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  EP A/600/AP-92/OOU
          August 1992
Workshop Review Draft
                      Chapter 4.  Immunotoxic Effects
                                  Health Assessment for
                        2,3,7,8-TetrachIorodibenzo-p-dioxin (TCDD)
                                 and Related Compounds
                                         NOTICE

  THIS DOCUMENT IS A PRELIMINARY DRAFT.  It has not been formally released by the U.S.
  Environmental Protection Agency and should not at this stage be construed to represent Agency
  policy.  It is being circulated for comment on its technical accuracy and policy implications.
                         Office of Health and Environmental Assessment
                              Office of Research and Development
                             U.S. Environmental Protection Agency
                                      Washington, D.C.
                                                                    Printed on Recycled Paper

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                                       DISCLAIMER


       This document is a draft for review purposes only and does not constitute Agency policy.

Mention of trade names or commercial products does not constitute endorsement or recommendation

for use.
           Please note that this chapter is a preliminary draft and as such represents work
           in progress.  The chapter is intended to be the basis for review and discussion at
           a peer-review workshop. It will be revised subsequent to the workshop as
           suueestions and contributions from the scientific community are incorporated.
                                                n
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                                 CONTENTS






Tables 	 iv




Figures	•	v




List of Abbreviations	vi




Authors and Contributors	 xi




4.  IMMUNOTOXICITY	 4-1




   4.1.   INTRODUCTION  	 4-1




   4.2.   ROLE OF THE AH LOCUS IN HAH IMMUNOTOXICITY 	 4-3




   4.3.   TOXIC EQUIVALENCY FACTORS (TEFs) FOR IMMUNOTOXICITY	  4-11




   4.4.   INTERACTIONS BETWEEN HAH	  4-14




   4.5.   SENSITIVE TARGETS FOR HAH IMMUNOTOXICITY	  4-14




   4.6.   INFLUENCE OF TCDD ON HOST RESISTANCE TO DISEASE	  4-20




   4.7.   IN VITRO IMMUNOTOXIC EFFECTS OF HAH  	  4-23




   4.8.   INDIRECT MECHANISMS OF  HAH IMMUNOTOXICITY  	  4-25




   4.9.   ROLE OF THE THYMUS IN HAH IMMUNOTOXICITY	  4-26




   4.10.  IMMUNOTOXICITY FOLLOWING PRE/NEONATAL EXPOSURE TO HAH	  4-27




   4.11.  IMMUNOTOXICITY OF HAH IN NON-HUMAN PRIMATES	  4-30




   4.12.  IMMUNOTOXICITY OF HAH IN HUMANS 	  4-33




   4.13.  REFERENCES 	•	  4-37
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                                   LIST OF TABLES
4-1    TEFs Based on the IDX for Suppression of the PFC Response
      to SRBC in Ah Responsive B6 Mice  	
4-2    TEFs Based on the IDjo for Suppression of Alloantigen-
       Specific CTL Response in Ah Responsive B6 Mice . . .
4-3    Effect of Single Versus Multiple Dosing with TCDD on
       Suppression of the Antibody Response to SRBC in
       C57B1/6 Mice  	•	
 4-4    Influence of Route of Antigen Challenge on Suppression of
       the Antibody Response to SRBC in C57B1/6 Mice	
 4-5    Immunotoxic Effects of TCDD in the Offspring Following
       Pre/Neonatal Exposure to TCDD	
 4-7
4-10
4-12
4-13
 4-28
                                             IV
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                               LIST OF FIGURES
4-1    Structure Dependent Immunotoxicity of Some CDD and CDF
      Isomers	
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ACTH




Ah




AHH




ALT




AST




BDD




BDF




BCF




BGG




bw




cAMP




 CDD




 cDNA




 CDF




 CNS




 CTL




 DCDD




 DI1T




 DMBA




 DMSO




 DNA




 DRE
             LIST OF ABBREVIATIONS






Adrenocorticotrophic hormone




Aryl hydrocarbon



Aryl hydrocarbon hydroxylase




L-alanine aminotransferase




L-asparate aminotransferase




Brominated dibenzo-p-dioxin




 Brominated dibenzofuran




 Bioconcentration factor




 Bovine gamma globulin




 Body weight



 Cyclic  3,5-adenosine monophosphate




 Chlorinated dibenzo-p-dioxin




• Complementary DNA



 Chlorinated dibenzofuran




 Central nervous system




 Cytotoxic T lymphocyte



 2,7-Dichlorodibenzo-p-dioxin




  5a-Dihydrotestosterone




  Dimelhylbenzanthracene




  Dimethyl sulfoxide



  Deoxyribonucleic acid




  Dioxin-responsive enhancers
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                            LIST OF ABBREVIATIONS (cont.)
DTG




DTH
ECOD




EGF




EGFR




ER




EROD




EOF




FSH




GC-ECD




GC/MS




GOT




GnRH




GST




HVH




HAH




HCDD




HDL




 HxCB




 HpCDD
Delayed type hypersensitivity




Delayed-type hypersensitivity




Dose effective for 50% of recipients



7-Ethoxycoumarin-O-deethylase




Epidermal growth factor




Epidermal growth factor receptor




Estrogen receptor




7-Ethoxyresuroftn 0-deethylase




Enzyme altered foci




Follicle-stimulating hormone




Gas chromatograph-electron capture detection




Gas chromatograph/mass spectrometer



Gamma glutamyl transpeptidase




Gonadotropin-releasing hormone




Glutathione-S-transferase




Graft versus host




Halogenated aromatic hydrocarbons




Hexachlorodibenzo-p-dioxin




High density lipoprotein




Hexachlorobiphenyl



 Heptachlorinated dibenzo-p-dioxin
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                            LIST OF ABBREVIATIONS (cont.)
HpCDF




HPLC




HRGC/HRMS




HxCDD




HxCDF




IDso



I-TEF
 LH




 LDL




 LPL




 LOAEL




 LOEL




 MCDF




 MFO




 mRNA




 MNNG




 NADP




  NADPH




  NK




  NOAEL
Heptachlorinated dibenzofuran



High performance liquid chromatography



High resolution gas chromatography/high resolution mass spectrometry




Hexachlorinated dibenzo-p-dioxin




Hexachlorinated dibenzofuran








International TCDD-toxic-equivalency




Dose lethal to 50% of recipients (and all other subscripter dose levels)




Luteinizing hormone



 Low density liproprotein




 Lipoprotein lipase activity



 Lowest-observable-adverse-effect level




 Lowest-observed-effect level



 6-Methyl-l ,3,8-trichlorodibenzofuran




 Mixed function oxidase




 Messenger RNA



 W-methyl-Af-nitrosoguanidine




 Nicotinamide adenine dinucleotide phosphate



  Nicotinamide adenine dinucleotide phosphate (reduced form)




  Natural killer



  No-observable-adverse-effect level
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                            LIST OF ABBREVIATIONS (cont.)
NOEL




OCDD




OCDF




PAH




PB-Pk




PCB




OVX




PEL




PCQ




PeCDD




PeCDF




PEPCK




 PGT




 PHA




 PWM




 ppm




 ppq



 ppt




 RNA




 SAR




 SCOT
No-observed-effect level



Octachlorodibenzo-p-dioxin




Octachlorodibenzofuran




Polyaromatic hydrocarbon




Physiologically based pharmacokinetic




Polychlorinated biphenyl




Ovariectomized




Peripheral blood lymphocytes




Quaterphenyl




Pentachlorinated dibenzo-p-dioxin



Pentachlorinated dibenzo-p-dioxin




Phosphopenol pyruvate carboxykinase




 Placental glutathione transferase




 Phytohemagglutinin




 Pokeweed mitogen




 Parts per million








 Parts per trillion



 Ribonucleic acid




 Structure-activity relationships



 Serum glutamic oxaloacetic transaminase
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                           LIST OF ABBREVIATIONS (cont.)
SGPT




SRBC




«»



TCAOB




TCB




TCDD




TEF




.TGF




 tPA




 TNF




 TNP-LPS




 TSH




 TTR




  UDPGT




  URO-D




  VLDL




  v/v




  w/w
Serum glutamic pyruvic transaminase




Sheep erythrocytes (red blood cells)




Half-time



Tetrachloroazoxybenzene




Tetrachlorobiphenyl



Tetrachlorodibenzo-p-dioxin




Toxic equivalency factors




Thyroid growth factor



Tissue plasminogen activator




Tumor necrosis factor



 lipopolysaccharide



 Thyroid stimulating hormone




 Transthyretrin



 UDP-glucuronosyltransferases




 Uroporphyrinogen decarboxylase




 Very low density lipoprotein




 Volume per volume




 Weight by weight
                                                                                  08/06/92

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                            AUTHORS AND CONTRIBUTORS

       The Office of Health and Environmental Assessment (OHEA) within the Office of Research
and Development was responsible for the preparation of this chapter.  The chapter was prepared
through Syracuse Research Corporation under EPA Contract No. 68-CO-0043, Task 20, with Carol
Haynes, Environmental Criteria and Assessment Office in Cincinnati, OH, serving as Project Officer.
       During the preparation of this chapter, EPA staff scientists provided reviews of the drafts as
well as coordinating internal and external reviews.

AUTHORS
Nancy Kerkvliet
College of Veterinary Medicine
Oregon State University
Coryallis, OR

EPA CHAPTER MANAGER
Gary R. Burleson
Health and Environmental Research Laboratory
Research Triangle Park, NC
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                              4.  IMMUNOTOXICITY

4.1.   INTRODUCTION
     Concern over the potential  toxic effects of chemicals on the immune system
arises from the critical role that the immune system plays in maintaining health.
It  is  well recognized  that suppressed  immunological  function can  result  in
increased incidence and severity of infectious diseases as well as some types of
cancer.   Conversely,  the inappropriate enhancement of  immune function or the
generation  of misdirected  immune responses can precipitate  or exacerbate the
development of allergic and autoimmune diseases.  Thus,  suppression as well as
enhancement of immune function are considered to represent potential immunotoxic
effects of  chemicals.
     The  immune  system  consists of  a complex network of  cells  and soluble
mediators that interact in a highly regulated manner to generate immune responses
of  appropriate magnitude and  duration.   Consequently,  comprehensive  evaluation
of  immunotoxicity  must  include  specific assessments  of multiple  functional
parameters  on a kinetic basis.  In addition, because an immune response develops
in  a time-dependent manner  relative  to antigen exposure, the immunotoxicity of
a chemical can  be profoundly  influenced by the  timing of  chemical  exposure
relative  to antigen  challenge.  Consideration of  these levels of  complexity
 involved  in immunotoxicology assessment are critical  for interpretation  of  the
effects of chemical exposure on immune function.
      Extensive evidence has accumulated  over  the past 20 years to demonstrate
 that the  immune  system is a target for toxicity of TCDD and structurally related
 HAH,  including the CDFs, PCBs and PBBs.  This evidence  has derived from numerous
 studies  in various animal species,  primarily rodents, but  also  guinea pigs,
 rabbits,  monkeys, marmosets and  cattle.   Epidemiological studies  also provide
 evidence for the immunotoxicity of HAH in humans.  In animals, relatively high
 doses  of HAH produce  lymphoid tissue depletion,  except in  the  thymus where
 cellular  depletion occurs  at  lower  doses.    Alterations  in  specific  immune
 effector functions and increased susceptibility to  infectious disease have been
 identified  at  doses  of TCDD  well  below those which  cause  lymphoid  tissue
 depletion.   Both  cell-mediated and  humoral  immune  responses are suppressed
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following TCDD exposure, suggesting there are multiple cellular targets within
the immune system  that  are altered by TCDD.  Evidence  also suggests that the
immune  system  is indirectly targeted  by TCDD-induced  changes  in nonlymphoid
tissues.  In addition, in parallel with increased understanding of the cellular
and molecular mechanisms involved in immunity, studies on TCDD are beginning to
establish biochemical and molecular  mechanisms  of  TCDD immunotoxicity.  These
advances will be highlighted in this document.
     There  is  an  enormous  literature  based  on  descriptive  studies  on the
immunotoxic  effects  of  TCDD and  related HAH  in  laboratory animals.  Unfortu-
nately,  due  to widely differing experimental designs,  exposure protocols, and
immunologic  assays used,  it has been very difficult to define a  "TCDD-induced
immunotoxic  syndrome"  in a single  species,  let  alone across  species.   For
example,  there is  only one report that directly compared the effects of TCDD  on
the immune system of rats,  mice, and guinea pigs,  and,  even then,  different
 immunologic  parameters  were assessed and  different  antigens were used  in the
different species (Vos  et al.,  1973).    In  that  study,  the  DTH response  to
 tuberculin was evaluated  in guinea pigs and rats for assessment of cell-mediated
 immunity, while the  GVH response was measured in mice.   A decreased DTH response
 to tuberculin was observed in guinea pigs following 8 weekly doses of 40 ng/kg
 TCDD (total dose,  320 ng/kg),  while the  DTH response of rats to tuberculin was
 unaffected by  6 weekly doses of  5 pg/kg TCDD  (total  dose, 30,000 ng/kg TCDD).
 The GVH response in  mice  was suppressed  by 4 weekly doses of 5 ^9/kg TCDD (total
 dose, 20,000 ng/kg  TCDD).  The  greater  sensitivity  of  guinea pigs compared to
 rats and mice  to  the immunosuppressive  effects of TCDD is consistent with the
 greater sensitivity  of guinea pigs to other toxic  effects  of TCDD  (McConnell et
 al., 1978; Poland and Knutson,  1982). Although these results appear to suggest
 that cell-mediated  immunity in mice  is  more sensitive  to  TCDD than in rats, no
 studies  have  directly  compared  rats   and mice  using  the same  antigens   and
 endpoints.    In another  study  in  mice,   the  DTH  response to  oxazolone   was
 suppressed  by 4 weekly doses of  4 pg/Kg TCDD (total  dose,  16,000  ng/kg), while
 the  DTH response  to SRBC was unaffected by a 10-fold higher dose of TCDD  (Clark
 et al., 1981), illustrating that DTH responses  to different antigens are  not
 equally sensitive to TCDD-induced suppression, even  in the same species.  When
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PCB and PBB  studies  are considered,  variable effects on  DTH  and other immune



