TDMS Study 96018-03 Pathology Tables
NTP Experiment-Test: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
FINAL #2/RATS
Facility: Southern Research Institute
Chemical CAS #: 75-27-4
Lock Date: 02/19/02
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: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/L 175 MG/L 350 MG/L 700 MG/L
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 50 50 50 50
Early Deaths
Moribund Sacrifice 16 19 14 15
Natural Death 5 2 7 9
Accidently Killed 1
Survivors
Terminal Sacrifice 28 27 29 26
Moribund Sacrifice 1 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (46) (49) (44) (43)
Edema 1 (2%)
Liver (50) (50) (50) (50)
Angiectasis, Focal 4 (8%) 4 (8%) 5 (10%) 2 (4%)
Basophilic Focus 33 (66%) 25 (50%) 24 (48%) 17 (34%)
Cholangiofibrosis 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Clear Cell Focus 28 (56%) 24 (48%) 19 (38%) 17 (34%)
Congestion 2 (4%) 1 (2%) 1 (2%) 4 (8%)
Degeneration, Cystic, Focal 31 (62%) 24 (48%) 23 (46%) 29 (58%)
Eosinophilic Focus 1 (2%) 4 (8%)
Fibrosis, Focal 1 (2%) 1 (2%) 1 (2%) 3 (6%)
Hemorrhage, Focal 1 (2%)
Hepatodiaphragmatic Nodule 5 (10%) 5 (10%) 12 (24%) 4 (8%)
Hyperplasia, Focal, Histiocytic 1 (2%)
Hyperplasia, Focal, Regenerative 1 (2%)
Infiltration Cellular, Mixed Cell 30 (60%) 31 (62%) 34 (68%) 34 (68%)
Inflammation, Chronic 23 (46%) 29 (58%) 33 (66%) 34 (68%)
Mixed Cell Focus 3 (6%) 10 (20%) 4 (8%)
Necrosis, Focal 2 (4%) 1 (2%)
Tension Lipidosis 1 (2%)
Bile Duct, Hyperplasia 45 (90%) 49 (98%) 49 (98%) 50 (100%)
Hepatocyte, Fatty Change 36 (72%) 34 (68%) 36 (72%) 40 (80%)
Hepatocyte, Hyperplasia, Regenerative 1 (2%)
Hepatocyte, Hypertrophy 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 11 (22%) 10 (20%) 19 (38%) 18 (36%)
Hepatocyte, Centrilobular, Necrosis 1 (2%) 1 (2%) 1 (2%) 4 (8%)
Serosa, Bile Duct, Inflammation, Chronic,
Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/L 175 MG/L 350 MG/L 700 MG/L
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mesentery (15) (13) (14) (15)
Hemorrhage, Focal 1 (7%)
Inflammation, Chronic 1 (7%) 1 (7%)
Fat, Necrosis, Focal 8 (53%) 4 (31%) 9 (64%) 7 (47%)
Pancreas (49) (50) (50) (49)
Cyst 1 (2%)
Hyperplasia, Focal, Histiocytic 1 (2%)
Acinus, Atrophy, Focal 31 (63%) 20 (40%) 23 (46%) 21 (43%)
Acinus, Hyperplasia, Focal 1 (2%)
Duct, Cyst 1 (2%)
Duct, Cyst, Focal, Multiple 16 (33%) 14 (28%) 17 (34%) 11 (22%)
Stomach, Forestomach (50) (50) (50) (50)
Edema 2 (4%) 2 (4%) 3 (6%) 4 (8%)
Erosion 1 (2%)
Inflammation, Chronic, Diffuse 1 (2%)
Inflammation, Diffuse 2 (4%)
Inflammation, Focal 1 (2%) 2 (4%) 2 (4%) 1 (2%)
Ulcer 1 (2%) 4 (8%) 4 (8%) 4 (8%)
Epithelium, Hyperplasia 2 (4%) 5 (10%) 4 (8%) 6 (12%)
Stomach, Glandular (49) (50) (50) (50)
Atypia Cellular, Focal 1 (2%)
Edema 1 (2%)
Erosion 2 (4%) 4 (8%) 1 (2%) 4 (8%)
Fibrosis, Focal 1 (2%)
Infarct 1 (2%)
Inflammation, Focal 1 (2%)
