TDMS Study 05150-02 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
METHYLPHENIDATE HYDROCHLORIDE
NTP Experiment-Test: 05150-02 Report: PEIRPT05
Study Type: CHRONIC Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
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 NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
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)
Intestine Large, Rectum (65) (65) (67) (70)
Intestine Large, Cecum (67) (63) (65) (70)
Intestine Small, Duodenum (65) (62) (65) (70)
Polyp Adenomatous 1 (2%)
Intestine Small, Jejunum (65) (63) (65) (70)
Adenocarcinoma 1 (2%)
Hemangioma 1 (2%)
Intestine Small, Ileum (65) (61) (65) (69)
Liver (69) (67) (69) (70)
Hemangioma 1 (1%)
Hemangiosarcoma 1 (1%) 1 (1%) 1 (1%)
Hepatocellular Carcinoma 3 (4%) 3 (4%) 2 (3%) 5 (7%)
Hepatocellular Carcinoma, Multiple 2 (3%) 1 (1%)
Hepatocellular Adenoma 5 (7%) 11 (16%) 8 (12%) 14 (20%)
Hepatocellular Adenoma, Multiple 2 (3%) 3 (4%) 15 (21%)
Histiocytic Sarcoma 1 (1%) 1 (1%)
Histiocytic Sarcoma, Metastatic, Uterus 1 (1%)
Mesentery (6) (1) (2)
Sarcoma 1 (17%)
Pancreas (68) (67) (69) (70)
Salivary Glands (69) (67) (70) (69)
Stomach, Forestomach (67) (68) (69) (70)
Squamous Cell Papilloma 1 (1%) 1 (1%) 1 (1%)
Stomach, Glandular (68) (65) (68) (70)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (68) (68) (69) (70)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (69) (67) (68) (70)
Adenocarcinoma, Metastatic, Uterus 1 (1%)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (1%)
Capsule, Adenoma 1 (1%)
Adrenal Medulla (67) (64) (66) (68)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (1%)
Islets, Pancreatic (68) (67) (69) (70)
Adenoma 1 (1%) 2 (3%) 2 (3%) 1 (1%)
Pituitary Gland (67) (66) (68) (67)
Pars Distalis, Adenoma 7 (10%) 10 (15%) 15 (22%) 9 (13%)
Pars Intermedia, Adenoma 1 (1%) 1 (1%)
Thyroid Gland (69) (66) (68) (69)
Follicular Cell, Adenoma 6 (9%) 4 (6%)
Follicular Cell, Carcinoma 1 (1%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (2)
Hemangiosarcoma 1 (50%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (65) (67) (69) (67)
Cystadenoma 2 (3%) 4 (6%) 1 (1%) 2 (3%)
Cystadenoma, Multiple 1 (1%)
Histiocytic Sarcoma, Metastatic, Uterus 1 (1%)
Teratoma NOS 1 (2%) 1 (1%)
Uterus (69) (68) (69) (70)
Hemangioma 1 (1%) 1 (1%)
Histiocytic Sarcoma 2 (3%) 1 (1%) 1 (1%)
Leiomyoma 1 (1%)
Polyp Stromal 2 (3%) 6 (9%) 1 (1%)
Endometrium, Adenocarcinoma 1 (1%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (69) (68) (67) (70)
Adenocarcinoma, Metastatic, Uterus 1 (1%)
Hemangiosarcoma 1 (1%)
Histiocytic Sarcoma 1 (1%)
Lymph Node (7) (7) (8) (5)
Lumbar, Histiocytic Sarcoma, Metastatic,
Uterus 1 (13%)
Lumbar, Sarcoma, Metastatic, Skin 1 (13%)
Lymph Node, Mandibular (67) (61) (68) (68)
Carcinoma, Metastatic, Harderian Gland 1 (1%)
Histiocytic Sarcoma 1 (1%)
Histiocytic Sarcoma, Metastatic, Uterus 1 (1%)
Lymph Node, Mesenteric (65) (66) (67) (67)
Histiocytic Sarcoma 1 (1%)
Histiocytic Sarcoma, Metastatic, Uterus 1 (1%)
Spleen (68) (67) (68) (70)
Hemangioma 1 (1%)
Hemangiosarcoma 2 (3%) 1 (1%)
Histiocytic Sarcoma 1 (1%) 1 (1%)
Thymus (65) (66) (67) (69)
Adenocarcinoma, Metastatic, Uterus 1 (1%)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (1%)
Histiocytic Sarcoma 1 (1%)
Histiocytic Sarcoma, Metastatic, Uterus 1 (1%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (59) (60) (63) (64)
Adenocarcinoma 1 (2%)
Adenocarcinoma, Metastatic, Uterus 1 (2%)
Adenoma 1 (2%)
Skin (69) (68) (70) (70)
Hemangiosarcoma 1 (1%)
Histiocytic Sarcoma 1 (1%)