reactions are also apparent (Fraker,  1980; Vos and Van Driel-Grootenhuis, 1972;



Luster et al., 1980a; Thomas and Hinsdill, 1978).  Because the exact basis for



the inter-study variability  is  not known,  it would serve no useful purpose in



terms of risk assessment to catalogue all of the effects of TCDD and other HAH



on the immune system that have been reported.  Several comprehensive reviews have



been published on the  immunotoxic effects of HAH in general (Kerkvliet,  1984; Vos



and Luster,  1989), and TCDD  in particular (Holsapple et  al.,  1991a,b).   The



reader  is also  referred  to the  previous EPA TCDD-Risk assessment document,



Appendix  E  (Sonawane  et  al.,   1988)  for another perspective  on TCDD  immuno-



toxicity.  The present document will not reiterate this extensive literature, but



rather,  will emphasize more  recent  developments in the  field of HAH  immuno-



toxicity  that may assist in the risk assessment process.   Gaps in our  knowledge




that  require further  research will also  be identified.



4.2.    ROLE  OF THE AH LOCUS  IN  HAH IMMUNOTOXICITY



      One  of  the most  important  advances  in the  study of  HAH toxicity  in recent



years has been the elucidation of  a genetic basis for sensitivity to the toxicity



of these  chemicals, which  may ultimately provide a logical explanation for much



of the  controversial  data  in the  literature regarding HAH toxicity in different



 species and in different tissues of  the same species.   In this regard, many of



 the biochemical and toxic  effects of HAH appear to  be mediated via binding to an



 intracellular protein known as  the Ah or TCDD receptor, in a process similar to



 steroid hormone receptor-mediated responses (Poland and Knutson, 1982; Cuthill



 et al.,  1988).   Ah receptor activation  follows  stereospecific ligand binding;



 interaction of the receptor-ligand complex with DREs in the genome induces the



 transcription of the structural genes encoding mRNA for CYP1A1 enzyme activity



 (i.e., cytochrome Pj450),  as well as the expression of additional unidentified




 genes, the products of which are hypothesized to mediate  HAH toxicity  (Whitlock,



 1990).   Differences  in toxic  potency between various  HAH congeners generally



 correlate with differences in Ah receptor binding affinities.  The most toxic HAH



 congeners  are  approximate  stereoisomers  of  2,3,7,8-TCDD  and  are  halogen-
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substituted in at least three of the four lateral positions in the aromatic ring
system.
     in mice, allelic variation at the  Ah locus has been described (Poland et
al., 1987; Poland and Glover, 1990).  The different alleles code for Ah receptors
that differ in their ability to bind TCDD,  and thus help to explain the different
sensitivities of  various  inbred mouse strains to  TCDD toxicity.  Ahbb C57B1/6
 (B6) mice represent the prototype  "responsive" strain and are the most sensitive
to  TCDD toxicity, while  Ahdd DBA/2  
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dioxin and furan isomers that contaminate technical grade pentachlorophenol.  The
1,2,3,6,7,8-HxCDD, 1,2,3,4,6,7,8-HpCDD and  1,2,3,4,6,7,8-HpCDF isomers, which
bind the receptor, were all significantly immunosuppressive.  The dose of each
isomer that produced 50% suppression  of the antiSRBC response (1050) was  7.1, 85
and 208 pg/kg for HxCDD, HpCDD and HpCDF, respectively  (Figure  4-1).  The  ID50
for TCDD was 0.65 pg/kg based on the  data of Vecchi et al.  (1980).  In contrast,
OCDD, which does not bind the receptor, was not immunosuppressive at a  dose as
high as 500 ^g/kg (Kerkvliet et al.,  1985).  More extensive  structure-dependent
immunosuppressive activities of  technical grade PCB mixtures (Davis and Safe,
1990), PCB congeners (Davis and Safe, 1989), and CDF congeners  (Davis and Safe,
1988)  have also been reported.  Results  of these studies using different HAH
congeners  are summarized in  Table 4-1.
     The  role  of the Ah receptor in suppression  of the antiSRBC response has
recently  been  verified in  studies  using  B6  mice  congenic at the  Ah  locus
 (Kerkvliet et al., 1990a).  As expected, congenic Ahdd-B6 mice were significantly
 less sensitive  to TCDD-induced immune suppression compared to wild-type Ah -B6
mice.  Unexpectedly, however, the dose-response in congenic B6-Ahdd mice appeared
to be  bimodal,  with a portion of the response sensitive  to suppression by low
 doses  of  TCDD.   Because  of the  bimodal  response,  the data  did not permit
 extrapolation of an ID50 dose in the  congenic mice.   The results were interpreted
 to suggest potential  non-Ah receptor mediated immunosuppressive effects.   It
 should be  noted,  however,  that recent  studies  by Dr.  Jay  Silkworth  using
 re-derived congenic Ahdd-B6 mice have thus  far not corroborated a bimodal  dose-
 response  (Silkworth,  personal  communication).    The  issue  of  Ah  receptor-
 independent immunotoxicity will be  discussed in detail in a subsequent section
 of this document.
      Ah receptor dependency of  HAH immunotoxicity has also  been demonstrated in
 mice using other immunologic responses.  For example, Kerkvliet et al. (1990a)
 reported that the  ID50 for  suppression of  the  antibody response to TNP-LPS in
 Ahbb B6 mice was 7.0 pg/kg compared to a significantly higher  ID50 of  30 pg/kg
 in congenic Ahdd B6 mice.   Since the antibody response to TNP-LPS  shows little
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              .Anti-SRBC response  (% of control)
         100  --
          80  --
          60
          40
          20
            0
                          ID,
                           BO
• TCDD
O HxCDD
A HpCDD
A HpCDF
• OCDD
0.65
 7.1
  85
 208
>500
             0.1
  i i 11 in|	1—i  t i i tu|	1—i i  i i ni|	1—i i i i ii
        10
 Dose  (/zg/kg)
                             100
                                FIGURE 4-1

      Structure Dependent Immunotoxicity of Some  CDD and CDF Isomers.
           Immunotoxicity Assessed by Suppression of the Splenic
                         Antibody Response to SRBC

                      Source:  Kerkvliet  et al., 1985
DIOXINS.HEALTH ASSESSMENT
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TABLE 4-1
TEFs for CDDs, CDFs and PCBs on the Acute Single Dose ID50 fof Suppression of the RFC Response to SRBC
in Ah Responsive B6 Mice
Congener
2,3,7,8-TCDD
2,3,7,8-TCDD
2.3.7,8-TCDD
2,3,7,8-TCDD
1,2,3,6,7,8-HxCDD
1.2,3,4.6,7,8-HpCDD
OCOD
2,3,4,7,8-TCDF
2,3,7,8-TCDF
1,2.3,4,6,7.8-HpCDF
1,2,3, 7,9-PeCDF
1,3,6,8-TCDF
3.4,3',4'-TCB
2,3,4,5,3',4'-HxCB
2.3,4,5,3',4'-HxCB
2,4,3',4',5',6'-HxCB
2,3,4,3',5'-PeCB
2,3,4,5,3',5'-HxCB
2,4,2',4'-TCB
2.4,5,2',4'.6'-HxCB
2,4,6,2',4',6'-HxCB
2,4,5,2'4',5'-HxCB
1D60
0.74 fig/ kg
0.65 fig/kg
0.77 fig/kg
0.60 fig/kg
7.1 tig/kg
85.0 fig/ kg
>500 /ig/kg
1.0 itg/kg
4.3 >ig/kg
208 ng/kg
239 /19/kg
11 /ig/kg
28 mg/kgb
0.7 mg/kg
36 mg/kgb
43 mg/kg
65 mg/kg
72 mg/kg
>100 mg/kg
>360 mg/kg
>360 mg/kg
>360 mg/kg
TEF
1.0a
1.0a
1.0a
1.0a
0.1
8.2x10'3
>1.4x10'3
0.7
1.6X10"1
3.4x10"3
2.9x10"3
6.4x10"5
2.5x10'6
1.0x10"3
1.9x10'5
1.6x10"5
1.1x10"5
9.7x10"6
>7.0x10"6
>1.9x10"6
>1.9x10'6
>1.9x10"6
Reference
Kerkvliet and Brauner, 1990
Vecci et a I., 1980
Davis and Safe, 1988
Kerkvliet et al., 1990a
Kerkvliet et al., 1990s
Kerkvliet et al., 1985
Kerkvliet et al., 1985
Davis and Safe, 1988
Davis and Safe, 1988
Kerkvliet et al., 1985
Davis and Safe, 1988
Davis and Safe, 1988
Silkuorth and Grabstein,
1982
Davis and Safe, 1990
Silkuorth et al., 1984
Davis and Safe, 1990
Davis and Safe, 1990
Davis and Safe, 1990
Silkworth et al., 1984
Davis and Safe, 1990
Davis and Safe, 1990
Biegel et al., 1989
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Aroetor 1248
• Nil • ••      ""
Aroclor 1242
"Based on mean IDBO of 0.7±0.07 jtg/kg
blntcrpolated from two data points
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requirement  for macrophages or T helper cells (Jelinek and Lipsky, 1987), these

results suggest an Ah receptor dependent B cell response.  In terms of cytotoxic

T cells, Clark et al.  (1983)  was first to report data suggesting that TCDD  and

PCB isomers  suppressed in vitro CTL responses  of B6  and D2  mice through an Ah

receptor-dependent mechanism.   Subsequently, Kerkvliet et al.  (1990b) reported

that  B6 mice  congenic  at the  Ah  locus  showed Ah-dependent  sensitivity to

suppression   of  the  CTL  response  following   exposure  to  either  TCDD  or

3,4,5,3',4',5'-HxCB.   Furthermore,  the  potency of  TCDD  and  of  three HxCB

congeners  to suppress the CTL response of Ahbb-B6 mice directly correlated with

their  relative binding affinities for the Ah receptor (Table 4-2).   The ID50 of

TCDD  for suppression of  the CTL response  in B6  mice was 7.0 pg/kg .

