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Individual blood lead concentrations (|ig/mL) in microswine DuPont HLR 581-94 Collection Time(hrs) 0 0.5 1 2 4 8 12 24 48 72 96 120 144 192 240 GROUP: A TEST SUBSTANCE: AEC3-3 Animal Animal Animal Animal 1043 1071 987 1012 Mean 0.005 0.099 0.227 0,301 0,553a 0.206b 0.210 0.605 0.348 0-143 0.106 0.058 0.141 0.076 0.055 0.010 0.158 0.120 0.823 0.382 0.053 0.134 0.302 0.533 0.057 0.102 0.086 0.073a 0.057 0,050 0.007 0.231 0.386 0.431 0.603 0.312a 0.322c 0.375a 0.286 0.156a 0.196 0.080a 0.092 0.087 0.058 0.067 0.450 0.511 0.488a 0.407 0.242a 0.199 0,395 0.167 0.214 0.093 0.045 0.182 0.051 0.054 0.02 0.23 0.31 0.51 0.49 0.20 0.22 0.42 0.33 0.14 0.12 0.07 0.12 0.07 0.05 S.D. 0.03 0.15 0.17 0.22 0.11 0.11 0.08 0.13 0.15 0.07 0.05 0.02 0.05 0-02 0.00 GROUP: B TEST SUBSTANCE: AEC 9-3 Collection Time (hrs) Animal Animal Animal Animal 1033 986 1003 1027 0 0.5 1 2........... 4 8 12 24 48 72 96 120 144 192 240 0,011 0,083 0.145 0.346 0.286 0.344 0.173 0.094b 0.088 0.085 0.054 0.070 0.108 0.078 0.047 0.005 0.007b 0.017b 0.697c 0.100 0.160 0.237 0.240 0.148 0.091 0.099 0.067 0.093 0.020 0.036 0.005 0.051 0.122 0.400 0.454 0.289 0.278 0.193 0.159 0.095 0.074a 0.073 0.111 0.017 0.045 0.008 0.167 0.227 0.296a 0.386 0.470 0.357 0.283 0.121 0.190 0.127 0.115 0,179 0,053 0.111 Mean 0.01 0.08 0.13 0.43 0.31 0.32 0.26 0-20 0.13 0.12 0.09 0.08 0.12 0.04 0.06 S.t>, 0.00 0.07 0-09 0.18 0.15 0.13 0-08 0.08 0.03 0.05 0.03 0,02 0.04 0.03 0.04 a Analysis repeated; results from repeated analysis replace results from original analysis. b Analysis repeated; results from repeated analysis not used. c Analysis repeated twice; results from first repeated analysis replace results from original analysis. -69- DuPont HLR 581-94 Individual blood lead concentrations (iig/mL) in micrsowine (continued). Collection Time (hrs) 0 0.5 1 2 4 8 12 24 48 72 96 120 144 192 240 GROUP: C TEST SUBSTANCE: Lead Acetate Animal Animal Animal Animal Animal 981 1064 1041 996 992 Mean 0.008 2.460 1.800 2.370 0.538 0.784 0.640 0.497 0.214 0.329 0.372 0.2660.224 0.181 0.131 0.005 12.400b 11.430b 3.660 1.990b 0.821 1.060 0.946 0.680 0.512 0.479 0.388 0.259 0.272 0.298 0.005 2.700 4.330 2.670 1.270b 1.760b 1.050 0.795 0.518 0,359 0.297 . 0,283 0.189 0.231 0.159 0.011 1.030 0,218b 0.430b 0.326 0.569 0.305 0-349 0.119 0.134 0.160 0.124 0.121 0,076 0.092 0.005b 0.138b 0.088a 0,175b 0.205b 0,809a 0.180b 0.133b 0.107a 0,129a 0.128a 0.066b 0.091a 0.043b 0.021b 0.01 3.75 3.57 1.86 0.87 0.95 0.65 0.54 0.33 0.29 0.29 0.23 0,18 0.16 0.14 S.D, 0.00 4.95 4.71 1.50 0.75 0.47 0.41 0.33 0.26 0.16 0.15 0.13 0.07 0.10 0.10 GROUP: D TEST SUBSTANCE: AEC10-1 Collection Time (hrs) Animal Animal Animal Animal Animal 965 1052 972 1024 973 Mean 0 0.5 ... 1........... 