Document LJewJ5MMYrm06ZzBVNdYzzXn7

: eitremn ne foe ee ra es we a . Reprinted fro ." INHALED PARTICLES IV Edited by W. H. WALTON . PERGAMON PRESS OXFORD AND NEW YORK 1977 i ;: a ' ot t , . RAER RIT ITI Reha tI IE I , OEIC a tA, - DEES SOUS Sete Obst Mon - Zo , .tw . ry 5 0052387 JNJ 000343160 Ed Cosmet Tavirol Vol 17 pp 117 to 122 Pergamon Press Lid 1979. Printed in Great Britain THE DETERMINATION OF RESPIRABLE _ PARTICLES IN TALCUM POWDER R. S. RUSSELL R. D. MERZ W. T. Sherman and J. N. SiveRTSON Johnson & Johnson Baby Products Company U.S. Route 202 Raritan uo NJ 08869 USA Received 15 September 1978 Abstract mass concentrations of potentially respirable particles produced during routine application of talcum powder were determined Tests were conducted both on adults exposed to tale over 7. the whole body area and infants exposed in the napkin area The total exposure time the amount of powder used and the average tale concentration in the air in the region of the nares were measured These average tale concentrations were compared with the threshold limit value TLV whichis con'. sidered safe for industrial tale workers and also with chronic exposure levels for experimentally exposed hamstersin which no adverse reactions were seen The average adult exposure was 600 times less than the TLV and 500 times less than the level at which noadverse effects were seen in chronically exposed hamsters Likewise the average infant exposure was over 2000 times less than the TLV and over 1800 times less than the hamster effect level INTRODUCTION When finely divided powder is dispensed from a container with a sprinkle cap airborne particles . are formed in the environment of the user Some will be respirable particles but they will be at a relatively low concentration and exposure will be of short duration because of settling and dispersion One . example is the particles produced during the normal use of baby or body talcum powders The mass concentration of respirable particles pro- duced during the powdering of baby or an adult cannot be effectively measured with standard dustsampling equipment which is used to accumulate and sample particles from more stable atmospheric areas such as mines or factories Ayer Sutton & . Davis 1968 Cochrane 1972 Lippmann 1970 The short duration and low concentration of particles produced during a single application of talcum powder poses problems and one purpose of this study was to design both the method and equipment needed to overcome these problems A respirable particle has the potential to reach and be deposited in the lung The probability of this occurring depends upon the aerodynamic equivalent diameter AED of the particle The AED of a particle is defined as the diameter of a unit density sphere having the same aerodynamic qualities as the particle in question In this study a respirable particle was defined as having an AED of 10 mor less Ettinger Partridge & Royer 1970 Seltzer Bernaski & Lynch 1971 A second objective of this study was to compare the average talc exposure of infants and adults to two quite different published acceptable levels of talc inhalation Firstly the data was compared to 3 mg the permitted threshold limit value weighted average TWA as listed by the American Conference of Governmental Industrial Hygienists 1977 Secondly the average tale exposures were compared to the respirable tale concentration of 8 mg reported by Wehner et al Wehner Zwicker & Cannon 1977a in an inhalation study at which no adverse reactions were seen in chronically exposed hamsters The TWA cited above is the weighted average concentration for a normal hr working day in a 40 working week to which industrial workers may be exposed safely EXPERIMENTAL Equipment Two pieces of specialized equipment were required to measure the respirable particle.com- particle.com- . centration A prefilter to simulate the human respiratory tract by dividing the talc into respirable and nonrespirable particle fractions was needed A massmonitoring device to remove the respirable particles from the air stream and weigh them in a very short time interval was also essential A mm nylon cyclone was used to simulate the particle fractionation system of the human respiratory system Caplan Doemeny & Sorenson 1977 Seltzer et al 1971 The percentage of particles that can penetrate into the lung increases with decreasing aerodynamic equivalent diameter until other physical factors take effect and the percentage penetration reaches a plateau The American Conference of Governmental Indus- trial Hygienists and the AEC Los Alamos Scientific Laboratory have established a standard respirable | dust size fractionation curve Ettinger et al 1970 Seltzer et al 1971 Investigators have shown that the 10mm nylon cyclone operating at 1-7 litres flow rate has a collection efficiency for respirable particles -which matches this standard Caplan et al 1977 Seltzer et al 1971 The nature of this study required mass measurement of respirable powder in quantities as low as 01 gin a relatively short time span sometimes as low as sec The Thermo Systems Inc. TSI St Paul MN crystal mass monitor Model 3210A designed for general particle monitoring appli- B.C.T. 2 117 0052388 JNJ 000343161 R. RUSSELL R. D. MERZ W. T. SHERman and J. N. SIVERTSON cations was this purpose he chosen for This modular unit contains a crystal sensor nonpulsing vac- cyclone 10 uum pump to provide airflow to the and a chart recorder _ mm The cumulative mass of respirable particles which were fractionated by the cyclone was collected on the cumulations as low as 01 gcould be read directly immediately from the chartrecording made by sampling