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  EPA/600/AP-92/001C
         August 1992
Workshop Review Draft
        Chapter 3.  Acute, Subchronic, and Chronic Toxicity
                                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 recomnjendation
                                                                                  I
for use.                                                                           i
           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
           a peer-review workshop.  It will be revised subsequent to the workshop as
           suggestions and contributions from the scientific community are incorporated.
at
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                                     CONTENTS


Tables  	iv

List of Abbreviations	v

Authors and Contributors	.-	x


3. ACUTE, SUBCHRONIC AND CHRONIC TOXICITY	  3-1

   3.1. SCOPE AND LIMITATIONS  	  3-1
   3.2. ACUTE TOXICITY	  3-1

       3.2.1.  Signs and Symptoms of Toxicity	  3-5
       3.2.2.  Studies In Vitro	  3-8
       3.2.3.  Appraisal	  3-9

   3.3. SUBCHRONIC TOXICITY	  3-9

        3.3.1.   Appraisal	•	 3-10

   3.4.  CHRONIC TOXICITY	3-11

        3.4.1.   Appraisal	 3-13

   3.5.  SPECIFIC EFFECTS	 3-13

        3.5.1.   Wasting syndrome	 3-13
        3.5.2.   Hepatotoxicity	 3-17
        3.5.3.   Epidermal Effects	 3-20
        3.5.4.   Enzyme induction	 3-21
        3.5.6.   Endocrine Effects	 3-25
        3.5.7.   Vitamin A Storage	 3-28
        3.5.8.   Lipid Peroxidation	 3-31

   3.6.  MECHANISMS OF TOXICITY .	 3-31
   3.7.  CONCLUSIONS	 3-34
   3.8.  REFERENCES	 3-36
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                                   LIST OF TABLES
3.1

3.2


3.3


3-4
Acute Lethality of TCDD to Various Species and Substrains

Toxic Responses Following Exposure to 2,3,7,8-TCDD:
Species Differences	
Studies on Chronic Exposure (Except for Studies on Cancer)
to TCDD in Laboratory Animals  	
Lowest Effect Levels for Biological Responses of 2,3,7,8-TCDD
in Experimental Animals	
                                                                                     3-2
 3-6
3-12
                                                                                    3-35
                                             IV
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ACTH




Ah




AHH




ALT




AST




BDD




BDF




BCF




BGG




bw




cAMP




CDD




cDNA




CDF




CNS




CTL




 DCDD




 DHT




 DMBA




 DMSO




 DNA




 DRE
             LIST OF ABBREVIATIONS






Adrenocorticotrophic hormone




Aryl hydrocarbon
                                       a



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




 Dimethylbenzanthracene




 Dimethyl sulfoxide




 Deoxyribonucleic acid




 Dioxin-responsive enhancers
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DTG




DTK
ECOD




EOF




EGFR




ER




EROD




EOF




FSH




GC-ECD




GC/MS




 GGT




 GnRH




 GST




 HVH




 HAH




 HCDD




 HDL




 HxCB




 HpCDD
         LIST OF ABBREVIATIONS (cont.)








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-Ethoxyresurofm 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
Heptachlorinated dibenzofuran




High performance liquid chromatography



High resolution gas chromatography/high resolution mass spectrometry




Hexachlorinated dibenzo-p-dioxin




Hexachlorinated dibenzofuran
I-TEF
LH




LDL




LPL




LOAEL




LOEL




MCDF




MFO




 mRNA




 MNNG




 NADP




 NADPH




 NK




 NOAEL
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




/V-methyl-N-nitrosoguanidine




Nicotinamide adenine dinucleotide phosphate




 Nicotinamide adenine dinucleotide phosphate (reduced form)




 Natural killer



 No-observable-adverse-effect level
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NOEL




OCDD




OCDF




PAH




PB-Pk




PCB




OVX




PBL




PCQ




PeCDD




PcCDF




 PEPCK




 PGT




 PHA




 PWM




 ppm




 ppq




 ppt




 RNA




  SAR




  SCOT
          LIST OF ABBREVIATIONS (cont.)








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




t*



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



TetracWoroazoxybenzene




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
                                            IX
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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, wijth Carol
Haynes, Environmental Criteria and Assessment Office in Cincinnati, OH, serving as Projept Officer.
       During the preparation of this chapter, EPA staff scientists provided reviews of the! drafts as
well as coordinating internal and external reviews.

AUTHORS
Ulf G. Ahlborg
Karolinska Institute
Stockholm, Sweden

EPA CHAPTER MANAGER
Debdas Mukerjee
Office of Health and Environmental Assessment
Environmental Criteria and Assessment Office
Cincinnati, OH
                                                                                   08/11/92

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                  3.  ACUTE,  SUBCHRONIC AND CHRONIC TOXICITY
3.1.   SCOPE AND LIMITATIONS
     The acute, subchronic and chronic  toxicology  of  the chlorinated dioxins,
dibenzofurans, biphenyl and related compounds has been reviewed extensively in
recent years  [CDDs and CDFs, WHO/IPCS  (1989), U.S.  EPA (1984,  1985); PCBs and
PCTs, WHO/IPCS (1991); U.S. EPA (1990);  PCBs, U.S. EPA (1990); and BDDs and BDFs,
U.S. EPA (1991)].  This  chapter  is intended  to  summarize our knowledge of the
toxicology of  TCDD  in  the main,  but includes references to other dioxin-like
compounds when relevant data are  available.   The chapter does  not have the
intention to reference  all published material but rather seeks to select various
data that are considered to  be of  importance to risk assessment.   The chapter
covers  experimental  animal  data.   Immunotoxicity, reproductive/developmental
toxicity, carcinogenicity, toxicity to  humans and epidemiology will all be dealt
with in separate chapters, nor will ecotoxicology be covered in this chapter.
3.2.   ACUTE  TOXICIXY
     The range of doses  of TCDD  which  are  lethal to animals varies extensively
both  with species  and  strain,  as well  as with  sex,  age  and  the route of
administration within a single strain (Table 3-1).  Typically there is a delayed
toxicity, with the  time to death after exposure, usually being several weeks.
However, deaths within the first  week after exposure have been observed in guinea
pigs  (Schwetz et al.,  1973), rabbits (Schwetz et al.,  1973) and  Golden Syrian
hamsters  (Olson et al., 1980).  More than an 8000-fold difference exists between
the dose of TCDD reported to  cause 50% lethality in  male Hartley guinea pigs, the
most sensitive species tested (Schwetz et  al., 1973), and the corresponding dose
 in male  Syrian Golden  hamsters (Henck et  al.,  1981).   Another animal  with
 extremely high sensitivity is the mink (Wustela vision) and for  the male an LD50
 value of  only 4.2 /ug/kg has been calculated (Hochstein et al.,  1988).
      Among traditional experimental animals, the rat seems to be the second most
 sensitive species,  although there is  a  >300-fold variability in  LD5Q  values
 between different strains.   The  Han/Wistar (Kupio)  strain of rat has been shown
 to be particularly  resistant to  TCDD exposure (Pohjanvirta and Tuomisto,  1987).
                                       3-1
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                                                                     of other
Among the five rats per dose group (0,  1500,  2000,  2500  or  3000 nq TCtiD/kg bw),
only one animal died within the 39-40 days observation period.  Also,|the DBA/2
                                                                     I
male mouse has been shown to have a high resistance to TCDD toxicity (Chapman and
                                                                     i
Schiller, 1985).                                                     j
     Data on  sex-differences in sensitivity to the lethal effects ofj TCDD are
conflicting.  Acute toxicity data which addresses the effect of age at!the point
of exposure to TCDD are  scarce,  and  comparisons are hampered by  the  absence  of
or the inadequacy of the information on the age and/or body weight of fhe tested
animals.  Additionally, as demonstrated with  other chemicals, the acutJ3 toxicity
may  vary several-fold,  depending on  vehicle used  or  the presence
substances that  affect uptake.
      The differences in sensitivity towards TCDD  among  various  strains  of mice
have been claimed to depend  on a  genetic  variability in the  Ah  Ifocus  (see
Chapter 2).                                                          |
      In two  strains of male C57B/6J  mice that differ only  at the JAh locus,
Birnbaura et  al.  (1990) found LD50 values  of 159 and 3351 pig/kg for the| wild-type
mice (Ahb/b)  and the congenic mice (Ahd/d), respectively. The mean tittje to death
was 22 days  and was independent of  dose and genotype.   Signs of toxicity were
 similar in the two  strains, and it was concluded that the spectrum o;f toxicity
 is independent of the allele at  the Ah locus.  However,  the relative dose needed
 to bring about various  acute responses  is -8-24 times  greater in congenic mice
 homozygous for the "d" allele than for the wild-type mice carrying two copies of
 the  "b- gene.                                                       I
      In contrast,  the two  strains of rats studied by Pohjanvirta et  al. (1988)
  [i.e., Long-Evans and Han/Wistar (Kuopio)] had intraperitoneal LD50 values of 10
  and >3000 ng TCDD/kg,  although no differences  as  regards the amojint or  the
affinity of available Ah receptor could be found.
     Geyer et al. (1990) utilized both their own and other data to determine a
correlation between  total  body fat content and  the  acute  toxicity
species and strains  of  laboratory mammals.   However, data from the
                                                                      in  various
                                                                      Han/Wistar
 (Kuopio) rats that are extremely resistant to TCDD-induced lethality (Pohjanvirta
 and Tuomisto,  1987)  were not included.   They found a correlation of 0.834 and
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suggested that the  reasons  for  this correlation is obvious  that  an increased
total body fat content represents an enhanced capacity to remove TCDD from the
systemic circulation.   This factor may be important, but  it almost certainly
doesn't explain all the interspecies differences.
     In chickens,  acute toxicity is  characterized by clinical signs  such as
dyspnea, reduced body weight gain, stunted growth, subcutaneous edema, pallor and
sudden death (chick edema disease).  The disease first gained  attention in 1957,
but the causal agents were not identified as CDDs until much later  (Firestone,
1973).  Chick edema occurred in birds given oral doses of 1 or 10 jjg  TCDD/kg/day
or of 10 and 100 pg hexaCDD/kg/day, but it was not  observed in chicks maintained
on a diet containing 0.1 or  0.5% OCDD  (Schwetz et  al., 1973).
3.2.1.   Signs and Symptoms of Toxicity.  TCDD affects  a variety of organ systems
in different species.  It should be noted that much of the comparative data base
is derived from high-dose effects.  The liver is the organ primarily affected in
rodents and  rabbits, while  in guinea  pigs, atrophy of the  thymus  and lymphatic
tissues seems to be most sensitive markers of toxicity  (WHO/IPCS, 1989; U.S. EPA,
1984,  1985).  It  is not possible  to  specify a single organ whose  dysfunction
accounts  for the  lethality.   Dermal effects are prominent  signs of  toxicity in
subhuman  primates, and changes  in epithelial  tissues  dominate both cutaneously
and internally.   This  is most apparent in nonhuman primates,  and  the cutaneous
 lesions closely mimic  the chloracne and  hyperkeratosis observed in humans.   The
histopathological alterations observed in epithelial tissues include hyperplastic
 and/or metaplastic  alterations, as well as  hypoplastic responses.  The  toxic
 responses of various  species to TCDD are  summarized in  Table 3-2 (WHO/IPCS,
 1989).
      Loss of body weight (wasting syndrome) is a characteristic sign observed in
 most animals given a  lethal dose of TCDD.  The weight  loss usually manifests
 itself within a few days after exposure and results in a substantial reduction
 of the adipose tissue (Peterson et al.,  1984)  and  of  the muscle tissue (Max and
 Silbergeld, 1987)  observed  at  autopsy.   With sublethal  doses of  TCDD,  a dose-
 dependent decrease  in body weight gain  occurs.
      The greatest species-specific differences in  toxicity concern  pathological
 alterations in the  liver.  Lethal doses to guinea pigs do not result in liver
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damage, which IB comparable to the liver lesions described in rabbits and rats,
or to  liver  changes  observed in mice (McConnell et al.,  1978b;  Moore et al.,
1979; Turner and Collins,  1983).  In  the hamster, manifest liver lesions do not
occur even after fatal doses; however,  the ED^Q for increased hepatic weight is
only -15 ug/kg  (Gasiewicz  et al.,  1986).  Liver  related enzyme activities in
serum are elevated in those animal species where liver damage is a prominent sign
of TCDD  toxicity.   In those animal species where  hepatotoxicity is  not as
apparent, such  as  monkeys  and guinea pigs, these  enzyme activities are nearly
normal.
     Thymic atrophy has also been found in all animal species given  lethal doses
of TCDD.  Treatment of animals with TCDD  inhibits the bone marrow hematopoiesis
in mice,  both in  vivo and in vitro,  by directly altering the colony growth
efficiently  of  stem  cells  (Chastain  and  Pazdernik,  1985; Luster et al., 1980,
1985).
     Among  other  signs and symptoms that  have  been demonstrated in various
species,  the following should  be noted:   hepatic porphyria,  hemorrhages in
various  organs,  testicular atrophy,  reduced prostate weight, reduced uterine
weight, increased  thyroid weight, lesions of the adrenal glands,  inhibited bone
marrow hematopoiesis, decreased serum albumin and  increased  serum triglycerides
and free fatty acids).  Details of all underlying studies for these  observations
have been extensively  reviewed  (U.S. EPA,  1984, 1985; WHO/IPCS,  1989).
     Effects on heart muscle have also been observed in guinea pigs and rats
 (Brewster et al.,  1987; Kelling et  al.,  1987;  Canga et al., 1988).  Five days
after  a single dose  of  TCDD  (10  jug/kg  intraperitoneally).  a significantly
decreased beta-adrenergic  responsiveness  was observed in the  right ventricular
papillary muscle of guinea pig (Canga et al.,  1988).  In the TCDD-treated animals
a decrease in the positive  inotropic effects of isoproterenol at 0.03-0.3 pM, but
not  at 0.1-10 nM. was also demonstrated.  Additionally, the  responsiveness to
low-frequency stimulation and to increases in extracellular calcium were enhanced
in these animals.  Based on these findings, the authors suggested that  the heart
may  be a major  target for  TCDD toxicity.
                                      3-7
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     In the monkey,  several  additional  symptoms  have been registeredj, such as
periorbital  edema,  conjunctivitis  and  thickening of  the Meibomiarj glands,
followed by  loss of the  eyelashes,  facial hair and  nails  (McConnelj et al.,
1978a).  These are symptoms  similar to those which have been observed in cases
of human intoxications (e.g., occupational  exposure, the Seveso incident  and the
Yusho and Yu-Cheng toxic oil  intoxications (the latter  involving exposure to PCBs
and CDFa;  see  chapter 1)
                                                                     I
3.2.2.    Studies In Vitro.   Over 30  cell  types,  including  primary  cultures  and
cello  from established and transformed cell lines  derived  from various  tissues
of  at  least six animal species, have been  examined  for their  general cellular
responses to TCDD (Beatty et al., 1975; Knutson and Poland, 1980a;  Hijra  et al.,
1975;  Yang et al., 1983a).  The effects studied were changes in viability, growth
rate and morphology.  Overall,  there have been few or no effects documented.
      However, other in vitro studies using more specific endpoints ojE toxicity
                                                                     I
have clearly indicated effects of TCDD at comparatively low  concentrations. Thus,
 several  studies  have  shown that TCDD  affects cultured epidermal keratinocytes
 through interactions with differentiation mechanisms and that this  effect may be
 regulated  by the modulation of EOF binding to the cells (Hudson et ajl., 1986).
 Additionally, in epithelial cells of human origin, TCDD has been shown to alter
 differentiation (Hudson et al., 1985)  and AHH EROD activity has been jhown to be
 induced  in vitro (see Section  3.5.4).
       Wiebel et  al.   (1991) have  identified  a  cell  line (H4IIEC3-derived 5L
r
 hepatoma cells)  which  responds  with decreased  proliferation  at|  low TCDD
 concentrations.   Thus,  half-maximum inhibition of  proliferation  occurs at  a
 concentration of 0.1-0.3  nM, and the onset  of  the effect  is faijrly  rapid,
 manifesting itself  as early as 4-8 hours after treatment.  Further  sjudies have
 also demonstrated that insensitive variants of this cell line were  deficient in
  cytochrome  P-4501A1  activity and also lacked  measurable amounts j of the  Ah
  receptor (GBttlicher et al., 1990).  In addition,  3,3',4,4'-TCB also inhibited
  proliferation in the sensitive cell-line,  albeit at higher concentrations.
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3.2.3.   Appraisal.  The numerous studies of acute toxicity in various species



have demonstrated dramatic species- and  strain-specific  differences  in sensi-



tivity.   However,  the spectrum of symptom is in general  agreement,  although



species differences exist.



     Lethality is typically delayed by several weeks, and there is a pronounced



wasting syndrome  in  almost all  laboratory animals.  Studies  in  congenic mice



differing  in  their Ah responsiveness  indicate  that the sensitivity  to acute



toxicity of TCDD  segregates with  the  Ah  locus.   Furthermore,  studies on other



CDDs, CDFs and coplanar PCBs demonstrate that the potency  for inducing lethality



correlates with their ability to bind to  the Ah receptor.  In contrast, studies



in  various  other species,  as  well  as  in  various  strains of  rats,  have



demonstrated a wide range of sensitivities regardless of rather  comparable levels




of the Ah  receptor.



3.3.   SUBCHRONIC TOXICITY



     The available studies on the  subchronic toxicity of TCDD have been reviewed



by  the U.S.  EPA (1984,  1985)  and WHO/IPCS  (1989).   Overall,  the  signs and



symptoms  observed  are in agreement with  those observed after  administration of



single doses.



      The  study of Kociba et al.  (1976) is of special interest as it has been used



for  comparisons  of the relative toxicities of other CDDs/CDFs (Pliiess et al.,



1988).  Adult male and female Sprzigue-Dawley rats, in groups  of  12, were  given



0,  0.001,  0.01,  0.1  and 1.0 fig TCDD/kg bw by gavage 5 days/week for 13 weeks.



At  the end of the treatment period,  five rats of each sex were  sacrificed  for



histopathological examination.  The  remaining animals were  continued for  post-



exposure  observation.  The highest dose caused five deaths among  the  females,



three during the treatment period and two after, while two deaths occurred in



males in  the  post-treatment  period.   The rats  given  0.01 ^ig TCDD/kg did  not



differ from the  controls except for a slight increase in  the mean liver-to-body



weight ratio.



