>A 747-R-92-003
Sq>tember 1992
A Laboratory Method to Determine the
Retention of Liquids on the Surface of Hands
by
Christina Cinalli, Charles Carter,
Arthur Clark, and Douglas Dixon
Contract No. 68-02-4254
Project Officer
Elizabeth F. Bryan
Exposure Evaluation Division
Office of Pollution Prevention and Toxics
Washington, DC 20460
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF POLLUTION PREVENTION AND TOXICS
WASHINGTON, DC 20460
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DISCLAIMER
This document has been reviewed and approved for publication by the Office of
Pollution Prevention and Toxics, Office of Prevention Pesticides, and Toxic Substances, U.S.
Environmental Protection Agency. The use of trade names or commercial products does not
constitute Agency endorsement or recommendation for use.
11
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TABLE OF CONTENTS
Page No.
1. INTRODUCTION 1
1.1 Purpose and Scope 1
1.2 Organization of the Report 3
2. EXPERIMENTAL METHOD 5
2.1 Experimental Subjects 6
2.2 Liquids Applied 8
2.3 Liquid Application and Removal Techniques 8
3. DATA ANALYSIS AND INTERPRETATION 11
3.1 Wipe Tests 11
3.2 Immersion Test 17
4. SUMMARY 20
APPENDIX A. Documentation of Compliance with 45 CFR 46:
Protection of Human Subjects 24
APPENDIX B. Method for Determining the Surface of Hands 44
APPENDDC C. Liquid Density and Viscosity Measurements 48
APPENDDT D. Liquid Application/Removal Procedures 53
APPENDIX E. Data Tables: Amount of Liquid Retained on the
Surface of Hands, Wipe and Immersion Tests 57
APPENDK F. ANOVA Tables: Amount of Liquid Retained on the
Surface of Hands, Wipe and Immersion Tests 60
111
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LIST OF TABLES
Page No.
Table 2-1. Hand Measurements of Experimental Subjects 7
Table 2-2. Viscosity and Density of Experimental Liquids 9
Table 3-1. Means of Liquid Amounts Retained on the Surface of
Hands (mg/cm2), Initial Wipe Test 12
Table 3-2. Means of Liquid Amounts Retained on the Surface of
Hands (mg/cm2), Secondary Wipe Test 13
Table 3-3. Aggregated Means of Liquid Amounts Retained on the
Surface of Hands (mg/cm2), Wipe Tests 16
Table 3-4. Means of Liquid Amounts Retained on the Surface of
Hands (mg/cm2), Immersion Test 18
Table 4-1. Means of Liquid Amounts Retained on the Surface of
Hands(mg/cm2), All Tests 22
Table 4-2. Means of Liquid Film Thickness on the Surface of
Hands (10'3 cm), All Tests 23
Table B-l. Hand Perimeter and Area Measurements 46
Table B-2. Hand Thickness Measurements 47
Table E-l. Amount of Liquid Retained on the Surface of Hands
(mg/cm2), Wipe Tests 58
Table E-2. Amount of Liquid Retained on the Surface of Hands
(mg/cm2), Immersion Test 59
Table F-l. ANOVA Statistics for Amount of Liquid Retained on the
Surface of Hands after Application, Wipe Tests 61
Table F-2. ANOVA Statistics for Amount of Liquid Retained on the
Surface of Hands after Partial Removal, Wipe Tests 62
IV
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1. INTRODUCTION
1.1 Purpose and Scope
This report was prepared for the U.S. Environmental Protection Agency (EPA), Office
of Pollution Prevention and Toxics (OPPT), to supply specific information needed to perform
exposure assessments. The purpose of mis report is to present data collected in three laboratory
trials designed to quantify the amount of liquid deposited onto the surface of hands. This
information is needed to calculate dermal exposure using the film thickness methodology
developed in Volume 7 of the Methods for Assessing Consumer Exposure to Chemical
Substances series (Jennings et al. 1987).1 For information regarding other dermal exposure
methods and for specific information on the development of the film thickness method for
determining dermal exposure, the reader is referred to Volume 7.
The basic equation for estimating annual dermal exposure via a liquid film
is as follows:
PDR « WF x DSY x DIL x T x AV x FQ (1)
where
PDR « potential dose rate (mg/yr)
WF = weight fraction of chemical substance in product
DSY = density of formulation (mg/cnr)
DIL « dilution fraction
AV » skin surface area exposed (cm2/event)
FQ « frequency of events per year
and
Jennings PD, Hammerstrom KA, Adkins LC, Chambers T, Dixon DA. 1987. Methods for
Assssing Exposure to Chemical Substances. Volume 7. Methods for Assessing Consumer
Exposure to Chemical Substances. Washington, DC: U.S. Environmental Protection Agency,
Office of Toxic Substances. EPA 560/5-85-007.
1
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T = film thickness of liquid on skin surface (cm)
__ Amount of liquid retained on skin Cmg/cnA
density of liquid (g/cm3) x 1,000 (mg/g)
(2)
The first three variables in Equation (1) are used to estimate the concentration of the chemical
being assessed. The volume of liquid is determined by multiplying the film thickness (T) of the
liquid on the surfiace of the skin (cm) by the area of skin (AV) likely to be exposed per event
(cm2/event). Because of the paucity of data on film thicknesses on the surface of hands (T),
laboratory studies were conducted to generate the needed data. The complexity and expense of
designing an experiment that controls all variables and examines a random population was
beyond the scope of this set of laboratory experiments. Instead, the studies were designed to
generate rough, order-of-magnitude values for film thicknesses to be used as a first cut method
to estimate dermal exposure assessments. The data used to calculate the film thickness using
Equation (2) are presented in the following chapters.
Three sets of experiments were performed applying various liquids to the hands of
volunteer human subjects. The amount of liquid retained on the subjects' hands and the density
of the liquid were measured to determine the liquid film thickness. The amount of liquid
retained was measured as a function of the identity of the experimental subject, the type of liquid
applied, and the method of experimental application and a subsequent removal. Replicate liquid
retention measurements were taken for each subject-liquid-application/ removal combination.
Six liquids were selected for use in the original study: three non-aqueous and three
water-based liquids. The liquids were selected because they were nontoxic to the human subjects
and because they represented a range of viscosities and, therefore, a range of likely retention
values as well. Retention measurements for the water-based liquids of the first experiment were
non-uniform and difficult to reproduce. These difficulties may have been caused by an inability
to estimate the possibly high volatilization/evaporation losses of the liquids. A further difficulty
with the measurements was associated with somewhat different experimental procedures
employed in the first and later experiments. The differences between first and later (second and
third) experiments included use of a different type of one liquid, use of a different type of liquid
wipe cloth, and use of slightly different methods of liquid application and removal by different
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experimental personnel. Because of these differences and the difficulties they posed for the
analysis of data from the first experiment, the data on water-based liquids were dropped from
further consideration and are not presented in this report.
The current study focuses on retention on hands of nonaqueous liquids. For each
subject-liquid combination, three different methods of liquid application, or testing, were
employed: initial wipe, secondary wipe, and immersion. The initial wipe test consisted of the
subjects wiping their hands with a cloth saturated in the liquid. The amount of liquid retained
on the hands was measured immediately after the application and also after subsequent partial
and full removals by a dry cloth designed to remove liquid from the hands. The dry cloth was
weighed before and after each test to obtain the amount of liquid removed. Subjects' hands were
thoroughly washed before each initial wipe application.
Secondary wipe applications were the same as initial wipe applications except for the
important difference that secondary wipe tests were conducted directly after initial wipe tests
with no intervening washing of hands. The secondary wipe tests were thus designed to measure
decreased retentions caused by the skin's being saturated with liquid from the initial wipes.
Immersion applications, designed to simulate worst-case maximum exposure events, consisted
of dipping subjects' hands into a container of the liquid. The amount of liquid retained on the
hands was measured indirectly immediately after immersion by weighing the jar of liquid before
and after immersion. The amount of liquid was also measured after a partial removal by a dry
cloth by weighing the cloth before and after it contacted the subject's hands. As with the initial
wipe tests, the subjects' hands were thoroughly washed before each immersion test replicate.
1.2 Organization of the Report
Section 2 of this report describes the experimental procedures used during the study.
Details of all three studies are included. Section 3 reports on data analysis and interpretation
of the data. Section 4 summarizes the main experimental results and presents them, tabularly,
as mean values.
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Appendix A contains the documentation on compliance with 45 CFR 46 - The Protection
of Human Subjects. Appendix B describes the method used to calculate the surface area of the
subjects' hands. Appendix C describes the methods used to determine the density and viscosity
of the test liquids. The laboratory reports are also included. Appendix D details the liquid
application and removal procedures, which are written as detailed instructions for the
investigator. Appendix E presents the raw data for all three sets of experiments using the
oil-based liquids. As mentioned in Section 1.1, the data for the water-based liquids collected
in the first two lab studies have been dropped because the data were found to be unreliable;
therefore, those data are not presented in this volume. Appendix F presents the statistical
analysis tables for the raw data.
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2. EXPERIMENTAL METHOD
Measurements of the amount of liquid retained on the hands of four human subjects were
made. The measurements were taken for each of three different liquids that were separately
applied to the subjects' hands. For each subject and each liquid, the measurements were
repeated for each of three different liquid application techniques (initial wipe, secondary wipe,
and immersion) and two different removal techniques (partial removal, full removal). The first
two application techniques (initial wipe and secondary wipe) were used with both removal
techniques (partial and full), and the remaining application technique (immersion) was used with
only one removal technique (partial removal). Four liquid retention replicates (one from
Experiment Two and three from Experiment Three) were taken for each of the single
application/double removal test combinations Cue., initial wipe application/partial and full
removal and secondary wipe application/partial and full removal) giving
4 replicates per subject-liquid-application/removal combination
x 4 subjects
x 3 liquids
x 2 application/removal techniques
= 96 replicates
for each combination or 192 total liquid retention replicates for both application/removal
techniques. Six replicates (three each from Experiments Two and Three) were taken for the
single application/single removal combination (immersion test) giving
6 replicates per subject-liquid-application/removal combination
x 4 subjects
x 3 liquids
x 1 application/removal technique
= 72 replicates
for that test combination.
