Document qaV0x9Z9y8zKybdp3YEQY1yzj

Monsanto J. D. Hinchen - T3A - 4-4869 T| August 25, 1981 MMIIHCI Statistical Analysis of PCB Content of Monkey Tissue (S-81-SS-2)__________ TO : J. H. Craddock - A2SA P. E. Berteau - G2M) B. J. Warner - 1250 G. J. Levinskas - G2WF P. R. Michael - N1E Attached is a summary of the statistical analyses performed on the data from Beverly turner's report "PCB Content of Monkey Tissue," M0A-041, May 7, 1979. This Information may be used as a section of any further reports by MRC or DMEH, or as a starting point for additional statistical analysis as needed. JOH :bjs attachment IN 10 *iV .??> HONS 022370 Statistical Analysis of PCB Content of Monkey Tissue introduction This report covers the statistical analysis of analytical data collected from a subacute feeding study on the concentrative effects of polychlori nated biphenyls on adult Rhesus monkeys and their offspring. (Report M0A-041, "PCB Content of Monkey Tissue" - Beverly J. Hamer, 7 May 1979). The following description of the study is the introduction from that report. "This study is designed to determine the concentrative effects of poly chlorinated biphenyl (PCB) compounds in a subacute feeding program in volving forty-eight adult Rhesus monkeys and their subsequent offspring. The Rhesus monkeys were fed Aroclor 1254 (a PCB compound composed of 12 carbon atoms and 541 chlorine per PCB molecule) as a supplement to their diet. The feeding study was conducted by Litton Blonetics, Kensington, Maryland, for a period of one year. Fat tissue biopsies of the adult animals were taken by the Litton Laboratory and shipped to MRC for the analysis of PCB content periodically during the feeding study (approxi mately every two months) and during an eight-month relaxation period following the feeding study. In addition to the adult fat samples analyzed, numerous Infant skin and fat samples, and colostrum (milk), placenta, and blood serum samples were analyzed on an Intermittent basis. At the termination of the project, liver biopsies were also provided for all adult animals and several Infants. In all, In excess of seven hundred Individual analyses were performed for PCB by various extraction techniques followed by electron capture gas chromatography (EC-GC). The analysis technl ques utilized and the data accumulated are presented in the following sections of this report." The statistical analysis centers primarily on the adult fat and adult liver samples which had relatively complete and well-balanced data. No samples were excluded. Data were not complete for the baby skin, baby fat and milk samples, but these are presented for Inspection, with statistical analyses where applicable. All the data treated were assumed to be log-normally distributed, and averages and confidence limits were calculated on this basis and converted back to the original scale. SUMMARY OF RESULTS Adult Fat Samples (male and female) PCB level In adult fat samples for animals fed the highest amount of PCB is significantly higher than control from one month