f •  ' " '   '•'        United States          Office of Water          EPA 440/5-80-057
                 Environmental Protection     Regulations and Standards    October 1980
                 Agency             Criteria and Standards Division
                                 Washington DC 20460        C • /
&EPA         Ambient
                 Water  Quality
                 Criteria  for
                 Lead

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       AMBIENT  WATER QUALITY CRITERIA FOR

                    LEAD
                 Prepared By
    U.S. ENVIRONMENTAL PROTECTION AGENCY

  Office of Water Regulations and Standards
       Criteria and Standards Division
              Washington, D.C.

    Office of Research and Development
Environmental Criteria and Assessment Office
              Cincinnati, Ohio

        Carcinogen Assessment Group
             Washington, D.C.

    Environmental  Research Laboratories
             Corvalis, Oregon
             Duluth, Minnesota
           Gulf Breeze, Florida
        Narragansett,  Rhode Island
                    Protection Ap»r*r»-

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                              DISCLAIMER
     This  report  has  been  reviewed by the Environmental  Criteria  and
Assessment Office, U.S.  Environmental  Protection  Agency,  and  approved
for publication.   Mention of trade names or commercial products does not
constitute endorsement or recommendation for  use.
                          AVAILABILITY  NOTICE
      This  document is available  to  the public through  the  National
Technical Information Service, (NTIS), Springfield, Virginia  22161.
                                    ii

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                               FOREWORD

    Section 304  (a)(l) of  the  Clean Water Act of  1977  (P.L.  95-217),
requires the Administrator of  the  Environmental  Protection Agency  to
publish criteria  for water  quality accurately reflecting  the  latest
scientific knowledge on the kind and extent of all identifiable effects
on  health  and  welfare  which  may  be  expected from  the presence  of
pollutants in  any body of water, including  ground water.  Proposed water
quality criteria for the 65  toxic  pollutants  listed  under  section 307
(a)(l) of  the  Clean Water Act  were developed and  a notice  of  their
availability was published for public comment on  March 15,  1979 (44 FR
15926), July 25, 1979 (44 FR  43660), and October 1,  1979  (44 FR 56628).
This  document  is a revision of  those  proposed criteria based  upon a
consideration of comments received  from other  Federal Agencies,  State
agencies,  special  interest  groups,  and  individual  scientists.    The
criteria contained in this document replace any previously published EPA
criteria  for  the  65 pollutants.    This  criterion  document  is  also
published in satisifaction of paragraph 11 of the Settlement Agreement
in  Natural  Resources Defense Council,  et.  al.  vs. Train,  8  ERC 2120
(D.D.C. 1976), modified,  12 ERC 1833 (O.D.C.  1979).

    The term  "water  quality  criteria"  is  used in  two sections  of the
Clean Water Act, section 304 (a)(l)  and section 303 (c)(2).  The term has
a different program  impact in  each section.   In  section 304,  the term
represents a  non-regulatory,  scientific assessment of  ecological  ef-
fects. The criteria  presented  in  this  publication  are such  scientific
assessments.   Such  water  quality  criteria  associated  with  specific
stream uses when adopted  as State water quality standards under section
303  become  enforceable  maximum  acceptable  levels  of  a pollutant  in
ambient waters.  The water quality criteria adopted in the State water
quality standards could have the same numerical limits as the  criteria
developed under section 304.  However, in many situations  States may want
to adjust water quality criteria developed under section.304 to reflect
local  environmental conditions  and  human  exposure  patterns  before
incorporation  into  water quality  standards.   It  is not until  their
adoption as part of the State water quality standards that the criteria
become regulatory.

    Guidelines  to  assist the  States  in the modification  of  criteria
presented  in   this  document,  in  the   development of  water  quality
standards, and in other water-related programs of  this Agency,  are being
developed by EPA.
                                    STEVEN SCHATZOW
                                    Deputy Assistant Administrator
                                    Office of Water Regulations and Standards
                                   111

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                                   ACKNOWLEDGEMENTS
Aquatic Life Toxicology:

    Charles E. Stephan, ERL-Duluth
    U.S.  Environmental  Protection Agency

Mammalian Toxicology and  Human Health Effects:

    Paul  B. Hammond (author)
    University of Cincinnati
    Michael L. Dourson (doc. mgr.) ECAO-Cin
    U.S. Environmental Protection Agency

    Jerry F. Stara (doc.  mgr.) ECAO-Cin
    U.S. Environmental Protection Agency

    Patrick Durkin
    Syracuse Research Corporation

    W. Galke, ECAO-RTP
    U.S. Environmental Protection Agency

    Terri Laird, ECAO-Cin
    U.S. Environmental Protection Agency

    K. Mahaffey
    U.S. Food and Drug Administration
John H. Gentile, ERL-Narragansett
U.S. Environmental Protection Agency
Roy E. Albert*
Carcinogen Assessment Group
U.S. Environmental Protection Agency

R.J. Bull, HERL
U.S. Environmental Protection Agency

Thomas Clarkson
University of Rochester

Robert A. Ewing
BatteUe  - Columbus Laboratory

T.J. Haley
National  Center for Toxicological Research

P. Landrigan
Center of Disease Control

H. Needleman
Children's Hospital Medical  Center
Technical Support Services Staff:  D.J. Reisman, M.A. Garlough, B.L. Zwayer,
P.A. Daunt, K.S. Edwards, T.A. Scandura, A.T. Pressley, C.A. Cooper,
M.M. Denessen.

Clerical Staff:  C.A. Haynes, S.J. Faehr, L.A. Wade, D. Jones, B.J. Bordicks,
B.J. Quesnell, T. Highland, 8. Gardiner.
*CAG Participating Members:  Elizabeth L. Anderson, Larry Anderson, Dolph Arnicar,
    Steven Bayard, David L. Bayliss, Chao W. Chen, John R. Fowle III, E5ernard Haberman,
    Charalingayya Hiremath, Chang S. Lao, Robert McGaughy, Jeffrey Rosenblatt, Dharm
    V. Singh, and Todd W. Thorslund.
                                           IV

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                                 TABLE OF CONTENTS
Criteria  Summary

Introduction                                                          A-l

Aquatic Life Toxicology                                               B-l
      Introduction                                                     B-l
      Effects                                                          B-2
          Acute Toxicity                                              B-2
          Chronic Toxicity                                            B-5
          Plant Effects                                               B-8
          Residues                                                    B-9
          Miscellaneous                                               B-9
          Summary                                                     B-ll
      Criteria                                                         B-ll
      References                                                       B-31

Mammalian Toxicology  and  Human  Health  Effects                         C-l
      Introduction                                                     C-l
      Exposure                                                         C-2
          Natural Background Levels                                   C-2
          Man-generated Sources of Lead                               C-3
          Ingestion from  Water                                        C-3
          Ingestion from  Food                                         C-4
          Inhalation                                                  C-9
          Dermal                                                      C-9
          Miscellaneous Sources                                       C-9
      Pharmacokinetics                                                 C-15
          Absorption                                                  C-16
          Dermal                                                      C-19
          Distribution                                                C-19
          Metabolism                                                  C-21
          Excretion                                                   C-21
          Contributions of Lead from Diet versus Air to  PbB           C-22
      Effects                                                          C-35
          Careinogenicity                                             C-48
          Teratogenicity                                              C-63
          Mutagenicity                                                C-66
          Reproductive Effects                                        C-66
          Renal Effects                                               C-68
          Cardiovascular  Effects                                      C-70
          Miscellaneous Effects                                       C-71
      Criterion Formulation                                            C-72
          Existing Guidelines and Standards                           C-72
          Current Levels of Exposure                                  C-72
          Special  Groups  at Risk                                      C-73
          Basis and Derivation of Criterion                           C-73
     References                                                       C-81
Appendix                                                              C-104

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                               CRITERIA DOCUMENT
                                     LEAD
CRITERIA
                                 Aouatic Life
    For  total  recoverable  lead,  the  criterion  (in  ug/1)  to  protect  fresh-
water  aauatic  life as derived  using  the Guidelines,  is the  numerical  value
given  by e(2'35l>(hardness)]-9.48)  as a  24_hour  average  and the  concep_
tration   (in   ug/1)   should  not   exceed   the  numerical   value   given   by
e(1.22[ln(hardness)1-0.47)  at  any time>  For  example> at  hardnesses of  50§

100,  and 200  mg/1  as CaC03  the criteria  are 0.75,  3.8,   and 20  yg/l,  re-
spectively,  as 24-hour averages,  and  the  concentrations  should not  exceed
74, 170, and 400 ug/l» respectively, at any time.
    The  available  data for total  recoverable  lead  indicate  that  acute  and
chronic toxicity to saltwater aauatic  life  occur at  concentrations  as  low as
668 and 25 ug/1, respectively,  and would occur at  lower  concentrations  among
species that are more sensitive than those tested.


                                 Human  Health
    The ambient water  duality  criterion for lead is recommended to be  iden-
tical   to  the  existing  water  standard  which  is  50  wg/1.   Analysis  of  the
toxic   effects  data resulted  in  a  calculated  level which  is protective  of
human   health  against  the  ingestion  of contaminated water  and  contaminated
aauatic organisms.  The calculated  value  is comparable to  the present  stan-
dard.   For this reason  a  selective criterion  based  on exposure solely from
consumption of 6.5 grams  of aauatic organisms was not derived.
                                   VI

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                                 INTRODUCTION

    Lead (atomic weight 207.2) is a soft  gray,  acid-soluble  metal  (Windholz,
1976) and exists  in  three oxidation states, 0, +2, and +4.   Lead  is  a  major
constituent of more  than  200 identified minerals.  Most  of  these are  rare,
and  only three  are found  in  sufficient abundance to form mineral  deposits:
galena  (PbS)  the simple  sulfide,  angelesite (PbS04) the sulfate, and  cer-
rusite  (PbC03)  the  carbonate' (U.S. EPA,  1979).   Lead  is  used in  electro-
plating, metallurgy,  and  the manufacture  of construction materials,  radia-
tion protective devices,  plastics,  and  electronics eauipment.
    Although neither metallic  lead  nor the common lead minerals are  classi-
fied  as  soluble  in  water,  they can both be solubilized by some acids;  in
contrast, some  of the lead  compounds   produced  industrially are  considered
water  soluble.    Natural   lead compounds  are not  usually mobile  in  normal
ground or surface water  because  the lead leached from ores  becomes  adsorbed
by  ferric  hydroxide or  tends  to combine with  carbonate  or  sulfate  ions  to
form  insoluble  compounds  (Hem, 1976).   The  solubility  of lead compounds  in
water depends heavily on  pH  and  ranges from about 10,000,000 yg/1  of lead  at
pH  5.5  to  1  wg/1 at pH  9.0  (Hem  and Durum,  1973).   Lead  does  reach the
aauatic environment  through  precipitation,  fallout of lead dust, street run-
off,  and  both  industrial and  municipal  wastewater  discharges  (U.S.  EPA,
1976).   Inorganic lead  compounds  are   most  stable in the  plus two  valence
state, while  organolead   compounds  are more stable  in  the  plus  four  state
(Standen, 1967).
                                     A-l

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                                  REFERENCES

Hem,  J.D.   1976.   Geochemical  controls  on   lead  concentrations  in stream
water and sediments.  Geochim. Cosmochim. Acta.  40: 599.

Hem,  J.D.  and  W.H.  Durum.  1973.   Solubility  and  occurrence of lead in sur-
face water.  Jour. Am. Water Works.  65: 562.

Standen,  A.  (ed.)  1967.   Kirk-Othmer Encyclopedia of  Chemical  Technology.
Interscience Publishers, New York.

U.S. EPA.  1976.  Quality criteria  for water.   Off.  Water Plan. Stand., U.S.
Environ. Prot.  Agency, Washington, D.C.

U.S.  EPA.   1979.  Water-related  environmental  fate of  129  priority pollut-
ants.  Off. Water Plan. Stand., U.S. Environ.  Prot. Agency, Washington, D.C.

Windholz, M. (ed.)   1976.   The Merck  Index.   9th  ed.    Merck  and  Co.,  Inc.,
Rahway,  New Jersey.
                                     A-2

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Aquatic Life Toxicology*
                                 INTRODUCTION
    The acute  and  chronic adverse effects  of  lead have been studied with  a
variety of freshwater  organisms.   Representative  test animals listed in  Ta-
bles 1  through 6 include fish  from  six different families  (Salmonidae,  Cy-
prinidae,   Catostomidas,  Ictaluridae,  Poeciliidae, and  Centrarchidae),  and
invertebrate species from the nine groups  (rotifers,  annelids,  snails,  clad-
ocerans,  copepods,  isopods,  mayflies,  stoneflies, and  caddisflies).   Tox-
icity tests have also  been  conducted with freshwater plants  from  the algal,
desmid and diatom  groups,  and  both  fish  and invertebrate species have  been
used in bioconcentration tests.
    Acute   toxicity tests  have  been  conducted with  lead and  a  variety  of
saltwater  invertebrates, but no  tests  with fish are  available.  Results  in-
dicate a  range of  acute values  from 668 vg/1  for a  copepod to 27,000  pg/1
for the adult  soft shell  clam.   A chronic  test has  been conducted with  one
invertebrate species,  the  mysid shrimp, and  the  chronic value was 25  yg/1.
Select invertebrate  and  algal  species  are  good accumulators of lead.   Bio-
concentration  factors  calculated on  a  wet weight   basis  ranged from 17.5  for
the hard clam to 2,570 for the  mussel.
    Of the analytical measurements currently available,  a water quality  cri-
terion for lead is probably best  stated in terms   of  total recoverable  lead,
because of the variety of forms  of  lead that  can exist in   bodies of water
and the various  chemical  and toxicological  properties  of these forms.   The
*The reader  is  referred to  the Guidelines  for  Deriving Water Quality  Cri-
teria for the Protection of Aquatic Life and Its Uses in order to better un-
derstand the  following  discussion  and recommendation.  The following  tables
contain the appropriate  data  that  were found in the  literature,  and  at  the
bottom of each  table  are calculations for deriving various measures of  tox-
icity as described in  the Guidelines.
                                     8-1

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 forms  of lead that  are  commonly found in bodies of  water  and are not meas-
 ured by the total recoverable procedure,  such as the  lead  that  is a part of
 minerals,  clays  and sand, probably are forms  that  are less toxic to aquatic
 life and probably will not  be converted to the more toxic forms very readily
 under  natural  conditions.   On the other  hand,  forms of lead that  are common-
 ly found in  bodies  of water  and  are measured by the total recoverable proce-
 dure,  such  as  the free  ion,  and  the hydroxide, carbonate, and sulfate salts,
 probably are forms  that  are  more  toxic to aquatic  life or  can  be converted
 to the  more  toxic forms under natural conditions.
     Because  the criterion is  derived on the  basis of  tests  conducted on sol-
 uble inorganic salts of  lead, the total  and  total recoverable  lead concen-
 trations in  the tests will  probably be about the same, and  a  variety of an-
 alytical procedures  will  produce  about the  same results.   Except  as noted,
 all  concentrations  reported  herein  are expected  to  be essentially equivalent
 to  total  recoverable lead concentrations.   All  concentrations are expressed
 as  lead, not as the compound tested.
                                    EFFECTS
 Acute Toxicity
     Table 1  contains six  acute values  for  three  freshwater  invertebrate spe-
 cies.   Only  one of  the  tests was  flow-through  (Spehar, et  al. 1978) but  in
 two,  the  toxicant  concentrations  were   measured   (Spehar,  et   al.  1978;
 Chapman, et  al. Manuscript).   Acute tests  were conducted at three different
 levels  of  water  hardness with  Daphnia magna  (Chapman,  et   al. Manuscript),
 demonstrating that daphnids were  three times more  sensitive to lead  in  soft
water than in  hard  water.   This  acute value for Daphnia magna in  soft  water
 agrees closely with the value  reported earlier for  the same species  in  soft
water by Biesinger'  and Christensen (1972).   Rotifers  tested for 96  hours  in
                                     B-2

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soft water  by Buikema,  et  al.  (1974)  were very resistant to  lead;  however,
scuds were  reported  by Spehar, et  al.  (1978) to  be  more sensitive to  lead
than any other invertebrate thus far tested.   Interestingly,  this  same  rela-
tionship existed in longer exposures lasting up to 28 days in  which  the  scud
was far more  sensitive to  lead  than  a  snail,  cladoceran,  chironomid, mayfly,
stonefly, and caddisfly (Table 6) (Spehar, et  al.  1978;  Biesinger  and  Chris-
tensen, 1972; Anderson,  et al. 1980;  and Nehring,  1976).
    Thirteen  acute toxicity tests have  been  conducted on lead with  six  spe-
cies  of  fish  (Table  1).   Of the   13   only  three  were  reported  to  be
flow-through,  and  measured toxicant  concentrations  were  reported  for  only
one  (Holcombe, et  al.  1976).  The  results  of  acute   tests  conducted  by
Oavies,  et  al.  (1976)  with  rainbow trout  in hard  water  are  reported  as
unmeasured  values  in Table  1, because  total  lead  concentrations  were  not
measured, even though the dissolved  lead concentrations  were.
    The data  in  Table 1  indicate a  relationship between water  hardness  and
the acute toxicity of lead to rainbow trout  (Davies,  et al.  1976), fathead
minnows and bluegills (Pickering and Henderson, 1966), because lead  was  gen-
erally much more toxic  in soft water.    Another  example of  the  effect  of
hardness was  reported by Tarzwell and Henderson  (1960) who conducted 96-hour
exposures of fathead  minnows to lead in soft and hard water  (20  and  400  mg/1
as  CaCO,,   respectively).   Results  from  the  soft water  test are  shown  in
Table 1.   The hard water  exposure  is  included  in Table  6  because an  LC^Q
value was not obtained within  96 hours; however, this test did show  that  the
hard water  LC5Q value  was greater  than   75,000  yg/1  which  meant  that  the
LCcQ in  hard  water  was  at  least 31  times that  in  soft water.  Hale  (1977)
conducted an  acute  exposure  of  rainbow  trout to  lead  and  obtained an  IC™
value of  8,000 yg/1.   This value is  six   times greater  than  the  LC50 value
                                     B-3

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 obtained for rainbow trout in soft water by Davies, et  al.  (1976).   Hale  did
 not report water  hardness;  however,  alkalinity  and  pH were  reported  to  be
 105 mg/1 and 7.3, respectively, which  suggests  that  this water was  probably
 harder than the soft test water  used  by Davies, et al.  (1976).   Wallen,  et
 al. (1957) also reported  high  acute  lead  values  for  the mosquitofish; how-
 ever,  these authors  also did  not  report water  hardness and the test was con-
 ducted in turbid water contining  suspended clay particles at apporoximately
 300,000 wg/1  (Table  6).  Pickering and  Henderson (1966) found that lead ace-
 tate was about  as  toxic  as lead chloride to the fathead minnow in soft water
 (Tables  1  and 6).
    An exponential  equation  was  used  to describe  the observed  relationship
 of  the acute toxicity of  lead  to  hardness  in  fresh water.   A  least  squares
 regression  of  the  natural  logarithms  of  the  acute  values  on the  natural
 logarithms  of hardness  produced slopes  of  1.05,  2,48,  1.60, and  1.01,  re-
 spectively,  for Daphnia  magna, rainbow trout,  fathead minnow,  and  bluegill
 (Table  1).  The slope for  Daphnia  magna was significant,  but  that  for  rain-
 bow  trout was  not.   The  slopes  for  the  bluegill and  fathead  minnow  were
 based  on data  for  two  hardnesses  each,  although  four  tests are  available
 with the minnow.  An arithmetic  mean  slope of  1.22  was  calculated  for  the
 three  species other  than the rainbow  trout.  This  mean slope was used  with
 the geometric mean  toxicity  value  and  hardness for each  species to obtain a
 logarithmic  intercept  for  each of  the nine  freshwater  species  for  which
 acute values are available  for lead.
    The  species  mean  intercept, calculated as the  exponential  of the  loga-
 rithmic  intercept,  was  used  to  compare  the  relative  acute  sensitivities
 (Table  3).   The Guidelines specify that in order to  derive a criterion  the
minimum data base should include at least one  acute value for a benthic  in-
 sect.    No  such   value  is   available for lead.    However,   7-  to  28-day  soft
                                     B-4

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water exposures of the mayfly,  stonefly,  and  caddisfly to lead have been re-
ported by Nehring (1976), Warnick and Bell  (1969),  and Spehar,  et  al.  (1978)
(Table 6).  Their results  indicate  that benthic insects  are  rather insensi-
tive to  lead.  Although  the data are  not  really comparable,  it  appears  that
the  caddisfly  may be the  least sensitive of the  three and may be slightly
less sensitive than the  goldfish.   In an  attempt to account  in  some way for
these insensitive species  in  the derivation of  the  Final  Acute Intercept,  a
caddisfly was  entered  as the  least sensitive species  in  the  list  of  fresh-
water intercepts in  Table 3.
    A freshwater  Final  Acute  Intercept of  0.623 yg/1   was  obtained for  lead
using the species mean intercepts listed  in Table  3  and the calculation  pro-
cedures  described in  the  Guidelines.    Thus  the  Final   Acute  Equation  is
e(1.22[ln(hardness)]-0.47)< '
    No standard acute toxicity  values for saltwater  fish  species  are availa-
ble but  several  are  available for invertebrate  species.   The  most  sensitive
invertebrate species was a copepod Acartia  clausi  with an LC™ of 668  yg/1
and  the  least  sensitive was  the soft shell  clam  Mya  arenaria with an  LC™
of  27,000.   A  value of  2,450  was  obtained  with  oyster  larvae  Crassostrea
virginica  in   a  static  test  and  a LC5g  of 2,960  was  recorded   for mysid
shrimp Mysidopsis bahia  in  a  flow-through test  in which  concentrations  were
measured  (Table  1).   Acute values  are  not  available  for  enough  appropriate
kinds of species to  allow calculation  of a Saltwater Final Acute Value.
Chronic Toxicity
    Four  tests  of the chronic  toxicity of  lead to freshwater  invertebrate
species have been conducted (Table 2).  Chapman, et  al. (Manuscript) studied
the chronic  toxicity  of lead  to Daphnia magna  at three  different hardnes-
ses.  Results  shown  in  Table  2  demonstrate  that  daphnids  were   nearly  11
                                     B-5

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times  more  sensitive to lead  in  the  soft  water.   For the  same  species  in a
different soft  water,  a chronic value over  four  times higher  (Table  6) was
obtained by  Biesinger  and  Christensen (1972) in  a  test  in  which the concen-
trations of  lead were  not  measured.   Use  of the  comparable acute  value  of
450 ug/1 (Table 1) results in an acute-chronic ratio of 8.2.
    A  life  cycle test  on  lead  in hard water was conducted by  Borgmann,  et
al.  (1978)  with snails.   These authors used biomass as their  endpoint and
reported that  lead  concentrations  as  low as 19 ug/1  significantly decreased
survival but  not growth or  reproduction.    After  a thorough review  of  this
work,  however,  it  was  not  at  all  clear how these investigators  arrived  at
such  a low  effect  concentration.   This publication  did,   however,  contain
suitable information  for  determining  a chronic value.  Chronic  limits  were
taken  directly  from the cumulative percent  survival  figure which  showed  no
observed effect  on  survival  at 12 ug/1 and  almost complete mortality at  54
ug/1.   The  chronic value  for  snails  shown  in  Table  2 was  therefore  estab-
lished  at 25  ug/1,  which  is somewhat  lower  than  the  chronic value reported
for daphnids in hard water.
    Seven chronic  tests  on lead  have been  conducted with  six  species  of
freshwater fish  (Table  2), all of  which  were  in  soft water.   In addition,
Davies, et  al.  (1976)  described the  long-term  effects on  rainbow trout fry
and finger!ings  exposed to  various  concentrations of  lead  for   19  months  in
hard and soft water  (Table 6).  Although these  experiments  were  neither  life
cycle  (no natural  reproduction) nor  early  life stage (no  embryos exposed),
they  do provide  valuable  information  concerning  the relationship  between
water hardness and chronic lead toxicity to  fish.   During these  19-month ex-
posures, most of the  trout (60 to 100 percent) developed spinal deformities
in  hard water   at  measured  lead  concentrations of  850  ug/1   and  above.
                                     B-6

