TDMS Study 05106-01 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
DIETHYLPHTHALATE
NTP Experiment-Test: 05106-01 Report: PEIRPT03
Study Type: CHRONIC Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
Facility: Hazleton, Maryland
Chemical CAS #: 84-66-2
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: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0UL/RAT 100UL 300UL
UF RAT LF RAT HF
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60
Scheduled Sacrifice 9 10 10
Early Deaths
Moribund Sacrifice 12 12 17
Natural Death 9 10 10
Survivors
Terminal Sacrifice 30 28 21
Natural Death 2
Animals Examined Microscopically 60 52 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (59) (49) (60)
Hyperkeratosis 1 (2%) 3 (6%)
Intestine Large, Cecum (57) (45) (56)
Ulcer 1 (2%)
Intestine Large, Colon (58) (47) (58)
Edema 2 (4%) 2 (3%)
Parasite Metazoan 1 (2%) 3 (6%) 2 (3%)
Intestine Small, Duodenum (58) (49) (58)
Ulcer 1 (2%)
Mucosa, Erosion, Focal 1 (2%)
Intestine Small, Ileum (55) (44) (53)
Mucosa, Atrophy 1 (2%)
Intestine Small, Jejunum (55) (46) (56)
Mucosa, Atrophy 1 (2%)
Liver (59) (52) (60)
Angiectasis 1 (2%) 4 (8%) 1 (2%)
Basophilic Focus 16 (27%) 11 (21%) 6 (10%)
Clear Cell Focus 2 (3%) 3 (6%) 3 (5%)
Congestion 1 (2%)
Degeneration, Fatty 14 (24%) 5 (10%) 1 (2%)
Eosinophilic Focus 1 (2%)
Hematopoietic Cell Proliferation 1 (2%)
Hepatodiaphragmatic Nodule 8 (14%) 10 (19%) 3 (5%)
Infiltration Cellular, Focal, Histiocyte 1 (2%)
Inflammation, Chronic, Focal 25 (42%) 24 (46%) 27 (45%)
Inflammation, Focal, Granulomatous 5 (8%) 1 (2%) 2 (3%)
Mitotic Alteration 1 (2%)
Mixed Cell Focus 1 (2%) 2 (3%)
Necrosis 2 (3%) 3 (6%) 2 (3%)
Necrosis, Focal 1 (2%)
Pigmentation, Focal 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 2
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0UL/RAT 100UL 300UL
UF RAT LF RAT HF
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Bile Duct, Hyperplasia 33 (56%) 28 (54%) 35 (58%)
Centrilobular, Degeneration, Fatty 3 (5%)
Hepatocyte, Hyperplasia 1 (2%)
Midzonal, Degeneration, Fatty 3 (5%) 1 (2%)
Peripheral, Degeneration, Fatty 3 (5%) 5 (10%) 2 (3%)
Periportal, Infiltration Cellular, Mixed Cell 1 (2%)
Subserosa, Angiectasis 1 (2%)
Mesentery (3) (3) (1)
Hemorrhage 1 (33%)
Polyarteritis 1 (100%)
Fat, Granuloma 2 (67%) 1 (33%)
Pancreas (59) (50) (60)
Cytoplasmic Alteration, Focal 1 (2%) 2 (3%)
Edema 1 (2%)
Fibrosis 1 (2%)
Fibrosis, Focal 1 (2%)
Inflammation, Focal 1 (2%)
Acinus, Atrophy 10 (17%) 16 (32%) 16 (27%)
Stomach, Forestomach (59) (50) (60)
Acanthosis 16 (27%) 13 (26%) 11 (18%)
Cyst Epithelial Inclusion 1 (2%)
Edema 6 (10%) 4 (8%) 6 (10%)
Hemorrhage 2 (3%) 1 (2%)
Hyperkeratosis 14 (24%) 11 (22%) 8 (13%)
Ulcer 7 (12%) 4 (8%) 4 (7%)
Serosa, Inflammation, Proliferative 1 (2%)
Stomach, Glandular (59) (50) (60)
Ulcer 1 (2%) 2 (3%)
Mucosa, Erosion, Focal 1 (2%) 1 (2%) 2 (3%)
