United States
             Environmental Protection
             Agency
            Environmental Criteria and
            Assessment Office
            Research Triangle Park NC 27711
EPA-600/8-83-014F
August 1984
Final Report
             Research and Development
vvEPA
Health Assessment
Document for
Chromium
  Final
  Report

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                                  EPA-600/8-83-014F
                                      August 1984
        *             i
Health  Assessment Document
           for Chromium

             Final  Report
     Environmental Criteria and Assessment Office
     Office of Health and Environmental Assessment
         Office of Research and Development
        U.S. Environmental Protection Agency
     Research Triangle Park, North Carolina 27711
    p-S. Environ-ronta! P
    ~ . • -i -v- -1 T  , .    ".   •-••--,.
    .,,  ,,".'-''  ' "'•'" I 'J*'u  I ' .

              ' ~ "-tit, ho on 16'fJ
              60604

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                                   DISCLAIMER
                                                                      *

     This  document  has  been  reviewed   in   accordance   with  United   States
Environmental Protection Agency policy  and  approved for publication.  Mention of
trade  names  or  commercial  products  does   not  constitute   endorsement  or
recommendation for use.
                                      ii

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                                    PREFACE


                                                                     *
     The Office of Health and Environmental Assessment has prepared this health

assessment to serve as a "source document" for EPA  use.   The health assessment

document was originally developed for use by the Office of Air Quality Planning

and  Standards to  support  decision-making  regarding possible  regulation  of

chromium as a hazardous air pollutant.  However,  the scope of this document has

since been expanded to address multimedia aspects.

     In the  development  of the assessment document,  the  scientific literature

has been  inventoried,  key  studies  have been evaluated and  summary/conclusions

have been prepared so  that  the  chemical's  toxicity  and related characteristics

are qualitatively  identified.   Observed  effect  levels and other  measures  of

dose-response relationships are discussed,  where appropriate, so that the nature

of  the adverse  health  responses  are  placed  in  perspective  with  observed

environmental levels.
                                      iii

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                     AUTHORS, CONTRIBUTORS, AND REVIEWERS

     The Office of Health  and  Environmental Assessment  (OHEA)  of U.S. EPA  is

responsible for the preparation of this health  assessment document.

     Dr.   Si  Duk  Lee,  as the  Project Coordinator  and  editor,  had  overall

responsibility for coordination  and  direction  of the document  preparation  and

production effort.  The  chapters addressing physical and  chemical  properties,

sampling and analysis, air quality and  toxicity data  were prepared  by Life  and

Environmental  Sciences,  Syracuse  Research  Corporation,   Syracuse,  NY.    The

principal authors of these chapters are listed  below.



        Dr. Dipak Basu
        Karen Blackburn
        Dr. Bruce Harris
        Dr. Michael W. Neal
        Frederick W.  Stoss

     The OHEA Carcinogen Assessment Group (CAG) was responsible for preparation

of the sections on carcinogenicity.  Participating members of the CAG are listed

below  (principal  authors of present  carcinogenicity materials  are designated

by *).


        Roy E. Albert, M.D. (Chairman)
        Elizabeth L. Anderson,  Ph.D.
        Larry D. Anderson, Ph.D.
        Steven Bayard, Ph.D.
        David L. Bayliss, M.S.
       *Chao W. Chen, Ph.D.
        Margaret M.L. Chu, Ph.D.
       •Herman J. Gibb, B.S., M.P.H.
        Bernard H. Haberman, D.V.M., M.S.
       •Charalingayya B. Hiremath, Ph.D.
        Robert E. McGaughy, Ph.D.
        Dharm V. Singh, D.V.M.,  Ph.D.
        Todd W. Thorslund, Sc.D.
                                       iv

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     The following individuals provided peer review of this document or earlier
drafts of this document:

     U.S. Environmental Protection Agency

     Joseph Padgett
     Office of Air Quality Planning and Standards
     U.S. EPA

     Karen Blanchard
     Office of Air Quality Planning and Standards
     U.S. EPA

     Mike Waters, Ph.D.
     Office of Health Research
     Health Effects Research Laboratory
     U.S. EPA

     Jerry F. Stara, D.V.M.
     Office of Health and Environmental Assessment
     Environmental Criteria and Assessment Office
     U.S. EPA

     Debdas Mukerjee, Ph.D.
     Office of Health and Environmental Assessment
     Environmental Criteria and Assessment Office
     U.S. EPA

     Lester D. Grant, Ph.D.
     Office of Health and Environmental Assessment
     Environmental Criteria and Assessment Office
     U.S. EPA

     K.S. Lavappa, Ph.D.
     Office of Health and Environmental Assessment
     Reproductive Effects Assessment Group
     U.S. EPA

     External Peer Reviewers

     Dr. Ann Baetjer
     John Hopkins School of Hygiene
     615 North Wolfe Street
     Baltimore,  MD  21218

     Dr. Derek Hodgson
     Professor,  Chemistry Department
     University  of North Carolina
     Chapel Hill,  NC  27514

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     Dr.  Marshall Johnson
     Thomas Jefferson Medical College
     Anatomy Department
     1020 Locust Street
     Philadelphia, PA  19107

     Dr.  Magnus Piscator
     University of Pittsburgh
     Graduate School of Public Health
     Environmental Epidemiology
     Pittsburgh, PA  15261

     Dr.  Bruce Stuart
     Stauffer Chemical Company
     Farmington Avenue
     Farmington, CT  06032

     Dr.  Robert Tardiff
     1423 Trapline Court
     Vienna, VA  22180

     Dr.  Norman M. Trieff
     University of Texas Medical Branch
     Department of Pathology, UTMB
     Galveston, TX  77550

     Dr.  Jim Withey
     Health Protection Branch
     Dept. National Health and Welfare
     Tunney's Pasture
     Ottawa, Ontario
     CANADA K1A 012

EPA Science Advisory Board

     The  substance of  this  document  was independently peer reviewed  in  public
sessions  of the Environmental Health  Committee of EPA's Science Advisory  Board.
                                      vi

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                               TABLE OF CONTENTS

                                                                           Page

DISCLAIMER 	    ii

PREFACE 	   iii

AUTHORS, CONTRIBUTORS, AND REVIEWERS 	    iv

TABLE OF CONTENTS 	   vii

LIST OF TABLES 	    xi

LIST OF FIGURES 	   xiv

1.   INTRODUCTION 	   1-1

2.   SUMMARY AND CONCLUSIONS 	   2-1

     2.1  INTRODUCTION	   2-1
     2.2  FORMS, SOURCES AND CONCENTRATIONS OF CHROMIUM	   2-2
     2.3  MEASUREMENT METHODS	   2-1
     2.14  PHARMACOKINETICS AND ESSENTIALITY	   2-5

        2.U.1   Absorption, Transport and Excretion	   2-5
        2.1.2   Essentiality of Chromium	   2-7

     2.5  EFFECTS OF CHROMIUM ON BIOLOGICAL SYSTEMS AND HEALTH	   2-7

        2.5.1   Toxic Effects in Man and Animals	   2-7
        2.5.2   Genotoxicity, Carcinogenicity and Assessment of Risk	   2-9

3.   BACKGROUND INFORMATION 	   3-1

     3.1  CHEMICAL AND PHYSICAL PROPERTIES 	   3-1
     3.2  PRODUCTION, USE, AND RELEASES TO THE ENVIRONMENT 	   3-6

        3.2.1   Production of Chromium Compounds 	   3-6
        3.2.2   Uses of Chromium and Its Compounds 	   3-8
        3.2.3   Releases to the Environment 	  3-13

     3.3  ENVIRONMENTAL FATE AND TRANSPORT 	  3-17

        3.3.1   Air 	  3-17
        3.3.2   Water and Sediments 	  3-18
        3.3.3   Soil 	  3-20
                                      vii

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                           TABLE OF CONTENTS (cont.)
     3.4  LEVELS OF CHROMIUM IN VARIOUS MEDIA 	  3-20

        3.4.1    Ambient Air 	  3-20
        3.4.2    Aquatic Media 	  3-21
        3.4.3    Aquatic Suspended Materials and Suspended 	  3-28
        3.4.4    Soil 	  3-30
        3.4.5    Food 	  3-30
        3.4.6    Cigarettes 	  3-35

     3.5  INDICES OF EXPOSURE 	  3-36

        3.5.1    Chromium in Blood 	  3-36
        3.5.2    Chromium in Urine 	  3-38
        3.5.3    Chromium in Human Hair 	  3-40

     3.6  SUMMARY 	  3-41

4.   SAMPLING  AND ANALYSIS 	   4-1

     4.1  SAMPLING AND STORAGE 	   4-1

        4.1.1    Air 	   4-1
        4.1.2    Water 	   4-3
        4.1.3    Soil and Sediments 	   4-4
        4.1.4    Food 	   4-5
        4.1.5    Biological Samples 	   4-5

     4.2  SAMPLE PRETREATMENT 	   4-5

        4.2.1    Wet and Dry Ashing 	   4-6
        4.2.2    Precipitation 	   4-6
        4.2.3    Solvent Extraction 	   4-8
        4.2.4    Chromatographic Method 	   4-8

     4.3  METHODS OF ANALYSIS 	   4-9

        4.3.1    Atomic Absorption Spectrometry (flame) 	  4-13
        4.3.2    Atomic Absorption Spectrometry (flameless) 	  4-14
        4.3*3    Emission Spectroscopy 	  4-16
        4.3.4    Neutron Activation Analysis 	  4-16
        4.3.5    X-ray Fluorescence 	  4-17
        4.3.6   Colorimetric 	  4-18
        4.3.7    Gas Chromatography 	  4-19
        4.3.8   Chemiluminescence	  4-19
        4.3.9    Polarography 	  4-20
                                      viii

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                           TABLE OF CONTENTS (cont.)
        4.3.10  Mass Spectrometry 	  4-20
        4.3.11  Catalytic Method 	  l»-21
        4.3.12  Liquid Chromatography 	  4-21
        4.3.13. Particle Induced X-ray Emission	  4-21

     4.4  CONSIDERATIONS IN ANALYSIS 	  4-22

5.   CHROMIUM METABOLISM IN MAN AND ANIMALS 	   5-1

     5.1  ROUTES OF CHROMIUM ABSORPTION 	   5-1

        5.1.1   Chromium Absorption and Deposition by Inhalation 	   5-1
        5.1.2   Gastrointestinal Absorption of Chromium 	   5-4
        5.1.3   Chromium Absorption Through the Skin 	   5-6

     5.2  CHROMIUM TRANSPORT, METABOLISM, DISTRIBUTION,
          AND ELIMINATION 	   5-8

        5.2.1   Transport and Metabolism	'	   5-8
        5.2.2   Distribution 	  5-12
        5.2.3   Elimination 	  5-18

     5.3  SUMMARY 	  5-21

6.   CHROMIUM AS AN ESSENTIAL ELEMENT 	   6-1

     6.1  CHROMIUM DEFICIENCY 	   6-1
     6.2  GLUCOSE TOLERANCE FACTOR 	   6-4
     6.3  SUMMARY 	   6-6

7.   CHROMIUM TOXICOLOGY 	   7-1

     7.1  ACUTE EFFECTS OF CHROMIUM EXPOSURE IN MAN AND ANIMALS 	   7-1

        7.1.1   Human Studies 	   7-1
        7.1.2   Animal Studies 	   7-1
        7.1.3.  Chromium Hypersensitivity 	   7-4

     7.2  EVALUATION OF THE CARCINOGENICITY OF CHROMIUM 	  7-13

        7.2.1.  Animal Studies	  7-13
        7.2.2.  Epidemiologic Studies	  7.146
        7.2.3.  Quantitative Estimation	  7-79
        7.2.4.  Summary	 7-102
        7.2.5.  Conclusions	 7-106
                                      ix

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                           TABLE OF CONTENTS (cont.)

                                                                           Page

     7.3  GENOTOXICITY	 7_108

        7.3.1   In Vitro Mutagenicity 	 7-108
        7.3.2   Effects on DNA and DNA Replication 	 7-117
        7.3.3   Chromium Induced Chromosomal Aberrations and
                Cell Transformation 	 7-121

        7.3.1   Summary 	 7-128

     7.4  DEVELOPMENTAL TOXICITY AND OTHER REPRODUCTIVE EFFECTS 	 7-129

        7.1.1   Development Toxicity 	 7-129
        7.1.2   Other Reproductive Effects 	 7-136
        7.1.3   Summary 	 7-137
                      #
     7.5  OTHER TOXIC EFFECTS OF CHROMIUM 	 7-137

        7.5.1   Respiratory Effects 	 7-1U1
        7.5.2   Renal Effects of Chromium 	 7-155
        7.5.3   Miscellaneous Toxic Effects 	 7-156

     7.6  SUMMARY OF TOXIC EFFECTS OTHER THAN CANCER FOLLOWING
          EXPOSURE TO CHROMIUM COMPOUNDS 	 7-157

8.   CURRENT REGULATIONS AND STANDARDS 	   8-1

     8.1  OCCUPATIONAL EXPOSURE 	   8-1
     8.2  EXPOSURE TO CHROMIUM IN AMBIENT WATER 	   8-1
     8.3  EXPOSURE TO CHROMIUM IN AMBIENT AIR 	   8-5

9.   REFERENCES	   9>1

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                                LIST OF TABLES

Table                                                                      Page

3-1     Physical Properties of Selected Trivalent Chromium Compounds 	  3-3

3-2     Physical Properties of Selected Hexavalent Chromium Compounds ....  3-4

3-3     Manufacturers and Their Production Capacities of Sodium
        Chromate and Sodium Dichromate 	  3-9

3-1     Principal United States Manufacturers of Chromic Acid 	 3-10

3-5     United States Chromium Consumption Pattern in 1979 	 3-11

3-6     Sources and Estimates of United States Atmospheric Chromium
        Emissions in 1970 	 3-15

3-7     Regional Distribution of Principal Chromium Emissions 	 3-16

3-8     Five Forms of Chromium Transported in the Yukon and
        Amazon Rivers 	 3-19

3-9     Total Chromium Concentrations Measured in the Ambient Air of
        Selected Sites in the United States During 1977-1980 	 3-22

3-10    Chromium Levels in a Few Surface Waters and Groundwaters 	 3-26

3-11    Chromium Concentrations in U.S. Drinking Waters 	 3-27

3-12    Concentration of Chromium in Sediments 	 3-29

3-13    Chromium Content in Selected United States' Soils 	 3-31

3-14    Chromium Content in Various U.S. Foods 	 3-32

3-15    Concentration of Chromium in a Few Commerical Grade Acidic
        Foods 	 3-31

1-1     Composition and Efficiency of AA Extractant Solutions	  4-7

1-2     Analytical Methods for the Determination of Chromium	 4-10

6-1     Estimated Adequate and Safe Intake (EASI) for Chromium 	  6-2

7-1     Inhalation Exposure of Mice to Chromium-Containing Dust 	 7-14

7-2     Dosage Regimen for Intratracheal Instillation of Sodium
        Dichromate and Calcium Chromate	 7-19
                                      xi

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                                LIST OF TABLES

Table
7-3     Lung Tumor Incidence in Sprague-Dawley Rats Following
        Intratracheal Instillation of Sodium Dichromate or
        Calcium Chromate	 7-20

7-1     Combined Lung Tumor Incidence in Sprague-Dawley Rats
        Following Intratrachael Instillation of Sodium Dichromate and
        Calcium Dichromate	 7-21

7-5     Carcinomas Produced with Chromium Compounds in Rats	 7-22

7-6     Living Tumors Found and Microscopically Confirmed	 7-24

7-7     Incidence of Lung Tumors in Rats Following Intrabronchial
        Implantation of Various Chromium Compounds	 7-27

7-8     Exposure Schedule for Bioassay of Chromium Compounds By
        Intrapleural Injection	 7-29

7-9     Compounds Reported to Have Been Tested for Carcinogenicity by
        Intrapleural Implantation	 7-31

7-10    Experimental Conditions Used to Study the Effect of Intrafemoral,
        Intraperitoneal, and Intravenous Administration of Chromium	 7-34

7-11    Levels of Hexavalent Chromium in Fractionated Residue Dust	7-36

7-12    Compounds Reported to Have Been Tested for Carcinogenicity by
        Intramuscular Implantation	 7-37

7-13    Carcinogenicity of Chromium Compounds in Experimental Animals	7-11

7-14    Location of Chromate Manufacturing Plants Which Participated
        in Epidemiologic Studies and Plants from Which Vital Statistics
        Were Obtained for Each Study	 7-48

7-15    Observed Number of Deaths, Standardized Mortality Ratios (SMRs),
        and 95$ Confidence Limits (95$ CL) for Deaths Due to Cancer of
        the Trachea, Bronchus, and Lung and the Number of Reported Deaths
        for Which No Certificate Could Be Obtained, by Year of Initial
        Employment, Exposure Category, and Total Duration Employed, for
        Workers Initially Hired As Hourly Employees	 7-58

7-16    Lung Cancer in Workers in the Chromate Pigment Industry	7-69

7-17    Mortality Ratios Resulting from Malignant Tumors Among Workers
        in Chromium Ferroalloy Production	 7-74
                                      xii

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                             LIST OF TABLES (cont.)

Table

7-18    Age-Specific Lung Cancer Deaths and GradienttExposures to Total
        Chromium	  7-85

7-19    Combined Age-Specific Lung Cancer Death Rates and Total Chromium
        Exposure (in pg/nr)	    7.86

7-20    Comparison of Unit Risks (Lifetime Risk Due to  1 pg/m^ of
        Hexavalent Chromium in Air)	  7-97

7-21    Relative Carcinogenic Potencies Among 51 Chemicals Evaluated
        by the Carcinogen Assessment Group As Suspect Human Carcinogens..  7-99

7-22    The In Vitro Mutagenicity Bioassay of Chromic Compounds 	 7-109

7-23    Chromium Produced Clastogenic Effects and Cell Transformation  ... 7-122

7-24    Teratogenic and Fetotoxic Effects of Chromium 	 7-133

7-25    Studies Suggesting NOAELS or NOELS 	 7-139

7-26    Clinical Findings in Workers Employed in Chromium-Plating
        Plants 	 7-143

7-27    Perforation of Nasal Septum in Chromate Workers 	 7-146

7-28    Perforation of Nasal Septum in Chromate Workers 	 7-147

7-29    Nasal Medical Findings in a Chromium-Plating Plant 	 7-148

7-30    Medical Complaints of Workers in "hard" Chromium Electroplating
        Plant 	 7-154

8-1     Recommended Occupational Standards and Recommended Criteria for
        Chromium Compounds in the United States 	  8-2

8-2     Recommended Standards for Chromium in Ambient Waters in the
        United States 	  8-3

8-3     Ambient Water Quality Criteria for the Protection of
        Human Health 	  8-4

8-4     Calculated  Ambient Water Quality Criteria for the Protection
        of Aquatic  Life 	  8-6
                                     xiii

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                                LIST OF FIGURES
Figure
3-1
5-1
5-2
Simplified flow chart for the production of metallic chromium
and its compounds from chromite 	
Rate of blood clearance of intravenously injected ^1Cr(III)
from male rats 	
Whole-body elimination of intravenously administered ^Cr(III)
Page
3-7
5-13
5-19
7-1     Histogram representing the frequency distribution of the potency
        indices of 54 suspect carcinogens evaluated by the Carcinogen
        Assessment Group 	   7-98
                                      xiv

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                                1.  INTRODUCTION




     The 1970 Clean  Air  Act and its  1977  amendments mandate EPA  to regulate,




under Section 112,  those pollutants that "may reasonably be anticipated to result




in  an  increase  in  mortality  or  an  increase  in  serious  irreversible,  or




incapacitating reversible,  illness."   It  also  states that EPA  must regulate,




under Section 111  (d), those pollutants  that  "may  reasonably  be anticipated to




endanger public health or welfare."




     For this  reason, the  Office of Air  Quality  Planning and Standards has




requested that the  Office of Health and Environmental  Assessment prepare a scien-




tific assessment for chromium so that  it can be determined whether the regulation




would be warranted under these sections of the Clean Air Act,  since human expo-




sure to  chromium has been a matter of public health concern.   Therefore, this




chromium document will serve as  a  scientific  data  base for regulatory decision



making by the agency.  The health assessment document should represent an inter-




pretive summary of relevant  studies  rather than a compendium of all available




papers.



     The present document represents  a comprehensive  data  base  that considers




all sources of chromium in the  environment, the  likelihood  for  its exposure to




humans, and the possible  consequences  to man and lower organisms from its absorp-




tion.  This information is integrated into a format that can serve  as the basis



for qualitative and quantitative risk  assessments, while at  the same time identi-




fying gaps in our knowledge that limit accurate health assessment at this time.




Thus, it is expected that this  document may serve the information needs of other




government agencies  and  the private  sector that may  be  involved  in  decision




making and regulatory activities.
                                      1-1

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                          2.  SUMMARY AND CONCLUSIONS








2.1. INTRODUCTION








     Trivalent  Chromium  (Cr III) is considered  an essential micro-nutrient at




relatively low  levels, largely because chromium deficiency results in a buildup




of  glucose  in  the blood.   At much higher  levels, certain hexavalent chromium




(CrVI) compounds are  known to be carcinogens.  Thus, chromium  is unique among the




metallic  elements,   given   its  paradoxical  roles   in  both   nutrition  and




carcinogenesis.   The  seemingly  contradictory  information  on  the  effects  of




chromium is being clarified through increasing understanding of the role of the




differing oxidation  states  and  types  of chromium  compounds, which  apparently




determine the  relative risks and  benefits  to human health  of chromium  in its




various forms.




     In the ambient environment,  however, most of the monitoring information has




provided  only  total  elemental   chromium  levels.    Outside  of  occupational




settings, only  limited information exists on the types of chromium compounds to




which  the  public  is  exposed,   although  the trivalent  form  is  known  to  be




predominant.  The  assessment  which follows focuses on several key areas which




bear on  the kind  and extent of effects associated  with chromium  compounds:



sources and concentrations of important chromium  compounds  (particularly Cr(III)




and  Cr(VI));  measurement  methods;  pharmacokinetics  and  essentiality;   toxic




effects in man and animals;  and carcinogenic risks.








2.2. FORMS,  SOURCES AND CONCENTRATIONS OF CHROMIUM








     Chromium is  a metallic element which  occurs  in  nature primarily  as  the




mineral chrotnite; elemental  chromium does not occur naturally.  Chromium exists





                                      2-1

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in four oxidation states,  but only two of them, Cr(III) and Cr(VI), appear to be



important, owing to their  predominance and stability in the ambient environment.



All  forms are  influenced greatly  by  pH,  which  affects  the  solubility  and



subsequent reactivity of chromium ions.  Trivalent chromium is chemically basic,




while hexavalent chromium is acidic.



     Trivalent  chromium  is  the most  stable  oxidation  state,  and  the  most



important chemically.   Its  foremost characteristics are  its  ubiquitousness in



the  environment  as  part of  the   earth's  crust,  and  its  tendency to  form



kinetically inert hexacoordinate complexes.  It  reacts  with aqueous hydroxides



to form  insoluble  chromium  hydroxide.   Hexavalent chromium  is  the second most




stable  state,  but  the  most  important  toxicologically.   It  occurs  rarely in



nature, apart from man's intervention, because it is readily reduced to Cr(III)



in the presence of organic matter.   It is quite soluble,  existing in solution as



a complex anion.   However,  in certain  soils and natural  waters,  it can remain



unchanged for protracted periods of time.



     Chromite ore  is  not  mined in   the  United  States, but Cr(VI)  chemicals are



produced from imported ores, amounting to 21% of total U.S. chromium consumption.



Metallurgical processes constitute  approximately 6058, and refractory uses about



18J.  Little direct  information exists on the speciation of chromium compounds in



the environment, because of the limitations of existing measurement methods (as



described below).  Accordingly, knowledge of chromium chemistry and its sources



must be  relied  on  in  estimating  the relative  ambient contribution of different



species.   Direct  sources  include  chemical  and  refractory  plants;  indirect



sourc'es  include fossil fuel  combustion, waste  incineration and  cement  plant



emissions.



     Some source  categories  are likely  to  emit both trivalent and hexavalent



forms of chromium.   These are steel,  refractory, chemicals  manufacturing, as well
                                      2-2

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as sewage sludge and municipal  incineration.   Cooling towers and chrome plating


facilities emit  hexavalent  chromium,  and chromium ore refining, ferro-chromium


production, cement  production, and coal  and oil  combustion  are likely  to be


sources of trivalent chromium.  Maximum annual average ambient  (total) chromium


levels within 20 kilometers of these sources  range  from approximately 0.01-13.50
     Background ambient air concentrations of total chromium have ranged from as

                 O                               •}
low as 0.005 ng/nr (at the South Pole) to  1 . 1 ng/nr in other remote areas of the


world.  In the United States, recent monitoring of the ambient air in many urban


and non-urban  areas has  shown  total chromium concentrations averaging  in the


range  of  approximately  0.005-0.157  ng/nr.    The  maximum  24-hour  average


concentration found for any one site was 0.684 jig/m  in the Baltimore, MD area.


Because Cr(III) is highly stable and Cr(VI) reacts over  time to form Cr(III), it


is assumed  that most chromium  in ambient  air  occurs  in the  trivalent  state.


Monitoring of both  the  species and  oxidation states of chromium in the ambient


air should be a priority  for future research.


     The  chromium  concentration  in  U.S.  waters  varies  with  the  type  of


surrounding industrial sources and the  type of underlying soils.  An analysis of


approximately  1,000 tap  water samples  in  representative  U.S. cities  showed


chromium concentrations ranging from 0.4 to 8 ppb.  Chromium levels in soil vary


with soil origin and degree of contamination from anthropogenic sources.   Tests


on domestic soil have shown  chromium concentrations  ranging  from  an average of


14-70 ppm.  Because the amount of chromium in food  and food plants is relatively


low,  'and because  chromium does  not appear  to accumulate  in  mammalian systems,


bioaccumulation  in  the  soil-plant-animal  system  does  not  appear  to  be  a


significant exposure source.
                                      2-3

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2.3. MEASUREMENT METHODS








     One of  the main  problems  in assessing  the  effects of chromium  on human



health is  the  lack of  adequate methods  to  measure the  types and  amounts  of



chromium compounds. Prior to  1978, urinary chromium levels fell within the range



of 2 to 20  fig/fc.  In 1971, radio-tracer experiments indicated that approximately



0.5-1$ of the chromium was absorbed throught the digestive system.  Accordingly,



chromium excretion of  10  pg/day would  correlate  with a chromium  intake  of 1-2



mg/day.  However, few diets contain more than 100 (ig/day chromium; this anomaly



was  resolved  by showing  that  the  background collection  capabilities  of the



analytical methods used to measure chromium (atomic absorption) were inadequate



for chromium determinations.



     Several methods  are  available  for  measuring  elemental  chromium in  both



environmental  and  biological  samples.    These   include  atomic  absorption



spectroscopy, instrumental neutron activation  analysis, X-ray fluoroescence, and




particle-induced X-ray emissions  (PIXE).   While  these  methods  are sensitive to



the ppb level, problems in sample collection,  preparation and  interferences are



shared by all.  In biological samples,  neutron activation analysis data tend to



be lower than atomic  absorption and  X-ray fluorescence data.   In environmental



samples, neutron activation analysis data are higher. Generally, a comparison of



the  results  indicates  that modified atomic  absorption spectroscopy  provides



relatively reliable analyses.  Another problem in chromium determination is the



lack of adequate reference materials.  Ideally, reference materials should match



the samples to be  analyzed  with respect to chromium levels and  each reference



composition.  Because  the materials  are not  yet  standardized,  inter-laboratory




comparisons are difficult.



     Techniques  for   monitoring  hexavalent   chromium  are  also  subject  to



considerable error.  For  example, although the OSHA colorimetric method  is the

-------
most commonly used analytical tool,  particularly  in occupational settings,  low



sample recoveries have been reported in chromium levels of less than 10 |ig.








2.U. PHARMACOKINETICS AND ESSENTIALITY








2.U.1.    Absorption, Transport and Excretion.  An understanding of the role of



chromium  as  an  essential  nutrient  and  causative  agent  in  toxicity  and



carcinogenicity  requires  knowledge  of  the rates of  absorption,  mechanisms of



absorption, transport and organ distribution of the various chromium-containing



compounds.  There are three primary routes of entry for chromium into the human



body.  For most people,  the  gastro-intestinal  (GI) tract is the primary route of



uptake,  while  in  occupational  exposures  the  airways and  skin are  the most



important routes of uptake.  Rates of uptake in the GI tract depend on a number of



different factors, such as  the  valence   state of chromium in the compound, the



water  solubility of  the  compound  and the passage  of time  through the tract.




Uptake in the airways is also  influenced by the particle size distribution  of the



inhaled aerosols, and on  factors which govern the clearance time of the lung.



     Limited  work  on humans  has  been carried out  on the relationship between



exposure to trivalent chromium compounds and lung uptake and urinary  excretion of



chromium.   In one study  on workers  exposed  to chromium lignosulfonate, it was



demonstrated  that  while  chromium  in the  chromium  lignin  was  present  in  the



trivalent   state,  it  acted  pharmacokinetically   like  water   soluble  Cr(VI)



compounds.   An  average  of  14  pg/Jl  of urine  was excreted, at  an atmospheric



chromium  lignin concentration of 50  (jg  chromium/m .  One to two percent of the




inhaled chromium was excreted in the urine.



     For  Cr(VI),  the  urinary  chromium  concentrations  corresponding  to  an



airborne concentration of 50 iig/nr  Cr(VI) were UQ pg/fc in one study,  and 10 to 20
                                      2-5

-------
     in another. It was noted that chromium-bearing particles stay longer in the



airways in smokers than in non-smokers.




     The established normal levels of chromium in whole blood and in serum have



declined  with  time,  reflecting  the  changes  and  improvements in  analytical



methods.   In the  airways and  in the GI  tract,  soluble Cr(VI)  compounds are



apparently taken up by epithelial cells  by simple diffusion through the plasma



membrane.  After entry,  Cr(VI) reduction  occurs from the action of enzymatically



mobilized electrons,  which are available from GSH,  NADPH, and NADH.  The reducing



capacity  inside  the  cell   is  limited,   so  that  Cr(VI)  and  Cr(III)  exist



simultaneously  inside the cytoplasm;  Cr(VI)  is  then released from  the  cell by



simple diffusion into the blood stream and taken up into blood cells.  In spite



of the refined  methods of analysis available, a reliable  range  of normal blood



chromium concentrations  cannot be given with confidence.   When using  modern



methods for analysis, the whole blood concentration may be suggested to be within



the range of 0.5 to 3 ppb, while the serum level is probably below 0.2 ppb.




     The chromium concentration in human  tissues has been shown to decrease with



increasing age.  In contrast  to this,  chromium  concentrations  in the lung have



been shown to increase with age.   This increase in chromium content in the lungs



may  be  due  to deposition   and   retention  of  insoluble  chromium-containing



particles from the inhaled environmental  air,  as well  as from tobacco smoke.








2.4.2.    Essentiality of Chromium.   Animal  studies  have demonstrated  that



chromium-deficient rodents gain  less  weight  and have a shorter  life-span  than



animals maintained on  a  diet containing adequate  chromium values.   Chromium



deficiency results in glucose intolerance in  rats.  This  intolerance can  be



reduced with dietary treatment  with  Cr(III).   In humans, symptoms  of chromium



deficiency consist of glucose intolerance, weight  loss  and confusion.   Those
                                      2-6

-------
prone  to chromium deficiency  include  the elderly,  diabetics,  pregnant women,



malnourished children, offspring or siblings of diabetics and persons with early



coronary heart  disease.   Although the exact  level  of chromium needed for good


health   is  not  known,  the  average  American  intake  of  50  to  200  jig/day  is



considered  adequate  because at  such  levels symptoms  associated  with chromium



deficiency  are  not observed.  It  should  be noted that there is a considerable



difference  between the low levels of intake that are associated with nutritional



deficiency  and  the  high levels  of exposure  which are  associated  with toxic



effects.






2.5. EFFECTS OF CHROMIUM ON BIOLOGICAL SYSTEMS  AND  HEALTH






2.5.1.    Toxic Effects  in Man  and  Animals.    The  effects  of both Cr(III)  and



Cr(VI)  have been  studied in  man and animals.   Both  long-term  and  short-term


exposure conditions have been investigated, but most of the  long-term exposures



have focused on carcinogenic effects (discussed in  Section 2.5.2. below).



     The relative chemical inactivity of Cr(III) compared  with Cr(VI) correlates



with various acute toxicity studies on chromium salts.  Oral  LD_rt (dose lethal to
                                                              30


50$ of recipients) levels in rats have been reported to range from 135 mg/kg to



11,260 mg/kg for Cr(III).  As seen in the previous  section on pharmacokinetics,



the relatively high amounts  of'Cr(III)  which  are required to cause death arise



from the relative insolubility and poor  intestinal absorption of most Cr(III)



compounds.    Unlike  the  trivalent  compounds,  those of  Cr(VT)  tend  to  cross



biological   membranes  fairly  easily,  and  are  somewhat  more readily  absorbed



through  the gut or through  the  skin.   The  strong oxidizing powers  of Cr(VI)



compounds explain much of their irritating and toxic properties.



     Exposure to  Cr(VI)  has  been associated primarily with  renal  damage.   For



humans no quantitative evidence of acute toxcity through oral ingestion has been




                                      2-7

-------
reported.   In various  animal species,  single  injections  of  2 mg/kg  caused


cellular and structural damage in the kidneys.


     The effects of chromium  on  the skin were  recognized  over  150  years  ago.


Many chromium compounds can damage the skin,  but metallic  chromium or chromium


alloys  are  chemically inert  and are  not harmful.   The  effects of  chromium


compounds on  the skin are  caused primarily  by direct contact.   Most  of the


effects have occurred  in occupational settings, and,  as expected, with more men


than women reporting effects.   Cr(VI) derivatives can cause ulcers of the hands


and accompanying perforations  of the nasal septum.  Allergic contact dermatitis


may arise from  exposure to either  trivalent or hexavalent  chromium,  although


hexavalent chromium is responsible  for  most of the reported  cases.   Cr(VT)


penetrates undamaged  skin,  and subsequently  reduces to Cr(III)  which combines


with proteins or other skin components to form a whole skin allergin.


     Effects on  the upper respiratory tract  have been observed  in  workers in


chromium-related industries.   The  major effects  of chromium  on this  system


include ulceration  of  the  nasal septum, with subsequent perforation, and chronic


rhinitis and pharangitis.  Early  studies  indicated that approximately one-half


to four-fifths of the  workers  in chromate plants had  perforated nasal septa, at


levels  of exposure  that approached  1  mg/m .   Subsequent  work  indicated  that

                                      •2
chromic acid levels exceeding  0.1 mg/m   also  caused  perforated septums in some


workers.


     Limited work has  been reported on reproductive effects of chromium.  Cr(VI)


and Cr(ITI)  have been  found to cross the placental barrier in animals (hamsters


and mice) and  enter the fetus during mid to late gestation.   Fetal uptake of


Cr(VT), however, was much greater than that  of  Cr(III).   Developmental effects


attributed to both  Cr(VI)  and Cr(IIT) differed  between hamsters and mice, and


included such external abnormalities as  cleft  palate and  skeletal defects, and
                                      2-e

-------
 (in one  study of  a Cr(III)  compound) neural  tube defects.   One  researcher



 concluded that  Cr(VI)  occurred  at sufficiently  high  fetal concentrations  to



 cause direct effects on embryonic structures, but also questioned whether all  of



 the teratogenicity  and  fetal toxicity  associated with exposure  to Cr(ITT) might



 be attributed  to  extra-embryonic  effects,  for  example,  those  on  placental



 tissues.








 2.5.2.    Genotoxicity, Carcinogenicity and Assessment  of Risk.








      2.5.2.1.   GENOTOXICITY  — In recent years, much evidence has accumulated  to



 show  that  compounds  of chromium possess the ability to cause transformations and



 mutations, as  evaluated in a wide variety of in vitro assays such as  the  reverse



 and  forward  mutation,  gene  conversion,  and DNA  modification tests.    Genotoxic



 effects have been demonstrated primarily for chromium compounds containing the



 Cr(VI)  species, including effects such  as:




     — Mutagenic responses  in bacterial strains.



     — Morphologic  changes  in mammalian fetal cells.



     — Cytogenic effects on mammalian  bone marrow cells.



     — Increased gene conversion in yeast  species.



     — Increased transformation frequencies in mammalian cells.



     ~ Chromosomal damage in cultures  of human lymphocytes.



     In general,  soluble  Cr(VI) compounds  are  less active in  the presence of



metabolic  activating systems.   The  reduction of Cr(VI)  to  Cr(III) by cellular



agents  in metabolic activation systems, in part,  explains the reduced mutagenic



activity of  Cr(VI)  in the presence of such activating  systems.  Some  recent



evidence implicating both  Cr(VI)  and Cr(III)  in induced mutagenesis  has been



reported in  DNA interaction  and  DNA polymerase  infidelity  assays, and several



tests with apparently pure Cr(III) samples have found chromosomal aberrations.



                                      2-9

-------
     However,  with  the  exception  of  hexacoordinate Cr(ITI)  compounds,  and

Cr(III) compounds  contaminated with  Cr(VI), trivalent  chromium is  generally

considered to be a  relatively inactive genotoxic agent, owing to its inability to
                                                                      •»
cross cell membranes.




     2.5.2.2.  CHROMIUM  CARCINOGENESIS   AND  ASSESSMENT  OF  BISK   —     The

epidemiologic  studies of  chromate  production  workers  have  demonstrated  an

association of exposure to chromium compounds with respiratory cancer.  Whether

the association implicates hexavalent chromium  (Cr VI) alone,  or trivalent (Cr

III) as well,  is not  definitively  addressed  by  these studies.   The strength of

the association is evidenced by the high relative risks of lung cancer (e.g., a

lung cancer mortality ratio of 29 was found in one study  of chromate production

workers),  the  consistency  of results by  different  investigators in  different

countries, a dose-response relationship,  and  the  specificity of  the tumor site

(i.e., the  lung).   Results of three epidemiologic  studies of  chrome  pigment


workers also provide  suggestive evidence  that these  workers are  at  an elevated

risk of lung cancer.  One epidemiologic study of chrome pigment workers (Davies

1978, 1979)  suggested that zinc chromate was carcinogenic  while lead chromate was

not.  However,  the usefulness of the data on the lead chromate pigment workers is

limited by small sample size.   Using the criteria of the International Agency for

Research  on  Cancer (IARC), the  epidemiologic studies  of  chromate  production

workers would be classified as showing sufficient evidence of carcinogenicity.


     Several hexavalent chromium compounds have been shown to be carcinogenic in

cancer bioassay studies.   Only calcium  chromate has  consistently produced lung

tumors in rats by several routes of administration.   Other chromium compounds—

strontium  chromate,  zinc  chromate,  sodium  dichromate,  lead  chromate,  lead

chromate oxide, and sintered chromium trioxide—have  produced  local  sarcomas or
                                     2-10

-------
lung tumors in rats at  the site of intrabronchial, intratracheal, intramuscular,



subcutaneous  and  intraperitoneal application.   Hexavalent  chromium compounds



have not  induced  lung  tumors  by inhalation;  however,  studies  have not  been



reported in detail.  Trivalent chromium  compounds  have not been reported to be



carcinogenic  by  any route of administration.   Animal  cancer  bioassay  studies



suggest that  hexavalent  chromium compounds  (particularly soluble and sparingly



soluble compounds)  are  probably  the etiologic agent in chromium related human



cancer.  Under the TABC  criteria, the  animal bioassay  studies would constitute



sufficient evidence of the carcinogenicity of hexavalent chromium compounds.



     Using the IARC classification  scheme,  the level  of carcinogenic evidence



available for the combined animal and human data would place hexavalent chromium



(Cr VI) compounds into Group 1,  meaning that there is decisive evidence for the



human carcinogenicity of those compounds.



     The  lifetime cancer  risk  due  to  air  containing  1  |ig/m  of  hexavalent


                                              _2
chromium compounds is estimated to be  1.2 x  10  .   This would place hexavalent



chromium (Cr VI)  in the first quartile of the 53 compounds evaluated by the CAG



for relative potency.
                                     2-11

-------
                           3.   BACKGROUND  INFORMATION








3.1.  CHEMICAL AND PHYSICAL PROPERTIES








     Chromium was  discovered  in 1797  by  the French  chemist,  Louis Vanquelin.




Metallic chromium is steel gray in  color,  melts at 1857 + 20°C, boils at 2672°C,




and has a specific  gravity  of 7.20 at 28°C (Weast,   1980).  As found in nature,




chromium is a mineral mixture of four stable isotopes of mass numbers 50, 52, 53,




and 5M (Gary, 1982).



     The inorganic chemistry of chromium and its compounds has been extensively




studied.  However, its  physical or  chemical forms and  the mode by which they are




incorporated  into  biological  systems are  poorly  characterized.    Inorganic




chromium compounds occur in valence states ranging from -2 to -1-6.




     Chemically,  the  Cr(III)   state  is the  most  stable and  important  form of




chromium.   In  neutral  and basic solutions,  Cr(III)  forms binuclear  and  poly-




nuclear compounds  in which  adjacent  chromium atoms  are linked through hydroxy-




(OH) or  oxo-(O)  bridges.   Interestingly, Cr(III)   forms  stable  complexes with




amino acids and peptides  (deMeester and Hodgson, 1977; deMeester et al.,  1977).




Cr(III) also has a strong tendency to  form hexacoordinated octahedral complexes




with ligands, such as water, ammonia,  urea, ethylenediamine, halides, sulfates,




and  organic acids.   These relatively stable  complex formations  (Cotton and




Wilkinson,  1972; Kiilunen et al.,  1983) can prevent  precipitation of Cr(III) at




pH values at which it would otherwise  precipitate.




     Cr(VI) exists in solution as hydrochromate, chromate, and dichromate ionic




species.  The proportion  of each ion in solution is dependent on pH.  In strongly




basic and neutral pHs,  the chromate form predominates. As the pH  is  lowered, the




hydrochromate concentration increases.  At very low  pHs, the dichromate species






                                       3-1

-------
predominates.  In the  pH  ranges encountered in natural  water,  the predominant



forms are hydrochromate ions (63-6J) at pH 6.0 to 6.2 and chromate ion  (95.7» at



pH 7.8 to  8.5 (Trama and  Benoit,  1960).   The  oxidizing ability  of  Cr(VI) in



aqueous solution is pH  dependent.  The oxidation potential of Cr(VI) increases at



lower pHs.  The ability of Cr(VI) to oxidize organic materials and the tendency



of the  resulting Cr(III)  to form stable  complexes with  available  biological



ligands afford a reasonable mechanism by which chromium  can  interact with the



normal biochemistry of man  (Towill et al.t 1978).



     The physical  properties of several environmentally  significant  trivalent



chromium compounds  are shown in Table  3-1.  The same  parameters for selected



Cr(VI) compounds are shown in Table 3-2.  It should be  mentioned that there is



considerable  disagreement  in the literature concerning  the physical parameters



given in Tables 3-1 and 3-2  and therefore these  values  should be accepted with



reservation.  The disagreement in the values is possibly due to the reactions of



these compounds  with other  substances,  namely  with moisture and air  at high



temperatures,  impurities,  and  structural  and  compositional  changes  occurring



during the experimental determinations.



     Reactions of Cr(III)  in alkaline solution depend on  the concentration  of OH~



ions.  When hydroxyl ions are added to Cr(III)  solutions in quantities insuffi-



cient for  precipitation, basic  ions  are  formed,  which then polymerize with the



formation of  hydroxy- or oxy-bridged compounds as shown below:



        Cr(NO,),	» [Cr(H,0),]3+ -A-2S* [Cr(OH)(H?0),J2+
              -> J             c.  o    r
-------
U)
                                                                              TABLE 3-1

                                                     Physical Properties of Selected Trlvalent Chromium Compounds*
Compound
Chromic acetate
Chromic chloride
Chromic chloride,
hexahydrate
Chromic formate,
hexahydrate
Chromic oxide
Chromic phosphate,
hydrated
Chromic sulfate
Chromic sulfate,
hydrated
Density,
Formula g/cmj
Cr(CH3COO)3 • H20
CrCl3 2.76 (15°C)
[Cr(H20),,Cl2]Cl • 2H20 1.76
[Cr(H20)g]Cl3 NR
[Cr(HCOO)3] • 6H20 NR
Cr_0, 5.21
CrPO.. • 2H,0 2.42 (32.5"C)
CrPOJj • 6h|o 2.121 (14«C)
Cr-CSOj)- 3.012
Cr (S0a), • 15H-0 1.867 (17*C)
Cr^soj)^ • 18H20 1.7 (22°C)
Melting
Point, °C
NR
«1150
83
NR
decomposes
above 300
2266
NR
100
NR
100
100(-12H20)
Boiling
Point, °C
NR
1300
(sublimes)
NR
NR
NR
4000
NR
NR
NR
100(-100 H-0)
NR
Solubility
in Hater, g/100 ml
slightly soluble
insoluble
58.5 at 25°C
soluble
soluble
insoluble
slightly soluble
insoluble
insoluble
soluble
120 at 20eC
       •Source:  Veast,  1980; The Herck Index, 1976
       •• * Vot reported

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                                                                        TABLE 3-2

                                             Physical Properties of Selected Hexavalent Chromium Compounds8
Density,1*
Compound Formula g/cnr
Ammonium chromate (M^). CrO,. 1'^112
Ammonium dichromate (NH^) Cr-0_ 2.155-c
Barium chromate BaCrOH 4.498.,.
H 25
Chromium (VI) oxide CrO^ 2'7025
Lead chromate PbCrO^ ***1215
-«=• Mercurous (I) chromate Hg^rO^ NR
Mercuric (II) chromate HgCrO^ NR
Potassium chromate KjCrO^ 2. 732...,
Potassium dichromate KjCr^O- 2.67&25
Sodium chromate Na^rO,. 2.723,c
Sodium dichromate Na.Cr.O- • 2H.O 2.348..
dihydrate
Melting
Point, °C
180
decomposes
180
decomposes
decomposes
197
844
decomposes
decomposes
971
398
792
84.6
( incongr uent )
Boiling
Point, °C
NR
NR
NR
decomposes
decomposes
NR
NR
NR
500
decomposes
NR
400
decomposes
Solubility in
Water, g/100 ml
40.5 at 30°C
30.8 at 15°C
3.4 x 10"11
at 160°C
67.45 at 1000C
5.8 x 10~6 at
25°C
very slightly
soluble
slightly soluble,
decomposes
62.9 at 20*C
4.9 at 0°C
102 at 100°C
87.3 at 30°C
180 at 20°C
aSource:  Weast, 1980; Hartford, 1979

 The lower figures indicate the temperature (°C) at which the densities were measured.
NR = Not reported

-------
Such ions are  of  the proper size to cross-link  protein  fibers  and may play an


important part in the chemistry of  tanning.   The single  hydroxyl-bridged rhodo


and erythro binuclear Cr(III) amine  complexes  also have been extensively studied


(Veal et al., 1973;  Cline et al.,  1981).


     When a  sufficient  amount  of a  base  is added to Cr(III) salt solution,  a


hydrous oxide of indefinite composition, Cr203»xH20, is precipitated.  On addi-


tion of more base  to  the hydrous oxide,  the precipitate redissolves, probably due

                                                       •3 „
to  formation  of  complex  ions of  the  type  [Cr(OH)x]:>~  (e.g.,   [CrtOH)^]",


[Cr(OH)6]3").


     Cr(III)  compounds   are reduced  to  Cr(II)   compounds by  hypophosphites,


electrolysis,  or  reducing  metals,  such  as  Zn,   Mg,  and  Al  in acid  solution


(although it should be noted that Cr(II) compounds are stable only in  the absence

                                                                         2»
of  air).    In  basic  solution,  Cr(III)   is  readily  oxidized  to  CrOjj    by


hypochlorite,  hypobromite,  peroxide,  and   oxygen  under  pressure  at  high


temperature.  Heating of chromium compounds in air  in  the presence of alkalies


also yields chromate.  In acid  solution, Cr(III)  is harder to oxidize and needs


strong  oxidizing  agents, such  as  concentrated  HCIO^,  sodium  bismuthate,  and


permanganate.


     All Cr(VI) compounds except CrF, are oxo-compounds.  Cr(VI)  rarely occurs in


nature,  apart  from  anthropogenic  sources, because it  is readily  reduced  by


oxidizable organic matter.  However, after it is introduced into water, Cr(VI)


frequently  remains  unchanged  in  many  natural  water  sources  because  of  low


concentration of  reducing  matter.   Cr(VI) occurs most commonly in the form of


chromate or dichromate,  both of which are  produced on a large scale in industry.


The  dissociation  equilibrium  of  chromic acid  solution indicates  the weaker


acidity of HpCrOj..  The dissociation of H^Cr  0   appears  to be that of a strong


acid.  Acid solutions of dichromate are powerful oxidizing agents:
                                      3-5

-------
     Cr20?2" + 1i»H* + 6e"	»• 2Cr1"3 + 7H20, E° = 1.33V



Bichromate salts are the leading commercial form of Cr(VI).








3.2.  PRODUCTION, USE, AND RELEASES TO THE ENVIRONMENT








     The purpose of this document is to present available information relevant to



human health effects that could be caused by this substance.



     Any information regarding sources,  emissions,  ambient air concentrations,



and  public  exposure has  been included  only to  give the  reader  a preliminary



indication of the potential presence of this substance in the ambient air.  While



the  available  information   is  presented  as  accurately   as   possible,  it  is



acknowledged to be limited and dependent in many instances on assumption rather



than specific data.  This information is not intended, nor  should it be used, to



support any conclusions regarding risks  to public health.



     If  a  review  of  the health  information  indicates  that  the  Agency should



consider regulatory  action  for this  substance,  a considerable effort  will be



undertaken  to  obtain appropriate information regarding sources,  emissions and



ambient air concentrations.   Such data  will provide additional information for



drawing regulatory  conclusions regarding the extent and  significance of public



exposure to this substance.








3.2.1.   Production of  Chromium  Compounds.   The industrial  processes  for the




production of chromium metal and  the various compounds have  been described by



Hartford (1979).   A  simplified flow chart depicting these processes appears in




Figure 3-1.



     There has been no mining of  chromite ore  in the United States since  1961.



Chromium ore and  ferrochrome alloys  are imported mainly  from the Soviet Union,



South Africa, Turkey, and Zimbabwe.





                                      3-6

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                        Chromitt
                  
-------
     The two primary industrial compounds  of chromium made directly from chrome



ores are sodium chromate  and  sodium dichromate.  Secondary  chromium  compounds



produced in  substantial  quantities  include potassium  chromate and  potassium



dichromate,  ammonium dichromate, chromic acid, and various formulations of basic



chromic sulfate used principally for leather tanning.   The United Stated manufac-



turers of the three  important chromium compounds, their production capacity, and



the amount  produced  are discussed  below.



     The manufacturers of both sodium chromate  and sodium  dichromate  and their




annual production capacity in 1982 are given in Table 3-3.  The estimated produc-



tion capacity is based on a 100$ sodium dichromate weight.




     The manufacturers of chromic acid and  their  annual  production capacity in



1982 are given in Table 3-**.








3.2.2.   Uses  of  Chromium and Its  Compounds.   The  United  States  consumption



pattern of chromium  and its compounds for  the year 1979 is shown in Table 3-5.



     It  can  be  seen  from  Table 3-5  that metallurgical  and chemical  usages



constituted   82% of the  total United  States  chromium consumption  in  1979.



Metallurgical grade  chromite ore is  usually converted into one of several types



of ferrochromium or other chromium  metal  that  are alloyed with iron  or other



elements, such as   nickel  and  cobalt.   A great  variety  of useful steels are



produced from these  alloys.  Because of their high melting points  and chemical



inertness,  chromite  ore and chrome alloys  are used by the refractory industry in




furnaces as  linings,  in  the manufacture  of furnace bricks,  and as  coating



materials to close  pores  and to  join bricks within the furnace.  Other uses of




chromite refractories include  nonferrous  alloy  refining,  glass  making,  and



cement processing.  The pattern of chromium consumption in the United States has



been consistent over the last 20 years.  However, the use of chromite and chrome
                                      3-8

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                             TABLE 3-3

         Manufacturers and Their Production Capacities of
               Sodium Chromate  and  Sodium Dichromate3
                                     Annual Production Capacity
Manufacturers                        in 1982, 103 metric tons
Allied Chemical Corp.                         65
Baltimore, MD

American Chrome and Chens., Inc.              45
Corpus Christi, TX

Diamond Shamrock                              94
Castle Hayne, NC

     TOTAL                                   201
aSource:   SRI International,  1982;  1982 U.S.  Industrial  Outlook,
Chemical Marketing Reporter, 1982.

 Diamond Shamrock will increase capacity to 118,000 tons in January
1983.
                                3-9

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                       TABLE 3-1

Principal United States Manufacturers of Chromic Acid3'
                            Annual Capacity in  1982,
    Manufacturers              10^ metric tons0
 Allied Chemical Corp.               21
 Baltimore, MD

 Diamond Shamrock Corp.              24
 Castle Haynes, NC
 Source:  SRI International,  1982; Hartford,  1979

 Data on actual production of chromic acid are held  to be
 confidential    to    avoid    disclosing    proprietary
 information on individual  companies.
 Q
 The  estimates  for production  capacity are  based  on a
 100$ chromic anhydride  (CrO  )  basis.
                          3-10

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                                    TABLE 3-5

               United States Chromium Consumption Pattern in  1979a
                                   Quantity Consumed  'c          % Fraction of

                                     10^ metric tons           U.S. Consumption
Metallurgical
  wrought stainless and heat             235                          44
     resisting steels
  tool steels                              6                           1.1
  wrought alloy steels                    44                           8.1
  cast alloy steels                       15                           2.7
  alloy cast irons                         8                           1.4
  nonferrous alloys                       15                      .2.7
  other                                    6                           1.1
    Total                                329                          61.0

Refractories
  chrome and chrome-magnesite             16                           3*0
  magnesite-chrome brick                  23                           4.2
  granular chrome-bearing                 42                           7.8
  granular chromite                       16                           3.0
    Total                                 97                          18.0

Chemicals
  pigments                                29                           5.4
  metal finishing                         24                           4.4
  leather tanning                         18                           3.3
  drilling muds                            5                           0.9
  wood treatment                           7                           1.3
  water treatment                          7                           1.3
  chemical manufacture                     9                           1.7
  textiles                                 4                           0.7
  catalysts                               <2                           0.3
  other                                    9                           1.7
    Total                                114                          21.0

    Grand Total                          540                         100
aSource:  Hartford, 1979, Mineral Commodity Summaries, 1980.

 Exclusive of scrap.

 Columns may not total exactly due to rounding.
                                      3-11

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alloys in the refractory industry is beginning to decline as open hearth furnaces



are replaced by basic-oxygen furnaces (Hartford, 1979).  In the future, growth in



chromium usage is expected in the metallurgical and chemical sectors.   A recent



study (Morning, 1977)  has projected a 3.%% growth annually  in the United States



chromium  consumption,  leading to  a  total chromium  demand of  1 million  tons



(900,000 metric tons)  in the year 2000.



     The consumption pattern of  imported chromium for metallurgical, refractory,



and chemical usage is shown in Table 3-5.  Chromium-containing  pigments can be



primarily  classified   into  chromate  color pigments  based  on   lead  chromate,



Cr(III) oxide greens,  and corrosion inhibiting pigments based primarily on zinc



chromate.  In metal finishing, chromic acid is  used in chromium plating of metal



surfaces.  The chrome  tanning of leather is one step in a complicated series of



operations leading from the rawhide to the finished product.  The annual consump-



tion of hides by the leather industry is decreasing  (Hartford, 1979), and the use



of  Cr(VI) compounds  for tanning  purposes  may be  on  the  decline.   Chromium



chemicals, such as chromium lignosulfonates, are used in  drilling muds during the




drilling  of  wells to  combat  fatigue   corrosion  cracking of  drill  strings



(Hartford, 1979).  Chromated copper arsenate is widely used as a wood preserva-



tive, especially  in treating  building lumber,  and  wood  foundations.  Chroraates



are  used  to inhibit metal  corrosion in  recirculating  water systems,  such as



cooling  towers, locomotives,  and  automobiles.   Sodium dichromate  and various



chromic salts are employed in the textile industry to improve washfastness and to



oxidize  the dyed  textile.   A large number of chromium compounds  are  used as



catalysts in various chemical reactions.  Barium and calcium chromates are used



as  activators and dipolarizers in fused  salt batteries.  Chromium dioxide (CrO )



is  used as a ferromagnetic material in high-fidelity magnetic tapes.
                                      3-12

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3.2.3.   Releases to  the  Environment.   Although  the chromium  industry  in the



United  States  has adopted various pollution  control measures,  some release of



chromium compounds  into the  environment is occurring.  Chromium compounds from



industrial operations enter the environmental air, water, and soil from several



sources.   Kilns,  smelting  furnaces,   boilers,  leaching  tanks,   open  boiling



vessels, plating tanks, and other installations emit dusts and mists containing



chromium to the atmosphere.



     Chromium  is a  trace component of coal  and oil  and  is  released  to the



atmosphere upon combustion of these fuels.  Fly ash emitted from coal-fired power



plants  contain  10  to 600 ppm chromium, depending on the type of boiler firing



(Block and Dams, 1976; Hock and Lichtman,  1982).  For power plants equipped with



electrostatic precipitators  (ESP)  to control  particulate  emissions,  the total



chromium concentration in the emission  can  be reduced (NAS,  197*0.  Rinaldi et



al.  (1980)  have  shown that the  chromium  concentration of  particulates  from



controlled coal  combustion may be  higher  than  the chromium concentration  of



particulates from  uncontrolled  coal combustion,  due to preferential  chromium



enrichment on small particles that escape the ESP device.



     Wood contains chromium and it is  likely  that the burning of wood in fire-



places and campfires  may  contribute  small amounts of chromium  into  the atmos-



phere.  Forest fires would therefore be a potential non-anthropogenic source of



atmospheric chromium (NAS, 197U).  No estimate of the amount of chromium emitted



from  forest  fires  could  be obtained.   However,  Lantzy and MacKenzie  (1979)



estimated chromium  flux  in the atmosphere  from anthropogenic  (industrial and



fossil  fuel)   and  non-anthropogenic   (continental  dust,  volcanic  dust,  and



volcanic gas)  sources.  The  ratio of anthropogenic to non-anthropogenic atmos-



pheric  flux of  chromium was estimated  to be 1.61.   Incineration  of municipal
                                     3-13

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refuse and sewage sludge is also expected to contribute small amounts of chromium

into the atmosphere (Binaldi et al., 1980;  Fiscus et al., 1978).

     It is now known that asbestos contains as much as 0.15$ chromium (Towill et
                                                                      v
al.,  1978).   Thus asbestos mining  and the wearing of vehicular  brake  linings

represent potential sources of chromium in the  atmosphere.   Catalytic emission

control  systems  in  automobiles  using  copper  chromite  reduction  catalysts

represent another source of chromium emissions  to  the  atmosphere  (TABC,  1980).

Also, when chromate chemicals are used  as  corrosion inhibitors in  recirculating

cooling waters, some chromate is lost to the  atmosphere as mist.

     According to a Radian Corporation  (1984) report,  United States industrial

and inadvertent sources of  chromium  emissions into the atmosphere under existing

controlled operations amounted to about 5,000 metric tons.  Estimated amounts of

atmospheric chromium emissions are shown in Table 3-6.

     The  geographical  distribution of  atmospheric chromium  emissions in  the

United States is presented  in Table 3-7.   It  is  evident from Table 3-7 that the

Great Lakes area,  the  Southeast and  the East coast south from New York constitute

the bulk of atmospheric chromium emissions in the United  States.

     Chromium compounds occur in a variety of industrial  wastewaters and poten-

tially  may enter surface  water  and  groundwater  supplies.   Wastewaters  from

electroplating operations,  leather tanning, and  textile manufacturing represent

the types  of  chromium-containing  streams that may  ultimately enter surface and

groundwaters  (Hartford, 1979).  It has  been estimated that 220 metric tons/year

are discharged in Southern California coastal waters (Schafer, 1977).  Ottinger

et al.  (1973) estimated that  6200 metric  tons of chromium are lost annually in

the sludge of solvent-based paints and another 437 metric tons are  discharged as

paint residues.

