"n - 'it t -V < ues -me
           Toxic Sui-'su-if-rss
           IVash - gton 3C ?04t-0
Identification and
Evaluation of
Potential
Physiological
Toxicity Assays
Final
Report

-------
          IDENTIFICATION AND  EVALUATION
            OF POTENTIAL PHYSIOLOGICAL
                 TOXICITY ASSAYS
 George H. Kidd, John M.  Rice,  Melanie E.  Davis,
Mark A. Hurst, Mickey F.  Arthur,  Steven E. Pomeroy
               and Martin L.  Price
                     BATTELLE
              Columbus Laboratories
                 505 King Avenue
              Columbus, Ohio  43201
                   Final  Report
             Contract No. 68-01-5043
                   Prepared for
       U.S. Environmental Protection Agency
    Office of Pesticides and Toxic Substances
                 Washington, D.C.
                   January 1980

-------
                                  DISCLAIMER

         This report  has  been reviewed by the Office  of  Pesticides and Toxic
Substances,   U.S.   Environmental   Protection   Agency,   and   approved   for
publication.  Approval does  not  signify  that  the contents necessarily reflect
the views and policies of the U.S. Environmental Protection Agency,  nor does
mention  of  trade   names  or  commercial   products  constitute  endorsement  or
recommendation for use.

-------
                                   SUMMARY

           Battelle's  Columbus Laboratories has contracted with the  Office  of
Pesticides  and  Toxic  Substances,  U.S.  Environmental  Protection  Agency,  to
develop a  list  of  physiological  assays as  potential toxicity  screening  tests
and  to  assess  the  strengths and  weaknesses  of  these  assays (Contract No.
68-01-5043).  After  an extensive  literature  search,  Battelle has compiled  a
list of 24 assays,  covering  all  of  the categories cited  by OPTS/EPA in  its
Technical   Directive.     Brief  descriptions  of   assay  methods   and  tables
containing  critiques  .of  each  assay  are  presented,  along  with  literature
references for all  of  the assays.

-------
                              TABLE OF CONTENTS



                                                                   Page

Disclaimer 	      i

Summary	     ii

INTRODUCTION 	      1

    Initial Identification and Screening of Potential
      Assays 	      2
    Organization of Information About Assays 	      7
    Explanation of Data Tables Accompanying Each Assay 	      7
    Assays From Woodard (1976) 	     11

DISCUSSION AND RECOMMENDATIONS 	     15

POTENTIAL TOXICITY ASSAYS—DESCRIPTIONS, METHODS, AND
  ASSESSMENTS	     19

          Nitrogen Fixation	     19
          Photosynthesis 	     20
          Respiration	     28
          High-Energy Phosphate Production 	     30
          Growth and Cell Division	     34
          Catalysis (Enzymatic Activities) 	     47
          Other Cellular Processes 	     55
          Other Potential Physiological Toxicity Assays	     67

TABULAR COMPARISON OF CRITERIA 	     71

REFERENCES	     78

APPENDIX:  LITERATURE SEARCH METHODS 	    A-l


                             LIST OF TABLES


Table 1.  Assays Considered but Not Evaluated	      3

Table 2.  Potential Toxicity Assays Addressed in This
            Report 	      5

Table 3.  Commercial Sources of Test Organisms 	      6

Table 4.  Acetylene Reduction	     21

Table 5.  Hill Reaction	     23

-------
                        LIST OF TABLES (CONT'D.)


                                                                    Page

 Table 6.  Greening	     25

 Table 7.  RuDP Carboxylase Activity	     27

 Table 8.  Photosynthetic Oxygen Evolution	     29

 Table 9.  Respiration in HeLa Cells	     31

 Table 10.  Adenylate Energy Charge 	     33

 Table 11.  Cloning L929 Mouse Cells	     36

 Table 12.  Protozoan Clonal Viability	     38

 Table 13.  Human KB Cell Growth Rate	     40

 Table 14.  Human Embryonic Lung Fibroblast (WI-38)
             Cytotoxicity	     42

 Table 15.  Mitogen Stimulation of Lymphocytes	     44

 Table 16.  Chick Embryo Development	     45

 Table 17.  Trypan Blue Dye Exclusion by Human KB Cells	     48

 Table 18.  RNA Polymerase Activity	     50

 Table 19.  Adenyl Cyclase Activity	     52

 Table 20.  Lysosomal  Enzyme Release	     54

 Table 21.  Macromolecular Synthesis in Human KB Cells	56

 Table 22.  Cyclosis	     58

 Table 23.  Hemolysis	     59

 Table 24.  Protozoan  Vacuole Contraction	  .     62

 Table 25.  Protozoan  Motility	     64

Table 26.  Phagocytosis by Alveolar Macrophages	     66

Table 27.  Ami no Acid Transport	     68

Table 28.  Source of  Test  Organism	     72
                                  i v

-------
                        LIST OF TABLES (CONT'D.)


                                                                    Page

Table 29.  Test Organism and Organismal  Level  or
              Parameter Evaluated	     73

Table 30.  Special Equipment	     74

Table 31.  Times,' Cost, and Technician Skill	     75

Table 32.  Data Base and Comments	     76


                            LIST OF FIGURES
Figure 1.  Schematic representation of viability test
             adapted to toxicity testing 	     37

-------
                                 INTRODUCTION
          In this report, Battelle's Columbus Laboratories develops a  list  of
potential  cellular,  organellar,  and  enzymatic  toxicity  tests  (here  collec-
tively  referred  to  as  physiological  toxicity  tests  or assays)  for  rapid
screening  of  potential  toxicants  by  the Office  of  Pesticides  and  Toxic
Substances-Environmental    Protection   Agency    (OPTS/EPA,    Contract    No.
68-01-5043).   This  study also  documents,  on the basis  of  a  review  of  the
published scientific literature and of ongoing research  efforts,  the strengths
and weaknesses of selected physiological  toxicity test methods.
             At  present,  the testing  strategies proposed for  premanufacture
evaluation  of  chemical  hazards  to ecological systems utilize 96-  or  48-hour
acute toxicity tests  on fish or  invertebrates,  respectively, as the  primary
(or only) screening methods to identify the  need for further testing.   There
are several  problems  with  these  assays.   First,  such acute  tests are  usually
poor predictors of the results of chronic  studies, phytotoxicity  tests, behav-
ioral tests, and multispecies ecological  studies.  Second, the standard short-
term acute tests depend significantly, not  only  on the toxic  biological activ-
ity  of  a  chemical  substance,  but also  on  its solubility,  dispersability,
and/or  ability  to penetrate  target  cells  or  organs in  the test  organisms.
Such penetration  is  highly  variable among species.   Third,  the  time  and cost
of the standard acute tests mentioned above are  great.
           To  circumvent  the  problems arising from the  fish and invertebrate
toxicity tests,  a  battery of  rapid,  in vitro,  physiological  tests could  be
developed as  a  first  screening tier of a  step-sequenced testing strategy for
assessing ecological  effects  of  chemicals.   These physiological  assays  would
measure  effects  on major metabolic  and  cellular functions,  and  from  these
functions,  would  attempt  to  predict  effects  on  various  test species  and  on
ecosystem  function.    It  is  further  assumed  by  this  approach  that  chronic
effects are  the  result of  chemical  toxicity at  the cellular or  subcellular
level, and  that  these rapid,  physiological  tests can predict chronic effects.
In sum, physiological  assays might best serve as preliminary tests in ecologi-
cal effects test schemes.

-------
          Described  below  are  the theory and experimental  procedures of these
 potential  physiological  toxicity assays.   Each  assay method  is  evaluated  by
 several criteria, including the  advantages and limitations, response to chemi-
 cals, and special equipment required.  Pertinent references are included along
 with the criteria for  each assay, as well as in bibliographic form at the end
 of the report.

 Initial Identification and Screening of Potential Assays

         In the  initial  stage  of Battelle's  literature search (see Appendix),
 some  45  potential   toxicity  tests  were  identified  for  consideration  by
 OPTS/EPA.  Potential  assays were  either  of  particular interest  to  OPTS/EPA,
 referenced in Woodard (1975), or  independently identified by Battelle.
         Of the 45 physiological assays considered, 21 have little promise for
 development as  rapid toxicity screening  tests  (Table 1).   The assays marked
 with an asterik (*)  in Table 1 were not considered strong candidates for rapid
 toxicity screens  because  they  required  use  of  isolated organs  and tissues.
 Isolated organs and  tissues  have been very useful in  studying the mechanisms
 of toxic action and in providing an understanding of mechanisms by which chem-
 icals exert toxic effects.  In this  role,  such  systems should become increas-
 ingly important.  However, the  use  of isolated  organs has serious limitations
 for studying  physiological or  toxicological  effects, partly  because  of  the
 modulating systems existing in the whole organism which can either increase or
 decrease a chemical  effect.  The usefulness  of organ  systems  for rapid toxi-
 cological screening  remains  limited, primarily because  such  systems are most
 useful  for screening large numbers of  chemicals  for  a site-specific effect  as
 opposed to  screening a  chemical  for  multiple  biological  effects.   Also,  in
most cases, isolated organ assay  systems  use  almost  as many animals  as  an  in
 vivo test  would  require.   Consequently,  there are  little savings  in total
 animal  usage.   Given these considerations,  no  rapid, physiological  toxicity
 assays  using tissue  or organs are critiqued in this report.
           Other potential assays (oxidative activity in  rabbit  endothelium,
chromosome  breakage   in  human  leukocytes,  oxygen  consumption  by  human
 leukocytes)  were rejected  because of GLP  problems.   Endothelia and leukocytes

-------
TABLE 1.  ASSAYS CONSIDERED BUT NOT EVALUATED  IN  DETAIL  IN  THIS REPORT
    Plant callus growth
    Inhibition of cell  division of plant  suspension cultures
    Glycogen conversion in perfused rat liver*
    Malting
    Inhibition of axon myelation*
    Invertase activity in duodenum culture*
    Epithelial growth in mouse kidney tissue*
    Cholinesterase inhibition in cerebral  cortex*
    Collagen synthesis in human pleura cultures*
    Vitamin 8^2 uptake in monkey illeum*
    Trachea! muco-ciliary transport rate*
    Aldosterone synthesis in the adrenal  gland*
    Fatty acid synthesis in adipose tissue*
    Mutagenesis in Saccharomyces**
    Mitotic frequency in duck embryonic lung cells (L132)  t
    Oxidative activity in rabbit endothelium t
    Chromosome breakage in human leukocytes t
    Enzyme leakage in perfused liver*
    Oxygen consumption by human leukocytes t
    Osmotic and ionic changes in leaf guard cells
    Inhibition of regeneration in Hydra
     * Assays described in Woodard (1976)—Organs and Tissues.
    ** Assays described in Woodard (1976)--Bacteria, Fungi,
       Protozoa, and Plant Cells.
     t Assays described in Woodard (1976)—Mammalian and Avian
       Cell Culture Systems.

-------
 are  genetically and  developmentally  heterogeneous,  and  thus  create problems
 with  quality  control  and uniformity of response.  Malting,  osmotic and ionic
 changes  in  leaf guard cells and  inhibition  of regeneration  in Hydra were not
 considered  promising  assays  because a  very small, if any, data  base on toxic
 chemical  effects existed.   Those  potential  toxicity  screens  involving plant
 tissue  cultures (plant  callus  growth, inhibition of  cell  division  of plant
 suspension  cultures)  were  rejected because a very  long time (as much  as  2
 months)  is  required to  complete a  toxicity  assay  involving  callus or suspen-
 sion  cultures.   Also,  plant  cell  cultures are easily contaminated, especially
 since  aseptic  conditions must  be  maintained  without   antibiotics  for  the
 duration  of  the  assay.    The  final  tv/o  rejected  assays   [mutagenesis  in
 Saccharomyces and  mitotic frequency in duck embryonic lung  cells (L132)] may
 be  effective for  screening  a wide  variety  of  mutagens.    But,  while  all
 mutagens  are  toxicants,  not  all  toxicants  are  mutagens.   These  assays  are
 probably responsive only  to chemicals  that interact with or influence DNA.
          The remaining  assays,  which are evaluated in  this  report, appeared
 reproducible, well -documented, and  straightforward (Table 2).
         The selection of these final 24 assays was based on several criteria.
 First,  the  test organism  in  each of  these  assays  is either commercially
 available or  easily  grown or  cultured from commercially available materials
 (e.g., seeds)  (Table  3).  Second,  the methods for  each  assay are well docu-
mented and have  been  performed in many laboratories worldwide.   For example,
 estimates of  RuDP  carboxylase  activity  have  been  made   in  many laboratories
throughout the U.S.,  Japan, Europe, and many other locations.   Third, many of
the physiological  processes measured  by  these  assays  have been  tested with
some  chemicals  for possible toxic  effects.    So, at  least  some  data  base on
toxic chemical  effects  is available  for  each  of the 24  assays.   Fourth, the
selected  assays  are  generally more  rapid (assays  per  unit  time)  than  the
rejected candidate assays.
          Each  of  these  protocols  is  currently  the most streamlined process
available.   With  more  research  and  development, the potential  for further
streamlining exists.

-------
       TABLE  2.   POTENTIAL TOXICITY ASSAYS ADDRESSED IN THIS REPORT
      Gel 1 ill ar process
        Specific assay
 Nitrogen  fixation*

 Photosynthesis*




 Respiration*

 High-energy phosphate production

 Growth and cell division*
 Catalysis (enzymatic activities)
 Other cellular processes
Acetylene reduction

Hill reaction
Greening
RuDP carboxylase activity
Photosynthetic oxygen evolution

Respiration in HeLa cells**

Adenylate energy charge

Cloning L929 mouse cells**
Protozoan clonal viability
Human KB cell growth rate
Human embryonic lung fibroblast
  (WI-38) cytotoxicity
Mitogen stimulation of lymphocytes
Chick embryo development**
Trypan blue dye exclusion by
  human KB cells

RNA polymerase activity
Adenyl cyclase activity
Lysosomal enzyme release
Macromolecular synthesis in KB cells

Cyclosis*
Hemolysis*
Protozoan vacuole contraction*
Protozoan motility*
Phagocytosis by alveolar macrophages
Ami no acid transport
 *Subjects mentioned in EPA directive to Battelle.
**Subjects mentioned in Woodard (1976).

-------
            TABLE 3.  COMMERCIAL SOURCES OF TEST ORGANISMS
         Organism
  Source
 Algae:

    Scenedesmus
    Euglena
    Chlorella
    Chlamydomonas
    Chara
    Elodea
    NlteHa

 Bacteria:

    Azotobacter vinelandii
    Escherlchia coll
    Clostrldlum pasteurianum

 Protozoan:

    Tetrahymena pyrlformls

 Human Cell Lines

    HeLa
    KB
    WI-38
    Human erythrocytes

Other mammalian Cell Lines:

    Mouse L929
    Mouse lymphocytes
    Rabbit alveolar macrophages
    Rat erythrocytes

Higher Plant (seeds):

    Spinach oleracea
    Hordeum vulgare
    Phaseolus vulgaris
    Canavalia ensiformis

Higher Animal:

    Mice
    Rabbits
    Rats
    Chickens
ATCC*
ATCC
ATCC
ATCC
Starr**
Starr
Starr
ATCC
ATCC
ATCC
ATCC
ATCC
ATCC
ATCC
Calbiochem
ATCC
Mouse colony
Rabbit colony
Rat colony
DeKalb Agresearch t
DeKalb Agresearch
DeKalb Agresearch
DeKalb Agresearch
Jackson Labs, Bar Harbor, ME
Jackson Labs, Bar Harbor, ME
Jackson Labs, Bar Harbor, ME
Reliable local hatchery
 *ATCC—American Type Culture Collection.
**Dr.  Richard Starr,  algal  culture  collection,  University  of Texas at
  Austin.
t Or other company with  genetically homogeneous  seeds  [good sources
  can be confirmed by the American  Seed  Trade Association  (ASTA)].

-------
Organization of Information About  Assays

         In the following pages,  24 physiological  assays  which  could  be  devel-
oped for rapid toxicity testing are described  and  assessed.   As  shown  in Table
2, assays  are organized under seven  different  cellular  processes which  were
suggested by OPTS/EPA.
            The information on each assay  is  divided  into two  parts.   First,
there is a brief description  of  each  assay along with the biological meaning
of the test results.   Second,  data tables accompany  each  assay  description for
easy access of relevant  information.  The  protocols and  data tables  are  com-
plementary,  so both  should  be  considered for  objective evaluation of  the
individual assays.  The  information  organization  described above allows  easy
evaluation and comparison of individual  assays.

         A tabulation summarizing pertinent data on  the assays  is presented in
the Discussion and Recommendations section at  the  beginning of  the report.

Explanation of Data Tables Accompanying  Each Assay

          Each potential  toxicity  assay  has been assessed according  to seven
criteria.  The scope and meaning of each  criterion are given below.

Test Organism—
         A representative  test organism  (or organisms) is suggested  for each
assay.   Each  organism  mentioned  in this  report  has  been  the object of most of
the particular studies  in toxicity evaluations.  Observations  have  been made
on these organisms,  and  on others mentioned in  certain assays, in  terms of
growth and survival, hallmark  metabolic  process,  or changes  in gross morphol-
ogy  or  ultramorphology.    These  test organisms  were also selected because
relatively large quantities of these  cells  or tissues  can  be quickly grown or
inexpensively  purchased  (Table 3).   Enzymes  used  in  certain  toxicity  assays
(e.g., RNA  polymerase activity)  were selected  because of their abundance in
particular tissues,  commercial availability,  stability  of  activity,  or  rele-
vance of the metabolic process in which the enzyme participates.

-------
 Advantages  and Limitations—
            Some  advantages  and limitations  of  each method,are  listed  in  the
 following tables  and these are straightforward  in interpretation.
         One factor considered was the level of technical skill needed to per-
 form  each  assay.   We  identified  three different levels of technical competen-
 cy.    Highly  skilled  technicians  are  defined as  individuals  with  master's
 degrees and research experience.  Skilled technicians are individuals who have
 had college or university research  experience  and who hold a technical  bache-
 lor's  degree.  Unskilled technicians  are defined as individuals with a minimal
 scientific  background  (e.g.,  associate  or  junior  college  degree).    If  un-
 skilled technicians could be used to  perform an assay, this fact was listed as
 an advantage.   On the other hand,  if a  skilled or highly  skilled technician
 was required, this  fact  was  considered a limitation.  As each particular assay
 method is  standardized and  becomes routine  for a  given  laboratory,  a  lesser
 degree of  technical  skill than  mentioned  in the table  for  that  assay  may be
 utilized.

 Response to Chemicals—
            Each potential toxicity  assay was assessed with  regard to its  re-
 sponse to certain chemicals.   Most of these  assays  have not been developed as
 toxicity tests  as  such,  but  were  used to  study  certain  physiological  pro-
 cesses.  Any toxicity  testing  has been incidental  (i.e., to determine physio-
 logical effect of a chemical, not to  determine a chemical's toxicity).
           A sampling  of chemicals  and chemical classes has been  included in
 each table  to give an  idea about the  range of chemicals that affect the assay.
Other  chemicals  may (or may not) affect  the  physiological  process in  each
 assay, but  these  chemicals  have  either  not  been  studied or were not revealed
 during our  literature search.
            In  every assay listed  (except hemolysis  and lysosomal  enzyme  re-
 lease), the term  "response to  chemicals" refers to  chemical  inhibition  of  the
 observed physiological  process.   For instance, in  respiration  in HeLa  cells,
malonate  lowers (or in sufficiently high concentrations, stops) mitochondrial
oxygen uptake.   The chemicals  listed  in  hemolysis,  however, promote the lysis

-------
of red blood cells rather than inhibit it.   In  each  assay  the  chemicals  listed
affect the physiological  process  in  a  concentration-dependent  manner.
           When available, the concentrations of some chemicals  affecting  the
assays were included.  Affecting chemical concentrations  v/ere abbreviated  EC,
I,  LC,  or  MEC.   ECX  (effective   concentration)  is the concentration that
induces detrimental  effects in x percent of the test organisms.   For  example,
in the  hemolysis assay,  £659  would be  a  chemical  concentration that  causes
50 percent  of  the red blood  cells  to lyse.   Ix  is defined  as the  chemical
concentration  causing  x  percent  inhibition  of a physiological  process  (e.g.,
greening  or  enzymatic catalysis activity).    LCX  (lethal  concentration)   is
the chemical concentration causing  the death of x  percent  of the test  cells or
organisms.   For  instance,  LCX is  used for  chemicals  causing chick  embryo
death.  MEC  (minimal  effective concentration)  is defined  as the lowest  chemi-
cal concentration at which toxic effects are first  observed.   MEC is used in
the mammalian cell culture assays.
          In the assays examined in this report (Table 2),  the  test  chemicals
have  elicited  a  unidirectional  physiological  response  (e.g.,   inhibition  of
respiration, inhibition of KB cell   growth rate).   It is  possible that  future
studies may  reveal  chemicals  having an opposite effect (e.g.,  stimulation of
respiration, stimulation  of  KB  cell   growth  rate).    Would  a   chemical  that
stimulated, instead of inhibited,  a cellular process be  considered toxic?

