TDMS Study 05130-03 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
C. I. DIRECT BLUE 218
NTP Experiment-Test: 05130-03 Report: PEIRPT05
Study Type: CHRONIC Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
Facility: Microbiological Associates
Chemical CAS #: 10401-500
Lock Date: 11/21/91
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: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 9 9 10 10
Early Deaths
Moribund Sacrifice 12 15 13 16
Natural Death 4 7 6 9
Survivors
Moribund Sacrifice 1
Terminal Sacrifice 35 28 31 25
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (49) (50)
Lipoma 1 (2%)
Intestine Large, Colon (49) (47) (49) (48)
Intestine Large, Rectum (48) (47) (49) (48)
Intestine Large, Cecum (48) (47) (48) (48)
Intestine Small, Duodenum (48) (48) (50) (45)
Intestine Small, Jejunum (48) (45) (49) (47)
Carcinoma 1 (2%)
Intestine Small, Ileum (48) (46) (48) (46)
Liver (50) (50) (50) (50)
Sarcoma, Metastatic, Skin 1 (2%)
Mesentery (8) (6) (3) (6)
Sarcoma, Metastatic, Skin 1 (17%)
Schwannoma Malignant, Metastatic, Uterus 1 (17%)
Fat, Sarcoma 1 (33%)
Pancreas (50) (48) (50) (48)
Pharynx (1) (1) (2)
Palate, Squamous Cell Papilloma 1 (100%) 1 (100%) 2 (100%)
Salivary Glands (50) (50) (50) (50)
Stomach, Forestomach (50) (49) (50) (49)
Squamous Cell Papilloma 1 (2%)
Stomach, Glandular (50) (48) (50) (48)
Sarcoma, Metastatic, Skin 1 (2%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Schwannoma NOS 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (50) (50) (50) (49)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Adrenal Medulla (49) (50) (47) (49)
Pheochromocytoma Benign 1 (2%) 2 (4%)
Bilateral, Pheochromocytoma Benign 1 (2%) 1 (2%)
Islets, Pancreatic (50) (48) (50) (48)
Adenoma 1 (2%) 2 (4%)
Parathyroid Gland (45) (43) (39) (44)
Pituitary Gland (50) (47) (49) (47)
Pars Distalis, Adenoma 26 (52%) 29 (62%) 30 (61%) 20 (43%)
Pars Distalis, Adenoma, Multiple 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Pars Distalis, Carcinoma 2 (4%) 1 (2%) 2 (4%)
Pars Intermedia, Adenoma 1 (2%)
Thyroid Gland (50) (50) (49) (49)
Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%)
C-Cell, Adenoma 2 (4%) 4 (8%) 2 (4%) 2 (4%)
C-Cell, Carcinoma 1 (2%) 3 (6%)
Follicular Cell, Adenoma 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1)
Schwannoma Malignant, Metastatic, Uterus 1 (100%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (47) (48) (49) (47)
Adenoma 2 (4%) 2 (4%) 2 (4%)
Carcinoma 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Ovary (50) (50) (50) (50)
Granulosa Cell Tumor Benign 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Uterus (50) (50) (50) (50)
Adenoma 1 (2%) 1 (2%)
Leiomyosarcoma 1 (2%)
Polyp Stromal 1 (2%) 12 (24%) 10 (20%) 10 (20%)
Sarcoma 1 (2%)
Page 3
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Schwannoma Malignant 1 (2%)
Cervix, Schwannoma Malignant, Metastatic,
Uterus 1 (2%)
Vagina (1) (1) (2) (3)
Fibroma 1 (33%)
Leiomyosarcoma 1 (100%)
Schwannoma Malignant, Metastatic, Uterus 1 (100%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (49) (49) (50) (49)
Lymph Node (7) (12) (6) (14)
Lymph Node, Mandibular (49) (50) (50) (50)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Lymph Node, Mesenteric (50) (50) (50) (50)
Sarcoma, Metastatic, Skin 1 (2%)
Schwannoma Malignant, Metastatic, Uterus 1 (2%)
Spleen (50) (49) (50) (48)
Thymus (48) (49) (42) (45)
Thymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50) (50) (50) (50)
Adenoacanthoma 1 (2%)
Adenocarcinoma 3 (6%) 1 (2%) 2 (4%) 1 (2%)
Adenoma 1 (2%)
Fibroadenoma 14 (28%) 11 (22%) 16 (32%) 10 (20%)
