United States
Environmental Protection
Agency
Office of
Pesticides and Toxic Substances
Washington DC 20460
August 1981
Pesticides
O-Ethyl O-(4-(methylthio)
phenyl) S-propyl
phosphorodithioate

       Sulprofos

Pesticide Registration
Standard

-------
                  Sulprofos
       Pesticide Registration Standard
Ralph Wright           Project Manager (SPRD)

Beverly Comfort        Assistant Product Manager (RD)
Jay Ellenberger        Product Manager (RD)
Linda Garczynski       Writer/Editor (SPRD)
Bruce Kapner           Project Manager (SPRD)
Ingrid Sunzenauer      Project Manager (SPRD)
               August 7, 1981

  Office of Pesticides and Toxic Substances

       Environmental Protection Agency

              401 M Street, SW

           Washington, D.C.  20460

-------
                        - TABLE OF CONTENTS -

                                                                 page
Chapter I     How to Register under a Registration Standard	  1
Chapter II    Regulatory Position and Rationale	 10



Chapter III   Summary of Data Requirements and Data Gaps	 19



Chapter IV    Product Chemistry	 36



Chapter V     Environmental Fate	 40



Chapter VI    Toxicology	 50



Chapter VII   Residue Chemistry.	 58



Chapter VIII  Ecological Effects	 62



Bibliography	 65

-------
          CHAPTER I:  HGW TO REGISTER UNDER A REGISTRATION STANDARD

    A. Organization of the Standard
    B. Purpose of the Standard
    C. Requirement to Reregister Under the Standard
    D. "Product Specific" Data and "Generic" Data
    E. Data Compensation Requirements under FIFRA 3(c)(l)(D)
    F. Obtaining Data to Fill "Data Gaps"; FIFRA 3(c)(2)(B)
    G. Amendments to the Standard

A. Organization of the Standard

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

B. Purpose of the Standard

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

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

    (B)  its labeling and other material required to be submitted comply
         with the requirements of this Act;

    (C)  it will perform its intended function without unreasonable  adverse
         effects on the environment; and

    (D)  when used in accordance with widespread and commonly  recognized
         practice it will not generally cause unreasonable adverse effects
         on the environment."

In making these findings, the Agency reviews a wide range of data which
registrants are required to submit, and assesses the risks and benefits
associated with the use of the proposed pesticide.  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  (USDA), routinely reviewed registration applications on a  "product
by product" basis, evaluating each product-specific application somewhat
independently.   In the review of products containing  similar  components,  there
was little opportunity for a retrospective review of  the full range of
pertinent data available  in Agency files and  in  the public  literature.  Thus
the "product by product"  approach was often inefficient and sometimes  resulted
in inconsistent or incomplete regulatory judgments.

Second, over the years, as a result of inevitable and continuing advances in
scientific knowledge, methodology, and policy, the data base  for many
pesticides came  to be considered inadequate by current scientific  and
regulatory standards.  Given the long history of pesticide  regulation  in
several agencies, it is even likely that materials may have been lost  from
the data files.  When EPA issued new requirements for registration in  1975 (40
CFR 162) and proposed new guidelines for hazard  testing in  1978  (43 FR 29686,
July 10, 1978 and 43 FR 37336, August 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)].

Facing the enormous job of re-reviewing and calling-in new  data for the
approximately 35,000 current registrations, and  realizing the inefficiencies of
the "product by product"  approach, the Agency decided that  a  new,  more
effective method of review was needed.

A new review procedure has been developed.  Under it, EPA publishes documents
called Registration Standards, each of which  discusses a particular pesticide
active ingredient.  Each  Registration Standard summarizes all the  data
available to the Agency on a particular active ingredient and its  current uses,
and sets forth the Agency's comprehensive position on the conditions and
requirements for registration of all existing and future products  which contain
that active ingredient.   Ihese conditions and requirements, all of which  must
be met to obtain or retain full registration  or  reregistration under Section
3(c)(5) of FIFRA, include the submission of needed scientific data which  the
Agency does not now have, compliance with standards of toxicity, composition,
labeling, and packaging,  and satisfaction of  the data compensation provisions
of FIFRA Section 3(c)(l)(D).

The Standard will also serve as a tool for product classification.  As  part  of
the registration of a pesticide product, EPA  may classify each product  for
"general use" or "restricted use"  [FIFRA Section 3(d)].  A  pesticide is
classified for "restricted use" when some special regulatory  restriction  is
needed to ensure against  unreasonable adverse effects to man  or the
environment.  Many such risks of unreasonable adverse effects can  be lessened

-------
if expressly-designed label precautions are strictly followed. Thus the  special
regulatory restriction for a "restricted use" pesticide is usually a
requirement that it be applied only by, or under the supervision of, an
applicator who has been certified by the State or Federal government 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
is stated in the second chapter.

C. Requirement to Reregister Under the Standard

FIFRA Section 3(g), as amended in 1978, directs EPA to reregister all currently
registered products as expeditiously as possible.  Congress also agreed  that
reregistration should be accomplished by the use of Registration Standards.

Each registrant of a currently registered product to which this Standard
applies, and who wishes to continue to sell or distribute his product in
commerce, must apply for reregistration.  His application must contain proposed
labeling that complies with this Standard.

EPA will issue a notice of intent to cancel the registration of any currently
registered product to which this Standard applies if the registrant fails to
comply with the procedures for reregistration set forth in the Guidance  Package
which accompanies this Standard.

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

In the course of developing this Standard, EPA has determined the types  of data
needed for evaluation of the properties and effects of products to which the
Standard applies, in the disciplinary areas of Product Chemistry, Environmental
Fate, Toxicology, Residue Chemistry, and Ecological Effects.  These
determinations are based primarily on the data Guidelines proposed in 43 FR
29696, July 10, 1978; 43 FR 37336, August 22, 1978; and 45 FR 72948,
November 3, 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 been waived.  On  the other  hand,  in
some cases studies not required by the Guidelines may be needed because  of  the

-------
particular composition or use pattern of products the Standard covers; if so,
the Standard explains the Agency's reasoning.  Data guidelines have not yet
been proposed for the Residue Chemistry discipline, but the requirements for
such data have been in effect for some time and are, the Agency believes,
relatively familiar to registrants.  Data 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. Data 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 relevant to an evaluation of
     the risks and benefits of all products containing that ingredient
     (or all such products having a certain use pattern),  regardless
     of any such product's unique composition.

The Agency requires certain "product specific" data for each  product to
characterize the product's particular composition and physical/chemical
properties (Product Chemistry), and to characterize the product's acute
toxicity (which is a function of its total composition).   The applicant for
registration or reregistration 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 EPA to evaluate the
product.  For such purposes, "product specific" data on any product other than
the applicant's is irrelevant, unless the other product is closely similar in
composition to the applicant's.  (Where it has been found  practicable to group
similar products for purposes of evaluating, with a single set of tests, all
products in the group, the Standard so indicates.)  "Product  specific" data  on
the efficacy of particular end-use products 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 formulated from a registered manufacturing-use product
permitting such formulations) and to each manufacturing-use product with
labeling that allows it to be used to make end-use products with that  use
pattern.  Thus, for example, a subchronic oral dosing study is needed  to
evaluate the safety of any manufacturing-use product that legally  could be used
to make an end-use, food-crop pesticide.  But if an end-use product's  label
specified it was for use only in ways that involved no food/feed exposure  and
no repeated human exposure, the subchronic oral dosing study would not be
required to evaluate the product's safety; and if a manufacturing-use  product's
label states that the product is for use only in making end-use products not
involving food/feed use or repeated human exposure, that subchronic oral study
would not be relevant to the evaluation of the manufacturing-use product either.

If a registrant of a currently registered manufacturing-use or end-use product
wishes to avoid the costs of data compensation  [under FIFRA Section 3(c)(l)(D)]
or data generation  [under Section 3(c)(2)(B)] for "generic" data that  is
required only with respect to some use patterns, he may elect  to delete those
use patterns from his labeling at the time he 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
registered product.  (Bolstar®, with its new active ingredient sulprofos,  is
such a product.)

The statute provides that data 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 15 years after  the  initial
registration.  Mobay Chemical Corporation's registration for its Bolstar®
product was issued on February 15, 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 compensation 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 EPA (or to its predecessor
     agencies, USDA or FDA), on or after January 1, 1970;

  2. The data were submitted to EPA  (or USDA or FDA) by some other
     applicant or registrant in support of an application for an
     experimental use permit,  an amendment adding  a new use to a
     registration, or for registration, or to support or maintain
     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)  from 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 EPA in developing the Standard must be
the subject of an offer to pay compensation, and must submit with his
application the appropriate statements evidencing  his compliance with FIFRA
Section 3(c)(l)(D).

An applicant would never be required to offer to pay for "product specific"
data submitted by another firm.  In  many, if not in most cases, data which 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
determining whether the applicant's  product is registrable.  There may be

-------
cases, however, where because of close similarities between the composition of
two or more products, another firm's data may suffice to allow EPA to  evaluate
some or all of the "product specific" aspects of the applicant's product.  In
such a case, the applicant may choose to cite those data instead of submitting
data from tests on his own product, and if he chooses that option,  he  would
have to comply with the offer-to-pay requirements of Section  3(C)(1)(D)  for
that data.

Each applicant for registration or reregistration of a manufacturing-use
product, and each applicant for registration or reregistration of  an end-use
product, who is not exempted by FIFRA Section 3(c)(2)(D), must comply  with the
Section 3(c)(l)(D) requirements with respect to each item of  "generic" data
that relates to his product's intended uses.

A detailed description of the procedures an applicant must follow  in applying
for reregistration (or new registration) under this Standard  is found  in the
Guidance Package for this Standard.

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

Some of the kinds of data EPA needs for its evaluation of the properties and
effects of products to which this Standard applies have never been submitted  to
the Agency  (or, if submitted, have been found to have deficiencies rendering
them  inadequate for making registrability decisions) and have not  been located
in the published literature search that EPA conducted as part of preparing this
Standard.  Such instances of missing but required data are referred to in the
Standard as "data gaps".

FIFRA Section  3(c)(2)(B), added to FIFRA by the Congress in  1978,  authorizes
EPA to require registrants to whom a data requirement applies to generate (or
otherwise produce) data to fill such  "gaps" and submit those  data  to EPA. EPA
must  allow a reasonably sufficient period for this to be accomplished.  If a
registrant fails to take appropriate and timely steps to fill the  data gaps
identified 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 Standard lists, in the third chapter, the  "generic" data gaps  and  notes  the
classes of products to which these data gaps pertain.  The Standard also points
out that to be registrable under the Standard, a product must be  supported by
certain required "product specific" data.  In some cases, the Agency may
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
issue Section 3(c)(2)(B) directives requiring the registrants to take
appropriate steps to fill all identified data gaps — whether the  data in
question are "product specific" or "generic" — in accordance with a schedule.

Persons who wish to obtain registrations for new products under this Standard
will be required to submit (or cite) sufficient "product specific" data  before
their applications are approved.  Upon registration, they will be  required
under Section 3(c)(2)(B) to take appropriate steps to submit data  needed to
fill "generic" data gaps.  (We expect they will respond to this requirement by
entering into cost-sharing agreements with other registrants who previously
have been told they must furnish the data.)  The Guidance Package  for this
Standard details the steps that must be taken by registrants to comply with
Section 3(c)(2)(B).

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 compositions,
product chemistry data, hazard data, toxicity levels, or labeling  that do not
meet the requirements of the Standard, will automatically be considered  by the
Agency to be requests for amendments to the Standard.   In response to such
applications, the Agency may request additional data to support the proposed
amendment to the Standard, or may deny the application  for registration  on the
grounds that the proposed product would cause unreasonable adverse effects to
the environment.  In the former case, when additional data have been
satisfactorily supplied, and providing that the data do not indicate the
potential for unreasonable adverse effects, the Agency will then amend the
Standard to cover the new registration.

Each Registration Standard is based upon all data and information  available to
the Agency's reviewers on a particular date prior to the publication date.
This "cut-off" date is stated at the beginning of the second chapter.  Any
subsequent data submissions and any approved amendments will be incorporated
into the Registration Standard by means of addenda,  which are available  for
inspection at EPA in Washington, 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.

-------
While the Registration Standard discusses only the uses and hazards of products
containing the designated active  ingredient(s),  the Agency  is  also concerned
with the potential hazards of some inert ingredients and  impurities.
Independent of the development of any one Standard, the Agency has initiated
the evaluation of some inert pesticide ingredients.  Where  the Agency has
identified inert ingredients of concern in a  specific product  to which the
Standard applies, these  ingredients will be pointed out in  the Guidance  Package.

-------
               Chapter II:  REGULATORY POSITION AND RATIONALE


     A.  Introduction
     B.  Description of Chemical
     C.  Regulatory Positon
     D.  Regulatory .Rationale
     E.  Criteria for Registration under the Standard
     F.  Required Labeling
     G.  Tolerance Reassessment
     H.  New or Amended Registrations


A.   Introduction

This chapter presents the Agency's regulatory position and rationale  based
upon an evaluation of all available data related to pesticidal
products containing sulprofos  (0-ethyl O-[4-(methylthio)phenyl] S-propyl
phosphorodithioate) as their sole active ingredient.  Following an  abbreviated
chemical description, this chapter presents the regulatory position and
rationale, the criteria for registration/reregistration of sulprofos  containing
products, labeling considerations, and tolerance reassessment.  A summary of
all data requirements is contained within Chapter III.  A discussion  of the
data upon which the Agency's regulatory postion is based is presented within
disciplinary chapters IV through VIII.

B.   Description of Chemical

Sulprofos (O-ethyl O-[4-(methylthio)phenyl] S-propyl phosphorodithioate)  is
currently conditionally registered with the U.S. Environmental Protection
Agency as an insecticide/acaracide.  At the time of publication of  this
Standard, cotton is the sole site of application.  Sulprofos, in  the
literature, may be alternately identified as BAY NTN 9306, Helothion® and
Bolstar®, the registered trade name under which sulprofos is currently
marketed.  The OPP Internal Control Number  (EPA Shaughnessy Number) is 111501.

C.  Regulatory Position

Sulprofos, as described within this Standard, may be registered  for sale,
distribution, reformulation and use within the United States and  its
territories.  The Agency in preparing this Standard, has considered the
scientific data obtained from  the open literature through February  12, 1981,
and those data submitted by the registrant up through the date of publication
of this Standard.  Based upon  a review of these data, the Agency  finds that
sulprofos has neither met nor  exceeded any of the risk criteria  found within
section 162.11(a) of Title 40  of the U.S. Code of Federal Regulations. The
Agency has thus determined that sulprofos does not appear to cause
                                      10

-------
unreasonable adverse effects to either man or the environment when used  in
accordance with prescribed label directions and precautions.  Currently
registered sulprofos products may be reregistered subject to the conditions
imposed under this chapter, and to the data requirements identified
within Chapter III.  New products, complying with the terms and conditions
established for reregistration, may be registered under this standard.

D.  Regulatory Rationale

A reasonably complete data base is available for registration support  in
relation to sulprofos.  Those data which have yet to be developed, are
princinpally confirmatory in nature.  Sulprofos, as defined by available
chronic test data, does not appear to induce oncogenicity, teratogenicity,
mutagenicity or reproductive inhibition.  Sufficient acute toxicity  data are
available to permit consideration for registration under those parameters
provided within paragraphs E.l.b. and E.2.b. of this chapter.

Although certain  items of data remian outstanding, the Agency has concluded
to register or reregister sulprofos containing products.  The Agency provides
as a basis for this decision the following:

1.  No adverse effects data of regulatory concern have been revealed in  the
    review of those studies made available to the Agency.  The Agency,
    therefore, has concluded that the known risks, as mitigated by product
    labeling, are of such a nature as to warrant no immediate adverse
    regulatory action.

2.  No confirmed  pesticide poisioning or environmental effect  incidents  have
    been reported to the Agency.

3.  The Agency's  policy, in keeping with the  intent of the Federal  Insecticide,
    Fungicide, and Rcdenticide Act  (FIFRA), is to neither routinely  cancel
    existing product registrations nor deny new registrations  for products for
    which incomplete data bases may exist.   (See sections 3(c)(2)(B) and
    3(c)(7) of the FIFRA.) The Agency believes that publication of  this
    Standard permits not only the identification of data needs, but  also
    allows for the upgrading of labels during the period  in which the  required
    data are being generated.  Upon receipt and review of outstanding  data, the
    Agency will reassess the registrability of each given chemical.

E.  Criteria for  Registration Under The Standard

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

  - Contain 0-Ethyl 0-[4-(methylthio)phenyl] S-propyl phosphorodithioate as the
    sole active ingredient  (herein defined as including products containing up
    to and including 15% petroleum distillate),
                                       11

-------
  - bear required labeling,

  - conform to the product composition standard, acute toxicity limits,  and  use
    pattern requirements as specified in part l.a., b., and c., and  2.a.,  b.,
    and c., respectively.

The applicant for registration or reregistration of products subject to  this
Standard must comply with all terms and conditions described within  this
Standard, including a commitment to fill data gaps in accord 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 the  FIFRA, as
amended, 7 U.S.C. 136(c)(1)(D).  As discussed within Chapter I, applicants for
registration under this Standard should contact the Agency for specific
instructions, including updated information on data requirements and companies
whose data must be cited and to whom compensation must be offered.

     1.  Manufacturing-Use Products

         a.  Product Composition Standard

To be elegible for registration/reregistration under this standard,
manufacturing-use products must contain sulprofos as their sole active
ingredient.  Such formulations may contain percentages of active ingredient  up
to and  including 87.0%.  Each formulation proposed for registration  must be
fully described within an appropriate certification of limits.

         b.  Acute Toxicity Limits

Due to  the intended use of manufacturing-use sulprofos products, there are no
acute toxicity limits.

         c.  Use Patterns

To be eligible for registration/reregistration under this standard,
manufacturing-use products must bear labeling limiting use to the  formulation
of insecticide/acaracide end-use products intended for application to cotton.

     2. End-use Products

         a.  Product Composition Standard

Any end-use product containing 64% sulprofos in combination with 0 to 15%
petroleum distillate will be considered under this Standard.  Each proposed
formulation must be fully described within an appropriate certification  of
limits.
                                       12

-------
        b.  Acute Toxicity Limit

The Agency, given the single agricultural site of application, will  consider
for registration end-use products of any toxicity category.  This acceptance,
however, is predicated upon label incorporation of appropriate hazard warnings,
precautionary, and use restriction statements as may be required.  The Agency
will, therefore, consider the registration of any emulsifiable concentrate
formulation in the following categories:

                                      Toxicity Category
                                   I      II    III     IV

     Acute oral Toxicity          Yes    Yes    Yes    Yes

     Acute Dermal Toxicity        Yes    Yes    Yes    Yes

     Acute Inhalation Toxicity    Yes    Yes    Yes    Yes

     Primary Dermal  Irritation    Yes    Yes    Yes    Yes

        c. Use Pattern

To be considered under this Standard, end-use products must  bear directions for
use as an insecticide/acaricide intended for either ground or aerial
application to cotton.

F.  Required Labeling

All manufacturing-use and end-use sulprofos products must bear appropriate
labeling as specified in 40 CFR 162.10.  The guidance package which  accompanies
this Standard contains specific information regarding label  requirements.

     1.  Manufacturing-Use Products

All manufacturing-use sulprofos products must bear a label statement which
provides that the product may be used only in the formulation of
insecticide/acaracide products approved by the United States Envionmental
Protection Agency.

     2.  End-use Products

         a. Human hazard precautionary statements

The human hazard precautionary statements are to be segregated according to the
various routes of exposure, with the routes of greatest hazard being listed
first.  The statements will be consistent with those provided by the Guidance
Package.
                                       13

-------
         b.  Environmental hazard statements

The Agency believes that end use product application must be restricted  to
trained applicators because of the apparent high toxicity of sulprofos to fish
and wildlife. It is the Agency's belief that such a restriction will minimize
the potential for over-application, and application to nontarget  sites.   End
use sulprofos labeling, therefore, must bear the following  statement:

                          "RESTRICTED USE PESTICIDE"
             "For retail sale and use only by Certified Applicators
             or persons under their direct supervision and only for
           those uses covered by the Certified Applicator's certification"

The "Restricted Use" classification of sulprofos will be reevaluated upon
submission and review of those pertinent studies identified as data gaps within
Chapter III  of this Standard.

In conjunction with the "Restricted Use" classification, the following
environmental hazard statements pertinent to the potential  effect of sulprofos
application  on fish and wildlife must appear on end-use product labeling.

"This pesticide is toxic to fish and wildlife.  Use with care when  applying  in
areas frequented by wildlife or adjacent to any body of water.  Do  not apply
directly to  water.  Do not apply when weather conditions favor run-off or drift
from target  areas.  Do not contaminate water by cleaning of equipment or
disposal of  wastes."

The Agency has additionally noted that sulprofos can pose a threat  to honey
bees.  In this regard, end-use sulprofos labeling must bear the following
environmental hazard statement:

"This product is toxic to bees exposed to direct treatment  or residues on crops
or weeds.  Do not apply this product or allow it to drift to crops  or weeds  on
which bees are actively foraging."

G.  Tolerance Reassessment

Sulprofos has been granted those tolerances requisite for application  to
cotton. (See 43 FR 32132 of July 25, 1978).  Tolerances of  0.01 ppm have been
established  for the fat, meat and meat by-products of cattle, goats, hogs,
horses poultry and sheep.  A 0.001 ppm tolerance level has  been established  for
milk and eggs, and a 0.5 ppm level for cottonseed.  Since toxicological  data
considered in support of those tolerances established as of July  25, 1978, are
                                      14

-------
identical to those data reviewed under this Standard, the Agency does not
believe that there exists any reasonable cause to reassess current sulprofos
tolerances.  In similar fashion, the Agency has noted no additional residue
chemistry, international tolerance, or similar considerations which might give
cause for a reassessemt of existing tolerances.
 Based upon the the 10 ppm no observed effect level  (NOEL) derived from the two-
year dog-feeding study discussed within Chapter VI of this Standard, the
acceptable daily intake (ADI) for man has been calculated to be 0.025 mgAg
body weight per day.  The established tolerances theoretically represent 0.32
percent of the acceptable daily intake (ADI).  The theoretical maximal  residue
contribution (TMRC) in the human diet from these tolerances is 0.0048 mg/day.
The Agency, upon consideration of all available toxicity data, has concluded
that a sulprofos TMRC of 0.0048 mg/day would pose no risk to human health.

