_     TECHNICAL REPORT DATA
                            (rlette rtfd Jnttrvcnoru on the severer be/ore completion
|1. REPORT NO.
   EPA/600/8-89/090
2.
|4. TITLE AND SUiTITLE

  Updated Health Effects Assessment  for  Chloroform
                             3. RECIPIENT'S ACCESSION NO
                                PB90-142423/AS
                             V REPORT DATE
                                                           *. PERFORMING ORGANIZATION CODE
7. AUTMOR(S)
                                                            . PERFORMING ORGANIZATION REPORT NO
«. PERFORMING ORGANIZATION NAME AND ADDRESS
                                                            10. PROGRAM ELEMENT NO.
                                                            11. CONTRACT/GRANT NO.
 12. SPONSORING AGENCY NAME AND ADDRESS
 Environmental  Criteria and Assessment  Office
 Office  of  Research and Development
 U.S. Environmental Protection Agency
 Cincinnati.  OH  45268	
                              13. TYPE OF REPORT AND PERIOD COVERED
                              14. SPONSORING AGENCY CODE

                                EPA/600/22
 IS SUPPLEMENTARY NOTES
 16. ABSTRACT
   This  report summarizes and evaluates information relevant  to  a  preliminary interim
 assessment of adverse health effects  associated with specific chemicals or compounds.
 The  Office of Emergency and Remedial  Response (Superfund) uses  these documents in
 preparing cost-benefit analyses  under Executive Order 12991  for decision-making under
 CERCLA.   All  estimates of acceptable  intakes and carcinogenic potency presented in
 this document should be considered  as preliminary and reflect limited resources
 allocated to this project.  The  intent in these assessments  is  to suggest acceptable
 exposure levels whenever sufficient data are available.  The interim values presented
 reflect the relative degree of hazard associated with exposure  or risk to the
 chemical(s) addressed.  Whenever possible, two categories of values  have been
 estimated for systemic toxicants (toxicants for which cancer is not  the endpoint of
 concern).  The first, RfDs or subchronic reference dose, is  an  estimate of an exposure
 level  that would not be expected to cause adverse effects when  exposure occurs during
 a limited time interval.  The RfO is  an estimate of an exposure level that would not
 be expected to cause adverse effects  when exposure occurs for a significant portion
 of the  lifespan.  For compounds  for which there is sufficient evidence of
 carcinogenicity, qi*s have been  computed, if appropriate, based on oral and
 inhalation data if available.
 i.
                                KEY WORDS AND DOCUMENT ANALYSIS
                  DESCRIPTORS
                                              b,IDENTIFIERS/OPEN ENDED TERMS
                                             COSATi Field/Croup
1*. DISTRIBUTION STATEMENT

  Public
                 10. SECURITY CLASS (Tha Rtporl/

                   Unrlassified
                                                                         21. NO. OF PACES
                                              20. SECURITY CLASS (Thil ptgtl
                                                Unclassified
                                                                         22. PRICE
EPA F«m 2220.1 (*•». 4.77)
                              BDITION i» OMOLCTC

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                                             EPA/600/8-89/090
                                             April,  1988
          HEALTH EFFECTS ASSESSMENT
                FOR CHLOROFORM
ENVIRONMENTAL CRITERIA AND ASSESSMENT OFFICE
OFFICE OF HEALTH AND ENVIRONMENTAL ASSESSMENT
      OFFICE OF  RESEARCH AND DEVELOPMENT
    U.S. ENVIRONMENTAL PROTECTION AGENCY
            CINCINNATI, OH  45268

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                                  DISCLAIMER

    This  document  has  been  reviewed  1n  accordance  with  the  U.S.  Environ-
mental  Protection  Agency's   peer  and administrative   review  policies  and
approved  for  publication.   Mention  of  trade  names  or commercial  products
does not constitute endorsement or recommendation for use.
                                      11

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                                    PREFACE
    This report  summarizes  and evaluates Information relevant  to  a prelimi-
nary  Interim  assessment of  adverse health  effects  associated with  chloro-
form.  All estimates of acceptable  Intakes  and  carcinogenic  potency present-
ed 1n  this  document  should  be considered as  preliminary  and reflect  limited
resources  allocated  to  this  project.   Pertinent  toxlcologlc  and  environ-
mental data were located through on-Hne  literature  searches of the Chemical
Abstracts,  TOXLINE,  CANCERLINE  and the  CHEMFATE/DATALOG  data bases.   The
basic  literature  searched  supporting  this  document  Is  current  up  to  May,
1987.  Secondary  sources  of  Information  have also  been  relied upon  In  the
preparation  of  this  report  and   represent  large-scale  health  assessment
efforts that entail  extensive peer  and Agency review.  The  following Office
of Health  and  Environmental  Assessment (OHEA) sources  have  been  extensively
utilized:

    U.S.  EPA.    1980a.   Ambient  Water  Quality  Criteria  Document  for
    Chloroform.   Prepared  by the  Office  of  Health and  Environmental
    Assessment,   Environmental   Criteria    and    Assessment   Office,
    Cincinnati, OH  for the  Office  of  Water  Regulations  and Standards,
    Washington, DC.  EPA-440/4-80-033.   NTIS PB 81-117442.

    U.S. EPA.   1982.  Hazard  Profile  for  Chloroform.  Prepared by  the
    Office  of   Health  and   Environmental   Assessment,   Environmental
    Criteria and  Assessment  Office,  Cincinnati,  OH  for  the Office  of
    Solid Waste, Washington, DC.

    U.S. EPA.   1983.   Review of Toxlcologlc Data 1n  Support of Evalua-
    tion  for  Carcinogenic  Potential  of  Chloroform.   Prepared by  the
    Office  of  Health  and  Environmental  Assessment,  Carcinogen Assess-
    ment  Group, Washington,  DC  for  the  Office of   Solid  Waste  and
    Emergency Response.

    U.S.  EPA.   1985.   Health  Assessment   Document  for   Chloroform.
    Office  of   Health  and   Environmental   Assessment,   Environmental
    Criteria  Assessment  Office,   Research   Triangle  Park, NC.    EPA
    600/8-84/004F.  NTIS PB 86-105004.

    U.S.  EPA.    1987a.   Integrated  Risk  Information  System   (IRIS).
    Reference  dose  (RfD)  for oral   exposure  for  chloroform.   On-Llne:
    (Verification  date 12/02/85).   Office  of Health and  Environmental
    Assessment,   Environmental   Criteria    and    Assessment   Office,
    Cincinnati, OH.

    U.S. EPA.   1987b.   Integrated Risk  Information  System (IRIS).   Risk
    estimate  for  carclnogenldty   for   chloroform.    On  Line:   Input
    pending.    (Verification   Date   8/26/87).   Office   of   Health  and
    Environmental  Assessment,  Environmental  Criteria  and  Assessment
    Office, Cincinnati, OH.
                                   111

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    The Intent 1n  these assessments  Is  to suggest  acceptable exposure levels
for  noncardnogens  and   risk   cancer   potency  estimates   for  carcinogens
whenever sufficient  data  were available.   Values  were not  derived  nor  were
larger  uncertainty factors employed when  the  variable data were  limited  1n
scope,  which  tended to generate conservative  (I.e.,  protective)  estimates.
Nevertheless,  the  Interim  values  presented reflect  the relative degree  of
hazard or risk associated with exposure to the chemlcal(s) addressed.

    Whenever  possible,  two categories  of  values  have  been   estimated  for
systemic  toxicants  (toxicants   for  which  cancer  1s  not   the endpolnt  of
concern).  The  first,  RfDg  (formerly AIS)  or  subchronlc reference  dose,  Is
an estimate of an  exposure level that  would not be expected to cause adverse
effects when  exposure occurs  during a  limited  time Interval   (I.e.,  for  an
Interval that  does  not constitute  a significant  portion of  the  Hfespan).
This type  of  exposure  estimate  has  not  been  extensively used, or  rigorously
defined, as  previous risk assessment  efforts  have been primarily  directed
towards  exposures  from  toxicants  1n  ambient  air  or  water  where  lifetime
exposure   Is  assumed.    Animal   data   used  for  RFD$  estimates   generally
Include exposures  with  durations of  30-90  days.  Subchronlc  human  data  are
rarely  available.   Reported exposures are  usually  from chronic occupational
exposure  situations  or  from  reports  of  acute accidental   exposure.   These
values  are   developed    for   both   Inhalation  (RfD$i)  and   oral   (RfD$0)
exposures.

    The  RfD  (formerly  AIC)  1s  similar  1n  concept  and addresses  chronic
exposure.  It  1s an  estimate of  an  exposure level  that would not be expected
to cause  adverse  effects   when  exposure occurs  for a  significant  portion  of
the  Hfespan  [see  U.S.  EPA (1980b)  for a  discussion  of  this  concept].   The
RfD  Is  route-specific  and estimates  acceptable  exposure  for either  oral
(RfD0)  or  Inhalation   (RfDj)  with  the  Implicit  assumption   that  exposure
by other routes 1s Insignificant.

    Composite  scores  (CSs)  for noncardnogens  have  also  been  calculated
where  data  permitted.    These  values  are  used  for  Identifying  reportable
quantities  and  the  methodology  for their  development  1s explained  In  U.S.
EPA  (1984).

