TDMS Study 05150-02 Pathology Tables
INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) METHYLPHENIDATE HYDROCHLORIDE NTP Experiment-Test: 05150-02 Report: PEIRPT03 Study Type: CHRONIC Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 Facility: TSI Mason Research Chemical CAS #: 298-59-9 Lock Date: 02/19/92 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: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 69 69 70 70 Scheduled Sacrifice 20 19 20 20 Early Deaths Natural Death 5 7 6 Accidently Killed 1 Moribund Sacrifice 6 7 7 6 Survivors Terminal Sacrifice 36 34 37 44 Natural Death 1 1 Missing 1 Animals Examined Microscopically 69 68 70 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (64) (56) (63) (68) Dilatation 1 (2%) 1 (1%) Intestine Large, Cecum (67) (63) (65) (70) Edema 1 (2%) Hyperplasia, Lymphoid 30 (45%) 18 (29%) 18 (28%) 17 (24%) Intestine Small, Jejunum (65) (63) (65) (70) Hyperplasia, Lymphoid 1 (2%) 1 (1%) Liver (69) (67) (69) (70) Angiectasis 1 (1%) 1 (1%) 1 (1%) Autolysis 1 (1%) Basophilic Focus 2 (3%) 4 (6%) 3 (4%) 1 (1%) Clear Cell Focus 2 (3%) 2 (3%) Congestion 1 (1%) Eosinophilic Focus 3 (4%) 3 (4%) 10 (14%) 27 (39%) Fatty Change 1 (1%) 1 (1%) 8 (12%) 5 (7%) Fatty Change, Focal 2 (3%) Hematopoietic Cell Proliferation 1 (1%) 1 (1%) 2 (3%) Hemorrhage 1 (1%) Hyperplasia, Lymphoid 2 (3%) 1 (1%) Necrosis, Focal 7 (10%) 4 (6%) 7 (10%) 13 (19%) Mesentery (6) (1) (2) Fat, Necrosis 5 (83%) 2 (100%) Pancreas (68) (67) (69) (70) Inflammation, Chronic, Focal 2 (3%) 2 (3%) 1 (1%) 1 (1%) Acinus, Atrophy 1 (1%) 1 (1%) 2 (3%) Duct, Ectasia 2 (3%) 1 (1%) 2 (3%) Salivary Glands (69) (67) (70) (69) Inflammation, Chronic, Focal 6 (9%) 7 (10%) 7 (10%) 9 (13%) Stomach, Forestomach (67) (68) (69) (70) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Abscess 1 (1%) Diverticulum 1 (1%) 1 (1%) Ulcer 1 (1%) 1 (1%) Stomach, Glandular (68) (65) (68) (70) Edema 1 (2%) Erosion 2 (3%) Inflammation, Chronic 1 (2%) 1 (1%) Inflammation, Chronic, Focal 1 (1%) Inflammation, Subacute 1 (1%) Muscularis, Hypertrophy 1 (1%) 1 (1%) Tongue (3) (1) Angiectasis 3 (100%) 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (68) (68) (69) (70) Artery, Inflammation, Chronic 1 (1%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (69) (67) (68) (70) Congestion 1 (1%) Cytoplasmic Alteration, Focal 2 (3%) Fibrosis 1 (1%) Hematopoietic Cell Proliferation 1 (1%) 1 (1%) Hyperplasia, Focal 1 (1%) 1 (1%) Hypertrophy 1 (1%) 2 (3%) Capsule, Hyperplasia 1 (1%) Adrenal Medulla (67) (64) (66) (68) Hyperplasia, Focal 1 (1%) 1 (2%) Islets, Pancreatic (68) (67) (69) (70) Hyperplasia 7 (10%) 9 (13%) 10 (14%) 11 (16%) Hypoplasia 1 (1%) Pituitary Gland (67) (66) (68) (67) Pars Distalis, Angiectasis 