NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
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: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.4%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 110 110
Scheduled Sacrifice 10 10
Early Deaths
Dead 4 1
Moribund 11 10
Moribund Sacrifice 34 38
Natural Death 6 1
Survivors
Terminal Sacrifice 10 11
Animals Examined Microscopically 110 110
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (109) (109)
Intestine Large, Cecum (110) (110)
Intestine Small, Duodenum (109) (110)
Intestine Small, Jejunum (110) (110)
Leiomyosarcoma 1 (1%) 1 (1%)
Intestine Small, Ileum (110) (110)
Liver (110) (110)
Hepatocellular Carcinoma 3 (3%)
Hepatocellular Adenoma 2 (2%) 4 (4%)
Mesentery (6) (5)
Lipoma 1 (20%)
Pancreas (107) (110)
Acinus, Adenoma 1 (1%)
Salivary Glands (109) (110)
Stomach, Forestomach (107) (110)
Stomach, Glandular (108) (110)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
Tooth (4)
Odontoma 1 (25%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (110) (110)
Schwannoma Malignant 1 (1%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.4%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (110) (110)
Carcinoma 1 (1%)
Adrenal Medulla (108) (110)
Pheochromocytoma Malignant 1 (1%)
Pheochromocytoma Complex 1 (1%)
Pheochromocytoma Benign 3 (3%) 5 (5%)
Islets, Pancreatic (107) (110)
Adenoma 1 (1%) 1 (1%)
Carcinoma 1 (1%)
Pituitary Gland (110) (109)
Pars Distalis, Adenoma 39 (35%) 22 (20%)
Pars Distalis, Adenoma, Multiple 2 (2%)
Pars Distalis, Carcinoma 1 (1%)
Thyroid Gland (109) (110)
C-Cell, Adenoma 6 (6%) 7 (6%)
C-Cell, Carcinoma 1 (1%)
Follicular Cell, Adenoma 1 (1%)
Follicular Cell, Carcinoma 1 (1%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (110) (109)
Adenoma 9 (8%) 5 (5%)
Carcinoma 5 (5%)
Ovary (110) (110)
Granulosa Cell Tumor Benign 1 (1%)
Uterus (110) (110)
Adenoma 1 (1%)
Polyp Stromal 3 (3%) 9 (8%)
Polyp Stromal, Multiple 1 (1%)
Sarcoma Stromal 1 (1%)
Vagina (2) (2)
Squamous Cell Papilloma 1 (50%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.4%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (110) (110)
Lymph Node (32) (27)
Lymph Node, Mandibular (109) (110)
Lymph Node, Mesenteric (110) (110)
Spleen (110) (110)
Thymus (109) (106)
Thymoma Benign 1 (1%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (109) (109)
Carcinoma 5 (5%) 1 (1%)
Fibroadenoma 28 (26%) 7 (6%)
Fibroadenoma, Multiple 5 (5%)
Skin (110) (109)
Keratoacanthoma 3 (3%) 1 (1%)
Squamous Cell Papilloma 2 (2%)
Sebaceous Gland, Basal Cell Adenoma 1 (1%)
Subcutaneous Tissue, Fibroma 4 (4%)
Subcutaneous Tissue, Fibroma, Multiple 1 (1%)
Subcutaneous Tissue, Melanoma Malignant 1 (1%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (110) (110)
Osteosarcoma 1 (1%)
Skeletal Muscle (1)
Rhabdomyosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (110) (109)
Astrocytoma Malignant 1 (1%) 1 (1%)
Carcinoma, Metastatic, Pituitary Gland 1 (1%)
Carcinoma, Metastatic, Zymbal's Gland 1 (1%)
Ependymoma Malignant 1 (1%)
Glioma Malignant 1 (1%)
Oligodendroglioma Malignant 1 (1%) 1 (1%)
Spinal Cord (3) (1)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.4%
CONTROL
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (110) (110)
Alveolar/Bronchiolar Adenoma 1 (1%) 1 (1%)
Alveolar/Bronchiolar Carcinoma 1 (1%)
Carcinoma, Metastatic, Zymbal's Gland 1 (1%)
Sarcoma, Metastatic, Tissue NOS 1 (1%)
Nose (110) (110)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (2) (2)
Carcinoma 2 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (110) (110)
Urinary Bladder (109) (110)
Mast Cell Tumor Benign 1 (1%)
Transitional Epithelium, Carcinoma 4 (4%)
Transitional Epithelium, Papilloma 1 (1%) 4 (4%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(110) *(110)
Leukemia Mononuclear 45 (41%) 58 (53%)
Mesothelioma NOS 1 (1%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE UNTREATD 2.4%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 94 78
Total Primary Neoplasms 192 144
Total Animals with Benign Neoplasms 74 49
Total Benign Neoplasms 119 69
Total Animals with Malignant Neoplasms 63 62
Total Malignant Neoplasms 73 74
Total Animals with Metastatic Neoplasms 2 1
Total Metastatic Neoplasm 2 2
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 2
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 6
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.2%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 110 110
Scheduled Sacrifice 10 10
Early Deaths
Moribund 14 17
Accidently Killed 1
Dead 1 2
Moribund Sacrifice 37 29
Natural Death 3 8
Survivors
Terminal Sacrifice 10 13
Animals Examined Microscopically 110 110
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (108) (106)
