EPA-540/1-86-035
                                             Office of Emergency and
                                             Remedial Response
                                             Washington DC 20460
Off'ce of Research and Development
Office of Health and Environmental
Assessment
Environmental Criteria and
Assessment Office
Cincinnati OH 45268
                       Superfund
&EPA
                         HEALTH EFFECTS ASSESSMENT
                         FOR TRIVALENT  CHROMIUM

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                                           EPA/540/1-86-035
                                           September 1984
       HEALTH  EFFECTS  ASSESSMENT
         FOR  TRIVALENT CHROMIUM
    U.S. Environmental  Protection Agency
     Office of Research and  Development
Office of Health and Environmental Assessment
Environmental Criteria  and Assessment Office
            Cincinnati, OH  45268
    U.S. Environmental  Protection Agency
  Office of  Emergency and Remedial Response
Office of Solid Waste  and  Emergency Response
            Washington, DC  20460

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                                  DISCLAIMER

    This  report  has  been funded  wholly  or  In  part  by  the  United  States
Environmental  Protection  Agency under  Contract  No.  68-03-3112  to  Syracuse
Research Corporation.  It has been  subject  to  the Agency's  peer and adminis-
trative review, and  1t has been  approved  for  publication as an EPA document.
Mention of  trade  names or commercial  products  does not  constitute  endorse-
ment or recommendation for use.
                                      11

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                                    PREFACE


    This report  summarizes  and  evaluates Information relevant  to  a prelimi-
nary Interim assessment  of  adverse health effects associated  with trlvalent
chromium.   All   estimates   of  acceptable  Intakes and  carcinogenic  potency
presented 1n this  document  should  be  considered  as  preliminary and  reflect
limited  resources   allocated  to  this  project.    Pertinent  toxlcologlc  and
environmental data  were  located  through  on-Hne  literature searches  of  the
Chemical Abstracts, TOXLINE, CANCERLINE  and  the  CHEMFATE/OATALOG data bases.
The  basic  literature  searched  supporting  this   document  1s  current up  to
September,   1984.   Secondary  sources   of  Information have  also been  relied
upon  1n the  preparation of  this  report  and  represent  large-scale  health
assessment   efforts  that entail   extensive   peer  and  Agency  review.   The
following Office of  Health  and Environmental Assessment  (OHEA)  sources  have
been extensively utilized:


    U.S. EPA.    1980b.   Ambient  Water Quality  Criteria  for  Chromium.
    Environmental  Criteria  and  Assessment Office, Cincinnati,  OH.  EPA
    440/5-80-035.  NTIS PB 81-117467.

    U.S. EPA.   1983b.   Health  Assessment  Document  for  Chromium.   Pre-
    pared by the Environmental  Criteria  and  Assessment  Office, Research
    Triangle  Park,  NC.   External  review   draft.   EPA  600/8-83-014A.
    NITS PB 83-252205.


    The  Intent 1n  these  assessments Is to  suggest acceptable exposure levels
whenever sufficient data were  available.  Values were not  derived or larger
uncertainty  factors  were employed  when  the variable data  were  limited  In
scope  tending to generate conservative (I.e., protective)  estimates.   Never-
theless, the Interim values presented reflect the relative  degree of hazard
associated with exposure or  risk to the chemlcal(s) addressed.

    Whenever possible,  two  categories  of  values  have been  estimated for  sys-
temic  toxicants  (toxicants  for  which  cancer  1s  not the  endpolnt of concern).
The  first,  the  AIS  or acceptable  Intake  subchronlc, 1s  an estimate of  an
exposure  level   that would  not  be expected to  cause  adverse  effects  when
exposure occurs  during a limited  time Interval   (I.e.,  for  an Interval  that
does  not constitute a  significant  portion  of  the  Hfespan).    This  type  of
exposure estimate  has  not  been extensively  used  or rigorously defined,  as
previous  risk  assessment  efforts  have  been  primarily  directed  towards
exposures from  toxicants  1n ambient air or  water  where  lifetime exposure  1s
assumed.   Animal  data  used for  AIS  estimates  generally  Include exposures
with  durations  of  30-90 days.  Subchronlc  human data are  rarely  available.
Reported exposures  are usually  from chronic  occupational  exposure situations
or from  reports of acute accidental exposure.
                                      111

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    The AIC,  acceptable  Intake  chronic,   1s  similar 1n.concept  to the  ADI
(acceptable  dally  Intake).   It  1s  an estimate  of an  exposure  level  that
would  not  be expected  to cause  adverse effects  when  exposure occurs  for  a
significant portion  of  the Hfespan [see  U.S.  EPA  (1980a) for a  discussion
of  this  concept].   The  AIC  1s  route specific  and  estimates   acceptable
exposure  for  a given  route with  the   Implicit  assumption that exposure  by
other routes 1s Insignificant.

    Composite  scores  (CSs)  for  noncardnogens  have  also  been   calculated
where data  permitted.   These  values  are used for  ranking  reportable  quanti-
ties; the methodology for their development Is explained  1n U.S. EPA (1983a).

    For compounds for which there  1s sufficient  evidence  of  cardnogenlcHy,
AIS  and AIC values  are  not derived.   For a  discussion  of risk  assessment
methodology  for  carcinogens  refer to  U.S. EPA  (1980a).   Since cancer  1s  a
process that  1s  not  characterized by  a threshold, any exposure  contributes
an Increment of risk.   Consequently,  derivation of AIS and AIC values  would
be Inappropriate.  For  carcinogens,  q-|*s  have been computed  based on  oral
and Inhalation data If available.
                                      1v

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                                   ABSTRACT
    In  order  to  place  the  risk assessment  evaluation  1n  proper  context,
refer  to  the preface  of   this  document.  The  preface outlines  limitations
applicable to all documents of  this  series as  well  as the appropriate Inter-
pretation and use of the quantitative estimates presented.

