TDMS Study 05169-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: HLA, VA C. I. DIRECT BLUE 15 DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 TIME: 03:50:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61290 PATHOLOGIST: B. ULLAND S. EUSTIS CAS: 2429-74-5 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: HLA, VA C. I. DIRECT BLUE 15 DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 TIME: 03:50:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61290 PATHOLOGIST: B. ULLAND S. EUSTIS CAS: 2429-74-5 RATS(FISCHER344) ---------------------------- 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 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: HLA, VA C. I. DIRECT BLUE 15 DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 TIME: 03:50:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61290 PATHOLOGIST: B. ULLAND S. EUSTIS CAS: 2429-74-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF C. I. DIRECT BLUE 15 ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma Malignant Pheochromocytoma: Benign, Complex, Malignant, NOS Brain Astrocytoma Malignant Clitoral/Preputial Gland Adenoma Carcinoma Carcinoma or Adenoma Intestine Large Carcinoma Polyp Adenomatous Intestine Small Carcinoma Carcinoma or Adenoma Kidney: Renal Tubule Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) Papilloma Squamous or Papilloma Squamous Cell Carcinoma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Pharynx Squamous Cell Carcinoma Squamous Cell Papilloma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin Basal Cell Adenoma Basal Cell Carcinoma Keratoacanthoma Squamous Cell Carcinoma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Squamous Cell Papilloma Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma Skin: Sebaceous Gland Carcinoma, Basal Cell Carcinoma or Adenoma Skin: Subcutaneous Tissue Fibroma Neurofibroma or Fibroma Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma Testes Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Thyroid Gland: Follicular Cell Adenoma Carcinoma NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: HLA, VA C. I. DIRECT BLUE 15 DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 TIME: 03:50:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61290 PATHOLOGIST: B. ULLAND S. EUSTIS CAS: 2429-74-5 Carcinoma or Adenoma Tongue Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma Zymbal's Gland Adenoma Carcinoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Adenoma Carcinoma Carcinoma or Adenoma Intestine Large Polyp Adenomatous Intestine Small Carcinoma Carcinoma or Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) Papilloma Squamous or Papilloma Squamous Cell Carcinoma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Pharynx Squamous Cell Carcinoma Squamous Cell Papilloma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Squamous Cell Papilloma Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma Skin: Subcutaneous Tissue Fibroma Neurofibroma or Fibroma Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Tongue Squamous Cell Carcinoma Squamous Cell Carcinoma or Papilloma Squamous Squamous Cell Papilloma Uterus Carcinoma Polyp Stromal Sarcoma Stromal or Polyp Stromal Zymbal's Gland Adenoma Carcinoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: HLA, VA C. I. DIRECT BLUE 15 DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 TIME: 03:50:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1ES9565503 ROUTE: DOSED WATER NTP C#: 61290 PATHOLOGIST: B. ULLAND S. EUSTIS CAS: 2429-74-5 or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 5/35 (14%) 19/65 (29%) 17/50 (34%) | 4/50 (8%) 4/35 (11%) 7/65 (11%) 1/50 (2%) | |ADJUSTED (b) | 39.9% 28.9% 72.7% 89.2% | 10.0% 25.5% 21.2% 7.1% | |TERMINAL (d) | 13/37 (35%) 0/8 (0%) 5/11 (45%) 1/2 (50%) | 4/40 (10%) 3/13 (23%) 2/22 (9%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 637 566 460 460 | 682 (T) 506 368 620 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.489 P<0.001 ** P<0.001 ** | P=0.223 P=0.121 P=0.090 P=0.555 | |INCIDENTAL TUMOR | P=0.012 * P=0.058N P=0.345 P=0.173 | P=0.420N P=0.198 P=0.352 P=0.644N | |LOGISTIC REGRESSION | P=0.002 ** P=0.210N P=0.253 P=0.012 * | P=0.303N P=0.298 P=0.385 P=0.718N | |COCHRAN-ARMITAGE | P=0.263 | P=0.135N | |FISHER EXACT | P=0.052N P=0.453N P=0.500 | P=0.432 P=0.433 P=0.181N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 2/65 (3%) 1/50 (2%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 11.7% 5.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 1/11 (9%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 628 565 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.035 * (e) P=0.105 P=0.343 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.148 (e) P=0.226 P=0.731 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.153 (e) P=0.208 P=0.527 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.273 | (e) | |FISHER EXACT | (e) P=0.317 P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 5/35 (14%) 21/65 (32%) 17/50 (34%) | 4/50 (8%) 4/35 (11%) 7/65 (11%) 1/50 (2%) | |ADJUSTED (b) | 39.9% 28.9% 77.9% 89.2% | 10.0% 25.5% 21.2% 7.1% | |TERMINAL (d) | 13/37 (35%) 0/8 (0%) 6/11 (55%) 1/2 (50%) | 4/40 (10%) 3/13 (23%) 2/22 (9%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 637 566 460 460 | 682 (T) 506 368 620 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.489 P<0.001 ** P<0.001 ** | P=0.223 P=0.121 P=0.090 P=0.555 | |INCIDENTAL TUMOR | P=0.008 ** P=0.058N P=0.187 P=0.173 | P=0.420N P=0.198 P=0.352 P=0.644N | |LOGISTIC REGRESSION | P=0.001 ** P=0.210N P=0.134 P=0.012 * | P=0.303N P=0.298 P=0.385 P=0.718N | |COCHRAN-ARMITAGE | P=0.253 | P=0.135N | |FISHER EXACT | P=0.052N P=0.567 P=0.500 | P=0.432 P=0.433 P=0.181N | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/35 (3%) 1/65 (2%) 2/50 (4%) | 1/50 (2%) 0/35 (0%) 2/65 (3%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 6.7% 2.0% 16.7% | 2.0% 0.0% 7.2% 2.