TDMS Study 05103-05 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL NTP Experiment-Test: 05103-05 Report: PEIRPT03 Study Type: CHRONIC Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 Facility: Southern Research Institute Chemical CAS #: 3296-90-0 Lock Date: 02/18/92 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: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 9 7 8 Early Deaths Moribund Sacrifice 14 22 27 41 Natural Death 2 3 6 Survivors Terminal Sacrifice 36 27 23 5 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (60) (60) (60) (60) Epithelium, Hyperplasia, Focal 1 (2%) Intestine Large, Colon (60) (60) (60) (60) Intussusception 1 (2%) Parasite Metazoan 2 (3%) 1 (2%) 1 (2%) 1 (2%) Intestine Large, Rectum (59) (60) (60) (60) Parasite Metazoan 2 (3%) 4 (7%) 2 (3%) Liver (60) (60) (60) (60) Angiectasis 2 (3%) 1 (2%) 2 (3%) Autolysis 1 (2%) Basophilic Focus 1 (2%) Congestion, Focal 1 (2%) Developmental Malformation 1 (2%) Eosinophilic Focus 1 (2%) Fatty Change 9 (15%) 12 (20%) 11 (18%) 8 (13%) Focal Cellular Change 42 (70%) 48 (80%) 43 (72%) 42 (70%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 3 (5%) Hemorrhage, Focal 1 (2%) Hepatodiaphragmatic Nodule 6 (10%) 5 (8%) 3 (5%) 9 (15%) Hepatodiaphragmatic Nodule, Multiple 1 (2%) 1 (2%) Hyperplasia, Histiocytic 1 (2%) Hyperplasia, Histiocytic, Lymphoid 1 (2%) Infiltration Cellular, Mixed Cell 4 (7%) 1 (2%) 6 (10%) 6 (10%) Inflammation, Focal 20 (33%) 19 (32%) 19 (32%) 19 (32%) Necrosis, Focal 1 (2%) 2 (3%) 7 (12%) Bile Duct, Hyperplasia 26 (43%) 24 (40%) 21 (35%) 19 (32%) Biliary Tract, Cyst 1 (2%) Centrilobular, Atrophy 11 (18%) 10 (17%) 10 (17%) 15 (25%) Centrilobular, Congestion 1 (2%) Centrilobular, Degeneration 1 (2%) Hepatocyte, Hyperplasia, Multifocal 8 (13%) 10 (17%) 7 (12%) 7 (12%) Mesentery (6) (12) (9) (6) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Accessory Spleen 1 (17%) Inflammation, Chronic 2 (33%) Fat, Necrosis 2 (33%) 9 (75%) 7 (78%) 3 (50%) Pancreas (60) (60) (60) (60) Accessory Spleen 1 (2%) 1 (2%) 1 (2%) Atrophy, Focal 24 (40%) 17 (28%) 22 (37%) 16 (27%) Fibrosis, Focal 1 (2%) Duct, Dilatation 1 (2%) Pharynx (1) (1) (1) (2) Palate, Epithelium, Hyperplasia, Focal 1 (50%) Stomach, Forestomach (60) (60) (60) (60) Edema 1 (2%) 1 (2%) Erosion 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) Pigmentation 1 (2%) Ulcer 1 (2%) 1 (2%) Ulcer, Multiple 1 (2%) Mucosa, Hyperplasia 2 (3%) 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (60) (60) (60) (60) Edema 1 (2%) 1 (2%) Erosion 1 (2%) 1 (2%) 1 (2%) 1 (2%) Pigmentation, Focal 1 (2%) Tongue (1) (3) (6) (6) Inflammation, Chronic, Focal 1 (17%) Epithelium, Hyperplasia, Focal 1 (33%) 1 (17%) 1 (17%) Tooth (2) Developmental Malformation 1 (50%) Incisor, Dysplasia 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (59) (60) (60) (60) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Accessory