T981
s>EPA
Butoxicarboxime
3-(methylsuflonyi -o-
[(methylamino) carbonyl]
oxime-2-butanone

          Pesticide Registration
          Standard

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                                                 25941
             BUTOXICARBOXIME
     Pesticide  Registration  Standard
 Denise Keehner  -  Project  Manager  (SPRD)
 Michael McCommas  -  Project  Manager  (SPRD)

 Jay Ellenberger - Product Manager  (RD)
 Dennis Edwards  -  Product  Manager  (RD)
              August,  1981
Office of Pesticides  and  Toxic  Substances

    Environmental  Protection Agency
            401  M  Street,  SW
         Washington,  DC    20460

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                               TABLE OF CONTENTS

                                                               Page No.

Chapter One
How to Register Under a Registration Standard ................. 1-1

Chapter Two
Agency Regulatory Position on Butoxicarboxime ................. 2-1

    A.  Introduction
    B.  Description of Chemical
    C.  Regulatory Position
    D.  Regulatory Rationale
    E.  Criteria for Registration Under the Standard
    F.  Required Labeling

Chapter Three
Data Requirements and Data Gaps ............................... 3-1

    A.  Introduction
    B.  Table A:  Generic Data  Requirements and Data Gaps  for
        Butox icar box ime
        Table B:  Product Specific Data Requirements and Data Gaps
        for Proposed Manufacturing-use Butoxicarboxime
    C.  Table C:  Product Specific Data for Formulated Cardboard. Pin
        Butoxicarboxime Products

Chapter Four
Product Chemistry of Butcxicarboxime .......................... 4-1
    A.  Manufacturing- use Butoxicarboxime
        1 .  Product Chemistry Profile
        2.  Physical and Chemical Properties
    B.  Formulated Cardboard Pin
        1 .  Product Chemistry Profile

Chapter Five
Environmental Fate of Butoxicarboxime ......................... 5-1

    A.  Use Profile
    B.  Butoxicarboxime
        1 .  Environmental Fate Profile
        2.  Exposure Profile

Chapter Six
Toxicology of Butoxicarboxime ................................. 6-1

    A.  Manufacturing- use Butoxicarboxime
        1 .  Toxicology Profile
    B.  Formulated Cardboard Pin
        1 .  Toxicology Profile

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Chapter Seven
Residue Chemistry of Butoxicarboxime	7-1

Chapter Eight
Ecological Effects of Butoxicarboxime	 8-1

Case Bibliography	 9-1

    A.  Guide to Use of Bibliography
    B.  Bibliography

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                       •%>' TO REGISTER 'JNEER A P-EGISTP-ATICM  STANDARD

                     ""> *"  u'— o 3 "" ~ ^'^a *"*"*
    3.  Pjr^CSO  Of  Ch3  3 r 3 "..Card
    •~.  Requirement  to  Re roister Under the Standard
    D.  "Product Specific" Data  and "Generic" Data
    E.  Data Compensation  Recui regents under FIFRA 3(c)(l)(D)
    F.  Obtaining Cata  to  .-ill "Cata Gaps"; FIFRA 3(c)(2}(5)
    G.  Amendments  to the  Hcar.dard

   jrsanizaticn cf  th-
This first; chapter  o.".~'_?.ir.3  -.he purpose of a Registration  Standard and
surrrnarizos tins  local  ~rir.c?ipies involved in rcxjistcr'nc cr rorscistsrinc L2nceiT
a Standard.  IV.e  =ccor.r"  chap tar sees forth the rscijire~cr.c.s thac rr.usc 'oe rrxst: to
obtain or retain  regiscraticn for products covered by  this particular
Registration Standard.   In the regaining chapters, the .-^cncv- revie'.vs the
available data  by scientific discipline, discusses the Aconcy's  conccrr^ with
the identified  potential hazards, and logically develops  the conditions and
requirements that ^cuic  reduce those hazards to acceptable- levels.

3. Purpose of the Standard

Section 3 of the  Federal Insecticide, Fungicide, and Pccenticice Ant (FTF2A)
provides that "rxo person in  any State Tay distribute,  sell,  offer for sale,
hold for sale,  ship,  deliver for shipment, or receive  (and having so received)
deliver or offer  to deliver, to ?.ny person any pesticide v.r.ich is not
registered with the .•^c.tiinistratcr [of E?Aj."  Tb approve  the  registration of a
pesticide, the  .^cninistrator ~ust find, pursuant to Section 3(c)(51  that:

   "(A)  its oorr.position is  such as to warrant the proposed claims for it;

    ;B)  its labeling ard other material required to 'oe suc.T.ittc-d ccrrply
         with the requircmencs of this Act;

    (C)  it will  perform its intended function without unr^so'^bie  adverse
         effects  en the  environment; and

    (D)  when used  in accordance with widespread and ccnmcnly recognized
         practice it  will not generally cause unreasonable adverse effects
         en the env ironment."

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

First, EPA and  its  predecessor agency, the United States Department  of
Agriculture (USCA), 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.

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Soccnd, over the years, as a result of  inevitable and  continuing  advances in
scioncific knowledge, .-nethcdology, and  policy,  the daca  'case  for  many
pesticides came to be considered  inadequate by  current scientific and
roculsccry standards.  Given the  long history of pesticide  regulation in
several agencies, it is even likely that materials jay 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  1578  (43 FR 29686,
July 10, 1978 and 43 FR 37336, August 22, 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  reregister all
previously registered products, so as to bring  their registrations and their
data bases into compliance with current requirements  [See FIFRA Section 3(g)j.

racing 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.  (Jnder 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
chat active ingredient.  These conditions and requirements, all of which must
be met to obtain or retain full registration or reregistration under Section
3(c)(5) of FIFPA, include the submission of needed scientific  data which the
Agency does not row have, compliance with standards of toxicity,  composition,
labeling, and packaging, and satisfaction of the data  compensation provisions
of FIFFA 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 seme 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  cr Federal government as being
competent to use the pesticide safely,  responsibly, and  in  accordance with
label directions.  A restricted-use pesticide can have other  regulatory
restrictions [40 CFR 162.11(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

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is stated in the second chapter.

C. Peguire.Tent to Rare-lister under  the  Standard

?I??A Section. 3(c), as ar.er.ded  in 1978,  directs  SPA to reregister all currently
registered products as expcditiously 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
oommerce, must apply for reregistraticr..   His application must contain proposed
labeling that complies with this Standard.

EPA will issue a notice of intone to cancel  the  registration of any currently
registered product to which tr.is Standard applies  if the registrant fails to
comply with the procedures for  roregistraticr. sot  forth in the Guidance Package
which accompanies this Standard.

D. "Product Specific" Data and  "Generic"  Data

In the course of developing this Standard, E?A has determined the types of data
needed for evaluation of the properties  and off-nets of products to whicn the
Standard applies, in the disciplinary areas of Product Chemistry,  Environmental
Fate, Ibxicoiogy, Residue Chemistry, and  Zoological Effects.  T!-.ese
determinations are based primarily on the data Guidelines proposed in 43 FR
29696, July 10, 1978; 43 FR 37336", August 22, 1978; and 45* FR 72948,
November 3P 1980, 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 ceen waived.  Cn the other hard, in
seme cases studies not required by  the Guidelines  may be needed oecause of the
particular composition or use pattern of  products  the Standard covers; if so,
the Standard explains the Agency's  reasonina.   Data guidelines have not yet
been proposed for the Residue Chemistry  discipline, but the requirements for
such data have been in effect for some  time and  are,  the Agency believes,
relatively familiar to registrants.  Cata which  we have found are needed to
evaluate the 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
third chapter.)  The various kinds of data normally required for registration
of a pesticide product can be divided into two basic groups:

  1. Cata that are  product specific  ,  i.e. data that relate only
     to the properties or effects of a  product with a particular
     composition (or a group of products with closely similar
     composition); and

  2. Generic data that pertains to  the  properties  or effects of a
     particular ingredient, and thus are  rciavant  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

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characterize the product's particular composition  ard  physical/chemical
properties (Prcduct Chemistry), and  to characterize  the product's acute
toxicity (which is a function of its total ccmpcsiticn).   The  applicant for
registration or rcregistracion of any product, whether it is a manufacturing-
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  o?A to evaluate the
product.  For such purposes, "product specific" data en 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, ail
products in the group, the Standard so indicates.)   "Product specific" data on
the efficacy of particular end-use products are 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 concern 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 guidelines, 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
guidelines,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 formulaced 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 end-use products with than use
pattern.  Thus, for example.- a subchronic oral cosing  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  reregisters  his product.  An
applicant for registration of a new product under  this Standard may similarly
request approval for only certain use patterns.

E.  ^Exclusive Use" and "Data Compensation" Under  FIFRA Section 3(C)(1)(D)

FIFRA section 3(C)(1)(D)(i) provides special "exclusive use"  protection for
certain data concerning any pesticide product  first  registered after September
30, 1978, that contains an active ingredient not  found in any  previously

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registered product.   (Plant-Pin  , with  its  new active  ingredient
butoxicarboxime, is such as product.)

The statute provides  Usat d?ca submitted to support  the  original
registration of such  a product may not  be considered by  EPA to
support the registration of another firm's  product unless  the
original data submitter has consented in writing.  This  period of
"exclusive use" lasts for 10 years after the  initial registration.
Wacker Chemie's registration for its Plant-Pin product  was
issued on May 28, 1979.  The Chapter III data charts contained
within this standard  indicate those data which are subject to
this "exclusive use"  provision.

