TDMS Study 05084-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason TURMERIC OLEORESIN DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 TIME: 00:39:08 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES9561902 ROUTE: DOSED FEED NTP C#: 60015 PATHOLOGIST: R. FLEISCHMAN CAS: 458-37-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason TURMERIC OLEORESIN DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 TIME: 00:39:08 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES9561902 ROUTE: DOSED FEED NTP C#: 60015 PATHOLOGIST: R. FLEISCHMAN CAS: 458-37-7 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason TURMERIC OLEORESIN DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 TIME: 00:39:08 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES9561902 ROUTE: DOSED FEED NTP C#: 60015 PATHOLOGIST: R. FLEISCHMAN CAS: 458-37-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TURMERIC OLEORESIN ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma All Organs Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Stomach, Forestomach Squamous Cell Papilloma All Organs Malignant Lymphoma And Histiocytic Sarcoma Benign Tumors ==================================================================================================== DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 3/60 (5%) 1/60 (2%) 6/60 (10%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 9.3% 7.0% 2.6% 13.4% | 0.0% 4.9% 0.0% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 4/43 (9%) 3/43 (7%) 0/37 (0%) 4/42 (10%) | 0/39 (0%) 2/41 (5%) 0/34 (0%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 725 537 | --- 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.146 P=0.500N P=0.228N P=0.363 | P=0.657 P=0.249 (e) P=0.515 | |INCIDENTAL TUMOR | P=0.147 P=0.500N P=0.152N P=0.444 | P=0.657 P=0.249 (e) P=0.515 | |LOGISTIC REGRESSION | P=0.144 P=0.500N P=0.205N P=0.376 | P=0.657 P=0.249 (e) P=0.515 | |COCHRAN-ARMITAGE | P=0.142 | P=0.640 | |FISHER EXACT | P=0.500N P=0.182N P=0.372 | P=0.248 (e) P=0.500 | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 4/60 (7%) 1/60 (2%) 6/60 (10%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 9.3% 9.1% 2.6% 13.4% | 0.0% 4.9% 0.0% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 4/43 (9%) 3/43 (7%) 0/37 (0%) 4/42 (10%) | 0/39 (0%) 2/41 (5%) 0/34 (0%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | 729 (T) 715 725 537 | --- 729 (T) --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.201 P=0.642 P=0.228N P=0.363 | P=0.657 P=0.249 (e) P=0.515 | |INCIDENTAL TUMOR | P=0.201 P=0.584N P=0.152N P=0.444 | P=0.657 P=0.249 (e) P=0.515 | |LOGISTIC REGRESSION | P=0.198 P=0.633N P=0.205N P=0.376 | P=0.657 P=0.249 (e) P=0.515 | |COCHRAN-ARMITAGE | P=0.194 | P=0.640 | |FISHER EXACT | P=0.641N P=0.182N P=0.372 | P=0.248 (e) P=0.500 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Intestine Small | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 3/60 (5%) 3/60 (5%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 7.0% 8.1% 0.0% | 2.