In  summary,  the data  relating HAH  immunotoxicity,  at  least in part,  to Ah

receptor-dependent events are convincing.   However,  it should be emphasized that

all of the data have been obtained from studies  in inbred mice  using an acute or

subacute exposure regimen. Except  for thymic  atrophy, structure-immunotoxicity

relationships in other species including rats have not been established, and the

availability of inbred strains of other species with defined Ah genotype are not

currently available.  The importance of Ah receptor mediated events in chronic,

 low-level HAH immunotoxicity also  remains to  be  established.   Morris  et  al.

 (1992) have recently reported that the sensitivity of D2 mice  to  TCDD-induced

 suppression of  the antiSRBC response  increased  significantly  when TCDD  was

 administered  daily over  two  weeks  rather  than   as an  acute  single  dose.

 Unfortunately,  in  these  studies, the  lowest dose of  TCDD  produced near-maximum

 suppression of the  antiSRBC response of B6C3F1 mice in the acute exposure model,

 precluding  the detection of  any similar  increase in  sensitivity of the B6C3F1

 mice  to  chronic dosing.   In  contrast to  these findings, Vecchi  et al. (1983)

 reported  that multiple exposures to TCDD  (2 M9/kg  for 5 weeks or 0.5 /jg/kg for

 8 weeks)  did  not   increase the  sensitivity of D2   mice  to suppression of the

 antiSRBC  response.  Thus, the  basis  for  any  change  in  potency resulting  from
       ^The dose of TCDD required to suppress the CTL response reported by Kerkvliet et al. (I990b) is significantly greater than that
 reported by Clark et al. (1981), who reported CTL suppression following four weekly doses of 0.1 fig/kg TCDD.  Clark et al (1983) also
 reported that doses of TCDD as low as 4 ng/kg to B6 mice suppressed the in vitro generation of CTL and thai the suppression was Ah dependent.
 The potency of TCDD described in the Clark el al. (1981, 1983) studies has not been corroborated by other laboratories.

                                         4-9                               08/06/92

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                                      TABLE 4-2
TEF0 Based on the ID50  for  Suppression of Alloantigen  
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multiple treatment  or  chronic  exposure to TCDD  and  the  role  of Ah  receptor-

mediated events in  the phenomenon  remain to  be elucidated.

4.3.    TOXIC EQUIVALENCY  FACTORS  (TEFs) FOR  IMMUNOTOXICITY

      Based  on  the  available  data  from  mice,  the  majority  of  the  immunotoxic

effects of HAH appear to be mediated via the  Ah receptor.  Thus,  the toxicity of

different  HAH  congeners  can  be  compared  by  calculating  TEFs.   TEFs  based  on

acute, single dose  exposure  (oral or  intraperitoneal) of B6 mice to various HAH

for suppression of  the  antiSRBC  response and the CTL response are presented in

Table 4-1 and 4-2,  respectively.  As  shown in Table 4-1, the potency of TCDD to

suppress the antibody response to SRBC has been reported by several laboratories,

with remarkable agreement2 in the  ID50 value  of 0.7 jug/kg in B6 mice.   The ID50

of B6C3F1 mice is similar (<1 /jg/kg)  (House et al.,  1990) or  slightly higher (1.2

pg/kg)  (Holsapple  et  al., 1986a)  in comparison  to  B6 mice.    This  data  thus

provides  a  well-defined  base value  to use  in calculating TEFs  for  other HAH

congeners  in the  context of suppression of the antiSRBC response.

      However,  in  contrast to the reproducible data on TCDD, the accuracy of the

derived TEFs for  other HAH congeners  shown in Table 4-1 is difficult to evaluate

since few  congeners have  been examined in more  than one  study.   In the few cases

where the  same congener has been evaluated independently, discrepancies in the

data exist.   For  example,  both Davis  and Safe  (1990)  and Silkworth et  al. (1984)

evaluated   the  potency  of  the  2,3,4,5,3',4'-HxCB   congener   in the  antiSRBC

response.   Based  on the ID50's from the two data sets, the  respective TEFs differ

by almost  two orders of magnitude  (IxlO"3 versus 2xlO"5).   When the same congener

was  compared to  TCDD  for suppression of  the  CTL  response, the  TEF  was  1x10

 (Table 4-2).  The basis for these discrepancies is unknown.   Thus, the data base
       ^Several laboratories have reported that the antibody response to SRBC is sensitive to suppression following acute exposure to TCDD,
 either inlraperitoneally or orally, at doses < I fig/kg. In contrast, Clark et al. (1981) reported thai 4 weekly ip doses of 10 but not 1 or 0.1
 US/kg TCDD significantly suppressed the antiSRBC response in B6 mice. The chronic dosing protocol used by Clark does not readily explain
 his decreased potency since Vecchi et al (1983) reported that five weekly doses of 2 fig/kg or eight weekly doses of 0.5 pg/kg TCDD signifi-
 cantly suppressed the antiSRBC response. Likewise, when total doses of 0.2 or 1 ng/kg TCDD were given as a single dose or divided into five
 daily doses, the divided dose produced slightly more suppression that the single dose (Table 4-3) (Kerkvliet and Deyo, unpublished data). In
 addition, the route of antigen challenge [intravenous (used by Clark) versus inlraperiloneal (used by Vecchi)] does not appear to greatly influence
 the degree of suppression of the anliSRBC response produced by TCDD (Table 4-4) (Kerkvliet and Deyo, unpublished data). Thus, the basis
 for the discrepancies between the data of Clark el al. (1981,  1983) and other laboratories regarding the potency of TCDD to suppress the
 antiSRBC response is unknown.
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                            TABLE  4-3
Effect of Single Versus Multiple Dosing with TCDD on Suppression
        of the Antibody Response to SRBC in C57B1/6 Mice
                      Plaque-Forming  Cells/106 Spleen Cells
                                   (mean  ±  SD)
Total Dose
Single3
                                                 Multiple1
                       2460±657
                                              3846±1618
0.2
                       18791445 (76)
                       2356±592 (61)
 1.0
                       1293±285 (52)c
                       1143±208 (30)'
 aTotal dose of TCDD given once two days prior to SRBC injection

 blotal dose of TCDD divided  into  five  equal  doses  administered on
  days -7 to -2 prior  to SRBC injection

 cp<0.01
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TABLE 4-4
Influence of Route of Antigen Challenge on Suppression of the
Antibody Response to SRBC in C57B1/6 Mice3
Dose of TCDD
(^9/kg)
0
0.2
1.0
Plaque-Forming Cells/10b Spleen Cells
(mean ± SD)
Intravenous
1151±367
623±324 (54)
4661212 (40)b
Intraperitoneal
1812±872
1197±519 (66)
697±163 (38)b
a2.5xlO^ SRBC  were injected  intravenously  or  intraperitoneally
 2 days after  oral dosing  with TCDD; plaque-forming  cells were
 measured 5 days later.

bp< 0.01
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for TEF  comparisons using  immunotoxicity  data must be  expanded considerably
before TEFs can be used with confidence in risk assessment.
4.4.   INTERACTIONS BETWEEN HAH
     If the immunotoxicity  of TCDD and  structurally related HAH depend on Ah-
receptor mediated mechanisms, then co-exposure to subsaturating  levels of more
than  one Ah  receptor ligand should produce  additive  effects.   An additive
interaction has  been  demonstrated in mice co-exposed to 1,2,3,6,7,8-HxCDD and
1,2,3,4,6,7,8-HpCDD, two relatively strong Ah receptor ligands (Kerkvliet et al.,
1985).   On the  other hand,  Davis and  Safe  (1988, 1989)  have reported that
co-exposure of mice to an immunotoxic dose of TCDD and  a subimmunotoxic  dose  of
different  commercial  Aroclors or different  PCB  congeners resulted  in  partial
antagonism of TCDD suppression of the antiSRBC  response.  In limited studies,  an
apparently similar antagonism was observed following co-exposure to 2,3,7,8-TCDF
 (10 pg/kg) and TCDD (1.2 pg/kg)  (Rizzardini et al., 1983). The mechanism for the
 antagonism has not been fully elucidated, but the  effects  are  consistent with
 competition   for  binding at  the Ah receptor,  since  the  weaker agonist was
 administered in excess compared to TCDD.  Furthermore,  Silkworth et al. (1988)
 and Silkworth and O'Keefe (1992)  have shown that the immunotoxicity of TCDD can
 be modified  by  coexposure  to other  HAH present as co-contaminants of actual
 environmental samples  from Love Canal.   Such interactions  complicate hazard
 assessment of mixtures based on TEFs and may preclude dependence on TEFs without
 biological response evaluation for risk assessment.
 4.5.   SENSITIVE TARGETS FOR HAH IMMUNOTOXICITY
      Despite considerable  investigation, the cells that  are  altered  by  HAH
 exposure  leading to  suppressed immune  function have  not  been unequivocally
 identified.  The main reason for the lack  of definitive progress in this area is
 the conflicting data reported from different laboratories regarding the ability
 of TCDD to  suppress  lymphocyte functions when examined "ex vivo" or in  vitro.
 As discussed in a  subsequent section of this  document,  the in  vitro effects of
 TCDD are greatly influenced by the in vitro culture  conditions, which may explain
 the  discrepancies  in effects observed  in different laboratories.
       In contrast  to in vitro  studies,  the  in vivo  immunotoxicity of  TCDD,
 expressed in terms of suppression of the antiSRBC response of B6 or B6C3F1 mice,
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                         DRAFT—DO  NOT  QUOTE OR CITE






is highly reproducible between laboratories. Since the magnitude of the antiSRBC



response depends on the concerted interactions of antigen-presenting cells (APC),



regulatory T cells (helper  and suppressor),  and B cells, this response has been



used most widely to evaluate target cell sensitivity to HAH.  In addition, the



antibody response to SRBC  can be  modulated by many non-immunological factors,



including  hormonal  and  nutritional variables, and HAH  are  known  to  affect



numerous endocrine  and  metabolic  functions.   These  latter  effects will be



apparent only in  in vivo studies, while only direct effects of HAH on APC and



lymphocyte functions would be evident  following in vitro exposure to HAH.  To



date, direct  in vitro effects  of TCDD  on purified B  cell  activity have been



reported (Holsapple et  al.,  1986a;  Morris and Holsapple,  1991; Luster et al.,



1988), while direct effects on  macrophages and T  cells in vitro have not been



described.  (The in vitro effects of TCDD will be  discussed  in  more  detail  in  a



subsequent section of this document.)



