TDMS Study 97013-08 Pathology Tables
NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/11/04 Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 08:49:14 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 b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 1 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/11/04 Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 08:49:14 ____________________________________________________________________________________________________________________________________ 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 1 Liver (15) (15) (15) (15) Basophilic Focus 1 Cyst 1 [2.0] Hematopoietic Cell Proliferation 1 [1.0] 1 [1.0] 1 [1.0] Hemorrhage 1 [2.0] Hepatodiaphragmatic Nodule 1 Inflammation 11 [1.0] 13 [1.0] 13 [1.1] 13 [1.1] Necrosis 1 [1.0] 4 [1.0] 1 [1.0] Hepatocyte, Fatty Change 5 [1.0] 8 [1.0] 7 [1.1] Hepatocyte, Vacuolization Cytoplasmic 6 [1.0] 4 [1.3] 3 [1.0] Salivary Glands (1) (1) Atrophy 1 [2.0] Stomach, Forestomach (15) (15) (15) (15) Hyperkeratosis 1 [1.0] Epithelium, Hyperplasia 1 [1.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (15) Mineralization 1 [1.0] Subcapsular, Hyperplasia 7 [1.0] 10 [1.0] 8 [1.0] 6 [1.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 2 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/11/04 Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 08:49:14 ____________________________________________________________________________________________________________________________________ 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 [1.0] Pituitary Gland (15) (15) (15) (15) Angiectasis 1 [2.0] Cyst 1 [1.0] 1 [1.0] 2 [1.0] Thyroid Gland (15) (15) (15) (15) Cyst 2 [1.0] 2 [1.0] 3 [1.3] 1 [1.0] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (15) (15) (15) (15) Atrophy 1 [2.0] Cyst 4 [1.3] 2 [1.0] 4 [1.5] 4 [1.3] Uterus (15) (15) (15) (15) Atrophy 1 [2.0] Inflammation 1 [1.0] Endometrium, Hyperplasia, Cystic 12 [1.0] 9 [1.0] 12 [1.0] 13 [1.1] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (14) (15) (15) (15) Hyperplasia 1 [2.0] Infiltration Cellular, Plasma Cell 1 [2.0] 1 [1.0] Lymph Node, Mesenteric (14) (15) (15) (15) Atrophy 1 [3.0] Spleen (15) (15) (15) (15) Hematopoietic Cell Proliferation 2 [1.0] 1 [1.0] Lymphoid Follicle, Atrophy 3 [1.7] 1 [2.0] Thymus (13) (15) (15) (15) Atrophy 2 [3.0] 3 [2.0] 1 [2.0] 3 [2.7] Cyst 2 [1.0] 5 [1.0] 5 [1.0] 2 [1.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 3 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/11/04 Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 08:49:14 ____________________________________________________________________________________________________________________________________ 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 [1.0] Thrombosis 1 [1.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (15) Casts Protein 4 [1.0] 5 [1.0] 5 [1.0] 4 [1.0] Cyst 1 [1.0] 2 [1.0] Mineralization 1 [1.0] Nephropathy 1 [1.0] 3 [1.0] 3 [1.0] 1 [1.0] Renal Tubule, Degeneration 1 [1.0] Renal Tubule, Dilatation 1 [1.0] Renal Tubule, Hypertrophy 1 [1.0] 1 [1.0] 1 [1.0] 8 [1.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 4 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/11/04 Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 08:49:14 ____________________________________________________________________________________________________________________________________ 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 [2.0] Liver (15) (15) (15) (15) Cyst 1 [2.0] Hematopoietic Cell Proliferation 1 [2.0] Inflammation 6 [1.0] 7 [1.0] 9 [1.0] 8 [1.0] Necrosis 1 [1.0] 1 [1.0] Hepatocyte, Fatty Change 1 [1.0] Hepatocyte, Vacuolization Cytoplasmic 3 [1.3] 1 [1.0] 3 [1.0] 3 [1.0] Mesentery (1) (1) Fat, Necrosis 1 [4.0] 1 [3.0] Stomach, Forestomach (15) (15) (15) (15) Hyperkeratosis 1 [1.0] Tooth (3) (2) (3) (3) Inflammation 1 [3.0] ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (15) Hypertrophy 6 [1.3] 8 [1.1] 5 [1.0] 7 [1.0] Subcapsular, Hyperplasia 2 [1.0] Pituitary Gland (15) (15) (15) (15) Cyst 2 [1.0] 2 [1.5] 1 [2.0] 1 [1.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 5 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/11/04 Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 08:49:14 ____________________________________________________________________________________________________________________________________ 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 [1.0] 2 [1.0] 1 [2.0] ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (15) (15) (15) (15) Inflammation 1 [1.0] Preputial Gland (2) Cyst 1 [2.0] Duct, Ectasia 1 [2.0] Testes (15) (15) (15) (15) Germinal Epithelium, Degeneration 1 [2.0] 4 [2.5] 1 [2.0] ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (15) (15) (15) (15) Atrophy 1 [2.0] Hyperplasia 1 [1.0] 2 [1.0] Infiltration Cellular, Plasma Cell 2 [2.0] Lymph Node, Mesenteric (15) (14) (15) (15) Atrophy 1 [3.0] 1 [2.0] Spleen (15) (15) (15) (15) Hematopoietic Cell Proliferation 1 [1.0] 1 [2.0] 2 [1.0] Lymphoid Follicle, Atrophy 1 [2.0] 1 [2.0] Thymus (14) (15) (15) (15) Atrophy 2 [2.0] 1 [2.0] 3 [2.7] 2 [2.5] Cyst 7 [1.0] 5 [1.0] 4 [1.0] 8 [1.0] ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM None ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 6 NTP Experiment-Test: 97013-08 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18 Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/11/04 Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 08:49:14 ____________________________________________________________________________________________________________________________________ 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 [2.0] Inflammation 1 [1.0] Alveolar Epithelium, Hyperplasia 1 [2.0] ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (15) Casts Protein 3 [1.3] 6 [1.3] Cyst 1 [1.0] Hydronephrosis 1 [1.0] Nephropathy 2 [1.0] 8 [1.0] 3 [1.0] 4 [1.0] Artery, Inflammation 1 [1.0] Renal Tubule, Degeneration 4 [1.0] Renal Tubule, Dilatation 2 [1.0] 1 [1.0] 5 [1.0] 4 [1.0] Renal Tubule, Hypertrophy 4 [1.0] 1 [1.0] Renal Tubule, Necrosis 1 [2.0] a Number of animals examined microscopically at site and number of animals with lesion b Average severity grade (1-minimal;2-mild;3-moderate;4-marked) Page 7 ------------------------------------------------------------ ---------- END OF REPORT 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