TDMS Study 05068-09 Pathology Tables
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
Facility: Microbiological Associates
Chemical CAS #: 76-57-3
Lock Date: 04/19/94
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: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 9 9
Early Deaths
Moribund Sacrifice 15 9 17 14
Natural Death 7 3 5 5
Survivors
Moribund Sacrifice 1 1
Terminal Sacrifice 28 37 28 32
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (60)
Intestine Large, Colon (60) (60) (60) (60)
Intestine Large, Rectum (60) (60) (60) (60)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Intestine Large, Cecum (60) (58) (59) (59)
Intestine Small, Duodenum (60) (60) (60) (59)
Intestine Small, Jejunum (59) (59) (56) (59)
Adenocarcinoma 1 (2%)
Intestine Small, Ileum (60) (58) (57) (56)
Liver (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Mesentery (8) (5) (6) (3)
Oral Mucosa (3) (1)
Buccal, Squamous Cell Carcinoma 1 (100%)
Pancreas (60) (60) (60) (60)
Salivary Glands (60) (59) (60) (59)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Stomach, Forestomach (60) (60) (60) (59)
Stomach, Glandular (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (60) (60) (60) (60)
Heart (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Adenoma 1 (2%) 1 (2%)
Adrenal Medulla (60) (60) (59) (60)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 2 (3%) 5 (8%) 1 (2%) 1 (2%)
Islets, Pancreatic (60) (60) (60) (60)
Adenoma 1 (2%) 1 (2%)
Carcinoma 1 (2%)
Parathyroid Gland (53) (44) (47) (52)
Adenoma 1 (2%)
Pituitary Gland (56) (60) (59) (60)
Pars Distalis, Adenoma 17 (30%) 18 (30%) 20 (34%) 12 (20%)
Pars Distalis, Carcinoma 1 (2%) 1 (2%)
Thyroid Gland (60) (60) (60) (60)
Bilateral, Follicular Cell, Carcinoma 1 (2%)
C-Cell, Adenoma 4 (7%) 3 (5%) 5 (8%) 3 (5%)
C-Cell, Carcinoma 2 (3%) 1 (2%)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (57) (57) (59) (60)
Adenoma 5 (9%) 5 (9%) 11 (19%) 1 (2%)
Carcinoma 1 (2%)
Bilateral, Adenoma 1 (2%) 1 (2%)
Ovary (60) (60) (60) (60)
Granulosa-Theca Tumor Malignant 1 (2%)
Luteoma 1 (2%)
Oviduct (1)
Uterus (60) (60) (60) (60)
Polyp Stromal 1 (2%) 7 (12%) 7 (12%) 3 (5%)
Sarcoma 1 (2%)
Sarcoma Stromal 1 (2%)
Vagina (2) (1)
Squamous Cell Papilloma 1 (50%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Lymph Node (12) (10) (9) (11)
Mediastinal, Histiocytic Sarcoma 1 (11%)
Lymph Node, Mandibular (58) (59) (58) (58)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Lymph Node, Mesenteric (60) (59) (58) (60)
Spleen (60) (60) (60) (60)
Histiocytic Sarcoma 1 (2%)
Thymus (52) (56) (56) (54)
Thymoma Benign 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (60) (60) (59) (60)
Adenoacanthoma 1 (2%)
Adenocarcinoma 3 (5%) 2 (3%) 3 (5%)
Fibroadenoma 22 (37%) 20 (33%) 21 (36%) 6 (10%)
Fibroadenoma, Multiple 5 (8%) 1 (2%) 6 (10%) 2 (3%)
Skin (60) (60) (59) (60)
Keratoacanthoma 1 (2%)
Squamous Cell Papilloma 1 (2%)
Subcutaneous Tissue, Fibroma 2 (3%) 3 (5%) 1 (2%)
Subcutaneous Tissue, Fibroma, Multiple 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
Tail, Keratoacanthoma 1 (2%)
Tail, Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Astrocytoma Benign 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%)
Spinal Cord (2)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (60) (60) (60)
Alveolar/Bronchiolar Adenoma 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%)
Chordoma, Metastatic, Uncertain Primary Site 1 (2%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Nose (60) (60) (60) (60)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Sarcoma 1 (2%)
Nasolacrimal Duct, Squamous Cell Carcinoma 1 (2%)
Trachea (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2)
Pinna, Schwannoma Malignant 2 (100%)
Zymbal's Gland (1) (3) (1)
Carcinoma 1 (100%) 3 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Lipoma 1 (2%)
Nephroblastoma 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
Urinary Bladder (60) (59) (59) (59)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 15 (25%) 16 (27%) 18 (30%) 12 (20%)
Lymphoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 48 46 50 37
Total Primary Neoplasms 93 86 115 51
Total Animals with Benign Neoplasms 39 42 44 27
Total Benign Neoplasms 64 65 80 32
Total Animals with Malignant Neoplasms 28 19 28 17
Total Malignant Neoplasms 29 21 35 19
Total Animals with Metastatic Neoplasms 1 3 1
Total Metastatic Neoplasm 1 5 2
Total Animals with Malignant Neoplasms 1 1
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: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 14 23 24 23
Natural Death 7 7 5 7
Survivors
Terminal Sacrifice 29 20 21 20
Animals Examined Microscopically 60 60 60 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (60) (60) (60) (60)
Intestine Large, Colon (60) (60) (60) (60)
Polyp Adenomatous 1 (2%)
Polyp Adenomatous, Multiple 1 (2%)
Intestine Large, Rectum (59) (58) (60) (60)
Intestine Large, Cecum (57) (58) (59) (60)
Adenoma 1 (2%) 1 (2%)
Intestine Small, Duodenum (58) (59) (60) (58)
Sarcoma, Metastatic, Mesentery 1 (2%)
Intestine Small, Jejunum (56) (58) (57) (56)
Adenocarcinoma 1 (2%)
Intestine Small, Ileum (56) (56) (57) (57)
