TDMS Study 05093-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
P-NITROANILINE
NTP Experiment-Test: 05093-01 Report: PEIRPT05
Study Type: CHRONIC Date: 09/12/94
Route: GAVAGE Time: 21:13:10
Facility: Southern Research Institute
Chemical CAS #: 100-01-6
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: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 10 10 50 10 10
Scheduled Sacrifice 9 9 10 10
Early Deaths
Accidently Killed 1
Moribund Sacrifice 16 5
Natural Death 4 1 4
Drowned 1
Survivors
Terminal Sacrifice 29 41
Animals Examined Microscopically 50 10 10 50 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (49) (10) (9) (50)
Intestine Small, Duodenum (50) (10) (10) (50)
Polyp Adenomatous 1 (2%)
Intestine Small, Ileum (50) (9) (10) (50)
Intestine Small, Jejunum (50) (10) (10) (50)
Adenocarcinoma 2 (4%)
Liver (50) (10) (10) (50) (10) (10)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%) 1 (2%)
Hepatocellular Carcinoma 7 (14%) 1 (10%) 6 (12%)
Hepatocellular Adenoma 9 (18%) 1 (10%) 9 (18%) 1 (10%)
Hepatocellular Adenoma, Multiple, Two 3 (6%) 1 (2%)
Hepatocellular Adenoma, Multiple, Three 1 (2%) 2 (4%)
Hepatocholangiocarcinoma 1 (2%)
Mesentery (8) (2)
Sarcoma 1 (13%)
Pancreas (50) (10) (10) (50)
Salivary Glands (50) (10) (10) (50)
Stomach, Forestomach (50) (10) (10) (50)
Squamous Cell Papilloma 3 (6%) 3 (6%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (10) (10) (50)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (10) (10) (50) (1)
Spindle Cell, Adenoma 1 (2%)
Adrenal Gland, Medulla (50) (10) (10) (50) (1)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (50) (10) (10) (50)
Adenoma 1 (2%)
Pituitary Gland (48) (10) (9) (50) (1)
Pars Distalis, Adenoma 4 (8%) 3 (6%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (10) (10) (50) (10)
Follicular Cell, Adenoma 3 (6%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (47) (10) (10) (50)
Teratoma Benign 1 (2%)
Granulosa Cell, Adenoma 1 (2%)
Uterus (50) (10) (10) (50) (10) (8)
Adenocarcinoma 1 (2%)
Polyp Stromal 3 (6%)
Sarcoma Stromal 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (10) (10) (50)
Lymph Node (50) (10) (10) (50)
Mediastinal, Osteosarcoma, Metastatic, Bone 1 (2%)
Lymph Node, Mandibular (48) (9) (10) (49)
Lymph Node, Mesenteric (50) (9) (10) (47)
Spleen (50) (10) (10) (49) (10) (10)
Hemangiosarcoma 1 (2%)
Thymus (49) (10) (10) (48)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (10) (10) (50) (1) (1)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (10) (10) (50)
Osteosarcoma 1 (2%) 1 (2%)
Skeletal Muscle (2)
Carcinoma, Metastatic, Harderian Gland 1 (50%)
Osteosarcoma, Metastatic, Bone 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (10) (10) (49)
Glioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (10) (50) (10)
Alveolar/Bronchiolar Adenoma 2 (4%) 5 (10%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 1 (10%) 2 (4%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Nose (50) (10) (10) (50)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (4) (3)
Adenoma 3 (75%) 3 (100%)
Carcinoma 1 (25%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (10) (10) (50) (1)
Urinary Bladder (50) (10) (10) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(10) *(10) *(50) *(10) *(10)
Lymphoma Malignant Histiocytic 1 (2%)
* Number of animals with any tissue examined microscopically
Page 4
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS - cont
Multiple Organs *(50) *(10) *(10) *(50) *(10) *(10)
Lymphoma Malignant Lymphocytic 1 (2%)
Lymphoma Malignant Mixed 9 (18%) 3 (6%)
____________________________________________________________________________________________________________________________________
Page 5
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 35 2 33 1
Total Primary Neoplasms 54 2 54 1
Total Animals with Benign Neoplasms 23 1 25 1
Total Benign Neoplasms 29 1 36 1
Total Animals with Malignant Neoplasms 21 1 14
Total Malignant Neoplasms 25 1 18
Total Animals with Metastatic Neoplasms 3 1 2
Total Metastatic Neoplasm 6 1 2
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: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 10 10 50 10 10
