TDMS Study 05160-05 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: 05 TIME: 09:05:53 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-05300 ROUTE: DOSED WATER NTP C#: 61983C PATHOLOGIST: STEDHAM, M. CAS: 127-00-4 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 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: 05 TIME: 09:05:53 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-05300 ROUTE: DOSED WATER NTP C#: 61983C PATHOLOGIST: STEDHAM, M. CAS: 127-00-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF 1-CHLORO-2-PROPANOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or UnspeAdenomaSite Carcinoma or Adenoma Testes Adenoma =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Clitoral/Preputial Gland Adenoma Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma =============================================================== Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 14/49 (29%) 17/49 (35%) 12/50 (24%) |2/49 (4%) 5/50 (10%) 1/50 (2%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 32.7% 33.5% 41.4% 28.1% |4.6% 10.8% 2.3% 8.9% | |TERMINAL (d) | 8/20 (40%) 8/23 (35%) 11/24 (46%) 8/23 (35%) |0/25 (0%) 3/33 (9%) 1/30 (3%) 3/31 (10%) | |FIRST INCIDENCE | 580 609 627 585 |659 627 734 (T) 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.341N P=0.494N P=0.447 P=0.353N |P=0.477 P=0.308 P=0.463N P=0.407 | |POLY 3 | P=0.375N P=0.585 P=0.295 P=0.433N |P=0.451 P=0.256 P=0.524N P=0.370 | |POLY 1.5 | P=0.403N P=0.537 P=0.268 P=0.458N |P=0.446 P=0.240 P=0.510N P=0.358 | |POLY 6 | P=0.351N P=0.611N P=0.339 P=0.409N |P=0.462 P=0.284 P=0.544N P=0.391 | |LOGISTIC REGRESSION| P=0.348N P=0.546N P=0.330 P=0.375N |P=0.441 P=0.223 P=0.493N P=0.352 | |COCH-ARM / FISHERS | P=0.452N P=0.475 P=0.235 P=0.500N |P=0.441 P=0.226 P=0.492N P=0.349 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/49 (2%) 2/50 (4%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 0.0% 2.5% 4.8% |2.3% 2.2% 0.0% 2.2% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 2/23 (9%) |0/25 (0%) 1/33 (3%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE | 693 --- 729 (T) 729 (T) |701 734 (T) --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.257 P=0.467N P=0.736N P=0.536 |P=0.590N P=0.714N P=0.489N P=0.730N | |POLY 3 | P=0.271 P=0.585N P=0.807N P=0.580 |P=0.627N P=0.773N P=0.548N P=0.782N | |POLY 1.5 | P=0.259 P=0.548N P=0.788N P=0.545 |P=0.618N P=0.767N P=0.525N P=0.771N | |POLY 6 | P=0.289 P=0.643N P=0.836N P=0.629 |P=0.639N P=0.782N P=0.584N P=0.797N | |LOGISTIC REGRESSION| P=0.258 P=0.489N P=0.746N P=0.543 |P=0.605N P=0.747N P=0.496N P=0.752N | |COCH-ARM / FISHERS | P=0.243 P=0.505N P=0.747 P=0.500 |P=0.609N P=0.747N P=0.495N P=0.747N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 14/49 (29%) 18/49 (37%) 13/50 (26%) |4/49 (8%) 5/50 (10%) 1/50 (2%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 35.1% 33.5% 43.8% 30.4% |9.1% 10.8% 2.3% 11.2% | |TERMINAL (d) | 8/20 (40%) 8/23 (35%) 12/24 (50%) 9/23 (39%) |0/25 (0%) 3/33 (9%) 1/30 (3%) 4/31 (13%) | |FIRST INCIDENCE | 580 609 627 585 |629 627 734 (T) 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.370N P=0.403N P=0.457 P=0.350N |P=0.568 P=0.603 P=0.166N P=0.576 | |POLY 3 | P=0.413N P=0.552N P=0.295 P=0.432N |P=0.535 P=0.547 P=0.191N P=0.528 | |POLY 1.5 | P=0.439N P=0.578N P=0.269 P=0.457N |P=0.534 P=0.528 P=0.183N P=0.519 | |POLY 6 | P=0.393N P=0.519N P=0.334 P=0.410N |P=0.538 P=0.576 P=0.203N P=0.543 | |LOGISTIC REGRESSION| P=0.376N P=0.449N P=0.337 P=0.367N |P=0.534 P=0.510 P=0.172N P=0.514 | |COCH-ARM / FISHERS | P=0.485N P=0.563 P=0.238 P=0.500N |P=0.534 P=0.513 P=0.175N P=0.513 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/49 (4%) |1/49 (2%) 0/49 (0%) 2/49 (4%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 2.6% 2.4% 4.9% 4.9% |2.3% 0.0% 4.6% 9.1% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 2/24 (8%) 2/23 (9%) |1/25 (4%) 0/32 (0%) 1/29 (3%) 3/31 (10%) | |FIRST INCIDENCE | 709 729 (T) 729 (T) 729 (T) |734 (T) --- 608 649 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.367 P=0.723N P=0.560 P=0.546 |P=0.046 * P=0.451N P=0.532 P=0.239 | |POLY 3 | P=0.369 P=0.798N P=0.575 P=0.574 |P=0.039 * P=0.539N P=0.537 P=0.202 | |POLY 1.5 | P=0.352 P=0.781N P=0.542 P=0.538 |P=0.038 * P=0.523N P=0.519 P=0.190 | |POLY 6 | P=0.393 P=0.825N P=0.624 P=0.625 |P=0.041 * P=0.565N P=0.567 P=0.223 | |LOGISTIC REGRESSION| P=0.357 P=0.731N P=0.539 P=0.543 |P=0.038 * (e) P=0.500 P=0.189 | |COCH-ARM / FISHERS | P=0.327 P=0.753N P=0.500 P=0.492 |P=0.038 * P=0.500N P=0.500 P=0.181 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 5/50 (10%) 3/49 (6%) |4/49 (8%) 4/49 (8%) 2/49 (4%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 2.6% 9.6% 12.0% 7.2% |9.3% 8.9% 4.6% 6.9% | |TERMINAL (d) | 1/20 (5%) 4/23 (17%) 2/24 (8%) 2/23 (9%) |4/25 (16%) 2/32 (6%) 2/29 (7%) 2/31 (7%) | |FIRST INCIDENCE | 729 (T) 729 (T) 592 585 |734 (T) 708 734 (T) 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.384 P=0.218 P=0.140 P=0.353 |P=0.303N P=0.516N P=0.267N P=0.391N | |POLY 3 | P=0.394 P=0.232 P=0.138 P=0.373 |P=0.371N P=0.634N P=0.354N P=0.510N | |POLY 1.5 | P=0.365 P=0.208 P=0.121 P=0.340 |P=0.369N P=0.642N P=0.347N P=0.507N | |POLY 6 | P=0.432 P=0.271 P=0.168 P=0.424 |P=0.372N P=0.620N P=0.363N P=0.510N | |LOGISTIC REGRESSION| P=0.355 P=0.218 P=0.110 P=0.323 |P=0.341N P=0.562N P=0.267N P=0.447N | |COCH-ARM / FISHERS | P=0.325 P=0.181 P=0.102 P=0.301 |P=0.364N P=0.643N P=0.339N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 7/50 (14%) 5/49 (10%) |5/49 (10%) 4/49 (8%) 4/49 (8%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 5.1% 12.0% 16.8% 12.0% |11.7% 8.9% 9.2% 15.9% | |TERMINAL (d) | 1/20 (5%) 5/23 (22%) 4/24 (17%) 4/23 (17%) |5/25 (20%) 2/32 (6%) 3/29 (10%) 5/31 (16%) | |FIRST INCIDENCE | 709 729 (T) 592 585 |734 (T) 708 608 649 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.270 P=0.276 P=0.125 P=0.272 |P=0.326 P=0.361N P=0.418N P=0.519 | |POLY 3 | P=0.267 P=0.273 P=0.109 P=0.271 |P=0.268 P=0.487N P=0.507N P=0.413 | |POLY 1.5 | P=0.243 P=0.248 P=0.095 P=0.243 |P=0.265 P=0.497N P=0.505N P=0.395 | |POLY 6 | P=0.298 P=0.313 P=0.132 P=0.312 |P=0.278 P=0.469N P=0.508N P=0.447 | |LOGISTIC REGRESSION| P=0.248 P=0.285 P=0.093 P=0.251 |P=0.263 P=0.405N P=0.481N P=0.423 | |COCH-ARM / FISHERS | P=0.211 P=0.218 P=0.080 P=0.210 |P=0.259 P=0.500N P=0.500N P=0.380 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 1/45 (2%) 2/46 (4%) 3/47 (6%) |1/46 (2%) 1/49 (2%) 1/48 (2%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 5.2% 2.6% 5.2% 7.7% |2.5% 2.2% 2.3% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 1/24 (4%) 3/23 (13%) |0/25 (0%) 1/33 (3%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE | 637 729 (T) 667 729 (T) |729 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.351 P=0.461N P=0.645N P=0.561 |P=0.279N P=0.706N P=0.724N P=0.460N | |POLY 3 | P=0.333 P=0.557N P=0.734N P=0.555 |P=0.314N P=0.764N P=0.777N P=0.531N | |POLY 1.5 | P=0.320 P=0.544N P=0.709 P=0.523 |P=0.310N P=0.758N P=0.765N P=0.513N | |POLY 6 | P=0.349 P=0.579N P=0.749N P=0.599 |P=0.321N P=0.774N P=0.792N P=0.559N | |LOGISTIC REGRESSION| P=0.329 P=0.495N P=0.696N P=0.538 |P=0.286N P=0.724N P=0.739N P=0.474N | |COCH-ARM / FISHERS | P=0.301 P=0.532N P=0.667 P=0.480 |P=0.304N P=0.737N P=0.742N P=0.489N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 1/45 (2%) 2/46 (4%) 4/47 (9%) |1/46 (2%) 2/49 (4%) 1/48 (2%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 5.2% 2.6% 5.2% 10.2% |2.5% 4.5% 2.3% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 1/24 (4%) 4/23 (17%) |0/25 (0%) 2/33 (6%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE | 637 729 (T) 667 729 (T) |729 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.192 P=0.461N P=0.645N P=0.402 |P=0.209N P=0.587 P=0.724N P=0.460N | |POLY 3 | P=0.176 P=0.557N P=0.734N P=0.386 |P=0.239N P=0.559 P=0.777N P=0.531N | |POLY 1.5 | P=0.168 P=0.544N P=0.709 P=0.356 |P=0.237N P=0.541 P=0.765N P=0.513N | |POLY 6 | P=0.186 P=0.579N P=0.749N P=0.428 |P=0.241N P=0.587 P=0.792N P=0.559N | |LOGISTIC REGRESSION| P=0.176 P=0.495N P=0.696N P=0.378 |P=0.214N P=0.564 P=0.739N P=0.474N | |COCH-ARM / FISHERS | P=0.156 P=0.532N P=0.667 P=0.319 |P=0.234N P=0.524 P=0.742N P=0.489N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/49 (4%) 1/50 (2%) |0/46 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.0% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 2/24 (8%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.259 (e) P=0.278 P=0.528 |(e) (e) (e) (e) | |POLY 3 | P=0.285 (e) P=0.305 P=0.611 |(e) (e) (e) (e) | |POLY 