DOE

EPA
Department
of
Energy
Lawrence Livermore Laboratory
University of California
Livermore CA 94550
     UCRL-81690, Rev. 2
United States
Environmental Protection
Agency
Office of Energy, Minerals, and
Industry
Washington DC 20460
EPA-600/7-79-172
August 1979
            Research and Development
            Estimating the
            Potency of
            Mutagens
            Cytotoxicity  as an
            Obligatory
            Consequence of
            Mutagenicity
            Interagency
            Energy/Environment
            R&D  Program
            Report

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                RESEARCH REPORTING SERIES

Research reports of the Office of Research and Development, U.S. Environmental
Protection Agency, have been grouped into nine series. These nine broad cate-
gories were established to facilitate further development and application of en-
vironmental technology. Elimination of traditional grouping was consciously
planned to foster technology transfer and a maximum interface in related fields.
The nine series are:

      1.  Environmental Health  Effects Research
      2.  Environmental Protection Technology
      3.  Ecological Research
      4.  Environmental Monitoring
      5.  Socioeconomic Environmental  Studies
      6.  Scientific and Technical Assessment Reports (STAR)
      7.  Interagency Energy-Environment Research and Development
      8.  "Special" Reports
      9.  Miscellaneous Reports

This report has been assigned to the INTERAGENCY ENERGY-ENVIRONMENT
RESEARCH AND DEVELOPMENT series. Reports in this series result from the
effort funded under the 17-agency Federal Energy/Environment Research and
Development Program. These studies relate to EPA's mission to protect the public
health and welfare from adverse effects of pollutants associated with energy sys-
tems. The goal of the Program is to assure the rapid  development of domestic
energy supplies in an environmentally-compatible manner by providing the nec-
essary environmental data and control technology. Investigations include analy-
ses of the transport of energy-related pollutants and their health and ecological
effects; assessments of, and  development of,  control technologies for  energy
systems; and integrated assessments of a wide range of energy-related environ-
mental issues.
This document is available to the public through the National Technical Informa-
tion Service, Springfield, Virginia 22161.

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                                                        EPA-600/7-79-172
                                                        August,  1979
                      ESTIMATING THE POTENCY OF MUTAGENS
          Cytotoxicity as an Obligatory Consequence of Mutagenicity
                                      by
         June H. Carver, Elbert W. Branscomb, and Frederick T. Hatch
                         Biomedical Sciences Division
                        Lawrence Livermore Laboratory
                           University of California
                         Livermore, California  94550
               Department of Energy Contract No. W-7405-ENG-48
                          EPA-IAG-D5-E681-AN and AO
U.S. D.O.E. PROJECT DIRECTOR
U.S. E.P.A. PROJECT OFFICER
G. Stapleton
Office of Health Effects Research
Asst. Sec. for Environment
U.S. Dept. of Energy
Washington, D.C. . 20545
G. Rausa
Office of Energy, Minerals and
  Industry
U.S. Env. Prot. Agency
Washington, D.C.  20460

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                                  DISCLAIMER

    This report has been reviewed by the Lawrence Livermore Laboratory, the
U.S. Department of Energy, and the 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.
                                       ii

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                                   FOREWORD

    Short-term toxicologic testing, particularly methods for detecting
genetically active substances, has become a keystone of the Environmental
Protection Agency's efforts to detect and evaluate environmental hazards.
Among the most serious hazards to man's future are agents that damage the
genome, which is the information bank of cells and organisms, by mechanisms
that can increase the future population load of inherited structural defects
and genetic diseases or that can increase the incidence of cancer in the
current generation.  Tests for environmental mutagens play a dual role by
virtue of their ability to detect mutagens and their presumptive ability to
detect carcinogens, owing to abundant laboratory evidence that most known
carcinogens respond positively to tests for mutagens.

