United States
            Environmental Protection
            Agency
            Office of
            Pesticides and Toxic Substances
            Washington DC 20460
March 1981
vvEPA
6-ethoxy-1,2-dihydro-
2,2,4-trimethylquinoline

Ethoxyquin

Pesticide Registration
Standard

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                      ETHOXYQUIN

           Pesticide Registration Standard
Kevin McCormack               Project Manager (SPRD>
Ton Edwards                   Toxicologist (RED)
Arthur Schlosser              Environmental Chemist (HEDX
William Boodee                Residue Chemist (RED)
Ray Kent                      Residue Chemist (RED)
Ed Fite                       Wildlife Biologist (RED1)
Bruce Sidwell                 Plant Physiologist fBFSD)
Dan Dickson                   Product Manager (RD)
Randy Norris                  Writer-Editor (Branch 2)
                     March 1981

      Office of Pesticides and Toxic Substances
           Environmental Protection Agency
                 401 M Street, SW
              Washington, D.C. 20460

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                        TABLE OF CONTENTS

                                                        Page  No.

Chapter One
How to Register Under a Registration  Standard	1

Chapter Two
Agency Position on Ethoxyquin

     Regulatory Position on Ethoxyquin	9
         1.  Introduction	9
         2.  Description of Chemical	9
         3.  Investigation by Other Federal Agencies	9
         4.  Classification under Minor Use	10
         5.  Regulatory Position for  Ethoxyquin...	10
         6.  Regulatory Rationale	10
         7.  Criteria for Registration Under
             this Standard	11

           A.  Manufacturing-use Ethoxyquin....	12
               1.  Acceptable Ranges  and Limits
               2.  Required Labeling

           B.  Emulsifiable Concentrate Ethoxyquin	15
               1.  Acceptable Ranges  and Limits
               2.  Required Labeling

           C.  Impregnated Fruit Wraps	18
               1.  Acceptable Ranges  and Limits
               2.  Required Labeling

          8. Tolerance Reassessment	20

Chapter Three
Data Requirements and Data Gaps

         1.  Manufacturing use Ethoxyquin	21
         2.  Formulated Ethoxyquin Products	21

Chapter Four
Product Chemistry of Ethoxyquin

     A.  Introduction	22

     B.  Manufacturing-use Ethoxyquin	22
         1.  Product Chemistry Profile	22
         2.  Data Requirements	23
         3.  Topical Discussions	23

     C.  Emulsifiable Concentrate Ethoxyquin	25
         1.  Topical Discussions	25

     D.  Impregnated Product Ethoxyquin	26
         1.  Topical Discussions	26

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Chapter Five
Environmental Fate of Ethoxyquin

     A.  Use Profile	28

     B.  Manufacturing-use Ethoxyquin   	29
         1.  Environmental Fate Profile
         2.  Exposure Profile
         3.  Data Requirements and  Data  Gaps
     C.  Formulations of Ethoxyquin   	30
         1.  Exposure Profile

 Chapter  Six
 Toxicology of  Ethoxyquin

     A.  Manufacturing-use  Ethoxyquin.	32
         1.  Toxicology Profile	32
         2.  Data  Requirements  and Data  Gaps	...32
         3.  Topical Discussions	33

     B.  Emulsifiable Concentrate Ethoxyquin	,.44
         1.  Toxicology Profile	44
         2.  Topical Discussions	45

     C.  Impregnated Products	47
         1.  Toxicology Profile	.47

     D.  Supplementary Information	47

 Chapter  Seven
 Residue  Chemistry  of Ethoxyquin

     A.  Manufacturing-use  Ethoxyquin	50
         1.  Residue Chemistry Profile	50
         2.  Data  Gaps	51
         3.  Topical Discussions	51

     B.  Formulated Ethoxyquin	53
         1.  Registration Requirements	53
         2.  Required Labeling	53

Chapter Eight
Ecological Effects of Ethoxyquin

     A.  Ecological Effects Profile	54

Case Bibliography

     A.  Guide to  Use of the  Bibliography	55
           Section I
           Section II

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                         HOW TO REGISTER
                  UNDER A REGISTRATION STANDARD

Organization of the Standard
Purpose of the Standard
Requirement to Re-register Under the Standard
"Product Specific" Data and "Generic" Data
Data Compensation Requirements under FIFRA  3(c)(l)(D)
Obtaining Data to Fill " Data Gaps"; FIFRA  3(c)(2)(B)
Amendments to the Standard

Organization of the Standard

     This first chapter explains the purpose of a Registration  Standard
and summarizes the legal principles involved in registering or  re-
registering under a Standard.  The second chapter sets  forth  the
requirements that must be met to obtain or  retain registration  for  products
covered by this particular Registration Standard.   In  the  remaining
chapters, the Agency reviews the available  data by  scientific discipline,
discusses the Agency's concerns with the  identified potential hazards,  and
logically develops the conditions and requirements  that would reduce  those
hazards to acceptable levels.

Purpose of the Standard

     Section 3 of the Federal Insecticide,  Fungicide,  and  Rodenticide Act
(FIFRA) provides that "no person in any State may distribute, sell, offer
for sale, hold for sale, ship, deliver for  shipment, or receive (and  having
so received) deliver or offer to deliver, to any person any pesticide
which  is not registered with the Administrator  (of  EPA]."  To approve the
registration of a pesticide, the Administrator must find,  pursuant  to
Section 3(c)(5) that:

   "(A)  its composition is  such as  to warrant  the  proposed  claims  for it;
    (B)  its labeling and other material  required to be submitted comply
         with the requirements of  this Act;
    (C)  it will perform its intended function without  unreasonable adverse
         effects on the environment; and
    (D)  when used in accordance with widespread and commonly recognized
         practice it will not generally cause unreasonable adverse  effects
         on the environment."

     In making these findings, the Agency reviews a wide  range  of data
which  registrants are required to  submit, and assesses  the risks  and
benefits associated with the use of  the proposed pesticide.   But  the
established approach to making these findings has been found  to be
defective on two counts:

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      First,  EPA and  its  predecessor  agency,  the United States Department of
 Agriculture  (USDA),  routinely reviewed registration applications on a
 'product by  product'  basis,  evaluating each  product-specific application
 somewhat independently.   In  the  review of products containing similar
 components,  there was  little opportunity for a  retrospective review of the
 full  range of  pertinent  data available in Agency files and in the public
 literature.  Thus the  'product by  product' approach was often inefficient
 and  sometimes  resulted in inconsistent or incomplete regulatory judgments.
      Second, over the  years, as  a  result of  inevitable and continuing
 advances in  scientific knowledge,  methodology,  and policy, the data base
 for many pesticides  came to  be considered inadequate by current scientific
 and  regulatory standards. Given the long history of pesticide regulation
 in  several agencies,  it  is even  likely that  materials may have been lost
 from  the data  files.   When EPA issued new requirements for registration in
 1975  (40 CFR 162) and  proposed new guidelines for hazard testing in 1978
 (43  FR 29686,  July  10, 1978  and  43 FR 37336, August 2, 1978), many products
 that  had already been  registered for years were being sold and used without
 the  same assurances  of human and environmental  safety as was being required
 for new products.   Because of this inconsistency, Congress directed EPA to
 re-register  all previously registered products, so as to bring their
 registrations  and their  data bases into compliance with current
 requirements.   (See  FIFRA Section  3(g)).
      Facing  the enormous job of  re-reviewing and calling-in new data for
 the  approximately 35,000 current registrations, and realizing the
 inefficiencies of the  'product by  product' approach, the Agency decided
 that  a new,  more effective method  of review  was needed.
      A new review procedure  has  been developed.  Under it, EPA publishes
 documents called Registration Standards, each of which discusses a
 particular pesticide  active  ingredient.  Each Registration Standard
 summarizes all the  data  available  to the Agency on a particular active
 ingredient and its  current uses, and sets forth the Agency's comprehensive
 position on  the conditions and requirements  for registration of all
 existing and future  products which contain that active ingredient.  These
 conditions and requirements, all of  which must  be met to obtain or retain
 full  registration or re-registration under Section 3(c)(5) of FIFRA,
 include the  submission of needed scientific  data which the Agency does not
 now have, compliance with standards  of toxicity, composition, labeling, and
 packaging, and satisfaction  of the data compensation provisions of FIFRA
 Section 3(c)(l)(D).
      The Standard will also  serve  as a tool  for product classification.  As
 part  of the  registration of  a pesticide product, EPA may classify each
 product for  "general use" or "restricted use" [FIFRA Section 3(d)].  A
 pesticide is classified  for  "restricted use" when some special regulatory
 restriction  is needed  to ensure  against unreasonable adverse effects to man
 or the environment.  Many such risks of unreasonable adverse effects can be
 lessened if  expressly-designed label precautions are strictly followed.
 Thus  the special regulatory  restriction for  a "restricted use" pesticide is
usually a requirement  that it be applied only by, or under the supervision
of,  an applicator who  has  been certified by  the State or Federal government

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as being competent to use pesticide safely, responsibly,  and  in accordance
with label directions.  A restricted-use  pesticide  can  have other
regulatory restrictions [40 CFR  162.ll(c)(5)]  instead of, or  in addition
to, the certified applicator requirement.  These  other  regulatory
restrictions may include such actions as  seasonal or regional  limitations
on use, or a requirement for the monitoring of residue  levels  after use.
A pesticide classified for "general use," or not  classified at all,  is
available for use by any individual who is in  compliance  with State or
local regulations.  The Registration Standard  review compares  information
about potential adverse effects  of specific uses  of the pesticide with  risk
criteria listed in 40 CFR 162.11(c), and  thereby  determines whether a
product needs to be classified for "restricted use."  If  the  Standard does
classify a pesticide for "restricted use," this determination  is stated in
the second chapter.

Requirement to Re-register Under the Standard

     FIFRA Section 3(g), as amended in  1978, directs EPA  to re-register all
currently registered products as expeditiously as possible.   Congress also
agreed that re-registration should be accomplished  by the use  of
Registration Standards.
     Each registrant of a currently registered product  to which this
Standard applies, and who wishes to continue to sell or distribute his
product in commerce, must apply  for re-registration.  His application must
contain proposed labeling that complies with this Standard.
     EPA will issue a notice of  intent  to cancel  the registration of any
currently registered product to  which this Standard applies if the
registrant fails to comply with  the procedures for  re-registration set
forth in the Guidance Package which accompanies this Standard.

"Product Specific" Data and "Generic" Data

     In the course of developing this Standard, EPA has determined the
types of data needed for evaluation of  the properties and effects of
products to which the Standard applies, in the disciplinary areas of
Product Chemistry, Environmental Fate,  Toxicology,  Residue  Chemistry,
and Ecological Effects.  These determinations  are based primarily on the
data Guidelines proposed in 1978 (43 FR 29696,  July 10, 1978,  and 43 FR
37336, August 22, 1978), as applied to  the use patterns of  the products to
which this Standard applies.  Where it  appeared that data from a normally
applicable Guidelines requirement was actually unnecessary  to  evaluate
these products, the Standard indicates  that the requirement has been
waived.  On the other hand, in some cases studies not required by the
Guidelines may be needed because of the particular  composition or use
pattern of products the Standard covers;  if so, the Standard  explains the
Agency's reasoning.  Data guidelines have not  yet been  proposed for the
Residue Chemistry discipline, but the requirements  for  such data have been
in affect for some time and are, the Agency belives, relatively familiar to
registrants.  Data which we have found  are needed to evaluate  the

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registrability of  some  products  covered  by the Standard may not be needed
for  the  evaluation of other  products,  depending upon the composition,
formulation  type,  and intended uses  of the product in question.  The
Standard  states  which data requirements  apply to which product categories.
(See  the  second  chapter.)  The various kinds  of data normally required for
registration of  a  pesticide  product  can  be divided into two basic groups:

     (A)   data that is " product  specific ," i.e., data that relates only
          to  the  properties or effects  of a product with a particular
          composition (or a group of  products  with closely similar
          composition);  and

     (B)   "generic" data that pertains  to the  properties or effects of a
          particular ingredient,  and  thus is relevant to an evaluation of
          the risks and  benefits  of all products containing that ingredient
          (or all such products having  a  certain use pattern), regardless of
          any such  product's  unique composition.

      The  Agency  requires certain "product specific" data for each product
to characterize  the product's particular composition and physical/chemical
properties  (Product Chemistry),  and  to characterize the product's acute
toxicity (which  is a function of its total composition).  The applicant for
registration or  re-registration  of any product, whether it is a manufactur-
ing-use  or  end-use product,  and  without  regard to its intended use pattern,
must  submit  or cite enough of this kind  of data to allow EPA to evaluate
the  product. For  such  purposes, "product specific" data on any product
other than  the applicant's is irrelevant, unless the other product is
closely  similar  in composition to the  applicant's.  (Where it has been
found practicable  to group similar products for purposes of evaluating,
with  a single set  of tests,  all  products in the group, the Standard so
indicates.)   "Product specific"  data on  the efficacy of particular end-use
products  is  also required where  the  exact formulation may affect efficacy
and where failure  of efficacy could  cause public health problems.
      All  other data needed to evaluate pesticide products concerns the
properties  or effects of a particular  ingredient of products (normally a
pesticidally active ingredient,  but  in some cases a pesticidally inactive,
or "inert,"  ingredient). Some data  in this "generic" category are required
to evaluate  the  properties and effects of all products containing that
ingredient  [e.g.,  the acute  LD-50 of the active ingredient in its technical
or purer  grade;  see proposed 40  CFR  163.81-l(a), 43 FR 37355].
      Other "generic" data are required to evaluate all products which both
contain a particular ingredient  and  are  intended for certain uses (see,
e.g.,  proposed 40  CFR 163.82-1,  43 FR  37363,  which requires subchronic oral
testing of the active ingredient with  respect to certain use patterns
only).  Where a  particular data  requirement is use-pattern dependent, it
will  apply to each end-use product which is to be labeled for that use
pattern (except  where such end-use product is formulated from a registered
manufacturing-use  product permitting such formulations) and to each
manufacturing-use  product with labeling  that  allows it to be used to make

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end-use products with that use pattern.  Thus, for example, a  subchronic
oral dosing study is needed to evaluate the safety of  any manufacturing-use
product that legally could be used to make an end-use,  food-crop
pesticide.  But if an end-use product's label specified it was for  use  only
in ways that involved no food/feed exposure and no repeated human exposure,
the subchronic oral dosing study would not be required  to evaluate  the
product's safety; and if a manufacturing-use product's  label states  that
the product is for use only in making end-use products  not involving
food/feed use or repeated human exposure, that subchronic oral  study would
not be relevant to the evaluation of the manufacturing-use product  either.
     If a registrant of a currently registered manufacturing-use or  end-use
product wishes to avoid the costs of data compensation  [under  FIFRA Section
3(c)(l)(D)] or data generation [under Section 3(c)(2)(B)] for  "generic"
data that is required only with respect to some use patterns,  he may elect
to delete those use patterns from his labeling at the time he  re-registers
his product.  An applicant for registration of a new product under  this
Standard may similarly by request approval for only certain use patterns.

Data Compensation Requirements under FIFRA 3(c)(l)(D)

     Under FIFRA Section 3(c) (1) (D), an applicant for  registration, re-
registration, or amended registration must offer to pay compensation for
certain existing data the Agency has used in developing  the Registration
Standard.  The data for which compensation must be offered is  all data
which is described by all the following criteria:

    (1)  the data were first submitted to EPA (or to its predecessor
         agencies, USDA or FDA), on or after January 1,  1970;
    (2)  the data were submitted to EPA (or USDA or FDA) by some other
         applicant or registant in support of an application for an
         experimental use permit, an amendment adding a new use to  a
         registration, or for registration, or to support or maintain in
         effect an existing registration.
    (3)  they are the kind of data which are relevant to the Agency's
         decision to register or re-register the applicant's product under
         the Registration Standard, taking into account  the applicant's
         product's composition and intended use pattern(s);
    (A)  the Agency has found the data to be valid and  usable  in reaching
         regulatory conclusions; and
    (5)  they are not data for which the applicant has  been exempted by
         FIFRA Section 3(c)(2)(D) from the duty to offer to pay
         compensation.  (This exemption applies to the  "generic" data con-
         cerning the safety of an active ingredient of  the applicant's
         product, not to "product specific" data.  The  exemption is
         available only to applicants whose product is  labeled  for  end-uses
         for which the active ingredient in question is  present in  the
         applicant's product because of his use of another registered
         product containing that active ingredient which he purchases from
         another producer.)

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     An applicant for re-registration of an already  registered  product
under this Standard, or for registration of a  new product  under this
Standard, accordingly must determine which of  the data  used  by  EPA in
developing the Standard must be  the subject of an offer to pay
compensation, and must submit with his application the  appropriate
statements evidencing his compliance with FIFRA Section 3(c)(l)(D).
     An applicant would never be required to offer to pay  for "product
specific" data submitted by another firm.  In  many,  if  not in most cases,
data which is specific to another firm's product  will not  suffice to allow
EPA to evaluate the applicant's product, that  is,  will  not be useful to the
Agency in determining whether the applicant's  product is registrable.
There may be cases, however, where because of  close  similarities  between
the composition of two or more products, another  firm's data may  suffice to
allow EPA to evaluate some or all of the "product  specific"  aspects of the
applicant's product.  In such a case, the applicant  may choose  to cite that
data instead of submitting data from tests on  his  own product,  and if he
chooses that option, he would have to comply with the offer-to-pay
requirements of Section 3(C)(1)(D) for that data.
     Each applicant for registration or re-registration of a manufacturing-
use product, and each applicant for registration  or  re-registration of an
end-use product, who is not exempted by FIFRA  Section 3(c)(2)(D), must
comply with the Section 3(c)(l)(D) requirements with respect to each item
of "generic" data that relates to his product's  intended uses.
     A detailed description of the procedures  an  applicant must follow in
applying for re-registration (or new registration) under this Standard is
found in the Guidance Package for this Standard.

Obtaining Data to Fill "Data Gaps"; FIFRA 3(c)(2)(B)

     Some of the kinds of data EPA needs for its  evaluation  of  the
properties and effects of products to which this  Standard  applies have
never been submitted to the Agency (or, if submitted, have been found to
have deficiencies rendering them inadequate for making  registrability
decisions) and have not been located in the published literature  search
that EPA conducted as part of preparing this Standard.   Such instances of
missing but required data are referred to in the  Standard  as "data gaps".
     FIFRA Section 3(c)(2)(B), added to FIFRA  by  the Congress in  1978,
authorizes EPA to require registrants to whom  a data requirement  applies to
generate (or otherwise produce) data to fill such  "gaps" and submit those
data to EPA.  EPA must allow a reasonably sufficient period  for this to be
accomplished.  If a registrant fails to take appropriate and timely steps

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to fill the data gaps identified by a  section  3(c)(2)(B)  order,  his
product's registration may be  suspended  until  the  data  is submitted. .A
mechanism is provided whereby  two or more  registrants may agree  to share in
the costs of producing data  for which  they are both  responsible.
     The Standard lists, in  its summary  second chapter,  the  "generic"  data
gaps and notes the classes of  products to  which these data gaps  pertain.
The Standard also points out that to be  registrable  under the  Standard,  a
product must be supported by certain required  "product  specific" data.   In
some cases, the Agency may posses sufficient "product specific"  data on  one
currently registered product,  but may  lack such data on another.  Only
those Standards which apply  to a very  small number of currently  registered
products will attempt to state definitively the "  product specific" data
gaps on a 'product by product' basis.  (Although the Standard  will in  some
cases note which data that EPA does possess would  suffice to satisfy
certain "product specific" data requirements for a category  of products
with closely similar composition characteristics.)
     As part of the process  of re-registering  currently registered
products, EPA will issue Section 3(c)(2)(B) directives  requiring the
registrants to take appropriate steps  to fill  all  identified data gaps
whether the data in question is "product specific" or "generic"  in
accordance with a schedule.
     Persons who wish to obtain registrations  for  new products under this
Standard will be required to submit (or  cite)  sufficient  "product specific"
data before their applications are approved.   Upon registration, they  will
be required under Section 3(c)(2)(B) to  take appropriate  steps to submit
data needed to fill "generic"  data gaps.  (We  expect they will respond  to
this requirement by entering into cost-sharing agreements with other
registrants who previously have been told  they must  furnish  the  data.)   The
Guidance Package for this Standard details the steps that must be taken  by
registrants to comply with Section 3(c)(2)(B).

Amendments to the Standard

     Applications for registration which propose uses or  formulations  that
are not presently covered by the Standard,  or  which  present  product
compositions, product chemistry data,  hazard data, toxicity  levels, or
labeling that do not meet the  requirements of  the  Standard,  will
automatically be considered  by the Agency  to be requests  for amendments  to
the Standard.  In response to  such applications, the Agency  may  request
additional data to support the proposed  amendment  to the  Standard, or  may
deny the application for registration  on the grounds that the  proposed
product would cause unreasonable adverse effects to  the environment.  In
the former case, when additional data  have been satisfactorily supplied,
and providing that the data  do not indicate the potential for  unreasonable
adverse effects, the Agency  will then  amend the Standard  to  cover the  new
registration.
     Each Registration Standard is based upon  all  data  and information
available to the Agency's reviewers on a particular  date  prior to the
publication date.  This "cut-off" date is  stated at  the beginning of the

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second chapter.  Any subsequent data submissions and any approved
amendments will be incorporated into the Registration Standard  by means  of
addenda, which are available for inspection at EPA in Washington, B.C.,  or
copies of which may be requested from the Agency.  When all  the present
"data gaps" have been filled and the submitted data have been reviewed,  the
Agency will revise the Registration Standard.  Thereafter, when the  Agency
determines that the internally maintained addenda have significantly
altered the conditions for registration under the Standard,  the document
will be updated and re-issued for publication.
     While the Registration Standard discusses only the uses and hazards of
products containing the designated active ingredient(s), the Agency  is also
concerned with the potential hazards of some inert ingredients  and
impurities.  Independent of the development of any one Standard, the  Agency
has initiated the evaluation of some inert pesticide ingredients.  Where
the Agency has indentified inert ingredients of concern in a specific
product to which the Standard applies, these ingredients will be pointed
out in the Guidance Package.

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                                    II

                  REGULATORY POSITION  ON  ETHOXYQUIN

1.  Introduction

      This chapter is  the central  part  of the  Registration Standard.
  It presents the Agency's regulatory  position and  rationale  based
  on an evaluation of  all registered products  containing  ethoxyquin
  as the sole active ingredient, or in  mixtures with  the  same use
  patterns as described  in this  Standard. After describing the chemical,
  the review of ethoxyquin by  the  Food  and Drug Administration,  and
  the discussion of ethoxyquin's classification as  a  minor use chemical,
  this chapter presents  the regulatory  position and rationale, the
  criteria by which applicants for registration of  ethoxyquin products
  will be approved, including  discussion  of specific  labeling considera-
  tions, and tolerance reassessment.   Thus, this  chapter  contains  all of
  the Agency's requirements for  continued registration  of ethoxyquin
  products and new product registrations  that  are covered by  the Standard.
  Discussions of the data upon which this regulatory  position is based
  are presented in each  of the disciplinary chapters, IV  through VIII.

'2.  Description of Chemical


       Ethoxyquin is the generic name  for 6-ethoxy-l,2-dihydro-2,2,4-
  trimethylquinoline,  used to  control  scald in apples and pears; as a food
  preservative (21 CFR 172.40) to  inhibit color changes in select  spices; as
  a food additive in animal feeds  (21  CFR 573.380)  and  in select dehydrated
  forage crops (21 CFR 573.400).   Scald is a physiological disorder of fruit
  which results in discoloration (browning)  of the  large  areas of  the fruit,
  usually rendering it unfit for the fresh market.  The disorder is super-
  ficial in nature, but  the cosmetic effect is a  significant  factor in
  downgrading fruit during inspection  and culling.
       Only the pesticidal uses of  ethoxyquin  will  be addressed  in  this
  Standard.  Ethoxyquin  is also known  by  the following  trade  names:
  Santoquin, Santoflex AW, Niflex  D, Stop-Scald,  and  Deccoquin.

3.  Investigation by Other Federal Agencies

       It is significant to note that the Food and  Drug Administration (FDA)
  is currently evaluating ethoxyquin as a food additive under its  Cyclic
  Review Program.  Ethoxyquin  is one of 258 direct  food additives which are
  scheduled to undergo review  in order  to evaluate  their  potential  hazard,
  if any, in human food.
       The review currently has 55 color  additives, 258 direct additives,
  and 1332 flavors which are now in Phase II,  or  safety profile  evaluation.
  An "index of concern"  is assigned each  chemical,  based  on review of all

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  toxicity data available on each substance.  The evalxiation of ethoxyquin
  and assignment of a corresponding "index of concern" is scheduled  to  be
  completed in October 1931.
       A review of the FDA data files revealed no major data gaps
  nor any significant inconsistencies in scientific references when  compared
  to the data base compiled by EPA.

4.  Classification Under Minor Use

       low market volume chemicals (usually those with less than 250,000 Ibs.
  active ingredient used per year) and formulated products Cusually  those
  with less than 25,000 Ibs. active ingredient per year) from which  exposure
  is expected to be minimal based on use pattern, available data,  and other
  considerations may be classified by EPA as having minor use status.
       Estimates made by EPA staff indicate that production of ethoxyquin
  during the most recent five year period is less than 30,000 pounds of
  active ingredient in all formulated products per year.  These estimates
  are based on International Trade Commission data, Department of  Commerce
  data and other published sources, as well as contacts with industry
  representatives familiar with this market.
       Accordingly, ethoxyquin is classified as a minor use chemical.   As  a
  result, many data requirements, particularly in the areas of Toxicology,
  Ecological Effects, and Environmental Fate have been waived in this
  Standard.  Waiving these requirements is a result of a thorough  review
  of the uses and subsequent potential exposure to humans and wildlife,
  primarily through the food chain, which indicate exposure to be  minimal.