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 3/43 (7%) 3/37 (8%) 0/42 (0%) | 1/39 (3%) 0/41 (0%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.227N P=0.121 P=0.096 (e) | P=0.573N P=0.490N P=0.527N P=0.485N | |INCIDENTAL TUMOR | P=0.227N P=0.121 P=0.096 (e) | P=0.573N P=0.490N P=0.527N P=0.485N | |LOGISTIC REGRESSION | P=0.227N P=0.121 P=0.096 (e) | P=0.573N P=0.490N P=0.527N P=0.485N | |COCHRAN-ARMITAGE | P=0.225N | P=0.588N | |FISHER EXACT | P=0.122 P=0.122 (e) | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 4.7% 5.4% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 2/43 (5%) 2/37 (5%) 0/42 (0%) | 0/39 (0%) 0/41 (0%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.329N P=0.238 P=0.206 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.329N P=0.238 P=0.206 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.329N P=0.238 P=0.206 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.327N | (e) | |FISHER EXACT | P=0.248 P=0.248 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.2% 7.0% 2.7% 2.1% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 3/43 (7%) 1/37 (3%) 0/42 (0%) | 0/39 (0%) 0/41 (0%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | 634 729 (T) 729 (T) 627 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.445N P=0.311 P=0.741 P=0.758N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.430N P=0.121 P=0.744 P=0.691 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.441N P=0.312 P=0.759 P=0.757 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.443N | (e) | |FISHER EXACT | P=0.309 P=0.752N P=0.752N | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 3/60 (5%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 7.6% 2.4% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 0/43 (0%) 1/37 (3%) 1/42 (2%) | 0/39 (0%) 0/41 (0%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 713 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.520 (e) P=0.105 P=0.495 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.528 (e) P=0.238 P=0.495 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.523 (e) P=0.111 P=0.495 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.520 | (e) | |FISHER EXACT | (e) P=0.122 P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/60 (42%) 29/60 (48%) 37/60 (62%) 31/60 (52%) | 7/60 (12%) 8/60 (13%) 20/60 (33%) 14/60 (23%) | |ADJUSTED (b) | 55.5% 64.2% 83.8% 64.4% | 17.0% 19.5% 51.8% 33.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 2/10 (20%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 23/43 (53%) 27/43 (63%) 30/37 (81%) 25/42 (60%) | 5/39 (13%) 8/41 (20%) 16/34 (47%) 14/42 (33%) | |FIRST INCIDENCE (DAYS) | 634 455 (I) 455 (I) 457 (I) | 701 729 (T) 450 (I) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.330 P=0.276 P=0.002 ** P=0.153 | P=0.204 P=0.539 P=0.002 ** P=0.100 | |INCIDENTAL TUMOR | P=0.338 P=0.259 P=0.007 ** P=0.172 | P=0.189 P=0.511 P=0.003 ** P=0.096 | |LOGISTIC REGRESSION | P=0.336 P=0.319 P=0.006 ** P=0.174 | P=0.177 P=0.524 P=0.002 ** P=0.091 | |COCHRAN-ARMITAGE | P=0.335 | P=0.140 | |FISHER EXACT | P=0.291 P=0.022 * P=0.180 | P=0.500 P=0.004 ** P=0.074 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/60 (20%) 18/60 (30%) 18/60 (30%) 18/60 (30%) | 7/60 (12%) 5/60 (8%) 10/60 (17%) 7/60 (12%) | |ADJUSTED (b) | 25.0% 38.0% 37.2% 37.4% | 16.3% 12.2% 25.2% 14.