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 However,  during  the  soft  water  exposure  most  trout   (44  to  97  percent)
 developed  spinal  deformities  in measured  lead  concentrations  as low  as 31
 ug/1   (Table  6).    These  results  strongly  demonstrate  that  lead  is  more
 chronically  toxic in  soft  water  than  in  hard water.
     Davies,  et  al.  (1976)  also published results of an early life stage test
 with  rainbow trout  in  soft  water  (Table  2).  Even  through this  test was
 started  with embryos  and  continued  for 19 months  after  hatch,  it could not
 be  considered  a  life cycle  test  because  no  reproduction occurred.   The
 chronic  limits  that  these  authors  chose were somewhat lower than those shown
 in  Table 2,  because  they based  their  results  on a  very low  incidence of
 black  colored tails  and  spinal  deformities  (0.7 and 4.7 percent, respective-
 ly).   Because  this  test was not conducted  with  duplicate exposures, statis-
 tically  significant  differences could not be  determined.   After careful ex-
 amination of  their results it  was  decided that  the chronic  limits  (Table 2)
 should  be  established  on  the  occurrence  of  spinal  curvatures only and  at
 lead  concentrations  which caused  a  substantial  increase in these  deformi-
 ties.  Even  though the incidence of  black  tail was apparently related  to the
 concentration of  lead,  it could not  by itself be  considered   an  important
 adverse effect.
    Spinal  deformities have also  been  cause  by lead in  a  life cycle  test
 with brook trout  (Holcombe,  et  al. 1976) and in early life  stage  tests  with
 rainbow  trout,  northern  pike  and  walleye  (Sauter,  et  al.  1976).   On  the
 other  hand,  Sauter,  et al.  (1976) did  not  observe deformities  during  early
 life stage  tests  with lake  trout, channel  catfish, white sucker, and  blue-
 gill.  Results  of tests  by Sauter,  et al.  (1976) with  northern  pike  and
walleye,  however,  were not included   in  Tables 2 and  6 because  of excessive
mortality due  to  cannibalism  and  feeding  problems.   The chronic value  ob-
tained for  rainbow  trout  by  Sauter,  et al.  (1976)  is somewhat higher  than
                                     B-7

-------
 that  chronic  value  derived  from Oavies,  et  al.  (1976).   Even  though  the
 hardnesses  were  about  the same,  differences could  be due  to  differences in
 the length  of  exposure (2 months vs. 19 months).
    As  was  done  with  the  freshwater  acute values,  the freshwater  chronic
 values  of  Chapman, et  al.  (Manuscript)  were  regressed against  hardness to
 account for the  apparent  effect  of hardness on the chronic  toxicity  of lead
 and a  slope of 2.35 was  obtained.   Even  though this slope is not significant
 because it  is  based  on only  three values,  it  relects the obvious  effect of
 hardness  on chronic toxicity.   In  the  same  manner as  for acute toxicity,  the
 chronic slope  was used with  the geometric mean  chronic toxicity  value  and
 hardness  for  each species  to obtain  a  logarithmic intercept and  a  species
 mean chronic intercept for each  species for which a chronic  value is  availa-
 ble  (Table  2).  A Freshwater Final  Chronic  Intercept  of 0.000076 wg/l  was
 then obtained  using the  calculation  procedures described in the  Guidelines.
 Thus, the Final Chronic Equation is e(2'35f1n(hardness)]-9.48)>
    The mysid  shrimp  Mysidopsis  bahia is  the only  saltwater species with
which  a chronic  test  has been conducted  on  lead  (Table 2).   The  most  sens-
 itive observed adverse effect was  reduced spawning  (U.S. EPA, 1980)  and  the
 resulting chronic  value  was  25  ug/1.   The 96-hour |_C50 for this  same spe-
cies in the same  study was  2,960  wg/1, producing an  acute-chronic ratio  of
 119.
 Plant Effects
    Four  static tests on  three  species of algae  have been reported by  Mona-
han (1976)  (Table 4).   These exposures  were conducted for 7  days  and  concen-
trations of lead were not measured.  Results of short exposures  of algae  and
diatoms to unmeasured  lead concentrations have also been published  by Malan-
chuk and  Gruendling   (1973)   (Table  6).   The  adverse  effect  concentrations
from these tests ranged from  500  to  28,000  ug/l.   It  would  appear  therefore
                                     B-8

-------
that  any  adverse effects  of  lead on  plants are unlikely  at  concentrations
protective of chronic effects on freshwater animals.
    No saltwater  plant  species  have  been exposed to  inorganic  lead,  but one
saltwater  algal   species  Dunaliella  tertiolecta  has  been   exposed  to  both
tetramethyl  and   tetraethyl  lead.   The  results  (Table  6)   demonstrate  that
this  species  is  more sensitive  to tetraethyl  lead  by a factor  greater  than
10.   No  data are available concerning  the relative  toxicities  of  inorganic
lead and these organolead compounds.
Residues
    Four  freshwater  invertebrate  species  have been  exposed to  lead  (Borg-
mann, et  al. 1978;  Spehar,  et   al.  1978) and  the bioconcentration  factors
ranged from 499  to 1,700  (Table  5).  Brook trout  and  bluegills  were also ex-
posed to  lead (Holcombe,  et al.  1976,  and Atchison, et al.  1977) and  calcu-
lated bioconcentration factors were 42  and 45, respectively  (Table 5).
    Some  species of  saltwater  bivalve  molluscs,  diatoms   and  phytoplankton
are  capable  of  accumulating  lead (Table  5).  The bioconcentration  factors
range from  17.5  with the  hard  clam  to  2,570  with  the mussel.   Because  the
duration of  the  study may be an important consideration  in bioconcentration
studies, this comparison  is not  entirely valid since the mussel  was  exposed
for 130 days and the hard clam for only 56 days.
    Neither a freshwater  nor' a  saltwater Final  Residue  Value  can  be  calcu-
lated because no maximum  permissible  tissue concentration   is   available  for
lead.
Miscellaneous
    Many  of  the  values  in  Table  6  have  already been  discussed.   Spehar
(1978) found no  adverse  effects  on a  freshwater  snail,  scud,   stonefly,  and
caddisfly in 28 days at 565 yg/1.  Pickering  and  Henderson  (1966) found  that
lead chloride and lead acetate are about equally toxic to fathead minnows  in
                                     8-9

-------
 static tests  in  soft  water (Table 1 and 6), but Wallen, et  al.  (1957)  found
 that lead oxide  is much  less  acutely  toxic  than lead nitrate to  the  mosqui -
 tofish in turbid water.
     The  10-day  test  conducted by  Anderson,  et al.  (1980)  (Table 6)  showed
 that the midge,  Tanytarsus dissimilis,  is  rather  insensitive to  lead with  a
 chronic  value of  258 yg/1.   This test  included  exposure  of  the  species
 during most  of its life cycle and several  of the presumably sensitive molts,
 and so should probably be  considered  as useful as  the early life stage  test
 with fish.
     A variety of other effects  on  saltwater organisms  have  been observed.
 Gray and Ventilla  (1973)  observed  a reduction  in  growth rate  in a ciliate
 protozoan after  a  12  hour  exposure to  a  lead  concentration  of  150 yg/1.
 Woolery and  Lewin (1976)  observed a reduction in photosynthesis and respira-
 tion in  the  diatom  Pheodactylum  tricornutum at   concentrations  of   lead
 ranging  from  100 to  10,000   yg/1.   However,  Hannan  and Patouillet  (1972)
 obtained  no   growth  inhibition with  £. tricornutum at  a  concentration of
 1,000  yg/1  after  72  hours.   Rivkin  (1979)  using growth rate  to determine
 toxicity  to   the  diatom,   Skeletonema  costatum, reported a   12  day EC50 of
 5.1  yg/1.  Messier  (1974) observed delayed cell division in  the phytoplank-
 ton,  Platymonas  subcordiformus,  after  treatment  with  2,500   yg/1  for  72
 hours.  At 60,000 yg/1,  Messier (1974) reported not  only growth retardation
 but  also  death.   Benijts-Claus  and Benijts  (1975)  observed  delayed  larval
 development in the  mud  crab,  Rhithropanopeus  harrisii, after treatment  with
 lead  concentrations  of 50  yg/1.    In  Fundulus  heteroclitus,  Weis and  Weis
 (1977)  observed  depressed  axis  formation  in  developing embryos  with  lead
 concentrations of 100  yg/1.   Reish  and Carr (1978),  found  that  1,000  yg/1
 suppressed reproduction of two polychaete species, Ctenodriluis  serratus  and
Ophryotrocha  disdema,  in a 21-day  test.
                                     B-10

-------
Summary
    Standard acute data for  lead  are available for nine  freshwater  fish and
invertebrate species with  a  range from 124  to 542,000 yg/l.   Chronic  tests
have been conducted with  two invertebrate species and  six  fish species with
the chronic values ranging from 12  to  174 wg/l.  Both  the  acute  and chronic
toxicities of lead to freshwater animals decrease as  hardness increases.
    Freshwater algae are  affected by concentrations  of lead  above  500  yg/1,
based on  data  for three  species.   Bioconcentration  factors  ranging  from 42
to 1,700 are available for four invertebrate and two  fish  species.
    Acute values for five  saltwater  species  ranged from 668 yg/1  for a  cope-
pod to  27,000  yg/1 for  the  soft  shell  clam.  A  chronic toxicity  test was
conducted for the  mysid  shrimp and adverse  effects were  observed at 37 yg/l
but not at 17 yg/1.  The acute-chronic ratio for this species is 118.
    Delayed embryonic development,  suppressed reproduction  and  inhibition of
growth rate among fish, crab,  polychaete  worm,  and plankton were  also caused
by lead.
                                   CRITERIA
    For total recoverable  lead  the  criterion (in  yg/1)  to protect freshwater
aquatic life as derived using  the Guidelines is the  numerical value given by
e(2.35[ln(hardness)]-9.48) as  a  24-hour  average and  the  concentration (in
yg/1)  should  not  exceed  the  numerical  value  given  by e^1-22[ln(hardness)]
-°-47) at any time.  For example,  at hardnesses of 50, 100,  and  200 mg/1 as
CaC03  the criteria  are  0.75,  3.8,  and  20  yg/l,  respectively,  as  24-hour
averages, and  the concentrations  should  not exceed   74,  170,  and  400  yg/l,
respectively, at any time.
                                     B-ll

-------
    The available  data for  total  recoverable  lead  indicate that  acute  and
chronic toxicity to saltwater aquatic  life occur  at  concentrations  as low as
668 and 25 yg/1, respectively,  and would  occur  at lower concentrations among
species that are more sensitive than  those tested.
                                    B-12

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                                             Table  1.  Acute values for  lead
Species
Method*
                                           Chemical
Hardness                   Species Mean
(mg/l as     LC50/EC50»»   Acute Value"
CaOM       (ug/l)           (ug/|
                                                                                                        Reference
FRESHWATER SPECIES
Rotifer,
Ph Medina acutlcornls
Cladoceran,
Daphnla magna
Cladoceran,
Daphnla magna
Cladoceran,
Daphnla maqna
C 1 adoceran,
Daphnla magna
Scud,
B Gammarus pseudol Imnaeus
{-* Rainbow trout.
Sal mo qalrdnerl
Rainbow trout.
Sal mo gairdneri
Rainbow trout.
Sal mo galrdnerl
Rainbow trout (2 mos).
Sal mo gairdneri
Brook trout (18 MOS),
Salvelinus fontlnalis
Fathead minnow,
Plmephales promelas
Fathead minnow,
Plmephales promelas
Fathead minnow,
Pimephales promelas
S, U
S, U
R, M
R, M
R, M
FT, M
S, U
S, U
FT, U
FT, U
FT, M
s, u
S, U
s, u
Lead chloride
Lead chloride
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead chloride
Lead chloride
Lead chloride
25
45
54
110
152
46
290
353
28
-
44
20
20
20
40,800
450
612
952
1,910
124
542,000
47 1 ,000
1,170
8,000
4,100
2.400
5,580
7,330
Bulkema, et al. 1974
Bieslnger &
Christen sen, 1972
- Chapman, et al.
Manuscript
Chapman, et al.
Manuscript
Chapman, et al.
Manuscript
Spehar, et al. 1978
Davles, et al. 1976
Davles, et al. 1976
Davles, et al. 1976
Hale, 1977
Holcombe, et al. 1976
Tarzwel 1 & Henderson,
I960
Pickering &
Henderson, 1966
Pickering &
Henderson, 1966

-------
Table 1.  (Continued)
Species Method*
Fathead minnow, S, U
Plmephales promelas
Goldfish, S, U
Carasslus auratus
Guppy (6 mos), S, U
Poeci 1 la reticulata
Bluegil 1, S, U
Lepomis macrochirus
Bluegi II, S, U
Lepomis macrochirus
Oyster, S, U
td Crassostrea vlrginlca
*» Hard clam, S, U
Mercenarla mercenaria
Soft shell clam (adult), S, U
Mya arenarla
Mysid shrimp, FT, M
Mysidopsls bahia
Copepod, S, U
Acartla clausl

Hardness Species Mean
(rng/l as LC50/EC50** Acute Value**
Chemical CaC03> (ug/l) (ug/1 Reference
Lead chloride 360 482,000
Lead chloride 20 31,500
Lead chloride 20 20,600
Lead chloride 20 23,800
Lead chloride 360 442,000
SALTWATER SPECIES
Lead nitrate - 2,450 2,450
Lead nitrate - 780 780
Lead nitrate - 27,000 27,000
Lead nitrate - 2,960 2,960
Lead nitrate - 668 668
Pickering &
Henderson, 1966
Pickering &
Henderson, 1966
Pickering 4
Henderson, 1966
Pickering &
Henderson, 1966
Pickering &
Henderson, 1966
Calabrese, et al.
1973
Calabrese & Nelson,
1974
Elsler, 1977
U.S. EPA, 1980
U.S. EPA, 1980
 * S = static,  R = renewal, FT = flow-through, M = measured, U = unmeasured



 **Results are expressed as lead, not as the compound.

-------
               TabU  I.   (Continued)
I
M
Ln
               Freshwater
                              Acute toxlclty vs. hardness
                    Daphnla maqna:  slope = 1.05. Intercept * 2,13, r * 0.97, p = 0.05, n = 4
                    Rainbow trout:  slope - 2.48, Intercept = -1.16, r = 0.99, not significant, n = 3
                    Fathead minnow:  slope = 1.60, Intercept » 3.62, r = 0.98, p = 0.05, n = 4
                    BJueglll:  slope = 1.01, Intercept = 7.05, r = 1.00, n = 2
                         Arithmetic mean acute slope = 1.22 (slope for rainbow trout not used)

-------
                                                            Table 2.  Chronic values for lead
w
 I
               Species
Test*
Chemical
Hardness
(mg/l as       Limits
CaCOr)         tug/I)
Chronic Value**
   (ug/l)        Reference
FRESHWATER SPECIES
C ladoceran,
Daphnla magna
Cladoceran,
Daphnla magna
Cladoceran,
Daphnia magna
Snai 1,
Lynrnea palustris
Rainbow trout,
Sal mo galrdnerl
Rainbow trout,
Sal mo gairdneri
Brook trout,
Salvellnus fontinalis
Lake trout,
Salvelinus namaycush
Channel catfish,
Ictalurus punctatus
White sucker,
Catostomus commersoni
Bluegill,
Lepomis macrochlrus
Mysld shrimp,
Mysidopsls bahia

LC
LC
LC
LC
ELS
ELS
LC
ELS
ELS
ELS
ELS
LC
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate
SALTWATER
Lead nitrate
52
102
151
139
28
35
44
33
36
38
41
SPECIES
—
9-17
78-18)
85-193
12-54
13-27
71-146
58-119
48-83
75-136
1 19-253
70-120
17-37
12
119
128
25
19
102
83
63
101
174
92
25
Chapman, et al.
Manuscript
Chapman, et al.
Manuscript
Chapman, et al.
Manuscript
Bor groan n, et al
Davles, et al.
Sauter, et al.
Holcombe, et al
Sauter, et al.
Sauter, et al.
Sauter, et al.
Sauter, et al.
U.S. EPA, 1980
. 1978
1976
1976
. 1976
1976
1976
1976
1976
               * LC  =  life  cycle  or  partial  life cycle, ELS = early  life stage

               •"Results  are  expressed  as  lead, not as the compound.

-------
               Table 2.   (Continued.
               Freshwater

                              Chronic toxiclty vs.  hardness

                    Dafihnla mag,*:   slope = 2.35,  intercept = -6.60.  r = 0.94, not significant, n = 3

                         Chronic slope = 2.35 (see  text)
to
 Species

 Cladoceran,
 Daphnia maqna

 Cladoceran,
 Daphnia maqna

 Cladoceran,
 Daphnia magna

 Rainbow trout,
 Salmo gairdneri

 Brook trout,
 Salvellnus  fontinalis

 BluegiI I,
 Leponuls  macrochlrus

 Mysld shrimp,
jfysidopsls
                                                                   Acute-Chronic  Ratios

                                                                        Acute  Value      Chronic  Value
                                                                            (ug/D            (ug/l)
                                                                             612
                                                                             952
                                                                           1,910
                                                                           1,170
                                                                           4,100
                                                                          23,800
                                                                           2,960
                                                                                               12
                                                                                              119
                                                                                             128
                                                                                              19
                                                                                              83
                                                                                              92
                                                                                              25
Ratio

  51


   8


  15


  62


  49


259


118

-------
Table 2.  (Continued)
                                                                            Species Mean
                                                                          Chronic Intercept
Rank*
8

7

6

5

4

W 3
i
00
2

1

Spec 1 es
White sucker.
Catostomus commersonl
Channel catfish.
1 eta 1 urus punctatus
Lake trout,
Sa 1 ve 1 1 nus namaycush
Bluegill,
Lepomis macrochlrus
Rainbow trout.
Sal mo galrdnerl
Brook trout.
Salvelinus fontlnalis

Cladoceran,
Daphnla magna
Snail,
Lymnea palustrls

-------
                                            Table 3.  Species mean acute  Intercepts  and  values  and  acute-chronic ratios for lead
ra

t->
ID


lank*

10

9

8

7

6

5

4

3

2

1


Species

Caddisf ly,»*
(unspecified)
Goldfish,
Carasslus auratus
Rotifer,
Ph 1 1 od 1 na acut 1 corn 1 s
Guppy,
Poeci 1 la retlculata
Bluegil 1,
Lepomls macrochlrus
Fathead minnow.
Plmephales promelas
Rainbow trout,
Sal mo gairdnerl
Brook trout.
Salvelinus font! nails
Cladoceran,
Daphnla magna
Scud,
Species Mean
Acute Intercept
(yg/l)
FRESHWATER SPECIES
—

815

804

533

455

158

158

40.5

4.02

1.16
Species Mean
Acute-Chronic
Ratio

_

—

.



259

_

62

49

18

_
                                                           Gammarus pseudolImnaeus

-------
                                          Table 3.   (Continued)

                                                                                  Species Mean     Species Mean
                                                                                  Acute Value      Acute-Chronic
                                          Rank*      Species                          (U9/D            Ratio
w
to
o
5
4
3
2
1
SALTWATER
Soft she! 1 clam,
Mya arenaria
Mysld shrimp,
Mysidopsls bahia
Oyster,
Crassostrea vlrglnlca
Hard clam,
Mercenarla mercenarla
Copepod,
Acart i a c 1 aus 1 1

SPECIES
27,000
2,960
2,450
780
668
118
                                          *  Ranked from least sensitive to most sensitive based on species mean
                                             acute Intercept or value.

                                          »» See text.

                                          Freshwater
                                               Final Acute Intercept = 0.623 ug/l

                                                    Natural  logarithm of 0.623 = -0.47

                                                    Acute slope = 1.22 (see Table 1)

                                               Final Acute Equation = e<1.221In(hardness)1-0.47)

-------
                                          Table 4.  Plant values for  lead
Species
Alga,
Anki strodesmus sp.
Alga,
Chi ore! la sp.
Alga,
Scenedesmus sp.
Alga,
Selenastrum sp.
to
Hardness
(mg/l as Result*
Chemical CaCO,) Effect 
-------
                                                              Table  5.  Residues  for lead
                                                                                   BIoconcentrat Ion
Duration
 (days)      Reference
K)
to
Spec 1 es
Snal 1,
Lymnea jaalustrls
Snail,
Physa Integra
Stonef ly,
Pteronarcys dorsata
Caddisf ly.
Brachycentrus sp.
Brook trout (embryo- 3 mos),
Salvel inus fontinalis

Bluegl 1 1,
Lepotnls macrochlrus

Oyster,
Crassostrea vlrglnlca
Oyster,
Crassostrea vlrglnlca
Oyster,
Crassostrea vlrglnlca
Ouahaug, hard clam,
Mercenaria mercenaria
Soft shel 1 clam.
Mya arenarla
Mussel,
Mytllus edul Is
Mussel,
Mytl lus edul is
T 1 ssue
Whole body
Whole body

Whole body
Whole body
Whole body


Whole body


Soft parts
Soft parts
Soft parts
Soft parts

Soft parts
Soft parts
Soft parts

onemitai
FRESHWATER SPECIES
Lead nitrate
Lead nitrate

Lead nitrate
Lead nitrate
Lead nitrate


"

SALTWATER SPECIES
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate

Lead nitrate
Lead nitrate
Lead chloride


1,700*
738*

1,120*
499*
42*

AS*
*v J


536
68*
1,400
17.5*

112*
650*
200*


120 Borgmann, et al. 1978
28 Spehar, et al. 1978

28 Spehar, et al. 1978
28 Spehar, et al. 1978
140 Holcombe, et al. 1976

-** Atchison, et al. 1977



140 Zaroogian, et al.
1979
49 Pringle, et al. 1968
70 Shuster i Pringle,
1969
56 Pringle, et al. 1968

70 Pringle, et al. 1968
40 Schulz-Baldes, 1974
37 Talbot, et al. 1976


-------
Table 5.  (Continued)
Species
TIssue
                 Chemical
BIoconcentratIon     Duration
     Factor           (days)
                                                                                                   Reference
Musse 1 ,
Myti lus edul is
Mussel,
Myti lus edul is
Mussel ,
Myti lus edul is
Diatom,
Phaeodacty turn tricornutum
Diatom,
Ditylum brightwel 1 i I
Phytoplankton,
Platymonas subcordiformis

, * B ioconcentrat ion factors
M
Soft parts
Soft parts
Soft parts
Whole body
Cells
Whole body
have been converted
Lead n i trate
Lead nitrate
Lead nitrate
Lead chloride
Lead chloride
Lead chloride
from dry weight
2,570*
2,080*
796*
1,050*
725*
933*
to wet weight.
130 Schu Iz-Baldes,
130 Schu Iz-Baldes,
130 Schu Iz-Baldes,
1/24 Schu Iz-Baldes,
14 Canterford, et
1978
1/24 Schu Iz-Baldes,

1972
1972
1972
1976
at,
1976

  analyzed for lead,  zinc and  cadmium.

