TDMS Study 96007-01 Pathology Tables
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
FINAL #3/RATS
Facility: Battelle Columbus Laboratory
Chemical CAS #: 57465-28-8
Lock Date: 01/09/01
Cage Range: All
Reasons For Removal: 25022 Accidently Killed 25018 Dosing Accident
25019 Moribund Sacrifice 25020 Natural Death
25021 Terminal Sacrifice
Removal Date Range: All
Treatment Groups: Include 001 0 NG/KG
Include 003 30 NG/KG
Include 004 100 NG/KG
Include 005 175 NG/KG
Include 006 300 NG/KG
Include 007 550 NG/KG
Include 008 1000 NG/KG
Include 009 1000 NG/KG/STOP
a Number of animals examined microscopically at site and number of animals with lesion
Page 1
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 98 98 98 98 98 98
Early Deaths
Moribund Sacrifice 25 18 21 19 27 18
Natural Death 10 9 6 11 9 12
Accidently Killed 1 3
Dosing Accident 2 1 1
Survivors
Natural Death 1 1
Terminal Sacrifice 15 24 25 22 16 23
Animals Examined Microscopically 53 55 53 53 53 53
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (52) (55) (53) (53) (53) (52)
Hemorrhage 1 (2%)
Hyperplasia, Focal, Squamous 1 (2%)
Muscularis, Degeneration 1 (2%)
Muscularis, Inflammation 2 (4%) 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Periesophageal Tissue, Inflammation,
Suppurative 1 (2%)
Intestine Large, Colon (52) (55) (53) (53) (53) (51)
Hyperplasia, Adenomatous 1 (2%)
Inflammation 1 (2%)
Parasite Metazoan 1 (2%) 2 (4%) 1 (2%)
Intestine Large, Rectum (52) (55) (53) (52) (53) (52)
Infiltration Cellular, Lymphocyte 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%)
Parasite Metazoan 2 (4%) 2 (4%) 3 (6%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Intestine Large, Cecum (52) (54) (53) (51) (53) (52)
Edema 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Inflammation 1 (2%)
Intestine Small, Duodenum (52) (55) (52) (53) (53) (51)
Erosion 1 (2%)
Intestine Small, Ileum (52) (54) (52) (51) (53) (52)
Hyperplasia, Lymphoid 1 (2%)
Mineralization 1 (2%)
Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Serosa, Inflammation, Chronic Active 1 (2%)
Liver (53) (55) (53) (53) (53) (51)
Angiectasis 3 (6%) 8 (15%) 4 (8%) 1 (2%) 1 (2%) 2 (4%)
Basophilic Focus 2 (4%) 4 (7%) 6 (11%) 7 (13%) 2 (4%) 3 (6%)
Basophilic Focus, Multiple 5 (9%) 6 (11%) 4 (8%) 6 (11%) 2 (4%) 2 (4%)
Cholangiofibrosis 1 (2%) 1 (2%) 1 (2%) 3 (6%) 13 (25%)
Clear Cell Focus 1 (2%) 1 (2%)
Clear Cell Focus, Multiple 1 (2%)
Cytoplasmic Alteration 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Degeneration, Cystic 1 (2%) 1 (2%)
Eosinophilic Focus 6 (11%) 4 (7%) 7 (13%) 4 (8%) 2 (4%) 3 (6%)
Eosinophilic Focus, Multiple 5 (9%) 6 (11%) 6 (11%) 17 (32%) 15 (28%) 21 (41%)
Fatty Change, Diffuse 5 (9%) 7 (13%) 14 (26%) 22 (42%) 30 (57%) 45 (88%)
Fatty Change, Focal 2 (4%) 6 (11%) 8 (15%) 6 (11%) 3 (6%) 2 (4%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatocyte, Multinucleate 2 (4%) 10 (19%) 14 (26%) 19 (36%) 46 (90%)
