TDMS Study 05150-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
METHLYPHENIDATE HYDROCHLORIDE
NTP Experiment-Test: 05150-01 Report: PEIRPT05
Study Type: CHRONIC Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
Facility: TSI Mason Research
Chemical CAS #: 298-59-9
Lock Date: 02/06/92
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: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 70 70 70 70
Scheduled Sacrifice 20 20 20 20
Early Deaths
Moribund Sacrifice 13 12 10 7
Natural Death 6 6 4 4
Survivors
Terminal Sacrifice 29 30 36 38
Moribund Sacrifice 1 1
Natural Death 2
Dead 1
Animals Examined Microscopically 70 70 70 70
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (67) (67) (69) (69)
Fibroma 1 (1%)
Intestine Small, Duodenum (67) (66) (70) (69)
Sarcoma Stromal, Metastatic, Uterus 1 (1%)
Intestine Small, Jejunum (67) (63) (68) (68)
Intestine Small, Ileum (66) (63) (67) (68)
Sarcoma 1 (1%)
Liver (70) (70) (70) (70)
Hepatocellular Adenoma 1 (1%)
Sarcoma Stromal, Metastatic, Uterus 1 (1%)
Mesentery (4) (7) (9) (3)
Sarcoma Stromal, Metastatic, Uterus 1 (25%)
Pancreas (70) (69) (70) (70)
Sarcoma Stromal, Metastatic, Uterus 1 (1%)
Salivary Glands (70) (70) (70) (70)
Stomach, Forestomach (70) (68) (70) (70)
Squamous Cell Papilloma 1 (1%)
Stomach, Glandular (70) (69) (70) (70)
Tongue (1) (1)
Squamous Cell Papilloma 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (70) (70) (70) (70)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Medulla (70) (69) (70) (70)
Pheochromocytoma Malignant 1 (1%) 2 (3%)
Pheochromocytoma Benign 3 (4%) 3 (4%) 3 (4%) 3 (4%)
Islets, Pancreatic (70) (69) (70) (70)
Adenoma 2 (3%) 1 (1%) 2 (3%)
Parathyroid Gland (67) (66) (65) (61)
Adenoma 1 (2%)
Pituitary Gland (70) (69) (69) (67)
Pars Distalis, Adenoma 28 (40%) 30 (43%) 17 (25%) 22 (33%)
Pars Distalis, Adenoma, Multiple 3 (4%) 5 (7%) 3 (4%)
Pars Distalis, Carcinoma 1 (1%)
Thyroid Gland (70) (70) (70) (70)
C-Cell, Adenoma 4 (6%) 8 (11%) 7 (10%) 4 (6%)
C-Cell, Carcinoma 1 (1%) 2 (3%) 1 (1%)
Follicular Cell, Adenoma 1 (1%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (65) (68) (69) (69)
Adenoma 1 (2%) 1 (1%) 1 (1%)
Ovary (70) (70) (70) (70)
Adenoma, Tubular 1 (1%)
Granulosa Cell Tumor Benign 1 (1%)
Uterus (70) (70) (70) (70)
Leiomyoma 1 (1%)
Polyp Stromal 5 (7%) 9 (13%) 11 (16%) 8 (11%)
Polyp Stromal, Two 1 (1%)
Sarcoma Stromal 2 (3%) 1 (1%) 1 (1%) 1 (1%)
Vagina (1) (1) (4) (1)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (2) (1) (1)
Bone Marrow (70) (70) (70) (70)
Lymph Node (8) (6) (12) (8)
Lymph Node, Mandibular (70) (70) (70) (69)
Fibrosarcoma, Metastatic, Skin 1 (1%)
Lymph Node, Mesenteric (70) (69) (68) (70)
Sarcoma Stromal, Metastatic, Uterus 1 (1%)
Page 3
NTP Experiment-Test: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Spleen (70) (69) (70) (70)
Thymus (68) (68) (70) (65)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (69) (69) (66) (70)
Adenocarcinoma 1 (1%) 4 (6%) 1 (2%) 1 (1%)
Adenoma 1 (2%)
Fibroadenoma 10 (14%) 12 (17%) 6 (9%) 3 (4%)
Fibroadenoma, Multiple 5 (7%) 1 (1%) 2 (3%)
Fibrosarcoma 1 (1%)
Skin (70) (70) (69) (70)
Basal Cell Adenoma 1 (1%) 1 (1%) 1 (1%)
Fibroma 2 (3%)
Fibrosarcoma 1 (1%)
Keratoacanthoma 1 (1%)
Sarcoma 1 (1%) 1 (1%)
Trichoepithelioma 1 (1%)
