TDMS Study 05094-99 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) BUTYL BENZYL PHTHALATE NTP Experiment-Test: 05094-99 Report: PEIRPT05 Study Type: CHRONIC Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 05094/02 -VS- 05094/03 COMPARISON Facility: SOUTHERN RESEARCH INSTITUTE Chemical CAS #: 85-68-7 Lock Date: 11/25/92 Cage Range: All Reasons For Removal: 25022 Accidently Killed 25004 Dead 25005 Interval Sacrifice 25003 Moribund 25019 Moribund Sacrifice 25020 Natural Death 25026 Other 25021 Terminal Sacrifice Removal Date Range: All Treatment Groups: Include 001 AD LIB CONTROL Include 002 AD LIB CONTROL Include 005 RTD CONTROL Include 006 RTD CONTROL a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 110 Scheduled Sacrifice 35 Early Deaths Moribund Sacrifice 23 2 Natural Death 2 Dead 4 Moribund 11 Survivors Terminal Sacrifice 25 Animals Examined Microscopically 50 52 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (50) (52) Intestine Small, Jejunum (50) (52) Leiomyosarcoma 1 (2%) Liver (50) (52) Hepatocellular Adenoma 1 (2%) Mesentery (10) (1) Liposarcoma 1 (10%) Pancreas (50) (49) Salivary Glands (49) (51) Stomach, Forestomach (50) (51) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (52) Tongue (3) Squamous Cell Papilloma 2 (67%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (52) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (52) Adenoma 1 (2%) Carcinoma 1 (2%) Adrenal Medulla (49) (51) Pheochromocytoma Malignant 1 (2%) Page 2 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 1 (2%) 1 (2%) Islets, Pancreatic (50) (49) Adenoma 1 (2%) Carcinoma 1 (2%) Pituitary Gland (49) (52) Pars Distalis, Adenoma 19 (39%) 17 (33%) Pars Distalis, Adenoma, Multiple 1 (2%) Pars Distalis, Carcinoma 2 (4%) Thyroid Gland (49) (51) C-Cell, Adenoma 4 (8%) 2 (4%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (52) Adenoma 3 (6%) 3 (6%) Carcinoma 4 (8%) Ovary (50) (52) Granulosa Cell Tumor Benign 2 (4%) 1 (2%) Uterus (50) (52) Adenoma 1 (2%) Leiomyoma 1 (2%) Leiomyosarcoma 1 (2%) Polyp Stromal 6 (12%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (52) Lymph Node (12) (10) Lymph Node, Mandibular (49) (51) Lymph Node, Mesenteric (50) (52) Spleen (50) (52) Thymus (49) (52) Thymoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (52) Adenoma 2 (4%) Carcinoma 2 (4%) 1 (2%) Fibroadenoma 28 (57%) 10 (19%) Fibroadenoma, Multiple 2 (4%) Skin (50) (52) Keratoacanthoma 1 (2%) 1 (2%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (52) Astrocytoma Malignant 1 (2%) Carcinoma 1 (2%) Carcinoma, Metastatic, Pituitary Gland 2 (4%) Oligodendroglioma Malignant 1 (2%) Spinal Cord (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (52) Alveolar/Bronchiolar Adenoma 2 (4%) 1 (2%) Sarcoma, Metastatic, Tissue NOS 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (52) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (50) (52) Mast Cell Tumor Benign 1 (2%) Page 4 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(52) Leukemia Mononuclear 21 (42%) 17 (33%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 44 Total Primary Neoplasms 112 72 Total Animals with Benign Neoplasms 40 31 Total Benign Neoplasms 77 45 Total Animals with Malignant Neoplasms 30 25 Total Malignant Neoplasms 35 27 Total Animals with Metastatic Neoplasms 2 1 Total Metastatic Neoplasm 2 1 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 6 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 110 Scheduled Sacrifice 34 Early Deaths Moribund Sacrifice 19 Natural Death 3 Moribund 14 Dead 1 Survivors Terminal Sacrifice 28 Accidently Killed 1 Animals Examined Microscopically 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Rectum (49) (50) Leiomyosarcoma 1 (2%) Intestine Small, Duodenum (50) (50) Intestine Small, Jejunum (49) (49) Leiomyoma 1 (2%) Intestine Small, Ileum (49) (49) Liver (50) (50) Hepatocellular Adenoma 2 (4%) 1 (2%) Mesentery (7) (7) Sarcoma 1 (14%) Oral Mucosa (1) Squamous Cell Carcinoma 1 (100%) Pancreas (50) (50) Sarcoma, Metastatic, Mesentery 1 (2%) Acinus, Adenoma 3 (6%) Stomach, Forestomach (50) (50) Leiomyosarcoma 1 (2%) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (50) (50) Tongue (1) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) Adrenal Medulla (50) (50) Pheochromocytoma Malignant 2 (4%) 1 (2%) Pheochromocytoma Benign 6 (12%) 3 (6%) Pheochromocytoma Benign, Multiple 3 (6%) Islets, Pancreatic (50) (50) Adenoma 5 (10%) 4 (8%) Carcinoma 1 (2%) Pituitary Gland (50) (46) Pars Distalis, Adenoma 9 (18%) 4 (9%) Pars Distalis, Adenoma, Multiple 1 (2%) Thyroid Gland (50) (50) C-Cell, Adenoma 5 (10%) 4 (8%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (2) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) Preputial Gland (50) (50) Adenoma 4 (8%) 1 (2%) Carcinoma 1 (2%) Prostate (50) (49) Seminal Vesicle (50) (50) Testes (50) (50) Bilateral, Interstitial Cell, Adenoma 37 (74%) 42 (84%) Interstitial Cell, Adenoma 7 (14%) 5 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) Lymph Node (23) (12) Iliac, Leiomyosarcoma, Metastatic, Intestine Large, Rectum 1 (4%) Lymph Node, Mandibular (49) (48) Lymph Node, Mesenteric (50) (50) Page 8 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - cont Spleen (50) (50) Thymus (49) (46) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (45) (49) Fibroadenoma 2 (4%) 2 (4%) Skin (50) (49) Basal Cell Carcinoma 1 (2%) Keratoacanthoma 2 (4%) 2 (4%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 5 (10%) Subcutaneous Tissue, Melanoma Malignant 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) Chordoma 1 (2%) Skeletal Muscle (1) Hemangiosarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) Oligodendroglioma Malignant 1 (2%) Spinal Cord (2) (1) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) Chordoma, Metastatic, Bone 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (1) Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (50) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) Leukemia Mononuclear 31 (62%) 21 (42%) Mesothelioma Malignant 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 05094-99 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC BUTYL BENZYL PHTHALATE Date: 05/11/95 Route: DOSED FEED Time: 10:20:09 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE AD LIB RTD CONTROL CONTROL ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 49 Total Primary Neoplasms 135 100 Total Animals with Benign Neoplasms 46 48 Total Benign Neoplasms 94 69 Total Animals with Malignant Neoplasms 37 29 Total Malignant Neoplasms 41 31 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 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 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------