Assay Time—
         The times required for each  assay  (including preparation time, tech-
nician time, etc.)  were  assessed  and  are included  in each  data table.   There
are four  numbers  listed opposite Assay Time  in each table.   The first  number
is  the  time (in  hours)  to perform an assay  set  (i.e.,  one  chemical, three
replicates of  each  of  five concentrations).   If several  replicates  of  diffe-
rent  chemicals  could  be assayed simultaneously, this was  considered  an  advan-
tage.  It was  considered  a limitation  when  an  assay  set  required long periods
of time or when only one  individual assay could be  completed at a  time.  The
second number  listed in the Assay Time category is the total time for an assay
set to be  completed.   This includes cell  growth period,  solution preparation,
data  recording,  and laboratory cleanup and  is  an estimate   of  time   from

-------
                                      10

 start-up  to  expression  of  results.  The third  number is total technician time.
 Since  technicians  can  do  several  operations  simultaneously  (e.g.,  prepare
 solutions  during  cell  growth  period)  and  some processes may continue unsuper-
 vised  overnight,  this  number may be  significantly less than the  total  assay
 time.   The  last  number is the  administrative time required.   This includes
 Ph.D.  supervision  time, managerial  time,  data  analysis, and reporting  of re-
 sults.   It was necessary  to  separate this from technician  time  since  a more
 highly trained person is usually required for administration.  These times are
 estimated  for assays  that are in the  late  developmental  stage.   As the assay
 method  is  standardized and  becomes  routine,  times   would probably  become
 shorter.

 Specialized Equipment--
           Specialized  equipment  needed to accomplish each  assay  is listed in
 the table  accompanying  each assay description.  Not all equipment required for
 each test  is  presented.  All of these potential  toxicity  assays can  be per-
 formed routinely  only  in a laboratory equipped  with  basic analytical  instru-
 ments  (centrifuges, balances,  etc.),  minimal  cell  culture equipment (incuba-
 tors, culture dishes or flasks, etc.), and biochemicals (buffers, metabolites,
 etc.).  If the other necessary special equipment  was  rare  or costly, this was
 considered  a limitation.   For  example,  mammalian cell  culture  facilities,
 needed in  many  of the  mammalian cell  cytotoxicity assays,  require a  sterile
 working area  such as  laminar flow  hood  or transfer room.   Such  apparatus is
 probably  not  standard   in  most  laboratories  and  may  cost  as much  as  $7000.
 Other special equipment, such as a  spectrophotometer  or colorimeter, is rela-
 tively inexpensive and  is  found  in  many laboratories.   Such special equipment
 is listed  in the data  tables but is not considered a limitation.
         The assays listed in Table 2  already  involve  certain levels of auto-
mation.  For  example, protozoan  motility  utilizes  a microphotography unit and
RNA polymerase activity  uses  a  multipurpose filtration manifold.   Many other
 assays (e.g.,  mitogen  stimulation  of lymphocytes,  adenyl  cyclase activity,
 amino acid transport)  are  partially automated  by  using scintillation counters
with statistical  data  analyzers.   The need for  automation  of  any particular
assay is  dependent on  the  volume of chemicals  to  be tested--if  many chemicals

-------
are to  be tested, automation  or development of automation  v/ould  ensue.    In
several  assay descriptions we  suggest  potential  points  for automation  (e.g.,
use of computer and TV in protozoan motility  assay).

Cost—
          The estimated cost  for an assay set  is  included in each data table
as  well  as  in a  comprehensive comparison  table  at the end  of  the  report
(Table 29).
           To calculate the estimated costs, the technician's hourly  v/age  was
multiplied by the total number of technician  hours,  and  this  was multiplied by
a factor of 2.64.  This  is the estimated  labor factor for Battelle's  Bioenvi-
ronmental Sciences Section, and  is used for  determining the  approximate total
cost for  performing  a task,  including labor, supplies,  use  of  equipment,  and
use of other facilities (e.g., electricity,  water,  maintenance).
          The technicians'  hourly wages are  based upon average pay  for similar
technicians at  Battelle,  including 2 weeks  annual  vacation  and other  fringe
benefits.  Annual  salaries of these technicians are:   highly skilled techni-
cian, $18,000;  skilled technician  $12,000;  and unskilled  technician,  $9,500.
The cost  of supervision by  a Ph.D.  level  research scientist  and  managerial
costs are  also  included.   These annual salaries are estimated to be $25,000
and $35,000 for a Ph.D. scientist and manager,  respectively.
         The approximate costs listed in this  report  are  only for  purposes of
comparison  of  assays.   Actual  costs  may vary  20  to  25 percent from  these
figures at different  laboratories.  Developmental work  on the assays  would be
considerably higher than these estimates for semi routine testing.  As  the test
comes into routine use,  however, costs could decline sharply because of  sim-
plified and standardized methods (disregarding inflation).
           Data generated in  any one of the assays described  in  this  report
would be analyzed by  routine statistical methods (e.g.,  variance analysis).

Assays from Woodard (1976)

          In the report by Woodard (1976)  to OPTS/EPA, potential physiological
toxicity assays for  studies on chemicals  were  reviewed  under four categories:

-------
                                      12

 (1) use of fertilized eggs, (2) use of isolated organs and tissues, (3) use of
 mammalian and  avian  cell  cultures,  and (4) use of  bacteria,  fungi,  protozoa,
 and  plant cells.   In the  following  paragraphs,  we  consider in  vitro  tests
 derived from each of Woodard's test groupings.
          The  literature on the use of fertilized eggs in studies on chemicals
 focuses almost exclusively  on the  development  and  use  of  fertilized  chicken
 eggs  as  a toxicity bioassay.   The production of abnormalities  in the devel-
 oping  embryo  as  a result of the  administration  of  thallium was  first demon-
 strated  by  Karnofsky  in  1950 using  the  fertile chicken  egg.    However,  the
 chick  embryo  development assay  requires  a  long  period of  time  to  complete
 (1  month),  calls  for expensive  specialized  equipment, and  does not have  a
 universally  standardized end  point  such  as  embryo  death  or  abnormal  limb
 development  (Table  16).   In  general,  the use of fertilized  chicken  eggs  has
 enjoyed some  attention  in  studies on the teratogenic  potential  of chemicals,
 but this  method  is still regarded  by  toxicologists  as  only marginally useful
 in screening for other types of toxic effects.
          Toxicity tests have also  been conducted using two types of inverte-
 brate  eggs  as test  subjects.   However,  few  data  exist concerning  chemical
 effects on hatching of brine  shrimp or on the early development of sea urchin
 embryos, and a tremendous amount  of developmental research  would  be needed to
 adapt these assays for routine toxicity testing.   As for present data on these
 two test systems, the inhibitory  or stimulatory effects  on  hatching or devel-
 opment  apparently do  not  correlate  with  the carcinogenic  effects of  known
 chemical compounds tested (Woodard, 1976).  So these assays are apparently not
 immediately useful as potential  toxicity screens.
            Woodard's  category on  the use of  isolated  organs and  tissues  in
 studies on  chemicals  was reviewed.   The  advantages  and limitations  of  these
 bioassay systems are discussed on page 2 in relationship to Table 1.
           Several rapid, potential toxicity  assays  using  mammalian cell cul-
ture,  bacterial,  protozoan,  and plant  test systems  are critiqued later in this
 report.
            Cytotoxicity  assays  employing mammalian  cells  in culture  measure
quantitatively cellular  and metabolic  impairment  or death  resulting  from in
 vitro  exposure to soluble and particulate toxicants.   Mammalian cells  derived

-------
                                     13
from  various  tissues  and  organs  can  be  maintained  as  short-term  primary
cultures or,  in some cases,  as  continuous  cell  strains or  lines.    Primary
cultures  exhibit  many  of  the  metabolic  and  functional  attributes  of  the
original tissue.  Some of these attributes may be lost after  a  prolonged  time
in culture.
          There  are certain requirements basic to any assay that  requires  the
use of mammalian cells in vitro.   Paramount among these  are aseptic facilities
for the  propagation and  handling  of cultured  cells  and qualified  personnel
trained in safe and proper cell  culture technique.
         There are many advantages in using  mammalian cell  culture systems in
toxicity assays.   First,  they are  generally more rapid and  less  costly  than
whole  animal  tests.   Second,  a lesser  quantity  of  potential  toxicant  is
required for these  in vitro tests.   Third,  specific physiological  or biochem-
ical  alterations  are  more  easily   evaluated  in  cell   culture  systems,  and
fourth,  the  systems  provide  useful  information  about  the relative  cellular
toxicity of unknown samples (Woodard, 1976).
         Cell culture toxicity screens  also have several  drawbacks.  Since the
assays  employ  isolated  cells  and not  intact animals,  they  can  provide  only
preliminary  information about the ultimate  health  hazards  of  toxic chemicals.
In many instances, some metabolic action in an animal  renders  a chemical toxic
or  nontoxic.   So,  a  chemical  which appears  toxic  at  the cellular  level  may
actually  be  innocuous at the tissue  or  higher level   because  of  metabolic
deactivation.   Likewise,  a  toxic  chemical  could appear  nontoxic at the cellu-
lar level since metabolic activation of a chemical to a  toxic form could occur
in vivo but might not occur in cell  culture.
           Another disadvantage is that  cell  culture test systems may become
contaminated with  latent  viruses or Mycoplasma  sp., which  can alter cellular
metabolism.  Also,  media  constituents  (such as  calf serum) must  be carefully
monitored  and  controlled  since  they may  affect cellular metabolism  or  form
complexes with the test chemical (Woodard, 1976).
             Both  neoplastic (tumor-derived) and  nonneoplastic (primary)  cell
lines  are  utilized  in assays described  in  this report.   Although neoplastic
cells  are abnormal  and  have  probably  lost some  metabolic  capabilities as
compared with primary cultures, they respond equally well in many  cytotoxicity

-------
                                      14

assays.  Neoplastic cells are generally used because they grow rapidly and are
more readily propagated than primary cultures.  The only neoplastic cell  lines
used  include  human HeLa  and KB.   Nonneoplastic cell  lines  utilized include
human WI-38,  rabbit  alveolar macrophages, mouse L929,  and  mouse  lymphocytes.
Other mammalian cell types can be used as alternatives to these cell lines.
          Several  of the cell culture  assays  described  here could be combined
to form one assay which could assess several parameters.  This would provide a
more cost-effective means  for  using cell culture systems  for screening  toxic
chemicals.
         As described by Woodard  (1976),  the  use of nonmammalian  cell systems
in toxicity testing is now well  established.  The potential for bacteria, pro-
tozoan, and plant systems in physiological  assays is  also  great.   Most assays
involving  these  systems  are more  rapid  and less  expensive than  mammalian
systems.   Also,  many potential   toxicants can generally be screened simulta-
neously,  and  often  only  unskilled technicians  are  required to  perform the
test.
           A drawback to the use  of plant,  bacteria,  and protozoan systems  in
toxicity screens  is the questionable extrapolation of data obtained from these
systems to  mammals.   The converse  is  also true in that mammalian systems  as
toxicity screens  cannot always be extrapolated to  plant or microbial systems.
Although all cells  have certain  structural and metabolic properties in common,
certain processes which only occur in  whole  animals  or plants  (e.g., uptake
and transportation  of potential  toxicants) still  are not fully understood.

-------
                                     15

                        DISCUSSION  AND  RECOMMENDATIONS
          The objective of this report  was  to  identify  potential  physiological
toxicity tests in the  literature  and  to assess each on  the  basis of several
criteria.   Even though  each  assay  has advantages and  disadvantages,  it  is
difficult to rank them on the basis of a literature review alone.  Before  any
final decision on the  utility  of  any assay is made, laboratory  evaluation is
necessary.  However, on the basis  of the literature review, it is possible to
approximate the degree of laboratory development needed  to adapt  and  validate
these protocols as  routine toxicity screens.
         We have identified three  levels of assay development:  those  requiring
minimal   development,  those  requiring  some development,  and  those  requiring
significant development.  Assays are placed in one  of  these  categories  on  the
basis of the criteria listed in Tables  28 through 32.
         Assays  that  would  require little development  for  use as  toxicity
assays (i.e., immediate validation) include greening, hemolysis,  human KB cell
growth rate, phagocytosis by alveolar macrophages,  macroinolecular synthesis in
human KB  cells,  RNA polymerase activity, and  human embryonic  lung  fibroblast
(WI-38)  cytotoxicity.   Assays  that would require some development  for  use as
toxicity assays include acetylene  reduction, the  Hill reaction, RuDP carboxyl-
ase  activity,  adenylate  energy  charge, chick  embryo  development,  protozoan
clonal viability, cloning L929 mouse cells, trypan  blue dye exclusion by human
KB  cells,  protozoan motility,  and amino  acid transport.   Assays  that would
require extensive development include cyclosis, protozoan vacuole contraction,
photosynthetic oxygen  evolution,  respiration  in HeLa  cells,  mitogen stimula-
tion of lymphocytes, lysosomal  enzyme release, and  adenyl cyclase activity.
          Some assays naturally drop from consideration.   These tests meet  few
(or  none)  of the criteria  used  for  assay evaluation  (simplicity,  rapidity,
cost  effectiveness,  documentation,  reproducibility,  etc.).    For  example,
cyclosis  is  one  of the  most expensive and time-consuming  assays.    It has a
poor  data  base,  and  results are probably  not  ecologically  significant.
Protozoan  vacuole contraction, photosynthetic oxygen  evolution,  and respira-
tion  in  HeLa cells require  extensive  development  and have  been rejected  for
immediate use because several of the criteria  are not optimum.  Adenyl cyclase

-------
                                      16
 activity,  mitogen  stimulation  of lymphocytes,  and lysosomal  enzyme  release
 have  poor  data  bases  with  regard to  toxic chemical effects.   In  addition,  it
 appears  difficult  to  relate results from  adenyl  cyclase activity to cellular
 or  tissue  toxicity.  Mitogen stimulation  of  lymphocytes requires maintenance
 of  an expensive mouse colony.
         Those assays in the  second  category  (some development) are more dif-
 ficult  to  evaluate since  their  advantages  and  limitations  are  more  equally
 balanced.   In some  assays  (Hill  reaction,  chick  embryo development) very good
 data  bases  on toxic chemical  effects  exist.   However, there are GLP problems
 with  the Hill  reaction  since chloroplast  activity may  vary.    Chick  embryo
 development  requires  a  long  time  to  complete  and lacks  a  standardized end
 point.   RuDP carboxylase activity has  a  poor  data base and GLP problems, even
 though  it  is  rapid  and  inexpensive.   Protozoan motility is time consuming and
 expensive,  but  automation  could make  test  results  easier  to  obtain.    The
 clonal  assays  (cloning  L929 mouse cells and  protozoan clonal viability) both
 have  good  data  bases  and are simple.   However,  each  requires  a  long  time  to
 complete.
         The membrane assays (amino acid transport, trypan blue dye exclusion)
 were  not considered easily developed assays because they have poor data bases.
 Development of these assays should be  considered because tests results can  be
 extrapolated  to  all membranes.   Even  though  acetylene reduction  monitors  a
 vital  physiological  and ecological  process,  the  current  assay  method  needs
 streamlining (e.g., use of a multisample gas chromatograph).
         The remaining assays are rapid, simple, reproducible, cost-effective,
 and well documented.  In many  cases,  it is advisable  to combine several  tests
 (or give a  single  test  multiple  end points)  and to correlate  the  results  to
 give  the responses  to  chemicals broader  ecological  or  biological  meaning.
Greening, Hill  reaction,  chlorophyll   fluorescence,  and  a  growth  test (e.g.,
 seedling  growth)  could  possibly be  combined to give  a  good  indication  of
 phytotoxicity if the same organism were used in all assays (Kratky and Warren,
 1971).
           It also  would  be possible  to  combine RNA  polymerase  activity and
macromolecular synthesis  in human KB  cells  to detect chemical  inhibition  of
RNA synthesis.  Phagocytosis by  alveolar  macrophages  and amino acid transport

-------
                                     17
(and/or trypan  blue dye  exclusion  by human  KB  cells) could  be combined  to
detect inhibition of mammalian membrane function.
           Hemolysis appears to be  one of the best potential  toxicity  assays
because it  is  cost-effective and can  be  performed by unskilled  technicians.
Also, the  lysis  of  erythrocytes  is  a  generally accepted  standard of  toxicity
because mammalian  tissues depend on  hemoglobin  for  transport  of  gases  and
nutrients.  Human KB  cell  growth  rate and  human  embryonic  lung  fibroblast
(WI-38) cytotoxicity  also should require  little  development  since they  are
already used as toxicity assays by the National  Cancer Institute.  Since these
assays are  well  documented,  simple, and  inexpensive,  they could probably  be
quickly validated as toxicity screens,  with implementation following.

Comments
          In evaluating  and  ranking  these  24  potential  physiological  toxicity
test methods, there are several points that merit consideration.
         Physiological test methodologies have proved very useful  for studying
mechanisms of toxic  action  and for  evaluating  large numbers of  toxic  chemi-
cals.   Physiological tests  (predominately  in vitro) have  several  advantages
over  in  vivo methods  (e.g.,  time,  cost,  and quantisation  of results),  but
results from physiological tests can at best give preliminary information on a
chemical's toxicity.  As described on page 13, an in vivo system may mediate a
chemical's toxic activity by metabolic  activation  or deactivation.   This can-
not occur in in  vitro systems.   Hence,  physiological  methodologies  could give
false positive or negative results.
         Results obtained from cellular, organellar, or enzymatic test systems
cannot  usually  be   extrapolated  to  ecosystem   effects  for  several  reasons.
First, only one physiological parameter of a single test organism is monitored
in each assay.   These assays are by no means an intensified ecological study,
and  no  direct  extrapolations  from  these tests  could  effectively be  made to
ecosystem effects.   Second, test  organisms  such as mammalian  cells or algae
are  genetically  homogeneous because  these test  cells  are  clonally derived.
Since cells and tissue systems differ greatly in whole animals, these cellular
systems  are  usually  not good  indicators  of in  vivo  responses.    Third,  a

-------
                                      18

selected  test  organism may be  unusually  sensitive or insensitive to  certain
chemicals  and   give  inconclusive  (or  false)   results.    Physiological   test
systems,  both  mammalian  and  nonmammalian,  could be effectively used as  toxi-
city screens to identify the need (or lack of need) for further testing.
          Information  obtained  from  one  cellular  physiological  test  can  often
be  extrapolated to  a  more complex  multicellular system  because of  certain
structural and  functional  similarities.   All cells are  enclosed  by  virtually
identical semipermeable membranes, contain DNA,  and respire.   It is  not usual-
ly safe to extrapolate beyond this, however.
          In summary,  since most  previous  toxicity test methods  have  been  in
vivo, the effectiveness of cellular  or  subcellular test  methods has  yet  to  be
demonstrated.  The in  vitro test methods have several  advantages  over  in vivo
ones (e.g.,  time  and cost),  but they still  have  certain practical  and scien-
tific limitations involving correlation of toxic  effects  on  cellular metabol-
ism to toxic effects in ecological  systems.