Hepatodiaphragmatic Nodule 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Nodular 1 (2%) 3 (6%) 26 (51%)
Inflammation 36 (68%) 40 (73%) 49 (92%) 50 (94%) 51 (96%) 51 (100%)
Mixed Cell Focus 4 (8%) 6 (11%) 7 (13%) 3 (6%) 3 (6%)
Mixed Cell Focus, Multiple 17 (32%) 18 (33%) 25 (47%) 29 (55%) 30 (57%) 26 (51%)
Necrosis 4 (8%) 2 (4%) 5 (9%) 8 (15%) 11 (21%) 15 (29%)
Pigmentation 1 (2%) 11 (20%) 41 (77%) 39 (74%) 48 (91%) 51 (100%)
Toxic Hepatopathy 6 (11%) 22 (42%) 27 (51%) 39 (74%) 51 (100%)
Vacuolization Cytoplasmic 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%) 1 (2%)
Bile Duct, Cyst 3 (6%) 6 (11%) 2 (4%) 3 (6%) 8 (16%)
Bile Duct, Fibrosis 4 (8%) 4 (7%) 3 (6%) 2 (4%) 1 (2%) 4 (8%)
Bile Duct, Hyperplasia 3 (6%) 7 (13%) 7 (13%) 13 (25%) 14 (26%) 45 (88%)
Hepatocyte, Degeneration 3 (6%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Hepatocyte, Hypertrophy 23 (42%) 32 (60%) 36 (68%) 42 (79%) 50 (98%)
Oval Cell, Hyperplasia 1 (2%) 6 (11%) 7 (13%) 10 (19%) 38 (75%)
Portal, Fibrosis 2 (4%) 1 (2%)
Serosa, Inflammation 1 (2%)
Mesentery (1) (4) (2) (7) (13)
Inflammation, Chronic Active 1 (100%)
Artery, Inflammation, Chronic Active 2 (50%) 2 (100%) 6 (86%) 10 (77%)
Fat, Necrosis 1 (25%) 1 (14%) 1 (8%)
Oral Mucosa (1) (1) (3) (4) (2) (6)
Gingival, Hyperplasia, Squamous 1 (100%) 2 (67%) 2 (50%) 4 (67%)
Pancreas (51) (55) (53) (53) (53) (52)
Basophilic Focus 1 (2%) 1 (2%)
Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation, Chronic Active 5 (10%) 1 (2%) 3 (6%) 4 (8%) 4 (8%) 6 (12%)
Acinus, Atrophy 5 (10%) 3 (5%) 2 (4%) 7 (13%) 2 (4%) 11 (21%)
Acinus, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Acinus, Vacuolization Cytoplasmic 1 (2%) 4 (8%) 9 (17%) 20 (38%)
Artery, Inflammation, Chronic Active 4 (7%) 2 (4%) 4 (8%) 8 (15%) 15 (29%)
Artery, Mineralization 1 (2%) 1 (2%)
Duct, Hyperplasia 1 (2%)
Duct, Inflammation, Chronic Active 2 (4%)
Salivary Glands (51) (54) (53) (51) (52) (51)
Atrophy 1 (2%) 1 (2%)
Cyst 1 (2%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Stomach, Forestomach (52) (55) (53) (53) (53) (51)
Edema 1 (2%) 1 (2%) 1 (2%)
Erosion 1 (2%)
Hyperkeratosis 3 (5%) 1 (2%) 1 (2%) 3 (6%) 1 (2%)
Hyperplasia, Squamous 3 (6%) 4 (7%) 6 (11%) 2 (4%) 5 (9%) 6 (12%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic Active 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Mineralization 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Necrosis, Focal 1 (2%)
Ulcer 3 (6%) 1 (2%) 1 (2%) 3 (6%) 2 (4%)
Stomach, Glandular (51) (53) (53) (53) (53) (51)
Erosion 1 (2%) 1 (2%) 1 (2%)
Metaplasia, Focal 1 (2%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Tooth (12) (12) (10) (9) (10) (9)
Peridontal Tissue, Inflammation, Chronic
Active 2 (17%) 1 (11%)
Peridontal Tissue, Inflammation, Suppurative 10 (83%) 12 (100%) 10 (100%) 9 (100%) 10 (100%) 8 (89%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (53) (55) (53) (53) (53) (53)
Aorta, Mineralization 3 (6%) 1 (2%) 1 (2%) 2 (4%)
Heart (52) (54) (53) (53) (53) (51)
