TDMS Study 05086-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) O-BENZYL-P-CHLOROPHENOL NTP Experiment-Test: 05086-01 Report: PEIRPT03 Study Type: CHRONIC Date: 09/11/94 Route: GAVAGE Time: 06:48:22 Facility: Battelle Columbus Laboratory Chemical CAS #: 120-32-1 Lock Date: None 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: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0MG/KG 0MG/KG 0MG/KG 60MG/KG 60MG/KG 60MG/KG F 13HUCC F 65HUCC F F 13HUCC F 65HUCC F ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 10 10 60 10 10 Scheduled Sacrifice 10 10 10 10 10 9 Early Deaths Moribund Sacrifice 17 12 Dosing Accident 2 1 Natural Death 5 7 1 Survivors Terminal Sacrifice 26 30 Animals Examined Microscopically 60 10 60 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (60) (10) (50) Muscularis, Inflammation, Chronic 1 (10%) Intestine Large, Colon (59) (10) (50) Parasite Metazoan 3 (5%) Intestine Large, Rectum (59) (10) (50) Parasite Metazoan 3 (5%) 1 (10%) 6 (12%) Intestine Small, Duodenum (60) (10) (50) Inflammation, Necrotizing 2 (3%) Liver (60) (10) (54) Basophilic Focus 41 (68%) 43 (80%) Clear Cell Focus 6 (10%) 10 (19%) Eosinophilic Focus 1 (2%) 2 (4%) Fatty Change 1 (2%) 4 (7%) Hepatodiaphragmatic Nodule 8 (13%) 9 (17%) Inflammation, Granulomatous 8 (13%) 9 (17%) Mixed Cell Focus 3 (6%) Bile Duct, Hyperplasia 35 (58%) 37 (69%) Centrilobular, Necrosis 3 (6%) Mesentery (4) (3) Fat, Necrosis 4 (100%) 2 (67%) Pancreas (60) (10) (50) Inflammation, Chronic 1 (10%) Acinus, Atrophy 11 (18%) 12 (24%) Acinus, Hyperplasia 4 (7%) 1 (2%) Pharynx (1) Inflammation, Suppurative 1 (100%) Salivary Glands (60) (10) (50) Inflammation, Chronic Active 1 (2%) Stomach, Forestomach (60) (10) (50) Inflammation, Chronic 1 (2%) Inflammation, Necrotizing 2 (3%) 2 (4%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0MG/KG 0MG/KG 0MG/KG 60MG/KG 60MG/KG 60MG/KG F 13HUCC F 65HUCC F F 13HUCC F 65HUCC F ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Epithelium, Hyperplasia 1 (2%) 2 (4%) Stomach, Glandular (59) (10) (50) Inflammation, Necrotizing 1 (2%) 3 (6%) Mineralization 3 (5%) 2 (4%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (10) (50) Thrombosis 1 (2%) Myocardium, Degeneration, Chronic 40 (67%) 3 (30%) 43 (86%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (60) (10) (50) Hyperplasia 15 (25%) 14 (28%) Hypertrophy 1 (2%) 2 (4%) Necrosis 1 (2%) 2 (4%) Adrenal Gland, Medulla (60) (10) (50) Hyperplasia 8 (13%) 4 (8%) Islets, Pancreatic (60) (10) (50) Hyperplasia 1 (2%) Parathyroid Gland (56) (10) (44) Hyperplasia 1 (2%) Pituitary Gland (60) (10) (51) Pars Distalis, Ectasia 1 (2%) Pars Distalis, Hyperplasia 27 (45%) 22 (43%) Pars Intermedia, Hyperplasia 1 (2%) Thyroid Gland (60) (10) (50) C-Cell, Hyperplasia 19 (32%) 8 (16%) Follicular Cell, Hyperplasia 5 (8%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (59) (10) (48) Hyperplasia 1 (2%) 2 (4%) Inflammation, Chronic Active 2 (3%) 2 (4%) Duct, Dilatation 1 (2%) Ovary (60) (10) (52) (1) Cyst 2 (3%) 4 (8%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0MG/KG 0MG/KG 0MG/KG 60MG/KG 60MG/KG 60MG/KG F 13HUCC F 65HUCC F F 13HUCC F 65HUCC F ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Periovarian Tissue, Cyst 1 (2%) 1 (2%) Vagina (1) Inflammation, Acute 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (10) (50) Femoral, Hyperplasia, Reticulum Cell 1 (10%) Lymph Node, Mesenteric (59) (10) (48) Edema 1 (2%) Spleen (60) (10) (50) Fibrosis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Thymus (58) (10) (46) Cyst 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (59) (9) (50) Hyperplasia 1 (2%) Skin (60) (10) (50) Inflammation, Chronic Active 2 (3%) 1 (2%) Subcutaneous Tissue, Edema 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) Hemorrhage 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (10) (50) Compression 5 (8%) 2 (4%) Developmental Malformation 1 (2%) Infarct 1 (2%) Inflammation, Granulomatous 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0MG/KG 0MG/KG 0MG/KG 60MG/KG 60MG/KG 60MG/KG F 13HUCC F 65HUCC F F 13HUCC F 65HUCC F ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (10) (50) Foreign Body 1 (2%) 2 (4%) Inflammation, Chronic Active 8 (13%) 2 (20%) 1 (2%) Inflammation, Necrotizing 2 (3%) 1 (2%) Alveolar Epithelium, Hyperplasia 4 (7%) 8 (16%) Nose (60) (10) (50) Mucosa, Inflammation, Suppurative 2 (3%) 3 (6%) Nasolacrimal Duct, Inflammation, Suppurative 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (4) Degeneration 1 (25%) Lens, Cataract 1 (100%) 2 (50%) Retina, Atrophy 1 (100%) 1 (25%) Harderian Gland (1) (1) Inflammation, Chronic Active 1 (100%) Zymbal's Gland (1) Cyst 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (10) (60) (10) Infarct 1 (2%) Nephropathy 55 (92%) 1 (10%) 57 (95%) 3 (30%) Corticomedullary Junction, Concretion 1 (10%) Corticomedullary Junction, Mineralization 5 (50%) 6 (60%) Pelvis, Inflammation, Suppurative 1 (2%) Pelvis, Mineralization 3 (5%) 2 (3%) Urinary Bladder (60) (10) (50) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 120MG/KG 120MG/KG 120MG/KG 240MG/KG 240MG/KG 240MG/KG F 13HUCC F 65HUCC F F 13HUCC F 65HUCC F ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 10 10 60 10 10 Scheduled Sacrifice 9 8 9 10 9 8 Early Deaths Moribund Sacrifice 15 18 Natural Death 7 1 3 1 Dosing Accident 1 2 1 2 Survivors Terminal Sacrifice 28 28 Animals Examined Microscopically 60 8 60 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (52) (60) (10) Foreign Body 1 (2%) Inflammation, Chronic Active 2 (4%) Inflammation, Necrotizing 1 (2%) Muscularis, Inflammation, Chronic 1 (10%) Intestine Large, Cecum (51) (60) (10) Inflammation, Necrotizing 1 (2%) Intestine Large, Rectum (51) (60) (9) Parasite Metazoan 3 (6%) 1 (2%) Intestine Small, Duodenum (51) (60) (10) Inflammation, Necrotizing 1 (2%) Liver (52) (60) (10) Basophilic Focus 41 (79%) 43 (72%) Clear Cell Focus 9 (17%) 16 (27%) Degeneration, Cystic 1 (2%) 2 (3%) Eosinophilic Focus 3 (6%) 2 (3%) Fatty Change 1 (2%) 1 (2%) Hepatodiaphragmatic Nodule 9 (17%) 8 (13%) Inflammation, Granulomatous 5 (10%) 2 (3%) Inflammation, Necrotizing 1 (2%) 2 (3%) Bile Duct, Hyperplasia 33 (63%) 25 (42%) Mesentery (1) (5) Fibrosis 1 (100%) Hemorrhage 1 (20%) Fat, Necrosis 3 (60%) Pancreas (50) (60) (10) Acinus, Atrophy 8 (16%) 16 (27%) Acinus, Hyperplasia 1 (2%) Salivary Glands (50) (60) (10) Inflammation, Chronic Active 1 (2%) Inflammation, Suppurative 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 