      A 13-week  dietary study  in Sprague-Dawley  rats given  1,2,3,4,8-PeCDF,



 1,2,3,7,8-PeCDF,  2,3,4,7,8-PeCDF or  1,2,3,6,7,8-HxCDF  demonstrated that  the



 subchronic toxicity and the depletion of hepatic vitamin A reduction followed the



 rank order of the ability of the compounds to bind to the Ah  receptor or cause




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                          DRAFT—DO NOT  QUOTE OR  CITE

induction of AHH,  for example (Pliiess et al., 1988;  Hakansson et al.f 1990).
However, the direct comparisons of the effects are hampered by the differences
in toxicokinetic behavior of  the  compounds.   Slightly different relationships
                                                                     I
with  regard  to toxicity  were obtained in a  tumor promotion  study, j where an
initial loading dose  (aubcutaneous)  of  2,3,4,7,8-PeCDF was given, followed by
repeated lower doses (subcutaneous) in order to obtain a steady-state concentra-
tion  (Warn et al.,  1991a).  However, both of these studies support the assumption
that  most signs and symptoms  obtained may be mediated through  the Ah!receptor.
      In another atudy,  groups of  eight  female  Sprague-Dawley rata wete exposed
to 16 weekly oral  doses of 0,  0.01, 0.1, 1.0 and 10.0 /ig TCDD/kg bw iji a  study
primarily aimed at investigating TCDD-induced porphyria (Goldatein et al., 1982).
The  no-effect dose for porphyria  was 0.01 jig/kg/week.
      Only  two atudies of limited value have been performed in mice  ([Harris et
 al.,  1973; Voa et al., 1973).  Four weekly oral doses of 0.2, 1, 5  or  25 pg
 TCDD/kg bw were given to male C57B1/6 mice  in corn oil.  No effects were noted
 at 1 ng, which corresponds to -0.1 pg/kg bw/day.
      In male and female Hartley guinea  pigs, a 90-day feeding  study ojf TCDD has
 been performed by DeCaprio et al. (1986) where extenaive pathology, ihematology
 and serum chemistry on aurviving animala were performed.  The dieta contained 0,
 2, 10, 76  or 430 ng TCDD/kg.  The two loweat doaea,  2  and 10 ng/kp of diet,
 produced no dose-related alteration.  Baaed on  thia  atudy a no-observed-effeet
 level of  0.6  ng  TCDD/kg bw/day in guinea piga  was  eatimated.  At tjhe highest
 dose, severe  body weight losaea  and mortality were obaerved.    No dcjae-related
 mortality occurred at  76 ng/kg.                                     j
      A cumulative doae of 0.2 jig TCDD/kg bw,  which waa  divided into  nine  oral
signs of
Signs of
  doses 3 times/week during days 20-40 of gestation, produced no clinic
  toxicity in pregnant rheaua monkeya  (Macaca mulatta) (McNulty, 1984)
  toxicity such as body weight loss, epidermal changes and anemia occurred in thoae
  monkeys who had received cumulative  doses of 1.0 and 5.0 /jg TCDD/kg bw over the
  same time period.                                                  j
  3.3.1.    Apprmi.ml. Utilizing the  above data, subchronic NOAELs forj rats, mice
  and guinea pigs are  estimated 0.01 pg,  0.1 /jg  and  0.6  ng TCDD/kg  bw/day,
  respectively.    However, these studies cannot be  directly compared;  with each
                                       3-10                             08/11/92

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                         DRAFT	DO NOT QUOTE OR CITE

other. Furthermore, none of the studies have utilized initial loading doses, and
due to the long  half-life  of  TCDD,  steady states may not been reached  in the
animals except  at the very end  of the  study  periods.   Distribution  between
tissues in the animals depends on both time of exposure and the dose levels (see
Chapter 1), which further complicates any comparisons.
     Irrespective of this, the limited data available seem to indicate that signs
and symptoms of subchronic toxicity follow the same rank order as Ah receptor-
mediated effects, such as induction of AHH.
3.4.   CHRONIC TOXICITY
     The results  of chronic toxicity studies  performed  on laboratory animals
exposed to TCDD are summarized in Table  3-3.  Details have been reviewed by the
U.S. EPA (1984, 1985) and WHO/IPCS (1989).
     The most important study in rats  is the  chronic study of  Kociba et al.
 (1978, 1979).  Groups  of 50 male and 50 female Sprague-Dawley rats were fed  diets
providing daily doses of 0.001,  0.01  and 0.1 ng TCDD/kg bw for 2 years.  Control
rats,  86 males  and 86 females  received diets containing the  vehicle alone.
 Increased mortality was observed in females given 0.1 /jg/kg/day, while increased
mortality  was not observed in male rats at this dose,  or in animals receiving
doses of 0.01 or 0.001>g/kg/day.  From month 6  to the end of the study,  the mean
body weights  of males and females decreased at  the highest dose and, to  a lesser
 degree,  in females given 0.01 jug/kg/day.  During the middle of the study, lower-
 than-normal body  weights were also occasionally recorded in the  low-dose group,
 although during the last quarter of the study,  the body weights were  comparable
 to those of  the  controls.
      Increased urinary coproporphyrin and uroporphyrin were noted  in females, but
 not in males, given TCDD at a dose rate of 0.01 and 0.1 fjg/kg/day. Analyses of
 blood serum collected at terminal necropsy revealed increased enzyme activities
 related  to impaired  liver function in  female rats given 0.1 pg TCDD/kg/day.
 Necropsy examination  of the rats surviving TCDD exposure to the end of the study
 revealed  that  liver  effects in  the  liver  constituted  the  most  consistent
 alteration in both males and females.   Histopathological  examination  revealed
 multiple,  degenerative, inflammatory and necrotic changes in the  liver that were
                                      3-11
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      DRAFT—DO NOT QUOTE OR CITE
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                        3-12
                                                                    08/06/92

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                         DRAFT—DO NOT QUOTE OR CITE

more extensive in females.  Multinucleated hepatpcytes and bile-duct hyperplasia
were also noted.  Liver damage was dose-related, and no effect was observable at
the low-dose rate.   The NOAEL was estimated to be 0,001 /ug/kg/day.  At the end
of the study, the fat and liver  concentration of TCDD at this dose was 540 ppt.
     In male Swiss mice, weekly oral doses of 0,  0.007, 0.7 and 7.0 pg TCDD/kg
bw for 1 year resulted in amyloidosis and dermatitis (Toth et al., 1979).  The
incidence of these lesions was  0  of  38,  5 of 44,  10 of 44 and 17 of 43 in the
control-, low-, medium- and high-dose groups, respectively.  The LOAEL in this
study was estimated to be 0.001 pg/kg/day.
     In the NTP  (1980) gavage study  in B6C3F1 male and female mice, no adverse
effects were seen at the lowest dose tested (i.e., 0.01 and 0.04 pg/kg bw/week
for males and females, respectively, corresponding to -1.4 and 6 ng/kg bw/day.
     The limited studies (9-20 months) available in rhesus monkeys (Allen et al.,
1977;  Barsotti et al.,  1979;  Schantz et al.,  1979)  have revealed signs and
symptoms similar to those recorded in more short-term studies.  Adverse effects
were noted down to the lowest dose tested (i.e., -2-3 ng/kg bw/day for  20 months
 (Schantz et  al., 1979).
3.4.1.   Appraisal.   From the different  long-term studies on TCDD, it can be
estimated that the NOAEL  for the  rat is  1 ng/kg bw/day, corresponding to  a fat
and  liver concentration (NOEL)  of 540 ppt.  For the male Swiss mouse, effects
 (dermatitis  and  amyloidosis  in 5 of 44 animals)  were noted at the  lowest dose
tested (i.e., the LOEL would be 1  ng/kg bw/day).  However, in B6C3F1 mice,  NOEL8
of  1.4 and 6 ng/kg/day were  obtained for males and females, respectively. The
 studies in the rhesus monkey cannot  be used  for  such a determination.  Adverse
 effects have been  observed at  the lowest dose tested,  -2-3 ng/kg body weight.
 3.5.    SPECIFIC  EFFECTS
 3.5.1.   Hasting syndroae.   TCDD  at  high  doses (lethal or near lethal) causes a
 starvation-like  or wasting syndrome  in several animal species.  In young animals
 or  following  a  sublethal dose to  adults,  this  response is  manifested as  a
 cessation of  weight gain.   Animals exposed to  near  lethal  or higher  doses
 characteristically lose weight rapidly.  Numerous  studies utilizing pair-feeding,
 total parenteral nutrition and everted  intestinal sacs have  been performed  to
 elucidate the mechanisms  behind the wasting syndrome (U.S.  EPA,  1984,  1985;
                                      3-13                             08/11/92

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                          DRAFT—DO NOT QUOTE  OR CITE
WHO/IPCS,  1989),  but  no single  explanation has  been obtained  so far.   No
generalized impairment of intestinal absorption seems to occur.  PeterJon et al.
(1984) has suggested a model for the TCDD-induced wasting syndrome whiclj is based
on  the assumption  that  body weight in  rats is regulated  around anj  internal
standard  or  a hypothalamically-programmed set point.   Thus,  body weight at a
given  age is  constantly  being  compared to this set point value,  and i|f differ-
ences  occur,  feed consumption is  adjusted.   When  TCDD lowers this set point,
reduction in  food consumption  results as the rat attempts to  reduce its weight
to  a new lower level.   This hypothesis  has  been tested in  several  experiments
under  carefully  controlled  feeding   conditions.    Repeated   studies   have
demonstrated that reduction of  feed intake due to increased food  spillage  is
sufficient to account for the loss of body weight in TCDD-treated Sprague-Dawley
rats.  Additionally, TCDD-treated rats maintain and defend their reduced weight
 level with the same precision as ad libitum fed control rats defend their normal
weight level  (Seefeld and Peterson, 1983,  1984; Seefeld  et al., 198^a,b); the
 percentage of  the daily feed  intake that  is absorbed by the gastrointestinal
 tract of TCDD-treated and control rats  is  similar  (Potter et al., 1986; Seefeld
                                                                     i
 and Peterson, 1984).  Hypophagia was the major cause of adipose  and Ijsan tissue
 loss in male Fischer 344 rats, C57B1/6  mice and albino guinea pigs whbn exposed
 to  a  calculated  LD80 dose of  TCDD.   Body  weight loss followed a similar time-
 course in TCDD-treated and pair-fed control animals of all three speciejs (Kelling
 et  al.,  1985).   Thus, body  weight loss  appears to contribute to lethality in a
 species- and strain-dependent fashion,  but weight loss appears to pla^ a greater
 role in causing death  in Sprague-Dawley rats and guinea pigs than |Lt does in
 Fischer 344  rats and C57B1/6 mice.  Loss of body weight and loss of appetite  are
 alBO prominent signs  of thyroid dysfunction.  However, some  data indicate that
 the effect  of TCDD on thyroid hormones  cannot explain the TCDD-induced decrease
  in body weight gain.
       TCDD-induced wasting is always accompanied by the loss of adipose tissue.
  The rate of fat storage is  determined by LPL, which controls the serum level of
  triglycerides.  Brewster and Matsumura (1984) found in guinea pigs tjiat the LPL
  activity was  decreased to 20% of  the  value of ad libitum  fed controls after
                                       3-14
                                                                        08/11/92

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                         DRAFT—DO NOT QUOTE OR CITE

1 day, and  this  effect persisted throughout the  study (10 days).   Thus,  the
authors suggested  that TCDD irreversibly  reduces adipose LPL  activity,  thus
making the animals less capable to adapt to nutritional changes and needs.
     In a series of studies on Wistar rats, Lakshman et al. (1988, 1989, 1991)
have demonstrated that single intraperitoneal injections of TCDD  (from 1 jjg/kg)
caused a dose dependent inhibition of fatty acid synthesis in the liver and the
adipose tissue.   The adipose tissue  was  found to be  more  sensitive than, the
liver.  Furthermore,  they also found an increased mobilization of depot fat into
the plasma  compartment accompanied by  an increase in plasma  free-fatty acid
concentrations.
     In vitro studies in isolated heart-mitochondria have  indicated that a TCDD
concentration of 1.5 nmol/mg mitochondrial protein affects oxygen activation
associated with  cell  respiration.  Superoxide  radicals and  ^2°2 were indicated
to be involved in the development of  the effects  observed (Nohl et al., 1989).
     Loss of muscle tissue accompanied by  a decreased  glucocorticoid receptor-
binding  capacity  and an  increased  glutamine synthetase activity  have been
observed in male Fisher 344N  rats given a single oral TCDD dose of 100  pg/kg (Max
and Silbergeld 1987).
     Another biochemical effect noted in TCDD-induced  wasting is the  ability of
TCDD to decrease hepatic vitamin A storage in animals (Thunberg et al., 1979;
Hikansson et al., 1989b, 1991).  Vitamin A is  necessary for  growth, and vitamin
A deficiency will result in depressed body weight gain  as well as in reduced food
intake.  However,  in  contrast to  TCDD-treated  animals, the vitamin A deficient
animals continue to  eat and grow, though body weight gain is less than  normal
 (Hayes, 1971).
      That decreased feed intake could be a result  of a direct TCDD effect on the
brain was  initially  indicated by Pohjanvirta et al.  (1989), but this has been
contradicted by  later studies  (Stahl and  Rozman,  1990).   The administration of
TCDD  at  50 pg/kg  intraperitoneally to  male Sprague-Dawley  rats  caused  a
 significant decrease in the serum concentration  of prolactin detectable  after
 4 hours, compared to pair-fed  vehicle controls and noninjected  controls  (Jones
 et al., 1987).   The rapid onset of this effect  suggested that it may be mediated
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                          DRAFT—DO NOT QUOTE  OR CITE
by a  pathway other  than through interaction with  the Ah receptor.   Further
studies have demonstrated that  the  effect  of TCDD was reversed by pimozide, a
doparaine receptor antagonist, and that the rate constant of dopamine depletion
after  a-methyl-p-tyrosine,  as well  as  the turnover  rate,  were significantly
elevated in the median eminence.  This suggested  a hypothalamic site JDf action
of TCDD in their experiments  (Russell et al., 1988).                 j
     Changes in intermediary  metabolism have been demonstrated  in TCD^-treated
expariraental animals.  Conflicting data on effects on serum glucose  and hepatic
glucogen  levels have been  reported  earlier  (WHO/IPCS,  1989).  Several recent
studies have suggested that the ultimate cause of death in some mammalian species
may  be caused by  a progressive hypoglycemia (Ebner  et al.,  1988;  Gorski  and
Rozman,  1987;  Gorski et al.,  1990).   However, in  the guinea pig,  serum glucose
levels were not affected by  treatment of the animals with  TCDD (Gasiewicz  and
Neal,  1979).   Slight reductions  in serum glucose  levels were noted in both Long
Evans and Han/Wistar rats (Pohjanvirta et al., 1989).  Rozman et al.  (1990) have
 suggested that the subchronic and chronic toxicities  of TCDD are related to the
 inhibition of key  enzymes of  gluconeogenesis.    They demonstrated  that  the
 induction of appetite suppression starts is preceded by the  inhibition! of PEPCK,
 which caused a reduction in gluconeogenesis.  This was followed  by a progressive
 increase in plasma  tryptophan levels which was suggested to cause a serotonin-
 mediated reduction of the feed  intake.  In Sprague-Dawley rats,  TCDD in doses of
 25  and  125 pg caused  a rapid  decrease  (50%)  in PEPCK activity 2 days after
 dosing, which was followed by a dose-dependent decrease in glucose-6-phosphatase
 activity 4 or 8 days after exposure.  Both appetite suppression and reduced PEPCK
 activity occurred in the  same  dose  range  (Weber et al.,  1991).   TCpD-induced
 impairments  of carbohydrate synthesis have  also been suggested by ptudies in
 chick embryos (Lentnek et  al.,  1991).
       Numerous studies have measured serum levels of free fatty acids, cholesterol
 and triglycerides in various species after TCDD-treatment (WHO/IPCS,  1989), but
 no pronounced Qualitative differences have been  observed between jspecies or
                                                                     j
  strains of mice.                                                    j
       The wasting syndrome  thus  seems to be a generalized effect, elicited in all
  species and strains, but at various dosages (single or repeated administration).
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                         DRAFT—DO NOT QUOTE OR CITE

Specific studies  have not  been performed  to  elucidate  if  this  syndrome  is
elicited through the interaction of TCDD with the Ah receptor.  However, strong
support for an Ah receptor-mediated mechanism comes from studies with other CDDs
and CDFs.  The binding affinities of various CDDs and CDFs to the Ah receptor as
well as those of related PCBs have been shown to strongly correlate with their
potency of induction of the wasting syndrome in both rats and guinea pigs (Safe,
1990).
3.5.2.   Hepatotoxicity. TCDD induces hyperplasia and hypertrophy of parenchymal
cells  and,  thus,  hepatomegaly in all species  investigated,  even at sublethal
doses.  There is, however,  considerable variation  in the extent and severity of
this  lesion among the species  tested.   Other liver  lesions  are  more species
specific.  Lethality following the administration of TCDD cannot be explained by
these  liver lesions alone, although they may be a  contributing factor,  at least
in the rat and  rabbit.  The morphological changes  in  the liver are accompanied
by  impaired liver  function,  which  is characterized  by liver enzyme  leakage,
increased  microsomal  monooxygenase  activities,   porphyria,   impaired plasma
membrane function, hyperlipidemia and increased regenerative DMA-synthesis  (U.S.
EPA,  1984, 1985; WHO/IPCS,  1989).
      The hepatotoxic reaction in various  strains  of rats given  lethal  doses of
TCDD  is characterized by degenerative and necrotic changes,  with the appearance
of  mononuclear cell infiltration, multinucleated  giant hepatocytes,  increased
numbers of mitotic figures and pleomorphism  of   cord  cells,  increase in the
hepatic smooth  endoplasmatic reticulum  and  parenchymal cell  necrosis.   The
histological findings are accompanied by hyperbilirubinemia,  hypercholesterol-
emia, hyperproteinemia,  increased SCOT and SGPT activities,  further  indicating
damaged liver function  (WHO/IPCS, 1989).  These lesions may be severe enough to
 be a contributing factor in death.   The lesions observed after sublethal  doses
 are qualitatively almost identical to those after lethal doses.
      Earlier studies in mice have found similar effects.  Recently, Shen et al.
 (1991)  reported a  comparative study  on  the hepatotoxicity  of TCDD  in  Ah
 responsive and nonresponsive mice (C57BL/6J and DBA/2J,  respectively).  C57BL/6J
 mice given a single dose of 3 /jg/kg TCDD developed mild to moderate hepatic lipid
 accumulation  but   no  inflammation  or  necrosis.    Severe  fatty  change,  mild
                                      3-17                             08/11/92