     Kerkvliet  and Brauner (1987)  compared the sensitivity of antibody responses



to antigens that differ  in their requirements for  APC and T  cells as an  in  vivo



approach  to  evaluate  the  cellular  targets  of   1,2,3,4,6,7,8-HpCDD   humoral



immunotoxicity.  The T-helper cell independent (TI)  antigens, DNP-Ficoll and TNP-



LPS, were  used  in these studies.   These TI antigens differ from each other  in



their  requirement for  APC  (higher  for DNP-Ficoll) and  their sensitivity  to



regulatory (amplifier and suppressor) T  cell influence  (DNP-Ficoll is sensitive,



TNP-LPS is not)  (Braley-Mullen,  1982).  Obviously, all antibody responses require



B cell  differentiation  into  antibody-secreting plasma cells.   Although  HpCDD



produced dose-dependent  suppression of  the antibody response to all  three



antigens,  sensitivity to suppression directly correlated with the sensitivity of



the  response  to T cell regulation.   The ID50 values were  53,  127  and 516  pg/kg




 for  SRBC, DNP-Ficoll, and TNP-LPS, respectively.  These results were interpreted



 as follows:   If  one  assumes that  B cell  function is targeted in  the  TNP-LPS



 response,  then  regulatory T cells  and/or APC may  represent the more sensitive



 target  in the  SRBC  and DNP-Ficoll responses.  The difference  in  sensitivity



 between the SRBC and DNP-Ficoll responses  suggest  that the T helper cell may be



 a particularly  sensitive target.   The  differential sensitivity of the  antibody
                                      4-15
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                          DRAFT—DO NOT QUOTE OR CITE

responses to  TNP-LPS versus SRBC has  been corroborated  in  TCDD-treated mice
(House et  al. 1990; Kerkvliet  et  al.,  1990a).   Thus,  the  exquisite  ±n vivo
sensitivity of the antibody response to SRBC would  appear to depend on the T cell
and/or APC components of the response rather than the B cell,  unless the B cells
that respond  to  SRBC are different from the B cells  that respond to  TNP-LPS.
Currently, evidence for such a difference is lacking.  However,  this interpreta-
tion conflicts with the "ex vivo"  data of Dooley and Holsapple  (1988).  Using
separated  spleen T cells, B cells and  adherent  cells from vehicle- and TCDD-
treated mice, they reported that B cells from TCDD-treated mice were functionally
compromised in in vitro antibody responses but  T cells and macrophages were  not.
The basis  for'these discrepant  findings has not been  established.   However,  it
is possible that the effects of TCDD on T cells are indirectly induced following
antigen  exposure such that removal of the  cells from the TCDD environment of the
host prior to antigen challenge would preclude detection of T cell dysfunction.
This  interpretation is supported by  the findings  of Tomar and Kerkvliet (1991)
 that  spleen  cells  taken from  TCDD-treated mice were not  compromised  in their
 ability  to reconstitute the antibody response of lethally  irradiated mice.  This
 interpretation is  also  consistent with the  reported  lack of direct effects of
 TCDD and  other  HAH on T cells in  vitro  (Clark  et  al., 1981;  Kerkvliet and
 Baecher-Steppan, 1988a).
      While the  direct  effects of  TCDD   on  T cells  in  vitro  have  not  been
 demonstrated, it is clear that  functional T cell responses generated in vivo are
 compromised  following in vivo exposure.   Nude  mice that are  congenitally T cell
 deficient are significantly less sensitive to  HpCDD-induced  immunotoxicity when
 compared  to  their T cell-competent littermates  (Kerkvliet  and Brauner, 1987)
 Likewise, exposure to TCDD or HxCB  suppresses the development  of  CTL activity
 following alloantigen  challenge  (Kerkvliet  et al., 1990b).   Interestingly, the
 sensitivity  of the CTL response to suppression by TCDD is approximately the same
 as the  sensitivity of  the  antibody  response  to  TNP-LPS  (both  have an ID50  of
 approximately 7  /jg/kg  in B6 mice)  (Kerkvliet et al.,  1990a,b).  since the B cell
 response to TNP-LPS and the CTL response to  I-A"  P815 alloantigen have little
  requirement for antigen-presenting  cells or classic  CD4+ T helper cells,  these
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                                                                        08/06/92

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                         DRAFT—DO  NOT QUOTE OR CITE

results suggest that the differentiation of B cells and CD8+ CTLp to effector
cells have an equivalent "functional" sensitivity to TCDD.
     The influence  of  TCDD exposure on  regulatory T cell  functions has been
addressed in a limited  number of  studies.   Clark et al.  (1981) first proposed
that T suppressor cells  were induced by TCDD in the thymus  that  were responsible
for the suppressed CTL response.  However, increased suppressor cell activity in
peripheral lymphoid tissue was not  observed in mice exposed  to TCDD  (Dooley et
al.,  1990)  or  3,4,5,3',4',5'-HxCB  (Kerkvliet and Baecher-Steppan 1988b).   In
terms of T helper cell activity, Tomar and Kerkvliet (1991) reported that  a dose
of 5 /jg/kg TCDD  suppressed the in vivo generation of carrier-specific T  helper
cells.  Lundberg et  al.  (1990) reported that thymocytes from B6 mice treated with
TCDD  (50  jjg/kg)  were less capable  of providing  help for an in vitro antiSRBC
response.  However, Clark et al.  (1983) reported in ex vivo studies that T cells
from  TCDD-treated mice  produced normal levels of  IL-2.  The in vivo effect of
TCDD  on the production of IL-2 as  well  as other  lymphokiries  important  in the
development  of  an antibody response (e.g.,  IL-4,  IL-5) have not been reported.
      The  influence  of  TCDD exposure  on B  cell  function  has been addressed
primarily in in  vitro studies.  The issue is difficult to address in  vivo given
that  most B  cell responses (except  perhaps anti-LPS responses) are dependent on
interactions with T cells  and macrophages.  In vitro studies have described the
direct effects of TCDD on the activation  and differentiation of purified B cells
 (Luster et al.,  1988;  Morris et  al.,  1991).   These studies suggest that  TCDD
 inhibits the terminal  differentiation of B  cells via alteration of an early
 activation event (Luster et al.,  1988).  Increased phosphorylation and tyrosine
 kinase activity  in  TCDD-treated  B  cells may underlie this  B cell dysfunction
 (Kramer et al.,  1987;  Clark et al., 1991a).
      Macrophage functions have also been  examined following TCDD exposure and
 generally found to be  resistant  to suppression  by TCDD  when assessed ex vivo.
 Macrophage-mediated phagocytosis,  macrophage-mediated tumor cell cytolysis  or
 cytostasis, oxidative  reactions  of neutrophils  and macrophages,  and  NK (cell
 activity) were not suppressed  following  TCDD  exposure, with doses as high as 30
        failing   to  suppress NK  and macrophage  functions  (Vos  et  al., 1978;
                                      4-17
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                          DRAFT—DO NOT  QUOTE  OR CITE

Mantovani et  al.,  1980).   A potentially important exception  is the reported
selective  inhibition  of  phorbol  ester-activated  antitumor   cytolytic  and
cytostatic activity of neutrophils by TCDD (Ackermann et al., 1989).
     On the other hand, it is interesting to note that the pathology associated
with TCDD toxicity often  includes neutrophilia  and an inflammatory response in
liver and skin characterized by activated macrophage and  neutrophil accumulation
(Weissberg and Zinkl,  1973;  Vos  et  al.,  1973; Vos et al., 1974;  Puhvel et al.,
1988).   While  these  observations  may  simply  reflect a  normal inflammatory
response to tissue injury, there is some preliminary experimental evidence that
suggests  inflammatory cells may be activated by TCDD  exposure.  For example,
Alsharif  et  al.  (1990) recently reported that  TCDD increased  superoxide anion
production  in rat  peritoneal macrophages. In addition,  it has  been shown that
TCDD  exposure  results in  an enhanced inflammatory response   following SRBC
challenge (Kerkvliet and Brauner, 1990b). This  effect of TCDD was characterized
by a 2-4 fold  increase in  the  number  of neutrophils  and macrophages  locally
 infiltrating the intraperitoneal site of  SRBC injection.  However, the kinetics
 of the cellular influx was  not  altered by TCDD.  Likewise, the expression  of
 macrophage activation markers (I-A and F4/80) and the antigen-presenting function
 of the peritoneal exudate cells was unaltered by TCDD.  Thus, the effect of TCDD
 appeared to  reflect  a quantitative  rather   than a qualitative change in  the
 inflammatory response.   Importantly, TCDD-induced  suppression  of the antiSRBC
 response could  not  be overcome by increasing  the  amount of antigen  used  for
 sensitization,  suggesting  that  enhanced antigen clearance/degradation by  the
 increased numbers of  phagocytic cells  (e.g.,  decreased antigen load)  was  not
 responsible for the decreased antibody  response in TCDD-treated mice.  Thus, the
 relationship, if any, between the  inflammatory  and immune effects of TCDD remain
 to be elucidated.
      One mechanism  by  which TCDD  and  related  HAH  may  augment inflammatory
 responses is via enhance production of inflammatory mediators such as interleukin
 1 (IL-1) and TNF.  Recent evidence suggests that the long-recognized hypersuscep-
 tibility of  TCDD-  and  PCB-treated animals to endotoxin  (LPS)  (Thomas  and
 Hinsdill, 1978; 1979; Vos et al.,  1978; Loose et al.,  1979) may be related to  an
 increased production of TNF and/or IL-6 in the chemically treated animals (Clark
                                       4-18                             08/06/92

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                          DRAFT—DO  NOT  QUOTE OR CITE






et al.,  1991b;  Taylor  et al.,  1990; Hoglen  et al.,  1992).   The  ability of



methylprednisolone  to  reverse  the  mortality  associated with  TCDD/endotoxin



treatment is also consistent with an  inflammatory  response  (Rosenthal et al.,



1989).  Similarly, increased inflammatory mediator production may underlie the



enhanced rat paw edema response  to carrageenan  and  dextran in TCDD-treated rats



(Theobald et  al.,  1983;  Katz et al.,  1984).   Limited, preliminary  data is



available to indicate that the production of inflammatory mediators  such as TNF



(Taylor et al.,  1990; Clark et al.,  1991b) and IL-6 (Hoglen et al.,  1992) may be



increased in HAH-treated animals.  Serum complement activity, on the  other hand,



has been reported to be suppressed in dioxin-treated mice (White  et  al., 1986),



although  enhanced activity  was reported  at  the  lowest exposure  level when



1,2,3,6,7,8-hexachlorodioxin was tested.   A primary effect  of TCDD on IL-1 is



supported by  the recent findings of  Sutter et  al.  (1991)  that the IL-lp gene



contains a ORE.   Likewise, Steppan and Kerkvliet (1991) have  reported that under



some  exposure conditions TCDD  increased  the  level of mRNA for  IL-1 in TCDD-



treated  IC21  cells,  a macrophage cell line  derived from  B6  mice.  On  the other



hand.  House et  al.  (1990)  reported  that inflammatory  macrophages obtained  from



TCDD-treated mice produced control  levels of IL-1 when examined ex vivo.  Thus,



the effect of TCDD on inflammatory mediator  production may be a "priming effect"



and require co-exposure to antigen or  LPS.  The influence  of TCDD on inflammatory



mediator production and action  is an  important area for  further  study.