-------
                                  TABLE 3-6

    Sources  and  Estimates  of United  States  Atmospheric  Chromium  Emissions*
     Source Category                  Chromium Emissions, Metric Tons/Year


Chrome Ore Refining                                     3

Ferrochromium Production                               13

Chromium Chemicals Production                     M50-900

Refractory Production                                  90

Sewage Sludge Incineration                             25
                                                       30

Steel Production                                     2870

Utility Cooling Towers                                  5

Cement Production                                      16

Combustion of Coal and Oil
     boilers                                          737
     process heaters                                  556

     Total                                      4525-5275


•Source:  Radian Corporation, 1984
                                      3-15

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                                    TABLE 3-7

             Regional Distribution of Principal Chromium Emissions'
EPA Region/States
I/CT,ME,MA,NHtRI,VT
II/NJ,NY,PR,VI
III/DE,MD,PA,VA,WV,DC
IV/AL,FL,GA,KY,MS,NC,SC,TN
V/IL,IN,MI,MN,OH,WI
VI/AR,LA,NM,OK,TX
VII/IA,KS,MO,NB
VIII/CO,MT,ND,SD,UT,WY
IX/AZ,CA,NV,HA
X/AK,ID,OR,WA
TOTAL
Annual Chromium Emissions
From Sources in this Region,
metric tons (Mg)
103
3,140
2,800
3,000
4,830
74
177
107
174
898
15,300
Percent of Total
U.S. Chromium
Emissions
0.6
19.0
17.3
18.5
29.0
0.5
1.1
0.7
1.1
5.4
93.2
 Source:  OCA Corporation,  1973

 Sources include ferrochrome production,  refractory production,  cement production,
chrome steel production,  and coal and oil combustion.
                                       3-16

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     Solid waste streams containing Cr(VI) constitute  the  primary  problem area



involving chromium solid  wastes (Hartford,  1979).   Wastes resulting  from  the



roasting and leaching steps in the chromate manufacturing process traditionally



contain residual Cr(VI).   If  landfilled,  the residual Cr(VI) can  slowly  leach



into surrounding waters via desorption and disproportionation (Hartford, 1979).



An estimate of the total amount of chromium released into soil and groundwater as



a result of the leaching of chromium-containing solid wastes is  not available.








3.3.  ENVIRONMENTAL FATE AND TRANSPORT







3.3.1.  Air.  Little  information exists in the literature  regarding the nature of



the chemical  species present in  the  atmosphere away  from obvious sources  of



pollution.  Under normal conditions, Cr(III)  and Cr(0) are relatively unreactive



in  the  atmosphere   (Towill  et al.,   1978).    Cr(VI)  in  air  may  react  with



particulate matter or gaseous pollutants to form Cr(III)  (NAS,  1974).   However,



these atmospheric reactions have not been extensively studied.



     Low concentrations of chromium enter the  atmosphere as a  result  of indus-



trial activities and soil-derived aerosols  (Towill et  al.,  1978).   Chromium is



removed from air through wet and dry depositions.  The total  yearly deposition of


                                                 2           2
chromium in urban  areas may  vary  from  0.12 pg/m  to  3  pg/m   (Towill  et al.,



1978).   In  general,  urban  areas have  higher total deposition than rural areas.



Chromium concentration  in  a wet deposition may vary from  0.004  to  0.060  pg/m&



and 0.0006 to 0.034 pg/fc for urban and rural  areas, respectively  (Towill et al.,



1978).  The precipitated chromium from the air enters the surface water or  soil.



     Chromium  particles of aerodynamic  equivalent  diameter <20 pm may remain



airborne for long periods and may be transported great distances by wind currents
                                      3-17

-------
and  diffusion forces  (Sehmel  and  Hodgson,   1976).    Therefore,  atmospheric



conditions  play  an  important  role  in  determining  the chromium  concentration



around emission sites;  however,  no data relating atmospheric chromium content to



atmospheric or meteorological conditions could be found in the literat\ire.








3.3.2. Water  and Sediments.  Surface  runoff, deposition from air, and release of



municipal  and industrial  wastewaters are  the sources  of chromium  in  surface



waters.  Chromium may  be transported in  five  forms  (see Table  3-8)  in  surface



waters.




     It can be seen  from Table  3-8 that  most  of  the chromium in surface waters



may be present in particulate form as  sediment.  Some of the particulate chromium



would  remain  as suspended  matter  and  ultimately be  deposited  in  sediments.



DeGroot and Allersma (1973) found a chromium ratio in water to suspended matter



to be  1 to 2.3 for the Rhine River.   In the heavily polluted Qishon-Gadura River



in  Israel, chromium concentrations in water  were  <10   ppb,  while  sediment



contained from 220 to 610 ppm chromium  (Towill et al., 1978).




     The exact chemical forms of chromium in surface waters are not well defined.



Although most of the soluble chromium in surface  water may be present as Cr(VI)



(Towill et al., 1978), a small amount  may  be present as Cr(III) organic complexes



(DeGroot and Allersma, 1978; Fukai,  1967).  Schroeder and Lee (1975) studied the



transformation between Cr(III) and Cr(VI) in  natural waters.   They  found  that



only 3$ of Cr(III)  was oxidized by  0  in 30 days at ambient temperature.  Cr(VI)



is the major stable form of chromium in  seawater  (Fukai,  1967);  however, Cr(VI)



may be reduced to Cr(III)  by organic  matters present in water and may eventually



deposit in sediments.  Lu and Chen (1976) found that  chromium was not signifi-



cantly released from sediments into seawater under either  oxidizing or reducing



conditions.  Eisenreich (1982),  however,  noted that in some waterbodies,  such as
                                     3-18

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                                    TABLE 3-8




       Five Forms of Chromium Transported in the Yukon and Amazon Rivers*
Physical Form
In solution and organic complexes
Adsorbed
Precipitated and co-precipitated
In organic solids
In sediments
Percent Present
In
Amazon River Yukon River
10.4
3.5
2.9
7.6
75.6
12.6
2.3
7.2
13.2
61.5
•Source:  Towill et al., 1978
                                      3-19

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Lake Superior, chromium  occurred  in trace amounts from  in-lake  processes.  He



estimated an atmospheric chromium flux of 0.9 Hg/m /day on the surface film.
3.3.3.  Soil.  Most soil  chromium is in mineral, absorbed, or precipitated form.



Chromium probably occurs as the insoluble Cr(III) oxide  (Cr 0-«nH_0) in soil, as



the  organic matter  in  soil  is expected to  reduce any  soluble chromate  to




insoluble Cr20-.  Chromium in  soil can be  transported to the atmosphere by way of



aerosol formation  (John  et  al.,  1973; Zoller et al., 1971).   Chromium  is also



transported from soil through runoff and  leaching of water.  Runoff could remove



both chromium  ions  and bulk precipitates of chromium with final  deposition on



either a different land area or a water body.  In addition,  flooding of soils and



the subsequent anaerobic  decomposition of plant matters may increase dissolution



of Cr(III) oxides in the soil  (Towill  et al., 1978).








3.4.  LEVELS OF CHROMIUM IN VARIOUS MEDIA








3.1.1.  Ambient Air. Background concentrations of chromium  in various media have




been reported by Cary (1982).   Citing the work of Maenhaut and Zoller (1977), he



noted chromium concentrations  at the South Pole were approximately 5 pg/nr (0.005



ng/m ).  He noted further that Duce and Zoller (1975)  found  that chromium levels



over the Atlantic  Ocean  ranged from 0.007 to  1.1  ng/nr.   The  authors believed



that this trace amount of chromium originated from  a  crustal  source.



     The chemical form of chromium in air depends on the source  of emission.  The



majority  of chromium  in  the atmosphere,  originating  from  such  sources  as



metallurgical  production,  coal  and  oil  combustion  and  cement production  is



usually in the Cr(III) or Cr(0) state.   Chrome  production, chrome  plating,  and



cooling tower  drifts are  primary examples  of the  sources  of  Cr(VI)  in  the
                                     3-20

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atmosphere (Towill et al., 1978).  The mass  median  diameter of chromium in air



particulate matter is  in the range of 1.5 to  1.9 nm  (Cawse,  1974;  Lee and von



Lehmden, 1973).  Chromate salts are often used  in the  cooling tower water as a



corrosion  inhibitor.    Therefore,  cooling  tower  drift  consisting of  water



droplets formed  mechanically within the  towers and carried  by wind  into the



surrounding area may be a source of high Cr(VI)  concentrations in air.   Air



concentrations  of chromium  near a  cooling  tower  at  the  Oak Ridge  Gaseous



Diffusion Plant, Oak Ridge, Tennessee, were about 50 ng/nr from distances up to



660 feet (200  m) from the tower (Alkezweeny et al.,  1975).   Hourly  chromium


                           2                                      2
deposition was about 1 mg/m  at 100  feet  (30  m)  and  about 0.01 mg/m  at 330 feet



(1000 m) from  the tower.   Therefore,  substantial  amounts  of chromium  may  be



present  in  the  respirable  particulate  fraction  and  can  be deposited  in the



respiratory tract.



     The concentrations  of total chromium measured in the  ambient  air of many



urban and nonurban areas of the United States during  1977  to 1980  are  given in



Table 3-9.   The data in Table  3-9  were  obtained from the  U.S.  EPA's  National



Aerometric Data Bank, which  is  maintained by the Agency's  Monitoring  and Data



Analysis Division (MDAD) at Research Triangle Park,  North Carolina.  None of the



data in Table 3-9 have been previously published. The ambient chromium data have



been collected  by monitoring networks  operated by  various  State and local air



pollution control agencies  as required  by  the Clean  Air  Act.   After  passing



editorial and validation checks  which are performed  by  EPA regional offices, the



data are forwarded to MDAD for  incorporation into the  National  Aerometric Data



 Bank.



     During the  1977-1980 period, the mean chromium concentrations  measured in



the United  States (given in Table  3-9) ranged from 0.0052 |ig/nr (24-hour average
                                     3-21

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                        TABLE 3-9

Total Chromium Concentrations Measured in the Ambient Air
 of Selected Sites in the United States During 1977-19803
Site
Grand Canyon, National Park, AZd
Los Angeles, CA
Waterbury, CT
Atlanta, GA
Hawaii County, HI
Kansas City, KS
Iberville Parish, LA
Acadia National Park, MEC'd
Baltimore, MD
Worcester, MA
Bayonne, NJ
Newark, NJ
Niagara Falls, NY
Year
1977
1977
1978
1979
1977
1980
1977
1977
1978
1980
1977
1978
1980
1977
1977
1979
1977
1978
1979
1977
1978
1980
1978
1979
1980
1979
1980
Total Chromium
Arithmetic
Mean
0.0058
0.0188
0.0342
0.0326
0.0089
0.0062
0.0063
0.0167
0.0276
0.0191
0.0063
0.0059
0.0052
0.0052
0.1568
0.0935
0.0063
0.0099
0.0067
0.0105
0.0149
0.0123
0.0181
0.0129
0.0091
0.0389
0.0144
Concentration, pg/m
Maximum Observed
Value0
0.0134
0.0666
0.2178
0.1396
0.0441
0.0194
0.0216
0.0413
0.0724
0.0358
0.0159
0.0128
0.0052
0.0052
0.2470®
0.4589
0.0167
0.0239
0.0166
0.0253
0.0324
0.0508
0.0301
0.0333
0.0369
0.5590
0.0603
                           3-22

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                                 TABLE 3-9 (cont.)
Site


Akron, OH




Cincinnati, OH




Steubenville, OH


Black Hills National Forest, SDC

Chattanooga, TN




Norfolk, VA




Tacoma, WA
Year
                                              Total Chromium Concentration, pg/nT
                                              Arithmetic       Maximum Observed
Mean
                                                    b
Value
1977
1978
1979
1980
1977
1978
1979
1980
1978
1979
1978
1977
1978
1979
1980
1977
1978
1979
1980
1977
1978
1980
0.0126
0.0188
0.0166
0.0201
0.0083
0.0116
0.0451
0.0150
0.0517
0.1212
0.0090
0.0122
0.0140
0.0112
0.0150
0.0067
0.0069
0.0083
0.0119
0.0099
0.0249
0.0104
                               0.0610
                               0.0528
                               0.0389
                               0.0710

                               0.0377
                               0.0294
                               0.4316
                               0.0718

                               0.2602
                               0.6839

                               0.0295

                               0.0453
                               0.0463
                               0.0760
                               0.0705

                               0.0152
                               0.0158
                               0.0291
                               0.1456

                               0.0330
                               0.1425
                               0.0283
a
 Source:  Unpublished data in the National Aerometric Data Bank maintained by
the Monitoring and Data Analysis Division of EPA, Research Triangle Park, NC.

 Values represent annual average.

CValues represent maximum 24 hour averages.
 Background sites; all other sites are determined to be populated urban areas,

Corrected from Maryland State Yearly Air Quality Data Report, Baltimore MD,
March, 1978.
                                        3-23

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background  level)  to  0.1568  ug/m3  (urban annual average).  The highest maximum



24-hour  average  of 0.6839 ug/m3 was recorded in Steubenville, OH in  1979.  For



the  sites  with  >2 years  worth of  data, no  discernible  upward  or downward



concentration trends are  evident.  For example, in Newark, New Jersey, the mean



chromium concentration dropped from 0.0181 ug/m3 in  1978 to 0.0129 ng/m3 in 1979



and to 0.0091 ug/nr in 1980.   However, in Norfolk, Virginia,  over the same period



the chromium levels rose from 0.0069 ug/m3 in 1978 to 0.0083 pg/m3  in 1979 and to



0.0119 mg/ar in  1980.  In Akron, Ohio,  the mean chromium concentration in 1978



was determined to be 0.0188  ug/m3.  In 1979, the concentration in Akron dropped



to 0.0116  ug/m3  but in 1980 it  rose again to  0.0201 ug/m3.   The mean chromium



concentrations in nonurban, background areas such as national parks ranged from



0.0052 ug/m3 to 0.0090 ug/m3 over the 1977 to 1980 period.




     Some  source  categories emit  trivalent  chromium,   some  emit  hexavalent



chromium  and others  emit a combination  of the two.    Sources  likely to  be



trivalent  emitters  are refining,  cement production  and  coal and  combustion.



Hexavalent  sources include chrome  plating  and  cooling towers.   Those  that emit



both forms  include chromium  chemicals production, refractory  production,  steel



manufacturing,   and sewage  sludge  and  municipal  refuse incineration.    The



relative proportions of each form  emitted are  unknown  at this time.   Maximum



annual average concentrations predicted, based  on dispersion  modeling,  with  20



km of these source categories range from 0.01 ug/m  for refractory production.



3.4.2.   Aquatic  Media.   Naturally  occurring chromium concentrations in  water



arise from  the weathering  of minerals, soluble  organic  chromium,  sediment  load



and precipitation (Cary,  1982).   Of 170 lakes sampled in the Sierra mountains  in



California, only two contained up to 5 ug/S, (ppb) chromium;  the mean pH  was 6.0



(Cary,  1982).    Both   the  Amazon  and  Yukon  rivers, which  are  considered  to



represent unpolluted watershed  systems,  reportedly  contained 2.0 and 2.3  ug/Jl
                                     3-24

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(ppb)  chromium,  respectively   (Gibbs,   1977).    These  background  freshwater



chromium levels compare well with  estimates  given  by Bowen (1979)  (median of 1



pg/Jl  (ppb)  chromium  within a range  of  0.1 to  6 pg/Jl (ppb)).   Morevoer,  Gary



(1982) notes that over  35%  of the  stream and river water sampled in Canada for



chromium contained less that 10 pg/Jl  (ppb).  The chromium levels detected in a



few surface waters and groundwaters are  presented in  Table  3-10.  The amounts of



chromium  found  in  these  waters  are  usually  related  by  the  authors  to



anthropogenic input.  For  example,  it has  been shown by Kopp and Kroner (1967)



that water from Lake Michigan near industrial discharge points contained a higher



level of chromium than lake water contaminated with lesser industrial input  (5 to




19 ppb, compared to 2 to 1 ppb).



     The valence of chromium in surface water can be  either VI or III.  Although



Cr(VI) is the more stable species in seawater,  Fukai  (1967)  provided data to show



that both Cr(III) and Cr(VI) were  present.  Surface seawater contained Cr(III)



and Cr(VI)  in the range of 0.02 to 0.11 ppb and 0.28 to 0.36 ppb, respectively,



while  seawater  at  depths  of 5,  500, and  1000 m contained  about the same level



(0.2  ppb)  of Cr(III) and  Cr(VI).   Cranston  and Murphy (1978)  found  that the



ratios increased at  depths  greater than 100 m.  In areas of the Pacific Ocean,



chromium levels averaged 0.12 pg/Jl  (ppb).  Above 100 m, 83$ occurred as Cr(VI);



below  100  m  chromium  averaged  0.16  pg/Jl  (ppb),  and  CR(VI) accounted  for



approximately 90$.



     In a  survey of 14 groundwater and  69 surface water supplies  in 83 United



States cities  in Illinois, Indiana, Michigan,  Minnesota,  Ohio, and Wisconsin,



the chromium level in the raw waters used for  drinking waters were found to range



between  <5.0 and  17.0 ppb  (see  Table  3-11)  (U.S.  EPA, 1975).   Groundwater



contamination of 220 pg/Jl (ppb)  Cr(VI) was  reported by Robertson (1975) in ground




water  of Paradise Valley,  AZ.
                                      3-25

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                                    TABLE 3-10
            Chromium Levels in a Few Surface Waters and Groundwaters4

Source
Lake Tahoe
Colorado River
Columbia River
Mississippi River
Missouri River
Ohio River
U.S. surface waters
U.S. surface waters
Natural water, Oak Ridge, TN
Water near cooling tower,
Oak Ridge, TN
Uncontaminated stream, NY
Contaminated stream, NY
Uncontaminated well, NY
Contaminated well, NY
Illinois River
Spring water, CA
Well water, CA
Stream water, CA
Seawater, CA
Frequency of
Detection %
NR
12
87
23
10
20
25
25
NR
NR
NR
NR
NR
NR
NR
6
5
0
0
Cone, (ppb
with Detec
Average
<0.62
NR
NR
NR
NR
NR
<1
9.7
NR
NR
<10
1250
<10
6000
21
NR
NR
NR
NR
or pg/fc) in Samples
table Chromium Level
Range *
<0.07 to <0.91
10 to 30
1 to 10
3 to 20
8 to 10
i| to 16
<1 to 19
1 to 112
50 to 120
2500 to 2790
NR
NR
NR
NR
5 to 38
0 to 21
0 to 13
NR
NR
aSource:"  Towill et al.,  1978
NR = Not recorded
                                       3-26

-------
                                   TABLE 3-11

                Chromium Concentrations in U.S. Drinking Waters'
                                            Concentration, pg/& or ppb
    Water
Tap water, Dallas, TX

100 largest cities, U.S. (1962)

380 finished waters, U.S.
  (1962-1967)

3834 tap waters, U.S.
  (1974-1975)°

83 Midwestern cities, U.S.6

115 Canadian municipalities
  (1976-1977)
             r
Median
4b
0.4°
K
7.5b
Range
1 to 20
0.2 to 35

1 to 29
1.8°

NR


<2.0
 0.4 to 8S

<5.0 to 17.0


 <2.0 to 4.1
aSource:  NAS, 1977
 Average value; sampling date unavailable

cMedian value

 Greathouse and Craun, 1978

eU.S. EPA, 1975; sampling date unavailable
fMeranger et al., 1981

g28$ of areas had detectable levels
NR = Not recorded
                                       3-27

-------
     The chromium concentration in various United States drinking water supplies



is presented in Table 3-11.  In a survey  of  2595 water samples from  969  water



supplies in the United States, only four samples showed chromium levels above the



detection limit of 50 ppb (McCabe et al., 1970).  The maximum  chromium concen-



tration in water detected in this  survey was  80 ppb.



     In a more recent survey (197*1 to 1975) with  an analytical  method  of better



sensitivity, 3834 tap waters from 35 geographical locations representative  of



the U.S.  population were monitored  for metal content  (Greathouse and  Craun,



1978).  The detection limit  for Cr in  this survey was  0.1  ppb.  The results of



this  survey,  presented   in  Table  3-11,  also indicated  that  28J  of the  area



surveyed had Cr levels above the detection limit.  It  should be mentioned that



the mean value  of Cr in this study may be a little higher than reported since the



tap waters were not adequately flushed  before collection.








3.4.3.  Aquatic Suspended Materials and  Sediments.  The concentration of chromium



in suspended materials in several United States rivers was found to range between



37 and 460 ppm on a  dry  weight basis (Turekian and Scott,  1967).   Chen  et al.



(1974) determined the concentration  in dry  season suspended silts  of Southern



California waters to be  =500 ppm  in  "natural" areas  and 2000  ppm  in  urbanized



areas.



     Chromium  concentrations determined  for  a variety of  bottom sediments are



shown in  Table 3-12.   For the areas  in the United States sampled,  sediment




chromium levels  ranged  from about  1  to 450 ppm.  An examination of Table 3-12



shows that the chromium  concentration in sediments from several Wisconsin lakes



and Southern Lake Michigan does not significantly decrease with  depth.  A similar



finding concerning sediment chromium content was made by Bruland et al. (1974)



upon  the analysis of chromium levels in sediments of different depths from the
                                      3-28

-------
                                   TABLE  3-12

                     Concentration of Chromium in Sediments*
   Area
Delaware Bay

New York City Bight:
  Background
  Sludge dumping area
  Puget Sound

Houston ship channel, TX

Neches River, TX

Sabine River (low in
  industrial activity)
  TX-LA Border

Southern Lake Michigan:
  surface sediments
  sediments from >15 to
    100 cm depth
  estimated background

Illinois River

Non-industrial stream, IL

Buzzard Bay, MA

Wisconsin Lakes:
  surface sediment
•Source:  Towill et al.,  1978
NR s Not recorded
Chromium Concentration (ppm)

Median                Range
                                             NR
                    33 to
106
a 105
NR
, TX NR
NR
NR
y)
an:
77
to 52
nd NR
17
m, IL 6
33
NR
cm depth NR
2 to 310
50 to 209
43 to 154
39 to 254
8 to 288
41 to 89
35 to 165
32 to 68
20 to 40
2 to 87
3 to 7
NR
1 to 49
0.8 to 35
                                    3-29

-------
Southern California basin.   These studies of sediment chromium  content versus



depth  appear  to  indicate  that natural  background  chromium levels  contribute



heavily to the chromium levels found in surface sediments.



     The  concentration  of chromium  in  an  incinerated sewage  sludge" ash  was



determined to be 5280 pg/g (ppm).  The concentrations  of  metals  in ash residue



after  incineration is «4  times those present in dried sludge  (Fraser and Lum,



1983).  Therefore, based on this  one analysis,  sewage  sludges  may  contain high



concentrations of chromium.








3.4.4.  Soil.  The concentration  of  chromium in soil varies in accordance with



soil origin.  Soils derived from nonserpentine areas can contain from traces to



300 ppm chromium.  Soils derived  from  serpentine areas  can contain up to 2% by



weight of chromium.  The chromium concentrations in selected soils  from various



parts  of  the  U.S. are shown  in Table  3-13.   Mean chromium  levels in Canadian



soils  were  13  ppm (McKeague  and Wolynetz, (1980).   Most  chromium in  soils is



apparently  insoluble.   Extraction  of soils  with 2.5%  acetic  acid,  ammonium



acetate at pH 4.8, and even with 0.1  N HC1 have shown  that  only  0.01 to 4$ of the



total  soil  chromium is extractable  (Towill et al.,  1978).  Generally, chromium



concentrations in soils correlate well with chromium concentrations  in parent



rock (Gary, 1982).








3.^.5.   Food.   The chromium content  of a  variety of  foods  is  presented in



Table  3-14. The  values given in Table 3-14 represent  the average of several food



items-  in  each category.   It can be  seen  from this  table that  the chromium



concentrations in different  categories of food determined by  Schroeder  et al.



(1962) were lower than the values determined by other investigators.  It is not



known  whether  the  observed discrepancies are due to geographical  and seasonal
                                      3-30

-------
                                TABLE  3-13

             Chromium  Content  in Selected United  States'  Soils*
Location
Pennsylvania


Peninsular Florida

Florida

Missouri

New Jersey

Michigan
     Soil
Characteristic
agricultural surface
and subsoil

surface and subsoil

surface and subsoil

on and off road soil

various soils

various surface soils
•Source:  Towill et al.f 1978
NR = Not recorded
  Chromium content
     ppm or pg/g
Range           Median
    NR


 <1 to 1000

 <1 to 500

    NR

 29 to 75

3.2 to 17.6
50

NR

71

NR

NR
                                    3-31

-------
                               TABLE  3-1*1

                 Chromium Content  in  Various U.S.  Foods
Sample
Mean Concentration
  (ppm or pg/g)
Reference
Fresh vegetables
Fresh vegetables
Fresh vegetables
Frozen vegetables
Canned vegetables
Fresh fruits
Fresh fruits
Fruits
Canned fruits
Dairy products
Whole fish
Meat and fish
Meat and fish
Sea foods
Sea foods
Grains and cereals
Grains and cereals
Fruit juices
0.14
0.03 to 0.05
0.14
0.23
0.23
0.09
0.19
0.02
0.51
0.10
0.05 to 0.08
0.23
0.11
0.12
0.47
0.04
0.22
0.09
Thomas et al. , 1974
Schroeder et al., 1962
Toepfer et al., 1973
Thomas et al., 1974
Thomas et al., 1974
Toepfer et al., 1973
Thomas et al. , 1974
Schroeder et al., 1962
Thomas et al. , 1974
Schroeder et al., 1962
Okuno et al., 1978
Toepfer et al., 1973
Schroeder et al., 1962
Zook et al. , 1976
Meranger and Somers, 1968
Schroeder et al., 1962
Toepfer et al. , 1973
Meranger, 1970
                                   3-32

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variations in  trace  element content of  foods or due  to errors in  analytical




determinations.



     The chromium content in acidic foods is often higher than other categories




of foods.  The values of Cr content in a few  commercial  acidic  foods which had




been in contact with stainless steel surfaces during harvesting, processing, or




preparation  for market  are  shown in  Table  3-15  (Stoewsand  et al.,  1979).




Jennings  and  Howard  (1980)  reported  slightly higher  levels of Cr  in British




commercial alcoholic beverages  than the  Cr content  in U.S.  wines as  given in




Table 3-15.  The chromium contents in wines, beers, and spirits were reported to




be 0.45, 0.30, and 0.135 mg/Jl (ppm), respectively.  However,  it is difficult to




assess  the  daily chromium  intake  in the United  States from the Cr  content in




individual  foods.   The  chromium contents  in a  selected  diet composite  were




determined by  Kumpulainen  et al.   (1979).  This  study is  the  most recent diet



study conducted  by FDA-USDA (personal communication  with Dr. W.R.  Wolf, USDA).




The chromium intake from  typical  American diets containing 43? fat was determined




to  be  62 + 28 pg/day.    The corresponding  intake from typical American  diets




containing 25% fat was determined to be 89 ± 56 pg/day.








     3.4.5.1.  BIOCONCENTRATION  IN FOOD CHAINS — Several  authors have found that



chromium  concentrations  decrease in higher trophic  level  organisms  in aquatic




ecosystems  (Towill et al., 1978).   For  example,  Mathis and  Cummings (1973)




detected =10 ppm chromium in worms,  -5 ppm in clams, =1.2  ppm  in omnivorous fish,




and =1 ppm in carnivorous fish.  Lack of assimilation  of chromium is probably the




major  reason that the  organisms of the higher  trophic levels contain lesser




amounts  of chromium.




     A  bioconcentration  factor  (BCF)  is the  ratio  of the  concentration  of a




chemical in aquatic species to the concentration in the  water  in which they live.
                                      3-33

-------
                                 TABLE 3-15

     Concentration of Chromium in a Few Commercial Grade Acidic Foods3
Commodity


Red cabbage

Red cabbage brine

Sauerkraut

Sauerkraut brine

Sauerkraut


Sauerkraut brine


Different brand
 of honey

Vinegar

Hard cider

Cheese whey

Wine, Catawba


Wine, red concord


Wine, red concord
Container
glass
glass
can
can
flexible
pouch
flexible
pouch
glass
bulk
bulkb
bulk
lastiglass
(1 year)
redwood
(8 months)
stainless
steel
(7 months)
Sample
pH
—
3.4
—
3.5
—
3.5
3.5 to 3.7
2.8
3.5
1.8
3.1
3.2
3.2
Cr Concentration,
ppm or pg/g (wet wt.)
2.6
10.3
0.3
0.3
0.2
0.2
O.OM to 0.18
0.01
0.001*
0.01
0.02
0.07
0.02
a
 Source:  Stoewsand et al., 1979
'Before acidification
                                    3-31

-------
An appropriate BCF can be used with data  concerning food intake to calculate the



amount  of chromium  which  might be  ingested  from the consumption  of fish and



shellfish.   Residue data  for a variety  of inorganic compounds  indicate that



bioconcentration  factors  for the  edible  portion of  most aquatic  animals  is



similar,  except  that  for  some  compounds  bivalve  molluscs  (clams,  oysters,



scallops, and mussels) should be considered a separate group.   An analysis  (U.S.



EPA,  1980b)  of data  from a food survey was used to estimate that the per capita



consumption  of  freshwater  and  estuarine  fish  and  shellfish  is  6.5 g/day



(Stephan, 1980).  The per capita consumption of bivalve molluscs is 0.8 g/day and



that  of all  other freshwater  and estuarine fish and shellfish is 5.7 g/day.




      The BCF for  Cr(VI)  in fish muscle appears to be  less than  1.0 (Buhler et



al.,  1977; Fremm and Stokes,  1962), but values of 125 and  192 were obtained for



oyster and blue mussel, respectively (U.S.  EPA,  1980c).  For Cr(III), BCF values



of  316,  153,  and  86  were   obtained  with  the  American  oyster (Shuster and



Pringle, 1969), soft shell clam,  and blue mussel (Cappuzzo  and  Sasner, 1977),



respectively.   It appears  that the two  valence states of chromiumdll  and VI)



have about the same BCF values, and that the geometric mean of  130 can be used for



•bivalve molluscs.  If the values of 0.5 (BCF for fish and mussels) and 130 (BCF



for bivalve  molluscs) are  used with the  consumption  data,  the weighted  average



bioconcentration factor for chromium in the edible portion of all freshwater and



estuarine aquatic organisms consumed by Americans  can be calculated  to be 16 on



the  basis  of per capita  consumption  of  0.8 g/day  and  5.7 g/day  for  bivalve



molluscs, and fish and shellfish, respectively (U.S.   EPA, 1980b).








3*4.6.  Cigarettes.   Chromium has  been  determined  to be a component of cigarette



tobacco.  Tobaccos grown  in the United States have  been found  to have a chromium



content ranging from 0.24 to  6.3 mg/kg  (ppm) (IARC,  1980).
                                      3-35

-------
3.5. INDICES OF EXPOSURE



     Past exposure to low levels of chromium may be associated with higher than



normal levels of chromium in the blood,  urine  and  hair.   In  hair  samples,  the



relationships are tenuous in young children and women,  as a result  of variation



in chromium levels related to age and  pregnancy  (Creason et al., 1975).  In blood



and urine, marked variations have been reported  in the linearity between exposure



levels and the levels in body fluids as a result of sequestering and release of



chromium from body depots.








3.5.1.  Chromium in  Blood.  Chromium is absorbed through both the respiratory and




gastrointestinal tracts (U.S. EPA, 1978).  In  the  respiratory tract,  water and



serum soluble chromates  are  absorbed into the blood system,  whereas  insoluble



Cr(III) particles and the inert oxides and hydroxides of Cr(III) remain in lung



tissue (U.S. EPA, 1978).  In the blood  stream, chromium compounds  are bound by



proteins  (Gray  and  Sterling,  1950).   It  has  been  shown  that ionic  Cr(VI)



(injected intravenously) passes through the membrane of red blood  cells and binds



to  the globin  moiety  of  hemoglobin.   Once  inside the  erythrocyte,  Cr(VI)



compounds are rapidly reduced to Cr(III)  and  are  unable to pass through the cell



membrane (Aaseth et al., 1982;  Yamaguchi et  al., 1983).  In  healthy red cells,



Cr(III) is partially bound to hemoglobin  and  partially to small molecular weight



substances.



     Chromium disappears quickly from the blood and is taken up by other tissues



in the body, where it is concentrated much more heavily (by a factor of 10 to 100)



than  in  the blood.    Therefore,  blood levels  of chromium  may not  be  a usable




indicator  of chromium  nutritional  status  (Mertz,  1969;  Mertz and  Roginski,




1971).



     A wide range  of values for  chromium content  in blood  has  been reported.



Schroeder et al. (1962) reported chromium levels in serum ">f 0.52 and 0.17 ppm,






                                      3-36

-------
whereas Doisy  et  al.  (1969, 1971) found a  chromium concentration of  2  ppb in




serum.  Other chromium values reported have ranged from 0.11 to 55 ppb in human




plasma, and from 5 to  51*  ppb in red blood cells (Underwood, 1971).  Imbus et al.



(1963), working with United States subjects, found blood chromium levels ranging




from 13 to 55 ppb with a median of 27  ppb, while Hamilton et al. (1973), studying




subjects  from the United Kingdom, reported a blood level of 70 ppb chromium.




     However, researchers have discovered, through the use of new technology in




flameless AAS analyses, that the  amount  of chromium in normal blood and urine was




an  order  of magnitude lower than  previous measurements had shown.    It  was




considered by Guthrie  et al. (1978), Kayne et al. (1978) and  Anderson (1981) that




measurements made  before 1978 are probably high as  the result  of  inadequate




background correction  for non-atomic  absorption.  Thus, measurements of absolute




values of chromium in normal body fluids made before 1978 are unreliable (Toxic




Material  News, 1982),  although   they  were useful  as  pioneering attempts  to




elucidate chromium metabolism.




     Kayne et al. (1978) used flameless  AAS  with a tungsten halogen light source




for background correction to determine the serum chromium levels in 8 normal male




subjects.  The tungsten halogen light greatly improved the background correction




in the near UV region where chromium is detected as compared to the standard D




light source.  With the elimination of non-atomic absorption, the mean level of




serum  chromium was determined to be  0.1^1 ug/Jl  (ppb).   These results  were  in




agreement  with those  of Versieck et al.  (1978) in  which serum  chromium  was




determined  by  neutron  activation analysis.   Serum obtained  from 20  healthy




subjects  (duplicate samples from  11 subjects) had a range  of  chromium levels from




0.0382 to 0.351 pg/£ (ppb) with a  mean value of 0.16 pg/Jl (ppb).  Using this data,




the  authors  concluded that  normal  human chromium  levels in serum are  in  the




sub-ppb range.  Plasma or whole blood chromium levels have ranged from U-70 ppb,




with a mean value of 30 ppb  (total chromium) (Lin, 1983).
                                      3-37

-------
3.5.2.  Chromium in Urine.  A wide range of values for chromium content in urine



has been reported.  Hambidge  (1971) reported chromium levels in urine of 8.4 ppb



for adults and 5.5 ppb for  children over a 24-hour period.  Imbus et al.  (1963)



reported median urinary concentrations of chromium for adult males of^3.77 pg/fc



(ppb).  Renal excretion is the major pathway of chromium elimination, with >BO%



of injected chromium excreted in this manner (Mertz, 1969).



     As discussed with chromium levels in serum, difficulties in determining the



low levels  of chromium in urine  were not resolved until  1978,  and  presently,



normal  human  levels  of  chromium are considered  to  be in  the sub-ppb  range



(Anderson,  1981).  Using  flameless  AAS with background  correction by  either a




tungsten halogen  lamp or  a continuum source, echelle,  wavelength modulated AA



system  (CEW-AA), normal human  urinary  chromium  levels  were determined  to be >1



pg/A (ppb) (Guthrie et al., 1978), >0.9 pg/& (ppb) for most  of 66 samples (Kayne



et al., 1978),  and between 0.05 to 0.58  pg/£,  (ppb) for 48  males and  28 females



(Anderson et  al.,  1982).   Veillon et  al.  (1979) obtained  excellent agreement



between  chromium determinations  of  pooled  urine  samples  using CEWM-AA  and



chromium determinations using stable  isotope dilution methods measured by GC/MS.



The mean values for the respective methods  were 0.34 +0.1  and 0.32 + 0.02 pg/fc



(ppb).  Increases in urinary  chromium in  humans receiving a daily supplement of



200 pg Cr as CrCl- ranged from mean levels of 0.2 pg/fc (ppb)  prior to treatment to



1.02 and 1.13pg/& (ppb) after 2 and 3 months.  Although Anderson (1981)  cautions



against accepting absolute  values  for chromium from earlier studies, comparisons



and trends determined in  a given study may  be  valid.




     •Franchini et al. (1975)  and Borghetti et al. (1977) reporting about workers



exposed to  chromium  in  the   chromium-plating  industries  showed  that  urinary



excretion and renal  clearance  of diffusible chromium are biological  indices to



evaluate the  degree  of current exposure  and the  body  burden of the compound.
                                     3-38

-------
Franchini et  al.  (1978) confirmed  their earlier results  with  an experimental



investigation using rats.



     Other authors have demonstrated a close relationship between the amount of



Cr(VI) in the air and  urinary excretion  (Gylseth  et al., 1977) or urina'ry excre-



tion of the metal corrected for creatinine (Tola et al., 1977)*  Gylseth et al.



(1977)  reported in an abstract  that  welders  exposed to  a concentration  of



0.05 mg/m   (measured   as  chromium)  had  a  urinary  chromium concentration  of



-40 pg/fc,  measured  after  work.     Sjogren  et  al.   (1983)  showed  a  linear



relationship  between   worker exposure  to stainless   steel  welding fumes  and



urinary chromium levels.




     Krishna et al. (1976) studied 30 chrome workers who had nasal perforation.



The atmospheric concentration of  chrome  ranged  from  0.21  to 0.80 mg/m  .   Urine



samples from the workers were collected at the beginning of the day's shift and



again at  the  end of  the  day's  shift.   Before  exposure,  eight workers had  a



concentration of chrome in the urine of >0.20 pg/Jl (ppm), whereas after exposure,




20 workers had such values.   In an unexposed  control group, there was no change



in the urine chrome values.   While all the workers tested had nasal perforation,



66$ of them (20 of 30) had a urinary chrome concentration of >0.20 pg/mjl (ppm).



     Mutti et  al.  (1979) studied 22 welders who worked with high chromium alloyed



electrodes.   The concentration of the breathing zone levels of chromium,  deter-



mined during  the  1-month exposure  monitoring  period,  ranged  from 0.017  to



1.000 mg/m  for total  chromium, and from 0.002  to 0.350 mg/m   as hydrosoluble



chromium.   Urine samples from the  workers were collected at the beginning and  at



the end  of the experiment.  These results suggest that the urinary concentration



of chromium  at  the end of a  working period is affected by recent exposure to the



compound.   At  the same airborne  concentration,  the  greater chromium body  burden



is associated  with greater  excretion levels.   Even after a week  following the
                                     3-39

-------
last exposure,  urinary  chromium  levels  provide  useful indications  on  body



burden.



     Tandon et  al.  (1977) have  reported  urinary  excretion  of chromium  among



electroplaters and polishers  in an industrial setting.   A total of  12  subjects



were examined.  The range in  duration of exposure to chromium in electroplating



processes ranged from  2 to 20 years (mean duration for 12 workers = 11.1 years).



Chromium levels in workers' urine samples taken before starting work ranged from



91 to 1116  pg/Jl  (mean value =  326.5 pg/A (ppb)).  Urinary chromium levels did not



necessarily correlate  to duration of  exposure, but a slight trend was indicated.



Subjective complaints included coughing, breathing  difficulty,  dermal  itching,




depression, indigestion, body ache,  and edema of the lower limbs.   Mean urinary



chromium level in appropriate controls was  reported  to be 38.1 pg/£ (ppb) (range:




0 to 78 pg/&).   Subjective  complaints did not appear  to correlate  either with



urinary chromium levels or with duration of exposure.  Urine samples collected at



the  end of   the work  day,   however, would  perhaps  have   provided  a  better



correlation between exposure  and complaints of illness.








3.5.3.   Chromium in Human Hair.   Schroeder and  Nason  (1969) reported  a mean



chromium concentration  of 0.69 + 0.063 ppm  for women.   Hambidge  et al.  (1972)



measured chromium concentrations at various distances from the hair root.  They



reported that variation  in the concentrations  were  due to past fluctuations in



chromium nutritional  status.   Hambidge and  Rodgerson  (1969)  reported  higher



levels of chromium in the hair of nonpregnant women  (0.2 to 2.81 ppm) than in the



hair of pregnant women (0.04  to  1.11 ppm).   However, a later study by Hambidge



and Droegnueller  (1974)  found  changes in  hair  chromium levels due to pregnancy



not to be statistically significant.   Hambidge and Rodgerson  (1969) reported that



hair chromium levels in 3- to 8-month-old  infants were  significantly higher than
                                      3-40

-------
 in those of 2- to 3-year-old children.  Chromium is obtained  through breast milk



 during  nursing.   By  the  second year  of  life,  mean chromium  levels in  hair



 approached values present  in  older humans.








 3.6. SUMMARY








     Chromium  is a metallic  element  which, when  found  in nature,  is a stable



 mixture of four separate isotopes.  Inorganic chromium compounds occur in valence



 states ranging  from -2  to 4-6; however, in the environment the Cr(III)  and Cr(VI)



 states are the most stable.  Chemically, the Cr(III) state is  the  most stable and




 important form  of inorganic  chromium  complexes.  Cr(VI)  compounds comprise the



 most commercially important form of chromium, and they also appear to be the most



 significant chromium compounds from an environmental standpoint.   Because Cr(VI)



 is readily reduced in  the  presence  of organic material,  it  is rarely found in



 nature apart from deposition by anthropogenic sources.




     Although chromite ore is not currently mined in the United States, several



 chromium chemicals are  domestically produced  from  imported ores.  Sodium chro-



 mate, sodium dichromate, and chromic acid are three  of the more important commer-



 cial chromium  compounds produced  in the  United  States.    Metallurgical  uses



 constitute about 60% of  the largest market  demand  for  chromium.   Chemical  uses



are the second largest consumption  sector at 21$, followed  by refractory uses at



 18*.




     Chromium emissions are released into the air,  water, and land environments



 from a  variety  of industrial source categories including fossil fuel combustion,



cement  production,  incineration, cooling towers, refractory production, leather




tanneries,   steel  and  alloy  production,   electroplating,  and   chromite   ore



refining.   The  largest chromium emission sources  to the air are coal and oil
                                     3-11

-------
combustion,  chromium  chemicals production,  refractory  plants,  and  steel  and



alloy  plants.    Principal  sources  of  chromium  in  water  systems  include



electroplating  operations,   leather   tanneries,  and   textile   manufacturing



operations.   Significant  sources  of chromium-containing solid wastes'that  are



land disposed  include  chromite ore refining  operations and  chromium chemical



production plants.



     Recent monitoring of the air in many  urban  and  rural  areas of the country



has shown annual average chromium concentrations  to be in the range of 0.0052 to



0.1568 ng/nr; in remote parts of the world, concentrations as low as 0.005 ng/m^



have been reported.  The maximum concentration determined during any one 24-hour




measurement was about 0.6839 |ig/m  .   The chromium concentration in U.S.  waters



varies with the type of surrounding industrial  sources and the type of underlying



soils.  An  analysis  of 3834 tap waters in representative U.S.  cities showed a



chromium concentration  range of from 0.4 to  8 ppb.  Chromium levels in soils vary



with soil  origin  and the degree  of contamination from  anthropogenic chromium



sources.  Tests on domestic soils have shown chromium concentrations ranging from



1 to 1000 ppm, with the average concentration ranging from  14 to about 70 ppm.
                                     3-42

-------
                           4.  SAMPLING AND ANALYSIS








     Chromium occurs in trace  amounts  and  throughout the environment and is an




essential  micronutrient  for  man.    While  numerous  methods  have been  used to




measure chromium in various media, only recent methods have provided the accuracy




to measure  this  analytically troublesome element.   Moreover,  most  of the more




accurate methods measure elemental  chromium;  few provide usable information on




the oxidation states for trace amounts.




     The analysis of chromium in a certain medium usually involves three distinct




steps, namely, sampling and  storage,  sample  pretreatment, and  analysis.  These




steps, and the media to which they apply, are discussed below.








4.1. SAMPLING AND STORAGE








4.1.1.  Air.








     4.1.1.1.   AMBIENT AIR  — Dusts  and  fumes  of  chromium compounds  in  the




ambient air are usually collected by high volume sampler at a flow rate of about




20 to 30 nr hr~  (Demuynck et  al. ,  1976).   Typical filter media include cellu-




lose, polyethylene, polystyrene,  PVC, and glass-filter.  The suitability of the




filtering media primarily depends on their  background impurity level, particle




retention  efficiency,  and  tendency  to become clogged.   Dams  et al.   (1972)




evaluated different filter materials and concluded that polyethylene filters are




most suitable for the collection  of chromium particles in atmospheric air.




     When size fractionation is required,  multistage cascade impactors are  used




most often (Broekaert et al.,  1982;  Winchester et al.,  1981; Kowakzyk  et  al.,
                                      4-1

-------
1982).    At a  nominal  sampling rate  of  80 £ rnin" ,   chromium particles  of


aerodynamic diameter in the range of 0.04 to  25 pm  have  been separated by this


method  (Broekaert  et  al., 1982).   The  collection  surfaces  usually consist of


polycarbonate films, accompanied by Nucleopore backup filters (Kowakzyk et al.,


1982).  However, according to Jervis et  al.  (1983), Nucleopore filters contain


chromium impurities.  Chromium found in aerosols  from the  burning of coal, and


chromate from manufacturing plants,  occur as small particles, less than 2 urn and


less than 0.4 urn, respectively (Gary 1982).


     Although no specific information is  available,  it  is  reasonable to assume


that the filter paper  protected  from external  contamination can be stored for an


indefinite period prior to chromium analysis.





     4.1.1.2.   OCCUPATIONAL AIR —  Chromium in occupational  air  is  collected in


a way similar to ambient air.  A known volume of air  is drawn  through a poly vinyl


chloride  (PVC)  or cellulose  filter.     The   sampling  rate  is  maintained  at


1.5 H min"   (NIOSH,  1977).   However, it  has  been  determined by  Kneebone and


Freiser (1975) that although the PVC filter can be stored for at least 10 days,


cellulose filters cannot be stored for more than several hours without some loss


of Cr(VI).





     4.1.1.3.   STATIONARY SOURCE  —  The sampling  of chromium from stationary


sources, for example from the stack gasses of refuse  incineration  and fossil fuel


burning facilities, can  be done  by  collecting the sample isokinetically (Block


and Dams, 1976; Greenberg et al., 1978).  The  sampling train typically consists


of  a copper probe,  a rotameter, a manometer, and  a  pump  with  a capacity of

    •3   _i
20 nr hr  .  The diameter of the nozzle is adjusted  to the stack gas velocity to


achieve isokinetic sampling conditions  (Block and Dams,  1976).  Depending on gas
                                      4-2

-------
temperatures, glass-fiber, Teflon-fiber, and Whatman  41  filters have been used



(Block and Dams, 1976; Greenberg et al.,  1978).   However,  the use of glass-fiber



filters may result in a high blank value for chromium (Greenberg et al., 1978).



     For  studying  distribution  of particle size,  the isokinetic  sampling  is



typically   done   in   combination   with   a   multi-stage   cascade   impactor



(e.g., Andersen  cascade   impactor)  (Greenberg  et al.,  1978;  Block  and  Dams,



1976).  The different stages of the cascade  impactor can be used  to determine the



cutoff aerodynamic diameters of the collected particles.



     The same method used  for storing the filters  from  ambient air samples can be



used for the filters collected from the sampling of stationary sources.








4.1.2.  Water.








     4.1.2.1.   DRINKING  WATER  —  To  collect distributed  water  samples  from



household taps, the taps are typically run  to waste at their maximum flow rate



for 5 minutes to clear the  lines of overnight  standing water (Meranger et al.,



1981).  If suspended solids are suspected in the water, filtration is typically



done on location by passing  the  water  samples  through a  0.45 pm Millipore mem-



brane filter (Meranger et al., 1979).  In  order  to get representative samples,



some investigators (Greathouse and  Craun,  1978)  have  collected monthly samples



of finished water for a period of 1 year instead of one grab sample.  The water



samples are collected  in  clean linear polyethylene screw-cap collection bottles.



Concentrated nitric acid (1 mi/100 mJl water sample) is added to each bottle and



they are filled to  the brim to avoid any air  space.  The filled and capped bottles



are transported  in heavy  plastic coolers  containing gel-type  freezer  packs.



Immediately upon receipt  in the laboratory, samples should  be refrigerated at 4°C



(Meranger et al., 1981).
                                      4-3

-------
     Recently, a  novel method  for  preconcentration of  trace metals  in water



samples has  been proposed  by  Smits and  Grieken  (1981).    In  this method,  a



cylindrical  plexiglass  filtration   unit   consisting  of a  Nucleopore  0.4 pm



pore-size membrane  and a  2,2'-diaminodiethylamine  (DEN)-cellulose  filter  has



been used.  The Nucleopore  filter was used to separate the suspended particles in



water and the  DEN-cellulose  filter  allowed  straightforward  preconcentration of



trace cations by  a simple filtration step.  The collection efficiency for Cr(III)



by this method has been claimed to be 90-100$.








     4.1.2.2.   RAW AND SURFACE WATER  — The  sample collection,  preservation,



transportation, and  storage of raw and surface water samples are similar to those



for drinking water samples (Cranston and Murray, 1978;  Pankow et al., 1977).  A



more representative sample can  be obtained  by  collecting several  small samples



from different parts of the water body  than by collecting one large sample at a



single point because of the inhomogeneity of the water  body.








     4.1.2.3.   WASTEWATER — The sample  collection, preservation, transporta-



tion, and storage of  wastewater samples are similar to  those for  other water



samples.  Grab samples (Larochelle  and Johnson, 1978) are  often  collected  but



wherever  a  process  change is  suspected,  a  24-hour  composite sampling  is  the



preferred or even necessary method.








4.1.3.  Soil  and  Sediments.    Grab samples  are  typically  collected  for  the



analysis of chromium in soil and sediment.   In order  to evaluate  the  chromium



content in recent deposits, samples  are collected from the upper  few inches (2 to



3 inches) of sediment  or soil  (Pankow  et  al.,  1977).  The  samples  are usually



stored in polyethylene bags or bottles (Iwata et al.,  1981; Pankow et al., 1977).
                                      4-4

-------
The samples are  sieved  through nylon sieves (2 mm) to remove gravel and  leaves



(Iwata  et al.,  1981).    The  collected  samples  should  be stored  at  4°C or



refrigerated  during transportation  and storage  to minimize  bacterial  action



(U.S. EPA, 1979).








4.1.4.  Food.  No specific information for sample collection and storage of  food



samples could  be found in the  literature.   It is reasonable to  assume  that  grab



samples collected in polyethylene bags or bottles and refrigerated during  trans-



portation and storage should  be an acceptable procedure for sample collection and



storage.








4.1.5.  Biological Samples.  Blood samples  are typically drawn  from donors  with



either vacutainers or disposable syringes and aluminum  needles.   Heparin is  used



as the  anticoagulant.   Plasma samples can  be  obtained by  centrifuging freshly



drawn heparinized whole blood.   They  can be transported at 4°C  in polyethylene



tubes and frozen to -20°C during storage.  Urine  should be  collected from  donors



in polyethylene  bottles,  acidified,  and  stored  at 4°C  (Davidson  and  Secrest,



1972).   Other solid tissue  samples  can be  collected  in  polyethylene bags and



transported at 4°C.  The tissue samples can be stored at -20°C.   Lin (1982) noted



sources of contamination can arise from steel needles used  for blood drawing and



from borosilicate glass containers which contain 1-10 pg/Cr/g glass.  Moreover,



in urine  determinations utilizing  atomic  absorption,  interferences  can arise



from absorption by NaCl or organic materials in the urine  (Ping  et al., 1983).








4.2.  SAMPLE PRETREATMENT








     Sample pretreatment is often required  as a  technique to release the metal



from  the  sample  matrix, and  for concentration  and separation  from  potential






                                      4-5

-------
interferences.  A few  of the typical pretreatment methods  have been discussed



below.   Generally,  the pretreatment of  samples is dictated  by the subsequent



method of analysis.








4.2.1.  Wet and Dry Ashing.  This pretreatment method is often used for chromium



analysis  in  air  particulate  matter,   biological samples,   foods,  soil,  and



sediment  samples  in  combination  with  atomic absorption,  atomic  emission,



spectrophotometric,   and  neutron  activation analysis.    In  wet digestion  or



extraction methods,  the  sample  is digested with an acid  or a mixture of acids



depending on the sample matrix.   The composition and efficiency of commonly used



methods are listed in Table 4-1.   Acid mixtures which have been used include both



HNO   and  H2S04  (NIOSH,   1977),  HNO /HP  (Pankow et  al.,   1977),  HjSO^/H^



(Kumpulainen  et al.,  1979), HNCyH^  (Abu-Samra et  al.,  1975),  HCIO^/H^



(Davidson   and  Secrest,   1972),  HNO^HCIO^   (Gallorini   et  al.,   1976),



HNO-XH^Ojj/HClOjj  (Kuennen  et al.,  1982;  Feldman et al.,  1967)  and HNC^/H^O^



(Bryson  and  Goodall,  1981).  The two  commonly  used  dry  ashing procedures are



graphite  furnace  ashing   (Meranger  et al.,   1979;   Slavin,   1981)  and  low-



temperature oxygen plasma ashing (Kumpulainen et al., 1979).  Some investigators



also  have used a  combination of dry  and  wet  ashing  for  the  pretreatment of



samples  (Kumpulainen et  al.,  1979).  Whichever  procedure is used, a particular



ashing method  is  always  optimized to minimize  matrix interference and maximize



the chromium yield from  the sample.








4.2.2.   Precipitation.   The direct precipitation of chromium from aqueous solu-



tion  by such  reagents as  hydroxyquinoline  and tannic  acid is  generally not



suitable for   environmental  samples  containing  low  chromium concentration.




However, the method of  co-precipitation of chromium has  been successfully  used in
                                       4-6

-------
                                                       TABLE  4-1




                                Composition and Efficiency of AA Extractant Solutions*

Efficiency13
58.7
66.6
62.7
67.9
65.8
60.9
93.7
76.1

Nitric
50 (2m)
50

25
24
30
15
Type and Volume (mi) of Acid Mixtures
Hydrochloric Sulfuric Perchloric
d
50 (2 m)d

50
25
24 4
10 10
6 30

References
Day et al. (1975)
Day et al. (1975)
Agemian and Chau (1976a)
Agemian and Chau (1976a)
Chiu and Hilborn (1979)
Chiu and Hilborn (1979)
Chiu and Hilborn (1979)
Agemian and Chau (1976b)
 Adapted  from Tinsley  et al.  (1983)



 pg  of chromium extracted/g of dust sample
'Acids  are  concentrated
 Molarity  of solution

-------
recent years.   In  this method,  Cr(III)  is  co-precipitated  with Fe(III)  as



hydroxide at a pH of 8-8.5  (Cranston  and Murray,  1978; Pik et al., 1981).  The



co-precipitation of Cr(VI) has been accomplished by reducing Cr(VI) to Cr(III) by



the addition of Fe(II)  and subsequent co-precipitation of hydroxides of Cr(III)



with Fe(II)  at pH 8 (Cranston and Murray,  1978),  or by co-precipitating Cr(VI) by



Co(II) and  ammonium pyrrolidinedithiocarbamate  (APDC)  addition  (Pik  et al.,



1981).  The co-precipitated chromium is filtered from the solution and analyzed



by x-ray fluorescence or by flameless atomic absorption spectrometry.








1.2.3.  Solvent Extraction.  In this procedure,  Cr(VI)  is complexed with APDC at




a pH of 1.8-3.0  and  extracted with an organic solvent, typically methyl isobutyl



ketone (MIBK).   If Cr(III)  is  to be  extracted,  it must  first  be oxidized to



Cr(VI) with reagents such as silver nitrate and potassium peroxydisulfate or with



potassium permanganate  and  sodium  azide  (Towill  et al., 1978).   In  the gas



chromatographic  procedure,  chromium  is  chelated  with  1,1,l-trifluoro-2,4-



pentanedione or trifluoracetylacetone  (HFTA) and  the  chelate is extracted into



benzene.  This method has been used by a number of investigators  (Lovett and Lee,



1976; Gosink, 1976).







M.2.4.  Chromatographic Method.  A number of chromatographic materials including



alumina, cation-exchange resin,  anion-exchange resin, and chelating ion-exchange



resin have been used for the cleanup of impurities from chromium samples.  In the




anion-exchange  procedure,  the  solution  containing Cr(VI) is  allowed  to  pass



through the resin bed at an optimum pH.  The Cr(VI)  retained on the resin bed is



subsequently extracted  with a  suitable  eluent.   The major  drawback  of  this



procedure is that the recovery  of Cr(VI) is often poor.  . The problem, however,



has been alleviated by using an  ascending flow technique or by in situ reduction
                                      14-8

-------
of Cr(VI) by Fe(II)  (Pankow  and  Janauer,  1974).  Marino  and Ingle (1981) used



medium strength anion-exchange resin to obtain a satisfactory recovery of Cr(VI)




from the resin bed.



     In the cation exchange procedure, the resin is used  to  retain the' cationic



impurities while anionic Cr(VI) passed through the resin bed.   This procedure has



been used by Kneebone and Freiser (1975) for the analysis of Cr in occupational




samples.



     The chelatory ion-exchange  procedure  was employed by Leyden et al. (1972)




to absorb quantitatively Cr(III)  from  a buffered solution.   By this procedure,



Cr(VI) was detected by reducing it to Cr(III)  with the  addition of sodium bisul-




fite.



     The alumina procedure has been used for the separation  of both Cr(III) and



Cr(VI).  Larochelle and  Johnson (1978) adsorbed Cr(VI) on alumina column and used



HC1 for the subsequent elution of Cr(VI).  Wolf et al.  (1972), on the other hand,



used an alumina column for the separation of Cr(III).  In this procedure, Cr(III)



is precipitated with other cations by the addition of excess  8-hydroxyquinoline.



The dried precipitate is dissolved in chloroform, diluted with an equal volume of



benzene, and passed  through  an activated alumina column.   Chromium was eluted



with a mixture of chloroform and benzene.








4.3. METHODS OF ANALYSIS








     Chromium  can  be determined  by a  variety of analytical methods.   A  few



analytical methods used for the determination of Cr are given in Table 4-2.   It



should be emphasized that the detection limit and the percent-relative standard



deviation (% coefficient of variation)  values given in  Table  4-2 should be taken



as  values   representative  of   the   specific  pretreatment  techniques   and
                                      4-9

-------
                                                                        TABLE 4-2

                                                   Analytical Methods for the Determination of Chromium
Method Type of Sample
Graphite furnace AA blood, urine, and other
biologic samples9
natural waters
raw, treated, and dis-
tributed water0
-tr
1
_*
O
Flame AA raw, treated, and dis-
tributed water

natural water
blood, urine, and other
biologic samples
Spectrophotometric tissue samples
Preconcentration
none
co-precipitation
with Fe(OH)-
none
APDC-MIBK
extraction
APDC-MIBK
extraction

anlon exchange
MIBK extraction
APDC-MIBK
extraction
Selectivity
total Cr
Cr(III); Cr(VI)
can be reduced
to Cr(III) by
Pe(II)
total Cr
Cr(VI); Cr(III)
can be oxidized
to Cr(VI)
Cr(VI); Cr(III)
can be oxidized
to Cr(VI)
Cr(VI)
Cr(VI)
Cr(VI); Cr(III)
can be oxidized
to Cr(VI)
Detection
Limit
0.1 pg/8.
0.001 (jg/fc
2 PS/*
0.6 pg/i
0.05 pg/4

0.1 pg/l
10 pg/t,
1.2 pg/l
% cv
(at sample
concentration)
5.2%
(10 pg/l)
5%
(0.14 pg/l)
15> (2 pg/l)
20% (2 pg/l)
5% (3 pg/l)

20| (0.1 pg/l)
15* (25 pg/l)
0.4f (800 pg/l)
Interference

Matrix interference
can be avoided by
«et ashing.
none reported
none reported
none reported
none reported

none reported
none reported
Fe, Ni and PO.
may interfere







3-
Catalytic method
air participates8
Neutron activation       air particulates


                         freshwater^
                                                      .none
                              none
                                                      none
Cr(VI)
                                                   total  Cr
                                                                            total  Cr
1 ng



30 ng/n


0.12 pg/l
6% (<100 (ig/t)  Pb, Cu, Cr(III),
                Fe(III), and V(V)
                nay interfere
                                      151
                                                                                                   none  reported
                                                                                    (1.3  ng/m)

                                                                                    21 % (1.4 pg/l)  none  reported

-------
                                                                    TABLE H-2 (cont.)

