TDMS Study 05166-01 Pathology Tables
INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
NTP Experiment-Test: 05166-01 Report: PEIRPT05
Study Type: CHRONIC Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
Facility: Hazleton Laboratories America, Inc.
Chemical CAS #: 612-82-8
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: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 70 45 75 70
Scheduled Sacrifice 10 10
Early Deaths
Moribund 1 5 37 45
Dead 1 6 5
Survivors
Terminal Sacrifice 59 39 32 10
Animals Examined Microscopically 60 45 75 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Colon (60) (45) (75) (60)
Adenocarcinoma 1 (2%)
Polyp Adenomatous 1 (2%) 4 (5%) 2 (3%)
Intestine Large, Rectum (60) (45) (74) (60)
Adenocarcinoma 1 (1%)
Polyp Adenomatous 2 (3%) 2 (3%)
Intestine Small, Duodenum (60) (45) (74) (59)
Adenocarcinoma 1 (2%)
Intestine Small, Ileum (60) (45) (75) (59)
Adenocarcinoma, Mucinous 1 (2%)
Polyp Adenomatous 1 (1%)
Intestine Small, Jejunum (60) (45) (74) (59)
Adenocarcinoma 1 (1%)
Adenocarcinoma, Cystic, Mucinous 1 (1%) 3 (5%)
Leiomyoma 1 (2%)
Polyp Adenomatous 1 (2%)
Liver (60) (45) (74) (60)
Hepatocellular Carcinoma 1 (1%) 1 (2%)
Hepatocholangiocarcinoma 1 (1%)
Neoplastic Nodule 5 (7%) 3 (5%)
Neoplastic Nodule, Multiple 2 (3%)
Pharynx (1) (8) (7)
Squamous Cell Carcinoma 2 (25%) 3 (43%)
Squamous Cell Carcinoma, Metastatic,
Zymbal's Gland 1 (13%)
Squamous Cell Papilloma 1 (100%) 5 (63%) 4 (57%)
Tongue (2) (3) (10)
Squamous Cell Carcinoma 1 (50%) 1 (10%)
Squamous Cell Papilloma 2 (100%) 2 (67%) 7 (70%)
____________________________________________________________________________________________________________________________________
Page 2
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (45) (74) (60)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (60) (45) (74) (60)
Adrenal Gland, Medulla (60) (45) (74) (60)
Pituitary Gland (58) (45) (75) (60)
Carcinoma, Metastatic, Zymbal's Gland 1 (1%)
Pars Distalis, Adenoma 3 (5%) 1 (2%) 4 (5%)
Thyroid Gland (60) (45) (74) (60)
C-Cell, Adenoma 1 (2%) 1 (2%) 2 (3%) 1 (2%)
Follicular Cell, Adenoma 1 (1%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (6) (3)
Carcinoma, Metastatic, Zymbal's Gland 2 (33%) 2 (67%)
Sarcoma 1 (33%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Clitoral Gland (60) (45) (75) (59)
Adenoma 8 (18%) 26 (35%) 11 (19%)
Carcinoma 5 (11%) 10 (13%) 16 (27%)
Sarcoma 1 (1%)
Bilateral, Adenoma 1 (2%) 6 (8%) 6 (10%)
Bilateral, Carcinoma 1 (1%) 2 (3%)
Ovary (60) (44) (75) (60)
Choriocarcinoma, Metastatic, Uterus 1 (1%)
Granulosa Cell Tumor Malignant 1 (2%)
Granulosa-Theca Tumor Benign 1 (2%)
Uterus (60) (44) (75) (60)
Choriocarcinoma 1 (1%)
Polyp Stromal 11 (18%) 9 (20%) 2 (3%) 1 (2%)
Sarcoma Stromal 1 (2%) 1 (1%)
Cervix, Polyp Stromal 1 (1%)
____________________________________________________________________________________________________________________________________
Page 3
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (60) (45) (75) (60)
Carcinoma, Metastatic, Zymbal's Gland 1 (1%)