5.  Regulatory Position for Ethoxyquin

       Ethoxyquin as described in this Standard may be'registered  for sale,
  distribution, reformulation and use in the United States.  The Agency has
  considered the limited amount of scientific data obtained from the open
  literature as of Feb. 11, 1980, and the data submitted by the registrants
  up through the time of publication of this Standard.  In view of this
  information,  the Agency finds that none of the risk criteria found in
  section 162.11(a) of Title 40 of the U.S. Code of Federal Regulations
  have been met or exceeded by ethoxyquin, and that ethoxyquin does  not
  appear to cause an unreasonable adverse effect with proper label
  directions and precautions.
       Ethoxyquin products currently registered may be reregistered  under
  this Standard subject to the conditions imposed by this Standard.
  flew products  may be registered under this Standard and are subject to
  the same requirements.

6.  Regulatory  Rationale

       The Agency has reviewed the data available to it on ethoxyquin.
  Based on this review, the information on ethoxyquin's use patterns,
  methods of application, and the limited poundage active ingredient


                                   10

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 marketed  per  year,  the  Agency has  concluded that ethoxyquin products
 currently registered  nay be re-registered in accordance i/ith the criteria
 set  forth below.

 a. Manufacturing-Use  Ethoxyquin

       Data on  physical and chemical properties and acute toxicity are
 required  for  all  ethoxyquin manufacturing-use products to establish
 the  physical  and  chemical properties and the acute toxicity of the
 active  ingredient.

   b.   Formulated Ethoxyquin

       Emulsiftable concentrate ethoxyquin and impregnated fruit uraps may
   be  registered for use in the United States.

       The  registration is dependent upon filling the data gaps
  listed  in the Tables  in Chapter 3 and identified in the disciplinary
  chapters  for EC ethoxyquin and upon meeting standards for nondomestic use.
       The  outdoor  (spray) uses of ethoxyquin are reportedly no longer
  practiced, but this use still appears on the label.  Lack of data on the
  fate of ethoxyquin in the environment and its toxicity to non-target orga-
  nisms are the basis for Ecological Effects and Environmental Fate data
  requirements  in Chapter 3.  Removal of this use from the label will reduce
  significantly this major route of exposure.  This reduction, coupled with
  the  low probability of accidental spills, flooding, and unintentional dis-
  charge  of wastes  will enable waiving of these data requirements.

7.   Criteria for Registration Under This Standard

       To be subject to this Standard ethoxyquin products must meet the
  following conditions:

  1.  The  product must meet composition standards specified in this Chapter;

  2.  The  product must meet acute toxicity limits specified in this Chapter;

  3.  The  product must meet the labeling standards specified in this Chapter.

       In addition, applicants for registration or reregistration of
  ethoxyquin products subject to this Standard must comply with all terms
  and  conditions described in this Standard including commitment to fill data
  gaps according to the time schedule specified by the Agency and, when
  applicable,  offer to pay compensation to the extent required by Sections
  3(c)(l)(D) and 3(c)(2)(D) of the Federal Insecticide, Fungicide and
  Rodenticide  Act [FIFRAl, as amended, 7 U.5.C. 13fS(c) C H(D) and 136(c) (2)(D),
                                   11

-------
     The following registrants have submitted data in  support of  ethoxyquin
registrations, and have not waived their rights  to compensation  for
this data:  Monsanto Chemical Company, St. Louis, Missouri, and  Crown-
Zellerbach Corporation, San Francisco, California.
A.  Manufacturing-use Ethoxyquin

1.  Acceptable Ranges and Limits

a.  Product Composition Standard

 To be registered under this Standard, manufacturing-use  ethoxyquin
 must comply with the product composition standards developed  in  the
 Product Chemistry chapter (Chapter IV) of this document.   Therefore,
 manufacturing-use ethoxyquin products with any percentage  of  active
 ingredient with appropriate certification of limits are  acceptable under
 this Standard.

b.  Acute Toxicity Limits

     The Agency will consider registration of manufacturing-use ethoxyquin
     products in the following toxicity categories:


                                   	Toxicity Category	
                                   1         II         III       yi_

     Acute Oral Toxicity          YES       YES         YES      YES

     Acute Dermal Toxicity        YES       YES         YES      YES

     Acute Inhalation Toxicity    YES       YES         YES      YES

     Primary Eye Irritation       YES       YES         YES      YES

     Primary Dermal Irritation    YES       YES         YES      YES

c.  Use Patterns

     To be covered under this Standard, manufacturing-use ethoxyquin  must
be formulated into end-use anti-oxidants which are intended  for
nondomestic Indoor or outdoor food uses.  For purposes  of this  Standard,
the term "non-domestic" means applications or uses other than those
outlined in 40 CFR Sec. 162.3(m).
     Data in this Standard that satisfy registration  requirements  may
be cited if the applicant establishes that the proposed product is
                                 12

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substantially similar to another product for which  the Agency has
received acceptable acute toxicity tests.  Data may be cited provided
compensation has been offered to the submitterfs) of  the  data as
explained in Chapter I of this Standard.

2.   Required Labeling

     All manufacturing-use ethoxyquin products nust bear  appropriate
labeling as specified in 40 CFR 162.10.

a.   Use Pattern Statements

     All manufacturing-use ethoxyquin products must list  on  the label  the
intended end-uses of formulated products produced from the manufacturing-
use products.   In accordance with data  to be submitted or cited, all
ethoxyquin product labels must bear one of the following  statements:


     "For formulation into End-use products intended  Only for Non-
     Domestic,  Outdoor Food Use"; or

     For formulation into End-use products intended Only  for Non-
     Domestic,  Indoor Food Use", or

     For formulation into End-use products intended Only  for Non-
     Domestic Indoor or Outdoor Food Use".
For purposes of  this  Standard, the  term "lion-domestic" means  applications
or uses other than  those outlined below [See 40 CFR  162.3(m)l.
     The term "domestic application" means application of a pesticide
directly to humans or pets, or application of a  pesticide in,  on  or
around all structures, vehicles or areas associated with the household
or home life, patient care areas of health related  institutions,  or  areas
where children spend time including but not limited to:
      (1)  Gardens, non-commercial greenhouses, yards,  patios,  houses,
          pleasure marine craft, mobile homes, campers and  recreational
          vehicles, non-commercial campsites, home  swimming pools  and
          kennels;

      (2)  Articles, objects, devices or surfaces handled  or contacted
          by humans or pets in all structures, vehicles or  areas listed
          above;
                                  13

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     (3)  Patient care areas of nursing homes, mental institutions,
          hospitals, and convalescent homes;

     (A)  Educational, lounging and recreational areas of preschools,
          nurseries and day camps.
     Presented below are the types of statements which must appear  on
manufacturing-use ethoxyquin labels.  See 40 CFR 162.10 for specific
required labeling for manufacturing-use products.

b.   PRECAUTIONARY STATEMENTS

     Hazards to Humans and Domestic Animals

     May irritate eyes, nose, throat, and skin.
     Avoid contact with skin, eyes and clothing.

     First Aid Statement

     In case of contact, immediately flush skin or eyes with plenty of
     water.  Get medical attention if irritation persists.  Wash
     thoroughly after using.
     Environmental Hazards

     Do not discharge into lakes, streams, ponds, or public waters un-
     less in accordance with an NPDES permit.  For guidance, contact
     your regional office of EPA.

     Directions for Use

     It is a violation of federal law to use this product in a manner
     inconsistent  with its labeling.  Refer to technical bulletin.

     Storage and Disposal

     Prohibitions

     Do not contaminate water,  food, or feed by storage or disposal.

     Open dumping  is  prohibited.

     Pesticide  Disposal

     Pesticide  or  rinsate that  cannot be used according to label instruc-
     tions must be disposed of  according to state or local procedures
     under the  Resources Conservation and Recovery Act.
                                 14

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     Container Disposal

     Triple rinse (or equivalent) and offer for recycling or  reconditioning
     or dispose of in a sanitary landfill or by approved state and  local
     procedures.

B.  Enulsifiable Concentrate Ethoxyquin

     Applicants for registration or reregistration of formulated
ethoxyquin products are reminded that since no manufacturing-use product
(MUP) is currently registered, fornulators of end-use products are
responsible for providing the data required on the manufacturing-use  pro-
duct in order to comply with the Agency's Proposed Registration Standards
Data Requirements as outlined in Chapter 3.

1.  Acceptable Ranges and Limits

a.  Product Composition Standard

     The Agency will consider for registration emulsifiable concentrate
products which contain ethoxyquin as the sole active ingredient if  the
products meet the acute toxicity standards for nondomestic use, and if the
inert ingredients have been cleared under 40 CFR  180.1001.  The Product
Chemistry, Residue Chemistry and Toxicology data  must be supplied by  the
femulators of end-use ethoxyquin products.

b.  Acute Toxictty Limits

     The Agency will consider registration of any emulsifiable concentrate
(EC) product for non-domestic use in the following categories:

                                             TOXICITY CATEGORY
                                      I           II        III        IV
Acute Oral Toxicity          amendment required*  YES        YES      YES

Acute Dermal Toxicity        amendment required*  YES        YES      YES

Acute Inhalation Toxicity    amendment required*  YES        YES      YES

Primary Eye Irritation       amendment required*  YES        YES      YES

Primary Dermal Irritation    amendment required*  YES        YES      YES

*(Amendment to the Standard)
                                  15

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c.  Use Patterns and Application Methods

     To be registered under this Standard, EC products of ethoxyquin may be
used only as anti-oxidants on apples and pears.

     The Agency finds that currently registered dosage rates  and
application methods are acceptable pending submission of required
chemistry data listed in the manufacturing use section of this  Standard  .

2,  Required Labeling

     All EC ethoxyquin products mist bear appropriate labeling  as  specified
in 40 CFR 162.10.
    PRECAUTIONARY STATEMENTS

     Hazards to Humans and Domestic Animals

     May irritate eyes, nose, throat, and skin.  Avoid breathing
     vapors.  Avoid contact with skin, eyes and clothing.

     First Aid Statement

     In case of contact, flush skin or eyes with plenty of water.
     Get medical attention if irritation persists.  Wash thoroughly
     after using.

     Environmental Hazards

     Do not apply directly to lakes, streams and ponds.
     Do not contaminate water by cleaning of equipment or
     disposal of wastes.
     Directions for Use

     It is a violation of federal law to use this product  in a man-
     ner inconsistent with its labeling.
                                 16

-------
   Currently Registered Application Rates

              APPLES                   PEARS
   1.50-2.25 Ibs. a.i./          1.50-2.25 Ibs. a.i./
   100 gal. water                100 gal. water
   Postharvest Dip or            70% EC
   Spray (70% EC)

   1 part product/               1 part product/200
   200 parts water               parts water (2,700ppm)
   (2,700ppm) 52.2% EC           52.2% EC

   1.00 gal. product/            1.00 gal product/250
   250 gal. water                gal water (2,700ppm)
   (2,700pptn) 59% EC             59% EC

   2.25 Ibs. a.i./lOO gal. water (65.5% EC)
b.  GENERAL INFORMATION

   Post-harvest applications to fruit (dip or spray) should
   include thorough draining of fruit before placement in
   cold storage.  Treatment should not exceed 2 or 3 minutes.
   Preharvest spray to trees should be applied within 2 days
   of harvest.  Application to trees should not be made if
   daily maximum temperature exceeds "5 degrees F. (29.4 C).
   Wet or drench all fruit.

   Storage and Disposal

   Prohibitions

   Do not contaminate water, food, or feed by storage or
   disposal.  Open dumping is prohibited.

   Pesticide Disposal

   Pesticide or rinstate that cannot be used according to label
   instructions must be disposed of according to state or local
   procedures or disposed of under the Resources Conservation and
   Recovery Act.
                               17

-------
     Container Disposal

     Triple rinse (or equivalent) and offer for recycling or recondition-
     ning, or dispose of in a sanitary landfill or by approved state or
     local procedures.

     General

     Consult federal, state or local disposal authorities for
     approved alternative procedures.
C.  Impregnated Fruit Wraps

1.  Acceptable Ranges and Limits

a.  Product Composition Standards

     To be covered under this Standard, fruit XTraps impregnated with
ethoxyquin with any percentage of ingredients are acceptable, provided
residues no greater than 3 ppn. remain on fruit at time of market as a
result of their use.

Inert ingredients must be cleared under 40 CFR 180.1001.

b.  Acute Toxicity Limits

The Agency will consider registration of fruit wraps impregnated with
ethoxyquin in the following categories:

                                           TOXICITY CATEGORY
                                    I            JEI        Til         IV
  Acute Oral Toxicity       amendment required*  YES       YES         YES

  Acute Dermal Toxicity     amendment required*  YES       YES         YES

  Acute Eye Irritation      amendment required*  YES       YES         YES

  Acute Dermal Irritation   amendment required*  YES       YES         YES

  *( Amendment to the Standard)
                                 13

-------
c.  Use Patterns and Application Methods

     To be registered under this Standard, products  impregnated  with
ethoxyquin may be used only as anti-oxidants on  apples  and  pears.   The
Agency finds that current formulation rates and  application methods are
acceptable under this Standard.

2.  Required Labeling

     All impregnated ethoxyquin products must bear appropriate  labeling
as specified in 40 CFR 162.10.

     Presented below are types of  statements which must  appear  on  impreg-
nated ethoxyquin labels.  See 40 CFR  162.10 for  specific  required  label-
ing for formulated products.
    PRECAUTIONARY STATEMENTS



      Hazards  to Humans and Domestic Animals

     May irritate eyes, nose, and  throat.

      Storage  and Disposal

     Do not re-use  fruit wrap.  Dispose of  in  trash  collection.

      Directions for Use

     It is a violation of federal  law  to use  this  product  in  a
     manner inconsistent with its  labeling.


      Currently Registered Application Rates
      Formulation

     0.04% a.i.
     0.131% a.i.
     0.04% a.i.
 Site

Apples



Pears
 Application-Type/Rate

Postharvest wrap.  Wrap
fruit within 1 wk. of
harvest.

(Same as above)
                                  19

-------
  b.  General Warnings and Limitations:

       Do not use impregnated wraps on fruit which has been previously
       treated with ethoxyquin preharvest or postharvest.
       Prolonged exposure of chemical to air or sunlight may result  in
       darkening of the product and staining of the fruit.

8.  Tolerance Reassessment

       Tolerances have been established for residues of ethoxyquin in or  on
  raw agricultural commodities as .indicated:  3 ppm in or on apples  and
  pears (FDA; 40 CFR 180.178).

       Ethoxyquin at 150 ppm or less is added directly to animal feeds (21
  CFR 573.380) and dehydrated forages (21 CFR 573.400), and tolerances for
  residues of ethoxyquin in eggs, meat and meat by-products have been
  established to provide for such feed additive use (21 CFR 172.140).
  Residues from apple and pear waste are unlikely to contribute a significant
  increment of ethoxyquin to the diet of food-producing animals.  In addition
  pears and apples treated post harvest* with ethoxyquin are destined for  the
  fresh market, and little or no processed waste is expected.
     The Theoretical Maximum Residue Contribution (TMRC) of ethoxyquin to
  the human diet from pesticidal uses is calculated to be 0.12 mg/kg/1.5
  kg.diet.  This estimate is based on average adult eating patterns  and on
  the assumption that each commodity contains residues which meet the
  established tolerance level.  The TMRC is based on the above indicated  crop
  tolerances, which can no longer be supported with the inadequate data at
  hand.  There are, however, no data to suggest that maximum dosage  rates on
  currently registered labels would produce residues that would exceed these
  existing tolerances.
       In addition, international (CODEX) tolerances of 3 ppm have been
  recommended for residues of ethoxyquin in or on apples and pears.  The
  U.S. has accepted these maximum residue limits (MRL), which are the same
  as the U.S. tolerances.
       Accordingly, a tolerance reassessment is not possible at this time and
  will instead be performed when the necessary residue data for apples
  and pears are supplied and reviewed.
                                   20

-------
                                 Ill
                   DATA REQUIREMENTS AND DATA GAPS
1.  Manufacturing Use Ethoxyquin

     Applicants for registration of nanufacturing-use ethoxyquin  products
intended to be formulated into acceptable end-uses must cite or subrait
the information identified in the data tables on the physical and chemical
properties, composition, fate and toxicity of the proposed product.  The
Agency will consider both active and inert ingredients in the determination
of substantially similar products.  Before each requirement is listed the
Section of the Proposed Guidelines which describes the type of data and
when it is required (43 FR, No. 132, 29696 of July 10, 1973; and  43 FR,
No. 163, 37336 of August 22, 197S).  Applicants for  the registration
of nanufacturing-use ethoxyquin must submit information identified as data
gaps.
2. Formulated Ethoxyquin Products

     Applicants for registration of EC ethoxyquin products must  cite  or
submit the information listed in the data tables on the product  chemistry
and acute toxicity of the proposed product.  In the event  that an
applicant establishes that a product is substantially similar to another
product for which the Agency has received acceptable acute toxicity tests,
this data may be cited provided compensation has been offered to the  sub-
mitters of these studies.  The Agency will consider both active  and inert
ingredients in making the determination of substantially similar products.
     Applicants for reregistration of impregnated wraps must cite  or
submit information on the product chemistry of the formulation used to
impregnate the wrap.
     Applicants are hereby advised that if the Agency does not receive
commitments within the time frames specified in the data tables  from
manufacturing-use ethoxyquin producers to fill data gaps identified for
the manufacturing-use material, the formulators must then  bear the
burden of supplying the data that would be required to support the re-
registration of their product.
                                  21

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                                                                     TABLE A

                                                        GENERIC DATA REQUIREMENTS AND DATA GAPS
                                                           FOR MANUFACTURING-USE ETHOXYQUIN
Guideline
Citation
Name of Test
Are Data      Test           Does EPA Have Data to      Bibliographic
Required?     Substance      Partially or Totally       Citation
                             Satisfy Requirement?
                                 Must Additional  Data be  Submitted
                                 under FIFRA 3(c)(2)(B)?   If  so,
                                 months allowed for submission.
ENVIRONMENTAL FATE

163.63-7(b)      Hydrolysis            Yes
163.62-8(g)      Activated Sludge      Yes
                 Metabolism

TOXICOLOGY

163.81-1         Acute Oral            Yes
                 Toxtclty
163.81-2         Acute Dermal          Yes
                 Toxic icy
163.81-3         Acute Inhalation      Yes
                 Toxiclty
163.81-4         Primary Eye           Yes
                 Irritation
163.81-5         Primary Dermal        Yes
                 Irritation
163-81-6         Skin Sensltlzation   Yes
                                    Tech. Grade*
                                    Tech. tirade
                                    Tech. Grade*

                                    Tech. Grade

                                    Tech. Grade*

                                    Tech. Grade*

                                    Tech. Grade*

                                    Tech. Grade*
                                    No
                                    No
                                    No

                                    No

                                    Yes

                                    No

                                    No

                                    Yes
Scientific Associates
1960 (MRID 100002202)
Dralze, Woodward and
Calvery (MRID 10500474)
                                 Yes**
                                 No**
Yes: 6 months (Sept. 30, 1981)

Yes: 6 months (Sept. 30, 1981)

No

Yes: 6 months (Sept. 30, 1981)

Yes: 6 months (Sept. 30, 1981)

No
*   Technical Grade  of  the Active  Ingredient
**  If the outdoor spray  use  is dropped from existing labels,  the major route of exposure to
    non-target organisms  will be substantially reduced.   This  reduction, along with the low
    volume use of ethoxyquln  on apples  and pears,  minimal expected exposure, and acceptance
    of the international  CODEX tolerances  will justify waiving the data requirements for
    Hydrolysis.  -Activated Sludge  requirements are being  reserved pending review nad
    modification of  the testing protocols.
                                                                                                                       March 1981

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                                                                TABLE A  (cont.)

                                                       GENERIC DATA REQUIREMENTS AND DATA GAPS
                                                          FOR MANUFACTURING-USE ETHOXYQUIN
Guideline Name of Test
Citation
Are Data
Required?
Teat
Substance
Does EPA Have Data to
Partially or Totally
Satisfy Requirement?
Bibliographic
Citation
Must Additional Data be Submitted
under FIFHA 3(c)(2)(B)? If so,
months allowed for submission.
163.82T1

163.82-2

163.83-1
Subchronic Oral
Toxicity
Subchronic (21 -day)
Denial Toxicity
Chronic Feeding
Yes

Yes

Yes
Tech. Grade

Tech. Grade

Tech. Grade
Yes

Yes

Yea
(See Chapter VI)

(See Chapter VI)

U.S. Agricultural
No

No

No***
                                                                                       Research Service.,
                                                                                       Western Utilization
                                                                                       Research Branch (MRID
                                                                                       10001923)
                                                                                       Wilson and De Eds (MRID
                                                                                       105000474)
                                                                                       Fanner end Packer
                                                                                       (MRID 005000529)
                                                                                       Rudra, Dickerson and
                                                                                       Walker (MRID 105000419)
                                                                                       Banzai (MRID
                                                                                       #00001925)
                                                                                       Colorado ASM Uni.
                                                                                       (MRID 100001919)
                                                                                       Cassner, Buss,
                                                                                       Hopwood and Thompson
                                                                                       (MRID 105000517)
                                                                                       Pascal (review article)
                                                                                       (MRID 105000412)
** Although data are not available to reassess tolerances, a new study is not being
   required at this time because of the low volume use of ethoxyquin on apples and
   pears,  minimal expected exposure, and acceptance of the International CODEX tolerances.
March 1981

-------
                                                               TABLE A (cent.)

                                                      GENERIC DATA REQUIREMENTS AND DATA GAPS
                                                         FOR MANUFACTURING-USE ETHOXYQUIN
Guideline Name of Test
Cleat loo
Are Data
Required?
Test
Substance
Does EPA Have Data to
Partially or Totally
Satisfy Requirement?
Bibliographic
Citation
Must Additional Data be Submitted
under FIFRA 3(c)(2)(B)? If so,
months allowed for submission.
163.83-2

163.83-3
163.83-4
Oncogeniclty

Teratogenicity
Reproduction
Yes

Yes
                                        Yes
Tech. Grade

Tech. Grade
              Tech. Grade
Yes
                                                                            Yes
                      Yes
Wilson and De Eds (MRID
#05000474)
Telfolrd, I.R. et al.
(MRID #05000428)
Wilson, R.H. (MRID
100001933)
Isensteln, R.S.
(MRIU 005000366)
Monsanto Company (MRID
#00001919)
Monsanto Company (MRID
#00001920)
Wilson, R.H. (MRID
#00001933)
Wilson, R.H. (MRID
#00001934)
Wisconsin Alumni Ass'n.
(MRID #00001924)
Amer. Jour, of Anatomy
(MRID #05000428)
Aoer. Jour, of Vet. Res.
(MRID #05000366)
Journal of Food and Ag.
Chemistry (MRID #05000474)
No
                                                                                  No
                                                                                                                          No
                                                                                                                                             March 1981

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                                                             TABLE A (cont.)

                                                      GENERIC DATA REQUIREMENTS AND DATA GAPS
                                                         FOR MANUFACTURING-USE ETHOXYQUIN
Guideline Name of Teat
Citation
Are Data
Required?
Test
Substance
Does EPA Have Data to
Partially or Totally
Satisfy Requirement?
Bibliographic
Citation
Must Additional Data be Submitted
under FIFRA 3(c)(2)(B)7 If so,
months allowed for submission.
163.84-1-4

163.85-1
Mutagenicity

Metabolism
Yes

Yes
Tech. Grade

Tech. Grade
Yes

Yea
PRODUCT CHEMISTRY
163.61-8(1)
163.61-8(2)
163.61-8(4)
163.61-8(5)
163.61-8(6)
163.61-8(7)
Color
Odor
Solubility
Stability
Octanol/Water
Partition
Coefficient
Physical State
                      Yes
Yes
Yes
Yes
Yes
Yes
              Tech. Grade*
Tech. Grade
Tech. Grade
Tech. Grade
Tech. Grade
Tech. Grade
                      Yes
No
No
No
No
Yes
Joner, P.E. (MRID
105000385)
Wilson, 1959 (MRID
#05000475)
Monsanto (MRID
100001935)
TerMeulin and Walker
(MRID 105002491)
Skaare, J.V. and Natstad, I.
(MRID 105012506)
             Monsanto'Chen.  Co.
             (MRID I004X)
             Rexolln Chen. Co.
             (MRID I006X)
                                                                    No
                                                                Co.
             Monsanco Chen.
             (MRID 0004X)
             Rexolln Chem. Co.
             (MRID I006X)
                                 No
                                 Yes: 6 months (Sept. 30, 1981)
                                 Yest 6 months (Sept. 30, 1981)
                                 Yes: 6 months (Sept. 30, 1981)
                                 Yest 6 months (Sept. 30, 1981).
                                                                                  No
*  Technical Grade of the Active Ingredient
                                                                                                                          March 1981

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                                                              TABLE A (cont.)

                                                     GENERIC DATA REQUIREMENTS AND DATA GAPS
                                                        FOR MANUFACTURING-USE ETHOXYQUIN
Guideline
Citation
Name of Test
Are Data
Required?
Test
Substance
Does EPA Have Data to Bibliographic
Partially or Totally Citation
Satisfy Requirement?
Must Additional Data be Submitted
under FIFRA 3(c>(2)(B)7 If so,
•oaths allowed for submission.
RESIDUE CHEMISTRY
N.A.**
N.A.



