TDMS Study 05035-03 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
4-HYDROXYACETANILIDE
NTP Experiment-Test: 05035-03 Report: PEIRPT05
Study Type: CHRONIC Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
Facility: TSI Mason Research
Chemical CAS #: 103-90-2
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: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Dead 6 4 3
Moribund 14 12 13 22
Survivors
Terminal Sacrifice 28 34 34 27
Dead 1
Moribund 1 1
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (47) (48) (50) (50)
Intestine Large, Colon (48) (49) (49) (49)
Intestine Small, Duodenum (48) (50) (50) (50)
Intestine Small, Ileum (43) (46) (48) (50)
Liver (50) (50) (50) (50)
Mesentery (6) (3) (6) (8)
Sarcoma 1 (17%)
Pancreas (47) (49) (49) (48)
Pharynx (1)
Palate, Squamous Cell Papilloma 1 (100%)
Salivary Glands (49) (50) (50) (50)
Stomach, Forestomach (50) (50) (50) (49)
Stomach, Glandular (49) (50) (50) (50)
Tooth (1) (1) (1)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (49) (50) (50) (50)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50) (49)
Adenoma 1 (2%)
Adrenal Gland, Medulla (39) (47) (44) (47)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Benign 3 (8%) 6 (13%) 6 (14%) 4 (9%)
Islets, Pancreatic (46) (49) (48) (47)
Page 2
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - cont
Adenoma 1 (2%) 2 (4%) 1 (2%) 1 (2%)
Pituitary Gland (47) (50) (50) (49)
Pars Distalis, Adenoma 23 (49%) 31 (62%) 27 (54%) 24 (49%)
Pars Distalis, Carcinoma 1 (2%) 2 (4%) 1 (2%)
Thyroid Gland (49) (50) (50) (50)
Bilateral, C-Cell, Adenoma 1 (2%)
C-Cell, Adenoma 9 (18%) 4 (8%) 6 (12%) 7 (14%)
C-Cell, Carcinoma 1 (2%) 3 (6%) 3 (6%) 1 (2%)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 2 (4%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (2) (1)
Sarcoma 1 (50%) 1 (100%)
Squamous Cell Carcinoma 1 (50%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (43) (47) (43) (40)
Adenoma 3 (7%) 1 (2%) 6 (14%) 5 (13%)
Carcinoma 4 (9%) 5 (11%) 3 (7%) 2 (5%)
Squamous Cell Papilloma 1 (2%)
Bilateral, Adenoma 2 (5%)
Ovary (49) (50) (50) (49)
Granulosa Cell Tumor Benign 1 (2%)
Luteoma 1 (2%)
Uterus (49) (50) (50) (50)
Leiomyoma 1 (2%)
Leiomyosarcoma 1 (2%) 1 (2%)
Polyp Stromal 15 (31%) 12 (24%) 14 (28%) 10 (20%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (31) (6) (4) (29)
Bone Marrow (49) (49) (49) (50)
Lymph Node (50) (49) (50) (50)
Lymph Node, Mandibular (43) (46) (45) (44)
Lymph Node, Mesenteric (48) (48) (49) (50)
Spleen (50) (50) (50) (50)
Sarcoma 1 (2%)
Thymus (39) (42) (36) (42)
Thymoma Benign 1 (3%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (46) (47) (48) (43)
Adenocarcinoma 1 (2%) 1 (2%) 2 (5%)
Fibroadenoma 19 (41%) 23 (49%) 20 (42%) 18 (42%)
Fibroadenoma, Multiple 1 (2%)
Skin (50) (46) (48) (48)
Basal Cell Adenoma 1 (2%)
Basal Cell Carcinoma 1 (2%)
Squamous Cell Papilloma 1 (2%) 1 (2%) 1 (2%)
Subcutaneous Tissue, Fibroma 2 (4%) 2 (4%)
Subcutaneous Tissue, Fibrosarcoma 2 (4%) 2 (4%)
Subcutaneous Tissue, Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (50) (50) (50)
Astrocytoma Malignant 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Carcinoma Adenosquamous 1 (2%)
Nose (47) (50) (50) (50)
Adenoma 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Zymbal's Gland (1) (1)