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 1/22 (5%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 646 574 479 | 500 --- 638 316 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.029 * P=0.305 P=0.530 P=0.066 | P=0.290 P=0.585N P=0.418 P=0.720 | |INCIDENTAL TUMOR | P=0.328 P=0.669 P=0.852 P=0.532 | P=0.496N P=0.205N P=0.717N P=0.345N | |LOGISTIC REGRESSION | P=0.161 P=0.392 P=0.591 P=0.236 | P=0.535N P=0.535N P=0.646 P=0.441N | |COCHRAN-ARMITAGE | P=0.176 | P=0.542 | |FISHER EXACT | P=0.412 P=0.565 P=0.247 | P=0.588N P=0.598 P=0.753N | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/49 (12%) 2/35 (6%) 12/64 (19%) 8/48 (17%) | 5/50 (10%) 5/31 (16%) 12/64 (19%) 12/50 (24%) | |ADJUSTED (b) | 15.5% 21.3% 51.2% 59.2% | 12.1% 30.4% 36.5% 75.9% | |TERMINAL (d) | 5/37 (14%) 1/8 (13%) 4/11 (36%) 0/2 (0%) | 4/40 (10%) 3/13 (23%) 5/22 (23%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 565 660 530 372 | 666 558 432 453 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.560 P=0.002 ** P<0.001 ** | P<0.001 ** P=0.074 P=0.007 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.039 * P=0.504N P=0.119 P=0.432 | P=0.008 ** P=0.225 P=0.140 P=0.039 * | |LOGISTIC REGRESSION | P=0.039 * P=0.466N P=0.143 P=0.228 | P=0.003 ** P=0.197 P=0.077 P=0.006 ** | |COCHRAN-ARMITAGE | P=0.190 | P=0.043 * | |FISHER EXACT | P=0.270N P=0.251 P=0.371 | P=0.315 P=0.150 P=0.054 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 3/35 (9%) 11/64 (17%) 1/48 (2%) | 2/50 (4%) 6/31 (19%) 12/64 (19%) 15/50 (30%) | |ADJUSTED (b) | 5.4% 15.0% 27.0% 7.7% | 5.0% 25.6% 30.1% 53.5% | |TERMINAL (d) | 2/37 (5%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 2/40 (5%) 1/13 (8%) 3/22 (14%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 578 372 600 | 682 (T) 506 253 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.092 P=0.107 P=0.003 ** P=0.379 | P<0.001 ** P=0.010 ** P=0.002 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.117N P=0.510 P=0.260 P=0.756 | P=0.033 * P=0.099 P=0.033 * P=0.091 | |LOGISTIC REGRESSION | P=0.441N P=0.300 P=0.056 P=0.687 | P=0.025 * P=0.057 P=0.063 P=0.005 ** | |COCHRAN-ARMITAGE | P=0.445N | P<0.001 ** | |FISHER EXACT | P=0.343 P=0.027 * P=0.508N | P=0.032 * P=0.015 * P<0.001 ** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/49 (16%) 5/35 (14%) 23/64 (36%) 9/48 (19%) | 7/50 (14%) 11/31 (35%) 24/64 (38%) 27/50 (54%) | |ADJUSTED (b) | 20.8% 33.1% 64.3% 62.4% | 17.0% 49.7% 57.7% 89.3% | |TERMINAL (d) | 7/37 (19%) 1/8 (13%) 4/11 (36%) 0/2 (0%) | 6/40 (15%) 4/13 (31%) 8/22 (36%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 565 578 372 372 | 666 506 253 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.141 P<0.001 ** P<0.001 ** | P<0.001 ** P=0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.312 P=0.640N P=0.046 * P=0.394 | P<0.001 ** P=0.035 * P=0.008 ** P=0.002 ** | |LOGISTIC REGRESSION | P=0.121 P=0.547 P=0.019 * P=0.232 | P<0.001 ** P=0.028 * P=0.010 * P<0.001 ** | |COCHRAN-ARMITAGE | P=0.301 | P<0.001 ** | |FISHER EXACT | P=0.525N P=0.017 * P=0.481 | P=0.025 * P=0.004 ** P<0.001 ** | |=================================================================================================================================| | | |Intestine Large: Colon | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 4/65 (6%) 3/50 (6%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 14.4% 12.1% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 628 505 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002 ** (e) P=0.025 * P=0.044 * | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.180 (e) P=0.390 P=0.514 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.034 * (e) P=0.072 P=0.156 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.051 | (e) | |FISHER EXACT | (e) P=0.098 P=0.121 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Intestine Large: Colon | | Polyp Adenomatous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/35 (3%) 2/65 (3%) 5/50 (10%) | 0/50 (0%) 0/35 (0%) 3/65 (5%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 4.0% 6.3% 41.0% | 0.0% 0.0% 11.7% 12.5% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 2/22 (9%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 579 559 502 | --- --- 640 646 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.392 P=0.193 P<0.001 ** | P=0.017 * (e) P=0.053 P=0.165 | |INCIDENTAL TUMOR | P=0.025 * P=0.690 P=0.608 P=0.202 | P=0.123 (e) P=0.113 P=0.500 | |LOGISTIC REGRESSION | P=0.005 ** P=0.471 P=0.317 P=0.010 ** | P=0.062 (e) P=0.094 P=0.347 | |COCHRAN-ARMITAGE | P=0.010 * | P=0.279 | |FISHER EXACT | P=0.412 P=0.317 P=0.028 * | (e) P=0.177 P=0.500 | |=================================================================================================================================| | | |Intestine Small | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 2/50 (4%) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 8.2% | 0.0% 0.0% 1.8% 19.4% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 479 | --- --- 479 578 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.022 * (e) (e) P=0.126 | P=0.005 ** (e) P=0.527 P=0.016 * | |INCIDENTAL TUMOR | P=0.132 (e) (e) P=0.604 | P=0.087 (e) P=0.860 P=0.384 | |LOGISTIC REGRESSION | P=0.078 (e) (e) P=0.304 | P=0.032 * (e) P=0.688 P=0.075 | |COCHRAN-ARMITAGE | P=0.052 | P=0.025 * | |FISHER EXACT | (e) (e) P=0.247 | (e) P=0.565 P=0.121 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 2/50 (4%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 8.2% | 0.0% 0.0% 0.0% 19.4% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 479 | --- --- --- 578 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.022 * (e) (e) P=0.126 | P=0.002 ** (e) (e) P=0.016 * | |INCIDENTAL TUMOR | P=0.132 (e) (e) P=0.604 | P=0.033 * (e) (e) P=0.384 | |LOGISTIC REGRESSION | P=0.078 (e) (e) P=0.304 | P=0.008 ** (e) (e) P=0.075 | |COCHRAN-ARMITAGE | P=0.052 | P=0.014 * | |FISHER EXACT | (e) (e) P=0.247 | (e) (e) P=0.121 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 2/50 (4%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 23.8% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 624 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** (e) (e) P=0.012 * | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.049 * (e) (e) P=0.455 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.010 * (e) (e) P=0.066 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.052 | (e) | |FISHER EXACT | (e) (e) P=0.247 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 6/35 (17%) 8/65 (12%) 7/50 (14%) | 0/50 (0%) 0/35 (0%) 2/65 (3%) 4/50 (8%) | |ADJUSTED (b) | 0.0% 45.9% 37.5% 44.2% | 0.0% 0.0% 6.8% 37.0% | |TERMINAL (d) | 0/37 (0%) 3/8 (38%) 2/11 (18%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 