Pinna, Neurofibroma 1 (1%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (70) (70) (70) (70)
Osteosarcoma 1 (1%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (70) (70) (69) (70)
Astrocytoma Malignant 1 (1%)
Carcinoma, Metastatic, Pituitary Gland 1 (1%)
Spinal Cord (1) (1)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (70) (70) (70) (70)
Alveolar/Bronchiolar Adenoma 3 (4%)
Carcinoma, Metastatic, Thyroid Gland 1 (1%)
Fibrosarcoma, Metastatic, Skin 1 (1%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (1%)
Squamous Cell Carcinoma, Metastatic, Ear 1 (1%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Squamous Cell Carcinoma, Metastatic, Ear 1 (100%)
Zymbal's Gland (1) (1) (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (70) (69) (68) (69)
Lipoma 1 (1%)
Renal Tubule, Adenoma 1 (1%) 2 (3%)
Urinary Bladder (67) (64) (67) (68)
Papilloma 1 (1%) 1 (1%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(70) *(70) *(70) *(70)
Leukemia Mononuclear 13 (19%) 14 (20%) 14 (20%) 13 (19%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 51 50 46
Total Primary Neoplasms 77 105 77 75
Total Animals with Benign Neoplasms 43 48 42 38
Total Benign Neoplasms 59 80 56 57
Total Animals with Malignant Neoplasms 18 22 20 17
Total Malignant Neoplasms 18 25 21 18
Total Animals with Metastatic Neoplasms 2 3 1
Total Metastatic Neoplasm 7 4 1
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: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 70 70 70 70
Scheduled Sacrifice 20 20 20 19
Early Deaths
Moribund Sacrifice 14 9 7 9
Natural Death 8 7 9 8
Accidently Killed 1
Survivors
Terminal Sacrifice 28 33 34 33
Natural Death 1
Animals Examined Microscopically 70 70 70 70
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (66) (66) (65) (66)
Intestine Large, Rectum (68) (67) (68) (69)
Intestine Large, Cecum (66) (64) (64) (63)
Lipoma 1 (2%)
Polyp 1 (2%)
Intestine Small, Duodenum (66) (69) (66) (67)
Intestine Small, Jejunum (65) (66) (64) (65)
Intestine Small, Ileum (66) (63) (62) (64)
Liver (70) (70) (70) (70)
Hepatocellular Adenoma 2 (3%)
Histiocytic Sarcoma 1 (1%)
Mesentery (6) (7) (14) (14)
Pancreas (69) (70) (69) (69)
Acinus, Adenoma 2 (3%) 1 (1%)
Stomach, Glandular (68) (70) (68) (70)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (70) (70) (70) (70)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (70) (69) (69) (69)
Adenoma 1 (1%)
Adrenal Medulla (69) (68) (69) (69)
Pheochromocytoma Malignant 1 (1%) 1 (1%) 1 (1%)
Pheochromocytoma Benign 12 (17%) 5 (7%) 5 (7%) 11 (16%)
Page 7
NTP Experiment-Test: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Bilateral, Pheochromocytoma Benign 5 (7%) 1 (1%)
Islets, Pancreatic (69) (70) (70) (69)
Adenoma 1 (1%) 1 (1%) 2 (3%)
Carcinoma 2 (3%) 2 (3%)
Parathyroid Gland (67) (66) (68) (63)
Adenoma 1 (2%)
Pituitary Gland (68) (69) (68) (70)
Pars Distalis, Adenoma 11 (16%) 11 (16%) 7 (10%) 11 (16%)
Pars Distalis, Adenoma, Multiple 1 (1%)
Pars Distalis, Carcinoma 1 (1%)
Thyroid Gland (70) (69) (70) (69)
Schwannoma Malignant, Metastatic, Skin 1 (1%)
Bilateral, C-Cell, Adenoma 1 (1%)
C-Cell, Adenoma 4 (6%) 5 (7%) 6 (9%) 8 (12%)
C-Cell, Carcinoma 1 (1%) 2 (3%) 1 (1%)
Follicular Cell, Adenoma 1 (1%)
Follicular Cell, Carcinoma 1 (1%) 1 (1%) 1 (1%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Coagulating Gland (1)
