&EPA
United States
Environmental Protection
Agency
Office of
Pesticide* and Toxic Substanc
Washington DC 20460
Pesticide*
February 1987
Guidance for the
Reregistration of
Pesticide Products
Containing Dodine
as the Active Ingredient
-------
GUIDANCE FOR THE
RE REGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
Dodecylguanidine acetate
(CAS Number 2439-10-3, OPP Pesticide Chemical Code 044301)
Dodecylguanidine hydrochloride
(CAS Number 13590-97-1, OPP Pesticide Chemical Code 044303)
Dodecylguanidine terephthalate
(CAS Number 19727-17-4, OPP Pesticide Chemical Code 044302)
AS THE ACTIVE INGREDIENT
CASE NUMBER: 0161
FEBRUARY 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
-------
TABLE OF CONTENTS
I. Introduction
II. Chemicals Covered by this Standard
A. Description of the Chemicals
B. Use Profile
III. EPA Assessment 8
A. Introduction
B. Science Findings
C. Tolerance Reassessment
IV. Regulatory Position and Rationale 15
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 25
VI. Requirement for Submission of Generic Data 28
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data ... 36
VIII. Requirement for Submission of Revised Labeling 37
IX. Instructions for Submission 38
A. Manufacturing use products (sole active)
B. Manufacturing use products (combination)
C. End use products
D. Intrastate products
E. Addresses
-------
APPENDICES
I. DATA
Guide to Tables 42
Table A
Table B
II. LABELING
Summary of label requirments and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements . . .
Storage Instructions .
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX
IV. BIBLIOGRAPHY
Guide to Bibliography
Bibliography ....
V. FORMS
EPA Form 8570-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8570-6 Certification of Attempt to Enter Into an
Agreement with Other Registrations for
Development of Data
EPA Form 8570- Formulator's Exemption Statement
EPA Form 8570-4 Product Specific Data Sheet
-------
I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
-------
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^/, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the-end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
I/ The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
-------
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
-------
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
-------
II. CHEMICALS COVERED BY THIS STANDARD
A. Description of the chemicals
The following chemicals are covered by this Registration
Standard:
Chemical Name: Dodecylguanidine Dodecylguanidine Dodecylguanidine
acetate
Common Name: Dodine
Brand Names: Doguadine
Tsitrex, Dodine
acetate,
Dodecylguanidine
monoacetate, CL 7521,
AC 5223, Cyprex,
Melprex, Carpene,
Curitan, Syllit,
Venturol, and
Vondodine
hydrochloride
(DGH)
None
Cytox 2013
CAS
Registry
Number:
EPA/OPP
Pesticide
Chemical
Code:
Empirical
Formula:
2439-10-3
044301
13590-97-1
044303
C13H3oN3Cl
terephthalate (DGT)
None
Durotex 7,487-A
19727-17-4
044302
Not Available
Description of Physical Characteristics of Chemical
Color: White Not Available Not Available
Not Available Not Available
Physical
State:
Crystals,
Slightly waxy
Melting
Point:
136°C
Not Available
Not Available
-------
Description of Physical Characteristics (Cont'd)
Solubility:
Dodecylguanidine
acetate
Dodecylguanidine Dodecylguanidine
hydrochloride terephthalate (DGT)
(DGH)
Soluble at 7-23%
in low molecular
weight alcohols
at room temperature.
Soluble in acids
and 0.06% soluble
in water at 25C.
Insoluble in most
other solvents.
Soluble in ethanol.
Not Available
Not Available
Molecular
Weight:
287.4
263.9
B. Use Profile
Not Available
Products containing dodecylguanidine acetate (dodine) were
first registered in 1956 for controlling major fungal diseases
on fruit and nut crops and on certain ornamental and shade
trees. Most of the total volume of dodine is used for treating
apple scab. However, dodine resistant apple scab has been
found where dodine has been in predominant use for about 10
years. In such cases, it is advantageous for the apple grower
to use an unrelated fungicide. In some areas dodine has been
used for an extended period without apparent resistance. In
these areas it is prudent to use a second fungicide for part
of the season to offset the likelihood of the apple scab
developing dodine resistance.
Significant volumes of dodine are also used on pears and
cherries. As with apple scab, the probability of developing
dodine resistant cherry leaf spot can be reduced by
incorporating additional fungicides into the pest management
program. Other registered agricultural sites for dodine are
black walnut, peaches, pecans, and strawberries. Although
there is a tolerance for dodine on spinach, there are no
products registered for use on this site. Dodine is also
registered for the ornamentals: flowering crabapple, sycamore,
and rose.
-------
Dodine is also registered for use at several industrial
aquatic sites. It is used as a slimicide to control bacteria,
fungi, and algae in air washer and cooling tower systems, oil
field water systems, and pulp and paper mill systems. In
addition to the slimicide uses, dodine is also registered as
an industrial preservative for metalworking cutting fluids,
oil recovery packer fluids and drilling muds, and paper
products.
Dodecylguanidine hydrochloride (DGH) and dodecylguanidine
terephthalate are chemically similar to dodine. Although DGH
is not registered for agricultural sites, it is registered for
the same industrial sites as dodine. DGT is registered as a
industrial preservative for non-clothing textiles.
Dodecylguanidine
acetate
Dodecylguanidine
hydrochloride (DGH)
(DGH)
Dodecylguanidine
terephthalate
(DGT)
Registered
Sites:
Fruit and
nut trees,
ornamentals,
industrial
aquatic sites,
pulp and paper
products
Industrial
aquatic sites
Industrial
preservative
Predominant
Use(s):
Apple trees
Industrial
biocide/
preservative
Non-clothing
textiles
Formulation
Types
Registered:
Wettable powder/
dust, soluble
concentrate/
liquid
Soluble
concentrate/
liquid
Soluble
concentrate/
liquid
Method(s) of
Application:
Foliar spray. Automatic pump,
Air blast spray, ,Drip Feed, pour
Dusting equip-
ment drawn by
tractor or truck,
Boom sprayer,
Aerial spray,
Automatic pump,
Drip Feed, Pour
Manual pour,
Conventional
padding equipment
-------
8
III. EPA ASSESSMENT
A. INTRODUCTION
EPA reviewed available data supporting registrations of
products containing dodine, dodecylguanidine hydrochloride
(DGH), and dodecylguanidine terephthalate(DGH). Consequently,
EPA has identified additional data needed to evaluate human
health and environmental risks associated with the uses of
products containing these active ingredients (AI). Registrants
must develop these data in "order to maintain current product
registrations or register new products containing dodine,
DGHf or DGT. The following table summarizes the disciplines
for which EPA has identified data gaps. In Appendix A,
refer to Tables A-l and B-l (dodine), A-2 and B-2 (DGH), A-3
and B-3 (DGT) for required studies specific to these AIs.
Note that the toxicological studies evaluated in this
standard were all performed on dodine, the acetate salt of
dodecylguanidine. Other than for acute effects, dodine and
DGH will be considered equivalent because the acetate and
hydrochloride anions are expected only to lead to differences
in degree of dissociation (i.e., separation into dodecylguanidine
and the anions). Also, because the guanidine moiety is common
to both salts, and the anions are not expected to behave very
differently, no dramatic qualitative or quantitative differences
in toxicological properties are expected. Therefore, EPA will
consider the subchronic and chronic data submitted for dodine
to be applicable to DGH.
Because of the more complex nature of the terephthalate
anion, a subchronic oral rodent study will be required for
comparison with the current data on dodine to ascertain whether
qualitatively or quantitatively different effects result. If
the results show significant differences, EPA may require further
testing of DGT.
-------
B. SCIENCE FINDINGS
1. Dodine
Product and residue chemistry - Available product chemistry
data are limited to some product identity and disclosure of
ingredients. There are adequate methods available to determine
dodine residues in or on plant commodities. There are adequate
data to support the established tolerances for dodine in or on
spinach, apples, and pears. Tolerances and residues are further
described in Section III. C (Tolerance Reassessment).
Environmental fate - There are no available data allowing
EPA to assess the environmental fate of dodine. Similarly, EPA
lacks data pertaining to the potential groundwater contamination
from dodine use.
Ecological effects - EPA does not have data describing
toxicity of technical grade dodine to birds or aquatic
organisms. However, data on a formulation containing 95%
dodine as well as other active ingredients indicate that dodine
is slightly toxic to birds and highly toxic to freshwater
fish. A laboratory acute contact study indicates that dodine
is relatively nontoxic to honey bees. Based on the incomplete
data base, terrestrial dodine food residues pose no apparent
acute hazards to any avian or aquatic species that are Federally
designated threatened or endangered.
EPA lacks data regarding the acute oral toxicity of
technical grade dodine to birds. However, subacute oral
studies indicate a dietary LCso greater than 5000 ppm. EPA
cannot fully assess subacute toxicity unless data quantifying
percent AI is submitted. Although the incomplete data base on
technical dodine limits conclusions, available data from studies
using end-use products suggest that there would be no immediate
hazard to avian species resulting from exposure to terrestial
food crop residues. Studies using a typical formulated product
found the avian LD$Q ranged from 700 - 2000 ppm. Estimation
of residues to which birds will be exposed are approximately
70 to 170 ppm on leaves and 3-7 ppm on fruit.
-------
10
EPA calculated the estimated environmental concentration
(EEC) in aquatic systems based on assumptions of terrestrial
uses of dodine applied at maximum rates to fruit and nut trees
with subsequent runoff into a one acre pond. The EEC of 15
ppb is well below the toxic level to fish (650 to 870 ppb).
EPA cannot determine hazards to invertebrate species because
no data on either technical or formulated products are available.
In addition, EPA lacks data quantifying the concentration of
dodine in industrial effluents. Therefore, EPA needs monitoring
data to estimate the effects of discharge water on aquatic
biota.