The Agency has, however, noted in its review of rotational crop residue data
that sulprofos residues can occur in crops planted in excess of one year
following the last application (see Chapter V).  In light of the proven
potential for rotational residues, the Agency has determined that sufficient
cause exists to impose, in the absence of petitions for rotational crop
tolerances, a rotational crop restriction.  The following statement must appear
upon all end-use sulprofos labeling:

                 "Rotational crops may not be grown  in fields
                          treated with this product."

The registrant(s) may, at their discretion, amend the above rotational  crop
restriction by providing a six month rotational restriction specific to
potatoes and cucumbers and a 60 day rotational restriction specific to  turnips
and peas.  A complete restriction for all other crops must, however, accompany
any statement pertaining to potatoes, cucumbers, turnips and/or peas.   The
registrant(s), further, retain options for the amendmending or removal  of the
rotational crop restriction.  The registrant(s) may submit environmental fate
data to support a rotation interval which does not result in a pesticide
residue in the rotated crop.  Alternatively, the registrant(s) may submit a
petition for tolerance for the nontarget crop or request an exemption from a
tolerance.

An additional Agency concern regarding tolerances involves current labeling
permitting the application of tank mixes of sulprofos and Guthion to cotton up
to 21 or 14 days before harvest.  Although it is not Agency policy to
customarily address tank mixes within single active Standards, the appearance
of the tank mix instructions only upon Bolstar® 6 labeling necessitates the
current incorporation of a label restriction.  As both compounds are
cholinesterase inhibitors, samples bearing residues of both compounds at their
respective tolerance levels  (0.5 ppm) would be in violation of 40 CFR
180.3(e)(l).  The Agency believes, in view of data indicating  that Guthion
                                       15

-------
residues applied 14 days before harvest would not be significant  «0.05 ppm),
has concluded that the tank mix, if not followed by subsequent applications  of
Guthion, would not be in violation of 180.3(e)(l).  Since current Guthion
labeling, however, would permit additional applications  (up to one day before
harvest), it is the Agency's judgment that the tank mix recommendation must
bear a restriction prohibiting any additional application of Guthion within  14
days of harvest.

H.  New and Amended Registrations Under This Standard

Principal among the goals of the Registration Standards process is not only  the
reregistration of currently registered pesticide chemicals, but also the
creation of a mechanism for the registration of new and added uses of  a
chemical.  Although sulprofos bears current registration only for use  on
cotton, it may be anticipated that new sites of application will  be sought.
Being a broad spectrum organophosphate insecticide/acaracide, it  would be
virtually impossible to anticipate future registration actions with any degree
of certainty.   It is, however, possible to define the general applicability  of
this Standard.

The Agency in its review of the current data base has determined  that  sulprofos
does not appear to present any human chronic toxicity hazard.  The Agency  can
not make a categorical statement with respect to chronic hazard until  such time
as certain mutagenicity and teratogenicity studies, identified in Chapter  III,
are submitted and reviewed.  Assuming these studies produce negative findings,
the Agency will adopt the results and conclusions of this Standard for all
future registration actions. Additional chronic data will not be  required
except under those circumstances in which major alterations in use pattern and
formulation might be sought.  An example of such an alteration would be the  use
of sulprofos in an aerosol or pressurized spray formulation intended for  indoor
use.  Should such a registration be sought, the Agency would require the
submission of an acceptable subchronic inhalation toxicity study  as described
under Guideline section 163.82-4.  The Agency might also seek chronic  toxicity
data should the technical synthesis process be altered to permit  the
introduction of additional unintentional ingredients or  should the ratio  of
those unintentional ingredients currently known to the Agency be  radically
altered.  Similarly, the addition of inert ingredients into  the manufacturing-
use product(s) might necessitate the submission of additional data.

In similar fashion, the Agency will seek to apply the acute  toxicity data
presented within this Standard in as broad a fashion as  may be deemed
scientifically justifiable.  With regard to manufacturing-use sulprofos,  the
potential range of formulations is limited.  The Agency  is not in a position to
ascertain whether or not increasing the percentage of parent sulprofos,
currently 87.0 percent, would alter a given toxicity category.  Similarly, any
reduction from the current 87.0 percent level may or may not entail  the
addition of unintentional ingredients.  As a consequence, no specific  range  may
                                       16

-------
be established under this standard.  This does not, however, preclude Agency
use of the current acute toxicity data base.  The Agency will  review the
discussion on formation of unintentional ingredients as well as  the  delaration
and certification of ingredient limits for any new manufacturing-use
product(s) and, from these data, make a determination as to the  necessity  for
additional acute studies.

In relation to end use sulprofos products, the current data base was
established as a result of tests conducted upon a 64 percent sulprofos
formulation containing 15 percent petroleum distillates.   As discussed  within
Chater VI of this Standard, the acute toxicity of the end-use  product is equal
to or less than that of the manufacturing-use product for  each criteria except
eye irritation.  The Agency will, therefore, accept, without the submission  of
additional acute toxicity data, the  registration of any emulsifiable
concentrate end use product having 64 percent or less sulprofos  as its  sole
active ingredient.  This acceptance  is based on Agency review  of the product
identity and disclosure of ingredients statement accompanying  each application
for registration.  In only those cases where Agency review reveals the  presence
of an inert ingredient of known or suspected acute toxicological significance
will additional acute toxicity data  be requested.  The eye irritancy is thought
to be related to the petroleum distillate.  Petroleum distillates are
additionally known to manifest other acute toxicity symptoms.  The Agency  has,
therefore, established a current data applicability limit  to products
containing 15 percent or less  petroleum distillates.  Registrants wishing  to
register an end-use formulation containing a significantly lessened  percentage
of active ingredient may rely  upon the current data base.  It  must be noted,
however, that in the absence of additional acute toxicity  data,  product
labeling must bear those precautionary statements indicated by the current data
base.

The current Environmental Fate data  base, like that for toxicology,  is
reasonably complete.  There remains  some question with regard  to the fate  of
sulprofos when applied to muck soil, and in relation to the movement of
sulprofos and certain of its degradation products in the environment.   A
sufficient data base is, however, available to support certain additonal
patterns of use.  The Agency will consider, upon submission of acceptable
adsorption/desorption data and applicable crop specific residue  chemistry  data
(see Chapters V and VII), the  registration of emulsifiable concentrate
formulations falling within the concentration range described  above  for all
field and vegetable crops.  The general applicability of the data base  is
limited, in part, as follows:   (1)   crops grown  in muck soils  will not  be
registrable until such time as the existing muck soil dissipation data  may be
clarified or new data submitted,  (2) as some question remains as  to the
movement of sulprofos and certain of its degradation products, the Agency  will
require a sandy soil use restriction, and  (3)  the addition of leguminous  crops
will require a reinvestigation of potential breaks in the  nitrogen fixation
cycle.
                                       17

-------
In addition to field and vegetable crops, the existing data  base  is broadly
applicable to other potential sites of application.  Only those studies unique
to the newly proposed site need be pursued.  Forest use,  as  an example, would
require those additional items of data identified under  section 163.62-10(d).
Greenhouse use, as another example, would require the generation  of both
volatility and adsorption data.  In all cases, the Agency will strive to apply
the existing data base, requiring only those studies which are unique to a
given use pattern.  To ascertain the need for additonal  data,  the data base
presented by this standard may be compared to the site specific requirements
outlined under Guideline section 163.62-6.

Unlike the data bases for either toxicology or environmental fate, the
ecological effects data base remains somewhat incomplete.  The available data
strongly suggests that sulprofos and/or its degradation  products  is acutely
toxic to avian and aquatic species.  The Agency must, therefore,  exercise
caution in extending the current data base in support of additonal sites of
application,  tfritil such time as the Agency may receive  and  evaluate the
adsorption/desorption and avian field studies identified as  data  gaps in
Chapter III of this Standard, the Agency must not attempt to identify
additional registerable sites.  The Agency will, however,  entertain
applications for new or amended registration and on a case-by-case basis apply
the existing data base for added field and vegetable crops.  The  Agency does
not believe that the current data base would permit the  extension of
registration beyond certain, field and vegetable crop sites  of application.
Aquatic, forest, and similar sites of fish and wildlife  concern are not
supportable under the current data base.
                                      18

-------
           CHAPTER III:  SUMMARY OF DATA REQUIREMENTS AND DATA GAPS
     A.  Introduction
     B.  Table A - Generic Data Requirements
     C.  Table B - Product Specific Manufacturing Use  Products  Data Requirements
     D.  Table C - Product Specific End-Use Product  Data  Requirements

A. Introduction

Applicants for registration of manufacturing-use and end-use  sulprofos
products must cite or submit the  information  identified as  required in the
tables in this chapter.  The tables applicable  to end-use products indicate
whether the product to be tested  is the  technical grade or  formulation.   Data
generated on one formulation may  be used to satisfy  the data  requirement for a
substantially similar formulation.  Information on which  product specific data
requirements are already met is available in  the guidance package.

Listed before each requirement is the  Proposed  Guidelines section which
describes the type of data and when the  data  are required to  be submitted [43
FR, 29696 of July 10, 1978; and 43 FR,   37336 of August 22, 1978].
Justification for requiring the test is  provided in  the Guidelines.  A
discussion of why data additional to that already submitted are necessary, or
why data normally required are not necessary  for this  chemical, is explained
in footnotes to the tables.  The  data  requirements specified  are the minimum
that will be required.  Areas where additional  data  may be  required as the
result of tiered testing are indicated.
                                       19

-------
 Guidelines
 Citation
 163.62-7(b)
                                                     Table A:  Sulprofos
                                  Generic Data Requirements:  Environmental Fate (Chapter V)
Name of Test
                        Are Data
                        Required?
  Composition
Hydrolysis
 163.62-7(c)     Photodegradation
                                         yes
                         yes
 163.62-8(b)     Aerobic Soil Metabolism  yes
 163.62-8(c)     Anaerobic Soil
                metabolism
                Microbial Metabolism:

                (2)  Effects of Microbes
                    on Pesticides
                (3)  Effects of
                    Pesticides on
                    Microbes

                Activated sludge
                metabolism
                         yes
                         reserved—
                                 2/
                         reserved-
                         reserved—
  Tech. or
  Radiolabeled
  Analytical Gr.

  Tech. or
  Radiolabeled
  Analytical Gr.

  Tech. or
  Radiolabeled
  Analytical Gr.

  Tech. or
  Radiolabeled
  Analytical Gr.
Tech. or
  Radiolabeled
  Analytical Gr.

Tech. or
  Radiolabeled
  Analytical Gr.

  Tech. or
  Radiolabeled
  Analytical Gr.
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
Bibliographic
Citation
Must Additional Data
be Submitted Under
FIFRA 3(C)(2)(B)?
If so, due when?	
                                                                yes
                                                                                yes
                                                                yes
      yes
                      GS0076-034
                      GS0076-025,-026,
                      -098
                                                                                GS0076-167
                                                                                GS0076-034
                                                                                                                         no
                                                                                                         no
                                               no
                                                                                                         no
                    GS0076-143
                    GS0076-108,-144,
                      -145,-177
All data  requirements  are current as of August,  1981.  Refer to the guidance package for updated requirements.  f>
numerical bibliography (MRID)  is provided at the end of this Standard.

I/ As discussed within Chapter V, the available data indicate that sulprofos and/or its degradation products may
~  cause  a break  in  the nitrogen cycle.  Although the Agency does not believe it necessary to identify a data
   gap  for cotton use,  the Agency may require additional data should registration be sought for sulprofos use on
   crops  for which nitrogen fixation is agriculturally important.
2/ The  requirement for submission of these data is currently being reserved pending the review and modification
~  of the testing protocols.   Consequently, the absence of acceptable data does not constitute a data gap.
                                                                     20

-------
                                                      Table A:  Sulprofos
                                 Generic Data Requirements:  Environmental Fate  (Chapter V)
Guidelines     Name of Test
Citation
                        Are Data
                        Required?
Composition
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
Bibliographic
Citation
Must Additional Data
be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
163.62-9(b)     Leaching
                         yes
 163.62-9(d)     Adsorption/Desorption    yes
 163.62-10(b)    Terrestrial Field
                Dissipation:
                (1)  Field & Vegetable
                    Crops
                         yes
Tech. or
Radiolabeled
Analytical Gr.

Tech. or
Radiolabeled
Analytical Gr.
Emulsifiable
Concentrate
       yes
                                                                 no
GS0076-024,-025
       yes
GS-0076,016,-017,
-018,-019,-057,-058,
-059,-060,-061,-062,
-063,-064,-065,-066,
-067,-068,-075,-084,
-151,-156,-158,-167
163.62-10(f)
Combination and
tank mix field
dissipation
                                                        rese;
                                                                                                            no
                                                  yes/8 mo.—
All data requirements are current as of August,  1981.   Refer to the guidance package  for updated requirements.  A
numerical bibliography (MRID)  is provided at the end of this Standard.

I/ Adsorption/desorption coefficients must be provided  for  all  degradation products shewn to comprise 10 percent
   or more of  applied activity.

_2/ The Agency,  in reviewing available muck soil  dissipation data, has noted inconsistencies in the findings.  The Agency
   does  not, however, deem the absence  of valid  muck soil dissipation data to be critical to the cotton pattern of use for
   which sulprofos is currently  registered.  Should new uses, involving crops grown in muck soil, be pursued,
   additional dissipation data will  be  requested.

3/ Not applicable in  single active ingredient Standards.
                                                                     21

-------
                                                      Table A:  Sulprofos
                                 Generic Data Requirements:  Environmental Fate  (Chapter V)
Guidelines
Citation
Name of Test
Are Data
Required?
                                        Composition
                  Does EPA Have Data
                  to Partially or
                  Totally Satisfy
                  this Requirement?
                   Bibliographic
                   Citation
                  Must Additional Data
                  be Submitted Under
                  FIFRA 3(c)(2)(B)?
                  If so, due when?	
163.62-ll(b)
Accumulation in
Rotational Crops
163.62-11(d)   Fish Accumulation
 yes
                         yes
Radiolabeled
Analytical Gr.
Followed by
Formulation
                Tech. or
                Radiolabeled
                Analytical Gr.
partial
                        yes
GS0076-001,-002,
-003,-004,-005,-006,
-007,-008,-009,-010,
-011,-012,-013,-014,
-015,-056,-173

GS0076-139
All data requirements are current as of August, 1981.  Refer to the guidance package for updated requirements.   A
numerical bibliography  (MRID) is provided at the end of this Standard.

I/ Removal of rotation crop restriction requires one of the following:

   a) Environmental fate data to support a rotation interval which does not result  in a pesticide  residue
      in the rotated crop;

   b) A tolerance for the nontarget crop;

   c) An exemption from a tolerance.
                                                                 no
                                                                    22

-------
                                                       Table A:   Sulprofos
                                          Generic Data Requirements:   Toxicology (Chapter VI)
Guidelines
Citation
Name of Test
Are Data
Required?
Composition
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
Bibliographic
Citation
Must Additional Data
be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
163.81-1
Acute Oral Toxicity
   yes       Each Product or
             Substantially
             Similar Product
                                                                                 yes
                                        GS0027-125,-126,
                                        -130,-131,-132,-133,
                                        -134,-135,-136,-137
                                                                                                                           no
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
163.81-7
163.82-1
Acute Dermal Toxicity
Acute Inhalation Toxicity
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
Acute Delayed
Neurotoxicity
Subchronic oral
Toxicity
yes
yes
yes
yes
yes
yes
yes
Ea. Prod, or Substan.
Sim. Prod.
Ea. Prod, or Substan.
Sim. Prod.
Ea. Prod, or Substan.
Sim. Prod.
Ea. Prod, or Substan.
Sim. Prod.
Ea. Prod, or Substan.
Sim. Prod.
Ea. Prod, or Substan.
Sim. Prod.
Tech. Grade of A.I. .
yes
yes-
yes
yes
yes
yes
yes
GS0076-122
GS0076-102
GS0076-092
GS0076-092
GS0076-118
GS0076-181
GS0076-091,-109,
-110
no
no
no
no
no
no
noi/
All data  requirements are current as of August,  1981.   Refer to the guidance package for updated requirements.  A
numerical bibliography (MRID)  is provided at the end of this Standard.

I/ As noted within Chapter VI  of this Standard,  the subchronic oral toxicity data submitted for Agency review do not
~~  fully  comply with Guideline requirements.  As provided under section 163.82-1(c)(6)(ii), tests conducted with
   nonrodents must be of a six month duration.  The available subchronic dog feeding study was conducted for a period
   of only 90 days and,  hence, must be judged as supplementary data only.  The availability of negative chronic feeding
   studies obviates the  necessity for additional short-term testing.  The Agency therefore, has concluded that additional
   subchronic oral toxicity studies need not be  submitted.
                                                                     23

-------
                                                      Table A:  Sulprofos
                                         Generic Data Requirements:  Toxicology  (Chapter VI)
Guidelines Name of Test
Citation
Are Data
Required?
Composition
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
Bibliographic
Citation
Must Additional Data
be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
163.82-2       Subchronic  21-Day
               Dermal Toxicity

163.82-4       Subchronic  Inhalation
               Toxicity

163.82-5       Subchronic  Neurotoxicity
yesi/
yes
                        no
                                                                   no
Tech. Grade of A.I.     partial
GS0076-103
                                                                                no
All data requirements are current as of August, 1981.  Refer to the guidance package for updated requirements.   A
numerical bibliography  (MRID) is provided at the end of this Standard.

I/ Although customarily required, the Agency is prepared to waive the data requirement for a Subchronic  21-day dermal
   toxicity test on the manufacturing-use product.  This waiver is based upon the absence of observable  chronic  effects
   in any of the chronic studies which have been made available for Agency review, and upon the availability of  a
   subchronic 21-day dermal toxicity test conducted utilizing the 64% end-use product.  This latter study provides  no
   evidence of any chronic effect ensuing from repeated dermal exposure.

2/ As noted within Chapter VI, the available subchronic inhalation study fails to meet the duration requirement  established
   under section 163.82-4(c)(5).  The Agency, however, is prepared to waive the submission of additional subchronic inhalation
   toxicity data.  The Agency has determined that although the pattern of chemical use will lead to some inhalational exposure to
   spray mist, such exposure will be limited.  The Agency additionally finds no pattern of chronic effects  have  been established  in
   response to the review of other available chronic data.

3/ The Agency, based upon its review of available acute delayed neurotoxicity data, finds that the criteria established under
   163.82-5(a)(1) and (2) have not been met.  Due to the negative findings of the acute delayed neurotoxicity
   study in relation to both neuropathy and delayed neurotoxicity, the Agency will not impose a subchronic  neurotoxicity
   data requirement.
                                                                     24

-------
                                                       Table A:   Sulprofos
                                          Generic Data Requirements:   Toxicology (Chapter VI)
Guidelines
Citation
163.83-1
Name of Test
Chronic Feeding
Study
Are Data
Required?
yes
Composition
Technical Grade of
Active Ingredient
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
yes
Bibliographic
Citation
GS0076-114
Must Additional Data
be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
no
163.83-2
163.83-3
163.83-4
-
163.85-1
Oncogenicity
Teratogenicity
Reproduction
Mutagenicity
Metabolism
yes
yes
yes
yes
yes
Tech.
Tech.
Tech.
Tech.
Tech.
Grade
Grade
Grade
Grade
Grade
of
of
of
of
of
A.
A.
A.
A.
A.
I.
I.
I.
I.
I.
yes
partial
partial
partial-
yes
GS0076-115,-117
GS0076-141
GS0076-095
GS-0076-140
GS-0076-032
no
yes*/
no
yes/14
no



no.2/

All data requirements are current as of August,  1981.   Refer to the guidance package  for updated requirements.  A
numerical bibliography (MRID)  is provided at the end of this Standard.

I/  As provided under section  163.83-3(b)(2) teratogenicity testing "shall  be performed  in at  least  two mammalian species.
    The rat, mouse,  hamster, or rabbit is acceptable.   Other species may be used  if adequate justification  is supplied.
    One species should be the  same as the species used in the reproduction  study  (section 163.83-4)."  The  above-cited
    teratogenicity study, while acceptable,  must be supplemented by a confirmatory second study.  As the submitted study
    investigated the teratogenic potential of sulprofos in relation to  rabbits, the Agency would prefer that the  outstanding
    study be conducted utilizing the laboratory rat.
2/ The following studies represent only the  minimum requirements for data on the  potential heritable effects of sulprofos:
   1.  A mammalian in-vitro point mutation test.
   2.  A sensitive sub-mammalian point mutation test. (Bacteria, fungi,  insect).
   3.  A primary DMA  damage test (i.e. sister chromatid exchange or unscheduled DMA synthesis).
   4.  A mammalian in-vitro cytogenetics test.  If this test suggests a  positive result,  a dominant lethal or
       heritable translocation  test may be required.
After  results  from these test  systems and other toxicology disciplines  have been  considered, additional testing may
be required to further characterize or quantify the potential genetic risks.

Although the Agency's mutagenic testing requirements are not final, the standards for these tests should be based on  the
principles set forth in 43 FR  37388.  Protocols and choices of test systems should be accompanied by a scientific
rationale.  Substitutions of test systems for those listed above will be considered after discussion with the Agency.

The requirements should be considered an interim guide and not final Agency policy.   However,  the Agency does consider
the above testing scheme to be a reasonable  minimum requirement.