Tooth (1)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (2)
Polyarteritis 1 (50%)
Heart (59) (51) (60)
Abscess 1 (2%)
Cardiomyopathy 47 (80%) 34 (67%) 38 (63%)
Atrium, Thrombosis 2 (4%) 3 (5%)
Myocardium, Mineralization, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 3
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0UL/RAT 100UL 300UL
UF RAT LF RAT HF
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (60) (50) (60)
Angiectasis 1 (2%)
Degeneration, Fatty, Focal 15 (25%) 8 (16%) 9 (15%)
Hematopoietic Cell Proliferation 1 (2%)
Hyperplasia, Focal 13 (22%) 12 (24%) 8 (13%)
Hypertrophy, Focal 1 (2%)
Thrombosis 1 (2%)
Adrenal Gland, Medulla (58) (50) (60)
Hyperplasia, Focal 1 (2%) 3 (6%) 5 (8%)
Islets, Pancreatic (50) (50) (50)
Cytomegaly 1 (2%)
Hyperplasia 2 (4%)
Parathyroid Gland (54) (50) (57)
Hypertrophy 7 (13%) 4 (8%) 2 (4%)
Pituitary Gland (59) (50) (58)
Angiectasis 4 (7%) 6 (12%) 3 (5%)
Hemorrhage 1 (2%) 1 (2%)
Pars Distalis, Cyst 1 (2%)
Pars Distalis, Hyperplasia, Focal 7 (12%) 7 (14%) 9 (16%)
Thyroid Gland (59) (50) (60)
Ultimobranchial Cyst 1 (2%)
C-Cell, Hyperplasia 8 (14%) 6 (12%) 6 (10%)
Follicle, Dilatation 3 (6%) 4 (7%)
Follicular Cell, Hyperplasia 2 (3%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (2) (2) (2)
Abscess 1 (50%) 1 (50%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (53) (39) (50)
Cyst 1 (3%)
Ectasia 6 (11%) 2 (5%) 5 (10%)
Fibrosis 3 (6%) 1 (3%) 3 (6%)
Granuloma 1 (2%)
Hyperplasia 1 (3%)
Inflammation, Chronic 1 (2%) 2 (5%)
Inflammation, Suppurative 3 (6%) 2 (5%) 1 (2%)
Ovary (59) (50) (60)
Atrophy 1 (2%) 1 (2%) 2 (3%)
Cyst 1 (2%) 1 (2%) 4 (7%)
Uterus (59) (50) (60)
a Number of animals examined microscopically at site and number of animals with lesion
Page 4
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0UL/RAT 100UL 300UL
UF RAT LF RAT HF
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - CONT
Dilatation 1 (2%) 2 (4%) 1 (2%)
Inflammation 1 (2%)
Endometrium, Atrophy 23 (39%) 24 (48%) 15 (25%)
Vagina (1) (1)
Exudate 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (57) (49) (59)
Hypoplasia 1 (2%) 1 (2%) 1 (2%)
Lymph Node, Mandibular (59) (50) (60)
Hyperplasia 1 (2%)
Spleen (60) (52) (60)
Congestion 1 (2%)
Fibrosis 2 (3%)
Hematocyst 1 (2%)
Hematopoietic Cell Proliferation 30 (50%) 26 (50%) 22 (37%)
Hyperplasia, Lymphoid 1 (2%)
Infarct 1 (2%)
Necrosis, Focal 1 (2%)
Pigmentation, Hemosiderin 24 (40%) 21 (40%) 27 (45%)
Capsule, Hyperplasia 1 (2%)
Thymus (53) (43) (52)
Congestion 1 (2%)
Cyst 2 (4%) 1 (2%) 1 (2%)
Depletion Lymphoid 2 (4%) 2 (5%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (59) (49) (60)
Hyperplasia 9 (15%) 9 (18%) 9 (15%)
Hyperplasia, Cystic 7 (12%) 1 (2%) 5 (8%)
Lactation 44 (75%) 42 (86%) 43 (72%)
Skin (59) (49) (60)
Other, Acanthosis 2 (3%) 1 (2%)
Other, Hyperkeratosis 1 (2%)
Other, Inflammation, Chronic 1 (2%)