-------
Species
  Chemical
Table 6.  Other data for  lead

Hardness
(ing/1 as
 CaCOx)      Duration
                                                        FRESHWATER SPECIES
                                                                                 Effect
                 Result*
                 (pg/I)     Reference
Alga,
Anabaena sp.
                               Lead nitrate
                                 24 hrs
                              50% reduction
                              of  14C02
                              fixat ion
                  15,000     Malanchuk & Gruendling,
                            1973
Alga,
Anabaena sp.
                               Lead nitrate
                                 24 hrs
                              50? reduction
                              of  14C02
                              fixation
                 26,000     Malanchuk & Gruendling,
                            1973
Alga,
Anabaena sp.
                               Lead nitrate
                                 24 hrs
                              50? reduction
                              of  14C02
                              fIxatIon
                  15,000     Malanchuk i Gruend I Ing,
                            1973
Alga,
Chtamydomonas sp.
                               Lead nitrate
                                 24 hrs
                              50? Deduction
                              of  14C02
                              fixation
                 17,000     Malanchuk & Gruendling,
                            1973
Alga,
Chlamydomonas sp.
Lead nitrate
              24 hrs
50? reduction
of 14C02
f Ixat Ion
17,000     Malanchuk i Gruend I ing,
           1973
Desmid,
Cosmarlum sp.
                               Lead nitrate
                                 24 hrs
                              50? reduction
                              of  14C02
                              fixation
                  5,000     Malanchuk & Gruend I Ing,
                            1973
Desmid,
Cosmarlum sp.
Lead nitrate
              24 hrs
50? reduction
of 14C02
fIxat ion
 5,000     Malanchuk & Gruend I ing,
           1973
Desmid,
Cosmarlum sp.
Lead nitrate
              24 hrs
50? reduction
of 14C02
fixation
 5,000     Malanchuk i Gruend I Ing,
           1973
D i atom,
Navlcula sp.
Lead nitrate
              24 hrs
50? reduction
of 14C02
fixation
17,000     Malanchuk & Gruend I ing,
           1973
Diatom,
Navicula sp.
Lead nItrate
              24 hrs
50? reduct ion
of 14C02
fixation
28,000     Malanchuk i Gruendl ing,
           1973

-------
Table 6.  (Continued)

Species
Diatom,
Nay leu la sp.

Sludge worm,
Tublfex sp.
Sludge worm,
Tublfex so.
Snail,
Gonlobasls^ llvescens
Snail,
Lymnaea emarg 1 nata
Snail,
Physa Integra

Cladoceran,
Daphn la magna

Cladoceran,
Daphn la magna
Scud,
Gammarus pseudol Imnaeus
Chironomid
(embryo - 3rd instar),
Tany tarsus disslml Us
Mayfly,
Ephemerel la^ grand Is
May-fly (nymph),
Ephemere 1 1 a_ grand 1 s

Mayfly,
Ephemerel la subvaria

Chemical
Lead nitrate

Lead nitrate
Lead nitrate
Lead acetate
Lead acetate
Lead nitrate

Lead chloride

Lead chloride
Lead nitrate
Lead nitrate
Lead nitrate
Lead nitrate

Lead su 1 fate
Hardness
(«g/l as
CaCOO
-

-
-
154
154
46

45

45
46
47
50
50

44

Duration
24 hrs

24 hrs
24 hrs
48 hrs
48 hrs
28 days

21 days

21 days
28 days
10 days
14 days
14 days

7 days

Effect
50t .reduction
of 44C02
fixation
LC50
LC50
LC50
LC50
No effect on
survival
LC50

Reproducti ve
I mpa Irment
LC50
LC50
LC50
Bloconcentra-
t ion factor =
2,366
LC50

Result*
(uq/l)
17,000

49,000
27,500
71,000
14,000
565

300

30-100
28
258
3,500
-

16,000

Reference
Malanchuk & Gruendling.
1973

Whit ley, 1968
Whit ley, I96S
Cairns, et al. 1976
Cairns, et al. 1976
Spehar, et al. 1978

Blesinger &
Chrlstensen, 1972
B I es 1 nger &
Christensen, 1972
Spehar, et al. 1978
Anderson, et al. 1980
Nehrlng, 1976
Nehrlng, 1976

Warnick & Bel 1, 1969

-------
Table 6.  (Continued)

Species
Stonefly,
Pteronarcys californica
Stonef ly.
Pteronarcys dorsata
Caddisf ly.
Brachycentrus sp.
Caddlsfly,
Hydropsyche betteni
Rainbow trout.
Salmo qalrdnerl
Rainbow trout (12 mos).
Salmo qalrdnerl
f Rainbow trout.
M Salmo qalrdneri
Rainbow trout,
jajmo gairdnerl
Rainbow trout.
Salmo gairdnerl


Rainbow trout.
Salmo qalrdneri

Rainbow trout,
Salmo qalrdnerl
Rainbow trout (f ingerl Ing) ,
Salmo qalrdnerl
Chemical
Lead nitrate

Lead nitrate

Lead nitrate
Lead su 1 fate

Lead nitrate

-

Lead nitrate
Lead nitrate

Lead nitrate






Lead chloride

Lead nitrate

Hardness
(mg/l as
CaCO^)_
50

46

46
44

135

135

135
135

135


135



99

353

Durat I on
14 days

28 days

28 days
7 days

28 days

14 days

21 days
32 wks

32 wks


29 wks



28 days

19 mos

Result"
Effect (yg/D
B ioconcentra-
tion factor =
86
No effect on
survival

No effect on
survl val
-

565

565
LC50 32,000

Inhibition of
ALA-D activity

Inhibition of
ALA-D activity

LC50 2
Black-tails in
3 of 10
remaining fish
1 ncrease of RBC
and decreases of
RBL, Iron content,
and ALA-D in blood
Al 1 fish with
black tai Is, and
decrease in ALA-D
In blood
LC50

Lordoscol iosls


13

10

,400
120

13


87



180

850

Reference
Nehring, 1976

Spehar, et al.

Spehar, et al.
Warnick & Bel 1,

Hodson, 1976

Hodson, et al.

Hod son , et a 1 .
Hodson, et al.

Hodson, et al.


Hodson, et al.



Birge, et al.

Da vies, et al.




1978

1978
1969



1977

1978
1978

1978


1980



1978

1976


-------
to
I
             Table 6.  (Continued)
             Species

             Rainbow trout (sac fry),
             Salmo galrdnerl

             Brook trout,
             Salve IInus font I nails

             Brook trout (12  mos),
             Salvellnus fontlnalls

             Brook trout
             (embryo -  21  day),
             Salvellnus fontlnalls

             Brook trout (12  mos),
             Salvellnus fontinalls
Red shiner,
Notropis  lutrensls

Goldfish  «12 mos),
Carasslus auratus

Pumpklnseed (>12 mos),
Lepomls glbbosus

Largemouth bass,
Mlcropterus salmoIdes

Fathead minnow,
Plmephales promelas

Fathead minnow,
Plmephales promelas

Mosquitofish (adult),
Gambusla affinls

Mosquitofish (adult),
Gambusla affinls

Marbled salamander,
Ambystoma opacum
Chemical
Lead

Lead
Lead
Lead
Lead
Lead
Lead
Lead
Lead
Lead
Lead
Lead
Lead
nitrate
-
nitrate
chloride
chloride
nitrate
nitrate
nitrate
chloride
chloride
acetate
nl trate
oxide
chloride
Hardness
(«g/l as
CaCOif) Duration
28 19
21
135 14
44 38
44 56
48
135 14
135 14
99 8
400 96
20 96
%
96
99 8
mos
days
days
days
days
hrs
days
days
days
hrs
hrs
hrs
hrs
days
Re-
Effect (JK
Lordoscol losis
Stamina
Inhibition of
ALA-D activity
Elevation of ALP
and ACH activity
Decrease of
hemoglobin and
inhibition of
GOT activity
suit*
l/il
31
14
90
525
58
LC50 630,000
Inhibition of
ALA-D activity
Inhibition of
ALA-0 activity
LC50
LC50 >75,
LC50 7,
LC50 240,
LC50 >56,000,
LC50 1,
470
90
240
000
480
000
000
460
Reference
Davies, et al
Adams, 1975
Hod son, et al
Christens en.
Chrlstensen,
1977
Wai len, et al
Hod son, et al
Hod son, et al
Blrge, et al.
.Tarzwel 1 4 He
1960
Pickering 4 H
1966
Wai len, et al
Wai len, et al
Birge, et al.
. 1976

. 1977
1975
et al.
. 1957
. 1977
. 1977
1978
ndersoi
enders<
. 1957
. 1957
1978

-------
Table 6.  (Continued)

Species
Frog (adult).
Rana plplens

Cil late protozoan.
Cr 1 st 1 gera sp.
Cl 1 iate protozoan,
Cr 1st! gera sp.
Polychaete,
Ophrvotrocha labronlca
Polychaete,
Ctenodrllus serratus
Polychaete (trocnopnore).
a Capltella capitata
oo Polychaete,
nphryotrocha diapema
Polychaete,
nphryotrocha dladema
Oyster,
r.rassostrea virgin lea
Aba lone,
Hal lotus rufescens





Mummichog,
Fnndulus heterocl itus
Hardness
img/l as
Chemical CaCO^L- Duration
Lead nitrate - 30 days

SALTWATER SPECIES
Lead nitrate - 12 hrs
Lead nitrate - 12 hrs
Lead nitrate - >«>0 hrs
Lead acetate - 21 days
Lead acetate - » nrs

Lead acetate - * hrs
Lead acetate - 21 days
i 1 vr
Field study ~ ' 'r

Lead chloride - 6 mos






Lead nitrate

Result*
Effecl
Death


Reduced growth
rate by 8.5*
Reduced growth
rate by 11.7?
LC50
Suppressed
reproduction
LC50
LC50

Suppressed
reproduct Ion
Bioconcentra-
tion factor =
326
Accumulated 21
ug/g wet Wt
*hl le being fed
a brown alga
(Egregla laevi-
gata) which was
pretreated with
1 mg/l
30* depressed
axis formation
In embryos
(liq/l)
100


150
300
1..000
1,000
1,200
14,100

1,000
-


-





100


Reference
Kaplan, et al. 1967


Gray i Ventil la, 1973
Gray 4 Ventl 1 la, 1973
Brown 4 Ahsanul lah,
1971
Relsh 4 Carr, 1978
Relsh, et al. 1976
Reish 4 Carr, 1978

Reish 4 Carr, 1978
Kopf ler 4 Mayer, 1973


Steward 4
Schulz-Baldes, 1976





Weis 4 Weis, 1977



-------
Table 6.  (Continued)
Species Chemical
Soft shell clam. Lead nitrate
Mya arenarla
Mussel, Lead chloride
Mytllls edulis
Mussel, Lead nitrate
Mytllus edulis
Mud crab. Lead chloride
Rh 1 thropanopeus har 1 s I 1
Fiddler crab, Lead nitrate
Uca pug I lator
Sea urchin. Lead nitrate
Arbacia punctulata
™ Shiner perch. Lead nitrate
to Cymatogaster agqreqata
vo 	 	
Alga,
Laminar ia digitata
Diatom, Lead chloride
Phaeodacty 1 um tr I cornutum
Diatom, Lead chloride
Phaeodacty 1 um tr i cornutum
Diatom,
Phaeodacty lum tricornutum
Diatom, Lead nitrate
Skeletonema costatum
Hardness
(mg/l as
CaCO\) Duration
168 hrs
40 days
150 days
2 wks
30-31 days
24 hrs
48-72 hrs
72 hrs
12 days
Effect
LC50
LC50
LT50 for
adults
Delayed larval
development
Bioaccumu la-
tion factor =
20
Few gastru la
developed
21% inhibition
of bra i n
chol inesterase
50-60? reduc-
tion In growth
Completely
inhibited
photosynthesi s
Reduced photo-
synthesis and
respiration by
25-50$
No growth
Inhibition
EC50 for
growth rate
Result*
(ug/l)
8,800
30,000
500
50
100
14
7.8
1,000
10,000
100
1,000
5.1
Reference
Elsler, 1977
Talbot, et at. 1976
Schulz-Baldes, 1972
Beni jts-Claus 4
Benijts, 1975
wels, 1976
Waterman, 1937
Abou-Donia &Menzel,
1967
Bryan, 1976
Woolery 4 Lew in, 1976
Woolery 4 Lew in, 1976
Hannan 4 Patoull let,
1972
Rivkin, 1979

-------
Table 6.  (Continued)
w
U)
o
Species Chemical
Diatom, Lead nitrate
Skeletonema costatum
Phytoplankton, Lead chloride
Platymonas subcordlformls
Phytoplankton, Lead chloride
Platymonas subcordlformls
Phytoplankton, Lead chloride
Platymonas subcordlformls
Phytoplankton, Lead chloride
Platymonas subcordlformls
Alga, Tetramethyl lead
Dunaliella tertiolecta
Alga, Tetraethyl lead
Dunaliella tertiolecta

Hardness
(mg/l as Result*
CaC03) Duration Effect 
-------
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                                     B-38

-------
Mammalian  Toxicology  and  Human Health  Effects



                           INTRODUCTION



     The hazards of lead  exposure  have been  under  intensive  inves-



tigation for many years.  Research  activities  continue  for several



reasons.   First, industrial production and commercial use continues



at a fairly steady rate.  Second,  hazardous  sources  persist  in  the



environment long after the hazard-generating practice has been cur-



tailed.  A good example  is the  persistence  of lead-base paint  in



houses long after the elimination  of lead-containing pigments from



new household  paints.   Finally,  as  biomedical science  in general



and toxicology  in particular continue to push back  the frontiers of



knowledge, indices of toxicity change,  generally with a  consequent



downward  revision  of  what  is considered an  acceptable level   of



human exposure  to environmental  pollutants.



     Reassessment of  acceptable  levels of lead exposure  have been



fairly numerous in recent years.   These have  taken  the form of cri-



teria documents and  of more  academically-oriented reviews.   Some



have been  highly comprehensive,  covering  effects  on  the  ecosystem



in general, as  well as on man [National Academy of Sciences  (NAS),



1972;  Boggess,  1978].  Others have been mainly concerned with  ef-



fects of lead  on man  [World Health Organization (WTTO) ,  1977; U.S.



EPA, 1977;  Hammond,  1977].



     The purpose  of  this review  is  to  summarize  the  literature



which is most  relevant to  the question of what is  an  acceptable



level of human exposure  to  lead via  water.   In  doing  so,  it   is



necessary  to consider  the consequences to human health  of  one  or



another level  of  intake  assignable  to water  and  to the numerous



other  sources.






                               C-l

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                             EXPOSURE
 Natural  Background  Levels
      Lead  is ubiquitous in nature, being a  natural  constituent of
 the  earth's  crust.   The usual concentration in rocks and  in  soils
 from natural sources  ranges  from  10  to 30 mg/kg.   Most  natural
 groundwaters  have concentrations  ranging from  1 to 10 yg/1.   This
 is  well  below  the  United  States'  drinking water  standard of  50
 yg/1.  It is much easier to specify natural  levels  of lead  in  rocks
 and  soil than in vegetation since long-range transoort of lead from
 man-made sources via  the  air  inevitably contaminates both  surface
 soil  and plants growing thereon.  The normal concentration  of  lead
 in  rural vegetation,  however,  ranges  from  0.1 to  1.0  mg/kg  dry
 weight, or 2  to 20 mg/kg ash weight.  Thus, nutrient movement  from
 soil  to  the  organic matter  in  plants  via water does not result  in
 any  noticeable  degree  of  biomagnification.   Again, because of  the
 impact of long-range  transport  of  lead  via  air from man-generated
 sources,  it is only  possible to specify  lowest  concentrations found
 over areas of the globe most remote  from  human  activity.  These  are
 of the order of 0.0001 to 0.001 yg/m3, mostly measured over Green-
 land and  over remote oceans.
     Areas of abnormally high  concentrations of lead  occur  in natu-
 ral ores, usually in conjunction with high  concentrations  of cad-
mium and zinc.  There  is  essentially  no transfer  from natural ore
beds into overlying  streams; and there is none  if the soil,  is even
slightly  alkaline (Jennett, et al.  1977).
                               C-2

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Man-generated Sources of Lead



     Lead consumption  in  the  United States has been fairly stable



from year to  year  at about 1.3 x  10   metric tons.  Approximately



half of  that  consumption has been  for  the manufacture of storage



batteries and one-fifth  has  been for  the  manufacture  of gasoline



antiknock additives, notably tetraethyl lead and tetramethyl lead.



Pigments and  ceramics  account  for  about 6  percent of  annual pro-



duction.  All other major uses are  for  metallic  lead  products or



for lead-containing alloys.  The consumption of  tetraethyl lead and



tetramethyl lead  is declining.   Other  uses that  have significant



potential for  input into  man  are  for  paint pigment  and solder.



Paints applied  to  surfaces will eventually crack, flake or peel.



Children are  known  to  ingest  this  type  of  deteriorating  paint.



Solder also is a potential source of lead exposure  either when used



to seal  water pipe joints or  for joining  seams in metal food and



beverage containers.



Ingestion from Water



     Lead does  not  move  readily  through  stream   beds  because  it



easily forms  insoluble  lead  sulfate and carbonate.   Moreover,  it



binds avidly  to organic ligands of the dead and  living flora and



fauna of stream beds.   Nonetheless,  under  special circumstances,



lead does have considerable potential for hazardous exposure to man



via drinking water.  In areas where  the home water  supply is stored



in lead-lined tanks or  where it is conveyed to the water  tap by lead-



pipes, the concentration may reach  several  hundred micrograms per



liter or even  in  excess  of  1,000   yg/1  (Beattie,  et al.   1972)  .



There is a  definite positive correlation between the concentration
                               C-3

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 of lead in the domestic water supply and the concentration of lead
 in the blood.   The concentration  of lead  in  the water  conveyed
 through lead  pipes  is dependent on a number of factors.  The longer
 the water  has  stood in the pipes, the higher the lead  concentration
 (Wong  and Berrang,  1976).  The  lower the pH of  the  water and the
 lower  the  concentration of dissolved salts in the water, the great-
 er is  the solubility  of lead in the water.   Leaching of  lead from
 plastic pipes has  also been  documented  (Heusgem  and E)e  riraeve,
 1973).   The  source of  lead was probably lead  stearate,   which  is
 used as a  stabilizer in the manufacture of polyvinyl plastics.  The
 magnitude  of the problem of excessive lead in tap water is not ade-
 quately known.  In one recent survey of 969 U.S.  water systems, 1.4
 percent of all tap water  exceeded  the  50 ug/1  standard  (^cCabe,
 1970) .  Special attention should  be  given in water quality surveil-
 lance  to  soft water  supplies,  especially  those  with a PH < 6.5.
 Future  survey  work  should  also indicate  whether  or not the  water
 was filtered before analysis.   This  appears to be a common practice
 among water analysts.   Since a substantial  fraction of  the  lead  in
 drinking water probably is in  particulate form,  filtration prior  to
 analysis could give  deceivingly low analytical values  especially  if
 a  substantial  fraction  of  the particulate lead  in water  is avail-
 able for absorption.  However,  "drinking  water" analyses are usual-
 ly performed in unfiltered water and hence represent  total  lead.
 Ingestion  from Food
     It is generally held that food constitutes  the major  source of
lead ingested  by people.  Raw  fruits  and  vegetables  acquire  lead by
surface deposition  from  rainfall,  dust  and  soil,  as  well as  from
                               C-4

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uptake via the root system.   The  relative contribution of these two



sources varies greatly depending  upon whether the edible portion is



leafy  or  not.   Furthermore,  the  nature  of  food  processing  may



either lower or raise the concentration in the raw product - e.g.,



washing as  compared  to  packing  in  metal  cans  with  lead  solder



seams.  There is no evidence  of biomagnification  in  the food chain,



e.g.,  from  aquatic vegetation to the  edible  portions  of fish and



shellfish.  Therefore, fish do not constitute an unusually signifi-




cant source of lead in man's diet.



     Schroeder, et  al.  (1961)  reported 0  to 1.5  mg/kg of lead for



condiments, 0.2 to  2.5 mg/kg for fish  and seafood,  0 to 0.37 mg/kg



for meat  and  eggs,  and  0  to  1.3  mg/kg for vegetables.   Other more



recent  studies  have confirmed this  observation.   Many  foods and



beverages are packed  in metal cans which have a  lead-soldered side



seam and  caps.   The concentration of  lead in the contents is sub-



stantially  higher  after packing  than  before,  and  is  also higher



than the  same product  packed in  glass  [Mitchell  and Aldous, 1974;



U.S.  Food and  Drug Administration  (U.S.   FDA), 1975].   In some



instances, the lead probably  leaches from  the solder  through cracks



or pores  in the protective shellac coating applied to the  inside of



the can.  In many other instances, however, microscopic pellets of



lead  splatter  inside  the  can during  the soldering process.  Their



availability  for absorption  may  differ substantially from that of



lead leached  into  solution.