Fibroadenoma, Multiple 5 (10%) 1 (2%) 3 (6%)
Sarcoma, Metastatic, Skin 1 (2%)
Skin (50) (50) (50) (50)
Keratoacanthoma 1 (2%)
Subcutaneous Tissue, Fibroma 1 (2%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1) (1)
Back, Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Astrocytoma NOS 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%)
Ependymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 2 (4%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%) 2 (4%)
Fibrosarcoma, Metastatic, Ear 1 (2%)
Sarcoma, Metastatic, Skin 1 (2%)
Nose (50) (50) (50) (50)
Trachea (50) (50) (49) (50)
Carcinoma, Metastatic, Thyroid Gland 2 (4%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Pinna, Fibrosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Carcinoma 1 (2%)
Lipoma 1 (2%)
Urinary Bladder (48) (48) (50) (49)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 11 (22%) 16 (32%) 9 (18%) 16 (32%)
Lymphoma Malignant Lymphocytic 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 45 46 46 45
Total Primary Neoplasms 74 92 89 84
Total Animals with Benign Neoplasms 37 39 39 38
Total Benign Neoplasms 56 68 71 58
Total Animals with Malignant Neoplasms 17 22 17 22
Total Malignant Neoplasms 18 23 17 26
Total Animals with Metastatic Neoplasms 2 2 1 3
Total Metastatic Neoplasm 2 12 1 7
Total Animals with Malignant Neoplasms
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1 1
Total Uncertain Neoplasms 1 1
____________________________________________________________________________________________________________________________________
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: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 9
Early Deaths
Natural Death 7 3 5 9
Moribund Sacrifice 13 22 16 18
Survivors
Terminal Sacrifice 30 25 29 24
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Esophagus (50) (50) (50) (50)
Intestine Large, Colon (50) (50) (50) (50)
Leiomyoma 1 (2%)
Sarcoma, Metastatic, Spleen 1 (2%)
Intestine Large, Rectum (46) (49) (49) (50)
Intestine Large, Cecum (46) (49) (49) (49)
Adenocarcinoma 1 (2%)
Intestine Small, Duodenum (49) (49) (50) (48)
Sarcoma, Metastatic, Spleen 1 (2%)
Intestine Small, Jejunum (47) (49) (49) (46)
Intestine Small, Ileum (46) (49) (48) (47)
Liver (50) (50) (50) (50)
Hepatocellular Adenoma 4 (8%) 5 (10%) 1 (2%) 6 (12%)
Hepatocellular Adenoma, Multiple 1 (2%) 1 (2%) 1 (2%)
Histiocytic Sarcoma 2 (4%)
Sarcoma, Metastatic, Spleen 1 (2%)
Mesentery (5) (5) (7) (4)
Sarcoma, Metastatic, Spleen 1 (14%)
Pancreas (50) (50) (50) (50)
Sarcoma, Metastatic, Spleen 1 (2%)
Pharynx (1) (9)
Palate, Basosquamous Tumor Benign 1 (11%)
Palate, Squamous Cell Carcinoma 1 (11%)
Palate, Squamous Cell Papilloma 5 (56%)
Salivary Glands (50) (50) (50) (50)
Carcinoma 1 (2%)
Stomach, Forestomach (50) (50) (50) (50)
Sarcoma, Metastatic, Spleen 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 2 (4%) 1 (2%)
Stomach, Glandular (50) (50) (50) (50)
Page 7
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - cont
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Schwannoma Malignant 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (49) (50) (50) (50)
Adenoma 1 (2%)
Sarcoma, Metastatic, Spleen 1 (2%)
Adrenal Medulla (49) (50) (50) (50)
Mixed Tumor Malignant 1 (2%)
Pheochromocytoma Malignant 2 (4%) 2 (4%) 1 (2%)
Pheochromocytoma Benign 14 (29%) 7 (14%) 9 (18%) 7 (14%)
Sarcoma, Metastatic, Spleen 1 (2%)
Bilateral, Pheochromocytoma Benign 1 (2%) 2 (4%) 3 (6%) 5 (10%)
Islets, Pancreatic (50) (50) (50) (50)
Adenoma 4 (8%) 5 (10%) 3 (6%) 7 (14%)
Carcinoma 1 (2%)
Parathyroid Gland (43) (47) (46) (45)