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                          DRAFT — DO NOT QUOTE OR CITE
inflammation and necrosis  occurred  at 150
                                                   DBA/2 J mice  given 30
developed hepatocellular necrosis and inflammation but no fatty change.  Lipid
accumulation was only slight after 600 pg/kg.  The authors concluded thjat the Ah
                                                                     i
locus may be involved in determining the steatotic effects of TCDD.  j
     The guinea pig shows less severe morphological alteration in the  l|iver than
in other species.  Likewise, the hamster exhibits little or no liver dajmage even
after a fatal dose, but  liver lesions have been observed after prolonged periods
following the  administration of nonlethal doses.                     j
     Several parameters relating to disturbed hepatic plasma membranae!  function
have been studied (U.S.  EPA, 1984, 1985; WHO/IPCS,  1989).  ATPase activities were
depressed, and protein kinase C activity was increased in rats, but not] in guinea
pigs, treated  with TCDD (Bombick et al.,  1985).  TCDD also induced a dejcrease  in
the binding  of EGF.                                                  j
      The relative doses of TCDD  needed  to suppress EGF binding to 5^% of  the
 control level were 1, 14 and 32 pg/kg for the guinea pig, the Sprague-Dawley rat
 and the Syrian Golden hamster, respectively (Madhukar et al.,  1984). j  A single
 intraperitoneal dose of 115 pg TCDD/kg bw decreased the EGF binding by 93.1, 97.8
 and 46.0% in  C57B1/6, CBA and AKR mice, respectively,  10 days after I treatment
                                                                     I
 (Madhukar et  al., 1984).                                            !
      Further  studies on the interaction  of TCDD with EGF have been performed in
 congenic mice of  the strain  C57BL/6J (Lin et  al.,  1991a,b).  The ED50 for the
 TCDD-induced  decrease in the  maximum binding capacity of the EGF receptor was 10
 times higher in the Ah-nonresponsive mice,  compared to the Ah-responsive animals.
 This  study  supports the hypothesis  that  the  effects of TCDD  on  EGF receptor
 ligand binding  may  be mediated by the Ah  receptor.                  j
       The effects of TCDD on biliary excretion of various compounds have  also been
 studied.  Of special interest are studies on the excretion  of ouabaih, a model
 compound  for neutral nonmetabolized substrates such as estradiol, progesterone
  and cortisol, which was depressed in a dose-related manner by a single j  oral dose
  of TCDD in rats  (Yang et al., 1977, 1983b).  The available data suggest that the
  hepatic membrane  transport of  ouabain  may be selectively  impaired  by TCDD.
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                         DRAFT—DO NOT QUOTE OR CITE

Peterson et al. (1979a,b) have indicated that changes in ATPase activities are
not responsible for the reduced ouabain excretion.
     TCDD administration stimulates  the accumulation of porphyrins in the liver
and  an increase  in urinary  porphyrin  excretion.    Indeed,  during  manifest
porphyria, accumulation of porphyrins occurs not only in the liver but also in
the kidney and spleen of rats (Goldstein et al., 1982).
     Contradictory results on species variations have  been published.  It seems
clear that porphyria can be produced in both mice  and  rats but  the condition is
always the result of subchronic or chronic administration.  Exposure to single
doses has not been demonstrated to produce porphyria.  The mechanism underlying
the induction of porphyria  is not elucidated. Cantoni et al.  (1981) exposed rats
orally  to 0.01,  0.1 and  1 fjg TCDD/kg  bw/week  for  45 weeks  and increased
copropporphyrin levels  were observed at all dose  levels.   A marked porphyric
state appeared only at the highest dose tested, after 8 months of exposure.
     TCDD is a potent inducer of rodent and murine ALA-synthetase, the initial
and  rate-limiting  enzyme involved in heme synthesis.   However,  increased ALA-
activity was not  found  in  mice exposed  to 25 pg TCDD/kg bw/week for 11 weeks,
despite porphyria  being  evident (Jones and Sweeny, 1980).  Thus, the induction
of  ALA-synthetase  does not  seem  to be  a necessary  event  in TCDD-induced
porphyria.   A more likely suggestion is that  decreased hepatic porphyrinogen
decarboxylase is the primary event in porphyria induced by halogenated aromatics
 (Elder et al., 1976, 1978).  TCDD depresses this enzyme activity in  vivo  in the
 liver  of mice  (Cantoni  et al., 1984a,b;  Elder and  Sheppard,  1982? Jones and
 Sweeny,  1980),  but not  in  vitro (Cantoni et al.,  1984b).
     A comparative study  of TCDD-induced  porphyria  has not been conducted  in
 responsive  and nonresponsive mice.   However, in a study on  Ah responsive (Ah")
 and  Ah  nonresponsive   (Ahd) C57BL/6J female mice,  the  urinary excretion  of
 porphyrins was studied after treatment of the animals with hexachlorobenzene for
 <17  weeks  (Hahn  et al.,  1988).   After  15 weeks  of treatment with 200  ppm
 hexachlorobenzene in the diet,  the excretion of porphyrins was 200 times  higher
 in the Ah** mice, compared  to controls.  In contrast, the Ah" mice only showed a
 6-fold increase.   Induction of  P-450c(lAl) was observed only in Ahb mice, while
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                          DRAFT—DO NOT  QUOTE OR CITE
                                                                     i
induction of P-450d(lA2) was observed in both strains, but to a lesser Degree in
the Ahd mice.
3.5.3.   Epidermal Effect*.  Chloracne and associated dermatological changes are
widespread  responses to TCDD  in humans.    However,  this type  of  toaiicity is
expressed only in a limited number of animal species (i.e., rabbits, monkeys and
                                                                     i
hairless mice).
     In the rabbit  ear  bioassay, a total doses of  80  ng  TCDD gave  a chloracne-
genic response, while no response was obtained when the total dose applied to the
ear was 8 ng (Jones and Krizek, 1962; Schwetz et al., 1973).   The application of
TCDD in various vehicles has been demonstrated to markedly decrease this  response
 (Poiger and Schlatter,  1980).  The hairless mouse is a less  sensitivejmodel for
chloracnegenic response than  is the rabbit ear bioassay (Knutson and Poland,
 1982;  Puhvel et al., 1982).  However, following repeated  applications of -0.1 fjg
TCDD  over several weeks, an acnegenic  response  was noted in the hairless mouse
 strains,  SkH;HRl and HRS/J.   An acnegenic response was also caused b|  repeated
 applications of 2 mg 3,4,3',4'-TCB (Puhvel et al.,  1982). Female HRS/J hairless
 mice have  also been used  to test the  dermal  toxicity and skin tumor  promoting
 activity of TCDD,  PeCDF and HxCDF  (Hebert et al., 1990a).  All of  the tested
 compounds  induced  coarse, thickened skin with occasional  desquamation; these
 effects were more  severe  after the application of PeCDF and HxCDF.
      Keratinocytes, the principal cell type in the epidermis, have  been utilized
 as an in vitro model for  studies of TCDD-induced  hyperkeratosis both  in human-
 and  animal-derived cell  cultures.   The  response to TCDD  is  analogous to the
 hyperkeratinization observed  in vivo.
       A TCDD-induced keratinization response  in vitro was first demonjstrated in
 a keratinocyte  cell  line derived from  a  mouse teratoma  (XB  cells).   The
 keratinization was dose-related (Knutson and Poland, 1980b).    Late passage XB
 cells (termed XBF cells)  lost their ability to respond by keratinizjation upon
 TCDD treatment.  Both  XB-cells  (keratinization assay) and XBF-cells  (flat-cell-
  assay)  have proven to  be useful in in vitro bioassays to determine the "dioxin-
  like" activities of both environmental samples and of pure isomers (Qierthy and
  Crane,  1985a,b; Gierthy et al., 1984).                              j
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     Several continuous  lines  of human  keratinocytes,  derived from  neonatal
foreskin or squamous cell carcinomas, have been shown to respond to TCDD in nmol
concentrations with a  variety of signs  indicating alterations in  the normal
differentiation program (WHO/IPCS, 1989).  The responses include decreased DNA
synthesis, decreased number of proliferating basal cells, decreased binding of
EGF and an increase in the state of differentiation (Osborne and Greenlee, 1985;
Hudson et al., 1986).   The responses were also obtained with TCDF but not with
2,4-diCDD  (Osborne and Greenlee,  1985).   TCDD has  also  been shown to inhibit
high-density growth arrest in human  squamous carcinoma cell lines, and, indeed,
the minimum concentration for increases in cell proliferation was 0.1 nM in the
most  sensitive cell line  (SCC-15G).   In studies  on  the  same cell  lines a
modulating  effect  of  the  transforming  growth   factor beta  could  not  be
demonstrated  (Hebert et al., 1990 b,c).
3.5.4.   Enzyme  induction.   TCDD  has repeatedly  been  found to  increase the
activities of various enzymes.  While observations of enzyme inhibition have also
been  made, enzyme  induction has  been  one  of the most  extensively studied
biochemical responses produced by TCDD.  The MFO system  is the most thoroughly
investigated,  and AHH  and  EROD  (as  markers for CYP1A1  induction)  are the most
frequently assayed  enzyme activities.   The induction of MFO activities might
potentiate the  toxicity  of  other  foreign  compounds  requiring  metabolic
transformation by the MFO system before  they can exert  their toxic effect.
Furthermore, increased MFO activities might adversely affect important metabolic
conversions of endogenous  compounds.  TCDD has also been reported to affect  a
variety of other enzymes  (e.g., UDPGT and GST), which are multi-functional enzyme
systems involved in conjugating a wide variety  of structures and play a key role
in biotransformation and detoxification  of endogenous and exogenous compounds.
      Several   investigators  have  studied  the  relative  potency  of   various
halogenated dioxins,   dibensofurans  and biphenyls  to  induce AHH and/or EROD
activities (Safe, 1990).  An apparent structure-activity relationship  was  found
between the location of  the  halogen atoms on the  dibenzo-p-dioxin molecule  and
the ability to  induce AHH activity both in vivo  and in vitro.   Isomers with
halogens  at  the four  lateral  ring  positions produced  a greater biological
response than those with  halogens  at three  lateral ring positions, while  two
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                          DRAFT—DO NOT QUOTE  OR CITE
lateral halogen atoms seemed to be insufficient to produce a biological response.
Numerous studies have indicated that there is very good agreement between the Ah-
binding affinity of various  CDDs, CDFs and related  PCBs and their potency to
induce AHH, both in vivo and in vitro (Safe, 1990).   Structure-activity studies
have  also demonstrated clear  correlation between the  toxicity and induction
potency of a series of CDDs, CDFs and coplanar PCBs (Poland and Glover,  1973;
Safe, 1990).                                                         j
      On a molecular basis, TCDD is the most potent MFO-inducing compound  known,
and MFO induction seems to be  the most sensitive  biochemical response  produced
by it.  The measurement of the  induction of AHH or EROD (mediated through CYP1A1)
are considered to be very  sensitive markers of the TCDD-induced enzyme induction.
According to Kitchin and Woods (1979), induction in the  rat takes place at doses
as low as 0.002 pg TCDD/kg bw.   The  NOEL for  a  single administration to rats
seems to  be 1 ng/kg, while a  single dose of 3 ng/kg causes a detectable induction
of AHH or EROD (Kitchin and Woods, 1979; Abraham et al., 1988).
      Enzyme induction has also been observed in the offspring of variojs species
 after prenatal and postnatal (milk) exposure to TCDD (Lucier  et  al., 1975; Korte
 @t al., 1990; Warn et al., 1991b).                                  j
      The  effect of TCDD on enzyme activities has been most frequently investi-
 gated in the rat (WHO/IPCS,  1989).  In the liver, TCDD has been  shown to increase
 both the contents of cytochrome P-4501A1 and  cytochrome P-4501A2, as well as
 other raicrosomal enzyme activities involved in the oxidative transformation and
 conjugation of xenobiotics (e.g., aniline hydroxylase, AHH, biphenyl hydroxylase,
 ECOD, EROD and UDPGT)  (U.S. EPA 1984,  1985; WHO/IPCS 1989).
      TCDD also affects some other hepatic enzymes not related to the MFO  system,
 including aldehyde dehydrogenase B-aminolevulinic acid synthetase, DT-diaphorase,
 transglutaminase,  ornithine decarboxylase, transaminases (ALT  and AST),  plasma
 membrane ATPases,  porphyrinogen carboxylase,  prostaglandin  synthetasje,  enzymes
  involved in testosterone metabolism and  RNA polymerase (U.S.  EPA,  Ij984,  1985;
  WHO/IPCS 1989).
       Studies in different  species have  revealed  that  enzyme  induction,  due  to
  TCDD exposure is also both a species- and strain-specific  phenomenon. Pdrjawirta
  et al.  (1988)  studied enzyme  induction in the Long-Evans and Han/Wistar (Kuopio)
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                         DRAFT—DO NOT QUOTE OR CITE

rat  strains  (LD50,  -10 and  >3000  /jg,  respectively).    Differences in  the
inducibility of EROD, ECOD or ethylmorphine N-demethylase  were not found,  nor
were there any differences as regards the amount of available Ah receptor or the
amount of  cytochromes  P-450  in the hepatic microsomal  fractions.   Similarly,
differences regarding possible  induction of UDPGT were absent (Pohjanvirta et
al., 1990).
     Enzyme induction studies on  mice have been performed mainly with strains
which are genetically different at the Ah locus, thus making them responsive or
nonresponsive  to  the induction of hepatic cytochrome  P-4501A1 related enzyme
activities.  Qualitatively and in  general, the same responses can be obtained in
both strains,  but there may  be more than  one  order of magnitude difference as
regards  the doses required to  elicit a  response.  TCDD  is thus 10-fold more
potent in  inducing hepatic cytochrome P-4501A1 and the related AHH activity in
C57BL/6J mice  (Ah-responsive) than in DBA/2 mice (Ah-nonresponsive)  (Poland and
Knutson, 1982; Nebert,  1989).
     The guinea  pig, although  it is the species most  sensitive  to the toxic
effects  of TCDD,  does  not respond  to the administration  of  TCDD with liver
toxicity nor with extensive enzyme induction.  Indeed, even at lethal doses, the
induction  of  MFO  is  only very  slight (Beatty and  Neal, 1977; Hikansson et al.,
1992).
     The data on enzyme induction  in rabbits are rather limited and also somewhat
conflicting as regards  increases  in cytochromes P-450  (Hook et al.,  1975; Liem
et al.,  1980).
     Similarly,  hepatic enzyme induction  has only been  partially  studied in
Syrian Golden hamsters.  When  hamsters  were given  a  lethal  dose of TCDD,
increased hepatic GST and glutathione reductase activities were found.  The £050
values for the induction of hepatic ECOD and reduced NADP:  menadione oxidoreduc-
tase activities and  cytochrome P-450 content in male Syrian Golden hamsters were
 1.0, 2.0 and 0.5 pg TCDD/kg bw, respectively (i.e., extremely low doses, compared
to doses that  produce tissue damage and lethality  in this species) (Gasiewicz et
 al.,  1986).
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                          DRAFT—DO NOT QUOTE OR CITE                  I

     In a comparative study on EROD induction in guinea pigs, rats, C57BL/6 and
DBA/2 mice,  as  well as Syrian Golden hamsters, the animals were given single
dose» that  were intended to  be equitoxic (i.e.,  1,  40,  100, 400  and 400 pg
TCDD/kg,  respectively)  compared  with  the acute  toxicity  for  the respective
species  and strain.  EROD  induction was noted in all species  exceptj for the
hamster.  During the observation  period  (112 days), the-EROD induction dropped
to more or  less normal values in all  rats and mice, while  the inductiop  (albeit
low  compared to the other  species) was  sustained for the whole peripd in the
                                                                      I
guinea pig  (Hakansson  et  al., 1992).                                  j
     The N-demethylation of caffeine has been applied as & noninvasive method for
studying enzyme induction in  vivo.  Studies on the marmoset monkey (Callithrix
jacchus)  utilizing  14C-labeled  caffeine and  measuring  14CO2  exhalation by  a
breath test has indicated a NOEL of 1 ng/kg and a LOEL  of 3 ng/kg  (Kruger et al.,
 1990).  Although the authors stated that the N-demethylation  of caffeine probably
was P-4501A1  dependent,  studies by Butler  et al.  (1989)  indicate  fhat  this
                                                                      j
 reaction is dependent on cytochrome P-4501A2.                         j
      in the chick  embryo,  both AHH and  6-aminolevulinic  acid synthetase  have
 been reported  to  be extremely  sensitive to the  inductive  effects of TCDD and
 related  compounds (Poland and  Glover,  1973; BrunstrSm  and Andersson,  1988;
 BrunstrSra,  1990).                                                    \
      Although TCDD  is relatively nontoxic in cell cultures, it  is a very potent
 inducer of AHH or EROD activities in systems,  including lymphocytes and primary
 hepatocytes,  as well  as  established and transformed  cell lines.      !
      The   ED50  values for AHH-induction  by TCDD   have been  studied  in   11
 established cell lines and in fetal primary cultures from  five animal species and
 cultured human lymphocytes and ranged from 0.04  ng/mL medium in  C57B1/6 mouse
 fetal cultures and 0.08 ng/mL in  the rat hepatoma H-4-II-E cell line to >66 ng/mL
 in the  HTC rat hepatoma cell line  (Niwa et al.,  1975).   Several cultured human
 cells or  cell lines  have  been shown  to be inducible for  AHH activity by TCDD
  [e.g.,  lymphocytes (Atlas et al.,  1976),  squamous cell carcinoma lines (Hudson
  et al.,  1983), breast carcinoma cell lines (Jaiswal et al.,  1985) and ijymphoblas-
  toid cells (Nagayama et al.  1985)].                                  j
                                       3-24
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                         DRAFT—DO NOT QUOTE OR CITE