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

  1.  The data were first submitted to  SPA  (or to its  predecessor
      agencies, QSDA  or FDA), on or after January 1, 1970;

  2.  The data were submitted to EPA (or USDA or  FDA)  by seme
      other applicant or registrant in  support of an application
      for an experimental use permit, and amendment  adding a new
      use to a registration, or  for registration, or to  support
      or maintain an  existing registration;

  3.  They are the kind of data  which are relevant to  the  Agency's
      decision to register or reregister the  applicant's product
      under the Registration Standard,  taking into account the
      applicant's product's composition and intended use pattern(s);

  4.  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) frcm  the  duty to offer to pay
      compensation..   (This exemption applies  to the  "generic"  data
      concerning 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.

An applicant for reregistration  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 SPA 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"

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data submitted by another firm.  In many,  if  not  in  most cases,  data which are
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
do.ermining whether the applicant's produce is registrabie.   There may be
cases, however/ where because of close similarities  between  the  composition of
two or rare products, another  firm's data rnay suffice to allow EPA to evaluate
seme or ail of the "product specific" aspects of  the applicant's product.  In
such a case, the applicant may choose to cite those"data instead of submitting
data fro?, 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 rercgistration of a manufacturing-use
product, and each applicant for registration  or reregistration of an end-use
product, who is rot exempted by FIFPA Section 3(c)(2)(D), must octroiy with the
Section 3(c)(i)(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 reregistration (or new registration) under this  Standard is  found in the
Guidance Package for this Standard.

F. Ccteinir.g Data to Fill "Data Gaps"; FIF3A  3(c)f2}(3)

Scrre 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 Aconcy (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
.Strv.-vr.arc as "data gaps".

:!".'•. Action 3(c)(2)(3), added to FIFPA by the Congress in  1973, authorizes
EPA ~c require registrants to wr.cro 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 to fill the data gaps
ic£ntifiec by a section 3(c)(2/(B) order, his product's registration may be
suspended until the data are 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 Stc-.^dard lists, in the third chapter,  the "generic" data gaps and notes the
c.asses of products to which these data  gaps  pertain.   The Standard also points
out that to bo registrable under the Standard,  a  product must be supported by
certain required "product specific" data.  In some cases, the Agency may
possess 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 reregistering  currently registered products, EPA will

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issue Section 3(c)'2)(3) directives  requiring  the  registrants to take
appropriate steps  co  fill ail  identified  data  caps — whether the data in
question ars "product specific" or  "generic" — in accordance with a schedule.

Persons '~r.c wish  to obtain  registrations  for new products under this Standard
wiii 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  bv recistrants to comply with
Section 3(c}(2)(3).

G. Amendments to  the Standard

Applications for  registration which  propose uses or formulations that are not
presently covered by the Standard, or which present product compositicns,
product chemistry data, hazard data,  toxicity  levels, or labeling that do net
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 Tay 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 rate.
This "cut-off" date is stated at the beginning of  the second chapter.  Any
subsequent data suonissicns and any  approved amendments will be incorporated
into the registration Standard by means of addenda, which are available :or
inspection at EPA in Washington, D.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.

Vihile the ?.egistraticn 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 seme inert  ingredients  and impurities.
Independent of the development of any one Standard, the Agency has initiated
the evaluation of seme inert pesticide  ingredients.  Where the Agency has
identified 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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                                   CHAPTER II


                      AGENCY POSITION CN  BUTOXICARBOXIME

 Introduction

This chapter describes  in detail  the Agency's  regulatory position on products
which contain butoxicarboxime as  the sole active ingredient.   The regulatory
position adopted by the Agency  incorporates a  number of considerations.
Foremost among these considerations is  an analysis  of the registrability of
products containing butoxicarboxime based on the risk criteria found in Section
162.11(a) of Title 40 of the U.S.  Code  of Federal Regulations.  The Agency's
determination and the rationale for its determination are presented below.

In addition to this decision, standards of product  composition,  acute toxicity,
and use are established.  The rationale for establishing a particular standard
follows the presentation of the standard.   Regulatory actions such as requiring
the addition of a bitter tasting  ingredient to decrease the possibility of
children ingesting fatal quantities of  butoxicarboxijtie are prescribed,  and any
additional data to support the  registration are requested.  The basis for any
regulatory action can be found by first reading the rationale for the action,
which follows the chosen option.   Further information, on the scientific basis
for an action, can be found by reading  the various  disciplinary chapters which
present sunmaries of available scientific data on the safety of
butoxicarboxime.

The data base on butoxicarboxime  was complete, to satisfy Agency requirements
for the registration of end-use butoxicarboxime products for  indoor,  non-food
uses.  Certain categories of data were  waived  because of the  nature of the
formulation (butoxicarboxime embedded between  two cardboard strips).   Agency
requirenents for che submission of efficacy data were also waived, because
butoxicarboxiroe is not registered  for any public health uses.   The currently
registered butoxicarboxime product meets  ail standards and conditions for
reregistration.

Proposed manufacturing-use products, intended  for reformulation into
insecticidal "pins", are acceptable under this Standard for indoor,  non food-
use applications.


 Description of_Chemical

Butoxicarboxime is a plant systemic insecticide used for the  control  of aphids
and two-spotted spider mites on potted  ornamental plants.   Butoxicarboxime  is
the common name for 3-(methylsulfonyl)-O-[(methylamino) carbonyl]  oxime-2-
butanone.  The Chemical Abstracts  Registry (CAS)  number for butoxicarboxime is
39196-18-4 and the EPA Shaughnessy Number is 113001.
                                      2-1

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There is no currently registered manufacturing-use  product.   The sole
registered product (registered on May 28,  1979)  is  an end-use product
containing 9.3% butoxicarboxime.  It is marketed  under the trade name Plant
Pin , and is formulated as a 8 mm X 40 mm  cardboard "pin".  The active
ingredient is sandwiched between two cardboard  strips.

 Regulatory Position

Butoxicarboxime (3-(methylsulfonyl)-O[(methylamino)  carbonyl]  oxime-2-
butanone), as described in this Standard,  may be  registered  for sale,
distribution, reformulation and use in the United States.   In preparing this
Standard, the Agency has considered the scientific  data obtained from the open
literature through April 1981, and data submitted by the registrant up through
the date of publication of the Standard.   Based on  a  review  of these data the
Agency finds that butoxicarboxime has neither met nor exceeded any of the risk
criteria found in section 162.11(a) of Title 40 of  the U.S.  Code of Federal
Regulations.  Therefore, the Agency has determined  that butoxicarboxime does
not cause unreasonable adverse effects to  either  man  or the  environment when
used in accordance with prescribed label directions and precautions.

Currently registered end-use products containing  butoxicarboxime as the sole
active ingredient may be reregistered under  this  Standard,  New end-use
products may be registered under this Standard, provided the proposed products
meet acceptable standards of product composition, use and toxicity as described
below.

Proposed manufacturing-use products may also be registered under this Standard,
provided the proposed product(s) meets acceptable standards  of product
composition, toxicity, and use.

 Regulatory Rationale

Butoxicarboxime is currently registered  for  indoor, domestic, non-food uses.
The only available end-use product is a 8  mm X  40 mm long "pin" containing 9.8%
active ingredient sandwiched between two cardboard  strips.  The "pin" is
inserted completely into the soil of houseplants  to systemically control aphids
and spider mites.

This chemical  is not currently registered  for outdoor or food uses.  The
formulation type and method of application are  not  expected  to result in
chronic exposure to man or the environment.  Therefore, only acute toxicity,
teratcgenicity and product chemistry data  are required to support the current
registration.

Proposed manufacturing-use products, intended  for reformulation into indoor,
non food-use insecticidal "pins" are acceptable under this Standard.  The
existing data  base supports the registration of such a product, provided that
the proposed product has been determined  to  be  the  same as the technical grade
                                       2-2

-------
of the active  ingredient.  Additional  acute toxicity data and product chemistry
information on  the  proposed manufacturing-use product would be required if the
Agency determines that  the proposed  manufacturing-use product is not the same
as the technical grade  of  the  active ingredient.

The Agency has  determined  that additional "generic" toxicology data, and
additional product  chemistry data  would be needed (on the technical grade of
the active ingredient)  for the registration of a manufacturing-use product
intended  for reformulation into an end-use product with a higher potential for
significant exposure, ie. a liquid or  spray formulations.

The Agency has  completed a thorough  review of the data en the safety of
butocarboxime and butoxicarboxime, and has concluded that the use of
butoxicarboxime will not result in unreasonable adverse effects to man or the
environment.  Available data included  acute dermal, primary eye irritation,
mutagenicity,  teratogenicity,  oncogenicity and reproduction testing of
technical grade butocarbcxiine;  acute inhalation testing of a 50% emulsifiable
concentrate containing  butocarboxime;  acute oral, neurotoxicity and 90-day
subchronic testing  of technical grade  butoxicarboxime; and acute oral, primary
eye irritation  and  28-day subchronic testing of formulated butoxicarboxime.
Butoxicarboxime, the active ingredient in Plant Pin , is a derivative of
butocarboxime.  In  plants and  animals, butocarboxime oxidizes to
butoxicarboxime.  Thus, available  acute and chronic testing of butocarboxime
will fulfill Agency testing requirements for testing of technical grade
butox icarbox ime.