    For compounds  for  which there  1s sufficient evidence of carclnogenlclty
RfD$  and  RfD values are  not derived.   For a discussion of risk  assessment
methodology  for  carcinogens refer  to U.S.  EPA (1980b).  Since cancer  1s  a
process that  1s  not characterized  by a  threshold, any exposure contributes
an  Increment  of  risk.  For carcinogens,  q-|*s have been  computed,  1f appro-
priate, based on oral and  Inhalation data 1f available.
                                      1v

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                                   ABSTRACT
    In  order  to  place the  risk  assessment  evaluation  In proper  context,
refer  to  the preface  of  this  document.   The  preface  outlines  limitations
appl'icable  to  all  documents  of  this  series  as  well  as the  appropriate
Interpretation and use of the quantitative estimates.

    Chloroform  has  been   shown  to  be  carcinogenic  by  the  oral  route  In
rodents  In  several  Independent  Investigations.   Human data  are  suggestive
for  chlorinated drinking  water,  but  are  Inadequate  for  chloroform  alone.
Chloroform  Is  classified  as  an  EPA  Group  B2  carcinogen,   probable  human
carcinogen, based on  sufficient  evidence from  animal  studies  and  Inadequate
evidence from human studies.

    U.S.  EPA  (1985) has  estimated  a  unit risk  for Inhalation exposure  of
2.3xlO~5   (vg/m3)"1   based   upon   route   extrapolation   from   a  q-j*   of
8.1xlO"2   (mg/kg/day)"1.     This  assessment   Is   based   upon   data   for
Incidence of liver tumors In male and female mice (NCI, 1976).

    U.S. EPA  (1987b)   has estimated an oral  q-|*  of 6.1xlO~8   (mg/kg/day)'1
based  upon  kidney tumors  In male rats  exposed  In  the drinking water  In  a
study by Jorgenson et  al. (1985).

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                               ACKNOWLEDGEMENTS
    The  Initial   draft  of  this  report  was  prepared  by  Syracuse  Research
Corporation  under  Contract No.  68-03-3112 for  EPA's  Environmental  Criteria
and  Assessment  Office,  Cincinnati,  OH.   Dr.  Christopher  DeRosa and  Karen
Blackburn were the Technical  Project  Monitors  and  Helen Ball  was the Project
Officer.  The final documents  In  this series  were  prepared  for the Office of
Emergency and Remedial Response, Washington, DC.

    Scientists from  the  following U.S. EPA offices  provided  review  comments
for this document series:

         Environmental Criteria and Assessment Office, Cincinnati, OH
         Carcinogen Assessment Group
         Office of Air Quality Planning and Standards
         Office of Solid Waste
         Office of Toxic Substances
         Office of Drinking Water

Editorial review for the document series was provided by the following:

    Judith 01 sen and Erma Durden
    Environmental Criteria and Assessment Office
    Cincinnati, OH

Technical  support  services   for  the  document  series  was  provided by  the
following:

    Bette Zwayer, Jacky Bohanon and K1m Davidson
    Environmental Criteria and Assessment Office
    Cincinnati, OH
                                      v1

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TABLE OF CONTENTS

1.
2.


3.








ENVIRONMENTAL CHEMISTRY AND FATE 	
ABSORPTION FACTORS IN HUMANS AND EXPERIMENTAL ANIMALS . . .
2.1.
2.2.
ORAL 	
INHALATION 	
TOXICITY IN HUMANS AND EXPERIMENTAL ANIMALS 	
3.1.


3.2.


SUBCHRONIC 	
3.1.1. Oral 	
3.1.2. Inhalation 	
CHRONIC 	
3.2.1. Oral 	
3.2.2. Inhalation 	
Page
. . . 1
. . . 3
. . . 3
. . . 3
. . . 5
. . . 5
. . . 5
, . , 7
, , , 7
. . . 7
. . . 8



4.








5.
w * w *

3.4.
i ui\n i uuuna v.1 i i mil* u i nun i\L.ri\uuuu i i *u LI I u\»
3.3.1. Oral 	 ,
3.3.2. Inhalation 	
TOXICANT INTERACTIONS 	
CARCINOGENICITY 	 	 ,
4.1.


4.2.


4.3.
4.4.
HUMAN DATA 	 	
4.1.1. Oral 	 ,
4.1.2. Inhalation 	
BIOASSAYS 	
4.2.1. Oral 	 ,
4.2.2. Inhalation 	
OTHER RELEVANT DATA 	
WEIGHT OF EVIDENCE 	
REGULATORY STANDARDS AND CRITERIA 	
	 9
	 10
	 10
	 12
	 12
	 12
	 12
	 12
	 12
	 16
	 16
	 19
	 20
       V11

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                               TABLE  OF  CONTENTS

                                                                        Page

 6.  RISK ASSESSMENT	   22

     6.1.   SUBCHRONIC REFERENCE DOSE (RfDs) 	   22
     6.2.   REFERENCE DOSE (RfD)	   22
     6.3.   CARCINOGENIC POTENCY (q-|*)	   22

            6.3.1.   Oral	   22
            6.3.2.   Inhalation	   22

 7.  REFERENCES	   25

APPENDIX: Summary Table for Chloroform 	   36

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                               LIST OF TABLES
No.                                 Title                             Page
3-1   Subchronlc Tox1c1ty  of  Chloroform  	    6
4-1   Oral  Bloassays  of  Chloroform Cardnogenldty	   13
4-2   Kidney Tumors  In Hale Osborne-Mendel Rats Exposed to
      Chloroform In  Drinking  Water for 104 Weeks	   17
                                     1x

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                             LIST OF  ABBREVIATIONS
ADI                     Acceptable dally Intake
ATP                     Adenoslne trlphosphate
bw                      Body weight
CAS                     Chemical abstract service
CS                      Composite score
DENA                    Dlethyl nltrosamlne
DNA                     Deoxyrlbonuclelc add
GGTase                  Gamma glutamyl transpeptldase
Koc                     Soil sorptlon coefficient
Kow                     Octanol/water partition coefficient
LOAEL                   Lowest-observed-adverse-effect level
ppm                     Parts per million
RfD                     Reference dose
RfDj                    Inhalation reference dose
RfDo                    Oral reference dose
RfD$                    Subchronlc reference dose
RfD$i                   Subchronlc Inhalation reference dose
RfD$o                   Subchronlc oral reference dose
SGOT                    Serum glutamlc oxaloacetlc transamlnase
SGPT                    Serum glutamlc pyruvlc transamlnase
STEL                    Short-term exposure limit
TLV                     Threshold limit value
TWA                     Time-weighted average

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                     1.  ENVIRONMENTAL CHEMISTRY AND FATE

    The relevant  physical  and chemical properties and  environmental  fate of
chloroform (CAS No. 67-66-3) are as follows:
    Chemical class:

    Molecular weight:
    Vapor pressure:
    Water solubility:
    Kow:
    B1oconcentrat1on factor:
    {In blueglll, Lepomls macrochlrus)
    Half-lives In
      air:
      water:
      halogenated aliphatic hydrocarbon
      (purgeable halocarbon)
      119.38 (Callahan et al..  1979)
      150.5 mm Hg at 20°C
      {Callahan et al., 1979)
      8200 mg/l at 20°C
      {Callahan et al., 1979)
      93 {Callahan et al., 1979)
      0-40 (Hutzler et al., 1983)
      6 (Barrows et al.,  1978)
      70-79 days
      (Atkinson, 1985;  NLM,  1987)
      0.3-3 days 1n rivers
      3-30 days 1n lakes
      (Zoeteman et al., 1980)
    Volatilization  1s  the  primary  fate  process  for  chloroform  1n  water
because of  the relatively  high  vapor pressure  (NLM,  1987).  Adsorption  to
suspended solids and  sediments and bloaccumulatlon  In aquatic  organisms will
not be significant (NLM, 1987).
    The half-life of  chloroform  1n  soil  could not  be located  In  the  litera-
ture searched;  however,  evaporation  1s expected  to be  the  predominant loss
mechanism from  the  soil  surface.   The half-life  for soil  evaporation should
be  longer   than Its  evaporation  half-life  from  water.   This  compound  1s
highly  mobile  In  most  soils, especially  those  with  high organic  carbon
content, (Hutzler  et al.,  1983)  and  In  subsurface soil  It 1s expected  to
001 OH
-1-
01/15/88

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remain   stable   enough  to   leach   Into  groundwater  (NLM,   1987).    Upon
contamination  of  groundwater,  chloroform  1s  likely  to  persist  for  long
periods  of  time  (no  degradation was  observed when  Incubated with  aquifer
material for 27 weeks) (Wilson et al., 1983).
    In  the  atmosphere,   reaction  with  photochemlcally  generated  hydroxyl
radicals will be  the  predominant  removal mechanism (NLM, 1987).   Based  on a
tropospherlc to  stratospheric turnover  time  of  30 years and  a  half-life  of
70-79  days,  <1% of the  tropospherlc  chloroform Is expected  to  diffuse  Into
the  stratosphere  (Callahan  et  al.,  1979;   Atkinson,  1985;  NLM,   1987).
Chloroform  1s  expected  to  be transported  long  distances from  Its  emission
sources based on the relatively slow rate of degradation 1n air.
0010H                               -2-                              01/20/88

