TDMS Study 05021-04 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
CI PIGMENT RED 23
NTP Experiment-Test: 05021-04 Report: PEIRPT05
Study Type: CHRONIC Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
Facility: Southern Research Institute
Chemical CAS #: 6471-49-4
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: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund 11 7 11 10
Dead 4 8 3 4
Accident 1
Survivors
Terminal Sacrifice 35 34 36 35
Missing 1
Animals Examined Microscopically 50 50 50 49
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (15) (14) (48)
Gallbladder (46) (12) (12) (46)
Intestine Large, Cecum (47) (47) (48) (46)
Leiomyoma 1 (2%)
Intestine Large, Colon (47) (47) (48) (46)
Intestine Large, Rectum (46) (48) (48) (46)
Intestine Small, Duodenum (46) (46) (47) (46)
Histiocytic Sarcoma 1 (2%)
Intestine Small, Ileum (46) (45) (48) (46)
Histiocytic Sarcoma 1 (2%)
Intestine Small, Jejunum (46) (46) (48) (47)
Histiocytic Sarcoma 1 (2%)
Liver (49) (49) (50) (48)
Granulosa Cell Tumor Malignant, Metastatic,
Ovary 1 (2%)
Hemangiosarcoma 1 (2%)
Hepatocellular Carcinoma 3 (6%) 4 (8%) 5 (10%) 2 (4%)
Hepatocellular Carcinoma, Multiple 1 (2%) 1 (2%)
Hepatocellular Adenoma 1 (2%) 5 (10%) 4 (8%) 1 (2%)
Hepatocellular Adenoma, Multiple 1 (2%)
Histiocytic Sarcoma 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Plasma Cell Tumor Malignant 1 (2%)
Mesentery (7) (4) (3)
Pheochromocytoma Malignant, Metastatic,
Adrenal Gland 1 (33%)
Pancreas (49) (14) (15) (47)
Histiocytic Sarcoma 1 (7%)
Plasma Cell Tumor Malignant 1 (7%)
Salivary Glands (49) (16) (14) (49)
Page 2
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - cont
Stomach, Forestomach (49) (49) (50) (49)
Plasma Cell Tumor Malignant 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Stomach, Glandular (48) (48) (50) (45)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (16) (14) (49)
Histiocytic Sarcoma 1 (7%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (49) (15) (14) (48)
Adrenal Gland, Cortex (49) (15) (14) (48)
Adenoma 1 (7%) 1 (2%)
Adrenal Gland, Medulla (49) (15) (14) (47)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (49) (15) (15) (47)
Adenoma 1 (2%) 1 (7%) 1 (7%)
Pituitary Gland (50) (23) (16) (47)
Pars Distalis, Adenoma 16 (32%) 7 (30%) 6 (38%) 11 (23%)
Pars Distalis, Carcinoma 2 (4%) 1 (6%) 2 (4%)
Thyroid Gland (50) (15) (14) (49)
Granulosa Cell Tumor Malignant, Metastatic,
Ovary 1 (2%)
Follicular Cell, Adenoma 2 (4%) 1 (7%) 3 (6%)
Follicular Cell, Adenoma, Minimal 1 (7%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (47) (20) (28) (48)
Cystadenocarcinoma 1 (2%)
Cystadenoma 1 (5%)
Granulosa-Theca Tumor Benign 1 (5%)
Histiocytic Sarcoma 1 (2%) 1 (4%)
Luteoma 1 (2%)
Mixed Tumor Malignant 1 (2%)
Plasma Cell Tumor Malignant 1 (5%)
Page 3
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Bilateral, Granulosa Cell Tumor Malignant 1 (2%)
Bilateral, Granulosa Cell Tumor Benign 1 (2%)
Uterus (49) (41) (39) (49)
Histiocytic Sarcoma 1 (2%)
Leiomyoma 1 (3%)
Leiomyosarcoma 1 (2%)
Polyp Stromal 1 (2%) 4 (10%) 4 (8%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (49) (49) (49)
Hemangiosarcoma 2 (4%) 2 (4%)
Histiocytic Sarcoma 1 (2%) 1 (2%)
Lymph Node (50) (48) (50) (49)
Iliac, Histiocytic Sarcoma 1 (2%)
Inguinal, Sarcoma, Metastatic, Skin 1 (2%)
Mediastinal, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
Mediastinal, Histiocytic Sarcoma 1 (2%) 1 (2%)
Mediastinal, Pheochromocytoma Malignant,
Metastatic, Adrenal Gland 1 (2%)
Mediastinal, Plasma Cell Tumor Malignant 1 (2%)
Mesenteric, Histiocytic Sarcoma 2 (4%)
Mesenteric, Plasma Cell Tumor Malignant 1 (2%)
Mesenteric, Sarcoma, Metastatic, Skin 1 (2%)