The Agency's only concern regarding  the safety of end-use butoxicarbcxime
products  is that following application,  young children may be at risk through
accidental ingestion.   Following parental insertion of the "pins" into the
soil, young children may be tempted  to retrieve the "pins" from the soil of
houseplants.  For this  reason,  the Agency will not consider the registration of
end-use products for domestic  use  which fall into category I for acute oral
toxicity  under  this Standard (an amendment is required).  Registrants of end-
use products have the option of limiting the acute oral toxicity to categories
III and IV, or  of adding a proven  child repellent ingredient to products which
fall into category  II for acute oral toxicity.   These additives,  designed to
make the  "pin",  less palatable,  will  prevent the ingestion of fatal quantities
of butoxicarboxime  by children  and pets.
                                       2-3

-------
 Criteria for Registration Under  the Standard

lb be subject to this Standard, butoxicarboxime  products must:

    -  contain butoxicarboxime as the  sole  active ingredient;

    -  be within any established  standards  of  product composition;

    -  be within acceptable acute toxicity  limits;

    _  be labeled for acceptable  end-uses;  and

    _  bear required labeling.

The applicant for registration or reregistration of products under this
Standard must comply with all terms and conditions  described in this Standard
including a commitment to fill any data gaps in  accordance with the time
schedule specified by the Agency,  and  when  applicable offer to pay compensation
to the extent required under Section 3(c)(l)(D)  of  FIFEA, as amended, 7 U.S.C,
136(c)(l)(D).  As discussed in Chapter I, applicants for registration under
this Standard must contact the Agency  for specific  instructions, including
updated information on data and compensation requirements.

Because butoxicarboxime was initially  registered as a new active ingredient
after September 30, 1978, the sole registrant  (Wacker Chemie)  is entitled to
exclusive use of data generated for the registration of this product (FIFRA s.
3(c)(1)(D)(i)).  These data are entitled to a  10-year period of protection,
beginning on May 28, 1979.  During this period,  the Administrator may not grant
any application for registration  which relies  on the protected data unless the
original submitter of the data (Wacker Chemie  in this case)  has consented in
writing.
                                       2-4

-------
A.  Manufacturing-use Butoxicarboxime

1.  Acceptable Ranges and Limits

        a.  Product Conposition Standard

There is no currently registered manufacturing-use butoxicarboxime product.
Thus, there are no limits on product conposition  at this time.   Data are
required, however, on the physical and  chemical properties of technical grade
butoxicarboxime to support the registration of end-use  products.

Proposed manufacturing-use butoxicarboxime products are acceptable under this
Standard, with appropriate certification of limits.  The Agency must be
supplied with product composition, and  physical/chemical property data on
proposed manufacturing-use products which are not the same as the technical
grade of the active ingredient.

        b.  Acute Toxicity Limits

The Agency will consider registration of proposed manufacturing-use
butoxicarboxime products which have established acute toxicity  I-IV ratings for
each of the following effects:

                        Acute Oral Toxicity
                        Acute Dermal Toxicity
                        Acute Inhalation Toxicity
                        Primary Eye Irritation
                        Primary Dermal  Irritation

        c.  Use Patterns

To be covered under this Standard, proposed manufacturing-use butoxicarboxime
products must be labeled for formulation into end-use pesticides  intended for
indoor, non food-use applications.

The "generic" toxicology data base supports the registration  of any proposed
manufacturing-use product which is intended for reformulation into a particular
type of end-use product, ie. "pins" for insertion into  soil.  Additional
toxicology and product chemistry data on the technical  grade  of the active
ingredient may be required for the registration of a proposed manufacturing-use
product intended for reformulation into products  which  present  a  higher
potential for significant exposure.

Butoxicarboxime is currently registered for use only on indoor, ornamental
plants in the domestic (household) setting.

The Agency will consider a non-domestic, indoor use  (ie.  greenhouse use)  under
this Standard provided any additional data required  to  support  the non-domestic
                                      2-5

-------
use (additional data on physical/chemical properties)  are  submitted,  found to
be adequate, and do not indicate that  the use  pattern  will result in  any
unreasonable adverse effects to applicators.

This Standard must be amended to register butoxicarboxime  for outdoor and/or
food-use applications.  Additional product  safety data in  the areas of
environmental fate, ecological effects,  toxicology,  and residue chemistry are
needed for the registration of butoxicarboxime for outdoor and/or food uses.
Refer to process for submission of amendments  on page  1-6.


2.   Required Labeling

All proposed manufacturing-use products  must bear appropriate labeling as
specified in 40 CFR 162.10.

3.   Tolerance Reassessment

Current use patterns do not require tolerances or exemptions from tolerances.
                                       2-6

-------
3.  End-Use Butoxicarboxime

1.   Acceptable Ranges and Limits

        a.  Product Composition Standard

Currently registered butoxicarboxime  is  formulated as a 8  nm X 40 mm cardboard
"pin", containing 9.8% active  ingredient  imbedded  between  two cardboard
strips.  End-use butoxicarboxime products containing any percentage of active
ingredient are acceptable (with appropriate  certification  of limits) under this
Standard.

The Agency will allow any percentage  of  active  ingredient  because acute
toxicity testing of technical grade butoxicarboxirae (containing 94-96%
butoxicarboxime) indicates no greater than moderate acute  toxicity.

        b.  Acute Toxicity Limits

Because of the limited potential for  human exposure or adverse ecological
effects through the indoor, domestic  use  of  products containing
butoxicarboxime, the Agency will consider end-use  products in the following
toxicity categories:

                               I            II        III       IV

Acute oral toxicity          Amendment    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


End-use butoxicarboxime products formulated  and applied in a substantially
similar manner to the currently registered product (i.e. active ingredient
imbedded in non-toxic material and pushed into  the soil of ornamental plants)
are acceptable with category I-IV ratings for acute dermal toxicity, acute
inhalation toxicity and primary eye and primary dermal irritation.  The Agency
has determined that categories I-IV are acceptable for (general)  domestic use
because the formulation type and method of use  can be reasonably expected to
eliminate the routes of exposure.

*  End-use butoxicarboxime products with  category  III-IV ratings for acute oral
toxicity are acceptable for domestic  use  under  this Standard.   The Agency has
determined that products with an acute oral  toxicity rating in category II are
also acceptable for registration under this  Standard provided  registrants add a
proven child repellent ingredient.  This  option has been selected because the
Agency is concerned about the possibility of young children ingesting
butoxicarboxime following application.
                                       2-7

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

To be registered under this Standard, butoxicarboxime products may only be used
indoors, on non food-use crops.

 Additional Uses

Butoxicarboxime is currently registered  for  indoor,  domestic, non-food uses.
Products can be registered for non-domestic  use  under this Standard provided
any additional required data (physical/chemical  properties of technical grade
butoxicarboxime) are submitted and  found  to be adequate.

Butoxicarboxime products cannot be  registered  for outdoor uses or for food-uses
under this Standard because of the  lack of environmental  fate, ecological
effects data and established tolerances.  An amendment to this Standard is
required for the registration of these uses.


2.  Required Labeling

All end-use products containing butoxicarboxime  must display appropriate
labeling as specified in 40 CFR 162.10.   The guidance package that accompanies
this Standard contains specific information regarding label requirements.
                                       2-8

-------
                                  CHAPTER III


                        DATA REQUIREMENTS AND DATA GAPS

A.  Generic Data Requirements and Data Gaps

Table A, entitled:  "GENERIC DATA REQUIREMENTS:  BUTOXICARBOXIME",  includes those
data that pertain to the properties or effects of butoxicarboxime as an active
ingredient.  Thus,  these data are relevant to an evaluation of the risks and
benefits of all products containing butoxicarboxime.   Providing data to fill
indicated gaps in the data base is the priinary responsibility of  the
manufacturing-use product registrant(s).   Because there is no currently
registered manufacturing-use butoxicarboxime  product,  any needed  data must be
provided by the registrant of the sole registered end-use product to obtain
reregistration.

Wacker Chemie, the  sole registrant of  butoxicarboxime  products, is entitled to
exclusive use of these data for a ten  year period,  starting on September 30,
1978 (FIFRA s. 3{c)(1)(D)(i)).  These  data may not be  used to support any
application for registration without the  written permission of Wacker Chemie.

                            Product Chemistry Data

Certain data on the physical/chemical  properties of technical grade
butoxicarboxime are required for the registration of any product  containing
butoxicarboxime as  the sole active ingredient.

                                Toxicology Data

The potential for chronic exposure to  butoxicarboxime,  or to residues of
butoxicarboxime is  low because of the  use pattern (non-food use), and the
unique type of formulation and method  of  application.   The Agency has
determined that acute oral toxicity testing,  acute  dermal toxicity testing,
acute inhalation toxicity testing, acute  delayed neurotoxicity testing,  and
teratcgenicity testing (in one species) on the technical grade of the active
ingredient are the only toxicology data requirements for the registration of
butoxicarboxime for domestic, indoor,  non-food uses.

         Environmental Fate, Residue Chemistry,  and Ecological Effects

The currently registered end-use butoxicarboxime product is not registered for
outdoor or food uses.  Environmental fate data,  residue chemistry data,  and
ecological effects data are not required  to support current uses.
B.  Product-Specific Data Requirements  and  Data  Gaps:  Manufacturing-use
Products

Table B, entitled: "PRODUCT-SPECIFIC DATA REQUIREMENTS:  MANUFACTURING-USE
BUTOXICARBOXIME", includes those data which are  required for the registration
of a proposed manufacturing-use product under  this  Standard (for domestic/non
domestic indoor non-food uses).
                                      3-1

-------
                            Product Chemistry  Data

Certain data on the composition aand physical/chemical  properties of any
proposed manufacturing-use product are  required  if the  proposed product is not
equivalent to the technical grade of the  active  ingredient.