Cardiomyopathy 9 (17%) 16 (30%) 17 (32%) 16 (30%) 24 (45%) 28 (55%)
Degeneration 1 (2%) 1 (2%) 1 (2%)
Inflammation 1 (2%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Thrombosis 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM - CONT
Artery, Inflammation, Chronic Active 1 (2%)
Epicardium, Inflammation, Chronic Active 1 (2%)
Epicardium, Inflammation, Suppurative 2 (4%) 1 (2%)
Myocardium, Inflammation 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (52) (55) (53) (53) (53) (52)
Angiectasis 11 (21%) 13 (24%) 25 (47%) 19 (36%) 20 (38%) 8 (15%)
Atrophy 1 (2%) 3 (5%) 5 (9%) 3 (6%) 5 (9%) 19 (37%)
Degeneration, Cystic 11 (21%) 14 (25%) 10 (19%) 14 (26%) 14 (26%) 16 (31%)
Hyperplasia 23 (44%) 21 (38%) 27 (51%) 25 (47%) 25 (47%) 31 (60%)
Hypertrophy 34 (65%) 41 (75%) 40 (75%) 41 (77%) 40 (75%) 41 (79%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%) 1 (2%)
Necrosis 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Thrombosis 1 (2%)
Vacuolization Cytoplasmic 5 (10%) 3 (5%) 5 (9%) 2 (4%) 9 (17%) 4 (8%)
Adrenal Medulla (52) (55) (53) (53) (53) (52)
Angiectasis 2 (4%) 1 (2%) 2 (4%) 2 (4%)
Hyperplasia 8 (15%) 18 (33%) 11 (21%) 11 (21%) 12 (23%) 6 (12%)
Necrosis 1 (2%)
Islets, Pancreatic (52) (54) (53) (53) (53) (52)
Hyperplasia 1 (2%) 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Parathyroid Gland (47) (50) (48) (46) (49) (47)
Hyperplasia 1 (2%) 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Pituitary Gland (51) (54) (53) (53) (53) (53)
Angiectasis 14 (27%) 15 (28%) 22 (42%) 12 (23%) 16 (30%) 19 (36%)
Cyst 3 (6%) 1 (2%) 1 (2%) 2 (4%)
Cytoplasmic Alteration 1 (2%) 1 (2%) 1 (2%) 3 (6%) 1 (2%)
Inflammation, Focal, Granulomatous 1 (2%)
Necrosis 1 (2%)
Pigmentation 1 (2%)
Vacuolization Cytoplasmic 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia 18 (35%) 20 (37%) 23 (43%) 17 (32%) 21 (40%) 26 (49%)
Thyroid Gland (52) (55) (52) (51) (52) (50)
Angiectasis 1 (2%) 4 (8%)
Cyst 1 (2%) 1 (2%)
C-Cell, Hyperplasia 12 (23%) 21 (38%) 17 (33%) 19 (37%) 18 (35%) 16 (32%)
Follicle, Cyst 1 (2%)
Follicular Cell, Hyperplasia 1 (2%) 1 (2%)
Follicular Cell, Hypertrophy 9 (17%) 13 (24%) 13 (25%) 17 (33%) 28 (54%) 26 (52%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (50) (55) (52) (50) (53) (52)
Hyperplasia 1 (2%)
Hyperplasia, Squamous 1 (2%)
Inflammation 28 (56%) 36 (65%) 39 (75%) 28 (56%) 30 (57%) 27 (52%)
Duct, Cyst 29 (58%) 32 (58%) 34 (65%) 37 (74%) 39 (74%) 42 (81%)
Ovary (52) (54) (53) (52) (52) (52)
Atrophy 45 (87%) 49 (91%) 46 (87%) 45 (87%) 47 (90%) 46 (88%)
Cyst 12 (23%) 17 (31%) 17 (32%) 15 (29%) 16 (31%) 18 (35%)
Inflammation, Chronic Active 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%) 2 (4%)
Necrosis 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
Oviduct (1) (1) (1) (3)
Cyst 1 (33%)
Inflammation, Chronic Active 1 (100%)
Inflammation, Suppurative 1 (100%) 1 (100%) 2 (67%)
Uterus (52) (55) (53) (52) (53) (52)
Adenomyosis 1 (2%) 1 (2%) 2 (4%)
Cyst 1 (2%)
Erosion 1 (2%)