As the  submitted study involved a negative dominant lethal assay, the Agency will consider the requirement  for a  mammalian  in-vitro
cytogenetics test to have been fulfilled.
                                                                     25

-------
                                                      Table A:  Sulprofos
                                 Generic Data Requirements:  Residue - Chemistry (Chapter VII)
Guidelines
Citation
Name bf Test
Are Data
Required?
Composition
                                                          Does EPA Have Data
                                                          to Partially or
                                                          Totally Satisfy
                                                          this Requirement?
Bibliographic
Citation
Must Additional Data
be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
             Metabolism in Plants

             Metabolism in Animals


             Analytical Methods



             Residue Data: Crop
                           yes

                           yes


                           yes



                           yes
                                          yes

                                          yes


                                          yes



                                          yes
             Residue Data: Meat,
             Milk and Eggs
             Storage Stability
                           yes
                           yes
                                          yes
                                          yes
                                        GS0076-034               no

                                        GS0076,-078,-083,         no
                                        -093,-099,-168

                                        GS0076-022,-039,          no
                                        -072,-074,-076,-159,
                                        -169,-172,-174,-175

                                        GS0076-027,-028,          no
                                        -036,-044,-045,-046,
                                        -047,-048,-049,-050,
                                        -051,-052,-053,-054,
                                        -055,-077,-096,-147,
                                        -148 ,-155,-162,-170,
                                        -171,-176,-182

                                         GS0076-037,-038,         no
                                         -040,-041,-043,-146,
                                         -155

                                         GS0076-020,-021,         no
                                         -023,-166
All data requirements are current as of August, 1981.  Refer to the guidance package for updated requirements.
numerical bibliography (MRID) is provided at the end of this Standard.
                                                                                                 A
                                                                     26

-------
Guidelines
Citation
                                                           Table A: Sulprofos
                                   Generic Data Requirements:  Ecological Effects (Chapter VIII)
Name of Test
 Are Data
 Required?
Composition
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
  Bibliographic
  Citation
Must Additional Data
be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?	
163.71-1
Avian Single-Dose Oral LD5Q  yes
               Tech.
                                                                               yes
                                      GS0076-081,-119
                                                                                                                      no
 163.71-2

 163.71-3

 163.71-4

 163.71-5


 163.72-1
Avian Dietary LC50           yes

Mammalian Acute Toxicity     no-

Avian Reproduction           yes

Simulated and Actual Field   yes
Testing for Mammals & Birds
Fish Acute LC
                             50
Reserved-
Tech.



Tech.

Tech.


Tech.
     yes



     yes

     no


     partial
                                                     GS0076-120
                                                     GS0076-082,-185
GS0076-138,-163
                        no

                        no

                        no
                                                                                       2/
                                                                             yes/16 no.—
      yes/16 mo.
All data requirements are current as of August, 1981.  Refer to the guidance package for updated requirements.
numerical bibliography (MRID)  is provided at the end of this Standard.
                                                                                                 A
I/ The  Agency shall waive the requirement for the acute testing of mamalian species indigenous to potential
   sites of  application.   This waiver is predicated upon acceptable toxicity ranges established  as a result of
   those mamalian studies conducted in compliance with human and domestic animal toxicity guideline requirements.

_2/ Field testing  for avian species are required.   The eight-day, dietary DC™ to bobwhite quail has been established
~~  at 99 ppm.   This LCcn  falls below Agency calculated worst-case feed residue levels.

_3/ Although  the submitted fish acute LC50 studies have provided supplemental data useful in establishing the acute toxicity
~~  of sulprofos to fish,  the data have Been judged inadequate due to insufficient quantities of solubilized test substance.
   The  Agency additionally retains a concern that certain degradation products, principally sulfoxide, may possess
   greater solubility than the parent compound and hence, may move more readily into aquatic environments.  The Agency will
   require,  within the time interval noted above, fish acute LC^n studies on parent sulprofos.  The Agency will, however, reserve,
   pending the development of those adsorption/desorption data requested under the Environmental Fate portion of this Chapter, a
   determination  as to any additional acute toxicity requirements related to the degradation products.
                                                                     27

-------
                                                           Table A:  Sulprofos
                                   Generic Data Requirements:   Ecological  Effects  (Chapter VIII)
Guidelines
Citation
163.72-2
163.72-4
163.72-6
163.122-1
163.122-1
163.122-2
163.122-2
Name of Test
Acute Toxicity to Aquatic
Invertebrates
Embryolarvae & Life-
cycle Studies of Fish &
Aquatic Invertebrates
Simulated or Actual
Field Testing for
Aquatic Organisms
Vegetative Vigor
Seed Germination
Aquatic Macrophyte
Algae
Are Data Composition
Required?
yes Tech .
Reserved-'
Reserved— -
yes Tech.
yes Tech .
yes Tech .
yes Tech.
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
yes
-
-
no
no
no
no
Bibliographic Must Additional Data
Citation be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
GS0076-160,-164 no
reserved—/
reserved—'
yes/16 mo.
yes/16 mo.
yes/16 mo.
yes/16 mo.
All data requirements are current as of August,  1981.   Refer to the  guidance package for updated requirements.   A
numerical bibliography  (MRID) is provided at  the end of this Standard.

V The Agency will reserve a determination  as to the necessity of these studies  pending receipt and evaluation of the
   adsorption/desorption data requested elsewhere within this chapter.
                                                                     28

-------
                  Product Specific Manufacturing Use
Table B:  Sulprofos
Products Data Requirements:  Product Chemistry (See Chapter IV)
Guidelines
Citation
163.61-3


163.61-4


163.61-5



163.61-6


163.61-7

163.61-8(c)(l)

163.61-8(c)(2)
163.61-8(c) (3)
Name of Test
Product Identity
& Disclosure of
Ingredients
Description of
Manufacturing
Process
Discussion on
Formation of
Unintentional
Ingredients
Declaration &
Certification of
Ingredients Limits
Product Analytical
Methods & Data
Color

Odor
Melting Point
Are Data
Required?
yes


yes


yes



yes


yes

yes

yes
yes
Composition
Each Product


Each Product


Each Product



Each Product


Each Product

Technical Grade of
Active Ingredient
Tech. Grade of A.I
Tech. Grade of A.I
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
yes


yes


yes



no


yes

yes

yes
yes
Bibliographic Must Additional Data
Citation be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
yesi/


yesi/


yes*/



yesi/


GS0076-149 no

yesi/

yesi/
yesi/
These data  requirements are current as of August,  1981.   Refer to the guidance  package  for  updated requirements.
A numerical bibliography (MRID)  is provided  at the end of this Standard.

I/ These  requirements must be fulfilled by each applicant.   Data from other applicants  may  not be cited.  Therefore, even if
~  the requirements have been partially or completely fulfiled for some products,  no references  are given.   Except  for
   163.61-7,  these  requirements  must be filled at  the time of  registration or reregistration.
                                                                     29

-------
                                                        Table B:  Sulprofos
                  Product Specific Manufacturing Use Products Data Requirements:  Product Chemistry  (See Chapter  IV)
Guidelines
Citation
163
163
163
163
163
163
163
163
.61-8(c)
.61-8(c)
.61-8(c)
.61-8(c)
.61-8(c)
.61-8(c)
.61-8(c)
.61-8(c)
Name of Test Are Data
Required?
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
Solubility yes
Stability yes
Cctanol/Water Partition yes
Coefficient
Physical State yes
Specific Gravity yes
Boiling Point no
Vapor Pressure yes
pH yes
Composition Does EPA Have Data Bibliographic
to Partially or Citation
Totally Satisfy
this Requirement?
Tech. Grade of yes
Active Ingredient
Tech.
Tech.
Tech.
Tech.
Tech.
Tech.
Tech.
Grade
Grade
Grade
Grade
Grade
Grade
Grade
of A.I. yes
of A.I. no
of A.I. yes
of A.I. yes -
of A.I. yes
of A.I. yes
of A.I. no
Must Additional Data
be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
yesi/
yes—
yesi/
yesA/
yesi/
yesi/
yes—
yesi/
These data requirements are current as of August, 1981.  Refer to the guidance package for updated requirements.
A numerical bibliography (MRID) is provided at the end of this Standard.

I/  These requirements must be fulfilled by each applicant.  Data from other applicants may not  be cited.   Therefore,  even if the
    requirement has been partially or completely fulfilled for some products.  No references  are given.   Except for 163.61-7,
    these requirements must be filled at the time of registration or reregistration.
                                                                       30

-------
                                                       Table B:  Sulprofos
                 Product Specific Manufacturing Use Products Data Requirements:   Product  Chemistry (See  Chapter IV)
Guidelines
Citation
163.61-8(c)(12)
163.61-8(c)(13)
163.61-8(c)(14)
163.61-8(c)(15)
163.61-8(c)(16)
163.61-8(c)(17)
163.61-8(c)(18)
Name of Test Are Data
Required?
Storage Stability
Flammability
Oxidizing/Reducing
Action
Explos iveness
Miscibility
Viscosity Coefficient
Corros iveness
yes
yes
yes
yes
yes
yes
yes
Composition Does EPA Have Data Bibliographic Must Additional Data
to Partially or Citation be Submitted Under
Totally Satisfy FIFRA 3(c)(2)(B)7
this Requirement? If so, due when?
Each Product
Each Product
Each Product
Each Product
Each Product
Each Product
Each Product
yes
no
no
no
yes
yes -
no -
yes!/
yes/6 mo.—
yes/6 mo.—
yes/6 mo.!/
yesi/
yesV
yes/6 mo.—
These data requirements are current  as of August,  1981.  Refer  to the guidance package for updated requirements.
A numerical bibliography  (MRID)  is provided at  the end of  this  Standard.

I/  These requirements must be fulfilled by each applicant.  Data from other applicants may not be cited.  Therefore, even if  the
    requirement has been partially or completely fulfilled for  some products, no references are given.  Except  for  163.61-7,
    these requirements must be filled at the time  of registration or reregistration.
                                                                       31

-------
                                                        Table C:   Sulprofos
                     Product Specific End-Use Products Data Requirements:   Product Chemistry (See Chapter IV)
Guidelines
Citation
163.61-3
163.61-4
Name of Test
Product Identity
& Disclosure of
Ingredients
Description of
Are Data
Required?
yes
yes
Composition
Each Product
Each Product
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
yes
yes
Bibliographic Must Additional Data
Citation be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
yesi/
yesi/
                Manufacturing
                Process

 163.61-5        Discussion on          yes
                Formation  of
                Unintent ional
                Ingredients

 163.61-6        Declaration &          yes
                Certification  of
                Ingredients Limits

 163.61-7        Product Analytical    yes
                Methods &  Data
Each Product
Each Product
Each Product
                        no
                        no
                        yes
GS0076-150
                                                                yes
                       yesi/
                                                                no
These data requirements are current  as  of August,  1981.   Refer to the guidance package for updated requirements.
A numerical bibliography  (MRID)  is provided  at the end of this Standard.

I/  These requirements must be  fulfilled  by  each applicant.   Data from other applicants may not be cited.  Therefore, even if the
~~   requirement has been partially or completely fulfilled for some products,  no references are given.  Except for 163.61-7,
    these requirements must be  filled at  the time  of registration or reregistration.
                                                                       32

-------
                                                 Table C:  Sulprofos
                 Product Specific End-Use Product Data Requirements: Product Chemistry  (See Chapter IV)
Guidelines
Citation
163.61-8(c)(l)
163.61-8(c)(2)
163.61-8(c)(7)
163.61-8(c)(8)
163.61-8,0(11
Name of Test
Color
Cdor
Physical State
Specific Gravity
) pH
Are Data
Required?
yes
yes
yes
yes
yes
Composition
Each Product
Each Product
Each Product
Each Product
Each Product
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
yes
yes
yes
yes
no
Bibliographic Must Additional Data
Citation be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
yesi/
yesi/
yesi/
yesi/
yes*/
These data requirements are current as of August, 1981.  Refer to the guidance package for updated requirements.
A numerical bibliography (MRID) is provided at the end of this Standard.

V  These requirements must be fulfilled by each applicant.  Data from other applicants may not be cited.  Therefore, even  if  the
    requirement has been partially or completely fulfilled for some products.  No references are given.  Except for  163.61-7,
    these requirements must be filled at the time of registration or reregistration.
                                                                       33

-------
                                                        Table  C:   Sulprofos
                    Product Specific  End-Use Product Data Requirements:   Product  Chemistry (See  Chapter IV)
Guidelines Name of Test
Citation
163.61-8(c)(12) Storage Stability
163.61-8(c)(13) Flammability
163.61-8(c)(14) Oxidizing/Reducing
Action
163. 61-8 (c)( 15) Explosiveness
163.61-8(c)(16) Miscibility
163.61-8(c)(17) Viscosity Coefficient
163.61-8(c)(18) Corrosiveness
Are Data
Required?
yes
yes
yes
yes
yes
yes
yes
Composition
Each Product
Each Product
Each Product
Each Product
Each Product
Each Product
Each Product
Does EPA Have Data
to Partially or
Totally Satisfy
this Requirement?
yes
yes
yes
yes
yes
yes
no
Bibliographic Must Additional Data
Citation be Submitted Under
FIFRA 3(c)(2)(B)?
If so, due when?
yes—
yesi/
yes-
yes—
yesi/
yesi/
yesi/
These data requirements are current  as of August,  1981.   Refer to the  guidance  package for updated requirements.
A numerical bibliography  (MRID)  is provided  at  the end of this Standard.

I/  These requirements must be  fulfilled by  each applicant.   Data from other applicants may not be cited.  Therefore, even if the
~   requirement has been partially or completely fulfilled for some  products, no references are given.   Except for 163.61-7,
    these requirements must be  filled at the time  of  registration or reregistration.
                                                                     34

-------
                                                   Table C:  Sulprofos
                      Product Specific End-Use Product Data Requirements: Toxicology (See Chapter VI)
Guidelines Name of Test Are Data
Citation Required?
163.81-1 Acute Oral Toxicity yes
163.81-2 Acute Dermal Toxicity yes
163.81-3 Acute Inhalation Toxicity yes
163.81-4 Primary Eye Irritation yes
163.81-5 Primary Dermal Irritation yes
163.81-6 Dermal Sensitization yes
Composition Does EPA Have Data Bibliographic Must Additional Data
to Partially or Citation be Submitted Under
Totally Satisfy FIFRA 3(c) (2) (B)?
this Requirement? If so, due when?
Each Product
or Substantially
Similar Product
Ea. Prod, or
Substan. Sim. Prod.
Ea. Prod, or
Substan. Sim. Prod.
*
Ea. Prod, or
Substan. Sim. Prod.
Ea. Prod, or
Substan. Sim. Prod.
Ea. Prod, or
Substan. Sim. Prod.
yes^ GS0076-127 no
yesi/ GS0076-123 no
yes^ GS0076-124 no
yes^ GS0076-129 no
yesi-7 GS0076-128 no
no - yes/9 mo.
All data  requirements are current as of August,  1981.   Refer to the guidance package for updated requirements.
A numerical  bibliography is provided at the end  of this Standard.

I/ The available  data are adequate in support of end-use products,  having a composition range of 64% or less
~  sulprofos in combination with 0 to 15% petroleum distillates as  the sole active ingredients.
                                                                     35

-------
                           IV. PRODUCT CHEMISTRY
     A.  Product Chemistry - Manufacturing-Use Products
     B.  Product Chemistry - End Use Products

A.  Product Chemistry ^ Manufacturing-Use Sulprofos


1.  Manufacturing Process

Sulprofos, 0-ethyl 0-[4-(methylthio)phenyl] S-propyl  phosphorodithioate, is an
insecticidal compound originated by the parent company Bayer AG,  Leverkusen,
West Germany with development by Chemagro Agricultural Division of Mobay
Chemical Corporation.  At the time of development of  this  Standard, only a
single manufacturing use (technical) product has been registered with the
Agency. A complete description of the process by which technical sulprofos is
manufactured has been provided to the Agency  (Mobay Chemical Corporation 1975,
MRID GS0076-149).  Details of this process, however,  are considered by the
Agency to be of trade secret information and, hence,  will  not  be provided
within this standard.  Related synthesis descriptions (for 0-ethyl-S-propyl-
dithiophosphoric acid phenyl or naphthyl esters) may  be found  under United
States Patent 3,947,529  (Kishino et al., 1974, MRID GS0076-104).

2.  Unintentional Ingredients

Technical sulprofos is approximately 90% pure.  Twenty-one impurities have been
isolated and are known to the Agency.  Like the manufacturing  process,  however,
the characterization of these impurities is considered trade secret.  It may be
stated that the majority of these impurities are related to organophosphate
compounds.  Three components remain unidentified, but, in  aggregate, account
for only 0.2% of the technical formulation.  No single compound comprises more
than 1.5% of the total formulation and only seven comprise more than 0.5% of
the technical material (Patel, 1976, MRID GS0076-165).  The Agency, in
considering the known impurities, does not believe that they singly or in
aggregate represent any potential hazard or are they  of significance in
establishing residue levels.

3.  Physical and Chemical Properties

A nearly complete range of data is available on the physical and chemical
properties of sulprofos.   Data which are not available, but which are required,
are listed within the Chapter III data charts.  Those data which are available
are as follows:
                                       36

-------
     Appearance


     Boiling point


     Odor


     Melting Point


     Hydrolysis rate



     Specific Gravity


     Solubility



     Viscosity


     Vapor Pressure


     Wt. per Gallon
Tan colored liquid
(Mobay Chemical Corp., 1975, MRID GS0076-150)

155 - 158° C @ 0.1 ram Hg
(Mobay Chemical Corp., 1975, MRID GS0076-152)

Typical phosphorous odor
(Mobay Chemical Corp., 1975, MRID GS0076-150)

<-50° C
(Mobay Chemical Corp., 1975, MRID GS0076-150)

@ 25° C and pH 7 - Half-life 6 months

-------
emulsifiable concentrate formulation containing 64 percent manufacturing-use
sulprofos, 15.0 percent petroleum distillate and 21 percent inert ingredients.
Complete details of the formulating process and inert constituents have been
made available to the agency (Mobay Chemical Corp., 1975, MRID GS0076-149;
Mobay Chemical Corp., 1975, MRID GS0076-150).  These items of data, like the
technical synthesis process, are trade secret and will not be described within
this Standard.

1.  Physical and Chemical Properties

Data are available describing the following physical and chemical properties of
Bolstar® 6:
     Appearance


     Explosiveness


     Flash Point



     Cdor


     Specific Gravity


     Solubility



     Vapor pressure


     Viscosity
     Wt. Active per
         Gallon

     Wt. per Gallon
Amber
(Mobay Chemical Corp., 1975, MRID GS0076-150)

No explosive characteristics
(Mobay Chemical Corp., 1975, MRID GS0076-152)

105° F (TCC)
125° F (TOC)
(Mobay Chemical Corp., 1975, MRID GS0076-150)

Typical phosphorus odor
(Mobay Chemical Corp., 1975, MRID GS0076-150)t

1.11 @ 20° C
(Mobay Chemical Corp., 1975, MRID GS0076-150)

Miscible with HAN solvents - not miscible with
kerosenes or diesel oils
(Mobay Chemical Corp., 1975, MRID GS0076-150)
   •
<5 mm Hg @ 20° C
(Mobay Chemical Corp., 1975, MRID GS0076-152)

45 cps @ 30° F
20 cps @ 60° F
(Mobay Chemical Corp., 1975, MRID GS0076-152)

6 Ibs.
(Mobay Chemical Corp., 1975, MRID GS0076-150)

9.27 Ibs.
(Mobay Chemical Corp., 1975, MRID GS0076-152)
                                      38

-------
2.  Storage Stability

Like technical sulprofos, Bolstar® 6 has been evaluated as to  its storage
stability.  No change in emulsification characteristics, physical or chemical
properties were observed following eight weeks at 50  C and 24 weeks at
40  C (McGreavy et al., 1975, MRID GS0076-142 and Synek and Gonzalez,  1975,
MRID GS0076-178).  It was noted that some decoating and corrosion occured when
the test material was placed  in double clear phenolic-coated steel pails.  No
corrosion was observed in pails having pigmented vinyl phenolic coatings.
                                       39

-------
                           V.  ENVIRONMENTAL FATE
     A.  Use Profile
     B.  Environmental Fate Profile
A.  Use Profile

Sulprofos is a broad spectrum organophosphate insecticide/acaracide
conditionally registered on February 14, 1979, for control of tobacco  budworm,
cotton bollworm, lygus nymphs, fall armyworm, beet armyworm, pink  bollworm
and fleahoppers on cotton.  In addition, the labeling for Bolstar® 6,  the  only
registered end use product, bears claims for suppression of lygus  adults,
whiteflies, and spider mites (Carmine and two-spotted).

Bolstar® 6 is formulated as a 64 percent sulprofos emulsifiable  concentrate
containing 15 percent aromatic petroleum distillate and 21 percent inert
ingredients.  Application may be made, at the specified dosage,  by either  air
or ground equipment.  The concentrate is to be diluted with that amount of
water required to ensure complete foliar coverage.  Aerial applications may
not, however, be made at dilutions of less than 1 gallon per acre.   Application
rates for all states other than California and Arizona vary by target  pest and
infestation level; falling within a range of 2/3 to 2 pints of undiluted
formulation per acre (equivalent to 0.5 to 1.5 Ibs. active sulprofos). Use
directions specific to Arizona and California prescribe a minimum  application
rate of 1-1/3 pint .(1 lb. active ingredient) per acre and a maximum  rate of
2 pints.  Applications, without regard to geographical region, may be  made at
three to seven day intervals.  Total application is restricted to  20 pints per
acre/season with the last application no closer to harvest than  21 days in
California and Arizona, or 14 days in all other states.

Use and usage data relating to sulprofos are limited due to its  recent
appearance in the marketplace.  Although there are no formal survey  data
available regarding predominate application rates, preliminary information
provided by Mississippi State University (Preliminary Benefits Analysis:
EPN/Cotton 1981, MRID GS0076-184) indicates that sulprofos is commonly
applied at the rate of 1.0 Ibs. a.i. per acre for control of the Heliothis
complex.  Based upon an assumed average application of 1.0 lb. per acre, the
Agency estimates that a 1980 usage of 813,800 pounds a.i.  (Weiler, E., 1981,
MRID GS0076-183).
                                      40

-------
B.  Environmental Fate Profile

1.  Hydrolysis

Sulprofos is considered to be relatively  stable  in  acidic  and  neutral  aqueous
buffer solutions.   In an aqueous buffer solution at pH  3 and at  40° C,
sulprofos hydrolyzed to phenol sulfoxide  (0.5 percent)  and sulprofos
sulfoxide (4.8 percent) in 16 days.  At pH-7 and at 40° C, only  8 percent of
the test sulprofos  had hydrolyzed and/or  oxidized within 16 days; the
products being phenol sulfoxide  (0.8 percent) and sulprofos sulfoxide  (7.2
percent) (Bull, D.L. et al., 1975, MRID GS0076-034).

