&EPA
'Jnited States
Environmental Protection
Agency
Office of
Pesticides and Toxic Substances
Washington OC 20460
September 1980
Pesticides
0,0,0,0-Tetrapropyl
dithiopyrophosphate
Aspon
Pesticide Registration
Standard
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0,0,0,0-TETRAPROPYL DITHIOPYROPHOSPHATE
ASPOIT*
Pesticide Registration Standard
Patrick Miller
John Bascietto
Charlotte Blalock
Padma Datta
Roland Gessert
Steve Hopkins
William Miller
Randall Norris
Ingrid Sunzenauer
Project Manager (SPRD)
Wildlife Biologist (BED)
Residue Chemist (BED)
Environmental Chemist (BED)
Toxicologist (BED)
Plant Physiologist (BED)
Product Manager (RD)
Writer/Editor (SPRD)
Entomologist (BFSD)
September 1980
Office of Pesticides and Toxic Substances
Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
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REGISTRATION STANDARD FOR ASPO
CONTENTS
Page
How to Register Under a Registration Standard 1
Regulatory Position 9
MANUFACTURING-USE ASPON®
I. Regulatory Position 25
A. Regulatory Decision 25
B. Criteria for Registration Under the
Standard 25
C. Acceptable Ranges and Limits 26
1. Product Composition Standards 26
2. Acute Toxicity Limits 27
3. Use Patterns 27
D. Data Gaps 27
E. Required Labeling 29
1. Product Chemistry 29
2. Human Hazard - Precautionary Labeling.... 30
3. Environmental Hazards 30
4. Physical or Chemical Hazards 30
5. Use Patterns 31
II. Regulatory Rationale 33
A. Regulatory Decision 33
B. Acceptable Ranges and Limits 33
1. Product Composition Standards 33
2. Acute Toxicity Limits 34
3. Use Patterns 34
C. Data Gaps 34
D. Required Labeling 35
III. Product Chemistry 37
DISCIPLINARY REVIEW
Chemistry Profile 38
Data Gaps 38
Required Labeling 39
TOPICAL DISCUSSIONS
Chemical Identity 40
Manufacturing Process 41
Formation of Unintentional Ingredients 41
Ingredients in Pesticide Products 42
Product Analytical Methods and Data 42
Physical/Chemical Properties 42
B i bl i og r aphy 45
IV. 'Environmental Fate." 47
DISCIPLINARY REVIEW
Environmental Fate Profile 47
Data Gaps 47
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Page
V. Toxicology 49
DISCIPLINARY REVIEW
Toxicology Profile 49
Data Gaps 49
Required Labeling 50
TOPICAL DISCUSSIONS
Acute Effects 51
Local Irritation 52
Dermal Sensitization 53
Subchronic 21-Day Dermal 53
Subchronic Neurotoxicity 53
Teratology 53
Mutagenicity 54
VI. Residue Chemistry 57
VII. Ecological Effects 59
DISCIPLINARY REVIEW
Ecological Effects Profile 59
Data Gaps 59
Required Labeling 59
TOPICAL DISCUSSIONS
Microbes 60
Birds 60
Aquatic Invertebrates 61
Freshwater Fish 62
Bibliography 63
ASPON®
EMULSIFIABLE CONCENTRATE
I. Regulatory Position 65
A. Regulatory Decision 65
B. Criteria for Registration Under the
Standard 65
C. Acceptable Ranges and Limits 66
1. Product Composition Standards 66
2. Acute Toxicity Limits 67
3. Use Patterns and Application Methods 68
D. Data Gaps 69
E. Required Labeling 70
1. Product Chemistry 70
2. Human Hazard - Precautionary Labeling.... 71
3. Environmental Fate 73
4. Environmental Hazards 73
II. Regulatory Rationale 75
A. Regulatory Decision 75
B. Acceptable Ranges and Limits 75
1. Product Composition Standards 75
2. Acute Toxicity Limits 75
3. Use Patterns and Application Methods 77
C. Data Gaps 77
D. Required Labeling 78
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Page
III. Product Chemistry 81
DISCIPLINARY REVIEW
Chemistry Profile 81
Data Gaps 81
Required Labeling 82
TOPICAL DISCUSSIONS
Chemical Identity 82
Manufacturing Process 82
Formation of Unintentional Ingredients 83
Ingredients in Pesticide Products 83
Product Analytical Methods and Data 83
Physical/Chemical Properties 83
Bibliography 84
IV. Environmental Fate 85
DISCIPLINARY REVIEW
Environmental Fate Profile 85
Exposure Profile 85
Required Labeling 86
V. Toxicology 87
DISCIPLINARY REVIEW
Toxicology Profile 87
Toxicology Hazard Assessment 87
Data Gaps 88
Required Labeling 90
TOPICAL DISCUSSIONS
Acute Effects 92
Local Irritation 93
Bibliography 96
VI. Ecological Effects 97
DISCIPLINARY REVIEW
Ecological Effects Profile 97
Required Labeling 97
TOPICAL DISCUSSIONS
Terrestrial Plants 97
Aquatic Invertebrates 98
Freshwater Fish 98
Bibliography 99
GRANULAR ASPO
I. Regulatory Position 101
A. Regulatory Decision 101
B. Criteria for Registration Under the
Standard 101
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Page
C. Acceptable Ranges and Limits 102
1. Product Composition Standards 102
2. Acute Toxicity Limits 103
3. Use Patterns and Application Methods 104
D. Data Gaps 104
E. Required Labeling 106
1. Product Chemistry 106
2. Human Hazard - Precautionary Labeling.... 106
3. Environmental Fate 106
4. Environmental Hazards 107
II. Regulatory Rationale 109
A. Regulatory Decision 109
B. Acceptable Ranges and Limits 109
1. Product Composition Standards 109
2. Acute Toxicity Limits 109
3. Use Patterns and Application Methods Ill
C. Data Gaps Ill
D. Required Labeling 112
III. Product Chemistry 113
DISCIPLINARY REVIEW
Chemistry Profile 113
Data Gaps 113
Required Labeling 113
TOPICAL DISCUSSIONS
Chemical Identity 114
Manufacturing Process 114
Formation of Unintentional Ingredients 114
Ingredients in Pesticide Products 114
Product Analytical Methods and Data 115
Physical/Chemical Properties 115
IV. Environmental Fate 117
DISCIPLINARY REVIEW
Environmental Fate Profile 117
Exposure Profile 117
Required Labeling 117
V- Toxicology 119
DISCIPLINARY REVIEW
Toxicology Profile 119
Toxicology Hazard Assessment 119
Data Gaps 120
Required Labeling 122
TOPICAL DISCUSSIONS
Acute Effects 122
Local Irritation 124
Bibliography 127
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VI. Ecological Effects
DISCIPLINARY REVIEW
Ecological Effects Profile 129
Required Labeling 129
TOPICAL DISCUSSIONS
Terrestrial Plants 129
Freshwater Fish 130
Bibliography 131
BIBLIOGRAPHY 133
APPENDIX A - Toxicity Category Warning and
First Aid Statements 147
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Chapter 1
HOW TO REGISTER
UNDER A REGISTRATION STANDARD
Organization of the Standard
Purpose of the Standard
Requirement to Re-register Under the Standard
"Product Specific" Data and "Generic" Data
Data Compensation Requirements under FIFRA 3(c)(1)(D)
Obtaining Data to Fill "Data Gaps"; FIFRA 3(c)(2)(B)
Amendments to the Standard
Organization of the Standard
This first chapter explains the purpose of a Registration Standard and
summarizes the legal principles involved in registering or re-registering under
a Standard. The second chapter sets forth the requirements that must be met to
obtain or retain registration for products covered by this particular
Registration Standard. In the remaining chapters, the Agency reviews the
available data by scientific discipline, discusses the Agency's concerns with
the identified potential hazards, and logically develops the conditions and
requirements that would reduce those hazards to acceptable levels.
Purpose o: the Standard
Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) provides that "no person in any State may distribute, sell, offer for
sale, hold for sale, ship, deliver for shipment, or receive (and having so
received) deliver or offer to deliver, to any person any pesticide which is not
registered with the Administrator [of EPA]." To approve the registration of a
pesticide, the Administrator must find, pursuant to Section 3(c)(5) that:
"(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to be submitted comply with
the requirements of this Act;
(C) it will perform its intended function without unreasonable adverse
effects on the environment; and
(D) when used in accordance with widespread and commonly recognized
practice it will not generally cause unreasonable adverse effects on
the environment."
In making these findings, the Agency reviews a wide range of data which
registrants are required to submit, and assesses the risks and benefits
associated with the use of the proposed pesticide. But the established
approach to making these findings has been found to be defective on two counts:
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 product1 approach was often inefficient and sometimes resulted
in inconsistent or incomplete regulatory judgments.
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Second, over the years, as a result of inevitable and continuing advances
in scientific knowledge, methodology, and policy, the data base for many
pesticiaes 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) ana proposed new guidelines for hazard testing in 1978 (43 FR 29686, July
10, 1973 and 43 FR 37336, August 2, 1973), many products that had already been
registered for years were being sold and used without the same assurances of
human and environmental safety as was being required for new products. Because
of this inconsistency, Congress directed EPA to re-register all previously
registered products, so as to bring their registrations and their data bases
into compliance with current requirements [See FIFRA Section 3(g)l-
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 ana its current
uses, and sets forth the Agency's comprehensive position on the conditions and
requirements for registration of all existing and future products which contain
that active ingredient. These conditions and requirements, all of which must
be met to obtain or retain full registration or re-registration under Section
3(c)(5) of FIFRA, include the submission of needed scientific data which the
Agency does not now have, compliance with standards of toxicity, composition,
labeling, and packaging, and satisfaction of the data compensation provisions
of FIFRA Section 3(c)(1)(D).
The Standard will also serve as a tool for product classification. As part
of the registration of a pesticide product, EPA may classify each product for
"general use" or "restricted use" [FIFRA Section 3(d)]. A pesticide is
classified for "restricted use" when seme special regulatory restriction is
needed to ensure against unreasonable adverse effects to man or the
environment. Many such risks of unreasonable adverse effects can be lessened
if expressly-designed label precautions are strictly followed. Thus the
special regulatory restriction for a "restricted use" pesticide is usually a
requirement that it be applied only by, or under the supervision of, an
applicator who has been certified by the State or Federal government as being
competent to use pesticides 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 162.1 He), 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.
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Requirement _to Re-register Under the Standard
FIFHA Section 3(g), as amended in 1978, directs EPA to re-register all
currently registered products as expeditiously as possible. Congress also
agreed that re-registration should be accomplished by the use of Registration
Standards.
Each registrant of a currently registered product to which this Standard
applies, and who wishes to continue to sell or distribute his product in
commerce, must apply for re-regisration. His application must contain proposed
labeling that complies with this Standard.
EPA will issue a notice of intent to cancel the registration of any
currently registered product to which this Standard applies if the registrant
fails to comply with the procedures for re-registration set forth in the
Guidance Package which accompanies this Standard.
"Product Specific" Data and "Generic" Data
In the course of developing this Standard, EPA has determined the types of
data needed for evaluation of the properties and effects of products to which
the Standard applies, in the disciplinary areas of Product Chemistry,
Environmental Fate, Toxicology, Residue Chemistry, and Ecological Effects.
These determinations are based primarily on the data Guidelines proposed in
1978 (43 FR 29686, July 10, 1978, and 43 FR 37336, August 2, 1978), as applied
to the use patterns of the products to which this Standard applies. Where it
appeared that data from a normally applicable Guidelines requirement was
actually unnecessary to evaluate these products, the Standard indicates that
the requirement has been waived. On the other hand, in some cases studies not
required by the Guidelines may be needed because of the particular composition
or use pattern of products the Standard covers; if so, the Standard explains
the Agency's reasoning. Data guidelines have not yet been proposed for the
Residue Chemistry discipline, but the requirements for such data have been in
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 second chapter.)
The various kinds of data normally required for registration of a pesticide
product can be divided into two basic groups;
(A) data that is "product specific," i.e., data that relates only to
the properties or effects of a product with a particular composition
(or a group of products with closely similar composition); and
(B) "generic" data that pertains to the properties or effects of a
particular ingredient, and thus is relevant to an evaluation of the
risks and benefits of all products containing that ingredient (or all
such products having a certain use pattern), regardless of any such
product's unique composition.
The Agency requires certain "product specific" data for each product to
characterize the product's particular composition and physical/chemical
properties (Product Chemistry), and to characterize the product's acute
toxicity (which is a function of its total composition). The applicant for
registration or re-registration of any product, whether it is a manufacturing-
use or end-use product, and without regard to its intended use pattern, must
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submit or cite enough of this kind of data to allow EPA to evaluate the
product. For such purposes, "product specific" data on any product other than
the applicant's is irrelevant, unless the other product is closely similar in
composition to the applicant's. (Where it has been found practicable to group
similar products for purposes of evaluating, with a single set of tests, all
products in the group, the Standard so indicates.) "Product specific" data on
the efficacy of particular end-use products is also required where the exact
formulation may affect efficacy and where failure of efficacy could cause
public health problems.
All other data needed to evaluate pesticide products concerns the
properties or effects of a particular ingredient of products (normally a
pesticidally active ingredient, but in some cases a pesticidally inactive, or
"inert," ingredient). Some data in this "generic" category are required to
evaluate the properties and effects of all products containing that ingredient
[e.g., the acute LD-50 of the active ingredient in its technical or purer
grade; see proposed 40 CFR 163.81-1 (a), 43 FR 37355].
Other "generic" data are required to evaluate all products which both
contain a particular ingredient and are intended for certain uses (see, e.g.,
proposed 40 CFR 163.82-1, 43 FR 37363, which requires subchronic oral testing
of the active ingredient with respect to certain use patterns only). Where a
particular data requirement is use-pattern dependent, it will apply to each
end-use product which is to be labeled for that use pattern (except where such
end-use product is formulated from a registered manufacturing-use product
permitting such formulations) and to each manufacturing-use product with
labeling that allows it to be used to make 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)(1)(D)] or data generation [under Section 3(c)(2)(B)] for "generic" data
that is required only with respect to some use patterns, he may elect to delete
those use patterns from his labeling at the time he re-registers his product.
An applicant for registration of a new product under this Standard may
similarly request approval for only certain use patterns.
Data Compensation Requirements under FIFRA 3(c)(1)(D)
Under FIFRA Section 3(c)(1)(D), an applicant for registration, re-
registration, or amended registration must offer to pay compensation for
certain existing data the Agency has used in developing the Registration
Standard. The data for which compensation must be offered is all data which is
described by all the following criteria:
(1) the data were first submitted to EPA (or to its predecessor agencies,
USDA or FDA), on or after January 1, 1970;
(2) the data were submitted to EPA (or USDA or FDA) by some other
applicant or registrant in support of an application for an
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experimental use permit, an amendment adding a new use to a
registration, or for re-registration, or to support or maintain in
effect an existing registration;
(3) the data are relevant to the Agency's decision to register or re-
register the applicant's product under th,e Registration Standard,
taking into account the applicant's product's composition and intended
use pattern(s);
(4) the data are determined by EPA to be valid and usable in reaching
regulatory conclusions; and
(5) the data are not those 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 re-registration of an already registered product under
this Standard, or for registration of a new product under this Standard,
accordingly must determine which of the data used by EPA in developing the
Standard must be the subject of an offer to pay compensation, and oiust submit
with his application the appropriate statements evidencing his compliance with
FIFRA Section 3(c)(1)(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 determin-
ing whether the applicant's product is registrable. There may be cases, how-
ever, where because of close similarities between the composition of two or
more products, another firm's data may suffice to allow EPA to evaluate some or
all of the "product specific" aspects of the applicant's product. In such a
case, the applicant may choose to cite that data instead of submitting data
from tests on his own product, and if he chooses that option, he would have to
comply with the offer-to-pay requirements of Section 3(C)(1)(D) for that data.
Each applicant for registration or re-registration of a manufacturing-use
product, and each applicant for registration or re-registration of an end-use
product, who is not exempted by FIFRA Section 3(c)(2)(D), must comply with the
Section 3(c)(1)(D) requirements with respect to each item of "generic" data
that relates to his product's intended uses.
A detailed description of the procedures an applicant must follow in
applying for re-registration (or new registration) under this Standard is found
in the Guidance Package for this Standard.
Obtaining Data to Fill "Data Gaps"; FIFRA 3(c)(2)(B)
Some of the kinds of data EPA needs for its evaluation of the properties
and effects of products to which this Standard applies have never been
submitted to the Agency (or, if submitted, have been found to have deficiencies
rendering them inadequate for making registrability decisions) and 'nave 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".
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FIFRA Section 3(c)(2)(B), added to FIFRA by the Congress in 1978,
autnorizes 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 its summary second chapter, the "generic" data gaps
and notes the classes of products to which these data gaps pertain. The
Standard also points out that to be registrable under the Standard, a product
must be supported by certain required "product spe::fic" 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 re-registering currently registered products, EPA
will issue Section 3(c)(2)(B) directives requiring the registrants to take
appropriate steps to fill all identified data gaps — whether that data in
question is "product specific" or "generic" — in accordance with a schedule.
Persons who wish to obtain registrations for new products under this
Standard will be required to submit (or cite) sufficient "product specific"
data before their applications are approved. Upon registration, they will be
required under Section 3(c)(2)(B) to take appropriate steps to submit data
needed to fill "generic" data gaps. (We expect they will respond to this
requirement by entering into cost-sharing agreements with other registrants who
previously have been told they must furnish the data.) The Guidance Package
for this Standard details the steps that must be taken by registrants to comply
with .Section 3(c)(2)(B).
Amendments to the Standard
Applications for registration which propose uses or formulations that are
not presently covered by the Standard, or which present product compositions,
product chemistry data, hazard data, toxicity levels, or labeling that do not
meet the requirements of the Standard, will automatically be considered by the
Agency to be requests for amendments to the Standard. In response to such
applications, the Agency may request additional data to support the proposed
amendment to the Standard, or may deny the application for registration on the
grounds that the proposed product would cause unreasonable adverse effects to
the environment. In the former case, when additional data have been
satisfactorily supplied, and providing that the data do not indicate the
potential for unreasonable adverse effects, the Agency will then amend the
Standard to cover the new registration.
Each Registration Standard is based upon all data and information available
to the Agency's reviewers on a particular date prior to the publication date.
Tnis "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 SPA in Washington, D.C., or copies of which may be requested from
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the Agency. When all the present "data gaps" have been filled and the
submitted data have been reviewed, the Agency will revise the Registration
Standard. Thereafter, when the Agency determines that the internally
maintained addenda have significantly altered the conditions for registration
under the Standard, the document will be updated and re-issued for publication.
While the Registration Standard discusses only the uses and hazards of
products containing the designated active ingredient(s), the Agency is also
concerned with the potential hazards of some inert ingredients and impurities.
Independent of the development of any one Standard, the Agency has initiated
the evaluation of some inert pesticide ingredients. Where the Agency has
identified inert ingredients of concern in a specific product to which the
Standard applies, these ingredients will be pointed out in the Guidance Package.
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REGULATORY POSITION
This chapter presents the Agency's decision on what
Standards of product composition, toxicity, use, labeling,
and packaging are required for the pesticide active ingredient
in question. The decision complies with the rules and
regulations (40 CFR 162) used to implement the Federal
Insecticide, Fungicide, and Rodenticide Act, as amended
(FIFRA), and with the Agency's present regulatory policies.
There are different requirements for manufacturing-use
chemicals and for each type of end-use formulation which
present a significantly different set of hazards. This
Registration Standard is based upon all data and information
on Aspon^* available to the Agency's reviewers as of February 27,
1979.
Companies which have submitted data in support of
their registrations of Aspon® products are Chevron Chemical
Company and Stauffer Chemical Company, both of Richmond,
Calif., and O.M. Scott & Sons of Marysville, Ohio. These
data may be cited by other registrants or applicants for
registration, when appropriate, to support the registration(s)
of their own product(s), provided they have offered and
* Aspon^ is a registered trade name of Stauffer Chemical
Company. Its use in this document does not constitute
endorsement or recommendation for use by this Agency. Since
there is no acceptable common name for this compound, the
trade name will be used in this document for convenience.
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agreed to pay compensation, as required by FIFRA Sections
3(c) (1) (d). and 3(c) (2) (d) .
Manufacturing-Use Aspon™
The Agency has reviewed all data available to
it. Although incomplete, these data indicate that
manufacturing-use Aspon™ (which includes both the
technical material and the granular formulation interme-
diate) is suitable for registration because it does
not meet or exceed the risk criteria leading to a
Rebuttable Presumption Against Registration [Chapter 40,
Section 162.11(a) of the Code of Federal Regulations],
Data gaps have been identified; when these data are
supplied, the Agency will again review the registration
status of this compound.
