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@ cc A. Netherwood February 24 1977 NOTES ON Normal Use Levels of Respirable Preliminary Studies IRI Project No. 404259 Talc This study depends upon assay of mg by atomic absorption spectroscopy AAS to determine the weight of respirable talc particles collected Sampling is with a Cassella cyclone at a flow rate of 1.9 min fraction fraction is trapped on a 0.8u pore size membrane filter for subsequent size analysis by microscope and mass determination by AAS In this study the sampling device was placed relatively far away from the subjects noses when compared to our & studies Infant dusting Adult dusting IRI doll Study 6 to 1 to 12 3 ft & Study Live baby " to " 2 The Casella cyclone is battery powered pumps a bulkier instrument with its own In the IRI study the sampling time was 5 min for a single powdering test although actual powdering application times were about 1 min Since the concentration of re- spirable particles was calculated by dividing the u grams collected by the sampling time 5min or 9.51 the actual concentration was necessarily much higher during the 1 min of exposure during powder application In the & during the 1-1 min adult study the actual powdering concentration was application which measured averaged only The IRI talcs study finds Our studies no difference in perfumed vs. unperfumed with 66 talc only show a marked reduction in respirable airborne particles when perfume is added The lowest mass detectable by AAS is 1 microgram Therefore the lowest concentration detectable is or 1 ugram min 9.5 5 min = 0.1 L 0.1 m of talc m 0.1 mg Protected Document to Protective order JNJ 000059580 Normal Use Levels of Respirable Preliminary Studies IRI Project No. 404259 Talc Results In the data below the IRI summary Chinese and Italian talc perfumed J data used JBP only includes all data with and unperfumed The A Baby Dusting Range mg 3 Average mg Subject No. of Tests IRI Study 0.1 to 0.90 0.22 Doll 32 J Study 0.07 to 0.39 0.21 Live Baby 48 B Adult Dusting Range Mm Average mg Subject No. of Tests 0.3 to 2.6 1.13 Adult 32 0.12 to 5.10 1.61 Adult JBP Users 20 The IRI study does not give the amount by the subjects but from the data it more was used on the dolls than on the of powder dispensed appears that a lot live babies I believe the higher results with adults in the & study reflect the fact that sample was collected only during powdering highest exposure The IRI sampling continued for 5 min although application time was only around one Quell Rs R. S. Russell by Protected Document to Protective order JNJ 000059581