TDMS Study 05706-02 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID NTP Experiment-Test: 05706-02 Report: PEIRPT05 Study Type: CHRONIC Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 Facility: International Research and Development Corp. Chemical CAS #: 81-11-8 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: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 Scheduled Sacrifice 10 10 10 Early Deaths Moribund 15 14 16 Dead 5 3 1 Survivors Terminal Sacrifice 30 32 33 Dead 1 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Cecum (49) (8) (50) Intestine Large, Colon (49) (8) (50) Intestine Large, Rectum (49) (8) (50) Intestine Small, Ileum (49) (8) (50) Intestine Small, Jejunum (49) (8) (50) Liver (50) (42) (50) Neoplastic Nodule 3 (6%) 1 (2%) Mesentery (2) (2) (3) Pancreas (49) (8) (50) Salivary Glands (49) (8) (50) Stomach, Forestomach (50) (10) (50) Stomach, Glandular (49) (10) (50) Leiomyosarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (8) (50) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (50) (49) Adenoma 2 (4%) Adrenal Gland, Medulla (49) (50) (49) Pheochromocytoma Malignant 2 (4%) Pheochromocytoma Benign 2 (4%) 4 (8%) 5 (10%) Islets, Pancreatic (49) (8) (50) Adenoma 1 (2%) Pituitary Gland (50) (37) (49) Page 2 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - cont Pars Distalis, Adenoma 15 (30%) 20 (54%) 13 (27%) Pars Distalis, Adenoma, Multiple 1 (2%) Thyroid Gland (49) (10) (49) C-Cell, Adenoma 2 (4%) 3 (6%) C-Cell, Carcinoma 2 (4%) 2 (20%) 5 (10%) Follicular Cell, Adenoma 1 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (13) (46) Adenoma 3 (6%) 5 (38%) 4 (9%) Bilateral, Adenoma 1 (2%) Ovary (50) (8) (50) Granulosa Cell Tumor Benign 2 (4%) Uterus (50) (22) (50) Leiomyosarcoma 1 (5%) Cervix, Carcinoma 1 (2%) Cervix, Leiomyosarcoma 1 (2%) Cervix, Squamous Cell Carcinoma 1 (5%) Endometrium, Polyp Stromal 9 (18%) 8 (36%) 11 (22%) Endometrium, Sarcoma Stromal 1 (5%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (8) (50) Lymph Node (50) (27) (49) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (2%) Lymph Node, Mesenteric (50) (8) (49) Axillary, Mediastinal, Adenocarcinoma, Metastatic, Skin 1 (2%) Spleen (49) (22) (50) Thymus (48) (8) (49) Thymoma Benign 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 3 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (47) (50) Adenocarcinoma 1 (2%) 2 (4%) 3 (6%) Adenoma 2 (4%) 1 (2%) 2 (4%) Fibroadenoma 9 (18%) 17 (36%) 19 (38%) Fibroadenoma, Multiple 2 (4%) 4 (9%) 2 (4%) Skin (50) (8) (50) Sebaceous Gland, Adenocarcinoma 1 (2%) Subcutaneous Tissue, Fibroma 1 (2%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 2 (4%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Schwannoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (8) (50) Astrocytoma Benign 1 (13%) Glioma Benign 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (33) (38) Lung (50) (29) (50) Adenocarcinoma, Metastatic, Skin 1 (2%) Alveolar/Bronchiolar Adenoma 1 (3%) 1 (2%) Nose (49) (8) (50) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) (5) (2) Zymbal's Gland (2) (1) Squamous Cell Carcinoma 2 (100%) ____________________________________________________________________________________________________________________________________ Page 4 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Renal Tubule, Adenoma 1 (2%) Renal Tubule, Carcinoma 1 (2%) Urinary Bladder (50) (9) (50) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Leukemia Mononuclear 16 (32%) 14 (28%) 15 (30%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 5 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 45 44 50 Total Primary Neoplasms 77 86 97 Total Animals with Benign Neoplasms 32 36 44 Total Benign Neoplasms 52 62 72 Total Animals with Malignant Neoplasms 23 21 22 Total Malignant Neoplasms 25 24 25 Total Animals with Metastatic Neoplasms 2 Total Metastatic Neoplasm 3 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: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially in Study 60 60 60 Scheduled Sacrifice 10 10 10 Early Deaths Moribund 21 24 20 Dead 7 6 6 Survivors Terminal Sacrifice 22 20 24 Animals Examined Microscopically 50 50 50 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (47) (14) (49) Intestine Large, Rectum (47) (14) (48) Intestine Small, Duodenum (48) (12) (49) Intestine Small, Ileum (48) (12) (48) Adenoma, Papillary 1 (2%) Intestine Small, Jejunum (47) (11) (48) Liver (50) (49) (50) Neoplastic Nodule 1 (2%) 1 (2%) 4 (8%) Neoplastic Nodule, Multiple 1 (2%) Neuroblastoma Malignant, Metastatic, Adrenal Gland 1 (2%) Mesentery (5) (2) (5) Fibrous Histiocytoma 1 (20%) Pancreas (49) (16) (49) Sarcoma, Metastatic, Tissue NOS 1 (6%) Salivary Glands (50) (14) (50) Stomach, Forestomach (49) (21) (49) Sarcoma, Metastatic, Tissue NOS 1 (5%) Squamous Cell Papilloma 1 (2%) Stomach, Glandular (48) (21) (50) Tongue (3) Squamous Cell Papilloma 1 (33%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (50) (20) (50) Sarcoma, Metastatic, Skin 1 (5%) 1 (2%) ____________________________________________________________________________________________________________________________________ Page 7 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (49) (50) Adrenal Gland, Medulla (48) (50) (50) Pheochromocytoma Malignant 2 (4%) 3 (6%) 4 (8%) Pheochromocytoma Malignant, Multiple 1 (2%) 4 (8%) Pheochromocytoma Complex 1 (2%) Pheochromocytoma Benign 12 (25%) 14 (28%) 14 (28%) Pheochromocytoma Benign, Multiple 4 (8%) 4 (8%) 5 (10%) Islets, Pancreatic (49) (16) (49) Adenoma 2 (4%) Carcinoma 1 (2%) 2 (4%) Parathyroid Gland (49) (15) (45) Adenoma 1 (2%) Pituitary Gland (50) (49) (50) Pars Distalis, Adenoma 16 (32%) 8 (16%) 10 (20%) Pars Distalis, Adenoma, Multiple 1 (2%) Thyroid Gland (49) (18) (50) C-Cell, Adenoma 2 (4%) 1 (6%) C-Cell, Carcinoma 2 (4%) 1 (6%) 3 (6%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM Tissue NOS (1) Sarcoma 1 (100%) ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (50) (13) (50) Preputial Gland (50) (20) (49) Adenoma 8 (16%) 4 (20%) 4 (8%) Carcinoma 1 (2%) 2 (10%) 1 (2%) Fibrosarcoma 1 (2%) Squamous Cell Papilloma 1 (2%) Bilateral, Carcinoma 2 (4%) 1 (5%) 3 (6%) Prostate (50) (14) (49) Seminal Vesicle (48) (37) (47) Testes (50) (50) (50) Interstitial Cell, Adenoma 4 (8%) 9 (18%) 3 (6%) Interstitial Cell, Adenoma, Multiple 38 (76%) 31 (62%) 43 (86%) ____________________________________________________________________________________________________________________________________ Page 8 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (14) (50) Neuroblastoma Malignant, Metastatic, Adrenal Gland 1 (2%) Lymph Node (50) (33) (50) Deep Cervical, Carcinoma, Metastatic, Thyroid Gland 1 (2%) Inguinal, Renal, Iliac, Bronchial, Mediastinal, Sarcoma, Metastatic, Skin 1 (2%) Mediastinal, Alveolar/Bronchiolar Carcinoma, Metastatic, Lung 1 (3%) Lymph Node, Mesenteric (50) (18) (50) Spleen (49) (49) (50) Histiocytic Sarcoma 1 (2%) Neuroblastoma Malignant, Metastatic, Adrenal Gland 1 (2%) Thymus (50) (14) (46) Sarcoma, Metastatic, Skin 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (18) (50) Adenocarcinoma 1 (6%) Fibroadenoma 3 (6%) 2 (11%) 4 (8%) Skin (49) (21) (50) Keratoacanthoma 2 (4%) 2 (10%) 2 (4%) Squamous Cell Carcinoma 1 (2%) 1 (5%) Squamous Cell Papilloma 1 (2%) 1 (2%) Trichoepithelioma 2 (4%) Sebaceous Gland, Adenoma 1 (5%) Subcutaneous Tissue, Fibroma 1 (5%) 1 (2%) Subcutaneous Tissue, Fibrosarcoma 1 (2%) 2 (4%) Subcutaneous Tissue, Lipoma 1 (2%) Subcutaneous Tissue, Sarcoma 2 (10%) 1 (2%) Subcutaneous Tissue, Schwannoma Benign 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Skeletal Muscle (1) (1) Diaphragm, Sarcoma, Metastatic, Tissue NOS 1 (100%) ____________________________________________________________________________________________________________________________________ Page 9 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (13) (50) Astrocytoma Malignant 1 (2%) Sarcoma 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (26) (27) Carcinoma, Metastatic, Thyroid Gland 1 (4%) Lung (50) (30) (50) Alveolar/Bronchiolar Adenoma 1 (2%) 1 (3%) 2 (4%) Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (3%) Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%) Carcinoma, Metastatic, Preputial Gland 1 (3%) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Neuroblastoma Malignant, Metastatic, Adrenal Gland 1 (2%) Sarcoma, Metastatic, Skin 1 (3%) 1 (2%) Squamous Cell Carcinoma, Metastatic, Zymbal's Gland 1 (3%) Mediastinum, Alveolar/Bronchiolar Carcinoma 1 (2%) Mediastinum, Hemangiosarcoma 1 (3%) Nose (49) (14) (50) Trachea (50) (14) (50) Carcinoma, Metastatic, Thyroid Gland 1 (2%) Sarcoma, Metastatic, Skin 1 (7%) 1 (2%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Ear (1) External Ear, Squamous Cell Carcinoma 1 (100%) Zymbal's Gland (1) (1) Adenoma 1 (100%) Squamous Cell Carcinoma 1 (100%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (45) (50) Renal Tubule, Adenoma 1 (2%) Urinary Bladder (50) (14) (49) Page 10 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - cont Transitional Epithelium, Papilloma 1 (2%) ____________________________________________________________________________________________________________________________________ SYSTEMIC LESIONS Multiple Organs *(50) *(50) *(50) Histiocytic Sarcoma 1 (2%) Leukemia Mononuclear 23 (46%) 29 (58%) 28 (56%) Mesothelioma Benign 1 (2%) Mesothelioma Malignant 3 (6%) 1 (2%) 3 (6%) ____________________________________________________________________________________________________________________________________ * Number of animals with any tissue examined microscopically Page 11 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:57 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ TUMOR SUMMARY Total Animals with Primary Neoplasms (b) 50 50 50 Total Primary Neoplasms 136 127 161 Total Animals with Benign Neoplasms 47 44 48 Total Benign Neoplasms 97 80 104 Total Animals with Malignant Neoplasms 32 38 42 Total Malignant Neoplasms 39 47 57 Total Animals with Metastatic Neoplasms 1 4 2 Total Metastatic Neoplasm 4 9 9 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 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------