Adenoma 1 (100%)
Epididymis (70) (69) (70) (70)
Preputial Gland (70) (67) (70) (70)
Adenoma 2 (3%) 2 (3%) 2 (3%) 1 (1%)
Carcinoma 2 (3%) 4 (6%) 2 (3%)
Prostate (69) (70) (69) (70)
Seminal Vesicle (68) (70) (69) (70)
Testes (70) (69) (70) (70)
Bilateral, Interstitial Cell, Adenoma 50 (71%) 47 (68%) 51 (73%) 51 (73%)
Interstitial Cell, Adenoma 5 (7%) 9 (13%) 4 (6%) 6 (9%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1)
Bone Marrow (69) (70) (70) (70)
Histiocytic Sarcoma 1 (1%)
Osteosarcoma, Metastatic, Bone 1 (1%)
Lymph Node (12) (19) (16) (11)
Mediastinal, Histiocytic Sarcoma 1 (9%)
Page 8
NTP Experiment-Test: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Pancreatic, Histiocytic Sarcoma 1 (9%)
Lymph Node, Mandibular (68) (69) (68) (70)
Histiocytic Sarcoma 1 (1%)
Lymph Node, Mesenteric (69) (70) (68) (69)
Histiocytic Sarcoma 1 (1%)
Spleen (70) (70) (70) (70)
Hemangiosarcoma 2 (3%)
Histiocytic Sarcoma 1 (1%)
Thymus (59) (67) (67) (68)
Histiocytic Sarcoma 1 (1%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (57) (53) (53) (61)
Fibroadenoma 1 (2%) 2 (4%) 1 (2%) 2 (3%)
Skin (70) (70) (68) (70)
Basal Cell Adenoma 2 (3%)
Fibroma 1 (1%) 3 (4%) 1 (1%) 3 (4%)
Fibrosarcoma 1 (1%)
Keratoacanthoma 1 (1%) 1 (1%) 4 (6%) 1 (1%)
Sarcoma 1 (1%) 1 (1%)
Squamous Cell Papilloma 1 (1%) 1 (1%)
Subcutaneous Tissue, Schwannoma Malignant 1 (1%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (69) (70) (70) (70)
Chordoma 1 (1%)
Osteosarcoma 1 (1%)
Skeletal Muscle (1) (6)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (70) (70) (70) (70)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (70) (70) (70) (70)
Alveolar/Bronchiolar Adenoma 2 (3%) 1 (1%)
Histiocytic Sarcoma 1 (1%)
Schwannoma Malignant, Metastatic, Skin 1 (1%)
Nose (70) (69) (69) (70)
Polyp 1 (1%)
Page 9
NTP Experiment-Test: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM - cont
Squamous Cell Carcinoma 1 (1%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (3) (1)
Carcinoma, Metastatic, Pituitary Gland 1 (33%)
Zymbal's Gland (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (69) (70) (70) (67)
Lipoma 1 (1%)
Sarcoma 1 (1%)
Renal Tubule, Adenoma 1 (1%)
Urinary Bladder (63) (64) (63) (64)
Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(70) *(70) *(70) *(70)
Histiocytic Sarcoma 1 (1%)
Leukemia Mononuclear 29 (41%) 25 (36%) 17 (24%) 23 (33%)
Mesothelioma Malignant 1 (1%) 3 (4%) 2 (3%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05150-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC METHLYPHENIDATE HYDROCHLORIDE Date: 05/20/95
Route: DOSED FEED Time: 09:09:25
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 100 PPM 500 PPM 1000 PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 57 57 56 57
Total Primary Neoplasms 135 126 118 137
Total Animals with Benign Neoplasms 56 57 55 57
Total Benign Neoplasms 98 94 85 104
Total Animals with Malignant Neoplasms 32 28 27 30
Total Malignant Neoplasms 37 32 33 33
Total Animals with Metastatic Neoplasms 1 4 1
Total Metastatic Neoplasm 1 5 1
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 11
------------------------------------------------------------
---------- END OF REPORT ----------
------------------------------------------------------------