TDMS Study 93029-03 Pathology Tables
NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 Facility: National Center for Toxicological Research Chemical CAS #: 129-73-7 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: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 48 48 48 48 Early Deaths Moribund 12 11 12 10 Natural Death 3 1 1 4 Survivors Moribund 1 Terminal Sacrifice 33 36 35 33 Animals Examined Microscopically 48 48 48 48 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large (48) (48) (48) (48) Colon, Adenocarcinoma 1 (2%) Intestine Small (48) (48) (48) (48) Liver (48) (48) (48) (48) Hepatocellular Adenoma 1 (2%) 3 (6%) 3 (6%) Mesentery (8) (7) (1) (4) Sarcoma 1 (13%) Schwannoma Malignant, Metastatic, Uterus 1 (13%) Pancreas (48) (48) (47) (48) Schwannoma Malignant, Metastatic, Uterus 1 (2%) Acinar Cell, Adenoma 1 (2%) Salivary Glands (48) (48) (48) (48) Sarcoma 1 (2%) Parotid Gland, Adenoma 1 (2%) Stomach (48) (48) (48) (48) Tongue (48) (48) (48) (48) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (48) (48) (48) (48) Heart (48) (48) (48) (48) Endocardium, Schwannoma Malignant 1 (2%) Myocardium, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 2 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (47) (48) (47) (48) Medulla, Pheochromocytoma Malignant 1 (2%) Medulla, Pheochromocytoma Benign 1 (2%) Islets, Pancreatic (48) (48) (47) (48) Pituitary Gland (47) (47) (45) (46) Pars Distalis, Adenoma 26 (55%) 23 (49%) 17 (38%) 20 (43%) Thyroid Gland (46) (46) (47) (48) Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%) Bilateral, C-Cell, Carcinoma 1 (2%) C-Cell, Adenoma 4 (9%) 7 (15%) 4 (9%) 4 (8%) C-Cell, Carcinoma 1 (2%) Follicular Cell, Adenoma 1 (2%) Follicular Cell, Carcinoma 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) Schwannoma Malignant, Metastatic, Uterus 1 (100%) Abdominal, Lipoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (47) (46) (47) Adenoma 7 (15%) 8 (17%) 3 (7%) 6 (13%) Carcinoma 2 (4%) 1 (2%) 2 (4%) 2 (4%) Ovary (48) (48) (48) (48) Oviduct (1) Leiomyoma 1 (100%) Uterus (48) (48) (48) (48) Leiomyoma 1 (2%) 1 (2%) Polyp Stromal 9 (19%) 10 (21%) 16 (33%) 16 (33%) Sarcoma Stromal 1 (2%) 1 (2%) Schwannoma Malignant 1 (2%) 1 (2%) Bilateral, Polyp Stromal 1 (2%) 2 (4%) 3 (6%) 1 (2%) Cervix, Squamous Cell Papilloma 1 (2%) Endometrium, Adenoma 1 (2%) 1 (2%) Endometrium, Carcinoma 1 (2%) Vagina (48) (48) (48) (48) Sarcoma 1 (2%) Schwannoma Malignant 1 (2%) Page 3 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (48) (48) (48) (48) Mesenteric, Schwannoma Malignant, Metastatic, Uterus 1 (2%) Spleen (48) (48) (48) (48) Thymus (41) (47) (44) (42) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (46) (48) (48) Adenoma 1 (2%) 1 (2%) 2 (4%) Carcinoma 1 (2%) 2 (4%) 2 (4%) Fibroadenoma 20 (42%) 12 (26%) 9 (19%) 13 (27%) Fibroadenoma, Multiple 3 (6%) Skin (48) (48) (48) (48) Basal Cell Adenoma 1 (2%) 1 (2%) Basal Cell Carcinoma 1 (2%) Fibroma 1 (2%) 1 (2%) Fibrous Histiocytoma 1 (2%) Keratoacanthoma 1 (2%) 1 (2%) Sarcoma 2 (4%) Squamous Cell Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (48) (48) (48) (48) Cranial Nerve, Schwannoma Malignant 1 (2%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (48) (48) (48) (48) Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%) 3 (6%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Nose (48) (48) (48) (48) Trachea (48) (48) (48) (48) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) Pinna, Neural Crest Tumor 1 (100%) Eye (48) (48) (48) (48) Lids, Sarcoma 1 (2%) Harderian Gland (48) (48) (48) (48) Zymbal's Gland (46) (47) (47) (46) Adenoma 2 (4%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (48) (48) (48) Hemangiosarcoma 1 (2%) Mesenchymal Tumor Benign 1 (2%) Sarcoma 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (47) (47) (48) (48) Transitional Epithelium, Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(48) *(48) *(48) *(48) Hemangiosarcoma 1 (2%) Leukemia Mononuclear 17 (35%) 8 (17%) 5 (10%) 8 (17%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR FEMALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 46 46 42 43 Total Primary Neoplasms 99 92 84 90 Total Animals with Benign Neoplasms 41 43 37 38 Total Benign Neoplasms 74 73 63 75 Total Animals with Malignant Neoplasms 21 16 19 15 Total Malignant Neoplasms 25 18 21 15 Total Animals with Metastatic Neoplasms 1 1 Total Metastatic Neoplasm 4 1 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: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 48 48 48 48 Early Deaths Moribund 20 12 11 10 Natural Death 4 5 3 7 Survivors Natural Death 1 1 Terminal Sacrifice 23 29 34 30 Wrong Sex 1 1 Animals Examined Microscopically 48 47 48 47 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large (48) (47) (48) (47) Colon, Adenoma 1 (2%) Rectum, Sarcoma, Metastatic, Skin 1 (2%) Intestine Small (47) (47) (48) (47) Ileum, Leiomyoma 1 (2%) 1 (2%) Jejunum, Leiomyoma 1 (2%) Liver (48) (47) (48) (47) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Hepatocellular Adenoma 2 (4%) 2 (4%) 3 (6%) 2 (4%) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Mesentery (5) (3) (6) (3) Pancreas (48) (47) (48) (47) Sarcoma, Metastatic, Skin 1 (2%) Acinar Cell, Adenocarcinoma 1 (2%) Salivary Glands (48) (47) (48) (47) Fibrous Histiocytoma 1 (2%) Histiocytic Sarcoma 1 (2%) Stomach (48) (47) (47) (47) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (48) (47) (48) (47) Heart (48) (47) (48) (47) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) Page 7 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland (48) (47) (48) (47) Bilateral, Medulla, Pheochromocytoma Benign 1 (2%) Cortex, Adenoma 1 (2%) 1 (2%) 1 (2%) Medulla, Pheochromocytoma Malignant 2 (4%) 3 (6%) Medulla, Pheochromocytoma Complex 1 (2%) Medulla, Pheochromocytoma Benign 3 (6%) 5 (11%) 2 (4%) 3 (6%) Islets, Pancreatic (48) (47) (48) (47) Adenoma 5 (10%) 2 (4%) 1 (2%) 4 (9%) Pituitary Gland (45) (46) (48) (45) Craniopharyngioma 1 (2%) Pars Distalis, Adenoma 30 (67%) 19 (41%) 21 (44%) 13 (29%) Thyroid Gland (47) (47) (48) (46) Fibrous Histiocytoma 1 (2%) Bilateral, Follicular Cell, Carcinoma 1 (2%) C-Cell, Adenoma 6 (13%) 7 (15%) 7 (15%) 4 (9%) C-Cell, Carcinoma 1 (2%) 2 (4%) Follicular Cell, Adenoma 2 (4%) 1 (2%) Follicular Cell, Carcinoma 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) (1) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (48) (47) (48) (47) Sarcoma, Metastatic, Skin 2 (4%) Preputial Gland (48) (47) (48) (47) Adenoma 5 (10%) 2 (4%) 7 (15%) 3 (6%) Carcinoma 6 (13%) 4 (8%) 9 (19%) Sarcoma, Metastatic, Skin 2 (4%) Squamous Cell Papilloma 1 (2%) Prostate (48) (47) (48) (47) Testes (48) (47) (48) (47) Bilateral, Interstitial Cell, Adenoma 