1/22 (5%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- 544 579 463 | --- --- 625 585 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** (e) P=0.171 P=0.001 ** | |INCIDENTAL TUMOR | P=0.015 * P=0.002 ** P=0.023 * P=0.120 | P=0.009 ** (e) P=0.332 P=0.108 | |LOGISTIC REGRESSION | P=0.003 ** P=0.002 ** P=0.003 ** P=0.003 ** | P=0.002 ** (e) P=0.246 P=0.016 * | |COCHRAN-ARMITAGE | P=0.046 * | P=0.011 * | |FISHER EXACT | P=0.004 ** P=0.009 ** P=0.006 ** | (e) P=0.317 P=0.059 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 4/50 (8%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 3.1% 44.6% | 0.0% 0.0% 0.0% 3.7% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 632 547 | --- --- --- 564 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.446 P<0.001 ** | P=0.155 (e) (e) P=0.394 | |INCIDENTAL TUMOR | P=0.007 ** (e) P=0.852 P=0.226 | P=0.364 (e) (e) P=0.916 | |LOGISTIC REGRESSION | P<0.001 ** (e) P=0.540 P=0.009 ** | P=0.242 (e) (e) P=0.587 | |COCHRAN-ARMITAGE | P=0.007 ** | P=0.211 | |FISHER EXACT | (e) P=0.565 P=0.059 | (e) (e) P=0.500 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 6/35 (17%) 9/65 (14%) 11/50 (22%) | 0/50 (0%) 0/35 (0%) 2/65 (3%) 5/50 (10%) | |ADJUSTED (b) | 0.0% 45.9% 39.4% 69.9% | 0.0% 0.0% 6.8% 39.3% | |TERMINAL (d) | 0/37 (0%) 3/8 (38%) 2/11 (18%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 1/22 (5%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- 544 579 463 | --- --- 625 564 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** (e) P=0.171 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.002 ** P=0.021 * P=0.025 * | P=0.004 ** (e) P=0.332 P=0.099 | |LOGISTIC REGRESSION | P<0.001 ** P=0.002 ** P=0.002 ** P<0.001 ** | P<0.001 ** (e) P=0.246 P=0.010 ** | |COCHRAN-ARMITAGE | P=0.002 ** | P=0.004 ** | |FISHER EXACT | P=0.004 ** P=0.005 ** P<0.001 ** | (e) P=0.317 P=0.028 * | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 6/35 (17%) 9/65 (14%) 11/50 (22%) | 0/50 (0%) 0/35 (0%) 2/65 (3%) 5/50 (10%) | |ADJUSTED (b) | 0.0% 45.9% 39.4% 69.9% | 0.0% 0.0% 6.8% 39.3% | |TERMINAL (d) | 0/37 (0%) 3/8 (38%) 2/11 (18%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 1/22 (5%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- 544 579 463 | --- --- 625 564 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** (e) P=0.171 P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.002 ** P=0.021 * P=0.025 * | P=0.004 ** (e) P=0.332 P=0.099 | |LOGISTIC REGRESSION | P<0.001 ** P=0.002 ** P=0.002 ** P<0.001 ** | P<0.001 ** (e) P=0.246 P=0.010 ** | |COCHRAN-ARMITAGE | P=0.002 ** | P=0.004 ** | |FISHER EXACT | P=0.004 ** P=0.005 ** P<0.001 ** | (e) P=0.317 P=0.028 * | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/35 (3%) 4/65 (6%) 1/50 (2%) | 1/50 (2%) 2/35 (6%) 1/65 (2%) 0/50 (0%) | |ADJUSTED (b) | 5.0% 12.5% 15.4% 6.7% | 2.5% 10.9% 4.5% 0.0% | |TERMINAL (d) | 1/37 (3%) 1/8 (13%) 1/11 (9%) 0/2 (0%) | 1/40 (3%) 1/13 (8%) 1/22 (5%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 589 680 (T) 579 583 | 682 (T) 529 682 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.153 P=0.612 P=0.187 P=0.534 | P=0.609N P=0.209 P=0.623 P=0.923N | |INCIDENTAL TUMOR | P=0.583 P=0.728N P=0.675 P=0.452N | P=0.447N P=0.395 P=0.623 P=0.923N | |LOGISTIC REGRESSION | P=0.563 P=0.698N P=0.448 P=0.658N | P=0.324N P=0.399 P=0.623 P=0.923N | |COCHRAN-ARMITAGE | P=0.441N | P=0.215N | |FISHER EXACT | P=0.633N P=0.471 P=0.500N | P=0.367 P=0.683N P=0.500N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | 4/50 (8%) 3/35 (9%) 2/65 (3%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 9.6% 15.0% 6.8% 27.7% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 3/40 (8%) 1/13 (8%) 1/22 (5%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 664 506 625 547 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.312 P=0.308 P=0.575N P=0.194 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.345N P=0.640N P=0.320N P=0.631 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.400N P=0.592 P=0.387N P=0.641 | |COCHRAN-ARMITAGE | (e) | P=0.194N | |FISHER EXACT | (e) (e) (e) | P=0.612 P=0.225N P=0.339N | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 0/50 (0%) | 16/50 (32%) 4/35 (11%) 16/65 (25%) 4/50 (8%) | |ADJUSTED (b) | 0.0% 0.0% 2.3% 0.0% | 40.0% 20.9% 44.9% 28.1% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 16/40 (40%) 1/13 (8%) 6/22 (27%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 605 --- | 682 (T) 579 555 502 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.600 (e) P=0.505 (e) | P=0.120 P=0.363N P=0.094 P=0.214 | |INCIDENTAL TUMOR | P=0.761N (e) P=0.852 (e) | P=0.164N P=0.141N P=0.586 P=0.578N | |LOGISTIC REGRESSION | P=0.714 (e) P=0.571 (e) | P=0.245N P=0.162N P=0.559 P=0.317N | |COCHRAN-ARMITAGE | P=0.714 | P=0.008N** | |FISHER EXACT | (e) P=0.565 (e) | P=0.024N* P=0.252N P=0.003N** | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 0/50 (0%) | 18/50 (36%) 7/35 (20%) 17/65 (26%) 6/50 (12%) | |ADJUSTED (b) | 0.0% 0.0% 2.3% 0.0% | 43.8% 33.5% 46.2% 48.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 17/40 (43%) 2/13 (15%) 6/22 (27%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- --- 605 --- | 664 506 555 502 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.600 (e) P=0.505 (e) | P=0.059 P=0.504 P=0.121 P=0.045 * | |INCIDENTAL TUMOR | P=0.761N (e) P=0.852 (e) | P=0.123N P=0.223N P=0.426N P=0.604 | |LOGISTIC REGRESSION | P=0.714 (e) P=0.571 (e) | P=0.228N P=0.284N P=0.519N P=0.439N | |COCHRAN-ARMITAGE | P=0.714 | P=0.007N** | |FISHER EXACT | (e) P=0.565 (e) | P=0.087N P=0.175N P=0.005N** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 9/35 (26%) 18/65 (28%) 15/50 (30%) | 2/50 (4%) 3/35 (9%) 12/65 (18%) 9/50 (18%) | |ADJUSTED (b) | 0.0% 55.8% 55.9% 53.8% | 5.0% 9.5% 32.7% 48.0% | |TERMINAL (d) | 0/37 (0%) 3/8 (38%) 1/11 (9%) 0/2 (0%) | 2/40 (5%) 0/13 (0%) 3/22 (14%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- 316 460 372 | 682 (T) 463 583 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.213 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.012 * P<0.001 ** P=0.005 ** P=0.028 * | P=0.119 P=0.684 P=0.068 P=0.134 | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.015 * P=0.491 P=0.008 ** P=0.035 * | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.018 * | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.334 