In order to be covered under this Standard, a manufactur-
ing-use Aspon® product must comply with the following
standards. A manufacturing-use Aspon™ product must contain
Aspon™ (0,0,0,0-Tetrapropyl dithiopyrophosphate) as an
active ingredient. Given current manufacturing-use product
grades and formulation methods, the Agency expects that most
technical material will range above 90% a.i. and that most
granular formulation intermediates will range above 25% a.i.
Should an applicant desire to register a manufacturing-use
product that departs greatly from those currently registered,
that applicant should contact the Agency for specific
directions on how to accomplish registration. Because
Aspon^ is corrosive to steel, manufacturers of the technical
material may not ship it in unlined steel containers. The
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acute toxicology testing on a manufacturing-use Aspon0'
product must demonstrate into which Toxicity Category (I
through IV) the product falls for the following acute
effects:
Acute Oral Toxicity;
Acute Dermal Toxicity;
Acute Inhalation Toxicity;
Primary Eye Irritation; and
Primary Dermal Irritation.
Labels for currently registered manufacturing-use
(ft
Asporf£y products must include the following:
1. The intended end-use of products formulated from
manufacturing-use products determines which data applicants
for (re)registration of the manufacturing-use product are
(ft
required to submit or cite. All manufacturing-use Aspon**
products must therefore carry one of the following statements
on the label:
a. For Formulation Into End-Use Insecticide Products
Intended Only for Domestic, Non-Food, Outdoor Use;
b. For Formulation Into End-Use Insecticide Products
Intended Only for Non-Domestic, Non-Food, Outdoor Use;
or
c. For Formulation Into End-Use Insecticide Products
Intended Only for Domestic or Non-Domestic, Non-Food,
Outdoor Use.
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2. All manufacturing-use Aspon° products must carry
the following warning on the label, under the "Hazards
to Wildlife" section:
This pesticide is toxic to fish. Do not discharge
into lakes, streams, ponds, or public water unless
in accordance with NPDES permit. For guidance, contact
your Regional Office of the EPA.
3. All technical Aspon™ products must carry the
following warning on the label:
This product is corrosive to steel. Do not transport
or store in unlined steel containers.
4. Manufacturing-use product labels must comply with
the requirements of 40 CFR 162.10 regarding label format,
including placement of hazard warnings on the label, type
size and color, etc.
To be covered under this Standard, all applicants for
registration or re-registration of technical and formulation
intermediate products must agree to cite or submit the
following information on the composition and toxicity of
each proposed product. After each data gap is listed the
section in the Proposed Guidelines which describes that type
of data and when it is required [43 FR, No. 132, 29696 of
July 10, 1978; and 43 FR, No. 163, 37336 of August 22,
1978]. While the Agency does have some limited data on the
product chemistry of Aspon^, possible changes in the
manufacturing processes or product formulation methods may
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affect the product's physical/ chemical characteristics.
All normally required data on physical/chemical characteristics
are therefore being listed as data gaps, so that the Agency
can obtain the most current data.
Guidelines Section
Product Chemistry
For Both Technical and Formulation
Intermediate
1) Product Identity 163.61-3(a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits. 163.61-6(a)
6) Certification of Limits 163.61-6(b)
7) Analytical Methods 163.61-7(a)
8) Analytical Results 163.61-7 (b) (1)
For Technical
9) Color 163.61-8(c) (1)
10) Odor 163.61-8(c) (2)
11) Melting Point 163.61-8 (c) (3)
12) Solubility (in quantitative
terms) 163. 61-8 (c) (4)
13) Stability 163.61-8 (c) (5)
14) Octanol/Water Partition
Coefficient 163.61-8 (c) (6)
15) Physical State 163.61-8 (c) (7)
16) Density or Specific Gravity 163.61-8(c) (8)
17) Boiling Point 163.61-8 (c) (9)
18) Vapor Pressure 163.61-8 (c) (10)
19) pH 163.61-8(c) (11)
For Formulation Intermediate
20) Density or Specific Gravity 163.61-8 (c) (8)
21) Storage Stability 163.61-8 (c) (12)
22) Flammability 163.61-8 (c) (13)
23) Oxidizing or Reducing Action 163.61-8 (c) (14)
24) Explosiveness 163.61-8 (c) (15)
25) Corrosion Characteristics 163.61-8 (c) (18)
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Guidelines Section
*Toxicology
1) Acute Oral Toxicity Study 163.81-1
2) Acute Dermal Toxicity Study 163.81-2
3) Acute Inhalation Toxicity Study... 163.81-3
4) Primary Eye Irritation Study 163.81-4(c)
OR
Data on pH of the Product 163.81-4 (b)
5) Primary Dermal Irritation Study... 163.81-5
6) Dermal Sensitization Study 163.81-6
To be covered under this Standard, applicants for
registration or re-registration of technical and formulation
intermediate products which are labeled for formulation into
products intended for non-domestic or domestic, outdoor,
non-food, use must agree to submit or cite all of the
information required above, as well as the following informa-
tion:
Non-Domestic or Domestic Use
Guidelines Section
Environmental Fate
1) Hydrolysis 163.62-7(b)
2) Photolysis (in water) 163.62-7(c)
3) Aerobic Soil Metabolism 163.62-8(b)
4) Microbial Metabolism 163.62-8 ( f) (2)
5) Activated Sludge Metabolism 163.62-8 (g)
6) Leaching 163.62-9(b)
7) Adsorption/Desorption 163.62-9(d)
8) Field Dissipation study on
representative emulsifiable con-
centrate and granular formula-
tions 163.62-10'
9) Fish Accumulation 163.62-ll(d)
Toxicology
1) Teratogenicity Study 163.83-3
2) Acute Delayed Neurotoxicity 163.81-7
"*A demonstration that a manufacturing-use
product has a composition substantially similar to a
manufacturing-use product for which the Agency already
has acceptable acute toxicity data will satisfy acute
toxicity data requirements for the former product. Both
active and inert ingredients will be considered in making
determinations of similarity.
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Guidelines Section
Ecological Effects
1) Microbial Metabolism 163. 62-8 ( f) (3)
2) The avian acute oral LD-50 for
one species of waterfowl (pref-
erably the mallard) ££ one species
of upland game bird (preferably
the bobwhite, other native quail,
or the ring-necked pheasant) 163.71-1
3) A 48-hour LC-50 (or EC-50) for
one species of aquatic inverte-
brate (preferably Daphnia magna).. 163.72-2
Rmulsif iable Concentrate
In order to be covered under this Standard, an end-use
emulsif iable concentrate (EC) Aspon™ product must contain
(ft
Aspon0* (0,0,0, 0-Tetrapropyl dithiopyrophosphate) as an
active ingredient. FIFRA Section 162.11(c) lists the
criteria for classifying pesticides for restricted, non-
domestic, or domestic use.
(»
EC Aspon0* products which are shown to have a Toxicity
Category I rating for any of the following acute effects
must be classified for restricted use (i.e., for retail sale
to and application only by certified applicators or persons
under their direct supervision) :
Acute Oral Toxicity;
Acute Dermal Toxicity; or
Acute Inhalation Toxicity.
EC Aspon^ products which are shown to have a Toxicity
Category II rating for any of the following acute effects
must be classified for non-domestic use:
Acute Oral Toxicity;
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Acute Dermal Toxicity; or
Acute Inhalation Toxicity.
(6)
EC Aspon"^ products which are shown to have any of the
following Toxicity Category ratings may be classified for
domestic use:
Acute Oral Toxicity: Category III or IV
Acute Dermal Toxicity: Category III or IV
Acute Inhalation Toxicity: Category III or IV
Primary Eye Irritation: Category I through IV
Primary Dermal Irritation: Category I through IV
EC products intended for domestic use with Toxicity Category
I or II ratings for primary eye or dermal irritation must
meet the criteria for child-resistant packaging [see FR
44(48):13019-13024, March 9, 1979].
Labels for currently registered EC Aspon^ products
must include the following:
1. If EC Aspon® products contain petroleum distillates,
the statement "Contains petroleum distillates" must appear
on the label in close proximity to the ingredient statement.
Active ingredient:
0,0,0,0-Tetrapropyl dithiopyrophosphate %
Inert Ingredients* %
Total 100%
*Contains Petroleum Distillates
2. If the EC Aspon0' product has an Acute Oral Toxicity
Category IV and contains greater than 10% by weig-ht petroleum
distillates, the following first aid statement must appear
on the label (see also Table 2, Appendix A):
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If_ swallowed; If the patient is unconscious, main-
tain breathing and heart rate (CPRrcardiopulmonary
resuscitation). Contact your local Poison Control
Center, physician, or hospital immediately- Do Not
Induce Vomiting!
If the EC Aspon® product has an Acute Oral Toxicity
Category I and contains greater than 10% by weight petroleum
distillates, the following first aid statement must appear
on the label (see also Table 2, Appendix A):
^_f swallowed; If the patient is unconscious, main-
tain breathing and heart rate (CPR:cardiopulmonary
resuscitation). Contact your local Poison Control
Center, physician, or hospital immediately. If the
patient is conscious, induce vomiting (syrup of ipecac;
if not available, stimulate the back of the throat
with finger). Never give anything by mouth to an
unconscious person!
If the EC Aspon™ product has an Acute Oral Toxicity
Category II or III and contains greater than 10% by weight
petroleum distillates, the following first aid statement
must appear on the label (see also Table 2, Appendix A):
If swallowed; If the patient is unconscious, main-
tain breathing and heart rate (CPR:cardiopulmonary
resuscitation). Contact your local Poison Control
Center, physician, or hospital immediately.
-17
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The question of whether vomiting should or should
not be induced will be determined on a case-by-case basis
based on a review of the toxicity of active ingredients,
inert ingredients, and impurities.
3. All EC Aspon® products must carry the following
warning on the label:
Keep children and pets off treated areas for 48 hours
after application and until the grass has completely
d r i ed.
4. All EC Aspon^ products must carry the following
warning on the label, under the "Hazards to Wildlife"
section:
This pesticide is toxic .to fish. Do not contaminate
water by cleaning of equipment or disposal of wastes.
5. All currently registered EC Aspon™ products
between 12% and 28% a.i. must carry on the label the acute
toxicity hazard warnings and first aid statements required
for the following Toxicity Categories (see Appendix A):
Acute Dermal Toxicity - III
Primary Eye Irritation - I
Primary Dermal irritation - II
6. EC product labels must comply with the requirements
of 40 CFR 162.10 regarding label format, including placement
of hazard warnings on the label, type size and color, etc.
In addition, all labels and labeling intended for agricultural
uses must bear the statement, "This product must be applied
in accordance with 40 CFR 170." (Registrants may amplify
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this statement on labels or labeling by stating the require-
ments of 40 CFR Part 170 or additions thereto if they
choose.)
To be covered under this Standard, all applicants for
registration or reregistration of EC Aspon™ products must
agree to submit or cite the following information on the
composition of each proposed product. After each data gap
is listed the section in the proposed Guidelines which
describes that type of data and when it is required [43 FR,
No. 132, 29696 of July 10, 1978; and 43 FR, No. 163, 37336
of August 22, 1978].
Guidelines Section
Product Chemistry
1) Product Identity 163.61-3(a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process. 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits 163.61-6(a)
6) Certification of Limits 163.61-6(b)
7) Analytical Methods 163.61-7(a)
8) Analytical Results 163.61-7 (b) (1)
9) Color 163.61-8(c) (1)
10) Odor 163.61-8(c) (2)
11) Density or Specific Gravity 163.61-8(c) (8)
12) Storage Stability 163.61-8 (c) (12)
13) Flammability 163.61-8 (c) (13)
14) Oxidizing or Reducing Action 163.61-8(c)(14)
15) Explosiveness 163.61-8 (c) (15)
16) Miscibility 163.61-8 (c) (16)
17) Viscosity 163.61-8 (c) (17)
18) Corrosion Characteristics 163.61-8 (c) (18)
19) Dielectric Breakdown Voltage 163.61-8 (c) (19)
Listed below are the Toxicology data which must be
submitted or cited to obtain registration or re-registration
for EC Aspon™ products. After each data gap is listed the
Section in the Proposed Guidelines of August 22, 1978 (43
FR, No. 163, 37336) which describes that type of data and
when it is required. The Agency has determined that currently
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registered EC products between 12% and 28% a.i. are substan-
tially similar in composition, and that EC products between
65% and 68% a.i. are substantially similar in composition.
Acute toxicity data available on any one product in either
group may be cited in support of the registration of any
other product in that group, provided compensation has been
offered for use of these data. Currently registered EC
Aspon^ products which contain other active ingredients
must be tested individually for each acute effect.
Guidelines Section
ECs Between 12% and 28% a.i.*
1) Acute oral toxicity (rat)
on product in upper range
(i.e., @ 25% a.i.) 163.81-1
2) Acute inhalation (rat)
on product in upper range
(i.e., 0 25% a.i.) 163.81-3
ECs Between 65% and 68% a.i.*
1) Acute oral toxicity (rat) 163.81-1
2) Acute dermal toxicity
(rabbit) 163.81-2
3) Acute inhalation (rat) 163.81-3
4) Primary eye irritation
(rabbit) 163.81-4 (c)
OR
Data on pH of the Product.... 163.81-4(b)
5) Primary skin irritation
(rabbit) 163.81-5
(ft
ECs With Asjponv and Other Active Ingredients
1) Acute oral toxicity (rat).... 163.81-1
2) Acute dermal toxicity
(rabbit) 163.81-2
3) Acute inhalation (rat) 163.81-3
* A demonstration that an EC Aspon0' product has a composi-
tion substantially similar to an EC product for which the
Agency already has acceptable acute toxicity data will
satisfy acute toxicity data requirements for the former
product. Both active and inert ingredients will be considered
in making determinations of similarity.
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Guidelines Section
4) Primary eye irritation
(rabbit) 163.81-4 (c)
OR
Data on pH of the Product.... 163.81-4 (b)
5) Primary skin irritation
(rabbit) 163.81-5
Granular Aspon^
In order to be covered under this Standard, an end-use
granular Aspon® product must contain Aspon® (0,0,0,0-
Tetrapropyl dithiopyrophosphate) as an active ingredient.
FIFRA Section 162.11 (c) lists the criteria for classifying
pesticides for restricted, non-domestic, or domestic use.
Granular Aspon™ products which are shown to have a
Toxicity Category I rating for any of the following acute
effects must be classified for restricted use (i.e., for
retail sale to and application only by certified applicators
or persons under their direct supervision):
Acute Oral Toxicity;
Acute Dermal Toxicity; or
Acute Inhalation Toxicity.
Granular Aspon® products which are shown to have a
Toxicity Category II rating for any of the following acute
effects must be classified for non-domestic use:
Acute Oral Toxicity;
Acute Dermal Toxicity; or
Acute Inhalation Toxicity.
Granular Aspon® products which are shown to have any
of the following toxicity Category ratings may be classified
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for domestic use:
Acute Oral Toxicity: Category III or IV
Acute Dermal Toxicity: Category III or IV
Acute Inhalation Toxicity: Category III or IV
Primary Eye Irritation: Category I through IV
Primary Dermal Irritation: Category I through IV
Granular products intended for domestic use with Toxicity
Category I or II ratings for primary eye or dermal irritation
must meet the criteria for child-resistant packaging [see PR
44(48):13019-13024, March 9, 1979].
Labels for currently registered granular Aspon^
products must include the following:
1. All granular Aspon^ products must carry the
following warning on the label:
Keep children and pets off treated areas for 48 hours
after application and until the grass has completely
d r i ed .
(8)
2. All granular Aspon** products must carry the
following warning on the label, under the "Hazards to
Wildlife" section:
This pesticide is toxic to fish. Do not contaminate
water by cleaning of equipment or disposal of wastes.
(ft
3. All currently registered granular Aspon0^ products
between 1% and fi% a.i. must carry on the label the acute
toxicity hazard warnings and first aid statements required
for the following Toxicity Categories (see Appendix A).
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Without Fertilizer
1) Acute Oral Toxicity - III
2) Acute Dermal Toxicity - III
3) Primary Eye Irritation - III
4) Primary Dermal Irritation - III
With Fertilizer
1) Acute Oral Toxicity - III
2) Acute Dermal Toxicity - III
3) Primary Eye Irritation - II
4) Primary Dermal Irritation - III
4. Granular product labels must comply with the require-
ments of 40 CFR 162.10 regarding label format, including
placement of hazard warnings on the label, type size and
color, etc. In addition, all labels and labeling intended
for agricultural use must bear the following statement,
"This product must be applied in accordance with 40 CFR
170." (Registrants may amplify this statement on labels or
labeling by stating the requirements or 40 CFR Part 170 or
additions thereto if they choose.)
To be covered under this Standard, all applicants
for registration or reregistration of granular Aspon®
products must agree to submit or cite the following informa-
tion on the composition of each proposed product. After
each data gap is listed the section in the Proposed Guidelines
which describes that type of data and when it is required
[43 FR, No. 132, 29696 of July 10, 1978; and 43 FR, No. 163,
37336 of August 22, 1978].
Guidelines Section
Product Chemistry
1) Product Identity 163.61-3(a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits 163.61-6(a)
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[Footnote concluded from previous page.]
** An acute inhalation toxicity study is required for
granular products if "20 percent or more of the aerodynamic
equivalent of the formulated product (as registered or under
conditions of use) is composed of particulates not larger
than 10 microns in diameter" [Guidelines Section
1*3.81-3(a) (2)(ii)] . An acute inhalation test on any
currently registered granular product between 1% and 6% a.i.
may be submitted or cited in support of the registrations of
all currently registered granular products. A request for
a waiver of this requirement based on percent of particulates
not larger than 10 microns must be made individually
for each product.
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ASPON®
MANUFACTURING-USE
(TECHNICAL AND FORMULATION INTERMEDIATE)
I. Regulatory Position
A. Regulatory Decision
The Agency has reviewed all data available to it.
Although incomplete, these data indicate that manufacturing-
use Aspon® is suitable for registration because it does
not meet or exceed the risk criteria leading to a Rebuttable
Presumption Against Registration [Chapter 40, Section
152.11(a) of the Code of Federal Regulations], Data gaps
have been identified; when these data are supplied, the
Agency will again review the registration status of this
compound.
(ft
The Agency has determined that manufacturing-use Aspon**
does not appear to cause an unreasonable adverse effect
with proper label directions and precautions. Those manufac-
turing-use products currently registered may be reregistered
subject to the conditions imposed for data requirements, and
new products may also be registered under the terms of this
Standard.
B. Criteria for Registration Under the Standard
To be registered under this Standard, manufacturing-use
products must meet the following conditions:
1. The manufacturing-use product contains Aspon® as
an active ingredient;
2. The manufacturing-use product bears required labeling;
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3. The manufacturing-use product must list on the label
the intended end-use(s) of formulated products produced
from the manufacturing-use product; and
4. The applicant for registration of manufacturing-
use products complies with all other terms and conditions
specified in this Standard and hereby offers and agrees
to pay compensation to other persons, with regard to the
approval of this application, to the extent required by
3(c)(l)(d) and 3(c)(2)(d) of the Federal Insecticide,
Fungicide, and Rodenticide Act [FIFRA], as amended, 7
U.S.C. 136(c) (1) (d) and 136 (c) (2) (d) .
C. Acceptable Ranges and Limits
1. Product Composition Standards
To be covered under this Standard, all technical and
formulation intermediate products must contain Aspon^
ro,0,0,0-Tetrapropyl dithiopyrophosphate] as an active
ingredient. The Agency will consider for registration
manufacturing-use products which contain any percentage of
active ingredient. In addition, currently registered and
proposed manufacturing-use products must agree to submit or
cite the information on product composition identified as
data gaps in Section I.D of this document.
Standards have not yet been set for contaminants and
inerts in manufacturing-use Aspon® products. When standards
are set for any contaminants or inerts in manufacturing-use
Aspon^ products, manufacturing-use products must comply
with those standards.
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2. Acute Toxicity Limits
The Agency will grant registration to manufacturing-use
Aspon® products which have Toxicity Category I through IV
ratings for any of the following acute effects:
1) Acute Oral Toxicity;
2) Acute Dermal Toxicity;
3) Acute Inhalation Toxicity;
4) Primary Eye Irritation; and
5) Primary Dermal Irritation.
3. Use Patterns
To be covered under this Standard, manufacturing-use
(i.e., technical and formulation intermediate) products must
carry label directions permitting further formulation into
end-use pesticides which are intended only for outdoor,
non-food, domestic or non-domestic use. Directions for
formulation into products intended for other end-uses must
be supported by appropriate data and a petition to amend the
Standard to permit the extended uses.