through 20 months. Average PCB In tissues for this period Is 28.2 PPM (wet weight basis) and 53.5 PPM (lipid weight basis). MOMS 022371 S-81-SS-2 Page 2 PCB level In adult fat samples for animals fed the medium level of PCB is significantly higher than control from 4 months through 20 months. Average PCB in tissues for this period is 13.2 PPM (wet weight basis) and 20.5 PPM (lipid weight basis). PCB level in adult fat samples for animals fed the low level of PCB is significantly higher than control from 7 months through 20 months. Average PCB in tissues for this period is 2.8 PPM (wet weight basis) and 4.2 ppm (1ipid weight basis). PCB level In adult fat samples for control animals (no PCB fed) averaged 0.30 PPM (wet weight basis) and O.SS PPM (lipid weight basis) for the period from 1 to 20 months. Adult liver Samples - 20 Months (male and female) PCB level in adult liver samples increased in proportion to the amount fed. On a wet weight basis, the control samples averaged 0.076 PPM, low level samples averaged 0.4 PPM. medium level samples 0.81 PW and high level samples 2.43 PPM. 'On a lipid weight basis, these results were 2.2 PPM, 10 PPM, 23 PPM and 7S PPM respectively. Baby Skin Samples PCB levels found in baby skin samples Increased with Increasing PCB in parents' diet, and with sampling time up to 7/31/78 (insufficient data for statistical analyses). Bibv Fat Samples PCB levels found In baby fat samples increased with increasing PCB In parents' diet, and with sampling time up to 7/31/78 (Insufficient data for statistical analysis). Milk Samples There was a significant Increase of PCBs In milk as a function of the PCB level In the feed. The data were too widely scattered to determine what kind of model best fit the data. The linear model gave the following equation: Amt. PCB In milk 0.094 0.0097 (amt. PCB fed). The correlation coefficient was 0.92, significant at 99.9t P<0.001. DESCRIPTION OF STATISTICAL APPROACH Adult Fat Samples - Met Height and Lipid Height Basis Table I shows the output from a computer program which calculates the 951 confidence limits of the mean of the amount PCB found In the adult fat samples. The program converts the data to logarithms, calculates the mean HONS 022372 S-81-SS-2 Page 3 and standard deviation of PCS found for each level fed at each sampling time, then calculates 95X confidence limits of the means of the logarithms. This information is converted back to PPM, and 95* confidence limits of the mean are reported In PPM and as percent of the mean. [t Table II Is a summary of the averages by month for each level of PCS fed. Table III gives specific statistical conclusions by month. Figures la and lb are composite plots of the means and 95* confidence limits of PCD found for each level fed vs. sampling time. The test for significance was based on the degree to which the 95* confidence limits of the means overlapped. The least significant difference (95* level) between the means Is approximately 2.828 standard deviations, tlien there is no overlap of the 95* confidence