Thus, a three-factor experimental design was used to collect and analyze the liquid
retention data. The three factors, or explanatory variables, influencing the amount of liquid
retained on skin were (1) the identity of the human subjects (and the surface areas of their hands)
on which the liquids were applied, (2) the different types of liquid applied (with different
viscosities and densities), and (3) the different methods used to apply and remove the various
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liquids from the subjects' hands. The remainder of this section discusses the measurement
procedures associated with each of the three experimental factors.
2.1 jfoqperimental Subjects
Amounts of liquid (mg) were applied to and removed from the hands of the four human
subjects (A, B, C, D). Dividing the amounts of liquid retained by the surface areas (cm2) of
the subjects' hands gave the amount of liquid retained per unit surface area of skin (mg/cm2).
Since human subjects were involved in the experiments, their protection fell under regulation
of 45 CFR 46 of the Department of Health and Human Services (HHS). The project was
conducted according to the procedures of the regulation and was found to be in compliance by
an institutional review board. Detailed compliance documentation for the first experiment is
included in Appendix A. Since Experiments Two and Three used the same procedures and
materials as Experiment One, these later experiments were also in compliance.
The total surface areas of the subjects' hands were estimated from the
"cookie-cutter" formula:
where
SA
S
P
t
SA = 2-S + p't
Surface area of hand (cm2)
Surface area of palm of hand or surface of back of hand (cm2)
Perimeter of hand (cm)
Average thickness of hand (cm).
Individual hand tracings were used to estimate, by digitizer, S and p, and caliper measurements
were used to estimate t. A detailed description of the measurement procedure used to determine
SA is included in Appendix B of this report. The results of the procedure, the listings of p, t,
S, and SA, for all four experimental subjects are listed in Table 2-1.
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Table 2-1. Hand Measurements* of Experimental Subject!
Subject
A
B
C
D
t
Left
hand
2.8
2.1
2.5
2.5
(cm)
Right
hand
2.7
2.1
Z5
2.8
p
Left
hand
106
90
98
107
(cm)
Right
hand
106
88
99
107
S
Left
hand
170
115
148
168
(cm2)
Right
hand
164
103
150
163
Left
hand
637
419
541
603
SA(cm2
Right
hand
614
391
548
626
Both
hands
1,250
810
1,090
1,230
* Measurement! rounded to no more than three significant digits to reflect measurement error.
Source: Appendix B, Tables B-l and B-2.
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2.2 pquids Applied
Initially, six liquids were selected for use in the study, but, as already noted, three were
omitted because an acceptable experimental procedure to address volatilization/evaporation losses
could not be developed for them. The liquids omitted were water/oil emulsion (50:50,
water:water-soluble oil); water; and water/ethanol (50:50). The three liquids (all oils) that were
used in the two experiments were:
Mineral oil (Giant Food Inc.);
Cooking oil (Crisco); and
Bath oil (Gray Drugs, Inc. and Rite Aid, Inc.).
The oils were selected because of their suitability for human use (non-toxic) and their varying
viscosities. The difference in viscosities, and slight difference in densities, was intended to lend
some variability to the experimental results, thereby making the results more representative of
actual exposure conditions. In all cases, the liquids were applied and removed with 100 percent
cotton cloths.
The density and viscosity of each oil was measured by an outside laboratory. The results
of the measurements are presented in Table 2-2. The measurements verified that the density and
viscosity of each oil type were approximately the same for both experiments. A detailed
description of the density and viscosity measurements is included in Appendix C.
2.3 Liquid Application and Removal Techniques
Three combined application/removal techniques, or tests, were used to expose subjects
to the liquids selected for study. The methods used by the subjects to apply and remove each
liquid from the subjects' hands are summarized here and described in detail in Appendix D of
this report. In the initial wipe test, each subject's hands were first thoroughly washed and then
the liquids were applied to their hands from a cloth saturated in the liquid. The amount of liquid
first retained on the hands was then found by simply calculating the difference between the
before and after application weights of the cloth (and holding cup). Separate dry removal cloths
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Table 2-2. Viscosity* and Density*1 of Experimental Liquids
Liquid
Mineral oil
Cooking oil
Bath oil
Kinematic
viscosity
(cSt)e
160.2
593
33.3
Density
(g/cnr*)
0.870
0.920
0.861
* Measured at 23 *C for viscosity.
b Measured at 24.5*C for density.
c Centistokes, one one-hundreth stoke, the kinematic unit of viscosity; it is equal to the viscosity in poises divided by the
density of the fluid in grams per cubic centimeter, both measured at the same temperature. (Hawley I, Goodrich G.
1981. The Condensed Chemical Dictionary. 10th ed. New York, NY: VanNostrand Reinhold Company.)
Source: Measured at Gascoyne Laboratories, see Appendix C.
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were then used to wipe the hands both partially and fully (see Table 2-2 Appendix D for
explanation of partial and full wipe procedures). Subtracting the differenced weighings of the
removal cloth (and holding cup) from the amount of liquid first retained yielded the amount of
liquid remaining on the hands after the partial and full removal, respectively. The experimental
data are summarized in Appendix E, Table E-l.
A "secondary wipe" test was also performed on the subjects. The procedures of this test
were the same as those of the initial wipe test with the important exception that the secondary
wipe tests immediately followed the initial wipe tests with no intervening washing of hands. A
detailed description of the secondary wipe experimental procedure is included in Appendix D,
and the accompanying experimental data are listed in Appendix E, Table E-l.
The third application/removal test used in the project was an "immersion" test. In this
test, subjects dipped their hands (thoroughly washed) directly into a container holding the liquid
and then wiped their exposed hands, first partially then fully, with separate, initially dry,
removal cloths. Because an analytical balance of sufficient combined capacity and accuracy did
not exist to directly weigh the container of liquid before and after application, the amount of
liquid first retained was indirectly estimated by adding the differenced weighings of both partial
and full removal cloths (with holding cups) to the previously estimated amount remaining after
"full" removal from the initial wipe test. The amount remaining after partial removal was
estimated by subtracting the differenced weighing of the partial removal cloth from the amount
estimated to be first retained. A detailed description of the immersion experimental procedure
is included in Appendix D, and the accompanying experimental data are listed in Appendix E,
Table E-2.
The amount of liquid retained (per unit area) on skin for each application/removal test
combination divided by the previously measured densities of liquids gave the estimated film
thickness of liquid on skin surface, T, needed for estimating dermal exposures from
Equation (1).
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3. DATA ANALYSIS AND INTERPRETATION
The liquid retention data for the three tests of this project (initial wipe, secondary wipe,
immersion) were analyzed as data from a three-factor, fixed-effects analysis of variance
(ANOVA) experimental design. The objective of the analysis was to determine which factors
(human subject, liquid type, application/removal method) or combinations of factors had a
significant effect on the variability of the experimental results for liquid retention per unit skin
surface area (mg/cm2). The ANOVA tables for the three tests are listed in Appendix F, Tables
F-l through F-5. The tables present the mean squares, variance ratios, and significance
probabilities for the important factors of each test. In this section, the results of the analysis in
terms of the tables of (liquid retention) means for each test are discussed.
3.1 Wipe Tests
Tables 3-1 and 3-2 present the following information for the initial and secondary wipe
tests:
Replicate means for each experimental subject (A, B, C, D)-liquid type (mineral oil,
cooking oil, bath oil)- application/removal (application, partial removal, full
removal) factor combination;
Experimental subject (row) means for each application/removal level (application,
partial removal, full removal); and
Liquid type (column) means for each application/removal level.
The standard error for comparing the difference of any two row means, within or between the
tables, is v(2 x .053/12) = 0.094. If two row means differ by more than twice this amount,
they are considered distinct at an approximate significance probability of 95 percent. Inspection
of Tables 3-1 and 3-2 shows that, at each application/removal level, at least one, and usually
more than one, pair of significantly different row means exists. Thus, as confirmed by the
ANOVA of Appendix F, Tables F-l through F-3, experimental subjects (rows) were a
significant source of experimental variability: different subjects had significantly different
capacities to retain liquid on the surface of their hands.
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Table 3-1. Means of Liquid Amount* Retained on the Surface of Hands (mg/cm2), Initial Wipe Test
Application/removal* replicate means
Mineral oil
Cooking oil
Bath oil
Application/ Overall
removal* Row
Row meansb>f
Experimental subjects,
A
B
C
D
Application/removal*
column means'*'
Overall column means'
*,f
1.61, 0.76, 0.59 3.05, 1.15, 0.63 1.93, 0.72, 0.22 2.20, 0.88, 0.48 1.19
1.28, 0.57, 0.24 1.79, 0.69, 0.20 1.59, 0.66, 0.29 1.55, 0.64, 0.24 0.81
1.20,0.39,0.11 2.17,0.68,0.36 1.23,0.37,0.13 1.53,0.48,0.20 0.74
1.33, 0.45, 0.02 1.27, 0.46, 0.08 1.22, 0.29, 0.04 1.27, 0.40, 0.05 0.57
1.36,0.54,0.24 2.07,0.75,0.32 1.49,0.51,0.17 1.64,0.60,0.24
0.71
1.05
0.72
0.83
* Table triplet entries = amount retained after application, amount retained after "partial* removal, amount retained after
"full" removal.
b Standard error of each application/removal row mean = V(MSE/12) «= 0.067, where MSB « 1I3(0.106 + 0.025 +
0.029) = 0.053 a the average error mean square from the ANOVA Tables F-l, F-2, and F-3 of Appendix F.
Standard error of each overall row mean «= v(MSE/36) = 0.038.
d Standard error of each application/removal column mean = V(MSE/16) = 0.058.
e Standard error of each overall column mean = V(MSE/48) «= 0.033.
Standard error of each mean difference = v (2 x Standard error of each mean).