Adrenal Cortical Nodule 5 (8%) 4 (7%) 4 (7%) 3 (5%) Angiectasis 1 (2%) 1 (2%) 3 (5%) 1 (2%) Congestion 3 (5%) 2 (3%) Focal Cellular Change 11 (18%) 16 (27%) 8 (13%) 11 (18%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia, Histiocytic 2 (3%) Hyperplasia, Lymphoid 2 (3%) Vacuolization Cytoplasmic 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Adrenal Medulla (60) (60) (60) (60) Hyperplasia 2 (3%) 1 (2%) 4 (7%) 2 (3%) Parathyroid Gland (57) (59) (59) (60) Cyst 1 (2%) Hyperplasia 2 (3%) Pituitary Gland (58) (60) (59) (59) Angiectasis 18 (31%) 10 (17%) 9 (15%) 9 (15%) Cyst 7 (12%) 12 (20%) 12 (20%) 12 (20%) Hemorrhage 1 (2%) Pars Distalis, Angiectasis 1 (2%) 1 (2%) 1 (2%) Pars Distalis, Cyst 1 (2%) Pars Distalis, Focal Cellular Change 8 (14%) 5 (8%) 7 (12%) 2 (3%) Pars Distalis, Hyperplasia 1 (2%) Pars Distalis, Hyperplasia, Focal 9 (16%) 4 (7%) 1 (2%) 6 (10%) Pars Distalis, Pigmentation 1 (2%) Thyroid Gland (60) (60) (60) (60) Ultimobranchial Cyst 1 (2%) 1 (2%) 4 (7%) C-Cell, Hyperplasia 8 (13%) 14 (23%) 18 (30%) 14 (23%) Follicle, Dilatation 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (58) (58) (56) (60) Degeneration, Cystic 48 (83%) 50 (86%) 46 (82%) 56 (93%) Dilatation 1 (2%) Hyperplasia 4 (7%) 4 (7%) 4 (7%) 1 (2%) Inflammation, Chronic 2 (3%) 2 (3%) 2 (4%) 1 (2%) Ovary (60) (60) (60) (60) Angiectasis 1 (2%) Cyst 7 (12%) 4 (7%) 5 (8%) 7 (12%) Bilateral, Cyst 1 (2%) Corpus Luteum, Hyperplasia, Lymphoid 2 (3%) 3 (5%) 1 (2%) Corpus Luteum, Thecal Cell, Hyperplasia 2 (3%) 3 (5%) 1 (2%) Uterus (60) (60) (60) (60) Hydrometra 2 (3%) 2 (3%) 4 (7%) Inflammation, Suppurative 1 (2%) 1 (2%) 1 (2%) Cervix, Hyperplasia 1 (2%) Endometrium, Cyst 1 (2%) 2 (3%) 4 (7%) 2 (3%) Endometrium, Hyperplasia, Cystic 4 (7%) 2 (3%) 2 (3%) 7 (12%) Endometrium, Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Hypercellularity 5 (8%) 4 (7%) 11 (18%) 10 (17%) Hyperplasia, Focal, Histiocytic 1 (2%) Metaplasia, Osseous 1 (2%) Myelofibrosis 1 (2%) 1 (2%) Lymph Node (16) (11) (15) (19) Axillary, Hyperplasia 1 (5%) Deep Cervical, Hyperplasia 1 (7%) Iliac, Inflammation, Suppurative 1 (5%) Inguinal, Hyperplasia 1 (6%) 1 (5%) Mediastinal, Hemorrhage 6 (38%) 3 (27%) 1 (7%) 2 (11%) Mediastinal, Hyperplasia 1 (7%) Mediastinal, Pigmentation 1 (9%) 1 (5%) Pancreatic, Hemorrhage 1 (7%) Renal, Hyperplasia 1 (5%) Renal, Pigmentation 1 (5%) Lymph Node, Mandibular (59) (57) (60) (58) Hemorrhage 1 (2%) 1 (2%) Hyperplasia 1 (2%) 1 (2%) Lymph Node, Mesenteric (60) (60) (60) (60) Hemorrhage 2 (3%) 2 (3%) 2 (3%) 2 (3%) Hyperplasia 1 (2%) Spleen (60) (60) (60) (60) Angiectasis 1 (2%) Congestion 2 (3%) Fibrosis, Focal 1 (2%) 4 (7%) 5 (8%) Hematopoietic Cell Proliferation 1 (2%) 2 (3%) 7 (12%) 10 (17%) Necrosis, Focal 1 (2%) Thymus (59) (59) (58) (60) Congestion 1 (2%) Cyst 2 (3%) 2 (3%) Hemorrhage 2 (3%) Hyperplasia, Lymphoid 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (60) (60) (60) Dilatation 