     TCDD was demonstrated to be the most potent AHH inducer of 24 chlorinated
dibenzo-p-dioxin analogues (Bradlaw et al., 1980) in a rat hepatoma cell culture
(H-4-II-E), which is extremely sensitive to AHH induction.   The EC50 values for
AHH- and  EROD-induction in the same cell system varied over  seven  orders of
magnitude for 14 different CDDs, the most potent being TCDD  and the least potent
being 2,3,6-triCDD  (Mason et al., 1986).
     The  feasibility of using in vitro EROD induction to determine dioxin-like
activities of  environmental samples has  been  demonstrated by  several studies
(Zacharewski et  al.,  1989; Hanberg et al., 1991).   However, in environmental
samples there exists a variety of compounds which bind to the Ah receptor.  Some
of them might act as antagonists to the binding of CDDs and  CDFs and,  thus, give
an erroneous result.  The  synthetic compound,  6-methyl-l,3,8-trichlorodibenzo-
furan, has been  shown to inhibit the binding of TCDD to the Ah receptor and to
antagonize the induction  of both P-4501A1 and P-4501A2 in the rat (Astroff et
al., 1988).
     3.5.5.1.    Appraisal.   Based on the data from Kitchin and Woods (1979),
Abraham  et  al. (1988)  and Kruger et al.  (1990), Neubert (1991) has  calculated
NOEL values  for  enzyme  induction  in both rats  and marmoset monkeys to a single
dose of  1 ng/kg bw.  At this dose, the tissue concentrations for both species
were  found to be  4 ppt for  adipose  tissue and 3  ppt for the  liver.   It is
interesting  to  note  that the wide  range of  sensitivities towards  the acute
toxicity of  TCDD is also  reflected  in  a wide  range  of  sensitivities  for enzyme
induction both in vivo and in vitro.  However,  it is evident that the  guinea pig
is fairly insensitive to enzyme induction, while the hamster is highly sensitive
in this  respect.
     Finally,  it is evident that the  structure-activity relationships revealed
from in  vitro  testing correlate fairly well with in vivo studies within a given
species  or strain.
 3.5.6.    Endocrine Effects.   Alterations  to endocrine regulation  have  been
 suggested from human exposure to TCDD that resulted in hirsutism and  chloracne.
 Chronic  exposure to TCDD  causes impaired reproduction  in  experimental  animals
 possibly by interfering with the estrus  cycle  in combination with some steroid-
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                          DRAFT—DO NOT QUOTE OR CITE
                                                                      i
like actions of TCDD.  This has prompted studies on the interaction of TCDD with
steroid hormones and their receptors.                                 |
     Increased systemic levels of glucocorticoids may mimic some of the j symptoms
of TCDD-toxicity (e.g., involution of lymphoid tissues,  edema and mobilization
of fatty acids from adipose tissues).  Thus, TCDD has been  suggested to increase
glucocorticoid  activity through  indirect  effects on glucocorticoid receptors.
Poland et al.  (1976) have demonstrated that cortisol and synthetic gltjicocorti-
coids did not bind to the TCDD receptor.                              j
     Conflicting data have been reported on TCDD-induced levels of glxicocorti-
coids.   However,  significant changes  to  the  liver cytosolic  glucocorticoid
receptor were induced by TCDD at doses 10,000 lower in adrenal ectomizedl Sprague-
Dawley  rats,  compared  to control  rats  (Sunahara  et al.,  1989).    The data
furthermore indicate that it is the binding properties of  the receptor, that are
affected rather than the amount of receptor protein.   Studies in congenljc strains
of  Ah  responsive and Ah nonresponsive C57BL/6J female mice  (Goldsteih et al.,
1990; Lin et al., 1991a,b) have also demonstrated that TCDD decreased trie maximum
binding capacity of the hepatic glucocorticoid receptor in both  strains of mice
by -30%.  Differences in dose-response curves between the different strains could
not be observed.   These  data suggests that this effect  may be mediated by  a
pathway different from that  mediated by the Ah receptor.              |
      Steroids are endogenous substrates for the hepatic MFO system.  TGDD, which
 influences the activity of this enzyme system,  may thus alter steroid metabolism
 in  vivo and, consequently,  also the magnitude of steroid  mediated functions.
      Early studies also reported contradictory data on changes in steroid levels.
 However, Umbreit and Gallo (1988) suggested that estrogen receptor modulation and
 the animal's physiological response to this modulation can explain some of the
 toxicity observed in  TCDD-treated  animals.   The  susceptibility  of jdifferent
 species to TCDD correlates,  to some extent, with their steroid glucuronidation
 capacity.  Thus, hamsters have low steroid UDPGT activity  while guinea! pigs have
 a  corresponding high  activity.   Another example   is  given by  comparing  the
 Sprague-Dawley (S-D) and Gunn rat,  the latter being defective in producing some
 UDPGTs.  The homozygous Gunn rat is  3-10 times more  resistant to effects  of TCDD
 than is the S-D rat (Thunberg, 1984;  Thunberg  and Hakansson,-1983). However, the
                                                                      i
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                         DRAFT—DO NOT QUOTE OR CITE

results of TCDD exposure in various species and strains are complex.   In order
to counteract the TCDD-induced modulation of the estrogen receptor, the effects
observed will  be dependent on the ability of  the organism to  synthesize and
excrete estrogens. Interactions of TCDD and related compounds with estrogen have
recently been reviewed by Safe et al. (1991).
     The importance of estrogens as modulators of TCDD-induced toxicity has also
been demonstrated by  Lucier  et al.  (1991), who found that the tumor-promoting
effects of  TCDD could be  effectively prevented by removing the  ovaries from
female rats before exposure to TCDD.   This  finding agrees well with the results
obtained  from the long-term bioassays that demonstrated  liver  tumors only in
female rats  (Kociba et al.,  1978; NTP, 1982).
     In  studies  on  coiigenic  strains of  Ah-responsive  and  Ah-nonresponsive
C57BL/6J female mice, a statistically significant  difference in  the responsive-
ness of the hepatic  estrogen receptor was found,  thus indicating that the Ah
receptor regulates the effects of TCDD on the binding of estrogen to the hepatic
estrogen  receptor (Goldstein et  al.,  1990; Lin et al.,  1991a,b).
     TCDD-induced changes  in levels or  activities  of  testosterone  or  its
metabolites have been reported from several studies (Keys et al.,  1985; Mittler
et al., 1984; Moore and Peterson,  1985).  The data  do not, however, allow for any
conclusions with regard  to the  possible relationship  to receptor-mediated
toxicity.  TCDD induces several enzymes related to testosterone metabolism, which
has suggested that the  changes  observed may be secondary to the induction of
various  enzymes.  Serum testosterone and  dihydrotestosterone were found to be
dose-dependently depressed by TCDD treatment in male Sprague-Dawley  rats, when
 compared  to pair-fed and ad libitum fed controls. The ED50 for  this  effect was
 -15 /i/g/kg  (Moore et al.,  1985).   It  was further  shown  that   testosterone
 synthesis was decreased in the animals due to depressed production of pregneno-
 lone by the testis  (Kleeman  et al., 1990).   In the same strain of rats, a single
 oral dose of TCDD of 100 pg/kg was found to cause a 55% decrease in testicular
 cytochrome P-ASO^ activity but  also to cause the  inhibition of the mobilization
 of cholesterol  to  cytochrome P-450^.   The authors  concluded  that  the latter
 effect probably was responsible for the inhibition of testicular steroidogenesis
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DRAFT—DO NOT QUOTE OR CITE
                                           T3 and TSH
(Moore et al.,  1991).   Despite this, the effects noted occur after  exposure to
largo amounts of TCDD.  In contrast, maternal exposure to TCDD has been shown to
affact the male  reproductive  system at much lower doses (i.e.  the lowest dose
tested was 64 ng/kg) (Mably et al., 1991, 1992a,b,c) (see Chapter 5)|.
     In-ovo  exposure of  white Leghorn chickens to TCDD in the dose range of
1-10,000 pmol/egg increased the cardiac release of prostaglandins (Quilley and
Rifkind, 1986).  Studies on chick embryos have indicated that the TCDD-induced
induction of cytochromes P-450 species results in a major increase  in  the NADPH-
dependent metabolism of arachidonic acid (Rifkind  et al.,  1990).  These effects
are thus clearly related to the receptor mediated  enzyme  induction.
     Rather  conflicting data have been published regarding TCDD-induced effects
on thyroid hormones (WHO/IPCS, 1989).  The available data on serum T4,
levels  are  not sufficient  to  state  whether  or  not  TCDD-treated;  rats are
functionally hypothyroidic, euthyroidic or  hyperthyroidic.          !
     However,  Brouwer  (1987)  has demonstrated that a "dioxin-like" |PCB  (i.e.,
3,4,3',4'-TCB,  through a rapidly produced metabolite,  5-OH-TCB) birds to TTR.
This  binding causes interactions with the  physiological functions of TTR and
                                                                    i
thyroid hormone transport is  severely  affected.   This finding  may explain some
of  the characteristic  toxicological  lesions found after PCB  exposure.
                                                                    I
3.5.7.    Vitamin A  Storage.    Decreased hepatic  vitamin A  storages has  been
reported in animals exposed to various chlorinated aromatic compounds.  TCDD is
unique in  its  ability  to reduce the  vitamin A content of  the liver,  both
regarding the minute quantities needed to produce this effect and the persistence
of the effect.  A single oral dose of 10 fig TCDD/kg bw decreased bot^i the total
 amount and  the  concentration of vitamin A  in the liver of  adult  male Sprague-
 Dawley rats (Thunberg et al., 1979).   The decrease was evident  4
 dosing and progressed  with time.  After 8 weeks, the treated animals
 liver vitamin  A content corresponding to 33% of  that  of controls..  Decreased
 dietary intake of vitamin A could not account for this difference.  A significant
 increase in the UDPGT activity was observed, suggestive of an increased excretion
 of glucuronide conjugated vitamin A.  However, no correlation between the UDPGT-
                                           days  after
                                           had a total
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                         DRAFT—DO NOT QUOTE OR CITE

activity and the hepatic vitamin A reduction was seen when homozygous Gunn rats
lacking inducible UDPGT  (Aitio  et al.,  1979) and  heterozygous Gunn rats, with
inducible UDPGT,  were treated  with  a single,  oral dose  of 10  /^g TCDD/kg bw
(Thunberg and Hakanseon, 1983).
     In a study combining pair-feed restriction and a single TCDD treatment, it
was found that the decreases in liver reserves  of  vitamin A  were  not related to
a decreased intake of vitamin A via the diet (Hakansson et  al.,  1989a).
     Puhvel et al. (1991) reported a comparative study  in which congenic  haired
(+/+) and hairless (hr/hr) HRS/J  mice were fed  a vitamin A-deficient  diet and
treated topically with TCDD.  The sensitivity to TCDD-induced  cutaneous changes
was essentially  100 times higher  in hairless mice  than  in  haired  mice  (0.01 and
1.0 pg 3 times/week for 3 and 2 weeks, respectively).   In  the  haired phenotype,
effects of vitamin A  depletion  by itself  were  not seen by cutaneous histology,
nor were any changes in cutaneous morphology attributable to TCDD observed.   In
the hairless mice, however, vitamin A deficiency increased the keratinization of
dermal  epithelial cysts and increased the sensitivity of these  cysts  to TCDD-
 induced keratinization.  Analysis of vitamin A demonstrated that TCDD-exposure
 did not affect cutaneous levels of the vitamin  but did significantly lower liver
 levels  of vitamin A.   TCDD-induced body  weight loss and  atrophy of the  thymus
 glands  was not affected by the vitamin A status  in either strain.
      In a study on tumor promotion by  TCDD, utilizing the  induction  of  enzyme
 altered hepatic foci  in the liver and performed on female S-D rats, Flodstrom et
 al.  (1991)  found that vitamin A deficiency by  itself enhanced foci development.
 The effect of TCDD treatment was also markedly  enhanced,  as  were other TCDD-
 induced toxicities including thymus  atrophy.
      Several studies  have  been performed to elucidate the mechanism of TCDD-
 vitamin A interaction. Hakansson et al. (1989c) and Hakansson and Hanberg (1989)
 have demonstrated that TCDD  specifically inhibits the storage of vitamin A in
 liver stellate cells.  Brouwer et al. (1989) demonstrated that a single  dose of
 TCDD (10 pg/kg) to female S-D rats reduced vitamin A in the  liver,  the  lung, the
 intestines  and the adrenal  glands  while increasing  its concentration  in the
 serum, the kidneys and the urine.  They  also  found a  150%  increase in the free
 fraction of serum retinol binding protein.  Taken together,  all of these  data in
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                          DRAFT—DO NOT QUOTE OR CITE

the rat indicate that TCDD induces an increased mobilization of vitamin A from
hepatic and extrahepatic storage sites into the serum which is accompanied by an
enhanced elimination of the vitamin via the kidney into the urine.
     In a comparative study of TCDD toxicity in male S-D rats and Hartley guinea
pigs (Hakansson et  al.  (1989b), the  animals were given single intraperitoneal
dose* of 40 and 0.5 /^g/kg bw, respectively (i.e., comparable fractions of their
respective  LD50).   In these  species there were  similar reductions in hepatic
vitamin A, while serum  and renal vitamin A concentration were increased in the
rat, but  unaffected  in the  guinea pig.   Hepatic EROD  activity  wals markedly
increased in the rat but unchanged in the guinea pig.  Furthermore,  although rats
seemed to  recover  from the wasting,  thymic atrophy and liver enlargement, and
resumed  their ability  to store  vitamin  A  in the liver at 4-8  weeks after
exposure,  no such trends  for wasting  and vitamin A  storage  were observed in
guinea pigs, even 16 weeks after exposure.  A complementary study  also included
alao C57BL/6 mice, DBA/2  mice  and Syrian Golden  hamsters (Hakanss|on et al.,
                                                                    i
1991).  The effects on TCDD-induced  decrease of vitamin A in the  liver  and the
lung  correlated reasonably  well with  other  toxic  symptoms observed  in the
animals.   On the  other hand,  studies on two  strains of rats, Long-Evans and
Han/Wistar (the Han/Wistar being >300 times  more resistant to TCDD toxicity)
could  not demonstrate  significant differences in the TCDD-induced changes in
vitamin A  in the liver, the kidney, the testicles or the serum after a sublethal
dose  (4 pg/kg)  (Pohjanvirta et  al.,  1990).   These findings show  that the
correlations between TCDD-induced lethality and changes in vitamin A status found
                                                                    j
among  other species apply to these strains of rats.                 I
     The interaction of 3,4,3•,4'-TCB with vitamin A has been studied by Brouwer
and Van der Berg (1983, 1984, 1986), Brouwer et al. (1985, 1986a,b) and Brouwer
 (1987).  The effects of TCB on vitamin A differs in many respects from those of
TCDD.   TCB is rapidly  converted in  vivo  into  a  polar 5-OH-TCB metabolite,  and
                                                                    consequence
                                                                    and thyroid
                                                                      The model
this metabolite binds with a relatively high affinity to TTR.  As a
of this interaction, the physiological functions of TTR in retinoid
hormone transport  are severely  affected in TCB  exposed  animals.
proposed by Brouwer (1985) may explain some  of the characteristic tpxicological

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                         DRAFT—DO NOT QUOTE OR CITE

lesions related to PCB exposure.  This mechanism of action seems to be clearly
separated from the Ah receptor mediated toxicity of CDDs and CDFs.  Hydroxylated
metabolites of TCDD have also been demonstrated to bind in a similar manner to
TTR (Lans et al., 1992).  However, due to the very slow metabolism of TCDD (or
other 2,3,7,8-substituted CDDs/CDFs), this mechanism of toxicity probably plays
a very minor role in the toxicity.
     Taken together, these data indicate that TCDD interferes with the storage
mechanism for  vitamin A.   As supplementation  of dietary vitamin A seems to be
unable to counteract all of the observed toxic effects, this would imply either
that the effect on vitamin A storage is  secondary to TCDD-toxicity or that the
cellular utilization  of vitamin A is affected by  TCDD.   On the other hand, a
dioxin-like  PCB such as  3,4,3' ,4'-TCB  seems  to  deviate with  regard to this
mechanism of action.
3.5.8.   Lipid Poroxidation.  Lipid peroxidation and oxidative stress have been
indicated as a factor that  affects the acute  toxicity  of  TCDD  (WHO/IPCS, 1989;
Wahba et al.,  1989a,b, 1990a,b; Pohjnavirta et al., 1989; Alsharif et al., 1990;
Stohs et al.,  1990).  Among the effects noted have been membrane lipid peroxida-
tion, decreased membrane fluidity and increased incidence of single strand breaks
in DNA.   Studies relating these observations to the Ah receptor have not been
performed.   However,  when  considering  the available  data on TCDD  and lipid
peroxidation,  it is not possible to attempt  to define a relationship  between
 lipid peroxidation and TCDD-induced  lethality.
 3.6.    MECHANISMS OF TOXICITY
      Despite extensive research to elucidate the ultimate event(s) underlying the
 toxic action of TCDD, definite information is not yet available.   The toxicity
 of TCDD apparently depends  on the fact  that  the  four  lateral positions of  the
 molecule are occupied by chlorine.   Toxicity decreases with decreasing  lateral
 substitution and increasing total chlorine substitution.  TCDD toxicity involves
 many different types of symptoms; these symptoms vary from species to  species and
 from tissue to tissue,  both quantitatively and qualitatively.  Furthermore,  age
 and sex related differences in sensitivity have been reported.  A characteristic
 of TCDD toxicity is also the delay  required to manifest toxicity (from 2 weeks
 to 2 months)  which is seen  in all species.
                                      3-31                             08/11/92