D. Data Gaps
To be covered under this Standard, applicants for
registration or re-registration of technical and formulation
intermediate products must agree to cite or submit the
following information on the composition and toxicity of
each proposed product. After each data gap is listed the
section in the Proposed Guidelines which describes that type
of data and when it is required [43 FR, No. 132, 29696 of
July 10, 1978; and 43 FR, No. 163, 37336 of August 22,
1978].
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Guidelines Section
Product Chemistry
For Both Technical and Formulation
Intermediate
1) Product Identity 163.61-3(a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits 163.61-6(a)
6) Certification of Limits 163.61-6(b)
7) Analytical Methods 163.61-7(a)
8) Analytical Results 163.61-7(b) (1)
For Technical
9) Color 163.61-8(c) (1)
10) Odor 163.61-8(c) (2)
11) Melting Point 163.61-8 (c) (3)
12) Solubility (in quantitative
terms) 163. 61-8 (c) (4)
13) Stability 163.61-8 (c) (5)
14) Octanol/Water Partition
Coefficient 163.61-8 (c) (6)
15) Physical State 163.61-8 (c) (7)
16) Density or Specific Gravity 163.61-8(c) (8)
17) Boiling Point 163.61-8 (c) (9)
18) Vapor Pressure 163.61-8 (c) (10)
19) pH 163.61-8(c) (11)
For Formulation Intermediate
20) Density or Specific Gravity 163.61-8 (c) (8)
21) Storage Stability 163.61-8 (c) (12)
22) Flammability 163.61-8 (c) (13)
23) Oxidizing or Reducing Action 163.61-8 (c) (14)
24) Explosiveness 163.61-8 (c) (15)
25) Corrosion Characteristics L63.61-8(c)(18)
*Toxicology
1) Acute Oral Toxicity Study 163.81-1
2) Acute Dermal Toxicity Study 163.81-2
3) Acute Inhalation Toxicity Study... 163.81-3
4) Primary Eye Irritation Study 163.81-4(c)
OR
Data on pH of the Product 163.81-4(b)
5) Primary Dermal Irritation Study... 163.81-5
6) Dermal Sensitization Study 163.81-6
* A demonstration that a manufacturing-use Aspon**
product has a composition substantially similar to a
manufacturing-use product for which the Agency already
has acceptable acute toxicity data will satisfy acute
toxicity data requirements for the former product. Both
active and inert ingredients will be considered in making
determinations of similarity.
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To be covered under this Standard, applicants for
registration or re-registration of technical and formulation
intermediate products which are labeled for formulation into
products intended for outdoor, non-food, non-domestic or
domestic uses must agree to submit or cite all of the
information required above, as well as the following informa-
tion:
Non-Domestic or Domestic Use
Guidelines Section
Environmental Fate
1) Hydrolysis 163.62-7(b)
?.) Photolysis (in water) 163.62-7(c)
3) Aerobic Soil Metabolism 163.62-8(b)
4) Microbial Metabolism 163.62-8( f) (2)
5) Activated Sludge Metabolism 163.62-8(g)
6) Leaching 163.62-9(b)
7) Adsorption/Desorption 163.62-9(d)
8) Field Dissipation study on
representative emulsifiable con-
centrate and granular formula-
tions 163.62-10
9) Fish Accumulation 163.62-ll(d)
Toxicology
1) Teratogenicity Study 163.83-3
2) Acute Delayed Neurotoxicity 163.81-7
Ecological Effects
1) Microbial Metabolism 163.62-8 (f) (3)
2) The avian acute oral LD-50 for
one species of waterfowl (pref-
erably the mallard) o_r one species
of upland game bird (preferably
the bobwhite, other native quail,
or the ring-necked pheasant) 163.71-1
3) A 48-hour LC-50 (or EC-50) for
one species of aquatic inverte-
brate (preferably Daphnia magna).. 163.72-2
R. Required Labeling
1. Product Chemistry
The ingredient statement will list the active ingredient
as: 0,0,0,0-Tetrapropyl dithiopyrophosphate. In all cases,
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the percentage by weight of active ingredient and inerts
must equal 100%.
Active Ingredient:
0,0,0,0,-Tetrapropyl dithiopyrophosphate %
Inert Ingredients %
Total 100%
?. Human Hazard - Precautionary Labeling
The hazard warnings and first aid statements on all
manufacturing-use product labels must correspond to the
^oxidty Category assigned to that product for each acute
effect. Tables 1 and 2 in Appendix A list the required
labeling for each acute Toxicity Category (for more detailed
information, see 40 CFR 162.10 on labeling requirements).
3. Environmental Hazards
All manufacturing-use product labels must include the
following warning:
"This pesticide is toxic to fish. Do not discharge
into lakes, streams, ponds, or public water unless
in accordance with NPDES permit. For guidance, contact
your Regional Office of the EPA."
4. Physical or Chemical Hazards
Manufacturers of the technical chemical may not ship it
to formulators in unlined steel containers. In addition,
the technical label should include the following warning,
for the information of formulators who use the technical
product to manufacture end-use products:
"This product is corrosive to steel. Do not transport
or store in unlined steel containers."
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5. Use Patterns
All manufacturing-use Aspon™ products must list on the
label the intended end-use(s) of formulated products produced
from the manufacturing-use products. All manufacturing-use
Aspon^ product labels must contain one of the following
statements:
1. "For Formulation Into End-use Insecticide Products,
Intended Only For Domestic, Non-food, Outdoor Use";
or
2. "For Formulation Into End-use Insecticide Products,
Intended Only For Non-domestic, Non-food, Outdoor Use";
or
3. "For Formulation Into End-use Insecticide Products,
Intended Only For Domestic or Non-domestic, Non-food,
Outdoor Use."
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II. Regulatory Rationale
A. Regulatory Decision
The Agency has determined that the technical and formula-
(R>
tion intermediate Aspoa0^ products described in this
Standard can be registered as manufacturing-use pesticides
for sale, distribution, and reformulation in the United
States. There are no data currently available which suggest
(Ok
that Asporf0' meets any of the risk criteria for unreasonable
adverse effects, as listed in 40 CFR 162.11(a). In addition,
to be covered under this Standard, applicants must agree to
submit or cite the data listed in Section I.D of this
document.
R. Acceptable Ranges and Limits
1. Product Composition Standards
The Agency will consider for registration manufacturing-
use products which contain any percentage of Aspon™ as
an active ingredient. Nevertheless, given current manufac-
turing-use product grades and formulation methods, the
Agency expects that most technical material will range
above 90% a.i. and that granular formulation intermediates
will range above 25% a.i. Should an applicant desire to
register a manufacturing-use product that departs greatly
from those currently registered, that applicant should
contact the Agency for specific directions on how to
accomplish regi-stration.
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2. Acute Toxicity Limits
The Agency will register manufacturing-use Aspon®
products which have Toxicity Category I through IV ratings
because the use pattern does not result in possible exposure
to the general public, and because the pesticide industry
can be required to provide safe working conditions (i.e.,
specialized protective clothing such as respirators) which
will mitigate possible hazards from products with high
toxicity ratings.
3. Use Patterns
Manufacturing-use pesticides may be used only in the
formulation of specific end-use products, because [under
the Proposed Guidelines, 163.40-2(c) and (d)] manufactur-
ing-use pesticides are not intended for pesticidal applica-
tion as registered.
C. Data Gaps
The data which applicants are required to submit or
cite in order to obtain (re)registration for manufacturing-use
Aspon^ are listed in Section I.D of this document.
A field dissipation study on representative emulsifiable
concentrate and granular products is required for all
manufacturing-use products because they are labeled for
formulation into end-use Aspon® products intended for
terrestrial use. A teratology study is required for
manufacturing-use products labeled for formulation into
domestic or non-domestic end-use products because the use
-34-
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pattern could result in exposure to pregnant women. Other
chronic studies, such as oncogenicity, are not currently
required because the use pattern is not expected to result
in repeated exposure to humans over a significant portion of
the human life-span.
D. Required Labeling
Acute toxicity hazard warnings must accurately reflect
the product's level of toxicity (products may not be labeled
to show either greater or lesser hazard from the product
than in fact exists). Because the currently registered 90%
a.i. technical product has been determined to be corrosive
to steel, technical manufacturers may not ship the technical
to formulators in unlined steel containers; in addition, the
current label must be modified to include a warning against
transportation or storage in unlined steel containers (see
Section I.E).
-35-
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III. Product Chemistry
FIFRA 3(c)(2)(A) requires the Agency to establish
guidelines for registering pesticides in the United States.
The Agency requires registrants to provide quantitative data
on all added ingredients, active and inert, which are
equal to or greater than 0.1% of the product by weight.
To establish the composition of products proposed
for registration, the Agency requires data and informa-'
tion not only on the manufacturing and formulation pro-
cesses, but also a discussion on the formation of manu-
facturing impurities and other product ingredients, inten-
tional and unintentional. Further, to assure that the
composition of the product as marketed will not vary
from the composition evaluated at the time of registra-
tion, applicants are required to submit a statement certify-
ing the upper and lower composition limits for the added
ingredients, or upper limits only for some unintentional
ingredients. Subpart D suggests specific precision limits
for ingredients based on the percentage of ingredient
and the standard deviation of the analytic method.
In addition to the data on product composition, the
Agency also requires data to establish the physical and
chemical properties of both the pesticide active ingredient
and its formulations. For example, data are needed concerning
the identity and physical state of the active ingredient
(e.g., melting'and boiling point data, vapor pressure
-37-
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and solubility). Data are also required on the properties
of the formulated product to establish labeling cautions
(e.g., flammability, corrosivity or storage stability). The
Agency use.s these data to characterize each pesticide and to
determine its environmental and health hazards.
DISCIPLINARY REVIEW
Chemistry Profile
Data Gaps
Required Labeling
Chemistry.Profile
"Aspon^" is a trade name for Of0,0,0-Tetrapropyl
dithiopyrophosphate. The technical material is a straw-to-
dark amber liquid with a moderately aromatic odor. It is
stable at room temperature, miscible with most organic
solvents, and compatible with commonly-used pest control
materials. It is corrosive to steel.
Data Gaps
Listed below are Product Chemistry data needed to
obtain registration or reregistration for all manufacturing-
use Aspon® products. After each data gap is listed the
section in the Proposed Guidelines (July 10, 1978, 43 FR,
No. 132, 2969*5) which describes that type of data and when
it is required.
Guidelines Section
For Both Technical and Formulation
Intermediate
1) Product Identity 163.61-3 (a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits 163.61-6(a)
6) Certification of Limits 163.61-6(b)
7) Analytical Methods 163.61-7(a)
8) Analytical Results 163.61-7 (b) (1)
-38-
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For Technical
9T~Color 163. 61-8 (c) (1)
10) Odor 163.61-8(c) (2)
11) Melting Point 163.61-8 (c) (3)
12) Solubility (in quantitative
terms) 163. 61-8 (c) (4)
13) Stability 163. 61-8 (c) (5)
14) Octanol/Water Partition
Coefficient 163. 61-8 (c) (6)
15) Physical State 163.61-8 (c) (7)
16) Density or Specific Gravity 163.61-8 (c) (8)
17) Boiling Point 163. 61-8 (c) (9)
18) Vapor Pressure 163. 61-8 (c) (10)
19) pH • 163.61-8(c) (11)
20) Flammability 163. 61-8 (c) (13)
21) Explosiveness 163. 61-8 (c) (15)
22) Viscosity 163. 61-8 (c) (17)
23) Corrosion Characteristics 163.61-8(c) (18)
For Formulation Intermediate
24) Density or Specific Gravity 163.61-8 (c) (8)
25) Storage Stability 163. 61-8 (c) (12)
26) Flammability 163. 61-8 (c) (13)
27) Oxidizing or Reducing Action 163.61-8 (c) (14)
28) Explosiveness 163. 61-8 (c) (15)
29) Corrosion Characteristics 163.61-8 (c) (18)
Required Labeling
Ingredient Statement: The ingredient statement will
list the active ingredient as 0,0,0,0-Tetrapropyl dithiopyro-
phosphate.
Physical Hazard Precautionary Labeling; Since the
technical product is corrosive to steel, technical manufac-
turers may not ship it to formulators in unlined steel
containers, and the technical label must carry the following
warning:
"This product is corrosive to steel. Do not transport
or store in steel containers."
-39-
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TOPICAL DISCUSSIONS
Corresponding to each of the Topical Discussions
listed below is the number of the section in the 'Pro-
posed Guidelines for Registering Pesticides' of July
10, 1978 (43 FR, No. 132, 29696), which explains the minimum
Product Chemistry data needed in order to obtain registration
or reregistration for manufacturing-use Aspon^ products.
Guidelines Section
Chemical Identity ........................ 163.61-3
Manufacturing Processes .................. 163.61-4
Formation of Unintentional Ingredients... 163.61-5
Ingredients in Pesticide Products ........ 163.61-6
Product Analytical Methods and Data ...... 163.61-7
Physical/Chemical Properties ............. 163.61-8
Chemical Identity
At present, there is no acceptable common name for
the insecticide, 0,0,0,0-Tetrapropyl dithiopyrophosphate.
C.H-0. 5 S
•5 ' ^ n n
?P-0-
OC3H7
Other names, as listed on Chemline (March 1980) are as
follow:
Thiopyrophosphoric acid [ ( (HO) 2PS) 20] , tetra-
propyl ester (SCI)
Thiodiphosphoric acid [ ( (HO) 2P (S) ) 20] , tetra-
propyl ester (9CI)
NPD
Tetra-n-propyl dithionopyrophosphate
Tetra-n-propyl dithiopyrophosphate
Propyl thiopyrophosphate [ ( (PrO) 2P (S) )20]
-40-
-------
Other structural identifiers are:
CAS Registry No. 3244-90-4
MF C12H28°5P2S2
Mol. Wt. 378.43
Manufacturing Process
Although details of the present manufacturing process
are not available, the published literature (Sittig, 1971,
MRDI GS0019-002; Sittig, 1977, MRID GS0019-003) , as well as
the applicable U.S. patent No. 2,663,722 (1953, MRID GS0019-
006) indicate the following reactions occur:
(1) 1 S I S S
1C H 0^^ " f c-Pi°\ " " J^-pi
21 J ^>P-C1| + H,0 + 2CcH,.N - > J ">P-0-P 2C5H5N + H2° "*" C°2 + 2NaC1
The manufacturing processes are not sufficiently detailed
to satisfy Proposed Guidelines requirements and may not even
be relevant unless the manufacturer actually uses them.
Formation of Unintentional Ingredients
There is no information available to the Agency on the
formation of unintentional ingredients during the manufacture
of Aspon"' products.
-41-
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Ingredients in Pesticide Products
For all Aspon^ products, the Agency requires a
listing of the upper and lower limits established (by
the producer or formulator) for each active ingredient,
and the upper limit for each impurity, reaction product,
and degradation product which is known to be present or
which might reasonably be identified.
(a) manufacturing-use preparation: the only
currently registered technical product contains a
minimum of 90.00% active ingredient (a.i.).
(b) formulation intermediate: the only currently
registered formulation intermediate (25-G) contains
25.00% a.i.
Product Analytical Methods and Data
Stauffer (1970, MRDI GS0019-005) and Ja et al. (1966,
MRID GS0019-001) identify two methods, infrared (IR) and
thin-layer chromatographic (TLC)-colorimetric, for the
analysis of technical Aspon™. The IR method is included
in the EPA manual of chemical methods for pesticides (EPA,
1976, MRID GS0019-015). (The high-resolution nuclear
magnetic resonance (NMR) spectra of analytical-grade
Aspon®, as a structural identification aid and reference
source, is available from the literature [Keith et al.,
1968, MRID 005004395]).
Physical/Chemical Properties
Color; The technical material is a straw-to-dark amber
color (Stauffer, 1968, MRID GS0019-004).
-42-
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Odor; The technical material has a moderately aromatic
odor (Stauffer, 1968, MRID GS0019-004).
Melting Point; The melting point of the technical
material is below -40°F (given as the freezing point)
[Stauffer, 1968, MRID GS0019-004].
Solubility; The solubility of the technical material is
0.16% in water at room temperature (Stauffer, 1968, MRID
GS0019-004) and soluble with difficulty in light petroleum
(Martin and Worthing, 1977, MRID GS0019-017). It is completely
miscible with all common organic solvents (Stauffer, 1968,
MRID GS0019-004).
Stability; The technical material is stable with
insignificant hydrolysis in water at room temperature and
stable for at least 24 hours at 100°C (Stauffer, 1968,
MRID GS0019-004); it is compatible with commonly-used pest
control materials (Spencer, 1973, MRID GS0019-018).
Octanol/Water Partition Coefficient; No data are
available on the technical material.
Physical State; The technical material is in liquid
form. The formulation intermediate is in granular form.
Density or Specific Gravity; The technical material's
specific gravity is 1.119 to 1.123 at 68/68°F [Stauffer,
1968, MRin GS0019-004]. No data are available on the
formulation intermediate.
Boiling Point; The boiling point for the technical
material is 104 C at 0.01 mm Hg (Martin and Worthing,
-43-
-------
197*7, MRID GS0019-017) and 148°C at 2 mm Hg (Spencer, 1973,
MRID GS0019-018).
Vapor Pressure; No data are available on the technical
product.
pH; No data are available on the technical product.
Storage Stability; No data are available on the formula-
tion intermediate.
Flammability; The technical material's flash point
[open cup] is 300°F [Stauffer, 1968, MRID GS0019-004] . No
data are available on the formulation intermediate.
Oxidizing or Reducing Action; No data are avail-
able on the formulation intermediate.
Explosiveness; The technical material decomposes
[without explosive hazard] at 300°F [Stauffer, 1968, MRID
GS0019-004]. No data are available on the formulation
intermediate.
Viscosity; The technical material's viscosity is 12.5
cp at 70°F [Stauffer, 1968, MRID GS0019-004].
Corrosion Characteristics; The technical material may
cause discoloration and physical changes on prolonged
contact with metal; it is corrosive to steel (Martin and
Worthing, 1977, MRID GS0019-017). No data are available on
the formulation intermediate.
-44-
-------
BIBLIOGRAPHY
MRID
GS0019-015
GS0019-001
005004395
rs0019-017
005001354
005002074
GS 0019-002
GS0019-003
GS0019-018
GS 0019-004
GS0019-005
005004479
GS0019-006
CITATION
Chemline, Chemical Information on Line [Data base].
Bethesda, Md: National Library of Medicine.
March 1980.
EPA. 1976. EPA manual of chemical methods for
pesticides and devices. AOAC, Arlington, Virginia.
Ja, W.; Smith W.J.; Below, J.F. 1966. The analysis
of technical Aspon, Richmond Report No. RR-66-35.
Stauffer Chemical Co., New York, N.Y.
Keith, L.H.; Garrison, A.W.; Alford, A.L. 1968. The
high resolution NMR spectra of pesticides. I.
organophosphorus pesticides. J. Assoc. Off. Anal.
Chem. 51(5):1063-1094.
Martin, H.; Worthing, C.R., eds. 1977. Pesticide
index: basic information on the chemicals used
as active components of pesticides. 5th ed.
British Crop Protection Council, Worcestershire,
England.
McMahon, B.; Burke, J.A. 1978. Analytical behavior data
for chemicals determined using AOAC multiresidue
methodology for pesticide residues in foods. J. Assoc.
Off. Anal. Chem. 61:640-652.
Ruzicka, J.H.; Thomson, J.; Wheals, B.B.; Wood, N.F.
1968. The application of gel chromatography to the
separation of pesticides. Part I. Organophosphorus
pesticides. J. Chromatog. 34(l):14-20.
Sittig, M. 1971. Agricultural chemicals manufacture.
Noyes Data Corp., Park Ridge, N.J.
Sittig, M. 1977. Pesticides process encyclopedia.
Noyes Data Corp., Park Ridge, N.J.
Spencer, E.Y. 1973. Guide to the chemicals used in
crop protection. 6th ed. Canada Dept. of Agri-
culture, Ontario, Canada.
Stauffer Chemical Co. 1968. Aspon insecticide,
technical information bulletin. New York, N.Y.
Stauffer Chemical Co. 1970. Infrared procedure to
determine the assay of Aspon, method no. MPO 25-3.
(Unpublished). New York, N.Y.
Toy, A.D.F. 1951. Tetraethyl dithionopyrophosphate
and related tetraalkyl dithionopyrophosphates.
J. Am. Chem. Soc. 73:4670-4674.
U.S. Patent No. 2,663,722. 1953. Method of preparing
tetraalkyl dithionopyrophosphates.
