TDMS Study 05160-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: TSI Mason Research 1-CHLORO-2-PROPANOL DATE: 08/01/97 EXPERIMENT: 05160 TEST: 06 TIME: 09:06:57 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-05300 ROUTE: DOSED WATER NTP C#: 61983C PATHOLOGIST: F. VOELKER CAS: 127-00-4 Mice(B6C3F1) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial 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: TSI Mason Research 1-CHLORO-2-PROPANOL DATE: 08/01/97 EXPERIMENT: 05160 TEST: 06 TIME: 09:06:57 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-05300 ROUTE: DOSED WATER NTP C#: 61983C PATHOLOGIST: F. VOELKER CAS: 127-00-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF 1-CHLORO-2-PROPANOL =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Liver Hepatoblastoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma =============================================================== Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 5.3% 4.5% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 1/44 (2%) 2/29 (7%) 1/39 (3%) |0/32 (0%) 1/32 (3%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 543 |--- 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.151 P=0.519 P=0.171 P=0.242 |P=0.566N P=0.500 (e) (e) | |POLY 3 | P=0.164 P=0.548 P=0.251 P=0.265 |P=0.627N P=0.548 (e) (e) | |POLY 1.5 | P=0.163 P=0.531 P=0.244 P=0.255 |P=0.608N P=0.532 (e) (e) | |POLY 6 | P=0.166 P=0.564 P=0.261 P=0.275 |P=0.650N P=0.571 (e) (e) | |LOGISTIC REGRESSION| P=0.157 P=0.519 P=0.171 P=0.241 |(e) P=0.500 (e) (e) | |COCH-ARM / FISHERS | P=0.160 P=0.500 P=0.247 P=0.247 |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 8.4% 5.3% 2.3% |6.7% 2.3% 2.3% 0.0% | |TERMINAL (d) | 1/40 (3%) 4/44 (9%) 2/29 (7%) 1/39 (3%) |2/32 (6%) 1/32 (3%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |587 735 (T) 655 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.445N P=0.209 P=0.388 P=0.756 |P=0.077N P=0.310N P=0.303N P=0.128N | |POLY 3 | P=0.428N P=0.211 P=0.494 P=0.786 |P=0.089N P=0.333N P=0.341N P=0.156N | |POLY 1.5 | P=0.420N P=0.200 P=0.493 P=0.777 |P=0.085N P=0.318N P=0.330N P=0.144N | |POLY 6 | P=0.440N P=0.222 P=0.497 P=0.794 |P=0.093N P=0.354N P=0.355N P=0.171N | |LOGISTIC REGRESSION| P=0.445N P=0.209 P=0.388 P=0.756 |P=0.073N P=0.304N P=0.303N P=0.122N | |COCH-ARM / FISHERS | P=0.404N P=0.181 P=0.500 P=0.753N |P=0.073N P=0.309N P=0.309N P=0.121N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 2.6% 0.0% |4.5% 4.5% 2.3% 2.4% | |TERMINAL (d) | 1/40 (3%) 1/44 (2%) 0/29 (0%) 0/39 (0%) |1/32 (3%) 1/32 (3%) 1/36 (3%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 608 --- |657 647 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.333N P=0.740N P=0.704 P=0.505N |P=0.353N P=0.686 P=0.492N P=0.520N | |POLY 3 | P=0.339N P=0.765N P=0.774 P=0.551N |P=0.382N P=0.713 P=0.544N P=0.566N | |POLY 1.5 | P=0.330N P=0.763N P=0.767 P=0.534N |P=0.370N P=0.703N P=0.530N P=0.546N | |POLY 6 | P=0.350N P=0.768N P=0.782 P=0.572N |P=0.396N P=0.717 P=0.562N P=0.588N | |LOGISTIC REGRESSION| P=0.315N P=0.740N P=0.759 (e) |P=0.354N P=0.694 P=0.507N P=0.519N | |COCH-ARM / FISHERS | P=0.311N P=0.753N P=0.753N P=0.500N |P=0.337N P=0.691N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 1/50 (2%) |5/50 (10%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 10.5% 7.9% 2.3% |11.0% 6.7% 4.6% 2.4% | |TERMINAL (d) | 1/40 (3%) 5/44 (11%) 2/29 (7%) 1/39 (3%) |3/32 (9%) 2/32 (6%) 1/36 (3%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 608 729 (T) |587 647 655 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.414N P=0.126 P=0.212 P=0.756 |P=0.072N