Adenoma 1 (2%) 1 (2%)
Pituitary Gland (50) (50) (48) (50)
Pars Distalis, Adenoma 15 (30%) 14 (28%) 15 (31%) 9 (18%)
Pars Distalis, Adenoma, Multiple 1 (2%) 3 (6%)
Pars Distalis, Carcinoma 2 (4%)
Thyroid Gland (50) (50) (50) (50)
C-Cell, Adenoma 7 (14%) 1 (2%) 4 (8%) 4 (8%)
C-Cell, Carcinoma 1 (2%) 1 (2%) 1 (2%)
Follicular Cell, Carcinoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Preputial Gland (50) (50) (50) (49)
Adenoma 1 (2%) 3 (6%) 2 (4%) 2 (4%)
Squamous Cell Papilloma 1 (2%)
Bilateral, Adenoma 1 (2%)
Prostate (50) (50) (50) (49)
Page 8
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Seminal Vesicle (50) (50) (50) (49)
Testes (50) (50) (50) (50)
Sarcoma, Metastatic, Spleen 1 (2%)
Bilateral, Interstitial Cell, Adenoma 41 (82%) 41 (82%) 43 (86%) 33 (66%)
Interstitial Cell, Adenoma 4 (8%) 5 (10%) 5 (10%) 11 (22%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (1)
Bone Marrow (50) (50) (50) (50)
Histiocytic Sarcoma 2 (4%)
Lymph Node (15) (16) (23) (18)
Pancreatic, Rhabdomyosarcoma, Metastatic,
Skeletal Muscle 1 (7%)
Lymph Node, Mandibular (48) (50) (49) (50)
Lymph Node, Mesenteric (49) (50) (50) (50)
Rhabdomyosarcoma, Metastatic, Skeletal Muscle 1 (2%)
Sarcoma, Metastatic, Spleen 1 (2%)
Spleen (50) (50) (50) (49)
Sarcoma 1 (2%) 1 (2%)
Thymus (48) (40) (49) (48)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (48) (49) (50) (46)
Adenocarcinoma 1 (2%)
Fibroadenoma 2 (4%) 2 (4%) 1 (2%) 1 (2%)
Fibroadenoma, Multiple 1 (2%)
Histiocytic Sarcoma 1 (2%)
Skin (50) (50) (50) (50)
Basal Cell Adenoma 2 (4%) 2 (4%)
Basal Cell Carcinoma 1 (2%)
Basosquamous Tumor Benign 1 (2%)
Keratoacanthoma 1 (2%) 2 (4%) 2 (4%) 3 (6%)
Keratoacanthoma, Multiple 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%)
Sebaceous Gland, Adenoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibroma 4 (8%) 4 (8%) 5 (10%) 2 (4%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Histiocytic Sarcoma 1 (2%)
Subcutaneous Tissue, Neurofibrosarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2) (1) (1)
Histiocytic Sarcoma 1 (100%)
Lipoma 1 (100%)
Abdominal, Rhabdomyosarcoma 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (50) (50) (50)
Ependymoma Benign 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 2 (4%) 1 (2%) 2 (4%)
Histiocytic Sarcoma 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Medulla 1 (2%)
Sarcoma, Metastatic, Spleen 1 (2%)
Nose (50) (50) (49) (50)
Trachea (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (48) (48) (48) (48)
Carcinoma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Squamous Cell Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Renal Tubule, Adenoma 2 (4%)
Transitional Epithelium, Carcinoma 1 (2%) 1 (2%)
Urinary Bladder (50) (50) (50) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 2 (4%)
Leukemia Mononuclear 18 (36%) 25 (50%) 23 (46%) 26 (52%)
Mesothelioma Malignant 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05130-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC C. I. DIRECT BLUE 218 Date: 09/17/94
Route: DOSED FEED Time: 01:29:35
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE 0 PPM 1000 PPM 3000 PPM 10000PPM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 50 49 49
Total Primary Neoplasms 136 129 137 143
Total Animals with Benign Neoplasms 47 50 49 46
Total Benign Neoplasms 107 100 102 106
Total Animals with Malignant Neoplasms 27 27 28 31
Total Malignant Neoplasms 29 29 35 37
Total Animals with Metastatic Neoplasms 1 2
Total Metastatic Neoplasm 2 12
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
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