TDMS Study 05103-04 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL NTP Experiment-Test: 05103-04 Report: PEIRPT03 Study Type: CHRONIC Date: 05/19/95 Route: DOSED FEED Time: 19:06:50 Facility: Southern Research Institute Chemical CAS #: 3296-90-0 Lock Date: 02/12/92 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: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 8 10 9 10 Early Deaths Moribund Sacrifice 9 14 14 29 Natural Death 6 6 11 10 Survivors Terminal Sacrifice 37 30 26 11 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (59) (59) (59) (58) Mucosa, Hyperplasia 1 (2%) Gallbladder (56) (57) (55) (55) Dilatation 2 (4%) 1 (2%) Intestine Large, Cecum (60) (60) (58) (60) Edema 3 (5%) 1 (2%) 4 (7%) 4 (7%) Intestine Small, Duodenum (59) (60) (56) (59) Ulcer 1 (2%) Intestine Small, Jejunum (57) (59) (58) (57) Peyer's Patch, Hyperplasia 1 (2%) Intestine Small, Ileum (59) (60) (56) (57) Amyloid Deposition 1 (2%) Liver (59) (60) (59) (59) Basophilic Focus 1 (2%) 4 (7%) 2 (3%) 2 (3%) Clear Cell Focus 1 (2%) Cyst 1 (2%) Degeneration, Fatty 1 (2%) 1 (2%) 3 (5%) Developmental Malformation 1 (2%) 1 (2%) Eosinophilic Focus 4 (7%) 2 (3%) 3 (5%) 6 (10%) Hematopoietic Cell Proliferation 9 (15%) 6 (10%) 4 (7%) 15 (25%) Hyperplasia, Lymphoid 3 (5%) 1 (2%) 1 (2%) 2 (3%) Inflammation, Subacute 7 (12%) 3 (5%) 2 (3%) 2 (3%) Mixed Cell Focus 1 (2%) 2 (3%) 3 (5%) 1 (2%) Centrilobular, Necrosis 1 (2%) 2 (3%) 2 (3%) Kupffer Cell, Hyperplasia 6 (10%) 4 (7%) 7 (12%) 12 (20%) Kupffer Cell, Pigmentation 2 (3%) 1 (2%) 1 (2%) Lobules, Necrosis 4 (7%) 7 (12%) 6 (10%) 6 (10%) Mesentery (4) (7) (8) (8) Inflammation, Chronic 2 (25%) Fat, Necrosis 4 (100%) 6 (86%) 4 (50%) 7 (88%) Pancreas (59) (60) (58) (58) Atrophy 1 (2%) 3 (5%) 3 (5%) 5 (9%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Cyst 1 (2%) 2 (3%) 3 (5%) 5 (9%) Focal Cellular Change 1 (2%) 4 (7%) Hyperplasia, Lymphoid 2 (3%) 2 (3%) Acinar Cell, Cytoplasmic Alteration 4 (7%) 3 (5%) 2 (3%) 2 (3%) Salivary Glands (60) (60) (60) (60) Hyperplasia, Lymphoid 4 (7%) 4 (7%) 6 (10%) 5 (8%) Stomach, Forestomach (59) (60) (60) (59) Diverticulum 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) Ulcer 5 (8%) 2 (3%) 7 (12%) 6 (10%) Mucosa, Hyperkeratosis 1 (2%) Mucosa, Hyperplasia 10 (17%) 5 (8%) 16 (27%) 9 (15%) Stomach, Glandular (59) (60) (58) (59) Ectopic Tissue 1 (2%) Edema 1 (2%) 1 (2%) 2 (3%) Erosion 1 (2%) 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Subacute 3 (5%) 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (2%) Ulcer 1 (2%) Mucosa, Hyperplasia 1 (2%) 1 (2%) 2 (3%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) Inflammation, Subacute 1 (100%) Heart (60) (60) (60) (60) Inflammation, Chronic 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (2%) Thrombosis 