the air powdering during the nasal openings nylon cyclone : study collection - Before initiation of the Measurements were adjacent to using the 10 mm the eff- dency of the TSI Mass Monitor for take particles of a respirable size was tested using the following pro- dureA low density talc airborne concentration less than 5 mg respirable particle content was gener- rated in a closed chamber and sampled with the 10mm nylon cyclone prefilter at the preferred flow " Trate 1.7 litres The air stream containing the respirable = talc particles was then divided with a pre- cision splitter and 1 litre passing to the mass recorder and 0-7 litres passing to a 13 mm mem- brane filter of 0-8 mpore size The mass recording readout on the instrument was then compared with the : mass collected on the membrane filter and -: weighed on an electromicrobalance : It was determined that good agreement within % could be obtained between recorder and gravimetric _ readings if the mass loading on the crystal sen- g sor was kept below 15 talc As the crystal mass loading increased beyond 15 ...gthe talc particle deposition efficiency fell off and disparity between recorder reading and gravimetric increased readings In this study mass accumulations were below 15 g for all individual tests powdering procedure A group of eight - mothers with infants under 16 months of age who regularly used a leading brand of talcum powder at nappy changing time p^/rticipated in this phase of the study Mothers were supplied with a 36 high ~ changing table and mat an appropriately sized dis- posable napkin and powderin its commercial 14 oz were twist canister All six canisters used , the same lot from -. Each mother was instructed to remove the napkin on her own infant powder the oapkin area as she - normally would and place a new napkin on the baby ~ When the task was completed she was instructed to pick up her child signalling an end to the nappy- changing procedure This procedure was repeated Johnson's Baby Powder three times in succession for each mother pair the results being averaged Determinations of total exposure time amount of powder used and average tal concentration in the air at the level of the infant's nares were made Before running each test the area was vacuumed to remove airborne left from particles the previous test airborne To sample the powder the cyclone inlet was held next to the baby's head approximately 4 in above the surface of the changing mat Fig ) Total exposure time was defined from the first shake of powder to the end of nappy changing The investi- carried gations were periods out over two four time Adult powdering procedure Twenty adult males and twenty adult females who routinely used the same leading talcum powder daily were testedin this phase of the investigation All normally applied the powder directly to their bodies or to their hands before application to the body Subjects were asked to shower towel dry enter a small powder 3.75 ^ 5 ^ 7 ft anteroom and apply from a new oz twist canister to their bodiesin their normal manner This anteroom procedure assured a constant environment for the equipment which is sensitive to high levels of humidity and to the tem- perature and humidity fluctuations that could occur with the opening and closing of the bathroom door On entering the anteroom each subject donned a headband with the attached cyclone which was positioned at the level of the individual's nose Fig 2 Using a stopwatch each subject was timed for the duration of the powdering procedure from the first shake of the canister to the moment body powdering was completed and the subject left the powdering anteroom Again the total exposure time quantity of powder used and average talc concentration in the air at the level of the adults nares were determined four The investigations were carried out over two time periods RESULTS The results of the trials are summarized in Table 1 Frequency distributions of exposure concentrations for both infant and adult data are given in Tables 2 and 3. For infant exposures the weighted average SD was 0-095 -0-039 and weighted for adult exposure the 1-727 mg min average was The exposure factor is defined as the number of times by which the TWA for talc workers Table 1. Exposure of infants and adults to respirable talc particles No. of subjects Weight of tale used g * Exposure time min Concentration mg Infantst Adults 48 44 . 088 -063 8.84 -8-32 052 -017 1.23 -0.55 0-19 -084 2-03 -1.49 eae . respirable Average concentration in mg was calculated by dividing the weight of particles collected by the volume of air sampled for each subject and averaging . the results The flow rate to the mass monitor was 1 litre therefore the expo- sure time in minutes was equal to the air volume in litres consecutive infant during Because of the very low airborne respirable concentrations ing it was necessary to use the mean of three the infant powder- tests on each 0052389 JNJ 000343162 Fig 1. Simulation of particle collecting cyclone positioned at the level of baby's nares during nappy change powdering Fig 2. Particle collecting cyclone attached to a headband and positioned at the level of the subject's nares during adult whole powdering 119 es keeaees Sk KOC 34! a Relreyrgaie e Ny Aa 0052390 JNJ 000343163 . Determination of respirable particles in talc : 121 Table 2. Frequency distribution of infant exposure mg.min mg.min to respirable talc particles 120 mg.hr/m/wk mg.hr/m/wk was then divided by the average infant or adult weekly weighted values and the Exposure levels mg.min mg.min No. of infants within exposure level Percentage of infants within exposure level exposure factors were calculated to be 2182 for infants and 600 for adults Exposure factors calculated from the 90 tolerance limit for the 95th percentile for each group were 1212 and 98 respectively . 