                                                  Analytical Methods for the Determination of Chromium
Method
Gas chroma tography
(electron capture
detection)
Gas chroma tography
(AAS detection)
Gas chromatography
(MS detection)
Liquid chromatography
Type of Sample
natural waters
blood, serum, orchard
leaves
blood"
natural water"
Preconcentration
HTFA-benzene
extraction
HTFA-benzene
extraction
HTFA-benzene
extraction
1 I sample concen-
Selectivity
Cr(III) and Cr(VI)
Cr(III)
Cr(III)
Cr(VI)
Detection
Limit
0.1 pg/t
<1 ng
0.5 pg
0.8 pg/t
% CV
(at sample
concentration)
2.6| (1.9 pg/t)
<6> (1 ng)
9* (10 ng/g)
<2J (90 pg/t)
Interference
none reported
none reported
none reported
so'2, pofl3"
(coulometric detection)

X-ray fluorescence
(energy dispersive)
X-ray fluorescence
(energy dispersive)
Differential pulse
polarography
Emission spectroscopy
(inductively coupled
plasma source)

Mass spectrometry
dried solution deposit
surface water and drinking
water'
natural waters
                         natural waters
variety of samples
                              trated to 10 mt
none
chelating ion-
exchange membrane
                              none
                              none
                              none
                     total Cr
Cr(III)
                     Cr(VI)
                                                   total Cr
                     total Cr
                   1.5 pg/gp
0.8 pg/t
                   10 pg/l
                                        1.8-6
                   0.05-1 pg
                                                                                    (1 pg/cm )
10-15*
(1  jig/i)
may inerfere

absorption by
matrix and dif-
ference in
particle size
may cause error

excess alkali and
alkaline earth
metals may inter-
fere
              34) (61 pg/£)   excess Cu(II) and
                              Fe(III) may inter-
                              fere

              =5J             none reported
              20) (photo-     Any species having
              graphic)        the same m/e ratio
              3J (electrical) as Cr nuclide may
              0.5? (isotope   interfere
              dilution)

-------
                                                                    TABLE 4-2 (cont.)
                                                  Analytical Methods for the Determination of Chromium
Method
Chemiluminescence

Chemiluminescence
(lophlne)
PIXE (Particle
Induced X-ray
Emission)
% CV
Detection (at sample
Type of Sample Preconcentratlon Selectivity Limit concentration) Interference
natural waters and orchard none Cr(III) 0.02 pg/l 20* (at 2.3 Fe(III), Fe(II),
leaves" PPIB) Co(II), S032-.
and HO," may
Interfere
natural waters' ion exchange resin Cr(VI) 0.015 pg/fc Fe(III), Fe(II),
Co(II), Cr(IIJ),
MnOj.~, and
other cations and
anions may interfer
ambient airy; none total Cr <1 ng <35J inadequate sample
biological samples2 preparation; Pe may
interfere
aDavidson and Secrest, 1972
 Cranston and Murray, 1978
°Meranger et al., 1981   q
d
                         VanGrieken et al.,
e
Pankow and Janauer, 1971
Feldman et al., 1967
 Bryson and Goodall, 1981
8Kneebone and Freiser, 1975
hDemuynck et al., 1976
1Bhagat et al., 1971
JSalbu et al., 1975
kLovett and Lee, 1976
^olf, 1976
"Wolf et al., 1972
nLarochelle and Johnson, 1978
   Camp et  al.,  1975
  pKuhn,  1973
1977
  rCrosnun  and Mueller,  1975
  sQuinby-Hunt,  1978
   Boumanns and  deBoer,  1972
  uAhearn,  1972
  vElser,  1976
  *Hoyt and Ingle,  1976
  xMarino and Ingle,  1981
  yMetternich et al.,  1981
  zBartsoh  et al.,  1982

-------
instrumental methods  used  rather than  definite data.   For example,  both the

detection limit and percent CV  values  obtained by the same instrumental method

may vary several-fold depending on the extent of preconcentration of the sample
                                                                      >
and the method used for  eliminating  interferences.   These values may also vary

considerably from laboratory to laboratory and even within the same laboratory.

Part of the errors in measurement  occur from the absence of low level standard

reference materials.   Several  methods  for analyzing  chromium are  described

briefly below.




1.3.1.  Atomic Absorption  Spectrometry  (flame).  This method  has  been used by

various  investigators for  the  determination  of Cr  in  surface water,  sewage

effluent, and biological samples.  The determination of Cr by the air-acetylene

flame is prone to interference by other elements (Thompson and Wagstaff, 1979).

This  problem  can be  avoided  by using  nitrous oxide-acetylene  flame  but  this

results in  a  decrease in  the  detection  limit (Thompson and  Wagstaff,  1979).

Therefore, most investigators have used air-acetylene flame for the determina-

tion of Cr.  However,  for samples with low Cr concentration, pretreatment of the

samples providing preconcentration of  Cr and  the reduction  of the interfering

effects from  other  ions are required.   Thompson and  Wagstaff  (1979)  used an

evaporative technique on a hot plate  to concentrate the sample 5-fold.   A 2%

ammonium perchlorate solution  (W/V) was  used to suppress the interelement inter-

ference  effects.     Better  methods   for   pretreatment   of  samples  include

ion-exchange separation  (Pankow et al.,  1977;  Pankow and  Janauer,  1971),  APDC-

MIBK extraction  (Gilbert and  Clay,  1973) and  MIBK  extraction  (Feldman et al.f

1967).-  The  flame AAS  technique  is not a preferable method for samples with very

low Cr  concentration  since this method has  a  much  higher detection limit than

flameless AAS (Slavin, 1981).
                                      1-13

-------
1.3.2.  Atomic  Absorption  Spectrometry   (flameless).    In  the  flameless  AAS



method, the sample is atomized  directly  in a graphite furnace,  carbon  rod,  or



tantalum filament instead of a flame.  It is one of the most attractive methods



for the analysis of solid and liquid biological samples since the method does not



generally require sample preparation.  Despite the high sensitivity of the flame



less AAS method,  it may suffer from certain disadvantages.  For example, matrix



interference, background  or nonspecific  absorption effects,  volatilization  of



some Cr during dry ashing, and adsorption of Cr on the walls of crucibles during



dry ashing can cause error  in analysis.   The matrix interference effect in the



case  of water samples  can  be  overcome   by  chelation  and solvent  extraction




(Meranger et al.,  1979,  1981) or by the co-precipitation technique (Cranston and



Murray, 1978), and in the case of biological samples, by wet disgestion (Davidson



and Secrest, 1972) prior to  introduction of the sample into the graphite furnace.



The Zeeman background correction systems  for non-specific absorbance are those



most recommended  for the analysis of Cr  (see handbooks on EAAS by Perkin-Elmer



and Hitachi).   Other background correction  systems include the  dueterium arc



corrector  (Cranston  and  Murray,   1978),   and,  by  continuum source,  echelle,




wavelength-modulated, atomic absorption spectrophotometer (CEWM-AA) (Kumpulanen



et al.,  1979; Veillon et al.,  1982a,b).   The volatilization of  Cr  during dry



ashing at temperatures of 700°C or higher, particularly  during  the analysis  of



complex matrices  such  as  food,  may be substantial  (Kumpulainen  et al., 1979).



Low temperature ashing,  for  example, with  oxygen  plasma at  150°C, would eliminate



this problem  and  the problem of Cr adsorption on crucible walls.  However, the



low temperature ashing may  not  be suitable for  some biological  samples (bovine



liver), and  some  biological materials such as  brewer's  yeast  may contain acid



insoluble material that can  strongly  adsorb chromium (Kumpulainen et al., 1979).



However, these problems have been  overcome by utilizing dry ashing at 500°C with

-------
sulfuric acid and hydrogen peroxide as ashing acids (Kumpulainen et al., 1979).



The problems of sorption and volatilization can also be eliminated by the use of



"platform" technique described by Slavin (1981).



     Versieck et al.  (1978)  reported  that  chromium levels in serum from normal



subjects was 0.16 pg/fc when determined by carefully conducted neutron activation



analysis.   In a  survey  of  previous  reports  of chromium  levels  determined by



flameless AAS, the range of values was 0.73  to  150 pg/fc, and the levels tended to



become  lower as  improvements in  detection  limits  occurred.   These  results




prompted an intensive  study of possible sources of artifacts in the flameless AAS



analysis of biological fluids by Kayne et al.  (1978) and Guthrie et al. (1978).




Guthrie et al. (1978), in  a  study of the effects of purge gas, char temperature,



sample  volume,  and  graphite  tubes  on the  determination  of low ppb  levels of



chromium, demonstrated that  all  these parameters affected the  background  non-



atomic  absorption, and that there was a direct correlation  between background



absorption and the apparent  chromium  content  of the sample.  It  was  suggested



that the background correction was inadequate  as the result of the low intensity



of the D- lamp at the near UV wavelength used in chromium analysis.  Kayne et al.



(1978) came to a  similar  conclusion,  and modified  the background  correction by



replacing the usual D_  lamp with a tungsten  halogen  lamp.   This  modification



provided adequate background correction,  and  serum chromium levels determined



for 8 normal male subjects averaged 0.14 pg/H,  while  most measurements from 66



randomly chosen urine samples were -0.9 pg/fc.   Guthrie et al. (1978), Kayne et



al. (1979), and Anderson  (1981) noted  that earlier reports of chromium levels in



urine and  serum  should be  considered artificially high  (by about  an order of



magnitude) in light of these findings.

-------
1.3.3.  Emission Spectroscopy.  In emission  spectroscopy,  prepared samples are

excited with a flame,  arc, spark, or plasma and the resulting light is dispersed

with a monochromator.   The characteristic emission lines of the excited elements

are recorded electronically or on a photographic plate.  Because  of its better

sensitivity, inductively compiled plasma atomic emission spectrometry (ICP-AES)

has been more extensively used in recent years than the other modes of excitation

(Towill et al., 1978; Slavin,  1981).   Since  the sample  is  generally introduced

into  the plasma source  by pneumatic  nebulization, all  solid and  biological

samples require wet digestion prior to  analysis.  The wet digestion also tends to

minimize the matrix effects.  A HF/HNCL  digestion at 170°C has been employed for

the simultaneous multi-element analysis of  air  particulate  matters (Broekaert

et al.,   1982).     Similarly,   wet   digestion  by  direct  chelation   with

1,1,1-trifluoro-2,4-pentaedione (also known as trifluoroacelytacetone) (HTFA) or

hexafluoroacetylacetone (HHFA) has been used for the cleanup and volatilization

of Cr in biological samples  (Black and  Browner,  1981) prior to ICP-AES analysis.

Recently, a  direct atomization technique for raw agricultural  crop samples has

been presented (Kuennen et al., 1982).  The technique employs a 30-minute pres-

sure dissolution of sample composite with 6M HC1 at 80°C in linear polyethylene

bottles.  The dissolved samples after proper  filtration  by Teflon  filters can be

aspirated directly  into  the  plasma source.   Combined  with  real  sample matrix

calibration technique, it has  been suggested  that this method provide comparable

recovery and  precision as obtained by  the  more time-consuming conventional wet

ashing methods.




H.3.4..  Neutron Activation Analysis.  Neutron activation analysis is one of the

most  sensitive modern analytical  techniques  for  the  determination of  trace
           f
elements.  Neutron activation analyses are applicable to many kinds of environ-
                                      4-16

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mental samples including air participates,  dusts,  soils,  fresh and marine water,

sediments,  biological  liquids and  solids, and  foods.   The samples  are often

irradiated without prior chemical treatment.  A detection limit of 0.12 pg/fc in

freshwater  (Salbu et al.,  1975) and  0.2 pg/g  in biologic materials (Spyrou

et al.,  1974)  has been  reported for samples  analyzed  without  chemical proces-

sing.   Lower  detection limits generally  can be  achieved  if the  samples are

chemically processed to separate and concentrate chromium.  For example, in the

chemical processing  of  samples typically by ion-exchange separation,  detection

limits of 0.1  ng/H for  river water,  3  ng/8, for seawater, in the  ppb  range for

biological  samples  and  the  ng/nr  range  for ambient  air  have  been reported

(McClendon,  1974;  Robertson and Carpenter, 1974;  Kowalczyk  et  al.,  1982;  Lin,

1983).

     One distinct advantage of this method is the  reduced problems arising from

reagent contamination.  Even  if  chemical processing is required,  post-irradia-

tion contamination is of no consequence in  introducing error to the final result.

In addition to the problem of acquiring a  neutron  source,  this method has another
                                                                          21
disadvantage.   Due to  the intense x-ray or  bremsstrahlung  activity from   Na,
oQ    ilO   C f\        ^2
  Cl,   K,   Mn, and   p in many samples, the  irradiated samples usually must be
                                                        t>
cooled for several weeks before measuring Cr concentration.  However, chemically

separating  the offending  nucleides can  reduce  the cooling  period   to  about

24 hours (McClendon,  1974).


4.3.5.  X-ray  Fluorescence.   The x-ray fluorescence method  is  commonly applied

to solid samples.  In this  technique,  the  sample is bombarded  with high energy

photons, for example, low energy  x-ray  or gamma photons or with particles such as

protons.  The intensity  of the characteristic emitted x-ray is currently measured

by two techniques, namely, energy-dispersive analysis and wavelength-dispersive
                                      4-17

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analysis.  The resolution of wavelength-dispersive analysis is much better than



energy-dispersive analysis  which  often permits the former method  to determine



the oxidation states of an element (Quinby-Hunt, 1978).



     This technique is useful for trace  analysis  in solid samples, namely, air



particulates  (collected  on filters),   sediments,  biological  specimens,  and



filtered suspended  solids from aqueous  media.   However, for  aqueous samples,



sample preparation leading to the deposition of the element on a filtering medium



is required.  This deposition can be done by a variety of methods.   The obvious




and simple method is the evaporative drying of the  sample  on a Mylar film (Tanaka



et al., 1981).  Other methods of sample deposition  include retention on chelating




filters  (Smits  and  Van Grieken,  1981), vapor  filtration technique (Greathouse



and Craun, 1978) and co-precipitation (Pik et al., 1981).  The last  three methods



not only allow deposition of Cr on a  filtering media, but also permit separation



and concentration of Cr from the aqueous phase during the deposition step.



     Sample preparation in the  case  of solid  samples is an important requirement



for this method.  In order to avoid absorption and scattering by sample matrix,



the size and shape of the particles on the films should be controlled by pressing



the deposits into thin wafers (Towill et al.,  1978).








4.3.6.  Colorimetric.   The diphenylcarbazide  colorimetric  method  is the most



commonly used for monitoring chromium compounds. Either through the oxidation of



Cr(III) or direct reaction with Cr(VI), this method  was proposed by NIOSH  (1976)



as a  "Draft—subject to  review"  procedure for measuring Cr(VI) in occupational



atmospheres.    While  it  is  sensitive to  10  and  50  pg  samples,  it  has poor



sensitivity for samples of 0.5 and 1 pg.  (Bhargava et al., 1983).  The  method may



not be suitable for use with welding fumes.  Instead, a carbonate leaching  method



has been described for  the determination of Cr in welding fumes  and  other complex
                                      4-18

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matrices (Thomsen and Stern, 1979).  Bryson and Goodall  (1981) have described a



modified diphenylcarbazide  spectrophometric  method for the determination of Cr



in biological tissues.








4.3-7.  Gas Chromatography.



     The gas chromatographic method  is  suitable for a variety of environmental



samples.  The analysis of water samples by this method  does not generally require



pretreatment before complexation (Lovett and Lee, 1976).  Samples  that are solid,



namely, particulate matter, and biological samples are first digested to get Cr



in solution.  The  Cr  is  then quantitatively chelated with 1,1,1-trifluoro-2,4-




pentanedione  (HFTA) or  hexafluoroacetylacetone  (HHFA)   to  form  a  thermally



stable, volatile Cr(III) complex.  To determine Cr(VI), it should be reduced to



Cr(III)  by a reducing  agent,  such  as  sodium sulfite.    The Cr(III)-HFTA  or



Cr(III)-HHFA complex is  extracted  into an organic  solvent,  usually  benzene or



hexane,  and  an  aliquot  is  injected  into the  GC  column.   Recently  a  direct



chelation  (without  pretreatment)  method has  been  described   for  biological



samples (Black and Browner, 1981).




     The detection of Cr(III) complex can be  accomplished by a variety of detec-



tors.   The sensitivity  of  this  method  is dependent  on  the  detector  used.   A



number  of  detectors  including  electron capture (Lovett and  Lee, 1976),  atomic



absorption  (Wolf,  1976),  mass spectrometric  (Wolf et al.f  1972), and ICP-AES



(Black and Browner, 1981) have been used.



     The gas  chromatography with  any of the detection  methods described  has



excellent sensitivity for Cr determination, but  the mass spectrometric method is



extraordinarily  sensitive and specific.








4.3.8.   Chemiluminescence.   Luminal (5-amino-2,3-dihydrophthalazine-1,4-dione)



and  lophine  (2,4,5-triphenylimidazole)  emit  light when  oxidized  by  hydrogen






                                      4-19

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peroxide.  The first  oxidation in basic solution is catalyzed by Cr(III) and the



second by Cr(VI).   The design of different chemiluminescence instruments for the



determination of Cr  vary primarily  in  the technique for mixing  the  sample and



reagents.  The three  types of sample modules which are commonly used are discrete



sampling system, flow system, and centrifugal  analyzer (Hoyt  and Ingle, 1976).



All these sample modules have been  used  for the analysis of Cr (Towill et al.,



1978).



     The chemiluminescence method  has been used primarily for the analysis of Cr



in water  and in biological samples  (Marino and  Ingle,  1981;  Hoyt  and Ingle,



1976).  The method is fast,  economical, and has a high sensitivity.  The sensi-




tivity can be further increased by  preconcentration  of the samples (Marino and



Ingle, 1981).  However, this method has  not been as widely used as some of the



other methods.








4.3.9.  Polarography.  Two recent  variations of the method, namely, single-sweep



polarography and differential pulse polarography, have both been  used for the



detection of Cr in natural waters  (Whitnack,  1975;  Crosmun and Mueller, 1975).



The  polarographic  method  has  a  comparatively  lower  sensitivity  than  other



methods and is not currently popular for Cr analysis.








4.3.10. Mass  Spectrometry.    The  spark-source  mass  spectrometric  method  is



applicable to  virtually any  matrix, but  the results are only semiquantitative




(Towill et al., 1978).  The precision and accuracy of this  method can be greatly



improved by using the isotope dilution technique.  This method has been used to



establish the  Cr  content  in NBS bovine  liver  (Dunstan and Garner, 1977).  The



mass  spectrometric  method  is  rarely  used  for  the  routine determination  of



chromium.
                                      4-20

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H.3.11. Catalytic Method.   This  method has been used  for the determination of


Cr(VI) in occupational samples  (Kneebone and Freiser, 1975).  In this method, the


microdetermination  of  Cr(VI)  is done by  means of Cr catalyzed  oxidation of


o-dianisidine by  hydrogen peroxide.   The  reaction rate  is  monitored1 spectro-


photometrically.   This  method has  limited application  (occupational samples)


because  of  interferences by  various  cations,  and  it is  rarely used  for the


determination of Cr.





H.3.12. Liquid  Chromatography.   This  method in  combination  with a coulometric


detection has been used  for  the determination of Cr  in water samples (Larochelle


and Johnson, 1978).  In this method  Cr(VI)  is  separated by an alumina column and


the separated solution  is passed through a flow-through  coulometric detector.


Although the method has  been purported to have good  sensitivity and precision, it


has found little application in the analysis of chromium.





H.3.13. Particle Induced X-ray Emission.  Particle Induced X-ray  Emission (PIXE)


has been used to analyze elemental constituents  of particulate matter.  PIXE was


first  introduced  by Johansson and  Johansson  (1970) and has  found  wide use in


elemental  analysis  of  atmospheric  aerosols  and   considerably  less  use  for


biological samples.  In  this method, atoms  of  interest are bombarded by protons.


The incident particles will interact with the atoms to eject electrons, thereby


ionizing the atoms.  The  characteristic  X-rays  emitted  are proportional to the

                2
atomic number (Z ).  PIXE analysis of elemental Cr  is sensitive  to the nanograra


level; it is a rapid, multielemental, nondestructive technique which requires no


chemical breakdown  of  the sample.  However,  elaborate sample  preparation and


highly  skilled  operators are  required  for successful analyses  (Metternich et


al., 1982; Bartsch et al., 1982).
                                      4-21

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J4.M. CONSIDERATIONS IN ANALYSIS








     The determination of Cr in samples containing trace amounts of the compound



requires special precautionary measures from the initial sample collection step



to the final analytical manipulations of the samples (Zief and Mitchell, 1976).



For example, contamination of samples during collection should be avoided by the



use  of  Cr-free equipment.   This  is  particularly true  for the  collection  of



biological samples with stainless  steel needles,  scalpels,  trays  and  utensils



which may contain  18?  chromium.  Similarly, sample containers should be free from



the  possibility of sample  contamination.   Polyethylene  bottles  and bags  are



particularly suitable  as sample containers.   Even with  polyethylene  bottles,



adsorption of  Cr  on  the surface of the container  from water samples may be  a



serious problem.  Therefore,  acidification of aqueous samples prior to storage is



necessary to avoid adsorption losses.



     The possibility of sample contamination  and  losses  during analytical pre-




treatment of the  samples should be  avoided.   Care  should  be taken that  only



reagents of the highest purity are used.   Even so, the quantity added should be



limited to a minimum to avoid unnecessary buildup of  contaminants.   The use of



Cr-containing grinding or homogenizing equipment can introduce Cr-contamination



into the samples.   Grinding  such samples  with an agate mortar and pestle  is  a



better  procedure.   The  analysis  of Cr,  especially in biological samples,  is



complicated by  extreme matrix effects, possible volatility of some Cr complexes,



and  the inherent  property  of Cr-complexes  to  bind non-specifically  to  reaction



vessels, graphite  tubes, or other equipment.   The methods used to minimize these



problems have been discussed in section 4.3.2.



     The problem  of developing accurate data  from Cr analysis, particularly in



food and biological samples, is amply illustrated  by the large variations in the
                                      4-22

-------
interlaboratory  comparison  data  (Towill et al.,  1978).  The problem is  further



aggravated by the non-availability of Standard Reference Materials  (SRM).  Only



recently has the National  Bureau of Standards (NBS) issued materials certified



for  Cr,  such as brewer's  yeast  (SRM-1569),  bovine liver  (SRM-1577),   orchard



leaves  (SRM-157D,  spinach leaves  (SRM-1570),  pine  needles  (SRM-1575),  and



tomato leaves  (SRM-1573).   In view  of  the absence of suitable comparison with



SRMs, the older  data should be interpreted with skepticism.



     Another problem in dealing with the analytical methods is their ability to



distinguish between Cr(III) and  Cr(VI).   This  is  particularly important since



Cr(VI) has been associated with health hazards, while Cr(III)  is of substantially




less concern and is  in  fact necessary  (at very  low  but as  yet  undetermined



levels) for  the maintenance of  a normal glucose  tolerance  factor (Marino and



Ingle, 1981).  The problem  for the determination of the two oxidation states of



Cr is not  critical  in  foods, sediments, soils, and biological  samples, because Cr



is genrally present in the  Cr(III) state in these  samples.   However,  Cr may be



present in both  oxidation  states  in  ambient and occupational air,  and in water



samples.   It should also be recognized that Cr(VI) may be present in both water



soluble and water  insoluble  form  in  these  samples.    It  is  necessary  to



distinguish these two forms of  Cr(VI),  as they  may have different  genotoxic



properties  (Thomsen and  Stern,  1979).   Some  of the methods  that  distinguish



between Cr(VI)  and Cr(III)  have already  been  discussed.   The analytical method



for the determination of soluble  and  insoluble  forms of Cr(VI) in  occupational



air samples has been described by Thomsen and Stern (1979).
                                     1-23

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-------
                  5.  CHROMIUM METABOLISM  IN MAN  AND  ANIMALS








5.1.  ROUTES OF CHROMIUM ABSORPTION








5.1.1.  Chromium Absorption and Deposition  by Inhalation.  An important route of




exposure to  chromium compounds  is through inhalation  of  chromium  containing




aerosols.   In  general,  during  inhalation (and  exhalation)  a portion  of the




inhaled  aerosol  may be  deposited  by  contact  with  airway  surfaces  or  be




transferred to unexhaled air.  The  remainder is exhaled.  The portion transferred




to unexhaled air may be either deposited by  contact with  airway surfaces or later




exhaled.  These phenomena are  complicated by interactions that may occur between




the particles, other gases and the  water  vapor present in the airways (U.S. EPA,




1982).   As such,  the deposition and retention patterns  for  chromium aerosols




depend on the size and solubility of the particular chromium compound.




     Chromium aerosols occur  mainly  in  the small  particle-size fractions.  The




oxidation state of the Cr compound depends on the emission process as well as the




atmospheric  interactions.   In  metallurgy, most  of  the  chromium released  is




elemental or trivalent (NAS, 1971*).  In the  chemical industry, chromate dust from



the processing  of chromite ore  averaged 0.32 to  0.37 pm in diameter (Gafafer,




1953).  Fly ash from coal-fired electric  power plants contained Cr in the 1-2 pm




size  fractions  (Davidson et  al.,  1974).  Combustion processes  under alkaline




conditions  are  conducive  to  the  formation  of Cr(VI).   The distribution  of




chromium in  the  human  lung  was investigated  by Bartsch  et  al.  (1982),  who




examined 35 lung pairs obtained during autopsy  from randomly selected patients in




Liege, Belgium, an area containing many steel  plants and foundries.  Using PIXE
                                      5-1

-------
analysis (Particle Induced X-ray  Emission), they found that Cr concentrations in



the lung averaged 2.85 pg/g (ppm) dry matter, with the largest amounts occurring



in the  lymph  nodes.    The remaining chromium was  distributed  over  a  gradient



toward  the  apexes of  the  lungs,  suggesting  to the  authors  a relation  to  the



normal distribution of inspired air and contaminants during normal breathing.



     Langard et al. (1978) exposed rats to zinc chromate(VI) dust at a concen-



tration of 7.35 mg/m  .  Before exposure,  the mean  blood  chromium concentration



was  0.007 pg/m£  (ppm).    Following exposure,  values  were  0.024,  0.22,  and



0.31  pg/mfc (ppm) at 100, 250, and 350 minutes,  respectively.



     The next portion of the study involved four consecutive daily exposures of




6 hours duration to zinc chromate at a level of 7.35 mg/m  .  Blood concentrations



appeared to peak after the second exposure session.  Mean blood chromium values



from samples taken immediately after each exposure session were:   0.30, 0.56,



0.46, and 0.34 pg/m& (ppm) for days 1  through 4.   The mean blood chromium level



following 2  months of  exposure  for 6.5 hours/day, 5 days/week was quite similar,



0.495 pg/mB, (ppm).   There were  no significant differences  in  absorption,  as



reflected by blood chromium  level,  between the  sexes or between  day and night



exposure regimens.  Kamiya et  al.  (1981) exposed  rats to  chromite  dust  for 28



days  to determine  distribution  and  retention  of  total Cr  from  inhalation



exposure.  While data are limited,  qualitative  conclusions can  be drawn.   Whole



blood total  Cr levels measured at various times throughout the exposures remained



about the same from days 5 through  28.  The highest Cr concentrations were found



in the kidney  followed in  decreasing order by the lung, spleen,  liver and  blood.



Concentrations in the liver were similar to those  in the blood, changing little



from days 5 to 28.  Levels in the lung, kidney  and spleen were  cumulative.



     Baetjer et al. (1959a) exposed  guinea pigs via intratracheal administration



to 200 pg chromium as sodium chromate(Vl), potassium dichromate(VI), or chromic
                                      5-2

-------
chloride(III), all of which are water soluble salts.  For the Cr(VI) compounds 10



minutes post-instillation, 15$ of the dose remained in the lungs, 20% was found



in the blood, and 5% was distributed among  various  soft  tissues.  Clearance of



chromium upward from the trachea and  subsequent  swallowing  is assumed to account



for the majority  of the dose not found in the blood and  tissues.  During the first



24 hours, =13$ of the dose was excreted, 11$ remained in the lungs, and 16$ was



found in the blood and other tissues.  After 140 days, chromium had been essen-



tially  cleared  from  all  tissues  except  lung  and  spleen.    For  chromic



chloride(III)  10 minutes post-instillation, 69$  of the administered  dose  was



retained in the  lungs, with 4$ in the blood  and  other  tissues combined.  Twenty-




four hours post-exposure, the lungs retained 45$ of the administered dose; lung



retention after  30 and 60 days was 30 and 12$, respectively.



     Of the water  soluble  salts studied,  Cr(III) is  absorbed  much more slowly



from the  lungs  than Cr(VI),  possibly  as a  result  of binding  to extracellular



macromolecules.   In  addition,  analyses of  lungs  from experimental animals and



human autopsy specimens indicate that water soluble salts undergo conversion to



very insoluble moieties with long residence times in lung tissue (Baetjer et al.,




1959a).



     Wada et  al.  (1983)  exposed male SD strain rats to CrCl3 at an atmospheric



concentration of 14.1 mg/m  (Cr), and observed that the chromium was associated



with both high and low molecular weight  proteins.  The chromium which remained in



the  lungs was  associated with  the  high  molecular  weight  fraction  and this



fraction  slowly  decreased  with time  following exposure.   The level of chromium



associated with  the  low molecular weight fraction  remained  constant  for the 5



observation  days following treatment;  however, chromium  associated  with this



fraction accumulated with time in the liver. The authors suggested that the low



molecular weight protein was involved in the absorption and transport of chromium
                                      5-3

-------
I ;


           following  inhalation.    Low molecular  proteinuria was  also noted  in rabbits



           MM«iving subcutaneous injection of  1.77  mg Cr(VI)/kg body weight (Nomiyama et



           ml., 1982).



                Visek  et  al.  (1953) also  studied the  fate  of  51CrCl,  following intrat-



           raoheal instillation. Seven days post-exposure, 55% of the chromium was excreted



           IB the feces and 7% in the urine.   These data agree with Baetjer et al. (1959a),



           in that a large portion of the administered dose appears to have been cleared to



           tfee gastrointestinal tract.  Tissue concentrations in this study indicated that



           «55( of the administered dose was absorbed from the lungs.



                No data  are available which  could  be  used  to  accurately  estimate  total



           pulmonary absorption following inhalation  exposure.  The contribution of gastro-



           intestinal absorption to  body burden  following  inhalation or intratracheal expo-



           sure is not clear.







           5.1.2.   Gastrointestinal  Absorption of  Chromium.  Gastrointestinal absorption of



           chromium also appears to  be dependent on valence state.  Donaldson and Barreras



           (1966)  examined  absorption  of   CrCl-(III)  and Na   CrOu(VI)  in rats and  in
                                                3            fc     *T


           humans   and  conducted  a   series of  in vitro  evaluations  to  clarify  factors



           affecting absorption.



                Based  on  fecal  excretion,  mean  absorption  of  orally  administered  ^1Cr



           compounds  in  human  patients  was  =0.4$  for  CrCl-   and  =10.6$  for  NapCrOj..



           Approximately 0.5 and 2.1$ of the doses  of CrCl-, respectively, were excreted in



           the  urine  after  24  hours.    When  CrCl,  was  administered  intraduodenally,



           absorption  of  CrCl-  was  not   appreciably   increased;  however,  intraduodenal



           administration  of NaCrCv  resulted in  an estimated  50$  absorption.



                In rats,  »2$ of the  intragastric dose of both CrCl, and Na CrOj. appeared to



           be absorbed  based on fecal excretion (i.e., it was assumed that any radioactivity
                                                 5-4

-------
not recovered in the feces represented the absorbed portion of the dose, although



it  should  be noted that  the percision of these  estimates  may be questioned).




Jejunal administration increased apparent CrClo absorption to B%, while Na2CrOjj



was increased  to =25$.   Similar low  levels  of absorption  of less than 1$ were



estimated by determining whole body counts 2  days  after administration of radio-




labeled CrCl_ or Na^rOj, (Sayoto et al.,  1980).



     In vitro studies by Donaldson and  Barreras (1966)  showed  that CrCl, (III)



was bound  by both neutralized  and acid gastric  juice,  while  NapCrOj.  (VI)  was



bound by  acid gastric juice  alone.  Binding  effectively prevented  uptake by



intestinal sections.  Acid  gastric juice,  in addition to binding Na CrOj. (VI),



also was capable of reducing Cr(VI) compound to Cr(III).



     These absorption  values must  be considered rough  estimates.   Short-term



urinary excretion values cannot take into account either deposition of chromium



into body sinks or the potential contribution of intestinal excretion.  Absorp-



tion estimates by difference from  fecal excretion also cannot take into account



the potential role of enterohepatic cycling.



     MacKenzie et al. (1958) administered either K2Cr04  (VI) or  CrCl3 (III) in



the drinking water to rats at 25 mg/S, (ppm).  After 1 year of exposure, animals



receiving the hexavalent compound  had average tissue levels that  were 9 times



higher than those receiving the trivalent  salt.  This was  interpreted to indicate



much greater gastrointestinal absorption  of  the hexavalent  salt.   The possible



role of differences in elimination kinetics was not addressed.



     Mertz et al.  (1965) administered  a  single  dose of 0.15,  1.0,  or 10 pg



  CrCl,/g body weight by stomach tube to  rats.  By comparing whole body radio-



activity 4 to 10 days after an  intragastric  dose  with that  following an intra-



venous  dose,  they suggest  2  to  3%  as  a rough  estimate of  gastrointestinal



absorption.   Absorption  was found  to be  independent  of dose  level  or dietary
                                      5-5

-------
chromium  history  (deficient  versus supplemented).    (Doisy   (1971)  estimated



absorption at 0.5$.



     Visek et al. (1953)  gave a single dose of CrCl,  (III) by gavage to rats.



Tissue distribution  indicated <0.5% absorption after 4 days.   Urinary excretion



suggested higher  absorption  estimates,  but fecal contamination  of the samples



was suspected.



     MacKenzie  et al.  (1959)  administered  Na^rO^  (VI)  as  a single  dose  by



stomach tube.  Urinary excretion of 6$ of the dose after 14 days in fasted rats



and 3%  in  non-fasted  rats was observed and used  as  an estimate of absorption.
Blood chromium concentrations  when  rats were given Na^CrO^  were  2-fold higher


                       51
than for animals  given  CrCl,.  This is not surprising,  since Cr(III) is cleared



from the serum much more rapidly  than  Cr(VI)  disappears from the erythrocytes.



Urinary excretion data for Cr(III) compound were not reported.



     Additional evidence for the poor absorption of CrCl_ (III) was presented by



Mertz et al. (1965).  They found that a 100-fold greater oral dose was required



to alter glucose tolerance in rats than the intravenous effective dose.



     Ogawa (1976) examined differences in absorption and metabolism via several



routes of exposure using CrCl (III)  and Na CrO (VI) administered to rats.  They



found gastrointestinal absorption to be 2.4 and 1.4$, respectively, for the two



salts.   When animals were  fasted for 48 hours, absorption  of both  salts was



increased to 11$.



     Although  precise quantitation  of  absorption  efficiency  is  impossible,  a




reasonable estimate from the available  literature  discussed  above is that both



valence states are absorbed at efficiences of <5$.








5.1.3.    Chromium  Absorption  Through  the Skin.   Percutaneous  absorption of



chromium appears to be  related  to valence state,  the particular salt employed,



and the concentration applied.






                                      5-6

-------
     Mali (1963) conducted a series of in vitro and in vivo studies to determine


penetration of  potassium  dichromate(VI)  and  chromic sulfate(III)  through  the


skin (the source of skin  was  not  mentioned).   They found that neither compound


diffused  spontaneously through  intact,  isolated epidermal  membranes.    The


diffusion  constant  for  diffusion  of  the   Cr(VI)  compounds  through  dermis


(314 x 10~6 cm2/min)  indicated unimpeded absorption;  however,   the  diffusion

                                                  ft   ")
constant for the trivalent compound was 26.6 x 10~  cm /min.


     Significant amounts (30$) of Cr(III) were bound to dermal proteins in vitro,


while only  very small amounts  (1$)  of Cr(VI) were bound  (Mali,  1963).   These


results were confirmed in  human volunteers.  It was found that in vivo potassium


dichromate but  not  chromic sulfate penetrated intact epidermis.   In addition,


reduction of Cr(VI) to Cr(III) in  the  skin tissue was demonstrated.  The rate of


this reduction was pH dependent.


     Samitz and Katz  (1963, 1964)  presented additional data which indicate that


Cr(III) binds to skin in  vitro,  and that binding  following  exposure to Cr(VI)


salts is dependent upon reduction to Cr(III).


     Samitz and  Gross (1961)  presented  preliminary  evidence that  there  is no


difference  in  absorption  of  potassium dichromate(VI)  as  compared  to chromium


nitrate(III) in vivo  in guinea pigs.   Samitz  and Shrager (1966)  reported addi-


tional evidence that permeability of the skin  to  Cr(III)  is dependent upon which


salt is  employed.   Their  data  indicate  that  absorption of  chromic sulfate is


negligible,  absorption of chromium nitrate  is  somewhat greater than chromic


sulfate absorption, and absorption of chromic chloride is as great as potassium


dichromate.   Waklberg (1968)  noted  that  percutaneous  absorption  of sodium


chromate was greater  at pH 6.5 and higher compared with pH 5.6 and  lower.


     Wahlberg (1965)  reported  that absorption of a given salt is  dependent upon


the  concentration  applied.   In this  study,  application of  0.017 M to 0.239 M
                                      5-7

-------
solutions of Cr(III) resulted in percentages of absorption which were not statis-


tically  different  from absorption  experiments  under  the  same  conditions  for


Cr(VI).  However,  at concentrations  from 0.261 to 0.398 M, significantly more of


the Cr(VI) compound was absorbed.  Absolute absorption rates for chromic'chloride


were maximal with application of 0.239 to 0.261  M solutions,  reaching levels of

                             p
315 to 330 n moles Cr/hour/cm .   In  contrast, absorption rates of sodium dichro-

                                                       p
mate reached a maximum of 690 to 725n moles   Cr/hour/cm  at  a concentration of


0.261 to 0.398 M,  the maximum absorption was 4$  for the 0.261 M solution.


     In conclusion, percutaneous absorption of chromium is  dependent on valence


state, anionic form,  the concentration and pH of the applied  solution.





5.2.  CHROMIUM TRANSPORT,  METABOLISM, DISTRIBUTION, AND ELIMINATION





5.2.1.  Transport and  Metabolism. The mechanism of chromium transport is depen-


dent upon  the valence state  after  reaching the  bloodstream.   Cr(VI)  readily


crosses erythrocyte membranes.  Kitagawa et al. (1982) demonstrated in vitro the


inhibition of  Cr(VI)  penetration into erythrocytes  by 4-acetamido-V-isothio-


cyano-stilbene-2,2'-disulfonic  acid,  an inhibitor of  anion   transport.   After


entry, the Cr(VI)  undergoes  reduction to Cr(III)  and  this reduction  has been


investigated  in other cell systems.   In  studies with cultured  hamster fibro-


blasts, Levis et al.   (1978)  have shown that only Cr(III) could be identified


intracellularly following  treatment with potassium  dichromate.   The mechanism


for intracellular  reduction is not completely understood.  Several investigators


have proposed a role  for the  mixed function oxidases.  These proposals are based


upon  the reduction  of mutagenic  activity  following  addition  of  microsomal


preparations to Cr(VI) (Gruber  and  Jennette,  1978; Lofroth,  1978;  Petrilli and


DeFlora, 1978a).   While rat  liver  preparations  are  very effective  in reducing
                                      5-8

-------
mutagenic activity, lung preparations show  only  minimal activity (Petrilli and



DeFlora, 1978b).   Addition of reduced cofactors,  such  as GSH,  NADH, or NADPH,



also  resulted  in  reduced  activity.   Langard  (1979)  presented  evidence  that



although reduction of Cr(VI)  may take  place  at any intracellular  site where



electron donors are available (which includes the microsomes), the primary site



of reduction  is  within the  mitochondria.   In relation  to  chromium  binding to



hemoglobin, Kitagawa et al.   (1982)  reported that  the  reduced cofactor GSH was



necessary for the in vitro binding of Cr(VI) to purified hemoglobin,  suggesting




that either the chromium or the hemoglobin has been  reduced for binding to occur.



Evidence that the reduction of Cr(VI) to  Cr(III)  may be of biological importance



was provided by Aaseth et al. (1982).  Cr(VI)  was shown to bind to erythrocytes



under  in  vitro incubation  conditions.   When  GSH  was  added  to  the  incubation



media, the binding of chromium to the erythrocytes decreased as a result of the



reduction of Cr(VI) to Cr(III)  and the inability of Cr(III) to  penetrate the cell



membrane (Aaseth et al.,  1982).   Reduction of chromium binding was also observed



when intracellular GSH was decreased by  the action of  diethylmaleate.   In this



case, it was proposed  that  the  lower  binding resulted from the failure to reduce



Cr(VI) to  Cr(III)  in  the  cytosol.   Jennette   (1982) demonstrated  that  a Cr(V)



intermediate was formed during the in vitro reduction of  Cr(VI) to Cr(III) by rat



liver microsomes and that this intermediate  may be the  chemically reactive form



of chromium.



     Localization in vivo of Cr(III)  within  the body cells of the rat appears to



be time  dependent, with  initial high  concentrations   within  the cytosol  and



subsequent translocation to mitochondrial and nuclear fractions (Langard, 1979).



In addition,  the  partitioning  of intracellular chromium  appears  to be  dose



related.   Tandon et al.  (1979)  found  that chromium nitrate(III) doses of  1, 2 or



3 mg/kg administered intraperitoneally resulted  in an  increased  percentage  in
                                      5-9

-------
the mitochondrial  fraction  with increasing  dose.    Early hypotheses  assumed



intracellular binding of Cr(III) to proteins; however,  in vitro data developed by



Sanderson (1976) indicated that intracellular chromic  ion exists in the form of



coordination complexes with small organic anions.  For Cr(VI),  Alexander et al.



(1982)  found  that  the relative chromate  uptake  in rat  liver  mitochondria



decreased with increasing  chromate dose.



     Transport of Cr(III)  is facilitated by specific binding  with transferrin



(Hopkins and Schwartz, 1964).   Following very large doses, binding  with other



serum proteins occurs.  Red blood cells appear to be essentially impermeable to



Cr(III).  Impermeability  of all cell  membranes  to  Cr(III) compounds  has  been



traditionally accepted; however, Levis et al. (1978) have shown uptake of CrCl_



by cultured hamster fibroblasts.  In  addition, Tandon et  al.  (1979)  have shown



significant  intracellular levels  of  chromium  following in  vivo exposure  to



Cr(III) nitrate.



     A  number of  investigators  have demonstrated  that  in  pregnant  rodents



exposed to inorganic chromium only a very  small fraction of the administered dose


                                                               51
is transported to the fetus  in utero.  Visek et al. (1953)  gave   Cr, as a single



dose,  in the form of  sodium  chromate(VI) or chromium chloride(III)  intravenously



to rats on days 15  to 20 of gestation. Fifty pCi per dose was administered, and



specific activity ranged from 200 to 1250  pCi/mg.  Litters were examined 2U hours



post-injection.  Regardless of chemical form or time of administration, recovery



of   Cr per total litter never exceeded 0.13$ of the administered  dose.



     Mertz  et al.  (1969)  administered   Cr  as  chromium acetate(III)  to rats.



Single doses were given either  intravenously or  by  gavage  at mating.   Repeated



doses were given either by daily intubation during gestation or by administration



in the drinking water, at  a  concentration of 2 mg/£.  Five pCi were given intra-



venously and either 5 or 250 pCi by gavage.   Specific activity ranged from 30 to
                                      5-10

-------
100 pCi/pg.  Pups were sacrificed no later than 3 hours  following birth.  No   Cr



was detected in the young at birth following a single dose by either route to the



dam at mating.  Repeated dosing by gavage during gestation resulted in labeling



of  the  litters at birth  with  from  0.5  to  1.5$  of  the mothers'  total  body



activity.  Exposure of dams via the drinking water did not result in transfer of




51Cr to the litters.



     Danielsson et al.  (1982)  found considerable differences between Cr(III) and



Cr(VI) in their distribution in embryonic and fetal uptake.  Forty-two pregnant




mice received single doses (5  pg/kg intravenously) of CrCl_ or Na-Cr^O™ on days 8



to 18 of gestation.  On  day 13 of gestation,  embryonic concentrations  were 12%




Cr(VI) and 0.4$ Cr(III).   Fetal  concentration of both compounds increased with



gestational age, probably binding to  fetal calcified bone, which develops on day



14.



     lijima et  al. (1983) found that radiolabeled  Cr  levels  in  fetal  tissues



increased, while levels in maternal blood decreased after single intraperitoneal




injections of 9.8 mg Cr  (as   CrCl,)/kg body weight.



     Matsumoto et al. (1976)  examined placental transfer following subcutaneous



administration of  CrCl-(III) to  ICR  mice.   Six control mice were injected with



saline, 11 mice were injected with CrCl,  (as  Cr) at a  dose  of 9-76 mg/kg,  and



6 mice were injected with  19.52  mg/kg.  Mice  were  injected 9 times every other



day from the first to the sixteenth day of gestation.



     Although there appeared  to  be  a trend of  increasing chromium in  the pups



with dose, levels  were  not significantly different from controls for either dose



group.  The  high  dose dams did  exhibit placental  chromium concentrations that



were significantly elevated above controls.




     In contrast to these studies, when   Cr was administered to rats in the form



of glucose tolerance factor (a low molecular  weight organic complex isolated from
                                      5-11

-------
yeast) by  stomach  tube during gestation,  from 20 to  50$ of the  dam's radio-



activity was detected in the litters  (Mertz  et al.,  1969).   This is consistent



with the role of chromium as an essential trace element.



     In conclusion, the limited data indicate that small amounts of chromium are



transferred from mother to offspring.   In one study,  embryonic and fetal uptake



of Cr(VI) was approximately 10  times higher than that of Cr(III), when both were



administered at the same doses  to pregnant mice.  In light  of the limited work



that has been done  in this area, it is clear that further investigation is called



for, particularly with regard to uptake in the early  fetus.








5.2.2.    Distribution.




     5.2.2.1.  BLOOD  —  Once absorbed,  Cr(III)  compounds  are  cleared  rapidly



from the blood and more slowly from the tissues.   This also indicates that blood-



chromium levels are  inadequate indicators  of body burden.   Clearance of Cr(VI)



from the blood is slower, presumably  due to  uptake by  erythrocytes followed by



reduction to the relatively impermeable Cr(III).



     Hopkins (1965)  injected  0.1  pg   Cr  (as chromium chloride)/100 g intra-



venously in male rats. The blood chromium content as  a percent of the 15 minute



blood concentration at various  time  intervals was: 30 minutes, 94$; 1 hour, 87?;



2 hours, 69?; 4  hours, 66$;  8 hours, 47$; 24  hours, 17$; 48 hours, 9$; 96 hours,



5$.  Withey (1983)  replotted this on semi-log paper and resolved the curve into



initial, intermediate, and  terminal phases with respective  half-lives  of 0.56,



5.53 and 57 hours (Figure 5-1).   A  correlation  coefficient  of 0.98 was derived



when these data were fit to a linear curve (Y = a+b In x).



     Visek et al.  (1953) compared clearance  and distribution  following intra-



venous injection of several chromium salts in rats.   Four days following injec-




tion, NaCrCL (III)  blood  levels were <0.02$ of the administered dose per gram of
                                      5-12

-------
        Q.

        2
        HI
        oc
        u
        oc
                                                    57 HOURS
             2-
                t% = 0.56    \
                      HOURS   \
                        I        J        I         I
                       20       40      60       80

                          HOURS AFTER INJECTION
100
Figure 5-1.   Rate of blood clearance of intravenously injected   Cr (III)
             from male rats.  Data from Hopkins  (1965) as replotted by
             Whitney (1983).
                                 5-13

-------
blood and CrCl^  (III)  levels were 0.05$ of  the  administered dose per  gram of
blood.  In contrast, Na^rOjjUl) levels 4 days post-injection represented 0.52$



of the administered dose per gram of blood.  Nearly complete blood clearance for



this salt was not achieved until 42 days post-injection compared with only 7 days



for the trivalent salt.



     Baetjer  et al.  (1959a)  administered Na^rO^ (VI), K2Cr20?  (VI),  or CrCl3



(III) intravenously to guinea  pigs.  For  the Cr(VI) salts, values of pg Cr/10 gm



dry tissue/200 pg Cr injected for erythrocytes 1 and 3 days post-injection were



28 and 31, respectively, and for plasma,  4 and 2, respectively.  For the Cr(III)



salt, erythrocyte values at the 1  and  3  day  time points were 1  and <1, respec-




tively, and plasma values were 5 and 3, respectively.



     5.2.2.2.  OTHER  BODY  COMPARTMENTS  —  Visek et al.  (1953) have  reported



organ distribution of several chromium salts following intravenous injection in



rats.  Sodium chromite (NaCrO.)  (VI) was  concentrated in large quantities by the



reticuloendothelial system, which in combination with the liver accumulated 90$



of  the  dose.   At  42 days post-exposure,  organs with detectable  levels were:



spleen >  liver > bone marrow >  tibia epiphysis  >  lung >  kidney.   The liver and



spleen contained 33 and 50$ of their 4  day values, while the lung contained 10$.



The  extensive accumulation of  chromite  in  the reticuloendothelial system  is



postulated  to  be  the  result  of  the  formation of colloids  by chromite  at



physiological pH.



     Chromic  chloride  concentrated  in  the liver, spleen and  bone  marrow; once




deposited, it cleared slowly.  At 4 days post-exposure,  CrCl, exposed animals had



lower percentages  of the total dose in  their  livers, spleens,  and bone- marrow



than those exposed to NaCrO .  More CrCl, than NaCr02 accumulated in the kidney,



however.  All organs gradually cleared  chroraite  over  the period of the study.  In



contrast, the liver in CrCl., -exposed rats was the only organ to clear significant



amounts of chromium over the study period (45 days).





                                      5-14

-------
     Cr(VI) was picked up  to a much smaller  extent  than  either of the Cr(III)




salts.  At the 42-day time point, <1$ of the  dose was  found  in  the liver.   For




comparison with  the  trivalent  salts,  4-day  tissue  concentrations  in animals




given sodium chromate were  (% dose/g  tissue):  liver, 0.52$; spleen, 0.91?;  bone




marrow, 0.56?; tibia  epiphysis,  0.38$.   At  42 days,  corresponding values were:




liver, 0.07$; spleen, 4.8$;  bone marrow, 0.16$; tibia  epiphysis,  <0.02$.   The




increase in spleen concentration was attributed to erythrocyte destruction.




     Hopkins  (1965) examined the kinetics of distribution with trace quantities




of chromic  chloride in the  rat.   Measured concentrations at  15 minutes post-




injection were highest in  lung  and kidney,  followed  by heart,  pancreas, liver,




bone marrow,  spleen,  testis,  and  brain.   The  heart,  lung, pancreas, liver, and




brain  showed  maximal  levels at  this  15-minute  time  point, and subsequently




declined.   The  spleen reached  a maximum level  96 hours  post-exposure and the




testis 4 hours  post-exposure (300 times  the  initial level), while  the kidney




concentration remained unchanged over 96 hours.




     Following intratracheal administration  of chromate  to rats,  highest concen-




trations were found in the lung, followed by  liver, kidney, and  spleen  (Baetjer




et al.,  1959a).   In contrast to the injection  studies, significant concentra-




tions were not found  in bone.



     Following a  single  oral dose of chromate  administered  by  gavage, highest




concentrations were  found  in the liver,  followed by the  kidney and the spleen




(MacKenzie et al.,  1959).  When chromate was  administered  in the drinking water




for  1  year,  highest concentrations were  found  in the  spleen,  followed by the




kidney, liver, and bone.  Year  long administration of chromic chloride  resulted




in the same type of distribution pattern with lower absolute quantities.




     Generalizations  regarding  the  behavior of  the   two valence  states are




difficult  to  make,  since  almost all  testing has involved  chromic  chloride(III)
                                      5-15

-------
and sodium chromate(VI) or potassium dichromate(VI).   The  data of Visek et al.



(1953) showed  differences  in uptake and distribution  between  chromic chloride



and chromite; the behavior of other Cr(III) salts  is  difficult to anticipate.



Data from  chromium  chloride(III)  do indicate that  once absorbed,  this salt is



quickly cleared  from the bloodstream  and  has  a long tissue  residence  time.



Cr(VI) salts  have  longer  residence times  in  the  blood and  are  more rapidly



cleared from the  tissues.   Comparisons of  tissue distributions are difficult,



because different authors choose  different organs to  examine  and  time between



exposure  and  analysis  varied  considerably.   In  almost  all instances,  the



following  organs  accumulated significant  amounts  of  chromium:  liver, kidney,




spleen, and bone marrow.  In addition, there are  some  data which indicate that



the testis,  heart,  lung, and  brain accumulate  considerable  amounts.   Tissue



distribution does not  appear to  be  affected by  the  sex   of  the animal  or by



dietary history in terms of chromium content.



     In humans, Teraoka  (1981)  studied the  distribution of  24 elements  in 12



Japanese males.  The samples  obtained at autopsy were from seven workers exposed



to heavy metals and five subjects with no  undue exposure.   Although absolute



concentrations of chromium varied  extensively between individuals,  the greatest



concentrations of chromium were found in the Hilar lymph nodes and lungs followed



by spleen, liver, kidney, and heart which  all contained approximately the same



level for each individual.  The distribution patterns were similar for the seven



men occupationally  exposed   to  metals  and  the  unexposed  control  group.   The



average level of chromium in  the Hilar  lymph nodes of unexposed men was 8.2 ppm



as compared with 2400 ppm for the two  chromium  plating workers and 152 ppm for



the three chromate refinery workers.   An airplane painter and stone mason who had



possible exposure to chromium had levels of 33  and  4.2 ppm,  respectively.  The



order of organ  distribution  appeared  to be  similar regardless of  whether the
                                     5-16

-------
exposure to  chromium  was  from occupational (high levels) or environmental  (low



levels) sources.



     Similarly,  the highest  levels  of chromium were detected at autopsy in the



lungs of a worker who died of respiratory  cancer  10 years after retiring from a



chromate  manufacturing  plant  (Hyodo et al.,  1980).    The  chromium  levels in



different portions of the lungs  of  this  worker varied from  616 to 7100 ng Cr/g



wet weight  as  compared  to values of 19-3  to 881  ng Cr/g wet weight of similar



lung sections from five  control subjects.  The  suprarenal gland, brain, and skin



also had relatively high  levels  of  chromium as compared to the control values.



It was reported  that Cr(VI) was more prevalent in the chromate worker; however,




the wet  oxidation method, using  hot nitric acid and  perchloric  acid,  has the



potential of oxidizing Cr(III) to Cr(VI) and makes these results invalid.



     Lim et  al.  (1983)  conducted a  study  of radiolabeled  Cr kinetics in three



normal and  three hemochromatotic patients used  in a  previous  study.   After



intravenous injection of   Cr(III),  absorption and distribution were determined



with a whole body gamma-ray scintillation  scanner, whole body counts and plasma



clearance determinations.  Among  all body  organs  studies,  the liver and spleen



contained the highest levels.  In fact, after 3 months the liver contained half



of the total body burden of chromium.   For  the  liver,  spleen and thigh, there



were three  major accumulation and  clearance components, grouped in  ranges of



half-lives of  0.5  to  12 hour (fast), 1  to 1U  days  (medium)  and  3 to 12 months



(slow).  More than 50? of  the blood plasma  of chromium was absorbed within hours



of administration.  On the basis  of this study,  a model was constructed in the



form of  a  plasma pool in equilibrium with  the  three compartments.   The  fast



compartment occurred in adipose and  muscle tissues;  the middle compartment was



distributed equally between adipose and muscle tissues,  and the liver and spleen;



the liver and spleen composed the slow compartment.
                                     5-17

-------
5.2.3.  Elimination.  Hopkins (1965) examined the kinetics of single doses of 0.1



or  0.01 pg  Cr  administered intravenously  as   CrCr..   Urinary  excretion  was



followed  over  4 days,   and  an  inspection   of  a  semi-log  plot  of these  data



indicated at  least two elimination components,  the first representing  rapid



blood clearance  of chromium and  the  second the  slower elimination  from  soft



tissues.  Hopkins  data also indicate  that, although the urine  is  the primary



route of excretion, the intestines also play a small role.



     Mertz  et al.  (1965)  followed  the elimination  of  single doses  of  intra-



venously  administered  chromic  chloride  over a longer  time  period  (72 days).



Whole body  retention  of  chromium as  a  funtion  of  time  was  represented by  a



polynomial  with  three  distinct regression  terms  (Figure  5-2).   This evidence



supports a three compartment elimination process.  The half-lives  for chromium in



the  three compartments were  estimated  from clearance rates  to be  0.5 days,



5.9 days, and 83-4 days.  At the end of 72 days,  13.5$  of the  original dose  was



retained.



     Onkelinx (1977) also  followed elimination  of an  intravenous dose of chromic



chloride.   Their  data agree  with Mertz  et al.   (1965),  in  that the  plasma



disappearance curve could be described by the sum  of  three exponential compo-



nents, representing three compartments.   Excretion  has been quantified and  3



components have been identified.   Urinary excretion  represented 51 to 64? of the



total excretion, fecal excretion 5 to 8$, and clearance of chromium into a  body



"sink" 31 to 41$.   The sink represents  compartments with  extremely long half-



lives.



     In a comparison of Cr(VI) and Cr(III)  elimination in  rats, Sayoto et  al.



(1980) administered radiolabeled  Na-CrO^ or  CrCl,  to animals  either by intuba-



tion or intravenous injection.  Regardless  of  the route of administration,  the



Cr(VI) compound  was  excreted  more  rapidly  through the feces  and urine.   The
                                      5-18

-------
  100
UJ
U
cc
   10
I     V
t%  •  5.9 DAYS


      t% * 0.5 DAYS
               I        I       I
              10      20       30      40       50

                             DAYS AFTER INJECTION
                                I
                               40
                                           I
                                          60
70
 I
80
    Figure 5-2*. Whole-body elimination of intravenously administered
              5 Cr (III) in male rats (Mertz et al.v  1965).
                                  5-19

-------
biologic half  life  for  Wa^rO^  and CrCl, after intubation  was 22.24 and 91.79



days,  respectively.   The authors suggested that  these  findings indicated that



Cr(III) has a higher affinity for body constituents than Cr(VI).



     Yamaguchi  et al.  (1983)  studied  the  excretion of a Cr(III)  and Cr(VI)




following subcutaneous administration to  rats of CrCNO^)- and KpCrpO.,.  Within 24



hours  after treatment 93.6$ of the Cr(VI) was  removed  from the  site of injection



while  only 21.3$  of the Cr(III) was  adsorbed.   In 7 days, 48 and  8.0$ of the



Cr(VI) and Cr(III),  respectively,  were eliminated in the  urine.   The biologic




half-time of Cr(VI) in different organs was determined,  with half-times for the



terminal component  for  lungs,  liver, kidney, brain,  heart,   testes  and  blood




calculated to be 20.9, 15.7, 10.5, 9.6, 13.9,  12.9 and 13.9 days, respectively.



     Collins  et al.  (1961)  examined chromium excretion in dogs  dosed intra-



venously with chromium chloride  or  sodium dichromate.  Acute exposures (dose not



stated) showed  that 25$  of the Cr(III)  salt and 9$  of the  Cr(VI)  salt were



excreted in the urine within 4 hours.  Less than 0.5$ appeared in the bile.