Toxicology - The available data allow EPA to adequately
characterize the acute effects of dodine. The findings of
acute oral LDso of 1.46 g/kg, a one hour LC5Q of 1.05-1.79
mg/1, and no deaths among test animals after acute dermal
exposure to 2 g/kg indicate moderate lethal potency (Category
III). Severe irritation in both washed and unwashed eyes and
severe dermal irritation including erythema and edema were
seen in rabbits (Category I). Based on a 21-day skin sensiti-
zation study, there is no evidence of sensitization in humans.
There are no available studies on acute delayed neurotoxicity;
however, based on its structure, dodine would not be expected
to exhibit neurotoxic effects.
Although many of the available studies of dodine do not
satisfy EPA's data requirements, various effects of dodine can
be identified based on existing studies. Subchronic dietary
exposure of dogs caused changes in thyroid cells indicative of
stimulation (No Observed Effects Level (NOEL) = 1.25 mg/kg).
In another study, chronic dietary exposure in the rat caused
reduced weight gain in both sexes, accompanied by a comparable
reduction in food consumption in males (NOEL = 10 mg/kg).
EPA classifies this rat study as supplementary because the
-------
11
histopathology analysis was inadequate.^/ In a study of
reproductive effects, dietary exposure of parent mice caused
decreases in the number of pups per litter surviving until day
5 and weaning (Lowest Observed Effect Level (LOEL) = 74-89
mg/kg) this is also the lowest dose tested. The results of
an Ames assay for mutagenicity of 5 strains of bacteria with
and without metabolic activation were negative, i.e. no mutations
were observed.
2. DGH
Available product chemistry data are limited to some
product identity and disclosure of ingredients. There are no
data available describing environmental fate, ecological effects,
or toxicology. Data requirements are listed in Table A-2.
Note that for some studies, data on dodine will suffice for
DGH. In addition, some data requirements are reserved pending
results of initial studies to compare the similarity between
dodine and DGH.
3. DGT
Available product chemistry data are limited to some
product identity and disclosure of ingredients. There are
no data available describing environmental fate, ecological
effects, or toxicology. Data requirements are listed in
Table A-3. Note that some data requirements are reserved
pending results of initial studies to determine the
similarity between dodine and DGT.
I/ EPA classifies as supplementary studies that do not fully
meet specrfic regulatory data requirements but nonetheless
are considered by EPA to be scientifically sound and contain
useful information.
-------
12
C. TOLERANCE REASSESSMENT
Tolerances have been established for residues of dodine
in a variety of raw agricultural commodities, and meat, fat,
and meat byproducts (40 CFR 180.172). EPA has evaluated the
residue and toxicology data supporting tolerances to make
the following regulatory determinations:
"Whether the current tolerances and food additive regu-
lations are sufficient to cover the actual residues resulting
from use (including uses registered under FIFRA sec. 24(c)
and intrastate uses);
°Whether group tolerances can be established in accor-
dance with 40 CFR 180.34(£);
"Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are necessary;
and
°Whether the tolerances are expressed accurately and in
current terminology.
The regulatory determinations resulting from the EPA's
review are in Section IV.A., Regulatory Positions and Rationales.
1. Residue Data.
The residue data reviewed in support of these tolerances
include the following:
a. Data on the nature of the residues in plants, including
identification of major metabolites and degradates of
dodine. The metabolism of dodine in plants is not well
understood. Possible metabolites in apples include creatine
and guanidine. Tolerances are expressed in terms of the
parent compound, dodine per se. Similar studies are not
available for animals.
b. Radiolabeled studies on the uptake, translocation. and
metabolism of dodine in apples. These data are inadequate
to determine the uptake of dodine because the studies
were not conducted in accordance with label directions.
The study did show that limited translocation of dodine
from leaves to fruit occurs in apple trees.
c. Analytical methodology for determining the levels of
residues of dodine in plants. An adequate Gas-Liquid
Chromatography (GLC) method exists for enforcement and
analysis of residues. A colorimetric method has been
determined to be adequate for data collection, but is not
specific enough for enforcement purposes.
-------
13
d. Data on the levels of residues of dodine in individual
raw agricultural commodities. Data are not available
to adequately define the nature and levels of residues
in animals, feed commodities (currently only apple pomace)
or processed foods derived from raw agricultural commodities
2. Toxicology Data.
EPA calculated a Provisional Acceptable Daily Intake (PADI)
based upon the 12 month dog study. The NOEL from this study
was 1.25 mg/kg; at higher levels thyroid effects were noted. (
This dog study is considered only supplementary, and there are
significant data gaps for chronic, teratogenic, and oncogenic
effects. Therefore, EPA used a uncertainty factor of 1000
(rather than 100) to determine the PADI. Using these numbers,
the PADI is 1.25 mg/kg * 1000 or 0.0013 mg/kg. For a 60 kg
person, the Maximum Permissible Intake is 0.078 mg/day. The
maximum level of dodine residue that may theoretically be
available in the diet based on existing tolerances is 0.307
mg/day for a 60 kg person. The percentage of the PADI that
has been used for existing tolerances is 0.307 T 0.078 = 393.6%.
Although this result may suggest that persons consuming
dodine treated commodities are exposed to potentially harmful
levels of dodine, EPA does not believe that these theoretical
calculations are representative of actual dietary exposure.
Theoretical calculations such as these assume that (1) all
permitted crops are treated, (2) such treatments are made to
100% of each crop at the highest permitted dosage rate, and
(3) persons consume treated crops containing residues at the
maximum level. Each factor in the calculation assumes a
worst case exposure situation and thus tends to overestimate
the amount of dietary exposure to dodine. For example, EPA's
data on production of dodine suggest that it is highly unlikely
that 100% of the crops are treated at the maximum application
rate.
-------
14
EPA has no data from actual marketplace sampling by the
Food and Drug Administration for dodine residues. However,
experience with past sampling of commodities treated with
other pesticides indicated that actual residue levels are
generally well below the levels to which persons theoretically
might be exposed. In addition, the exposure calculation includes
spinach, as there is an established tolerance for this crop.
However, in practice, there should be no dodine residues on
spinach because there are no pesticide products containing
dodine that are registered for use on spinach.
3. Tolerances issued.
Tolerances for dodine in raw agricultural commodities
are listed in 40 CFR 180.172 and listed below. There are no
tolerances or food additive regulations for residues of dodine
in animal feeds or processed foods.
Crop Tolerance (ppm)
Apple 5.000
Cherries 5.000
Meat, including poultry 0.000
Milk and dairy products 0.000
Peaches 5.000
Pears 5.000
Pecans 0.300
Spinach 12.000
Strawberries 5.000
Walnuts 0.300
There are no Mexican tolerances for residues of dodine.
Codex MRLs and Canadian tolerances are listed below. Generally,
these levels are consistent with U.S. tolerances.
Codex Canadian
Apples and pears 5 ppm 5 ppm
Cherries 5 ppm 2 ppm
Peaches 5 ppm
Strawberries 5 ppm 5 ppm
-------
15
IV- REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS
EPA bases the following determinations on its review of
the available data bases for dodine, DGH, and DGT. These
regulatory decisions are subject to revision pending receipt
and review of the data by EPA. Details pertaining to scientific
findings are in Chapter III of this Registration Standard.
Further documentation is reported in the supplementary science
chapters for each discipline. Specific data requirements are
listed in the appended data tables.
1. Special Review - EPA will not at this time place
dodine, DGH, or DGT into Special Review.
Rationale; Based on available data, none of these
chemicals meets or exceeds the criteria for conducting
a Special Review (40 CFR Part 154.7).
2. Restricted use - EPA will not require restricted use
classification for end-use products containing dodine, DGH, or
DGT.
Rationale; Dodine is not highly toxic acutely via the
inhalation or oral routes. There are data demonstrating
that exposure to dodine can cause severe ocular and dermal
irritation. However, labeling provisions for protective
clothing will minimize acute risks from use of products
containing dodine.
3. Protective clothing - EPA has determined that in order
to meet the statutory standard for continued registration,
labels of products containing dodine, DGH and DGT must bear
language requiring the use of either protective clothing or
closed mixing - loading systems.
-------
16
Rationale; Results of acute toxicology studies indicate
that dodine causes severe eye and skin irritation. The
use of protective clothing, as specified in the labeling
section, or closed systems will reduce the potential risk
of skin and eye exposure resulting from mixing-loading,
application, and early reentry.
4. Endangered species - EPA will not require specific label
statements pertaining to the protection of Federally designated
threatened or endangered species.
Rationale; The available data for dodine do not suggest
that terrestrial food residues pose acute hazards to
threatened or endangered species in terrestrial or aquatic
systems.
5. Groundwater - EPA is not proposing a label advisory
statement regarding groundwater.
Rationale; There are, at present, no data suggesting cause
for groundwater concerns.
6. Spinach Tolerance - EPA will revoke, within one year
of issuance of this Standard, the spinach tolerance if no use
for a pesticide product on spinach is proposed.
Rationale; It is EPA's policy to discontinue residue
tolerances on crops for which there are no registered uses.
7. Meat and Milk Tolerances - EPA will revoke or replace
the zero tolerances with finite levels in meat and milk.
After registrants submit data on dodine residues in apple
pomace, EPA will establish any necessary tolerances and delete
the restriction against feeding apple pomace to livestock.
-------
17
Rationale; There should be no tolerances for dodine in
meat or mi lie if residues do not occur in feed items.
However, finite tolerances must be established in meat
and milk to reflect the probable consumption of feed
containing dodine residues. EPA considers the restriction
regarding apple pomace to be unenforceable due to the
impracticalities inherent in ascertaining that pomace
containing dodine, a relatively low-volume fungicide/ has
been used in livestock feed.
8. Reentry Interval - EPA is not imposing a reentry
interval for dodine at this time. However, EPA is requiring
a foliar dissipation study and a dermal exposure study to
assess hazard to farm workers reentering sites treated with
dodine. Protective equipment is also being required for
handlers and early reentry workers (see Unit IV for required
labeling).
