SERA
                               United States
                               Environmental Protection
                               Agency
                                Health Effects Research
                                Laboratory
                                Cincinnati OH 45268
                              Research and Development
                               EPA-600/S1-81-009 Apr 1981
Project Summary
                               Investigation  of Effects of
                               Prolonged  Inhalation  of
                               Nickel-Enriched  Fly  Ash  in
                               Syrian     Golden    Hamsters
                              Alfred P. Wehner
                               Groups of 102 Male Syrian Golden
                              hamsters were chronically exposed to
                             ~~70 /yg/l respirable Nickel Enriched
                              Fly Ash aerosol (high NEFA group),
                             —17 /jg/\ (low NEFA group), or —70
                             /jg/\  FA 6 hrs/day, 5 days/week for
                              up to 20 months. An identical control
                              group received sham exposures. The
                              NEFA particles of  respirable size
                              contained approximately 6% nickel,
                              compared to about 0.3% for FA. Five
                              hamsters/group were sacrificed after
                              4,8,12, or 16 months of exposure. An
                              additional 5 hamsters/group were
                              withdrawn from exposure at the same
                              intervals for lifelong observations.
                               Exposures  to  NEFA had  no
                              significant effect  on the apparent
                              well-being, body weight and life span
                              of the  animals  although   heavy
                              deposits of NEFA in  the lungs were
                              demonstrated. The lung weights of
                              the high NEFA-and of the FA-exposed
                              animals, however, were significantly
                              (P<0.01)  higher than those  of low
                              NEFA controls.  There was  no
                              significant difference between the
                              mean body weights of the high NEFA
                              group and the FA group. The mean
                             'lung   volumes were  significantly
                              (P<0.01)  larger for the high  NEFA
                             group and the FA group than for the
                              low NEFA group and the controls.
                                There was a 100% incidence of dust
                               deposition, referred to in this report as
                               anthracosis, in the lungs of exposed
                               hamsters. Incidence and severity of
                               interstitial reaction and bronchioliza-
                               tion were significantly  higher in the
                               dust-exposed  groups  than in  the
                               sham-exposed controls. The severity
                               of  anthracosis,  interstitial reaction
                               and bronchiolization was significantly
                               lower (P<0.01) in the low NEFA group
                               than in the high NEFA and FA groups.
                               This dose-effect  relationship reflects
                               the two different dose groups, namely
                               low NEFA versus high NEFA and FA.
                               While two malignant primary thorax
                               tumors were found in two hamsters of
                               the high NEFA group, no statistically
                               significant carcinogenesis  was
                               observed.  Of the  exposure-related
                               changes, only anthracosis decreased
                               as a function of recovery time.
                                Comparison of pulmonary  nickel
                               burdens after 20  months of exposure
                               with the  aerosol  concentration
                               suggests  that  the  pulmonary
                               clearance rate was slower in the high
                               NEFA exposure group than in the low
                               NEFA exposure group.
                                The results of this study lead to the
                               conclusion that the addition of nickel
                               to fly ash under  these  experimental
                               conditions did  not significantly

