Document G6eDQr82L6a3D2qOXz0z0r9en

AtAT ifitt t tttMXBGStJ m Rt iTiMklllH TEH 0532020 96H ORAL AND INHALATION LEAD EXPOSURES IN HUMAN SUBJECTS (IKehoe Balance Experiments) Stanley B. Gross, Ph.D.* Department of Environmental Health University of Cincinnati Current Address: 9036 Jeffery Road, Great Falls, Virginia 22066 > Stanley B. Gross 1979 1 TEH 0532021 DUP050033107 About the Author: Dr. Stanley B. Gross is an environmental tox icologist with over 25 years of experience in research. He has formal training In chemistry, biochemistry, epd medicine from West Virginia University, and completed his postdoctoral training in environmental toxicology under Dr. Emil Pfitzer at the University of Cincinnati Department of En vironmental Health, Kettering Laboratory. Before joining the Department, he served at Battelle Memorial Institute as the Life Scientist on a U.S. Public Health Service contract to design an overview system for evaluating the public health hazards of chemicals in the environment. The resulting two volume report raised questions about mercury pollu tion prior to the discovery of t ne problem of the mer cury contamination of Lake Erie. Dr. Gross joined the Department in 1967 to develop automated Informa Ion systems for tox icology, environmental and occupational health. Some of fhe concepts he published at that time are now be'ng Implemented within the federal govern ment. in 1969, Dr. Gross began measuring the human body burden of lead, a project initiated by Dr. Robert A. Kehoe. His publications emphasize the changes in the concentrations of lead, cadmium, and other trace metals with age and pathological condition in a wide variety of organs In the human. He also developed a method for classifying lead body burdens based on various types of exposure. Dr. Gross is presently a senior level toxicologist with the Hazard Evaluation Division, Office of Pesticide Programs, Environmental Protection Agency in Washington. He has been active in the development of toxicological testing guidelines. He maintains memberships in the Society of Toxicology, the American Industrial Hygiene Association, the American Conference of Governmental industrial Hygienists, the American Chemical Society, Society for Environmental Geochemistry and Health, Sigma Xi, and the American Association for the Advance ment of Science. TEH 0532022 DUP050033108 ACKNOWLEDGEMENTS Support for this investigation was provided in part by Dr. Robert A. Kehoe, Professor Emeritus of the University of Cincinnati, the Ethyl Corporation of Baton Rouge, Louisiana, the Department of En vironmental Health of the University of Cincinnati and the private resources of the Author. The Author is much indebted to Dr. Kehoe for providing these data which represent much of his long and fruitful Career in lead research. He also appreciated Dr. Kehoe's encouragement of independent analysis and companionship during the process. To Mr. Ber nard Sobel of the Ethyl Corporation goes much gratitude for his aid in the computer processing and the statistical analyses. The Author wants to acknowledge the assistance of Ms. Margaret Middendorf, Dr. Jai Yeong Tsay and Ms. Suzan Rasche for their help in the initial phases of the study. Special thanks goes to Ms. Rosaieen Allen for her patient and persistent help in processing the large amount of data which made up the final report. A very special thanks goes to the Author's wife, Ruth, for her understanding and acceptance of the in conveniences of completing this demanding project. Hi TEH 0532023 DUP050033109 ABSTRACT The Kehoe lead balance experiments were carried out from 1937 to 1972 and involved over 21,000 days of measured exposure of lead in humans. Lead balance, lead in the diet, feces, urine and blood were measured under normal conditions and during periods of oral and airborne lead supplementation. A considerable amount of natural variability was seen throughout ail of the experimental periods due primarily to variations in dietary lead. The overall mean blood lead concentration for all subjects was 25 ug/100 gm, with individual control means ranging from 18 to 40 ug/100 gm. The urinary lead concen tration averaged 29 ug/l overall, with individual con trol means ranging from 19 to 45 ug/l. The overall average diet contained 181 ug/day (159 ug/day based on median data); however, the mean dietary lead for the individual control periods decreased from approximately 300 ug/day in 1937 to 100 ug/day in 1970. Fecal lead had an overall mean of 225 ug/day (212 ug/day based on median data) on a per sample basis which exceeded the dietary' lead average due to the fact that most subjects did not defecate on a daily basis. When averaged over the entire control period, fecal lead was 196 ug/day, still in excess of the overall average diet. Lead balance was calculated as dietary lead minus the lead in the feces and urine and did not include an estimate of inhaled lead. Although three subjects were In positive balance during their control periods, the overall average balance was a loss of 32 ug/day ranging from -106 to +25 ug/day for individual control periods. The balance data indicate that an ap preciable amount of lead absorbed from the air was excreted. The ingestion experiments involved dally supplements of 300,1000, 2000 and 3000 ug of lead per day. Except for the subject SW who received the 300 ug supplementation, all subjects experienced Increased lead in the blood, urine, feces and body burden proportional to their ingested lead. For SW, the blood and urine did not increase even though his body lead burden and fecal lead did. On an overall basis, the feces, blood, urine, and balance increased by 0.83 ug/day, 0.017 ug/100 gm, 0.045 ug/day and 0.133 ug/day for each increase of 1 ug of lead in the diet. The Inhalation exposure experiments involved chamber concentrations of 10, 20,75 and 150 ug/m3 for varying exposure times. These chamber ex posures resulted in overall exposure rates ranging from 0.6 to 35.9 ug/m3 when averaged over the en tire exposure period. The influence of the natural variability of the dietary lead permeated all of the in halation experimental periods and tended to override the responses of the blood, urinary and fecal lead at adjusted exposure rates below 10 ug/m3 (below chamber concentrations of 75 ug/m3). On an overall basis, the blood, urine and feces in creased by 0.57 ug/IOOgm, 1.41 ug/day and 1.47 ug/day for each increase of 1 ug/m3 of lead in the air. All subjects who experienced obvious increases in body lead during their exposure periods showed obvious and prompt body lead washout during their post exposure periods. TEH 0532024 DUP050033110 ORAL AND INHALATION EXPOSURES TO LEAD IN HUMAN SUBJECTS (KEHOE BALANCE EXPERIMENTS) INTRODUCTION The Kehoe balance experiments involved human Subjects who were monitored during natural and ex perimental exposures to oral and inhaled lead. The experiments reported here were begun in 1937 as part of an 'intensive effort to investigate the health effects of such exposures. Kehoe began his in vestigations on lead in the summer of 1924 (Ash, 1966 and Campbell, 1966) and published his first paper on the effects of lead in workers in 1925 (Kehoe, 1925). In a series of reports published in 1933 (Kehoe, et al., 1933) he and his co-workers revealed a remarkably early and keen understand ing of the impact of lead in our biosphere: They found that lead was ubiquitous, permeating all aspects of life, primitive or industrialized; that lead was found to be a natural constituent of food and human tissues and that the blood, urine and faces Increased with increases in exposure. These obser vations were made at a time when the use of leaded gasoline in automobiles was limited. Kehoe's expressed purpose in conducting the in gestion experiments (Kehoe, et al, 1940), which also applied to the inhalation experiments, was to Understand further the physiological behavior of lead in the body and to establish quantitative relationships between the body's responses to in creased exposure. This would, in turn, provide data on which to base standards for clinical and hygienic practice. These experiments were also concerned with the quantitative variability of lead in the diet, feces, urine and blood under normal conditions over extended periods of time. The most detailed summary by Kehoe of his work over the years can be found in the Harben Lectures presented in 1960 (Kehoe, 1961a). Several reports (Kehoe, et al., 1939, Kehoe, et al., 1940 and Kehoe, et al., 1943) preceded the Harben Lectures and several publications have been written since (Kehoe, 1961b; Kehoe, 1966; Kehoe, 1969; and Kehoe, 1976). The present report presents many of the raw data and numerous statistical summaries which provide an overview of all of the experiments, including several studies which have not yet been published. The present analysis extensively utilized more recent computer techniques to present this large volume of data. It does not provide the detailed analyses of each experiment which has been characteristic Of Dr. Kehoe's past reports. Dr. Kehoe was preparing such an analysis at the time of this writing. MATERIALS AND METHODS The data from two subjects have been omitted because of early withdrawal from their experiments. Personal data for the other 16 subjects are shown in Table 1. Eleven of the subjects were male Caucasians, five were Negroes, one of whom was female. Their ages ranged from 22 to 55 years with a mean of 34 years. Each subject was hired by the Laboratory for the purpose of serving as an experimental subject. There was a substantial overlap in time of many of the experiments (Figure 1). The early experiments involved dietary supplementations of 1000 (subject MR), 2000 (subject EB), 3000 (subject IF) and 300 (subject SW) micrograms (ug) of lead per day. The first inhalation subject, MOB, was exposed to chamber concentrations of approximately 75 ug/m3 for 7 hours per day, five days per week. MOB and the next 6 subjects (FC, MB, JUS, SB, LD and JOS) were exposed to chamber concentrations of approximate ly 150 ug/m3 for varying daily time periods. The next four subjects (NK, SS, HR and DH were exposed to chamber concentrations of approximately 10 or 20 ug/m3 for varying periods of time. The last subject (PB, the only female) was also exposed to 150 ug/m3. Except for the dose-response data, tabular data for individual subjects have been presented in alphabetical order for ease of reference. Each sub ject participated in one or more control (0), exposure (E) and/or post exposure (P) periods as shown in TEH 0532025 DUP050033111 1 Table 2. The periods are listed alphabetically by the subject's initials and are designated by letters and numbers in this table and throughout the other tables, figures and the text. The "Time on Collection" in Table 2 (Column 3) was considered the duration of each period even though calendar-wise the length of the period included "Off Time" (Column 4), which represented gaps in the data (shown graphically in Figures 3 A to P). These gaps are relatively short and generally do not represent important losses of data. There were several special studies (Table 2) which are not described here in detail, but are presented in order to show as completely as possible the ex posure history of each subject. The CORN exposure period (and postexposure period, PCORN) for MOB was a feeding study. The CNF period for DH was a short inhalation chamber control period in which no lead aerosol was generated. After a long oral ex posure period, MR participated in a variety of dietary manipulations while still receiving daily supplements of 1000 ug of lead. These periods are referred to as E-DC's and P-DC's and were each of a four-week duration in the following sequence: (a) the ad ministration of milk in large volume, (b) large doses of ascorbic acid, (cj deprivation of calcium, (d) deprivation of both dietary calcium and phosphate, (e) the administration of excess calcium, (f) excess phosphate, and (g) excess calcium and phosphate. Subject LD participated in a feeding experiment midway between days 200 and 300 on Figure 3-1 during his control period, but this has not been represented as separate exposure and post ex posure periods. A. Experimental Procedures Since the procedures used in these experiments have already been published on several occasions, they will be presented here only in summary detail. Clinical Evaluations. All of the subjects were given thorough examinations by a physician other than Dr. Kehoe before being accepted as experimental sub jects, Similar examinations were continued throughout the course of the experiments in order to monitor the subjects' health and to assure that none of the subjects experienced any harmful effects due to their exposures to lead. These evaluations Includ ed medical histories, physical examinations, and laboratory analyses. The histories were concerned with general well-being and emphasized gas trointestinal and neuromuscular functions. The physical examinations included information on body weight, temperature, pulse rate, blood pressure, respiratory rate, neurological reflexes, hand strength (measured with a dynamometer), as well as ex aminations of the fundi, teeth and mouth. The laboratory analyses included red and white cell counts, white cell differential counts, hemoglobin and hematocrit determinations and stipple ceil and reticulocyte counts. The urine was examined for color, specific gravity, sugar, pH, protein and formed elements. Porphyrin analyses of urine were per formed for the inhalation subjects only. None of these clinical and laboratory data are presented in this report; however, none of the subjects was found to have experienced any harmful signs or symptoms due to their exposures. Sample Collections and Lead Analyses. Samples of the subjects' diet, feces, urine and blood were collected for lead analyses throughout the oral and the inhalation experiments. The preparation and analyses of the samples were carried out in the Analytical Section of the Laboratory. The samples or sample aliquots used were dried, charred and ashed at 500C using lead free nitric acid as ah ashing aide. The ash was then analyzed using the spectrograph (Kehoe, et.al., 1935) or dissolved in acid and ana lyzed using the colorimetric dithizone procedure of Cholak, at al, (1948). The more recent experiments depended more on the use of the dithizone method, which was shown to be quantitatively comparable to the spectrographic method (Cholak, 1964). Collection containers were constantly carried by each subject tp all of their daily activities. Duplicate samples of all ingested foods and beverages In cluding medicines were collected by each person on a 24-hour basis. These were combined, homoge nized and one third of the homogenate was diluted to 250 ml. Fifty ml of this solution was then used for the lead analyses. Feces were collected for similar daily periods when available. The entire fecal sample was ashed and diluted to 50 or 100 ml depending on the quantity of feces. Five to 10 ml of this solution was used for the lead analyses. The urine was collected without preservatives, mixed thoroughly and 100 ml aliquots were used for lead analyses. Two 10 gram samples of blood at each sampling were drawn on approximately a weekly basis. An entire 10 gram sample was used for the lead analysis. Ingestion Experiments. The ingestion experiments involved daily supplementation of the natural dietary lead in the form of lead acetate solutions, one third of the total being taken with each main meal. The solutions were given to the subjects in standard con tainers and were emptied each time in a uniform manner, so that the slight loss due to incomplete emptying was made as nearly constant as possible. A similar amount of the solution was added tp the composite daily food