Pigmentation, Focal 1 (2%) 1 (2%)
Ulcer 1 (2%)
Artery, Inflammation, Chronic 1 (2%)
Epithelium, Hyperplasia 2 (4%)
Epithelium, Hyperplasia, Focal 1 (2%)
Glands, Ectasia, Focal 1 (2%) 1 (2%)
Glands, Necrosis, Focal 1 (2%)
Tongue (1) (1) (1) (1)
Infiltration Cellular, Focal, Mixed Cell 1 (100%)
Epithelium, Hyperplasia, Focal 1 (100%)
Tooth (1)
Epithelium Alveolus, Hyperplasia 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/L 175 MG/L 350 MG/L 700 MG/L
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Cardiomyopathy 16 (32%) 18 (36%) 21 (42%) 14 (28%)
Fibrosis, Focal 1 (2%)
Infiltration Cellular, Mixed Cell 1 (2%)
Thrombosis 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49)
Accessory Adrenal Cortical Nodule 14 (28%) 8 (16%) 8 (16%) 14 (29%)
Angiectasis 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%) 3 (6%) 3 (6%) 2 (4%)
Infiltration Cellular, Mixed Cell 1 (2%)
Necrosis, Focal 2 (4%) 1 (2%) 1 (2%)
Vacuolization Cytoplasmic, Focal 9 (18%) 5 (10%) 8 (16%) 12 (24%)
Adrenal Medulla (50) (50) (50) (49)
Cytoplasmic Alteration, Focal 1 (2%)
Hemorrhage 1 (2%)
Hyperplasia 1 (2%)
Hyperplasia, Focal 11 (22%) 17 (34%) 15 (30%) 13 (27%)
Necrosis, Focal 1 (2%) 1 (2%)
Thrombosis 1 (2%)
Bilateral, Hyperplasia, Focal 1 (2%)
Islets, Pancreatic (49) (50) (50) (49)
Hyperplasia 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Focal 2 (4%)
Parathyroid Gland (48) (49) (50) (50)
Cyst 1 (2%)
Hyperplasia, Focal 1 (2%)
Pituitary Gland (49) (50) (50) (48)
Angiectasis 2 (4%) 2 (4%) 1 (2%)
Craniopharyngeal Duct, Cyst 1 (2%)
Pars Distalis, Cyst 2 (4%) 2 (4%) 2 (4%) 2 (4%)
Pars Distalis, Cytoplasmic Alteration, Focal 7 (14%) 6 (12%) 1 (2%) 6 (13%)
Pars Distalis, Degeneration, Cystic, Focal 1 (2%) 3 (6%)
Pars Distalis, Hemorrhage, Focal 3 (6%) 5 (10%) 1 (2%) 3 (6%)
Pars Distalis, Hyperplasia, Focal 3 (6%) 2 (4%) 2 (4%) 7 (15%)
Pars Distalis, Necrosis, Focal 1 (2%)
Pars Intermedia, Cyst 1 (2%)
Rathke's Cleft, Cyst 2 (4%) 2 (4%)
Rathke's Cleft, Hemorrhage 1 (2%)
Thyroid Gland (46) (48) (44) (42)
Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/L 175 MG/L 350 MG/L 700 MG/L
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
C-Cell, Hyperplasia 44 (96%) 46 (96%) 40 (91%) 41 (98%)
Follicle, Degeneration, Cystic, Focal 2 (4%)
Follicular Cell, Hyperplasia 2 (5%)
Follicular Cell, Hyperplasia, Cystic, Focal 5 (11%) 4 (8%) 4 (9%) 3 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (49) (50) (50) (50)
Inflammation, Chronic 1 (2%)
Preputial Gland (50) (50) (50) (49)
Degeneration, Cystic 1 (2%) 1 (2%) 2 (4%)
Fibrosis 1 (2%)
Hyperplasia, Cystic 2 (4%) 1 (2%) 1 (2%) 2 (4%)
Inflammation, Chronic 32 (64%) 30 (60%) 31 (62%) 37 (76%)
Prostate (50) (50) (50) (50)
Inflammation, Chronic 29 (58%) 33 (66%) 35 (70%) 38 (76%)
Mineralization, Focal 2 (4%)
Epithelium, Hyperplasia, Focal 25 (50%) 21 (42%) 24 (48%) 23 (46%)