     Milk has  been studied  extensively as to lead  content because



it  constitutes  a  substantial fraction of  the diet  of  infants and



young  children.  Whole raw cow milk has a  concentration of about  9
                               C-5

-------
 ug/1 (Hammond  and Aronson,  1964) whereas market milk has an average
 of  40  yg/1 (Mitchell and Aldous, 1974).  Evaporated milk  has  been
 variously reported  to contain  an average  of  202  ug/1  (Mitchell and
 Aldous,  1974),  110  +  11 yg/1 (Lamm and Rosen, 1974), and 330 to 870
 yg/1 (Murthy and Rhea,  1971).
     The daily dietary  intake  of lead  has been estimated by numer-
 ous  investigators,  using  either  the  duplicate portions  approach or
 the  composites  technique wherein  theoretical   diets  are  derived
 using nutrition tables.  The results  are generally consistent,  con-
 sidering variations  in  body  size and metabolic rates.   Thus, Nord-
 man  (1975)  reported  an  average daily intake  of  231 yg  Pb  for  Fin-
 nish adult  males and  178  yg  Pb for adult  females.   This  is consis-
 tent with a British study reporting  274 yg Pb/day  for young  adults
 (Thompson,  1971) and  with a  Japanese study reporting 299  ug  Pb/day
 for  adult males doing medium  work  (Horiuchi,  et  al.  1956).    The
 first  two studies  (Nordman,  1975;  Thompson, 1971)  described  the
 duplicate portions  technique whereas the third  (Horiuchi, et  al.
 1956) used the composites approach.   Kolbye,  et al.  (1974)  analyzed
 the  difficulties inherent in applying this approach.  Kehoe  (1961)
 reported  an average  intake  of  218  yg  Pb/day for sedentary  men.
 This is not consistent,  however,  with two other American  studies of
 daily fecal lead excretion (Griffin,  et  al. 1975;  Tepper  and Levin,
 1972) .    From the  lead balance  studies of Kehoe  (1961) ,  it can be
 estimated that  gastrointestinal  absorption of  lead approximates  8
percent.  Making this adjustment, daily lead intake from  the  diet
based on  fecal lead excretion  would be 113  ug  in sedentarv adult
males (Griffin, et  al. 1975)  and  119  yg  in women  (Tepper and Levin,
1972) .
                               C-6

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     Many studies  of  dietary  lead intake are somewhat vague as  to
whether water consumption  was included  in  the  estimates.  Others
specify "food and beverages."
     The dietary  intake  of lead  in infants and young children has
not been  studied  as extensively  as  it has in  adults.   Using the
duplicate diet approach,  Alexander, et al.  (1973)  estimated a range
of 40 to 210 yg/day of lead for children ranging  in age  from three
months to 8.5 years.  Horiuchi, et al.  (1956) estimated  126 yg/day
of lead for youngsters 10 months old.  These seemingly high values
compared  to adults  are  not  too  surprising considering the high
caloric and fluid  requirements of  children in  proportion to their
weight.
     A bioconcentration factor (BCF)  relates the concentration of a
chemical in aquatic  animals to the concentration  in  the water  in
which they live.  An appropriate BCF  can be used with data concern-
ing food  intake to calculate the amount  of  lead which might  be
ingested from the consumption of fish  and  shellfish.  Residue data
for a variety  of inorganic  compounds  indicate that bioconcentration
factors for the edible portion of  most aquatic  animals are similar,
except that for some compounds bivalve  molluscs  (clams, oysters,
scallops, and mussels) should be  considered a  separate group.    An
analysis (U.S.  EPA,  1980)  of  data from  a  food  survey  was used  to
estimate that the  per  capita  consumption of freshwater  and estua-
rine  fish  and shellfish is 6.5  g/day  (Stephan,  1980).    The  per
capita consumption of bivalve  molluscs is 0.8 g/day and that of all
other freshwater and es'tuarine fish and shellfish is 5.7 g/day.
                               C-7

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     Several bioconcentration  factors are available  for  the  edible

portions of bivalve molluscs:
         Species
  BCF
  Oyster,
  Crassostrea virginica

  Oyster,
  Crassostrea virqinica

  Oyster,
  Crassostrea virqinica

  Auahaug, hard clam,
  Mercenar ia mercenaria

  Soft shell clam,
  Mya arenaria

  Mussel,
  Mytilus edulis

  Mussel,
  Mytilus edulis

  Mussel,
  Mytilus edulis

  Mussel,
  Mytilus edulis

  Mussel,
  Mytilus edulis
  536


   68


1,400


   17.5


  112


  650


  200


2,570


2,080


  796
     Reference
Zarooqian, et al.
 1979

Pringle, et al. 1968
Shuster and Pringle,
 1969

Pringle, et al. 1968
Pringle, et al. 1968
Schulz-Baldes, 1974
Talbot, et al. 1976
Schulz-Baldes, 1972
Schulz-Baldes, 1972
Schulz-Baldes, 1972
     The geometric mean bioconcentration factor  for  lead in bivalve

molluscs is 375, but no data are available for appropriate tissues

in other aquatic animals.   Based  on  the available data for copper

and cadmium,  the mean BCF value  for other species  is probably about

one percent of that for bivalve  molluscs.  If  the  values of 375 and

3.8 are used  with  the  consumption data, the  weighted  average BCF

for lead  and  the  edible portion  of all  freshwater  and  estuarine

aquatic organisms consumed  by Americans is calculated to be 49.
                               C-8

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 Inhalation
      The  third major obligatory source of lead in the general popu-
 lation  is ambient air.  A great deal of controversy has been gener-
 ated  regarding the  contribution of  air  to  total  daily lead absorp-
 tion.   Unlike the situation with food  and water, general  ambient
 air lead  concentrations vary greatly.   In  metronolitan areas aver-
 age air lead  concentrations of 2  ug/m   with  excursions of  10 ug/m
 in  areas  of heavy traffic or  industrial point sources  are  not  un-
 common, whereas  in  nonurban areas,  average air lead  concentrations
 usually are of the  order  of 0.1 ug/m .   In addition,  people are so
 mobile  that static  air sampling  devices are not  very useful  for
 estimating  the integrated air lead  exposure  of urban  populations.
 Dermal
     Exposure  of the  skin  to lead probably  is significant only
 under special circumstances such  as among  workers in contact with
 lead-based  gear  compounds or greases,  or  blenders  of alkyl lead
 fuel  additives.   It is very  unlikely  that  the  concentrations  of
 lead  in water or  air  are  sufficient to make  dermal contact  a sig-
 nificant route of exposure.
 Miscellaneous Sources
     Among adults not  occupationally exposed  to lead,  there  are sev-
 eral sources of lead which may assume  clinically significant pro-
portions.   Perhaps the most serious widespread problem  is the con-
 sumption of illicitly distilled whiskey  (moonshine) which is often
heavily contaminated with  lead.  Many cases of frank lead poisoning
have been  documented.   The concentration  of lead  in moonshine whis-
key commonly  exceeds  10 rag/1, or 2,000 times the  drinking water
                               C-9

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standard.  Storage of acidic beverages  in  improperly glazed  earth-



enware has caused severe,  sometimes fatal poisoning  in  the consumer



(Klein, et al. 1970; Harris and Elsea,  1967) .



     Occupational exposure to  lead may  be  quite excessive.   Thus,



in  primary  lead smelters, the air lead concentration may  exceed



1,000 jjg/m .   A similar situation  exists  in  some storage battery



manufacturing plants.  Other hazardous  occupations  include welding



and cutting of  lead-painted metal structures, automobile radiator



repair, and production of lead-base paints.   In these  occupations,



the principal hazard is generally  considered  to be  from inhalation



of  lead fumes  and dusts.   Hand-to-mouth transfer is probably sig-



nificant.




     The  hazard  of  lead  to children  is of  considerable concern.



The number of children  excessively exposed to lead  from miscella-



neous sources is impressive.  Thus, federally  assisted  lead screen-



ing programs reveal that  excess lead  absorption was found in 11.1



percent of 277,347  children  screened in 1973.   Blood  lead  levels



(PbB)  were reported  to be  in excess of  40 yg/dl.  The percentage has



fallen since  then,  being 6.4  percent in  1974  and  6.5 oercent  in



1975 (Hopkins and Houk,  1976).  By 1976  the problem  had not changed



appreciably since  1974  and 1975.  In  that  year,  8.7  percent  of



500,463 children screened had  PbBs ^ 30 yg/dl  and  2.7 percent  or



13,604 children  had  PbBs  > 50  yg/dl  (Center  for  Disease Control,



1977) .




     It has long been held that the major  source of elevated lead



exposure   in infants and young  children  is  lead-base paint  in  the



interior  of home and in the soil  surrounding  the  homes.   More  re-
                              C-10

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 cently, the high lead content of soil and street dust attributable
 to the fallout of lead from automobile exhaust has become suspect.
 Thus,   in  the  1972  publication Airborne  Lead  in Perspective (NAS,
 1972) , it  is pointed out that the daily ingestion of 44 mg of street
 dust at 2,000 yg Pb/g would  suffice  to  elevate  the  PbB of a young
 child   from 20  yg/dl  to 40  yg/dl.   In  a survey of  77  midwestern
 United States  cities,  it was  found  that  the average lead concentra-
 tion in the street  dust  of  residential  areas  was 1,636  yg/g  and
 that in commercial  and industrial areas  the average  concentrations
 were,  respectively,  2,413  yg/g and  1,512 yg/g  (Hunt,  et al.  1971).
 Soil along the  shoulder of heavily-traveled roadways also is heavi-
 ly contaminated,  although  most values  found  have been in the range
 of hundreds of micrograms per gram rather than thousands (for exam-
 ple, Lagerwerff and  Specht,  1970).
     The relative contribution of soil, automotive exhaust fallout,
 and paint  to lead exposure in children remains  uncertain.  There  is
 no question that children in the age range of 1 to 5 years, in which
 the  problem of  elevated PbBs exists,  do  indeed  exhibit pica, the
 habit  of mouthing or ingesting nonedible objects, e.g.,  pieces  of
 plastic, gravel, cigarette butts,  etc.  (Barltrop,  1966).   The  habit
 also appears to be more prevalent among children  who  have  elevated
 PbBs than  among those  who  do not (Mooty, et al.  1975) .   There  is
 strong  evidence  that paint is a major source  of lead in children
with pica.   Thus,  Sachs (1974)  reported that 80 percent of patients
seen because of evidence of excessive  lead absorption  had a history
of eating paint or plaster.   Hammond,  et al.  (1977)  reported that
among 29 children with elevated PbBs (_>40 yg/dl) selected at ran-
                              C-ll

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dom from a  lead  screening  program,  all but one came from 14 homes



classified as having high hazard  for  lead-base  paint, either exter-



ior or interior (Table 1).   High  hazard consisted  of  there being at



least one accessible painted surface  with _^_0.5 percent Pb, peeling



or otherwise  loose.   The medium  classification consisted of  > 0.5



percent Pb, but  the  painted  surface  was generally tight.  In  this



study there was  found  to be a highly significant correlation  (p =



0.007) between paint hazard classification (low, medium/ high) and



fecal lead excretion, but no correlation between fecal lead excre-



tion and traffic density (vehicles per day) in the vicinity of the



home  (p =  0.41).   Unfortunately, the  correlation between traffic



density and the  lead content  of  soil and  dust  was not determined.



Thus, the data are merely suggestive.



     Ter Haar and Aronow (1974)  reported  that  elevated  lead expo-



sure in eight children,  hospitalized  for excessive lead absorption,



could not  be  caused  by  lead  from  fallout of  airborne  combusted



automobile exhaust.   Six of the eight children had distinctly  ele-



vated fecal lead  excretion  as compared to nine  control children,


                       210
yet their excretion of    Pb, a marker for aerosol fallout,  was no



different from that  of  the  controls.  However,  the children in  this



study were supposed to have ingested paint.  The criteria were one



or all of  the following:   (1)  x-ray  showed radio  opaque materials



in the gut,  (2)  history of pica,  (3)  elevated PbB,  and (4)  x-ray



showed Pb lines on the long bones.



     There is other  evidence,  however,  which  sugqests that dust and



soil are,  under  some  circumstances at least, significant sources of



lead for infants and children and that their effect  is additive to
                              C-12

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                                                  TABLE  1



                           Classification of Home Environments as to Lead Hazard'
n
i
Family
A
B
C
D
F
G
H
J
L
M
N
P
R
S
Paint, Lead
Hazard Interior
Dust
H
H 20
H
H
II 0.3(1)
M
H
H
H
Mi) ; H(E)
H
M(I) ; H(E)
H
MI) , H(E)
Concentration, %
Exterior
Dust
0
0
-
0
0
0
4
1
-
-
-
-
0
-
.45
.11

• 3(
• 1 (
.!(
.0(
• 9(




.6(

(2)
(2)

D
D
D
D
1)




1)

, c
d . w.



Soil
0.
0.
0.
0.
0.
0.
0.
-
0.
0.
-
-
0
-
12
06
07
3(
1(
2(
9(

05
(
(
(
2
1
3)
2)
D
)
)
D
2

(
1(3








)

D
)




Vehicles -,
per d. x 10
2.

10
2.
= 0
= 0
4
1
2.
0.
1
2.
4
5
5-5
30
- 15
5-5
.5
.5
- 6
- 2
5-5
5-1
- 2
5-5
- 6
- 7.5
       Source:  Hammond, et al. 1977



       H = high;  M = medium;  L = low;   (I) =  interior;   (E)  =  exterior.   Absence  of (I)  or (E)

       designation means that both conformed to  the designated classification  of H,  M or  L.


       ••

       'Numbers  in parentheses indicate number of  environmental samples.

-------
that produced- by  inhalation.   The best evidence  is  orovided in a
study of a  population of children residinq in the immediate vicini-
ty of a  large  secondary lead  smelter  near  El Paso, Texas (Landri-
gan, et  al.  1975).   Sixty-nine  percent  of  one-  to  four-year-old
children living within  one  mile of the El  Paso  smelter had blood
lead levels greater than or  equal to 40 yg/dl, the level then con-
sidered  indicative of increased lead absorotion.   By contrast, the
prevalence of  blood lead levels  greater than or  equal  to 40 yg/dl
among 98 adults living  in the  same  area was 16 percent.  The geo-
metric mean lead concentration of soil  in  that location was 1,791
ppm and  that of house dust was 4,022 opm.  Lead based paint was not
a problem.   Therefore it seems likely  that a proportion  of the lead
intake  in  the  children  living in El Paso was  oral rather than by
inhalation and  that  the net effect of the  two routes  of exposure
was to place children at a considerably increased  risk  of lead up-
take than adults.   The mere  presence of high concentrations of lead
in  soil  accessible to children  is not enough  to create a hazard.
Thus, children living  in  British homes built  on soils containing
8,000 yg Pb/g  showed  a  considerably smaller elevation  of PbB than
was found in the El Paso study  (Barltrop, et al. 1974) .   This  may be
explained by other factors,  e.g. rainfall  and soil composition.  El
Paso, Texas is a hot, dry, windy town, whereas Britain  has consid-
erable  rainfall, probably resulting in a heavy protective cover of
vegetation.
     Certain  miscellaneous  sources  of lead  are unique  to children
by  virtue  of  the pica  habit.   These include  colored  newsprint
 (Joselow and Bogden, 1974)  and other  items  to  which  lead-base oig-
                               C-14

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 ment  is applied.  In addition, pica is  known to occur in some women,



 particularly  during  pregnancy.



                         PHARMACOKINETICS



      In characterizing the accumulation of lead  in  the  body under



 various  circumstances of  exposure,  experimental  animal data  are



 useful for establishing relevant principles.  The specific rates of



 transfer  into,  within,  and outside of  the animal system  cannot  be



 relied upon to  reflect, with any reliability,  the situation in man.



 Only  human data will serve to indicate  how much lead, in  what form,



 and by what  route the accumulation of  lead in specific  organs  and



 systems would  occur.   This restriction has imposed  severe  limita-



 tions on knowledge concerning lead metabolism in man.  Only certain



 human biological  fluids and  tissues are accessible for  sampling,



 except after death.  The human cadaver,  in turn,  has its  own limi-



 tations, chiefly that the  precise history of lead  exposure prior  to



 death  is  not  known.   Ante  mortem studies of  lead metabolism  in



 human volunteers,  on  the  other  hand,  have their own limitation.



 They provide a  substantial amount  of knowledae concerning  the  sub-



 ject,  but  extrapolation of the data to  the general population  is



 tenuous.   Population studies materially  overcome  this  restriction,



 but at the expense of  precision  and  detail of knowledge.  By com-



 bining data  from  a.11 sources, a  reasonable  understand: ^a of lead



metabolism does emerge, however.   The  ultimate  objective of this



 section is to relate contribution of source (water)  to total expo-



 sure.   As will  be seen, this  can  only  be achieved by using  incre-



mental PbB as  an index of water exposure - the  approach  also  used by



 the U.S.  EPA in assessing  air as a source of lead exposure.
                              C-15

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     In reviewing  the  metabolism of lead  in  man,  it is generally



assumed that all inorganic  forms  once  absorbed  behave in the same



manner.   There  is  no evidence to suggest  that  this assumption  is



erroneous.



Absorption



     The  classic studies  of lead metabolism  in man, conducted  by



Kehoe  (1961) indicate  that,  on the average and with considerable



day to day excursions,  approximately 8 percent of the normal diet-



ary lead  (including  beverages)  is absorbed.  This  conclusion was



reached as  a result of  long-term balance  studies  in volunteers.


                                                  ?04
Recent  studies  using  the  nonradioactive  tracer  "  Pb  have con-



firmed this conclusion  (Rabinowitz,  et  al.  1974).  It is;  of special



significance that these same  workers found  that  absorption of doses



of lead nitrate, lead  cysteine,  and lead  sulfide  eaten after a  6-



hour fast  and  followed by  another  6-hour  fast  was up  to 8-fold



higher than  when the lead was  taken with  meals  (Wetherill, et al.



1974).   This finding has been  confirmed  in mice using small doses



of  lead  (3  yg/kg)   but not  when  using large doses  (2,000 ug/kg)



(Garber and  Wei, 1974).   Thus, lead in water and  other beverages



taken  between meals may have  a  far  greater  impact  on  total lead



absorption than  lead taken with meals.



     The gastrointestinal absorption of  lead  in young children  is



considerably greater  than  in  adults.   Alexander,  et  al.   (1973)



found that dietary  lead absorption was approximately 50 percent  in



eight  healthy children three  months  to  8.5  years  of age.   This



finding has  been confirmed  using  a  larger  number  of subjects less



than 2  years of  age (Ziegler, et al. 1978).  It  is worth noting too
                               C-16

-------
that  the same observation  has been made  using infant rats,  thus
suggesting a similarity  in  lead absorption characteristics  (Forbes
and Reina, 1974; Kostial, et al.  1971).
     Numerous  factors  influence  the  absorption of  lead  from  the
gastrointestinal tract.  Low dietary Ca and Fe and  high dietary fat
enhance  lead  absorption  in experimental  animals   (Sobel,  et  al,
1938;  Six  and  Goyer,  1970, 1972).   Lead absorption has also  been
shown  to be enhanced in  experimental animals  by high  fat, low  pro-
tein,  and high protein diets,  and to be decreased  by high mineral
diets  (Barltrop and Khoo, 1975) .   There  also has been shown to be an
inverse  relationship between dietary  lead  absorption and the  cal-
cium content of  the diet of infants  (Ziegler,  et  al. 1978).   The
chemical nature of  the lead also  has an  influence on  the degree  of
absorption.   Thus,  Barltrop  and Meek  (1975)   reported  that,  in
mature rats in  an acute experiment,  lead  naphthenate,  lead octoate,
and lead sulfide were  absorbed  only two-thirds as well as  lead  ace-
tate and  that  elemental  lead  particles,  180  to 250  ym,  were  ab-
sorbed only about 14 percent as well.  Lead phthalate  and lead  car-
bonate  were  absorbed  somewhat better  than   lead  acetate.     Some
attention has also been given to the availability for  absorption  of
lead in dried paint. The absorption of  lead naphthenate is reduced
50 percent  (in  rats)  as  a  result  of  incorporation  in paint films
(Gage and Litchfield,  1969).  Similarly, it has been found in  mon-
keys that lead  octoate  in dried ground paint is  not absorbed  to the
same extent  as   lead octoate not incorporated  into paint (Kneip,  et
al. 1974) .
                              C-17

-------
     There are serious problems in reqard to assessing the absorp-
tion of lead via the respiratory tract.  The fractional deposition
of  inhaled  aerosols is  relatively  easy to measure,  even in man.
The problem lies in determining the fate of the aerosol Particles.
To  varving  degrees, depending  on  their  solubility  and  particle
size, these particles will be absorbed  from  the respiratory tract
into the  systemic  circulation,  or  they will  be transferred to the
gastrointestinal tract  by swallowing  following  either  retrograde
movement up the pulmonary bed or by drainage into the pharynx from
the nasal passages.  Unfortunately, the particle size distribution
and solubility of  lead  aerosols varies tremendously, depending on
their origin and residence  time in the air.   All  of these diffi-
culties have frustrated  previous  attempts  to  assess the impact of
lead inhalation on  the body burden of  lead.   It has always proved
necessary to fall back  on a more indirect approach to the Problem,
whereby the  impact  of air lead concentration on the blood lead con-
centration is measured.   In order for this approach to be meaning-
ful, certain  conditions and  restrictions  must  apply.    First,  a
fairly large population  of subjects is needed in order to overcome
the background noise resulting from the variable impact, of dietary
lead on the  subject's PbBs.  Second,  it  is necessary to monitor the
air breathed by  the subjects continuously  and  for  a substantial
period of time.  Third, the subjects must have  been  in  the air envi-
ronment  being  evaluated  for  at  least  three  months  in  order  to
assure reasonable  equilibration of air  lead  versus PbB.   If  all
these conditions are achieved, the results are only applicable for
the particular type of  lead  aerosol  under study.   Thus,  it would
                              C-18

-------
 not  be  reasonable  to extrapolate  data obtained  in a  peculation
 breathing city  air  to a  population of industrial workers for whom
 the greatest  source of input might be lead oxide fumes.  Needless
 to say, these restrictions are so severe that  very few studies have
 been performed which would allow one  to make  a reasonable iudgment
 concerning the relative importance of  diet  versus air as  sources of
 lead absorption.   An  assessment  of  available  information  is de-
 ferred to the end of this section on  lead metabolism.
 Dermal
      Very few studies  concerning  the  dermal absorption  of lead in
 man or  experimental  animals are available.  Once again, the problem
 of the chemical form of lead  comes  into  play.  In an early study of
 dermal  absorption of  lead  in rats, it  was found that  tetraethyl
 lead was  absorbed  to a  substantially greater degree than lead arse-
 nate, lead oleate, or  lead acetate  (Laug and Kunze,  1948).  Differ-
 ences  in  the degree of absorption  among  the oleate,  arsenate,  and
 acetate were not significant.  In a more recent  study,  absorption
 of lead acetate and  lead  naohthenate  through the intact  skin  was
 demonstrated,  based  on concentrations  of lead attained  in various
 organs  as compared to  controls  (Rastogi  and  Clausen,  1976).   There
 seems to  be  little question  that  lead  can be  absorbed through  the
 intact  skin,  at  least when applied in high concentrations such as
 were used in the Rastogi study  (0.24M).
 Distribution
     The  general features of lead  distribution  in  the  body are
well-known,  both from  animal  studies and from  human  autopsy data.
Under circumstances of long-term exposure, approximately 95 percent
                              C-19

-------
of the total 'amount of lead in the body  (body burden) is localized



in the  skeleton after  attainment  of maturity.   By  contrast,   in



children, only  72  percent is in bone  (Barry,  1975).   From animal



studies it also appears that  the  very young  retain lead to a great-



er extent than  adults  (Jugo,  1977) .   The amount in bone increases



with old  age  but the  amount  in  most soft  tissues,  including the



blood,  attains  a  steady  state  early  in adulthood  (Barry,  1975;



Horiuchi and Takada, 1954).  Special note should be made regarding



the  kinetics  of  lead  distribution  with  reference to  the  blood.



When human  volunteers  are introduced  into  a new  air environment



containing substantially higher concentration of lead  than the ore-



vious one, the concentration  of lead  in  the  blood rises rapidly and



attains a new apparent steady state  in about 60 to 100 days (T'ola,



et al. 1973; Rabinowitz, et al. 1974; Griffin, et al. 1975).  This



is probably only  an apparent steady state  rather  than  a true one



because the  kinetics of disappearance of  lead  from the blood differ



depending upon whether the high level was maintained for months  or



for years.  When men were  placed  in a high lead environment for 100



days and  then returned  to a  low  lead environment,  the PbB concen-



tration returned  to the  pre-exposure  level with  a  disappearance



half-time of  only  about  six  weeks.   By  contrast,  the rate  of PbB



decrement in workers who retire from  the  lead  trades is much longer



(Haeger-Aronsen, et al. 1974; Prerovska and Teisinger, 1970). This



suggests  that true  equilibrium between  the  blood  compartment and



bone compartment is only slowly attained under constant state expo-



sure conditions.
                               C-20

-------
     The distribution of  lead  at  the  organ  and  cellular  levels  has



been studied extensively.  In blood,  lead is primarily localized in



the  erythrocytes.   The ratio  of  the  concentration of lead  in  the



cell to lead in the plasma is approximately 16:1.   Lead crosses  the



placenta  readily.   The concentration of  lead  in  the blood  of  the



newborn is quite similar  to  the maternal  blood  concentration.   The



approximate ratio of fetal to maternal PbB is somewhat greater than



one  (Clark, 1977;  Schaller, et al. 1976).   Studies  of  the  subcellu-



lar  distribution of  lead indicate that distribution occurs  to  all



organelles, suggesting  that  all  cellular  functions  at least have



the opportunity to interact  with  lead.



