TDMS Study 05094-02 Pathology Tables
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
Facility: Southern Research Institute
Chemical CAS #: 85-68-7
Lock Date: 11/25/92
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: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD CONTROL 0.6% 1.2% 2.4%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60 60
Scheduled Sacrifice 10 10 10 10 10
Early Deaths
Moribund Sacrifice 23 7 17 16 20
Natural Death 2 2 4 5 1
Survivors
Terminal Sacrifice 25 41 29 29 29
Animals Examined Microscopically 60 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (60) (59) (58) (59) (60)
Parasite Metazoan 3 (5%) 2 (3%) 2 (3%) 3 (5%) 4 (7%)
Intestine Large, Rectum (60) (58) (60) (60) (60)
Parasite Metazoan 3 (5%) 6 (10%) 5 (8%) 11 (18%) 4 (7%)
Intestine Large, Cecum (59) (60) (60) (59) (59)
Edema 2 (3%) 2 (3%) 1 (2%)
Parasite Metazoan 2 (3%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Ulcer 1 (2%)
Intestine Small, Ileum (59) (59) (60) (60) (60)
Inflammation, Chronic 1 (2%)
Ulcer 1 (2%)
Liver (60) (60) (60) (60) (60)
Angiectasis 1 (2%) 4 (7%)
Basophilic Focus 47 (78%) 47 (78%) 48 (80%) 49 (82%) 48 (80%)
Clear Cell Focus 3 (5%) 2 (3%) 3 (5%) 8 (13%) 9 (15%)
Cyst 1 (2%) 2 (3%) 2 (3%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 19 (32%) 17 (28%) 16 (27%) 10 (17%) 20 (33%)
Granuloma 7 (12%) 6 (10%) 14 (23%) 9 (15%) 2 (3%)
Hematopoietic Cell Proliferation 1 (2%) 2 (3%) 1 (2%)
Hepatodiaphragmatic Nodule 10 (17%) 7 (12%) 7 (12%) 8 (13%) 12 (20%)
Inflammation, Subacute 3 (5%) 1 (2%)
Mixed Cell Focus 10 (17%) 4 (7%) 4 (7%) 5 (8%) 6 (10%)
Thrombosis 1 (2%)
Bile Duct, Hyperplasia 11 (18%) 10 (17%) 12 (20%) 12 (20%) 9 (15%)
Centrilobular, Necrosis 1 (2%) 2 (3%) 1 (2%)
Hepatocyte, Hyperplasia, Focal 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 7 (12%) 1 (2%) 6 (10%) 2 (3%)
Kupffer Cell, Hyperplasia 1 (2%) 1 (2%)
Kupffer Cell, Pigmentation 4 (7%) 4 (7%) 1 (2%) 6 (10%) 10 (17%)
Lobules, Necrosis 6 (10%) 1 (2%) 3 (5%) 6 (10%)
Mesentery (11) (2) (8) (12) (6)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD CONTROL 0.6% 1.2% 2.4%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Accessory Spleen 1 (9%) 2 (17%) 1 (17%)
Fat, Necrosis 10 (91%) 2 (100%) 7 (88%) 9 (75%) 6 (100%)
Oral Mucosa (1) (1) (1)
Hyperplasia 1 (100%)
Pancreas (60) (59) (60) (60) (60)
Atrophy 19 (32%) 18 (31%) 20 (33%) 16 (27%) 12 (20%)
Cyst 1 (2%)
Edema 1 (2%)
Acinus, Cytoplasmic Alteration 1 (2%) 2 (3%) 1 (2%) 1 (2%)
Acinus, Hyperplasia, Focal 1 (2%) 4 (7%) 2 (3%)