                                Toxicology  Data

Acute toxicity data on the proposed manufacturing-use product may be required
if the proposed manufacturing-use product is not toxicolcgically equivalent to
the technical grade of the active ingredient.


C.  Product Specific Data Requirements  and  Data  Gaps: End-Use Products

Table C, entitled: "PRODUCT SPECIFIC DATA REQUIREMENTS:  END-USE
BUTOXICARBOXIME'1 includes those data that relate only to the properties or
effects of an end-use product with a specific  composition.   Thus, these data
are required to support the registration(s) of each end-use  product with a
specific composition.  Providing data to  fill  these requirements is the
reponsibility of each applicant for the registration of an end-use product.

Applicants for the registration of new  end-use butoxicarboxime products must
submit all product-specific data or establish  that the  proposed product is
substantially similar to another product  for which the  Agency has received
acceptable product-specific data.

                            Product Chemistry  Data

Because end-use butoxicarboxime is formulated  as "pin"  for  insertion into soil,
data on the physical/chemical properties  of technical grade  butoxicarboxime
will provide sufficient information for the registration of  the sole end-use
product for domestic use.  Additional data  on  the physical/chemical properties
of technical grade butoxicarboxime are  required  for the registration of this
active ingredient for non domestic (greenhouse)  uses.

                                Toxicology  Data

The only data required on the currently registered end-use product is acute
oral toxicity testing, and primary eye  irritation testing.   These data are
required because of the potential for accidental ingestion of end-use
butoxicarboxime by young children following "application".   Eye irritation
testing is required because of the possibility of homeowners transferring
residues of butoxicarboxime into the eyes following application.  Data provided
on the acute dermal toxicity of technical grade  butoxicarboxime fulfill Agency
requirements for this category of testing.

Although acute inhalation toxicity testing  of  technical grade butoxicarboxime
was available, these data are not required  for the registration of this end-use
product.

Primary dermal irritation testing was not available for either technical grade
butoxicarboxime or the currently registered end-use product.   These data are
not required.
                                       3-2

-------
                                                                              TABLE-A: BI/IOXICAKBOXIME
                                                               GENERIC IOTA REGUIRENENTTS: PROnUCT CHEMISTRY
UJ
Guide] ine
Citation
Name of Are Data Test
Test Required? Substance
Does RPA Have Data to Bibliographic
Partially or Totally Citation
Satisfy Requirement?
Must Wditional Data be Suljnittetl
under FIFRA 3(c)(2)(B)? ttjnth
and Year rnla Cue.
PRODUCT CHEMISTRY
163.
163.
163.
163.
163.
163.
163.
163.
61-3 (b)
61-8(1)
61-8(2)
61-8(3)
61-8(4)
61-8(5)
61-8(7)
61-8(10)
Identification
Color
Odor
Malting Point
Solubility
Stability
Fhyslcal State
\&por Pressure
Yes
Yes
Yes
Yes
Yes
Yes
*s
M2S
Tech.
Tech.
Tech.
Tech.
Tech.
Tech.
Tech.
Tech .
Grade*
Grade
Grade
Grade
Grade
Grade
Grade
Grade
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Wicker
Wacker
Wacker
Wacker
Wacker
Ghent ie,
Cheinie,
Chcmie,
Cheinie,
OiemiG,
Braunling, 1976
Br aim ling, 1974
Wacker
Wacker
Cheinie,
Giemie ,
1974,
1974,
1973,
1974,
1974,
GS 0077031
O3 0077031
GS 0077031
GS 0077031
G3 0077031
, G30077006
, QS007705
1974,
1974,
03 0077031
050077031
No
No
No
No
Ho
No
No
NO
         Data Ifequirements Current
         as of /Vgust 1981.  Refer to
         Guidance Package for any new
         Requirements after this date.
              * Technical Qrade Butoxicarboxjme

-------
                                                                  TAIHE-A  (con): Bt/TOXICARBQXIMB
                                                      GENERIC HftTA REQUIREMENTS: TOXICOLOGY
Guideline
Ci tation
TOXICOtjOGY
163.81-1
163.81-2
163.81-3
J63.B1-7
163.82-1

Uj 163.83-1
1
4=7 163.83-2
163.83-3
163.83-4
163.84-1-4
163.85-1
Name of Test
Test

Acute Oral
Toxicity
Acute Dermal
Toxic ity
Acute Inhalatior
Acute Delayed
Naurotoxicity
Subchronic Oral
Toxicity
(21-day) Dermal
Chronic fteeding
Oncogen ic ity
Teratogenicity
Keproduction
Ritagenicity
Metabolism
Are Data
Required?

Yes
Yes
i Yes
Yes

Tbxicity
to
NO
Yes
No
No
No
Test
Substance

Technical*
Technical
Technical
Technical
Technical

Technical
Technical
Technical
Technical
Teclmical
Does EPA (lave Cat a to
Partially or 'totally
Satisfy Requirement?

Yes
Yes
Yes
Yes
Yes1

Partial
Partial1
Yes
Yes1
Partial
Bibliographic Must Mditional teta be Subrai
Citation under FIFRA 3(c)(2)(B)? Mantl
and Year cata die.

Zipf, 1971, QS0077045 No
Zipf, 1971, 030077043
Huisnans and Williams, 1972, G30077010 Mo
Kruysse, 1973, QS0077012 No
Ross et al., 1977, GB0077018 No
(Til, 1973, CB0077024] No
ISinkeldam, 1974, O30077019]

(Til et al., 1977, QS0077023) No
[Til et al., 1977, GS0077023) No
Koeter, 197S, QS0077011 No2
I Til et a 1., 1977, GS0077025) No
IWUleros, 1977, G30077042] No
Data Itquirements Oarrent as of
August, 1981.  Refer to Guidance
Package for any new Fbquiranent s
after this date.
*  Technical Grade Uutoxicarboxiine or technical grade butocarbox 'me.
[  ]- Available data on butocarboxirae.

1- AHhoujh data are not required on this topic for the current registration, sane data on this topic were available for
   review.  Additional testing is not required.

2- Because the results of the submitted study indicates no adverse effects, and because significant exposure is not anticipated
   additional testing is not required.

-------
                                                                     TAIHJ; »: IllJi
                                                         si'ix:iKic IKI-A  iu)uuci-.;
CltiltiOl
tin*-- ot" Are liita 'l\.-st Ux-s KPA Itovo Dita to niblioqrciphic Must Atlditioial ruta li: Uubinittod
'iV'St iv.- Subdtaice Partially or Totally Cttatioi uider l-'Ii-'i Poxluct1 tockui- Uicmiu, 1974, asi)0'//U3l
uul Disclosure- of
Iiiyroditnts
U.'£ii:ription ot Yes Eadi Pro-Juct Mu.'ller ct ., liadi Product
J63.61-8I11) |)ll
163.61-8(12) ytorayc  Stab.

163.61-8(13) Kloinnobility
163.61-8(14) Oxidizing  or
                     iq Act 101
                                             xidi  Product
                                            Eadi  Product
                                                  Product
                                                  Product
16'J.61-8( 15) lixplosivcjioss

163.61-0(16) Misoibility

163.61-8(17) Viscosity

163.61  8(18) Corrosiai
              O iu r. ic t«_: r i s 11 ca
                                                  IVoiJuct
                                                  Product

                                     It)
                                     No
                                            Ejd>  Praiuct
                                            Eadi  ProcJuct
luta  ix.'|uivaluit  lo the todnicdl gr.uk:  of.  tin.- active mgrudiuit.

2-  Uit.a  have  l>.-(n suUnitted 01   the U.-d«>ical gcad.; ot  the active.  Iliui 01  t;lie  HUP must te submitted £it t)>e  till*.-
    th.it  ^i(v' icatun tor ix-f|istfjtim is irudc.

J-  lut.i  aiv not u:
-------
                                                                  TADl£-n: UUKJX1CAJUJOXIME
                                                pnDttlCT-SPH,lflC  tVVI'A KUOUlRETlHfrS: PIOPOSEP M'iNUFACmRINC-USi: PKUXICI'o
Guideline
Citatioi
TOXICOLOGY

1 (; -> QI o
\ft \ Rl ")
163 81 4
163.81-5
LO
1
time of Are Data Ibst
Ibst fequirod? Substau^e


itoxicity
Itoxicity
lioxicity
Irritatioi
Pt'iinac-y Dermal No
IcritaLioi
DDGS KPA Have Data to Uiblioqra|Jhic Must Aj SutanitLcd
Partially or 'totally Citation mcfcr P1H«V J(c)(2)(U)? Mcnth
Satisfy RKiuirumfcnt? /nil year data duo.






liita IJits arc current  as  of
August,  1981.   Refer to Guidaioe
Package  for  aiy new R_>quireii»:n ts
after this date.

)- Itesting en  the mnuf.ieturing--use product  is  required if ttie proposed product is not  toxicoloqic.illy ccjuivaluit
   to the  technical griide of the  active ingredient.
2- Au«iilable data are en tcdiiical  grade of  the  active ingredient.
3- 'U;sting  is  not required because  of Jow potential  for oxfxasutt; to end-use prouct.