     In bile fistulated dogs, 4-day excretion  values were 50$ in the urine, 0.5$



in the bile, and 3.7$ in the feces for the Cr(III)  salt, and  20, 0.9, and 1.2$ of



the dose in urine, bile, and feces,  respectively,  for the Cr(VI) salt.  Excreted



chromium was readily dialyzable  indicating that,  if the chromium was bound, the



molecule it was combined  with was  of small  size  or the binding was reversible.



Tubular reabsorption appeared to represent >63$ of the amount filtered.



     Davidson et al. (1974) examined kidney handling of chromium in normal human



subjects and in dogs  (not pre-treated with chromium).   Their  results indicate



that in  both dogs  and  man  physiological quantities of chromium have a  >99$



reabsorption value.   Their data also  suggest  that  there  is  an  active transport



mechanism in the renal tubule for chromium reabsorption.   They  hypothesize that



the normal filtered  load for chromium may be  close to the  maximal reabsorption
                                     5-20

-------
rate.  If this is the case, then any  increase  in plasma chromium concentration



would result in a significant increase in renal excretion of chromium.



     Cikrt and Benco  (1979) measured  the excretion of   Cr  in  urine,  bile and



feces  of  rats  within  24 hours   after  intravenous   injection  of TCrCl_  or



NapCrOjjGijmol/kg).    Cr excretion  in  urine (as a fraction of the dose) averaged



22.4 + 2.8$ for  Cr(VI);  51Cr  excretion in bile averaged 0.5 + 0.1$ for Cr(III)



and  3.5  +   0.7$  for  Cr(VI);   and    Cr  excretion  in   feces  (including



gastrointestinal  contents) averaged 4.2 + 0.2$ for Cr(III)  and 7.4  + 0.4$ for



Cr(VI).  These measurements indicate that urinary excretion of CR(III) and Cr(VI)



are equivalent, but biliary excretion of Cr(VI) averages 7-fold that of Cr(III)




under the same conditions.



     Norseth  et  al.  (1982)  administered  51CrCl3 and  Na2  CrO^ to  rats  by



intravenous  injection   (1-9  pmol/kg)   and  identified    Cr(III)-glutathione



complexes  in   bile  after  the  administration  of  both compounds.   They  also



demonstrated that biliary  excretion of the Cr-glutathione  complex is inhibited



by  diethylmaleate.     This  experiment   furnishes   important   evidence  that



glutathione is involved in the  biliary  excretion of chromium.   Yamamoto et al.



(1982) isolated  a low-molecular-weight, chromium-binding constituent  in liver



and  kidney  cytosol  of  mice  treated  with Cr(VI);   the  low-molecular-weight



chromium  constituent  was also  detected  in urine and   feces.   Alexander  et al.



(1982) showed  that  rat liver mitochondria accumulated Cr(VI)  fairly  rapidly,



although the relative uptake decreased with increasing  dose.  Trivalent chromium



was taken up at a much lower rate than hexavalent chromium.








5.3. SUMMARY








     There are increasing experimental data available on the pharmacokinetics of



chromium.  Absorption by inhalation exposure appears to occur rapidly, although
                                      5-21

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it is difficult to quantify the extent of absorption.  A preliminary estimate of



pulmonary  absorption,  following  disposition  of  CrCl-  into  the  lungs  by



instillation,  indicates  that approximately  5%  is  absorbed.   Following  oral



exposure, gastrointestinal absorption was also low with estimates that only 5% or



less of chromium was absorbed.  In vitro studies indicate that gastrointestinal



juices have  the  capability  to  reduce  Cr(VI) to  Cr(III);  however, there  are



insufficient data from  in vivo  studies  to demonstrate whether this  reduction



process  has  the capacity to  eliminate any  differences in  absorption  between



ingested  Cr(VI)  and Cr(III)  compounds.    Percutaneous  absorption  of  chromium



through  unbroken  skin is  variable  and  dependent on  valence as  well as  the




specific salt.



     After absorption, chromium is transported by the blood with  Cr(III) trans-



port facilitated by  specific binding proteins in the blood.  Cr(VI) on  entering



the blood stream  diffuses  into  the blood  cells  where  reduction and binding to



cellular components  occurs.  Both absorbed Cr(III) and  (VI) can be transported to



a limited extent to  the fetus in  utero after  exposures of the dams, although the



data do not allow quantitative estimates of fetal  exposure.  Chromium transported



by  the blood  is  distributed to  other  organs with  greatest retention by  the



spleen, liver, and bone marrow.   The major deposition site following inhalation



exposure  is  the  lungs,  where chromium probably  binds  to  the cellular  material



before absorption can occur.



     Absorbed chromium is eliminated from the body in a rapid phase representing




clearance from the  blood and in a slower  phase  representing clearance  from



tissues.   Urinary excretion is the  primary route of elimination  accounting for



somewhat over 50$ of the  eliminated  chromium,  while fecal excretion accounts for



only 5% of the elimination from the blood.  The remaining chromium is deposited



into  deep body  compartments.    Limited  work  on modeling  the absorption  and
                                      5-22

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deposition of chromium indicates that adipose and muscle tissue retains chromium



at a moderate level (-2 weeks),  while the liver and spleen store chromium for up



to 12 months.  Estimated half-lives for  whole  body chromium elimination are 22



and 92 days for Cr(VI) and Cr(III), respectively.
                                     5-23

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                     6.  CHROMIUM  AS  AN ESSENTIAL  ELEMENT








6.1. CHROMIUM DEFIENCY








     The nutritional need for chromium as an essential element has been reviewed



by Golden and  Golden (1981), Anderson  (1981),  Saner (1980) and  Mertz (1974).



Mertz (1974) described  the  necessary components for considering  an  element as



essential.  These components are: the element must be  found in living matter, the



element must  interact with  living biological  systems,  and deficiency  of the



element must   produce  a decrement in  biological  function.    Indeed,  certain



chromium  compounds  are  found  in  living matter,  it does interact with living



systems, and deficiency syndromes are remedied with its supplementation.



     The National Academy of Science (NAS,  1980)  has  summarized  daily intakes of



chromium by persons  in the United States as: dietary,  a range of  37 to 130 pg/day



with an average of 62 pg/day;  air,  a range  of <0.5 to <4.0 of the dietary intake;



and drinking water,  a range of  0  to 224  pg/day with an average  of  17 pg/day.



Mertz (1974) provided similar estimates that daily  intake of chromium in healthy



humans was between 5 and 100 pg/day and that  this  intake resulted in blood and



urine levels of chromium of 0.5 to  5  and  5 to  10  pg/fc, respectively.   Infants



receive chromium through breast milk during nursing (Kumpulainen et al., (1980).



These levels of chromium intake must be adequate since no  serious effects from



chromium deficiency  have been  observed  in  the general  populace.  The Estimated



Adequate and Safe Intake (EASI) values for chromium,  provided  by the National



Academy of Science  (NAS, 1980), are listed in Table  6-1.  The lower EASI values



are  based  on  the average  United  States  daily  intake  from a  mixed diet.   No



Recommended Daily Allowance (RDA)  has been issued.
                                      6-1

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                                TABLE 6-1



          Estimated Adequate  and Safe Intake (EASI) for Chromium*








                    Age (years)              EASI (mg/day)
Infants

Children



0.0 to 0.5
0.5 to 1.0
1 to 3
4 to 6
7 to 10
>11
0.01 to 0.04
0.02 to 0.06
0.02 to 0.08
0.03 to 0.12
0.05 to 0.20
0.05 to 0.20
Adults                                      0.05 to 0.20
•Source:  NAS, 1980
                                  6-2

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     Animal studies have been conducted to determine  the effects of ingestion of




dietary chromium.  Schroeder et  al.  (1964)  maintained 54 male and 54 female mice




for life  on  drinking water  containing 5  ppm of Cr(III).   The  mice  exposed to




chromium had survival rates  similar  to those of control  animals  and  mean body




weights that were 123? of control values.   In this study the food was devoid of




all trace metals.  In an identical study using groups  of 50 male and female Long-




Evans rats, Schroeder et al. (1965) observed increased longevity in the treated




animals.   In  studies of the  effects of  the  absence of chromium in  the diet,




Roginski  and  Mertz  (1969)  raised  rats in  plastic  cages on low  protein diets




containing less  than 100 ppb Cr(III).   A  second  group  of rats were  given  a




chromium  supplement  of  2  ppm  Cr(III) in  the  drinking  water.   The  chromium




supplemented rats had better weight gain  than  the  chromium deficient animals.




This difference in weight gain was  more striking if the animals were allowed free




access  to an exercise  wheel.    When extreme care  was  taken  to also  prevent




airborne  exposure to  chromium of rats maintained on chromium  deficient diets,




there was a high incidence of moderate hyperglycemia and glycosuria as compared




to animals  on chromium supplemented  diets.   These  studies suggest  that small




amounts of dietary Cr(III) were  beneficial to  the health of these rats.  Preston




et al.  (1976)  maintained female guinea  pigs on  low protein diets  containing




0.125, 0.5, or 50 ppm chromium  along  with adequate  levels of vitamins and some




other trace  metals.   After  8  to  13  weeks of maintenance  on these  diets,  the




animals were mated and allowed to deliver pups.  Although the diets had no effect




on the  survival  of  animals  not mated,  there  was  a  significant decrease  in




survival  of mated animals on the low chromium diet  (13 of  24 animals  died)  as




compared to animals on the low chromium supplemented  diet  (4 of 24 animals died)




and the high  chromium supplemented diet (3  of 24  animals died).  It was suggested




that  the  added  stress of mating and  pregnancy along with chromium deficiency
                                      6-3

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resulted in  the  high level of  mortality.   Other  parameters examined included



weight gain  and  glucose loading; serum cholesterol  levels  were not altered by



dietary chromium.  It was concluded that chromium was beneficial to survival in



guinea pigs as was previously reported for mice and rats.








6.2. GLUCOSE TOLERANCE FACTOR








     Chromium deficiency in the diet results in glucose intolerance in both the




experimental animals and humans  (Saner,  1980).  Schwarz  and Mertz (1959) have



identified a glucose tolerance factor (GIF) which was required in rats to main-




tain normal rates of glucose removal from the blood  stream. This factor has been



obtained  from natural  sources  including  brewer's  yeast and  hydrolyzed pork



kidney.  In  further  studies,  Mertz and  Schwarz (1959) demonstrated  that rats



maintained on  some commercial  diets  had  normal  glucose removal  rates,  while



maintenance on other diets resulted in poor  removal  of glucose from the blood.



When the second diets were  supplemented with  GTF, glucose  removal rates returned



to normal values. Mertz and Schwarz (1959)  have identified Cr(III) as the active



agent in the GTF.  It was further demonstrated that administration of a variety



of Cr(III) compounds to glucose  intolerant rats resulted  in  an increase in the



rate of  removal of  glucose  from  the  blood.   In  this assay,  the  less stable



Cr(III) compounds were  most  effective,  and some Cr(VI)  compounds  were totally



without activity.



     The effects of chromium on glucose metabolism were suggested to result from



chromium being a  co-factor  for insulin.   Mertz et al.  (1965)  measured insulin



stimulated  C0?  production  in  adipose  tissue  from  chromium deficient  rats



receiving supplements of 0.0,  0.01, 0.05,  or  0.1 pg  Cr/100 g body  weight.  The



adipose tissue  of rats  receiving 0.05 pg  Cr/100 g produced  significantly more
                                      6-H

-------
COp  than  tissues  obtained  from other groups.   Farkas  and Roberson  (1965)  per-



formed  similar  studies with measurements of  glucose  utilization in rat lenses



taken from  animals  on chromium deficient and supplemented diets.  The chromium



treatment alone did not affect glucose utilization; however, chromium treatment



in conjunction with insulin significantly increased the utilization  of glucose.



Administration of 2 ppm of chromium in the drinking water of rats also facili-



tated the insulin transport of amino acids into the heart and the incorporation



of amino  acids  into protein.   Providing chromium supplements to rats increased



the  animals' sensitivity to many of the effects of insulin.



     Saner  (1980) states that certain groups of persons may be prone  to chromium




deficiency;  these  groups   include  the   elderly,  diabetics,   pregnant  women,



malnourished children,  offspring and  siblings of diabetics,  persons with early



coronary  heart  disease and  their  offspring.   Jeejeebhoy  et   al.  (1977)   have



described a female patient placed on total parenteral nutrition for  3 1/2 years



in whom chromium  deficiency was indicated.  Blood chromium levels were reported



as 0.55  ng/mJl  and hair  chromium  levels as  154 to 175 ng/gm.   In addition to



glucose  intolerance,   weight  loss,  neuropathy,  elevated fatty  acid  levels,



reduced respiratory quotient,  and  abnormal  nitrogen  metabolism were reported.



Daily administration of 250 pg chromium  chloride  for  2 weeks in the parenteral



infusate, followed by  20 pg/day maintenance,  resulted in a reversal of symptoms.



Freund et al. (1979) report similar finding of chromium deficiency in a patient



receiving total parenteral  nutrition.  Supplementation of the infusate with 150



pg chromium/day resulted in  the reversal of the adverse clinical  findings of



impaired glucose tolerance, weight  loss,  and confusion.



     Chromium has  been known to affect glucose tolerance  in humans.  Levin et al.



(1968)  performed  oral glucose  tolerance tests  on 9 male and 6 female  elderly




subjects.   Of the  subjects  tested,  10 daily  dietary supplements  with 150 pg/day
                                      6-5

-------
chromium for 3 to 1 months resulted in normal glucose tolerance in four subjects.



The remaining six subjects still  had abnormal tests after receiving the chromium



supplement.  Glinsmann and Mertz  (1966)  observed  improved  glucose  tolerance in



three of six diabetics given 150 to 1000 yg of Cr(III)  for  15 to 120 days.  In a



similar study,  Sherman et al.  (1968) observed no change in the glucose tolerance



of ten diabetics who  received chromium  supplements  of  100  pg/day  for 16 weeks.



In malnourished  infants, Gurson  and  Saner  (1971)  and Hopkins  et al.  (1968)



observed dramatic increases in glucose removal and utilization following treat-




ment with Cr(III).   To ensure  that  the improved glucose tolerance was the result



of chromium therapy,  Hopkins et al.  (1968) treated  five  infants  in  a manner




similar to  the  others with the  exception  that chromium was  not  administered.



These five infants showed no improvement in glucose tolerance.  Dieatary chromium



appears to have some effect on human glucose tolerance; however, the therapeutic



effect of  chromium  supplementation on subjects with abnormal glucose tolerance




was variable.








6.3- SUMMARY







     Animal studies have demonstrated that chromium deficient rodents gain less



weight and  have a shorter lifespan than animals maintained on a diet containing



adequate chromium levels.  Chromium deficiency  results  in glucose intolerance in



rats and  this  intolerance can be  reversed by dietary  treatment  with Cr(III).



More effective in reversing glucose intolerance is a chromium complex which has



been  isolated  from brewer's  yeast and  designated as  glucose  tolerance factor



(GTF).  GTF may be  formed  in  mammals following ingestion of inorganic chromium.



Some humans with abnormal glucose tolerance,  such  as the elderly, diabetics, and



malnourished   infants have   responded   to dietary  supplements  of  chromium.
                                       6-6

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Although the exact level of chromium needed for good health is not known, it is



assumed from the lack of observed effects of chromium deficiency that the average



American intake of 0.05  to  0.2 mg/day is adequate.  It is also worth noting that



there is a considerable  difference between the low levels of chromium intake that



are associated with nutritional  deficiency,  and those discussed in the following



Chapter 7 which have been associated with toxic effects.
                                      6-7

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                            7.  CHROMIUM TOXICOLOGY








7.1. ACUTE EFFECTS OF CHROMIUM EXPOSURE IN MAN AND ANIMALS








7.1.1.  Human Studies.   Chromium metal is biologically  inert  and  has not been




reported to produce toxic or other harmful effects in man.  When in contact with




the skin, compounds of chromium in the trivalent state combine with proteins in




the superficial layers, but do not cause ulceration (NAS, 1974).




     Cr(VI) compounds  are responsible for the majority  of  the health problems




associated with all chromium compounds.  They are irritating and corrosive, and




may be  absorbed by inhalation,  cutaneously,  or by  ingestion.   Acute systemic




poisoning is rare; however, it may follow deliberate or accidental ingestion or




result from absorption through broken skin (NAS, 1974).



     Much  of  the  information   on  the  effects  of  Cr(VI)  is  obtained  from




occupational exposures, where the predominant exposures and related effects are




on the respiratory system and skin (NAS, 1974).  As with most information derived




from  uncontrolled   settings,  exact  knowledge  about   length  of  exposure,




concentration  of  the chemical,  and  other   variables  are  not known,  making




quantitive dose-effect relationships difficult.








7.1.2.  Animal Studies.  Cr(III) compounds have a very low order of toxicity when




administered orally.  Oral LD,-0  values for the rat have been reported as follows:




chromic  chloride,  1.87 g/kg; chromium  acetate,  11.26 g/kg;  chromium nitrate,




3.25 g/kg  (Smyth  et al.,  1969).  Kobayashi et al.  (1976) have determined oral




LDSO  for chromium trioxide in mice and  rats  to be  135  to  177 mg/kg  and 80 to




114 mg/kg,  respectively,  with  death  occurring   between   3  to  35  hours.
                                      7-1

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Symptomatology included diarrhea,  cyanosis,  tail necrosis, and  gastric ulcer.



Surviving animals  showed  increases in  liver  and testes weight  without micro-



scopic changes.



     Cr(VI)  is  more acutely  toxic than  Cr(III).    A  primary effect  of acute



exposures  is  kidney failure.   Oral administration  of  high  doses  results  in




gastric  corrosion.   The  oral LD^  of sodium  dichromate  in humans  has  been



reported as 50 mg/kg (NIOSH, 1979).



     Kidney effects  are  the primary result  of acute  exposures  to chromium by



various routes.  Relevant studies are summarized in the following paragraphs.




     Mathur  et al.  (1977)   injected   rabbits  intraperitoneally  with  2 mg/kg



chromium nitrate or potassium chromate  daily for 3 or 6 weeks.   After 3 weeks of



exposure, kidneys from animals dosed with  chromium nitrate showed marked conges-



tion, extravasation of red  blood cells in the  intratubular spaces and tubular



necrosis.  Further treatment for 6 weeks did not produce additional changes.



     The kidneys from animals  given potassium dichromate showed  marked conges-



tion, and the walls of the small  blood  vessels were thickened.  Glomerular tufts



were  shrunken  in  some   places,  while  proliferation  of  endothelial  cells,



obliterating  the Bowman  space,  was seen  in  others.   There  was  necrosis  and



desquamation of the epithelium of the convoluted tubules.   Red blood cells were



found  in the intertubular  spaces.   Changes  were  similar  whether animals were



exposed  for 3 or 6 weeks.



     Hunter and Roberts (1933) dosed monkeys  subcutaneously with 1 to 5 m2, of a




2%  solution  of  potassium dichromate  over  a  5-week period.   One  monkey died



following the final dose.   The authors  reported  injury to the proximal and distal



convoluted tubules and the  glomeruli of the kidneys.



     Kirschbaum et al. (1981)  injected  rats subcutaneously  with 20 mg/kg sodium



chromate.   Epithelial cell  injury in   the kidney  occurred 2 to  U hours post-
                                      7-2

-------
injection.   They  postulated  that  the  interaction  of chromium  with specific



elements  of  the microfilamentous  system,  which are  responsible  for directing



intracellular flow of reabsorbed solutes, may be the initial effect of chromium



nephropathy.   Baines (1965)  also reports renal damage  following exposure of rats



to acute, subcutaneous doses of potassium dichromate.



     Evan and Dail (197*0  also report data which indicate effects on the proximal



convoluted tubules  following intraperitoneal administration of 10  or 20 mg/kg



sodium chromate  and  the formation of large  lysosomal  vacuoles  in this region.



They  also report  effects  on   mitochondrial configuration  shortly  following



exposure.



     Berndt  (1976)  reports  in  vitro data  which indicate  there may  be species



differences in kidney susceptibility to chromium nephropathy.  In kidney slices



from rats, effects were  independent of valence state.  Kidney  slices from rabbits



were more sensitive to transport process inhibition by Cr(VI).



     Mathur et  al.  (1977)  documented  effects in other target  organs following



acute exposure  to  chromium.  Rabbits were  dosed intraperitoneally with 2 mg/kg



chromium as chromium nitrate or as potassium dichromate.  Doses were given daily



and the animals were sacrificed after 3  or  6 weeks.   Administration of Cr(III)



for  3 weeks   produced   changes  in  the  brain,   including  occasional  neuronal



degeneration in  the cerebral cortex, marked  chromatolysis, and  nuclear changes



in the neurones.  Six weeks  of exposure  resulted in marked  neuronal degeneration



in the cerebral  cortex  accompanied  by neuronophagia,  neuroglial  proliferation,



and meningeal congestion.



     Following  3 weeks  of  exposure to Cr(VI),  congestion with  perivascular



infiltration by inflammatory cells was noted. In addition, some neurones in the



cortex showed  pyknotic  nuclei  and  dissolution of  Nissl's  substance.   Neuro-




nophagia  and  focal neuroglial  profileration were  also evident throughout  the
                                      7-3

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cerebral  cortex.   Changes  following 6 weeks  of exposure  were similar.   The



myocardium  of animals exposed  to Cr(III)  for 3 weeks appeared  to be normal.



However,  following 6 weeks of exposure, the myocardium showed marked congestion



and  degeneration  of muscle  fibers.    Exposure to Cr(VI)  for 3  weeks did not



produce any abnormalities.   Exposure  for 6 weeks produced  changes similar to



those seen  in animals exposed to the trivalent salt.




     Tandon et al. (1978) report hepatic changes  in rabbits exposed  to  chromium.



Exposure  conditions were the same as in the previous  study.   Exposure to Cr(III)



for  3  weeks produced  marked congestion and  dilation of the  central  veins and



sinusoids.  Discrete foci of necrosis  were noted in liver parenchyma.  After 6




weeks, in addition to  marked congestion, extensive  hemorrhage  was  seen in the



parenchyma.  Slight nuclear pleomorphism and multinucleated cells were noted in



the  lobules.  Bile duct  proliferation,  increased cellularity and proliferation



of fibroblasts around portal tracts were noted.




     Exposure to Cr(VI)  for  3 weeks  produced  more extensive  pathology than did



Cr(III) exposure.  The liver capsule was thickened  and there was marked conges



tion of central veins and adjacent sinusoids.  Large areas of necrosis were seen



throughout  the  parenchyma.   Changes seen  following 6 weeks of  exposure were



similar to those described following 6 weeks of exposure to the trivalent salt.



     In summary,  the  kidney appears to  be the main target  for acute chromium



toxicity,  with  effects  occurring at  1-2  mg  Cr(VI)/kg  body  weight.   Although



hepatic effects have also been observed, the kidney has  received  the  most intense



study.








7.1.3-    Chromium Hypersensitivity.








     7.1.3.1.  CHROMIUM SENSITIVITY  AND CONTACT  DERMATITIS ~ Chromic acid and



the  chromates are  powerful  skin irritants,  and,  in lower concentrations,  the





                                      7-4

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chromates are sensitizers (NAS,  1974).  Workmen exposed to the steam of boiling


dichromate  solutions developed  an acute  primary irritant  contact dermatitis


(Schwartz et al., 1957;  White,  1934).  White (193*0 described  a diffuse erythema-


tous dermatosis  that resulted  from dichromate;  some  progressed to an exudative


phase.


     Various chromium compounds have been implicated in giving rise to allergic


dermatitis with varying  degrees of  eczema.  Parkhurst  (1925) reported the case of


a woman employed in blueprint production using a process  in which a  1$ potassium


dichromate solution was  used as a fixative.  A  Q.5% potassium dichromate solution


was rubbed on the right  thigh of  the woman, and soom after the application, there


was a local sensation of itching and burning.   Twelve  hours  later,  the patient


developed  a  follicular erythematopapular  dermatitis  at the  exposure  site.


Itching and burning was  reported  when a  similar application was made to the left


thigh.


     Smith (193D reported  a case of chromium sensitization in a man  who had been


hospitalized after  occupational  exposure  to ammonium dichromate.   The  patient


had ulcerations in the skin of  both hands, and complained  of asthma, and muscular


weakness and tenderness.  He had a previous history of asthma and hay fever and


had further asthmatic attacks upon  exposure  to chromium.  Following a patch test

                                                 o
with 1/t  ammonium dichromate solution  on  a  1 cm  area of normal  skin on  his


forearm, the man developed  a  mild  erythema after 24 hours.   After  3 days,  the


erythematous area doubled in size,  and there was the appearance of vesicles.   An


intradermal injection of 0.1  m£  of a 0.5$ aqueous solution  of ammonium dichro-


mate was given in the right forearm 8 days later.  Within an hour,  the  patient


developed a  generalized pruritis  with  soreness  at  the  injection site.   This


progressed with the development of  a vesicular erythematous dermatitis covering


the entire hands and lower parts  of the forearm.   In addition, he  developed
                                      7-5

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diaphoresis and sibilant rales.  These  symptoms  which required hospitilization



abated after  his  exposure to  Cr(VI)  ceased.   Three  control  subjects  who were



similarly injected showed no reaction.



     Hall (19^*0 reported on  132 aircraft workers who developed dermatitis after



contact with  a  primer  consisting  of a  suspension  of zinc chromate  powder and



magnesium silicate in a xylene solution of certain resins, including a  phenol-



formaldehyde resin.  Those workers  who  had dermatitis from the  primer and who



were allergic  to  zinc  chromate  pigment had a mean duration of  employment of



7 months (range:  1 week to 9 years).  A  battery of  patch tests showed that 90 of



the workers (68?)  were  sensitive to  the  zinc chromate pigment only. (Apparently,




the zinc chromate  pigment was a mixture  of zinc chromate and calcium carbonate.)



Only a few workers had  positive patch tests  for  other compounds encountered on



the job.



     Forty-five cases of allergic contact  dermatitis,  observed  in the Helsinki



area from  1945  to 1948, were reported  by  Pirila  and Kilpio  (1949).   Positive



patch-testing with a  0.5? aqueous solution  of potassium dichromate (pH 4.15) was



observed in  41  of the  workers.   The  workers were  involved  in  the following



occupations:    11 bookworkers,  10  cement  and  lime  workers,  7  radio  factory



workers using a photostatic procedure,  4 metal factory  workers,  4 painters and



polishers,  3 fur workers, and 6 others.



     Engebrigsten (1952) reported  eight cases of cement eczema among 300 to 400



Norwegian workers exposed "more or less directly" to cement dust that contained



0.002 to 0.020$ water-soluble  Cr(VI),  which was described only as "water-soluble



chromates."  Positive patch testing was reported in  7 of  8 patients exposed to



0.5$ aqueous  solution  of potassium dichromate.   Positive reactions to cement



patch tests were  observed in 4 of 8 patients.  Of  the 10  persons who served as



controls, none  gave  any positive reactions.  Engebrigtsen (1952) subsequently
                                      7-6

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tested the same eight patients with a cement  slurry  that had been washed  free of




Cr(VI), and none of the people reacted positively.




     Denton et al. (1954) patch tested a patient with a "strong specific hyper-




sensitivity to potassium chromate" with three solutions:  (1) a 50 ppm solution




of potassium dichromate,  (2)  1 ppm water-soluble  Cr(VI)  filtrate  from American




Portland  cement,   and  (3) 4 ppm  water-soluble Cr(VI)  filtrate  from American




Portland cement.   Each  patch test resulted  in  an  erythematous,  edematous, and




papulovesicular reaction.  There was no reaction to distilled water and none of




the control subjects reacted to any of the three Cr(VI) solutions.




     Six out of 200 employees who worked in a diesel locomotive repair shop were




incapacitated by chromate dermatitis  (Winston and Walsh, 1951).  All were exposed




to an  alkaline diesel  locomotive radiator  fluid  that contained  0.08$  sodium




dichromate.   Positive patch  testing was  reported  for both  sodium  dichromate




(pH 4.25) and the radiator fluid (pH 10).




     Walsh (1953), in a summary report on chromate hazards  in industry, described




the following patch test  results:   2% "chromate acid" applied  for 24 hours on




superficial skin  abrasions  produced a  crusted  lesion in 3 weeks;  0.5$  sodium




dichromate, reapplied daily  for  3 days, produced a crusted  lesion in 3 weeks;




0.5$ potassium  chromate, applied  8  hours/day for 3 days, produced  lesions in




3 days; 0.5$ sodium chromate, 0.005$  sodium  dichromate, and  pure  zinc chromate



also produced lesions in 3 days after being in contact with skin for 8 hours/day




for 3 days.  Lead  chromate did not produce a reaction after  the  same exposure




period.  A 10$  solution  of Cr(III) nitrate produced redness after the solution




was reapplied daily for 3 days.




     Edmundson (1951)  obtained only two  positive reactions with patch testing in




56 men who had  chrome  ulcers.  All men  were said to have a  history  of chrome




dermatitis.  He concluded that the presence of chrome ulcers did not necessarily




indicate sensitization.






                                      7-7

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     Other investigators (Morris, 1955; McCord et al.,  1931;  Levin  et  al.,  1959)



have demonstrated sensitization to other chromium compounds  in workers employed



as  tanners  and lithographers.   Many of the  workers gave positive results for



patch tests.




     There have been numerous case reports of contact dermatitis resulting from



exposure  to  a variety of chromium-containing products,  such as  matches, auto-



mobile  primer paint,  and  fumes  from welding  rods  (Fregert, 1961;  Engle and



Calnan, 1963; Newhouse, 1963; Fregert and Ovrum, 1963;  Shelley, 1961).  In most



of these reports,  the subjects developed a positive reaction to patch testing for



a solution of potassium dichromate.




     A study conducted in France by Jaeger and Pelloni (1950) demonstrated that



workers with  cement  eczema  were sensitive  to potassium dichromate.   In their



study, the authors patch tested 32 patients with cement eczema and 168 patients



with eczema  from  other causes.   Those with  cement eczema gave  positive patch



tests (94$) to an  aqueous 0.5$ solution of potassium dichromate, while  only 5$ of



the other eczema patients exhibited positive reactions from the dichromate.



     However,  Perone  et al.   (197*0  reported that  only  2  of 95  construction



workers who  regularly worked with cement gave a positive  reaction  to  patch



testing to  a solution of 0.25$  potassium dichromate or  a  solution  containing



M50 ng/g Cr(VI) extracted from  cement.   The authors suggested that  the  cement



dermatitis present in  the construction workers  was  associated with the initia-



tive nature of the cement rather than a hypersensitivity.




     There have been  two  reported  cases of eczema  in men who regularly  worked



with cement and who each had a green tattoo which contained chromium (Cairns and



Calnan, 1962; Loewenthal,  1960).  Both men developed a positive reaction to patch



testing to a solution  of potassium dichromate  (concentration range:  0.1 to 2$).



Negative results  following patch testing were  observed  when  the  solution  was
                                      7-8

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Cr(III) sulfate.  The green pigment in one  of the tatoos contained Cr(VI), but



the oxidation state of chromium in the other tattoo was not determined.



     Krishna  et al.  (1976)  reported  that  chrome workers  exposed to  0.21  to



0.80 mg/m3  Cr(VI)  displayed  various  dermatologic  disorders,   including  skin



ulcers, dermatitis,  and  nasal perforations.  Dermatologic  irritation has been



reported by  Clausen  and  Rastogi (1977),  in  auto  workshop employees exposed to



0.01 to 3.75 pg/m3; by Tandon et al.  (1977), in  electroplaters, polishers, and



pigment workers;  and by  Spruit  and  Martin (1975), in offset printing employees



who came in  contact  with materials (usually  inks)  containing  up to  60,000 ppra



chromium.  Peltonen  and  Fraki (1983)  found  that in a population of 822 healthy




volunteers,  2%  of 410  men and  1.5$ of  412  women showed  a  patch-positive test



reaction to  0.5$ K?Cr,,07 solution.  Most  of  the  reactions  occurred  among workers




in the printing industry.



     Various  dermatologic  disorders among workers exposed to 0.001 to 0.020 mg



Cr/m   in  air and  chromium on  work  surfaces have  been reported  by  Lucas and



Kramkowski  (1975).   Chromium-induced dermatitis  or  eczema  has been  associated



with workers having contact with various  chromium-containing lubricants and oils



(Rosensteel  and Lucas,  1975;  Weisenberger, 1976; Clausen  and  Rastogi, 1977).



Dermatitis associated  with various chromium pigments and  coloring  agents has



been described  by Somov et al.   (1976),  Fisher (1977), Fregert and  Gruvberger



(1976), Venediktova and  Gudina  (1976), and  Evans  (1977a,b,c).



     Allergic sensitization  to  chromium-containing compounds has been reported



by Burry  and Kirk (1975)  in  several  industrially exposed  individuals,  and by



Wahlberg and  Wennersten  (1977)  and  Kaaber and Deien  (1977), who used potassium



dichromate  in  the  patch  tests.   Husain  (1977)  showed  sensitization  in the



"general  population" (not occupationally exposed),  where,  among  1312 patients



tested, 11.58$  had contact sensitivity to 0.5$  potassium dichromate  in a patch
                                      7-9

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test (15.59? of the  males reacted to the chromate as opposed to 8.18$ of females




tested).




     Perisic and Jovovic (1977) have identified allergic contact sensitivity to




chromates among 219 Yugoslavian housewives.   The  incidence of allergic contact




sensitivity was confirmed in  H3 cases  (19.62?); the percentage of positive cases




was 31-M? in women holding  permanent  jobs,  23.51$ in cleaners, and  14.58? in




unemployed housewives.  It  was  concluded by the authors that chromates contained




in a variety of household products used in routine  cleaning operations are the




cause of  allergic sensitivity  to  chromates in women.   No  control  or reference




data were available.




     Jovovic et al.  (1977)  have confirmed the allergic  contact  sensitivity of




shoemakers exposed to chromates in occupational settings.  Sixty percent of the




shoemakers with  allergic  sensitivity  showed  a positive reaction  to  potassium




dichromate.  Allergic reactions in  various glues to which  the  shoemakers were




exposed were also reported.




     Exposure  to  chromium  may  sensitize  certain  individuals  resulting  in




asthmatic attacks upon subsequent re-exposure  (NAS, 1974)  (see Section 7.2.5.1).








     7.1.3.2.  SENSITIVITY TO  CHROMIUM IN  PROSTHESES —  In recent  years, there




has been  an  increase  in the use  of metal-to-plastic prostheses in orthopedic




surgery.   Many  of the  metal  implants  consist  of  alloys  containing nickel,




chromium, cobalt, and molybdenum.




     Work by Swanson et al. (1973) and Coleman et  al. (1973)  has shown  that when




two cobalt/chrome alloy  surfaces  rub together, cobalt  and  chrome  are released




locally,  pass into the blood  and circulate throughout the tissue of  the  body, and




are finally excreted  in the urine.  In patients sensitive to metal, the vessels




supplying the  bone  in which  the  prosthesis  is  inserted may show obliterative
                                      7-10

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changes, and in theory, lead to death of the bone, with weakening of the fixation




between the bone and prostheses, and consequent loosening (Anonymous, 1976).




     There is considerable conflicting evidence in this area, as Deutman et al.




(1977)  reported  metal  sensitivity in  4  of 66 patients  induced by  metal alloy




implants following total hip  replacement  arthroplasty;  however,  positive patch




tests  occurred  only with  cobalt  and  nickel, while  tests with  chromium were




negative.  Brown et al. (1977)  gave  patch tests  for chromium sensitivity to 20




patients with sterile  loose hip replacements.   Of these 20 patients, none were




positive for chromium  sensitivity, and of 17  patients  that were reoperated on,




none showed histologic evidence of delayed hypersensitivity around the implant.




     In  addition,  contact  dermatitis and allergic  sensitivity  to  chromium-




containing  dental  prostheses  have  been  reported by  Levantine  (197*0  and




Ovrutskii  (1976).








     7.1.3.3.  ANIMAL STUDIES ON CHROMIUM  SENSITIVITY ~ Numerous investigators




have demonstrated  that sensitization of laboratory animals  can be  produced by




exposure to various chromium compounds, including both Cr(VI) and (III).




     In  studies  of delayed  dermal hypersensitivity  to  potassium  chromate or




chromium  chloride,  guinea  pigs  treated  with  2.4 x  10"   M chromic  sulfate




developed signifiant cross  sections (Gross  et al., 1968). The  ability of Cr(III)



compounds  to evoke  an  allergic  reaction in  chromium-sensitive  guinea  pigs




decreased gradually in  the  following order:  chromic chloride  > chromic nitrate >




chromic sulfate  >  chromic  acetate  > chromic oxalate (Scheiner and Katz, 1973).




According to the authors, this difference depended on the  free  Cr(III) concentra-




tion in the solution which, in turn, depended  on  the degree to which the Cr(III)




formed  coordination complexes with the original ligands present; strong ligands




prevented the formation of complete antigens.   Sensitization  of guinea pigs with
                                      7-11

-------
chromium (III) sulfate (using  Triton X-100) was 86$ successful, whereas sensiti-



zation with an aqueous solution of potassium chromate was successful in only 56?



of the animals tested (Schwartz-Speck and Grundsmann, 1972).



     Jansen and Berrens (1968) reported that guinea pigs could be sensitized to



both Cr(III) and Cr(VI)  by the subcutaneous injection of aqueous solutions of the



appropriate chromium salts in a 1:1  emulsion with Freund's complete adjuvant.



     Hicks  et al.  (1979)  produced  hypersensitization in guinea  pigs  with both



Cr(VI) and  (III)  salts.   The contact  sensitization potentials  of  the  Cr(III)



complexes in guinea pigs were proportional to  the release of chromium from the



complex (Schneeberger and Forck, 1971*).   Siegenthaler  et  al.  (1983) found that



guinea  pigs sensitized with  either trivalent  chromium chloride  or  potassium



dichromate  reacted in vitro  and  in vivo  to  challenges with both salts.   They



concluded  that  chromium-reactive lymphocytes  are directed  against  common  or



closely related determinants.
                                      7-12

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7.2.  EVALUATION OF THE CARCINOGENICITY OF CHROMIUM




     The purpose of this section is to provide an evaluation of the likelihood




that chromium is a human carcinogen and, on the assumption that it is a human




carcinogen, to provide a basis for estimating its public health impact, including




a potency evaluation in relation to other carcinogens.  The evaluation of




carcinogenicity depends heavily on animal bioassays and epidemiologic evidence.




However, other factors, including mutagenicity, metabolism (particularly in




relation to interaction with DNA), and pharmacokinetic behavior, have an important




bearing on both the qualitative and the quantitative assessment of carcinogenicity.




The available information on these subjects is reviewed in other sections of




this document.  This section presents an evaluation of the animal bioassays,




the human epidemiologic evidence, the quantitative aspects of assessment, and




finally, a summary and conclusions dealing with all of the relevant aspects of




the carcinogenicity of chromium.






7.2.1.  Animal Studies.  A number of animal studies have been performed to




determine whether or not chromium compounds are carcinogenic.  In these studies




metallic chromium and salts of both the hexavalent (Cr VI) and trivalent (Cr III)




states were administered by various routes.  The discussions that follow are




grouped according to these various routes of administration.






     7.2.1.1.  INHALATION STUDIES — Baetjer et al. (1959) exposed three strains




of mice (strain A, Swiss,  and C57BL) to chromium-containing dust.   These strains




have,'respectively, high,  medium, and low spontaneous lung tumor incidences.




The dust was similar to that found in the chromium chemical manufacturing




industry,  containing 13.7% hexavalent chromium oxide (Cr03) and 6.9% trivalent




chromium oxide (0^03), along with other metal oxides.   In addition to the




chromium compounds in the  dust,  potassium dichromate (K^C^Oy)  was added at a






                                      7-13

-------
level of 1.0%.  The animals were exposed to the dust-laden atmosphere containing

between 0.5 and 1 mg of total chromium 4 hours/day,  5 days/week,  for an average

of 39.7 weeks (range of 16 to 58 weeks).  Table 7-1  describes the specifics for

each exposure group.  At death or termination of exposure,  the lungs were

examined by means of a low-power microscope,  and abnormal tissues were submitted

for histologic confirmation of tumors.
      TABLE 7-1.  INHALATION EXPOSURE OF MICE TO CHROMIUM-CONTAINING DUST
                             (Baetjer et al.  1959)
Strain
Swiss
Swiss
Swiss
Strain A
Strain A
Strain A
Strain A
C57BL
C57BL
Sex
F
M
F
F
F
F
M
M
F
Number of
animals at
start
11
10
127
34
45
110
52
50
61
Number of
animals at
end
7
6
51
31
45
38
36
13
14
Duration of
exposure
(weeks)
39
39
58
16
24
38
46
42
41
Estimate
of total
Cr inhaled
(mg of Cr)
520
520
692
141
210
359
406
667
589
     The incidence of lung tumors was not different in exposed mice of any

strain as compared with approximately equal numbers of the appropriate strains

of unexposed mice of the same age.  There was also no difference in those

strains having high spontaneous tumor incidence with regard to the average number


                                      7-14

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of tumors per mouse or the percent of mice with multiple tumors.  The lung




tumors present in both control and treated animals were adenomas, which appeared




to be histologically similar; however, in exposed animals, the adenomas developed




slightly earlier in the strain A mice.  Three additional small groups of mice




(two groups of 10 Swiss female mice and one group of nine female strain A mice)




were exposed to high concentrations of chromium dust (7.8 to 13 rag Cr/m-*) in




a nose-only chamber 0.5 hours/day, 5 days/week, for 43, 52, and 20 weeks,




respectively.  Again, no increase in the incidence of lung tumors was observed.




     In a lifetime chronic study, Nettesheim et al. (1971) exposed 136 C57BL/6




mice of each sex 5 hours/day, 5 days/week, to an atmosphere containing calcium




chromate (CaCrO,) dust at a level of 13 mg/m ,  with 95% of the particles less




than 0.6 microns in size.  During the study, seven or eight mice were removed for




interim sacrifice at 6, 12, and 18 months; the sex distribution and exact number




of animals removed at each period were not stated.  At autopsy, sections were




taken from all major organs, and with the exception of the lungs, it was




indicated that no increase in tumor incidence was observed.  In the lungs,




tumors developed in six males and eight females, as compared with three males




and two females in the control group.  The tumors were described as alveologenic




adenomas and adenocarcinomas, although the numbers of the different types of




tumors were not given.  The authors claim in the discussion that calcium chromate




exposure resulted in a significant increase in lung tumors; however, the




performance of statistical analysis was not described in the results.  In a




review of this study, the International Agency for Research on Cancer (IARC




1980) maintained that no excess in treatment-related tumors was observed.




Because of difficulties in determining the numbers and sexes of the animals removed




during the interim kills, it is impossible to perform independent statistical




analysis of these data.







                                      7-15

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     Two other experimental groups in the aforementioned study were exposed to




calcium chromate dust following prior treatment with 100 R whole-body X-radiation




or infection by influenza virus.  A slightly greater incidence of lung*tumors




was observed after combined exposure to influenza virus, as compared with




exposure to calcium chromate alone.  As a result of exposure to two potential




cancer-producing agents, these last two groups of animals cannot be used to




provide any supporting evidence for the carcinogenicity of calcium chromate.




With the limited experimental detail presented in this study, it is not possible




to determine if the small increase in lung tumors represents a significant




treatment-related increase in tumor incidence.




     In the study described previously, Baetjer et al. (1959) also exposed 110




(57 males and 53 females) mixed-strain rats (from Wistar and McCollum stock) to




the same chromium dust to which the mice were exposed; 100 rats (48 males and




52 females) of similar age distribution were kept as controls.  The level of




chromium in the air was 1 to 1.5 mg/m^, with exposure again for 4 hours/day, 5




days/week, for >70 weeks.  During the study, nearly half of the experimental




rats died, three developed lymphosarcomas involving the lungs, while two




additional suspected lymphpsarcomas involving the lungs were also identified.




No rats developed bronchogenic carcinomas.  The authors considered these findings




suggestive of a chromium-induced tumorigenic response; however,  since lymphosarcomas




are common in these rats, the experiment was repeated.  In the second study




(Steffee and Baetjer 1965), Wistar rats were exposed to chromium-containing




dust under the same regime as described previously.  Following autopsy,  three




alveogenic adenomas were detected in the treated rats and two in the controls,




and four lymphosarcomas were present in both groups.  From this second study,




it was concluded that J.ymphosarcomas in rats are not associated with exposure




to chromiura-cpntaining dust.






                                      7-16

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      Also,  Steffee  and  Baetjer (1965)  exposed  eight  rabbits  and  50  guinea pigs



 to mixed  chromium dust  containing  1.5  to  2.0 mg  of total  chromium/m3  for 4  to



 5  hours/day,  4  days/week,  for 50 months and  for  life,  respectively.   The mixed
                                                                      •»


 chromium  dust exposure  consisted of  2  days/week  exposure  to  roast dust,  as



 described by  Baetjer et al.  (1959),  supplemented with  1.0% dry potassium



 dichromate and  the  mist of a 5.0%  solution of  potassium dichromate,  followed



 by a  1  day/week exposure to  the mist of a 17.5%  solution  of  sodium  chromate



 and a 1 day/week exposure  to residue dust (roast dust  from which sodium  chromate



 was extracted)  supplemented  with 1.0%  dry potassium  dichromate.  .There were no



 lung  tumors in  the  rabbits,  and the  incidence  of lung  tumors  and other body



 tumors  was  similar  in the  exposed  and  control  guinea pigs.   Under these  experi-



 mental  conditions,  inhalation of mixed chromium  dust did  not  increase  the



 incidence of  lung tumors.



      Laskin (1972)  conducted a study in which  rats (number and strain not



 specified) were exposed  by inhalation  to  air containing 2 mg/m3 hexavalent



 calcium chromate.   The  total number  of exposures  was 589  over a period of 891



 days.   The author reported one squamous cell carcinoma of the lung and larnyx



 and one malignant peritoneal tumor.  Because of  incomplete reporting of the



 experiment, this  study  is  considered to be inadequate to assess the carcino-



 genicity  of calcium  chromate  by  inhalation.



      7.2.1.2.    INTRATRACHEAL INSTILLATION STUDIES — In further attempts to



 illustrate a  lung tumorigenic  response from chromium compounds,  mixed chromium



 dust  and  chromium salts were  instilled into the tracheas  of experimental animals.



 Baetjer et al.  (1959) suspended a chromium dust,  similar  in composition to



 that used in the inhalation  studies,  in olive oil, and  zinc chromate and barium



 chromate in saline prior to  intratracheal  instillation  into strain  A,  Swiss,



and C57BL mice and mixed-breed rats (Wistar and McCollum  stocks).   The mice



each received  five to six instillations of 0.01 to 0.05 mg of chromium at 4- to



                                      7-17

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6-week intervals,  while the rats received 15 instillations at the same dose at




2-week intervals.   The total duration of the studies was between 32 and 52 weeks.




The mice treated with chromium had a tumor incidence similar to age-matched




controls, and the  rats in both the treated and control groups had no benign or




malignant tumors.   In continuing work,  Steffee and Baetjer (1965) treated 62




strain A mice with 0.01 to 0.03 mg chromium by intratracheal instillation of




zinc chromate (ZnCrC^).  The instillations were performed at 2-week intervals




for a total of six injections, and the animals were observed until death.  The




incidence of lung adenomas was 31 of 62 in the treated animals and 7 of 18 in




the untreated controls.  In the controls treated with zinc chromate, 3 of 12




animals developed lung adenomas.  The incidence of lung tumors in treated




animals was statistically different from controls.  In the same, study, the




instillation of chromium dust, zinc chromate, and lead, ch.ro.mate (PbCrC>4) into




the tracheas of guinea pigs (13 to 21 animals/group) and rabbits (7 to 10




animals/group) produced no increase in lung adenomas.  Hueper and Payne (1962)




also reported similar negative results after instillation of stro,n.tium chromate




(SrCrO^) or calcium chromate suspended in gelatin; however, the experimental




detail  in the report was insufficient for adequate evaluation.  There is no




convincing evidence that intratracheal instillation of chromium compounds




results  in the development of  lung cancer.




     Steinhoff et al.  (1983 unpublished draft report) investigated the carcino-




genicity of  soluble sodium dichromate and calcium chromate in r^ts via intra-




trachael administration.  The  study consisted of 10 treatment groups, one negative




control group, and two positive  control groups.  Each test group contained 40 male




and 40  female  Sprague-Dawley  rats  (10 weeks  old at  the beginning of the test).




The design of  the dose levels  selected were  such as  to assess the  impacts, of  the




chemicals  delivered  in single  high doses  as  contrasted  to  the same  dose  distri-




buted  over a 5-day period.   Table  7-2 describes  the  dose levels  used  in  this  study.




                                       7-18

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           TABLE 7-2.  DOSAGE REGIMEN FOR INTRATRACHEAL INSTILLATION
                   OF SODIUM DICHROMATE AND CALCIUM CHROMATE
                      (adapted from Steinhoff et al. 1983)
                                         Intratracheal instillation
Test group3                   1 time per week               5 times per week
Untreated                           —                              —

Physiological NaCl                5 mL/kg                        1 mL/kg

Na2Cr207 * 21^0                 0.05 mg/kg                      0.01 mg/kg

Na2Cr207 * 21^0                 0.25 mg/kg                      0.05 mg/kg

Na2Cr207 * 21^0                 1.25 mg/kg                      0.25 mg/kg

                                1.25 mg/kg                      0.25 mg/kg
aEach group consisted of 40 male and 40 female Sprague-Dawley rats.



     The study was conducted for 2 years and 8 months.  The total dose administered

for the highest dose group was 160 mg/kg.   The dose levels of 5 x 0.25 mg/kg/week

of sodium dichromate as well as calcium chromate were considered to be maximum

tolerated doses.  The maximum tolerated dose was demonstrated by the decline in

the body weight gain and the increases in  the absolute and relative lung weights;

however, the decline in body weights was more pronounced in males than in females.

     Rats administered sodium dichromate or calcium chromate one or five times

per week had no significant reduction in survival periods as compared to controls,

except in the case of females treated with calcium chromate 5 x 0.25 mg/kg

week (P <^0.05 for saline controls and P <^0.01 for untreated controls).

     The distribution of lung tumors (adenomas, adenocarcinomas, and squamous

cell carcinomas) is presented in Table 7-3.  An increased incidence of lung tumors

as compared to controls was observed in only one treated group in which sodium

dichromate was administered at 1 x 1.25 mg/kg/week.  No lung tumors were observed

in any of the groups treated with 5 x 0.01, 5 x 0.05,  or 5 x 0.25 mg/kg/week,


                                      7-19

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TABLE 7-3.  LUNG TUMOR INCIDENCE IN SPRAGUE-DAWLEY RATS FOLLOWING INTRATRACHEAL
             INSTILLATION OF SODIUM DICHROMATE OR CALCIUM CHROMATE
                            (Steinhoff et al. 1983)
                                             Lung tumor incidence
                                                     Adeno-      Squamous cell
                                    Adenomas       carcinomas      carcinomas
    Treatment group

Untreated
Physiological NaCl 5x/wk
Physiological NaCl Ix/wk
Na2Cr207 * 21^0 5x0.01 mg/kg/wk
Na2Cr207 * 21^0 5x0.05 mg/kg/wk
Na2Cr207 * 21^0 5x0.25 mg/kg/wk
Na2Cr20? * 21^0 1x0.05 mg/kg/wk
Na2Cr20? ' 2H20 1x0.25 mg/kg/wk
Na2Cr20? * 2H20 1x1.25 mg/kg/wk
CaCrO^ 1x1.25 mg/kg/wk
CaCr04 5x0.25 mg/kg/wk
M
0/40
0/40
0/40
0/40
0/40
0/40
0/40
1/40
6/40a
9/40
5/40
F
0/40
0/40
0/40
0/40
0/40
0/40
0/40
0/40
6/40
2/40
0/40
M
0/40
0/40
0/40
0/40
0/40
0/40
0/40
0/40
2/40
1/40
0/40
F
0/40
0/40
0/40
0/40
0/40
0/40
0/40
0/40
0/40
0/40
0/40
M
0/40
0/40
0/40
•0/40
0/40
0/40
0/40
0/40
3/40
l/40b
0/40
F
0/40
0/40
0/40
0/40
0/40
0/40
0/40
0/40
3/40a
1/40
1/40
alncluded two tumors of doubtful origin.  These were, in the first case
 (female rat), a squamous cell carcinoma, and in the second case (male rat),
 an adenocarcinoma in the paratracheal lymph nodes,  probably metastases of
 tumors of unknown origin.
^Included a squamous cell carcinoma of the lung (male rat).  It is not certain
 whether this was a primary lung tumor or a metastasis of a histologically
 proven squamous cell carcinoma of the jaw.
with the exception of one adenoma in a male rat treated with sodium dichromate

(1 x 1.25 mg/kg/week).   In rats administered calcium chromate,  statistically

significant increases in lung tumors were found in groups treated with 1  x 1.25

rag/kg/week, as well as  in a group treated with 5 x 0.25 mg/kg/week distributed

over a -period of 5 days.  Table 7-4 gives a retabulation of the results presented

in Table 7-3, in which  adenomas and adenocarcinomas were combined.  The combined

lung tumor incidence was statistically significant in male and  female rats

treated with 1 x 1.25 mg/kg/week of sodium dichromate.   For calcium chromate,

the combined adenomas and carcinomas were statistically significant only  in male


                                      7-20

-------
   TABLE 7-4.   COMBINED LUNG TUMOR INCIDENCE  IN SPRAGUE-DAWLEY  RATS FOLLOWING
     INTRATRACHAEL INSTILLATION OF SODIUM DICHROMATE  AND CALCIUM DICHROMATE
                            (Steinhoff et al.  1983)
Lung tumor incidence
Treatment group
Untreated
Physiological NaCl 5x/wk
Physiological NaCl Ix/wk
Na2Cr207 ' 2H20 1x0.25 mg/kg/wk
Na2Cr20? ' 2H20 1x1.25 mg/kg/wk
CaCrO^ 1x1.25 mg/kg/wk
CaCr04 5x0.25 mg/kg/wk
Adenomas and
Adenocarcinomas
Male
0/40
0/40
0/40
1/40
8/40a
P=0,003b
10/40
P=0.0005b
5/40
P=0.027b
Female
0/40
0/40
0/40
0/40
6/40
P=0.013b
2/40
0/40
Squamous cell
carcinomas
Male
0/40
0/40
0/40
0/40
3/40
1/40C
0/40
Female
0/40
0/40
0/40
0/40
3/40
1/40
1/40
alncluded two tumors of doubtful origin.   These were,  in the first case (female
 rat), a squamous cell carcinoma, and in the second case (male rat),  an
 adenocarcinoma in the paratracheal lymph nodes,  probably metastases  of tumors
 of unknown origin.
bP-values calculated using the Fisher Exact Test.
clncluded squamous cell carcinoma of the  lung (male rat).  It is uncertain
 whether this was a primary lung tumor.
rats treated with single weekly doses of 1.25 mg/kg/week,  as well as with the

same dose distributed over a period of 5 days (5 x 0.25 mg/kg).   The adequacy

of this study is validated by the carcinogenic effect of the positive controls

dimethylcarbamylchloride and benzo[a]pyrene.

     In conclusion,  sodium dichromate and calcium chromate administered

intratracheally in solution form in Sprague-Dawley rats resulted in positive

carcinogenic effects.
                                      7-21

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     7.2.1.3.  INTRABRONCHIAL IMPLANTATION STUDIES — Laskin et al.  (1970)

investigated the carcinogenic effects  of chromium compounds  using the intra-

bronchial pellet technique.   The compounds used  in this  investigation were:

chromic chromate,  chromic oxide, chromic trioxide,  calcium chromate,  and process

residue.  Pellets were prepared from molten mixtures  of  materials dispersed  in

equal quantities of cholesterol carrier.  These  studies  included material of

differing solubilities and valences.  A total  of 500  rats  were under  observation

for periods of up to 136 weeks.  Lung  cancers  that closely duplicate  human

pathology were found in these studies  (Table 7-5).
        TABLE 7-5.   CARCINOMAS PRODUCED WITH CHROMIUM COMPOUNDS IN RATS
                              (Laskin et al. 1970)
Material
Process residue
Calcium chromate
Chromic chromate
Chromic oxide
Chromic trioxide
Cholesterol control
Number of Squamous cell
animals carcinoma
100 1
100 6
100
98
100
24
Adeno- Heptocellular
carcinoma carcinoma
_ i
2 1
1
-
2
-
     With the calcium chromate,  eight cancers  were found in an exposed group of

100 animals.  Six of these were  squamous cell  carcinomas and the other two were

adenocarcinomas.

     The National Institute for  Occupational Safety and Health (NIOSH 1975)

criteria document on hexavalent  chromium (Cr VI) described a written communica-


                                      7-22

-------
tion from L.S. Levy in 1975 about an animal study done at the Chester Beatty




Research Institute, London.  Random-bred Parton Wistar rats of both sexes




received a pellet in the left inferior bronchiolus via trachectomy under




anesthesia.  The rats were kept for 2 years.  One hundred rats were set up for




each of the chromium-containing-material test groups.  The pellets that were




implanted contained 2 mg of test material suspended 50/50 (w/w) in cholesterol.




Negative control groups received either blank metal pellets or pellets and vehicle.




Positive control groups received 3-methylcholanthrene.  The lungs of all rats




either dying during the study or killed at its termination were examined both




macroscopically and microscopically.  Apart from those in the lung, tumors were




similar both in type and number in all groups.  The bronchial tumors found and




microscopically confirmed are given in Table 7-6,  along with the average induction




periods.  Additional lung tumors not of bronchial origin and not considered by




the authors to be causally related to implantations are also listed in Table




7-6.  The majority of bronchial tumors were large keratinizing squamous cell




carcinomas.  Intrathoracic invasions, particularly to the right lung in the




hilar region,  were common, and metastases to local lymph nodes and to kidneys




were seen.




     Squamous cell carcinomas were found in 8/100  (P < 0.05)  rats receiving




calcium chromate,  3/100 rats receiving zinc chromate (zinc potassium chromate),




3/100 rats  receiving chromic chromate dispersed  in silica, and 1/100 rats




receiving ground chromic acid.   It may be that the chromic acid implantation




produced a  carcinoma only because  it was converted to a less-soluble hexavalent




chromium material  by reaction with cholesterol.   Because of  its extremely  great




oxidizing ability,  some of the chromic acid may  have been chemically reduced by




cholesterol,  forming chromic chromate.   Calcium  chromate produced carcinomas in




5/100 (P <  0.05) rats  when mixed with primene, and carcinomas  in 7/100  (P  <




0.05) rats  when mixed  with diphenylguanidine.   Primene 81-R benzoate and







                                      7-23

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         TABLE 7-6.  LIVING TUMORS FOUND AND MICROSCOPICALLY CONFIRMED
                     [Levy and Venitt (1975), NIOSH (1975)]
Experi-
mental
group
no.
         Cora-
         pound
         no.    Test material
No. of
rats
in
group
Bronchial
carcinoma
of left
lung
Induction
period
in days
(range)
Lung tumors
not associated
with treatment
                Ground chro-
                mite ore

                Bolton high
                lime residue

                Residue after
                alumina pre-
                cipitation

                Residue from
                slurry tank-
                free of
                soluble Cr

                Residue from
                vanadium
                filter

                Residue from
                slurry
                disposal tank
                Sodium dichro-
                mate dihydrate
                                  100
                                   it
                                   it
                                  101
                                  100
                                                                   Pulmonary aden-
                                                                   oma of left lung
                                 Anaplastic car-
                                 cinoma of upper
                                 left lung

                                 Adenoma of
                                 right lung

                                 Fibrosarcoma of
                                 upper left lung
8
9

10
11
12

8
9

10
11
12

Sodium chromate "
Chromic acid "
(ground)
Chromic oxide "
Calcium chromate "
Chromic chloride "
hexahydrate
it
1

0
8
0


560

—
604(473-474) P < 0.05a
Lymphoma of
— right lung
*P-value is calculated using the
 Fisher Exact Test (one-tailed).
    c potassium chromate.
                                                  (continued on the following page)
                                      7-24

-------
                                     TABLE 7-6.  (continued)
Experi-
mental
group
no.
13
14
21
22
23

24

25
26
Com-
pound
no.
13
14
15A
15B
16A

16B

17A
17B
No. of
rats
in
Test material group
Zinc chr ornate "
type IIb
Chrome tan "
Diphenyl- "
guanidine (DPG)
DPG + calcium "
Primene 81 -R 100
benzoate
Primene + cal- "
cium chr ornate
Chromic chromate "
Chromic chromate "
Bronchial
carcinoma
of left
lung
3
0
it
7
0

5

0
3
Induction
period
in days
(range)
708(657-734)
—
—
656(502-732)
—

620(440-732)

—
698(666-730)
Lung tumors
not^ associated
with treatment



P < 0.05a


P < 0.05a



                dispersed in
                silica
15
16
28
20
17
18
19
27
15
16
28
20
17
-18
19
27
Pellet + chol- 150
esterol
Blank pellet "
Pellet + chol- 100
esterol +
Kieselguhr
100% 3 -MCA 48
100% 3 -MCA "
50% 3 -MCA "
25% 3 -MCA
50% 3 -MCA 50
0
ii

34
36
18
13
36

—
•"• *™
493(217-730)
498(270-701)
474(284-696)
517(297-698)
498(269-732)
Adenoma of
right lung
Adenocarcinom,
of right lung






aP-value is calculated using the
 Fisher Exact Test (one-tailed)
"Zinc potassium chromate.
                                         7-25

-------
      •Iguanidine failed to produce  tumors  when administered by themselves.   No




      i.al carcinomas were found in negative control  groups or in rats receiving




sodium dichromate dihydrate or sodium chromate.