Salivary Glands (59) (60) (60) (60) (60)
Atrophy 1 (2%) 2 (3%)
Hyperplasia 1 (2%)
Stomach, Forestomach (60) (60) (60) (60) (60)
Edema 2 (3%) 1 (2%) 1 (2%)
Ulcer 1 (2%) 1 (2%) 1 (2%)
Mucosa, Hyperplasia 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Stomach, Glandular (60) (60) (60) (60) (60)
Edema 1 (2%)
Erosion 1 (2%) 2 (3%)
Hyperplasia 1 (2%)
Inflammation, Chronic 1 (2%)
Mineralization 1 (2%)
Ulcer 3 (5%) 1 (2%) 1 (2%)
Tongue (3) (1) (1) (1)
Epithelium, Hyperplasia 1 (33%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (60) (60) (60) (60)
Cardiomyopathy 17 (28%) 14 (23%) 22 (37%) 24 (40%) 13 (22%)
Mineralization 1 (2%)
Thrombosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 7 (12%) 10 (17%) 7 (12%) 10 (17%) 10 (17%)
Angiectasis 27 (45%) 16 (27%) 29 (48%) 33 (55%) 32 (53%)
Cyst 2 (3%)
Degeneration, Fatty 11 (18%) 4 (7%) 16 (27%) 11 (18%) 4 (7%)
Hemorrhage 1 (2%) 1 (2%)
Hyperplasia, Focal 9 (15%) 10 (17%) 4 (7%) 2 (3%) 3 (5%)
Hypertrophy, Focal 10 (17%) 3 (5%) 12 (20%) 9 (15%)
Metaplasia, Osseous 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD CONTROL 0.6% 1.2% 2.4%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Necrosis 1 (2%)
Adrenal Medulla (59) (60) (59) (60) (60)
Hyperplasia 1 (2%) 3 (5%) 2 (3%) 4 (7%) 1 (2%)
Islets, Pancreatic (60) (59) (60) (60) (60)
Hyperplasia 1 (2%)
Metaplasia, Hepatocyte 1 (2%)
Parathyroid Gland (56) (56) (59) (59) (58)
Cyst 1 (2%)
Hyperplasia 1 (2%)
Pituitary Gland (59) (57) (60) (58) (60)
Pars Distalis, Angiectasis 8 (14%) 8 (14%) 9 (15%) 9 (16%) 7 (12%)
Pars Distalis, Cyst 30 (51%) 10 (18%) 30 (50%) 24 (41%) 20 (33%)
Pars Distalis, Hemorrhage 1 (2%)
Pars Distalis, Hyperplasia 1 (2%)
Pars Distalis, Hyperplasia, Focal 13 (22%) 14 (25%) 13 (22%) 9 (16%) 12 (20%)
Pars Intermedia, Angiectasis 3 (5%) 3 (5%)
Pars Intermedia, Cyst 2 (4%) 3 (5%)
Pars Intermedia, Hyperplasia 1 (2%) 1 (2%)
Thyroid Gland (59) (60) (60) (60) (60)
Ultimobranchial Cyst 3 (5%) 4 (7%) 1 (2%)
C-Cell, Hyperplasia 6 (10%) 4 (7%) 7 (12%) 8 (13%) 3 (5%)
Follicle, Cyst 1 (2%) 1 (2%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (1)
Hemorrhage 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (60) (60) (60) (60) (60)
Ectasia 12 (20%) 4 (7%) 21 (35%) 13 (22%) 11 (18%)
Hyperplasia 1 (2%) 1 (2%) 4 (7%) 2 (3%) 1 (2%)
Inflammation, Chronic 6 (10%) 3 (5%) 6 (10%) 4 (7%) 1 (2%)
Inflammation, Suppurative 3 (5%) 4 (7%) 5 (8%) 6 (10%) 3 (5%)
Ovary (60) (60) (60) (60) (60)
Cyst 3 (5%) 5 (8%) 6 (10%) 6 (10%)
Inflammation, Chronic 1 (2%) 1 (2%)
Uterus (60) (60) (60) (60) (60)
Cyst 1 (2%)
