TDMS Study 05110-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest NAPHTHALENE DATE: 08/15/00 EXPERIMENT: 05110 TEST: 02 TIME: 08:28:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 52904C PATHOLOGIST: GRUMBEIN, SONDRA CAS: 91-20-3 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY RATS/FINAL#3 REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest NAPHTHALENE DATE: 08/15/00 EXPERIMENT: 05110 TEST: 02 TIME: 08:28:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 52904C PATHOLOGIST: GRUMBEIN, SONDRA CAS: 91-20-3 Rats(FISCHER 344) ----------------------------- 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 THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Brain Clitoral/Preputial Gland Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Pituitary Gland Salivary Glands Spleen Testes Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest NAPHTHALENE DATE: 08/15/00 EXPERIMENT: 05110 TEST: 02 TIME: 08:28:13 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 52904C PATHOLOGIST: GRUMBEIN, SONDRA CAS: 91-20-3 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF NAPHTHALENE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Mammary Gland Fibroadenoma Nose Adenoma Neuroblastoma =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma Nose Neuroblastoma Thyroid Gland: C-Cell Carcinoma or Adenoma Uterus Polyp Stromal All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 1/48 (2%) 2/49 (4%) |1/49 (2%) 2/49 (4%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 2/41.10 0/38.97 1/38.90 2/37.46 |1/43.24 2/38.97 1/40.77 0/37.93 | |POLY-3 PERCENT (g) | 4.9% 0.0% 2.6% 5.3% |2.3% 5.1% 2.5% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 1/21 (5%) |1/28 (4%) 1/21 (5%) 1/28 (4%) 0/24 (0%) | |FIRST INCIDENCE | 657 --- 681 419 |734 (T) 663 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.379 P=0.273N P=0.544N P=0.636 |P=0.239N P=0.409 P=0.762 P=0.531N | |POLY 3 | P=0.405 P=0.249N P=0.519N P=0.661 |P=0.250N P=0.464 P=0.748 P=0.526N | |POLY 1.5 | P=0.411 P=0.244N P=0.513N P=0.674 |P=0.240N P=0.479 P=0.752 P=0.517N | |POLY 6 | P=0.398 P=0.256N P=0.529N P=0.644 |P=0.260N P=0.445 P=0.744 P=0.535N | |LOGISTIC REGRESSION| P=0.457 P=0.240N P=0.509N P=0.653N |P=0.246N P=0.446 P=0.762 (e) | |COCH-ARM / FISHERS | P=0.421 P=0.247N P=0.508N P=0.691N |P=0.220N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 7/49 (14%) 6/47 (13%) 8/49 (16%) |3/48 (6%) 0/49 (0%) 1/49 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 4/41.36 7/39.12 6/38.31 8/37.93 |3/42.67 0/38.70 1/41.00 2/37.93 | |POLY-3 PERCENT (g) | 9.7% 17.9% 15.7% 21.1% |7.0% 0.0% 2.4% 5.3% | |TERMINAL (d) | 1/24 (4%) 6/22 (27%) 4/23 (17%) 4/21 (19%) |2/28 (7%) 0/21 (0%) 0/28 (0%) 2/24 (8%) | |FIRST INCIDENCE | 639 695 681 562 |676 --- 671 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.139 P=0.214 P=0.329 P=0.120 |P=0.573 P=0.172N P=0.337N P=0.578N | |POLY 3 | P=0.151 P=0.226 P=0.320 P=0.133 |P=0.598N P=0.137N P=0.319N P=0.554N | |POLY 1.5 | P=0.167 P=0.242 P=0.332 P=0.148 |P=0.601N P=0.127N P=0.311N P=0.531N | |POLY 6 | P=0.136 P=0.205 P=0.302 P=0.119 |P=0.592N P=0.150N P=0.326N P=0.578N | |LOGISTIC REGRESSION| P=0.131 P=0.215 P=0.316 P=0.140 |P=0.569 P=0.148N P=0.313N P=0.586N | |COCH-ARM / FISHERS | P=0.198 P=0.262 P=0.344 P=0.178 |P=0.602N P=0.117N P=0.301N P=0.490N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 3/49 (6%) 1/47 (2%) 1/49 (2%) |0/48 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/40.88 3/38.97 1/38.01 1/36.65 |0/42.45 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 2.5% 7.7% 2.6% 2.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 3/22 (14%) 1/23 (4%) 1/21 (5%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 692 733 (T) 733 (T) 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.435N P=0.265 P=0.733 P=0.718 |(e) (e) (e) (e) | |POLY 3 | P=0.431N P=0.287 P=0.745 P=0.736 |(e) (e) (e) (e) | |POLY 1.5 | P=0.418N P=0.295 P=0.748 P=0.746 |(e) (e) (e) (e) | |POLY 6 | P=0.448N P=0.276 P=0.739 P=0.725 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.447N P=0.268 P=0.743 P=0.729 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.396N P=0.309 P=0.742 P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 10/49 (20%) 7/47 (15%) 8/49 (16%) |3/48 (6%) 0/49 (0%) 1/49 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 5/41.52 10/39.12 7/38.31 8/37.93 |3/42.67 0/38.70 1/41.00 2/37.93 | |POLY-3 PERCENT (g) | 12.0% 25.6% 18.3% 21.1% |7.0% 0.0% 2.4% 5.3% | |TERMINAL (d) | 1/24 (4%) 9/22 (41%) 5/23 (22%) 4/21 (19%) |2/28 (7%) 0/21 (0%) 0/28 (0%) 2/24 (8%) | |FIRST INCIDENCE | 639 695 681 562 |676 --- 671 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.310 P=0.094 P=0.329 P=0.189 |P=0.573 P=0.172N P=0.337N P=0.578N | |POLY 3 | P=0.331 P=0.098 P=0.321 P=0.215 |P=0.598N P=0.137N P=0.319N P=0.554N | |POLY 1.5 | P=0.359 P=0.112 P=0.335 P=0.237 |P=0.601N P=0.127N P=0.311N P=0.531N | |POLY 6 | P=0.301 P=0.081 P=0.298 P=0.194 |P=0.592N P=0.150N P=0.326N P=0.578N | |LOGISTIC REGRESSION| P=0.296 P=0.091 P=0.318 P=0.225 |P=0.569 P=0.148N P=0.313N P=0.586N | |COCH-ARM / FISHERS | P=0.409 P=0.131 P=0.350 P=0.276 |P=0.602N P=0.117N P=0.301N P=0.490N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/48 (6%) 0/49 (0%) 1/47 (2%) 1/49 (2%) |4/49 (8%) 7/47 (15%) 4/49 (8%) 2/48 (4%) | |POLY-3 RATE (b) | 3/39.72 0/38.97 1/38.14 1/36.65 |4/43.24 7/38.71 4/41.18 2/38.47 | |POLY-3 PERCENT (g) | 7.6% 0.0% 2.6% 2.7% |9.3% 18.1% 9.7% 5.2% | |TERMINAL (d) | 3/23 (13%) 0/22 (0%) 0/23 (0%) 1/21 (5%) |4/28 (14%) 4/21 (19%) 3/28 (11%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) --- 728 733 (T) |734 (T) 518 615 617 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.369N P=0.127N P=0.306N P=0.336N |P=0.161N P=0.138 P=0.638 P=0.417N | |POLY 3 | P=0.350N P=0.121N P=0.319N P=0.334N |P=0.168N P=0.198 P=0.617 P=0.392N | |POLY 1.5 | P=0.348N P=0.119N P=0.316N P=0.320N |P=0.157N P=0.214 P=0.626 P=0.378N | |POLY 6 | P=0.351N P=0.124N P=0.324N P=0.349N |P=0.176N P=0.181 P=0.611 P=0.405N | |LOGISTIC REGRESSION| P=0.374N (e) P=0.313N P=0.336N |P=0.155N P=0.185 P=0.601 P=0.386N | |COCH-ARM / FISHERS | P=0.344N P=0.117N P=0.316N P=0.301N |P=0.135N P=0.238 P=0.643N P=0.349N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/48 (6%) 1/49 (2%) 1/47 (2%) 1/49 (2%) |0/49 (0%) 1/47 (2%) 1/49 (2%) 1/48 (2%) | |POLY-3 RATE (b) | 3/40.40 1/39.12 1/38.64 1/37.34 |0/43.24 1/37.64 1/41.55 1/37.73 | |POLY-3 PERCENT (g) | 7.4% 2.6% 2.6% 