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           2.   ABSORPTION  FACTORS  IN  HUMANS AND EXPERIMENTAL  ANIMALS
2.1.   ORAL
    Evidence  from  human assays  (Fry et al.,  1972),  as well as  from animal
experiments  (Brown  et  al.,  1974;  Taylor  et  al.,   1974),  Indicates  that
Ingested chloroform  1s  absorbed nearly  completely  from the  gastrointestinal
tract.   Brown  et  al.   (1974)  orally  administered  a  60  mg/kg  dose  of
14C-chloroform  to  mice, rats  and  squirrel monkeys  and recovered 93-98%  of
the administered dose of radioactivity  In  the  expired air,  urine and carcass
48  hours, after  treatment.   That  gastrointestinal  absorption  was  rapid  as
well  as  extensive  was  further  Indicated by the observation  that  peak blood
levels of radioactivity occurred at  1  hour 1n  the mice and monkeys.   In man,
peak  levels of 18C  In  the  blood  occurred  1 hour  after an oral  500 mg dose
of 13C-chloroform 1n olive oil by gelatin capsule (Fry et al., 1972).
    WHhey et  al.  (1982) administered  a  75 mg/kg  dose of chloroform  In  ~4
ml of  water  or corn oil to mature  fasted  rats to  Investigate  the effect  of
vehicle  on  gastrointestinal  absorption.   The  times  to  Initial peak  blood
concentrations  were   nearly  equivalent  at 5.6  minutes  for water  and  6.0
minutes  for corn  oil.  A second  peak 1n  blood concentration occurred  at  40
minutes  for  corn  oil-treated  rats.   The  postabsorptlon peak  blood concen-
tration  was  39.3 yg/m!.  when  administered  1n water  and   5.9  yg/mi  when
administered 1n corn oil,  and the area  under  the blood concentration curves
was 8.7  times  greater  for water  than for  corn oil,  which suggests  that the
large  volume  (for  a rat) of  corn oil  substantially  slowed  gastrointestinal
absorption.
2.2.   INHALATION
    Without providing documentation, U.S.  EPA (1980a)  stated that 49-77% of
the chloroform present  1n Inspired air  Is  absorbed  by the respiratory tract,
presumably In humans.
001 OH                                -3-                              01/15/88

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    U.S. EPA (1985) reviewed pulmonary  retention  data  from humans  during the
use  of  chloroform  as  an  anesthetic  (Lehmann and  Hasegawa,  1910;  Smith  et
al.,  1973).    Pulmonary   retention,  estimated  by  measuring  the  difference
between  Inhaled  and exhaled  concentrations of  chloroform and by  measuring
respiratory  rate,  was   observed  to  decrease  as   duration  of   exposure
Increased.   U.S.  EPA   (1985) estimated  retention at equilibrium at  -65-67%.
It  was   predicted  that  the percent  retained would  be  Independent of  the
Inspired  concentration and  therefore  that  estimations  based  on  very  high
concentrations  used   1n  anesthesia  (-8000-10,000  ppm)  would  be  equally
applicable   to   the   much   lower  levels  anticipated   with   environmental
exposure.  U.S. EPA (1985)  noted  that  chloroform retention would be expected
to be higher In  Individuals  with  larger than  average  proportions of body fat
because of the Upophlllc nature of the compound.
001 OH                               -4-                              01/15/88

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                3.   TOXICITY IN HUMANS AND EXPERIMENTAL ANIHALS
3.1.   SUBCHRONIC
    Table  3-1  presents  a  summary  of the  effects  of  subchronlc chloroform
exposure.
3.1.1.   Oral.   DeSalva et  al.  (1975)   reported  that  chloroform  at  dose
levels  of  1.0  and  2.5 mg/kg/day  for  1  year  produced  no  effects  on  the
functioning of the human liver and kidney.
    No effects  In  rats were  reported at dose levels  of  15  and 30 mg/kg/day
(Palmer  et  al.,  1979); however,  Increased  relative liver and  kidney weight
was observed at 150  mg/kg/day,  and  severe toxic  effects, such as necrosis of
the  liver  and  dysfunction  of  the  gonads  were produced  at  410  mg/kg/day
(Palmer et al., 1979).
    In an experiment  to  Investigate  the effect of  vehicle on  the hepato-
toxlclty  of  chloroform 1n mice,  Bull et al.  (1986)  administered chloroform
1n  corn  oil or  2X Emulphor  to  groups  of  9-10  male and  9-10  female B6C3F1
mice  at  0, 60,  130 or 270  mg/kg/day for  91-94 consecutive days.   In  male
mice, chloroform Increased  liver  weights when given 1n corn  oil but not  when
given In  Emulphor.   Chloroform  In either vehicle Increased the liver weights
of  female mice, but  the effect  was  greater  with  corn oil.   Elevated  SGOT
occurred  1n  a  dose-related manner  1n both sexes,  but  only  when the vehicle
was  corn  oil.   Upon   hlstopathologlc  examination,  fatty degeneration  was
observed  1n chloroform-treated  groups  with  the corn  oil  vehicle.   At  270
mg/kg/day,  the hepatic  architecture was  disrupted severely and early cirrho-
sis was evident.   These lesions  were  not observed In corn oil controls or In
mice  treated  with  chloroform  1n Emulphor.   Minimal  to mild  focal  necrosis
was the  only  lesion observed  1n mice treated with chloroform 1n Emulphor.
001 OH                               -5-                              01/20/88

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-6-
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The  Investigators  concluded   that   the   vehicle  strongly  Influences  the
hepatotoxldty of chloroform  1n mice and that  the  difference  1n vehicle may
explain  the  markedly  different  results  observed in  cancer studies  In mice
when nearly  equivalent total  doses  were  given 1n corn  oil  (NCI,  1976)  or
drinking water (Jorgenson et al., 1985) (Chapter 4).
3.1.2.    Inhalation.  Torkelson  et al.  (1976)  exposed rats, guinea  pigs and
rabbits  to  25,  50  or 85  ppm  (122,  244  or  415 mg/m3,  respectively),  7
hours/day, 5 days/week for  6 months  (see  Table 3-1).   Exposure to  25 ppm
chloroform produced  hlstopathologlcal changes  1n  the livers  and  kidneys  of
male but  not female  rats.   At  higher  doses,   lobular granular  degeneration
and  focal  necrosis  were  Increased   1n  the liver,  and  cloudy   swelling  of
epithelial cells was  Increased  1n the  kidney.   These changes were  reported
to  be   reversible  after  6  weeks.   Hematologlcal,   clinical  chemistry  and
urlnalysls values  were "within  normal limits."   The results obtained from
chloroform exposure  In guinea  pigs  and rabbits  are  difficult  to  Interpret
because adverse effects were seen  at  the  low-dose  (25 ppm)  and high-dose (85
ppm) levels,  but no  effects  were reported, at  the  Intermediate-dose  level
(50 ppm).
3.2.   CHRONIC
3.2.1.    Oral.   Several  chronic  oral studies  (NCI,   1976;  Palmer  et  al.,
1979; Roe et al., 1979) were  designed to  test  the cardnogenlclty of chloro-
form  (Chapter  4).   Depression of  body weight was  observed  at  chloroform
doses >60  mg/kg/day  1n rats  (NCI, 1976;  Palmer et al., 1979) and mice (Roe
et  al.,  1979).  Palmer  et al.  (1979) exposed  Sprague-Dawley rats  of both
sexes  to 60  mg/kg/day  of  chloroform  1n  a  toothpaste  base  for  80  weeks
followed by  15 weeks  of  observation.  Decreased  relative  liver weight and
plasma   chollnesterase  levels   were reported  In  female  rats (Palmer  et al.,
1979).    Rats  of  both  sexes  survived better  than the controls,  though both

001OH                               -7-                              01/15/88

-------
groups  had  a   high   Incidence   of   non-neoplast1c   respiratory  and  renal
disease.  There  were  no treatment-related effects on  the  Incidence  of  liver
or kidney tumors following  treatment  of  60  mg/kg/day  for 80 weeks.  Although
hlstologlcally - malignant  mammary tumors were  reported  more 1n treated than
1n  control  female  rats, the  difference was  not statistically significant
(Palmer et  al., 1979).   Higher  chloroform doses (90 and  180  mg/kg/day,  5
days/week for  78 weeks) resulted  1n  an Increased Incidence of noncancerous
respiratory diseases  1n  rats  (NCI, 1976), and  a gavage dose of 477 mg/kg/day
for 78 weeks resulted 1n decreased survival  1n female mice (NCI, 1976).
    Heywood et  al.  (1979)  administered  chloroform In a toothpaste  base  1n
gelatin capsules at  15  or   30 mg/kg/day,  6  days/week  for 7.5 years to groups
of eight  male  and  eight female beagle dogs.   A control  group of 16  dogs/sex
was maintained.  Fatty  cysts  developed  1n the  livers  of some dogs 1n each of
the  treated  groups,  and was  considered  to be  treatment-related.   SGPT  and
other   serum   enzyme  Indicators  of   liver   damage  were   elevated   1n   a
dose-related fashion.
    Chronic exposure  of humans  to chloroform  appears to result  1n adverse
effects on  the central  nervous  system  (NIOSH,  1974), although  there are  no
data  on  the dose relation  of the effects.  In addition,  chloroform affects
the  liver and  kidneys  1n   humans  (NIOSH,  1974).  The potential  for chronic
human  oral  exposure  to  chloroform has  Increased  because of  the widespread
practice  of chlorinating drinking water  (U.S. EPA, 1980a).
3.2.2.    Inhalation.   Epldemlologlcal  studies   of  humans exposed  to chloro-
form  In the workplace at levels  ranging  from  22-237  ppm have Indicated that
tiredness,  depression,  gastrointestinal   disturbances   (e.g.,  flatulence,
nausea),  headache  and  frequent  and  scalding  urination   are   the  primary
symptoms  (Challen  et al.,  1958;  Bomskl  et al. 1967).   Regarding long-term
effects,  Challen  et  al.   (1958)  reported  that  there  was  no  evidence  of