P=0.016 * P=0.026 * | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/35 (3%) 6/65 (9%) 2/50 (4%) | 0/50 (0%) 1/35 (3%) 8/65 (12%) 6/50 (12%) | |ADJUSTED (b) | 2.7% 2.9% 13.4% 11.6% | 0.0% 7.7% 18.0% 40.3% | |TERMINAL (d) | 1/37 (3%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 1/13 (8%) 0/22 (0%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 680 (T) 293 502 479 | --- 682 (T) 432 359 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.055 P=0.557 P=0.040 * P=0.117 | P<0.001 ** P=0.277 P=0.005 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.568N P=0.611 P=0.424 P=0.631 | P=0.132 P=0.277 P=0.257 P=0.088 | |LOGISTIC REGRESSION | P=0.503 P=0.739N P=0.141 P=0.461 | P=0.015 * P=0.277 P=0.023 * P=0.023 * | |COCHRAN-ARMITAGE | P=0.350 | P=0.010 * | |FISHER EXACT | P=0.657 P=0.110 P=0.500 | P=0.412 P=0.009 ** P=0.013 * | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 10/35 (29%) 24/65 (37%) 17/50 (34%) | 2/50 (4%) 4/35 (11%) 19/65 (29%) 15/50 (30%) | |ADJUSTED (b) | 2.7% 57.0% 61.9% 59.2% | 5.0% 16.5% 43.2% 72.7% | |TERMINAL (d) | 1/37 (3%) 3/8 (38%) 1/11 (9%) 0/2 (0%) | 2/40 (5%) 1/13 (8%) 3/22 (14%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 680 (T) 293 460 372 | 682 (T) 463 432 359 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.079 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.020 * P<0.001 ** P=0.004 ** P=0.020 * | P=0.022 * P=0.369 P=0.023 * P=0.011 * | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.294 P=0.005 ** P=0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.187 P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |Pharynx | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/35 (0%) 4/65 (6%) 2/50 (4%) | 0/50 (0%) 0/35 (0%) 5/65 (8%) 3/50 (6%) | |ADJUSTED (b) | 2.7% 0.0% 8.8% 11.6% | 0.0% 0.0% 12.1% 9.4% | |TERMINAL (d) | 1/37 (3%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) --- 572 479 | --- --- 524 359 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033 * P=0.800N P=0.128 P=0.117 | P=0.006 ** (e) P=0.029 * P=0.065 | |INCIDENTAL TUMOR | P=0.395 P=0.800N P=0.588 P=0.631 | P=0.406 (e) P=0.373 P=0.576 | |LOGISTIC REGRESSION | P=0.264 P=0.800N P=0.292 P=0.461 | P=0.112 (e) P=0.074 P=0.289 | |COCHRAN-ARMITAGE | P=0.280 | P=0.058 | |FISHER EXACT | P=0.588N P=0.274 P=0.500 | (e) P=0.054 P=0.121 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Pharynx | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 9/35 (26%) 17/65 (26%) 15/50 (30%) | 0/50 (0%) 2/35 (6%) 11/65 (17%) 7/50 (14%) | |ADJUSTED (b) | 0.0% 55.8% 51.9% 53.8% | 0.0% 5.9% 29.2% 28.8% | |TERMINAL (d) | 0/37 (0%) 3/8 (38%) 1/11 (9%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 2/22 (9%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 316 460 372 | --- 463 583 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.165 P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.012 * P<0.001 ** P=0.009 ** P=0.028 * | P=0.185 P=0.604 P=0.031 * P=0.403 | |LOGISTIC REGRESSION | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.012 * P=0.187 P=0.002 ** P=0.022 * | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.010 ** | |FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.167 P=0.001 ** P=0.006 ** | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 1/34 (3%) 3/63 (5%) 3/50 (6%) | 18/49 (37%) 10/35 (29%) 19/65 (29%) 6/49 (12%) | |ADJUSTED (b) | 13.3% 7.1% 15.2% 63.8% | 42.4% 53.2% 52.0% 50.2% | |TERMINAL (d) | 4/36 (11%) 0/8 (0%) 1/11 (9%) 1/2 (50%) | 15/39 (38%) 5/13 (38%) 8/22 (36%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 659 646 605 521 | 550 495 524 402 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.026 * P=0.629N P=0.441 P=0.015 * | P=0.049 * P=0.146 P=0.084 P=0.086 | |INCIDENTAL TUMOR | P=0.393 P=0.282N P=0.477N P=0.489 | P=0.128N P=0.560N P=0.413N P=0.233N | |LOGISTIC REGRESSION | P=0.289 P=0.434N P=0.512N P=0.343 | P=0.149N P=0.588 P=0.488N P=0.197N | |COCHRAN-ARMITAGE | P=0.339N | P=0.005N** | |FISHER EXACT | P=0.209N P=0.229N P=0.346N | P=0.293N P=0.259N P=0.004N** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 1/34 (3%) 3/63 (5%) 3/50 (6%) | 18/49 (37%) 10/35 (29%) 20/65 (31%) 6/49 (12%) | |ADJUSTED (b) | 13.3% 7.1% 15.2% 63.8% | 42.4% 53.2% 53.3% 50.2% | |TERMINAL (d) | 4/36 (11%) 0/8 (0%) 1/11 (9%) 1/2 (50%) | 15/39 (38%) 5/13 (38%) 8/22 (36%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 659 646 605 521 | 550 495 524 402 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.026 * P=0.629N P=0.441 P=0.015 * | P=0.041 * P=0.146 P=0.059 P=0.086 | |INCIDENTAL TUMOR | P=0.393 P=0.282N P=0.477N P=0.489 | P=0.116N P=0.560N P=0.431N P=0.233N | |LOGISTIC REGRESSION | P=0.289 P=0.434N P=0.512N P=0.343 | P=0.161N P=0.588 P=0.560N P=0.197N | |COCHRAN-ARMITAGE | P=0.339N | P=0.005N** | |FISHER EXACT | P=0.209N P=0.229N P=0.346N | P=0.293N P=0.319N P=0.004N** | |=================================================================================================================================| | | |Salivary Glands | | Schwannoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 3/65 (5%) 0/50 (0%) | 0/50 (0%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.8% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 534 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.392 (e) P=0.152 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.484N (e) P=0.505 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.654 (e) P=0.214 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.576 | (e) | |FISHER EXACT | (e) P=0.177 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 8/35 (23%) 23/65 (35%) 26/50 (52%) | 1/50 (2%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.1% 53.6% 85.0% 100.0% | 2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/37 (3%) 2/8 (25%) 8/11 (73%) 2/2 (100%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 659 632 460 408 | 664 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.525N P=0.742N P=0.605N P=0.934N | |INCIDENTAL TUMOR | P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** | P=0.267N P=0.500N P=0.343N P=0.500N | |LOGISTIC REGRESSION | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** | P=0.396N P=0.640N P=0.507N P=0.760N | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.286N | |FISHER EXACT | P=0.010 * P<0.001 ** P<0.001 ** | P=0.588N P=0.435N P=0.500N | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/35 (6%) 4/65 (6%) 10/50 (20%) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 13.3% 16.0% 100.0% | 0.0% 0.0% 4.5% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 2/2 (100%) | 0/40 (0%) 0/13 (0%) 1/22 (5%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 646 637 551 | --- --- 682 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.063 P=0.018 * P<0.001 ** | P=0.473 (e) P=0.381 (e) | |INCIDENTAL TUMOR | P<0.001 ** P=0.435 P=0.390 P=0.001 ** | P=0.473 (e) P=0.381 (e) | |LOGISTIC REGRESSION | P<0.001 ** P=0.122 P=0.065 P<0.001 ** | P=0.473 (e) P=0.381 (e) | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.714 | |FISHER EXACT | P=0.167 P=0.098 P<0.001 ** | (e) P=0.565 (e) | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/35 (3%) 7/65 (11%) 2/50 (4%) | 2/50 (4%) 1/35 (3%) 3/65 (5%) 0/50 (0%) | |ADJUSTED (b) | 5.4% 5.9% 30.2% 25.0% | 4.7% 4.8% 8.6% 0.0% | |TERMINAL (d) | 2/37 (5%) 0/8 (0%) 1/11 (9%) 0/2 (0%) | 1/40 (3%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 626 575 645 | 664 622 616 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.004 ** P=0.581 P=0.006 ** P=0.036 * | P=0.590 P=0.647 P=0.346 P=0.793N | |INCIDENTAL TUMOR | P=0.336 P=0.728N P=0.220 P=0.463 | P=0.083N P=0.477N P=0.487N P=0.437N | |LOGISTIC REGRESSION | P=0.071 P=0.740 P=0.065 P=0.159 | P=0.379N P=0.694N P=0.535 P=0.610N | |COCHRAN-ARMITAGE | P=0.493 | P=0.202N | |FISHER EXACT | P=0.633N P=0.162 P=0.691N | P=0.633N P=0.623 P=0.247N | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/35 (3%) 7/65 (11%) 13/50 (26%) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 4.3% 31.6% 77.5% | 0.0% 0.0% 3.8% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 2/11 (18%) 1/2 (50%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 591 460 539 | --- --- 666 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.380 P<0.001 ** P<0.001 ** | P=0.479 (e) P=0.400 (e) | |INCIDENTAL TUMOR | P<0.001 ** P=0.690 P=0.031 * P=0.004 ** | P=0.733 (e) P=0.657 (e) | |LOGISTIC REGRESSION | P<0.001 ** P=0.461 P=0.018 * P<0.001 ** | P=0.595 (e) P=0.487 (e) | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.714 | |FISHER EXACT | P=0.412 P=0.016 * P<0.001 ** | (e) P=0.565 (e) | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/35 (11%) 11/65 (17%) 19/50 (38%) | 0/50 (0%) 2/35 (6%) 6/65 (9%) 5/50 (10%) | |ADJUSTED (b) | 5.4% 23.6% 47.2% 87.1% | 0.0% 11.0% 24.5% 38.9% | |TERMINAL (d) | 2/37 (5%) 1/8 (13%) 3/11 (27%) 1/2 (50%) | 0/40 (0%) 1/13 (8%) 4/22 (18%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 578 460 460 | --- 535 666 607 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.034 * P<0.001 ** P<0.001 ** | P<0.001 ** P=0.087 P=0.002 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.206 P=0.023 * P<0.001 ** | P=0.005 ** P=0.225 P=0.008 ** P=0.170 | |LOGISTIC REGRESSION | P<0.001 ** P=0.146 P=0.011 * P<0.001 ** | P=0.001 ** P=0.199 P=0.004 ** P=0.003 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.035 * | |FISHER EXACT | P=0.187 P=0.027 * P<0.001 ** | P=0.167 P=0.029 * P=0.028 * | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/35 (9%) 5/65 (8%) 8/50 (16%) | 0/50 (0%) 2/35 (6%) 5/65 (8%) 5/50 (10%) | |ADJUSTED (b) | 5.4% 20.2% 28.9% 72.3% | 0.0% 11.0% 21.5% 38.9% | |TERMINAL (d) | 2/37 (5%) 1/8 (13%) 2/11 (18%) 1/2 (50%) | 0/40 (0%) 1/13 (8%) 4/22 (18%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 578 617 460 | --- 535 673 607 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.087 P=0.018 * P<0.001 ** | P<0.001 ** P=0.087 P=0.005 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.002 ** P=0.279 P=0.148 P=0.042 * | P=0.005 ** P=0.225 P=0.011 * P=0.170 | |LOGISTIC REGRESSION | P=0.001 ** P=0.258 P=0.107 P=0.005 ** | P=0.001 ** P=0.199 P=0.007 ** P=0.003 ** | |COCHRAN-ARMITAGE | P=0.030 * | P=0.032 * | |FISHER EXACT | P=0.334 P=0.341 P=0.046 * | P=0.167 P=0.054 P=0.028 * | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 9/35 (26%) 27/65 (42%) 28/50 (56%) | 1/50 (2%) 0/35 (0%) 1/65 (2%) 0/50 (0%) | |ADJUSTED (b) | 5.1% 57.8% 87.5% 100.0% | 2.3% 0.0% 4.5% 0.0% | |TERMINAL (d) | 1/37 (3%) 2/8 (25%) 8/11 (73%) 2/2 (100%) | 0/40 (0%) 0/13 (0%) 1/22 (5%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 659 632 460 408 | 664 --- 682 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P=0.708 P=0.742N P=0.630 P=0.934N | |INCIDENTAL TUMOR | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** | P=0.562N P=0.500N P=0.754N P=0.500N | |LOGISTIC REGRESSION | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** | P=0.664N P=0.640N P=0.728 P=0.760N | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.376N | |FISHER EXACT | P=0.005 ** P<0.001 ** P<0.001 ** | P=0.588N P=0.683N P=0.500N | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 14/35 (40%) 34/65 (52%) 32/50 (64%) | 2/50 (4%) 3/35 (9%) 10/65 (15%) 5/50 (10%) | |ADJUSTED (b) | 15.7% 71.1% 90.6% 100.0% | 4.7% 15.2% 34.8% 38.9% | |TERMINAL (d) | 5/37 (14%) 3/8 (38%) 8/11 (73%) 2/2 (100%) | 1/40 (3%) 1/13 (8%) 5/22 (23%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 659 578 460 408 | 664 535 616 607 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.135 P=0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** | P=0.094 P=0.545 P=0.026 * P=0.419 | |LOGISTIC REGRESSION | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** | P=0.010 ** P=0.347 P=0.007 ** P=0.729 | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.188 | |FISHER EXACT | P=0.003 ** P<0.001 ** P<0.001 ** | P=0.334 P=0.043 * P=0.218 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Skin: Sebaceous Gland | | Carcinoma, Basal Cell Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/35 (3%) 7/65 (11%) 3/50 (6%) | 0/50 (0%) 1/35 (3%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 12.5% 33.2% 44.4% | 0.0% 4.5% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 1/8 (13%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 680 (T) 633 561 | --- 579 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.200 P<0.001 ** P=0.001 ** | P=0.628N P=0.353 (e) (e) | |INCIDENTAL TUMOR | P=0.082 P=0.200 P=0.173 P=0.296 | P=0.335N P=0.773 (e) (e) | |LOGISTIC REGRESSION | P=0.002 ** P=0.200 P=0.004 ** P=0.026 * | P=0.509N P=0.485 (e) (e) | |COCHRAN-ARMITAGE | P=0.105 | P=0.549N | |FISHER EXACT | P=0.412 P=0.016 * P=0.121 | P=0.412 (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/35 (6%) 5/65 (8%) 3/50 (6%) | 3/50 (6%) 0/35 (0%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.4% 25.0% 22.7% 14.5% | 6.8% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/37 (5%) 2/8 (25%) 1/11 (9%) 0/2 (0%) | 1/40 (3%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 680 (T) 623 317 | 292 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P=0.143 P=0.033 * P=0.054 | P=0.105N P=0.305N P=0.175N P=0.390N | |INCIDENTAL TUMOR | P=0.113 P=0.143 P=0.330 P=0.400 | P=0.019N* P=0.355N P=0.105N P=0.102N | |LOGISTIC REGRESSION | P=0.208 P=0.143 P=0.152 P=0.550 | P=0.011N* P=0.111N P=0.027N* P=0.028N* | |COCHRAN-ARMITAGE | P=0.412 | P=0.038N* | |FISHER EXACT | P=0.547 P=0.341 P=0.500 | P=0.198N P=0.079N P=0.121N | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibroma or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/35 (6%) 5/65 (8%) 3/50 (6%) | 3/50 (6%) 1/35 (3%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.4% 25.0% 22.7% 14.5% | 6.8% 5.6% 0.0% 0.0% | |TERMINAL (d) | 2/37 (5%) 2/8 (25%) 1/11 (9%) 0/2 (0%) | 1/40 (3%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 680 (T) 623 317 | 292 646 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P=0.143 P=0.033 * P=0.054 | P=0.128N P=0.637N P=0.175N P=0.390N | |INCIDENTAL TUMOR | P=0.113 P=0.143 P=0.330 P=0.400 | P=0.017N* P=0.626N P=0.105N P=0.102N | |LOGISTIC REGRESSION | P=0.208 P=0.143 P=0.152 P=0.550 | P=0.013N* P=0.306N P=0.027N* P=0.028N* | |COCHRAN-ARMITAGE | P=0.412 | P=0.034N* | |FISHER EXACT | P=0.547 P=0.341 P=0.500 | P=0.453N P=0.079N P=0.121N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/35 (9%) 6/65 (9%) 4/50 (8%) | 4/50 (8%) 1/35 (3%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.4% 28.4% 26.3% 26.7% | 9.2% 5.6% 0.0% 0.0% | |TERMINAL (d) | 2/37 (5%) 2/8 (25%) 1/11 (9%) 0/2 (0%) | 2/40 (5%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 592 623 317 | 292 646 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.050 * P=0.014 * P=0.008 ** | P=0.084N P=0.528N P=0.118N P=0.350N | |INCIDENTAL TUMOR | P=0.099 P=0.108 P=0.270 P=0.283 | P=0.011N* P=0.504N P=0.072N P=0.097N | |LOGISTIC REGRESSION | P=0.110 P=0.177 P=0.090 P=0.306 | P=0.006N** P=0.196N P=0.013N* P=0.019N* | |COCHRAN-ARMITAGE | P=0.315 | P=0.014N* | |FISHER EXACT | P=0.334 P=0.238 P=0.339 | P=0.310N P=0.033N* P=0.059N | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 48/50 (96%) 32/35 (91%) 61/65 (94%) 43/50 (86%) | | |ADJUSTED (b) | 100.0% 100.0% 98.4% 100.0% | | |TERMINAL (d) | 37/37 (100%) 8/8 (100%) 10/11 (91%) 2/2 (100%) | | |FIRST INCIDENCE (DAYS) | 445 421 372 317 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | | |INCIDENTAL TUMOR | P=0.422N P=0.602N P=0.158N P=0.565N | | |LOGISTIC REGRESSION | P=0.352 P=0.797N P=0.616N P=0.595 | | |COCHRAN-ARMITAGE | P=0.059N | | |FISHER EXACT | P=0.334N P=0.471N P=0.080N | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/35 (23%) 7/65 (11%) 4/50 (8%) | 10/49 (20%) 3/35 (9%) 4/65 (6%) 0/50 (0%) | |ADJUSTED (b) | 12.7% 48.2% 24.5% 47.9% | 24.1% 18.6% 14.7% 0.0% | |TERMINAL (d) | 4/37 (11%) 2/8 (25%) 1/11 (9%) 0/2 (0%) | 8/39 (21%) 1/13 (8%) 1/22 (5%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 445 578 460 505 | 659 647 659 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.026 * P=0.002 ** P=0.100 P=0.032 * | P=0.178N P=0.565N P=0.348N P=0.313N | |INCIDENTAL TUMOR | P=0.311N P=0.140 P=0.610 P=0.674N | P=0.012N* P=0.302N P=0.087N P=0.108N | |LOGISTIC REGRESSION | P=0.493N P=0.061 P=0.598 P=0.567 | P=0.031N* P=0.375N P=0.150N P=0.165N | |COCHRAN-ARMITAGE | P=0.239N | P<0.001N** | |FISHER EXACT | P=0.095 P=0.573 P=0.500N | P=0.119N P=0.023N* P<0.001N** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/35 (3%) 2/65 (3%) 1/50 (2%) | 3/49 (6%) 0/35 (0%) 3/65 (5%) 0/50 (0%) | |ADJUSTED (b) | 8.1% 5.6% 12.7% 11.1% | 7.4% 0.0% 13.6% 0.0% | |TERMINAL (d) | 3/37 (8%) 0/8 (0%) 1/11 (9%) 0/2 (0%) | 2/39 (5%) 0/13 (0%) 3/22 (14%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 624 640 624 | 669 --- 682 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.258 P=0.663 P=0.414 P=0.375 | P=0.593 P=0.375N P=0.389 P=0.677N | |INCIDENTAL TUMOR | P=0.632N P=0.622N P=0.623 P=0.769 | P=0.573N P=0.262N P=0.497 P=0.386N | |LOGISTIC REGRESSION | P=0.566 P=0.627N P=0.642 P=0.673 | P=0.645N P=0.322N P=0.463 P=0.559N | |COCHRAN-ARMITAGE | P=0.233N | P=0.127N | |FISHER EXACT | P=0.453N P=0.377N P=0.309N | P=0.193N P=0.519N P=0.117N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 9/35 (26%) 9/65 (14%) 5/50 (10%) | 11/49 (22%) 3/35 (9%) 7/65 (11%) 0/50 (0%) | |ADJUSTED (b) | 20.6% 51.1% 34.7% 53.7% | 26.6% 18.6% 26.9% 0.0% | |TERMINAL (d) | 7/37 (19%) 2/8 (25%) 2/11 (18%) 0/2 (0%) | 9/39 (23%) 1/13 (8%) 4/22 (18%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 445 578 460 505 | 659 647 659 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.014 * P=0.004 ** P=0.065 P=0.012 * | P=0.352N P=0.498N P=0.525 P=0.282N | |INCIDENTAL TUMOR | P=0.325N P=0.206 P=0.539 P=0.667 | P=0.054N P=0.251N P=0.363N P=0.097N | |LOGISTIC REGRESSION | P=0.478N P=0.115 P=0.541N P=0.562 | P=0.116N P=0.313N P=0.449N P=0.148N | |COCHRAN-ARMITAGE | P=0.127N | P<0.001N** | |FISHER EXACT | P=0.204 P=0.474N P=0.277N | P=0.080N P=0.076N P<0.001N** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/35 (11%) 1/65 (2%) 0/50 (0%) | 0/49 (0%) 1/35 (3%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 32.4% 4.5% 0.0% | 0.0% 3.1% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 2/8 (25%) 0/11 (0%) 0/2 (0%) | 0/39 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 583 646 --- | --- 506 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.481 P=0.002 ** P=0.381 (e) | P=0.607N P=0.423 (e) (e) | |INCIDENTAL TUMOR | P=0.418N P=0.018 * P=0.757 (e) | P=0.344N P=0.795 (e) (e) | |LOGISTIC REGRESSION | P=0.494N P=0.015 * P=0.512 (e) | P=0.416N P=0.472 (e) (e) | |COCHRAN-ARMITAGE | P=0.258N | P=0.547N | |FISHER EXACT | P=0.026 * P=0.565 (e) | P=0.417 (e) (e) | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 3/65 (5%) 0/50 (0%) | 0/49 (0%) 0/35 (0%) 0/65 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 19.5% 0.0% | 0.0% 0.0% 0.0% 12.5% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 2/11 (18%) 0/2 (0%) | 0/39 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 460 --- | --- --- --- 646 