NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 FINAL/MICE Facility: Battelle Columbus Laboratory Chemical CAS #: 14371-10-9 Lock Date: 06/01/00 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: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 50 Early Deaths Moribund Sacrifice 11 10 13 10 10 Natural Death 5 4 4 4 7 Survivors Terminal Sacrifice 33 36 33 35 33 Natural Death 1 Missing 1 Animals Examined Microscopically 50 50 50 49 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (50) (49) (50) Inflammation, Chronic 1 (2%) Intestine Large, Colon (50) (50) (50) (49) (50) Parasite Metazoan 1 (2%) 5 (10%) 4 (8%) 1 (2%) Intestine Large, Rectum (50) (50) (50) (49) (50) Parasite Metazoan 4 (8%) 1 (2%) 3 (6%) 1 (2%) Intestine Large, Cecum (50) (49) (50) (49) (50) Inflammation, Chronic Active 1 (2%) Intestine Small, Duodenum (50) (50) (50) (49) (50) Mineralization 1 (2%) Parasite Metazoan 1 (2%) Intestine Small, Jejunum (50) (50) (50) (49) (50) Inflammation, Chronic Active 1 (2%) Intestine Small, Ileum (50) (50) (50) (49) (50) Parasite Metazoan 1 (2%) Liver (50) (50) (50) (49) (50) Angiectasis 1 (2%) Basophilic Focus 42 (84%) 44 (88%) 42 (84%) 43 (88%) 44 (88%) Clear Cell Focus 1 (2%) 2 (4%) 2 (4%) Eosinophilic Focus 1 (2%) 1 (2%) Fibrosis 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 3 (6%) 2 (4%) 3 (6%) 1 (2%) Hepatodiaphragmatic Nodule 4 (8%) 5 (10%) 12 (24%) 9 (18%) 7 (14%) Infarct 1 (2%) Inflammation, Chronic Active 44 (88%) 41 (82%) 42 (84%) 42 (86%) 43 (86%) Mixed Cell Focus 26 (52%) 25 (50%) 24 (48%) 27 (55%) 20 (40%) Necrosis 5 (10%) 3 (6%) 4 (8%) 1 (2%) 6 (12%) Pigmentation 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Thrombosis 1 (2%) Bile Duct, Hyperplasia 21 (42%) 25 (50%) 28 (56%) 21 (43%) 18 (36%) Hepatocyte, Degeneration, Cystic 1 (2%) 1 (2%) Hepatocyte, Hyperplasia 1 (2%) 1 (2%) 2 (4%) Hepatocyte, Vacuolization Cytoplasmic 31 (62%) 32 (64%) 25 (50%) 14 (29%) 18 (36%) Mesentery (11) (9) (6) (9) (8) Hemorrhage 1 (13%) Inflammation, Chronic 1 (17%) Fat, Inflammation, Chronic 4 (36%) 8 (89%) 4 (67%) 8 (89%) 7 (88%) Fat, Mineralization 8 (73%) 5 (56%) 2 (33%) 5 (56%) 3 (38%) Fat, Necrosis 9 (82%) 7 (78%) 5 (83%) 9 (100%) 7 (88%) Fat, Pigmentation 1 (13%) Oral Mucosa (12) (11) (24) (18) (5) Foreign Body 11 (92%) 9 (82%) 24 (100%) 17 (94%) 4 (80%) Gingival, Hyperplasia, Squamous 1 (9%) Gingival, Inflammation, Chronic Active 5 (42%) 8 (73%) 8 (33%) 3 (17%) 1 (20%) Gingival, Necrosis 1 (20%) Pancreas (50) (50) (50) (49) (50) Basophilic Focus 1 (2%) Inflammation, Chronic Active 2 (4%) 1 (2%) Acinus, Atrophy 12 (24%) 14 (28%) 14 (28%) 5 (10%) 11 (22%) Acinus, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Duct, Cyst 8 (16%) 4 (8%) 4 (8%) 1 (2%) Salivary Glands (50) (50) (49) (49) (50) Atrophy 11 (22%) 19 (38%) 8 (16%) 5 (10%) 11 (22%) Basophilic Focus 10 (20%) 7 (14%) 6 (12%) 6 (12%) 3 (6%) Inflammation, Chronic Active 1 (2%) 1 (2%) 2 (4%) Mineralization 1 (2%) Vacuolization Cytoplasmic 1 (2%) Stomach, Forestomach (50) (50) (50) (49) (50) Inflammation, Chronic Active 1 (2%) 2 (4%) 1 (2%) Mineralization 1 (2%) Epithelium, Hyperkeratosis 2 (4%) 1 (2%) 1 (2%) Epithelium, Hyperplasia 1 (2%) 2 (4%) 2 (4%) Epithelium, Ulcer 1 (2%) 2 (4%) Stomach, Glandular (50) (50) (50) (49) (50) Inflammation, Chronic Active 2 (4%) Mineralization 1 (2%) Epithelium, Erosion 2 (4%) 1 (2%) Epithelium, Hyperplasia 1 (2%) Epithelium, Ulcer 2 (4%) Glands, Ectasia 39 (78%) 36 (72%) 36 (72%) 39 (80%) 38 (76%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (49) (50) Cardiomyopathy 36 (72%) 45 (90%) 45 (90%) 43 (88%) 44 (88%) Mineralization 1 (2%) 1 (2%) 1 (2%) Atrium, Thrombosis 1 (2%) Valve, Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (49) (50) Accessory Adrenal Cortical Nodule 1 (2%) 2 (4%) 1 (2%) 1 (2%) Angiectasis 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 5 (10%) 2 (4%) 1 (2%) Hyperplasia 10 (20%) 17 (34%) 9 (18%) 12 (24%) 10 (20%) Hypertrophy 1 (2%) 4 (8%) 2 (4%) 3 (6%) 2 (4%) Necrosis 1 (2%) 2 (4%) 1 (2%) 1 (2%) Vacuolization Cytoplasmic 20 (40%) 18 (36%) 25 (50%) 19 (39%) 20 (40%) Adrenal Medulla (50) (50) (50) (49) (50) Hyperplasia 3 (6%) 6 (12%) 3 (6%) 3 (6%) 3 (6%) Islets, Pancreatic (50) (50) (50) (49) (50) Hyperplasia 1 (2%) Pituitary Gland (50) (50) (50) (49) (50) Pars Distalis, Angiectasis 2 (4%) 2 (4%) 3 (6%) 1 (2%) Pars Distalis, Cyst 30 (60%) 27 (54%) 27 (54%) 19 (39%) 22 (44%) Pars Distalis, Hemorrhage 1 (2%) Pars Distalis, Hyperplasia 24 (48%) 19 (38%) 21 (42%) 23 (47%) 21 (42%) Pars Distalis, Mineralization 1 (2%) Pars Intermedia, Angiectasis 1 (2%) Pars Intermedia, Cyst 2 (4%) Pars Intermedia, Hyperplasia 1 (2%) 1 (2%) Thyroid Gland (50) (50) (49) (49) (50) Ectopic Thymus 1 (2%) Inflammation, Chronic 1 (2%) Ultimobranchial Cyst 1 (2%) 2 (4%) 1 (2%) C-Cell, Hyperplasia 23 (46%) 33 (66%) 23 (47%) 28 (57%) 21 (42%) Follicle, Cyst 2 (4%) 1 (2%) Follicular Cell, Hyperplasia 2 (4%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (49) (50) (50) (49) (50) Hyperplasia 11 (22%) 11 (22%) 17 (34%) 11 (22%) 7 (14%) Inflammation, Chronic Active 13 (27%) 9 (18%) 21 (42%) 15 (31%) 12 (24%) Mineralization 1 (2%) 1 (2%) Duct, Cyst 11 (22%) 16 (32%) 7 (14%) 9 (18%) 11 (22%) Ovary (50) (50) (50) (49) (50) Angiectasis 1 (2%) Atrophy 1 (2%) Cyst 9 (18%) 5 (10%) 5 (10%) 4 (8%) 2 (4%) Mineralization 1 (2%) 1 (2%) Granulosa Cell, Hyperplasia 1 (2%) Interstitial Cell, Hyperplasia 1 (2%) Uterus (50) (50) (50) (49) (50) Hemorrhage 1 (2%) Hydrometra 2 (4%) 2 (4%) 5 (10%) 5 (10%) 3 (6%) Inflammation, Chronic Active 1 (2%) 1 (2%) Metaplasia, Squamous 1 (2%) Cervix, Cyst, Squamous 1 (2%) Cervix, Epithelium, Hyperplasia 1 (2%) Endometrium, Hyperplasia, Cystic 2 (4%) 5 (10%) 2 (4%) 4 (8%) 4 (8%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (49) (50) Hyperplasia 15 (30%) 16 (32%) 13 (26%) 11 (22%) 13 (26%) Myelofibrosis 3 (6%) 2 (4%) 2 (4%) 4 (8%) Lymph Node (30) (25) (26) (24) (27) Deep Cervical, Ectasia 1 (3%) 1 (4%) 3 (13%) Deep Cervical, Hyperplasia, Lymphoid 1 (4%) 3 (13%) 3 (11%) Deep Cervical, Inflammation, Chronic 1 (4%) Deep Cervical, Pigmentation 1 (4%) Lumbar, Ectasia 1 (3%) Mediastinal, Ectasia 15 (50%) 17 (68%) 21 (81%) 20 (83%) 21 (78%) Mediastinal, Hyperplasia, Lymphoid 19 (63%) 20 (80%) 21 (81%) 20 (83%) 22 (81%) Mediastinal, Inflammation, Chronic 1 (4%) Mediastinal, Pigmentation 1 (3%) 4 (15%) 1 (4%) 2 (7%) Lymph Node, Mandibular (1) (2) (1) (2) Ectasia 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Hyperplasia, Lymphoid 1 (100%) Lymph Node, Mesenteric (50) (50) (50) (49) (50) Ectasia 2 (4%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Spleen (50) (50) (49) (49) (50) Atrophy 1 (2%) Hematopoietic Cell Proliferation 12 (24%) 5 (10%) 8 (16%) 3 (6%) 6 (12%) Hyperplasia, Lymphoid 2 (4%) 1 (2%) 1 (2%) Infarct 1 (2%) Pigmentation 1 (2%) 1 (2%) 2 (4%) Thymus (43) (49) (47) (48) (47) Ectopic Parathyroid Gland 4 (9%) 4 (8%) 3 (6%) 2 (4%) 6 (13%) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (49) (50) Cyst 5 (10%) 3 (6%) 3 (6%) 3 (6%) Cyst, Multiple 1 (2%) Hyperplasia, Cystic 43 (86%) 47 (94%) 45 (90%) 37 (76%) 42 (84%) Skin (50) (50) (50) (49) (50) Cyst Epithelial Inclusion 1 (2%) Fibrosis 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Epidermis, Hyperplasia 1 (2%) Epidermis, Ulcer 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (49) (50) Osteopetrosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (49) (50) Compression 2 (4%) 3 (6%) 3 (6%) 2 (4%) 5 (10%) Hemorrhage 2 (4%) 2 (4%) 3 (6%) Hydrocephalus 2 (4%) 5 (10%) 10 (20%) 5 (10%) 8 (16%) Inflammation, Chronic Active 1 (2%) Necrosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Meninges, Inflammation, Chronic Active 1 (2%) Spinal Cord (1) Hemorrhage 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (49) (50) Congestion 1 (2%) Fibrosis 1 (2%) 1 (2%) Inflammation, Chronic Active 31 (62%) 36 (72%) 40 (80%) 37 (76%) 33 (66%) Metaplasia, Squamous 1 (2%) Mineralization 45 (90%) 45 (90%) 47 (94%) 45 (92%) 44 (88%) Pigmentation 44 (88%) 47 (94%) 44 (88%) 44 (90%) 44 (88%) Alveolar Epithelium, Hyperplasia 12 (24%) 12 (24%) 15 (30%) 13 (27%) 9 (18%) Alveolar Epithelium, Metaplasia, Focal, Squamous 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 44 (88%) 47 (94%) 44 (88%) 44 (90%) 45 (90%) Nose (50) (50) (50) (49) (50) Foreign Body 1 (2%) Inflammation, Chronic Active 4 (8%) 1 (2%) 2 (4%) Thrombosis 2 (4%) 3 (6%) 1 (2%) Nasolacrimal Duct, Inflammation, Suppurative 4 (8%) 5 (10%) 3 (6%) 6 (12%) 2 (4%) Trachea (50) (50) (50) (49) (50) Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) (3) (1) (2) Lens, Cataract 1 (100%) 3 (100%) 2 (100%) Retina, Degeneration 1 (100%) 3 (100%) 2 (100%) Retina, Hemorrhage 1 (100%) Zymbal's Gland (1) (2) Cyst 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (49) (50) Accumulation, Hyaline Droplet 1 (2%) Atrophy 1 (2%) Cyst 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Hydronephrosis 1 (2%) Infarct 1 (2%) 1 (2%) Infiltration Cellular, Lipocyte 1 (2%) Mineralization 30 (60%) 38 (76%) 28 (56%) 33 (67%) 30 (60%) Nephropathy 39 (78%) 43 (86%) 41 (82%) 38 (78%) 40 (80%) Pigmentation 1 (2%) 1 (2%) Pelvis, Inflammation, Suppurative 1 (2%) Urinary Bladder (50) (50) (50) (49) (50) Transitional Epithelium, Hyperplasia 1 (2%) Transitional Epithelium, Metaplasia, Squamous 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 50 50 Early Deaths Moribund Sacrifice 14 13 11 11 6 Natural Death 7 6 3 12 3 Survivors Terminal Sacrifice 29 31 36 27 41 Animals Examined Microscopically 50 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (50) (50) (50) (50) Parasite Metazoan 3 (6%) 4 (8%) 3 (6%) 1 (2%) 1 (2%) Intestine Large, Rectum (50) (50) (50) (50) (50) Parasite Metazoan 10 (20%) 4 (8%) 5 (10%) 8 (16%) 4 (8%) Liver (50) (50) (50) (50) (50) Angiectasis 1 (2%) 1 (2%) Basophilic Focus 25 (50%) 26 (52%) 32 (64%) 23 (46%) 33 (66%) Clear Cell Focus 1 (2%) 1 (2%) 3 (6%) Eosinophilic Focus 2 (4%) 1 (2%) 2 (4%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 2 (4%) Hepatodiaphragmatic Nodule 2 (4%) 2 (4%) 1 (2%) 5 (10%) 4 (8%) Inflammation, Chronic Active 34 (68%) 38 (76%) 38 (76%) 31 (62%) 39 (78%) Mixed Cell Focus 18 (36%) 29 (58%) 32 (64%) 20 (40%) 32 (64%) Necrosis 2 (4%) 5 (10%) 2 (4%) 3 (6%) 5 (10%) Pigmentation 1 (2%) Thrombosis 1 (2%) Bile Duct, Cyst 1 (2%) 1 (2%) Bile Duct, Hyperplasia 45 (90%) 46 (92%) 45 (90%) 43 (86%) 43 (86%) Hepatocyte, Degeneration, Cystic 4 (8%) 7 (14%) 3 (6%) 4 (8%) 5 (10%) Hepatocyte, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 2 (4%) 1 (2%) Hepatocyte, Hypertrophy 1 (2%) Hepatocyte, Vacuolization Cytoplasmic 23 (46%) 37 (74%) 36 (72%) 32 (64%) 34 (68%) Portal, Fibrosis 1 (2%) Mesentery (14) (5) (8) (9) (12) Fat, Inflammation, Chronic 11 (79%) 2 (40%) 3 (38%) 6 (67%) 9 (75%) Fat, Mineralization 8 (57%) 2 (40%) 2 (25%) 5 (56%) 6 (50%) Fat, Necrosis 11 (79%) 2 (40%) 3 (38%) 8 (89%) 10 (83%) Oral Mucosa (13) (13) (14) (12) (24) Foreign Body 13 (100%) 12 (92%) 12 (86%) 10 (83%) 22 (92%) Gingival, Inflammation, Chronic Active 9 (69%) 4 (31%) 