    Data  are  limited   concerning   the   toxlcologlcal  effects  of  trlvalent
chromium salts.  Trlvalent chromium  appears to  have  a low order of toxldty,
presumably due to very  poor absorption,  especially following oral  exposure.

    Only  one subchronlc  study  adequate for  risk  assessment  was  located.
Cr203  was  administered 1n  the  diet of  rats  for 90 days at  levels of  2%
and 5%.  The  estimated  dally  consumption of Cr(+3)  Is  1373 mg/kg for the 5%
feeding  level.   Based  on  this,   an   AIS  of  979  mg/day  was  calculated.
Adequate subchronlc Inhalation data were not  located.

    Again, only  one chronic  feeding study was found, conducted  by  the  same
authors who  reported  the  subchronlc Investigation.   No adverse effects  were
seen  at  the  highest feeding  level,  5%.  The  daily  intake at  this  level  is
estimated as  1467 mg Cr(+3)/kg.   From  these  data,  an  AIC of  103 mg/day is
estimated.

    Chronic Inhalation data were not located.   An AIC of  0.357  mg Cr(+3)/day
is estimated based  on the  TLV.   All  of  these  estimates should be reviewed as
more complete data become available.

    Data were not sufficient for derivation of a CS.

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                               ACKNOWLEDGEMENTS


    The  Initial  draft  of  this  report  was  prepared  by  Syracuse  Research
Corporation under  Contract No.  68-03-3112  for  EPA's  Environmental  Criteria
and  Assessment  Office,  Cincinnati,  OH.   Dr.  Christopher  DeRosa and  Karen
Blackburn were the Technical Project Monitors  and  Helen Ball  wasvthe Project
Officer.  The final documents  In  this  series  were  prepared for the Office of
Emergency and Remedial Response, Washington, DC.

    Scientists from  the  following U.S. EPA offices  provided  review  comments
for this document series:

         Environmental Criteria and Assessment Office, Cincinnati, OH
         Carcinogen Assessment Group
         Office of A1r Quality Planning and Standards
         Office of Solid Waste
         Office of Toxic Substances
         Office of Drinking Water

Editorial review for the document series was provided by:

    Judith Olsen and Erma Durden
    Environmental Criteria and Assessment Office
    Cincinnati, OH

Technical support services for the document series was provided by:

    Bette Zwayer, Pat Daunt, Karen Mann and Jacky Bohanon
    Environmental Criteria and Assessment Office
    Cincinnati, OH
                                      v1

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                              TABLE  OF  CONTENTS

                                                                       Page

1.  ENVIRONMENTAL CHEMISTRY AND FATE	    1

2.  ABSORPTION FACTORS IN HUMANS AND EXPERIMENTAL ANIMALS 	    4

    2.1.   ORAL	    4
    2.2.   INHALATION	    4

3.  TOXICITY IN HUMANS AND EXPERIMENTAL ANIMALS 	    5

    3.1.   SUBCHRONIC	    5

           3.1.1.   Oral	    5
           3.1.2.   Inhalation	    5
    3.2.    CHRONIC.
           3.2.1.   Oral	    7
           3.2.2.   Inhalation	    7

    3.3.    TERATOGENICITY AND OTHER REPRODUCTIVE EFFECTS	    8



4.








5.


3.4.
3.3.1. Oral 	
3.3.2. Inhalation 	
TOXICANT INTERACTIONS 	 ,
CARCINOGENICITY- 	 ,
4.1.


4.2.


4.3.
4.4.
HUMAN DATA 	 ,
4.1.1. Oral 	 ,
4.1.2. Inhalation 	 ,
BIOASSAYS 	 ,
4.2.1. Oral 	
4.2.2. Inhalation 	 ,
OTHER RELEVANT DATA 	
WEIGHT OF EVIDENCE 	
REGULATORY STANDARDS AND CRITERIA 	
	 8
	 8
	 8
	 9
	 9
	 9
	 9
	 9
	 9
	 9
	 10
	 10
	 11
                                     V11

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                          TABLE OF CONTENTS  (cont.)

RISK
6.1.


6.2.



6.3.



ASSESSMENT 	
ACCEPTABLE INTAKE SUBCHRONIC (AIS) 	
6.1.1. Oral 	
6.1.2. Inhalation 	
ACCEPTABLE INTAKE CHRONIC (AIC) 	
6.2.1. Oral 	
6.2.2. Inhalation 	
6.2.3. Composite Score 	
CARCINOGENIC POTENCY (q-|*) 	
6.3.1. Oral 	 ,
6.3.2. Inhalation 	 ,
REFERENCES 	 ,
Page
12
	 12
...... 12
	 12
	 12
	 12
	 13
	 13
	 14
	 14
	 14
	 15
APPENDIX:  Summary Table for TMvalent  Chromium ............   21

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                             LIST  OF  ABBREVIATIONS





ADI                     Acceptable dally Intake



AIC                     Acceptable Intake chronic



AIS                     Acceptable Intake subchronlc



BCF                     B1oconcentrat1on factor



bw                      Body weight



CAS                     Chemical Abstract Service



CS                      Composite score



NOAEL                   No-observed-adverse-effect  level



NOEL                    No-observed-effect level



TLV                     Threshold limit value



TWA                     Time-weighted average
                                      1x