samples using the same technique. Inhalation Experiments. Subjects received air borne lead supplementation by spending time in one of two Identical respiratory chambers built for this purpose (Kehoe, etal., 1961a). The chambers were cubical rooms, 10 feet in each dimension and were equipped, as office-laboratories where the subjects carried out data handling tasks or simple laboratory 2 TEH 0532026 DUP050033112 procedures; Each room was equipped with two air locks, one for the door and one for the passage of small Items in and out of the chamber, providing for a minimum of disturbance in the lead concentration within the chamber. Table 3 summarizes the chamber conditions used for each inhalation experiment and also includes the data on the subjects' pulmonary analyses. The small particle aerosols, ranging In median count diameters from 0.05 to 0.11 micrometers (urn), were generated by burning tetra-ethyl lead mixed with propane or natural gas to produce lead sesquioxide particles which were introduced into the chamber make-up air To obtain low concentrations, the tetra-ethyl lead was diluted with dodecane. The composition of the particles was confirmed by X-ray diffraction analyses (Cullity, l956)/rom samples taken from inside the chamber. For the preparation of aerosol particles of 0.75 um or greater, a custom-made dust feeder was used in place of the burner to introduce lead sesquioxide at various rates into the chamber make-up air. Lead sesquioxide was deposited inside of a tube of the generator while a rotating blade scraped off particles of the lead oxide. The concentrations in the chamber were controlled by varying the thickness of the oxide deposited on the wall of the tube and by varying the position of the feeder. Daily air samples were ob tained and visually examined to insure that the par ticles were of the correct size range. For particles in the range of 0.75 um or larger, the dust samples were collected on membrane filters and sized under Oil immersion by light field microscopy. For the small particle aerosols, the dust was collected on grids and sized by the electron microscope. Particle sizes were plotted on log-probit graph paper to obtain the quantitative sizings shown in Table 3. The shape of the aerosol particles have been presented in a photograph (Kehoe, 1961a). Chamber samples for lead concentration analyses were collected with electrostatic precipitators operated for periods of approximately two hours for every four hours of exposure. The collected dust was removed from the precipitator tubes by rinsing with nitric acid and analyzing the solutions by the dithizone procedure. The pulmonary deposition measurements were made while the subjects were inside the chamber. The subject breathed through a mask (Kehoe, 1961a) attached through tubing to a three-way "T" tube equipped with two check valves. The subject in haled the chamber aerosol through one valve and exhaled through a second valve through an elec trostatic precipitator into a Douglas gas bag. The amount of the gas in the bag represented the volume of respired air. The amount of lead trapped by the precipitator indicated the amount of iead remaining In the expired air. The difference between the calculated amount of lead inspired and the amount of lead recovered in the precipitator divided by the inspired lead times 100% yielded the percent of lead deposited in the respiratory tract. B. DATA PROCESSING Most of the original data were Contained on com puter tapes and had to be reformatted for the pres ent analyses. The initial data processing was carried out at the Southwestern Ohio Regional Com puter Center at the University of Cincinnati. The sub sequent statistical analyses used in this report were developed at the Litton Computer Services of Reston, Virginia. The Computer plots (Figures 3 A to P) were prepared for the Author by Digital Graphics, Incorporated, Rockville, Maryland using Cal-Comp plotter programs from California Computer Products, Inc., Anaheim, California. Most of the statistical analyses were made using the Biomedical Computer Programs (Dixon, 1970), the Statistical Package for Social Sciences (Nle, et al., 1975) or a desk top computer. A number of source programs were written by the Author and his associates, RESULTS Before considering the results, it should be useful to clarify briefly some of the terminology used in this report. The term "parameter" refers to one or more of the measurements made on each subject, that is the lead in the diet, feces, urine, blood and/or lead balance. The term "balance" refers to "measured balance" and has been used as an indirect measure of true balance, the difference between total body absorption of lead (input) and its excretion (output). Measured balance was calculated by the formula: Balance = Dietary lead - (Fecal lead + Urinary lead) which does not include the contribution to the body made by airborne lead. Chamber concentrations were measured while the subjects were confined to the chambers and a limited number of air samples from a few of the subject's homes were obtained. However, it was not possible to obtain quantitative estimates of non-experimental airborne lead ex posures or to obtain an adequately quantitative in tegrated dose to the lungs during the subject's stay in the chambers. Nevertheless, measured balance provided a useful means for examining changes in the subject's body burden of lead throughout these experiments. Figure 2 shows the types of curves that would be expected for lead levels in the feces, urine end blood during each of the experimental periods. Under equilibrium or steady state conditions of the control period, these parameters should remain constant as shown in Part A of the Figure, When the subjects TEH 0532027 DUP050033113 were exposed to constant additional amounts of lead in the diet or in the air, these parameters should in crease as shown in Part B. There should be two por tions to Part B: an exponential increase which levels off into the second phase, period of stability or "ex posure equilibrium." The differences in the parameters between control levels and the exposure equilibrium levels constitute a "dose-response" due to the exposure. During this time, the soft tissues of the body should become saturated with lead com mensurate with the exposure rate. The opposite changes (Part C) should be expected when the ex perimental lead exposure was stopped. There should be an exponential decrease in each parameter followed by a ``post-exposure equilibrium" in which the lead in the blood, urine and feces should return to control levels. Because of the absence of airborne lead in the balance equation, the changes in balance should simulate the curves for blood, urine and feces only when lead in the diet was increased, but would be ex actly reversed when the subject was exposed to in creased airborne lead. That is, measured balance should decrease during increased airborne lead ex posure periods and increase during post exposure periods. These changes in lead balance would be seen only if airborne lead absorption remained con stant during dietary supplementation and if dietary lead remained constant during airborne lead ex posures. A. Data Plots and Statistical Summaries The raw data for each subject are shown in Figures 3 A to P, and are summarized statistically in Tables 4 and 5. The Figures are presented in order of increasing overall rates of exposure, beginning first with the oral experiments. Individual data points are shown in separate graphs on the ordinate. The individual experimental per iods are separated by the vertical lines. The seasons are represented on the abscissa by January for winter, April for spring, July for summer, and October for fall. Periods of "off time" (Table 2) also shown on the abscissa sometimes overlapped the seasonal designations. When this occurred, preference was given the offtime designations and the seasonal arrow was omitted. The time scale for subjects FC and MOB had to be greatly compressed in order to plot their data on one page. The vertical scales for the parameters were chosen to include at least 99% of the data over the whole experiment. This caused some of the scales of individual parameters to be considerably compressed. The data exceeding the scale limits are presented by the short arrows at the top and bottom of each parameter graph. The curves running through the center of the data points are weekly averages of the plotted data, excluding the off scale data, The curves for the averages help to delineate the trends within the scatter of the data. Selection of Data. Abnormally high data were in cluded in the final data set if there was other cor roborating information. For example, high fecal leads which were associated with high dietary leads were retained. The overall means for each parameter of each experimental period were ob tained and any data which fell outside of 4 SD's of these means were excluded during the final calculations. This process resulted in the exclusion of relatively few data points. All of the remaining data for each of the control periods were used even though there was a con siderable amount of natural fluctuation within the period. Many of the exposure and post-exposure periods did not exhibit any response to experimental manipulation nor did they reach equilibrium con ditions. This was because of natural variability of lead in the diet and/or air or because the experimen tal period was too short. In these cases an arbitrary selection of data which represented equilibrium con ditions was made. It was observed that those ex periments which achieved an equilibrium period did so by 20 weeks or 140 days. This was based on the inspection of weekly data plots (not presented in this report). For experimental periods greater than 240 days, the data from day 140 on were used to calculate equilibrium means. This allowed the use of at least 100 days of data in the calculations. For shorter periods (less than 240 days), the data from the last half of the period were used even though many of the exposure and post-exposure periods were of short duration. The lead distributions in the diet and feces (but not urine and blood) for most of the experimental periods were found to be statistically skewed to the right. Therefore, the statistical data have been presented both in terms of means (Table 4) and in terms of medians and log-means (Table 5). The dose-response data in subsequent tables and figures have been calculated from data means only because the results obtained using medians were not appreciably different from those results based on the means. B. Control Periods The control periods ranged from 31 to 602 days in length. Inspection of the data plots of each individual (Figures 3 A to P) reveals relatively stable levels tor all the parameters during the control periods of sub jects SB, MOB, PB, IF, HR, JOS arid SS. The periods of EB, NK and MB reflected overall increases in several parameters; DH and JUS, overall decreases; and FC, LD, and SW had wide f>uctuations throughout their periods. The control periods of MB, DH and JUS showed fluctuations in the lead of the urine and feces without corresponding changes in diet, suggesting possible changes due to fluc- TEH 0532028 DUP050033114 tuations in airborne lead. The overall arithmetic means (and ranges) for the 16 control periods were 181 ug Pb/day (97-334) for the diet, 225 ug Pb/sample (110-425) for the feces, 29 ug Pb/day (19-45) for the urine, 25 ug Pb/100 gm (18-40) for the blood and -32 ug Pb/day (-106 to +25) for lead balance. The corresponding data based on medians (and log means) were 159 (162) ug/ day, 212 (205) ug/sample 33 (27) ug/day, 25 (24) ug/100 grh and -32 ug/day, for the diet, feces, urine, blood and balance, respectively. The control period means are presented graphically by year in Figures 4 A to C. Besides a considerable amount of variabili ty between subjects, there was an overall decrease with time which was statistically significant for the diet (r = -0.86 P<0.01) and blood (r = -0.63, P<0.01). Fecal Lead. Fecal lead in Tables 4 and 5 is ex pressed on a per sample basis rather than on the average dally fecal excretion. Each sample included all evacuations, if any, over a 24-hour period. For most subjects, the fecal lead excreted on a per sam ple basis was greater than the amount of lead in the daily diet Since most of the subjects did not defecate on a daily basis, their evacuations included unabsorbed lead from more than one day's diet (assuming an insignificant amount of lead to have been secreted Into the intestinal tract). In Table 6, the fecal lead has been converted to a per day basis (column 3) by multiplying the average for fecal lead on a per sample basis by the subject's evacuation rate (column 2, Table 6) over his or her experimental period. For most subjects the daily average was sub stantially lower than the per sample average. This adjustment resulted in an overall control period average for fecal lead of 196 ug/day with a range of 102 to 425 ug/day. Based on median data, the overall average was 164 ug/day. Expressed on a per day basis, most of the fecal leads still exceeded the daily intake of the diet (column 4). The overall mean percent of diet was 109% (105% based on median data), with a range of 83 to 177%. Urinary Lead. Most of the literature presents urinary lead on a concentration basis. Table 7 has been used to compare daily urinary lead concen trations to 24 hour urinary lead excretion. The con centration data was derived from the same daily Samples used in Tables 4 and 5. The control periods had an overall mean of 25 ug/liter which ranged from 16 to 37 ug/liter of urine. The overall average ratio of the concentration data to the 24 hour data was 0.93; however, individual's mean ratios ranged from 0.58 to 1.15. C. Experimental and Parameter Variability Coefficients of variability (CV's) for each parameter are presented in Table 8 for each control period by the year of the experiment. The cor responding SD's are presented graphically in Figures 5 A to C. Blood exhibited the least amount of variation with an average CV of 22%. This was followed by the urine with 34%, the dietwith 57%, the feces with 73% and balance, 1526%. The CV's for balance were large because the means for balance used in the denominator in calculating the CV's were so near to zero (Table 4). The variability of the diet, feces and balance for LD's control period was inor dinately high because of several episodes of ex cessive lead ingestion (see Figure 3 I). The variability of the lead parameters was relative ly stable over the years of the experiments; however, there were overall decreases as seen in Figures $ A to C. The CV's for blood tended to decrease significantly (r = -0.53, P<0.05) with time. The decrease in the SD for blood seen in Figure 5 C was in excess of the decrease in the control period means (Figure 4 C). The decrease in dietary lead variability (Figure 5 B) was also associated with a decrease in mean dietary lead (Figure 4 B), However, the decrease did not attain statistical significance (r = 0,23, P>0.05). Chamber conditions (Table 9) were also generally stable over the years of the Inhalation experiments. The overall CV's were impressively small, but in dividual variability of the chamber conditions in some cases was 2-3 times that of the overall average. Daily exposure times spent in the chamber were generally constant throughout the experimental periods; however, in some instances these hours varied considerably (column 4, Table 9). There were five different particle sized aerosols used in the chamber exposures. An inspection of the CV's for the deposition data grouped by particle size did not indicate any analytical variation between the groups. However, when the percents of deposition recorded for the 38 inhalation periods which used 0.05 um aerosols were arranged according to the year of the experiment, there was a tendency for the rate of deposition to increase (r = 0,37, p<0,01), The regression equation through these data suggested that the deposition average for 1951 was 30,2% and in 1969 it was 48.0%, an increase of 63% over the years. Correlations Between Diet, Feces, Urine, Bipod and Balance. The correlations between several of the parameters during the control periods in Table 10 are arranged for each subject by year. Under control conditions none of the parameters had high inter-parameter correlations, and therefore, were not predictive of any other parameters even though several of the coefficients were statistically signifi cant. Thus, neither blood nor urine could be used to predict changes in diet or balance. The correlation coefficients between the parameters tor the data of the combined experimental and post experimental periods are arranged in Table 11 for each subject by increasing doses of lead. By comparison to the cor- TEH 0532029 DUP050033115 relations for the control period data, there was a larger number of higher and more significant interparameter correlations. However, none of these parameters could be used to predict any of the other parameters. 