9 (64%) 6 (50%) 12 (50%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Pancreas (50) (50) (50) (50) (50) Basophilic Focus 1 (2%) 2 (4%) Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%) Metaplasia, Hepatocyte 1 (2%) Pigmentation 1 (2%) Acinus, Atrophy 13 (26%) 25 (50%) 20 (40%) 23 (46%) 16 (32%) Acinus, Hyperplasia 2 (4%) 1 (2%) Artery, Inflammation, Chronic Active 1 (2%) Duct, Cyst 2 (4%) 3 (6%) 7 (14%) 3 (6%) 10 (20%) Salivary Glands (50) (50) (50) (50) (50) Atrophy 8 (16%) 5 (10%) 7 (14%) 6 (12%) 1 (2%) Basophilic Focus 16 (32%) 19 (38%) 10 (20%) 18 (36%) 24 (48%) Hyperplasia 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Stomach, Forestomach (50) (50) (50) (50) (50) Diverticulum 1 (2%) Inflammation, Chronic Active 4 (8%) 3 (6%) 1 (2%) 1 (2%) Mineralization 1 (2%) Epithelium, Hyperkeratosis 2 (4%) 1 (2%) 2 (4%) 3 (6%) Epithelium, Hyperplasia 5 (10%) 3 (6%) 3 (6%) 3 (6%) 1 (2%) Epithelium, Ulcer 5 (10%) 2 (4%) 1 (2%) Stomach, Glandular (50) (50) (50) (50) (50) Inflammation, Chronic Active 1 (2%) 2 (4%) 2 (4%) 1 (2%) Mineralization 1 (2%) 1 (2%) Epithelium, Erosion 4 (8%) 2 (4%) 1 (2%) Epithelium, Hyperplasia 1 (2%) Epithelium, Necrosis 1 (2%) Epithelium, Ulcer 1 (2%) 1 (2%) 1 (2%) Glands, Ectasia 34 (68%) 34 (68%) 37 (74%) 27 (54%) 39 (78%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (50) (50) (50) Aorta, Mineralization 1 (2%) 1 (2%) 1 (2%) Media, Mineralization 1 (2%) Heart (50) (50) (50) (50) (50) Cardiomyopathy 44 (88%) 46 (92%) 46 (92%) 45 (90%) 50 (100%) Inflammation, Chronic Active 1 (2%) Mineralization 1 (2%) 2 (4%) 1 (2%) Atrium, Thrombosis 1 (2%) 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (50) (50) Accessory Adrenal Cortical Nodule 1 (2%) 2 (4%) 1 (2%) 2 (4%) Angiectasis 1 (2%) Atypia Cellular 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 2 (4%) 5 (10%) 2 (4%) 7 (14%) Hyperplasia 12 (24%) 9 (18%) 16 (32%) 14 (28%) 13 (26%) Hypertrophy 2 (4%) 3 (6%) 2 (4%) 1 (2%) 2 (4%) Mineralization 1 (2%) Necrosis 2 (4%) 3 (6%) 1 (2%) Vacuolization Cytoplasmic 30 (60%) 27 (54%) 30 (60%) 33 (66%) 24 (48%) Adrenal Medulla (50) (50) (50) (50) (50) Hyperplasia 8 (16%) 9 (18%) 14 (28%) 8 (16%) 5 (10%) Thrombosis 1 (2%) Islets, Pancreatic (50) (50) (50) (50) (50) Hyperplasia 1 (2%) Pituitary Gland (50) (50) (50) (50) (50) Pars Distalis, Angiectasis 1 (2%) 1 (2%) Pars Distalis, Cyst 2 (4%) 4 (8%) 6 (12%) 3 (6%) 4 (8%) Pars Distalis, Hemorrhage 1 (2%) Pars Distalis, Hyperplasia 16 (32%) 13 (26%) 16 (32%) 18 (36%) 21 (42%) Pars Distalis, Inflammation, Suppurative 1 (2%) Pars Distalis, Mineralization 1 (2%) Pars Intermedia, Angiectasis 1 (2%) Pars Intermedia, Cyst 2 (4%) 2 (4%) 2 (4%) Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (50) (50) (50) (50) (50) Ultimobranchial Cyst 