2 4 8 12 24 48 72 96 120 144 192 240 0.005 0.041 0.075 0.114 0.282 0.161 0.182 0.160 0.144 0.088 0.094 0.055 0.022 0.047 0.051 0.005 0,005 0.005 0.005 0.095 0.328 0,300 0.391 0.193 0.170 0.136 0.093 0.076 0.054 0.055 0.042 0.008 0.074 0.095 0.283 0.260 0.160 0.241 0.199 0.148 0.126 0.076 0.055 0.041 0.037 0.005 0.111 0.173 0.338 0.804 0.403 0.338 0.264 0.193 0.209 0.169 0,136 0.111 0.078 0.059 0.005 0.128 0.251 0.205 0.624 0.191 0.196 0.263 0.210 0.173 0.122 0.063 0.062 0.075 0.050 0.01 0.06 0.12 0.15 0.42 0.27 0,24 0,26 0.19 0.16 0.13 0.08 0,07 0.06 0.05 S.D. 0.02 0.06 0-10 0.13 0.29 0.10 0.08 0.08 0.03 0,05 0.03 0.03 0.03 0.02 0.01 a Analysis repeated; results from repeated analysis replace results from original analysis. b Analysis repeated; results from repeated analysis not used. c Analysis repeated twice; results from first repeated analysis replace results from original analysis. -70- DUP040005116 DuPont HDR 581-94 Individual blood lead concentrations (tig/mL) in micrsowine (continued). Collection Time (hrs) 0 0.5 1 2 4 8 12 24 48 72 96 120 144 192 240 GROUP: E TEST SUBSTANCE: PLW Animal Animal Animal Animal Animal Animal 00 175 1255 1212 144 1251 0.005 0.008 0.005 0.005 0.075 0-131 0.088 0.069 0.022 0.055 0.028 0.035 0.014 0.005 0.032 0.007 0.005 0.005 0.005 0.013 0.097 0.077 0.118 0.040 0.044 0.039 0.037 0.026 0.032 0.018 0.005 0.005 0.005 0.005 0.012 0.043 0.047 0.048 0.021 0.028 0.025 0.013 0.010 0,011 0,017 0.005 0.005 0.005 0.005 0.019 0.069 0.068 0.081 0,032 0.061 0.037 0.028 0.021 0.032 0.033 0.005 0,005 0,011 0.005 0,040 0.056 0.062 0.067 0.018 0,031 0.031 0.019 0.015 0.008 0.020 o.on 0.005 0.005 0.005 0.119 0.063 0.037 0,041 0.013 0.024 0.014 0.016 0.011 0.026 0.017 Mean 0.01 0.01 0.01 0.01 0.05 0.08 0.06 0.07 0.02 0,04 0.03 0.02 0.02 0.02 0.02 S.D, 0.00 0.00 0.00 0.00 0.04 0.03 0.02 0.03 0.01 0.02 0.01 0.01 0.01 0.01 0.01 GROUP: G TEST SUBSTANCE: EC1 Collection Time (hrs) Animal Animal Animal Animal Animal Animal 1191 1241 1242 1246 145 ' 196 0 0.5 1 2 4 8 12 24 48 72 96 120 144 192 240 .... 0.045 0.042 0.044 0.046 0.051 0.058 0.102 O.083 0.112 0.061 0,061 0.042 0.042 0.033 0.054 0.048 0.046 0.021 0.054 0.053 0.097 0.120 0.191 0.106 0,067 0.061 0.079 0.056 0.057 0.049 0.038 0.052 0.048 0.055 0.039 0.049 0.107 0.187 0.124 0.082 0.063 0.074 0.065 0.063 0.076 0.034 0.052 0.050 0.048 0.057 0.060 0.087 0.176 0.098 0.102 0.094 0.097 0.082 0.065 0.064 0.040 0.067 0.055 0.031 0.070 0.046 0.077 0.128 0.067 0.055 0.059 0.077 0.026 0,061 0,084 0.033 0.026 0.060 0.050 0.062 0.052 0.079 0.155 0.082 0.061 0.081 0.069 0.055 0.054 0.066 Mean 0.04 0.05 0.05 0.05 0.06 0.06 0.10 0.15 0.10 0.07 0.07 0-07 0.05 0.06 0.07 S.D. o.oi 0.01 0.01 0.01 0.01 0.02 0.02 0.04 0.02 0.02 0.01 0.02 0.02 0.01 0.01 -71- DUP040005117 DuPont HLR 581-94 Individual blood lead concentrations (ug/mL) ip micrsowine (continued). Collection Time (hrs) 0 0.5 "... 1 2 4 8 12 24 48 72 96 120 144 192 240 GROUP: H TEST SUBSTANCE: FM Animal Animal Animal Animal Animal 452 404 453 442 423 0.0Q5 0.009 0.027 0.060 0.247 0.130 0.175 0.152 0.080 0.055 0.061 0.045 0.048 0.035 0.021a 0.011 0.010 0.009 0.005 0.029 0.070 0.086 0.068 0,035 0.015 0.015 0.014 0.011 0.008 0.015a 0.005 0.010 0.020 0.034 0.130 0.113 0.089 0.072 0.028 0.021 0.028 0.017 0.024 0.021 0.038a 0.005 0.008 0.005 0.005 0.043 0.045 0.091 0.064 0.030 0.013 0.013 0.021 0.021 0.015 0.015a 0.005 0.011 0.033 0.059 0.174 0.156 0.103 0.068 0.045 0.018 0,022 0.017 0.026 0.007 0.027a Mean 0.01 0.01 0.02 0.03 0.12 0.10 0.11 0.08 0.04 0.02 0.03 0.02 0.03 0.02 0.02 S.D. 0.00 0.00 0.01 0,03 0.09 