2.7% |0.0% 2.7% 2.4% 2.7% | |TERMINAL (d) | 1/23 (4%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 1/21 (5%) 0/28 (0%) 1/24 (4%) | |FIRST INCIDENCE | 615 695 574 496 |--- 734 (T) 440 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.308N P=0.342N P=0.334N P=0.359N |P=0.389 P=0.443 P=0.500 P=0.469 | |POLY 3 | P=0.271N P=0.316N P=0.321N P=0.333N |P=0.359 P=0.472 P=0.492 P=0.473 | |POLY 1.5 | P=0.268N P=0.308N P=0.317N P=0.320N |P=0.373 P=0.480 P=0.495 P=0.481 | |POLY 6 | P=0.275N P=0.327N P=0.328N P=0.350N |P=0.344 P=0.463 P=0.490 P=0.464 | |LOGISTIC REGRESSION| P=0.218N P=0.298N P=0.307N P=0.247N |P=0.451 P=0.443 (e) P=0.469 | |COCH-ARM / FISHERS | P=0.261N P=0.301N P=0.316N P=0.301N |P=0.399 P=0.490 P=0.500 P=0.495 | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/48 (13%) 1/49 (2%) 2/47 (4%) 2/49 (4%) |4/49 (8%) 7/47 (15%) 5/49 (10%) 3/48 (6%) | |POLY-3 RATE (b) | 6/40.40 1/39.12 2/38.66 2/37.34 |4/43.24 7/38.71 5/41.97 3/38.47 | |POLY-3 PERCENT (g) | 14.9% 2.6% 5.2% 5.4% |9.3% 18.1% 11.9% 7.8% | |TERMINAL (d) | 4/23 (17%) 0/22 (0%) 0/23 (0%) 1/21 (5%) |4/28 (14%) 4/21 (19%) 3/28 (11%) 1/24 (4%) | |FIRST INCIDENCE | 615 695 574 496 |734 (T) 518 440 617 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.211N P=0.074N P=0.152N P=0.177N |P=0.304N P=0.138 P=0.493 P=0.589N | |POLY 3 | P=0.176N P=0.059N P=0.145N P=0.157N |P=0.316N P=0.198 P=0.481 P=0.564N | |POLY 1.5 | P=0.173N P=0.056N P=0.142N P=0.145N |P=0.301N P=0.214 P=0.488 P=0.547N | |POLY 6 | P=0.178N P=0.064N P=0.150N P=0.172N |P=0.330N P=0.181 P=0.478 P=0.579N | |LOGISTIC REGRESSION| P=0.176N P=0.061N P=0.143N P=0.141N |P=0.275N P=0.185 P=0.506 P=0.572N | |COCH-ARM / FISHERS | P=0.170N P=0.053N P=0.141N P=0.127N |P=0.265N P=0.238 P=0.500 P=0.512N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Heart | | Schwannoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/49 (2%) 2/48 (4%) 0/49 (0%) |0/49 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 0/40.72 1/38.97 2/38.70 0/36.65 |0/43.24 0/38.70 1/40.77 0/37.93 | |POLY-3 PERCENT (g) | 0.0% 2.6% 5.2% 0.0% |0.0% 0.0% 2.5% 0.0% | |TERMINAL (d) | 0/24 (0%) 1/22 (5%) 2/23 (9%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 0/24 (0%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) --- |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.628N P=0.483 P=0.228 (e) |P=0.664 (e) P=0.500 (e) | |POLY 3 | P=0.640N P=0.491 P=0.225 (e) |P=0.625 (e) P=0.488 (e) | |POLY 1.5 | P=0.625N P=0.495 P=0.229 (e) |P=0.640 (e) P=0.493 (e) | |POLY 6 | P=0.620 P=0.486 P=0.220 (e) |P=0.610 (e) P=0.485 (e) | |LOGISTIC REGRESSION| (e) P=0.483 P=0.228 (e) |(e) (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.601N P=0.500 P=0.242 (e) |P=0.669 (e) P=0.500 (e) | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 5/49 (10%) 3/48 (6%) 2/49 (4%) |1/49 (2%) 1/49 (2%) 1/49 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 2/41.10 5/39.18 3/39.67 2/36.65 |1/43.46 1/38.70 1/41.06 1/37.93 | |POLY-3 PERCENT (g) | 4.9% 12.8% 7.6% 5.5% |2.3% 2.6% 2.4% 2.6% | |TERMINAL (d) | 1/24 (4%) 4/22 (18%) 1/23 (4%) 2/21 (10%) |0/28 (0%) 1/21 (5%) 0/28 (0%) 1/24 (4%) | |FIRST INCIDENCE | 624 680 560 733 (T) |677 734 (T) 653 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.435N P=0.187 P=0.467 P=0.641 |P=0.597 P=0.708 P=0.731 P=0.719 | |POLY 3 | P=0.432N P=0.195 P=0.484 P=0.653 |P=0.592 P=0.734 P=0.748 P=0.730 | |POLY 1.5 | P=0.410N P=0.204 P=0.488 P=0.669 |P=0.604 P=0.746 P=0.753 P=0.741 | |POLY 6 | P=0.458N P=0.183 P=0.477 P=0.633 |P=0.580 P=0.719 P=0.745 P=0.717 | |LOGISTIC REGRESSION| P=0.419N P=0.188 P=0.499 P=0.647 |P=0.606 P=0.737 P=0.743N P=0.734 | |COCH-ARM / FISHERS | P=0.374N P=0.218 P=0.490 P=0.691N |P=0.630 P=0.753N P=0.753N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 4/49 (8%) 4/48 (8%) 4/49 (8%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 4/41.08 4/38.97 4/39.19 4/36.75 |1/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 9.7% 10.3% 10.2% 10.9% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/24 (8%) 4/22 (18%) 2/23 (9%) 3/21 (14%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 677 733 (T) 650 707 |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.492 P=0.593 P=0.592 P=0.551 |P=0.336N P=0.557N P=0.500N P=0.531N | |POLY 3 | P=0.504 P=0.615 P=0.618 P=0.582 |P=0.309N P=0.522N P=0.512N P=0.526N | |POLY 1.5 | P=0.527 P=0.627 P=0.625 P=0.606 |P=0.318N P=0.513N P=0.507N P=0.517N | |POLY 6 | P=0.477 P=0.596 P=0.607 P=0.553 |P=0.300N P=0.534N P=0.515N P=0.535N | |LOGISTIC REGRESSION| P=0.475 P=0.592 P=0.610 P=0.548 |P=0.336N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.566 P=0.643N P=0.631 P=0.643N |P=0.331N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/49 (12%) 9/49 (18%) 7/48 (15%) 6/49 (12%) |2/49 (4%) 1/49 (2%) 1/49 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 6/41.46 9/39.18 7/40.15 6/36.75 |2/43.46 1/38.70 1/41.06 1/37.93 | |POLY-3 PERCENT (g) | 14.5% 23.0% 17.4% 16.3% |4.6% 2.6% 2.4% 2.6% | |TERMINAL (d) | 3/24 (13%) 8/22 (36%) 3/23 (13%) 5/21 (24%) |1/28 (4%) 1/21 (5%) 0/28 (0%) 1/24 (4%) | |FIRST INCIDENCE | 624 680 560 707 |677 734 (T) 653 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.516N P=0.228 P=0.439 P=0.507 |P=0.454N P=0.587N P=0.530N P=0.560N | |POLY 3 | P=0.504N P=0.242 P=0.475 P=0.535 |P=0.437N P=0.540N P=0.520N P=0.547N | |POLY 1.5 | P=0.470N P=0.262 P=0.480 P=0.569 |P=0.433N P=0.523N P=0.513N P=0.531N | |POLY 6 | P=0.546N P=0.215 P=0.465 P=0.492 |P=0.440N P=0.563N P=0.526N P=0.565N | |LOGISTIC REGRESSION| P=0.521N P=0.225 P=0.477 P=0.505 |P=0.456N P=0.564N P=0.497N P=0.562N | |COCH-ARM / FISHERS | P=0.415N P=0.288 P=0.484 P=0.620N |P=0.422N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/49 (0%) 0/48 (0%) 3/49 (6%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/41.10 0/38.97 0/38.70 3/36.65 |0/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 8.