-------
                                                                        TAJIU:
                                                                      H.TA
                                                                                                 :ii;  IIIIUK.VJ
                                                                                   Cr CIIWII.ITKY
                                 Art.-
                                              •iX-SL
                                              SuttiUiure
I6J.61-J
lbl.M-4      U:SCfiiiLioi  ot        Yes
               Mnuf^ictuirijuj
               Disc, of  Fornuil. im    Yes     liwji  l>rx*liict
              at  lii<]f<.-(li(jic Id

16J.6I-7     1'io.luct Auilyl.
lbi.OI-U(7)  H.ydieul lit

IGi.bl-U(U)  IXnaU.y c«
                                                           , 1
                                      Yea     K«J\
                                                                 f\X-3 KI'A ILiVc liltj  to
                                                                 Kjrtially ot  'lUColly
                                                                 SoLisly rt.ijuii-uiikiiL?*
                                                 Ilibl loiu
                                                 ClLal IOI
Must  Afjftioijl tJut.i  iJu'sitlanu'Cirif
uuljt  t-'inui  J(c)l^) (ll| .' Maitu
titil yj.
                                              liidi  1'iOJuct1    Yes
                                                    IVoJm-.l
                                                                 Yos
Cull  Puxluct      Yi:s


              I
                                              Q\d-usc- l>ioJiK:t.
                                                                 It,
                                                                                             <.icU;i- Uwmio,  1974, uxurntm
                                                                                            Mvulluc i:l  ul.,  1'J70, l!L»07
                                                                                               Iti^tu-a- Oic-uuu,  19VV, Iii0077()lll

                                                                                            ttockuir Uicmic,  I'J74, CiiOHTi
                                                                                                    QuiBlu,  !!*'»*.  Cl!0l)77llil     1111


                                                                                            Mlu.-b.-r Uiumic,  1970.  oa)i)77Ja      l)u '
                                                                                              Uci>u\lm>],  19V1,  tt>0077U02

                                                                                              Mtukuf Owwic,  l'J74, «i007701l     Ito1
16J.61-U(1U)
lG1.6l-B(lt) P

IGj-dl-UI IS)  t:xi>losivuti:us

IbJ.l.l Utlb)  Misclbiluy
 Ib.i.(>1-U( IB)  Coinxjicn
               Uui.ict' rii.1 ics
                                            'IL-aiilCMl
                                            'IV.1H1 I
                                      Ib
                   Yus
                   (to
                   Yus
                   Ib




                    tk>

                    Ib

                    (U
                                                                                                      umic, 1iUU77UjJ     lie

                                                                                                       .  l'J76, UA)IJ77UUfa          (Ju
                                                                                                         ,  1U74,  IU0077005
   ot  Aujusl,  1981.   l  uo t\:gnit.«*ii.tJ  ninutairturcuj-ii^o  |>totiu:i. iiituLuwtt. iui  td
     illll UH:  ft *<.J i moi't >.! ttu) -11^: |>fuluCL.
                                                                                               en IAJLJI
     Hit. i : ot  lot iiitil.iiim . in^tltfAl ot  :t|Jt)l icdLiui cn<)  use (Aittirtn.  lut«i
     I i t;i:.t !%>(. JO)  Ot  vi lUJt  »Kll> ^t 1C  (»t  U«.: nxjiatralic i  ot oily UIL-  cufruitly rixjiiitutvil o>il-ua« |«'i»l(«:L.   /\n  ii>-w  protiict:*  (iiti^t sutinii 
-------
CO

oo
                                                                       TABLE-C: BtrrOXICARBOXlME
                                                     PRODUCT-SPECIFIC DATA REQUIKEMENTS:  END-USE PRODUCTS
                                                                                TCHQCCkCGY
Guideline
Citation
TOXICOU3GY
163.81-1

163.81-2

163.81-3

163.81-4

163.81-5
Name of Are Data Itest Does EFA (lave tota to Bibliographic Must Additional Data be Submitted
Test Required? Substance Partially or Totally Citation under FIFRA 3(c)(2)(B)? Itonth
Satisfy Requirement?* and Year Data Cue.

Acute Oral Yes
Tbxicity
Acute Dennal tb
Toxic ity
Acute Inhal . l>b
Tbxicity
Prim. Eye Yes
Irritation
Prljnary Dennal to

Extract o£ Yes
"Pin"**
Technical Yes

Technical Yes

Extract of Yes
"Pin"**


Til et al., 1977, G30077022 No

Huisman & Williams, 1972, G30077010 No

Kruysse, 1973, GS0077012 No

Van Bsek, 1977, G30077027 No


                      Irritation
        Data requirements are current as of
        August,  1981.   Jtefer  to Guidance
        Package  for any new Requirements
        after this  date.
        *    Fbr currently Registered  Product.
        **   Testing o£ extract  from actual end-use product  is required.
        1- Testing on the end-use  product  is  not  required.  Available data on  the  technical grade of  the active  ingredient will suffice.

        2- Testing is not required because of the 1 united potential  for exposure.

-------
                                  CHAPTER IV



                      PRODUCT  CHEMISTRY  OF BOTOXICARBOXIME


             Product Chemistry; Manufacturing-use Butoxicarboxime


                           Prcduct Chemistry Profile

Butoxicarboxime  is the canmon  name  (accepted by the British Standards
Institution and  the International Organization  for Standardization)  for O-
[(methyl-amino)  carfconyl] oxime 3-(methyl-sulfonyl)-2-butanone.   The .American
National Standards Institute  (ANSI) does not recognize "butoxicarboxime" as the
canmon name.  However, "butoxicarboxime" will be used throughout this Standard
in lieu of the longer chemical name.

In early phases  of development, butoxicarboxime was referred to as Wac 85940S.
Other synonyms include butoxicarboxiin, Co. 859,  and butoxycarboxime.  The
Chemical Abstracts Registry Number  (CAS  Number)  for O-[(methyl-amino) carbonyi]
oxime 3-(methyl-sulfonyl)-2-butanone  is  39196-18-4.  The EPA Shaughnessy Number
is 113001.  Henley + Co.  Inc.  is the  sole domestic distributor of the only
registered product, marketed  under  the trade name Plant Pin and produced by
Wacker Chemie of West Germany.

The chamical formula is GyH^N-O^S, and  the molecular weight is 222.
The structural formula is:
                    H      CH3                      OK
                                                           N	CH3
Technical grade butoxicarboxime  contains  a minimum of 94-96%  0-[(methyi-amino)
carbonyl] oxiroe 3-(methyl-sulfonyl)-2-butanone.   Butoxicarboxime is a colorless
crystalline solid with a melting point of 85-89  C,  and a vapor pressure of 2
x 10~° rog Hg at 20 C  (Wacker  Chemie,  1974, GS0077031).  Butoxicarboxime has
a slightly pungent odor.  Butoxicarboxine is  50% soluble in water,  readily
soluble  in chloroform, acetone,  methanol, and ethanol, and almost insoluble in
petroleum and carbon  tetrachloride  (Wacker Chemie,  1974, GS0077031).
Butoxicarboxime, formulated as an end-use product,  is stable for up to 5 years
(Braunling, 1976, GS0077006;  Braunling, 1974,  GS007705).

A detailed description of the manufacturing process for technical grade
butoxicarboxime was available (Mueller et al., 1970,  GS0077015).  The
manufacturing process cannot  be  described in  this Standard because this
information is considered to  be  confidential  business information.   The
manufacturing process, as submitted by Wacker Chemie, is adequate to satisfy
Agency requirements.
                                      4-1

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Wacker Chemie has also submitted a confidential  statement  of  ingredients
contained in technical grade butoxicarboxime  (Wacker  Chemie,  1974,  GS0077031).
Submitted data are adequate to satisfy Agency requirements.

An adequate analytical method for the identification  and quantification of
butoxicarboxime in end-use products has been submitted  (Wacker Chemie,  1976,
GS0077038).  According to this method, a  suitable  amount of  sample  is weighed
and then dissolved in chloroform.  An appropriate  amount of
octamethyltetrasiloxane  (CMS) is added to the solution, and  then the NMR
spectrum is determined.  The amount of butoxicarboxime  is  quantified through
calculations derived from the spectrum.   Sufficient data,  generated from the
application of the method described above, have  been  provided to fulfill Agency
requirements (Braunling, 1973, GS007702).

Data generated to fulfill data requirements for  the physical/chemical
properties of technical grade butoxicarboxime will satisfy Agency requirements
for this type of data on end-use butoxicarboxime (formulated  as a "pin" for
insertion into soil).
                                       4-2

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 Product Chemistry: End-use Formulations
                           Product Chemistry Profile

The sole registered end-use butoxicarboxime  product is  a 9.8%  (by weight)
"pin".  A butoxicarboxime  "pin" contains  butoxicarboxime wedged between two
8 mm X 40 run cardboard strips, which are  glued  together.   The  currently
registered end-use product contains an  intentionally  added child repellant
ingredient.  This ingredient is added to  decrease  the likelihood of the
accidental ingestion of fatal quantities  of  butoxicarboxime by young children.

Available data on the identity and quantities of inert  ingredients in the
currently registered end-use product are  sufficiently detailed to fulfill
Agency requirements.  The description of  the manufacturing process, provided to
the Agency by Wacker Chemie (1976, GS0077038),  is  also  adequate.

Data on the physical/chemical properties  of  the formulation used to make
butoxicarboxime "pins" are not specifically  required.  Data generated en
technical grade butoxicarboxime provide sufficient information.