0. Oral Supplementation Experiments. Oral Exposure Responses. The data points for the individual oral exposures are shown in Figures 3 A to D. Definite exposure responses were obvious in all of the parameters for the upper three dosage levels (MR, EB and IF). The changes were Seen in the diet, feces and balance for SW; however, his blood and urine did not show any responses. Equilibrium ex posure conditions were achieved for MR and EB but not for IF. IF'S exposure period was terminated before equilibrium could be achieved. The con siderable amount of fluctuation in urinary lead seen for the exposure periods of MR and EB was probably due to the concurrent fluctuations in dietary lead which is difficult to see in the figures because of the scale compression. Both MR and EB had long ex posure periods during which time their blood leads increased to equilibrium averages of 53 and 60 ug/100 gm, respectively, with a few individual values exceeding .80 ug/100 gm. Their daily urinary leads increased to means of 79 arid 117 ug/day, respec tively, with most of the values remaining below 160 ug for MR and 240 ug for EB. The dose-responses to the oral supplementation shown in Table 12 are plotted in Figure 6. The daily lead in feces and lead balance were linear for all 4 subjects. The responses of lead in blood and urine were linear for the intermediate exposure rates (1000 and 2000 ug/day). The final blood and urine lead levels of IF were low because his exposure was terminated prior to achieving equilibrium conditions. Although fecal and dietary lead and lead balance were changed, no responses of the blood and urine were seen for SW even though he received dietary supplementation of 300 ug/day. The solid lines in Figure 6 represent the overall regressions of each parameter with increasing oral lead supplementations. The lines have been drawn through the origin and are placed so as to give the two intermediate exposure levels the most influence. The calculated oral response data in the top of Table 15 are based on these regression lines. The slopes of the lines represent increases of 0.017 ug/100 gm for blood, 0.045 ug/day for urine, 0.83 ug/day for feces and 0.133 ug/day for balance with each in crease of 1 ug of Pb In the diet. Oral Post-Exposure Responses. Post exposure responses for the oral subjects are summarized in Table 13. Obvious washout responses (exponential decreases) were seen in the post exposure data of MR, EB and IF. There were suggestions of decreases in the blood and urine along with the diet and feces for SW even though SW showed no substantial in creases in his blood and urinary lead during ex posure. All of the individuals reverted to negative balance during their post exposure periods. The urine and blood lead for MR, EB and IF, even with long post exposure times, did not return to pre exposure control levels. E. Inhalation Supplementation Experiments Inhalation Exposure Responses. Individual's data points for each of twelve inhalation exposure sub jects are found in Figures 3 E to P. The exposure periods of NK, SS, HR, DH, LD and JOS were of such short duration that exposure equilibrium conditions could not be achieved. The responses that were observed for subjects NK, SS, HR and DH were associated with increases and decreases In dietary lead rather than increasing exposure to airborne lead. Parameter responses due to the chamber ex posures were not visibly apparent until exposure rates of 75 ug/m3 or more were used. Mean blood leads for most of the exposure experiments re mained below 40 ug/100 gm and exceeded this level during only 3 exposure periods (LD-E4, and JOS-E3 and E4). The dose-responses to the inhalation exposures which are summarized in the bottom half of Table 12 and in Figures 7 A to E are presented in terms of adjusted exposure rates. Particle size information has also been included in the dose-response data in Figures 7 A-D. The adjusted rates represent the exposures averaged over the whole experimental period and were obtained using the following formula: Adjusted Inhalation Rate = -Sje-t where c represents each daily chamber Concentra tion in ug/m3, t represents the time in hours fpr each day, summed for each exposure (Set) divided by the total time of the experimental period T, In hours. T was obtained by multiplying the total number of Calendar days (experimental time plus weekends and off times) by 24 hours. Expressing the responses for each inhalation experiment on the basis of the adjusted exposure rates allowed for the comparisons between experiments which used different concentrations and exposure times. Blood, urine, and fecal lead increased and lead balance decreased statistically (Table 14) over the whole range of the exposures; however, the responses in the lower ranges (less than 10 ug/m3) were related primarily to changes in dietary lead. This relationship was demonstrated statistically (Table 14) and by the fact that balance for the lower exposure rates were positive (Figure 7 A). Diet also had its influence at the higher exposure rates, along with particle size which had a major influence. Blood TEH 0532030 mb DUP050033116 (Figure 7 E) and urine (Figure 7 D) levels for the ex periments which used the larger particles (MOB, JUS, MB, PB and FC) were found in the lower por tions of the response data distribution. The dotted lines In Figures 7 A to E were used to join the data points obtained from the same in dividual. The linear regression lines are based on ail of the response data; however, the curves were forced through the origin using the regression analysis of Ryan et al., (1976) as provided by Mr. Bernard Sobel (Ethyl Corporation). The calculated response data in Table 15 were derived from these regression lines in which blood lead increased by 0.57 ug/100 gm, urine increased 1.41 ug/day, feces increased 1.47 ug/day and balance decreased 3.32. ug/day for each 1 ug/m3 increase in airborne lead. Inhalation PosttExposure Responses. Subject HR did not participate in a post exposure period. Ob vious experimental washout curves for blood and urine were seen In the post-exposure periods of LD, JOS, MOB, SB, MB, FC and JUS. Many post ex posure periods were too short to show any washout: NK-P1, SS-P1, 2 and 3, PB and FC-P1. The absence of washout curves for NK, SS and DH was probably due to the fact that there were no obvious responses to the exposures of these subjects. From the post exposure summary in Table 13 it can be seen that the final levels of lead in blood and urine were for the most part dependent on changes In dietary lead. Two subjects, NK and .SS, showed increases In blood, urine and lead balance during their post ex posure periods due to increased dietary lead. Seven of the subjects who had the higher airborne ex posure rates (From JOS to MOB in Table 13) were in more negative balance than during their control periods, indicating that they were still losing lead from their bodies at the end of the post exposure periods. The magnitude of washout (rate of negative balance) was not proportional to their exposure rates. DISCUSSION These experiments, carried out over a 34 year period, involved 102 separate experimental periods and over 21,000 days of measured exposure to lead. A considerable amount of time was required to collect, organize, analyze, verify and present this large amount of data. The original data used to derive the results presented have been put on com puter tapes and will be made available to qualified researchers through the Department of Environmen tal Health at the University of Cincinnati or through Ethyl Corporation, Baton F.ouge, Louisiana for the cost of duplicating the con* puter tapes. Experimental Control. These studies have had the advantage of being under the control of the same in vestigators (Kehoe, Cholak, Schafer and Yeager) over the duration of the experiments. Thus, good ex perimental control was maintained over the years. There was, however, some improvement in precision of the lead analyses as can be seen in the reduction of the SD's shown in Figures 6 A to C. This can also be seen in the distribution of blood data in Figures 3 A to P in which the differences between adjacent data were smaller in the more recent experiments. Blood lead had the least amount of variability. The larger variability of lead in the diet, feces and urine, by comparison to blood, was in part artificial. Each lead determination had a precision of plus or minus 0.2 to 0,5 ug per Pb determination. This precision applied to each 10 ml blood sample which was used in its en tirety. However, this analytical variability was amplified 5 to 20 times when calculating the amount of lead in the 24 hour samples of the diet, feces and urine from the respective aliquots used in the lead analyses. Such variability did not affect the reliability of the data averages which usually involved substan tial numbers of observations. The natural variability of the data produced troublesome fluctuations at times throughout these experiments. Every effort was made to retain as much of the data as possible and to select data without introducing Investigator bias. This was achieved by using 4 SD's to exclude potentially con taminated samples and by the selection of equilibrium data based on objective criteria applied to all of the exposure and post-exposure periods. A. Normal Exposures to Lead The control periods provided one of the best prac tical estimates of normal exposures to lead. Carrying collection containers to all personal activities no doubt altered somewhat the subject's normal patterns of behavior, The striking variability of lead in each of the measured parameters was im pressively large at times but was so consistent from individual to individual and within the same in dividual that such variability cannot be considered abnormal. The time of year was shown for the data on each of the plots (Figure 3 A to P) in an effort to identify possible fluctuations which could be associated with seasonal changes. Seasonal changes in the concentrations of lead in the air have been reported (Tepper and Levin, 1972) but no seasonal effects were observed in the Kehoe data. The lack of seasonal influences due to fluctuations in the ambient air concentrations is not surprising since the responses to such fluctuations would be obscured by the natural variability of the diet, which also showed no seasonal trends. Dietary Lead. Estimates of lead in the subject's diet were based on the analyses of duplicate diets and duplicate samples of other ingested items (such TEH 0532031 DUP050033117 as medicines). Since the duplicates were not measured exactly, over- and underestimated por tions were possible. Requiring each participant to quantitatively measure each food item would have distorted the normal dietary patterns. Most likely any excessively large samples were counterbalanced by correspondingly small samples. The range of natural dietary lead was con siderable. It was not uncommon for the daily dietary lead to be as low as 30 ug and as high as 500 ug. Temporary fluctuations such as these had no effect on the levels of lead in the blood and in the urine. Much of the literature suggests that the average diet contains approximately 300 ug Pb/day which was often based on past reports by Kehoe (1961a). With the inclusion of the more recent experiments, the overall average of the Kehoe studies has been reduced to 180 ug/day (or 159 ug/day based on me dian data which are more representative of the nor mal diet). The decrease in dietary lead (Figure 4 B) suggests that normal diet in 1970 was more on the order of 100 ug/day (87 ug/day based on medians). The decrease from the 300 ug/day in 1935 was con sidered by Kehoe (1961a) to be due primarily to decreased contamination of food during its process ing and handling. There is a limited number of published studies which involve measuring lead in actual dietary samples. However, none of these are comparable to the present study in the number of individuals and the number of days measured. Thompson (1971) sampled 5 individuals for 12 to 28 days and found mean intakes of 274 ug/day (range of 237-306 ug/day). Couiston et al, (1972) measured one day samples from 17 individuals in an Institutional setting and obtained a 113 ug/day average (range 74-215). A number of other studies (WHO, 1977) have found comparable estimates of daily lead intake based on lead concentrations In various Individual foods. Fecal Lead. Fecal lead on a per sample basis varied more widely than did the daily ingested lead and was considerably higher than the lead in the diet. The correlation between fecal and dietary lead was poor (Table 10). This phenomenon was probably due in major part to the fact that most sub jects did not defecate on a daily basis and thus the fecal lead represented unabsorbed dietary lead from more than one day's dietary intake. This assumes that biliary secretion of lead is quite limited (N.A.S. 1972). The practice of using single fecal samples, therefore, cannot be used reliably to predict dietary lead. Converting fecal lead to an average dally basis brought the fecal lead more In line with dietary lead (shown graphically in Figure 4 B); however, the con version resulted in an overall ratio of fecal lead to dietary lead of 1.09 which suggested that fecal lead amounted to 109% of the lead found In the diet. This percentage varied considerably from individual to individual (Table 6). These results are at variance with the notion that fecal lead represents 90 to 95% of the lead in the diet (Kehoe, 1961a: NA$, 1972; WHO, 1977). However, five of the subjects (LD, DH, NK, MR, SS) had very high fecal leads whiph aver aged 149% (ranging from 135 to 177%) of the diet while the other 11 subjects excreted an average of 92% (ranging from 83-104%) of the dietary lead in the feces. Under the increased dietary lead load of the ingestion experiments the percent of the dietary lead found in the feces decreased reflecting an in creased absorption rate. Thompson (1971) found fecal lead to average 240 ug/day (range of 207-271) in 5 subjects on collection from 12 to 28 days. The Kehoe subjects averaged 196 ug/day over their control periods. Tepper and Levin (1972) reported median fecal leads of 85 to 150 ug/day based on 10 day collections from groups of 20 subjects from 8 cities over the U.S. The Tepper and Levin data are somewhat lower than the median fecal data shown in Table 5. Urinary Lead. Like most of the other parameters daily urinary excretion of lead varied considerably from day to day (Figure 3 A to P) and from individual to individual (Table 8). Thompson (1971) reported the average urinary lead to be 16 to 30 ug/day which compared well with the 19-45 ug/day in these studies. Although there are numerous references to acceptable levels of urinary lead excretion (Lane et al. 1968, NIOSH, 1972, HAS, 1972), there are very few published reports on urinary lead excretion per se in adults under normal conditions besides the data already published by Kehoe. Most literature reports involved exposed populations, chelation studies or analyses of other indicators of exposure such as urinary delta-aminolevulinic acid. The lead in the urine averaged 16% of the diet with a range of 9 to 47%, The 47% (of LD) was the only such value with ail of the other values ranging from 9 to 22%. On an overall basis, daily urinary excretion (29 ug/day) approximated the 24 hour urinary lead con centration (25 ug/l); however, the individual ratios of the concentration to the daily urinary output were quite variable ranging from 0.3 to as much as 12 times. Based on the means and standard deviations, 95 to 99% of the control lead concentrations (Table 6) were well below the 80 ug/l cited as normal (Lane et al. 1968) and were in good agreement with the data reported in the "Three City Study" (USPHS, 1965).' Blood Lead. Except for 2 early subjects (MR and SW), the control average blood concentrations were at 30 ug/100 gm of blood or less. Blood lead had the least amount of variability although individual data points (Figures 3 A to P) varied considerably at times. Such variability was probably analytical in nature. Keppler (1970) reported on a study by 66 8 TEH 0532032 DUP050033118 laboratories which analyzed blood from the same sample. Eliminating the extreme upper 10% and lower 10% still left a range of 14-53 ug/IOOg. Lerner (1975) reported on 3$ samples taken from one volunteer in a single collection. The samples were submitted coded to the Kettering Laboratory. Values ranged from 12 to 42 ug/IOOg. Rejecting the 42 as an outlier, the range was 12 to 28 ug/IOOg with a stan dard deviation of 3.9. Balance, Balance as measured here was extreme ly variable. This was due Iri part to the lack of daijy defecation and to the natural variability of lead in the diet and the feces. The balance data for several of the Individuals were somewhat unexpected (high or low) based on other studies presented in the literature and on the results obtained from these ex periments as a whole. The -32 ug/day overall balance would fepresent background lead of ap proximately 10 ug/mJ (Table 15), which is over 5 times higher than what would be expected (Table 17, NAS, 1972). Five of the same subjects who had high fecal leads (LD, DH, NK, MR and SS) con tributed very substantially to the overall negative balance average with balances ranging from -48 to -106 ug/day. The other eight subjects had balances which ranged from -3 to -31 ug/day. Rabinowitz (1974) using stable isotopes techniques in human balance studies reported that air contributed only 17 ug/day to the body. It is possible that some of the Kehoe subjects were exposed to relatively high air borne lead outside of the Laboratory, they had had high past exposures, or they were receiving less lead in their control diets than they experienced previously. On the other extreme are the three subjects who were in positive balance, with one of these (FC) gain ing 21 ug/day and another (HR), 25 ug/day. Balance becomes positive only when the diet increases. Ac cording to the data in Table 15, an increase of 200 ug/day would be necessary to Increase balance by 27 ug/day. Both FC's and HR's dietary control lead were low (238 and 156 ug/day, respectively). An average increase of 200 ug/day in dietary lead in these subjects over their previous diets was not like ly. However, the control diets for both of these sub jects were higher than any of their other experimen tal periods. Although the measured control balance data may not adequately represent the true balance in these subjects, the spread of the control data suggests that the subjects' exposure prior to their control periods probably influenced the balance results dur ing their control periods. The fact that fecal lead generally represented more than that found in the diet and that balance was generally negative suggests that most (if not all) of the lead absorbed from diet or the air was excreted from the body and that under these normal exposure rates (for Cincin nati) these subjects were probably in lead balance with their environment. This observation is consis tent with the findings based on tissue fead concen trations from humans from the Cincinnati area as previously reported by this author (Gross, et al, 1975). B. Oral Supplementation Experiments There was only one subject for each of the 4 levels used in these experiments. Except for SW, the levels of oral supplementation were considerably in excess of the normal diets. The responses of balance and fecal lead were surprisingly linear for all four sub jects (Figure 6). On the other hand, blood and urinary responses were linear only for MR and EB, both of whom achieved equilibrium conditions dur ing the exposure periods. The decreased responses of blood and urine for IF were probably due to the fact that his experiment was terminated after 113 days before equilibrium conditions could be achieved. Doubling the dietary intake of lead as for SW, did not effect his blood or urinary levels, even though his body was in a definite positive balance state of 59 ug/day (Table 12). Blood lead concentrations usually reflect increases and decreases in the concen trations of lead in soft tissues but not necessarily those in the bones (Gross, 1976). Since the blood lead of SW did not reflect the increase in body lead, this suggests that the absorbed lead was taken up by his bones rather than by his soft tissues. All subjects during the ingestion experiments were in strong positive balance due to the retention of dietary lead. Fecal lead dropped from 109% to 83% of the dietary lead and urinary lead dropped from 18% to 4.5% of the diet. The post exposure periods of MR, EB and IF were all accompanied by strong washout periods in which the blood and urinary lead levels decreased with time and each subject went into strong negative balance. Post exposure parameter levels were not quite com parable to pre-exposure levels because the post exposure dietary lead levels were not the same (Table 13). The positive balance In the postexposure period for MR cannot be satisfactorily ex plained. Overall Responses to Increased Dietary Intake. Assuming the data from Figure 6 are generally rep resentative of the magnitude of the changes in the various parameters with increases in dietary lead, blood lead would remain in the normal range (40 ug/100 gm or less) up to dietary levels of ap proximately 1000 ug/day over an extended period of time. This represents 3 to 10 times the amount of lead normally found in an average adult diet. Since lead acetate used to supplement the diets of these subjects is a soluble form of lead, it is possible that this form of lead may have been more readily ab sorbed than the lead occurring naturally in the diet. These curves probably do not apply to children since they apparently can absorb more of their dietary TEH 0532033 DUP050033119 lead than adults. Other factors such as dietary reasonable overall response curved (Figures 7 A, calcium, iron, zinc and vitamin D which can modify B, C & E). the absorption rates from the intestinal tract (WHO, Particle Size. Particle size affects the deposition 1977), may also effect the rate of absorption of and therefore the absorption and retention of lead lead, C. Inhalation Supplementation Experiments from the lungs. According to the ICRP lung model (Task Group on Lung Dynamics, 1973) small size particles with mass median equivalent diameters Exposure Bate Selection. Only three chamber (MMED) of. 1.0 micrometer (urn) or less are concentrations (10, 20 and 150 ug/m3, except for deposited in the lower respiratory tract (alveoli and MOB-E1) and a wide range of exposure times, rang small bronchioles) and the larger particles (5 - 10 ing from 3 hours every other day to 13 hours a day, 6 urn) are deposited in the upper respiratory tract (of days per week were used to supplement the sub the naso-pharynx, trachea and bronchial tree). Par jects airborne lead exposures. The exposure rate of ticles deposited in the upper pulmonary tract can be FC 1 was excluded from any analyses because this removed from the lung by mucociliary action and exposure was for only 9 days. The chamber concen subsequently swallowed. trations of 150 ug/m3 were chosen to simulate the Thirty-eight of the inhalation exposures involved acceptable work place concentrations. The aerosols with median count diameters of 0-05 um Threshold Lirrift Value at that time of these ex while 5 subjects were exposed to larger particles: periments was 150 ug/m3 for the 40 hour week 0.11 um (PB), 0.75 um (MB), 0.9 urn (FC-E3) and 1.20 (ACGIH, 1971) which, when converted to the ad justed rates, corresponded to 35.7 ug/m3. The lower urn (MOB-E2 and JUS). According to the Panel on Airborne Lead (NAS, 1972), median count diameters of end of the exposure range simulated community ex 0.05 and 0.9 um correspond to MMED of 0 26 and posures which can be expected to vary depending 2.9 um and atmospheric lead particles range from on whether the area is urban or rural, the traffic den 0.15 to 0.3 um MMED. All of the experiments in the sity and the time of day, the weather conditions low exposure range (less than 10 ug/m3) involved (inversions vs. good air circulation) and on the prox particles of count diameters of 0.05. Above TO imity to industries which emit lead fumes (NAS, ug/m3), all particle sizes were represented and the 1972) . influence of size was apparent. All of the blood and Factors Affecting Dietary Lead Responses. urine dose responses of the larger particles were in Dietary Lead. The Influence of the natural the lower portions of the distributions of Figures 7 D variability of dietary lead was unexpected. In reports and E. Also fecal lead (Figure 7 B) tended to increase from the literature, dietary lead was measured when the larger particle sizes were used even in the directly during the inhalation studies by Rabinowitz face of decreased dietary lead (Figure 7 C). et al. (1974) and Coulston and Goldberg (1972 and Pulmonary Deposition. Deposition varied con 1973) and indirectly by fecal lead analyses by siderably between individuals ranging from 30% (SS Tepper and Levin (1972). However, none of these in and JOS) to about 70% (HR) and was also quite vestigators examined the influence of potential variable for measurements on the same individual changes of the diet as it might have affected airborne (Table 3), An examination of the deposition lead responses. measurements for only those experiments which Dietary lead intake during the control periods was used only particles of 0.05 um showed that there was also important since elevated dietary lead would an increase in measured deposition of 63%. This tend to dampen and lower dietary intake and would may have been due to modifications of the tech tend to exaggerate the exposure responses. In niques used in measuring deposition. There was no several cases, the control period diets were ap apparent association between deposition and parti parently not representative when compared to the cle size but there was an association between diets of the exposure and post-exposure periods: SS deposition and ventilation rate. As ventilation rates had an unusually low (146 ug/day) control compared decreased from 18.5 )/min (SB) to 6.52 l/min (HR), to an overall average for all of his dietary lead levels deposition rates increased from 34% to 64.2%, ]j of 201 ug/day which ranged from 137 to 460; the respectively. This phenomena was also observed by I[ ij control diet for MOB was 211 ug/day compared to the lower overall average of 153; and FC had a high Mehani (1966) and Muir and Davis (1967) and Hatch and Gross (1964) and was explained on the basis of control of 236 ug/day compared to an overall an increase in the number of respirations per minute average of 171. There was no way to determine what which increased the influence of the dead space of was an appropriate control period level nor to adjust the respiratory tract. the data for the influence of changes in the diet. Overall Responses to Increased Airborne Lead. Since there was a relatively large number of The linear regression fines drawn in Figures 7 A, different inhalation exposure periods (44 in ali), B, D & E suggest the magnitude of the overall hopefully any elevated control diets were balanced responses of lead balance and lead in the urine, out by any low diets (Figure 7 C) to provide a fecea and blood to increasing rates of airborne lead 10 TEH 0532034 DUP050033120 exposure. None of these parameters was statistical ly predictive of the exposure rates. A number of studies have attempted to relate blood lead to airborne lead exposure. Using a relatively large population sample, Tepper and Levin (1972) found no correlation between normal blood lead and ambient air lead levels. Goldsmith and Hex- ter (1967) and Azar et al. (1973) report logarithmic in creases in blood lead concentrations of 1.3 and 1.0 ug/100ml in blood per 1 ug/m3 increases in air lead. These studies suffer from the fact that the air level measurements could not be directly related to the in dividuals from whom blood lead concentrations were obtained. It is also probable that the correlation of the raw data (as opposed to the log-log data) would not be statistically related to exposure. Coulston et al. (1972, 1973) studied exposures of 40 individuals but difif express their final results on the basis of blood changes with exposure. Their control blood concentrations ranged from 12-29 ug/100 ml and increased to averages of 27 ug/100 ml for daily exposures of 3.2 ug/m3 and to 35 ug/100 ml for ex posures of 10,9 ug/m3. The regression curve in Figure 7 E suggests that blood lead increased by only 0,57 ug/100 gm which is considerably lower than the rates presented by Goldsmith and Hexter and Azar. This curve was calculated by giving equal weight to all of the data points; however, the line was statistically forced through the origin which greatly reduced the in fluence of the responses of the low exposure rates. Assuming this curve to be representative of the type of responses which might apply to the population at large, normal blood lead concentrations (40 ug/100 gm or less) would be maintained at ambient air con centrations to 26 ug/m3. This is over 12 times the air levels sustained in most cities. Based on a 40 hour work week, this is equivalent to 110 ug/m3. Besides those discussed above, there are a number of other factors which need to be con sidered in applying these data to the population at large. Lead sesquioxide was used throughout these experiments. Lead is found in various chemical forms in the atmosphere as halides, mixed oxides and halides, carbonates, etc. (NAS, 1972; Ter Haar, 1975). Different chemical species of lead might have different solubilities in tissue fluids and therefore potentially different absorption characteristics. Par ticle charge, shape and other physical factors can also influence the deposition, and therefore reten tion and absorption of lead by the lung. D. Significance The experiments reported here represent the most extensive and intensive investigation of the physiology of lead in humans ever undertaken. No other laboratory has engaged in research on the effect of lead on humans to the extent of that of Dr. Kehoe and his colleagues. Dr. Kehoe has had more personal experience in the investigation of lead un der a wide variety of normal environmental con ditions, during many different industrial operations and in the evaluation of many cases of lead poison ing in children as well as in adults. His investigations have served as standard references for almost 5D years. The results of the present analysis will further substantiate the importance of lead research from the Kettering Laboratory. These experiments provide the best practical es timates of normal exposures to lead. The results emphasize the Importance of the natural background variability both in evaluating humans in their natural environments and during exposures to specific sources of lead. These data suggest humans tend to be in balance with their environment and that adults can tolerate rather high exposures to lead without developing frank intoxication. An individual can absorb large quantities of lead for short periods of time without showing this in the urine or blood. After termination of increased exposure, con siderable amounts of previously absorbed lead can be readily excreted from the soft tissues (as reflected by balance and decreases in blood lead concentrations) and, on a more prolonged basis, ex creted from the bones (as reflected by the continued excessive negative balance). Each of the individual experiments examined here provided considerably more information than could be presented in this brief summary. Especially Im portant would be an effort to develop mathematical models which could be used to describe the kinetics of lead movement in and out of the body; and hopefully, provide the ability to quantify the con tributions of lead by each of the absorption routes to the blood, urine and to body burden of lead. : REFERENCES ACGIH, (1971). Documentation of the Threshold Limit Values, 3d ed. pp. 143-145, American Conference of Governmental Industrial Hygienists. Cincinnati, Ohio. Ash, W. (1966), Robert Arthur Kehoe, M.D. Arch. Environ. 