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                     1.  ENVIRONMENTAL CHEMISTRY AND FATE
    Chromium  1s  a  metallic  element  belonging  to  the First  Transitional
Series of  the  periodic table.  Elemental chromium  has  a CAS Registry number
of  7440-47-3.   The  three most  stable  forms In which chromium  occurs  1n the
environment are  0 (metal and alloys),  +3  and +6 valence states.   In  the +3
valence  state,  the  chemistry of  chromium  1s  dominated by  the  formation of
stable hexa-coordlnated  complexes  with  both  organic  and  Inorganic  Ugands
(Hartford,  1979).   In  the +6 valence  state, chromium  exists as  oxo species
such   as   CrO-   and   CrO.21- that  are   strongly   oxidizing   (Cotton   and
Wilkinson, 1980).
    Chromium 1n  the ambient  air occurs from  natural  sources,  Industrial and
product  uses,  and  burning of  fossil   fuels  and wood.   The most  Important
Industrial  sources  of  chromium  In  the atmosphere originate from ferrochrome
production.   Ore   refining,  chemical   and  refractory  processing,  cement
producing  plants, automobile  brake  lining  and  catalytic converters  for  auto-
mobiles  also  contribute  to  the atmospheric  burden for  chromium  (Flshbela,
1981).  Chromate chemicals used as  mist  Inhibitors  1n  cooling  towers and the
mist formed during chrome plating are  probably  the  primary  sources  of Cr(+6)
emitted as mists In  the atmosphere  (Towlll  et a!.,  1978).
    Scarce  Information exists 1n  the literature regarding  the  nature of the
chemical  species present  1n the atmosphere.   Under  normal  conditions,  Cr(+3)
and Cr(0)  In  the air  should not undergo any  reaction  (Towlll et  al.,  1978).
Cr(+6) 1n  air could eventually  react with  dust  particles or other  pollutants
to  form  Cr(+3)   (NAS,   1974);  however,  the  exact  nature of  such  atmospheric
reactions  has not been studied  extensively.   Chromium  Is removed  from air by
atmospheric  fallout and  precipitation  (Flshbeln,   1981).   The  atmospheric
half-life  for  the physical removal  mechanism 1s expected  to  depend on the
                                      -1-

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particle  size  and  particle  density  of  atmospheric  chromium.   Chromium
particles  of  small  aerodynamic diameter  (<10 ym) may  remain airborne  for
long periods of time and may  be transported  great distances by wind currents
and diffusion forces.
    Surface runoff, deposition  from air,  and  release  of  municipal and Indus-
trial wastewaters  are  the  sources of  chromium In  surface  waters.   The most
significant removal  mechanism  for Cr(+3)  from the aquatic  environment will
be   precipitation   as    Cr  0  «xH 0    and   eventually    sedimentation   of
                             C. O   £
Cr~0~«xH_0.   Cr(+6),  however,   may   exist  In  aquatic   media  as  a  water
  L. O   C.
soluble complex anlon and  may persist  1n  water for a  long time.  Cr(+6) Is a
moderately  strong  oxidizing  agent and  will  react with  organic matter  or
other reducing  agents  to  form  Cr(+3).   Eventually, Cr(+3) will  be  precipi-
tated   as   Cr203«xH?0.     Therefore,    1n   surface  water   rich   1n   organic
content, Cr(+6) will exhibit a much shorter lifetime (Callahan et  a!., 1979).
    Chromium   probably   occurs   as   the  Insoluble   Cr00«»xH00    In   soil,
                                                         CO   L.
given that  organic matter  1n soil  1s expected to  convert  any soluble chro-
mate  to  Insoluble Cr-0-  (U.S. EPA,  1983b).  There  1s  no  known  chemical
process that can cause chromium to be lost from soil.   The primary processes
by which  chromium  Is  lost  from  soil   are  physical.  For  example,  chromium In
soil can  be  transported  to the  atmosphere by  way of  aerosol  formation (U.S.
EPA, 1983b).  Chromium 1s  also  transported from soil  through runoff.  Runoff
can remove  both chromium  Ions  and bulk precipitates   of  chromium.   In addi-
tion, flooding  of  soils  and  the subsequent anaerobic  decomposition  of plant
matter  may  Increase  dissolution  of  Cr_0_   1n   soil  through  complexatlon
                                          c O
(U.S.  EPA,  1983b).   The  water  soluble  complexes may  cause   leaching  of
chromium  from  soil.   Page  (1981)  reported the detection of  a small concen-
tration  (1  yg/8.  mean  concentration)  of  chromium at a  frequency  of  -100%
1n groundwater collected from New Jersey.

                                      -2-

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    The BCF for  Cr(+6)  in  fish muscle appears to be <1.0, but  values  of  125
and 192  were  obtained  for  oyster and  blue  mussel,  respectively  (U.S.  EPA,
1980b).  For  Cr(+3),  BCF values  of  116,  153 and 86  were obtained with  the
American oyster, soft shell  clam and  blue  mussel  (U.S.  EPA,  1983b).
                                     -3-