P=0.367N P=0.215N P=0.117N | |POLY 3 | P=0.393N P=0.125 P=0.288 P=0.786 |P=0.082N P=0.380N P=0.248N P=0.138N | |POLY 1.5 | P=0.386N P=0.117 P=0.290 P=0.777 |P=0.078N P=0.365N P=0.238N P=0.126N | |POLY 6 | P=0.404N P=0.133 P=0.286 P=0.794 |P=0.088N P=0.402N P=0.261N P=0.152N | |LOGISTIC REGRESSION| P=0.399N P=0.126 P=0.254 P=0.756 |P=0.068N P=0.356N P=0.218N P=0.110N | |COCH-ARM / FISHERS | P=0.371N P=0.102 P=0.309 P=0.753N |P=0.064N P=0.357N P=0.218N P=0.102N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 4.5% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 0/44 (0%) 0/29 (0%) 1/39 (3%) |1/32 (3%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 645 |735 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.234 P=0.481N P=0.564N P=0.494 |P=0.302N P=0.500N P=0.477N P=0.500N | |POLY 3 | P=0.244 P=0.521N P=0.627N P=0.528 |P=0.350N P=0.550N P=0.561N P=0.580N | |POLY 1.5 | P=0.244 P=0.514N P=0.586N P=0.518 |P=0.337N P=0.529N P=0.541N P=0.556N | |POLY 6 | P=0.244 P=0.530N P=0.672N P=0.538 |P=0.367N P=0.581N P=0.587N P=0.611N | |LOGISTIC REGRESSION| P=0.241 (e) (e) P=0.499 |P=0.302N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 6.6% 0.0% 5.3% 4.5% |2.2% 0.0% 2.3% 2.4% | |TERMINAL (d) | 2/40 (5%) 0/44 (0%) 1/29 (3%) 2/39 (5%) |1/32 (3%) 0/32 (0%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | 501 --- 602 729 (T) |735 (T) --- 735 (T) 734 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.596 P=0.111N P=0.609N P=0.509N |P=0.546 P=0.500N P=0.736N P=0.757N | |POLY 3 | P=0.613 P=0.119N P=0.620N P=0.532N |P=0.548 P=0.550N P=0.784 P=0.780 | |POLY 1.5 | P=0.604N P=0.119N P=0.584N P=0.521N |P=0.542 P=0.529N P=0.776 P=0.773 | |POLY 6 | P=0.608 P=0.120N P=0.657N P=0.545N |P=0.558 P=0.581N P=0.795 P=0.791 | |LOGISTIC REGRESSION| P=0.578N P=0.140N P=0.502N P=0.500N |P=0.529 (e) P=0.736N P=0.749 | |COCH-ARM / FISHERS | P=0.577N P=0.121N P=0.500N P=0.500N |P=0.539 P=0.500N P=0.753N P=0.753N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/50 (6%) 0/50 (0%) 6/50 (12%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 13.1% 6.3% 0.0% 13.3% |0.0% 2.3% 2.3% 2.4% | |TERMINAL (d) | 4/40 (10%) 3/44 (7%) 0/29 (0%) 4/39 (10%) |0/32 (0%) 1/32 (3%) 1/36 (3%) 1/32 (3%) | |FIRST INCIDENCE | 518 729 (T) --- 568 |--- 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.472 P=0.206N P=0.039N* P=0.609 |P=0.386 P=0.500 P=0.523 P=0.500 | |POLY 3 | P=0.483 P=0.231N P=0.037N* P=0.621 |P=0.386 P=0.548 P=0.549 P=0.551 | |POLY 1.5 | P=0.494 P=0.234N P=0.028N* P=0.621 |P=0.384 P=0.532 P=0.533 P=0.534 | |POLY 6 | P=0.472 P=0.230N P=0.049N* P=0.620 |P=0.392 P=0.571 P=0.572 P=0.575 | |LOGISTIC REGRESSION| P=0.511 P=0.262N P=0.017N* P=0.619N |(e) P=0.500 P=0.523 P=0.500 | |COCH-ARM / FISHERS | P=0.518 P=0.243N P=0.013N* P=0.620N |P=0.384 P=0.500 P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 35/50 (70%) 34/50 (68%) 30/50 (60%) |40/50 (80%) 39/50 (78%) 42/50 (84%) 40/50 (80%) | |POLY-3 ADJUSTED (b)| 76.0% 72.9% 79.6% 65.1% |85.2% 82.3% 92.4% 88.7% | |TERMINAL (d) | 32/40 (80%) 33/44 (75%) 23/29 (79%) 25/39 (64%) |29/32 (91%) 27/32 (84%) 36/36 (100%) 29/32 (91%) | |FIRST INCIDENCE | 464 645 377 556 |587 449 543 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.356N P=0.306N P=0.055 P=0.253N |P=0.446 P=0.533N P=0.468N P=0.498 | |POLY 3 | P=0.151N P=0.460N P=0.451 P=0.176N |P=0.237 P=0.465N P=0.211 P=0.430 | |POLY 1.5 | P=0.155N P=0.503N P=0.479 P=0.189N |P=0.271 P=0.428N P=0.270 P=0.461 | |POLY 6 | P=0.144N P=0.416N P=0.436 P=0.161N |P=0.213 P=0.534N P=0.134 P=0.405 | |LOGISTIC REGRESSION| P=0.195N P=0.378N P=0.304 P=0.193N |P=0.183 P=0.473N