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Particle size distribution of metal components in ur ban air. Environ. Sci. technol. 2, 288-290. Lerner, S. (1975). Blood lead analyses - precision and stability. J. Occup. Med. 17, 153-154. Mehani, S. (1966), Lead retention by the lungs of lead-exposed workers. Ann. Occup. Hyg. 9,165-171. Muir, D.C.F. and Davies, C.N. (1967). The deposi tion of 0.5 u diameter aerosols in the lungs of man. Ann. Occup. Hyg. 10, 161-174. TEH 0532036 DUP050033122 N.A.S. (1972). Lead. Airborne Lead in Perspective. Committee on Biological Effects of Atmospheric Pollutants. National Research Council, National Academy of Science, Washington, D.C. Nie, N.H., Hall, C.W., Jenkins, J.G., Strelnbrenner, K., and Bent, D.H. (1975). Statistical Package tor Social Sciences (SPSS). 2nd Ed., McGraw Hill, New York. N.I.O.S.H. (1972). Criteria fora Recommended Stan dard. Occupational Exposure to Inorganic Lead. National Institute for Occupational Safety and Health, Cincinnati, Ohio. Nozak!, K, (1966). Method of studies on inhaled par ticles in human respiratory system and retention of lead fume, Ind. health 4, 118-128. Rabinowitz, M., Wetherill, 3.W. and Kopple, J.D. (1974). Studies of human lead metabolism by use of stable isotope tracers. Envlr,, Health Perspectives, 7, 145-153. Ryan, T.A., Joiner, B.L. and Ryan, B.F. (1976). Chapter 9. Correlation and Regression, pp. 148-194. In Mintab Student Handbook. Duxbury Press, North Scituate, Massachusetts. Task Group on Lung Dynamics. (1966)? Deposition and retention models. Health Physics 12, 173-208. Tepper. L.B. and Levin, L.S. (1972). A Survey of Air and Population Lead Levels in Selected American Communities. Dept, of Environ, Health, University of Cincinnati, Ohio. Ter Haar, G. (1975). Environmental Lead and Its Effect on Man: Sources and Pathways. Ethyl Cor poration, Ferndale, Michigan. Thompson, J.A. (1971). Balance between intake and output of lead in normal individuals. Brit J. Ind. Med. 28, 189-194. Tomashefski, J.F. and Mitchell, R.I. (1965). Sym posium on Environmental Lead Contamination. Battelle Memorial Institute, Columbus, Ohio. U.S. Public Health Service. (1965). Survey of lead in the Atmosphere of Three Urban Communities. Divi sion of Air Pollution, U.S. Public Health Service, Cin cinnati, Ohio. W.H.O., (1977). Criteria for Lead- Task Group On En vironmental Health, World Health Organization, Geneva, Switzerland. mm TEH 0532037 DUP050033123 Table 1 Personal Data on Subjects3 Subject Age (yrs) Sex Race Previous Occupation EB 48 M N Post Office MB 42 M N Qhauffeur/Butler MOB 28 M N Student PB 37 F N Lab Assistant SB 25 M C Valve Company FC 29 M C Farmer LD 33 M C Merchant IF 34 MC DH 23 M C Student NK 50 M C Wood Worker HR .22 M N Student * MR 30 M C Student JOS 32 M C Welder JUS 55 M c Merchant SS 24 M e Student SW 30 M c Garage Owner aPersonal communication from Ms. Jan Stewart of the Department of Environmental Health, University of Cincinnati. U TEH 0532038 DUP050033124 Subject EB MB MOBe PB SB FC LD IF DH Table 2 Experimental Periods Arranged Alphabetically By Subjects' Initials 0 Period Time on^ Collection (days) Offc Time (days) Rate of ^ Exposure C 56 646 PI 908 P2 84 2000.0 ug/day c 148 29 E 333 P 702 48 29.4ug/m C # El PI Corn P Corn E2 P2 244 9 628 50 866 87 21 182 2 384 431 37 22.4 ug/m3 28.4 ug/m3 C 232 E 237 P 28 28.4 ug/m3 C 384 504 P 378 27,4 ug/m3 C 536 85 El 9 64.8 ug/m3 PI 47 E2 616 30,6 ug/m3 P2 535 66 E3 364 30.1 ug/m3 P3 499 75 C 602 36 El 112 E2 115 E3 109 E4 112 P 196 9.3 ug/m3 19.7 ug/m3 27.1 ug/m3 35.9 ug/m3 C 478 48 E 113 3000.0 ug/day P 166 C CNE El E2 E3 E4 P 224 28 112 112 112 112 84 5.6 ug/m3 7.3 ug/m3 7,6 ug/m3 8.8 ug/m3 TEH 0532039 DUP050033125 Subject NK HR MR JOS JUS SS Table 2 Experimental Periods Arranged Alphabetically By Subjects' Initials (continued) Period C El E2 E3 E4 PI E5 E6 E7 P2 Time on^5 Collection (days) 202 98 196 112 112 14 112 112 112 108 Off0 Time (days) Rate of*1 .6 ug/m3 1,2 ug/m3 1.9 ug/m3 2.4 ug/m3 3.3 ug/m3 3.6 ug/m3 4.0 ug/m3 C 166 22 El 140 E2 112 E3 60 2.4 ug/m3 3.7 ug/m3 7.5 ug/m3 C E E-DC1 P-DC1 E-DC2 P-DC2 E-DG3 P-DC3 E-DC4 E-DC5 P-DC5 E-DC6 P-DC6 E-DC7 P-DC7 P 31 1095 28 35 28 32 28 14 28 28 33 28 28 14 42 283 16 18 1000.0 ug/day tr V M tr tr tr tr tr tr H tr u tt C 392 21 El 112 E2 112 E3 112 E4 112 P 179 9.4 ug/m3 19.3 ug/m3 27.1 ug/m3 35.7 ug/m3 C 140 E 772 12 P 504 7 28.1 ug/m3 C 129 El 168 E2 108 4 E3 112 E4 112 PI 21 E5 112 E6 108 4 ,6 ug/m3 1.3 ug/m3 1.8 ug/m3 2.4 ug/m3 2.7 ug/m3 3.4 ug/m3 16 TEH 0532040 DUP050033126 SUM Table 2 Experimental Periods Arranged Alphabetically By Subjects' Initials (continued) Subject Period Time on*3 Collection (days) Off0 Time (days) Rate of0 Exposure E7 112 P2 63 27 E8 140 E9 112 E10 140 Ell 105 El 2 112 El 3 113 P3 22 5 4,3 ug/m3 2.4 ug/m3 3.2 ug/m3 5.4 ug/m3 6.2 ug/m3 7.0 ug/m3 7.2 ug/m3 SW * c E P 361 420 63 300.0 ug/day The C, E and P Periods refer to control, exposure and post exposure periods, respectively, "Days during which food, feces, urine and blood samples were collected. cDays in which the subject was off collection for vacation, sickness and other times when samples were not collected. 0 Rates expressed as ug/day refer to the oral experiments. Rates expressed as ug/m3 refer to average 24 hour inhalation exposures calculated over the total experimental period. (See RESULTS). Periods designated as Corn, E-DC's, P-DC's and CNE are discussed in the text. 17 TEH 0532041 DUP050033127 Table 3 Inhalation Chamber Exposure Conditions and Pulmonary Analyses Subject & Exposure Period Concentration (mg/m3)a Chamber Conditions Hours3 Per Day Days Per Week Particle ** Size (microns) Pulmonary Analyses Nc Deposition a % Min. Vol.a (l/min.) MB 0.152/0.027 6.8/0.6 5 50% 0.75 26 54.1/8.3 14.83/1.70 (0.094/0.228) (3.0/7.0) 90% 1.80 (38.7/69.0) (10.70/20,20) MOB 1 0.077/0.012d (0.056/.Ill) 6.7/0.6 (2.5/7.0) 5 50% 0.05 27 39,9/14.8 90% 0.17 (16.0/94.8) 2 0.144/0.026 (0.054/0.223) f 7.0 PB 0.147/0.063 7.0/0.7 (0.032/0.363) (2.0/8.0) 5 5 50% 1.20 18 53.4/11.4 90% 6.0 (24.4/76.5) 50% 0.11 21 51,9/16.7 90% 0.23 (18,4/74.5) 12.12/3.65 (5.55/17,80) 9.56/1.30 (7.60/13.50) SB 0,153/0.015 6.2/2.2 5 50% 0.05 67 34.0/5.2 18.50/1.89 (0.095/0.200) (3.0/10.0) 90% 0.17 (13.6/45.2) (12.50/22.00) FC 1 0.288/0.183 6.9/0.2 (0.153/0.624) (6.5/7.0) 5 50% 0.05 90% 0.17 2 46.5/0.7 (46.0/47.0) 13.08/2.90 (11.03/15.13) 2 0.154/0,015 (0.107/0.220) 7.0/0.2 (5.0/7.0) 5 Same 15 34.6/9.6 (19.3/48.5) 10.11/1.12 (8.20/11.60) 3 0.152/0.067 (0.056/0.850) 7.0/0.5 (3.0/8.0) 5 50% 0,90 9 43.2/13.4 17.37/3,09 90% 2.00 (20.6/60.5) (13.40/21.00) max 4.00 LD 1 0.150/0.012 3.0/0.0 (0.123/0.193) (3.0/3.0) 3.5 50% 0.05 16 40.2/4.0 17.25/2.10 90% 0.17 (33.3/49.3) (13.40/23.60) 2 0.154/0.014 (0.113/0,182) 6.0/0.0 (6.0/6.0) 3,5 50% 0.05 16 40.6/10.4 17.36/1.56 90% 0.17 (20.7/70.5) (14.30/20.00) 3 0.147/0.013 (0.120/0.167) 9.0/0.3 (7.0/10.0) 3.5 Same 38.7/3.7 (30.3/44.5) 17.50/2.00 (14.10/20.70) 4 0.151/0.012 (0.114/0.174) 11.9/0.7 (8.0/12.0) 3.5 Same 37.2/3.5 (28.7/42.5) 19.05/1,04 (16.90/21.00) DH 1 0.021/0.003 7.6/0.8 (0.011/0.029) (3.0/8.0) 6 50% 0.05 90% 0.17 9 52.5/15.3 (17.2/69.0) 10.53/0.87 (9.00/11.70) 2 0.021/0.003 9.7/0.5 6 Same (0.015/0.030) (8.0/10.0) 11 45.0/16.5 (7.0/61.6) 9.20/0.86 (7.70/10.60) 3 0.020/0.003 11,3/0.9 6 Same (0.014/0.023) (8.0/13.0) 13 57.0/6.2 (48.8/69.0) 9.82/0.89 (8.20/11.30) 4 0.021/0.008 13.0/1.3 6 Same (0.014/0.074) (4.0/15.0) 9 50.7/17.8 (18,7/74.4) 9.29/1.14 (7.60/11.00) 18 TEH 0532042 DUP050033128 Table 3 <* Inhalation Chamber Exposure Conditions and Pulmonary Analyses (continued) Chamber Conditions Pulmonary Analyses Subject & Exposure Period Concentration (mg/m*) Hours3 Per Day Days Per Week Particle b Size (microns) N c Deposition3 % Min. Vol.a (I/m In.) NK 1 0.009/0.001 3.0/0.0 (0.007/0.012) (3.0/3.0) 3.5 50% 0.05 10 36.1/7.2 18.39/0.60 90% 0.17 (25.3/48.2) (17.10/19,10) 2 0.010/0.001 (0.008/0.14) 6.0/0.0 (6.0/6.0) 3.5 Same 26 37.5/11.2 (13.5/55.5) 19,0/0.62 (17.40/20.50) 3 0.010/0.002 (0.007/0.015) * 4 0.010/0.001 (0.008/0.013) 9.0/0.0 (9.0/9.0) 11.9/0.7 (7.0/12.0) 3.5 Same 3.5 Same 9 44.4/4.4 (39.2/52.0) 15 34.5/8.8 (24.0/48.5) 19.87/0.94 (18.80/21.40) 19.07/0.86 (17.30/21.30) $ 0.010/0.001 (0.008/0.013) 9.0/0.1 (8.Q/9.0) 6 Same 14 33.5/9.9 (11.2/51.0) 18.32/0.97 (17.20/19.70) 6 0.009/0.001 (0.007/0.013; 10.9/0.8 (5.0/11.0) 6 50% 0.05 90% 0.17 3 32.9/2.2 (30.6/35.0) 17,97/1.80 (15.90/19.20) 7 0.010/0.002 (0.001/0.013) 12.0/0.2 (10.0/12.0) 6 Same 7 59.6/5.3 (52.0/66.0) 10.50/1.13 (9.60/12.90) HR 1 0.020/0.002 3.5/0.5 (0.011/0.035) (2.0/4.0) 6 50% 0.05 19 71.1/5.9 90% 0.17 (53.6/79.6) 8.43/0.62 (7.30/9.4) 2 0.020/0.003 (0.014/0.042) 5.2/0.4 (5.0/6.0) 6 Same 12 67.1/4.1 (61.0/74.0) 8.27/0.54 (7.50/9.10) 3 0.020/0.002 10.4/0.7 6 Same (0.011/0.024) (7.0/11.0) 5 54.5/21.2 (27.4/70.5) 8.56/0.79 (7.60/9.50) JOS 1 0.148/0.011 (0.128/0.177) 3.0/0.0 (3.0/3.0) 3.5 50% 0.05 14 38.20/5.1 20.51/2.23 90% 0.17 (31.1/48.2) (16.00/23.60) 2 0.157/0.012 (0.187/0.136) 6.0/0.0 (6.0/6.0) 3.5 Same 15 31.4/5.9 (21.4/39.0) 17.69/1.22 (16.40/20.20) 3 0.148/0.011 (0.108/0.168) 9.0/0.3 (7.0/9.0) 3.5 Same 16 30.5/6.4 (20.4/46.8) 17.09/1.25 (15.20/19.40) 4 0.147/0.011 (0.119/0.168) 11.9/0.4 (9,0/12.0) 3.5 Same 16 34.3/4.4 (24.6/41.7) 16,59/1.13 (13,90/18.40) JUS 0.143/0.033 7.0/0.0 5 50% 1.20 15 64.2/10.4 16.33/0.51 (0.004/0.234) (7.0/7.0) 90% 5.00 (34.0/72.0) (15.60/17.10) max 15.00 ss 1 0.010/0.002 3.0/0.0 (0.007/0.020) (3,0/3.0) 3.5 50% 0.05 20 36.8/8.1 19.00/1.3 90% 0.17 (15.9/45.2) (16.10/21,70) 19 TEH 0532043 DUP050033129 Table 3 Inhalation Chamber Exposure Conditions and Pulmonary Analyses (continued) Chamber Conditions Pulmonary Analyses Subject & Exposure Period Concentration (mg/m3)a Hours3 Per Day Days Per Week Particle13 Size (microns) Nc Deposition % Min. Vol. (i/min.) SS 2 0.010/0.002 6.Q/0.0 (0.008/0.015) (6.0/6.0) 3.5 Same 12 35.7/9.8 (18.8/48.5) 19.07/1.33 (16.70/20.60) 3 0.010/0.001 (0.008/0.013) 8.9/0.5 (5.0/9.0) 3.5 Same 14 28.3/8.6 (11.8/40.0) 18.82/1.33 (17.20/21.90) 4 0.010/0.001 (0.00/0.01) 4 5 0.009/0.002 (0.002/0.013) 12.0/0.0 (12.0/12.0) 8.9/0.8 (3.0/9.0) 3.5 Same 6 Same 12 29.5/10.3 (13.7/41.0) 2 20.3/2.3 (18.6/21.9) 18.50/1.19 (16.70/20.00) 18.65/3.16 (16.40/20.90) 6 0.010/0.001 10,9/0.6 6 Same (0.001/0.012) (6.0/11.0) 8 54.6/8,3 (37.3/64.0) 7.03/0.69 (6.40/8.40) 7 0.010/0.002 (0.005/0.016) 12.0/0.0 (12.0/12.0) 6 Same 13 48.4/12.6 (24.0/69.0) 7.64/0.98 (5.40/8.90) 8 0.020/0.002 (0.13/0.025) 3.5/0.5 (3.0/4.0) 6 50% 0.05 19 57.4/7.1 90% 0.17 (41.0/71.0) 9.17/0.83 (7.50/10.60) 9 0.020/0.003 (0.014/0.040) 5.2/0.4 (5.0/6.D) 6 Same 12 52.4/14.8 (31.0/72.0) 8.87/0.78 (7.20/10.10) 10 0.020/0.004 (0.008/0.049) 6.8/0.5 (5.0/7.0) 6 50% 0.05 13 56.5/6.9 9.43/0.68 90% 0.17 (47.2/69.5) (7.90/10.50) 11 0.019/0.003 (0.010/0.030) 8.7/0.5 (7.0/9.0) 6 Same 14 51.9/6.0 (41.8/62.0) 9.21/0.40 (8.60/9.90) 12 0.019/0.003 10,5/0.5 6 Same (0.013/0,030) (9.0/11.0) 12 47.0/9.0 (38,3/73.8) 8.85/0.63 (8.00/9.80) 13 0.018/0.003 12.1/0.8 6 Same (0,012/0.027) (6.0/13.0) 6 38.4/11.6 (21,3/54.8) 9.37/0.64 (8.70/10,40) aMeans/SD over (minimum/maximum values) b Particle size data obtained from a summary table prepared by Larry Schafer, supervisor of the chamber operations. cThe N'S represent the number of deposition and respiratory rate determinations. d Based on the 27 deposition analyses, rather than daily samples. e Assumed to be 7 hours per day and 5 days per week taken from Larry Schafer's summary table. Data were not recorded on the original data sheets. 20 TEH 0532044 DUP0500331 Subject & Period & Nc (days) Table 4 Arithmetic Data Summary For Individuals a Diet (mg/day) Feces d (mg/sample) Urine (mg/day) Blood (mg/IOOg) Balance (mg/day) EB C E PI P2 56 507 769 43 MB C E P 4 146 194 563 MOB C El Pi CORN PCORN E2 P2 244 489 727 11 92 245 292 FB C E P 232 98 15 SB C E P 384 365 239 FC C El PI 536 5 23 0.334/0.140 (0.140/0.810) 2.182/0.250 (1.460/3.330) 0.293/0.137 (0.060/1.170) 0-299/0.108 (0.120/).640) 0.333/0.172 (0.070/0.740) 1.880/0.991 (0.300/6.000) 0.304/0.195 (0.050/1.550) 0.249/0.099 (0.120/0.480) 0.037/0.012 (0.014/0.065) 0.117/0.034 (0.001/0.240) 0.052/0.025) (0.001/0.180) 0.040/0.012 0.021/0.068) 0.027/0.005 (0.025/0.035) 0.060/0.015 (0.007/0.100) 0.034/0.009 (0.004/0.060) 0.029/0.007 (0.020/0.040) -0.021/0.242 (-0.472/0.790) 0.188/1.051 (-3.920/2.477) -0.062/0.232 (-1.320/1.104) -0.006/0.163 (-0.310/0.354) 0.209/0.070 (0.090/0.480) 0.197/0.083 (0.060/0.590) 0.264/0.110 (0.030/0.630) 0.213/0.116 (0.050/0.910) 0.299/0.159 (0.070/0.940) 0.287/0.152 (0.060/1,010) 0.038/0.007 (0.023/0.063) 0.076/0.013 (0.042/0.147) 0.045/0.010 (0.011/0.089) 0.024/0.005 (0.020/0.030) 0.040/0.006 (0.030/0.050) 0.028/0,005 (0.020/0.040) -0,015/0.143 (-0.763/0.386) -0.138/0.195 (-0.895/0.503) -0.024/0.193 (-758/0.556) 0.211/0.087 (0.060/0.570) 0.188/0.099 (0.060/0.570) 0.174/0.098 (0.060/0.600) 3.012/3.664 (0.480/13.620) 0.104/0.050 (0.030/0.300) 0.117/0.065 (0.030/0.420) 0.125/0.096 (0.030/0.600) 0.304/0.208 (0.030/1.200) 0.314/0.199 (0.060/1.230) 0.353/0.253 (0.050/2.250) 4.451/2.887 (2.600/11.350) 0.217/0.117 (0.030/0.690) 0.389/0.203 (0.060/1.080) 0.208/0.139 (0.020/0.930) 0.031/0.008 (0.003/0.054) 0.056/0.012 (0.019/0.110) 0.040/0,013 (0.005/0.093) 0.212/0.055 (0.147/0.348) 0.034/0.009 (0.012/0.058) 0.051/0.011 (0.029/0.091) 0.026/0.009 (0.008/0.064) 0.026/0.009 (0.020/0.060) 0.039/0.008 (0.025/0.065) 0.027/0.007 (0.020/0.055) 0.051/0.006 (0.045/0.060) 0.025/0.006 (0.010/0.030) 0.032/0.005 (0.020/0.040) 0.022/0.004 (0.020/0.030) 0.003/0.229 (-0.870/0.508) -0.046/0.226 (-0.976/0.483) -0.059/0.256 (-1.380/0.934) -0.167/5.472 (-10.753/13.386) -0.080/0.158 (-0.578/0.271) -0.275/0.225 (-1.066/0.023) -0.028/0.189 (-0.888/0.745) 0.134/0.059 (0.030/0.360) 0.115/0.049 (0.030/0.240) 0.134/0.106 (0.060/0.450) 0,217/0.126 (0.020/0.640) 0.259/0.187 (0.030/0.860) 0.530/0.294 (0.200/0.880) 0.025/0.010 (0.008/0.062) 0.036/0.014 (0.005/0.075) 0.034/0.019 (0.010/0.077) 0.023/0.004 (0.014/0.029) 0.033/0.006 (0.023/0,042) 0.032/0.003 (0.030/0.034) -0.009/0.149 (-0.612/0.293) -0.036/0.196 (-0.784/0.369) -0.077/0.310 (-0.791/0.426) 0.107/0.080 (0,030/0.480) 0.109/9.107 (0.030/0.750) 0,082/0.051 (0.030/0.270) 0.110/0.059 (0.030/0.430) 0.167/0.113 (0.040/0.800) 0.121/0,057 (0.030/0.410) 0.024/0.007 (0.009/0.049) 0.051/0.011 (0.023/0.089) 0.024/0.006 (0.010/0.041) 0.021/0.003 (0.019/0.030) 0.032/0.005 (0.019/0.045) 0.020/0.005 (0.007/0.028) -0.023/0.095 (-0.505/0.302) -0.080/0.156 (-0.756/0.687) -0.046/0.086 (-0.380/0.244) 0.238/0.118 (0.060/0.740) 0.182/0.117 (0.090/0.410) 0.138/0.050 (0.090/0.300) 0.200/0.120 (0.040/1.010) 0.127/0.066 (0.050/0.260) 0.133/0.070 (0.050/0.330) 0.022/0.008 (0.003/0.052) 0.024/0.007 (0.017/0.041) 0.019/0,004 (0.012/0.032) 0.022/0.006 (0.010/0.045) 0.020/N=1 (0.020/0.020) 0.020/0.0 (0.020/0.020) 0.021/0.134 (-0.732/0,544) 0.036/0.125 (-0.127/0.289) -0.009/0.090) (-0.272/0.130) 21 TEH 0532045 DUP050033131 Table 4 Arithmetic Data Summary For Individuals a (continued) Subject & Period b E2 P2 E3 P3 N (days) 477 397 225 360 Diet (mg/day) 0.218/0.104 (0.060/0.710) 0.160/0.079 (0.060/0.490) 0.128/0.067 (0.030/0.480) 0.138/0.080 (0.030/0.600) Feces d (mg/sample) 0.240/0.147 (0.050/1.200) 0,140/0.064 (0.030/0.420) 0.249/0.097 (0.030/0.640) 0,138/0.088 (0.040/0.650) Urine (mg/day) 0.076/0.021 (0.022/0.166) 0.023/0.010 (0.010/0.080) 0.071/0.016 (0.033/0.126) 0.022/0.007 (0.008/0.049) Blood (mg/IOOg) 0.039/0.010 (0.020/0.070) 0.020/0,005 (0.008/0.040) 0.031/0.006 (0.020/0.040) 0.021/0.002 (0.020/0.030) Balance (mg/day) -0.095/0.167 (-0.976/0.626) -0.004/0.090 (-0.333/0.341) -0.192/0.115 (-0.653/0.243) -0.020/0.102 (-0.488/0.390) LD C El E2 E3 E4 P 463 * 57 58 56 57 99 0.139/0.184 (0.030/3.220) 0.101/0.060 (0.030/0.270) 0.162/0.059 (0.090/0.420) 0.340/0.343 (0.060/1.320) 0.079/0.043 (0.030/0.240) 0.102/0.049 (0.030/0.420) 0.262/0.740 (0.020/12.120) 0,251/0.129 (0.060/0,660) 0.303/0.159 (0.090/0,770) 0.667/0.560 (0.100/2.200) 0.307/0.179 (0.070/1.020) 0.215/0.090 (0.060/0.460) 0.019/0.007 (0.004/0.045) 0.037/0.011 (0.020/0.077) 0.056/0.012 (0.032/0.083) 0.086/0.020 (0.044/0.134) 0.086/0.020 (0.041/0.132) 0.028/0,006 {0.014/0.049) 0,018/0.005 (0.007/0.034) 0.029/0.012 (0.019/0.058) 0.036/0.008 (0.023/0.047) 0.040/0.007 (0.026/0.049) 0.041/0.003 (0.037/0.048) 0.023/0.004 (0.016/0.032) -0.048/0,443 (-8.231/3.195) -0.096/0.162 (-0.485/0.219) -0.058/0.243 (-0.689/0.947) -0.180/0,579 (-2.Q52/1.082) -0.190/0.212 (-1.042/0.118) -0.053/0.161 (-0.369/0.635) IF C E P 339 0.237/0.119 0.261/0.157 0.032/0.016 0.027/0.007 -0.024/0.204 (0.004/0.990) (0.020/1.240) (0.010/0.090) (0.015/0.045) (-1.122/0.932) 56 3.218/0.433 3,227/1.400 0.081/0.018 0.046/0.008 0.371/1,811 (0.315/3.720) (0.150/6.250) (0.043/0.142) (0,030/0.055) (-4.506/3.587) 85 0.162/0.076 0.225/0.140 0.036/0.013 0.040/0.012 -0.069/0.168 (0.030/0.450) (0.020/0,890) (0.014/0,068) (0.030/0.075) (-0.844/0.283) DH C CNE El E2 E3 E4 P 224 0.097/0.058 0.330/0.258 0.045/0.012 0.030/0.006 -0.103/0.234 (0.030/0.420) (0.090/1.760) (0.018/0.087) (0.021/0.053) (-1.393/0.655) 15 0.079/0.038 0,174/0.087 0.050/0.009 0,025/0.001 -0.038/0.147 (0.030/0.150) (0.050.0.340) (0.027/0.063) (0,024/0.026) (-0.272/0.313) 57 0.096/0.055 0.188/0.080 0.046/0.011 0.031/0.005 -O.071/Q.125 (0.030/0.240) (0.040/0.380) (0.025/0.072) (0.025/0.043) (-0,268/0.436) 57 0.097/0.065 0.175/0.081 0.040/0.016 ' 0.026/0.004 -0.044/0.145 (0.030/0.390) (0.050/0.360) (0.017/0.083) (0.019/0.030) (-0.534/0.475) 57 0.104/0.073 0.232/0.149 0.047/0.012 0.029/0.004 -0.094/0.181 (0.030/0.390) (0.060/0.740) (0.021/0.075) (0.022/0.034) (-0.728/0.229) 57 0.071/0.028 0.190/0.115 0.045/0.015 0.028/0.003 -0.099/0.136 (0.030/0.150) (0.060/0.560) (0.018/0.075) (0.023/0.032) (-0.545/0.109) 25 0.079/0.044 0.214/0.125 0.035/0.010 0,027/0.002 -0.066/0.145 (0.030/0.240) (0.050/0.620) (0.020/0.070) (0.023/0.029) (-0.636/0.165) NK C El E2 E3 E4 202 0.141/0.071 0.200/0.095 0.027/0.006 0.020/0.003 -0.083/0.098 (0.030/0.360) (0.050/0.570) (0.009/0.045) (0.014/0.026 (-0.484/0.341) 50 0.168/0.114 0.165/0.070 0.031/0.006 0.020/0.004 -0.007/0.269 (0,060/0.600) (0.060/0.390) (0.019/0.047) (0.018/0.028) (-1.017/0.873) 90 0.140/0.073 0.160/0.067 0.030/0.005 0.021/0.003 -0.053/0.104 (0.060/0.530) (0.070/0.550) (0.013/0.045) (0.015/0.027) (-0.554/0.346) 57 0.151/0.050 0.153/0.049 0.032/0.006 0.023/0.003 -0.035/0.080 (0.060/0.300) (0.050/0.240) (0.015/0.047) (0.018/0.029) (-0.261/0.242) 57 0.151/0.192 0.208/0.316 0.037/0.008 0.026/0.004 -0.090/0.263 (0.060/1.170) (0.020/1.720) (0.025/0.064) (0.019/0.031) (-1.570/0.434) TEH 0532046 DUP050033132 Table 4 Arithmetic Data Summary For Individuals3 (continued) Subject & Period Nc (days) Diet (mg/day) Feces d (mg/sample) Urine (mg/day) Bipod (mg/IOOg) Balance (mg/day) PI 8 0.135/0.058 0.147/1.069 0.035/0.004 0.025/N=2 -0.054/0.031 (0.060/0.240) (0.060/0.230) (0.030/0.043) (0.025/0.025) (-0.087/-0.003) E5 57 0.122/0.066 0.126/0.054 0.037/0.006 0.026/0.005 -0.041/0.089 (0.030/0.360) (0.040/0.300) (0.024/0.057) (0.019/0.035) (-0.242/0.206) E6 57 0.298/0.181 0.146/0.067 0.045/0.008 0.030/0.002 0.109/0.170 (0.060/0.750) (0.030/0.300) (0,028/0,065) (0.028/0.034) (-0.171/0.510) E7 57 0.137/0.078 0,146/0.073 0.038/0.008 0.029/0.006 -0.043/0,131 (0.030/0.420) (0.020/0.430) (0.020/0.055) (0.021/0.043) (-0.438/0.343) P2 55 0.223/0.119 0.123/0.078 0.036/0.008 0.023/0.002 0.065/0.140 (0.030/0.690) (0.030/0.510) (0.019/0.053) (0.019/0.026) (-0.266/0.594) C * 166 0.156/0.095 0.309/0.169 0.027/0.010 0.021/0.003 0.025/0.231 (0.030/0.690) (0.040/0.850) (0.006/0.063) (0,017/0.029) (-0.610/0.913) El 71 0.086/0.054 0.281/0.117 0.025/0.008 0.025/0.007 -0.053/0.170 (0.030/0.270) (0.050/0.640) (0.009/0.051) (0.019/0.045) (-0.587/0.242) E2 57 0.065/0.039 0.321/0.122 0.027/0.011 0.021/0,003 -0.095/0.190 (0.030/0.210) (0.140/0.660) (0.009/0.049) (0.017/0.027) (-0.595/0.166) E3 31 0.082/0,044 0.377/0.136 0.036/0.014 0.027/0.004 -0.094/0.227 (0.030/0.210) (0.200/0.720) (0.007/0.074) (0.024/0.034) (-0.686/0.343) C E E-DC1 P-DC1 E-DC2 P-DC2 E-DC3 P-DC3 E-DC4 E-DC5 P-DC5 E-DC6 P-DC6 E-DC7 P-DC7 P 31 0.261/0.147 0,425/0.286 0.024/0.012 0.036/0.010 -0.106/0.423 (0.030/0.790) (0.010/1.300) (0.013/0.070) (0.025/0.055) (-1.051/0.940) 956 1.333/0.227 1.409/0.782 0.079/0.028 0.053/0.011 0.069/0.925 (0.045/2.700) (0.090/4.780) (0.016/0.222) (0.025/0.095) (-3.609/3.600) 15 1.546/0.497 1.429/0.468 0.089/0.033 0.052/0.004 0.123/0.738 (1.050/2.860) (0.730/2.430) (0.050/0.156) (0.050/0.055) (-1.272/1.460) 35 1.247/0.152 1.510/0.892 0.086/0.024 0.067/0.004 0.049/1.032 (1.050/1.730) (0.920/4.280) (0.040/0.122) (0.065/0.070) (-3.143/1.197) 15 1.611/0.369 1.583/0.492 0.076/0.018 0.072/0.004 0.057/0.862 (1.120/2.380) (0.830/2.300) (0,045/0.115) (0.070/0.075) (-0.788/2.280) 17 1.172/0.161 1.168/0.544 0.065/0.014 0.062/0.004 0.214/0,654 (0.850/1.400) (0.230/2.130) (0.034/0.085) (0.060/0.065) (-1.168/1.046) 15 1.229/0.204 1.213/0.396 0.066/0.017 0.055/0.007 0.192/0.601) (0.980/1.830) (0.530/1.830) (0.044/0.100) (0.050/0.060) (-0.750/1,297) 8 1.552/0.489 0.995/0.422 0.056/0.023 0.060/N=1 0.750/0.738 (1.140/2.420) (0,500/0.750) (0.020/0.093) (0.060/0.060) (-0.583/1.538) IS 1.378/0.254 1.598/0.741 0.067/0.014 0.057/0.004 0.139/1.040 (1.130/2.030) (0.590/2.790) (0.038/0.100) (0.055/0.060) (-1.722/1.930) 15 1.210/0.221 1.315/0.646 0.097/0.031 0.047/0.004 -0.027/0.821 (1.030/1.830) (0.320/2.370) (0.056/0.165) (0.045/0.050) (-1.292/1.350) 17 1.258/0.198 1.982/1.135 0.126/0.049 0.076/0.036 -0.179/1.220 (0.860/1.820) (0.600/4.000) (0.050/0.276) (0.054/0.120) (-2.740/1.211) 15 1.337/0.114 1,429/0.461 0.091/0.018 0.072/0.018 -0.107/0.580 (1.170/1.540) (0,600/2.120) (0.062/0.120) (0.060/0.085) (-0.997/1.298) 15 1.425/0,210 1.641/0,617 0.125/0.054 0.056/0.005 -0.013/0,878 (1.080/1.930) (0.640/2.430) (0.066/0.300) (0.053/0.060) (-1.210/1.260) 8 1.267/0.090 1.326/0.331 0.094/0.042 0.065/N=1 0.013/0.580 (1.170/1.440) (0.930/1.840) (0.052/0.187) (0.065/0.065) (-0.662/1.148) 22 1,351/0.196 1.767/0.971 0.041/0.035 0.061/0.005 0.067/1.227 (1.170/1.800) (0.680/3.650) (0.010/0.110) (0.055/0.065) (-2.440/1.662) 144 0.236/0.109 0.319/0.218 0.055/0.024 0.041/0.006 -0.038/0.242 (0.090/0.690) (0.020/1.670) (0.014/0.137) (0,035/0.050) (-1.270/0.550) TEH 0532047 DUP050033133 Table 4 Arithmetic Data Summary For Individuals 9 (continued) Subject & Period b Nc (days) Diet (mg/day) Feces b (mg/sample) Urine (mg/day) Blood (mg/IOOg) Balance (mg/day) JOS C El E2 E3 E4 P 392 57 57 57 57 * 0 0.112/0.061 (0.030/0.360) 0.119/0.056 (0.030/0.300) 0.191/0.087 (0.090/0.570) 0.138/0.045 (0.060/0.270) 0.116/0.060 (0.060/0.270) 0.139/0.069 (0.030/0.420) 0.237/0.183 (0.020/1.040) 0.231/0.133 (0.040/0.710) 0.241/0.155 (0.040/0.740) 0.253/0.200 (0.040/0.770) 0,247/0.177 (0.030/0.860) 0.260/0.181 (0.030/1.010) 0,020/0.005 (0.008/0.036) 0.035/0.009 (0.021/0.074) 0.057/0.011 (0.030/0.090) 0.063/0.011 (0.035/0.091) 0.076/0.016 (0.011/0.122) 0,031/0.007 (0.015/0.053) 0.021/0.004 (0.012/0.029) 0.032/0.004 (0.026/0.039) 0.037/0.005 (0.029/0.043) 0.041/0.007 (0.026/0.048) 0.046/0.004 (0.036/0.051) 0.027/0.003 (0.022/0.033) -0.010/0.182 (-0.789/0.674) -0.058/0,173 (-0.618/0.274) -0.014/0.222 (-0.684/0.770) -0.062/0.203 (-0.757/0.206) -0.110/0.203 (-0.895/0.151) -0.063/0.214 (-0.928/0.674) JUS C E P 140 0,169/0.074 0.178/0.083 0.024/0.011 0.021/0.005 0.002/0.117 (0.060/0.480) (0.050/0.450) (0.005/0.054) (0.010/0.030) (-0.342/0,432) 633 0.218/0.095 0.439/0.198 0.045/0.012 0.032/0.006 -0.171/0.273 (0.060/0.690) (0.050/1.430) (0.015/0.099) (0.020/0.050) (-1.328/0.594) 365 0.110/0.065 0.141/0.062 0.020/0.005 0.019/0.005 -0.023/0.102 (0.030/0.480) (0.020/0.420) (0.009/0.035) 0.011/0.040) (-0.510/0.347) SS C El E2 E3 E4 PI E5 E6 E7 P2 B8 E9 E10 Ell El 2 El 3 129 0.146/0.097 0.237/0.142 0.025/0.006 0.019/0.003 -0.091/0.200 (0.030/0.600) (0.030/0.620) (0.008/0.046) (0,014/0.024) (-0.644/0.704) 85 0,164/0.112 0.228/0.117 0.025/0.006 0.020/0.003 -0.012/0.166 (0.030/0.540) (0.020/0.490) (0.013/0.044) (0.015/0.025) (-0.385/0.517) 55 0.217/0.1567 0.328/0.139 0.027/0.008 0.020/0.293 -0.004/0.293 (0.060/0.870) (0.090/0.590) (0.015/0.054) (0.011/0.027) (-1.010/0.511) 57 0.088/0.046 0.216/0.172 0.023/0.006 0.018/0.002 -0.071/0.179 (O.O30/O.21O) (0.030/0.740) (0.005/0.039) (0.015/0.022) (-0.706/0.188) 57 0.149/0.081 0.261/0.161 0.027/0.007 0.019/0.004 -0.037/0.197 (0.030/0.420) (0.040/0.730) (0.017/0.043) (0.016/0.027) (-0.615/0.388) 11 0.172/0.060 0.276/0.140 0.028/0.012 0.017/0.004 -0.016/0.186 (0.090/0.270) (0.080/0.510) (0.010/0.046) (0.014/0.020) (-0.400/0.214) 57 0.222/0.169 0.510/0.259 0.035/0.009 0.023/0.003 -0.044/0.324 (0.060/0.810) (0.090/1.080) (0.023/0.058) (0.019/0.028) (-0.941/0.667) 55 0.156/0.105 0.297/0.160 0.029/0.010 0.024/0.002 -0.003/0.243 (0.060/0.600) (0.120/0,850) (0.006/0.059) (0.020/0.026) (-0.761/0.935) 57 0.219/0.125 0.285/0.145 0.035/0.010 0.024/0,004 0.045/0.252 (0.090/0.610) (0.110/0.740) (0.020/0.059) (0,015/0.030) (-0.649/0.837) 32 0.245/0.180 0.235/0.132 0.031/0.006 0.021/0.002 0.057/0.265 (0.030/0.780) (0.060/0.570) (0.019/0.042) (0.018/0.023) (-0.449/0.761) 71 0.132/0.105 0.212/0.088 0.024/0,006 0.024/0,003 -0.006/0.188 (0.030/0.570) (0.050/0,470) (0.011/0.045) (0.020/0.032) (-0,317/0.641) 57 0.171/0.103 0.314/0.191 0.027/0.007 0.021/0.005 -0.027/0.252 (0.030/0.570) (0.110/1.040) (0,011/0.045) (0.015/0.031) (-0.822/0.628) 57 0,206/0.132 0.309/0.161 0.033/0.008 0.027/0.003 -0.011/0.258 (0.060/0.720) (0.090/0.900) (0.017/0.055) (0.023/0.032) (-0.780/0.704) 53 0.164/0.108 0.236/0.135 0.035/0.010 0.026/0.003 0.000/0.213 (0.020/0.570) (0.020/0.510) (0.018/0.056) (0.022/0.030) (-0,407/0.720) 57 0.213/0.178 0.305/0.166 0.035/0.014 0.026/0.004 0.025/0.339 (0.020/1.270) (0.090/0.740) (0.011/0.075) (0.019/0.033) (-0.635/1.407) 57 0.290/0.213 0.216/0.123 0.038/0.011 0.029/0.006 0.098/0.256 (0.030/1.110) (0.040/0.540) (0.010/0.067) (0.024/0.041) (-0.517/0.818) TEH 0532048 DUP050033134 ' ;-v: ;c Subject & Period15 Table 4 Arithmetic Data Summary For Individuals a (continued) > Nc (days) Diet (mg/day) Fecesa (mg/sample) Urine (mg/day) Blood (mg/IOOg) Balance (mg/day) P3 12 0.460/0.304 0.436/0.199 0.037/0.009 0.036/N=1 0.169/0.427 (0.090/0.900) (0.190/0.740) (0.024/0.056) (0.036/0.036) (-0.537/0.825) . SW a; S. m&m?- C E P 361 0.199/0.104 0.265/0.138 0.040/0.016 0.040/0.009 -0.031/0.196 (0.050/0.710) (0.030/0.820) (0.015/0.086) (0.025/0.060) (-0.689/0.792) 281 0.507/0.103 0.542/0.245 0.043/0.016 0.039/0.007 0.026/0.329 (0.300/0.930) (0.100/1.430) (0.014/0.097) (0.020/0.060) (-0.942/0.713) 32 0.284/0.160 0.398/0.195 0.029/0.008 O.025/N-4 -0.030/0.255 (0.120/0.780) (0.150/0.930) (0.015/0.044) (0.025/0.025) (-0.590/0.778) v aDatashown as mean/SD over (minimum/maximum values). r. &The C, E and P Periods refer to control, exposure and post exposure periods, respectively. cIMumber of days represented in the means. See text. ' ** Per sample (rather than per day). See text. |g| 25 TEH 0532049 DUP050033135 Table 5 Logarithmic and Median Data Summary for Individuals Subject & Period Diet (mg/day) Feces13 (mg/sample) Urine (mg/day) Blood (mg/IOOg) Balance (mg/day) EB C E PI P2 0.306/1.517 (0.320) 2.168/1.119 (2.162) 0.269/1.489 (0.269) 0.282/1.416 (0.280) 0.287/1.790 (0.305) 1.637/1.718 (1.701) 0.256/1.745 (0.254) 0.231/1.492 (0.223) 0.034/1.449 (0.035) 0.112/1.439 (0.110) 0.046/1.656 (0.047) 0.038/1.358 (0.038) 0.027/1.169 (0.027) 0.057/1.387 (0.057) 0.033/1.459 (0.035) 0.028/1.291 (0.029) (-0.057) (0,356) (-0.042) (-0.001) MB C E P 0.199/1.368 * (0.185) 0.182/1.476 (0.178) 0.239/1.607 (0.243) 0.109/1.621 (0.184) 0.264/1.648 (0.265) 0.254/1.648 (0,252) 0.037/1.208 (0.038) 0.075/1.178 (0.075) 0.044/1.262 (0.044) 0.023/1.227 (0.023) 0.040/1.153 (0.040) 0.027/1.200 (0.029) (-0.012) (-0.118) (-0.020) MOB C El PI E2 Corn PCorn P2 1.196/1.442 (0.182) 0.168/1.585 (0.153) 0.159/2,000 (0.148) 0.104/1.589 (0.093) 1.888/1.276 (1.860) 0.095/1.538 (0.095) 0.115/2.958 (0.098) 0.247/1.954 (0.262) 0.262/1.820 (0.257) 0.290/1.870 (0.294) 0.339/1.726 (0.345) 3.945/1.611 (3.470) 0.189/1.722 (0.191) 0.171/1.892 (0.174) 0.030/1.318 (0.030) 0.055/1.253 (0.056) 0.038/1.365 (0.037) 0.050/1.236 (0.050) 0,206/2.624 (0.214) 0.033/1.330 (0.034) 0.025/1.384 (0.025) 0.025/1.315 (0.024) 0.039/1.208 (0.040) 0.026/1.282 (0.026) 0.032/1.186 (0.031) 0.051/1.127 (0.050) 0.024/1.365 (0.026) 0.021/1.161 (0.021) (0.051) (0.016) (0.009) (-0.261) (-1.206) (-0.073) (-0.018) PB C E P 0.123/1.528 (0.123) 0.105/1.538 (0.106) 0.110/1.800 (0.101) 0.181/1.892 (0.195) 0.198/1.538 (0.214) 0.461/1.841 (0.400) 0.023/1.486 (0.024) 0.033/1.585 (0.035) 0.030/1.683 (0.029) 0.023/1.191 (0.024) 0.033/1.189 (0.034) 0.032/1,091 (0.032) (0.030) (0.027) (0,038) SB C E P 0.089/1.782 (0.088) 0.083/2.000 (0.085) 0.069/1.811 (0.063) 0.097/1.614 (0.095) 0.142/1.750 (0.140) 0.109/1.560 (0.112) 0,023/1.337 (0.023) 0.050/1.253 (0.051) 0.023/1.315 (0.025) 0.021/1.140 (0,020) 0.032/1.180 (0.032) 0,019/1.352 (0.020) (-0.027) (-0.081) (-0.053) FC C El PI E2 0,213/1.592 (0.208) 0.158/1.690 (0,131) 0.130/1.377 (0.125) 0.192/1.578 (0.184) 0.174/1.683 (0.165) 0.114/1.622 (0.107) 0.117/1.667 (0.112) 0.207/1.690 (0.204) 0.021/1.406 (0.021) 0.023/1.318 (0.022) 0.019/1.250 (0.018) 0.073/1,303 (0.073) 26 0.022/1.253 (0.021) 0.020/N=1 0.020/1.000 (0.020) 0.038/1.276 (0.039) (0.020) (-0.008) (-0.003) (-0.088) TEH 0532050 DUP050033136 I Table 5 Logarithmic and Median Data Summary for Individuals8 (continued) Subject & Period Diet (mg/day) Fecesb (mg/sample) Urine (mg/day) Blood (mg/IOOg) Balance (mg/day) P2 0.145/1.560 0.129/1.510 0.021/1.419 0.020/1.268 (0.147) (0.127) (0.020) (0.020) (-0.007) E3 0.114/1,626 0.230/1.514 0.070/1.259 0,301/1.216 (0.113) (0.244) (0.070) (0.030) (-0.182) P3 0.120/1.702 0.120/1.671 0.021/1.349 0.021/1.107 (0.121) (0.119) (0.021) (0.020) (-0.020) LD C 0.099/2.138 (0.092) El 0.085/1.841 * E2 (0.085) 0.191/3.404 (0.156) 3 0.236/3.420 (0.149) E4 0.071/1.596 (0.067) P 0.093/1.552 (0,097) 0.161/2.198 (0.160) 0.220/1,726 (0.225) 0.266/1.679 (0.280) 0.480/2.317 (0.455) 0.261/1.845 (0.298) 0.197/1.538 (0.195) 0.017/1.483 (0.018) 0.035/1.315 (0.035) 0.054/1.253 (0.055) 0,084/1.274 (0.086) 0.083/1.288 (0,087) 0.027/1.262 (0.027) 0.017/1.321 (0.018) 0.028/1.400 (0.026) 0.035/1.250 (0.035) 0.039/1.227 (0,041) 0.040/1.076 (0.039) 0.023/1.194 (0.022) (-0,026) (-0.100) (-0.006) (-0.186) (-0.166) (-0.074) IF G P 0.225/2.051 (0.206) 3.133/1.374 (3.247) 0.148/1.549 (0.148) 0,222/1.791 (0.224) 2.799/1.914 (3.085) 0.191/1.849 (0.199 0.028/1.596 (0.027) 0.079/1.256 (0.080) 0.033/1.476 (0.034) 0.027/1.268 (0.025) 0.045/1.208 (0.047) 0.038/1.274 (0.036) (-0.024) (0.131) (-0.067) DH C El E2 E3 E4 P NK C 1 2 E3 E4 PI 0.084/1.862 (0.089) 0.094/3.000 (0.086) 0.081/1.803 (0.088) 0.087/1.734 (0.073) 0.065/1.528 (0.067) 0.070/1.622 (0.071) 0.125/1.651 (0,124) 0.212/5.236 (0.137) 0.127/1.510 (0.123) 0.160/2.518 (0.144) 0.114/1.849 (0.106) 0.124/1.560 (0.135) 0,267/1.862 (0.242) 0.171/1.574 (0.175) 0.155/1.706 (0.175) 0.196/1.778 (0.183) 0.163/1.754 (0.169) 0.183/1.803 (0.185) 0.182/1.542 (0.174) 0.152/1.500 (0.144) 0.150/1.406 (0.145) 0.144/1.429 (0.149) 0.134/2.296 (0.131) 0.132/1.702 (0.145) 0.043/1.327 (0.044) 0.045/1.285 (0.047) 0.037/1.462 (0.035) 0.046/1.300 (0.047) 0.043/1.426 (0.044) 0.034/1.312 (0.035) 0.027/1.262 (0.027) 0.030/1.196 (0.030) 0.029/1.211 (0.030) 0.031/1.230 (0.032) 0.036/1.219 (0.036) 0.035/1.132 (0.034) 0.029/1.205 (0.029) 0.030/1.167 (0.030) 0.026/1.202 (0,028) 0.029/1.159 (0.029) 0.028/1.104 (0,029) 0.027/1.096 (0.028) 0.020/1.178 (0,019) 0.020/1.172 (0.019) 0.021/1.148 (0.020) 0.022/1,153 (0.023) 0.025/1.167 (0.026) (-0.028) (-0.077) (-0.033 (-0.036) (-0.078) (-0.010) (-0.079) (-0.047) (0.047) (-0.037) (-0.058) (-0.063) 27 TEH 0532051 DUP050033137 Subject & Period E5 E6 E7 P2 HR C s? El E2 E3 MR C E DC1 NPDC1 DC2 NPDC2 DC3 NPDC3 DC4 DCS NPDC5 DC6 NPDC6 DC7 P JDS C Table 5 Logarithmic and Median Data Summary for Individuals (continued) Diet (rng/day) 0,134/3.972 (0.104) 0.243/1.968 (0.274) 0.120/1.671 (0.122) 0.219/2.716 (0.200) 0.136/1.675 (0.145) 0.073/1.803 (0.072) 0.056/1.722 (0.057) 0.071/1.738 (0.077) 0.224/1.832 (0.240) 1.312/1,208 (1.288) 1.483/1.330 (1.290) 1.239/1.119 (1.230) 1.574/1.239 (1.550) 1.161/1.153 (1.227) 1.216/1.161 (1.152) 1.490/1.340 (1.275) 1.358/1.186 (1.327) 1.194/1.178 (1.147) 1.245/1.167 (1.240) 1.334/1.089 (1.367) 1.413/1.153 (1.360) 1.265/1.072 (1.245) 0.216/1.496 (0.210) 0,111/2,858 (0.093) Feces13 (mg/samp!e) 0.114/1.578 (0.115) 0.131/1.648 (0.135) 0.128/1.721 (0.140) 0.107/1.660 (0.104) ;Urine (mg/day) 0.037/1.186 (0.034) 0.044/1.208 (0.044) 0,037/1,245 (0.039) 0.035/1,271 (0.036) 0.259/1.905 (0.276) 0.257/1.592 (0.275) 0.301/1.442 (0.310) 0.358/1.400 (0.350) 0.025/1.500 (0,025) 0.024/1.403 (0.023) 0.025/1.545 (0.025) 0.033/1.567 (0.036) 0.316/2.692 (0.345) 1,202/1.816 (1.280) 1.368/1.400 (1.360) 1.361/1.528 (1.205) 1.507/1.400 (1.610) 1.002/1.919 (1.340) 1.148/1.435 (1.105) 0.927/1.510 (0.860) 1.426/1.690 (1.580) 1.127/1.879 (1.240) 1.683/1.849 .. (1.780) 1.346/1.462 (1.500) 1.514/1.567 (1.695) 1.291/1.483 (1.170) 0.266/1.862 (0.275) 0.022/1.50Q (0.020) 0.074/1.435 (0.076) 0.084/1.422 (0.082) 0.082/1.396 (0.093) 0.074/1.262 (0.070) 0.063/1.279 (0.066) 0.064/1.285 (0.061) 0.051/1.000 (0.050) 0.065/1.253 (0.065) 0.093/1.361 (0.091) 0.118/1.449 (0.124) 0.089/1.230 (0.090) 0.117/1.416 (0.116) 0,088/1.483(0.085) 0.050/1.560 (0.050) 0.185/2,037 (0.180) 0.019/1.291 (0.020) Blood (mg/IOOg) 0.025/1.205 (0.027) 0.030/1.079 (0.029) 0.029/1.205 (0.028) 0.023/1.102 (0.023) 0.021/1.127 (0.021) 0.021/1.127 (0,021) 0.025/1.265 (0.023) 0.021/1.159 (0.020) 0.035/1.300 (0.035) 0,052/1.242 (0.050) 0.052/1.069 (0,052) 0.067/1.054 (0.067) 0.072/1.050 (0.072) 0.063/1.059 (0.062) 0.055/1.138 (0.055) 0.060/1.000 (0.060) 0.057/1.064 (0.057) 0.047/1.076 (0.047) 0.073/1.538 (0,061) 0.071/1.279 (0.072) 0.056/1.091 (0.056) 0.065/1.000 (0.065) 0.040/1.151 (0.041) 0.020/1.213 (0.021) Balance (mg/day) (-0.061) (0.078) (-0.053) (0.057) (0.064) (0.013) (0.005) (0.004) (-0.128) (0.130) (0.059) (0.135) (-0.035) (0.140) (-0.029) (1.083) (0.168) (-0.058) (0.060) (-0.276) (-0.196) (-0.140) (-0.041) (0.039) 28 TEH 0532052 DUP050033138 Table 5 Logarithmic and Median Data Summary for Individuals8 (continued) Subject & Period El E2 3 E4 P Diet (mg/day) 0.103/1.563 (0.108) 0.19772.511 (0.173) 0.131/1.403 (0.132) 0.104/1.600 (0.102) 0.124/1.622 (0.127) Feces (mg/sample) 0.197/1.807 (0.203) 0.199/1.910 (0.217) 0.189/2.223 (0.190) 0.194/2.104 (0.205) 0.204/2.109 (0.217) Urine (mg/day) 0.035/1.256 (0.034) 0.055/1.233 (0.057) 0.062/1.199 (0.062) 0,073/1.368 (0.077) 0.030/1.262 (0.031) Blood (mg/IOOg) 0.031/1.153 (0.032) 0.037/1.153 (0.038) 0.040/1.208 (0.043) 0.045/1.102 (0.046) 0.026/1.135 (0.026) JUS C E P *f 0.156/1.492 (0.151) 0.212/2.094 (0.208) 0.095/1.730 (0.091) 0,161/1.560 (0.160) 0.398/1.592 (0.406) 0.128/1.567 (0.132) 0.021/1.570 (0,020) 0.044/1.294 (0.044) 0.020/1.276 (0.020) 0.020/1.294 (0.020) 0.032/1.227 (0-032) 0.018/1.247 (0.018) ss c El E2 E3 E4 P2 E5 E6 E7 P2 E8 9 E10 Ell El 2 El 3 P3 0.121/1.841 (0.124) 0.135/1.837 (0.130) 0.178/1.841 (0.178) 0.076/0.569 (0.077) 0.147/2.767 (0.130) 0.163/1.422 (0.155) 0.199/2.871 (0.157) 0.132/1.754 (0.135) 0.216/2.582 (0.219) 0.195/2.000 (0.187) 0.103/2.032 (0.100) 0.146/1.807 (0.153) 0.177/1.714 (0.173) 0.136/1.879 (0.142) 0.177/1.820 (0.176) 0.234/1.914 (0.237) 0.363/2.133 (0.405) 0.195/1.923 (0.201) 0.194/1.875 (0.200) 0.294/1.675 (0.337) 0.166/2.075 (0.175) 0.215/1.928 (0.220) 0.241/1,828 (0.280) 0.440/1.811 (0.465) 0.265/1.607 (0.270) 0.254/1.633 (0.265) 0.203/1.742 (0,225) 0.193/1.603 (0.205) 0.275/1.652 (0.255) 0.271/1.700 (0.275) 0,194/0.302 (0.205) 0.267/1.700 (0.265) 0.182/1.867 (0.185) 0.396/1.614 (0.400) 0.024/1.288 (0.024) 0.024/1.256 (0.015) 0.026/1.333 (0.026) 0.022/1.358 (0.022) 0,026/1.285 (0.026) 0.025/1.667 (0,028) 0.034/1.288 (0.035) 0.027/1.445 (0,028) 0,034/1.303 (0.033) 0.030/1.233 (0.030) 0.023/1.294 (0.023) 0.026/1.334 (0.026) 0.033/1.271 (0.032) 0.034/1.340 (0.034) 0.032/1.538 (0.033) 0.036/1.413 (0.037) 0.036/1.276 (0.030) 0.018/1.156 (0.019) 0.019/1.194 (0.019) 0.019/1.343 (0.022) 0.018/1,127 (0.018) 0.019/1.189 (0.019) 0.017/1.288 (0.017) 0.022/1.159 (0.021) 0.024/1.086 (0.024) 0,023/1.227 (0.025) 0.021/1.096 (0.021) 0.024/1.142 (0.023) 0.020/1.256 (0.019) 0.027/1.107 (0.026) 0.026/1.122 (0.027) 0.026/1.183 (0.026) 0.028/1.205 (0.027) 0.021/1.096 (0.021) 29 Balance (mg/day) (-0.062) (0.013) (-0.002) (-0.038) (-0.056) (-0.012) (-0.191) (-0.024) (-0.091) (0.014) (0.061) (-0.032) (-0.032) (0.035) (0.062) (0.030) (0.060) (0.034) (0.006) (-0.005) (-0.008) (0.020) (0.032) (0.095) (0-034) TEH 0532053 DUP050033139 Table 5 Logarithmic and Median Data Summary for Individuals (continued) Subjects Period Diet (mg/day) Fecesb (mg/sample) Urine (mg/day) Blood (mg/IOOg) Balance (mg/day) SW c e p 0.178/1.567 (0.177) 0.498/1.211 (0.484) 0.299/3.170 (0.239) 0.233/1.667 (0.225) 0.486/1.618 (0.490) 0.360/1.574 (0.305) 0.037/1.466 (0.036) 0.040/1.449 (0.039) 0.028/1.324 (0.028) 0.039/1.253 (0.040) 0.038/1.219 (0.040) O.025/N=2 (0.025) (-0.023) (0.031) (-0.009) a Data shown as log mean/logSD over (median) except for balance, for which only the median is given. N's for these data are shown in Table 4. b Per sample (rjtther than per day). See text. 30 TEH 0532054 DUP050033140 TABLE 6 Fecal Evacuation Rate, Adjusted Fecal Lead Per Day, and Fecal Lead as Percent of Dietary Lead Subject and Period Evac. a Fecal Pb*5 Percent ofc Rate Per Day Diet (%) (ug/ug) (%/%) EB C E P 100 333/ 305 100/ 95 ioo 1880/1701 86/ 79 100 304/ 254 104/ 94 MB C E P 86 183/ 158 88/ 85 86 257/ 228 130/128 86 247/ 217 94/ 89 MOB C El PI E2 P2 60 182/ 157 86/ 86 57 179/ 146 95/ 95 57 212/ 168 122/114 60 233/ 207 199/223 67 125/ 115 100/117 PB C E P 55 119/ 107 89/ 87 47 122/ 101 106/ 95 33 175/ 132 130/131 SB C E P 93 102/ 88 95/100 81 135/ 113 124/133 90 109/ 101 133/160 FC C 99 198/ 163 63/ 78 E2 98 235/ 200 110/109 P2 100 140/ 127 88/ 86 E3 100 249/ 244 109/216 P3 100 138/ 119 100/ 98 LD C El E2 E3 E4 P 72 189/ 115 136/125 63 158/ 142 156/167 63 191/ 176 118/113 69 460/ 314 135/211 60 184/ 179 233/267 69 148/ 135 145/139 IF C E P 87 227/ 195 86 2808/2653 86 196/ 171 96/ 95 86/ 82 121/116 DH G El E2 E3 E4 P 52 172/ 126 177/142 71 133/ 124 439/144 57 100/ 100 103/114 65 151/ 119 145/163 65 124/ 110 175/164 51 133/ 94 168/132 31 TEH 0532055 DUP050033141 TABLE 6 Fecal Evacuation Bate, Adjusted Fecal Lead Per Day, and Fecal Lead as Percent of Dietary Lead (Continued) Subject and Period Evac. a Fecal Pb ^ Percent ofc Rate Per Day Diet (%) (ug/ug) (%/%) NK C El E2 E3 E4 PI E5 6 E7 P2 HR C El E2 E3 MR C E P JOS C El E2 E3 E4 P JUS C E P SS C El E2 E3 E4 PI 5 6 E7 P2 E8 E9 E10 Ell E12 El 3 P.3 TOO 200/ T74 TOO 165/ 144 TOO 160/ 145 100 153/ 149 100 208/ 131 TOO 147/ 145 100 126/ 115 100 146/ 135 TOO 146/ 140 100 123/ 104 42 130/ 116 43 121/ 118 41 132/ 127 41 155/ 144 83 425/ 345 85 1409/1280 68 319/ 275 49 116/ 88 61 113/ 124 66 118/ 143 54 124/ 103 60 121/ 123 71 127/ 154 83 148/ 133 80 364/ 325 76 117/ 103 92' 218/ 185 65 148/ 130 54 177/ 182 63 136/ 110 61 159/ 134 58 160/ 162 46 235/ 214 50 149/ 135 54 154/ 143 67 143/ 1.51 64 136/ 131 57 179/ 145 67 207/ 184 67 158/ 137 62 189/ 164 74 160/ 137 58 .266/ 232 142/140 98/105 114/118 101/103 138/124 109/107 103/111 49/ 49 107/115 55/ 52 83/ 80 141/164 203/223 189/187 163/144 106/ 99 135/131 104/ 95 95/115 62/ 83 90/ 78 104/121 91/121 88/ 88 167/156 106/113 149/149 90/100 82/102 155/143 107/103 98/105 106/136 96/100 70/ 81 58/ 81 103/131 105/ 95 100/106 96/ 96 89/ 93 55/ 58 58/ 57 32 TEH 0532056 DUP050033142 TABLE 6 Fscal Evacuation Rate, Adjusted Fecal Lead Per Day, and Fecal Lead as Percent of Dietary Lead (Continued) Subject and Period Evac. a Fecal Pb b Percent ofc Rate Per Day Diet (%) (ug/ug) (%/%) SW C E P 75 199/ 169 100/ 95 82 407/ 402 80/ 83 81 296/ 247 104/1Q3 % of days fecal samples were available compared to the number of days on collection. k Adjusted fecal lead (ug/day) expressed as mean/ median. Adjusted fecal lead as a percent of diet based on mean/median. 33 TEH 0532057 DUP050033143 Table 7 Urinary Lead Concentrations and Comparisons with 24 Hour Urinary Lead Excretion Subject and Period Arithmetic a Data (mg/liter) Log b & Median Data (mg/liter) Ratio 0 C 0.037/0.012 0.026/1.48 0.783/0.147 (0.010/0.050) (0.029) (0.400/1.176) E 0.046/0.029 0.091/1.365 (0.007/0.190) (0.090) PI 0.041/0.020 0.037/1.790 (0.007/0.130) (0.039) P2 0.021/0.017 0.012/3.266 (0.002/0.050) (0.025) MB G ^ 0.034/0.007 0.033/1.216 1.153/1.406 (0.020/0.060) (0.033) (0.606/9.756) E 0.065/0.011 0.064/1.186 (0.040/0.090) (0.064) P 0.043/0.042 0:044/1.262 (0.010/0.300) (0.036) MOB C El PI E2 Corn PCorn P 0.030/0.007 0.030/1.770 (0.020/0.050) (0.029) 0.053/0.012 0.052/1.265 (0.020/0.0S0) (0.052) 0.041/0.015 0,040/1.837 (0.020/0.100) (0.039) 0.050/0.012 0.048/1.288 (0.020/0.090) (0.049) 0.216/0.046 0,206/1.256 (0.130/0.290) (0.215) 0.032/0.008 0.031/1.300 (0.015/0.060) (0.030) 0.028/0.022 0.035/4.819 (0.010/0.200) (0.026) 1.020/0.832 (0.456/10.000) PB C E P 0.025/0.010 (0.008/0,062) 0.029/0.011 (0.0O8/O.O6O) 0.026/0.011 (0.009/0,050) 0.014/1.409 (0.014) 0,027/1.585 (0.026) 0.024/1.600 (0.023) 0.629/0.204 (0.258/1.471) SB C E P 0.026/0.007 (0.015/0.050) 0.052/0.016 (0.015/0.102) 0.027/0.008 (0.010/0.052) 0.025/1.330 (0.030) 0.049/1.419 (0.052) 0.026/1.489 (0.027) 1.133/0.306 (0.625/3.000) FC C El PI E2 P2 E3 P3 0.023/0.016 (0.010/0.300) 0.039/0.014 (0.030/0.070) 0.034/0.008 (0.020/0.050) 0.098/0.030 (0.030/0.230) 0.027/0.012 (0.010/0.090) 0.087/0.019 (0.040/0.150) 0.027/0.009 (0.010/0.050) 0.021/1.552 (0.021) 0.037/1.352 (0.034) 0.033/1.259 (0.033) 0.099/2.018 (0.094) 0,027/2.805 (0.025) 0.085/1.274 (0.086) 0.025/1.349 (0.027) 1.071/0.696 (0.282/12.500) Subject and Period Arithmetic a Data (mg/llter) Log b & Median Data (mg/liter) Ratio c LD C El E2 E3 E4 P 0.020/0.007 0.019/2.051 (0.005/0.042) (0.019) 0.0371/0.010 (0.015/0.064) (0.037) 0.000/0.012 0.059/1.242 (0.031/0.086) (0.059) 0.085/0.023 0.082/1.294 (0.050/0.158) (0.080) 0.082/0.016 0.081/1.225 (0.048/0.126) (0.083) 0.030/0.007 0.030/1.247 (0.018/0.049) (0.030) 1.098/0.308 (0.467/3.556) IF C E P 0.030/0.013 (0.010/0.080) 0.070/0.017 (0.040/0.110) 0.034/0.012 (0.010/0.065) 0.030/2.051 (0.026) 0.068/1.264 (0.065) 0.032/1.462 (0.025) 1.033/0.293 (0.319/2.929) DH C El E2 E3 E4 P 0,026/0.008 (0.009/0.056) 0.023/0.006 (0.013/0.042) 0.024/0.009 (0.011/0.044) 0.027/0.007 (0.014/0.052) 0.027/0.009 (0.011/0,046) 0.023/0.006 (0.013/0.036) 0.025/1.365 (0.033) 0,022/1.297 (0.024) 0.023/1.449 (0.022) 0.026/1.312 (0,026) 0.025/1.429 (0.027) 0.022/1.291 (0.022) 0.585/0.150 (0.413/1.436) NK C El E2 E3 E4 Pi 5 E6 E7 P2 0.023/0.005 0.022/1.282 (0.007/0.036) (0,022) 0.027/0.006 0.026/1.315 (0.006/0.040) (0.026) 0.027/0.005 0.027/1.219 (0.014/0.045) (0.028) 0.028/0.005 0.027/1.197 (0.015/0.038) (0.029) 0.035/0.005 0.034/1.164 (0.026/0.050) (0.034) 0.032/6.003 0.032/1.091 (0.028/0.036) (0.032) 0.034/0.007 0.033/1.216 (0.024/0.057) (0.032) 0.039/0.007 0.038/1.213 (0.027/0.064) (0.038) 0.036/0.006 0.035/1.175 (0.023/0.053) (0.035) 0.033/0.008 0.032/1.250 (0.020/0.057) (0.032) 0.833/0.109 (0.526/1.125) HR C El E2 0.026/0.009 (0.009/0.051) 0.021/0.006 (0.008/0.039) 6.024/0.007 0.026/2.084 (0.025) 0.020/1.346 (0.021) 0.023/1.400 1.143/0.708 (0.265/6.333) 34 TEH 0532058 DUP050033144 Table 7 Urinary Lead Concentrations and Comparisons with 24 Hour Urinary Lead Excretion (Continued) Subject and Period E3 C DC1 PDC1 DC2 PDC2 DC3 PDC3 DC4 DC5 PDC5 DC6 POC6 DCT PDC7 P C El E2 E3 E4 P Arithmetic a Data (mg/liter) Log b & Median Data (mg/liter) (0.008/0.040) (0.024) 0.026/0.01 0.024/1.539 (0.007/0.050) (0.024) Ratio 0.016/0,012 0.018/5.408 (0.010/0.050) (0.011) 0.055/0.018 0.053/1.435 (0,010/0.140) (0.055) 0,037/0-011 0.036/1.361 (0.025/0.055) (0.032) 0.057/0.016 0.055/1.321 (0.035/0-095) (0.054) 0.072/0.027 0.068/1.403 (0,035/0.150) (0.066) 0.067/0.015 0.065/1.282 (0.040/0.035) (0.071) 0.054/Q.01S5 0.052/1.346 (0,030/0.075) (0.054) 0.073/0.033 0.066/1.641 (0.030/0.160) (0.067) 0,069/0.013 0.067/1.265 (0.045/0.100) (0.068) 0.071/0.014 0.069/1.233 (0.050/0.095) (0.072) 0.083/0.017 0.082/1.213 (0.060/0.130) (0.081) 0.075/0,013 0.074/1.202 (0.050/0.095) (0.075) .0.095/0.028 0.144/6.252 (0.050/0.130) (0.097) 0.067/0,017 0.065/1.321 (0.040/0.085) (0.072) 0.073/0.029 0,067/1.600 (0.020/0.150) (0.072) 0.040/0.016 0.037/1,521 (0.010/0.120) (0,040) 0.884/1.274 (0.333/7.500) 0.019/0.005 (0,007/0.037) 0.034/0.007 (0.019/0.052) 0.060/0.013 (0.039/0.093) 0.063/0.012 (0.040/0.095) 0.082/0.013 (0,051/0,102) 0.034/0.007 (0.013/0.051) 0.019/1.683 (0.019) 0.033/1.260 (0.034) 0.058/1.245 (0.059) 0.062/1.208 (0.063) 0.081/1.189 (0.084) 0,030/1.247 (0.034) 0.955/0.178 (0.571/1.733) Subject and Period JUS C E P SS c El E2 E3 E4 PI E5 E6 E7 P2 E8 E9 E10 Ell E12 El 3 P3 SW C E P Arithmetic Data (mg/liter) Log b & Median Data (mg/liter) Ratio 0 0.020/0.009 (0.010/0.040) 0.041/0.012 (0.010/0.080) 0.016/0.003 (0.015/0.030) 0.019/1.968 (0.020) 0.040/1.552 (0.040) 0.016/1.618 (0.015) 0.912/0.400 (0.303/2.143) 0.023/0,004 (0.014/0.036) 0.025/0.005 (0.012/0.039) 0.029/0.007 (0.012/0.046) 0.023/0.005 (0.014/0.035) 0.026/0.006 (0.014/0.044) 0.025/0.008 (0.012/0.039) 0.033/0.009 (0.019/0.059) 0.027/0.007 (0.010/0.049) 0.034/0.007 (0.018/0.053) 0.031/0.006 (0.019/0.046) 0.022/0.005 (0.012/0.032) 0.026/0.009 (0.007/0.055) 0.029/0.007 (0.012/0.045) 0.031/0.007 (0.018/0.048) 0.035/0.010 (0.017/0.057) 0,031/0.007 (0.013/0.045) 0.035/0.007 (0.025/0.046) 0.022/1.208 (0.022) 0.027/2.535 (0.025) 0.026/1.315 (0.030) 0.022/1.245 (0.022) 0.025/1.262 (0.024) 0.024/1.429 (0.024) 0.032/1.288 (0.033) 0.026/1.309 (0.027) 0.033/1.250 (0.034) 0.030/1.197 (0.030) 0.022/1.239 (0.022) 0.024/1.406 (0.024) 0.029/1.294 (0.030) 0.030/1.250 (0.030) 0,034/1.343 (0.036) 0.030/1.274 (0.032) 0.035/1.242 (0.035) 0.962/0.256 (0.588/2.375) 0,028/0.011 (0.010/0.075) 0.027/0.009 (0.010/0.060) 0.021/0.003 (0.010/0.030) 0.027/1.738 (0.025) 0.029/2.586 (0.025) 0.020/1.180 (0,020) 0.761/0.232 (0.328/1.638) Mean/SD over (mlnlmum/maximum). c Logarithmic mean/SD over (median). The data refer to the ratios of the urinary concentrations (mg/llter) over the daily urinary lead excretion (mg/day). Shown are the mean/SD over the minimum and maximum values In parenthesis for the control period data only. to a 35 TEH 0532059 DUP050033145 Table 8 Coefficients of Variation for Subject Control Periods By Year9 Date Subject 1937 1939 1941 1943 1950 1951 1955 1957 1959 1960 1960 1963 1963 1966 1967 1970 MR EB IF SW MOB FC MB JUS SB LD ^io s NK SS HR DH PB Diet (%) 56 42 50 52 41 50 33 44 75 132 54 50 66 61 60 44 Feces (%) 67 52 60 52 68 60 54 47 54 282 77 48 60 55 78 58 Urine (%) 50 32 50 40 26 36 18 46 29 37 25 22 24 37 27 40 Urine Cone. <%) 8 32 43 39 23 70 21 45 27 35 26 22 17 35 35 40 Blood (%) 28 19 26 23 35 27 21 24 14 28 19 15 16 14 20 17 Overall av 57 73 34 32 22 Balance (%) 399 1152 850 632 7633 638 953 5850 413 923 1820 118 220 924 227 1658 1526 9 Coefficients of variation = standard deviation/mean x 100%. 