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           2.  ABSORPTION  FACTORS  IN HUMANS AND EXPERIMENTAL ANIMALS
2.1.   ORAL
    Donaldson   and   Barreras    (1966)    administered    51CrCl3   (chromium
chloride)  orally  to  human  patients.   Based  on  fecal   excretion  of  51Cr,
absorption  was  -0.4%.    When   51CrCl3   was   administered  Intraduodenally,
absorption was not appreciably changed.
    In a  number  of  animal studies, gastrointestinal absorption  of  trlvalent
chromium  (as  CrCl»)  was estimated  to  be  <3%  (Mertz et  al.,  1965; V1sek  et
                  o
al., 1953; MacKenzle  et  al.,  1959; Ogawa, 1976).   Furthermore,  Mertz  et al.
(1965) reported that  absorption  In rats  was Independent  of the  administered
dose and dietary history (deficient or  supplemented 1n  chromium).
2.2.   INHALATION
    Trlvalent chromium  1s absorbed  very  slowly  by Inhalation.   Baetjer  et
al.   (1959a)  administered  CrCK  to  guinea   pigs   Intratracheally.    Ten
minutes post-treatment, 69%  of  the administered dose remained In  the  lungs,
while  4%  was found  1n  the blood  and  tissues.  Percentages  of  administered
chromium  found  1n the  lungs  24  hours,  30 days  and  60  days  post-treatment
were  45,  30  and  12%,  respectively.   These Investigators hypothesized  that
the slow  absorption of  trlvalent  chromium (which  1s water soluble)  1s  due to
the  fact  that  1t  forms  Insoluble  complexes  with  macromolecules.   Further-
more,  gastrointestinal  absorption  following  clearance  from  the respiratory
tract  may be a  factor  when  chromium  compounds  are administered by  Inhala-
tion.   V1sek   et  al.   (1953)   found   similar  results   when   5aCrCl3   was
Instilled  Intratracheally  1n guinea  pigs.  In  this  study,   absorption  from
the lungs  was  estimated to be -5%.  There  was  also evidence  of  gastrointes-
tinal  absorption  because  55 and  7%  of  the  administered  51Cr  had  been
recovered from the feces and urine, respectively, within 7 days.
                                      -4-

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                3.   TOXICITY  IN  HUMANS  AND  EXPERIMENTAL  ANIMALS
3.1.   SUBCHRONIC
3.1.1.   Oral.   Subchronlc  studies  regarding  oral  exposure  to  trlvalent
chromium are  summarized 1n  Table  3-1.  The  study by  Akatsuka  and Falrhall
(1934) cannot  be used  for quantitative risk  assessment since  the  dose  and
duration of exposure  were  not defined precisely.   The  study  by MacKenzle et
al.  (1958)  suggests a  NOEL  at  25  ppm CrCl_,  equivalent  to 8.2  ppm trlva-
                                            J
lent  chromium.   Assuming  that  an average  rat weighs  0.35  kg  and consumes
0.035 8.  water/day,  8.2  ppm  1s  adjusted  to  0.82  mg  trlvalent  chromium/kg
bw/day.
    The  study  by  Ivankovlc  and Preussman  (1975)  suggests  a  NOAEL of  5%
Cr-0.  (50,000  ppm) based  on  depression  of  spleen  and liver  weights.   The
  c. O
authors calculated, based  on  measured  food  consumption  and  body weight,  that
male  rats  1n  the  5%  feeding group consumed  180  g/kg of  Cr^O,,  total  over
the  88-day  experimental  period  (discerned  from  body  weight  graph).   This
corresponds to 1399 mg/kg/day of Cr(+3).
3.1.2.   Inhalation.   Only one  subchronic  animal  study regarding  exposure
to trlvalent chromium  by inhalation was  located 1n the  available literature.
Akatsuka and  Falrhall  (1934)  exposed  two cats  to  chromium  carbonate dust at
a  level   that  varied  from  3.3-83  mg/m3  (average  =   58.3  mg/m3)  for  86
sessions.  Each  session  varied  from 10-60 minutes,  averaging  28 minutes  for
one  cat  and  57  minutes for  the other.   No  effects   1n terms  of  gross  or
microscopic  pathology  were  observed  upon  termination of  the  experiment.
Examination of control animals, 1f there were any, was not  reported.
    No  human  data  that could  be used  in  quantitative risk  assessment  of
inhalation  exposure  to  trlvalent  chromium  were   located  in   the  available
literature.
                                      -5-

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                   TABLE  3-1



Subchronlc Oral Toxlclty of Trlvalent Chromium
Species
Rat
Rat
Cat
Number
12 males, 9 females
b males, b females/
control; 14 males,
5 females/2%; 5 males,
10 females/5%
10
Compound Vehicle Dose
CrCl3 drinking 0, 25 ppm
water
Cr203 bread 0, 2, 5%
chromium feed 50-100
carbonate, mg/cat/day
chromium
phosphate
i
Duration Effects
12 months No change In body weight.
No changes In macroscopic
or microscopic pathology,
or clinical chemistry
variables.
5 days/week No effect on body weight,
for 90 days urologlcal or hematologl-
cal variables, or food
Intake. Slight reduction
In spleen and liver weights
at 2 and 5% levels.
1-3 months No effect on weights or
gross or microscopic
pathology of major organs.
Reference
HacKenzle
et al., 1958
Ivankovlc and
Preussman, 1915
Akatsuka and
Falrhall. 1934

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3.2.   CHRONIC



3.2.1.   Oral.  Only one  chronic  study regarding oral  exposure  to tMvalent



chromium was  located.  Ivankovlc and  Preussman  (1975)  fed  60 male and female



rats  (per  dose group) 0,  1, 2 or  5% Cr 0   baked  1n bread on  5 days/week
                                         c O


for 600 feeding  days  (120 weeks).   The authors  estimated,  based  on measures



of  food  consumption and  body weight,  that  rats consumed  360  g/kg  bw,  720



g/kg  bw  and  1800  g/kg bw  of  total  Cr 0   over  the  duration  of  the  study



1n  the  1,  2  and 5%  Cr_0_  feeding groups,  respectively.   The highest  dose
                       £  O


level  (5%),   which  represented  a  total  Cr_0-  consumption  for  600  days  of



feeding of  1800  g/kg  bw,  corresponds   to a total  Cr  (+3)  Intake  of 1232  g/kg



or 1467 mg/kg/day, expanding  exposure  over 840  days  (600  days at  5 days/week



=  120  weeks  or  840  days).    Adverse  effects were not noted at  any  feeding



level.



