TDMS Study 90004-07 Pathology Tables
NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 FINAL#1/RATS Facility: Battelle Northwest Chemical CAS #: 57018-52-7 Lock Date: 12/11/00 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: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 14 12 20 11 Natural Death 3 4 2 3 Survivors Terminal Sacrifice 33 34 28 36 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Liver (49) (50) (50) (50) Hepatocellular Adenoma 1 (2%) 2 (4%) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Mesentery (17) (23) (10) (17) Carcinoma, Metastatic, Ovary 1 (10%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (50) (50) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (49) (50) (50) (50) Adenoma 2 (4%) 2 (4%) 1 (2%) 4 (8%) Carcinoma 2 (4%) 1 (2%) Adrenal Medulla (49) (50) (50) (50) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 2 (4%) 1 (2%) Islets, Pancreatic (49) (50) (50) (50) Adenoma 1 (2%) 1 (2%) 2 (4%) Carcinoma 1 (2%) Pituitary Gland (49) (50) (50) (49) Adenoma 30 (61%) 36 (72%) 32 (64%) 22 (45%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Thyroid Gland (49) (50) (50) (50) C-Cell, Adenoma 8 (16%) 2 (4%) 3 (6%) 4 (8%) C-Cell, Carcinoma 2 (4%) Page 2 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Follicular Cell, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (50) (50) Adenoma 1 (2%) Carcinoma 2 (4%) 2 (4%) 1 (2%) Sarcoma, Metastatic, Vagina 1 (2%) Ovary (50) (50) (50) (50) Cystadenocarcinoma 1 (2%) 1 (2%) Granulosa Cell Tumor Malignant 1 (2%) Granulosa-Theca Tumor Malignant 1 (2%) Uterus (50) (50) (50) (50) Leiomyosarcoma 1 (2%) Polyp Stromal 5 (10%) 7 (14%) 11 (22%) 6 (12%) Sarcoma Stromal 1 (2%) Bilateral, Polyp Stromal 1 (2%) Endometrium, Adenoma 1 (2%) Vagina (1) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (5) (3) (3) (6) Lymph Node, Bronchial (9) (4) (10) (5) Histiocytic Sarcoma, Metastatic, Skin 1 (20%) Squamous Cell Carcinoma, Metastatic, Lung 1 (10%) Lymph Node, Mandibular (1) (2) (2) Lymph Node, Mesenteric (50) (50) (50) (50) Lymph Node, Mediastinal (43) (46) (45) (43) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Squamous Cell Carcinoma, Metastatic, Lung 2 (4%) Spleen (49) (50) (50) (50) Thymus (45) (50) (50) (48) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (49) (50) (50) (50) Adenoma 2 (4%) Carcinoma 4 (8%) 4 (8%) 1 (2%) 1 (2%) Carcinoma, Multiple 1 (2%) Fibroadenoma 18 (37%) 21 (42%) 17 (34%) 20 (40%) Fibroadenoma, Multiple 7 (14%) 8 (16%) 4 (8%) 9 (18%) Sarcoma, Metastatic, Vagina 1 (2%) Skin (50) (50) (50) (50) Squamous Cell Papilloma 1 (2%) Eyelid, Neural Crest Tumor 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrous Histiocytoma 1 (2%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Liposarcoma 1 (2%) Subcutaneous Tissue, Sarcoma, Metastatic, Vagina 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (2) Fibrous Histiocytoma, Metastatic, Skin 1 (100%) Squamous Cell Carcinoma, Metastatic, Lung 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (50) (50) (50) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Pineal Gland, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (50) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Carcinoma, Metastatic, Adrenal Cortex 1 (2%) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Sarcoma, Metastatic, Vagina 1 (2%) Squamous Cell Carcinoma 2 (4%) Page 4 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - cont Alveolus, Squamous Cell Carcinoma, Metastatic, Lung 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Zymbal's Gland (42) (44) (43) (46) Carcinoma 2 (5%) 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (49) (50) (50) (50) Cortex, Renal Tubule, Adenoma 1 (2%) Urinary Bladder (49) (50) (50) (50) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 24 (48%) 24 (48%) 28 (56%) 20 (40%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 49 48 50 45 Total Primary Neoplasms 117 116 109 97 Total Animals with Benign Neoplasms 41 45 42 41 Total Benign Neoplasms 75 82 71 72 Total Animals with Malignant Neoplasms 33 27 32 23 Total Malignant Neoplasms 42 34 37 25 Total Animals with Metastatic Neoplasms 4 1 3 1 Total Metastatic Neoplasm 8 1 6 4 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 Total Uncertain Neoplasms 1 ____________________________________________________________________________________________________________________________________ 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: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 50 50 50 50 Early Deaths Moribund Sacrifice 20 15 26 22 Natural Death 3 6 8 6 Survivors Terminal Sacrifice 27 29 16 22 Animals Examined Microscopically 50 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (50) (50) (49) (50) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Intestine Large, Colon (49) (48) (46) (48) Polyp Adenomatous 1 (2%) Intestine Large, Cecum (47) (47) (47) (45) Intestine Small, Ileum (47) (47) (43) (45) Liver (50) (50) (49) (50) Cholangiocarcinoma 1 (2%) Hepatocellular Adenoma 3 (6%) 2 (4%) 6 (12%) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Mesentery (13) (9) (10) (7) Stomach, Forestomach (50) (50) (49) (50) Stomach, Glandular (50) (50) (49) (50) Carcinoma 1 (2%) Muscularis, Lipoma 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (50) (50) (49) (50) Aorta, Pulmonary Artery, Sarcoma, Metastatic, Heart 1 (2%) Heart (50) (50) (49) (50) Carcinoma, Metastatic, Lung 1 (2%) Pericardium, Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Medulla (50) (50) (49) (50) Pheochromocytoma Malignant 2 (4%) 2 (4%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 10 (20%) 8 (16%) 8 (16%) 6 (12%) Bilateral, Pheochromocytoma Benign 2 (4%) 3 (6%) 1 (2%) Islets, Pancreatic (50) (50) (49) (50) Adenoma 4 (8%) 4 (8%) 5 (10%) Carcinoma 1 (2%) 1 (2%) Parathyroid Gland (49) (49) (48) (49) Carcinoma, Metastatic, Thyroid Gland 2 (4%) Pituitary Gland (50) (50) (49) (50) Adenoma 35 (70%) 27 (54%) 26 (53%) 32 (64%) Thyroid Gland (50) (50) (49) (50) C-Cell, Adenoma 3 (6%) 3 (6%) 3 (6%) 5 (10%) C-Cell, Adenoma, Multiple 1 (2%) C-Cell, Carcinoma 1 (2%) 1 (2%) 3 (6%) 3 (6%) Follicular Cell, Adenoma 1 (2%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Peritoneum (1) (2) (2) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (50) (49) (50) Preputial Gland (50) (50) (49) (50) Adenoma 1 (2%) Carcinoma 1 (2%) 2 (4%) 1 (2%) 2 (4%) Prostate (50) (50) (49) (50) Seminal Vesicle (50) (50) (49) (50) Testes (50) (50) (49) (50) Bilateral, Interstitial Cell, Adenoma 29 (58%) 31 (62%) 30 (61%) 32 (64%) Interstitial Cell, Adenoma 12 (24%) 14 (28%) 10 (20%) 10 (20%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (49) (50) Lymph Node (12) (7) (15) (6) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (14%) Lymph Node, Bronchial (24) (7) (9) (21) Carcinoma, Metastatic, Lung 1 (5%) Histiocytic Sarcoma, Metastatic, Skin 1 (14%) Lymph Node, Mandibular (1) (3) (3) (1) Carcinoma, Metastatic, Zymbal's Gland 1 (33%) Lymph Node, Mesenteric (50) (50) (49) (50) Lymph Node, Mediastinal (38) (41) (46) (45) Carcinoma, Metastatic, Lung 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Sarcoma, Metastatic, Heart 1 (2%) Spleen (50) (50) (49) (50) Thymus (47) (46) (46) (47) Sarcoma, Metastatic, Heart 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (49) (50) Carcinoma 2 (4%) 2 (4%) 1 (2%) Fibroadenoma 2 (4%) 2 (4%) 3 (6%) 3 (6%) Skin (50) (50) (49) (50) Basal Cell Adenoma 1 (2%) 3 (6%) Basal Cell Carcinoma 1 (2%) Keratoacanthoma 1 (2%) Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) Pinna, Neural Crest Tumor 1 (2%) Sebaceous Gland, Adenoma 1 (2%) Subcutaneous Tissue, Fibroma 2 (4%) 4 (8%) 2 (4%) 4 (8%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%) Subcutaneous Tissue, Lipoma 1 (2%) 2 (4%) 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) Subcutaneous Tissue, Schwannoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (49) (50) Mandible, Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Mandible, Osteosarcoma 1 (2%) Vertebra, Chordoma 1 (2%) Skeletal Muscle (2) (3) Carcinoma, Metastatic, Thyroid Gland 1 (50%) Sarcoma, Metastatic, Skin 1 (33%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (49) (50) Astrocytoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (49) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%) 2 (4%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%) 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Cholangiocarcinoma, Metastatic, Liver 1 (2%) Histiocytic Sarcoma, Metastatic, Skin 1 (2%) Osteosarcoma, Metastatic, Bone 1 (2%) Sarcoma, Metastatic, Heart 1 (2%) Pleura (49) (50) (49) (50) Sarcoma, Metastatic, Heart 1 (2%) Trachea (50) (49) (49) (50) Carcinoma, Metastatic, Thyroid Gland 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (50) (49) (49) (50) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Zymbal's Gland (44) (41) (39) (46) Carcinoma 1 (2%) 2 (5%) 2 (4%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (49) (50) Lipoma 1 (2%) Sarcoma, Metastatic, Heart 1 (2%) Stromal Nephroma 1 (2%) Cortex, Renal Tubule, Adenoma 1 (2%) 1 (2%) 2 (4%) 2 (4%) Cortex, Renal Tubule, Adenoma, Multiple 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (50) (49) (49) (50) Transitional Epithelium, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 33 (66%) 31 (62%) 35 (70%) 27 (54%) Mesothelioma Malignant 2 (4%) 2 (4%) 3 (6%) 4 (8%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 90004-07 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC PROPYLENE GLYCOL MONO-T-BUTYL ETHER Date: 11/14/01 Route: RESPIRATORY EXPOSURE WHOLE BODY Time: 08:44:36 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 75 PPM 300 PPM 1200 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 50 49 50 Total Primary Neoplasms 154 143 145 162 Total Animals with Benign Neoplasms 50 50 48 49 Total Benign Neoplasms 110 100 98 109 Total Animals with Malignant Neoplasms 35 34 40 40 Total Malignant Neoplasms 44 42 47 53 Total Animals with Metastatic Neoplasms 1 3 2 9 Total Metastatic Neoplasm 1 10 2 18 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 Total Uncertain Neoplasms 1 ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion b Primary tumors: all tumors except metastatic tumors Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------