Sulprofos may be considered  unstable when subjected to  basic buffer solutions.
In an aqueous buffer solution at pH-11 and at 40° C,  sulprofos was  more  than
50 percent hydrolyzed in four to eight days.  The hydrolysis products  were
phenol sulfoxide (35.8 percent), phenol sulfide  (32.0 percent) and  sulprofos
sulfoxide (3.2 percent) (Bull, D.L. et al., 1975, MRID  GS0076-034).

In a simulated pond study, sulprofos was  half degraded  in  approximately  two
hours and completly degraded in four days.  At the  fourth  day, the  degradation
products were:  phenol sulfoxide  (54.7 percent), sulprofos sulfoxide (14.4
percent), phenol sulfone  (0.6 percent), and 9.4  percent unidentified.  Further
conversion of degradation products occurred.  At day  16, the degradation
products were, phenol sulfoxide, 66.9 percent, sulprofos sulfoxide,  1.4
percent, and unidentified products comprised 12.1 percent  (Bull, D.L., et al.
1975, MRID GS0076-034).

From these data, the Agency  may  conclude  that sulprofos, upon  finding  its way
into aquatic environments through either  leaching,  runoff  or inadvertent
application, may degrade  fairly  rapidly.   Che of the  principal
products, however,  is noted  as being a cholinesterase (ChE) inhibitor.   The
significance of these findings,  shall be  addressed  in relation to the  potential
for sulprofos to enter aquatic environments.

2.  Photodegradation

   (a)  Aqueous

       In an aqueous phosphate buffer solution  (pH-7),  sulprofos was 1/2-
       photolyzed  in seven hours  at  20° C. Photolysis  slowed  at 5   C, with
       36 hours being required before reaching 1/2.  The principal  photo
       product was the P=<3 sulfoxide  (PSSO) which accounted  for  approximately
                                       41

-------
     22  and  18 percent of the  activity at day-3 at 20  C and 5° C
     respectively.   At day-3,  approximately 1 percent of the activity
     was P=S sulfone (PSSO ) and  about 2 percent of the activity was
     parent  phenol    at both temperatures.  Ihe remaining activity, which
     amounted to approximately 13 percent at 20  C and 7 percent at
     5°  C, was unidentified (Atwell and Gronberg 1975, MRID GS0076-026).

(b)   Soil

     The photodecomposition half-life of sulprofos at 20  C has been
     extrapolated to be approximately 12 days on gilty loam soil.
     Photodecomposition proceeds  more slowly at 5  C, with the
     extrapolated half-life not occurring for approximately 32 days.  In
     silty loam  at 20  C, the  major photo product and or metabolite (PSSO),
     accounted for approximately  68 percent of the activity at 28 days.   At
     5°  C,  approximately 63 percent of the activity was PSSO.

     The photodegradative half-life of sulprofos on sandy loam at 20  C has
     been extrapolated to be 12 days.  At 5  C, the half-life has been
     extrapolated to be 15 days.   At 20° the major oxidative product, PSSO,
     accounted for 62 percent  of  the noted activity at 28 days and was
     slightly decreasing at this  time.  When observed at 5  C, PSSO,
     accounted for approximately  78 percent of the noted activity at 28 days.

     In  silty loam, at 20 and  5°  C and in the absence of light, sulprofos
     under went  oxidation to PSSO at approximately 22 percent and 18 percent
     respectively within 28 days. In sandy loam, oxidation to PSSO was
     approximately 28% for both temperatures (Atwell and Gronberg, 1975, MRID
     GS0076-026).

(c)   Glass Surface

     On  glass surfaces, at 20  C,  sulprofos photodecomposed with a half-life
     of  approximately 19 hours.   P=^3 sulfoxide, the major photolysis product
     was about 25 percent (maximal) of the activity at 2 days and declined to
     approximately 5 percent of activity at 14 days.  Approximately 60
     percent activity was unaccounted for at 14 days (Atwell and Gronberg,
     1975,  MRID  GS0076-026).

     At  5  C, the half-life of sulprofos was approximately 63 hours.  P=S
     sulfoxide,  the major photolysis product reached maximal, approximately
     30  percent  of the activity,  at 5 days.  The P=S sulfoxide was
     approximately 5 percent of the activity in 14 days, with approximately
     30  percent  of the activity unaccounted for after 14 days.  The loss of
     applied activity throughout  the 14 days suggests that the photolysis
     products may be volatilized  from glass surfaces.
                                    42

-------
  (d)  Silica Gel Surface

       Sulprofos was 1/2-photolyzed in approximately one hour on silica gel
       surfaces.  The primary photoproduct was the P=S sulfoxide (PSSO) which
       reached a maxima of 77 percent of the activity in 6 hours, then
       proceeded to decline to 69 percent of the activity in 24 hours.  The
       minor photoproducts were the P=S sulfone (PSSCL), parent phenol (PS)
       and phenol sulfoxide (PSO).  Sixteen percent of the activity was
       unidentified after 24 hours.

       The rate of photodegradation was slower at 5° C.  The half-life was
       approximately 2 hours.  P=S sulfoxide (PSSO) was the major photo
       product, accounting for 76 percent of the activity after 24 hours.
       Minor photo products were observed.  Approximately 17 percent of the
       activity was unidentified.

       In the absence of light, sulprofos was stable on silica gel surfaces at
       both 5 and 20° C (Atwell and Gronberg, 1975, MRID GS0076-026).

Given the preceding data, the Agency concludes that sulprofos may be
anticipated to undergo fairly rapid photodegradation with the principal
photodegradate product being P=S sulfoxide.

3.  Aerobic Soil Metabolism

Under aerobic soil conditions, sulprofos degrades fairly rapidly.  The
extrapolated half-life in loam, sandy soil of construction sand ranges from one
to four weeks.  The half-life appears greatest (near four weeks) in loam.
Three major metabolites have been identified.  These metabolites are sulprofos
sulfoxide, sulprofos sulfone, and phenol sulfoxide  (unique to construction
sand).  These major metabolites are reasonably long lived with a  >^ 128 day
half-life.  Trace amounts (1-2 percent of applied activity) of O-analog
sulfoxide, O-analog sulfone, phenol sulfoxide are also present without regard
to soil type.  Unextractable residues account for 10-25 percnt  of applied
activity at approximately 170 days.  loam soils produce more sulprofos
sulfoxide than sandy soils.  The presence of organic matter, the oxygen content
of the soil and pH are major factors in the degradation of sulprofos.
Degradation appears, however, to be via physicochemical pathways with
biological degradation not a major contributor (Pither, 1978, MRID GS0076-167)

From the review of available data, the Agency has concluded that sulprofos may
be anticipated to degrade fairly rapidly under most aerobic soil conditions.
In light of the pattern of use under consideration, aerial or ground
application not to include soil incorporation, it may be anticipated  that the
majority of the applied sulprofos parent reaching the soil will be degraded via
physicochemical pathways in the manner described above.
                                      43

-------
4.  Anaerobic Soil Metabolism

Under anaerobic conditions, degradation proceeds in a manner similar  to that
observed under aerobic conditions with the exception that the degradative
process occurs much more slowly.  The extrapolated half-life for sulprofos
under anaerobic soil conditions is approximately 20-30 weeks (Bull et al. 1975,
MRID GS0076-034).

5.  Microbial Degradation

Few groups of microbes appear to possess the ability to degrade sulprofos.   Of
those that have demonstrated the ability to affect degradation, it appears  that
they may do so only in small amounts.  Bacteria and Streptomyces have a
potential to degrade sulprofos, while fungi have demonstrated no degradative
activity  (although incorporation into the mycelia is reported)  (McNamara, F.T.,
1978, MRID GS0076-143).

6.  Metabolism ^ Effect of Sulprofos on Microbes

Representative species of bacteria, fungi, and Streptomyces  (Bacillis ,
Cellulomonas  , Pseudomonas , Streptomyces , Aspergillus  , Penicillium ,
Tricoderma , and Phycomyces  spp. have been evaluated against 2-10  ppm
concentrations of sulprofos  (LaBlanc, B., et al., 1975, MRID GS0076-108).   No
inhibition of any organism has been demonstrated at concentrations of less  than
10 ppm.  Fungi, when exposed at 10 ppm exhibit slight inhibition, with  marked
inhibition occuring at 100 ppm.  Bacteria, Streptomyces and Tricoderma   were
not inhibited at the highest concentration tested.

Nitrification and denitrification potentials in loamy sand soil do not  show
any effect at either IX or 10X labeled rates of application  (Strankowski, K.J.,
1978, MRID GS0076-177).

Nitrogen  fixation, as measured by studies involving the symbiotic relationship
between Rhyobium and soybeans, appears markedly reduced at four weeks (67%).
This reduction indicates a potential break in the nitrogen cycle and/or
increased persistence.  The limits of the test method appear to preclude
distinguishing whether the observed effect is related to an effect upon the
plant or the microbe (Strankowski, K.J., 1978, MRID GS0076-177).

The Agency may conclude from reviewed studies that application of sulprofos
at rates of 0.5 to 1.5 Ib. a.i./A would not be anticipated to affect
discernable alterations in soil microbe populations.  Given, however, an
indication of a significant reduction in nitrogen fixation, some measure of
concern must remain.  In this latter regard, the Agency believes that observed
effects may have resulted from an effect not directly related to Rhyobium
inhibition.  The Agency would, therefore, propose a reinvestigation with
provision made for an observation of effects to both symbiots.  A reevaluation
                                       44

-------
of sulprofos's impact upon nitrogen fixation shall not be  imposed as a
condition of its registration  for cotton  application.  Should,  however,  future
registration s) be sought for  crops for which nitrogen fixation is an important
factor (primarily legumes), the Agency may require a reinvestigation.

7.  Plant Metabolism  (Dislodgable Residues)

Approximately 50% of 14C or 32P labeled sulprofos, when  applied to cotton
leaves is absorbed within 24 hours.  While residues  can  be recovered from
treated leaves throughout either 16 or 32 day studies, all compounds are
essentially depleted in 8 days.  Compounds recovered from  leaf  surfaces  and
their percent of applied dose  at 8 days are as  follows:   (1)  sulprofos  parent
(0.0%), (2)  sulprofos sulfoxide (0.2  percent),  (3)  sulprofos  sulfone  (0.2
percent)  (4) O-Analogue sulfone  (0.0 percent),  (5)   Phenol sulfoxide  (0.0
percent)  Phenol sulfone  (0.1  percent),  (7)  unknown (0.7  percent).  Studies
have provided that at day one  these residues were 2.2, 13.7,  4.1, 0.2, 0.8,
0.7, and  3.9 percent respectively.  Internal extracts of treated leaves  have
been found to include the same radioactive compounds as  in the  external  rinses
plus water solubles, unextractables, and  lost activity (Bull  and Whitten,  1975,
MRID GS0076-034).

8.  leaching

Sulprofos, when evaluated with respect to its leaching ability, (Atwell  and
Gronberg, 1975, MRID GS0076-025),  (Atwell and Gronberg,  1975  MRID GS0076-024)
was found to be largely retained within the upper two inches
(about 95%) in muck, loam and  silty loam  soil.   It was found  mobile in sandy
loam.  As organic matter content of soil  decreases and pH  increases, leaching
of sulprofos may be expected to  increase.  In thin layer mobility studies,
sulprofos was found to leach very  little  in agricultural sand,  sandy loam,
sandy clay loam, silt loam and two silty  clay soils. In an aged soil study,
approximately 90 percent of aged soil  degradates were distributed in the upper
four inches of a loam soil column, with about 8.8 percent  occurring in the
leachate as sulprofos phenol sulfone.  This indicates that in basic soils,
leaching of the phenol sulfone may be  significant in sandy loam or soil  with
low organic matter.

From the evaluated data, the Agency may conclude that sulprofos parent and
certain of its degradates may  leach in sandy soils.  There is additionally
evidence  that some movement of degradation products  can  occur in other soil
types.  The reasonably insoluble nature of the  parent compound  (0.03
ppm) (Mobay Chemical Corp., 1975, MRID GS0076-150),  and  an Agency calculated
soil/water partition coefficient of 69 leads the Agency  not to  believe that
movement of sulprofos per se is of immediate concern.  Due to the single
pattern of use under consideration within this  standard  being application to
cotton, the Agency, further, does not  believe that the indicated potential for
leaching  in sandy soil is of significance, because cotton  is  not customarily
                                       45

-------
cultivated in sandy soil types.  A full understanding of  the potential  for
movement from treated areas into aquatic systems, however,  can not be developed
until such time as the Agency may obtain and evaluate adsorption/desorption
data for both parent sulprofos and its principal degradation products.   A
reconsideration of the significance of sulprofos's leaching potential will be
conducted upon receipt of these data.  The Agency will  additionally reconsider
the significance of sulprofos's leaching potential should sandy soil cultivated
crops such as citrus, peanuts, etc. be proposed  for  future  lableing
consideration.

9.  Runoff

Data available for Agency review have indicated  that residue in runoff  water
was, under the conditions of the test, generally less than  10  percent
(0.3 ppm) of the applied active on sandy loam, loam  and clay loam for 8 and 12
ft. lanes.  Approximately 25 percent  (0.75 ppm) runoff  occurred for loam soil
in 6 ft. lanes (Kurtz and Gronberg, 1975, MRID GS0076-106).

The principal oxidative product found in the runoff  water was  sulprofos
sulfoxide (amounting to 67-70 percent of the residue).  Sulprofos sulfone and
sulprofos oxygen analog sulfoxide residues ranged from  8-23 percent. Small
amounts (2 percent or less) of sulprofos parent  and  sulprofos  oxygen analog
sulfone were detected in runoff water.

As with leaching, the Agency considers soil runoff to be  one of the principal
mechanisms by which pesticides may move from treated crop areas into aquatic
environments.  Those data reviewed by the Agency have indicated that sulprofos
and its degradates possess a limited potential for movement by means of
runoff.  The Agency, however, again believes that a  full  understanding  of
sulprofos's runoff potential cannot be obtained until such  time as the
Agency may review adsorption/desorption data.  With  these data, the Agency will
be in a position to provide a calculated estimated environmental concentration
(EEC).

10.  Field Dissipation

In test data reviewed by the Agency, combined residues  of 2.45 ppm and  1.92 ppm
persisted for 242 days in clay loam and loam respectively from 3 sucessive
applications (2.5 ppm) at 30-day intervals.  Combined residues in sand  were
approximately 2.5 times the application rate at  72 days.  In muck, combined
residues were more than 14 times the theoretical value  (2.5 ppm) at 72  days.
The data show, however, that the photodegradative half-life of sulprofos on
soil surfaces of four different soil types was 12 to 32 days  (Chemonics
Industries, 1978, MRID GS0076-056, -057, -058, -059).   From these data, the
Agency may deduce that soil incorporation of sulprofos  would provide for
greater field persistence.  As some portion of the applied  sulprofos would be
intercepted by the cotton plants and crop uptake studies  under actual use
                                       46

-------
conditions show that combined soil residues at harvest  range  from 0.03 to
0.35 ppm for 15 to 18 applications at  2.5  to  3.25  Ib/A,  the Agency believes
that soil residues resulting from sulprofos application to cotton would be
within acceptable limits.

Although the Agency has determined that those data derived from muck soil
testing are inadequate, the Agency will not,  for the  current  use pattern,
require additional data.  Should future registration  actions  involve crops
customarily grown in muck soil, the Agency will require acceptable muck soil
persistence data as a condition of registration.

11.  Bioaccumulation

The bioaccumulation potential of sulprofos has been investigated in a study
involving channel catfish  (Lamb and Roney, 1975, MRID GS0076-139).   The
fish, exposed at 10 ppb through a 28 day period, were sacrificed and analyzed
for residue content and physical location  of  residues within  the body.
Accumulation factors for whole fish were,|rom 704  to  1006 (2816 to 4025 ppb).
Approximately 88 percent of extractable   C residues  were contained in the
nonedible portion and 12 percent in the edible portion  on.day 28 of exposure
(3287 ppb in non-edible and 448 ppb in edible).  Of the  C residue in non-
edible polar extract, 21 percent was identified as sulprofos  parent.   The
remaining residue was identifed as Sulfoxide  (PSS) (44  percent), Sulfone
(PSSO  )  (2 percent), and Oxygen Analog Sulfoxide  (POSO) (1.0  percent).  An
additional 17 percent of the identifiable  activity was  accounted for as
Sulfoxide and Sulfone phenols.  Approximately 17 percent of the total activity
was unidentified.
                                                          14
During withdrawal, approximately half  of the  accumulated  C  residue in the
catfish was eliminated within  5 hours.  This  rapid elimination tends to
indicate that most of the residues were on the scales or in viscera and not in
edible tissue.  Following 28 days of withdrawal, 112  ppb of residue was
detected in whole body analysis.

The preceding study, although not conducted  in strict accord  with the Agency
Guidelines protocol, has been deemed acceptable.   Given the rapid degradation
of sulprofos (refer to the above noted simulated pond study), the rate of
elimination of residues from catfish when  placed in pesticide free water, and
the dilution of residue in water, the  Agency does  not expect  that residues  of
sulprofos would persist for a sufficient period of time to result in
accumulation in fish.

12. Accumulation;  Rotational Crop Uptake

Although no petitions for tolerance for rotational crops are  pending with the
Agency, some data are available.  These data provide  that for sugar beets 164
days after last application  (285 days  planting to  harvest) residues were
                                       47

-------
0.016 ppm in the roots, 0.008 ppm in the tops and 0.36ppm in  (0-6") soil  layer.
A second study conducted on sugar beets provided results indicating the
presence of residues 365 days following the .last application  (174 days planting
to harvest).  These residues were identified at levels of 0.009 ppm in the
roots, 0.005 ppm in the tops and 0.29 ppm in the soil  (Sandi, F.E., 1978, MRID
GS0076-173).

Studies conducted on rotational wheat similarly reveal the presence of
residues.  Wheat planted 164 days following last application  (170 days planting
to harvest) yielded residue levels of 0.017 ppm in  the,grain, 0.044 ppm  in  the
chaff, 0.047 ppm in the stalk and 0.121 ppm sulprofos   C-equivalent  in  the
forage.  Wheat planted 365 days following the last  application  (174 days
planting to harvest) contained residue levels of 0.036 ppm in the forage.   At
125 and 66 days planting to harvest residues were 0.088 and 0.126 respectively
(Sandi, F.E. 1978, MRID GS0076-173).

Residues in potato tubers planted 131, 203, 197, and 173 days after last
application (as ppm sulprofos equivalents) in Georgia, Texas  (1), Mississippi,
Florida, were all <0.01 ppm.  Texas (2) had a residue value of 0.01 ppm  at  203
days.  Soil residues (0-6" depth) at planting and harvest were 0.72,  0.15;
0.36, 0.14; 0.03, 0.35; 0.28, 0.15; 0.01, 0.03 ppm  respectively  (Analytical Bio
Chemistry Laboratories, 1978, MRID GS0076-008, -009, -010, -Oil).

Residues in cucumbers  (fruit) planted at 88 days post  application in  Texas
(both studies) were <0.01 ppm (Analytical Bio Chemistry Laboratories  1978,  MRID
GS0076-001).

Residues in soybeans (as threshed beans) planted 239,  261, and 287 days
following last application in Mississippi, Georgia, and Texas (two studies)
were <0.01, <0.01, 0.02, and 0.25 ppm respectively.  Soil residues  (0-6"  depth)
at planting and harvest were 0.11, 0.14; 0.04, 0.32; 0.02, 0.02; 0.26, 0.28 ppm
respectively (Analytical Bio Chemistry laboratories, 1978, MRID GS0076-008,
-013, -014, -015).

Residues in soybeans (as dry vines) planted 239, 261,  287, and 300 days  after
last application in Mississippi, Georgia, Texas (two studies) and Florida were
0.03, 0.17, 0.15, 2.05, and <0.01 ppm respectively.  Soil samples  (0-6")  were
0.11, 0.14; 0.04, 0.32; 0.02, 0.02; 0.26, 0.28; not available, and 0.07 ppm
respectively (Analytical Bio Chemistry Laboratories, 1978, MRID GS0076-008,
-012, -013, -014, -015).
                                       48

-------
Oi the basis of the available data, the Agency believes  that a  six month  crop
rotational restriction is sufficient  for potato  tubers and  cucumbers  for  all
areas tested.  Similarly, the Agency  believes that  a  60  day rotational  crop
restriction would be sufficient  for turnips  and  peas.  Significant residue
levels do, however, occur in soybeans at 12  months.   As  insufficient  data are
available, and no petition  for a rotational  crop tolerance  has  been proposed,
the Agency will impose a rotational crop restriction  upon all crops other than
potatoes, cuicumbers, turnips and peas.  These latter crops, at the option of
the registrant, may be identified upon labeling  as  being crops  which  may  be
rotated following a six month interval.
                                       49

-------
                               VI.  TOXICOLOGY
     A.  Toxicology Profile - Manufacturing-Use Sulprofos
     B.  Toxicology Profile - End Use Product(s)
     C.  Human and Domestic Animal Hazard Assessment

Toxicology - Manufacturing-Use Sulprofos

Toxicology Profile

Data meeting nearly all Agency requirements with regard  to  a  toxicological
characterization of manufacturing-use sulprofos have been submitted  and
evaluated.  For the purpose of this Standard, manufacturing-use  and  the
technical chemical shall be viewed as synonymous terminology.  The results and
conclusions pertinent to these investigations are noted  below in order of their
appearance as Guideline requirements.