Rationale; Available data indicate that dodine is a
severe eye and skin irritant. Some of the registered
uses of dodine, i.e., apples, strawberries, and cherries,
are prime hand-labor crops which require farmworkers
to come into direct contact with the pesticide. EPA is
concerned that workers may be exposed to residues of
dodine that may cause unreasonable adverse effects. In
1986 EPA received information on one poisoning incident
involving a 65% wettable powder solution of dodine mixed
with sulfur. In this incident, a crew of approximately
30-40 migrant farmworkers suffered eye and skin irritation
and headaches after picking cherries in an orchard that
had been sprayed one week earlier with a mixture of dodine
and sulfur. At least one worker required hospital emergency
room treatment. EPA, therefore, is requiring the following
studies to quantitatively determine appropriate reentry
-------
18
provisions: (1) foliar dissipation study to determine if
residues of dodine remain on the hand labor crops following
application of the pesticide, and (2) dermal exposure
study to determine the quantity of dodine to which workers
may be exposed after application of the pesticide.
Following receipt and review of these data, EPA will
develop a regulatory position on reentry as appropriate.
9. Glove Permeability Study - EPA is requiring a glove
permeability study for dodine.
Rationale; .Glove permeability data will enable EPA to
determine appropriate materials which are sufficiently
resistant to permeation or breakthrough of formulated
products containing dodine to provide reasonable protec-
tion to the hands.
10. Aquatic Residues - EPA is requiring aquatic residue
monitoring for dodine, DGH and DGT.
Rationale; The use of dodecylguanidine derivatives in
cooling towers and industrial processes will lead to discharges
into the aquatic environment. There are no models to estimate
the amount of dodecylguanidine derivatives to which aquatic
species will be exposed. Therefore, a residue monitoring field
study must be performed in order to quantify exposure levels.
11. New Uses - EPA will not allow any significant new
uses of dodine, DGH, or DGT until data gaps identified in this
Standard are filled.
Rationale; The available data are insufficient for EPA to
evaluate risks associated with the uses of these chemcials.
EPA finds that it is prudent not to permit significantly
expanded use of these chemicals until risks can be evaluated,
-------
19
12. Review of studies - EPA has identified those studies
the Agency will review immediately upon receipt of the data.
Other data will be reviewed when the Agency schedules a final
Registration Standard for dodine.
Rationale: Certain data are critical to EPA's determinations
regarding the risks involved with the uses of these chemicals
and the possibility that further studies must be initiated.
The following studies will receive immediate review.
40 CFR Part 158.125 Residue chemistry
171-4 Nature of metabolism in plants - dodine
40 CFR Part 158.135 Toxicology
82-1 90-day feeding - DGT
82-2 21-day dermal - dodine
83-1 Chronic toxicity, rodent and
non-rodent - dodine
83-2 Oncogenicity, 2 species - dodine
83-3 Teratogenicity, 2 species - dodine
83-4 Reproduction, 2 generation - dodine
40 CFR Part 158.145 Ecological effects
72-3 Oyster LC$Q - dodine, DGH, and DGT
72-7 Aquatic residue monitoring - dodine,
DGH, and DGT
40 CFR Part 158.140 Reentry Protection
132-1 Foliar Dissipation
133-3 Dermal Exposure
-------
20
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain dodecylguanidine acetate,
dodecylguanidine hydrochloride, or dodecylguanidine
terephthalate as the sole active ingredient, bear required
labeling, and conform to the product composition, acute
toxicity limits, and use pattern requirements listed in
this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain dodecylguanidine
acetate, dodecylguanidine hydrochloride, or dodecylguanidine
terephthalate as the sole active ingredient. Each MP formula-
tion proposed for registration must be fully described with
an appropriate certification of limits, stating maximum and
minimum amounts of the active ingredient and inert ingredients
which are present in products, as well as impurities found
at greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing dodecylguanidine
acetate, dodecylguanidine hydrochloride, or dodecylguanidine
terephthalate provided that the product labeling bears
appropriate precautionary statements for the acute toxicity
category in which each product is placed.
-------
21
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
registered for uses listed in Appendix III, EPA Index to
Pesticide Chemicals. This index lists all registered uses,
as well as approved maximum application rates and frequencies.
D. REQUIRED LABELING
All manufacturing-use and end-use products must bear
appropriate labeling as specified in 40 CFR 162.10. Appendix
II contains information on label requirements.
No pesticide product containing dodecylguanidine acetate,
dodecylguanidine hydrochloride, or dodecylguanidine terephthalate
may be released for shipment by the registrant after 28 February
1988, unless the product bears an amended label which complies
with the requirements of this Standard.
No pesticide product containing dodecylguanidine acetate,
dodecylguanidine hydrochloride, or dodecylguanidine terephthalate
may be distributed, sold, offered for sale, held for sale,
shipped, delivered for shipment, or received and (having so
received) delivered or offered to be delivered by any person
after 28 February 1989 unless the product bears an amended
label which complies with the requirements of this Standard.
In addition to the above, the following information must
appear on the labeling:
-------
22
1. Ingredients Statement
The ingredient statement for MPs must list the active
ingredient as: dodine, dodecylguanidine hydrochloride,
or dodecylguanidine terephthalate.
2. Use Pattern Statements
All manufacturing-use products must state that they
are intended for formulation into end-use products for
acceptable use patterns. Labeling must specify sites,
which are listed in Appendix III, Use Index. However,
no use may be included on the label where the registrant
fails to agree to comply with the data requirements in
TABLE A for that use pattern.
3. Precautionary Statements
a. Unless the product bears labeling requiring the
use of a closed mixing-loading system, a personal
protective equipment statement must appear on the
label for Manufacturing Use products and End Use
products. The statement must read for manufacturing-
use products:
PERSONAL PROTECTIVE EQUIPMENT
Pesticide Handlers; During mixing/loading or formulat-
ing of the concentrate, wear a long-sleeved shirt,
long-legged pants (or coveralls), chemical-resistant
apron, chemical resistant gloves, chemical-resistant
shoes, shoe covers, or boots, and goggles or face
shield.
-------
23
b. The statement must read for agricultural uses -
aerial and ground (airblast) applications - fruit
fungicide (liquid, dust, and other formulations applied
as sprays):
PERSONAL PROTECTIVE EQUIPMENT
Pesticide Handlers; During mixing/loading of the con-
centrate, wear a long-sleeved shirt, long-legged pants
(or coveralls), chemical-resistant gloves, chemical-
resistant shoes, shoe covers, or boots, chemical-
resistant apron, and goggles or face shield. During
application of the product, wear the same protective
clothing, except that a chemical-resistant hat with
a wide brim must be worn and the chemical-resistant
apron need not be worn. The applicator using an
enclosed tractor cab with positive pressure filtration
or an enclosed cockpit must wear long pants or
coveralls, long-sleeved shirt, socks and shoes.
During aerial application in a non-enclosed cockpit,
a helmet with a visor may be substituted for the
hat and goggles; chemical-resistant shoes, shoe
coverings, or boots may be omitted.
c. The statement must read for dust formulations -
agricultural uses:
PERSONAL PROTECTIVE EQUIPMENT
Pesticide Handlers; Mixer/loader/applicators must wear
long-sleeve shirt, long-legged pants (or coveralls), socks,
shoes, chemical-resistant gloves plus any existing label-
required protection.
d. For early re-entry for ail agricultural end-use products
the statement should read;
-------
24
EARLY REENTRY
Do not enter or allow entry into treated areas until[sprays
have dried/dusts have settled/vapors have dispersed, as
applicable] to perform hand labor tasks. Workers must
wear a long-sleeved shirt, long-legged pants (or coveralls),
chemical-resistant gloves, socks, and shoes for early
reentry into treated areas to perform other tasks before
[sprays have dried, dusts have settled, or vapors have
dispersed].
e. For industrial products all product (end-use) labels
must require chemical resistant gloves and face shield
(or goggles) when handling product.
f. All end-use products must have the following statement
about decontamination:
Wash thoroughly with soap and water after handling and
before eating, toileting, or smoking.
Remove and wash clothing before reuse. Launder clothing
separately from household articles. Replace gloves
frequently. Any clothing which has been drenched or
heavily contaminated and used gloves must be disposed
of in accordance with state or local regulations.
-------
25
V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling, or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing use or end use
product and whether the pesticide is the sole active ingredient
or one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing dodine, DGH, or DGT
as the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
y
2. The data requirements listed in Tables A and B .
I/ Data requirements are listed in the Tables in Appendix I
of this Registration Standard. The Guide to Tables in
that Appendix explains how to read the Tables. Table A
lists generic data requirements applicable to all products
containing the pesticide subject to this Registration
Standard. Table B lists product-specific data applicable to
manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
-------
26
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption, the
data requirements listed in Table
2/ Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data
for end use products at this time. Therefore, most
Registration Standards do not contain a Table C.
3/ If you purchase from another producer and use as the
source of your active ingredient only EPA-registered
products, you are eligible for the formulator's
exemption for generic data concerning that active
ingredient (Table A) and product-specific data for the
registered manufacturing use product you purchase
(Table B). Two circumstances nullify this exemption:
(1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
(2) If no product subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
-------
27
3. If not eligible for the formulator1s exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of multiple
active ingredients are subject to:
a. If not eligible for the formulator's exemption, the data
requirements listed in Tables A and C.
b. If eligible for the formulator's exemption/ the data
requirements listed in Table C.
-------
28
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.^/
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(.D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
4/ Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
-------
29
If you are not now eligible for a forraulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard/ you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What genericdata must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
-------
30
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting required data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
-------
31
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
data requirements;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an ag^reement^ to
jointlydevelopdata, jnit no other registrant has accepted
your offer. You request that EPA.not suspend your^registration
for non-compliance with the DC I• EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
-------
32
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terras to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(ill).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
-------
33
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed*
E. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timeframe
for submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocols.
F« Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
-------
34
the Product Manager listed at the end of this section and
k
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
in writing to the Office of Compliance Monitoring at the
address given in Section IX.E.
EPA will view failure to request an extension before
the response deadline as a waiver of any future claim that
there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline
for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. Time extensions
may be considered when joint data development is planned,
or when the Agency must approve a new or modified protocol
before the study can be begun.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
G. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
-------
35
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
-------
36
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data)
or IV.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
-------
37
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
-------
38
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing [name of
pesticide] as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.^/
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5/ If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified pro-
tocols for Agency review, you must submit a copy of the
Summary Sheet (and any supporting information) to the
Office of Compliance Monitoring, which will be monitoring
the data generated in response to this notice. This
submission is in addition to responding to the Product
Manager, and should be submitted to the Office of Compliance
Monitoring at the address given at the end of this section.
(Actual studies are not to be submitted to the Office of
Compliance Monitoring^)
-------
39
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing (name of pesticide)
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
-------
40
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within the time frames set forth in Table Ay you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing [name of pesticide] as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
-------
41
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a raockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing [name of pesticide] either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
John Lee, Product Manager 31
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
-------
42
TGUIDE-1
GUIDE TO TABLES
Table A contains generic data requirements that apply to
the specified AI in all products. This includes data require-
ments for which the test substance is a "typical formulation".
Table B present product-specific data requirements that apply
only to a manufacturing use product. The data tables are
generally organized according to the format outlined below.
1. Data Requirement (Column 1). The data requirements are
listed in the order of apperance in 40 CFR Part 158. The
reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines. The
Guidelines are available from the National Technical Information
(NTIS)f 5285 Port Royal Road, Springfield, VA 22161. Attn:
Order Desk, Phone 703-487-4650.
2. Test Substance (Column 2). This column lists the composition
of the required test substance as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
-------
43
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by other
registrants in accordance with data compensation requirements
of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
EPA may possess data on one of two required species, or
may .possess data on one test substance but not all. The
term may also indicate that the data available to EPA are
incomplete. In this case, when the data are clarified,
or additional details of the testing submitted by the
original data submitter, EPA may determined that the data
are acceptable. If this is the case, a footnote to the
table will usually say so.
NO_ - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner
that cannot be remedied by clarification or additional
information.
5. Bibliographic citation (Column 5). If EPA has acceptable
data in its files, this column lists the identifying number
of each study. This normally is the Master Record Identifi-
cation (MRID) number, but may be a GS number if no MRID number
has been assigned. Refer to the Bibliography Appendices for
a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that EPA has only partial data or no data, this
column will usually indicate YES. In some cases, even though
EPA does not have the data, EPA will not require its submission
because of the unique characteristics of the chemical, data on
another chemical can be used to fulfill the data requirement,
or the data requirement has been waived or reserved. Any such
unusual situations will be explained in a footnote to the
table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, then column 7 indicates when the data
are to be submitted. The time allowed is calculated based
on the issuance date of the Registration Standard. The time-
frames are those established either as a result of a previous
Data Call-in letter, or standardized timeframes established by
PR Notice 85-5 (August 22, 1985).
8« Footnotes (at the end of each table). Self-explanatory.
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data
§158
Requirement Test
Substance
.120 Product Chemistry
Use Does EPA Bibliographic
Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
Product Identity and Composition:
61-1
61-2
- Product Identity and TGAI
Disclosure of Ingredients
- Description of Beginning TGAI
Materials and Manufacturing
Process
V
All Yes Desk references
All Partially 00101353
00101403
00143591
No
2/
Yes
6 Months
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Limits TGAI
62-3 - Analytical Methods TGAI
Physical and Chemical
Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
All
Partially 00143591
All
All
All
No
No
Partially
00143591
All
All
No
No
3/
Yes
Yes
Yes
I/
6/
Yes
Yes
Yes
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data
§158.
Requirement
Test
Substance
Use
Patterns
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?
Time Frame
for
Submission
120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
-PH
- Storage Stability
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
All
All
All
All
All
All
All
All
All
All
No
No
No
No
Partially 00101362
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
Other Requirements:
64- 1 - Submittal of samples
TGAI
All
No
No
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
I/ Infonmtion obtained from the following desk references: Acceptable Common Names and Chemicals Names
for the Ingredient Statement on Pesticide Labels 4th Ed., 1979, p. 113 U.S. EPA, EPA-540/9-77-017;
Farm Chemicals Handbook, 1986, p. C 91 Meister Publishing Co., Willoughby, Ohio; Pesticide
Manufacturing and Toxic Materials Control Encyclopedia, 1980, Marshall Rittig (Ed.), Noyes Data Corp.
p. 354; The Pesticide Manual: A World Compendium, 7th ed.. Worthing and Walker (Eds.), British Crop
Protection Council, 1983, p. 229.
2/ The registrant must submit details of a manufacturing process, including the relative amounts of beginning
~~ materials, a description of the equipment used to produce the product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures, the name and address of the
manufacturer, producer or supplier of each beginning material used, and a copy of all available technical
specifications, data sheets, and other documents in which the manufacturer, producer, or supplier of the
beginning material describes its composition and properties.
3/ The registrant must provide a discussion of each impurity, including any N-nitroso compounds, believed to
be present at _>_ 0.1% (_>_ 1 ppm in the case of nitrosamines) based on knowledge of the beginning materials,
all possible chemical reactions and any contamination.
4/ Registrants must analyze 5 or more representative samples for the amount of AI and each impurity or
intentionally added inert ingredient present for which a certified limit is required (greater than 0.1%).
Validated analytical methods must be used.
5/ Upper and lower limits for dodine and for each intentionally added inert ingredient, and upper limits
for each impurity present at 0.1% (w/w) must be provided and certified. In the case of nitrosamines,
two samples of each product must be analyzed shortly after production, 3 months after production, and
6 months after production. Validated methods (sensitive to 1.0 ppm in the case of N-nitroso compounds)
must be used. An upper limit must be provided and certified for all N-nitroso compounds found.
6/ The registrant must submit quantitative methods to determine dodine (confirmatory). The method must be
accompanied by validation studies of the precision and accuracy of the method.
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINR
Data Requirement
§158.125 Residue Chemistry
171-4 - Nature of Residue
(metabolism)
o Plant •
o Livestock
171-4 - Residue Analy-
tical Method
Plant residues
Test
Substance
PAIRA
PAIRA and
Plant
Metabolites
TGAI and
Metabolites
Does EPA Bibliographic
Have Data? Citation
Partially 00058170
No
Partially 00034562 - 00090258
00089415 - 00101357
00094615 - 00101385
00101358 - 00101371
00101393 -
Must Additional
Data be
Submitted?
y
Yes
y
Reserved
3/
Yes
Time Frame
for
Submission
24 Months
12 Months
18 Months
Animal Residues
TGAI and
Metabolites
171-4 - Storage Stability PAI
No
No
Reserved
V
Yes
4/
24 Months
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data
171-4
Requirement
Magnitude of the residue
in plants
i/
Leafy vegetables group
I/
Spinach
8/
Pome fruits group
Apples
Test Does EPA Bibliographic Must Additional Time Ftame
Substance Have Data? Citation Data be for
Submitted? Submission
TEP Yes 00101371 - 00101373 No
9/
TEP Partially 00096154 - 00035127 Yes 12 Months
00089415
Pears TEP
Yes
00034562
No
Stone fruits groups
Cherries, sweet and sour TEP
Peaches TEP
Partially 00089417 - 00101357 Yes"
Partially 00090258 - 00093588 Yes
00101357
12/
24 Months
24 Months
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Time Frame
Data be for
Submitted? Submission
14/
Small fruits and berries group
Strawberries
16/
Tree nuts
Pecans
Walnuts
171-4 Magnitude of residues
in meat, milk, and poultry
TEP
Partially
TEP
TEP
TGAI or
plant
metabolites
Partially
No
No
00089881
00101358
15/
Yes
Yes
18/
No
Reserved
19/
24 Months
24 Months
18 Months
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
§158.125 Residue Chemistry - Footnotes
I/ Registrants must submit data depicting the uptake, distribution, and metabolism of [14C] dodine (radiolabeled
on the guanidine carbon) in apples and strawberries following foliar applications. The test compound must
be applied directly to developing fruit. Residues in mature plant parts must be identified and quantified.
Application rates must be sufficiently high to permit characterization of all of the radiolabeled residues.
Identification of all residues must be confirmed by analytical methods such as gas liquid chromatogaphy (GLC),
high pressure liquid chromatography (HPLC), and/or mass spectrometry. The solvent extraction efficiency of
dodine residues from mature plants must be determined. If the efficiency is low, further extraction using
hydrolysis techniques may be needed to release bound or conjugated residues. Representative samples must be
analyzed by enforcement methods to ascertain that all metabolites and impurities of concern are determined by
these methods.
2/ If residues of concern are found in apple pomace, registrants must submit metabolism studies utilizing
ruminants and poultry. Animals must be dosed for at least three days with guanidine-labeled [14C] dodine
at a concentration in the total diet that will result in sufficient residues for characterization in muscle,
fat, kidney, liver, and milk. Animals must be sacrificed within 24 hours of the final dosing. Milk must
be collected twice daily. Data depicting residue levels in eggs will not be required, since apple pomace
is not fed to laying hens. Representative samples must be analyzed by enforcement methods to ascertain
that all metabolites and impurities of concern are determined by these methods.
3/ Residues of dodine per se in or on crop samples must be analyzed by the multiresidue methods published as
an addendum to subdivision D of the Guidelines. Protocols for methods I, II, III, and IV are available
from National Technical Information Service (NTIS) Order No. PB 86 203734/AS.
4/ Residue analytical methods in animals are not presently required. However, if residues of concern are detected
in the animal metabolism studies, EPA may require analytical methods for dodine residues in animal products.