ECOLOGICAL
163.71-1

163.71-2

163.72-1

163.72-2
Degradation Pathway
Residues on Apples
and Pears from
MAXIMUM registered
uses
EFFECTS
Avian Single
Dose Oral LDSO
Avian Dietary
LC50
Fish Acute
LC50
Acute To xi city
Yes
Yes




Yes

Yes

Yes

Yes
Tech. Grade
Tech. Grade




Tech. Grade*

Tech. Grade*

Tech. Grade*

Tech. Grade*
No
No




No

No

No

No
Yes: 12 months (March 31
Yes: 12 months (March 31




Yes**

Yes**

Yes**

Yes**
, 1981)
, 1981)











                  to Aquatic  Invertebrates
*  Technical Grade of  the Active  Ingredient
** Data Requirements are waived because  of low market volume, use patterns and application
   methods for ethoxyquln.
** N.A. - Not applicable.
March 1981

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                                                                     TABLE B

                                                    PRODUCT-SPECIFIC DATA REQUIREMENTS AND DATA GAPS
                                                      FOR MANUFACTURING-USE ETHOXYQUIN PRODUCTS
Guideline
Citation
Name of Test
Are Data Test Does EPA Have Data to Bibliographic Must Additional Data be Submitted
Required? Substance Partially or Totally Citation under FIFRA 3(c)(2)(B)T If so.
Satisfy Requirement? months allowed for submission.
PRODUCT CHEMISTRY
163.61-3


163.61-4


163.61-5


163.61-6

163.61-7

163.61-8(7)
163.61-3(8)

163.61-8(11)
163.61-8(12)
Prod. Identity
and Disclosure
of Ingredients
Description of
Manufacturing
Process
Disc, of Format
of Unlnt.
Ingredients
Declaration of
Ingredient Limits
Product Analyt.
Methods and Data
Physical State
Density or
Specific Gravity
PH
Storage Stab.
Yes


Yes


Yes


Yes

Yes

Yes
Yes

Yes
Yes
Each MUP*


Each MUP*


Each MUP*


Each MUP*

Each MUP*

MUP**
MUP**

MUP**
MUP***
No


No


No


No

No

No
No

No
No
Yes: 6 months -(Sept.


Yes: 6 months (Sept.


Yes: 6 months (Sept.


Yes: 6 months (Sept.

Yes: 6 months (Sept.

Yes: 6 months (Sept.
Yes: 6 months (Sept.

Yes: 6 months (Sept.
Yes: 6 months (Sept.
30, 1981)


30. 1981)


30, 1981)


30, 1981)

30. 1981)

30, 1981)
30, 1981)

30. 1981)
30. 1981)
* Each Manufacturing-use Product.
** Required ft
>r Manufacturing-use Pr
oducts whic
:h are not the same at
i the Technical Grade


    for the Active Ingredient.  Product Chemistry data requested In TABLE-A will suffice for
    Manufacturing-use Ethoxyquln because It Is equivalent to Technical Grade Ethoxyquin.
*** Each manufacturing-use Product or Substantially Similar Product.
March 1981

-------
                                                                         TABLE B (conC.)

                                                    PRODUCT-SPECIFIC DATA REQUIREMENTS AND DATA GAPS
                                                      FOR MANUFACTURING-USE ETHOXYQUIN PRODUCTS
Guideline
Citation
Naoe of Teat
Are Data      Teat           Does EPA Have Data to      Bibliographic
Required?     Substance      Partially or Totally       Citation
                             Satisfy Requirement?
                                                                                                        Must Additional Data be Submitted
                                                                                                        under FIFRA 3(c)(2)(B)7  If so,
                                                                                                        months allowed for submission.
TOXICOLOGY
163.81-1

163.81-2

163.81-3

163.81-4

163.81-5

163.81-6


Acute Oral
Toxicity
Acute Denial
Toxicity
Acute Inhal.

Prim. Eye
Irritation***
Primary Dermal
Irritation
Dermal
Sensitizatlon

Yes

Yes

Yes

Yes

Yea

Yes


HBP*

MUP*

MUP**

MOP**

MOP**

MDP**


Ho

No

Yes

Ma

No

Yes






Scientific Associates, 1960
(MRID 100002202)




Draize, Woodward and
Calvery (MRID 105000474)

Yes:

Yes:

No

Yes:

Yes:

No


6 mouths (Sept.

6 months' (Sept.



6 months (Sept.

6 months (Sept.




30, 1981)

30, 1981)



30, 1981)

30, 1981)



*   Required for Manufacturing-use Products which are not  the same as the Technical Grade
    of the Active Ingredient.  Acute Oral and Dermal Toxicity data requested in TABLE-A will
    provide needed data for Manufacturing—use Ethoxyqin because the MUP is equivalent to
    Technical Grade Etboxyquin.
**  Each Manufacturing-use Product or Substantially Similar Product.
*** A demonstration of pH between 1 and 3, or 12 and 14 or a demonstration of denial irritability
    will be sufficient to categorize a product aa an ocular Irritant, and additional testing will
    •not be required.
                                                                                                                   March 1981

-------
                                                                    TABLE  C

                                                    PRODUCT-SPECIFIC DATA  REQUIREMENTS AND DATA GAPS
                                                    FOR EMULSIFIABLE CONCENTRATE ETHOXYQUIN PRODUCTS
Guideline
Citation
Mane of Test
Are Data Test Does EPA Have Data to Bibliographic Must Additional Data be Submitted
Required? Substance Partially or Totally Citation under FIFRA 3(c)(2)(B)7 If so.
Satisfy Requirement? Booths allowed for submission.
PRODUCt CHEMISTRY
163.61-3


163.


163.


163.

163.

163.
163.
163.
163.

'.63.
363.


61-4


61-5


61-6

61-7

61-8(1)
61-8(2)
61-8(7)
61-8(8)

61-8(11)
61-8(12)
Prod. Identity
and Disclosure
of Ingredients
Description of
Manufacturing
Process
Disc, of Format
of Unlnt.
Ingredients
Declaration of
Ingredient Limits
Product Analyt.
Methods and Data
Color
Odor
Physical State
Density or
Specific Gravity
pH
Storage Stab.
Yes


Yes


Yes


Yes

Yes

Yes
Yes
Yes
Yes

Yes
Yes
Each B.C.


Each E.C.


Each E.C.


Each E.C.

Each E.C,

Each E.C.
Each E.C.
Each E.C.
EC**

EC**
EC**
Product*


Product*


Product*


Prodcut*

Product*

Product*
Product*
Product*




Ho


No


No


No

No

No
No
No
No

No
No
Yes:


Vest


Yes:


Yea:

Yes:

Yes:
Yes:
Yes:
Yes:

Yes:
Yes:
6 months


6 months


6 nonths


6 nonths

6 months

6 nonths
months
Bonths
•ontha

wraths
months
(Sept.


(Sept.


(Sept.


(Sept.

(Sept.

(Sept.
(Sept.
(Sept.
(Sept.

(Sept.
(Sept.
30.


30,


30,


30,

30,

30,
30,
30,
30,

30,
30,
1981)


1981)


1981)


1981)

1981)

1981)
1981)
1981)
1981)

1981)
1981)
  Each Emulsiftable Concentrate Product.
* Each Emulslfiable Concentrate Product or Substantially Similar Product
March 1981

-------
                                                                 TABLE C (cont.)

                                                    PRODUCT-SPECIFIC DATA REQUIREMENTS AND DATA GAPS
                                                    FOR EMULSIFIABLE CONCENTRATE ETUOXYQUIN PRODUCTS
Guideline
Citation

TOXICOLOGY
163.81-1

163.81-2

163.81-3

163.81-4

163.81-5

163.81-6


Name of Test


Acute Oral
Toxlclty
Acute Deroal
Toxlclty
Acute Inlial.
Toxiclty
Pr In. Eye
Irritation**
Primary Deraal
Irritation
Denial
Senaltlzatlon

Are Data Teat
Required t Substance

Yea EC*

Yea EC

Yea EC

Yea EC

Yea EC

Yea EC


Does EPA Have Data to Bibliographic
Partially or Totally Citation
Satlafy Requirement t
Yea Younger, 1960 (MRID
100001880)
Yea Younger, 1960 (MRID
100001884)
Yea Scientific Aaaoclatea, 1960
(MRID JGS-0003-4)
Yea Younger, 1960 (MRID
100001884)
Yea Younger, 1960 (MRID
100001884)
Yea See Supplementary
Intonation Top lea
(Chapter VI)
Muet Additional Data be Submitted
under PIFRA 3(c)(2)(B)T If ao,
•ontha allowed for submission.
No

No

No

No

No

No


*  Each Enulslflable Concentrate Product or Substantially Similar Product.
** A demonstration of pH between 1 and  3, or  12 and 14 ojr a demonstration of denial
   Irritability will be sufficient to categorlce a product aa an ocular Irritant,
   and additional teatlng will not be required.
March 1981

-------
                                                                    TABLE  D


                                                     PRODUCT-SPECIFIC  DATA REQUIREMENTS AND DATA GAPS
                                                          FOR IMPREGNATED  ETHOXYQUIN PRODUCTS
Guideline
Citation
Name of Test
Are Data Test Does EPA Have Data to Bibliographic
Required? Substance Partially, or Totally Citation
Satisfy Requirement?
Must Additional Data be Submitted
under FIFRA 3(c)(2)(B)7 If so,
months allowed for submission.
PRODUCT CHEMISTRY
163


163


163


163

163

163
163
163
163

163
163
163
163
.61-3


.61-4


.61-5


.61-6

.61-7

.61-8(1)
.61-8(2)
.61-8(7)
.61-8(8)

.61-8(9)
.61-8(10)
.61-8(11)
.61-8(12)
Prod. Identity
and Disclosure
of Ingredients
Description of
Manufacturing
Process
Disc, of Format
of Unlnt.
Ingredients
Declaration of
Ingredient Limits
Product Analyt.
Methods and Data
Color
Odor
Physical State
Density or
•Specific Gravity
Boiling Point
Vapor Pressure
PH
Storage Stab.
NOTE: If registrants can demonstrate
Yes


Yes


Yes


Yes

Yes

Yes
Yes
Yes
Yes

Yes
Yes
Yes
Yes
that
Each IMP Product*


Each IMP Product*


Each IMP Product*


Each IMP Product*

Each IMP Product*

Each IMP Product*
Each IMP Product*
Each IMP Product*
IMP**

IMP**
IMP**
IMP**
IMP**
the material used to Impregnate
No


No


No


No

No

No
No
No
No

No
No
No
No
wraps Is substantially similar to the
Yes:


Yes:


Yes:


Yes:

Yes:

Yes:
Yes:
Yes:
Yes:

Yes:
Yes:
Yes:
Yes:
technical
6


6


6


6

6

6
6
6
6

6
6
6
6

months


months


months


months

months

months
months
months
months

months
months
months
months

(Sept.


(Sept.


(Sept.


(Sept.

(Sept.

(Sept.
(Sept.
(Sept.
(Sept.

(Sept.
(Sept.
(Sept.
(Sept.

30,


30.


30,


30,

30,

30,
30,
30,
30,

30.
30,
30.
30,

1981)


1981)


1981)


1981)

1981)

1981)
1981)
1981)
1981.

1981)
1981)
1981)
1981)

*  Each Impregnated Product.
** Each Impregnated Product or Substantially Similar Product
March 1981

-------
                                                                 TABLE D (cont.)

                                                    PRODUCT-SPECIFIC DATA REQUIREMENTS AND DATA GAPS
                                                         FOR IMPREGNATED ETHOXYQUIN PRODUCTS
Guideline
Citation
Name of Test
Are Data Test
Required? Substance
Does EPA Have Data to Bibliographic Must Additional Data be Submitted
Partially or Totally Citation under FIFRA 3(c)(2)(B)7 If so.
Satisfy Requirement? months allowed for submission.
TOXICOLOGY
163.

163.

163.

163.

163.

163.

81-1

81-2

81-3

81-4

81-5

81-6

Acute Oral
Toxicity
Acute Dermal
Toxicity
Acute Inhal.
Toxicity
Prim. Eye
Irritation**
Primary Dermal
Irritation
Dermal
Sensltization
Yes

Yea

Yes

Yes

Yes

Yes

IMP*

IMP

IMP

IMP

IMP

IMP

Ho

No

No

No

No

No

Yes:

Yes:

Yes:

Yes:

Yes:

Yes:

6

6

6

6

6

6

months

months

months

months

months

months

(Sept.

(Sept.

(Sept.

(Sept.

(Sept.

(Sept.

30,

30.

30.

30.

30.

30,

1981)

1981)

1981)

1981)

1981)

1981)

NOTE;  If registrants can demonstrate that  the material used to Impregnate wraps is substantially similar to the technical
       or manufacture-use formulations, the toxicology data requirements for the impregnated wraps will be waived.
*  Each Impregnated Product or Substantially Similar Product.
** A demonstration of pH between  1 and  3, or 12 and 14 £r_ a demonstration of dermal
   irritability will be sufficient to categorize a product as an ocular Irritant.
   and additional testing will not be required.
March 1981

-------
                                   IV

                           PRODUCT CHEMISTRY
A.  Introduction

     FIFRA 3(c)(2)(A) requires the Agency  to establish guidelines  for  regis-
tering pesticides in the United States.  The Agency requires
registrants to provide quantitative data on all added ingredients,  active
and inert, which are equal to or greater than 0.1% of the product  by
weight.  A review of the "confidential  statement of formula  for  the end-use
products of Ethoxyquin indicates that all  inert ingredients are  cleared
under CFR 40 Part I Sec. 180.1001.
     To establish the composition of products proposed for registration,
the Agency requires data and information not only on the manufacturing and
formulation processes but also a discussion on the formation  of
manufacturing impurities and other product ingredients, intentional and
unintentional.  Further, to assure that the composition of the product as
marketed will not vary from the composition evaluated at the  time  of
registration, applicants are required to submit a statement certifying
upper and lower composition limits for  the added ingredients, or upper
limits only for some unintentional ingredients.  Subpart D of the  Proposed
Guidelines (43 FR 29696, July 10, 1978) suggests specific precision limits
for ingredients based on the percentage of ingredient and the degree of
accuracy of the analytical method.
     In addition to the data on product composition, the Agency  guidelines
also require data to establish the physical and chemical properties of both
the pesticide active ingredient and its formulations.  For example, data
are needed concerning the identity and  physical state of the  active
ingredient (e.g., melting and boiling point data, ambient vapor  pressure
and solubility).  Data are also required on the properties of the
formulated product to establish labeling cautions (e.g., flammability,
corrosiveness or storage stability).  The Agency uses these data to
characterize each pesticide and to determine its environmental and  health
hazards.

B.  Product Chemistry - Manufacturing-Use Ethoxyquin

  1.  Product Chemistry Profile

     No manufacturing use products containing ethoxyquin are  currently
registered.  Applicants for registration of ethoxquin products are
reminded that since no manufacturing use products are currently  registered,
the formulators are responsible for supplying the required data
for the manufacturing-use chemical as outlined in Chapter 3.
                                 22

-------
     Because it is considered "Confidential Business  Information",  a
discussion of the specific procedures, equipment, and manufacturing
conditions required for the commercial production of  the chemical will  not
be included in this standard.
     The Farm Chemicals Handbook 1980 shows Monsanto  Company,  the only
basic U.S. producer of Ethoxyquin, as having discontinued  production
of the 70% Emulsifiable Concentrate formulation.  Contact  with industry
also indicates that, along with- the discontinuance of the  pre-harvest
spray use, most of the other uses of ethoxyquin with  the exception  of
the impregnated wraps have been abandoned.
     A small amount of data are available pn the physical  and  chemical
properties of technical ethoxyquin.  See Data Tables  in Chapter  3.

  2.  Data Requirements

     Refer to Chapter 3 for Product Chemistry data needed  to support
the registration of any manufacturing-use ethoxyquin  product.  Following
each data requirement is  the section in the Proposed  Guidelines  for the
Registration of Pesticides in the United States (43 FR 29696,  July  10,
1978) that describes the  type of data required.  The  applicant for
registration must submit  or cite this information.

  3.  Topical Discussions

     Corresponding  to each of the Topical Discussions listed below  is  the
number of the section in  the 'Proposed Guidelines for Registering
Pesticides' in the United States (43 FR 29696, July 10, 1978)  which
explains the minimum data that the Agency requires in order to adequately
assess Product Chemistry  of manufacturing-use ethoxyquin products.  Also
under each of the following topics is a reference to  the appropriate
section in the 'Proposed  Guidelines'.

                                                   Guidelines  Section

Chemical Identity 	 163.61-3
Manufacturing Processes 	 163.61-4
Formation of Unintentional
  Ingredients 	 163.61-5
Active Ingredient Limits  in
  Pesticide Products 	 163.61-6
Product Analytical Methods and Data 	 163.61-7
Physical/Chemical Properties 	 163.61-8

Chemical Identity [163.61-3(c)]

     The Proposed Guidelines require identifying information including
chemical names, product names, and numerical codes of all  substances known
or assumed to be present  in pesticide products.  See  tables  in Chapter  3.


                                 23

-------
     "Ethoxyquin" is the generic name for 6-ethoxy-l,2-dihydro-2,2,4-
trimethyl-quinoline.  Ethoxyquin is a derivative of quinoline.  Trade
names for Ethoxyquin are: Santoquin, Santoflex AU, Niflex D,  Stop-scald,
and Deccoquin.  The name "Ethoxyquin" will be routinely used  in this
standard in lieu of other chemical or trade nanes.

Manufacturing Processes  f163.61-4(b)1

     Because the route by which a pesticide is synthesized determines  the
nature and amount of potentially toxic impurities, a detailed description
of the manufacturing process is required.

Formation of Unintentional Ingredients [153.61-5]

     Section 163.61-5 of the Proposed Guidelines requires registrants  of
manufacturing-use and of formulated products to submit a theoretical
discussion of the formation of unintended substances in the product.
     A theoretical discussion of the formation of unintended  substances has
not been submitted for manufacturing-use ethoxyquin.  Such a discussion is
required for each manufacturing-use product.

Active Ingredient Limits in Pesticide Products [163.61-61

     The Guidelines require that upper and lower limits be established for
each active ingredient and each intentionally added inert in  a pesticide
product.  Technical ethoxyquin contains approximately 95" of  the
pure chemical.
     Upper and lower limits have not been established and certified for
technical ethoxyquin.

Product Analytical Methods and Data H63.61-71

     The Guidelines require submission of, or reference to, analytical
methods for measuring each active ingredient in a pesticide product.
     Section 163.61-7 of the Proposed Guidelines also require that
applications for registration of pesticide products contain analytical data
obtained by methods supplied to the Agency.
     Adequate analytical methods for the identification and quantification
of Ethoxyquin in the technical and formulated end-use product have not been
submitted.  Acceptable methods for the analysis of impurities also have not
been submitted.  The manufacturer, i.e., Monsanto, did not report I.R. or
U.V. spectra which could be used in the identification of Ethoxyquin.

Physical and Chemical Properties [163.61-nl

     For every pesticide product, the Proposed Guidelines require data on
certain physical and chemical properties useful for identification purposes
or for evaluation of hazard potential.

-------
      A small amount of data are available on the physical and chemical
 properties of ethoxyquin.  Available data on purified ethoxyquin  (Monsanto,
 1975, MRID #004X; Rexolin Chemicals, 1971, MRID #006X) give these details:

     Color; Varies from yellow to brown.  Darkens when exposed to  light or
              air.
     Boiling Point:  125°C at 2 mm Hg.
     Density or Specific Gravity;  1.03 at 25°C
     Physical State;  Technical ethoxyquin is a liquid when purified.
     Flammability;  Flash point 285-290°F (COG) and >175°F (TCC)

C.  Product Chemistry - Emulsifiable Concentrate Ethoxyquin

      See the Tables in Chapter 3 for a complete listing of the Data
 Requirements and Data Gaps for EC ethoxyquin.

  1.  Topical Discussions

      The product chemistry of ethoxyquin has been dealt with in the
 Manufacturing-Use Ethoxyquin section of this chapter.  The following are
 data required of all EC formulated products of ethoxyquin.

   Active Ingredient Limits in Pesticide Products [163.61-5]

      For all pesticide products, the Guidelines would require that upper
 and lower limits be established for each active ingredient, impurity,
 reaction product, and degradation product.
      Current registrations of EC ethoxyquin contain 52.2, 59.0, 65.5, and
 70% active ingredient.

 Product Analytical Methods and Data [163.61-7]

      The Guidelines would require submission of, or reference to,
 analytical methods measuring each active ingredient in a pesticide
 product.
      Section 163.61-7 of the Proposed Guidelines would require that
 applications for registration of pesticide products contain analytical data
 obtained by methods supplied to the Agency.  Data obtained by the method
 described above have not been submitted.
      Section 163.61-7 of the Proposed Guidelines would also require that
 registrants of formulated products produced by an integrated formulation
 system (Proposed Guidelines, section 163.61-1) submit methods not only for
 the active ingredient, but for each identifiable impurity associated with
 manufacture of the technical chemical.  Such methods have not been
 submitted for any ethoxyquin formulation.
                                  25

-------
 Physical and Chemical Properties [163.61-8]

      For every pesticide product, the Proposed Guidelines would require
 data on certain physical and chemical properties useful for  identification
 purposes or for evaluation of hazard potential.
      The following physical and chemical properties are required  for  all  EC
 products of ethoxyquin.  No data have been submitted.
      Required Physical/Chemical Properties:  Color, odor, density or
 specific gravity, pH, storage stability, flammability, oxidizing  or
 reducing action, explosiveness, and corrosion characteristics.

D.  Product Chemistry - Impregnated Product Ethoxyquin

      See Tables in Chapter 3 for the Data Requirements and Data Gaps
 corresponding to the impregnated formulation.

 1. Topical Discussions

      Registrants are advised that if some formulation other  than  the
 technical or manufacturing-use product is used in the manufacture  of
 impregnated wraps, the aforementioned data requirements must be fulfilled
 for that formulation.
      The product chemistry of ethoxyquin per ££ has been dealt with in the
 Manufacturing-use Ethoxyquin section of this chapter.  The following are
 data required of all impregnated formulated products of ethoxyquin.

 Active Ingredient Limits in Pesticide Products [163.61-51

      For all pesticide products, the Guidelines would require that upper
 and lower limits be established for each active ingredient,  impurity,
 reaction product, and degradation product.
      Current federal registrations of impregnated ethoxyquin products
 contain 0.04 to 0.131% a.i.
      An upper and lower limit for wraps impregnated with ethoxyquin has
 not been established.

 Product Analytical Methods and Data [163.61-7]

      The Guidelines would require submission of,  or reference to,
 analytical methods measuring each active ingredient in a pesticide
 product.
      Section 163.61-7 of the Proposed Guidelines would require that
 applications for registration of pesticide products contain analytical data
 obtained by methods supplied to the Agency.
      Section 163.61-7 of the Proposed Guidelines would also require that
 registrants of formulated products produced by an integrated formulation
 system (Proposed Guidelines, section 163.61-1) submit methods not  only for
                                  26

-------
the active ingredient, but for each identifiable impurity associated with
manufacture of the technical chemical.  Such methods have not  been
submitted for any ethoxyquin formulation.

Physical and Chemical Properties  [163.61-81

     For every pesticide product, the Proposed Guidelines would require
data on certain physical and chemical properties useful  for  identification
purposes or for evaluation of hazard potential. Data on  the  physical and
chemical properties of substances used to  impregnate wraps are required if
the substance is not substantially similar to a product  for  which the
Agency has acceptable data.
     Required Physical/Chemical Properties:  Color, odor, density or
specific gravity, pH, 'storage stability, flammability, oxidizing or
reducing action, explosiveness, and corrosion characteristics.
                                 27

-------
                                   V

                            ENVIRONMENTAL FATE
A.  Use Profile

     Ethoxyquin formulations are applied to apples and  pears  by  pre-
harvest spray and post-harvest dip or spray.  Ethoxyquin is also
impregnated on paper wrappings to prevent scald, post-harvest.
     There are two types of ethoxyquin products currently registered  to
treat apple and pear scald.  Five companies have labels for enulsifiable
concentrates containing from 52.2 to 70% active ingredient.
     Current registrations for ethoxyquin include "No Scald Ethoxyquin"
(Chemley Products Co., EPA registration number 4543-9) and "Deccoquin 305
Concentrate" (Pennwalt Corp., EPA Registration number 4581-316), basically
dominating the market where drenches, sprays, dips, and waxes are used.
Both are available in 5 gal. cans ready to dilute with water  in  treatment
tanks.  Two companies have labels for paper wraps.  Only one  company
(Crown Zellerbach) still actively markets its wraps; "Crownoil Apple  Wraps"
(EPA registration number 3222-9), "Green Crownoil Pear Wraps" (EPA
registration number 3222-6). The wraps are available as individual  sheets
ranging in size from 9 x 9 to 14 x 12 inches.  All of the above  formulators
apparently obtain their ethoxyquin from the primary manufacturer, the
Monsanto Company.
     State and Federal recommendations and other literature sources list
preharvest and postharvest sprays, postharvest drenches and dips, wax dips,
and paper wraps as means for treating fruit with ethoxyquin.  In current
practice preharvest sprays are apparently not used.  The most commonly used
treatment method is a fruit drench in an ethoxyquin aqueous solution  at the
packinghouse.  In this method bulk bins of recently harvested fruit are
flooded for several seconds with the treatment then allowed to drain  for a
few minutes before removal (usually by forklift) to cold storage.   Excess
solution is recovered and recycled for immediate re-use.  Recommended
ethoxyquin concentrations are between 2000 to 2700 ppm active ingredient.
The solution often contains a surfactant and an antifearning agent.  It is
also normal practice to add one or more antirot fungicides to the mix such
as captan (1 lb/100 gal) and/or benlate (6-8 oz/100 gal).
     A small number of packinghouses dip their harvested apples  in  similar
solutions.  Typically a forklift places a bulk bin into a tank of
ethoxyquin for a period of 15 seconds to 2 minutes, depending on the
temperature of the solution.  In all application types, fruit are only
treated once.
     Accurate data on number of workers and fruit packinghouses  using
ethoxyquin fruit treatment are not available.  An estimate of apple
packing-houses in this country is between 500 to 1000.  The number  of
workers exposed to ethoxyquin per packinghouse varies with the treatment as
will be explained in the following treatment descriptions.