1 (2%) 1 (2%) 1 (2%) Myocardium, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (59) (60) (60) (59) Accessory Adrenal Cortical Nodule 5 (8%) 6 (10%) 6 (10%) 6 (10%) Angiectasis 1 (2%) Cyst 2 (3%) Degeneration, Fatty 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 3 (5%) 2 (3%) 2 (3%) 2 (3%) Hyperplasia, Focal 1 (2%) Hypertrophy, Focal 2 (3%) 1 (2%) 1 (2%) 1 (2%) Capsule, Hyperplasia 1 (2%) 1 (2%) Adrenal Medulla (59) (60) (60) (59) Atrophy 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hyperplasia 1 (2%) 1 (2%) 1 (2%) Islets, Pancreatic (59) (60) (58) (59) Hyperplasia 2 (3%) 2 (3%) 3 (5%) Parathyroid Gland (52) (54) (58) (56) Cyst 2 (4%) 4 (7%) 3 (5%) Ectopic Tissue 1 (2%) 1 (2%) Pituitary Gland (58) (58) (57) (56) Pars Distalis, Angiectasis 3 (5%) 2 (3%) 5 (9%) 1 (2%) Pars Distalis, Cyst 1 (2%) 1 (2%) 1 (2%) Pars Distalis, Hyperplasia, Focal 9 (16%) 4 (7%) 5 (9%) 8 (14%) Thyroid Gland (59) (60) (60) (59) Degeneration, Cystic 12 (20%) 7 (12%) 14 (23%) 14 (24%) Ectopic Thymus 1 (2%) Follicle, Cyst 3 (5%) 4 (7%) 2 (3%) 2 (3%) Follicular Cell, Hyperplasia 13 (22%) 15 (25%) 9 (15%) 3 (5%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (60) (58) (60) (60) Ectasia 9 (15%) 9 (16%) 10 (17%) 11 (18%) Inflammation, Chronic 2 (3%) 1 (2%) 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) Pigmentation 2 (3%) Ovary (59) (59) (60) (57) Angiectasis 9 (15%) 5 (8%) 18 (30%) 12 (21%) Cyst 11 (19%) 13 (22%) 11 (18%) 17 (30%) Inflammation, Suppurative 8 (14%) 2 (3%) 4 (7%) 6 (11%) Uterus (60) (60) (60) (60) Angiectasis 2 (3%) 6 (10%) 16 (27%) 17 (28%) Hydrometra 10 (17%) 6 (10%) 8 (13%) 5 (8%) Hyperplasia, Cystic 53 (88%) 51 (85%) 52 (87%) 55 (92%) Inflammation, Granulomatous 1 (2%) 1 (2%) Inflammation, Suppurative 11 (18%) 3 (5%) 6 (10%) 3 (5%) Metaplasia, Squamous 4 (7%) 3 (5%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Hypercellularity 13 (22%) 15 (25%) 15 (25%) 26 (43%) Myelofibrosis 7 (12%) 5 (8%) 6 (10%) 7 (12%) Necrosis 1 (2%) Lymph Node (9) (12) (6) (9) Bronchial, Hyperplasia, Lymphoid 1 (11%) Iliac, Hematopoietic Cell Proliferation 1 (11%) 1 (17%) 1 (11%) Iliac, Hyperplasia, Lymphoid 6 (67%) 1 (8%) 3 (33%) Inguinal, Hyperplasia, Lymphoid 1 (8%) Mediastinal, Hyperplasia, Lymphoid 2 (22%) 1 (17%) 3 (33%) Mediastinal, Inflammation, Suppurative 1 (11%) Pancreatic, Hematopoietic Cell Proliferation 1 (11%) Pancreatic, Hyperplasia, Lymphoid 1 (11%) Pancreatic, Necrosis 1 (8%) Renal, Hyperplasia, Lymphoid 6 (67%) 2 (17%) 5 (56%) Lymph Node, Mandibular (56) (56) (59) (56) Atrophy 1 (2%) Hematopoietic Cell Proliferation 1 (2%) 1 (2%) 2 (4%) Hemorrhage 1 (2%) 2 (4%) Hyperplasia, Lymphoid 5 (9%) 7 (13%) 8 (14%) 11 (20%) Pigmentation 6 (11%) 5 (9%) 7 (13%) Lymph