120MG/KG 120MG/KG 120MG/KG 240MG/KG 240MG/KG 240MG/KG F 13HUCC F 65HUCC F F 13HUCC F 65HUCC F ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Stomach, Forestomach (52) (60) (10) Cyst 1 (2%) Inflammation, Chronic 2 (3%) Inflammation, Necrotizing 1 (2%) 5 (8%) Stomach, Glandular (51) (60) (10) Inflammation, Necrotizing 3 (5%) Mineralization 2 (3%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (51) (60) (10) Mineralization 1 (2%) Myocardium, Degeneration, Chronic 42 (82%) 44 (73%) 2 (20%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (51) (60) (10) Hyperplasia 10 (20%) 26 (43%) Hypertrophy 4 (8%) 2 (3%) Necrosis 1 (2%) Adrenal Gland, Medulla (51) (60) (10) Hyperplasia 3 (6%) 10 (17%) Parathyroid Gland (46) (57) (8) Hyperplasia 1 (2%) Pituitary Gland (51) (60) (10) Pars Distalis, Ectasia 1 (2%) Pars Distalis, Hyperplasia 30 (59%) 28 (47%) Pars Intermedia, Hyperplasia 1 (2%) 1 (2%) Thyroid Gland (51) (60) (10) C-Cell, Hyperplasia 11 (22%) 22 (37%) Follicular Cell, Hyperplasia 1 (2%) 4 (7%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (56) (10) Hyperplasia 5 (10%) 1 (2%) Inflammation, Chronic Active 1 (2%) 1 (2%) Duct, Dilatation 2 (4%) Ovary (51) (60) (10) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 120MG/KG 120MG/KG 120MG/KG 240MG/KG 240MG/KG 240MG/KG F 13HUCC F 65HUCC F F 13HUCC F 65HUCC F ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Cyst 3 (6%) 1 (2%) Uterus (53) (60) (10) Dilatation 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (51) (60) (10) Femoral, Hyperplasia, Reticulum Cell 1 (10%) Lymph Node (51) (60) (10) Mediastinal, Edema 1 (2%) Spleen (51) (60) (10) Hematopoietic Cell Proliferation 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (60) (10) Hyperplasia 2 (4%) Skin (50) (60) (10) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (51) (60) (10) Compression 1 (2%) 6 (10%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (51) (59) (10) Inflammation, Chronic Active 1 (2%) 4 (7%) 2 (20%) Inflammation, Necrotizing 1 (2%) Mineralization 2 (3%) Alveolar Epithelium, Hyperplasia 2 (4%) 7 (12%) Nose (51) (60) (10) Mucosa, Inflammation, Suppurative 6 (12%) 4 (7%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 120MG/KG 120MG/KG 120MG/KG 240MG/KG 240MG/KG 240MG/KG F 13HUCC F 65HUCC F F 13HUCC F 65HUCC F ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (7) (1) (6) (1) Degeneration 2 (29%) 3 (50%) Inflammation, Chronic Active 2 (33%) Lens, Cataract 3 (43%) 1 (100%) 1 (17%) 1 (100%) Retina, Atrophy 3 (43%) 1 (100%) Harderian Gland (1) (1) Inflammation, Chronic Active 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (8) (60) (10) Atrophy 1 (2%) Calculus Micro Observation Only 2 (3%) Mineralization 1 (2%) Nephropathy 59 (98%) 3 (38%) 60 (100%) 7 (70%) Corticomedullary Junction, Mineralization 3 (38%) 1 (10%) Pelvis, Inflammation, Suppurative 1 (2%) 2 (3%) Pelvis, Mineralization 2 (3%) 16 (27%) Renal Tubule, Hyperplasia 1 (2%) Urinary Bladder (51) (60) (10) Transitional Epithelium, Hyperplasia 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0MG/KG 0MG/KG 0MG/KG 30MG/KG 30MG/KG 30MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 10 10 60 10 10 Scheduled Sacrifice 10 10 10 10 10 10 Early Deaths Moribund Sacrifice 16 13 