44 (73%) 45 (75%) 37 (62%) 34 (57%) Hyperplasia 7 (12%) 12 (20%) 8 (13%) 10 (17%) Inflammation, Chronic 1 (2%) Skin (60) (60) (60) (60) Alopecia 1 (2%) Hyperkeratosis, Focal 1 (2%) Epidermis, Hyperplasia, Focal 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Subcutaneous Tissue, Inflammation, Chronic, Focal 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Hyperostosis 10 (17%) 10 (17%) 10 (17%) 4 (7%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (59) (60) (60) (60) Compression 9 (15%) 10 (17%) 9 (15%) 4 (7%) Hemorrhage 1 (2%) 2 (3%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Congestion 1 (2%) 1 (2%) 1 (2%) Fibrosis, Focal 1 (2%) Hemorrhage, Diffuse 1 (2%) Hyperplasia, Focal, Macrophage 1 (2%) Inflammation, Chronic, Focal 1 (2%) 2 (3%) 1 (2%) Alveolar Epithelium, Hyperplasia 2 (3%) 4 (7%) 4 (7%) Pleura, Inflammation, Chronic, Focal 1 (2%) Nose (59) (60) (60) (60) Fungus 1 (2%) 3 (5%) 1 (2%) Inflammation, Suppurative 1 (2%) 2 (3%) 4 (7%) 2 (3%) Mucosa, Hyperplasia, Focal 1 (2%) Nasolacrimal Duct, Cyst 1 (2%) 1 (2%) Nasolacrimal Duct, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) (1) (3) Atrophy 2 (67%) 1 (33%) Cataract 3 (100%) 1 (100%) 1 (33%) Fibrosis 1 (33%) Hemorrhage 1 (33%) Inflammation, Chronic 1 (33%) Necrosis, Focal 1 (33%) Synechia 1 (33%) Retina, Degeneration 2 (67%) 1 (100%) 1 (33%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE UNTREATD 0.25% 0.50% 1.00% CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Atrophy, Focal 2 (3%) 1 (2%) 7 (12%) Cyst 1 (2%) 1 (2%) Inflammation, Chronic, Suppurative 1 (2%) Nephropathy 56 (93%) 57 (95%) 56 (93%) 57 (95%) Papilla, Degeneration 1 (2%) 3 (5%) 17 (28%) Papilla, Epithelium, Hyperplasia 1 (2%) 1 (2%) 7 (12%) Pelvis, Dilatation 1 (2%) Pelvis, Transitional Epithelium, Hyperplasia 1 (2%) Renal Tubule, Epithelium, Hyperplasia, Focal 1 (2%) Urinary Bladder (60) (60) (60) (60) Dilatation 1 (2%) Inflammation, Chronic 1 (2%) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.25% 0.50% 1.00% 2.00% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 60 60 60 70 Scheduled Sacrifice 19 7 9 5 10 Early Deaths Moribund Sacrifice 24 30 36 43 55 Natural Death 1 3 2 11 5 Survivors Terminal Sacrifice 26 20 13 1 Animals Examined Microscopically 70 60 60 60 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (70) (60) (60) (60) (70) Epithelium, Hyperplasia, Focal 1 (2%) Intestine Large, Colon (70) (59) (60) (59) (69) Parasite Metazoan 2 (3%) 3 (5%) 2 (3%) Thrombosis 1 (2%) Intestine Large, Rectum (70) (59) (59) (58) (69) Parasite Metazoan 2 (3%) 4 (7%) 5 (8%) 8 (14%) 2 (3%) Intestine Large, Cecum (70) (59) (60) (59) (69) Inflammation, Chronic 1 (1%) Parasite Metazoan 1 (2%) 1 (1%) Ulcer 1 (1%) Intestine Small, Jejunum (70) (59) (60) (58) (69) Diverticulum 2 (3%) Inflammation, Chronic, Focal 1 (1%) Metaplasia, Focal, Osseous 1 (1%) Mucosa, Hyperplasia 