TDMS Study 05706-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID NTP Experiment-Test: 05706-02 Report: PEIRPT03 Study Type: CHRONIC Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 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 NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ 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) Parasite Metazoan 1 (2%) Intestine Large, Colon (49) (8) (50) Mineralization 1 (13%) Parasite Metazoan 4 (8%) Intestine Large, Rectum (49) (8) (50) Mineralization 1 (13%) Parasite Metazoan 1 (2%) Liver (50) (42) (50) Angiectasis 1 (2%) 1 (2%) 7 (14%) Congestion 2 (4%) 3 (7%) Cytologic Alterations 1 (2%) 3 (7%) 3 (6%) Cytologic Alterations, Multiple 23 (46%) 12 (29%) 22 (44%) Fibrosis, Focal 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) 1 (2%) Hepatodiaphragmatic Nodule 16 (32%) 10 (24%) 8 (16%) Hyperplasia, Focal 5 (10%) 4 (10%) 4 (8%) Hyperplasia, Multifocal 2 (5%) Inflammation, Chronic 13 (26%) 12 (29%) 13 (26%) Mitotic Alteration 1 (2%) Necrosis, Multifocal 1 (2%) Pigmentation 1 (2%) Thrombosis 1 (2%) Vacuolization Cytoplasmic 1 (2%) 1 (2%) Bile Duct, Hyperplasia 19 (38%) 14 (33%) 16 (32%) Centrilobular, Necrosis 1 (2%) 2 (5%) 1 (2%) Centrilobular, Vacuolization Cytoplasmic 5 (10%) 1 (2%) 4 (8%) Mesentery (2) (2) (3) Hyperplasia, Lymphoid 1 (33%) Fat, Necrosis 2 (100%) 2 (100%) 2 (67%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Pancreas (49) (8) (50) Inflammation, Chronic 1 (2%) Acinus, Atrophy, Diffuse 1 (2%) Acinus, Atrophy, Focal 13 (27%) 1 (13%) 23 (46%) Acinus, Hyperplasia, Focal 1 (2%) Artery, Inflammation, Chronic 2 (4%) Artery, Inflammation, Subacute 1 (2%) Pharynx (1) Palate, Inflammation, Acute 1 (100%) Salivary Glands (49) (8) (50) Atrophy, Focal 1 (2%) Cyst 1 (2%) Stomach, Forestomach (50) (10) (50) Inflammation, Acute 2 (4%) 1 (2%) Inflammation, Chronic 1 (10%) Ulcer 1 (10%) 4 (8%) Epithelium, Hyperplasia 2 (4%) 1 (2%) Stomach, Glandular (49) (10) (50) Edema 1 (2%) Erosion 1 (2%) 2 (20%) 1 (2%) Inflammation, Acute 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (10%) Pigmentation 2 (4%) Ulcer 2 (4%) Tongue (2) Epithelium, Hyperplasia 2 (100%) Tooth (1) Inflammation, Chronic Active 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) (1) Aorta, Mineralization 1 (100%) Artery, Inflammation, Chronic 1 (100%) Heart (50) (8) (50) Cardiomyopathy 25 (50%) 4 (50%) 28 (56%) Mineralization 1 (2%) 1 (13%) Atrium, Thrombosis 2 (4%) 4 (8%) Myocardium, Necrosis 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (49) (50) (49) Amyloid Deposition 1 (2%) 1 (2%) Congestion 2 (4%) Hemorrhage 1 (2%) Hyperplasia, Focal 1 (2%) Hypertrophy, Focal 1 (2%) Necrosis, Focal 2 (4%) 2 (4%) 1 (2%) Vacuolization Cytoplasmic, Focal 6 (12%) 8 (16%) 9 (18%) Adrenal Gland, Medulla (49) (50) (49) Hyperplasia 9 (18%) 5 (10%) 7 (14%) Infiltration Cellular, Lymphocyte 1 (2%) Islets, Pancreatic (49) (8) (50) Hyperplasia 