-45-
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IV. Environmental Fate
DISCIPLINARY REVIEW
Environmental Fate Profile
Data Gaps
Environmental Fate Profile
There are no data currently available on the environ-
(R>
mental fate of Aspoa0'.
Data Gaps
Listed below are the Environmental Fate data needed to
obtain registration or re-registration for manufacturing-use
Aspon® products. After each data gap is listed the
section in the Proposed Guidelines of July 10, 1978 (43 FR,
Mo. 132 29696) which describes that type of data and when it
is required.
Guidelines Section
1) Hydrolysis 163.62-7(b)
2) Photolysis (in water) 163.62-7(c)
3) Aerobic Soil Metabolism 163.62-8(b)
4) Microbial Metabolism 163.62-8 ( f) (2)
5) Activated Sludge Metabolism 163.62-8(g)
6) Leaching 163.62-9(b)
7) Adsorption/Desorption 163.62-9(d)
8) Field Dissipation study on
representative emulsifiable con-
centrate and granular formula-
tions 163.62-10
9) Fish Accumulation 163.62-ll(d)
-47-
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v. Toxicology
DISCIPLINARY REVIEW
Toxicology Profile
Data Gaps
Required Labeling
Toxicology Profile
No data are available on technical or formulation
-------
Applicants for registration or re-registration of
technical and formulation intermediate products which are
formulated into products intended for outdoor, non-food,
non-domestic or domestic use must also agree to submit or
cite the following information:
Non-Domestic ££ Domestic Use
Guidelines Section
1) Teratogenicity Study 163.83-3
2) Acute Delayed Neurotoxicity 163.81-7
Required Labeling
Product-specific acute toxicity precautionary labeling
is required. Acceptable categories of acute toxicity,
and the corresponding required precautionary labeling
statements, appear in Appendix A to this document.
TOPICAL DISCUSSIONS
Corresponding to each of the Topical Discussions
listed below is the number of the section in the 'Proposed
Guidelines' of August 22, 1978 (43 FR, No. 163, 37336) which
explains the minimum Toxicology data needed in order to
obtain registration or reregistration for manufacturing-use
Aspon^ products.
Guidelines Sections
Acute Effects 163.81-1, -2, -3, and -7
Local irritation 163.81-4 and -5
Sens itizat ion 163.81-6
Subchronic 21-Day Dermal 163.82-2
Subchronic Neurotoxicity 163.82-5
Teratology 163.83-3
Mutagenicity 163.84-1 thru -4
-50-
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Acute Effects
Acute Oral Toxicity
The minimum data requirement for testing acute oral
toxicity (LD-50) is one test on each technical and
formulation intermediate product, preferably using the
laboratory rat. No data are available for assessing the
acute oral LD-50 toxicity of either the technical or the
formulation intermediate chemicals.
Acute Dermal Toxicity
The minimum data requirement for testing acute
dermal toxicity (LD-50) is one test, preferably using
the albino rabbit, for each technical and formulation
intermediate product. This test should be conducted on
both intact and abraded skin. No data are available for
assessing the acute dermal LD-50 of either the technical
or the formulation intermediate chemicals.
Acute Inhalation Toxicity
The minimum data requirement for testing acute
inhalation toxicity (LC-50) is one test for each technical
and formulation intermediate product, preferably using
the laboratory rat. No data are available for assessing
the acute inhalation LC-50 of either the technical or
the formulation intermediate chemicals.
Acute Delayed Neurotoxicity
Data are required on the technical material if the
active ingredient, or any of its metabolites, degradation
-51-
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products, or impurities, cause esterase depression or
are structurally related to a substance that induces
delayed neurotoxicity-
Aspon^ is an organophosphate. Organophosphorus
pesticides must be tested for acute delayed neurotoxicity.
The preferred species for testing is the female domestic
chicken (hen).
No data are available for assessing the acute
delayed neurotoxicity of the technical chemical.
Local Irritation
Primary Eye Irritation
The minimum data requirement for testing primary
eye irritation is one test for each technical and
formulation intermediate product, conducted on a mammal,
preferably the albino rabbit. Data which demonstrate
that the test substance has a pH of 1-3 or 12-14 should
be submitted instead of data from a primary eye irritation
test. For all regulatory purposes, the Agency will
assume that substances with the above pH values or which
cause Category I skin effects are corrosive (i.e., have
a Toxicity Category I rating). No data are available
for assessing the primary eye irritation potential of
either the technical or formulation intermediate chemicals,
Primary Dermal Irritation
The minimum data requirement for testing primary
dermal irritation is one test for each technical and
-52-
-------
formulation intermediate product, conducted on a mammal,
preferably the albino rabbit. No data are available for
assessing the primary dermal irritation potential of
either the technical or the formulation intermediate
chemicals.
Dermal Sensitization
The minimum data requirement for dermal sensitization
is an intradermal test on all manufacturing-use products,
preferably using the albino guinea pig. These data are
required if repeated human skin contact, under the conditions
of use, is expected. No data are available for assessing
the dermal sensitization of the technical or formulation
intermediate chemicals.
Subchronic 21-Day Dermal
This testing may be required on the technical material,
depending on data to be submitted on the persistence of
/C7\ ft<\
Aspon" as applied under use directions for end-use Aspon0'
products.
Subchronic Neurotoxicity
This testing may be required on the technical material,
depending on results of the acute delayed neurotoxicity
studies required in this chapter.
Teratology
The minimum data requirement for teratology is a test on
the technical material in two mammalian species. This test
is required to support the registration of manufacturing-use
-53-
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products when their pesticidal end-use may reasonably be
expected to result in significant exposure to human females.
No data are available for assessing the teratology of the
technical product.
Mutagenicity
The following studies represent only the minimum require-
(ft
ments for data on the potential heritable effects of Aspon**:
1. A mammalian in vitro point mutation test;
2. A sensitive sub-mammalian point mutation test (bacteria,
fungi, insect);
3. A primary DNA damage test (i.e., sister chromatid
exchange or unscheduled DNA 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 therein (FR 43, No.
163, Tuesday, August 22, 1978). 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.
-54-
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These 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.
No data are available for assessing the mutagenicity of
the technical product, but testing may be required when the
Agency's Guidelines on mutagenicity testing are completed.
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VI. Residue Chemistry
(6)
Use of Asporr* is not likely to result directly
in residues in human food and animal feed items because
it has not been registered for use on food or feed crops,
There are no residue data requirements for non-food uses
of Aspon®.
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VT I. Ecological Effects
DISCIPLINARY REVIEW
Ecological Effects Profile
Data Gaps
Required Labeling
Ecological Effects Profile
From the available studies, it is apparent that the
technical material is very highly toxic to aquatic organisms,
particularly fish. The technical was shown to be practically
non-toxic to birds in dietary tests.
Data Gaps
Listed below are the Ecological Effects data which must
be submitted or cited to obtain registration or re-registra-
a\
tion for manufacturing-use Aspon" products. After each
data gap is listed the section in the Proposed Guidelines of
July 10, 1978 (43 FR, No. 132, 29696) which describes that
type of data and when it is required.
Guidelines Section
1) Microbial Metabolism 163.62-8 (f) (3)
2) The avian acute oral LD-50 for
one species of waterfowl (pref-
erably the mallard) p_r one species
of upland game bird (preferably
the bobwhite, other native quail,
or the ring-necked pheasant) 163.71-1
3) A 48-hour LC-50 (or EC-50) for
one species of aquatic inverte-
brate (preferably Daphnia magna).. 163.72-2
Required Labeling
All technical and formulation intermediate products intended
for shipment must bear the warning: "This pesticide is
toxic to fish. Do not discharge into lakes, streams, ponds,
or public water unless in accordance with NPDES permit. For
guidance, contact your Regional Office of the EPA."
-59-
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TOPICAL DISCUSSIONS
Corresponding to each of the Topical Discussions
listed below is the number of the section in the 'Pro-
posed Guidelines for Registering Pesticides' of July
10, 1978 (43 PR, No. 132, 29696), which explains the minimum
Ecological Effects data needed in order to obtain registration
(ft
or reregistration for manufacturing-use Aspon^ products.
Guidelines Sections
Microbes 163.62-8 (f) (3)
Birds 163.71-1 and .71-2
Aquatic Invertebrates 163.72-2
Fish 163.72-1
Microbes
Data on the effects of pesticides on microbes are
required to support the registration of manufacturing-
use products labeled for formulation into end-use products
intended for terrestrial, noncrop uses. There are no
microbial data available on Aspon^.
Birds
A determination of the single-dose, oral LD50 for
one bird species is required to support the registration
of every manufacturing-use product. There are no avian
LD_ data available on Aspon^.
A determination of the avian subacute dietary LC 0
(5-day dietary exposure) is required to support the registra-
tion of all manufacturing-use products. Acceptable data are
(ft
available on the effects of Aspon0^ in the diet of several
species [see Table 3]. These data indicate that Aspon® is
-60-
-------
practically non-toxic, subacutely, to upland game birds and
wild waterfowl.
(ft
Table 3. Subacute Dietary Toxicity of Aspon^ to Birds
Species
Mallard
duck
Bobwhite
quail
Ring-necked
pheasant
Mallard
duck
Japanese
quail
Formulation
93%
Technical
93%
Technical
95%
Technical
95%
Technical
95%
Technical
LC-50
(ppm)
4353
8414
>5000
>5000
>5000
Reference
Joiner, 1975,
MRID 000004830
Fink and Reno,
1976, MRID
000004831
Hill et al. ,
1975, MRID
GS0019-010
MRID GS0019-01
MRID GS0019-01
0
0
A decision to require chronic toxicity data (reproductive
or simulated and actual field tests), however, will depend
upon the results of studies on persistence, degradation
rates, and accumulation.
Aquatic Invertebrates
A determination of the 48-hour EC.... or LC.-,,
50 50
for an aquatic invertebrate species is required to support
the registration of all manufacturing-use products. There
-^_ ..~ ~w._~ v,v.*J.-^J.». „„ „-£-"" .
The decision to require life-cycle or other tests on
aquatic invertebrates will depend upon the results of
studies on persistence, degradation rates, and accumulation.
-61-
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Freshwater Fish
The minimum data required for establishing the acute
toxicity of Aspon*^ in fish is a determination of the
96-hour LC p both for one coldwater fish species (preferably
rainbow trout) and for one warmwater fish species (preferably
bluegill). Acceptable data are available on the acute
toxicity of Aspon™ to fish in several EPA tests which
studied its effects on coldwater as well as warmwater fish.
Based on these findings, which are summarized in Table 4,
Aspon^ can be considered to be very highly toxic to
coldwater and warmwater fish species.
Table 4. Acute Toxicity of Technical Aspon® to Fresh-
water Fish
Species
Formulation
LC-50
(ppm)
Reference
Rainbow Trout
Rainbow Trout
Bluegill
90% (Tech.) 0.07
93% (Tech.) 0.1
90% (Tech.) 0.1
EPAf 1975,
MRID GS0019-
007
EPA, 1976,
MRID GS0019-
008
EPA, 1976,
MRID GS0019-
009
Due to the highly toxic nature of Aspon^ with respect
to coldwater and warmwater fish, further testing (i.e.,
embryo-larvae and life-cycle tests [Proposed Guidelines
Section 163.72-4]) will depend upon the results of studies
on persistence, degradation rates, and accumulation.
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BIBLIOGRAPHY
MRID CITATION!
GS0019-007 EPA. 1975. Report on the toxicity of technical
Aspon to rainbow trout. (U.S. EPA, Chemical and
Biological Investigations Branch, Beltsville,
Maryland, Static jar test No. 913, unpublished report.)
GS0019-008 EPA. 1976. Report on the toxicity of Aspon technical
to rainbow trout. (U.S. EPA, Chemical and Biological
Investigations Branch, Beltsville, Maryland, Static
jar test No. 932, unpublished.)
GS0019-009 EPA. 1976. Report on the toxicity of Aspon Technical
to bluegill sunfish. (U.S. EPA, Chemical and Biologi-
cal Investigations Branch, Beltsville, Maryland, Static
jar test No. 998, 7/14/76, unpublished report.)
000004831 Fink, R.; Reno, F.E. 1976. Final report: eight-day
dietary LC-50 — bobwhite quail: project no. 132-129.
(Unpublished study received March 8, 1976 under 476-
2163; prepared by Hazleton Laboratories America, Inc.
in cooperation with Maryland Dept. of Agriculture, Div.
of Inspection and Regulation, submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:225231-A).
GS0019-010 Hill, E.F.; Heath, R.G.; Spann, J.W.; Williams, J.D.
1975. Lethal dietary toxicities of environmental
pollutants to birds. Special Scientific Report—
Wildlife No. 191. U.S. Fish and Wildlife Service,
Washington, D.C.
000004830 Joiner, R.L. 1975. Safety evaluation of Aspon Technical
by a five-day feeding test in mallard ducks: T-5397.
(Unpublished study received June 26, 1975 under 476-
2163; submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL: 223289-A) .
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EMULSIFIABLE CONCENTRATE ASPON®
I. Regulatory Position
A. Regulatory Decision
The Agency has reviewed all data available to it.
Although incomplete, these data indicate that emulsifiable
concentrate (EC) Aspon® is suitable for registration
because it does not meet or exceed the risk criteria leading
to a Rebuttable Presumption Against Registration [Chapter
40, Section Ifi2.11(a) of the Code of Federal Regulations].
Data gaps have been identified; when these data are supplied,
the Agency will again review the registration status of this
compound.
(R)
The Agency has determined that EC Aspon0^ does not
appear to cause an unreasonable adverse effect with proper
label directions and precautions. Those EC products currently
registered may be reregistered subject to the conditions
imposed for data requirements, and new products may also be
registered under the terms of this Standard.
B. Criteria for Registration Under the Standard
To be registered under this Standard, EC formulations of
must meet the following conditions:
1. The EC product contains Aspon® as an active
ingredient [if an unregistered source of Aspon® is
used in formulating, then the data outlined under
Section 162.18-2(c) (d) (1) (iii) will be required];
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2. The EC Aspon^ product is within the acute toxicity
limits for restricted or general use and bears the
required labeling;
3. The EC Aspon® product is within acceptable
ranges for use patterns and application methods;
and
4. The applicant for registration of EC products
complies with all other terms and conditions specified
in this Standard and hereby offers and agrees to pay
compensation to other persons, with regard to the
approval of this application, to the extent required by
3(c)(l)(d) and 3(c)(2)(d) of the Federal Insecticide,
Fungicide, and Rodenticide Act [FIFRA], as amended, 7
(I.S.C. 13fi(c)(l)(d) and 136(c) (2) (d) .
C. Acceptable Ranges and Limits
1. Product Composition Standards
To be covered under this Standard, all EC products must
contain Aspon^ [0,0,0,0-Tetrapropyl dithiopyrophosphate]
as an active ingredient. The Agency will consider for
registration EC products which contain any percentage of
active ingredient. In addition, currently registered and
proposed EC products must agree to submit or cite the
information on product composition identified as data
gaps in Section I.D of this document.
Standards have not yet been set for contaminants and
(ft
inerts in EC Aspon** products. When standards are set for
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any contaminants or inerts in EC Aspon° products, EC
end-use products must comply with those standards.
2. Acute Toxicity Limits
a. Restricted Use
The Agency will grant registration to EC Aspon^
products as restricted pesticides (i.e., for retail sale to
and application only by Certified Applicators or persons
under their direct supervision) for non-food, outdoor use
which have a Toxicity Category I rating for any of the
following acute effects:
1) Acute Oral Toxicity;
2) Acute Dermal Toxicity;
3) Acute Inhalation Toxicity;
4) Primary Eye Irritation; and
5) Primary Dermal Irritation.
b. Non-Domestic Use
The Agency will grant registration to EC Aspon™
products intended for non-domestic, non-food, outdoor use
which have a Toxicity Category II rating for any of the
following acute effects:
1) Acute Oral Toxicity;
2) Acute Dermal Toxicity; or
3) Acute Inhalation Toxicity;
(ft
The Agency will grant registration to EC Asponcy products
intended for non-domestic, non-food, outdoor use which
have a Toxicity Category I or II rating for either of
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the following acute effects:
1) Primary Eye Irritation; and
2) Primary Dermal Irritation.
c. Domestic Use
The Agency will grant registration to EC Aspon®
products intended for domestic, non-foodf outdoor use which
have a Toxicity Category III or IV rating for any of the
following acute effects:
1) Acute Oral Toxicity;
2) Acute Dermal Toxicity;
3) Acute Inhalation Toxicity;
The Agency will grant registration to EC Aspon^ products
intended for domestic, non-food, outdoor use which have
a Toxicity Category I through IV rating for either of
the following acute effects:
1) Primary Eye Irritation; and
2) Primary Dermal Irritation.
3. Use Patterns and Application Methods
To be covered this Standard, EC products may be used
only as an insecticide on home lawns or ornamental turf.
Application may not be made aerially or by air blast methods,
Currently registered EC products must retain present
recommendations for dosage rates on the labels. Applicants
who wish to increase the dosage recommendations on currently
registered products, or who wish to register new products
with higher dosage recommendations than those currently
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registered, may be required to submit additional supporting
data.
D. Data Gaps
To be covered under this Standard, applicants for
registration or reregistration of EC Aspon® products must
agree to submit or cite the following information on the
composition and toxicity of each proposed product. After
each data gap is listed the section in the Proposed Guidelines
which describes that type of data and when it is required
[43 PR, No. 132, 29696 of July 10, 1978; and 43 FR, No. 163,
37336 of August 22, 1978].
Guidelines Section
Product Chemistry
1) Product Identity 163.61-3(a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits 163.61-6(a)
6) Certification of Limits 163.61-6(b)
7) Analytical Methods 163.61-7(a)
8) Analytical Results 163.61-7 (b) (1)
9) Color 163.61-8(c) (1)
10) Odor 163.61-8(c) (2)
11) Density or Specific Gravity 163 .61-8(c) (8)
12) Storage Stability 163.61-8 (c) (12)
13) Flammability 163.61-8 (c) (13)
14) Oxidizing or Reducing Action 163.61-8 (c) (14)
15) Explosiveness 163.61-8 (c) (15)
16) Miscibility 163.61-8 (c) (16)
17) Viscosity 163.61-8 (c) (17)
18) Corrosion Characteristics 163.61-8 (c) (18)
19) Dielectric Breakdown Voltage 163.61-8(c) (19)
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Guidelines Section
*Toxicology
ECs Between 12% and 2ft% a. i.
1) Acute oral toxicity (rat)
on product in upper range
(i.e., P 25% a.i.) 163.81-1
2) Acute inhalation (rat)
on product in upper range
(i.e., P 25% a.i.) 153.81-3
ECs Between 65% and 68% a.i.
1) Acute oral toxicity (rat).... 163.81-1
2) Acute dermal toxicity
(rabbit) 163.81-2
3) Acute inhalation (rat) 163.81-3
4) Primary eye irritation
(rabbit) 163.81-4 (c)
OR
Data on pH of the Product.... 163.81-4 (b)
5) Primary skin irritation
(rabbit) 163.81-5
ECs With Aspon^ and Other Active Ingredients
1) Acute oral toxicity (rat).... 163.81-1
2) Acute dermal toxicity
(rabbit) 163.81-2
3) Acute inhalation (rat) 163.81-3
4) Primary eye irritation
(rabbit) 163.81-4 (c)
OR
Data on pH of the Product.... 163.81-4(b)
5) Primary skin irritation
(rabbit) 163.81-5
E. Required Labeling
1. Product Chemistry
The ingredient statement will list the active ingredient
as: 0,0,0,0-Tetrapropyl dithiopyrophosphate. In all cases,
the percentages by weight of active ingredient and inerts
must equal 100%.
* A demonstration that an EC Asponty product has a composi-
tion substantially similar to an EC product for which the
Agency already has acceptable acute toxicity data will
satisfy acute toxicity data requirements for the former
product. Both active and inert ingredients will be considered
in making determinations of similarity.
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Active Ingredient:
0,0,Of0-Tetrapropyl dithiopyrophosphate %
Inert Ingredients %
Total 100%
If EC products contain petroleum distillates, the statement
"Contains petroleum distillates" must appear on the label in
close proximity to the ingredient statement.
Active Ingredient:
0,0,0,0-Tetrapropyl dithiopyrophosphate %
Inert Ingredients* %
Total 100%
* Contains Petroleum Distillates
2. Human Hazard - Precautionary Labeling
The hazard warnings and first aid statements on all
EC product labels must correspond to the Toxicity Category
assigned to that product for each acute effect (see Appendix
A). Specifically, all currently registered ECs between 12%
and 28% a.i. must carry on the label the acute tbxicity
hazard warnings and first aid statements required for the
following Toxicity Categories:
1) Acute Dermal Toxicity - III
2) Primary Eye Irritation - I
3) Primary Dermal Irritation - II
/R\
If the EC Aspon^ product has an Acute Oral Toxicity
Category IV and contains greater than 10% petroleum distillates,
the following first aid statement must appear on the label
(see also Table 2, Appendix A):
If swallowed; If the patient is unconscious, main-
tain breathing and heart rate (CPR:cardiopulmonary
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resuscitation). Contact your local Poison Control
Center, physician, or hospital immediately. Do Not
Induce Vomiting!