Hemorrhage 1 (2%) 2 (4%) 1 (2%)
Inflammation, Chronic Active 2 (4%) 1 (2%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Inflammation, Suppurative 12 (23%) 12 (22%) 11 (21%) 16 (31%) 10 (19%) 6 (12%)
Metaplasia, Squamous 26 (50%) 33 (60%) 25 (47%) 28 (54%) 29 (55%) 27 (52%)
Thrombosis 1 (2%) 1 (2%)
Ulcer 1 (2%)
Vacuolization Cytoplasmic 2 (4%)
Artery, Inflammation, Chronic Active 1 (2%) 1 (2%)
Cervix, Cyst 1 (2%)
Cervix, Hyperplasia, Stromal 1 (2%)
Endometrium, Hyperplasia, Cystic 23 (44%) 33 (60%) 28 (53%) 24 (46%) 26 (49%) 32 (62%)
Epithelium, Hyperplasia 1 (2%) 1 (2%)
Epithelium, Necrosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (53) (55) (53) (53) (53) (53)
Angiectasis 1 (2%)
Fibrosis 1 (2%)
Hyperplasia 47 (89%) 37 (67%) 35 (66%) 44 (83%) 45 (85%) 46 (87%)
Lymph Node (2) (6) (6) (6) (4) (7)
Ectasia 1 (17%)
Deep Cervical, Ectasia 1 (17%)
Inguinal, Hyperplasia, Plasma Cell 1 (17%)
Inguinal, Pigmentation 1 (17%)
Lumbar, Ectasia 2 (29%)
Lumbar, Hyperplasia 1 (14%)
Lumbar, Hyperplasia, Lymphoid 1 (17%)
Lumbar, Hyperplasia, Plasma Cell 2 (33%) 1 (25%)
Mediastinal, Ectasia 2 (33%) 3 (50%)
Mediastinal, Hemorrhage 2 (33%) 1 (17%) 1 (25%)
Mediastinal, Hyperplasia, Lymphoid 1 (25%)
Mediastinal, Hyperplasia, Plasma Cell 1 (25%) 1 (14%)
Mediastinal, Inflammation, Suppurative 1 (25%)
Pancreatic, Hyperplasia, Plasma Cell 1 (14%)
Lymph Node, Mandibular (52) (53) (51) (51) (52) (51)
Ectasia 1 (2%) 1 (2%) 4 (8%) 4 (8%) 4 (8%) 4 (8%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Hyperplasia, Plasma Cell 18 (35%) 24 (45%) 31 (61%) 21 (41%) 29 (56%) 11 (22%)
Lymph Node, Mesenteric (52) (54) (52) (52) (53) (51)
Atrophy 1 (2%)
Ectasia 1 (2%) 1 (2%)
Hemorrhage 2 (4%) 3 (6%) 1 (2%) 1 (2%)
Hyperplasia, Histiocytic 3 (6%) 1 (2%)
Hyperplasia, Plasma Cell 1 (2%)
Pigmentation 1 (2%)
Spleen (52) (55) (52) (53) (53) (52)
Hematopoietic Cell Proliferation 39 (75%) 43 (78%) 46 (88%) 45 (85%) 41 (77%) 42 (81%)
Hyperplasia, Lymphoid 1 (2%) 1 (2%) 1 (2%)
Necrosis 1 (2%)
Pigmentation 49 (94%) 50 (91%) 51 (98%) 51 (96%) 52 (98%) 52 (100%)
Lymphoid Follicle, Atrophy 5 (9%) 3 (6%) 2 (4%) 5 (9%) 3 (6%)
Red Pulp, Atrophy 4 (8%) 1 (2%) 1 (2%)
Thymus (50) (52) (46) (48) (41) (49)
Atrophy 37 (74%) 34 (65%) 41 (89%) 45 (94%) 36 (88%) 47 (96%)
Fibrosis 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Inflammation 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (52) (55) (53) (53) (53) (52)
Cyst 8 (15%) 3 (5%) 1 (2%) 4 (8%) 5 (9%) 1 (2%)
Fibrosis, Focal 1 (2%)
Hyperplasia 32 (62%) 33 (60%) 30 (57%) 29 (55%) 21 (40%) 23 (44%)
Inflammation, Chronic Active 1 (2%) 2 (4%) 2 (4%)
Inflammation, Granulomatous 2 (4%) 2 (4%) 1 (2%)
Skin (52) (55) (53) (53) (53) (53)
Cyst, Squamous 1 (2%) 1 (2%)
Ulcer 1 (2%)
Dermis, Inflammation, Focal 1 (2%)
Subcutaneous Tissue, Inflammation,
Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (53) (55) (53) (53) (53) (53)
Inflammation, Chronic Active 1 (2%)
Osteopetrosis 1 (2%) 2 (4%)
Cartilage, Hypertrophy, Focal 1 (2%)