Skin, Control (59) (49) (60)
Acanthosis 3 (5%)
Skin, Site of Application-No Mass (59) (49) (60)
Acanthosis 8 (14%) 18 (37%) 23 (38%)
Inflammation, Chronic 1 (2%)
Ulcer 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 5
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0UL/RAT 100UL 300UL
UF RAT LF RAT HF
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (57) (49) (60)
Fibrous Osteodystrophy 1 (2%) 1 (2%)
Hyperostosis 1 (2%) 1 (2%)
Osteopetrosis 2 (4%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (59) (50) (60)
Compression 7 (12%) 5 (10%) 9 (15%)
Hemorrhage, Focal 1 (2%)
Hydrocephalus 1 (2%)
Cerebrum, Compression 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (59) (50) (60)
Atelectasis 1 (2%)
Atelectasis, Focal 1 (2%)
Congestion 18 (31%) 15 (30%) 14 (23%)
Hemorrhage 1 (2%) 1 (2%)
Infiltration Cellular, Histiocyte 2 (3%) 1 (2%) 2 (3%)
Inflammation, Chronic 8 (14%) 7 (14%) 4 (7%)
Alveolar Epithelium, Hyperplasia 1 (2%) 1 (2%)
Alveolus, Infiltration Cellular, Histiocyte 1 (2%)
Nose (60) (50) (60)
Exudate 1 (2%)
Foreign Body 1 (2%) 4 (7%)
Fungus 3 (5%) 1 (2%)
Inflammation, Chronic 10 (17%) 18 (36%) 16 (27%)
Inflammation, Suppurative 3 (5%) 2 (4%) 2 (3%)
Nares, Ulcer 1 (2%)
Nasolacrimal Duct, Exudate 2 (3%)
Nasolacrimal Duct, Inflammation, Suppurative 4 (8%) 2 (3%)
Trachea (59) (50) (60)
Glands, Dilatation 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (47) (44) (39)
Cataract 47 (100%) 44 (100%) 39 (100%)
Hemorrhage 5 (11%) 2 (5%)
Inflammation 1 (2%)
Inflammation, Chronic 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 6
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0UL/RAT 100UL 300UL
UF RAT LF RAT HF
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - CONT
Phthisis Bulbi 1 (2%)
Cornea, Hyperplasia, Focal, Squamous 1 (2%)
Cornea, Inflammation 2 (4%) 4 (9%) 3 (8%)
Retina, Atrophy 41 (87%) 38 (86%) 32 (82%)
Retrobulbar, Hemorrhage 1 (2%)
Zymbal's Gland (1) (1) (1)
Abscess 1 (100%)
Cyst 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (51) (60)
Hydronephrosis 1 (2%)
Inflammation, Suppurative 1 (2%) 2 (3%)
Nephropathy 52 (87%) 46 (90%) 55 (92%)
Collecting Tubule, Casts 1 (2%)
Cortex, Mineralization, Focal 3 (5%) 2 (3%)
Medulla, Necrosis 1 (2%)
Pelvis, Dilatation 3 (5%) 3 (6%)
Pelvis, Epithelium, Hyperplasia 22 (37%) 23 (45%) 26 (43%)
Pelvis, Epithelium, Mineralization 14 (23%) 16 (31%) 13 (22%)
Pelvis, Epithelium, Mineralization, Focal 3 (5%) 4 (7%)
Perirenal Tissue, Inflammation, Suppurative 1 (2%) 1 (2%)
Proximal Convoluted Renal Tubule, Necrosis 1 (2%) 1 (2%) 2 (3%)
Proximal Convoluted Renal Tubule,
Pigmentation 1 (2%) 2 (4%)
Renal Tubule, Mineralization 2 (3%) 2 (4%) 2 (3%)
Renal Tubule, Necrosis 1 (2%)
Urinary Bladder (57) (47) (59)
Inflammation, Chronic 1 (2%)
Lumen, Hemorrhage 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 7