1 (2%) Mucosa, Hyperplasia, Cystic 1 (1%) Intestine Small, Ileum (70) (59) (60) (58) (69) Inflammation, Chronic, Focal 1 (1%) 2 (3%) Ulcer 1 (1%) Liver (70) (60) (60) (60) (70) Angiectasis 1 (1%) 2 (3%) 1 (2%) 3 (5%) 3 (4%) Basophilic Focus 32 (46%) 16 (27%) 16 (27%) 10 (17%) 12 (17%) Clear Cell Focus 3 (4%) 4 (7%) 1 (2%) 1 (2%) Congestion, Focal 1 (2%) 1 (1%) Cyst 2 (3%) Degeneration, Cystic 9 (13%) 6 (10%) 11 (18%) 5 (8%) 7 (10%) Developmental Malformation 1 (1%) Eosinophilic Focus 3 (4%) 6 (10%) 2 (3%) 2 (3%) 5 (7%) Fatty Change 27 (39%) 25 (42%) 16 (27%) 15 (25%) 19 (27%) Fibrosis, Focal 2 (3%) Focal Cellular Change 1 (2%) 2 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.25% 0.50% 1.00% 2.00% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hematopoietic Cell Proliferation 1 (1%) 1 (2%) 1 (2%) 3 (5%) 4 (6%) Hepatodiaphragmatic Nodule 5 (7%) 2 (3%) 4 (7%) 4 (7%) 5 (7%) Hepatodiaphragmatic Nodule, Multiple 1 (1%) 1 (2%) 1 (1%) Hyperplasia, Focal, Histiocytic, Lymphoid 1 (1%) Infarct 1 (2%) Infiltration Cellular, Mixed Cell 10 (14%) 5 (8%) 7 (12%) 8 (13%) 13 (19%) Inflammation, Focal 10 (14%) 8 (13%) 6 (10%) 4 (7%) 10 (14%) Mixed Cell Focus 1 (1%) 1 (2%) 1 (2%) 1 (2%) 1 (1%) Necrosis, Focal 7 (10%) 1 (2%) 2 (3%) 4 (7%) 2 (3%) Pigmentation 1 (2%) Thrombosis 1 (1%) 1 (2%) 1 (2%) Bile Duct, Dilatation, Focal 1 (2%) 1 (2%) Bile Duct, Hyperplasia 55 (79%) 50 (83%) 51 (85%) 43 (72%) 44 (63%) Biliary Tract, Cyst 1 (1%) Centrilobular, Atrophy 20 (29%) 23 (38%) 31 (52%) 26 (43%) 28 (40%) Centrilobular, Congestion 1 (2%) 1 (1%) Centrilobular, Hemorrhage 1 (1%) Centrilobular, Necrosis 1 (2%) 1 (2%) 4 (7%) 1 (1%) Hepatocyte, Hyperplasia, Multifocal 3 (4%) 9 (15%) 10 (17%) 8 (13%) 4 (6%) Mesentery (16) (20) (21) (23) (30) Accessory Spleen 1 (5%) Inflammation, Chronic 1 (6%) 1 (5%) 1 (5%) 2 (9%) 2 (7%) Fat, Necrosis 9 (56%) 9 (45%) 6 (29%) 5 (22%) 7 (23%) Pancreas (70) (60) (60) (58) (69) Accessory Spleen 1 (1%) Atrophy, Diffuse 1 (1%) Atrophy, Focal 33 (47%) 23 (38%) 27 (45%) 26 (45%) 22 (32%) Autolysis 1 (2%) Hyperplasia, Focal 1 (1%) 1 (2%) 1 (2%) Acinar Cell, Focal Cellular Change 1 (1%) Acinar Cell, Hyperplasia, Focal 3 (4%) 9 (15%) 12 (20%) 14 (24%) 27 (39%) Duct, Dilatation 1 (1%) 1 (2%) 2 (3%) 2 (3%) Pharynx (1) (3) (4) (5) (10) Palate, Epithelium, Hyperplasia, Focal 1 (100%) 1 (33%) 1 (25%) 3 (60%) 2 (20%) Salivary Glands (70) (59) (58) (60) (70) Cyst 1 (1%) Inflammation, Chronic 1 (2%) Stomach, Forestomach (70) (60) (60) (60) (69) Edema 1 (1%) 1 (2%) 1 (2%) Erosion 3 (5%) 1 (1%) Hyperplasia 1 (2%) Inflammation, Chronic 3 (4%) 9 (15%) 4 (7%) 3 (5%) 3 (4%) Pigmentation 1 (2%) Ulcer 1 (1%) 5 (8%) 4 (7%) 2 (3%) 2 (3%) Mucosa, Cyst 1 (2%) Mucosa, Hyperplasia 4 (6%) 12 (20%) 6 (10%) 6 (10%) 6 (9%) Stomach, Glandular (70) (60) (60) (58) (70) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.25% 0.50% 1.00% 