001 OH                               -8-                              01/20/88

-------
organic  lesions attributable  to  chloroform,  based  on  physical exams  and
liver  function  tests.   Bomskl  et  al.  (1967)  reported  that  chloroform
exposure at  levels  as  low as 2 ppm for  1-4  years  may result In an Increased
Incidence  of  toxic  hepatitis,  splenomegaly and  hepatomegaly,  although  no
statistical analysis and adequate controls were presented.
3.3.   TERATOGENICITY AND OTHER REPRODUCTIVE EFFECTS
3.3.1.   Oral.   Thompson et  al.  (1974)  performed   oral  range-finding  and
developmental  toxlclty  studies  where Sprague-Dawley rats  and Dutch-Belted
rabbits  were  used.   In  the  range-finding  study,  groups of   six rats  were
treated  by  gavage  with  79, 126,  300,  316 or 516 mg/kg/day  of  chloroform In
corn oil on  days 6-15  of gestation.  Maternal  toxlclty  was  observed at >126
mg/kg/day and  fetotoxlclty  was observed  at  >316 mg/kg/day.   In  the defini-
tive  study,  groups of  25 rats were  treated with  20,  50 or 126 mg/kg/day.
Maternal toxlclty  was   observed  at >50  mg/kg/day, but  no  adverse  develop-
mental  effects were reported  at  any  level.   The  range-finding  study  used
groups of  five rabbits and doses  of  25,  63, 100,  159,  251  or  398 mg/kg/day
on  days  6-18  of  gestation;  maternal toxlclty was  observed  at  all  dosage
levels.   In  the  two  dams  that  survived  at  100  mg/kg/day  one had  four
resorptlons and  the other was  not  pregnant.   The definitive  rabbit study was
performed  with  groups  of  15  rabbits   treated  with  at  20,  35  and  50
mg/kg/day.    Reduced  maternal  body  weight was  observed  at 35   but not  at  50
mg/kg/day and  reduced  fetal  body weight  was  observed at  35  but not  at 20 or
50 mg/kg/day.
    Ruddlck et  al.  (1983) administered  chloroform at 100, 200  or 400 mg/kg/
day to groups  of 15 mated Sprague-Dawley  rats  on  days  6-15  of  gestation.   A
dose-related  decrease   In maternal  body  weight  gain  was  observed at  all
dosage levels, while fetal body weight was decreased  only at 400 mg/kg/day.


001 OH                               -9-                              01/20/88

-------
This  group  also  had  a  higher  Incidence of  sternebral  anomalies and  fetal
runts.
    Palmer et al  (1979)  performed a study  1n  which  Sprague-Dawley  rats were
given dally  gavage  doses of 0,  15,  30,  150 and 410 mg/kg/day  of chloroform
In  toothpaste  (10  of  each  sex  per dose  level) for  13 weeks and  observed
gonadal atrophy In both sexes treated with 410 mg/kg/day.
    Burkhalter and  Balster  (1979) Investigated the effects  of  chloroform at
31.1  mg/kg/day  on behavior  1n developing  ICR mice.   Mice were  treated from
21 days before mating  until  21 days  after  birth.   The  offspring were treated
on days 7-2"!  of  age.   Treatment  had no  effect  on  Utter size,  but  offspring
body weights were reduced.   There was  no definite  effect of  treatment on the
behavior of the offspring.
3.3.2.   Inhalation.   Schwetz  et  al.  (1974)  exposed   groups  of  20  female
Sprague-Dawley  rats  to chloroform at  30,  100 or 300  ppm (146,  488  or  1465
mg/ma), 7  hours/day on  gestation days 6-15.  Maternal  toxldty, manifested
as decreased maternal  weight gain,  occurred  In all  exposed  groups.   Reduced
fetal crown-rump  length  was observed at 30  and  300  ppm but not  at  100 ppm.
Severe  teratogenlc  effects  were  observed at >100 ppm.   Fetal  resorptlon was
greatly Increased at  300 ppm.   Murray et al.  (1979) exposed groups  of mated
CF-1  mice  to chloroform at  100  ppm,  7 hours/day on days  6-15  of gestation.
Other  groups  of  mice  were exposed  to  100 ppm, 7  hours/day on  days  1-7 or
8-15  of gestation.  Effects  reported during one  or  more of the three periods
of  exposure  Include  Increased  resorpt1ons/!1tter,  decreased  fetal  body
weight  and  crown-rump  length,  delayed  skeletal ossification, Increased Inci-
dence  of  cleft palate  and maternal toxldty manifested as reduced  rate of
body weight gain and Increased liver weight.
0010H                               -10-                             01/15/88

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3.4.   TOXICANT INTERACTIONS
    The toxlclty of chloroform  1s greatly  Influenced  by  anything that alters
mlcrosomal  enzyme  activity  or  hepatic  GSH  levels  (U.S.  EPA,  1985).   The
substances  that  potentiate  the  toxic  effects  of  chloroform  are  methyl
n-butyl  ketone  (Branchflower   and  Pohl,  1981),   alcohol  (Kutob  and  Plaa,
1961),  carbon  tetrachlorlde  (Harris  et al.,  1982),  chlordecone  (I1j1ma  et
a!.,  1983),  DDT  and  phenobarbltal  (McLean,  1970).   Methyl n-butyl  ketone
Increases the  toxldty  of chloroform by  lowering glutathlone levels  and  by
Increasing the levels of  hepatic cytochrome  P-450 (which. In turn.  Increases
the  metabolism of  chloroform  to  phosgene)  and  by  decreasing  GSH  levels
(Branchflower  and  Pohl,  1981).  Harris  et al.  (1982)  reported that  carbon
tetrachlorlde  potentiated   the toxic   effects   of   chloroform  because   of
Increased phosgene  formation and  the Initiation  of I1p1d peroxldatlon.   The
mechanism of Interaction  for alcohol, chlordecone, DDT and phenobarbltal  was
not  discussed,   von   Oettlngen (1964)  reported  that  high-fat/low-protein
diets potentiated the hepatotoxlc  effects of chloroform 1n animals.
001 OH                               -11-                             01/20/88

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                              4.   CARCINOGENICITY
4.1.   HUMAN DATA
4.1.1.   Oral.   Although  chloroform  has  not  unequivocally  been  shown  to
cause human  cancer,  ecological  and  case control  studies  (Alavanja et  a!.,
1978; Cantor  et  al.,  1978;  Brennlman  et  al.,  1978;  Hogan  et  al.,  1979;
Struba,  1979;  Gottlieb  et al.,  1981;  Young et al.,  1981)  have consistently
supported  the association of  Increased  risk  of  bladder,  colon  and  rectal
cancer with oral  exposure to chlorinated drinking water (U.S. EPA,  1983)  In
which  trlhalomethanes  and   chloroform  are   the  contaminants   present  In
greatest  quantities.   A  detailed  description of  these  studies  and  their
strengths and weaknesses Is available 1n U.S.  EPA (1985).
4.1.2.   Inhalation.   Pertinent   data   regarding  an  association   between
chloroform  Inhalation and an Increased Incidence or  risk  of  cancer  were not
located 1n the available literature.
4.2.   BIOASSAYS
4.2.1.   Oral.   Table  4-1 summarizes the  available  data   from several  early
gavage  bloassays of  chloroform  cardnogenldty.   Eschenbrenner  and  Miller
(1945) reported  that a dose  level of  chloroform that  caused hepatic necrosis
when  given once  would  cause hepatic carcinoma  when  given repeatedly.   The
NCI  (1976) found  a  dose-related  Increase  1n hepatomas  1n both  sexes  when
mice  received chloroform  1n corn oil  by gavage, and  an  Increase  In  renal
epithelial  tumors 1n male  rats   receiving  chloroform In  corn oil  by  gavage
(see  Table 4-1).  The  Increased Incidence of  hepatic  and renal  tumors was
statistically  significant  (p<0.05).   Palmer et  al. (1979)  criticized the NCI
(1976)  study  because  rats  being treated  with  other  volatile carcinogenic
substances were housed In the same room as the chloroform-treated  rats.
0010H                               -12-                             04/12/88

-------
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001 OH
                                                             -13-
                                                                                                      01/15/88

-------
    Because chloroform has been a  contaminant  1n  toothpaste,  rats  (Palmer  et
al.,  1979),  mice  (Roe  et al.,  1979)  and  dogs  (Heywood  et  al,  1979)  were
treated  with  chloroform  1n  a  toothpaste  base Including  essential oils  as
flavor components.   Range-finding  studies were performed  1n all  experiments.
No  effects  at  dose  levels  of  15, 75  and  165 mg/kg/day  for 52  weeks  were
reported  In  rats.  When  female rats were  treated  with 60 mg/kg/day  for  96
weeks, however,  there  was an  Increase  (p=0.056)  1n malignant mammary gland
tumors   1n  the  chloroform-treated   group,   although   the  untreated   group
developed  benign  mammary  tumors   (Palmer   et al.,  1979).   There  was  an
Increased Incidence  of  kidney  tumors  In  the  high-dose (60 mg/kg/day) level
1n male  mice  (Roe et al., 1979).  The  females had  no  Increased  Incidence  of
cancer,  but  there appeared  to  be  some confounding  Influence because  of the
vehicle.  The authors addressed,  but  did  not resolve,  the  problem  of the
effect produced by different vehicles (Roe et al., 1979).
    Recent studies Indicate  that chloroform  1s carcinogenic  to rats and mice
when  administered  1n  drinking water.   Tumasonls  et  al.   (1985)  provided
groups of  32  male and 45 female Wlstar rats  with  drinking water  containing
chloroform  for  lifetime.   The  Initial  concentration,  2.9  g/l  (2900 ppm),
was reduced by  one-half  after 72 weeks to  maintain a  fairly  constant  Intake
of  chloroform  because  water  consumption   had  Increased.   The  dosage  of
chloroform  1s  estimated  at  ~200 mg/kg/day  for both sexes, based  on graphic
data  provided by  the  Investigators.   Controls consisted  of  28 male  and  22
female  rats  provided  with  tap water.  Treated  rats  weighed  substantially
less  than their  sex-matched controls  throughout the  experiment.   Survival
appeared  not  to be  affected by treatment.   The  most  noteworthy observation
was a  significantly  Increased  Incidence of  neoplastlc  nodules  1n  the liver
of female rats, 10/40 compared with 0/18 In controls (p<0.03).
001 OH                               -15-                             04/12/88