(O\
If the EC Aspon4* product has an Acute Oral Toxicity
Category I and contains greater than 10% petroleum distillates,
the following first aid statement must appear on the label
(see also Table 2, Appendix A):
If swallowed; If the patient is unconscious, main-
tain breathing and heart rate (CPRrcardiopulmonary
resuscitation). Contact your local Poison Control
Center, physician, or hospital immediately. If the
patient is conscious, induce vomiting (syrup of ipecac;
if not available, stimulate the back of the throat
with finger). Never give anything by mouth to an
unconscious person!
If the EC Aspon*^ product has an Acute Oral Toxicity
Category II or III and contains greater than 10% petroleum
distillates, the following first aid statement must appear
on the label (see also Table 2, Appendix A):
I_f swallowed; If the patient is unconscious, main-
tain breathing and heart rate (CPRrcardiopulmonary
resuscitation). Contact your local Poison Control
Center, physician, or hospital immediately.
The question of whether vomiting should or should
not be induced will be determined on a case-by-case basis
based on a review of the toxicity of active ingredients,
inert ingredients, and impurities.
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3. Environmental Fate
Because the use pattern clearly indicates the possibility
of post-application exposure to children and pets, the
following warning must appear on all EC labels: "Keep
children and pets off treated areas for 48 hours after
application and until the grass has completely dried."
Other environmental precautions not in conflict with specific
parts of this Standard should be retained.
4. Environmental Hazards
All EC products must bear the label warning: "This
pesticide is toxic to fish. Do not contaminate water
by cleaning of equipment or disposal of wastes*"
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II. Regulatory Rationale
A. Regulatory Decision
/«
The Agency has determined that the EC Aspon4* products
described in this Standard can be registered for sale,
distribution, and use in the United States. There are no
data currently available to the Agency which suggest that
Aspon^ meets any of the risk criteria for unreasonable
adverse effects, as listed in 40 CFR 162.11(a). In addition,
to be covered under this Standard, applicants must agree to
submit or cite the data listed in Section I.D of this
document, and must also meet the standards for use as listed
in Section I.e.2 of this document.
B. Acceptable Ranges and Limits
1. Product Composition Standards
The Agency will consider for registration EC products
which contain any percentage of Aspon® as an active
ingredient as long as the products meet the acute toxicity
standards listed in Section I.e.2 for domestic, non-domestic,
or restricted use. The Agency considers that the use
restrictions and required protective clothing for the
several acute toxicity levels will adequately protect humans
and the environment from unreasonable adverse effects.
2. Acute Toxicity Limits
a. Restricted Use
(ft
The Agency will register EC Asponcy products for
restricted, non-food, outdoor use which have a Toxicity
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Category I rating because certified applicators can legiti-
mately be expected to provide the specialized protective
clothing (for themselves or those under their supervision)
which are required for products with a Toxicity Category I
«
rating.
b. Non-Domestic Use
The Agency will register EC Aspon® products for
non-domestic, non-food, outdoor use which have a Toxicity
Category II rating for acute oral, dermal, or inhalation
toxicity, or which have a Toxicity Category I or II rating
for primary eye or dermal irritation because non-domestic
users can legitimately be expected to provide the specialized
protective clothing (for themselves or their employees)
which are required for products with these Toxicity Category
ratings. The Agency considers that these restrictions,
together with use of the required protective clothing, will
adequately protect humans from unreasonable adverse effects.
c. Domestic Use
/a
The Agency will register EC Aspori0' products for
domestic, non-food, outdoor use which have a Toxicity
Category III or IV rating for acute oral, dermal, or inhala-
tion toxicity, or which have a Toxicity Category I through
IV rating for primary eye or dermal irritation. EC products
intended for domestic use with Toxicity Category I or II
ratings for primary eye or dermal irritation must meet the
criteria for child resistant packaging [see FR 44 (48) :13019-
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13024, March 9, 1979]. The Agency considers that the
economic and aesthetic benefits from Aspon® use outweigh
the risks from products with acute Toxicity Category ratings
of III or IVf and that the use of child-resistant packaging
for products with Toxicity Category I or II ratings for
primary eye or dermal irritation will adequately protect
humans from unreasonable adverse effects.
3. Use Patterns and Application Methods
(ft
EC Aspon0' products may be registered for use as an
insecticide only on lawns and ornamental turf. EC products
may not be used on food crops because the hazard of such
uses and of residue ingestion has not been evaluated nor has
such an evaluation been requested. Application may not be
made aerially or by air blast methods because these two
methods can reasonably be expected to result in high exposures
to applicators, other persons, or wildlife close to the
application site. Currently registered EC products must
retain the dosage recommendations on the labels, in the
absence of data to support higher rates.
C. Data Gaps
The data on the physical/chemical composition and acute
toxicity which applicants are required to submit or cite for
EC Aspon^ products are listed in Section I.D of this
document. These data are required in order to obtain
registration for any proposed end-use product.
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D. Required Labeling
Acute toxicity hazard warnings must accurately reflect
the product's level of toxicity (products may not be labeled
to show either greater or lesser hazard from the product
than in fact exists). Proper emergency medical treatment of
patients who have ingested petroleum distillates is a
controversial subject. Two significant risks must be weighted
in reaching a decision on whether or not to induce emesis
[vomiting] or perform gastric lavage. If vomiting is
induced, or gastric lavage is performed, petroleum distillates
may be aspirated, possibly resulting in a fatal chemical
pneumonitis. However, retaining a highly toxic pesticide in
the stomach even for a short period of time may also prove
fatal. In reaching a decision on appropriate labeling policy
for products, the Agency considers the toxic properties of
active ingredients, inerts, and impurities; the Agency also
considers that emergency treatment may not be readily
available and that first aid will usually be administered by
a member of the family or general public who has little or
no medical training. In general, therefore, the Agency
believes that the best advice is to seek medical help
immediately and to keep the patient breathing until medical
help is available. The following first aid statement must
therefore appear on all labels of EC Aspon^ products which
contain greater than 10% by weight petroleum distillates:
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1. If patient is unconscious, maintain breathing and
hearbeat (CPR:cardiopulmonary resuscitation). Contact your
local Poison Control Center, hospital, or physician immediately,
In addition to Statement #1, all products which contain
greater than 10% by weight petroleum distillates and are in
Oral Toxicity Category I must carry the following statement
on the label:
2. If patient is conscious, induce vomiting (syrup
of ipecac; if not available, stimulate back of throat with
finger). Never give anything by mouth to an unconscious
personl
In addition to Statement #1, all products which contain
greater than 10% by weight petroleum distillates and are in
Oral Toxicity Category IV must carry the following statement
on the label:
3. Do not induce vomiting!
Products in Oral Toxicity Categories II and III will be
dealt with on a product-by-product basis at the time of
registration; labeling cautions will be based on a review of
active ingredient toxicity, inert ingredients, and impurities.
Because the use pattern indicates the possibility of
exposure to children and pets, all EC Aspon"' products must
carry the following warning: "Keep children and pets off
treated areas for 48 hours and until grass has completely
dried."
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III. Product Chemistry
DISCIPLINARY REVIEW
Chemistry Profile
Data Gaps
Required Labeling
Chemistry Profile
"Aspon®" is a trade name for 0,0,0,0-tetrapropyl
dithiopyrophosphate. No change was reported in the composi-
tion of a 15% EC formulation after 13 months at 68 and
100°F. No other data are available on the physical/chemical
characteristics of any EC formulation.
Data Gaps
Listed below are the Product Chemistry data needed to
obtain registration or re-registration for EC Aspon"^
products. After each data gap is listed the section in the
Proposed Guidelines (July 10, 1978, 43 FR, No. 132, 29696)
which describes that type of data and when it is required.
Guidelines Section
1) Product Identity 163.61-3(a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits 163.61-6(a)
6) Certification of Limits 163.61-6(b)
7) Analytical Methods 163.61-7(a)
8) Analytical Results 163.61-7 (b) (1)
9) Color 163.61-8(c) (1)
10) Odor 163.61-8 (c) (2)
11) Density or Specific Gravity 163.61-8 (c) (8)
12) Storage Stability 163.61-8 (c) (12)
13) Flammability 163. 61-8 (c) (13)
14) Oxidizing or Reducing Action 163.61-8(c) (14)
15) Explosiveness 163.61-8 (c) (15)
16) Miscibility 163. 61-8 (c) (16)
17) Viscosity 163.61-8 (c) (17)
18) Corrosion Characteristics 163.61-8(c) (18)
19) Dielectric Breakdown Voltage 163.61-8 (c) (19)
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Required Labeling
Ingredient Statement; The ingredient statement will
list the active ingredient as 0,0,0,0-Tetrapropyl dithiopyro-
phosphate. If EC products contain petroleum distillates,
the statement "Contains petroleum distillates" must appear
on the label in close proximity to the ingredient statement.
TOPICAL DISCUSSIONS
Corresponding to each of the Topical Discussions
listed below is the number of the section in the 'Pro-
posed Guidelines for Registering Pesticides' of July
10, 1978 (43 FR, No. 132, 29696), which explains the minimum
product Chemistry data needed in order to obtain registration
or reregistration for EC Aspon products.
Guidelines Section
Chemical Identity 163.61-3
Manufacturing Processes 163.61-4
Formation of Unintentional Ingredients... 163.61-5
Ingredients in Pesticide Products 163.61-6
Product Analytical Methods and Data 163.61-7
Physical/Chemical Properties 163.61-8
Chemical Identity
At present, there is no acceptable common name for
the insecticide, 0,0,0,0-Tetrapropyl dithiopyrophosphate.
For a discussion of other identifiers of this active ingredient,
see the Product Chemistry chapter in the section of this
document on manufacturing-use products.
Manufacturing Process
The Agency has no information on present-day manufacturing
processes for any EC product.
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Formation of Unintentional Ingredients
The Agency has no information on the possible formation
of unintentional ingredients in any EC product.
Ingredients in Pesticide Products
For all pesticide products, the Agency requires a
listing of the upper and lower limits established (by
the producer or formulator) for each active ingredient,
and the upper limit for each impurity, reaction product,
and degradation product which is known to be present or
which might reasonably be identified. Currently registered
EC products range from 12.10 to 67.64% a.i.
Product Analytical Methods and Data
No methods for analysis of EC products have been
submitted or reported.
Physical/Chemical Properties
Color; There are no data available on any EC formulation.
Odor; There are no data available on any EC formulation.
Physical State; EC products are in liquid form.
Density o_r Specific Gravity; There are no data available
on any EC or granular formulation.
Storage Stability; Chevron (1975, MRID 000004843}
reports no change in the composition of a 15% EC formulation
after 13 months at 68 and 100°F.
Flammability; No data are available on any EC formulation.
Oxidizing ££ Reducing Action; No data are avail-
able on any EC formulation.
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Explosiveness; No data are available on any EC formula-
tion.
Miscibility; No data are available on any EC formu-
lation.
Viscosity; No data are available on any EC formulation.
Corrosion Characteristics; No data are available on any
EC formulation.
Dielectric Breakdown Voltage; No data are available on
any EC formulation.
BIBLIOGRAPHY
MRID CITATION
000004843 Chevron Chemical Co. 1975. Product research and
services; shelf-life test; Ortho Chinch Bug
Lawn Spray. (Unpublished study received Dec. 3,
1975 under 239-2445; CDL;228761-A.)
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IV. Environmental Fate
DISCIPLINARY REVIEW
Environmental Fate Profile
Exposure Profile
Required Labeling
Environmental Fate Profile
There are no data currently available on the environ-
mental fate of Aspon .
Exposure Profile
Because of the lack of environmental fate data for
Aspon^, the Agency can make only brief generalizations about
the possibility and extent of exposure.
For persons involved in the dilution, mixing, and
application of EC products, there is little chance of oral
-------
Required Labeling
Although there are no data available on the environmental
(R)
fate of Aspon" from which to determine label precautions,
the use pattern (on home lawns) clearly indicates the
possibility of post-application exposure to children and
pets. The following warning must therefore appear on all EC
labels:
"Keep children and pets off treated areas for 48 hours
after application and until the grass has completely
dried."
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V. Toxicology
DISCIPLINARY REVIEW
Toxicology Profile
Toxicology Hazard Assessment
Data Gaps
Required Labeling
Toxicology Profile
The acute dermal toxicity in rabbits (2.0 g/kg) indicates
a potentially low acute dermal toxicity in humans for
the 13% a.i. EC product tested. No data were available to
assess the acute oral or acute inhalation toxicity of
any EC product. Data are insufficient to assess the full
range of acute toxicity of all EC formulations.
Several eye irritation studies conducted on rabbits
showed a wide variety of results (persistent eye irritation
and corneal opacity at day 14 to slight eye irritation at 1
hour and no corneal opacity) which indicate a possibly
severe eye irritant to humans from the 13-14.2% EC product
tested. A study conducted with a 13-14.2% EC on rabbits to
assess primary dermal irritation resulted in severe irritation
at 72 hours which indicates a potentially severe skin
irritant to humans. Sufficient data were not available to
totally assess the primary eye irritation or primary dermal
irritation of all EC formulations.
Toxicology Hazard Assessment
The 'Exposure Profile1 which appears in the Environmental
Fate chapter lists the chance of oral exposure to EC products
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as small with some (unknown) possibility of dietary exposure
from residues on home garden crops. No oral toxicology
hazard assessment can be made for any EC product, however,
because of the lack of data.
Similarly, although some chance of inhalation exposure
to EC products exists, dependant on the vapor pressures and
viscosities of the various products, no inhalation toxicology
hazard assessment can be made for any EC product because of
the lack of data.
Application of EC products can result in dermal exposure
to applicators and homeowners, including ocular exposure.
In addition, for home uses, children and pets may be exposed
to treated lawns. The amount of exposure cannot be determined
(ft
because of data gaps on the environmental fate of Aspon .
Eye exposure to a 13% a.i. EC product can result in
irreversible corneal opacity and severe eye irritation.
Although the acute dermal toxicity of the 13% EC tested is
low to moderate, dermal exposure can result in primary
dermal irritation, including severe irritation or moderate
erythema and edema. No toxicology hazard assessment can be
made for EC products with a percent a.i. higher than 13%
because of the lack of data.
Data Gaps
Listed below are the Toxicology data which must be
submitted or cited to obtain registration or re-registration
-88-
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for EC Aspon** products.* After each data gap is listed
the Section in the Proposed Guidelines of August 22, 1978
(43 PR, No. 163, 37336) which describes that type of data
and when it is required. The Agency has determined that
currently registered EC products between 12% and 28% a.i.
are substantially similar in composition, and that EC
products between 65% and 68% a.i. are substantially similar
in composition. Acute toxicity data available on any one
product in either group may be cited in support of the
registration of any other product in that group, provided
compnesation has been offered for use of these data.
Currently registered EC Aspon™ products which contain
other active ingredients must be tested individually for
each acute effect.
Guidelines Section
ECs Between 12% and 28% a.i.
1) Acute oral toxicity (rat)
on product in upper range
(i.e., @ 25% a.i.) 163.81-1
2) Acute inhalation (rat)
on product in upper range
(i.e., @ 25% a.i.) 163.81-3
ECs Between 65% and 68% a.i.
1) Acute oral toxicity (rat).... 163.81-1
2) Acute dermal toxicity
(rabbit) 163.81-2
3) Acute inhalation (rat) 163.81-3
4) Primary eye irritation
(rabbit) 163.81-4 (c)
OR
Data on pH of the Product.... 163.81-4(b)
5) Primary skin irritation
(rabbit) 163.81-5
* A demonstration that an EC Aspori"' product has a composi-
tion substantially similar to an EC product for which the
Agency already has' acceptable acute toxicity data will
satisfy acute toxicity data requirements for the former
product. Both active and inert ingredients will be considered
in making determinations of similarity.
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ECs With Asponv and Other Active Ingredients
1) Acute oral toxicity (rat) 163.81-1
2) Acute dermal toxicity
(rabbit) 163.81-2
3) Acute inhalation (rat) 163.81-3
4) Primary eye irritation
(rabbit) 163.81-4 (c)
OR
Data on pH of the Product.... 163.81-4(b)
5) Primary skin irritation
(rabbit) 163.81-5
Required Labeling
Product-specific acute toxicity precautionary labeling
is required. Acceptable categories of acute toxicity,
and the corresponding required precautionary labeling
statements, appear in Appendix A to this document.
If the EC Aspon® product has an Acute Oral Toxicity
Category IV and contains greater than 10% by weight petroleum
distillates, the following first aid statement must appear
on the label (see also Table 2, Appendix A):
I_f swallowed; If the patient is unconscious, main-
tain breathing and heart rate (CPRrcardiopulmonary
resuscitation). Contact your local Poison Control
Center, physician, or hospital immediately. Do Not
Induce Vomiting!
(ft
If the EC Aspon'"' product has an Acute Oral Toxicity
Category I and contains greater than 10% by weight petroleum
distillates, the following first aid statement must appear
on the label (see also Table 2, Appendix A):
If^ swallowed: If the patient is unconscious, main-
tain breathing and heart rate (CPRicardiopulmonary
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resuscitation). Contact your local Poison Control
Center, physician, or hospital immediately. If the
patient is conscious, induce vomiting (syrup of ipecac;
if not available, stimulate the back of the throat
with finger). Never give anything by mouth to an
unconscious person!
If the EC Asppn® product has an Acute Oral Toxicity
Category II or III and contains greater than 10% by weight
petroleum distillates, the following first aid statement
must appear on the label (see also Table 2, Appendix A):
I_f swallowed; If the patient 'is unconscious, main-
tain breathing and heart rate (CPR:cardiopulmonary
resuscitation)! Contact your local Poison Control
Center, physician, or hospital immediately.
The question of whether vomiting should or should
not be induced for products with Acute Oral Toxicity Categories
*
of II and III will be determined on a case-by-case basis
based on a review of the toxicity of active ingredients,
inert ingredients, and impurities.
TOPICAL DISCUSSIONS
Corresponding to each of the Topical Discussions
listed below is the number of the section in the 'Proposed
Guidelines' of August 22, 1978 (43 FR, No. 163, 37336) which
explains the minimum Toxicology data needed in order to
obtain registration or reregistration for EC Aspon®
products.
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Guidelines Sections
Acute Effects 163.81-1, -2, and -3
Local Irritation.. 163.81-4 and -5
Acute Effects
Acute Oral Toxicity
The minimum data requirement for testing acute oral
toxicity (LD-50) is one test on a registered product
from each group of substantially similar products (see
the Data Gaps section in this chapter) , preferably using
the laboratory rat. No data are available for assessing
the acute oral LD-50 of any EG product.
Acute Dermal Toxicity
The minimum data requirement for testing acute
dermal toxicity (LD-50) is one test, preferably using
the albino rabbit, for a registered product from each
group of substantially similar products (see the Data
Gaps section in this chapter). The acute dermal LD-50
for a 13-14.2% EC in male rabbits is greater than 2.0
g/kg (Rittenhouse and Narcisse, 1972, MRID 000004838).
Moderate skin irritation was noted but was not persistent
at 72 hours. The data are adequate to assign the
13-14.2% EC product tested to Toxicity Category III for
acute dermal toxicity. Currently registered products
between 12% and 28% should also be assigned to Category
III for acute dermal toxicity. No data are available
for assessing the acute dermal toxicity of any EC
product between 65% and 68% a.i., or any EC product
which contains Aspon® plus other active ingredients.
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Acute Inhalation Toxicity
The minimum data requirement for testing acute
inhalation toxicity (LC-50) is one test for a regis-
tered product from each group of substantially similar
products (see the Data Gaps section in this chapter),
preferably using the laboratory rat. No data are available
for assessing the acute inhalation LC-50 of any EC
product.
-Local Irritation
Primary Eye Irritation
The minimum data requirement for testing primary
eye irritation is one test for a registered product from
each group of substantially similar products (see the
Data Gaps section in this chapter), conducted on a
mammal, preferably the albino rabbit. Data which demons-
trate that the test substance has a pH of 1-3 or 12-14
should be submitted instead of data from a primary eye
irritation test. For all regulatory purposes, the
Agency will assume that substances with the above pH
values or which cause Category I skin effects ar-e
corrosive (i.e., have a Toxicity Category I rating).