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Table 3-2. Means of Liquid Amounts Retained on the Surface of Hands (rag/cm2), Secondary Wipe Test
Application/removal*
Mineral oil
Experimental subjects
A
B
C
D
Application/removal*
column means*'''
Overall column means6
* Table triplet entries «
134,
1.20,
1.11,
1.23,
1.22,
0.46,
0.52,
0.27,
0.40,
0.41,
0.03
0.15
0.01
0.01
0.05
replicate means
Cooking oil
2.45,
1.48,
1.77,
1.16,
1.72,
f 0.56
* amount retained aft
0.65,
0.55,
0.41,
OJ1.
0.48,
0.75
0.07
0.08
0.18
-0.09
0.06
er implication, irnmmt retained
Bath oil
1.56,
03,
1.12,
1.14,
134.
after "
0.44,
0.56,
0.30,
034,
0.41,
0.61
0.01
0.23
0.04
0.00
0.07
Application/ Overall
removal8 Row
Row meansb>f meansc>f
1.78,0.52, 0.04
1.40,0.54, 0.15
1.33,0.33, 0.08
1.18, 0.35, -0.03
1.43.0.43, 0.06
0.78
0.70
0.58
0.50
0.64
partial" removal, amount retained after
"full" removal.
b Standard error of each application/removal row mean - V(MSE/12) - 0.067, where MSE - V3(0.106 + 0.025 +
0.029) = 0.053 is the avenge error mean square from the ANOVA Tables P-l, F-2, and F-3 of Appendix F.
Standard error of each overall row mean
Standard error of each application/removal column mean < V(MSE/16) » 0.058.
e Standard error of each overall column mean « V(MSE/48) » 0.033.
f Standard error of each mean difference « V(2 x Standard error of each mean).
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Concerning the different liquids used in the tests, the standard error for the difference
of any two column means is V@ x .053/16) = 0.082. Twice this amount is less than the
difference of at least one and usually more than one pair of column means, at least for the
application and partial removal levels of both initial and secondary wipe tests. Thus, as again
confirmed by the ANOVA of Appendix F, liquid type was also a significant source of
variability: liquids of different viscosities were retained in different amounts on the surface of
hands. However, no correlation was observed between the viscosity and the amount retained.
It is also evident from both the column and row means in Tables 3-1 and 3-2 that the
application/removal method was a significant source of variability. In other words, as confirmed
by the ANOVA of Appendix F, significantly different amounts of liquid were retained after first
application, partial removal, and full removal. For both tests, partial removal retentions were
significantly less than first application retentions, and full removal retentions were significantly
less than partial removal retentions. Thus, all three experimental factors subject, liquid type,
and application/removal method-had a significant impact on the amount of liquid retained on
the surface of skin.
In addition to the three single factor effects, a number of multiple factor "interaction"
effects were also significant in contributing to experimental variability. The most important of
these interactions, as shown by the ANOVA Tables, F-l, F-2, and F-3, of Appendix F, were
the human subject interactions with both liquid type and application/removal method. The
subject-liquid type interaction refers to the relative differential retention of different liquids by
different subjects. For example, whereas one subject might retain 3 mg/cm2 more of liquid "L"
than of liquid "M," another subject might retain 5 mg/cm2 more of L than of M.
The subject-application/removal method interaction refers to the relatively different liquid
retentions of different subjects for different application/removal processes. For example,
whereas one subject, on average, might partially remove 4 mg/cm2 of the liquid initially retained
on his hands, another subject might, for the same liquid, partially remove only 2 mg/cm2 on
14
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average. Given the natural variability of most experiments involving human subjects, the
presence of these interactions was not surprising.
The subject-application/removal differential retention rates might have been further
compounded by different liquid types, leading to significant liquid type-application/removal
method and subject-liquid type-applicatibn/removal method interactions. Thus, for example, all
subjects might have, on average, partially removed 5 mg/cm2 of liquid L but only 3 mg/cm2
of liquid M, and different subjects might have partially (and fully) removed liquids L and M in
different amounts. However, the ANOVA Tables F-l, F-2, and F-3 of Appendix F show that,
for this experiment, the latter interactions were not significant.
In fact, the absence of a liquid type-application/removal method interaction guaranteed
the desirable result that the retention rates of the separate initial and secondary wipe tests were
simply additive. To see this, consider the values of the aggregated means shown in Table 3-3.
The differences between successive row (test) means in the table are shown within parentheses.
The difference between each pair of these successive differences (by column) is much less than
twice the standard error, 0.067, for comparison. Also, the differences between successive
column means (shown in braces) are not significant, with an average value equal to the
difference of the overall means, 0.19. Thus, when one aggregated over all subjects and liquid
types (or, because of the absence of a liquid type-application/ removal method interaction, over
subjects only), the resulting liquid retention amounts for the secondary wipe test were equal to
the corresponding amounts for the initial wipe test minus an average amount corresponding to
that retained after full removal, which in this experiment was approximately 0.2 mg/cm2.
The amount of liquid retained, therefore, for the initial wipe tests was in all cases greater
than that for the secondary wipe tests, the difference being approximately equal to the amount
retained after full removal (saturation residual). This suggested that the starting condition of an
individual's hands with lespect to the liquid in question was an important factor in exposure.
15
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Table 3-3. Aggregated Means* of Liquid Amounts Retained on the Surface of Hands (mg/cm2), Wipe Tests
AtJtjlieation/retnoval level
-
Initialb'c
Secondary1''6
Application
1.64 (1.04)
[0.21]
1.43 (1.00)
Partial
removal
0.60 (0.36)
[0.17]
0.43 (0.37)
Full
removal
0.24
[0.18]
0.06
Overall
meant
0.83
[0.19]
0.64
* Aggregated over subjects and liquids.
b Standard error of each row mean *= 0.033-K
c Standard error of each row mean second difference = 2 x 0.033+ 0.067.
Source: Tables 3-1 and 3-2.
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3.2 Immersion Test
The immersion test table of means is shown in Table 3-4. It is obvious from the table
that the three factors of experimental subject, liquid type, and application/removal method were
all significant sources of variability for the amount of liquid retained on skin. This is confirmed
by the factor significance probabilities of the ANOVA Tables F-4 and F-5 of Appendix F. The
tables also show the presence of a significant experimental subject-liquid type interaction.
Not surprisingly, substantially more liquid was retained in the immersion test (direct
liquid application) than in either the initial or secondary wipe tests (indirect liquid application).
Also not surprising was the fact that the liquid with the greatest viscosity (mineral oil) was
retained in greater amounts than were the liquids with less viscosity. Those less viscous liquids
(cooking oil and bath oil) were retained in statistically not unequal amounts, despite the fact that
one (cooking oil) had a viscosity about twice that of the other (bath oil). This was in contrast
to the results of the initial and secondary wipe tests where the higher viscosity cooking oil was
retained in significantly greater amounts than the lower viscosity bath oil. Any number of
hypotheses were available to explain the different results between the two sets of tests.
In the immersion tests, the lower viscosity bath oil may have penetrated skin folds more
deeply but also dripped off the wetted hand surface more easily than did the higher viscosity
cooking oil. Because of the counter-balancing tendencies of deeper penetration and greater
runoff, the result might have been retention of an approximately equal amount of the two oils
per unit of apparent (not counting fold areas) skin surface area. However, if the larger effective
surface area, because of low viscosity oil penetration, could have been estimated and used in the
calculations, then the lower viscosity bath oil might have indeed been found to have a lower
retention per unit of skin surface area than the higher viscosity cooking oil.
This situation, for cooking and bath oil, would not apply to the initial and secondary wipe
experiments, because in these experiments, the very act of application by wiping might rub both
oils into the skin folds equally. Thus, in the wiping experiments, the effective skin surface areas
17
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Table 3-4. Mean* of Liquid Amounts Retained on the Surface of Hands (mg/cm2), Immersion Test
Application/removal* replicate means
Experimental subjects
A
B
C
D
Mineral oil
11.90, 2.58
9.39, 1.53
9.53, 1.48
10.51, 1.41
Cooking oil
6.70, 1.93
5.96, 1.27
4.87, 1.15
6.53, 0.97
Bath oil
6.63, 1.49
5.15, 1.70
538, 1.23
6.61, 0.93
Application/
removal*
Row means'" -^
8.41, 2.00
6.83, 1.50
6.59, 1.29
7.88, 1.10
Overall
Row
means6*^
5.20
4.17
3.94
4.49
Application/removal* 10.33, 1.75 6.02, 1.33 5.94, 1.34 7.43, 1.47
column meansd>f
Overall column
means'^ 6.04 3.68 3.64 4.45
1 Table doublet entries = amount retained after application, amount retained after "partial" removal.
b Standard error of each application/removal row mean »= v'(MSE/18) = 0.112, where MSB "= J/2(0.27 + 0.18) *
0.225 is the average error mean square from the ANOVA Tables F-4 and F-5 of Appendix F.
c Standard error of each overall row mean «= V(MSE/36) = 0.079.
d Standard error of each application/removal column mean = V(MSE/24) = 0.097.
e Standard error of each overall column mean = V(MSE/48) «= 0.068.
f Standard error of each mean difference * V(2 x Standard error of each mean).
18
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would be more or less the same for both oils. As a result, the different retentions of the two
oils would not be masked.
In any event, if oil viscosity became sufficiently large (as with the mineral oil), then the
thicker layering of the oil on skin would far outweigh the decreased penetration effect. Thus,
overall, the very high viscosity mineral oil resulted in a larger immersion retention than either
the moderate or lower viscosity cooking and bath oils.
This was not true, however, in the wipe experiments where more cooking oil was picked
up. While this might seem odd, there may be a plausible explanation. It seems likely that in
the immersion experiments, higher viscosity liquids would adhere more to the hands. This
seems logical, and it is consistent with everyday experience. In the immersion experiment, when
the hand was removed from the container of more viscous liquid, the liquid (which had a greater
resistance to flow) would flow slowly back into the container. In the wipe experiment, the more
viscous liquid would resist flowing out of the pores of the cloth and thus less liquid would be
transferred to the hands. This again is consistent with everyday experience. If a cloth saturated
with an extremely viscous substance were picked up, one would expect relatively little liquid to
be transferred to the hands. Thus, the wipe experiments would be expected to yield relatively
smaller retentions of the high viscosity mineral oil than would the immersion experiments.