Lymph Node, Mandibular (60) (43) (72) (60)
Basal Cell Carcinoma, Metastatic, Skin 1 (1%)
Lymph Node, Mesenteric (60) (45) (73) (60)
Spleen (60) (45) (74) (60)
Thymus (54) (32) (67) (45)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (56) (42) (73) (54)
Adenocarcinoma 1 (2%) 3 (4%) 5 (9%)
Adenocarcinoma, Multiple 1 (2%)
Fibroadenoma 2 (4%) 1 (2%) 3 (4%)
Fibroadenoma, Multiple 1 (1%)
Skin (60) (45) (75) (59)
Basal Cell Adenoma 3 (7%) 5 (7%) 3 (5%)
Basal Cell Adenoma, Multiple 2 (3%)
Basal Cell Carcinoma 5 (7%) 4 (7%)
Keratoacanthoma 1 (2%)
Squamous Cell Carcinoma 2 (4%) 3 (4%) 7 (12%)
Squamous Cell Carcinoma, Multiple 1 (1%)
Squamous Cell Papilloma 1 (2%) 5 (7%) 5 (8%)
Squamous Cell Papilloma, Multiple 1 (1%)
Sebaceous Gland, Adenoma 1 (2%)
Sebaceous Gland, Carcinoma 1 (1%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Skeletal Muscle (1)
Sarcoma 1 (100%)
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (45) (75) (60)
Astrocytoma Malignant 1 (2%) 1 (1%)
Carcinoma, Metastatic, Zymbal's Gland 2 (3%) 3 (5%)
Glioma Malignant 1 (1%) 1 (2%)
Meningioma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
Page 4
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (45) (74) (60)
Alveolar/Bronchiolar Adenoma 1 (2%) 1 (2%) 3 (4%) 3 (5%)
Alveolar/Bronchiolar Carcinoma 1 (2%)
Basal Cell Carcinoma, Metastatic, Skin 1 (1%)
Carcinoma, Metastatic, Clitoral Gland 1 (1%) 2 (3%)
Carcinoma, Metastatic, Uncertain Primary Site 1 (2%)
Carcinoma, Metastatic, Zymbal's Gland 2 (3%) 1 (2%)
Squamous Cell Carcinoma, Metastatic, Pharynx 1 (2%)
Mediastinum, Sarcoma, Metastatic, Skeletal
Muscle 1 (1%)
Nose (60) (44) (75) (60)
Carcinoma, Metastatic, Zymbal's Gland 1 (1%)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (1)
Canal, Squamous Cell Papilloma 1 (100%)
Eye (1) (4) (4)
Conjunctiva, Squamous Cell Carcinoma 1 (25%)
Zymbal's Gland (57) (44) (73) (60)
Adenoma 4 (9%) 9 (12%) 12 (20%)
Carcinoma 2 (5%) 20 (27%) 34 (57%)
Bilateral, Adenoma 2 (3%)
Bilateral, Carcinoma 2 (3%) 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (45) (74) (60)
Renal Tubule, Adenoma 1 (2%)
Urinary Bladder (60) (45) (75) (60)
Sarcoma Stromal, Metastatic, Uterus 1 (1%)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(45) *(75) *(60)
Leukemia Mononuclear 1 (2%) 3 (7%) 6 (8%) 4 (7%)
Lymphoma Malignant 1 (2%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 5
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS FEMALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 18 33 71 58
Total Primary Neoplasms 19 55 157 157
Total Animals with Benign Neoplasms 17 24 54 41
Total Benign Neoplasms 18 37 92 67
Total Animals with Malignant Neoplasms 1 14 49 56
Total Malignant Neoplasms 1 18 65 90
Total Animals with Metastatic Neoplasms 11 9
Total Metastatic Neoplasm 16 10
Total Animals with Malignant Neoplasms 1
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: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially in Study 70 45 75 70
Scheduled Sacrifice 10 10
Early Deaths
Moribund 2 19 45
Dead 2 5 15
Accident 1
Survivors
Terminal Sacrifice 60 41 49