Data are not required for Sections 163.61-8(8)-(18) because of the type of
registered end-use formulation and method of application.   These data would be
required to support non domestic, outdoor or food  uses.
                                      4-3

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                                   CHAPTER V
                     ENVIRONMENTAL FATE OF  BUTOXICARBCXIME
                              Use Pactem Profile

Butpxicarboxime is a systemic plant  insecticide  registered  for the control of
aphids and two-spotted spider mites  on potted  ornamental  plants.
Butoxicarboxime is formulated as a 9.8% cardboard  "pin".  The  "pin"  is pushed
completely into the soil of a potted plant  approximately  one inch from the
plant stem.  Butoxicarboxime is released by moisture  in the soil  and absorbed
by the roots of the plant.  Following absorption,  butoxicarboxime is
translocated into the plant.
                          Environmental  Fate  Profile

The sole registered product containing butoxicarboxime  as  an active ingredient
is an end-use product currently registered  for  indoor uses only.   Although data
on the physico-chemical degradation, mobility,  and metabolism of
butoxicarboxime are not currently required  for  registration, some information
is available.

Wacker Chemie (Braunling 1973, GS0077003) reported to the  Agency  that
butoxicarboxime does not hydrolyze or photodegrade under normal environmental
conditions.  In one study, 52.1 mg of butoxicarboxime (formulated as a "pin")
was placed in the soil of a potted plant.   The  soil was analyzed  for residues
of butoxicarboxime by GLC.  At 91 days,  only  0.23 mg  of butoxicarboxime
remained (Braunling 1973, GS0077003).  Submitted data suggest a half-life in
soil of approximately 50-60 days.

Greenhouse testing shows that more than  90% of  butoxicarboxime diffuses out of
the cardboard "pins" within two days of  application  (Braunling 1973, GS0077003).
                               Exposure  Profile

Butoxicarboxime is a non-volatile systemic  insecticide  which is not currently
registered for outdoor or food uses.  The Agency does not  anticipate that
significant exposure of either man or his environment to butoxicarboxime will
occur from the use of butoxicarboxime in houseplants.

The Agency has identified the possibilities of  accidental  ingestion of
butoxicarboxime by children, and accidental ocular exposure (through touching
of exposed hands to eyes) as potential routes of exposure.
                                      5-1

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                                  CHAPTER VI
                         TOXICOLCGY OF BUTOXICARBOXIME
Introduction

The first section of this chapter discusses  the  toxicity of butoxicarboxime as
an active ingredient.  The data discussed here pertain  to the  properties of
butoxicarboxime•as an active ingredient, and are  relevant to an  evaluation of
the risks of all products containing this active  ingredient.   This  type  of data
is referred to as "generic" data.

The second section of '•his chapter discusses the  toxicity of the sole •
registered end-use product containing butoxicarboxime.

Wacker Chemie  (the sole registrant) markets  an  insecticide for use  on
agricultural crops in countries outside  the  United  States.   The  active
ingredient in  this insecticide is butocarboxime  (3-(methylthio)-O-
[(methylamino) carbonyl^ oxime-2-butanone.   Bu toxi carboxime, the  active
ingredient in Plant Pin , is a derivative of butocarboxime.   In  plants and
animals, butocarboxime oxidizes to butoxicarboxime.  Thus,  available  acute and
chronic testing of butocarboxime will fulfill Agency testing requirements for
testing of technical grade butoxicarboxime.

Acute dermal and inhalation toxicity testing of  technical grade  butocarboxime
or butoxicarboxime will provide sufficient data to  support the registration of
the currently registered end-use product.  Acute  oral toxicity testing and
primary eye irritation testing of extracts of the currently registered end-use
product is required.  These data were available  for review,  and  satisfied
Agency requirements.
                                      6-1

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A.   Manufacturing-use Butoxicarhoxjjne

As discussed in chapter II, there  is no  currently registered manufacturing-use
butoxicarboxime product.  However, acute oral,  dermal,  and inhalation toxicity
data, acute delayed neurotoxicity  data,  and  teratogenicity data on technical
grade butoxicarboxime (or technical grade  butocarboxime)  are required for the
registration of end-use products.

Although the use pattern and method of application indicate that chronic
exposure to butoxicarboxime is unlikely, a substantial  quantity of both acute
and long term toxicity testing of  butocarboxime (and  butoxicarboxime) was
available for review.  Presumably, these data were needed for the registration
of butocarboxime abroad for use on agricultural crops.


                              Toxicology Profile

Acute Toxicity

Single dose oral toxicity testing  of technical  grade  butoxicarboxime (94-96%
pure) in rats and rabbits suggest  moderate acute oral toxicity.  The LD50 in
rabbits is 275 mgAg  (Zipf, 1971,  GS0077045), and the LD50 in rats is 458 tngAg
(Zipf, 1971, GS0077043).  The reported acute oral LD50  values place technical
grade butoxicarboxime in Category  II for acute  oral toxicity.

An acute dermal LD50 value of 360  mgAg  for  technical grade butocarboxime in
albino rabbits was established (Huismans and Williams,  1972, GS0077010).  This
value suggests a moderate (Category II)  acute dermal  toxicity.

The acute intraperitoneal toxicity of an extract of end-use butoxicarboxime was
determined in albino rats (Zipf, 1971, GS0077044).  The reported LD50 was 220
mg/kg body weight.  Signs of.toxicity included  tremors and diarrhea.

In acute inhalation toxicity testing, an LC50 value of greater than 4.6 mg/L in
albino rats was established for a  50% emulsifiable concentrate containing
butocarboxime as the active ingredient  (Kruysse, 1973,  0077012).

Eye irritation testing of technical grade  butocarboxime in albino rabbits
indicated that this substance is a severe  irritant (Category I), inducing
corneal lesions and irreversible  (longer than 7 days) conjunctivitis (Huismans
& Williams, 1972, GS0077010).  It  is thought that butocarboxime is more
irritating to eyes than butoxicarboxime  because of differences in water
solubility, with butoxicarboxime being more  water soluble and therefore more
easily rinsed from the eye through the natural  tearing process.

Neurotoxicity testing of technical grade butoxicarboxime in domestic hens
indicated no delayed neurotoxic effects  at dosages up to 367 mgAg (Ross et
al., 1977, GS0077018).


Subchronic Tqxicity

The subchronic (28-day) toxicity of extracts of end-use butoxicarboxime to
albino rats was evaluated in a 28-day range-finding study (Til, 1973,
GS0077024).  Rats were fed a preparation derived from end-use butoxicarboxime.


                                      6-2

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Diets contained 300, 1,000, qnd 3,000 pern of  the  active  ingredient
(butoxicarboxime).  The No Observable Effect  Level  (NOEL)  of butoxicarboxime
was 300 ppm for cholinesterase depression.

The subchronic  (90-day) toxicity of  technical grade  butoxicarboxime was
evaluated in a study utilizing albino rats as the test species  (Sinkeldara,
1974, GS0077019).  The test material  (technical grade butoxicarboxime)  was
administered at dietary levels of 0, 100, 300, and 1,000 ppra.   The No
Observable Effect Level (NOEL) for technical  grade butoxicarboxime was  300 ppm
or 15 mgAg body weight.  A decrease in body  weight  and  in red  blood cell and
brain cholinesterase levels occurred at dietary concentrations  of 1,000 ppm.


Chronic Toxicity

Teratogenicity

Teratogenicity testing of technical grade butocarboxime  in rats demonstrated
that butocarboxime does not induce adverse effects on fetuses at maternal
dietary levels up to 600 ppm on days 6-15 of  gestation  (Koeter, 1975,
GS0077011).

3-Generation Reproduction

At 300 ppm dietary levels, technical grade butocarboxime slightly
decreased(less than 10%) red blood cell cholinesterase levels,  and slightly
increased liver weights in female rats.  A No Observable Effect Level (NOEL) of
100 ppm for this effect was established.  No  other adverse effects were
reported (Til et al, 1977, GS0077025).

Mutagenicity

The mutagenic activity of technical grade butocarboxime  was examined in the
Salmonella/microscme mutagenicity test.  Reported results  did not indicate that
butocarboxime is mutagenic (Willems, 1977, GS0077042).

Chronic Feeding/Oncogenicity

General condition, behavior, survival, growth, and histopathology were  not
adversely affected at any dietary level (30,  100  or  300  ppm) of technical grade
butocarboxime in rats.  Cncogenic potential was negative.   Plasma and red blood
cell cholinesterase levels were decreased at  300  ppm.  The No Observable Effect
Level (NOEL) reported in this study, for plasma and  red  blood cell
cholinesterase depression was 100 ppm (Til et al, 1977,  GS0077023).
                                       6-3

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B.  End-use Butoxicarfaoxime

Acute oral toxicity testing and primary  eye  irritation testing of extracts of
end-use butoxicarboxime are required  for the  registration of this particular
type of formulation (butoxicarboxime  impregnated  between two cardboard
strips).  Submitted data were reviewed and found  to be acceptable.   Other
categories of acute toxicity testing  of  end-use butoxicarboxime (acute dermal
toxicity, acute inhalation toxicity,  and primary  dermal irritation)  are not
currently needed because exposure  through these routes is not expected to be
significant, and available data on technical  grade  butocarboxime and
butoxicarboxime indicate low to moderate toxicity.

Data generated on technical grade butocarboxime or  technical grade
butoxicarboxime are relevant to the hazard evaluation  of the end-use product.


Acute Toxicity

The acute oral LD50 of extracts from  formulated butoxicarboxime (containing
9,8% butoxicarboxime) is greater than 5  gmsAg  body weight in rats (Til et al.,
1977, GS0077022).  This places the currently-registered end-use product in
Category IV for acute oral toxicity.