    The Biomedical Sciences Division of the Lawrence Livermore Laboratory
has for the past five years been heavily engaged in the development and
application of short-term tests for genetic toxicology.  Specific examples
are as follows:

  • basic studies of classes of mutations in mammalian cells in culture and
    methods for selective recovery of mutant cells;

  • development of suitable strains of cells for detection of forward
    mutations at multiple loci, and of detailed experimental protocols for
    mutagen detection;

  • development and application of multiple modes of testing _iri vitro and ^ji
    vivo for chromosomal damage and misrepair in the form of sister
    chromatid exchange, together with simultaneous correlation with mutation
    induction;

  • development and application of highly sensitive tests for injury to
    sperm cells in the male testis and to oocytes in the juvenile female
    ovary;

  • development of automated cytochemical methods for detection of rare
    events of mutation and malignant transformation of cells in living
    animals, including man;

  • application of cytogenetic and automated cytopathologic methods to
    workforce populations engaged with energy technology, and
                                      lii

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  • in collaboration with our Environmental Sciences Division, application
    of a battery of the foregoing short-term tests to complex effluents from
    coal gasification and oil shale retorting technologies.

    The following report represents an analysis of quantitative data on
cytotoxicity and mutation induction in mammalian cultured cell systems for
our laboratory and a review of the literature.  The analysis revealed that
the cytotoxic potency of 22 chemical mutagens is linearly correlated to a
high degree with their mutagenic potency in five rodent and human cell
systems.  This relationship indicates that the potential mutagenic potency
of chemicals can be reliably estimated from assays for their cytotoxicity.
Since the latter assays are rapid and relatively inexpensive, they are
suggested for wide application to screening of, for example, industrial
chemicals for potential genetic toxicity as a precursor to setting
priorities for further testing.  Thus, a substance exhibiting high toxicity
(i.e., killing efficiency) for mammalian cells would be given priority for
mutagenesis and other genetic toxicology assays.  A substance exhibiting low
cytotoxicity could be, at most, a weak mutagen and would have a lower
urgency for further testing.
                                       Mortimer L. Mendelsohn, M.D., Ph.D.
                                       Associate Director for Biomedical and
                                         Environmental Research
                                       Lawrence Livermore Laboratory
                                       iv

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                                   ABSTRACT

    Rapid and reliable screening methods are required for identifying
environmental mutagens and estimating their mutagenic potency in preparation
for use of more elaborate tests to assess the genetic risk to man.  In this
report, we show that the cytotoxic potency of 22 chemical mutagens is highly
correlated with their mutagenic potency as assayed in five rodent and human
in vitro cell systems.  This relationship implies that the maximum potential
mutagenic potency of such compounds may be reliably estimated from rapid and
straight-forward measurements of their cytotoxic potency, the latter defined
as the failure of cultured cells to undergo continued cell division.

    This report was submitted by the Lawrence Livermore Laboratory  (Dept. of
Energy, Contract No. W-7405-ENG-48) in partial fulfillment of Interagency
Agreements IAG-D5-E681-AN and AO under the sponsorship of the U.S.
Environmental Protection Agency.  This report covers a period from January,
1978 to January, 1979; work is still ongoing.

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                                    CONTENTS

Foreword	    iii
Abstract	      v
Contents	     vi
List of Figures	    vii
List of Tables	    vii

   1.  Introduction	      1
   2.  Discussion	      2

References	      9
                                      vi

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                                    FIGURES

Number

    1    The relationship between induced  mutation  frequency  per
         viable cell per unit exposure dose and the reciprocal of
         D37(M), i.e., the dose required to kill 63% of  the
         initial cell population	
    2a   The induced mutation frequency per viable cell calculated
         for the 0-37 exposure dose of 22 chemicals mutagens,  plus
         ultraviolet and ionizing radiation	   7
                                    TABLES

Number                                                                    Page

    1    Compounds evaluated for mutagenic potency	  3
                                      vii

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                                  SECTION  1

                                 INTRODUCTION

    A variety of short-term mutagenesis assays employing both procaryotic
and eucaryotic systems are being used to identify potentially hazardous
agents in the environment.  At present, the screening of a large number of
compounds is most effectively done with in vitro mutagenesis assays, of
which the main types use either bacterial or mammalian cells.  Although
tests with mammalian cells are not as rapid and inexpensive as microbial
assays, they are needed to confirm and extend the bacterial results.
Indeed, because of known differences in genome organization and possible
differences in metabolic and repair processes, mutagenicity assays using
mammalian cells may provide a better assessment of potential risk to humans
than do microbial tests.  It would be desirable to screen all potential
mutagens with mammalian cell mutagenicity assays, but this does not seem
feasible unless, as we propose, test compounds are first prescreened on the
basis of their cytotoxic potency.