Metabolism



     Upon  entry into  the body,  lead compounds occurring  in  the



environment dissociate.   Therefore,   no  question  of  metabolism of



the  pollutant  is  involved.    The  one exception is  the  family of



alkyl lead compounds, principally tetramethyl  lead and tetraethyl



lead.  These are dealkylated to form trialkyl and dialkyl metabo-



lites, which are more toxic  than  the  tetraalkyl forms  (Bolanowska,



et al. 1967).



Excretion



     The  numerous  studies reported  in the  literature concerning



routes of  excretion in experimental animals  indicate wide  interspe-



cies differences.    In  most  species,  except the  baboon, biliary



excretion predominates  over  urinary  excretion  (Cohen, 1970).   it



also appears that  urinary excretion  predominates  in  man (Rabino-



witz, et al.  1973).   This conclusion,  however, is based  on data



from one volunteer.
                              021

-------
Contributions of Lead from Diet versus Air to PbB



     Great concern  has developed  in  recent  years  regarding  the



impact of air lead exposure on human health in the general pooula-



tion.  Analysis of the contribution  of  ambient  air to lead intake



by man has taken the  form  of  an analysis of air lead versus PbR for



reasons explained in the  section on  lead  absorption.   An analysis



of all  available  data  bearing on  this  guestion  first appeared in



the Environmental Health  Criteria  3  Lead  published by WHO (1977)  .



A more rigorous and detailed  analysis was  published subsequently in



Air Quality Criteria  for Lead  (U.S. EPA, 1977) .



     Most of  the  data  bearing on  the  question  of air lead versus



PbB are deficient in one  of  two major respects.   The most serious



and frequent  deficiency is the lack  of continuous air sampling in



the breathing zone of the subjects.  An almost equally serious but



less  frequent deficiency  is  the lack of variation in the air lead



concentration over the range of interest.  This is, unfortunately,



a problem seen mainly in  the clinical studies (as  opposed to popu-



lation  studies)  where the  number  of  subjects  is  quite limited.



Another problem, also limited to the  clinical  studies,  is the arti-



ficial nature of the lead aerosol  utilized.   In spite of  all these



apparent limitations, calculations from the epidemiologic and labo-



ratory data  sources  indicate  a fairly narrow  range of blood Pb to



air Pb ratios, namely 1 to 4 ug/dl for  every  microgram of air lead



per cubic meter (yg/m ).  This blood  Pb to air Pb  ratio  appears to



be higher for children than adults (Table 2) .



      Among all  the studies,  the only one  that  satisfied all cri-



teria for design was the  one by Azar,  et  al.  (1975).  It should be
                               C-22

-------
                                                           TANLE 2
                               Estimated Blood Lead to Mr Lead Ratios for Four Air Lead Concentrations
O
I
NJ
U)
Study
Rpidemio logical
A7.arh
Tepper- Levin0
Nordman
Nordmanc
Fuqasc
Johnson0
Johnson
Tsuchiya°
Goldsmith0
Goldsmith0
Yankel-von Lindern
Chamberlains-Williams
Da inesc
Clinical
Gri ff inc
Griffin0
Rahinowi tzc
Gross
Chamber la in
Chamberlain -Kehoe
Population

Adult males
Adult females
Adult males
Adult females
Adults
Adult males
Adult females
Adult males
Children males
Children females
Children
Adul ts
niack females

Adult males
Adult males
Adult males
Adults
Adults
Adults
Sampl e
Size

149
3 ,008
536
478
330
64
107
591
202
203
879
482
(unknown)

11 P 10.9
14 e 3.2
2
(21,000 person-days)
7
5
Ratio at
Air Lead Concentrations
|iq/rn
1.0 2.0 3.5 5.0

2.57 1.43 0.89 0.66
0.87 0.92 I. 00 1.08
(0.42)
(0.11)a
(2.64)
(0.80)
(0.60)
(3.84)
(2.30)
(1.70)
1.16 1.21 1.27 1.37
(1.10)
(2.30)

(1.40)
(1.65)
(1.7. 2.5)
(0.38)
(1.20)
(1.10)
            "Source:  U.S. EPA, 1977

             Author's regression equation evaluated at specific air  lead
            °IJ.S. KPA calculation
             Author's calculations
            °Ratios presented  in parentheses are not calculated from regression  equation

-------
noted that the  regression  eauation  developed to describe the data
(log PbB = 1.2557 + 0.153  (log ug Pb/m3))  has a slope of less than
one.  Thus, the incremental rise in PbB for each 1 ug Pb/m  in air
becomes progressively smaller.  This relationship is consonant with
experimental animal data showing that over a wide range of dietary
lead levels  the incremental rise  in  PbB  decreases  progressively
proportional to  the  rise  in dietary  lead  levels (Prpic-Maiic, et
al. 1973; Azar, et al. 1973).  It also is consonant with the World
Health Organization analysis of data on  air  lead exposure  in a bat-
tery plant (WHO, 1977) .
     The Azar  data have been analyzed as  to dose  response by the
U.S. EPA (1977) and are presented in Table 3.
     So far as the contribution of other sources of lead to PbB is
concerned, a quantitive  analysis such  as has  been done  for air lead
is  simply  not  possible  using the  data  currently available.   An
estimate of the total dietary contribution to PbB was attempted by
WHO  (1977) recently  (Table 4).
     So  far  as the  specific contribution of  water  is concerned,
information is even more scarce than for total  diet.  Estimates of
the contribution of lead in water to PbB have been reported  in  four
separate studies.   The  first of these was  oublished  in 1976  (El-
wood, et al. 1976) .  A linear regression was  calculated  for  PbB and
water  lead using  "first run"  morning  tap water in  129 houses in
northwest  Wales.   Blood  lead concentrations  were determined  for an
adult  female  resident in each  house.   The regression drawn was as
follows:
             PbB (ug/dl)  = 19.6 + 7.2  (mg  *>b/l water)
                               C-24

-------
                     TABLE 3

       Estimated Percentaqe of Population
Exceeding a Specific Blood Lead Level in Relation
           to Ambient Air  Lead Exposure
Air Lead,
yg/m
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
6.0
7.0
8.0
20.0
yg/di
15.22
26.20
34.12
40.23
45.15
49.23
52.69
55.67
58.27
60.57
64.45
67.63
70.28
Percent Exceeding
Blood Lead Level of:
30.0
ug/dl
0.59
1.67
2.88
4.12
5.35
6.57
7.75
8.90
10.01
11.09
13.16
15.10
16.92
40.0
ug/dl
0.02
0.07
0.16
0.26
0.38
0.51
0.66
0.81
0.97
1.14
1.48
1.83
2.20
                     C-25

-------
                                               TABLE 4

                    Comparison of Daily Oral Lead Intake With PbB  Levels3
Study Design

Fecal
excretion
Duplicate
Duplicate
o
i
Compos
ites
portion
portion
technique
Oral Intake
(yg/day)
119C
230
180
505
(women)
(men)
(women)
(men)
PbBb
(yg/100 ml)
15
12
7
34
.3
.3
.9
.6
PbB
100
oral
13
5
4
6
per
yg
Pb
.0
.4
.4
.8
Reference
Tepper
Nordman
Nordman
and Levin (1972)
(1975)
(1975)
Zurlo and Griffini, 1973d
d
 Source:   WHO,  1977

 Contributions  of air  to PbB  levels  are not reported  in most of these studies  and could not be
 subtracted  from total PbB  levels.

'Calculated  from daily faecal  excretion of  108  yg  of  lead  assuming gastrointestinal absorption
 10  percent

 Pb-B  levels from Secchi, et  al.  1971

-------
 The regression  selection  seems inappropriate  from  examination of
 the scattergram (Figure 1) .   A curvilinear model would  have  been
 more appropriate or  at least should have been tested,  particularly
 since  the authors'  linear model extrapolates to  PbB 19.6  ug/dl,  a
 rather  high  baseline value for non-occupationally exposed women.
     Moore,  et al.  (1977a) reported a very similar  study  in  which
 the interaction of PbB with  lead  in both  "first  flush"  water  and
 running water  was determined  (Moore,  et  al. 1977a).  The  study  was
 conducted in Glasgow,  Scotland,  where the water is extremely  soft.
 As  in  the Elwood study,  blood was drawn  from adult  females of  the
 household.
     The  Moore,  et  al. (1977a) study demonstrated that there is  a
 curvilinear  relationship between PbB  and  the  concentration of lead
 in  "first flush" water (Figure 2) .  The equation for the regression
 line was  x = 0.533 + 0.675 y,  with both values being expressed as
 umol/1.   Blood  lead  rose  as  the cube root  of "first flush" water.
 Actually, there  is an  error in  the equation.  The  term x  really is
 PbB and y is the cube root of the "first  flush"  water.  The authors
 point out that  the  lead  concentration  in  running water probably
 reflects  the impact  of drinking  water on  PbB  better  than "first
 flush" water.  They found  that the same relationship held, wherein
mean blood  lead rose  in  proportion  to  the cube  root  of running
water lead.  The correlation of running water lead to PbB was even
somewhat  better  than  that  of  "first  flush"  water to PbB  (r = 0.57
vs.  0.52). According  to the authors,  running water lead concentra-
tions were approximately one-third  the "first flush" lead concen-
trations.   These data are  useful in  that  they  provide  an  estimate
                              C-27

-------
    450
    400

Blood load
 (»1 »)


    ISO
     300
     250
     200
     ISO
        •  »'
TK< rtqrmion ef bleed Ited
on (merninq ) ««ttr lied in
Ce«rnoriir<
     100
               0 10    0 ZO   0 30    0 40    0 50    0 60    0 70    0 10    0 90     I 00
                                          W«l«r Itad (»»" )

             Rogrttsion o> blood-lead on morning watir lead in Caernarlonshir*.
                                       FIGURE  1

               Regression  of  Blood-lead on Morning  Water Lead
                                 in Caernarfonshire

                          Source:   Elwood,  et  al.  1976
                                          C-28

-------
          1,5 —
BLOOD LEAD
          0.5
Intervals  of
Uater Lead

No. of Samples
Interval
                                I
                .24 .48  1    1.44  2345

                                First Draw Water Lead  C/jmol/l)
                                FIGURE 2

             Mean Blood-lead Values  for Nine Grouos at
                 Intervals  of First-flush Water  Lead

                    Source:  Moore,  et al.  1977a
                                 C-29

-------
of the consequences of changing the concentration of lead  in water
from one value to another.  The example provided is the PbB conse-
quence of going  from  a  "first flush"  concentration of 0,,24 ymol/1
(50 yg/1) to 0.48 ymol/1  (100  yg/1).   Such a change results in an
incremental rise in PbB of 0.11 ymol/1, or of 2.3 yg/dl.  On a  run-
ning water basis, the PbB  change  would occur going from 24/3  or 8
yg/1 to 48/3 or 16 yg/1.  Using the authors' equation,  the effect on
PbB of lead in  running water  can  be  estimated (Table 5).   If  this
relationship is  correct,  the  impact  of water lead on  PbB is ex-
tremely great in the lower  ranges  of water  lead but diminishes  rap-
idly in the higher range of water lead  (50 to 100 yg/1).
     Hubermont, et al.  (1978)  also reports  the interaction  of morn-
ing  tap  water  lead  to PbB  in pregnant  women of  the household.
Again, as in the study of Moore, et al.  (1977a) a curvilinear rela-
tionship is described for the interaction of PbB with water lead:
         PbB = 9.62 + 1.74 log morning water Pb, (yg/1).
The correlation  was good  (r  = + 0.37; p = 0.001).   The calculated
impact of water Pb on PbB using this equation is considerably  less
in the lower range of water lead  than  in the Moore, et al. (1977a)
study.  The data may  not  be strictly  comoarable  concerning  water
sampling procedure.
     One additional  set  of data  is  available which  bears on the
question of  the  impact  of the  concentration of lead  in  water on
PbB.  A  study  was  conducted by the U.S.  EPA concerning the rela-
tionship of lead  in  drinking  water  to  PbB  (Greathouse  and Craun,
1976).  Both early morning and running water samples were  analyzed
for lead in a  soft  water  area  (Boston, Massachusetts) .   In  addi-
                               C-30

-------
                             TABLE 5




               Effect  of  Running Water  Lead  on  PbB*
Pb in Levels
(ymol/1) (y3)








0
0.
0.
0.
0.
0.
1.


0145
0725
1449
3623
7246
4493
ay
(y ) Pb Levels in
Running Water
(yg/D
0
1
5
10
25
50
100
_ (yg of Pb/1 of running
207
Total
PbB
11.03
14.44
16.86
18.37
20.99
23.58
26.84
water) -,

PbB due to
Water
0
3
5
7
9
12
15


.41
.83
.34
.96
.55
.81

*Source:  Moore, et al.  1977a
                            C-31

-------
tion, blood samples for members of the household were analyzed for



lead.  These subjects included both children and adults.  Numerous



variables that might  have  influenced  PbB were measured, including



age, sex, traffic density,  lead in dust, and socio-economic status.



The data  for interaction of PbB  and water Pb were re-evaluated by



Dr. Greathouse specifically for  the  purpose of  comparison  to the



analyses  of  Moore,  et al.  (1977a)  and Hubermont,  et  al.  (1978).



This was done subsequent to publication of the 1976 Greathouse and



Craun report.  Statistical analyses were performed using both the



Hubermont model (PbB = a + b  log Pb in  water)  and the  Moore model



(PbB = a  + b   Pb  water) .   These models  were  tested using (1) all



subjects aged 20  or more,  and  (2) women 20 to 50.  The models were



also tested using running water data and early morning water data.



Interestingly,  the relationship of early  morning water  Pb to run-



ning water Pb was  almost  identical  to  the  3:1 relationship reported



by Moore, et al.  (1977a).   More precisely, the relationship was:



     Early morning  water Pb =  -0.028 + 3.081  running water Pb



                      r2 =  0.235? p =  0.0001



     The  cube  root model of Moore, et al. (1977a) was more appro-



priate than the log water Pb model of  Hubermont,  et  al.  (1978) , and



the correlation of PbB with running water Pb was better than with



morning water  Pb.   The correspondence between data  from all sub-



jects  20  years of  age and over  and  for  women  age 20  to  50 was



striking:



     Females 20 to 50, n = 249
     PbB = 13.38 + 2.487  \} running water, Pb, yg/1



             p = 0.020










                               C-32

-------
     All subjects 20 yrs + , n = 390
             <	


     PbB = 14.33 + 2.541 3>/running water, Pb, yg/1



             p = 0.0065



     At this point it is useful to compare the data from the three



studies discussed above.   These  data  constitute the  sole firm foun-



dation for  assessinq  the impact of  lead  in  water on the  internal



dose of lead as  reflected  in  PbB.   The comparison is presented  in



Table 6.  Calculations are made as  to the PbB due to water over a



range of 1 to 100 yg Pb/1.  The comparison is made on the  basis of



running water Pb in spite of the fact that the equations  for the two



European studies were  developed on  the basis of  "first flush" or



"early morning"  water.   ^his  adjustment seems -justified since the



ratio of these values to running water values has been affirmed to



be 3:1 in  two  of the three studies  and  therefore probably is ap-



proximately correct for  the third study,  the one  by Hubermont, et



al. (1978).  It  is seen that the impact of lead in water on PbB is



quite different  among the three  studies.   Since  there is no basis



for rejecting any of the three studies, an estimate of the average



situation is made from an average of  the  three  sets of  data.   The



reasons for any variation in the relationships can only be left to



speculation. Certainly the calcium, phosphate, and iron concentra-



tions of the waters in  the three studies were different and may, to



some extent at least, account for the differences in the impact of



lead in water on PbB.



     It is  known that calcium  profoundly Depresses lead absorption,



even over a relatively  narrow range.   For example, Ziegler, et al.



(1978)  demonstrated  that a mere  doubling of the  dietary  calcium
                              C-33

-------
                                           TABLE 6

                                PbB Levels  due  to Water  Lead
PbB Due to Water (yq/dl)
Running Water
(yg/D
1
5
10
o
w 25
50
100
Greathouse and
Craun, 1976
2.54
4.35
5.47

7.43
9.36
11.79
Moore, et al.
1977a
3.41
5.82
7.34

9.96
12.55
15.81
Hubermont, et al.
1978
0.83
2.05
2.57

3.26
3.79
4.31
Average,
All 3 Studies
2.26
4.07
5.13

6.88
8.57
10.64
aThese values were all calculated using morning or  "first flush"  water  values  which were  taken
 to be three times the running water levels in the table.

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 level  profoundly  depressed  lead  absorption in infants.   Also,  ani-



 mal  studies have shown  that  nutritional  iron deficiency  enhances



 lead absorption.  Attention should  be  given to the  significance of



 the  variations in calcium  and  iron content  of  water against  the



 background  variations of calcium and iron  in nonaqueous portions of



 the diet.   As  with calcium, high phosphate levels also  tend  to  de-



 press  lead  absorption.



                              EFFECTS



     The  effects  of lead on  man will  be  reviewed  in a  selective



 fashion.  Greatest  emphasis will be placed on those  effects which



 occur  at  the lower levels of  exposure  and  those  which are  properly



 viewed with the most concern, namely neurobehavioral  effects, car-



 cinogenesis, mutagenesis, and teratogenesis.  Because of the  pauci-



 ty of  data  in  man and the seriousness  of the  effect,  some  sections



 will be  specifically subdivided into  sections dealing with human



 data and animal data.  In other  cases,  that does  not  seem necessary



 because of  the wealth of human data available.



     There is vast literature  concerning the effects  of  lead  on  the



 formation of hemoglobin and more limited literature on the related



 effects on  other  hemo-proteins.   From  the standpoint of  standard



 setting, the effects of  lead on  this system are particularly  impor-



 tant since current knowledge suggests that  the  hematopoietic  system



 is the "critical organ."  That  is  to say that effects are detect-



 able at  lower  levels of lead exposure than  is  the  case  with   any



other organ or  system.   The  mechanism whereby  lead reduces  the cir-



culating concentration of hemoglobin is not thoroughly understood.



Many specific  abnormalities exist,  some occurring  at  lower PbBs
                              C-35

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than others.   The  life span of erythrocytes is shortened  in  heavy



lead exposure  (PbB = 59 to 162)  (Hernberg,  et al.  1967).  The  mech-



anism  is  not well understood, but  damage  to the erythrocyte mem-



brane  is likely.  Dose-response and dose-effect relationships have



not been  established.   It seems  unlikely,  however, that shortened



cell life  results  in  lead-induced  reduction in circulating  hemo-



globin.  Rather, it is more likely that  the synthesis  of hemoglobin



is the critical mechanism.



     Although  there  is evidence  that lead interferes with globin



synthesis  as  well  as  heme  synthesis,  this  effect  seems  to  occur



only secondarily  to  a deficit in  heme  production  (Piddington and



White,  1974) .  Thus,  it is the action of  lead on  heme synthesis that



appears most critical.  This action is complex and  involves several



enzymes in the synthesis of heme  (Figure 3).



     Clear evidence exists that lead inhibits both d-aminolevulinic



acid dehydrase (ALAD)  and heme  synthetase both ir\ vitro and ir± vivo



at relatively  low  levels  of  lead  exposure.  Elevation of the con-



centration of  the  substrates  for  these  two  enzymes  in  plasma and



urine  (ALA) and in  erythrocytes (PROTO)  increases as PbB increases.



As a matter of fact,  rise  in PROTO and  ALA occur  at PbBs somewhat



below  those  associated with a decrement of  hemoglobin.   ^hus,  in



adults, a decrement in hemoglobin first  appears at PbB = 50 (Tola,



et  al.  1973)  and  at  PbB =  40  in  children  (Betts,  et  al.   1973;



Pueschel, et al. 1972), whereas a distinct elevation  in ALA in the



urine  (ALAU)  first  appears at PbB  = 40 in men (Selander and Cramer,



1970;   Haeger-Aronsen,  et al.  1974)  and children  (NAS,  1972) and



somewhat lower in women (Roels, et al. 1975) .  Rises in PROTO  first
                               C-36

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                         (Mitochondrion)
       Succinyl-CoA



          Glycme



  ALA Synthetase (ALAS)
         Heme
       s  Aminolevulinic

          Acid (ALA)
   Protoporphyrin IX
                         (Cytoplasm)
   ALA Dehydrase (ALAD)             CoprophyrinogenUI
Pb
      Porphobilinogen
-*- I Irnporphyrinogen TTT
                            FIGURE 3


             Effects of  Lead  on Heme Metabolism
                               :-37

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appear at PbB =  15  to  30  in women and children and at PbB = 25  in
men  (Sassa, et al. 1973; Roels, et al. 1975).  The most reasonable
explanation for the rise in PROTO at levels of lead exposure below
the threshold for hemoglobin decrement  is  that  the primary event  is
inhibition of  the insertion of iron into  PROTO  IX,  whether  it  is
caused by inhibition of heme synthetase or  by inhibited entry of  Fe
into  the  mitochondrion (Jandl, et al. 1959) .   Regardless of that
uncertainty, the effect is  the  same, a  potential decrement in hemo-
globin, which leads  to feedback  depression of  ALAS resulting in a
compensatory increase  in the production of ALA and other heme pre-
cursors.   The  evidence for this  compensatory  adjustment,  is  to  be
found  both  in  laboratory  animal  studies  (Strand,  et al.  1972;
Suketa, et  al.  1975)  and in studies of peoole with elevated lead
exposure  (Berk, et al.  1970; Meredith, et al. 1977).  The approxi-
mate  threshold  for  ALAD inhibition  is ^bB = 10 to  20  for  adults
(Tola, 1973)  and PbB  =  15  in  children   (Granick,  et al.  1973) .
Roughly equivalent  inhibition  occurs  concurrently  in the  liver  of
man  (Secchi, et al.  1974)  and in the liver and brain of rats (Mil-
lar, et al.  1970).  The toxicological  implications of ALAD inhibi-
tion have not been studied extensively.  However, substantial lead-
induced depression of  blood ALAD  activity in dogs  does not reduce
the blood-regenerating  response to acute hemorrhaging  in dogs (Max-
field, et. al.  1972).
     A few studies have been reported concerning effects of lead  on
hemoproteins other than hemoglobin.  Thus,  the  rate of cytochrome
P450-mediated drug metabolism has been  found to be depressed in two
cases of  lead poisoning (PbB =  60  and 72)  but not in 10 cases where
                               C-38

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lead exposure  ranged  from PbB = 20 to  50  (Alvares,  et al. 1975) .



Cytochrome content of  kidney  mitochondria has  also  been reported  to



be depressed in rats  (Rhyne and Goyer,  1971).



     The question arises  as  to  whether  certain peculations may  be



predisposed  to the toxic effects of  lead  as a  result  of G-6-PD



deficiency or  iron  deficiency.   G-6-PD deficiency is  known to  be



associated with increased susceptibility of  erythrocytes to  hemoly-



sis.  The possibility' of  increased susceptibility of G-6-PD-defi-



cient children  to  the hematopoietic  toxicity of lead has not been



reported.  In  regard  to possible  enhancement of  hemoglobin defi-



ciency  by  coexistent   iron deficiency,  the  one study  reported  to



date was  negative.    There  was no significant difference  in the



blood  hemoglobin  or  hematocrit among  29  iron-deficient  children



with PbB 20  yg/dl  as  compared  to  17  iron-deficient  children with



PbB = 20 to 40 yg/dl  (Angle,  et al. 1975).



     Dose-response relationships for the effect of lead on  various



parameters of  hematological  indices have been developed recently



(Zielhuis,  1975).   These are reproduced  in tabular  form  in  Table 7.