1 (1%) 1 (2%) 1 (1%) Pars Distalis, Hyperplasia, Focal 14 (21%) 10 (15%) 13 (19%) 11 (16%) Thyroid Gland (69) (66) (68) (69) Inflammation, Acute, Focal 1 (1%) Inflammation, Chronic 1 (2%) Follicle, Cyst 2 (3%) 1 (1%) Follicular Cell, Hyperplasia, Focal 4 (6%) 11 (17%) 8 (12%) 5 (7%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (43) (41) (44) (46) Abscess 1 (2%) Angiectasis 1 (2%) Cyst 1 (2%) Dilatation 2 (5%) 1 (2%) Pigmentation, Hemosiderin 1 (2%) Ovary (65) (67) (69) (67) Abscess 1 (1%) Angiectasis 1 (1%) Cyst 7 (11%) 13 (19%) 13 (19%) 9 (13%) Mineralization, Focal 1 (1%) 1 (1%) Thrombosis 1 (1%) Uterus (69) (68) (69) (70) Angiectasis 1 (1%) 3 (4%) 2 (3%) 2 (3%) Fibrosis, Focal 1 (1%) Hydrometra 6 (9%) 8 (12%) 6 (9%) 14 (20%) Inflammation, Suppurative 1 (1%) 2 (3%) Thrombosis 1 (1%) Endometrium, Hyperplasia, Cystic 63 (91%) 62 (91%) 58 (84%) 61 (87%) Endometrium, Metaplasia, Squamous 1 (1%) 2 (3%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (69) (68) (67) (70) Angiectasis 1 (1%) Hyperplasia, Neutrophil 2 (3%) 6 (9%) 5 (7%) 2 (3%) Myelofibrosis 25 (36%) 21 (31%) 22 (33%) 21 (30%) Lymph Node (7) (7) (8) (5) Lumbar, Hematopoietic Cell Proliferation 1 (14%) Lumbar, Lymphatic, Angiectasis 1 (13%) Mediastinal, Hyperplasia, Lymphoid 1 (14%) Mediastinal, Infiltration Cellular, Mixed Cell 1 (13%) Pancreatic, Hyperplasia, Lymphoid 1 (14%) 2 (25%) Renal, Hematopoietic Cell Proliferation 1 (14%) Lymph Node, Mandibular (67) (61) (68) (68) Congestion 1 (2%) Hematopoietic Cell Proliferation 1 (1%) Necrosis 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Lymphatic, Angiectasis 1 (1%) Lymph Node, Mesenteric (65) (66) (67) (67) Congestion 1 (2%) Depletion Lymphoid 1 (2%) Inflammation, Chronic 1 (2%) Lymphatic, Angiectasis 1 (2%) 3 (4%) 1 (1%) Spleen (68) (67) (68) (70) Congestion 1 (1%) 1 (1%) 2 (3%) Depletion Lymphoid 1 (1%) 3 (4%) 3 (4%) 1 (1%) Hematopoietic Cell Proliferation 8 (12%) 10 (15%) 13 (19%) 9 (13%) Hyperplasia, Lymphoid 2 (3%) 1 (1%) 4 (6%) 2 (3%) Necrosis, Focal 1 (1%) 1 (1%) Thymus (65) (66) (67) (69) Angiectasis 1 (1%) Depletion Lymphoid 1 (2%) 2 (3%) 2 (3%) Hyperplasia, Lymphoid 2 (3%) 1 (1%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (59) (60) (63) (64) Lactation 1 (2%) 2 (3%) 3 (5%) 2 (3%) Skin (69) (68) (70) (70) Inflammation, Chronic 1 (1%) Ulcer 1 (1%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (69) (68) (70) (70) Hyperostosis 1 (1%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (69) (68) (70) (70) Compression 1 (1%) 1 (1%) Hemorrhage, Focal 1 (1%) Mineralization 42 (61%) 38 (56%) 36 (51%) 38 (54%) Mineralization, Focal 2 (3%) 1 (1%) 1 (1%) Artery, Inflammation, Chronic 1 (1%) Spinal Cord (1) Artery, Inflammation, Chronic 1 