limits, the means are approximately 4 standard deviations apart. The Individual comparisons can be confirmed using Students' t test. Adult Liver Samples - End of Study The procedure for calculating confidence limits of the means is the same as In Adult Fat Samples. Figures 2a and 2b show the means and confidence limits of the means for PCEs found at each level of PCB fed. Least squares lines were determined for the average PC8s found vs. amount PCB fed. For lipid weight samples PPM found (lipid) * 4.6 + 0.21 (PPM In feed). For wet weight samples PPM found (wet) 0.20 + 0.022 (PPM in feed). Both these equations were significant at 99.9* (p<0-001) Baby Skin Samples Table IV shows average PPM found on wet weight basis In baby skin as related to level fed to parents, and sampling time. Lipid weight results are not shown because of extreme variation In lipid weight to sample weight ratio. Babv Fat Samples Table IV shows average PPM on wet basis, presented as Indicated In paragraph under Adult Fat Samples. Milk Samples Table V shows the average PPM found In milk samples, presented as related to PCBs consumed. HONS 022373 S-81-SS-2 Page 4 discussion The foregoing analysis of the data Is an attempt to describe the effects of various levels of PCB in the diet on the resulting amount of PCB found In the animal tissues. No attempt was made to fit any sort of theoretical model, but the adult fat data may be sufficiently consistent to support such an approach. In addition, we have not tried to relate PCB levels to toxicology data, but recommend that this be done when the latter are available. ACKNOWLEDGMENT The assistance of J. L. Davis (Environmental Sciences) in running the computer calculations of means and confidence limits is gratefully appreciated. HONS 022374 TABLE I Calculation of Confidence Limits - -f.Nr-.r,. aiT MF AN * MOi.Qj "' S* <5 SIGMA' ["ITS ->F 572997 rn 95'. LIMITS AS X OF MEAN-ASS / ro i',o 7 13 0791,1 X S-31-SS-2 Page 5 TABLE n LOM 'JET i-EAN m 495098 95X (2 SIGMA' CONEIDENCE I EMITS ARE 3S3A TO 4,9361I 95% LIMITS AS X OF MEAN APE 71.3797 X TO 140 096 X TABLE 6 MEDIUM WET MEAN .58504? 95X <2 SIGMA) CONFIDENCE LIMITS ARE. 39595B TO 864421 9SX LIMITS AS X OF MEAN ARE 67 4,802 X TO 147 754 X TABLE s HIGH UFT MEAN 688215 9SX <2 SIGMA) CONFIDENCE LIMITS ARE 3634 TO 1 30336 5X LIMITS AS X OF MEAN ARE 52.8032 X TO 189 382 X TABLE 6 CONTROl LIPID MEAN - l 71629 5X <2 SIGMA) CONFIDENCE LIMITS ARE 361068 TO 8 15809 95X LIMITS AS X OF MEAN ARE 21 0378 X TO 475 335 X TABLE 6 LOW LIPID MEAN 76315 95X (2 SIGMA) CONFIDENCE LIMITS ARE 4718S2 TO 1 23428 95X LIMITS AS X OF MEAN ARE 61 8296 X TO 161.735 X TABLE 6 MEDIUM LIPID MEAN 915273 95X <2 SIGMA) CONFIDENCE LIMITS ARE 524646 TO 1 59674 9SX LIMITS AS X OF MEAN ARE 57 3213 X TO 174.455 X TABLE 6 HIGH LIPID MEAN .953255 95X <2 SIGMA) CONFIDENCE LIMITS ARE .443374 TO 9SZ LIMITS AS X OF MEAN ARE 46.5116 X TO 215 X 2.0495 TABLE 7 CONTROL. WET MEAN > 235899 5X <2 SIGMA) CONFIDENCE LIMITS ARE .109157 TO 509798 95X LIMITS AS X OF MEAN ARE 46 273 X TO 216.109 X TABLE 7 