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 3/21 (14%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 624 --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.062 P=0.515N P=0.526N P=0.255 |(e) (e) (e) (e) | |POLY 3 | P=0.070 P=0.511N P=0.512N P=0.264 |(e) (e) (e) (e) | |POLY 1.5 | P=0.072 P=0.506N P=0.508N P=0.280 |(e) (e) (e) (e) | |POLY 6 | P=0.068 P=0.517N P=0.518N P=0.247 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.061 P=0.483N P=0.499N P=0.256 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.076 P=0.500N P=0.505N P=0.309 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/48 (0%) 4/49 (8%) |0/49 (0%) 1/49 (2%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 2/41.10 0/38.97 0/38.70 4/37.00 |0/43.24 1/38.92 1/40.77 0/37.93 | |POLY-3 PERCENT (g) | 4.9% 0.0% 0.0% 10.8% |0.0% 2.6% 2.5% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/22 (0%) 0/23 (0%) 3/21 (14%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 0/24 (0%) | |FIRST INCIDENCE | 624 --- --- 632 |--- 677 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.068 P=0.258N P=0.259N P=0.271 |P=0.582N P=0.465 P=0.500 (e) | |POLY 3 | P=0.080 P=0.249N P=0.250N P=0.289 |P=0.596N P=0.479 P=0.488 (e) | |POLY 1.5 | P=0.082 P=0.244N P=0.246N P=0.307 |P=0.584N P=0.488 P=0.493 (e) | |POLY 6 | P=0.079 P=0.256N P=0.257N P=0.269 |P=0.609N P=0.468 P=0.485 (e) | |LOGISTIC REGRESSION| P=0.071 P=0.238N P=0.242N P=0.285 |P=0.583N P=0.509 P=0.500 (e) | |COCH-ARM / FISHERS | P=0.087 P=0.247N P=0.253N P=0.339 |P=0.562N P=0.500 P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/48 (0%) 4/49 (8%) |0/49 (0%) 1/49 (2%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 2/41.10 0/38.97 0/38.70 4/37.00 |0/43.24 1/38.92 1/40.77 0/37.93 | |POLY-3 PERCENT (g) | 4.9% 0.0% 0.0% 10.8% |0.0% 2.6% 2.5% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/22 (0%) 0/23 (0%) 3/21 (14%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 0/24 (0%) | |FIRST INCIDENCE | 624 --- --- 632 |--- 677 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.068 P=0.258N P=0.259N P=0.271 |P=0.582N P=0.465 P=0.500 (e) | |POLY 3 | P=0.080 P=0.249N P=0.250N P=0.289 |P=0.596N P=0.479 P=0.488 (e) | |POLY 1.5 | P=0.082 P=0.244N P=0.246N P=0.307 |P=0.584N P=0.488 P=0.493 (e) | |POLY 6 | P=0.079 P=0.256N P=0.257N P=0.269 |P=0.609N P=0.468 P=0.485 (e) | |LOGISTIC REGRESSION| P=0.071 P=0.238N P=0.242N P=0.285 |P=0.583N P=0.509 P=0.500 (e) | |COCH-ARM / FISHERS | P=0.087 P=0.247N P=0.253N P=0.339 |P=0.562N P=0.500 P=0.500 (e) | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 1/48 (2%) 0/49 (0%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 2/40.72 0/38.97 1/38.70 0/36.65 |1/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 4.9% 0.0% 2.6% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/24 (8%) 0/22 (0%) 1/23 (4%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) --- |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.241N P=0.257N P=0.515N P=0.267N |P=0.336N P=0.557N P=0.500N P=0.531N | |POLY 3 | P=0.230N P=0.247N P=0.518N P=0.261N |P=0.309N P=0.522N P=0.512N P=0.526N | |POLY 1.5 | P=0.228N P=0.243N P=0.512N P=0.252N |P=0.318N P=0.513N P=0.507N P=0.517N | |POLY 6 | P=0.232N P=0.252N P=0.526N P=0.271N |P=0.300N P=0.534N P=0.515N P=0.535N | |LOGISTIC REGRESSION| P=0.241N (e) P=0.515N (e) |P=0.336N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.224N P=0.247N P=0.508N P=0.247N |P=0.331N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 3/49 (6%) 0/48 (0%) 0/49 (0%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/40.72 3/39.44 0/38.70 0/36.65 |0/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 0.0% 7.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 2/22 (9%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 593 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.246N P=0.110 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.242N P=0.112 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.233N P=0.115 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.252N P=0.109 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.234N P=0.116 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.224N P=0.121 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 3/49 (6%) 1/48 (2%) 0/49 (0%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 2/40.72 3/39.44 1/38.70 0/36.65 |1/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 4.9% 7.6% 2.6% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/24 (8%) 2/22 (9%) 1/23 (4%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) 593 733 (T) --- |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.102N P=0.464 P=0.515N P=0.267N |P=0.336N P=0.557N P=0.500N P=0.531N | |POLY 3 | P=0.102N P=0.485 P=0.518N P=0.261N |P=0.309N P=0.522N P=0.512N P=0.526N | |POLY 1.5 | P=0.097N P=0.491 P=0.512N P=0.252N |P=0.318N P=0.513N P=0.507N P=0.517N | |POLY 6 | P=0.108N P=0.478 P=0.526N P=0.271N |P=0.300N P=0.534N P=0.515N P=0.535N | |LOGISTIC REGRESSION| P=0.105N P=0.474 P=0.515N (e) |P=0.336N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.088N P=0.500 P=0.508N P=0.247N |P=0.331N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/49 (2%) 1/49 (2%) 0/49 (0%) |3/49 (6%) 5/49 (10%) 3/49 (6%) 3/49 (6%) | |POLY-3 RATE (b) | 1/40.72 1/38.97 1/38.70 0/36.65 |3/43.24 5/40.17 3/41.44 3/39.01 | |POLY-3 PERCENT (g) | 2.5% 2.6% 2.6% 0.0% |6.9% 12.5% 7.2% 7.7% | |TERMINAL (d) | 1/24 (4%) 1/22 (5%) 1/23 (4%) 0/21 (0%) |3/28 (11%) 1/21 (5%) 1/28 (4%) 1/24 (4%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) --- |734 (T) 577 587 503 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.327N P=0.743 P=0.753 P=0.527N |P=0.474N P=0.248 P=0.654 P=0.593 | |POLY 3 | P=0.327N P=0.751 P=0.750 P=0.521N |P=0.478N P=0.315 P=0.643 P=0.614 | |POLY 1.5 | P=0.320N P=0.755 P=0.753 P=0.513N |P=0.462N P=0.332 P=0.649 P=0.630 | |POLY 6 | P=0.335N P=0.746 P=0.745 P=0.530N |P=0.490N P=0.297 P=0.641 P=0.600 | |LOGISTIC REGRESSION| P=0.327N P=0.743 P=0.753 (e) |P=0.393N P=0.370 P=0.647 P=0.663N | |COCH-ARM / FISHERS | P=0.306N P=0.753N P=0.753N P=0.500N |P=0.428N P=0.357 P=0.661N P=0.661N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 3/49 (6%) |17/49 (35%) 20/49 (41%) 18/49 (37%) 14/49 (29%) | |POLY-3 RATE (b) | 0/40.72 0/38.97 0/38.70 3/36.65 |17/44.18 20/40.73 18/43.72 14/38.74 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 8.2% |38.5% 49.1% 41.2% 36.1% | |TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 3/21 (14%) |12/28 (43%) 12/21 (57%) 10/28 (36%) 10/24 (42%) | |FIRST INCIDENCE | --- --- --- 733 (T) |625 581 440 625 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008 ** (e) (e) P=0.096 |P=0.302N P=0.084 P=0.454 P=0.562N | |POLY 3 | P=0.009 ** (e) (e) P=0.100 |P=0.319N P=0.216 P=0.484 P=0.503N | |POLY 1.5 | P=0.009 ** (e) (e) P=0.107 |P=0.277N P=0.264 P=0.486 P=0.441N | |POLY 6 | P=0.009 ** (e) (e) P=0.093 |P=0.361N P=0.166 P=0.496 P=0.570N | |LOGISTIC REGRESSION| (e) (e) (e) P=0.096 |P=0.322N P=0.133 P=0.446 P=0.590 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) P=0.121 |P=0.198N