-------
                                     19
      POTENTIAL TOXICITY ASSAYS—DESCRIPTIONS,  METHODS,  AND  ASSESSMENTS


NITROGEN FIXATION

Acetylene Reduction

            The conversion of  atmospheric  nitrogen  into organic  compounds  by
living organisms is called nitrogen fixation.  This process  is  carried  out  by
microorganisms,  including the free-living  bacteria,   blue-green  algae,  and
bacteria associated  in  a symbiotic condition  with  plant roots.   The  enzyme
nitrogenase catalyzes the transfer of electrons from an electron source to ni-
trogen, resulting finally in the production  of ammonium ions.   The acetylene-
ethyl ene assay for  nitrogen  fixation  is  based  on the nitrogenase-catalyzed
reduction of  acetylene  to ethylene.   Ethylene concentration  is  determined  by
using a gas chromatograph equipped with a hydrogen-flame analyzer.
         This  assay  involves incubation  of bacteria with an energy source and
reductant in  a flask sealed with a serum cap.   After repeated flushing with a
source of acetylene, the  bacteria  are added  aseptically through  the  cap.   The
reaction mixture  is  incubated  on a rotary shaker at 30 C for 30 minutes, and
the incubation  is stopped by addition of 0.5 ml  6N  sulfuric acid.   Samples of
the  gas  phase  are  then  measured  with  a hydrogen2-flame ionization detector
after gas chromatographic separation.
           As  described  by Hardy et  al  (1968), the  complete assay system con-
tains 4  ml  liquid volume and  36 ml  gas volume.   The  liquid reaction mixture
includes 50  mM Tris-HCl, 56 mM  creatine phosphate, 5  mM ATP,  5 mM magnesium
chloride, 20  mM disodium thiosulfate, 0.2  mg of  creatine kinase,  and 4 mg of
heated extract of  ammonia-grown  _A.  vinelandii.   The gas phase of  the reaction
mixture  contains 0.1 atmosphere  of acetylene and  0.9 atmosphere of helium.
Chemicals to  be tested  are  added  to the  reaction  vessels  at various concen-
trations.   Inhibition  of acetylene reduction,  expressed  as a  percentage of
control  values,  can  be  calculated  for the various levels of  a test chemical.

-------
                                       20
           Monitoring  the  effects of toxic chemicals on  nitrogen  fixation  is
 important because captured atmospheric nitrogen is converted into amino acids,
 the building blocks of all proteins.
         Details on acetylene reduction are summarized in Table 4.

 PHOTOSYNTHESIS

 Hill Reaction

            Robin Hill  discovered  that  light-induced oxygen evolution  can  be
 observed  in  cell-free granular  preparations  (chloroplasts)  extracted  from
 green  leaves.   Illumination  of such chloroplast  preparations  in the  presence
 of  artificial  electron  acceptors,  such  as  ferricyanide  or  reducible  dyes,
 causes  evolution  of  oxygen  and  simultaneous  reduction  of  the  electron
 acceptor, according to the general equation
                          H20 + Ah+ AH2 +  1/2 02

 where A  is  the  electron  acceptor  and AH2  is  its  reduced  form.    In  a  photo-
 synthesizing plant, A  is nicotinamide adenine  dinucleotide  phosphate (NADP).
 NADP accepts  the electrons,  and  the reduced  form of NADP  is  used to  reduce
 carbon dioxide  into sugars.    Hov/ever,  in  the  in vitro Hill  assay described
 below, dyes  are  used  to accept  the electrons  liberated  from  water.    As  the
 dyes are reduced, they change color and this color change is quantitated.
         For the Hill  assay,  chloroplasts are  isolated from plants  grov/n under
 controlled conditions  or from batch cultures of Euglena  or Chlorella.   Accord-
 ing to the chloroplast  isolation method of  Wald et al (1966),  algae or leaves
 are homogenized with 0.5 M sucrose solution at  0  C for  30 seconds  in a Waring
 Blendor.   The suspension is then  filtered  through  tv/o layers  of cheese cloth.
The filtrate is  centrifuged  at  50 g for 10 minutes.  The supernatant is  then
decanted and centrifuged for  10 minutes  at 600 g.   The supernatant  is decanted
and discarded.   The  pellet  at  the bottom,  containing the chloroplasts,  is
suspended in 0.5 M sucrose.  It  is important  to keep the chloroplasts  at  0 C
because they deteriorate rapidly at higher temperatures.
         It  is  advisable to examine the chloroplast preparation under a micro-
scope  to ensure that the chloroplasts are of uniform size, intact,  and free of
other  cellular debris.

-------
                                    21
                       TABLE  4.   ACETYLENE  REDUCTION
      Criteria
           Critique/Comments
Test Organisms


Advantages
Limitations
Response to Chemicals
Assay Time, hours

Special Equipment


Cost §

References
Either Azotobacter vinelandii  or
  Clostridium pasteurianum may be used.

The analytical  method can detect as little
  as 1 picomole of ethylene.
The tests organisms are simple to culture.
The assay may be utilized in  either the
  field or laboratory.
The phase of the potential  toxicant may
  be solid, liquid, or gas.
A short time is required to obtain
  the results of this assay.

Acetylene is a very explosive gas and
  requires care in handling.
Nonnitrogenase catalysis of the reduction
  may occur.
Specialized equipment is needed.
The assay and gas chromatography must be
  performed by skilled technicians.

Chlorinated aliphatics [trichloroacetic
  acid, ethylene glycol bis(trichloroacetate)]
Arsenicals (cacodylic acid, disodium
  methanearsonate)
Metabolic inhibitors (2,4-dinitrophenol)
Gases (carbon monoxide-I^gg is 0.18 atm)

2.5*, 54**, 12t, 8t

Gas chromatograph with a hydrogen-flame
  analyzer

$620

Hardy et al, 1968
Rubinstein, et al, 1975
 *Time for one assay set—three replicates of each of five concentrations
  of ore chemical.
**Total assay set time, including cell growth, solution preparation, and
  data recording.
t Total technician time, including GLP, performing assay, and solution
  preparation.
t Administrative time (Management, Ph.D. supervision, data analysis, and
  reporting).
§ Estimated cost for comparative purposes.  Actual costs may differ 20 to
  25 percent (see p. 11).

-------
                                      22
            The Hill  reaction  assay  mixture contains 2 ml of  0.1  M phosphate
 buffer  (pH  6.5),  2  ml  of  2.5  x  10-4  M  dichlorophenolindophenol,  0.1  of
 chloroplast  suspension, 1 ml of toxicant or chemical to be tested,  and 5 ml  of
 distilled  water.   Chemicals  to be tested  are incubated with  the  chloroplast
 suspension prior to  addition  of  the  electron acceptor.   Each reaction mixture
 is then exposed to the  same  bright light for 10 minutes.   Over  the course  of
 the  10 minutes, the  absorbance of the dye is monitored at 620 nm (Wald et al,
 1966).  The  effect of a potential  toxicant  on the  rate of this photosynthetic
 reaction  is  reflected by  the  rate at  which  the  dye is  reduced and turns from
 blue to clear.
         Details on the Hill reaction are summarized in Table 5.

 Greening

          Potential toxicants  alter  plants' chlorophyll content by a number of
 mechanisms.   Chlorophyll biosynthesis  is  affected  by specific  chemical  stimu-
 lation or  inhibition of DNA, RNA, or protein  synthesis.  Some chemicals affect
 chloroplast  development  or  structure,  resulting  in  an  altered  chlorophyll
 content.   Other chemicals degrade or induce the degradation of the chlorophyll
 molecule (Wolf, 1977).
            To measure the  effect of a  chemical on chlorophyll accumulation,
 dark-grown plants are  subjected  to a series  of  chemical  concentrations prior
 to greening.   In  detail,  etiolated  barley  plants  7  to  9  days  old  are sprayed
 (misted)  with solutions of a  chemical.   The spray  is directed  at  the coleop-
 tiles (or  hypocotyl  hooks)  from above.  For every 200  seedlings,  about 50  ml
 of solution is used.   Alternatively,  seedlings could be grown  in soil amended
 with toxicant.  The seedlings  are transferred to an  irradiation chamber 1 hour
 after being treated.   The plants are irradiated for 24 hours  by white fluores-
 cent lamps  at an  intensity of 1000  ftc.   Except  during  white-light irradia-
 tion, plant material  is handled in dim green light (Margulies,  1962).
          Chlorophyll is extracted from 2-g leaf samples by heating in boiling
 water for 30  seconds, and then by grinding  in a Virtis-type homogenizer with
80 percent acetone.  The macerate is centrifuged,  and the chlorophyll content
 of the resulting supernatant  is  measured spectrophotometrically at 663, 645,

-------
                                    23
                            TABLE 5.   HILL  REACTION
     Criteria
        Critique/Comments
Test Organisms
Advantages
Limitations
Response to Chemicals
Assay Time,* hours

Special Equipment


Cost*

References
                  oleracea),  Chlorella,
Spinach (Spinacia
  Euglena
The test organisms are simple to grow or are
  readily available.
A short time is required to obtain the
  results of this assay.
The assay is capable of detecting very
  minute quantities of potential toxicants.
The assay can be performed by unskilled
  technicians.

Chloroplast activity varies among
  preparations and declines with age.
Reducing or oxidizing agents may interfere
  with and produce variation in the assay.

Antibiotics (chloramphenicol-Igg is
  4 mg/ml)
Ureas (3-cyclooctyl-l,1-dimethylurea,
  l-(2-methylcyclohexyl)-3-phenylurea)
Herbicides (2-chloro-4,6-bis(isopropylamino)-
  s-triasine, 2-methoxy-4,6-bis(ethylamino)-
  s-triazine)
Inorganic salts (ammonium chloride)
Inorganic ions-heavy metals (cadmium, zinc)

3, 57, 18, 11

Spectrophotometer (Beckman Spec 20)
  or colorimeter

$820

Hill, 1937
Margulies, 1962
Morel and and Hill, 1962
Anderson and Boardman,  1964
Wald et al, 1966
Brown and Haselkorn, 1972
Hamp et al, 1975
Rubinstein et al, 1975
*See time and cost explanation, pp. 9-11 in text.

-------
                                       24

 and  626  nm by the method  of  Anderson  and  Boardman  (1964).   This method takes
 into account the absorbance of protochlorophyll , the precursor of chlorophyll,
 as well  as chlorophylls a and b.   The following equations  can then be solved
 to give the individual pigment concentrations in yg/ml:

                  C  = 12.67E663  -   2.65E6«  -  0.29E626
                   a
                  Cb  = -4.23E663  +  23.60Es«  -  O.SSEsas
                   P  = -3.99Es63  -   6.76E6«  +  29.60Es26 -
          This  bioassay  is  especially  sensitive to photosynthetic and respira-
tory inhibitors, but results do not usually correlate with results from growth
Assays  (Kratky and Warren, 1971).
         Details on the greening assay are summarized in Table 6.

RuDP Carboxylase Activity

           Ribulose-l,5-diphosphate  carboxylase (RuDPCase)  is a soluble enzyme
localized in the chloroplast stroma of vascular plants.   This enzyme catalyzes
the primary fixation of carbon  dioxide  during photosynthesis in some monocots
and in most dicots.
         This assay employs cell-free extracts of leaves or algae.  Leaves are
obtained from  spinach  plants  grown  under controlled conditions  and  the algae
Euglena and Chlamydomonas are easily grown in batch cultures.  As described in
the greening assay, test organisms  are  exposed to a chemical  prior  to isola-
tion and determination of RuDPCase.   Alternatively, chemicals to be tested can
be incubated with the enzyme  preparation  prior to additon of  the other reac-
tion reagents (see below).
            To  prepare  an  extract,  as  described  by Goldthwaite  and Bogorad
(1971), 1 g of leaves or algae  is  ground in a small Waring Blendor for 2 min-
utes in  2  ml  of an  ice-cold  buffer containing  0.2 M sodium  bicarbonate (pH
8.0),  1  percent  polyvinyl  pyrrol idone,  and 1  mM  dithiothreitol.   The homoge-
nate is filtered through cheesecloth and  Miracloth  and  then  is centrifuged at
35,000  g  for  15 minutes  at 4  C.   The  resulting supernatant  is  assayed for
enzymatic activity.

-------
                                    25

                            TABLE 6.  GREENING
     Criteria
           Critique/Comments
Test Organisms
Advantages
Limitations
Response to Chemicals
Assay Time,* hours

Special Equipment

Cost*

References
Barley seedlings (Hordeum vulgare)  are
  the major test organism.
Pinto beans (Phaseolus yulgaris)  and jack  beans
  (Canavalia ensiformis)  may also be used.

The test is capable of identifying many
  different chemicals as  potential  toxicants.
A relatively short time is  required to obtain  the
  results (chlorophyll determinations) of  this assay.
The test organisms are simple to  grow.
There is a direct relationship between the
  concentration of the chemicals  investigated
  and percentage of chlorophyll inhibition.
The assay can be performed  by unskilled technicians.

Specialized equipment is  needed.
The total time, including greening and chlorophyll
  determinations, is lengthly.

Antibiotics (streptomycin,  chloramphenicol)
Nucleic acid analogues (5-fluorouracil,
  Z-thiouracil-Igy is 5 mM)
Amino acid analogues (ethionine,  p-fluorophenylalanine)
Plant hormones (2,4-dichlorophenoxy acetic
  acid, naphthalene acetic  acid,  abscisic  acid)
Herbicides (amino triazole, paraquat, atrazine)
Growth retardants (coumarin, N,N-dimethylamino
  succinamic acid)
Ureas [diphenylurea, 3-(4-chlorophenyl)-
  l-(l-dimethylurea)]
Fungal metabolites (alternaric acid, tentoxin)
Alcohols (ethanql-Iigo is 100%)
                        nickel, lead, and aluminum ions)
                       10 mM, fructose, glucose)
                       carbon monoxide, methane,
                        Inorganic ions (cobalt.
                        Sugars (sucrose-Igg is
                        Gases (carbon dioxide,
                          ethylene)
29, 150, 9, 8

Spectrophotometer or colorimeter growth chamber

$560

Arnon, 1949
Margulies, 1962
Anderson and Boardman, 1969
Keller and Huffaker, 1967
Kratky and Warren, 1971
Rubinstein et al, 1975
Borque et al, 1976
Wolf, 1977
*See time and cost explanation, pp. 9-11 in text.

-------
                                      26
          RuDPCase activity is measured by incorporation of radioactive sodium
bicarbonate   (NaH^cc^)   into  acid-stable  products   in   the   presence   of
ribulose  1,5-diphosphate  (RuDP).   A 25-yl  aliquot of enzyme  is  mixed  on  the
surface of a planchet with 100 yl  of reaction mixture containing the following
(all  are  final  concentrations):   100  mM Tris-HCl  (pH  8.0);  50 mM  NaHl4co3
(sp. act. 0.20 yCi/ymole); 0.3 mM RuDP; 10 mM magnesium chloride;  6  mM reduced
gluthathione;  0.1  mM  ethylenediaminetetraacetic  acid.  After 10  minutes  at
room temperature, the reaction is  stopped by addition of 6  N acetic  acid.   The
planchets are dried and counted in a gas-flow counter.  The reaction is linear
with  enzyme  concentration until  30  to 50  percent of the  RuDP  is  consumed.
Incorporation in the absence  of RuDP  is Tess than 2 to 3 percent of that  when
PuDP is added.
         Details on this assay are summarized in Table 7.

Photosynthetic Oxygen Evolution

             In  the presence  of sunlight,  algae and .terrestrial  green plants
photosynthesize and thus  convert  carbon dioxide and  water  into carbohydrates
and oxygen  (02).  Even  though 02  evolution is  used as a measure  of photo-
synthesis, the  02  evolved from a  plant cell is  equal  to  the  02 released  by
photosynthesis  minus  the 02  consumed  by  respiration.   The  assay  described
here  is based  on comparing the  rates  of 02  evolution from algal  cells  pre-
incubated with  a test  chemical to the rate of 02  evolution from algal  cells
not treated with the test chemical.
             The green, unicellular  alga  Scenedesmus  is used   in this assay.
Scenedesmus  obliquus,  strain  03,  is grown  in  a  glucose-yeast  extract medium
until  a  packed cell  volume of about  10  yl/ml  is  obtained.   About 40 ml  of
cells  are collected and washed in 0.05  M  potassium phosphate buffer (pH 6.5).
The washed cells  are incubated in  a buffer containing  concentrations  of the
test chemical.   Following exposure to the test chemical, cells  are washed  free
of the  chemical  by suspension  and  centrifugation.   Then,  2  ml  of  the algal
suspension is added to  each  of two Warburg flasks and 0.5 ml of p-benzoquinone
is added  to  each side  arm to inhibit  respiration.  Also,  diuron is  added to
the side arm of the first flask (control)  to inhibit photosynthesis, and water

-------
                                  27
                  TABLE 7.  RUDP CARBOXYLASE ACTIVITY
     Criteria
      Critique/Comments
Test Organisms
Advantages
Limitations
Response to Chemicals
Assay time,* hours

Special Equipment

Cost*

References
Spinach (Spinacia oleracea),
  Euglena, Chlamydomonas

The test organisms are easy to grow or
  obtain.
A short time is required to obtain
  the results of this assay.
There is usually a direct relationship
  between  the concentration of the
  chemicals investigated and percent of
  enzyme inhibition.

The enzymatic activity varies among
  preparations and declines with storage.
The growth conditions of the plants
  dramatically affect enzymatic activity.
Some specialized equipment is needed.
The assay  is performed by highly skilled
  technicians.

Antibiotics (cycloheximide-Iioo 1S
  0.01 mg/ml; puromycin, streptomycin)
Herbicides (paraquat)
Growth regulators (N-(dimethylamino)
  succinamic acid)
Arsenicals (cacodylic acid)

2, 54, 12, 8

Gas flow counter or scintillation counter

$750

Keller and Huffaker, 1967
Goldthwaite and Bogorad, 1971
Rubinstein et al, 1975
*See time and cost explanation, pp. 9-11 in text.

-------
                                       28

 i'S  added  to  the  side arm of the second flask.  The flasks are equilibrated in
 the water bath of a Warburg apparatus at 25 C for 20 minutes.  The contents of
 the side arms of the two flasks are then tipped into the bottom of the flasks,
 and immediately the  measurement  of 03 evolution with high  light  intensity is
 started.
         In the Warburg  apparatus,  volume  changes  are  measured in an enclosed
 atmosphere in direct  contact  with  the liquid under conditions in which oxygen
 is  the  only  substance undergoing  a net  transfer  between  the liquid  and  gas
 phases.
         Results from this manometric measurement are expressed as the percent
 of  inhibition  of 02 evolution  as  a  function  of  test  chemical concentration.
 An oxygen electrode can be used instead of the Warburg apparatus.
         Details on this assay are summarized in Table 8.

 RESPIRATION

 Respiration in HeLa Cells

           Mitochondria are present  in  virtually all living  cells.   Both  the
 Krebs (tricarboxylic acid) cycle and electron transport systems, the final  two
 stages  of  cellular respiration, occur  in the  mitochondria.   In  these  final
 stages, oxygen is consumed, and carbon dioxide and water are evolved.  The  net
 equation for cellular respiration is:
                    CCH,,,0C +  60,, -> 6CO, +  6H00  +  energy.
                     O  I i. 0     C.      <-      c.
           To measure cellular respiration,  it  is possible  to  monitor either
 consumption of  oxygen or  evolution of carbon  dioxide.   In  this  assay,  HeLa
 (human) cells are  grown  in Eagle's medium to  a density of 4  x  10^ cells/ml.
 Other mammalian  cell  types can be  used, but it is not  feasible  to use  algal
 cells  which  both photosynthesize  and respire.    The  cells  and   a  potential
 toxicant are placed  in  the test chamber of  a precalibrated oxygen electrode,
which  can  be purchased  from  a  commercial  source  or  made  as  described  in
Bruening  et  al  (1970).     The  dissolved  oxygen  is  monitored  at  10  minute
 intervals  for 1  hour.  A  graph of dissolved oxygen versus time is plotted,  and
the slope  of  the plot represents the rate of oxygen consumption.

-------
                                  29
               TABLE 8.   PHOTOSYNTHETIC  OXYGEN  EVOLUTION
     Criteria
      Critique/Comments
Test Organism

Advantages



Limitations
Response to Chemicals


Assay Time,* hours

Special Equipment

Cost*

References
Scenedesmus obliquus,  strain D^

The test organism is simple to culture.
Oxygen electrode can be used in place of
  the Warburg apparatus.