3.2.2.   Inhalation.   Exposure  to   vapors  of   chromium   salts   have   been



suspected  as  a  cause of  asthma   In  occupatlonally-exposed  workers.   Until



recently,   chromium  specific  1mmunoglobul1n  E antibodies  had not  been  found



In affected workers  to confirm the  connection  between chromium  and  asthma.



Recently,   however,  Novey et  al.   (1983)  Identified  chromium specific  anti-



bodies  In  a  32-year-old  white male worker who experienced  a  productive



cough, wheezing  and  dyspnea within 2 weeks  of  beginning a  new job electro-



plating with  chromium.   Laboratory testing  of  this  Individual was performed



with placebo,  nickel  and  chromium solutions vaporized by heat.   The nickel



and  chromium  solutions precipitated  asthmatic   symptoms  Identical to  those



experienced on the  job.   The authors   concluded  that  the  affected Individual



developed an acquired sensitivity  to chromium and nickel vapors.



    Pertinent   data  regarding  chronic  exposure  of  animals  to  tMvalent



chromium by Inhalation could not be located  In the available literature.
                                      -7-

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3.3.   TERATOGENICITY AND OTHER REPRODUCTIVE  EFFECTS
3.3.1.   Oral.    Pertinent  data  regarding  the  teratogenldty  of   orally
administered  trlvalent   chromium could  not  be  located  1n  the  available
literature.
3.3.2.   Inhalation.    Pertinent   data  regarding   the  teratogenldty   of
Inhaled trlvalent chromium could not be located  1n the available literature.
3.4.   TOXICANT INTERACTIONS
    Pertinent  data   regarding  toxicant  Interactions   of  trlvalent  chromium
with other compounds  could not be located 1n  the available literature.
                                      -8-

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                             4.  CARCINOGENICITY
4.1.   HUMAN DATA
4.1.1.   Oral.    Pertinent  data  regarding  the  cardnogenlcHy  of   orally
administered  tMvalent   chromium  could  not  be  located  1n  the  available
literature.
4.1.2.   Inhalation.  Occupational exposure to  trlvalent  chromium and other
chromium compounds  by  Inhalation has been  studied  1n the chromate manufac-
turing  and  ferrochromlum  Industries;  however,  exposures  all  Include mixed
exposures  to  both  Cr(+3)  and   Cr(+6).   The  Cr(*6)  species  1s  the  Hkely
etlologlcal agent   In  reports  of  excess  cancer  risk  In  chromium workers.
Data addressing exposures to Cr(+3) alone are  not  available.
4.2.   BIOASSAYS
4.2.1.   Oral.    The results  of  several  studies  Indicate  that   trlvalent
chromium 1s not carcinogenic 1n  mice or  rats.
    Schroeder  et  al. (1965)  exposed 54  male  and  54 female  Swiss mice  to
drinking water that contained 5  ppm  chromium  (as  chromium  acetate)  for life.
No  Increase In  the  Incidence  of tumors was seen  1n  the  treated  animals  with
respect  to  controls.   Similar   results  were  obtained  by Schroeder  et   al.
(1965) for Long-Evans rats.
    Ivankovlc  and Preussman (1975) fed chromium trloxlde 1n  bread  to  60  male
and  female  rats  at levels  of   1,  2 or  5%,  5  days/week  for  2 years.    No
difference was  seen between  controls and  treated  animals  with respect  to
tumor Incidence.
4.2.2.   Inhalation.    Several   animal   studies   Indicate  that   trlvalent
chromium  compounds  are  not carcinogenic  when administered  by  Inhalation,
either  by  natural  routes  (Baetjer  et  al.,  1959a),  Intrapleural  Injection
(Baetjer et al.,  1959b;  Hueper  and Payne,  1962)  or  1ntrabronch1al  Implanta-
tion (Levy and Venitt,  1975; Levy and Martin,  1983).

                                      -9-

-------
4.3.   OTHER RELEVANT DATA



    In  general,  trlvalent  chromium was  not mutagenlc  1n bacterial  assays



when tested with or  without a mammalian activation  system (Venitt  and Levy,



1974; PetrllH and  Deflora, 1977,  1978a,b).   In  one study,  trlvalent chro-



mium was mutagenlc  in  Bacillus  subtllis. but this activity was  low compared



with compounds of hexavalent chromium (Nakamuro et al.,  1978).



    There is conflicting  information with regard  to  the  ability  of  trlvalent



chromium to  interact with  DNA.   Compounds  of  trlvalent chromium were found



to  be  clastogenic  in  BALB/c  cells as  CrCl3 (Raffetto,  1977), CHO  cells  as



CrCl3,   Cr(N03)3,    KCr(S04)2    or    Cr(CH3COO)3   (Levis   and    Majone,



1979),  Don  Chinese  hamster cells  as  hydrated  CrCl3 (Ohno et  al.,  1982)  and



in  cultured  human  leukocytes  as  Cr(CH_COO)/,  (Nakamuro et  al.,  1978),  but
                                        •J    3


not   in  mouse   FM3A  cells  as   Cr2(S04)3  (Umeda  and  Nishimura,  1979),



cultured  human   leukocytes  as  CrCK  or Cr(NOJ,,  (Nakamuro   et  al.,  1978)
                                    0          O  >J  —


or  Don Chinese hamster cells as Cr_(SOJ, (Ohno et al.,  1982).
                                   L.   *r  -J


4.4.   WEIGHT OF EVIDENCE



     IARC (1980)  concluded  that  animal  data  are  inadequate  for the evaluation



of  the  carcinogenlcity of  Cr(+3)  compounds.  Furthermore,  although there 1s



sufficient  evidence  of respiratory carcinogenidty  associated with exposure



to  chromium,  the relative contributions of  Cr(+3), Cr(f6), metallic chromium



or  soluble versus insoluble chromium to  carcinogenicity cannot be elucidated.