     Levy and Martin (1983) conducted an extensive  investigation of 21 chromium-




containing test materials in Wistar  rats, using an  intrabronchial implantation




technique.  In this procedure, a stainless  steel wire mesh pallet with anchoring




hooks was loaded with approximately  2 mg of test material suspended in 2 mg of




cholesterol as an inert carrier, and was surgically  implanted into the lower




left bronchus of 8-week-old rats. The study comprised 21 test groups, one




vehicle-control group, and another positive control  group.  Details of the




study design are given in Table 7-7.  Weight gain and survival rate between the




test and control groups showed a compound related effect.  The rats were allowed




to live for 2 years, after which the study  was terminated.  As shown in Table




7-7, an examination of the lung tissues indicated that bronchial carcinomas




were found to be statistically significant  in comparison with controls only in




the groups given strontium chromate, zinc chromate,  and calcium chronmte.  The




authors of this  study concluded that the carcinogenicity of chrom,iu,m compounds
depends on the extent of their solubility.  Only sparingly soluble chromium




compounds were observed to be carcinogenic.






      7.2.1.4.  INTRAPLEURAL INJECTION STUDIES — Production of pulmonary




tumors by the intrapleural injection of chromium compounds has also been




attempted.  Hueper and Payne  (Hueper 1955, Hueper 1958, Payne 1960a, Hueper




1961, Hueper  and Payne 1962)  described a  series of studies in rats Created, by




intrapleural  injection of a number  of hexavalent or trivalent chromium com-




pounds.   Hueper  (1955) injected powdered  metallic chromium into  the pleural




cavity  of rats,  guinea pigs,  and mice under the dose  schedule described  in




Table 7-8.   No  significant  increase in tumor  incidence, either at  the  injection




                                      7-26

-------
           TABLE 7-7.  INCIDENCE OF LUNG TUMORS IN RATS FOLLOWING INTRABRONCHIAL IMPLANTATION
                                     OF VARIOUS CHROMIUM COMPOUNDS
                                  (adapted from Levy and Martin 1983)
Group
no.
1
2

3

4
5

6

^j 7
1
N)
*"J 8

9

10

11

12
13

14

15

Test material
Lead chromate
Primrose chrome
yellow
Strontium
chromate
Barium chromate
Molybdate
chromate orange
Zinc chromate
(low sol. )
Zinc
tetroxychromate

Cholesterol
(negative control)
Light chrome
yellow
LD chrome
yellow
Calcium chromate
(positive control)
Chromic acid
Medium chrome
yellow
Zinc chromate
(Norge)
Sodium
dichromate
No.
of
rats3
100
100.

100

101
100

100

100


100

100

100

100

too
100

100

100

No. of lungs
examined
98
100

99

101
100

100

100


100

100

100

100

100
100

100

99

No. of bronchial
carcinomas Probability Significance
1 0.2 - 0.15 NSt>
1 0.2-0.15 NS

43 <0. 00005 sc

0 - -
0 - -

5 0.015-0.010 S

1 0.2 - 0.15 NS


0 - -

0 - -

1 0.2 - 0.15 NS

25 <0. 00005 S

2 0.08 - 0.07 NS
1 0.2-0.15 NS

3 0.05-0.04 S

1 0.15-0.10 NS

Valence of
chromium
6
6

6

6
6

6

6




6

6

6

6
6

6

6

aFor groups 1-22, 52 females  and  48 males  were  used.   For group 23,  24 females  and 24 males were used.
bNS -  Not statistically significant.
CS = Statistically significant  at the  5Z level.
                                                                                      (continued on the following page)

-------
                                                       TABLE 7-7. (continued)
i
NJ
00
Group
no.
16

17

18

19

20

21


22

23


Test material
High lime
residue
Vanadium
solids
High silica
chrome ore
Kiln frit
(2% limestone)
Recycled residue
(2% limestone)
Silica encaps.
medium chrome
yellow
Strontium
chromate
20-methyl-
cholanthrene
(positive control)
No.
of
rats
100

100

101

100

100

100


100

48


No. of lungs No. of bronchial Valence of
examined carcinomas Probability Significance chromium
99 1 0.15 - 0.10 NS 6+3

100 1 0.2 - 0.15 NS 6

99 0 - 3

100 2 0.08 - 0.07 NS 6+3

100 0 - - 6+3

100 0 6


99 62 <0. 00005 S 6

48 22 <0. 00005 S 6


   aFor groups 1-22, 52 females and 48 males were used.
   t>NS * not statistically significant.
   CS = statistically significant at the 5% level.
For group 23, 24 females and 24 males were used,

-------
                      TABLE  7-8.   EXPOSURE SCHEDULE FOR BIOASSAY OF CHROMIUM COMPOUNDS BY INTRAPLEURAL INJECTION
                                                            (Hueper 1955)
NS
VO
Species Strain
mice C57BL
mice Strain A
rats Bethesda Black
rats Bethesda Black
rats Bethesda Black
rats Bethesda Black
rats Bethesda Black
rats Osborne-Mendel
rats Osborne-Mendel
guinea pigs NR
Number of Compound
animals Compound (mg)
50
55
25
35
42
39
14
25
25
26
metallic 0.001
chromium powder
mixed 1 or 2
chromium dust
chromite roast 25
chromite roast 25
minus Na2Cr04
chromium acetate 25
K2Cr207 2
CaCr04 12.5
metallic 16.8
chromium powder
chromite ore 36.7
metallic 67.2
chromium powder
Number of
injections
6 injections at
2-week intervals
4 injections at
4- to 6-week
intervals
single implant
single implant
in 50 mg of fat
8 implantations
over 13 months
single implant
single implant
6 injections at
monthly, intervals
6 injections at
monthly intervals
6 injections at
monthly intervals
Reference
Hueper
Baet jer
Hueper
Payne 1
Hueper
Hueper
Hueper
Hueper
Hueper
Hueper
1955
et al. 1959
1958
960a
and Payne 1962
and Payne 1962
and Payne 1962
1955
1955
1955
    NR = Not reported.

-------
site or in other organs, was observed.  Payne (1960a)  implanted chromite roast,




from which the soluble sodium chromate was extracted,  into the pleural cavity




of 35 rats.  Each rat received 25 mg of this material  plus 50 mg of sheep fat,




which corresponded to 2 mg of total chromium, of which 0.4 was hexavalent




chromium.  None of the 35 control animals developed tumors, while three of the




treated animals developed implantation site tumors.  In an earlier study (Hueper




1958) using chromite roast not leached of sodium chromate, none of the




25 treated male Bethesda rats developed implantation site tumors during 24




months; however, the early deaths of nine of the treated animals appreciably




decreased the number of animals at risk.  Hueper and Payne (1962) noted that no




implantation site tumors were observed in 42 rats during a 24-month period




following eight implantations of 25 mg of trivalent chromium acetate in gelatin




over a 13-month period.  Using a single implant of 2 mg of potassium dichromate




into the pleural cavity, 1 of 39 rats developed a tumor at the implantation




site.  In this study, only calcium chromate elicited a high tumor incidence




following implantation.  Of the 14 rats treated with 12.5 mg of calcium chromate,




eight developed tumors at the site of implantation.  These studies suggest that




intrapleural implantation of some hexavalent chromium compounds might be carcino-




genic, with calcium chromate producing the most dramatic response.  Hueper




(1961) also reported that many hexavalent chromium compounds produce tumors




upon intrapleural implantation, while trivalent compounds were less effective;




however, no experimental detail, including dose, was provided.  A summary of




the tumor incidences reported is presented in Table 7-9.




     Baetjer et. al. (1959) also used intrapleural injection to assess the car-




cinogenicity of mixed chromium dust, containing both trivalent and hexavalent




chromium, in 30 male and 25 female strain A mice.  The mice received four doses




of dust suspended in olive oil, with each dose containing 0.07 mg of chromium
                                      7-30

-------
 (Table 7-9).  No increase in tumor incidence or number of lung tumors per mouse

 was observed during the period extending 52 weeks after the first treatment.
     TABLE 7-9.  COMPOUNDS REPORTED TO HAVE BEEN TESTED FOR CARCINOGENICITY
                          BY INTRAPLEURAL IMPLANTATION3
                                 (Hueper 1961)
Compound
Calcium chromate
Sintered calcium chromate
Strontium chromate
Lead chromate
Barium chromate
Sodium di chromate
Zinc yellow
Chromic chromate
Chromite roast residue
Chromium acetate
Sheep fat controls
Valence
+6
+6
+6
+6
+6
+6
+6
+6, +3
+6, +3
+3
NAC
Number of rats
with tumor s^
20
17
17
3
1
Oa
22
26
5
1
0
Percent of
tumor incidence
57
49
74
9
3
0
63
74
14
3
0
aAll animals died by the 13th to 15th month of the study,
bThere were 35 rats per group at the start.
CNA = Not applicable.
     Davis (1972) injected trivalent chromite [FeO(CrAl^03]  into the pleural

cavity of 25 BALB/c mice and observed only small granulomas in the lungs.  The

animals were treated with a single injection of 5 mg of  finely ground ore (<1

urn) containing 1  mg of chromium.   The mice were killed at intervals of 2 weeks

to 18 months,  and the lungs were  examined with the aid of an electron microscope.


                                      7-31

-------
A carcinogenic response was not observed in mice following intrapleural injec-




tion; however, the number of chromium compounds studied was limited.




     The potential of trivalent chromium to produce lung tumors has been studied




in  the sensitive strain A mouse.  Shimkin and Leiter (1940) injected 5 mg of




chromite ore  (39 to 60% 0^03) into the tail vein of 37 animals.  Periodic kills




of  10, 10, and 17 animals were performed at intervals of 2, 4, 5, and 6 months.




respectively, and the lungs were examined for tumors.  The mice treated with




chromite ore had neither a greater incidence of lung tumors nor a greater num-




ber of tumors per tumor-bearing lung than the 72 control mice.  More recently,




Stoner et al. (1976) and Shimkin et al. (1978) reported similar negative results




for trivalent chromium sulfate following intraperitoneal administration to strain A




mice.  In this study, groups of 20 mice received 100%,  50%, or 20% of the maximum




tolerated dose (2,400 tng/kg) in 24 injections given three times/week.  The ani-




mals were examined for tumors at the end of 30 weeks.  In all of these studies,




positive controls were used to demonstrate the sensitivity of the strain A mouse




to the development of chemically induced multiple lung tumors.




     Although increased risk of lung cancer has been associated with the chromium




industry, as discussed below,  it has proven difficult to demonstrate a carcinogenic




response in the lungs of experimental animals.  Trivalent chromium (Cr III)  com-




pounds have not produced lung tumors after inhalation,  intratracheal implantation,




or intrapleural implantation,  while hexavalent chromium (Cr VI) was not carcino-




genic by inhalation or intratracheal instillation.   Some hexavalent chromium




compounds did produce tumors following intrabronchial or intrapleural implanta-




tion; however, the small number of animals (14)  used by Hueper and Payne (1962)




in the study of calcium chromate,  and the lack of detail in the report of




Hueper (1961), where  a number  of hexavalent  chromium compounds were reported to




be carcinogenic,  make it difficult to evaluate the  carcinogenicity of these






                                      7-32

-------
compounds to rodent respiratory tissue.  For these reasons, studies of respira-




tory cancer in animals do not provide substantial confirmation of lung cancer




associated with workers in the chromium industry.  However, the limited data




does suggest that of the two valences, hexavalent chromium is more likely to be




the etiologic agent in chromium-induced cancer.






     7.2.1.5.  INJECTION STUDIES FOR SITES OTHER THAN LUNG — Attempts have




been made to demonstrate chromium-induced carcinogenesis in other than respi-




ratory tissue.  In an early study, Hueper (1955) injected either powdered chro-




mium or chromite ore into the marrow cavity of the femur of rats, rabbits, and




dogs.  The experimental conditions are described in Table 7-10.  Of the animals




treated, only one rat developed a tumor at the site of injection, and other




tumors observed in the treated and control groups were not considered to be




treatment-related.  Similar negative results were obtained by Hueper (1955)




following intraperitoneal injection of chromium powder in rats and mice and




intravenous administration of chromium powder in mice, rats, and rabbits.  The




experimental conditions used in these studies are also presented in Table 7-10.




Although some tumors were present in treated rats, these tumors were similar to




those in the controls, except in the cases of two treated rats that developed




unique insulomas of the pancreas after intraperitoneal administration of powdered




chromium, and two treated rats that developed lung adenomas.  While no tumors




were observed in the controls, the causal relationship between chromium exposure




and the observed tumors is highly questionable.




     Injection site tumors developed in animals after subcutaneous administration




of chromium compounds in some, but not all, studies.  Payne (1960a) treated groups




of 52 C57BL mice (26 males and 26 females) with size-fractionated particles of




chromium residue dust or chromic phosphate.  The animals received a single sub-




cutaneous injection of 10 mg, after which they were observed for life.  The com—




                                      7-33

-------
       TABLE 7-10.  EXPERIMENTAL CONDITIONS USED TO STUDY THE EFFECT OF INTRAFEMORAL,  INTRAPERITONEAL,  AND INTRAVENOUS
                                                 ADMINISTRATION OF CHROMIUM
                                                        (Hueper 1955)
Route
intrafemoral
intrafemoral
intrafemoral
intrafemoral

-j
(jj intrafemoral
intrafemoral
intraperitoneal
intraperitoneal
intravenous
intravenous
Species
rats
rats
rabbits
dogs

rats
rabbits
mice
rats
mice
rats
Number of
animals
Strain (M, F)
Osborne-Mendel 25 M
Wistar 25 M
Dutch 8 F
mixed breed 5 F

Osborne-Mendel 15 M, 10 F
Dutch 4 F
C57BL 53 M
Wistar 25 M
C57BL 25 M
Wistar 25 M
Chromium
compound
powdered chromium
powdered chromium
powdered chromium
powdered chromium

chromlte ore
44% Cr203
chromite ore
44% Cr203
powdered chromium
powdered chromium
powdered chromium
powdered chromium
Dose
100 mg
100 mg
140 mg
170 to 399
mg followed
in 24 months
by 340 to
to 798 mg
36 mg
147 mg
1 mg/week
for 4 weeks
5 mg/week
for 6 weeks
0.25 mg/week
for 6 weeks
9 mg/week
for 6 weeks
Duration of
observation
24 months
24 months
3 to 58 months
60 months

24 months
20 to 50
months
21 months
NR
18 months
NR
intravenous
                  rabbits
                                    NR
8 F
            powdered chromium
2.5 mg/kg/week  36 months
for 6 weeks,
treatment
repeated 4
months later
NR - not reported.

-------
position of the dust fraction as related to trivalent and hexavalent chromium is




presented in Table 7-11.  A low incidence of injection site tumors (3 of 52) was




observed in animals treated with the unfractionated residue dust, while no tumors




were present in the controls or in animals treated with smaller particles, even




though these smaller particles had a higher proportion of hexavalent chromium.  In




a study of identical design, Payne (1960b) treated mice with sintered chromium




oxide, sintered calcium chromate, and calcium chromate.  Only one injection site




tumor was observed, and this was in an animal treated with calcium chromate.




Roe and Carter (1969) reported that 20 weekly injections of calcium chromate at




a dose of 5 mg for the first 2 weeks and 0.5 mg for the remaining 18 weeks,




resulted in a 75% (18 of 24) incidence of injection site tumors.  Although the




title of Roe and Carter's (1969) article and the legend to the tabulated results




described the route of administration as subcutaneous injection, the experimental




section and the conclusions described the treatment as an intramuscular injection




into the flank.  As a result of this uncertainty,  it is unclear whether any




chromium compound has been demonstrated to produce injection site tumors following




subcutaneous administration.







     7.2.1.6.  IMPLANTATION STUDIES — Intramuscular implantation has also been




used with varying success to demonstrate that chromium compounds are carcinogenic.




Hueper (1958) and Payne (1960a) implanted chromite roast or chromium residue




dust mixed with sheep fat into the thighs of Bethesda Black rats.  The respective




incidence of injection site tumors was 3 of 31  for animals given 25 mg of




chromite roast  and 1  of 35 for animals receiving the same doe of dust.   In both




studies, no tumors were present in the sheep fat-treated control animals.  Payne




(1960a)  also implanted 10 mg of chromium dust into the thighs of 52 C57BL mice




and observed no injection site tumors.  Hueper  and Payne (1959)  and Payne




(1960b)  used similar  techniques in the investigation of pure chromium compound.




                                      7-35

-------
                  TABLE  7-11.   LEVELS  OF  HEXAVALENT CHROMIUM  IN
                            FRACTIONATED  RESIDUE DUST
                                  (Payne  1960a)
 Material
       Weight of chromium as Cr/dose
Hexavalent (mg)               Total (mg)
 Vehicle
  (tricaprylin)

 Dust residue  extracted
with H20
Dust residue
5 to 10
Dust residue
<2
Chromic phosphate
0.037
0.17
0.45
0.003
0.50
0.69
0.68
2.64
In a small study, Payne (1960b) observed two injection site tumors in six

Bethesda Black rats after implantation of a gelatin capsule containing 12.5 mg of

calcium chrornate.  In the study by Hueper and Payne (1959), 25 mg of a chromium

compound was mixed with sheep fat prior to implantation into groups of 35

Bethesda Black rats.  The implantation site tumor incidence was 8 of 35 for

calcium chromate, 8 of 35 for sintered calcium chromate,  15 of 35 for chromium

oxide, and 0 for 35 for barium chromate.  On implantation of 10 mg of sintered

calcium chromate into the thighs of 52 C57BL mice;  nine implantation site tumors

developed; however, only one tumor developed following the implantation of calcium

chroma.te.   Hueper (1961) reported on the development of implantation site tumors

following treatment of rats with a number of chromium compounds (Table 7-12);

however,  details of this study,  including dose given,  were not reported,  and

thus it is difficult to relate this study to the  other reports of implantation


                                      7-36

-------
    TABLE 7-12,  COMPOUNDS REPORTED TO HAVE BEEN TESTED FOR CARCINOGENICITY
                         BY INTRAMUSCULAR IMPLANTATION
                                 (Hueper 1961)
Compound
Valence
Number of tumors3
aThere were 35 rats/group at the start.
NA = Not applicable.
                                                                  Percent of
                                                               tumor incidence
Calcium chr ornate
Sintered calcium
chromate
Strontium chromate
Lead chromate
Barium chromate
Sodium dichromate
Zinc yellow
Chromic chromate
Chromite roast
residue
Chromium acetate
Sheep fat control
+6
+6
+6
+6
+6
+6
+6
+6, +3
+6, +3
+3
NA
9
12
15
1
0
0
16
24
1
1
0
25
34
43
3
0
0
46
69
3
3
0
site tumors.  The intramuscular implantation technique has provided relatively

consistent findings that some hexavalent chromium (Cr VI)  compounds are tumorigenic

in laboratory animals.

     Neither trivalent (Cr III) nor metallic chromium compounds have produced

implantation site tumors following intramuscular implantation.   Hueper and

Payne (1962) implanted 25 tng of chromic acetate into the thighs of 35 Bethesda

Black rats.   After a 24-month observation period,  only one animal  developed an

injection site tumor.  In a study using powdered chromium,  Sunderman et al.

                                      7-37

-------
(1974) observed no tumors in 24 male Fischer rats  after a 112-week observation




period.  Atomic absorption spectroscopy indicated  that  each  rat  received 2  mg




of dust.  Similar results were obtained by Hueper  (1955)  following repeated




injection of powdered chromium into the thighs  of  25  C57BL mice.   Each  animal




received two injections of 0.1 mg at 2-week intervals,  and this  was repeated  3




weeks later for a total dose of 0.4 mg.  No tumors developed in  the 15  mice




that survived 3 to 13 months.   Although trivalent  chromium was not tumorigenic




following intramuscular implantation,  only one  compound was  tested under a




limited experimental protocol, and it is only speculative that zero-valent  and




trivalent chromium would continue to give negative results with  further testing.




     Maltoni (1974, 1976) gave single subcutaneous injections of  30 mg  hexavalent




lead chromate or hexavalent lead chromate oxide in water to  groups of 40 Sprague-
Dawley rats.  Lead chromate produced 24/40  and  27/40  sarcomas  respectively at  the




site of injection within 117 to 150 weeks.   No  local  sarcomas  were  observed in




60 vehicle-treated control rats,  and in 80  untreated  control rats receiving com-




parable subcutaneous injection of unspecified iron pigments, only one  local




sarcoma was observed.




     Furst et al. (1976) studied  the carcinogenicity  of  hexavalent  lead  chromate




and calcium chromate in rats.  Groups of 25 male  and  25  female Fischer-344 rats




were given monthly intramuscular  injections of  8  mg hexavalent lead chromate




suspended in trioctanoin for 9 months or 4  mg hexavalent calcium chromate




suspended in trioctanoin for 12 months.




     Calcium chromate produced three fibrosarcomas and two rhabdomyosarcomas




at the injection site in 5/45 rats, whereas hexavalent lead chromate produced




14 fibrosarcomas and 17 rhabdomyosarcomas at the  site of injection  in 31/47 rats.




In addition, 3/24 lead chromate treated male rats developed renal  carcinomas.




None of the above tumors were found in controls injected with  the  vehicle.






                                    7-38

-------
     Furst et al. (1976) also investigated the carcinogenicity of hexavalent




lead chromate in mice.  A total of 25 female NIH Swiss mice were given four




monthly intramuscular injections of 3 mg hexavalent lead chromate in trioctanoin.




Two lymphomas were observed within 16 months and three lung adenocarcinomas within




24 months among 17 mice necropsied.  Similar incidences were observed in vehicle-




injected and untreated female NIH Swiss mice.






     7.2.1.7.  ORAL STUDIES — Trivalent chromium (Cr III) has been tested




for carcinogenicity by the oral route in mice and rats.   Schroeder et al.




(1964) exposed a group of 108 (equal numbers of male and female) Swiss mice to




drinking water containing 5 ppm of chromium as chromium acetate.  The lifetime




exposure to this level of chromium had no effect on the longevity of females,




and only a slight decrease was noted in the longevity of males.  There was no




increase in tumor incidence in the treated animals as compared with controls.




In a similar study, Schroeder et al. (1965) exposed 46 male and 50 female Long




Evans rats to drinking waLet couLdiaiuy 3 ppm of chromium as chromium acetate.




Again, lifetime exposure to this level of chromium had only a slight effect on




longevity, with no increase in tumors in treated as compared with control




animals.  It should be noted that only one dose level of chromium was used in




this study, and from the lack of overt signs of toxicity, it may be concluded




that higher dose levels could be tolerated.  Higher dose levels would increase




the likelihood of detecting a carcinogenic response from a weak carcinogen.




Lane and Mass (1977) observed carcinogenic activities of chromium carbaryl as




well as synergistic activities with benzo[a]pyrene in rats following tracheal




grafting techniques.




     Ivankovic and Preussman (1975) incorporated trivalent chromium oxide into




the diets of 60 male and female BD rats.  The trivalent chromium oxide was



baked into bread at levels of 1, 2, or 5%, and fed to the rats 5 days/week for




                                      7-39

-------
2 years.  The only effect of treatment was a dose-dependent decrease in liver




and spleen weight.  Both the longevity and tumor incidence in the treated




animals were similar to that of control animals.  Again, the lack of major




toxic effects of treatment may indicate that this chromium compound could have




been tested at higher levels in the diet.  The authors commented that the




negative observations may have resulted from the poor absorption of chromium




from the gastrointestinal tract.






     7.2.1.8.  SUMMARY OF ANIMAL STUDIES — A summary of the animal carcino-




genicity studies of chromium is presented in Table 7-13.  To date, chromium




compounds have not induced significantly increased incidences of tumors in




laboratory animals following exposure by the inhalation and ingestion routes.




Neither trivalent (Cr III) nor hexavalent (Cr VI) chromium compounds have induced




significantly increased incidences of lung tumors by inhalation.  Similar results




have been obtained following the ingestion of trivalent chromium compounds;




however, studies have not been reported in detail.  There is some positive




evidence that chromium, particularly some hexavalent chromium compounds, is




carcinogenic following subcutaneous injection or intrabronchial, intrapleural,




intramuscular, or intratracheal implantation; however, implantation site tumors




have only consistently been demonstrated using intramuscular implantation.  Of




all the chromium salts, calcium chromate is the only one that has been consistently




found to be carcinogenic in rats by several routes.   Calcium chromate, strontium




chromate, zinc chromate, sodium dichromate, lead chromate, lead chromate oxide,




and sintered chromium trioxide have produced local sarcomas or lung tumors in




rats at the site of application.  Although the studies available indicate that




metallic chromium powder and trivalent chromium compounds are not carcinogenic,




these compounds have been studied less extensively than hexavalent chromium




compounds.  The relevance of studies using intramuscular implantation to human




                                      7-40

-------
TABLE 7-13.   CARCINOGENICITY OF  CHROMIUM COMPOUNDS IN EXPERIMENTAL ANIMALS
Route of
administration
Inhalation



inhalation



inhalation

inhalation
^j
1
.p-
h— '


Inhalation





inhalation

inhalation



Compound
chromium-containing
dust


chromium-containing
dust


chromium-containing
dust
CaCrO^ dust






chromium-containing
dust




chromium— containing
dust
chromium-containing
mist and dust


Species/ Dose
strain as chromium
mice/Strain A 0.5 to 1 mg/m3



mice/Swiss 0.5 to 1 mg/m3



mlce/C57BL 0.5 to 1 mg/m3

mice/C57BL 4.33 mg/m3






rats/mixed breed 1 to 1.5 mg/m3
Wlstar and McCollum




rats/Wlstar 1 to 1.5 mg/nt3

rabbits 1.5 to 2 mg/ra3
guinear pigs


Duration
of exposure
4 h/d, 5 d/wk
for 16 to 54 wk


4 h/d, 5 d/wk
for 39 to 58 wk


4 h/d, 5 d/wk
for 41 to 42 wk
5 h/d, 5 d/wk
for life





4 h/d, 5 d/wk
for >70 wk




5 h/d, 5 d/wk
for life
4 to 5 h/d, 4 d/wk
the life of
guinea pig or 50
months for rabbits
Findings
No increase in the
incidence of lung
tumors or number of
tumors / lung
No increase in the
incidence of lung
tumors or number of
tumors/ lung
No lung tumors
observed
6 of 136 males and 8
of 136 females
developed lung tumors
as compared with 3 of
136 females and 2 of 136
male controls; the
significance is not clear
Increased incidence of
lymphosa rcomas
involving the lungs, 3
of 100 in experimental
and 0 of 85 in control
group
No change in lung
tumor incidence
No increase in the
incidence of lung
tumors

Reference
Baetier et al.
1959


Baetier et al.
1959


Baetier et al.
1959
Netteshe iro
et al. 1971





Baet jer er al.
1959




Steffee and
Baetier 1965
Steffee and
Baetier 1965



-------
TABLE 7-13.  (continued)
Route of
administration Compound
intratracheal chromium dust or
BaCr04 or ZnCr04


intratracheal ZnCr04

intratracheal chromium
instillation dust
intratracheal ZnCr04 or
instillation PbCrO^
intratracheal ZnCr04 or
instillation PbCr04
intratracheal Na2Cr20?
application



I
i
N)

intratracheal CaCr04
application




intrapleural Cr powdered metal
injection

intrapleural mixed chromium dust
injection


intrapleural FeO(CrAl)203
injection
intrapleural chromite ore
injection
intrapleural Cr powdered metal
injection
Species/
strain
mice/Strain A
Swiss, C57BL


mice/Strain A

rats/mixed breed
Wistar and McCollum
rabbit

guinea pigs

rats/
Sprague-Dawley







rats/
Sprague-Dawley




mice/C57BL


mice/Strain A



mice/Balb/c

rats /Os borne-Mendel

rats/Os borne-Mendel
guinea pigs
Dose
as chromium
0.01 to 0.5 mg/
injection


0.01 to 0.03 mg/
injection
0.02 mg/injection

2.3 to 2.8 mg/
injection
0.7 to 0.86 mg/
injection
1 x per week
0.05 mg/kg/wk
0.25 mg/kg/wk
1.25 mg/kg/wk

5 x per week
0.01 mg/kg/wk
0.05 mg/kg/wk
0.25 mg/kg/wk
1 x per week
1.25 mg/kg/wk

5 x per week
0.25 mg/kg/wk

0.001 mg/
injection

0.07 mg/
injection


1 mg

36.7 mg (of ore)

16.8 mg
67.2 mg
Duration
of exposure
5 to 6 injections
at 4 to 6 wk
intervals

6 injections at
2 wk intervals
15 injections at
2 wk intervals
3 to 5 injections
at 3 mo intervals
6 injections at
6 wk intervals
30 months




30 months



30 months


30 months


6 injections at
2 wk intervals

4 injections at
4 to 6 wk intervals


single injection

6 injections at
1 mo intervals
6 injections
at 1 mo intervals
Findings
No increase in the
incidence of lung
tumors or the number
of tumors /lung
No statistical increase
in lung tumors, 31
No lung tumors
observed
No lung tumors
observed
No increase in lung
tumor incidence
Significant
increased incidence
of lung tumors
at the highest
dose
No lung tumors
observed


Significant
increased Incidence
of lung tumors
Increased
incidence
of lung tumors
No significant increase
in injection site
tumors
No increase in lung
tumor incidence or
number of lung tumors/
mouse
Only small
granulomas observed
No significant increase
in injection site tumors
No significant increase
in injection site tumors
Reference
Baetjer et al.
1969


Steffee and
Baetler 1965
Baetjer et al.
1959
Steffee and
Baetjer 1965
Steffee and
Baetjer 1965
Steinhoff et al.
1983



Steinhoff et al.
1983


Steinhoff et al.
1983

Steinhoff et al.
1983

Hueper 1955


Baetjer et al.
1959


Davis 1972

Hueper 1955

Hueper 1955

                                                              (continued on the following page)

-------
TABLE 7-13.  (continued)
Route of
administration
intrapleural
implant


intrapleural
implant


intrapleural
implant


intrapleural
implant
intrapleural
implant
intrabronchial




intrabronchial

intrafemoral



intrafemoral

Species/ Dose
Compound strain as chromium
chromite roast rats/Bethesda Black 25 mg (of roast)
minus NaCr04


K2Cr2t>7 rats/Bethesda Black 0.35 mg


CaCr04 rats/Bethesda Black 4.2 mg



Cr(C2H302)3 rats/Bethesda Black 5.2 mg/implant
chromite roast rats/Bethesda Black 25 rag (of roast)

variety of rats/Parton 2 mi;
chromium compounds Wistar



21 compounds rats/Parton 2 mg
Wistar
metallic chromium rat/Osborne-Mendel 100 mg
rats/Wistar 100 mg
rabbits/Dutch 140 mg

chromite ore rats/Osborne-Mendel 15 -mg
rats/Dutch 64 mg
Duration
of exposure
single implant
in sheep fat


single implant
in sheep fat


single implant
in sheep fat


8 implants over
13 mo
single implant

single implant




single implant

single injection



single injection

Findings
3 of 35 animals
developed implant
site tumors; none
in controls
1 of 39 animals
developed implant
site tumors; none
in controls
8 of 14 animals
developed implant
s ite tumors , none
in controls
No implantation site
tumors in 24 animals
No implant site
tumors
See Table 7-6




See Table 7-7

No injection site
tumors developed
except for a single
tumor in one rat
No injection site tumors

Reference
Payne 1960a



Hueper
and Payne 1962


Hueper
and Payne 1962


Hueper
and Payne 1962
Hueper 1958 .

Levy and
Venitt 1975
(as reported
in NIOSH
1975)
Levy and
Martin 1983
Hueper 1955



Hueper 1955


-------
Table 7-13.  (continued)
Route of Species/
administration Compound strain
Intraferaoral metallic chromium dogs/mixed breed


Intraperltoneal 0^(804)3 mice/Strain A



intraperitoneal metallic chromium mice/C57BL
-J
1
*; intraperitoneal metallic chromium rats/Wistar


intravenous chromite ore mice/Strain A



intravenous metallic chromium mice/C57BL
rats/Wistar


intravenous metallic chromium rabbits/NR


Dose
as chromium
170 to 399 mg
followed by
340 to 798 mg
1.3 to 6.6 mg/
injection


1 mg/lnjection


5 rag/inject ton


1.95 to 3 mg



0.25 mg/injectlons
9.0 mg/injections


2.5 mg/kg


Duration
of exposure
second treatment
given 24 mo
after first
24 injections given
3/wk


4 injections at
1 wk intervals

6 injections at
1 wk intervals

single injection



6 injections at
1 wk Intervals


6 Injections at
1 wk Intervals
repeated in 4 mo
Findings
No injection site
tumors

No Increase in lung
tumor incidence or
number of lung
tumors /mouse
No tumors observed


Pulmonary adenomas in
2 of 25 animals; none
in controls
No increase in lung
tumor incidence or
number of lung tumors/
mouse
No tumors in mice
while tumors In rats
were identical to
controls
No adverse effects
after 36 months

Reference
Hueper 1955


Stoner et
al. 1976;
Shimkin et al.
1978
Hueper 1955


Hueper 1955


Shimkin and
Lelter 1940


Hueper 1955



Hueper 1955


                                                                (continued on the following page)

-------
Table 7-13.  (continued)
Route of
administration
subcutaneous








subcutaneous


intramuscular


•^j
1
Ui intramuscular


intramuscular



intramuscular





intramuscular

intramuscular

intramuscular

Compound
chromium residue dust
chromium residue dust.
5 to 10 p
chromium residue dust,
<2 p
chromic phosphate
sintered Cr03
sintered CaCr03
CaCr04
lead chr ornate
(VI) oxide

lead chromate
(VI) oxide



sintered
chromium
(VI) trioxide
metallic chromium



CaCr04
sintered CaCr04




chromium
residue dust
metal lie chromium

Cr(C2H302)3

Species/
strain
mice/CSTBL


.





rats/
S prague-Daw ley

rats/
Fischer 344



rats/
Bethesda Black

mice/C57BL



mice/C57BL





mice/C57BL

rats/Fischer

rats/Bethesda Black

Dose
as chromium
0.5 mg
0.69 mg

0.68 mg

2.64 mg
0.52 mg
0.37 mg
0.33 mg
30 mg


8 mg




25 mg


0.1 mg



3.3 mg
3.3 mg




10 mg (of dust)

2 mg

5.2 mg

Duration
of exposure
single injection








single injection


single injection




single implant


2 injections at
2 wk interval?
repeated 3 wks
later
single implant





single implant

single implant

single implant

Findings
3 of 52 animals
receiving chromium
residue dust and 1 of
52 receiving CaCrO^
developed injection
site tumors



injection site sarcomas
In 27/40 treated and 0/60
vehicle control animals
injection site sarcomas
in 31/47 treated and 0/22
vehicle control animals;
3 renal carcinomas

Implantation site sarcomas
in 15/35 treated and 0/35
control animals
No tumors in 25
animals


9 of 52 mice treated
with sintered CaCr04
had Implantation site
tumors , while 1 of 52
treated with CaCr04
developed tumors
No Injection site
tumors developed
No tumors in 24
animals
1 Implantation site
tumor in 35
Reference
Payne 1960a,b








Maltoni 1974,
1976

Furst et al. 1976




Hueper and Payne
1959

Hueper 1955



Payne 1960b





Payne 1960a

Sunderman et
al. 1974
Hueper
and Payne 1962
                                                  treated animals

-------
risk following inhalation or oral exposure to chromium compounds is not clear;




however, these animal studies may indicate that some hexavalent chromium com-




pounds are likely to be the etiologic agent in human chromium-related cancer*






7.2.2.  Epidemiologic Studies.




     7.2.2.1.  CHROMATE PRODUCTION WORKERS — The early association of respi-




ratory cancer with employment in chromium compound-related industries has been




reviewed by Baetjer (1950a).  The first case report appeared in 1890, with a




total of 122 reports of respiratory cancer in chromium compound-related indus-




tries collected between this date and 1950.  These cases were predominantly in




German and American industries,  with one case reported in Scotland and one case




reported in Switzerland.  The workers in the chromate industry were exposed to




chromite ore (trivalent chromium) and sodium monochromate, sodium bichromate,




and chromic acid (hexavalent chromium), along with vapors and gases associated




with the chromate manufacturing  process.  According to Baetjer, the early German




investigators suggested LtiaU liexavaleut chromium was the etiologic agent in




respiratory cancer, since respiratory cancer was not associated with the mining




of trivalent chromite ore.  These early observations do not provide information




on the relative incidence of respiratory cancer in the chromate workers as com-




pared with the general population, nor were the studies sufficiently large or




controlled to support the conclusion that chromium exposure was related to




respiratory cancer.  However, these early reports were the impetus for initiating




a number of epidemiologic studies of the chromate manufacturing industry in the




United States, Great Britain, and Japan.  Although a relatively large number of




epidemiologic studies have been  conducted of this industry, the individual




studies were often analyzing cancer incidence from the same cohort of workers.




In order to clarify the interrelationship of the cohorts in these studies, the
                                   7-^6

-------
 locations  of the plants from which  each  study  derived  its exposed  population are




 presented  in Table 7-14.   It should be noted that  studies of  the same  plant  by




 different  investigators often resulted in the  vital  statistics  of  individual




 workers  being used in more  than  one study.   The  result  was  that in many  cases,




 these  epidemiologic  studies  verified  the  observations of  previous  studies  rather




 than adding  evidence from additionally exposed population groups.




     In  response to  the early reports associating  lung  cancer with the chromate




 industry,  the industry initiated  a  retrospective epidemiologic  study of  the  seven




 chromate plants  in the United States  (Machle and Gregorius  1948).  A total of




 1,445  workers were employed  in the  seven  plants, with each  plant employing between




 50  and 5UO workers.   The  company  group life  insurance records were used  to deter-




 mine causes  of death.   Adequate records were available  for  six  of  the  plants, and




 the  cohort of men actively working  in the chromate industry consisted  of 11,019




 man-years of  experience.  In  this cohort, 156  deaths were observed, 32 of which




 were from lung cancer.  An additional 10  lung  cancer deaths were reported of the




 37 deaths from the plant  with  work  records unsatisfactory for the purpose of the




 epidemiologic  analysis.   The period of study varied with each plant from 4 to 17




 years,  depending  on  the availability  of mortality data.  Of the total  deaths




 observed in the  chromate  industry, 21.8%  (42 of 193)  were from lung cancer, com-




 pared  to an expected 1.3% (10  of 733) as  calculated from a comparable  industrial




 group  not exposed to chromium  (industrial life  insurance policyholders  for the




 year 1947,  Metropolitan Life Insurance Co.).  This difference is statistically




 significant at P < 0.01.  When examined  individually, five of the  seven plants




were reported to have respiratory cancer  proportionate  mortality ratios from 13




to 31 times that expected.  The crude respiratory cancer mortality  rate per 1,000




males was also found to be significantly  (P < 0.01) increased over  the  crude




lung cancer mortality rate of the group of life insurance holders.   This  was

-------
                                      TABLE 7-14.  LOCATION OF CHROMATE MANUFACTURING PLANTS WHICH PARTICIPATED IN EPIDEMIOLOGIC STUDIES AND PLANTS FROM
                                                                     WHICH VITAL STATISTICS WERE OBTAINED FOR EACH STUDY

Machle
Location and
of
plant
Gregorlus
1948
Brlnton
et al.
1952
(also pub.
as part of
PHS 1953)
Mancuso
and
Hueper
1951

Hayes
Mancuso Baetjer et al.
1975 1950s 1979
Hill
and'
Ferguson
1979


Taylor Enterllne
1966 1974


Bldstrup
1951

Bldstrup
and
Case 1956

Alderson
et al.
1981

Ohsakl
et al.
1978
Watanabe
and
Fukuchl
1975

Satoh
et al.
1981

Korallus
et al.
1982


Blttersohl
1971
Glens Falls,  +
 NY

Jersey City, NJ
 Plant fl     +
 Plant »2     +

Baltimore,    +
 MD

Kearny, NJ    +

Newark, NJ    -f

Palnes-
 vllle, OH    +

Bolton,
 England

Rutherglen,
 England

Eaglescllff,
 England
+ - Participating chromate manufacturing plants.
- - Non-participating chromate manufacturing plants.
aThe plant In the Watanabe and Fukuchl (1975) and the Ohsakl et al.  (1978)  studies  nay  be  one and  the  sane;  It  Is
 Impossible to tell from the literature.  Both plants were reported  to be  located on Hokkaido Island,  Japan.
bPlant II is the larger of the two plants.  Machle and Gregorlus (1948) reported that It had 350 employees as
 compared to 150 employees In Plant 12.

-------
                                                                   TABLE 7-14.   (continued)
Brlnton
et al.
Machle 1952 Mancuso • Hill Watanabe
Location and (also pub. and Hayes and Bldstrup Alderson Ohsaki and Satoh Korallus
of Gregorlus as part of Hueper Mancuso Baetjer et al. Ferguson Taylor Enterllne Bidstrup and et al. et al. Fukuchi et al. et al.
plant 1948 PHS 1953) 1951 1975 I950a 1979 1979 1966 1974 1951 Case 1956 1981 1978 1975 1981 1982
Hokkaido
Islands ,
Japan - - _____ ~_ __ _ +a+a__
Tokyo ,
Japan - - _____ __ __ _ __ + _
L Leverkusen,
^ W. Germany - - _____ - _ __ _ _ _ _ +
Uerdlngen,
W , Ge rma ny- - _____ _ - __ _ ___ +
Leuna Chemical
Combine,
E » Ge rmany - - ___-- -- __ _ ____




Blttersohl
1971


-

-

-

~


+
  a Participating chromate manufacturing plants,
- J Non-participating chromate manufacturing plants*
aThe pla.it in the Watanabe and Fukucht (1975) and the Ohsaki et al.  (1978) studies may be one and the same;
 Impossible to tell from the literature.  Both plants were reported  to be located on Hokkaido Island, Japan.
bPlant #1 Is the larger of the two plants.  Machle and Gregorius (1948) reported that It had 350 employees as
 compared to 150 employees in Plant #2.
it is

-------
true for both the age group 50 and under and the age group 50 and over.  A




slightly increased crude mortality rate from digestive system cancer was also




reported (1.1-8 per 1,000 versus 0.59 per 1,000,  P < 0.01).




     Estimates of exposure were not made in this study,  since analytical data




were not available for a large portion of the period studied, and work records




did not report the shifting of personnel to different positions in the plant




during the course of employment.  A limitation of this study is that no age




adjustment was done in the comparison of the mortality rates of the control




group with the mortality rates of the exposed group.  In this regard, however,




it should be noted that there was a dramatic difference  in lung cancer mortality




between the chromate workers and the control group for both the 50 and under




age category and the over 50 age category.   Thus, it is  unlikely that a




preponderance of older persons among the chromate workers was responsible for




the large difference in lung cancer mortality between the chromate workers and




the control group.  Another limitation is that the authors used a lung cancer




mortality rate for oil refinery workers in the 1933-1938 period for comparison




with the chromate workers in the 1930-1947 period.  Lung cancer increased




dramatically in U.S. males between 1930 and 1947 (about  five times).  Thus, it




is possible that the lung cancer mortality rate for the  control group may have




a lower rate than that which would have been found for the period 1930-1947.




However, it is unlikely that the dramatic difference in  lung cancer between the




controls and the chromate workers could be explained by  the selection of a




control group from a slightly different time period than that of the exposed




group.




     Brinton et al. (1952) used the disability records between January 1, 1946




and December 31, 1950 of the seven United States chromate plants to determine




occupational diseases associated with the chromate industry.  These data were






                                      7-50

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 subsequently published as part of the Public Health Service  (1953) report,




 "Health  of Workers in a Chromate-Producing  Industry."  The cohort was  limited




 to men who belonged to the company disability plan, which prior to 1949 was




 voluntary.  After 1949, participation in the plan was mandatory in all but two




 plants,  although participation in these plants was near 100% by the end of the




 study.   Only deaths that occurred within 1  year of beginning disability status




 were included in this study, and the determination of the cause of death was




 made solely on what was listed as "cause of death" on the death certificate.




 The health experience of a "large group of  industrial workers (predominantly




 white)"  was used for comparison.  The incidence of most disabilities was com-




 parable  between chromate workers and the reference population,  with the exception




 of cancer.  Cancer at all sites had an incidence of 7.1 per 1,000 in chromate




 workers  and 0.7 per 1,000 in the control population (P < 0.01); however, it




 should be pointed out that the actual number of individuals who developed cancer




 was small (26 individuals) in the group of chromate workers.   Brinton et al.




 (1952) further studied the cancer experience in tne chromate  industry for the




 period 1940-1950, using death records obtained  from the group disability insurance




 plans.   Information was available for two plants for fhf> entire 1940-1950 time




 period:  one plant had records for 1943 to 1950,  three plants for 1946 to 1950,




 and one plant for 1949 to 1950.   During this 11-year period,  44 deaths from




 cancer at all sites  and 32 deaths from respiratory cancer were  observed.   This




corresponds  to a 4.5-fold increase in cancer at  all sites and a nearly 29-fold




 increase in respiratory cancer in the chromate  workers as compared  to males in




the United States as  a whole.   There  was  an indication in the data  that the




 increased risk of respiratory  cancer  was  greater in nonwhite  as compared  to




white  chromate workers;  however,  the  number of  individuals was  small  when




the cohort of chromate workers  was subjected to  this  further  subdivision.   The
                                      7-51

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authors commented on the limitations the study placed on the make-up of the




cohort as a result of the use of death records obtained solely from the company




disability plan, and suggested that the observed increased risk of respiratory




cancer represents a minimal value.




     Baetjer (1950a, b) studied a cohort consisting of lung cancer patients in




two Baltimore hospitals to determine if employees of the local chromate plant




were overrepresented in this group.  The records from Johns Hopkins Hospital




were examined for the period from 1925 to 1946, and from Baltimore City Hospital




from 1930 to 1948; 198 and 92 confirmed cases of lung cancer in males were




obtained, respectively, from each institution.  Control groups consisted of




age-matched male patients with a hospital stay of >10 days chosen at random




from the hospital records.  An additional control was used for Johns Hopkins;




this consisted of patients with cholelithiasis, since patients with this disease,




as well as lung cancer patients, may preferentially select a large medical




facility.  At Johns Hopkins, 7 of 198 lung cancer patients had worked in the




chromate industry; none of the 226 randomly sampled controls and none of the




177 cholelithiasis controls had worked in the chromate industry.  At the




Baltimore City hospital, 4 of 92 lung cancer patients and 0 of 499 control




patients reported exposure to chromium compounds.  The percentage of chromate




workers in the lung cancer group was statistically signficantly (P < 0.01)




greater than expected.  If one were to calculate the unadjusted odds ratios of




having lung cancer and being exposed to chromium, the odds ratios would be




abouf32 for the Johns Hopkins cases and about 23 for the Baltimore City Hospital




cases.  Both are statistically significant (P < 0.05).




     Mancuso and Hueper (1951) used vital statistics for all employees who




worked for J> 1 year in the Painesille, Ohio chromate plant during 1931 to 1949




to investigate chromate production-associated lung cancer.  Of the 2,931 deaths






                                      7-52

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 of males  in the  county  where  the  plant  was  located, 34  (1.2%) were  from  respiratory




 cancer, while  of the  33 deaths  among  the  chromate  workers,  6  (18.2%)  were  from




 respiratory cancer.   This  difference  is significant at  P <  0.01.  Mancuso  and




 Heuper  (1951)  indicated that  96%  of the workers  were  exposed  predominantly to




 insoluble  chromate.   Chemical analysis  of the  organs  of two deceased  workers,




 one  who had died from lung cancer and one who  had  died  from bladder cancer,




 revealed  that  the lungs appeared  to be  the  major storage depot  for chromium,




 with approximately 390  and 250  ug of  chromium  per  10  g  of tissue detected  in




 each individual  respectively.   The high level  of chromium in  the first subject,




 the  one who had  died  from  lung  cancer,  was  still detected despite the fact  that




 the  individual had not  been exposed to  chromium  for a period of 3.4 years.




 Chromium  levels  measured in the lungs of  nonexposed individuals were nearly




 zero.  Mancuso and Hueper  (1951)  suggested  that  the presence of insoluble  chromium




 in the lung may  have  been  an  etiologic  factor  in the observed higher incidence of




 cancer; however,  the  present  data are too limited  to support this conclusion.




     Mancuso (1975) followed  the  vital  status  until 1974 of 332 chromate plant




 workers from his  earlier study  (Mancuso and Hueper 1951) who had been employed from




 1931 to 1937.  Over 50% of  the 332 employees in  this cohort had died by 1974.




 Mancuso divided  this  group  of workers into  those employed from 1931 to 1932, 1933




 to 1934, and 1935  to  1937.  He  found that 63.6%, 62.5%, and 58.3%,  respectively,




 of the cancer deaths  in these groups were lung cancer deaths.   The latency




 period for  the lung cancer  deaths was  found to cluster around  27-36 years.  The




 author found that  lung cancer deaths were dose-related to insoluble (trivalent),




 soluble (hexavalent),  and total  chromium exposure,  and concluded that  lung




cancer mortality was  associated  with both trivalent and hexavalent  chromium.




Workers in this study  were exposed to  both trivalent  and hexavalent  chromium,




and  as exposure to one increased so did  exposure to the other.  Therefore,  an






                                      7-53

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observed dose-response to trivalent chromium may merely be a reflection of a




dose-response to hexavalent chromium,  or vice versa.   Thus, it is questionable




whether the author's conclusion with regard to a dose-response to both hexavalent




and trivalent chromium is correct.  Furthermore, the  lung cancer death rates,




which purport to show this dose-response, are based on very small numbers, and




thus the finding of dose-response is probably questionable.  For six deaths due




to lung cancer,  chromium levels well above control values were found in the




lungs of the deceased at autopsy 15-195 months after  the last exposure to




chromium, suggesting that the lung retains chromium for a considerable period




of time.




     Taylor (1966) studied a group of  1,212 chromate  workers for 24 years using




Old-Age and Survivors Disability Insurance records.  All of these workers were




employed in three United States chromate plants (Baltimore, Maryland; Painesville,




Ohio; and the larger of two plants in Jersey City, New Jersey) for >3 months




during the period 1937 to 1940.  The vital statistics of the group were




obtained through 1960, and where deaths occurred, the cause was determined




from death certificates.  Causes of death in this cohort were compared with age-




and cause-specific mortality rates for civilian males in the United States.  The




most dramatic increase in the standardized mortality  ratio (SMR) for chromate




workers occurred in respiratory cancer, with excesses of 8.5 times (71 observed




and 8.3 expected) observed by the termination of the  study in 1960.  Also, the




length of experience in the chromate industry, used as the only indication of




the extent of exposure, was compared with the incidence of lung cancer in this




cohort.  After 1937, duration of employment was determined from insurance




records, while prior to this date, duration of employment was determined by




extrapolation from the age-specific employment experience of the cohort.  Using
                                      7-54

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this method to determine length of exposure, Taylor found that respiratory
                         •
cancer mortality showed a dose-response by length of time exposed to chromate.

     Bittersohl (1971) studied cancer incidence among more than 30,000 employees

of the Leuna Chemical Combine in the German Democratic Republic (East Germany).

The chemical plant comprised several departments involving different chemical

exposures.  Ever since the plant had opened (in 1921 or earlier), its workers

had experienced increasing cancer incidence.  During the period 1958 to 1971,

588 malignancies were found among the male workers and 170 malignancies were

found among the female workers.  In most of the departments, no cases of cancer

were found.  However, in those departments with exposures to asbestos and tar,

coal gases, ammonia, or isobutyl oil, or exclusive exposure to asbestos, chromate,

or coal gases, the cancer incidence per 10,000 was much higher relatively than

the average for the plant.  In chromate production, the cancer rate was about

ninefold higher than that of departments where the above-described exposures

did not exist.  This rate exceeded the rates in departments with exposure to

either asbestos or coal gases.  It was less than the cancer rate for departments

where there was exposure to asbestos and tar,  coal gases, ammonia, or isobutyl

oil.

     This study appears to be nothing more than an interdepartmental comparison

of cancer incidence rates within a chemical works.  The author has not defined

a cohort for his study, and thus the results could be misleading with regard to

the cancer experience of chromate production workers if there was a high turnover

rate by department.  In connection with the data that are presented, the author

has provided little detail.  Organ-specific cancer incidence is not given,  and

the author does not state whether he is comparing crude rates or rates that are

sex- and age-adjusted.  Thus, although the cancer incidence rate for the chromate
                                      7-55

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production workers is strikingly high in comparison with nonexposed workers,




the study design and lack of detail render the results somewhat inconclusive.




     Enterline (1974) recalculated the expected deaths for the study by Taylor




(1966), but provided no explanation as to why this was done.  Enterline calculated




a respiratory cancer SMR of 942 for the 20-year observation period from 1940 to




1960.  Taylor had calculated a respiratory cancer SMR of 850 for the period




from 1937 to 1960.  Enterline (1974) showed that the relative risk of respiratory




cancer was greater in workers in the age group <45 years (14.1 times) as compared




with the older age group of 55 to 64 (6.8 times).  Enterline also showed that




the risk of respiratory cancer was highest shortly after the cohort was identified,




suggesting "a short latent period which is probably the result of exposure to a




very potent carcinogen."




     Hayes et al. (1979) conducted a cohort mortality study of workers at a




Baltimore, Maryland, chromium chemical production plant.  The plant underwent




extensive changes in the mill and roast operation and bichromate operations in




1950 and 1951, when a new facility was built to house these operations, and in




the chromic acid and special products operations in 1960,  when a new facility




was built to house these operations.  The new facilities were constructed for




the purpose of lowering employee exposure to chromium.  In this study, vital




status was determined on newly hired workers between 1945  and 1974 who had at




least 90 days of employment.  The cohort consisted of 2,101 employees, 1,803




laborers, and 298 managers, of which vital statistics were obtained for 88% of




the group as of 1977.  A comparison of lung cancer in this cohort was made




using .SMRs from the cause-specific mortality rates of Baltimore males, and was




tested for significance by means of the Poisson probability distribution.




Workers were divided into two exposure groups; the high or questionable exposure




group consisted of employees who worked in the old facilities and workers of






                                      7-56

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unknown exposure,  and the low exposure group consisted of workers employed only




in the new facilities.  In this study, no information was available on the




actual levels of exposure or the extent of difference in exposure between the




new and old plants.  Analysis of lung cancer mortality by specific jobs was




done after matching lung cancer cases by race, age,  time of initial employment,




and duration of employment to employees that died from noncancer causes.




     The SMR for lung cancer in the entire cohort of hourly workers was 202




(95% confidence limits of 155 to 263), which was statistically significant (P <




0.01).  The SMRs for both short-term (90 days to 2 years) and long-term (>^ 3




years) workers of the high and low exposure groups are presented in Table 7-15.




There was an apparent dose-response relationship, as associated with length of




employment, for the group initially hired between 1950 and 1959.  The lung




cancer SMR was statistically signficant (95% confidence limits did not include




1.00) for the workers with "high and questionable exposure" employed >3 years,




and who had initially been employed between 1950 and 1959.  In analyzing lung




cancer by job description, only workers in the special products department or




employees who worked in both the special products and bichromate departments,




the so called "wet end" of the production process (the production process in




the mill and roast department is referred to as the "dry end"), showed a sig-




nificantly (P < 0.05) elevated relative risk of lung cancer of 2.6 and 3.3,




respectively.




     In a study of the same plant investigated by Hayes et al. (1979), Hill and




Ferguson (1979) used a novel statistical analysis in an attempt to demonstrate




any trends in the risk of lung cancer associated with the modernization of the




plant.  The statistical method used was "probability window analysis," which




provided a method of comparing the number of cases of lung cancer in equivalent




time periods.  In comparing the number of lung cancers prior to 1951 (the time






                                      7-57

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        TABLE 7-15.  OBSERVED NUMBER OF DEATHS, STANDARDIZED MORTALITY RATIOS (SMRs),  AND 95% CONFIDENCE LIMITS (95% CL)
                                   FOR DEATHS DUE TO CANCER OF THE TRACHEA, BRONCHUS,  AND LUNG
                          AND TfaE NUMBER OF REPORTED DEATHS FOR WHICH NO CERTIFICATE COULD BE OBTAINED,
                          BY YEAR OF INITIAL EMPLOYMENT,  EXPOSURE CATEGORY, AND TOTAL DURATION EMPLOYED,
                                         FOR WORKERS INITIALLY HIRED AS HOURLY EMPLOYEES
                                                       (Hayes et al. 1979)
   Duration of
   employment"
Cause of
 death
                                                                  Exposure category3
  Observed
no. of deaths
Low exposure


         SMR (95% CL)C
Questionable and high exposure


                  SMR (95% CL)C
  Observed
no. of deaths
                                                     INITIALLY HIRED 1945 to 1949
I
Ui
oo
Short



Long



Trachea, bronchus NA NA
and lung
Cause not NA NA
determined^
Trachea, bronchus NA NA
and lung
Cause not NA NA
determined^
20

25

13

0

1.8
(1.1
NA

3.0
(1.6
NA


to 2.7)



to 5.2)


   aBased upon whether work exposure was exclusively in  a  new facility.   See  text.
   bShort:  90 days to 2 years; long:  ^3 years.
   cCalculated using an assumption that the observed number  of deaths  is  distributed  as  a Poisson random variable,
    P = 0.025, in each tail.
   ^Those reported deceased for whom no death certificate  could be  obtained.   If  these are distributed  by cause of  death in
    a similar way as the known deaths (cancer of the trachea,  bronchus, and  lung,  15%),  the reported  SMRs would be  increased
    slightly.
   NA = Not applicable.
                                                                                            (continued  on the following page)

-------
                                                 TABLE 7-15.   (continued)


Duration of
employment'5

Short

-j Long
Ul
VO

Exposure category3
Low exposure Questionable
Cause of Observed Observed
death no. of deaths SMR (95% CL)C no. of deaths
INITIALLY HIRED 1950 to 1959
Trachea, bronchus 2 0.7 (0.1 to 2.6) 12
and lung
Cause not 3 NA 7
determined^
Trachea, bronchus 3 4 .0 (0 .8 to 1 1 . 7) 9
and lung
Cause not 0 NA 0
determined^

and high exposure
SMR (95% CL)C

1.8
(0.9 to 3
NA
3.4
(1.6 to 6
NA




.1)

.5)

All
Trachea, bronchus
 and,  lung

Cause  not
 determined"*
INITIALLY HIRED 1960 to 1974

       NA


       NA
                                                                                                              NA
                                                                                                              NA
aBased upon whether work exposure was exclusively in a new facility.   See text.
bShort:  90 days to 2 years; long:  >^ 3  years.
cCalculated using an assumption that the observed number of deaths is distributed as a Poisson random variable,
 P = 0.025, in each tail.
^Those reported deceased for whom no death certificate could be obtained.  If these are distributed by cause of  death in
 a similar way as the known deaths (cancer of the trachea,  bronchus,  and lung,  15%), the reported SMRs would be  increased
 slightly.
 NA = Not applicable.