Hydrometra 4 (7%) 5 (8%) 4 (7%) 5 (8%) 5 (8%)
Hyperplasia, Cystic 4 (7%) 4 (7%) 4 (7%) 1 (2%) 12 (20%)
Inflammation, Suppurative 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD CONTROL 0.6% 1.2% 2.4%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60) (60)
Hypercellularity 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Myelofibrosis 4 (7%) 3 (5%) 3 (5%) 6 (10%) 6 (10%)
Lymph Node (12) (13) (12) (17) (16)
Iliac, Hyperplasia, Lymphoid 1 (8%)
Iliac, Pigmentation 1 (8%)
Mediastinal, Hemorrhage 1 (8%) 3 (23%) 2 (17%) 2 (12%) 2 (13%)
Mediastinal, Hyperplasia, Lymphoid 1 (8%)
Mediastinal, Pigmentation 2 (17%) 6 (46%) 6 (50%) 10 (59%) 10 (63%)
Pancreatic, Hemorrhage 1 (6%)
Pancreatic, Pigmentation 1 (8%) 2 (17%) 3 (18%) 3 (19%)
Renal, Hemorrhage 1 (8%) 2 (17%) 2 (12%)
Renal, Hyperplasia, Lymphoid 1 (8%)
Renal, Pigmentation 1 (8%) 4 (31%) 5 (42%) 3 (18%) 4 (25%)
Lymph Node, Mandibular (59) (60) (60) (60) (60)
Ectasia 2 (3%) 2 (3%) 5 (8%) 4 (7%) 5 (8%)
Hemorrhage 5 (8%) 8 (13%) 9 (15%) 3 (5%) 6 (10%)
Hyperplasia, Lymphoid 8 (14%) 3 (5%) 7 (12%) 4 (7%)
Pigmentation 15 (25%) 21 (35%) 27 (45%) 17 (28%) 20 (33%)
Lymph Node, Mesenteric (60) (60) (60) (60) (60)
Ectasia 1 (2%)
Hemorrhage 3 (5%) 2 (3%) 3 (5%) 3 (5%) 2 (3%)
Hyperplasia, Lymphoid 1 (2%) 2 (3%) 2 (3%) 1 (2%)
Spleen (60) (60) (60) (60) (60)
Developmental Malformation 1 (2%)
Fibrosis 1 (2%) 3 (5%) 2 (3%) 3 (5%) 1 (2%)
Hematopoietic Cell Proliferation 11 (18%) 5 (8%) 15 (25%) 11 (18%) 17 (28%)
Hemorrhage 1 (2%) 1 (2%)
Necrosis 1 (2%)
Pigmentation, Hemosiderin 29 (48%) 23 (38%) 30 (50%) 31 (52%) 39 (65%)
Thymus (58) (59) (59) (60) (58)
Cyst 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (59) (58) (60) (60) (60)
Ectasia 12 (20%) 5 (9%) 9 (15%) 20 (33%) 11 (18%)
Hyperplasia 33 (56%) 9 (16%) 41 (68%) 25 (42%) 18 (30%)
Inflammation, Chronic Active 1 (2%)
Skin (60) (60) (60) (60) (60)
Acanthosis 1 (2%) 2 (3%) 1 (2%)
Cyst Epithelial Inclusion 1 (2%) 1 (2%) 1 (2%)
Developmental Malformation 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD CONTROL 0.6% 1.2% 2.4%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Hemorrhage 2 (3%)
Hyperkeratosis 3 (5%) 4 (7%) 2 (3%) 3 (5%)
Inflammation, Chronic 1 (2%)
Ulcer 2 (3%) 1 (2%) 4 (7%) 2 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60) (60)
Cranium, Hyperostosis 1 (2%)
Cranium, Osteopetrosis 7 (12%) 3 (5%) 11 (18%) 10 (17%) 7 (12%)
Femur, Osteopetrosis 5 (8%) 4 (7%) 7 (12%) 7 (12%) 5 (8%)
Femur, Osteosclerosis 1 (2%)
Rib, Osteopetrosis 1 (2%) 1 (2%)
Skeletal Muscle (1) (1)