2.00% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Edema 1 (1%) 1 (2%) Erosion 1 (1%) 1 (2%) 4 (7%) 4 (6%) Inflammation, Chronic 2 (3%) 2 (3%) Pigmentation, Focal 1 (1%) 1 (2%) 2 (3%) Mucosa, Hyperplasia 1 (1%) 2 (3%) Tongue (2) (5) (13) (9) Epithelium, Hyperplasia, Focal 4 (31%) 3 (33%) Tooth (1) (1) (2) Incisor, Dysplasia 1 (100%) 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (3) (1) (2) (2) Mesenteric Artery, Inflammation, Chronic 2 (100%) Heart (69) (60) (60) (60) (70) Inflammation, Chronic, Focal 1 (2%) Mineralization, Focal 1 (2%) Thrombosis 1 (1%) 1 (2%) 2 (3%) 2 (3%) 2 (3%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (70) (60) (60) (59) (70) Accessory Adrenal Cortical Nodule 7 (10%) 4 (7%) 4 (7%) 4 (7%) 11 (16%) Angiectasis 1 (2%) 1 (1%) Atrophy 1 (2%) Congestion 3 (4%) 1 (2%) 2 (3%) 1 (1%) Focal Cellular Change 7 (10%) 6 (10%) 6 (10%) 14 (24%) 6 (9%) Hematopoietic Cell Proliferation 1 (2%) 1 (1%) Hemorrhage 1 (2%) Hyperplasia 1 (2%) Necrosis, Focal 2 (3%) 1 (1%) Vacuolization Cytoplasmic 1 (2%) 1 (2%) 1 (1%) Adrenal Medulla (70) (60) (60) (59) (70) Angiectasis 1 (1%) Hyperplasia 10 (14%) 15 (25%) 13 (22%) 5 (8%) 9 (13%) Islets, Pancreatic (70) (60) (60) (60) (69) Hyperplasia 1 (1%) 1 (1%) Parathyroid Gland (68) (57) (58) (58) (68) Hyperplasia 4 (6%) 1 (2%) 1 (2%) 1 (1%) Pituitary Gland (69) (58) (59) (58) (67) Angiectasis 2 (3%) 2 (3%) 3 (5%) Cyst 3 (4%) 2 (3%) 1 (2%) 2 (3%) 6 (9%) Hemorrhage 1 (2%) Pars Distalis, Focal Cellular Change 7 (10%) 3 (5%) 4 (7%) 5 (9%) 6 (9%) Pars Distalis, Hyperplasia, Focal 5 (7%) 6 (10%) 1 (2%) 2 (3%) 5 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.25% 0.50% 1.00% 2.00% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Thyroid Gland (70) (60) (60) (60) (69) Ultimobranchial Cyst 3 (4%) 1 (2%) 3 (5%) C-Cell, Hyperplasia 8 (11%) 11 (18%) 5 (8%) 5 (8%) 15 (22%) Follicle, Dilatation 1 (2%) 3 (5%) 9 (13%) Follicular Cell, Hyperplasia 3 (4%) 2 (3%) 5 (8%) 6 (9%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (2) (3) (6) (8) Scrotal, Inflammation, Chronic 1 (17%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (1) (2) (3) Hyperplasia 1 (100%) 2 (100%) 3 (100%) Epididymis (70) (60) (60) (59) (70) Granuloma Sperm 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Preputial Gland (70) (59) (60) (60) (70) Degeneration, Cystic 67 (96%) 59 (100%) 57 (95%) 60 (100%) 64 (91%) Hyperplasia 2 (3%) 3 (5%) 2 (3%) Inflammation, Chronic 5 (7%) 3 (5%) 3 (5%) 3 (5%) 8 (11%) Prostate (70) (60) (60) (60) (70) Inflammation, Suppurative 33 (47%) 41 (68%) 34 (57%) 40 (67%) 36 (51%) Epithelium, Hyperplasia, Focal 3 (4%) 3 (5%) 1 (2%) Seminal Vesicle (70) (60) (60) (60) (70) Dilatation 1 (2%) 1 (1%) Edema 1 (1%) Hyperplasia 1 (1%) 8 (13%) 9 (15%) 17 (28%) 33 (47%) Inflammation, Chronic 2 (3%) Testes (70) (60) (60) (60) (70) Mineralization, Focal 1 (2%) Germinal Epithelium, Degeneration 7 (10%) 7 (12%) 7 (12%) 6 (10%) 4 (6%) Interstitial Cell, Hyperplasia 2 (3%) 4 (7%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (70) (60) (60) (60) (70) Hypercellularity 7 (10%) 7 (12%) 6 (10%) 16 (27%) 18 (26%) Hyperplasia, Focal, Histiocytic 1 (1%) Metaplasia, Osseous 4 (7%) Myelofibrosis 2 (3%) 1 (2%) 3 (5%) 2 (3%) Necrosis, Focal 1 (1%) Lymph Node (25) (23) (36) (27) (31) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.25% 0.50% 1.00% 2.00% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Deep Cervical, Hyperplasia 1 (3%) Iliac, Hyperplasia 1 (4%) Inguinal, Hyperplasia 2 (8%) 1 (4%) Inguinal, Hyperplasia, Lymphoid 1 (4%) Mediastinal, Edema 2 (6%) Mediastinal, Hemorrhage 2 (8%) 3 (13%) 1 (3%) 3 (11%) 4 (13%) Mediastinal, Hyperplasia 1 (4%) 2 (7%) 2 (6%) Mediastinal, Hyperplasia, Lymphoid 1 (3%) 1 (3%) Mediastinal, Pigmentation 1 (4%) 3 (10%) Mediastinal, Thrombosis 1 (3%) Pancreatic, Edema 1 (4%) Pancreatic, Hemorrhage 1 (4%) 1 (4%) Pancreatic, Hyperplasia, Macrophage 1 (4%) Lymph Node, Mandibular (68) (59) (58) (60) (69) Congestion 1 (2%) 1 (2%) Edema 1 (1%) 1 (2%) 1 (2%) 1 (2%) 1 (1%) Hemorrhage 1 (1%) 1 (2%) Hyperplasia 4 (6%) 2 (3%) 2 (3%) 3 (5%) 10 (14%) Pigmentation 1 (2%) Lymph Node, Mesenteric (69) (60) (60) (60) (70) Edema 1 (2%) 4 (7%) 3 (4%) Hemorrhage 2 (3%) Hyperplasia 1 (1%) 1 (2%) 4 (7%) 2 (3%) Hyperplasia, Lymphoid 1 (1%) 1 (2%) Spleen (70) (60) (60) (59) (70) Autolysis 1 (2%) Congestion 1 (2%) Developmental Malformation 1 (1%) 2 (3%) 1 (2%) Fibrosis, Focal 16 (23%) 11 (18%) 22 (37%) 24 (41%) 28 (40%) Hematopoietic Cell Proliferation 1 (1%) 3 (5%) 3 (5%) 8 (14%) 17 (24%) Necrosis, Focal 1 (1%) 2 (3%) 1 (1%) Pigmentation 1 (2%) Thymus (67) (60) (58) (57) (67) Congestion 1 (2%) Cyst 1 (1%) Hemorrhage 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (66) (58) (57) (53) (60) Angiectasis 1 (2%) Dilatation 11 (17%) 9 (16%) 11 (19%) 4 (8%) 4 (7%) Hemorrhage 1 (2%) Hyperplasia 3 (5%) 2 (3%) 3 (5%) 1 (2%) 2 (3%) Inflammation, Chronic 1 (2%) Skin (70) (60) (60) (59) (69) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.25% 0.50% 1.00% 2.00% CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - CONT Cyst Epithelial Inclusion 1 (2%) 1 (2%) 2 (3%) Hemorrhage, Focal 1 (2%) Hyperkeratosis, Focal 1 (1%) 1 (2%) 3 (5%) 2 (3%) 2 (3%) Inflammation, Chronic, Focal 1 (2%) 1 (2%) 3 (5%) 3 (4%) Ulcer 1 (2%) Epidermis, Hyperplasia, Focal 1 (1%) 2 (3%) 2 (3%) 2 (3%) 3 (4%) Hair Follicle, Cyst 1 (1%) Prepuce, Inflammation, Chronic 1 (2%) Sebaceous Gland, Cyst 1 (2%) Sebaceous Gland, Hyperplasia, Focal 1 (2%) 1 (1%) Subcutaneous Tissue, Fibrosis 1 (1%) 1 (2%) 1 (1%) Subcutaneous Tissue, Inflammation, Chronic, Focal 1 (2%) 2 (3%) Subcutaneous Tissue, Fat, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (70) (60) (60) (60) (70) Hyperostosis 6 (9%) 7 (12%) 4 (7%) 5 (8%) 11 (16%) Adventitia, Calvarium, Proliferation Connective Tissue 1 (1%) Skeletal Muscle (3) (2) (4) (4) Hemorrhage, Focal 1 (25%) Inflammation, Chronic 1 (25%) Necrosis, Focal 1 (25%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (60) (60) (60) (70) Compression 3 (4%) 7 (12%) 2 (3%) 3 (5%) 3 (4%) Hemorrhage 3 (4%) 3 (5%) 2 (3%) 2 (3%) 1 (1%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (70) (60) (60) (60) (70) Congestion 1 (1%) 3 (5%) 2 (3%) Hemorrhage, Focal 1 (2%) 2 (3%) 1 (2%) 1 (1%) Hyperplasia, Diffuse, Histiocytic 1 (2%) Hyperplasia, Focal, Histiocytic 1 (2%) Inflammation, Chronic, Focal 2 (3%) 1 (2%) 1 (1%) Metaplasia, Osseous 1 (1%) 1 (1%) Alveolar Epithelium, Hyperplasia 3 (4%) 4 (7%) 5 (8%) 7 (12%) 14 (20%) Peribronchial, Infiltration Cellular, Lymphocyte 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.25% 0.50% 1.00% 2.00% CONTROL ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nose (70) (60) (60) (60) (70) Fungus 7 (10%) 3 (5%) 6 (10%) 5 (8%) 5 (7%) Inflammation, Suppurative 12 (17%) 8 (13%) 17 (28%) 11 (18%) 11 (16%) Mucosa, Angiectasis, Focal 1 (2%) Mucosa, Hyperkeratosis, Focal 1 (2%) Mucosa, Hyperplasia, Focal 2 (3%) Mucosa, Metaplasia, Focal, Squamous 2 (3%) Nasolacrimal Duct, Inflammation, Chronic Active 1 (1%) Respiratory Epithelium, Hyperplasia, Focal 1 (1%) Trachea (70) (60) (60) (60) (70) Glands, Dilatation 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (3) (1) Atrophy 1 (100%) 1 (33%) Cataract 1 (50%) 2 (67%) Fibrosis 1 (100%) Inflammation, Chronic 1 (50%) Synechia 1 (50%) 1 (33%) Cornea, Inflammation, Chronic 1 (33%) Retina, Degeneration 1 (100%) 1 (33%) Sclera, Mineralization, Focal 1 (100%) Zymbal's Gland (2) (1) (5) (5) (15) Dilatation 1 (20%) 1 (7%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (60) (60) (60) (69) Atrophy, Focal 6 (10%) Cyst 2 (3%) 1 (2%) 1 (1%) Hydronephrosis 1 (1%) Infarct 1 (1%) Inflammation, Chronic, Suppurative 1 (2%) 1 (2%) Nephropathy 70 (100%) 60 (100%) 60 (100%) 58 (97%) 61 (88%) Cortex, Medulla, Mineralization, Focal 1 (2%) Papilla, Degeneration 5 (8%) 32 (53%) 33 (55%) 24 (35%) Papilla, Mineralization, Focal 2 (3%) Papilla, Epithelium, Hyperplasia 11 (16%) 20 (33%) 26 (43%) 52 (87%) 21 (30%) Pelvis, Dilatation 1 (2%) 1 (2%) 1 (1%) Pelvis, Transitional Epithelium, Hyperplasia 4 (7%) 4 (6%) Renal Tubule, Epithelium, Hyperplasia, Focal 2 (3%) Urethra (1) (1) (1) (1) Bulbourethral Gland, Dilatation 1 (100%) 1 (100%) 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05103-05 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL Date: 05/19/95 Route: DOSED FEED Time: 19:49:13 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE UNTREATD 0.25% 0.50% 1.00% 2.00% CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Urinary Bladder (70) (60) (60) (60) (69) Dilatation 1 (2%) Hemorrhage 1 (1%) Inflammation, Chronic 1 (1%) 1 (2%) 2 (3%) Transitional Epithelium, Hyperplasia 1 (2%) 3 (5%) 20 (29%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------