1.5 | P=0.266 (e) P=0.271 P=0.561 |(e) (e) (e) (e) | |POLY 6 | P=0.312 (e) P=0.360 P=0.684 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.278 P=0.528 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.242 (e) P=0.242 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 7.1% 2.5% 4.8% |0.0% 0.0% 2.3% 2.2% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 1/24 (4%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | 729 (T) 630 729 (T) 676 |--- --- 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.583 P=0.356 P=0.722N P=0.554 |P=0.250 (e) P=0.536 P=0.543 | |POLY 3 | P=0.588 P=0.379 P=0.805N P=0.583 |P=0.251 (e) P=0.556 P=0.556 | |POLY 1.5 | P=0.566 P=0.345 P=0.785N P=0.546 |P=0.242 (e) P=0.530 P=0.530 | |POLY 6 | P=0.617 P=0.431 P=0.836N P=0.635 |P=0.265 (e) P=0.598 P=0.598 | |LOGISTIC REGRESSION| P=0.565 P=0.341 P=0.722N P=0.540 |(e) (e) P=0.536 P=0.543 | |COCH-ARM / FISHERS | P=0.536 P=0.309 P=0.753N P=0.500 |P=0.231 (e) P=0.500 P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 7.1% 4.9% 7.1% |0.0% 0.0% 2.3% 2.2% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 2/24 (8%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | 729 (T) 630 729 (T) 569 |--- --- 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.354 P=0.356 P=0.564 P=0.356 |P=0.250 (e) P=0.536 P=0.543 | |POLY 3 | P=0.360 P=0.379 P=0.576 P=0.382 |P=0.251 (e) P=0.556 P=0.556 | |POLY 1.5 | P=0.338 P=0.345 P=0.542 P=0.348 |P=0.242 (e) P=0.530 P=0.530 | |POLY 6 | P=0.390 P=0.431 P=0.627 P=0.434 |P=0.265 (e) P=0.598 P=0.598 | |LOGISTIC REGRESSION| P=0.328 P=0.341 P=0.564 P=0.311 |(e) (e) P=0.536 P=0.543 | |COCH-ARM / FISHERS | P=0.308 P=0.309 P=0.500 P=0.309 |P=0.231 (e) P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 7.1% 4.9% 7.1% |0.0% 0.0% 2.3% 2.2% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 2/24 (8%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | 729 (T) 630 729 (T) 569 |--- --- 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.354 P=0.356 P=0.564 P=0.356 |P=0.250 (e) P=0.536 P=0.543 | |POLY 3 | P=0.360 P=0.379 P=0.576 P=0.382 |P=0.251 (e) P=0.556 P=0.556 | |POLY 1.5 | P=0.338 P=0.345 P=0.542 P=0.348 |P=0.242 (e) P=0.530 P=0.530 | |POLY 6 | P=0.390 P=0.431 P=0.627 P=0.434 |P=0.265 (e) P=0.598 P=0.598 | |LOGISTIC REGRESSION| P=0.328 P=0.341 P=0.564 P=0.311 |(e) (e) P=0.536 P=0.543 | |COCH-ARM / FISHERS | P=0.308 P=0.309 P=0.500 P=0.309 |P=0.231 (e) P=0.500 P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 2.5% 0.0% |0.0% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 1/24 (4%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE | --- 388 729 (T) --- |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426N P=0.257 P=0.536 (e) |P=0.208 (e) (e) P=0.543 | |POLY 3 | P=0.447N P=0.314 P=0.611 (e) |P=0.220 (e) (e) P=0.556 | |POLY 1.5 | P=0.444N P=0.279 P=0.561 (e) |P=0.210 (e) (e) P=0.530 | |POLY 6 | P=0.459N P=0.371 P=0.685 (e) |P=0.237 (e) (e) P=0.598 | |LOGISTIC REGRESSION| P=0.497N P=0.171 P=0.536 (e) |(e) (e) (e) P=0.543 | |COCH-ARM / FISHERS | P=0.446N P=0.247 P=0.500 (e) |P=0.196 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 686 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.255 (e) P=0.267 P=0.528 |(e) (e) (e) (e) | |POLY 3 | P=0.284 (e) P=0.310 P=0.611 |(e) (e) (e) (e) | |POLY 1.5 | P=0.265 (e) P=0.276 P=0.561 |(e) (e) (e) (e) | |POLY 6 | P=0.312 (e) P=0.365 P=0.684 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.255 (e) P=0.253 P=0.528 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.240 (e) P=0.247 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 7.3% 2.4% |0.0% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 2/24 (8%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE | --- 388 686 729 (T) |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.478 P=0.257 P=0.149 P=0.528 |P=0.208 (e) (e) P=0.543 | |POLY 3 | P=0.509 P=0.314 P=0.161 P=0.611 |P=0.220 (e) (e) P=0.556 | |POLY 1.5 | P=0.484 P=0.279 P=0.141 P=0.561 |P=0.210 (e) (e) P=0.530 | |POLY 6 | P=0.541 P=0.371 P=0.196 P=0.684 |P=0.237 (e) (e) P=0.598 | |LOGISTIC REGRESSION| P=0.441 P=0.171 P=0.135 P=0.528 |(e) (e) (e) P=0.543 | |COCH-ARM / FISHERS | P=0.449 P=0.247 P=0.121 P=0.500 |P=0.196 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 4.3% 2.2% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 