Natural Death 5 11 Dosing Accident 6 2 Survivors Terminal Sacrifice 23 24 Animals Examined Microscopically 60 10 60 10 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (60) (10) (50) Foreign Body 2 (3%) Inflammation, Chronic Active 3 (5%) Muscularis, Inflammation, Chronic 2 (20%) Intestine Large, Cecum (58) (10) (48) Inflammation, Necrotizing 1 (2%) Intestine Large, Colon (60) (10) (50) Inflammation, Necrotizing 1 (2%) Parasite Metazoan 1 (2%) Intestine Large, Rectum (60) (10) (49) Parasite Metazoan 2 (3%) 1 (10%) 7 (14%) Intestine Small, Jejunum (59) (10) (48) Inflammation, Necrotizing 1 (2%) Liver (60) (10) (51) Basophilic Focus 35 (58%) 33 (65%) Clear Cell Focus 23 (38%) 16 (31%) Degeneration, Cystic 6 (10%) 3 (6%) Eosinophilic Focus 7 (12%) 6 (12%) Fatty Change 7 (12%) 1 (2%) Hepatodiaphragmatic Nodule 2 (3%) 4 (8%) Inflammation, Granulomatous 3 (5%) Inflammation, Necrotizing 2 (3%) Mixed Cell Focus 1 (2%) 3 (6%) Bile Duct, Hyperplasia 46 (77%) 43 (84%) Centrilobular, Necrosis 1 (2%) 9 (18%) Mesentery (14) (14) Hemorrhage 1 (7%) Fat, Necrosis 13 (93%) 8 (57%) Pancreas (59) (10) (47) Basophilic Focus 1 (2%) Acinus, Atrophy 20 (34%) 10 (21%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0MG/KG 0MG/KG 0MG/KG 30MG/KG 30MG/KG 30MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Acinus, Hyperplasia 6 (10%) 11 (23%) Stomach, Forestomach (59) (10) (50) Inflammation, Chronic 1 (2%) Inflammation, Necrotizing 4 (7%) 5 (10%) Epithelium, Hyperplasia 3 (6%) Stomach, Glandular (59) (10) (49) Inflammation, Necrotizing 2 (3%) 7 (14%) Mineralization 2 (3%) 4 (8%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (2) Foreign Body 1 (50%) Inflammation, Chronic Active 1 (50%) Heart (60) (10) (50) Mineralization 1 (2%) Thrombosis 1 (2%) Myocardium, Degeneration, Chronic 55 (92%) 9 (90%) 46 (92%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (60) (10) (50) Hemorrhage, Chronic 1 (2%) Hyperplasia 20 (33%) 12 (24%) Hypertrophy 4 (7%) 1 (2%) Necrosis 1 (2%) Adrenal Gland, Medulla (60) (10) (50) Hemorrhage, Chronic 1 (2%) Hyperplasia 18 (30%) 26 (52%) Islets, Pancreatic (59) (10) (47) Hyperplasia 4 (9%) Parathyroid Gland (56) (9) (47) Hyperplasia 2 (4%) Pituitary Gland (58) (10) (51) Pars Distalis, Ectasia 1 (2%) Pars Distalis, Hyperplasia 20 (34%) 13 (25%) Thyroid Gland (58) (10) (50) C-Cell, Hyperplasia 16 (28%) 8 (16%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 2 (3%) 3 (6%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0MG/KG 0MG/KG 0MG/KG 30MG/KG 30MG/KG 30MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (59) (10) (50) Hyperplasia 1 (2%) Inflammation, Chronic Active 2 (3%) Duct, Dilatation 1 (2%) Prostate (60) (10) (50) Degeneration, Mucoid 1 (2%) Dilatation 1 (2%) Hyperplasia 2 (4%) Inflammation, Chronic Active 5 (8%) 11 (22%) Seminal Vesicle (60) (10) (50) Dilatation 1 (2%) Testes (60) (10) (49) Degeneration 1 (2%) Inflammation, Chronic Active 1 (2%) Interstitial Cell, Hyperplasia 16 (27%) 6 (12%) Seminiferous Tubule, Atrophy 3 (5%) 4 (8%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (59) (10) (50) Sinus, Ectasia 1 (2%) Spleen (60) (10) (49) Fibrosis 4 (7%) 2 (4%) Inflammation, Necrotizing 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (59) (10) (51) Cyst