LOW WET MEAN .422009 95X (2 5ICMA) CONFIDENCE LIMITS ARE c 391 TO 7630S9 95X LIMITS AS X OF MEAN ARE 55.3049 X iU 180 816 X TABLE 7 MEDIUM WET MEAN - 1.23347 5X <2 SIGMA) CONFIDENCE LIMITS ARF 461048 TO 3 29998 95X LIMITS AS X OF MEAN ARE 37 3782 X TO 267 S36 X HONS TABLE 7 HIGH UFT MEAN - 10 9164 ni SBPIRIJISeAkiMi;i.a!7 Z?4lsUl59lf 4531 022375 '*m_E 1 control I.to; o nFAN * 3879f> o<?X 1.3 SIGMA) CONFIDENCE LIMITS APE 140003 TO 1 i,)) SX LIMITS AS X OF MEAN ARE 36 3325 X TO 375 336 X ' S-31-SS-2 Page 6 TABLE 7 LOU LIPID ME AN ,534001 9SX <2 SIGMA) CONFIDENCE I IMITS ARE 297713 TO 994604 9SX LIMITS AS X OF MEAN ARE 54 344) X TO 194 3S1 X TABLE 7 MEDIUM lipid MnErwANi 2c . 11 39935 %\l ^{"31 S^f'RiSSW^Sl.iSIs X6^38?27T?637X00,M TABLE 7 HIGH LIPID MEAN 14.1906 9SX (2 SIGMA) CONFIDENCE LIMITS ARE 6 8624 TO 29 303 95* LIMITS AS X OF MEAN ARE 48.3939 X TO 206 642 X TABLE 8 CONTROL WET MEAN S1S02S 95X 12 SIGMA) CONFIDENCE l IMITS ARE 380366 TO 6973S5 9SX LIMITS AS X OF MEAN ARE 73.854 X TO 135 402 X TABLE 8 CONTROL LIPID MEAN a .654461 9SX (2 SIGMA) CONFIDENCE LIMITS ARE 458312 TO 934557 95X LIMITS AS X OF MEAN ARE 70 029 X TO 142 798 X TABLE 9 CONTROL UET MEAN .881472 SX <2 SIGMA) CONFIDENCE LIMITS ARE S98969 TO t 29722 9SX LIMIT9 AS X OF MEAN ARE 67.9SI X TO 147 165 X TABLE 9 LOW UET MEAN a 964053 9SX (2 SIGMA) CONFIDENCE LIMITS ARE S50077 TO t 68958 9SX LIMITS AS X OF MEAN ARE 57.0S88 X TO 17S.258 X TABLE 9 MEDIUM UET MEAN 5 99341 95X (2 SIGMA) CONFIDENCE LIMITS ARF 4 01158 TO 8 95433 95X LIMITS AS X OF MEAN ARE 66 9331 X TO 149 403 X TABLE 9 HIGH UET MEAN a 200999 5X (2 SIGMA) CONFIDENCE l IMITS ARE 14 3207 TO 28 21 13 9SX LIMITS AS X OF MEAN ARE 71 2475 X TO 140.356 X TABLE 9 CONTROL LIPID SIS- <2 StSilA''CONFIDENCE LIMITS ARF 819999 TO 1 87713 95X LIMITS AS X OF MEAN ARE 66.0531 X TO 151 393 X TABLE 9 LOM LIPID HEAN * 1 96490 SX (2 SIGMA) CONFIDENCE I IMITS ARF 95486 TO 4 04372 9SX LIMITS AS X OF MEAN ARF 48 5036 X TO 205 788 X MONS 022376 r*Pt_E ' "K HUB L ID n*-* ) 6Hb7 jc?. <2 SIGMA) CONFIDENCE I INITS ARE 4 6SIS r0 13 J444 45X LIMITS AS X OF rlEAN rtRE 61 1'43 X TO H3 374 x S-9IRig TABLE 9 HIGH LIPID MfN * 3*22.((1111339 957 <3 STGMA) CONFIDENCE I INITS ARE 21 8113 TO 47 nnc; S7 LIMITS AS X OF MEAN ARE 68 tSOl X TO 146 735 X TABLE '0 CONTROL UF.T MEAN * 347594 5X (3 SIGMA) CONFIDENCE LIMITS ARE 0792736 TO 77311s 951 LIMITS AS 7. OF MEAN ARE 32 0172 X TO 312 3.12 7. TABLE 10 LOU UET MEAN 440969 SX (2 SIGMA) CONFIDENCE LIMITS ARE 180674 TO 1. 07637 5X LIMITS AS 7. OF MEAN ARE 40.973 X TO 744 069 * TABLE 10 MEDIUM UET MEAN 7 4S8S2 SX <3 SIGMA) CONFIDENCE LIMITS ARE 5. 48_ 193 TO 10 1478 9SX LIMITS AS % OF MEAN ARE 73 4909 X" T"O 136 057 X TABLE 10 HIGH UET MEAN 24 3932 95X <2 SIGMA) CONFIDENCE LIMITS ARE 14 2319 TO 41 8095 95% LIMITS AS X OF MEAN ARE 58 3437 X TO 171 398 X TABLE 10 CONTROL LIPID MEAN 412967 9SX <2 SIGMA) CONFIDENCE LIMITS ARE 127B52 TO 1 3339 95X LIMITS AS X OF MEAN ARE 30 9S9S X TO 323.003 X TABLE 10 LOU LIPID 3IS*<| SiSmI?