5/ Registrants must submit information on the intervals and conditions under which samples were stored to support
all established tolerances for residues of dodine; similar information must accompnay any new data generated
in response to this standard. These data must be accompanied by data depicting the percent decline in residues
at the time and under the conditions specified. On receipt of these data, EPA will reevaluate the adequacy of
the tolerances. These data must be accompanied by fortification recovery data depicting the stability of dodine
residue of concern in appropriate sample substrates under the conditions and for the time intervals specified.
It should be noted that the nature of the residue in plants and animals has not been adequately described.
Therefore, if the requested plant metabolism data reveal additional metabolites of toxicological concern, EPA
will require data reflecting the storage stability of those metabolites. Also, if residues of concern transfer
to animal commodities, EPA will require data depicting the stability of the residues of concern in animal product.
-------
_€/ If a crop group tolerance is desired, registrants should propose use directions and submit appropiate
supporting residue data for the additional representative group members head lettuce, leaf lettuce, and
celery.
7/ The submitted data adequately support the established tolerance under the proposed use directions and
limitations. No additional data will be required if any party proposes to register dodine for spinach.
If a use is not approved within a year of issuance of this Standard, the tolerance will be revoked.
8/ If a crop group tolerance is desired, registrants should submit data depicting dodine residues of concern
in or on pears after multiple foliar applications at 5-day intervals (as needed) throughout the growing
season as follows: (i) wettable powder applied aerially at 1.95 Ib Al/acre or 0.49 Ib AI/100 gal of spray
suspension with the last application made seven days before harvest (in OR tests must also include ULV
applications in 5-7 gal/acre); (ii) of a dust at 1.6 Ib M/acre with the last application made five days
before harvest; and (iii) of a dust at 2 Ib Al/acre with the last application made seven days before
harvest. Registrants should submit separate tests for. dusts using aerial and ground equipment. Registrants
should propose a maximum seasonal foliar application rate or a maximum number of foliar applications per
season.. Required studies must reflect these use limitations. Registrants should conduct tests in CA, OR,
and NY. These states collectively account for about 68% of U.S. pear production and are representative of
all the major U.S. production regions (Agricultural Statistics, 1985, p. 214).
9/ The available data adequately support the established tolerance for residues of dodine in or an apples.
However, EPA no longer considers the restriction against using dodine-treated apples for the manufacture
of the livestock feed apple pomace to be practical or enforceable. Therefore, registrants must submit
data depicting dodine residues of concern in wet and dry pomace and juice processed from apples bearing
measurable, weathered residues. Appropriate food/feed additive tolerances must be proposed if
concentration of residues occurs in processed products.
10/ The available data are insufficient to assess the adequacy of the established dodine residue tolerance
in or on pears. However, EPA will not require additional data because data translated from apples
adequately support the established tolerance for pears.
ll/ If registrants seek a crop group tolerance they must submit additional data to support the established
tolerance(s) for residues of dodine in or on the representative group members cherries and peaches.
Refer to the appropriate crop sections for details of data requirements. Registrants must propose use
directions and submit appropriate supporting residue data for the additional representative group member
plum/fresh prunes.
12/ Registrants must submit data depicting dodine residues of concern in or on sweet and sour cherries on
the same day following the last of several foliar applications (at 7 day intervals) of the 65% wettable
powder applied with aerial equipment at 1.3 Ib Al/acre. Registrants must submit separate tests for dust
formulations applied with aerial and ground equipment at 2.4 Ib Al/acre. Registrants must propose a
maximum seasonal applicatin rate or maximum number of applications per season and the required studies
must reflect these proposals. Tests must be conducted in CA, MI, and WA for sweet cherries, and MI and PA
for sour cherries. These states represent approximately 75% and 80%, of 1984 sweet and sour cherry producing
areas, respectively (j^ricultural Statistics, 1985, p. 194).
-------
13/ Registrants must submit data depicting dodine residues of concern in or on peaches following multiple foliar
applications (by ground and, in separate tests, aerial equipment) of a 65% wettable powder formulation at
0.325 Ib AI/100 gal or 1.3 Ib Al/acre. Foliar applications should begin at shuck split or, in western states,
when petals begin to open, and continued at 7-day intervals until 15 days prior to harvest. Tests must be
conducted in CA, GA, OR, and SC which collectively produce about 80% of the U.S. peach crop (Agricultural Statistics
1985, p. 211). The registrant must propose a maximum seasonal application rate or a maximum number of applications
per season and the required studies must reflect this number.
14/ If a crop group tolerance is desired, registrants should submit additional data to support the established
tolerance for residues of dodine in or on the representative group member strawberries. Refer to the strawberry
section for details of data requirements. Registrants should propose use directions and submit appropriate
supporting residue data for additional representative group members blueberries, blackberries, cranberries, and
grapes.
15_/ Registrants must submit data depicting dodine residues of concern in or on strawberries harvested 14 days
following multiple foliar applications (at 7-day intervals) of a dust or wettable powder formulation at
1.3 Ib Al/acre Registrants must conduct separate tests using ground and aerial equipment to apply a dust
and using aerial equipment to apply a wettable powder. Registrants must propose a maximum permissible
number of applications per season or a maximum Ib Al/acre/season rate. The required tests must reflect
the maximum seasonal rate proposed. Tests should be conducted in CA, FL, and NY, states which collectively
represent about 93% of 1984 U.S. strawberry producting areas (Agricultural Statistics, 1985, p. 221).
16/ If a crop group tolerance is desired, registrants should submit additional data to support the established
tolerance for residue of dodine in or on the representative group member, pecans. Refer to the pecans section
for details of data requirements. In addition, registrants should submit data depicting dodine residue of
concern in or on walnuts sampled following multiple foliar applications of the 65% wettable powder at 0.65 Ib
AI/100 gal or 2.6 Ib Al/acre applied at 10-day intervals by ground and aerial equipment, respectively in
separate tests. Tests must be conducted in CA which accounts for about 99% of U.S. English walnut production
(1982 Census of Agriculture, Vol. 1, Part 51, U.S. Dept. of Commerce, p. 368). The registrant must propose
a PHI and a maximum seasonal foliar application rate or maximum number of foliar applications per season.
The required studies must reflect these proposals. Use limitations proposed must be similar to pecans in order
for a crop group tolerance to be considered. Registrants should propose use directions and submit appropriate
supporting residue data for one additonal representative group member, almonds.
IT/ Registrants must submit data depicting dodine residues of concern in or on pecan nutmeats sampled following ^
multiple foliar applications of the 65% wettable powder (through shuck-split) at 4.55 Ib Al/acre or 0.65 Ib
AI/100 gal and 2.6 Ib Al/acre or 0.13 Ib AI/100 gal applied at 10-day intervals by ground and aerial equipment,
respectively, in separate tests. Registrants must conduct tests in GA, NM, and TX, states which represent about
73% of 1984 U.S. pecan production areas (Agricultural Statistics, 1985, p. 234). Registrants must propose a PHI
and a maximum seasonal foliar application rate or maximum number of foliar application per season. The required
studies must reflect these proposals.
18/ EPA does not have data to evaluate the established tolerance for dodine residues in or on walnuts. However,
EPA will not require data because the data requested for pecans can be translated to walnuts.
-------
19/ The nature of the residue in animals and animal products (including meats, milk, and poultry) is not adequately
understood. Currently there are no tolerances for residues of dodine in animal products. If residues of
concern are found in apple pomace, EPA will require livestock metabolism studies. On receipt of the data
requested in the section entitled "Nature of Residue in Livestock (Metabolism)," EPA will determine the necessity
for livestock (ruminant and poultry) feeding studies and, if appropriate, determine the adequacy of any proposals
for tolerances for residues in animal products.
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FDR DODINE
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Test
Substance
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
Use
Patterns
A,B,D
A,B,D
A
N/A
A,B
A
A,D
D
Does EPA Bibliographic
Have Data? Citation
No 00131135
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?
Yes
Yes
Yes
No_J/
Yes
Yes_2/
Yes
Yes
Time Frame
for
Submission
"9 Months
9 Months
9 Months
27 Months
27 Months
27 Months
27 Months
MOBILITY STUDIES:
163-1 - Leaching and
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA
TEP
TEP
A,B,D
No
No
No
Yes
Yes
Reserved 3 /
12 Months
12 Months
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data Requirement
§158.130 Environmental Fate -
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soilr Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Test
Substance
Continued
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
Use Does EPA Bibliographic
Patterns Have Data? Citation
A,B No
D No
\J No
4 /
No
!_/ No
\J No
A,D No
A,D No
D No
Must Additional
Data be
Submitted?
Yes
Yes
No _!/
No _!/
Reserved 5/
No _!/
No_l/
Yes
Yes
Yes
Time Frame
for
Submission
27 Months
27 Months
50 Months
39 Months
12 Months
12 Months
Organisms
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FDR DODINE
§158.130 Environmental Fate - Continued
I/ Not required for this AI due to the nature of the use patterns.
2/ Anaerobic aquatic metabolism may be substituted for these data.
3/ Reserved, depending on results of laboratory volatility tests.
4/ This RS for single AI pesticides only.
V Reserved, depending on results of field dissipation studies (164-1).
-------
TABLE A-l
GENERIC DATA
FOR DODINE
— -
Date
§158,
•»•»
Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted Submission
•135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Oral U>5o - Rat TGAI
- Dental LDso TSKL
- Inhalation LCso - Rat TGAI
- Eye Irritation - Rabbit TGAI
- Dermal Irritation - Rabbit TGAI
- Dental Sensitization - TGAI
Guinea Pig
- Delayed ' TGAI
Neurotoxicity - Hen
Yes 00124280 No
Yes 00124280 No
Yes 00070339 No
Yes 00124280 No
Yes 00124280 No
Yes 00157386 No
No No _!/
SUBCHRONIC TESTING:
82-1
- 90-Day Feeding: TGAI
- Rodent
. X*fr^»H — ^•<-»^3^">»% Ai nV^TV T
Yes 00082517 No 2/
Klf* XT—. •"» /
82-2 - 21-Day Dernal
TGAI
No
Yes
12 Months
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data
§158
82-3
82-4
82-5
Requirement Test
Substance
.135 Toxicology - Continued
- 90-Day Dental TGAI
- 90-Day Inhalation TGAI
- Rat
- 90-Day Neurotoxicity TGAI
Hen/Mammal
Use Does EPA Bibliographic
Patterns Have Data? Citation
No
No
No
Must Additional
Data be
Submitted?