Dead 1
Animals Examined Microscopically 60 45 75 60
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Cecum (60) (45) (75) (58)
Polyp Adenomatous 1 (1%) 1 (2%)
Intestine Large, Colon (60) (45) (75) (58)
Adenocarcinoma 5 (9%)
Adenocarcinoma, Cystic, Mucinous 1 (2%)
Polyp Adenomatous 5 (7%) 3 (5%)
Polyp Adenomatous, Multiple 2 (3%)
Intestine Large, Rectum (60) (44) (75) (60)
Adenocarcinoma 1 (2%)
Polyp Adenomatous 3 (5%)
Intestine Small, Duodenum (60) (44) (75) (56)
Adenocarcinoma, Cystic, Mucinous 2 (3%)
Intestine Small, Ileum (60) (44) (75) (54)
Adenocarcinoma, Multiple 1 (2%)
Polyp Adenomatous 1 (1%) 1 (2%)
Intestine Small, Jejunum (60) (44) (75) (55)
Adenocarcinoma, Cystic, Multiple, Mucinous 1 (2%)
Adenocarcinoma, Cystic, Mucinous 1 (1%) 6 (11%)
Liver (60) (45) (75) (60)
Cholangiocarcinoma 1 (2%)
Hepatoblastoma 1 (2%)
Hepatocellular Carcinoma 11 (15%) 10 (17%)
Hepatocellular Carcinoma, Multiple 1 (1%) 2 (3%)
Neoplastic Nodule 15 (20%) 15 (25%)
Neoplastic Nodule, Multiple 14 (19%) 11 (18%)
Pancreas (60) (44) (75) (57)
Pharynx (3) (3)
Squamous Cell Carcinoma 1 (33%) 1 (33%)
Squamous Cell Papilloma 2 (67%) 2 (67%)
Page 7
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM - cont
Stomach, Glandular (60) (45) (75) (59)
Tongue (1) (3)
Squamous Cell Carcinoma 2 (67%)
Squamous Cell Papilloma 1 (100%)
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
Heart (60) (45) (75) (59)
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Gland, Cortex (60) (44) (75) (59)
Adrenal Gland, Medulla (60) (45) (75) (59)
Pheochromocytoma Benign 2 (4%) 1 (1%) 3 (5%)
Pituitary Gland (60) (45) (75) (60)
Pars Distalis, Adenoma 1 (2%) 2 (4%) 4 (5%) 1 (2%)
Thyroid Gland (60) (44) (75) (60)
C-Cell, Adenoma 2 (3%) 1 (2%) 3 (4%) 1 (2%)
Follicular Cell, Adenoma 1 (2%) 1 (2%) 1 (1%) 1 (2%)
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
Tissue NOS (1) (4)
Sarcoma 1 (25%)
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (60) (45) (75) (60)
Preputial Gland (60) (45) (75) (60)
Adenoma 2 (3%) 4 (9%) 4 (5%) 8 (13%)
Carcinoma 2 (3%) 1 (2%)
Testes (60) (45) (75) (60)
Bilateral, Interstitial Cell, Adenoma 7 (12%) 9 (20%) 6 (8%) 1 (2%)
Interstitial Cell, Adenoma 17 (28%) 17 (38%) 20 (27%) 1 (2%)
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Bone Marrow (60) (44) (75) (60)
Lymph Node (60) (45) (75) (60)
Mediastinal, Squamous Cell Carcinoma,
Metastatic, Skin 1 (2%)
Lymph Node, Mandibular (60) (45) (74) (60)
Page 8
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM - cont
Squamous Cell Carcinoma, Metastatic, Skin 1 (2%)
Lymph Node, Mesenteric (60) (44) (75) (56)
Spleen (60) (45) (75) (55)
Fibroma 1 (2%)
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (60) (44) (75) (60)
Basal Cell Adenoma 7 (16%) 17 (23%) 8 (13%)
Basal Cell Adenoma, Multiple 3 (7%) 35 (47%) 21 (35%)
Basal Cell Carcinoma 1 (2%) 4 (5%) 2 (3%)
Keratoacanthoma 1 (2%) 1 (2%) 7 (9%) 5 (8%)
Keratoacanthoma, Multiple 1 (1%)
Squamous Cell Carcinoma 1 (2%) 8 (11%) 10 (17%)
Squamous Cell Carcinoma, Multiple 1 (2%) 2 (3%) 3 (5%)
Squamous Cell Papilloma 8 (11%) 13 (22%)