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | |TERMINAL (d) | 7/43 (16%) 14/43 (33%) 8/37 (22%) 12/42 (29%) | 4/39 (10%) 5/41 (12%) 5/34 (15%) 3/42 (7%) | |FIRST INCIDENCE (DAYS) | 479 507 455 (I) 537 | 536 729 (T) 524 453 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.320 P=0.165 P=0.108 P=0.156 | P=0.550N P=0.354N P=0.237 P=0.562N | |INCIDENTAL TUMOR | P=0.328 P=0.154 P=0.350 P=0.224 | P=0.529 P=0.439N P=0.432 P=0.591 | |LOGISTIC REGRESSION | P=0.275 P=0.145 P=0.206 P=0.138 | P=0.521 P=0.374N P=0.280 P=0.523 | |COCHRAN-ARMITAGE | P=0.301 | P=0.537 | |FISHER EXACT | P=0.146 P=0.146 P=0.146 | P=0.381N P=0.301 P=0.611N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/60 (20%) 18/60 (30%) 20/60 (33%) 19/60 (32%) | 7/60 (12%) 5/60 (8%) 10/60 (17%) 7/60 (12%) | |ADJUSTED (b) | 25.0% 38.0% 41.0% 39.5% | 16.3% 12.2% 25.2% 14.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | |TERMINAL (d) | 7/43 (16%) 14/43 (33%) 9/37 (24%) 13/42 (31%) | 4/39 (10%) 5/41 (12%) 5/34 (15%) 3/42 (7%) | |FIRST INCIDENCE (DAYS) | 479 507 455 (I) 537 | 536 729 (T) 524 453 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.271 P=0.165 P=0.055 P=0.116 | P=0.550N P=0.354N P=0.237 P=0.562N | |INCIDENTAL TUMOR | P=0.268 P=0.154 P=0.225 P=0.162 | P=0.529 P=0.439N P=0.432 P=0.591 | |LOGISTIC REGRESSION | P=0.221 P=0.145 P=0.103 P=0.096 | P=0.521 P=0.374N P=0.280 P=0.523 | |COCHRAN-ARMITAGE | P=0.249 | P=0.537 | |FISHER EXACT | P=0.146 P=0.074 P=0.105 | P=0.381N P=0.301 P=0.611N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/60 (50%) 39/60 (65%) 45/60 (75%) 38/60 (63%) | 13/60 (22%) 12/60 (20%) 26/60 (43%) 20/60 (33%) | |ADJUSTED (b) | 62.5% 79.5% 88.1% 76.0% | 30.0% 29.3% 61.4% 43.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 4/10 (40%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 25/43 (58%) 33/43 (77%) 31/37 (84%) 30/42 (71%) | 9/39 (23%) 12/41 (29%) 18/34 (53%) 16/42 (38%) | |FIRST INCIDENCE (DAYS) | 479 455 (I) 455 (I) 457 (I) | 536 729 (T) 450 (I) 453 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.379 P=0.076 P<0.001 ** P=0.093 | P=0.212 P=0.450N P=0.004 ** P=0.167 | |INCIDENTAL TUMOR | P=0.397 P=0.069 P=0.004 ** P=0.111 | P=0.152 P=0.528N P=0.011 * P=0.117 | |LOGISTIC REGRESSION | P=0.356 P=0.070 P=0.001 ** P=0.083 | P=0.160 P=0.484N P=0.004 ** P=0.125 | |COCHRAN-ARMITAGE | P=0.366 | P=0.127 | |FISHER EXACT | P=0.070 P=0.004 ** P=0.099 | P=0.500N P=0.009 ** P=0.110 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/60 (50%) 39/60 (65%) 45/60 (75%) 39/60 (65%) | 13/60 (22%) 12/60 (20%) 26/60 (43%) 20/60 (33%) | |ADJUSTED (b) | 62.5% 79.5% 88.1% 78.0% | 30.0% 29.3% 61.4% 43.