-------
    Jorgenson et al.  (1985)  provided  drinking  water  containing chloroform at
0,  200,  400,  900 or  1800  mg/fc (ppm)  to  groups of male  Osborne-Mendel  rats
and female  B6C3F1 mice  for 104 weeks.  Because water  consumption  Is  reduced
with high concentrations of  chloroform, a matched  control  group was  provided
water 1n amount to match the consumption  of  the high-dose groups.   For rats,
group sizes  were  330 for  controls and 200  ppm,  150  at  400  ppm and  50  for
matched controls, 900 and  1800 ppm.  Group sizes  for  mice were Identical  to
rats,  except  that   the  control  and  200  ppm groups  contained  430  mice.
Survival  of mice  appeared  to be  unaffected  by  treatment.   Treated  rats
survived longer than controls, attributed by  the  Investigators to the  fact
that  treated  animals were   leaner   because  of  decreased  water   and  food
Intake.   Several tumor  types occurred 1n rats  at  a significantly  Increased
Incidence, but only  kidney tumors,  which  occurred  1n  a dose-related  manner,
were  attributed  to   treatment  with  chloroform.   The Incidence  of  kidney
tumors  In  the  rats  1s  presented  1n  Table  4-2.   No  tumor type occurred  In
female mice  at  a  significantly greater Incidence  In  treated  groups  than  1n
controls.
4.2.2.   Inhalation.    Pertinent  data  regarding   the  cardnogenlcHy   of
Inhaled chloroform were  not located 1n the available  literature.
4.3.   OTHER RELEVANT DATA
    Chloroform was not  mutagenlc  In  Escher1ch1a coll  strains K12, WP2p  and
WP2uvrA"p or  1n  Salmonella  typhlmuMum strains  TA98,  TA100,  TA1535,  TA1537
and TA1538 (Klrkland et al.,  1981)  with or without S-9 metabolic activation.
Chloroform was not mutagenlc  In cultured  Chinese hamster  lung flbroblasts  at
the 8-azaguanlne locus  (Sturrock,  1977),  nor did  chloroform  Increase sister
chromatld exchanges  1n cultured Chinese hamster ovary  cells or human  lympho-
cytes (White et al.,  1979; Uehleke  et al.,  1977).  In  a recent experiment 1n


001 OH                               -16-                              04/12/88

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which  chloroform was  used  at a  higher  concentration,  chloroform  Induced
sister  chromatld exchange   1n  cultivated  human  lymphocytes  (Morlmoto  and
Koizumi, 1983).   Chloroform  was reported  to  be weakly positive  or  "sugges-
tive" In mutagenlclty assays 1n Saccharomyces cerevlslae D7  1n  the  presence
of  S-9  metabolic  activation,  and In  the  Induction  of muMne sperm  head
abnormalities (Agustln and L1m-Syl1anco,  1978;  Callen et al., 1980;  Land  et
al., 1981;  Topham, 1980;  Gocke et al., 1981).
    Several  authors  have Investigated  the mechanism  for  chloroform-Induced
carc1nogen1c1ty  In  laboratory  animals.    Reltz  et al.  (1982)  measured  DNA
alkylatlon and  repair  and cellular  regeneration  In  male  B6C3F1 mice  given
single  15,  60   or  240  mg/kg  oral  doses  of  chloroform.   DNA  alkylatlon,
estimated  as  ymol of  bound   chloroform/mo 1  of  DNA,  was  1.5, compared  with
6000-7430  ymol/mol  for  dlmethylnltrosamlne,  a  known genotoxlc  carcinogen.
Using   a   technique   Involving   Incorporation   of  3H-thym1d1ne  Into   DNA
following  treatment   with  hydroxyurea  sufficient  to  depress   normal   DNA
synthesis,  these  Investigators  determined  that  chloroform did not Induce DNA
repair  1n  the  livers  of  treated  mice.   Cellular  regeneration,   estimated  by
8H-thym1d1ne  Incorporation   Into   DNA  In  nonhydroxyurea-treated  mice,   was
Increased   14-fold   In   the   liver   and  25-fold   In   the   kidneys   of
chloroform-treated  mice.    The   authors   concluded   that   cardnogenlclty
associated with  chloroform was due to  cellular necrosis  rather  than to DNA
damage.
    In  Initiation-promotion   experiments  with  male  Sprague-Dawley  rats,
Perelra  et  al.   (1982)  determined  that  chloroform   did  not  Initiate  the
development  of   GGTase-pos1t1ve  fod  1n  the livers  of rats  promoted  with
phenobarbltal,   and  the  results concerning  the  promoting  activity   1n  rats
pretreated  with  d1ethyln1trosam1ne  (DENA),  was   not  conclusive.  Demi  and

OQ10H                               -18-                             04/12/88

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Oesterle  (1985),  however,  reported that chloroform promoted  the  development
of DENA-lnduced ATPase deficient fod and  GGTase-pos1t1ve  foci  In  the  livers
of female Sprague-Dawley rats.
    Klaunlg et al.  (1986) provided  chloroform  1n  drinking  water  for  52 weeks
to male  B6C3F1 mice  that were  treated with  DENA In  drinking  water   for  4
weeks  to  Initiate  tumor  formation.   Neither   DENA  nor  chloroform  alone
Increased  the  Incidence  of tumors, but  chloroform Inhibited Hver  and lung
tumor 1 genes Is 1n the DENA-1n1t1ated mice.
4.4.    WEIGHT OF EVIDENCE
    Oral  exposure  to chloroform has  caused hepatic  carcinomas  1n male  and
female  B6C3F1   mice  (NCI,  1976),  renal   carcinomas  and  adenomas  1n  male
Osborne-Mendel rats (NCI, 1976; Jorgenson  et al.,  1985)  and  In  male  ICI mice
(Roe et al., 1979), thyroid tumors  1n  female Osborne-Mendel  rats  (NCI, 1976)
and an  slightly  Increased  Incidence of malignant mammary  gland  tumors after
chronic exposure  1n Sprague-Dawley rats (Palmer et al., 1979).   Evidence  1s
sufficient  to  classify  chloroform as  an  animal  carcinogen.  Although  some
association  between oral  exposure  to  chlorinated  drinking  water (1n  which
tMhalomethanes  and  chloroform  usually   predominates)  and  human  bladder,
Intestinal  and rectal cancer has  been reported  (see  Section  4.1.1.),  the
evidence  for  human  carclnogenldty   of   chloroform  Itself  1s  Inadequate.
Applying  the  criteria   for  evaluating the overall  weight   of  evidence  of
carclnogenldty to  humans  adopted  by  the  Carcinogen Assessment Group  of  the
U.S.   EPA  (1986),  chloroform  1s  classified In  Group  B2,  a probable  human
carcinogen.  This classification 1s consistent with the  analysis  by  U.S.  EPA
(1985).
001 OH                               -19-                             04/12/88

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                     5.   REGULATORY STANDARDS AND  CRITERIA

    The  ACGIH  (1986a,b)   recommends  a  tWA-TLV  of  10  ppm  {50  mg/m3)  for
occupational  exposure  to  chloroform  and  also  notes  that  chloroform  has
Induced  cancer  1n animals by  the oral  route at  high and  Intermediate  dose
levels  and  1s  a  suspected  carcinogen  for  humans.   OSHA  (1985)  has set  a
celling  limit  for  chloroform  of  50  ppm  (240  mg/m3}  1n  the  workroom
atmosphere.
    U.S.  EPA  (1987a)  reports  an RfD  for  oral  exposure  to chloroform  of
IxlO"2  mg/kg/day  or  1  mg/day  for a  70 kg  human,  based on  the  development
of fatty cysts  1n the livers of  dogs treated with  15  mg/kg/day,  6 days/week
for 7.5 years (Heywood et al.,  1979).
    The  Carcinogen Assessment  Group (U.S.  EPA, 1985)  analyzed  the following
data:   liver  tumors  1n  female  mice (NCI, 1976);  liver  tumors 1n male  mice
(NCI, 1976); kidney  tumors 1n male rats  (NCI, 1976;  Gorgenson et  al., 1985);
and kidney tumors  1n male  mice  (Roe  et  al.,  1979).   The  largest estimates  of
carcinogenic  potency were derived  from  the liver  tumor  data  In male and
female   mice   1n   the   NCI   (1976)  gavage   study.    A   q^  of   8.1xlO~2
(mg/kg/day)"1  was  derived  as  the  geometric   mean  of  the  q  *s   derived
separately for  male  and female mice.  A complete discussion  of  this  deriva-
tion  1s  presented In U.S. EPA  (1985).   More recently,  the CRAVE  work group
(U.S. EPA,  1987b) recommended  that  the q^  for  oral exposure via  drinking
water be based upon  the drinking water  study by  Jorgenson  et al.  (1985).
The  Jorgenson  study  was  Included  1n  the  Health   Assessment  Document  for
Chloroform  (U.S.  EPAS,  1985) but  was  not  selected as the  primary  basis  for
drinking water  risk  estimation.   Given  the  CRAVE action (U.S. EPA,  1987b),
the  Agency  now  uses   the  q-j*  value  of  6.1xlO~3   (mg/kg/day)'1  based  on