      Since the  rapid influx of phagocytic cells to  the site of pathogen invasion



is an important factor in host  resistance to  infection,  the ability of TCDD to



augment the production of inflammatory chemoattractive mediators would imply that



TCDD  exposure could  result in  enhanced host  resistance.   However, since  TCDD



exposure is, at the same time, immunosuppressive, resulting in decreased specific



immune responses generated by T and  B  lymphocytes, the  overall  impact of  TCDD



exposure on  disease susceptibility  will likely vary depending on the nature of



the  pathogen and  the major mode of  host response to the  specific infectious



agent.  Such effects may in fact help to explain  the disparate effects of  TCDD



 in different host resistance models that have been previously reported.
                                      4-19
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                          DRAFT—DO NOT QUOTE OR  CITE

4.6.   INFLUENCE OF TCDD ON HOST RESISTANCE TO DISEASE
     The  ability of  an  animal  to  resist and/or  control  viral,  bacterial,
parasitic and neoplastic diseases  is determined by both nonspecific and specific
immunological  functions.   Decreased functional  activity in any  immunological
compartment may result in increased susceptibility to  infectious  and neoplastic
diseases.   In terms  of risk assessment,  host resistance is  often accorded  the
"bottom line" in terms of relevant immunotoxic endpoints.  Animal host resistance
models that mimic human disease are available  and have been used to assess  the
effect of TCDD on altered host resistance.
      TCDD exposure increases  susceptibility to challenge with the gram negative
bacterium Salmonella.  TCDD was given per os at  0.5 to 20 ^g/kg once a week for
 4 weeks to male 4-week-old C57Bl/6Jfh (J67) mice  and challenged 2  days after the
 fourth dose   (when  mice were  8   weeks  old)  with either  Salmonella hern or
 tferpesvirus  suzs  (also known as  pseudorabies virus).   Results with  S.  2>ern
 indicated there was  an increased mortality at  1 ^g  TCDD/kg (total  dose  of 4
 pg/kg)  and a reduced time to death after bacterial challenge with 5 »q TCDD/kg
  (total doae of 20 /jg/kg) / In contrast, the same doses of TCDD did not alter the
 time to death or the  incidence of mortality following  H.  suis infection  (Thigpen
 et al.,  1975).  A TCDD feeding study by Hinsdill  et al.  (1980) also demonstrated
  increased  susceptibility of 7-week-old  Swiss Webster  outbred  female mice to
  Salmonella  typhimurium var.  Copenhagen.   Mice  were  fed  control feed or  feed
  containing 10,  50, or 100 ppb TCDD for 8 weeks,  after which they were  injected
  intravenously with 103'5  S. typhimurium var. Copenhagen.   Results indicated  that
  50 and  100 ppb TCDD  increased mortality  from  Salmonella and shortened the  time
  to death while 10 ppb caused  an increased bacteremia.   Vos  et al.  (1978) reported
  that TCDD resulted in a reduced resistance to endotoxin (Eschericnia coli O 127:B
  8  lipopolysaccharide)   and  suggested  that  the  increased susceptibility  to
  Salmonella caused by TCDD  may be  due  to the  lipopolysaccharide or endotoxin
  present on this gram negative bacterium.  Vos  et al.  (1978) demonstrated reduced
  resistance to endotoxin with a  single oral dose of  100 Ug TCDD/kg  using 3- to
  4-week-old outbred female mice  and challenged with endotoxin 5  days later.  Vos
  et al.  (1978) also reported  enhanced mortality from the  intravenous injection of
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                         DRAFT—DO NOT QUOTE OR CITE






endotoxin 2 days after the  final oral  dose of TCDD  (1.5, 5, 15 or 50 pg/kg once



a week for 4 weeks)  in 3- to  4-week-old male outbred Swiss mice.  These studies



indicate a  reduced  resistance to  endotoxin after  single  or  multiple doses of



TCDD.   Thomas and  Hinsdill  (1979),  using S.  typhimurium lipopolysaccharide,



demonstrated a reduced resistance  to endotoxin  in the offspring of female Swiss



Webster mice fed TCDD prior to mating, during gestation and between parturition



and  weaning.   Rosenthal et  al.{1989) used female B6C3F1,  DBA/2, as  well as



congenic mice to demonstrate that acute doses of 50, 100 or 200 fjg TCDD per os



increased endotoxin-induced mortality  in B6C3F1 mice, associated with hepatotox-



icity and decreased clearance of the endotoxin.  D2 and Ah^ congenic mice were




relatively resistant to this  effect implicating Ah receptor dependent mechanisms



in endotoxin hypersensitivity.



     White et al.(1986) reported that Streptococcus pneumoniae, a  gram positive



bacterium that does not contain endotoxin, caused  increased mortality in 5- to



6-week-old  female  B6C3F1  mice  after subchronic  oral administration of  TCDD



(1 pg/kg  for 14 days) and  challenged with S. pneumoniae intraperitoneally 1 day



after  the  last  treatment.   The  1,2,3,6,7,8-HCDD  isomer also  resulted  in  a



dose-dependent  increase in susceptibility to S. pneumoniae.



     Enhanced susceptibility to viral disease has also been reported  after  TCDD



administration.  Clark et al. (1983) injected TCDD  intraperitoneally once a  week



for  4  weeks and  challenged  mice  7-22 days later  with Herpes simplex type II



strain  33  virus.  Mice receiving  TCDD at  0.04, 0.4,  or 4.0  pg/kg weekly  (total



dose of 160,  1600 and 16,000 ng/k) all had significantly  enhanced mortality to



Herpesvirus type II infection.   House et al.   (1990) also reported an enhanced



susceptibility   to  viral  infection  following  low  level  single  dose   TCDD



administration  intraperitoneally,,  B6C3F1 female mice, 6-8 weeks  of  age,  were



challenged with Influenza/A/Taiwan/1/64  (H2N2) virus 7-10 days following TCDD.



TCDD administration at 10, 1.0  and  0.1 pg/kg decreased resistance to virus.



     TCDD exposure also results in more severe parasitic diseases. Tucker et al.



 (1986)  studied  the  effects of TCDD  administration on Plasmodium yoelii  17  XNL,—



a nonlethal strain of malaria,  in 6- to 8-week-old  B6C3F1  female mice.  A single



dose of TCDD at  5 pg/Kg or 10 pg/kg per os resulted in increased susceptibility
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                          DRAFT—DO NOT QUOTE OR CITE

to P.  yoelii.    The peak  parasitemia  was greater  and  of longer  duration in
TCDD-treated animals  than in controls, the difference  being  significant at 5
pg/kg on day 10 and at 10 /jg/kg on days 12 and 14.
     Luster et al.  (1980b) demonstrated enhanced growth of transplanted tumors
in mice treated with TCDD at doses of 1.0 or 5.0 pg/Kg in  B6C3F1 mice.  Mothers
were given TCDD by  gavage at day  14  of gestation and  again on days  1, 7  and 14
following birth; host resistance studies were performed 6-8 weeks after weaning.
This exposure protocol resulted in an increased incidence of PYB6 tumors in pups
from dams receiving repeated doses of 1.0 but not  5.0 ^g  TCDD/Kg.
     While  it is  clear  that TCDD adversely  affects numerous host resistance
models detailed  above,   the effects  of  TCDD  on  susceptibility  to  Listeria
nonocytogenes infections  are  ambiguous.   The disparate results  may  reflect
 different study designs including dose, route, single versus multiple administra-
 tions, mouse strain,  age or  sex.  However,  it is clear that TCDD, under certain
 conditions,  results  in  increased susceptibility to Listeria.   Hinsdill et al.
 (1980)   reported   the  increased susceptibility  of 7-week-old  Swiss  Webster
 outbred female mice to Listeria.   Mice were fed control feed or feed containing
 10 or 50 ppb TCDD for 8 weeks, after which they were injected intravenously with
 105 iisteria.  Results indicated that the 50 ppb diet  increased bacteremia and
 mortality.  Luster et al. (1980b) used doses of  1.0 or  5.0 ug TCDD/Kg in B6C3F1
 mice.  Mothers were given TCDD by gavage at day 14 of gestation and again on days
  1, 7 and 14 following birth  and host resistance studies were performed 6-8 weeks
  after weaning.   This exposure protocol  resulted  in an  increased  susceptibility
  to  Listeria  in pups from  dams receiving  repeated doses of  5.0 pg  TCDD/Kg.
  However, Vos et al. (1978)  reported that oral administration of  50  pg TCDD/kg
  once  a  week for  4 weeks  to 3-  to 4-week-old  male  Swiss  mice followed  by
  intravenous challenge 4 days  after  the  last dose with Listeria had no affect on
  nonspecific phagocytosis and  killing of Listeria.  House et al.  (1990) used
  B6C3F1 female mice,  6-8 weeks of age, and challenged intravenously with Listeria
  7-10 days  following a single dose of TCDD at 10, 1.0 and 0.1 »g/kg. TCDD did not
  enhance mortality to Listeria.
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                          DRAFT—DO NOT QUOTE  OR CITE






     In summary,  results from host resistance studies provide  evidence that



exposure  to TCDD  results in  increased  susceptibility  to  bacterial,  viral,



parasitic and neoplastic disease.  These effects are observed at low doses and



likely result from TCDD-induced suppression of immunological function.  However,



it is  interesting  that  the role of the Ah  receptor has  not been addressed in



terms of host resistance models  except in  studies on endotoxin hypersensitivity



by Rosenthal et al. (1989).  Furthermore, the specific immunological functions



targeted  by TCDD  in  each of the  host resistance models remain to  be fully



defined.



4.7.   IN VITRO IMMUNOTOXIC EFFECTS OF HAH



     Investigators in the field of TCDD immunotoxicity have long acknowledged the



difficulties in consistently demonstrating the immunotoxicity of TCDD when cells



from treated animals are tested  ex  vivo as well as when TCDD is added to  culture



in vitro.   While effects  following  in vitro  and ex  vivo exposure  to TCDD on



lymphocyte  functions  have been  reported  (Tucker et al.,  1986;  Luster et al.,



1988;  Dooley  and Holsapple,  1988), other laboratories  have failed to  observe



suppression with in vitro-or ex  vivo exposure  to dioxin  (Lundberg et al., 1990;



Clark et al.,  1981; Kerkvliet and Baecher-Steppan, 1988b; Kerkvliet,  unpublished



data).  In addition, the effects of TCDD seen in vitro are sometimes inconsistent



with those observed after in vivo assessment  of immunotoxicity.  For example, the



rank order of sensitivity to suppression of T helper cell-dependent and T helper



cell-independent  antibody responses seen  in vivo (Kerkvliet and Brauner 1987;



1990a; House et al.,  1990) is not seen in vitro (Holsapple et al., 1986a; Tucker



et al., 1986)  suggesting different  cellular  targets may be affected following in



vitro exposure to TCDD.   More importantly, some data suggest that suppression of



the in vitro antibody response may  occur independent of the Ah receptor.  Tucker



et al. (1986) and Holsapple et al.  (1986a) reported that direct addition  of TCDD



in  vitro  suppressed  the antibody  response to SRBC.   However, based  on the



response  of cells from congenic mice as  well as a limited  structure-activity



study,  the data  of  Tucker et  al. (1986)  supported  an Ah  receptor-dependent



suppression while  the data of Holsapple et  al.  (1986a) did  not.  In the latter



study, the magnitude of  suppression was comparable using  cells  from responsive
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                          DRAFT—DO NOT QUOTE OR CITE

B6C3F1 or congenio heterozygous (B6-Ahbd) mice  compared to nonresponsive D2 or
homozygoua B6-Ahdd  mice.   In addition,  they reported that  the 2,7-dichloro-
dibenzo-p-dioxin  congener  which lacks  affinity  for  the  Ah receptor,  was
equipotent with TCDD in suppressing the in vitro response.
      in  other studies, Davis and Safe  (1991)  directly compared  the in vitro
Btructure-immunotoxicity  relationships for a series of HAH congeners which show
>14,900 fold-difference in in vivo immunotoxic potency. Results of these studies
indicated  that all of the congeners  were equipotent  in  vitro and  produced  a
similar  concentration-dependent suppression of the in vitro  antiSRBC  response
using cells from either B6 or D2 mice.  Co-exposure to the Ah-receptor antagonist
a-napthoflavone antagonized the  immunosuppression induced  by either  TCDD  or
 1,3,6,8-TCDF (a weak Ah receptor agonist).  Collectively,  the results supported
 a mechanism of suppression in vitro that was independent  of  the Ah receptor.
      The basis for these variable  effects of  TCDD in vitro  are  currently  not
 known.   However,  recent studies by Morris et al.  (1991) demonstrated that the in
 vitro effects of  TCDD  on  the antiSRBC response were critically dependent on the
 type and concentration of the serum used in the in  vitro  culture.   Only 3 of 23
 lots of serum were able to support a full dose-responsive suppression, and, in
 serum-free cultures, TCDD caused a 15-fold enhancement of  the antiSRBC response.
 Thus, differences in media components used in  in vitro cultures may account  for
 the  different  effects seen  in  vitro  in different laboratories.  Other factors
 such as the TCDD  carrier/solvent  used,  the calcium  content of  the media, or
 procedures used for preparation of  spleen cell suspensions may all contribute to
 variable  effects of TCDD in vitro.
      The  obvious question relates  to the  relevance of the in vitro findings to
 the  in  vivo immunotoxicity.  In  this respect,  it  is  important to note that the
  concentrations of TCDD  required for in  vitro  suppression   of immune  function
  (1-30X10'9 M) of murine  lymphocytes is  several orders of magnitude higher  than
  the concentration found  in lymphoid tissues  following exposure in vivo to an
  immunotoxic dose of TCDD (Neumann  et al.,  1992).  The amount of TCDD associated
  with isolated spleen  cells  obtained  from mice 2 days  following treatment with 5
  pg/kg 3H-TCDD was 2xlO'15 M  per 107 spleen cells.   Importantly,  as much as 50% of
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                         DRAFT—DO NOT QUOTE OR CITE






the radioactivity  associated with whole  spleen tissue  was recovered  in  the



stromal and/or capsular  material  (i.e.,  splenic tissue  that  resisted passage



through the mesh screens used for preparation of spleen cell suspensions).  These



findings suggest that the most potent effects of TCDD on immune  function in vivo



may be induced indirectly by effects  on nonlymphoid  cells,  or that based on the



delivered  dose of  TCDD,  this molecule is more  toxic  than previously thought.