Skeletal Muscle (1) (1) (1)
Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (53) (55) (53) (53) (53) (53)
Hemorrhage 1 (2%)
Hydrocephalus 1 (2%) 2 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (53) (55) (53) (53) (53) (51)
Congestion 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 41 (77%) 49 (89%) 45 (85%) 48 (91%) 45 (85%) 49 (96%)
Inflammation, Chronic Active 5 (9%) 3 (5%) 1 (2%) 1 (2%)
Inflammation, Granulomatous 3 (6%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - CONT
Inflammation, Suppurative 1 (2%)
Metaplasia, Squamous 1 (2%) 1 (2%) 2 (4%) 3 (6%) 9 (18%)
Mineralization 1 (2%) 1 (2%) 1 (2%)
Thrombosis 2 (4%) 1 (2%)
Alveolar Epithelium, Hyperplasia 12 (23%) 1 (2%) 1 (2%) 2 (4%)
Alveolar Epithelium, Metaplasia, Bronchiolar 29 (53%) 34 (64%) 41 (77%) 39 (74%) 47 (92%)
Serosa, Fibrosis 2 (4%)
Serosa, Inflammation, Chronic Active 1 (2%)
Serosa, Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%)
Vein, Thrombosis 1 (2%)
Nose (53) (54) (52) (53) (52) (53)
Nasolacrimal Duct, Inflammation 1 (2%) 1 (2%) 1 (2%)
Nasolacrimal Duct, Glands, Hyperplasia 1 (2%)
Nasolacrimal Duct, Respiratory Epithelium,
Hyperplasia 1 (2%)
Nasopharyngeal Duct, Inflammation,
Suppurative 1 (2%) 1 (2%)
Olfactory Epithelium, Inflammation,
Suppurative 1 (2%) 1 (2%)
Respiratory Epithelium, Hyperplasia 2 (4%) 1 (2%) 1 (2%) 2 (4%) 2 (4%)
Respiratory Epithelium, Inflammation,
Suppurative 1 (2%) 1 (2%) 1 (2%)
Respiratory Epithelium, Metaplasia 1 (2%) 1 (2%)
Turbinate, Cyst 1 (2%)
Turbinate, Inflammation, Suppurative 2 (4%) 1 (2%) 1 (2%) 2 (4%)
Trachea (53) (55) (53) (53) (53) (52)
Inflammation 1 (2%)
Peritracheal Tissue, Inflammation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Inflammation 1 (100%)
Eye (51) (55) (53) (53) (53) (52)
Atrophy 1 (2%) 1 (2%)
Cataract 1 (2%) 1 (2%)
Edema 1 (2%)
Anterior Chamber, Inflammation, Suppurative 1 (2%)
Anterior Chamber, Ciliary Body, Cornea,
Inflammation, Suppurative 1 (2%)
Cornea, Inflammation, Suppurative 1 (2%)
Retina, Atrophy 3 (6%) 1 (2%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 30 NG/KG 100 175 300 550
NG/KG NG/KG NG/KG NG/KG
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Retina, Degeneration 1 (2%)
Harderian Gland (53) (53) (53) (53) (53) (52)
Inflammation 2 (4%) 3 (6%) 6 (11%) 6 (11%) 3 (6%) 3 (6%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (53) (55) (53) (53) (53) (52)
Calculus Micro Observation Only 1 (2%) 1 (2%) 1 (2%)
Casts Protein 4 (8%) 3 (5%) 1 (2%) 6 (11%)
Cyst 2 (4%)
Inflammation, Chronic Active 2 (4%) 2 (4%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Inflammation, Suppurative 3 (6%) 1 (2%)
Mineralization 32 (60%) 39 (71%) 44 (83%) 44 (83%) 44 (83%) 39 (75%)
Necrosis 1 (2%) 1 (2%) 1 (2%)
Nephropathy 32 (60%) 29 (53%) 38 (72%) 35 (66%) 38 (72%) 42 (81%)
Papilla, Angiectasis 1 (2%)
Pelvis, Dilatation 2 (4%) 1 (2%) 1 (2%)
Pelvis, Inflammation, Chronic Active 2 (4%) 2 (4%) 2 (4%)
Pelvis, Inflammation, Suppurative 2 (4%) 3 (6%)