P=0.244 P=0.354 | |COCH-ARM / FISHERS | P=0.143N P=0.586N P=0.500N P=0.201N |P=0.488 P=0.500N P=0.398 P=0.598N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 6/50 (12%) 6/50 (12%) 8/50 (16%) |6/50 (12%) 9/50 (18%) 9/50 (18%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 29.0% 12.2% 15.0% 17.7% |13.4% 19.4% 20.3% 23.4% | |TERMINAL (d) | 12/40 (30%) 4/44 (9%) 1/29 (3%) 4/39 (10%) |4/32 (13%) 3/32 (9%) 5/36 (14%) 7/32 (22%) | |FIRST INCIDENCE | 646 335 458 617 |726 575 645 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.261N P=0.044N* P=0.204N P=0.187N |P=0.188 P=0.287 P=0.334 P=0.199 | |POLY 3 | P=0.228N P=0.038N* P=0.109N P=0.159N |P=0.168 P=0.326 P=0.294 P=0.186 | |POLY 1.5 | P=0.219N P=0.044N* P=0.096N P=0.162N |P=0.173 P=0.318 P=0.289 P=0.189 | |POLY 6 | P=0.236N P=0.034N* P=0.123N P=0.157N |P=0.166 P=0.339 P=0.305 P=0.188 | |LOGISTIC REGRESSION| P=0.189N P=0.070N P=0.086N P=0.165N |P=0.185 P=0.285 P=0.270 P=0.173 | |COCH-ARM / FISHERS | P=0.192N P=0.062N P=0.062N P=0.163N |P=0.204 P=0.288 P=0.288 P=0.207 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 9/50 (18%) 6/50 (12%) 13/50 (26%) |6/50 (12%) 10/50 (20%) 10/50 (20%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 39.0% 18.3% 15.0% 28.4% |13.4% 21.5% 22.5% 23.4% | |TERMINAL (d) | 15/40 (38%) 7/44 (16%) 1/29 (3%) 8/39 (21%) |4/32 (13%) 4/32 (13%) 6/36 (17%) 7/32 (22%) | |FIRST INCIDENCE | 518 335 458 568 |726 575 645 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.318N P=0.024N* P=0.042N* P=0.227N |P=0.211 P=0.210 P=0.254 P=0.199 | |POLY 3 | P=0.280N P=0.020N* P=0.012N* P=0.199N |P=0.186 P=0.239 P=0.210 P=0.186 | |POLY 1.5 | P=0.267N P=0.023N* P=0.009N** P=0.199N |P=0.192 P=0.232 P=0.206 P=0.189 | |POLY 6 | P=0.291N P=0.019N* P=0.017N* P=0.200N |P=0.184 P=0.250 P=0.219 P=0.188 | |LOGISTIC REGRESSION| P=0.229N P=0.044N* P=0.007N** P=0.196N |P=0.204 P=0.206 P=0.190 P=0.173 | |COCH-ARM / FISHERS | P=0.230N P=0.035N* P=0.005N** P=0.194N |P=0.228 P=0.207 P=0.207 P=0.207 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/50 (78%) 38/50 (76%) 37/50 (74%) 32/50 (64%) |41/50 (82%) 41/50 (82%) 43/50 (86%) 42/50 (84%) | |POLY-3 ADJUSTED (b)| 84.2% 76.5% 83.8% 69.0% |87.3% 85.1% 93.9% 92.7% | |TERMINAL (d) | 35/40 (88%) 34/44 (77%) 23/29 (79%) 26/39 (67%) |29/32 (91%) 27/32 (84%) 36/36 (100%) 30/32 (94%) | |FIRST INCIDENCE | 464 335 377 556 |587 449 543 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250N P=0.217N P=0.064 P=0.145N |P=0.384 P=0.534 P=0.471N P=0.419 | |POLY 3 | P=0.068N P=0.247N P=0.608N P=0.064N |P=0.140 P=0.503N P=0.219 P=0.301 | |POLY 1.5 | P=0.068N P=0.318N P=0.610N P=0.074N |P=0.173 P=0.494N P=0.268 P=0.330 | |POLY 6 | P=0.064N P=0.198N P=0.584N P=0.055N |P=0.121 P=0.530N P=0.154 P=0.287 | |LOGISTIC REGRESSION| P=0.080N P=0.373N P=0.401 P=0.081N |P=0.115 P=0.560N P=0.235 P=0.222 | |COCH-ARM / FISHERS | P=0.059N P=0.500N P=0.408N P=0.093N |P=0.411 P=0.602N P=0.393 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 40/50 (80%) 39/50 (78%) 37/50 (74%) 36/50 (72%) |41/50 (82%) 41/50 (82%) 43/50 (86%) 42/50 (84%) | |POLY-3 ADJUSTED (b)| 85.3% 78.6% 83.8% 77.6% |87.3% 85.1% 93.9% 92.7% | |TERMINAL (d) | 35/40 (88%) 35/44 (80%) 23/29 (79%) 30/39 (77%) |29/32 (91%) 27/32 (84%) 36/36 (100%) 30/32 (94%) | |FIRST INCIDENCE | 464 335 377 556 |587 449 543 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.474N P=0.214N P=0.093 P=0.325N |P=0.384 P=0.534 P=0.471N P=0.419 | |POLY 3 | P=0.271N P=0.277N P=0.549N P=0.245N |P=0.140 P=0.503N P=0.219 P=0.301 | |POLY 1.5 | P=0.251N P=0.335N P=0.533N P=0.247N |P=0.173 P=0.494N P=0.268 P=0.330 | |POLY 6 | P=0.280N P=0.242N P=0.548N P=0.242N |P=0.121 P=0.530N P=0.154 P=0.287 | |LOGISTIC REGRESSION| P=0.243N P=0.389N P=0.524 P=0.229N |P=0.115 P=0.560N P=0.235 P=0.222 | |COCH-ARM / FISHERS | P=0.185N P=0.500N P=0.318N P=0.241N |P=0.411 P=0.602N P=0.393 P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 8/50 (16%) 4/50 (8%) 5/50 (10%) |4/50 (8%) 1/50 (2%) 4/50 (8%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 26.3% 16.8% 10.5% 11.2% |9.0% 2.3% 9.1% 9.5% | |TERMINAL (d) | 10/40 (25%) 8/44 (18%) 3/29 (10%) 4/39 (10%) |3/32 (9%) 1/32 (3%) 2/36 (6%) 2/32 (6%) | |FIRST INCIDENCE | 220 729 (T) 511 568 |733 735 (T) 645 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.051N P=0.167N P=0.101N P=0.065N |P=0.398 P=0.183N P=0.608N P=0.640N | |POLY 3 | P=0.040N* P=0.199N P=0.067N P=0.059N |P=0.388 P=0.195N P=0.653 P=0.634 | |POLY 1.5 | P=0.037N* P=0.210N P=0.053N P=0.058N |P=0.387 P=0.186N P=0.647 P=0.634 | |POLY 6 | P=0.043N* P=0.189N P=0.087N P=0.061N |P=0.393 P=0.210N P=0.661 P=0.637 | |LOGISTIC REGRESSION| P=0.035N* P=0.220N P=0.038N* P=0.055N |P=0.383 P=0.194N P=0.631 P=0.623 | |COCH-ARM / FISHERS | P=0.031N* P=0.227N P=0.027N* P=0.054N |P=0.404 P=0.181N P=0.643N P=0.643N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 5/50 (10%) 4/50 (8%) |5/50 (10%) 1/50 (2%) 2/50 (4%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 9.0% 6.3% 13.0% 8.9% |10.8% 2.2% 4.6% 7.1% | |TERMINAL (d) | 4/40 (10%) 2/44 (5%) 2/29 (7%) 3/39 (8%) |1/32 (3%) 0/32 (0%) 2/36 (6%) 2/32 (6%) | |FIRST INCIDENCE | 729 (T) 710 519 543 |465 710 735 (T) 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.450 P=0.449N P=0.328 P=0.634 |P=0.411N P=0.120N P=0.208N P=0.382N | |POLY 3 | P=0.487 P=0.477N P=0.438 P=0.656N |P=0.435N P=0.120N P=0.259N P=0.429N | |POLY 1.5 | P=0.490 P=0.484N P=0.451 P=0.652N |P=0.427N P=0.110N P=0.245N P=0.407N | |POLY 6 | P=0.482 P=0.470N P=0.424 P=0.663N |P=0.444N P=0.133N P=0.278N P=0.454N | |LOGISTIC REGRESSION| P=0.486 P=0.451N P=0.424 P=0.641 |P=0.368N P=0.122N P=0.206N P=0.318N | |COCH-ARM / FISHERS | P=0.500 P=0.500N P=0.500 P=0.643N |P=0.397N P=0.102N P=0.218N P=0.357N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 11/50 (22%) 9/50 (18%) 9/50 (18%) |9/50 (18%) 2/50 (4%) 5/50 (10%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 35.1% 23.1% 23.0% 19.8% |19.4% 4.5% 11.4% 14.2% | |TERMINAL (d) | 14/40 (35%) 10/44 (23%) 5/29 (17%) 7/39 (18%) |4/32 (13%) 1/32 (3%) 3/36 (8%) 4/32 (13%) | |FIRST INCIDENCE | 220 710 511 543 |465 710 645 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.123N P=0.123N P=0.296N P=0.098N |P=0.426N P=0.036N* P=0.182N P=0.310N | |POLY 3 | P=0.087N P=0.150N P=0.177N P=0.084N |P=0.461N P=0.032N* P=0.233N P=0.373N | |POLY 1.5 | P=0.084N P=0.163N P=0.149N P=0.085N |P=0.451N P=0.028N* P=0.220N P=0.347N | |POLY 6 | P=0.091N P=0.138N P=0.208N P=0.083N |P=0.470N P=0.038N* P=0.246N P=0.402N | |LOGISTIC REGRESSION| P=0.082N P=0.161N P=0.126N P=0.084N |P=0.416N P=0.029N* P=0.192N P=0.289N | |COCH-ARM / FISHERS | P=0.072N P=0.184N P=0.083N P=0.083N |P=0.409N P=0.026N* P=0.194N P=0.288N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 0/49 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |2.2% 0.0% 2.3% 4.8% | |TERMINAL (d) | |1/32 (3%) 0/32 (0%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | |735 (T) --- 735 (T) 642 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.235 P=0.500N P=0.736N P=0.475 | |POLY 3 | |P=0.255 P=0.550N P=0.784 P=0.515 | |POLY 1.5 | |P=0.251 P=0.531N P=0.776 P=0.508 | |POLY 6 | |P=0.262 P=0.578N P=0.795 P=0.527 | |LOGISTIC REGRESSION| |P=0.240 (e) P=0.736N P=0.495 | |COCH-ARM / FISHERS | |P=0.249 P=0.505N P=0.753N P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/49 (0%) 0/47 (0%) |6/49 (12%) 5/49 (10%) 3/47 (6%) 4/46 (9%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |13.6% 11.4% 7.3% 10.5% | |TERMINAL (d) | 0/40 (0%) 1/43 (2%) 0/29 (0%) 0/37 (0%) |5/32 (16%) 4/32 (13%) 3/35 (9%) 4/30 (13%) | |FIRST INCIDENCE | --- 729 (T) --- --- |733 695 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.587N P=0.514 (e) (e) |P=0.304N P=0.502N P=0.200N P=0.406N | |POLY 3 | P=0.606N P=0.544 (e) (e) |P=0.374N P=0.519N P=0.295N P=0.487N | |POLY 1.5 | P=0.595N P=0.527 (e) (e) |P=0.362N P=0.504N P=0.286N P=0.466N | |POLY 6 | P=0.621N P=0.560 (e) (e) |P=0.384N P=0.538N P=0.305N P=0.507N | |LOGISTIC REGRESSION| (e) P=0.514 (e) (e) |P=0.364N P=0.536N P=0.200N P=0.406N | |COCH-ARM / FISHERS | P=0.576N P=0.495 (e) (e) |P=0.318N P=0.500N P=0.264N P=0.411N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 0.0% |2.2% 6.8% 2.3% 4.8% | |TERMINAL (d) | 1/40 (3%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |1/32 (3%) 3/32 (9%) 1/36 (3%) 2/32 (6%) | |FIRST INCIDENCE | 729 (T) --- --- --- |735 (T) 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322N P=0.481N P=0.564N P=0.505N |P=0.532 P=0.304 P=0.736N P=0.500 | |POLY 3 | P=0.349N P=0.521N P=0.627N P=0.551N |P=0.513 P=0.326 P=0.784 P=0.513 | |POLY 1.5 | P=0.334N P=0.514N P=0.586N P=0.534N |P=0.515 P=0.322 P=0.776 P=0.507 | |POLY 6 | P=0.365N P=0.530N P=0.672N P=0.572N |P=0.514 P=0.331 P=0.795 P=0.523 | |LOGISTIC REGRESSION| P=0.322N (e) (e) (e) |P=0.532 P=0.304 P=0.736N P=0.500 | |COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.526 P=0.309 P=0.753N P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 0.0% |2.2% 6.8% 2.3% 4.8% | |TERMINAL (d) | 1/40 (3%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |1/32 (3%) 3/32 (9%) 1/36 (3%) 2/32 (6%) | |FIRST INCIDENCE | 729 (T) --- --- --- |735 (T) 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322N P=0.481N P=0.564N P=0.505N |P=0.532 P=0.304 P=0.736N P=0.500 | |POLY 3 | P=0.349N P=0.521N P=0.627N P=0.551N |P=0.513 P=0.326 P=0.784 P=0.513 | |POLY 1.5 | P=0.334N P=0.514N P=0.586N P=0.534N |P=0.515 P=0.322 P=0.776 P=0.507 | |POLY 6 | P=0.365N P=0.530N P=0.672N P=0.572N |P=0.514 P=0.331 P=0.795 P=0.523 | |LOGISTIC REGRESSION| P=0.322N (e) (e) (e) |P=0.532 P=0.304 P=0.736N P=0.500 | |COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.526 P=0.309 P=0.753N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 0.0% 0.0% |2.2% 4.5% 2.3% 0.0% | |TERMINAL (d) | 1/40 (3%) 1/44 (2%) 0/29 (0%) 0/39 (0%) |1/32 (3%) 0/32 (0%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |735 (T) 691 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.256N P=0.740N P=0.564N P=0.505N |P=0.259N P=0.503 P=0.736N P=0.500N | |POLY 3 | P=0.264N P=0.765N P=0.627N P=0.551N |P=0.291N P=0.528 P=0.784 P=0.580N | |POLY 1.5 | P=0.255N P=0.763N P=0.586N P=0.534N |P=0.279N P=0.521 P=0.776 P=0.556N | |POLY 6 | P=0.276N P=0.768N P=0.672N P=0.572N |P=0.305N P=0.539 P=0.795 P=0.611N | |LOGISTIC REGRESSION| P=0.256N P=0.740N (e) (e) |P=0.263N P=0.501 P=0.736N (e) | |COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.247N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 2.7% 2.3% |2.3% 4.5% 2.3% 4.8% | |TERMINAL (d) | 0/40 (0%) 1/44 (2%) 1/29 (3%) 1/39 (3%) |1/32 (3%) 0/32 (0%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |735 (T) 691 735 (T) 664 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.363 P=0.519 P=0.436 P=0.495 |P=0.425 P=0.503 P=0.736N P=0.487 | |POLY 3 | P=0.395 P=0.548 P=0.560 P=0.549 |P=0.445 P=0.536 