                                 28

-------
     Fruit Wrapping is principally done at some 40 packinghouses handling
'Anjou' pears.  An estimated 20 to 90 Sorter/Wrappers  (typically women)  per
house handle wrappers.  Wrapping continues 8 hr/day during a  1-2 month
harvest season.  Workers usually wear gloves, but these  are primarily to
protect the fruit from bruising, not as a protective device.   All  labels
contain the warnings, "Keep out of reach of children"  and "Wash hands
before eating".
     In ethoxyquin drench or dip operations only 2-3 workers  per
packinghouse engage in treatment of apples.  Typically these  operations
are performed outdoors and involve maneuvering truckloads or  bulk  bins
through drench showers or into dipping tanks.  Forklift  operators, machine
operators, and truck drivers are all potentially exposed to some spray and
liquid.  Most of these operations are at least partially automated.   For
example, bins and truckloads of fruit are dragged through drenches by
motorized chains operated by a worker at a control board.  Individual
apples in these methods are seldom handled until after storage when  they
are sorted and packed for shipment.  There are an estimated 500 to 1000
packinghouses using these methods.  Except for gloves  normally worn  by
fruit handlers, protective clothing is not usually worn.
     Spray, brush, or wax operations are usually located inside the
packinghouse but are separated by walls from most of the workers.  One or
two workers are potentially exposed to ethoxyquin in liquid or wax,  as they
oversee the operation of the belt line.  One of these workers  usually is
responsible for adding and mixing of fresh ethoxyquin  solution.  Sprays  are
stream-like rather than a fine mist.  After the fruit  is dried, it is
handled by sorter/packers.  These workers usually wear gloves  but no  other
protective clothing.  Wax treatment of the fruit may be  somewhat tacky at
this stage.  Approximately 40 to 80 packinghouses use  these treatment
methods.

B.  Manufacturing-Use Ethoxyquin

 1.  Environmental Fate Profile

          There are no data currently available on the environmental  fate of
     Ethoxyquin.

 2.  Exposure Profile

          Because of the scarcity of data on the environmental fate  of
     Ethoxyquin, it is impossible to quantitatively assess exposure  of
     humans and wildlife to manufacturing-use Ethoxyquin.

 3.  Data Requirements and Data Gaps

          Since the outdoor spray (preharvest) use of  ethoxyquin is
     reportedly discontinued, and in light of the low market  volume  and
                                 29

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     use patterns of ethoxyquift which indicate minimal exposure, environ-
     mental fate data requirements may be waived, if this use is dropped
     from the label.  (See Chapter 3).

C.  Formulations of Ethoxyquin

     General information relating to the emulsifiable concentrate  and
impregnated wrap ethoxyquin and specific label recommendations and
precautionary statements relating to their uses may be found  in Chapter
2 of this Standard.
 1.  Exposure Profile

     Emulsifiable concentrate (EC) formulations and impregnated  fruit
wrappings containing ethoxyquin are registered for control of a
physiological disorder called "scald" on apples and pears.  The  EC
formulations are applied by spray, dip, brush or flood techniques.
Application rates are recommended at 1.5 and 2.25 Ib. a.i./lOO gallons  of
water.  Since it is reported that preharvest sprays are apparently not  used
in current practice, all of the EC formulation is used for postharvest
treatment of fruit intended for storage.  Paper products impregnated with
between 0.04 and 0.131% ethoxyquin are registered for use as fruit wraps.

 All formulations:

     The potential exposure by inhalation of volatilized ethoxyquin cannot
be assessed due to the lack of vapor pressure and volatility data on either
the manufacturing-use product or formulations.  Hydrolysis data  which coxilrf
provide identification of possible pesticide related products formed in
application solutions are also lacking.  Since the use of ethoxyquin
formulations for preharvest foliar applications is reported not  to be a
current practice, the direct contamination of soil or natural water from
registered uses of ethoxyquin is unlikely.
     As with most pesticides, the greatest human exposure will probably be
to those workers engaged in mixing, loading, and treatment operations.
However, quantitative data are not available to estimate the degree of  such
exposure.  The principal regions of use of ethoxyquin are in the apple-
growing areas from Virginia north through New York State and Massachusetts
and the apple and pear producing regions of Washington and Oregon.  Treated
fruit which may bear residues of ethoxyquin are available to the
general population.
     Data on the metabolism of ethoxyquin indicate that it can selectively
alter aflatoxin conversion in Aspergillus parasiticus strains that
synthesize both B and G type toxins.  Large increases in the more potent B
type may be due to inhibition of the organism's conversion of aflatoxin B
to G.  Thus increases in aflatoxin residues on Aspergillus-contaminatcd
food crops treated with ethoxyquin appear to be possible.
                                 30

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     The potential for human exposure (inhalation and dermal) during
loading, mixing and application operations  is  recognized.   For  drench  and
dip operations, 2-3 workers are closely involved in the  treatment  of apples
in each of an estimated 500 to 1000 packinghouses using  these methods.
Operations are typically performed outdoors with forklift operators,
machine operators and truck drivers all potentially exposed  to  some spray
and liquid.  Individual apples are seldom handled until  after storage when
they are sorted and packed for shipment.  Except for gloves  normally worn
by fruit handlers, protective clothing is not  usually worn.  Spray, brush
or wax operations are usually performed inside  the packinghouse where one
or two workers are potentially exposed to ethoxyquin in  each of the
approximately 40 to 80 packinghouses which  use  these treatment methods.
These workers are usually responsible for adding and mixing  fresh
ethoxyquin solution. Fruit is handled by sorter/packers  who  usually
wear gloves but not other protective clothing.
     In summary, about 1000-3000 workers are involved in the application  of
ethoxyquin to fruit using EC formulations.  The presence  of  liquids and
sprays containing the active ingredient is  a potential source of dermal
and inhalation exposure to all of them.  An undetermined  number of
sorter/packers who usually wear gloves are  exposed to a  lesser degree.
Residues on fruit surfaces would be a source of slight dermal exposure to
humans during marketing and consumption.

 Impregnated material (Paper fruit wrap)

     Fruit wrapping is presently performed  in  some 40 packinghouses
handling "Anjou" pears.  An estimated 20 to 90 sorter/wrappers  (typically
women) per house handle the wrappers.  Wrapping continues 8 hr/day during
a 1-2 month harvest season.  Workers usually wear gloves  but not
other protective gear.  Residues of ethoxyquin  transferred  to fruit from
treated paper wraps may be a source of slight  dermal exposure during
marketing and consumption, but the dietary  contribution  is  extremely low.
                                 31

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                                    VI

                                TOXICOLOGY

A.  Manufacturing-Use Ethoxyquin

1.  Toxicology Profile

      The chronic no-observed effect level for ethoxyquin  is 0.0062Z.
 Acute oral data, although insufficient in detail, indicates low acute
 oral toxicity (LD50 in rats: 3150 mg/kg).

2.  Data Requirements and Data Gaps

      The toxicology data requirements and data gaps are listed in
 Chapter 3 of this Standard.
     Since no manufacturing-use Ethoxyquin is currently registered,  these
data requirements would automatically become data gaps in the event  an
application for registration was filed for a manufacturing-use chemical.

 Food Use (Requires a Tolerance or Exemption)

      All applicants for registration of technical products which are
formulated into end-use products intended for use on food must submit or
cite the following:
 Category of Test
     Description
Data Requirement
 Chronic Feeding
 (163.83-1)
A two year feeding study
in the rat.
    Satisfied
 Oncogenicity
 (163.83-2)
 Teratogenicity
 (163.83-3)

 Reproduction
 (163.83-4)
An oncogenicity study in each
of two suitable mammalian species,
Teratogenicity testing in two
mammalian species.

A two-generation reproduction
study, preferably in the rat.
    Satisfied


    Satisfied



    Satisfied
                                 32

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 Mutagenicity           A mammalian  in vitro point muta-
 (163.81-1              tion test; a sensitive sub-mam-
  through               malian point nutation test; a
 163.81-4)              primary DNA damage test; a mam-
                        malian in vitro cytogenetics test.   Satisfied

 Metabolism             A general metabolism study in one
 (163.85-1)             mammalian species.                   Satisfied

 Human and Domestic Animal Hazard Assessment

      Since no manufacturing-use Ethoxyquin products are currently
registered, potential acute, sub-acute or chronic effects in humans  and
animals cannot be assessed.

 Required Labeling

      Precautionary labeling of each product must correspond to  the  toxicity
categories determined by five acute toxicity tests.  Acceptable  cate-
gories pf acute toxicity and the corresponding required labeling appear
in the Chapter 2 of this Standard.

3.  Topical Discussions

      Corresponding to each of the Topical Discussions listed below  is the
number of the section(s) in the 'Proposed Guidelines' of August  22,  1978
(43 FR, No. 163 37336) which explain(s) the minimum data that the Agency
usually requires in order to adequately assess ethoxyquin's toxicology.
Where no section number is listed, a minimum requirement has not been set
for such information.
      The topical discussions describe available toxicity data on
 technical ethoxyquin and its formulations and state whether they are
 adequate for Agency regulatory purposes should application be made  for
 registration for a manufacturing use Ethoxyquin.

 Acute Oral Toxicity (163.81-1)

      The minimum testing needed on acute oral toxicity is one test, in the
 laboratory rat, on the technical chemical and on each manufacturing-use
 product.
      No adequate data were available for adequately assessing the acute
oral toxicity of technical Ethoxyquin; testing is required.  However, the
available data do indicate a low oral toxicity.  A Russian report which
has insufficient details gives oral LDSO's of 3150 mg/kg for rats and
3000 mg/kg for mice (Kellman, G.Y., 1965, MRID# 05000684).  The  acute
oral LD50 for chickens has been reported to be 8-10 gm/kg, suggesting a
low acute oral toxicity in chicks (Gassner, 1960; MRID# 05000517; and
Colorado Agricultural Research Foundation, 1951; MRID# 00001917).
                                 33

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 Acute Dermal Toxicity (163.81-2)

      The minimum testing needed on acute dermal toxicity  is one  test,  pre-
 ferably in the albino rabbit, on the technical chemical and on each manu-
 facturing-use product.

 No tests on technical ethoxyquin are available.

 Acute Inhalation Toxicity (163.31-3)

      The minimum data requirement for acute inhalation  toxicity  is  one
test, preferably in the albino rat, on the technical chemical  and on each
manufacturing-use product.  There was one study using  technical ethoxyquin
(Scientific Associates, 1960, MRID #00002202).  Seven males and eight
female rats were exposed 6 hours to 15.54 mg./liter  (ca. 1750ppm.),  then
observed for 14 days. Droplet size was 1 to 6.75 micron  (90-92% 2-4u).   Ho
ill effects were observed.  Necropsies revealed no macroscopic systemic
damage.  This study fulfills the data requirement.

 Primary Eye Irritation (163.81-4")

      The minimum testing needed to evaluate eye irritation potential  is one
 test, in albino rabbits, on each manufacturing use  product.   If  the test
 substance has a pH of 1-3 or 12-14, however, it will be judged corrosive,
 and an eye irritation test is not needed.  If the test  substance, has  been
 judged to be dermally corrosive, an eye irritation  test is not needed.

      No data were available for assessing the primary eye irritation  of
technical Ethoxyquin.

 Primary Dermal Irritation (163.81-5)

      The minimum testing needed to evaluate dermal  irritation potential is
one test, preferably on the albino rabbit, on each manufacturing  use
product.  No data were available for assessing primary dermal  irritation
of technical ethoxyquin.

 Skin Sensitization (163.81-6)

      The minimum requirement for assessing skin sensitization is an
interdermal test in one mammalian species, preferably the  guinea  pig,  on
each manufacturing-use product.  Skin sensitization  was  studied by the
method of Draize, Woodward and Calvery (MRID /'0500474).  Ethoxyquin was
mixed with an equal amount of Tween 80 and suspended in  saline for
injection.  No sensitization developed.  This is an  acceptable laboratory
sensitization test.  Nevertheless, note human experience discussed in
the supplementary information section at the end of  this Chapter.
                                 34

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   Subchronic Testing
   Subchronic Oral Toxicity (163.82-1)

        The minimum data requirement for Subchronic oral  toxicity  is  one  test
'  for the technical formulation in two mammalian species, preferably  using  the
  rat and dog.
        Twelve studies relating to the subacute oral toxicity of ethoxyquin
  were reviewed.  They are listed on the following table.
                   Subacute Oral Dosing Studies Reviewed
   Studies

      1.
      2.
      3.

      4.

      5.

      6.

      7-
      8.
      9.


      10.

      11.

      12.
  Authors
Species
  Fanner and Packer       rat
  Kellman               mouse & rat
  Parke, Rahim and        rat
   Walker
  Walker, Rahim and       rat
   Parke
  Parke, Rahim and        rat
   Walker
  Skaare, Nafstad and     rat
   Dahle
  Takahashi and Hirago    rat
  Gordon and Machlin      dog
  Whanger, Wesig,
   Oldfield, Cheeke and   lamb
   Schmitz
  Colorado A & M Univer-  chicken
   sity
  Poultry Producers of
   Central California     chicken
  Gassner, Buss, Hopwood
   and Thompson           chicken
MRID Number

 05000529
 0500068A
 05000411

 05000440

 05000450

 05001835

 05012507
 00001932

 05000420

 00001919


 00001920

 05000517
        Seven
  each tested
  assessed the
  studies met
  first study
  Elector H on
  3.0% of the
  H is capable
studies assessed the effects of ethoxyquin on rats; one study
the effects of ethoxyquin on dogs and lambs and three studies
 effects of ethoxyquin on chickens.  None of these reviewed
the standards of the subacute oral toxicity testing.  The
(Panner and Packer, MRID #05000529) examined the effect of
 hepatic alterations in both male and female rats fed 1.5 or
compounds for up to one month.  The study showed that Fleeter
 of causing gross as well as microscopic alterations in the
                                    35

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livers of rats.  Inadequate information about the preparation used  "as  one
of the drawbacks of this study.   Kellnan (MRI!) *050006"4) undertook
subacute toxicity study of Santoflex by the oral route of lower  dose  (l/^th
of the LDj.^ for one month in both rats and mice.
     No serious consequences were observed in the one month  feeding
studies using doses of l/5th the LncQ  ^e details of techniques were
sketchy.  Both nice and rats were used in this study, but strains,  sexes,
and numbers of animals used were not given.  In addition details pertain-
ing to how the compound was administered were not available.  The  third
study (Parke, Rahim and Walker, MRID #05000684> reported that all of  the
hepatic changes (e.g. hyperplasia, hypertrophy and increased enzyme
levels) induced by ethoxyquin were reversible once the ethoxyquin was
removed from the diet for weanling male Wistar rats which were fed  for  14
days on a diet containing 0.5% ethoxyquin.  The fourth study (Walker, Rahim
and Parke, MRID #05000440) reported that in rats receiving dietary  levels
of 0.5% ethoxyquin from weaning for a duration of 60 days, ethoxyquin
caused an increase in relative liver weight, in the amount of microsomal
protein, cytochrones P-450 and b5, and in the. activity of biphenyl-4-
hydroxylase.  The toxicity study and detail of experiments were  not
reported in this study.
     In the fifth study, Parke, Rahim and Walker (MRID #05000450)
showed ethoxyquin caused hypertrophy of the liver and induction
of hepatic mixed function oxidase system of weanling male Wistar rats fed
0.5% ethoxyquin for 14 days.  A biphasic recovery also was observed during
a 30 day recovery period.  The sixth study (Skaare, Nafstad  and  Dahle,
MRID #0500lo°>5) reported that ethoxyquin administered prior  to dimethylni-
trosamine increased hepatic, necrosis.  In this study, 5 to 7 week old male
albino rats were fed ethoxyquin (37.5 rag/kg) for 2 months prior  to  the
administration of dimethylnitrosamine, 30 mg/kg, i.p.  The seventh  study
Takahashi and Hirago (MRID ??05012507).  Male rats were fed approximately
3.15 moles/kg./day of purified Ethoxyquin for three weeks and the following
results were reported:  Hemmorhages in the epididymis or testis  and the
prothronbin index was significantly decreased.  The experiment appears  to
have been conducted in a valid fashion, although a number of details
needed for a thorough evaluation are missing.  Note that the dose used
was quite high compared to effect levels reported in other studies.
Gordon and Machlin, (MRID #00001932) fed dogs ethoxyquin in  an egg  yolk-milk
or meat diet for 7 or 4 days did not show accumulation of ethoxyquin  in
the liver.  The study failed to report the grade, of ethoxyquin used and
the sex of dogs used.  There was neither clinical testing nor necropsies
nor histopathology performed.
     The ninth study in this series (Whanger, Wesig, Oldfield, Cheeke
and Schmitz, MRID# 05000420) reported that 500 ng of ethoxyquin  three times
a week was well over the ^D,.- value for lambs.  Dosage cut back  to  250  mg
three times a week resulted in no reported mortality.  The tenth study
(Colorado A £ M University, MRID #00001919) examined the subacute toxicity
of Santoquin on the chicken.  Subacute feeding of Santoquin  at levels
ranging from 0.015 to 1.5% for 12 weeks had no effect on body weights,
feed consumption and livability.  Histologically, the liver, spleen,


                                 36

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kidney, thyroid and tastes were also normal.  The eleventh  report  (Poultry
Producers of Central California MRID #00001920) also  investigated  the
toxicological effects of ethoxyquin (0.0075, 0.075 and 0.15%  Santoflex  in
diet) on leghorn cockerels starting from one day old.  At the  end  of the
eight week period, there were no significant differences among the various
groups as to weight gain and feed consumption.  Further, no gross  patho-
logy of birds on eight week Santoflex treatment was noted.  The  last study
(Gassner, Buss, Hopwood and Thompson, MRID  #05000517) reported that there
were no significant effects on growth and feed consumption  of  chicken fed
different amounts of ethoxyquin (0.00075, 0.0015, 0.003, 0.0075  and
0.075%) in diet for 12 weeks.  Tissues of chicken showed neither gross  nor
inicropathologic changes.  Because of ethoxyquin's low toxicity as  indicated
by chronic oral toxicity data, and by years of experimental use  experience,
additional testing is not required.

Subchronic Dermal Toxicity (163.82-2)

     The minimum data requirement for subchronic 21-day dermal toxicity is
one study for the technical chemical, preferably using the  Albino  rabbit.
     One study (Wilson and DeEds, MRID #0500474) reviewed related
to subacute dermal toxicity testing.  In this study both rabbits and
guinea pigs were used for the study of skin irritation.  A  single  drop  of
the oily undiluted ethoxyquin was rubbed over an area of skin  2  cm. in
diameter, daily 5 days per week for 2 weeks.  This treatment  produced a
slight erythema followed by a papular eruption and occasional  scab forma-
tion.  The study also revealed that when treatment was stopped,  the
lesions disappeared, leaving a normal appearing skin  after  a  few weeks.
This study lacks details of techniques used, no sexes or number  of animals
were mentioned and no control animals were  compared.* The experiment did
not follow the requirement of 21-day (163.82-2) or 90-day (163.82-3)
periods.
     Subacute dermal toxicity data conducted using experimental
protocols acceptable by the guidelines are not available for  ethoxyquin.
The above study is only considered to be a  preliminary study.  However,
because of ethoxyquin's low toxicity as indicated by  acute  and chronic
oral testing in rats, further dermal testing is not required.
 Chronic Testing
 Chronic Feeding (163.83)

    A chronic feeding  study  is normally  required  for  all  food  uses  in  one
mammalian species (laboratory rat) using the  technical product.   The
study would normally be required  for  all food uses  of ethoxyquin.
     Data on a chronic feeding study  would be required for  the registra-
tion of each manufacturing-use product.  Testing  is usually required  in at
least one mammalian species  (the  species is normally  the  laboratory rat).


                                  37

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Equal numbers of males and females of each species and strain tested
must be used.  Dosing of rats begins as soon as possible after weaning and
in any case before the animals are 6 weeks old.
     Eight studies relating to chronic feeding testing of ethoxyquin
were reviewed.  Four of these studies met the species requirement of
the Agency's Guidelines.  Three studies which dealt with the chronic feed-
ing of ethoxyquin in dogs and chickens could be regarded as supportive
studies.  The other article was a review of some of the individual
studies.  They are summarized in the following table.
 Studies   Authors
Species
Duration
MRID Number
   1       U.S. Agricultural        rats
           Research Service,
           Western Utilization
           Research Branch

   2       Wilson and De Eds        rats

   3.      Fanner and Packer        rats

   4.      Rudra, Dickerson and
           Walker

   5.      Hanzal

   6.      Colorado A *< M Uni.

   7.      Gassner, Buss,
           Hopwood and Thompson     chicken

   8.      Pascal (review article)  rats &
                                    chicken
             715 days




             715 days

               2 years


  rats       500 days

  dogs     50-60 weeks

  chicken     70 weeks


              70 weeks

             715 days
                00001923
                05000474

                05000529


                05000419

                00001925

                00001919


                05000517

                05000412
     The first study (U.S. Agricultural Research Service, Western
Utilization Research Branch, MRID #00001923) reported that 5 to  10 rats of
both sexes were fed different dose levels (0,0.0062, 0.0125, 0.025, 0.05,
0.1 and 0.2%) of ethoxyquin for 715 days.  The study revealed that the
animals on all dose levels appeared comparable to control rats of the same
age.  Mortality was not extreme until after the 700th day when an infection
spread through the entire colony causing termination of the experiment.
The main histopathological findings were in the kidney at the 0.2% level
in females and 0.1-0.2% in male rats.  The lesions were not more severe
than those seen in comparable animals autopsied after shorter feeding
periods (200 or 430 days).  Proximal renal tube atrophy, renal tube
dilation, widening of collecting tubules, and patchy lymphocytic and
fibrous tissue infiltration were found.  The main drawback of this study
was the small number of animals used for the testing.
                                 38

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     Wilson and De Eds (MRID #05000474) examined the chronic  toxicity  of
ethoxyquin (0.0062-0.2% in the diet) in 270 weanling albino  rats  for up  to
715 days.  This study indicated that ethoxyquin incorporated  into  the  diet
exhibited a transient depression of growth rate of  rats.  Hemoglobin levels
remained normal.  There was no altered urinary excretion of hemoglobin or
protein.  Because of ethoxyquin metabolites, experimental urines were
darker, blackened with time.  The life span of animals was not altered.
At autopsy, there appeared shallow pitting of the renal cortex in  male
rats receiving the higher dose levels for 200 or more days.
Ambiguous increases in liver weights were observed  in females.  Increases
in kidney weights in females and liver and kidney weights in males were
observed.  Microscopic examination revealed no lesions in females, but
lesions in kidneys, livers, and thyroids of males.  The kidneys of males
showed irregular zones of fibrosis, tubular atrophy, focal tubular dila-
tion and lymphocytic infiltration characteristic of chronic pyeloneph-
ritis.  There was a dose response in the occurrence of these  lesions.
Groups of male hepatic cells showed rounded eosinophilic hyaline inclu-
sions of different sizes up to the diameter of the  cell nuclei.  The
thyroids of treated males showed decreases in stored colloid, with diffuse
increase in height of the follicular epithelium, indicating mild hyper-
plasia.  The no observable effect level (NOEL) was  found to be 0.0062%.
     Fanner and Packer, MRID #05000529) reported the test of  35 male
and 35 female rats which were maintained for 2 years on the following
diets:  control, 0.01% and 1.5% Flectol H.  Only 3 males and  5 females
given the 1.5% diet in the 2 year study survived to sacrifice.  The study
showed that ethoxyquin caused gross as well as microscopic alterations in
the livers of both male and female Wistar rats.  The specific signs were
liver enlargement, fatty infiltration, necrosis and atypical  biliary duct
hyperplasia.  These effects were most pronounced at a dietary level of
1.5%.  The study lacks in the number of animals, dose selection and many
points of the guidelines.  The Fourth study (Rudra, Dickerson and Walker,
MRID #05000419) reported the effect of ethoxyquin at 0.5% level on body
weight and kidney in weanling male Wistar rats for  500 days.  The  study
showed that ethoxyquin reduced weight increment and caused severe  kidney
damage.  This study is of limited value since many  areas of guidelines
e.g. duration of testing, number of dose levels, both sexes of rats,
observations of animals, etc. are lacking.  The fifth study (Hanzal, MRID
#00001925) reported that ethoxyquin produced substantial toxic effects in
the liver and kidney at dose rates of 10 to 100 mg/kg/day.  The associated
stress of histoplasmosis (in one dog) appeared to enhance similar  signs
of toxicity at the lower dose rate of 3 mg/kg/day.  These data provide a
fair basis for speculating that the minimum effective dose of Ethoxyquin
lies in a range below the 3-10 mg/kg/day oral dose  given over a period
of 50-60 weeks.  However, a no-observed-effect-level was not  found.
   The sixth study (Colorado A & M University, MRID #00001919) reported the
effects of ethoxyquin (0,0.00075 and 0.075%) on chickens.  No effect on
growth of the breeding flock was found during the 70 weeks study. , The
seventh study (Gassner, Buss, Hopwood and Thompson, MRID #05000517) also
reported the effect of feeding ethoxyquin on chickens.  In this study,
                                 39

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0.00075, 0.0075 and 0.075?' ethoxyquin were used in the feed for 70 weeks.
The results concluded that with graded levels up to 0.075% of ethoxyquin
in the diet showed no significant effects on mortality, growth, feed  con-
sumption, livability, egg production, fertility of eggs and hatchability
of eggs.  Tissues of chickens showed neither gross nor nicro-pathology
which could be ascribed to the treatment.  The study reviewed in  the
eighth article (Pascal, MRID #05000412) has been discussed in the pre-
vious studies (Wilson and De Eds, MRID #05000474 and Gassner, Pmss, Hop-
wood and Thompson, MRID #05000517).  The no observable effect level of
0.0062% found in the DeEds et. al. study for the rat is accepted, and
satisfies this data requirement.