P=0.339 P=0.500 P=0.332N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/49 (2%) 1/49 (2%) 3/49 (6%) |18/49 (37%) 24/49 (49%) 19/49 (39%) 17/49 (35%) | |POLY-3 RATE (b) | 1/40.72 1/38.97 1/38.70 3/36.65 |18/44.18 24/42.19 19/43.72 17/39.82 | |POLY-3 PERCENT (g) | 2.5% 2.6% 2.6% 8.2% |40.7% 56.9% 43.5% 42.7% | |TERMINAL (d) | 1/24 (4%) 1/22 (5%) 1/23 (4%) 3/21 (14%) |13/28 (46%) 12/21 (57%) 11/28 (39%) 11/24 (46%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |625 577 440 503 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.132 P=0.743 P=0.753 P=0.255 |P=0.380N P=0.027 * P=0.455 P=0.418 | |POLY 3 | P=0.140 P=0.751 P=0.750 P=0.267 |P=0.379N P=0.092 P=0.483 P=0.517 | |POLY 1.5 | P=0.147 P=0.755 P=0.753 P=0.282 |P=0.337N P=0.113 P=0.485 P=0.566 | |POLY 6 | P=0.132 P=0.746 P=0.745 P=0.252 |P=0.417N P=0.074 P=0.496 P=0.468 | |LOGISTIC REGRESSION| P=0.132 P=0.743 P=0.753 P=0.255 |P=0.377N P=0.056 P=0.434 P=0.427 | |COCH-ARM / FISHERS | P=0.160 P=0.753N P=0.753N P=0.309 |P=0.252N P=0.154 P=0.500 P=0.500N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Nose | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 6/49 (12%) 8/48 (17%) 15/48 (31%) |0/49 (0%) 0/49 (0%) 4/49 (8%) 2/49 (4%) | |POLY-3 RATE (b) | 0/40.72 6/39.16 8/38.89 15/39.38 |0/43.24 0/38.70 4/40.82 2/38.50 | |POLY-3 PERCENT (g) | 0.0% 15.3% 20.6% 38.1% |0.0% 0.0% 9.8% 5.2% | |TERMINAL (d) | 0/24 (0%) 5/22 (23%) 7/23 (30%) 7/21 (33%) |0/28 (0%) 0/21 (0%) 3/28 (11%) 1/24 (4%) | |FIRST INCIDENCE | --- 684 685 552 |--- --- 721 555 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.012 * P=0.003 ** P<0.001 ** |P=0.078 (e) P=0.063 P=0.208 | |POLY 3 | P<0.001 ** P=0.013 * P=0.003 ** P<0.001 ** |P=0.066 (e) P=0.053 P=0.212 | |POLY 1.5 | P<0.001 ** P=0.014 * P=0.003 ** P<0.001 ** |P=0.071 (e) P=0.056 P=0.220 | |POLY 6 | P<0.001 ** P=0.011 * P=0.002 ** P<0.001 ** |P=0.062 (e) P=0.050 P=0.204 | |LOGISTIC REGRESSION| P<0.001 ** P=0.011 * P=0.003 ** P<0.001 ** |P=0.073 (e) P=0.054 P=0.262 | |COCH-ARM / FISHERS | P<0.001 ** P=0.013 * P=0.003 ** P<0.001 ** |P=0.087 (e) P=0.059 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Nose | | Neuroblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 4/48 (8%) 3/48 (6%) |0/49 (0%) 2/49 (4%) 3/49 (6%) 12/49 (24%) | |POLY-3 RATE (b) | 0/40.72 0/38.97 4/39.71 3/38.79 |0/43.24 2/38.96 3/41.86 12/42.52 | |POLY-3 PERCENT (g) | 0.0% 0.0% 10.1% 7.7% |0.0% 5.1% 7.2% 28.2% | |TERMINAL (d) | 0/24 (0%) 0/22 (0%) 2/23 (9%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 3/24 (13%) | |FIRST INCIDENCE | --- --- 433 399 |--- 679 480 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.028 * (e) P=0.060 P=0.119 |P<0.001 ** P=0.185 P=0.114 P<0.001 ** | |POLY 3 | P=0.027 * (e) P=0.056 P=0.109 |P<0.001 ** P=0.214 P=0.112 P<0.001 ** | |POLY 1.5 | P=0.028 * (e) P=0.057 P=0.112 |P<0.001 ** P=0.224 P=0.115 P<0.001 ** | |POLY 6 | P=0.026 * (e) P=0.054 P=0.106 |P<0.001 ** P=0.203 P=0.111 P<0.001 ** | |LOGISTIC REGRESSION| P=0.051 (e) P=0.062 P=0.201 |P<0.001 ** P=0.213 P=0.178 P<0.001 ** | |COCH-ARM / FISHERS | P=0.030 * (e) P=0.056 P=0.117 |P<0.001 ** P=0.247 P=0.121 P<0.001 ** | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 2/49 (4%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | |2/43.46 2/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | |4.6% 5.2% 0.0% 0.0% | |TERMINAL (d) | |1/28 (4%) 2/21 (10%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | |677 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.083N P=0.598 P=0.252N P=0.281N | |POLY 3 | |P=0.082N P=0.652 P=0.251N P=0.269N | |POLY 1.5 | |P=0.080N P=0.670 P=0.246N P=0.257N | |POLY 6 | |P=0.084N P=0.627 P=0.257N P=0.281N | |LOGISTIC REGRESSION| |P=0.088N P=0.620 P=0.248N P=0.266N | |COCH-ARM / FISHERS | |P=0.076N P=0.691N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/49 (0%) 0/48 (0%) 2/49 (4%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/40.72 0/38.97 0/38.70 2/36.65 |0/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 5.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/22 (0%) 0/23 (0%) 2/21 (10%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.200 P=0.517N P=0.508N P=0.453 |(e) (e) (e) (e) | |POLY 3 | P=0.214 P=0.509N P=0.510N P=0.463 |(e) (e) (e) (e) | |POLY 1.5 | P=0.217 P=0.505N P=0.507N P=0.477 |(e) (e) (e) (e) | |POLY 6 | P=0.211 P=0.514N P=0.515N P=0.448 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.200 (e) (e) P=0.453 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.223 P=0.500N P=0.505N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/49 (0%) 0/48 (0%) 3/49 (6%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/40.72 0/38.97 0/38.70 3/36.92 |0/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 8.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/22 (0%) 0/23 (0%) 2/21 (10%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) --- --- 660 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.061 P=0.517N P=0.508N P=0.252 |(e) (e) (e) (e) | |POLY 3 | P=0.070 P=0.509N P=0.510N P=0.270 |(e) (e) (e) (e) | |POLY 1.5 | P=0.072 P=0.505N P=0.507N P=0.283 |(e) (e) (e) (e) | |POLY 6 | P=0.069 P=0.514N P=0.515N P=0.257 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.059 (e) (e) P=0.247 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.076 P=0.500N P=0.505N P=0.309 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 31/49 (63%) 31/49 (63%) 35/47 (74%) 29/49 (59%) |23/49 (47%) 27/49 (55%) 24/49 (49%) 20/48 (42%) | |POLY-3 RATE (b) | 31/45.41 31/45.26 35/44.33 29/43.25 |23/46.45 27/44.09 24/44.27 20/41.56 | |POLY-3 PERCENT (g) | 68.3% 68.5% 79.0% 67.1% |49.5% 61.2% 54.2% 48.1% | |TERMINAL (d) | 15/24 (63%) 17/22 (77%) 17/23 (74%) 12/21 (57%) |12/28 (43%) 14/21 (67%) 14/28 (50%) 11/24 (46%) | |FIRST INCIDENCE | 516 390 489 469 |509 509 581 482 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.374 P=0.415 P=0.222 P=0.409 |P=0.340N P=0.070 P=0.429 P=0.520 | |POLY 3 | P=0.517 P=0.583 P=0.173 P=0.543N |P=0.335N P=0.176 P=0.405 P=0.534N | |POLY 1.5 | P=0.529N P=0.581N P=0.173 P=0.501N |P=0.293N P=0.211 P=0.437 P=0.481N | |POLY 6 | P=0.494 P=0.529 P=0.163 P=0.587N |P=0.386N P=0.140 P=0.386 P=0.581 | |LOGISTIC REGRESSION| P=0.495N P=0.568 P=0.158 P=0.520N |P=0.239N P=0.288 P=0.487 P=0.401N | |COCH-ARM / FISHERS | P=0.426N P=0.583N P=0.168 P=0.418N |P=0.211N P=0.272 P=0.500 P=0.375N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 31/49 (63%) 31/49 (63%) 35/47 (74%) 29/49 (59%) |23/49 (47%) 27/49 (55%) 