Scheduled Sacrifice 9 10 10 9
Early Deaths
Moribund Sacrifice 11 12
Natural Death 5 5 1
Accidently Killed 1 1
Dosing Accident 1 1
Survivors
Terminal Sacrifice 32 32
Animals Examined Microscopically 50 10 10 50 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Gallbladder (50) (1) (43) (10) (10)
Intestine Small, Ileum (49) (1) (50) (10) (9)
Intestine Small, Jejunum (50) (1) (50) (10) (9)
Adenocarcinoma 1 (2%)
Liver (50) (10) (10) (50) (10) (10)
Cholangiocarcinoma 1 (2%)
Hepatocellular Carcinoma 10 (20%) 7 (14%)
Hepatocellular Carcinoma, Multiple, Two 2 (4%)
Hepatocellular Adenoma 14 (28%) 8 (16%) 1 (10%)
Hepatocellular Adenoma, Multiple, Two 1 (2%) 1 (2%)
Hepatocellular Adenoma, Multiple, Three 1 (2%)
Mesentery (9) (6)
Cholangiocarcinoma, Multiple, Metastatic,
Greater Than Five, Liver 1 (11%)
Hemangiosarcoma 1 (11%)
Pancreas (50) (1) (50) (10) (10)
Salivary Glands (50) (1) (49) (9) (10)
Stomach, Forestomach (50) (1) (50) (10) (10)
Cholangiocarcinoma, Metastatic, Liver 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%) 2 (4%)
Stomach, Glandular (50) (1) (50) (10) (10)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (1) (50) (10) (10)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (1) (50) (10) (10)
Adrenal Gland, Medulla (50) (1) (50) (10) (10)
Pheochromocytoma Benign 2 (4%)
Islets, Pancreatic (50) (1) (50) (10) (10)
Adenoma 1 (2%) 1 (2%)
Pituitary Gland (48) (1) (48) (9) (9)
Pars Distalis, Adenoma 5 (10%) 2 (4%)
Thyroid Gland (50) (10) (50) (10) (10)
Follicular Cell, Adenoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (1)
Ovary (49) (1) (1) (48) (10) (10)
Cystadenoma 1 (2%)
Hemangioma 1 (2%) 1 (2%)
Mixed Tumor Benign 1 (2%)
Teratoma Benign 1 (100%)
Granulosa Cell, Adenoma 1 (2%)
Uterus (50) (10) (8) (50) (10) (10)
Polyp Stromal 1 (2%)
Sarcoma Stromal 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (1) (50) (10) (10)
Hemangiosarcoma 1 (2%)
Lymph Node (50) (1) (50) (10) (10)
Lymph Node, Mandibular (50) (1) (47) (9) (10)
Lymph Node, Mesenteric (49) (1) (45) (10) (10)
Spleen (50) (10) (10) (50) (10) (10)
Hemangioma 1 (2%)
Hemangiosarcoma 1 (2%) 2 (4%)
Histiocytic Sarcoma 1 (2%)
Page 8
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Thymus (48) (1) (48) (8) (10)
Schwannoma NOS 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (2) (2) (50) (10) (10)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 3 (6%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (1) (50) (10) (10)
Hemangiosarcoma 1 (2%)
Skeletal Muscle (1)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (1) (50) (10) (10)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (10) (50) (10) (10)
Alveolar/Bronchiolar Adenoma 4 (8%) 3 (6%)
Alveolar/Bronchiolar Carcinoma 2 (4%) 1 (2%)
Cholangiocarcinoma, Multiple, Metastatic,
Greater Than Five, Liver 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%) 3 (6%)
Schwannoma NOS 1 (2%)
Mediastinum, Schwannoma NOS 1 (2%)
Nose (50) (1) (50) (10) (10)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (10) (7)
Adenoma 4 (40%) 5 (71%)
Carcinoma 2 (20%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (1) (50) (10) (10)
Urinary Bladder (49) (1) (50) (10) (10)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(10) *(10) *(50) *(10) *(10)
Histiocytic Sarcoma 1 (2%)
Lymphoma Malignant Histiocytic 1 (2%) 1 (2%)
Lymphoma Malignant Lymphocytic 1 (2%)
Lymphoma Malignant Mixed 4 (8%) 5 (10%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 34 1 36 1
Total Primary Neoplasms 68 1 52 1
Total Animals with Benign Neoplasms 23 1 23 1
Total Benign Neoplasms 36 1 28 1
Total Animals with Malignant Neoplasms 20 22
Total Malignant Neoplasms 29 24
Total Animals with Metastatic Neoplasms 2 3
Total Metastatic Neoplasm 4 3
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 3
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Primary tumors: all tumors except metastatic tumors
Page 11
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 10 10 50 10 10
Scheduled Sacrifice 10 10 10 10
Early Deaths
Natural Death 4 4
Moribund Sacrifice 13 14