P=0.789 P=0.522 | |POLY 1.5 | P=0.391 P=0.531 P=0.537 P=0.532 |P=0.444 P=0.529 P=0.780 P=0.515 | |POLY 6 | P=0.398 P=0.564 P=0.586 P=0.566 |P=0.449 P=0.547 P=0.799 P=0.533 | |LOGISTIC REGRESSION| (e) P=0.519 P=0.436 P=0.495 |P=0.428 P=0.509 P=0.736N P=0.487 | |COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.450 P=0.508 P=0.747N P=0.508 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.3% 0.0% | | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 2/29 (7%) 0/39 (0%) | | |FIRST INCIDENCE | --- --- 729 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.574 (e) P=0.171 (e) | | |POLY 3 | P=0.616 (e) P=0.251 (e) | | |POLY 1.5 | P=0.609 (e) P=0.244 (e) | | |POLY 6 | P=0.623 (e) P=0.261 (e) | | |LOGISTIC REGRESSION| (e) (e) P=0.171 (e) | | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) | | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 2.7% 2.3% |2.2% 4.5% 2.3% 0.0% | |TERMINAL (d) | 1/40 (3%) 1/44 (2%) 1/29 (3%) 1/39 (3%) |1/32 (3%) 2/32 (6%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |735 (T) 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.604 P=0.740N P=0.688 P=0.756 |P=0.240N P=0.500 P=0.736N P=0.500N | |POLY 3 | P=0.634 P=0.765N P=0.774 P=0.786 |P=0.291N P=0.527 P=0.784 P=0.580N | |POLY 1.5 | P=0.633 P=0.763N P=0.767 P=0.777 |P=0.279N P=0.521 P=0.776 P=0.556N | |POLY 6 | P=0.635 P=0.768N P=0.782 P=0.794 |P=0.305N P=0.536 P=0.795 P=0.611N | |LOGISTIC REGRESSION| P=0.604 P=0.740N P=0.688 P=0.756 |P=0.240N P=0.500 P=0.736N (e) | |COCH-ARM / FISHERS | P=0.634 P=0.753N P=0.753N P=0.753N |P=0.247N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |2.2% 4.5% 2.3% 0.0% | |TERMINAL (d) | |1/32 (3%) 1/32 (3%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | |735 (T) 695 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.250N P=0.500 P=0.736N P=0.500N | |POLY 3 | |P=0.291N P=0.528 P=0.784 P=0.580N | |POLY 1.5 | |P=0.279N P=0.521 P=0.776 P=0.556N | |POLY 6 | |P=0.305N P=0.537 P=0.795 P=0.611N | |LOGISTIC REGRESSION| |P=0.267N P=0.494 P=0.736N (e) | |COCH-ARM / FISHERS | |P=0.247N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |2/50 (4%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| |4.5% 6.7% 2.3% 2.4% | |TERMINAL (d) | |2/32 (6%) 2/32 (6%) 1/36 (3%) 1/32 (3%) | |FIRST INCIDENCE | |735 (T) 695 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.278N P=0.500 P=0.459N P=0.500N | |POLY 3 | |P=0.322N P=0.521 P=0.542N P=0.564N | |POLY 1.5 | |P=0.310N P=0.518 P=0.529N P=0.545N | |POLY 6 | |P=0.334N P=0.526 P=0.560N P=0.586N | |LOGISTIC REGRESSION| |P=0.308N P=0.484 P=0.459N P=0.500N | |COCH-ARM / FISHERS | |P=0.279N P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.5% 0.0% 0.0% 0.0% |2.2% 4.5% 2.3% 2.4% | |TERMINAL (d) | 2/40 (5%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 1/32 (3%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |677 703 735 (T) 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.130N P=0.218N P=0.312N P=0.244N |P=0.549N P=0.494 P=0.759N P=0.739 | |POLY 3 | P=0.136N P=0.242N P=0.338N P=0.267N |P=0.576N P=0.525 P=0.782 P=0.779 | |POLY 1.5 | P=0.128N P=0.240N P=0.304N P=0.257N |P=0.564N P=0.520 P=0.775 P=0.772 | |POLY 6 | P=0.145N P=0.245N P=0.378N P=0.280N |P=0.588N P=0.533 P=0.792 P=0.789 | |LOGISTIC REGRESSION| P=0.130N (e) (e) (e) |P=0.538N P=0.502 P=0.759 P=0.754N | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.531N P=0.500 P=0.753N P=0.753N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |4/50 (8%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 11.0% 6.3% 10.6% 9.0% |8.9% 4.5% 6.9% 4.8% | |TERMINAL (d) | 3/40 (8%) 3/44 (7%) 3/29 (10%) 4/39 (10%) |3/32 (9%) 0/32 (0%) 2/36 (6%) 0/32 (0%) | |FIRST INCIDENCE | 501 729 (T) 602 729 (T) |673 691 655 664 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.554N P=0.315N P=0.602 P=0.517N |P=0.345N P=0.344N P=0.475N P=0.360N | |POLY 3 | P=0.548N P=0.340N P=0.641N P=0.531N |P=0.365N P=0.357N P=0.536N P=0.397N | |POLY 1.5 | P=0.532N P=0.345N P=0.600N P=0.520N |P=0.355N P=0.344N P=0.525N P=0.380N | |POLY 6 | P=0.567N P=0.337N P=0.668 P=0.547N |P=0.374N P=0.375N P=0.549N P=0.415N | |LOGISTIC REGRESSION| P=0.522N P=0.359N P=0.562N P=0.502N |P=0.343N P=0.336N P=0.513N P=0.365N | |COCH-ARM / FISHERS | P=0.500N P=0.357N P=0.500N P=0.500N |P=0.319N P=0.339N P=0.500N P=0.339N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |5/50 (10%) 3/50 (6%) 4/50 (8%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 15.4% 6.3% 10.6% 9.0% |11.1% 6.7% 9.2% 7.1% | |TERMINAL (d) | 5/40 (13%) 3/44 (7%) 3/29 (10%) 4/39 (10%) |3/32 (9%) 1/32 (3%) 3/36 (8%) 0/32 (0%) | |FIRST INCIDENCE | 501 729 (T) 602 729 (T) |673 691 655 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.336N P=0.131N P=0.446N P=0.280N |P=0.371N P=0.367N P=0.477N P=0.392N | |POLY 3 | P=0.324N P=0.144N P=0.400N P=0.287N |P=0.390N P=0.377N P=0.538N P=0.416N | |POLY 1.5 | P=0.309N P=0.148N P=0.357N P=0.278N |P=0.381N P=0.363N P=0.527N P=0.400N | |POLY 6 | P=0.341N P=0.141N P=0.449N P=0.301N |P=0.397N P=0.397N P=0.554N P=0.431N | |LOGISTIC REGRESSION| P=0.303N P=0.152N P=0.333N P=0.264N |P=0.365N P=0.354N P=0.514N P=0.373N | |COCH-ARM / FISHERS | P=0.279N P=0.159N P=0.262N P=0.262N |P=0.341N P=0.357N P=0.500N P=0.357N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 2.1% 0.0% 0.0% |4.5% 2.2% 4.6% 0.0% | |TERMINAL (d) | 2/40 (5%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 665 --- --- |726 662 697 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.118N P=0.465N P=0.312N P=0.244N |P=0.218N P=0.519N P=0.683N P=0.256N | |POLY 3 | P=0.118N P=0.495N P=0.338N P=0.267N |P=0.239N P=0.528N P=0.708 P=0.294N | |POLY 1.5 | P=0.112N P=0.496N P=0.304N P=0.257N |P=0.229N P=0.514N P=0.703 P=0.276N | |POLY 6 | P=0.125N P=0.494N P=0.378N P=0.280N |P=0.250N P=0.548N P=0.716 P=0.315N | |LOGISTIC REGRESSION| P=0.107N P=0.492N (e) (e) |P=0.212N P=0.498N P=0.683 P=0.259N | |COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.200N P=0.500N P=0.691N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 4/50 (8%) |12/50 (24%) 15/50 (30%) 12/50 (24%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 6.7% 4.2% 0.0% 9.0% |26.7% 31.8% 27.4% 25.5% | |TERMINAL (d) | 3/40 (8%) 1/44 (2%) 0/29 (0%) 3/39 (8%) |8/32 (25%) 9/32 (28%) 10/36 (28%) 8/32 (25%) | |FIRST INCIDENCE | 729 (T) 665 --- 617 |683 449 645 238 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.351 P=0.455N P=0.183N P=0.490 |P=0.371N P=0.328 P=0.497N P=0.522N | |POLY 3 | P=0.368 P=0.483N P=0.189N P=0.520 |P=0.421N P=0.388 P=0.579 P=0.556N | |POLY 1.5 | P=0.373 P=0.489N P=0.164N P=0.512 |P=0.405N P=0.378 P=0.581 P=0.542N | |POLY 6 | P=0.362 P=0.478N P=0.219N P=0.526 |P=0.434N P=0.395 P=0.578 P=0.570N | |LOGISTIC REGRESSION| P=0.369 P=0.476N (e) P=0.496 |P=0.385N P=0.328 P=0.548 P=0.542N | |COCH-ARM / FISHERS | P=0.387 P=0.500N P=0.121N P=0.500 |P=0.350N P=0.326 P=0.592N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |10/50 (20%) 14/50 (28%) 10/50 (20%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 0.0% 9.0% |22.3% 29.9% 22.9% 25.5% | |TERMINAL (d) | 1/40 (3%) 1/44 (2%) 0/29 (0%) 3/39 (8%) |8/32 (25%) 9/32 (28%) 9/36 (25%) 8/32 (25%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 617 |683 449 645 238 