2%) Lymphoid Follicle, Atrophy 2 (4%) 2 (4%) Lymphoid Follicle, Hyperplasia 2 (4%) 4 (8%) 1 (2%) 4 (8%) Thymus (46) (47) (46) (47) (47) Atrophy 5 (11%) 2 (4%) 3 (7%) 2 (4%) 1 (2%) Hyperplasia 1 (2%) Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) (50) Hyperplasia 1 (2%) 1 (2%) Inflammation 1 (2%) Duct, Dilatation 1 (2%) 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Skin (50) (50) (50) (50) (50) Hyperkeratosis 1 (2%) Subcutaneous Tissue, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) Myelofibrosis 24 (48%) 27 (54%) 23 (46%) 34 (68%) 38 (76%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (50) (50) (50) (50) Infiltration Cellular, Lymphocyte 1 (2%) Choroid Plexus, Infiltration Cellular, Lymphocyte 1 (2%) Choroid Plexus, Inflammation 1 (2%) Medulla, Degeneration 1 (2%) Meninges, Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) Meninges, Inflammation 2 (4%) Spinal Cord (1) Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (50) Infiltration Cellular, Lymphocyte 1 (2%) 1 (2%) Inflammation 1 (2%) 3 (6%) Inflammation, Granulomatous 1 (2%) Metaplasia, Osseous 1 (2%) Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%) 1 (2%) Perivascular, Infiltration Cellular, Mononuclear Cell 1 (2%) 1 (2%) Nose (49) (50) (50) (50) (50) Foreign Body 1 (2%) 1 (2%) Inflammation 2 (4%) 5 (10%) 3 (6%) 4 (8%) 2 (4%) Glands, Inflammation, Focal, Granulomatous 1 (2%) Nasolacrimal Duct, Inflammation 2 (4%) 1 (2%) Olfactory Epithelium, Degeneration, Hyaline 17 (35%) 23 (46%) 25 (50%) 22 (44%) Olfactory Epithelium, Pigmentation 8 (16%) 46 (92%) Trachea (48) (50) (49) (50) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (1) Cornea, Hyperplasia 1 (100%) Cornea, Inflammation 1 (100%) 1 (100%) Harderian Gland (2) (1) (4) (5) Inflammation 2 (100%) 1 (25%) 2 (40%) Lacrimal Gland (1) Inflammation 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) (50) Atrophy 1 (2%) 1 (2%) Cyst 1 (2%) Hydronephrosis 1 (2%) 1 (2%) 1 (2%) Infarct 1 (2%) 1 (2%) 2 (4%) Infiltration Cellular, Lymphocyte 37 (74%) 44 (88%) 39 (78%) 42 (84%) 37 (74%) Inflammation 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) Metaplasia, Osseous 1 (2%) 1 (2%) 3 (6%) 1 (2%) Mineralization 4 (8%) 4 (8%) 1 (2%) 2 (4%) 6 (12%) Necrosis 1 (2%) Nephropathy 7 (14%) 11 (22%) 4 (8%) 12 (24%) 8 (16%) Artery, Inflammation 1 (2%) Papilla, Necrosis 1 (2%) Renal Tubule, Dilatation 24 (48%) 25 (50%) 30 (60%) 22 (44%) 32 (64%) Urinary Bladder (50) (50) (50) (50) (50) Inflammation 34 (68%) 33 (66%) 39 (78%) 33 (66%) 33 (66%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 50 Early Deaths Natural Death 6 3 4 9 Moribund Sacrifice 2 1 Survivors Terminal Sacrifice 43 45 46 39 49 Natural Death 1 2 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (50) (50) Hyperkeratosis 4 (8%) 2 (4%) 2 (4%) 4 (8%) Gallbladder (50) (50) (50) (50) (49) Inflammation 2 (4%) 4 (8%) 2 (4%) 2 (4%) 4 (8%) Intestine Large, Colon (50) (50) (50) (50) (50) Epithelium, Hyperplasia 1 (2%) Intestine Large, Rectum (50) (50) (50) (50) (50) Edema 1 (2%) Intestine Large, Cecum (50) (50) (50) (50) (50) Lymphoid Tissue, Hyperplasia 1 (2%) Intestine Small, Duodenum (50) (50) (50) (50) (49) Epithelium, Hyperplasia 