3 (6%) 1 (2%) 2 (4%) 2 (4%) C-Cell, Hyperplasia 17 (34%) 22 (44%) 20 (40%) 15 (30%) 23 (46%) Follicle, Cyst 2 (4%) 2 (4%) 2 (4%) 2 (4%) 3 (6%) Follicular Cell, Hyperplasia 3 (6%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (49) (50) (50) Granuloma Sperm 3 (6%) 1 (2%) 6 (12%) 4 (8%) 5 (10%) Inflammation, Chronic Active 1 (2%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Preputial Gland (50) (50) (49) (50) (50) Hyperplasia 7 (14%) 2 (4%) 2 (4%) 3 (6%) Inflammation, Chronic, Diffuse, Suppurative 1 (2%) Inflammation, Chronic Active 49 (98%) 43 (86%) 47 (96%) 43 (86%) 49 (98%) Mineralization 2 (4%) 1 (2%) Duct, Ectasia 5 (10%) 7 (14%) 7 (14%) 6 (12%) 9 (18%) Prostate, NOS (50) (50) (49) (49) (50) Cyst 1 (2%) 3 (6%) 1 (2%) 1 (2%) 1 (2%) Degeneration 1 (2%) Inflammation, Chronic Active 21 (42%) 23 (46%) 20 (41%) 20 (41%) 15 (30%) Mineralization 1 (2%) 1 (2%) 1 (2%) 1 (2%) Epithelium, Hyperplasia 2 (4%) 4 (8%) 1 (2%) 8 (16%) 6 (12%) Seminal Vesicle (50) (50) (50) (49) (50) Inflammation, Chronic Active 1 (2%) 1 (2%) Testes (50) (50) (49) (50) (50) Atrophy 1 (2%) Cyst 1 (2%) Mineralization 42 (84%) 38 (76%) 44 (90%) 36 (72%) 41 (82%) Germinal Epithelium, Atrophy 4 (8%) 1 (2%) 3 (6%) 2 (4%) Interstitial Cell, Hyperplasia 10 (20%) 8 (16%) 4 (8%) 7 (14%) 3 (6%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (50) (50) Hyperplasia 29 (58%) 33 (66%) 21 (42%) 26 (52%) 22 (44%) Myeloid Cell, Hyperplasia 1 (2%) Lymph Node (24) (20) (28) (28) (20) Ectasia 2 (8%) 1 (4%) Hyperplasia, Lymphoid 1 (4%) Bronchial, Ectasia 1 (4%) Bronchial, Hyperplasia, Lymphoid 1 (4%) Deep Cervical, Ectasia 3 (13%) 4 (14%) 4 (14%) 2 (10%) Deep Cervical, Hyperplasia, Lymphoid 3 (13%) 1 (5%) 4 (14%) 4 (14%) 3 (15%) Mediastinal, Ectasia 6 (25%) 10 (50%) 11 (39%) 11 (39%) 7 (35%) Mediastinal, Hyperplasia, Lymphoid 7 (29%) 10 (50%) 10 (36%) 12 (43%) 12 (60%) Mediastinal, Pigmentation 1 (4%) Pancreatic, Ectasia 1 (4%) Lymph Node, Mandibular (2) (4) Ectasia 2 (100%) 1 (25%) Lymph Node, Mesenteric (50) (50) (50) (49) (50) Ectasia 2 (4%) 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Spleen (50) (50) (50) (50) (50) Congestion 2 (4%) Fibrosis 1 (2%) 3 (6%) Hematopoietic Cell Proliferation 2 (4%) 5 (10%) 10 (20%) 4 (8%) 6 (12%) Hyperplasia, Lymphoid 3 (6%) 2 (4%) 2 (4%) 1 (2%) 5 (10%) Infarct 1 (2%) 1 (2%) 1 (2%) Necrosis 1 (2%) Pigmentation 1 (2%) Lymphoid Follicle, Depletion Cellular 1 (2%) Thymus (43) (44) (45) (46) (43) Ectopic Parathyroid Gland 2 (5%) 1 (2%) 2 (4%) 2 (5%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (50) (50) (50) Cyst 1 (2%) Hyperplasia, Cystic 45 (90%) 47 (94%) 41 (82%) 45 (90%) 47 (94%) Inflammation, Chronic Active 1 (2%) Skin (50) (50) (50) (50) (50) Hyperkeratosis 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Inflammation, Granulomatous 