0010H                               -20-                             04/12/88

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the Incidence of kidney tumors  In  male  rats  In the study by Jorgenson et al.
(1985).  The  upper  bound  estimate of cancer  risk  for exposure to 1  yg/L  of
chloroform In water Is 1.7xlO"7.
    Using   q-j*   of    S.lxlO"2   (mg/kg/dayT1,    EPA   (1985)    calculated
upper-bound  estimates of  cancer  risk  for exposure  to  1  yg/m3  In air  to
be  2.3xl(T5.    This   q,*   for   Inhalation   exposure  to  chloroform   was
validated by the CRAVE work group on August 26, 1987 (EPA, 1987).
001 OH                               -21-                             04/12/88

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                              6.   RISK ASSESSMENT
6.1.   SUBCHRONIC REFERENCE DOSE (RfD$)
    Chloroform  1s  known to  be carcinogenic  to  animals and  1s  suspected  of
being  carcinogenic   to  humans.   Data  are  sufficient  for  derivation  of  a
q,*; therefore, It 1s Inappropriate to derive an RfD_ for this chemical.
6.2.   REFERENCE DOSE (RfD)
    Chloroform  Is  known to  be carcinogenic  to  animals and  1s  suspected  of
being  carcinogenic   to  humans.   Data  are  sufficient  for  derivation  of  a
q,*; therefore, 1t Is Inappropriate to derive an RfD for this chemical.
6.3.   CARCINOGENIC POTENCY (q.,*)
6.3.1.   Oral.   The  CRAVE  work  group  (EPA,  1987)  validated  a  q^   of
6.1xlO~a  (mg/kg/day)"1  based  on  the  Incidence of  kidney  tumors  1n male
rats exposed  1n drinking water  1n  the study by Jorgenson et al.  (1985).  The
upper  bound  estimate of  cancer risk  for  exposure  to  1 yg/L of  chloroform
1n water Is 1.7xlO~7.
    In this revaluation,  1t  was concluded that oral exposure  In  the  drink-
Ing water  approximated  potential human exposure more appropriately  than  did
gavage exposure using an oil  vehicle.   For  this  reason, the Jorgenson  et  al.
(1985) study was selected  as  the basis  for  potency estimation as compared  to
a previous estimate which utilized data from NCI (1976)  as the basis.
6.3.2.   Inhalation.    Data   regarding   the  cardnogenlclty   of  Inhaled
chloroform  1n humans and  animals were not  available.   Studies  1n animals
Indicate  that chloroform  1s  carcinogenic  by  the oral  route.    NCI  (1976)
found  dose-related  Increased  Incidences of hepatocellular  carcinoma 1n male
and female  mice treated by  gavage at  time-weighted average (TWA)  doses  of
>138  mg/kg/day  5   days/week  for  78  weeks,   and  a  dose-related  Increased
Incidence  of  kidney  epithelial  tumors  1n male rats  similarly  treated  by


001 OH                               -22-                             04/12/88

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gavage  at  90  and  180 mg/kg/day.   Roe  et  al.  (1979)  found  an  Increased
Incidence  of  kidney  epithelial  tumors  In male  mice  given  60 mg/kg/day  6
days/week  for  78  weeks.   Dose-related Increased  Incidences of  renal  tubular
cell adenomas and/or carcinomas were  found  1n male  rats treated with chloro-
form In the drinking water  at  levels  equivalent  to  dosages >38 mg/kg/day for
104 weeks  (Jorgenson et al., 1985).
    The U.S. EPA  (1985a)  considered these five data  sets  1n  determining the
q,* for  chloroform.  The  five data sets were as follows:  1)  liver  tumors
1n  female  mice (NCI,  1976),  2)  liver  tumors 1n male  mice {NCI,  1976),  3)
kidney  tumors  In  male rats  (NCI,  1976),  4) kidney  tumors  1n male  mice (Roe
et  al.,  1979),  and 5) kidney  tumors  1n  male  rats  (Jorgenson et  al.,  1985).
U.S.  EPA  (1985a)  used  available  pharmacoklnetlc  data  to  calculate  an
effective  close  for these  studies,  assuming  that  the amount metabolized  to
reactive   metabolites   Is  the   gavage   dose  minus   the  amount   excreted
unchanged.  For mice  given 60 mg/kg, as  1n the Roe  et  al.  (1979)  study, the
correction was  6%.  For  rats  at  the  same dosage,  It  was 20%.  In  the NCI
(1976)  study 1n which  rats and mice  received doses  of  ~200-500 mg/kg/day,  a
20% correction  was considered  conservative and  would  probably overestimate
the  amount  metabolized   from   these  doses.   U.S.   EPA  (1985a)  used  these
correction  factors to  reduce  the  administered  dose  by  the  unmetabollzed
portion  (6%  1n  mice and 20% In rats when given as  a  bolus  by  gavage  1n corn
oil, 0% when administered  1n  drinking water).  Doses  were also corrected for
differences  between animal  and  human  pharmacoklnetlcs  by using  a  surface
area correction.   Using  these  corrected  doses, maximum likelihood  estimates
of  the  parameters  of  the multistage model were  calculated for each  of the
five data  sets.   U.S.  EPA  (1985a)  chose  the  mouse  liver  tumor  data from the
NCI (1976) study  as the basis  of  the  potency factor  for  Inhalation exposure


001 OH                               -23-                             04/12/88

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to chloroform.  The NCI  (1976)  study  Is  considered  to be appropriate for use
1n  the  Inhalation  risk estimate  because  there  were  no Inhalation  cancer
bloassays and  no pharmacoklnetlc  data  to  contralndlcate  the use of  gavage
data  (U.S.  EPA,  1987b).   The  geometric  mean of  the estimates for  male and
female  mice   In   the   NCI   (1976)   study,   8.1xlO~2   (mg/kg/day)'1,   was
recommended  as  the  Inhalation   q *  for  chloroform.    U.S.   EPA   (1985a)
combined  the  estimates for   both  data  sets  because  the  data  for  males
Included observations at a lower  dose, which appeared  to  be consistent with
the  female  data.   U.S.  EPA  (1985a)  noted  that  the  recommended  q,*  was
similar  to  the  geometric  mean calculated  from all  five estimates  and was
also  similar  to the  estimate  calculated  1f  data for  both  sexes of  B6C3F1
mice  1n   the  NCI   (1976)  study  were  pooled.    Using  q^   of  8.1xlO"2
(mg/kg/day)"1, U.S.  EPA (1985)  calculated upper-bound  estimates of  cancer
risk  for  exposure  to  1   vg/m3   1n   air   to  be  2.3xlO~5.    This  q^  for
Inhalation exposure  to  chloroform was validated  by  the CRAVE work  group  on
August 26, 1987 (U.S. EPA,  1987b).
001 OH                               -24-                             04/12/88

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                                7.  REFERENCES

ACGIH  (American  Conference  of  Governmental  Industrial  Hyg1en1sts).   1986a.
Threshold Limit  Values for  Chemical  Substances and  Physical  Agents  1n  the
Workroom Environment.  Cincinnati, OH.  p. 13.

ACGIH  (American  Conference  of  Governmental  Industrial  Hyglenlsts).   1986b.
Documentation of the  threshold  limit  values  and biological  exposure Indices,
5th ed.  Cincinnati, OH.  p. 130-131.

Agustln,  J.S.  and  C.Y.   L1m-Syl1anco.    1978.   Mutagenlc  and  clastogenlc
effects  of  chloroform.  Bull.  Philadelphia Blochem.  Soc.   1:  17-23.   (Cited
In U.S. EPA, 1982)

Alavanja, M.,  I.  Goldstein  and M. Susser.   1978.   A case control  study  of
gastrointestinal  and  urinary  tract  cancer   mortality  and  drinking  water
chlorlnatlon.   In:  Water   Chlor1nat1on:  Environmental  Impact  and  Health
Effects,  Vol.  2,  R.L.  Jolley,  H. Gorchey and D.H. Hamilton,  Jr.,  Ed.   Ann
Arbor  Science  Publishers, Ann  Arbor,  MI.   p. 394-409.  (Cited  In  U.S.  EPA,
1983)

Atkinson, R.   1985.  Kinetics  and mechanisms  of the  gas-phase  reactions  of
hydroxyl  radical with organic  compounds  under atmospheric  conditions.   Chem.
Rev.  85: 69-201.

Barrows,  M.f:.,  S.R. PetrocelH,  K.3.  Macek  and J.  Carroll.   1978.  Blocon-
centratlon  and elimination  of  selected water  pollutants  by blueglll sunflsh.
Am. Chem. Soc., D1v. Environ. Chem.  18: 345-346.