Oncogenicity (163.83-2')

     Only one study (Wilson and De Eds, MRID #05000474) mentioned the
presence of tumors in a report on chronic toxicity of ethoxyquin
(0.0062-0.2% in the diet) in rats fed up to 715 days.  The study
stated that occasional tumors were present in the 700-day animals.
     The study does not indicate that ethoxyquin has oncogenic potential,
since tunors, particularly in this age group, are not unusual, and the
incidence of occurrence was without relationship to dose level.
Further testing is not required.
 Reproduction Testing
 Teratology (163.03-3)

     No individual reports of tests satisfying the teratogenic  guidelines
were found.  We do have information relating to teratogenic potential,
which includes reproductive studies in rats and the use  for many  years  of
ethoxyquin as an additive in animal feeds.
     Because rats tend to resorb rather  than abort imperfect  conccptus,
the resorption in rats fed ethoxyquin was studied  (Telford, I.R.  et   i\l_ ,
1962, MRID# 05000428).  A single dose of 0.25 grams (ca. 50 mg/kg.) was
given after positive mating.  Twenty days after positive mating,  pregnant
rats were killed and young delivered by caesarian section.  There were  no
greater percent of absorption for the treated group than for  the  control
group.  No gross malformations were reported.

     Ethoxyquin was fed to rabbits (Isenstein, R.S.,  1970, MRTD#  050003661
in amounts up to four times the amount used as a feed additive  (0.01%;  ca.
3 mg/kg/day).  Treatment started 10 days before breeding and  continued
until 2 weeks after parturition.  There were no abortions or  gross
deformities noted.

-------
     In addition, feed containing ethoxyquin added under FDA  regulation
has been fed to livestock for many years.  No  reports  of harmful  effects
of any kind from such feeding have been found.  Further testing for
teratogenicity is not required.

 Reproduction (163.83-4)

     The minimum data requirement for reproduction is  testing in  one  mammal-
ian species, preferably the laboratory rat, using the  technical formulation
and lasting for two generations.
     Nine studies relating to reproductive testing of  ethoxyquin  were
available for review.  Of the nine studies, one was a  review  article,
five were reports submitted to Monsanto, and three were articles  from the
original literature.  None of these studies met the requirements
individually for reproduction testing.
     MRID # 00001919 is a study of the reproductive effects of ethoxyquin
on chickens.  No effects on growth of the breeding flock were noted during
the study.  No effects could be attributed to  ethoxyquin treatment on any
of the parameters measured in this study (body weight, hatchability,  etc.).
MRID # 0001915 is a review article which considers work on the toxi-
city of ethoxyquin from 1951 to 1954.
     Another study (MRID #0001933) was carried out with albino Sprague-
Dawley rats.  Animals were fed diets slightly  deficient in vitamin E  in
which ethoxyquin was mixed to give the following dietary levels:  0,0.025
and 0.05%.  Animal treatment groups consisted  of from  8-19 animals each.
Feeding the experimental diet was begun at 60  days of  age and feeding of
the ethoxyquin-mixture was continuous.  Female rats were mated at 100 days
of age (FO).  After weaning, the females were  bred two more times.  In
addition, progeny from the first mating were placed on the ethoxyquin diet
for 100 days and mated at 100 days of age (Fl).  The number of litters and
average litter size was recorded for all matings.  The results indicated
that diets containing ethoxyquin did not interfere with reproduction  in
rats.  Instead, the ethoxyquin increased reproductive  efficiency.  This
increase may have resulted because the diets were marginal in Vitamin E.
     Initial treatment was at day 60 instead of day 40 and only two doses
(instead of three) were used.  This study does not meet the guideline
requirements for a reproductive study.
     A diet supplement study (MRID #00001934)  in which ethoxyquin was fed
to Sprague-Dawley rats from 60 days of age onward at a dietary level  of
0.1%.  Two matings were monitored.  The animals receiving the experimental
diets produced young and raised them successfully as did the  controls.  Off-
spring of animals receiving 0, 0.025 and 0.5%  ethoxyquin in their diets
were studied.  Insufficient details are given  to make  this a  meaningful
report.
     A study was carried out by the Wisconsin  Alumni Research Foundation
(MRID #0001924) with white albino Sprague-Dawley rats. Females believed to
be pregnant from 1-10 days were grouped into 4-9 animals each and placed on
test diets containing 125, 375 and 1125 ppm ethoxyquin.  The  number of
young produced, the number of live young born, the number of  animals  liv-
                                 41

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ing at 3 days, the number of animals weaned  and  the  weanling  weights were
recorded.  In a second  study young  adult  virgin  female  rats were mated and
placed into six experimental groups of 4-9 animals per  group.   The same
diet regime as in experiment 1 was  used.  In addition  to the  parameters
recorded in experiment  1, gestation time  also was recorded.   There
appeared to be a reduction  in the average number of  young per litter in
the ethoxyquin treated  group; however, it was not dose-related and in fact
the 125 and 325 ppm ethoxyquin-treated groups showed a  greater reduction
in litter size than did the higher dose level.   There was  a reduction in
the number of live animals  in experiment  2 at 1125 ppm  ethoxyquin but this
did not agree with the  comparable group in experiment  1.   Furthermore the
high doses in experiments 1 and 2 did not agree.  A  possible  explanation
may be related to the lack  of control mating and marking  of pregnancy in
the females in group 1.  The numbers of animals  that survived  to weanling
were not different in any of the groups with the exception of  the 1125 ppm
ethoxyquin treatment.   The  experimental protocol employed  in  this study
did not conform to established EPA guidelines.
     A study published  in the American Journal of Anatomy (110:29-36) (MRID
#05000428) dealt with fetal absorption in the rat as influenced by ethoxy-
quin.  The data presented suggested that  ethoxyquin  offered some bene-
ficial effects on the resorption rate; however,  alpha and  gamma tocop-
herol as well as other  antioxidants were  more effective.   In  this study
Walter Reed-Carworth Farm strain rats in  their first generation were used.
They weighed approximately  200 g at the time of  breeding.  After positive
mating, the females were randomly distributed into experimental and  con-
trol groups and the experimental groups were given Ethoxyquin  orally or
it was placed into their diets.  Twenty-two  days after  mating,  the females
were killed and the young delivered by Caesarian section.  A  careful micro-
scopic survey was made  for  resorption sites  and  resorptions were charted
as to location in the respective regions  of  the  horns and  classified as to
degree of resorption.   There were no adverse effects.   This is  not an
acceptable reproductive study as now required by EPA guidelines.
     A study published  in the American Journal of Vet.  Research (31:  907-
909) (MRID #05000366) involved feeding ethoxyquin at levels up to four times
normal to rabbits during pregnancy.  Male and female New  Zealand white
rabbits were used, age  unknown.  Not all  animals were virgins.   Some of
the animals used in the first experiment  were re-used in  the  second  experi-
ment.  The prior exposure of the animals  to  ethoxyquin  if  any,  was not
indicated.  Female rabbits  received experimental feed from at  least  10
days before breeding to at  least two weeks after parturition.   Male
rabbits received experimental feed for at least  10 days prior  to breed-
ing.  There were 11-20  rabbits per group.  There were no  absorptions or
physical defects noted.  In the first experiment there  were no  differences
in average litter size, gestation period  and percentage of mortality at or
following birth between experimental and  controls.   In  the second experi-
ment there was greater  neonatal mortalilty in the groups  which had not
received ethoxyquin.
                                 42

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         Finally a reproductive study which was  published  in  the  Journal of
    Agricultural and Food Chemistry  (7:203-206)  (MRID  #05000474)  deals with
    Sprague-Dawley rats which were on a diet  containing  0,  0.025,  0.05 and 0.1%
    ethoxyquin.  The animals were placed  on their  respective  diets when 60 days
    old and received the diets continuously thereafter.  The  rats  were mated
    when 100 days old, with four females  and  one male  to a  cage and rotation  of
    the males once a week.  After this mating, the  rats  receiving  0.1%
    ethoxyquin were discarded because this concentration seemed "unnecessarily
    high".  After all litters were weaned, the rats were re-mated  and  following
    weaning of these litters, a third mating  was initiated.   In addition to the
    above, offspring of animals receiving 0,  0.25 and  0.05?' ethoxyquin diets
    were saved from the first mating, continued  on  their respective diets and
    mated when 100 days old for a second  generation study.  There  were no
    effects that could be related to ethoxyquin  treatment.

    Although the available studies do not individually meet current
    guidelines for reproductive toxicity  testing, collectively they indicate
    no harm to reproductive ability  should be expected.

Mutagenicity

         The Agency's mutagenicity testing requirements  are being  revised.
    Only a single study relating to  the mutagenic potential of ethoxyquin
    was reviewed (Joner, P.E., 1977; MRID #05000385).  TA 1535, 1537,  1538,  98
    and 100 of Salmonella typhimuriuci were used.  The  tests were  performed  with
    and without the addition of a PCB-induced microsomal mixed function
    oxidase system (S-9) obtained from rat liver.   The test system utilizing
    the five strains of Salmonella , was  run  at  10, 100  and 1000 ug ethoxyquin
    per plate.  The compound was not mutagenic in the  tests.  One  hundred and
    1000 ug of ethoxyquin per plate  were  toxic especially  to  trains TA 1535 and
    TA 100.  Thus at high concentrations, ethoxyquin was toxic to  the  growth  of
    Salmonella but was not mutagenic.   In addition to the above  test  (Ames),
    other mutagenic testing may be required when guidelines have been
    revised.  No testing is requested at  this time.

Metabolism (163.85-1)

         The minimum data requirement for metabolism is  a single dose  using the
    analytical pure grade of the active ingredient  in  the radioactively labeled
    form.
        A study was conducted in the rat  and  cow (Wilson,  1959; MRID #05000475)
    using C   ethoxyquin.  Although  this  study does not  meet  data
    requirements for metabolism due  to improper  testing  methodology (animals
    were exposed to diets containing ethoxyquin  prior  to the  start of  the
    metabolism study and metabolite  investigation was  incomplete),  it  did show
    that ethoxyquin was excreted in  the urine and feces  (rats received a single
    1.5 mg dose; cows received a single 155 mg dose).  In addition, metabolites
                                     43

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found in the urine were water soluble (although individual metabolites
were not isolated) and there was some indication of transfer and excretion
in the milk of the cow.
    Another study (Monsanto, 19??; MRID #00001935) was conducted using  the
dog.  This study did show that labelled ethoxyquin was excreted in  the
urine (after collection for 24 hours) and 85% of the labeled ethoxyquin was
excreted as a metabolite, suspected to be sulfate or glucuronide conjugates
(the identification of the metabolites was incomplete).   In addition,
another dog was given labeled ethoxyquin and sacrificed at 4 hours.  The
liver and kidney were examined and labeled ethoxyquin was detected  in these
tissues.  Chromatography demonstrated that the primary metabolites  were
glucuronides and sulfates.
    Another study (TerMeulin and Walker, 1977; MRID #05002491) was
conducted using the laboratory rat.  Chromatography showed that metabolites
(not identified) were present in the bile within 12 hours after the
administration of labeled ethoxyquin.
    Skaare, J.U., and Nafstad , I. (1979, MRID #05012506) studied the
distribution of 5,7-(14C) Ethoxyquin in male rats.  Two rats were
sacrificed after oral intubation (104 mg./kg.-250u cu./kg.)at 0.5,  1, 2,  4,
8,  10,  12, 16, 20, 24, 48, and 144 hour intervals .  Whole-body
autoradiographs were made, and radioactivity in livers was measured.
Radioactivity peaked in the liver between the first and fourth day(2-3" of
dose).  After 6 days, 0.2% remained.  High radioactivity was reported to
have remained in the renal cortex after 6 days.
    No  attempt to identify the compounds retaining the radioactivity was
reported.
    The above data is not sufficient to satisfy the data requirement as set
forth in the guidelines for metabolism.  However the data do indicate
that ethoxyquin is metabolized to more polar compounds (conjugates  with
glucuronic acid or sulfate are the most likely metabolites) in the  dog.
Such metabolites have been identified in both tissue and urine in the dog.
In addition, the rat also metabolizes ethoxyquin to more polar compounds,
but the identification of the metabolites has not been made.
    Additional metabolism testing is not required at this time.

B. Toxicology - Emulsifiable Concentrate Ethoxyquin

1. Toxicology Profile

     The acute oral toxicity of 70% EC ethoxyquin is low based upon
research by Younger, 1960, (MRID #00001880).  Acute dermal toxicity is
described as very low, according to a report by Scientific Associates,
1960, (MRID # 00001884).    Acute inhalation testing showed no ill  effects
in rats (MRID #GS-0003-3).  Primary eye irritation is described as  mild by
Younger, 1960, (MRID #00001880).  Ethoxyquin is described as a mild primal
dermal  irritant by Younger, 1960, (MRID #00001880).  Tests on dermal
sensitization of ethoxyquin from manufacturing exposures indicate mild,  non-
persistant and unpredictable allergic dermatitis.


                                 44

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        Chapter 3 contains data tables for emulsifiable concentrate  showing
    which categories of test within the proposed guidelines are  required  for  EC
    ethoxyquin, along with the guideline citation, composition characteristic,
    use pattern, whether or not the Agency has sufficient data to  satisfy these
    requirements, and, if so, the bibliographic citation containing  this
    information.  The requirement for submission under FIFRA  3(c)2(B) and the
    amount of time allowed for submission is also listed in these  data charts.

    2. Topical Discussions

        For information concerning subchronic and chronic studies  using E.G.
    formulations refer to the Manufacturing-use Ethoxyquin section of this
    chapter, as data on the Manufacturing-use product may be  extrapolated
    to end-use formulations for these data categories.


   Topics

     Acute Oral Toxicity
     Acute Dermal Toxicity
     Acute Inhalation Toxicity
     Primary Eye Irritation
     Primary Dermal Irritation
     Skin Sensitization
     Subchronic Dermal (21-Day) Toxicity

    Acute Testing

    Acute Oral Toxicity (163.81-1)

        The minimum testing needed on acute oral toxicity is  one test in  the
    laboratory rat on each formulated E.G. product.

    The acute oral toxicity of 70% E.G. Ethoxyquin (6 Ib/gal.) in  the
laboratory rat is 3.3 g/kg (C.I. 3.0 - 3.6 g/kg) using Santoquin
(61b./gal.) (Younger, 1960; MRID #00001880). Toxic symptoms included
diarrhea, lethargy, weight loss and collapse.  No paralysis was noted.
Principal autopsy findings were inflammation of the gastric mucosa and
renal congestion upon microscopic examination.  This information is
sufficient to satify the data requirements for acute oral toxicity for the
EC ethoxyquin and assign labelling Toxicity Category III, which corresponds
to a low acute oral toxicity.

    Acute Dermal Toxicity (163.81-2)

        The acute dermal LD,0 in rabbits is greater than 8 g/kg using EC
    Santoquin (A.I. 70%) '(Younger 1960; MRID #00001884).  Toxic symptoms  were
                                     45

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lethargy and temporary loss of appetite.  This information satisfies  the
data requirement to assign labeling Category  IV; very  low acute  dermal
toxicity.

Acute Inhalation Toxlcity (163.81-3)

    A study using the emusifiable concentrate (Scientific Associates,  1960,
MRID #GS-0003-4) was reviewed.  Seven male and eight female rats were
exposed for 6 hours to 0.120 mg./liter (ca. 24pptn) solutions.  Droplet  size
was less than 1 to 7 microns(90-95%-1.75-3.5u).  All rats survived  the
dosing and were observed for 14 days.  There were no signs of  ill effect.
Although the study had only one dose level, it is acceptable for current use
patterns.

Primary Eye Irritation (163.81-4)

    A primary eye irritation study was conducted on rabbits (Younger  1960;
MRID #00001884).  In the study 100 mg of EC Santoquin  (A.I. 70%) was
applied to the rabbit eye resulting in mild eye irritation.
    The above information is sufficient to satisfy the data requirement for
primary eye irritation and assign labeling Toxicity Category III,
corresponding to a mild eye irritation potential.

Primary Dermal Irritation (163.81-5)

    A primary dermal irritation study was conducted on rabbits (Younger
1960; MRID #00001884).  In the study an unspecified amount of EC Santoquin
(A.I. 70%) was applied to rabbit skin resulting in mild dermal irritation
at 24 hours and no irritation at 72 hours.
    The above study is not sufficient to satisfy the data requirement for
primary dermal irritation due to lack of reporting of  the amount of
substance applied.  However, the data suggests that EC Santoquin (A.I.  70%)
is a mild skin irritant.  Additional testing is not required.

Dermal Sensitization (163.81-6)

    The minimum data requirement for dermal Sensitization is an  intradermal
test for the manufacturing-use product and each registered product,
preferably using the guinea pig.
    No laboratory data were available for assessing dermal Sensitization of
EC Ethoxyquin, however epidemiological information from manufacturing
exposure indicated mild, non-persistent and unpredictable allergic
dermatitis.  Therefore, further testing is not required.
                                 46

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Subchronic Testing

Subchronic 21-Day Dermal Toxicity  063.02-2)

    The minimum requircnent to assess Subchronic  21-day  dermal  toxicity  is
one study, preferably in the albino rabbit, on  each E.C  formulation  of
ethoxyquin if any of its constituents is likely to increase skin absorpt
or to potentiate toxic and pharmacologic effects.  The Agency will evalu
need for this study on a case-by-case basis as  registrants apply for
registration under this Standard.  This data  requirement  is waived for
existing products based upon the Acute Dermal Toxicity Category to which
EC ethoxyquin is assigned  (Category IV '- very low acute  dermal  toxicity).


C. Toxicology - Impregnated Wraps

1. Toxicology Profile

     Fruit wrapping is performed in some 40 packinghouses handling
"Anjou" pears.  An estimated 20 to 90 sorter/wrappers (typically
women) per house handle the wrappers.  Wrapping continues o hr./day  during
an 1-2 month harvest season.  Workers usually wear gloves but not other
protective gear.  Residues of ethoxyquin transferred to  fruit from treated
paper wraps may be a source of slight dermal exposure during marketing and
consumption.  If registrants can demonstrate  that the material used  to
impregnate wraps is substantially similar to the  technical or manufacturing-
use formulations, the toxicology data requirements for the impregnated
wraps will be waived.
D. Supplementary Information

    These topics are provided as supplementary  information  in  conjunction
with the topical discussions, particularily in  the area of  Dermal
Sensitization.

Topic 1; Induction of Mixed Function Oxidase Enzymes  OTFO)

    Four studies were reviewed for the effect of either single or repeated
administration of ethoxyguin on induction of mixed function oxidase
system.  Three of these studies (Walker, 1973;  MRID #0500440;  Kah] and
Hotter, 1977; MRID 1*05000670; Netter,  1970; MRID #05001765) examined  the
effect of ethoxyquin on hepatic mixed  function  oxidase activity  in the
laboratory rat.  Principal findings are  that ethoxyquin administered  either
as a single dose or in the diet for up to 14 days cavises  induction of
cytochrome P-450 enzyme systems.  Ethoxyquin is a phenobarbital  type
inducer of cytochrome P-450.
                                 47

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     The fourth study in this series (Parke,  1974; MRID# 05000449) examined
 the possibility that ethoxyquin inhibits mixed function oxidase enzymes.
 These investigators using either a single administration of ethoxyquin or
 repeated dietary exposure to ethoxyquin demonstrate that ethoxyquin
 interferes with certain mixed function oxidase enzymes when administered
 continuously in the diet.
     The above information indicates that ethoxyquin is capable of
 modulating hepatic mixed function oxidase enzymes.  'In addition, there is
 preliminary evidence that suggests prolongation of  the life-span of  "aging"
 rats upon exposure to small levels of dietary ethoxyquin and continuous
 administration results in enhancement of drug metabolizing enzymes in  the
 liver.

 Topic 2; Potentiation

     One study (Skaare, 1977; MRID#05001835) was reviewed.  This study
 examined the potentiation of dimethylnitrosamine toxicity after
 administration of ethoxyquin in the laboratory rat.  Principal findings
 indicate that prior exposure to ethoxyquin either in the diet (500 ppm) or
 as a very high acute dose (500 mg/kg, p.o.)  increases hepatic necrosis and
 accompanying sequelae due to subsequently administered dimethylnitrosamine.

  Topic 3; Human Epidemiology (Dermal Toxicity)

     There ^re no requirements in the federal pesticide guidelines for
 human epidemiological studies.  Nonetheless, there are several reports in
 the literature of various dermatological disorders probably related  to
 exposure to ethoxyquin.  These human exposures and reactions have been
 reported superficially, but should be noted.  There are 10 reports of
 human exposures to ethoxyquin in the workplace  (mostly animal feeds)
 which have resulted in skin disorders.  They are:

Authors                                             File No.

Mehlhorn and Beetz                                 05000401
Koziak and Sesevicak                               05000394
Schubert et_ al.                                    05000543
Zachariae                                          05000444
Burroughs                                          05000669
Jung                                               05000386
Garasek and Kolensky                               05000384
Scott and Dawson                                   05000421
Kelly                                             GS-0003-3
Fisher                                             05000618

     All of these "studies" are essentially clinical reports of individuals
 who developed dermatitis while working in a  situation that would expose
 them to ethoxyquin and perhaps other compounds.  In some cases skin  testing
 (patch test) was done to document the allergic response (contact


                                  48

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dermatitis) to ethoxyquin.  In one study  (File No.  421)  ethoxyquin  was  used
as a "positive control" in a photo patch  test study.   All  of  the  ethoxyquin
responses were negative, except for these photo patch  tests.
    In summary, these reports constitute  a  sizeable body of evidence  which
suggests that ethoxyquin can be responsible for a dermatitis.   Transfer
of a worker to a site free from ethoxyquin  "cured"  some  of these  difficul-
ties.
        All of the data presented above represent an augmentation to  other
studies and supply additional data which may be valuable in the future.
Evidence of human dermal reactions (probably allergic) should be  noted.
                                 49

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                                VII

                          RESIDUE CHEMISTRY


A. Residue Chemistry - Manufacturing-Use Ethoxyquin

1. Residue Chemistry Profile

    Ethoxyquin is used to prevent scald in apples and  pears  during
storage.  As an anti-oxidant it is also a food additive  in animal-feeds  (21
CFR 573.380), and in certain dehydrated forage crops (21  CFR 573.00),  but
these uses are not being considered in this standard.
    Ethoxyquin formulations are applied to apples and  pears  by  spray pre-
harvest or as a dipping solution, post-harvest.  Ethoxyquin  is  also
impregnated on paper wrappings to prevent scald, post-harvest.
    Residues found in pears and apples are principally Ethoxyquin.   There
are no data on the degradation of Ethoxyquin in treated  apples  and pears.
In feeds fortified with ethoxyquin, degradation products  have been
reported but not identified.
     International (Codex) tolerances of 3 ppra have been  recommended for
residues of ethoxyquin in or on apples and pears.  The United States has
indicated its acceptance of these Maximum Residue Limits  (MRL), which
are the same as the U.S. tolerances.
     Whenever a pesticide is used on apples the Agency normally requires
data on whether residues in apple pomace, a feed item, are transferred
to meat, milk, poultry, and eggs; however, the Agency  is  not  requiring
such data to support the use of ethoxyquin on apples.
     Ethoxyquin is used (up to 150 ppm) in animal feeds  (21  CFR 573.230)
and dehydrated forages (21 CFR 574.400).  Tolerances for  residues in eggs,
meat, milk and meat by products have been established  to  provide for such
feed additive uses (21 CFR 172.140).  Assuming that the  3 ppm tolerance
in whole apples is not exceeded, the feeding of apple  waste will not result
in over-tolerance residues in milk, eggs, meat, and meat  by-products.
     In addition, apples treated with ethoxyquin are likely destined for
the fresh market, and little or no production of pomace  is expected.
    In studies with chickens using Ethoxyquin-2,4-  C, 97% of the
radioactivity is recovered in fecal material.  Degradation products  in
feces, with similar R- values as Ethoxyquin, were concluded  to  be
conjugates of Ethoxyquin.
    The regulatory method for ethoxyquin in/on apples  and pears
(PAM, Volume II) is a fluorometric method, modified from  the original
method of Bickoff, et_ al., (Anal. Chem. 28, 376 (1956),  and  is
adequate for enforcement purposes, assuming that Ethoxyquin  per se
is the predominant residue.  Residues in apples dipped in 3000  ppm
Ethoxyquin averaged 2.90 ppm.  The pre-harvest spray at  3000 ppm of
Ethoxyquin resulted in no residues (method sensitivity not reported).


                                 50

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    Residues in pears dipped in 3000 ppm of Ethoxyquin showed  0.03  ppm 53
days after application.
    Ethoxyquin residues were found in milk of cows  fed 150 ppm Ethoxyquin
for 13 consecutive days.  Ethoxyquin residues were  found  in calf, pig,  and
lamb livers fed as little as 30 ppm Ethoxyquin  for  10 days.  The  residues
consist mainly of Ethoxyquin, with less than 3% comprising the  degradation
products and possible conjugates of Ethoxyquin.

2. Data Gaps (See Chapter 3)

    The following data are required to support a registration  standard  for
Ethoxyquin:

(1)  Data on the degradation of ethoxyquin in or on apples and  pears
     subjected to typical commercial storage conditions are required.
     No data are available.

     If the required data identify degradation  products considered
     toxicologically significant, analytical methods for  their  deter-
     mination will be required.

(2)  Additional residue data on the level of residues in  or on  ethoxyquin
     treated apples and pears are required.  Only a fraction of the
     available data reflect maximum allowable application rates.

3.  Topical Discussions

 Use Patterns and Restrictions

    Ethoxyquin is formulated as an emulsifiable concentrate (EC)  containing
from 52.22 to 702 of the active ingredient.  Formulations containing the
active ingredient Ethoxyquin, may be used as a  spray pre-harvest  on apples
and pears or as a dipping solution, post-harvest, with concentrations of
active ingredient Ethoxyquin, varying from 1.5 lb-2.25 lb/100  gals, water.
    The active ingredient is also used to impregnate fruit wrapping paper
at concentrations of 0.04% to 0.131%.