*CONFIDENCE LIMITS ARF 262462 TO t 74929 9SX LIMITS AS X OF MEAN ARE 38.7349 X TO 258 16S X TABLE 10 MEDIUM LIPID MEAN 8857S4 SX (2 SIGMA) CONFIDENCE UNITS ARE 6 38339 TO 12 2906 9SX LIMITS AS X OF MEAN ARE 72.0673 X TO 138.759 ? TABLE 10 HIGH LIPID MEAN 35.6465 95X <2 SIGMA) CONFIDENCE LIMITS_ A...R..F 16.7222 TO 75 9958 9SX LIMITS AS X OF MEAN ARE 46.9--0--8--5 X TO 213 181 X TABLE 11 CONTROL UET MEAN 162668 99S5XX L<I2MSITIGSMAAS) CX OONFFIDMEENACNEARUENIT6S2 A7R23E4 X.10T2031159 TO43 X 259342 TABLE 11 LOU UET MEAN 2.50308 *SX (2 SIGHA) CONFIDENCE I IMITS ARF 1 82661 TO 3 41007 V5X LIMITS AS X OF MEAN ARE 72 9746 7. TO 137 1)34 X HONS 02237 TABLE tl MFDPJM WFT MEAN a A 48146 OF* I a STGMA) CONFIDENCE I IMITS ARE 9SX LIMITS AS X OF MfcAN ARE 68 7572 83161 TO 12 3354 TO 145 439 X table n high uf.t HFAN a 30 5028 95X, <2 SIGMA) CONFIDENCE I IMITS ARF 10.4364 tq 40 2786 95? LIMITS AS X OF MEAN ARE SO 9023 X TO 196 ASS X TABLE H CONTROL LIPID MEAN 213713 9SX (? SIGMA) CONFIDENCE I IMITS ARE 122103 TO 374053 9SX LIMITS AS X OF MEAN ARE 57 1344 X TO t7S 026 X S-8I-SS-2 Page 8 TABLE 11 LOW LIPID MEAN a 2.77841 9?x (2 SIGMA) CONFIDENCE LIMITS ARE 1 803266 TO 4 2P089 9SX LIMITS AS X OF MAN ARE 64 9027 X TO 1 54 077 X TABLE 11 MEDIUM LIPID MEAN a 11.5644 95X <2 SIGMA) CONFIDENCE LIMITS ARE 7.8SS42 TO 17.0182 9SX LIMITS AS X OF MEAN ARE 67 9S33 X TO 14) 16 X TABLE 11 HIGH LIPID MEAN - 30 0384 9SX (2 SICHA) CONFIDENCE LIMITS ARE 11.8584 TO_ 76.09 9SX LIMITS AS X OF MEAN ARE 39 4775 X TO 253 309 X TABLE 12 CONTROL WET MEAN a 728571 95X (2 SIGMA) CONFIDENCE LIMITS ARE 407622 TO 1 30222 9SX LIMITS AS X OF MEAN ARE 5S 9482 X TO 178 737 X TABLE 12 LOU WET MEAN a 2.88638 95X <2 STGMA) CONFIDENCE LIMITS. A...R..F. 2 14402_ TO 3 88577 95X LIMITS AS X OF MEAN ARE "74* .2--8--0--8 X TO 134 624 X TABLE 12 LOU UF.T mean 2 88638 SX (2 SIGMA) CONFIDENCE LIMITS ARF. 2.14402 TO 3 88577 9SX LIMITS AS X OF MEAN ARE 74 2808 X TO 134 624 X TABLE 12 MFDIUM UF.T MEAN 95X <2 12 4318 SIGMA) CONFIDENCE I IMITS_ ARF 8 79351 TO 17 S7SS 9SX LIMITS AS X OF MEAN ARE --70 "73"39 % TO 141 375 X TABLE 12 HIGH UFT MEAN a 5? 9365 95X <2 SIGMA) CONFIDENCE I IMITS ARE 28.8245 TO 55 3324 9SX LIMITS AS X OF MEAN ARE 72.1757 X TO 138.551 X TABLE 12 CONTROL LIPID MEAN a 1 0385 95X (2 SIGMA) CONFIDENCE LIMITS ARE 530677 TO 2.0 9SX LIMITS AS X OF MEAN ARE 51.1003 X TO 1S 694 X HONS 022378 'ifi.e I ; j'-t L10 ID HP AN 4 3'M)31 '-'X (? 5 f ON A t CONFIDENCE IHIT3 ARP 3 ?13 Tn ni.ea 'S3 limits ns x of dean are os 4545 : to i?o 473 : TABLC 13 MFOIUM LJPID MEAN 17 531 a S3 <3 SIGMA) CONFIDENCE ' IMITS ARE 11.3194 TO 36 S3R 953 LIMITS AS 3 uF MEAN ARE 65 .5096 X TO 153 117 3 TABLE 1' HIGH I IPTD MF AN 7 0047 993 (.? SIGMA) CONFIDENCE I IMITS ARF 50.0066 TO 165 33? >5`. 11 ) - -5 x OF MEAN ARE 59 37S.3 X TO 168 705 X `aSM.ff ) rriturvO- r r(. >,*>1 s jV j'- J ' [DPni>` ' '.iii.TS ARF .288679 ro 479911 -'V, L'r*i S \ OF r*EAw mkE aiw` % TO 128 801 X "AALi 1 L-'W UF T `'tifJ a * jui-p , > srr.jnai confiofni'* 1 :rrT5 9 71)744 LIMITS S v: i)F MEAN mP 7*) f)632 X TO :n 9 c.c^s 739 : r^BLE 11 MFDI'JM WF T * ? S 1*?3 , 9 crr.no; cpnFCDFWCF * [MITS APC 40 7-6 r*< 7') **; LIMITS AS X UF rt*N *PF 78 l *'** * ro ,;.7 945-3 v r**L * 3 HIGH WFT hn * id 9255 <X *2 Slurm.