Disparate test results were obtained in three
adequate tests conducted on rabbits using a 13% EC
product. In one study (Narcisse,1972, MRID 000004836),
male rabbits were observed for 7 days after applcation
of a 13% EC to the eye. Persistent eye irritation was
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noted at day 7, the last day of observation. Another
study was conducted (Bullock and Narcisse, 1974, MRID
000004835). Male and female rabbits were observed for
14 days after application of a 13% EC product to the
eye. Persistent iritis, conjuctival redness, and
discharge were noted until day 7; corneal opacity was
reported in half the test animals at day 14.
In yet another study (Gregory and Narcisse, 1974,
MRID 000004833), female rabbits were observed for 14
days after application of a 13% EC product to the eye.
Slight eye irritation was noted at 1 hour. No corneal
opacity was noted in any test animal.
The existing data are sufficient to assess the
primary eye irritation potential of the 13% EC product
tested and to place it in Toxicity Category I, indicating
severe eye irritation hazard. Currently registered
products between 12% and 28% a.i. should also be assigned
to Category I for primary eye irritation. No data are
available for assessing the primary eye irritation of
any EC product between 65% and 68% a.i., or any EC
product which contains Aspon™ plus other active
ingredients.
Primary Dermal Irritation
The minimum data requirement for testing primary
dermal irritation is one test for a registered product
from each group of substantially similar products (see
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the Data Gaps section in this chapter) , conducted on a
mammal, preferably the albino rabbit. Narcisse (1972,
MRID 000004837) observed rabbits after application of a
13% EC product to the skin. The dermal exposure resulted
in mild to severe erythema with no edema. The existing
data are adequate to assign the 13% EC product tested to
Toxicity Category II for primary dermal irritation.
Currently registered products between 12% and 28% a.i.
should also be assigned to Category II for primary
dermal irritation. No data are available for assessing
the primary dermal irritation of any EC product between
and 68% a.i., or any EC product which contains
plus other active ingredients.
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BIBLIOGRAPHY
MRID CITATION
000004835 Bullock, C.H.; Narcisse, J.K. 1974. The eye irri-
tation potential of Ortho Chinch Bug Spray (CC
5109): S-668: SOCAL 588/XX:24. (Unpublished study
received Aug. 5, 1974 under 239-765; submitted by
Chevron Cehmical Co., Richmond, Calif.; CDL:022718-A).
000004833 Gregory, L.K.; Narcisse, J.K. 1974. The eye irrtiation
potential of CC-5495: S-745: SOCAL 674/XX:117. (Un-
published study received June 25, 1975 under 239-765;
submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:220001-C).
000004836 Narcisse, J.K. 1972. Eye irritation potential of Ortho
Bug Spray: S-362: SOCAL 283/71:114. (Unpublished
study received Nov. 14, 1974 under 239-765; submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:051023-A)
000004837 Narcisse, J.K. 1972. Skin irritation potential of
Ortho Chinch Bug Spray: S-363: SOCAL 284B/VI:114.
(Unpublished study received Nov. 14, 1974 under 239-765;
submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:051023-B).
000004838 Rittenhouse, J.R.; Narcisse, J.K. 1972. The acute dermal
toxicity of Ortho Chinch Bug Spray: S-363: SOCAL
284A/VI:117. (Unpublished study received Nov. 14, 1974
under 239-765; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:051023-C).
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VI. Ecological Effects
DISCIPLINARY REVIEW
Ecological Effects Profile
Required Labeling
Ecological Effects Profile
The available data show that a 13% EC is highly
toxic to fish and freshwater aquatic invertebrates, the
invertebrates being more sensitive than fish.
Tests on a 13% EC indicate that there is no phytotoxicity
to turf grass if used at recommended rates (3.7 pounds a.i.
per acre) , and that it is only slightly phytotoxic to
certain varieties of turf at 2 to 4 times recommended
rates.
Required Labeling
Based on data discussed in the Manufacturing-Use section
of this document, all EC products must bear the label
warning: "This pesticide is toxic to fish. Do not contaminate
water by cleaning of equipment or disposal of wastes."
TOPICAL DISCUSSIONS
Applicants for registration of end-use EC products are
not required to submit information on ecological effects.
The following discussions present supplemental information
available to the Agency on EC formulations.
Terrestrial Plants
Tests on a 13% EC (Chevron, 1971, MRID 000004849)
indicate that there is no phytotoxic response by turfgrasses
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when used at the recommended rate of 3.7 pounds a.i. per
acre. The response to the EC varies from no reaction to
moderate phytotoxic symptoms when used at 2 to 4 times the
recommended rate, depending on the variety of turfgrass
tested (Lindemann 1974). This type of data is not, at
present, required for registration.
Aquatic Invertebrates
A 48-hour toxicity test (EPA, 1975, MRID GS0019-011)
using a 13% EC formulation was performed on the water flea,
Daphnia magna. The 48-hour LC-50 = 0.625 ppm (0.5 to 0.77
ppm, 95% c.i.). These data are sufficient to characterize a
13% EC formulation as highly toxic to aquatic invertebrates.
Freshwater Fish
Data discussed in the section on Manufacturing-use
products indicate that Aspon*^ can be considered very
highly toxic to coldwater and warmwater fish species.
Addtional data, which are summarized in Table 7,
are also available on the 96-hour LC-50 of a 13% EC formula-
tion. These data indicate that the 13% EC formulation
tested is highly toxic to rainbow trout.
Table 7. Acute Toxicity of Formulated Aspon*
Products to Freshwater Fish
Species
Rainbow Trout
Formulation
13%
EC
LC-50
(ppm)
1.0
Reference
EPA, 1975,
MRID GS0019-
011
1
1
1
1
1
1
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BIBLIOGRAPHY
MRID CITATION
000004849 Chevron Chemical Co. 1971. Summary: Ortho Sod
Webworm Control. (Unpublished study including
OR 513 report nos. 387-1, 387-41, 621-37, 621-36,
623-07, 623-06, 504-23, received Dec. 20, 1971
under 239-2389; CDL:001557-A).
GS0019-011 EPA. 1975. Report on the toxicity of Ortho Sod
Webworm (13% active ingredient) to Daphnia magna.
(U.S. EPA, Chemical and Biological Investigations
Branch, Beltsville, Maryland, Static jar test No.
865, 8/21/75, unpublished.)
GS0019-012 EPA. 1975. Report on the toxicity of Ortho Sod-Webworm
13% active ingredient to rainbow trout. (U.S. EPA,
Chemical and Biological Investigations Branch, Belts-
ville, Maryland, Static jar test No. 848, 7/8/75,
unpublished report.)
000005003 Lindemann, R.H.; Massey, V.C.; Coltharp, J.L.; Bryant,
W.F. 1974. Product performance report: OR report no.
657-10. (Unpublsihed study including OR-513 report
nos. 705-41, 748-21, 748-22, 705-25, 705-23 and 705-42,
received June 25, 1975 under 239-2389; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:133068-C).
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GRANULAR ASPO
I. Regulatory Position
A. Regulatory Decision
The Agency has reviewed all data available to it.
Although incomplete, these data indicate that granular
Aspon® is suitable for registration because it does not
meet or exceed the risk criteria leading to a Rebuttable
Presumption Against Registration [Chapter 40, Section
162.11(a) of the Code of Federal Regulations], Data gaps
have been identified; when these data are supplied/ the
Agency will again review the registration status of this
compound.
The Agency has determined that granular Aspon^ does
not appear to cause an unreasonable adverse effect with
proper label directions and precautions. Those granular
products currently registered may be reregistered subject to
the conditions imposed for data requirements, and new
products may also be registered under the terms of this
Standard.
B. Criteria for Registration under the Standard
To be registered under this Standard, granular Aspon®
products must meet the following conditions:
1. The granular product contains Aspon®
as an active ingredient [if an unregistered source of
Aspon™ is used in formulating, then the data outlined
under Section 162.18-2(c) (d) (1) (ill) will be required];
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2. The granular Aspon™ product is within the acute
toxicity limits for restricted or general use and bears the
required labeling;
3. The granular Aspon® product is within acceptable
ranges for use patterns and application methods; and
4. The applicant for registration of granular products
complies with all other terms and conditions specified in
this Standard and hereby offers to pay compensation to other
persons, with regard to approval of this application, to the
extent required by 3(c)(l)(d) and 3(c)(2)(d) of the Federal
Insecticide, Fungicide, and Rodenticide Act [FIFRA], as
amended, 7 U.S.C. 136(c)(l)(d) and 136 (c) (2) (D) .
C. Acceptable Ranges and Limits
1. Product Composition Standards
To be covered under this Standard, all granular products
must contain Aspon® [0,0,0,0-Tetrapropyl dithiopyrophosphate]
as an active ingredient. The Agency will consider for
registration granular products which contain any percentage
of active ingredient. In addition, currently registered and
proposed granular products must agree to submit or cite the
information on product composition identified as data
gaps in Section I.D of this document
Standards have not yet been set for contaminants and
inerts in granular Aspon" products. When standards are
set for any contaminants or inerts in granular Aspon®
products, granular end-use products must comply with those
standards.
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2. Acute Toxicity Limits
a. Restricted Use
The Agency will grant registration to granular
products as restricted pesticides (i.e., for retail sale to
and application only by Certified Applicators or persons
under their direct supervision) for non-food, outdoor use
which have a Toxicity Category I rating for any of the
following acute effects:
1) Acute Oral Toxicity;
2) Acute Dermal Toxicity;
3) Acute Inhalation Toxicity;
4) Primary Eye Irritation; or
5) Primary Dermal Irritation.
b. Non-Domestic Use
The Agency will grant registration to granular Aspon®
products intended for non-domestic, non-food, outdoor use
which have a Toxicity Category II rating for any of the
following acute effects:
1) Acute Oral Toxicity;
2) Acute Dermal Toxicity; or
3) Acute Inhalation Toxicity;
The Agency will grant registration to granular Aspon®
products intended for non-domestic, non-food, outdoor
use which have a Toxicity Category I or II rating for
either of the following acute effects:
1) Primary Eye Irritation; and
2) Primary Dermal Irritation.
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c. Domestic Use
The Agency will grant registration to granular
products intended for domestic, non-food, outdoor use which
have a Toxicity Category III or IV rating for any of the
following acute effects:
1) Acute Oral Toxicity;
2) Acute Dermal Toxicity; or
3) Acute Inhalation Toxicity;
The Agency will grant registration to granular Aspon®
products intended for domestic, non-food, outdoor use which
have a Toxicity Category I through IV rating for either of
the following acute effects:
1) Primary Eye Irritation; and
2) Primary Dermal Irritation.
3. Use Patterns and Application Methods
To be covered under this Standard, granular products may
be used only as an insecticide on home lawns or ornamental
turf. Application may not be made aerially. Currently
registered granular products must retain present recommen-
dations for dosage rates on the labels. Applicants who wish
to increase the dosage recommendations on currently registered
products, or who wish to register new products with higher
dosage recommendations than those currently registered may
be required to submit additional supporting data.
D. Data Gaps
To be covered under this Standard, applicants for
registration or reregistration of granular Aspon® products
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must agree to submit or cite the following information on
the physical/chemical composition and toxicity of each
proposed product. After each data gap is listed the
section in the Proposed Guidelines which describes that type
of data and when it is required [43 FRf No. 132, 29696 of
July 10, 1978; and 43 FR, No. 163, 37336 of August 22,
1978] .
Guidelines Section
Product Chemistry
1) Product Identity 163.61-3(a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits 163.61-6(a)
6) Certification of Limits 163.61-6(b)
7) Analytical Methods 163.61-7(a)
8) Analytical Results 163.61(b)(l)
9) Color 163.61-8(0(1}
10) Odor 163.61-8(c) (2)
11) Density or Specific Gravity 163.61-8(c) (8)
12) Storage Stability 163.61-8 (c) (12)
13) Oxidizing or Reducing Action 163.61-8(c)(14)
14) Explosiveness 163.61-8 (c) (15)
15) Corrosion Characteristics 163.61-8(c) (18)
*Toxicology
Granulars Between 1% and 6%
1) Acute inhalation (rat)** 163.81-3
*A demonstration that a granular Aspon^ product has
a composition substantially similar to a granular product
for which the Agency already has acceptable acute toxicity
data will satisfy acute toxicity data requirements for
the former product. Both active and inert ingredients will
be considered in making determinations of similarity.
** An acute inhalation toxicity study is required for
granular products if "20 percent or more of the aerodynamic
equivalent of the formulated product (as registered or under
conditions of use) is composed of particulates not larger
than 10 microns in diameter" [Guidelines Section
163.81-3(a) (2) (ii)]. An acute inhalation test on any
currently registered granular product between 1% and 6% a.i.
may be submitted or cited in support of the registrations of
all currently registered granular products. A request for
a waiver of this requirement based on percent of particulates
not larger than 10 microns must be made individually
for each product.
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E. Required Labeling
1. Product Chemistry
The ingredient statement will list the active ingredient
as: 0,0,0,0-Tetrapropyl dithiopyrophosphate. In all cases,
the percentages by weight of active ingredient and inerts
must equal 100%.
Active Ingredient:
0,0,0,0-Tetrapropyl dithiopyrophosphate %
Inert Ingredients %_
Total 100%
2. Human Hazard - Precautionary Labeling
The hazard warnings and first aid statements on all
granular product labels must correspond to the Toxicity
Category assigned to that product for each acute effect
(see Appendix A). Specifically, all currently registered
granulars between 1% and 6% a.i. must carry on the label
the acute toxicity hazard warnings and first aid state-
ments required for the following Toxicity Categories:
Granulars Without Fertilizer
1) Acute Oral Toxicity - III
2) Acute Dermal Toxicity - III
3) Primary Eye Irritation - III
4) Primary Dermal Irritation - III
Granulars With Fertilizer
1) Acute Oral Toxicity - III
2) Acute Dermal Toxicity - III
3) Primary Eye Irritation - II
4) Primary Dermal Irritation - III
3. Environmental Fate
Because the use pattern clearly indicates the possibility
of post-application exposure to children and pets, the
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following warning must appear on all granular labels: "Keep
children and pets off treated areas for 48 hours after
application and until the grass has completely dried."
Other environmental precautions not in conflict with specific
parts of this Standard should be retained.
4. Environmental Hazards
All granular products must bear the label warning:
"This pesticide is toxic to fish. Do not contaminate water
by cleaning of equipment or disposal of wastes."
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II. Regulatory Rationale
A. Regulatory Decision
-------
Category I rating because certified applicators can legiti-
mately be expected to provide the specialized protective
clothing (for themselves or those under their supervision)
which are required for products with Toxicity Category I
rating.
b. Non-Domestic Use
The Agency will register granular Aspon® products
for non-domestic, non-food, outdoor use which have a Toxicity
Category II rating for acute oral, dermal, or inhalation
toxicity, or which have a.Toxicity Category I or II rating
for primary eye or dermal irritation, because non-domestic
users can legitimately be expected to provide the specialized
protective clothing (for themselves or their employees)
which are required for products with these Toxicity Category
ratings. The Agency considers that these restrictions,
together with use of the required protective clothing, will
adequately protect humans from unreasonable adverse effects.
c. Domestic Use
The Agency will register granular Aspon^ products for
domestic, non-food, outdoor use which have a Toxicity
Category III or IV rating for acute oral, dermal, or inhala-
tion toxicity, or which have a Toxicity Category I through
IV rating for primary eye or dermal irritation. Granular
products intended for domestic use with Toxicity Category I
or II ratings for primary eye or dermal irritation must meet
the criteria for child-resistant packaging [see PR 44(48):
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13019-13024, March 9, 1979]. The Agency considers that the
economic and aesthetic benefits from Aspon^ use outweigh
the risks from products with acute Toxicity Category ratings
of III or IV, and that the use of child-resistant packaging
for products with Toxicity I or II ratings for primary eye
or dermal irritation will adequately protect humans from
unreasonable adverse effects.
3. Use Patterns and Application Methods
Granular Aspon® products may be registered for use as
an insecticide only on lawns and ornamental turf. Granular
products may not be used on food crops because the hazard of
such uses and of residue ingestion has not been evaluated
nor has such an evaluation been requested. Application may
not be made aerially because this method can reasonably be
expected to result in high exposures to applicators, other
persons, or wildlife close to the application site. Currently
registered granular products must retain the dosage recommen-
dations on the labels, in the absence of data to support
higher rates.
C. Data Gaps
The data on the physical/chemical composition and acute
toxicity which applicants are required to submit or cite for
granular Aspon*^ products are listed in Section I.D of this
document. These data are required in order to obtain
registration for any proposed end-use product.
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D. Required Labeling
Acute toxicity hazard warnings must accurately reflect
the product's level of toxicity (products may not be labeled
to show either greater or lesser hazard from the product
than in fact exists). Because the use pattern indicates the
possibility of exposure to children and pets, all granular
(R)
Aspon** products must carry the following warning: "Keep
children and pets off treated areas for 48 hours and until
grass has completely dried."
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TTT. Product Chemistry
DISCIPLINARY REVIEW
Chemistry Profile
Data Gaps
Required Labeling
Chemistry Profile
"Aspon®" is a trade name for 0,0,0,0-tetrapropyl
dithiopyrophosphate. No data are available on the physical/-
chemical characteristics of any granular formulation.
Data Gaps
Listed below are the Product Chemistry data which must
be submitted or cited to obtain registration or re-registra-
(ft
tion for granular Aspon^ products. After each data gap is
listed the section in the Proposed Guidelines (July 10,
1978, 43 PR, No. 132, 29696) which describes that type of
data and when it is required.
Guidelines Section
1) Product Identity 163.61-3(a)
2) Disclosure of Ingredients 163.61-3(c)
3) Description of Manufacturing
Process 163.61-4
4) Formation of Unintentional
Ingredients 163.61-5
5) Declaration of Limits 163.61-6(a)
6) Certification of Limits 163.61-6(b)
7) Analytical Methods 163.61-7(a)
8) Analytical Results 163.61(b)(l)
9) Color 163.61-8(c) (1)
10) Odor 163.61-8(c) (2)
11) Density or Specific Gravity 163.61-8 (c) (8)
12) Storage Stability 163.61-8 (c) (12)
13) Oxidizing or Reducing Action 163.61-8 (c) (14)
14) Explosiveness 163.61-8 (c) (15)
15) Corrosion Characteristics 163.61-8 (c) (18)
Required Labeling
Ingredient Statement; The ingredient statement will
list the active ingredient as 0,0,0,0-Tetrapropyl dithiopyro-
phosphate.
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TOPICAL DISCUSSIONS
Corresponding to each of the Topical Discussions
listed below is the number of the section in the 'Pro-
posed Guidelines for Registering Pesticides' of July
10, 1978 (43 FR, No. 132, 29696), which explains the minimum
Product Chemistry data needed in order to obtain registration
or reregistration for granular Aspon™ products.
Guidelines Section
Chemical Identity 163.61-3
Manufacturing Processes 163.61-4
Formation of Unintentional Ingredients... 163.61-5
Ingredients in Pesticide Products 163.61-6
Product Analytical Methods and Data 163.61-7
Physical/Chemical Properties 163.61-8
Chemical Identity
At present, there is no acceptable common name for
the insecticide, 0,0,0,0-Tetrapropyl dithiopyrophosphate.
For a discussion of other identifiers of this active ingredient,
see the Product Chemistry chapter in the section of this
document on manufacturing-use products.
Manufacturing Process
The Agency has no information on present-day manufacturing
processes for any granular product.
Formation of Unintentional Ingredients
The Agency has no information on the possible formation
of unintentional ingredients in any granular product.
Ingredients in Pesticide Products
For all pesticide products, the Agency requires a
listing of the upper and lower limits established (by the
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producer or formulator) for each active ingredient, and
the upper limit for each impurity, reaction product, and
degradation product which is known to be present or which
might reasonably be identified. Currently registered
granular products range from 1.32% to 5% a.i.
Product Analytical Methods and Data
No methods for analysis of granular products have been
submitted or reported.
Physical/Chemical Properties
Color; There are no data available on any granular
formulation.
Odor; There are no data available on any granular
formulation.
Physical State; Granular products are in solid form.
Density ojr Specific Gravity; There are no data available
on any granular formulation.
Storage Stability; There are no data available on any
granular formulation.
Oxidizing ££ Reducing Action; No data are avail-
able on any granular formulation.
Explosiveness; No data are available on any granular
formulation.
Corrosion Characteristics; No data are available on any
granular formulation.
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IV. Environmental Fate
DISCIPLINARY REVIEW
Environmental Fate Profile
Exposure Profile
Required Labeling
Environmental Fate Profile
There are no data currently available on the environ-
(ft
mental fate of Aspon**.