Alternatively, TCDD effects in vivo on nonlymphoid cells  may amplify the direct



effects of TCDD on  lymphoid tissue.  Certainly,  additional studies are  needed to



elucidate the serum components that are permissive for suppression or enhancement



of  immune responses  in  vitro  and to determine  their  relevance  to in vivo



conditions.  Such studies are also likely to provide  insight into the mechanisms



of TCDD interaction with lymphoid cells.



4.8.   INDIRECT MECHANISMS OF HAH IMMUNOTOXICITY



     The difficulty in demonstrating  consistent, direct effects of TCDD in vitro



on  lymphocytes,  the dependence of -those effects on serum components, and the



requirement  for high concentrations of TCDD are all  consistent with  an indirect



mechanism  of TCDD on  the  immune  system.   One potentially important indirect



mechanism  is via effects on the endocrine system.   Several endocrine hormones



have  been shown to  regulate immune  responses, including  glucocorticoids, sex



steroids,  thyroxine, growth hormone and prolactin.   Importantly, TCDD and other



HAHs have  been shown to alter the  activity of all of these hormones  (see chapter



on  endocrine system,  this  document).



     Kerkvliet et  al.  (1990b) reported that exposure of mice to 3,4,5,3',4',5'-



HxCB  followed by  injection  of P815 allogeneic tumor  cells  induced a dose-



dependent  elevation of serum corticosterone concentrations which correlated with



the dose-dependent suppression of the antiP815 CTL response.   However, since



adrenalectomy or treatment with the  glucocorticoid  receptor antagonist RU38486



failed to  protect mice from the immunosuppressive effect of HxCB  (DeKrey et  al.,



1990),  a  role for  the elevated CS in the  suppression of the CTL response seems



unlikely.  Adrenalectomy and hypophysectomy also failed to prevent  TCDD-induced



thymic atrophy in  rats (Van Logten et al.,  1980).



      Using the P815 allogeneic tumor model, Kerkvliet and Baecher-Steppan (1988a)



reported  that male mice  were more sensitive  than  female mice to suppression  of




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                          DRAFT—DO  NOT  QUOTE  OR  CITE

the CTL response by HxCB (Kerkvliet  and  Baecher-Steppan,  1988a).  Castration of
male rats partially ameliorated the immunosuppressive effects of HxCB (DeKrey et
al.,  1992),  suggesting  a  role  for  testosterone  in  suppression  of  the CTL
response.
     Pazdernik and Rozman  (1985) suggest that thyroid  hormones may  play a role
in TCDD immunotoxicity based on the finding that radiothyroidectomy prevented the
suppression of the antiSRBC response in rats treated with TCDD.   However,  since
thyroidectomy alone suppressed immune function, the significance of  the findings
require further  study.
4.9.    ROLE OF THE THYMUS IN HAH  IMMUNOTOXICITY
      Thyraic involution  is one of  the hallmarks of  exposure to TGDD and related
HAH in  all species examined.  In mice, thymic involution occurs by an Ah receptor
dependent mechanism  (Poland  and  Knutson,  1982).   Because the  thymus  plays  a
critical role in  the ontogeny of  T lymphocytes,  thymic involution  is  often
referred to as an immunotoxic effect. However, while an intact thymus is crucial
to the developing immune system during the prenatal and early postnatal period
 of rodents as well as during the prenatal  period  of humans, the physiological
 role played by  the thymus in adult life has not been established.  In animal
 models,  adult  thymectomy  has  little  affect on  the  quantity  or  quality  of
 T lymphocytes, which have already matured and populated the  secondary lymphoid
 organs (Benjamini and Leskowitz, 1991).  Likewise, in humans, childhood and adult
 thymectomy produces  no clearly identifiable adverse  consequences in terms of
 altered  immune  function,  although  some might argue that such studies have not
 been  done.    Based  on  this knowledge,  it  is  not  surprising that  a  direct
 relationship between the effects of  TCDD on the thymus  and immune suppression has
 not been established in studies using adult animals.  In fact,  adult thymectomy
 prior  to HAH  exposure  did not modify TCDD- or HpCDD-induced suppression  of the
 antiSRBC response  (Tucker et  al.,   1986;  Kerkvliet  and  Brauner,   1987).
 Furthermore,  suppression  of immune  responses  occurs  at dose levels of HAH
  significantly lower than those required to  induce thymic  atrophy (Vos et al.,
  1978;  Silkworth and  Antrim,  1985;  Holsapple et  al., 1986b; Tucker et al., 1986;
  Kerkvliet and Brauner, 1990a).  Thus, it is clear that thymic involution does not
  represent a surrogate marker for TCDD immunotoxicity in adult animals.  On the
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                         DRAFT—DO NOT QUOTE OR CITE






other hand, it is possible  that  chronic exposure to TCDD resulting in a chronic



thymic atrophy may produce more delayed,  subtle effects on immune function not



yet identified (Clarke and MacLennan, 1986).



     In  contrast to  adult  animals, congenital  thymic  aplasia or  neonatal



thymectomy results in severe reduction in the number and function of T lympho-



cytes,  and  produces  a  potentially lethal  wasting  disease  (Benjamini  and



Leskowitz, 1991).  Similarly, there is evidence from  studies carried out in the



1970's that rodents exposed to TCDD  or PCBs during the pre/neonatal period are



more sensitive to immune suppression compared to rodents exposed as adults, and



that the prenatal effects are more selective for cell-mediated  immunity (Vos and



Moore, 1974; Faith et  al.,  1978; Luster et al.,  1980b).  TCDD has also been shown



to alter thymocyte differentiation in vitro in cell cultures  (Greenlee et al.,



1985; Cook et al., 1987) and organ cultures (Dencker et al., 1985; d'Argy et al.,



1989) as well as in vivo following prenatal exposure to TCDD  (Blaylock et al.,



1992).  These observations  suggest that altered thymic T cell maturation induced



by  TCDD in  the  thymus may  play  an  important  role in the suppressed immune



function of  prenatally exposed  animals.   However, since TCDD  also influences  B



cell development in the bursa of chick embryos  (Nikolaidis et al., 1990) as well



as lymphocyte stem cells in the  fetal liver and bone marrow of mice (Fine et al.,



1989; 1990), other mechanisms of immunotoxicity are also likely to be important.



4.10.   IMMUNOTOXICITY FOLLOWING PRE/NEONATAL  EXPOSURE  TO  HAH



     The  reported  increase  in susceptibility of very  young  animals to  HAH



immunotoxicity necessitates  a close  examination of the available literature on



prenatal/neonatal  immunotoxic effects.   Several  studies  have  examined  immune



function  in mice, rats  and/or guinea pigs following  exposure to TCDD or  PCB



during  fetal development  (Vos  et  al.,  1973; Vos and  Moore,   1974; Thomas  and



Hinsdill,  1979;  Luster  et  al.,  1980a).



      The results of three major studies in which exposure of the progeny occurred



via placental transfer  and  lactation are summarized  in  Table  4-5.    The most



sensitive  indicator of  TCDD  immunotoxicity in these  studies was an increase in



the growth  of  transplanted  tumor cells  in the offspring  of B6C3F1  mice  (Ah



responsive strain) treated with 1 pg/kg TCDD at 4 weekly intervals.  (Total TCDD



dose to dam was  4 pg/kg; dose to  offspring was not  determined.)  The offspring




                                      4-27                             08/06/92

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                              DRAFT—DO  NOT QUOTE OR CITE
                                            TABLE 4-5

        Inmunotoxic Effects of TCDD in the Offspring Following Pre/Neonatal Exposure to TCDD
Protocol 	 1
s====— =========s==ss====r:
Study #1:
Pregnant B6 or B6C3F1
mice oiven 1, 2, 5 or 15
-7, 0, +7, +14 relative
to parturition on day 0





I

	 	 	
Study «1:
Pregnant Swiss mice fed
diets containing 1.0,
2.5 or 5.0 ppb TCOD for
7 weeks (4 weeks prior
I to and 3 weeks after
I birth)
Study #3:
Pregnant Fischer 344
rats given 1 or 5 /tg/kg
TCDD orally on days -3,
j 0, +7 and +14 relative
I to parturition on day 0
I
Endpoints I
==_=======— =========4=
PYB6 tumor incidence
allograft rejection time
body, thymus, spleen weight
bone marrow cellularity
Con A, PHA blastogenesis
mortality following Listeria
monocytogenes challenge
bone marrow CFU-S colonies
mortality
IPS blastogenesis
anti-SRBC serum liters
endo toxin
thymus weight
PFC response to SRBC
DTK response
anti-SRBC serum liters
LPS and Con A blastogenesis
Listeria- i nduced morta I i ty
allograft rejection time
PHA blastogenesis
DTH response
mortality following Listeria
challenge
body and thymus weight
anti-BGG serum liters
Effect LOAEL
increased
increased
decreased
decreased
decreased
decreased
decreased
increased
--
--
increased
decrease
decreased
decreased
--
--
--
increased
decreased
decreased
increased
decreased
--
1 /tg/kg x 4
2 /ig/kg x 4
5 /ig/kg x 4
5 /tg/kg K 4
5 /ig/kg x 4
5 /ig/kg x 4
5 /tg/kg x *
15 /ig/kg x 4
15 /ig/kg x 4
15 /tg/kg x 4
1.0 ppb diet8
2.5 ppb diet
5.0 ppb diet
5.0 ppb diet
>5.0 ppb diet
>5.0 ppb diet
>5.0 ppb diet
5 /ig/kg x 4
5 /ig/kg x 4
5 /tg/kg x 4
5 jig/kg x 4
5 /ig/kg x 4
>5 /ig/kg x 4
Reference
=====
Vos and
Moore, 1974;
Luster et
al.. 1980
Thomas and II
Hinsdill,
1979



Vos and
Moore,
19774; Failh
and Moore,
1977


I I
aA 1.0 ppb diet  consumed by a 20 g mouse al a rale  of 5 g/day = 0.25 ng TCOD/kg/day.

 LOAEL = Lowesl-observed-adverse-effecl level; BOG  = bovine gamma globulin; LPS = lipopolysaccharide;
 PHA» phylohlmagglulinin;  Con A = Concanavalin A; SRBC = sheep red blood eel s; DTH  =  delayed-lype
 hypersensilivity; PFC = plaque-forming cell; CFU-S = colony-forming  units-spleen
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                          DRAFT—DO NOT  QUOTE  OR  CITE






of Swiss  mice fed a  diet containing 1 ppb TCDD for 7 weeks  showed enhanced



mortality following endotoxin challenge, whi.le the plaque-forming cell response



to SRBC and delayed hypersensitivity response were  suppressed in offspring of



mice fed 5.0 ppb TCDD  diets.   (Estimated daily dose to 20 g dam  consuming 5 g of



5 ppb TCDD diet is equivalent to 1.25 jug/kg TCDD/day.)  Rats appeared  to be more



resistant to the immunotoxic effects of pre/neonatal exposure to TCDD based on



the finding that  5 but not 1 pg/kg  TCDD given four times at weekly intervals



produced  immunotoxicity  in  the  offspring.   Immunotoxic   endpoints  that  were



unaffected by  the highest exposure levels in these studies included blastogenesis



induced by LPS and serum  antibody  titers to SRBC and BQG.