1 (2%) Dermis, Fibrosis 1 (2%) Epidermis, Hyperplasia 1 (2%) 1 (2%) Hair Follicle, Sebaceous Gland, Atrophy 1 (2%) Subcutaneous Tissue, Mineralization 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (50) (50) Osteopetrosis 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (50) (50) Compression 3 (6%) 2 (4%) 2 (4%) 3 (6%) 1 (2%) Hemorrhage 6 (12%) 1 (2%) 4 (8%) 2 (4%) 1 (2%) Hydrocephalus 4 (8%) 3 (6%) 3 (6%) 5 (10%) 2 (4%) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM - CONT Mineralization 1 (2%) Necrosis 3 (6%) Pigmentation 1 (2%) Thrombosis 1 (2%) Spinal Cord (1) (1) Hemorrhage 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) (50) Fibrosis 2 (4%) Hemorrhage 1 (2%) 1 (2%) Inflammation, Chronic Active 26 (52%) 32 (64%) 31 (62%) 27 (54%) 36 (72%) Metaplasia, Osseous 1 (2%) Mineralization 45 (90%) 46 (92%) 47 (94%) 48 (96%) 49 (98%) Necrosis 1 (2%) Pigmentation 30 (60%) 35 (70%) 32 (64%) 23 (46%) 35 (70%) Thrombosis 1 (2%) Alveolar Epithelium, Hyperplasia 9 (18%) 10 (20%) 10 (20%) 9 (18%) 11 (22%) Alveolar Epithelium, Metaplasia, Focal, Squamous 1 (2%) Alveolus, Infiltration Cellular, Histiocyte 31 (62%) 36 (72%) 32 (64%) 24 (48%) 35 (70%) Nose (50) (50) (50) (50) (50) Foreign Body 2 (4%) 1 (2%) 4 (8%) 3 (6%) Inflammation, Chronic Active 2 (4%) 4 (8%) 2 (4%) 3 (6%) 4 (8%) Keratin Cyst 1 (2%) Polyp Inflammatory 1 (2%) Thrombosis 1 (2%) 2 (4%) 3 (6%) 6 (12%) 2 (4%) Nasolacrimal Duct, Inflammation, Suppurative 12 (24%) 6 (12%) 4 (8%) 5 (10%) 9 (18%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (2) (1) Cornea, Inflammation, Chronic Active 1 (50%) Cornea, Inflammation, Suppurative 1 (50%) Lens, Cataract 1 (50%) 1 (100%) 1 (50%) 1 (100%) Lens, Degeneration 1 (50%) Retina, Degeneration 2 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 56111-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC TRANS-CINNAMALDEHYDE Date: 09/26/01 Route: DOSED FEED Time: 15:19:28 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD VEHICLE .312% .625% 1.25% CONTROL CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (50) (50) Accumulation, Hyaline Droplet 1 (2%) 1 (2%) Atrophy 1 (2%) Cyst 1 (2%) 1 (2%) Hydronephrosis 1 (2%) Infarct 1 (2%) 2 (4%) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 1 (2%) Metaplasia, Osseous 1 (2%) Mineralization 38 (76%) 31 (62%) 30 (60%) 32 (64%) 38 (76%) Necrosis 1 (2%) 1 (2%) Nephropathy 47 (94%) 47 (94%) 49 (98%) 44 (88%) 45 (90%) Cortex, Medulla, Fibrosis 1 (2%) Cortex, Medulla, Pigmentation 1 (2%) Cortex, Medulla, Pelvis, Cyst 1 (2%) Medulla, Necrosis 1 (2%) Medulla, Renal Tubule, Dilatation 1 (2%) Urinary Bladder (50) (50) (49) (49) (50) Hemorrhage 1 (2%) 1 (2%) Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------