-------
of start-up of the new bichromate plant) with those after 1951, Hill and




Ferguson (1979) report a statistically significant (P < 0.01) decline from 23




to 7, and the authors suggested that this reduced risk of lung cancer resulted




from the engineering improvements that took place in 1951.  Comparing the time




periods 1932-41, 1942-51, 1952-61, and 1962-71, the number of bronchogenic




carcinoma deaths falling within these time periods ("windows") are 9, 7, 1, and




0, respectively.  The authors found a significant (P < 0.01) difference when




comparing the four groups under the null hypothesis that all classes have equal




probabilities of cancer mortality.  The GAG would agree with the review of this




study by the IARC (1980), in which it was stated that no conclusion on improved




safety in this chromate plant could be made, since the analysis only compared




lung cancer cases and not rates of lung cancer.  Also, this analysis does not




allow for the long latency period generally associated with lung cancer in the




chromate industry.




     Chromate plants in both England and Japan have also been studied to




determine if there is an association between employment in this industry and




lung cancer.  In an early survey,  Bidstrup (1951) performed lung X-rays of 724




workers employed in the three chromate plants in England in 1949.  This survey




detected only one case of lung cancer,  while the expected number would have




been 0.4, as indicated from the mass radiography units of the Ministry of




Health.  Of the 724 workers examined,  237 were employed for >15 years, and




although the numbers were too small for definite conclusions,  Bidstrup (1951)




suggested that it was unlikely that a 25-fold incrased risk of lung cancer,  as




reported in studies of United States plants,  was associated with employment in




the British plants.  Bidstrup's study was a cross-sectional study of only




currently employed workers, however.  Since workers with lung cancer or with




symptoms of lung cancer are likely to have dropped out of the working population,






                                      7-60

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it is probable that such results underestimate the difference in the incidence




or the risk of lung cancer in this group of workers.




     Bidstrup and Case (1956) performed a follow-up study between 1949 and 1955




of the 723 workers who participated in the radiographic survey.  During this




time, 217 workers were lost to the study as a result  of change in employment.




Of the remaining men, all but 59 were alive in 1955 when the study was terminated.




The age- and cause-specific deaths of these chromate  workers were compared with




the number expected based on vital statistics for the male population of




England and Wales.  There was no difference in either death rates for neoplasms




other than lung cancer or deaths from other causes; however, for lung cancer,




there were 12 observed deaths with only 3.3 expected.  This increase of 360%




was statistically significant (P = 0.005).  There was also a trend for greater




risk in the age group <45 years (7 observed and 1.3 expected; P < 0.01, as




calculated by the CAG); however, the numbers were too small to demonstrate if




this trend was statistically significant.  The effects of place of residence,




social class, and smoking habits on lung cancer incidence were considered too




small to account for this 360% increase in risk.  The authors noted that this




study was of short duration and that continued follow-up of this cohort would




probably reveal an even greater increased risk of lung cancer.  Of interest in




this study is the authors' report that 217 workers were lost to follow-up




because of change in employment.  Change of employment may well indicate a




change in health status, and thus may suggest that the difference in lung cancer




mortality may again be underestimated.




     Al.derson et al. (1981) conducted a cohort mortality study of workers at




three chromate plants in Great Britain.  This was follow-up of the earlier




studies by Bidstrup (1951) and Bidstrup and Case (1956).  Subjects were eligible




for this study if they had had an X-ray examination at work, had worked for a






                                       7-61

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minimum of one year's continuous service, and had been employed from 1948 to




1977.  Two of the plants, those at Bolton and Rutherglen,  were closed in .1966




and 1967, respectively.  Following these closings, production became concentrated




at the Eaglescliffe plant.  The national mortality rates for England and Wales




were used to calculate expected mortality for the plants at Bolton and Rutherglen.




For all plants together, the observed lung cancer mortality in relation to that




expected was statistically significant (observed/expected  = 2.419, P < 0.001).




For the individual plants, the observed/expected ratio was not significant




(observed/expected = 1.00, with 5 observed and 4.98 expected; P < 0.44) at the




Bolton plant while it was significant (P < 0.001) at the Eaglescliffe plant




(observed/ expected =» 2.156, with 36 observed and 16.20 expected) and the




Rutherglen plant (observed/expected = 2.854,  with 75 observed and 26.18 expected).




It should be noted, however, that the cohort  at the Bolton plant was relatively




small (202 workers)—not large enough to be reasonably able to detect a difference




between observed and expected lung cancer deaths.  It should also be noted that




the observed/expected nasal cancer mortality  ratio was statistically significant




(P < 0.05) at the Rutherglen plant.  The authors were interested in determining




if plant modifications affected the relative  risk of disease in men in the




earlier study by Bidstrup and Case (1956).  The authors found that the observed/




expected ratio of lung cancer deaths decreased from 3.0 (P < 0.01) for those




who worked before the plant modifications, to 2.0 (P < 0.005) for those who




worked before and after the modifications, to 1.9 (P < 0.290) for those who




worked after the modifications were completed.




     Because of the confounding factors  of age distribution of the workforce,




duration of employment, duration of follow-up, and environmental influences,




the authors did a multivariate analysis  of the data.  For  each individual, the




analysis compared the risks of developing lung cancer based on the following






                                       7-62

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factors:  duration of employment,  duration of follow-up,  calendar period of




employment, factory, age at entry, and estimated degree of chromate exposure.




The authors found the greatest contribution to the risk of lung cancer mortality




to be that of duration of employment followed by duration of follow-up, calendar




period of employment, entry age, and estimated degree of chromate exposure.  In




this study the authors reported that an earlier, unpublished report of the




study cohort presented data concerning the smoking habits of 70% of these workers,




who had completed a questionnaire.  The results of this survey indicated that




the percentage of heavy smokers was lower for the study cohort than that reported




for England and Wales (Todd 1962).  The authors concluded that the questionnaire




responses did not provide evidence that the respondents were at greater risk of




lung cancer due to to smoking than was the population as a whole.  Such a




conclusion must be considered questionable, however,  considering that 30% of




the cohort did not respond.  Other studies have found that the percentage of




smokers among nonrespondents to questionnaires is higher than among respondents




(Doll and Hill 1964, Criqui et al. 1979).




     Watanabe and Fukuchi (1975) followed a group of  136 chromate production




workers who worked or had worked in a chromate production factory on Hokkaido




Island, Japan.  The criteria for inclusion in the cohort was that the worker




must have been exposed for more than 9 years to chromium compounds.  The follow-up




period was 14 years, from 1960 to 1973.  Eight cases  of lung cancer and two




possible cases of lung cancer were identified during  the follow-up period.  The




authors did not state how the ten cases were identified.   Seven of these ten




cases had died during the observation period, including the two questionable




cases.  The dates and causes of the deaths were ascertained by the workers'




death certificates and by hospital records.  Based on national vital statistics




data, the expected number of lung cancer deaths for this population would be






                                       7-63

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0.33.  Thus the observed number of lung cancer cases is 21.2 times greater (if




the 2 questionable cases are counted with the observed lung cancer deaths) or




15.2 times greater (if only the five certain cases of lung cancer are counted).




Both observed numbers are significantly (P < 0.05) greater than expected,




however.




     Ohsaki et al. (1978) studied the incidence of lung cancer in a cohort of




67 active chromate workers and 487 retired chromate workers at a factory on




Hokkaido Island in Japan.  It is not known at this time whether this is the




same factory as was studied by Watanabe and Fukuchi (1975).  The average exposure




was 22.8 years (10 to 36 years), with 133 workers exposed for >10 years.  In




this population, the authors diagnosed 10 patients with lung cancer, and deter-




mined from death records that an additional four cases had occurred.  The




incidence of lung cancer in these chromate workers was 658 per 100,000, as




compared to 13.3 per 100,000 for the Japanese population (P < 0.01 as calculated




by the GAG).  (It is presumed that the latter rate applies to the male population,




although the authors did not state this explicitly.)  No correction was made in




this study for smoking habits, even though all but two of the individuals with




lung cancer were heavy smokers.




     Sano and Mitohara (1978) reported that of 36 deceased chromate workers in




Tokyo, 19 had died of cancer of the respiratory organs.  Although this report




merely related case histories, the authors maintained that it supported the risk




of cancer associated with the chromate industry.  Of particular interest in




this report were the total metal analyses of two workers exposed to chromium




who died of respiratory cancer.  Along with excessive levels of chromium, there




were elevated levels of nickel, cobalt, beryllium, vanadium, and manganese in




the lungs, indicating exposure to other possible carcinogens.
                                      7-64

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     Satoh et al. (1981) conducted a mortality and morbidity study of 896 workers




engaged in the manufacture of chromium compounds for one or more years during




the period 1918 to 1975 at a plant in Tokyo, Japan.  It was reported that during




the period 1934 to 1975, 84% of the chromium compounds manufactured were




hexavalent and 16% were trivalent.  The plant was closed in 1975; workers were




followed until 1978 or until death.  Data on the causes and dates of death were




collected from death certificates or other "reliable written testimony."  In




addition to the 896 workers who were followed, 165 chromium workers were not




included in the study due to a lack of "necessary information."  All of the




latter group were retired workers whose permanent residence and current status




were unknown and whose vital status as of the end of 1978 could not be determined.




Of these 165, approximately 80% had left chromium work prior to 1949, and for




65% the date of birth was unknown.  The average number of years as a chromium




worker for the 165 not included in the study was about 7 years, less than the




10-year average for the 896 workers who were included in the study.  The authors




analyzed the mortality data by four different time periods, 1918-49, 1950-59,




1960-69, 1970-78, and the overall time period 1918-78.  They reported the




observed and expected number of deaths and SMRs for various diseases, and found




that there was an excess risk of lung cancer for each of the time periods




(mortality ratio = 9.5 for the 1918-78 time period; P < 0.005).  No excess risk




of death from any other disease was found for any of the time periods or for




the overall time period.  Satoh et al. also analyzed the data by length of




working experience (1-10 years, 11-20 years, and 21+ years) for the time periods




1950-59, 1960-69, and 1970-78.  For lung cancer deaths, but not for deaths from




"all other cancers," the ratio of observed to expected deaths increased by




length of working experience.
                                     7-65

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     Satoh et al. studied morbidity by examining health insurance records for




the period from 1974 through 1977 to determine if any sickness occurred in the 81




chromium-exposed workers as compared with the 82 nonexposed workers in the plant




during that period.  The authors reported that although the numbers were small,




there was no apparent difference between the exposed and the nonexposed groups




in the number of cases for any major disease category.  It should be noted that




respiratory cancer and perforation of the septum are compensable and thus do




not appear in the health insurance records.  Three years after the end of the




chromium exposure, all 94 workers who had been exposed for 1 to 28 years (average




14.9 years) were given a complete series of liver and kidney function tests.




All values were reported to fall within the normal range characteristic of




Japanese males.




     Korallus et al. (1982) reported the lung cancer SMRs for two West German




chromate-producing plants during the period from 1948 through 1979.  The popula-




tion of North Rhineland-Westphalia was used as the comparison group in calculating




the SMRs.  The respiratory cancer SMRs for both plants,  Leverkusen and Uerdingen,




1.92 and 2.24 respectively, were both statistically significant (P < 0.05) for




the period of the study.  The authors reported that when the study period was




divided into six five-year intervals (1948-52, 1953-57,  1958-62,  1963-67,




1968-72,  1973-77) and one two-year interval (1978-79) that the respiratory




cancer SMRs for these intervals generally decreased in both plants over the




period of the study.  This decrease was rather inconsistent in the Uerdingen




plant, however.  Additionally,  three subcohorts were defined:   individuals with




beginning of exposure prior to January 1, 1948 (Group I),  individuals exposed




before and after the "change in manufacture" (the change in manufacture began




in 1948 and was completed in 1957 at Leverkusen and in 1963 at Uerdingen)




(Group II), and individuals with at least half their exposure after the






                                      7-66

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completion of the "change in manufacture" (Group III).  The "change in manufacture"




refers to the initiation of "no-lime" processing of the chrome ore—a change




which is believed to have resulted in a reduction of the carcinogen risk.  For




both plants there was a clear drop in the lung cancer SMR from Group I to Group




III.  For Uerdingen, the lung cancer SMRs were 2.76, 2.60, and 0.96 for Groups




I, II, and III.  For Leverkusen, the corresponding lung cancer SMRs were 2.85,




1.97, and 0.54.  In neither the Leverkusen plant nor the Uerdingen plant,




however, were the SMRs for Groups I, II, or III significantly different (P <




0.05) from each other.  Thus, the decrease in the respiratory cancer SMR from




Groups I to III might be due to chance.  A reduction in nasal perforations,




symptomatic of chromium exposure, was also observed for Groups I to III.  This




latter finding is statistically significant for both plants at P < 0.05 (chi




square test for linear trend in proportions), and would support a conclusion of




a decrease in chromium exposure from Group I to Group III.






     7.2.2.2.  CHROME PIGMENT WORKERS — Two morcalicy studies in which workers




were exposed only to hexavalent chromium have been conducted in the chrome pigment




industry.  Langard and Norseth (1975) reported on three pigment plants in Norway




that were in operation between 1948 and 1972.  One of the plants, however, was




brought on line only in 1972, the year the study ended.  Between these dates,




133 workers were identified as being employed at the three plants.  Of the 133,




24 had been employed >3 years, and of this cohort, six cases of cancer (three




of lung cancer and one of gastrointestinal cancer) were identified through the




Cancer Registry of Norway.  All three of the lung cancer cases had been employed




5 years or longer.  Two other cases, one with prostate cancer and one with




nasal cancer, were identified among the 133 workers.  These cases did not




qualify for membership in the cohort employed for >3 years, however.  Data from
                                      7-67

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the Cancer Registry indicated an expected number of lung cancer cases among




those employed of 0.079; thus, the observed number of cases was 38 times that




expected.  Exposure levels as determined by personal monitoring were reported




for the plants for the year 1972, the year in which the study ended, with




chromium levels in the two older plants ranging between 0.04 and 1.35 mg/m-',




and levels in the new plant between 0.01 and 0.08 mg/m^.  The distribution of




the number of employees per year was not presented, although it was indicated




tht only seven or eight employees worked in the plants between 1948 and 1950,




with this number increasing slowly to a level of 30 workers by 1972.  Although




an increased risk of lung cancer was indicated, two of the individuals with




lung cancer were moderate to heavy smokers.  Nevertheless, a relative risk of




lung cancer of 38 would not be explained by differences in smoking between the




study cohort and the Norwegian population.




     Davies (1978, 1979) studied three chromate pigment plants in England,  of




which plants A and B produced both zinc and lead chromate, while plant C produced




only lead chromate.  The cohort of exposed workers consisted of employees with XI




year of service,  who were first hired between 1933 and 1967 for plant A, 1948




through 1967 for plant B, and 1946 through 1961 for plant C (these years were




governed by the availability of complete employment records), and for whom




vital statistics  were available as of 1977.  Using these guidelines, 396, 136,




and 114 subjects  were obtained from plants A, B, and C, respectively.  These




groups were further subdivided into high and medium exposure and low exposure




group's.  The observed mortality from lung cancer in the different plants by




exposure category was compared to the expected mortality as calculated from




national lung cancer mortality rates for all males in England and Wales.  These




data are presented in Table 7-16.  The exposure categories of high and medium




were combined, the author stated, because they were "similar."  No details






                                      7-68

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                       TABLE 7-16.   LUNG  CANCER IN WORKERS  IN THE  CHROMATE PIGMENT  INDUSTRY
                                                  (Davies  1979)


Plant and year of
initial employment
Plant
71 1932
S 1955
Plant
1948
Plant
1946
A
- 1954
- 1967a
B
- 1967
C
- 1967
High and medium
exposure
Number of Observed Expected
men lung cancer lung cancer

175 18b
62 0

116 7C

95 1

8.17
1.14

1.43

2.46
Low exposure
Number of Observed
men lung cancer

77 2
14 0

20 0

19 1

Expected
lung cancer

2
0.16

0.1

0.37
aPlant modification in Plant A in 1955  considerably  reduced  employee  exposure  to chromates.  Thus, results
 were divided into two time periods,  1932-54  and  1955-67,  for  the  purpose  of analysis.
bP < 0.01.
CP < 0.001.

-------
were given in this regard, but it is presumed the author meant that the




categories were similar with regard to the ratios of observed to expected lung




cancer deaths.  Adjustments to the expected number of lung cancer death values




were made in the following manner:  (1) the expected number of lung cancer




cases was adjusted upward because the proportion of unskilled and semiskilled




workers in the study population was higher than in the general population, and




these persons are known to smoke more than the national average; (2) the expected




number was adjusted downward for plant B and upward for plant C to reflect the




respective differences in local lung cancer mortality in comparison to the




national lung cancer mortality.  The author did not state how these adjustments




were calculated.  An elevated risk of lung cancer was present only in the com-




bined high and medium exposure group in plants A and B, while plant C, which




manufacture^ .only lead chromate,  showed no elevated risk.  Also, workers in




plant A who had been hired after production modification in 1955 showed no




increased risk of lung cancer,  even though there was a minimum followup period




of 15 years.  The authors suggested that these data indicate that zinc chromate




was associated with the etiology of lung cancer, while lead chromate was not,




and although the data were limited by the small sample size, the authors claim




that engineering controls had effectively lowered the risk of lung cancer in




plant A.




     Frentzel-Beyme (1983) reported that the observed number of lung cancer




deaths exceeded those expected  among workers in five chromate pigment plants in




the Netherlands and West Germany.   In only one factory, however,  was this excess




statistically significant.  The authors did not find a lung cancer mortality




dose-response by intensity of exposure or duration of exposure.   The numbers of




deaths in each exposure category  were rather small, however.
                                      7-70

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     7.2.2.3.  CHROME PLATING WORKERS — Royle (1975) studied mortality in




the chromium plating industry of England in a retrospective study between 1969




and 1972, and also reported on the first 2 years of a prospective study that




began in 1972.  Workers in this industry are exposed to hexavalent chromium in




the form of chromic acid mist and some sodium dichromate dust.  In the retro-




spective study, 1,238 chrome plating workers employed for >3 months were traced




along with 1,284 manual laborers used as controls.  The control subjects were




matched to the exposed workers for sex and the last date they were known to be




alive, while the subgroup of workers who were currently employed in the chrome




plating industry were also matched for smoking habits.  Similar success was




achieved in tracing both groups, and from the response to questionnaires, there




was little difference in the smoking habits of the groups.  The death rate was




higher in the chrome plating group, with 109 deaths observed as compared to 85




in the control group.  In examing cause-specific deaths, there was a significant




(P < 0.05) difference in the death rate for cancer at all sites, 3.15% in chrome




platers as compared to 1.63% in controls; while deaths from malignancy of the




lung and from malignancy of the gastrointestinal tract were each increased,




although not significantly.  Other causes of death were similar in the two




groups.  In a small group (220 subjects) with high exposure, there was greater




mortality associated with employment of 1 year or more as compared with exposure




for less than 1 year.  The results of the first 2 years of the prospective




study indicate an increased proportionate cancer mortality with 12 cancer deaths




(the tables indicate 12, although the text reports 9) of 33 deaths reported in




the chrome-exposed group, compared with 3 cancer deaths of 19 deaths in the




control group.




     In addition to the mortality study, Royle also conducted a morbidity study




of the chrome plating workers.  The controls were the same as those in the






                                      7-71

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mortality study.  The author stated that detailed results of the morbidity




study would be published in a separate article.  Among platers, it was reported




that there was a significant increase in the prevalence of a large majority of




different respiratory symptoms.  The possible causes of this increase were




examined in some detail.  In the course of the investigation, it was found




that a significantly larger proportion of controls (8.3%, 93 controls) than




platers (3.6%, 36 platers) had been engaged in asbestos processing.  Thus, the




risk of lung cancer due to chromium exposure in platers as compared to that of




the controls may have been underestimated.  The results of this study were




inconclusive because of the relatively short (3-year) follow-up period in this




retrospective study, and because results from the prospective study are only




preliminary.




     Okubo and Tsuchiya (1979) conducted a cohort study of 889 Tokyo chrome




platers, with an unspecified number of controls selected from the same factories




as the chromium platers.  The follow-up period was April 1,  1970 to September




30, 1976.  Vital statistics were ascertained using the records of the Tokyo




Health Insurance Society of the Plating Industry.  The type  of work and chromium




exposure history of the members of this society were investigated by means of a




questionnaire sent to the manager of each factory.  The recovery rate of the




questionnaire was 70.5%.  Survival information on retired subjects was obtained




from the offices of the Japanese family registration system.  Among the 889




male chromium platers,  19 deaths were observed, or about 50% of those expected.




The expected number of  deaths was calculated using the annual male mortality




rates,, by age, for Tokyo.  In contrast, the authors reported a slightly higher




percentage of deaths in the control group.




     The authors noted  that two possible types of error may  have occurred in




this study:   1)  deaths  from the chromium group may have been incorrectly assigned






                                      7-72

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to the control group, and 2) the 30% who were nonresponders may have represented




a significant number of factories in which chromium-related deaths occurred.




     In addition to the problems noted by the authors, the follow-up period for




this study, six years, was probably not long enough to be able to detect




differences in lung cancer mortality resulting from chromium exposure.  Also,




the size of the cohort, 889, was relatively small for the detection of significant




differences in lung cancer mortality.




     Silverstein et al. (1981) found a statistically significant increase (P <




0.001) in the lung cancer proportionate mortality ratios for both male and




female white employees in a die-casting and electroplating plant.  In this




plant, workers were exposed to chromium during electroplating, but nickel and




copper were also used in electroplating.  The other operations of the plant were




zinc alloy die-casting and buffing, polishing, and cleaning of zinc and steel




parts.  Because of the employees' exposure to other potential carcinogens, no




conclusion can be made from this study regarding the association of chromium




electroplating and lung cancer mortality.






     7.2.2.4.  FERROCHROMIUM WORKERS — Pokrovskaya and Shabynina (1973)




studied cancer mortality among workers at a chromium ferroalloy plant in the




Soviet Union for the period 1955-1969.  Deaths among the workers were identifed




through the archives of the city registrar's office.  Age-specific mortality




rates for the plant employees were compared with the corresponding age-specific




mortality rates for persons in the city where the plant was located.  Persons




who were exposed to chromium in other occupational settings were excluded from




the comparison group.




     Workers in the plant were reported to be exposed to low-solubility chromium




compounds.  The valence of the chromium and the characteristics of the chromium
                                      7-73

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 exposure (dust  or  aerosol) varied  throughout  the different  sections  of  the  plant.

 The  greatest  concentration of  chromium in  the air was noted during the  smelting

 of refined  ferrochromium.  In  addition to  chromium,  the authors  reported  that

 large  amounts of "tarry  substances" entered the work area,  together  with  furnace

 gases,  during the  smelting process.  These substances included benzo[a]pyrene,

 which  is formed during the caking  of the electrode mass.  The highest concentrations

 of tarry substances were observed  at the work stations of electrode  workers; a

 significantly lower concentration  was  observed at the work stations  of  smelters

 and  batchers.

     The mortality ratios for  cancer of all sites and for lung,  stomach,  and

 esophageal  cancer  for the ferroalloy production workers are reported in Table

 7-17.
      TABLE 7-17.  MORTALITY RATIOS RESULTING FROM MALIGNANT TUMORS AMONG
                   WORKERS IN CHROMIUM FERROALLOY PRODUCTION
                 (adapted from Pokrovskaya and Shabynina 1973)
                            Relative risks of cancer mortality

                 All sites           Lungs           Stomach
Esophagus
Age groups
30-39
40-49
50-59
60-69
Males
2.6
0.5
3.3a
2.0
Females Males Females Males Females Males Females
2.8 4.4 - 3.8 -
1.3 - - 0.8 4.0
7.9 6.6a - 3.2 - 2.0a
- - - - 11.3a
aP=0.001.
As can be seen from the table, the mortality ratio for all malignant tumors was

higher for the ferroally workers in almost all age groups of both sexes.  The


                                      7-74

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 mortality  ratio  (MR)  for lung  cancer was  significantly  higher (MR =  6.6,  P  - 0.001)




 among  males  in the  50-59 year  age  group and  was  4.4  among  males  in the  30-39




 year age group.   (The statistical  significance of  this  latter mortality ratio




 was not reported.)  The  mortality  ratio for  esophageal  cancer was  significantly




 higher (P  =  0.001)  among males  in  the  50-59  and  60-69 year age groups (RR =  2.0




 and 11.3,  respectively).




     The average  age  of  workers  in ferrochromium production who  died of cancer




 was reported  to be  significantly lower than  that of  the  city  residents  who died




 of cancer—49.4 and 62.9 years, respectively.  A higher  level of cancer mortality




 was also reported among  workers subjected  to the greatest  dust load  (charge




 loaders, metal breakers,  and smelters).  The authors reported a high mortality




 rate from  cancer  among workers  in  the  charge preparing and  finishing sections,




 where  high chromium-containing  dust  pollution was observed  but no  exposure to




 benzo[a]pyrene was  found.  This study  appears to be merely  a  comparison of




 cancer mortality between the ferroalloy plant workers and  the  local population




 for the time  period 1955-1969.  Very little detail was provided by the authors.




 No cohort was defined.   The number of  person-years and the  number  of cancer cases




 among  the ferroalloy workers were not  reported; nor were the  number of cases and




 and the number of individuals in the comparison population.   Because of the




 sketchiness of the reporting and the lack of an adequately  defined cohort, the




 results of this study are open to question.  In addition, if  a high turnover




 rate existed among employees of the plant, the results of the study could be




misleading.




     Langard et al.  (1980) studied  ferrochronu'iini workers at a  ferrochromium




plant in Norway who were predominantly exposed to trivalent chromium.  In an




 industrial  hygiene study of the plant  in 1975,  ambient chromium levels of




between 0.01 and  1.34  mg/m^ were detected  in the ferrochromium department, and,






                                      7-75

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of this chromium, it was determined that 11% to 33% was hexavalent.  The study




consisted of 976 employees who had worked for >1 year, were alive after 1953,




and had been initially employed prior to 1960.  The study was divided into 10




subgroups by job description, with only 325 subjects specifically associated




with ferrochromium production and considered exposed to chromium.  Comparison




of cancer incidence for all sites and for different sites were made between the




Norwegian male population and the ferrochromium worker population, using the




Norwegian Cancer Registry.  Foisson distribution was used to test for statistical




significance.  A comparison of total mortality was also made.  Of the 10 job-




related subgroups, only the ferrochromium workers had a significant difference




between the observed and expected number of "lung" cancer cases (7 observed




versus 3.1 expected, P < 0.05).  (Note:  The statistical significance was calculated




by Langard et al. to be P = 0.08.  The GAG tested the difference using the Poisson




distribution, and found the significance to be P < 0.05).  There is a problem




with the authors' use of the term "lung cancer."  Although the authors primarily




refer to "lung cancer" in the text, they also use the terms "cancer of the




respiratory tract" and describe the "lung cancer" cases in one of the tables as




being of International Classification of Disease (ICD) codes 162 and 163.  ICD




codes 162 and 163 include cancer of the respiratory tract other than lung




cancer.  This ambiguity raises some question as to the authors'  comparisons of




observed and expected cases.  If the expected number of cases is calculated for




ICD codes 162 and 163, and the observed number of cases are only lung cancer




cases',  then the relative risk of lung cancer has been underestimated.  If the




opposite is true, then the risk has been overestimated.  If the observed number




of "lung cancer" cases mistakenly includes cases of tnesothelioma,  then the




stated  "lung cancer" risk due to chromium may instead be a reflection, at least
                                      7-76

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partially, of asbestos exposure.  This ambiguity must therefore be considered




when interpreting the results.




     Total mortality and cancer incidence at all sites were similar to the




general population.  The relative risk of "lung cancer" among the ferrochromium




workers as compared to the Norwegian male population may have been underestimated,




however, since the county in which the plant was located, Hordaland, had an age-




adjusted "lung cancer" incidence that was 58% of Norway's "lung cancer" incidence




rate.  If this 58% is multiplied by the expected number of "lung cancer" cases




calculated from national rates, the newly calculated expected number differs




significantly from the observed number of cases (P < 0.01).  If non-chromium-




exposed workers in this plant had been used as a control population, the risk




of "lung cancer" in chromium-exposed workers would have increased to 8.5, which




is significant at P < 0.01.  The ferrochromium workers were possibly exposed to




two other carcinogens, asbestos and polycyclic aromatic hydrocarbons; however,




this was unlikely to have been an important factor, the authors indicated, since




a group of 243 ferrosilicon workers in the same plants were believed to have been




exposed to these two known carcinogens to the same degree, and no increased




risk of "lung cancer" (0 observed and 2.78 expected) was observed among these




workers.  However, the sample size for the ferrosilicon workers (number = 243)




would have to be considered too small to be able to detect any significant




excess of "lung cancer."




     In studies of the ferrochromium industry in Sweden, Axelsson et al. (1980)




concluded that there was no association between employment in the ferrochromium




industry and risk of respiratory cancer.   The study cohort consisted of 1,876




men who had been employed for one or more years between 1930 and 1975,  and who




were alive as of 1951.  Observed cases were included for comparison if  they




occurred 15 years after first exposure.  The exposed population was compared






                                      7-77

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with males in the county in which the plant was located, and comparisons were




tested for significance by two-sided P-values using the Poisson distribution.




The workers were subdivided into four groups consisting of arc-furnace workers;




workers in transport, metal grinding, and sampling; maintenance workers; and




office workers.  It was estimated that these groups had been respectively




exposed to 2.5, 0.5 to 2.5, 2.5, and 0 mg/rn^ of trivalent chromium and elemental




chromium,  and 0.25, 0.01 to 0.05, 0.05, and 0 mg/m^ of hexavalent chromium,




respectively.  Medical examination of employees during the last 3 years of the




study detected three cases of perforated septum of the nose, suggesting that




some exposure to hexavalent chromium had occurred in at least a portion of the




work force.  No statistically significant difference in cancer mortality between




that observed in the workers and that expected based on national mortality data




was found.  The only significant increase in cancer incidence was an increase




in respiratory cancer (4 observed and 1 expected, P = 0.038) in the 315 maintenance




workers.   Of the four cases of respiratory cancer,  two were diagnosed as meso-




theliomas, and the authors suggested that these cases may have resulted from




exposure to asbestos.  It was also noted that the control population was mainly




rural dwellers, while the exposed group consisted of urban dwellers, and that




rural residents in Sweden generally smoked less.   From the results of this




study, the authors concluded that no association existed between exposure to




predominantly trivalent chromium and elemental chromium and the development  of




cancer.  Because of the confounding effects of smoking and exposure to asbestos,




no definite conclusions can be drawn from this study.
                                      7-78

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 7.2.3.  Quantitative Estimation.   This  quantitative  section deal            t,
                                                                            v

 risk for chromium  in air and  the  potency of  chromium relative  to            H


 gens that  the GAG  has  evaluated.   The unit risk  estimate  for an


 is defined as the  incremental lifetime  cancer  risk over the back,


 in a hypothetical  population  in which all individuals  are  exposed  continuously


 to a concentration of  1 ug/m3 of  the agent in  the air  that  they breathe.  This


 calculation  is done to estimate in quantitative  terms  the  impact of  the agent


 as a carcinogen.   Unit risk estimates are used for two purposes: 1)  to compare


 the carcinogenic potency of several agents with  each other,  and 2) to give  a


 crude indication of the population risk which might  be associated with exposure


 to these agents, if the actual exposures are known.


     The data used for quantitative estimation can be of two types:  1)


 lifetime animal studies, and  2) human studies where  excess  cancer  risk has  been


 associated with exposure to the agent.  It is assumed, unless evidence exists


 to the contrary, that  if a carcinogenic response occures at  the dose levels


 used in a study, then responses will also occur at all lower doses, with an


 incidence determined by an extrapolation model.


     There is no solid scientific  basis for any mathematical extrapolation


 model that relates carcinogen  exposure to cancer risks at the extremely low


 concentrations that must be dealt with in evaluating environmental hazards.


 For practical reasons such low levels of risk cannot be measured directly either


 by animal experiments or by epidemiologic studies.  We must, therefore, depend


 on our current understanding of the mechanisms of carcinogenesis for guidance


as to which risk model to use.  At the present time the dominant view of the


 carcinogenic process involves  the  concept that most cancer-causing agents


also cause irreversible damage to DNA.  This  position is reflected by the fact


 that a very large proportion of agents that cause cancer are also mutagenic.



                                      7-79

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     A  is  reason to  expect  that  the quantal  type of biological  response,  which




 is  characteristic of mutagenesis, is  associated with  a  linear  non-threshold




 dose-response  relationship.   Indeed,  there  is substantial evidence  from




 mutagenesis  studies with both ionizing  radiation and  a  wide variety of chemicals




 that this type  of dose-response model is  the appropriate one to use.  This is




 particularly true at the lower end of the dose-response curve; at higher doses,




 there  can be an upward curvature, probably  reflecting the effects of multistage




 processes on the mutagenic response.  The low-dose linearity and nonthreshold




 dose-response  relationship is also consistent with the  relatively few epidemiologic




 studies of cancer responses to specific agents that contain enough  information




 to  make the  evaluation possible (e.g., radiation-induced leukemia,  breast and




 thyroid cancer,  skin cancer induced by arsenic in drinking water, liver cancer




 induced by aflatoxins in the  diet).  There  is also some evidence from animal




 experiments  that is consistent with the linear nonthreshold model (e.g., the




 initiation stage of the two-stage carcinogenesis model in rat liver and mouse skin).




     Because its scientific basis, although limited,  is the best of any of the




 current mathematical extrapolation models, the linear nonthreshold model has




 been adopted as  the primary basis for risk extrapolation to low levels of the




 dose-response relationship.




 '    The  quantitative aspect  of carcinogen risk assessment is included here




 because it may be of use in the regulatory decision-making process,  e.g.,




 setting regulatory priorities, evaluating the adequacy of technology-based




 controls,  etc.   However, it should be recognized that the estimation of cancer




 risks to humans at low levels of exposure is uncertain.   At best,  the low-dose




 linearity extrapolation model used here provides a rough but plausible estimate




 of the upper limit of risk; i.e.,  it is not  likely that  the true risk would be




much more  than the estimated risk, but it could  very  well be considerably lower.






                                      7-80

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The risk estimates presented below should not be regarded as accurate representa-




tions of the true cancer risks even when the exposures are accurately defined.




The estimates presented may, however, be factored into regulatory decisions to




the extent that the concept of upper risk limits is found to be useful.        ^___




     There are many epidemiologic studies demonstrating that hcxavalent chromium




(Cr VI) is a potential human carcinogen, but few of these studies provide adequate




exposure data for use in risk estimation.  One study by Mancuso (1975) provides




what the GAG feels is limited but adequate information for this purpose, however.




Mancuso1s data is used as the main data base for estimating the carcinogenic




potency of hexavalent chromium.  For comparison, data from three foreign studies




on ferrochromium plants are also used in the potency calculations.  From the




quantitative risk assessment viewpoint, these studies are less adequate than




the Mancuso study.  For the Norwegian study (Langard et al. 1980), the exposure




measurements were taken in 1975, while some workers could have been exposed to




chromium as early as 1928, when the ambient dust levels were much higher than




in recent years.  For the Swedish study (Axelcson et al. 1980), the chromium-




exposed workers did not show a significant increase of lung cancer, and thus




only the statistical upper bound of the response can be used in potency estimation.




For the above reasons, it is expected that the use of data from the Norwegian




and Swedish studies would result in an overestimation of the true carcinogenic




potency of hexavalent chromium.  While the Russian study (Pokrovskaya and




Shabynina 1973), does not have the deficiencies of the other two foreign studies,




the cohort in this study is not well defined,  and thus the validity of the data




reported is open to question.  In an effort to provide alternative potency




estimates, the data from these less adequate studies have also been used by the




CAG to calculate the potency of hexavalent chromium.  The potency calculated on




the basis of Mancuso1s data is consistently smaller than (but within 5 folds of




magnitude of) the lower-limit estimates calculated from the three foreign studies.






                                      7-81

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     Animal data from intratracheal studies have not been used to estimate the




carcinogenic potency of chromium by inhalation because there is no pharmacokinetic




information relating the distribution of chromium to lung tissues by inhalation




and by intratracheal administration.  This information is needed because the




dose distribution is clearly different between these two exposure patterns.




Furthermore, the physiological mechanism of dose distribution by intratracheal




administration may depend (in a non-linear fashion) on the dose levels used in




the experiment, as evidenced by the observation that a single administration of




sodium dichromate induced a carcinogenic response in Sprague-Dawley rats but




failed to induce a response when the same weekly dose was given over 5 days.






     7.2.3.1.  ESTIMATION OF THE CARCINOGENIC PPTENCY OF HEXAVALENT CHROMIUM




(Cr VI) BASED ON THE MANCUSO (1975) DATA -- The Mancuso study was based on a




cohort of 332 white male workers who were employed in a chromate plant between




1931 (when the plant began to operate) and 1937, and who were followed to 1974.




In his study, Mancuso reported lung cancer death rates by levels of exposure to




soluble, insoluble, and total chromium concentrations.  Because only lung




cancer mortality for total chromium exposure was reported by age group, the GAG




has used only the dose-response data for total chromium to estimate the carcino-




genic potency of hexavalent chromium.  Although the use of dose-response data




for total chromium will result in an underestimation of the potency of hexavalent




chromium, we believe that the effect of this underestimation is approximately




compensated for by other factors that may overestimate the risk.  These issues




will be discussed further in the pages that follow.




     Exposure information in the Mancuso study was derived from an industrial




hygiene study of the plant conducted in 1949.  In this study, time-weighted




averages of exposure to insoluble, soluble, and total chromium per cubic meter
                                      7-82

-------
were calculated  for each occupation and for each worker  in every department.




Using these data and company personnel records, Mancuso  was able to calculate




an estimate of exposure to soluble, insoluble, and total chromium by duration




of exposure (in mg/nH-years) for each member of the 1931-37 cohort.  In 1949,




after the industrial hygiene study had been conducted, the company initiated a




comprehensive program designed to reduce employees' exposures and improve




manufacturing efficiency.  Until that time, however, the company had not under-




taken any programs for the purpose of reducing employee  exposure.  It should be




noted, however, that Bourne and Yee (1950), who conducted the industrial hygiene




survey in 1949, reported that "in order to meet price and quality competition,




improvements in equipment and processes have been made periodically during the




past 18 years, and it is the universal experience of industrial hygiene personnel




that greater process efficiency is almost invariably associated with a more




healthful working environment.  Therefore, there seems little doubt that




atmospheric contamination in the past was greater than in 1949."  Nonetheless,




no concerted effort was made to reduce employee exposure until late in 1949,




and because this particular plant was a relatively modern one at the time of




the industrial hygiene survey,  it is unlikely that improvements in efficiency




over the period 1931 to 1949 would have reduced employee exposure to a great




extent.   Thus, the GAG considers Mancuso"s data to be a reasonable approximation




of what workers in the study cohort were exposed to during their entire working




history.   The  GAG recognizes the possibility that  the exposure may be slightly




underestimated because of the likelihood that a greater proportion of the




"total exposure" was contributed prior to 1949 than post-1949.




     The  effects of underestimating the exposure concentration,  as well as the




effects  of other uncertainties  on the estimation of potency,  will be addressed in




the Discussion section.
                                      7-83

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     7.2.3.1.1.  Data Available for Potency Calculations — Table 7-18,


which is taken directly from Mancuso (1975), presents age-specific lung cancer


deaths, corresponding person-years, and range of exposures to total chromium.


     To estimate the lifetime cancer risk due to exposure to chromium, it is


assumed that an exposure, D (rag/m^ -years) ,  as presented in Table 7-18, is


equivalent to the continuous exposure d (ug/nr) calculated by
x _i  x 240 x 103 Ug/m3
                             _P
                             fLe   24    365
where Le is the midrange in each age category, f is the fraction of time in age


exposed, and 8/24 and 240/365 are the fractions of a day and year, respectively,

                                                              o
that a worker spent at the plant.  For instance, if D = 8 mg/m -years, Lg = 60,


and f = 0.65, then d = 44.96 ug/m3.  The assumption of f « 0.65 implies that


the cohort exposure to chromium began approximately at age 20.  The assumption


is that the particular exposure pattern (unknown to us) leading to the cancer


mortality rates as observed is equivalent to the continuous constant exposure


starting from the age when exposure began.  This assumption may or may not be


realistic.  However, it would be more unrealistic to make a different assumption


concerning the exposure pattern when all that is given is an exposure which


itself was calculated by taking the weighted average of the duration of exposure


for each respective job the worker had.


     Since the person-year in each category presented in Table 7-18 is very


small, the exposure categories are combined as shown in Table 7-19 to increase


statistical stability.  The last column of Table 7-19 is given for the purpose


of identifying which exposure categories in Table 7-18 are combined.  The


midrange of age and exposure concentration is used in Table 7-19.  Data in this


table are used to estimate the lifetime cancer risk due to chromium exposure.
                                      7-84

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                   TABLE  7-18.  AGE-SPECIFIC LUNG CANCER DEATHS AND GRADIENT EXPOSURES TO TOTAL CHROMIUM

                                                     (Mancuso 1975)
    Age
<1.00
      Exposure to total chromium (mg/m^-year)


1.0-1.99      2.0-3.99      4.0-5.99      6.0-6.99
                                         7.0-7.99
                                         8+a
    45-54      Deaths
i
00
Ln
              Person-years
 886
 459
583
348
159
140
262
    55-64      Deaths
              Person-years      707
              356
               462
              250
              113
               98
            203
    65-74      Deaths
              Person-years      235
              166
               182
               80
               42
               41
             81
    aData in the  last  column  are not used in the CAG1s risk assessment because the range of exposure in this class is

     not  known, and  it does not appear reasonable to assume that all three age groups had an identical exposure

     distribution in this  class.

-------
                TABLE  7-19.   COMBINED AGE-SPECIFIC LUNG CANCER DEATH RATES AND TOTAL CHROMIUM EXPOSURE (in ug/m3)
I
oo
Age
50
50
50
60
60
60
70
70
Concentration
(ug/m3)a
5.66
25.27
46.83
4.68
20.79
39.08
4.41
21.29
Deaths
3
6
6
4
5
5
2
4
Person-years
1345
931
299
1063
712
211
401
345
Background
rateb
6.05
6.05
6.05
1.44
1.44
1.44
1.57
1.57
x 10"4
x 10"4
x 10"4
x 10~3
x 10~3
x 10~3
x 10~3
x 10~3
Exposure range as presented
in Table 7-18
<_ 1
2.0
6.0
<_ 1
2.0
6.0
_< 1
2.0
.99
- 5.99
- 7.99
.99
- 5.99
- 7.99
.99
- 7.99
           formula described  in  the section "Data Available for Potency Calculations."  The concentrations presented
           in  this table are  the averages of several exposure categories weighted by corresponding person-years.
         ^Background  rate  is estimated from 1964 U.S. Vital Statistics.  The year 1964 is selected because it is
           estimated that a large proportion of lung cancer deaths occurred during that year.

-------
      7.2.3.1.2.   Choice  of Dose-Response  Model  — It  has  been widely recognized


 (e.g.,  Doll  1971)  that the age-specific incidence curve  tends to be  linear on


 doubly  logarithmic graphs, or equivalently,  the age-specific  incidence  follows  the

 mathematical form
 where b  and k  are  parameters  that may be  related  to  other  factors  such  as  dose,


 and  T may be one of  the  following three cases:


     1.  T is  age  when cancer  is observed,


     2.  T is  the  time from the first exposure  to observed cancer, or


     3.  T is  the  time from exposure to cancer  minus the minimum time for  a
         cancer to be clinically recognized.


     This model has  been shown to arise from the  somatic mutation  hypothesis of


 carcinogenesis (Armitage and Doll 1954, Whittemore 1978, Whittemore and Keller


 1978).   It has also  been shown to arise from the  epigenetic hypothesis when the


 reversible cellular  change is programmed to occur randomly (Watson 1977).


 These authors and many others have used this model to interpret and/or estimate

 potency  from human data.


     Since the data  that could be used for risk estimation are limited,  a  simple

 model that fits the  data should be used.  Therefore, the observed age-specific

 incidence is assumed to follow the model



                             I(t,d)  = B(t) + h(t,d)



 where B(t)  is the background rate at age t and  h(t,d) = Q(d)  tk-1  with

                r\
 Q(d)  = q^d + q2d  ,  a function of dose d.


     Once the parameters  qi ,  q2 ,  and k are estimated, the lifetime cancer risk


 associated  with an exposure d by age t,  taking  into  account the competing risk,

can be  calculated  by


                                      7-87

-------
                               t               S
                     P(t,d) =  f h(s,d)exp r-[ f h(y,d)dy + A(s)] Ids
                              oo


where exp[-A(s)] is the probability of surviving to age s and h(t,d) =

I(t,d) - B(t), the age-specific incidence after adjusting the background rate.


     7.2.3.1.3.  Estimation of the Risk Model — To estimate the parameters in

h(t,d) we assume, as is usually done, that the number of lung cancer deaths, X,

at age t, follows the Poisson distribution with the expected value


                           E(X) = N x (B + Q(d) tk-1)


where N is the person-year associated with X, B is the background rate at age
                       f\
t, and Q(d) = q^d + q2d .

     Using the BMDP computer program P3R and the theory relating the maximum

likelihood and non-linear least square estimation by Jennrich and Moore (1975),

the parameters qj,  q2,  and k are estimated by the method of maximum likelihood

                 —7                —9
as q1 = 1.11 x 10  ,  q2 = 1.84 x 10  , and k » 2.915; the corresponding standard

deviations are respectively 7.8 x 10~7,  1.2x10"^,  and 1.7.

     Thus, the age-specific cancer death incidence at age t due to chromium

exposure d ug/m^ is given by


                              h(t,d)  = Q(d)  tl-915


where

                      Q(d) = 1.11  x 10~7d +  1.84 x 10~9d2


     The model fits the data well,  as can be  seen from the  goodness  of fit

statistic


                              X2  =  j. (0-E)2/E =1.60
                                      7-88

-------
which has, asymptotically,  a chi-square distribution with 5 degrees of freedom

under the model specified.   The observed and predicted values used in calculating

X2 are (3, 2.5), (6, 7.2),  (6, 5.1), (4, 3.1), (5,  6.7),  (5, 4.1), (2, 1.4)

and (4, 4.3).

     Taking into account the competing risk, the lifetime probability of lung

cancer death due to exposure to chromium d ug/m3 is given by

                          L
                P(L,d) =  / h(t,d)exp |-[(Q(d)/2.915) t2«915 + A(t)]  }dt
                         o

where L is the maximum human lifetime and is mathematically equivalent to

infinity, since the probability of surviving beyond L is  0.

     At low doses, approximately,


                              P(L,d) = d x P(L,1)


where P(L,1) is the lifetime cancer risk due to exposure  to 1 ug/m3 of

chromium.  The unit risk, P(L,1), has been adopted  by the GAG as an indicator

of the carcinogenic potency of a chemical compound.


     7.2.3.1.4.  Calculation of the Risk at 1 ug/m3 — To calculate the unit

risk, P(L,1), it is necessary to know exp[-A(t)], the probability of surviving

to age t.  Since this probability can only be estimated,  it is assumed that  the

survival probability is constant over a 5-year interval,  as provided in the  U.S.

Vital Statistics.

     Using this approximation and by integrating the formula P(L,1),  we have


P(L,1). =  £[exp(-3.87 x 10~8 t^2*915) - exp(-3.87 x 10~8ti2*915) ] x P£

       - 1.16 x ID"2


where (t^_j, t^) is a 5-year interval and P£ is the probability of survival  up
                                      7-89

-------
to the age t£_i.  P£ is assumed to be a constant over the interval and is




estimated from the 1975 U.S. Vital Statistics.






     7.2.3.1.5.  Alternative (Crude) Approach for Calculating the Carcinogenic




Potency of Chromium from the Mancuso (1975) Data — As a crude approximation, the




carcinogenic potency of chromium can be calculated by B = (R-l) x P0/d, where




PQ = 0.036 is the estimated lung cancer mortality rate for the U.S. population,




R is the relative risk of the lung cancer deaths in the cohort, and d is the




"standardized" lifetime dose concentration to which the workers were assumed to




be exposed.  This approach is used by the GAG to calculate carcinogenic potency




when the only data available are the relative risk estimate and an average




exposure concentration.




     For the Mancuso (1975) data, the relative risk R and the "standardized"




dose d are estimated respectively to be R = 7.2 and d = 15.5 ug/m3.  They are




calculated by combining the relative risks and dose concentrations in each of




the age-exposure categories, weighted by the relative magnitude of person-years,




as shown in Table 7-19.




     Therefore, the carcinogenic potency of hexavalent chromium (Cr VI) is




estimated to be






                 B = (7.2-1) x 0.036/15.5 = 1.4 x 10-2/ug/m3.






This crude estimate is only slightly higher than the previous estimate,




1.2 x 10-2/ug/m3.






     7.2.3.1.6.  Discussion — The following discussion is intended to provide




some insight about the uncertainties of estimating the carcinogenic potency of




hexavalent chromium on the basis of the Mancuso (1975) data.




     1.  As noted previously, the risk of hexavalent chromium is estimated on




the basis of the total chromium obtained from all the soluble and insoluble






                                      7-90

-------
chromium to which workers were exposed.   Since only some  compounds of hexavale..
 chromium are^known  to be carcinogenic, the potency presented above is  likely  to




 be underestimated.   This underestimation seems unlikely to be more than sevenfold




 (or smaller) on the  basis of Bourne and Yee  (1950).  Bourne and Yee reported




 that the ratios of  trivalent chromium  (Cr III) and hexavalent chromium (Cr VI)




 concentrations in the airborne dust in nine major departments in the plant




 ranged from 1 to 3 except for two departments where the ratios were 6  for the




 lime and ash operation and 52 for the ore preparation.  Excluding the ore




 operation, the maximum ratio of trivalent chromium and hexavalent chromium is




 6, and thus the underestimation of the risk would not be more than sevenfold.




     2.  As indicated previously, there is a possibility that the use of 1949




 hygiene data may result in a slight underestimation of what workers were actually




 exposed to.  However, because the plant was relatively modern at that time, the




 underestimation is unlikely to be very considerable.  If an underestimation of




 2 times were assumed, then the unit risk would be reduced from 1.2 x 10~^/ug/m^




 to 6.0 x 10~3/ug/m3.




     3.  The risk presented in the present report may be somewhat overestimated in




 the sense that it is implicitly assumed that the smoking habits of chromate workers




 were similar to the general white male population,  while it is generally accepted




 that the proportion of smokers is higher for industrial workers (thus the higher




background incidence rates)  than for the general population.   As a sample




calculation,  it was found that if the  background rate of lung cancer mortality for




 the cohort in Table 7-19 is increased  by 40%, then the corresponding unit risk




would be reduced by about 25%,  or from 1.2 x 10"^ to 8.7 x 10~3.




     The background age-specific rate  of lung cancer at ages  50, 60,  and 70




could be 40%  more than those presented in Table  7-19,  should  it be assumed that




80% of chromate workers  are  ever-smokers (individuals who smoke at least 100






                                      7-91

-------
   cigarettes during their lifetimes)  and only 50%  of the general white male

   population are ever-smokers.   It could also result from other assumptions about

   the smoking habits of the chrornate  workers  and the general  population.   For

   instance,  the background rate could be increased by approximately 40%,  based on

   the age-specific cancer rates provided by Doll (1971),  if  the proportion of

   smokers in each smoking level is distributed as  follows:


                         NUMBER OF  CIGARETTES  SMOKED PER DAY
0
Chromate workers 0 .3
General population 0.5
1-14
0.2
0.2
15-24
0.3
0.2
25 or more
0.2
0.1
   Other  reasonable  assumptions  about the smoking habits of the cohort workers would

   not  reduce  the  risk estimate  by more than 50%.  Therefore, it  is unlikely the
<*"N
 f  risk is  overestimated by more than four times, considering both the smoking

(^habits and  the  underestimates of exposure by a factor of two.


       7.2.3.2.   POTENCY ESTIMATION BASED ON LANGARD ET AL. (1980) — The

   study  population  consisted of 976 employees of a ferrochromium plant in Norway

   who  worked  for  at  least one year, were alive after 1953, and were initially

   employed prior  to  1953.  All  members of the study population were considered

   "under observation" from the  beginning of 1953 until 1977 inclusively, or in the

   case bf later initial employment, from one year after employment in the plant.

   A subgroup  of 325  workers were identified as specifically associated with

   ferrochromium production and  considered exposed to chromium.   The relative risk

   of lung cancer  in  chromium-exposed workers was estimated to be 8.5 when non-

   chromium-exposed workers in the same plant were used as a control population.


                                        7-92

-------
The authors considered the use of this control group more appropriate than the




other reference populations because both chromium-exposed and non-chromium-




exposed workers were similar with respect to the factors that could influence




lung cancer response.  The chromium concentration to which the workers were




exposed is not available.  In a complete industrial hygiene survey carried out




during 1975, the ambient chromium levels in the plant were found to be between




0.01 mg/m3 and 1.34 mg/m3, and of this chromium, it was determined that 11% to




33% was hexavalent.  Clearly, the measurements taken in 1975 underestimate the




actual chromium ambient levels to which most of the workers were exposed.




These concentrations are used in our potency calculations, with the understanding




that the potency so estimated can only be considered an upper-bound estimate.




     Assuming that the hexavalent chromium content in the sample was 19% (i.e.,




the geometric mean of 11% and 33%), the hexavalent chromium ambient concentrations




ranged from 1.9 ug/m3 to 254.6 ug/m3.  These concentrations are "standardized"




to the lifetime exposure, 0.1 ug/m3 and 14.0 ug/m3, as calculated by the formula






                         d x (8/24) x (240/365) x (£/L)






where d is the ambient level (either 1.9 or 254.6 ug/m3); values (8/24) and




(240/365) reflect that a worker worked 8 hours per day, 240 days for a year;  and




the factor (fc/L) represents the ratio of time in years an "average" worker was




exposed and the average age of the cohort when the study terminated.  In the




absence of detailed information,  the ratio (£/L) is assumed to be 1/4, as




usually estimated in other cohort studies.




     The carcinogenic potency of  hexavalent chromium (Cr VI) is calculated to




range from






                  B = (8.5-1) x 0.036/14.0 - 1.9 x 10~2/ug/m3
                                      7-93

-------
to




                      B = (8.5-1) x 0.036/0.1  = 2.7/ug/m3.









The geometric mean of these two limits is 0.23/ug/m-^.   It is noted that even the




lower range of the estimate (1.9 x 10~^/ug/m^) is greater than the potency estimate




calculated from the Mancuso (1975) data (1.2 x 10""2/ug/m3).






     7.2.3.3.  POTENCY ESTIMATION BASED ON AXELSSON ET AL. (1980) — The study




cohort consisted of 1,876 men who were employed for one or more years between




1930 and 1975 and who were alive as of 1951.  The chromium-exposed population was




compared with males in the county in which the plant was located.  The workers




were classified into four groups consisting of (1) arc-furnace workers; (2) workers




in transport, metal grinding, and sampling; (3) maintenance  workers; and (4)




office workers.  The study did not show a significant  increase of respiratory




cancer in the exposed population, except in the case of the  maintenance workers.




Four respiratory cancers were observed in the group of 315 maintenance workers




versus one expected.  Of the four cases of respiratory cancer, two were diagnosed




as mesotheliomas which the authors suggested may have resulted from exposure to




asbestos.  Excluding the two cases of mesotheliomas, the relative risk for lung




cancer is 2, which is not statistically significant.  To utilize the data from a




negative study, the 95% upper limit of the relative risk, 3.7, is used to




calculate an upper-bound estimate of potency.




     The ambient levels of hexavalent chromium to which the  maintenance workers




were exposed was estimated to be 50 ug/m-*.  The authors cautioned against the




use of this exposure estimate.  However, the authors did not indicate how the




estimate was obtained and did not provide hints as to whether this estimate is




likely to be higher or lower than the true ambient levels.
                                      7-94

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     Using the relative risk of 3.7 and the ambient level of 50 ug/m3, the




carcinogenic potency of hexavalent chromium is estimated to be







                  B = (3.7 - 1) x 0.036/2.7 - 3.5 x 10~2/ug/m3







where the lifetime dose 2.7 ug/m3 is calculated by







                  50 x (8/24) x (240/365) x (1/4) = 2.7 ug/m3.









     7.2.3.4.  POTENCY ESTIMATION BASED ON POKROVSKAYA ET AL. (1973) —




Although this study showed a significant increase of lung cancer mortality over




the control group, the validity of the data is questionable because the study




cohort is not clearly defined.  The report indicates that the cancer mortalities




over the period 1955-1969 in workers from a ferroalloy plant in the Soviet Union




were compared with the population of similar ages in the city where the plant




was located, but it fails to indicate the criteria by which workers were




included in the cohort.  The lung cancer mortality ratios were reported to be




4.4 for the age group 30-39 and 6.6 for the age group 50-59 among male workers.




Concentrations of hexavalent chromium wf>re reported to exceed the marginally




allowable value (0.01 mg/m3) by 2 to 7 times on the average.  The length of




employment was from 7 to 20 years, with an average of 15 years.




     Based on the information that the average ambient concentrations of hexava-




lent chromium exceeded the marginally allowable value 0.01 mg/m3 by 2 to 7




times, workers' exposure to hexavalent chromium ranged from 0.02 mg/m3 to 0.07




mg/m3.  The lifetime doses corresponding to 0.02 mg/m3 and 0.07 mg/m3 are,




respectively, as follows:







           dl = 0.02 x 103 x (8/24) x (240/365) x (1/4) =1.1 ug/m3
                                      7-95

-------
and




           d2 = 0.07 x 103 x (8/24) x (240/365) x (1/4) = 3.8 ug/m3






If 6.6 is taken to be an estimate of the average relative risk for the cohort,




then the carcinogenic potency for hexavalent chromium (Cr VI) is calculated to




range from






                   B = (6.6-1) x 0.036/3.8 = 5.2 x 10~2/ug/m3




to




                      B = (6.6-1) x 0.036/1.1 = 0.18/ug/m3






The geometric mean of the two limits is 9.7 x 10~^/ug/m3.  It is about 8 times




larger than 1.2 x 10~^/ug/m3, the potency calculated on the basis of the Mancuso




(1975) data.






     7.2.3.5.  COMPARISON OF UNIT RISK ESTIMATES ON THE BASIS OF DIFFERENT HUMAN




STUDIES — The carcinogenic potency, B, calculated on the basis of data from the




three foreign studies cited above, can be used to calculate unit risks by means




of the formula P(d) = l-exp(-B x d) with d = 1 ug/m^.  When B x d is small,




P(d) can be approximated by B x d.  The results of these calculations, along




with the unit risk estimate of Mancuso (1975), are presented in Table 7-20.




Lower, best, and upper limits are provided.  These limits reflect various




uncertainties associated with the calculation of potency estimates.  For the




Mancuso study, the lower limit represents the uncertainties associated with




possible underestimation of the chromium exposure levels and the smoking habits




of the cohort workers.  It is assumed that the risk calculated without correcting




these factors is overestimated by four times.  The upper limit for the Mancuso




study is calculated by assuming that the ratio of trivalent chromium (Cr III)  and




hexavalent chromium (Cr VI) is 6, and thus the risk is underestimated by seven






                                      7-96

-------
times.  For Langard et al. (1980) and Pokrovskaya et al. (1980), the "best"

estimate is the geometric mean of the lower and upper limits, which correspond,

respectively, to the maximum and minimum hexavalent chromium ambient levels

reported.  For Axelsson et al., the statistical upper limit (95% confidence

limit) is used as the best and upper-limit estimate because the study was negative.
          TABLE 7-20.  COMPARISON OF UNIT RISKS (LIFETIME RISK DUE TO
                     1 ug/m3 OF HEXAVALENT CHROMIUM IN AIR)
Data base
Mancuso (1975)
Langard et al. (1980)
Axelsson et al.
(1980)
Pokrovskaya et al.
(1973)
Lower limit
3.0
1.9
Not

5.2

x 10"3
x 10-2
available

x 10-2

Best
1.2
1.3
3.5

9.2

estimate
x 10-2
x 10-1
x 10~2

x 10-2

Upper
8.4 x
9.3 x
3.5 x

1.6 x

limit
10-2
10-1
10-2

io~i

     7.2.3.6.  RELATIVE CARCINOGENIC POTENCY OF CHROMIUM ~  Figure 7.1 is a

histogram representing the frequency distribution of the potency indices of 53

suspect carcinogens evaluated by the CAG.  Table 7-21 presents the potency

index for these 53 suspect carcinogens.  The potency index for a compound is a

rounded-off number expressed in terms of (mMol/kg/day)"l.  Where human data are

available for an agent, they have been used to calculate the index.  Where no

human"data are available, animal oral studies have been used in preference to

animal.inhalation studies.