2 (4%) Parathyroid Gland (47) (7) (48) Hyperplasia 1 (14%) Pituitary Gland (50) (37) (49) Hemorrhage 1 (2%) Pars Distalis, Angiectasis 15 (30%) 9 (24%) 15 (31%) Pars Distalis, Cyst 7 (14%) 2 (5%) 3 (6%) Pars Distalis, Cyst, Multiple 1 (2%) Pars Distalis, Hyperplasia 9 (18%) 6 (16%) 9 (18%) Pars Distalis, Infarct 1 (2%) Pars Distalis, Pigmentation 1 (3%) Pars Nervosa, Cyst 1 (2%) Pars Nervosa, Ectopic Tissue 1 (3%) 1 (2%) Thyroid Gland (49) (10) (49) Cyst 1 (2%) C-Cell, Hyperplasia 8 (16%) 5 (10%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (47) (13) (46) Dilatation 1 (2%) Hyperplasia 1 (2%) Inflammation, Acute 6 (13%) 1 (8%) 2 (4%) Ovary (50) (8) (50) Cyst 10 (20%) 3 (6%) Inflammation, Chronic 1 (2%) Mineralization 1 (13%) Uterus (50) (22) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Angiectasis 1 (2%) Fibrosis 1 (2%) Hemorrhage 1 (2%) Inflammation, Chronic 1 (2%) Cervix, Inflammation, Acute 1 (5%) Endometrium, Hyperplasia, Cystic 5 (10%) 3 (14%) 4 (8%) Vagina (1) Inflammation, Acute 1 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (8) (50) Fibrosis 1 (2%) 1 (2%) Hyperplasia 2 (25%) 1 (2%) Lymph Node (50) (27) (49) Axillary, Hemorrhage 1 (2%) Axillary, Hyperplasia, Lymphoid 2 (4%) Bronchial, Hemorrhage 1 (2%) Iliac, Cyst 1 (2%) 1 (4%) Iliac, Hemorrhage 1 (4%) Iliac, Hyperplasia, Lymphoid 2 (7%) Inguinal, Hyperplasia, Lymphoid 1 (4%) Lymphocyte, Mandibular, Necrosis 1 (2%) Mandibular, Cyst 4 (8%) 1 (2%) Mandibular, Hemorrhage 5 (10%) 4 (8%) Mediastinal, Hemorrhage 7 (14%) 7 (26%) 14 (29%) Mediastinal, Pigmentation 1 (2%) 1 (2%) Mediastinal, Lymphocyte, Necrosis 1 (2%) Prefemoral, Hyperplasia, Lymphoid 1 (4%) Lymph Node, Mesenteric (50) (8) (49) Hemorrhage 4 (8%) 1 (13%) 4 (8%) Hyperplasia, Lymphoid 1 (2%) Spleen (49) (22) (50) Congestion 1 (2%) Fibrosis, Focal 1 (2%) 1 (5%) 2 (4%) Hematopoietic Cell Proliferation 2 (4%) 3 (14%) 2 (4%) Hemorrhage 1 (5%) Inflammation, Focal, Granulomatous 1 (2%) Necrosis, Focal 1 (2%) 1 (5%) Pigmentation 2 (4%) 2 (9%) 1 (2%) Thymus (48) (8) (49) Cyst 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (47) (50) Dilatation 6 (12%) 4 (9%) 1 (2%) Hyperplasia 4 (8%) 1 (2%) 3 (6%) Skin (50) (8) (50) Cyst 1 (2%) Subcutaneous Tissue, Abscess 1 (2%) 1 (2%) Subcutaneous Tissue, Edema 1 (2%) Subcutaneous Tissue, Thrombosis, Multiple 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (49) (8) (50) Osteoporosis 1 (13%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (8) (50) Thrombosis 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (33) (38) Inflammation, Chronic 1 (3%) Lung (50) (29) (50) Foreign Body 1 (2%) Hemorrhage 12 (24%) 13 (45%) 4 (8%) Hyperplasia, Adenomatous 2 (4%) 3 (10%) 1 (2%) Infiltration Cellular, Histiocyte 7 (14%) 2 (7%) 1 (2%) Thrombosis 1 (2%) Interstitium, Inflammation, Chronic 3 (6%) 10 (20%) Nose (49) (8) (50) Metaplasia, Squamous 1 (13%) Nasolacrimal Duct, Fungus 1 (2%) Nasolacrimal