2.  Acute Oral

The acute oral toxicities of sulprofos technical, sulprofos analytical
standard, the sulfone, sulfoxide, and the oxygen analogues  of sulprofos  and
sulprofos sulfoxide have been adequately delineated through laboratory
evaluations utilizing male and female test rats. These oral toxicities have
been defined as follows:
    a.  Technical Sulprofos  (Lamb and Matzkanin,  1975, MRID GS0076-125)
                             (Lamb and Matzkanin,  1975, MRID GS0076-126)
                             (Lamb and Matzkanin,  1978, MRID GS0076-130)
                             (Lamb and Matzkanin,  1978, MRID GS0076-131)

        LD   male 262 (211-326)
        LDj?g female 275 (201-376)

    b.  Sulfone (Lamb and Matzkanin, 1978, MRID GS0076-132)

        LD™ male 283 (222-361) mgAg
        LD5Q female 404 (329-496 mgAg

    c.  Oxygen analogue of sulfone  (Lamb and Matzkanin,  1978,  MRID GS0076-133)

        LD Q male 74 (47-115) mgAg
        LD _ female 133 (114-155) mgAg
                                      50

-------
    d.   Sulfoxide (Lamb and Matzkanin, 1978, MRID GS0076-134)

        LD,-- male 263 mg/kg
        LD^ female 283 (243-330) mgAg

    e.   Sulprofos analytical standard  (Lamb and Matzkanin,  1978, MRID GS0076-
        135)
        LD   male 208 (172-251)
        LD^Q female 356  (306-416) mgAg

    f.  Ckygen analogue of Sulprofos  (Lamb and Matzkanin,  1978, MRID GS0076-136)

        LD   male 73  (53-98) mgAg
        LDj?Q female 206  (142-299) mgAg

    g.  Oxygen analogue of sulfoxide  (Lamb and Matzkanin,  1978, MRID GS0076-137)

        LJX- male 62  (47-80) mgAg
        LD^ female 84  (67-104) mgAg

From these data, the Agency may conclude  that sulprofos  technical  and  its
metabolites may, when ingested, present a moderate acute hazard to humans.   The
range of LD   values  fall within those parameters provided under Toxicity
Category II.

3.  Acute Dermal Toxicity

Data fulfilling all Agency requirments with  regard to testing  in relation to
the acute dermal toxicity of manufacturing-use  (technical) sulprofos have been
submitted and reviewed  (Lamb and Matzkanin,  1975, MRID GS076-122).  The results
of these studies are as  follows:

    a)  Rat dermal LD,-n  - male  -   >1,000 mgAg
                      DU     female  -  XL, 000  mgAg

    b)  Rabbit Dermal LD,-n -male   -  820 (599-1123)  mgAg
                         5U     female - 994  (492-2009) mgAg

The preceding acute dermal toxicity data  are adequate to permit an evaluation
of the dermal hazard presented by sulprofos  technical to mammalian species.
These data indicate that manufacturing-use sulprofos  may be considered
moderately toxic through dermal absorption.  The range of  LD5Q values  fall
within those parameters provided under Toxicity Category II.
                                       51

-------
Acute Inhalation Toxicity

Data fulfilling Agency testing requirements with regard  to the acute inhalation
toxicity of manufacturing-use sulprofos have been obtained and reviewed by the
Agency.  These test data were developed through the exposure of rats,  mice,
and hamsters at multiple exposure levels and durations.   The aggregate test
data indicate that, for all species tested, the acute  inhalation LC,-0  values
are all greater than 0.5 mg/L (Kimmerle, G. 1975, MRID GS0076-102).  The Agency
may, therefore, conclude that manufacturing-use sulprofos may be considered
moderately toxic by means of inhalation.  The LCrQ values place sulprofos
within Toxicity Category II.

Primary Eye Irritation

Data fulfilling Agency requirements regarding the primary eye irritation
potential of manufacturing-use sulprofos have been received and reviewed by the
Agency.  These data provide that upon placement of 100 microliters of  sulprofos
technical within the conjunctival sack of rabbits for  exposure periods of 5
minutes and 25 hours, no irritation was observable through the seven day
observation period  (Groning and Kimmerly 1975, MRID GS0076-092).   The  Agency
may, therefore, conclude that manufacturing-use sulprofos can be considered non-
irritating to the eyes.  The failure of sulprofos to produce observable eye
irritation places it within Toxicity Category IV for this criteria.

5.  Primary Dermal Irritation

All data requirements with respect to the characterization of manufacturing-use
sulprofos's potential for causing dermal irritation have been fulfilled.  The
Agency, upon review of these data has determined that  sulprofos induces no
erythema or edema when applied to either intact or abraded skin (Gronig and
Kimmerle 1975, MRID GS0076-092).  The failure of sulprofos to produce
observable skin irritation at 72 hours post administration places it within
Toxicity Category IV for this criteria.

6.  Darmal Sensitization

The Agency has received and reviewed a dermal sensitization study conducted
with manufacturing-use sulprofos.  From these data, the  Agency has determined
that the irritation produced by the challenge  injections was not substantially
higher for any reaction evaluation parameter  (erythema,  edema, diameter) than
for the sensitizing injections  (Lamb and Anderson  1976,  MRID GS0076-118).  The
Agency has, therefore, concluded that manufacturing-use  sulprofos is not a
sensitizing agent by dermal application.
                                       52

-------
7.  Acute Delayed Neurotoxicity

Data relative to the delayed neurotoxic  potential  of  manufacturing-use
sulprofos have been made available by  the  registrant.   These data provide  the
results of studies involving the dosing  of hens  at rates ranging  from
25 to 250 mgAg.  Surviving birds were observed  for 28  days prior to
sacrifice.  Although normal signs of organophosphate  poisoning  persisted  for
up to eleven days, clinical as well  as histological examination produced no
indication of delayed neurotoxicity  (Thyssen and Siegmund 1975, MRID
GS0076-181).  On the basis of these  data,  the Agency  has concluded  that
manufacturing-use sulprofos possesses  no inherent  potential for delayed
neurotoxicity.

8.  Subchronic Oral Toxicity

Agency review of submitted subchronic  oral toxicity data have provided that, in
the rat, dose levels of 30, 100, and 300 ppm resulted in depression of plasma
cholinesterase.  Erythrocyte.cholinesterase depression  occurred at  levels  of
100 ppm and above as did brain cholinesterase; the latter occurring only  in the
female at the 100 ppm level.  There  were no observable  effects  related to
hematology, blood chemistry, urine analysis and  macroscopic or  microscopic
pathology.  The no observed effect level (NOEL)  established as  a  result of
these data was 10 ppm  (Groning and Dieckman, 1975, GS0076-091).

A second subchronic oral toxicity study  involving  90-day administration of
sulprofos to dogs has been reviewed  by the Agency. Although this study has
been ruled supplemental due to the failure of the  study to provide  for a  full
six month test duration, no additonal  data shall be required due  to the
adequacy of the chronic studies which  shall be noted  later in  this  chapter.
The results of this study, are, however, of interest  to the Agency.  The data
provide that both male and female animals, dosed at the 200 ppm level, showed a
significant decrease in body weight  change; males  also  demonstrated
significantly lower feed consumption.  At 200 ppm, both sexes  showed signs of
intoxication, diarrhea and regurgitation with some rear leg involvement
occuring in the females.  There were additionally  shifts in blood chemistry,
histologic lesions and cholinesterase  depression at the 200 ppm level. At the
20 ppm level, plasma cholinesterase  depression was the  only dose  related
effect.  No observable effects were  apparent at  the 10  ppm level  (Lamb, 1975,
MRID GS0076-110).

9.  Subchronic Inhalation

Limited data are available to the Agency concerning the subchronic  inhalation
toxicity of manufacturing-use sulprofos.  The single  available  study must be
judged supplemental due to the duration  of the test,  21 days,  falling short of
the prescribed 90-day exposure period.   The Agency does not, however, consider
the lace of these data to be critical.  Due to both the pattern of  chemical
                                       53

-------
use, and the outcome of the available chronic studies,  the  Agency believes the
potential effects resulting from anticipated subchronic inhalation exposure to
warrant little concern.  Although only supplemental,  the results from available
testing indicate that up to concentration levels of  14  mg/m ,  no physical
appearance, growth rate, or behavioral changes occur.   It may  be additonally
noted that an evaluation of the clinical chemistry,  hematology,  urinalyses,
macroscopic pathology and histopathology indicated no variation  from normal
(Kimmerle 1975, MRID GS0076-103).

10.  Oncogenicity

The Agency has received and reviewed a two-year feeding study  on Fisher 344
rats.  Dietary dosages of 0, 6, 60 and 250 ppm sulprofos were  administered in
accordance with accepted test protocol.  Body weights,  organ weights and food
consumption were not affected at any level, except for  high dose female groups
which consumed relatively more food, but maintained  weight. Blood chemistry,
hematology and urinalysis were normal for all groups  with the  exception of
cholinesterase (ChE).  Plasma and red blood cell  (RBC)  ChE  were  depressed at 60
and 250 ppm for males and females, with Brain ChE inhibited only at 250 ppm for
both sexes.  At 6 ppm no significant inhibition was  noted.   Gross
histopathology showed no compound related effects, or tumor formation.   The ChE
no effect level (NOEL) for the rat has been established at  6 ppm (Lamb, 1978,
MRID GS0076-114).

In a similar study, Swiss mice were fed at levels of  2.5, 25,  200 and 400 ppm
for 22 months.  The only significant findings of this study were related to ChE
inhibition.  Plasma and RBC ChE were significantly inhibited at  25 ppm and
above, with brain ChE inhibition becoming apparent at 400 ppm.   All other
parameters evaluated by the study showed no compound  related effect.  Gross and
histopathology showed no somatic or oncogenic effect.   The  ChE NOEL,established
for the mouse is 2.5 ppm (Lamb, 1978, GS0076-115).

An additional two year feeding study involving the dosing of beagle dogs
at levels of 10, 100 and 150 ppm has been evaluated  by  the  Agency.  In this
study, the only affected parameter was ChE.  At 100  and 150 ppm  plasma, RBC and
brain ChE were inhibited.  The established ChE NOEL  for the dog  is 10 ppm with
no somatic effects at 150 ppm (Lamb, 1978, MRID GS0076-117)

Given the results of the available data, the Agency  has concluded that
sulprofos poses no significant oncogenic risk.  In addition, conversion of the
ChE NOEL into mgAg/day for each of the three species noted above, provides an
adequate basis for acceptable daily intake calculation  (ADI).  The lowest
value, that calculated for the dog  (0.25 mg/kg/day),  shall  be  used by the
Agency for all ADI calculations.
                                       54

-------
11.  Teratogenicity

Sulprofos has been evaluated  for  teratogenic  potential  in a single  study
involving the dosing of rabbits from  the  time of  implantation  through  the
period of major organogenesis (days 6 through 18).   The rabbits were orally
dosed at rates of 3, 10 and 30 mgAg/day.   Fetuses derived by  ceasarean  section
showed neither skeletal nor visceral  abnormalities  (Machemer 1975,  MRID
GS0076-141).

While the Agency believes  that the preceding  teratogenicity study,  coupled
with the three generation  reproduction study  to be detailed below,  are a
reasonable indication of sulprofos1 nonteratatogenicity,  the Agency shall
require a confirmatory test as proposed under Guideline section 163.83-3.   For
additional information with regard to the rational  underpinning this
requirement, refer to Chapter III.

12.  Reproduction

The potential reproductive effects of sulprofos have been evaluated in a three
generation study.  Male and female rats were  subjected  to exposure  levels of
30, 60, and 120 ppm  under  conditions  of established  protocol.  Following
evaluation of two litters  per generation  through  three  generations, it was
found that reproductive performance and reproductive indexes were not  affected
at any level  (Hazelton Laboratories America,  Inc. 1978, MRID GS0076-095).   The
reproductive effect  1SDEL established  as a result  of these data is 120  ppm.   On
the basis of these data, the  Agency believes  that sulprofos posesses no
potential for mammalian reproductive  impairment.

13.  Mutagenicity

The mutagenic potential of sulprofos  has  been assessed  in a single  dominant
lethal assay.  Male  mice were dosed at 200 mg/kg, and mated weekly  for eight
weeks to virgin females.   Implantation losses and fetal survival  were  not
affected throughout  the observation period (Machemer, 1975, MRID  GS0076-140)

Although the available dominant lethal assay  does serve as partial  evidence
that sulprofos is nonmutagenic, it can not be ruled  as  conclusive.  The  Agency
requires four studies relating to potential heritable effects. These  studies
involve a mamalian in-vitro   point mutation test, a sensitive  sub-mammalian
point mutation test, a primary DMA damage test and  a mammalian in-vitro
cytogenetics test.   The available dominant lethal assay will be considered  as
acceptable in fulfilling the  requirment for a mammalian in-vitro
cytogenetics test.   For additional information related  to additional
mutagenicity test requirments, see Chapter III.
                                       55

-------
14.  General Metabolism

Consistent with the findings of those studies discussed within  the
Environmental Fate chapter of this standard, a general metabolism study
conducted with female white rats has demonstrated that sulprofos  metabolizes
rapidly and is excreted principally in the urine  (approximately 92 percent  in
24 hr.).  The metabolites present in the urine were water-soluble compounds
which underwent conversion to free phenolic derivatives through hydrolysis  with
glucoronidase-aryl sulfatase or acid.  Tissue analysis provided that the
remaining sulprofos existed as parent compond, five phosphorus  containing
oxidative metabolites and three substituted phenols  (Bull  and Ivie,  1975, MRID
GS0076-032).

B.  Toxicology Profile ^ End Use Sulprofos

Toxicology Profile

The data provided below relate singularly to Bolstar® 6, the only registered
product containing sulprofos as its sole active ingredient.  Given the
appearance of inert related acute effects, principally in  relation to eye
irritation, the Agency does not believe it sound  to attempt to  expand the
inferences provided by these data beyond the present 64% formulation.  The
available data are, however, adequate to characterize the  acute toxicity of
Bolstar® 6.

Data have been reviewed which provide that Bolstar® 6, like manufacturing-use
sulprofos, is a Category II oral toxicant with rat acute oral LD,-Qs  in  the
range of 90 to 150 mgAg (Lamb and Matzkanin, 1975, MRID GS0076-I27).
Similarly, Bolstar® 6 falls within toxicity category II in relation  to  its
acute dermal effects (Lamb and Matzkanin, 1975, MRID GS0076-123).  The
established rabbit acute dermal ID™ values fall  within the range of 750 to
850 mgAg.  The acute inhalation toxicity of Bolstar® 6 is somewhat  reduced
from that of the technical with the calculated LC™ values all  being greater
than 2.0 mg/L for the rat (Lamb and Matzkanin, 1975, MRID  GS0076-124).   Bolstar®
6, therefore, falls within toxicity category III  with regard to inhalation.
While Bolstar® has been demonstrated not to pose  any risk  with  regard to either
skin irritation (Lamb and Matzkanin, 1975, MRID GS0076-128), it has  been shown
to be irritating to the eyes (Lamb and Matzkanin, 1975, MRID GS0076-129).
Product labeling, therefore, shall bear those statements consistent  with a
category II eye irritant.

In addition to those acute data customarily required for end-use  products,  the
registrant has submitted an unsolicited subacute  dermal study conducted on
rabbits  (Lamb and Matzkanin, 1975, MRID GS0076-121).  Male and  female animals
were exposed to 100 mg applications of Bolstar®  6 for daily eight hour  periods,
five days a week through three weeks.  All applications were made to the shaved
backs of the animals.  There were no observable changes in blood  chemistry,
                                       56

-------
hematology, urinalysis, organ weights and gross or microscopic  pathologies.   As
would be anticipated, erythrocyte,  plasma and  brain  cholinesterase were
significantly depressed.  Only  slight erythema and edema were noted following
the second week.  Although a less severe test  than that afforded  by a subacute
trial involving the  technical product,  the  absence of  chronic effects,  coupled
with that information provided  by other chronic studies, permits  the Agency to
waive the requirement for a 21-day  subacute dermal toxicity  test  conducted  with
the manufacturing-use product.

C.  Human and Domestic Animal Hazard Assessment

The sulprofos exposure profile  (refer to Chapter  V)  provides that maximum
exposure will occur  to those involved  in direct mixing, loading,  and
application.  The principal routes  of exposure may be  anticipated to be dermal
and inhalation; the  latter coming  from  applicator exposure to  spray mist.
As noted above, the  acute toxicity  of Bolstar® 6  falls within  Categories II and
III depending upon route of exposure.   These  toxicity  ranges are  consistent
with the majority of those organophosphate  compounds commonly  applied to field
crops.  The Agency believes that the acute  hazards,  as mitigated  by those
precautionary measures prescribed by product  labeling, would be within
acceptable limits.   Although the Agency does  not  possess  the full complement of
chronic toxicity data, those data available for Agency review  do  not indicate
any potential  for oncogenic, teratogenic,  neurotoxic or reproductive effects.
The Agency, therefore, believes that Bolstar®, when  used  in accord with label
directions, presents no chronic hazard.

The full range  of sulprofos  toxicity data  has been reviewed against the
requirements of the  draft Subpart K Registration  Guidelines (Exposure Data
Requirements:   Reentry Protection). Sulprofos neither meets nor  exceeds any of
the requirement criteria  established under section 163.130-3(a)(1).  The Agency
will not,  therefore, require data in support  of reentry intervals.
                                       57

-------
                          VII.  Residue Chemistry


     A.  Residue Chemistry Profile
     B.  Analytical Methods


Residue Chemistry Profile


Both the residues of parent sulprofos as well as its major metabolites  are  of
concern.  Enzyme inhibition studies have been conducted which demonstrate that
the sulfoxide and sulfone derivatives of sulprofos, as well  as  its oxygen
analog and its sulfoxide and sulfone derivatives are cholinesterase  inhibiting
compounds.  These studies additionally indicate that inhibition activity
increases with the degree of oxidation (Groning 1975, MRID GS0076-080).

The fate of sulprofos, when applied to cotton, has.been characterised through
radiotracer studies using uniformly ring labeled   C sulprofos  or    P
labeled sulprofos.  It has been demonstrated that approximately 73 percent  of
the applied sulprofos may be found upon the surface of the treated leaves.
Less than 1.0 percent of the applied activity is detectable  on  all other plant
parts, thus demonstrating that there is essentially no translocation of
sulprofos residues (Bull et al., 1975, MRID GS0076-034).

Radiolabeled field studies have demonstrated that residues are  principally  lost
through volatilization.  These studies additionally demonstrate that sulprofos
undergoes oxidation and/or hydrolysis to the various phenolic metabolites
which are subsequently conjugated to natural plant constituents.  In
field studies, approximately 15-20 percent of the activity recovered at 32  days
was cholinesterase inhibiting compounds.  No parent compound was detectable
following eight days.  At 32 days the sulfoxide was the principal component of
the toxic residues (66percent%), with the sulfone and the oxygen analogue of
the sulfone comprising the remaining 29 and 5 percent respectively  (Bull
et al., 1975, MRID GS0076-034).

Field residue studies reflecting 5-15 applications of 1 and  1.5 times the
maximum labeled rate have been undertaken with cotton plants at various stages
of plant development.  The highest value reported was 0.36 ppm  which resulted
after 13 applications at the high rate and a 30 day preharvest  interval. The
data indicate little, if any, correlation between residue levels and preharvest
intervals.  Data reflecting both aerial applications and treatment of furrow
irrigated cotton similarly indicate that residues would not  be  expected to
exceed 0.5 ppm (Blocker, M., 1975, MRID GS0076-027, -028),  (Huddleston,  E.E.,
1975, MRID GS0076-096), (Mobay Chemical Corporation, 1975, MRID GS0076-147,
-148), (Nash, R.F. 1975, MRID GS0076-162), (Rowehl, E., 1975, MRID GS0076-170,
-171), (Scott, A., 1975, MRID GS0076-176).
                                      58

-------
Storage stability studies determining  the  stability of sulprofos residues in or
on cottonseed, gin trash  (Atwell,  S.H.,  1978,  MRID GS0076-021),  bovine tissues
and milk (Atwell, S.H., 1975, MRID GS0076-020)  during  frozen storage have been
submitted to and evaluated by the  Agency.   In  these studies, cottonseed,  gin
trash, bovine liver, muscle and  fat  tissues, and  milk  were fortified with
labeled sulprofos and  stored at  -10°C  for  five months.  With the exception
of the liver sample, 74-96 percent of  the  activity was recovered as sulprfos
per se and essentially all the remaining activity in these samples was present
as the sulfoxide metabolite.  Only 3 percent   of  the activity detected in the
liver was parent compound.  The  sulfoxide  and  sulf one  metabolites accounted for
8 percent and 13 percent  respectively.   Although  the studies show that
oxidation of the parent compound does  occur in the liver, they also show that
essentially all of the fortified activity  would be detected as sulprofos by the
enforcement method.

A cottonseed processing fraction study has also been submitted to and
reviewed by the Agency.   In this study,  cottonseeds were treated at
1.5 times the maximum  rate and were harvested  one day following treatment for
processing into hulls, meal, crude and refined oils and soapstock fractions.
The raw cottonseed bore residue  of 1.7 ppm and the hulls, meal, crude oil,
refined oil and soapstock contained  levels of  3.28, 0.22, 3.22, 2.29 and 1.25
respectively.  The data indicate that  residues do concentrate in the hulls
(approximately 1.9X) and  refined oil (approximately 1.3X).  The Agency
has, therefore, determined that  the 1.0 ppm food  additive tolerance for
residues in cottonseed hulls and oil is appropriate.  No food additive
tolerances are needed  for the  remaining fractions (cottonseed meal and
soapstock) which the Agency would  expect to contain levels of approximately
0.07 and 0.35 ppm respectively (Chemagro Agricultural Division, 1975, MRID
GS0076-036).