     Based on the occupational study by Mancuso (1975) and the assumption that

the daily air intake of a 70-kg man is 20 m3, the potency index for chromium is

calculated as 4 x 10+3, which lies in the first quartile of the distribution.


                                      7-97

-------
0-
       -1
                                    4th       3rd       2nd       1st
                                 QUARTILE  QUARTILE  QUARTILE   QUARTILE
                                            + 1         +2       -t-3
                                        1 x 10     4 x 10     2 x 10
  2345
LOG OF POTENCY INDEX
7     8
Figure 7-1.   Histogram representing the frequency distribution of the
             potency  indices of 53 suspect carcinogens evaluated by  the
             Carcinogen Assessment Group.
                                     7-98

-------
TABLE 7-21.   RELATIVE CARCINOGENIC POTENCIES AMONG 53 CHEMICALS EVALUATED BY
      THE CARCINOGEN ASSESSMENT GROUP AS SUSPECT HUMAN CARCINOGENS1.2.3
Slope
Compounds (mg/kg/day)"1
Acrylonitrile
Aflatoxin Bi
Aldrin
Allyl chloride
Arsenic
B[a]P
Benzene
Benzidene
Beryllium
Cadmium
Carbon tetrachloride
Chlordane
Chlorinated ethanes
1 , 2-dichloroethane
hexachloroethane
1,1,2, 2-tetrachloroethane
1 , 1 ,2-trichloroe thane
Chloroform
Chromium
DDT
Dichlorobenzidine
1 , 1-dichloroethylene
Dieldrin
0.24(W)
2924
11.4
1.19x10-2
15(H)
11.5
5.2xlO-2(W)
234(W)
1.40(W)
7.8(W)
1.30X10-1
1.61
6.9xlO-2
1.42x10-2
0.20
5.73x10-2
7x10-2
41(W)
8.42
1.69
1.47x10-1(1)
30.4
Molecular
weight
53.1
312.3
369.4
76.5
149.8
252.3
78
184.2
9
112.4
153.8
409.8
98.9
236.7
ib/.y
133.4
119.4
100
354.5
253.1
97
380.9
Potency
index
1x1 0+1
9x1 0+5
4x1 0+3
9x10-1
2x1 0+3
3xlO+3
4x10°
4x1 0+4
1x10+1
9x10+2
2x10+1
7x10+2
7x10°
3x10°
3x10+1
8x10°
8x100
4xlO+3
3xlO+3
4x10+2
1x10+!
lxlO+4
Order of
magnitude
dogl"
index)
+1
+6
+4
0
+3
+3
+1
+5
+1
+3
+1
+3
+1
0
+1
+1
+1
+4
+3
+3
+1
+4
                                                 (continued on the following page)
                                     7-99

-------
TABLE 7-21.  (continued)
Compounds
2,4-Dinitrotoluene
Diphenylhydrazine
Epichlorohydrin
Bis(2-chloroethyl)ether
Bis (chloromethyl)ether
Ethylene dibromide (EDB)
Ethylene oxide
Heptachlor
Hexachlorobenzene
Hexachlorobutadiene
Hexachlorocyclohexane
technical grade
alpha isomer
beta isomer
gamma isomer
Hexachlorodibenzodioxin
Methylene chloride
Nickel
Nitrosamines
Dimethylnitrosamine
Diethylnitrosamine
Dibutylnitrosamine
N-nitrosopyrrolidine
N-nitroso-N-ethylurea
N-nitroso-N-methylurea
N-nitroso-diphenylamine
Slope Molecular
(mg/kg/day)_i weight
0.31
0.77
9.9xlO-3
1.14
9300(1)
8.51
1.26(1)
3.37
1.67
7.75xlO-2
4.75
11.12
1.84
1.33
6.2xlO+3
6.3xlO~4
1.15(W)
25.9(not by q*)
43.5(not by q*)
5.43
2.13
32.9
302.6
4.92x10-3
182
180
92.5
143
115
187.9
44.1
373.3
284.4
261
290.9
290.9
290.9
290.9
391
84.9
58.7
74.1
102.1
158.2
100.2
117.1
103.1
198
Potency
index
6x1 0+1
lxlO+2
9X10"1
2x1 0+2
1x1 0+6
2x10+3
6xlO+1
1x10+3
5x1 0+2
2x1 0+1
1x10+3
3x10+3
5x1 0+2
4x10+2
2x1 0+6
5xlO"2
7xlO+1
2x10+3
4x10+3
9xlO+2
2xlO+2
4x10+3
3xlO+4
1x10°
Order of
magnitude
(logic
index)
+2
+2
0
+2
+6
+3
+2
+3
+3
+1
+3
+3
+3
+3
+6
-1
+2
+3
+4
+3
+2
+4
+4
0
                     (continued on the following page)
         7-100

-------
                            TABLE 7-21.   (continued)
Order of
Slope
Compounds (mg/kg/day)_i
PCBs
Phenols
2 , 4 , 6-t richlorophenol
Tetrachlorodibenzo-p-dioxin
Tetrachloroethylene
Toxaphene
Trichloroethylene
Vinyl chloride
4.34
1.9 9x1 0~2
1.5 6x1 0+5
3.5x10-2
1.13
1.9xlO-2
1.75x10-2(1)
Molecular
weight
324
197.4
322
165.8
414
131.4
62.5
magnitude
Potency (logjo
index index)
1x1 0+3
4x10°
5x1 0+7
6x10°
5x10+2
2.5x10°
1x10°
+3
+1
+8
+1
+3
0
0
Remarks:

1.  Animal slopes are 95% upper-limit slopes based on the linearized multistage
    model.  They are calculated based on animal oral studies, except for those
    indicated by I (animal inhalation),  W (human occupational exposure), and H
    (human drinking water exposure).  Human slopes are point estimates based on
    the linear non-threshold model.

2.  The potency index is a rounded-off slope in (mMol/kg/day)"^ and is calculated
    by multiplying the slopes in (mg/kg/day)"1 by the molecular weight of the
    compound.

3.  Not all of the carcinogenic potencies presented in this table represent the
    same degree of certainty.  All are subject to change as new evidence becomes
    available.
                                     7-101

-------
This provides an estimate of the relative potency of chromium in comparison




with other suspect carcinogens evaluated by the GAG.






7.2.4.  Summary.  Epidemiologic studies of chromate production facilities in




the United States, Great Britain, West Germany, and Japan have all found an




association between occupational exposure to chromium and lung cancer.  Workers




in the chromate production industry are exposed to both trivalent chromium (Cr




III) and hexavalent chromium (Cr VI) compounds.  Most of the epidemiologic




studies did not attempt to determine which chromium compounds were the etiologic




agents.




     The strength of the association of exposure in the chromate production




industry with lung cancer is evident by the high lung cancer mortality ratios




found in various studies, the consistency of results by different investigators




in different countries, the dose-response found in several studies, and the




specificity of the tumor site (i.e., the lung).  The respiratory cancer mortality




ratio for chromate production workers was louud to be as high as 29 by Brinton




et al. (1952) and as low as 2.0 by Korallus et al. (1982).  Comparison of




mortality ratios across studies would not be valid because of differences in




exposure intensity and duration, length of observation period, and percentages




of the cohort lost to follow-up.  Certainly, however, the magnitude of the




mortality ratios found in several studies (studies of three independent cohorts




of chromate production workers found lung cancer mortality ratios of at least




9.5 or greater) lends strong support to the association of exposure in the




chromate production industry with lung cancer.




      Three studies of the chrome pigment industry, one in Norway, one in Great




Britain, and the third in the Netherlands and  Germany, have also found an




association  between occupational exposure to chromium and lung cancer.  The




predominant  chromium exposure in the chrome pigment industry  is  to hexavalent




                                     7-102

-------
chromium (Cr VI).  One study of the chromium plating industry in England




(Royle 1975) reported that workers exposed primarily to hexavalent chromium




(chromic acid mist and some dichromate dust) had significantly (P < 0.05)




higher mortality from cancer at all sites than the control group; respiratory




cancer mortality was not found to be elevated, however, and the follow-up




period was only for 3 years.  Thus, the results are inconclusive.  The results




of a Japanese study of chrome platers (Okubo and Tsuchiya 1979) were negative.




A proportionate mortality study by Silverstein et al. (1981) of a die-casting




and electroplating plant where chromium was used for electroplating found an




excess of lung cancer mortality, but because of the presence of other carcinogens




in the plant, no conclusions regarding the association of chromium and lung




cancer can be drawn from this particular study.  The results of studies of the




ferrochromium industry are inconclusive as to lung cancer risk.




     In most of the studies, smoking data were inadequate for any detailed




analyses of smoking as a confounding variable with respect to lung cancer.




However, the relative risks of lung cancer found by several of the studies of




chromate production workers were higher than the risks that would be expected




on the basis of differences in smoking habits between the study group and the




controls.  Also, the dose-response in terms of length of time worked in the




industry seen in the Hayes et al. (1979) and the Taylor (1966) studies, and the




dose-response found by Mancuso (1975), in terms of mg/m^-years of total chromium,




are not likely to be explained by differences in smoking habits among the dose




groups.




     Using the International Agency for Research on Cancer (IARC) classification




scheme for the assessment of human evidence of carcinogenicity, the CAG considers




that the epidemiologic evidence of the carcinogenicity of chromium is sufficient




to establish a causal relationship between chromium and cancer in humans.






                                     7-103

-------
     Chromium compounds have not induced significantly increased incidences of




tumors in laboratory animals following exposure by the inhalation and ingestion




routes.  Neither trivalent (Cr III) nor hexavalent (Cr VI) chromium compounds




have induced significantly increased incidences of lung tumors by inhalation.




Similar results have been obtained following the ingestion of trivalent chromium




compounds; however, these studies have not been reported in detail.  There is




some positive evidence that hexavalent chromium compounds are carcinogenic




following subcutaneous injection or intrabronchial, intrapleural, intramuscular,




or intratracheal implantation; however, implantation site tumors have only




consistently been demonstrated using intramuscular implantation.  Of all the




chromium salts, calcium chromate is the only one that has been consistently




shown to be carcinogenic in rats by several routes.  Other chromium compounds,




strontium chromate, zinc chromate, sodium dichromate, lead chromate, lead




chromate oxide, and sintered chromium trioxide, have produced local sarcomas or




lung tumors in rats at the site of application.  Although the studies available




indicate that metallic chromium powder and trivalent chromium compounds are




not carcinogenic, these compounds have been studied less extensively than




hexavalent chromium compounds.  The relevance of studies using intramuscular




implantation to human risk following inhalation or oral exposure to chromium




compounds is not clear; however, these animal studies suggest that some hexa-




valent chromium compounds are likely to be the etiologic agent in human




chromium-related cancer.




    ' Although a number of epidemiologic studies have found an association between




exposure to chromium compounds and lung cancer, the best data that can be used




for estimating cancer risks due to exposure to chromium compounds are found in




the study by Mancuso (1975).  Mancuso (1975) reported age-specific lung cancer




mortality data for chromate production workers in terms of total chromium






                                     7-104

-------
exposure, which included exposure to both trivalent (Cr III) and hexavalent




(Cr VI) chromium compounds.  As noted previously, available data suggest that




only hexavalent chromium compounds are carcinogenic.




     Thus, a cancer risk estimate based on total chromium expooure will under-




estimate the risk due to hexavalent chromium alone.  In the Bourne and Yee




(1950) study, the ratio of trivalent (Cr III) to hexavalent (Cr VI) chromium




in the airborne dust in the plant's nine major departments ranged from 1 to 3,




except in the case of two departments, where the ratios were 6 for the lime




and ash operation and as high as 52 for the ore preparation operation.  There-




fore, the ratio of trivalent and hexavalent chromium in the plant did not




exceed 52, seems unlikely to exceed 6, and may be smaller.  Thus, the under-




estimation of the risk from hexavalent chromium when the Mancuso (1975) data




on exposures to total chromium are used is unlikely to be more than sevenfold,




if the ratio is assumed to be 6.  There are two other factors, however, that




may result in an overestimation of the risk:  (1) there is a possibility that




the use of 1949 hygiene data may result in some degree of underestimation of




worker's exposures, and (2) the risk presented in this report may be somewhat




overestimated because of the implicit assumption that the smoking habits of




chromate workers were similar to those of the general white male population.




It is difficult to determine how much the risk has been overestimated in this




regard.  However, it seems reasonable to assume that the risk is not over-




estimated by more than 4 times on the assumption that 80% of the chromium




workets and 50% of the control population smoked cigarettes, and that the




exposure may be underestimated by a factor of 2.




     Thus, these factors must be considered when interpreting the CAG's approx-




imation, calculated from the Mancuso (1975) data, of the lifetime cancer risk




due to a constant exposure to air containing 1 ug/m-* of hexavalent chromium






                                     7-105

-------
(Cr VI).  The unit risk, is calculated as 1.2 x 1CT2 on the basis of total




chromium in the chromate plant.  As discussed previously, this figure could




either underestimate or overestimate the risk of hexavalent chromium.  The use




of total chromium as a surrogate for hexavalent chromium could result in an




underestimate of the risk from hexavalent chromium by no more than 7 times; on




the other hand, underestimation of plant exposures and of smoking habits in




the workers could lead to an overestimate of the risk by roughly 4 times.  On




balance, the estimate based on the Mancuso data is judged to be the best possible




estimate of the risk from hexavalent chromium.




     Data from three studies on ferrochroraium plants in Norway, Sweden, and the




Soviet Union have also been used to calculate the carcinogenic potency of hexa-




valent chromium (Cr VI).  Each of these studies has at least one characteristic




(e.g., underestimation of ambient chromium concentration, concurrent exposure




to asbestos, and ill-defined cohort) that makes it less adequate than the




Mancuso study for purposes of risk assessment.  Most of these characteristics




tend to overestimate the risk.  The deficiences of these foreign studies are




addressed in detail in the epidemiology section.  As may be expected, the




carcinogenic potency (and hence, the unit risk) estimated from the Mancuso




data is consistently smaller (but within a factor of 5) than the lower-limit




potency estimates calculated from the three foreign studies.






7.2.5.  Conclusions.  The following conclusions can be made:




1.  Using the IARC criteria, the epidemiologic studies of chromate production




    workers would be classified as sufficient evidence of carcinogenicity.




2.  Using the IARC criteria, the evidence of the carcinogenicity of hexavalent




    chromium (Cr VI) in animal bioassay studies would be considered sufficient.




    The results in animals appear to be determined to some extent by the




    solubility of hexavalent chromium compounds.  Trivalent chromium (Cr III)




                                     7-106

-------
    has not yet been found to be carcinogenic in animal studies.




3.  Accepting the findings as reported elsewhere in this document, hexavalent




    chromium (Cr VI) is mutagenic.   The GAG considers this to be supportive




    of the finding that hexavalent  chromium is carcinogenic in animal bioassays.






     The lifetime cancer risk due to air containing 1 ug/nH of hexavalent




chromium compounds is estimated to  be 1.2 x 10~^.  This would place hexavalent




chromium (Cr VI) in the first quartile of the 53 compounds evaluated by the




CAG for relative carcinogenic potency.




     Using the IARC classification  scheme, the level of evidence available for




the combined animal and human daLa  would place hexavalent chromium (Cr VI)




compounds into Group 1, meaning that there is decisive evidence for the




carcinogenicity of those compounds  in humans.
                                     7-107

-------
7.3. GENOTOXICITY








7.3.1.   In  Vitro  Mutagenicity.  In  an attempt to  understand  the fundamental



biological activity of metals  and  its relationship to carcinogenesis, numerous



in  vitro experiments have  been conducted.   Many  of these  studies  attempt to



exploit  the  strong   relationships  between  molecular   events   involved  in



mutagenesis  and  carcinogenesis.  In particular,  the interaction of xenobiotics



with nucleic acids is believed  to be a critical event in mutagenesis and/or cell



transformation.  Cultures of mammalian cells and bacteria, as well as cell-free



systems, have been used to explore the potential mutagenicity/carcinogenicity of



chromium salts.  Although mutagenicity assays  employing bacterial tester strains



have received widespread  use in screening compounds for mutagenicity (e.g., Ames



assay),  these  assay systems have  not  been  frequently employed  for  screening



metals.  Nevertheless, positive results have been obtained  with several metals in



both in vitro mutagenicity assays and assays using DNA repair deficient bacteria.




A summary of the results obtained from in vitro mutagenicity assays of chromium



compounds are presented in Table 7-22.



     In an early study of the  mutagenicity of chromium in bacteria,  Venitt and



Levy (197*0 tested three soluble Cr(VI)  salts (Na-CrO., K-CrOj.,  and CaCrOJ for



mutagenic activity using a  spot test.  Following application of each compound to



the plate at levels of 0.05, 0.10,  or 0.20 pmol, a  3-fold increase was observed



in the number of reversion  colonies in  the tester  organism E.  coli WP2 (try").



Similar results were observed  with  both E. coli WP2 and  WP2 uvrA  (absence of



excision-repair) were exposed  to Na CrO^ in suspension,  followed  by  removal of



the test compound and plating on minimal plates.   Repair  deficient E.  coli WP2



(exrA,  error prone DNA repair)  and WP2 uvrA were compared  with wild type E. coli




WP2 for  mutagenic response  in the spot  test  to  K CrO^.   Since  all  tester
                                     7-108

-------
                      TABLE 7-22




The In Vitro Mutagenicity Bioassay  of Chromic Compounds

Test
Reverse mutation E.
Reverse mutation E.
E.
Reverse mutation E.
E.
E.
Reverse mutation E.
E.
^ E.
1
1 — i
o Reverse mutation E.
Reverse mutation E.
Reverse mutation E.
E.
Reverse mutation S.
Indicator
Organism
coli WP2 (try")
coli HP2 (try")
coli HP2 uvrA
coli WP2 (try")
coli WP2 uvrA
coli WP2 exrA
coli WP2
coli WP2 uvrA
coli CM571
coli Hs30R
coli WP2
coli WP2
coli B/r WP2
typhimurium
TA92
Reverse mutation S. typhiraurium
TA1978, TA92
Compound
Tested
K_CrOa
cicroz
Na^K^
K CrO,
K2Cr°l)
K Cr 0
K2Cr2°7
K2Cr2S"
K2Cr2°7
chromate*
di chromate*
chromate*
di chromate*
chromate*
dichromate*
Valence
State
+6
+6
+6
+6
+6
+6
+6
+6
+6
+6
+6
+6
+6
+6
+6
+6
-1-6
+6
+6
+6
+6
Metabolic
Activation
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
yes
yes
Dose
0.05, 0.10, and
0.20 pmol/plate
0.5 to 5 rag/ml
0.5 to 5 rag/mil
0.05 pmol/plate
0.05 pmol/plate
0.05 pmol/plate
1.0 x 10"^M
1.2 x 10"^M
1.2 x 10"^
13.0 x 10"^M
13.0 x 10'^M
0.5 pg/mfc
NR
NR
NR
NR
100 and 200
nraol/plate
100 and 200
nmol/plate
100 and 200
nmol/plate
100 and 200
nmol/plate
Application Response
spot test +
suspension assay +
suspension assay +
spot test •»•
spot test +
spot test +
suspension assay +
suspension assay +
suspension assay
suspension assay +*
suspension assay +*
fluctuation test +
spot test +
spot test
plate +
incorporation
plate +
incorporation
plate +
incorporation
plate +
incorporation
plate
incorporation
plate
incorporation
Reference
Venitt and
Levy, 1971
Venitt and
Levy, 1971
Venitt and
Levy, 1971
Nishioka, 1975
Nakamuro et al . ,
1978
Green et al . ,
1976
Kanematsu
et al., 1980
Lofroth and
Ames, 1978
Lofroth, 1978

-------
TABLE 7-22 (oont.)
Test
Reverse mutation



Reverse mutation



Reverse mutation



















Forward mutation

Forward mutation
to 8-azaguanine
resistance
Indicator
Organism
S. typhimurium
TA1535, TA1537,
TA1538, TA100,
TA98
S. typhimurium



S. typhimurium
TA1535, TA1537
TA98, TA100

















Schizosaccharomyces
pombe
Chinese Hamster
V79 cells

Compound
Tested
K Cr 0
c t (


Na Cr,07
t C. \
Na Cr_07
£• C. 1
Na Cr 0
t C f
CrO,
J
CaCrOj.

K,Cr,07
^ £ i
ZnCrOu*Zn(OH)_

Na Cr 0?
C, C. \
CrO

CaCrO,,

KCr 0
*• ^ I
ZnCr01(«Zn(OH)2

K2Cr2°7

^Cr6°7

PbCro!!
Valence
State
+6



+6

+6

+6

+6

+6

+6

+6

+6

+6

+6

+6

+6

+6

+6
+6
+6
Metabolic
Activation
no



no

yes

no

no

no

no

no

yes

yes

yes

yes

yes

no

no
no
no
Dose
NR



10 to 40 pg/plate

10 to 80 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

10 to 200 pg/plate

102pM

0.35 to 0.78 pg/m«.
1 to 4 pg/mH
5 to 10 pg/mi
Application Response
spot test



plate •»•
incorporation
plate
incorporation
plate +
incorporation
plate •»•
Incorporation
plate +
incorporation
plate +
incorporation
plate +
incorporation
plate
incorporation
plate
incorporation
plate
incorporation
plate
incorporation
plate
incorporation
suspension +'

in culture medium +
in culture medium +
in culture medium
Reference
Kanematsu
et al., 1980


DeFlora, 1978;
Petrilli and
DeFlora, 1978

Pe trelli and
DeFlora, 1977,
1978

















Bonatti et al. ,
1976
Newbold et al.,
1979


-------
                                                                   TABLE 7-22 (cont.)
Test
Gene conversion
Gene conversion
Reverse mutation
-a
i
_. Reverse mutation
— *
Reverse mutation
Reverse mutation

Indicator
Organism
Schizosacoharomyces
pombe
Saccharemyces
cerevisiae D7
E. coli (try") Cr
E. coli H.-30R

S. typhimurium
TA98, TA1537,
TA1535, TA100
S. typhimurium
TA100

Compound
Tested
K2Cr20?
Cr03
_(S01.).1K,SO,-2l»H,0
Cr(CH,COO),
3 3
CrK(SO^)2«12H20
CrCl3'6H20
CrK( SO,^ -12H20
Cr(N03)3.9H20
Valence
State
+6
+6
+3
+3

+3
+3
+3
+3
+3
Metabolic
Activation Dose
no 102 to 105pM
no 10~2 to 10"3
no NR
no 130 x 10"3M

no/yes 20 mg/plate
no /yes
no/yes 800 pg/plate
no
no
Application Response
suspension +
suspension +
spot test*
suspension assay +•

plate
incorporation
plate
incorporation
plate
Incorporation
-
Reference
Bonatti et al. ,
1976
Fukunaga et al. ,
1982
Venitt and
Levy, 197t
Nakamuro et al. ,
1978
Petrilli and
DeFlora, 1977
Petrilli and
DeFlora, 1978a,b

* = Refer to text for further information.



NR = Not reported

-------
organisms yielded approximately  the same mutagenic response  regardless of the



presence or absence of DNA repair pathways, the authors concluded that  chromium



directly  interacted  with DNA,  with subsequent  mispairing of  bases occurring



during cell division.   Other possible explanations for  these results  were not



considered.   The  soluble  Cr(III)  compound,  Cr2S0ltK2SO]|»2H20  [This  was  the



formula  given  in  the   report,  although  the  test  compound  was   probably



Cr;?(S01.),"K2S01.«21lH20.] ,  gave  negative  results  (specifics  in  experimental



protocol were not given),  along with soluble salts of tungsten, molybdenum, zinc,



cadmium, and mercury.



     Nishioka (1975) obtained positive mutagenic results with K Cr20_(VI) in a



suspension assay using  the tester strain E. coli WP2 and WP2 uvrA, but not  in the



tester strain E.  coli  CM,.-..  Since strain  CM..™, is a recombination-deficient
                                               DM
strain, it was  postulated  that metal mutagenesis needed  some component of the



recA allele.  Positive results were also reported for K2Cr20? by Kanematsu et al.



(1980) in the spot test using  strain E. coli  WP2;  however,  E. coli B/r WP2 was



negative  (no  dose information was  presented  in this  study).  Nakamuro et al.



(1978) used E. coli HsSOR, a uvrA minus mutant requiring arginine, to study the



mutagenicity of KgCr^tVI) and KgCrO^VI), and  Cr(CH3COO)3(III)  in a suspension



assay.  The respective mutagenic frequency of these compounds was  13**, 45, and  30

            o

mutants x 10  viable cells.  Although positive mutagenic responses  were  reported



for all test substances, the low survival of between 4 and  10$ at  the doses which



were  reported  as  mutagenic may lead to artifacts,  particularly if spontaneous



revertants arise during growth on the trace levels of arginine used  to supplement



the top agar, as suggested by  Green  (1976).



     Green  et  al.   (1976)  also  observed  mutation  in  E.   coli  WP2  using   a



fluctuation test.  At levels of 0.5  pg/m£  KpCrOj.,  148 of 250  tubes  were  positive



as compared to 61 in controls.  At a  high dose of 2.5 pg/mJl, only 10 of  150 tubes
                                      7-112

-------
were positive as  compared  with 34 tubes  in  the controls.   The  apparent anti-




mutagenic effect at the higher dose was attributed to the toxicity of the K CrOj..



     The mutagenicity of chromium compounds has been assessed in the Ames assay,




which  uses  specially  constructed  histidine  dependent  strains  of Salmonella




typhimurium; however, in the original report  on  the  validation  of this assay,




McCann  et  al.   (1975) stated  that the test  was not suitable for metals as a




result of  the high concentration  of magnesium, citrate,  and phosphate salts in




the media.   Chromate  and dichromate but not the chromic ion  (the  specific salt




was not mentioned) were reported in an abstract to cause frameshift mutations in




S. typhimurium strains containing the his D3052 and his C3076 mutations,  as well




as his G 46 strains containing the R  factor.   The greatest response was observed




in  TA92 with five revertants/nmol Cr.   Kanematsu et al.  (1980)  has reported




negative results with K-Cr  0_ in the spot test using strains  TA1535, TA100, TA98,




TA1537, and  TA1538; however,  the  lack of exposure  information  in this report




makes it difficult  to evaluate.  In a  recent  study of the mutagenic activity of




chromic chromate  (18.5$ Cr(VI), and 50% total chromium) in S.  typhimurium strain




TA1535, Witmer  et al.  (1982)  reported that  mutagenic  activity,  expressed  as




number  of  revertants  on  test  plates T  number  of  revertants  on spontaneous




plates, was increased as the  standard salt concentration of the minimal media was




reduced.   At least a  portion of this observed increased activity  resulted from




the poor survival of the cells in  the  low  salt  media and the  associated decrease




in  the number  of  spontaneous  colonies.    Although  the author  suggested that




variation  in the S. typhimurium assay may  be  useful in further evaluation of the




mutagenic  activity of  inorganic compounds such as chromium, further validation




of this method  will be  required before these  results can be compared with the




other available data on mutagenicity of chromium.
                                     7-113

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     In further studies, Lofroth (1978) found that chromate and dichromate were
mutagenic  in  strain  TA1978  as  well  as   TA92.    On addition  of  a mammalian
microsomal  activation system  (S-9  mix)  prepared  from  the  livers  of Aroclor
pretreated male rats,  the number of revertants decreased  from 206 and  357 (assays
without activation  system) to  89  and  89 (assays  with  activation  system)  for
TA1978 and  TA92,  respectively.  In  the  absence of NADP  in  the S-9  mix,  the
inhibition of  chromium  mutagenicity  did not occur.   It was  also reported that
addition of  Cr(VI)  to an aqueous solution of  NADP did  not change  the valence
state of chromium.  It was  concluded that  NADP plus  additional  factors in the S-9
mix  were  necessary to  inactivate Cr(VI),  possibly  by reduction  to  Cr(III).
Similarly,  Petrilli  and  DeFlora  (1977)  obtained  positive  responses  with
Na2Cr2°7'  Cr°3» CaCr°n» and K2Cr2°4 wnen assayed in  strains TA1537, TA1535, TA98,
and TA100  at levels  between 10 and 200 pg/plate.  When the response was expressed
as revertants/pg of  Cr(VI),  there was no statistically significant difference in
the activity of each  of these  compounds.   The  Cr(III) compounds,  CrK(SO.)_  and
CrCl,, gave negative results.
     DeFlora  (1978)  and  Petrilli  and  DeFlora  (1978a,b)  further  studied  the
effect of metabolic  activation on the mutagenicity of Cr(VI) and (III).   DeFlora
(1978) observed a decrease in the mutagenicity of Na Cr 0  in  S.  typhimurium
strain TA100 in the  presence of S-9  mix prepared from rat liver.   When  NapCr 0
was added  at 40 pg/plate,  the  number of revertant colonies decreased from 705 to
420, 370,  283, 228,  and  221 with the  incorporation, respectively,  of 0, 10,  20,
30, 40, and  50 pI of  S-9 fraction/plate.   Petrilli  and DeFlora  (1978b)  extend
these  observations   to   the  Cr(VI)   compounds    Na  Ca  0_,   CrO-,,   KpCrCL,
ZnCrOjj'Zn(OH)2 (zinc yellow also contained 10$ CrO,), and PbCrOj*PbO, with muta-
genic activity in  strains TA1535, TA1537, TA98, and TA100 detected in the absence
of S-9 mix but  not in the presence of S-9 mix, prepared from rat  liver.  Little or
                                      7-114

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no loss of mutagenic activity occurred when the added  S-9 was prepared  from  lung



or muscle.   Also,  human plasma added to the top agar had no effect on chromium



mutagenicity, but  lysates  of erythrocytes did  result in  the loss of mutagenic



activity.   The  loss of mutagenicity was associated with reduction potential of



components  in  the  S-9 mix, with  reduced  GSH,  TPNH,  and G6PD  plus  S-9 mix  (to



generate  TPNH)  all  inhibiting the mutagenicity of Cr(VI).    In  a  study using



varying levels of TPNH, the mutagenic response  was  correlated with the amount of




Na2Cr207  (originally 52 pg Cr(VI)/plate)  that  remained  as Cr(VI).  Conversely,



Cr(III) as CrKtSOj.)-, CrCl,, and CrtNO,)^ which were inactive in the Ames assay,



were  converted  to  active  mutagens by  the  addition of nontoxic  levels  of the




strong  oxidizer KMnO^  (Petrilli  and DeFlora,  1978a).    The presence of this



oxidizing agent  reversed  the effect of S-9  mix on the  mutagenicity of Cr(VI).



These data supported  the conclusions  that  the  valence state  of chromium was an



important factor in producing  a  mutagenic  response in the Ames assay, and that



naturally occurring biological reducing agents were capable  of reducing Cr(VI)



to Cr(III).  Although the studies show that Cr(VI) compounds produce a positive



response, these studies do not indicate whether Cr(III)  or (VI) is the ultimate



mutagen which interacts with the DNA of the cell.



     Further work on mutagenicity has also been reported by Warren et al. (1981),



and De Flora (1981).   Warren  et  al. tested 17 hexacoordinate Cr(III) compounds



for DNA damage with the E. coli differential repair  assay, and, for mutagenicity,



with S. typhimurium.   The  compounds showed a parallel between  mutagenicity and



differential inhibition  in the  two bioassays.   The greater  the  differential



inhibition in the repair test, the more likely the compound was mutagenic.  The



genetically most active complexes were  those that  had a charge of  +1  with two



relatively stable  ligands, along with  four  more stable  aromatic  amine ligands.




The Cr(III)  complexes were  similar in  size, reactivity and cellular transport to
                                    7-115

-------
many ambient cellular molecules.  They  concluded that the reduction of Cr(VI) in



the cell could result in a mutagenically active Cr(III) species.



     De Flora  (1981)  tested  18 chromium compounds  in  the  Salmonella microsome



test designed to provide dose response curves and a potency rating.  Ten of the



eleven Cr(VI) compounds showed  a mutagenic  response, and the dose response range



for the seven most  reactive  compounds  was  1.4 to 5.1  net revertance per nmole.



None of the  pure Cr(III) compounds  showed positive results.   Chromite,  which



contained traces of Cr(VI), was positive only for a 2 mg spot test.



     Petrilli and  De  Flora  (1982)  investigated  whether the  administration of



dichromate in rats  may modify  the lung and  S-9  fractions  by decreasing Cr(VI)



mutagenicity.   They noted that daily  intratracheal  administration  of sodium



dichromate  (0.25 mg/kg  daily,  5  times/week for  4   weeks)  increased  Cr(VI)



deactivation.  On the other hand,  S-9 fractions of muscle tissue had no effects



on deactivation.  From these  preliminary results,they concluded that sub-chronic



exposure to  Cr(VI)  could enhance the  cytoplasmic defense mechanisms  and  thus



raise the threshold of susceptibility.



     Cr(VI) compounds  have also been demonstrated to be mutagenic in vitro in



eucaryotic test  systems, while Cr(III)  was  inactive.   Bonatti et  al.  (1976)


                                                  2       5
exposed yeast,  Schizosaccharomyces   pombe,  to 10  to  10  pM  of K?Cr507  in  a



forward mutation assay and a test for gene  conversion.  Forward  mutation was


                                               2

observed in 7 of 480,05*1 colonies exposed  to 10   pM K?Cr_07 for 7  hours,  which



was not statistically increased from controls in  which no mutants were observed



in 84,546  colonies;  however,  if comparison was made to the historical spontaneous



mutation  rate  (no  mutants  in  10   colonies),   then  chromium  significantly



increased  the mutation rate.   In the study of gene conversion, there was a dose



related increase in the  four allelic combinations examined.   The authors  noted



that there  were  limitations in this study, but that the data suggest that KpCr?07



was mutagenic under the test  conditions.





                                     7-116

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     Using another strain of yeast, Saccharomyces cerivisiae D7, Fukanaga et al.



(1982) examined the genetic activity of  chromium  trioxide.   The  compound was


                                                  -2      -3
incubated with  the cells at concentrations  of 10   to 10 J M for  a  period of



24 hours.  Following incubation, the cells were plated to determine viability and



recombination in the ade locus.  The highest concentration tested caused nearly



100$ cell death while  viability at the lowest concentration was 77$.  The cross-


                                                             _p
over frequency in treated cells was dose dependent with the 10   M concentration



resulting in a frequency of 1.4$ as compared  to 0.02$  for untreated cells.  It



was also reported that only  growing and not resting cells were susceptible to the



effects  of  chromium,  suggesting  to  the  authors that  chromium may affect the



fidelity of DNA polymerase.



     Forward mutagenesis to 8-azaguanine resistance in cultured Chinese hamster



V79/4 cells was used by Newbold et al. (1979) to assess the genetic activity of



both Cr(VI) and  (III).   The highly soluble  and slightly  soluble Cr(VI) salts,



K_Cr 0_  and ZnCrO^,  respectively,  both  produced  dose   related  increases  in



8-azaguanine  resistant  cell  colonies,  while the  insoluble  Cr(VI)  compound,



PbCrOjj, and the soluble Cr(III) compound,  Cr(CH-COO)., were inactive.   The more



soluble K_Cr_07 was =5-fold more active than the  ZnCKk.   It was stressed that



both the valence state and solubility of a chromium compound affected its muta-



genic  potential.    Although  high solubility was  necessary  for   a  mutagenic



response, the authors suggested that low solubility would facilitate a carcino-



genic response,  since compounds  of lower solubility  might remain  in the body



longer, providing a low dose continuous  exposure to chromium.







7.3.2. . Effects On DNA And DNA Replication.  It is apparent from the results of



bioassays  in  both prokaryotic  and  eucaryotic  systems  that  some  chromium



compounds   are   mutagenic.     In   general,   soluble  Cr(VT)   compounds   were
                                     7-117

-------
positive in reverse and  forward  mutagenicity assays,  while insoluble salts and



Cr(III) compounds are inactive.   Metabolic  activation  inhibited the mutagenicity



of  Cr(VI),  probably  by  the  reduction  of  the  Cr(VI)  to Cr(III)  by cellular



reducing agents such  as  GSH.  Other studies have been performed which indicate



that  chromium  compounds  interact  with  DNA  and  decrease  the fidelity  of DNA



polymerase, and this mechanism may participate in chromium induced mutagenesis.



     The difference  in the sensitivity of recombination deficient  strains of



bacteria as compared to wild type to the toxic effects of  chromium compounds has



been used as an indicator of DNA damage.   Nishioka  (1975) exposed both rec~ and



rec+ strains of Bacillus subtilis to K^r^UD, KgCrO^VI), and CrCl^III) by



placing 0.05 mi of 0.05 M solution on a filter disc placed on the agar surface.



For the two Cr(VI) compounds, the zone of growth inhibition was greater for the



rec~ strains as compared  with the rec , indicating DNA  damage,  while there was no



difference in  the  size of the zone  of inhibition in the assay of  CrCl_.   The



positive rec-effect with  K^Cr^O-  was diminished sharply when the reducing agent,



Na_SO,, was mixed with the  test  compound,  indicating that the Cr(VI) oxidation



state was necessary to cause DNA  damage.  Similarly, Kanematsu et al.  (1980), in



a survey of 127 metal  compounds in the B.  subtilis rec assay, reported  that three



Cr(VI) compounds  (K CrOj., K-Cr-Oy,  and CrO.)  were  positive at 0.05 mi of a 0.005



and 0.1 M solution, respectively, for the salts and oxide.  Cr(III), Cr?(SOj.).,,



was negative,  and it was noted that the sample was toxic to the bacteria at the



dose tested.



     Nakamuro  et al.  (1978)  examined three  Cr(VI)  compounds  (K Cr 0_,  K CrO^,



and CrO-) and  three Cr(III) compounds (Cr(CH C00)_, Cr(NO-)., and CrCl,) in the



rec~ assay with B.  subtilis.   The compounds were tested using 0.02 mi aliquots of


                          -1            -2
solutions between 3.2 x  10   to  1.6 x 10    M for the Cr(VI) compound and 1.3 to



1.6 x 10~  M for  the Cr(III) compound.  All compounds tested were positive except
                                     7-118

-------
for CrClo(III).  Although DNA damage as indicated by the rec effect was observed


with   two  of  the   Cr(III)   compounds,   the   order   of  activities   was


K2Cr207 > KgCrOj, > Cr03 > Cr(CH300)3  > Cr(N03)3> with the Cr(VI) compounds being


more active than the Cr(III) compounds.


     In an attempt to determine the mechanism of DNA damage induced by chromium,


Levis et al. (1978) examined the effects  of K2Cr207 exposure on DNA synthesis in


cultured BHK cells.   The cells were  treated with  10~3,  10~\  10~5,  and 10~6 M


KpCr?07 for 1 to U hours, followed by determination of 3H-thyraidine uptake into


DNA  and  the intracellular  pools.   At  the  two intermediate  doses,  increased


specific activity was observed  in  both  the nucleotide pool  and  DMA,  which was


attributed to chromium effects on the membrane transport of  the exogenous labeled


thymidine.   When DNA synthesis  was  adjusted for the  changes  in  the specific


activity of the pools, transient and reversible inhibitions  of DNA synthesis were


observed at 10~  M, and complete irreversible inhibition occurred at 10   M.,  It


was reported that inhibition of DNA synthesis occurred prior to, and to a greater


extent than, inhibition of protein or RNA synthesis.  Although these effects on


DNA synthesis may be partly  related  to  the  effects  of chromium on the cellular


membrane, Raffetto  (1977) reported evidence of direct interaction with DNA in


AlSBcR  cultured cells,  as   indicated  by unscheduled  DNA synthesis  following


treatment with  K Cr_07 (VI).   In  cells  treated  for  1 hour with  16,  M,  or 1 pg


Cr(III)/m& (as CrCl,), no increase was produced.  This evidence suggests that at


least Cr(VI) can alter DNA synthesis by more than a single mechanism.


     Loeb and coworkers  (Sirova and Loeb,  1976;  Loeb  et al., 1977) have demon-


strated that chromium compounds adversely affect the fidelity of DNA transcrip-


tion.  The compounds, CrCl..  and CrO,, were  incubated  with avian myeloblastosis


virus DNA polymerase, a  template  with restricted  base  composition,  and coraple-

                                            00
mentary  deoxynucleoside  radiolabeled with    P  and noncomplementary  deoxynuc-
                                     7-119

-------
leoside labeled with -*H.  Following  incubation,  the error frequency was deter-



mined to be greater when either metal  compound  was added to the incubation system



as compared  to the controls.   The error prone avian myeloblastosis virus DNA



polymerase lacks exodeoxynuclease active  for  removal  of  noncomplementary base,



thus  providing  optimum  conditions   for  detecting  the  nonfidelity  of  DNA



synthesis.   In  later  studies,  Tkeshelashvili  et al.   (1980)  demonstrated  a



similar  increase  in misincorporation  of complementary  bases  using synthetic



polynucleotides and CrO., and  CrClo in  an  assay system containing  E.   coli DNA



polymerase.   Both  compounds  appeared to  have  approximately  the same activity.



Nearest  neighbor  analysis   indicated  that   the  noncomplementary  bases  were



incorporated as  single base  substitution.    Noncomplementary  nucleotides were



also incorporated with native DNA from  bacteriophage $x17t  (am3) and  E. coli DNA



polymerase in  vitro in  the presence  of CrO,.   Infidelity  in DNA  synthesis was
           ~~"~  ~""^^~""~                        3


detected by loss of an  amber mutation  which was assessed by growth of infected



strains of E.  coli nonpermissive and permissive for this mutation.



     Tamino  et al.  (1981)  examined  the  in vivo and  in  vitro  binding  of both



Cr(VI) (K2Cr20_)  and (III) (CrCO to  DNA from cultured BHK  cell, and  in vitro to



commercial calf thymus  DNA and  synthetic  polynucleotides.   The interactions of



Cr(III) with these nucleic acids in vitro was dependent on the G and C content,



with synthetic poly(G)  and  poly(C) binding 1.05 chromium  ions  per 100 nucleo-



tides.  In vitro and in vivo reaction also changed the ultraviolet (UV) absorp-



tion spectra and  thermal stability of the  DNA.  When Cr(VI) was used there was no



observed change in the  UV spectra whether  exposure occurred in vitro or in vivo.



The manner of  treatment with Cr(VI) did affect the thermal stability of the DNA



with in  vitro  exposure resulting  in the same  types  of changes  observed with



Cr(III), while little  change  in thermal stability occurred with  in vivo exposure



to Cr(VI).  The data indicate that Cr(III) has some capacity  to cross biological
                                     7-120

-------
membranes and  interact  with cellular DNA,  and that the  types  of interactions



between chromium and polynucleotides may be different for Cr(VI) and (III).



     Although  in  vitro  mutagenicity  indicated   that  Cr(VI)  compounds  were



generally active and Cr(III) compounds nonactive, the assays of chromium induced



DNA damage  in the rec  assay,  unscheduled DNA  synthesis  in  mammalian cultured



cells, and increased  in  vitro infidelity of DNA synthesis indicated that at least



some activity is associated  with both valence states (Nishioka,  1975; Nakamuro et



al., 1978; Raffeto,  1977; Loeb et al., 1977; and Tkeshelashvili et al., 1980).








7.3.3.  Chromium  Induced  Chromosomal  Aberrations and  Cell Transformations.  In




vitro,  chromium has  been shown  to result  in the  appearance of  chromosomal



aberrations  and  cell  transformation  (Table 7-23).   Fradkin  et al.   (1975)



observed  morphologic changes and loss  of anchorage dependent  growth in BHK21



cells treated  with 0.25 and 0.5 pg  of CaCrCv»2H 0.  Chromate transformed cells



maintain  the ability  to grow independent of anchorage even after the cells were




re-isolated and freed of exposure  to CaCrO^»2H  0.  Tsuda and Kato (1977) observed



morphologic  transformation  in primary hamster embryo  cells after  exposure to




K2Cr_07(VI) at a level of 0.1, 0.2,  and  0.5 pg/mA for 24 hours.  The transforma-



tion frequency increased from 0.179$ for the control cultures  to  0.760, 2.86, and



2.70* for cells exposed to 0.1, 0.2, and  0.5 pg/m£, respectively.  A transforma-



tion  frequency of 2.10$  was  achieved with  the positive  control, N-methyl-N'-



nitro-N-nitrosoguanidine  (MNNG) at a level of 0.5 pg/mS,.   Conflicting  results of



exposure  to  CrCl-(III)  and  K Cr 0 (VI)  on morphologic  transformation of BALB/c



mouse "fetus cells in culture was obtained in two experiments  by  Raffetto (1977).



Although  both  experiments showed an increase in the number of transformed foci,



this increase  was  not dose-related, and  there was  a 10-fold difference between



the two experiments performed under  similar conditions.  The  authors suggest
                                     7-121

-------
                         TABLE 7-23



Chromium Produced Clastogenic Effects and Cell Transformation

Test
Cell transformation



Cell transformation




Cell transformation

Cell transformation


— j
I Host mediated cell
fij transformation
ru
Clastogenic

Clastogenic








Clastogenic

Clastogenic

Clastogenic


Indicator
Cells
BHK
C. \


primary embryo
hamster cells



BALB/c cells

primary embryo
hamster cells


primary embryo
hamster cells

BALB/c cells

CHO cells








mouse FM3A cells

hamster embryo
cells
V79 cells


Compound
Tested
CaCr
-------
                                                                        TABLE 7-23 (cont.)
OJ
Test
Clastogenic

,

Clastogenic


Clastogenic






Clastogenic




Clastogenic


Clastogenic


Clastogenic



Clastogenic

Clastogenic

Indicator
Cells
cultured human
leukocytes



cultured human
lymphocytes

CHO cells






Don Chinese
hamster cells



cultured human
lymphocytes

polychromatic
erythrocytes from
NMRI mice
gel cells from
Boleophthalmus
dussumierl

human lymphocytes

human lymphocytes

Compound
Tested
K Cr 0
KCrJL7
CNCH^COO)-

Cr(NO )
CrCI 3 3
K Cr 0
3

K CrO
NS Cr 6
K CrO^ '
Na-CrO,,
Cro,
CrCI
Cr(NO )
KCHSOJ
CKCOOCfC),
CrCl,-6H.O
Cr (SO^)g'
CrO2
K C?0y
K2Cr207
K CrO
CaCrO. '
CrO,
K CrO.


Ha Cr 0



CrO

CrO,

Valence
State
+6
+6
+3

+3
+3
+6
+6

+6
+6
+6
+6
+6
+3
+3
+3
+3
+3
+3
+6
+6
+6
+6
+6
+6
+6


+6



+6

+6

Dose
0.125 to 1.0x10"6M
0.5 to 8.0x10" M
1 to 32 x 10"bM
*
32.0 x 10"?M
32.0 x 10 M
-8 -"5
10 , to 10 ,M
10 to 10"^

0.1 and 0.3 pg/ml
0.1 and 0.3 pg/mfc
0.25 pg/mJ,
0.25 pg/mfc
0.1 and 0.25 pg/ml
5 and 50 pg/m«,
50 and 150 pg/mJl
150 pg/mfc
5 and 20 pg/mA
32 pg/mfc
6 pg/mH
0.32 pg/mJl
0.8 pg/mJl
0.8 pg/md
0.025 to 0.1 pg/mH
0.01 to 0.02 pg/mJ.
0.025 to 0.1 pg/m£
2 x H8.5 mg/kg, IP
2 x 21.25 mg/kg, IP
2 x 12.12 mg/kg, IP
1 or 5 mg/kg IM

21) or 30.5 ppm in
the aquarial water
Occupational exposure

Occupational exposure

End point
Chromosomal aberra-
tions



Chromosomal abbe ra-
tions

Sister chroma t id
exchange






Sister chroma t id
exchange



Sister chroma t id
exchange

Micronucleus test


Chromosomal aberra-
tions


Sister chromatid
exchange
Chromosomal aberra-
tions
Response Reference
+ Hakamuro
•«• et al.,
* 6 1978
at >16 x 10 ° M

-
+ Stella
et al. ,
1982
+ Lev is and
+ Ma Jone ,
+ 1979

+
-
—
-
+ Ohno et al.,
1982
+
+
•f
+ Gomez -Arroyo
+ et al., 1981
+
+ Wild, 1978
+
-
+ Krlshnaja
and Rege,

+
+ Stella et al.
1982
+ Sarto et al. ,
1982
     IP = Intraperitoneal Injection
     IM = Intramuscular injection

-------
caution in interpreting these findings.  Casto et al.  (1979), using a different



experimental system, demonstrated that the Cr(VI) compounds, CaCrOu, K?Cru, and



ZnCrOjj,  at  concentrations of 0.006, 0.01,  and 0.01 mM  enhanced  the  virally



induced transformation frequency of primary embryo hamster cells.  The increase



in transformations was -2 for the Ca and K salts, and 4 for the Zn salt.  Other



metals assayed that had no indication from the literature of genotoxic properties



did not enhance the rate of viral  transformation.



     Increase in cell  transformation has  also  occurred in  cells isolated from



hamster embryos exposed in utero to Cr(VI)  (DiPaolo and Casto, 1979).  Initially,




it  was demonstrated  that NaCrO^'^O  at levels  of  1.0,  2.5, and  5.0 pg/mfc



increased the  transformation  frequency  of  isolated  hamster  embryo cells  in



culture to  0.7,  2.1, and 3-48$,  respectively.   Following  this initial study,



pregnant Syrian golden hamsters (number not reported) were given intraperitoneal



injections of NaCrOj. at 2.5 mg/100 g body  weight on  day 11 of gestation.  It was



reported that cells isolated  from embryos excised 2 days later produced elevated



numbers of transformed colonies; however,  the data were not presented for these



studies.  It was concluded that transplacental  exposure to chromate resulted in



alterations of fetal cells.



     A number of studies  have also demonstrated  that exposure of cells in culture



to either Cr(VT) or (III) compounds produces chromosomal aberrations.  Raffetto



(1977) exposed BALB/c mouse  cells to CrCl-(III)  and K2Cr20,,(VT)  for either 48 or



96 hours. Increase in the number of chromosomal  aberrations was noted for Cr(VI)



at a level of 0.1 pg/mS,, but  not for Cr(III) at the same level after a 48 hour



exposure; however, with  96 hours  of exposure, Cr(III)  at  0.4 pg/mfc (0.04 pg/mS,



was also tested) and Cr(VI) at 0.1  and 0.015 pg/mJ, produced significant (P<0.05)



increases in the number of chromosomal aberrations.   Newbold et al. (1979) also



detected dose dependent  chromosomal  damage with K-Cr^O™ at  levels  between 0.35
                                     7-124

-------
and 0.8 pg/mfi, in V79 cells.   Similar results were reported by Levis and Majone



(1979),  in  which  both  Cr(III)  compounds  [CrClg,  CrCNO,).,  KCHSO)^, and




Cr(COOCH-K] and Cr(VI) compounds (KgCr-O™, Ua^CrJdy,  K^CrO^,  Na.CrO!,,  CrOo, and



CaCrOj.) produced increases  in chromosomal aberrations in CHO cells in  culture.



Again, Cr(VI)  compounds  were more active,  with  positive responses obtained at



doses  of  0.1  to  0.5  pg/mJl,  while  marginal  positive responses  with Cr(III)



occurred at  doses  of  5  to 150 pg/mJL   Although both  valence  states  produced



chromosomal  aberrations,  only  Cr(VI)  induced  increases  in  sister   chromatid




exchange, and even the increase observed  with  Cr(VI) was small in  comparison to



the response  elicited  by the positive  control,  Mitomycin  C.   Sister-chromatid



exchange was also  observed  by Ohno  et  al.  (1982)  in  Don Chinese hamster  cells



following treatment with the  Cr(VI)  compounds  CrO_, K-CrO^, and K^Cr 0- at con-



centrations of  0.32,  0.8,  and 0.8 pg/mJl,  respectively.   The  Cr(III)   compounds



CrCl-'SHpO and  Cr  (SO^)  »i»H 0 were  less active  than  the Cr(VI)  compounds at



levels of 32 and 6 pg/mfc, respectively, with the increases due  to the sulfate not



significantly elevated over control values.  Again, as in the previous study, the



levels of chromium  induced  sister-chromatid exchange was 10 times less  than that



of  the positive control,  mitomycin C.   However,  in  the study  by  Umeda and



Nishimura (1979), only the Cr(VI) compounds, KpCr 0_ and CrO_, produced chromo-



somal aberrations in mouse  FM3A cells, while K  CrO^(VI) was negative even at high



concentrations.  It is not clear why Cr(III) was negative in this study, although



these results may reflect a difference  in sensitivity of these cells.



     The effectiveness of  chromium compounds  in  producing  chromosomal aberra-



tions' was affected  by the valence state of the compound.  Tsuda and Kato (1977)



demonstrated that 0.5 ug/m& of K^Cr  0.  produced  chromosomal  aberrations in 51$



of hamster embryo metaphases examined; however, addition of the reducing agent,



Na2SO_, at a level  of 0.6^5 pg/mJl resulted in a decrease in abnormal metaphases
                                     7-125

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to 6%.  This provides further evidence that Cr(VI) was more active than Cr(III)



in producing chromosomal aberrations.



     Nakamuro et al.  (1978)  used peripheral blood  human leukocytes in short-term



culture to elevate the  clastogenic effects of a  number of Cr(VI)  and Cr(III)



salts.  Following isolation and 24 hours  of  culture,  the cells were exposed to




Cr(VI) (K2Cr207, KgCrOjj) and Cr(III)  (Cr(CH3COO)3, CrCNO^, CrCl3) chromium at



the  respective  concentrations of 0.125  to  4,   0.5  to 8,  4  to  32,  32,  and



32 x 10"  M.  Significant increases  (P<0.01) in  total  chromosomal aberrations



were observed at  the higher doses with all  compounds except  Cr(NO_),(III) and



CrCl.,(III).  It was apparent that human leukocytes responded similarly to other



cultured cells in regard to sensitivity to chromium induced chromosomal aberra-



tions.



     In vivo  clastogenic activity of KCrCL has  been observed in  mice  by the



micronucleus test (Wild, 1978).  NMRI mice (4 animals of each sex) were treated



by two intraperitoneal injections of  0.0,  12.12, 24, 25,  or 48.5 mg/kg of K CrCL




in saline, followed  in  6 hours by  examination of  bone marrow for micronucleus-



containing erythrocytes.  Of the 1000 cells examined per mouse, there were 3.1,



4.8, 9.6,  and 15.0$ micronucleated  polychromatic erythrocytes  in the control and



treated animals,  respectively.   The  responses  in the  two  highest  dose groups



represent significant increases over  control values.   Chromosomal aberrations,



including  breaks,  fragments,  rings,  exchanges and  unclassified  makers,  were



observed in the gills  of the fish Boleophthalmus dussumieri  after exposure to



sodium dichromate(VI) (Kushnaja and Rege,  1982).  The number of total aberrations



increased from 1 to  6 and 16 after intramuscular  injection of Na-Cr 0_ at doses



of 0.0, 1, and 5 mg Cr/kg, respectively.   Increases in total aberrations of  0, 7,



and  7  were  also observed when the fish  were maintained in water  for 96 hours



containing  chromium  at levels of  0.0,  24.0, or  30.5 ppm  (the high dose  level
                                     7-126

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killed 50%  of the  fish).   Other  heavy metals  and  mitomycin C  also produced

chromosomal aberrations in this test system.

     Human  lymphocytes  exposed either  in vitro  to  chromium or  isolated from

workers  occupationally  exposed to  chromium  have  been  used  to  investigate

chromium induced chromosomal damage.  Increase  in both sister chromatid exchange

and chromosomal aberrations were observed when cultured human lymphocytes were

exposed to  the Cr(VI)  compounds K2Cr207>  CaCrO^, and Cr03 (Gomez-Arroyo, 1981;

Stella etal.,  1982;  Littorin  et  al.,  1983);  however, the  Cr(III)  compound,

CrCl.,, was  totally inactive  (Stella et al.,  1982)  in this  assay.    In blood

samples taken from workers in the chromium plating industry  (Stella et  al., 1982;

Sarto et  al., 1982) there were increases in chromosomal changes in  the  peripheral

lymphocytes.  Stella et al.  (1982) obtained blood samples from 12 male workers

and  10 control donors not  exposed to chromium.   There  was  no  significant

difference  in the  incidence of  sister chromatid exchange in the 5 older workers

(24 to 47 years of age); however,  in the  7 youngest  workers  (17  to 23 years of

age)  there   was  a  significant increase.    The  control  subjects  had  an  age

associated increase in sister  chromatid exchange, while  the level  in the exposed

population  appeared  constant.    Sarto  et al.   (1982)  studied  the   peripheral

lymphocytes of workers in two "hard" plating (one of the plants was the same as

that studied by Stella et al.,  1982)  and two "bright" plating industries.   In the

"hard" plating industry, exposure  was to  chromium alone,  while  in the "bright"

plating industry  the  workers  were  also exposed  to nickel.   As  in the previous

study, the younger workers had  significant increases in chromosomal aberrations

while  the  number  of  aberrations  was not significantly elevated from control

levels in the older workers.   There was  also a positive  association between

urinary chromium  levels and the number of chromosomal aberrations  in the two

"hard" plating plants.   The  authors   concluded  that   these  data support  the

genotoxicity of the soluble Cr(VI) ion.
                                     7-127

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     Venier et al. (1982) tested  10 Cr(III)  compounds  used in leather tanning,



and  one  Cr(III)-chromite  compound  used   as  a   pigment,   for  cytotoxicity



(inhibition and growth and survival of cultured hamster cells), mutagenicity (S.



typhimuriam),  and clastogenic  activity  (chromosomal  aberrations  and  SCEs).



Generally, the trivalent compounds were only  slightly cytotoxic.  The hexavalent



reference compounds,  potassium  dichromate,  had  a cytotoxic activity  at  0.5 ng




Cr(VI)/m£ (ID50 for growth)  and 0.2 pg Cr(VI)/mA (LD50  for cell survival).  For



the  trivalent  compounds, 100  to  500  times  greater amounts  were  required to



inhibit growth or destroy the cells.  Only two trivalent compounds (chromite and



chromium nitrate) were mutagenic;  however, both compounds were contaminated with



Cr(VT).   Again,  the  frequency  of SCEs  was  increased  only  for  the  Cr(III)



contaminated with Cr(VI).  Only the chromium nitrate reference compound and the



weakly  contaminated  Cr(III)  compounds  caused  an  increase  in  chromosomal



aberrations.   The authors  concluded  that hexavalent  chromium  compounds were



primarily responsible for the genotoxic effects of chromium.




     In  contrast,  Elias  et al.  (1983)  found  that a  range  of 9  to  136 fig



Cr(III)/mJl  caused a significant increase in SCEs,  but, as  seen by Venier et al.



(1982) and Ohno  (1982),  this only occurred at  trivalent  chromium levels  300 to



1000 times higher than that required by Cr(VT) compounds.








7.3.4.   Summary.   In  vitro and in vivo assays  of genotoxicity have tried to



clarify  the  mechanism  of  chromium  carcinogenicity  and  have  supported  the




potential for Cr(VI)  to  be  the  active carcinogenic species.   Cr(VT) has  demon-



strated  consistently  postive  mutagenic  activity  in  a  number of  bacterial



systems.  This activity was demonstrated in the absence of a metabolic activation



system.  In the presence of  a metabolic activation system,  the mutagenic activity



of Cr(VI) disappeared.  Because chromium shows only marginal, if any, mutagenic
                                     7-128

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activity after metabolic activation,  it was suggested that the mammalian enzymes



or cofactors in the activation system reduced Cr(VI) to  Cr(III).   Both Cr(III)



and Cr(VI) have been demonstrated to interact with DNA in bacterial assays, and



Cr(VI) has  inhibited  DNA synthesis and increased unscheduled  DNA  synthesis in



mammalian cells in culture.  In in vitro  studies, both Cr(III) and Cr(VI) have



increased the infidelity of DNA replication.  As observed with interaction with



DNA,  both  valences of  chromium have been demonstrated  to  produce clastogenic



effects  in  mammalian cells  with  Cr(VI)   being  more active than Cr(III).   The



effects observed included a variety of chromosomal aberrations, sister chromatid



exchange,  and  the appearance  of micronuclei  in  polychromatic  erythrocytes.




