United States
                    Environmental Protection
                    Agency
 Health Effects
 Research Laboratory
 Research Triangle Park NC 27711
                     Research and Development
 EPA-600/S1-84-023 Jan 1985
&EPA         Project Summary
                    Chromosome  Studies  on  Human
                    Subjects  Exposed  to  Arsenic  in
                    Drinking Water
                     Baldev K. Vig
                      A 2-year  study was carried out on
                    human subjects of various ages and
                    backgrounds who have been drinking
                    water containing 0.05 mg/l (0.05
                    ppm) or more arsenic for a period of at
                    least 5 years. A control group that had
                    been exposed to arsenic in drinking
                    water at concentrations less than 0.05
                    mg/l was used for some aberrations
                    and sister chromatid exchanges in the
                    lymphocytes of the two  populations
                    with the amount of arsenic in the water
                    they have been drinking. A questionnaire
                    was designed to explore the incidence
                    of skin  cancer, fetal wastage,  any
                    genetic development abnormalities in
                    the family  and  related parameters.
                    Several other variables, e.g., coffee,
                    wine and cigarette consumption, sex,
                    residence (rural vs. urban) and exposure
                    to chemicals, smelter  and pesticides
                    were taken  into  consideration. The
                    study involved the city of and areas in
                    the vicinity of Reno, Nevada.

                      This study on chromosome aberrations
                    (104 exposed and 86 control individuals)
                    and on sister chromatid exchanges (98
                    exposed and 83 control individuals) did
                    not show that arsenic at a mean level of
                    0.109 mg/l has any effect on these
                    parameters.  Similarly,  no effect  of
                    arsenic at these modest concentrations
                    was found on other health parameters
                    studied.

                      This Project Summary was developed
                    by EPA's Health Effects Research
                    Laboratory. Research Triangle Park. NC,
                    to announce key findings of the research
                    project that  is fully documented in a
                    separate  report of the same title (see
                    Project Report ordering information at
                    back).
 Introduction and Summary
  Inorganic arsenicals have been impli-
 cated in  several  health problems  A
 partial  list includes skin-cancers, liver
 cirrhosis, gastrointestinal catarrh, hyper-
 keratosis, polyneuntis, and genetic
 damage.  Many parts of the  United
 States contain rather high quantities of
 inorganic arsenicals in their drinking
 water, especially obtained from under-
 ground deposits Considering the results
 from several different studies mostly of
 non-U S  origin,  the  United  States
 Environmental Protection Agency (EPA)
 set "Interim Drinking Water Regulations"
 in 1976which requirethat drinking water
 contain less  than 0.05 mg/l of total
 arsenic
  In the meanwhile, the EPA has initiated
 an extensive research program to assess
 health effects in relation to various levels
 of arsenic in drinking water. Recent  in
 vitro experiments and study of lymphocytes
 of patients treated for psoriasis with
 arsenic containing compounds have
 shown  that arsenic induces genetic
 damage Furthermore, a strong correla-
 tion exists between carcinogenic and
 mutagenic potentials, especially induction
 of Sister Chromatid Exchanges (SCEs), of
 chemicals With this in view, a study was
 initiated m 1978  to  find out  if any
 increase in the frequency of chromosome
 aberrations and SCEs  is evident in  a
 population  drinking water containing
0 05 mg/l or higher arsenic in comparison
to a population drinking water containing
 less than 0 05 mg/l arsenic
  The study centered around the city  of
Reno and encompassed some neighboring
communities, viz. Hidden Valley,  Fallen,
Virginia Foot Hills,  and Fernley Most  of
the residents of Reno had been drinking