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                          DRAFT—DO NOT QUOTE OR CITE
     Polymorphism in the Ah locus, which has been suggested to be the [structural
gene  for  the  cytosolic  receptor,  seems  to  determine the  sensitivity  of
genetically different  strains of mice to TCDD and congeners.   Ah-fresponsive
strains of mice (e.g.,  C57B1/6) are characterized by high hepatic levels of the
TCDD-receptor protein,  highly elevated levels of hepatic cytochrome P^SOlAl and
associated enzyme activities,  in response to treatment with 3-MC, and sensitivity
to the  ulcerative action  of  DMBA  on the skin.  Ah-nonresponsive  mice (e.g.,
DBA/2)  lack these characteristics.  Based on  these  findings,  several genetic
studies  have  been performed  to elucidate the  role  of  the receptor in TCDD-
toxicity.   In contrast  to 3-MC,  TCDD induces AHH activity  and several toxic
effects both in Ah-responsive and Ah-nonresponsive strains of mice. However, the
dose  required to produce the effect in an Ah-nonresponsive strain :LS approxi-
mately  10-fold greater than that needed in a responsive strain.  Thijs indicates
that  the  Ah-nonresponsive strain  also   contains  the  TCDD-recepto:: but this
receptor is defective  (Okey and Vella, 1982).   Data from studies of  DBA/2 mice
                                                                    I
given either  single or multiple doses of  TCDD  (Jones and Sweeney, 1980;  Smith et
al.,  1981) suggest  that the  LD50 in this  strain  of  mice  is  at least  5-fold
greater than  the values recorded for the  C57B1/6 and C57B1/10 strains (Jones  and
Greig,  1975;   Smith  et  al.,  1981; Vos  et  al., 1974).   TCDD-induced  hepatic
porphyria has also been shown to segregate with the Ah locus in mice (Jones  and
                                                                    I
Sweeney, 1980).   The  correlative  differences between  the  C57B1/6 and  DBA/2
strains of mice,  in terms  of altered specific binding  of TCDD and sensitivity to
this compound,  may be unique  and may not  be applicable to other  species
 (Ganiewicz and Rucci, 1984).  In a genetic crossing experiment between Long-Evans
 and  Han/Wistar rats  (Pohjanvirta,  1990),  it  was   demonstrated  that the  Fl
 offspring were  as resistant  to  TCDD toxicity  as the  Han/Wistar  jrats  (LD50,
                                                                    I
 >3000 /jg/kg).    Further  studies  on  the  F2  generation indicated that  the
 distribution  of  resistant and  susceptible phenotypes  were  consistent  with
 inheritance regulated by two (possibly three) autosomal genes displaying complete
 dominance, independent segregation and an additive co-effect.  Thus,  in contrast
 to the findings in mice, TCDD  resistance seems to be a dominant trait in the rat.
 Less convincing  evidence  for  the model  of a receptor-mediated toxicity of TCDD
                                      3-32
08/11/92

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                         DRAFT—DO NOT QUOTE OR CITE

arise from studies of the toxicity,  receptor levels and/or enzyme-induction of
TCDD in various species, tissues and cell cultures.  Despite enormous variability
in the recorded LD50 values for  guinea pig, rat, mouse, rabbit and hamster, the
amounts  of  and physical  properties  of  the hepatic  as well  as extrahepatic
receptors are comparable in these species (Gasiewicz and Rucci,  1984;  Poland and
Knutson, 1982).   Furthermore,  although the recorded LD50 values for TCDD vary
>100 times between the chick embryo,  the C3H/HeN mice and the Sprague-Dawley rat,
the ED50 doses  for AHH induction in  these  species are comparable (Poland and
Glover,  1974).  Even in strains of rats with a  difference of >300 times in LD50,
no  differences  in enzyme induction could be demonstrated (Pohjanvirta et al.,
1988).   In  the guinea pig,  the  most TCDD-susceptible  species, AHH  induction  is
not a prominent symptom, even at lethal doses of TCDD.  A number of cell  types,
including  primary  cultures and established  and  transformed  cell  lines from
several  species  and  tissues,  are inducible for  AHH activity,  indicating the
presence of the receptor, yet toxicity is not expressed in these systems (Knutson
and Poland, 1980a).  The available data thus suggest that the receptor for TCDD
may be  a prerequisite  but  is  not  sufficient in  itself  for the mediation  of
toxicity.
      TCDD toxicity mimics in many respects endocrine imbalance, although evidence
 indicating a direct involvement of hormones in the toxic action  of TCDD does not
 exist.   However,  the  studies  by Lucier  et  al.  (1991)  clearly  indicate  the
 importance of interactions with estrogen regulation.
      The most  reliable  and consistent  symptom  of  TCDD  toxicity among  all
 experimental animals is that of weight loss.   The  cause of the body weight loss
 seems to be reduced food intake apparently occurring secondarily to a physiolog-
 ical adjustment which reduces the body weight  to a maintenance  level lower than
 normal.  The physiological trigger for this  body weight  set  point  might be a
 target  for TCDD.
      The ability of TCDD to impair vitamin A storage may be responsible for some
 of the  toxic effects produced  by TCDD.
                                       3-33
                                                                        08/11/92

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                         DRAFT—DO NOT QUOTE OR CITE
3.7.   CONCLUSIONS

     From the complex picture that evolves from the above outlined cata,  it is

amply evident that TCDD elicits a plethora of toxic responses, both after short
                                                                   I
term and long-term exposure.   The lowest doses  (single or repeated)  that have

been demonstrated to  elicit various biological responses in certain animals have

been compiled in Table 3-4.  The analysis of the  various signs and symptoms that

occur in various species and strains may lead to the following conclusions:
        When comparing  species  and  strains  it is amply evident that sometimes
        there  are enormous differences  in  the sensitivity to specific TCDD-
        induced  toxicities.   This  conclusion is  valid for  almost  all  the
        responses studied.  However,  qualitatively there seems to be  fairly good
        agreement between the type  of  responses that can  be recorded (i.e.,
        almost all responses can be produced in every species  and strain if the
        right dose  is  chosen).   In highly sensitive species (e.g.,  the guinea
        pig), lethality may prevent  a response occurring.           \

        Our present knowledge, however,  rules out enzyme  induction,  as  such, as
        being the cause of  toxicity  and  death.  Although the toxicokinetics of
        TCDD  vary between  species,  these  differences are not  sufficient to
        explain  the  variabilities  in   sensitivity   to  TCDD   toxicity   (see
        Chapter  1).   The  available data indicate  an involvement  pf  TCDD in
        processes regulating cellular differentiation and/or division as well as
        those  controlling estrogen  homeostasis.  Alterations  in  the regulation
        of such  processes,  which are not equally active in all cells throughout
        the  organism,  would be expected to result  in effects that vary among
        tissues  as  well as  among species.                           I

        The overwhelming number of  toxic  responses to TCDD (including lethality)
        typically show a  delay  in  their  appearance,  which supports  the assump-
        tion that these responses are not the result of a direct insult from the
        compound.                                                   j

        The  induction  of  hepatic  cytochrome P-450  dependent  monboxygenases
         (mainly  CYP1A1) is  one  of  the hallmarks  of  TCDD  exposure.   This effect
        has  been demonstrated  to  be mediated through the  interaction with  a
        specific protein  called the Ah receptor.  This  process covers binding of
        TCDD to  the receptor followed by binding of the receptor-ligand complex
        to DNA  recognition sites  leading to expression of specific genes and
        translation  of  their  protein  products,  which  then  mediate their
        biological  effects.                                        !

         Studies  in congenic mice  which  are Ah responsive or  Ah nonresponsive
         have demonstrated  that the majority of TCDD-induced toxic  responses
         segregate quantitatively with the Ah locus.   However,  the amount of Ah
         receptor expressed in  most laboratory  species  and strains is rather
         comparable.  The  Ah receptor is thus unlikely to be the only determinant
         of TCDD-induced toxicity.  Rather, it has to be assumed that the species
         and strain  differences  are confined to the latter parts of the receptor-
         mediated chain of events,  (i.e., binding of the receptor-ligand complex
         to  DNA  and the  subsequent expression  of  specific  genes).    Another
         explanation may  be that the binding affinity  of  the  Ah  receptor  is
         different  or  defective.    In addition,  some  of  the responses may  be
         secondary in the sense that they are caused by  altered homeostasis  of
         endogenous compounds caused by the  TCDD-induced increased activities of
         various enzymes.                                           !
                                      3-34
OB/11/92

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             3-35
08/06/92

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                         DRAFT—DO NOT QUOTE OR CITE               |
                                                                   I

        It has repeatedly been  reported  that the current opinion  is  that all
        known effects of TCDD are probably Ah receptor mediated (e.g|.,  Roberts,
        1991).   Except for the chain of events  leading to the induction of
        certain enzymes, clear evidence for such a conclusion is still lacking.
        However, the studies  in congenic mice  in  combination with  jthe usually
        rather strong  correlation  between  enzyme induction  and  various other
        TCDD-induced  toxic  responses makes   the  assumption  rather  likely.
        Further support  for the probability of a  receptor-mediated! process is
        provided by the  very  strong  structure-activity relationship which has
        been  demonstrated  between various  CDDs/CDFs and  a variety  of toxic
        responses.
                                                                   I
3.8.   REFERENCES

Abraham ot al.  1988.  Pharmacokinetics and biological activity of 2,3,7,8-tetra-

chlorodibenzo-p-dioxin.  1. Dose-dependent tissue distribution and induction of
                                                                   I
hepatic ethoxyresorufin O-deethylase in rats following a single injection.  Arch.

Toxicol. 62: 359-368.
Ahlborg, U.G., H. Hakansson, G. Lindstrom and C. Rappe.  1990.  Studies on the

retention of  individual polychlorinated dibenzofurans (PCDFs) in the liver of
                                                                   i
different species.  Chemosphere.  20: 1235-1240.                   |
Aitio, A.,  M.G.  Parkki and J. Marniemi.   1979.   Different effect |of 2,3,7,8-

tetrachlorodibenzo-p-dioxin  on glucuronide  conjugation  of various  aglycones.

Studies  in  Wistar  and Gunn rats.   Toxicol. Appl.  Pharmacol.   47:  55-60.
                                                                   i

                                                                   i
Allen, J.R. and  J.J.  Lalich.   1962.   Response  of  chickens  to  prolonged  feeding

of  crude "toxic  fat."  Proc.  Soc.  Exp.  Biol. Med.  109:  48-51.     j

                                                                   I

Allen, J.R.,  D.A.  Barsotti, and J.P. Van Miller, L. Abrahamson and J.J.  Lalich.

1977.  Morphological changes in monkeys consuming a diet containing low levels
                                                                   i
of  2,3,7,8-tetrachlorodibenzo-p-dioxin.  Food Cosmet. Toxicol.  15(|5):  401-410.


                                                                   i
Alsharif,  N.Z.,  C.J.  Grandjean  and  W.J. Murray.    1990.   2,3,7,8-jTetrachloro-

dibenzo-p-dioxin (TCDD)-induced decrease in the fluidity  of rat livejr membranes.

Xenobiotica.  20(9): 979-988.                                     |
                                      3-36
08/11/92

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                          DRAFT—DO NOT QUOTE OR CITE

Astroff, B., T. Zacharewski,  S.  Safe et al.  1988.  6-Methy1-1,3,8-trichloro-
dibenzofuran as a 2,3,7,8-tetrachlorodibenzo-p-dioxin antagonist:  Inhibition of
the  induction  of  rat  cytochrome P450  isozymes  and  related  monooxygenase
activities.  Mol. Pharmacol.   33:  231-236.

Atlas, S.A., E.S.  Vesell and D.W. Nebert.  1976.  Genetic control of interindivi-
dual variations in the inducibility of aryl hydrocarbon hydroxylase  in cultured
human lymphocytes.  Cancer Res.   36s  46190-4630.

Barsotti,  D.A.,  L.J.  Abrahamson,  J.R.  Allen.   1979.  Hormonal alterations  in
female rhesus monkeys fed  a diet containing 2,3,7,8-tetrachlorodibenzo-p-dioxin.
Bull. Environ.  Contain.  Toxicol.   21s  463-469.

Beatty,  P.  and  R.A.  Neal.   1977.   Factors affecting  the  induction of  D-5-
diaphorase by 2,3,7,8-tetrachlorodibenzo-p-dioxin. Biochem. Pharmacol. 27: 505.

Beatty,  P.W.,  K.J. Lembach,  M.A.  Holscher,  and R.A. Neal.   1975.   Effects  of
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on mammalian cells in tissue cultures.
Toxicol. Appl.  Pharmacol.  31: 309-312.

Beatty,  P.W.,  W.K. Vaughn, and  R.A.  Neal.   1978.   Effect of alteration of rat
 hepatic mixed-function oxidase (MFO)  activity on the toxicity of 2,3,7,8-tetra-
 chlorodibenzo-p-dioxin (TCDD).  Toxicol. Appl. Pharmacol.  45: 513-519.

 Birnbaum, L.S., M.M. McDonald,  P.C.  Blair,  A.M.  Clark and M.W. Harris.  1990.
 Differential toxicity of  2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD = in C57BL/6J
 mice congenic at the Ah  locus.  Fund. Appl. Toxicol.  15: 186-200.

 Bombick,  D.W.,  B.V.  Madhukar,  D.Wo  Brewster and  F.  Matusmura.    1985.   TCDD
 (2,3,7,8-tetrachlorodibenzo-p-dioxin)  causes  increases  in  protein  kinases
 particularly protein kinase C in the hepatic plasma membrane of the rat and the
 guinea  pig.  Biochem.  Biophys.  Res.  Commun.   127(1): 296-302.
                                      3-37
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                          DRAFT—DO NOT QUOTE OR CITE
                                                                   I
Bradlaw, J.A., L.H. Garthoff,  N.E.  Hurley and D. Firestone.  1980.  Comparative

induction of  aryl hydrocarbon hydroxylase  activity ±n vitro by analogues of

dibenzo-p-dioxin.  Food. Cosmet. Toxicol.  18: 627-635.
firewater, D.W.  and F. Matsumura.   1984.   TCDD (2,3,7,8-tetrachlorpdibenzo-p-

dioxin) reduces lipiprotein lipase activity in the adipose tissue ofi the guinea

pig.  Biochem. Biophys. Res. Cotnmun. 122: 810-816.                  j
                                                                    I
                                                                    !
                                                                    I
                                                                    I
Brewster, D.W.,  F. Matsumura and T. Akera.   1987.   Effects of 2,3j,7,8-tetra-

chlorodibenzo-p-dioxin on the guinea pig heart muscle.  Toxicol. Appl.! Pharmacol.

89: 408-417.                                                        I
Brewster,  D.W.,  D.W.  Bombick and F. Matsumura.  1988.  Rabbit serum hypertri-

glyceridemia after administration of 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD).

J. Toxicol. Environ.  Health.   26:  495-507.
                                                                   i
                                                                   I
Brouwer, A.   1987.   Interference of 3,4,3-,4'-tetrachlorobiphenyl in vitamin A

 (retinoids) metabolism:  Possible implications for  toxicity and carcjinogenicity

of polyhalogenated aromatic hydrocarbons.   Thesis.                i
                                                                   i
                                                                   I
Brouwer, A. and K.J.  Van den Berg.   1983.  Early decrease in retinoid levels in

mice after exposure to low doses  of polychlorinated biphenyls.  Chemosphere.  12:
                                                                  • i
 555-557.                                                           '

                                                                   i
 Brouwer,  A.  and K.J. Van  den  Berg.   1984.   Early  and differential.decrease in

 natural retinoid levels in C57Bl/Rij  and  DBA/2  mice by 3,4,3',4'-tetrachloro-

 biphenyl.   Toxicol. Appl. Pharmacol.  73:  204-209.                I
                                                                   i

 Brouwer,  A.  and K.J.  Van den Berg.  1986.  Binding  of a metabolite ok 3,4,3',4'-

 tetrachlorobiphenyl  to transthyretin reduces  serum vitamin A transport by
                                                                   1
 inhibiting the formation of  the protein  complex,  carrying both !retinol and

 thyroxin.  Toxicol. Appl. Pharmacol.  85: 301-312.                ,
                                      3-38
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                          DRAFT—DO NOT QUOTE OR CITE

Brouwer, A., K.J.  Van den Berg  and A. Kukler.  1985.  Time and dose responses of
the reduction in retinoid concentrations in C57BL/Rij  and DBA/2 mice induced by
S^S'^'-tetrachlorobiphenyl.  Toxicol. Appl. Pharmacol.  78: 180-189.

Brouwer,  A.,  K.J.   Van  den  Berg,  W.S.  Blaner and  D.S.  Goodman.    1986a.
Transthyretin  (prealbumin) binding of  PCBs, a  model  for  the mechanism of
interference with vitamin A and thyroid hormone metabolism.  Chemosphere.  15:
1699-1706.

Brouwer, A., W.S. Blaner, A. Kukler and K.J. Van den Berg.  1986b.  Interference
of  3,4,3',4'-tetrachlorobiphenyl with the plasma transport protein complex of
vitamin A in rodents leading to a marked reduction in  serum retinol and retinol
binding protein levels.  Toxicol.  Appl. Pharmacol.  (Submitted  for publication)

Brouwer,  A., H.  Hakansson,  A Kukler  and K.J.  van der Berg.    1989.   Marked
alterations in retinoid  homeostasis of Sprague-Dawley rats induced by  a single
i.p.  dose  of  10 pg/kg  of 2,3,7,8-tetrachlorodibenzo-p-dioxin.   Toxicology.
56:  267-283.

BrunstrSm,  B.   1990.   Mono-ortho-chlorinated  chlorobiphenyls:  Toxicity and
induction of 7-ethoxyresorufin O-deethylase  (EROD) activity in chick  embryos.
Arch.  Toxicol.  64:  188-192.

BrunstrSm,   B.  and  L.  Andersson.    1988.    Toxicity  and  7-ethoxyresorufin
O-deethylase-inducing potency of coplanar polychlorinated biphenyls  (PCBs)  in
chick embryos. Arch. Toxicol.   62: 263-266.

 Butler, M.A., M.  Iwasaki, P.P.  Guengerich  and  F.F.  Kadubar.   1989.   Human
 cytochrome  P-450pA   (P1501A2,  the  phenacetin O-deethylase)   is   primarily
 responsible for  the hepatic  3-demethylation of caffeine and N-oxidation  of
 carcinogenic arylamines.  Proc.  Natl. Acad. Sci.  86: 7696-7700.
                                      3-39
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                         DRAFT—DO NOT QUOTE OR CITE               !