Use restrictions specify that:

(a)  Applications to specific varieties of apples and pears specified
     on the labels are intended to prevent fruit injury to susceptible
     species •

(b)  Spray treatment application should be made only when the  daily maximum
     temperature remains below 85°F, with one application within  two days
     before harvest.

(c)  fruit wrapped with impregnated material should not have been
     previously treated with Ethoxyquin.


                                 51

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    Ethoxyquin is Co be kept out of drinking water or water used  for
domestic purposes, and not applied directly to lakes, streams, and ponds.

1. Metabolism in Plants

     The data on metabolism and breakdown of Ethoxyquin  is United.   No
metabolites have been reported.      ^
     Alfalfa meal was fortified with   C-Ethoxyquin  and  stored at roon
temperature for nine days.  The meal was extracted with  ether, and the
extract analyzed by radiochromatographic and fluorometric methods.
     Two oxidation products of Ethoxyquin were detected  but wore  not
otherwise identified (MRID #06001905).
     A comparison IR and UV spectra of "aged" Ethoxyquin, extracted  from
feeds with "freshly distilled Ethoxyquin" indicated  that there were no
major degradative changes.  The degradative products were not identified
(MRID #00001906).
    The limited amount of information presented gives no indication of
identity of "reaction products" remaining following  "aging" of Ethoxyquin.
There are no radiotracer studies of plant metabolism with respect to  uptake
and translocation of Ethoxyquin.
     We conclude  that netabolisn of Ethoxyquin in plants is not adequately
defined.

2. Analytical Methods

    Until clarification of metabolic pathways and/or degradation  of
Ethoxyquin residues in plants nnd animals has been presented, Ethoxyquin
remains the residue of concern.
     The regulatory method for ethoxyquin per se in  PAM  Volume II
and the method used to obtain data on residues of ethoxyquin in apples
and pears is a fluorometric method based on that of  Bickoff et_ al
(Anal. Chen. 23,  376 (1956), MRID// 00001809).
3.  Residues  in Apples and Pears

     The data of MRID #00001877  is  pertinent  to  the  registration  standard
of  Ethoxyquin but is an estimate and cannot be verified.
     Five varieties of apples and one variety of  pears  were  treated  as
follows with up to 3000 ppm of Ethoxyquin.  Apples were sprayed 0-7  days
before harvest, sprayed 0-1 day  post harvest, or  dipped for  15 seconds  into
a solution of Ethoxyquin.  Pears were sprayed 5-7 days  before harvest.
Formulation used was Stop-Scald-EC  with 70% Ethoxyquin.   Pre-harvest
treated apples and pears were analyzed 19-27  days after treatment, post-
harvest apples were analyzed 20-23  days after treatment;  and dipped  apples
4 days after treatment.  Storage conditions for  apples  are unknown.
Maximum residues resulted in apples dipped  in 3000 ppm  Ethoxyquin,  in which
peels averaged 2.75 ppm; in the  fruit 0.15  ppm.   All  other samples had
                                  52

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corresponding residues.  The  pre-harvest  spray (3000 ppm of
Ethoxyquin)resulted  in no  residues  (method  sensitivity not reported).  The
possibility of volatilization or  degradation  to  non-fluorescent  products is
suggested  (MRID  #00001889).
     Pears were  treated with  Ethoxyquin either by pre-harvest spray or post-
harvest dip.  They were analyzed  by the fluorometric method  (MRID
#00001889), 25 to 63 days  after treatment.  Formulation used was Stop
Scald-EC with 70% active ingredient.   The pears  were treated with up to
2000 ppm of Ethoxyquin.  Following  post-harvest  dip, the pears were
analyzed 53 days later, with  maximum residues  of 0.03 ppm in whole fruit
including peel.  Following  spray, samples analyzed 25-27 days after
treatment had maximum residues of 0.04 ppm; no residues were detected 61-63
days after treatment.  Data for blank samples  or sensitivity of  method were
not given.  No information was given as to  storage or storage stability of
Ethoxyquin (MRID #00001890).
     Hartman and Crownoil  paper wraps were  impregnated with  from 1 rag to
2.5 mg of Ethoxyquin.  Anjou  pears  were wrapped  with the impregnated paper
and stored for 8 months.   Analysis  showed that the Hartman wrap  left no
Ethoxyquin residue on pears.  Crownoil wraps  left  an average of  1.5 ppm on
pears.  Data for blanks samples and sensitivity  of method not given (MRID
#00002198).  The data requirements  are not  satisfied by this study.

B. Residue Chemistry - Formulated Ethoxyquin

1. Registration Requirements

    For future registration of a  pesticide  product for use on a  food or
feed crop not covered by this Standard, the Agency must  be provided with
data on metabolism of the  pesticide in plants, and when appropriate,  in
animals; a validated method for analysis of pesticide  residues in  or on raw
agricultural commodities,  and residue data  reflecting  the proposed use of
the pesticide on the crop.

2. Required Labeling - Emulsifiable Concentrate

    Labels on Emulsifiable Concentrate Ethoxyquin  used for direct
application to fruit must  contain a restriction  against the  use  of
impregnated wraps at a later  date.

Impregnated Wraps

    Wraps impregnated with Ethoxyquin intended for use on apples and pears
must bear a label restriction against  application  to fruit which has been
pre- or post-harvest dipped or sprayed with liquid formulations.
                                  53

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                                    VIII

                             ECOLOGICAL EFFECTS
A. Ecological Effects Profile

    Although no data are available on ethoxyquin toxicity to non-target
organisms, an assessment of potential hazard can be made by examining
information on use patterns.  The use pattern profile indicates  that
ethoxyquin is used as a post-harvest dip or spray on apples and  pears,
and as a fruit wrap for use on apples and pears.
    The use of wraps appears to present mimimal exposure to aquatic or
terrestrial habitat, therefore, wraps should not present an adverse
impact.  The other uses, as well as the treatment of wraps, may  expose non-
targets either directly from application or through dissipation  from
treatment sites.  Due to the absence of data on Ethoxyquin, a hazard
assessment on these uses cannot be made at this time.
    The preharvest spray use is reportedly no longer practiced in  the
orchard industry, but this use still appears on the label.  If this use
is dropped from the label, the major route of exposure to non-target
organisms will be substantially reduced.
    Based upon the status of ethoxyquin as a minor use pesticide (see
Chapter 2) and the elimination of this major route of non-target exposure,
the data requirements for Ecological Effects may be waived.
                                 54

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                       Guide to Use of This Bibliography


1.  Content of Bibliography.  Ihis bibliography contains citations of all
    the studies reviewed by EPA in arriving at the positions and conclusions
    stated elsewhere in this standard.  Ihe bibliography is divided into 3
    sections: (1) citations that contributed information useful to the re-
    view of the chemical and considered to be part of the data base supporting
    registrations under the standard; (2) citations examined and judged to be
    inappropriate for use in developing the standard; and (3) standard
    reference material.  Primary sources for studies in this bibliography have
    been the body of data submitted to EPA and its predecessor agencies in
    support of past regulatory decisions, and the published technical
    literature.

2.  Units of Entry.  Ihe unit of entry in this bibliography is called a
    "study".  In the case of published materials, this corresponds closely to
    an article.  In the case of unpublished materials submitted to the Agency,
    the Agency has sought to identify documents at a level parallel to a
    published article from within the typically larger volunts in which they
    were submitted.  Ihe resulting "studies" generally have a distinct title
    (or at least a single subject), can stand alone for purposes of review, and
    can be described with a conventional bibliographic citation.  Ihe Agency
    has attempted also to unite basic documents and commentaries upon them,
    treating then as a single study.

3.  Identification of Entries.  Ihe entries in this bibliography are sorted
    by author, date of the document, and title.  Each entry bears, to the left
    of the citation proper, an eight-digit numeric identifier.  Ihis number is
    unique to the citations, and should be used at any time specific reference
    is required.  'Ihis number is called the "Master Record Identifier", or
    "MRID".  It is not related to the six-digit "Accession Number" which has
    been used to identify volunes of submitted data; see paragraph 4(d)(4)
    below for a further explanation.  In a few cases, entries added to the
    bibliography late in the review may be preceded by a nine-character
    temporary identifier.  Ihis is also to be used whenever a specific
    reference is needed.

4. Form of the Entry.  In addition to the Master Record Identifier (MRID),
   each entry consists of a bibliographic citation containing standard elements
   followed, in the case of materials submitted to EPA, by a description of
   the earliest known submission.  Ihe bibliographic conventions used reflect
   the standards of the /merican National Standards Institute (ANSI), expanded
   to provide for certain special needs.  Some explanatory notes of specific
   elements follow;

   a*    Author.  Whenever the Agency could confidently identify one, the
         Agency has chosen to show a personal author.  When no individual was
         identified, the Agency has shown an identifiable laboratory or
         testing facility as author.  As a last resort, the Agency has shown
         the first known submitter as author.
                                     55

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b.    Document Date.  Vvhen the date appears as four digits with no
      question marks, the Agency took it directly from the docunent.  Vvhen a
      four-digit date is followed by a question mark, the bibliographer
      deduced the date from evidence in the docunent.  When the date appears
      as (19??), the Agency was unable to determine or estimate the date of
      the docunent.

c.    Title,  ihis is the third element in the citation.  In some cases
      it has been necessary for Agency bibliographers to create or enhance a
      docunent title.  Any such editorial insertions are contained between
      square brackets.

d.    Trailing Parentheses.  For studies submitted to us in the past,
      the trailing parentheses include (in addition to any self-explanatory
      text) the following elements describing the earliest known submission:

      (1)  Submission Date.  Immediately following the word 'received'
           appears the date of the earliest known submission.

      (2)  Administrative Number.  Ihe next element, immediately
           following the word 'under1, is the registration number,
           experimental permit nunber, petition nunber, or other
           administrative number associated with the earliest known
           submission.

      (3)  Submitter.  'Ihe third element is the submitter, following the
           the phrase 'submitted by'.  Vvhen authorship is defaulted to the
           submitter, this element is omitted.

      (4)  Volume Identification.  Ihe final element in the trailing
           parenthesis identifies the EPA accession number of the volune in
           which the original submission of the study appears.  Ihe six-
           digit accession number follows the symbol 'CDL', standing for
           "Company Data Library".  This accession nunber is in turn
           followed by an alphabetic suffix wihich shows the relative
           position of the study within the volune.  Ebr example, within
           accession number 123456, the first study would be 123456-A; the
           second, 123456-B; the 26th, 123456-Z; and the 27th, 123456-AA.
                                  56

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                                     Sectton I

                              OFFICE OF PESTICIDE PROGRAMS
                          REGISTRATION STANDARD BIBLIOGRAPHY
                  Citations Considered to be part of the Data Base
                   Supporting Registrations Under the Standard
   MRID     CITATION

005000423   American Journal of Anatomy 110; 29-36.

005000368   American Journal of Veterinary Research 31; 907-909.

005000461   Bickoff, E.M.; Guggolz, J.; Livingston, A.L.; Thompson, C.R.(1956)
               Determination of 6-ethoxy-l,2-dihydro-2,2,4-triiriethylquinoline
               in biological materials.  Analytical Chemistry 28(3):376-37H.

005000669   Burroughs, D.; (1975) Contact dermatitis in animal feed mill
               workers.  British Journal of Dermatology 92:167-170.

000001917   Colorado Agriculture Research Foundation (1951) Project Progress
               Report: Investigations  on the Toxicity of Carotene Stabilizing
               Agents.  ( Unpublished  study received Oct. 13, 1958 under PP0315
               prepared in cooperation with Colorado Agriculture Experiment
               Station, Poultry and Chemistry Sections, submitted by Monsanto
               Chemical Co., St. Louis, Mo.,: CDL:095541-9-S).

000001919   Colorado A&M University (1953?) Project 144: Experiment II and III
               Chronic Toxicity of the antioxidant 6-ethoxy-2,2,4-trimethyl-
               1,2-dihydroquinoline (Santoquin, Monsanto).  (Unpublished
               study received Oct. 13, 1958 under PPO 315; prepared by
               Agricultural Experiment Station, Poultry and Endocrine Sections,
               submitted by Monsanto Co., St. Louis, Mo.; CDL:095541-9-U).

005000368   Cielens, E.; Stroza, I.; Utno, L.; Vevere, L. (1974) Vliyanie
               alpha-Tokoferola i antioksidantov na aliraentarnyi stress u
               tsypliat.  [Effect of alpha-tocopherol and antioxidants on
               alimentary stress in chickens.]  Latvijas PSR Zinatnu
               Akadenijas Vestis.  [Proceedings of the Academy of Sciences of
               the Latvian SSR.] (11):54-60.

005000474    Draize, Woodward and Calvery—See Wilson, R.H., DeEds, F. (1959)
               below.

005000497   Dunkley, W.L.; Franke, A.A.; Low, E. (1968) Compounds in milk
               accompanying feeding of ethoxyquin.  Journal of Dairy Science
               51(3):1215-1218.

005012189   Ernst, G.F.; Verveld-Roeder, S.Y. (1979) High-perfornance liquid
               chromatographic analysis of ethoxyquin in apples.  Journal of
               Chroraatography 174(1):269-271.

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005000613    Fisher, A.A. (1975) Allergic dermatitis in animal feed handlers.
               CUTIS 16(2):201-202.

005000674    Fuiiwara,  K.; Watanuki, S.; Arai, H., inventors; Seiko Chemical
               Co., assignee (1973) [Production method for
               6-ethoxy-2,2,4-trimethyl-l,2-dihydroquinoline.]  Japanese kokai
               73 49774.  Jul 13.  2 p.

005000517   Cassner, F.X.; Buss, E.G.; Hopwood, M.L.; Thompson, C.R. (1960)
               Effect of Feeding 1,2-dihydro-6-ethoxy-2,2,4-triraethylquinoline
               to chickens.  Poultry Science 39: 524-533.

00001932    Gordon, R.S.; Machlin, L.J. (1952?)  Determination of Minimum
               Dietary Level of Santoquin which produces no more than 0.1 ppra
               residue  in dog and monkey liver: Ratio to Greatest Possible
               Human Consumption of Santoquin and Calculation of Safety
               Factors.  (Unpublished study received Oct. 13., 1953 under
               PP0315;  submitted by Monsanto Co., St. Louis, Mo.; CDL:095541-9-
               AJ).

000002198   Hadley, K.G. (19??) Summary of Tests on Residues from Ethoxyquin
               Treated  Pear Wrap.  (Unpublished study received Aug 2, 1965 un-
               der 3222-6; submitted by Crown Zellerbach Corp., San Francisco,
               Calif.;  CDL:01074{5-2-E)

000001920   Halloran, H.R. (1952) Chick Toxicity Test on Santoflex AW: Project
               No. 2-52.  (Unpublished study including letter dated Jul 10,
               1952 from W.H. Armstrong to H.R. Halloran and letter dated Sep
               10, 1952 from A.A. Klose to 0. Ray Thompson, received Oct 13,
               1958 under PP0315; prepared by Poultry Producers of Central Cal-
               ifornia, submitted by Monsanto Co., St. Louis, Mo.;  CDL:
               095541-9-V)

000001925   Hanzal, R.F. (1955) Final Report:  Chronic Oral Administration
               in Dogs: Metabolic Studies.  (Unpublished study received Oct. 13,
               1953 under PP0315; prepared by Hazeltol Laboratories, submitted
               by Monsanto Co., St. Louis, Mo.; CDL095541-9-AC).

05000366    Isenstein,  R.S. (1970) Ethoxyquin in rabbit feed: study of
               relationship to abortion and early neonatal death.  American
               Journal  of Veterinary Research 31(5): 907-909.

00500385    Joner, P.E. (1977) Butylhydroxylanisol (BHA), butylhydroxytoluene
               (BHT) and ethoxyquln (EMQ) tested for mutagenicity.   Acta
               Veterinaria Scandinavica 18(2):187-93.

05000474    Journal of  Food and Agricultural Chemistry-See Wilson,  R.H., DeEds,
              F., (1959) below.

005000336   Jung, H.D.  (1975) Berufsdermatosen in der Landwirtschaft des Agrar-
               Industriebetriebezirkes Neubrandenburg.  Professional dermatoses
               in agriculture of the agricultural and industrial district of
               Neubrandenburg, East Germany.  Deutsch Gesundheitswesen 30(33):
               1540-1543.

-------
005000670   Kahl, R.; Netter, K.J. (1977) Ethoxyquin as an inducer and
               inhibitor of phenobarbital-type cytochrome P-450 in rat  liver
               microsomes.  Toxicology and Applied Pharmacology 40(3):473-483.

005000684   Kellman, G.Y. (1965) Comparative Toxicity of Santoflex AW and
               acetoaniline.  Kauchuk i Rezina.  Crude and Vulcanized Rubber
               I:24(3):40-41.

GS-0003-3   Kelly, R.E. (1965)  Letter sent to Jack Early dated Oct.  19, 1965.
               (Relative to the dermatitis causing potential of Santoquin).
               (In unpublished submission received Oct. 25,  1965 under
               524-Q; submitted by Monsanto Co., St. Louis, Mo.; CDL:109275-A),

0500394     Koziak, B.; Sesevick, L. (1971)  Kontaktny ekzem po krmnvch
               zmesiach pre hydinu.  Eczema produced by contact with poultry
               feed mixtures.  Pracovni Lekarstvi.  Occupational medicine.
               23(7)240-244.

000001915   Maclay, W.D., corap. (1954) Toxicity Data in Support of the Use of
               0.015 Percent of 6-ethoxy-2,2,4-trimethyl-l,2-dihydroquinoline
               on Alfalfa Meal for Carotene Preservation.  Summary of studies
               095541-9-R through 095541-9-X.  (Unpublished study received Oct
               13, 1958 under PP0315; prepared by U.S. Agricultural Research
               Service, Western Utilization Research Branch, Field Crop
               Utilization Section, submitted by Monsanto Co., St. Louis, Mo.;
               CDL:095541-9-Q)

05000401    Melhorn, H.C.; Beetz, D.  (1971)  Das Antioxydans Aethothyquin als
               berufliches Ekzematogen beim einem Futtermitteldosierer.
               Antioxidant ethoxqyuin as an occupational eczematogenous agent
               in a fodder-dosage distribution.  Berufsdermatosen 19(2):84-91.

005000403   Monroy, H., inventor;  (1973) Nouvelles dihydro-1,2 quinoleines,
               precede et appareil pour leur preparation.  [Apparatus and
               method for manufacturing 1,2-dihydroquinollnes.1  French
               demande de Brevet d'Invention 2,183,194.  May 3.  20 p. Int.
               C1.-2  C 07D 33/12; B 01D 1/06//A 01N.

00000004X    Monsanto Co. (1975?) Product Specifications (Santoquin).
               Unpublished submission by the Pennwalt Corporation received
               July 3, 1975(?) under 4581-316.

000001839   Monsanto Company (19??) Ethoxyquin on Apples and Pears.  Undated
               method.  (Unpublished study received Feb 10, 1960 under PP0245;
               CDL:092522-2-D)

00001919    Monsanto Company-See Colorado A&M University (1953) above.

00001920    Monsanto Company-See Halloran, H. R., (1952) above.

000001926   Monsanto Company (19??) Lack of Residue in Pigs, Lambs, and Calves
               Eating Santoquin Treated Forages.  (Unpublished study received
               Oct 13, 1958 under PP0315; CDL:095541-9-AD)

-------
000001935
000001905
000001906
000001377
000001390
005001765
05000529
05000411
05000450
005000449
05000412
0000006X
05000419
Monsanto Company (19??) The Metabolism of Santoquin C-14 by the
   Dog.  (Unpublished study received Oct 13, 1958 under PP0315;
   CDL:095541-9-AM)

Monsanto Company (1954) Change of Santoquin with Time.  (Unpub-
   lished study received Oct 13, 1953 under PP0315; CBL:095541-9-G)

Monsanto Company (1957) Nature of the Oxidation Products of Santo-
   quin.  (Unpublished study received Oct 13, 1958 under PP0315;
   CDL:095541-9-H)

Monsanto Company (1958) Full Report of Investigations Made with
   Respect to the Safety of the Pesticide Chemical: [Santoquin].
   (Unpublished study received on unknown date under unknown
   admin, no.; CDL:120377-7-C)

Monsanto Company (1959) 1959 Ethoxyquin Residue in Anjou Pears.
   (Unpublished study received Nov 1, 1960 under PP0315; prepared
   in cooperation with [Oregon State College], Agricultural Experi-
   ment Station; CDL:090335-1-A)

Hetter, K. J. ; Kahl, R. ; Elcombe, C.R. (1978) Significance of
   induction phenomena.  Archives of Toxicology, Supplement
   (l):85-99.

Panner, J. ; Packer, J.T. (1961) Hepatic alterations in rats fed
   l,2-dihdro-2,2,4-triraethylquinoline (Flectol H).  Proceedings of
   the Society for Experimental Biology and Medicine.  106(1 ): 16-19.

Parke, D.V.; Rahim, A.; Walker, R. (1973) Reversibility of hepatic
   changes caused by Ethoxyquin.  Biochemical Society Transactions
Parke, D.V. Rahim, A.; Walker, R. (1974) Reversibility of hepatic
   changes caused by Ethoxyquin.  Biochemical Parmacology
   23(13):1371-1376.

Parke, D.V. ; Rahim, A.; Walker, R. (1974) Inhibition of rat
   hepatic microsomal enzymes by ethoxyquin.  Biochemical
   Pharmacology 23(24) :3385-3394.

Pascal, C. (1974) Physiological aan metabolic effects of
   antioxidant food additives.  World Review of Nutrition and
   Dietetics.  19:237-299.

Rexolin Chemicals, Halsingborg, Sweden, (1971?) Unpublished
   study that includes analytical methods for ethoxyquin.
   Received May 8, 1973(?) under 4581-316.  Submitted by
   Pennwalt Corporation, Philadelphia, Penna.

Rudra, D.N. ; Dickerson, J.W.T.; Walker, R. (1975) Long-term studies
   on some antioxidants in the rat.  Journal of the Science of Food
   and Agriculture 25(8): 1049-1050.

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05000543    Schubert, H.; Goering, H.D.; Cans, U.  (1973)  Untersuchungen  zur
               Sensibisierungsfaehigkeit von Aethozyquin  und  p-phenetidin.
               Dermatologische Monatsschrift.  159(3):791-796.

GS-0003-4   Scientific Associates (1960) Santoquin Concentrated Emulsion
               Inhalation Study.  (Unpubished study that  includes Tables
               1-2; received Feb. 10, 1960 under 524-117.  Submitted1 by
               Monsanto Chemical Co., St. Louis, Mo., CDL: 003957-G).

05000421    Scott, K.W.; Dawson, T.A.J. (1974) Photo-contact  dermatitis  arising
               from the presence of quindoxin in animal feeding stuffs.
               British Journal of Dermatology 90(5):543-546.
005001835   Skaare, J.U.; Mafstad, I.; Dahle, H.K. (1977) Enhanced
               hepatotoxicity of dimethylnitrosamine by pretreatment of rats
               with the antioxidant ethoxyquin.  Toxicology and Applied
               Pharmacology 42(1):19-31.

05012507    Takahashi, 0.; Hiraga, K. (1978) The relationship between hemnorage
               induced by butylated hydroxytoluene and its antioxidant
               properties or structural characteristics.  Toxicology and
               Applied Pharmacology 46(3):811-814.

005000428   Telford, I.R.; Woodruff, C.S.; Linford, R.H. (1962) Fetal
               resorption in the rat as influenced by certain antioxidants.
               American Journal of Anatomy 110:29-36.

00001923    U.S. Agricultural Research Service, Western Utilization Research
               Branch (1955) Supplementary Report: 6-ethoxy-2,2,4-trimethyl-l,2-
               dihydroquinoline.  (Unpublished study received Oct. 13, 1953
               under PP0315; submitted by Monsanto Co., St. Louis, Mo;
               CDL:092596-6-D)

05000440    Walker, R.; Rahim, A; Parke, D.V. (1973) The effects of
               antioxidants on enzyme induction in developing and aging rats.
               Proceedings of thte Royal Society of Medicine 66(8):730.

05000420    Whanger, P.D.; Wesig, P.H.; Olfield, J.E.; Cheeke, P.R.; Schmitz,
               J.A. (1976) Selenium and while muscle disease in lambs: effects
               of vitamin E and Ethoxyquin.  Nutrition Reports International
               13(2):159-173.

005000474   Wilson, R.H.; DeEds, F. (1959) Toxtcity studies on the
               antioxidant6-ethoxy-l,2-dihydro-2,2,4-trinethylquinoline.
               Journal of Agricultural and Food Chemistry 7(3):203-206.

005000475   Wilson, R.H.; Thomas, J.O.; Thompson, C.R.; Launer, H.F.; Kohler,
               G.O. (1959) Absorption, metabolism, and excretion of the
               antioxidant, 6-ethoxy-l,2-dihydro-2,2,4-trimethylquinollne.
               Journal of Agricultural and Food Chemistry 7(3):206-209.

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000001930
00001933
00001934
005000443
000001924
000001834
000001880
000013,34
05000444


005000445
Wilson, R.H., comp. (1956) Distribution and Excretion of Oral
   Santoquin-14C.  (Unpublished study received Oct 13, 1958 under
   PP0315; prepared by U.S. Agricultural Research Service, Western
   Utilization Research Branch, Pharmacology, Field Crops, and
   Analytical Physical Chemical and Physics Sections, submitted by
   Monsanto Co., St. Louis, Mo.; CDL:095541-9-AH)

Wilson, R.H. (1956) Final Report—Reproduction in Rats Receiving
   Santoquin.  (Unpublished study received Oct. 13, 1958 under
   PP0315; prepared by U.S. Agricultural Research Service,
   Western Utilization Research Branch, submitted by Monsanto
   Co., St. Louis, Mo.; CDL:095541-9-AL.