Carcinoma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Sarcoma 1 (2%)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (44) (45) (49) (50)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Leukemia Mononuclear 9 (18%) 17 (34%) 15 (30%) 24 (48%)
Lymphoma Malignant Lymphocytic 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.06% LF 0.3% MF 0.6% HF
UF
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 47 46 49 46
Total Primary Neoplasms 108 117 106 111
Total Animals with Benign Neoplasms 41 44 45 40
Total Benign Neoplasms 83 88 81 73
Total Animals with Malignant Neoplasms 21 23 21 33
Total Malignant Neoplasms 25 29 25 38
Total Animals with Metastatic Neoplasms 1 1 2
Total Metastatic Neoplasm 1 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: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 60 60 60 60
Scheduled Sacrifice 10 10 10 10
Early Deaths
Moribund 22 20 25 22
Dead 1 2 2 4
Survivors
Terminal Sacrifice 27 28 23 24
Animals Examined Microscopically 50 50 50 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (48) (49) (49) (48)
Intestine Large, Colon (48) (49) (50) (50)
Intestine Large, Rectum (50) (47) (47) (49)
Intestine Small, Duodenum (50) (50) (50) (50)
Intestine Small, Ileum (49) (48) (48) (46)
Intestine Small, Jejunum (50) (48) (49) (49)
Liver (50) (50) (50) (50)
Hepatocellular Adenoma 1 (2%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Mesentery (3) (9) (3) (2)
Liposarcoma 1 (33%)
Pancreas (49) (49) (47) (47)
Acinus, Adenoma 1 (2%)
Acinus, Carcinoma 1 (2%)
Pharynx (1)
Palate, Squamous Cell Papilloma 1 (100%)
Salivary Glands (50) (50) (50) (50)
Stomach, Forestomach (49) (50) (46) (50)
Stomach, Glandular (50) (50) (50) (50)
Tongue (1)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (50) (50) (50) (50)
Schwannoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
Page 7
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (50) (50) (50) (50)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Adrenal Gland, Medulla (44) (49) (49) (46)
Ganglioneuroma 1 (2%)
Pheochromocytoma Malignant 1 (2%) 2 (4%) 2 (4%) 2 (4%)
Pheochromocytoma Benign 11 (25%) 17 (35%) 13 (27%) 16 (35%)
Bilateral, Pheochromocytoma Benign 5 (11%) 3 (6%) 4 (8%) 3 (7%)
Islets, Pancreatic (49) (49) (46) (48)
Adenoma 2 (4%) 4 (8%) 2 (4%) 1 (2%)
Carcinoma 1 (2%) 1 (2%)
Pituitary Gland (48) (49) (49) (48)
Pars Distalis, Adenoma 16 (33%) 27 (55%) 19 (39%) 19 (40%)
Pars Distalis, Carcinoma 1 (2%) 1 (2%)
Thyroid Gland (50) (50) (50) (50)
Bilateral, C-Cell, Carcinoma 1 (2%)
C-Cell, Adenoma 4 (8%) 8 (16%) 1 (2%) 6 (12%)
C-Cell, Carcinoma 3 (6%) 3 (6%) 1 (2%) 2 (4%)
Follicular Cell, Adenoma 1 (2%)
Follicular Cell, Carcinoma 1 (2%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (50) (50) (50) (50)
Preputial Gland (48) (50) (49) (47)
Adenoma 2 (4%) 6 (12%) 2 (4%) 5 (11%)
Carcinoma 3 (6%) 6 (12%) 3 (6%) 5 (11%)
Prostate (47) (49) (50) (49)
Seminal Vesicle (48) (49) (50) (50)
Testes (50) (50) (50) (50)
Liposarcoma, Metastatic 1 (2%)
Bilateral, Interstitial Cell, Adenoma 29 (58%) 36 (72%) 35 (70%) 33 (66%)
Bilateral, Interstitial Cell, Carcinoma 1 (2%)
Interstitial Cell, Adenoma 13 (26%) 9 (18%) 13 (26%) 10 (20%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Blood (25) (8) (10) (23)