0.05 0.04 0.04 0.02 0.02 0.02 0.01 0.01 0.01 0.01 Collection Time (hrs) 0 0.5 1 24 8 12 24 48 72 96 120 144 192 240 GROUP: I TEST SUBSTANCE: Lead Acetate Animal Animal Animal Animal Animal 405 456 422 381 454 Mean 0.013 0.441 0.529 0.509 0.167 0.209 0.224 0.164 0.113 0.096 0.074 0.064 0.056 0.040 0.070 0.014 0.037 0.075 0.177 0.046 0.052 0.035 0.060 0.037 0.042 0.041 0.027 0.016 0.026 0.024 0.010 0.162 0.133 0.258 0.127 0.152 0.112 0.093 0.074 0.059 0.045 0.058 0.041 0.044 0.053 0.013 0.529 0.469 0.336 0.302 0.232 0.148 0.098 0,083 0.108 0.070 0.043 0.064 0.041 0.035 0.006 0.223 0.166 0.344 0.225 0.190 0.139 0.142 0.108 0.112 0.072 0.052 0.034 0.046 0.050 0.01 0.28 0.27 0.32 0.17 0.17 0.13 0.11 0.08 0.08 0.06 0.05 0.04 0.04 0.05 S.D. 0.00 0.20 0.21 0.12 0.10 0.07 0.07 0.04 0.03 0.03 0.02 0.01 0.02 0.01 0.02 Analysis repeated; results from repeated analysis replace results from original analysis. -72- DUP040005118 DuPontHLR 581-94 Individual blood lead concentrations (ug/mL) in micrsowine (continued). GROUP: J TEST SUBSTANCE: PLW1 Collection Time (hrs) Animal Animal Animal Animal Animal 394 455 443 451 401 0 0.5 .... 1 ....... 2 4 8 12 24 48 72 96 120 144 192 240 0.005 0.019 0.029 0.132 0.079 0.214 0.154 0.251 0.340 0.159 0.043 0.036 0.039 0.017 0.007 0.005 0.780 1.758 1.439 0.493 0.366 0.412 0.614 0.421 0.200 0.071 0.054 0.069 0.065 0.067 0.005 0.195 0.123 0.308 0.296 0.282 0.219 0.328 0.641 0.083 0.056 0.041 0.054 0.047 0.040 0.005 0.088 0.064 0.597 0.288 0.685 0.357 0.459 0.418 0.135 0.043 0.034 0.025 0.030 0.023 0.005 0.443 1.167 0.979 0.547 0.375 0.328 0.388 0.861 0.096 0.070 0.038 0.071 0.048 0.061 Mean 0.01 0.31 0.63 0.69 0.34 0.38 0.29 0.41 0.54 0.13 0.06 0.04 0.05 0.04 0.04 SD. 0.00 0.31 0.79 0.53 0.19 0.18 0.11 0.14 0.21 0.05 0.01 0.01 0.02 0.02 0.03 -73- DUP040005119 Blood Sample Label Animal Number Blood Sample Label Animal Number Blood Sample Label Animal Number Blood Sample Label Animal Number Blood Sample Label Animal Number Blood Sample Label Animal Number APPENDIX D- Individual body weights (g) of microswine. DuPont HLR 581-94 The table below correlates the animal numbering system used in the study to the numbering system used to label the blood collection data. Group Designation Test Soil A AEC 3-3 B AEC 9-3 C Pb Acetate D AEC 10-1 E PLW G EC1 H FM 1 Pb Acetate J PLW1 101 1043 102 1071 103 987 104 984 105 1012 201 1033 202 986 203 1003 204 1094 205 1027 301 981 302 1064 303 1041 304 996 305 992 401 965 402 1052 403 972 404 1024 405 973 101 185 102 175 103 1255 104 1212 105 144 106 1251 301 1191 302 1241 303 1242 304 1246 305 145 306 196 101 452 102 404 103 453 104 442 105 423 201 405 202 456 203 422 204 381 205 454 301 394 302 455 303 443 304 451 305 401 -74- DUP040005120 Individual body weights (g) of microswine. DuPont HLR 581-94 Days on Test: 1 GROUP; A 3 TEST SUBSTANCE: AEC 3-3 7 11 Animal Number 1043 1071 987 984 1012 4801.0 6074.0 7264.0 8031.0 5206.0 5047.0 5688.0 6212.0 6576.0 7367.0 7947.0 Sacrificed in extremis (DAY 2) 5358.0 . 