Canga, L., R.  Levi and A.B. Rifkind.  1988.  Heart  as a target organ in 2,3,7,8-

tetrachlorodibenzo-p-dioxin toxicity:  Decreased B-adrenergic reapons;iveneBB and
evidence  of  increased  intracellular  calcium.

905-909.
Proc. Nat 1.  Acad.
                                                                    Sci.
                          85:
cantoni,  L.,  M. Salmona  and M. Rizzardini.   1981.   Porphyrogenic  effect of

chronic treatment with 2,3,7,8-tetrachlorodibenzo-p-dioxin in female!rats. Dose-

effect relationship following urinary excretion of porphyrins.  Toxicol. Appl.

Pharmacol.  57: 156-163.



Cantoni,  L.,  D.  Dal  Fiume,  A.  Ferraroli,  M. Salmona, and R. Ruggiejri.  1984a.

Different susceptibility  of mouse tissues to porphyrogenic effect |Of 2,3,7,8-

tetrachlorodibenzo-p-dioxin.  Toxicol. Lett.  20: 201-210.         J

                                                                   ]

Cantoni,  L.,  D. Dal  Fiume,  M.  Rizzardini and R. Ruggieri.   1984b|.   Xn vitro

inhibitory effect on porphyrinogen carboxylase  of  liver  extract^  from  TCDD

treated mice. Toxicol.  Lett.  20:  211-217.                         ,
                                                                   I

                                                                   i
Chapman,  D.E. and C.M.  Schiller.  1985.  Dose-related effects of 2,3,7,8-tetra-

chlorodibenzo-p-dioxin (TCDD)  in C57BL/6J  and  DBA/2J mice.   Toxicol. Appl.
                                                                   i
Pharmacol.  78: 147-157.



Chastain, J.E. and T.L. Pazdernik.  1985.  2,3,7,8-Tetrachlorodibenzo-p-dioxin
                                                                   I
 (TCDD)-induced immunotoxicity.   Int. J.  Immunopharmacol.   7(6): 84J9-856.



 Clark,  D.A.,  G. Sweeney, S. Safe, E.  Hancock, D.G. Kilburn and J. Gauldie.  1983.

 Cellular  and genetic basis for suppression of cytotoxic  T-cell  generation by

 haloaromatic hydrocarbons.  Immunopharmacology.   6:  143-153.

                                                                   i

 DeCaprio, A.P., D.N. McMartin and P.W. O'Keefe, R. Rej, J.B. Silkwprth and LiS.

 Kaminsky. 1986.  Subchronic oral toxicity of 2,3,7,8-tetrachlorodib^nzo-p-dioxin
                                                                   I
 in  the  guinea  pig:  Comparisons  with   a PCB-containing transformer  fluid

 pyrolysate.  Fundam. Appl. Toxicol.  6:  454-463.                  :

                                      3-40                         [    08/11/92

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                          DRAFT—DO WOT QUOTE  OR CITE

Ebner, K., Brewater, D.W. and  Matsumura,  F.   1988.   Effects of 2,3,7,8-tetra-
chlorodibenzo-p-dioxin on serum insulin  and  glucose levels  in the  rat.   J.
Environ. Sci. Health.  B23: 427-438

Elder,  G.H.  and  D.M.  Sheppard.     1982.    Immunoreactive  uroporphyrinogen
decarboxylase is unchanged  in  porphyria caused by TCDD and hexachlorobenzene.
Biochem. Biophys. Res. Comm.   109:  113-120.

Elder,  G.H.,  J.O.  Evans and S.A.  Matlin.   1976.  The effect of porphyrogenic
compound,  hexachlorobenzene,  on  the  activity  of  hepatic  uroporphyrinogen
decarboxylase in the rat.   Clin. Sci.  Mol. Med.   51:  71-80.

Elder,  D.G.,  G.B.  LEE and  J.A.  Tovey.   1978.   Decreased activity of  hepatic
uroporphyrinogen decarboxylase in sporadic porphyria cutanea tarda.  N. Engl. J.
Med.   299:  274-278.

Firestone, D.  1973. Etiology  of chick edema disease.  Environ. Health Perspect.
5:  59-66.

FlodstrSm,  S.,  L.  Busk, T. Kronevi  and U.G. Ahlborg.   1991.   Modulation of
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) and phenobarbital-induced promotion
of hepatocarcinogenesis in rats by the type  of  diet  and  vitamin A deficiency.
Fundam. Appl. Toxicol.  16: 375 -391.

 Gasiewicz,  T.A. and R.A. Neal.  1979. 2,3,7,8-tetrachlorodibenzo-p-dioxin tissue
 distribution, excretion, and effects on clinical chemical parameters in guinea
 pigs.  Toxicol. Appl. Pharmacol.  51:  329-339.

 Gasiewicz, T.A. and G. Rucci.  1984.  Cytosolic receptor for 2,3,7,8-Tetrachloro-
 dibenzo-p-dioxin.   Evidence  for  a homologous  nature among  various mammalian
 species.  Mol, Pharmacol.  26: 90-98.
                                      3-41
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                          DRAFT—DO NOT QUOTE OR  CITE               '

                                                                   i

Gasiewicz, T.A., G.  Rucci, E.G. Henry and R.B.  Baggs.  1986.  Changes in hamster


hepatic  cytochrome  P-450,  ethoxycoumarin o-deethylase,  and  reduced  NAD(P):


Menadion© oxidoreductase following treatment with 2,3,7,8-tetrachlorodibenzo-p-


dioxin. Partial  dissociation  of temporal  and  dose-response relationships from


elicited toxicity.  Biochem.  Pharmacol.  35: 2737-2742.            j
                                                                   i

                                                                   i

Gayer, H.J.,  I.  Scheuntert, K. Rapp et al.   1990.   Correlation between acute


toxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) and total body Ifat content

                                                                   I
in mammals.  Toxicology.   65:  97-107.
                                                                   i
                                                                   !
                                                                   I

Gierthy, J.F. and D. Crane.   1985a.  In vitro bioassay for dioxinlike  activity


based on alterations in epithelial cell proliferation and morphology.  Fundam.


Appl. Toxicol.   5:  754-759.                                        j

                                                                   i

Gierthy,  J.F. and  D.  Crane.   1985b.   Development of in  vitro bioassays  for


chlorinated dioxins and dibenzofurans.  In: Chlorinated dioxins and dibenzofurans


in  the  total environment II, L.H.  Keith,  C.  Rappe  and G.  Chovidhury,  Ed.


Butterworth Publishers,  Boston, MA.                               ;
                                                                   I
                                                                   i


Gierthy,  J.F.,  D. Crane  and  G.D.  Frenkel.   1984.   Application of an  In vitro


keratinization   assay  to extracts  of  soot from a fire  in a polychlorinated


biphenyl-containing transformer.   Fundam.  Appl.  Toxicol.   4:  1036-1041.
 Goldstein, J.A.,  P.  Linko and H.  Bergman.  1982.  Induction of porphyria in the

 rat by chronic versus acute  exposure  to  2,3,7,8-tetrachlorodibenzo-p-dioxin.


 Biochem.  Pharmacol.   31: 1607-1613.
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                         DRAFT—DO  NOT QUOTE OR CITE

Goldstein, J.A., F.H.  Lin,  S.J. Stohs et al.   1990.   The effects  of TCDD on
receptors  for  epidermal growth factor,  glucocorticoid,  and estrogen  in Ah-
responsive and -nonresponsive congenic mice and the effects of TCDD on estradiol
metabolism in  a liver tumor promotion model in female  rats.   In:  Mouse Liver
Carcinogenesis:  Mechanisms  and Species  Comparisons.   Alan  R.,   Liss,   Inc.
p. 187-202.

Gorski, J.R. and K. Rozman.   1987.  Dose-response and time course of  hypothyrox-
inemia and hypoinsulinemia  and  characterization of  insulin hypersensitivity  in
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)-treated rats. Toxicol.  44: 297-307.

Gorski,  J.R.,  L.W.D. Weber  and K.  Rozman.   1990.  Reduced  gluconeogenesis  in
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)-treated rats.  Arch. Toxicol.   64:
66-71.

Gottlicher,  M., P.  Cikryt and F.J.  Wiebel.   1990.   Inhibition of  growth  by
 2,3,7,8-tetrachlorodibenzo-p-dioxin in 5L rat hepatoma cells is associated with
 the presence of Ah receptor. Carcinogenesis.   11(12), 2205-2210.

 Greig,  J.B.,  G. Jones,  W.H. Butler and  J.M.  Barnes.   1973.   Toxic effects of
 2,3,7,8-tetrachlorodibenzo-p-dioxin.  Food Cosmet. Toxicol.   11: 585-595.

 Hahn, M.E., T.A. Gasiewicz, P.  Linko and J.A. Goldstein.  1988.  The role of the
 Ah locus in hexachlorobenzene-induced porphyria: Studies in the congenic C57BL/6J
 mice.  Biochem. J.   254: 245-254.

 Hanberg,  A,  M. St&hlberg,  A.  Georgellis,  C.  de Wit and  U.G.  Ahlborg.   1991.
 Swedish  dioxin survey:  Evaluation  of  the  H-4-II  E  bioassay  for  screening
 environmental samples for dioxin-like enzyme induction..  Pharmacol.  Toxicol.
  (in press)
                                       3-43
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                          DRAFT—DO  NOT QUOTE  OR  CITE
Harris, M.W., J.A. Moore, J.G. Vos  and  B.N.  Gupta.   1973.   General
biological
effects of  TCDD  in laboratory animals.   Environ.  Health Perspect.|,  Exp.   5:
101-109.
Hayes, K.C.  1971.  On the pathophysiology of vitamin A deficiency.
29: 3-6.
Nutr. Rev.
Hebert, C.D.,  M.W.  Harris, M.R. Elwell  and L.S. Birnbaum.   1990aj.   Relative
toxicity  and tumor  promoting ability  of 2,3,7,8-tetrachlorodibenzo-p-dioxin
(TCDD),  2,3,4,7,8-pentachlorodibenzofuran  (PCDF)  and 1,2,3,4,7,8-jhexachloro-
dibenzofuran  (HCDF).  Toxicol. Appl. Pharmacol.  102:  362-377.      [
Hebert,  C.D.,  L. Cao and  L.S.  Birnbaum.   1990b.   Inhibition of high-density
growth arrest  in human  squamous  carcinoma cells by  2,3,7,8-tetrachlorodibenzo-
p-dioxin (TCDD).  Carcinogenesis.   lit  1335-1342.
Hebert, C.D., Q.L.  Cao  and L.S.  Birnbaum.   1990c.   Role of transforming growth
factor beta in the  proliferative effect  of  2,3,7,8-tetrachlorodibenzo-p-dioxin
on  human  sguamous carcinoma cells.   Cancer  Res.   50:  7190-7197.    |
 Henck,  J.M.,  M.A.  New, R.J. Kociba and K.S. Rao.   1981.   2,3,7,8-tetrachloro-
 dibenzo-p-dioxin:  Acute oral toxicity in hamsters.   Toxicol.  Appl4  Pharmacol.
 59t  405-407.
 Hochstein,  J.R., R.J.  Aulierich and S.J. Bursian.   1988.  Acute  toxicity of
 2,3,7,8-tetrachlorodibenzo-p-dioxin to mink.  Arch.  Environ.  Contain.  Toxicol.
 17:  33-27.

 Hook,  G.E.R.,  J.K. Haseman and G.W. Lucier.  1975.  Induction and suppression of
 hepatic and extrahepatic microsomal foreign-compound-metabolizing enzyme systems
 by 2,3,7,8-tetrachlorodibenzo-p-dioxin.  Chem.-Biol. Interact.  10p 199.
                                      3-44
   08/11/92

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                          DRAFT—DO NOT  QUOTE OR CITE

Hudson, L.G., R. Shaikh,  W.A. Toscano and W.F.  Greenlee.   1983.  Induction of
7-ethoxycoumarin-O-deethylase activity  in cultured human  epithelial cells by
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD). Evidence for TCDD receptor. Biochem.
Biophys. Res. Commun.  115: 611-617.

Hudson, L.G., W.A.  Toscano, Jr. and W.F.  Greenlee.  1985. Regulation of epidermal
growth factor binding in a human keratinocyte cell  line by  2,3,7,8-tetrachloro-
dibenzo-p-dioxin.  Toxicol. Appl.  Pharmacol,  77: 251-259.

Hudson, L.G., W.A.  Toscano and W.F. Greenlee.  1986.  2,3,7,8-Tetrachlorodibenzo-
p-dioxin  (TCDD) modulates epidermal growth factor  (EGF) binding to basal cells
from  a human keratinocyte cell  line.  Toxicol.  Appl. Pharmacol.   82: 481-492.

Hakansson,  H.  and A.  Hanberg.   1989.   The  distribution of  [ 14C]-2,3,7,8-
tetrachlorodibenzo-p-dioxin  (TCDD) and  its effect  on  vitamin  A  content  in
parenchymal  and stellate cells  of rat liver.  J. Nutr.  119:  573-580.

Hikansson, H., L. Johansson, U.G.  Ahlborg, R.W.  Moore and R.E. Peterson.  1989a.
Hepatic  vitamin A storage in  relation to paired feed  restriction and TCDD-
treatment.   Chemosphere.  19(1-6): 919-920.

Hakansson,  H., L. Johansson,  E.  Manzoor  and U.G. Ahlborg.  1989b.   2,3,7,8-
tetrachlorodibenzo-p-dioxin  (TCDD)-induced  alterations   in   the   vitamin  A
homeostasis and in the 7-ethoxyresorufin O-deethylase  (EROD)-activity  in Sprague-
Dawley rats and Hartley guinea pigs.   Chemosphere.  18(1-6): 299-305

Hikansson,   H.,  H. Hanberg  and  U.G.  Ahlborg.    1989c.    The  distribution of
 [14C]2,3,7,8-tetrachlorodibenzo-p-dioxin  (TCDD) between  parenchymal  and  non-
 paremchymal rat hepatic cells and its effect on the  vitamin A content of these
 cells.  Chemosphere.  18: 307-312.
                                      3-45
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                          DRAFT—DO NOT QUOTE OR CITE

Hakansson, H.,  U.G.  Ahlborg, L.  Johansson and H.  Poiger.   1990.   Vitamin A
storage in rats subchronically exposed to PCDDs/PCDFs.  Chemosphere^.  20(7-9):
1147-1159.
                                                                   i
                                                                   1
Hikansson H,  L. Johansson,  E.  Manzoor  and U.G.  Ahlborg.   1991.  I Effects of
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)  on  the vitamin A status^ of Hartley
guinea pigs,  Sprague-Dawley rats, C57B1/6 mice,  DBA/2 mice, and Golden Syrian
hamsters.  J. Nutr. Sci.  Vitaminol.  37:  117-138.
                                                                   i
Hikansson, H.,  L.  Johansson, E.  Manzoor  and U.G.  Ahlborg.   1992. [ Effects of
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)  on 7-ethoxyresorufin-O-deethylase
activity  in Hartley guinea pigs, Sprague-Dawley rats,  C57B1/6  mice,  DBA/2 mice,
and Golden Syrian  hamsters.   Manuscript  in preparation.            i
                                                                   t
                                                                   i-
                                                                   i
Jaiswal,  A.K.,  D.W.  Nebert and H.W.   Eilsen.    1985.   Comparison  of  aryl
hydrocarbon  hydroxylase and acetanilide  4-hydroxylase  induction  by polycyclic
aromatic  compounds in  human and  mouse cell lines.   Biochem. Pharmacol.   34:
2721-2731.

Jones,  E.L.  and H. Krizek.   1962.   A technic  for testing acnegenic potency in
 rabbits,  applied to the potent acnegen, 2,3,7,8-tetrachlorodibenzo-p-dioxin.  J.
 Invest.  Dermatol.   39: 511-517.                                   j
                                                                   i
                                                                   I
                                                                   I
 Jones,  G. and J.B.Greig.   1975.  Pathological changes in the liver of mice given
                                                                   i
 2,3,7,8-tetrachlorodibenzo-p-dioxin.  Experientia.  31: 1315-1317.J
                                                                   i
                                                                   i
 Jones, K.G. and G.D. Sweeney.  1980. Dependence  of the porphyrogepic effect of
 2,3,7,8-tetrachlorodibenzo(p)dioxin upon  inheritance  of  aryl , hydrocarbon
 hydroxylase  responsiveness.  Toxicol. Appl. Pharmacol.  53: 42-49.
 Kawamoto,  T.,  F. Matsumura,  B.V. Madhukar  and D.W. Bombick.   1989.  Effects of
 TCDD on the EGF receptor of XB mouse keratinizing epithelial cells.  J.  Biochem.
 Toxicol.   4:  173-182.                                             j
                                       3-46                         i     08/11/92

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                          DRAFT—DO NOT QUOTE OR CITE

Kelling, O.K.,  B.J. Christian, S.L. Inborn and R.E. Peterson.  1985.  Hypophagia-
induced  weight loss  in  mice,  rats,  and guinea pigs  treated  with 2,3,7,8-
tetrachlorodibenzo-p-dioxin.  Fundam. Appl.  Toxicol.  5: 700-712.

Kelling, C.K.,  L.A.  Menahan and R.E.  Peterson.  1987.  Effects of  2,3,7,8-tetra-
chlorodibenzo-p-dioxin  treatment  on mechanical  function  of the  rat  heart.
Toxicol. Appl. Pharmacol.   91: 497-501.

Keys, B., M. Hlavinka,  G.  Mason  and S.  Safe.  1985.   Modulation  of rat  hepatic
microsomal testosterone hydroxylases by 2,3,7,8-tetrachlorodibenzo-p-dioxin and
related toxic  isostereomers.   Can.  J.  Pharmacol.  63: 1537-1542.

Kimmig,  J. and K.H.  Schulz.  1957.   Chlorierte aromatische zyklische Sther als
ursache der  sogenannten chlorakne.  Die Naturwissenschaft.   ??: 337-338.

Kitchin, K.T.  and J.S. Woods.   1979.  2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)
effects on  hepatic  microsomal  cytochrome  P-448-mediated enzyme  activities.
Toxicol. Appl. Pharmacol.  47: 537-546.