Liver (60) (60) (60) (60)
Hepatocellular Carcinoma 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%)
Hepatocellular Adenoma, Multiple 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Sarcoma, Metastatic, Mesentery 1 (2%)
Mesentery (13) (24) (24) (21)
Sarcoma 1 (5%)
Pancreas (60) (60) (60) (60)
Sarcoma, Metastatic, Mesentery 1 (2%)
Salivary Glands (60) (60) (60) (60)
Stomach, Forestomach (60) (60) (60) (60)
Sarcoma, Metastatic, Mesentery 1 (2%)
Stomach, Glandular (59) (60) (60) (60)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Blood Vessel (59) (60) (60) (60)
Heart (60) (60) (60) (60)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (60) (60) (60) (60)
Adenoma 1 (2%)
Adrenal Medulla (59) (60) (59) (60)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Complex 1 (2%)
Pheochromocytoma Benign 13 (22%) 7 (12%) 5 (8%) 3 (5%)
Bilateral, Pheochromocytoma Malignant 1 (2%)
Bilateral, Pheochromocytoma Benign 3 (5%) 1 (2%)
Islets, Pancreatic (60) (60) (60) (60)
Adenoma 3 (5%)
Parathyroid Gland (48) (51) (52) (53)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Pituitary Gland (60) (60) (58) (57)
Pars Distalis, Adenoma 10 (17%) 5 (8%) 6 (10%) 4 (7%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (60) (60) (60) (60)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 3 (5%) 3 (5%) 2 (3%) 1 (2%)
C-Cell, Carcinoma 2 (3%) 2 (3%) 4 (7%) 3 (5%)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (60) (59) (59)
Penis (1) (1)
Preputial Gland (59) (60) (58) (59)
Adenoma 3 (5%) 6 (10%) 5 (9%) 2 (3%)
Carcinoma 1 (2%)
Bilateral, Adenoma 2 (3%)
Prostate (59) (59) (60) (60)
Seminal Vesicle (60) (60) (60) (60)
Page 8
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Sarcoma, Metastatic, Mesentery 1 (2%)
Testes (60) (60) (60) (60)
Bilateral, Interstitial Cell, Adenoma 40 (67%) 45 (75%) 49 (82%) 55 (92%)
Interstitial Cell, Adenoma 13 (22%) 12 (20%) 7 (12%) 2 (3%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (60) (60) (60)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Lymph Node (20) (17) (15) (22)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (6%)
Mediastinal, Sarcoma, Metastatic, Mesentery 1 (5%)
Lymph Node, Mandibular (60) (59) (59) (59)
Lymph Node, Mesenteric (60) (60) (60) (60)
Spleen (60) (60) (60) (60)
Sarcoma, Metastatic, Mesentery 1 (2%)
Thymus (56) (51) (49) (50)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (57) (59) (60) (56)
Fibroadenoma 1 (2%) 1 (2%) 1 (2%)
Skin (60) (60) (60) (59)
Keratoacanthoma 1 (2%) 2 (3%) 2 (3%) 2 (3%)
Lipoma 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Trichoepithelioma 1 (2%)
Foot, Squamous Cell Papilloma 1 (2%)
Lip, Basosquamous Tumor Benign 1 (2%)
Subcutaneous Tissue, Fibroma 5 (8%) 2 (3%) 3 (5%) 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
Tail, Squamous Cell Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (60) (60) (60) (60)
Rib, Osteosarcoma 1 (2%)
Skeletal Muscle (1) (1) (1)
Abdominal, Sarcoma, Metastatic, Mesentery 1 (100%)
Back, Lipoma 1 (100%)
Thoracic, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (100%)
Page 9
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (60) (60) (60)
Astrocytoma Malignant 1 (2%) 1 (2%)
Meningioma Malignant 1 (2%)
Spinal Cord (1) (2)
Hemangioma 1 (50%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (59) (60) (60)
Alveolar/Bronchiolar Adenoma 2 (3%)
Alveolar/Bronchiolar Carcinoma 2 (3%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Sarcoma, Metastatic, Mesentery 1 (2%)
Schwannoma Malignant, Metastatic, Ear 1 (2%) 1 (2%) 2 (3%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
Nose (60) (60) (60) (60)
Adenoma 2 (3%)
Chondroma 1 (2%)
Trachea (60) (60) (60) (60)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1) (1) (2)
Schwannoma Malignant 1 (50%)
Pinna, Schwannoma Malignant 1 (100%) 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (60) (60) (60)
Sarcoma, Metastatic, Mesentery 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
Urinary Bladder (60) (59) (58) (59)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(60) *(60) *(60)
Leukemia Mononuclear 33 (55%) 27 (45%) 37 (62%) 37 (62%)
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS - cont
Multiple Organs *(60) *(60) *(60) *(60)
Mesothelioma Malignant 1 (2%) 2 (3%) 3 (5%) 3 (5%)
____________________________________________________________________________________________________________________________________
Page 11
NTP Experiment-Test: 05068-09 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CODEINE Date: 04/02/96
Route: DOSED FEED Time: 14:01:23
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 400 PPM 800 PPM 1600
PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 57 60 59 59
Total Primary Neoplasms 140 129 137 125
Total Animals with Benign Neoplasms 56 57 57 57
Total Benign Neoplasms 99 93 88 76
Total Animals with Malignant Neoplasms 37 33 41 41
Total Malignant Neoplasms 41 36 49 49
Total Animals with Metastatic Neoplasms 2 2 4
Total Metastatic Neoplasm 5 4 13
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 ----------
------------------------------------------------------------