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 4/10 (40%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 1/10 (10%) | |TERMINAL (d) | 25/43 (58%) 33/43 (77%) 31/37 (84%) 31/42 (74%) | 9/39 (23%) 12/41 (29%) 18/34 (53%) 16/42 (38%) | |FIRST INCIDENCE (DAYS) | 479 455 (I) 455 (I) 457 (I) | 536 729 (T) 450 (I) 453 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.302 P=0.076 P<0.001 ** P=0.066 | P=0.212 P=0.450N P=0.004 ** P=0.167 | |INCIDENTAL TUMOR | P=0.301 P=0.069 P=0.004 ** P=0.075 | P=0.152 P=0.528N P=0.011 * P=0.117 | |LOGISTIC REGRESSION | P=0.264 P=0.070 P=0.001 ** P=0.054 | P=0.160 P=0.484N P=0.004 ** P=0.125 | |COCHRAN-ARMITAGE | P=0.283 | P=0.127 | |FISHER EXACT | P=0.070 P=0.004 ** P=0.070 | P=0.500N P=0.009 ** P=0.110 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/60 (18%) 9/60 (15%) 7/60 (12%) 11/60 (18%) | 4/60 (7%) 3/60 (5%) 4/60 (7%) 1/60 (2%) | |ADJUSTED (b) | 25.0% 20.9% 17.2% 24.1% | 10.3% 7.3% 10.8% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 10/43 (23%) 9/43 (21%) 5/37 (14%) 8/42 (19%) | 4/39 (10%) 3/41 (7%) 3/34 (9%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | 664 729 (T) 541 457 (I) | 729 (T) 729 (T) 453 (I) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.403 P=0.399N P=0.320N P=0.576 | P=0.134N P=0.473N P=0.568 P=0.158N | |INCIDENTAL TUMOR | P=0.410 P=0.360N P=0.227N P=0.521N | P=0.134N P=0.473N P=0.568 P=0.158N | |LOGISTIC REGRESSION | P=0.407 P=0.377N P=0.244N P=0.585N | P=0.141N P=0.473N P=0.618 P=0.158N | |COCHRAN-ARMITAGE | P=0.400 | P=0.153N | |FISHER EXACT | P=0.404N P=0.222N P=0.593N | P=0.500N P=0.641N P=0.182N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 7/60 (12%) 0/60 (0%) 4/60 (7%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 8.9% 15.8% 0.0% 9.5% | 2.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 3/43 (7%) 6/43 (14%) 0/37 (0%) 4/42 (10%) | 1/39 (3%) 0/41 (0%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | 609 691 --- 729 (T) | 729 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.509N P=0.267 P=0.083N P=0.630 | P=0.573N P=0.490N P=0.527N P=0.485N | |INCIDENTAL TUMOR | P=0.503N P=0.195 P=0.080N P=0.604 | P=0.573N P=0.490N P=0.527N P=0.485N | |LOGISTIC REGRESSION | P=0.503N P=0.275 P=0.067N P=0.638N | P=0.573N P=0.490N P=0.527N P=0.485N | |COCHRAN-ARMITAGE | P=0.508N | P=0.588N | |FISHER EXACT | P=0.264 P=0.059N P=0.641N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/60 (23%) 16/60 (27%) 7/60 (12%) 14/60 (23%) | 5/60 (8%) 3/60 (5%) 4/60 (7%) 1/60 (2%) | |ADJUSTED (b) | 31.0% 36.3% 17.2% 30.8% | 12.8% 7.3% 10.8% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | |TERMINAL (d) | 12/43 (28%) 15/43 (35%) 5/37 (14%) 11/42 (26%) | 5/39 (13%) 3/41 (7%) 3/34 (9%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | 609 691 541 457 (I) | 729 (T) 729 (T) 453 (I) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.527 P=0.419 P=0.133N P=0.564 | P=0.098N P=0.328N P=0.583N P=0.087N | |INCIDENTAL TUMOR | P=0.539 P=0.399 P=0.080N P=0.541N | P=0.098N P=0.328N P=0.583N P=0.087N | |LOGISTIC REGRESSION | P=0.537 P=0.445 P=0.063N P=0.576N | P=0.104N P=0.328N P=0.530N P=0.087N | |COCHRAN-ARMITAGE | P=0.526 | P=0.114N | |FISHER EXACT | P=0.417 P=0.074N P=0.585N | P=0.359N P=0.500N P=0.103N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/60 (2%) 2/58 (3%) 1/59 (2%) 0/58 (0%) | |ADJUSTED (b) | | 2.6% 5.1% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/39 (3%) 2/39 (5%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | | 729 (T) 729 (T) 667 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.228N P=0.500 P=0.740 P=0.485N | |INCIDENTAL TUMOR | | P=0.248N P=0.500 P=0.714N P=0.485N | |LOGISTIC REGRESSION | | P=0.235N P=0.500 P=0.749 P=0.485N | |COCHRAN-ARMITAGE | | P=0.247N | |FISHER EXACT | | P=0.487 P=0.748 P=0.508N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | 0/56 (0%) 2/59 (3%) 4/59 (7%) 5/60 (8%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 5.0% 11.8% 11.