Sarcoma 1 (1%) 1 (1%) 1 (1%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (69) (68) (70) (70)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (1%)
Skeletal Muscle (1)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (69) (68) (70) (70)
Adenocarcinoma, Metastatic, Uterus 1 (1%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (68) (68) (69) (70)
Adenocarcinoma, Metastatic, Uterus 1 (1%)
Alveolar/Bronchiolar Adenoma 2 (3%) 1 (1%) 4 (6%) 6 (9%)
Alveolar/Bronchiolar Carcinoma 2 (3%) 2 (3%)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (1%)
Carcinoma, Metastatic, Harderian Gland 1 (1%)
Carcinoma, Metastatic, Thyroid Gland 1 (1%)
Hepatocellular Carcinoma, Metastatic, Liver 2 (3%) 1 (1%)
Histiocytic Sarcoma, Metastatic, Uterus 1 (1%)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (1%)
Sarcoma, Metastatic, Skin 1 (1%)
Nose (69) (68) (70) (70)
Carcinoma, Metastatic, Harderian Gland 1 (1%)
Histiocytic Sarcoma, Metastatic, Uterus 1 (1%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (1) (4) (5)
Adenoma 1 (50%) 3 (75%) 1 (20%)
Carcinoma 1 (100%) 3 (60%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (69) (67) (70) (70)
Adenocarcinoma, Metastatic, Uterus 1 (1%)
Urinary Bladder (63) (59) (64) (70)
Hemangioma 1 (1%)
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SYSTEMIC LESIONS
Multiple Organs *(69) *(68) *(70) *(70)
Histiocytic Sarcoma 2 (3%) 1 (1%) 2 (3%) 2 (3%)
Lymphoma Malignant Lymphocytic 1 (1%) 1 (1%) 2 (3%) 3 (4%)
Lymphoma Malignant Mixed 11 (16%) 12 (18%) 6 (9%) 14 (20%)
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS - cont
Multiple Organs *(69) *(68) *(70) *(70)
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Page 6
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 37 36 41 44
Total Primary Neoplasms 53 58 69 89
Total Animals with Benign Neoplasms 22 26 31 38
Total Benign Neoplasms 28 36 47 57
Total Animals with Malignant Neoplasms 22 20 16 26
Total Malignant Neoplasms 24 21 22 32
Total Animals with Metastatic Neoplasms 2 1 4 3
Total Metastatic Neoplasm 2 1 15 11
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1 1
Total Uncertain Neoplasms 1 1
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a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 7
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
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
Intestine Large, Cecum (68) (69) (68) (67)
Intestine Small, Duodenum (67) (68) (68) (68)
Intestine Small, Jejunum (68) (68) (67) (66)
Intestine Small, Ileum (66) (68) (67) (65)
Sarcoma 1 (1%)
Liver (70) (70) (70) (70)
Hemangioma 1 (1%)
Hemangiosarcoma 3 (4%) 2 (3%) 1 (1%)
Hepatoblastoma 1 (1%) 4 (6%)
Hepatoblastoma, Multiple 1 (1%) 1 (1%)
Hepatocellular Carcinoma 8 (11%) 8 (11%) 15 (21%) 11 (16%)
Hepatocellular Carcinoma, Multiple 2 (3%) 1 (1%) 2 (3%) 1 (1%)
Hepatocellular Adenoma 15 (21%) 8 (11%) 12 (17%) 16 (23%)
Hepatocellular Adenoma, Multiple 5 (7%) 10 (14%) 6 (9%) 15 (21%)
Histiocytic Sarcoma 1 (1%) 1 (1%)
Sarcoma 1 (1%)
Mesentery (2) (3) (1) (2)
Hepatoblastoma, Metastatic, Liver 1 (50%)
Sarcoma 1 (33%)
Pancreas (70) (69) (69) (70)
Hemangiosarcoma, Metastatic, Spleen 1 (1%)
Sarcoma 1 (1%)
Salivary Glands (70) (70) (70) (70)
Stomach, Forestomach (69) (70) (70) (70)
Squamous Cell Papilloma 1 (1%) 1 (1%)
Stomach, Glandular (68) (69) (70) (67)
Sarcoma 1 (1%)
Tongue (3) (1) (2)
Squamous Cell Papilloma 1 (33%)
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Page 8
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (70) (70) (70) (70)