Renal Tubule, Accumulation, Hyaline Droplet 1 (2%)
Renal Tubule, Dilatation 1 (2%)
Transitional Epithelium, Hyperplasia 4 (8%) 2 (4%) 8 (15%) 4 (8%) 8 (15%) 8 (15%)
Ureter (1)
Mineralization 1 (100%)
Transitional Epithelium, Hyperplasia 1 (100%)
Urinary Bladder (51) (54) (53) (52) (52) (52)
Edema 1 (2%)
Hemorrhage 1 (2%)
Inflammation 4 (8%) 6 (11%) 10 (19%) 6 (12%) 7 (13%) 4 (8%)
Transitional Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 2 (4%) 1 (2%) 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/
NG/KG KG/STOP
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 98 50
Early Deaths
Natural Death 12 6
Moribund Sacrifice 34 15
Dosing Accident 1
Survivors
Terminal Sacrifice 7 28
Animals Examined Microscopically 53 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (52) (50)
Cyst 1 (2%)
Muscularis, Inflammation 1 (2%)
Intestine Large, Colon (53) (50)
Parasite Metazoan 1 (2%)
Intestine Large, Rectum (53) (50)
Parasite Metazoan 1 (2%) 1 (2%)
Intestine Small, Duodenum (53) (50)
Erosion 2 (4%)
Ulcer 1 (2%)
Epithelium, Hyperplasia 1 (2%)
Intestine Small, Jejunum (53) (50)
Hyperplasia, Lymphoid 1 (2%)
Liver (53) (50)
Angiectasis 2 (4%) 8 (16%)
Basophilic Focus 2 (4%) 7 (14%)
Basophilic Focus, Multiple 3 (6%) 9 (18%)
Cholangiofibrosis 22 (42%) 1 (2%)
Clear Cell Focus 1 (2%)
Clear Cell Focus, Multiple 4 (8%)
Cytoplasmic Alteration 1 (2%)
Degeneration, Cystic 2 (4%) 3 (6%)
Eosinophilic Focus 6 (11%) 3 (6%)
Eosinophilic Focus, Multiple 11 (21%) 9 (18%)
Fatty Change, Diffuse 47 (89%) 12 (24%)
Fatty Change, Focal 11 (22%)
Hepatocyte, Multinucleate 49 (92%) 20 (40%)
Hepatodiaphragmatic Nodule 1 (2%) 1 (2%)
Hyperplasia, Nodular 39 (74%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/
NG/KG KG/STOP
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Inflammation 51 (96%) 46 (92%)
Mixed Cell Focus 4 (8%) 1 (2%)
Mixed Cell Focus, Multiple 5 (9%) 35 (70%)
Multinucleated 1 (2%)
Necrosis 17 (32%) 4 (8%)
Pigmentation 48 (91%) 48 (96%)
Toxic Hepatopathy 49 (92%) 15 (30%)
Bile Duct, Cyst 12 (23%) 5 (10%)
Bile Duct, Fibrosis 5 (9%) 4 (8%)
Bile Duct, Hyperplasia 45 (85%) 16 (32%)
Bile Duct, Inflammation 1 (2%)
Hepatocyte, Degeneration 7 (13%)
Hepatocyte, Hypertrophy 49 (92%) 21 (42%)
Oval Cell, Hyperplasia 40 (75%) 1 (2%)
Portal, Fibrosis 10 (19%)
Serosa, Inflammation 1 (2%)
Mesentery (11)
Inflammation, Chronic Active 3 (27%)
Artery, Inflammation, Chronic Active 7 (64%)
Fat, Necrosis 1 (9%)
Oral Mucosa (11) (6)
Gingival, Cyst, Squamous 1 (9%)
Gingival, Hyperplasia, Squamous 3 (27%) 3 (50%)
Pharyngeal, Hyperplasia, Squamous 1 (17%)
Pancreas (51) (48)
Basophilic Focus 1 (2%)
Cyst 1 (2%)
Inflammation, Chronic Active 13 (25%) 4 (8%)
Necrosis 1 (2%)
Acinus, Atrophy 18 (35%) 7 (15%)
Acinus, Vacuolization Cytoplasmic 23 (45%) 1 (2%)
Artery, Inflammation, Chronic Active 11 (22%) 1 (2%)
Duct, Dilatation 2 (4%)
Duct, Hyperplasia 1 (2%)
Salivary Glands (51) (49)
Atrophy 1 (2%)
Cyst 2 (4%)
Inflammation, Acute 1 (2%)