Duct, Inflammation, Acute 1 (2%) 1 (13%) 1 (2%) Sinus, Foreign Body 1 (2%) Sinus, Fungus 1 (2%) 1 (13%) 1 (2%) Sinus, Inflammation, Acute 3 (6%) 2 (25%) 1 (2%) Turbinate, Inflammation, Chronic 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS FEMALE CONTROL 12500PPM 25000PPM FEMALE FEMALE FEMALE ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (3) (5) (2) Cornea, Inflammation, Chronic 1 (20%) Iris, Inflammation, Chronic 1 (33%) Lens Capsule, Cataract 1 (33%) 5 (100%) 2 (100%) Retina, Atrophy 1 (33%) 5 (100%) 2 (100%) Sclera, Metaplasia, Osseous 1 (33%) 1 (20%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) Cyst 1 (2%) Fibrosis, Focal 1 (2%) Inflammation, Acute 3 (6%) Nephropathy 46 (92%) 47 (94%) 47 (94%) Pigmentation 1 (2%) 3 (6%) 3 (6%) Artery, Inflammation, Chronic 1 (2%) Pelvis, Dilatation 1 (2%) Pelvis, Inflammation, Acute 1 (2%) 1 (2%) Pelvis, Inflammation, Subacute 1 (2%) Pelvis, Mineralization 8 (16%) 30 (60%) 37 (74%) Pelvis, Epithelium, Hyperplasia 1 (2%) Urinary Bladder (50) (9) (50) Hemorrhage 1 (11%) Inflammation, Acute 1 (2%) Inflammation, Chronic 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ 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, Cecum (47) (15) (48) Edema 1 (2%) Hemorrhage 1 (2%) 1 (7%) Parasite Metazoan 1 (2%) Intestine Large, Colon (47) (14) (49) Mineralization 1 (7%) Parasite Metazoan 4 (9%) Intestine Large, Rectum (47) (14) (48) Parasite Metazoan 2 (4%) Intestine Small, Duodenum (48) (12) (49) Inflammation, Acute 1 (8%) Intestine Small, Jejunum (47) (11) (48) Hyperplasia, Lymphoid 1 (2%) Liver (50) (49) (50) Angiectasis 11 (22%) 16 (33%) 17 (34%) Congestion 1 (2%) 4 (8%) 2 (4%) Cyst 1 (2%) Cytologic Alterations 5 (10%) 13 (27%) 1 (2%) Cytologic Alterations, Multiple 11 (22%) 5 (10%) 12 (24%) Fibrosis 1 (2%) Fibrosis, Focal 2 (4%) Hematopoietic Cell Proliferation 1 (2%) Hemorrhage 1 (2%) Hepatodiaphragmatic Nodule 8 (16%) 4 (8%) 7 (14%) Hyperplasia, Focal 10 (20%) 8 (16%) 8 (16%) Hyperplasia, Multifocal 1 (2%) 1 (2%) Hyperplasia, Nodular 3 (6%) Inflammation, Chronic 1 (2%) Necrosis, Focal 2 (4%) Thrombosis 1 (2%) Vacuolization Cytoplasmic, Diffuse 1 (2%) Bile Duct, Hyperplasia 38 (76%) 39 (80%) 44 (88%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Bile Duct, Hyperplasia, Cystic 1 (2%) Centrilobular, Degeneration 1 (2%) Centrilobular, Necrosis 1 (2%) 2 (4%) Centrilobular, Vacuolization Cytoplasmic 2 (4%) 3 (6%) 6 (12%) Periportal, Vacuolization Cytoplasmic 1 (2%) Mesentery (5) (2) (5) Inflammation, Acute 1 (20%) Inflammation, Chronic 1 (20%) Fat, Inflammation, Acute 2 (40%) Fat, Necrosis 1 (20%) 2 (100%) 1 (20%) Pancreas (49) (16) (49) Accessory Spleen 1 (6%) Acinus, Atrophy, Diffuse 2 (4%) Acinus, Atrophy, Focal 14 (29%) 1 (6%) 17 (35%) Acinus, Hyperplasia, Focal 1 (2%) Artery, Inflammation, Chronic 3 (6%) Salivary Glands (50) (14) (50) Inflammation, Chronic 1 (2%) Stomach, Forestomach (49) (21) (49) Edema 