5873.0 6409.0 7535.0 9129.0 6551.0 GROUP: B TEST SUBSTANCE: AEC 9-3 Days on Test: 1 4 6 10 11 Animal Number 1033 986 1003 1094 1027 6285.0 7132.0 9532.0 5781.0 6051.0 6700.0 7020.0 7645.0 8034.0 9868.0 10460.0 Accidentally Killed (DAY 1) 6333.0 6824.0 7370.0 8648.0 10870.0 7274.0 7557.0 9005.0 11220.0 7500.0 Days on Test: 1 Animal Number 981 1064 1041 996 992 9768.0 5191.0 6580.0 7879.0 8250.0 GROUP: C 9 11422.0 6717.0 8195.0 9471.0 9852.0 TEST SUBSTANCE: Lead Acetate 11 11662.0 7050.0 8491.0 9768.0 10143.0 -75- DUP040005121 Individual body weights (g) of microswine (continued). DuPont HLR 581-94 Days on Test: 1 Animal Number 965 1052 972 1024 973 7954.0 3628,0 9833.0 6849.0 7593.0 GROUP: D 6 8799.0 4816,0 10394.0 7798.0 8257.0 TEST SUBSTANCE: AEC10-1 8 11 8933.0 5292.0 10798.0 8025.0 8443.0 9727.0 5863.0 11217.0 8709.0 8963.0 Days on Test: 1 Animal Number 185 175 1255 1212 144 1251 6169.0 7256.0 6055.0 6175,0 7904,0 5882.0 GROUP: E 4 TEST SUBSTANCE: PLW 8 11 6704,0 7611.0 6336.0 6564.0 8333.0 6159.0 7465.0 8289.0 6953.0 7124.0 8934.0 6689.0 7734.0 8792.0 7210.0 7486.0 9371.0 6914.0 ............-.. --- Days on Test: 1 Animal Number 1191 1241 1242 1246 145 196 7987.0 8341.0 6391.0 7400.0 9279.0 6818.0 GROUP: G 4 TEST SUBSTANCE: EC1 7 11 8351.0 8608.0 6694.0 7831.0 9543.0 7285.0 8704.0 . 9199.0 7126.0 8322.0 9903.0 7797.0 9290.0 9483.0 7597.0 9023.0 10395.0 8408.0 -76- DUP040005122 Individual body weights (g) of microswine (continued). Days on Test: 1 Animal Number 452 404 453 442 423 7089.0 5958.0 5823.0 6566.0 5189.0 GROUP: H 3 TEST SUBSTANCE: FM 7 11 7438.0 6405,0 6198.0 6838.0 5525.0 7933.0 6929.0 6660.0 7189.0 6102.0 8610.0 7313.0 7384.0 7847.0 6711.0 DuPont HLR 581-94 Days on Test: 1 Animal Number 405 456 422 381 454 6867.0 6558.0 6288.0 6189.0 7100.0 GROUP: I 4 7257.0 6993.0 6653.0 6490.0 7379.0 TEST SUBSTANCE: Lead Acetate 8 11 8086.0 7612.0 7428.0 7232.0 7988,0 8483.0 8029.0 7998.0 7830.0 8252.0 Days on Test: 1 Animal Number 394 455 443 451 401 4464.0 6869.0 7586.0 6867.0 6420.0 GROUP: J 4 TEST SUBSTANCE: PLW1 7 11 5107.0 7397.0 7966.0 7182.0 6886.0 5629.0 7841.0 8244.0 7529.0 7290.0 6330.0 8502.0 8720.0 8162.0 7870.0 -77- DUP040005123 APPENDIX E. Individual clinical observations in microswine. DuPont HLR 581-94 The table below correlates the animal numbering system used in the study to the nnmhftrtng system used to label the blood collection data. Blood Sample Label Animal Number Blood Sample Label Animal Number Animal Number Blood Sample Label Animal Number Blood Sample Label Blood Sample Label Group Designation Test Soil A AEC 3-3 B AEC9-3 C Pb Acetate D AEC 10-1 E PLW G EC1 H FM 1 Pb Acetate J PLW1 d) 3 Xm <D a B& CO too3 .....X E. z3 : to E x> z-.3 <8 I CQ f 101 1043 102 1071 103 987 104 984 105 1012 : 201 1033 202 986 203 1003 204 1094 205 1027 301 981 302 1064 : 303 1041 304 996 305 992 401 965 402 1052 403 972 404 1024 405 973 101 185 102 175 103 1255 104 1212 105 144 106 1251 301 1191 302 1241 303 1242 304 1246 805 145 306 196 101 452 102 404 103 453 104 442 105 423 201 405 202 456 203 422 204 381 205 454 301 394 302 455 i 303 443 304 451 305 401 -78- DUP040005124 Individual clinical observations in microswine. DuPontHLR 581-94 Animal Number 1043 1071 987 984 1012 GROUP: A TEST SUBSTANCE: AEC3-3 Observation First Day Observed No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed in extremis Test Day 2 No Abnormalities Detected Sacrificed by Design Test Day 11 Last Day Observed Animal Number 1033 986 1003 1094 1027 GROUP: B TEST SUBSTANCE: AEC9-3 Observation No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Accidentally Killed Test Day 1 No Abnormalities Detected Sacrificed by Design Test Day 11 First Day Observed Last Day Observed -79- DUP040005125 Individual clinical observations in microswine (continued). DuPont HLR 581-94 Animal Number 981 1064 1041 996 992 GROUP: C TEST SUBSTANCE: Lead Acetate Observation First Day Observed No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 Last Day Observed Animal Number 965 1052 972 1024 973 GROUP: D TEST SUBSTANCE: AEC10-1 Observation First Day Observed No Abnormalities Detected Sacrificed by Design Test Day 11 Diarrhea Sacrificed by Design Test Day 11 8 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 Last Day Observed 8 -80- DUP040005126 Individual clinical observations in microswine (continued). DuPont HLR 581-94 Animal Number 185 17:5 1255 1212 144 1251 GROUP: E TEST SUBSTANCE: PLW Observation First Day Observed No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 Last Day Observed Animal Number 1191 1241 1242 1246 145 196 GROUP: G TEST SUBSTANCE: EC1 Observation First Day Observed No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day H No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 Last Day Observed -81- DUP040005127 Individual clinical observations in microswine (continued). DuPont HLR 581-94 Animal Number 452 404 453 442 423 GROUP: H TEST SUBSTANCE: FM Observation No Abnormalities Detected Sacrificed by Design Test Day 11 Bent Right Front Paw(s) Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 First Day Observed .^ Last Day Observed 11 NR Animal Number 405 456 422 381 454 GROUP; I TEST SUBSTANCE: Lead Acetate Observation No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 First Day Observed Last Day Observed ... ----- ------------ -82- DUP040005128 Individual clinical observations in microswine (continued). DuPont HLR 581-94 Animal Number 394 455 443 451 401 GROUP: J TEST SUBSTANCE: PLW1 Observation No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 No Abnormalities Detected Sacrificed by Design Test Day 11 First Day Observed Last Day Observed -83- DUP040005129 APPENDIX F Sample calculations DuPont HI.R SHI-94 -84- DUP040005130 1. Sample calculation for the amount of lead in the dose. DuPont HLR 581-94 Formula: Concentration of Lead (ppm) x Gavage Sample (g) x Dilution Factor = Lead in Sample (mg) Example: Soil PLW Mean lead analyzed = 244.5 ppm Gavage sample = 21.17 g soil + 30 g water = 51.17 g Dilution factor = 0.75 Concentration of lead derived from analysis during the study. Soil weight (21.17 g) was calculated in order to give each animal 17 mg of lead. This soil lead conentration is 803 ppm (information obtained from the study sponsor). The dose was prepared for 10 animals. 211.7 g soil was weighed and mixed with 300 mL water; 30 mL of the mixture was given to each animal. In some cases, the soil did not mix well, so the amount of water was increased to 400 or 500 mL. This additional water is the reason for the dilution factor used in the calculations. 