Increased  chromosomal  damage  also  has  been  observed  in  human  lymphocytes



cultured from subjects occupationally exposed to chromium.  For all the observed



genotoxic effects,  it has been suggested that  Cr(III) may be the predominant



intracellular species as a result  of  the reduction of absorbed Cr(VI) by cellular




components.








7.4. DEVELOPMENTAL TOXICITY AND OTHER REPRODUCTIVE EFFECTS








7.4.1.  Developmental Toxicity.  Chromium salts have  been shown  to be teratogenic



and  embryotoxic in mice and hamsters  following intravenous  or intraperitoneal



injection.



     In  one  study,   golden  hamsters  were  given  single  intravenous  CrO.(vi)



injections  of 5,  7.5,  10,  or  15 mg/kg on  the  eighth day of  gestation  (Gale,



1978)!   Treatment  groups were as follows:   15 dams exposed  (5 mg/kg), 18 dams



exposed  (7.5 mg/kg),  21 dams exposed (10  mg/kg), and 4 dams exposed (15 mg/kg).



In  all  but  the  5 mg/kg  group,  dams  exhibited signs  of chromium  toxicity,



including weight loss and tubular  necrosis of the kidneys.  The highest dose was



lethal to 75$ of the  dams.





                                     7-129

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     Chromium given on the eighth day  of  gestation resulted in increased fetal



wastage at doses of  >7.5 mg/kg.(statistics not reported).   The  major external



anomaly noted was cleft palate.  Incidence was significantly elevated above the



control level for all treated groups (method not stated).  The primary internal



abnormality recorded was hydrocephaly,  with an increased incidence noted in all



treatment groups.  In addition, a wide  range of skeletal defects was noted.



     In a second study, golden  hamsters were given intravenous CrO_ of 8 mg/kg on



day 7, 8, 9,  10  or  11 (Gale and Bunch, 1979).  Six pregnant female hamsters were



treated  in  each time-group  with  three concurrent  controls.  Fetal  death was



greatest in litters treated on the seventh  day  of gestation when there was an 8U$



incidence of resorptions.   Resorption incidence was elevated to a small degree on



days 8 and 9 (20 and  13?, respectively), but was not affected on days 10 and  11.



     As in the previous study,  cleft  palate  was the primary external abnormality



recorded, occurring most frequently  in litters from dams  exposed on day  7 of



gestation and at elevated incidence rates  with respect  to controls on days 8 and



9, but not on days 10 and 11  (determined based on tables of binomial confidence



limits).  The  only internal  abnormalities noted were  kidney defects in groups



exposed on days 7 or 8 of gestation.  Group sizes were too small to establish a



significant difference from controls.  As  in the previous study, treated females



exhibited signs of chromium toxicity  which included body weight loss and tubular



necrosis of the kidneys.



     In  a  continuation of this work,  Gale (1982) tested  Cr(III)  in noninbred




(LVG) and inbred (CB, LHC,  SDH, MHA, and PDU)  strains of hamsters for reproduc-



tive  and  teratological effects.  The  dams (10 animals/group)  were treated by



intravenous injection on the  8th day of gestation with a single dose of 8 mg/kg



of  Cr(III).   On  termination at day 15  of gestation, it  was  determined that



strains CB, LHC, and PDU  were resistant to any adverse effects of treatment.  In
                                       7-130

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the other strains, LVG, LSH, and MHA  there  was  an increased incidence of cleft



palate (33,  18, and  15  animals,  respectively,  while control groups had no more



than 1 pup/group with cleft palate) and other external abnormalities<.  The dams



of  the  strains with  the  highest  incidences  of  fetal abnormalities  also lost



weight during the period  of gestation following treatment.   Strain differences



were reported  for the  reproductive effects of other metal compounds in these



animals; however, the  genetic  mechanism which  results in  these differences in



susceptability was not understood.



     Matsumoto et al.  (1976)  administered  chromium chloride (+3),  19.52 mg/kg



(as Cr), intraperitoneally  to ICR  mice  on  day  7,  8, or 9 of gestation.   Eight



control dams received a saline injection.  Treatment group sizes were 5,6, and 7



on days  7,  8,  and 9, respectively.   The  embryonic and fetal  death  rates were



elevated following treatment on days 8 and 9 (P<0.001, method not stated).  The



incidence of external malformations was significantly greater than  in controls



in litters of dams exposed  on day  8 of gestation (P<0.001, method not stated).



Recorded anomalies included  exencephaly and open eyelids.  In addition, there was



a small increase in  skeletal defects in litters from dams treated on days 8 and




9.



     In a second  experiment, pregnant  dams were  given intraperitoneal injections



of chromium chloride as dose levels  of  9-76,  14.64, 19.52, or 24.4 mg/kg as Cr on



day 8 of gestation.   Group sizes  were:  control  (11  dams), 9.76 mg/kg (13 dams),



14.64 mg/kg (13 dams),  19.52 mg/kg  (7  dams), 24.4  mg/kg (9 dams).  Fetal weights



were significantly reduced in all treatment groups  (P<0.05, method not stated).



The incidence of external malformations was significantly  greater than control



values for the 14.64  mg/kg dose group  and all higher dose groups (P<0.05, method



not stated).   Anomalies  with  greatest incidence in rats  were  open eyelids,



exencephaly, and acephalia.  In  addition,  skeletal  defects  were noted in these



same groups.




                                    7-131

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     lijima et al. (1979) dosed pregnant ICR mice with CrO,(VI) by subcutaneous



injection.  Mice were  injected with a single 10 or 20 mg/kg dose on day 7, 8, 9,



10, or 11 of gestation.  The 20 mg/kg dose was lethal to one-third of the dams.



In this  group,  a significant  increase  in external  anomalies was  recorded  in



litters from dams exposed on day  8 of gestation.   Cleft palate was the primary



abnormality.  In addition, increased  fetal and embryonic death rates were noted



in groups exposed to 20 mg/kg on day  8 or day 11.



     The studies discussed in the text above are summarized in Table 7-24.



     lijima  et  al.  (1983)  found that  radiolabeled chromium levels  in  fetal



tissues  increased,  while  levels  in maternal blood  decreased  after  single



intraperitoneal injections of 9-8 mg Cr (  CrCl-)/kg body  weight at gestation day



8.  Their findings indicated that CrCl  could affect embryos directly and cause



neural tube  defects.   They  noted also that pyknotic cells  on the neural plate



could indicate the development of exencephaly.



     Danielsson et al. (1982) found considerable differences between Cr(III) and



Cr(VI) in their distribution in embryonic and fetal uptake.  Forty-two pregnant



mice received single doses (5 pg/kg i.v.) of CrCl, or Na_Cr_07 on days 8 to 18 of



gestation.  On day 13  of gestation, embryonic concentrations were 12$ Cr(VI) and



0.4$ Cr(III).  Fetal concentration of both compounds increased with gestational



age,  probably binding  to fetal  calcified bone,  which  develops  on day  14.



According to the authors, it appeared that Cr(VI)  occurred at sufficiently high



fetal concentrations  to  cause  direct  effects on  embryonic  sturctures,  i.e.,



delay in skeletal development by inhibition of cartilage  formation.  Cr(III), on



the other hand,  was  not detected in embryonic structures during early gestation,



but it .could act on  placental structures and thereby affect fetal development.




     As  discussed  previously   (Section   5.2.1.),   there  are   limited   data



demonstrating transfer across the placenta.  It should be pointed out that most
                                     7-132

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                                                                             TABLE 7-21


                                                           Teratogenic and Fetotoxic  Effects of Chromium
u>
UJ
Compound Route Species
CrO- i.v. hamster
CrO, i.v. hamster
CrCl, i.p. mouse
CrO. i.v. hamsters
j (strain
LVG)
hamsters
(strain
CB)
Dose
5, 7.5, 10,
or 15 mg/kg
on day 8 of
gestation
8 mg/kg on
day 7, 8, 9,
10, or 11 of
gestation
9.76, 14.61,
19.52, or 21.1
mg/kg on day
8 of gestation
8 mg/kg on day
8 of gestation
8 mg/kg on day
8 of gestation
Fetal Effects
increased fetal death in
7.5, 10, and 15 mg/kg
groups, increased incidence
of cleft palate in all
groups, hydrocephaly and
skeletal defects
increased fetal death
following administration
on day 7, increased
Incidence of cleft palate
following administration on
days 7, 8, or 9
depression of fetal weights
in all Cr treated groups,
increase in rate of external
abnormalities for groups
treated with 11.61, 19.52,
or 21.1 mg/kg
increased incidence of cleft
palate
no effect
Maternal Effects Reference
depressed weight gain and Gale, 1978
kidney tubular necrosis
at all doses above 5 mg/kg
weight loss, tubular necrosis Gale and Bunch, 1979
of kidneys
not reported Matsumoto et al., 1976
body weight loss Gale, 1982
no effect

-------
                                                                          TABLE  7-21  (oont.)
-4
 I
oo
.«=•
       CrO.
ound Route Species
hamsters
(strain
LHC)
hamsters
(strain
LSH)
hamsters
(strain
PD1)
hamsters
(strain
MHA)
s . c . mouse
Dose
8 rag/kg on day
8 of gestation
8 mg/kg on day
8 of gestation
8 mg/kg on day
8 of gestation
8 mg/kg on day
8 of gestation
10 or 20 mg/kg
on day 7, 8, 9,
10, or 11 of
gestation
Fetal Effects Maternal Effects
no effect no effect
increased incidence of cleft body weight loss
palate
no effect no effect
increased incidence of cleft body weight loss
palate
increase in external tnalfor- lethal to 1/3 of dams
mations in 20 mg/kg group
when dosed on day 8, as well
as increase fetal death when
dosed on day 8 or 11
                                                                                                                                  Reference
                                                                                                                                  lijima et al., 1979

-------
                                                                          TABLE 7-21 (cont)
U)
Ul
         Compound
        Na Cr 0
        (cKvi)S
        Cr(VI)
                      Route
         CrCl          i.p.
         CrCl          i.p.
        CrCl         i.v.
i.v.
          Species
                                           Dose
                               mouse
                               mouse
                                [in
                                vitro]
          [in
          vitro]
                      9.8 mg/kg  on
                      day 8 of ges-
                      tation
          mouse       19.5 mg/kg/day
                                           10 mg/kg on
                                           days 13 and
                                           16 of ges-
                                           tation
                      0 to 15 pg/mfc
0.1 to 0.28
pg/mi.
                                                             Fetal Effects
                  Cr increased gradually and
                  peaked at 21 hr, exceeding
                  maternal blood Cr level.

                  Pyknotic cells in neuro-
                  epithelium of neural ecto-
                  derm in 2 of 5 embryos
                  after 1 hr; in all 5, after
                  8 hr.

                  Fetal Cr(III) was 0.1* of
                  maternal serum Cr 1 hr post-
                  i.v.; high accumulation of
                  Cr in yolk sac placenta.  In
                  late gestation, Cr accumu-
                  lated in calcified areas of
                  fetal skeleton.
                  No overt cytotoxicity at
                  pg/mX, in embryonic cell
                  cultures (chick cells).
                         15
Fetal Cr(VI) was 12* of
maternal serum Cr 1 hr post-
i.v.  In late gestation, Cr
accumulated in calcified
areas of fetal skeleton.

Affected cartilage produc-
tion at =0.1 pg/rai in em-
bryonic cell cultures
(chick cells).
        i.v. = intravenous; i.p. = intraperitoneal; s.c. = subcutaneous

        NR = Not reported; NA = Not applicable
                                                                                              Maternal Effects
                                 Maximum blood Cr at 1 hr
                                 post-i.p. and gradually de-
                                 creased

                                 NR
                                                                                              NR
                                                   NA
                                                                        NR
NA
                                                                                     Reference
                                  lijima et al., 1983
                                  lijima et al., 1983
                                                                                                          Danielsson et al.,  1982
                                  Danielsson et al., 1982
                                                                                     Danielsson et al.,  1982
                                                                                                                                Danielsson et al.,  1982

-------
studies  have  sampled  fetuses  near  the  end  of  gestation,  not  early  in



organogenesis when  the fetus may  be  more susceptible to  teratogens.   Further



research is clearly  indicated to further define the nature and extent of possible



chromium teratogenesis and embryo toxicity.








7.4.2.  Other Reproductive Effects.  Behari et  al. (1978) examined the effects of



chromium   on  testicular   tissue   in   rabbits.      Animals  were   injected



intraperitoneally with chromium nitrate  or  potassium dichromate  at doses  of



2 mg/kg for  3 or 6 weeks.   Both forms of chromium resulted in a decrease in



testicular succinic dehydrogenase  at  3 and 6 weeks.   ftdenosine triphosphatase



was inhibited at both time points with both compounds, but the Cr(III)  compound



resulted  in  more  severe  depression.    Acid  phosphatase  was  significantly



depressed at 6 weeks in animals given the trivalent salt.



     The administration of Cr(III)  resulted in thickening of the tunia albuginea



and congestion of blood  vessels following 3 weeks  of  treatment.   In addition,




cells in the seminiferous epithelium showed degenerative changes.  At the 6 week



time point,  these degenerative changes were  more  pronounced, and  there  was a



complete absence of spermatocytes in the  lumen.  Cr(VI) produced mild  edema of



the interstitial tissue of  the testes at 3 weeks. Following 6 weeks of exposure,



edema was more marked and congestion of the blood vessels  was  noted.   Although



the seminiferous epithelium appeared normal,  the tubules  were devoid of sperma-



tocytes.                                                 ^



     Hopkins  (1965)  postulated  that incorporation  of chromium into sperm and



subsequent passage  into  the  epididymis may be  a problem.   This hypothesis  is



based .upon observation of chromium uptake by  testis, subsequent decline of tes-




ticular  radioactivity,  and  subsequent  increase  in  radioactivity   in  the



epididymis  (see  Section 5.2.2.).    Gross  and  Heller  (19^6)  have  reported
                                     7-136

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sterility in rats  exposed  to zinc chromate and  potassium chromate in the diet




(Section 7.2.5.).







7.4.3.   Summary.  Chromium  has  adversely affected  fetal development and male



reproduction in  experimental animals.   Hamsters  administered chromium trioxide



intravenously on day 8 of gestation had an increased incidence of cleft palates



in the young when examined on day 15 of gestation.  The malformations were strain



specific and associated with maternal toxicity.  Studies  on the mouse indicated



that  while  some skeletal  effects were  present,  increased  incidence  of cleft



palate or fetal  death were not observed.  While several of the studies reported



fetal  malformations  only  where  maternal  toxicity  was  also present,  not  all



studies reported data on maternal effects, so definitive  conclusions concerning



the correlation  if any between fetal and maternal effects  cannot be made at this




time.



     Other  reproductive  effects  of chromium include testicular degeneration in




rabbits receiving  2 mg/kg/day for 6 weeks of either Cr(III) or Cr(VI) compounds



by intraperitoneal injection.  The Cr(III) compound  produced more severe effects




in this study than did the  Cr(VI)  compound (Behari et al.,  1978).  The relevance



of  these observations   to  effects  observed  after  environmental  exposure  is



questionable,  as is  that  of the previously discussed  teratogenicity studies,



since the routes of exposure were not natural.  There is clearly a  need for more



relevant studies on the  route of exposure than are presently available.








7.5. OTHER  TOXIC EFFECTS OF  CHROMIUM








     The  literature  concerning  chronic  and  subacute  exposure   to  chromium




consists primarily of reports  of no observable effect levels (NOEL).  Although
                                     7-137

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the kidney and liver have  been  shown to be targets  following acute exposures,



reports of pathology in these organs  following  long-term exposure via relevant



routes  were  not  found.    There  are  two  reports which  suggest  effect  levels



following oral exposure; these studies are summarized in the following text.  The



numerous studies which suggest free  standing  NOAELs  are of limited  value  as a



result of experimental design and are summarized in Table 7-25.




     Gross and Heller (1946)  reported  that 0.125$ K^rOjj in the feed of rats was



tolerated without observable effects, 0.25$ resulted in "subnormal condition",



including rough coat and "subnormal" young born to treated animals.  Doses of 0.5



and 1$ resulted in diarrhea, rough  dirty  coats,  and  sterility.  ZnCrCK  adminis




tered in the feed at levels of 0.125, 0.25,  0.5, and  1.0$ resulted in subnormal



appearance, rough  and  dirty coats,  and sterility at  all  dose levels.   Group



sizes, duration of treatment, and criteria  for determining sterility  were not



reported.



     Ivankovic and Preussman  (1975)  administered  Cr  0_ to rats in their feed.




The compound was prepared by  incorporating it  into bread dough at levels of 2 or



5$.   In a 2-year study  (600 feeding days),  it was  estimated that  for  the 2$



treatment  level,  males consumed  75 g/kg  (25  g/animal)  over  the  entire study



period and  females consumed  72  g/kg (18 g/animal);  at the  5$ treatment  level,



males consumed 180 g/kg and females 160 g/kg  for  the duration of the study.  Body



weights were monitored and animals  were maintained on normal  rations following



the treatment period.  At  death,  animals were autopsied  and  "all  the important



organs" were studied  for micropathology. In addition, a 90-day study  was conduc-



ted also using bread levels of 2 or 5$.   In  this study, urinary protein,  sugar,



bilirubin, blood, and  sediment were monitored.   During the last 30 days of the



study, treated animals  were mated and the number  of viable young produced  in each



litter was  recorded.   At the end of treatment,  blood samples were analyzed for
                                     7-138

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            TABLE 7-25

Studies Suggesting NOAELS or NOELS
Species
mouse
mouse
rat
(young)
rat
(young)
— a
^ rat
OJ
vo
dog
Route
drinking
water
feed
drinking
water
feed
feed
drinking
water
Compound Dose Duration
K,CrO,. 100, 200, 300, N.S.
* 300, 100, or
500 ppm
ZnCrOy 1J N.S.
K CrO,. 300 and 500 ppm N.S.
KgCrO,, 0.125* N.S.
Cr20- 0, 1, 2, or 5> 2 years
K CrO, 0.15, 2.25, 1 years
2 4 1.5, 6.75,
or 11.2 ppm
No. at
Start
N.S.
N.S.
N.S.
N.S.
60/
group
2/group
End points
Monitored
general appearance,
reproduction
general appearance,
reproduction
general appearance,
reproduction
general appearance,
reproduction
gross and micro-
scopic pathology,
body weights
urtnalysis including
albumin, acetone,
bile pigments
Result Reference
NOEL for all Gross and Heller, 1916
doses
NOEL Gross and Heller, 1916
NOAEL; slight Gross and Heller, 1916
roughness of
coal at 500 ppm
NOEL Gross and Heller, 1916
NOEL Ivankovic and Preussman,
1975
NOEL Anwar et al., 1961
                   glucose,  indican
                   erythrocytes, and
                   specific  gravity;
                   gross and micro-
                   scopic pathology of
                   adrenals, bone
                   marrow, brain, heart,
                   intestine, kidney,
                   liver, lung,
                   mesenteric lymph
                   node, parathyroid,
                   pancreas, spinal cord,
                   spleen, stomach,
                   thyroid,  and tonsils;
                   weights of liver
                   spleen and kidney

-------
                                                                  TABLE 7-25 (cont.)
Species
rat










No. at
Route Compound Dose Duration Start
drinking K-CrOtt o, 0.45, 2.2, 12 mo highest
water * H i|.5, 7.7, 11 dose 9
and 25 ppm females,
12 males
control
10 of
each sex,
all other
groups , 8
males, 8
females
End points
Monitored Result Reference
clinical blood NOEL MacKenzie et al., 1958
chemistry, body
weights gross and
microscopic patho-
logy






I

*r
O
rat
cat
             drinking    CrCl.,
             water
0, 25 ppm
             feed
                         chromium    50 to 100
                         carbonate,  mg/cat/day
                         chromium
                         phosphate
cat
             inhalation
                         chromium
                         carbonate
                         dust
from 3.3 to
to 83 mg/m3
average 58.3
mg/m3
12 mo
                 1  to 3
                 mo
             12 males,  clinical chemistry
             9 females  body weights, gross
                       and microscopic
                       pathology
             10
86 ses-
sions
which
varied from
10 to 60
min and
averaged
28 min
for one
cat and
57 min
for the
other
organ weights
macroscopic patho-
logy microscopic
pathogy of lung,
heart, liver, stomach,
spleen, pancreas,
kidney, brain,
skatal muscles

gross and micro-
scopic pathology
                       NOEL
                                               NOEL
                                                                                   MacKenzie et al.,  1958
                                                                   Akatsuka and  Pairhall,
                                                                   1934
                                                                                                            NOEL
                                                                                                                                Akatsuka and Fairhall,
                                                                                                                                1934

-------
blood sugar, serum protein, serum bilirubin, and haemoglobin.  Erythrocytes and



leukocytes were counted.  Liver, spleen, kidney,  brain, and ovaries were weighed,



fixed, and sectioned at autopsy.   In  addition,  lung,  heart, pancreas, stomach,



small intestine, and urinary bladder were also fixed and sectioned.



     In the 90-day study, the only treatment related effect was a depression of



spleen and liver weights.   Spleen weights appeared to be depressed at both doses



in both sexes.   Liver  weights  appeared to  be depressed in both dose groups for



females and in high dose males.   Statistical  analyses were not reported.  In the




2-year study, no treatment related effects were reported.



     Berry  et  al.  (1978)  examined localization of  chromium within the kidney.



Rats  were dosed  by intraperitoneal  injection  with  0.1  mg  potassium dichro-



mate/100 g body weight.  Doses were given 5 times per week for 8 months.  Chromium



was  localized  within  cells of the proximal  renal  tubules,  specifically within



lysosomes.   Chromium  was  retained throughout most  of the  study  period,  being



eliminated only when necrosis involved the entire cytoplasm  of the tubule cells.








7.5.1.  Respiratory Effects.   Steffee  and Baetjer (1965) exposed rabbits, guinea



pigs,  rats,  and mice  to mixed  chromate  dust via  inhalation or intratracheal



injection.    Inhalation  exposures  were  conducted  5 hours/day,  4 days/week



throughout  the lifespan  of  the  animals.    The  average air  concentration was



estimated to be 3 to 4  mg  of  CrO  /m .   The average weekly exposure was estimated



to be  53,  44,  and  49 rag/hour for rabbits,  guinea pigs, and rats, respectively.



The  following exposure related effects were documented  in the lungs of exposed



animals.  Fifteen  percent  of the rabbits and rats in the inhalation exposures,



and  rabbits  and  guinea pigs  in the intratracheal groups exhibited granulomata.



This lesion was found in only one control rat and in none of the rabbits  or guinea



pigs.  The incidence of alveolar and interstitial inflammation was greater than
                                     7-141

-------
controls in guinea pigs exposed  via  both routes.  Exposure  related effects in


liver, kidney, and spleen were not found.


     Nettesheim et al. (1971)  exposed mice to calcium chromate dust 5 hours/day,


5 days/week for life.  The exposure concentration was 13 mg/m  of CaCrOj..  This


exposure concentration depressed  weight gains.  Exposed  animals  showed marked


alterations in the epithelium of the bronchial  tree after 6 months of exposure.


These alterations  were  graded from  epithelial  necrosis and atrophy  to marked


hyperplasia.  In addition, bronchiolization of alveoli (bronchiolar cells lining


alveolar walls) was observed.   Another  frequently  observed  effect was alveolar


proteinosis.  In addition to  lung  effects, morphological  changes  were noted in


the tracheal submandibular lymph nodes.  After  2 years  of exposure, spleen and


liver were  atrophied.   Ulcerations in  the  stomach and intestinal  mucosa were


noted occasionally.


     Early historical recognition of  the ulcerative property of Cr(VI) compounds


in  humans  is  evidenced  by  several   studies  on  the  subject  (Becourt  and


Chevallier, 1863; Delpech and Hillairet, 1869:  Legge, 1902).


     Bloomfield and  Blum  (1928) reported on  23 men  employed  in  six chromium


plating plants in the United States.  Their findings are  presented  in Table 7-26.


They concluded that continuous daily exposure to chromic acid at concentrations


>0.1  mg/m   is  likely to  cause  nasal   tissue  injury.    As can  be  seen from


Table 7-26, no concentrations <0.12 mg/m  were  observed; hence, injury to nasal


tissue caused by lower concentrations could  not be ruled out.


     Four of 33 chromium  platers were found to have septal perforation, although


the highest measured  concentration of  chromium trioxide in the  workplace was

          3
0.003 mg/m  .  Of the  33 workers, six had what the author considered to be normal


noses.  He  suggested that in view of  the low chromium concentration, the lesions
                                     7-112

-------
                            TABLE  7-26
Clinical Findings in Workers Employed in Chromium-Plating Plants
Time Employed in
Case
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
Chromium-Plating Time Over
Occupation Room, mo Tank, h/d
Chromium plater
Chromium plater
Foreman plater
Foreman plater
Chromium plater
Chromium plater
Chromium plater
Chromium plater
Chromium plater
Chromium plater
Chromium plater
Chromium plater
Chromium plater0
Chromium plater
Nickel platerd
Backer
Backer
Backer
Wiper
6
20
7
8.5
3.5
0.75
0.25
7
3
36
5
0.75
12
0.67
1.5
8
0.75
0.75
1.5
4
4
2
3
t
7
7
7
7
1
6
6
4
2
0
0
0
0
0
Approximate
CrO, Exposure, Perforated
mg/m Septum
1.5 ++
2.8 -M-
2.5
2.5
5.6
0.12
0.12
0.12
0.12
0.2
0.12
0.12
2.8
2.8
?
7 +•
?
?
?

Ulcerated Inflamed
Septum Muoosa Nosebleed
++ Yes
+ Yes
++ ++ Yes
++ ++ Yes
+> +•+• Yes
++ Yes
++ Yes
+-•• Yes
++ No
++ No
+ Yes
+ No
No
No
+ + Yes
+ Yes
+ No
+ No
+ No

Chrome
Holes
Yes
Yes
No
No
Yes
Yes
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No

-------
                                                                    TABLE 7-26 (cont.)

Case
20
21
22
23

Occupation
Foreman6
Foreman6
Clerk6
Inspector6
Time Employed in
Chromium-Plating
Room , mo
0
0
0
0

Time Over
Tank, h/d
0
0
0
0
Approximate
CrO, Exposure, Perforated
mg/ffl Septum
0
0
0
0

Ulcerated
Septum
-
-
-
-

Inflamed
Mucosa Nosebleed
+• NO
+ No
No
+ No

Chrome
Holes
No
No
No
No
"Source:  NAS, 1971a
c++, marked; 4-, slight; -, negative.
.Used vaseline in nose.
 Cyanide burns
 Worked in other departments of factory
mo = month; h = hour; d = day

-------
that resulted were due  to  exposure to periodic high concentrations of  chromium




trioxide that occurred when ventilation of the tank failed  (Lumio,  1953).




     Anodizing operators exposed to concentrations of chromic acid  mist ranging




from 0.09 to 1.2 mg/m3  (as CrO  ) developed ulceration of the nasal  passages and




atrophic rhinitis (Gresh,  1944; Zvaifler, 1944).




     The United  States Public  Health Service conducted a  study on workers in




seven chromate-producing plants in the  early  1950's.   The results are  shown in




Table 7-27.   Unfortunately,  the  results of  the physical  examinations on the




workers  were  not related  to  chromium  exposures,  and  hence,  the  data are of




limited usefulness (Federal Security  Agency,  1953).




     Mancuso (1951) reported  on physical  examinations  of a random sample of 97



workers from a chromate-chemical  plant.   It can be seen from the results which




are presented in Table 7-28, that  61 of  97 workers  (63$) had septal  perforation.



The data suggested to the author that Cr(III) may be partly responsible for the




perforations; however, later studies  have not provided support for  this theory.




     The results of examinations  of nine workers in a chrome-plating plant are




shown in Table 7-29.   Analyses of air samples showed chromium concentrations of




0.18 to 1.4 mg/m .  Some degree  of  nasal septal ulceration was seen in 7  of the 9




men, with 4 of 7 demonstrating  frank  perforations  (Kleinfeld and Russo, 1965).




Unfortunately, the effects of chromium for a specific length of time at a fixed



concentration were not studied.




     In  a  Russian study  conducted by  Kuperman  (1964),  10 apparently normal




persons were exposed to Cr(VI)  aerosol  concentrations  of non-reported composi-




tion 'ranging  from 0.0015  to 0.04 mg/m  .   Air  containing Cr(VI)  at  0.01  to




0.024 mg/m  sharply irritated the nose when inhaled for short  periods of time.




The most sensitive person responded  at  a chromium concentration of  0.0025 to
                                     7-145

-------
                                               TABLE 7-27




                            Perforation of Nasal Septum in Chromate Workers*
All Workers



—5
i
jr




Time Worked
in Chromate
Industry
<6 months

6 months to
3 years
3 to 10 years
>10 years
TOTAL

Total
No.
41


117
370
369
897
Workers with
Perforation
No. £
2..


46 39.3
205 55.4
257 69.6
509 56.7
White Workers
Nonwhite Workers
Workers with
Total
No.
32


89
235
297
653
Perforation
No.
0


28
104
190
322
%
0


31.5
44.3
64.0
49.3
Total
No.
9


28
135
72
244
Workers with
Perforation
No.
1


18
101
67
187
*
11.1


64.3
74.8
93.1
76.6
•Source:  NAS, 1974

-------
                                      TABLE  7-28

                   Perforation  of Nasal  Septum in  Chromate  Workers*
   Ratio of
 insol Cr*-: to
         +6
   sol Cr
Workers in plant
Chromium Concentration,
   mg/m  (as Cr)
•Source:  NAS, 1974
insol = insoluble; sol = soluble
No. Workers
Examined
Workers with
Septal Perforation
 No.         %
<1.0:1 <0.25
0.26 to 0.51
<0.52
1.1 to 4.9:1 <0.25
0.26 to 0.51
>0.52
>5.0:1 <0.25
0.26 to 0.51
>0.52
TOTAL
Office workers 0.06
4
7
8
9
32
15
7
2
13
97
4
2
3
4
7
20
11
2
1
11
61
0
50
43
50
78
63
73
29
50
85
63
0
                                          7-147

-------
                                     TABLE 7-29




                 Nasal Medical Findings in a Chromium-Plating Plant*
Case
1
2
3
H
5
6
7
8
9
Age, yr
30
19
19
18
47
45
23
20
48
Duration of
Exposure, mo
6
2
12
9
10
6
1
0.5
9
Findings
Perforated septum
Perforated septum
Perforated septum
Perforated septum
Ulcerated septum
Ulcerated septum
Ulcerated septum
Moderate injection of septum and turbinates
Moderate injection of septum
•Source:  NAS, 1974
                                           7-148

-------
0.004 mg/nr; however, it was not known if this was a reaction to chromium or to




the acidity of the aerosol.




     Vigliani  and  Zurlo  (1955)  reported  nasal  septal  perforation  in workers




exposed to chromic acid and  chromates  in concentrations of 0.11 to 0.15 mg/m  •




The  lengths  of exposure  were not  known.   Otolaryngologic  exeiminations  of 77




persons exposed to chromic acid  aerosol during  chrome  plating  revealed 19? to




have septal perforation and 48$ to have nasal mucosal irritation.  These people




averaged 6.6 years  of exposure to an air chromium  concentration of 0.4 mg/m  .  In




14 persons, papillomas of the oral cavity and larynx were found.  The diagnosis




of papilloma was confirmed by histologic examination.   There were  no signs of




atypical growth or malignant degeneration (Hanslian et al.,  1967).




     Cohen et al.  (1974) have  identified a serious health hazard among workers in




a nickel-chrome  plating area.   Thirty-five  of  37 (95/t)  employees  exposed to




atmospheric concentrations averaging 0.0071 mg/m  as  total chromium were shown




to have developed  significant nasal pathology  and skin lesions characteristic of




exposure to chromic acid.   The authors attributed the high incidence of adverse




health effects to the lack of emphasis on the implementation of good industrial




hygiene and personal  hygiene.  The mechanism postulated for  the occurrence of the




observed nasal damage resulted from either long-term exposure to levels of Cr(VI)




below prescribed "safe" levels, or direct contact of the affected tissue resul-



ting from inadequate personal hygiene practices.




     The literature suggests that chromium compounds are responsible for a wide




variety of  other  respiratory  effects.   Studies done by  German  investigators




demonstrate mixed results  from exposure  to  chromium  compounds.   Fischer (1911)




and  L^hmann  (1914)  reported  that  there  were no  marked clinical  symptoms in




persons exposed to  chromate dust.   Other German investigators (Alwens and Jonas,




1938; Fischer-Wasels,  1938;  Koelsch,  1938; Lehmann,  1932;  Mancuso,  1951)  have
                                     7-149

-------
reported that prolonged inhalation of chromate dust caused chronic irritation of



the respiratory  tract and  resulted  in such  manifestations as  congestion and



hyperemia,  chronic  rhinitis, congestion  of the  larynx, polyps  of the  upper



respiratory  tract,  chronic inflammation  of the lungs,  emphysema,  tracheitis,



chronic bronchitis, chronic pharyngitis,  and bronchopneumonia.   X-ray  findings



included enlargement of the hilar region (often on only one side), enlargement of



the lymph nodes, increase  in peribronchial  and  perivascular lung markings, and



adhesions of the diaphragm.  Letterer  et  al.   (1974)  and Lukanin (1930) stated



that a characteristic pneumonoconiosis  resulted  from exposure to some chromates.




correlation  between  workers  exposed  to  a  given  airborne  concentration  of



chromium (VI) and the development  of harmful effects  could not be made.



     Cohen and Kramkowski  (1973)  and  Cohen et  al.  (1974)  examined  37 workers



employed by  a chromium-plating plant.    Within  1  year  of  being employed,  12



workers experienced nasal  ulceration or perforation.  The airborne chromium (VI)



concentrations ranged from <0.71 to  9.12 pg/m .



     In a chromium plating  plant where the maximum airborne chromium (VI) concen-



tration was  3 pg/m  ,  no ulcerated nasal  mucosa or perforated nasal  septa were



found; however, half of the 32 employees had varying  degrees of mucosal irrita-



tion  (Markel and Lucas, 1973).  This was  not thought to be significant  by the



investigators, because the survey was carried out at the peak of the 1972 to 1973



influenza epidemic.  The length of employment for the workers was as follows:  >8



years, 15 workers; 4 to 8 years, 7 workers;  1 to 4 years, 4 workers;  <1 year, 6



workers.




     Machle and Gregorius  (1948) reported an incidence of nasal septal perfora-



tion  of  43.5$  in 354 employees who worked  in a chromate-producing  plant that



manufactured sodium chromate and bichromate.  At the time of the study, airborne



chromate concentrations ranged  from  10 to  2800 pg/m  .   The plant has been in
                                     7-150

-------
operation for at least 17 years, and  some  employees had probably worked in the



plant when reverberatory  furnaces,  a prominent source of high chromate exposure,



were used.



     Chromium exposure in  Australian shipyards,  resulting  from welding opera-



tions, has  been reported by  Bell  (1976) to  cause  irritation to the  nose and



throat at welding fume ranging  from 0.006  to 0.05 mg/  .  Lung biopsy specimens



from welders  confirmed  the presence  of severe pneumoconiosis  similar  to that



reported by Stettler et al. (1977).



     Various  other  disease  states  such  as asthma  have  been attributed  to



chromium, but,  in  most cases,  the etiologic  relation  to  chromium  is  obscure




because of the presence of  other chemicals  (WAS, 1974).  Asthma was reported as a



complaint among workers employed  for >10 years in a ferrochromium plant in Norway



(Broch, 1950).  Bronchial asthma was  also  reported  in Russian bauxite workers,



where Cr(VI)  was involved  in the  bauxite  caking  process  (Budanova,  1976).   A



clinical test for the diagnosis  of actual  or imminent bronchial allergic reac-




tions to Cr(VI) has been developed by Budanova and Makarova (1979).   A correla-



tion  was  established between  the  concentration  of  leukocyte  agglomerates  in



blood stimulated by Cr(VI), with 3% for a healthy control group versus =16$ for



workers with heavy  bronchial  asthma.  It appears,  then,  that chromium sensitiza-



tion can occur  after  inhalation exposure as  well as dermal exposure.   In one



chromium-alloy plant,  four cases of pulmonary disease with nodular fibrosis and



ventilatory impairment were reported by Princi et  al. (1962),  but no such cases



were found in another similar plant (Pierce and Scheel, 1965).



     Bovet  et al.  (1977)  have  suggested that  workers  exposed to  chromium  in



electroplating operations have increased frequencies of obstructive  respiratory




disease.  The lowest dynamic values of pulmonary function (e.g., vital capacity,



forced vital  capacity,  forced  expiratory  volume, and  forced  expiratory flow)
                                     7-151

-------
were  reported  for those workers displaying the higher urinary chromium  levels.



The  effect of  tobacco  smoke on  pulmonary function was minor  compared  to  the



effect  attributed to  chromium exposure.   Forced  expiratory flow  and  forced



expiratory volume  were  the pulmonary functions decreased to the greatest extent



as a  result of  occupational  exposure to  chromium.   The total number of workers



examined was 44, and no data on specific compounds, levels or duration of expo-



sure  were reported.




      Capodaglio  et al.  (1975)  demonstrated alterations in respiratory function



among bichromate and chromic acid production workers.   Observed changes in chest



X-ray and respiratory function parameters were hypothesized to be the result of



exposure  to  chromate,  and  the extent of  the  reduced pulmonary  function  was



correlated to length of exposure.  Data on the specific compounds and levels of



exposure were not  reported  in  the only available review of  this  study  (NIOSH,



1975).



      Workers in a chromite  mine  and  concentration plant developed pulmonary




markings  (ground-glass  types  1  and 2) that  were attributed  to  chromite dust.



However, free silica  dust was also present  in the air.  No clinical or roentgeno-



logic evidence of  fibrosis was  found in  the chromate workers (Federal Security



Agency, 1953).       Royle  (1975)   has  investigated  the  occurrence  of  various



respiratory symptoms among  British electroplaters  exposed to chromic acid.   A



total of  997 platers and 1117 controls  completed  a  Medical Questionnaire  on



Respiratory Symptoms. There was a significant  (p<0.025) occurrence of attacks of



bronchitis in platers  (28.2$)  compared to controls  (23.7$).  Platers also had



significantly higher incidences  of haemoptysis,  perennial nasal  catarrah,  and



Grade .2 habitual  winter cough  and Grade 2  winter phlegm  production.  Putative



asthma was indicated in  13.1$ of  the platers  at a 2.5$ level of  significance.



Nasal and skin ulcers were significantly higher  in  platers.   Smoking histories
                                     7-152

-------
were comparable in intensity  and  longevity for both  populations.   No clinical




testing or  medical  examinations were  performed  to verify  the  findings  of the




Medical Questionnaire.   Controls  were more frequently exposed  to  a variety of



"dusts" in  present or  previous employment  situations  or  both, and  were also




exposed to  asbestos much more so than  was the study population.   Air samples




taken between the years  of  1969 and 1970 were <0.03 mg/m   in all but two cases




(these were reported as <0.1 mg/m ).  Dust samples generally ranged from 0.3 to




97.0 mg/g, but were reported as high as 298 mg/g.   Members of both the study and




control populations were exposed to a variety  of additional  compounds that could




cause similar symptoms (asbestos,  cadmium,  nickel), a  circumstance that detracts




from the overall quality of the study as does the  use of medical questionnaires




without any medical examinations to substantiate these subjective findings.




     Lucas and Kramkowski (1975) have examined the occurrence of abnormal medi-



cal findings in a "hard" chromium  electroplating processing  plant.  A total of 11




workers were screened  for various  medical complaints associated  with exposure to




chromic acid  in  electroplating operations.   Average  age  of the workers  was 39




years (range 22 to 5^), with an average occupational exposure of  7.5 years (range




3  to  16  years).   Average  airborne  chromium  (VI)  levels  were   reported  as




O.OOM mg/m  , with a range of >0.001 to 0.020 mg/m  ,  well within acceptable limits




of the current NIOSH standards.  Ventilation systems appeared to be functioning




adequately, and work surfaces  adjacent to the  electroplating site were free from




contamination by chromium trioxide,  CrO_.  A summary of medical findings is found



in Table 7-30.   Despite the  degree of  protection offered by  ventilation  and




protective  clothing and equipment,  workers  displayed a  significant  number of




adverse medical effects at presumably "safe" levels of exposure.




     In addition,  a  fine  nodular  pneumoconiosis  has been reported  in  a  few




chromite miners in South Africa (Sluis-Cremer and duToit, 1968).  The available
                                     7-153

-------
                                    TABLE 7-30

                                                                            a
      Medical  Complaints of Workers in  "hard"  Chromium  Electroplating  Plant
   Frequency                                  Symptom
       1                              Nasal irritation

       4                              Nasal soreness 'c

       6                              Runny nose (chronic) '°

       4                              Frequent nose bleeds

       2                              Ulceration of nasal septum

       9                              Scars indicating previous
                                        Ulceration of the nasal septum

       4                              Perforated nasal septum

       5                              Chronic coughing episodes

       2                              Pulmonary distress indicative
                                        of emphysema

       7                              Current skin sores

       9                              Scars indicating healed chrome
                                        Ulceration on skin

       5                              Gastric distress

       1                              Chemical diabetes

       1                              Ocular pterygium on corneal
                                        conjunctiva

       1                              Advanced renal carcinoma (1967
                                        diagnosis; 1968, one kidney
                                        removed; 1973, metastasized
                                        to second kidney; 1974, cobalt
                                        treatment
Q  	 _         ._..__		L	 mT*m • 	n__M . _w - —  _ —  _. u_  T- IIM	- _m_ 	- -1-. -	 . _-  TI. 	 ._ -- -|  -.• _,	 ; _-
.Source:  Lucas and Kramkowski, 1975
 Previous to occurrence of nasal perforation.
 .Two occurences were attributed to cold outdoor temperatures.
 Three individuals were reported as moderate to heavy smokers.
                                         7-154

-------
evidence suggests that the pneumoconiosis is due to deposition of chromite dust




in the  lung tissue, and  that  the condition is benign  and  caused  no fibrosis.




Other components of the ore, such as iron,  may also  have  been responsible for the



observed fine nodular pneumoconiosis.








7.5.2.  Renal Effects Of Chromium.  Several authors have reported kidney damage




following  the  deliberate ingestion  or  therapeutic  application  of  chromium




compounds  (Brieger,  1920; Godlman and Karotkin, 1935;  Major  1922;  Partington,




1950; Rambousek,  1913).   Twelve  persons  died  after  the application  of  anti-




scabietic ointment  in which sulfur  had  been replaced  with Cr(VI).   Necrosis of




the skin developed  at sites of application and was followed  or  accompanied by




nausea,  vomiting,  shock, and  coma.   Urinalysis  revealed  albumin  and  blood.




Post-mortem  findings  included  tabular  necrosis and  hyperemia  of the  kidneys




(Brieger, 1920).




     Only one of the above studies (Goldman and Karotkin, 1935) was available for




review.  It is difficult to determine if  chromium  has a direct  toxic effect on




the kidneys or  alters the normal  homeostasis of the body, thereby exerting its




effect.  Evidence to support the first view comes from a study conduted by Mutti




et al.   (1979).    They  examined  welders  and chromium  platers,  and  found that




workers with a higher degree of exposure to chromium showed a pattern of nephro-



toxicity, as evidenced by increases  in the indices for renal  tubular damage.  The




length of  exposure and  concentration of  chromium  were  not  specified.    It  is




interesting  to  note that the  workers  who had  a higher degree  of exposure  to




chromium also demonstrated higher urinary chromium  values.




     Pederson and Mersch (1978) reported the incident  of a woman who ingested 10




mH of a 50-% chromic acid solution with 150 mJl of Coca-Cola.  Vomiting occurred




several times in the hospital,  where gastric lavage was  performed and activated
                                     7-155

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charcoal, magnesia, and  milk  were administered.   Hemodialysis was initiated  18



hours after ingestion.  Blood  samples were consistent with anemia, which was most



pronounced by  the eighth day of  hospitalization.   Slight granulocytopenia was



observed  on  the third day.   There was significant proteinuria  (1.9 g) on the



first day.




     Bilirubin levels rose during the first  3 days.  One day after ingestion, the



patient was admitted to the renal unit; the  serum chromium was 1.37 pg/m£ (2.94



mg Cr/A whole blood).  Dialysis treatment was instituted, which accelerated the



removal of  chromium from the  serum.  During the  patient's stay, no  signs of



gastrointestinal  or cerebral  disturbance  were  noted.   Hepatic  function  was



normal upon discharge, following a hospital  stay of 11 days.








7.5.3.   Miscellaneous Toxic  Effects.   Mancuso  (1951) reported  that  chromate



workers   frequently   showed   excessive  susceptibility   to   inflammatory  and



ulcerative  conditions  of  the gastrointestinal  tract  caused  by  ingestion  of



chromium.



     Hepatic injury, apparently due to exposure to chromic acid mist from plating



baths, has been reported  (Pascale et al.,  1952).   One woman who had been employed



for 5 years at a chromium plating factory was hospitalized with jaundice and was



found to be excreting significant amounts of chromium.  A liver biopsy specimen



showed microscopic  changes  resembling those found  in toxic hepatitis.   Eight



coworkers were screened for urinary chromium excretion in an effort to investi-



gate the possibility that the hepatic damage  was of occupational origin.  Four of



the workers were  found to be excreting significant amounts  of chromium.  In three



workers who  had been exposed to chromic acid mists for 1 to 4 years, liver biopsy



specimens and  a  series of  12  hepatic  function  tests  showed  mild to  moderate
                                     7-156

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abnormalities.  The correlation of degree of hepatic injury with the concentra-

tion of chromic acid mist and information on controls were not available.

     Frenkiel and Albert  (1976)  reported  that  traumatic injury of the tympanic

membrane  and  external auditory  canal,  and  changes  in middle  ear  mucosa were

suffered  by   a worker who had  fallen into a  vat  of chromic  acid.   Extensive

chemical  burns were sustained,  along  with a 20 decibel conductive hearing loss

stemming  from an acid burn to the right tympanic membrane.
7.6. SUMMARY OF TOXIC EFFECTS  OTHER  THAN CANCER FOLLOWING EXPOSURE TO CHROMIUM
COMPOUNDS
     Inhalation  is both  the most  predominant  route  of exposure  to chromium

compounds  in industry,  and  the  route  most  extensively investigated.   Local

effects  on the  respiratory  system are  the  primary toxic  effects  observed in

workers exposed  to chromium  in the  atmosphere.   Cr(VI),  in the form of chromic

acid, has been associated for many years with the development of perforations of

the nasal septum.  The implication of chromic  acid as  the  causative agent results

from the  common  occurrence of this disorder in  the chromium-plating industry,

where exposure is restricted  to this Cr(VI) compound.  Other  Cr(VI) compounds may

also participate in the etiology of perforated nasal septums, since this disorder

has been reported in the chromate manufacturing industry, where the predominate

exposures  are  to Cr(III) and the Cr(VI)  compounds,  sodium chromate and sodium

dichromate; however, chromic acid mist may also be present in these plants.  It

is interesting to note that nasal septum perforation has  not been reported as an

occupa'tional hazard in the chrome leather tanning industry or the chrome pigment

industry,  both of which exclusively use  Cr(VI), although  these  industries are

associated with severe chromium dermatitis.  The  lack of perforated nasal septums

in these industries may result from differences  in  the  physical or chemical form
                                     7-157

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                                               I
of the chromium, droplets in the tanning industry and particulates in the pigment
industry as compared to the chromic  acid mist generated in the plating industry.
The measurements  of chromic  acid  associated  with perforated  septums in  the
chrome-plating industry is >0.1 mg/m^ (see  Table 7-26); however, it is not known
if lower  concentrations  are also effective.   Also,  severe irritation of  the
throat and lower respiratory tract have been associated with chromium compounds
at concentrations  as low as  0.12 mg/m  .  Again, as with perforated nasal septum,
this respiratory  tract  irritation is primarily associated with  Cr(VI).   Hyper
sensitivity may result from dermal  or inhalation exposure to either  Cr(VI)  or
Cr(III); however,  there is little information available on the levels of exposure
necessary to induce an allergic response.
     Little  information is  available  on   systemic  effects  of inhalation  of
chromium  compounds,  although  Pascale  et  al.   (1952)  and  Mutti et al.  (1979)
reported liver injury in a chromate  worker  and  kidney injury in a welder exposed
to chromium, respectively.  Acute exposure of animals using a variety of routes
of administration  (Section  7.1.2)  have indicated that both Cr(VI)  and Cr(III)
compounds can produce kidney and liver  damage,  although the dose levels employed
were relatively high.  From the evidence available from both human case reports
and animals studies, it can  only be  speculated whether the kidneys and liver may
be target organs following chronic exposure to chromium compounds.
     Although inhalation studies  of occupational  exposure  to  chromium indicate
that exposure to some chromium compounds can result in perforation of the nasal
septum, irritation of the respiratory tract, pneumoconiosis, bronchitis, chronic
lung congestion,  and possible liver and kidney damage  (as supported by target
organ toxicity in  acute animal studies), there  are  insufficient data available to
make a quantitative risk assessment for either chromium as  a class or individual
chromium compounds from these inhalation studies.  The only studies that provide
                                     7-158

-------
any exposure data are the studies  of the occurrence of perforated nasal septums.




However, these are of limited and questionable quality, since measurements were




not made contemporary with exposure and personal habits, such as picking of the



nose, may  result in high  local  concentrations of chromium.   Since perforated




nasal septum results from  the  local  destruction of the mucous  membrane  of the




nose, this does not represent a systemic effect of chromium.  Also, in the study




by Nettesheim et  al.  (1971), inhalation exposure of mice to chromium resulted in




marked effects to the respiratory tract.   These effects,  including hyperplasia




and necrosis, were likely  to have resulted  from the  severe  local irritation of




the  cells  lining the  air ways.   It  would not  be  expected that  exposure  to




chromium by any  other route  would result in this disorder,  and although these




data can  be  used to derive  an acceptable  inhalation exposure  level,  they are




inadequate for determining safe levels of chromium by all routes  of exposure.




The limited information on other systemic effects of inhaling  chromium, liver and




kidney damage, contains  both  insufficient  exposure data and too few case reports




to form a firm association between exposure and effect.




     There are only  a few instances of  human exposure to overtly toxic levels of




chromium compounds by ingestion,  and these  represent  acute exposure to massive




doses which provide little information on the safe levels  of chromium following




chronic exposure.  A number  of animal  studies  have  been performed  in which the




chromium compound was administered in the food, water, or  by  gavage.  The acute




oral toxicity data indicate that Cr(VI) is approximately 2 or 3 orders of magni-




tude more toxic  than Cr(III), with the latter  toxic  at  the level  of  g/kg body




weight (Section  7.1.2).   The difference in valence state may  be less relevant




following chronic or subchronic ingestion of chromium,  since it is suggested that




Cr(VI)  is  reduced  to Cr(III) under  the acid  conditions  of  the stomach.   The




determination as  to  whether Cr(III) or Cr(VI)  is more toxic  after chronic expo-
                                     7-159

-------
sure, however, cannot be made,  since none of the studies employed a sufficiently



high dose to produce a toxic effect.




     The  only ingestion  study in  which an  effect was  observed  was  that of



Ivankovic and Preussman (1975) in which  rats  were  fed  diets containing 2 or 5%




Cr^Q (Cr+ ), 5 days/week for 90 days.  The only observed effect was a reduction



in the weight of the liver and spleen in the treated male rats as compared with



liver and spleen weights  of  control animals.   Similar results were observed in



female rats maintained on  the  same  diet.  Neither  organ  showed  macroscopic or



microscopic abnor malities, and the  authors concluded that these changes were not



toxicologically important. In  a larger 2-year study using the same experimental



procedure and 60 animals  of  each  sex per group,  Ivankovic and Preussman (1975)



did not mention any treatment-related changes in organ weight, although it was



mentioned that  no  signs of  chronic toxicity  were observed.   Therefore,  it is



unclear whether the slight change in organ weight observed in the small number of



animals in  the  90-day  study  was the result of spurious  observation  due to the




small group size, or whether  the 5% exposure level represents a true NOAEL (no-



observed-adverse-effect-level).  No matter whether this 90-day study represents



a NOAEL or an NOEL (no-observed-effect-level), the  small  group size  makes this



study very tenuous as the basis for quantitative  risk assessment.



     While chromium compounds have been shown  to cause developmental toxicity in



experimental animals, the  reproductive effects (e.g.,  fetal malformation)  were



observed only  where maternal toxicity was  also  present.  Because of the unnatural




routes  of exposure  in  these  studies (e.g.,  intravenous and  intraperitoneal



injection),  the  relevance  of  these developmental  effects  to  environmental



exposures is very uncertain;  more research is  indicated to better understand the



implications of different levels  and routes  of exposure.
                                     7-160

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     In the absence of any data  on  effect  levels following chronic exposure to




chromium, the  U.S.  EPA,  in  the  Ambient  Water  Quality  Criteria Document  for




Chromium  (U.S.  EPA,  1980a),  derived acceptable  daily intake values  (ADIs)  of




0.175 and 125 mg/day/man for Cr(VI)  and Cr(III),  respectively.  These ADIs were




derived by using the highest NOEL available for each valence state.  For Cr(VI),




the study of MacKenzie et al.   (1958)  was  used,  in which  rats  were  exposed to




several  levels  of  chromium  in the  form of K CrOj.  up  to  25 ppm  in the drinking




water for 1 year, while for Cr(III),  the chronic study  of Ivankovic and Preussman




(1975) was used,  in which rats were fed diets containing  up  to 5%  C^O, for 2




years.   The  ADIs for both  Cr(VI)  and  Cr(III) were  expressed  as mg/d  of  the




compound administered.  Although these  ADIs were derived, it is not apparent from




the toxicologic information available whether the ADIs are more appropriate for




the specific chromium compounds tested, K Cr(V and Cr-O-,  rather  than the general




classes of Cr(VI) and Cr(III).   This is particularly hard to determine, since no



toxic effects were observed in these chronic animals  studies.
                                     7-161

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-------
                     8.  CURRENT REGULATIONS AND STANDARDS




     A number of recommended standards  presently  exist  for permissible levels of




chromium in both air and water.  The National Academy of Science (NAS, 1980) and




the U.S. Environmental Protection Agency (U.S.  EPA,  1980a),  in regard to ambient




water quality criteria, have stated that  a  distinction between the Cr(III) and




(VI) forms  should  be made when considering  the  formulation of regulations and




exposure criteria.








8.1.  OCCUPATIONAL EXPOSURE




     NIOSH  (1973, 1975), OSHA (1978), and ACGIH  (1981) have recommended various




exposure limits for chromium.  These values are based on the  chemical form of the




chromium compounds or their solubilities.  Table  8-1  outlines the various United




States occupational standards for chromium compounds.








8.2.  EXPOSURE TO CHROMIUM IN AMBIENT WATER.




     A number of standards  exist for chromium in ambient water or drinking water.




In general, the standards for occupational exposure to chromium in  the air allow




for a greater  uptake of  chromium than  by the  uptake  of chromium from drinking




water.   The U.S.  EPA (1980a) has  estimated the daily intake of chromium from



drinking water to be 5 pg/day.  Table 8-2 outlines various  recommended or esta-




blished standards for chromium in the United States.




     The U.S.  EPA  (1980a)  recently  proposed several ambient water quality cri-




teria  for  chromium.   Based on  methodology outlined  in  the  Federal Register




(45 FR 79353),  acceptable  daily  intakes  (ADIs),  no-observable-adverse-effect




levels  (NOAELs), and bioconcentration  factors  (BCFs) obtained  from experimental




animal  studies,  separate  water  quality criteria  were  proposed.   Table 8-3
                                      8-1

-------
                                      TABLE 8-1

           Recommended Occupational Standards and Recommended Criteria for
                       Chromium Compounds in the United States
Chemical Form
Non-carcinogenic chromium (VI)a
Carcinogenic chromium (VI)C
Chromic acid (as chromium trioxide)
Soluble chromic or chromous salt
Insoluble salts or chromium metal
Chromium metal
Chromium (II) compounds
Chromium (III) compounds
Chromium (VI) compounds
water soluble
water insoluble
r>
Chromite ore
Chromium: soluble chromic and
chromous salts
Standard (pg/m^)
25 TWAb
50 Maximum
1
50 TWA
100 Maximum
500 TWA
1000
500 TWA
500 TWA
500 TWA
50 TWA
50 TWA
50
500 TWA
Reference
NIOSH, 1975
NIOSH, 1975
NIOSH, 1973
OSHA, 1978
OSHA, 1978
ACGIH, 198ld
ACGIH, 1981
ACGIH, 1981
ACGIH, 1981
ACGIH, 1981
ACGIH, 1981
ACGIH, 1981
 NIOSH listed  "non-carcinogenic"  chromium VI compounds as the monochromates and
 dichromates (bichromates)  of:  hydrogen, lithium,  potassium, rubidium, cesium,
 ammonium,  and chromic oxide (chromic acid anhydride).

DTime  Weighted Average

'NIOSH listed  "carcinogenic" chromium VI  compounds  as all other chromium compounds not
 included  in the "non-carcinogenic"  chromium VI  listed above.

 These'are also known as  the TLV  values established by ACGIH.
a
'ACGIH listed  these classes of  chromium compounds as substances associated with
 industrial use that have been  recognized as carcinogens.
                                       8-2

-------
                                      TABLE 8-2

                         Recommended Standards for Chromium
                       In Ambient Waters in the United States
Chemical Form
Chromium (VI)
Total Chromium
Total Chromium
Chromium (VI)
Medium
drinking water
total
domestic water
supply
freshwater
(aquatic life)
livestock water
Criteria (ng/£)
50
50
100
1000
Reference

U.S. Public Health
Service (USPHS), 1962
U.S. EPA, 1976
U.S. EPA, 1976
National Academy


of
Chromium
community water
systems and non-
community water
systems
50
                                                                Science  and National
                                                                Academy  of Engineering
                                                                (NAS/NAE),  1972
40 CFR
                                          8-3

-------
                                                     TABLE 8-3

                                        Ambient Water Quality Criteria  for
                                          the Protection of Hunan Health3




00
1

Chemical
Form
Chromium (III)b

Chromium (VI)

NOAEL
(rag/ JO
50,000

25
Rat
NOAEL
(mg/d/kg)
1786

2.50
ADI
for man
(mg/d/man)
125

0.175


BCF
16

16

Calculated
Criteria (ng/fc)
59,000

83
	 1
 Source:  U.S. EPA, 1980a

 Revised ADI and criterion.  Published values (45 FR 79331) were incorrect.  If exposure to trivalent chromium
results  only from the eating of fish and shellfish, then the calculated ambient water criterion for chromium
(III) is proposed  as 1200 mg/i, (1.2 x 10 jig/i)

-------
summarizes the proposed U.S. EPA (1980a) ambient water quality criteria for the




protection of human health.



     The U.S. EPA (1980a) also has  proposed  several  ambient water quality cri-




teria for the  protection of aquatic  life.   Table 8-4 summarizes  the proposed




criteria for the protection of aquatic life.








8.3. EXPOSURE TO CHROMIUM IN AMBIENT AIR.




     No federal or  state (other than the state  of Maine,  i.e.,  0.05 pg/nr for




mean annual and 0.3 pg/m  for mean daily limits) ambient air chromium standards




have been proposed.  No United  States emission  standards for chromium were found




in the available literature.  The U.S.S.R. recommends  a "sanitary clearance zone"




of  1000 m for  plants  discharging 200 kg Cr(VI)  per  day,  and  2000 m for plants




discharging 1000 kg per day (NAS, 1974).
                                      8-5

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                                    TABLE 8-4

                    Calculated Ambient Water Quality Criteria
                       for the Protection of Aquatic Life*
Chemical
Form
Chromium (VI)
Chromium (III)
Freshwater
24 -hour Average
(ng/a)
0.29
44
(chronic value
toxicity)
Life
Maximum
(us/ JO
21
NR
Marine Life
24-hour Average
(jig/A)
18
10,300 (acute
toxicity value)
Maximum
(ng/n)
1260
NR
•Source:  U.S. EPA, 1980a
NR = Not recorded
                                        8-6

-------
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