TDMS Study 96007-05 Pathology Tables
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
FINAL #3/RATS
Facility: Battelle Columbus Laboratory
Chemical CAS #: 57117-31-4
Lock Date: 07/25/02
Cage Range: All
Reasons For Removal: 25018 Dosing Accident 25019 Moribund Sacrifice
25020 Natural Death 25021 Terminal Sacrifice
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: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 98 98 98 98 98 98
Early Deaths
Natural Death 7 10 10 8 14 11
Moribund Sacrifice 21 20 17 19 19 19
Dosing Accident 1 2 1
Survivors
Terminal Sacrifice 25 22 24 25 20 23
Animals Examined Microscopically 53 53 53 53 53 53
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ALIMENTARY SYSTEM
Intestine Large, Colon (53) (53) (53) (53) (51) (53)
Carcinoma, Metastatic, Uterus 1 (2%)
Intestine Large, Rectum (53) (53) (53) (53) (52) (53)
Carcinoma, Metastatic, Uterus 1 (2%)
Intestine Large, Cecum (53) (53) (53) (52) (51) (53)
Intestine Small, Duodenum (53) (53) (53) (53) (52) (53)
Carcinoma, Metastatic, Uterus 1 (2%)
Intestine Small, Jejunum (53) (53) (53) (52) (52) (53)
Leiomyoma 1 (2%)
Liver (53) (53) (53) (52) (53) (53)
Carcinoma, Metastatic, Uterus 1 (2%) 1 (2%)
Cholangiocarcinoma 1 (2%) 1 (2%) 1 (2%)
Cholangiocarcinoma, Multiple 1 (2%)
Hepatocellular Adenoma 1 (2%) 1 (2%) 2 (4%) 4 (8%)
Oral Mucosa (52) (53) (52) (53) (53) (53)
Gingival, Squamous Cell Carcinoma 1 (2%) 2 (4%) 1 (2%) 1 (2%) 3 (6%)
Pancreas (53) (53) (53) (52) (52) (52)
Carcinoma, Metastatic, Uterus 1 (2%) 1 (2%)
Acinus, Adenoma 1 (2%)
Acinus, Carcinoma 1 (2%)
Stomach, Forestomach (53) (53) (53) (53) (52) (53)
Fibrosarcoma 1 (2%)
Stomach, Glandular (53) (53) (53) (53) (52) (53)
Carcinoma, Metastatic, Uterus 1 (2%)
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Page 2
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (53) (53) (52) (53) (53) (52)
Schwannoma Malignant 1 (2%) 2 (4%) 2 (4%)
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ENDOCRINE SYSTEM
Adrenal Cortex (53) (53) (53) (52) (53) (53)
Adenoma 1 (2%) 1 (2%) 2 (4%)
Carcinoma 1 (2%) 1 (2%)
Adrenal Medulla (53) (53) (53) (52) (53) (53)
Pheochromocytoma Malignant 1 (2%)
Pheochromocytoma Complex 1 (2%)
Pheochromocytoma Benign 4 (8%) 5 (9%) 2 (4%) 5 (10%) 1 (2%) 2 (4%)
Bilateral, Pheochromocytoma Benign 1 (2%)
Islets, Pancreatic (53) (53) (53) (52) (52) (52)
Adenoma 1 (2%) 1 (2%) 1 (2%) 2 (4%)
Carcinoma 1 (2%)
Parathyroid Gland (49) (51) (44) (51) (49) (49)
Adenoma 2 (4%)
Pituitary Gland (53) (53) (53) (53) (53) (53)
Carcinoma 1 (2%)
Pars Distalis, Adenoma 15 (28%) 21 (40%) 23 (43%) 23 (43%) 21 (40%) 16 (30%)
Thyroid Gland (53) (53) (51) (53) (51) (51)
Bilateral, C-Cell, Adenoma 1 (2%) 1 (2%) 1 (2%)
C-Cell, Adenoma 13 (25%) 9 (17%) 8 (16%) 8 (15%) 6 (12%) 7 (14%)
C-Cell, Carcinoma 2 (4%) 2 (4%) 2 (4%) 2 (4%) 1 (2%)
Follicular Cell, Adenoma 1 (2%)
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GENERAL BODY SYSTEM
None
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GENITAL SYSTEM
Clitoral Gland (53) (51) (53) (53) (50) (53)
Adenoma 1 (2%)
Carcinoma, Metastatic, Mammary Gland 1 (2%)
Ovary (53) (53) (53) (52) (52) (53)
Cystadenoma 1 (2%)
Granulosa Cell Tumor Malignant 1 (2%)
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NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM - cont
Granulosa Cell Tumor Benign 1 (2%) 1 (2%)
Luteoma 1 (2%)
Sertoli Cell Tumor Malignant 1 (2%)