244.5 ppm x 51.17 g x 0.75 = lead in sample (mg) 0.2445 mg/g x 51.17 g x 0.75 = lead in sample (mg) 9.383 mg = lead in sample - 85- DUP040005131 2. Sample calculation for area under the curve (AUC). Formulas: Slope = -p/2.303 Area = Value of Last Time Point / P Total AUC = Area + Area = Example: Plasma Datafrom Animal #987, Group A (AEC 3-3) DuPont HLR 581-94 Area = 39.54825 B (slope + std.dev.) = -0.00264 0.00121 Concentration at Last Time Point s= 0.058 jig/mL Slope = -P / 2.303 -0.00264 = -p/2.303 -0.00264 x 2.303 = -p 0.0060799 = P Area ~ = 0.058 / P Area** = 0.058 / 0.0060799 Area<*= = 9.5396306 Total AUC = Area + Area = Total AUC = 39.54825 + 9.5396306 Total AUC = 49.087881 pg(hr)/mL 86 DUP040005132 APPENDIX G. Lead analyses reports. DuPont HLR 581-94 The table below correlates the animal numbering system used in the study to the numbering system used to label the blood collection data. Blood Sample Label Animal Number Blood Sample Label | Animal Number Blood Sample Label Animal Number Blood Sample Label Animal Number Blood Sample Label Animal Number Group Designation Test Soil A AEC 3-3 B AEC 9-3 C Pb Acetate D AEC 10-1 E PLW G EC1 H FM 1 Pb Acetate J PLW1 101 1043 201 1033 301 981 401 965 101 185 301 1191 101 452 201 405 301 394 102 1071 202 986 302 1064 402 1052 102 175 302 1241 102 404 202 456 302 455 1_ <1) Q. E E 3 <n z 73 O as E O 5 m 103 987 203 1003 303 1041 403 972 103 1255 303 1242 103 453 203 422 303 443 104 984 204 1094 304 996 404 1024 104 1212 304 1246 104 442 204 381 304 451 105 1012 205 1027 305 992 405 973 105 144 305 145 105 423 205 454 305 401 106 1251 306 196 -87- DUP04000S133 Lead Analysis Report #1: Soils AEC 3-3, AEC 9-3, and AEC10-1 DuPont HLR 581-94 Analysis ofPb in Blood, Soil, and Associated Materials in Support ofHaskell Lab Medical Research ProjectNo. MR9727-001 Author Keith A- McCleary Study Completed: 1/26/94 Performed By: DuPont Specialty Chemicals Trace Metals Analysis Group Quality Control Laboratory Chambers Works .....Deepwater, NJ 08023------ -88- DUP040005134 Lead Analysis Report #1: Soils AEC 3-3, AEC 9-3, and AEC10-1 DuPont HLR 581-94 Summary The purpose ofthis study was to determine the amount oflead that was contained in samples associated with MR9727-001. There Were essentially three type ofsamples: blood (microswine), aqueous (drinking water, dosing solutions), and solid (soil, bedding, etc.).. Blood samples were prepared by dilution with a modifier solution (to digest sample and break viscosity) and analyzed using Graphite Furnace Atomic Absorption Spectrometry (GFAAS). Aqueous and Solid samples were prepared using microwave assisted digestion and analyzed tiring Inductively Coupled Plasma Atomic Emission Spcctomctry (ICP-AES). All Samples were run in duplicate and average answers reported. In the case ofthe blood, each sample and duplicate was spiked and checked for recovery. Ifthe spike recovery was greaterthan 10% in error, a one point standard additions calculation was performed. Methodology The descriptions listed below are summaries ofthe actual methods used to analyze samples. The actual methods