25/49 (51%) 20/48 (42%) | |POLY-3 RATE (b) | 31/45.41 31/45.26 35/44.33 29/43.25 |23/46.45 27/44.09 25/44.32 20/41.56 | |POLY-3 PERCENT (g) | 68.3% 68.5% 79.0% 67.1% |49.5% 61.2% 56.4% 48.1% | |TERMINAL (d) | 15/24 (63%) 17/22 (77%) 17/23 (74%) 12/21 (57%) |12/28 (43%) 14/21 (67%) 14/28 (50%) 11/24 (46%) | |FIRST INCIDENCE | 516 390 489 469 |509 509 581 482 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.374 P=0.415 P=0.222 P=0.409 |P=0.353N P=0.070 P=0.365 P=0.520 | |POLY 3 | P=0.517 P=0.583 P=0.173 P=0.543N |P=0.351N P=0.176 P=0.325 P=0.534N | |POLY 1.5 | P=0.529N P=0.581N P=0.173 P=0.501N |P=0.307N P=0.211 P=0.356 P=0.481N | |POLY 6 | P=0.494 P=0.529 P=0.163 P=0.587N |P=0.404N P=0.140 P=0.308 P=0.581 | |LOGISTIC REGRESSION| P=0.495N P=0.568 P=0.158 P=0.520N |P=0.252N P=0.288 P=0.402 P=0.401N | |COCH-ARM / FISHERS | P=0.426N P=0.583N P=0.168 P=0.418N |P=0.220N P=0.272 P=0.420 P=0.375N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/49 (2%) 2/49 (4%) 0/49 (0%) |0/49 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 0/40.72 1/39.17 2/38.90 0/36.65 |0/43.24 0/38.70 1/40.77 0/37.93 | |POLY-3 PERCENT (g) | 0.0% 2.6% 5.1% 0.0% |0.0% 0.0% 2.5% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/22 (0%) 1/23 (4%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 0/24 (0%) | |FIRST INCIDENCE | --- 681 681 --- |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.635N P=0.487 P=0.228 (e) |P=0.664 (e) P=0.500 (e) | |POLY 3 | P=0.640N P=0.492 P=0.227 (e) |P=0.625 (e) P=0.488 (e) | |POLY 1.5 | P=0.625N P=0.495 P=0.230 (e) |P=0.640 (e) P=0.493 (e) | |POLY 6 | P=0.621 P=0.488 P=0.222 (e) |P=0.610 (e) P=0.485 (e) | |LOGISTIC REGRESSION| P=0.627N P=0.498 P=0.222 (e) |(e) (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.600N P=0.500 P=0.247 (e) |P=0.669 (e) P=0.500 (e) | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 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) | 4/49 (8%) 5/49 (10%) 4/49 (8%) 2/49 (4%) |1/49 (2%) 0/49 (0%) 1/49 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 4/40.98 5/39.91 4/39.10 2/37.04 |1/43.24 0/38.70 1/40.77 1/38.13 | |POLY-3 PERCENT (g) | 9.8% 12.5% 10.2% 5.4% |2.3% 0.0% 2.5% 2.6% | |TERMINAL (d) | 2/24 (8%) 2/22 (9%) 2/23 (9%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 1/28 (4%) 0/24 (0%) | |FIRST INCIDENCE | 692 567 681 659 |734 (T) --- 734 (T) 680 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.440 P=0.596 P=0.427N |P=0.486 P=0.557N P=0.762 P=0.722 | |POLY 3 | P=0.251N P=0.483 P=0.618 P=0.384N |P=0.479 P=0.522N P=0.748 P=0.732 | |POLY 1.5 | P=0.235N P=0.490 P=0.625 P=0.367N |P=0.485 P=0.513N P=0.752 P=0.742 | |POLY 6 | P=0.269N P=0.475 P=0.608 P=0.403N |P=0.475 P=0.534N P=0.744 P=0.722 | |LOGISTIC REGRESSION| P=0.246N P=0.476 P=0.602 P=0.398N |P=0.468 (e) P=0.762 P=0.732 | |COCH-ARM / FISHERS | P=0.206N P=0.500 P=0.643N P=0.339N |P=0.500 P=0.500N P=0.753N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/49 (10%) 2/49 (4%) 2/49 (4%) 2/49 (4%) |0/49 (0%) 0/49 (0%) 1/49 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 5/41.47 2/38.97 2/38.70 2/36.65 |0/43.24 0/38.70 1/41.15 1/37.93 | |POLY-3 PERCENT (g) | 12.1% 5.1% 5.2% 5.5% |0.0% 0.0% 2.4% 2.6% | |TERMINAL (d) | 4/24 (17%) 2/22 (9%) 2/23 (9%) 2/21 (10%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 1/24 (4%) | |FIRST INCIDENCE | 460 733 (T) 733 (T) 733 (T) |--- --- 624 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.240N P=0.247N P=0.231N P=0.266N |P=0.208 (e) P=0.476 P=0.469 | |POLY 3 | P=0.233N P=0.240N P=0.243N P=0.268N |P=0.195 (e) P=0.490 P=0.474 | |POLY 1.5 | P=0.224N P=0.230N P=0.235N P=0.248N |P=0.203 (e) P=0.494 P=0.483 | |POLY 6 | P=0.242N P=0.253N P=0.256N P=0.290N |P=0.187 (e) P=0.488 P=0.465 | |LOGISTIC REGRESSION| P=0.254N P=0.230N P=0.233N P=0.255N |P=0.215 (e) P=0.567 P=0.469 | |COCH-ARM / FISHERS | P=0.208N P=0.218N P=0.218N P=0.218N |P=0.219 (e) P=0.500 P=0.500 | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 7/49 (14%) 5/49 (10%) 4/49 (8%) 4/49 (8%) |1/49 (2%) 0/49 (0%) 1/49 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 7/41.68 5/39.24 4/38.70 4/37.61 |1/43.24 0/38.70 1/41.15 2/38.12 | |POLY-3 PERCENT (g) | 16.8% 12.7% 10.3% 10.6% |2.3% 0.0% 2.4% 5.3% | |TERMINAL (d) | 5/24 (21%) 3/22 (14%) 4/23 (17%) 2/21 (10%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 1/24 (4%) | |FIRST INCIDENCE | 460 684 733 (T) 575 |734 (T) --- 624 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.283N P=0.441N P=0.285N P=0.348N |P=0.204 P=0.557N P=0.747 P=0.439 | |POLY 3 | P=0.258N P=0.421N P=0.302N P=0.320N |P=0.207 P=0.522N P=0.750 P=0.456 | |POLY 1.5 | P=0.246N P=0.404N P=0.289N P=0.299N |P=0.210 P=0.513N P=0.753 P=0.471 | |POLY 6 | P=0.272N P=0.442N P=0.324N P=0.343N |P=0.205 P=0.534N P=0.747 P=0.441 | |LOGISTIC REGRESSION| P=0.273N P=0.411N P=0.294N P=0.282N |P=0.203 (e) P=0.755N P=0.435 | |COCH-ARM / FISHERS | P=0.220N P=0.380N P=0.262N P=0.262N |P=0.220 P=0.500N P=0.753N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/49 (4%) 2/49 (4%) 0/49 (0%) 2/49 (4%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 2/40.93 2/39.24 0/38.70 2/37.61 |0/43.24 0/38.70 0/40.77 1/38.12 | |POLY-3 PERCENT (g) | 4.9% 5.1% 0.0% 5.3% |0.0% 0.0% 0.0% 2.6% | |TERMINAL (d) | 1/24 (4%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 678 684 --- 575 |--- --- --- 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.591N P=0.658 P=0.255N P=0.632 |P=0.177 (e) (e) P=0.455 | |POLY 3 | P=0.551N P=0.679 P=0.249N P=0.664 |P=0.181 (e) (e) P=0.475 | |POLY 1.5 | P=0.546N P=0.685 P=0.246N P=0.674 |P=0.184 (e) (e) P=0.483 | |POLY 6 | P=0.558N P=0.672 P=0.256N P=0.653 |P=0.178 (e) (e) P=0.467 | |LOGISTIC REGRESSION| P=0.535N P=0.678 P=0.251N P=0.675N |P=0.185 (e) (e) P=0.494 | |COCH-ARM / FISHERS | P=0.536N P=0.691N P=0.247N P=0.691N |P=0.191 (e) (e) P=0.500 | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/49 (4%) 3/49 (6%) 2/49 (4%) 2/49 (4%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 2/40.93 3/39.24 2/38.70 2/37.61 |1/43.24 0/38.70 0/40.77 1/38.12 | |POLY-3 PERCENT (g) | 4.9% 7.7% 5.2% 5.3% |2.3% 0.0% 0.0% 2.6% | |TERMINAL (d) | 1/24 (4%) 1/22 (5%) 2/23 (9%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 678 684 733 (T) 575 |734 (T) --- --- 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.562N P=0.459 P=0.674 P=0.632 |P=0.545 P=0.557N P=0.500N P=0.718 | |POLY 3 | P=0.535N P=0.481 P=0.674 P=0.664 |P=0.557 P=0.522N P=0.512N P=0.732 | |POLY 1.5 | P=0.523N P=0.489 