Node, Mesenteric (57) (58) (55) (58) Angiectasis 1 (2%) 1 (2%) 2 (4%) Atrophy 1 (2%) Hematopoietic Cell Proliferation 2 (4%) 1 (2%) 1 (2%) 3 (5%) Hemorrhage 4 (7%) 4 (7%) 1 (2%) 4 (7%) Hyperplasia, Lymphoid 6 (11%) 4 (7%) 4 (7%) 9 (16%) Pigmentation 1 (2%) Spleen (59) (60) (59) (60) Hematopoietic Cell Proliferation 20 (34%) 25 (42%) 26 (44%) 41 (68%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) 2 (3%) 1 (2%) Pigmentation, Hemosiderin 3 (5%) 3 (5%) 2 (3%) 4 (7%) Lymphoid Follicle, Atrophy 1 (2%) Lymphoid Follicle, Hyperplasia 8 (14%) 3 (5%) 6 (10%) 5 (8%) Red Pulp, Atrophy 1 (2%) Thymus (54) (57) (55) (52) Atrophy 2 (4%) 3 (5%) 4 (7%) 4 (8%) Ectopic Parathyroid Gland 1 (2%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (59) (60) (59) (59) Hyperplasia, Cystic 1 (2%) 3 (5%) 1 (2%) 2 (3%) Hyperplasia, Lobular 1 (2%) 2 (3%) 1 (2%) Skin (59) (60) (60) (60) Acanthosis 1 (2%) Edema 1 (2%) 1 (2%) Inflammation, Subacute 1 (2%) 1 (2%) 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (60) Hyperostosis 2 (3%) 3 (5%) 3 (5%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Compression 4 (7%) 2 (3%) Hemorrhage 1 (2%) 1 (2%) Inflammation, Chronic 2 (3%) Necrosis 1 (2%) Peripheral Nerve (1) (1) (1) (1) Atrophy 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Congestion 1 (2%) 1 (2%) Foreign Body 1 (2%) 1 (2%) Hemorrhage 2 (3%) 2 (3%) 3 (5%) 3 (5%) Hyperplasia, Lymphoid 3 (5%) 5 (8%) 7 (12%) 1 (2%) Infiltration Cellular, Histiocyte 2 (3%) 5 (8%) 5 (8%) 5 (8%) Inflammation, Subacute 1 (2%) 1 (2%) 3 (5%) 2 (3%) Mineralization 1 (2%) Thrombosis 1 (2%) 3 (5%) 2 (3%) 1 (2%) Alveolar Epithelium, Hyperplasia 2 (3%) 3 (5%) 8 (13%) 15 (25%) Nose (60) (60) (60) (60) Exudate 3 (5%) 2 (3%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (3) (7) Cataract 2 (100%) 1 (33%) 2 (29%) Inflammation, Chronic 1 (50%) 5 (71%) Phthisis Bulbi 2 (67%) 1 (14%) Harderian Gland (22) (32) (31) (40) Hyperplasia 1 (5%) 1 (3%) 3 (10%) 1 (3%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (59) (60) (60) (59) Casts Protein 19 (32%) 22 (37%) 16 (27%) 8 (14%) Cyst 2 (3%) 2 (3%) 1 (2%) Glomerulosclerosis 1 (2%) 1 (2%) Hydronephrosis 1 (2%) Hyperplasia, Lymphoid 9 (15%) 11 (18%) 7 (12%) 4 (7%) Metaplasia, Osseous 1 (2%) 1 (2%) 2 (3%) 1 (2%) Mineralization 1 (2%) 2 (3%) 1 (2%) Renal Tubule, Atrophy 1 (2%) Renal Tubule, Cytoplasmic Alteration 1 (2%) 1 (2%) 2 (3%) Renal Tubule, Dilatation 3 (5%) 1 (2%) 2 (3%) 2 (3%) Renal Tubule, Necrosis 2 (3%) 1 (2%) Renal Tubule, Pigmentation 1 (2%) 1 (2%) 1 (2%) Renal Tubule, Regeneration 7 (12%) 11 (18%) 11 (18%) 7 (12%) Transitional Epithelium, Hyperplasia 1 (2%) Urinary Bladder (59) (60) (59) (60) Edema 1 (2%) 2 (3%) 1 (2%) Hyperplasia, Lymphoid 2 (3%) 3 (5%) 3 (5%) 3 (5%) Inflammation, Subacute 