1 (2%) 1 (5%) 1 (2%) Erosion 1 (5%) Inflammation, Acute 1 (2%) 1 (5%) Inflammation, Chronic 1 (2%) Mineralization 1 (2%) 1 (5%) Ulcer 4 (19%) 1 (2%) Artery, Inflammation, Chronic 1 (2%) Epithelium, Hyperplasia 3 (14%) 1 (2%) Stomach, Glandular (48) (21) (50) Amyloid Deposition 1 (5%) Erosion 4 (8%) 5 (24%) 3 (6%) Inflammation, Acute 1 (2%) Mineralization 2 (4%) 1 (5%) Pigmentation 1 (2%) Ulcer 1 (2%) 1 (5%) 4 (8%) Tongue (3) Inflammation, Chronic 1 (33%) Epithelium, Hyperplasia 2 (67%) Tooth (1) Inflammation, Acute 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (2) (1) Aorta, Inflammation, Chronic 1 (50%) Aorta, Mineralization 1 (50%) 1 (100%) Heart (50) (20) (50) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Cardiomyopathy 38 (76%) 16 (80%) 40 (80%) Mineralization 1 (5%) Atrium, Thrombosis 6 (12%) 5 (25%) 4 (8%) Endocardium, Thrombosis 1 (5%) Epicardium, Fibrosis, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Gland, Cortex (50) (49) (50) Angiectasis 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Hyperplasia 1 (2%) 1 (2%) Inflammation, Subacute 1 (2%) Necrosis, Focal 1 (2%) Thrombosis 1 (2%) Vacuolization Cytoplasmic, Focal 2 (4%) 2 (4%) 1 (2%) Adrenal Gland, Medulla (48) (50) (50) Hyperplasia 17 (35%) 21 (42%) 13 (26%) Islets, Pancreatic (49) (16) (49) Hyperplasia 4 (8%) 1 (6%) 3 (6%) Parathyroid Gland (49) (15) (45) Hyperplasia 3 (6%) 1 (7%) 1 (2%) Pituitary Gland (50) (49) (50) Pars Distalis, Angiectasis 3 (6%) 3 (6%) 2 (4%) Pars Distalis, Cyst 1 (2%) 2 (4%) 7 (14%) Pars Distalis, Hyperplasia 3 (6%) 9 (18%) 8 (16%) Pars Nervosa, Ectopic Tissue 1 (2%) 1 (2%) Thyroid Gland (49) (18) (50) Cyst 2 (4%) C-Cell, Hyperplasia 5 (10%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Preputial Gland (50) (20) (49) Cyst 1 (2%) Hyperplasia 1 (2%) 2 (4%) Inflammation, Acute 11 (22%) 2 (10%) 8 (16%) Inflammation, Chronic 1 (2%) Prostate (50) (14) (49) Hyperplasia, Focal 6 (12%) 5 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Inflammation, Acute 17 (34%) 1 (7%) 8 (16%) Inflammation, Chronic 2 (4%) Seminal Vesicle (48) (37) (47) Atrophy 25 (52%) 15 (41%) 25 (53%) Inflammation, Acute 1 (2%) Testes (50) (50) (50) Atrophy 15 (30%) 14 (28%) 24 (48%) Interstitial Cell, Hyperplasia 2 (4%) 5 (10%) 2 (4%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (49) (14) (50) Fibrosis 1 (2%) Hyperplasia 2 (4%) 5 (36%) 2 (4%) Lymph Node (50) (33) (50) Axillary, Hyperplasia, Lymphoid 1 (3%) Iliac, Cyst 1 (3%) Inguinal, Cyst 1 (2%) 1 (2%) Inguinal, Hyperplasia, Lymphoid 2 (4%) 1 (3%) 2 (4%) Mandibular, Cyst 7 (14%) 3 (6%) Mandibular, Hemorrhage 1 (2%) Mandibular, Hyperplasia, Lymphoid 1 (3%) 2 (4%) Mediastinal, Cyst 1 (2%) Mediastinal, Hemorrhage 9 (18%) 8 (24%) 10 (20%) Mediastinal, Pigmentation 3 (6%) Pancreatic, Hemorrhage 1 (2%) Renal, Hemorrhage 1 (3%) Renal, Inflammation, Chronic 1 (2%) Lymph Node, Mesenteric (50) (18) (50) Cyst 1 (2%) 2 (11%) 1 (2%) Edema 