Hemorrhage 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60) (60)
Compression 9 (15%) 1 (2%) 6 (10%) 9 (15%) 8 (13%)
Gliosis 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hydrocephalus 2 (3%) 1 (2%) 3 (5%) 1 (2%)
Necrosis 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60) (60)
Congestion 1 (2%) 1 (2%)
Edema 1 (2%)
Hemorrhage 1 (2%) 2 (3%) 1 (2%)
Infiltration Cellular, Histiocyte 23 (38%) 20 (33%) 23 (38%) 21 (35%) 21 (35%)
Inflammation, Subacute 1 (2%) 2 (3%) 1 (2%)
Alveolar Epithelium, Hyperplasia 2 (3%) 1 (2%) 4 (7%) 2 (3%)
Nose (60) (60) (60) (60) (60)
Exudate 7 (12%) 3 (5%) 4 (7%) 2 (3%) 4 (7%)
Foreign Body 5 (8%) 1 (2%) 4 (7%) 1 (2%)
Fungus 4 (7%) 2 (3%) 1 (2%) 1 (2%)
Mucosa, Hyperplasia 3 (5%) 3 (5%) 2 (3%) 2 (3%) 1 (2%)
Mucosa, Metaplasia, Squamous 4 (7%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD CONTROL 0.6% 1.2% 2.4%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (2) (2) (1) (3)
Atrophy 1 (50%)
Cataract 2 (100%) 2 (67%)
Hemorrhage 1 (50%) 1 (33%)
Retina, Degeneration 2 (100%) 2 (67%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60) (60)
Calculus Micro Observation Only 1 (2%)
Cyst 1 (2%) 1 (2%) 2 (3%) 2 (3%) 2 (3%)
Hydronephrosis 2 (3%) 1 (2%) 1 (2%)
Mineralization 53 (88%) 58 (97%) 43 (72%) 46 (77%) 43 (72%)
Nephropathy 41 (68%) 34 (57%) 57 (95%) 53 (88%) 55 (92%)
Renal Tubule, Atrophy 1 (2%) 1 (2%) 3 (5%) 2 (3%)
Renal Tubule, Cytoplasmic Alteration 1 (2%)
Renal Tubule, Dilatation 1 (2%) 2 (3%) 1 (2%)
Renal Tubule, Necrosis 1 (2%) 1 (2%)
Renal Tubule, Pigmentation 59 (98%) 57 (95%) 59 (98%) 59 (98%) 57 (95%)
Transitional Epithelium, Hyperplasia 4 (7%) 3 (5%) 7 (12%) 4 (7%)
Ureter (1) (1)
Dilatation 1 (100%)
Transitional Epithelium, Hyperplasia 1 (100%)
Urinary Bladder (60) (60) (60) (60) (60)
Edema 1 (2%) 1 (2%)
Hemorrhage 1 (2%)
Transitional Epithelium, Hyperplasia 4 (7%) 1 (2%) 10 (17%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD CONTROL 0.3% 0.6% 1.2%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60 60 60
Scheduled Sacrifice 10 10 10 10 10
Early Deaths
Moribund Sacrifice 19 15 19 26 26
Natural Death 3 1 11 2 2
Survivors
Terminal Sacrifice 28 33 20 22 22
Other 1
Animals Examined Microscopically 60 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (54) (59) (58) (59) (58)
Dilatation 1 (2%)
Parasite Metazoan 6 (11%) 6 (10%) 3 (5%) 5 (8%) 4 (7%)
Intestine Large, Rectum (59) (57) (60) (60) (59)
Parasite Metazoan 12 (20%) 8 (14%) 5 (8%) 3 (5%) 9 (15%)
Intestine Large, Cecum (57) (60) (60) (60) (60)
Edema 4 (7%) 2 (3%) 4 (7%)