Wilson, R.H. (1956) Reproduction in Rats Receiving Santoquin.
  (An interim status report of the above citation MRID# 00001933)

Wlnell, B. (1976) Quantitative determination of ethoxyquin in
   apples by gas chromatography.  Analyst 101(1208):883-886.

Wisconsin Alumni Research Foundation (1956) Assay Report: [Rat Re-
   production Study]: W.A.R.F. No. 6040733.  (Unpublished study
   received Oct 13, 195"8 under PP0315; submitted by Monsanto Co.,
   St. Louis, Mo.; CDL:095541-9-AB)

Younger, F.M. (1960) Certificate of Analysis: Toxicological Inves-
   tigation of: Santoquin Concentrated Emulsion (70% Active): Mon-
   santo Project No. Y-59-61-B.  (Unpublished study including sum-<
   mary, received Feb 10, 1960 under 524-117; prepared by Younger
   Laboratories, submitted by Monsanto Co., St. Louis, Mo.; CDL:
   003957-8-E)

Younger, F.M. (1960) Certificate of Analysis: Toxicological Inves-
   tigation of: Stop Scald (Six Pounds per Gallon Santoquin}:
   Project No. Y-60-74.  (Unpublished study received Dec 12, 1960
   under 524-117; prepared by Younger Laboratories, submitted by
   Monsanto Co., St. Louis, Mo.; CDL:050124-7-A)

Younger, F.M. (1960) Certificate of Analysis: Toxicological Inves-
   tigation of: Santoquin Concentrated Emulsion (70% Active):
   Monsanto Project Not Y-59-61-B.  (Unpublished study received
   Dec. 12, 1960 under 524-117; prepared by Younger Laboratories,
   submitted by Monsanto Co., St. Louis, Mo.; CDL:003957-3-E).

Zachariae, H. (1978) Ethoxyquin dermatitis.  Contact Dermatitis
Zanoni, L.;  Angiuli, G. (1973) La contamlnazione da etossichina
   degli aliment! e delle acquei studi e ricerche analltiche.
   analyses.]  Bollettlno del Laboratori Chimlcl Provincial!.

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                                Section II

                      OFFICE OF PESTICIDE PROGRAMS
                   REGISTRATION STANDARD BIBLIOGRAPHY
          Examined and Judged to be Citations Inappropriate For Use
                         in Developing the Standard
  MRID

005000458


005000565
005004172


005000331



005000518
005000332
005013483
005000333
005012583
CITATION

Ackerson, C.W. (1960) Relations of vitamin E to lipid
   metabolism.  American Journal of Clinical Nutrition 8:445-450.

Alicino, N.J.; Klein, H.C.; Quattrone, J.J., Jr.; Choy, T.K.
   (1963) Antioxidant measurement: Determination of butylated
   hydroxyanisole, butylated hydroxytoluene, and ethoxyquin in
   hydrocarbon-soluble samples.  Journal of Agricultural and Food
   Chemistry 11(6):496-498.
Anon. (1973) Common names of pesticides.
   1973.  PANS 19(2):287-306.
Revised list—February
Arscott, G.H.; Parker, J.E.; Dickinson, E.M. (1965) Effect of
   dietary linoleic acid, vitamin E and ethoxyquin on fertility of
   male chickens.  Journal of Nutrition 87(1):63-68.

Atkinson, R.L.; Swanson, A.A.j Couch, J.R.; Quisenberry, J.H.
   (1964) Effects of vitamin A, vitamin E and ethoxyquin on the
   reproductive performance of turkeys.  Poultry Science
   42(6):1380-1386.

Bartov, I.; Bernstein, S. (1966) Studies on egg yolk pigmentation.
   2. Effect of ethoxyquin on xanthopyll utilization.  Poultry
   Science 45(2):297-305.

Batzinger, R.P.; Ou, S.Y.L.; Bueding, E. (1978) Antirautagenic
   effects of 2(3)-tert-butyl-4-hydroxyanisole and of
   antimicrobial agents.  Cancer Research 38(12):4478-4485.

Benson, A.M.; Batzinger, R.P.; Bueding, E.; Cha, Y.N.; Talalay, P-
   (1978) Dietary antioxidants decrease urinary mutagenic
   metabolites of benzo(a)pyrene and enhance hepatic
   glutathione-S-transferase activities.  Federation Proceedings
   37(3):596.

Benson, A.M.; Batzinger, R.P.; Bueding, E.; Cha, Y.N.; Talalay, P.
   (1970) Dietary antioxidants decrease urinary mutagenic
   metabolites of benzo(a)pyrene and enhance hepatic glutathione-
   S-transferase activities [abstract no. 2024].  Federation
   Proceedings 37:596.

-------
005013484   Benson,  A.M.; Batzinger, R.P.; Ou, S.Y.L.; Bueding, E.; Cha, Y.N.;
               Talalay, P. (1978) Elevation of hepatic glutathione
               S-transferase activities and protection against nutagenic
               metabolites of benzo(a)pyrene by dietary antioxidants.  Cancer
               Research 38(12):4486-4495.

005000549   Bernhard, K. (1967) Vitamin E und Fettsauere-Zusammensetzung der
               Leberlipide und Depotfette von Ratten.  [Vitamin E and fatty
               acid composition of hepatic lipids and depot fats in rats.]
               Wissenschaftliche Veroeffentlichungen der Deutschen
               Gesellschaft fuer Ernaehrung 16:86-88.

005000463   Bieri, J.G. (1964) Synergistic effects between antioxidants and
               selenium or vitamin E.  Biochemical Pharmacology
               13(11):1465-1470.

005004880   Bina, J.; Jirsak, K. (1976) Toxikologicke a dermatologicke
               problemy v kabelarstve. [Toxicological and derraatological
               problems in the cable industry.]  Elektroizolacna a Kablova
               Technika.  [Electrical Insulation and Cable Technology.]
               29(l):45-55.

005000335   Biondi, G. (1976) Esiti della ricerca a livello commerciale sui
               trattamenti postraccolta antiriscaldo ed antimarciume, sulle
               CVV. "Stayman Winesap" e "Inperatore" eseguiti nell'anno 1974.
               post-harvest treatments against scald and rotting in the
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005019749   Bonora, S.; Cirllli, G. C1973) Determlnazione dell'etossichina nei
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005000339   Bushong, R.D., Jr.; Dilworth, B.C.; Day, E.J. (1972) The influence
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005000341   Cartwright, J. (1976) Physiological scald — a problem of stored
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005000451   Cawthorne, M.A.; Palmer, E.D.; Green, J. (1973) Effect of
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005000452   Cawthorne, M.A.; Palmer, E.D.; Green, J. (1973) Effect of 6-ethoxy
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005000476   Choy, T.; Alicino, N.J.; Klein, H.C.; Ouattrone, J.J., Jr.  (1963)
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005000493   Choy, T.K.; Ouattrone, J., Jr.; Alicino, N.J. (1963) A gas
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005000372   Combs, G.F., Jr. (1973) Influence of ethoxyquin on  the utilization
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005000373   Combs, G.F., Jr. (1978) Studies on the utilization  of vitamin E
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000001871   Crown Zellerbach Corporation  (1966)  Scald  Control  Data for Anjou
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005000514   Daines, R.H.  (1962) Apple scald  and  its  control by  the use of
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005000377   Daines, R.H.  (1972) Some diseases  of apples that occur in  storage
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005000495   DeLuca, A.P.; Teichman, R.; Rousseau,  J.E., Jr.; Morgan, M.E.;
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005000380   DeMille, F.; Miller, R.B.; Buchanan-Smith, J.G.  (1972)  Effects of
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005000464   Draper, H.H.; Csallany, A.S.  (1960)  Observations on the
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Dunkley, W.L.; Ronning, M.; Franke, A.A.; Robb, J. (1967)
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Dvinskaya, L. M.; Manukhina, A. I.; Stolyarova, A. G. (1975)
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005000619   Epstein, S.S.; Fujii, K.; Andrea, J.; Mantel,  N.  (1970)
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005000347   Farooqi, W.A.; Hall, E.G. (1974) Sone effects of ethoxyquin on
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005000547   Geczy, G. (1966) Kueloenboezo eredetu Kinolin  Tipusu  antioxidans
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005000354   Gorini, F.L.; Mori, P. (1973) II  cloruro di calcio contro marciumi
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   May 11, 1961 under PP0315; prepared by  [Oregon  State  Univ.,
   Agricultural Experiment Station, Dept.  of Horticulture], sub-
   mitted by Monsanto Co., St. Louis, Mo.; CDL:092596-6-C)

Hansen, E.; Mellenthin, W.M. (1967) Chemical control of
   superficial scald on Anjou pears.  Proceedings  of the American
   Society for Horticultural Science 91:860-862.

Hansen, H. (1976) Ursachen und Bekaempfung der
   Altersschalenbraeune bei "Golden Delicious" Aepfeln.  [Causes
   and prevention of superficial scald in  Golden Delicious
   apples.]  Erwerbsobstbau 18(10):152-154.

Hardenburg, R.E. (1960) Evaluation of "Santoquin"  for  Apple Scald
   Control, 1959-60.  (Unpublished study including  letter dated
   Apr 25, 1960 from R.E. Hardenburg to Paul F. Hoffman, received
   Jun 1, 1960 under PP0245; prepared by U.S. Dept. of Agriculture,
   AMS [Agricultural Marketing Service!, Market Quality  Research
   Div., submitted by Monsanto Co., St. Louis, Mo.; CDL:092522-2-A)

Hardenburg, R.E. (1967) Hot-water and chemical treatments to
   control scald on Stayman apples.  Proceedings of the  American
   Society for Horticultural Science 90:484-490.

Hardenburg, R.E. (1974) Benomyl and thiabendazole  treatments
   reduce decay of apples in polyethylene  consumer bags.  Journal
   of the American Society for Horticultural Science
   99(3):236-238.

Hardenburg, R.E.; Anderson, R.E. (1962) Chemical Control of Scald
   on Apples Grown in Eastern United States.  Washington, D.C.:
   Government Printing Office.  ( United States Department of
   Agriculture marketing research report no. 538).

Hardenburg, R.E.; Anderson, R.E. (1966) Postharvest chemical, hot
   water, and packaging treatments to control apple scald.
   Proceedings of the American Society for Horticultural Science
   87:93-99.

Hardenburg, R.E.; Spalding, D.H. (1972) Postharvest benomyl and
   thiabendazole treatments, alone and with scald  inhibitors, to
   control blue and gray mold in wounded apples.   Journal of the
   American Society for Horticultural Science 97(2):154-158.
Harman, D. (1970) Increasing the useful life span.
   Nutrition News 41(6):1,4.
Food and

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005000555
Haraan, D. (1974) Free radical theory of aging: effect of
   antioxidants and diet on life span and degenerative disease.
   Journal of Applied Nutrition 26(4):37-42.

Harman, D.;  Curtis, H.J.; Tilley, J. (1970) Chromosomal
   aberrations in liver cells of nice fed free radical reaction
   inhibitors.  Journal of Gerontology 25(1):17-19.

Harman, D.;  Eddy, D.E.; Noffsinger, J. (1976) Free radical theory
   of aging: inhibition of anyloidosis in nice by antioxidants;
   possible  mechanism.  Journal of the American Geriatrics Society
   XXIV(5):203-210.

Harman, D.;  Heidrick, M.L.; Eddy, D.E. (1977) Free radical theory
   of aging  effect of antioxidants on the immune system.  Clinical
   Research  25(2):113A.

Harnan, D.;  Heidrick, M.L.; Eddy, D.E. (1977) Free radical theory
   of aging: effect of free-radical-reaction inhibitors on the
   immune response.  Journal of the American Geriatrics Society
   25(9):400-407.

Harms, R.H.; Douglas, C.R.; Waldroup, P.W. (1964) Ethoxyquin and
   vitamin E studies in poultry.  Quarterly Journal of the Florida
   Academy of Science 27(2):131-138.

Harris, J.O., inventor; Monsanto Chemical Co., assignee (1963)
   Aminoaryl tetrahydroquinolines.  U.S. patent 3,083,181.  Mar
   26.  5 p. Cl. 260-45.8.

Herman, C.A.; Zenser, T.V.; Davis, B.B. (1979) Comparison of the
   effects of prostaglandin 1-2  and prostaglandin E-2
   stimulation of the rat kidney adenylate cyclase-cyclic AMP
   systems.   Biochimica et Biophysica Acta 582(3):496-503.
Hill, E.G. (1963) Dietary antioxidants in young swine.
   the American Oil Chemists' Society 40(8):360-364.
Journal of
Hill, E.G. (1966) Effects of methionne, menhaden oil and
   ethoxyquin on serum cholesterol of chicks.  Journal of
   Nutrition 89(2):143-148.

Hoffman, P.F., inventor; Monsanto Chemical Co., assignee (1961)
   Agricultural process.  U.S. patent 2,989,963.  Jun 27.  2 p.
   Cl. 131-144.
005000542   Honjoh, T.; Kumazawa, H.; Oosaki, M.; Yonemura, T.; Kashiwa, G.
               (1967) [Effects of oxidized fish oils and added ethoxyquin on
               the culture of rainbow trout.]  Yukagaku. [Journal of the Japan
               Oil Chemists' Society.] 16(3):135-136.

005000672   Inoue, H.; Yoneda, T., inventors; Yamamoto Chemical Industry Co.,
               assignee (1974) [Industrial production method for 6- or
               8-ulkoxy-2,2,4-trimethyl-l,2-dihydroquinoline.]  Japanese kokai
               74 35388.  Apr 1.   4 p.

-------
005000673    Inoue, H.; Yoneda, T., inventors; Yamaraoto  Chemical  Industry Co.,
               assignee (1974) [Production method  for highly purified
               6-ethoxy-2,2,4-trinethyl-l,2-dihydroquinoline.]   Japanese kokai
               74 35387-  Apr 1.  6 p.
              Journal of Veterinary Research 31(5):907-909.

005000367   Janssen, W.M.M.A. (1971) The  influence of feeding  on gizzard
               erosion in broilers.  Archiv fuer Gefluegelkunde  35(4):137-141.

005000345   Janssen, W.M.M.A.; Germs, A.C. (1973) Gizzard  erosion neat  flavor
               and vitamin E in broilers.  Acta Agriculturae  Scandinavica,
               Supplementum 19:72-78.

005000383   Jensen, L.S. (1968) Selenium  deficiency and  impaired reproduction
               in Japanese quail.  Proceedings of the Society  for
               ExperimentalBiology and Medicine 128(4):970-972.

005000384   Jirasek, L.; Kalensky, J. (1975) Kontaktni alergicky ekzera  z
               krmnych snesi zivocisne vyrobe.  [Allergic  contact eczema  from
               feeding mixtures in aminal production.]   Ceskoslovenska
               Dermatologie.  [Czechoslovakian Dermatology.] 50(4):217-225.

005000548   Johnson, B.C.; Alaupovic, P.; Crider, Q.E. (1962) Vitamin E and
               antioxidants in nutrition.  Pages 169-178,  In Mezhdunarodna
               Konferentsiya po Vitaminite, Dokladi i Suobshteniya, Sofia.
               Communications; Nov.2-4, 1960, Sofia, Bulgaria.]  Sofia,
               Bulgaria: Izdatelstvo na Bulgarskata Akademiya na Naukite.

005000671   Johnson, G.W.; Vickers, C. (1973) The identification and
               semi-quantitative assay of some fat-soluble vitamins and
               antioxidants in pharmaceutical products and animal feeds by
               thin-layer chromatography.  Analyst 98:257-267.
              Veterinaria Scandinavica 18(2):187-193.

005013063   Joner, P.E. (1977) Butylhydroxyanisol (BHA), butylhydroxytoluene
               (BHT) and ethoxyquin (EMQ) tested for rautagenicity.  Acta
               Veterinaria Scandinavica 18:187-193.

005000498   Jordan, H.V.; Bowler, A.E.; Berger, N.D. (1961) Testing of
               antioxidants against experimental caries  in rats.  Journal of
               Dental Research 40(5):378-883.

005000387   Kahl, R. (1978) Effect of antioxidants of microsomal enzymes of
               rat liver.  Naunyn-Schmiedeberg's Archives  of Pharmacology.
               Suppl. 302:R9.

005014417   Kahl, R. (1978) Effect of antioxidants on microsomal enzymes  of
               rat liver [abstract no. 33].  Naunyn-Schmiedeberg's Archives of
               Pharmacology 302:9.

-------
005012587   Kahl, R.; Deckers-Schraelzle, B.; Klaus, E. (1978) Ethoxyquin
               feeding to rats increases liver microsorae-catalyzed formation
               of benzo(a)pyrene diol epoxide-DNA adduct.  Biochemical and
               Biophysical Research Communications 85(3):933-945.

005012865   Kahl, R.; Klaus, E. (1979) Effect of dietary antioxidants on
               epoxide hydratase and on DNA modification by benzoTalpyrene
               Chemie 360(3):294.

005000389   Kahl, R.; Netter, K. J. (1977) Influence of ethoxyquin on
               microsoraal cytochrome P450.  South African Medical Journal
               52(9):370.

005000388   Kahl, R.; Netter, K.J. (1977) Influence of ethoxyquin on
               cytochrome PASO population and drug metabolizing activity of
               rat liver microsoraes.  Naunyn-Schniedeberg's Archives of
               Pharmacology. Suppl. II 297:R6.

005012586   Kahl, R.; Wulff, U. (1979) Induction of rat hepatic epoxide
               hydratase by dietary antioxidants.  Toxicology and Applied
               Pharmacology 47(2) -.217-227.

005000390   Kartha, V.N.R.; Krishnamurthy, S. (1978) Effect of vitamins
               antioxidants and sulfhydryl compounds on in vitro rat brain
               lipid peroxidation.  International Journal for Vitamin and
               Nutrition Research 48(l):33-43.

005013168   Karunajeewa, H. (1978) Effect of triticale, lucerne pellets,
               furazolidone, ethoxyquin and oxycarotenoids on egg yolk colour
               and performance of crossbred layers.  Australian Journal of
               Experimental Agriculture and Animal Husbandry 18(92):396-403.

005000472   Kent, S. (1976) Solving the riddle of lipofuscin's origin may
               uncover clues to the aging process.  Geriatrics
               36(31):12S-129,133,137.

005013355   Kent, S. (1977) Do free radicals and dietary antioxidants wage
               intracellular war?  Geriatrics 32(1):127,129,132-133,136.

005018829   Khera, K.S.; Whalen, C.; Trivett, G.; Angers, G. (1979)
               Teratologic assessment of maleic hydrazide and daminozide, and
               formulations of ethoxyquin, thiabendazole and naled in rats.
               Journal of Environmental Science and Health, Part B
               14(6):563-577.

005008362   Khera, K.S.; Whalen, C.; Trivett, G.; Angers, G. (1979) Assessment
               of the teratogenic potential of Biphenyl, ethoxyquin, piperonyl
               butoxide, diuron, thiabendazole, phosalone, and lindane in rats
               48(1):33.

005000391   King, D.W. (1964) Comparative effects of certain antioxidants on
               gestational performance and teratogeny in vitamin E-deficient
               rats.  Jorunal of Nutrition 83:123-132.

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005000505   King, D.W.  (1964) Comparative effects of  certain  antioxidants  on
               gestational performance and  teratogeny in vitamin E-deficient
               rats.  Journal of Nutrition  83(2):123-132.

005000302   Knee, M.; Bubb, M.  (1975) Storage  of  Bramley's  Seedling  apples.
               II. Effects of source of fruit, picking  date and  storage
               conditions on the incidence  of  storage disorders.   Journal  of
               Horticultural Science 50(2):121-128.

005002657   Kntekhtsyan, A.A.;  Ageev, V.N.  (1972) Sinergizm v deystvii
               antioksidantov i limonnoy kisloty.   [Synergism between the
               effect of antioxidants and critric acid.]  Pages
               230-235, In Materialy Vsesoyuznykh Nauchnykh Soveshchanii i
               Konferentsii, Vsesoyuznyi Nauchno-Issledovatel'skii i
               Tekhnologicheskii Institut Ptitsevodstva.  [Materials of
               All-Union Scientific Meetings and  Conferences, All-Union
               Scientific Research and Technological  Institute of  Poultry
               Farming, No. 5.1  Moscow, USSR.

005000620   Kogan, V.G. (1973)  Primenenie vitatnina E  i  santokhina  pri
               vyrashchivanii broiperov.  [Use of vitamin E and  santoquin  in
               broiler  production.]  Khimiya v Sel'skom Khozyaistve.

005000393   Kosaka, K.; Yoshida, M. (1973)  Fragility  of erythrocytes from
               chicks and rats  fed dilauryl succinate and related  compounds.
               Acricultural and Biological  Chemistry  37(3):501-507.

005000395   Kr'steva, M. (1973) Khimicheska borba greshchu zaparvaneto na
               yab'lkovite plodove, s'khranyavani pri khladilni usloviya.
               Restitelna Zaschita.  [Plant Protection.] 21(1):16-19.

005010315   Krasko,  I.A.; Shkunkova, Y.S. (1972) Uplyw  nyekatorykh
               antyakislyal'nikaw tlushchaw na fiziyalahichny stan i rost
               kuranyat.  [Effect of some fat antioxidants on the
               physiological condition and  growth of  chicks.]  Vestsi Akademii
               Navuk Belaruskai SSR, Seryya Sel'skagaspadarchych Navuk.
               Series on Agricultural Sciences.]  (3):115-121.

005000457   Kretchman,  D. (1965) Don't let  scald  ruin your apple market.
               American Fruit Grower 85(9):10.

005000396   Kuhns, R.V.; Arscott, G.H. (1969) Effect  of varying levels of
               ethoxyquin and vitamin E on  reproduction in white leghorn males
               fed diets high in linoleic acid.   Poultry Science
               48(5):1646-1651.

005011881   Laski, R.R.; Watts, R.R. (1973) Gas chromatography of
               organonitrogen pesticides, using a nitrogen-specific detection
               system.  Journal of the Association of Official Analytical
               Chemists 56(2):328-332.

005002658   Laugel, P.; Bieth, H. (1975) Les antioxydants.  [Antioxidants.]
               Annales d'Hygiene de Langue  Francaise—Medecine et  Nutrition
               XI(2):105-112.

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000001909   Lea, C.H. (1956) Antioxidants effective in foods.  Research
               9(-/Dec):473-477.  (Also In unpublished submission received
               Oct 13, 1958 under PP0315; submitted by Monsanto Co., St. Louis,
               Mo.; CDL:095541-9-K)

005005956   Leblond, C.;  Morgat,.F. (1971) Influence de deux inhibiteurs de
               brunissement: 1'ethoxyquine et la diphenylamine et de quelques
               substances associees, sur 1'aptitude a la conservation des
               pommes Golden delicious et Richared.  [Effect of two browning
               inhibitors: ethoxyquin and diphenylamine and some related
               substances on the storage qualities or Golden delicious and
               Richared apples.]  Arboriculture Fruitiere 211:16-23.

005000398   Levy, L. (1976) Effect of antioxidants on alkylating metabolites
               and inmunosuppression from CPA.  Federation Proceedings
               35(3):532.

005001337   Lewis, T.L.;  Martin, D. (1970) Effect of certain additives on
               calcium deposition and uptake from post harvest calcium nitrate
               applications to control bitter pit of apples.  Field Station
               Record, Division of Plant Industry, Commonwealth Scientific and
               Industrial Research Organization 9(1):1-12.

000001929   Livingston, A.L.; Bickoff, E.M.; Thompson, C.R. (1955) Effect of
               added animal fats and antioxidant on stability of xanthophyll
               concentrates in mixed feeds.  Agricultural and Food Chemistry
               3(5):439-441.  (Also In unpublished submission received Oct 13,
               1958 under PP0315; submitted by Monsanto Co., St. Louis, Mo.;
               CDL:095541-9-AG)

005002133   Lopatecki, L.E.; Burdon, H. (1966) Suppression of bull's eye rot
               of apples  and growth of Neofabraea perennans by scald control
               agents diphenylamine and ethoxyquin.  Canadian Journal of Plant
               Science 46(6):633-638.

005000527   Machlin, L.J.; Gordon, R.S. (1960) Linoleic acid as causative
               agent of encephalomalacia in chickens fed oxidized fats.
               Proceedings of the Society for Experimental Biology and
               Medicine 103:659-663.

005000516   Machlin, L.J.; Gordon, R.S.; Meisky, K.A.; Maddy, K.H. (1959)
               Relation of oxidative degradation to toxicity in certain fats.
               Poultry Science 38:579-585.

000001911   Machlin, L.J.; Gordon, R.S.; Meisky, K.H. H959) The effect of
               antioxidants on vitamin E deficiency symptoms and production of
               liver "peroxide" in the chicken.  Journal of Nutrition 67(2):
               333-343.  (Also In unpublished submission received Oct 13, 1958
               under PP0315; submitted by Monsanto Co., St. Louis, Mo.; CDL:
               095541-9-M)

005019325   Malanoski, A.J. (1978) Regulatory agency interaction in the
               control of drug residues in animal tissue.  Journal of the
               Association of Official Analytical Chemists 61(5):1192-1193.

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005000534   March, B.E.; Coates, V.; Biely, J.  (1969) Reticulocytosis  in
               response to dietary antioxidants.  Science  164(3036):1398-1400.

005000459   Marco, G.J. (1968) A rapid method for evaluation of antioxidants.
               Journal of American Oil Chemists' Society 45(9):594-598.

005000557   Marco, G.J., inventor; Monsanto Co., assignee  (1966)
               Dihydroquinolines activated with 8-hydroxyquinoline.  U.S.
               patent 3,278,308.  Oct 11.  3 p. Cl. 99-2.

 005000399   Martin, D.; Lewis, T.L.; Cerny, J. (1964) Experiments with
               "ethoxyquin" for the control of  scald in Tasmanian apples in C.
               A. atmosphere storage.  Field Station Record 3(1):81-90.