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 0/42 (0%) 0/37 (0%) 0/42 (0%) | 0/37 (0%) 2/40 (5%) 4/34 (12%) 4/42 (10%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 729 (T) 729 (T) 621 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.084 P=0.256 P=0.053 P=0.045 * | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.070 P=0.256 P=0.053 P=0.030 * | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.076 P=0.256 P=0.053 P=0.041 * | |COCHRAN-ARMITAGE | (e) | P=0.066 | |FISHER EXACT | (e) (e) (e) | P=0.261 P=0.066 P=0.034 * | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.4% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 0/43 (0%) 2/37 (5%) 0/42 (0%) | 0/39 (0%) 0/41 (0%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.623N (e) P=0.206 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.623N (e) P=0.206 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.623N (e) P=0.206 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.624N | (e) | |FISHER EXACT | (e) P=0.248 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 1/59 (2%) | 1/59 (2%) 1/60 (2%) 2/59 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 2.3% 2.2% 2.1% | 2.1% 2.4% 5.5% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 1/43 (2%) 0/37 (0%) 0/41 (0%) | 0/38 (0%) 1/41 (2%) 1/34 (3%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 639 627 | 522 729 (T) 704 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.549 P=0.500 P=0.500 P=0.504 | P=0.600N P=0.754N P=0.479 P=0.749N | |INCIDENTAL TUMOR | P=0.569 P=0.500 P=0.500 P=0.419 | P=0.660N P=0.658 P=0.587 P=0.661 | |LOGISTIC REGRESSION | P=0.547 P=0.500 P=0.502 P=0.491 | P=0.614N P=0.759N P=0.498 P=0.761 | |COCHRAN-ARMITAGE | P=0.547 | P=0.623N | |FISHER EXACT | P=0.500 P=0.500 P=0.496 | P=0.748N P=0.500 P=0.748N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 3/60 (5%) | |ADJUSTED (b) | 4.5% 0.0% 0.0% 0.0% | 0.0% 0.0% 5.9% 7.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/43 (2%) 0/43 (0%) 0/37 (0%) 0/42 (0%) | 0/39 (0%) 0/41 (0%) 2/34 (6%) 3/42 (7%) | |FIRST INCIDENCE (DAYS) | 717 --- --- --- | --- --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.349N P=0.242N P=0.273N P=0.242N | P=0.066 (e) P=0.209 P=0.135 | |INCIDENTAL TUMOR | P=0.343N P=0.145N P=0.140N P=0.168N | P=0.066 (e) P=0.209 P=0.135 | |LOGISTIC REGRESSION | P=0.349N P=0.232N P=0.250N P=0.235N | P=0.066 (e) P=0.209 P=0.135 | |COCHRAN-ARMITAGE | P=0.350N | P=0.053 | |FISHER EXACT | P=0.248N P=0.248N P=0.248N | (e) P=0.248 P=0.122 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 3/60 (5%) | |ADJUSTED (b) | 4.5% 0.0% 0.0% 0.0% | 0.0% 0.0% 2.9% 7.