Epithelial Inclusion 1 (2%) Inflammation, Chronic Active 1 (2%) 2 (4%) Subcutaneous Tissue, Fibrosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0MG/KG 0MG/KG 0MG/KG 30MG/KG 30MG/KG 30MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (3) (3) Edema 1 (33%) Diaphragm, Hemorrhage, Chronic 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (10) (50) Compression 6 (10%) 3 (6%) Degeneration 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (10) (50) Fibrosis 1 (2%) Foreign Body 3 (5%) 2 (4%) Inflammation, Chronic Active 9 (15%) 2 (20%) 2 (4%) Inflammation, Necrotizing 5 (8%) 2 (4%) Alveolar Epithelium, Hyperplasia 11 (18%) 10 (20%) Mediastinum, Hemorrhage 1 (2%) Nose (60) (10) (50) Fungus 2 (3%) Mucosa, Inflammation, Suppurative 14 (23%) 1 (10%) 3 (6%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) Lens, Cataract 1 (33%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (10) (59) (10) Mineralization 1 (2%) 2 (3%) Nephropathy 58 (97%) 10 (100%) 58 (98%) 8 (80%) Renal Tubule, Hyperplasia 2 (3%) Transitional Epithelium, Hyperplasia 1 (2%) Urinary Bladder (60) (10) (50) Hemorrhage 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0MG/KG 0MG/KG 0MG/KG 30MG/KG 30MG/KG 30MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 60MG/KG 60MG/KG 60MG/KG 120MG/KG 120MG/KG 120MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 60 10 10 60 10 10 Scheduled Sacrifice 10 10 10 9 9 7 Early Deaths Natural Death 6 8 2 Moribund Sacrifice 14 14 Dosing Accident 5 5 1 1 Survivors Terminal Sacrifice 25 24 Animals Examined Microscopically 60 10 60 9 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (60) (9) Dilatation 1 (2%) Foreign Body 1 (2%) Inflammation, Chronic Active 1 (2%) Muscularis, Inflammation, Chronic 1 (11%) Intestine Large, Rectum (49) (58) (9) Parasite Metazoan 4 (8%) 2 (3%) Intestine Small, Duodenum (49) (59) (9) Inflammation, Necrotizing 1 (2%) 1 (2%) Liver (51) (60) (9) Basophilic Focus 25 (49%) 31 (52%) Clear Cell Focus 21 (41%) 22 (37%) Degeneration, Cystic 6 (12%) Eosinophilic Focus 3 (6%) 7 (12%) Fatty Change 3 (6%) 1 (2%) Hepatodiaphragmatic Nodule 3 (6%) 4 (7%) Inflammation, Granulomatous 1 (2%) 1 (2%) Inflammation, Necrotizing 2 (4%) Mixed Cell Focus 1 (2%) 1 (2%) Bile Duct, Hyperplasia 42 (82%) 35 (58%) Mesentery (7) (8) (1) Hemorrhage 1 (13%) Inflammation, Granulomatous 1 (100%) Fat, Necrosis 7 (100%) 7 (88%) Pancreas (48) (58) (9) Basophilic Focus 3 (5%) Acinus, Atrophy 12 (25%) 19 (33%) Acinus, Hyperplasia 8 (17%) 13 (22%) Salivary Glands (49) (58) (9) Inflammation, Chronic Active 2 (3%) Stomach, Forestomach (49) (60) (9) a Number of animals examined microscopically at site and number of animals with lesion Page 15 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 60MG/KG 60MG/KG 60MG/KG 120MG/KG 120MG/KG 120MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Inflammation, Chronic 3 (5%) Inflammation, Necrotizing 5 (10%) 4 (7%) Mineralization 1 (2%) Epithelium, Hyperplasia 4 (8%) 1 (2%) Stomach, Glandular (49) (59) (9) Inflammation, Necrotizing 4 (8%) 6 (10%) Mineralization 2 (4%) 9 (15%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (60) (9) Inflammation, Necrotizing 1 (2%) 1 (2%) Mineralization 2 (3%) Myocardium, Degeneration, Chronic 46 (92%) 