     Two recent studies have examined immune function in offspring of female mice



exposed to TCDD  (Holladay et  al.,  1991) or PCB (Kanechlor  500)  (Takagi et al.,



1987) but that were cross-fostered to unexposed lactating  mice  at birth.  Thus,



exposure was  limited  to in utero exposure.  (It  is  important to recognize that



rodents are born with an  immature  immune  system  that matures in the first few



weeks following birth.  In contssat,  the human immune system is considered to be



more mature at  birth.)   B6 mice exposed to 3.0 fig/kg TCDD on  gestational days



6-14 gave birth to offspring that had significant thymic atrophy and  hypoplasia



measured on gestational day 18 or on day 6 postnatally.  The thymic  effects were



no longer apparent by day 14.  At  7-8 weeks postnatally,  mitogen responses and



antibody  plaque forming  cell response to  SRBC  were unaltered  while  the CTL



response  was  significantly suppressed  compared  to  controls (Holladay et al.,



1991).  These results suggest a selectivity of prenatal TCDD on the CTL  and not



the T  helper  cells involved in  the antibody response to SRBC.   In contrast to



these  results,  Takagi et  al.  (1987)  exposed female  C3H mice per os to 50 mg/kg



Kanechlor  500 twice  per  week for  4 weeks, at which time steady  state tissue



levels were noted.  The offspring  derived from mating to unexposed  males had an



unaltered  antibody response to  the T-independent antigen  DNP-dextran.  On the



other hand, carrier-primed T helper cell activity assessed by adoptive transfer



was significantly suppressed by PCB exposure  when assessed 4 and 7 weeks after



birth, but  fully recovered by 11 weeks. Together,  these  studies confirm prior



studies  to indicate  that T cell   function is selectively altered  by HAH when
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                          DRAFT—DO  NOT QUOTE OR  CITE

exposure IB prenatal.  While both  T  helper cells  and CTL Bhow altered function,
T helper cell activity may recover  faster than CTL function.
     Fine et al. (1990) reported on  TCDD  levels in offspring following maternal
treatment with TCDD  (10 pg/kg) on gestational day 14.  The fetal liver had the
highest concentration on gestational day 18 (235  fg/mg) which declined slightly
by postnatal day "6 to around 100 fg/mg.  The concentration of TCDD in the thymus
on gestation  day 18 was  140  fg/mg, which declined  to 20 fg/mg on day 6  after
birth.  (These thymic TCDD concentrations  are equivalent to 60 to 425 pM assuming
1 kg of tissue is equivalent to 1 L of water.)  TCDD concentrations in the spleen
remained constant at about 40 fg/mg  during the same time frame, while bone marrow
 concentrations were very low (-3  fg/mg).  These  concentrations of TCDD were
 associated with thymic'atrophy  (Fine  et al., 1989) and significant reduction in
 the ability of prothymocytes in liver  and  bone marrow to repopulate an irradiated
 thymus (Fine et al., 1990).
 4.11.  IMMUNOIOXICITY OF HAH IN NON-HUMAN PRIMATES
      A limited number of  studies using nonhuman primates  as surrogate models for
 humans have been conducted to assess  HAH  immunotoxicity.  Immunological effects
 were described in Rhesus  monkeys  and their offspring chronically exposed to TCDD
  at levels  of 5  or  25 ppt for 4 years (Hong et al., 1989).  In the mothers, the
  total number of T  cells  increased  in monkeys fed 25  ppt  TCDD, with a selective
  increase  in CD8+ cells and a decrease in CD4 +  cells.  However, no significant
  effect on T cell function was established when assessed as proliferation response
  to  mitogens,  alloantigens, or xenoantigens.   Natural killer cell  activity  and
  production of antibodies to tetanus  immunization were normal.  In the offspring
  of  TCDD exposed dams  examined 4 years after exposure, a significantly increased
  antibody response to tetanus toxoid immunization was observed which correlated
  with TCDD tissue levels.  The body burden of TCDD in the offspring ranged from
  a low of  290 ppt to a  high of  1400 ppt.  Interestingly, there was  no strict
  correlation between exposure levels and resulting body burden.
       In other TCDD studies, a single injection  of TCDD in marmosets (Callithrix
  j'acchus)  resulted  in  a  delayed  decrease in the percentage of  CD4+ T cells and
  CD20+  B  cells in the blood and  an increase  in the percentage of  CD8+ cells
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                         DRAFT—DO NOT QUOTE OR CITE






(Neubert et  al.,  1990).   The  total  number of T  cells was  not significantly



altered by TCDD exposure.  The CD4 + subset most affected was the CDw29~*~ "helper-




inducer" or "memory"  subset, with significant effects observed after a TCDD dose



of 10  ng/kg.   The NOEL for this effect  was  3  ng/kg TCDD.   Concomitant with



suppression  of  the CDw29  subset in  TCDD  treated animals,  the percentage of



CD4+CD45RA+ cells increased.  This subset has been classified  as  "suppressor-




inducer" or "naive" cells.   The changes  in the T cells subsets were intensified



following  in  vitro culture of  the cells  with mitogen  (Neubert et al.,  1991).



Interestingly, however,  a  recent study  from the  same laboratory reported that



chronic exposure of young marmosets to very low levels of TCDD  (0.3 ng/kg/week



for 24 weeks) produced the opposite effect on the  CD4+CDw29+ subset, resulting




in a significant increase  in this population (Neubert et al.,  1992).  Concomi-



tantly, the  CD4+CD45RA + subset  decreased.  Upon  transfer of the  animals to a




higher  dose  of  TCDD (1.5 ng/kg/week) for  3 weeks,  the enhancement effect was



reversed,  and suppression  of the CD4+CDw29+ subset was observed,  with maximum




suppression after 6 weeks of exposure to the higher dose.   In  addition, the CD8+




CD56 +  T cytotoxic  T  cell subset was transiently increased,  but which normalized




even  though  TCDD  dosing  continued.    After discontinuation  of  dosing, the



reduction  in the percentage and  absolute  number of  CD4 + CDw29 +  cells persisted




for 5 weeks, reaching normal range 7 weeks later.   These results  led the  authors'



to conclude that "extrapolations of the  results obtained at higher doses to very



low exposures is not justified  with respect to the  effects  induced by TCDD on the



immune system of marmosets."



     The  immunomodulatory  effects  of  chronic low  level  PCB exposure in monkeys



has  also  been  investigated.   In early  studies, Thomas  and  Hinsdill  (1978)



reported that rhesus monkeys fed diets containing  2.5 or 5 mg/kg of Aroclor 1248



had  significantly  suppressed antibody response to  SRBC but not to tetanus toxoid



 (TT).   These monkeys also  had  chloracne, alopecia and facial edema.  Similarly,



exposure  of cynomolgus  monkeys  to Aroclor 1254  (100  or  400 pg/kg/day)  for  3



months suppressed  antibody responses to SRBC but not TT (Truelove et al., 1982).
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                          DRAFT—DO NOT QUOTE OR CITE

Suppressive effects on antiSRBC responses were more severe in cynomolgus monkeys
when the PCB mixture contained PCDFs (Hori et al., 1982).
     Tryphonas et al. (1989; 1991a,b) have recently reported results of studies
in rhesus monkeys exposed chronically to Aroclor 1254 (5-80 pg/kg/day)  for 23 or
55 months.  These exposures resulted in  steady state blood PCB levels that  ranged
from  a mean  low of 0.01±0.001 ppm  in the  5  /jg/kg group to a  mean high of
0.11*0.01  ppm in the  80 pg/kg group.   The only  consistently altered  immune
parameter  was the primary and anamnestic  antibody  responses to SRBC which were
suppressed in a dose-dependent  manner.   In contrast, the  antibody response to
pneumococcus  vaccine  antigen  measured  at  55  months  of  exposure  was  not
 significantly altered.  At 23 months,  the percentage of T helper cells  in the
 blood was significantly  decreased in the 80 pg/kg group, and the percentage and
 absolute number of T suppressor cells was  increased; however, these effects were
 not apparent  at  55 months of exposure (Tryphonas, et al., 1991b).  Lymphoprolif-
 erative responses to PHA and Con A were not significantly altered at 23 months
 but were dose-dependently suppressed at 55 months.  Proliferation to alloantigens
 was not significantly altered. Likewise, serum immunoglobulin and hydrocortisone
 levels did not differ between treatment groups.  After 55 months, the chemilumin-
 escent  response (time to peak)  of monocytes was  slower in  PCB exposed cells.
 Also noted at 55 months was a significant elevation in serum hemolytic complement
 levels, a dose-related  increase in natural killer cell activity,  and a dose-
 related increase in  thymosin  alpha-1 levels  but not  thymosin  beta-4 levels
  (Tryphonas et al., 1991a).  Effects on interferon levels were  inconsistent, and
 TNF  production  was  not  altered.
       The  studies in nonhuman primates  are important from the standpoint that the
  antibody response to SRBC emerges as the only immunological  parameter  consis-
  tently suppressed by  HAH in  several different animal species.   Other immunolog-
  ical endpoints such  as total  T cell numbers,  percentages  of T  cell  subsets,
  lymphoproliferative responses, and DTH responses are inconsistently increased or
  decreased in various studies.   At the present time,  it is  not  clear  why  the
  antibody  response  to  SRBC  is  most  consistently altered by HAH exposure  in
  different species.   The sensitivity of the antiSRBC response  does not appear to
  be due solely to the T-cell dependency of the response  since  antibody responses
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to other  T-dependent antigen  (e.g.,  TT,  BGG)  are  not  suppressed and  may be



enhanced following HAH exposure.   It  is possible that the particulate nature of



the SRBC antigens  is an important factor even though a mechanistic basis for this



is not readily apparent.  The sensitivity  of the technique used to quantify the



antibody response may also contribute to apparent increased sensitivity of the



SRBC model, which is most often measured as the PFC response rather than serum



antibody titers which are usually more variable.  Nonetheless, the finding that



the SRBC response is also suppressed  in nonhuman primates exposed to PCB lends



support to the use of the antiSRBC data  generated in mice to calculate TEFs for




immunotoxicity.



4.12.  IMMUNOTOXICITY OF HAH  IN HUMANS



     The  immunotoxicity of TCDD and  related HAH in  humans has been the  subject



of several studies derived from accidental and/or occupational exposures to PCBs,



PBBs,  and TCDD.   Immunological  assessment  was carried  out on  patients who



consumed  acnegenic  and hepatotoxic doses of PCDF-PCB contaminated rice oil  in



Taiwan in 1979.  Clinical symptoms were primarily related to increased frequency



of various kinds  of  infection, especially of the respiratory tract and skin (Lu



and Wu, 1985).  Immunologic effects included decreased serum IgA and IgM but not



IgG, decreased percentage of T cells  in blood related to decreased CD4+ T helper




cells and increased  CD8+ T suppressor cells, and suppressed dermal delayed type




hypersensitivity responses   to   streptokinase/-streptodornase  and  tuberculin



antigens (Lu and Wu, 1985).  The percentage of anergic patients increased and the



degree  of induration decreased with  increased PCB  concentration  in  the blood.



 In contrast, lymphoproliterative  responses of PEL to PHA, PWM and tuberculin but



 not Con A were significantly  augmented in PCB-exposed patients.  PCB concentra-



 tions in the blood ranged from 3-1156 ppb  with a mean of 89±6.9 ppb.  The oil was



 contaminated at PCB concentrations of 4.8-204.9 ppm with a mean of 52±39 ppm.



      Immunotoxic effects were also described in Michigan dairy farmers exposed



 to PBBs via contaminated dairy products and meat in 1973 (Bekesi et al., 1979).