Stomach, Forestomach (53) (50)
Edema 2 (4%)
Hyperkeratosis 2 (4%)
Hyperplasia, Squamous 8 (15%) 2 (4%)
Mineralization 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/
NG/KG KG/STOP
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Ulcer 2 (4%)
Stomach, Glandular (53) (50)
Erosion 1 (2%)
Inflammation, Chronic Active 1 (2%)
Mineralization 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Glands, Ectasia 1 (2%)
Glands, Hyperplasia 1 (2%)
Tooth (19) (12)
Peridontal Tissue, Fibrosis 1 (5%) 1 (8%)
Peridontal Tissue, Inflammation, Suppurative 18 (95%) 11 (92%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (53) (50)
Aorta, Mineralization 1 (2%)
Heart (51) (50)
Cardiomyopathy 32 (63%) 15 (30%)
Mineralization 1 (2%)
Thrombosis 1 (2%) 1 (2%)
Artery, Inflammation, Chronic Active 1 (2%)
Endocardium, Myocardium, Inflammation, Acute 1 (2%)
Epicardium, Inflammation, Chronic Active 1 (2%)
Epicardium, Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (53) (50)
Angiectasis 1 (2%) 14 (28%)
Atrophy 30 (57%) 9 (18%)
Degeneration, Cystic 10 (19%) 20 (40%)
Hyperplasia 24 (45%) 26 (52%)
Hypertrophy 41 (77%) 42 (84%)
Inflammation, Suppurative 1 (2%)
Mineralization 1 (2%)
Necrosis 2 (4%) 2 (4%)
Vacuolization Cytoplasmic 17 (32%) 6 (12%)
Adrenal Medulla (53) (50)
Hyperplasia 1 (2%) 9 (18%)
Parathyroid Gland (46) (44)
Cyst 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/
NG/KG KG/STOP
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Hyperplasia 2 (5%)
Pituitary Gland (53) (48)
Angiectasis 9 (17%) 14 (29%)
Cyst 1 (2%) 1 (2%)
Cytoplasmic Alteration 1 (2%)
Pars Distalis, Hyperplasia 17 (32%) 17 (35%)
Thyroid Gland (48) (47)
Angiectasis 1 (2%)
Atrophy 1 (2%)
Infiltration Cellular, Lymphocyte 1 (2%)
C-Cell, Hyperplasia 19 (40%) 18 (38%)
Follicular Cell, Hyperplasia 1 (2%)
Follicular Cell, Hypertrophy 16 (33%) 22 (47%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (51) (48)
Inflammation 22 (43%) 32 (67%)
Duct, Cyst 45 (88%) 39 (81%)
Ovary (53) (50)
Atrophy 33 (62%) 47 (94%)
Cyst 11 (21%) 17 (34%)
Oviduct (1) (2)
Inflammation, Suppurative 1 (100%) 2 (100%)
Uterus (53) (50)
Hemorrhage 1 (2%)
Inflammation, Chronic Active 1 (2%)
Inflammation, Suppurative 4 (8%) 11 (22%)
Metaplasia, Squamous 11 (21%) 28 (56%)
Endometrium, Hyperplasia, Cystic 9 (17%) 31 (62%)
Epithelium, Hyperplasia 1 (2%)
Vagina (1)
Cyst 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/
NG/KG KG/STOP
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Bone Marrow (53) (50)
Atrophy 1 (2%)
Hyperplasia 46 (87%) 34 (68%)
Lymph Node (12) (2)
Iliac, Ectasia 1 (50%)
Mediastinal, Angiectasis 1 (8%)
Mediastinal, Ectasia 5 (42%)
Mediastinal, Hemorrhage 6 (50%)
Mediastinal, Hyperplasia, Lymphoid 1 (8%)
Mediastinal, Pigmentation 2 (17%)
Pancreatic, Hemorrhage 1 (8%)
Lymph Node, Mandibular (51) (49)
Atrophy 1 (2%)
Ectasia 3 (6%) 3 (6%)
Hemorrhage 1 (2%)
Hyperplasia, Lymphoid 1 (2%)
Hyperplasia, Plasma Cell 15 (29%) 21 (43%)
Lymph Node, Mesenteric (53) (50)