Parasite Metazoan 2 (3%) 1 (2%)
Ulcer 1 (2%) 1 (2%)
Intestine Small, Duodenum (60) (60) (60) (60) (60)
Erosion 1 (2%)
Intestine Small, Ileum (59) (60) (60) (59) (60)
Parasite Metazoan 1 (2%)
Liver (60) (60) (60) (60) (60)
Angiectasis 1 (2%) 4 (7%) 2 (3%) 5 (8%) 2 (3%)
Basophilic Focus 28 (47%) 22 (37%) 24 (40%) 20 (33%) 15 (25%)
Clear Cell Focus 17 (28%) 9 (15%) 10 (17%) 8 (13%) 9 (15%)
Cyst 2 (3%)
Degeneration, Cystic 7 (12%) 7 (12%) 7 (12%) 10 (17%) 6 (10%)
Developmental Malformation 1 (2%)
Eosinophilic Focus 6 (10%) 10 (17%) 9 (15%) 8 (13%) 6 (10%)
Granuloma 1 (2%) 1 (2%) 8 (13%)
Hematopoietic Cell Proliferation 1 (2%) 2 (3%)
Hemorrhage 2 (3%)
Hepatodiaphragmatic Nodule 4 (7%) 4 (7%) 4 (7%) 1 (2%) 8 (13%)
Inflammation, Subacute 1 (2%) 1 (2%) 3 (5%) 5 (8%)
Mixed Cell Focus 6 (10%) 7 (12%) 5 (8%) 8 (13%) 7 (12%)
Bile Duct, Hyperplasia 44 (73%) 39 (65%) 45 (75%) 42 (70%) 27 (45%)
Centrilobular, Necrosis 1 (2%) 4 (7%) 2 (3%)
Hepatocyte, Hyperplasia, Focal 1 (2%)
Hepatocyte, Vacuolization Cytoplasmic 8 (13%) 12 (20%) 2 (3%) 3 (5%) 4 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD CONTROL 0.3% 0.6% 1.2%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Kupffer Cell, Pigmentation 2 (3%) 1 (2%) 6 (10%) 6 (10%)
Lobules, Necrosis 2 (3%) 2 (3%) 2 (3%) 3 (5%)
Mesentery (11) (15) (15) (17) (6)
Accessory Spleen 2 (13%) 3 (20%) 2 (33%)
Angiectasis 1 (9%)
Fibrosis 1 (9%) 1 (6%)
Hemorrhage 1 (6%)
Fat, Necrosis 9 (82%) 11 (73%) 10 (67%) 11 (65%) 3 (50%)
Pancreas (60) (60) (59) (60) (60)
Atrophy 32 (53%) 37 (62%) 37 (63%) 32 (53%) 33 (55%)
Cytoplasmic Alteration 1 (2%) 1 (2%)
Edema 3 (5%)
Acinus, Cytoplasmic Alteration 1 (2%) 1 (2%) 1 (2%)
Acinus, Hyperplasia, Focal 4 (7%) 2 (3%) 7 (12%) 9 (15%) 12 (20%)
Salivary Glands (60) (60) (60) (60) (60)
Cytoplasmic Alteration 1 (2%)
Stomach, Forestomach (60) (60) (60) (60) (60)
Edema 1 (2%) 4 (7%) 3 (5%)
Ulcer 2 (3%) 1 (2%) 1 (2%) 6 (10%) 3 (5%)
Mucosa, Hyperplasia 2 (3%) 1 (2%) 3 (5%) 1 (2%)
Stomach, Glandular (60) (60) (60) (60) (60)
Edema 2 (3%) 1 (2%) 3 (5%)
Erosion 2 (3%) 5 (8%) 2 (3%) 1 (2%)
Ulcer 2 (3%) 1 (2%) 1 (2%) 1 (2%)
Mucosa, Hyperplasia 1 (2%)
Tongue (1) (1) (1)
Epithelium, Hyperplasia 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (60) (60) (60) (60)
Hypertrophy 2 (3%) 2 (3%) 1 (2%)
Inflammation, Subacute 2 (3%) 2 (3%) 1 (2%)
Thrombosis 1 (2%)
Heart (60) (60) (60) (60) (60)
Cardiomyopathy 40 (67%) 29 (48%) 36 (60%) 30 (50%) 40 (67%)
Inflammation, Chronic 1 (2%)
Thrombosis 2 (3%) 3 (5%) 1 (2%) 5 (8%)