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                                  SECTION 2

                                  DISCUSSION

    On theoretical grounds, one expects a certain minimum cytotoxic potency
to correlate with mutagenic potency, particularly when the latter is
measured using forward mutations that result in inactive gene products.  In
fact, since cells cannot divide unless a substantial fraction of their
genome is functionally intact, mutagenic agents should be obligatory
cytotoxic agents as well, with a given mutagenicity conferring a certain
irreducible cytotoxicity.  Thus, assays of cytotoxic potency, which are
relatively easy to perform with mammalian cells, might provide a reliable
estimate of an agent's maximum potential mutagenic potency.  The estimate is
necessarily a maximum one, since an agent may exert cytotoxic effects by
pathways independent of its mutagenic action.

    A correlation between cell survival and mutagenic response has been
noted for ionizing radiation mutagenesis^ and appears to be applicable to
ultraviolet radiation and certain chemicals as W6112-4.  Roberts e± al.
have discussed the molecular aspects of cellular lethality and mutagenesis
in terms of damage to DNA5.  To further test this relationship, we have
compiled data on the cytotoxicity and mutagenicity of the 24 chemical and
physical mutagens listed in Table 1.  As the measure of cytotoxic potency,
we have chosen to use the 037 unit of survival, defined here as the dose
required to kill approximately 63% of the initial cell population.  Unlike
DQ, estimation of 037 is usually possible from the limited survival data
that accompanies published mutation frequencies; 037 generally measures
survival within the linear portion of the dose response for mutation  (lower
survivals are frequently out of the linear mutation range).  Moreover, this
parameter reflects differences in repair capability or fidelity that may
influence both toxicity and mutagenicity.

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                 Table 1  Compounds evaluated for mutagenic potency
Compound                                                na     Ref.

Alkylating agents

  Streptozotocin  (SZ)                                    1     16
  Dimethylnitrosamine (DMN)                              2     22,30
  Ethyl methanesulfonate  (EMS)                          15     6,10,11,12,14
                                                               15,25,27,28,34,41
  Diethylsulfate  (DES)                                   1     9
  N-methyl-N'-nitro-N-nitrosoguanidine  (MNNG)           13     6,8,12,16,17,20
                                                               24,26,33,38,39
  N-methyl-N-nitrosourea  (MNU)                           2     8,39
  N-ethyl-N-nitrosourea  (EMU)                            1     8
  2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide  (AF-2)       2     26,35
  N-ethyl-N'-nitro-N-nitrosoguanidine  (ENNG)             1     8
  N-butyl-N-nitrosourea  (BNU)                            1     8
  Methyl methanesulfonate  (MMS)                          2     9,29
  Dimethylsulfate (DMS)                                   1     9

Polycyclic aromatic hydrocarbons  (PAH)

  Benzo(a)pyrene, diol epoxide  (BPde)                    1     23
  3-methylcholanthrene (MC)                              2     21
  Benzo(a)pyrene  (BP)                                    3     19,21
  7,12-dimethylbenz(a)anthracene  (DMBA)                  2     21
  7,bromomethylbenz(a)anthracene  (MBA-7br)               1     18
  7,12-dimethylbenz(a)anthracene, 5,6-oxide  (DMBAox)     1     36
  Dibenz(a,h)anthracene,  5,6-oxide  (DBAox)               1     36
  Benzo(a)pyrene, 4,5-oxide  (BPox)                       1     36

Frameshift mutagens

  Heterocyclic nitrogen mustard compounds  (iCR's)        5     13,39

Physical mutagens

  X- and  -irradiation                                   4     1,5,7,31,32
  Ultraviolet irradiation  (UV)                           6     10,12,15,25,
                                                               37,40

Miscellaneous

  4-nitroquinoline-l-oxide  (NQO)                         4     6

aNumber of determinations evaluated for each compound  (some at multiple  genetic
  loci).