19
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4. SUMMARY
This report has presented and analyzed a set of experimental data pertaining to the
amount of liquid retained on the surface of hands. The findings of this study are summarized as
follows:
Significant factors affecting liquid retention variability were identified: the
individual subject upon whose hands liquid was retained, the type of liquid retained,
and the application/removal method associated with the liquid retained.
Significant combinations, or interactions, of factors affecting retention variability
were also identified. The most important such combinations involved the human
subjects exposed to the liquids.
The probable cause of the significance of factor interactions was the subjects
themselves. Although controls were applied to render the experimental results as
uniform as possible, the variability of the human subjects regarding skin
characteristics (e.g., thickness of the stratum comeum, hydration of the stratum
corneum, hairiness), self application and removal characteristics, and other
characteristics inevitably led to a corresponding significant variability in liquid
retention amounts. Put simply, subjects tended to retain different liquids (of
different densities, viscosities, etc.) in different amounts. Also, different subjects
tended to retain the same liquid in different amounts, primarily because of individual
differences associated with physical characteristics and behavioral differences
associated with different exposure (application/removal) practices.
Of the various experimental results reported herein, most were affected somewhat
by technique. For example, initial exposure from a cloth would depend on the
subjects' handling of the cloth. Any measurement requiring a partial "removal"
would be highly technique-sensitive and very subject-dependent.
The measurements that were believed to be least technique-sensitive were (1) the
amount adhering to the hands after immersion and (2) the amount that could not be
removed with a clean dry cloth (i.e., the amount remaining in the wipe experiments
after the full removal).
For the technique-sensitive measurements, the observation that the identity of the
subject had an effect on the results was not surprising, and it does not indicate real
differences in different people's potential for exposure. However, these differences
were also observed for measurements that were not technique-sensitive, and this
indicates real differences in the exposure potential for different people. Presumably,
these differences related to some physical characteristics of the people.
20
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The experimental results of the project are summarized in Tables 4-1 and 4-2. Table 4-
presents the mean amounts of liquid retained on skin for each liquid and eacl
application/removal method used in the experiment. Table 4-2 lists the mean film thickness o
liquid on skin for the same sets of variables, calculated using Equation (2). Because th<
densities of the liquids used in the experiment were roughly equivalent, the pattern of value;
obtained for film thickness is similar to that observed for liquid retention. The secondary wip<
film thicknesses were consistently less than initial wipe film thicknesses, presumably because
of skin saturation with liquid from the initial wipe. Also, partial and full removal filn
thicknesses were uniformly less than application film thicknesses. Finally, immersion filn
thicknesses were much greater than wipe film thicknesses, with high viscosity mineral oi
immersion film thicknesses being the greatest of all those calculated.
It was not possible within the scope of this project to collect liquid retention data foi
more than a few experimental subjects, liquid types, and application/removal methods. Thus,
sufficient data did not exist to perform an analysis of covariance study to quantify the
relationship between liquid retention amount, viscosity of liquid retained, and other experimental
variables. The limited results of this study are insufficient to quantify representative film
thicknesses corresponding to liquid viscosities; however, the results can be used as rough,
order-of-magnitude values in screening level exposure calculations. In order to obtain
representative values for film thickness, further method development would be needed, requiring
s
additional experiments using a greater number of individuals and wider range of liquid types
than were possible in the experiments discussed herein.
21
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Table 4-1. Means of Liquid Amounts Retained on the Surface of Hands (rag/cm2), All Tests
Initial Secondary Immersion
wipe test*'6'* wipe test*'"'* testb>d>e
Mineral oil 1.36,0.54,0.24 132,0.41,0.05 10.33, 1.75
Cooking oil 2.07, 0.75, 0.32 1.72, 0.48, 0.06 6.02. 1.33
Bath oil 1.49. 0.51, 0.17 1.34. 0.41. 0.07 5.94, 1.34
* Table triplet entries « amount retained after application, amount retained after partial removal, amount retained after full
removal.
b Table doublet entries » amount retained after application, amount retained after partial removal.
c Standard error of each mean 0.058.
d Standard error of each mean > 0.097.
e Standard error of each mean sum or difference * V2 x Standard error of each mean.
Source: Tables 3-1, 3-2, and 3-4.
22
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Table 4-2. Means of Liquid Film Thickness on the Surface of Hands (10~3 cm). All Tests
Initial
wipe test*
Secondary
wipe test*
Immersion
testb
Mineral oil
Cooking oil
Bath oil
1.56, 0.62, 0.27
2.25, 0.82, 034
1.74, 0.59, 0.20
1.40, 0.47, 0.06
1.87, 0.52, 0.07
1.56, 0.48, 0.08
11.87, 2.00
6.55, 1.46
6.90, 1.55
* Table triplet entries = film thickness after application, film thickness after partial removal, film thickness after full
removal.
b Table doublet entries = film thickness after application, film thickness after partial removal.
Source: Tables 2-2 and 4-1.
23
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APPENDIX A
Documentation of Compliance with 45 CFR 46
Protection of Human Subjects
24
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Vcrssu;
INC.
April 26, 1983
Dr. R. C. Backus
Office for Protection
from Research Risks
National Institutes of Health
Bethesda. HD 20205
Dear Dr. Backus:
I am enclosing the following material pursuant to your letter of
April 5, 1983 and our subsequent phone discussions.
1) Research Work Plan
2) Human Subject Consent Form and Research Summary
3) Compliance Statement
4) Minutes of the IRB meeting
I trust that this Information will be sufficient for your evaluation
of our proposed use of human subjects In research. Please do not
hesitate to call me at (703) 642-6759 should any questions arise. I
appreciate your attention to this matter and look forward to your
response.
Sincerely,
VERSAR INC.
**> <- u
Thomas C. Voice
Staff Research Engineer
Applied Chemistry Division
TCV/mb
25
6850 VERSAR CENTER P.O. BOX 1549 SPRINGFIELD, VIRGINIA 22151 TELEPHONE: (703) 750-3000 TELEX: 901125
-------
VERSAR INC.
Human Subject Consent Form
Project Title:
Project Number:
Name of Project Director:
Name of Principal Investigator:
Name of Subject:
Address of Subject:
Retention of Liquids on Hands
715.21
Gayaneh Contos
Thomas C. Voice
Telephone:
I consent to my (the subject's) participation In this resear
project and declare that I have been given:
1. an explanation of why the research 1s being done, how \t w1
be done, what Is being tried for the first time and how long
1s expected to take;
2. a warning about any risks or discomfort to be expected;
3. a description of any benefits to be expected;
4. the name of a person who will answer questions about th
research, the rights of a person In a research project or 1
case he or she 1s injured;
5. notice that 1t 1s not necessary to take part 1n the researc
and that one can drop out at any time without being penalize*
1n any way;
6. a promise that, to the extent permitted by law, any 1nformat1oi
about me (the subject) will be kept confidential and used onl;
for medical or research purposes and that my (the subject's!
name will not be used.
26
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I understand that, 1f I (the subject) am (Is) Injured because of the
way this research Is done, I (the subject) will not be compensated but I
(the subject) can receive emergency care at one of the local hospitals.
Signature of Participant
or Legal Representative: _____________________________ Date:
Signature of Auditor Witness: Date:
Relationship:
This 1s to affirm that the basic elements of Informed consent as
described above, and additional elements, 1f any, have been presented to
the subject or his/her legally authorized representative In accordance
with the attached summary. It Is also affirmed that this research
project and all relevant documentation, Including this form and attached
summary have been presented to and approved by an Institutional Review
Board conforming to the requirements of Health and Human Services
regulations 45 CFR 46, "Protection of Human Subjects."
Signature of Official
Obtaining Consent: __________________________ Date: _______________
Signature of
Auditor Witness: Date:
27
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Research Summary
The proposed research project "Retention of Liquids by Hands" Is
designed to quantify the amount of various classes of liquids that wm
be retained by human hands under controlled exposure conditions. It Is
the ultimate goal of this work to aid 1n the assessment of risk to
Individuals contacting liquids which may be contaminated by toxic
substances. This research, however, Involves only harmless, commonly
available liquids.
In the course of this research you will be asked to Immerse your
hands 1n two of the liquids listed below, which will be at room
temperature.
1. heavy mineral oil
2. cooking oil
3. water-soluble oil (Alpha-Kerl. a dry skin product)
4. oil/water emulsion
5. water
6. water/1sopropyl alcohol.
The liquid retained by your hands will be removed by wiping with a gauze
pad, either dry or wetted with 1sopropyl alcohol or other non-toxic
solvent. The liquid recovered will then be measured. You will also be
asked to have the area of your hand measured. This will be accomplished
by Immersing your hand 1n a water/food coloring solution and then
blotting a piece of paper or by tracing the outline of your hand.
Additional measurements with a ruler will be made. The entire procedure
should take about 30 minutes.
You are asked not to participate 1n this study If you have any
visible cuts or sores on your hands.
No additional risks, above those normally encountered 1n dally
activities, or any discomfort are expected as a result of this study.
Participation In this study 1s entirely voluntary and you can drop
out of the study at any time without penalty of any sort.
It 1s anticipated that this research will aid 1n the assessment of
risk to those Individuals who may be Inadvertently or unknowingly exposed
to toxic substances.
Any questions regarding this work should be directed to Or. Thomas
C. Voice at (703) 750-3000.
28
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sai*.
RETENTION OF LIQUIDS ON THE SURFACE OF HANDS
WORK PUN
April 25, 1983
This document proposes an experimental work plan to evaluate the
amount of liquid that can be retained on the surface of human hands under
different exposure scenarios. Since this value 1s obviously dependent
upon the amount of liquid contacting the hands, an upper bound will be
determined by Immersing the hands 1n the liquid of Interest, all of which
will be at room temperature. Additional test procedures will assess the
amount retained under simulated exposure conditions. Several different
liquids will be evaluated and an attempt will be made to correlate to the
liquid viscosity.