Schwann Cell, Hyperplasia 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD CONTROL 0.3% 0.6% 1.2%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60) (60)
Accessory Adrenal Cortical Nodule 15 (25%) 13 (22%) 12 (20%) 10 (17%) 9 (15%)
Angiectasis 8 (13%) 1 (2%) 3 (5%) 2 (3%)
Degeneration, Fatty 3 (5%) 4 (7%) 5 (8%) 6 (10%) 8 (13%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%)
Hyperplasia, Focal 8 (13%) 9 (15%) 6 (10%) 11 (18%) 4 (7%)
Hypertrophy 1 (2%)
Hypertrophy, Focal 2 (3%) 3 (5%) 2 (3%) 5 (8%) 2 (3%)
Vacuolization Cytoplasmic 1 (2%)
Adrenal Medulla (60) (60) (60) (60) (60)
Hyperplasia 6 (10%) 6 (10%) 12 (20%) 17 (28%) 12 (20%)
Islets, Pancreatic (60) (60) (59) (60) (60)
Hyperplasia 3 (5%) 2 (3%) 2 (3%)
Metaplasia, Hepatocyte 1 (2%)
Parathyroid Gland (58) (56) (59) (59) (59)
Hyperplasia 1 (2%) 1 (2%)
Pituitary Gland (59) (60) (60) (60) (59)
Pars Distalis, Angiectasis 3 (5%) 4 (7%) 1 (2%) 3 (5%)
Pars Distalis, Cyst 4 (7%) 4 (7%) 5 (8%) 7 (12%) 3 (5%)
Pars Distalis, Hemorrhage 1 (2%)
Pars Distalis, Hyperplasia 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Pars Distalis, Hyperplasia, Focal 10 (17%) 12 (20%) 12 (20%) 11 (18%) 7 (12%)
Pars Distalis, Necrosis 1 (2%)
Pars Intermedia, Angiectasis 3 (5%) 2 (3%) 2 (3%)
Pars Intermedia, Cyst 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Pars Intermedia, Hyperplasia 2 (3%) 1 (2%) 1 (2%)
Thyroid Gland (60) (60) (60) (60) (60)
Hyperplasia 1 (2%)
Ultimobranchial Cyst 2 (3%) 2 (3%) 2 (3%) 2 (3%) 4 (7%)
C-Cell, Hyperplasia 4 (7%) 12 (20%) 10 (17%) 13 (22%) 7 (12%)
Follicle, Cyst 2 (3%) 2 (3%) 1 (2%) 5 (8%)
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (60) (60) (60)
Atypia Cellular 29 (48%) 33 (55%) 28 (47%) 30 (50%) 39 (65%)
Hypospermia 34 (57%) 41 (68%) 37 (62%) 41 (68%) 43 (72%)
Preputial Gland (60) (60) (60) (60) (60)
Ectasia 11 (18%) 9 (15%) 14 (23%) 20 (33%) 14 (23%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD CONTROL 0.3% 0.6% 1.2%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Hyperplasia 1 (2%) 2 (3%) 2 (3%) 2 (3%) 1 (2%)
Inflammation, Chronic 31 (52%) 28 (47%) 23 (38%) 25 (42%) 23 (38%)
Inflammation, Suppurative 11 (18%) 5 (8%) 9 (15%) 15 (25%) 7 (12%)
Prostate (60) (60) (60) (60) (60)
Corpora Amylacea 18 (30%) 26 (43%) 30 (50%) 37 (62%) 37 (62%)
Fibrosis 1 (2%)
Hemorrhage 1 (2%)
Inflammation, Suppurative 34 (57%) 34 (57%) 34 (57%) 32 (53%) 23 (38%)
Epithelium, Hyperplasia 5 (8%) 5 (8%) 6 (10%) 6 (10%) 3 (5%)
Seminal Vesicle (60) (60) (60) (60) (60)
Dilatation 4 (7%) 2 (3%) 1 (2%)
Testes (60) (60) (60) (60) (60)
Mineralization 1 (2%)