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.168 (e) P=0.027 * (e) | P=0.057 (e) (e) P=0.165 | |INCIDENTAL TUMOR | P=0.328 (e) P=0.040 * (e) | P=0.180 (e) (e) P=0.500 | |LOGISTIC REGRESSION | P=0.531 (e) P=0.182 (e) | P=0.121 (e) (e) P=0.350 | |COCHRAN-ARMITAGE | P=0.576 | P=0.212 | |FISHER EXACT | (e) P=0.177 (e) | (e) (e) P=0.505 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/35 (11%) 4/65 (6%) 0/50 (0%) | 0/49 (0%) 1/35 (3%) 0/65 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 32.4% 23.2% 0.0% | 0.0% 3.1% 0.0% 12.5% | |TERMINAL (d) | 0/37 (0%) 2/8 (25%) 2/11 (18%) 0/2 (0%) | 0/39 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 583 460 --- | --- 506 --- 646 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.172 P=0.002 ** P=0.010 ** (e) | P=0.245 P=0.423 (e) P=0.165 | |INCIDENTAL TUMOR | P=0.580 P=0.018 * P=0.038 * (e) | P=0.574 P=0.795 (e) P=0.500 | |LOGISTIC REGRESSION | P=0.571N P=0.015 * P=0.100 (e) | P=0.497 P=0.472 (e) P=0.350 | |COCHRAN-ARMITAGE | P=0.349N | P=0.435 | |FISHER EXACT | P=0.026 * P=0.098 (e) | P=0.417 (e) P=0.505 | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/35 (3%) 2/65 (3%) 0/50 (0%) | 0/50 (0%) 1/35 (3%) 3/65 (5%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 2.9% 5.1% 0.0% | 0.0% 7.7% 6.7% 34.1% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 1/13 (8%) 0/22 (0%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- 293 502 --- | --- 682 (T) 432 585 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.597 P=0.429 P=0.226 (e) | P=0.003 ** P=0.277 P=0.118 P=0.003 ** | |INCIDENTAL TUMOR | P=0.321N P=0.500 P=0.608 (e) | P=0.147 P=0.277 P=0.622 P=0.114 | |LOGISTIC REGRESSION | P=0.334N P=0.500 P=0.344 (e) | P=0.057 P=0.277 P=0.236 P=0.031 * | |COCHRAN-ARMITAGE | P=0.583N | P=0.085 | |FISHER EXACT | P=0.412 P=0.317 (e) | P=0.412 P=0.177 P=0.121 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/35 (3%) 3/65 (5%) 2/50 (4%) | 2/50 (4%) 2/35 (6%) 4/65 (6%) 7/50 (14%) | |ADJUSTED (b) | 0.0% 2.9% 13.0% 8.9% | 5.0% 11.2% 10.9% 60.0% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 2/40 (5%) 1/13 (8%) 1/22 (5%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | --- 293 502 551 | 682 (T) 558 432 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.035 * P=0.429 P=0.059 P=0.104 | P<0.001 ** P=0.322 P=0.209 P<0.001 ** | |INCIDENTAL TUMOR | P=0.428 P=0.500 P=0.460 P=0.516 | P=0.032 * P=0.517 P=0.594 P=0.027 * | |LOGISTIC REGRESSION | P=0.326 P=0.500 P=0.185 P=0.248 | P=0.033 * P=0.520 P=0.483 P=0.054 | |COCHRAN-ARMITAGE | P=0.194 | P=0.039 * | |FISHER EXACT | P=0.412 P=0.177 P=0.247 | P=0.547 P=0.471 P=0.080 | |=================================================================================================================================| | | |Tongue | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/35 (0%) 1/65 (2%) 2/50 (4%) | 2/50 (4%) 1/35 (3%) 1/65 (2%) 4/50 (8%) | |ADJUSTED (b) | 0.0% 0.0% 8.3% 8.9% | 5.0% 3.8% 4.5% 31.6% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 2/40 (5%) 0/13 (0%) 1/22 (5%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | --- --- 679 551 | 682 (T) 558 682 (T) 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006 ** (e) P=0.277 P=0.104 | P=0.015 * P=0.676 P=0.703N P=0.022 * | |INCIDENTAL TUMOR | P=0.097 (e) P=0.757 P=0.516 | P=0.114 P=0.614N P=0.703N P=0.228 | |LOGISTIC REGRESSION | P=0.054 (e) P=0.303 P=0.248 | P=0.231 P=0.631N P=0.703N P=0.426 | |COCHRAN-ARMITAGE | P=0.081 | P=0.201 | |FISHER EXACT | (e) P=0.565 P=0.247 | P=0.633N P=0.402N P=0.339 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Uterus | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 0/35 (0%) 0/65 (0%) 3/50 (6%) | |ADJUSTED (b) | | 2.5% 0.0% 0.0% 19.1% | |TERMINAL (d) | | 1/40 (3%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | | 682 (T) --- --- 607 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.008 ** P=0.723N P=0.619N P=0.018 * | |INCIDENTAL TUMOR | | P=0.162 P=0.723N P=0.619N P=0.707 | |LOGISTIC REGRESSION | | P=0.042 * P=0.723N P=0.619N P=0.132 | |COCHRAN-ARMITAGE | | P=0.101 | |FISHER EXACT | | P=0.588N P=0.435N P=0.309 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 5/50 (10%) 8/35 (23%) 12/65 (18%) 5/50 (10%) | |ADJUSTED (b) | | 12.5% 41.5% 39.4% 32.4% | |TERMINAL (d) | | 5/40 (13%) 4/13 (31%) 7/22 (32%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | | 682 (T) 540 432 453 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.007 ** P=0.005 ** P=0.005 ** P=0.034 * | |INCIDENTAL TUMOR | | P=0.316 P=0.068 P=0.038 * P=0.340 | |LOGISTIC REGRESSION | | P=0.514 P=0.056 P=0.078 P=0.630N | |COCHRAN-ARMITAGE | | P=0.408N | |FISHER EXACT | | P=0.095 P=0.158 P=0.630N | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 27 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 1/50 (2%) 0/35 (0%) 1/65 (2%) 2/50 (4%) | |ADJUSTED (b) | | 2.1% 0.0% 4.5% 6.9% | |TERMINAL (d) | | 0/40 (0%) 0/13 (0%) 1/22 (5%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | | 502 --- 682 (T) 408 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.117 P=0.581N P=0.711 P=0.361 | |INCIDENTAL TUMOR | | P=0.434 P=0.205N P=0.682N P=0.343N | |LOGISTIC REGRESSION | | P=0.434 P=0.533N P=0.658N P=0.712N | |COCHRAN-ARMITAGE | | P=0.279 | |FISHER EXACT | | P=0.588N P=0.683N P=0.500 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 6/50 (12%) 8/35 (23%) 13/65 (20%) 7/50 (14%) | |ADJUSTED (b) | | 14.3% 41.5% 43.5% 37.1% | |TERMINAL (d) | | 5/40 (13%) 4/13 (31%) 8/22 (36%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | | 502 540 432 408 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.002 ** P=0.014 * P=0.006 ** P=0.021 * | |INCIDENTAL TUMOR | | P=0.250 P=0.190 P=0.057 P=0.642 | |LOGISTIC REGRESSION | | P=0.453 P=0.148 P=0.115 P=0.542N | |COCHRAN-ARMITAGE | | P=0.549N | |FISHER EXACT | | P=0.151 P=0.187 P=0.500 | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 28 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/35 (6%) 2/65 (3%) 4/50 (8%) | 0/50 (0%) 1/35 (3%) 5/65 (8%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 21.3% 5.0% 22.2% | 0.0% 3.0% 15.4% 13.1% | |TERMINAL (d) | 0/37 (0%) 1/8 (13%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 1/22 (5%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 660 577 551 | --- 495 432 547 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.023 * P=0.228 P=0.004 ** | P=0.006 ** P=0.421 P=0.016 * P=0.031 * | |INCIDENTAL TUMOR | P=0.045 * P=0.149 P=0.678 P=0.282 | P=0.284 P=0.795 P=0.136 P=0.672 | |LOGISTIC REGRESSION | P=0.024 * P=0.054 P=0.316 P=0.041 * | P=0.118 P=0.462 P=0.067 P=0.122 | |COCHRAN-ARMITAGE | P=0.057 | P=0.097 | |FISHER EXACT | P=0.167 P=0.317 P=0.059 | P=0.412 P=0.054 P=0.121 | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/35 (9%) 8/65 (12%) 17/50 (34%) | 0/50 (0%) 4/35 (11%) 7/65 (11%) 14/50 (28%) | |ADJUSTED (b) | 2.2% 13.3% 22.5% 46.3% | 0.0% 14.5% 17.0% 60.2% | |TERMINAL (d) | 0/37 (0%) 0/8 (0%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 1/22 (5%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 501 583 323 372 | --- 465 432 296 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.128 P=0.014 * P<0.001 ** | P<0.001 ** P=0.017 * P=0.007 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.016 * P=0.631 P=0.262 P=0.172 | P=0.006 ** P=0.247 P=0.140 P=0.013 * | |LOGISTIC REGRESSION | P=0.006 ** P=0.247 P=0.083 P=0.088 | P=0.007 ** P=0.056 P=0.037 * P=0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.187 P=0.040 * P<0.001 ** | P=0.026 * P=0.016 * P<0.001 ** | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 29 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/35 (14%) 10/65 (15%) 20/50 (40%) | 0/50 (0%) 4/35 (11%) 11/65 (17%) 17/50 (34%) | |ADJUSTED (b) | 2.2% 31.7% 26.4% 54.0% | 0.0% 14.5% 28.8% 65.4% | |TERMINAL (d) | 0/37 (0%) 1/8 (13%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 2/22 (9%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 501 583 323 372 | --- 465 432 296 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.007 ** P=0.005 ** P<0.001 ** | P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.004 ** P=0.216 P=0.206 P=0.077 | P=0.001 ** P=0.247 P=0.026 * P=0.009 ** | |LOGISTIC REGRESSION | P=0.002 ** P=0.045 * P=0.037 * P=0.040 * | P<0.001 ** P=0.056 P=0.004 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.041 * P=0.014 * P<0.001 ** | P=0.026 * P=0.001 ** P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 17/50 (34%) 19/35 (54%) 28/65 (43%) 20/50 (40%) | 7/50 (14%) 13/35 (37%) 27/65 (42%) 15/50 (30%) | |ADJUSTED (b) | 39.1% 84.3% 91.6% 100.0% | 16.3% 51.0% 67.2% 83.6% | |TERMINAL (d) | 11/37 (30%) 5/8 (63%) 9/11 (82%) 2/2 (100%) | 5/40 (13%) 3/13 (23%) 11/22 (50%) 2/4 (50%) | |FIRST INCIDENCE (DAYS) | 445 544 472 452 | 624 463 449 453 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.067 P=0.187 P=0.140 P=0.372 | P=0.115 P=0.137 P=0.003 ** P=0.076 | |LOGISTIC REGRESSION | P=0.004 ** P=0.018 * P=0.053 P=0.012 * | P=0.066 P=0.025 * P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P=0.471 | P=0.089 | |FISHER EXACT | P=0.051 P=0.213 P=0.339 | P=0.014 * P=0.001 ** P=0.045 * | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 30 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/35 (9%) 2/65 (3%) 2/50 (4%) | 0/50 (0%) 1/35 (3%) 0/65 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.7% 19.3% 6.1% 7.5% | 0.0% 5.9% 0.0% 0.0% | |TERMINAL (d) | 1/37 (3%) 1/8 (13%) 0/11 (0%) 0/2 (0%) | 0/40 (0%) 0/13 (0%) 0/22 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 680 (T) 513 451 463 | --- 647 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.148 P=0.053 P=0.333 P=0.167 | P=0.815 P=0.306 (e) (e) | |INCIDENTAL TUMOR | P=0.506N P=0.174 P=0.663 P=0.631 | P=0.561N P=0.500 (e) (e) | |LOGISTIC REGRESSION | P=0.575N P=0.193 P=0.640 P=0.534 | P=0.655N P=0.410 (e) (e) | |COCHRAN-ARMITAGE | P=0.558 | P=0.549N | |FISHER EXACT | P=0.187 P=0.598 P=0.500 | P=0.412 (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 33/35 (94%) 62/65 (95%) 46/50 (92%) | 38/50 (76%) 27/35 (77%) 54/65 (83%) 33/50 (66%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 79.1% 89.3% 100.0% 100.0% | |TERMINAL (d) | 37/37 (100%) 8/8 (100%) 11/11 (100%) 2/2 (100%) | 30/40 (75%) 10/13 (77%) 22/22 (100%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 445 316 372 317 | 292 463 368 372 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.304 P=0.705 P=0.551N P=0.692 | P=0.334 P=0.485 P=0.050 P=0.459 | |LOGISTIC REGRESSION | P=0.093 P=0.623 P=0.760N P=0.249 | P=0.158 P=0.471 P=0.019 * P=0.259 | |COCHRAN-ARMITAGE | P=0.268N | P=0.144N | |FISHER EXACT | P=0.547N P=0.623N P=0.339N | P=0.558 P=0.240 P=0.189N | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 31 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.063 0.125 0.25 | CONTROL 0.063 0.125 0.25 | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 23/50 (46%) 27/35 (77%) 54/65 (83%) 45/50 (90%) | 21/50 (42%) 25/35 (71%) 56/65 (86%) 48/50 (96%) | |ADJUSTED (b) | 51.9% 89.3% 95.9% 100.0% | 45.3% 74.2% 91.4% 100.0% | |TERMINAL (d) | 16/37 (43%) 5/8 (63%) 9/11 (82%) 2/2 (100%) | 15/40 (38%) 5/13 (38%) 17/22 (77%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 445 293 323 243 | 500 463 253 296 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.063 P=0.003 ** P=0.002 ** | P<0.001 ** P=0.349 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.076 P<0.001 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.004 ** P<0.001 ** P<0.001 ** | P=0.007 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 34/35 (97%) 65/65 (100%) 48/50 (96%) | 43/50 (86%) 33/35 (94%) 64/65 (98%) 49/50 (98%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 86.0% 94.3% 100.0% 100.0% | |TERMINAL (d) | 37/37 (100%) 8/8 (100%) 11/11 (100%) 2/2 (100%) | 33/40 (83%) 11/13 (85%) 22/22 (100%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 445 293 323 243 | 292 463 253 296 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |INCIDENTAL TUMOR | P=0.286 P=0.434 P=0.362 P=0.390 | P=0.098 P=0.597 P=0.069 P=0.531 | |LOGISTIC REGRESSION | P=0.018 * P=0.334 P=0.138 P=0.022 * | P=0.010 * P=0.597 P=0.014 * P=0.071 | |COCHRAN-ARMITAGE | P=0.607 | P=0.009 ** | |FISHER EXACT | P=0.633 P=0.187 P=0.691N | P=0.196 P=0.012 * P=0.030 * | |=================================================================================================================================| DATE: 09/18/94 EXPERIMENT: 05169 TEST: 01 PAGE 32 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- C. I. DIRECT BLUE 15 TERMINAL SACRIFICE AT 98 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (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). --multipart-boundary Content-type: text/plain Range: bytes 222647-222647/222647 --multipart-boundary--