Specialized equipment  is  needed.
A great deal of time is required to
  equilibrate flasks and  accurately
  determine gas exchange  rates.
This assay must be performed by skilled
  technicians.
Variation in respiratory  and photosynthetic
  Og evolution make interpretation of
  results difficult.

Herbicides (l,l-dimethyl-3-pheny1urea,
  3-(p-chlorophenyl)-l,l-dimethylurea)

50, 100, 84, 11

Warburg manometric apparatus

$2330

Pratt and Bishop, 1968
Rubinstein et al, 1975
     time and cost explanation, pp. 9-11 in text.

-------
                                        30

          To  note  the  effect  of  a  potential  toxicant, a  different concentration
 of the test  chemical  is  added to  a  chamber of  fresh HeLa  cells,  and again
 dissolved oxygen  is monitored  at  specific time  intervals.  This is carried out
 at several  different  chemical  concentrations,  and a graph is plotted for each
 concentration.    Inhibition  or  stimulation of  respiration  is  determined  by
 comparing the rates of oxygen consumption for the test  chemicals with those of
 the standard.
          Toxic  chemicals  that  inhibit respiration would most certainly influ-
 ence the metabolism  and  viability of  the  organism since  respiration  is  the
 process  by which  aerobic  cells  obtain energy  from the  oxidation of fuel mole-
 cules  by  molecular oxygen.
          Details  on this  assay are  summarized in Table  9.

 HIGH-ENERGY PHOSPHATE PRODUCTION

 Adenylate Energy  Charge

           Even  though the production of  adenosine-51  triphosphate  (ATP)  is a
 common  goal  of  both  anaerobic and  aerobic  metabolic  activities,  the measure-
 ment of ATP alone may not be an accurate index of  both biomass and metabolic
 activity.   The  total  energy  level  of the cell is  dependent upon  the balance
 between  the   adenosine phosphates.    ATP contains  two  high-energy  anhydride
 bonds,  ADP contains  one, and  AMP  none.   Atkinson  (1969)  and Atkinson  and
 Walton  (1967)  proposed  an  adenylate energy  charge  (AEC)  as a  fundamental
 metabolic control parameter:

                           acr  _ ATP + 1/2 ADP
                           tL    AMP + ADP + ATP

The  expression  is  a  measure  of  the  anhydride-bound  phosphate  groups  per
adenine moiety and is  written so that the parameter will range in value from 0
to  1.   In general, when  the AEC > 0.5,  ATP-utilizing systems  increase their
activities; AEC  < 0.5, ATP-regenerating sequence dominates  (Atkinson,  1969;
Ching et  al,  1974).   In   this  assay,  cells  are  incubated with various concen-
trations  of a toxicant,  and  the  adenosine  phosphates   are then  isolated  from

-------
                                  31
                  TABLE 9.   RESPIRATION IN  HELA CELLS
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals



Assay Time*, hours

Special Equipment


Cost*

References
HeLa (human) cells

The test results are straightforward
  and easily obtainable.
The test organism is easy to grow.
The assay shows the effect of
  chemicals on a major metabolic
  pathway, respiration.

This assay must be performed by
  skilled technicians.
Only one chemical at one concentration
  can be tested at a time.
Some special equipment is required.
Reducing or oxidizing agents may inter-
  fere with and produce variation in
  this assay.

Metabolic inhibitors (malonate)
Detergents (Triton X-100, sodium
  deoxycholate)

30, 80, 51, 13

Oxygen electrode, mammalian cell
  culture facilities

$2350

Bruening et al, 1970
*See time and cost explanation, pp. 9-11 in text.

-------
                                      32

the cells  and  quantitated.   This  assay  can be applied to  bacterial,  fungal,
algal, mammalian, and  plant  cells  or to  mixed cultures and microbial  assem-
blages.  However, for  development  as an  in  vitro toxicity  assay,  the  rapidly
growing bacterium Escherichia coli, the green  alga Euglena, or the human  cell
line HeLa are excellent cellular candidates.
         In this assay, a known number of cells are  incubated  at  37 C  for  1  to
2 hours with a  toxicant.   Adenosine  phosphates are then extracted from cells
with chloroform (Bostick and Ausmus,  1978;  Nannipieri et al,  1978). Quantita-
tion  of  ATP is  based   on  reactions  with  hexokinase  and  glucose-6-phosphate
dehydrogenase.    In  these enzymatic  reactions, ATP causes  the production  of
reduced nicotinamide adenine dinucleotide (NADH).   NADH  can  then  be  quanti-
tated fluorometrically  down  to 10~12 M.   For determining  AMP  and ADP,  ade-
nylate kinase and  pyruvate  kinase  are  added to the mixture to  convert these
two adenosine phosphates to  ATP.  This ATP  is  then measured using  the  hexoki-
nase  method  described   above  (Bostick and  Ausmus,  1978).   A ready-made ATP
determination kit is commercially  available from Calbiochem.   Comparison  of
calculated AEC per  cell  values allows conclusions  to be drawn on  the  physio-
logical  status  of cell  populations  exposed to toxicant.
         Details on  this assay are  summarized in Table 10.

-------
                                  33
                   TABLE 10.   ADENYLATE ENERGY CHARGE
     Criteria
      Critique/Comments
Test Organisms
Advantages
Limitations




Response to Chemicals

Assay Time*, hours

Special Equipment

Cost

References
Escherichia coli  is the major test
  organism.
Euglena or the human cell  line HeLa
  may also be used.

This is a rapid indication of metabolic
  state.
Test organism^,  coli is commercially
  available and relatively inexpensive.
This assay is applicable to a wide
  range of organisms and environmental
  and chemical conditions.
The assay can be converted to microbially
  immobilized macronutrients in the
  microbial energy charge assay.

Three parameters, AMP, ADP, and ATP,
  must be measured.
The test requires a skilled technician.
Analysis must be promptly performed.

Unknown

8, 62, 23, 9

Spectrophotometer

$920

Atkinson and Walton, 1967
Atkinson, 1969
Ching and Ching, 1972
Bostick and Ausmus, 1978
*See time and cost explanation, pp. 9-11 in text.

-------
                                        34

                           GROWTH AND CELL DIVISION
 Cloning  1929 Mouse Cells

          The L929 cloning  assay  is  an in vitro bioassay to examine the cyto-
 toxic  effect of a variety of toxicants.  The toxicants may include particulate
 or  soluble  (aqueous or limited organic) toxicants.
           The L929 cell  line  is  carried in Eagle's  Minimal  Essential  Medium
 containing  10 percent  fetal  calf  serum,  10,000 units of penicillin per 100 ml
 medium,  10,000  yg of  streptomycin  per 100  ml  medium,  and 10,000  ug  of  my-
 costatin per 500 ml  medium.   Cells  are cultured  in  75 cm2  tissue  culture
 flasks.   When  cells  are 75 to 90  percent confluent, 0.25 percent  trypsin is
 used to  remove  cells  from the flask.  A  1:10  dilution  of cells is made u'sing
 complete media, and cells are  seeded into new flasks.   Cells  should  be split
 every  3  to 4 days.
          A flask of L929 cells is trypsinized,  and  the  cells  are counted  and
 diluted  to  1  x  103   cells/ml,  8  x  102 cells/ml,  6  x 102  cells/ml,   4  x
 102 cells/ml, and 2  x 102  cells/ml.   The dilutions  of the cells  are  plated
 onto to  60-mm dish containing 4 ml  of complete  medium.   Twenty  plates  are
 needed at each cell concentration for  one complete test.  The  cells  are  per-
 mitted to attach  to  the tissue culture  dishes for 24 hours.   The plates  are
 then treated with various concentrations  of  the test chemical.   Five  concen-
 trations  of test chemical should be assayed in each cell dilution.  Therefore,
 six sets  of five plates  should be made:   one for each of  the  five concentra-
 tions  of the  test  chemical  plus one  set  to  be used  as  an untreated  control.
 The cells are exposed  to the test  chemical for 24 hours.   Following the treat-
 ment period, the cells are washed twice with  phosphate-buffered saline and  fed
 normal  growth medium.   Microscopic  examination  of the  plates  should  discern
 discrete colonies in  approximately 10 to 12 days.  At this time the plates  are
washed with  phosphate-buffered saline, fixed  with  methanol,  and  stained by
Giemsa.   The colonies  on the plates are  counted,  and a  plating efficiency is
determined.   The plating efficiency  is calculated as the  number  of surviving
cells expressed  as  a  percentage of the cells  planted:
                       £ of colonies per plate
                       	 X 100
                       # of cells seeded

-------
                                     35

An  evaluation  of the  cytotoxic  effect of the  test chemical  may  be made  by
comparing the  plating efficiency  of the  test  plates  with that  of control
plates.
         Details are summarized in Table 11.

Protozoan Clonal Viability

         This assay is based on the  observation that when cells  are  subjected
to  toxicants or stresses,  only a fraction of the  population survives and re-
produces.   Heaf and  Lee (1971) first  developed  this method  to measure  the
viability of Tetrahymena  after exposure to low temperatures.  This  viability
assay  is currently  being  adapted for  toxicity testing  (Persoone  and  Dive,
1978).
         In the assay J.  pyriformis is grown  axenically in the  dark.   The cul-
tures  are then  diluted to  about  5  cells/ml.   One  ml of the dilution  is  placed
in  each  well  (cup) of a 100-hole, plastic,  hemagglutination  tray.   Also,  a
toxicant  is  added  in  increasing  concentrations  to  the  wells  containing
Tetrahymena.  After 6  days  at  28 C, cells surviving certain toxicant  concen-
trations will  proliferate,  while those affected by other toxicant  concentra-
tions  will not  divide.  The number of wells containing growing  populations, as
well  as  the number of organisms  in  each  well,  can be counted with  the naked
eye and  recorded.  A schematic of the clonal  viability test method is shown in
Figure 1.  The  details on this assay are summarized in Table 12.

Human  KB Cell Growth Rate

         Nephelometric measurements, such as changes in the optical  density or
macromolecular  complement of cell cultures, provide a basis for monitoring the
growth of cell  populations.  In this assay, the inhibition  (or possible stimu-
lation)  of  mammalian  cell  growth is determined by measuring colorimetrically
the total  protein  present in  dividing  cells  both  before  and after incubation
with  a test chemical  (Oyama and Eagle,  1956).  Even though any of several cell
lines  could  be  employed, the  rapidly growing human tumor line KB or the mouse
tumor  lines P388 or L1210 are  excellent candidates for this assay.

-------
                                  36
                  TABLE 11.  CLONING L929 MOUSE CELLS
     Criteria
      Critique/Comments
Test Organisms

Advantages



Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment

Cost*

References
L929 mouse cell line.

The test organism is simple to culture.
Several concentrations of potential
  toxicants may be assayed simultaneously.

This assay must be performed by skilled
  technicians.
Specialized equipment is needed.
A very long time is required to obtain
  results of this assay.

Aromatic hydrocarbons (benzene, toluene-
  MEC is 5 to 50 ppm)
Detergents (sodium dodecyl sulfate-MEC
  is .005% w/v)
Inorganic ions-heavy metals (cobalt,
  nickel-MEC is 0.11 to 1
244, 326, 15, 9

Mammalian cell culture facilities

$750

Duke et al , 1977
Richardson, et al , 1977
*See time and cost explanation, pp. 9-11 in text.

-------
                         37
^
r0|
r^ ^
o o
/T-- O,
1
•»•
GOG
GCG
ceo
+
^* -
COO
OGG
IGSQ

1 TOXICANT
1 1

1 	
1
I
, 	 1 	
LlNCL'3ATiCN


I
^^>r
GOG
COG
'-^ T\ /T\
[ Vj Op
1
1
1
|
kC
1
1
Figure 1.  Schematic Representation of Viability Test
           Adapted to Toxicity Testing.    From Persoone
           and Dive (1978).

-------
                                  38
                 TABLE 12.  PROTOZOAN CLONAL VIABILITY
     Criteria
      Critique/Comments
Test Organism

Advantages
Limitations


Response to Chemicals

Assay Time*, hours

Special Equipment

Cost*

References
Tetrahymena pyriformis

Rapidly dividing cultures of test
  organisms are easily grown.
Many replicates and chemical concentrations
  can be done simultaneously.
The assay is not disrupted by particulate
  matter or color of the potential
  toxicant.
The TLso can ^e easily determined.
The assay can be performed by unskilled
technicians.

A long time is required to obtain
  the results of this assay.

Gases (ethylene oxide)

148, 210, 14, 9

None

$660

West et al, 1962
Heaf and Lee, 1971
Gardinono et al, 1973
Mouton and Hendrickx, 1974
*See time and cost explanation, pp.  9-11 in text.

-------
                                     39
           The test is conducted as  follows:   KB cells, seeded at 1020 -  g/ml
protein (2 to 3  x 10^ cells/ml), and the  appropriate  concentrations of  test
chemical are  mixed and  incubated  for 72  hours  at 37  C.   After  incubation,
total protein is determined in the test and untreated control cultures as  de-
scribed by Lowry  et  al  (1951).   For  significance,  untreated  control  cultures
must go through  at  least six cell  divisions.   The  number  of cultures in  the
control group varies  according  to  the formula 2Vn~T where  n is the  test  cul-
tures or number  of chemicals being tested.  A  positive  control, cells treated
with 6-mercaptopurine, exhibits  an  ED 50  between  .05 and 0.5 pg/ml.
          Criteria for cytotoxicity of test chemicals would be any  inhibition
of  growth  caused by the test chemical.   The  influence of a toxicant on  cell
growth  rate could  be  possibly extrapolated to the  development and  prolifera-
tion of tissues  and organs  (e.g., KB cell growth  rate  to  nasopharynx  lining
proliferation).
         Details of this assay are summarized  in  Table  13.

Human Embryonic Lung Fibroblast  (HI-38)  Cytotoxicity

           This  assay is used to measure  growth-inhibition  effects  of various
toxicants  on mammalian cells.
            Human embryonic  lung fribroblasts  (WI-38)  are  cultured  in  75-cm2
Falcon  flasks with Eagle's Minimum  Essential  Medium plus  mycostatin  (10,000
units/500   ml  medium), penicillin  (10,000  units/500 ml  medium),  streptomycin
(10,000 ug/100 ml medium), and heat-inactivated fetal calf serum (10 percent).
Cells  are  incubated  in  10 percent carbon  dioxide-humidified  atmosphere  at 37
C.  Only cells between the 15 and 35  subculture should  be used.
         After the cells reach about  90 percent confluence, one flask of cells
is used for conducting this assay.   There are  eighteen  60-mm plates per assay.
After  assembling  medium, cells, and  plates,  4 ml  of medium  is  pipetted  into
each plate.   The stock  cells in a 75-cm2  Falcon flask  are  then  trypsinized.
After  cell  counts and dilutions  are made, a  2  x  10^  cells/ml  suspension is
seeded  into each 60-mm plate.
          After cells have grown to 100 percent confluence (4 to 5 days), test
toxicant is added.  Cells  and test chemicals  are then  incubated for 20 hours.

-------
                                  40
                 TABLE 13.  HUMAN (KB) CELL GROWTH RATE
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment


Cost*

References
Human KB eel Is

The test organism is easy to culture.
Many potential toxicants at several
  concentrations may be tested
  simultaneously.
Inhibition of cell growth is usually an
  accepted standard of toxicity.
National Cancer Institute routinely
  uses this assay for cytotoxicity
  screening.

Specialized equipment is needed.
A skilled technician is required to
  perform this assay.

Inorganic ions-heavy metals (cadmium,
  nickel-MEC is 0.1 to 10 ug/ml)
Nucleotide analogues (deoxy-adenosine
  S'-triphosphate-MEC is > 5 x lO'5 M)
Aromatic hydrocarbons (toluene, benzene-MEC
  is 1 to 5 ppm)
Detergents (sodium dodecyl sulfate, Triton
  X-100-MEC is .001 to .005%)
Carcinogenic nitrosamines (dimethyl-
  nitrosamine-MEC is 5 to 20 ug/ml)

75, 125, 12, 8

Mammalian cell culture facilities,
  spectrophotometer

$620

Oyama and Eagle, 1956
*See time and cost explanation, pp.  9-11 in text.

-------
                                     41

Following incubation, the three  plates  of cells per test chemical  concentra-
tion (five different concentrations) are  washed in phosphate-buffered  saline
twice and then trypsinized.  The cells  are  collected by  centrifugation  at  500
g for 5 minutes.  The supernatant  is poured  off,  and 1  ml  of medium is  added
to the centrifuge tube.   The cells  are  suspended and counted  with  a  hemocytom-
eter.  The average number of  cells  recovered from each test chemical concen-
tration and  from control  plates is  determined.   Cell  counts from  the  plates
are  averaged  for all  the concentrations  of  the test  chemicals  and the con-
trols.  The average counts from the test chemical  plates  are  then  expressed as
a function of the number  of cells  obtained  from the control  plates.  A cyto-
toxicity curve for the test chemical is  constructed.  The curve is  an expres-
sion of the cellular survival  as a  function  of concentration  of  the  toxicant.
           Effects of toxic chemicals on  fibroblasts could be extrapolated to
effects on human connective or pulmonary tissue.
         Details on this assay are  summarized in Table  14.

Mitogen Stimulation of Lymphocytes

         Blastogenic transformation of  lymphocytes is  considered to  be  a mani-
festation of  lymphocytes  in cellular immunity.   Measurement of the effect of
test chemicals  on this  mitogen-induced blast transformation is  a measurement
of the effects on immune function.   Thymus,  spleen, or  lymph-note cell  suspen-
sions are cultured in the presence of mitogens such as  Concanavalin  A (Con  A),
phytohemagglutinin-P (PHA), and Pokewood  mitogen  (PWM).  Certain  cells  within
these populations respond to the presence of mitogens  by undergoing  blastogen-
esis.   The  response is quantitated  by monitoring  ^H-thymidine  incorporation
in mitogen stimulated and nonstimulated cultures.
          Varying concentrations of the test  substance are added  to microlym-
phocyte  cultures in Falcon microtest  II multi-well plates.   Each  well  is a
microculture  of  5  x  10^  lymphocytes  growing  in the  presence   or  absence
(control) of  a  mitogen  (PHA,  50 yg/ml  final;  Con A,  100 pg/ml  final).  Each
dosage  of  the test chemical  is  tested  in  quadruplicate with  the  lymphocyte
cultures.   Incubation  is pulsed  with  1  yCi  of 3H-thymidine.   Twenty-four
hours after pulsing, the cultures are harvested on glass-fiber filters using a

-------
                                  42
               TABLE 14.  HUMAN EMBRYONIC LUNG FIBROBLAST
                          (WI-38) CYTOTOXICITY
     Criteria
      Critique/Comments
Test Organisms


Advantages
Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment



Cost*

References
Human embryonic lung fibroblasts
  (WI-38)

An automatic cell  counter can be used
  to simplify this assay.
Many replicates and chemical concentrations
  can be tested simultaneously.
The assay result's  are easily obtained
  by direct counting.

A skilled technician with experience in
  microscopy is required.
Some specialized equipment is needed.
The possibility of human mistakes due
  to fatigure and boredom exists
  because of the tedious nature of
  the data collection.

Inorganic ions-heavy metals (nickel,
  cadmium-MEC is 0.1 to 1 yg/ml)
Gases (carbon monoxide)
Aromatic hydrocarbons (benzene, toluene,
  ethyl  benzene-MEC is 0.5 to 50 yM)

27, 176, 14, 9

Mammalian cell culture facilities,
  binocular microscope (optional),
  hemocytometer

$730

Baiile and Hardegree, 1970
*See time and cost explanation, pp. 9-11 in text.

