TDMS Study 93005-03 Pathology Tables
NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 14:23:56 Facility: National Center for Toxicological Research Chemical CAS #: 569-64-2 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: 93005-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 14:23:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 48 48 48 48 Early Deaths Natural Death 1 3 1 6 Moribund Sacrifice 18 22 15 17 Survivors Terminal Sacrifice 29 23 32 25 Animals Examined Microscopically 48 48 48 48 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (47) (47) (48) (47) Polyp Adenomatous 1 (2%) Intestine Large, Rectum (48) (46) (48) (48) Polyp Adenomatous 1 (2%) Intestine Small, Ileum (47) (46) (48) (47) Liver (48) (48) (48) (48) Carcinoma, Metastatic, Uterus 1 (2%) Hepatocellular Carcinoma 1 (2%) Hepatocellular Adenoma 1 (2%) 3 (6%) 3 (6%) Hepatocellular Adenoma, Multiple 1 (2%) 1 (2%) Sarcoma, Metastatic, Ovary 1 (2%) Mesentery (9) (5) (2) (4) Carcinoma, Metastatic, Uterus 1 (20%) Sarcoma 1 (11%) Sarcoma, Metastatic, Ovary 1 (25%) Pancreas (48) (48) (48) (48) Carcinoma, Metastatic, Uterus 1 (2%) Salivary Glands (48) (47) (48) (48) Tongue (48) (48) (48) (48) Sarcoma, Metastatic, Ovary 1 (2%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 14:23:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (48) (48) (48) (48) Sarcoma, Metastatic, Ovary 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (48) (48) (48) (48) Adenoma 2 (4%) Pheochromocytoma Malignant, Metastatic, Adrenal Medulla 1 (2%) Sarcoma, Metastatic, Ovary 1 (2%) Adrenal Medulla (47) (47) (48) (48) Pheochromocytoma Malignant 1 (2%) Pheochromocytoma Benign 1 (2%) 1 (2%) Sarcoma, Metastatic, Ovary 1 (2%) Islets, Pancreatic (48) (48) (48) (48) Adenoma 2 (4%) 1 (2%) 1 (2%) Carcinoma 1 (2%) Pituitary Gland (48) (47) (46) (45) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Pars Distalis, Adenoma 26 (54%) 36 (77%) 32 (70%) 29 (64%) Pars Distalis, Carcinoma 1 (2%) Thyroid Gland (46) (48) (47) (46) Sarcoma, Metastatic, Ovary 1 (2%) C-Cell, Adenoma 4 (9%) 5 (10%) 3 (6%) 3 (7%) C-Cell, Carcinoma 3 (7%) 1 (2%) 2 (4%) 1 (2%) Follicular Cell, Adenoma 1 (2%) 1 (2%) Follicular Cell, Carcinoma 2 (4%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (48) (48) (47) (47) Adenoma 7 (15%) 5 (10%) 8 (17%) 8 (17%) Carcinoma 5 (10%) 1 (2%) 5 (11%) 4 (9%) Bilateral, Carcinoma 1 (2%) 1 (2%) 1 (2%) Ovary (48) (48) (47) (48) Page 3 NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 14:23:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - cont Carcinoma, Metastatic, Clitoral Gland 1 (2%) Granulosa Cell Tumor Malignant 1 (2%) Sarcoma 1 (2%) Uterus (48) (48) (48) (48) Polyp Stromal 14 (29%) 7 (15%) 5 (10%) 16 (33%) Sarcoma, Metastatic, Ovary 1 (2%) Sarcoma Stromal 2 (4%) 1 (2%) 1 (2%) Schwannoma Malignant 1 (2%) Endometrium, Adenoma 1 (2%) Endometrium, Carcinoma 1 (2%) Vagina (48) (48) (48) (48) Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (48) (48) (48) (48) Lymph Node (10) (7) (7) (5) Lymph Node, Mandibular (47) (46) (47) (48) Lymph Node, Mesenteric (47) (47) (48) (48) Spleen (48) (48) (48) (48) Carcinoma, Metastatic, Uterus 1 (2%) Hemangiosarcoma 1 (2%) Sarcoma, Metastatic, Ovary 1 (2%) Thymus (40) (42) (43) (40) Sarcoma, Metastatic, Ovary 1 (3%) Sarcoma, Metastatic, Uncertain Primary Site 1 (3%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (46) (48) (48) (48) Carcinoma 2 (4%) 2 (4%) 1 (2%) 5 (10%) Fibroadenoma 15 (33%) 13 (27%) 12 (25%) 9 (19%) Skin (48) (48) (48) (48) Basal Cell Adenoma 1 (2%) Keratoacanthoma 1 (2%) Squamous Cell Papilloma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) Subcutaneous Tissue, Sarcoma 2 (4%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 14:23:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (48) (48) (48) (48) Sarcoma 1 (2%) Skeletal Muscle (48) (48) (48) (48) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (48) (48) (48) (48) Oligodendroglioma Malignant 1 (2%) Ventricle, Carcinoma, Metastatic, Pituitary Gland 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (48) (48) (48) (48) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Carcinoma, Metastatic, Zymbal's Gland 1 (2%) Sarcoma, Metastatic, Mesentery 1 (2%) Sarcoma, Metastatic, Uncertain Primary Site 1 (2%) Sarcoma Stromal, Metastatic, Uterus 1 (2%) Mediastinum, Sarcoma, Metastatic, Ovary 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Pinna, Neural Crest Tumor 1 (100%) Eye (47) (48) (48) (48) Harderian Gland (47) (48) (48) (48) Adenoma 1 (2%) Zymbal's Gland (47) (48) (48) (46) Carcinoma 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (48) (48) (48) Urinary Bladder (47) (48) (47) (47) Sarcoma, Metastatic, Skin 1 (2%) Transitional Epithelium, Carcinoma 1 (2%) Page 5 NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 14:23:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(48) *(48) *(48) *(48) Leukemia Mononuclear 19 (40%) 17 (35%) 10 (21%) 1 (2%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 6 NTP Experiment-Test: 93005-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC MALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 14:23:56 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE 0 PPM 100 PPM 300 PPM 600 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 47 48 46 42 Total Primary Neoplasms 104 99 94 102 Total Animals with Benign Neoplasms 41 42 40 35 Total Benign Neoplasms 70 74 69 75 Total Animals with Malignant Neoplasms 29 24 21 23 Total Malignant Neoplasms 34 25 25 26 Total Animals with Metastatic Neoplasms 2 3 1 5 Total Metastatic Neoplasm 2 6 1 17 Total Animals with Malignant Neoplasms 1 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 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------