000001887   Mattus, G.E. (1960) 1959-1960 Virginia Apple Scald Tests.  (Unpub-
               lished study received Feb 10, 1960 under PP0245; prepared by
               Virginia Agricultural Experiment Station, submitted by Monsanto
               Co., St. Louis, Mo.; CDL:092522-2-B)

005000577   Mattus, G.E. (1961) Commercial control of scald.  Virginia Fruit
               49(2):142-143.

005004571   Melville, F. (1967) Ethoxyquin for  the control of scald of Granny
               Smith apples.  Western Australian Department of Agriculture
               Journal 3(1):16-17,19-20.

005000526   Mertz, W.; Schwarz, K.; Roginski, E.E. (1958) Reversal of
               respiratory decline in necrotic  liver degeneration by
               intraportal antioxidants.  Proceedings of .the Society for
               Experimental Biology and Medicine 98:808-812.

005000546   Meszaros, M.; Ruff, F.; Dufek, L. (1968) Spectrophotometric
               determination of the components  of antioxidants based on
               6-ethoxy-2,2,4-trimethyl-l,2-dihydroquinoline.  Magyar Kemiai
               Folyotrat.  [Hungarian Journal of Chemistry.] 74(10):482-484.

005002803   Miller, D.; Leong, K.C.; Knobl, G.M., Jr.; Gruger, E.H., Jr.
               (1965) Increased nutritive requirements for chicks to prevent
               exudation and dystrophy due to dietary long-chain
               polyunsaturates.  Poultry Science 44(4):1072-1079.

005015715   Ministro delta Sanita (1979) Quantita massime di residui di
               antiparassitari consentite negli alimenti.  [Maximum amount of
               permissable antiparasitic residues permitted in foods.]
               Industria Conserve.  [Canning Industry.1 54Cl):77-84.

000001375   Mispley, R.G. (1967) Ethoxyquin Fruit Wrap.  (Unpublished study re-
               ceived Jul 11, 1967 under 3222-8; prepared  in cooperation with
               Oregon State Univ., submitted by Crown Zellerbach Corp., San
               Francisco, Calif.; CDL:227996-6-A)

005000484   Mitchell, L.C. (1961) The effect of ultraviolet light (2537 A) on
               141 pesticide chemicals by paper chromatography.  Journal of
               the Association of Official Agricultural Chemists
               44(4):643-712.

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005000621   Monori, S.; Drucker, T. (1974) Gazkromatograflas raodszer
               takarraanykeverekek szintetikus antioxidans tartalmanak (BHT es
               EMQ) vizsgalatara I.  [Gas chronatographic method of
               determining the content of BHT and EMQ
               (6-ethoxy-l,2-dihydro-2,2,4-trimethyl-quinoline1) in animal feed
               mixes.]  Elelmiszervizsgalati Kozlemenyek.  [Communications on
               Food Analysis.] 20(4):149-156.

005000405   Monroy, H., inventor;  (1971) Novel 1,2-dihydroquinolines and
               process and apparatus for the obtention thereof.  South African
               patent 7,102,702.  Dec  1.  26 p.

005000404   Monroy, H., inventor;  (1974) Apparatus for the manufacture of
               novel 1,2-dihydroquinolines.  Canadian patent 944,135.  Mar 26.
               23 p.

000001876   Monsanto Company (19??) Amount, Frequency and Time of Application
               of the Pesticide Chemical: [Ethoxyquinl.  (Unpublished study
               received on unknown date under unknown admin, no.; CDL:120377-
               7-B)

000001910   Monsanto Company (19??) Factors Effecting Oxidation of Fats in
               Feeds and Consequences  of Such Oxidation.  (Unpublished study
               received Oct 13, 1958 under PP0315;  CDL:09554l-9-L)

000004150   Monsanto Company (19??) Methods for the Analysis of Santoquin in
               Dehydrated Forages, Meat, and Eggs.   Undated methods.  (Unpub-
               lished study received Oct 13, 1958 under PP0315; prepared in
               cooperation with U.S. Dept. of Agriculture; CDL:095541-9-E)

000001879   Monsanto Company (19??) Reasonable Grounds in Support of the Re-
               quest: fSantoquinl.  (Unpublished study received on unknown date
               under unknown adnin. no.; CDL:120377-7-E)

000014306   Monsanto Company (19??) Results of Tests on the Amount of Pesidue
               Remaining, Including a  Description of the Analytical Method
               Used: [Ethoxyquin].  (Unpublished study received Feb 10, 1960
               under 524-117;  CDL:003957-C)

000019875   Monsanto Company (19??) Santoquin Residues in Apples.  (Unpublished
               study received  on unknown date under 524-117; CDL:240842-C)

000019873   Monsanto Company (19??) The Name, Chemical Identity and Composition
               of the Pesticide Chemical: [Santoquinl.  (Unpublished study re-
               ceived on unknown date  under 524-117; CDL:240842-A)

000001881   Monsanto Company (19??) The Name, Chemical Identity, and Composi-
               tion of the Pesticide Chemical: [Stop Scald).  (Unpublished
               study received  Feb 10,  1960 under 524-117; CDL:003957-8-A)

000001931   Monsanto Company (19??) Toxicology of Oxidized Santoquin.  (Unpub-
               lished study received Oct 13, 1958 under PP0315; CDL:
               095541-9-AI)

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000001903
000001882
000001928
000001904
000001927
000001883
000019874
000001878
000001892
000001898
000001899
Monsanto Company (1956) A Description of Practicable Methods  for
   Determining the Quantity of Such Additive  in or  on  Food  and  Any
   Substance Formed in or on Food Because of  Its  Addition:  [San-
   toquin].  (Unpublished study received Oct  13,  1958  under PP0315;
   CDL:095541-9-D)

Monsanto Company (1956) Full Report of  Investigations  Made  with
   Respect to the Safety of the Pesticide Chemical:  [Ethoxyquinl-
   Summary of studies 003957-8-E through 003957-8-1; 003957-8-K
   through 003957-8-P; 003957-8-S through 003957-8-U.   (Unpublished
   study received Feb 10, 1960 under 524-117; CDL:003957-8-B)

Monsanto Company (1956) A Description of Practicable Methods  for
   Determining the Quantity of Such Additive  in or  on  Food  and  Any
   Substance Formed in or on Food Because of  Its  Addition.  (Un-
   published study received Oct 13, 1958 under PP0315;  CDL:09554l-
   9-AF)

Monsanto Company (1957?) Full, Reports of Investigations Made  with
   Respect to the Safety for Use of the Additive  (Santoquin)  In-
   cluding Full Information as to the Methods and Controls  Used in
   Conducting Such Investigations.  (Unpublished  study  received
   Oct 13, 1958 under PP0315; CDL:095541-9-F)

Monsanto Company (1957) All Relevant Data Bearing on the .Physical
   or Other Technical Effect Such Additive (Santoquin)  Is Intended
   to Produce, and the Quantity of Such Additive Required to
   Produce Such Effect.  (Unpublished study received Oct 13,  1958
   under PP0315; CDL:095541-9-AE)

Monsanto Company (1959) Reasonable Grounds In Support  of the  Re-
   quest.  (Unpublished study received  Feb 10, 1960 under 524-117;
   CDL:003957-8-D)

Monsanto Company (1959) Santoquin on Apples.  Method dated  Nov  5,
   1959.  (Unpublished study received on unknown  date  under 524-
   117; CDL:240842-B)
Monsanto Company (1959) Santoquin on Apples.  Includes  method dated
   Nov 5, 1959.  (Unpublished study received on unknown date  under
   unknown admin, no.; prepared in cooperation with Cornell Univ.
   and Univ. of Rhode Island; CDL:120377-7-D)

Monsanto Company (1960?) Reasonable Grounds in Support  of the Re-
   quest: [Ethoxyquin].  (Unpublished study received May 11,  1961
   under PP0315; CDL:092596-6-A)

Monsanto Company (1960) 1959-1960 Virginia Apple  Scald  Tests.   (Un-
   published study received May 11, 1961 under PP0315;  CDL:
   092596-6-G)

Monsanto Company (1961) 1960-61 Virginia Apple Scald Tests.   (Un-
   published study received May 11, 1961 under PP0315;  CDL:092596-
   6-H)

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005000545   Moore, T.;. Sharaan, I.M. (1964) Mode of action of vitanin E, and
               its substitutes.  Internationale Zeitschrift fuer
               Vitaminforschung.  [International Review of Vitamin Research.]
               34(3):317-325.

005000567   Morehouse, N.F. (1948) Experiments on the use of quinoline
               compounds for the prevention of blackhead in turkeys.  Journal
               of Parasitology 34(6):18.

005000553   Mowry, D.T.; Schlesinger, A.H., inventors; Monsanto Chemical Co.,
               assignee (1953) Quinoline derivatives as herbicides.  U.S.
               patent 2,661,277.  Dec 1.  2 p. Cl. 71-2.5.

005016609   Mueller, H. (1979) Markierung von ethoxyquin mit kohlenstoff-14.
               Compounds and Radiopharmaceuticals XVI(3):473-476.

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005000480   Nash, R.A.; Skauen, D.M.; Purdy, W.C. (1958) The correlation of
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005000481   Nelson, L.F.; Diaz, F.;  Catron, D.V. (1962) Vitamin A levels plus
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005000579   Olcott, H.S. (1962) Marine products.  Pages 173-189, In Symposium
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005000478   Oldfield, J.E.; Sinnhuber, R.O.; Rasheed, A.A. (1963) Nutritive
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005002805   Padfield, C.A.S. (1966)  Stalk-end scald of Sturmer apples.
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Parke, D.V.; Rahim, A.; Walker, R. (1974) Inhibition of rat
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Parrish, D.B.; Zimmerman, R.A.; Sanford, P.E.; Hung,  E. (1963)
   Utilization of alfalfa carotene and vitamin A by growing
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Pascal, G. ; Takigawa, A.; Durand, G. (1978) Effets metaboliques de
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Pennwalt Corporation (1973) Experiments with Deccoquin at USDA Lab-
   oratory — Wenatchee,  Washington.  (Unpublished study received
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Phillips Petroleum Company, assignee (1958) Polymeric
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   May 21.  1 p. int. Cl. -2- C 08F.

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005012504   Phillips, J.C.; Topp, C.E.; Mendis, D.; Walker, R.; Gangolli,-  S.D.
               (19781 The effect of ethoxyquin on  the hepatotoxicity of
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005000460   Pieniazek, S.A.; Christopher, E.P. (1945) Effect of pre-storage
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005000540   Pierson, C.F. (1967) The control of storage scald on golden
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005000473   Pierson, C.F.; Schomer, H.A. (1967) Chemical and non-chemical
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005000491   Pollard, C.J.; Bieri, J.G. (1960) Studies of the biological
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005000413   Porritt, S.W.; Meheriuk, M. (1968) Application of chemicals  for
               control of apple scald.  Canadian Journal of Plant Science
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005000414   Porritt, S.W.; Meheriuk, M. (1970) Chemical control of scald on
               waxed apples.  Canadian Journal of  Plant Science 50(3):313-317.

005000415   Povarov, L.S.; Mikhalov. B.M., inventors;  (197H Process for  the
               production of substituted 1,2-dihydroquinolines.  British
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               07D 33/12 39/00.

005000416   Pratella, G.; Biondi, G. (1969) Influenza della conservazione  in
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005000576   Raphael, T.D.; O'Loughlin, J.B. (1962) Superficial scald in Granny
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000019870   Rexolin Chemicals AB (19??) Rexoquin (Ethoxyquin).  (Unpublished
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005000447   Rizk, S.S.; Ragheb, S.A.; Khalil, R.I.; Salama, S.B. (1974)
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005000417   Rosati, P.; Gorini, F.; Faedi, W.; Sozzi, A. (1977) Attitudine
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               Frutticoltura.  [Fruit Growing.1 39(IX):29-36.

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005000494   Rousseau, J.E.,-Jr.; Eaton, H.D.; Teichman,  R.;  Heltnboldt,  C.F.;
               Jungherr, E.L.; Bacon, E.L.; Dolge, K.L.;  Beall,  G.;  Moore,
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               carotene by Holstein calves.  Journal of  Dairy  Science
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005000418   Rudra, D.N.; Dickerson, J.W.T.; Walker, R. (1975)  The effect  of
               some antioxidants on lipofuscin accumulation  in rat brain.
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005000676   Sawatani, K.; Gono, T.; Tanaka, E.; Oka, K.;  Enomoto, Z.,
               inventors; Yoshitomi Pharmaceutical Industries, assignee  (1973)
               2-dihydroquinoline.]  Japanese patent specification 73  12744.
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005000573   Schubert, O.E.; Stevens, L.P. (1961) Control Apple Storage Scald.
               Morgantown, W.Va.: West Virginia University
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000001888   Scientific Associates (1960) Certificate of  Analysis: A  Study of
               the Interference of Insecticide Residues on the Assay of
               Santoquin in Apples.  (Unpublished study  received Feb 10,  1960
               under PP0245; submitted by Monsanto Co.,  St. Louis, Mo.; CDL:
               092522-2-C)

000003238   Scientific Associates (1960) Certificate of Analysis: Santoquin
               Concentrated Emulsion Inhalation Study.   (Unpublished study
               received Feb 10, 1960 under 524-117; submitted  by Monsanto Co.,
               St. Louis, Mo.; CDL:003957-8-G)

000002202   Scientific Associates (1960) Certificate of Analysis: Santoquin
               Inhalation Study.  (Unpublished study received  Feb 10, 1960
               under 524-117; submitted by Monsanto Co., St. Louis, Mo.; CDL:
               003957-8-F)

000001891   Scientific Associates (1960) Santoquin Residue Studies: Stop Scald
               Formulation.  (Unpublished study received Nov 1» 1960 under
               PP0315; prepared in cooperation with Oregon State College and
               Cornell Univ., submitted by Monsanto Co., St. Louis,  Mo.;
               CDL:090335-1-B)

005000462   Scott, K.J.;  Roberts, E.A. (1966) The relative effectiveness of
               diphenylamine and ethoxyquin in Inhibiting superficial scald on
               Granny Smith apples.  Australian Journal of Experimental
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005000422   Shemet, R.S.  (1975) Profilaktika belomyshechioi boleni indyushat.
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005000524   Shull, R.; Alfin-Slater, R.B.; Deuel, H.J., Jr.; Ershoff, B.H.
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               95:263-265.

005000525   Shull, R.L.; Ershoff, B.H.; Alfin-Slater, R.B.  (1958) Effect  of
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               guinea pigs.  Proceedings of the Society  for Experraental
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000001913   Siedler, A.J.; Enzer, E.; Schweigert, B.S.;  Riemenschneider,  R.W.
               (1956) Vitamin A and carotene stability in feeds containing
               antioxidant-treated animal fats.  Agricultural and Food Chemis-
               try 4(12):1023-1029.  (Also In unpublished submission received
               Oct 13,  1958 under PP0315; submitted by Monsanto Co., St.  Louis,
               Mo.; CDL:095541-9-0)

005000537   Silber, G.  (1964) Effectiveness of some chemicals for the
               prevention of weather fleck of field-grown tobacco.  Tobacco
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000001908   Singsen, E.P.; Matterson, L.D. (1956?) The Function of  Antioxidants
               in Poultry Feeds.  (Unpublished study received Oct 13, 1958
               under PP0315; prepared by Univ. of Connecticut, submitted  by
               Monsanto Co., St. Louis, Mo.; CDL:09554l-9-J)

005000499   Sive, A. (1965) The effects of temperature,  ethoxyquin  and
               diphenylamine on the incidence of'storage scald on Grand
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005000423   Skaare, J.U. (1976) The effect of ethoxyquin on the intestinal
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005012506   Skaare, J.U.; Nafstad, I. (1979) The distribution of
               14C-ethoxyquin in rat.  Acta Pharmacologica et Toxicologica
               44(4):303-307.

005000424   Skinner, W.A.; Johnson, H.L.; Ellis, M.; Parkhurst, R.M. (1971)
               Relationship between antioxidant and antihemolytic activities
               of vitamin E derivatives in vitr o .  Journal of Pharmaceutical
               Sciences 60(4):643-645.
                                                 f

000001896   Snock, R. (1959?) Wealthy—Orchard A East: Picked and Composited
               9/8/59.  (Unpublished study received May  11, 1961 under PP0315;
               prepared by Cornell Univ., submitted by Monsanto Co., St.  Louis,
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000001900   Smock, R. (1960) Stop Scald Injury Study—1960.  (Unpublished study
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000001897   Smock, R. (1961) Wealthy 1960.  (Unpublished study received May 11,
               1961 under PP0315; prepared by Cornell Univ., submitted by
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005000570   Smock, R.M. (1956) A promising new method of scal'J control.
               Proceedings, Mew York State Horticultural Society 101:102-104.

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Steed, J.N. (1963) New materials to check superficial scald of
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Stevenson, C.D. (1962) Factors influencing the incidence and
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Stevenson, C.D.; Blake, J.R. (1961) Investigations into the
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Stiles,  W.C.; Eggert, F.P.; Goff,  K.R. (1964) Chemical prevention
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Stroza,  I.; Utno, L.; Vevere, L. (1975) Nekotoroye izmeneniya v
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   chickens under the influence of experimental food
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Sullivan, P.O.; Calle, L.M.; Shafer, K.; Nettleman, M. (1978)
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005002804   Surgant, J.M., inventor; Monsanto Chemical Co., assignee (1963)
               Aqueous mixture of surface active agents.  U.S. patent
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005000426   Szkolnik, M. (1972) Prevention of Botrytis and Penicillium rots
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               Phytopathology 62(5):500.

005002607   Takeuchi, M. (1972) [Effect of vitamin E and ethoxyquin on
               absorption of lipid hydroperoxide in carp.]  Nippon Suisan
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005000427   Takimoto, K., inventor; Mitsubishi Monsanto Chemical Co., assignee
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005002491   Ter Meulin, U.; Walker, R. (1977) Untersuchungen zum
               enterohepatischen Kreislauf des Antioxydans Aethoxygin.
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000001907   Thompson, C.R.; Emerson, 0., comps. (1938?) Effect of Exposing
               Santoquin to Air on Celite and Alfalfa Meal.  (Unpublished study
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               St. Louis, Mo.; CDL:095541-9-I)

005000471   Tindale, G.B. (1967) Scald inhibitors for apples.  Fruit World
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005000539   Tindale, G.B. (1967) Scald inhibitors for apples.  Victorian
               Horticulture Digest ll(l):30-32.

005000429   Tinsley, I.J.; Arscott, G.H.; Lowry, R.R. (1970) Fertility and
               testicular fatty acid composition in the chicken as influenced
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005000430   Tinsley, I.J.; Arscott, G.H.; Lowry, R.R. (1971) Fertility and
               testicular fatty acid composition in the chicken as influenced
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005017454   Tirzit, G.D.; Krustinya, B.V.; Dubur, G.Y. (1978) Ingibirovanie
               avtookisleniya kholesterina.  [Inhibition of the autooxidation
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005000509   Tollerz, G.; Lannek, N. (1964) Protection against iron toxicity  in
               vitamin E-deficient piglets and mice by vitamin E and synthetic
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005000431   Tompsett, A.A. (1969) Beware of scald in bulk Bramleys.
               Commercial Grower 1969(3841):20.

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005000432   Treccani, C. P.; Cattaneo, M.; Del Re, A.A.;  Criselli,  F.  (1974)
               Trattamenti anti-riscaldo  a base  di etossichina  e loro  residui
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005000434   Tucker, R.E.; Mitchell, G.E., Jr.; Cannon,  W.N.  (1971")  Tocopherol
               loss in steers  receiving nitrate  or ethoxyquin.   Journal  of
               Animal Science  33(1):302.

005000535   Tugwell, B.L. (1968)  Chemical treatment: the  answer  to  fruit
               scald.  South Australia Journal of Agriculture 71(fl):296-298.

000001895   U.S. Department of Agriculture, Agricultural  Marketing  Service
               (1960) 1959-1960 Storage Season:  [Santoquinl.  (Unpublished
               study received  May  11,  1961 under PP0315;  submitted by  Monsanto
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005000436   Ugazio, G.; Torrielli, M.V.;  Burdino, E.;  Sawyer, B.C.;  Slater,
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005004327   Uturashvili, E.A.  (1973) Etoksikhin  preduprezhdaet zagar.
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005000679   Val'dman, A.; Strozha, I.K.;  Ozol, A.Y.; Kushak, R.I.; Fel'dman,
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005000488   VanDeren, J.M., Jr.;  Jaworski, E.G.  (1966) Ethoxyquin (Santonin)
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005000489   VanDeren, J.M., Jr.; Jaworski, E.G.  (1967) Collaborative study of
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005000490   VanDeren, J.M., Jr.; Jaworski, E.G.  (1968) Collaborative study of
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005000435   Vanderhoek, J.Y.; Lands, W.E.M. (1973) The inhibition of the fatty
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005000438   Veinbergs,  Z.;  Andersons, P-  (1975)  Vliyanie antiokislitelei na
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0050156H3   Vettorazzi, G. (1977) State of the art of the toxicological
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005000439   Viard, P.; Chapon, J.F. (1977) Traitenents anti-echaudure des
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005000551   Vorob'eva, R.P.; Zalukaev, L.P.; Ivanova, E.N. (1967) [Electron
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005000552   Vorob'eva, R.P.; Zalukaev, L.P.; Ivanova, E.N. (1967) [Oscillator
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005015940   Wang, C.Y.; Baker, J.E. (1979) Effects of two free radical
               scavengers and intermittent warming on chilling injury and
               polar lipid composition of cucumber and sweet pepper  fruits.
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005002608   Watanabe, T.; Tsuchiya, T.; Hashimoto, Y. (1967) [Effect of  DPPD
               and ethoxyquin on the muscular dystrophy of carp induced  by
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005001031   Wattenberg, L.W. (1972) Inhibition of carcinogenic and toxic
               effects of polycyclic hydrocarbons by phenolic antioxidants and
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005015820   Wattenberg, L.W. (1979) Inhibitors of carcinogenesis.  Pages
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005000441   Weilenmann, H.R.; Hurter, J.; Stoll, K.; Temperli, A. (1972)
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               santoquin on apples with fluorescence spectrophotometry and
               thin layer chromatography.]  Lebensiaittel Wissenschaft +
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005000442   Wills, R.B.H.; Scott, K.J. (1977) Evaluation of the use  of
               butylated hydroxytoluene to reduce superficial scald  of apples.
               Scientia Horticulturae 6(2):125-127.

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000001913   Wilson, R.H.; DeEds, F. (1953?) Progress Report: Toxlcity  Studies
               on 6-ethoxy-2,2,4-triraethyl-l,2-dihydroquinoline.  (Unpublished
               study received Oct 13, 1953 under PP0315; submitted by  Monsanto
               Co., St. Louis, Mo.; CDL:095541-9-T)

005001101   Workman, M. (1963) Controlled atmosphere studies on Turley apples.
               Pages 126-134, In Proceedings of the American Society for
               Horticultural Science. V. 83.  St. Joseph, Mich.:  American
               Society for Horticultural Science.  (Purdue University,
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005003207   Zalukaev, L.P.; Vorob'eva, R.P.; Vanina, T.A. (1967)
               Spektroskopicheskie issledovaniya nekotorykh gidrirovannykh
               khinolinov.  [Spectroscopic studies of some hydrogenated
               quinolines.l  Khimiya Ceterotsiklicheskikh Soedinenii,  Sbornik.

005000446   Zenser, T.V.; Davis, B.B. (1978) Antioxidant inhibition of
               prostaglandin production by rat renal medulla.  Metabolism,
               Clinical and Experimental 27(2):227-233.

005000550   Zentz, C. (1964) Die Anwendung der Duennschichtichromatographie
               fuer die Analyse natuerlicher tind synthetischer Antioxydantien.
               antioxidants.]  Landwirtschaftliche Forschung.  Sonderheft
               18:152-154.

005009940   Zhedek, M.S.; Anderson, P.P. (1968) Vliyanie antikisliteley na
               ustoychivost karotina v khvoynoy nuke i na ego ispolzovanie v
               organizme.  [Effect of antioxidants on the stability of
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               Khimiya v Sel'skom Khozyaistve.  [Chemistry in Agriculture.]
               6(9):695-698.

005006340   Zilber, Y.A.; Dubur, G.Y.; Kumsar, K.K.; Velena,  A.K.  (1971)
               Vliyanie antioksidantov na pereokislenie bimolekuliarnykh
               fosfolipidnykh membran.  [Effect of antioxidants on
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                                    Section

Faun Chemical Handbook. (1979) Meister  publishing.   Willoughby.  Chio.

Ihe Federal Insecticide, Fungicide, and Rodenticide Pet, as amended in 1978,
   7th U.S. Code, Chapter 135, 61  Statute 163.78 Statute 190.

Pesticide Process Encyclopedia,  1977 Noyes  Data Corp., Park Ridge, New
   Jersey.

Pesticide Index;  Basic information on  the  chemicals used as active
   components ot pesticides.; Martin, H., and  fcrthington, C.R., eds., 1977.
   5th ed., British Corp. Protection Council,  Worcestershire, England.

U.S. Environmental Protection Agency (1978a);  Proposed Guidelines for Regis-
   tering Pesticides in the United States.   Federal Register, 43 (132) 29696.

U.S. Environmental Protection Agency  (1978b);  Proposed Qaidelines for Regis-
   tering Pesticides in the United States;  Hazard Evaluation: Humans and
   Domestic Animals,   federal Register, 43(163) 37336.

U.S. Environmental Protection Agency  (1980); Regulations for the Enforcement ot
   the Federal  Insecticide, Fungicide,  and  Rodenticide Act, Title 40, Chapter
   1, Part 162.

U.S. Environmental Protection Agency (in press) Proposed Guidelines for Regis-
   tering Pesticides in the United States.   Subparts G (Product Performance)
   H (Label Development).
       
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