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    In Fig. 1, we compare the frequency of forward mutations induced per
applied dose with the reciprocal of the molar dose required for 037
survival in three rodent and two human cell systems5~41>  ^s plotted, the
data constitute a potency index, extending from weakly mutagenic and less
toxic compounds to highly mutagenic agents that are toxic at very low
concentrations.  The relative increase in cytotoxicity is accompanied by a
proportional increase in mutagenicity, i.e., the slope of the regression
relationship is 1.03 j+ 0.03.  The observed correlation between cytotoxicity
and mutagenicity suggests that a determination of the D37 dose of toxic
agents can be used to estimate the maximum potential induced mutation
frequency.  In particular, these data permit the hypothesis that no agents
will be found whose location on this graph is significantly above the upper
dotted line.  Whereas mutagenicity and cytotoxicity separately range over
six orders of magnitude, no agent can induce more than approximately one
forward mutation at a given locus per one hundred cells surviving at the
037 dose.  If this hypothesis is valid, this is a biological limit to
mutagenic potency that is demonstrated by compounds whose cytotoxicity is
due solely to mutational events.

    On the other hand, we believe the absence of points below the lower
dotted line to be artifactual, representing the bias of reported mutagenesis
studies for compounds whose ratio of mutagenicity to cytotoxicity is
relatively high.  Compounds are known that would graph somewhere in this
lower range, e.g., a few derivatives of ICR frameshift mutagensl^ a
metabolite of a polycyclic hydrocarbon^, and an inhibitor of DNA
synthesis^ are highly toxic, but apparently are nonmutagenic in mammalian
j.n vitro test systems.  Also, certain chemicals yield multiphasic cell
survival curves that cast doubt on the 037 concept for these mutagens.
The shaded area in Fig. 1 reflects values below the detection limit for the
systems studied.  The cytotoxicity data for non-mutagens would also fall
within this range.  Thus, the dynamic range for forward mutations in
mammalian ir\ vitro systems is approximately four orders of magnitude  (from
the lowest detectable level to the highest possible mutagenic potency at the
037 level of cytotoxicity).  Compounds near the bottom of this range will
presumably be of greater concern as cytotoxins than as mutagens.

    The relative mutagenicity of different compounds at a given cytotoxicity
(Fig. 1) is not significantly related to the class of mutagen or the forward
mutation marker scored.  This is shown in Fig. 2, which, displays the
observed values of the mutation frequency per locus at the 037 dose for
different classes of mutagens at different genetic loci.  This variation is
also not due to systematic differences among cell systems (data not shown).
                      \
    Cytotoxicity, as defined  (Fig. 1), may result from genetic  (i.e.,
DNA-related) and nongenetic mechanisms of injury.  Agents that induce the
highest mutation frequencies at the D37 dose may have the tightest
coupling between genetic injury and lethality, i.e., the cytotoxicity
related to DNA damage predominates over other forms of general toxicity.
Agents inducing lower mutation frequencies at the 037 dose may produce a
larger proportion of non-genetic injury.

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104


103
                0)
                I 1°1
                3

                I 10"
                3
                TJ

                  10-1
~i—rrn—i—rrn—i—rrn—i—rrn—r
                                                         i ' iii — nr
                                                            DMBA-


                         ./MOOT      BPox'
                         nMOA '  E
                      X  DMBAox«»
                                                DBAOX

                           102    103    104    105   106    107    108
                                            1
                                         D3?(M)
Fig. 1.  The relationship between induced mutation frequency per viable cell
         (M.F). per unit exposure dose (M, mole liter~l) and the
         reciprocal of D37 (M), i.e., the dose required to kill 63% of the
         initial cell population.  Killing is defined as the inability of a
         cell to undergo continued cell division in vitro resulting in a
         viable cell colony.  The D37 values were estimated from (1)
         authors' precise survival responses; (2) computer fits in ref. 14;
         (3) published tabular data  (occasionally over limited dose
         ranges).  In some cases, the values are approximated but individual
         estimates generally vary no more than +_ 20% and never more than ^
         50%  (in two cases).  Mutation frequency data usually included at
         least two dose points in the most linear range/ except for a few
         reports having only limited data where a single dose and zero dose,
         i.e., spontaneous frequency, were used.  Data included in this plot
         are those for mutations at  the hgprt locus  (hypoxanthine-guanine
         phosphoribosyltransferase, EC 2.4.2.7), aprt locus (adenine
         phosphoribosyltransferase, EC 2.4.2.8), and the ^jc locus  (thymidine
         kinase, EC 2.7.1.75).  Results in Chinese hamster ovary cells6-13
         (n = 25), V79 hamster cells!4-26 (n _ 18)f L5178Y mouse lymphoma
         cells27"30 (n = 4), normal human diploid fibroblasts31"37  (n =
         9), and human lymphoblasts38-39  (n - 4) were combined and
         expressed as the induced frequency of mutants resistant to
         azaguanine, AGr  (n = 27); thioguanine, TGr  (n = 27);
         azaadenine, AAr  (n = 4); and bromodeoxyuridine, BUdR^  (n = 2).