-------
                                     43

multisample  harvesting  unit.   ^-thyroidine  incorporation  is  determined by
counting the filters, using liquid scintillation  spectrophotometry.
         To analyze the data, one must  (1)  compute  mean  radioactive  counts  per
minute (cpm) and standard error of mean for all control  values,  i.e., PHA,  Con
A, and medium;  (2) compute mean cpm  and  standard error  of mean  for  each quad-
ruplicate cell control,  i.e., cells and medium;  (3)  compute mean cpm and stan-
dard error of mean for each  quadruplicate  PHA- and  Con  A-stimulated cultures;
(4) for  stimulation  index, divide each  of the  quadruplicate  cpm  values  for
PHA-stimulated  cells  by  the mean  cpm  value  of the same cells  nonstimulated,
and average the four indices determined in this manner  for a mean stimulation
index  (repeat  for Con A and  PHA);  and (5)  compare  index  of  test-substance
treated and untreated cultures.
          Impairment of lymphocyte function by toxic chemicals  may foreshadows
the impairment of antibody formation and immune response in mammals.
         Details of this  assay are summarized in  Table 15.

Chick Embryo Development

          The assay is an attempt to predict toxicologic or teratologic (tera-
togenic) effects on higher vertebrates based  on  responses of chick  embryos to
potentially harmful  compounds.   Fertilized white leghorn eggs  are  candled to
locate the  air  cell.   A hole  drilled  through the  shell over the air  cell  is
the site  of  aseptic  injection of 0.1  ml of  a test chemical  into the  yolk of
the developing  embryo.  The  hole  is  covered  with tape and the  eggs are  incu-
bated  at 38  C  and  periodically  candled.    Dead  embryos are  pathologically
examined  and  surviving  chicks are  examined  over   a  2 to 6-week  period  for
weight change,  gross  abnormalities,  and  mortality.   At  least  20 eggs  are used
for each  chemical concentration tested to  add statistical significance to the
results.  Eggs hatch after 21 days so the entire procedure may be performed in
approximately 1 month.
         Details are summarized in Table 16.

-------
                                   44
             TABLE 15.  MITOGEN STIMULATION OF LYMPHOCYTES
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals




Assay Time*, hours

Special Equipment



Cost*

References
Mouse lymphocytes

The effect of a potential toxicant is
  defined for a developmental parameter
  as well as a growth parameter.
It is possible to determine a
  developmental change before a loss
  in viability or growth potential of
  test eel Is.

Some variation of responsivenss of
  lymphocyte preparations may interfere
  with this assay.
Great expense is incurred maintaining
  a mouse colony as a source of
  lymphocytes.
Specialized equipment is needed.
The assay must be performed by highly
  skilled technicians.

Fungal toxins (aflatoxins-MEC is
  5 to 20 ug/ml)
Inorganic ions-heavy metals (nickel,
  cadmium-MEC is 0.1 to 1 ug/ml)

76, 76,  11, 8

Scintillation counter, spectrophotometer,
  animal  rearing facilities, mammalian
  cell culture facilities.

$820

Save! et al, 1970
*See time and cost explanation, pp. 9-11 in text.

-------
                                  45
                  TABLE 16.   CHICK EMBRYO DEVELOPMENT
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
White Leghorn chick embryos

Large numbers involved make the results
  of this assay statistically meaningful.
Responses of test organism correlate well
  with other animal responses to
  traditionally toxic chemicals (lead
  acetate, mercury II chloride).
Since eggs are incubated under controlled
  conditions, maternal influence is not a
  variable, as it is in placental  animals.
The rapidly dividing cells may reduce the
  time necessary to elicit a response
  to possible toxicants.
This assay can be performed by unskilled
  technicians.

There is a lack of standardized methods
  in this assay.
An extremely long time is required to
  obtain the results of this assay.
Since responses are dependent on critical
  periods of development, responses may
  vary with each test chemical.
One species of test organism selected,
  White Leghorn, may be unrealistically
  sensitive or insensitive to some
  chemicals.
Response depends on several different
  variables: specific gravity,  solubility,
  pH, ionic concentration, and  coagulating
  effect.
Negative results may not be significant.
The lack of a placental barrier gives a
  questionable correlation between
  responses of chick embryos and responses
  exhibited by mammals.
Specialized equipment is needed.

-------
                                   46
                         TABLE 16.   (Continued)
     Criteria
      Critique/Comments
Response to Chemicals
Assay Time*, hours

Special Equipment


Cost*

References
Inorganic ions-heavy metals (lead,
  mercury, cobalt-LC/i is 0.1 mg)
Food additives (monosodium glutamate,
  sodium benzoate)
Nucleic acid analogues (5-fluorouraci1)
Antibiotics (tetracycline, methacycline,
  doxycycline)
Dithiocarbamates [bis(dimethyl
  thiocarbamoyl)-disulfide]
Organic solvents (carbon tetrachloride,
  n-butanol)
Hallucinogens [lysergic acid diethylamide,
  (LSD)]
Lathyrogenic agents (B-aminopropionitrile-
  LC62 is 0-63 mg)
Metabolic inhibitors (2,4-dinitrophenol)

720 (1 month), 720, 108, 11

Incubators, hatching facilities, rearing
  facilities, sterile injecting facilities.

$2510

Feldman et al, 1958
Mclaughlin et al, 1963
Gebhardt and Van Logten, 1968
Kury and Crosby, 1968
Hall, 1972
Pagnini et al, 1972
Flick et al, 1973
Messier, 1973
Palmer et al, 1973
Hulbert and Klawitter, 1974
Hall, 1976
Swartz, 1977
Zagris, 1977
Lee, 1978
Loomis, 1978
*See time and cost explanation, pp. 9-11 in text.

-------
                                       47

Trypan Blue Dye Exclusion by Human KB Cells

         The ability of cultured human cells to exclude the dye trypan blue is
a measure of a functioning cell membrane.
         Monolayer cultures of KB cells are incubated with a test chemical  for
24 hours.   Following the  incubation  period,  the cells  are removed  from  the
plates with a  rubber  policeman.   The  cell  suspension is placed in 15 ml  coni-
cal centrifuge tubes and centrifuged at 600 g  for 5  minutes.   The supernatant
is  discarded,  and  the  cells  are  resuspended  in 2  ml  of  phosphate buffered
saline.  An 0.66-ml aliquot of the cell suspension is mixed with  0.66 ml  of a
0.4 percent trypan  blue  solution.  A  cell  count and a viability determination
are  carried  out  for  each  concentration  level,  using   a  hemocytometer  or
cytograf.   Viable cells are those cells  that  do not take  up  the trypan  blue
dye.  Viability is calculated  by:

                   No.  of viable cells
                   	:	X 100 =  percent  viability
                     total  cell #
A Viability Index is also calculated as follows:

u- U-T-J.  T j      mean total  cell count of test                       . ,  .,.
Viability Index = mean tota1  Ce11 count of Contro1 X  mean  percent^viability

         Information from  this assay may  be extrapolated  to other cellular or
subcellular  membranes  because  other  cells   are  enclosed by   semi permeable
membranes which are structurally and functionally similar to the  lipid bilayer
surrounding KB cells.
         Details of this assay are summarized in Table 17.

CATALYSIS  (ENZYMATIC ACTIVITIES)

RNA Polymerase Activity

         RNA polymerase  is a multimeric enzyme that catalyzes the synthesis of
RNA  chains from  the  nucleoside  triphosphates  ATP,  CTP,  GTP,  and  UTP.   The
synthetic  reaction  has  an absolute requirement  for  a divalent  metal ion and

-------
                                  48
         TABLE 17.  TRYPAN BLUE DYE EXCLUSION BY HUMAN KB CELLS
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment


Cost*

References
Human KB cells

This assay can be partially automated
  by the use of a hemocytometer.
The test results are straightforward
  and easily obtainable.
A relatively short time is required
  to obtain the results of this assay.

Specialized equipment is needed.
A skilled technician with experience
  in microscopy is required.

Detergents (Triton X-100), sodium
  dodecyl sulfate-MEC is .001 to
  .005%)
Polycyclic aromatic hydrocarbons
  (naphthalene, anthracene-MEC is
  0.5 to 75 uM)
Inorganic ions-heavy metals (cadmium,
  lead-MEC is 0.1 to 1 ug/ml)

30, 77, 11, 8

Binocular microscope, mammalian cell
  culture facilities, hemocytometer

$600

Corning and Firth, 1969
*See time and cost explanation, pp.  9-11 in text.

-------
                                     49
normally requires DNA as  a  template.   RNA polymerase recognizes and binds  to
certain  base  sequences  in  DNA,  initiates RNA  synthesis,  elongates  the RNA
chain,  and  finally  terminates  RNA  synthesis  with  a release  of  a  new RNA
molecule.
          The standard wheat germ RNA polymerase II assay mixture,  in a  final
volume of 0.25 ml, contains  2.5 umol  of Tris-HCl  (pH  7.9); 0.25 umol of manga-
nese chloride; 12.5  ymol  of ammonium sulfate;  100 nmol  each of GTP, CTP, and
ATP; 1  yCi  of  (5-3H)UTP  diluted  to  a specific  radioactivity  of  1  uCi/0.1
nmol;  50  ug  of  heat-denatured  calf thymus  DNA;  and 125 ug of bovine  serum
albumin.
          The assays mixture is  'incubated for 15 minutes at  25 C,  and the RNA
is  precipitated  by  adding 2 ml  of 5  percent  (w/v)   ice-cold trichloroacetic
acid containing 25 mM sodium pyrophosphate.  After 5  minutes at 0  C, the pre-
cipitates are collected on  Whatman GF/C filters  and  are washed under suction
with five 4-ml rinses of ice-cold 2 percent trichloroacetic  acid  containing  10
mM  sodium  pyrophosphate  followed by 2  ml  of 95 percent  ethanol.   After the
filters  are  dried under  a  heat  lamp,  they  are  assayed for  radioactivity  by
liquid scintillation counting.
         By changing only the template and the  radioactive nucleotide, one  can
assay for several other polymerase activities involved in  gene replication  and
expression.   These  enzymatic  activities  include DNA  polymerase,  poly(A)-
polymerase,  and  polynucleotide   phosphorylase.   In  all   of these  polymerase
assays, test  chemicals  can  be  added to the  reaction  mixture prior to the  ad-
dition of the enzyme.
            By  effecting  RNA polymerase  activity, a  toxic   chemical would  be
modifying the mechanism  by  which  all  new cellular  proteins and  enzymes  are
produced.  Since RNA polymerase  is  present  in all  living  organisms,  results
could be extrapolated to all life forms.
         Details of this assay  are summarized in Table 18.

Adenyl Cyclase Activity

           Adenyl  cyclase  is a  hormonally  activated surface  membrane  enzyme
which  catalyzes  the  conversion   of  adenosine  triphosphate  (ATP) to  cyclic

-------
                                   50
                   TABLE 18.  RNA POLYMERASE ACTIVITY
     Criteria
      Critique/Comments
 Test Organisms
Advantages
Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment


Cost*

Reference
Either RNA polymerase purified from wheat
  germ or Escherichia coli may be used.

RNA polymerase is present in every living
  organism.
All assay components as well as E. coli
  and wheat germ enzymes are commercially
  available and are relatively inexpensive.
Hundreds of assays can be completed daily. .
Many replicates and chemical concentrations
  can be done simultaneously.
Noting the effects of chemicals on RNA
  polymerase will contribute to pinpointing
  molecular mechanisms of chemical action.
A very short time is required to obtain the
  results of this assay.

Colored chemicals and precipitates inter-
  fere with this assay.
A high degree of technical skill and
  training is necessary to assay for RNA
  polymerase.
Specialized equipment is needed.

Metal carcinogens (cobalt-Iso is 0.5
  mM, lead)
Antibiotics (actinomycin D, proflavine,
  mithramycin, rifamycin)
Carcinogenic nitrosamines (dimethyl-
  nitrosamine, azobenzene derivatives)
Polyanions (heparin, polyethylenesulfonate)
Metal mutagens (lithium-Igg is 0.2 M)
Fungal toxins (alpha-amanitin, aflatoxin)
Nucleotide analogues (2'-0-methyl-adenosine
  S'-triphosphate)

1.5, 5, 5, 8

Millipore filtration manifold, liquid
  scintillation counter

$530

Polya, 1973
Jendrisak and Burgess, 1975
Hoffman and Niyogi, 1977
Glazer, 1978
*See time and cost explanation, pp. 9-11 in text.

-------
                                     51

adenosine monophosphate (cAMP).  The latter (cAMP) is an important  regulatory
molecule in both prokaryotic and eukaryotic  cells.
           WI-38 human diploid cells are  seeded  at  2 x 106 cells/60-mm dish.
Various doses of the test chemical are  added  at  the time of culture  seeding.
Cultures are  incubated for  24 hours.   Treated  and control   cells are  then
processed to  determine  adenyl  cyclase activity.   After trypsinization,  cell
pellets are obtained by centrifugation and washed three times  in  a  10 mM  Tris
buffer (pH 7.4)  containing 0.1  mM dithiothreitol  at 0 to 4 C.  After the final
wash, buffer  is  added  followed by ice-cold magnesium chloride and  sucrose  to
final concentrations of 3  mM and 250  mM, respectively.   Better  than  99 percent
breakage of WI-38  cells  is  observed.  Broken cells  are subsequently  centri-
fuged at 2000 g  for 15 minutes, and the pellet is suspended  in  buffer  contain-
ing 250 mM sucrose, 3 mM  magnesium chloride,  0.1  mM  dithiothreitol, and 10  mM
Tris buffer (pH  7.4)'.
              The  broken  cell  pellet  is  used for the  adenyl  cyclase  assay.
Reaction mixtures contain 2 mM  ATP,  6.6  mM magnesium chloride, 1.0 mM  dithi-
othreitol, 40 mM Tris  buffer (pH 7.4),  and 0.05  M sucrose  in a  final volume  of
0.5 ml.  Reactions are initiated by adding 40 to 80  g of protein to  the  cell
preparation.   After incubation at 37  C  for 15  minutes,  the  reaction  is stopped
by adding trichloroacetic acid to a  final  concentration of 5  percent.  After
centrifugation,  the  supernatant is  treated  three times with  ethyl  ether  to
remove the trichloroacetic  acid.   The  solution  is  analyzed  for cAMP using a
radiotracer competitive protein  binding method  (commercially  available).   An
ATP regenerating system composed of 10  mM creatine phosphate and five  units  of
creatine phosphokinase/0.5  ml  of  incubation  mixture is  used  in all  experi-
ments.  Enzymatic activity is expressed as the amount of cAMP  produced.
         Despite the fact  that cAMP plays a key  role in controlling  biological
processes, the  correlation  between  a  chemical   effect  on  adenyl  cyclase and
cellular or tissue toxicity would require extensive research and development.
         Details of this assay are summarized in Table 19.

Lysosomal Enzyme Release

         The  destabilization of  internal  cellular membranes  produced  by toxic
chemicals can be assessed by measuring the release of certain enzymes  from the

-------
                                   52
                    TABLE  19.  ADENYL CYCLASE ACTIVITY
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals



Assay Time*, hours

Special Equipment


Cost*

References
WI-38 human diploid cells

The assay measures a specific enzymatic
  activity at a surface membrane. This
  enzyme plays a key regulatory role in
  cellular metabolism.
This assay assesses a specific physio-
  logical process as well as an
  organellar function.
A relatively short time is necessary to
  obtain the results of this assay.

Screening large numbers of chemicals
  is time consuming due to the
  requirement for processing cell membranes
  before the enzyme assay, followed by the
  cAMP assay.
Some specialized equipment, is needed.
This assay must be performed by highly
  skilled technicians.

Inorganic ions-heavy metals (lead,
  nickel-MEC is .05-10 ug/rnl)
Detergents (Triton X-100-MEC is .001-.05%)

29, 79, 14, 9

Mammalian cell culture facilities,
  liquid & scintillation counter

$880

Klein et al, 1978
*See time and cost explanation, pp. 9-11 in text.

-------
                                     53
lysosomes into  the cytoplasm.   In  this assay, the  release  of the  lysosomal
enzyme acid phosphatase is measured  histochemically.
            KB  cells,  seeded  at  10$  cells  per 60-mrn  dish,  are pipetted onto
coverslips and then various doses of a test chemical are administered.  After
treatment for 24 hours, coverslips are washed  in isotonic saline  and  then are
incubated for 15 minutes  in a medium  of  10  mM g-glycerophosphate  and 50 mM
acetate buffer  (pH 5.0) containing  4 mM lead nitrate and 50 mM sodium  chlor-
ide.    Following incubation, the coverslips are fixed for 10  seconds in one
percent acetic acid,  transferred to  hydrogen  sulfide-saturated  water  for
5 minutes,  washed  in  distilled water,  and mounted.   Staining  of acid phos-
phatase is  indicative of  damaged lysosomal membranes  because intact  lysosomal
membranes are impermeable  to the g-glycerophosphate  substrate.
         Other mammalian cell lines  (HeLa,  mouse L)  can  be used in this  assay.
         It should  be noted that this assay measures the effect of a  toxicant
on an  organellar membrane inside the cell.   This assay does not  measure cell
lysis.
           This  assay measures the perturbation of  an important cellular com-
ponent.  So, the enzymes,  released from lysosomes ruptured by  a toxicant, can
kill  cells and cause tissue necrosis.  This assay can be used as quick,  quali-
tative screen. Microspectrophotometric techniques  could be used to quantitate
this  assay.
         Details are summarized in Table 20.

Macromolecular Synthesis in KB Cells

           This  assay  is used to assess the  effects of test chemicals  on the
syntheses of macromolecules.  The rate  of  incorporation  of  radiolabelled  pre-
cursors into  an acid  precipitable  form (macromolecular  form) is  used as  a
measure of  the  synthetic  rate,  ^^-uridine  incorporation is  used to measure
RNA  synthesis,  ^H-thymidine incorporation  to  measure  DNA  synthesis,  and
3H-leucine  incorporation  to  measure protein  synthesis.    The protocols  for
measuring any of these three parameters are the same  since  the radiotracer  is
the only variable.

-------
                                  54
                  TABLE 20.  LYSOSOMAL ENZYME RELEASE
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals


Assay Time*, hours

Special Equipment


Cost*

References
Human KB cells

This assay measures a specific membrane
  alteration before a loss in viability
  occurs.
The test results are straightforward and
  easily obtainable.
A relatively short time is required to
  obtain the results of this assay.

This assay requires carefully controlled
  conditions of incubation to prevent
  nonspecific lysosomal damage or staining.
A skilled technician with experience in
  microscopy is required.
Specialized equipment is needed.

Abrasives (silica)
Detergents (Triton X-100-MEC is .05-1%)

29, 76, 9, 8

Microscope, mammalian cell culture
  facilities

$560

Grasso et al, 1973
*See time and cost explanation, pp. 9-11 in text.

-------
                                     55

             Approximately  2.0 x  10^  KB  cells  are seeded  into  60-mm petri
dishes.   Various dosages of the test  chemical  are  added at the time of  seeding
of the cultures.  Untreated controls are  included.  After 24 hours of  incuba-
tion, the  cultures  are pulsed with  1  uCi/ml  of  the  appropriate radiotracer
(^H-thymidine,   ^H-uridine,  or  3n_-|euc-jne).    After  a  2-hour  pulse,  the
monolayer  is rinsed  with cold physiological  saline, trypsinized,  and resus-
pended in  saline.  Aliquots of the suspensions are  taken for cell count.  The
remaining cells are  lysed  by  the addition of sodium deoxycholate  to a final
concentration of 0.5 percent.   An equal  volume of  cold 10 percent trichloro-
acetic acid  is added  to  the  suspension, and  the  resulting  precipitate  is
collected  on  glass-fiber  filters.    The filters  are then  dried,  and the
radioactivity is determined  by liquid scintillation  spectrophotometry.   The
results are calculated  as counts per minute of isotope  incorporated per cell.
         This assay could be combined and correlated with other  biochemical  or
enzymatic  assays.    For  example,  the  chemical   inhibition  of  cellular RNA
synthesis  could be correlated  with  the effect of that chemical  on RNA  poly-
merase activity.  Also,  this  assay protocol can  be expanded to monitor  other
cellular syntheses by  simply  utilizing other labelled  precursors  (e.g., -fy-
acetate for fatty acid  synthesis).
         Details of this assay are summarized  in Table  21.