 Kleeman, J.M., R.W. Moore  and R.E.  Peterson.   1990.  Inhibition of  testicular
 steroidogenesis in  2,3,7,8-tetrachlorodibenzo-p-dioxin-treated  rats:  Evidence
 that the key lesion occurs prior to or  during pregnenolone formation.  Toxicol.
 Appl. Pharmacol.  106: 112-125.

 Knutson, J.C. and  A.  Poland.   1980a.   2,3,7,8-tetrachlorodibenzo-p-dioxin:
 Failure to demonstrate toxicity in twenty-three cultured cell types.  Toxicol.
 Appl. Pharmacol.  54:  377-383.

 Knutson, J.C.  and A. Poland.   1980b.  Keratinization of  mouse teratoma cell line
 XB  produced  by 2,3,7,8-tetrachlorodibenzo-p-dioxin:  An  in vitro model  of
 toxicity.  Cell, "22: 27-36.
                                       3-47
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                          DRAFT—DO NOT QUOTE OR CITE
                                                                   t
Knutson, J.C. and A. Poland.   1982.   Response of murine epidermis to 2,3,7,8-
tetrachlorodibenzo-p-dioxin: Interaction of the Ah and hr Loci. Cell.  30: 225-
234.                                                               !
Kociba, R.J., P.A.  Keeler,  C.N.  Park and P.J.  Gehring.  197S.  2,3,7,8-tetra-
chlorodibenzo-p-dioxin (TCDD): Results of a 13-week oral toxicity study in rats.
Toxicol. Appl. Pharmacol.   35: 553-574.                            '
Kociba, R.J., D.G. Keyes, J.E.  Beyer et al.  1978.  Results of a two year chronic
toxicity and oncogenicity study of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)  in
                                                                   i
rats.  Toxicol.  Appl.  Pharmacol.   46: 279-303.

Kociba, R.J., D.G. Keyes, J.E. Beyer, R.M. Carreon and P. Gehring. JL979.  Long-
terra  toxicologic studies  of  2,3,7,8-tetrachlorodibenzo-p-dioxin  (TCDD)   in
laboratory animals.   Ann. N.Y. Acad.  Sci.   320:  397-404.          j
                                                                   i
                                                                   i
Korte, M., R. Stahlmann and D. Neubert.  1990.  Induction of hepatic monooxyge-
nases in female rats and offspring in correlation with TCDD tissue concentrations
 after single treatment during pregnancy.  Chemosphere.  20: 1193-1198.

 Kruger,  N., B.  Neubert, H.  Helge and  D.  Neubert.  1990.  Inductionjof caffeine-
 demethylations by 2,3,7,8-TCDD in  marmoset monkeys measured with  a 14CO2-breath
                                                                   t
 test.  Chemosphere.  20: 1173-1176.                               [

 Lakshman, M.R., B.S. Campbell, S.J. Chirtel and N. Ekarohita.  1988.  Effects of
 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on de novo fatty acid and cholesterol
 synthesis in the rat.   Lipids.  23(9):  904-906.                   -;
                                                                   i
 Lakshman, M.R.,  S.J. Chirtel, L.L. Chambers and P.J. Coutlakis.  1989.  Effects
 of  2,3,7,8-tetrachlorodibenzo-p-dioxin  on lipid synthesis and lipogenic enzymes
 in  the rat.  J.  Pharmacol. Exp. Ther.   248(1):  62-66.
                                       3-48
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                          DRAFT—DO NOT QUOTE OR CITE

Lakahman, M.R.,  P. Ghosh  and S.J. Chirtel.    1991.   Mechanism of  action of
2,3,7,8-tetrachlorodibenzo-p-dioxin  on  intermediary metabolism  in  the rat.
J. Pharmacol. Exp. Ther.  258(1): 317-319.

Lans, M.C.,  E. Klasson-Wheeler, M. Willemsen, E.  Meussen, S. Safe and A. Brouwer.
1992.    Structure-dependent,  competetive  interaction  of hydroxy-polychloro-
biphenyls, -polychlorodibenzo-p-dioxins and -polychlorodibenzofurans  with human
tranathyrethrin.   Chem.-Biol. Interact.   (Manuscript in preparation)

Lentnek, M., O.W. Griffith and A.B. Rifkind.  1991.  2,3,7,8-Tetrachlorodibenzo-
p-dioxin increases reliance on  fats  as a  fuel source  independently of diet:
Evidence that diminished carbohydrate supply contributes to dioxin  lethality.
Biochem.  Biophys.  Res. Commun.   174(3):  1267-1271.

Liem, H.H., U. Muller-Eberhard and E.F. Johnson.  1980.  Differential induction
by  2,3,7,8-tetrachlorodibenzo-p-dioxin of multiple forms of rabbit  microsomal
cytochrome  P-450:  Evidence for tissue specificity.   Mol.  Pharmacol.   18: 565.

Lin, F.H.,  S.J.  Stohs, L.S. Birnbaum, G. Clark,  G.W.  Lucier and J.A.  Goldstein.
1991a.  The effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on the hepatic
estrogen and glucocorticoid receptors in congenic  strains of Ah responsive  and
Ah  nonresponsive C57BL/6J mice.   Toxicol.  Appl. Pharmacol.  108:  129-139.

Lin,  F.H.,  G. Clark,  L.S. Birnbaum,  G.W.  Lucier  and  J.A. Goldstein.   1991b.
Influence of the Ah locus on the effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin
on  the  hepatic epidermal growth  factor receptor.  Mol.  Pharmacol.  39: 307-313.

Lucier, G.W.,  B.R. Sonawane, O.S. McDaniel and G.E.R. Hook.   1975.   Postnatal
 stimulation of  hepatic microsomal enzymes  following administration  of  TCDD to
pregnant rats.   Chem.-Biol. Interact.  11: 15-26.
                                      3-49
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                          DRAFT—DO NOT QUOTE OR CITE

Lucier, G.W., A. Tritcher, J. Goldsworthy et al.  1991.   Ovarian hormones enhance
2,3,7,8-tetrachlorodibenzo-p-dioxin-mediated increases in cell proliferation and
preneoplastic foci in  a  two-stage model  for rat hepatocarcinogenesis.  Cancer
Res.  51, 1391-1397.                                               i
                                                                   I

Luster, M.I., G.A. Boorman, J.H. Dean et al.  1980.  Examination  of tone marrow,
immunologic  parameters and  host  susceptibility following  pre- and  postnatal
exposure to 2,3,7,8-tetrachlorodibenzo-p-dioxin  (TCDD). Int. J. Immuriopharmacol.
2: 301-310.                                                        |
                                                                   i

Luster, M.I., L.H. Hong, G.A. Boorman et al.  1985.  Acute myelotoxic  responses
in mice exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD).  Toxicol. Appl.
                                                                   [
Pharmacol.   81: 156-165.                                           !
 Mably,  T.A.,  R.W.  Moore,  D.L.  Bjerke  and  R.E. Peterson.   1991.   The  male
 reproduction  system  is  highly  sensitive to in  utero  and  lactational  TCDD
 exposure.  In:  Banbury Report: Biological basis for risk assessment of dioxins and
 related compounds,  Vol.  35, M.A. Gallo,  J. Scheuplein and K.A. van ider Heijden,
 Ed.   Cold Spring Harbor Laboratory,  p. 69-78.                     |

 Mably,  T.A.,  R.W.  Moore, R.W. Goy and R.E. Peterson.   1992a.   in  utero and
 lactational  exposure  of  male  rats  to  2,3,7,8-tetrachlorodibenzo-p-dioxin:
 1. Effects on androgenic status.  Toxicol. Appl. Pharmacol.  114:  97-107.

 Mably,  T.A.,  R.W.  Moore,  R.W. Goy and R.E. Peterson.   1992b.   In  utero and
 lactational  exposure  of  male  rats  to  2,3,7,8-tetrachlorodibenzo-p-dioxin:
 2. Effects on sexual behavior and the regulation of luteinizing hormone secretion
                                                                   i
 in adulthood.  Toxicol. Appl. Pharmacol.  114:  108-117.           |
 Mably, T.A., D.L. Bjerke, R.W. Moore,  A.  Gendron-Fitzpatrick and RjE. Peterson.
 1992c.  In  utero and  lactational exposure of male rats to 2,3,7,8-tetrachloro-
 dibenzo-p-dioxin:  3.  Effects on spermatogenesis  and reproductive capability.
 Toxicol. Appl.  Pharmacol.   114: 118-126.                          [
                                       3-50                              08/11/92

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                          DRAFT—DO NOT QUOTE OR CITE






Madhukar, B.V.,  D.W.  Brewster and  F.  Matsumura.   1984.   Effects of In vivo-



administered 2,3,7,8-tetrachlorodibenzo-p-dioxin on receptor binding of epidermal



growth factor  in the hepatic  plasma membrane of rat,  guinea pig/  mouse, and



hamster.  Proc. Natl. Acad. Sci. USA.   81: 7407-7411.







Mason, G., K. Parrel1, B. Keys, J.  Piskorska-Pliszczynska,  L.  Safe and  S. Safe.



1986.   Polychlorinated  dibenzo-p-dioxins: Quantitative in vitro and  in  vivo



structure-activity relationships.   Toxicology.  41:  21-31.







Max, S.R., and E.K. Silbergeld.  1987.  Skeletal muscle glucocorticoid  receptor



and glutamine synthetase activity  in the  wasting  syndrome  in  rats treated  with



2,3,7,8-tetrachlorodibenzo-p-dioxin.   Toxicol.  Appl.  Pharmacol.   87: 523-527.







McConnell, E.E.  1980.  Acute and chronic toxicity, carcinogenesis, reproduction,



teratogenesis and mutagenesis in animals.  In; Halogenated Biphenyls,  Perphenyls,



Naphthalenes,  Dibenzodioxins,   and Related  Products,  Kimbrough,   R.D.,  Ed.



Elsevier Science Publ.,  Amsterdam,   p. 109-150.







McConnell,  E.E., J.A. Moore  and D.W.  Dalgard.   1978a.  Toxicity  of  2,3,7,8-



tetrachlorodibenzo-p-dioxin in rhesus monkeys (Jfacaca mulatta)  following a single



oral  dose.   Toxicol.  Appl.  Pharmacol.  43: 175-187.







McConnell,  E.E.,  J.A.  Moore,  J.K.  Haseman and  M.W. Harris.   1978b.   The



comparative toxicity of  chlorinated dibenzo-p-dioxins in mice and guinea pigs.



Toxicol. Appl.  Pharmacol.  44: 335-356.







McNulty, W.P.  1977.  Toxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin for rhesus



monkeys: Brief report.  Bull. Environ. Contam.  Toxicol.  18:  108-109.







McNulty, W.P.  1984.  Fetotoxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)



 for rhesus macaques (Macaca mulatta).  Am. J. Primatol.  6:  41-47.
                                      3-51
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                                                                   [
Mittler, J.C., N.H. Ertel, R.X. Peng,  C.S.  Yang and T. Kiernan.  1984.  Changes
in testosterone hydroxylase activity in rat testis following administration of
2,3,7,8-tetrachlorodibenzo-p-dioxin.  Ann. N.Y. Acad. Sci.  438: 645-648.

Moore,  R.W.  and R.E.  Peterson.  1985.   Enhanced catabolism and elimination of
androgens do not cause the androgenic deficiency in 2,3,7,8-tetrachlorodibenzo-p-
dioxin-treated rats.   Fed. Proc.   44:  518.                         i

Moore,  J.A.,  E.E.  McConnell,  D.W.  Dalgard  and M.W. Harris.   1979.   Comparative
toxicity of  three  halogenated dibenzofurans  in guinea  pigs,  mice|  and  rhesus
monkeys.  Ann. N.Y. Acad. Sci.  p. 151-163.

Moore,  R.W.,  C.L. Potter, H.M. Theobald, J.A.  Robinson and R.E. Petejrson.  1985.
Androgenic deficiency in male rats treated with 2,3,7,8-tetrachlorodibenzo-p-
dioxin.  Toxicol. Appl. Pharmacol.  79: 99-111.

Moore,   R.W.,  C.R. Jefcoate, and R.E. Peterson.   1991.  2,3,7,8-Jretrachloro-
 dibenzo-p-dioxin inhibits steroidogenesis in the  rat testis by inhibiting the
 mobilization of cholesterol  to cytochrome P450SCC1.   Toxicol.  Appl;. Pharmacol.
 109: 85-97.

 Nagayama,  J.,  C.  Kiyohara,  Y. Masuda and M.  Kuratsune.   1985.    Genetically
 mediated induction of aryl hydrocarbon hydroxylase activity in human lymphoblas-
 toid  cells  by polychlorinated dibenzofuran  isomers  and 2,3,7,84tetrachloro-
 dibenzo-p-dioxin.  Arch.  Toxicol. 56: 230-235.

 Neal,  R.A.,  J.R.  Olson,  T.A. Gasiewicz and L.E. Geiger.   1982.    The  toxico-
 kinetics  of 2,3,7,8-tetrachlorodibenzo-p-dioxin  in mammalian  systems.   Drug
 Metab. Rev.   13:  355-385.

 Nebert, D.W.  1989.   The Ah locus:  Genetic differences in  toxicity,  cancer,
 mutation and birth defects.   Crit. Rev.  Toxicol.   20:  137-152.
                                       3-52
                                                                        08/11/92

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                          DRAFT—DO NOT QUOTE OR CITE






Neubert, D.  1991.  Animal data on the toxicity of TCDD and special aspects of



risk assessment.  Presented at a WHO consultation of tolerable daily intake of



PCDDs and PCDFs from food, Bilthoven, The Netherlands, 1990.







Niwa, A.,  K.  Kumaki and D.W. Nebert.   1975.   Induction  of aryl hydrocarbon -



hydroxylase activity in various  cell cultures by 2,3,7,8-tetrachlorodibenzo-p-



dioxin.  Mol. Pharmacol.  11:  399-408.







Nohl, H.,  D.  De Silva  and K.-H. Summer.  1989.  2,3,7,8-Tetrachlorodibenzo-p-



dioxin induces oxygen activation associated with cell respiration.  Free Radic.



Biol. Med.  6:  369-374.







Norback,  D.H. and  J.R.  Allen.   1973.   Biological  responses  of the nonhuman



primate,  chicken, and  rat to  chlorinated dibenzo-p-dioxin  ingestion.  Environ.



Health Perspect.  5: 233-240.







NTP  (National Toxicology  Program).   1982.   Carcinogenesis  bioassay of 2,3,7,8-



tetrachlorodibenzo-p-dioxin  (CAS No. 1746-01-6)  in Osborne-Mendel rat and B6C3F1



mice (gavage study).   NTP Tech.  Kept. Ser.  109.   DHHS,  PHS,  NIH, Research



Triangle Park.







NTP  (National Toxicology  Program).   1982.   Carcinogenesis  Bioassay of 2,3,7,8-



tetrachlorodibenzo-p-dioxin  (CAS No. 1746-01-6) in Osborne-Mendel Rats and B6C3F1



Mice (Gavage  Study).   Govt.  Reports Announce.  Index  (GRASI),  Issue 11,  1981.







Okey, A.B. and  L.M. Vella.  1982.  Binding of 3-methylcholanthrene and 2,3,7,8-



tetrachlorodibenzo-p-dioxin to a common Ah receptor site in  mouse and rat  hepatic



cytosols.  Eur. J.  Biochem.   127: 39-47.







Olson,  J.R.,  M.A. Holscher and  R.A.  Neal.   1980.   Toxicity  of  2,3,7,8-tetra-



 chlorodibenzo-p-dioxin in the golden Syrian hamster.  Toxicol. Appl.  Pharmacol.



 55:  67-78.
                                      3-53
08/11/92

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                          DRAFT—DO NOT QUOTE OR CITE              ,


Osborne, R.  and W.F. Greenlee.  1985.  2,3,7,8-tetrachlorodibenzo-p-dIoxin (TCDD)

enhances terminal differentiation of cultured human epidermal cells.  Toxicol.
                                                                  [
Appl. Pharmacol.  77: 434-443.



Peterson, R.E., B.V. Madhukar, K.H. Yang and F. Matsumura.  1979a.  DepreBBion

of adenosine  triphosphatase activities in isolated liver surface membranes of

2,3,7,8-tetrachlorodibenzo-p-dioxin-treated rats:  Correlation with effects on

ouabain biliary excretion and bile  flow.  J. Pharmacol. Exp. Ther.  210: 275-210.



Peterson, R.E.,  N. Hamada, K.H. Yang  and  B.V.  Madhukar.   1979b. !  Reversal of

2,3,7,8-Tetrachlorodibenzo-p-dioxin-induced   depression  of  ouabain  biliary

excretion by pregnenolone-16)7C(-carbonitrile  and spironolactone  in isolated

perfused rat  livers.   Toxicol. Appl.  Pharmacol.  50:  407-416.



Peterson, R.E., M.D. Seefeld,  B.J.  Christian,  C.L.  Potter, K.  Rolling and R.

Keesey.  1984.   The  wasting syndrome  in 2,3,7,8-tetrachlorodibenzo-p-dioxin

toxicity: Basic features and their  interpretation. In:  Banbury Reporf: Biological

Mechanisms  of Dioxin Action, Vol 18, A Poland and  R Kimbrough, Ed.  Cold Spring

 Harbor Laboratory,  p. 291-308.



 Pliiess, N., H.  Poiger,  C.  Hohbach, M. Suter and C.  Schlatter.  1988;.  Subchronic

 toxicity of  some  chlorinated dibenzofurans  (PCDFs) and a mixture of PCDFs and

 chlorinated  dibenzodioxins  (PCDDs) in rats,  chemosphere.  17,  937-984



 Pluess, N, H. Poiger, C. Hohbach,  M. Suter and  C.  Schlatter.  1988.  Subchronic

 toxicity of 2,3,4,7,8-pentachlorodibenzofuran (PeCDF) in rats.  Chemosphere. 17:

 1099-1110.
                                                                  i
                                                                  r
                                                                  i

 Pohjanvirta, R.   1990.  TCDD resistance is inherited as an autosomal dominant

 trait  in the rat.   Toxicol.  Lett.   50:  49-56.
                                       3-54
08/11/92

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                          DRAFT—DO NOT QUOTE OR CITE

Pohjanvirta, R.  1991.  Studies on the mechanism of acute toxicity of 2,3,7,8-
tetrachlorodibenzo-p-dioxin  (TCDD)  in rats.   Publication of  National Public
Health Institute, Helsinki, Finland.  No. Al/1991.