Nb 3/
Nb 4/
Nb I/
Time Frame
for
Submission
CHRONIC TESTING:
83-1
83-2
83-3
83-4
- Chronic Toxicity -
2 species:
- Rodent, and TGAI
- Non-rodent TGAI
- Oncogenicity -
2 species:
- Rat (preferred), and TGAI
- Mouse (preferred) TGAI
- Teratogenicity -
2 species TGAI
- Reproduction TGAI
No
No
No
No-
No
Nb
Yes
Yes
Yes
Yes
Yes
Yes
50 Months
50 Months
50 Months
50 Months
15 Months
30 Months
2-generation
-------
TABLE A-l
GENERIC DATA
FOR DODINE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.135 Toxicology - Continued
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
TGAI
TGAI
TGAI
Yes
No
No
00101372
No
Yes
Yes
12 Months
12 Months
SPECIAL TESTING
85-1 - General Metabolism
PAI or PAIRA
No
Yes
24 Months
I/ Dodine, by virtue of its structure or known toxicity, does not require a delayed
neurotoxicity study.
2/ Since chronic studies in a rodent and non-rodent species are required, 90-day feeding studies are not required.
Subchronic level studies are necessary to set dosage levels for these chronic studies, but need not be
submitted to the Agency.
3/ Uses do not involve purposeful prolonged, or comparable dermal exposure.
4/ Repeated inhalation exposure at toxic concentrations is not expected.
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FDR DODINE
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
133-3 - Dermal Exposure
Test
Substance
TEP
TEP
Use
Pattern
A
A
Does EPA
Have Data?
No
No
Bibliographic
Citation
Must Additional
Data be
Submitted?
yes
yes
Time Frame
for
Submission
27 Months
27 Months
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data Requirement
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LDgg
71-2 - Avian Dietary LCso
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LCso
72-2 - Freshwater
Invertebrates LCso
Test
Substance
TGAI
TEP
TGAI
TGAI
TGAI
TEP
TGAI
TEP _5/
TGAI
TEP _5/
Use
Pattern
A,D
A
A,D
A
A
A
A,D
D_4/
A,D
D_4_/
Does EPA Bibliographic
Have Data? Citation
No
Partially 101397 _!/
Partially 106142 _2/
NO
No
No
No
Yes 101394 101395
No
No
Must Additional
Data be
Submitted?
Yes
No
Yes
No
Yes _3/
No
Yes
No
Yes
Yes
Time Frame
for
Submission
9 Months
9 Months
24 Months
9 Months
9 Months
9 Months
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data
§158
72-3
72-4
72-5
72-6
Requirement
.145 Wildlife and
Aquatic Organisms -
- Estuarine and
Marine Organism LCso
- Fish
- Shrimp
- Oyster
- Fish Early Life Stage
and Invertebrate Life
cycle
- Freshwater
- Estuarine
- Fish Life Cycle
- Aquatic Organism
Test
Substance
Continued
TGAI
TEP 5/
TGAI
TEP 5/
TGAI
TEP 5/
i
TGAI
TGAI
TGAI
TEP
Use
Pattern
D
D
D
D
D
D
D
D
D
D
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
NO
No
No
No
No
Must Additional
Data be
Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Reserved 6/
Reserved 6/
Reserved 7/
No
Time Frame
for
Submission
12" Months
12 Months
12 Months
12 Months
12 Months
12 Months
Accumulation
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data'Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
S158.145 Wildlife and
Aquatic Organisms - Continued
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TEP
No
Yes 8/
3 Months
(Protocol)
24 Months
I/ Study would be acceptable if age of birds were reported to be 16 weeks,
for presently registered uses.
However, no requirement exists
2/ Study may fulfill requirement if percent AI is reported.
3/ Test required because dodine can be applied multiple times during or before breeding season.
V Required to support uses in paper and pulp mills, cooling towers, and oil water systems.
5/ A typical end-use product would contain 10% of a dodecylguanidine compound.
_6/ EPA may require both fish and invertebrate studies to support paper and pulp mill, cooling tower,
and oil water system uses based on the results of the aquatic monitoring study.
7/ Reserved pending results of fish early life stage and invertebrate life cycle tests.
8/ Registrants must monitor dodine in industrial effluents and receiving waters where it is used in cooling towers,
~~ pulp and paper mills, and oil operations and where there is a likelihood of effluent discharge to aquatic ecosystems.
Based on relevant factors (i.e. geographic sites, amount AI used, etc.) registrants must develop acceptable protocols
within 3 months to sample a representative number of the above facilities. EPA is requiring this data to assess
effects of dodine to endangered aquatic species and chronic effects to aquatic biota. Registrants must consider the
following when developing protocol: (i) the samples should be analyzed for dodine, (ii) use of standard methods
(HPLC or mass spectraphotometry/gas chromatography(MSGC)) to measure dodine, (iii) sites selected for sampling
should be where dodine is currently being used and be representative of small and large facilities and/or volumes,
(iv) sites selected must also be presentative of a range in volume of the receiving waters and freshwater and
estuarine systems; (v) samples from receiving water should be taken before and after treatment, (vi) sampling should
be performed at regular intervals for a long enough period to account for such things as seasonal and use variations.
-------
TABLE A-l
GENERIC DATA REQUIREMENTS FOR DODINE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
^contact
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to
aquatic insects
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
thru TESTING - PREDATORS
143-3 AND PARASITES
TGAI
TEP
Reserved^/
TEP
A,B
A,B
Yes
No
00036935
No
No I/
A,B
No
No I/
Reserved3/
Reserved3/
Reserved3/
Reserved3/
I/ As data from the acute contact study indicate low toxicity, no further testing is required.
2/ Reserved pending development of test methodology.
3/ Beserved pending EPA decision as to whether the data requirement should be established.
-------
GENERIC DATA
TABLE A-2
FOR DODECYLGUANIDINE HYDROCHLORIDE
Data Requirement
Test Use Does FPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
S158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and TGAI
Disclosure of Ingredients
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
All Partially Desk reference"
All Partially
All No
Yes
Yes
Yes
6 Months
6 Months
6 Months
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
No
No
No
No
No
Yes
c
Yes~
e
Yes"
6/
Yes
Yes
12 Months
12 Months
12 Months
6 Months
6 Months
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE HYDROCHLORINE
Data Requirement
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Cctanol/water partition
coefficient
63-12 - pH
63-13 - Storage Stability
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
or PAI
PAI
PAI
PAI
TGAI
TGAI
Use
Patterns
All
All
All
All
All
All
All
All
All
All
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
No
Bibliographic Must Additional
Citation Data be
Submitted?
Yes
Yes
Yes
yes
Yes
yes
Yes
yes
Yes
Yes
Time Frame
for
Submission
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
6 Month
Other Requirements;
64- 1 - Submittal of samples
TGAI
All
No
No
-------
TABLE A-2
DATA REQUIREMENTS FOR DODECYLGUANIDINE HYDROCHLORIDE
I/ Information obtained from the following desk references: Acceptable Common Names and Chemicals Names
for the Ingredient Statement on Pesticide Labels 4th Ed., 1979, p. 113 U.S. EPA, EPA-540/9-77-017;
Farm Chemicals Handbook, 1986, p. C 91 Meister Publishing Co., Willoughby, Ohio; Pesticide
Manufacturing and Toxic Materials Control Encyclopedia, 1980, Marshall Sittig (Ed.), Noyes Data Corp.
p. 354; The Pesticide Manual: A World Compendium, 7th ed., Worthing and Walker (Eds.), -British Crop
Protection Council, 1983, p. 229.
2/ The registrant must submit details of a manufacturing process, including the relative amounts of beginning
materials, a description of the equipment used to produce the product, reaction conditions, the duration of
each step of the process purification procedures and quality control measures, the name and address of the
manufacturer, producer or supplier of each beginning material used, and a copy of all available technical
specifications, data sheets, and other documents in which the manufacturer, producer, or supplier of the
beginning material describes its composition and properties.
V The registrant must provide a discussion of each impurity, including any N-nitroso compounds, believed to
be present at > 0.1% (>_ 1 ppm in the case of nitrosamines) based on knowledge of the beginning materials,
all possible cKemical reactions and any contamination.
4/ Registrants must analyze 5 or more representative samples for the amount of AI and each impurity or
intentionally added inert ingredient present for which a certified limit is required (greater than 0.1%).
Validated analytical methods must be used.
5/ Upper and lower limits for dodine and for each intentionally added inert ingredient, and upper limits
for each impurity present at 0.1% (w/w) must be provided and certified. In the case of nitrosamines,
two samples of each product must be analyzed shortly after production, 3 months after production, and
6 months after production. Validated methods (sensitive to 1.0 ppm in the case of N-nitroso compounds)
must be used. An upper limit must be provided and certified for all N-nitroso compounds found.
6/ The registrant must submit quantitative methods to determine dodine (confirmatory). The method must be
accompanied by validation studies of the precision and accuracy of the method.