P=0.681 P=0.674 |P=0.557 P=0.513N P=0.507N P=0.742 | |POLY 6 | P=0.548N P=0.470 P=0.664 P=0.653 |P=0.558 P=0.534N P=0.515N P=0.722 | |LOGISTIC REGRESSION| P=0.531N P=0.471 P=0.663 P=0.675N |P=0.539 (e) (e) P=0.730 | |COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.691N P=0.691N |P=0.562 P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/49 (8%) 3/49 (6%) 2/49 (4%) 2/49 (4%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 4/40.98 3/39.51 2/38.90 2/37.04 |0/43.24 0/38.70 0/40.77 1/38.13 | |POLY-3 PERCENT (g) | 9.8% 7.6% 5.1% 5.4% |0.0% 0.0% 0.0% 2.6% | |TERMINAL (d) | 2/24 (8%) 2/22 (9%) 1/23 (4%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 692 567 681 659 |--- --- --- 680 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.308N P=0.561N P=0.382N P=0.427N |P=0.182 (e) (e) P=0.462 | |POLY 3 | P=0.280N P=0.520N P=0.360N P=0.384N |P=0.181 (e) (e) P=0.475 | |POLY 1.5 | P=0.270N P=0.511N P=0.354N P=0.367N |P=0.184 (e) (e) P=0.483 | |POLY 6 | P=0.291N P=0.533N P=0.372N P=0.403N |P=0.178 (e) (e) P=0.467 | |LOGISTIC REGRESSION| P=0.288N P=0.525N P=0.373N P=0.398N |P=0.187 (e) (e) P=0.498 | |COCH-ARM / FISHERS | P=0.249N P=0.500N P=0.339N P=0.339N |P=0.191 (e) (e) P=0.500 | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Lipoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/49 (2%) 3/49 (6%) 0/49 (0%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/40.81 1/38.97 3/38.79 0/36.65 |0/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 2.5% 2.6% 7.7% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 1/22 (5%) 2/23 (9%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 709 733 (T) 710 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.461N P=0.733 P=0.284 P=0.539N |(e) (e) (e) (e) | |POLY 3 | P=0.467N P=0.751 P=0.286 P=0.521N |(e) (e) (e) (e) | |POLY 1.5 | P=0.450N P=0.755 P=0.292 P=0.513N |(e) (e) (e) (e) | |POLY 6 | P=0.486N P=0.745 P=0.277 P=0.531N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.472N P=0.742 P=0.270 P=0.529N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.422N P=0.753N P=0.309 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/49 (2%) 2/49 (4%) 0/49 (0%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/40.72 1/38.97 2/38.70 0/36.65 |1/43.24 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 0.0% 2.6% 5.2% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 1/22 (5%) 2/23 (9%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) --- |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.628N P=0.483 P=0.228 (e) |P=0.336N P=0.557N P=0.500N P=0.531N | |POLY 3 | P=0.639N P=0.491 P=0.225 (e) |P=0.309N P=0.522N P=0.512N P=0.526N | |POLY 1.5 | P=0.625N P=0.495 P=0.229 (e) |P=0.318N P=0.513N P=0.507N P=0.517N | |POLY 6 | P=0.622 P=0.486 P=0.220 (e) |P=0.300N P=0.534N P=0.515N P=0.535N | |LOGISTIC REGRESSION| (e) P=0.483 P=0.228 (e) |P=0.336N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.600N P=0.500 P=0.247 (e) |P=0.331N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/49 (8%) 4/49 (8%) 2/49 (4%) 2/49 (4%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 4/40.98 4/39.71 2/38.90 2/37.04 |1/43.24 0/38.70 0/40.77 1/38.13 | |POLY-3 PERCENT (g) | 9.8% 10.1% 5.1% 5.4% |2.3% 0.0% 0.0% 2.6% | |TERMINAL (d) | 2/24 (8%) 2/22 (9%) 1/23 (4%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 692 567 681 659 |734 (T) --- --- 680 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.256N P=0.584 P=0.382N P=0.427N |P=0.549 P=0.557N P=0.500N P=0.722 | |POLY 3 | P=0.230N P=0.627 P=0.360N P=0.384N |P=0.557 P=0.522N P=0.512N P=0.732 | |POLY 1.5 | P=0.219N P=0.634 P=0.354N P=0.367N |P=0.557 P=0.513N P=0.507N P=0.742 | |POLY 6 | P=0.242N P=0.618 P=0.372N P=0.403N |P=0.559 P=0.534N P=0.515N P=0.722 | |LOGISTIC REGRESSION| P=0.233N P=0.622 P=0.373N P=0.398N |P=0.540 (e) (e) P=0.732 | |COCH-ARM / FISHERS | P=0.199N P=0.643N P=0.339N P=0.339N |P=0.562 P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/49 (8%) 3/49 (6%) 2/49 (4%) 2/49 (4%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 4/40.98 3/39.51 2/38.90 2/37.04 |1/43.24 0/38.70 0/40.77 1/38.13 | |POLY-3 PERCENT (g) | 9.8% 7.6% 5.1% 5.4% |2.3% 0.0% 0.0% 2.6% | |TERMINAL (d) | 2/24 (8%) 2/22 (9%) 1/23 (4%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 692 567 681 659 |734 (T) --- --- 680 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.308N P=0.561N P=0.382N P=0.427N |P=0.549 P=0.557N P=0.500N P=0.722 | |POLY 3 | P=0.280N P=0.520N P=0.360N P=0.384N |P=0.557 P=0.522N P=0.512N P=0.732 | |POLY 1.5 | P=0.270N P=0.511N P=0.354N P=0.367N |P=0.557 P=0.513N P=0.507N P=0.742 | |POLY 6 | P=0.291N P=0.533N P=0.372N P=0.403N |P=0.559 P=0.534N P=0.515N P=0.722 | |LOGISTIC REGRESSION| P=0.288N P=0.525N P=0.373N P=0.398N |P=0.540 (e) (e) P=0.732 | |COCH-ARM / FISHERS | P=0.249N P=0.500N P=0.339N P=0.339N |P=0.562 P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/49 (78%) 32/49 (65%) 36/48 (75%) 31/49 (63%) | | |POLY-3 RATE (b) | 38/44.45 32/43.09 36/43.13 31/40.84 | | |POLY-3 PERCENT (g) | 85.5% 74.3% 83.5% 75.9% | | |TERMINAL (d) | 24/24 (100%) 17/22 (77%) 20/23 (87%) 18/21 (86%) | | |FIRST INCIDENCE | 460 520 560 399 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.490N P=0.361N P=0.542 P=0.430N | | |POLY 3 | P=0.284N P=0.120N P=0.516N P=0.162N | | |POLY 1.5 | P=0.226N P=0.128N P=0.502N P=0.130N | | |POLY 6 | P=0.373N P=0.100N P=0.509N P=0.214N | | |LOGISTIC REGRESSION| P=0.405N P=0.183N P=0.590N P=0.281N | | |COCH-ARM / FISHERS | P=0.159N P=0.132N P=0.477N P=0.092N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/46 (20%) 6/47 (13%) 4/45 (9%) 4/47 (9%) |4/47 (9%) 4/46 (9%) 2/48 (4%) 1/48 (2%) | |POLY-3 RATE (b) | 9/39.52 6/39.17 4/37.68 4/36.20 |4/42.47 4/37.19 2/39.88 1/36.99 | |POLY-3 PERCENT (g) | 22.8% 15.3% 10.6% 11.1% |9.4% 10.8% 5.0% 2.7% | |TERMINAL (d) | 7/24 (29%) 4/22 (18%) 0/22 (0%) 2/20 (10%) |1/28 (4%) 3/21 (14%) 2/28 (7%) 1/24 (4%) | |FIRST INCIDENCE | 460 551 615 632 |602 677 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.148N P=0.342N P=0.163N P=0.197N |P=0.105N P=0.507 P=0.362N P=0.241N | |POLY 3 | P=0.106N P=0.289N P=0.129N P=0.146N |P=0.106N P=0.569 P=0.366N P=0.223N | |POLY 1.5 | P=0.097N P=0.282N P=0.126N P=0.128N |P=0.097N P=0.595 P=0.351N P=0.204N | |POLY 6 | P=0.117N P=0.299N P=0.131N P=0.168N |P=0.118N P=0.536 P=0.383N P=0.247N | |LOGISTIC REGRESSION| P=0.096N P=0.279N P=0.125N P=0.137N |P=0.106N P=0.593 P=0.340N P=0.190N | |COCH-ARM / FISHERS | P=0.085N P=0.272N P=0.124N P=0.107N |P=0.081N P=0.631 P=0.329N P=0.174N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/46 (2%) 2/47 (4%) 1/45 (2%) 1/47 (2%) |3/47 (6%) 2/46 (4%) 2/48 (4%) 0/48 (0%) | |POLY-3 RATE (b) | 1/38.43 2/38.51 1/36.67 1/35.61 |3/41.89 2/36.97 2/39.88 0/36.99 | |POLY-3 PERCENT (g) | 2.6% 5.2% 2.7% 2.8% |7.2% 5.4% 5.