OTHER CELLULAR  PROCESSES

Cyclosis

         Cyclosis or protoplasmic streaming is the regular,  cyclic  movement  of
particles  within a  cell.   Lucas  (1977)  has  devised an  assay to measure the
inhibition of cyclosis  caused by various  levels  of ammonium sulfate.   This as-
say could be adapted for toxicity testing.
         In this procedure, internodal  cells of the  al ga  Chara are  cut from an
algal mat  1  day prior  to the  experiment.   After cutting,  the cells  are soaked
in 1.0 mM sodium bicarbonate buffer  (pH 9.0) and  are subjected  to  a  regime  of
13 hours of  light and  then 11  hours  of dark.   All cells  are illuminated  under
fluorescent lights (10 W/sqm)  for  2  hours before  the start of  an  experiment.

-------
                                  56
            TABLE 21.  MACROMOLECULAR SYNTHESIS IN KB CELLS
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment


Cost*

References
KB Human cell cultures

This assay measures specific functional
  properties of cells and can be
  indicative of functional alteration
  or loss before general toxic effects
  (such as death) are observed.
A relatively short time is required to
  obtain the results of this assay.

This assay must be performed by skilled
  technicians.
Specialized equipment is needed.

Inorganic ions-heavy metals (nickel,
  lead-MEC is 0.1 to 10 yg/ml)
Polycyclic hydrocarbons (naphthalene-
  MEC is 1 to 50 uM)
Detergents (hexachlorophene-MEC is
  5 to 100 ug/ml)

34, 78, 11, 8

Liquid scintillation counter, mammalian
  cell culture facilities

$720

Carr and Ligaton, 1973
*See time and cost explanation, pp.  9-11 in text.

-------
                                     57

At the beginning of the test,  cells  are soaked for 1  hour  in  a  solution  of  the
chemical  to be  tested.   After exposure to the  chemical,  cells are examined,
and cyclosis is measured with a  binocular microscope having  an ocular microm-
eter.   The time required for a standard-size  cytoplasmic  particle to traverse
1000 urn  is  measured with a stopwatch.  Rates of cyclosis are measured in  10
cells  and are expressed as  the mean  _+ standard error.
            It  would be  difficult to correlate a specific chemical effect  on
algal   cyclosis  with a  chemical  effect  on  metabolic  processes  in mammalian
cells  and tissues.
         Details on this assay are summarized  in Table  22.

Hemolysis

            This bioassay is capable of identifying the  hemolytic effect  of
various potential  toxicants.   To measure this hemolytic  effect,  solutions  of
varying  concentrations   of  the  suspected toxicant,   and  a  buffered  saline
solution  containing 0.1 mM  ethylenediaminetetraacetate (EDTA),  are  prepared
and washed  rat erythrocytes  are added.   The  concentration  of  these  cells
should be  0.5   percent  (volumetrically).   The  solutions  are  incubated for 1
hour and then centrifuged for 10 minutes at  1000 g to remove intact red  cells.
The supernatant fraction is then spun for 15  minutes at 20,000 g to remove any
remaining particulate matter.  The  optical densities of the  final  supernatant
fractions are measured  at  542 nm to estimate hemoglobin.  Addition  of  a  like
amount (0.5 percent) of red blood cells to water  gives  the  value  for  100  per-
cent hemolysis.
         Information from this assay may be  extrapolated to other cellular and
subcellular membranes  because  other cells are  enclosed by  semipermeable  mem-
branes which are  structurally and  functionally  similar to  the  lipid  bilayer
surrounding erythrocytes.   Also, since erythrocytes contain hemoglobin which
transports oxygen  to tissues, any erythrocyte aberation would cause  detrimen-
tal effects elsewhere in the body.
         Details on this assay are summarized in Table 23.

-------
                                  58
                          TABLE 22.  CYCLOSIS
     Criteria
      Critique/Comments
Test Organisms



Advantages

Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment


Cost*

References
Chara coral!ina is the major organism.
Nitella translucens and Elodea may also
  be used.

None

Inhibition of cyclosis goes from 0 to
  100 percent with a small change in the
  concentration of certain interfering
  chemicals.
The test organism is very difficult to
  culture.
A skilled technician experienced in
  microscopy is necessary.
A relatively long time is required to
  obtain the results of this assay.
Some chemicals may cause increased,
  instead of decreased streaming.
Only one assay at one test chemical
  concentration can be performed in
  one hour.
There is a variable rate of streaming
  which is dependent on cell volume.
Specialized equipment is needed.

Metabolic inhibitors (2,4-dinitrophenol).
Chlorinated aliphatics (chloroform).
Inorganic salts (ammonium sulfate-
  125 is 0.5 mM).
Gases (oxygen)
Sugars (mannitol, sucrose)

30, 141, 58, 11

Binocular microscope with ocular
  micrometer

$1810

Pfeffer, 1938
Thaine, 1964
Geis and Morrison, 1971
Lucas, 1977
*See time and cost explanation, pp.  9-11 in text.

-------
                                  59
                          TABLE 23.   HEMOLYSIS
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment

Cost
Rat or human erythrocytes
              \
This assay can be performed by an
  unskilled technician.
A very short time is required to obtain
  the results of this assay.
The test results are straightforward
  and easily obtainable.
Erythrocytes from several sources are
  commercially available.
Many chemicals and varying chemical
  concentrations may be tested
  simultaneously.

Rat and human erythrocytes vary from
  batch to batch because of nutritional
  and genetic differences in donors.
With some chemicals it is difficult to
  establish a dose-response relationship.

Sulfhydryl inhibitors (p-chloromer-
  curibenzoic acid-EC4Q is 37.4 mg)
Inorganic ions-heavy metals (lead, mercury)
Hormones  (epinephrine, prostaglandin £2)
Peroxides (peroxidized microsomal lipids,
  hydrogen peroxide)
Abrasives (silica)
Arylhydrazines (phenyldrazine-ECyy is
  100% solution, m-toylhydrazine)
Detergents (Triton X-100)
Inorganic ions-halides (iodide)
Ionic surfactants (alkyltrimethylammonium
  halides)
Chlorinated antibacterials (hexachloro-
  phene)
Industrial particulates  (asbestos)
Buffers (Tris-HCl-ECioo  is 100% solution)

2, 4, 4, 8

Spectrophotometer or colorimeter

$440

-------
                                  60


                         TABLE 23.  (Continued)
     Criteria	Critique/Comments
References                   Sheets et al, 1956
                             Allen and Rasmussen, 1971
                             Lessler and Walter, 1973
                             Itano et al, 1974
                             Klebanoff and Clark, 1975
                             Luthra et al, 1975
                             Majer, 1975
                             Light and Wei, 1977
                             Summerton et al, 1977
                             Pesh-Iman et al, 1978
                             Zaslavsky et al, 1978
*See time and cost explanation, pp. 9-11 in text.

-------
                                     61

Protozoan Vacuole Contraction

           This  assay  is  based  on the observations that contractile  vacuoles
function  in  regulating osmotic pressure  (Rifkin,  1973) and  expelling  waste
substances from  the  cell.    Nilsson  (1974)  developed  an assay to measure  the
effect of a foreign  substance  on  vacuolar contraction in Tetrahymena.   Under
favorable conditions,  the  vacuole contracts  at  regular intervals.    However,
when the protozoan is stressed,  the timing of the intervals  may  be altered.
             In  the  assay, J_.  pyriformis is  grown  axenically in an  enriched
medium.   Aliquots of the cells  are then incubated at 28  C in the test  chemical
solution.  Observations are made using a light microscope, a Reichert  anoptral
optical  system or a similar viewing  system, during  the 1-hour period,  with
expulsion intervals  of  vacuoles from  several cells being recorded.   The time
required to reach  normal  size  and the  expulsion intervals  for  control  cells
are  also  recorded.   The  time intervals  for individual cells are  recorded
separately.
          It would be difficult to correlate results  from this assay with data
obtained from mammalian cells  and tissues.   However, if vacuolar  contraction
were developed as a toxicity assay,  those  results could complement  data ob-
tained  from  the   protozoan clonal  viability assay and  the  protozoan  motilty
assay.
           The use of protozoans  as test  organisms in toxicity  studies  would
appear to bridge  the gap between  undifferentiated  prokaryotic organisms, such
as bacteria, and the more complex  metazoa (Woodard, 1976).
         Details  on this assay  are summarized in  Table 24.

Protozoan Motility

         Bergquist and Bovee (1974) conceived an  original method for measuring
the motility of ciliates by microphotography.
          Tetrahymena  pyriformis  is centrifugally  pelleted  and separated from
axenic growth medium,  washed,  and again  pelleted  centrifugally.   Then  it is
introduced by pipette  into a holding  chamber.  For the assay, greater than 98
percent of the organisms should be motile.  The test chamber is covered at its

-------
                                  62
                TABLE 24.  PROTOZOAN VACUOLE CONTRACTION
     Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals

Assay Time*, hours

Special Equipment

Cost*

References
Tetrahymena pyriformis

The test organism is easy to obtain
  commercially and culture.
The effects of potential toxicants can
  be easily observed.
Vacuolar contraction can be standardized
  by controlling temperature, the age of
  cells, and the nutritional state of
  eel Is.

Response times may vary even in a single
  cell.
A long time is required to obtain the
  results of this assay.
The assay must be performed by skilled
  technicians with experience in
  microscopy.
Vacuolar contraction varies with vacuole
  size and a cell may contain more than
  one vacuole.
Numerous observations must be made.

Dipolar solvents (dimethyl sulfoxide)

17, 143, 30, 10

Light microscope, temperature control unit

$1130

Rifkin, 1973
Nilsson, 1974
Patterson and Sleigh, 1976
*See time and cost explanation,  pp.  9-11 in text.

-------
                                     63
bottom by #5  Whatman  filter paper and suspended  in  200  ml  of test  solution.
The pH is monitored and  readjusted to 7.0 as needed.  After  1  hour, samples
are pipetted onto clean slides  for microscopic examination.  Multiple-exposure
photographs   are  taken  stroboscopically  using   a  perforated aluminum  disc
attached to a  stirring  motor,  which  is equipped with a  variable-speed reduc-
tion gear,  permitting  optimal  image-spacing.  The  revolving  perforated disc  is
interposed  between a  Zeiss  RA  microscope  and the removable light,  permitting
full use of the  microscope's  optics  and  lighting.   Negative-image  films are
then projected onto a frosted  glass screen and  maximal-speed  paths  and linear
spacings are measured.  As an  end point, the  distances between the  ciliates  in
the multiexposed  photomicrographs are measured  very  easily by projection  of
the negatives onto a large screen.  This  method permits  large data  samples  to
be obtained quickly and easily.  The results  are then tested statistically for
comparative and descriptive purposes.   This  assay might be automated by em-
ploying a computer and a TV.
            A  chemical inhibition  of  protozoan  flagellar or  ciliary function
might be similar to effects on mammalian tracheal tissues.   The advantage  of
using protozoans in toxicity  studies  is  mentioned  in  the description of the
vacuole contraction assay.
         Details on the assay  are summarized  in  Table 25.

Phagocytosis by Alveolar Macrophages

           This  assay employs  a  primary  cell  line,  alveolar macrophages,  to
define the acute cellular toxicity of particulates and other chemicals.   Toxic
effects are assessed by measuring a macrophage function,  phagocytosis.
          Rabbit alveolar macrophages are harvested.   The cellular composition
should contain a minimum of 95 percent alveolar  macrophages.  The cell  suspen-
sion is then adjusted to a concentration of 1 x  105 cells/ml.
           One-mi  aliquots of  the  cell  suspension are placed in 60-mm  tissue
culture  plates and the  macrophages  allowed to adhere.   After  2  hours,  the
medium is decanted and 5 ml  of fresh medium is  added to each plate.
          The test chemical is diluted to the desired  concentration with cell
culture medium and  1-ml  aliquots are added  to  each  plate.    Initially,  three

-------
                                  64
                     TABLE 25.  PROTOZOAN MOTILITY
     Criteria
      Cri t i que/Comments
Test Organisms
Advantages
Limitations
Response to Chemicals



Assay Time*, hours

Special Equipment

Cost*

References
Tetrahymena pyriformis is the major
  test organism.
Paramecium caudatum may also be used.

The test organisms are easy to culture.
The decrease in motility is usually
  related to the concentration of the
  potential toxicant.
Large data samples may be easily obtained.

Precipitates or particulate matter may
  interfere with this assay.
Specialized equipment is needed.
There is a lengthy film development
  period in microphotography.
This assay requires a skilled technician
  with experience in microscopy.

Heavy metals (nickel, cadmium)
Ionic detergents (sodium dodecylsulfate,
  sodium stearate)

23, 136, 27, 9

Microphotography unit

$1000

Andrivon, 1968, 1972
Dryl and Bujwid-Cwik, 1972
Berquist and Bovee, 1973, 1974
Perkins and Cieresko, 1973
*See time and cost explanation,  pp.  9-11  in text.

-------
                                     65

concentrations of test chemical  are used with three replicates per dose.  The
plates  are incubated in a humidified 95 percent air, 5 percent carbon dioxide
atmosphere at 37 C for 20 hours.   The plates may be  rotated for the first hour
to ensure uniform exposure of  the  test  material.  At the end of the incubation
period, the medium is decanted and fresh medium added.
           Phagocytic activity is  measured by addition of  1.1  urn polystyrene
latex  particles  to  alveolar  macrophages cultured  in Lab-Tek  four-chamber
microslides  (approximately 25  particles/cell  in  1  ml  of  medium).   One hour
after  the  addition  of  latex  particles,  the  slides  are then  exposed  for  an
additional 5 to 6 minutes with 1:1 aqueous dilution of Wright's stain.  After
air drying,  the slides are placed  in  xylene  for  one  hour to dissolve  extra-
cellular  particles.    Following  an  additional  drying  step,  the  slides  are
mounted with permount.  Phagocytic  activity is determined under oil  immersion
by scoring  a minimum  of  200  cells.   Each cell   that  contains at  least  one
particle is  considered phagocytically active.   Typically, 80 to 90 percent  of
the cells in control cultures  ingest one or more particles.
         This assay is already in  limited  use  as a toxicity assay.
         Details on this assay are summarized  in Table  26.

Ami no Acid Transport

           A measurement of plasma  membrane function  is  active transport and
exchange  of  molecules  into and out of the cell.    This  assay tests  membrane
function by measuring the active  transport of  the  amino acid  histidine  into  KB
cells.
           For this assay, 10^ KB  cells in 3  ml  of suspension culture  medium
are exposed to  various doses of the test  chemical  for  24 hours.  At  the end  of
the exposure period, the cells are washed and then  suspended in  incubation
medium containing  131  mM sodium  chloride, 5.2  mM  potassium chloride,  1.3  mM
magnesium  sulfate,  and  1.0  mM calcium  chloride   in  10  mM  sodium  phosphate
buffer (pH  7.4).   One  uCi  of ^H-histidine is  added,  and the mixture  is  in-
cubated with agitation at 37 C.  Samples are  taken  every  minute for  5  minutes
for radioactivity  and  cell  number  determinations.   For measurements  of histi-
dine uptake,  the cells  in  each  sample are  washed in  cold  saline  to  remove

-------
                                   66
            TABLE 26.  PHAGOCYTOSIS BY ALVEOLAR MACROPHAGES
     Criteria
      Crit1que/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals




Assay Time*, hours

Special Equipment


Cost*

References
Rabbit alveolar macrophages

The assay measures a functional process
  of macrophages, phagocytosis, and
  indicates specific functional alterations
  produced by test substances.
A relatively short time is required to
  obtain the results of this assay.
Alterations in phagocytosis occur before
  any general loss in cellular viability.

A great expense is incurred maintaining a
  rabbit colony as a source of macrophages.
The assay can be performed by skilled
  technicians.
Other specialized equipment is needed.
The assay is labor intensive in the
  preparation of macrophages and in
  monitoring results.
Macrophage preparations may vary in
  responsiveness from day to day.

Gases (cigarette smoke, fly ash-MEC is
  10 to 100 ug/ml)
Inorganic ions-heavy metals (cadmium,
  zinc-MEC is 25 to 100 mM)

27, 27, 17, 9

Microscope, animal rearing facilities,
  mammalian cell culture facilities
$890

Green and Carol in,
Duke et al, 1977
1967
*See time and cost explanation, pp. 9-11 in text.

-------
                                     67

extracellular histidine.  The  total  radioactivity  in the cells is determined
by  liquid  scintillation  counting.    Rates  of  histidine transport  are then
determined   and   compared  by   plotting  the  concentration  of  intracellular,
labelled histidine  against  the  extracellular  concentration  by  the classic
method of  Lineweaver  and Burke.   Toxicity is  indicated  by decreases  in the
rate of histidine transport  as  compared to  untreated  controls.
          Information  from this assay may be extrapolated to other cellular  or
subcellular membranes because  other  cells  are  enclosed by  semi permeable mem-
branes which  are structurally  and functionally  similar  to  the lipid bilayer
surrounding KB cells.
         Details on this assay  are summarized  in Table  27.

OTHER POTENTIAL PHYSIOLOGICAL TOXICITY ASSAYS

           Several  other assays show promise as toxicity  screens  and  are cri-
tiqued below.   In each case,  few data on  the  assay or  on effects  of known
toxicants  exist.   For  the   chlorophyll   fluorescence  assay,  much of  the
information is  in  press  and will  appear in the  near future.   However,  it  is
impossible  for  us to develop  a  complete protocol  for these  assays  with the
information presently  available.
              The Microtox bacterial  luminescence  assay  designed by Beckman
Instruments,   Carlsbad,  California,  shows   promise   as  a  potential   toxicity
screen.
         All   living organisms  have certain  structural  and metabolic  similari-
ties.   It  is  often possible to extrapolate studies  performed  on  one organism
to other living  systems because of  these similarities.   Cells  of luminescent
bacteria are structurally and  functionally  similar  to other  living cells.  The
semipermeable membranes surrounding  all cells  are quite similar.  In  addition,
certain metabolic processes  (e.g., respiration)  are common to  all  cells.
         According to Beckrnan, the Microtox system is  simple,  rapid, inexpen-
sive,  and  accurate.    From  the  data  available,  this  appears  to  be  true.
Preliminary test  results  also  seem  to correlate with  results  of  the 96-hour
fish  acute toxicity test.   Although  this  assay appears to  be  an  effective
toxicity screen, the  methods   and   results  still   need  to be  validated  by

-------
                                  68
                    TABLE 27.  AMI NO ACID TRANSPORT
      Criteria
      Critique/Comments
Test Organisms

Advantages
Limitations
Response to Chemicals
Assay Time*, hours

Special Equipment


Cost*

References
Human KB cells

Simple kinetics  (one or tv/o points)
  could allow time for several chemical
  concentrations to be tested
  simultaneously.
The test organism is easy to culture.
The assay can detect alternations in a
  specific membrane process before
  generalized toxicity.
A relatively short time is required to
  obtain the results of an assay.

If detailed kinetic measurements are made,
  only one concentration of one specific
  chemical can be tested at a time.
A highly skilled technician is required
  to perform this assay.
Many measurements are required to obtain
  the results of this assay.
Some specialized equipment is required.

Detergents (Triton X-100, sodium
  deoxychloate-MEC is .001 to .05%)
Inorganic ions-heavy metals (nickel,
  cadnrium-MEC is 10 to 50 mM)
Inorganic salts  (magnesium chloride,
  calcium carbonate)

29, 53, 11, 8

Liquid scintillation counter, mammalian
  cell culture facilities

$810

Matthews et al, 1970
*See time and cost explanation, pp. 9-11 in text.