Survivors
Terminal Sacrifice 33 32
Animals Examined Microscopically 50 10 10 50 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (49) (10) (10) (49)
Fibrous Histiocytoma 1 (2%)
Intestine Small, Ileum (50) (10) (10) (50)
Polyp Adenomatous 1 (2%)
Intestine Small, Jejunum (50) (10) (10) (49)
Adenocarcinoma 2 (4%)
Liver (50) (10) (10) (50) (10) (10)
Cholangiocarcinoma, Multiple, Two 1 (2%)
Hemangiosarcoma 1 (2%)
Hepatocellular Carcinoma 8 (16%) 10 (20%) 1 (10%)
Hepatocellular Carcinoma, Multiple, Two 2 (4%) 2 (4%)
Hepatocellular Adenoma 11 (22%) 12 (24%) 1 (10%)
Hepatocellular Adenoma, Multiple, Two 8 (16%) 1 (10%) 6 (12%) 1 (10%)
Ito Cell Tumor Benign, Multiple, Two 1 (2%)
Mesentery (2) (4) (1)
Cholangiocarcinoma, Metastatic, Liver 1 (25%)
Hemangioma 1 (25%)
Hemangiosarcoma 1 (50%)
Pancreas (50) (10) (10) (50)
Cholangiocarcinoma, Metastatic, Liver 1 (2%)
Sarcoma 1 (2%)
Stomach, Forestomach (50) (10) (10) (50) (10)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 3 (6%) 1 (10%) 2 (4%)
____________________________________________________________________________________________________________________________________
Page 12
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (10) (10) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (10) (10) (50)
Spindle Cell, Adenoma 1 (2%)
Adrenal Gland, Medulla (50) (10) (10) (50)
Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (50) (10) (10) (50)
Adenoma 1 (2%)
Pituitary Gland (48) (9) (8) (47)
Pars Distalis, Adenoma 1 (2%)
Thyroid Gland (50) (10) (10) (50) (10) (1)
Follicular Cell, Adenoma 1 (2%) 1 (2%)
Follicular Cell, Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (10) (10) (50)
Prostate (49) (10) (10) (49)
Seminal Vesicle (50) (10) (10) (50)
Cholangiocarcinoma, Metastatic, Liver 1 (2%)
Testes (50) (10) (10) (50)
Interstitial Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (10) (10) (50) (10) (10)
Hemangiosarcoma 1 (2%)
Lymph Node (50) (10) (10) (50)
Mediastinal, Cholangiocarcinoma, Metastatic,
Liver 1 (2%)
Lymph Node, Mandibular (50) (7) (10) (48)
Lymph Node, Mesenteric (49) (8) (10) (47)
Hemangiosarcoma 1 (2%)
Spleen (50) (10) (10) (50) (10) (10)
Hemangioma 1 (2%)
Hemangiosarcoma 4 (8%)
Page 13
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Histiocytic Sarcoma 1 (2%)
Thymus (46) (10) (10) (47)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (10) (10) (50) (1)
Subcutaneous Tissue, Fibrosarcoma 2 (4%)
Subcutaneous Tissue, Hemangioma 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1)
Cholangiocarcinoma, Metastatic, Liver 1 (100%)
Fibrosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (10) (50) (10) (10)
Alveolar/Bronchiolar Adenoma 6 (12%) 7 (14%)
Alveolar/Bronchiolar Adenoma, Multiple, Two 1 (2%)
Alveolar/Bronchiolar Carcinoma 5 (10%) 2 (4%)
Alveolar/Bronchiolar Carcinoma, Multiple, Two 1 (2%)
Carcinoma, Metastatic, Harderian Gland 1 (2%)
Cholangiocarcinoma, Metastatic, Liver 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 2 (4%)
Mediastinum, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2) (1)
Fibrosarcoma 1 (50%)
Hemangiosarcoma 1 (50%)
Harderian Gland (8) (6)
Adenoma 4 (50%) 5 (83%)
Page 14
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM - cont
Carcinoma 1 (13%) 2 (33%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (10) (10) (50)
Urinary Bladder (50) (10) (10) (50) (1)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(10) *(10) *(50) *(10) *(10)
Histiocytic Sarcoma 1 (2%)
Lymphoma Malignant Histiocytic 1 (2%)
Lymphoma Malignant Lymphocytic 1 (10%)
Lymphoma Malignant Mixed 4 (8%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 15
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE VEHICLE VEHICLE VEHICLE 3 MG/KG 3 MG/KG 3 MG/KG
CONTROL 9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 33 3 38 3
Total Primary Neoplasms 70 3 67 4
Total Animals with Benign Neoplasms 27 2 32 2
Total Benign Neoplasms 36 2 41 2
Total Animals with Malignant Neoplasms 23 1 22 2
Total Malignant Neoplasms 34 1 26 2
Total Animals with Metastatic Neoplasms 2 3
Total Metastatic Neoplasm 3 8