     In considering these data,  it is  obvious  that  PEP  (essentially



PROTO)   elevation  is a  more  sensitive correlate of  lead  exposure



than ALAU.   It  should  also be  noted,  however, that an  increase  in



PEP above normal also occurs  in iron deficiency anemia.  Thus, the



data must be  considered in that  light.   In a recent study  of PEP  in



lead-exposed  and non-lead-exposed  children,  Roels,  et  al.  (1978)



were able to  study the interaction of  PEP and  PbB in  the absence  of



anemia as indicated by  serum  iron  concentration.   They proposed  a



maximum acceptable  limit  for  PEP  at PbB =  25 ug/dl.   The maximum
                               C-39

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o
I
                                                 TABLE 7

                            Dose  Response  Relationships  for  the  Effect  of Lead

                             on Various Parameters of Hemotological Indices
       Percentage of adult female subjects
       with FEP levels that exceeded those
       found in control subjects with

            PbB = 20 yg/100 ml
Percentage of children with FEP
levels that exceeded those found
in control subjects with
     PbB= 20 yg/100 ml
PbB Level
(yg/100 ml)
11-20
21-30
31-40
41-50
51-60
61-70

No.
28
9
8

4

49
% with FEP Level
Higher than Normal
4
33
90

100


PbB Level
(yg/100 ml)
20
21-30
31-40
41-50
51-60
61-70

No.
87
72
24
14
12
10
219
% with FEP
Higher than
5
21
29

64


Level
Normal







       Percentage of  adult male subjects
       with  FEP  levels  that  exceeded those
             with PbB  =  20 yg/100 ml
Percentage of male adults with ALA-U
levels = 5 mg/1 and = 10 mg/1
     according to PbB level
PbB Level
(yg/100 ml)
11-20
21-30
31-40
41-50
51-60
61-70

No.
26
43
32
4
2
2
109
% with FEP Level
Higher than Normal
0
7
19

100


PbB Level
(yg/100 ml)
11-20
21-30
31-40
41-50
51-60
61-70

No.
17
27
36
55
38
34
207
ALA-U Level
= 5
0
0
14
33
74
88

(mg/1)
-10
0
0
j
11
37
50

        lSource:   Zielhuis,  1975

-------
 acceptable point was the mean FEP plus two  standard deviations  for
 rural children, which  equalled  79.2 yg  FEP/dl  erythrocytes.    The
 PbB  of  these children  was 9.1  ug/dl  +  0.5 with  serum iron  > 50
 yg/lOOml.  This maximum  is  very  similar  to the maximum acceptable
 FEP which would be calculated at mean FEP Plus two standard devia-
 tions (PbB = 26 ug/dl) cited  in  the  recent "Air  Quality for Lead"
 (U.S. EPA, 1977).   As was indicated earlier,  the cooperative effect
 of iron  deficiency  and lead exposure on FEP has not as yet been ade-
 quately  defined.   There is  lust the one  study  by Angle,  et  al.
 (1975),  suggesting  no  interaction at PbB = 20 to 40.
      The syndrome  of lead encephalopathy has been recognized since
 the time of Hippocrates as occurring in workers in the lead trades.
 The major features  were  dullness, irritability,  ataxia,  headaches,
 loss of  memory and  restlessness.   These  symptoms often  progressed
 to delirium,  mania, coma,  convulsions,  and even death.   The  same
 general  effects  were also described  in  infants  and  young children.
 Encephalopathy  due  to lead  was probably more frequently  fatal  in
 children than  in adults because lead exposure was usually  not sus-
 pected and because  children do not communicate signs and  symptoms
 as  readily as  adults.   The  mortality rate among children has been
 variously  reported  as being  from  5 to 40  percent.
     The  literature concerning the neurological  features  and the
probable  dose  of lead  involved is far  more specific for children
than for adults.    This  is  probably  because the problem persisted
longer and hence benefited more from the accumulated sophistication
of  disease  investigation.    Apart  from the  mortality  statistics,
there was a considerable toll recorded among survivors in the form
                              C-41

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of long-term neurological  sequelae.   Cortical atroohy,  convulsive



seizures, and mental retardation were commonly reported (Perlstein



and Attala, 1966; Byers and Lord, 1943).



     The minimal level of lead exposure resulting in lead encepha-



lopathy is not clearly known and perhaps never will be in light of



the dramatic decrease  in  the incidence of the disease, particularly



during the last 10  to  15 years.  Drawing mainly from his own experi-



ences, Chisolm (1968)  has estimated the minimal PbB associated with



encephalopathy  as  being  80 pg/dl.   There are  occasional reports



however  of  occurrence of  encephalopathy  at  PbBs  below  80  ug/dl



(Smith, et al. 1938; Gant,  1938).  Although 80 ug/dl may be a rea-



sonable estimate of threshold for  encephalopathy in  children, the



usual  values  are much  higher,  with  a  mean  of  approximately 328



according to one source  (NAS,  1972).



     It has been reasoned that if lead exposure as specified above



can  have  such severe  deleterious  effects  on  the  central nervous



system,  lower  levels  of  exposure might well result in more subtle



effects.   Specifically,  the  concern has  been over  whether  such



effects  occur  in children  whose PbBs are  in the 40 to  80  ug/dl



range.  Given  the  difficulties  of  study design,  it is hardly sur-



prising  that  all of  the relevant studies are  ooen  to criticism.



The most common deficiencies encountered are overlap of lead expo-



sure  in  the study  groups (Pb  versus  control), inadequate matching



for  socio-economic  status and other variable,  insensitivity of the



behavioral  tests,  and poor knowledge of  the degree  of lead exoo-



sure.  In  regard to this last-named problem,  the index of exposure



has  usually been PbBs determined at the time  of behavioral testing.
                               C-42

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 In  some  instances  record  of  one  earlier  Pb3  determination was
 available.   In  spite  of these problems, when  the various studies
 are  taken together,  subtle  neurobehavioral effects  do  appear to
 occur as a result of exposure  in  the  range of PbB  = 40 to 80 yg/dl.
      Two  general  approaches have been  used  in  attacking the prob-
 lem.  The most common  approach has been to evaluate two populations
 of  children  closely  matched  as  to  age,  sex,   and  socio-economic
 status,   but  differing  as  to lead  exposure.    These studies  are
 retrospective and usually  strictly  cross-sectional.   In  only one
 instance was  a follow-up repeat  study of the population  performed
 (de la Burde  and Choate, 1972, 1975).  The  other  general  approach
 has been to identify children  with neurobehavioral deficits of un-
 known etiology and  to establish whether  their lead  exposure  was
 excessive in  comparison  to appropriate control  children.    Aside
 from the  usual  specific flaws in experimental design,  there  has
 been the additional  question as to which came first,  the excessive
 lead exposure or  the neurobehavioral  deficit.   Among  mentally  sub-
 normal children whose problems  were clearly attributable  to  etiolo-
 gies other than  lead,  pica  incidence and  PbBs  were  both elevated
 (Bicknell,  et al.'1968) .
     Among  studies of the  first  type,  those  of  de  la  Burde  and
 Choate (1975)  are  illustrative of the problems  that exist  in  this
 area of  toxicology.  Fine motor dysfunction,  impaired concept  for-
mation, and altered behavior profile  were observed in 70 preschool
children exhibiting pica and elevated PbBs,  all of which were > 30
yg/dl.  The mean  level  was 59 yg/dl.  The children were examined at
four years and again  at seven vears of age.   Both the lead-exposed
                              C-43

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group and the control group had been followed from infancy through
eight years  of  age  as part of  a Collaborative Study  of Cerebral
Palsy, Mental Retardation, and Neurologic Disorders of Infancy and
Childhood.   Unfortunately,  the  control  group did not  have blood
lead analyses performed.   However,  tooth  lead  and urinary coprooor-
phyrin determinations were ultimately  performed.   Another problem
was  the  inference  that positive radiographic  findings  of lead in
long bones and/or  intestines  were  found  in subjects  with PbBs in
the  range of 30 to 40 ug/dl.   Lead lines in bones at this level of
exposure  are  extremely unlikely (Betts,  et  al.  1973), suggesting
either that  the blood lead determinations  were  spuriously low or
that they had actually been higher at  times which did not coincide
with the time of sampling. Thus, it would seem that the minimal PbB
associated with neurobehavioral  effects may well have been more on
the  order of  50 to  60 ug/dl  rather than  30 to 40 ug/dl.  Overall,
the  experimental design was otherwise  generally sound.
     Another  often-cited  study  by Perino and Ernhart  (1974) was
basically of  the same general design as  the one reported by  de la
Burde  and Choate (1972,  1975).  It concluded that neurobehavioral
deficits  occurred  at PbBs as  low  as 40  yg/dl.   The  flaw in  this
study was that  the parents in the control group were better  educat-
ed  than  those of the  lead-exposed  children.   Differences  found may
have been due to the fact that  more highly educated parents  train
their  children more  on  tasks related to  the behavioral measures
used.   Low  lead parent-child intelligence was correlated  at 0.52
and high  lead at only 0.1.  The low correlation in high lead groups
suggests that a factor other  than  parental influence  was operating
and probably was lead exposure.
                               C-44

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      Albert, et al. (1974)  studied school-age children with a his-
 tory of PbBs  ) 60  ug/dl  early in childhood.   Unfortunately,  PbBs
 for about  one half  of  the control population were not available and
 some of the control children previously had PbBs ^40 yg/dl.
      The same types of flaws existed in studies which came up with
 negative results.   Thus,  Kotok's study  (1972)  had a  rather  wide
 overlap between PbBs of control subjects and lead-exposed subjects,
 and in  another  negative study fewer than half of the "lead-exposed"
 group had  PbBs  _>_40  yg/dl  (Lansdown, et al. 1974).  Another problem
 among negative  studies has  been the  study  of  perhaps inappropriate
 populations.   Lansdown's population consisted  of British  children
 living  in  the vicinity of  a  smelter.   In another  negative  study,
 the children were Mexican-Americans  also  living in  the  vicinitv  of
 a  smelter   (McNeil,   et  al.  1975) .   The problem population we are
 dealing with in  this  country is of  an entirely different  socio-
 economic  character;  inner  city  children  who  are  predominantly
 socially and economically deprived.   The difference  in  background
 may be  significant  as  a determinant of  behavioral ability.
      In summary, there  is sufficient  evidence to indicate  that
 subtle  neurobehavioral  effects  of  lead  exposure occur in children
 exposed to  lead  at  levels which do not  result in clinical encepha-
 lopathy.  The minimal level  of lead exposure,  the duration of expo-
 sure  required,  and   the period  of greatest sensitivity  cannot be
 specified with  any  degree of  certainty.   However,  the conclusions
of  two  recent expert groups who have evaluated the literature in
great depth are remarkably similar.   The World Health Organization
concluded  that   the  probability of  noticeable  brain  dysfunction

-------
increases in  children  from PbB  levels  of approximately  50  ua/dl
(WHO,  1977), and the U.S. EPA Science Advisory  Board  concurred in
the U.S.  EPA conclusion that  "the blood  lead levels associated with
neurobehavioral deficits in asymptomatic children  appear  to  be in
excess of 50  to  60  yg/dl."   Future research  may  reveal that this
cut-off point is actually lower.   Effects  of  lead exposure on the
peripheral  nervous  system of  both adults  and  children  are also
documented.   A number of studies have documented the occurrence of
slowed nerve conduction with  an  approximate ^bB  maximum  of  50 ug/dl
(Hernberg,  et al.  1967;  Lilis,  et al.  1977;  Landrigan  and Baker,
1976).  This effect has been noted to occur at  this exoosure level
without any overt signs of neuromuscular impairment.
     Although generally considered not  to be  a  maior public health
problem today, the potential damage to  the brain of the fetus  from
lead  exposure has received some  attention.  Beattie, et al.  (1975)
identified  77 retarded children  and 77  normal children matched for
age,  sex, and geography.   Of 64 matched pairs,  11 of the  retarded
children  came from homes in which  the concentration of  lead  in the
"first  flush"  water exceeded 800  ug/1.   By contrast,  none of the
control children came  from such  homes.   In  a  follow-up  study,  PbBs
from  the  mental retardates,  taken during the second week  of  life,
were  found  to be significantly  higher  than  those of control  sub-
jects (25.5 yg/dl  versus 20.9 ug/dl)  (Moore,  et al.  1977b).   Taken
at face  value,  those  studies  are extremely provocative.   They sug-
gest  that the brain  of the fetus is  considerably  more  sensitive  to
the toxic  effects of  lead  than the  brain  of the infant  or  young
child.    Lambs  exposed to low  levels  of lead  in  utero (PbB = 35)
                               C-46

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 developed impaired  visual  discrimination learning  behavior  (Car-
 son,  et al.  1974).   In spite of  this  seemingly low level of  expo-
 sure,  control  animals  were  exposed  ir\  utero to  lower levels of lead
 (PbB  = 5)  than are  generally  considered normal  for most species.
 Bull  and  coworkers  have exposed  female rats  to Pb from  14  days
 prior  to breeding through  weaning  of  pups.   The  normal  postnatal
 increase in  cerebral cytochromes  (Bull,  et al.  1978)  and synapto-
 genesis in the cerebral cortex (McCauley, et al. 1979)  were delayed
 by  this treatment.   These delays were associated with delays in the
 development  of  exploratory  and locomotor behavior during  the  same
 development  period   (Crofton,  et al. 1978).  The  latter effect  was
 shown  to be  entirely due to exposure  to Pb  _in utero.   Blood  lead
 concentrations  on  the  18th day of  gestation  were reported to  be
 31.9 yg/dl.  Further work is urgently  needed concerning the neuro-
 behavioral effects of  low-level lead exposure _in  utero.
     Final.ly, a few comments are  in  order regarding neurobehavioral
 effects  of low-level exposure  in  adults.  A battery of performance
 tests were administered  to  190  lead-exposed  workers,  along with  a
 questionnaire  (Morgan  and Repko,  1974).   PbBs were below 80 ug/dl
 in many  of the  workers.  Unfortunately,  there  were many methodo-
 logical problems and equipment failures  which rendered the  results
 difficult  to  interpret.   Further,  results  of   a  similar  study by
other  investigators  were  essentially  negative  (Milburn,  et  al.
1976).   Thus, although  it seems reasonable  to  suppose  that neuro-
behavioral effects do  occur at  some level of  exposure  in workers,
 it is extremely difficult to  specify the exposure  level  at which
these effects may occur.
                              C-47

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Carcinogenicity
     Three groups  of  investigators have  reported epi^emiological
studies of causes  of  death among  people  overly  exposed  to lead.
The first  such  study  was of causes of  death  among 184 pensioners
who died between 1926  and 1961 and  of 183 men who died between 1946
and 1961  while  still  employed  (Dingwall-Fordyce  and  Lane, 1963) .
The men were  categorized as to lead exposure based  on the nature of
their work and, in the case of highly exposed men, on the basis of
urinary lead excretion  (100 to  250 yg/dl  during the past 20 years
and probably higher than that earlier in the work  historv).  There
is a correlation between  urinary lead and  blood lead,  wherein 100
yg Pb/1 in urine corresponds roughly  to  50  ug/dl in blood  (Selander
and Cramer, 1970).
     There were  179 men  in  the high exposure  category for which
causes of death were registered, 67 men  in  the category  of negligi-
ble exposure and 91 men  with no  exposure.  Although there was a sig-
nificant excess number of deaths among the  men who had been  exposed
                                                    *
to the greatest lead hazard, this excess could not be attributed  to
malignant  neoplasms,  as  the  mortality  rate  from  this  cause was
actually  somewhat  less  than expected.   Furthermore, the  incidence
of death  from  malignant neoplasms  in this group has  actually in-
creased  in the more  recent years  as working  conditions have im-
proved.   It  seems,  rather, that the  excess deaths  in the  heavily-
exposed  group  was  due  mainly  to  vascular lesions of  the  central
nervous system among men employed in  the lead  industries; during the
first  auarter of this century.
                               C-48

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      The  second  relevant  study was of orchardists who at one  time
 sprayed fruit trees with lead arsenate.   A cross-sectional study of
 this population  was conducted  in  1938  by  the  U.S.  Public Health
 Service (Nelson,  et al.  1973) .   The population was classified as to
 exposure  on  the  basis of  whether  they were adult orchard workers,
 (orchardists and lesser-exposed  "intermediates"  as  separate cate-
 gories) , non-exposed adults of the area, and children in the area.
 For all categories blood  lead,  urine  lead,  and  arsenic concentra-
 tions were determined.  In addition,  the number  of  years of spray
 exposure  was  recorded  for  the  orchardists and  "intermediates."
 There was a definite gradation  in  blood and urine lead concentra-
 tion corresponding  to  the  degree  of  exposure  as  classified  by
 nature  of orchard-related work  or  lack  thereof.  The  orchardists
 had the highest PbB (x = 44 for  males and  43  for females) .   Children
 of  the  area were  intermediate (PbB = 37 in boys and 36 in girls)  and
 adult consumers and  "intermediates" had  PbBs of  22 to  30.
      In 1968  a follow-up study of  this population was  begun.   Re-
 sults were reported in 1973 (Nelson, et al.  1973). Of  the original
 1,229 study members, the status of 1,175 could be determined.  Four
 hundred  and  fifty-two  had  died  and death certificates were avail-
 able  for  442.    No  consistent  differences  in  Standard  Mortality
 Ratios  (SMR) were observed on the basis of either  exposure classi-
 fication or duration of  exposure.   The only  deviations  in SMR from
 expected were in  the direction of fewer-than-expected deaths.  The
mortality  records for heart disease, cancer, and  stroke were exam-
 ined separately.  Again,  there was no suggestion of a relationship
between  lead  exposure and death  from any  of  these  three  maior
causes of death.
                              C-49

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     The most  recent  study of causes  of  death among lead-exposed



workers was reported by Cooper and Gaffey  (1975) and Cooper (1976) .



Since the results were published,  the  study population has been re-



examined (Cooper, 1978).   Results  from the updated  study  will be



discussed,   although  details  as  to lead  exposure  history  appear



mainly in the earlier  publication.   The objective of the study was



to determine  what happened to  lead  workers whose  levels  of lead



absorption  were  below those associated  with  clinically-recogniz-



able illness but above that of the general population.  The popula-



tion studied consisted of  2,352 smelter workers  and 4,580  battery



workers.  Death certificates were available  for 1,703 of these men.



A good  record  of  lead exposure  history was considered  important.



Unfortunately  biological  monitoring  programs   (lead  in urine or



blood)  were not in effect in many of  the plants  during the period of



employment, particularly so for  the deceased.   Nevertheless, enough



data were available to indicate  that exposure  was heavy.  Thus, 67



percent  of  1,863  workers  had PbBs  ^ 40  yg/dl and  20  percent had



PbBs  y 70  yg/dl.   Twenty-six  percent  of  the   battery  workers and



21.1 percent of the smelter workers had been employed for more than



20 years.



     The only causes of  death  that showed a statistically signifi-



cant elevation were "all malignant neoplasms"   in the battery work-



ers, cancers  of  "other  sites"  in  battery workers  and  "symptoms,



senility, and ill-defined conditions"   in battery workers.  In only



one of all the cancer  deaths was  a renal tumor  specified.  Only two



tumors  of  the  brain were  identified  in the follow-up  study.   (No



specification  is  made  in  the original  1975   report as to  brain
                               C-50

-------
 tumors.) The  author  of the 1978  report  concludes that the excess
 deaths due  to  neoplasms cannot  be  attributed to lead "because there
 was  no consistent  association  between  the  incidence of  cancer
 deaths and either  length  of  employment or estimated  exposures to
 lead."  It  is  not clear from reading either of the two reports con-
 cerning this  population as to  just  how exposure categories  were
 established.
      In a  letter to Science,  Kang,  et al.  (1980)  questioned  the
 appropriateness of basing  the  decision of statistical  significance
 of the results on confidence limits rather than on calculations of
 a  more rigorous statistical test.  In  their reanalysis  of  the  re-
 sults of the 1975 report by Cooper and Gaffey,  Kang,  et al.  (1980)
 used  the test  statistic z  = - SMR -  100   _  and  calculated  a  sfca_
                             100  -/I/expected
 tistically  significant  increase  in deaths due to all malignant neo-
 plasms,  cancer  of  the digestive  organs,  and  cancer  of  the  respira-
 tory  system for lead smelter  workers.   For battery plant  workers
 they  calculated a  statistically  significant increase  in cancer  of
 the digestive  organs and cancer  of  the respiratory system.   They
 did not calculate an increased  incidence of  all  malignant neoplasms
 for these workers.  Based on their calculations,  the authors  state
 "observation of  a  significant  excess  of cancer  in  two  independent
 populations  exposed  to  lead in  two  different  industrial settings
 lends  credibility  to the suggestion  that lead  is  an  etiological
 factor. "
     In  their responses  to  Kang,  et  al. (1980), Cooper (1980) and
Gaffey (1980) support the methods  and  conclusions  of their previous
work.
                              C-51

-------
     In  1953  a  study  was published  indicating that  lead causes
renal  tumors  in  rats  (Zollinger,  1953).   Since that  time,  five
other  studies  have  confirmed this finding  (Boyland,  et al. 1962;
Van Esch,  et  al. 1962;  Roe, et al.  1965;  Mao  and  Molnar, 1967;
Oyasu, et al.  1970).   The  same  observation  has also been  reported
in mice but could not be elicited in hamsters  (Van Esch and Kroes,
1969) .  Other  studies indicate that  lead  also  causes  lung tumors  in
hamsters (Kobayshi and Okamoto, 1974)  and cerebral gliomas  in rats
(Oyasu,  et  al.  1970).   All  of  these  studies  were  conducted using
levels of lead exposure far in excess  of  tolerable human doses, but
most were designed to study  the mechanism of  lead-induced  carcino-
genesis.
     The  first  report  of lead-induced  renal  tumors  (Zollinger,
1953)  was essentially a lifetime study in rats, with administration
of  lead  beginning  at 150  to  180 grams  body weight and continuing
for up to 9.5 months.  Single weekly doses of  20 mg lead phosphate
were administered subcutaneously.  Of the 112  animals on lead that
were  examined,  many  died early in  the study.    Twenty-one  had
tumors.   Of  the 29  animals  remaining  after  10  months,  19  had
tumors.  The last animals  were  killed 16.5 months after initiation
of  the lead injections.  All  the tumors were renal  and were classi-
fied as  adenomas, cystadenomas, or papillary  adenomas.  Metastases
were evident in  only one case.  According to  the histological cri-
teria  for renal toxicity, all the animals receiving  lead had severe
lead   intoxication.     Among   50  control  animals,   none  developed
tumors.
                               C-52

-------
      The next  study reported  (Boyland,  et  al.  1962)  tested  the



 hypothesis  that  renal cancer due to lead was actually caused by the



 well-known  accumulation of porphyrins associated with lead toxici-



 ty.  To  test the hypothesis, elevated porphyrin excretion was stim-



 ulated  by administration of allyl-isopropylacetamide  (AIA)  in  the



 diet of  20 rats for one  year.  A like number of rats were fed 1 per-



 cent  lead acetate  in their diet  for  one  year.   Both groups of ani-



 mals  were observed until  they became  ill  or had palpable tumors.



 During  the  period  of lead  administration  the mortality rate in  the



 two groups  was quite similar.  Subsequently  the lead-fed rats died



 earlier  than the AIA rats.  Subsequent to the 1-year administration



 of test  compounds all but one of  the lead-fed rats had renal tumors



 whereas  none  of  the AIA group had  tumors  of any kind.   It  is  not



 clear whether the accelerated mortality among the lead-fed rats  was



 due to  the  tumors or  to  other toxic effects  of  lead.