The following liquids have been selected for Investigation on the
basis of apparent bulk properties:
1. heavy mineral oil
2. light cooking oil
3. water soluble oil
4. oil/water emulsion (50:50)
5. water
6. water/1so-propyl alcohol (50:50)
Viscosity and density measurements will be made on each liquid.
Individuals with visible cuts or sores on their hands will be
eliminated from consideration as research subjects.
MAXIMUM EXPOSURE SCENARIO
To evaluate the retention capacity of hands the following
experimental procedure will be conducted 1n triplicate for each liquid:
1. A volunteer's hand will be Immersed 1n a container of liquid up
to a mark that has been placed at the wrist.
2. The hand will be removed and allowed to drip for a pre-
determined length of time to remove the excess liquid.
Alternatively, a gentle shake of the hand may be required to
remove the excess liquid expediently.
29
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The liquid will be absorbed from the hand by wiping completely
with surgical gauze pads that have been pre-welgned. The pads
may have to be wetted with a solvent (e.g., 1so-propyl alcohol
or other similar non-toxic solvent) to remove the oils. The
pads will be re-weighed to determine the mass of liquid
collected. If a solvent 1s used, the pad will be extracted,
the solvent evaporated, and the residue will be weighed.
An attempt will be made to quantify the amount of liquid
p1cked-up by each volunteer's hand by weighing the liquid
container before and after Immersion.
An attempt will be made to directly measure the film thickness
at various points on a volunteer's hand using non-1nvas1ve
techniques.
The surface area of each volunteer's hand will be approximated
by tracing the outline of the hand or by measuring a blot
obtained using a water soluble dye and directly measuring the
thickness of the hand. The total exposed area 1s thus:
(area of blot) x 2
+ ("perimeter" of blot) x (thickness)
total surface area of hand
The measurements of liquid mass retained by each hand will be
normalized with respect to surface area. If desired, a uniform film
thickness can be calculated using the liquid density. A least-squares
analysis will be used to determine the extent of any correlation between
normalized liquid retention and viscosity.
OTHER EXPOSURE SCENARIOS
Using Identical procedures as those outlined above, the following
additional scenarios will be evaluated:
1. Immersion followed by casual wiping with a clean rag.
2. Immersion followed by thorough wiping with a clean rag.
3. wiping up of a liquid spill with a clean rag.
30
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VERSAR INC.
Assurance of Compliance with HHS Regulations for
Protection of Hunan Research Subjects
PART 1
Versar Inc. hereinafter known as the "Institution," hereby gives
assurance that 1t will comply with the Department of Health and Human
Services (HHS) regulations for the Protection of Human Research Subjects
(45 CFR 46, as amended on January 26, 1981) as specified below.
I. Statement of Principles and Policies
A. Ethical Principles
1. This Institution 1s guided by the ethical principles
regarding all research Involving humans as subjects as set
forth 1n the report of the National Commission for the
Protection of Human Subjects of B1omed1cal and Behavioral
Research entitled Ethical Principles and Guidelines for the
Protection of Human Subjects of Research (the "Belmont
Report,*). In addition, the requirements set forth 1n Title
45. Part 46 of the Code of Federal Regulations (45 CFR 46)
will be met for all applicable research.
B. Institutional Policy
1. Except for research 1n which the only Involvement of human
subjects 1s 1n one or more of the categories exempted or
waived under 45 CFR 46.101(b)(l-5) or 46.10(e) of the HHS
regulations, this policy 1s applicable to all research
Involving human subjects, and all other activities which
even 1n part Involve such research, 1f either:
a. the research 1s sponsored by this Institution, or.
b. the research Is conducted by or under the direction of
any employee or agent of this Institution 1n connection
with his or her Institutional responsibilities, or
c. the research Is conducted by or under the direction of
any employee or agent of this Institution using any
property or facility of this Institution, or.
d. the research Involves the use of this Institution's
nonpubllc Information to Identify or contact human
research subjects or prospective subjects.
2. This Institution acknowledges and accepts Us
responsibilities for protecting the rights and welfare of
human subjects of research covered by this policy.
31
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3. This Institution assures that before human subjects are
Involved 1n research covered by this policy, proper
consideration will be given to:
a. the risks to the subjects.
b. the anticipated benefits to the subjects and others,
c. the Importance of the knowledge that may reasonably be
expected to result, and
d. the Informed consent process to be employed.
4. This Institution acknowledges that 1t bears full
responsibility for the performance of all research Involving
human subjects, covered by this policy.
5. This Institution bears full responsibility for complying
with federal, state or local laws as they may relate to
research covered by this policy.
6. This Institution encourages and promotes constructive
communication among the research administrators, department
heads, research Investigators, clinical care staff, human
subjects, and Institutional officials as a means of
maintaining a high level of awareness regarding the
safeguarding of the rights and welfare of the subjects.
7. This Institution will exercise appropriate administrative
overview carried out at least annually to Insure that Its
practices and procedures designed for the protection of the
rights and welfare of human subjects are being effectively
' applied.
8. This Institution will consider additional safeguards 1n
research when that research Involves prisoners, fetuses,
pregnant women, children, Individuals Institutionalized as
mentally disabled, other potentially vulnerable groups and
human In vitro fertilization.
9. This Institution shall provide each Individual at the
Institution conducting or reviewing human subject research
(e.g., research Investigators, department heads, research
administrators, research reviewers) with a copy of this
statement of ethical principles and policy (Part 1, I.A &
B.).
32
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PART 2
In regard to the project entitled Retention of liquids on Hands. Proiect
number 715.21. submitted on behalf of Thomas C. Voice, this Institution
has compiled and will continue to comply with the requirements of 45 CFR
46 as specified below.
I. IRB Review
A. The convened IRB reviewed and approved the above project.
B. The IRB has determined, In accordance with the criteria found
at 45 CFR 46.111, that human research subjects' protections are
adequate.
C. The IRB has determined that legally effective Informed consent
(copy of document attached) will be obtained 1n a manner and
method which meets the requirements of 45 CFR 46.116 and 46.117.
0. The IRB shall review, and have the authority to approve,
require modification In, or disapprove changes proposed In this
research activity.
E. The next scheduled meeting of the IRB for review of this
activity will be Nay 19, 1983. The IRB may be called Into an
Interim review session by the Chairperson at the request of any
member, an Institutional official, or the project director to
consider any matter concerned with the rights and welfare of
any subject.
F. The IRB shall prepare and maintain adequate documentation of
Us activities 1n accordance with 45 CFR 46.115.
6. The IRB shall report promptly to Institutional officials and
the Office for Protection from Research Risks (OPRR):
1. any serious or continuing noncorapllance by Investigators
with the requirements of the IRB, and
2. any suspension or termination of IRB approval.
H. The IRB shall report promptly to Institutional officials any
Information received concerning:
1. Injuries to human subjects, and
2. unanticipated problems Involving risks to subjects or others.
3. any changes In this research activity which are reviewed and
approved by the IRB.
33
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II. Research Investigator Reporting Responsibilities
A. Research Investigators shall report promptly to the IRfi
proposed changes 1n this research activity and the changes
shall not be Initiated without IRB review and approval except
where necessary to eliminate apparent Immediate hazards to the
subjects. '
fi. Research Investigators shall report promptly to the IRB any
unanticipated problems Involving risks to subjects and others.
III. Institutional Responsibilities
A. this Institution has provided and will continue to provide both
meeting space for the IRB and sufficient staff to support the
IRB's review and recordkeeplng duties.
B. This Institution shall report promptly to the OPRR:
1. Injuries to human subjects,
2. unanticipated problems Involving risks to subjects or
others, and
3. any changes 1n this research activity which are reviewed and
approved by the IRB and this Institution.
C. In addition to the review and approval of the IRB, this
Institution has reviewed and sponsors the project entitled
Retention of Liquids on Hands.
0. In accordance with the compositional requirements of section
46.107 of 45 CFR 46, this Institution has established an IRB as
listed 1n the following roster. This IRB 1s responsible for
the Initial and continuing review of this activity and will
observe the quorum requirements of 46.108.
34
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-------
PART 3
Institutional endorsement and HHS approval
regarding this assurance and the project
titled Retention of Liquids on Hands,
Project number 715.21.
I.
II
I certify that the above project was reviewed and approved by th
Versar Inc. IRB 1n accordance with the requirements of Part 46
Title 45 of the Code of Federal Regulations and this assurance o
compliance on April 21, 1983.
IRB Chairperson
Signature:
Name:
Address:
m&i
Charles
W
<,
/
/
ll
Date:
. Carter
*f
6850 Versar Center
P.O. Box 1549
Phone:
Springfield. Virginia 22151
(703) 750-3000
I certify that this Institution endorses the above project anc
abides by the principles, policies, and procedures of PARTS 1 and ;
of this assurance of compliance.
Authorized Institutional Official \pr1mary contact) /
Signature:
Name:
Title:
Address
Phone:
>-<*=>
Date:
Thomas C. Voice
Staff Research Engineer
6650VersarCenter
P.O. Box 1549
Springfield. Virginia 22151
(7031 750-3000
A******************************************************
-SPACE BELOW FOR HHS-
III. All parts of this assurance are 1n compliance with the requirements
of Part 46, Title 45 of the Code of Federal Regulations.
HHS Approving Official
Signature: ...
Name: _______
Title:
Address:
Date:
Phone:
36
-------
Versar Inc. Institutional Review Board
Minutes
Convened: Versar Inc. 4:00pro 21 April 1983
Discussed and made recommendations for changes on certain points within
the workplan form entitled 'Retention of Liquids on the Surface of
Hands." Scheduled next meeting for 4:00pm 19 May 1983.