are documented in the GUP Protocols Notebook, archived at QCL and copies are available upon request Sample Preparation: Blood Blood samples were received in small polyethylene vails. Approximate ample volume- was 100-300 riL. 100 uL ofblood is diluted to 1.0 mL with modifier solution. The modifier solution is a solution ofnitric arid (digests sample), Triton X-100 (surfactant,' breaks viscosity), methanol (antifoaming agent),.and.ammoniumphosphate (GFAAS - modifier) in water. Sample Analysis: Blood Blood samples are analyzed using GraphiteFurnace Atomic Absorption Spectrometry (GFAAS). In GFAAS, a 20 microliter volume ofsample + modifier is injected into a Small: graphite tube. This tube is electromagnetically heated to dry, char, and atomize the sample. A hollow cathode lamp (HCL) shines fight corresponding to the atomic emission ofPb (283.3 nm) through the tube. As freePb atoms are generated by the sample atomization, they absorb the radiation, attenuating the amount ofsignal from the HCL. The degree ofattenuation ofthe HCL radiation is proportional to the concentration ofPb in the sample. Calibration standards of 10,20 .and 30 ng/mL are prepared by serial dilution ofa 1000 ugfmL stock. Each blood sample is analyzed twice. Each sample and duplicate is then spiked with 10ng Pb and reanalyzed to check for recovery. Ifrecovery is less than 90% or greater than 110%, a one point standard addition calculation is -89- DUP040005135 Lead Analysis Report #1: Soils AEC 3-3, AEC 9-3, and AEC 10-1 DuPontHLR 581-94 performed to determine the amount ofPb in the sample. Each result is the average ofthe two replicates. Sample Preparation: Aqueous Samples Samples that are primarily aqueous are prepared by acidifying 10.00 mL ofsample with 2.00 mL concentrated HN03. The sample is then diluted to a final volume of20.00 mL and analyzed by ICP-AES. Sample Preparation: Solid Samples Solid Samples are prepared by microwave assisted digestion. 0.1 - 0.2 g ofsample are digested with 5.00 mL concentrated HN03 in a Teflon lined pressure vessel. The vessels are placed in a microwave digestion apparatus and cooked for 10 minutes at 300@W power. The samples are allowed to cool and are then Altered into a 50 mL volumetric flask and dilutedto volume with deionized water.- Samples are analyzed for Pb content by ICP-AES. Sample Analysis: Aqueous and Solid Samples These samples are analyzed by XnducflvdyCoppled Plasma- Atonnc Emission . Spectrometry (ICP-AES).' The prepared samples are pumped into an sample introduction system where a fine spray ofaerosol is generated. This sample aerosol flows along a stream ofargon gas into the plasma. The plasma is a highly energetic discharge sustained in argon by applied radio-frequency power in excess of1000 W. Tins discharge is emission. The intensity ofthe characteristic emission wavelength ofPb (220.35 nm) is proportional to the amount ofPb inthe sample. ____ Results The results for all samples submitted under MR9727-001 are listed in AppendixX -90- Lead Analysis Report #1; Soils AEC 3-3, AEG 9-3, and AEC10-1 DuPont HLR 581-94 205] . 