1 (2%) 1 (2%) Hemorrhage 3 (6%) 4 (22%) 1 (2%) Spleen (49) (49) (50) Amyloid Deposition 1 (2%) Congestion 3 (6%) 1 (2%) 2 (4%) Depletion Lymphoid 1 (2%) Fibrosis, Focal 8 (16%) 5 (10%) 7 (14%) Hematopoietic Cell Proliferation 2 (4%) 5 (10%) 5 (10%) Hyperplasia, Lymphoid 1 (2%) Infarct 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) 1 (2%) Inflammation, Focal, Granulomatous 1 (2%) Necrosis 2 (4%) 1 (2%) Pigmentation 1 (2%) Capsule, Fibrosis, Focal 1 (2%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (48) (18) (50) Dilatation 1 (2%) 2 (11%) 2 (4%) Hyperplasia 1 (2%) Skin (49) (21) (50) Cyst 1 (5%) Edema 1 (2%) 1 (5%) Hyperkeratosis 1 (2%) Inflammation, Acute 2 (4%) Inflammation, Chronic 1 (5%) Epithelium, Lip, Hyperplasia 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (14) (50) Hyperostosis 1 (2%) Osteomalacia 1 (2%) 1 (7%) Tarsal, Inflammation, Chronic Active 1 (2%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (13) (50) Hemorrhage 1 (2%) 1 (2%) Thrombosis 2 (4%) 6 (12%) Thrombosis, Multiple 1 (2%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Larynx (26) (27) Inflammation, Subacute 1 (4%) Ulcer 1 (4%) Lung (50) (30) (50) Congestion 1 (2%) 1 (3%) Fibrosis 1 (2%) Foreign Body 1 (2%) Hemorrhage 2 (4%) 1 (3%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Hyperplasia, Adenomatous 4 (8%) 4 (13%) 2 (4%) Infiltration Cellular, Histiocyte 4 (8%) 1 (3%) 1 (2%) Pigmentation 1 (2%) Interstitium, Inflammation, Chronic 1 (2%) 2 (7%) 5 (10%) Nose (49) (14) (50) Inflammation, Acute 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 05706-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC 4,4-DIAMINO-2,2-STILBENEDISULFONIC ACID Date: 09/18/94 Route: DOSED FEED Time: 23:48:55 ____________________________________________________________________________________________________________________________________ FISCHER 344 RATS MALE CONTROL 12500PPM 25000PPM MALE MALE MALE ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM - CONT Nasolacrimal Duct, Inflammation, Acute 1 (2%) 2 (4%) Sinus, Foreign Body 1 (7%) 2 (4%) Sinus, Fungus 4 (8%) 2 (14%) 3 (6%) Sinus, Inflammation, Acute 8 (16%) 4 (29%) 9 (18%) Turbinate, Inflammation, Chronic 5 (10%) Turbinate, Inflammation, Subacute 1 (2%) Turbinate, Thrombosis 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (2) Lens Capsule, Cataract 2 (100%) Retina, Atrophy 2 (100%) Sclera, Metaplasia, Osseous 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (45) (50) Cyst 3 (6%) 2 (4%) 3 (6%) Developmental Malformation 1 (2%) Fibrosis, Focal 1 (2%) 1 (2%) Hematopoietic Cell Proliferation 1 (2%) Nephropathy 48 (96%) 42 (93%) 46 (92%) Pigmentation 1 (2%) Pelvis, Dilatation 1 (2%) Pelvis, Mineralization 1 (2%) 3 (6%) Renal Tubule, Degeneration 1 (2%) 1 (2%) Urinary Bladder (50) (14) (49) Hemorrhage 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 13 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------