54 (90%) 5 (56%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (60) (9) Accessory Adrenal Cortical Nodule 1 (2%) Hyperplasia 21 (42%) 19 (32%) Hypertrophy 3 (6%) Adrenal Gland, Medulla (49) (59) (9) Hyperplasia 17 (35%) 20 (34%) Islets, Pancreatic (48) (59) (9) Hyperplasia 1 (2%) 1 (2%) Parathyroid Gland (45) (53) (8) Hyperplasia 5 (11%) 8 (15%) Pituitary Gland (49) (60) (9) Pars Distalis, Ectasia 1 (2%) Pars Distalis, Hyperplasia 15 (31%) 13 (22%) Pars Nervosa, Hyperplasia, Glandular 1 (2%) Thyroid Gland (47) (59) (9) C-Cell, Hyperplasia 7 (15%) 11 (19%) Follicle, Cyst 1 (2%) Follicular Cell, Hyperplasia 2 (4%) 3 (5%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 16 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 60MG/KG 60MG/KG 60MG/KG 120MG/KG 120MG/KG 120MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (49) (60) (9) Inflammation, Chronic Active 2 (3%) 1 (11%) Duct, Dilatation 1 (2%) Prostate (50) (60) (9) Inflammation, Chronic Active 7 (14%) 7 (12%) Seminal Vesicle (50) (60) (9) Mineralization 1 (2%) Testes (51) (60) (9) Inflammation, Chronic Active 1 (2%) 3 (5%) Mineralization 1 (2%) Interstitial Cell, Hyperplasia 13 (25%) 20 (33%) Seminiferous Tubule, Atrophy 3 (6%) 3 (5%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (48) (58) (9) Edema 2 (4%) Mineralization 1 (2%) Spleen (50) (59) (9) Fibrosis 3 (6%) 7 (12%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (44) (48) (6) Hyperplasia 1 (2%) Inflammation, Chronic Active 2 (4%) Skin (50) (60) (9) Edema 1 (2%) Inflammation, Chronic Active 3 (6%) 4 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (60) (9) Cranium, Fibrous Osteodystrophy 2 (4%) 4 (7%) Femur, Fibrous Osteodystrophy 2 (4%) 6 (10%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (60) (9) Compression 5 (10%) 1 (2%) Degeneration 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 17 NTP Experiment-Test: 05086-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC O-BENZYL-P-CHLOROPHENOL Date: 09/11/94 Route: GAVAGE Time: 06:48:22 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 60MG/KG 60MG/KG 60MG/KG 120MG/KG 120MG/KG 120MG/KG M 13HUCC M 65HUCC M M 13HUCC M 65HUCC M ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (60) (9) Foreign Body 4 (8%) 3 (5%) Inflammation, Chronic Active 6 (12%) 4 (7%) 2 (22%) Inflammation, Necrotizing 4 (8%) 5 (8%) Mineralization 2 (3%) Alveolar Epithelium, Hyperplasia 12 (24%) 10 (17%) Mediastinum, Hemorrhage 1 (2%) Nose (48) (60) (9) Foreign Body 1 (2%) Mucosa, Inflammation, Suppurative 7 (15%) 6 (10%) Trachea (50) (59) (9) Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) Pinna, Inflammation, Chronic Active 1 (50%) Eye (1) (7) Degeneration 1 (100%) 2 (29%) Inflammation, Chronic Active 3 (43%) Cornea, Mineralization 1 (14%) Lens, Cataract 1 (14%) Retina, Atrophy 1 (14%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (10) (59) (9) Mineralization 3 (5%) Nephropathy 58 (97%) 9 (90%) 59 (100%) 8 (89%) Pelvis, Inflammation, Suppurative 1 (2%) Renal Tubule, Hyperplasia 2 (3%) Transitional Epithelium, Hyperplasia 2 (3%) 1 (2%) Urinary Bladder (50) (59) (9) Inflammation, Chronic Active 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 18 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------