263! PB__PHS2.XLS MR 9727-001 Page 1 OF 2 o CO ps CO :r- Ps CM CM O 00 CO <o CO <0 o Ps to CO <0 CO CM 9" CM r o 03 fs CM to 01 ps 9-* .'W" CO to 9" 9 CO o cm U3 cm o st- <n tc 00 CM s CM CO O) 9" 03 ID to 03 CD CM CM CO ps 9" 9" r> 9" to st to V uo Q. c m D cOc C3 Is* Ps o St ps. 8 O CD 9" in co CM 1 00 St r* 03 O) 03 r> CD CO 09 8 CD <0 CM tO V o CM W CO St CO CO 00 CM st st <0 CO Ps S* 0> CO 00 to CO to o ps CO x-- .00 ps 3 oj c ( d .JZ a> vt UJ o 2 a H al St 00 CM ip" st CM CO *t CM p* CD a) o CM st st CM 03 1 ** T* 9**. to o st 00 CM U) CM 3 CO 2 03 to o CO CM 9" ps CM CM to V st o 9t --- 9" CO 9" Ps CO CO 9t. 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CM CM o 00 .V* CO CO 9" O ) CO Ps Ps to V O rs CD o U) rto o o> 9"" CO l*s O st CO CO CO O) to O) CO P* CO T st. co 03 % CM: CM 00 r* Tm to st U3 -- st CO 9" o CO p 09 CM O CO *0* CO CM CO cn CO to too CO 03 9 03 T" St CO -T- o CO 3 o CO CM CP CO CO w St CO o CO CO CM CO 5 to 00 CM to 03 9* to CO 9** CM 03 fs 00 CO to 9-- 5a a. 3 O CC a Ui to o CM i*i CM 00 CM CO CO CO ID st CO 9-- COM CO CO CO to Ps to CM o CO 00 CO % P to o to o 3 0) r> CM CM 9TM o CO o CO o CM o 9" CM to o co CO st CO CO st v* to o 9-- 00 to 5 CO ps LO to e ac ID V 5 ID r" CM St 00 CM *-- st CM CO st CM Ps CO 03 o CM st st CM 03 ui o 2 *a '1- CO o CO o 8 CM 8 St o Ps CD CM ors CM o CO ps 9~ o to o to 03 P> CO r* to 03 to CO Ps 03 CM to V o CL CM oco 3 Q CC O Oo st CM o CO St 8 CO co o 03 03 9" CM CO o CO o 9" to 0) 2 CO CM r* to 0> $ T to V 9" o CO 3 00 O CO 3 8 CO 9-- 8 CO CM 00 CO to st 00 p> CO Ps 9 sp <r CM 03 CM CO CPMs CO 5 03 C ? to 9" CM st 09 CM d 9" 00 CM CO st Ps 03 f w tu 0 12 t-- ? -91- DUP040005137 DUP040005138 -92- to V CO CM CM cn to OOO CM CM CM GO ca ca DC Q aa.i I 96 1 S______ S>| tros 03 CM 5 iTImo IC305 RPT Vi o *o <D 1 0.5 1 1 1 1 1 ' 72 1 1 1 120 1 1 144 -s** cn 169 809 64 107 129 128 58 O CO CoM O CM 1% 03 CO CO to U) CM CO to ,r" jO O <<< o r-- < < << CO CO O O** 0or*3 oto r* CM CM fs CM i |A10S-8 | IA103-12 | IA103-24 | IA102-144 | oo o CO T* to rs CO CM <*> CM CM 6031 3121 5981 1561 80| to to VV to o *-- ! CM CM ca 03 CM O IN. CD CO IB202-2 I 296! 03 03 3 4 r* to o CoM 0o1 CO CO CJ o % O CO o IC304-1 IC302-4 IC303-4 IG303-8 1 670 1 200 1 1870 1 1670 1 ; 1070 --- -- - o CO CO CM .r- CM I I C 3<3 sa zoz a o -- 5 D< s! 309 5 1969 I lets | 96S I CM O lAECIO-1 CO a> a < lAEG 3-3 i IPIG DOSE 1 (AEG 3-3) IPIG DOSE II (AEC 3-3) COM CM CM IGRPII 203 | 10 O K DC <P |#401 I 1 616 1 613 1 686 1 1686 1 1776 1 1411 I 884 1 603 1 763 1 621 I 385 1 6361 mCoTO" CO cTn* <tO 0oto>3 <0 O 1 to VVVV ASPEN LAB SHAVINGS BASAL CHOW I NITRIC ACID 1 Pb ACETATE DOS. S0LN Pb SOIL 9-3 f Pb SOIL 10-1 1 Pb SOIL 3-3 1 1 CTM~ CD I o CtoD 46901 51591 48661 52351 50931 20921 'c m CO CM 0) CO 03 tooo CM CM CM CM Cr>O C*--O Cor*O 17871 16681 3 -- -- - - - -- - Lead Analysis Report #2: Soils PLW and EC1 DuPont HLR 581-94 Analysis ofPb in Blood, Soil, and Associated Materials in Support ofHaskell Lab Medical Research ProjectNo. NEEL 9740-001 Author Keith A. McCleary Study Completed: 1/26/94 Performed By: DuPont Specialty Chemicals Trace Metals Analysis Group Quality Control Laboratory Chambers Works "Deepwater, NX 08023 Signature: Keith A. McCleary, Pn.D. Date. -93- DUP040005139