 Like PCB-exposed patients,  the  percentage and absolute numbers  of  T cells in



 peripheral blood of PBB-exposed  farmers were significantly reduced compared to



 a control group.  However,  in contrast to PCB, lymphoproliferation responses to
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PHA, PWM and allogeneic leukocytes were significantly decreased in PBB exposed
persons.  Also in contrast to PCB, skin testing using standard recall antigens
indicated that PBB-exposed Michigan  dairy  farmers had significantly increased
responses, particularly to Candida and varidase.   Tissue levels of PBB in the
subjects were not determined in these studies.
     Webb et al. (1989) reported the  findings  from immunologic  assessment of 41
persons  from Missouri  with documented adipose tissue levels of TCDD resulting
from occupational, recreational or residential exposure.  Of the participants,
16 had tissue TCDD levels  <20 ppt, 13 had levels between  20 and 60 ppt and 12 had
levels >60 ppt.  The highest level was 750 ppt.  Data were analyzed by multiple
regression  based on  adipose  tissue level and the  clinical  dependent variable.
Increased TCDD levels were correlated with an increased percentage and total
number of T lymphocytes. CD8+ and T11+ T cells accounted for the increase, while
CD4 + T cells  were  not  altered  in  percent  or  number.   Lymphoproliferative
responses to  Con A,  PHA,  PWM or  tetanus toxoid were unaltered  as  was the
cytotoxic T cell response.  Serum IgA  but not IgG was  increased.   No  adverse
clinical disease was associated with TCDD levels in these  subjects.  Only 2  of
the 41 subjects  reported a  history  of chloracne.  These findings  differ  from
 those reported  for  the  Quail  Run Mobile  Home  Park residents  (tissue  levels
 unknown) in which decreased T cell numbers  (T3, CD4 and Til)  and suppressed cell-
 mediated immunity was reported  (Hoffman  et  al., 1986).   However, subsequent
 retesting of these anergic subjects  failed to confirm the anergy (Evans et al.,
 1988).  On the other hand, when serum from some of these individuals was tested
 for  levels of  the thymic  peptide,  thymosin alpha-1,  the  entire frequency
 distribution for the TCDD-exposed group was shifted toward lower thymosin alpha-1
 levels  (Stehr-Green et al., 1989).  The statistically significant difference
 between the TCDD-exposed  persons  and controls remained after controlling for age,
 sex, and socioeconomic status, with a trend of decreasing thymosin alpha-1 levels
 with increasing number of years of residence in the TCDD-contaminated residential
 area.   The thymosin  alpha-1 levels  were  not correlated with changes in other
 immune system parameters nor with any increased incidence of clinically diagnosed
 immune suppression.   The decrease in thymosin alpha-1 levels in humans contrasts
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with the increase in thymosin alpha-1 seen  in  PCB treated monkeys (Tryphonas et



al., 1991b).



     Finally, Mocarelli et al. (1986) reported studies on the immune status of



44 children, 20 of  whom  had  chloracne,  that were  exposed to TCDD following an



explosion at a herbicide factory in Seveso, Italy.  No abnormalities were found



in the  following  parameters:  serum immunoglobulin  concentrations,  levels of



circulating  complement,   or  lymphoproliterative  responses  to  T  and  B  cell



mitogens.   Interestingly,  in a  study conducted 6  years after the explosion, a



different cohort  of TCDD-exposed  children  exhibited a significant increase in



complement protein  levels, which correlated with the incidence of chloracne, as



well  as  increased   numbers  of peripheral blood  lymphocytes,   and  increased



lymphoproliterative responses  (Tognoni and  Bonaccorsi,  1982).   However, no



specific health problems were correlated with dioxin exposure in  these children.



     It  is  readily  apparent that  no  clear pattern of  immunotoxicity to  HAH



emerges from these studies in humans.  In some cases T cell numbers  increase; in



others,  they decrease.    The  findings are not unlike  the  varied  and often



conflicting reports found in the  literature regarding  animal  studies of  HAH



immunotoxicity.   The basis  for the lack  of consistent, significant exposure-



related effects is unknown and may be dependent on several factors.  Most notable



in this regard is  the generic difficulties in assessing subclinical immunomodula-



tion, particularly  in outbred human populations.  Most immunological assays  have



a very broad range  of normal responses reducing the sensitivity  to  detect small



changes.  Similarly, the assays used to examine immune function in humans exposed



to TCDD and related HAH have  unfortunately been based to a greater extent on  what



was clinically "doable" (e.g., mitogen responsiveness) rather than on assays  that



have  been shown to be sensitive to TCDD in animal studies.   Thus, the lack of



consistent  and/or significant immunotoxic effects in humans resulting from  TCDD



exposure may be as much a function of the assays used as the  immune status of the



cohort.  In addition, few studies  have examined the immune status of individuals



with known, documented exposure to HAH. Rather, cohorts based on presumption of



exposure  have  been  studied.  There  is some evidence to suggest that the lack of



consistent, significant effects may sometimes  be due to the inclusion of subjects



that had little or no actual  exposure to TCDD (Webb et al., 1989).  Likewise, the




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important role  that Ah phenotype  plays  in TCDD  immunotoxicity has not  been
conaidered  when  addressing  human  sensitivity.    Whether  there  are  human
equivalents of  murine Ahbb  and  Ahdd types is  not known.   Finally,  in  most
studies, the assessment of immune function in exposed populations was carried out
long after exposure to TCDD  ceased.  Thus, recovery from the immunotoxic effects
of TCDD may have occurred.
     in  summary,  one might  speculate  that any future  study  to determine HAH
immunotoxicity  in  humans  should  evaluate their  antibody  response  to SRBC.
However,  it should be emphasized that even the relatively low  exposure levels
that  have been shown  to  suppress the antiSRBC  response in nonhuman  primates
resulted in blood  and tissue PCB or  TCDD levels that  far  exceed the levels
measured in humans in most studies  published to date  involving  environmental
exposure.  Thus,  even the  antiSRBC response may  not  have been sensitive enough
to demonstrate  immune suppression in these cohorts.   Given  the current lack of
data correlating  clinical  immunological  endpoints with immune status in humans
 (except in cases of overt immune deficiencies), massive retrospective studies of
 poorly defined  exposure groups cannot be justified to try to "prove" that immune
 modulation has occurred in these people.  Rather, such efforts would be better
 directed toward the establishment of a broad  data base of normal values for the
 clinical immunology endpoints that may be  of use  in immunotoxicity assessments.
 in  conjunction with  this  effort,  research  must focus  on the  definition of
 sensitive endpoints (i.e., biomarkers) of immune dysfunction  in humans so that,
 in  the future, emergency  response  teams could  respond  rapidly  to accidental
 exposures to assess the immunological status of the exposed persons.  To validate
 these biomarkers, there is a parallel  need for animal research to  identify TCDD-
 sensitive  immune endpoints in animals  that  can  also be measured in humans  in
 order to establish in correlative changes in the biomarker  and immune  function.
 in particular,  it  will  be  important to  determine  in  animal models how  well
 changes in immune function in the  lymphoid organs  (e.g., spleen,  lymph  nodes)
  correlate with changes in the expression of lymphocyte subset/activation markers
  in peripheral blood.  Until such correlations are established, the interpretation
  of changes  observed in subsets/activation  markers  in  human  peripheral  blood
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lymphocytes in terms of health risk will  be limited to speculation.  Research



must also continue to develop well-defined animal models using multiple animal



species that will lead to an understanding of the underlying mechanisms of HAH



immunotoxicity.   For  example,  there is a clear  need to  document  Ah receptor



involvement in the immunotoxicity of TCDD  and related HAH  in species other than



mice.  These studies need to go beyond descriptive immunotoxicity assessment to



determine the mechanistic basis for differences in species sensitivity to TCDD



immunotoxicity following both acute and chronic exposure.  In the interim, the



available  data  base  derived  from well-controlled   animal  studies  on  HAH



immunotoxicity can be used for establishment of no effect  levels and acceptable



exposure levels for human risk assessment  of TCDD using the same procedures that



are  used for  other noncarcinogenic  toxic endpoints.    Because  the antibody



response to SRBC  has  been  shown  to be dose-dependently suppressed by TCDD and



related HAH in several animal species, this data base is best suited for current



application to risk assessment.  The validity of  using TEFs to extrapolate from



one  HAH to another, however, remains to be  established.



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Ackermann, M.F., T.A.  Gasiewicz, K.R. Lamm, D.R. Germolec and M.I. Luster.  1989.



Selective  inhibition  of  polymorphonuclear neutrophil  activity  by 2,3,7,8-



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Alsharif,  N.Z.,  T.  Lawson  and S.J.  Stohs.   1990.   TCDD-induced production  of



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Bekesi,  J.G.,  H.A.  Anderson, J.P.  Roboz  et al.  1979.  Immunologic dysfunction



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Benjamin!, E.  and S. LeskowitzS.    1991.  Immunology;  A Short  Course,  2nd ed.
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Birnbaum, L.S., M.M. McDonald,  P.C.  Blair, A.M.  Clark,  and  M.W.  Harris.   1990.
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 Blaylock, B.  L.,  S.D.  Holladay,  C.E. Comment,  J.J.  Heindel  and M.I.  Luster.
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 Braley-Mullen, H.  1982.   Differential effect  of activated  T amplifier cells on
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Clark, G.C., M.J. Taylor, A.M. Tritscher and G.W. Lucier.  1991b.  Tumor necrosis



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Cuthill,  S.,  A.  Wilhelmsson,  G.G.F. Mason,  M.  Gillner,  L.  Poellinger  and



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coid  receptor.  J. Steroid Biochem.   30:  277-280.







Davis,  D.  and  S. Safe.   1988.   Immunosuppressive  activities  of polychlorinated



dibenzofuran  congeners:   quantitative  structure-activity  relationships  and



interactive effects.   Toxicol.  Appl.  Pharmacol.   94:  141-149.







Davis,  D. and  S.  Safe.   1989.   Dose-response immunotoxicities  of commercial



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dibenzo-p-dioxin.   Toxicol. Lett.  48: 35-43.







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 dependent on the Ah receptor.  Immunopharmacology.   21: 183-190.
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DeKrey, G.K., L.B. Steppan, J.A. Deyo and N.I. Kerkvliet.  1990.  Adrenalectomy
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DeKrey, G.K., J.A. Deyo and N.I. Kerkvliet.  1992.  Castration  (ODX) partially
alleviates  the  suppression  of  cytotoxic  T   lymphocyte  (CTL)   activity  by
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 Dooley, R.K.  and M.P.  Holsapple.    1988.   Elucidation of cellular  targets
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 antibody responses:  the  role of the B  lymphocyte.   Immunopharmacology.   16:
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 Dooley, R.K., D.L.  Morris and M.P.  Holsapple.   1990.   Elucidation of cellular
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 Evans, R.G., K.B. Webb, A.P.  Knutsen et al.  1988.  A medical  follow-up of the
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 Faith, R.E. and J.A. Moore.   1977.   Impairment  of  thymus-dependent immune
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Faith, R.E., M.I. Luster and J.A.  Moore.  1978.  Chemical separation of helper



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Fine, J.S., T.A. Gasiewicz  and  A.E.  Silverstone.  1989.   Lymphocyte stem cell



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Mol. Pharmacol.  35: 18-25.







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action  of  2,3,7,8-tetrachlorodibenzo-p-dioxin  (TCDD)  on  thymic  epithelium.



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Hinsdill,  R.D.,  D.L.  Couch and R.S. Speirs.   1980.   Immunosuppression in mice



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xenobiotics on serum tumor necrosis  factor (TNF) and interleukin-6  (IL-6) release



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Holladay, S.D., P.  Lindstrom,  B.L. Blaylock.  1991.  Perinatal thymocyte antigen
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Holsapple, M.P.,  R.K. Dooley, P.J.  McNerney  and J.A. McCay.   1986a.  Direct
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Jelinek,  D.F.  and  P.E.  Lipsky.   1987.    Regulation of  human  B  lymphocyte



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Kerkvliet,  N.I.  and  L. Baecher-Steppan.   1988a.    Suppression  of allograft



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