Adjourned: 5:00pm 21 April 1983
Present:
IRB Members
Charles M. Carter, Chairman
Mark T. Carkhuff, Secretary
Angela N. Murray
Pamela A. H11l1s
Jordan E. Dickinson
Others
Thomas C. Voice
Mark T. CarltKuff
x
37
-------
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Serv,,
"" «-^ "*s
National Institutes 0
Bethesda. Maryland
May 5, 1983
Michael A. Callahan, Chief
Exposure Assessment Branch S 5156-01 (EPA)
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
Washington, D. C. 20460
Dear Mr. Callahan:
We have reviewed and enclose herewith the assurance document received
from Versar, Inc. dated April 26, for the EPA project on "Retention of
Liquids on the Surface of Hands", Dr. Thomas C. Voice, project Director.
To assist in your determination of acceptability for conformance of the
assurance with the requirements of HHS regulation 45 CFR 46 on protection
of human reseach subjects by the Environmental Protection Agency we offer
the following comments.
We note that test materials may include a "water soluble dye" without
specification of composition/ source or concentration. Since some water
soluble dyes are toxic, such tests should be limited to dyes approved by
the FDA for coloring foods, drugs or cosmetics or similar uses. Further-
more, if dyes are to be used in any tests with subjects, the consent pro-
cedures should include such information.
Even though the risks in these tests appear to be remote, HHS would
request the addition of at least one IRE member or consultant to the IRE
who (preferably) is a medical specialist in dermatology, or who has sci-
entific competency (Ph.D. or equivalent) in physiology, biochemistry,
pharmacology or toxicology.
These matters have been discussed with Dr. Voice and revised assurance
documents will be sent directly to you. A copy of regulation 45 CFR 46 is
enclosed. Annual certification of IRB review to EPA should be made, if
applicable; several copies of form HHS 596 that may be used for certifica-
tion are also enclosed. If you have questions or feel we can assist you
further, let us know.
Since
Charles R. Mackay, Ph.DV
Deputy Director,
Office for Protection from
Reseach Risks
cc: Dr. Thomas C. Voice, Versar, Inc.
38
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
MAY 25 G83
OFFICE OF
RESEARCH AND DEVELOPMENT
SUBJECT: Project on "Retention of Liquids on
;of Hands"
the
FROM:
TO:
>. Cortes i
:ting Director
Office of Health Research (RD-683)
Michael A. Callahan
Project Officer and Chief
Exposure Assessment Branch (TS-798)
We in the Office of Health Research have reviewed this study and
find it to be in compliance with EPA Order 1000.17, Policy and Procedures
for Protection of Human Subjects in Research, assuming incorporation of
the comments in Dr. Mackay's letter to you of May 5, 1983.
cc: Patricia Thomaier (OA/CMD/RTP)
39
-------
June 17, 19B3
Dr. Hell Jur1nsk1
Nuchemco Inc.
9321 Rain Tree Road
Burke, Virginia 22015
Dear Dr. JuMnskl:
I am enclosing the following material pursuant to our telephone
conversation on Oune 15, 1983, regarding your review of our use of human
subjects In the research study "Retention of Liquids on the Surface of
Hands."
1) Research Work Plan
2) Human Subject Consent Form and Research Summary
3) Compliance Statement
4) Minutes of 1RB Meeting
5) 45 CFR 46 Protection of Human Subjects
6) May 5, 1983 letter from Dr. Mackay of NIH reviewing the project
7) May 25, 1983 memorandum from R.S. Cortes 1 of EPA reviewing the
project.
All of the methodology changes suggested 1n the review process have
been Incorporated Into the work plan at this time. I have been Informed
that a brief written review by you will be sufficient to address
Dr. Mackay's request for an additional IRB member.
Your comments should be sent directly to:
Michael A. Callanhan. Chief
Exposure Assessment Branch
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
401 M Street. S.W.
Washington, O.C. 20460
Your Invoice to Versar should reference project 715.56.
Please do not hestltate to call me at 642-6759 should any question
arise. Thank you, In advance, for your assistance 1n this matter.
Sincerely,
VERSAR INC.
40
Thomas C. Voice, Ph.D.
Staff Research Engineer
Applied Chemistry Division
-------
(N) NuCHEMCO, INC.
24 June 1983 ' INDUSTRIAL HYGIENE. ENVIRONMENTAL. AND CHEMICAL SERVIC
Michael A. Callanhan, Chief
Exposure Assessment Branch
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, O.C. 20460
Subject: Versa r Project "Retention of Liquids on the Surface of Hands"
Dear Mr. Callanhan:
I have been requested by Dr. Thomas C. Voice, Principal Investigator, Versar,
Inc., to provide assistance to the Institutional Review Board of Versar
(Springfield, VA). I have enclosed with this letter a copy of my brief resume
for your files. You will see that I am active 1n the field of heal-th effects
of chemical materials on humans, and employed full-time in the areas of
toxicology and Industrial hygiene. Ny comments relative to the proposed
experimental work of this project follow.
A work plan of April 25, 1983, entitled "RETENTION OF LIQUIDS ON THE SURFACE
OF HANDS" was reviewed from the context of whether the proposed work plan
posed significant Identifiable health risks to the research participants, amd
whether the work was 1n any way Inconsistent with the Intent of the governing
regulations, 45 CFR 46. Also reviewed 1n addition to the work plan and the
regulations, were the documents entllted VERSAR INC. Human Subject Consent
Form (undated), Research Summary (undated), and VERSAR INC. Assurance of
Compliance with HHS Regulations for Protection of Human Research Subjects.
The work plan Indicates that test subjects hands will be Immersed to the
wrists 1n several liquids. The liquids proposed for use [heavy mineral oil,
light cooking oil, watersoluble oil, oil/water emulsion (50:50), water,
water/1 sopropyl alcohol (50:50)] pose no significant health hazard to the test
participants. Other test procedures Involve physical measurements similarly
posing no hazard to the Individuals. There appears to be no cause for concern
regarding any toxic effects that will result from the conduct of the
stipulated tasks of the work plan.
One comment Is made regarding the Human Subject Consent Form. It would be
appropriate to Include either the age or date of birth of subjects to provide
documentation that the subjects are Indeed over the age of 18. I have no
other concerns regarding the conduct of these tests.
Sincerely,
/%*&> $»u*
NeH-B. Ji/rrfnskl, Ph.D., C.I.H.
President v
encl. 41
9321 RAINTREE ROAD . BURKE, VIRGINIA 22015 . (703)978-0642
-------
EDUCATION:
PROFESSIONAL
CERTIFICATION:
NEIL B. JUR1NSKI, Ph.D.
Certified Industrial Hygienist
9321 Raintree Road
Burke, VA 22015
703-978-0642
B.S., State University of New York, Albany, New York, Chemistry, 1960
Ph.D., University of Mississippi, Oxford, Mississippi, Physical Chemistry,
Certified Industrial Hygienist, Comprehensive Practice, American Board c
Industrial Hygiene
Certified Hazard Control Manager, Master Level
International Hazard Control Manager Certification Board
PROFESSIONAL EXPERIENCE:
Private Consultant:
Prior Activities:
President, NuChemCo, Inc., Burke, VA, a small business consulting service
company, specializing in chemical hazard control problems. Provides technic.
consulting services for environmental control, industrial hygiene and toxi
chemical handling and disposal programs. Regular services include a full rang
of industrial hygiene field surveys, development of control techniques fo
chemical carcinogens, and external audits and critiques of on-going health an
safety programs.
Participated in EPA Emergency Response Team efforts for monitoring episode
of airborne toxicants by providing health and safety guidance to team member:
Developed and implemented a comprehensive Health and Safety Program fo
multi-site operations involving chemical carcinogens, addressing both occupa
tional and environmental control.
Developed a system for assessing the extent of worker hazard in laborator
facilities.
Conducted field survey operations to implement industrial hygiene programs
Participated in defining allowable exposure standards for chemical substance
prior to promulgation of OSHA regulations.
Developed Procedures Manual and Personnel Training Program for support c
industrial hygiene field workers.
Supervised analytical chemistry laboratory performing environmental an
industrial hygiene chemistry. Secured AIHA accreditation for laboratory.
Developed sampling and analysis procedures for trace level organic and inorgani
materials.
Provided consultation on sampling, analysis and method development in area
of industrial hygiene, air and water pollution, solid waste disposal, toxicology
biochemistry and data quality.
Developed system description document for laboratory automation via on-lin
data collection to minicomputer CPU, to also handle data processing and repoi
generation.
42
-------
Conducted and participated in training courses in areas of industrial hygiene
and in environmental chemistry.
Taught graduate level courses in aspects of spectroscopy.
Supervised graduate research and thesis programs of Ph.D. and M.S. chemists.
Performed chemical synthesis and surface modification of inorganic products.
Established and supervised applications laboratory in aspects of material flow
conditioning.
Developed analysis methods and studied kinetics and equilibrium of nitroaromatic
explosive compounds in regard to their chemical breakdown products.
Supervised analytical spectroscopy laboratory supporting research program of
a major photo-products company.
PROFESSIONAL MEMBERSHIPS
American Industrial Hygiene Association
American Academy of Industrial Hygiene
American Chemical Society
The Chemical Society (London)
Sigma Xi
American College of Toxicology
American Society of Safety Engineers
43
-------
APPENDIX B
Method for Determining the Surface Area of Hands
44
-------
EXPERIMENTAL MATERIALS
1. Small diameter tracing pen and standard 8-1/2 x 11 white paper
2. Calipers
3. Summa Graphics Micro Grid Model 68XX27 Digitizer
EXPERIMENTAL PROCEDURE
1. Mark opposite sides of hand (wrist) for tracing (these marks estimate the amount of hand
exposed to liquids).
2. Place hand - palm down, fingers spread - on paper.
3. With pen on paper, trace around perimeter of hand and fingers between opposite wrist
marks.
4. Measure perimeter trace, p, with digitizer. The results of these measurements are shown
in Table B-l.
5. Connect side marks with straight line trace.
6. Measure area, S, within closed trace with digitizer. The results of these measurements
are shown in Table B-l.
7. With caliper, measure hand thickness at nine locations: three between the wrist marks,
three midway between the wrist and first knuckles, and one each on the index, ring, and
forefingers between the first and second knuckles. The results of these measurements
are shown in Table B-2.