Exposure Profile
Because of the lack of environmental fate data for
(ft
Aspon", the Agency can make only brief generalizations
about the possibility and extent of exposure.
For persons involved in the application of granular
products, there is little chance of oral exposure except
through accidental ingest ion. Aspon® is not registered
for use on food or feed crops, so there is very little
possibility of dietary exposure to the general public.
(Depending on the leaching and mobility characteristics of
the granular products, home use may result in contamination
of home garden vegetables.) Dermal and eye exposure to
granular formulations (and to dust particles of the formula-
tions) can occur. Inhalation exposure to granular formulations
can also occur through inhalation of dust-sized particles by
applicators and homeowners.
Required Labeling
Although there are no data available on the environmental
fate of Aspon^ from which to determine label precautions,
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the use pattern (on home lawns) clearly indicates the
possibility of post-application exposure to children and
pets. The following warning must therefore appear on all
granular labels:
"Keep children and pets off treated areas for 48 hours
after application and until the grass has completely
dried."
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V. Toxicology
DISCIPLINARY REVIEW
Toxicology Profile
Toxicology Hazard Assessment
Data Gaps
Required Labeling
Toxicology Profile
The acute oral toxicity in rats (males, >6.0 g/kg;
females = 3.4 g/kg) indicates a potentially low acute oral
toxicity in humans for the 3.2-3.9% granular product tested.
The acute dermal toxicity in rabbits (4.65 g/kg) indicates a
potentially low acute dermal toxicity in humans for the 5%
granular tested. No data were available to assess the acute
inhalation toxicity of any granular product. Data are
insufficient to assess the full range of acute toxicity of
all granular formulations.
An eye irritation study conducted on rabbits indicates a
mild, transitory eye irritation potential for humans from
the 3.2% granular (without fertilizer) tested. A study
conducted on rabbits to assess primary dermal irritation
indicates a slight, transitory dermal irritation potential
for humans from the 3.2% granular tested. Data on other
active ingredient products which contain fertilizer indicate
a possible increase in the primary eye irritation potential
of such products from the fertilizer component.
Toxicology Hazard Assessment
The 'Exposure Profile1 which appears in the Environmental
Fate chapter lists the chance of exposure to granular
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products as small with some (unknown) possibility of dietary
exposure from residues on home garden crops. The acute oral
toxicity of a 3.9% granular product is low. Whether possible
oral exposure to granular products would occur at levels
high enough to be of concern cannot be determined, because
of the lack of data.
Similarly, although some chance of inhalation exposure
to granular products exists, dependant on the size of the
dust particles of the formulations, no inhalation toxicology
hazard assessment can be made for any granular product
because of the lack of data.
Application of granular products can result in dermal
exposure to applicators and homeowners, including ocular
exposure from dust particles of the product. In addition,
for home uses, children and pets may be exposed to treated
lawns. The amount of exposure cannot be determined because
of data gaps on the environmental fate of Aspon^. Data
indicate that a 3.2% a.i. granular product has low acute
dermal toxicity and low primary dermal irriation. The
primary eye irriation potential of a 5% a.i. granular
product is also low. Whether possible dermal and eye exposure
to granular products would occur at levels high enough to be
of concern cannot be determined because of the lack of
data.
Data Gaps
Listed below are the Toxicology data which must be
submitted or cited to obtain registration or re-registration
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for granular Asporv^ products.* After each data gap is
listed the Section in the Proposed Guidelines of August 22,
1978 (43 FR, No. 163, 37336) which describes that type of
data and when it is required. The Agency has determined
that currently registered granular products between 1% and
6% a.i. are substantially similar in composition, except
that currently registered granular Aspon™ products between
1% and 6% a.i. which contain fertilizer will be considered
substantially similar in composition for determining primary
eye irritation. Acute toxicity data available on any one
product in either group may be cited in support of the
registration of any other product in that group, provided
compensation has been offered for use of these data.
Guidelines Section
Granulars Between 1% and 6%
1) Acute TrThanTtTon (rat)** 163.81-3
*A demonstration that a granular Aspon0' product has
a composition substantially similar to a granular product
for which the Agency already has acceptable acute toxicity
data will satsify acute toxicity data requirements for
the former product. Both active and inert ingredients will
be considered in making determinations of similarity.
** An acute inhalation toxicity study is required for
granular products if "20 percent or more of the aerodynamic
equivalent of the formulated product (as registered or under
conditions of use) is composed of particulates not larger
than 10 microns in diameter" [Guidelines Section
163.81-3(a) (2) (ii)]. An acute inhalation test on any
currently registered granular product between 1% and 6% a.i.
may be submitted or cited in support of the registrations of
all currently registered granular products. A request for
a waiver of this requirement based on percent of particulates
not larger than 10 microns must be made individually
for each product.
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Required Labeling
Product-specific acute toxicity precautionary labeling
is required. Acceptable categories of acute toxicity,
and the corresponding required precautionary statements,
appear in Appendix A to this document.
TOPICAL DISCUSSIONS
Corresponding to each of the Topical Discussions
listed below is the number of the section in the 'Proposed
Guidelines' of August 22, 1978 (43 FR, No. 163, 37336)
which explains the minimum Toxicology data needed in order
to obtain registration or reregistration for granular
(Ok
Aspon0' products.
Guidelines Sections
Acute Effects 163.81-1, -2, and -3
Local Irritation 163.81-4 and -5
Acute Effects
Acute Oral Toxicity
The minimum data requirement for testing acute
oral toxicity (LD-50) is one test on any registered
product between 1% and 6% a.i., preferably using the
laboratory rat. The acute oral LD-50 for a 3.2-3.9%
a.i. granular is 6.0 g/kg for male rats and 3.4 g/kg for
female rats (Eisenlord, 1978, MRID 000004857). The data
indicate that the 3.2-3.9% granular tested should be
assigned Toxicity Category III for acute oral toxicity.
Currently registered products between 1% and 6% a.i. -
should also be assigned to Category III for acute oral
toxicity.
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Acute Dermal Toxicity
The minimum data requirement for testing acute
dermal toxicity (LD-50) is one test, preferably using
the albino rabbit, for any registered product between 1%
and <5% a.i. The acute dermal LD-50 for a 5% granular in
rabbits is 4.65 g/kg (Bullock, 1970, MRID 000004858).
No skin irritation or signs of toxicity were noted at
this dose level. The data indicate that the 5% granular
tested should be assigned Toxicity Category III for
acute dermal toxicity. Currently registered products
between 1% and 6% a.i. should also be assigned to
Category III for acute dermal toxicity.
Acute Inhalation Toxicity
The minimum data requirement for testing acute
inhalation toxicity (LC-50) is one test for any regis-
tered product between 1% and 6% a.i., preferably using
the laboratory rat. An acute inhalation toxicity study
is required for granular products if "20 percent or more
of the aerodynamic equivalent of the formulated product
(as registered or under conditions of use) is composed
of particulates not larger than 10 microns in diameter"
[Guidelines Section 163 .81-3 (a) (2) (ii) ] . An acute
inhalation test on any currently registered granular
product between 1% and 6% a.i. may be submitted or cited
in support of the registrations of all currently registered
granular products. A request for a waiver of this
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requirement based on percent of participates not larger
than 10 microns must be made individually for each
product. No data are available for assessing the acute
inhalation LC-50 of any granular product.
Local Irritation
Primary Eye Irritation
The minimum data requirement for testing primary
eye irritation is one test for a registered product from
each group of substantially similar products, conducted
on a mammal, preferably the albino rabbit (unless the
pesticide product has a pH of 1-3 or 12-14 or demonstrates
severe skin corrosivity). Data which demonstrate that
the test substance has a pH of 1-3 or 12-14 will be
submitted instead of data from a primary eye irritation
test. For all regulatory purposes, the Agency will
assume that substances with the above pH values or Which
cause Category I skin effects are corrosive (i.e.,
have a Toxicity Category I rating). [For purposes
of determining primary eye irritation potential, the
Agency has determined that there are two groups of
substantially similar granular Aspon^ products: 1)
those between 1% and 6% a.i. which do not contain
fertilizer, and 2) those between 1% and 6% a.i. which jJo
contain fertilizer.]
A primary eye irritation study was conducted on
rabbits using a 3.2% granular without fertilizer (Bullock,
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1976, MRID 000004861). The application (0.1 ml) of the
3.2% granular in the eye resulted in moderate, transient
conjunctival redness and a slight discharge of the
conjunctivae at 1 hour; all eyes were normal at 24
hours. In addition, no corneal opacity was observed.
The data are adequate to assign the 3.2% granular tested
to Toxicity Category III for primary eye irritation.
Currently registered products between 1% and 6% a.i.
which do not contain fertilizer should also be assigned
to Category III for primary eye irritation.
(R)
Data available on non-Aspon'0' products with
fertilizer indicate that such products should be
assigned to Toxicity Category II for primary eye irrita-
tion (The Andersons [sic], 1980, GS0019-019; Biesemeior,
1978, GS0019-020; O.M. Scott & Sons, Co., 1979, GS0019-021;
O.M. Scott & Sons, Co., 1979, GS0019-022; Raltech
Scientific Services, Inc., 1980, GS0019-023; Thompson,
1980, GS0019-024; Thompson, 1979, GS0019-025; Thompson,
1980, GS0019-026). In the absence of specific data, the
/p|
Agency assumes that Asponv°' products with fertilizer
should also be assigned to Toxicity Category II for
primary eye irritation. When the data requested on
product chemistry of granular products have been submitted,
the Agency will review those data to determine substantial
similarity of composition, in which case Category II
will be assigned. If similarity cannot be established,
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additional testing will be required of the applicant to
establish an appropriate eye irritation toxicity category
Registrants also have the option of submitting data on
the pH of their product (if appropriate) or submitting
data from a primary eye irritation test on their specific
product.
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Primary Dermal Irritation
The minimum data requirement for testing primary
dermal irritation is one test for any registered product
between 1% and 6% a.i., conducted on a mammal, preferably
the albino rabbit. Eisenlord (1978, MRID 000004859)
observed rabbits after application of a 3.2% granular
product to the skin. Transient, slight erythema with
and without edema was observed at 24 and 48 hours;
however all animals were normal at 72 hours. The
data are adequate to assign the 3.2% granular tested
to Toxicity Category III for primary dermal irritation.
Currently registered products between 1% and 6% a.i.
should also be assigned to Category III for primary
dermal irritation.
BIBLIOGRAPHY
MRID CITATION
000004858 Bullock, C.H. 1970. Toxicology lab report—T 1520;
T 1549. (Unpublished study received Apr. 18, 1978
under 239-2032; prepared by Stauffer Chemical Co.,
submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:234497-C).
000004861 Bullock, C.H. 1976. The eye irritation potential of
CC 7187: S-972; SOCAL 937/27:76. (Unpublished
study received Apr. 18, 1978 under 239-2032; sub-
mitted by Chevron Chemical Co., Richmond, Calif.;
CDL:234497-F).
000004857 Eisenlord, G.H. 1978. The acute oral toxicity of
Ortho Chinch Bug and Sod Webworm Control: S-1178;
SOCAL 1179/31: 116. (Unpublished study received
Apr. 18, 1978 under 239-2032; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:234497-B).
000004859 Eisenlord, G.H. 1978. The skin irritation potential
of .Ortho Chinch Bug and Sod Webworm Control: S-1179;
SOCAL 1180/30:132. (Unpublished study received Apr.
18, 1978 under 239-2032; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:234497-D).
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Addenda
MRID
GS0019-019
GS0019-020
GS0019-021
GS0019-022
GS0019-023
GS0019-024
GS0019-025
GS0019-026
CITATION
The Andersons [sic], 1979. Primary eye irritation
study in .the albino rabbit, primary skin irritation
study in the albino rabbit, acute dermal toxicity
study in the albino rabbit, acute oral toxicity study
in rats - Turf Care 20-4-10 with Benefin and chlor-
pyrifos. (Unpublished studies, received May 30,
1979, under 9198-37).
Biesemeior, J. 1978. Toxicology lab report [acute
oral LD-50, acute dermal LD-50, skin irritation, eye
irritation] reference no. F-8649. (Unpublished study
received Apr. 24, 1979, under 538-156; prepared by
Raltech Scientific Services, Inc. [Warf Institute,
Madison, Wis.]; submitted by O.M. Scott & Sons, Marys-
ville, Ohio).
O.M. Scott & Sons, Co. 1979. Acute oral toxicity,
acute dermal toxicity, primary eye irritation, primary
dermal irritation - Kwit and Western Lawn Insect
Control. (Unpublished studies received May 5, 1980,
under 538-69.)
O.M. Scott & Sons, Co. 1979. Acute oral toxicity,
acute dermal toxicity, primary eye irritation, primary
dermal irritation - Western Lawn Insect Control Plus
Fertilizer. (Unpublished study received May 5, 1980,
under 538-94.)
Raltech Scientific Services, Inc. 1980. Eye irrita-
tion, Lab report 760871. (Unpublshed study received
May 1, 1980 under 538-137; submitted by O.M. Scott &
Sons Co., Marysville, Ohio.)
Thompson, G.W. 1980. The primary eye irritation study
of F6713. (Unpublished study received June 12, 1980,
under 538-72; prepared by Raltech Scientific Services,
Inc.; submitted by O.M. Scott & Sons, Marysville, Ohio.
Accession # 243155.)
Thompson, G.W. 1979. Toxicology lab report - F9348.
(Unpublished study received Nov. 6, 1979, under 538-160;
prepared by Raltech Scientific Services, Inc.; submitted
by O.M. Scott & Sons, Marysville, Ohio. Accession #
241350.)
Thompson, G.W. 1980. Toxicology lab report (acute
oral LD-50, acute dermal LD-50, skin irritation and eye
irritation), lab report 765242. (Unpublished study
received March 24, 1980, under 538-163; prepared by
Raltech Scientific Services, Inc.; submitted by O.M.
Scott & Sons, Marysville, Ohio.)
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VI. Ecological Effects
DISCIPLINARY REVIEW
Ecological Effects Profile
Required Labeling
Ecological Effects Profile
Information on the acute toxicity of a granular form to
laboratory mammals is supplied in the Toxicology chapter.
The toxicity of a 3.2% formulation ranges from "slightly" to
"practically non-toxic" to rats. A 3.2% granular is moderately
toxic to warmwater fish. Tests on a 3.2% granular formulation
indicate no phytotoxic response by turf when the product is
applied at 14.6 pounds a.i. per acre, which is 4 times the
recommended rate.
Required Labeling
Based on data discussed in the Manufacturing-Use section
of this document, all granular products must bear the label
warning: "This pesticide is toxic to fish. Do not contaminate
water by cleaning of equipment or disposal of wastes."
TOPICAL DISCUSSIONS
Applicants for registration of end-use granular products
are not required to submit information on ecological effects.
The following discussions present supplemental information
available to the Agency on granular formulations.
Terrestrial Plants
Tests on a 3.2% granular product (Chevron, 1974, MRID
000004854) indicate no phytotoxic response by turf when
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exposed to 14.6 pounds a.i. per acre, which is 4 times the
recommended rate. This type of data is not, at present,
required for registration.
Freshwater Fish
Data discussed in the section on Manufacturing-use
products indicate that Aspon® can be considered very
highly toxic to coldwater and warmwater fish species.
Additional data, which are summarized in Table 3,
are also available on the 96-hour LC-50 of a 3.2% granular
formulation. The data indicate that the 3.2% granular is
moderately toxic to bluegills.
Table 3. Acute Toxicity of Formulated Aspon*
Products to Freshwater Fish
Species
Bluegill
Bluegill
Formulation
3.2% Gran.
3.2% Gran.
LC-50
(ppm)
5.6
3.8
Reference
EPA, 1975,
MRID GS0019-
013
EPA, 1975,
MRID GS0019-
014
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BIBLIOGRAPHY
MRID CITATION
000004854 Chevron Chemical Co. 1974. Aspon, Dursban (Unpublished
study including report nos. 627.02, 627.27, 623.09-
623.12, 504.23, 504.26, 366.10, 658.29, 657.35, 519.23,
748.20, 727.23, 519.30, 727.24, 727.30, 627.23, 627.24,
received May 6, 1975 under 239-2032; CDL:222347-C).
GS0019-013 EPA. 1975. Report on the toxicity of Ortho Chinch Bug
Control, 3.2% a.i., to bluegills. (U.S. EPA, Belts-
ville, Maryland, Static jar test No. 876, 9/22/75,
unpublished report.)
GS0019-014 EPA. 1975. Report on the toxicity of Ortho Chinch Bug
Control on bluegills. (U.S. EPA, Chemical and Bio-
logical Investigations Branch, Beltsville, Maryland,
Static jar test No. 866, 8/21/75, unpublished.)
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Guide to Use of This Bibliography
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. The bibliography is divided into 3
sections: (1) citations that contributed information
useful to the review of the chemical and considered to
be part of the data base supporting registrations under
the Standard, (2) citations examined and judged to be
inappropriate for use in developing the Standard, and
(3) standard reference material. Primary sources for
studies in this bibliography been the body of data
submitted to EPA and its predecessor agencies in support
of past regulatory decisions, and the published technical
literature.
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 EPA, the Agency
has sought tof 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.
Identification of Entries. The entries in this bibliog-
raphy are sorted by author, date of the document, and
title. Each entry bears, to the left of the citation
proper, an eight-digit numeric identifier. 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.
Form of the Entry. In addition to the Master Record
Identifier (MRID), each entry consists of a bibliographic
citation containing standard elements followed, in
the case of materials submitted to EPA, by a description
of the earliest known submission. The bibliographic
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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 an author could confidently be
identified, 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 the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory test) the
following elements describing the earliest known
submission:
(1) Submission Date. Immediately following the
word 'received* appears the date of the earliest
known submission.
(2) Administrative Number. The next element,
immediately following the word 'under1, is the
registration number, experimental permit
number, petition number, or other administrative
number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter,
following the phrase 'submitted by'. When
authorship is defaulted to the submitter,
this element is omitted.
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(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.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting Registrations Under the Standard
Product Chemistry
MRID CITATION
000004843 Chevron Chemical Company. 1975. Product research
and services: shelf-life test - Ortho Chinch
Bug Lawn Spray. (Unpublished study received Dec.
3f 1975 under 239-2445; CDL:228761-A)
GS0019-001 Ja, W., W.J. Smith, and J.F. Below. 1966. The
analysis of technical Aspon, Richmond report
no. RR-66-35. Stauffer Chemical Co., New York, N.Y.
005004395 Keith, L.H.; Garrison, A.W.; Alford, A.L. 1968.
The high resolution NMR spectra of pesticides.
I. organophosphorus pesticides. J. Assoc. Off.
Anal. Chem. 51(5):1063-1094.
005001354 McMahon, B.; Bourke, J.A. 1978. Analytical behavior
data for chemicals determined using AOAC multi-
residue methodology for pesticide residues in
foods. J. Assoc. Off. Anal. Chem. 61:640-652.
005002074 Ruzicka, J.H.; Thomson, J.; Wheals, B.B.; Moods, N.F.
1968. The application of gel chromatography to
the separation of pesticides. Part I. organophos-
phorus pesticides. J. Chromatog. 34(1):14-20.
GS0019-002 Sittig, M. 1971. Agricultural chemicals manufacture.
Noyes Data Corp., Park Ridge, N.J.
GS0019-003 Sittig, M. 1977. Pesticides process encyclopedia.
Noyes Data Corp., Park Ridge, N.J.
GS0019-004 Stauffer Chemical Company. 1968. Aspon insecticide,
technical information bulletin. New York, N.Y.
GS0019-005 Stauffer Chemical Company. 1970. Infrared procedure
to determine the assay of Aspon, method no. MPO 25-3,
New York, N.Y. (Unpublished).
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting Registrations Under the Standard
Product Chemistry
MRID CITATION
005004479 Toy, A.D.F. 1951. Tetraethyl dithionopyrophosphate
and related tetraaalkyl dithionopyrophosphates.
J. Amer. Che. Soc. 73:4670-4674.
GS0019-006 U.S. Patent No. 2,663,722. 1953. Method of preparing
tetraalkyl dithionopyrophosphate.
Toxicology
000004858 Bullock, C.H. 1970. Toxicology lab report—T 1520;
T 1549. (Unpublished study received Apr. 18,
1978 under 239-2032; prepared by Stauffer Chem-
ical Co., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:234497-C).
000004861 Bullock, C.H. 1976. The eye irritation potential
of CC 7187: S-972; SOCAL 937/27:76. (Unpublished
study received Apr. 18, 1978 under 239-2032; sub-
mitted by Chevron Chemical Co., Richmond, Calif.;
CDL:234497-F).