Seminal Vesicle (50) (50) (50) (50)
Dilatation 1 (2%)
Inflammation, Chronic 1 (2%)
Testes (50) (50) (50) (50)
Atrophy 5 (10%) 8 (16%) 8 (16%) 8 (16%)
Necrosis 1 (2%)
Artery, Thrombosis, Focal 1 (2%)
Bilateral, Atrophy 1 (2%) 1 (2%) 1 (2%)
Bilateral, Interstitial Cell, Hyperplasia,
Focal 1 (2%)
Interstitial Cell, Hyperplasia 1 (2%)
Interstitial Cell, Hyperplasia, Focal 3 (6%) 1 (2%) 3 (6%) 3 (6%)
Tunic, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (45) (49) (49)
Hyperplasia 2 (4%) 2 (4%) 5 (10%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/L 175 MG/L 350 MG/L 700 MG/L
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Focal, Histiocytic 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 1 (2%)
Myeloid Cell, Hyperplasia 2 (4%) 3 (6%) 1 (2%)
Myeloid Cell, Erythroid Cell, Hyperplasia 1 (2%) 5 (11%) 5 (10%)
Lymph Node (25) (28) (26) (26)
Bronchial, Hyperplasia, Plasma Cell 1 (4%)
Deep Cervical, Ectasia 1 (4%)
Mediastinal, Angiectasis 2 (8%) 1 (4%)
Mediastinal, Ectasia 3 (12%) 1 (4%) 3 (12%) 4 (15%)
Mediastinal, Hemorrhage 1 (4%) 2 (8%)
Mediastinal, Hyperplasia 1 (4%)
Mediastinal, Hyperplasia, Histiocytic 2 (8%) 1 (4%) 2 (8%)
Mediastinal, Hyperplasia, Lymphoid 1 (4%) 1 (4%) 1 (4%)
Mediastinal, Hyperplasia, Plasma Cell 1 (4%) 3 (11%) 6 (23%) 1 (4%)
Mediastinal, Inflammation 1 (4%)
Pancreatic, Angiectasis 1 (4%)
Pancreatic, Ectasia 3 (12%) 5 (18%) 3 (12%) 5 (19%)
Pancreatic, Hemorrhage 1 (4%) 2 (8%) 1 (4%)
Pancreatic, Hyperplasia, Histiocytic 3 (12%) 7 (25%) 5 (19%)
Pancreatic, Pigmentation 1 (4%) 1 (4%) 1 (4%)
Lymph Node, Mesenteric (50) (49) (50) (50)
Ectasia 1 (2%)
Hemorrhage 2 (4%) 1 (2%)
Hyperplasia, Histiocytic 2 (4%) 1 (2%)
Spleen (48) (49) (49) (50)
Accessory Spleen 1 (2%) 1 (2%) 1 (2%)
Angiectasis, Focal 1 (2%) 2 (4%)
Congestion 1 (2%) 1 (2%)
Fibrosis, Focal 4 (8%) 3 (6%) 1 (2%) 1 (2%)
Hematopoietic Cell Proliferation 6 (13%) 7 (14%) 5 (10%) 11 (22%)
Hemorrhage 2 (4%)
Hemorrhage, Chronic 1 (2%)
Hyperplasia, Focal, Histiocytic 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Infarct 2 (4%) 1 (2%) 1 (2%)
Necrosis, Focal 1 (2%)
Pigmentation 1 (2%)
Artery, Thrombosis 1 (2%)
Capsule, Fibrosis, Focal 1 (2%)
Thymus (48) (48) (50) (47)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/L 175 MG/L 350 MG/L 700 MG/L
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (44) (45) (47) (42)
Atypia Cellular, Focal 1 (2%)
Dilatation 8 (18%) 18 (40%) 16 (34%) 12 (29%)
Ectasia 1 (2%) 1 (2%)
Fibrosis 1 (2%)
Fibrosis, Focal 1 (2%)
Hyperplasia 2 (5%) 3 (7%) 2 (4%) 1 (2%)
Skin (50) (50) (50) (50)
Cyst Epithelial Inclusion 2 (4%)
Hyperkeratosis, Focal 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
Mineralization, Focal 1 (2%)
Subcutaneous Tissue, Angiectasis, Focal 1 (2%) 1 (2%)
Subcutaneous Tissue, Cyst, Chronic 1 (2%)
Subcutaneous Tissue, Cyst Epithelial
Inclusion 1 (2%)
Subcutaneous Tissue, Edema 1 (2%)