Atrophy 1 (2%) 2 (4%)
Ectasia 1 (2%)
Hemorrhage 2 (4%)
Hyperplasia, Histiocytic 1 (2%) 1 (2%)
Hyperplasia, Lymphoid 2 (4%)
Hyperplasia, Plasma Cell 1 (2%)
Spleen (52) (50)
Hematopoietic Cell Proliferation 37 (71%) 37 (74%)
Hyperplasia, Lymphoid 3 (6%)
Pigmentation 50 (96%) 50 (100%)
Lymphoid Follicle, Atrophy 6 (12%) 4 (8%)
Red Pulp, Atrophy 2 (4%)
Thymus (44) (43)
Atrophy 41 (93%) 39 (91%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (53) (50)
Cyst 1 (2%) 13 (26%)
Hyperplasia 9 (17%) 22 (44%)
Skin (53) (50)
Cyst, Squamous 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/
NG/KG KG/STOP
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Inflammation, Chronic Active 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (53) (50)
Hemorrhage 1 (2%)
Inflammation, Focal, Suppurative 1 (2%)
Necrosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (51) (50)
Hemorrhage 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 42 (82%) 42 (84%)
Inflammation, Chronic Active 2 (4%)
Metaplasia, Squamous 4 (8%)
Mineralization 1 (2%) 1 (2%)
Alveolar Epithelium, Metaplasia, Bronchiolar 40 (78%) 32 (64%)
Serosa, Inflammation, Suppurative 1 (2%)
Nose (53) (50)
Goblet Cell, Respiratory Epithelium,
Hyperplasia 1 (2%)
Nasolacrimal Duct, Inflammation 1 (2%) 1 (2%)
Nasolacrimal Duct, Respiratory Epithelium,
Hyperplasia 1 (2%)
Nasopharyngeal Duct, Respiratory Epithelium,
Hyperplasia 1 (2%)
Respiratory Epithelium, Hyperplasia 1 (2%) 1 (2%)
Turbinate, Cyst 1 (2%)
Turbinate, Inflammation, Suppurative 4 (8%) 1 (2%)
Vomeronasal Organ, Vacuolization Cytoplasmic 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (52) (50)
Anterior Chamber, Inflammation, Suppurative 1 (2%) 1 (2%)
Cornea, Inflammation, Suppurative 2 (4%) 1 (2%)
Optic Nerve, Degeneration 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 16
NTP Experiment-Test: 96007-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) Date: 10/01/03
Route: GAVAGE Time: 11:41:44
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 1000 1000 NG/
NG/KG KG/STOP
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Retina, Atrophy 4 (8%)
Harderian Gland (52) (50)
Inflammation 6 (12%) 9 (18%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (53) (50)
Casts Protein 2 (4%) 3 (6%)
Inflammation, Suppurative 2 (4%)
Mineralization 37 (70%) 45 (90%)
Necrosis 1 (2%)
Nephropathy 47 (89%) 38 (76%)
Papilla, Necrosis 1 (2%)
Pelvis, Dilatation 2 (4%) 1 (2%)
Pelvis, Hemorrhage 1 (2%)
Pelvis, Inflammation, Chronic Active 1 (2%) 1 (2%)
Pelvis, Metaplasia, Squamous 1 (2%)
Transitional Epithelium, Hyperplasia 11 (21%) 2 (4%)
Ureter (3)
Inflammation 1 (33%)
Metaplasia, Squamous 2 (67%)
Mineralization 2 (67%)
Transitional Epithelium, Hyperplasia 3 (100%)
Urinary Bladder (53) (50)
Inflammation 6 (11%) 3 (6%)
Metaplasia, Squamous 1 (2%)
Transitional Epithelium, Hyperplasia 2 (4%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 17
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