-------
GENERIC DATA
TABLE A - 2
FOR DODECYLGUANIDINE HYDROCHLORIDE
Data Requirement
§ 158.130 Envionmental Fate
DISSIPATION STUDIES LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Must
Test Use Does EPA Bibiographic Additional
Substance Patterns Have Data? Citation Data Be
Submitted
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
or PAIRA D
or PAIRA D No
or PAIRA I/ No
or PAIRA I/ No
or PAIRA I/ No
or PAIRA I/ No
or PAIRA D No
or PAIRA D No
Yes
Yes
No
No
No
No 2/
Yes
Yes
Time Frame
For
Submission
9 Months
-
9 Months
27 Months
12 Months
MOBILITY STUDIES:
163-1 - Leaching and
Adsorption/
Desorption
163-2 - Volatility (LAB)
163-3 - Volatility (Field)
TGAI or -PAIRA D
TEP I/
TEP I/
No
No
No
No
No
No
-------
TABLE A - 2
GENERIC DATA REQUIREMENTS FOR DODECTLGURNIDINE HYDRQCHLORIDE
Data Requirement
§ 158.1:
JU Envioninentai fate — c
Test Use
Substance Patterns
bntinued
Must
Does EPA Bibiographic Additional Time Frame
Have Data? Citation Data Be For
Submitted Submission
DISSIPATION STUDIES FIELD:
165-1
164-2
164-3
164-4
165-5
- Soil
- Aquatic (Sediment)
- Forestry
- Conibination and
Tank Mixes
- Soil, Long-term
TEP
TEP
TEP
TEP
V
D
I/
I/
!/
No
No
No
No
No
Yes
No I/
No 3/
No
27 Months
ACCUMULATION STUDIES:
165-1
165-2
165-3
165-4
165-5
- Rotational Crops
(Confined)
- Rotational Crops
(Field)
- Irrigated Crops
- In Fish
- In Aquatic nontarget
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
I/
I/
D
D
D
No
No
No
No
No
No I/
No I/
Yes
Yes
Yes
39 Months
12 Months
12 Months
Organisms
-------
Table A-2
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE HYDROCHLORIDE
§158.130 Environmental Fate - Footnotes
I/ Not required for this AI due to the nature of the use patterns.
2/ Anaerobic aquatic metabolism may be substituted for these data.
3/ This RS for single AI pesticides only.
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE HYDROCHLORIDE
Date
§158
Requirement
.135 Toxicology
Test
Substance
Use Does EPA Bibliographic
Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Oral IJ>50 ~ ^a^-
- Dermal H>JO
- Inhalation LCso - Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensitization -
Guinea Pig
- Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No 4/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding:
- Rodent, and
- Non-rodent
TGAI
TGAI
Yes
No
00082517
No I/
Yes I/
18 Months
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FDR DODECYLGUANIDINE HYDROCHLORIDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.135 Toxicology - Continued
82-2 - 21-Day Dermal TGAI
82-3 - 90-Day Dermal TGAI
82-4 - 90-Day Inhalation TGAI
- Rat
82-5 - 90-Day Neurotoxicity TGAI
Hen/Mammal
No
No
No
No
V
Yes
V
No
I/
No
No
12 Months
CHRONIC TESTING;
83-1 - Chronic Toxicity -
2 species
- Rodent
- Non-rodent
83-2 - Oncogenicity -
2 species
- Rat (preferred)
- Mouse (preferred)
83-3 - Teratogenicity -
2 species
83-4 - Reproduction
2-generation
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
No
NO
NO
NO
NO
No
Yes
]
Yes"
]
Yes"
]
Yes"
I/
I/
Yes
I/
Yes
50 Months
50 Months
50 Months
50 Months
15 Months
39 Months
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FDR DODECYLGUANIDINE HYDROCHLORIDE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.135 Toxicology - Continued
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-4 - Other Mechanisms of
Mutagenicity
TGAI
TGAI
TGAI
Yes
No
No
00101372
No
Yes
Yes
I/
12 months
12 months
SPECIAL TESTING
85-1 - General Metabolism
PAI or PAIRA
No
Yes
I/
24 months
I/ EPA will consider data on dodine as equivalent for dodecylguanidine hydrochloride.
2/ Uses do not involve purposeful, prolonged, or comparable dermal exposure.
V Repeated inhalation exposure at toxic concentrations are not expected.
Dodecylguanidine hydrochloride, by virtue of its structure or known toxicity, does not require
a delayed neurotoxicity study.
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE HYDROCHLORIDE
Data Requirement
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LDso
71-2 - Avian Dietary LC5Q
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish l£$Q
72-2 - Freshwater
Invertebrates !£$Q
Test
Substance
TGAI
TGAI
TGAI
TGAI
TEP
TGAI
TEP4/
TGAI
TEP4/
Use
Pattern
D
D
D
D
D
D
D_3/
D
D3/
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?
NO JL/
Yes _!/
No
No
No
Yes2/
Yes
Yes
Yes
Time Frame
for
Submission
-
9 Months
9 Months
9 Months
9 Months
9 Months
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE HYDROCHLORIDE
Data
S158
72-3
72-4
72-5
72-6
Requirement
.145 Wildlife and
Aquatic Organisms -
Estuarine and
Marine Organisms IC$Q
- Fish
- Shrimp
- Oyster
- Fish Early Life Stage,
and Invertebrate Life
cycle
- Freshwater
- Estuarine
- Fish - Life-Cycle
- Aquatic Organism
Test
Substance
Continued
TGAI
TEP5/
TGAI
TEP5/
TGAI
TEP4/
TGAI
TGAI
TGAI
TEP
Use
Pattern
D
D3/
D
D3/
D
D3/
D
D
D
D
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?
ReservedS/
ReservedS/
ReservedS/
ReservedS/
Yes
Yes
Reserved6/
ReservedS/
Reserved7/
No
Time Frame
for
Submission
12 Months
12 Months
Accumulation
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE HYDROCHLORIDE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.145 Wildlife and
Aquatic Organisms - Continued
TEP
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
D
No
Yes 8/
24 Months
(protocol-
3 months)
I/ For an aquatic nonfood use, only a single dietary study, preferably on the mallard duck, is required.
2/ A single fish species is required. If the results indicate that DGH toxicity is significantly
different from dodine, the second species may be required.
3/ Required to support uses in paper and pulp mills, cooling towers, and oil water systems.
4/ The typical end-use product used should contain 10% DGH. Toxicity data using end products containing
10% dodine may be substituted.
5/ Studies on dodine will suffice unless the results of the oyster larvae study on DGH are an order of
magnitude different from the same study using dodine. The oyster larvae study will serve as the
comparitive estuarine organism since, unlike fish and shrimp, it is nonmobile after setting and the
larval stage is likely to be more sensitive than fingerling fish or juvenile shrimp.
6/ EPA may require both fish and invertebrate studies to support paper and pulp mill, cooling tower, and
oil water system uses pending the outcome of the aquatic monitoring study.
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE HYDROCHLORIDE
§158.145 Wildlife and Aquatic Organisms - Continued
7/ Reserved pending results of fish early life stage and invertebrate life cycle tests.
8/ Registrants must monitor DGH in industrial effluents and receiving waters where it is
used in cooling towers, pulp and paper mills, and oil operations and there is also a
likelihood of effluent discharges to aquatic ecosystems. Based on the relevant factors
(i.e. geographic sites, amount AI used, etc.) registrants must develop acceptable
protocols within 3 months to sample a representative number of the above facilities.
EPA is requiring this data to assess effect of DGH to endangered aquatic species and
chronic effects to aquatic biota. Registrants must consider the following requirments
when developing protocol: (i) the samples should be analyzed for DGH, (ii) use of
standard methods (i.e. HPLC or MSGC) to measure DGH, (iii) sites selected for sampling
should be where DGH is currently being used and be representative of small and large
facilities and/or volumes, iv) sites selected must also be representative of a range in
volume of the receiving waters and freshwater and estuarine systems, v) sampling should
be performed at regular intervals for a long enough period to account for such things
as seasonal and use variations.
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREPTHALATE
Data Requirement
Test Use Does EPA Have Bibiographic Must Additional Time Frame
Substance Patterns Data? Citation Data Be Submitted? For
_ Submission
158.120 Product Chemistry
Product Identity and
Composition:
61-1 - Product Identity TGAI
& Disclosure of
Ingredients
61-2 - Description of Beginning TGAI
Materials and Manufactur-
ing Process
61-3 - Discussion of Formation TGAI
of Impurities
Analysis and Certification of
All
All
All
No
No
No
Product Ingredients
62-1 - Preliminary Analysis
61-2 - Certification of Limits
62-3 - Analytical Methods
Physical and Chemical Charac-
teristics
TGAI
TGAI
TGAI
All
All
All
No
No
No
Yes
y
2/
Yes
Yes
I/
Yes
e
Yes"
(
Yes"
I/
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
63-2 - Color
TGAI
All
No
Yes
6 Months
-------
TABLE A-3
DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREPHTHALATE
Data Requirement
63-3 -
63-4 -
63-5 -
63-6 -
63-7 -
63-8 -
63-9 -
63-10 -
63-11 -
63-12 -
63-13 -
Physical State
Odor
Melting Point
Boiling Point
Density , Bulk Density,
or Specific Gravity
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Vfater Parti-
tion Coefficient
pH
Stability
Test Use Does EPA Have Bibiographic Must Additional Time Frame
Substance Patterns Data? Citation Data Be Submitted For
Submission
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
All
All
All
All
All
All
All
All
All
All
All
No
NO
No
No
No
No
NO
No
No
NO
NO
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
Other Requirements
64-1 - Submittal of samples
N/A
N/A
No
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREPHTHALATE
I/ The registrant must submit the empirical formula, the molecular weight, the identity of the producer of the
compound, and any names and code numbers by which dodecylguanidine terephthalate is identified.
2/ Registrants must submit data of the manufacturing process, including the relative amounts of beginning material
a description of the equipment used to produce the product, reaction conditions, the duration of each step of
the process, purification procedures and quality control measursures, the name and address of the manufacturer,
producer or supplier of each beginning material used, and a copy of all available technical specifications,
data sheets, and other documents in which the manufacturer, producer, or supplier of the beginning material
describes its composition and properties.
