NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus CUPRIC SULFATE DATE: 10/15/04 EXPERIMENT: 05206 TEST: 05 TIME: 08:22:38 TEST TYPE: SUBCHRON 90-DAY PAGE: 1 CONT: NO1ES75169 ROUTE: DOSED FEED NTP C#: 62191B PATHOLOGIST: A. SINGER CAS: 7758-99-8 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 PPM INCLUDE 002 0 PPM INCLUDE 005 500 PPM INCLUDE 006 500 PPM INCLUDE 009 1000 PPM INCLUDE 010 1000 PPM INCLUDE 013 2000 PPM INCLUDE 014 2000 PPM INCLUDE 017 4000 PPM INCLUDE 018 4000 PPM INCLUDE 021 8000 PPM INCLUDE 022 8000 PPM NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus CUPRIC SULFATE DATE: 10/15/04 EXPERIMENT: 05206 TEST: 05 TIME: 08:22:38 TEST TYPE: SUBCHRON 90-DAY CONT: NO1ES75169 ROUTE: DOSED FEED NTP C#: 62191B PATHOLOGIST: A. SINGER CAS: 7758-99-8 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF CUPRIC SULFATE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Heart Adrenal Gland Cortex Kidney Cytoplasmic Alteration Nephropathy Kidney: Proximal Convoluted Renal Tubule Karyomegaly Liver Adrenal Gland Cortex Stomach Forestomach Hyperplasia =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Kidney Cytoplasmic Alteration Pigmentation Kidney: Proximal Convoluted Renal Tubule Karyomegaly Kidney: Renal Tubule Degeneration Liver Adrenal Gland Cortex Hepatodiaphragmatic Nodule Inflammation Focal Stomach Forestomach Hyperplasia =============================================================== Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Clitoral Gland | | Adrenal Gland Cortex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Clitoral Gland | | Adrenal Gland Cortex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/10 (90%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |POLY-3 RATE (b) | 9/10.00 0/0.00 0/0.00 0/0.00 0/0.00 10/10.00 | |POLY-3 PERCENT (g) | 90.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 9/10 (90%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.309 P=1.000 P=1.000 P=1.000 P=1.000N P=0.500 | |POLY 3 | (e) (e) P=0.943N (e) (e) P=0.500 | |POLY 1.5 | (e) (e) P=0.933N (e) (e) P=0.500 | |POLY 6 | (e) (e) P=0.943N (e) (e) P=0.500 | |LOGISTIC REGRESSION| P=0.304 (e) (e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.188 P=1.000 P=0.182N P=1.000 P=1.000 P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Heart | | Adrenal Gland Cortex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) | |POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/10.00 | |POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 50.0% | |TERMINAL (d) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012N* (e) (e) (e) (e) P=0.022N* | |POLY 3 | (e) (e) (e) (e) (e) P=0.008N** | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.008N** | |POLY 6 | (e) (e) (e) (e) (e) P=0.008N** | |LOGISTIC REGRESSION| P=0.012N* (e) (e) (e) (e) P=0.022N* | |COCH-ARM / FISHERS | P=0.010N* (e) (e) (e) (e) P=0.016N* | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Heart | | Adrenal Gland Cortex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.309 (e) (e) (e) (e) P=0.500 | |POLY 3 | (e) (e) (e) (e) (e) P=0.500 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.500 | |POLY 6 | (e) (e) (e) (e) (e) P=0.500 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.304 (e) (e) (e) (e) P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/9.00 0/10.00 3/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 30.0% 100.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) | |FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.111 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.095 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.095 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.095 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) P=0.111 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.105 P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 9/10 (90%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 1/9.00 9/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 11.1% 90.0% 100.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 9/10 (90%) 10/10 (100%) 10/10 (100%) | |FIRST INCIDENCE | --- --- 92 (T) 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.479 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.479 P<0.001 ** P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001 ** (e) P=0.480 P<0.001 ** P<0.001N** P<0.001N** | |POLY 6 | P<0.001 ** (e) P=0.479 P<0.001 ** P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| (e) (e) P=0.479 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/10 (100%) 9/9 (100%) 10/10 (100%) 8/10 (80%) 9/10 (90%) 6/10 (60%) | |POLY-3 RATE (b) | 10/10.00 9/9.00 10/10.00 8/10.00 9/10.00 6/10.