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0UL/RAT 100UL 300UL
UM RAT LM RAT HM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 60 60 60
Scheduled Sacrifice 10 10 9
Early Deaths
Moribund Sacrifice 31 38 26
Natural Death 15 6 19
Survivors
Moribund Sacrifice 1
Terminal Sacrifice 3 6 6
Animals Examined Microscopically 60 56 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (49) (59)
Hyperkeratosis 4 (7%) 3 (6%) 4 (7%)
Necrosis 1 (2%)
Intestine Large, Cecum (50) (47) (50)
Congestion 1 (2%)
Edema 1 (2%) 1 (2%)
Ulcer 3 (6%)
Serosa, Necrosis, Focal 1 (2%)
Intestine Large, Colon (51) (47) (53)
Edema 1 (2%) 2 (4%)
Parasite Metazoan 3 (6%) 1 (2%) 1 (2%)
Ulcer 1 (2%)
Muscularis, Degeneration, Focal 1 (2%)
Muscularis, Necrosis, Focal 1 (2%)
Serosa, Necrosis, Focal 1 (2%)
Intestine Small, Duodenum (57) (49) (56)
Ulcer 1 (2%)
Mucosa, Erosion, Focal 3 (5%) 2 (4%)
Intestine Small, Ileum (54) (46) (49)
Hemorrhage, Focal 1 (2%)
Mucosa, Necrosis 1 (2%)
Intestine Small, Jejunum (52) (46) (49)
Intussusception 1 (2%)
Liver (60) (50) (60)
Angiectasis 1 (2%)
Basophilic Focus 1 (2%)
Clear Cell Focus 4 (7%) 1 (2%)
Degeneration, Cystic, Focal 2 (3%) 3 (6%) 2 (3%)
Degeneration, Fatty 19 (32%) 5 (10%) 2 (3%)
Degeneration, Fatty, Focal 1 (2%) 1 (2%)
Eosinophilic Focus 2 (3%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 8
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0UL/RAT 100UL 300UL
UM RAT LM RAT HM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Fibrosis, Focal 2 (3%)
Focal Cellular Change 1 (2%)
Hematopoietic Cell Proliferation 1 (2%) 1 (2%)
Hepatodiaphragmatic Nodule 2 (3%) 1 (2%) 1 (2%)
Inflammation, Chronic, Focal 9 (15%) 11 (22%) 12 (20%)
Inflammation, Focal, Granulomatous 8 (13%) 7 (12%)
Necrosis 1 (2%) 3 (6%) 6 (10%)
Bile Duct, Hyperplasia 53 (88%) 42 (84%) 47 (78%)
Centrilobular, Degeneration, Fatty 1 (2%) 2 (4%) 1 (2%)
Hepatocyte, Atrophy 1 (2%)
Hepatocyte, Hyperplasia, Focal 2 (3%)
Midzonal, Degeneration, Fatty 2 (3%) 1 (2%)
Peripheral, Degeneration, Fatty 4 (7%) 1 (2%) 1 (2%)
Serosa, Inflammation, Necrotizing 1 (2%)
Mesentery (4) (3) (1)
Fat, Granuloma 2 (50%) 2 (67%) 1 (100%)
Pancreas (60) (50) (59)
Accessory Spleen 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%) 1 (2%) 1 (2%)
Edema 2 (3%)
Fibrosis 1 (2%)
Acinus, Atrophy 17 (28%) 17 (34%) 26 (44%)
Acinus, Hyperplasia, Focal 1 (2%)
Interlobular, Inflammation, Chronic 1 (2%)
Salivary Glands (58) (50) (59)
Concretion 1 (2%)
Stomach (59) (50) (59)
Muscularis, Necrosis 1 (2%)
Muscularis, Necrosis, Focal 2 (3%) 3 (6%) 1 (2%)
Serosa, Inflammation, Necrotizing 1 (2%)
Serosa, Inflammation, Suppurative 1 (2%)
Serosa, Necrosis, Focal 1 (2%)
Stomach, Forestomach (59) (50) (59)
Acanthosis 25 (42%) 21 (42%) 24 (41%)
Edema 13 (22%) 9 (18%) 10 (17%)
Hyperkeratosis 25 (42%) 20 (40%) 24 (41%)
Ulcer 13 (22%) 13 (26%) 8 (14%)
Muscularis, Necrosis 2 (3%)