1/33 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 627 608 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.230N P=0.562 P=0.748N P=0.460N | |POLY 3 | (e) (e) (e) (e) |P=0.251N P=0.544 P=0.785N P=0.549N | |POLY 1.5 | (e) (e) (e) (e) |P=0.247N P=0.522 P=0.774N P=0.527N | |POLY 6 | (e) (e) (e) (e) |P=0.254N P=0.579 P=0.800N P=0.582N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.241N P=0.498 P=0.759N P=0.478N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.241N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 0/50 (0%) 6/50 (12%) 6/50 (12%) |29/50 (58%) 28/50 (56%) 31/50 (62%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 17.7% 0.0% 14.6% 14.2% |62.1% 59.3% 67.6% 50.6% | |TERMINAL (d) | 5/20 (25%) 0/23 (0%) 5/24 (21%) 3/23 (13%) |16/25 (64%) 21/33 (64%) 22/30 (73%) 17/31 (55%) | |FIRST INCIDENCE | 585 --- 573 648 |541 627 608 561 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426 P=0.006N** P=0.386N P=0.405N |P=0.068N P=0.135N P=0.438N P=0.050N | |POLY 3 | P=0.394 P=0.007N** P=0.496N P=0.474N |P=0.175N P=0.479N P=0.371 P=0.182N | |POLY 1.5 | P=0.382 P=0.007N** P=0.496N P=0.483N |P=0.158N P=0.504N P=0.388 P=0.173N | |POLY 6 | P=0.410 P=0.008N** P=0.501N P=0.471N |P=0.200N P=0.435N P=0.362 P=0.192N | |LOGISTIC REGRESSION| P=0.409 P=0.006N** P=0.448N P=0.422N |P=0.131N P=0.438N P=0.433 P=0.132N | |COCH-ARM / FISHERS | P=0.366 P=0.006N** P=0.500N P=0.500N |P=0.141N P=0.500N P=0.419 P=0.158N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 0/50 (0%) 6/50 (12%) 6/50 (12%) |29/50 (58%) 28/50 (56%) 31/50 (62%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 17.7% 0.0% 14.6% 14.2% |62.1% 59.3% 67.6% 50.6% | |TERMINAL (d) | 5/20 (25%) 0/23 (0%) 5/24 (21%) 3/23 (13%) |16/25 (64%) 21/33 (64%) 22/30 (73%) 17/31 (55%) | |FIRST INCIDENCE | 585 --- 573 648 |541 627 608 561 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426 P=0.006N** P=0.386N P=0.405N |P=0.068N P=0.135N P=0.438N P=0.050N | |POLY 3 | P=0.394 P=0.007N** P=0.496N P=0.474N |P=0.175N P=0.479N P=0.371 P=0.182N | |POLY 1.5 | P=0.382 P=0.007N** P=0.496N P=0.483N |P=0.158N P=0.504N P=0.388 P=0.173N | |POLY 6 | P=0.410 P=0.008N** P=0.501N P=0.471N |P=0.200N P=0.435N P=0.362 P=0.192N | |LOGISTIC REGRESSION| P=0.409 P=0.006N** P=0.448N P=0.422N |P=0.131N P=0.438N P=0.433 P=0.132N | |COCH-ARM / FISHERS | P=0.366 P=0.006N** P=0.500N P=0.500N |P=0.141N P=0.500N P=0.419 P=0.158N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 7/50 (14%) 0/50 (0%) 6/50 (12%) 6/50 (12%) |30/50 (60%) 28/50 (56%) 31/50 (62%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 17.7% 0.0% 14.6% 14.2% |64.2% 59.3% 67.6% 50.6% | |TERMINAL (d) | 5/20 (25%) 0/23 (0%) 5/24 (21%) 3/23 (13%) |16/25 (64%) 21/33 (64%) 22/30 (73%) 17/31 (55%) | |FIRST INCIDENCE | 585 --- 573 648 |541 627 608 561 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426 P=0.006N** P=0.386N P=0.405N |P=0.051N P=0.101N P=0.369N P=0.035N* | |POLY 3 | P=0.394 P=0.007N** P=0.496N P=0.474N |P=0.133N P=0.395N P=0.456 P=0.130N | |POLY 1.5 | P=0.382 P=0.007N** P=0.496N P=0.483N |P=0.119N P=0.421N P=0.471 P=0.124N | |POLY 6 | P=0.410 P=0.008N** P=0.501N P=0.471N |P=0.153N P=0.349N P=0.449 P=0.136N | |LOGISTIC REGRESSION| P=0.409 P=0.006N** P=0.448N P=0.422N |P=0.097N P=0.353N P=0.518 P=0.091N | |COCH-ARM / FISHERS | P=0.366 P=0.006N** P=0.500N P=0.500N |P=0.107N P=0.420N P=0.500 P=0.115N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 0.0% |4.6% 2.2% 2.3% 2.2% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |2/25 (8%) 1/33 (3%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | 579 --- --- --- |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.308N P=0.491N P=0.500N P=0.491N |P=0.368N P=0.403N P=0.436N P=0.425N | |POLY 3 | P=0.371N P=0.583N P=0.593N P=0.582N |P=0.429N P=0.512N P=0.528N P=0.525N | |POLY 1.5 | P=0.343N P=0.545N P=0.550N P=0.543N |P=0.422N P=0.509N P=0.516N P=0.514N | |POLY 6 | P=0.417N P=0.642N P=0.658N P=0.644N |P=0.440N P=0.517N P=0.546N P=0.538N | |LOGISTIC REGRESSION| P=0.354N P=0.547N P=0.536N P=0.588N |P=0.368N P=0.403N P=0.436N P=0.425N | |COCH-ARM / FISHERS | P=0.311N P=0.500N P=0.500N P=0.500N |P=0.412N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 0.0% |4.6% 4.4% 2.3% 2.2% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |2/25 (8%) 1/33 (3%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | 579 --- --- --- |734 (T) 708 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.308N P=0.491N P=0.500N P=0.491N |P=0.295N P=0.601N P=0.436N P=0.425N | |POLY 3 | P=0.371N P=0.583N P=0.593N P=0.582N |P=0.347N P=0.698N P=0.528N P=0.525N | |POLY 1.5 | P=0.343N P=0.545N P=0.550N P=0.543N |P=0.342N P=0.699N P=0.516N P=0.514N | |POLY 6 | P=0.417N P=0.642N P=0.658N P=0.644N |P=0.353N P=0.698N P=0.546N P=0.538N | |LOGISTIC REGRESSION| P=0.354N P=0.547N P=0.536N P=0.588N |P=0.312N P=0.642N P=0.436N P=0.425N | |COCH-ARM / FISHERS | P=0.311N P=0.500N P=0.500N P=0.500N |P=0.334N P=0.691N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/48 (31%) 20/49 (41%) 25/49 (51%) 24/50 (48%) |29/49 (59%) 30/50 (60%) 32/50 (64%) 35/50 (70%) | |POLY-3 ADJUSTED (b)| 37.4% 46.9% 57.2% 53.2% |62.9% 63.6% 66.5% 73.5% | |TERMINAL (d) | 7/20 (35%) 12/23 (52%) 13/24 (54%) 15/23 (65%) |17/25 (68%) 21/33 (64%) 19/30 (63%) 23/31 (74%) | |FIRST INCIDENCE | 502 502 559 502 |541 676 506 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.116 P=0.378 P=0.127 P=0.144 |P=0.315 P=0.210N P=0.514N P=0.507 | |POLY 3 | P=0.090 P=0.264 P=0.052 P=0.106 |P=0.132 P=0.565 P=0.444 P=0.185 | |POLY 1.5 | P=0.075 P=0.246 P=0.044 * P=0.089 |P=0.130 P=0.541 P=0.417 P=0.178 | |POLY 6 | P=0.110 P=0.292 P=0.070 P=0.128 |P=0.143 P=0.580N P=0.487 P=0.210 | |LOGISTIC REGRESSION| P=0.070 P=0.285 P=0.045 * P=0.087 |P=0.122 P=0.559N P=0.387 P=0.180 | |COCH-ARM / FISHERS | P=0.057 P=0.221 P=0.038 * P=0.068 |P=0.127 P=0.548 P=0.387 P=0.180 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/48 (31%) 20/49 (41%) 25/49 (51%) 24/50 (48%) |30/49 (61%) 30/50 (60%) 32/50 (64%) 35/50 (70%) | |POLY-3 ADJUSTED (b)| 37.4% 46.9% 57.2% 53.2% |65.0% 63.6% 66.5% 73.5% | |TERMINAL (d) | 7/20 (35%) 12/23 (52%) 13/24 (54%) 15/23 (65%) |17/25 (68%) 21/33 (64%) 19/30 (63%) 23/31 (74%) | |FIRST INCIDENCE | 502 502 559 502 |541 676 506 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.116 P=0.378 P=0.127 P=0.144 |P=0.368 P=0.164N P=0.447N P=0.556N | |POLY 3 | P=0.090 P=0.264 P=0.052 P=0.106 |P=0.173 P=0.537N P=0.528 P=0.247 | |POLY 1.5 | P=0.075 P=0.246 P=0.044 * P=0.089 |P=0.170 P=0.552N P=0.501 P=0.239 | |POLY 6 | P=0.110 P=0.292 P=0.070 P=0.128 |P=0.184 P=0.498N P=0.571 P=0.275 | |LOGISTIC REGRESSION| P=0.070 P=0.285 P=0.045 * P=0.087 |P=0.160 P=0.474N P=0.469 P=0.240 | |COCH-ARM / FISHERS | P=0.057 P=0.221 P=0.038 * P=0.068 |P=0.166 P=0.532N P=0.469 P=0.240 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 3/50 (6%) 7/50 (14%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.7% 14.1% 7.4% 16.5% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 3/23 (13%) 2/24 (8%) 3/23 (13%) |1/25 (4%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 697 544 720 582 |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.226 P=0.326 P=0.586N P=0.222 |P=0.293N P=0.445N P=0.464N P=0.457N | |POLY 3 | P=0.216 P=0.314 P=0.683N P=0.214 |P=0.347N P=0.538N P=0.552N P=0.549N | |POLY 1.5 | P=0.201 P=0.282 P=0.672N P=0.189 |P=0.330N P=0.523N P=0.529N P=0.527N | |POLY 6 | P=0.236 P=0.363 P=0.701N P=0.250 |P=0.374N P=0.563N P=0.589N P=0.582N | |LOGISTIC REGRESSION| P=0.208 P=0.276 P=0.614N P=0.200 |P=0.293N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.180 P=0.243 P=0.661N P=0.159 |P=0.311N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 8/50 (16%) 7/50 (14%) 6/50 (12%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 7.6% 18.7% 16.7% 14.1% |2.3% 0.0% 2.2% 4.5% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 4/24 (17%) 3/23 (13%) |1/25 (4%) 0/33 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE | 635 555 592 520 |734 (T) --- 659 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.403 P=0.165 P=0.220 P=0.306 |P=0.256 P=0.445N P=0.735N P=0.560 | |POLY 3 | P=0.406 P=0.140 P=0.202 P=0.308 |P=0.252 P=0.538N P=0.786N P=0.537 | |POLY 1.5 | P=0.380 P=0.121 P=0.182 P=0.280 |P=0.248 P=0.523N P=0.775N P=0.519 | |POLY 6 | P=0.435 P=0.170 P=0.232 P=0.345 |P=0.260 P=0.563N P=0.801N P=0.568 | |LOGISTIC REGRESSION| P=0.359 P=0.113 P=0.171 P=0.265 |P=0.241 (e) P=0.762 P=0.528 | |COCH-ARM / FISHERS | P=0.339 P=0.100 P=0.159 P=0.243 |P=0.241 P=0.500N P=0.753N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 