2 (3%) 1 (2%) Mucosa, Hyperplasia 1 (2%) 2 (3%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 60 60 60 Scheduled Sacrifice 10 9 10 10 Early Deaths Natural Death 5 3 4 5 Moribund Sacrifice 3 12 11 13 Accidently Killed 1 Survivors Terminal Sacrifice 42 36 35 30 Missing 1 Animals Examined Microscopically 60 60 60 59 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (58) (59) (59) (55) Edema 1 (2%) Intestine Large, Rectum (58) (59) (58) (58) Edema 1 (2%) Inflammation, Chronic 1 (2%) Intestine Large, Cecum (59) (58) (58) (58) Edema 3 (5%) 4 (7%) 1 (2%) 8 (14%) Parasite Metazoan 1 (2%) Intestine Small, Jejunum (59) (58) (59) (58) Peyer's Patch, Hyperplasia 1 (2%) Intestine Small, Ileum (58) (57) (57) (58) Amyloid Deposition 1 (2%) Hyperplasia, Lymphoid 1 (2%) Peyer's Patch, Hyperplasia 2 (3%) Liver (59) (60) (59) (59) Basophilic Focus 3 (5%) 3 (5%) 4 (7%) 3 (5%) Clear Cell Focus 6 (10%) 7 (12%) 3 (5%) 3 (5%) Congestion 1 (2%) Cyst 1 (2%) Developmental Malformation 1 (2%) Eosinophilic Focus 4 (7%) 4 (7%) 7 (12%) 3 (5%) Hematopoietic Cell Proliferation 1 (2%) 2 (3%) 4 (7%) Hemorrhage 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Subacute 3 (5%) 2 (3%) 6 (10%) 3 (5%) Mineralization 2 (3%) 2 (3%) Mixed Cell Focus 5 (8%) 2 (3%) 1 (2%) 2 (3%) Necrosis 1 (2%) 1 (2%) Thrombosis 1 (2%) Hepatocyte, Nuclear Alteration 1 (2%) 3 (5%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Vacuolization Cytoplasmic 1 (2%) Kupffer Cell, Hyperplasia 1 (2%) 2 (3%) 2 (3%) 5 (8%) Kupffer Cell, Pigmentation 1 (2%) 2 (3%) 2 (3%) Lobules, Necrosis 1 (2%) 4 (7%) 4 (7%) 3 (5%) Mesentery (3) (2) (1) (4) Fat, Necrosis 3 (100%) 1 (100%) 2 (50%) Pancreas (59) (60) (59) (59) Atrophy 1 (2%) 1 (2%) 1 (2%) 1 (2%) Cyst 1 (2%) Acinar Cell, Cytoplasmic Alteration 1 (2%) 1 (2%) 2 (3%) 1 (2%) Salivary Glands (59) (60) (59) (59) Hyperplasia, Lymphoid 2 (3%) 1 (2%) 3 (5%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Stomach, Forestomach (59) (60) (60) (58) Diverticulum 1 (2%) Ulcer 2 (3%) 1 (2%) 3 (5%) Mucosa, Hyperplasia 4 (7%) 1 (2%) 4 (7%) 4 (7%) Stomach, Glandular (59) (60) (59) (58) Ectopic Tissue 1 (2%) Edema 1 (2%) 1 (2%) Erosion 1 (2%) 1 (2%) Mineralization 1 (2%) Mucosa, Hyperplasia 2 (3%) 2 (3%) Tooth (13) (2) (4) (3) Dysplasia 13 (100%) 2 (100%) 4 (100%) 3 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (59) Inflammation, Chronic 1 (2%) Mineralization 1 (2%) 3 (5%) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (58) (60) (60) (59) Accessory Adrenal Cortical Nodule 3 (5%) 4 (7%) 3 (5%) 2 (3%) Cyst 1 (2%) Hyperplasia, Focal 4 (7%) 4 (7%) 7 (12%) 3 (5%) Hypertrophy, Focal 14 (24%) 20 (33%) 17 (28%) 10 (17%) Vacuolization Cytoplasmic 1 (2%) Capsule, Hyperplasia 5 (9%) 4 (7%) 5 (8%) 5 (8%) Adrenal Medulla (59) (59) (60) (59) Hyperplasia 1 (2%) 2 (3%) Islets, Pancreatic (59) (59) (59) (59) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Hemorrhage 1 (2%) Hyperplasia 17 (29%) 16 (27%) 12 (20%) 8 (14%) Parathyroid Gland (57) (56) (56) (58) Cyst 2 (4%) 2 (4%) 6 (11%) 1 (2%) Pituitary Gland (57) (54) (59) (54) Pars Distalis, Cyst 2 (4%) 3 (6%) 2 (3%) 3 (6%) Pars Distalis, Hyperplasia, Focal 1 (2%) Thyroid Gland (59) (60) (59) (59) Degeneration, Cystic 10 (17%) 9 (15%) 12 (20%) 6 (10%) Follicle, Cyst 2 (3%) 3 (5%) 1 (2%) Follicular Cell, Hyperplasia 6 (10%) 6 (10%) 4 (7%) 2 (3%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Cyst 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (2) (2) Dilatation 2 (100%) 2 (100%) Epididymis (59) (60) (60) (59) Atypia Cellular 1 (2%) Granuloma Sperm 1 (2%) Hypospermia 1 (2%) 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Spermatocele 1 (2%) 2 (3%) 2 (3%) Preputial Gland (58) (58) (59) (58) Angiectasis 1 (2%) 1 (2%) Atrophy 2 (3%) 1 (2%) Ectasia 28 (48%) 23 (40%) 30 (51%) 28 (48%) Hyperplasia 1 (2%) 1 (2%) Inflammation, Chronic 25 (43%) 19 (33%) 22 (37%) 14 (24%) Inflammation, Granulomatous 1 (2%) Inflammation, Suppurative 8 (14%) 13 (22%) 15 (25%) 11 (19%) Prostate (59) (60) (60) (57) Hemorrhage 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) Seminal Vesicle (59) (60) (60) (59) Dilatation 15 (25%) 10 (17%) 11 (18%) 8 (14%) Fibrosis 1 (2%) Hemorrhage 2 (3%) 1 (2%) Inflammation, Chronic 2 (3%) 1 (2%) Testes (59) (60) (60) (59) Granuloma Sperm 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Interstitial Cell, Hyperplasia 1 (2%) Seminiferous Tubule, Atrophy 3 (5%) 1 (2%) 2 (3%) 2 (3%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (59) (60) (60) (59) Hypercellularity 5 (8%) 12 (20%) 11 (18%) 13 (22%) Necrosis 1 (2%) 1 (2%) Lymph Node (3) (3) (5) (7) Bronchial, Hyperplasia, Lymphoid 1 (14%) Iliac, Hyperplasia, Lymphoid 1 (33%) Inguinal, Hematopoietic Cell Proliferation 1 (14%) Inguinal, Hyperplasia, Lymphoid 2 (67%) 2 (67%) 1 (20%) 3 (43%) Inguinal, Pigmentation 1 (33%) Mediastinal, Hematopoietic Cell Proliferation 1 (14%) Mediastinal, Hyperplasia, Lymphoid 1 (14%) Renal, Hemorrhage 1 (33%) Renal, Hyperplasia, Lymphoid 1 (33%) Lymph Node, Mandibular (56) (58) (59) (55) Atrophy 2 (3%) Hematopoietic Cell Proliferation 1 (2%) 2 (4%) Hyperplasia, Lymphoid 1 (2%) 3 (5%) 1 (2%) 5 (9%) Pigmentation 6 (11%) 3 (5%) 6 (10%) 3 (5%) Lymph Node, Mesenteric (58) (58) (59) (58) Angiectasis 2 (3%) 2 (3%) Atrophy 1 (2%) Hematopoietic Cell Proliferation 4 (7%) 3 (5%) 5 (9%) Hemorrhage 19 (33%) 15 (26%) 18 (31%) 22 (38%) Hyperplasia, Lymphoid 4 (7%) 12 (21%) 8 (14%) 4 (7%) Pigmentation 1 (2%) 1 (2%) 1 (2%) Spleen (59) (60) (59) (59) Hematopoietic Cell Proliferation 10 (17%) 22 (37%) 16 (27%) 19 (32%) Infiltration Cellular, Mast Cell 1 (2%) Lymphoid Follicle, Atrophy 1 (2%) 4 (7%) 1 (2%) Lymphoid Follicle, Hyperplasia 1 (2%) 1 (2%) 1 (2%) Red Pulp, Atrophy 2 (3%) 1 (2%) Thymus (53) (57) (50) (52) Atrophy 4 (7%) 4 (8%) Congestion 1 (2%) Hyperplasia, Lymphoid 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (60) (60) (60) (59) Acanthosis 1 (2%) 2 (3%) Cyst Epithelial Inclusion 1 (2%) Inflammation, Subacute 1 (2%) Inflammation, Suppurative 1 (2%) 1 (2%) Ulcer 1 (2%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (60) (60) (60) (59) Hyperostosis 2 (3%) 3 (5%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (59) Compression 1 (2%) Cyst 1 (2%) 1 (2%) 1 (2%) Hemorrhage 1 (2%) 1 (2%) Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (59) Congestion 1 (2%) Hemorrhage 1 (2%) 1 (2%) 3 (5%) 3 (5%) Hyperplasia, Lymphoid 3 (5%) 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 6 (10%) 8 (13%) 5 (8%) 10 (17%) Inflammation, Subacute 1 (2%) Thrombosis 1 (2%) 1 (2%) 2 (3%) Alveolar Epithelium, Hyperplasia 7 (12%) 7 (12%) 6 (10%) 11 (19%) Nose (59) (60) (60) (59) Exudate 1 (2%) 1 (2%) 1 (2%) 3 (5%) Foreign Body 1 (2%) Mucosa, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (4) (9) Cataract 1 (50%) 1 (25%) 2 (22%) Inflammation, Chronic 1 (50%) 3 (75%) 2 (22%) Phthisis Bulbi 1 (50%) Cornea, Hyperplasia 1 (25%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05103-04 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: 19:06:50 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE UNTREATD 0.0312% 0.0625% 0.125% CONTROL ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM - CONT Harderian Gland (26) (31) (33) (36) Hyperplasia 1 (3%) 2 (6%) 3 (8%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (59) (60) (60) (59) Casts Protein 7 (12%) 14 (23%) 10 (17%) 5 (8%) Cyst 13 (22%) 13 (22%) 10 (17%) 12 (20%) Hydronephrosis 1 (2%) 4 (7%) 2 (3%) 1 (2%) Hyperplasia, Lymphoid 3 (5%) 4 (7%) 5 (8%) 2 (3%) Inflammation, Suppurative 1 (2%) 1 (2%) Metaplasia, Osseous 1 (2%) 1 (2%) 2 (3%) Mineralization 41 (69%) 35 (58%) 41 (68%) 33 (56%) Papilla, Necrosis 1 (2%) Renal Tubule, Atrophy 1 (2%) 1 (2%) 2 (3%) Renal Tubule, Casts Protein 1 (2%) Renal Tubule, Dilatation 2 (3%) 1 (2%) 3 (5%) 1 (2%) Renal Tubule, Hyperplasia 2 (3%) Renal Tubule, Necrosis 1 (2%) 1 (2%) Renal Tubule, Pigmentation 1 (2%) Renal Tubule, Regeneration 50 (85%) 47 (78%) 53 (88%) 44 (75%) Transitional Epithelium, Hyperplasia 1 (2%) Urethra (1) Concretion 1 (100%) Inflammation, Subacute 1 (100%) Urinary Bladder (59) (60) (59) (59) Dilatation 2 (3%) Edema 1 (2%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Inflammation, Suppurative 1 (2%) Mucosa, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------