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 16
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50 10 10 50 10 10
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund Sacrifice 10 10
Natural Death 3 1
Drowned 1
Survivors
Terminal Sacrifice 36 39
Animals Examined Microscopically 50 10 10 50 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Jejunum (50) (50) (10) (10)
Liver (50) (10) (10) (50) (10) (10)
Cholangiocarcinoma 1 (2%)
Hemangiosarcoma 2 (4%) 1 (10%) 4 (8%)
Hepatocellular Carcinoma 11 (22%) 1 (10%) 5 (10%) 1 (10%)
Hepatocellular Carcinoma, Multiple, Two 1 (2%) 1 (2%)
Hepatocellular Carcinoma, Multiple, Three 1 (2%)
Hepatocellular Adenoma 11 (22%) 1 (10%) 8 (16%)
Hepatocellular Adenoma, Multiple, Two 3 (6%) 1 (2%) 1 (10%)
Hepatocellular Adenoma, Multiple, Three 1 (2%)
Hepatocellular Adenoma, Multiple, Four 1 (2%)
Mesentery (6) (1)
Cholangiocarcinoma, Metastatic, Liver 1 (17%)
Fibrosarcoma 1 (17%)
Pancreas (50) (49) (10) (10)
Cholangiocarcinoma, Metastatic, Liver 1 (2%)
Fibrosarcoma, Metastatic, Mesentery 1 (2%)
Stomach, Forestomach (50) (10) (50) (10) (10)
Squamous Cell Papilloma 2 (4%) 2 (4%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
Page 17
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (10) (10)
Spindle Cell, Adenoma 1 (2%)
Adrenal Gland, Medulla (50) (50) (10) (10)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%) 1 (2%)
Islets, Pancreatic (50) (49) (10) (10)
Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (10) (10)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (50) (10) (10) (50) (10) (10)
Hemangiosarcoma 1 (2%) 2 (4%)
Lymph Node (50) (1) (49) (10) (10)
Lymph Node, Mandibular (49) (48) (10) (9)
Lymph Node, Mesenteric (49) (1) (45) (10) (10)
Spleen (50) (10) (10) (50) (10) (10)
Hemangioma 1 (2%) 1 (2%)
Hemangiosarcoma 2 (4%) 2 (4%)
Histiocytic Sarcoma 1 (2%)
Thymus (49) (47) (8) (10)
Mediastinum, Hemangiosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (50) (2) (50) (10) (10)
Sebaceous Gland, Adenoma 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 18
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2) (1)
Fibrosarcoma, Metastatic, Mesentery 1 (50%)
Hemangiosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (10) (10) (50) (10) (10)
Alveolar/Bronchiolar Adenoma 6 (12%) 3 (6%) 1 (10%)
Alveolar/Bronchiolar Adenoma, Multiple, Two 2 (4%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 6 (12%)
Carcinoma, Metastatic, Harderian Gland 2 (4%)
Cholangiocarcinoma, Metastatic, Liver 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 2 (4%) 2 (4%)
Nose (50) (50) (10) (10)
Polyp 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2)
Fibrosarcoma 2 (100%)
Harderian Gland (4) (9)
Adenoma 3 (75%) 7 (78%)
Carcinoma 2 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (10) (50) (10) (10)
Urinary Bladder (50) (10) (50) (10) (10)
Hemangioma 1 (10%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(10) *(10) *(50) *(10) *(10)
Histiocytic Sarcoma 1 (2%)
Lymphoma Malignant Histiocytic 1 (2%)
Lymphoma Malignant Mixed 3 (6%)
* Number of animals with any tissue examined microscopically
Page 19
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS - cont
Multiple Organs *(50) *(10) *(10) *(50) *(10) *(10)
____________________________________________________________________________________________________________________________________
Page 20
NTP Experiment-Test: 05093-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC P-NITROANILINE Date: 09/12/94
Route: GAVAGE Time: 21:13:10
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE 30 MG/KG 30 MG/KG 30 MG/KG 100MG/KG 100MG/KG 100MG/KG
9 SSAC 15 SSAC 9 SSAC 15 SSAC
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 36 3 28 1 2
Total Primary Neoplasms 66 3 46 1 3
Total Animals with Benign Neoplasms 26 1 19 1 2
Total Benign Neoplasms 35 1 24 1 2
Total Animals with Malignant Neoplasms 20 2 15 1
Total Malignant Neoplasms 31 2 22 1
Total Animals with Metastatic Neoplasms 5 2
Total Metastatic Neoplasm 9 2
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 21
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