1 (2%) Intestine Small, Jejunum (50) (50) (50) (50) (50) Atrophy 1 (2%) Cyst 1 (2%) Diverticulum 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation 1 (2%) Peyer's Patch, Hyperplasia 2 (4%) Intestine Small, Ileum (50) (50) (50) (50) (50) Peyer's Patch, Hyperplasia 1 (2%) Liver (50) (50) (50) (50) (50) Angiectasis 1 (2%) 1 (2%) Basophilic Focus 2 (4%) 1 (2%) 1 (2%) 1 (2%) Clear Cell Focus 2 (4%) 3 (6%) 3 (6%) 1 (2%) Cyst 1 (2%) Eosinophilic Focus 3 (6%) 1 (2%) 3 (6%) 2 (4%) 1 (2%) Fatty Change 3 (6%) 3 (6%) 4 (8%) 4 (8%) 2 (4%) Hematopoietic Cell Proliferation 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: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation 26 (52%) 33 (66%) 34 (68%) 28 (56%) 27 (54%) Mitotic Alteration 1 (2%) Mixed Cell Focus 3 (6%) 5 (10%) 3 (6%) 3 (6%) 6 (12%) Necrosis 3 (6%) 6 (12%) 4 (8%) 4 (8%) 3 (6%) Pigmentation 1 (2%) 1 (2%) 1 (2%) 1 (2%) Vacuolization Cytoplasmic 1 (2%) Bile Duct, Cyst 1 (2%) Centrilobular, Degeneration 1 (2%) Portal, Infiltration Cellular, Lymphocyte 1 (2%) 3 (6%) 6 (12%) 8 (16%) 3 (6%) Mesentery (2) (1) Fat, Inflammation 1 (50%) Fat, Necrosis 1 (50%) Pancreas (50) (50) (50) (50) (50) Atrophy 1 (2%) Cyst 2 (4%) Inflammation 8 (16%) 10 (20%) 8 (16%) 14 (28%) 10 (20%) Salivary Glands (50) (50) (50) (49) (50) Atrophy 3 (6%) 1 (2%) Inflammation 30 (60%) 31 (62%) 33 (66%) 26 (53%) 29 (58%) Mineralization 2 (4%) Stomach, Forestomach (48) (50) (50) (48) (50) Hyperkeratosis 2 (4%) 2 (4%) 3 (6%) Hyperplasia 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) (50) Mineralization 1 (2%) Ulcer 1 (2%) Tooth (1) (1) (2) Malformation 1 (100%) 1 (100%) 2 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (49) (50) (50) (50) Aorta, Inflammation 1 (2%) 1 (2%) Aorta, Thrombosis 1 (2%) Heart (50) (50) (50) (50) (50) Cardiomyopathy 1 (2%) 2 (4%) 1 (2%) 2 (4%) 1 (2%) Inflammation 1 (2%) 1 (2%) 1 (2%) Mineralization 5 (10%) Artery, Inflammation 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (50) (50) (49) (50) Fibrosis 1 (2%) Hyperplasia 1 (2%) Hypertrophy 23 (47%) 23 (46%) 22 (44%) 24 (49%) 19 (38%) Subcapsular, Hyperplasia 39 (80%) 46 (92%) 43 (86%) 44 (90%) 42 (84%) Adrenal Medulla (49) (50) (50) (49) (50) Hyperplasia 1 (2%) Islets, Pancreatic (50) (50) (50) (50) (50) Atrophy 1 (2%) Hyperplasia 4 (8%) 4 (8%) 5 (10%) 3 (6%) 4 (8%) Pituitary Gland (48) (50) (49) (50) (49) Angiectasis 1 (2%) Cyst 2 (4%) 1 (2%) 3 (6%) Pars Distalis, Hyperplasia 5 (10%) 5 (10%) 6 (12%) 4 (8%) 5 (10%) Thyroid Gland (50) (49) (50) (50) (50) Inflammation 1 (2%) 1 (2%) Follicle, Cyst 6 (12%) 4 (8%) 4 (8%) 5 (10%) 5 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (1) (1) Inflammation 1 (100%) 1 (100%) Epididymis (50) (50) (50) (50) (50) Inflammation 1 (2%) 1 (2%) 1 (2%) 1 (2%) Mineralization 3 (6%) 2 (4%) 2 (4%) Preputial Gland (50) (50) (50) (50) (50) Inflammation 26 (52%) 29 (58%) 31 (62%) 27 (54%) 22 (44%) Duct, Ectasia 15 (30%) 20 (40%) 27 (54%) 17 (34%) 13 (26%) Duct, Hyperplasia, Squamous 1 (2%) Testes (50) (50) (50) (50) (50) Mineralization 1 (2%) 3 (6%) 3 (6%) 1 (2%) Germinal Epithelium, Degeneration 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Bone