22 (46%) 30 (64%) 38 (79%) 39 (83%) Interstitial Cell, Adenoma 15 (31%) 12 (26%) 5 (10%) 6 (13%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (48) (47) (48) (47) Lymph Node (48) (47) (48) (47) Spleen (48) (47) (48) (47) Adenocarcinoma, Metastatic, Pancreas 1 (2%) Thymus (43) (42) (43) (42) Fibrous Histiocytoma 1 (2%) Histiocytic Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (43) (41) (46) (41) Carcinoma 1 (2%) Fibroadenoma 1 (2%) 2 (5%) 1 (2%) 4 (10%) Skin (48) (47) (47) (47) Basal Cell Adenoma 1 (2%) Basal Cell Carcinoma 1 (2%) Fibroma 4 (8%) 1 (2%) 1 (2%) 5 (11%) Fibrous Histiocytoma 1 (2%) 1 (2%) 1 (2%) Keratoacanthoma 2 (4%) 3 (6%) 2 (4%) Lipoma 3 (6%) 1 (2%) Sarcoma 3 (6%) 4 (9%) Squamous Cell Carcinoma 1 (2%) Squamous Cell Papilloma 1 (2%) Face, Squamous Cell Papilloma 1 (2%) Sebaceous Gland, Adenoma 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (48) (47) (48) (47) Femur, Sarcoma, Metastatic, Skin 1 (2%) Skeletal Muscle (48) (47) (48) (47) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (48) (47) (48) (47) Cerebrum, Astrocytoma Malignant 1 (2%) Spinal Cord (48) (47) (48) (47) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (48) (47) (48) (47) Alveolar/Bronchiolar Adenoma 1 (2%) 3 (6%) 4 (9%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Fibrous Histiocytoma, Metastatic, Skin 1 (2%) Histiocytic Sarcoma 1 (2%) Sarcoma, Metastatic, Skin 1 (2%) 1 (2%) Squamous Cell Carcinoma, Metastatic, Preputial Gland 1 (2%) Alveolar/Bronchiolar, Adenoma 1 (2%) Nose (48) (47) (48) (47) Trachea (48) (47) (48) (47) Fibrous Histiocytoma 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) (2) Pinna, Neural Crest Tumor 1 (100%) 1 (50%) Eye (48) (47) (48) (47) Lids, Sarcoma 1 (2%) Harderian Gland (48) (47) (48) (47) Zymbal's Gland (46) (43) (47) (47) Carcinoma 1 (2%) 1 (2%) Squamous Cell Carcinoma 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (48) (47) (48) (47) Histiocytic Sarcoma 1 (2%) Urinary Bladder (48) (47) (48) (47) Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(48) *(47) *(48) *(47) Leukemia Mononuclear 29 (60%) 16 (34%) 19 (40%) 7 (15%) Mesothelioma Malignant 2 (4%) 1 (2%) 1 (2%) * Number of animals with any tissue examined microscopically Page 10 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS - cont Multiple Organs *(48) *(47) *(48) *(47) ____________________________________________________________________________________________________________________________________ Page 11 NTP Experiment-Test: 93029-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC LEUKOMALACHITE GREEN Date: 06/18/03 Route: DOSED FEED Time: 15:01:05 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS-NCTR MALE 0 PPM 91 PPM 272 PPM 543 PPM ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 48 47 47 47 Total Primary Neoplasms 140 129 122 128 Total Animals with Benign Neoplasms 45 47 47 47 Total Benign Neoplasms 98 98 92 94 Total Animals with Malignant Neoplasms 34 23 25 26 Total Malignant Neoplasms 41 31 29 34 Total Animals with Metastatic Neoplasms 3 1 5 Total Metastatic Neoplasm 10 1 6 Total Animals with Malignant Neoplasms Uncertain Primary Site Total Animals with Neoplasms Uncertain- Benign or Malignant 1 1 Total Uncertain Neoplasms 1 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 ---------- ------------------------------------------------------------