TDMS Study 05043-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
2,4-DIAMINOPHENOL DIHYDROCHLORIDE
NTP Experiment-Test: 05043-01 Report: PEIRPT05
Study Type: CHRONIC Date: 09/05/94
Route: GAVAGE Time: 17:45:27
Facility: TSI Mason Research
Chemical CAS #: 137-09-7
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: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE .0125 G/ .025G/KG
72VF KG 72LF 72HF
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60
Scheduled Sacrifice 10 10 10
Early Deaths
Moribund 13 12 16
Dead 7 6 2
Accident 1
Survivors
Terminal Sacrifice 30 32 31
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (9) (14) (9)
Adenocarcinoma 1 (11%)
Intestine Large, Rectum (8) (11) (7)
Liver (50) (30) (50)
Mesentery (6) (5) (4)
Hemangiosarcoma 1 (17%)
Pancreas (49) (13) (50)
Acinus, Adenoma 1 (8%)
Stomach, Forestomach (50) (14) (50)
Stomach, Glandular (48) (13) (49)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (13) (49)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (15) (50)
Adenoma 1 (2%)
Medulla, Osteosarcoma, Metastatic, Uncertain
Primary Site 1 (2%)
Adrenal Gland, Medulla (47) (15) (48)
Pheochromocytoma Benign 2 (4%) 1 (7%) 3 (6%)
Islets, Pancreatic (49) (14) (50)
Adenoma 1 (7%)
Carcinoma 1 (7%)
Pituitary Gland (50) (50) (50)
Pars Distalis, Adenoma 22 (44%) 26 (52%) 25 (50%)
Page 2
NTP Experiment-Test: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE .0125 G/ .025G/KG
72VF KG 72LF 72HF
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pars Distalis, Carcinoma 2 (4%) 3 (6%)
Thyroid Gland (50) (12) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 7 (14%) 6 (12%)
C-Cell, Carcinoma 2 (4%) 1 (8%) 3 (6%)
Follicular Cell, Adenoma 2 (4%)
Follicular Cell, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (12) (17) (9)
Adenoma 1 (8%) 1 (6%) 1 (11%)
Adenoma, Moderate 1 (8%)
Carcinoma 1 (8%) 5 (29%) 1 (11%)
Ovary (49) (15) (49)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Uterus (50) (15) (50)
Polyp Stromal 12 (24%) 4 (27%) 9 (18%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (49) (49) (50)
Deep Cervical, Carcinoma, Metastatic,
Thyroid Gland 1 (2%)
Lymph Node, Mandibular (44) (10) (46)
Lymph Node, Mesenteric (49) (49) (50)
Spleen (50) (20) (50)
Osteosarcoma, Metastatic, Uncertain Primary
Site 1 (2%)
Thymus (7) (11) (8)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (27) (29) (19)
Carcinoma 3 (11%)
Fibroadenoma 12 (44%) 16 (55%) 11 (58%)
Fibroadenoma, Multiple 5 (19%) 5 (17%) 2 (11%)
Skin (12) (13) (9)
Page 3
NTP Experiment-Test: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE .0125 G/ .025G/KG
72VF KG 72LF 72HF
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - cont
Basal Cell Adenoma 1 (11%)
Sebaceous Gland, Adenoma 1 (11%)
Subcutaneous Tissue, Fibroma 1 (8%) 1 (8%)
Subcutaneous Tissue, Fibrosarcoma 3 (25%)
Subcutaneous Tissue, Sarcoma, Multiple 1 (8%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Abdominal, Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (11) (50)
Carcinoma, Metastatic 2 (4%)
Cerebrum, Carcinoma, Deep Invasion,
Metastatic, Pituitary Gland 1 (2%)
Pons, Glioma NOS 1 (9%)
Spinal Cord (1)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (17) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (6%)
Carcinoma, Metastatic, Thyroid Gland 1 (6%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50)
Urinary Bladder (49) (49) (50)
Papilloma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Leukemia Mononuclear 13 (26%) 7 (14%) 11 (22%)
* Number of animals with any tissue examined microscopically
Page 4
NTP Experiment-Test: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE .0125 G/ .025G/KG
72VF KG 72LF 72HF
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS - cont
Multiple Organs *(50) *(50) *(50)
Mesothelioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
Page 5
NTP Experiment-Test: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE VEHICLE .0125 G/ .025G/KG
72VF KG 72LF 72HF
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 40 41 47
Total Primary Neoplasms 91 74 83
Total Animals with Benign Neoplasms 32 38 39
Total Benign Neoplasms 65 58 62
Total Animals with Malignant Neoplasms 22 13 19
Total Malignant Neoplasms 26 15 21
Total Animals with Metastatic Neoplasms 3 1 2
Total Metastatic Neoplasm 5 1 2
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 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: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE .0125 G/ .025G/KG
72 VM KG 72LM 72HM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60
Scheduled Sacrifice 9 10 10
Early Deaths
Moribund 15 11 19
Dead 12 16 15
Accident 1
Gavage Death 1
Survivors
Dead 1
Terminal Sacrifice 23 20 16
Terminal Sacrifice 1
Animals Examined Microscopically 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (11) (19) (21)
Serosa, Sarcoma, Metastatic 1 (5%)
Intestine Small, Duodenum (47) (50) (50)
Liver (50) (31) (50)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Mesentery (7) (8) (4)