Subcutaneous Tissue, Hemorrhage, Focal 1 (2%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Inflammation, Focal,
Granulomatous 1 (2%)
Subcutaneous Tissue, Metaplasia, Focal,
Osseous 1 (2%)
Subcutaneous Tissue, Necrosis, Fatty, Focal 1 (2%)
Subcutaneous Tissue, Epidermis, Hyperplasia,
Focal 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (50) (50) (50)
Hyperostosis 1 (2%)
Skeletal Muscle (3) (2)
Hemorrhage, Focal 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Compression, Focal 6 (12%) 8 (16%) 14 (28%) 14 (28%)
Hemorrhage, Focal 2 (4%) 4 (8%) 1 (2%) 3 (6%)
Hydrocephalus 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/L 175 MG/L 350 MG/L 700 MG/L
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM - CONT
Necrosis, Focal 1 (2%) 2 (4%)
Cerebellum, Hemorrhage, Focal 1 (2%)
Cerebrum, Ventricle, Hydrocephalus 1 (2%)
Pineal Gland, Vacuolization Cytoplasmic 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Congestion 4 (8%) 1 (2%) 3 (6%) 5 (10%)
Fibrosis, Focal 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hemorrhage, Focal 3 (6%) 1 (2%) 2 (4%) 2 (4%)
Hyperplasia, Focal, Histiocytic 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 1 (2%) 1 (2%) 2 (4%)
Infiltration Cellular, Mixed Cell 2 (4%) 1 (2%)
Inflammation, Chronic, Focal 2 (4%) 3 (6%) 2 (4%)
Metaplasia, Squamous 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 7 (14%) 6 (12%) 9 (18%) 5 (10%)
Interstitium, Edema 1 (2%)
Mediastinum, Angiectasis, Focal 1 (2%)
Nose (50) (50) (50) (50)
Hemorrhage 1 (2%)
Inflammation, Suppurative 2 (4%) 3 (6%) 3 (6%) 3 (6%)
Nasolacrimal Duct, Inflammation 3 (6%) 1 (2%)
Olfactory Epithelium, Mineralization, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (49) (49) (48) (47)
Cataract 2 (4%) 1 (2%) 7 (15%)
Inflammation, Chronic 1 (2%)
Retina, Degeneration 3 (6%) 1 (2%) 8 (17%) 1 (2%)
Harderian Gland (50) (50) (50) (48)
Hyperplasia, Focal, Histiocytic 1 (2%)
Hyperplasia, Focal, Lymphoid 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation, Chronic, Focal 1 (2%) 1 (2%)
Epithelium, Hyperplasia, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 96018-03 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) Date: 05/24/04
Route: DOSED WATER Time: 09:31:58
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 MG/L 175 MG/L 350 MG/L 700 MG/L
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (50) (50) (49)
Cyst 1 (2%)
Infarct 3 (6%) 1 (2%)
Metaplasia, Focal, Osseous 1 (2%)
Nephropathy 49 (100%) 50 (100%) 49 (98%) 46 (94%)
Artery, Thrombosis 1 (2%)
Cortex, Necrosis, Focal 1 (2%)
Pelvis, Dilatation 1 (2%)
Pelvis, Transitional Epithelium, Hyperplasia 1 (2%)
Renal Tubule, Hyperplasia, Atypical, Focal 1 (2%)
Renal Tubule, Pigmentation 10 (20%) 13 (26%) 7 (14%) 3 (6%)
Urinary Bladder (49) (50) (50) (49)
Hemorrhage 1 (2%) 1 (2%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------