In addition to those  investigations involving  cotton,  radiotracer studies
using uniformly ring  labeled    C sulprofos have been conducted to determine
the fate of the parent compound  and  its metabolites in rats, cattle, swine and
chickens.  In tests involving  lactating dairy cattle,  it has been demonstrated
that sulprofos is rapidly oxidized and/or  conjugated and excreted via the urine
or feces almost quantitatively.  The low levels of activity found in the
tissues and milk were  principally  (about 80%)  present as phenolic metabolites
lyie, et al., 1975, MRID  GS0076-099).   In  association with the
  C labeled studies,  the  Agency has reviewed a cold study in which cows were
fed a total of 5, 25 and  250 ppm sulprofos, the sulfoxide metabolite and the
sulfone metabolite  in a ratio  of 1:2.5:1.5 respectively  (the 5 ppm feeding
level representing approximately a 40X and a 15X exaggeration factor for
dairy and beef cattle  diets respectively).  By methods sensitive to 0.01 ppm,
                                       59

-------
residue levels in the liver samples were reported as  <0.01,  0.01,  and 0.03 for
three cows fed at the 5 ppm level.  With the exception of one fat sample with a.
level of 0.01 ppm, all other tissue sample residues were  reported  as <0.001 to
0.003 (Chemagro Agricultural Division 1975, MRID GS0076-038).  Trace residues
of sulprofos or its cholinesterase inhibiting metabolites may be  found in
bovine tissues.  The Agency believes, however,  that these data indicate that
there is no significant tendency for residues to store in the tissue.


Metabolism of sulprofos by swine has been found to be similar to  that of the
cow.  Essentially all activity is eliminated within 24 hours.  Again,
elimination is principally via the urine (93 percent  and  3 percent via the
urine and feces respectively).  At two and four hours post treatment, only
phenolic metabolites are detectable (Pither and Gronberg, 1976, MRID GS0076
-168).

In a study in which labeled sulprofos was administered orally to  laying hens at
1 mg/kg (approximately equal to 18 ppm in  the  diet),  excretion was essentially
complete after 24 hours with an average total of 92.3 percent excreted.  Except
for 24 hour kidney samples, only the 6 hour tissue samples contained detectable
residues, and of these only the liver contained sufficient activity (0.1 ppm)
for analysis.  No detectable activity was found in any of the egg  samples
collected (Flint, D.R. 1975, MRID GS0076-083).  In a  series  of poultry studies,
sulprofos residue levels were determined for meat organs  and eggs (Chemagro
Agricultural Divsion 1978, MRID GS0076-040, -041, -042, -043) (Mobay Chemical
Corporation 1978, MRID GS0076-155).  Laying hens were fed a  ration containing
sulprofos, sulprofos sulfoxide and sulprofos sulfone  at 5, 15, 50 and 150 ppm
of their diet for 28 days (the 50 ppm level reflecting an exaggeration factor
of approximately 2,000).  No cholinesterase inhibiting residues were detected
in any of the poultry tissues or eggs of birds  treated at the 50  ppm level or
less by a method sensitive to 0.05 ppm.  At the 150 ppm dose level, the only
detectable residues were 0.22 ppm in fat and 0.05 ppm in  skin.

Based upon its assessment of all those data relating  to residues  of sulprofos
and its metabolites, the Agency finds that those tolerances  previously
established (43 FR 32132  July 25, 1978) are adequate. These tolerances,
however, may be subject to reassessment with the receipt  by  the Agency of
additional pertinent information.

B.  Analytical Methods

The Agency requires the submission of, or reference to, validated analytical
methods suitable for obtaining data on the nature and amount of pesticide
residues resulting from proposed uses.  Cne method must be suitable for
tolerance enforcement.  The regulatory method for determination of a pesticide
in raw agricultural commodities must be capable of measuring the  total toxic
residue derived from the pesticide.
                                       60

-------
The analytical method developed  for the acquisition of sulprofos related
residue data for cotton  seed  and cottonseed fractions has been reviewed and has
undergone a successful Agency method tryout.   The procedure involves an initial
extraction of the cottonseed  (or hulls or meal)  with acetone and chloroform in
the presence of Super-Gel®.   Following the stripping off of the solvents,  the
residues are partitioned between hexane and acetonitrile.  The concentrated
acetonitrile layer  is chromatographed on a Florisil column.  The eluate is then
partitioned against benzene,  oxidized with meta'-chloroperbenzoic acid to form
the oxygen analog of the sulfone metabolite of sulprofos which is measured
using a gas-liquid  chromatograph (GLC) equiped with a thermionic detector
(Sandi, F.E.,1975,  MRID  GFS0076-172) (Sandi and  Gronberg, 1975, MRID GS0076-
175).  The procedure for the  analysis of cottonseed oil is essentially
identical with the  exception  that the initial step is the partitioning between
hexane and acetonitrile.

Modifications to the above procedure to permit the determination of sulprofos
residues in animal  tissues, milk and eggs have been developed.  These
modifications involve alterations in the initial extraction procedures - using
acetonitrile and or hexane instead of acetone and chloroform (Sandie and
Gronberg,  1975, MRID GS0076-174).

In addition to the  above-noted analytical methods, an interference study has
been submitted and  reviewed by the Agency.  In this study, cottonseed samples
were fortified with various pesticides at the tolerance level established for
sulprofos.  Compounds with zero  tolerances were  spiked at 0.1 ppm.  With the
exception  of Guthion and its  oxygen analogue, interference from these compounds
was negligible.  The 0.5 ppm  Guthion and Guthion oxygen analog spikes produced
GLC peaks  with the  same  retention time as the sulprofos (actually, the oxygen
analog of  the sulfone) and equivalent to 0.07 and 0.11 ppm respectively.  These
levels are equal to only 14 and  22 percent of the established tolerance and
would not  interfere with the  determination of sulprofos only if the sulprofos
was present at levels below its  tolerance (Close, C.L., 1975, MRID GS0076-
074).

A confirmatory procedure, eliminating any interference from Guthion residues,
has been developed. This procedure involves utilizing a GLC column with a
different  polarity  (Close, C.L., 1975, MRID GS0076-076).

In view of those facts presented by the preceeding discussion of analytical
methodology, the Agency  has determined that the analytical methods are suitable
for enforcement of  all established tolerances.
                                       61

-------
                           VIII.  ECOLOGICAL EFFECTS
     A.  Avian Toxicity
     B.  Mammalian Toxicity
     C.  Aquatic Organism Toxicity
     D.  Nontarget Insect Toxicity


Sulprofos, as noted earlier within the Use Profile section of  Chapter V.,  is a
field use insecticide/acaricide applied by either ground or aerial equipment.
As a function of both the site and method of application, it may be  readily
anticipated that some potential for exposure to nontarget terrestrial and
aquatic organisms does exist.

A.  Avian Toxicity
Sulprofos has been determined to be highly toxic to upland game  birds.   The
LD   , as determined for bobwhite quail, has been calculated to be 47 mg/kg•
These same data, subjected to Finney Probit Analysis, have provided  an LD1Q
of 24 mg/kg (Fink R., 1979, MRID GS0076-081).  In a similar study conducted on
mallard ducks, Agency analysis of the data has provided LD   values  of 72.1
(43.9-118.4) and 112.2 (87.9-143.2) mg/kg for males and females  respectively
(Lamb and Jones, 1975, MRID GS0076-119).  This latter study, although
determined to be only supplemental due to the appearance of several  anomalies
within the experimental procedure and the data reporting, is being considered
as sufficient for an interim determination.

Eight day subacute feeding studies on bobwhite quail and mallard ducks
have similarly provided that sulprofos is highly toxic to avian  species.   The
dietary IC™ f°r bobwhite quail, as provided by the data, is 99  ppm.  These
same data, when subjected to probit anlaysis, have provided an LC,Q  of
63 ppm.  The acute dietary toxicity of sulprofos to waterfowl  appears somewhat
less.  The eight day dietary LC,-Q for mallard ducks has been calculated to be
on the order of 983 ppm (Lamb and Jones 1975, MRID GS0076-120).

Although acutely toxic, sulprofos does not appear to pose a significant
reproductive risk in relation to upland game birds.  Sulprofos technical has
been found to have no statisticallly significant effect on reproduction when
fed to bobwhite quail at dietary levels up to 19 ppm actual  (20  ppm  nominal)
(Fink, R., 1979, MRID GS0076-082). The one-generation reproductive  impairment
study available for waterfowl has indicated that the no effect level is
significantly less than that noted for upland game birds  (Wildlife
International, Ltd., 1978 MRID GS0076-185).  The reproductive  impairment NOEL
                                       62

-------
for the mallard duck is  <3 ppm.  This  latter  study,  however,  has  been
designated as supplemental data, not fully fulfilling  Agency requirements.   The
Agency shall not, however, identify this  study as  a  data gap within the current
standard.  These data may, however, be requested  should expanded  use patterns
involve sites of application presenting an increased exposure potential to
waterfowl species.

The preceding avian data do indicate that there may  be an acute or subacute
hazard to certain avian  species. The Agency,  however,  in the absence of field
study data, does not have sufficient information  with  which to assess potential
adverse effects which might ensue  actual  use.   Dietary levels resulting from
differing treatment methods and  regimes must  be identified before the Agency
may fully delineate sulprofos1 potential  effects  in  relation to avian species.
See Chapter III for identification of  additional  study requirements.

B.  Mammalian Toxicity

In relation to mammals,  the Agency has utilized that data submitted in response
to human health effectd  data requirements. For a discussion of these data,
please refer to Chapter  VI.

C. Aquatic Organism Toxicity

With respect to aquatic  organisms, sulprofos  appears reasonably toxic to both
invertebrate and vertebrate species.   In  two  seperate  studies, Daphnia
magna  exhibited pronounced sensitivity with  48 hour EC™ values  of 0.75
(0.52 - 1.09) and 0.83  (0.69 -  0.99) ppm  (Morrissey, A.E., 1979,  MRID GS0076-
160 and Nelson, D. 1979, MRID GS0076-164). Only  data  classified  as
supplemental are available for vertebrate species.  These data do, however,
point to sulprofos being acutely toxic to fish with  96 hour I£cn  values of
1.0  (0.7 - 1.5), 2.9  (1.9 - 4.4),  and  29.7 (25.4  - 34.6) ppm for  the bluegill
sunfish, channel catfish and rainbow trout respectively (Lamb and Roney, ?,
MRID GS0076-138).  The supplemental, rather than  valid, classification applied
to these data stems,  in  large part, from  the  inability of, the researchers to
render sufficient sulprofos soluble in water.   Although these data tend to
indicate that sulprofos  may present an acute  hazard  to both vertebrate and
invertebrate aquatic species, there remains some  question as to the potential
mobility of sulprofos and/or its degradation  products  from sites  of application
into aquatic environments.  As noted within Chapters III and V, the Agency has
identified adsorption/desorption data  as  a data gap.  Upon receipt of
acceptable adsorption/desorption data, the Agency will be in a position to
calculate an estimated environmental concentration (EEC).  Should the EEC
demonstrate a theoretical potential for the movement of harmful concentrations
of either sulprofos and/or its degradation products, the Agency will require
both embryolarvae and aquatic field test  studies.
                                       63

-------
D.  Kbntarget Insect Toxicity

Very limited data are available with respect to sulprofos1 acute  toxicity to
beneficial insects.  Those data that are available, however, provide  that
sulprofos, like roost organophosphate pesticides, is toxic  to the  honey bee
(Johansen et al., 1975, MRID GS0076-101). Although these data are limited,
they appear adequate in relaton to current hazard labeling needs.  Aflditional
study requirements may, however, be necessitated by the addition  of critical
sites of application to the labeling and upon the promulgation  of Subpart L of
the Guidelines.
                                      64

-------
                            IX.  CASE BIBLIOGRAPHY

                       Guide to Use of This Bibliography


1.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.  The bibliography  is divided into two sections:  (1)  citations
in numerical order that contributed  information  useful to the review of the
chemical and are considered to be part of the data  base supporting
registrations under the standard,  (2)  citations in numerical order that have
been examined and judged  *-o be inappropriate  for use  in developing the
standard.

2.  Units of 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 from 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 left
    of the citation proper, a  nine-digit numeric identifier.  This number is
    unique to the citations and should be used at any time specific reference
    is required.  This number  is called  the  "Master Record Identifier" or
    "MRID".  It is not related to the six-digit  "Accession Number", which has
    been used to identify volumes of submitted data;  see paragraph 4(d)(4)
    below for a further explanation.   In a few cases, entries added to the
    bibliography late in  the review may  be preceded by a nine-character
    temporary identifier. 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
                                       65

-------
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 National Standards
Institute (ANSI), expanded to provide for certain special  needs.   Some
explanatory notes of specific elements follow:

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

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

c.   Title.  This is the third element in the citation. In some  cases it
     has been necessary for Agency bibliographers to create or enhance a
     document 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  word "received1
          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, immediately following
          the word  'under', 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.
                                   66

-------
(3)   Submitter.   The third element is the submitter, following the
     phrase "submitted by'.  When authorship is defaulted to the
     submitter,  this element is omitted.

(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 'CDL1, standing for
     "Company Data Library".  This accession number 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 would be 123456-A; the
     second, 123456-B; the 26th, 123456-Z; and the 27th,123456-AA.
                              67

-------
                         OFFICE OF PESTICIDE PROGRAMS
                REGISTRATION STANDARD ALPHABETICAL BIBLIOGRAPHY
          Citations Considered to be Part of the Data Base Supporting
                      Registrations Under the Standard
CASE GS0076

MRID

GS0076-001
GS0076-002
GS0076-003
GS0076-004
GS0076-005
GS0076-006
GS0076-007
Sulprofos

CITATION

Analytical Bio Chemistry Laboratories (1978) Recovery of
   Bolstar® from Cucumbers: Report No. 54436.  (Unpublished
   study received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

Analytical Bio Chemistry Laboratories (1978) Recovery of
   Bolstar® in Potatoes: Report No. 54438.   (Unpublished
   study received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

Analytical Bio Chemistry Laboratories (1978) Recovery of
   Bolstar® from Soybeans: Report No. 54445.  (Unpublished
   study received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

Analytical Bio Chemistry Laboratories (1978) Rotational Crop
   Residue Study: RGV-6502-76H: Report No. 54478.  (Unpublished
   study received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

Analytical Bio Chemistry Laboratories (1978) Rotational Crop
   Residue Study: 761-6504-76H: Report No. 54479.  (Unpublished
   study received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

Analytical Bio Chemistry Laboratories (1978) Rotational Crop
   Residue Study: RGV-6501A-76H: Report No. 54483.  (Unpublished
   study received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

Analytical Bio Chemistry Laboratories (1978) Rotational Crop
   Residue Study: 961-6513-76H: Report No.. 54484.  (Unpublished
   study received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

-------
GSQ076-008    Analytical Bio Chemistry Laboratories  (1978) Rotational Crop
                 Residue Study: RGV-6501-76H: Report No. 54485.   (Unpublished
                 study received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-009    Analytical Bio Chemistry Laboratories  (1978) Rotational Crop
                 Residue Study: VBL-6500-76H: Report No. 63005.   (Unpublished
                 study received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-010    Analytical Bio Chemistry Laboratories  (1978) Rotational Crop
                 Residue Study: RGV-6502-76H: Report No. 63006.   (Unpublished
                 study received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-011    Analytical Bio Chemistry Laboratories  (1978) Rotational Crop
                 Residue Study: 961-6506-76H: Report No. 63007.   (Unpublished
                 study received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-012    Analytical Bio Chemistry Laboratories  (1978) Rotational Crop
                 Residue Study: VBL-6507-76H: Report No. 63008.   (Unpublished
                 study received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-013    Analytical Bio Chemistry Laboratories  (1978) Rotational Crop
                 Residue Study: RGV-6508-76H: Report No. 63009.   (Unpublished
                 study received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-014    Analytical Bio Chemistry Laboratories  (1978) Rotational Crop
                 Residue Study: RGV-6509-76H: Report No. 63010.   (Unpublished
                 study received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-015    Analytical Bio Chemistry Laboratories  (1978) Rotational Crop
                 Residue Study: 761-6511-76H: Report No. 63011.   (Unpublished
                 study received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-016    Analytical Bio Chemistry Laboratories  (1978) Soil  Persistence
                 Study: Report No. 54491.   (Unpublished  study received Mar
                 13,  1978 under 8F2063; submitted by Mobay Chemical Co.,  Kansas
                 City, MO; CDL:096915)

-------
GS0076-017    Analytical Bio Chemistry Laboratories (1978) Soil Persistence
                 Study: Report No. 54492.  (Unpublished study received Mar
                 13, 1978 under 8F2063; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:096915)

GS0076-018    Analytical Bio Chemistry Laboratories (1978) Soil Persistence
                 Study: Report No. 54493.  (Unpublished study received Mar
                 13, 1978 under 8F2063; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:096915)

GS0076-019    Analytical Bio Chemistry Laboratories (1978) Soil Persistence
                 Study: Report No. 54494.  (Unpublished study received Mar
                 13, 1978 under 8F2063; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:096915)

GS0076-020    Atwell, S.H. (1975) The Stability of Bay NTN 9306 in Bovine
                 Tissues and Milk during Frozen Storage: Report No. 45375.
                 (Unpublished study received Nov 1, 1975 under 6G1705;
                 submitted by Mobay Chemical Co., Kansas City, MO; CDL:095559)

GS0076-021    Atwell, S.H. (1975) The Stability of Bay NTN 9306 in Cottonseed
                 and Gin Trash During Frozen Storage: Report No. 45383.
                 (Unpublished study received Nov 21, 1975 under
                 3125-EUP-132; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:094773)

GS0066-022    Atwell, S.H. (1978) A Gas Chromatographic Method for the Deter-
                 mination of Bolstar® Residues in Poultry Tissues and Eggs:
                 Report No. 53094.  (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:096915)

GS0076-023    Atwell, S.H. (1978) The Stability of Bay NTN 9306 in Cottonseed
                 and Gin Trash During Frozen Storage: Report No. 49076.
                 (Unpublished study received Mar 13, 1978 under
                 8F2063; submitted by Mobay Chemical Co., Kansas City,
                 Mo; CDL:096915)

GS0076-024    Atwell, S.H.; Gronberg, R.R. (1975) Leaching Characteristics of
                 Bay NTN 9306 on Aged Soil: Report No. 45286.  (Unpublished
                 study received Nov 1, 1975 under 6G1705; submitted by
                 Mobay Chemical Co., Kansas City, MO; CDL:095559)

-------
GS0076-025    Atwell, S.H.; Gronberg, R.R.  (1975) Leaching of Bay NTN 9306  in
                 Soil: Report No.  44817.   (Unpublished  study received Nov
                 1, 1975 under 6G1705; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:095559)

GS0076-026    Atwell, S.H.; Gronberg, R.R.  (1975) Photodecomposition of Bay'NTN
                 9306-ring-UL-  C: Report No.  44844.   (Unpublished
                 study received Nov  1, 1975 under 6G1705; submitted by
                 Mobay Chemical Co., Kansas City, MO; CDL:095559)

GS0076-027    Blocker, M.  (1975)  [Cotton Residue Report: Report No. 45402.]
                  (Unpublished study  received Nov 21,  1975 under 6G1705;
                 submitted by Mobay  Chemical Co., Kansas City,  MO; CDL:094773)

GS0076-028    Blocker, M.  (1975)  [Cotton Residue Report: Report No. 45407.]
                  (Unpublished study  received Nov 21,  1975 under 6G1705:
                 submitted by Mobay  Chemical  Co., Kansas City, MO; CDL:094773)

GS0076-032    Bull, D.L.;  Ivie, G.W.  (1975) The Metabolism of Bay NTN 9306  by
                 White Rats: Report  No. 45357.  (Unpublished study received
                 Nov  1, 1975 under 6G1705; prepared by  Cotton Insects
                 Research  Laboratory, College  Station,  TX; submitted by Mobay
                 Chemical  Co., Kansas City, MO; CDL:095559)

GS0076-034    Bull, D.L.;  Whitten, C.J.;  Ivie, G.W.  (1975) The  Fate of Bay  NTN
                 9306 in Cotton Plants, Water, and Soil: Report No. 45359.
                  (Unpublished study  received Nov 1, 1975 under
                 3125-EUP-132 prepared by  Cotton Insects Research Laboratory,
                 College Station,  TX; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:094773)

GS0076-036    Chemagro Agricultural  Division  (1975) Bay NTN  9306 From
                 Cottonseed: Report  No. 45384. (Unpublished  study received  Nov
                 21,  1975  under 6G1705; submitted by  Mobay Chemical Co.,
                 Kansas City, MO;  CDL:094773)

GS0076-037    Chemagro Agricultural  Division  (1975) Mobay Chemical Corporation
                 Residue Experiment-Cattle Tissues and  Milk: Report No.  45373.
                  (Unpublished study  received Nov 21,  1975 under 6G1705;
                 submitted by Mobay  Chemical Co., Kansas City,  MO; CDL:094773)

GS0076-038    Chemagro Agricultural  Division  (1975) Recovery of Bay  NTN 9306
                 From Cattle Tissues and Milk: Report 45355.   (Unpublished
                 study received Nov  21,  1975 under  6G1705;  submitted  by Mobay
                 Chemical  Co., Kansas City, MO; CDL:094773)

-------
GS0076-039    Chemgro Agricultural Division (1975) Recovery of Bay NTN 9307
                 From Cottonseed-Confirmatory GLC Method:  Report No. 45390.
                 (Unpublished studyreceived Nov 21, 1975 under 6G1705;
                 submitted by Mobay Chemical Co., Kansas City, MO; CDL:094773)

GS0076-040    Chemagro Agricultural Division (1978) Poultry Tissues Residue
                 Experiment: Report No. 53095. ( Unpublished study received
                 Mar 13, 1978 under 8F2063; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:096915)

GS0076-041    Chemagro Agricultural Division (1978) Poultry Eggs Residue
                 Experiment: Report No. 53096.  Unpublished study received
                 Mar 13, 1978 under 8F2063; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:096915)

GS0076-043    Chemagro Agricultural Division (1978) Recovery of Bolstar® and
                 Metabolites from Poultry Eggs: Report No. 53098.
                 (Unpublished study received Mar 13, 1978 under 8F2063;
                 submitted by Mobay Chemical Co., Kansas City, MO; CDL:096915)