Pancreas (50) (22) (50)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Acinus, Adenoma 1 (2%) 3 (6%)
Acinus, Adenoma, Multiple 1 (5%)
Stomach, Forestomach (49) (23) (50)
Stomach, Glandular (49) (23) (50)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (22) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland (50) (50) (50)
Adrenal Gland, Cortex (50) (50) (50)
Adrenal Gland, Medulla (49) (50) (50)
Pheochromocytoma Malignant 7 (14%) 2 (4%) 3 (6%)
Page 7
NTP Experiment-Test: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE .0125 G/ .025G/KG
72 VM KG 72LM 72HM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Pheochromocytoma Benign 8 (16%) 7 (14%) 7 (14%)
Bilateral, Pheochromocytoma Benign 2 (4%) 1 (2%)
Islets, Pancreatic (50) (22) (50)
Adenoma 3 (6%) 3 (14%) 2 (4%)
Carcinoma 1 (2%)
Pituitary Gland (50) (50) (49)
Pars Distalis, Adenoma 23 (46%) 17 (34%) 14 (29%)
Pars Distalis, Carcinoma 1 (2%) 1 (2%)
Thyroid Gland (50) (20) (50)
Bilateral, C-Cell, Carcinoma 1 (2%)
C-Cell, Adenoma 4 (8%) 4 (20%) 2 (4%)
C-Cell, Adenoma, Mild 1 (2%)
C-Cell, Carcinoma 1 (2%) 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (20) (50)
Serosa, Sarcoma, Metastatic, Uncertain
Primary Site 1 (2%)
Preputial Gland (17) (24) (26)
Adenoma 1 (6%) 2 (8%) 2 (8%)
Carcinoma 2 (12%) 3 (13%) 2 (8%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (4%)
Prostate (49) (19) (50)
Adenoma 2 (4%) 1 (2%)
Seminal Vesicle (50) (25) (50)
Testes (50) (50) (50)
Bilateral, Interstitial Cell, Adenoma 25 (50%) 25 (50%) 35 (70%)
Interstitial Cell, Adenoma 17 (34%) 17 (34%) 11 (22%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (11) (20) (21)
Sarcoma, Metastatic, Uncertain Primary Site 1 (5%)
Lymph Node (50) (50) (50)
Lymph Node, Mandibular (49) (14) (47)
Lymph Node, Mesenteric (49) (49) (50)
Spleen (50) (29) (50)
Hemangiosarcoma 1 (3%)
Sarcoma 1 (2%) 2 (7%) 1 (2%)
Page 8
NTP Experiment-Test: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE .0125 G/ .025G/KG
72 VM KG 72LM 72HM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Sarcoma, Poorly Differentiated 1 (2%)
Thymus (17) (17) (24)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (9) (10) (12)
Fibroadenoma 4 (44%)
Skin (20) (26) (28)
Basal Cell Adenoma 1 (5%) 1 (4%) 1 (4%)
Keratoacanthoma 2 (10%) 3 (11%)
Keratoacanthoma, Multiple 1 (4%)
Squamous Cell Carcinoma 1 (5%) 1 (4%)
Squamous Cell Papilloma 1 (4%) 1 (4%)
Trichoepithelioma 1 (4%)
Sebaceous Gland, Carcinoma 1 (5%)
Subcutaneous Tissue, Fibroma 1 (5%) 1 (4%)
Subcutaneous Tissue, Fibrosarcoma 1 (5%) 1 (4%) 1 (4%)
Subcutaneous Tissue, Sarcoma 1 (5%)
Subcutaneous Tissue, Sarcoma, Metastatic,
Uncertain Primary Site 1 (4%)
Subcutaneous Tissue, Schwannoma Malignant 1 (4%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (2)
Abdominal, Sarcoma 1 (50%)
Hindlimb, Sarcoma, Metastatic, Uncertain
Primary Site 1 (50%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (50) (20) (50)
Astrocytoma Malignant 1 (2%)
Glioma NOS 1 (5%)
Granular Cell Tumor Benign 1 (2%)
Squamous Cell Carcinoma, Early Invasion,
Metastatic, Zymbal's Gland 1 (5%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE .0125 G/ .025G/KG
72 VM KG 72LM 72HM
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (30) (50)
Alveolar/Bronchiolar Adenoma 2 (4%) 3 (6%)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Gland 1 (3%)
Sarcoma, Metastatic, Uncertain Primary Site 1 (2%)
Nose (12) (21) (21)
Sarcoma, Metastatic, Uncertain Primary Site 1 (5%)
Nares, Squamous Cell Papilloma 1 (5%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1) (1) (2)
Carcinoma 1 (100%) 1 (100%) 1 (50%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (49) (50)
Sarcoma, Metastatic 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Renal Tubule, Carcinoma 1 (2%)
Transitional Epithelium, Carcinoma 1 (2%)
Urinary Bladder (50) (48) (50)
Transitional Epithelium, Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50)
Leukemia Mononuclear 7 (14%) 4 (8%) 5 (10%)
Mesothelioma Malignant 2 (4%) 3 (6%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05043-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 2,4-DIAMINOPHENOL DIHYDROCHLORIDE Date: 09/05/94
Route: GAVAGE Time: 17:45:27
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE VEHICLE .0125 G/ .025G/KG
72 VM KG 72LM 72HM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 46 49
Total Primary Neoplasms 126 100 112
Total Animals with Benign Neoplasms 47 45 48
Total Benign Neoplasms 96 81 91
Total Animals with Malignant Neoplasms 24 16 18
Total Malignant Neoplasms 30 18 21
Total Animals with Metastatic Neoplasms 2 2
Total Metastatic Neoplasm 2 13
Total Animals with Malignant Neoplasms 1
Uncertain Primary Site
Total Animals with Neoplasms Uncertain-
Benign or Malignant 1
Total Uncertain Neoplasms 1
____________________________________________________________________________________________________________________________________
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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