8. Compute average, t, of the nine hand thickness measurements. The results of these
computations are shown in Table B-2.
QUALITY ASSURANCE
Slightly different experimental procedures were also used to measure subjects' hands, but
all procedures gave surface areas, SA, which differed by no more than the logical error (±
about 5 percent) contained in the cookie-cutter approximation. Thus, all hand measurement
procedures were internally consistent, yielding surface areas the same (± about 5 percent) as
those reported here.
45
-------
I
Table B-l. Hand Perimeter and Area Measurements
Subject:
A
B
C
D
Parameter, P
left
106
90
98
107
(cm)1
right
105
88
99
107
left
170
115
148
168
Area. S (cm2}1
right
164
103
150
163
'Total hand surface area, SA (cm2) = 2'S + p't, where p and S are measured as in the table, and t(cm), the average
hand thickness, is measured as in Table B-2.
46
-------
TtbleB-2. Hind Thickneu Measurements
Thickneu, t (cm)
Measurement location'
Subject/hand:
A/left
right
B/lcft
right
C/left
right
D/left
right
1
35
3.4
3.0
2.9
3.0
2.6
3.4
2.7
2
3.7
3.6
3.2
3.0
3.3
3.2
3.7
3.7
3
2.8
35
2.2
2J
3.0
35
2.6
3.8
4
3.7
3.2
23
2.7
3.0
35
3.3
4.1
5
3.7
35
25
25
3.0
3.0
3.2
4.0
6
3.2
3.3
2.1
2.1
2.4
25
2.5
3.2
7
1.4
1.3
13
1.3
15
15
1.3
1.3
8
15
1.4
1.4
1J
1.6
15
1.4
1.2
9
1.4
1.1
13
1.1
1.4
1J
1.3
15
Avenge
value
2.8
2.7
2.1
2.1
2.5
25
25
2.8
1 Measurement locations:
4- mirror inugc for
light hand
47
-------
APPENDIX C
Liquid Density and Viscosity Measurements
48
-------
To ensure uniformity of liquid density and viscosity measurements between the two tasks
comprising the experiment:
The density of each liquid was measured at room temperature by Gascoyne
Laboratories using a Bingham Pyncnameter following ASTM Method D4052-86, and
The viscosity of each liquid was measured at room temperature by Gascoyne
Laboratories using a Cannon-Fenske viscometer following ASTM method D445.
The results of these measurements are shown in Tables C-l, C-2, and C-3.
49
-------
Table C-l. Mineral 011
Baltimore. MD 21224-6697
REPORT OF ANALYSIS
BA
(3
Report No. 88-06-133
Report To: Versar, Inc
Sample I.D. Mineral Oil
Report Date: June 15, 1988
Page: 1 of 3
Parameter
Viscosity @ 23° C
Specific Gravity
-------
Table C-2. Cooking on
Baltimore. MO 21224.6697
REPORT OF ANALYSIS
BALTIMORE. M:
(301) 2B5-8S1C
SALISBURY MC
(3011543-105!
Report No. 88-06-133
Report To: Versar, Inc.
Sample I.D. Cooking Oil
Report Dace: June 15, 1988
Page: 2 of 3
Parameter Results
Viscosity @ 23° C 59.2 cSt
Specific Gravity
6 24.5° C 0.920
Detection
Limits
0.1
0.001
Method
ASTM D445
Date Test
Analvst Completed
DM
ASTM D4052-86 DM
06/09/88
06/10/88
51
tory
rector
T> u n
-------
F
Table C-3. Bath 011
Baltimore, MD 21224-6697
REPORT OF ANALYSIS
BAl
(30
S*l
uo
Report No. 88-06-133
Report To: Versar, Inc.
Sample I.D. Bath Oil
Report Date: June 15, 1988
Page: 3 of 3
Parameter
Viscosity @ 23° C
Specific Gravity
@ 24.5° C
Detection
Results Limits
33.3 cSt 0.1
Date 1
Analyst Comtile
0.861
0.001
DM
ASTM D4052-86 DM
06/09/
06/101
52
}
Labor>tory Director
-------
APPENDIX D
Liquid Application/Removal Procedures
53
-------
EXPERIMENTAL MATERIALS
1. Experimental liquids: mineral oil, cooking oil, bath oil
2. One-gallon wide-mouth jar
3. PVC gloves
4. 100 percent cotton cloths and plastic holding cups
5. Mettler PC440 laboratory balance (0.01 g accuracy)
6. Liquid hand wash soap (manufactured by Standard Sanitation Systems, Inc.)
7. Water soluble marker
MATERIAL PREPARATION
1. Fill a clean 1-gallon wide-mouth jar approximately half full of the liquid to be studied.
2. Calibrate Mettler PC440 balance with class S weights.
3. Place three clean cotton cloths into separate plastic cups and tare weigh using the
balance. The cups should be labeled and the tare weights recorded. The cloths should
be designated as follows:
a. Application
b. Partial Removal
c. Full Removal
4. Record laboratory relative humidity.
INITIAL WIPE TEST PROCEDURE
1. Fifteen minutes before testing, wash subject's hands with liquid soap for 30 seconds.
Thoroughly rinse hands to remove all soap residue and then dry hands.
2. Mark front and back of subject wrists (where hand begins) with water soluble marker.
3. Wearing PVC gloves, immerse the cloth from the cup labeled "application" into the
liquid and wring the cloth out only enough to stop the dripping. Return the cloth to the
cup and weigh. Record this weight on the data sheet.
4. Immediately instruct the subject to rub the saturated cloth over both hands, front and
back up to the mark, for 30 seconds. At the end of this time, have the subject replace
54
-------
the cloth in the cup and allow any drips from his/her hands to fall into the cup for 30
seconds.
5. Reweigh the application cloth.
6. Have the subject wipe his/her hands lightly for 5 seconds (superficially) with the partial
removal cloth and place it back in the cup.
7. Immediately weigh the partial removal cloth and record the weight.
8. Have the subject wipe their hands as thoroughly and completely as possible within 10
seconds removing as much liquid as possible, using the full removal cloth. Have the
subject replace the cloth into the cup.
9. Immediately weigh the full removal cloth and record the weight.
SECONDARY WIPE TEST PROCEDURE
1. Repeat steps 2 through 9 of the initial wipe test procedure immediately after the initial
wipe test. Record measurements as "secondary" wipe test measurements.
IMMERSION TEST PROCEDURE
1. Same as step 1 for initial wipe test procedure.
2. Same as step 2 for initial wipe test procedure.
3. Have the subject immerse one hand in liquid up to a previously marked spot on the wrist
for 10 seconds. Withdraw the hand and allow it to drip for 30 seconds (1 minute for
cooking oil).
4. Have the subject wipe the hand lightly and quickly with the partial removal cloth for 15
seconds while trying to avoid getting liquid on the other hand. Have the subject return
the cloth to the cup.
5. Immediately weigh the partial removal cloth and record the weight.
6. Immediately have the subject wipe the hand thoroughly and completely with the full
removal cloth for 10 seconds, again trying to avoid getting any oil on the other hand.
Have subject return cloth to cup.
7. Immediately weigh the full removal cloth and record the weight.
55
-------
QUALITY ASSURANCE
Testing was limited to only one oil per day for each subject to elimi-
nate any additive effects that could have been introduced by potentially saturating the skin with
the test oils. The relative humidity was recorded daily to account for any differences in
measurements that could be related to the humidity, such as the absorption of water by cotton.
Weighing errors were minimized by calibrating the balance with class S weights before
each day's experiments, and cloth absorption differences were minimized by obtaining the cloths
from a single source. Subject application/removal technique differences were minimized by
giving clear verbal and written instructions to each participant before beginning experiments, and
subject hand condition differences were minimized by using a standard hand washing procedure
before each initial wipe and immersion test.
56
-------
APPENDIX E
Data Tables: Amount of Liquid Retained on the Surface
of Hands, Wipe and Immersion Tests
57
-------
Table E-l. Arount of Liquid Retained on the Surface of Hands
. Vlpe Testa >
Mineral oil
Initial wipe
Secondary wipe
Cooking oil
Initial Mtpe
Secondary wipe
Bath oil
Initial wipe
Secondary wipe
Experimental
subjects:
in
oo
A 1.47,
1.68.
1.57.
1.73.
B 1.32.
1.27.
1.22.
1.32.
C 1.26.
1.11.
1.02.
1.41.
D 1.78.
0.87.
1.19.
1.49.
0.63.
0.86.
0.75.
0.79.
0.56.
0.47.
0.49.
0.77.
0.29.
0.31.
0.24.
0.70.
0.84.
-0.02.
0.30.
0.89.
1.41
0.40
0.41
0.13
0.30
0.26
0.31
0.10
0.13
0.12
0.08
0.11
0.24
-0.38
0.10
0.14
1.36.
1.34.
1.28.
1.36.
1.09.
1.16.
1.21.
1.33.
1.12.
1.02.
1.05.
1.25.
1.37.
1.17.
1.14.
1.23.
0.61. 0.15
0.40. 0.02
0.29. -0.07
0.54. 0.03
0.47. 0.23
0.46. 0.12
0.44. 0.16
0.71. 0.10
0.12. -0.03
0.13. -0.02
0.20, 0.05
0.62. 0.03
0.40. 0.03
0.40. -0.02
0.30. 0.08
0.50. -0.07
4.35.
3.07.
2.93.
1.86.
1.94.
1.52.
1.77.
1.92.
2.31.
2.56.
2.25.
1.55.
1.25,
1.13.
1.05.
1.65.
1.46.
0.85.
1.42.
0.88.
0.61.
0.45.
0.65,
1.03.
0.77.
OJ77.
0.56.
0.61.
0.46.
0.34.
0.32.
0.74.
0.92
0.52
0.86
0.23
0.27
0.15
0.21
0.17
0.56
0.44
0.26
0.17
0.14
0.08
0.05
0.06
3.37.
2.69.
2.14.
1.60.
1.61.
1.48.
1.32.
1.50.
1.95.
1.84.
1.99.