GS0076-044    Chemonics Industries (1977) Cotton Residue Study: 462-6550-76D
                 Report No. 51354.  (Unpublished study received Jun 22, 1977
                 under 6G1705; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:098051)

GS0076-045    Chemonics Industries (1977) Cotton Residue Study: 462-6559-76D
                 Report No. 51355.  (Unpublished study received Jun 22, 1977
                 under 6G1705; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:098051)

GS0076-046    Chemonics Industries (1977) Cotton Residue Study: 462-6549-76D
                 Report No. 51356.  (Unpublished study received Jun 22, 1977
                 under 6G1705; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:098051)

GS0076-047    Chemonics Industries (1977) Cotton Residue Study: 462-6558-76D
                 Report No. 51357.  (Unpublished study received Jun 22, 1977
                 under 6G1705; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:098051)

GS0076-048    Chemonics Industries (1977) Cotton Residue Study: 462-6551-76D
                 Report No. 51358.  (Unpublished study received Jun 22, 1977
                 under 6G1705; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:098051)

-------
GS0076-049 .
GS0076-050
GS0076-051
GS0076-052
GS0076-053
GS0076-054
GS0076-055
GS0076-056
GS0076-057
Chemonics Industries (1977) Cotton Residue Study: 962-6589-76D
   Report No. 51359.  (Unpublished study received Jun 22, 1977
   under 6G1705; submitted by Mobay Chemical Co., Kansas City,
   MO; CDL:098051)

Chemonics Industries (1977) Cotton Residue Study: 362-6575-76D
   Report No. 51360.  (Unpublished study received Jun 22, 1977
   under 6G1705; submitted by Mobay Chemical Co., Kansas City,
   MO; CDL:098051)

Chemonics Industries (1977) Cotton Residue Study: 761-6555-76D
   Report No. 51361.  (Unpublished study received Jun 22, 1977
   under 6G1705; submitted by Mobay Chemical Co., Kansas City,
   MO; CDL:098051)

Chemonics Industries (1977) Cotton Residue Study: 962-6557-76D
   Report No. 51362.  (Unpublished study received Jun 22, 1977
   under 6G1705; submitted by Mobay Chemical Co., Kansas City,
   MO; CDL:098051)

Chemonics Industries (1977) Cotton Residue Study: 363-6585-76D
   Report No. 51363.  (Unpublished study received Jun 22, 1977
   under 6G1705; submitted by Mobay Chemical Co., Kansas City,
   MO; CDL:098051)

Chemonics Industries (1977) Cotton Residue Study: 962-6590-76D
   Report No. 51364.  (Unpublished study received Jun 22, 1977
   under 6G1705; submitted by Mobay Chemical Co., Kansas City,
   MO; CDL:098051)

Chemonics Industries (1977) Recovery of Bolstar® from Cotton:
   Report No. 51177.  (Unpublished study received Jun 22, 1977
   under 6G1705; submitted by Mobay Chemical Co., Kansas City,
   MO; CDL:098051)

Chemonics Industries (1978) Rotational Crop Study: VBL-6584-76H:
   Report No. 53284. (Unpublished study received Mar 13, 1978
   under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
   CDL:096915)

Chemonics Industries (1978) Soil Persistence Study: KC-6514-74D:
   Report No. 45380. (Unpublished study received Mar 13, 1978
   under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
   CDL:096915)

-------
GS0076-058    Chernonics Industries (1978) Soil Persistence Study: KC-6513-74D:
                 Report No. 45381. (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay1 Chemical Co., Kansas City, MO;
                 CDL:096915)

GS0076-059    Chemonics Industries (1978) Soil Persistence Study: VBL-6515-74D:
                 Report No. 45382. (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:096915)

GS0076-060    Chemonics Industries (1978) Soil Persistence Study: VBL-6516-74D:
                 Report No. 45408. (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:096915)

GS0076-061    Chemonics Industries (1978) Soil Persistence Study: 363-6518-
                 74/76D: Report No. 53376.  (Unpublished study received Mar
                 13, 1978 under 8F2063; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:096915)

GS0076-062    Chemonics Industries (1978) Soil Persistence Study: RGV-6509-75D:
                 Report No. 53376. (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:096915)

GS0076-063    Chemonics Industries (1978) Soil Persistence Study: 363-6503-75D:
                 Report No. 53387. (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:096915)

GS0076-064    Chemonics Industries (1978) Soil Persistence Study: RGV-6501-75D:
                 Report No. 53388. (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:096915)

GS0076-065    Chemonics Industries (1978) Soil Persistence Study: 362-6502-75D:
                 Report No. 53389. (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:096915)

GS0076-066    Chemonics Industries (1978) Soil Residue Study: VBL-6508-75D:
                 Report No. 51214. (Unpublished study received Mar 13, 1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:096915)

-------
GS0076-067    Chemonics Industries  (1978) Soil Residue Study: VBL-6500-75D:
                 Report No.  51379.  (Unpublished  study received Mar 13,  1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas  City, MO;
                 CDL:096915)

GS0076-068    Chemonics Industries  (1978) The Effect of  Frozen Storage  at  0  to
                 -10 degrees F on Bolstar®  Residues in  Soil: Report No.
                 53214.   (Unpublished  study received Mar 13,  1978
                 under 8F2063; submitted by Mobay Chemical Co., Kansas  City, MO;
                 CDL:096915)

GS0076-072    Clark, D.E.;  Ivie, G.W.;  Devaney,  J.A.; Crookshank,  H.R.  (1976)
                 A Gas Chromatographic Method for the Determination of
                 Bolstar® Residues  in  Poultry Tissues and Eggs: Report  No.
                 49973.   (Unpublished  study received Nov 12,  1976  under
                 6G1705;  prepared by Veterinary  Toxicology and Entomology
                 Research Laboratory,  College Station, TX, submitted by
                 Mobay Chemical Co., Kansas City, MO; CDL:095599)

GS0076-074    Close, C.L.  (1975) An Interference Study for the Residue  Method
                 for Bay  NTN 9306 and  Metabolites in Cottonseed: Report No.
                 Report No.  45378.   (Unpublished study received Nov 21,
                 1975 under 3125-EUP-132; submitted by Mobay  Chemical Co.,
                 Kansas City, MO; CDL:094773)

GS0067-075    Close, C.L.  (1975) The Stability of Bay NTN 9306 in  Various
                   Soils Under Frozen Storage:  Report No. 45365.   (Unpublished
                   study received  ?  under  ?; submitted by Mobay Chemical Co.,
                   Kansas  City, MO;  CDL:?)

GS0076-076    Close, C.L.;  Kurtz, S.K.  (1975) A  Confirmatory  Procedure  for the
                 Analytical Method  for Bay NTN 9306  in Cottonseed  and By-
                 Products:  Report No.  45396.   (Unpublished study received
                 Nov 21,  1975 under 3125-EUP-132; submitted by Mobay
                 Chemical Co., Kansas  City, MO;  CDL:094773)

GS0076-077    Craven Laboratories  (1978)  Cottonseed Residue Experiment:
                 RGV-6553-76D: Report  No.  53243.  (Unpublished study  received
                 Mar 13,  1978 under 8F2063; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:096914)

GS0076-078    Craven Laboratories  (1978)  Recovery of Bolstar® from Cotton:
                 Report No.  53007.   (Unpublished study  received Mar 13, 1978
                 under 8F2063; submitted  by Mobay Chemical Co., Kansas  City,
                 MO; CDL:096914)

-------
GS0076-081    Fink, R. (1979) Acute Oral LD50-Bobwhite Quail-Bolstar
                 Technical Final Report.  (Unpublished study received Oct  15,
                 1979 under ?; prepared by Wildlife International, Ltd.,
                 submitted by Mobay Chemical Co., Kansas City, MO; CDL:241165)

GS0076-082    Fink, R. (1979) One-generation Reproduction Study- Bobwhite  Quail-
                 Bolstar Technical.  (Unpublished study received Oct 15, 1979
                 under ?; prepared by Wildlife International, Ltd., submitted
                 by Mobay Chemical Co., Kansas City, MO; CDL:241165)

GS0076-083    Flint, D.R. (1975) Excretion and Metabolism of Bay NTN 9306  in
                 Poultry: Report No. 45360.  (Unpublished study received
                 Nov 21, 1975 under 3125-EUP-132; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:094773)

GS0076-084    Gronberg, R.R. (1978) The Persistence and Metabolite Distribution
                 of Bolstar® Residues in Kansas Clay Soil Following Applica-
                 tion of Bolstar 6 EC: Report No. 63022.  (Unpublished study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

GS0076-089    Groning, P. (1975) Effect on Cholinesterase- Bay NTN 9306:
                 Report No. 45159.  (Unpublished study received Nov 21,
                 1975 under 6G1705; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:094772t

GS0076-091    Groning, P.; Dieckman, W. (1975) Subacute Oral Toxicity Study
                 on Rats: Report No. 43850.  (Unpublished study received
                 Nov 21, 1975 under 6G1705; submitted by Mobay Chemical
                 Co., Kansas City, MO; CDL:094772)

GS0076-092    Groning, P.; Kimmerle, G. (1975) Toxicity Studies- Bay NTN 9306:
                 Report No. 41462.  (Unpublished study received Nov 21,
                 1975 under 6G1705; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:094772)

GS0076-093    Hanks, A.R. (1980) Report on pesticide formulations:
                 Organophosphorus pesticides. J. Assoc. Off. Anal. Chem.
                 63(2):228-229.

GS0076-095    Hazelton Laboratories America, Incorporated (1978) A Three Gener-
                 ation Reproduction Study in Rats, NTN 9306, Final Report:
                 Project No. 339-106; Report No. 53882. (Unpublished study
                 received ? under 8F2063; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:096916)

-------
GS0076-096    Huddleston, E.W.  (1975)  [Cotton Residue Reports: Report No.
                45399.]  (Unpublished  study received Nov  21,  1975  under  6G1705;
                submitted by Mobay Chemical Co., Kansas  City, MO;  CDL:0954773)

GS0076-098    Ivie, G.W.; Bull,  D.L.  (1976) Photodegradation of 0-Ethyl 0-
                  [4-(Methylthio)phenyl]S-Propyl Phosphorodithioate (Bay NTN
                  9306).  J. Agric. Food Chem. 24  (5): 1053-1057.  (Also   In
                  unpublished report no. 48083 received ? under ?;  submitted
                  by Mobay Chemical Co., Kansas City, MO; CDL:?)

GS0076-099    Ivie, G.W.; Bull,  D.L.; Witzel, D.A.  (1975) The Metabolic Fate  of
                  Bay NTN 9306-ring-UL-  C  in a Lactating Cow: Report No.
                  44325.   (Unpublished study received Nov 1,  1975  under
                  6G1705; prepared by  Cotton Insects Research Laboratory,
                  College Station, TX, submitted by Mobay Chemical Co.,  Kansas
                  City, MO; CDL:095559)

GS0076-101    Johansen,  C.; Mayer, D.; Madsen, R.; Curtis, J.; The Alfalfa
                   Seed Pest Management Project.   (1975)  Bee  Research
                   Investigations, 1974. Unpublished Report.

GS0076-102    Kimmerle,  G.  (1975) Acute Inhalation Toxicity  Study on Rats:
                  Report  No. 44224.   (Unpublished  study received Nov 21,
                  1975 under 6G1705; submitted by Mobay Chemical Co., Kansas
                  City, MO; CDL:094772)

GS0076-103    Kimmerle,  G.  (1975) Subacute Inhalation Toxicity Study on Rats:
                  Report  No. 44222.   (Unpublished  study received Nov 21,
                  1975 under 6G1705; submitted by  Mobay Chemical Co., Kansas
                  City, MO; CDL:094772)

GS0076-106    Kurtz, S.K.; Gronberg,  R.R.  (1975) The Mobility of  Bay NTN 9306
                  in Soil Runoff Water:  Report No. 45341.   (Unpublished
                  study received Nov 1, 1975 under 6G1705; submitted by
                  Mobay Chemical Co.,  Kansas City, MO; CDL:095559)

GS0076-108    LaBlanc, B.; Marcullier, A.; Tranin, E.; Hainan, J.; Costin, P.
                  (1975)  Effect of Bay NTN  9306 on Soil Microbial  Populations:
                  Report  No. 45326.   (Unpublished  study received Nov 1,
                  1975 under 6G1705; submitted by The Barstow School, Kansas
                  City, MO; submitted  by Mobay Chemical Co.,  Kansas City, MO;
                  CDL:095559)

-------
GS0076-115
GS0076-109    Lamb, D.W. (1975) Bay NTN 9306 Subchronic 90-Day Feeding Study on
                 Rats: Report No. 45389.  (Unpublished study received Nov
                 21, 1975 under 6G1705; submitted by Mobay Chemical Co.,  Kansas
                 City, MO; CDL:094772)

GS0076-110    Lamb, D.W. (1975) Bay NTN 9306 Subchronic 90-Day Feeding Study on
                 Dogs: Report No. 45392.  (Unpublished study received Nov
                 21, 1975 under 6G1705; submitted by Mobay Chemical Co.,  Kansas
                 City, MO; CDL:094772)

GS0076-114    Lamb, D.W. (1978) Bolstar®  (Bay NTN 9306) Chronic Feeding
                 Study on Rats: Report No. 63058. (Unpublished study received
                 Mar 13, 1978 under 8F2063; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:096916)

              Lamb, D.W. (1978) Bolstar®  (Bay NTN 9306) Chronic Feeding
                 Study on Mice: Report No. 63059. (Unpublished study received
                 Mar 13, 1978 under 8F2063; submitted Mobay Chemical Co.y
                 Kansas City, MO; CDL:096917)

GS0076-117    Lamb, D.W. (1978) Bolstar®  (Bay NTN 9306) Two-Year Feeding
                 Study on Beagle Dogs: Report No. 63100.  (Unpublished study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096917)

GS0076-118    Lamb, D.W.; Anderson, R.H.  (1976) Skin Sensitization of Bay NTN
                 9306 Technical in Guinea Pigs: Report No. 46009.   (Unpublished
                 study received Nov 12, 1976 under 3125-EUP-132; submitted
                 by Mobay Chemical Co., Kansas City, MO; CDL:095598)

GS0076-119    Lamb, D.W.; Jones, R.E.  (1975) Acute Oral Toxicity of Bay NTN
                 9306 Technical to Adult Mallard Ducks.  Report No. 44361.
                 (Unpublished study received ? under 6G1705; submitted by
                 Mobay Chemical Co., Kansas City, MO; CDL:?)

GS0076-120    Lamb, D.W.; Jones, R.E.  (1975) Dietary Toxicity of Bay NTN
                 9306 Technical to Bobwhite Quail and Mallard Ducks: Report
                 No. 45327.  (Unpublished study received Nov 21, 1975
                 under 6G1705; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:094772)

GS0076-121    Lamb, D.W.; Matzkanin, C.S. (1975) Bay NTN 9306 6  (Emulsifiable)
                 Subacute Dermal Toxicity to Rabbits: Report No. 45415.
                 (Unpublished study received Nov 21, 1975 under 6G1705;
                 submitted by Mobay Chemical Co., Kansas City, MO; CDL:094772)

-------
GS0076-122    Lamb, D.W.; Matzkanin, C.S.  (1975) The Acute Dermal Toxicity
                 of Bay  NTN  9306  (Technical): Report No.  45393.
                 (Unpublished study received Nov 21, 1975 under  6G1705;
                 submitted by Mobay Chemical Co., Kansas  City, MO;  CDL:094772)

GS0076-123    Lamb, D.W.; Matzkanin, C.S.  (1975) The Acute Dermal Toxicity of
                 Bay NTN 9306 6  (Emulsifiable): Report No. 45397.
                 (Unpublished study received Nov 21, 1975 under  6G1705;
                 submitted by Mobay Chemical Co., Kansas  City, MO;  CDL:094772)

GS0076-124    Lamb, D.W.; Matzkanin, C.S.  (1975) The Acute Inhalation Toxicity
                 of Bay  NTN  9306  6  (Emulsifiable):  Report No.  45394.
                 (Unpublished study received Nov 21, 1975 under  6G1705;
                 submitted by Mobay Chemical Co., Kansas  City, MO;  CDL:094772)

GS0076-125    Lamb, D.W.; Matzkanin, C.S.  (1975) The Acute Oral  Toxicity of
                 Bay NTN 9306 Technical:  Report No. 45376.
                 (Unpublished study received Nov 21, 1975 under  6G1705;
                 submitted by Mobay Chemical Co., Kansas  City, MO;  CDL:094772)

GS0076-126    Lamb, D.W.; Matzkanin, C.S.  (1975) The Acute Oral  Toxicity of
                 Bay NTN 9306 Technical to Rats: Report No.  45377.
                 (Unpublished study received Nov 21, 1975 under  6G1705;
                 submitted by Mobay Chemical Co., -Kansas  City, MO;  CDL:094772)

GS0076-127    Lamb, D.W.; Matzkanin, C.S.  (1975) The Acute Oral  Toxicity of
                 Bay NTN 9306 6  (Emulsifiable): Report No. 45395.
                 (Unpublished study received Nov 21, 1975 under  6G1705;
                 submitted by Mobay Chemical Co., Kansas  City, MO;  CDL:094772)

GS0076-128    Lamb, D.W.; Matzkanin, C.S.  (1975) The Dermal  Irritancy of Bay
                 NTN 9306 6  (Emulsifiable): Report  No. 45416.   (Unpublished
                 study received Nov 21, 1975 under  6G1705; submitted
                 by Mobay Chemical Co., Kansas City, MO;  CDL:094772)

GS0076-129    Lamb, D.W.; Matzkanin, C.S.  (1975) The Eye  Irritancy  of Bay
                 NTN 9306 6  (Emulsifiable): Report  No. 45417.   (Unpublished
                 study received Nov 21, 1975 under  6G1705; submitted
                 by Mobay Chemical Co., Kansas City, MO;  CDL:094772)

GS0076-130    Lamb, D.W.; Matzkanin, C.S.  (1978) The Acute Oral  of
                 Bay NTN 9306 Technical:  Report No. 46160.   (Unpublished study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas  City, MO; CDL:096916)

-------
GS0076-131    Lamb, D.W.; Matzkanin, C.S.  (1978) The Acute Oral  of
                 Bay NTN 9306 Technical: Report No. 46161.   (Unpublished  study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096916)

GS0076-132    Lamb, D.W.; Matzkanin, C.S.  (1978) The Acute Oral of Bolstar®
                 (formally Bay NTN 9306) Metabolite PSS02  (Sulfone) to
                 Sprague-Dawley Rats: Report No. 52881.   (Unpublished study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096916)

GS0076-133    Lamb, D.W.; Matzkanin, C.S.  (1978) The Acute Oral of Bolstar®
                 (formally Bay NTN 9306) Metabolite POS02  (Oxygen Analog
                 Sulfone) to Sprague-Dawley Rats: Report No. 52882.
                 (Unpublished study received Mar 13, 1978 under 8F2063;
                 submitted by Mobay Chemical Co., Kansas City, MO; CDL:096916)

GS0076-134    Lamb, D.W.; Matzkanin, C.S.  (1978) The Acute Oral of Bolstar®
                 (formally Bay NTN 9306) Metabolite PSSO  (Sulfoxide) to
                 Sprague-Dawley Rats: Report No. 52883.   (Unpublished study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096916)

GS0076-135    Lamb, D.W.; Matzkanin, C.S.  (1978) The Acute Oral of Bolstar®
                 (formally Bay NTN 9306) Analytical Standard (PSS) to
                 Sprague-Dawley Rats: Report No. 52884.   (Unpublished study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096916)

GS0076-136    Lamb, D.W.; Matzkanin, C.S.  (1978) The Acute Oral of Bolstar®
                 (formally Bay NTN 9306) Metabolite POS  (Oxygen Analog) to
                 Sprague-Dawley Rats: Report No. 52885.   (Unpublished study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096916)

GS0076-137    Lamb, D.W.; Matzkanin, C.S.  (1978) The Acute Oral of Bolstar®
                 (formally Bay NTN 9306) Metabolite POSO  (Oxygen Analog
                 Sulfoxide) to Sprague-Dawley Rats: Report No. 52886.
                 (Unpublished study received March 13, 1978  under 8F2063;
                 prepared by Mobay Chemical Co., Kansas City, MO; CDL:096916)

GS0076-138    Lamb, C.D.; Roney,  D.J. (?)  Acute Toxicity  of  Bay NTN 9306
                 6 Ib/gal EC to Bluegill,  Channel Catfish, and Rainbow Trout.
                 Report No. 45330.   (Unpublished study received ? under  ?;
                 submitted by Mobay Chemical, Co., Kansas City, MO; CDL:?)

-------
GS0076-139
GS0076-140
GS0076-141
GS0076-142
GS0076-143
GS0076-144
GS0076-145
GS0076-146
Lamb, D.W.; Roney, D.J. (1975) Accumulation and Persistence of
   Residues in Channel Catfish Exposed to Bay NIN 9306-  C:
   Report No. 45331.   (Unpublished study received Nov 1,
   1975 under 6G1705; submitted by Mobay Chemical Co., Kansas
   City, MO; CDL:095559)

Machemer, L. (1975) Dominant Lethal Study on Male Mice to Test
   for Mutagenic Effects: Report No. 45385. (Unpublished study
   received Nov 21, 1975 under 6G1705; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:094772)

Machemer, L. (1975) Studies for Embryotoxic and Teratogenic
   Effects on Rabbits Following Oral Administration: Report No.
   45386. (Unpublished study received Nov 21, 1975 under
   6G1705; submitted by Mobay Chemical Co., Kansas City, MO;
   CDL:094772)

McGreavy, J.P.; Swan, J.L.; Mayor, W.P. (1975) Stability of Bay
   NTN 9306 6 (Emulsifiable): Report No. 45391.  (Unpublished
   study received Nov 21, 1975 under 3125-EUP-132; submitted
   by Mobay Chemical Co., Kansas City, MO; CDL:094771)

McNamara, F.T.  (1978) Microbial Degradation of Bolstar®.
   Report No. 63032.   (Unpublished study received Mar 13, 1978
   under 8H5182; submitted Mobay Chemical Corp., Kansas City, MO;
   CDL:096915)
                                     TM
Minor, R.G.  (1978) Effect of Bolstar    on Isolated Soil
   Microorganisms:  Report No. 54434.   (Unpublished study
   received Mar 13, 1978 under 8H5182; submitted by Mobay Chemical
   Co. Kansas City, MO; CDL:096915)

Minor, R.G.  (1978) Effects of Bolstar® on Nitrogen Fixation:
   Report No. 54477.   (Unpublished study received Mar 13, 1978
   under 8H5182; submitted by Mobay Chemical Corp., Kansas City,
   MO; CDL:096915)

Mobay Chemical Corporation  (?) Recovery of Bay NTN 9306 From
   Cattle Tissues and Milk:  Report No. 45355.   (Unpublished
   study received ? under ?; submitted by Mobay Chemical Co.,
   Kansas City, MO; CDL:?)

