TDMS Study 97013-08 Pathology Tables
NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 06/11/04 Route: GAVAGE Time: 08:45:50 FINAL#1 MICE Facility: Battelle Columbus Laboratory Chemical CAS #: 75-27-4 Lock Date: 07/19/01 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include 002 0 MG/KG Include 004 25 MG/KG Include 006 50 MG/KG Include 008 100 MG/KG Include 001 0 MG/KG Include 003 25 MG/KG Include 005 50 MG/KG Include 007 100 MG/KG a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 06/11/04 Route: GAVAGE Time: 08:45:50 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 15 15 15 15 Early Deaths Moribund Sacrifice 1 1 Dosing Accident 1 1 Natural Death 2 1 2 Survivors Terminal Sacrifice 11 14 13 13 Animals Examined Microscopically 15 15 15 15 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (1) (1) Perforation 1 (100%) 1 (100%) Liver (15) (15) (15) (15) Basophilic Focus 1 (7%) Cyst 1 (7%) Hematopoietic Cell Proliferation 1 (7%) 1 (7%) 1 (7%) Hemorrhage 1 (7%) Hepatodiaphragmatic Nodule 1 (7%) Inflammation 11 (73%) 13 (87%) 13 (87%) 13 (87%) Necrosis 1 (7%) 4 (27%) 1 (7%) Hepatocyte, Fatty Change 5 (33%) 8 (53%) 7 (47%) Hepatocyte, Vacuolization Cytoplasmic 6 (40%) 4 (27%) 3 (20%) Salivary Glands (1) (1) Atrophy 1 (100%) Stomach, Forestomach (15) (15) (15) (15) Hyperkeratosis 1 (7%) Epithelium, Hyperplasia 1 (7%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (15) Mineralization 1 (7%) Subcapsular, Hyperplasia 7 (47%) 10 (67%) 8 (53%) 6 (40%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 06/11/04 Route: GAVAGE Time: 08:45:50 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Parathyroid Gland (1) Cyst 1 (100%) Pituitary Gland (15) (15) (15) (15) Angiectasis 1 (7%) Cyst 1 (7%) 1 (7%) 2 (13%) Thyroid Gland (15) (15) (15) (15) Cyst 2 (13%) 2 (13%) 3 (20%) 1 (7%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (15) (15) (15) (15) Atrophy 1 (7%) Cyst 4 (27%) 2 (13%) 4 (27%) 4 (27%) Uterus (15) (15) (15) (15) Atrophy 1 (7%) Inflammation 1 (7%) Endometrium, Hyperplasia, Cystic 12 (80%) 9 (60%) 12 (80%) 13 (87%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (14) (15) (15) (15) Hyperplasia 1 (7%) Infiltration Cellular, Plasma Cell 1 (7%) 1 (7%) Lymph Node, Mesenteric (14) (15) (15) (15) Atrophy 1 (7%) Spleen (15) (15) (15) (15) Hematopoietic Cell Proliferation 2 (13%) 1 (7%) Lymphoid Follicle, Atrophy 3 (20%) 1 (7%) Thymus (13) (15) (15) (15) Atrophy 2 (15%) 3 (20%) 1 (7%) 3 (20%) Cyst 2 (15%) 5 (33%) 5 (33%) 2 (13%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 06/11/04 Route: GAVAGE Time: 08:45:50 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (15) (15) (15) Inflammation 2 (13%) Thrombosis 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (15) Casts Protein 4 (27%) 5 (33%) 5 (33%) 4 (27%) Cyst 1 (7%) 2 (13%) Mineralization 1 (7%) Nephropathy 1 (7%) 3 (20%) 3 (20%) 1 (7%) Renal Tubule, Degeneration 1 (7%) Renal Tubule, Dilatation 1 (7%) Renal Tubule, Hypertrophy 1 (7%) 1 (7%) 1 (7%) 8 (53%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 06/11/04 Route: GAVAGE Time: 08:45:50 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 15 15 15 15 Early Deaths Dosing Accident 1 Moribund Sacrifice 1 1 3 Survivors Terminal Sacrifice 13 14 12 14 Natural Death 1 Animals Examined Microscopically 15 15 15 15 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (1) Inflammation 1 (100%) Liver (15) (15) (15) (15) Cyst 1 (7%) Hematopoietic Cell Proliferation 1 (7%) Inflammation 6 (40%) 7 (47%) 9 (60%) 8 (53%) Necrosis 1 (7%) 1 (7%) Hepatocyte, Fatty Change 1 (7%) Hepatocyte, Vacuolization Cytoplasmic 3 (20%) 1 (7%) 3 (20%) 3 (20%) Mesentery (1) (1) Fat, Necrosis 1 (100%) 1 (100%) Stomach, Forestomach (15) (15) (15) (15) Hyperkeratosis 1 (7%) Tooth (3) (2) (3) (3) Inflammation 1 (33%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (15) Hypertrophy 6 (40%) 8 (53%) 5 (33%) 7 (47%) Subcapsular, Hyperplasia 2 (13%) Pituitary Gland (15) (15) (15) (15) Cyst 2 (13%) 2 (13%) 1 (7%) 1 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 06/11/04 Route: GAVAGE Time: 08:45:50 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Thyroid Gland (15) (15) (15) (15) Cyst 2 (13%) 2 (13%) 1 (7%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (15) (15) (15) (15) Inflammation 1 (7%) Preputial Gland (2) Cyst 1 (50%) Duct, Ectasia 1 (50%) Testes (15) (15) (15) (15) Germinal Epithelium, Degeneration 1 (7%) 4 (27%) 1 (7%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (15) (15) (15) (15) Atrophy 1 (7%) Hyperplasia 1 (7%) 2 (13%) Infiltration Cellular, Plasma Cell 2 (13%) Lymph Node, Mesenteric (15) (14) (15) (15) Atrophy 1 (7%) 1 (7%) Spleen (15) (15) (15) (15) Hematopoietic Cell Proliferation 1 (7%) 1 (7%) 2 (13%) Lymphoid Follicle, Atrophy 1 (7%) 1 (7%) Thymus (14) (15) (15) (15) Atrophy 2 (14%) 1 (7%) 3 (20%) 2 (13%) Cyst 7 (50%) 5 (33%) 4 (27%) 8 (53%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 06/11/04 Route: GAVAGE Time: 08:45:50 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (15) (15) (15) Edema 1 (7%) Inflammation 1 (7%) Alveolar Epithelium, Hyperplasia 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (15) Casts Protein 3 (20%) 6 (40%) Cyst 1 (7%) Hydronephrosis 1 (7%) Nephropathy 2 (13%) 8 (53%) 3 (20%) 4 (27%) Artery, Inflammation 1 (7%) Renal Tubule, Degeneration 4 (27%) Renal Tubule, Dilatation 2 (13%) 1 (7%) 5 (33%) 4 (27%) Renal Tubule, Hypertrophy 4 (27%) 1 (7%) Renal Tubule, Necrosis 1 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------