010-019 4 8-33 The above exposure data were also compared with 0-20-0-29 .15 31-25 the data of Wehner Wehner et al 1977a from a ham- - 030-039 . 040-0-49 0-50-0-59 0-60-0-69 0-70-0-79 - 19 6 3 0 1 39-58 12-50 625 0:00 2-08 ster inhalation study In this case the effect level for the hamsters mg.hr/m/wk exceeded the respectively and exposure levels of the infants * 500 times adults 1818 and Data for the mean of three exposures The weighted average SD for three exposures . was 0-285 -117 mg.min the average for one exposure was 0-095 -0-039 min Because these results approximated a normal distribution parametric statistical procedures were applied to the raw data Table 3. Frequency distribution of adult exposure mg min to respirable tale particles Log exposure levels ' min No. of adults within exposure level " -1 to 1 36 1 -1.35 to -0-90 to -045 to -091 -0.46 -001 3 4 3 . 0-00-0-44 9 - 089 9. 090-1-34 6 1-35-1-79 S 1-80-2-24 2 2-25-2.69 2 Percentage of adults within exposure level 2-27 683 9-09 682 2045 2045 13-64 11.36 4.55 4.55 The adult_exposure adult_exposure data closely approximated a lognormal distribution Therefore a leg transformation was made to normalize the data and parametric statistical procedures were applied to the transformed data The log of the weighted average exposure SD was 0-5464 -09339 and antilogs allowed estimation of the original population the weighted average being . 1.727 min exceeds the weighted average concentrations determined for infants and adults in this study Exposure factors were calculated by dividing the weekly TLV concentration for tale workers by the calculated weekly concentrations for either infants or adults The weighted exposures for infants and adults were converted to weekly exposure concentrations by multiplying by the number of applications per day and by seven week and dividing by 60 min J. N. Sivertson unpublished data 1976 has shown that mothers who are regular users of baby powder powder their infants ( to 24 months old an average of five times One powder application each day was assumed for adults The average values obtained were 055 and 0-20 mg.hr/mfor infants and adults respectively The corresponding 90 tolerance limits for the 95th percentiles were found to be 0-099 and 1-23 Diem 1962 The tale TLV of mg was converted to a weekly exposure for the tale workers assuming a 40 working week This figure of - DISCUSSION The background level of respirable particles in the area of the tests was monitored and found to be less than 003 mg It was determined that background particles would increase the concentration by a maxi- mum of % under the most severe conditions encoun- . tered e.g. 1-5 min of exposure and 0-1 gtotal respirable mass collected Therefore background was not considered in calculating the exposure concentrations _. It was interesting to observe the different methods of powder application quarters of the mothers applied the powder directly to the baby's body and the remainder placed the powder in their hands and then on the baby One mother applied the powder to the napkin Analysis of data resulting from the various application methods showed no significant differences in any of the monitored parameters The average adult exposure concentration 2-03 mg was over ten times greater than that found for infants 0-19 mg Adults were also exposed for a longer time period 23 min compared with 0-52 min for the infants On average men tended to powder in a shorter time than women but to use more powder and create greater airborne respirable ; particle concentrations . It is noteworthy that Wehner et al 1977a were unable to produce any related toxicity in hamsters with extensive exposures to 8 mg of respirable tale The same group later demonstrated that although the talc deposited in the deep lung it was cleared with a biological half of 7-10 days Webner Wilkerson Cannon Buschbom & Tanner . 1977b Acknowledgements authors wish to thank Steven R. Phillips and Constance L.Seaman for their assistance REFERENCES American Conference of Governmental Industrial Hygienists 1977 Documentation of the Threshold Limit Values for Substances in Workroom Air ACGIH Cincin- nati Ohio Ayer H. E. Sutton G. W. & Davis I. H. 1968 selective gravimetric sampling in dusty industries Am ind Hyg Ass J. 29 336 . Caplan K. J. Doemeny L. J. & Sorenson S. D. 1977 Performance characteristics of the mm cyclone respir- able mass sampler part monodisperse studies Am ind Hyg Ass J. 38 83 Cochrane T. S. 1972 Routine dust measurements and standards Can Mining & Met Bull January p 46 i 0052391 0052391 JNJ 000343164 122 R. S. Russell D. MERZ W. T. SHERMAN and J. N. SIVERTSON . "2 . Diem K. Editor 1962 Documenta Geigy Scientific . Tables 6th Ed pp.45 & 168. Geigy Pharmaceuticals Ardsley N.Y. . _ Ettinger H. J. Partridge J. E. & Royer G. W. 1970 -Calibration of stage air samplers Am ind Hyg Ass ation of selective presamplers II Efficiency of the mm nylon cyclone Am ind Hyg Ass J. 32. 441 Wehner A. P. Zwicker G. M. Cannon W. C. Watson C. & Carlton W. W. 19778 Inhalation of tale baby _ powder by hamsters Fd Cosmet Toxicol 15 121 537 : Wehner A. P. Wilkerson C. L. Cannon W. C. Busch- Lippmann M.:(1970 M.:(1970 Respirables dust sampling Am Hyg Ass ind J. 138 | Seltzer D. F. Bernaski W. J. & L^nchJ. 1971 Evalu- bom R. L. & Tanner T. M. 1977b Pulmonary deposi tion translocation and clearance of inhaled neutronactivated tale in hamsters Fd Cosmet Toxicol 15 213 a 0052392 JNJ 000343165