-------
(P<0.05) enhance the pathogenicity
(including carcinogenicity) of fly ash in
this animal model.
  This  Project Summary  was
developed  by EPA's Health Effects
Research Laboratory, Cincinnati, 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
  Clinical,  epidemiological  and
laboratory studies implicate nickel and
certain  of  its  compounds   as  an
environmental health hazard. Exposure
of the general population to nickel
occurs mainly through the inhalation of
fly ash. Fly ash is a combustion product
of coal and fuel oil. It is discharged into
the atmosphere at an estimated rate of
several million metric tons per year in
the United States This quantity  of fly
ash contains several thousand tons of
nickel. Because of  its known toxicity
and presence in fly ash, it was desirable
to investigate whether nickel in fly ash
is an important etiological factor. This
was accomplished by enriching regular
fly   ash   with  nickel  and   exposing
hamsters  to  nickel-enriched  fly ash
(NEFA) or to regular fly ash  (FA) and
comparing the  findings to those in
sham-exposed  controls.  NEFA   was
prepared by mixing  nickel  acetate into
pulverized coal before combustion in a
special fossil fuel furnace and collecting
the fly ash generated in  the process.
  A pulmonary deposition, transloca-
tion and clearance study with neutron-
activated fly ash to determine the fate of
the inhaled fly ash in the animals, and
an   Ames   assay to  determine
mutagenicity complemented  the
inhalation study.
 Results and Conclusions
  Exposure to NEFA had no significant
 effect on the apparent well-being, body
 weight  and life span of the  animals,
 although heavy deposits of NEFA in the
 lungs  were  demonstrated. The lung
 weights of the high  NEFA- and of the
 FA-exposed  animals,  however,  were
 significantly (P<0.01) higher than those
 of the low NEFA group and the controls.
 There  was  no  significant difference
 between the MBWs  of the high NEFA
 group and the FA group. The mean lung
volumes  were  significantly (P<0.01)
larger for the high NEFA group and the
FA group than for the low NEFA group
and controls.
  There was a 100% incidence of dust
deposition, referred to in this report as
anthracosis,  in the  lungs  of exposed
hamsters. Incidence and  severity of
interstitial reaction and bronchiolization
were  significantly higher in the dust-
exposed  groups than  in  the  sham-
exposed   controls.  The  severity  of
anthracosis,   interstitial  reaction and
bronchiolization was significantly lower
(P<0.01) in the low NEFA group than in
the high  NEFA  and FA groups. This
dose-effect relationship reflects the two
different dose groups, namely low NEFA
versus high  NEFA and  FA. While two
malignant primary thorax tumors were
found in two hamsters of the high NEFA
group,  no  statistically significant
carcinogenesis  was observed.  Of the
exposure-related  changes, only
anthracosis decreased as a function of
'recovery time.
  Comparison  of  pulmonary  nickel
burdens after 20 months of exposure
with the aerosol concentration suggests
that the pulmonary clearance rate was
slower in the high NEFA exposure group
than in the low NEFA exposure group.
  The results of this study lead to the
conclusion that the addition of nickel to
fly  ash   under  our  experimental
conditions did not significantly (P<0.05)
enhance  the pathogenicity (including
carcinogenicity) of fly ash in our animal
model.
  The fly ash burden estimates from the
pulmonary  deposition,  translocation
and  clearance  experiment,   as
determined  by the radionuclides 46Sc
and 59Fe, are in good agreement for the
majority  of  samples analyzed. Such
close   agreement  indicates fly  ash
paniculate levels in the lungs, carcass,
head, pelt, Gl tract, and feces  rather
than leached radionuclides. Relative to
the 46Sc and the 59Fe-based estimates,
fly ash deposition estimates obtained
with the isotope 60Co were appreciably
lower for the lungs and  appreciably
higher for one or more sacrifice times
for carcass,  liver, head, pelt and urine
samples. This indicates  that 60Co (and
thus the element cobalt) was selectively
leached from fly ash deposited in the
deep  lung, translocated to other sites,
and excreted in the urine.
  An estimated average of 63 /JQ fly ash,
or 2 to 3% of the inhaled fly ash, was
initially retained in the respiratory tract.
The estimated biological half-times of
the fly ash were 2.6 and 34.5 days,
probably  for the airways and  for the
deep lung, respectively. After 99 days,
the mean lung burden had decreased to
about 10% of its initial value. Estimated
near-complete clearance of fly ash from
the lung would have been  achieved
approximately 200 days postexposure.
  In all Ames  assays  the  responses
were negative. Thus, NEFA and FA  did
not appear to  be  mutagenic  in the
standard Ames assay.  However, this
does  not preclude  the possibility of
demonstrating  mutagenic activity  by
altering the standard Ames test in some
way or by use of different extraction
procedures  to  remove  potential
mutagens from the surface of NEFA and
FA
Materials and Methods
  Based on  the  results of  acute and
subacute toxicity studies described in
this report, groups of 102 male Syrian
golden  hamsters   were  chronically
exposed to —70/yg/l respirable NEFA
aerosol  (high NEFA group), ~17//g/l
(low NEFA group),  or ~70,ug/l FA  6
hrs/day, 5 days/week, for up to 23
months.  An  identical  control  group
received  sham  exposures. The NEFA
particles of  respirable  size contained
approximately 6% nickel, compared to
about 0.3% for FA. Five hamsters/group
were  sacrificed after 4, 8, 12, or 16
months  of exposure. An additional  5
hamsters/group were withdrawn from
exposure  at  the same  intervals foi
observation  until 22  months  of ag€
when all animals were  sacrificed.
  To determine pulmonary deposition
translocation and clearance of  inhalec
fly ash,  hamsters received a single 95
minute nose-only exposure to neutron
activated fly  ash. The mean respirable
aerosol  concentration  was 470 /ug/l
Over a period of 99 days postexposure
the hamsters were sacrificed in group:
of six animals. Lungs,  liver,  kidneys
decapitated and skinned carcass, pell
head, gastrointestinal tract, urine, ani
feces were collected for analysis of th
radionuclide tracers 46Sc,  69Fe, an
60Co, by x-ray spectrometry.
  Dimethylsulfoxide (DMSO) extracts c
NEFA  and  FA  were  tested  fc
mutagenicity  in  the  postmitc
chondrial/'S3/rtW7e//a  (AMES)  assa
with and without metabolic activation
using Aroclor-induced  hepatic enzyrri
preparations as the source of activatir
enzymes.  The total concentration of F

-------
and NEFA in the DMSO solvent  was
about 50 mg per ml. The concentrations
used in the Ames assays of NEFA and
FA ranged from  10 to 5000 /ug per petri
plate.
  The  final  report  submitted to  the
Project Officer also included numerous
computer data sheets dealing with: list
of observations  on individual  animals,
list of animals with lesions; list of inci-
dence of lesions; and list of incidence by
type of tumor. This data  is on file in the
Health  Effects  Research  Laboratory,
26  W.  St. Clair  Street,  Cincinnati, OH
45268.
   Alfred P Wehner is with Battelle Pacific Northwest Laboratories, Richland, WA
     99352.
   Wellington Moore, Jr. and William E. Pepelko are the EPA Project Officers (see
     below)
   The complete report, entitled "Investigation of Effects of Prolonged Inhalation of
     Nickel-Enriched Fly A sh in Syrian Golden Hamsters," (Order No PB81-152514;
     Cost: $14.00, subject to change) will be available only from.
           National Technical Information Service
           5285 Port Royal Road
           Springfield,  V'A  22161
           Telephone. 703-487-4650
   The EPA Project Officers can be contacted at:
           Health Effects Research Laboratory
           U.S. Environmental Protection Agency
           Cincinnati. OH 45268
              i US GOVERNMENT PRINTING OFFICE 1981-757-012/7047

-------
United States
Environmental Protection
Agency
Center for Environmental Research
Information
Cincinnati OH 45268
Postage and
Fees Paid
Environmental
Protection
Agency
EPA 335
Official Business
Penalty for Private Use $300
            PS    0000324
            U  S  t '•« V T K  P RUTf.C i' IU 4
    p      RfelGIGN   5  I.iaHA.iY
            230  S  OKABttUrti'j  SlKi^rCi'
                           Ib  60bU4
    L

-------