9/50 (18%) 7/50 (14%) 7/50 (14%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 10.1% 21.0% 16.7% 16.3% |4.6% 0.0% 4.5% 6.7% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 4/24 (17%) 3/23 (13%) |2/25 (8%) 0/33 (0%) 0/30 (0%) 2/31 (7%) | |FIRST INCIDENCE | 635 555 592 520 |734 (T) --- 659 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426 P=0.198 P=0.337 P=0.331 |P=0.253 P=0.179N P=0.648N P=0.586 | |POLY 3 | P=0.436 P=0.161 P=0.318 P=0.336 |P=0.235 P=0.254N P=0.710N P=0.533 | |POLY 1.5 | P=0.406 P=0.141 P=0.293 P=0.305 |P=0.232 P=0.248N P=0.703N P=0.516 | |POLY 6 | P=0.468 P=0.193 P=0.354 P=0.376 |P=0.240 P=0.263N P=0.719N P=0.562 | |LOGISTIC REGRESSION| P=0.379 P=0.136 P=0.280 P=0.273 |P=0.229 (e) P=0.694N P=0.549 | |COCH-ARM / FISHERS | P=0.360 P=0.117 P=0.262 P=0.262 |P=0.228 P=0.247N P=0.691N P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 9.5% 7.4% 14.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 2/24 (8%) 3/23 (13%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 697 636 720 582 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.143 P=0.418 P=0.571 P=0.184 |(e) (e) (e) (e) | |POLY 3 | P=0.138 P=0.410 P=0.567 P=0.182 |(e) (e) (e) (e) | |POLY 1.5 | P=0.128 P=0.377 P=0.537 P=0.160 |(e) (e) (e) (e) | |POLY 6 | P=0.152 P=0.459 P=0.610 P=0.214 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.132 P=0.386 P=0.548 P=0.164 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.112 P=0.339 P=0.500 P=0.134 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 7/50 (14%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 11.7% 7.4% 16.5% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 2/24 (8%) 3/23 (13%) |1/25 (4%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 697 544 720 582 |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.108 P=0.289 P=0.571 P=0.122 |P=0.293N P=0.445N P=0.464N P=0.457N | |POLY 3 | P=0.101 P=0.282 P=0.567 P=0.114 |P=0.347N P=0.538N P=0.552N P=0.549N | |POLY 1.5 | P=0.093 P=0.252 P=0.537 P=0.098 |P=0.330N P=0.523N P=0.529N P=0.527N | |POLY 6 | P=0.113 P=0.328 P=0.610 P=0.138 |P=0.374N P=0.563N P=0.589N P=0.582N | |LOGISTIC REGRESSION| P=0.095 P=0.231 P=0.548 P=0.104 |P=0.293N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.082 P=0.218 P=0.500 P=0.080 |P=0.311N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 7/50 (14%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 9.5% 7.4% 16.5% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 2/24 (8%) 3/23 (13%) |1/25 (4%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 697 636 720 582 |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.078 P=0.418 P=0.571 P=0.122 |P=0.293N P=0.445N P=0.464N P=0.457N | |POLY 3 | P=0.072 P=0.410 P=0.567 P=0.114 |P=0.347N P=0.538N P=0.552N P=0.549N | |POLY 1.5 | P=0.066 P=0.377 P=0.537 P=0.098 |P=0.330N P=0.523N P=0.529N P=0.527N | |POLY 6 | P=0.080 P=0.459 P=0.610 P=0.138 |P=0.374N P=0.563N P=0.589N P=0.582N | |LOGISTIC REGRESSION| P=0.070 P=0.386 P=0.548 P=0.104 |P=0.293N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.058 P=0.339 P=0.500 P=0.080 |P=0.311N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 46/50 (92%) 43/49 (88%) 40/50 (80%) 46/50 (92%) | | |POLY-3 ADJUSTED (b)| 97.2% 91.8% 87.1% 94.2% | | |TERMINAL (d) | 20/20 (100%) 21/23 (91%) 23/24 (96%) 22/23 (96%) | | |FIRST INCIDENCE | 445 548 457 502 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.305N P=0.132N P=0.055N P=0.260N | | |POLY 3 | P=0.400N P=0.221N P=0.041N* P=0.411N | | |POLY 1.5 | P=0.455N P=0.273N P=0.046N* P=0.502N | | |POLY 6 | P=0.388N P=0.176N P=0.058N P=0.351N | | |LOGISTIC REGRESSION| P=0.355N P=0.154N P=0.019N* P=0.387N | | |COCH-ARM / FISHERS | P=0.552 P=0.357N P=0.074N P=0.643N | | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/50 (2%) 6/50 (12%) 3/50 (6%) |2/50 (4%) 8/50 (16%) 5/50 (10%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 12.7% 2.4% 14.5% 7.1% |4.6% 17.3% 11.3% 6.7% | |TERMINAL (d) | 4/20 (20%) 1/23 (4%) 2/24 (8%) 1/23 (4%) |2/25 (8%) 5/33 (15%) 5/30 (17%) 3/31 (10%) | |FIRST INCIDENCE | 532 729 (T) 592 676 |734 (T) 678 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.447N P=0.075N P=0.599 P=0.292N |P=0.374N P=0.105 P=0.292 P=0.599 | |POLY 3 | P=0.488N P=0.105N P=0.567 P=0.351N |P=0.446N P=0.058 P=0.235 P=0.532 | |POLY 