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 1/22 (5%) 1/22 (5%) 1/20 (5%) |2/28 (7%) 2/21 (10%) 2/28 (7%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) 643 733 (T) 733 (T) |690 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.558N P=0.480 P=0.743 P=0.722 |P=0.097N P=0.628N P=0.506N P=0.159N | |POLY 3 | P=0.524N P=0.501 P=0.751 P=0.744 |P=0.102N P=0.557N P=0.523N P=0.142N | |POLY 1.5 | P=0.512N P=0.504 P=0.753 P=0.753 |P=0.096N P=0.537N P=0.510N P=0.132N | |POLY 6 | P=0.540N P=0.496 P=0.746 P=0.731 |P=0.108N P=0.581N P=0.535N P=0.154N | |LOGISTIC REGRESSION| P=0.550N P=0.496 P=0.743 P=0.722 |P=0.107N P=0.599N P=0.532N P=0.154N | |COCH-ARM / FISHERS | P=0.497N P=0.508 P=0.747 P=0.747N |P=0.084N P=0.510N P=0.490N P=0.117N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/46 (22%) 8/47 (17%) 5/45 (11%) 5/47 (11%) |7/47 (15%) 6/46 (13%) 4/48 (8%) 1/48 (2%) | |POLY-3 RATE (b) | 10/39.52 8/39.50 5/37.68 5/36.20 |7/42.64 6/37.19 4/39.88 1/36.99 | |POLY-3 PERCENT (g) | 25.3% 20.3% 13.3% 13.8% |16.4% 16.1% 10.0% 2.7% | |TERMINAL (d) | 8/24 (33%) 5/22 (23%) 1/22 (5%) 3/20 (15%) |3/28 (11%) 5/21 (24%) 4/28 (14%) 1/24 (4%) | |FIRST INCIDENCE | 460 551 615 632 |602 677 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.151N P=0.463N P=0.182N P=0.223N |P=0.023N* P=0.540 P=0.284N P=0.062N | |POLY 3 | P=0.107N P=0.394N P=0.145N P=0.165N |P=0.024N* P=0.606N P=0.299N P=0.047N* | |POLY 1.5 | P=0.095N P=0.388N P=0.142N P=0.145N |P=0.020N* P=0.568N P=0.278N P=0.039N* | |POLY 6 | P=0.121N P=0.403N P=0.148N P=0.192N |P=0.029N* P=0.586 P=0.323N P=0.058N | |LOGISTIC REGRESSION| P=0.100N P=0.390N P=0.144N P=0.165N |P=0.025N* P=0.612N P=0.289N P=0.043N* | |COCH-ARM / FISHERS | P=0.081N P=0.377N P=0.139N P=0.120N |P=0.015N* P=0.517N P=0.249N P=0.027N* | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/49 (0%) 0/48 (0%) 2/49 (4%) |1/48 (2%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 1/39.72 0/38.97 0/38.70 2/36.65 |1/42.63 0/38.70 1/40.88 0/37.93 | |POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 5.5% |2.4% 0.0% 2.5% 0.0% | |TERMINAL (d) | 1/23 (4%) 0/22 (0%) 0/23 (0%) 2/21 (10%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) --- --- 733 (T) |734 (T) --- 707 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.206 P=0.509N P=0.500N P=0.468 |P=0.454N P=0.557N P=0.757 P=0.531N | |POLY 3 | P=0.217 P=0.504N P=0.505N P=0.472 |P=0.441N P=0.519N P=0.751 P=0.523N | |POLY 1.5 | P=0.220 P=0.500N P=0.503N P=0.485 |P=0.440N P=0.509N P=0.756 P=0.514N | |POLY 6 | P=0.214 P=0.508N P=0.509N P=0.457 |P=0.440N P=0.532N P=0.747 P=0.534N | |LOGISTIC REGRESSION| P=0.206 (e) (e) P=0.468 |P=0.463N (e) P=0.747 (e) | |COCH-ARM / FISHERS | P=0.226 P=0.495N P=0.500N P=0.508 |P=0.435N P=0.495N P=0.747N P=0.495N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |15/49 (31%) 7/49 (14%) 9/49 (18%) 7/49 (14%) | |POLY-3 RATE (b) | |15/45.34 7/39.36 9/41.98 7/38.18 | |POLY-3 PERCENT (g) | |33.1% 17.8% 21.4% 18.3% | |TERMINAL (d) | |9/28 (32%) 4/21 (19%) 7/28 (25%) 6/24 (25%) | |FIRST INCIDENCE | |519 635 480 667 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.118N P=0.157N P=0.148N P=0.114N | |POLY 3 | |P=0.118N P=0.085N P=0.162N P=0.099N | |POLY 1.5 | |P=0.105N P=0.064N P=0.144N P=0.074N | |POLY 6 | |P=0.135N P=0.120N P=0.185N P=0.136N | |LOGISTIC REGRESSION| |P=0.120N P=0.064N P=0.119N P=0.080N | |COCH-ARM / FISHERS | |P=0.084N P=0.044N* P=0.120N P=0.044N* | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/49 (2%) 1/49 (2%) |2/49 (4%) 1/49 (2%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/40.72 0/38.97 1/38.70 1/36.83 |2/43.72 1/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 2.7% |4.6% 2.6% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/22 (0%) 1/23 (4%) 0/21 (0%) |0/28 (0%) 1/21 (5%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- --- 733 (T) 685 |657 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.203 (e) P=0.492 P=0.466 |P=0.118N P=0.597N P=0.269N P=0.302N | |POLY 3 | P=0.197 (e) P=0.490 P=0.480 |P=0.102N P=0.542N P=0.253N P=0.270N | |POLY 1.5 | P=0.205 (e) P=0.493 P=0.487 |P=0.102N P=0.524N P=0.247N P=0.258N | |POLY 6 | P=0.189 (e) P=0.485 P=0.472 |P=0.102N P=0.566N P=0.259N P=0.284N | |LOGISTIC REGRESSION| P=0.196 (e) P=0.492 P=0.486 |P=0.107N P=0.515N P=0.215N P=0.222N | |COCH-ARM / FISHERS | P=0.219 (e) P=0.500 P=0.500 |P=0.102N P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/49 (0%) 2/49 (4%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/40.72 1/39.12 0/38.70 2/37.61 |1/43.46 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 0.0% 2.6% 0.0% 5.3% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 1/21 (5%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 695 --- 245 |677 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.142 P=0.465 (e) P=0.225 |P=0.351N P=0.535N P=0.523N P=0.542N | |POLY 3 | P=0.142 P=0.492 (e) P=0.219 |P=0.309N P=0.523N P=0.513N P=0.527N | |POLY 1.5 | P=0.147 P=0.495 (e) P=0.227 |P=0.317N P=0.513N P=0.508N P=0.518N | |POLY 6 | P=0.137 P=0.488 (e) P=0.211 |P=0.299N P=0.536N P=0.517N P=0.537N | |LOGISTIC REGRESSION| P=0.195 P=0.493 (e) P=0.395 |P=0.329N P=0.491N P=0.489N P=0.499N | |COCH-ARM / FISHERS | P=0.155 P=0.500 (e) P=0.247 |P=0.331N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/49 (0%) 2/49 (4%) |2/49 (4%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/40.72 1/39.12 0/38.70 2/37.61 |2/43.49 0/38.70 0/40.77 0/37.93 | |POLY-3 PERCENT (g) | 0.0% 2.6% 0.0% 5.3% |4.