Primary eye irritation testing of extracts from formulated butoxicarboxime
(containing 9.8% butoxicarboxime)  indicates moderate to low (Category II)
irritability in rabbits (Van Seek, 1977, GS0077027).
                                       6-4

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                                  CHAPTER VII
                               RESIDUE  CHEMISTRY
Butoxicarboxime is not currently registered for agricultural uses.

For future registration of a butoxicarboxiire product for use on a feed or feed
crop, the Agency must be provided with  a petition for tolerance, a full range
of data including a validated method  for analysis of residues in or on the raw
agricultural commodity, data on metabolism  in plants and animals (when
appropriate), and residue data reflecting the proposed use of butoxicarboxime
on the crop.
                                       7-1

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                                 CHAPTER VIII
                     ECOLOGICAL  EFFECTS  OF BUTOXICARBOXIME
Butoxicarboxime is not currently registered  for outdoor uses.

Although data on avian and aquatic  toxicity  are not currently required for
the registration of an indoor use product, sane information is available.
Wacker Chemie (Mann, 1974, GS0077013) reported  to the Agency that the LCSO for
rainbow trout is 38 mg/L for technical  grade butocarboxime, indicating that
technical grade butocarboxiine is only slightly  toxic to rainbow trout.  The
LCSO of butocarboxime to Idus idus  melantotus was also reported in this study.
The reported LCSO was 56 mg/L.

Butoxicarboxiine was tested for  its  toxicity  to  guppies.  The LCSO was
determined to be 70 mg/L (Wacker Chemie,  1972,  GS0077029).   The LCSO of
butocarboxime in Japanese quail was determined  to be 1180 ppra (with 95%
confidence limits of 1009 ppm and 1381  ppm)  (Til, 1974, GS0077025).  This
indicates that technical grade  butocarboxime is only slightly toxic to Japanese
quail.

For the registration of an outdoor  use  product, the data discussed above must
be reviewed and a hazard assessment must  be  completed (if the data are
determined to satisfy Agency requirements).
                                       8-1

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                           rv   r.'^-1 3T~r "
                           *.*» •  ^-* J^M _i j : .. •

                       Guide to Use of This  Bibliography


i.  Content of Bibliography.  This bibliography contains citations of all the
    studies reviewed by EPA  in arriving at  the positions and conclusions stated
    elsewhere in this standard. 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 o_f Entry.  The 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 frcm within the  typically larger volumes in which they
    were submitted.  The 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.  The Agency
    has attempted also to unite basic documents and commentaries upon them,
    treating them as a single study.

3.  Identification of Entries.  The entries  in this bibliography are sorted
    by author, date of the document, and  title.  Each  entry bears, to the Isft
    of the citation proper,  a nine-digit  numeric identifier.  This number is
    unique to the citations and should be used at any  tiire specific reference
    is required.  This number is called the  "Vaster Record Identifier" or
    "WRID".  It is not related to the  six-digit "Accession Number", which has
    been used to identify volumes of submitted data; see paragraph 4(d)(4)
    below for a further explanation.   In  a  fev; cases,  entries added to the
    bibliography late in the review may be  preceded by a nine-character
    temporary identifier.  This 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.   The bibliographic
    conventions used reflect the standards of the American "aticnal Standards
    Institute (ANSI), expanded to provide for certain  special needs.  Scr.e
    explanatory rotes 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.

    b.   Document Date.  When the date appears as four digits with no
         question mar.ks, the Agency took  it  directly from the document.  When a
         four-digit date is  followed by a question mark, the bibliographer
         deduced the r*ate from evidence  in  the document.  When the date appears
         as (19??), the Agency was unable to determine or estimate the date of
         the document.
                                        9-1

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c.   Title.  This is the third element  in  the  citation.   In  seme cases it
     has been necessary for .Agency bibliographers  to  create  or enhance a
     doc-orient 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
     submissions:
     (1)  Submission Date.  Immediately  following  the
          appears the date of the earliest known submission,  at the time
          that particular document was processed into  the  Pesticide
          Document Management System.

     (2)  Administrative Number.  The next element,  imned lately following
          the word 'under1, is the registration number,  experimental permit
          number, petition number, or other  administrative number
          associated with the earliest known submission, at the time that
          particular document was processed  into the Pesticide Document
          Management System.

     (3)  Submitter.  The third element  is the submitter,  following the
          phrase  ' submitted by1 .  When authorship  is defaulted to the
          submitter, this element is emitted.

     (4)  Volume  Identification.  The final  element  in the trailing
          parenthesis identifies the EPA accession number  of the volume in
          which the original submission  of the- study appears.  The six-
          digit accession number follows the symbol  'CDL', standing for
          "Germany Data Library" .  This  accession  nurJber is in turn
          followed by an alphabetic suffix which shows the relative
          position of the study within the volume.   For example, within
          accession number 123456, the first study vould be 123456-A; the
          second, 123456-3; the 26th, 123456-2; and  the 27th,123456-AA.

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                       Office of Pesticides Rrccra-ns
                    Registration Standard Bibliography
                   litaticns to be Considered to be Part
                        of the Data Base Supporting
                     Registrations Under the Standard
MRID           Citation

GS0077003      Eraunling, H. (1973), Migration and degradation of
               butoxycarboxime when used in insecticide strips.
               (Unpublished study received Jan. 27, 1975, submittec by
               Wacker-Chemie GmbH, Munich, W.  Germany; CDL: 227599-M.')

GS0077002      Braunling, H. (1973), Determination of Co 859 in insecticide
               strips.  (Unpublished study received Jan. 27, 1975;
               submitted bv Wacker-Chemie GmbH, Munich, W. Garmanv; CDL:
               227599-L.)

G30077005      Eraunling, H. (1974), Storage stability of insecticide
               strips.  (Unpublished study received Dec. 1, 1976; submitted
               by Wacker-Chemie GmbH, Munich,  W. Germany; CDL: 227605-A.)

GS0077006      Etaunling, H. (1976), Stability and decomposition products
               of butoxicarboxime Go 859. (Unpublished study received Dec.
               1, 1976; submitted by Wacker-Chemie GmbH, Munich, W.
               Germany; CDL: 227601-A.)

GS0077010      Huismans, J.W., and Williams, M.I. (1972), Report No.
               R3713:, Eye irritation and acute dermal toxicity studies
               with Co 755 in albino rabbits,   (Unpublished study received
               Dec. 1, 1976; prepared by Central Institute for Nutrition
               and Food Research, submitted by Wacker-Chemie GmbH, Munich,
               W. Germany; CDL; 227602-B.)

GS0077011      Koeter, H.B.W.M. (1975),  Report No. 4784, Embryotoxicity
               study in rats with Co 755. (Unpublished study received Dec.
               23, 1976; prepared by Central Institute for Nutrition and
               Food Research, submitted by Wacker-Chemie GmbH, Munich, W.
               Germany; CDL: 227373-A. )

GS0077012      Kruysse, A. (1973), Report No.  4138., Acute inhalation
               toxicity study with Co 755, 50% EC in rats.  (Unpublished
               study received Dec. 1, 1976; prepared by Central Institute
               for Nutrition and Food Research, submitted by Wacker-Chemie
               GmbH, Munich, W. Germany; CDL:  227602-A.)

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GS0077013      Mann (1974), Report No. R4384, Cn investigation into the
               toxicity of Co 755 to rainbow trout and idus idus
               melanotus.  (Unpublished study received Dec. 1, 1976;
               submitted by Wacker-Chemie GmbH, Munich, W. Germany;
               CDL: 227603-B.)

GS0077015      Mueller, F., Braunling, H., Lohringer, W., Prigge, H. and
               Mines, K. (1970), Pesticidal alpha-alkyi (or aryl)
               thioketcne 0-carbamoyloximes and their S-oxides.  Ger.
               Offen.  Patent No. 2036491.

GS0077018      Ross, D.B., Prentice, D.E., Cooke, L., Cameron, M.M. and
               N.L. Roberts (1977), Examination of butoxicarboxime for
               neurotoxicity in the domestic hen.  (Unpublished study
               received July 27, 1977; prepared by Huntingdon Research
               Centre, Huntingdon, England, submitted by Wacker-Chemie
               GmbH, Munich, W. Germany; CDL: 230903.)

GS0077019      Sinkeldam, E.J., Immel, H.R., and Leegwater, D.C.
               (1974),Report No. R4457, Sub-chronic (90-day) toxicity study
               with Co 859 in albino rats.  (Unpublished study received
               Jan. 27, 1975; prepared by Central Institute for Nutrition
               and Food Research, submitted by Wacker-Chemie GmbH, Munich,
               W. Germany; CDL: 227599-1.)

GS0077024      Til, H.P., Leegwater, D.C., Dreef-van-der Meulen, and M.
               Th. Spenjars (1973), Range finding (28-day) study with
               Co 359 in albino rats.  (Unpublished study received Jan. 27,
               1975; prepared by Central Research for Nutrition and Feed
               Research, submitted by V7acker-Chemie GmbH, Munich, W.
               Germany; CDL: 227599-H.)

GS0077026      Til, H.P. and van Benmel (1974), Report No. R4384, Sub-acute
               oral toxicity study (LC5Q-8 days) with Co 755 in Japanese
               Quail.   (Unpublished study received Dec. 1, 1976; prepared
               by Central Institute for Nutrition and Food Research,
               submitted by Wacker-Chemie GmbH, Munich, W. Germany; CDL:
               227603-A.)