Intestine Large, Cecum (108) (109)
Intestine Small, Duodenum (110) (109)
Intestine Small, Jejunum (109) (108)
Carcinoma 2 (2%)
Intestine Small, Ileum (109) (108)
Sarcoma 1 (1%)
Liver (110) (109)
Hepatocellular Carcinoma 2 (2%)
Hepatocellular Adenoma 2 (2%)
Hepatocellular Adenoma, Multiple 1 (1%)
Histiocytic Sarcoma 1 (1%)
Mesentery (22) (19)
Fibrous Histiocytoma 1 (5%)
Sarcoma 1 (5%)
Schwannoma Malignant 1 (5%)
Oral Mucosa (3) (1)
Squamous Cell Carcinoma 2 (67%)
Squamous Cell Papilloma 1 (33%) 1 (100%)
Pancreas (110) (109)
Sarcoma, Metastatic, Mesentery 1 (1%)
Acinar Cell, Adenoma 1 (1%)
Acinus, Adenoma 1 (1%)
Acinus, Adenoma, Multiple 1 (1%)
Salivary Glands (110) (109)
Fibrous Histiocytoma, Metastatic, Skin 1 (1%)
Schwannoma Malignant 1 (1%)
Stomach, Forestomach (110) (110)
Page 7
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.2%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - cont
Leiomyosarcoma 1 (1%)
Squamous Cell Papilloma 5 (5%) 1 (1%)
Stomach, Glandular (110) (109)
Tongue (2) (1)
Squamous Cell Carcinoma 1 (50%)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (110) (110)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (110) (110)
Adenoma 1 (1%)
Adrenal Medulla (110) (110)
Pheochromocytoma Malignant 1 (1%) 2 (2%)
Pheochromocytoma Benign 9 (8%) 10 (9%)
Pheochromocytoma Benign, Multiple 1 (1%)
Bilateral, Pheochromocytoma Benign 2 (2%)
Islets, Pancreatic (110) (109)
Adenoma 7 (6%) 6 (6%)
Carcinoma 3 (3%) 3 (3%)
Pituitary Gland (106) (105)
Pars Distalis, Adenoma 11 (10%) 11 (10%)
Pars Distalis, Adenoma, Multiple 2 (2%)
Thyroid Gland (110) (110)
C-Cell, Adenoma 8 (7%) 8 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Peritoneum (4) (3)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (110) (110)
Preputial Gland (110) (110)
Adenoma 1 (1%) 3 (3%)
Carcinoma 1 (1%)
Prostate (109) (110)
Adenoma 1 (1%)
Carcinoma 1 (1%)
Seminal Vesicle (110) (108)
Page 8
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.2%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Testes (110) (110)
Bilateral, Interstitial Cell, Adenoma 80 (73%) 81 (74%)
Interstitial Cell, Adenoma 20 (18%) 18 (16%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (110) (110)
Histiocytic Sarcoma 1 (1%)
Lymph Node (42) (42)
Mediastinal, Fibrous Histiocytoma 1 (2%)
Mediastinal, Histiocytic Sarcoma 1 (2%)
Lymph Node, Mandibular (107) (106)
Histiocytic Sarcoma 1 (1%)
Lymph Node, Mesenteric (110) (109)
Histiocytic Sarcoma 1 (1%)
Spleen (110) (109)
Fibroma 1 (1%)
Sarcoma 1 (1%)
Thymus (102) (103)
Thymoma Benign 2 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (104) (108)
Carcinoma 1 (1%)
Fibroadenoma 5 (5%) 3 (3%)
Skin (109) (108)
Keratoacanthoma 4 (4%) 4 (4%)
Trichoepithelioma 1 (1%)
Subcutaneous Tissue, Fibroma 5 (5%) 3 (3%)
Subcutaneous Tissue, Fibrosarcoma 1 (1%)
Subcutaneous Tissue, Fibrous Histiocytoma 1 (1%)
Subcutaneous Tissue, Lipoma 1 (1%)
Subcutaneous Tissue, Melanoma Benign 2 (2%)
Subcutaneous Tissue, Melanoma Malignant 1 (1%) 1 (1%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2)
Fibrous Histiocytoma 1 (50%)
Fibrous Histiocytoma, Metastatic, Skin 1 (50%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.2%
CONTROL
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (110) (109)
Astrocytoma Malignant 2 (2%) 1 (1%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (110) (110)
Alveolar/Bronchiolar Adenoma 1 (1%) 2 (2%)
Alveolar/Bronchiolar Carcinoma 1 (1%) 1 (1%)
Sarcoma, Metastatic, Mesentery 1 (1%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1) (1)
Schwannoma Malignant 1 (100%)
Zymbal's Gland (2) (1)
Carcinoma 2 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (110) (109)
Urinary Bladder (110) (110)
Transitional Epithelium, Carcinoma 1 (1%)
Transitional Epithelium, Papilloma 2 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(110) *(110)
Histiocytic Sarcoma 1 (1%)
Leukemia Mononuclear 60 (55%) 64 (58%)
Mesothelioma Malignant 4 (4%) 3 (3%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05094-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 04/03/96
Route: DOSED FEED Time: 15:03:21
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE UNTREATD 1.2%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 107 104
Total Primary Neoplasms 252 253
Total Animals with Benign Neoplasms 103 102
Total Benign Neoplasms 165 166
Total Animals with Malignant Neoplasms 75 75
Total Malignant Neoplasms 87 87
Total Animals with Metastatic Neoplasms 1 1
Total Metastatic Neoplasm 2 2
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant
Total Uncertain Neoplasms
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 11
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