TDMS Study 05109-11 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) TRIETHANOLAMINE NTP Experiment-Test: 05109-11 Report: PEIRPT05 Study Type: CHRONIC Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 Facility: Battelle Columbus Laboratory Chemical CAS #: 102-71-6 Lock Date: 07/29/92 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: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 14 17 13 15 Moribund Sacrifice 11 4 12 17 Survivors Natural Death 1 Terminal Sacrifice 25 29 25 17 Animals Examined Microscopically 60 60 60 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Esophagus (60) (60) (60) (60) Periesophageal Tissue, Lipoma 1 (2%) Liver (60) (60) (60) (60) Hepatocellular Adenoma 1 (2%) Mesentery (3) (2) (2) (2) Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (50%) Pancreas (60) (60) (60) (60) Stomach, Forestomach (60) (60) (60) (60) Squamous Cell Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (60) (60) (60) (60) Schwannoma Benign 1 (2%) Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (60) (60) Adenoma 1 (2%) 1 (2%) Adrenal Medulla (60) (60) (60) (59) Pheochromocytoma Benign 1 (2%) 1 (2%) Bilateral, Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (60) (60) (60) (60) Adenoma 2 (3%) 2 (3%) Carcinoma 1 (2%) Parathyroid Gland (51) (57) (57) (51) Adenoma 1 (2%) Page 2 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pituitary Gland (60) (60) (60) (60) Pars Distalis, Adenoma 32 (53%) 26 (43%) 31 (52%) 27 (45%) Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%) Thyroid Gland (60) (60) (60) (59) C-Cell, Adenoma 1 (2%) 2 (3%) 2 (3%) 5 (8%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 2 (3%) 1 (2%) 2 (3%) 2 (3%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (58) (59) (60) (60) Adenoma 2 (3%) 6 (10%) 2 (3%) 2 (3%) Carcinoma 1 (2%) Bilateral, Carcinoma 1 (2%) Ovary (60) (60) (60) (60) Granulosa Cell Tumor Malignant 1 (2%) Uterus (60) (60) (60) (60) Leiomyoma 1 (2%) Polyp Stromal 4 (7%) 2 (3%) 8 (13%) 7 (12%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (60) (60) Lymph Node (6) (5) (6) (3) Mediastinal, Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (33%) Mediastinal, Schwannoma Malignant, Metastatic, Heart 1 (20%) Lymph Node, Mandibular (59) (60) (60) (60) Lymph Node, Mesenteric (60) (60) (59) (60) Spleen (60) (60) (60) (60) Thymus (59) (57) (57) (58) Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (2%) Thymoma Benign 1 (2%) Thymoma Malignant 1 (2%) Mediastinum, Schwannoma Malignant, Metastatic, Heart 1 (2%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (60) (60) (60) (60) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) Fibroadenoma 12 (20%) 13 (22%) 7 (12%) 6 (10%) Fibroadenoma, Multiple 1 (2%) 3 (5%) 2 (3%) Skin (60) (60) (60) (60) Face, Squamous Cell Papilloma 1 (2%) Inguinal, Keratoacanthoma 1 (2%) Subcutaneous Tissue, Neurofibrosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (2) Hemangiosarcoma 1 (100%) Rhabdomyosarcoma 1 (50%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (60) (60) Medulloblastoma NOS 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (60) (60) Mediastinum, Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (2%) Nose (60) (60) (60) (60) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) (1) Middle Ear, Carcinoma, Metastatic, Zymbal's Gland 1 (100%) Pinna, Fibrosarcoma 1 (50%) Zymbal's Gland (1) (1) (1) Carcinoma 1 (100%) 1 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (60) (60) Renal Tubule, Adenoma 1 (2%) 1 (2%) Urinary Bladder (59) (60) (60) (60) Leiomyoma 1 (2%) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(60) *(60) Leukemia Mononuclear 13 (22%) 14 (23%) 13 (22%) 16 (27%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 MG/KG 63 MG/KG 125 250 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 44 47 44 Total Primary Neoplasms 79 79 77 76 Total Animals with Benign Neoplasms 45 39 42 37 Total Benign Neoplasms 59 61 62 55 Total Animals with Malignant Neoplasms 17 17 13 18 Total Malignant Neoplasms 20 18 15 20 Total Animals with Metastatic Neoplasms 1 2 Total Metastatic Neoplasm 2 5 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: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 59 60 Scheduled Sacrifice 10 10 10 10 Early Deaths Natural Death 9 12 6 8 Moribund Sacrifice 18 27 25 23 Accidently Killed 2 Survivors Terminal Sacrifice 21 11 18 19 Animals Examined Microscopically 60 60 59 60 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (60) (60) (59) (60) Leiomyosarcoma 1 (2%) Intestine Small, Duodenum (60) (60) (59) (60) Leiomyosarcoma, Metastatic, Intestine Large, Colon 1 (2%) Leiomyosarcoma, Metastatic, Stomach, Glandular 1 (2%) Intestine Small, Jejunum (60) (60) (59) (60) Fibrous Histiocytoma, Metastatic, Spleen 1 (2%) Mast Cell Tumor Malignant 1 (2%) Intestine Small, Ileum (60) (60) (59) (60) Fibrous Histiocytoma, Metastatic, Spleen 1 (2%) Liver (60) (60) (59) (60) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 3 (5%) 1 (2%) Leiomyosarcoma, Metastatic, Intestine Large, Colon 1 (2%) Leiomyosarcoma, Metastatic, Stomach, Glandular 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (2%) Mesentery (9) (10) (11) (5) Leiomyosarcoma, Metastatic, Intestine Large, Colon 1 (10%) Leiomyosarcoma, Metastatic, Stomach, Glandular 1 (9%) Pancreas (60) (60) (59) (60) Leiomyosarcoma, Metastatic, Intestine Large, Colon 1 (2%) Leiomyosarcoma, Metastatic, Stomach, Glandular 1 (2%) Page 7 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - cont Salivary Glands (60) (60) (58) (60) Neurofibrosarcoma, Metastatic, Skin 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (2%) Stomach, Forestomach (60) (60) (59) (60) Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%) Stomach, Glandular (60) (60) (59) (60) Leiomyosarcoma 1 (2%) Leiomyosarcoma, Metastatic, Intestine Large, Colon 1 (2%) Tongue (1) Squamous Cell Papilloma 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (60) (60) (59) (59) Heart (60) (60) (59) (60) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (60) (60) (59) (60) Adrenal Medulla (60) (60) (59) (60) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 2 (3%) 8 (13%) 5 (8%) 3 (5%) Bilateral, Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (60) (60) (59) (60) Adenoma 1 (2%) 3 (5%) 3 (5%) 5 (8%) Parathyroid Gland (55) (57) (53) (56) Adenoma 1 (2%) Pituitary Gland (60) (60) (58) (60) Pars Distalis, Adenoma 37 (62%) 40 (67%) 35 (60%) 39 (65%) Pars Distalis, Adenoma, Multiple 1 (2%) 1 (2%) 2 (3%) 4 (7%) Thyroid Gland (60) (60) (59) (60) Neurofibrosarcoma, Metastatic, Skin 1 (2%) Bilateral, C-Cell, Adenoma 1 (2%) C-Cell, Adenoma 6 (10%) 4 (7%) 8 (14%) 6 (10%) C-Cell, Carcinoma 1 (2%) 1 (2%) Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (60) (60) (59) (60) Preputial Gland (60) (60) (58) (60) Adenoma 1 (2%) 1 (2%) Carcinoma 1 (2%) 1 (2%) Fibrosarcoma 1 (2%) Prostate (60) (59) (59) (60) Adenocarcinoma 1 (2%) 1 (2%) Sarcoma 1 (2%) Seminal Vesicle (60) (60) (59) (60) Testes (60) (60) (59) (60) Bilateral, Interstitial Cell, Adenoma 16 (27%) 14 (23%) 16 (27%) 9 (15%) Interstitial Cell, Adenoma 18 (30%) 26 (43%) 21 (36%) 20 (33%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (60) (60) (59) (60) Lymph Node (15) (10) (16) (9) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (6%) Lymph