Renal, Hemangiosarcoma 1 (2%)
Renal, Histiocytic Sarcoma 1 (2%)
Renal, Plasma Cell Tumor Malignant 1 (2%)
Renal, Sarcoma, Metastatic, Skin 1 (2%)
Lymph Node, Mandibular (49) (18) (15) (49)
Histiocytic Sarcoma 1 (2%)
Plasma Cell Tumor Malignant 1 (6%)
Spleen (50) (21) (25) (48)
Hemangiosarcoma 2 (8%)
Histiocytic Sarcoma 1 (2%) 1 (4%) 1 (2%)
Plasma Cell Tumor Malignant 1 (5%)
Thymus (18) (7) (14) (39)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (49) (15) (15) (48)
Adenocarcinoma 1 (2%) 1 (7%)
Skin (49) (48) (48) (49)
Fibrosarcoma 1 (2%) 1 (2%)
Hemangiosarcoma 1 (2%)
Page 4
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Sarcoma 2 (4%) 1 (2%)
Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50) (16) (14) (49)
Pelvis, Osteosarcoma 1 (6%)
Vertebra, Granulosa Cell Tumor Malignant,
Metastatic, Ovary 1 (2%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (15) (14) (49)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (49) (49)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 2 (4%) 4 (8%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (2%) 1 (2%) 1 (2%)
Osteosarcoma, Metastatic, Bone 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Gland 1 (2%)
Plasma Cell Tumor Malignant 1 (2%)
Sarcoma, Metastatic, Skin 2 (4%) 1 (2%)
Nose (50) (15) (14) (49)
Vomeronasal Organ, Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (4)
Adenoma 2 (100%) 3 (75%)
Carcinoma 1 (25%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (17) (15) (49)
Histiocytic Sarcoma 1 (2%) 1 (7%) 1 (2%)
Plasma Cell Tumor Malignant 1 (6%)
Urinary Bladder (47) (15) (12) (46)
Page 5
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(49)
Histiocytic Sarcoma 2 (4%) 1 (2%) 1 (2%) 1 (2%)
Lymphoma Malignant 1 (2%)
Lymphoma Malignant Lymphocytic 2 (4%) 2 (4%)
Lymphoma Malignant Mixed 5 (10%) 4 (8%) 8 (16%) 7 (14%)
Lymphoma Malignant Undifferentiated Cell 3 (6%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 6
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE FEMALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 27 31 31 32
Total Primary Neoplasms 41 58 42 51
Total Animals with Benign Neoplasms 19 19 17 18
Total Benign Neoplasms 24 26 19 26
Total Animals with Malignant Neoplasms 14 20 21 18
Total Malignant Neoplasms 17 32 23 25
Total Animals with Metastatic Neoplasms 1 4 1 2
Total Metastatic Neoplasm 3 7 1 4
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 7
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 8 7 8 9
Early Deaths
Dead 10 22 8 6
Moribund 12 14 17 15
Survivors
Terminal Sacrifice 29 17 27 30
Missing 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Small, Duodenum (43) (36) (46) (45)
Polyp 1 (3%)
Intestine Small, Jejunum (42) (37) (47) (45)
Adenocarcinoma 1 (2%)
Lymphoid Tissue, Histiocytic Sarcoma 2 (5%)
Liver (49) (50) (50) (49)
Fibrosarcoma, Metastatic, Skin 1 (2%)
Hemangiosarcoma 4 (8%)
Hepatocellular Carcinoma 9 (18%) 6 (12%) 9 (18%) 11 (22%)
Hepatocellular Carcinoma, Multiple 3 (6%) 1 (2%) 1 (2%) 4 (8%)
Hepatocellular Adenoma 2 (4%) 1 (2%) 3 (6%) 6 (12%)
Hepatocellular Adenoma, Multiple 1 (2%) 1 (2%) 2 (4%)
Histiocytic Sarcoma 2 (4%) 2 (4%)
Mesentery (3) (2)
Pancreas (49) (31) (25) (47)
Salivary Glands (49) (32) (22) (48)
Fibrosarcoma, Metastatic, Skin 1 (2%)
Stomach, Forestomach (49) (48) (50) (48)
Mast Cell Tumor Malignant 1 (2%)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (49) (48) (50) (44)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (48) (32) (23) (48)
Adrenal Gland, Cortex (48) (32) (23) (48)
Adenoma 2 (4%) 3 (6%)
Histiocytic Sarcoma 1 (3%)
Adrenal Gland, Medulla (48) (32) (23) (48)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 1 (2%)