Interstitial Cell, Hyperplasia 9 (15%) 9 (15%) 13 (22%) 12 (20%) 10 (17%)
Seminiferous Tubule, Atrophy 2 (3%) 2 (3%) 5 (8%) 6 (10%) 4 (7%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60) (60)
Hypercellularity 1 (2%) 2 (3%) 4 (7%) 1 (2%)
Myelofibrosis 2 (3%) 3 (5%) 4 (7%) 4 (7%) 5 (8%)
Lymph Node (25) (14) (22) (32) (20)
Deep Cervical, Hemorrhage 1 (4%)
Deep Cervical, Pigmentation 1 (4%)
Iliac, Hemorrhage 1 (4%)
Iliac, Hyperplasia, Lymphoid 1 (4%)
Iliac, Pigmentation 1 (4%)
Mediastinal, Fibrosis 1 (3%)
Mediastinal, Hemorrhage 7 (28%) 4 (29%) 5 (23%) 2 (6%) 1 (5%)
Mediastinal, Hyperplasia, Lymphoid 1 (7%)
Mediastinal, Pigmentation 7 (28%) 4 (29%) 7 (32%) 12 (38%) 6 (30%)
Pancreatic, Ectasia 1 (3%)
Pancreatic, Hemorrhage 1 (5%) 1 (5%)
Pancreatic, Hyperplasia, Lymphoid 1 (7%) 1 (3%)
Pancreatic, Pigmentation 1 (7%) 4 (13%) 2 (10%)
Renal, Hyperplasia, Lymphoid 1 (4%)
Renal, Pigmentation 2 (8%) 2 (9%) 3 (9%) 2 (10%)
Lymph Node, Mandibular (59) (58) (59) (60) (60)
Congestion 1 (2%) 2 (3%)
Ectasia 6 (10%) 5 (9%) 4 (7%) 5 (8%) 4 (7%)
Hemorrhage 6 (10%) 10 (17%) 3 (5%) 3 (5%) 6 (10%)
Hyperplasia, Lymphoid 4 (7%) 6 (10%) 3 (5%) 1 (2%) 5 (8%)
Pigmentation 2 (3%) 7 (12%) 5 (8%) 1 (2%)
Lymph Node, Mesenteric (60) (60) (60) (60) (60)
Ectasia 7 (12%) 1 (2%) 4 (7%) 2 (3%) 1 (2%)
Hemorrhage 1 (2%) 3 (5%) 3 (5%) 2 (3%) 4 (7%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD CONTROL 0.3% 0.6% 1.2%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - CONT
Hyperplasia, Lymphoid 2 (3%) 3 (5%) 1 (2%)
Spleen (60) (60) (60) (60) (60)
Developmental Malformation 1 (2%)
Fibrosis 5 (8%) 7 (12%) 11 (18%) 14 (23%) 10 (17%)
Granuloma 1 (2%)
Hematopoietic Cell Proliferation 4 (7%) 6 (10%) 8 (13%) 5 (8%) 8 (13%)
Hemorrhage 1 (2%)
Metaplasia, Osseous 1 (2%)
Necrosis 1 (2%) 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 24 (40%) 11 (18%) 11 (18%) 12 (20%) 13 (22%)
Lymphoid Follicle, Atrophy 1 (2%)
Thymus (59) (58) (58) (60) (57)
Cyst 1 (2%) 1 (2%)
Hemorrhage 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (55) (58) (58) (57) (58)
Hyperplasia 10 (18%) 8 (14%) 16 (28%) 10 (18%) 12 (21%)
Skin (60) (60) (60) (60) (60)
Acanthosis 1 (2%) 2 (3%) 2 (3%) 10 (17%)
Cyst Epithelial Inclusion 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Edema 1 (2%)
Hemorrhage 1 (2%)
Hyperkeratosis 1 (2%) 2 (3%) 3 (5%) 13 (22%)
Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) 2 (3%)
Inflammation, Chronic, Focal 1 (2%)
Metaplasia, Osseous 1 (2%)
Ulcer 1 (2%) 3 (5%)
Subcutaneous Tissue, Inflammation, Chronic 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60) (60)