1.5 | P=0.490N P=0.103N P=0.537 P=0.351N |P=0.449N P=0.051 P=0.226 P=0.516 | |POLY 6 | P=0.489N P=0.110N P=0.611 P=0.356N |P=0.435N P=0.071 P=0.253 P=0.560 | |LOGISTIC REGRESSION| P=0.467N P=0.085N P=0.531 P=0.317N |P=0.414N P=0.068 P=0.292 P=0.599 | |COCH-ARM / FISHERS | P=0.497N P=0.102N P=0.500 P=0.357N |P=0.449N P=0.046 * P=0.218 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% 0.0% 2.4% |0.0% 0.0% 2.3% 4.5% | |TERMINAL (d) | 0/20 (0%) 2/23 (9%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | --- 729 (T) --- 648 |--- --- 734 (T) 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.587 P=0.269 (e) P=0.539 |P=0.075 (e) P=0.536 P=0.269 | |POLY 3 | P=0.614 P=0.312 (e) P=0.610 |P=0.075 (e) P=0.556 P=0.272 | |POLY 1.5 | P=0.588 P=0.277 (e) P=0.561 |P=0.072 (e) P=0.530 P=0.255 | |POLY 6 | P=0.650 P=0.368 (e) P=0.683 |P=0.080 (e) P=0.598 P=0.301 | |LOGISTIC REGRESSION| P=0.570 P=0.269 (e) P=0.484 |P=0.068 (e) P=0.536 P=0.238 | |COCH-ARM / FISHERS | P=0.554 P=0.247 (e) P=0.500 |P=0.068 (e) P=0.500 P=0.247 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 6/50 (12%) 4/50 (8%) |2/50 (4%) 8/50 (16%) 6/50 (12%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 12.7% 7.2% 14.5% 9.4% |4.6% 17.3% 13.6% 11.2% | |TERMINAL (d) | 4/20 (20%) 3/23 (13%) 2/24 (8%) 1/23 (4%) |2/25 (8%) 5/33 (15%) 6/30 (20%) 4/31 (13%) | |FIRST INCIDENCE | 532 729 (T) 592 648 |734 (T) 678 734 (T) 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.480N P=0.282N P=0.599 P=0.419N |P=0.453 P=0.105 P=0.194 P=0.299 | |POLY 3 | P=0.517N P=0.358N P=0.567 P=0.486N |P=0.396 P=0.058 P=0.146 P=0.240 | |POLY 1.5 | P=0.526N P=0.356N P=0.537 P=0.490N |P=0.385 P=0.051 P=0.140 P=0.228 | |POLY 6 | P=0.509N P=0.364N P=0.611 P=0.486N |P=0.419 P=0.071 P=0.159 P=0.264 | |LOGISTIC REGRESSION| P=0.506N P=0.300N P=0.531 P=0.465N |P=0.399 P=0.068 P=0.194 P=0.244 | |COCH-ARM / FISHERS | P=0.541N P=0.357N P=0.500 P=0.500N |P=0.376 P=0.046 * P=0.134 P=0.218 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Tongue | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.6% 2.2% 0.0% 2.2% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |2/25 (8%) 1/33 (3%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE | --- --- --- --- |734 (T) 734 (T) --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.329N P=0.403N P=0.198N P=0.425N | |POLY 3 | (e) (e) (e) (e) |P=0.386N P=0.512N P=0.266N P=0.525N | |POLY 1.5 | (e) (e) (e) (e) |P=0.378N P=0.509N P=0.253N P=0.514N | |POLY 6 | (e) (e) (e) (e) |P=0.399N P=0.517N P=0.286N P=0.538N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.329N P=0.403N (e) P=0.425N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.367N P=0.500N P=0.247N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |7/50 (14%) 6/50 (12%) 6/50 (12%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| |15.7% 13.0% 13.3% 9.0% | |TERMINAL (d) | |2/25 (8%) 4/33 (12%) 4/30 (13%) 3/31 (10%) | |FIRST INCIDENCE | |635 636 528 731 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.176N P=0.360N P=0.428N P=0.191N | |POLY 3 | |P=0.230N P=0.484N P=0.507N P=0.274N | |POLY 1.5 | |P=0.225N P=0.496N P=0.504N P=0.270N | |POLY 6 | |P=0.236N P=0.466N P=0.509N P=0.278N | |LOGISTIC REGRESSION| |P=0.216N P=0.498N P=0.501N P=0.250N | |COCH-ARM / FISHERS | |P=0.216N P=0.500N P=0.500N P=0.262N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 7.0% 7.2% 0.0% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 599 388 408 --- |--- --- 655 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.248N P=0.343 P=0.351 P=0.485N |P=0.691 (e) P=0.514 (e) | |POLY 3 | P=0.264N P=0.380 P=0.370 P=0.582N |P=0.718 (e) P=0.556 (e) | |POLY 1.5 | P=0.265N P=0.347 P=0.341 P=0.543N |P=0.705 (e) P=0.530 (e) | |POLY 6 | P=0.270N P=0.429 P=0.412 P=0.644N |P=0.740 (e) P=0.598 (e) | |LOGISTIC REGRESSION| P=0.369N P=0.211 P=0.268 P=0.564N |P=0.687 (e) P=0.508 (e) | |COCH-ARM / FISHERS | P=0.272N P=0.309 P=0.309 P=0.500N |P=0.689 (e) P=0.500 (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 32/50 (64%) 33/50 (66%) 30/50 (60%) 31/50 (62%) |19/50 (38%) 19/50 (38%) 18/50 (36%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 73.7% 71.1% 65.4% 66.4% |40.6% 40.1% 38.5% 27.8% | |TERMINAL (d) | 15/20 (75%) 15/23 (65%) 12/24 (50%) 12/23 (52%) |7/25 (28%) 11/33 (33%) 9/30 (30%) 4/31 (13%) | |FIRST INCIDENCE | 445 548 533 502 |519 627 528 562 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.265N P=0.357N P=0.229N P=0.285N |P=0.089N P=0.309N P=0.378N P=0.104N | |POLY 3 | P=0.239N P=0.494N P=0.265N P=0.299N |P=0.099N P=0.572N P=0.510N P=0.141N | |POLY 1.5 | P=0.296N P=0.572N P=0.330N P=0.378N |P=0.100N P=0.584 P=0.508N P=0.144N | |POLY 6 | P=0.190N P=0.389N P=0.191N P=0.222N |P=0.095N P=0.544N P=0.507N P=0.133N | |LOGISTIC REGRESSION| P=0.316N P=0.533N P=0.336N P=0.368N |P=0.099N P=0.578 P=0.503N P=0.144N | |COCH-ARM / FISHERS | P=0.399N P=0.500 P=0.418N P=0.500N |P=0.099N P=0.582N P=0.500N P=0.142N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.7% 0.0% 2.4% 4.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 0/23 (0%) 0/24 (0%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 673 --- 667 683 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.528N P=0.099N P=0.265N P=0.439N |(e) (e) (e) (e) | |POLY 3 | P=0.592N P=0.136N P=0.333N P=0.511N |(e) (e) (e) (e) | |POLY 1.5 | P=0.580N P=0.127N P=0.320N P=0.504N |(e) (e) (e) (e) | |POLY 6 | P=0.612N P=0.152N P=0.357N P=0.530N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.545N P=0.099N P=0.283N P=0.450N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.568N P=0.121N P=0.309N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 48/50 (96%) 48/50 (96%) 50/50 (100%)|43/50 (86%) 42/50 (84%) 48/50 (96%) 42/50 (84%) | |POLY-3 ADJUSTED (b)| 99.1% 98.1% 98.6% 100.0% |89.1% 87.1% 96.6% 88.2% | |TERMINAL (d) | 20/20 (100%) 23/23 (100%) 24/24 (100%) 23/23 (100%)|23/25 (92%) 28/33 (85%) 29/30 (97%) 29/31 (94%) | |FIRST INCIDENCE | 445 388 457 502 |541 627 506 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.387N P=0.235N P=0.246N P=0.348N |P=0.264N P=0.069N P=0.530N P=0.130N | |POLY 3 | P=0.391 P=0.749N P=0.903N P=0.957 |P=0.512 P=0.506N P=0.131 P=0.584N | |POLY 1.5 | P=0.252 P=0.681N P=0.781N P=0.556 |P=0.545 P=0.538N P=0.104 P=0.549N | |POLY 6 | P=0.782 P=0.973N P=1.000N P=1.000 |P=0.462 P=0.429N P=0.185 P=0.624N | |LOGISTIC REGRESSION| P=0.368 P=0.544N P=0.573N P=0.753 |P=0.541 P=0.438N P=0.074 P=0.511N | |COCH-ARM / FISHERS | P=0.162 P=0.691N P=0.691N P=0.247 |P=0.551N P=0.500N P=0.080 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 40/50 (80%) 38/50 (76%) 37/50 (74%) 37/50 (74%) |26/50 (52%) 24/50 (48%) 26/50 (52%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 87.6% 78.8% 78.1% 77.6% |54.9% 49.6% 53.9% 38.5% | |TERMINAL (d) | 17/20 (85%) 16/23 (70%) 16/24 (67%) 15/23 (65%) |10/25 (40%) 14/33 (42%) 13/30 (43%) 9/31 (29%) | |FIRST INCIDENCE | 445 388 408 502 |519 217 525 562 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.204N P=0.198N P=0.175N P=0.179N |P=0.066N P=0.169N P=0.404N P=0.052N | |POLY 3 | P=0.175N P=0.187N P=0.162N P=0.147N |P=0.078N P=0.378N P=0.548N P=0.081N | |POLY 1.5 | P=0.212N P=0.262N P=0.215N P=0.202N |P=0.076N P=0.398N P=0.564N P=0.081N | |POLY 6 | P=0.152N P=0.132N P=0.124N P=0.111N |P=0.078N P=0.350N P=0.521N P=0.078N | |LOGISTIC REGRESSION| P=0.240N P=0.316N P=0.247N P=0.197N |P=0.069N P=0.447N P=0.574 P=0.080N | |COCH-ARM / FISHERS | P=0.289N P=0.405N P=0.318N P=0.318N |P=0.070N P=0.421N P=0.579N P=0.079N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|48/50 (96%) 46/50 (92%) 49/50 (98%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 99.1% 100.0% 100.0% 100.0% |96.0% 93.3% 98.0% 97.5% | |TERMINAL (d) | 20/20 (100%) 23/23 (100%) 24/24 (100%) 23/23 (100%)|23/25 (92%) 30/33 (91%) 29/30 (97%) 30/31 (97%) | |FIRST INCIDENCE | 445 388 408 502 |519 217 506 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.361N P=0.325N P=0.343N P=0.348N |P=0.322N P=0.052N P=0.305N P=0.184N | |POLY 3 | P=0.702 P=0.957 P=0.957 P=0.957 |P=0.306 P=0.443N P=0.500 P=0.560 | |POLY 1.5 | P=0.284 P=0.556 P=0.556 P=0.556 |P=0.341 P=0.403N P=0.500 P=0.611 | |POLY 6 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.284 P=0.478N P=0.500 P=0.521 | |LOGISTIC REGRESSION| P=0.242 P=0.316 P=0.320 P=0.753 |P=0.421 P=0.334N (e) P=0.686 | |COCH-ARM / FISHERS | P=0.120 P=0.247 P=0.247 P=0.247 |P=0.420 P=0.339N P=0.500 P=0.691N | |=================================================================================================================================| (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).