Uterus (53) (53) (53) (52) (52) (53)
Adenoma 2 (4%)
Carcinoma 1 (2%) 1 (2%) 1 (2%) 5 (10%) 2 (4%)
Fibroma 1 (2%)
Leiomyoma 1 (2%)
Polyp Stromal 8 (15%) 3 (6%) 5 (9%) 5 (10%) 6 (12%) 3 (6%)
Polyp Stromal, Multiple 1 (2%) 1 (2%) 1 (2%)
Schwannoma Malignant 1 (2%) 1 (2%)
Squamous Cell Carcinoma 1 (2%)
Cervix, Polyp Stromal 1 (2%)
Cervix, Sarcoma Stromal 1 (2%)
Cervix, Schwannoma Malignant 1 (2%)
Cervix, Squamous Cell Carcinoma 1 (2%)
Vagina (1) (1) (1)
Polyp 1 (100%)
Sarcoma Stromal 1 (100%)
Squamous Cell Papilloma 1 (100%)
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HEMATOPOIETIC SYSTEM
Bone Marrow (53) (53) (53) (53) (53) (53)
Lymph Node (5) (4) (4) (4) (3) (7)
Deep Cervical, Carcinoma, Metastatic,
Thyroid Gland 1 (25%)
Inguinal, Carcinoma, Metastatic, Mammary
Gland 1 (14%)
Mediastinal, Carcinoma, Metastatic, Thyroid
Gland 1 (25%)
Lymph Node, Mandibular (53) (53) (51) (53) (51) (51)
Lymph Node, Mesenteric (53) (53) (53) (52) (52) (53)
Carcinoma, Metastatic, Uterus 1 (2%)
Spleen (53) (53) (53) (52) (52) (51)
Carcinoma, Metastatic, Uterus 1 (2%)
Thymus (53) (49) (50) (52) (49) (51)
Osteosarcoma, Metastatic, Skin 1 (2%)
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Page 4
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (53) (53) (53) (53) (53) (53)
Adenoma 1 (2%) 1 (2%) 2 (4%) 1 (2%)
Carcinoma 5 (9%) 9 (17%) 11 (21%) 2 (4%) 5 (9%) 3 (6%)
Carcinoma, Multiple 3 (6%) 2 (4%)
Fibroadenoma 24 (45%) 23 (43%) 23 (43%) 21 (40%) 22 (42%) 17 (32%)
Fibroadenoma, Multiple 10 (19%) 12 (23%) 7 (13%) 8 (15%) 12 (23%) 13 (25%)
Osteosarcoma, Metastatic, Skin 1 (2%)
Skin (53) (53) (53) (53) (53) (53)
Basal Cell Carcinoma 1 (2%)
Fibroma 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Fibrosarcoma 1 (2%)
Fibrous Histiocytoma 1 (2%)
Keratoacanthoma 1 (2%)
Neural Crest Tumor 1 (2%)
Neurofibroma 1 (2%)
Osteosarcoma 1 (2%)
Schwannoma Malignant 1 (2%)
Subcutaneous Tissue, Hemangioma 1 (2%)
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MUSCULOSKELETAL SYSTEM
Bone (53) (53) (53) (53) (53) (53)
Osteosarcoma 1 (2%)
Skeletal Muscle (2)
Rhabdomyosarcoma 1 (50%)
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NERVOUS SYSTEM
Brain (53) (53) (53) (53) (53) (53)
Astrocytoma Malignant 1 (2%) 1 (2%) 1 (2%)
Carcinoma, Metastatic, Pituitary Gland 1 (2%)
Granular Cell Tumor Malignant 1 (2%)
Cranial Nerve, Squamous Cell Carcinoma,
Metastatic, Oral Mucosa 1 (2%)
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NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (53) (53) (53) (53) (53) (52)
Alveolar/Bronchiolar Adenoma 1 (2%)
Carcinoma, Metastatic, Mammary Gland 1 (2%) 1 (2%) 2 (4%)
Carcinoma, Metastatic, Thyroid Gland 1 (2%) 1 (2%)
Carcinoma, Metastatic, Uterus 1 (2%) 1 (2%)
Cystic Keratinizing Epithelioma, Multiple 1 (2%)
Fibrous Histiocytoma, Metastatic, Skin 1 (2%)
Histiocytic Sarcoma 1 (2%)
Osteosarcoma, Metastatic, Skin 1 (2%)
Nose (53) (53) (53) (53) (53) (53)
Sarcoma 1 (2%)
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SPECIAL SENSES SYSTEM
Eye (53) (53) (52) (53) (52) (52)
Sarcoma 1 (2%)
Harderian Gland (53) (53) (53) (53) (52) (52)
Carcinoma, Metastatic, Oral Mucosa 1 (2%)
Zymbal's Gland (1)
Adenoma 1 (100%)
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URINARY SYSTEM
Kidney (53) (53) (53) (52) (53) (53)
Lipoma 1 (2%)
Nephroblastoma 1 (2%) 1 (2%)
Renal Tubule, Adenoma 1 (2%) 1 (2%)
Urinary Bladder (53) (52) (53) (53) (51) (53)