Cranium, Hyperostosis 1 (2%)
Cranium, Osteopetrosis 1 (2%) 1 (2%) 1 (2%)
Femur, Osteopetrosis 1 (2%) 2 (3%) 3 (5%) 1 (2%)
Rib, Osteopetrosis 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD CONTROL 0.3% 0.6% 1.2%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60) (60)
Compression 4 (7%) 4 (7%) 5 (8%) 2 (3%)
Gliosis 1 (2%)
Hemorrhage 2 (3%)
Hydrocephalus 2 (3%) 2 (3%) 1 (2%) 1 (2%)
Mineralization 1 (2%) 1 (2%)
Necrosis 1 (2%) 2 (3%)
Cerebellum, Necrosis 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60) (60)
Congestion 1 (2%) 1 (2%) 2 (3%) 1 (2%)
Foreign Body 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 15 (25%) 16 (27%) 12 (20%) 14 (23%) 8 (13%)
Inflammation, Subacute 1 (2%) 1 (2%) 3 (5%) 1 (2%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Metaplasia, Osseous 1 (2%) 1 (2%)
Alveolar Epithelium, Hyperplasia 8 (13%) 6 (10%) 2 (3%) 7 (12%) 3 (5%)
Nose (60) (60) (60) (60) (60)
Exudate 17 (28%) 14 (23%) 12 (20%) 14 (23%) 17 (28%)
Foreign Body 8 (13%) 4 (7%) 6 (10%) 7 (12%) 5 (8%)
Fungus 12 (20%) 12 (20%) 6 (10%) 8 (13%) 11 (18%)
Mucosa, Hyperplasia 11 (18%) 9 (15%) 8 (13%) 6 (10%) 12 (20%)
Mucosa, Metaplasia, Squamous 9 (15%) 7 (12%) 6 (10%) 7 (12%) 2 (3%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (2)
Atrophy 1 (100%)
Cataract 1 (50%)
Hemorrhage 1 (50%)
Retina, Degeneration 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60) (60)
Cyst 2 (3%) 3 (5%)
Inflammation, Suppurative 1 (2%) 3 (5%) 9 (15%) 4 (7%)
Mineralization 1 (2%) 1 (2%) 2 (3%)
Nephropathy 58 (97%) 57 (95%) 57 (95%) 60 (100%) 57 (95%)
Papilla, Inflammation, Suppurative 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05094-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 06:28:06
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD CONTROL 0.3% 0.6% 1.2%
CONTROL FEED RTD
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Papilla, Necrosis 1 (2%)
Renal Tubule, Atrophy 1 (2%) 1 (2%)
Renal Tubule, Cytoplasmic Alteration 2 (3%) 1 (2%)
Renal Tubule, Dilatation 1 (2%) 1 (2%)
Renal Tubule, Hyaline Droplet 1 (2%)
Renal Tubule, Hyperplasia 2 (3%)
Renal Tubule, Necrosis 1 (2%)
Renal Tubule, Pigmentation 59 (98%) 59 (98%) 58 (97%) 60 (100%) 60 (100%)
Transitional Epithelium, Hyperplasia 6 (10%) 10 (17%) 6 (10%) 1 (2%)
Urinary Bladder (60) (60) (60) (60) (60)
Hemorrhage 1 (2%)
Inflammation, Suppurative 2 (3%)
Transitional Epithelium, Hyperplasia 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
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