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 80.0% 90.0% 60.0% | |TERMINAL (d) | 10/10 (100%) 9/9 (100%) 10/10 (100%) 8/10 (80%) 9/10 (90%) 6/10 (60%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002N** (e) (e) P=0.234N P=0.500N P=0.051N | |POLY 3 | P<0.001N** (e) (e) P=0.227N P=0.500N P=0.033N* | |POLY 1.5 | P<0.001N** (e) (e) P=0.227N P=0.500N P=0.033N* | |POLY 6 | P<0.001N** (e) (e) P=0.227N P=0.500N P=0.033N* | |LOGISTIC REGRESSION| P=0.002N** (e) (e) P=0.234N P=0.500N P=0.051N | |COCH-ARM / FISHERS | P=0.002N** (e) (e) P=0.237N P=0.500N P=0.043N* | |ORDER RESTRICTED | P=0.002N** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 1/9.00 1/10.00 0/10.00 2/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 11.1% 10.0% 0.0% 20.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 1/10 (10%) 0/10 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- 92 (T) 92 (T) --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.111 (e) P=0.479 P=0.500 (e) P=0.234 | |POLY 3 | P=0.106 (e) P=0.479 P=0.500 (e) P=0.227 | |POLY 1.5 | P=0.106 (e) P=0.480 P=0.500 (e) P=0.227 | |POLY 6 | P=0.106 (e) P=0.479 P=0.500 (e) P=0.227 | |LOGISTIC REGRESSION| (e) (e) P=0.479 P=0.500 (e) P=0.234 | |COCH-ARM / FISHERS | P=0.104 (e) P=0.500 P=0.500 (e) P=0.237 | |ORDER RESTRICTED | P=0.055 (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 0/9.00 0/10.00 0/10.00 0/10.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/9.00 0/10.00 0/10.00 2/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 20.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012 * (e) (e) (e) (e) P=0.234 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.227 | |POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.227 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.227 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.234 | |COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.237 | |ORDER RESTRICTED | P=0.007 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney: Proximal Convoluted Renal Tubule | | Karyomegaly | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/9.00 0/10.00 0/10.00 0/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) | |FIRST INCIDENCE | --- --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 3 | P<0.001N** (e) (e) (e) (e) P<0.001N** | |POLY 1.5 | P<0.001N** (e) (e) (e) (e) P<0.001N** | |POLY 6 | P<0.001N** (e) (e) (e) (e) P<0.001N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney: Proximal Convoluted Renal Tubule | | Karyomegaly | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/9.00 0/10.00 0/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) | |FIRST INCIDENCE | --- --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 0/9.00 0/10.00 0/10.00 0/10.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/9.00 0/10.00 0/10.00 3/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 30.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.111 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.095 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.095 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.095 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.111 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.105 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Liver | | Adrenal Gland Cortex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 1/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.0% 100.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) | |FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** | |POLY 3 | (e) (e) (e) P=0.500 P<0.001N** P<0.001 ** | |POLY 1.5 | (e) (e) (e) P=0.500 P<0.001N** P<0.001 ** | |POLY 6 | (e) (e) (e) P=0.500 P<0.001N** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) P=0.500 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Liver | | Adrenal Gland Cortex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/2 (0%) 0/10 (0%) 6/10 (60%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/1.00 0/2.00 0/10.00 6/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 60.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/2 (0%) 0/10 (0%) 6/10 (60%) 10/10 (100%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.009 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.009 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.005 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 0/0 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 1/10.00 0/0.00 1/10.00 1/10.00 0/10.00 0/10.00 | |POLY-3 PERCENT (g) | 10.0% 0.0% 10.0% 10.0% 0.0% 0.0% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) --- 92 (T) 92 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.202N P=1.000N P=0.766 P=0.766 P=0.500N P=0.500N | |POLY 3 | (e) (e) P=0.760 P=0.760 P=0.500N P=0.500N | |POLY 1.5 | (e) (e) P=0.760 P=0.760 P=0.500N P=0.500N | |POLY 6 | (e) (e) P=0.760 P=0.760 P=0.500N P=0.500N | |LOGISTIC REGRESSION| P=0.202N (e) P=0.766 P=0.766 (e) (e) | |COCH-ARM / FISHERS | P=0.200N P=1.000 P=0.763N P=0.763N P=0.500N P=0.500N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 1/1 (100%) 2/2 (100%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 2/10.00 1/1.00 2/2.00 