-------
                                     69

independent researchers.   After  significant  testing with known toxicants, an
objective decision can be made about  the  utility  of  the Microtox system.
           Another  promising  assay  is  the chlorophyll fluorescence assay de-
veloped  by  Arntzen,  Steinback,  and others  at  the  USDA  laboratory  at the
University of Illinois, Urbana.
           Fluorescence of living  leaves  has been  known  for  over 100 years,
having been  recognized by Muller in 1874  as a pathway of energy  dissipation
which competes with energy utilization  in  photosynthesis and  with heating of
the leaf.  Since Muller's time, studies  of  in vivo chlorophyll  fluorescence in
algae, in leaves, and  in chloroplasts of  higher plants have improved our  pres-
ent understanding of the light reactions  of photosynthesis.
         Quite recently, in vivo  chlorophyll  fluorescence measurement  has also
begun to  be  recognized as a  means  of detecting damage in intact  plants sub-
jected to environmental stresses  and deleterious agents.   The technique  is an
attractive one because  data collection is  easy,  fast,  and nondestructive, and
can be done in the field.  The potential  applications  of  fluorescence  measure-
ment  at  the  whole  plant  level  probably  will  not be  limited  to  detection of
stress-induced damage  but  may be extended  to use  as a  versatile  diagnostic
tool  in  plant pathology  and  as  a  screening  tool  in plant  genetics.   This
fluorescence  assay could be used to  complement results from the Hill  reaction
and/or greening assays and to provide a  broad data base about  toxic effects on
plants.
          McFarlane, Rogers,  and  Bradley at U.S.  EPA,  Environmental Monitoring
and  Support  Laboratory,  Las   Vegas, are  developing  a  rapid  toxicity  assay
involving tritium oxidation  by soil  microorganisms.  In this  assay,  v/ater  is
added to  air-dried  soil  in  a reaction  vessel,  and  the  slurry   is  incubated
overnight.   Tritium is injected into the  reaction  vessel and, after a  fixed
time, the  amount  of tritium  oxidized to water  is  determined  using  a  liquid
scintillation  spectrophotometer.   Toxicity  is  determined by  adding  a  fixed
amount of potential toxicant  to the  reaction vessel  prior to the addition  of
the tritium.    The oxidation  rate of  this  test sample is  compared  with that  of
the standard (untreated) sample.  Even though  several chemicals  (e.g., silver
nitrate,  monuron,  cadmium chloride) have  been  tested  using  this  assay,  the
test  organisms  are  not standardized, and  different soil samples  may contain

-------
                                      70

different populations of microbes.  This toxicity assay could probably be used
only as a pretest to indicate the need for further testing.
           From  the  limited  available information, these  assays  appear  to  be
excellent candidates for use as toxicity assays.   Since  we do  not have suffi-
cient information to evaluate them by the same criteria used to evaluate other
assays in this  report,  any decision  about  their utility  as toxicity screens
would be premature.  However, it appears that little laboratory development  of
these assays would be necessary.  As  more  information  on these assays becomes
available, objective ratings will be possible.

-------
                                     71

                        TABULAR COMPARISON OF CRITERIA
          On the following pages are five tables  (Tables 28 through  32)  which
show the relative  strengths  and weaknesses  of these 24  physiological  assays.
These tables provide,  at  a glance, comparative data on  which  specific recom-
mendations are based (see Discussion and Recommendations).   With  the  exception
of the "data base" category (Table 32),  the  criteria used in these five tables
are defined and  discussed  in the introduction.   The  "data base" category  in
Table  32  refers  to  the  relative  amount  of  data  available  about  chemical
effects on a physiological  process.  The data base for  each assay was rated as
good (+++),  fair (++), or  poor  (+).  This is merely a  subjective rating based
upon sources revealed during our literature  search (see Appendix).

-------
                                   72


                   TABLE 28.  SOURCE OF TEST ORGANISM
                                      Culture   Animal   Commercially
	Assay	or grow  facility    prepared

Acetylene Reduction                      X
Hill Reaction                            X
Greening                                 X
RuDP Carboxylase Activity                X
Photosynthetic Oxygen                    X
  Evolution
Respiration in HeLa Cells                X
Adenylate Energy Charge                  XX           X
Cloning L929 Mouse Cells                 X
Protozoan Clonal Viability               X
Human (KB) Cell Growth Rate              X
Human Embryonic Lung Fibroblast          X
  (WI-38) Cytotoxicity
Mitogen Stimulation of                             X
  Lymphocytes
Chick Embryo Development                           X
Trypan Blue Dye Exclusion by             X
  Human KB Cells
RNA Polymerase Activity                  X                     X
Adenyl Cyclase Activity                  X
Lysosomal Enzyme Release                 X
Macromolecular Synthesis in              X
  KB Cells
Cyclosis                                 X
Hemolysis                                          X           X
Protozoan Vacuole Contraction            X
Protozoan Hotility                       X
Phagocytosis by Alveolar Macrophages               X
Ami no Acid Transport                     X

-------
                            TABLE 29.   TEST ORGANISMS AND ORGANISMAL  LEVEL  OR  PARAMETER  EVALUATED
                                                Test organism
                                                                  Level  or  parameter
      Assays
         Other                Higher
Human  vertebrate  Protozoan  plant   Alga  Bacteria   Organising.!   Cellular  Qrcjanellar  Enzymatic
Acetylene Reduction
Hill Reaction
Greening
RuDP Carboxylase
  Activity
Photosynthetic Oxygen
  Evolut ion
Respiration in HeLa
  Cells
Adenylate Energy Charge
Cloning L929 Mouse Cells
Protozoan Clonal Viability
Human KB Cell Growth Rate
Human Embryonic Lung Fibro-
  blast (WI-38) Cytotoxicity
Mitogen Stimulation of
  Lymphocytes
Chick Embryo Development
Trypan Blue Dye Exclusion
  by Human KB Cells
RNA Polymerase Activity
Adenyl Cyclase Activity
Lysosomal Enzyme Release
Macromolocular Synthesis
  in KB Cells
Cyclosis
llemolysis
Protozoan Vacuole
  Contraction
Protozoan Moti1ity
Phagocytosis by Alveolar
  Macrophages
Ami no Acid Transport

-------
                                                          TABLE 30.  SPECIAL EQUIPMENT
                Assays
                                              Scintillation
Centrifuge   Microscope   Spectrophotonietcr	Counter
 Mammalian
cell  culture
 facilities
  Other
equipment
Acetylene Reduction
Hill Reaction
Greeninu
HuDP Carboxylase Activity
Photosynthetic Oxygen
  Evolution
Respiration in HeLa Cells
Adenylato Energy Charge
Cloning L9i!9 Mouse Cells
Protozoan Clonal Viability
Human (KB) Cell Growth Rate
Human Embryonic Lung Fibro-
  blast (WI-38) Cytotoxicity
Hitogen Stimulation of Lympho-
  cytes
Chick Embryo Development
Tryjian Blue Oye Exclusion  by
  Human Kli Cells
RNA Polymeraso Activity

Adenyl Cyclase Activity
Lysosomal Enzyme Release
Macromoleciilar Synthesis
  in KI3 Cells
Cyclosis
llemolysis
Protozoan Vacuole Contraction
Protozoan Hotility
Phagocytosis liy Alveolar
  Macrojihacjc's
Ami no Acid Transport
                                                                            Gas chromatograph



                                                                            Warburg apparatus

                                                                            Oxygen electrode




                                                                            llemocytometer

                                                                            Aniu:al rearing
                                                                            facilities
                                                                            Incubators, hatching and
                                                                               rearing facilities,
                                                                               sterile injecting
                                                                               facilities
                                                                            llemocytometer

                                                                            Mil 1 ipori> filtration
                                                                               manifold
                                                                            Microphotography  unit
                                                                            Animal  rearing  facilities

-------
                                                          Ji .   I ihi
                                                                                 LUil'ilLiAii SKILL


Assay
Acetylene Reduction
Hill Reaction
Oreening

RuOP Carboxylase Activity
Photosynthetic Oxygen
Evolution
Respiration in HeLa Cells
Adcnylatc Energy Charge
Cloning L929 Mouse Cells
Protozoan Clonal Viability
Human (KB) Cell Growth Rate
Hunan Embryonic Lung Fibro-
blast (WI-38) Cytotoxicity
Hitogen Stimulation of
lymphocytes


Chick Embryo Development


Trypan Blue Dye Exclusion
by Human (KB) Cells
UNA Polymerase Activity
Adenyl Cyclase Activity
Lysosouidl Enzyme Release
Macromolecular Synthesis in
KB Cells
Cyclosis
llemolysis
Protozoan Vacuole
Contraction
Protozoan Motility
Phagocytosis by Alveolar
Macrophages


Amino Acid Transport

Assay Set
time*, hours
2.5
3
29

2

50
30
8
244
148
75

27

76


720 (1 month)



30
1.5
29
29

34
30
2

17
23
27


29

Total assay set
fime**, hours
54
57
150

54

100
80
62
326
210
125

176

76


720



77
5
79
76

78
141
4

143
136
27


53
Total
technician Technician
timet, hours Skill t
12 ++
18 *
9 t

12 t++

84 ++
51 ++
23 +t
15 ++
14 t
12 ++

14 ++

11 +++


108 +



11 ++
5 t++
14 +++
9 ++

11 ++
58 + +
4 +

30 tt
27 ++
17 ++


11 +++
Other
(administrative)
time5, hours
8
11
8

8

11
13
9
9
9
8

9

8


11



8
8
9
8

8
11
8

10
9
9


8
Other Approximate
costs and total cost*.
consideration


$35 (greenhouse
fee)











$100 (animal
facility fee and
rearing
$150 (animal
facil ity fee and
rearing)







$30 (special algal
culture facilities)




$100 (animal
facil ity fee and
rearing)
	 .
$
620
820
560

750

2330
2350
920
750
660
620

730

820


2510



600
530
880
560

720
1810
440

1J30
1000
890


810
                                                                                                                                                              --J
                                                                                                                                                              en
•Three replicates of five chemical concentrations.
**Including cell growth, solution preparation, organelle or enzyme preparation, and data recording.
'''Including GLP, running assay, and solution preparation.
fHated from + (unskilled) to >n (highly skilled).
'Including Ph.D. supervision, managerial  time, data analysis, and reporting.
"costs are estimated for the purpose of comparison only.  Actual  costs may vary to 20 to 25 percent
 from these figures at different laboratories.

-------
                                  76
                        TABLE- 32.  DATA BASE AND COMMENTS
        Assay
Data base*
          Comments
Acetylene Reduction              ++
Hill Reaction                   +++

Greening                        +++

RuDP Carboxylase Activity        +
Photosynthetic Oxygen
  Evolution
Respiration in HeLa Cells
Adenylate Energy Charge          ++



Cloning L929 Mouse Cells         ++

Protozoan Clonal Viability       ++



Human  (KB) Cell Growth Rate      ++
Human Embryonic Lung Fibro-
  blast (WI-38) Cytotoxicity

Mitogen Stimulation of Lympho
  cytes
Chick Embryo Development
Trypan Blue Dye Exclusion by     +
  Human KB Cells

RNA Polymerase Activity          ++
Adenyl Cyclase Activity
                               very explosive.
                               activities
Acetylene gas is
Chloroplasts and
  vary
This assay has already been
used to test many chemicals.
This assay is rapid and rela-
  tively inexpensive, but
  activity varies.
Respiratory and photosynthe-
  tic rates may vary.
An extensive time and great
  cost are required to com-
  plete an assay set.
No chemical effects on this
  assay are known, but it
  measures a universal meta-
  bolic process.
A long time is required to
  complete an assay set.
A long time is required to
  complete an assay set,  but
  many assays can be per-
  formed simultaneously.
This assay has already had
  limited use as a toxicity
  screen.
Toxic chemical effects could
  be extrapolated to human
  pulmonary tissues.
A great expense is incurred in
  maintaining a mouse colony.
Extensive time and great  cost
  are required to complete an
  assay set.   There is no
  standardized endpoint.
Results from this assay can
  be extrapolated to all
  membranes.
Hundreds of assays can be
  completed daily and correl-
  ated to all  life forms.
It is difficult to correlate
  assay results with cellular
  or tissue toxicity.

-------
                                  77
                          TABLE 32.   (Continued)
        Assay
Data base*
Comments
Lysosomal Enzyme Release
Macromolecular Synthesis in      ++
  KB Cells
Cyclosis
Memolysis                       +++
Protozoan Vacuole Con-           +
  traction

Protozoan Motility               ++
Phagocytosis by Alveolar        +++
  Macrophages
Ami no Acid Transport             +
              Results  from this  assay  can
                be extrapolated  to  cellular
                and tissue levels.
              This assay  could be combined
                with RNA  polymerase activity
                to detect chemical  inhibition
                of RNA synthesis.
              This assay  has  little relevance
                to mammalian  cell and
                tissues.
              The assay is rapid, inexpen-
                sive,  and results can  be
                extrapolated  to  many systems.
              Results  may be  correlated to
                other  assays  involving
                protozoans.
              A long time and great expense
                is required to complete an
                assay  set.
              This assay  is already in limited
                use as a  toxicity screen.
              The results of  this assay can
                be extrapolated  to  other
                membranes.
*Rated +++ (good), ++ (fair), and + (poor).

-------
                                      78


                                  REFERENCES


Nitrogen Fixation


Hardy,  R.W.F.,  R. D.  Holsten,  E. K. Jackson,  and R. C.  Burns.   1968.   The
acetylene-ethylene assay  for N2 fixation:   Laboratory  and field  evaluation.
Plant Physio!., 43:1185-1207.

Rubinstein, R., E. Cuirle, and H. Cole.   1975.   Test methods  for assessing the
effects  of  chemicals   on  plants.    EPA 560/5-75-008.    U.S.   Environmental
Protection Agency, Office of Toxic Substances,  Washington D.C.,  246 pp.

Photosynthesis


Anderson, J. M., and N. K. Boardman.  1964.   Studies  on  the  greening  of dark-
grown bean plants.  Aust. J.  Biol. Sci.,  17:93-101.

Arnon,  D.  I.   1949.   Copper  enzymes  in  isolated  chloroplasts—Polyphenol-
oxidase in Beta vu7_gar1s_.  Plant Physiol., 24:1-15.

Borque, D.  P.,  P. N.  McMillan,  W.  J. Clingenpell, and  A.  W.  Nay!or.   1976.
Comparative  effects  of several  inhibitors  of chloroplast thylakoid  membrane
synthesis in greening jack bean.  Bot. Gaz., 137:279-284.

Brown,  R.  D.,  and R.  Haselkorn.   1972.   The  isolation of Euglena  gracilis
chloroplasts uncontaminated by nuclear DNA.   Biochim.  Biophys.  Acta,  259:1-4.

Goldthwaite,  J.   J.,   and  L.  Bogorad.    1971.   'A  one-step method  for  the
isolation  and  determination  of  leaf  ribulose-l,5-diphosphate  carboxylase.
Anal. Biochem., 41:57-66.

Hampp, R., K. Beulich,  and H.  Ziegler.   1975.   Effects  of zinc and cadmium on
photosynthetic   C02-fixation   and    Hill   activity   of   isolated   spinach
chlorplasts.  Z. Pflanzenphysiol., 77:336-344.

Hill, R. 1937.  Oxygen evolved by isolated chloroplasts.   Nature, 139:881-882.

Keller, C. J., and R.  C.  Huffaker.   1967.  Evidence for in vivo light-induced
synthesis of  ribulose  1,5-diphosphate carboxylase and phosphoribulokinase in
greening barley leaves.  Plant Physiol.,  42:1277-1283.

Kratky, B.  A.,  and  G.  F. Warren.  1971.   The use  of  three simple, rapid bio-
assays on forty-two herbicides.  Weed Res.,  11:257-262.

Margulies, M. M.  1962.  Effect of c.hloramphenicol  on light dependent develop-
ment of seedlings of Phaseolus vulgaris var.  Black valentine,  with particular
reference  to  development   of   photosynthetic  activity.    Plant  Physiol.,
37:473-480.

-------
                                      79


 Moreland,  D.  E., and K.  L.  Hill.   1962.   Interference of herbicides with the
 Hill  reaction  of  isolated chloroplasts.   Weeds, 10:229-236.

 Pratt,  L.  H.,  and N. I.  Bishop.   1968.  The  520  nm light-induced absorbance
 change  in  photosynthetic mutants of  Scenedesmus.    Biochem.  Biophys.  Acta.,
 162:369-379.

 Rubinstein, R., E. Cuirle, and H. Cole.   1975.  Test  methods for assessing the
 effects  of  chemicals  on plants.    EPA  560/5-75-008.   U.S.  Environmental
 Protection  Agency, Office of Toxic Substances, Washington D.C., 246 pp.

 Wald, G.,  J. Hopkins III, P.  Albersheim,  J. Dowling, and  0.  Denhardt.   1966.
 Twenty-six  Afternoons of Biology.    2nd  edition.   Addison-Wesley Publishing
 Co.,  Reading,  Massachusetts., pp. 59-60.

 Wolf, F.  T.   1977.   Effects  of  chemical  agents in  inhibition  of chlorophyll
 synthesis   and  chloroplast   development   in  higher  plants.     Bot.   Rev.,
 43:395-425.
Respiration


Bruening, G., R. Criddle, J. Preiss, and F. Rudert.  1970.  Electron transport
and  oxidative  phosphorylation.    In:    Biochemical  Experiments.    Wiley-
Interscience, New York., pp. 310-311.


High-Energy Phosphate Production


Atkinson, D. E.  1969.   Regulation  of  enzyme  function.   Ann.  Rev. Microbiol.,
23:47-68.

Atkinson,  D.  E.,  and G.  H.  Walton.   1967.   ATP conservation  in metabolic
regulation.     Rat   liver   citrate  cleavage   enzyme.     J.   Biol.   Chem.,
242:3239-3241.

Bostick, W. D., and  3.  S.  Ausmus.   1973.   Methodologies for the determination
of adenosine phosphates.  Anal. Biochem., 88:78-92.

Ching,  T. M.,  and  K. K.  Ching.   1972.   Content of adenosine  phosphates and
adenylate energy charge  in  germinating  ponderosa pine  seeds.   Plant Physiol.,
50:536-540.

Nannipieri,  P., R.   L.  Johnson,  and  E.  A.   Paul.    1978.    Criteria  for
measurement of  microbial growth and activity  in soil.   Soil  Biol. Biochem.,
10:223-229.

-------
                                      80
Growth and Cell Division
Baiile, M.,  and  R.  Hardegree.   1970.   A cell  culture  assay to evaluate  the
toxicity of Aracil A. Proc. Soc. Exp.  Biol.  Med.,  133:222-228.

Corning D.,  and J.  Firth.   1969.   Toxicity  of polyproyline in  tissue culture.
Fd. Cosmet. Toxicol., 7:461-472.

Duke,  K.  M.,  M.  E.  Davis,  and A.  J. Dennis.   1977.    IERL-RTP  Procedures
Manual:    Level   I  environmental  assessment:    Biological  tests  for  pilot
studies.   EPA-600/7-77043.   U.S.  Environmental Protection Agency, Office  of
Research and Development, Washington D.C., 106 pp.

Feldman, G.  L.,  T.  M.  Ferguson,  R.  H. Ridgan, B.  L.  Reed, M. S.  Cross,  and
J. R. Crouch.  1958.  Effect of dinitrophenol on  hens of chick  embryo.   Proc.
Soc. Exp. Biol. Med., 98:646-648.

Flick, D. F., D.  Firestone, J. Ress,  and J.  R. Allen.   1973.  Studies of chick
edema factor 10.   Tox-icity of chick edema factors in the chick, chick embryo,
and monkey.  Poultry Sci., 52:1637-1641.

Gardiono,  E.,  M.. Crerar  and  R. E.  Pearlman.  1973.   Growth and  cloning  of
Tetrahymena pyrifonnis on solid medium.  J.  Bacteriol.,  116:1170-1176.

Gebhardt, D. 0.  E., and M. J.  Van Logten.    1968.  The chick  embryo  test  as
used in the study of the toxicity of certain dithiocarbamates.   Toxicol. Appl.
Pharmacol., 13:316-324.

Hall, B. K.  1972.   Skeletal  defects  in embryonic chicks  induced  by adminis-
tration of beta-aminopropionitrile.  Teratology, 5:81-88.

Hall, B. K.  1976.  Thallium-induced achondroplasia  in  chicken  embryos and the
concept of critical  periods during development.   Teratology, 15:1-6.

Heaf, D. P., and D.  Lee.  1971.   A viability assay for  Tetrahymena pyriformis.
J. Gen. Microbiol.,  68:249-251.

Hulbert,  S.  F.,  and J.  J.  Klawitter.    1974.   A quick  screening  test  of
biomaterials by  means of chick  embryo techniques.   J. Biomed. Mater.  Res.,
8:137-153.

Kury,  G.,  and R.  J. Crosby.    1968.   Studies on  the development  of chick
embryos exposed to cobaltous chloride.  Toxicol. Appl.  Pharmacol.,  13:199-206.

Lee, H., and G.  W.  Kalmus.   1978.   The differential  susceptibility  of early
chick embryos to 5-biomodeoxyuridine.  Experientia,  34:278-281.