1.31.
1.09.
1.09.
0.97.
1.48.
0.86.
0.76,
0.30.
0.68.
0.49.
0.48.
0.41.
0.81.
0.49.
0.32.
0.34.
0.51.
0.25.
0.25.
0.22.
0.53.
0.61
0.06
-0.36
-0.02
0.17
0.08
0.03
0.06
0.62
-0.09
0.01
0.02
-0.11
-0.10
-0.11
-0.06
2.00.
1.89.
1.99.
1.83.
1.73.
1.56.
1.54.
1.52.
1.15.
1.14.
1.16.
1.49.
0.99.
1.01.
1.05.
1.82.
0.64.
0.58.
0.78.
0.87.
0.67.
0.49.
0.58.
0.89.
0.27.
0.25.
0.28.
0.69.
0.34.
0.32.
0.34.
0.17.
0.30
0.06
0.37
0.16
0.38
0.31
0.31
0.16
0.17
0.12
0.11
0.13
0.08
0.10
-0.02
0.00
1.59.
1.71.
1.52.
1.43.
1.32.
1.84.
1.46.
1.50.
1.02.
1.14.
1.12.
1.19.
0.97.
1.00.
0.97.
1.64.
0.43.
0.30.
0.46.
0.55.
0.31.
0.79.
0.35.
0.77.
0.22.
0.26.
0.25.
0.48.
0.27.
0.29.
0.23.
0.59.
0.05
0.04
-0.06
0.02
0.14
0.51
0.14
0.15
0.01
0.11
0.07
-0.04
0.13
0.02
-0.03
-0.12
* Table trlpiet entries - amount retained after application, amount retained after partial removal, amount retained after full removal.
The first three replicates for each subject, oil. and test are fro* experiment three meaarummts; the last replicate is fro* experiment two
Measurements.
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Table E-2. Amount of Liquid Retained on the Surface of Hands (mg/cm2), Immersion Test1*2
Mineral oil
Cooking oil
Bath oil
Experimental
subjects:
A
B
C
D
11.92, 1.98
12.46, 1.58
12.50, 1.82
11.35, 3.10
11.22, 3.65
11.97, 3.37
9.17, 1.19
10.09, 0.85
10.04, 0.95
8.67, 2.61
9.13, 1.69
9.25, 1.91
9.24, 0.81
9.89, 0.53
10.04, 0.61
9.51, 2.76
9.19, 2.25
9.32, 1.91
10.34, 0.60
10.66, 0.81
9.62, 0.63
10.97, 2.36
10.91, 2.27
10.56, 1.80
6.42, 1.32
7.20, 1.61
6.75, 1.62
6.68, 2.64
6.70, 2.41
6.68, 2.22
6.52, 0.54
7.10, 0.57
6.98, 0.66
4.90, 2.31
4.92, 1.65
5.31, 1.87
4.62, 0.67
4.90, 0.73
4.88, 0.69
4.61, 1.69
5.10, 1.71
5.08, 1.41
7.60, 1.02
6.13, 0.50
7.26, 0.52
6.05, 1.34
6.04, 1.36
6.07, 1.09
6.60, 0.75
6.61, 0.88
6.65, 0.57
6.17, 1.68
6.64, 2.26
7.11, 2.79
5.53, 1.39
3.46, 3.24
5.56, 0.78
5.01, 1.60
5.57, 1.52
5.76, 1.67
5.43, 0.59
5.43, 0.59
5.55, 0.57
5.24, 1.90
5.49, 2.31
5.11, 1.43
6.42, 0.54
6.16, 0.63
6.44, 0.71
6.90, 1.20
7.25, 1.12
6.49, 1.41
1
Table doublet entries = amount retained after application, amount retained after partial removal.
2 The first three replicates for each subject and oil are from experiment three measurements; the last three replicates are
from experiment two measurements.
59
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APPENDIX F
ANOVA Tables: Amount of Liquid Retained on the Surface
of Hands, Wipe and Immersion Tests
60
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Table P-l. ANOVA Statistics for Amount of Liquid Retained on the Surface of Hands after Application, Wipe Tests
Factor
Subject, S1
Liquid, 1?
Test, T3
SxL4
SxT5
LxT6
S x L x T7
Error
Degrea of
freedom
DP
3
2
1
6
3
2
6
72
Sum squares
SS
7.485
6.443
1.133
4.864
0.367
0.247
0.080
7.671
Mean square
MS-SS/DF
2.495
3.221
1.133
0.811
0.122
0.124
0.013
0.106
Variance ratio
F-MS/MSE*
23.42
30.23
10.63
7.61
1.15
1.16
0.12
1.00
J6jonific.ftn£f
probability
>0.99
>0.99
>0.99
>0.99
1 Subject factor levels » A, B, C, D.
2 Liquid factor levels - mineral oil, cooking oil, bath ofl.
3 Test factor levels m initial wipe test, secondary wipe test
4 Subject-Liquid interaction.
5 Subject-Test (Application/Removal) interaction.
6 Liquid-Test interaction.
7 Subject-Liquid-Test interaction.
° Larger variance ratios indicate larger mean squares (variances) caused by specific factors relative to the common error
mean square, MSE, caused by random variations. Thus, the larger the variance ratio, the larger is the variability due to
specific factors relative to the variability due to common random factors, and so the more significant (a source of
variability) is the factor with which the ratio is associated.
61
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Table F-2. ANOVA Statistics for Amount of Liquid Retained on the Surface of Hindi after Partial Removal, Wipe Tests
Factor
Subject, S1
Liquid, L
Test, T3
SxL4
SxT5
LxT6
S x L x T7
Error
Degrees of
freedom
DF
3
2
1
6
3
2
6
72
Sum squares
SS
1.665
0.452
0.652
0.377
0.377
0.121
0.029
1.781
Mean square
MS=SS/DF
0.555
0.226
0.652
0.063
0.112
0.061
0.005
0.025
Variance ratio
F=MS/MSE8
22.44
9.14
26.35
2.54
4.54
2.44
0.19
1.00
Significance
probability
>0.99
>0.99
>0.99
>0.95
>0.99
1 Subject factor levels = A, B, C, D.
2 Liquid factor levels = mineral oil, cooking oil, bath oil.
3 Test factor levels = initial wipe test, secondary wipe test.
4 Subject-Liquid interaction.
5 Subject-Test (Application/Removal) interaction.
6 Liquid-Test interaction.
7 Subject-Liquid-Test interaction
* Larger variance ratios indicate larger mean squares (variances) caused by specific factors relative to the common error
mean square, MSB, caused by random variations. Thus, the larger the variance ratio, the larger is the variability due to
specific factors relative to the variability due to common random factors, and so the more significant (a source of
variability) is the factor with which the ratio is associated.
62
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Table F-3. ANOVA Statistics for Amount of Liquid Retained on the Surface of Hands after Pull Removal, Wipe Tests
Factor
Subject, S1
Liquid, L2
Test.T3
SxL4
SxT5
LxT6
S x L x T7
Error
Degrees of
freedom
DP
3
2
1
6
3
2
6
72
Sum squares
SS
0.829
0.076
0.807
0.454
0344
0.100
0.103
2.057
Mean square
MS-SS/DF
0.276
0.038
0.807
0.076
0.181
0.050
0.017
0.029
Variance ratio
F-MS/MSE8
9.67
1.33
28.24
2.65
6.35
1.75
0.60
1.00
Significance
probability
>0.99
>0.99
>0.95
>0.99
1 Subject factor levels » A, B, C, D.
2 Liquid factor levels « mineral oil, cooking oQ, bath oil
3 Test factor levels initial wipe test, secondary wipe test.
4 Subject-Liquid interaction.
5 Subject-Test (Application/Removal) interaction.
6 Liquid-Test interaction.
7 Subject-Liquid-Test interaction
8 Larger variance ratios indicate larger mean squares (variances) caused by specific factors relative to the common error
mean square, MSE, caused by random variations. Thus, the larger the variance ratio, the larger is the variability due to
specific factors relative to the variability due to common random factors, and so the more significant (a source of
variability) is the factor with which the ratio is associated.
63
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Table F-4. ANOVA Statiitici for Amount of Liquid Retained on the Surface of Handi after Application, Immersion Test
Factor
Subject, S1
Liquid, L2
SxL3
Error
Degrees of
freedom
DF
3
2
6
60
Sum squares
SS
40.11
303.98
7.59
16.49
Mean square
MS-SS/DF
13.37
151.99
1.27
0.27
Variance ratio
F-MS/MSE4
48.60
552.90
4.60
1.00
Significance
probability
>0.99
>0.99
>0.99
1 Subject factor levels «= A, B, C, D.
2 Liquid factor levels = mineral oil, cooking oil, bath oil.
3 Subject-Liquid interaction.
4 Larger variance ratios indicate larger mean squares (variances) caused by specific factors relative to the common error
mean square, MSE, caused by random variations. Thus, the larger the variance ratio, the larger is the variability due to
specific factors relative to the variability due to common random factors, and so the more significant (a source of
variability) is the factor with which the ratio is associated.
64
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Table F-5. ANOVA Statistics for Amount of Liquid Retained on the Surface of Hands after Partial Removal,
Immersion Test
Factor
Subject, S1
Liquid, L2
SxL3
Error
Degrees of
freedom
DP
3
2
6
60
Sum squares
SS
8.07
2.79
2.62
10.78
Mean square
MS-SS/DF
2.69
1.39
0.44
0.18
Variance ratio
F-MS/MSE4
14.97
7.76
2.43
1.00
Significance
probability
>0.99
>0.99
>0.95
1 Subject factor levels * A, B, C, D.
2 Liquid factor levels * mineral ofl, cooking oil, bath oE.
3 Subject-Liquid interaction.
4 Larger variance ratios indicate larger mean squares (variances) caused by specific factors relative to the common error
mean square, MSB, caused by random variations. Thus, the larger the variance ratio, the larger is the variability due to
specific factors relative to the variability due to common random factors, and so the more significant (a source of
variability) is the factor with which the ratio is associated.
65
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