Serosa, Inflammation, Suppurative 1 (2%)
Serosa, Inflammation, Proliferative 1 (2%)
Serosa, Necrosis, Focal 1 (2%)
Stomach, Glandular (59) (50) (58)
Dilatation 1 (2%)
Fibrosis 1 (2%)
Foreign Body 1 (2%)
Epithelium, Degeneration 1 (2%)
Epithelium, Hyperplasia 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 9
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0UL/RAT 100UL 300UL
UM RAT LM RAT HM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - CONT
Mucosa, Degeneration 11 (19%) 5 (10%) 4 (7%)
Mucosa, Erosion, Focal 1 (2%) 2 (4%) 1 (2%)
Muscularis, Necrosis, Focal 1 (2%)
Tooth (1)
Inflammation, Suppurative 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (13) (8) (2)
Degeneration 13 (100%) 7 (88%) 2 (100%)
Heart (60) (50) (59)
Abscess 1 (2%)
Cardiomyopathy 53 (88%) 44 (88%) 52 (88%)
Atrium, Dilatation 1 (2%)
Atrium, Thrombosis 6 (10%) 5 (10%) 3 (5%)
Myocardium, Necrosis 1 (2%)
Myocardium, Necrosis, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (59) (50) (59)
Angiectasis 1 (2%) 1 (2%)
Cytoplasmic Alteration, Focal 1 (2%)
Degeneration 7 (12%) 3 (6%) 1 (2%)
Degeneration, Fatty, Focal 21 (36%) 21 (42%) 15 (25%)
Hyperplasia, Focal 6 (10%) 9 (18%) 8 (14%)
Hypertrophy, Focal 1 (2%)
Metaplasia, Focal, Osseous 1 (2%)
Adrenal Gland, Medulla (59) (50) (57)
Hyperplasia, Focal 21 (36%) 25 (50%) 14 (25%)
Islets, Pancreatic (50) (50) (49)
Hyperplasia 1 (2%) 2 (4%)
Parathyroid Gland (57) (49) (57)
Hyperplasia, Focal 1 (2%) 1 (2%)
Hypertrophy 32 (56%) 30 (61%) 19 (33%)
Pituitary Gland (54) (49) (58)
Angiectasis 1 (2%) 1 (2%)
Cyst 2 (4%)
Hemorrhage 2 (3%)
Pigmentation 1 (2%) 1 (2%)
Pigmentation, Hemosiderin 1 (2%)
Pars Distalis, Cyst 1 (2%) 1 (2%)
Pars Distalis, Hyperplasia, Focal 4 (7%) 3 (6%) 10 (17%)
Thyroid Gland (58) (50) (57)
C-Cell, Hyperplasia 7 (12%) 7 (14%) 8 (14%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 10
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0UL/RAT 100UL 300UL
UM RAT LM RAT HM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Follicular Cell, Hyperplasia 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (4) (3) (2)
Hemorrhage 1 (50%)
Inflammation, Suppurative 1 (25%)
Inflammation, Proliferative 1 (50%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1) (1)
Inflammation 1 (100%)
Inflammation, Suppurative 1 (100%)
Epididymis (58) (48) (59)
Degeneration, Focal 35 (60%) 38 (79%) 31 (53%)
Fibrosis 20 (34%) 20 (42%) 11 (19%)
Penis (6) (2) (2)
Inflammation, Acute 3 (50%) 2 (100%)
Thrombosis 1 (17%)
Preputial Gland (44) (46) (54)
Abscess 2 (5%) 1 (2%) 2 (4%)
Abscess, Acute 1 (2%)
Ectasia 4 (9%) 1 (2%) 4 (7%)
Fibrosis 21 (48%) 23 (50%) 24 (44%)
Hyperplasia 1 (2%)
Inflammation, Chronic 5 (11%) 3 (6%)
Duct, Inflammation, Suppurative 1 (2%)
Prostate (58) (50) (58)
Cyst 1 (2%)
Hyperplasia, Focal 1 (2%) 3 (5%)
Inflammation, Chronic 1 (2%) 1 (2%) 2 (3%)