Marrow (50) (50) (50) (50) (50) Hyperplasia 17 (34%) 14 (28%) 19 (38%) 20 (40%) 13 (26%) Necrosis 1 (2%) Lymph Node (3) (2) (2) (3) (2) Mediastinal, Hyperplasia 1 (33%) Lymph Node, Mandibular (49) (49) (49) (46) (48) Atrophy 1 (2%) 1 (2%) 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Pigmentation, Hemosiderin 1 (2%) Lymph Node, Mesenteric (48) (49) (46) (46) (50) Angiectasis 1 (2%) Atrophy 3 (6%) 1 (2%) 2 (4%) Ectasia 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 1 (2%) Hemorrhage 1 (2%) Hyperplasia 2 (4%) 1 (2%) Infiltration Cellular, Mast Cell 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) 1 (2%) 1 (2%) Inflammation 1 (2%) 1 (2%) Mineralization 1 (2%) Spleen (50) (50) (50) (49) (50) Hematopoietic Cell Proliferation 7 (14%) 8 (16%) 10 (20%) 8 (16%) 5 (10%) Hemorrhage 1 (2%) Hyperplasia 1 (2%) 1 (2%) Lymphoid Follicle, Atrophy 1 (2%) 1 (2%) 1 (2%) 1 (2%) Thymus (44) (43) (44) (44) (49) Atrophy 2 (5%) 3 (7%) 3 (7%) 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (50) (50) Inflammation 1 (2%) Subcutaneous Tissue, Edema 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) Myelofibrosis 1 (2%) 1 (2%) 1 (2%) 1 (2%) Skeletal Muscle (1) Inflammation 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) Hemorrhage 1 (2%) Infiltration Cellular, Lymphocyte 1 (2%) Cerebellum, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (50) Inflammation 1 (2%) 1 (2%) 3 (6%) 1 (2%) Inflammation, Granulomatous 1 (2%) Metaplasia, Osseous 1 (2%) Pigmentation, Hemosiderin 1 (2%) Alveolar Epithelium, Hyperplasia 4 (8%) 2 (4%) 7 (14%) 5 (10%) Perivascular, Infiltration Cellular, Mononuclear Cell 1 (2%) Nose (48) (48) (48) (48) (50) Foreign Body 1 (2%) 1 (2%) 3 (6%) 3 (6%) Inflammation 3 (6%) 2 (4%) 6 (13%) 4 (8%) Nasolacrimal Duct, Foreign Body 2 (4%) 1 (2%) Nasolacrimal Duct, Inflammation 2 (4%) 2 (4%) 1 (2%) 3 (6%) Olfactory Epithelium, Degeneration, Hyaline 2 (4%) 1 (2%) Olfactory Epithelium, Pigmentation 3 (6%) 26 (52%) Olfactory Epithelium, Respiratory Epithelium, Degeneration 1 (2%) Trachea (50) (50) (50) (50) (50) Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (4) (4) (4) (1) (3) Inflammation 1 (25%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) (50) Atrophy 1 (2%) Cyst 2 (4%) 3 (6%) 3 (6%) 3 (6%) Cytoplasmic Alteration 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 56111-04 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 14:40:37 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Fibrosis 1 (2%) Infarct 2 (4%) 5 (10%) 2 (4%) 2 (4%) Infiltration Cellular, Lymphocyte 39 (78%) 39 (78%) 42 (84%) 40 (80%) 44 (88%) Inflammation 2 (4%) 2 (4%) 1 (2%) Metaplasia, Osseous 2 (4%) 1 (2%) 3 (6%) 2 (4%) Mineralization 42 (84%) 44 (88%) 49 (98%) 45 (90%) 46 (92%) Nephropathy 46 (92%) 47 (94%) 46 (92%) 38 (76%) 42 (84%) Artery, Inflammation 1 (2%) 1 (2%) Glomerulus, Dilatation 1 (2%) Renal Tubule, Dilatation 6 (12%) 7 (14%) 5 (10%) 8 (16%) 9 (18%) Renal Tubule, Hyperplasia 1 (2%) 1 (2%) Renal Tubule, Pigmentation 1 (2%) Urinary Bladder (50) (50) (50) (50) (50) Inflammation 20 (40%) 16 (32%) 20 (40%) 18 (36%) 21 (42%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------