* CONFIDENCE LIMITS ARF 9SX LIMITS AS X OF MEAN ARE 50 5377 6 ' > TO TABLE 13 CONTROL LIP tD ->n 512762 ><X <} `-fONAi CONFIDENCE LIMITS ARF 337241 TO 1 . 18724 95% LIMITS AS % OF MEAN AR 53 2967 X TO \7 629 X TABLE 1 3 LOU -WW ; Mf AN 5 6438 *SX <2 SIGMA) CONFIDENCE LIMITS ARF 3 20953 tq *SX LIMITS AS X OF MEAN ARE 56.8682 X TO 175 9*>a a X S-8T-SS-2 Pag* 9 "FAN 23 5652 *5X 9SX (2 SIGMA) LIMITS AS CONFIDENCE 1 IMITS X OF MEAN ARE 70 A4R~894.9 X18 TO 33 4306 41864 X TABLE 13 HIGH LIPID MEAN 114 285 9SX <2 SIGMA) CONFIDENCE LIMITS ARE 62.6862 TO 208. 357 9SX LIMITS AS X OF MEAN ARE 54.8507 X TO 182 313 X TABLE 14 CONTROL WET MEAN 292217 *X <2 SIGMA) CONFIDENCE I IMITS APE .139416 TQ 61249? 95X LIMITS AS % UF MEAN ARE 47.70*6 X TO 209 6' 01 X HONS 022379 TABLE 14 LOU WET MEAN 3 35533 95X 12 SIGMA) CONFIDENCE LIMITS ARF 2 1*354 TO 5 13?** 9SX LIMIT9 AS X OF MEAN APE 6S.3748 X TO 1..5...2. ..6...4......X TABLE '* nFDtUH UFT MFAN * 20 2384 ASX <2 SIGMA) CONFIDENCE I IMITS ARF 10 7382 TO 38 1434 9SX LIMITS AS 7. OF MEAN ARE S3 0587 7. TO 188 471 * TABLE 14 HIGH WET mFan RS 8265 ->SX (2 9TGMA) CONFIDENCE 1 IMITS ARF 70.9S61 TO 129 419 953 LIMITS AS 7. OF MEAN ARE 74 0465 7. TO 135 05 7. TABLE 14 CONTROL I. IP ID MEAN 644225 9<X <2 StGMA) CONFIDENCE LIMITS 9S% LiHITS AS X OF MEAN ARE 23 ARE 1511 4698 X TO 426 3 07? x TABLE 14 LOU LIPID MEAN * 6 32952 9S7. (2 SIGMA) CONFIDENCE LIMITS ARE 3 53561 TO 11 3312 SX LIMITS AS X OF MEAN ARE 55 8591 X TO 179 022 Z TABLE 14 MEDIUM LIPID MEAN 28 9138 95X <2 SIGMA) CONFIDENCE LIMITS ARE 12 8817 TO 64 8987 9SX LIMITS AS X OF MEAN ARE 44.5522 X TO 224.4S6 X TABLE 14 HIGH LIPID Six*<2 SIGMA? CONFIDENCE LIMITS ARF 103.773 } 264 04 9SX LIMITS AS X OF MEAN ARE 62 6913 X TO 1S9 12 X TABLE IS CONTROL WET MEAN - 129589 ?5X <2. SIGMA) CONFIDENCE.LIMIT ARE 059196 TO 283689 95% LIMITS AS % OF MEEiAN ARE 45 6799 X TO 218 1S X TABLE 15 LOU UET MEAN 2 20322 m m"2! igEFisi2SEAMi;s.tSi kwn.141T.7O84 3 X 1238 TABLE IS MEDIUM WET MEAN a i5 8502 9SX <2 SIGMA) CONFIDENCE LIMITS ARE 10 5148 TO 23 893 95X LIMITS AS X OF MEAN ARE 66.3385 X TO 150 742 X TABLE IS HIGH WET 9SXN<2 SIGMA) CONFIDENCE LIMITS ARF 28 537 TO 62 760 9SX LIMITS AS X OF MEAN ARE 67 431 X TO 148.3 X TABLE '5 CONTROL LIPID Sr^M#?! .$55* x"?S7S^9 Ih x69M8A S-8I-SS-Z R*ge 10 TABLE <5 LOW LIPID mfm * 3 93395 X <2 SIGMA) CONFIDENCE I IMITS ARF 2.2130S TO 6 99304 98\ LIMITS AS t uF nEAN ARE S6 2SS2 X TO 177.761 X HONS 022380 3 "rj ' SCCiiO 'Imp \ C1 cr 'J '*SX UNITS AS X OP mEa* ;n [ r 3 ^k " ' ?! -`s 0*'^7 *-ss r4*L IS HT GH I IP ID KAN * lift 175 *5X (2 SIGMA) CONFIDENCE I [HITS ARF )2tft T-i 149 9V-: LIMITS AS % OF MEAN ARE 61.219ft Z TO 1*3.347 X t4BLE 1ft CONTROL 'JET rtPAN * 13077.1 *SX 13 ST.GNAI CONFIDENCE l IMITS ARE 07*4903 TO 181494 VSX UNITS AS X OF MEAN ARE 65.8101 X TO 1 Si 914 X TABLE 16 LOW-WET MEAN * 13 0617 9X <2 SIGMA) CONFIDENCE LIMITS ARE 9 65428 TO 17 6717 9SZ LIMITS AS X OF