Carcinoma, Metastatic, Uterus 1 (2%)
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SYSTEMIC LESIONS
Multiple Organs *(53) *(53) *(53) *(53) *(53) *(53)
Histiocytic Sarcoma 1 (2%)
Leukemia Mononuclear 1 (2%) 1 (2%) 1 (2%)
Lymphoma Malignant 1 (2%)
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* Number of animals with any tissue examined microscopically
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NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200
NG/KG
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 48 49 49 44 48 46
Total Primary Neoplasms 97 110 102 89 96 90
Total Animals with Benign Neoplasms 45 45 43 42 45 41
Total Benign Neoplasms 84 83 79 76 78 70
Total Animals with Malignant Neoplasms 12 20 21 13 16 16
Total Malignant Neoplasms 13 27 23 13 18 19
Total Animals with Metastatic Neoplasms 2 3 1 1 3 5
Total Metastatic Neoplasm 2 3 3 1 7 14
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
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NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 50
Early Deaths
Moribund Sacrifice 25
Natural Death 10
Survivors
Terminal Sacrifice 15
Animals Examined Microscopically 50
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (50)
Squamous Cell Carcinoma, Metastatic, Uterus 1 (2%)
Liver (50)
Hepatocellular Adenoma 1 (2%)
Oral Mucosa (50)
Gingival, Squamous Cell Carcinoma 3 (6%)
Pancreas (49)
Adenoma 1 (2%)
Carcinoma 1 (2%)
Stomach, Forestomach (50)
Squamous Cell Papilloma 1 (2%)
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CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (48)
Adenoma 1 (2%)
Adrenal Medulla (48)
Pheochromocytoma Benign 1 (2%)
Pituitary Gland (49)
Pars Distalis, Adenoma 13 (27%)
Thyroid Gland (48)
C-Cell, Adenoma 5 (10%)
____________________________________________________________________________________________________________________________________
Page 8
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (47)
Luteoma 1 (2%)
Uterus (49)
Carcinoma 1 (2%)
Hemangioma 1 (2%)
Polyp Stromal 4 (8%)
Cervix, Squamous Cell Carcinoma 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Thymus (49)
Thymoma Malignant, Metastatic, Mammary Gland 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (50)
Adenoma 2 (4%)
Carcinoma 5 (10%)
Fibroadenoma 25 (50%)
Fibroadenoma, Multiple 9 (18%)
Skin (50)
Basal Cell Carcinoma 1 (2%)
Fibroma 1 (2%)
Fibrosarcoma 1 (2%)
Sarcoma 1 (2%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (50)
Fibrosarcoma, Metastatic, Skin 1 (2%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (50)
Squamous Cell Carcinoma, Metastatic, Uterus 1 (2%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
None
Page 10
NTP Experiment-Test: 96007-05 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) Date: 09/30/03
Route: GAVAGE Time: 11:23:01
____________________________________________________________________________________________________________________________________
SPRAGUE-DAWLEY RATS FEMALE 200 NG/
KG STOP
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 43
Total Primary Neoplasms 80
Total Animals with Benign Neoplasms 40
Total Benign Neoplasms 66
Total Animals with Malignant Neoplasms 12
Total Malignant Neoplasms 14
Total Animals with Metastatic Neoplasms 3
Total Metastatic Neoplasm 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
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