Pohjanvirta, R.  and J.  Tuomisto,  J.   1987.   Han/Wistar rats are exceptionally
resistant to TCDD.  Arch. Toxicol.  11:344-347.

Pohjanvirta, R., R. Juvonen,  S.  KSreralampi,  H. Raunio and J. Tuomisto.   1988.
Hepatic Ah-receptor levels and the effect of 2,3,7,8-tetrachlorodibenzo-p-dioxin
(TCDD) on hepatic  microsomal monooxygenase activity in a TCDD-suspectible  and
-resistant  rat strain.  Toxicol.  Appl. Pharmacol.  92: 131-140.

Pohjanvirta, R., L. Tuomisto and J. Tuomisto.   1989.  The central nervous system
may be involved  in TCDD toxicity.   Toxicology.   58:  167-174.

Pohjanvirta, R., H.  Hakansson, R. Juvonen and J. Tuomisto.  1990.   Effects of
TCDD  on vitamin A status and  liver  microsomal enzyme  activities  in  a  TCDD-
susceptible and  a  TCDD-resistant rat  strain.   Food Chem.  Toxic.   28: 197-203.

Poiger,  H.  and C.H.  Schlatter.  1980.  Influence of  solvents and adsorbents on
dermal and  intestinal absorption of TCDD.  Food. Cosmet.  Toxicol.  18: 477-481.

Poland,  A.  and E. Glover.  1973.   Chlorinated dibenzo-p-dioxins: Potent inducers
of 6-aminolevulinic  acid  synthetase  and aryl hydrocarbon hydroxylase.   II.  A
study of the structure-activity relationship.  Mol.  Pharmacol.  9:  736-747.

Poland,  A.  and  E. Glover.   1974.   Comparison of 2,3,7,8-tetrachlorodibenzo-p-
dioxin,  a  potent  inducer of aryl hydrocarbon  hydroxylas.e,  with 3-methylchol-
 anthrene.  Mol.  Pharmacol.  10: 349-359.

 Poland,  A.  and  J.C.  Knutson.   1982.   2,3,7,8-Tetrachlorodibenzo-p-dioxin and
 related halogenated  aromatic hydrocarbons:  Examination  of  the mechanisms of
 toxicity.  Ann.  Rev. Pharmacol. Toxicol.  22: 517-554.
                                      3-55                             08/11/92

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                          DRAFT—DO  NOT QUOTE OR CITE

Poland, A.,  E.  Glover and A.S. Kende.   1976.   Stereospecific,  high affinity
binding of 2,3,7,8-tetrachlorodibenzo-p-dioxin by hepatic cytoaol. Evidence that
the binding species is receptor for induction of aryl hydrocarbon hydroxylaae.
J. Biol. Chem.  251: 4936-4946.

Potter, C.L., L.A. Menahan and R.E. Peterson.  1986.  Relationship of alterations
in energy metabolism to  hypophagia in  rats  treated with 2,3,7,8-tetrachloro-
dibenzo-p-dioxin.  Fundam. Appl.  Toxicol.  6: 89-97.

Puhvel, S.M., M.  Sakamoto, D.C. Ertl and R.M. Reisner.  1982.   Hairless mice as
models for chloracne: A study of cutaneous changes induced by topical application
of established  chloracnegens.   Toxicol.  Appl. Pharmacol.  64:  492-503.

Puhvel, S.M., M.J. Connor and M.  Sakamoto.  1991.  Vitamin A deficiency and the
induction of  cutaneous  toxicity  in  murine skin by  TCDD.    Toxicol.  Appl.
Pharmacol.   107,  106-116.

Quilley,  C.P. and A.B. Rifkind.  1986.  Prostaglandin release by the chick embryo
 heart is  increased by 2,3,7,8-tetrachlorodibenzo-p-dioxin and by other cytochrome
 P-448 inducers.   Biochem. Biophys. Res. Commun.  136(2): 582-589.

 Rifkind, A.B., M. Gannon and S.S. Gross.  1990.  Arachidonic acid metabolism by
 dioxin-induced cytochrome P-450:  A new hypothesis on the role of P-J450  in dioxin
 toxicity.   Biochem. Biophys. Res.  Commun.  172(3): 1180-1188.    j

 Roberts, L.  1991.  Dioxin  risks revisited.  Science.  251: 624-626.
                                                                  I
 Rozman,  K., L.W.D.  Weber,  B.  Pfeiffer et al.   1990.  Evidence  fob  an indirect
 mechanism of  acute toxicity of 2,3,7,8-tetrachlorodibenzo-p-dibxin   in  rats.
  Organohalogen  compounds, Vol.  1.  Dioxin 90.
                                       3-56
                                                                        08/11/92

-------
                         DRAFT—DO NOT QUOTE OR CITE

Safe, S.   1990.   Polychlorinated biphenyls  (PCBs), dibenzo-p-dioxins (PCDDs,
dibenzofurans  (PCDFs)  and  related compounds;  environmental and  mechanistic
considerations which  support the development of  toxicity  equivalency factors
(TEFs).  CRC Crit. Rev. Toxicol.  21(1): 51-88.

Safe, S.r  3.  Astroff,  M. Harris et al.   1991.   2,3,7,8-tetrachlorodibenzo-p-
dioxin  (TCDD)  and related  compounds  as antioestrogens:  Characterization and
mechanism of action.  Pharmacol. Toxicol.  69: 400-409.

Schantz, S.L., D.A. Barsotti, J.R. Allen.  1978. Toxicological effects produced
in nonhuman primates  chronically exposed to fifty parts per trillion 2,3,7,8-
tetrachlorodibenzo-p-dioxin (TCDD).  Toxicol. Appl. Pharmacol.  48(1): A180.

Schwetz,  B.A.,  J.M.  Norris,  G.L.  Sparschu et  al.    1973.    Toxicology of
chlorinated dibenzo-p-dioxins.  Environ. Health Perspect.  5: 87-99.

Seefeld,  M.D.  and R.E.  Peterson.  1983.   2,3,7,8-Tetrachlorodibenzo-p-dioxin-
induced weight loss: A proposed mechanism. In: Human and environmental risks of
chlorinated dioxins and related compounds, R.E. Tucker,  A.L. Young and A.P. Gray,
Ed.   Environ.  Sci.  Res.   26: 405-412.

Seefeld,  M.D. and R.E. Peterson. 1984.  Digestible energy and efficiency of feed
utilization in rats treated with 2,3,7,8-tetrachlorodibenzo-p-dioxin. Toxicol.
Appl. Pharmacol.  74:  214-222.

 Seefeld,  M.D., S.W. Corbett,  R.E. Keesey and R.E. Peterson.  1984a.  Character-
 ization of the wasting syndrome in rats treated with 2,3,7,8-tetrachlorodibenzo-
 p-dioxin. Toxicol. Appl. Pharmacol.   73:  311-322.

 Seefeld,  M.D., R.E. Keesey  and R.E. Peterson.  1984b.  Body Weight Regulation in
 rats treated with 2,3,7,8-tetrachlorodibenzo-p-dioxin.  Toxicol. Appl. Pharmacol.
 76:  526-536.
                                      3-57
08/11/92

-------
                          DRAFT—DO NOT QUOTE OR CITE

Shen, E.S., S.I.  Gutman and J.R.  Olson.   1991.   Comparison of 2,3,7,8-tetra-
chlorodibenzo-p-dioxin-mediated hepatotoxicity in C57BL/6J and DBA/2J mice.  J.
Toxicol. Environ. Health.  32: 367-381.

Smith, A.G., J.E. Francis, S.J.E. Kay and J.B. Greig.  1981.  Hepatic toxicity
                                                                   i
and uroporphyrinogen decarboxylase activity following a single dose of 2,3,7,8-
tetrachlorodibenzo-p-dioxin to mice.  Biochem. Pharmacol.   30: 2825-2830.
                                                                   I
Stahl, B.U. and K. Rozman.  1990.  2,3,7,8-Tetrachlorodibenzo-p-dioxin  (TCDD)-
induced appetite suppression in the Sprague-Dawley rat is not a direct effect on
feed intake regulation  in the brain.  Toxicol. Appl. Pharmacol.   106: 158-162.

Stohs, S.J., M.A. Shara,  N.Z. Alsharif, Z.Z. Wahba and Z.A.F. Al-Bayati.   1990.
2,3,7,8-Tetrachlorodibenzo-p-dioxin-induced oxidative stress in  female  rats.
Toxicol. Appl. Pharmacol.  106:  126-135.

Sunahara,  G.I.,  G.W. Lucier,  Z.  McCoy,  E.H.  Bresnick,  E.R. Sanchez and K.G.
Nelson.  1989. characterization of 2,3,7,8-tetrachlorodibenzo-p-dioxin-mediated
decreases  in  dexamethasone  binding  to  rat  hepatic cytosolic  glucocorticoid
receptor.   Mol.  Pharmacol.   36: 239-247.

 Thunberg,  T.  1984.   Effects of TCDD on  vitamin A and  its relation to TCDD-
 toxicity.   In: Banbury  Report 18, A. Poland and R.D.  Kimbrough, Ed. Cold Spring
 Harbor Laboratory,  p.  333-344.                                   :

 Thunberg,  T. and H. Hakansson.   1983.  Vitamin  A (retinol) status in the Gunn
 rat: the  effect  of 2,3,7,8-tetrachlorodibenzo-p-dioxin.   Arch.  Toxicol.  53:
 225-233.

 Thunberg, T., U.G. Ahlborg and H. Johnsson.   1979.  Vitamin A (retinol)  status
 in  the  rat after  a single  oral  dose of  2,3,7,8-tetrachlorodibenzo-p-dioxin.
 Arch.Toxicol.  42:  265-274.
                                       3-58
                                                                        08/11/92

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                          DRAFT—DO NOT QUOTE  OR CITE

Toth, K.,  S. Somfai-Relle, J. Sugar and J. Bence.  1979.  Carcinogenicity testing
of herbicide 2,4,5-trichlorophenoxyethanol containing dioxin and of pure dioxin
in Swiss mice.  Nature.  278: 548-549.

Tuomisto, J. and R. Pohjanvirty.   1987.  The Long-Evans rat: A prototype of an
extremely TCDD-susceptible strain  variant.  Pharmacol. Toxicol.  60(suppl. I):
72.

Turner,  J.N.   and  D.N.  Collins.   1983.   Liver  morphology  in guinea  pigs
administered either pyrolysis products of a polychlorinated biphenyl transformer
fluid or  2,3,7,8-Tetrachlorodibenzo-p-dioxin.   Toxicol.  Appl.  Pharmacol.   67:
417-429.

Umbreit,  T.H.  and  M.A. Gallo.   1988.   Physiological  implications of estrogen
receptor modulation by 2,3,7,8-tetrachlorodibenzo-p-dioxin.  Toxicol. Lett.  42:
5-14.

U.S. EPA.  1984.  Ambient Water Quality Criteria for 2,3,7,8-tetrachlorodibenzo-
p-dioxin.   Office  of Water  Regulations and Standards,  Criteria and Standards
Division, Washington,  DC.  EPA 440/5-84-007.

U.S.  EPA.   1985.    Health  Effects  Assessment for  Polychlorinated dibenzo-
p-dioxins.   Prepared  by the  Office  of Health  and  Environmental Assessment,
Environmental  Criteria and Assessment Office,  Cincinnati, OH for the Office of
Emergency and  Remedial Response, Washington,  DC.  EPA 600/8-84/0146.

U.S. EPA.  1990.' Drinking Water Criteria Document for polychlorinated biphenyls
 (PCBs).    Prepared  by the  Office  of Health and Environmental Assessment,
Environmental  Criteria and Assessment Office,  Cincinnati,  OH for the Office of
Drinking  Water,  Washington,  DC. ECAO-CIN  4-414.
                                      3-59
08/11/92

-------
                         DRAFT—DO NOT QUOTE OR CITE

Van Miller, J.P.,  J.J-  Lalich and J.R.  Allen.  1977.   Increased incidence of
neoplasms in rats exposed to low levels of 2,3,7,8-tetrachlorodibenzo-p-dioxin.

Chemosphere.  61: 625-632.

Vos,  J.G.  and  R.B.  Beems.   1971.   Dermal  toxicity  studies  of  technical
polychlorinated  biphenyls  and fractions  thereof  in rabbit..   Toxicol. Appl.
Pharmacol.  19: 617-633.
                                                                  I
                                                                  I
Vos, J.G. and J.H.  Koeman.  1970.   Comparative toxicologic study with polychlori-
nated biphenyls in chickens with special reference to porphyria, edema  formation,
liver necrosis and tissue  residues.   Toxicol. Appl. Pharmacol.   17:  656-668.


Vos,  J.G., J.A.  Moore  and J.G.  Zinkl.   1973.  Effect  of  2,3,7,8-tetrachloro-
dibenzo-p-dioxin on the immune system of laboratory animals.   Environ.  Health

Perapect. 5:  149-162.
                                                                  I
Vos,  J.G., J.A.  Moore and J.B.  Zinkl.  1974.   Toxicity of 2,3,7,8-tetrachloro-
 dibenzo-p-dioxin  (TCDD)  in  C57  Bl/6 mice.   Toxicol.  Appl.  Pharmacol.   29s

 229-241.

 Wahba,   Z.Z., W.J. Murray,  M.Q.  Hassan  and S.J.  Stohs.   1989a.   Comparative
 effects of pair-feeding and 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on various
 biochemical parameters in female rats.  Toxicology.  59:  311-323.


 Wahba,  Z.Z., T.W. Lawson,  W.J. Murray  and  S.J.  Stohs.    1989b.   Factors
 influencing  the  induction of DNA  single  strand  breaks  in  rats  by  2,3,7,8-
 tetrachlorodibenzo-p-dioxin (TCDD).  Toxicology.   58:  57-69.


 Wahba,  Z.Z., W.J. Murray  and   S.J. Stohs.   1990s.    Desferrioxamine-induced
 alterations  in  hepatic iron distribution,  DNA damage  and  lipid peroxidation in
 control and 2,3,7,8-tetrachlorodibenzo-p-dioxin-treated rats.  J. Appl. Toxicol.
                                                                         CT
 10(2):  119-124.
                                       3-60
                                                                        08/11/92

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                          DRAFT—DO NOT QUOTE OR CITE

Wahba,  Z.Z.,  W.J.  Murray  and  S.J.  Stohs.    1990b.    Altered  hepatic  iron
distribution and release in rats after exposure to 2,3,7,8-tetrachlorodibenzo-p-
dioxin  (TCDD);  Bull. Environ. Contain. Toxicbl;  45: 436-445.

Walden, R. and C.M.  Schiller.   1985.  Short communications.  Comparative toxicity
of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in four (Sub)strains of adult male
rats.   Toxicol. Appl. Pharmacol.   77:  490-495.

Warn,  P., S. Plodstrbm,  L.  Busk,  T.  Kronevi,   I. Nordgren  and U.G. Ahlborg.
1991a.  Relative liver tumor promoting activity  and toxicity of some polychlori-
nated dibenzo-p-dioxin- and dibensofuran-congeners in female SD rats.  Pharmacol.
Toxicol.   (In press)

Warn, F., E. Manzoor, U.G. Ahlborg and H. Hakansson.   1991b.  Effects of 2,3,7,8-
tetrachlorodibenzo-p-dioxin (TCDD) in the lactating rat on maternal and neonatal
vitamin  A  status   and  hepatic  enzyme  induction: A  dose-response  study.
Chemosphere.   23:  1951-1956.

Weber,  L.W.D., M.  Lebofsky,  B.U.  Stahl,  J.R.  Gorski,  G.  Muzi  and K.  Rozman.
 1991.  Reduced activities of key enzymes of gluconeogenesis as possible cause of
 acute  toxicity   of   2,3,7,8-tetrachlorodibenzo-p-dioxin   (TCDD)   in   rats.
 Toxicology.  66: 133-144.

 WHO/IPCS (World Health Organization/International Programme on Chemical Safety).
 1989.  Polychlorinated dibenzo-p-dioxins and dibenzofurans. Environmental Health
 Criteria 88.

 WHO/IPCS (World Health Organization/International Programme on Chemical Safety).
 1991.   Polychlorinated biphenyls  (PCBs).   Polychlorinated  terphenyls (PCTs).
 Environmental Health Criteria.   (in press)
                                       3-61
08/11/92

-------
                          DRAFT—DO NOT QUOTE OR CITE

Wiebel, F.J., U. Klose and F. Kiefer.  1991.  Toxicity of 2,3,7,8-tetrachloro-
dibenzo-p-dioxin in vitro: H4IEC3-derived 5L hepatoma cells as a model system.
Toxicol. Lett.  55: 161-169.


Yang, K.H., W.A. Croft and R.E. Peterson.  1977. Effects of 2,3,7,8-tetrachloro-
dibenzo-p-dioxin  on plasma disappearance  and biliary  excretion  of foreign
compounds in rats.  Toxicol. Appl.  Pharmacol.  40: 485-496.

                                                                  (
Yang,  K.H.,  E.J.  Choi and S.Y. Choe.  1983a.   Cytotoxicity of 2,3,7,8-tetra-
chlorodibenzo-p-dioxin  on primary  cultures  of adult rat  hepatocytes.   Arch.
Environ. Contam. Toxicol.   12:  183-188.


Yang,  K.H.,  B.S. Yoo and  S.Y.  Choe.  1983b.  Effects of  halogenated dibenzo-p-
dioxina  on  plasma disappearance  and biliary excretion of  ouabain  in rats.
Toxicol. Lett.  15: 259-264.


Zacharewski,  T.,   L.  Safe,  S.  Safe  et  al.   1989.   Comparative analysis  of
polychlorinated dibenzo-p-dioxin  and dibenzofuran congeners in Great  Lake  fish
extracts by gas chromatography-mass spectrometry  and  in  vitro enzyme  induction
activities.  Environ.  Sci. Technol.  23:  730-735.


Zinkl, J.G., J.G.  Vos, J.A.  Moore and B.N.  Gupta.   1973.   Hematologic  and
clinical chemistry effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin in laboratory

animals.   ENviron. Health Perspect.  5:  111-118.
                                      3-62
08/11/92

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