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 1/21 (5%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) | |FIRST INCIDENCE | --- 695 --- 245 |677 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.142 P=0.465 (e) P=0.225 |P=0.154N P=0.295N P=0.260N P=0.288N | |POLY 3 | P=0.142 P=0.492 (e) P=0.219 |P=0.124N P=0.264N P=0.252N P=0.269N | |POLY 1.5 | P=0.147 P=0.495 (e) P=0.227 |P=0.129N P=0.252N P=0.246N P=0.257N | |POLY 6 | P=0.137 P=0.488 (e) P=0.211 |P=0.118N P=0.280N P=0.257N P=0.282N | |LOGISTIC REGRESSION| P=0.195 P=0.493 (e) P=0.395 |P=0.147N P=0.256N P=0.244N P=0.260N | |COCH-ARM / FISHERS | P=0.155 P=0.500 (e) P=0.247 |P=0.139N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 26/49 (53%) 21/49 (43%) 24/49 (49%) 17/49 (35%) |16/49 (33%) 21/49 (43%) 15/49 (31%) 15/49 (31%) | |POLY-3 RATE (b) | 26/44.86 21/43.44 24/44.17 17/39.11 |16/46.21 21/43.57 15/42.72 15/41.19 | |POLY-3 PERCENT (g) | 58.0% 48.4% 54.3% 43.5% |34.6% 48.2% 35.1% 36.4% | |TERMINAL (d) | 12/24 (50%) 6/22 (27%) 7/23 (30%) 7/21 (33%) |3/28 (11%) 7/21 (33%) 8/28 (29%) 6/24 (25%) | |FIRST INCIDENCE | 469 502 560 527 |572 471 587 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250N P=0.362N P=0.539N P=0.213N |P=0.418N P=0.083 P=0.568 P=0.417 | |POLY 3 | P=0.168N P=0.240N P=0.447N P=0.127N |P=0.398N P=0.134 P=0.569 P=0.519 | |POLY 1.5 | P=0.124N P=0.229N P=0.455N P=0.090N |P=0.347N P=0.161 P=0.565N P=0.571 | |POLY 6 | P=0.224N P=0.249N P=0.429N P=0.181N |P=0.456N P=0.105 P=0.524 P=0.462 | |LOGISTIC REGRESSION| P=0.096N P=0.217N P=0.441N P=0.091N |P=0.255N P=0.290 P=0.496N P=0.486N | |COCH-ARM / FISHERS | P=0.070N P=0.209N P=0.420N P=0.051N |P=0.256N P=0.202 P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 1/49 (2%) 1/49 (2%) |0/49 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 2/40.72 0/38.97 1/39.41 1/36.65 |0/43.24 0/38.70 1/40.77 0/37.93 | |POLY-3 PERCENT (g) | 4.9% 0.0% 2.5% 2.7% |0.0% 0.0% 2.5% 0.0% | |TERMINAL (d) | 2/24 (8%) 0/22 (0%) 0/23 (0%) 1/21 (5%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) --- 489 733 (T) |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.570N P=0.257N P=0.507N P=0.547N |P=0.664 (e) P=0.500 (e) | |POLY 3 | P=0.553N P=0.247N P=0.511N P=0.537N |P=0.625 (e) P=0.488 (e) | |POLY 1.5 | P=0.550N P=0.243N P=0.509N P=0.523N |P=0.640 (e) P=0.493 (e) | |POLY 6 | P=0.555N P=0.252N P=0.517N P=0.552N |P=0.610 (e) P=0.485 (e) | |LOGISTIC REGRESSION| P=0.551N (e) P=0.486N P=0.547N |(e) (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.544N P=0.247N P=0.500N P=0.500N |P=0.669 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 1/49 (2%) 1/49 (2%) |0/49 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 2/40.72 0/38.97 1/39.41 1/36.65 |0/43.24 0/38.70 1/40.77 0/37.93 | |POLY-3 PERCENT (g) | 4.9% 0.0% 2.5% 2.7% |0.0% 0.0% 2.5% 0.0% | |TERMINAL (d) | 2/24 (8%) 0/22 (0%) 0/23 (0%) 1/21 (5%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 0/24 (0%) | |FIRST INCIDENCE | 733 (T) --- 489 733 (T) |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.570N P=0.257N P=0.507N P=0.547N |P=0.664 (e) P=0.500 (e) | |POLY 3 | P=0.553N P=0.247N P=0.511N P=0.537N |P=0.625 (e) P=0.488 (e) | |POLY 1.5 | P=0.550N P=0.243N P=0.509N P=0.523N |P=0.640 (e) P=0.493 (e) | |POLY 6 | P=0.555N P=0.252N P=0.517N P=0.552N |P=0.610 (e) P=0.485 (e) | |LOGISTIC REGRESSION| P=0.551N (e) P=0.486N P=0.547N |(e) (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.544N P=0.247N P=0.500N P=0.500N |P=0.669 (e) P=0.500 (e) | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 26 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 46/49 (94%) 47/49 (96%) 47/49 (96%) 47/49 (96%) |38/49 (78%) 41/49 (84%) 43/49 (88%) 35/49 (71%) | |POLY-3 RATE (b) | 46/46.83 47/47.69 47/47.21 47/47.41 |38/47.95 41/46.03 43/47.56 35/43.61 | |POLY-3 PERCENT (g) | 98.2% 98.6% 99.6% 99.1% |79.3% 89.1% 90.4% 80.3% | |TERMINAL (d) | 24/24 (100%) 22/22 (100%) 23/23 (100%) 21/21 (100%)|22/28 (79%) 19/21 (91%) 24/28 (86%) 19/24 (79%) | |FIRST INCIDENCE | 460 390 489 399 |509 509 440 482 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.173 P=0.291 P=0.327 P=0.160 |P=0.508N P=0.042 * P=0.195 P=0.356 | |POLY 3 | P=0.484 P=0.886 P=0.758 P=0.821 |P=0.507N P=0.141 P=0.100 P=0.558 | |POLY 1.5 | P=0.367 P=0.680 P=0.457 P=0.578 |P=0.396N P=0.193 P=0.109 P=0.544N | |POLY 6 | P=0.960 P=1.000N P=1.000 P=1.000 |P=0.499 P=0.107 P=0.107 P=0.461 | |LOGISTIC REGRESSION| P=0.092 P=0.362 P=0.517 P=0.125 |P=0.359N P=0.206 P=0.133 P=0.542N | |COCH-ARM / FISHERS | P=0.441 P=0.500 P=0.500 P=0.500 |P=0.195N P=0.305 P=0.143 P=0.322N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 34/49 (69%) 32/49 (65%) 34/49 (69%) 32/49 (65%) |26/49 (53%) 34/49 (69%) 26/49 (53%) 27/49 (55%) | |POLY-3 RATE (b) | 34/45.80 32/44.44 34/45.89 32/45.45 |26/46.43 34/46.28 26/45.98 27/45.85 | |POLY-3 PERCENT (g) | 74.2% 72.0% 74.1% 70.4% |56.0% 73.5% 56.6% 58.9% | |TERMINAL (d) | 16/24 (67%) 13/22 (59%) 13/23 (57%) 11/21 (52%) |12/28 (43%) 12/21 (57%) 12/28 (43%) 9/24 (38%) | |FIRST INCIDENCE | 469 502 433 245 |572 440 440 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.344 P=0.516 P=0.425 P=0.399 |P=0.513 P=0.022 * P=0.481 P=0.238 | |POLY 3 | P=0.407N P=0.499N P=0.590N P=0.428N |P=0.349N P=0.055 P=0.563 P=0.472 | |POLY 1.5 | P=0.412N P=0.467N P=0.573 P=0.416N |P=0.357N P=0.062 P=0.569 P=0.468 | |POLY 6 | P=0.415N P=0.528N P=0.556N P=0.453N |P=0.339N P=0.050 P=0.556 P=0.479 | |LOGISTIC REGRESSION| P=0.483N P=0.468N P=0.539 P=0.409N |P=0.257N P=0.092 P=0.543N P=0.575N | |COCH-ARM / FISHERS | P=0.434N P=0.415N P=0.587N P=0.415N |P=0.329N P=0.073 P=0.580N P=0.500 | |=================================================================================================================================| Date: 08/15/00 EXPERIMENT: 05110 TEST: 02 Page 27 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - NAPHTHALENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 48/49 (98%) 49/49 (100%) 48/49 (98%) 49/49 (100%)|44/49 (90%) 48/49 (98%) 47/49 (96%) 44/49 (90%) | |POLY-3 RATE (b) | 48/48.25 49/49.00 48/48.00 49/49.00 |44/48.56 48/49.00 47/48.22 44/48.00 | |POLY-3 PERCENT (g) | 99.5% 100.0% 100.0% 100.0% |90.6% 98.0% 97.5% 91.7% | |TERMINAL (d) | 24/24 (100%) 22/22 (100%) 23/23 (100%) 21/21 (100%)|24/28 (86%) 20/21 (95%) 27/28 (96%) 20/24 (83%) | |FIRST INCIDENCE | 460 390 433 245 |509 440 440 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.186 P=0.300 P=0.385 P=0.168 |P=0.371 P=0.028 * P=0.283 P=0.175 | |POLY 3 | P=0.943 P=0.999 P=0.999 P=0.999 |P=0.479N P=0.124 P=0.151 P=0.571 | |POLY 1.5 | P=0.595 P=0.842 P=0.848 P=0.842 |P=0.488N P=0.113 P=0.166 P=0.553 | |POLY 6 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.450N P=0.142 P=0.153 P=0.603 | |LOGISTIC REGRESSION| P=0.148 P=0.373 P=0.528 P=0.306 |P=0.411N P=0.141 P=0.185 P=0.575 | |COCH-ARM / FISHERS | P=0.438 P=0.500 P=0.753N P=0.500 |P=0.354N P=0.102 P=0.218 P=0.630N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (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. (g) Poly-3 adjusted lifetime tumor incidence. (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).