36 TEH 0532060 DUP050033146 Table 9 Coefficients of Variation a for Inhalation Exposure Conditions and Pulminary Deposition Conditions Date Subject and Period 1950 1951 MOB PC 1955 MB 1957 JUS it 1959 SB 1960 LD 1960 JOS 1963 NK 1963 SS 1966 MR 1 2 1 2 3 1 1 1 1 2 3 4 1 2 3 4 1 2 3 4 5 6 7 1 2 3 4 5 6 7 8 9 10 11 12 13 1 2 3 Concentration (%) 16 18 64 10 44 18 23 10 14 9 9 8 7 8 7 7 11 10 20 10 10 11 20 20 20 10 10 22 10 20 10 2 20 16 16 17 10 15 10 Hours/Day (%) 9 0 8 3 7 9 0 35 0 0 3 6 0 0 3 4 0 0 0 6 1 7 2 0 0 6 0 9 6 0 14 8 7 1 6 7 14 6 7 Deposition (%> 37 21 2 28 31 15 16 15 10 26 10 9 13 19 21 13 20 30 10 26 30 7 9 22 27 30 35 11 15 26 12 28 12 12 19 30 8 6 39 Respiration Rate (%) 30 22 11 18 11 3 10 12 9 11 5 11 7 7 7 3 3 5 5 5 10 11 7 7 7 14 17 10 13 9 9 7 4 7 7 7 7 9 37 TEH 0532061 DUP050033147 Tables Coefficients of Variation for Inhalation Exposure Conditions and Pulmlnary Deposition Conditions (continued) Date 1967 1970 Subject. and Period DH 1 2 3 4 PB 1 Concentration (%) 14 14 15 38 42 Hours/Day (%) T1 5 8 10 10 Deposition . (%) 29 37 11 35 32 Overall av 16 5 22 Respiration Rate (%) 8 9 9 12 14 9 a Coefficient of Variation = standard deviation/mean x 100%. i.* 38 TEH 0532062 DUP050033148 Year 1937 1939 1941 1943 1950 1951 1955 1957 1959 1960 1960 1963 1963 1966 1967 1970 Table 10 Selected Correlation Coefficients Between Various Parameters For Control Periods According To Year Subject B/U B/D B/BAL U/D U/BAL MR EB IF SW MOB FC MB JUS SB UD JOS NK SS HR DH PB -0.36 -0.24 -0.01 0.22 0.23 0.34 a 0.23 -0.14 0.38 0.32 a 0.10 0.45 a -0.30 -0.04 0.02 -0.26 0.83b -0.63 -0.10 -0.12 -0.09 0.03 0.32 0.14 -0.06 0.08 -0.13 0.21 -0.07 0.31 -0.08 -0.16 0.74 0.40 -0.04 0.0 -0.31 -0.02 -0.41 0.37 -0.08 -0.05 0.06 0.04 0.02 0.04 -0.16 -0.01 .-0.13 0.0 -0.01 0.10 -0.02 0.14 0.06 0.01 0.0 0.03 -0.06 0.12 0.12 -0.06 0,25 0.18a -0.19 0.06 -0.10 -0.02 -0.06 0.02 -OAl -0.18 -0.08 -0.14 a -0.07 0.03 0.13 0.10 -0.26 -o.oi D/F -0.09 0.04 0.29* 0.09, 0.14' 0.21 * 0.82* 0.26' 0.111 0.32* 0.04 0.16 -0.01 -0.05, 0.15 0.06 ap<0.01 bp<0.05 TEH 0532063 DUP050033149 Table 11 Selected Correlation Coefficients Between Various Parameters For Combined Exposure and Post Exposure Periods Subject txposure Rate B/U B/D B/BAL U/D U/BAL <9 /Day) SW 300 MR 1000 EB 2000 IF 3000 (ug/m3) 0.32a 0.10 0.24 a 0.18 Oral Experiments 0.34 0.06 0.26 0.01 -0.08 -0.09 0.03 0.05 Inhalation Experiments0 0.05 0.17 0.63 0.58 -0.11 -0.06 0.06 0.10 NK SS HR DH JOS LD MOB SB JUS PB MB FC ^ 2.4 3.7 4.5 7.3 22.8 23.0 25,4 27.4 28.1 28.4 29.4 30.4 0.33 0.23a -0.07 -0.12 0.67 a 0.64 a 0.37 a 0.42 a -0.42 0.36 b 0.53 0.68 a -0.01 0.11 -0.16 -0.13 0.08 0.18b 0.19 -0.03 0.06 0.32 b -0.23 0.14 -0.09 0.03 0.05 -0.14 -0,04 -0.10 -0.15 -0.05 0.20 0.10 -0.34 -0.22 0.08 0.21 -0.04 0.01 0.0 0.17 0.30 0,14 0.28 -0,02 -0.08 0.15 -0.06b 0.05 -0.08 -0.13 -0.13 -0.12 -0.05 -0.10 -0.33 -0.11 -0.21 -0.26 D/F o.ii,, 0.34 0.74a 0.82 -0.30 0.02 0.22 -0.04 -0.04 0.37 0.37 0,29 0.30 -0.12 0.15 0.19 ap<0.01 bp<0.05 cExposure rates for subjects who participated in more than one exposure period (See Table 12) have been averaged. TEH 0532064 DUP050033150 Subject & Period SW MR EB IF Table 12 Dose Response Summary for Oral and Inhalation Experiments Differences from the Control8 Exposure Rate Diet ug/day Feces ug/day Oral Experiments Urine ug/day Blood ug/IOOg (ug/day) 300 1000 2000 3000 308 1072 1848 2981 208 984 1547 2581 3 55 80 49 -1 17 33 19 Balance ug/day 59 175 209 395 NK SS NK SS SS NK SS SS HR NK SS SS NK SS NK HR NK SS SS DH SS SS SS DH HR DH DH LO JOS JOS LD MOB LD (ug/m3) 13 1 00.6 1 00.6 2 1.2 2 1.2 3 1.8 3 1.9 8 2.4 4 2.4 1 2.4 4 2.4 5 2,7 9 3.2 5 3.3 6 3.4 6 3.6 2 3.7 7 4.0 7 4.3 10 5.4 1 5.6 11 6.2 12 7.0 13 7.2 2 7.3 3 7.5 3 7.6 4 8.8 1 9.3 1 9.4 2 19.3 2 19.7 1 22.4 3 27.1 Inhalation Experiments 27 18 -1 71 -58 10 - 14 3 -70 10 53 25 - 19 10 157 - 91 -4 73 60 -1 18 67 144 0 - 74 7 - 26 - 38 7 79 23 - 23 201 - 35 - 70 - 40 - 41 - 82 - 47 - 82 24 - 59 8 17 - 39 - 74 - 69 - 54 11 - 54 - 64 - 11 - 39 - 60 - 29 - 58 - 72 28 - 21 - 46 - 31 36 55 2 -8 271 4 0 3 2 -2 5 -1 2 -2 10 10 2 10 4 18 0 11 10 8 1 10 10 13 -5 9 2 0 18 15 37 37 25 67 0 1 1 1 -1 3 5 0 4 6 4 2 6 5 10 0 9 5 8 1 7 7 10 -4 6 -1 -2 11 11 16 IS 13 22 76 79 30 87 2 48 83 54 - 78 -7 47 64 42 88 192 -120 40 136 80 32 91 116 189 0 -119 9 4 - 48 - 48 -4 10 - 43 -132 TEH 0532065 DUP050033151 Subject & Period Table 12 Dose Response Summary for Oral and Inhalation Experiments (continued) Differences from the Control8 Exposure Rate Diet ug/day Feces ug/day Urine ug/day Blood ug/IOOg Balance ug/day JOS 3 SB JUS PB MOB 2 MB FC 3 FC JOS 4 * LD 4 FC 1c 27.1 27.4 28.1 28.4 28.4 29.4 30.1 30.6 35.2 35.9 84.8 26 2 49 - 19 - 94 - 12 -no - 25 4 - 60 - 56 15 33 192 3 51 74 51 37 5 -5 - 73 43 20 - 52 27 11 - 57 21 11 -173 11 10 - 27 20 6 -272 38 16 -123 49 9 -213 54 17 -116 56 25 -100 67 23 -142 2 -2 15 ^Experimental means minus the control means. b Inhalation exposure rates expressed as average daily concentrations calculated over the whole exposure period- See text. c Excluded from other calculations because data represent only 9 days of exposure. 42 TEH 0532066 Subject SW MR EB IF table 13 Post Exposure Summary for Oral and Inhalation Experiments Differences from the Controla Exposure Rate Diet (ug/day) Feces (cg/day) Urine (ug/day) Blood (ug/IOOg) Oral Experiments {ug/day) 300 85 97 -11 1000 -25 -106 31 2000 -41 -29 15 3000 -75 -31 4 -15 5 7 13 Balance (ug/day) 1 68 -41 -45 NK SS HRC DH JOS LD MOB SB JUS PB MB FC (ug/m3) 2.4 3.7 4.5 7.3 22.8 23.0 25.4 27.4 28.1 28.4 29.4 30.4 Inhalation Experiments0 82 314 - 18 27 - 37 - 86 - 25 - 59 0 55 -100 - 77 48 - 39 11 - 54 - 57 -4 - 31 130 64 - 60 9 12 -10 11 9 -5 0 -4 9 7 0 3 148 17 260 - 3 37 6 - 53 5 -5 - 4 - 25 - 1 - 23 - 2 - 25 9 - 68 4 -9 -1 1 a Differences - Post Exposure means - Control means. bExposure rates for subjects who participated in more than one exposure period (see Table 12) have been averaged. CHR had no post exposure period. <f ^!t TEH 0532067 DUP050033153 Table 14 Parameter Correlation Coefficients For Inhalation Exposures Exposure Bate Ail Exposures Lower Exposures b Higher Exposures0 Diet All Exposures8 Lower Exposures13 Higher Exposures0 vs. vs. Feces 0.60 d 0.11 -0.05 Feces 0.19 -0.11 0.68 d Urine 0.85 d 0.36 0.43 Urine 0.11 0.46 0.24 Blood 0.78 d 0.32 0.26 Blood 0.20 0.35 0.46 n = 43 bLess than 10 ug PB/m3, n = 29. Greater than 10 ug Pb/m3, n = 14. dp<0.01 ep<0.05 Balance -0.72 d -0.21 -0.53 Balance 0.55 d 0.88 d 0.38 44 TEH 0532068 DUP050033154 Diet (ug/day) Control 181 Averages Dietary Supplementation (ug/day) 50 100 200 500 1000 2CQ0 231 281 381 681 IlSf 2181 Airborne Supplementation (ug/m3) 1 2 5 10 35.7 Table 15 Overall Responses to Oral and Inhalation Exposures Feces (ug/day) Urine (ug/day) Blood (ug/IOOg) 196 29 25 BalanOe (ug/day) -32 41.6(238) 83.3(279) 166.6(363) 416.5(612) 833.0(929) 1666.0(1862) Responses to Oral Supplementation13 2.2(31) 4.5(34) 9.0(38) 22.5(52) 45.0(74) 90.0(119) 0.8(26) 1.7(27) 3.4(28) 8.5(34) 17.0(42) 34.0(59) Responses to Airborne Supplementation 6,6.(-25) 13.3(-19) 26.6(- 5) 66.5(+34) 133.0(+101) 266.0(+234) 1.5(198) 2.9(199) 7.4(203) 14.7(211) 52 (248) 1.4(30) 2.8(32) 7.0(36) 14.1(43) 50.3(79) 0,6(26) 1.1(26) 2.8(28) 5.7(31) 20,3(45) - 3.3(- 35) - 6.6(- 39) - 16.6(- 49) - 33.2(- 65) --11 S.S(--150) aShown are the expected parameter increases over control levels based on overall regression curves. The in creases plus control levels are shown In parenthesis. b Regression coefficients == 0.83, 0.045, 0.017, and 0.133 for feces, urine, blood and balance respectively. c Regression coefficients - 1.47,1.41, 0.57, and -3.32 for feces, urine, blood and balance respectively. 45 TEH 0532069 DUP050033155 TIME COURSE OF INDIVIDUAL EXPERIMENTS Figure 1, tim e Course of Individual Experiments. n LU "3 CD S3 CO 2o b- (M 3 < 2 2 0> 0> 0> 'f CO aOt N <a00)t L_J err O 2 rs o <^ q: 2 O4 cc 2 I<0O0^ CO " O* uj S ~3 ~ Cr>D k>- COv 1<n0 Z 2& b- .2 <- < X 2- 3 46 TEH 0532070 DUP050033156 47 TEH 0532071 DUP050033157 Figure 2. Expected Experimental Responses, S U B J E C T - SW Figure 3A. Date Plots for Individual Subjects with Time. 0 .0 0 o o * o CO o CM CsJ . o CD .* o oo o CO CD CSJ -O O) o I'd* oo oo o CD o CD O T o CM oo o --* CO o CD CD -dO CsJ O oo 03 O CD CD o N o o o o o 1 i i CSJ o O O'-* o O O o oo o O o o oo o o O o o AUO/0d m ABO/Sd O'W ABG/a-d OU Atf0/8d QW MOOCH/Bd 0U TEH 0532072 DUP050033158 > SUBJECT- MR Figure 3B. Data Plots for Individual Subjects with Time. ooo o o o CP CD CTO CD CD O O oo o O o a o 00 CD o CM 't CD CO oo OO CM CD CO 1 o --1 cn . > * ' o i 1 i m- CO CM *- o oco CSI o Aua/ad ow AUCI/8 d ow Auo/ad OW o OO o o ABQ/Er) QW oo CO CD ^|- CM o O-* O O O O O oo O CD CD O o WOOOI/0d 0M 49 TEH 0532073 DUP050033159 cOr UJ s 50 TEH 0532074 DUP050033160 SUBJECT- EB Figure 3C. Data Plots for individual Subjects with Time. SUadECT- I f Figure 3D. Data Plots for Individual Subjects with Time. 1 \ m >CE- O UJ AbQ/9cJ 9.W AtiQ/ad ow AUt3/8d W AtiQ/8d OW MO.O.OI/8d OW 3 TEH 0532075 DUP050033161 MG PB/ORY MG PB/DRY MO PB/DRY MO PB/DRY SUBJECT- NK Figure 3E. Data Plots tor Individual Subjects with Time. 52 TEH 0532076 DUP050033162 MO P B /1ODOM f| 1|| i 53 TEH 0532077 DUP050033163 SUBJECT- SS Figure 3F. Data Plots for Individual Subjects with Time. co <x a 54 TEH 0532078 DUP050033164 Figure 3G. Data Plots for Individual Subjects with Time. BALANCE Figure 3H. Data Plots for Individual Subjects with tim e. TEH 0532079 DUP050033165 56 TEH 0532080 DUP050033166 SUBJECT- Figure 31. Data Plots for Individual Subjects with Time. MG PB/DRY MG PB/DRY MG PB/ORY MG PB/DRY SUBJECT- JGS Figure 3J. Data Plots for Individual Subjects with Time. TEH 0532081 DUP050033167 MG PB/100GM SUBJECT- MOB TIME I DAYS) AUQ/8d 3W AH.O/ad OW AHO/ad OM AUO/ad sw W00Ql/8d CH4 I E x 0 eo o *CD ko. O*0-9 CL +C-O* Q CO u3o> 4- i ,| 4 58 TEH 0532082 I J DUP050033168 w!KP.*SS -> SUBJECT- Figure 3L. Data Plots for Individual Subjects with Time, *1961 130 ~*t9Sl JW~ 1961 ajti ww io96i ns~ ra ><x. CD U5DJ CVOJ Ti9GI HdU 3 TiSEfTIBr- "Ss6i J.no sssnnr1 SsrpsdH- O CM 0 CD CM OO O O CO 0 CO 0 Tj- 0 CM OO OO O CD O CD O O CM OO 0-- CO 0 CO 00 CM O OO O---' CO 0 CD O O CM O O O . O O --> CD O .1 1 1 0 0 0 CO O -- O a O O OO 0 0 0 O OO 0 O O O O AUQ/8J 3W AB0/8J OKI AHO/ad OU AbQ/S.d 9W U0001/8d OW 3 TEH 0532083 DUP050033169 ! ^96i adb "1561' "W *196i adb Ji95i Nar d CD >- aO: 3 0 t st hw SUBJECT- SB `13961 iOT 1396 rw 3 ""sssTTJQ" ""6S61 W 1 J CO s3o> U- '6S51 iJda OO O .r-i *CD O o O CM -CM o? OI OCD oI oO g g gg g S 2 2 g'M- CM CD 0.0 co to m. CM O^- O O CD CD '*3- CM Oo o o O O CD-* CD CD CD O oo o o o O Oo o O o O O Auo/ad on At)a/ad aw AUa/8d ow AUC/8d ow usocn/ad ou I 3 TEH 0532083 DUP050033170 oCE 60 TEH 0532084 .J DUP050033171 SUBJECT- JUS Figure 3M. Data Plots for Individual Subjects with Time. flfl.LLMC j TEH 0532085 DUP050033172 SUBJECT- Figure 30. Data Plots for individual Subjects with Time. o U3 ABG/9d 3U AB0/9d 3U AU0/9d OU AUB/Sd OW WOOD 1/8d W 62 TEH 0532086 DUP050033173 MG PB/DRY BRLRNCE SUBJECT- FC -1 .00 -----------*-------*-- ---....................................... .. + -- * * t Ti A V V v 1# jSUffc 0.00 nTFT " 1 .00 ' 1 1- t. MStfitiiift i'Hfe* -JL ** i 1 sfcfe/.... MS PB/DRY MS PB/DRY MG PB/DRY MS P3/100GM TJME(DRYS) Figure 3P. Data Plots for Individual Subjects with Time. 63 TEH 0532087 DUP050033174 YEAR 1930 B40 090 .I960 1970 j YEAR | Figure 4. Control Period Means for Each Subject by Year of Experiment j 64 TEH 0532088 DUP050033175 A BALANCE, B DIET ------- 'f FECES ,3a. I9J0 940 lew 960 1970 YEAR URINE-------* BLOOD------- Figure 5. Standard Deviations for Each Control Period by Year of Experiment. 65 TEH 0532089 DUP050033176 FECES (jJG P B / DAY) URINE OR BALANCE (p G P B / DAY) BLOOD(pG PB/IOOG) Figure 6. Response Data for Lead Balance and Fecal, Dietary, Urinary and Blood Lead for Oral Supplementation Experiments. TEH 0532090 DUP050033177 BALANCE EXPOSURE RATE (jJ G /fv !3} Figure 7A. Response data for lead balance for the inhalation experiments shown as a function of adjus 0 Aexposure rates and particle size. Particle sizes are designated as ,0.05 um; +, 0.11 urn; , 0.75 um; 0 , 0 . 9 0 um; and <> ,1.20 urn. DUP050033178 FECES (Ava/orl) ad ivoad 68 TEH 0532092 DUP050033179 (EXPOSURE RATE JJG/M ) Figure 7B. Response data tor fecal lead for the inhalation experiments shown as a function of ad A , Aexposure rates and particle size. Particle sizes are designated as . 0.05 um; +, 0.11 urn; 0.75 um; 0 , 0 . 9 0 urn; and , 1.20 urn. DIET (a v q /d H) ad i3ia 69 T> jm3 S' c e3o E3 --o to eg 09 "S ll<$> a 3 -a 1* |26 5 O x (3 S8'-8*s ^o_ CM ! Ll J 5 ji t! c 1- i !-- < VC . ? o. slo UJ cc 3 . CO ** j= 5-0 I cn O 6 j: H fMfi _ i +CL a >< In. UJ 5 I| <5 2 8 ' o to co 0 8- ds. 3 CD TEH 0532093 DUP050033180 DIET (Ava/orl) ad laia 69 I sS%T 40 S co oE 33 *- 0 CO CO CM <<00 **o *"- cI S!<$> j= S'-c. w gE & -O * |E <3 o O &j3 8*. CM ! LU l(0i0eL t l-- . p < f IS DC is; *# UJ n S .i DC 3 CO ffl - -g 3 O !|5 Cl a g + X LU o 2 tr -- 3 5= .3 o 811O o. 0 S 1 2 .J33L.', TEH 0532093 DUP050033181 <5 <k Q URINE * ( a v o / orl) ad 3Nian 70 XJ B iOo o ro wS o LU ,, bs SK U1 O' ri o) O a. X UJ Qf=g>i LL. TEH 0532094 DUP050033182 Ui ( 9001/90) 8d 00018 , 71 - BLOOD EXPOSURE RATE ( pG/M3} Figure 7E. Response data for blood lead for the Inhalation experiments shown as a function of a exposure rates and particle size. Particle sizes are designated as A O . 0.05 um; +, 0.11 um; , 0.75 um; , 0.09 urn; and <$> , 1.20 urn. oro o 04 O TEH 0532095 DUP050033183 -- - Aj* - ________ ...... ....... ---- _----- ----- --------- - --------n ?< ----------- ------------- 1 " K, '1-- fV __ -- 1 $ -- ion..n:inmn.i inwoomroMM. ________ T -- -------- ---- -- t= r-mnr.-n.-i*,mj t -iv v A______1_________ \ I ------- --- pi ------- r 4- s-- i------------ [V . j ------- 4 --------i i: ----------- ~ . ._ ,, V .. . . t ------------- A1 ,, _ JLr ------- -- _ /1 / ----- -------- _______AZ_____ V \ I p --i ________ -- ------- --------\ft -H /--1 I-------------j -- A=v ------If !_____ i i ----- -4 cm. _______1 1/1 f \ L \\L $ _____ __ ~t ____ i -- *------- ----_ - " -n,s....... "_u...nnimi r- ---- ***" -- -- ,uil i im1 ---------- 1 A ____ i A| . --t Z_| -- ft -- --1 --f ...... -- .. 1,_,- --, . -- IW**TM**4m" mm------, T =IKT51ittlTlc trim's tniflti nn, Ir ic. ro . CD Madisoi i Ave.. N 3w York 10017. l _--m--m -- --* . ,. ,,,... . ,-.. 1T|,.1, ______ -- . r.J,,.r,r.nr-r.., ,,v. _3 ______ .......... __,L,,,,,,,, -- --*: l..,J.-_.,rrT..nT_... 1--- - -- ______ ~l ....... ........ -- :::::: ______ ------------- mm--*.--* --mm----. --p^- TTTTD'Tn U.S.A. --- --* -- mm --1-- mwmm mm _ HMggggg BBHlia warn DUP050033184