MEAN ARE 73.913 X TO 133 294 X TABLE 16 HIGH WET MEAN 10 0199 5X (2 SIGMA) CONFIDENCE LIMITS ARE 4.30106 TO 23.3305 9SX LIMITS AS X OF MEAN ARE 42.933 X TO 232 991 X TABLE 16 CONTROL LIPID MEAN 334? SX <2 SIGMA) CONFIDENCE LIMITS ARE 223399 TO 5020S3 95% LIMITS AS X OF MEAN ARE 66.7061 X TO 149 911 X TABLE 16 MEDIUM LIPID HFAN * 24 9736 3! fH?Kna i7t394?43T7 F 854* S-3T-5S-2 Page 11 TABLE 16 HTCH I..IPID HFAN 14 S144 95X (2 SIGMA) CONFIDENCE I IHITS ARE 17.3062 TO 68 8134 9SX LIMITS AS X OF MEAN ARE SO 141? X tfl 199 434 X TABLE 18 CONTROL WET HF AN . 434785 SX (3 SIGMA) CONFIDENCE LIMITS ARE 243S76 TO 776094 9SX LIMITS AS X OF MEAN ARE 56 0222 X TO 178 SOI X TABLE 18 LOU UFT MFAN 3.02133 SX (2 SIGMA) CONFIDENCE LIMITS ARE 2 55449 TO 3 57349 95X LIMITS AS X OF MEAN ARE 84.54B4 X TO 118.275 X TABLE 18 MEDIUM WET MFAN IS 5034 5Z <2 SIGMA) CONFIDENCE LIMITS ARE 10,3717 TO 239SX LIMITS AS X OF MEAN ARE 66 8996 X TO 14`9* 4` 78 1741 TABLE IB HIGH UET MFAN - 43.2059 95X <2 SIGMA) CONFIDENCE LIMITS ARF 21 9233 TO 85 l9S 5X LIHITS AS X OF MEAN ARE 50.7413 X TO 197 1)78 X HONS TABLE 1.0 ..... . LIPID HEAN 1 48024 95X (2 SIGMA) CONFIDENCE I IHITS ARE 6698 TO 3 27131 9SX LIMITS AS X OF MEAN ARE 4S 2493 X TO 220 990 X 022381 TABLE 18 LOW LIPID MEAN S 06448 95X I? SIGMA) CONFIDENCE 1. IMITS ARE 4 22522 TO 6 07049 95? LIMITS AS X OF MEAN ARE 83 4284 X TO H 863 X ' TABLE 13 MEDIUM LIPID MEAN 38 58 **7. '3 SICMA1 CONFIDENCE ! IMITS ARF 16 . SOS'7 TO 90 ">344 *SX LIMITS 45 7. OF MEAN ARE 42 7,,S2 X TO 2J3 83S X ~ TABLE 18 H TCH LIPID M|jj|N(- ?7_08S7 95* (2 SIGMA) CONFIDENCE I IMITS ARE 45 5477 TO 206 94 9SX LIMITS AS X OF MEAN ARE 46 9149 X TO 213 1S2 X TABLE 19 CONTROL WET MEAN - 4.36251 ?2 *3?37i3iT2S2 !72<588 IhE.lS Will" 95X (2 SIGMA) CONFIDENCE tIMITS ARF 1.82215 TO 2 90364 95X LIMITS AS X OF MEAN ARE 79.2174 X TO 126 235 X TABLE 19 MEDIUM WET MEAN - 14 0178 95* <2 SIGMA) CONFIDENCE I IMITS ARE 9 40518 TO 20 8927 95* LIMITS AS * OF MEAN ARE 67.0944 X TO 149 044 X TABLE 1 HIGH WET MEAN 32.4199 9SX (2 SIGMA) CONFIDENCE LIMITS ARE 24.127 TO 43 5633 95? LIMITS AS X OF MEAN ARE 74.4202 X TO 134.372 X iaBLE 19 CONTROL LIPID MEAN >3 0'79 < > STOMA) '-ONFIDENCE LIMITS ARE 332683 TO 2 60413 95X LIMITS AS X OF MEAN ARE 35.7484 X TO 879.78 X TABLE 19 LOW LIPID MEAN 2 94958 95X (2 SIGMA) CONFIDENCE l IMITS ARE 9SX LIMITS AS X OF MEAN ARE 77.995 30066 TO 3 TO 129 206 X TABLE 19 MEDIUM LIPID MEAN 17 2633 95X (2 SIGMA) CONFIDENCE LIMITS ARE 11 6183 TO 25 651 95? LI MI T'3 AS X OF MEAN ARE 67.3007 X TO 148.587 X TiOl - 1 9 HIGH I IPID MEAN 43 6318 ? <2 5TGMA) CONFIDENCE ! EMITS ARE 31.0827 TO 61 2473 95X LIMITS AS X OF MEAN ARE 71.2 M? 3 TO 140 373 X S-81-SS-2 Pjge 12 HONS 022382 w FIGURE la PPM - Met Weight Basis U 6d FIGURE 1b PCB In Adult Fit Staples - Lipid Might Basis Weight Basis PPM PCB - l l j l d JPage * ttftLIL . ?a _ tJt_Su.ll Lm motm T6l* * l*6l 7 1*61* 9 1*61* 10 U6I* 11 im. 4 *, 7 Mi. U6l 12 9 N*. 1*6I 13 (t! 14 II N*. 