     Applying  the criteria for evaluating the overall weight  of  evidence  for



carcinogenicity  to  man  proposed  by the  Carcinogen  Assessment Group  of  the



U.S.  EPA (Federal  Register, 1984),  trlvalent chromium  1s  most appropriately



designated a Group D - Not  Classified material.
                                     -10-

-------
                    5.   REGULATORY STANDARDS AND CRITERIA







    The ACGIH  (1983)   has  recommended  a TLV-TWA  of 0.5  mg/m3 for  occupa-



tional exposure to  tMvalent  chromium.   This  level was established  1n  order



to minimize toxic  effects and to protect against pulmonary  disease.



    The U.S.  EPA  (1982) has  established a criterion  of  59 mg/a. for  trlva-



lent chromium 1n water.  This  Is  derived  from  the  Interim  ADI  of 125 mg/man/



day (see Section 3.1.1.) (Ivankovlc  and Preussman,  1975).
                                     -11-

-------
                             6.  RISK ASSESSMENT
6.1.   ACCEPTABLE INTAKE SUBCHRONIC (AIS)
6.1.1.   Oral.   Based  on the  study  by   Ivankovlc  and  Preussman  (1975),  the
NOAEL of  1399 mg tMvalent chromium/kg  bw/day for depression  of  spleen  and
liver weights 1n rats  can be used  to  calculate an AIS.  Dividing 1399 mg/kg/
day  by  an  uncertainty  factor  of 100  (10 to account for the  range  of sensi-
tivities In  the  human  population, 10 for extrapolating from animal  data to
humans), an AIS  of 13.99 mg/kg/day 1s established for  Ingestlon of tMvalent
chromium.  Assuming an average human weighs  70 kg,  this  1s equivalent to  979
mg/man/day.
6.1.2.   Inhalation.    Only  one study (Akatsuka and  Falrhall,  1934)  regard-
Ing  the  effects  of subchronlc  Inhalation of  trlvalent chromium  was  located
1n  the  available  literature.    Only two cats  were  exposed,  however,  and
neither  the   doses  nor  the  durations  of exposure  were   precisely  defined;
therefore, these data cannot be used 1n  quantitative risk assessment.
6.2.   ACCEPTABLE INTAKE CHRONIC (AIC)
6.2.1.   Oral.   The  NOEL   of  5%  Cr00.  [1467 mg  Cr(+3)/kg   bw/day  calcu-
                                     £ 0
lated  from measured  food and  body weight factors]  derived  from the  chronic
study by  Ivankovlc and Preussman  (1975)  on rats can be used as the basis  for
the  calculation  of an  AIC.   Dividing  the NOEL of  1467 mg/kg/day by an uncer-
tainty  factor of 1000  (10  to  account  for the  range  of  sensitivities In  the
human  population;  100   for  extrapolating from  animal  studies  to  humans  and
because  effects  seen In  the subchronlc  study were not specifically addressed
In  the  chronic  study), an AIC  of  1.467  mg/kg  bw/day   is  established  for
trlvalent  chromium.  Assuming  an  average human body weight of 70 kg,  this Is
equivalent to 103 mg/man/day.
                                     -12-

-------
    This value  differs  from  the  ADI  of 125  mg/man/day derived by  the  U.S.


EPA  (1982)  from the  Ivankovlc  and Preussman  (1975)  study because  the  U.S.


EPA  (1980b)  did  not  convert  ppm  Cr203  to  ppm  trlvalent  chromium,  and


used  standard  reference  values  for  the  rat for  food  consumption  and  body



weight 1n Heu of figures reported In  Ivankovlc  and Preussman  (1975).



6.2.2.   Inhalation.  Since  quantitative  chronic exposure  studies  regarding



Inhalation  of  trlvalent  chromium were  not  located  1n  the  available litera-


ture,  an  AIC  may  be calculated  from  the  TLV   of  0.5  mg/m3  established  by



the  AC6IH  (1983).   Adjusting to  units  of  mg/man/day, 0.5  mg/m3 x  5/7  days/



week  x  the average  work  day  human  Inhalation  rate  (10 mVday)  =  3.57



mg/man/day.   Dividing  3.57  mg/man/day  by  an  uncertainty  factor  of 10  (to



account for  the range of  sensitivities 1n  the   human population),  an AIC  of



0.357 mg/man/day 1s established for chronic  Inhalation of trlvalent chromium.



6.2.3.   Composite Score.  U.S.  EPA (1983c) calculated CSs for  chromium and



compounds  using  data  from   two  Inhalation  and  two  oral  studies.   These



experiments  were  conducted  with  hexavalent forms   of  chromium.    U.S.  EPA