2/10.00 0/10.00 0/10.00 | |POLY-3 PERCENT (g) | 20.0% 100.0% 100.0% 20.0% 0.0% 0.0% | |TERMINAL (d) | 2/10 (20%) 1/1 (100%) 2/2 (100%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.020N* P=0.305 P=0.095 P=0.707 P=0.234N P=0.234N | |POLY 3 | P=0.005N** P=0.286 P=0.053 P=0.702 P=0.227N P=0.227N | |POLY 1.5 | P=0.005N** P=0.286 P=0.053 P=0.702 P=0.227N P=0.227N | |POLY 6 | P=0.005N** P=0.286 P=0.053 P=0.702 P=0.227N P=0.227N | |LOGISTIC REGRESSION| P=0.020N* P=0.305 P=0.095 P=0.707 (e) (e) | |COCH-ARM / FISHERS | P=0.019N* P=0.273 P=0.091 P=0.709N P=0.237N P=0.237N | |ORDER RESTRICTED | P=0.003N** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Liver | | Inflammation Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 0/10.00 0/10.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Liver | | Inflammation Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 0/1 (0%) 0/2 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 2/10.00 0/1.00 0/2.00 0/10.00 0/10.00 0/10.00 | |POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/10 (20%) 0/1 (0%) 0/2 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.129N P=0.795N P=0.630N P=0.234N P=0.234N P=0.234N | |POLY 3 | P=0.124N P=0.786N P=0.627N P=0.227N P=0.227N P=0.227N | |POLY 1.5 | P=0.124N P=0.786N P=0.627N P=0.227N P=0.227N P=0.227N | |POLY 6 | P=0.124N P=0.786N P=0.627N P=0.227N P=0.227N P=0.227N | |LOGISTIC REGRESSION| P=0.129N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.127N P=0.818N P=0.682N P=0.237N P=0.237N P=0.237N | |ORDER RESTRICTED | P=0.007N** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 | |POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 10.0% | |TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.380N P=1.000N P=1.000N P=1.000 P=1.000 P=0.500N | |POLY 3 | (e) (e) (e) (e) (e) P=0.500N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.500N | |POLY 6 | (e) (e) (e) (e) (e) P=0.500N | |LOGISTIC REGRESSION| P=0.380N (e) (e) (e) (e) P=0.500N | |COCH-ARM / FISHERS | P=0.377N P=1.000 P=1.000 P=1.000 P=1.000 P=0.500N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |POLY-3 RATE (b) | 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 | |POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 10.0% | |TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.642 P=1.000 P=1.000 P=1.000 P=1.000 P=0.766 | |POLY 3 | (e) (e) P=0.943N (e) (e) P=0.760 | |POLY 1.5 | (e) (e) P=0.943N (e) (e) P=0.760 | |POLY 6 | (e) (e) P=0.943N (e) (e) P=0.760 | |LOGISTIC REGRESSION| P=0.645N (e) (e) (e) (e) P=0.766 | |COCH-ARM / FISHERS | P=0.626 P=1.000 P=0.909N P=1.000 P=1.000 P=0.763N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Preputial Gland | | Adrenal Gland Cortex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/10 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) | |POLY-3 RATE (b) | 7/10.00 0/0.00 0/0.00 0/0.00 0/0.00 8/10.00 | |POLY-3 PERCENT (g) | 70.0% 0.0% 0.0% 0.0% 0.0% 80.0% | |TERMINAL (d) | 7/10 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.401 P=1.000N P=1.000N P=1.000 P=1.000 P=0.500 | |POLY 3 | (e) (e) (e) (e) (e) P=0.500 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.500 | |POLY 6 | (e) (e) (e) (e) (e) P=0.500 | |LOGISTIC REGRESSION| P=0.401 (e) (e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.398 P=1.000 P=1.000 P=1.000 P=1.000 P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Preputial Gland | | Adrenal Gland Cortex | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| Date: 10/15/04 EXPERIMENT: 05206 TEST: 05 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - CUPRIC SULFATE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Stomach Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/1.00 0/10.00 10/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) | |FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001N** (e) (e) P<0.001 ** P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** (e) (e) P<0.001 ** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** (e) (e) P<0.001 ** P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 PPM 500 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM | | | | |=================================================================================================================================| | | |Stomach Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 7/10 (70%) 10/10 (100%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/0.00 0/9.00 7/10.00 10/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 70.0% 100.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/9 (0%) 7/10 (70%) 10/10 (100%) 10/10 (100%) | |FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.003 ** P<0.001 ** P<0.001 ** | |POLY 3 | (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) P=0.003 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.002 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| (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).