     Van  Esch,  et  al.  (1962) presented  the  first  study  in  which



 tumor mortality  was determined  at  more than  one dosage  level of



 lead.  In this case lead was administered  in  the diet  as  basic lead



 acetate,  0.1  percent in one  group  and 1.0  percent in the  other.



 Approximately equal  numbers of males  and  females were used.  Each



 lead-fed group was compared to its own set  of controls, not receiv-



 ing lead.   Prior to  the  termination  of the experiment, only mori-



 bund animals were killed and examined morphologically.  At equiva-



 lent durations of lead administration, using these guidelines  for



 tumor assessment,  the higher dose  of lead  was more carcinogenic



 than the lower  dose.   Thus,  at the end of 600 days of lead adminis-



tration, 31  percent of the animals  which survived to 400 days died
                              C-53

-------
from renal  tumors  in the 1.0 percent  lead  acetate group, whereas



only 14 percent of  the  animals alive at 400 days in the 0.1 percent



lead acetate  group died of renal tumors  (Figure  4) .   Mortalities



with tumors in the subsequent 200-day period (600 to 800) were not



comparable  because  in  the case  of the 1.0  percent lead group all



the animals were killed at 730 days, whereas  in the case of the 0.1



percent lead  group the animals were allowed  to  survive until 985



days unless they became moribund.  It  should also be noted  (Table



8) that during the  first 600 days of the 0.1  percent basic  lead ace-



tate regimen,  10 of the original  26 rats  (38 percent)  died without



renal tumors  as compared  to one  of the original  26 in the control



group  (4 percent),  indicating that at  this  level  the lead regimen



was lethal  in some manner unrelated  to its  carcinogenicity.   As a



matter of fact, both levels of lead  administration caused reduced



body weight gains,  suggesting toxicity  unrelated to carcinogenesis.



     The next study of lead-induced tumors  in rats  was  also de-



signed to shed light on the mechanism of  lead carcinogenesis  rather



than  to  define dose-response relationships.   Roe,  et  al.  (1965)



sought  to  establish  whether testosterone  or  xanthopterin  would



influence  the induction of renal neoplasms  by lead  in  rats.   In



this study, the forms of lead,  lead orthophosphate, and  the mode of



administration were unique.  The lead  salt was administered  subcu-



taneously  once weekly  for four  weeks,  then intraperitoneally for



nine weeks; then after  a rest period of four  or nine weeks, depend-



ing on the particular   group of  rats,  lead  administration was re-



sumed  for an  additional 14 weeks.  All  the animals were  males.  The



dosage schedule of  lead is presented in Table  9,  assuming  an aver-
                               C-54

-------
                  100 j  I
Cumulative %
Mortality  (O )
or % Animals c
Tumors  at  Time
of Death  (©)
                  90
                  80
70
                  60
                   50
                  40
                  30
                  20
                  10
          i      r
                     ~  Total n = 29
                             0.1% PbAc
                        Total n = 26
                          1.0% PbAc
                                                            JL
                       0    201  401   601   0   201   401   601
                       4,     4,    >    4.    4-    ^    4-     4-
                      200    400  600   729  200  400   600   730
                                TIME  INTERVALS,DAYS
                            FIGURE 4

       Cumulative  Mortality and  Tumor Incidence  in Rats

                 Source:  Van Esch,  et al. 1962
                            C-55

-------
                                                                   TABLE 8

                                      liffect  of  Lead  Exposure  on the Incidence of Renal Tumors in Rats
O
I
cn
"n  at beginning of interval-
   dead,  no renal tumors
   dead,  renal tumors

 n  at beginning of interval-
   dead,  no renal tumors
   dead,  renal tumors
              n  at  beginning of interval-
                dead,  no renal tumors
                dead,  renal tumors

              n  at  beginning of interva.1-
                dead,  no renal tumors
                dead,  renal tumors
Successive Time
0-200
Cb
15
2
0
14
0
0
0.1C
16
0
0
16
0
0
201-400
C
13
1
0
34
2
0
0.1
16
1
0
16
1
0
401-600
C
12
2
0
12
3
0
0.1
15
1
0
15
6
1
Intervals, Days
601-729
C
10
3
0
9
4
0
0.1
14
1
3
9
4
0
601-800 800-985
C
10
5
0
9
6
0
0.1 C 0.1
1456
651
305
935
331
004

C
13
0
0
13
0
0
1.0d
11
1
0
13
4
0
C
13
0
0
13
0
0
1.0
10
1
2
9
2
1
C
12
1
0
13
0
0
1.0
7
1
1
6
1
3
C
13
0
0
13
0
0
1.0
5
1
2
2
0
2
C
13
12
0
13
13
0
1.0
5
1
4
2
0
2
              ^Source:   Van Esch,  et al.  1962

              hC = Control
              C0.1 = 0.1% basic lead acetate in diet

              (11.0 = 1% basic lead acetate in diet

              "n = number

-------
                                     TABLE 9
  Dosage Schedule used by Roe, et al. (1965) in their study of the Influence of
Testosterone and Xanthopterin on the Induction of Renal Neoplasms by Lead  in Rats



o
1
U\
-O





Group
Pb alone
Pb alone
Pb alone
Pb + testosterone
Pb + xanthopterin
Pb + testosterone
Pb + xanthopterin
Xanthopterin
Testosterone
No treatment
Pb,
mg/kg/d
2.63
1.25
0.17
1.25
1.25
0.17
0.17
-
-
-
Days on Pb
242
238
238
238
238
238
238
238
238
238
n*
24
24
24
16
16
16
16
16
24
24
  *n = number

-------
age  body weight of  400  g,  and averaging  the  dose over the  total
treatment period.
     In  analyzing  the cancer  data for these groups,  it  seems  rea-
sonable  to  pool all the groups receiving  the  same dosage of  lead
since  neither  testosterone nor xanthopterin  influenced the  tumor
incidence.  However, xanthopterin  alone  seemed  to  increase  the  mor-
tality  rate whereas testosterone alone  did  not.   Therefore,  only
the  lead  alone,  the lead plus testosterone, and  the no treatment
and  testosterone  alone groups are pooled  here at equivalent  lead
dosages.  The results are summarized  in Table 10.
     It  is  not  possible  to establish the slope of the  interaction
between dosage of  lead and  tumor  incidence.   The highest dose was
so toxic  that there  were only two survivors  by the time the first
tumor appeared in that group  (Table 10).  The remaining  two dosage
levels, by contrast, did  not cause death  unrelated to  tumorigenesis
(Figure 5). However,  since  only one  of  these  two remaining dosage
levels was  tumorigenic, no dose-response relationship in regard to
tumorigenesis is calculable.
     Interstitial nephritis occurred  in all groups, including  con-
trols.    Unfortunately,  other manifestations  of  toxicity,  e.g.,
anemia, reduced body weight gains, and  food  consumption were not
reported.   In  keeping with the observations  of Van  Esch,  et al.
(1962), Boyland,  et al.  (1962),  Mao and Molnar  (1967), and  Zol-
linger  (1953),  very few of  the affected animals exhibited metasta-
sis and no elevated incidence  of other types of tumors was noted.
     Neither of the  two remaining  reports  concerning the carcino-
genic effects of lead in rats  (Mao and Molnar,  1967; Oyasu, et al.
                              C-58

-------
                                                                            TABLE 10
                                          Summary of Mortality Data Resulting Irom Lead Phosphate Administration to Rats
                                                                  Successive Time Intervals, Days


o
I
01
l£>









0-100 101-200 201-300 301-100 101-500 501-600 601-700
Cb 2.6C I.3C .I7C C 2.6 1.3 .17 C 2.6 1.3 .17 C 2.6 1.3 .17 C 2.6 1.3 .17 C 2.6 1.3 .17 C 2.6 1.3 .17
n at beginning ^ 2() w <,0 ^ 6 37 w M 3 37 38 <,6 2 37 31 11 1 35 25 26 - 11 18 11 - 6
of interval
dead, no renal o 18 3 003022 1012019 15 077 15- 5 16 II 01
Illinois
dead, renal 00 0 000000 0000110 111101- 300 5
Illinois.
dyin^wlill 00 0 000000 0000 50 30 2 100 10 01- 57 00- 83
turiloi i
mol'lllii'ty? 0 82 18 00 95 18 5 1 100 18 15 9 100 21 37.5 11 100 65 55 71 100 91 95 IOO IOO IOO IOO
no tumors
nlortaul'y? 00 0 000000 0000130 21 35 0 1 - 15 01 - 58
luinorb
' Soiuxo: Uoe, et ul. 1965
 (" - i ontrolb
 A VIM age dose ol lead pliosphate, ing/kg/day

-------
 %
DEAD
           100
            90
           80
            70
           60
           50
           40
           30
           20
           10
 0
 i>
100
                      0
                      '2.6
                                         Control
                                                _L
101
 b
200
201
 -i,
300
301
 -4-
400
401
 4,
500
501
 .1, .
600
                                                601
                                                 J/
                                                700
                                TIME INTERVALS,  DAYS
                          FIGURE 5

             Cumulative Mortality Among Rats
                  not having Renal Tumors

                 Source:  Roe,  et  al. 1965
                            C-60

-------
1970)  involved  more than  one  level of  lead  administration.   The
results obtained  by Mao  and  Molnar  (1967)  serve to  confirm the
results of Van Esch, et  al.  (1962) in that both groups used  the same
regimen of lead in  the diet (1 percent lead acetate)  and got simi-
lar  incidences of  renal  tumors  [50  percent by Van Esch  (1962) vs.
77.5 percent by Mao and  Molnar  (1967)].   Both also noted  that the
first appearance of tumors was at about 300 days following initia-
tion of lead  administration.   Mao and Molnar  (1967)  are the only
authors who  conducted any  lead  analyses.  They  reported  19.3 to
54.2 yg Pb/g kidney cortex  as compared  to 3.1 yg Pb/g in  a single
normal specimen.  By way of comparison  to man,  Barry  (1975) report-
ed  a mean of  0.66 yg/g  in kidney  cortex of  10  occupationally-
exposed adult males, with a standard deviation of + 0.56 uq/g.
     Oyasu, et al.  (1970)  used a  dietary  regimen of lead  subacetate
for  326 to  432  days,  either alone or combined with  indole in one
case and acetylaminofluorene (AAF) in the other.  Neither  of these
substances alone caused  renal  tumors.  Therefore,  the  data  for lead
with and  without  these  additional  substances could  be  combined.
Fifty-nine percent of 130 animals receiving 1  percent  lead  sub-ace-
tate in the diet eventually developed  renal tumors.   This report,
incidentally, is the only one in which oral feeding of lead was to
cause tumors other  than  renal.   Eight  percent of the 130  lead-fed
rats developed gliomas.    All but one of  these were cerebral.  One
was cerebellar.  The incidence of gliomas in animals receiving AAF
alone was 2.5 percent, compared  to 0.3 percent in controls.  There
did  not seem  to be any  synergistic  effect between AAF  and  lead.
Lead did not cause any other types of tumors.   The toxic  effects of
lead in this study, apart from carcinogenesis, were not  reported.

                              C-61

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      Van Esch and Kroes (1969) have reported  that  basic  lead ace-
 tate  causes  renal  tumors  in  mice,  but  not  in  hamsters.  These were
 lifetime studies with  lead being  incorporated into  the  diet begin-
 ning  at  five  weeks of  age  for the mice and three to  four  weeks  of
 age for  the hamsters.  Two levels  of lead were used,  0.1  percent and
 1 percent, cut back to 0.5 percent early in the study owing to tox-
 icity.   Only one renal tumor  was  found at the high  level  of lead
 intake in the mice, but this  was probably  because most  of  the mice
 died  within  the first 100 days of lead administration.   Fourteen
 percent of the mice receiving 0.1  percent basic lead acetate devel-
 oped  renal  tumors.   There  were  no  renal tumors  in hamsters  at
 either dosage level of  lead.   Mortality was somewhat increased  at
 both  levels of lead administration.
      Another  report of  experimental  carcinogenesis  is a report  of
 induction of  lung  tumors  in  Syrian hamsters  using  intratracheal
 injection of  lead  oxide  (Kobayachi and Okamoto, 1974) .   Actually,
 tumors were  produced  only when  benzo(a)pyrene  (BP)  was   injected
 simultaneously  with  lead  oxide.   Neither compound  alone  caused
 tumor formation under the conditions  described.   This cooperative
 effect was obtained  using 10  weekly  injections.  The tumors  were
predominantly adenomas  of bronchio-alveolar origin.   In addition  to
 this  effect,  both  lead  alone  and  in combination with BP  caused a
very high incidence of alveolar metaplasia,  which the  authors  spec-
ulate may be  a  preneoplastic change.    BP  alone  caused  a  very low
 incidence of  alveolar  metaplasia.   All  treatments, including the
methylcellulose injection vehicle alone caused some  deaths.
                              C-62

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      The  final study concerning the carcinogenic effects of lead is
 the most  significant of all (Azar, et al. 1973).  It confirms other
 studies showing that lead causes renal tumors in rats and that male
 animals are  more  susceptible  than females.  A  dose-related  effect
 is  clearly evident (Table  11)  (Figure 6) .  The  dose of  lead  re-
 quired to produce tumors  did  not clearly result in  increased  mor-
 tality  among the  animals;  however,  at  dietary lead intake  above
 1,000 ppm, weight gains were  reduced.
      In  summary,  there is  little doubt  that  certain compound  of
 lead  are  carcinogenic  or  at least co-carcinogenic in some species
 of experimental animals.
 Teratogenicity
     There is little information  in the  literature  to suggest  that
 lead has a teratogenic effect  in man.   Although  there were  numerous
 reports of a high incidence of stillbirths and miscarriages among
 women working  in  the  lead  trades,  fetal anomalies were  not de-
 scribed.  It must  also be pointed out  that these women were Droba-
 bly exposed  to much higher concentrations of lead than for occupa-
 tionally  exposed  men  today.   Recent  literature  is  devoid of any
 references to teratogenic effects of lead  in man.
     In experimental  animals,  on the other  hand,   lead  has been
 shown repeatedly to have teratogenic effects.  Early  studies demon-
 strated this  in  chick  embryos by injection of  lead into the yolk
 sac (Catzione and Gray, 1941;  Karnofsky and Ridgway, 1952).  Tera-
 togenesis has also been  observed in rodents.   These studies were
done using high doses of lead given intravenously or  intraperitone-
ally.   For example,  McClain and Becker  (1975)  used single intra-
                              C-63

-------
                                             TABLE  11
                              Mortality and Kidney Tumors in Rats Fed
                                    Lead Acetate for Two Years*
o
i
Dietary Pba
(ppm)
5
18
62
141
548
3
1,130
2,102
No. of Rats
of Each Sex
100
50
50
50
50
20
20
20
% Mortality

Male
37
36
36
36
52
50
50
80

Female
34
30
28
28
36
35
50
35
% Kidney Tumors

Male
0
0
0
0
10
0
50
80

Female
0
0
0
0
0
0
0
35
       *Source:  Azar, et al. 1973
       aMeasured concentration of Pb in diet
        Includes rats that died or were sacrificed in extremis

-------
            99
            90

            80

 Percent
 animals
with renal  50
  tumors
            10
                                                                     99
                                              90

                                              80




                                              50
                                              10
             10.1
0.2
0.5
                                                                     10
                       ppm Dietary Pb x IT
                             FIGURE 6

             Probit Plot of Incidence of Renal Tumors
                           in Male Rats

                    Source:  Azar, et al. 1973
                               C-65

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peritoneal doses of 25 to 70 mq/kg  in rats.  They found that  terato-
logic effects occurred when administration was on day  9.  Adminis-
tration  later  in pregnancy resulted  in  embryotoxicity  (fetal  re-
sorption)  but  not  in teratogenic  effects.    Carpenter  and Perm
(1977)  observed  teratologic   effects  in  hamsters  following  the
administration of 50 mg/kg Pb(N03)2 intravenously on  day 8.   Chron-
ic administration of lead in the drinking water  of pregnant  rats at
very high concentrations  (up to 250 mg/1)  resulted in delayed fetal
development and fetal resorption without teratologic effects (Kim-
mel, et al. 1976).
     In  summary,  it  seems  that,  in man,  embryotoxicity precedes
teratogenicity in the lead sensitivity  scale.  This is  supported  by
historical experience in  occupationally exposed  women and by animal
studies.
Mutagenicity
     Pertinent data  could  not  be located in  the available  litera-
ture concerning the mutagenicity of lead.
Reproductive Effects
     As was indicated in the previous section, lead has been  known
to cause miscarriages and stillbirths in women working  in the lead
trades during the latter  half  of the  19th century and probably  on
into the early part of the 20th  century.   It  is very difficult  to
estimate minimally  toxic  exposure  for  stillbirth and miscarriages
because exposure data, e.g., PbB are lacking for women who experi-
enced this  problem.   The minimally toxic  level of  exposure may
actually be quite low.  Lane  (1949) reported  on the  outcome of  15
pregnancies incurred among 150  women working in  an unspecified lead
                              C-66

-------
trade during World War II.   Three of  these  women  had miscarriages -
an  incidence  seven  times  normal.  Unfortunately the  numbers were
too small  to  be assigned  statistical significance.  Lead exposure
was modest, air  lead  being  75  ug/m  and urinary lead excretion in
men working with  these  women being 75 to 125 yg/1.  A more  recent
Japanese study  also is  suggestive of miscarriages occurring among
women with  only modest  exposure (Nogaki, 1958).   These women were
the wives of lead workers.   Unfortunately,  the  actual level of lead
exposure was not  reported.
     It has recently been reported that  the  incidence of premature
fetal membrane  rupture  in term and preterm infants is  much  higher
30  to 50 miles west of a lead mining  area of Missouri (17 percent)
than in  a  Missouri  urban  area  remote  from  lead  mining  activities
(0.41 percent)  (Fahim,  et al.  1976).   Maternal  and  fetal PbBs at
birth also differed  significantly for normal  births vs. births with
premature membrane rupture.   Maternal and fetal PbBs for the  normal
deliveries were  about 14  and 4  yg/dl,  respectively,  whereas they
were about 26 and 13 respectively for mothers and infants with mem-
brane rupture.  This provocative study needs confirmation.   It is
difficult  to  understand,  for example,  why  fetal PbB  should  be so
much lower than maternal PbB in  all groups.
     There is a possibility that lead affects fertility as well as
the conception.   Lancranjan, et  al.  (1975)  reported  that signifi-
cant levels of  teratospermia occurred among  men  working  in a lead
storage battery factory.  Their PbBs  were 30  to 80 yg/dl.  Although
many studies have attempted  to  correlate semen quality with fertil-
ity, the extent to  which  abnormally-shaped  sperms  participate' in
                               C-67

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 fertilization is unclear.   Experimental  animal studies have shown
 reduced fertility of both maternal and paternal  origin (Stowe and
 Goyer,  1971).
      There have  been  numerous conflicting reports  concerning the
 occurrence of  chromosomal  aberrations   in  lymphocytes  of  lead-
 exposed workers  (O'Riordan  and  Evans,  1974;  Forni,  et al.  1976).
 The  reason for  these conflicting findings is not clear.   DeKnudt,
 et al.  (1977a)  suggest  that  ancillary  factors may be critical; for
 example, the  level of calcium intake.   They base this conclusion on
 the  lack of correspondence between lead effects in two widely sepa-
 rated lead-using plants, one being a secondary  lead smelter and the
 other  being a plant  manufacturing "tin"  dishes.   Lead  exposures
 were  roughly  comparable:   PbBs were on the order of  45-100  yg/dl.
 Severe  chromosomal  aberrations were found in one plant whereas  no
 such effects were seen in  the other.  They further point out that  no
 severe  aberrations  have been seen in  at least  some animal  studies
 in which lead exposure was heavy and nutrition  apparently  adequate
 (Jacquet,  et  al.  1977;  De Knudt,  et al.  1977b).  The  implications
of chromosomal aberrations which have been reported are not  known.
A recent report  by  Wibberley,  et al.  (1977),  which demonstrates a
striking increased incidence  of high placental lead associated with
stillbirths or  congenital malformations,  further  suggests that a
relationship exists between  intrauterine  exposure  to lead and re-
productive casualty.
Renal Effects
     There is considerable information in man concerning the renal
effects of lead.   Two distinctive effects occur  in both adults and
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children.  One. is reversible oroximal tubular  damage,  which  is seen


mainly with short-term exposure.  The other effect is reduced glo-


merular  function  which has  generally  been considered  to  be of a


slow, progressive nature.


     Tubular damage  is manifested as  the  Fanconi  triad of glyco-


suria, hypophosphatemia with phosphaturia,  and generalized amino-


aciduria.  The last-named manifestation appears to occur more con-


sistently  than  either glycosuria or  phosphaturia.    It was first


described more than 20 years ago  in lead smelter workers (Clarkson


and Kench, 1956).  In adults, the  condition probably is  uncommon at


PbBs below 70 ug/dl.   Thus,  in a recent series  of seven workers, all


of whom had PbBs 70 ug/dl, with a range of 71-109, none had amino-


aciduria or glycosuria.  Significantly, five had hemoglobins below


12 g/dl (Cramer,  et al. 1974).  Similarly,  in a series  of 15  infants


hospitalized  for  lead poisoning, all  having  PbBs _^_100  ug/dl at


entry, only three had aminoaciduria,  with  PbBs of 246, 299,  and 798


ug/dl  (Chisolm, 1968).