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.057 P=0.740N P=0.564N P=0.177 |P=0.522N P=0.246 P=0.502N P=0.484 | |POLY 3 | P=0.057 P=0.765N P=0.627N P=0.194 |P=0.525 P=0.287 P=0.587 P=0.474 | |POLY 1.5 | P=0.058 P=0.763N P=0.586N P=0.188 |P=0.536 P=0.280 P=0.588 P=0.479 | |POLY 6 | P=0.056 P=0.768N P=0.672N P=0.199 |P=0.520 P=0.289 P=0.585 P=0.474 | |LOGISTIC REGRESSION| P=0.058 P=0.740N (e) P=0.178 |P=0.544N P=0.241 P=0.559 P=0.465 | |COCH-ARM / FISHERS | P=0.062 P=0.753N P=0.500N P=0.181 |P=0.511N P=0.241 P=0.598N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 41/50 (82%) 39/50 (78%) 36/50 (72%) 34/50 (68%) |42/50 (84%) 43/50 (86%) 43/50 (86%) 41/50 (82%) | |POLY-3 ADJUSTED (b)| 87.1% 81.2% 84.3% 72.3% |89.0% 89.5% 93.9% 90.5% | |TERMINAL (d) | 36/40 (90%) 37/44 (84%) 25/29 (86%) 27/39 (69%) |30/32 (94%) 29/32 (91%) 36/36 (100%) 29/32 (91%) | |FIRST INCIDENCE | 220 645 377 543 |587 449 543 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.243N P=0.126N P=0.140 P=0.150N |P=0.489N P=0.465 P=0.384N P=0.564 | |POLY 3 | P=0.044N* P=0.307N P=0.485N P=0.058N |P=0.428 P=0.612 P=0.314 P=0.553 | |POLY 1.5 | P=0.055N P=0.350N P=0.425N P=0.074N |P=0.468 P=0.629 P=0.376 P=0.583 | |POLY 6 | P=0.031N* P=0.258N P=0.527N P=0.041N* |P=0.402 P=0.559 P=0.221 P=0.529 | |LOGISTIC REGRESSION| P=0.075N P=0.230N P=0.508N P=0.079N |P=0.351 P=0.560 P=0.353 P=0.464 | |COCH-ARM / FISHERS | P=0.055N P=0.402N P=0.171N P=0.083N |P=0.409N P=0.500 P=0.500 P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 32/50 (64%) 17/50 (34%) 15/50 (30%) 24/50 (48%) |28/50 (56%) 30/50 (60%) 26/50 (52%) 22/50 (44%) | |POLY-3 ADJUSTED (b)| 66.9% 34.3% 36.2% 51.7% |59.2% 60.4% 56.8% 49.2% | |TERMINAL (d) | 26/40 (65%) 13/44 (30%) 6/29 (21%) 18/39 (46%) |17/32 (53%) 16/32 (50%) 18/36 (50%) 14/32 (44%) | |FIRST INCIDENCE | 220 335 458 543 |465 449 540 238 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.307N P=0.002N** P=0.046N* P=0.127N |P=0.155N P=0.419 P=0.332N P=0.238N | |POLY 3 | P=0.237N P<0.001N** P=0.003N** P=0.098N |P=0.162N P=0.534 P=0.496N P=0.231N | |POLY 1.5 | P=0.219N P<0.001N** P=0.002N** P=0.095N |P=0.137N P=0.514 P=0.478N P=0.207N | |POLY 6 | P=0.249N P<0.001N** P=0.004N** P=0.099N |P=0.191N P=0.552 P=0.509N P=0.258N | |LOGISTIC REGRESSION| P=0.178N P=0.004N** P<0.001N** P=0.080N |P=0.101N P=0.413 P=0.453N P=0.190N | |COCH-ARM / FISHERS | P=0.168N P=0.002N** P<0.001N** P=0.079N |P=0.082N P=0.420 P=0.421N P=0.159N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 44/50 (88%) 40/50 (80%) 42/50 (84%) |46/50 (92%) 49/50 (98%) 47/50 (94%) 44/50 (88%) | |POLY-3 ADJUSTED (b)| 98.7% 88.2% 89.9% 88.8% |95.9% 98.0% 99.7% 94.6% | |TERMINAL (d) | 40/40 (100%) 39/44 (89%) 25/29 (86%) 34/39 (87%) |31/32 (97%) 31/32 (97%) 36/36 (100%) 30/32 (94%) | |FIRST INCIDENCE | 220 335 377 543 |465 449 540 238 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.381N P=0.045N* P=0.248 P=0.188N |P=0.384N P=0.333 P=0.401N P=0.520N | |POLY 3 | P=0.106N P=0.039N* P=0.068N P=0.048N* |P=0.431N P=0.499 P=0.293 P=0.587N | |POLY 1.5 | P=0.094N P=0.061N P=0.060N P=0.051N |P=0.346N P=0.443 P=0.321 P=0.533N | |POLY 6 | P=0.101N P=0.026N* P=0.065N P=0.039N* |P=0.492N P=0.529 P=0.282 P=0.627N | |LOGISTIC REGRESSION| P=0.067N P=0.097N P=0.093N P=0.037N* |P=0.448N P=0.299 P=0.355 P=0.625N | |COCH-ARM / FISHERS | P=0.051N P=0.134N P=0.014N* P=0.046N* |P=0.151N P=0.181 P=0.500 P=0.370N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (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. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers 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).