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/43 (2%) 0/43 (0%) 0/37 (0%) 0/42 (0%) | 0/39 (0%) 0/41 (0%) 1/34 (3%) 3/42 (7%) | |FIRST INCIDENCE (DAYS) | 717 --- --- --- | --- --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.349N P=0.242N P=0.273N P=0.242N | P=0.034 * (e) P=0.473 P=0.135 | |INCIDENTAL TUMOR | P=0.343N P=0.145N P=0.140N P=0.168N | P=0.034 * (e) P=0.473 P=0.135 | |LOGISTIC REGRESSION | P=0.349N P=0.232N P=0.250N P=0.235N | P=0.034 * (e) P=0.473 P=0.135 | |COCHRAN-ARMITAGE | P=0.350N | P=0.026 * | |FISHER EXACT | P=0.248N P=0.248N P=0.248N | (e) P=0.500 P=0.122 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/59 (2%) 0/59 (0%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 2/59 (3%) 0/59 (0%) | |ADJUSTED (b) | 2.3% 2.3% 0.0% 4.5% | 2.6% 2.4% 5.9% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/43 (2%) 0/42 (0%) 0/37 (0%) 1/42 (2%) | 1/39 (3%) 1/41 (2%) 2/34 (6%) 0/41 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 715 --- 678 | 729 (T) 729 (T) 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.317 P=0.758 P=0.530N P=0.500 | P=0.298N P=0.751N P=0.452 P=0.490N | |INCIDENTAL TUMOR | P=0.313 P=0.667N P=0.530N P=0.573 | P=0.298N P=0.751N P=0.452 P=0.490N | |LOGISTIC REGRESSION | P=0.316 P=0.762N P=0.530N P=0.504 | P=0.298N P=0.751N P=0.452 P=0.490N | |COCHRAN-ARMITAGE | P=0.313 | P=0.313N | |FISHER EXACT | P=0.748 P=0.504N P=0.500 | P=0.752N P=0.494 P=0.504N | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | | 4.4% 2.4% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 1/10 (10%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/39 (3%) 1/41 (2%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | | 453 (I) 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.234N P=0.488N P=0.267N P=0.232N | |INCIDENTAL TUMOR | | P=0.234N P=0.488N P=0.267N P=0.232N | |LOGISTIC REGRESSION | | P=0.242N P=0.500N P=0.220N P=0.248N | |COCHRAN-ARMITAGE | | P=0.241N | |FISHER EXACT | | P=0.500N P=0.248N P=0.248N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 2.3% 5.4% 0.0% | 0.0% 2.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 1/43 (2%) 2/37 (5%) 0/42 (0%) | 0/39 (0%) 0/41 (0%) 0/34 (0%) 0/42 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | --- 681 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.450N P=0.500 P=0.206 (e) | P=0.615N P=0.505 (e) (e) | |INCIDENTAL TUMOR | P=0.450N P=0.500 P=0.206 (e) | P=0.642N P=0.455 (e) (e) | |LOGISTIC REGRESSION | P=0.450N P=0.500 P=0.206 (e) | P=0.622N P=0.500 (e) (e) | |COCHRAN-ARMITAGE | P=0.449N | P=0.626N | |FISHER EXACT | P=0.500 P=0.248 (e) | P=0.500 (e) (e) | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 4/60 (7%) 2/60 (3%) 1/60 (2%) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 4.4% 9.3% 4.9% 2.1% | 2.1% 2.4% 5.5% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/43 (2%) 4/43 (9%) 1/37 (3%) 0/42 (0%) | 0/39 (0%) 1/41 (2%) 1/34 (3%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | 634 729 (T) 639 627 | 522 729 (T) 704 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.248N P=0.342 P=0.663 P=0.500N | P=0.602N P=0.757N P=0.476 P=0.752N | |INCIDENTAL TUMOR | P=0.223N P=0.180 P=0.674 P=0.604N | P=0.663N P=0.654 P=0.584 P=0.658 | |LOGISTIC REGRESSION | P=0.241N P=0.347 P=0.690 P=0.501N | P=0.618N P=0.762 P=0.496 P=0.758 | |COCHRAN-ARMITAGE | P=0.243N | P=0.627N | |FISHER EXACT | P=0.340 P=0.691N P=0.500N | P=0.752N P=0.500 P=0.752N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 5/60 (8%) 3/60 (5%) 1/60 (2%) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 4.4% 11.6% 7.5% 2.1% | 2.1% 4.7% 5.5% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/43 (2%) 5/43 (12%) 2/37 (5%) 0/42 (0%) | 0/39 (0%) 1/41 (2%) 1/34 (3%) 1/42 (2%) | |FIRST INCIDENCE (DAYS) | 634 729 (T) 639 627 | 522 681 704 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183N P=0.221 P=0.458 P=0.500N | P=0.484N P=0.506 P=0.476 P=0.752N | |INCIDENTAL TUMOR | P=0.163N P=0.103 P=0.458 P=0.604N | P=0.543N P=0.362 P=0.584 P=0.658 | |LOGISTIC REGRESSION | P=0.176N P=0.226 P=0.491 P=0.501N | P=0.499N P=0.416 P=0.496 P=0.758 | |COCHRAN-ARMITAGE | P=0.178N | P=0.508N | |FISHER EXACT | P=0.219 P=0.500 P=0.500N | P=0.500 P=0.500 P=0.752N | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 3/60 (5%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 4.3% 5.2% 7.1% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 0/43 (0%) 0/43 (0%) 0/37 (0%) 0/42 (0%) | 0/39 (0%) 0/41 (0%) 1/34 (3%) 3/42 (7%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 599 662 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.224 P=0.245 P=0.222 P=0.135 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.176 P=0.215 P=0.286 P=0.135 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.206 P=0.238 P=0.227 P=0.135 | |COCHRAN-ARMITAGE | (e) | P=0.195 | |FISHER EXACT | (e) (e) (e) | P=0.248 P=0.248 P=0.122 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 7/60 (12%) | 9/60 (15%) 18/60 (30%) 14/60 (23%) 9/60 (15%) | |ADJUSTED (b) | 2.3% 6.7% 3.9% 15.8% | 21.7% 38.1% 35.6% 19.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/43 (2%) 2/43 (5%) 0/37 (0%) 6/42 (14%) | 7/39 (18%) 12/41 (29%) 10/34 (29%) 6/42 (14%) | |FIRST INCIDENCE (DAYS) | 729 (T) 691 224 457 (I) | 628 467 437 662 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.016 * P=0.311 P=0.482 P=0.032 * | P=0.120N P=0.059 P=0.114 P=0.537N | |INCIDENTAL TUMOR | P=0.009 ** P=0.384 P=0.483 P=0.032 * | P=0.164N P=0.026 * P=0.123 P=0.588N | |LOGISTIC REGRESSION | P=0.015 * P=0.313 P=0.504 P=0.034 * | P=0.157N P=0.019 * P=0.139 P=0.566N | |COCHRAN-ARMITAGE | P=0.015 * | P=0.156N | |FISHER EXACT | P=0.309 P=0.500 P=0.031 * | P=0.040 * P=0.177 P=0.601N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 7/60 (12%) | 9/60 (15%) 16/60 (27%) 12/60 (20%) 7/60 (12%) | |ADJUSTED (b) | 2.3% 6.7% 3.9% 15.8% | 21.7% 35.3% 31.3% 15.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | |TERMINAL (d) | 1/43 (2%) 2/43 (5%) 0/37 (0%) 6/42 (14%) | 7/39 (18%) 12/41 (29%) 9/34 (26%) 4/42 (10%) | |FIRST INCIDENCE (DAYS) | 729 (T) 691 224 457 (I) | 628 467 437 662 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.016 * P=0.311 P=0.482 P=0.032 * | P=0.072N P=0.115 P=0.223 P=0.342N | |INCIDENTAL TUMOR | P=0.009 ** P=0.384 P=0.483 P=0.032 * | P=0.096N P=0.072 P=0.224 P=0.384N | |LOGISTIC REGRESSION | P=0.015 * P=0.313 P=0.504 P=0.034 * | P=0.087N P=0.087 P=0.268 P=0.361N | |COCHRAN-ARMITAGE | P=0.015 * | P=0.094N | |FISHER