Adenocarcinoma, Metastatic, Prostate 1 (1%)
Hemangiosarcoma 1 (1%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (69) (69) (70) (70)
Adenoma 1 (1%) 1 (1%)
Capsule, Adenoma 1 (1%) 2 (3%)
Adrenal Medulla (68) (67) (69) (66)
Pheochromocytoma Benign 1 (1%)
Islets, Pancreatic (70) (68) (69) (70)
Adenoma 1 (1%) 1 (1%) 1 (1%) 1 (1%)
Pituitary Gland (68) (68) (64) (64)
Pars Intermedia, Adenoma 1 (2%)
Pars Intermedia, Carcinoma 1 (2%)
Thyroid Gland (70) (69) (69) (70)
Follicular Cell, Adenoma 1 (1%) 1 (1%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Epididymis (70) (70) (70) (70)
Prostate (69) (69) (67) (65)
Adenocarcinoma 1 (1%)
Sarcoma 1 (1%)
Seminal Vesicle (70) (69) (70) (70)
Sarcoma 2 (3%)
Testes (70) (70) (70) (70)
Interstitial Cell, Adenoma 2 (3%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (70) (70) (70) (69)
Hemangiosarcoma 1 (1%) 1 (1%) 2 (3%)
Histiocytic Sarcoma 1 (1%)
Mast Cell Tumor NOS 1 (1%)
Lymph Node (3) (5) (1) (2)
Page 9
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Mediastinal, Histiocytic Sarcoma 1 (20%)
Mediastinal, Sarcoma 2 (40%)
Pancreatic, Sarcoma 1 (20%)
Lymph Node, Mandibular (66) (65) (67) (66)
Lymph Node, Mesenteric (68) (65) (65) (65)
Histiocytic Sarcoma 1 (2%)
Sarcoma 2 (3%)
Spleen (69) (69) (69) (70)
Hemangiosarcoma 1 (1%) 1 (1%) 3 (4%)
Histiocytic Sarcoma 1 (1%)
Mast Cell Tumor NOS 1 (1%)
Sarcoma 1 (1%)
Thymus (58) (60) (58) (56)
Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (70) (70) (69) (70)
Fibroma 1 (1%)
Hemangiosarcoma 1 (1%)
Lipoma 1 (1%)
Sarcoma 2 (3%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (70) (70) (70) (70)
Carcinoma, Metastatic, Pituitary Gland 1 (1%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (70) (69) (70) (70)
Adenocarcinoma, Metastatic, Prostate 1 (1%)
Alveolar/Bronchiolar Adenoma 13 (19%) 7 (10%) 5 (7%) 5 (7%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (1%) 2 (3%)
Alveolar/Bronchiolar Carcinoma 4 (6%) 5 (7%) 2 (3%) 1 (1%)
Carcinoma, Metastatic, Harderian Gland 1 (1%) 1 (1%)
Hepatoblastoma, Metastatic, Liver 1 (1%)
Hepatocellular Carcinoma, Metastatic, Liver 4 (6%) 4 (6%)
Histiocytic Sarcoma 1 (1%) 1 (1%)
Page 10
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Sarcoma 1 (1%)
Sarcoma, Metastatic, Mesentery 1 (1%)
Nose (70) (70) (70) (70)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (5) (2) (2)
Adenoma 4 (80%) 1 (50%) 1 (50%)
Carcinoma 1 (20%) 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (70) (70) (70) (70)
Histiocytic Sarcoma 1 (1%)
Urinary Bladder (68) (68) (68) (67)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(70) *(70) *(70) *(70)
Histiocytic Sarcoma 1 (1%) 1 (1%)
Lymphoma Malignant Lymphocytic 1 (1%) 1 (1%)
Lymphoma Malignant Mixed 3 (4%) 4 (6%) 3 (4%) 8 (11%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 05150-02 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHYLPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:59:05
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 0 PPM 50 PPM 250 PPM 500 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 43 36 35 46
Total Primary Neoplasms 69 73 58 77
Total Animals with Benign Neoplasms 33 24 25 35
Total Benign Neoplasms 45 31 31 40
Total Animals with Malignant Neoplasms 19 24 22 25
Total Malignant Neoplasms 24 42 27 35
Total Animals with Metastatic Neoplasms 5 2 5 4
Total Metastatic Neoplasm 5 3 5 4
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 2
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
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