Node, Mandibular (60) (60) (59) (60) Schwannoma Malignant, Metastatic, Skin 1 (2%) Lymph Node, Mesenteric (60) (60) (59) (59) Spleen (60) (60) (59) (60) Fibrous Histiocytoma 1 (2%) Thymus (56) (59) (58) (59) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (58) (53) (54) (54) Carcinoma 1 (2%) 1 (2%) Fibroadenoma 1 (2%) Skin (60) (60) (59) (60) Basal Cell Adenoma 1 (2%) Keratoacanthoma 1 (2%) Abdominal, Ventral, Keratoacanthoma 1 (2%) Dorsal, Keratoacanthoma 1 (2%) Face, Basosquamous Tumor Malignant 1 (2%) Face, Squamous Cell Papilloma 2 (3%) 1 (2%) Head, Basosquamous Tumor Benign 1 (2%) Hindlimb, Subcutaneous Tissue, Fibroma 1 (2%) Inguinal, Keratoacanthoma 1 (2%) Inguinal, Subcutaneous Tissue, Fibrosarcoma 1 (2%) Inguinal, Subcutaneous Tissue, Sarcoma 1 (2%) Neck, Subcutaneous Tissue, Schwannoma Page 9 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM - cont Malignant 1 (2%) Pinna, Sarcoma 1 (2%) Pinna, Squamous Cell Papilloma 1 (2%) Site of Application-Mass, Basal Cell Adenoma 1 (2%) Site of Application-Mass, Keratoacanthoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrous Histiocytoma, Metastatic, Spleen 1 (2%) Subcutaneous Tissue, Liposarcoma 1 (2%) Subcutaneous Tissue, Neurofibrosarcoma 1 (2%) Subcutaneous Tissue, Sarcoma 1 (2%) Subcutaneous Tissue, Ventral, Fibroma 1 (2%) Tail, Fibrosarcoma 1 (2%) Thoracic, Keratoacanthoma 2 (3%) 1 (2%) Thoracic, Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) Ventral, Keratoacanthoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) (1) (1) Neurofibrosarcoma, Metastatic, Skin 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (60) (60) (58) (60) Astrocytoma NOS 1 (2%) Spinal Cord (2) (2) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (60) (60) (59) (60) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Carcinoma, Metastatic, Uncertain Primary Site 1 (2%) Schwannoma Malignant, Metastatic, Skin 1 (2%) Nose (60) (60) (59) (60) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) (2) (1) Zymbal's Gland (2) (2) (1) Carcinoma 2 (100%) 1 (50%) 1 (100%) ____________________________________________________________________________________________________________________________________ Page 10 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (60) (60) (59) (60) Hemangiosarcoma 1 (2%) Leiomyosarcoma, Metastatic, Intestine Large, Colon 1 (2%) Renal Tubule, Adenoma 1 (2%) 4 (7%) 2 (3%) Urinary Bladder (60) (60) (58) (59) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(60) *(60) *(59) *(60) Leukemia Mononuclear 25 (42%) 16 (27%) 21 (36%) 22 (37%) Mesothelioma NOS 3 (5%) 2 (3%) 2 (3%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 05109-11 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC TRIETHANOLAMINE Date: 05/19/95 Route: DERMAL,SOLUTION Time: 23:24:43 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE 0 MG/KG 32 MG/KG 63 MG/KG 125 MG/KG ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 53 58 57 55 Total Primary Neoplasms 134 131 132 124 Total Animals with Benign Neoplasms 49 58 56 53 Total Benign Neoplasms 100 101 102 94 Total Animals with Malignant Neoplasms 27 23 27 26 Total Malignant Neoplasms 31 30 28 27 Total Animals with Metastatic Neoplasms 5 2 1 Total Metastatic Neoplasm 15 5 3 Total Animals with Malignant Neoplasms 1 Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 3 2 3 Total Uncertain Neoplasms 16 6 12 ____________________________________________________________________________________________________________________________________ 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 ---------- ------------------------------------------------------------