Squamous Cell Papilloma, Multiple 2 (3%)
Sebaceous Gland, Adenoma 6 (8%) 4 (7%)
Sebaceous Gland, Adenoma, Multiple 1 (1%) 1 (2%)
Subcutaneous Tissue, Fibroma 2 (3%)
Subcutaneous Tissue, Fibrosarcoma 1 (2%)
Subcutaneous Tissue, Schwannoma Benign 1 (1%)
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Brain (60) (45) (75) (60)
Carcinoma, Metastatic, Zymbal's Gland 1 (1%)
Glioma Malignant 1 (1%)
Glioma Malignant, Focal, Mild 1 (2%)
Meningioma Malignant 1 (2%)
Cranial Nerve, Meninges, Carcinoma,
Metastatic, Zymbal's Gland 1 (2%)
Meninges, Sarcoma 1 (1%)
____________________________________________________________________________________________________________________________________
Page 9
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (60) (45) (75) (60)
Alveolar/Bronchiolar Adenoma 1 (2%) 6 (8%) 4 (7%)
Alveolar/Bronchiolar Adenoma, Multiple 1 (1%) 2 (3%)
Alveolar/Bronchiolar Carcinoma 1 (1%)
Carcinoma, Metastatic, Zymbal's Gland 1 (2%) 3 (4%) 3 (5%)
Squamous Cell Carcinoma, Metastatic, Skin 1 (2%) 3 (5%)
Nose (60) (45) (75) (60)
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Ear (2)
Squamous Cell Carcinoma 1 (50%)
Canal, Squamous Cell Papilloma 1 (50%)
Zymbal's Gland (59) (45) (75) (59)
Adenoma 1 (2%) 1 (2%) 13 (17%) 13 (22%)
Carcinoma 2 (4%) 20 (27%) 22 (37%)
Bilateral, Adenoma 3 (5%)
Bilateral, Carcinoma 1 (1%) 1 (2%)
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (60) (45) (75) (59)
Lipoma 1 (1%)
Urinary Bladder (60) (45) (75) (59)
____________________________________________________________________________________________________________________________________
SYSTEMIC LESIONS
Multiple Organs *(60) *(45) *(75) *(60)
Leukemia Mononuclear 1 (2%) 1 (1%) 1 (2%)
Lymphoma Malignant Histiocytic 1 (1%)
Lymphoma Malignant Undifferentiated Cell 1 (1%)
Mesothelioma Malignant 3 (4%) 4 (7%)
____________________________________________________________________________________________________________________________________
* Number of animals with any tissue examined microscopically
Page 10
NTP Experiment-Test: 05166-01 INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a) Report: PEIRPT05
Study Type: CHRONIC 3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE Date: 09/18/94
Route: DOSED WATER Time: 00:50:59
____________________________________________________________________________________________________________________________________
FISCHER 344 RATS MALE CONTROL 0.003 0.007 0.015
____________________________________________________________________________________________________________________________________
TUMOR SUMMARY
Total Animals with Primary Neoplasms (b) 28 38 73 58
Total Primary Neoplasms 34 54 237 214
Total Animals with Benign Neoplasms 28 34 66 47
Total Benign Neoplasms 33 48 175 134
Total Animals with Malignant Neoplasms 1 6 48 50
Total Malignant Neoplasms 1 6 62 80
Total Animals with Metastatic Neoplasms 2 5 11
Total Metastatic Neoplasm 3 6 11
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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