-------
GS0076-147    Mobay Chemical Corporation (1975)  [Cotton Residue Reports:
                 Report No. 45405.]  (Unpublished study received Nov  21,  1975
                 under 6G1705; prepared by Vero Beach Laboratories,  Chemagro
                 Chemical Corp., submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:094773)

GS0076-148    Mobay Chemical Corporation (1975)  [Cotton Residue Reports:
                 Report No. 45406.]  (Unpublished study received Nov  21,  1975
                 under 6G1705; prepared by Vero Beach Laboratories,  Chemagro
                 Chemical Corp., submitted by Mobay Chemical Co., Kansas  City,
                 MO; CDL:094773)

GS0076-149    Mobay Chemical Corporation (1975) General Product Chemistry Data.
                 (Unpublished study received Nov 13, 1975 under 3125-EUP-132;
                 submitted by Mobay Chemical Corp., Kansas City, MO;
                 CDL:095052)

GS0076-150    Mobay Chemical Corporation (1975) Name, Chemical Identity  and
                 Composition of Pesticide Petition No. 6G1705.   (Unpublished
                 study received  Nov 13, 1975 under 6G1805; submitted by
                 Mobay Chemical Corp., Kansas City, MO; CDL:094771)

GS0076-151    Mobay Chemical Corporation (1975) Recovery of Bay NTN  9306  From
                 Soil:  Report No. 45353.  (Unpublished study received ?  under
                 ?; submitted by Mobay Chemical Co., Kansas City, MO; CDL?)

GS0076-152    Mobay Chemical Corporation (1976) Bolstar® Emulsifiable
                 Insecticide- Application for Extension of Experimental  Use
                 Permit on Cotton.   (Unpublished study received Nov  12,
                 1976 under 3125-EUP-132; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:095597)

GS0076-154    Mobay Chemical Corporation (1976) Letter sent to W.R.  Bontoyan
                 dated Apr 27, 1976.   [Accompanying this letter were 2 grams
                 of primary standard and 20 grams  of technical material.]

GS0076-155    Mobay Chemical Corporation (1978) Bolstar® in or on Cottonseed
                 Meat (Fat and Meat By-products of Cattle, Goats,  Hogs,
                 Horses, Poultry, and Sheep), Milk and Eggs.   (Unpublished
                 study received Mar 13, 1978 under 8H5182; submitted by
                 Mobay Chemical Co., Kansas City,  MO; CDL:096913)

-------
GS0076-156
GS0076-158
GS0076-159
GS0076-160
GS0076-162
GS0076-163
GS0076-164
GS0076-165
Mobay Chemical Corporation (1978) Supplement No. 1 to Additional
   Field Rotational Crop Data, Use on Cotton, 12.04 Environmental
   Chemistry: Report No. AS78-1424.  (Unpublished study received
   July 19, 1978 under 8F2063; submitted by Mobay Chemical Co.,
   Kansas City, MO; CDL:097218)

Morris, R.A.  (1978) Determination of Baygon®, Baytex®,
   Bolstar®, Croneton®, Dasanit®, Di-Syston®, Dylox®,
   Guthion®, Hinosan®, Mesurol®, Metasystox-R®, Monitor®,
   Morestan®, Nemacur®, and Systox® Residues in Soil: Report No.
   49675.   (Unpublished study received Mar 13, 1978 under
   8F2063; submitted by Mobay Chemical Co., Kansas City, MO;
   CDL:096915)

Morris, R.A.; Sandie, F.E.; Gronberg, R.R.  (1978) A Gas Chromato-
   graphic Method  for the Determination of Bolstar® and Metab-
   olite Residues  in Corn: Report No. 53114.   (Unpublished study
   received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

Morrissey, A.E. (1979) The Acute -Toxicity of Bolstar Technical to
   to the Water Flea Daphnia magna Strain.  Report No. 68161.
   (Unpublished study received Oct 15, 1979 under ?; prepared by
   Union Carbide Environmental Services, submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:241165)

Nash, R.F.  (1975)  [Cotton Residue Reports: Report No. 45401.]
   (Unpublished study received Nov 21, 1975 under 6G1705;
   submitted  by Mobay Chemical Co., Kansas City, MO; CDL:094773)

Nelson, D.  (1979)  Acute Toxicity of Bolstar Technical to Bluegill
   and Rainbow Trout.   (Unpublished study received Oct 15, 1979
   under ?; submitted by Mobay Chemical Co., Kansas City, MO;
   CDL:241165)

Nelson, D.  (1979)  Acute Toxicity of Bolstar Technical to
   Daphnia magna.   (Unpublished study received Oct 15, 1979
   under ?; submitted by Mobay Chemical Co., Kansas City, MO;
   CDL:241165)

Patel, Y.  (1976) The Composition of Bay NTN  9306: Report No.
   45430.   (Unpublished study received Nov  21, 1975 under
   3125-EUP-132; submitted by Mobay Chemical Co., Kansas City,
   MO; CDL:094771)                                         *

-------
GS0076-166    Pither, K.M.  (1976) The Stability of Bay NTN  9306  in  Poultry
                 Tissue and Eggs During Frozen Storage: Report No.  46992.
                 (Unpublished study received Nov 12, 1976 under
                 6G1705; submitted by Mobay Chemical Co., Kansas City,
                 Mo; CDL:095599)

GS0076-167    Pither, K.M.  (1978) The Effect of Natural Environmental on the
                 Persistence and Metabolism of BOLSTAR®
                 Incorporated in Florida Sandy Soil:  Report No.  54392.
                 (Unpublished study received Mar 13, 1978 under  8H5182;
                 submitted by Mobay Chemical Co., Kansas City, MO:  CDL:096915)

GS0076-168    Pither, K.M.; Gronberg, R.R. (1975) The Metabolism of Bay NTN
                 9306 in Swine: Report No. 44626.   (Unpublished  study received
                 Nov 21, 1975 under 3125-EUP-132; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:094773)

GS0076-169    Pither, K.M.; Gronberg, R.R. (1976) An Interference Study for the
                 Analytical Residue Method for Bay NTN 9306 and  Metabolites in
                 Bovine Tissues and Milk and in Poultry Tissues  and Eggs:
                 Report No. 46993.   (Unpublished study received  Nov 12,
                 1976 under 6G1705; submitted by Mobay Chemical  Co., Kansas
                 City, MO; CDL:095599)

GS0076-170    Rowehl, E.  (1975)  [Cotton Residue Reports: Report  No. 45403.]
                 (Unpublished study received Nov 21, 1975 under  6G1705;
                 submitted by Mobay Chemical Co., Kansas City, MO;  CDL:094773)

GS0076-171    Rowehl, E.  (1975)  [Cotton Residue Reports: Report  No. 45404.]
                 (Unpublished study Received Nov 21, 1975 under  6G1705;
                 submitted by Mobay Chemical Co., Kansas City, MO;  CDL:094773)

GS0076-172    Sandie, F.E.  (1975) A Gas Chromatographic Method for  the
                 Determination of Bay NTN 9306 and Metabolites in Cottonseed
                 and By-Products: Report No. 45372.   (Unpublished study
                 received Nov 21, 1975 under 6G1705; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:094773)

GS0076-173    Sandie, F.E.  (1978) Residues in Rational Crops Following a Crop
                 Treated with Bolstar-Ring-UL-  C 6 EC  Incorporated in  Sandy
                 Soil at Planting: Report No. 63020.   (Unpublished  study
                 received Mar 13, 1978 under 8F2063; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:096915)

-------
GS0076-174
GS0076-175
GS0076-176
GS0076-177
GS0076-178
GS0076-181
GS0076-182



GS0076-183


GS0076-184
Sandie, F.E.; Gronberg, R.R. (1975) A Gas Chromatographic Method
   for the Determination of Bay NTN 9306 Residues  in Bovine
   Tissue and Milk: Report No. 45367.   (Unpublished study
   received Nov 1, 1975 under 6G1705; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:095559)

Sandie, F.E.; Gronberg, R.R. (1975) A Gas Chromatographic Method
   for the Determination of Bay NTN 9306 and Metabolites in
   Cottonseed and By-Products: Report 453372   (Unpublished study
   received Mar 13, 1978 under 8F2063; submitted by Mobay
   Chemical Co., Kansas City, MO; CDL:096915)

Scott, A. (1975)  [Cotton Residue Reports:  Report  No. 45398.]
   (Unpublished study  received Nov 21,  1975 under  6G1705;
   submitted by Mobay  Chemical Co., Kansas City, MO; CDL:094773)
                      (
Strankowski, K.J.  (1978) Effects of Bolstar® on Nitrification
   and Denitrification in Soil:  Report No. 54431.   (Unpublished
   study received Mar  13, 1978 under 8H5182; submitted by Mobay
   Chemical Corp., Kansas City, MO; CDL:096915)

Synek, J.; Gonzalez, J.A. (1975) Storage Stability of Bay NTN
   9306- Technical Material and 6 Emulsifiable: Report No. 44127.
   (Unpublished study  received Nov 1, 1975 under
   3125-EUP-132; submitted by Mobay Chemical Co.,  Kansas City,
   MO; CDL:095052)

Thyssen, J.; Siegmund, F. (1975) Neurotoxicity Studies on Hens-
   Bay NTN 9306: Report No. 43823.   (Unpublished study received
   Nov 21, 1975 under  6G1705; submitted by Mobay Chemical
   Co., Kansas City, MO; CDL:094772)

Ward, C.R. (1975)  [Cotton Residue Reports:  Report No. 45400.]
   (Unpublished study  received Nov 21, 1975 under  6G1705;
   submitted by Mobay  Chemical Co., Kansas City, MO; CDL:094773)

Weiler, E. (1981) Memo sent to William Phillips dated Feb 4,
   1981.  [Preliminary estimates of use of Sulprofos (Bolstar®)]

Weiler, E.; Lin, Y.; Bieber, J. (1981) Preliminary Benefit
   Analysis of EPN Use on Cotton.  (A report submitted Apr 15,
   1981 by the Mississippi State University Pesticide Assessment
   Team)

-------
GS0076-185    Wildlife International, LTD.  (1978) Mallard Duck Reproduction
                 Study. (Unpublished study  received Sep 15, 1978 under
                 8F2063; submitted by Mobay Chemical Corporation, Kansas City,
                 MO; CDL:097395)

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

GS0076-029    Boyd, W.G., Jr. (1979) Gas-liquid chromatography of Bolstar
                 formulations.  J. Asso. Off. Anal. Chem. 62(4):742-745.

GS0076-030    Boyd, W.G., Jr.  (1980) Gas-liquid chromatographic method for
                 determining bolstar insecticide in formulations:
                 Collaborativestudy.  J. Assoc. Off. Anal. Chem. 62  (1):120-
                 127.

GS0076-031    Buck, N.A.; Estesen, B.J.; Ware, G.W.(1980) Dislodgable
                 insecticide residues on cotton foliage:  Fenvalarate  (sic),
                 permethrin, sulprofos, chlorpyrifos, methyl parathion, EPN,
                 oxamyl, and profenofos.  Bulletin of Environmental
                 Contamination and Toxicology 24(2):283-288.

GS0076-033    Bull, D.L.; Ivie, G.W. (1976) Metabolism of 0-ethyl 0-(4-
                 (methylthio)phenyl) S-propyl phosphorodithioate (Bay  NTN  9306)
                 by white rats.  Journal of Agricultural and Food Chemistry
                 24(1):143-146.

              Bull, D.L.; Whitten, C.J.; Ivie, G.W. (1976) Fate of 0-ethyl 0-(4-
                 (methylthio)phenyl) S-propyl phosphorodithioate (BAY  NTN  9306)
                 in cotton plants and soil. J. Agric. Food Chem. 24((3):601-
                 605.

GS0076-042    Chemagro Agricultural Division (1978) Recovery of Bolstar® and
                 Metabolites from Poultry Tissues: Report No. 53097.
                 (Unpublished study received Mar 13, 1978 under 8F2063;
                 submitted by Mobay Chemical Co., Kansas City, MO; CDL:096915)

GS0076-069    Ciarletta, J.A. (1975) The Comparative Phytotoxicities From
                 Bayer and Chemagro Formulations of Bay NTN 9306 6 EC  Applied
                 Folier to Cotton: Report No. 33843.  (Unpublished study
                 received Nov 21,1975 under 3125-EUP-132; submitted  by
                 Mobay Chemical Co., Kansas City, MO; CDL:094794)

GS0076-070    Ciarletta, J.A. (1975) The Comparative Phytotoxicities From
                 Bayer and Chemagro Formulations of Bay NTN 9306 6 EC  Applied
                 Folier to Cotton Following 24 Week Storage Stability  Trials:
                 Report No.  33885.   (Unpublished study received Nov  21, 1975
                 under  3125-EUP-132; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:094794)
GS0076-035

-------
GS0076-071    Clark, D.E.; Crookshank, H.R.;  Devaney, J.A.;  Bull,  D.L.;  Ivie,
                 G.W.  (1979) Effects of  sulprofos  and its  sulfoxide and  sulfone
                 metabolites on  laying hens fed  the  compounds  in the diet.  J.
                 Agric.  Food Chem.  27(1):103-107.

GS0076-073    Clark, D.E.; Ivie, G.W.; Devaney,  J.A.; Crookshank,  H.R.  (1976)
                 Effects of Bolstar®  and its  Sulfoxide  and Sulfone Metab-
                 olites  on Laying Hens Fed  the Compound in the Diet: Report No.
                 48180.   (Unpublished study received Nov 12, 1976 under
                 6G1705; prepared by Veterinary  Toxicology and Entomology
                 Research Laboratory, College Station,  TX;  submitted by
                 Mobay Chemical  Co., Kansas City,  MO; CDL:095599)

GS0076-079    Estesen, B.J., Buck,  N.A.; Ware, G.W.  (1979)  Dislodgable
                 insecticide residues on cotton  foliage:   Permethrin, curacron,
                 fenvalarate,  sulprofos, decis,  and  endosulfan.  Bulletin of
                 Environmental Contamination  and Toxicology 22 (1-2):245—248.

GS0076-080    Estesen, B.J.; Buck,  N.A.; Ware, G.W..  (1979)  Dislodgable
                 insecticide residues on cotton  foliage:   Permethrin, curacron,
                 fenvalarate,  sulprofos, decis and endosulfan.  Bulletin of
                 Environmental Contamination  and Toxicology 22 (1-2):256.

GS0076-085    Gronberg,  R.R.;  Sandie, F.E.  (1975)  Analysis of Bay NTN 9306 and
                 Its Stability in Alfalfa Pellets: Report  No.  45368.
                  (Unpublished  study received  Nov 1,  1975 under 6G1705;
                 submitted by  Mobay Chemical  Co.,  Kansas City, MO; CDL:095559)

GS0076-086    Gronberg,  R.R.;  Wilkes, L.C.  (1978)  The Metabolism of Bolstar®
                 in Corn: Report No.  54066.   (Unpublished  study received
                 Mar 13, 1978  under 8F2063; submitted by Mobay Chemical  Co.,
                 Kansas  City,  MO; CDL:096915)

GS0076-087    Gronberg,  R.R.;  Wilkes, L.C.  (1978)  The Metabolism of Bolstar®
                 in Tomatoes:  Report  No. 53669.   (Unpublished study received
                 Mar 13, 1978  under 8F2063; submitted by Mobay Chemical  Co.,
                 Kansas  City,  MO; CDL:096915)

GS0076-088    Gronberg,  R.R.;  Wilkes, L.C.  (1978)  The Stability of Bolstar®
                 in Tomatoes and Corn Forage, Husk,  Cob, and Kernels under
                 Frozen  Storage: Report No. 54064.  (Unpublished study received
                 Mar 13, 1978  under 8F2063; submitted by Mobay Chemical  Co.,
                 Kansas  City,  MO;  CDL:096915)

-------
GS0076-090    Groning, P. (1975) Study to Investigate Combination Toxicity:
                 Report No. 45161.   (Unpublished study received Nov  21,
                 1975 under 6G1705; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:094772)

GS0076-094    Hazelton Laboratories America, Incorporated  (1976) A Three-
                 Generation Reproduction Study in Rats-A Preliminary Report:
                 No. 49669.   (Unpublished study received Nov 12, 1976 under
                 3125-EUP-132; submitted by Mobay Chemical Co., Kansas City,
                 Mo; CDL:095598)

GS0076-097    Ivie, G.W.; Bull, D.L.  (1976) Photodegradation of 0-Ethyl O-
                  [4-(Methylthio)phenyl]S-Propyl Phosphorodithioate  (Bay NTN
                 9306)  J. Agric. Food Chem. 24(5):1053-1057.

GS0076-100    Ivie, G.W.; Bull, D.L.; Witzel, D.A. (1976) Metabolic  fate of  0-
                 ethyl 0-(4-(methylthio)-phenyl-14-C) S-propyl
                 Phosphorodithioate  (BAY NTN 9306) in a lactating cow.  J.
                 Agric. Food  Chem 24(1):147-151.

GS0076-104    Kishino, S.; Kudamatsu, A.; Takase, I.; Shiokawa, K.;  Yamaguchi,
                 S., inventors; Bayer Aktiengesellschaft, assignee  (1974) O-
                 ethyl-S-propyl-dithiophosphoric acid phenyl or naphthyl
                 esters. U.S. patent  3,947,529. Mar 30. 20 p. Int. C1.2 C C07F
                 9/12.

GS0076-105    Kurtz, S.K.; Gronberg, R.R. (1975) A Gas Chromatographic Method
                 for the Determination of Bay NTN 9306 and Metabolites in Soil
                 and Water: Report No. 45311.  (Unpublished study
                 received Nov 1, 1975 under 6G1705; submitted by Mobay
                 Chemical Co., Kansas City, MO; CDL:095559)

GS0076-107    Kurtz, S.K.; Sandie, F.E. (1975) A Gas Chromatographic Method  for
                 the Determination of Bay NTN 9306 and Metabolites in Soil:
                 Report No. 45356.   (Unpublished study received Nov  1,
                 1975 under 6G1705; submitted by Mobay Chemical Co., Kansas
                 City, MO; CDL:095559)

GS0076-111    Iamb, D.W. (1976) Bolstar®  (Bay NTN 9306) Chronic Two-Year
                 Feeding Study on Beagle Dogs (One-Year Progress Report):
                 Report No. 49913.   (Unpublished study received Nov  12,
                 1976 under 3125-EUP-132; submitted by Mobay Chemical Co.,
                 Kansas City, MO; CDL:095598)

-------
GS0076-112    Lamb, D.W.  (1976)  Bolstar® (Bay NTN 9306) Chronic Two-Year
                 Feeding  Study on Rats (One-Year Progress Report): Report No.
                 49914.   (Unpublished study received Nov 12, 1976 under
                 3125-EUP-132; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:095598)

GS0076-113    Lamb, D.W.  (1976)  Bolstar® (Bay NTN 9306) Chronic Two-Year
                 Feeding  Study on Mice (Six-Month Progress Report): Report No.
                 49915.   (Unpublished study received Nov 12, 1976 under
                 3125-EUP-132; submitted by Mobay Chemical Co., Kansas City, MO;
                 CDL:095598)

GS0076-116    Lamb, D.W.  (1978)  Bolstar® (Bay NTN 9306) Ten-Month Feeding
                 Study with Mice: Report No. 49998. (Unpublished study received
                 Mar 13,  1978 under 8F2063; submitted by Mobay Chemical Co.,
                 Kansas  City, MO; CDL:096917)

GS0076-153    Mobay Chemical  Corporation (1976) Fish and Wildlife Safety of
                 Bolstar®-Progress Report.   (Unpublished study received
                 Nov 12,  1976 under 6G1705; submitted by Mobay Chemical
                 Co.,  Kansas  City, MO; CDL:095600)

GS0076-157    Morris,  R.A.  (1978) A Confirmatory Procedure for the Analytical
                 Residue Method for Bolstar® in Soil: Report No. 50870.
                  (Unpublished study received Mar 13, 1978 under 8F2063;
                 submitted  by Mobay Chemical Co., Kansas City, MO; CDL:096915)

GS0076-161    Nash, R.F.  (1975) Bay NTN 9306 Phytotoxicity on Cotton: Report
                 No. 39323.   (Unpublished study received Nov 21, 1975 under
                 3125-EUP-132; submitted by Mobay Chemical Co., Kansas City,
                 MO; CDL:094794)

GS0076-179    Thornton,  J.S.; Hurley, J.B.; Obrist, J.J.  (1978) Soil Thin-Layer
                 Mobility of  Twenty Four Pesticides Chemicals: Report No.
                 51016.  (Unpublished study received Mar 13, 1978 under 8F2063
                 submitted  by Mobay Chemical Co., Kansas City, MO; CDL:096915)

GS0076-180    Thyssen, J. (1976) Antidotal Effect of Atropine, Fralidoxime,
                 and Obidoxime on NTN 9306- Poisoned Rats: Report No. 47936.
                  (Unpublished study received Nov 12, 1976 under
                 3125-EUP-132; submitted by Mobay Chemical Co., Kansas City,
                 Mo; CDL:095598)
* U.S. GOVERNMENT PRINTING OFFICE:1981—341-082/* 253

-------