000004835 Bullock, C.H.; Narcisse, J.K. 1974. The eye irri-
tation potential of Ortho Chinch Bug Spray (CC
5109): S-668: SOCAL 588/XX:24. (Unpublished
study received Aug. 5, 1974 under 239-765; sub-
mitted by Chevron Chemical Co., Richmond, Calif.;
CDL:022718-A).
000004857 Eisenlord, G.H. 1978. The acute oral toxicity of
Ortho Chinch Bug and Sod Webworm Control: S-1178;
SOCAL 1179/31:116. (Unpublished study received
Apr. 18, 1978 under 239-2032; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:234497-B).
000004859 Eisenlord, G.H. 1978. The skin irritation poten-
tial of Ortho Chinch Bug and Sod Webworm Control:
S-1179; SOCAL 1180/30:132. (Unpublished study
received Apr. 18, 1978 under 239-2032; submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:234497-D)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting Registrations Under the Standard
Toxicology
MRID
CITATION
000004833 Gregory/ L.K.; Narcisse, J.K. 1974. The eye irri-
tation potential of CC-5495: S-745; SOCAL
674/XX:117. (Unpublished study received June 25,
1975 under 239-765; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:220001-C).
000004836 Narcisse, J.K. 1972. Eye irritation potential of
Ortho Bug Spray: S-362; SOCAL 283/71:114. (Un-
published study received Nov. 14, 1974 under
239-765; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:051023-A).
000004837 Narcisse, J.K. 1972. Skin irritation potential of
Ortho Chinch Bug Spray: S-363; SOCAL 284B/VT:114.
(Unpublished study received Nov. 14, 1974 under
239-765; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:051023-B).
000004838 Rittenhouse, J.R.; Narcisse, J.K. 1972. The acute
dermal toxicity of Ortho Chinch Bug Spray: S-363;
SOCAL 284A/VT:117. (Unpublished study received
Nov. 14, 1974 under 239-765; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:051023-C).
Ecological Effects
GS0019-007 EPA. 1975. Report on the toxicity of technical
Aspon to rainbow trout. (U.S. EPA, Chemical
and Biological Investigations Branch, Belts-
ville, Maryland, Static jar test No. 913,
unpublished report.)
GS0019-008 EPA.
1976. Report on the toxicity of Aspon tech-
nical to rainbow trout. (U.S. EPA, Chemical
and Biological Investigations Branch, Belts-
ville, Maryland, Static jar test No. 932,
unpublished.)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting Registrations Under the Standard
Ecological Effects
MRID CITATION
GS0019-009 EPA. 1976. Report on the toxicity of Aspon
technical to bluegill sunfish. (U.S. EPA,
Chemical and Biological Investigations Branch,
Beltsville, Maryland, Static jar test No. 998,
7/14/76, unpublished report.)
000004831 Fink, R.; Reno, F.E. 1976. Final report: eight-
day dietary LC-50—bobwhite quail: project no.
132-129. (Unpublished study received March 8,
1976 under 476-2163; prepared by Hazleton Labor-
atories America, Inc. in cooperation with Mary-
land Dept. of Agriculture, Div. of Inspection and
Regulation, submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:225231-A).
GS0019-010 Hill, E.F.; Heath, R.G.; Spann, J.W.; Williams, J.D.
1975. Lethal dietary toxicities of environmental
pollutants to birds. Special Scientific Report—
Wildlife No. 191. U.S. Fish and Wildlife Service,
Washington, D.C.
000004830 Joiner, R.L. 1975. Safety evaluation of Aspon tech-
nical by a five-day feeding test in mallard ducks:
T-5397. (Unpublished study received June 26, 1975
under 476-2163; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:223289-A).
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting Registrations Under the Standard
Toxicology - Addenda
MRID CITATION
GS0019-019 The Andersons [sic]. 1979. Primary eye irritation
study in the albino rabbit, primary skin irritation
study in the albino rabbit, acute dermal toxicity
study in the albino rabbit, acute oral toxicity study
in rats - Turf Care 20-4-10 with Benefin and chlor-
pyrifos. (Unpublished studies, received May 30,
1979, under 9198-37).
GS0019-020 Biesemeior, J. 1978. Toxicology lab report [acute
oral LD-50, acute dermal LD-50, skin irritation, eye
irritation] reference no. F-8649. (Unpublished study
received Apr. 24, 1979, under 538-156; prepared by
Raltech Scientific Services, Inc. [Warf Institute,
Madison, Wis.]; submitted by O.M. Scott & Sons, Marys-
ville, Ohio).
GS0019-021 O.M. Scott & Sons, Co. 1979. Acute oral toxicity,
acute dermal toxicity, primary eye irritation, primary
dermal irritation - Kwit and Western Lawn Insect
Control. (Unpublished studies received May 5, 1980,
under 538-69.)
GS0019-022 O.M. Scott & Sons, Co. 1979. Acute oral toxicity,
acute dermal toxicity, primary eye irritation, primary
dermal irritation - Western Lawn Insect Control Plus
Fertilizer. (Unpublished study received May 5, 1980,
under 538-94.)
GS0019-023 Raltech Scientific Services, Inc. 1980. Eye irrita-
tion, Lab report 760871. (Unpublshed study received
May 1, 1980 under 538-137; submitted by O.M. Scott &
Sons Co., Marysville, Ohio.)
GS0019-024 Thompson, G.W. 1980. The primary eye irritation study
of F6713. (Unpublished study received June 12, 1980,
under 538-72; prepared by Raltech Scientific Services,
Inc.; submitted by O.M. Scott & Sons, Marysville, Ohio.
Accession # 243155.)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting Registrations Under the Standard
Toxicology - Addenda
MRID CITATION
GS0019-025 Thompson, G.W. 1979. Toxicology lab report - F9348.
(Unpublished study received Nov. 6, 1979, under 538-160;
prepared by Raltech Scientific Services, Inc.; submitted
by O.M. Scott & Sons, Marysville, Ohio. Accession #
241350.)
GS0019-025 Thompson, G.W. 1980. Toxicology lab report (acute
oral LD-50, acute dermal LD-50, skin irritation and eye
irritation), lab report 765242. (Unpublished study
received March 24, 1980, under 538-163; prepared by
Raltech Scientific Services, Inc.; submitted by O.M.
Scott & Sons, Marysville, Ohio.)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Examined and Judged Inappropriate For
Use in Developing the Standard
MRID CITATION
005004090 Bagdon, R.E.; DuBois, K.P. 1955. Pharmacologic
effects of chlorthion, malathion and tetra-
propyl dithionopyrophosphate in mammals. Arch.
Inter. Phatmacod. Therap. Cin (2/3): 192-199.
000004829 Bresolin, P.M. 1975. Toxicology laboratory report
T-5284: Aspon technical. (Unpublished study
received Dec'. 5, 1975 under 476-2163; submitted
by Stauffer Chemical Co., Richmond, Calif.;
CDL:223288-A).
000004853 Chevron Chemical Company. 19??. Summary statement:
Ortho Chinch Bug and Sod Webworm Control. Sum-
mary of studies 222347-B through 222347-C. (Un-
published study received May 6f 1975 under
239-2032; CDL: 222347-A).
000004855 Chevron Chemical Company. 19??. Summary statement:
Ortho Sod Webvrorm Control. Summary of studies
222348-B through 222348-C. (Unpublished study
received Apr. 18, 1975 under 239-2389; CDL:222348-A)
000004841 Chevron Chemical Company. 19??. Summary table:
efficacy data at 3.7 Ib Ai/A (Aspon). (Unpub-
lished study received March 31, 1960 under 239-765;
CDL:222167-B) .
000004849 Chevron Chemical Company. 1971. Summary: Ortho
Sod Webworm Control. (Unpublished study includ-
ing OR 513 report nos. 378-1, 387-41, 621-37,
621-36, 623-07, 623-06, 504-23, received Dec. 20,
1971 under 239-2389; CDL:001557-A).
000004842 Chevron Chemical Company. 1974[?]. Sunmary state-
ment: Ortho Chinch Bug Spray. Summary of studies
2222170-B through 222170-C. (Unpublished study
received Apr. 24, 1975 under 239-765; CDL:222170-A).
000004854 Chevron Chemical Company. 1974. Aspon, Dursban.
(Unpublished study including report nos. 627.02,
627.27, 623.09-623.12, 504.23, 504.26, 366.10,
658.29, 657.35, 519.23, 748.20, 727-23, 519.30,
727.24, 727.30, 627.23, 627.24, received May 6,
1975 under 239-2032; CDL: 222347-C).
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Examined and Judged Inappropriate For
Use in Developing the Standard
MRID CITATION
000004832 Chevron Chemical Company. 1975. Summary statement.
Summary of study 220001-D. (Unpublished study
received June 25, 1975 under 239-765; CDL: 220001-A).
000004847 Chevron Chemical Company. 1975. Summary statement—
phytotoxicity: Ortho Chinch Bug Lawn Spray.
Summary of study 2288758-B. (Unpublished study
received Dec. 3, 1975 under 239-2445; CDL:228758-A).
000004845 Chevron Chemical Company. 1975. Summary statement -
phytotoxicity: Ortho Sod Webworm Lawn Spray.
Summary of study 228762-B. (Unpublished study
received Dec. 16, 1975 under 239-2446; CDL:228762-A)
000004850 Chevron Chemical Company. 1975. Summary statement:
Aspon. Summary of study 133068-C. (Unpublished
study received June 25, 1975 under 239-2389;
CDL:133068-A).
GS0019-011 EPA. 1975. Report on the toxicity of Ortho Sod
Webworm (13% active ingredient) to Daphnia magna.
(U.S. EPA, Chemical and Biological Investigations
Branch, Beltsville, Maryland, Static jar test No.
865, 8/21/75, unpublished.)
GS0019-012 EPA. 1975. Report on the toxicity of Ortho Sod-
Webworm 13% active ingredient to rainbow trout.
(U.S. EPA, Chemical and Biological Investigations
Branch, Beltsville, Maryland, Static jar test No.
848, 7/8/75, unpublished report.)
GS0019-013 EPA. 1975. Report on the toxicity of Ortho Chinch
Bug Control, 3.2% a.i., to bluegills. (U.S. EPA,
Beltsville, Maryland, Static jar test No. 876,
9/22/75, unpublished report.)
GS0019-014 EPA. 1975. Report on the toxicity of Ortho Chinch
Bug Control on bluegills. (U.S. EPA, Chemical
and Biological Investigations Branch, Beltsville,
Maryland, Static jar test No. 866, 8/21/75,
unpublished.)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Examined and Judged Inappropriate For
Use in Developing the Standard
MRID CITATION
000005003 Lindemann, R.H.; Massey, V.C.; Coltharp, J.L.;
Bryant, W.F. 1974. Product performance report:
OR-513 report no. 657-10. (Unpublished study
including OR report nos. 705-41, 748-21, 748-22,
705-25, 705-23 and 705-42, received June 25, 1975
under 239-2389; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL: 133068-C).
000004848 Pate, D.A. 1967. Ortho Chinch Bug Control with
fertilizer. (Unpublished study including OR-513
report nos. 238-40, 238-41, 237-20, 230-47, 234-5,
234-2, 230-26, 230-49, received May 6, 1968 under
239-2265; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:001512-A).
000005377 Radeleff, R.D.; Wbodard, G.T. 1957. The toxicity
of organic phosphorus insecticides to livestock.
J. Amer. Vet. Med. Assoc. 130(5): 215-216.
000004860 Rittenhouse, J.R. 1978. The acute inhalation
toxicity of Ortho Chinch Bug and Sod Webworm
Control: S-1180; SCCAL 1181/28:142. (Unpub-
lished study received Apr. 18, 1978 under 239-
2032; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:234497-E).
000004834 Sherman, M.; Chang, M.T.Y.; Herrick, R.B. 1969. Fly
control, chronic toxicity, and residues from feed-
ing propyl thiopyrophosphate to laying hens. J.
Econ. Entonol. 62(6):1494-1499.
005004694 Sherman, M; Ross, E.; Chang, M.T.Y. 1964. Acute and
subacute toxicity of several organophosphorus in-
secticides to chicks. Toxicol. Appl. Pharmacol.
6(2):147-153.
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MRID
GS0019-015
GS0019-016
GS0019-017
GS0019-018
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Standard Reference Material
CITATION
Chemline, Chemical Information on Line [Data base].
Bethesda, Md: National Library of Medicine.
March 1980.
EPA. 1976. EPA manual of chemical methods for
pesticides and devices. AOAC, Arlington,
Virginia.
EPA. 1979. Pesticide chemical use pattern profile
for Aspon. Washington, D.C. (Unpublished).
Martin, H.; Worthing, C.R., eds. 1977. Pesticide
index: basic information on the chemicals used
as active components of pesticides. 5th ed.
British Crop Protection Council, Wbrcestershire,
England.
Spencer, E.Y. 1973. Guide to the chemicals used in
crop protection. 6th ed. Canada Dept. of Agri-
culture, Ontario, Canada.
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Appendix A
Table 1. Required Toxlcity Category Warning Statements for Aspon^Products
(Exposure
I Route
I
I
T
I
iToxiclty Category I |Toxlcity Category II iToxiclty Category III iToxicity Category IV
ty Catego
If swallc
ty Categ
fatal I
I Oral*
[Fatal If swallowed. WashlMay be fatal if swal- -| Harmful ^fswallowed.
(throroughly with soap (lowed. Nash thoroughly (Mash thoroughly after
(and water after handling!with soap and water af- (handling.
(and before eating or |ter handling and before j
I smoking. j eating or smoking. |
(No precautionary state-
jmerit required.
I Dermal* (Fatal if absorbed I May be fatal if absorbed) Harmful If abosrbed
(through skin. Do not get)through skin. Do not get)through skin. Avoid
Jin eyes, on skin, or on j in eyes, on skin, or on (contact with skin, eyes,
(clothing. Wear protec- (clothing. Wear protec- (or clothing. Wash thor-
(tive clothing and rubberItlve clothing and rubberjoughly after handling.
(gloves. Wash thoroughly (gloves. Wash thoroughly
(after handling and be- (with soap and water af-
jfore eating or smoking, jter handling and before
(Remove contaminated (eating or smoking. Re-
jclothing and wash be fore (move contaminated cloth-
jreuse. (ing and wash before
I (reuse.
No precaautlonary state-
ment required.
(Inhalation* (Fatal If inhaled. Do notlMay be fatal It Inhaled.(Harmful If Inhaled.
(breathe dust (vapor or (Do not breathe dust (va-|Avoid breathing dust
(spray mist). Wear a masMpor or spray mist). Wear) (vapor or spray mist).
(or pesticide respirator (a mask or pesticide res-(Remove contaminated
.'jointly approved by the jpirator jointly approved)clothing and wash before
(Mining Enforcement and (by the Mining Enforce- (reuse. Keep container
(Safety Administration |merit and Safety Admlni- (closed when not in use.
((formerly the U.S. Bur- (stration (formerly the (Use only with adequate
jeau of Mines) and the (U.S. Bureau of Mines) (ventilation.
(National Institute for (and the National Insti-
lOccupational Safety and (tute for Occupational
(Health. Remove contami- (Safety and Health. Re-
(nated clothing and wash (move contaminated cloth-
jbefore reuse. (Ing and wash before
I (reuse.
No precautionary state-
ment required.
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Appendix A
Table 1. Required Toxlcity Category Warning Statements for AsporP'Products
(Exposure 1 1 1 1
Route 1 Toxlcity Category I iToxlclty Category II (Toxlclty Category III j Toxlcity Category IV
IRye effects (Corrosive. Causes eye (Causes eye Irritation. (Avoid contact with eyes
(damage. Harmful or fatallHarmful If swallowed. Dolor clothing. Wash thor-
jlf swallowed. Do not getfnot get In eyes or on joughly after handling.
jln eyes, or oh clothing. (clothing. Mash thorough- I
(Wear goggles, or face jly after handling. Re-
jshleld. Mash thoroughly (move contaminated cloth-l
(after handling. Remove (Ing and wash before re-
jcontamlnated clothing (use.
(and wash before reuse. I
Skin effectslCorroslve. Causes burns. (Causes skin Irritation. Avoid contact with skin
(Do not get on skin or on|Do not get on skin or on|or clothing. Hash thor-
jclothlng. Wear protec- (clothing. Wash tho rough- joughly after handling.
Itlve clothing and rubber |ly after handling. Re-
jgloves.l Wash thoroughly (move contamlned clothing)
(after handling. Remove .(and wash before reuse, j
(contaminated clothing I I
(and wash before reuse, j
(Signal Word 1 DANGER I WARNING CAUTION
INo precautionary
Intent required.
No precautionary
ment required.
state-
state-
CAUTION
* Any product which falls Into Toxlcity Category I for the oral, dermal, or Inhalation acute toxiclty categories
will be required to carry the word "Poison" on the label with a skull and crossbones.
1 The need for gloves must be determined on an Individual basis. Some products cause blistering If confined
under clothing.
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Appendix A
Table 2. Required First Aid Statements
1 Exposure 1 I 1 I
1 Route (Toxlcity Category I JToxlcity Category II JToxicity Category III JToxicity Category IV
lOral |IC swallowed: Drink 1 or 2
|g lasses of water and induce vomit-
ling by touching back of throat
(with finger. Do not give anything
(by mouth to an unconscious person.
(Get medical attention.
(For ECs with >10% petroleum dis-
jtillates; If the patient is uicon-
jsclous, maintain breathing and
(heart beat (CPR:cardiopulmonary
(resuscitation). Contact your local
(Posion Control Center, hospital,
(or physician immediately. If the
(patient is conscious. Induce votni-
jting (syrup of Ipecac; if not
(available, stimulate the back of
(throat with finger). Never give
(anything by mouth to an uncon-
jscious person!
Dermal (If on skin: Wash with plenty of
(soap and water.
Inhalation (If inhaled: Remove victim to fresh
jaTr. If not breathing, give arti-
jficial respiration, preferably
jmouth-to-mouth. Get medical at ten-
It Ion.
Same as for Toxicity Category I. (Same as for Toxiclty Category I. 1
For ECs with >10% petroleum dls- (For ECs with >10% petroleum dis-
tillates: If the patient is uncon-
sclous, maintain breathing and
heart beat (CPR:cardiopulmonary
resuscitation). Contact your local
Poison Control Center, hospital,
or physician immediately. [The.
question whether to Induce vomit-
ing will be determined on a case-
by case basis.]
Same as for Toxiclty Category I.
Same as for Toxicity Category I.
tillates; If the patient is uncon-|
scious, maintain breathing and
heart beat (CPR:cardiopulmonary
resuscitation). Contact your local
Poison Control Center, hospital,
or physician Immediately. [The
question whether to induce vomit-
ing will be determined on a case-
by case basis.]
No first aid statement
required.
For ECs with >10» petro-
leum distillates: If the
patient is unconscious,
maintain breathing and
heart beat (CPR:cardio-
pulmonary resuscita-
tion) . Contact your lo-
cal Poison Control Cen-
ter, hospital, or physi-
cian immediately. Do not
induce vomiting!
Same as for Toxicity Category I. |No first aid statement
(required.
Same as for Toxicity Category I.
No first aid statement
required.
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Appendix A
Table 2. Required First Aid Statements CONTINUED
(Exposure
I Route
iToxiclty Category I
fg°ry
Flush
I
iToxicity Category II
I
IToxicity Category III
Ity C.
skin
r
IToxicity Category IV
(Eye effects lit in eyes; Flush with water tor (Sane as for Category I, except
ITS minutes. Get medical attention.jomit Note to Physician.
(If swallowed: Drink promptly a
(Targe quantity of milk, egg
(whites, gelatin solution, or; If
(these are not available, drink
(large quantities of water. Avoid
(alcohol. NOTE TO*PHYSICIAN: Prob-
lable mucosal damage may contrain-
jdicate the use of gastric lavage.
|If on skin; Wash with plenty of |No first aid statement
jsoap and water. Get medical at- (required.
|tent Ion if irritation persists.
Skin effects|I£ on skin: Wash with water. Get
(medical attention.
(If swallowed: Drink promptly a
(Targe quantity of milk, egg
(whites, gelatin solution, or, if
(these are not available, drink
(large quantities of water. Avoid
(alcohol. NOTE TO PHYSICIAN: Prob-
lable mucosal damage may contraIn-
Idicate the use of gastric lavage.
Same as for Category I, except
omit Note to Physician.
(It on skin; Washwitn plenty of
jsoap and water. Get medical at-
|tentIon if irritation persists.
No first aid statement
required.
•U S GOVERNMENT PRINTING OFFICE: 1980 341-085/3045
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