GS0077022      Til, H.P., Leegwater, D.C., and Hendriksen, C.F.M.
               (1977), Report No. R5348, Determination of the acute oral
               toxicity of Co 359 as insecticide sticks to rats.
               (Unpublished study received July 27, 1977; prepared by
               Central Institute for Nutrition and Food Research, submitted
               by Wacker-Chemie GmbH, Munich, W. Germany; CDL: 230904-A.)

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GS0077023      Til, H.?., Leegvater , D.C. and  Kendriksen,  C.F..M.
               (1977), Report No. 5348, Combined crronic  tcxicity and
               carcincgenicity study with Co 755 in rats.   (Unpublished
               study received July 27, 1977; prepared by Central  Institute
               for Nutrition and Food Research, submitted  by Wacker-Chemie
               GnbH, Munich, W. Germany; CDL:  230904-B. )

GS007702S      Til, H.P. , Leegwater , D.C., Irtmel, H.R., and van der
               Keijden, C.A. (1977), Report No. R5240,  Multigeneration
               study with Co 755 in rats.  (Unpublished study received
               April 13, 1977; prepared by Central Institute for  Nutrition
               and Food Research, submitted by Wacker-Chemie GnbH, Munich,
               W. Germany; CDL: 229767-B.)

GS0077027      Van Beek, L. (1977), Eye irritation test with an extract
               from insecticide sticks in albino rabbits.   (Unpublished
               study received April 13, 1977; prepared  by  Central  Institute
               for Nutrition and Food Research, submitted  by Wacker-Chemie
               GmbH, Munich, W. Germany; CDL:  229767-A.)

GS0077029      Wacker-Chemie GmbH (1972), Determination of toxicity of
               insecticide Co 359 to fish.  (Unpublished study received
               Jan. 27, 1975; submitted by Wacker-Chemie GmbH, Munich, W.
               Germany; CDL: 227599-J.)

GS0077031      Wacker-Chemie GmbH (1974) [Product chemistry of
               butoxicarboxime.]  (Unpublished study received Dec.  1, 1976,
               submitted by Wacker-Chemie GmbH, Munich, W. Germany;
               CDL: 227606-A.)

G50077C38      wacker-Chemie GmbH (1976) Determination of  active  substance
               in formulation with NMR. (Unpublished study received March
               31, 1976 under  CDL: 227606; submitted by Wacker-Chemie GmbH,
               Munich, W. Germany)

GS0077042      Willems, M.I. (1977), Report No. 5332, Evaluation of Co 755
               in the Salmonella/Microsome mutagenicity test.  (Unpublished
               study received April 30, 1979; prepared by  the Central
               Institute for Nutrition and Food Research,  submitted by
               Wacker-Chemie GmbH, Munich, W. Germany; CDL: 238247-A.)

GS0077043      Zipf, K. (1971), Determination of the percral toxicity of
               "Co 359 Mirks toff" in rats.   (Unpublished study received by
               the Central Institute for Nutrition and Food Research,
               submitted by Wacker-Chemie GmbH, Munich, W. Germany; CDL:
               227599-E.)

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GS07704S       Zipf, K. (1971), Report en the acute oerorai  tcxicity  [to
               rabbits] of Co 359.   (Unpublished  study received Jan.  27,
               1975; prepared by Institut fur Pharisokolcqie, Tcxicoiccie
               und Pharma2ie, LYiiversitat Munchen, submitted by V/ackcr-
               Chemie GmbH, Munich, W. Germany; CDL: 227599-G. j

GS0077044      Zipf, K. (1971), Determination of  the acute  intraperitoneal
               toxicity [to rats) of Co 859.  (Unpublished  s.udy received
               Jan. 27, 1975; prepared by Ins ti tut r-.r ?'r~T-okolcqie,
               Toxicologie und Pharmazie, Universitat M-jr.cr.en, submitted by
               Wacker-Chemie GmbH, Munich, W. Germanv; ZCL:  227599-?.)

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                       Office of Pesticides Jrograns
                    Registration Standard Bibliography
                    Citations Examined and Judged to be
                    Inappropriate for Use in Developing
                               the Standard
•MRID           Citation

GS0077004      Eraunling, H. (1973), Residue analysis of Co 359.
               (Unpublished study received Jan. 27, 1975; submitted by
               Wacker-Chemie GrrH, Munich, W. Germany; CDL: 227599-X.)

GS0077009      Hackenberg, U.  (1971)t Acute toxicity of Co 359 by dermal
               application on the rat.  (Unpublished study received Jan.
               27, 1975; prepared by 1MB IK) Institute fur Biologische
               Forshung, submitted by Wacker-Chemie GmbH, Munich, W.
               Germany; CDL: 227599-C. )

GS0077014      Mann (1974), Report No. R4384, Report on determinations of
               toxicity of CO 755.  (Unpublished study received Dec. 1,
               1976; submitted by Wacker-Chemie GmbH, Munich, W. Germany;
               CDL: 227603-C.)

GS0077030      Wacker-Chemie GmbH (1973), The metabolism of
               butoxicsrboxime.(Unpublished study received Dec. 1, 1976;
               submitted bv Wecker-Chemie GmbH, Munich, W. Germany; CDL:
               227600-A.)

GS0077032      Wacker-Chemie GmbH (1974)  [Efficacy of butoxicarboxime as ,=n
               insecticide.)  (Unpublished study received Dec. 1, 1976;
               submitted by Wackar-Chemie GmbH, Munich, W. Germany;
               CDL: 227606-B.)

GS0077033      Wacker-Chemie GmbH (1974)  [Phytotoxicity of
               butoxicarboxime.)   (Unpublished study received Dec. 1, 1976;
               submitted by Wacker-Chemie GmbH, Munich, W. Germany; CEL:
               227606-C.)

GS0077034      Wacker-Chemie GmbH (1975), Conpatability of plant pin to
               plants.  (Unpublished study received Dec. 1, 1976;submitted
               by Wacker-Chemie GmbH, Munich, W. Germany; CDL: 227604-A.)

GS0077035      Wacker-Chemie GmbH (1975)  (Efficacy of butoxicarboxime as an
               insecticide.]  (Unpublished study received Dec. 1, 1976;
               submitted by Wacker-Chemie GmbH, Munich, W. Germany;
               CDL: 227604-B.)

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GS0077036      Wackar-Chemie GnbH (1976) (Efficacy of butoxicarboxime as an
               insecticide.)  (Unpublished study received Apr. 13, 1977;
               submitted bv Wacker-Chemie GmbH, Munich, W. Germany;
               CDL: 229768-A.)

GS0077038      Wacker-Chemie GmbH (19??) [Efficacy of butoxicarboxire as an
               insecticide.]  (Unpublished study received Jan. 27, 1975;
               submitted by Wacker-Chemie GmbH, Munich, W. Germany;
               CDL: 227599-C.)

GS0077037      Wacker-Chemie GmbH (19??), Conpatability of plant pin to
               plants.  (Unpublished study received Jan. 27, 1975;
               submitted by Wacker-Chemie GmbH, Munich, W. Germany;
               CDL: 227599-B.)

GS0077039      Wacker-Chemie GmbH (19??), Final report en tests to
               establish the effect of Wacko: insecticide sticks on
               plants.  (Unpublished study received Dec. 1, 1976; submitted
               by Wacker-Chemie GmbH, Munich, W. Germany; CDL: 227604-C.)

GS007040       Webb, R.E.  (1976) (Efficacy of butoxicarboxime as an
               insecticide.)  (Unpublished study received Jan. 27,
               1976;prepared by U.S. Cept.  of Agriculture, submitted by
               Wacker-Chemie GmbH, Munich,  W. Germany; CDL: 227373-D.)

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                        S tandar d Re f er er.ce --fe tor ia 1
MRID           Citation

GS0077001      Anonymous (1974), Supplement No.  3 to British Standard
               183:  1969 Recaimended Cannon Names  for Pesticides,  London,
               UK, British Standards Institution, 41 pp.

GS0077007      Chin, W.T., EXiane, W.C., Bailee,  D.L., and Stallard, D.E.
               (1976), Mechanism of degradation  of  thiofanox in aqueous
               solutions.  J. Agric. Food Chen.  24(5):107L-1073.

GS0077008      Chin, W.T., Cuane, W.C., Szalkcwski, M.S., and Stallard,
               D.E. (1975), Gas chrcmatcgraphic  determination of  thiofanox
               residues  in soil, plants and water.  J. Agric. Food  Chem.
               25(5):963-966.

GS0077016      Nishinchi, Y.  (1980), Effect of pH on the  toxicity of
               pesticides to aquatic animals.  Seitai Kagaku 28(2):73-9.

GSC077017      Nishiuchi, Y.  (1979), Tbxicity of pesticides to some
               freshwater organisms.  Suiscn Zoshoku 27(1):56-60.

GS0077020      Stenmark, A. (1977), (Butoxicarboxijn - ett bekampningsmendel
               med interressant raetod for spridning. ] Butcxicar box line, a
               pesticide with an interesting method of application.
               Vaxskyddsnotiser 41(4):104-110.

GS0077021      Szalkowski, M.B., Duane, W.C., and Chin, W.T. (1976),
               Separation and detection of thiofanox and  its metabolites by
               thin-layer chrcmatography.  J. Chrcmatography 129:426-430.

GS0077028      Vulic, M., and Braunling, H.  [Uber ein neues Be kamp
               funsver fahr en von Blattlausen und Spinnmilben
               Zierpflanzenbau mit Insektizid-Stabchen.1 New method of
               controlling leaf lice and spider  mites in ornamental plants
               with insecticide sticks (1974), Meded. Fac. Land bouwwet.
               Rijksuniv. Gent; 39(2):847-856.

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