EXACT | P=0.309 P=0.500 P=0.031 * | P=0.088 P=0.316 P=0.395N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 34/60 (57%) 33/60 (55%) 42/60 (70%) 37/60 (62%) | 14/60 (23%) 18/60 (30%) 24/60 (40%) 21/60 (35%) | |ADJUSTED (b) | 72.3% 73.2% 91.1% 72.5% | 33.2% 42.8% 60.7% 48.7% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 2/10 (20%) 2/10 (20%) | 0/10 (0%) 0/10 (0%) 2/9 (22%) 0/10 (0%) | |TERMINAL (d) | 30/43 (70%) 31/43 (72%) 33/37 (89%) 28/42 (67%) | 11/39 (28%) 17/41 (41%) 19/34 (56%) 20/42 (48%) | |FIRST INCIDENCE (DAYS) | 457 (I) 455 (I) 399 457 (I) | 681 681 450 (I) 621 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.366 P=0.497N P=0.009 ** P=0.321 | P=0.331 P=0.317 P=0.013 * P=0.164 | |INCIDENTAL TUMOR | P=0.377 P=0.475N P=0.042 * P=0.423 | P=0.296 P=0.274 P=0.025 * P=0.138 | |LOGISTIC REGRESSION | P=0.369 P=0.431N P=0.036 * P=0.368 | P=0.282 P=0.283 P=0.019 * P=0.140 | |COCHRAN-ARMITAGE | P=0.365 | P=0.221 | |FISHER EXACT | P=0.500N P=0.092 P=0.355 | P=0.268 P=0.038 * P=0.114 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 18/60 (30%) 28/60 (47%) 27/60 (45%) 30/60 (50%) | 22/60 (37%) 25/60 (42%) 23/60 (38%) 17/60 (28%) | |ADJUSTED (b) | 35.8% 57.1% 53.4% 59.9% | 46.4% 53.1% 52.8% 33.4% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) | 1/10 (10%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | |TERMINAL (d) | 11/43 (26%) 22/43 (51%) 14/37 (38%) 22/42 (52%) | 14/39 (36%) 19/41 (46%) 14/34 (41%) 9/42 (21%) | |FIRST INCIDENCE (DAYS) | 455 (I) 507 224 457 (I) | 453 (I) 467 437 233 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.118 P=0.063 P=0.045 * P=0.028 * | P=0.071N P=0.426 P=0.341 P=0.183N | |INCIDENTAL TUMOR | P=0.076 P=0.037 * P=0.152 P=0.022 * | P=0.104N P=0.241 P=0.564 P=0.261N | |LOGISTIC REGRESSION | P=0.086 P=0.052 P=0.063 P=0.020 * | P=0.073N P=0.212 P=0.428 P=0.208N | |COCHRAN-ARMITAGE | P=0.089 | P=0.094N | |FISHER EXACT | P=0.045 * P=0.066 P=0.020 * | P=0.354 P=0.500 P=0.218N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TURMERIC OLEORESIN TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 40/60 (67%) 43/60 (72%) 51/60 (85%) 45/60 (75%) | 32/60 (53%) 33/60 (55%) 37/60 (62%) 34/60 (57%) | |ADJUSTED (b) | 78.3% 85.9% 94.4% 86.5% | 66.6% 70.1% 80.1% 66.4% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 1/10 (10%) 4/10 (40%) 3/10 (30%) | 1/10 (10%) 0/10 (0%) 2/9 (22%) 1/10 (10%) | |TERMINAL (d) | 32/43 (74%) 36/43 (84%) 34/37 (92%) 35/42 (83%) | 23/39 (59%) 27/41 (66%) 25/34 (74%) 25/42 (60%) | |FIRST INCIDENCE (DAYS) | 455 (I) 455 (I) 224 457 (I) | 453 (I) 467 437 233 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.377 P=0.366 P=0.005 ** P=0.200 | P=0.425N P=0.544N P=0.097 P=0.555N | |INCIDENTAL TUMOR | P=0.359 P=0.368 P=0.015 * P=0.238 | P=0.478 P=0.406 P=0.200 P=0.389 | |LOGISTIC REGRESSION | P=0.368 P=0.399 P=0.007 ** P=0.214 | P=0.535N P=0.374 P=0.119 P=0.474 | |COCHRAN-ARMITAGE | P=0.353 | P=0.479 | |FISHER EXACT | P=0.346 P=0.016 * P=0.211 | P=0.500 P=0.230 P=0.427 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 455 Female interim sacrifices(days): 450 (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).