Bone Marrow (50) (50) (50) (49)
Histiocytic Sarcoma 1 (2%)
Lymph Node (50) (50) (50) (49)
Carcinoma, Metastatic, Thyroid Gland 1 (2%)
Mediastinal, Histiocytic Sarcoma 1 (2%)
Lymph Node, Mandibular (47) (45) (49) (45)
Histiocytic Sarcoma 1 (2%)
Lymph Node, Mesenteric (49) (50) (50) (48)
Spleen (50) (50) (50) (50)
Hemangiosarcoma 2 (4%) 1 (2%)
Histiocytic Sarcoma 1 (2%)
Sarcoma 1 (2%)
Thymus (40) (37) (40) (42)
Histiocytic Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (36) (34) (35) (36)
Fibroadenoma 4 (11%) 5 (15%) 1 (3%) 1 (3%)
Skin (50) (50) (48) (49)
Basal Cell Adenoma 1 (2%) 1 (2%)
Basal Cell Carcinoma 1 (2%)
Keratoacanthoma 3 (6%) 2 (4%) 2 (4%) 1 (2%)
Squamous Cell Carcinoma 1 (2%) 1 (2%)
Squamous Cell Papilloma 2 (4%) 1 (2%)
Subcutaneous Tissue, Fibroma 6 (12%) 4 (8%) 2 (4%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%) 1 (2%)
Subcutaneous Tissue, Hemangiosarcoma 1 (2%)
Subcutaneous Tissue, Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (49) (50) (50) (50)
Osteoma 1 (2%)
Skeletal Muscle (1) (1)
Hemangiosarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (49) (50) (50) (49)
Astrocytoma Malignant 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%) 1 (2%)
Glioma Malignant 1 (2%)
Granular Cell Tumor NOS 1 (2%)
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50) (50) (50) (50)
Alveolar/Bronchiolar Adenoma 2 (4%) 2 (4%) 2 (4%) 3 (6%)
Alveolar/Bronchiolar Carcinoma 1 (2%) 1 (2%)
Carcinoma, Metastatic, Adrenal Gland 1 (2%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%)
Hemangiosarcoma, Metastatic, Spleen 1 (2%)
Histiocytic Sarcoma 1 (2%)
Pheochromocytoma Malignant, Metastatic 1 (2%)
Pheochromocytoma Malignant, Metastatic,
Adrenal Gland 1 (2%)
Nose (49) (50) (50) (49)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (3) (2) (3)
Squamous Cell Papilloma 1 (33%)
Eye (3) (5) (11) (8)
Carcinoma, Metastatic, Harderian Gland 1 (20%)
Harderian Gland (4) (5) (9) (6)
Carcinoma 1 (20%)
Zymbal's Gland (4) (2)
Carcinoma 4 (100%) 2 (100%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (50) (50) (50) (50)
Hamartoma 1 (2%)
Lipoma 1 (2%)
Renal Tubule, Adenoma 3 (6%) 3 (6%) 3 (6%)
Urinary Bladder (49) (48) (47) (46)
Page 10
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(50) *(50) *(50) *(50)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 27 (54%) 26 (52%) 24 (48%) 20 (40%)
Mesothelioma Benign 1 (2%)
Mesothelioma Malignant 2 (4%) 5 (10%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 11
NTP Experiment-Test: 05035-03 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 4-HYDROXYACETANILIDE Date: 09/05/94
Route: DOSED FEED Time: 00:14:46
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.06% LM 0.3% MM 0.6% HM
UM
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 49 50 50 50
Total Primary Neoplasms 145 178 141 152
Total Animals with Benign Neoplasms 47 50 50 49
Total Benign Neoplasms 103 128 102 109
Total Animals with Malignant Neoplasms 34 34 34 35
Total Malignant Neoplasms 42 50 39 42
Total Animals with Metastatic Neoplasms 3 3 3 2
Total Metastatic Neoplasm 3 4 3 2
Total Animals with Malignant Neoplasms
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 12
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