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (68) (68) (69) (70) Congestion 1 (1%) 1 (1%) Hemorrhage, Focal 2 (3%) 2 (3%) 1 (1%) Inflammation, Chronic 1 (1%) 1 (1%) Thrombosis 1 (1%) Alveolar Epithelium, Hyperplasia 4 (6%) Peribronchial, Inflammation, Chronic 3 (4%) 1 (1%) 5 (7%) Nose (69) (68) (70) (70) Degeneration, Hyaline 8 (12%) 4 (6%) 7 (10%) 8 (11%) Inflammation, Chronic 54 (78%) 49 (72%) 51 (73%) 56 (80%) Inflammation, Chronic, Focal 10 (14%) 8 (12%) 10 (14%) 10 (14%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (2) (1) (4) (5) Hyperplasia 1 (50%) 1 (25%) 1 (20%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (69) (67) (70) (70) Congestion 1 (1%) 1 (1%) Fatty Change 2 (3%) Glomerulosclerosis 2 (3%) 2 (3%) 1 (1%) Hemorrhage, Focal 1 (1%) Hyperplasia, Lymphoid 1 (1%) 1 (1%) 1 (1%) Infarct 2 (3%) 2 (3%) 3 (4%) Inflammation, Chronic, Focal 1 (1%) Mineralization 1 (1%) 1 (1%) Nephropathy 1 (1%) 1 (1%) Renal Tubule, Degeneration, Granular 1 (1%) 2 (3%) Renal Tubule, Necrosis 2 (3%) Renal Tubule, Regeneration 7 (10%) 3 (4%) 3 (4%) 3 (4%) Urinary Bladder (63) (59) (64) (70) Inflammation, Chronic, Focal 8 (13%) 7 (12%) 9 (14%) 9 (13%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 70 70 70 70 Scheduled Sacrifice 20 20 20 20 Early Deaths Moribund Sacrifice 2 2 4 4 Natural Death 3 3 2 5 Survivors Terminal Sacrifice 45 45 43 41 Moribund Sacrifice 1 Animals Examined Microscopically 70 70 70 70 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Gallbladder (64) (67) (64) (62) Ulcer 1 (2%) Intestine Large, Cecum (68) (69) (68) (67) Hyperplasia, Lymphoid 33 (49%) 18 (26%) 23 (34%) 24 (36%) Intestine Small, Jejunum (68) (68) (67) (66) Hyperplasia, Lymphoid 3 (4%) 1 (1%) 2 (3%) 1 (2%) Inflammation, Acute 1 (1%) 1 (2%) Ulcer 1 (1%) Intestine Small, Ileum (66) (68) (67) (65) Hyperplasia, Lymphoid 1 (2%) Liver (70) (70) (70) (70) Angiectasis 4 (6%) 2 (3%) 1 (1%) Basophilic Focus 1 (1%) 2 (3%) 5 (7%) 1 (1%) Clear Cell Focus 5 (7%) 3 (4%) 3 (4%) 6 (9%) Eosinophilic Focus 6 (9%) 9 (13%) 9 (13%) 14 (20%) Fatty Change 12 (17%) 13 (19%) 13 (19%) 24 (34%) Fatty Change, Focal 2 (3%) 2 (3%) Inflammation, Chronic, Focal 1 (1%) 1 (1%) 1 (1%) Necrosis, Focal 3 (4%) 1 (1%) 4 (6%) 6 (9%) Thrombosis 1 (1%) 1 (1%) 1 (1%) Artery, Inflammation, Acute 1 (1%) Mesentery (2) (3) (1) (2) Cyst 1 (100%) Hemorrhage, Focal 1 (50%) Mineralization 1 (50%) Fat, Necrosis 1 (50%) 2 (67%) 1 (50%) Pancreas (70) (69) (69) (70) Hyperplasia, Focal 2 (3%) Inflammation, Chronic, Focal 1 (1%) Salivary Glands (70) (70) (70) (70) Inflammation, Chronic, Focal 2 (3%) 7 (10%) 4 (6%) 8 (11%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Stomach, Forestomach (69) (70) (70) (70) Foreign Body 1 (1%) Hyperkeratosis, Focal 1 (1%) Ulcer 2 (3%) Stomach, Glandular (68) (69) (70) (67) Erosion 1 (1%) 2 (3%) 2 (3%) Hyperplasia 1 (1%) Inflammation, Acute 1 (1%) Inflammation, Chronic 2 (3%) 1 (1%) 1 (1%) 3 (4%) Mucosa, Hyperplasia, Focal 1 (1%) Perivascular, Inflammation, Chronic 1 (1%) Tongue (3) (1) (2) Hemorrhage, Focal 1 (33%) 1 (50%) Hyperkeratosis, Focal 1 (100%) Pigmentation, Focal 1 (33%) 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Heart (70) (70) (70) (70) Inflammation, Chronic, Focal 1 (1%) Mineralization 1 (1%) Ventricle, Hypertrophy 1 (1%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (69) (69) (70) (70) Atrophy 2 (3%) Fibrosis 1 (1%) Hyperplasia, Focal 14 (20%) 18 (26%) 15 (21%) 13 (19%) Capsule, Hyperplasia 1 (1%) 1 (1%) 1 (1%) Capsule, Hyperplasia, Focal 1 (1%) Adrenal Medulla (68) (67) (69) (66) Hyperplasia 1 (1%) Hyperplasia, Focal 2 (3%) Islets, Pancreatic (70) (68) (69) (70) Atrophy 1 (1%) Hyperplasia 24 (34%) 27 (40%) 22 (32%) 20 (29%) Pituitary Gland (68) (68) (64) (64) Pars Distalis, Cyst 1 (1%) Thyroid Gland (70) (69) (69) (70) Follicle, Cyst 1 (1%) Follicular Cell, Hyperplasia 2 (3%) 1 (1%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (70) (70) (70) (70) Atrophy 1 (1%) 1 (1%) Inflammation, Chronic 1 (1%) Spermatocele 1 (1%) 1 (1%) Preputial Gland (54) (53) (55) (54) Abscess 1 (2%) 1 (2%) Atrophy 1 (2%) Cyst 36 (67%) 42 (79%) 42 (76%) 35 (65%) Depletion Cellular 1 (2%) Dilatation 28 (52%) 25 (47%) 25 (45%) 28 (52%) Hemorrhage, Focal 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) Inflammation, Acute 6 (11%) 8 (15%) 7 (13%) 4 (7%) Inflammation, Chronic 9 (17%) 8 (15%) 9 (16%) 6 (11%) Prostate (69) (69) (67) (65) Atrophy 2 (3%) 1 (2%) Inflammation, Acute 1 (2%) Inflammation, Chronic 1 (1%) 2 (3%) 2 (3%) Inflammation, Chronic, Focal 2 (3%) Seminal Vesicle (70) (69) (70) (70) Depletion Cellular 4 (6%) 2 (3%) 3 (4%) 2 (3%) Dilatation 5 (7%) 5 (7%) 7 (10%) 3 (4%) Fibrosis 1 (1%) Testes (70) (70) (70) (70) Hypospermia 1 (1%) 1 (1%) 1 (1%) 2 (3%) Interstitial Cell, Hyperplasia 1 (1%) Seminiferous Tubule, Atrophy 1 (1%) 2 (3%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (70) (70) (70) (69) Hyperplasia, Neutrophil 2 (3%) 1 (1%) 3 (4%) Myelofibrosis 1 (1%) 1 (1%) 1 (1%) Lymph Node (3) (5) (1) (2) Mediastinal, Infiltration Cellular, Plasma Cell 1 (20%) Pancreatic, Hyperplasia 2 (67%) Renal, Lymphatic, Angiectasis 1 (50%) Lymph Node, Mandibular (66) (65) (67) (66) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Infiltration Cellular, Plasma Cell 1 (2%) Lymph Node, Mesenteric (68) (65) (65) (65) Congestion 2 (3%) 3 (5%) 3 (5%) 2 (3%) Fibrosis 1 (2%) Hyperplasia 1 (1%) 1 (2%) Hyperplasia, Lymphoid 1 (2%) Infiltration Cellular, Plasma Cell 