Inflammation, Suppurative 29 (50%) 25 (50%) 27 (47%)
Seminal Vesicle (58) (50) (58)
Atrophy 15 (26%) 13 (26%) 12 (21%)
Depletion Cellular 17 (29%) 21 (42%) 10 (17%)
Hyperplasia 1 (2%)
Inflammation, Suppurative 2 (3%) 4 (8%) 1 (2%)
Testes (60) (50) (59)
Hypoplasia 1 (2%) 1 (2%) 1 (2%)
Polyarteritis 3 (5%) 4 (8%) 4 (7%)
Interstitial Cell, Hyperplasia 4 (7%) 1 (2%) 3 (5%)
Seminiferous Tubule, Atrophy 23 (38%) 31 (62%) 20 (34%)
Seminiferous Tubule, Degeneration 14 (23%) 8 (16%) 8 (14%)
Unilateral, Atrophy 2 (3%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 11
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0UL/RAT 100UL 300UL
UM RAT LM RAT HM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (59) (49) (57)
Hypoplasia 6 (10%) 6 (12%) 3 (5%)
Lymph Node (60) (50) (59)
Hemorrhage 1 (2%)
Mediastinal, Angiectasis 2 (4%)
Mediastinal, Hemorrhage 2 (3%) 1 (2%)
Lymph Node, Mandibular (58) (50) (58)
Hyperplasia 1 (2%)
Lymph Node, Mesenteric (54) (50) (55)
Angiectasis 1 (2%)
Congestion 1 (2%)
Hemorrhage 3 (6%) 1 (2%)
Inflammation, Granulomatous 1 (2%)
Spleen (60) (50) (59)
Congestion 3 (5%) 3 (5%)
Depletion Lymphoid 1 (2%)
Fibrosis 4 (7%) 4 (8%) 4 (7%)
Hematopoietic Cell Proliferation 8 (13%) 9 (18%) 7 (12%)
Infarct 1 (2%) 2 (3%)
Pigmentation, Hemosiderin 26 (43%) 14 (28%) 23 (39%)
Capsule, Hyperplasia 1 (2%)
Capsule, Hyperplasia, Focal 1 (2%)
Thymus (45) (37) (44)
Depletion Lymphoid 5 (11%) 4 (11%) 7 (16%)
Hemorrhage 1 (2%)
Hyperplasia, Pseudoepitheliomatous 2 (5%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (54) (38) (52)
Abscess 1 (2%)
Galactocele 1 (3%)
Hyperplasia 1 (2%) 3 (8%) 2 (4%)
Hyperplasia, Cystic 1 (2%)
Lactation 39 (72%) 37 (97%) 40 (77%)
Duct, Ectasia 1 (2%)
Duct, Pigmentation 1 (2%)
Skin (59) (56) (60)
Abdominal, Edema 1 (2%)
Abdominal, Exudate 1 (2%)
Abdominal, Inflammation, Suppurative 1 (2%)
Abdominal, Subcutaneous Tissue, Edema 1 (2%)
Foot, Hemorrhage 1 (2%)
Other, Cyst Epithelial Inclusion 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 12
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0UL/RAT 100UL 300UL
UM RAT LM RAT HM
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Other, Inflammation, Acute 1 (2%)
Other, Inflammation, Suppurative 3 (5%) 1 (2%)
Prepuce, Hyperkeratosis 1 (2%)
Prepuce, Inflammation 1 (2%)
Sebaceous Gland, Site of Application-Mass,
Hyperplasia 1 (2%)
Site of Application-Mass, Fibrosis, Focal 1 (2%)
Site of Application-Mass, Hyperplasia,
Squamous 1 (2%)
Skin, Control (60) (50) (59)
Acanthosis 1 (2%)
Cyst Epithelial Inclusion 1 (2%)
Skin, Site of Application-No Mass (60) (55) (60)
Acanthosis 2 (3%) 10 (18%) 27 (45%)
Cyst Epithelial Inclusion 3 (5%)
Exudate 1 (2%)
Hyperkeratosis 2 (3%)
Inflammation, Suppurative 1 (2%) 1 (2%)
Proliferation Connective Tissue 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (59) (49) (58)