Loomis, T. A.  1978.  Toxicologic testing methods.  Chapter 13 in:   Essentials
of Toxicology.   By T. A. Loomis, Lea Ferbiger, Philadelphia, pp. 214-215.

-------
                                      81
 Lowry,  0.  H.,  N.  J.  Rosebrough,  A.  L.  Farr,  and R. J. Randall.  1951.  Protein
 measurement  with  the Folin  phenol  reagent.   J. Biol. Chem., 193:265-275.

 Mclaughlin,  J. Jr., J. P.  Marliac,  M.  J.  Verrett, M. K.  Mutchler,  and  0. G.
 Fitzhugh.  1963.   The injection  of chemicals into  the yolk sac of fertile  eggs
 prior   to  incubation  as  toxicity  test.     Toxicol.  and Appl.  Pharmacol.,
 5:760-771.

 Messier,  P.  E.  1973.  Effects of LSD on the  development, histology, and  fine
 structure  of the  chick embryo.  Toxicol. Appl. Pharmacol., 25:54-59.

 Mouton, R.,  and B.  Hendrickx.  1974.  Cloning  of Tetrahymena pyriformis within
 gelatin agar dishes.  Tetrahymena  News, 2, No. 6.

 Oyama,  V., and H. Eagle.   1956.   Measurement  of growth  in tissue culture  with
 a  phenol reagent.   Proc. Soc. Exp. Biol. Med., 91:305-307.

 Pagnini, G., R. DiCarlo,  and G.  V.  Pelagalli.   1972.   Comparative evaluation
 of the  influence  of some  tetracyclines  on  chick  embryo.   Toxicol.  Appl.
 Pharmacol.,  22:427-431.

 Palmer, I. S., R. L. Arnold, and  C. W. Carson.   1973.    Toxicity  of various
 selenium derivatives  to chick embryos.  Poultry Sci., 52:1841-1846.

 Persoone,  G.,  and  D. Dive.   1978.   Toxicity  tests  on  ciliates  - A  short
 review.  Ecotox.  Envir. Safety, 2:105-114.

 Richardson,  D., T. C. Dorris, S.  Burks, R. H.  Brov/ne, M. L. Higgins, and F. R.
 Leach.  1977.   Evaluation  of a  cell culture assay for determination of water
 quality of oil-refinery effluents.   Bull Env.  Contam. Toxicol., 18:683-690.

 Save!,  H.,  B.  Forsyth,  W.  Schaeffer,  and  T. Cordelia.   1970.    Effect of
 aflatoxin B  upon  phytohemaglutinin-transformed human lymphocytes.   Proc.  Soc.
 Exp. Biol. Med.,  134:1112-1115.

 Swartz, W. J.   1977.   Effect of  different methods of  exposure to cyproterone
 acetate on mortality  in chick embryos.  Experientia, 33:1256-1257.

 West, R. A.,  P.  W. Barbera, J.  R. Kolar, and  C. B.  Murrell.   1962.   The  agar
methods for  determining the  activity of diverse  materials  against  selected
 protozoa.   J.  Protozool., 9:65-73.

Zagris, N.,  and J.  G. Georgatsos.   1977.  Applications  of chemicals in early
 chick embryos  in ova:  A precaution.  Experientia., 33:1225-1256.


Catalysis  (Enzymatic Activities)


Carr, J.,  and  M.  Ligaton.   1973.  Hexachlorophene-induced alterations  in the
metabolism  of  cultured  human   lung cells.    Proc.  Soc. Exp.  Biol.  Med.,
142:564-568.

-------
                                     82


Glazer, R.  I.    1978.   Comparisons  of  the fidelity  of  transcription of RNA
polymerase. I  and  II  following  N-hydroxy-2-acetylaminofluorene  treatment.
Nucleic Acids Res., 5:2607-2616.

Grasso, P.,  J.  Gaydon,  and R.  Hendry.    1973.    The safety  and  testing  of
medical plastics II.   An  assessment  of  lysosomal  changes  as  an  index  of
toxicity in cell cultures.  Fd.  Cosmet.  Toxicol.,  11:255-263.

Hoffman, D.  J.,  and S.  K.  Niyogi.    1977.   Metal  mutagens  and  carcinogens
affect RNA synthesis rates in a  distinct  manner.   Science,  198:513-514.

Jendrisak,  J. J., and R. R.  Burgess.   1975.  A new method  for  the  large-scale
purification of wheat  germ  DNA-dependent RNA polymerase  II.    Biochemistry,
14:4639-4645.

Klein,  I.,  L.  Moore, and I.  Pastan.   1978.   Effect  of liposomes containing
cholesterol  on  adenylate  cyclase activity of cultured mammalian fibroblasts.
biochim. Biophys. Acta, 506:42-53.

Polya, G.  M. 1973.  Transcription.   In:  The R'ibonucleic Acids,  P. R.  Stewart
and D. S.  Letham (Eds.), Springer-Verlag, New  York, pp.  7-36.


Other Cellular Processes
Allen, J.  E.,  and H.  Rasmussen.   1971.  Human  red  blood  cells:  Prostaglandin
£2,   epinephrine   and   isoproterenol    alter    deformability.       Science,
174:512-514.

Andrivon,  C.   1968.   L'inhibition des  mouvements  ciliaires chez  Paramecium
caudatum par  les  sels de  nickel:  Sa levee  par les  complexants  de cet  ion.
Protistologica, 4:517-523.

Andrivon,  C.   1972.   The  stopping of  ciliary movement  by nickel salts  in
Paramecium  caudatum.    The   antagonisms   of  K+   and   Ca2+  ions.     Acta
Protozool., 11:373-386.

Bergquist, B. L., and  E. C. Bovee.   1973.   Some adverse  effects  of cadmium on
growth and locomotion of Tetrahymena pyriformis. J.  Protozool., 20:497.

Bergquist,  B.  L., and E.  C.  Bovee.   1974.   A rapid method for  monitoring
detrimental effects of chemicals  on protozoan locomotor rates. J.  Protozool.,
21:439.

Dry!, S.,  and  K.  Bujwid-Cwik.   1972.   Effects  of detergents on  excitability
and motor response in protozoa.   Acta Protozool., 11:367.

Duke,  K.  M.,  M.  E.  Davis,  and  A.  J.   Dennis.   1977.    IERL-RTP  Procedures
Manual: Level I environmental  assessment:  Biological tests for  pilot studies.
EPA-600/7-77043.   U.S. Environmental Protection Agency, Office of Research and
Development, Washington D.C.,  106 pp.

-------
                                      83


 Geis,  J.  W., and J.  L.  Morrison.   1971.   An Illustrated Study Guide to Plant
 Biology.   Burgess Publishing Co.,  pp. 27-30.

 Green,  G.,  and  D. Carolin.  1967.   The  depressant effect of cigarette smoke on
 the in  vitro  antibacterial   activity  of  macrophages.    New  Eng.  J.  Med.,
 276:421-427.

 Itano,  H. A., D. W. Hollister, W.  M.  Fogarty,  and S.  Manner.   1974.  Effect of
 ring  substitution on  the hemolytic  activity  of arylhydrazines.   Proc.  Soc.
 Exp. Biol.  Med., 147:656-658.

 Klebanoff,  S.  J.,  and  R.  A.  Clark.   1975.   Hemolysis  and  iodination  of
 erythrocyte  components  by   a   myeloperoxidase-mediated  system.     Blood,
 45:699-708.

 Lessler, M. A., and M.  I. Walter.   1973.  Erythrocyte osmotic fragility in the
 presence of lead or mercury.  Proc. Soc. Exp. Biol. Med., 142:548-553.

 Light,  W. G.,  and E.  T. Wei.   1977.  Surface charge and hemolytic activity of
 asbestos.   Environ. Res., 13:135-145.

 Lucas,  W.   J.    1977.    Plasmalemma  transport  of  HCC>3~  and  OH"  in  Chara
 corallina:   Inhibitory  effect  of   ammonium   sulfate.     Jour.  Exp.   Bot.,
 28:1307-1320.

 Luthra, M.  G.,  J. E.  Ekholm,  H.  D. Kim, and D. J. Hanahan.   1975.  Effects of
 Tris and histidine on  human erythrocytes and conditions influencing their mode
 of  action.  Biochim. Biophys. Acta, 382:634-649.

 Majer,  H.   1975.   Stabilization of  rat  erythrocytes against  the  haemolytic
 effect  on glass particles.  Agents Actions, 5:161-163.

 Matthews.  R.,  C. Leslie,  and P.  Schalefield.    1970.   Histidine  uptake and
 exchange in $37 oscites tumor cells.  Biochim. Biophs. Acta, 203:457-463.

 Nilsson, J. R.   1974.   Effects  of  DMSO  on  vacuole formation,  contractile
 vacuole function, and  nuclear  division  in  Tetrahymena pyriformis GL.   J. Cell
 Sci., 16:39-47.

 Patterson,  D.  J.,  and M. A.  Sleigh.   1976.   Behavior  of   the  contractile
 vacuole of  Tetrahymena pyriformis  W:  A  redescription  with  comments  on the
terminology. J. Protozool, 23:410-417.

Perkins, D.  L., and L.  S.  Ciereszko.  1973.   The environmental toxicity  of
crass in  acetate using Tetrahymena  pyriformis  as  a  model.    Hydrobiologia,
42:77-84.

Pesh-Iman,  M.,  R. J.   Willis,  and  R.  0. Recknagel.   1978.   Red cell  damage
 induced  by  peroxidized  microsomes;     The  relationship  between  hemolytic
activity and peroxide content.   J.  Environ. Sci. Health,  13:81-95.

-------
                                     84
Pfeffer, W.  1938.  The  Physiology  of  Plants:   A  treatise  upon the metabolism
and sources of energy in plants.   Oxford,  The Clarendon  Press, pp. 283-293.

Rifkin,  J.  L.    1973.    The  role  of  the  contractile  vacuole   in  the
osmoregulation of Tetrahymena pyriformis.   J.  Protozool,  20:108-114.

Sheets, R. F.,  H.  E.  Hamilton, and E.  L.  DeGowin.  1956.  Hemolysis  of  human
erythrocytes by  a  sulfhydryl  inhibitor-p-chloromercuribenzoic  acid.    Proc.
Soc. Exp.  Biol. Med., 91:423-427.

Summerton, J., S. Hoenig, C. Butler, and  M.  Chvapil.  1977.  The  mechanism  of
hemolysis by silica and its  bearing on  silicocis.  Exp. Mol. Path., 26:113-128.

Thaine, R.   1964.   The  protoplasmic  theory of phloem  transport. Jour.  Exp.
Bot., 15:470-484.

Zaslavsky,  B.   Yu.,  N.  N.  Ossipov, and  S.  V. Rogozhin.   1978.  Action  of
surface-active substances on biological membranes  III. Comparison  of  hemolytic
activity   of   ionic  and  nonionic  surfactants.    Biochim.  Biophys.   Acta,
510:151-159.
General Reference
Woodard, G.   1976.   Draft survey  and evaluation of  in vitro toxicity  test
methods, EPA  560/5-75-007.   U.S. Environmental  Protection  Agency, Office  of
Toxic Substances, Washington,  D.C.,  110 pp.

-------
         APPENDIX



LITERATURE SEARCH METHODS

-------
                                     A-l

                                   APPENDIX

                          LITERATURE SEARCH METHODS

LITERATURE SEARCH

            To obtain information  on  physiological  assay  methods  and on  the
effects of  potential toxicants on  these assays, manual  literature  searches of
published articles,  reviews,  abstracts,  and  bibliographies  as  well  as  com-
puterized searches  of selected  data  bases were  conducted.   This  literature
search was  conducted  over  a period of 6 weeks  from  May 7, 1979, to  June 15,
1979, by the methods outlined in Van Voris, et al  (1979).

Hand Searches

          In the hand literature searches,  50 of the  most  widely used and sub-
scribed journals in biochemistry, molecular biology,  enzyrnology, cell  biology,
pharmacology,  botany, zoology,  toxicology,  ecology,   and microbiology  were
scanned over  the  past year (May, 1978-April, 1979) for references  pertaining
to  rapid  physiological   toxicity  assays  (Table A-l).   Additional  references
were located  by reviewing the abstract and bibliographic  publications Biblio-
graphy  of  Agriculture,  Environmental Abstracts, Biological  Abstracts,  and
Chemical Abstracts.   These bibliographic  publications were  searched over  a
5-year period (usually 1974-1979).
          The applicability of the  indexed  articles was based upon  the titles
only, or the  abstracts when available.  In many instances it was necessary to
make  subjective  decisions  as  to  whether  an article  pertained  to  in  vitro
physiological assays, particularly when  abstracts were not  available.   Addi-
tional  references  were   reviewed on the  basis  of bibliographic citations in
individual  papers.   Several articles familiar  to the  authors  of  this report
were also reviewed.

-------
                                     A-2

 Computer Searches

           Computer searches were conducted  on  data bases simultaneously with
 the hand  searches.    The  rationale of  the  data  bases selected was  to give
 coverage to  all  types  of  literature reporting  ecological  effects  of toxic
 chemicals.   The bases  searched were:
          •   Bioscience  Information  System  (BIOSIS)   which  focuses  on  life
             sciences  worldwide  since  1964.    The  data  base is  journal  pub-
             lications  containing  the  entire  life   sciences  and  including
             microbiology,  plant  and  animal  sciences  experimental  medicine,
             agriculture, pharmacology,  ecology, bioengineering, biochemistry,
             and biophysics.   The producer is BioSciences Information Service
             of  Biological Abstracts.
          •   Toxicology Information  On-line   (TOXLINE)  which  gives  worldwide
             coverage to  toxicology  studies on  animals  and  humans  since 1971.
             The data   base  includes  toxicology  studies  on  environmental
             pollutants and  chemicals,  adverse drug reactions,  and other toxic
             materials.   It  is produced by  the National Library of Medicine.
          BIOSIS, searched  from  1969 to the  present,  printed only titles.   We
 found  this  data  base  to  be  particularly useful  because  it  has  controlled
 vocabularies  with articles referenced by both key words and topics (e.g., Hill
 reaction  and photosynthesis)  so that  all  references  pertaining  to  a desired
 subject  under a topic  are printed.   TOXLINE  was the  more  comprehensive data
 base (searched  since 1971), overlapping somewhat with BIOSIS.
            The information retrieved  from computer searches  is  dependent  on
 words  entered into  the computer by the user  as well  as the key word descrip-
 tors used by  authors  or  reviewers  of articles  used  in  the  different  data
 bases.    In many cases, the key  words used by a reviewer omit important facets
 of  the  article or refer  to  lightly  covered  topics  because of  misleading
 titles.   The key words  to  be entered  in  the  computer by  the searchers v/ere
 determined by assay title, test organism,  and cellular  processes  involved.
Key words  (assays,  organism,  and processes)  were taken from  Table  2  of this
 report.    For  example,  for  protozoan  vacuole  contraction,   the  key  words
protozoan and contractile  vacuole were among those entered in  the  computer.
Articles that  appeared relevant  were  then reviewed and  specific  information
was extracted from them.

-------
                                     A-3
              TABLE A-l.  JOURNALS SCANNED  IN  LITERATURE  SEARCH
Agricultural and Biological  Chemistry

Analytical Biochemistry

Annual Review of Microbiology

Applied and Environmental
  Microbiology

Biochemical and Biophysical  Research
  Communications

The Biochemical Journal

Biochemistry

Biochimica et Biophysica Acta (Nucleic
  Acids, Enzymology, Reviews on Cancer,
  Lipids, Bioenergetics)

Botanical Gazette

Botanical Review

Canadian Journal of Biochemistry

Carbohydrate Research

Cell

Developmental Biology

Ecology

Ecotoxicology and Environmental Safety

Environmental Science and Technology

European Journal of Biochemistry

Experimental Cell Biology

Experimental Cell Science

Experientia
FEES Journal

Food and Cosmetics
  Toxicology

Histochemistry and Cyto-
  chemistry

Journal of Bacteriology

Journal of Biological
  Chemistry

Journal of Cell Biology

Journal of Cell Science

Journal of Cellular
  Physiology

Journal of Experimental
  Botany

Journal of General Micro-
  biology

Journal of Molecular
  Biology

Journal of Protozoology

Methods in Enzymology

Molecular and General
  Genetics

Molecular Pharmacology

Nature

Nucleic Acids Research

Parasitology

Pesticide Biochemistry
  and Physiology

-------
                                     A-4
                           TABLE A-l.  (Continued)
Physiologia Plantarum
Plant Physiology
Plant Science Letters
Planta
Proceedings of the National Academy
  of Science
Proceedings of the Society for
  Experimental Biology and
  Medicine
Sabouraudia
Science
Toxicology and Applied
  Pharmacology
Virology
Weeds

-------
                                     A-5
                                  REFERENCE
Van  Voris,  P.,   S.   Pomeroy,  H.  Grotta,  and  A.   Rudolph.    March,   1979.
Literature Evaluation of Field-Observed Effects of Toxic Chemicals.  OPTS/EPA
Contract No.  68-01-5043.  27 pp.

-------
                                   TECHNICAL REPORT DATA
                            (Please read Instructions on ihe reverse before completing)
1. REPORT NO.

  EPA-560/11-80-001
                              2.
                                                     3. RECIPIENT'S ACCESSION NO.
4. TITLE AND SUBTITLE
      Identification and Evaluation  of Potential
        Physiological Toxicity Assays
                                                     5. REPORT DATE
                                                         February  1980
                                                     6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
                                                            8. PERFORMING ORGANIZATION REPORT NO.
  G.  H.  Kidd,  J. M. Rice, M.  E.  Davis,  M.  A.  Hurst,
  M.  F.  Arthur, S. E. Pomeroy, and  M.  L.  Price
9. PERFORMING ORGANIZATION NAME AND ADDRESS
  Battelle-Columbus Laboratories
  505  King  Avenue
  Columbus,  OH  43201
                                                            10. PROGRAM ELEMENT NO.
                                                      11. CONTRACT/GRANT NO.
                                                               68-01-5043
12. SPONSORING AGENCY NAME AND ADDRESS
  EPA,  Office of Pesticides  and Toxic Substances
  401 M Street, S. W.
  Washington, D.C.  20460
                                                      13. TYPE OF REPORT AND PERIOD COVERED
                                                       Final  Report:  4/79 - 2/80
                                                      14. SPONSORING AGENCY CODE
                                                              EPA-560/H
15. SUPPLEMENTARY NOTES
  EPA
i_ civic IN i Mn T r*u \ co

project officer for this report  is  Ronald A.  Stanley
16. ABSTRACT


  Battelle's  Columbus Laboratories  has  contracted with the Office  of Pesticides and
  Toxic  Substances, U.S. Environmental  Protection Agency, to  develop a list of
  physiological  assays as potential  toxicity screening tests  and to assess the
  strengths and  weaknesses of these assays.   After an extensive literature search,
  Battelle has compiled a list of 24 assays, covering seven physiological cate-
  gories  cited by OPTS/EPA.  Those  categories included nitrogen fixation, photo-
  synthesis,  respiration, high-energy phosphate production, growth and cell div-
  ision,  catalysis, and other cellular  processes.  Brief descriptions of assay
  methods and tables containing  critiques of each assay are presented along with
  literature  references for all  of  the  assays.   Assays that are simple, rapid,
  cost-effective, reproducible,  and well-documented are highlighted.
17.
                                KEY WORDS AND DOCUMENT ANALYSIS
                  DESCRIPTORS
                                               b.IDENTIFIERS/OPEN ENDED TERMS
                                                                    t.  COSATI Field/Group
  Analyzing/Assessing
  Bioassay
  Physiological/Cellular Toxicity
                                           Physiological Toxicity
                                             Tests
                                           Biological Toxicity
                                           Cellular and Subcell-
                                             ular Mechanisms  of
                                             Toxicity
18. DISTRIBUTION STATEMENT


            Unlimited
                                         19. SECURITY CLASS (This Kcportj
                                             Unclassified
21. NO. OF PAGES

     93
                                         20. SECURITY CLASS (Timpage)

                                             Unclassified
                                                                    22. PRICE
EPA Form 2220-1 (R»». 4-77)    PREVIOUS EDITION is OBSOLETE

-------