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water containing an average of 0 01 +
0 001 mg/l of arsenic (range <0.005 to
0.045 mg/l) and thus served as control
group. Those of other communities,
especially Fallen — 50 miles NE of Reno
— have  an  average  of 0 109  + 0.005
mg/l of  arsenic  (range  0.05 to 0 39
mg/l) in  drinking water  One  individual
had  been drinking water  with  2  275
mg/l arsenic  but was not  included in
further statistical analysis  This group
served as the "exposed" population or
"cases."  In order to  be included in the
study as  control the subject  was to have
been drinking water containing  <0 05
mg/l arsenic for  at  least 5 years,  and
similarly  >0.05 mg/l  arsenic for 5 years
to be included as "exposed."
   A questionnaire was designed to obtain
data on the following: sex, ethnic origin,
age, occupation, exposure to  pesticides
and other chemicals, water quality and
quantity food and drinking habits,
smoking, health status including pains,
liver and kidney disease, nerve disorders,
arthritis, cancer or ulcers, anemia, bone
problems, hair,  nail or weight loss,
hyperpigmentation  of skin, nausea,
menstrual irregularities, stillbirths,
miscarriages and  pregnancy  complica-
tions A  telephone call was used for the
first contact and  participation  was
entirely voluntary The questionnaire was
completed by personal interview. At that
time a water sample from the kitchen tap
was obtained to analyze arsenic content
A 5-ml  blood sample was  obtained for
chromosome studies.
   The arsenic content of water  was
analyzed by  the Nevada  State  Health
 Laboratory using atomic absorption  as
well as by colometric  technique Chromo-
some preparations were  carried out  by
culturing whole blood  in  medium 1A
(GIBCO)for48 to 72  hours  ForSCEsthe
cells were  treated with BrdU for two
rounds of replication. Routine colcemid,
 hypotonic treatments  were used for
 harvesting  Giemsa  stain was used on
 slides used for chromosome aberrations
 and f luoresent plus giesma technique for
 SCE analysis.  Attempts  were made  to
 analyze  up to 200 cells for various types
 of aberrations (gaps, breaks,  exchanges
 or chromatid and chromosome type) and
 at least 25 cells for SCE analysis). Quality
 control was always  exercised to assure
 reproducibility of results of  all  studies.
   A total of 211 cases were included in
 the study. The population samples in the
 control  and  exposed groups  expressed
 considerable, though not perfect,  simi-
 larities in life style Relevant information
 for  the control (86 volunteers) and
 "exposed" (105 volunteers) populations,
respectively, are as follows age in years =
29 56  + 15 vs. 42 20 + 1 6;  water
consumed (glasses per day) = 4 35 +02
vs. 5.1 2 + 1.6; coffee consumed (cups per
day) = 3.30 + 0.4 vs. 4.09 ± 0.3; % males =
58 1  vs. 58.3, % exposed to pesticides =
7 0 vs 9 5; % exposed to smelter - 1.2 vs
2 9; % exposed to chemicals = 1 2 vs  29;
% cigarette smokers = 16.3 vs  15 2, %
wine drinkers = 25.6 vs 12.4; % residents
of rural Nevada =31 4 vs. 92.4. Statistical
analysis of the  control vs.  exposed
population showed no significant differ-
ences with respect to sex, exposure to
pesticides, smelter, chemicals or smok-
ing   However,  there were  more wine
drinkers  among control than exposed
individuals (X2 =4.66 on Idf, p =0.03) and
more exposed  individuals  came from
rural than urban sample(x2= 74 56 on Idf,
p<0.001)  The mean  age of the control
group (29.6 years) was also significantly
(p<0.001) less than that of the exposed
group  (42 2 years).  The mean water
consumption or  coffee consumption  was
not significantly different.
  For various reasons, only 191  cases
were found suitable for the two types of
cytogenetic analysis. Of these,  190
cultures used for analysis of chromosome
aberrations were derived from 86 control
and 104 exposed volunteers Two hundred
cells per  individual  were analyzed in
every case except for 16 cases. The study
of SCEs was based on a sample size of
181  individuals, 83 in control group and
98 in the exposed. A sample of 50 cells
per case was analysed for SCEs for the
first  62  cases  and 25  cells  per  case
thereafter.