0010H                               -25-                             01/20/88

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Bomskl, H.,  A. Sobolweska  and A.  Strakowskl.   1967.  Toxic  damage of  the
liver  by   chloroform  In  chemical  Industry workers.   Arch.  Gewerbepathol.
Gewerbehy.  24: 127-134.   (Ger.)  (Cited 1n U.S.  EPA,  1982)

Branchflower, R.V. and L.R.  Pohl.   1981.   Investigation of  the mechanism  of
the potentlatlon  of  chloroform-Induced  hepatotoxldty and nephrotoxldty  by
methyl n-butyl ketone.   Toxlcol. Appl.  Pharmacol.   16(3):  407-413.

Brennlman, G.R.,  J.  Vas1lomanolak1s-Lagos,  J.  Amsel, T.  Namekata  and A.H.
Wolff.  1978.   Case-control  study of cancer  deaths In Illinois communities
served  by chlorinated  or  nonchloMnated  water.   J.TK  Water  Chlor1nat1on:
Environmental  Impact  and  Health  Effects,  R.J.  Jolley,  H.  Gorchen  and   H.
Hamilton,   Jr.,   Ed.    Ann   Arbor   Science  Publishers,   Ann  Arbor,  MI.
p. 1043-1057.  (Cited 1n U.S. EPA, 1983)

Brown, D.M.,  P.P.  Langley,  D.  Smith and  D.C.  Taylor.  1974.  Metabolism  of
chloroform.   I.  The  metabolism  of  14C-chloroform  by  different   species.
Xenoblotlca.   4: 151-163.   (Cited 1n U.S.  EPA, 1985)

Bull,  R.J.,  J.M.  Brown,  E.A. Melerhenry,  et  al.   1986.  Enhancement of the
hepatotoxldty  of  chloroform 1n  B6C3F1  mice by corn  oil:   Implications for
chloroform cardnogenesls.   Environ.  Health Perspect.   69: 49-58.

Burkhalter,  J. and R.L. Balster.  1979.   Behavioral teratology evaluation  of
chloroform 1n  mice.   Neurobehavloral Toxlcol.   1:  199-205.    (Cited  1n U.S.
EPA, 1985)
001 OH                               -26-                             01/20/88

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Callahan,  M.A..  M.H.   Shlmak,  N.W.  Gabel,  et  al.   1979.    Water-Related
Environmental Fate of 129 Priority Pollutants. Vol.  II.  U.S. EPA, Office of
Water Planning  and Standards,  Office  of Water  and  Waste  Management, Wash-
ington,  DC.  EPA 440/4-79-029b.

Callen,  D.F., C.R.  Wolf and R.M.  Phllpot.  1980.  Cytochrome P-450  mediated
genetic   activity  and   cytotoxlclty  of  seven halogenated  aliphatic  hydro-
carbons   1n  Saccharomyces  cerevlslae.   Mutat.  Res.   77:  55-63.   (CHed 1n
U.S. EPA, 1982)

Cantor,  K.P.,  R.  Hoover,  T.J. Mason and  L.3. McCabe.   1978.  Association of
cancer mortality with halomethanes In drinking water.   J.  Natl. Cancer Inst.
61(4): 979-985.  (CHed In U.S.  EPA,  1983)

Challen,  P.J.R.,  D.E.  H1ck1sh  and  J.   Bedford.   1958.  Chronic  chloroform
Intoxication,.  Br. 0. Ind. Med.   15:  243-249.   (CHed In U.S.  EPA,  1982)

Demi,  E.  and  D.  Oesterle.   1985.    Dose-dependent promoting  activity of
chloroform In rat  liver foci bloassay.   Cancer Lett.   29: 59-63.

DeSalva,  S.(,  A.   Volpe,  G.  Leigh  and  T.  Regan.   1975.   Long-term  safety
studies  of  a chloroform-containing dentifrice and mouth-rinse  1n  man.   Food
Cosmet.  Toxlcol.   13: 529.  (CHed In U.S. EPA,  1982)

Eschenbrenner, A.B. and E.  Miller.   1945.   Induction of hepatomas  In mice by
repeated  oral administration  of chloroform, with observations on  sex differ-
ences.  3. Natl. Cancer Inst.  5:  251-255.  (CHed 1n U.S.  EPA,  1982)
001 OH                               -27-                             01/20/88

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Fry,  J.,  T.  Taylor  and  D.F.  Hathaway.   1972.   Pulmonary  elimination  of
chloroform and Us metabolite 1n man.  Arch.  Int.  Pharmacodyn.   196:  98-111.
(Cited 1n U.S. EPA, 1985)

Gocke,  E.f  M.T.  King,  K. Eckhardt  and  D.  Wild.   1981.   Hutagen1c1ty  of
cosmetics  Ingredients  licensed  by  the  European  communities.   Mutat.  Res.
90: 91-109.   (Cited In U.S. EPA,  1982)

Gottlieb, M.S.,  O.K.  Carr and  D.T. Morrlss.   1981.   Cancer  and  drinking
water  1n  Louisiana:  Colon and  rectum.   Int. Epldemlol.   10(2):  117-125.
(Cited In U.S. EPA, 1983)

Harris, R.N.,  0.  Ratnayake, 0.  Harris,  V.F.  Garry  and M.H. Anders.   1982.
Interactive hepatotoxlclty of chloroform and  carbon  tetrachlorlde.   Toxlcol.
Appl. Pharmacol.   63(2):  281-291.

Heywood, R., R.J. Sortwell, P.R.B. Noel, et al.  1979.   Safety  evaluation  of
toothpaste containing  chloroform.   III.  Long-term  study In beagle dogs.   3.
Environ. Toxlcol.  2: 835-851.   (Cited In U.S. EPA, 1982)

Hogan,  M.D.,   P.  Ch1,  D.G.  Hoel   and   T.J.  Mitchell.   1979.    Association
between chloroform  levels  In  finished   drinking water  supplies and  various
site-specific  cancer  mortality  rates.   J.  Environ.   Pathol.  Toxlcol.   2:
873-887.  (Cited  1n U.S.  EPA,  1983)

Hutzler,  N.J.,  J.C.  Crlttenden,   J.L.  OravHz  and  P.A.  Schaepe.   1983.
Groundwater   transport  of  chlorinated  organic  compounds.   Am.  Chem.  Soc.
186th Natl.  Mtg.  D1v. Environ.  Chem. Preprints.  23:  499-502.

0010H                               -28-                              01/20/88

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I1j1ma, M., M.G.  Cote  and G.L. Plaa.  1983.  A  sem1quant1tat1ve  morphologic
assessment  of  chlordecone-potentlated  chloroform hepatotoxldty.   Toxlcol.
Lett.  17(3-4): 307-314.

Jorgenson,  T.A.,  E.F.   Melerhenry,  C.J.  Rushbrook,  et  al.  1985.   Carclno-
genldty  of chloroform  1n  drinking water  to male  Osborne-Mendel  rats  and
female B6C3F1  mice.  Fund. Appl.  Toxlcol.  5: 760-769.

Klrkland, D.J., K.L. Smith  and N.O. Van Abbe.   1981.   Failure  of chloroform
to  Induce  chromosome  damage or slster-chromatld  exchanges  In cultured  human
lymphocytes  and  failure to   Induce  reversion  In  Escherlchla  coll.   Food
Cosmet. Toxlcol.  19(5): 651-656.

Klaunlg,  J.!-.,  R.G.   Ruch   and   M.A.  Perelra.    1986.   Carclnogenlclty  of
chlorinated methane  and ethane compounds  administered  In drinking water  to
mice.  Environ. Health Perspect.   69: 89-95.

Kutob, S.D. and  G.L.  Plaa.   1961.  The  effect of acute ethanol  Intoxication
on  chloroform-Induced  liver  damage.  J.  Pharmacol. Exp.  Ther.   135:  245-251.
(Cited 1n U.S. EPA, 1982)

Land,  P.C., E.L.  Owen  and  H.W.  Llnde.   1981.   Morphologic changes  1n  mouse
spermatozoa after  exposure  to Inhalatlonal  anesthetics  during  early  sperma-
togenesls.  Anestheslology.   54 53-56.    (Cited 1n U.S.  EPA, 1982)

Lehmann, K.B.  and  0.  Hasegawa.  1910.    Studies  of the  absorption of  chlori-
nated  hydrocarbons 1n  animals  and  humans.   Arch. Hyg.   72:  327-342.   (Ger.)
(Cited 1n U.S. EPA, 1985)

0010H                               -29-                             01/20/88

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McLean,  A.E.M.   1970.   The  effects  of  protein  deficiency  and  mlcrosomal
enzyme Induction by  DDT  and phenobarbltone on the acute  toxldty  of  chloro-
form and  pyrro!1z1d1ne  alkaloid retrorslne.  Br.  J.  Exp. Pathol.   51:  317.
(Cited In U.S. EPA, 1980a)

Morlmoto, K. and A.  Koizumi.  1983.  Trlhalomethanes  Induce sister  chromatld
exchanges In human lymphocytes Jm vitro and mouse  bone marrow  cells U^ vivo.
Environ.  Res.  32(1): 72-79.

Hurray, F.J., B.A. Schwetz,  3.G.  McBrlde  and R.E. Staples.  1979.  Toxlclty
of Inhaled chloroform 1n pregnant  mice  and their offspring.  Toxlcol.  Appl.
Pharmacol.  50:  515-522.   (Cited 1n U.S. EPA,  1985}

NCI  (National Cancer Institute).   1976.   Report on  Cardnogenesls Bloassay
of Chloroform.  NTIS  PB-264-018.  (CHed In U.S.  EPA,  1982)

NIOSH  (National  Institute  for  Occupational   Safety and  Health).    1974.
Criteria   for  a  Recommended  Standard...Occupational  Exposure  to Chloroform.
U.S. DHEW, PHS,  CDC,  Rockvllle,  MD.   NTIS  PB-246-695.