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         Abbreviations for the mutagens are given in Table 1.  The linear
         regression line is given by the equation (log M.F./M) = 1.03  (- log
         D37)  - 3.49, with a correlation coefficient of 0.93.  The dotted
         lines represent boundaries of the 95% confidence band for Y data
         points estimated from X.  The physical mutagens were entered on the
         figure after calculating their potencies relative to EMS, based on
         the ratios of the number of lesions induced in the DNA of a cell at
         the 037 doses (UV-induced dinners40 and total ionization
         lesions5)  to the number of alkylations41 induced by EMS at its
         037.   The "molar equivalent 037" values were obtained by
         multiplying the D37 for EMS (6 x 10~3 M) by the potency ratios
         for UV (0.18) and ionizing radiation  (1.4 x 10~3) .  The "molar
         equivalent mutation frequencies" were obtained by multiplying the
         geometric means of the observed mutation frequencies per 037 for
         UV and ionizing radiation by the respective "molar equivalent
         037" values.  The calculated parameters were added to the graph,
         but were not included in the regression calculation.  The lower
         detection limit of the assays  (stippled area) was estimated,
         assuming that (a) at frequencies below 10~5 induced mutations per
         viable cell, statistically-significant determinations of M.F. are
         generally not practical, and  (b) the maximum feasible exposure dose
         is usually  10 fold higher than the 037 concentration.


    The remarkable similarity among mutation frequencies at equitoxic
concentrations has been noted by others for several mutagens5,16,36.  The
correlation between cytotoxicity and mutagenicity need not be due solely to
the same type of cellular damage causing both lethal and mutational
events4; factors that influence the effective exposure of the cells to
chemical mutagens  (toxification, detoxification), may affect both end points
proper tionally.

    Additional data are needed to establish that partitioning of genetic and
nongenetic toxicity induced by a mutagenic agent can be estimated from the
magnitude of mutation induced at the 037 dose.  However, the data in Fig.
1 indicate that cytotoxicity as measured by the 037 dosage provides a
quantitative estimate of potential mutagenicity.  Where appropriate, more
specific bioassays can then be applied  to determine precisely the in vitro
mutagenic potency.

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Alkylating
agents
PAH
NQO, UV
X/y
Alkylating
agents
Frameshift
NQO, UV
X,7
Alkylating
agents
PAH
NQO, UV
M 'M
1

M
^^^
1 1 1

i L i 1
1 1

§8£$i-:'':-:-:"x-: ";::-:-:-:-:-:-
1 1 1

l( |l 1
1 1 1

^^^f^^^
1 1 1
AGr,
AAr
TGr,
BUdRr
OUAR
                    10
                       6
                        Mutation frequency per locus at the D37 dose

Fig. 2.  The induced mutation frequency per viable  cell  (M.F.)  calculated
         for the D37 exposure dose of the physical  and chemical mutagens

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listed in Table 1.  The loci include hgprt  (AGr>TGr),aprt,
(AAr ), and _tk (BUdRr), as well as resistance to ouabain
(OUAR)involving presumed lesions in the Na+-K+-ATPase enzyme  (EC
3.6.1.3).  The inner mark within bars represents the geometric mean
of data for all systems, with the range of  reported  values
indicated by the ends of each bar.  The arrows refer to the
authors' data for the Chinese hamster ovary multiple marker
system^.  According to the assumptions listed in Fig. 1,  the
lower limit for determining the M.F. at the D^-j would be  10"^.