1 (2%) Thrombosis 1 (1%) Spleen (69) (69) (69) (70) Congestion 1 (1%) 1 (1%) 1 (1%) Cyst 1 (1%) Depletion Lymphoid 5 (7%) 3 (4%) 4 (6%) 1 (1%) Fibrosis, Focal 2 (3%) Hematopoietic Cell Proliferation 6 (9%) 7 (10%) 9 (13%) 8 (11%) Hyperplasia, Lymphoid 1 (1%) 1 (1%) Infiltration Cellular, Plasma Cell 1 (1%) Thymus (58) (60) (58) (56) Cyst 1 (2%) Hyperplasia, Lymphoid 1 (2%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (70) (70) (69) (70) Inflammation, Chronic 1 (1%) Ulcer 1 (1%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (70) (70) (70) (70) Hyperostosis 1 (1%) 1 (1%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (70) (70) (70) (70) Compression 1 (1%) Hemorrhage, Focal 1 (1%) Mineralization 36 (51%) 42 (60%) 34 (49%) 34 (49%) Mineralization, Focal 5 (7%) 3 (4%) 4 (6%) 5 (7%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (70) (69) (70) (70) Angiectasis 1 (1%) Congestion 1 (1%) 1 (1%) Hemorrhage, Focal 5 (7%) 1 (1%) 1 (1%) Infiltration Cellular, Histiocyte 1 (1%) Inflammation, Chronic 1 (1%) 1 (1%) Alveolar Epithelium, Hyperplasia 3 (4%) 1 (1%) 4 (6%) 3 (4%) Peribronchial, Inflammation, Chronic 4 (6%) 4 (6%) 7 (10%) 3 (4%) Nose (70) (70) (70) (70) Degeneration, Hyaline 3 (4%) 2 (3%) Inflammation, Chronic 55 (79%) 53 (76%) 52 (74%) 52 (74%) Inflammation, Chronic, Focal 11 (16%) 8 (11%) 10 (14%) 10 (14%) Metaplasia, Squamous 1 (1%) 1 (1%) 1 (1%) Olfactory Epithelium, Hyperplasia 1 (1%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (5) (2) (2) Hyperplasia 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (70) (70) (70) (70) Casts 1 (1%) Cyst 1 (1%) 1 (1%) 1 (1%) 3 (4%) Glomerulosclerosis 1 (1%) 1 (1%) 1 (1%) 1 (1%) Hemorrhage 1 (1%) Hyperplasia, Lymphoid 2 (3%) 1 (1%) Infarct 1 (1%) 2 (3%) 1 (1%) 1 (1%) Inflammation, Chronic, Focal 2 (3%) 1 (1%) Metaplasia, Osseous 1 (1%) Mineralization 16 (23%) 14 (20%) 13 (19%) 18 (26%) Nephropathy 1 (1%) 2 (3%) 1 (1%) Renal Tubule, Degeneration, Granular 1 (1%) 2 (3%) Renal Tubule, Regeneration 38 (54%) 37 (53%) 40 (57%) 36 (51%) Urinary Bladder (68) (68) (68) (67) Calculus Micro Observation Only 1 (1%) 1 (1%) Concretion 1 (1%) 1 (1%) Ectasia 1 (1%) Inflammation, Chronic, Focal 1 (1%) 6 (9%) 2 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95 Route: DOSED FEED Time: 09:59:03 ____________________________________________________________________________________________________________________________________ B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Perivascular, Inflammation, Chronic 1 (1%) 1 (1%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 ------------------------------------------------------------ ---------- END OF REPORT ---------- 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