Fibrous Osteodystrophy 22 (37%) 19 (39%) 11 (19%)
Hyperostosis 1 (2%) 1 (2%)
Hypoplasia 1 (2%)
Skeletal Muscle (1) (1) (1)
Degeneration, Focal 1 (100%)
Diaphragm, Inflammation, Proliferative 1 (100%)
Diaphragm, Necrosis, Focal 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (50) (59)
Compression 5 (8%) 8 (16%) 9 (15%)
Hemorrhage 1 (2%) 1 (2%)
Hydrocephalus 1 (2%) 1 (2%)
Infarct 1 (2%)
Inflammation, Chronic, Focal 1 (2%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 13
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0UL/RAT 100UL 300UL
UM RAT LM RAT HM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (50) (60)
Atelectasis 2 (3%) 1 (2%)
Congestion 18 (30%) 13 (26%) 18 (30%)
Edema 1 (2%)
Hemorrhage 1 (2%) 1 (2%) 2 (3%)
Infiltration Cellular, Histiocyte 1 (2%) 3 (6%) 1 (2%)
Inflammation, Acute 1 (2%)
Inflammation, Chronic 22 (37%) 14 (28%) 11 (18%)
Alveolar Epithelium, Hyperplasia 1 (2%)
Alveolar Epithelium, Hyperplasia, Focal 1 (2%)
Nose (60) (50) (58)
Exudate 1 (2%)
Fibrosis, Focal 1 (2%)
Foreign Body 3 (5%) 5 (10%)
Fungus 4 (7%) 4 (8%) 7 (12%)
Infiltration Cellular, Diffuse, Lymphocyte 1 (2%)
Infiltration Cellular, Mixed Cell 1 (2%)
Inflammation, Chronic 4 (7%) 5 (10%) 5 (9%)
Inflammation, Suppurative 7 (12%) 2 (4%) 7 (12%)
Nasolacrimal Duct, Exudate 1 (2%)
Nasolacrimal Duct, Inflammation, Chronic 1 (2%)
Nasolacrimal Duct, Inflammation, Suppurative 2 (3%) 1 (2%) 2 (3%)
Submucosa, Olfactory Epithelium, Glands,
Hypertrophy 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (2) (3)
Hyperkeratosis 1 (100%)
Ulcer 1 (33%)
Eye (45) (43) (42)
Cataract 43 (96%) 43 (100%) 42 (100%)
Hemorrhage 4 (9%) 4 (9%) 1 (2%)
Synechia 1 (2%)
Anterior Chamber, Hemorrhage 1 (2%)
Anterior Chamber, Inflammation, Suppurative 1 (2%) 1 (2%)
Cornea, Inflammation 5 (11%) 4 (9%)
Retina, Atrophy 36 (80%) 35 (81%) 34 (81%)
Zymbal's Gland (3)
Abscess 2 (67%)
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
Page 14
NTP Experiment-Test: 05106-01 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03
Study Type: CHRONIC DIETHYLPHTHALATE Date: 05/19/95
Route: SKIN APPLICATION Time: 20:47:31
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0UL/RAT 100UL 300UL
UM RAT LM RAT HM
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (50) (60)
Inflammation, Suppurative 1 (2%)
Nephropathy 60 (100%) 50 (100%) 60 (100%)
Pelvis, Dilatation 1 (2%) 2 (4%)
Pelvis, Epithelium, Hyperplasia 30 (50%) 28 (56%) 22 (37%)
Pelvis, Epithelium, Inflammation 1 (2%)
Pelvis, Epithelium, Mineralization 2 (4%) 1 (2%)
Renal Tubule, Mineralization 1 (2%)
Urinary Bladder (58) (50) (56)
Hemorrhage 1 (2%)
Inflammation, Chronic 1 (2%) 1 (2%)
Inflammation, Suppurative 1 (2%)
Necrosis 1 (2%)
Mucosa, Hyperplasia 2 (3%) 1 (2%)
a Number of animals examined microscopically at site and number of animals with lesion
Page 15
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