13 Na. I6lt 16 W61* 16 14 Mi. 16 Mi. 0.741 0.496 0U1 0.600 0.236 0.422 1.233 10.916 0.601 0.964 6.903 20.100 0.240 0.441 7.469 24.393 0.163 2.603 0.401 20.603 0.729 2.006 12.432 39.937 0.372 3.064 16.362 30.926 0.292 3.333 20 230 93.02/ 0.130 2.203 13.060 42.320 0.121 .. 13.061 10.020 11*14 1ft. feslt C*ntrl Low Hrtlua Hlfh 1.716 0.763 0.415 0.963 0.306 0.634 2.140 14.101 1.240 1.966 7.609 32.034 0.411 0.670 0.060 36.649 0.214 2.770 11.664 30.030 1.039 4.200 17.332 97.996 0.633 6.644 23.663 114.203 0.644 6.330 21.914 165.530 0.256 3.934 30.069 116.1/6 Q.336 .. 24.974 34.614 lbl 18 UbI* 19 11 Ml;. 20 M, 0.436 3 021 16.603 43.210 0.436 2)00 14.018 32.420 1.480 5.065 38.609 97.086 0.931 2.960 17.263 43.612 HONS 0 2 2 3 8 5 s-ai-ss-2 Page 16 TA8LE III Individual Statistical Comparisons Adult Pat Samel as PCB Found - Wat Vfelqht Ehsis 1. Pre Drug 2. I Month 3. 3 Month 4. 4 Month 5. 7 Months 6. 9 Months to 20 Months No significant differences found. Control significantly lower than pre drug control. High level significantly higher than all others. Control significantly higher than 1 month control. High level significantly higher than all others. High level significantly higher than all others. Medium level significantly higher than low and control. Medium level significantly higher than 1 and 3 months medium. All levels differ significantly from one another. Low level significantly higher than 4 months low. Levels remain significantly different except for sharp drop In 16 Month high level data. No further Increase In amount found. PCS Found - Lloid Weight Eesis 1. Pre Drug 2. 1 Month 3. 3 Month 4. 4 Month 5. 7 Months 6. 9 Months 7. 9 Months to 20 Months - No significant differences found. - High level significantly higher than low and control. - High, medium and low significantly different from one another.HIgh and medium significantly higher than control - Same as 3 Month. - High and medium significantly higher than low and control Low significantly higher than control. - All levels significantly different from one another. - High and medium differ significantly from low and control - High significantly higher than medium except 18 and 20 months. - Low significantly higher than control except 20 months. HONS 022386 f Figure 2b S-31-33-2 Control 0 Low 5 Medium 25 High 100 HONS S-81-SS-2 Page 19 Sample Taken 5/24-6/9/78 6/19-8/30/78 7/6-7/31/78 8/8-10/10/78 10/27-12/11/78 TABLE IV Baby Skin Met Weight Basis - Averaaes (PPM) Control Level Fed Low Medlun Hlqh .083 .396 .826 .650 -- .175 2.26 2.42 6.84 1.53 1.45 2.92 16.60 13.84 12.59 1.82 13.80 - Semple Taken 6/19-6/30/78 7/6-7/31/78 8/8-10/10/78 10/27-12/11/78 &bv Fat - wet Weight Basis - Averages (PPM) Level Fed Control Low Medium Hlqh 1.04 0.70 0.61 2.03 10.69 9.04 0.76 8.32 98.17 18.11 108.89 38.90 MQNS 02239 TABLE V PPM PCS Found in Hilt Samples Level Fed Control (0.00) Low (5 PPM) Medlua (25 PPM) High (100 PPM) PC B Found .08 .01 .03 .20 .02 .03 0.22 0.01 0.01 0.(2 0.51 0.46 0.45 0.95 S-81-SS-Z Page 20 HONS 022390 S-8I-SS-Z Page 21 PREPARED BY: Semor Research Specialist Date: t/l7/g / Applied Sciences Coawuter Sciences/ Statistics Group /bjs HONS 022391