Pituitary Gland (41) (29) (22) (48)
Pars Distalis, Adenoma 2 (4%)
Thyroid Gland (49) (30) (23) (50)
Follicular Cell, Adenoma 2 (4%) 2 (7%) 2 (4%)
Follicular Cell, Carcinoma 1 (2%) 1 (4%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (1) (2)
Mediastinum, Hepatocellular Carcinoma,
Metastatic, Liver 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Seminal Vesicle (49) (32) (25) (48)
Histiocytic Sarcoma 1 (4%)
Testes (49) (32) (23) (49)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Interstitial Cell, Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (31) (22) (48)
Alveolar/Bronchiolar Carcinoma, Metastatic,
Lung 1 (2%)
Hemangiosarcoma 1 (2%) 2 (9%)
Mast Cell Tumor Malignant 1 (2%)
Lymph Node (49) (50) (49) (48)
Axillary, Sarcoma, Metastatic, Skin 1 (2%)
Inguinal, Sarcoma, Metastatic, Skin 1 (2%)
Mesenteric, Histiocytic Sarcoma 2 (4%) 2 (4%)
Pancreatic, Histiocytic Sarcoma 1 (2%)
Lymph Node, Mandibular (48) (27) (21) (48)
Fibrosarcoma, Metastatic, Skin 1 (2%)
Mast Cell Tumor Malignant 1 (2%)
Page 9
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Spleen (49) (31) (26) (47)
Hemangiosarcoma 1 (2%) 1 (3%) 1 (4%)
Histiocytic Sarcoma 2 (6%) 1 (4%)
Thymus (39) (18) (14) (32)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (49) (50) (48) (50)
Fibroma 4 (8%) 1 (2%) 2 (4%) 1 (2%)
Fibroma, Multiple 1 (2%)
Fibrosarcoma 3 (6%) 5 (10%) 5 (10%) 4 (8%)
Fibrosarcoma, Multiple 2 (4%) 1 (2%)
Hemangiosarcoma 1 (2%)
Sarcoma 5 (10%) 7 (14%) 5 (10%) 5 (10%)
Sarcoma, Multiple 1 (2%)
Schwannoma Malignant 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (32) (23) (49)
Third Ventricle, Lipoma 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (49) (49) (50) (50)
Alveolar/Bronchiolar Adenoma 3 (6%) 5 (10%) 6 (12%) 2 (4%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 2 (4%) 2 (4%) 4 (8%)
Alveolar/Bronchiolar Carcinoma, Multiple 1 (2%)
Fibrosarcoma, Metastatic, Skin 1 (2%) 1 (2%)
Hepatocellular Carcinoma, Metastatic, Liver 2 (4%) 1 (2%) 2 (4%) 3 (6%)
Histiocytic Sarcoma 2 (4%) 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Nose (49) (32) (23) (49)
____________________________________________________________________________________________________________________________________
Page 10
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Harderian Gland (2) (1) (1) (1)
Adenoma 2 (100%) 1 (100%) 1 (100%) 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (49) (33) (23) (50)
Hepatocellular Carcinoma, Metastatic, Liver 1 (2%)
Histiocytic Sarcoma 1 (3%) 1 (4%)
Bilateral, Alveolar/Bronchiolar Carcinoma,
Metastatic, Lung 1 (2%)
Cortex, Renal Tubule, Adenoma 1 (2%)
Renal Tubule, Adenoma 1 (3%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 3 (6%) 2 (4%)
Leukemia Granulocytic 1 (2%)
Lymphoma Malignant 1 (2%)
Lymphoma Malignant Mixed 2 (4%) 1 (2%) 3 (6%)
Lymphoma Malignant Undifferentiated Cell 2 (4%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 05021-04 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC CI PIGMENT RED 23 Date: 09/03/94
Route: DOSED FEED Time: 23:04:55
____________________________________________________________________________________________________________________________________
B6C3F1 MICE MALE UNTREATD 1.0% 2.5% 5.0%
CONTROL
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 35 27 33 41
Total Primary Neoplasms 54 37 48 63
Total Animals with Benign Neoplasms 17 13 12 20
Total Benign Neoplasms 18 13 14 26
Total Animals with Malignant Neoplasms 27 22 28 31
Total Malignant Neoplasms 36 24 34 37
Total Animals with Metastatic Neoplasms 5 3 3 4
Total Metastatic Neoplasm 9 3 4 5
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
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