     Reduced  glomerular  filtration  with  attendant rise  in serus


urea concentration is generally  considered  to  be a progressive dis-


ease,  implying prolonged  lead  exposure.   It is  accompanied  by


interstitial  fibrosis,  obliteration  of   glomeruli   and  vascular


lesions  (Morgan, et al. 1966) .  It occurs at relatively low levels


of lead exposure, at  least  relative  to the levels  associated with


aminoaciduria.   For  example, in Cramer's  series of seven workers,


none of  whom  had  aminoaciduria, three had low  renal  clearance of

                          2
inulin  (^90  ml/min/1.73m ).   In another  study of  eight men with


occupational lead exposure (PbBs = 29-98) ,  four  had reduced glomer-
                               C-69

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ular filtration rates (Wedeen, et al. 1975).   Of these four cases,
one had a PbB of 48  yg/dl at entry.  The maximal PAH secretion rate
(Tm   )  was  also reduced,  indicating coexistent  tubular  damage.
Among the other three cases, two had only a marginal depression of

TnlPAH-
     From these  and other  studies, it appears  that  the  kidney is
sensitive to glomerular-vascular damage,  with an imprecisely known
threshold for effect which may be below PbB = 50 ug/dl.
Cardiovascular Effects
     Dingwall-Fordyce and Lane (1963)  reported an excess mortality
rate due  to cerebrovascular  disease  among  lead  workers.    These
workers were employed during the first quarter of the 20th century
when lead exposure  was  considerably higher than it  has  been more
recently.  There  was no similar elevated  mortality  among  men em-
ployed more recently however.  Similarly,  in  Cooper's  more recent
epidemiological study there was no  excess mortality attributable to
stroke or other diseases associated with  hypertension  or vasculo-
pathy  (Cooper  and Gaffey,  1975; Cooper,  1978).   It  would appear
from these studies  that the vascular  effects of lead only occur
with heavy industrial lead  exposure -  probably in excess  of what is
encountered today.
     There have been reports of heart failure (Kline, 1960) and of
electrocardiographic abnormalities  (Kosmider  and  Pentelenz, 1962)
attributable to  lead exposure.  However,  these  cases  have always
involved  clinical  lead  intoxication.   It does  not seem  likely,
therefore, that the heart is a critical target for lead effects.
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Miscellaneous Effects
     Sporadic  reports  of other biological  effects of lead  in  man
exist,  but  these are difficult to  evaluate  as to associated  lead
exposure.  They have frequently been reported only at high exposure
levels  and  only  by one or two investigators.  For example,  Dodic,
et al.  (1971) reported signs of impaired liver function in 11 of 91
patients hospitalized  for lead poisoning.  No information was  pro-
vided as to  indices  of  lead exposure.   Impairment  of  thyroid func-
tion has been  reported in moonshine whiskey  drinkers  hospitalized
for  lead  poisoning  (Sandstead, et  al.  1969) .  The degree of  lead
exposure was not  clearly indicated, but it  can be assumed to  have
been high.   Intestinal colic has long been recognized  as  a sign of
lead in  industrially exposed  people.   It probably also occurs  in
children  with  lead  poisoning.   Beritic (1971)   reported that  it
occurs  with  PbBs as low  as about  40 ug/dl.   This seems  unlikely
since the cases he reported also were anemic,  a condition  associat-
ed with  the considerably higher PbBs.   A number  of  studies have
suggested  that  a  relationship exists  between lead  exposure  and
amyotrophic  lateral  sclerosis (ALS).   The  most  recent  report  on
this examined plasma lead levels in  16 cases  of ALS and in 18 con-
trols and found significant differences  at the 0.05 level  (Conradi,
et al.  1978) .
     Finally, animal studies  indicate  that  relatively high  levels
of lead exposure  interfere  with resistance  to infectious disease
(Hemphill,  et al. 1971; Gainer, 1974).  There are no reports of  an
abnormal infectious disease incidence among  people with  high lead
exposure,  however.
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                      CRITERION FORMULATION
Existing Guidelines and Standards
     Since lead  is  ubiquitous  in the environment,  several govern-
ment agencies have become  involved  in regulating  its use.  The most
recent action was  taken by  the Consumer Product Safety Commission
(CPSC).  In 1977 the CPSC lowered the maximum allowable concentra-
tion of lead in  house paint to 0.06 percent.  At present  the Occupa-
tional Safety and Health  Administration (OSHA)  is  preparing a set
of  regulations  regarding  occupational  lead  exposure.   Similarly,
the U.S. EPA has set an ambient air lead standard.  The U.S. FDA has
provided  new guidelines  for the regulation  of  sources  of lead  in
foods and cosmetics.  Given  the multi-media nature  of lead exposure
to  man,  it  is  essential  that  any  action taken in  regard  to one
source,  such as water,  be coordinated  with  similar actions being
taken  for  other  media such as  air  and  diet.
Current  Levels  of Exposure
      Approximately  1 percent of  taowater samples have been found  to
exceed  the current  standard of  50  yg/1.   This is generally  a prob-
lem in softwater areas,  particularly where  lead  pipes convey  the
water  supply to the tap from the surface  connection.   The  contri-
bution of  the  diet is approximately  200  lag/day for adults.   For
children (ages  three  months  to nine years) the  diet contributes  40
 to 200 ug of lead per day.  On  the basis of current information,  it
 is impossible to judge how much  dietary lead is attributable to the
 water used in food  preparation.  The concentration of lead in ambi-
 ent air ranges  from  approximately 0.1 ug/m3 in rural  areas  to  as
 much as 10 yg/m3 in areas of heavy automotive traffic.
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 Special Groups at Risk
      In addition  to these usual  levels of exposure  from  environ-
 mental media, there  exist  miscellaneous sources which are  hazard-
 ous.  The level of exposure resulting from contact  is highly  vari-
 able.  Children with pica  for  paint chips or for soil may  experi-
 ence elevation in blood lead ranging from marginal  to sufficiently
 great to cause clinical  illness.   Certain adults may also be ex-
 posed to hazardous concentrations  of lead in  the workplace,  notably
 in lead smelters  and storage battery manufacturing plants.  Again,
 the range of exposure is highly variable.  Women in the workplace
 are more likely to  experience  adverse effects  from lead exposure
 than men due to  the fact that their hematopoietic  system is more
 lead-sensitive.
 Basis and  Derivation of  Criterion
      The  approach that will be taken here  in  assessing  the impact
 of lead  in water on  human health  is  basically the same as has been
 taken by the U.S.  EPA (1977)  for lead  in air.   The critical target
 organ or system must first be identified.  Then, the  highest inter-
 nal  dose of lead that can be tolerated without injury to  the target
 organ must be specified.  Finally, the impact of lead in  water on
 the  maximum  tolerated internal  dose  must be estimated, as  well as
 the  likely consequences  of  specific  reductions  in  the  maximum
 allowable concentrations of lead in water.
     In identifying the critical organ or  system, great reliance is
placed on the concentration of lead in the blood  (PbB) as an  index
of internal dose.   Such  an  indirect measurement  is  necessary be-
cause of the  multi-media  character  of  lead intake.  Tt  is virtually
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impossible to measure total lead  intake  in people  in any meaningful



way.  Because intake and output fluctuate greatly from day to day,



measurement of  total  lead intake would  require  long-term balance



studies.  Variables  have  a substantial  influence on  the  rate and



degree of lead  uptake  from the external environment.   Some groups



have proposed alternatives  to  PbB as a  measure  of  internal dose,



e.g., FEP and tooth lead.   FEP  is  not suitable because  it  is a bio-



logical response  to  lead.  As such,  it is subject  to influences



other than lead,  notably  iron deficiency.   Tooth lead is a poten-



tially useful index of  lead exposure,  but with the present state of



the art being what it is,  tooth lead  is  difficult  to interpret.  It



only provides an  integrated profile of past lead exposure.  One is



not able to say when the exposure occurred.  It has the additional



limitation of not being available on demand.  Teeth are shed spon-



taneously only in childhood. Moreover,  only a very small  data base



is available for dose-effect and dose-response using any measure of



dose other than PbB.  The use of PbB as a measure of internal dose



is widely accepted, simply because nothing better is available.



     Having specified that PbB  is the best measure of  internal dose



currently available, the next question concerns the lowest PbB lev-



els  at  which adverse health effects  occur.   Two recent  documents



(U.S.  EPA,  1977; WHO,  1977) have  been published  in which  "judgments



were rendered in  this regard (Table 12).  It will  be noted that the



estimates are strikingly  similar.   The  estimated no-effect levels



are  based  on limited  populations and  probably  are  lower to some



undefinable degree in the  total population at risk.  Slightly more



information  was available  to  the U.S.  EPA panel than to the WHO
                               C-74

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                              TABLE 12

           Summary of Lowest PbBs Associated with Observed

          Biological Effects in Various Population Groups3
 Lowest  Observed
  Effect Level
  (yg  Pb/100 ml
    Blood)
           Effect
 Population Group
     10
     15-20

     25-30

     40

     40
     40
     50
     50-60
     50-60
     80-100
   100-120
 ALAD inhibition
 Erythrocyte protoporphyrin
    elevation
 Erythrocyte protoporphyrin
    elevation
 Increased urinary ALA
    excretion
 Anemia
 Coproporphyrin elevation
 Anemia
 Cognitive (CNS)  deficits
 Peripheral neuropathies
 Encephalopathic  symptoms
 Encephalopathic  symptoms
 Children and adults

 Women and children

 Adult males
 Children and adults

 Children
 Adults and children
 Adults
 Children
 Adults and children
 Children
 Adults
             No  Observed  Effect  Levels  in  Terms  of  PbBb
 No Observed
Effect Level
(yg Pb/100 ml
    Blood)
         Effect
                                  Population Group
    10
    20-25
    20-30
    25-35
    30-40
    40
    40
    40
    40-50
    50
    50-60
    60-70
    60-70
    80
Erythrocyte ALAD  inhibition
FEP
FEP
FEP
Erythrocyte ATPase inhibition
ALA excretion in urine
CP excretion in urine
Anaemia
Peripheral neuropathy
Anaemia
Minimal brain dysfunction
Minimal brain dysfunction
Encephalopathy
Encephalopathv
Adults and children
Children
Adult females
Adult males
General
Adults and children
Adults
Children
Adults
Adults
Children
Adults
Children
Adults
Source:  U.S. EPA, 1977

Source:  World Health Organization, 1977
                             C-75

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panel since  it  reviewed literature through mid-1977,  whereas the
WHO expert groups reviewed literature only through 1976.  In addi-
tion, the U.S. EPA performed statistical calculations based on the
known distribution of blood lead levels in the United States.
     Both sets of data in Table  12 are in error in one regard.  They
use  the  term "anemia" inappropriately under  the "Effect" column.
What they  really mean is "decrement in hemoglobin."  Anemia is a
clinical term used to denote a degree of hemoglobin decrement which
is below the normal range for that class of individuals, e.g., men
or children.
     The question  that  arises  in considering  Table  12 is which  is
the critical effect?  Precisely  the same issue confronted the U.S.
EPA  in  its  deliberations  concerning establishment  of a national
ambient air  quality  standard for lead  (42  FR 630979).  It focused
on the lead  effects  in children  since they are more  sensitive than
adults.
     It ruled that the maximum  safe blood lead level for  any  given
child should be  somewhat  lower  than the threshold  for  a decline  in
hemoglobin level  (40 yg Pb/dl).   In considering how much lower this
limit should be,  the U.S.  EPA  cited the opinion of  the Center  for
Disease Control, as endorsed by the American Academy of Pediatrics,
that the maximum safe blood  lead level for any  given  child  should
be 30 yg/dl.  Based upon epidemiological and statistical considera-
tions,  the  U.S.  EPA  estimated  that if the geometric mean PbB were
kept at 15  yg/dl, 99.5  percent of children  would  have PbB  < 30
yg/dl.  This position provides a substantial margin of safety which
accomodates  minor excursions in lead exposure due  to adventitious
                               C-76

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 sources.    Controls on  lead  in  obligatory  media  (e.g.,  air  and
 water)  do not protect children from  the  hazards  of pica for lead-
 base paint chips or soil and dust contaminated with lead from such
 sources as fallout from the smoke zone of lead smelters.
      In its deliberations concerning an ambient air lead standard,
 the  U.S.  EPA estimated that the contribution of sources other than
 air  to PbB  is 10  to  12 ug/dl.  This  is  presumably composed over-
 whelmingly of dietary sources which,  in  turn,  is composed  of both
 food and  water.
      The  next question concerns the  contribution of  water  to lead
 exposure.   Only  three useful studies of  the  interrelationship  be-
 tween PbB and lead in drinking water  are available.   Overall,  the
 Moore,  et al.  (1977a)  study, the one by Hubermont, et  al.  (1978),
 and  the  calculations  made  from  U.S.  EPA  data  collected   in  the
 Boston  area  (Greathouse  and  Craun,  1976)  are  credible because they
 are  consistent with other  information concerning  the  curvilinear
 relationship between PbB  and  air Pb.   The implication of the equa-
 tion  describing the relationship between PbB and water lead  is that
 with  increasing lead in water,  the  incremental  rise in  PbB  becomes
 progressively  smaller,  as with air  lead  vs.  PbB and dietary lead
 vs. PbB (see "Contributions of Lead  from Diet vs. Air to PbB"  in the
 Pharmacokinetics  section).    The  water lead  vs.  PbB  relationship
 differs in one significant respect, however,  from the air lead vs.
 PbB relationship in that the baseline PbB  (0  water PbB)  is indepen-
dent of the contribution of water  lead to  PbB.   Thus,  regardless of
whether one starts with a baseline  PbB of  11  pg/dl,  as was indicat-
ed in the  Moore,  et al.  (1977a)  study  or whether one starts at some
                               :-77

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other  PbB  level, e.g.,  20 ug/dl,  the  add-on PbB  from  any given



level  in water will be the same.  Such is not the case in the Azar



analysis of  air  Pb  vs. PbB  (see  "Contributions  of  Lead from Diet



vs. Air to PbB"  in the  Pharmacokinetics section).  Here, the higher



the baseline, the less is the contribution of air Pb.  This is be-



cause log PbB is proportional to baseline PbB + log air concentra-



tion.  Future research  may provide better  insight  into whether this



discrepancy is real  and,  if so,  why.  The question is of some prac-



tical  importance.   For instance,  if  you have a  baseline  PbB (no



lead in water) of 30 yg/dl, such as in a child acquiring lead from



paint, it would  be of some importance to know  whether an additional



increment of lead in water would have the same .impact on PbB as it



would in a child  having a  baseline of PbB of 10 yg/dl.  An Azar-type



model would suggest  a lesser impact starting  from the higher base-



line PbB.



     So far as a specific recommendation regarding a water quality



for Pb  is  concerned,   a  stand  must be  taken using  the  available



data.   Beginning with the  assumption  that a PbB of 12  yg/dl is



essentially attributable  to food and  water   and  that  the  average



lead content of  water consumed  is  10 yg/1, approximately 5 ug Pb/dl



blood  (from Table 6) is attributable to  the  water that  is used in



food and beverage preparation  and in direct  consumption.   If the



water Pb were consistently consumed at the present  Pb  standard of



50 yg/1  instead  of  at  10 yg/1/ an  additional contribution  of ap-



proximately 3.4  yg/dl  to  PbB would  result (8.57  - 5.13  from Table



6).  This would  yield  a. total  PbB of  12 + 3.5 or  15.4  yg/dl, the



approximate maximum geometric mean PbB  compatible  with keeping 99.5
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 percent of the population under PbB = 30 ug/dl.  Thus,  based on most

 recent data,  the present water  standard  of  50  yg Pb/1 may be viewed

 as representing the upper limit of acceptability.  This criteria is

 based on empirical observation of  blood lead  in  human  population

 groups consuming their  normal amount of  water  and  food daily.  Spe-

 cific amounts of foods  or drinking  water consumed were not quanti-

 fied, but it can be assumed that they  reflect an average consump-

 tion  of water,  fish,  shellfish, and  other foods.

      All the  assumptions that  have  been made  in arriving at  an

 estimate of  the impact  of  lead  in  water on  PbB have been on  the

 conservative  side.   For  instance,  unpublished data from  the  Com-

 mission of the European Communities suggest that the impact of  lead

 in  water on PbB  is appreciably less  than has been estimated  from

 published  data  used in  this document [personal communication  from

 Alexander  Berlin,  et al.  (1978), Commission  of the European  Com-

 munities,  Luxembourg]1.   Furthermore, data  from  a  study  (Morse, et

 al. 1978)  of the effect of lead  in water on the PbB of  a population

 of children in a relatively small town are  reassuring.  They indi-

 cate  that among children  whose water supply contained  50 to 180 yg

 Pb/1, PbBs averaged 17.2  yg/dl2.
 Subsequent to the writing of this report, these data were submit-
 ted to the EPA by Dr. Berlin.  They were studied and judged not to
 alter the conclusions  arrived at  in  this document concerning PbB
 vs. lead in water (see  Appendix).
2
 It should  be pointed  out,  however,  that the  contribution  from
 other sources is  not indicated, thus, the  relative water lead con-
 tribution is unknown.
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     Finally, there remains the  issue  of  the carcinogenic effects
of lead.   Using  data from one  species of laboratory  animal  (the
rat)  it was  possible  to  construct  a  seemingly valid dose-response
curve and to calculate a dietary level of  lead which would predict
an incidence of cancer in 1:100,000 people.   This calculated diet-
ary level of lead  is  29  yg/kg.   Since  this  estimate includes lead
from all  sources,  its implications  are beyond the  scope of  this
document.   It should be  noted,  however  that the  International
Agency for Research on Cancer,  Lyon,  France  considers the experi-
mental animal evidence to be of dubious  significance with  regard to
man (IARC, 1972) .
     The Agency  has  not  yet resolve all  of  the issues concerning
the potential carcinogenicity of  lead,  but will complete its review
in the near future.  All  of the  data will  be  subjected  to  an exten-
sive peer review by outside experts  and in-house  scientists.   De-
pending upon the final conclusions  of  the  review,  the water quality
criteria for lead may be re-evaluated.
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                              C-103

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                            APPENDIX*



     Results  of  the  research  examined  in  the Commission  of the

European Communities  (CEC) paper are summarized in Tables 1 and 2.

The data presented in Table 1 are equations developed by the  auth-

ors concerning the relationship of  blood  lead  (PbB)  to water lead

(PbW).   Table 2 consists of calculations  of  the contribution of 100

yg Pb/1 of  water to PbB  (as yg/dl) .   Some of  these calculations were

made by  Berlin,  et  al.  (1978) , interpolating  from data points in

the articles cited.   Others were made using the equations provided

by the authors of the articles cited.

     Three types of equations are presented:

     (1)  PbB = a + b PbW

     (2)  PbB = a + log PbW
     In all cases "a" is the baseline expressing PbB at PbW = 0.  Of

these three mathematical relationships,  the  third  appears  to be the

most valid for two reasons:   (1)  the  largest number of  subjects are

involved in studies using this  equation, and  (2)  it corresponds to

the analysis of U.S. EPA data  (Greathouse  and Craun, 1976)  as cited

in the  lead  criterion  document,  which also  involved  a very large

number  of  subjects.   Moreover calculations  made of  PbB vs.  PbW

using the U.S. EPA data were  for  females aged 20 to 50, a  sub-popu-

lation  which  probably  gets a  larger proportion  of  its water from
*Summary of "Research of PbB vs. Lead in Drinking Water  in Europe"
 as presented  by A. Berlin,  et al. (1978) , Commission of the European
 Communities.
                              C-104

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                                                  TABLE 1

                                    Relationships  between  PbW and PbB*
              Relationship
                                          Remarks
                                         Reference
        PbB = 0.018 PbW +22.9
                               r = 0.417
                               PbW = ng/1
                               PbB = vig/100 ml
                               First morning flush
                                   Addis and Moore, 1974
        PbB = 0.76 + 0.15 PbW

        PbB = 0.80 + 0.20 PbW
                               PbW and PbB in ymol/1
                               r = 0.58, first morning flush

                               r = 0.52, running sample
                                                                          Moore, 1977a
o
i
M
O
Ln
PbB = 0.533 -f 0.675   PbW

PbB = 0.304 + 1.036 3 PbW
PbW and PbB in ymol/1
first morning flush

running sample
                                                                          Moore, et al. 1977
        PbB = 9.62 + 1.74 log PbW
                               PbW in pq/1 PbB in ug/lOOml
                               first morning flush
                                                                          Lauwerys, et al. 1977
        PbB = 0.8 + 0.19 PbW

        PbB = 0.8 -I- 0.53 PbW
                               PbW and PbB in ymol/1
                               first morning flush

                               full flush (paired samples)
                                   Moore, 1977b
        PbB = 19.6 + 7.2 PbW
                               PbW in ppm, PbB in ug/lOOml
                               first morning flush
                                                                          Elwood, et al. 1976
        PbB = 20.7 -I- 12.6 PbW
                               As above.
                               Re-evaluated data
                                   Beattie, et al. 1976
        *Source:   Berlin,  et al.  1978

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                                                 TABLE 2

                           Increment  in  PbB  for  an  Increase  of  100  yq/1 in Pbw

                                  (for Concentrations  around 100  yg/1) *
         Increment  in  PbB
                                  Remarks
                                               Reference
o
i
i—•
o
cr>
1.3 yg/100ml


1.2 nq/100ml


3.4 yg/lOOml


3.3 pg/lOOml


1.8 ug/100ml


2.0 vig/100ml



6.0 yg/lOOml



3.9 yg/100m]



0.83 pq/lOOml
For running sample (linear
interpolation)  20-1040 yg/1 PbW

First flush (linear inter-
polation)  10-250 yg/1 PbW

For running sample (linear
interpolation)  10-250 yg/1 PbW

For first flush (linear inter-
polation)  35-350 yg/1 PbW

Using the linear equation derived
by the authors

Using the linear equation derived
by the author for running water
samples.

Using the non-linear equation
derived by the authors for
running water samples.

Using the non-linear equation de-
rived by the authors for first
morning flush.

Using the log equation derived
by the authors

In view of the low PbW value,
the extrapolation is uncertain.
                                                                         De Graeve,  et al.  1975
                                                                         Beattie,  et al.  1972
                                                                         Covell,  1975
                                                                         Addis,  et al.  1974
Addis, et al. 1974
                                                                         Moore,  1977a
                                                                         Moore,  et al.  1977
                                                                         Moore,  et al.  1977
                                                                         Lauwerys,  et al.  1977
                                                                         Vos,  et al.  1977

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                                              TABLE 2  (Continued)
o
i
          Increment in  PbB
            1.9  ug/100ml


            5.3  yg/lOOml


            0.72
            1.3 yg/lOOml
      Remarks
Using the linear equation derived
by the authors for morning flush

Using the linear equation derived
by the authors for full flush

Using the linear equation derived
by the authors for morning flush.

Using the re-evaluated linear
equation derived by the authors
for morning flush.
                                                                                Reference
Moore, et al. 1977
Moore, et al. 1977
                                                                          Elwood,  et al.  1976
Beattie, et al. 1976
         *Source:  Berlin, et al. 1978

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the domestic supply than the population at large.  In that regard,
the only comparable population was  70  pregnant female subjects  in
the study of Hubermont, et al. (1978) cited in the CEC document  as
Lauwreys, et al. (1977).
     In  summary,  of the studies  cited in the CEC document, most
weight should probably be given to the Moore, et al.  (1977a) cita-
tion, on the basis  of  large  numbers  of samples of water and study
subjects, and to the Hubermont, et al.  (1978)  study on the basis  of
a substantial number of subjects  which were  probably partaking  of
more of the domestic water supply than other  sub-classes by virtue
of pregnancy and sex.
     So  far  as  the actual calculations in Table 2 are concerned,
there is one error.  The CEC document calculates that the equation
of Hubermont, et al. (1978)   (cited as Lauwreys, et al. 1977) would
predict that PbW at 100 yg/1 would result in  a PbB contribution  of
0.83 yg/dl.  The error  is obvious.  In the  equation, the PbB contri-
bution of water  is  given by  PbB  = 1.74 log PbW.   In fact,  0.83 =
1.74 log 3,  not 1.74  log 100.   The correct  calculation  is PbB =
1.74 X 2 = 3.48, since log 100 =  2.
     Of the 13 estimates of  PbB vs.  PbW in Table  2, only 5 could  be
verified.  These were Addis,  et al.   (1974) (interpolation),  Addis,
et al.  (1974)  using authors'  equation,  Moore  (1977a)  using author's
equation,  Beattie,  et  al.   (1976)  using  author's  equation,  and
Moore,  et  al.  (1977) ,  non-linear  morning  flush.   Of the remaining
nine, one  was miscalculated  by CEC  and the  remaining  eight could
not be  verified by this author because the  caper was unavailable
(Covell, 1975;  Elwood,  1976), or  because the  necessary  data were
                              C-108

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not  in the paper  (De Graeve, et al.  1975; Moore,  et  al.  1977  using
non-linear equation  for running  water;  Moore, et  al.  1977  using
linear equation for morning flush and running  water  calculations),
or because it was not possible  to  see how CEC made an interpolation
from the data cited  (Beattie, et al. 1972).
     In summary, the  two most credible studies  among  the  nine  actu-
ally scrutinized  in  this addendum  were  the  very  ones utilized  in
the criterion document for lead.  Of the  two reviewed  by the CEC but
not  examined  at the  time  of  this  writing  (Covell,  1975; Elwood,
1976) ,  one was reviewed prior to development of the criterion  docu-
ment and  rejected on  the basis  of the seemingly  inappropriate use
of a linear regression model (see "Contributions  of  Lead from Diet
vs. Air to PbB" in the Pharmacokinetics  section).   It is therefore
concluded that information provided  by CEC does not alter the  eval-
uations made  in the criterion document.
                             0109

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