NLM  (National Library of  Medicine).  1987.   Hazardous  Substance Data  Bank.
Record No. 56, Computer  Printout.

OSHA  (Occupational Safety  and  Health Administration).   1985.   OSHA  Occupa-
tional Standards and  Permissible Exposure  Limits.  29  CFR  1910.1000.
0010H                               -30-                             01/20/88

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Palmer, A.K., A.E. Street, F.J.C. Roe, A.N. Worden and N.3. Van Abbe.  1979.
Safety  evaluation  of   toothpaste  containing  chloroform.   II.  Long-term
studies 1n rats.  3.  Environ.  Pathol.  Toxlcol.   2:  821-833.

Perelra. M.A.,  L-H.C.  L1n, 3.M.  LIppHt  and S.L.  Herren.   1982.  Trlhalo-
methanes  as   Initiators  and  promoters  of  cardnogenesls.   Environ.  Health
Perspect.  46: 151-156.

Reltz,  R.H.,  T.R.  Fox  and 3.F.  Quast.  1982. Mechanistic considerations for
carcinogenic  risk  estimation:  Chloroform.  Environ.  Health  Perspect.   46:
163-168.

Roe,  F.3.C., A.K.  Palmer, A.N.  Worden and N.3.  Van Abbe.   1979.   Safety
evaluation  of  toothpaste  containing  chloroform.   I.  Long-term  studies  In
mice.   3. Environ. Toxlcol.  2:  799-819.

Ruddlck, J.A.,  D.C.  VUleneuve  and I.  Chu.   1983.  A teratologlcal assess-
ment  of four trlhalomethanes  In the rat.   3. Environ. Sd. Health.  618(3):
333-349.

Schwetz, B.A.,  B.K.3.  Leong and  P.3.  Gehrlng.   1974.   Embryo- and fetotoxlc-
1ty  of  Inhaled  chloroform 1n  rats.   Toxlcol. Appl. Pharmacol.  28: 442-451.
(Cited  In U,,S. EPA, 1985)

Smith,  A.A,,  P.O.  Volpetto,  Z.W.   Gremllng,  et  al.   1973.    Chloroform,
halothane  and  regional  anesthesia.  A  comparative study.   Anesth.  Analg.
52:  1-11.  (Cited  1n U.S. EPA, 1985)
001 OH                               -31-                            01/20/88

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Struba,  R.J.    1979.   Cancer  and drinking  water  quality.   Ph.D.  Thesis,
University  of  North  Carolina,  Chapel  Hill.   NC.   156 p.   Available  from
University  Microfilms   International,  Ann  Arbor,  HI.   Publ.  No.  8022514.
(Cited 1n U.S. EPA, 1983)

Sturrock, 3.  1977.  Lack  of mutagenlc effect of halothane  or  chloroform on
cultured  cells  using  the  azaguanlne  test  system.   Br.  3.  Anaesth.   49:
207-210.  (Cited In U.S. EPA, 1982)

Taylor,  D.C., D.M.  Brown,  R.  Kuble  and  P.P.  Langley.  1974.   Metabolism of
chloroform.    II.  A sex  difference  1n  the metabolism  of  14C-chloroform  In
mice.  Xenoblotlca.  4:  165-174.  (Cited  1n U.S.  EPA,  1982)

Thompson, D.J.,  S.D. Warner  and V.B. Robinson.   1974.   Teratology  studies In
orally  administered chloroform  1n  the  rat  and  rabbit.    Toxlcol.   Appl.
Pharmacol.  29:  348-357.  (Cited 1n U.S.  EPA,  1985)

Topham,  J.C.  1980.  Do Induced  sperm-head  abnormalities  In mice  specific-
ally  Identify mammalian  mutagens  rather  than carcinogens?  Mutat.  Res.   74:
379-387.  (Cited 1n U.S. EPA, 1982)

Torkelson, T.R.,  F.  Oyen and  V.K.  Rowe.   1976.   The toxldty  of  chloroform
as  determined by  single and repeated  exposure  of  laboratory  animals.   Am.
Ind. Hyg. Assoc. 3.  37: 697-705.   (Cited In U.S. EPA,  1982)

Tumasonls,  C.F.,  D.N.   McMartln  and B.  Bush.    1985.   Lifetime toxldty  of
chloroform  and  bromodlchloromethane  when administered  over a lifetime  In
rats.  Ectoxlcol.  Environ.  Saf.  8: 233-240.
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Uehleke, H., T. Werner, H.  Grelm  and  M.  Kramer.   1977.   Metabolic activation
of  halothanes  and  tests  j_n  vitro  for  mutagenlclty.   Xenob1ot1ca.   7:
393-400.  (Cited In U.S. EPA, 1982)

U.S. EPA.   1980a.   Ambient  Water  Quality Criteria Document  for  Chloroform.
Prepared by the Office  of  Health  and  Environmental  Assessment, Environmental
Criteria and Assessment Office, Cincinnati,  OH  for  the  Office of  Water Regu-
lations and Standards, Washington, DC.  EPA-440/4-80-033.  NTIS PB 81-117442.

U.S. EPA.   1980b.   Guidelines  and Methodology  Used 1n  the  Preparation  of
Health  Effects Assessment  Chapters  of   the Consent  Decree  Water  Criteria
Documents.  Federal Register.  45: 49347-49357.

U.S. EPA.   1982.   Hazard  Profile  for Chloroform.   Prepared  by the Office of
Health  and  Environmental  Assessment,  Environmental Criteria  and Assessment
Office, Cincinnati, OH for the Office of Solid Waste, Washington,  DC.

U.S. EPA.   1983.   Review  of Toxlcologlc  Data  In Support of  Evaluation  for
Carcinogenic: Potential  of  Chloroform.   Prepared by the  Office of Health  and
Environmental  Assessment,  Carcinogen  Assessment Group,  Washington,  DC  for
the Office of Solid Waste and Emergency Response.

U.S. EPA.   1984.   Methodology and Guidelines for  Reportable Quantity Deter-
minations Based on Chronic Toxldty Data.   Prepared by  the  Office of Health
and Environmental  Assessment, Environmental Criteria and  Assessment Office,
Cincinnati, OH  for the Office  of Solid Waste and  Emergency Response, Wash-
ington, DC.


001 OH                               -33-                             01/20/88

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U.S.  EPA.   1985.  Health  Assessment Document  for  Chloroform.  Prepared  by
the  Office  of  Health  and Environmental  Assessment,  Environmental  Criteria
Assessment Office, Research  Triangle Park, NC.  EPA/600/8-84/004F.   NTIS  PB
86-105004.

U.S.  EPA.   1986.   Guidelines  for  Carcinogen  Risk  Assessment.    Federal
Register.  51(185): 33992-34003.

U.S.  EPA.   1987a.   Integrated  Risk  Information System  (IRIS).   Reference
dose  (RfD)  for  oral  exposure  for  chloroform.   On-Llne:  (Verification  date
12/02/85).   Office of  Health  and  Environmental  Assessment,  Environmental
Criteria and Assessment Office, Cincinnati, OH.

U.S. EPA.  1987b.  Integrated  Risk  Information  System (IRIS).   Risk  estimate
for cardnogenldty for chloroform.  On  Line:   Input  pending.   (Verification
Date 8/26/87).   Office of  Health and Environmental  Assessment,  Environmental
Criteria and Assessment Office, Cincinnati, OH.

von  Oettlngen,  W.F.   1964.  The Halogenated  Hydrocarbons of  Industrial and
Tox1colog1cal Importance.   Elsevler Co.,  Amsterdam,   p.  77-108.  (CHed  1n
U.S. EPA, 1982)

White,  A.E.,  S.  Takehlsa,  E.I. Eger,  S. Wolff  and  W.C.  Stevens.   1979.
Sister chromatld  exchanges Induced by Inhaled  anesthetics.   Anestheslology.
50: 426-430.  (Cited  In U.S.  EPA, 1982)
001 OH                               -34-                             04/13/88

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WHson, J.T., J.F. McNabb, B.H. WHson and M.J.  Noonan.   1983.   Blotransfor-
matlon of  selected  organic pollutants In groundwater.  Dev. Ind. M1crob1ol.
24: 225-233.

WHhey, J.R.,  B.T.  Collins  and  P.G.  Collins.   1982.   Effect  of vehicle on
the  pharmacoklnetlcs  and  uptake  of  four  halogenated  hydrocarbons  from  the
gastrointestinal  tract  of the rat.   Pre-print paper  submitted  to  J. Appl.
Toxlcol.,  December, 1982.  (Cited 1n U.S. EPA, 1985)

Young, T.B.,  M.S. Kanarek and  A.A.  Tslatls.   1981.   Epidemiology  study of
drinking water  chlorlnatlon  and Wisconsin  female cancer mortality.  J. Natl.
Cancer Inst.  67(6): 1191-1198.   (Cited 1n U.S. EPA,  1983)

Zoeteman,  B.C.J., K.  Harmsen,  J.B.H.O.  Llnders, C.F.H. Morra and W.  Slooff.
1980.  Persistent organic  pollutants  In  river water  and  ground water of  the
Netherlands.  Chemosphere.  9:  231-249.
0010H                               -35-                             01/20/88

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