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1.  Thacker, J., Stretch,  A.  & Stephens,  M.A.   Mutat.  Res.  42,  313-326
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2.  Chadwick, K.H.,  Leenhouts, H.P.,  Szumiel,  I.  & Nias,  A.H.W.   Int.  J.
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                                              NOTICE

                      This report was prepared as an account of work sponsored by the United
                      States Government. Neither the  United  States nor the United  States
                      Department of Energy, nor any  of their employees, nor any of their
                      contractors, subcontractors, or their employees, makes  any  warranty,
                      express or  implied, or assumes any legal liability or responsibility for the
                      accuracy, completeness or usefulness of any   information, apparatus,
                      product or process disclosed, or represents that its use would not infringe
                      privately-owned rights.

                      Reference  to a company or product name does not imply approval or
                      recommendation of the product by the University of California or the U.S.
                      Department of Energy to the exclusion of others that may be suitable.
                                                11

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                                   TECHNICAL REPORT DATA
                            (Please read Instructions on the reverse before completing]
1. REPORT NO.
 EPA-600/7-79-172
4. TITLE AND SUBTITLE
 Estimating the Potency of Mutagens:  Cytotoxicity as an
 Obligatory Consequency of Mutagenicity
             6. PERFORMING ORGANIZATION CODE
                                                           3. RECIPIENT'S ACCESSION NO.
             5. REPORT DATE
                August, 1979
7. AUTHOR(S)
 June II. Carver, Elbert  W.  Branscomb, Frederick T.  Match
             8. PERFORMING ORGANIZATION REPORT NO
                Dept. of  Energy
                UCRL-81690,  Rev.  2
9. PERFORMING ORGANIZATION NAME AND ADDRESS
 Lawrence Livermore  Laboratory
 Biomedical Sciences  Division
 University of California
 Livermore. CA  94550	
             10. PROGRAM ELEMENT NO.
                1NE 625F
             11. CONTRACT/GRANT NO.
                EPA-IAG-D5-E681-AN and AO
12. SPONSORING AGENCY NAME AND ADDRESS
U.  S.  Environmental Protection Agency
Washington,  CS  20460
             13. TYPE OF REPORT AND PERIOD COVERED
                Interim 1/78 thru  1/79
             14. SPONSORING AGENCY CODE
                                                              EPA/600/17
15. SUPPLEMENTARY NOTES
        This project  is  part of the EPA-planned and  coordinated Federal Interagency
        Energy/Environment  R & D Program.
16. ABSTRACT                                                                           ~~
            Rapid and reliable screening  methods are required  for  identifying
 environmental  mntap.ons anrl estimating  tlieir mutagenic potency  in  preparation for use
 of more  elaborate tests to assess  the  genetic risk to man.   On theoretical grounds,
 one expects  a  certain minimum cytotoxic  potency to correlate with  mutagenic potency,
 particularly when the latter is measured  using forward mutations  that  result in
 inactive  gene  products.  Furthermore, as  cells cannot divide unless  a  substantial
 fraction  of  their genome is functionally  intact,  mutagenic agents  should  also be
 obligatory cytotoxic agents, with  a given mutagenicity conferring  a  certain
 irreducible  cytotoxicity.   We show here  that the  cytotoxic potency of  22  chemical
 niutagens  is  highly correlated with their  mutagenic potency as assayed  in  five rodent
 and human  in vitro cell systems.   This  relationship implies  that  the maximum potential
 mutagenic  potency of such  compounds may be reliably estimated from rapid  and
 straightforward  measurements of their cytotoxic potency, the latter  defined as  the
 failure of cultured cells  to undergo continued cell division.  The estimate is
 necessarily  a  maximum one,  as an agent may exon  cytotoxic effects by  pathways
 indpendt;nt of  its mutagenic action.
17.
                                KEY WORDS AND DOCUMENT ANALYSIS
                  DESCRIPTORS
b.IDENTIFIERS/OPEN ENDED TERMS  C. COSATI Field/Group
        environmental tnutagens
        cytotoxic agents
        cytotoxic potency
        mutagenic potency
18. DISTRIBUTION STATEMENT
        Release to Public
19. SECURITY CLASS (This Report)
   Unclassified
21. NO. OF PAGES
  11
                                              20. SECURITY CLASS (This page)
                                                 Unclassified
                                                                         22. PRICE
EPA Form 2220-1 (9-73)

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