Results
  A total of 18,240 cells were studied for
chromosome aberrations among the 86
control individuals and 19,264 cells from
the lymphocytes  of 104  exposed.  The
frequency of chromosome aberrations  in
the entire population  studied ranged
between 0.00 to  0.13 aberrations/cell,
with a mean of 0.033+0.002 aberrations/
cell in the control population and 0.026 +
0.002  aberrations/cell in  the  exposed
group. The frequency of aberrations,
though lower in the exposed population
than the control, is none-the-less within
normal range for both The frequency of
SCEs,  however, was similar in the  two
groups. The range for the entire group
was 5.84 to 15.28  SCEs/cell  with an
average of 8.301 +  0113/cell for the
control group and 8.306 + 0.141 /cell  in
the exposed group.
  Detailed information on  multiple
regression analysis of  chromosome
aberrations and  SCEs as  function  of
arsenic exposure and other independent
variables is provided in Table 1.
  Statistical interpretation of the data
showed that the six multiple regressions
using chromosome  aberrations  as a
dependent variable were all significant,
with 109%-13.0% of the variance being
explained  by the  10 independent vari-
ables as a group. The urban population
sample showed significantly higher aber-
ration frequency than the rural group
There was also some indication that cof-
fee consumption may increase the fre-
quency of chromosome aberrations.
However,  arsenic exposure showed no
relationship  with  chromosome  aberra-
tions in our sample.
  Using SCE as a dependent variable, all
the six multiple regressions were statis-
tically significant  However, only 11.1-
13.6 percent of the total variance in SCE
was explained by the  10 independent
variables as a group Specifically, smokers
exhibited more SCEs than non-smokers
However, arsenic concentration in drink-
ing water  showed no effect on the fre-
quency of SCEs
  The average arsenic content in the
exposed group in this study is more than
twice (exactly 218%) of the highest limit
mandated by the EPA. The quantity of
water consumed is  also higher for the
exposed populations since most of it was
derived from farming communities in
rural Nevada The mean  age of the
exposed group is also higher than that of
the control (p<0.001), which may dispose
the exposed group to higher frequency of
chromosome aberration In spite of these
factors,  our data do not show an  in-
creased incidence of chromosome aber-
rations or SCEs in the population exposed
to  modest  quantities  of arsenic in
drinking water

Conclusions
  These studies show that arsenic when
consumed in modest quantities (at least
up to 0.1 mg/l) in drinking water for up to
5 years does  not appear to cause any
detectable increase  in the frequency of
chromosome aberrations or SCEs in the
lymphocyte cultures Besides, m the
limited population surveyed no evidence
of increased  incidence of other serious
health effects were observed.

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Table 1.    Summary of Multiple Linear Regression Analyses of Chromosome Aberrations and Sister Chromatid Exchanges as Functions of Arsenic Exposure
          and Other Independent Variables
Dependent
Variable

SCE





ARSENIC

061


057


Standardized Regression Coefficients for Independent Variables'
ARSGRP


052


054

ARSWAT



163+


164+
SEX

-097
-098
- 102
-093
-094
-097
AGE

047
049
052
044
044
046
PEST

- 119
- 114
- 136
- 117
- 112
- 134
SMELT

002
007
010
006
011
014
CHEM

-043
-046
-046
-050
-052
-052
COFFEE

151
149
157



LOGCOFF WINEGRP CIGSGRP

030 168+
031 167+
011 170+
129 025 183+
129 026 181 +
139 006 185+
C/TYGRP

134
134
171
129
133
169
F> r'
{For overall
regression!
223+ HO
2 21+ 111
2 65' 13 1
2 12+ 110
211+ 110
255* 130
 CRABNOR   -013                      -003     026    035     057    -066     162+             -058      065      316"    262*     12 8
                      -007             -003     025    033     056    -066     163+             -058      065      319*    262*     128
                                040    - 004     023    027     057    - 065     164+             - 062      067      339*    2 65*     13 0
             -018                       009     067    030     070    -068              028     -042      110      311*    218+     109
                      -006              009     065    028     069    -067              028     -042      111      317*    217+     109
                                033     008     063    023     070    -066              029     -045      113      334*    219+     110
ORABLOG -014
-043

-017
-043



020


016
-020
-021
-020
-013
-014
-013
-010
-O07
-013
014
017
010
059
057
054
056
054
052
096
094
095
103
102
103
-071
-072
-070
-072
-072
-071
092
092
093






014
013
015
-062
-063
-063
-052
-054
-053
041
040
043
068
067
069
281*
263*
296*
278
262
293
1 94+
1 96+
1 95+
1 81
1 83
1 81
98
99
98
92
93
92
 'Significance levels indicated as follows + -0 01 
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     Baldev K. Vig is with the University of Nevada, Reno, NV 89557.
     Daniel G. Greathouse is the EPA Project Officer (see below).
     The complete report, entitled "Chromosome Studies on Human Subjects Exposed
       to Arsenic in Drinking Water, "(Order No. PB 85-125 821; Cost: $10.00, subject
       to change) will be available only from:
             National Technical Information Service
             5285 Port Royal Road
             Springfield, VA 22161
             Telephone: 703-487-4650
     The EPA Project Officer can be contacted at:
             Health Effects Research Laboratory
             U.S. Environmental Protection Agency
             Research Triangle Park, NC 27711
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