(1983c)  also  reviewed  the  study 1n  rats   1n  which  a  slight  reduction  1n



spleen  and  Hver   weights  was  observed  1n animals  fed  bread  containing



Cr.O-  for   90  days  (Ivankovlc  and Preussman,   1975).   Since   similar  signs
  L.  *3

did  not appear  1n  rats  treated  with  Cr^O-  containing bread  for 2  years



(Ivankovlc  and  Preussman,  1975),   the  toxlcologlcal   significance  of  the


apparent  effects on  liver  and  spleen  weights   In  the subchronlc  study  was


questionable and a  CS was not derived from  these data (U.S. EPA, 1983c).  No



other  studies  with  trlvalent  chromium were found  from which  a CS  could  be



calculated.   Therefore,   In   their  review  of   the  data  base  for  trlvalent



chromium, U.S.  EPA  (1983a) calculated no  CSs based  on studies  with trlvalent



chromium.
                                     -13-

-------
6.3.   CARCINOGENIC POTENCY (q.,*)
6.3.1.   Oral.  IARC  (1980)  has concluded  that animal  data are  Inadequate
for the evaluation of the  carclnogenlcHy of  Cr(+3)  compounds.   The  two oral
studies  located  1n  the  available  literature  (Schroeder   et   a!.,   1965;
Ivankovlc and Preussman,  1975)  reported negative results  for  rats and mice.
6.3.2.   Inhalation.   Data  are   Inadequate   for   the  evaluation  of   the
carclnogenlcHy  of  Cr(+3)  compounds.   Animal  studies  have  been  negative
(Baetjer et  al.,   1959a,b;  Hueper   and  Payne,  1962;  Levy  and Venltt,  1975;
Levy and Martin, 1983).
                                     -14-

-------
                                7.   REFERENCES







ACGIH  (American  Conference  of  Governmental  Industrial  Hyg1en1sts).   1983.



Threshold Limit  Values  for  Chemical  Substances and  Physical  Agents 1n  the



Workroom Environment  with  Intended Changes  for 1983-1984.  Cincinnati,  OH.



p. 15.







Akatsuka, K. and Falrhall.   1934.  The  toxicology of  chromium.   J.  Ind.  Hyg.



16: 1-24.  (Cited in U.S.  EPA, 19835)







Baetjer, A.M.,  C.  Damron  and V.  Budacz.   1959a.   The distribution and  re-



tention  of  chromium 1n men  and animals.   Arch.  Ind. Health.    20:  136-150.



(Cited 1n U.S.  EPA, 1983b)







Baetjer, A.M.,  J.F. Lowney,  H. Steffee  and V.  Budacz.   1959b.  Effect  of



chromium on  Incidence  of   lung  tumors  1n  mice and rats.  Arch.  Ind.  Health.



20: 124-135.  (Cited 1n U.S.  EPA,  1983b)







Callahan, M.A.,  M.W.  Sllmak, N.W.  Gabel, et al.   1979.   Water-related  en-



vironmental   fate  of  129  priority  pollutants.  Vol.  I.   Office  of  Water



Planning and Standards,  Office of  Water and  Waste  Management,  U.S.   EPA,



Washington,  DC.   EPA 440/4-79-029a.







Cotton,  F.A. and   G.   Wilkinson.   1980.   Advanced  Organic  Chemistry.    A



Comprehensive Text, 4th ed.  John  WHey and Sons,  Inc., NY.   p.  719-736.
                                     -15-

-------
Donaldson,  R.M.  and R.F.  Barreras.   1966.   Intestinal  absorption of  trace
quantities  of  chromium.   J.  Lab.  CUn.  Med.   68:  484-493.   (Cited  1n  U.S.
EPA, 1983b)

Federal Register.   1984.   Environmental  Protection Agency.   Proposed guide-
lines for  carcinogenic  risk assessment.   Federal Register 49:  46294-46299.

F1shbe1n,   L.   1981.  Sources, transport  and alterations of metal  compounds:
An   overview.    I.   Arsenic,   beryllium,  cadmium,  chromium,   and   nickel.
Environ. Health Perspect.   40: 43-64.

Hartford,   W.H.   1979.   Chromium compounds.  In: K1rk-0thmer  Encyclopedia  of
Chemical  Technology, 3rd  ed., Vol. 6, M.  Grayson  and 0.  Eckroth, Ed.   John
WHey and  Sons, Inc., NY.   p.  82-120.

Hueper, W.C. and  W.W.  Payne.   1962.   Experimental  studies In metal  cardno-
genesls —  Chromium,  nickel,  Iron,  arsenic.   Arch.   Environ.  Health.   5:
445-462.   (Cited 1n U.S.  EPA,  1983b)

IARC (International  Agency  for  Research  on Cancer).   1980.   IARC  Monographs
on  the Evaluation  of  the  Carcinogenic  Risk  of Chemicals  to  Humans:  Some
metals   and   metallic   compounds.   WHO,   IARC,  Lyon,   France.    Vol.  23,
p. 205-323.

Ivankovlc,  S.  and R.  Preussman.   1975.   Absence  of  toxic and  carcinogenic
effects after administrations of high doses of  chronic  oxide  pigment  1n  sub-
acute and   long term  feeding experiments  1n  rats.   Food  Cosmet.  Toxlcol.   13:
347-351.

                                     -16-

-------
 Levls,  A.6.  and  F.  Majone.   1979.   Cytotoxlc and  clastogenlc  effects  of
 soluble  chromium  compounds  on mammalian cell cultures.   Br.  J.  Cancer.   40:
 523-533.   (Cited  In U.S. EPA, 19835)

 Levy,  L.S. and  P.A.  Martin.   1983.   The  effects  of  a  range  of  chromium-
 containing materials on rat lung.  Dye Color Manufacturers Association.

