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 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------ --multipart-boundary Content-type: text/plain Range: bytes 68204-68204/68204 --multipart-boundary--