 Levy,  L.S. and  S.  VenHt.   1975.   Carcinogenic and  mutagenlc  activity  of
 chromium-containing materials.   Br. J.  Cancer.   32:  254-255.   (Cited  1n  U.S.
 EPA, 1983b)

 MacKenzle,  R.D.,  R.U.  Byerrum,   C.F.  Decker,  C.A.  Hoppert and F.L.  Langham.
 1958.  Chronic  toxldty studies.  II. Hexavalent and  tMvalent  chromium ad-
 ministered  1n drinking water to rats.  Am.  Med.  Assoc.  Arch.  Ind.  Health.
 18: 232-234.  (CHed 1n U.S. EPA, 1983b)

 MacKenzle, R.D.,  R.A.  Anwar,  R.U.  Byerrum and  C.A.  Hoppert.   1959.   Absorp-
 tion and  distribution of  51Cr  1n the  albino rat.   Arch. Blochem.  Blophys.
 79: 200-205.  (Cited 1n U.S. EPA, 1983b)

 Mertz,  W., E.E. Rog1nsk1 and  R.C. Reba.   1965.   Biological activity and  fate
 of  trace  quantities  of  Intravenous   chromium   (III)  1n   the  rat.   Am.  J.
 Physlol.   209: 489-494.   (CHed  1n U.S. EPA,  1983b)

Nakamuro,  K.,  K.  Yoshlkawa,  Y.  Sayato  and  H.  Kurata.   1978.  Comparative
 studies  of  chromosomal  aberration  and mutagenldty of  tMvalent  and hexa-
valent  chromium.  Mutat. Res.  58:  175-181.   (CHed  1n  U.S. EPA,  1983b)
                                     -17-

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NAS  (National  Academy of Sciences).   1974.   Medical  and Biological  Effects
of  Environmental  Pollutants:  Chromium.   National Academy Press,  Washington,
DC.

Novey,  H.S.,  M.  Hablb and  I.D.  Wells.   1983.   Asthma  and  IgE  antibodies
Induced  by  chromium  and  nickel  salts.   J.  Allergy  CUn.  Immunol.  72(4):
407-412.

Ogawa,  E.   1976.   Experimental  study on absorption, distribution  and excre-
tion of trlvalent and hexavalent  chromes.   Jap.  J.  Pharmacol.  26:  92.

Ohno, H., F. Hanaoka  and M. Yanada.   1982.   IndudblHty  of sister-chromatld
exchanges by heavy-metal  Ions.   Mutat. Res.  104:  141-145.   (Cited 1n U.S.
EPA, 1983b)

Page, G.W.  1981.  Comparison of ground water and  surface water  for patterns
and levels of contaminants by toxic  substances.  Environ. Sc1. Technol.  15:
1475-1481.

PetMlH, F.L.  and  S.  OeFlora.   1977.  Toxldty and mutagenldty of hexava-
lent  chromium  on  Salmonella  typhlmuMum.   Appl.   Environ. Mlcroblol.   33:
805-809.  (Cited 1n U.S.  EPA,  1983b)

PetrHH, F. and  S.  DeFlora.   1978a.  Oxidation of Inactive trlvalent chro-
mium to the mutagenlc hexavalent form.  Mutat. Res.  58:  167-178.   (Cited 1n
U.S. EPA, 1983b)
                                     -18-

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Petrim, F.L. and S.  DeFlora.   1978b.   Metabolic  deactlvatlon  of  hexavalent
chromium mutagenlcHy.  Mutat. Res.   54: 139-147.   (Cited In U.S.  EPA,  19835)

                                                                         
-------
U.S. EPA.  1982.   Errata  for  Ambient Water Quality  Criteria  Documents,  Feb.
23,  1982 update.   Prepared  by  the  Environmental  Criteria  and  Assessment
Office,  Cincinnati, OH,  OHEA  for  the  Office  of Water  Regulations  and Stan-
dards,  Washington, DC.

U.S. EPA.  1983a.  Methodology  and  Guidelines  for  Reportable  Quantity Deter-
minations Based  on  Chronic Tox1c1ty  Data.   Prepared  by  the  Environmental
Criteria and Assessment Office, Cincinnati, OH,  OHEA for  the  Office of Solid
Waste and Emergency Response,  Washington, DC.

U.S. EPA.  1983b.  Health Assessment Document  for  Chromium.   Prepared by the
Environmental  Criteria  and Assessment  Office,  Research  Triangle  Park,  NC.
External review draft.   EPA 600/8-83-014A.  NITS PB 83-252205.

U.S. EPA.   1983c.  Reportable  Quantity  for Chromium  (and  compounds).   Pre-
pared  by the  Environmental Criteria  and Assessment  Office,  Cincinnati,  OH,
OHEA for the Office of  Solid Waste and Emergency Response, Washington, DC.

Venltt,  S. and L.S.  Levy.   1974.   Mutageniclty  of  chromates  In bacteria and
Us relevance  to  chromate carclnogenesls.   Nature.   250:  493-495.   (Cited In
U.S. EPA, 1983b)

V1sek,  W.J., I.B.  Whitney,  U.S.G. Kuhn,  III and C.L.  Comer.   1953.  Metabo-
lism of  CR-51  by animals as  Influenced  by chemical  state.   Proc.  Soc.  Exp.
B1ol. Med.  84: 610-615.  (Cited 1n U.S.  EPA,  1983b)
                                     -20-

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                                                 APPENDIX

                                    Summary Table for TMvalent Chromium
               Species
             Experimental
             Dose/Exposure
                             Effect
                                                      Acceptable Intake
                                                         (AIS or AIC)
                        Reference
Inhalation

  AIS

  AIC
     Oral


^      AIS
—J
I



       AIC
  Maximum
  composite
  score
human
rat
rat
TLV-TWA =0.5 mg/m3
                          5% Cr203 =  NOAEL
5%
                   =  NOEL
                                  none
                        slight  reduction
                        In liver  and
                        spleen  weights
                                                  none
                                                      ND
0.357 mg/man/day     ACGIH. 1983
979 mg/man/day



103 mg/man/day


ND
                                                                            Ivankovlc and
                                                                            Preussman, 1975
Ivankovlc and
Preussman, 1975

U.S. EPA, 1983a
ND = Not derived

-------