3/ The registrant must provide a discussion impurity, including any N-nitroso compounds, believe to be present
at ^ 0.1% (2, 1 ppm in the case of nitrosamines) based on knowledge of the beginning material, all possible
chemical reactions and any contamination.
4/ Registrants must analyze 5 or more representative samples for the amount of AI and each impurity or intentionally
added inert ingredient present for which a certified limit is required (greater than 0.1%). Validated
analytical methods must be used.
5/ Upper and lower limits for DGT and for each intentionally added ingredient, and upper limits for each impurity
present at 0.1% (w/w) must be provided and certified. In the case of nitrosamines, two samples of each
product must be analyzed shortly after production, 3 months after production and 6 months after production.
Validated methods (sensitive to to 1.0 ppm in the case of N-nitroso compounds must be used. An upper limit
must be provided and certified for all nitroso compounds found.
6/ The registrants must submit quantitative methods to determine DGH. The method must be accompanied
by validation studies of the precision and accuracy of the method.
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREPHTHALATE I/
Data Requirement
§158.130 Envionmental Fate
DISSIPATION STUDIES LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
Adsorption/
Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Must
Test Use Does EPA Bibiographic Additional Time Frame
Substance Patterns Have Data? Citation Data Be For
Submitted Submission
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
or PAIRA
or PAIRA
or PAIRA
or PAIRA
or PAIRA
or PAIRA
or PAIRA
or PAIRA
or PAIRA
No
No
NO
No
No
No
No
No
No
No
No
No
No
No
NO
No
No
No
No
No
No
No
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREPHTHALATE
Data Requirement
Must
Test Use Does EPA Bibiographic Additional Time Frame
Substance Patterns Have Data? Citation Data Be For
Submitted Submission
§ 158.130 Envionmental Fate - Continued
DISSIPATION STUDIES FIELD:
165-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
165-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic nontarget
Organisms
TEP No
TEP No
TEP No
_2/ No
TEP No
PAIRA No
TEP No
TEP No
TGAI or PAIRA No
TEP NO
No
NO
NO
NO
No
No
No
No
No
No
I/ EPA is not requiring environmental fate data for DGT because there are no outdoor use sites registered for
this chemical.
2/ This Standard is for single AI formulations only.
-------
GENERIC DATA
TABLE A-3
FOR DODECYLGUANIDINE TEREPHTHALATE
Date Requirement
§158.135 Toxicology
ACUTE TESTING:
81-1 - Oral LDso - Rat
81-2 - Dermal U)$Q
81-3 - Inhalation IC$Q - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
81-7 - Delayed
Neurotoxicity - Hen
SUBCHRONIC TESTING:
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use Does EPA Bibliographic
Patterns Have Data? Citation
No
No
No
No
No
No
No
Must Additional
Data be
'Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
No_l/
Time Frame
for
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
82-1 - 90-Day Feeding:
- Rodent, and
TGAI
No
Yes
15 Months
- Non-rodent
TGAI
No
Reserved 2/
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FDR DODECYLGUANIDINE TEREPHTHALATE
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.135 Toxicology - Continued
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation:
- Rat
82-5 - 90-Day Neurotoxicity:
Hen/Mammal
TGAI
TGAI
TGAI
No
NO
No
TGAI
NO
Reserved 2
No __3/
No _4/
No_V
CHRONIC TESTING;
83-1 - Chronic Toxicity -
2 species: TGAI
- Rodent, and
- Non-rodent TGAI
83-2 - Oncogenicity -
2 species: TGAI
- Rat (preferred), and
- Mouse (preferred) .TGAI
83-3 - Teratogenicity -
2 species: TGAI
83-4 - Reproduction TGAI
2-generation
No
NO
No
No
No
No
Reserved 2/
Reserved 2/
Reserved 2/
Reserved 2/
Reserved 2/
Reserved 2/
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREFHTHALATE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
S158.135 Toxicology - Continued
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-4 - Other Mechanisms of
Mutagenicity
TGAI
TGAI
TGAI
No
No
No
Reserved 2/
Reserved 2/
Reserved 2/
SPECIAL TESTING
85-1 - General Metabolism
PAI or PAIRA
No
Reserved 2/
I/ Dodecylguanidine terephthalate, by virtue of its structure or known toxicity, does not
require a delayed neurotoxicity study.
2/ Data requirement will be based on comparison of results of required studies to results
for dodine to determine if effects are comparable and if data on dodine can be considered
equivalent.
3/ Uses do not involve purposeful, prolonged, or comparable exposure.
4/ Repeated inhalation exposure at toxic concentrations are not expected.
-------
TABLE A-3
GENERIC DftTA REQUIREMENTS FOR DODECYLGUANIDINE TEREPHTHALATE
Data Requirement
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LDso
71-2 - Avian Dietary IC$Q
71-3 - Wild Mammal Testing
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish l£$Q
72-2 - Acute
Invertebrate I£$Q
Test
Substance
TGAI
TGAI
TGAI
TGAI
TEP
TGAI
TEP 4/
TGAI
TEP_4/
Use
Pattern
D
D
D
D
D
D
D_3/
D
D_3/
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?
No _!/
Yes JL/
No
No
No
Yes _2/
Yes
Yes
Yes
Time Frame
for
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREPHTHALATE
Data
§158
72-3
72-4
72-5
72-6
Requirement
.145 Wildlife and
Aquatic Organisms -
- Estuarine and
Marine Organism ££50
- Fish
- Shrimp
- Oyster
- Fish Early Life Stage
and Invertebrate Life
Cycle
- Freshwater
- Estuarine
- Fish - Life-Cycle
- Aquatic Organism
Test
Substance
Continued
TGAI
TEP 5/
TGAI
TEP 5/
TGAI
TEP 4/
f
TGAI
TGAI
TGAI
TEP
Use Does EPA Bibliographic
Pattern Have nata? Citation
D No
D_3/ No
D No
D __3/ No
D No
D _3/ No
D No
D No
D No
D No
Must Additional
Data be
Submitted?
Reserved _5/
Reserved 5/
Reserved 5/
Reserved 5/
Yes
Yes
Reserved 6/
Reserved 6/
Reserved 7/
No
Time Frame
for
Submission
12 Months
12 Months
Accumulation
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREPHTHALATE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.145 Wildlife and
Aquatic Organisms - Continued
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TEP
No
Yes _§/
24 Months
(protocol-
3 months)
I/ For an aquatic nonfood use, only a single dietary study, preferably on the mallard duckf is required.
2/ EPA is initially requiring testing on only a single fish species. If the study demonstrates that DOT
toxicity is significantly different from that of dodine, EPA may require testing on a second species.
3/ Required to support uses in paper and pulp mills, cooling towers, and oil water systems and uses that
may result in direct discharge of effluent containing pesticide residue.
4/ The typical end-use product used should contain 10% dodecylguanidine terephthalate.
5/ Studies on dodine will suffice unless the results of the 48 hour oyster larvae study on DGT are an
order of magnitude different from the same study using dodine. The oyster larvae study will serve
as the comparative estuarine organism since, unlike fish and shrimp, it is nonmobile after setting
and the larval stage is to be more sensitive than fingerling fish or juvenile shrimp.
6/ EPA may require both fish and invertebrate studies to support paper and pulp mill, cooling tower, and
oil water system uses pending the outcome of the monitoring study.
-------
TABLE A-3
GENERIC DATA REQUIREMENTS FOR DODECYLGUANIDINE TEREPHTHALATE
§158.145 Wildlife and Aquatic Organisms - Continued
7/ Reserved pending results of fish early life stage and invertebrate life cycle tests.
8/ Registrants must monitor DGT in industrial effluents and receiving waters where it is used as a
biocide in textile manufacturing and there is a likelihood of effluent discharges to aquatic
ecosystems. Based on relevant factors (i.e. geographic sites, amount AI used, etc.) registrants
must develop acceptable protocols within 3 months to sample a representative number of textile
facilities. EPA is requiring this data to assess effects of DGT to endangered aquatic species
and chronic effects to aquatic biota. Registrants must consider the following when developing
protocols; (i) the samples should be analyzed for DGT; (ii) use of standard methods (i.e. HPLC
or MSGC) to measure DGT, (iii) sites selected for sampling should be where DGT is currently
being used and be representative of small and large facilities an must also be representative of
a range in volume of the receiving waters and freshwater and estuarine systems; v) sampling
should be performed at regular intervals for a long enough period to account for such things
as seasonal and use variations.
-------
TABLE B-l
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DODINE
Data
§158
Requirement Test
Substance
.120 Product Chemistry
Use Does EPA Bibliographic
Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
Product Identity and Composition:
61-1
61-2
- Product Identity and MP
Disclosure of Ingredients
- Description of Beginning MP
Materials and Manufacturing
Process
I/
All Yes Desk references
All Partially 00101353
00101403
00143591
NO
Yes _2/
6 Months
61-3 - Discussion of Formation of
Impurities
MP
All
Partially 00143591
Yes 3/
6 Months
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods
MP
MP
MP
All
All
All
NO
NO
Partially 00143591
Yes _4_/
Yes _5/
Yes 6/
12 Months
12 Months
12 Months
Other Requirements;
64- 1 - Submittal of samples
MP
All
No
No
6 Months
-------
TABLE B-l
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DODINE
I/ Information obtained from the following desk references: Acceptable Common Names and Chemicals Names
for the Ingredient Statement on Pesticide Labels 4th Ed., 1979, p. 113 U.S. EPA, EPA-540/9-77-017;
Farm Chemicals Handbook, 1986, p. C 91 Meister Publishing Co., Willoughby, Ohio; Pesticide
Manufacturing and Toxic Materials Control Encyclopedia, 1980, Marshall Sittig (Ed.), Noyes Data Corp.
p. 354; The Pesticide Manual: A World Compendium, 7th ed., Worthing and Walker (Eds.), British Crop
Protection Council, 1983, p. 229.
2/ The registrant must submit details of a manufacturing process, including the relative amounts of beginning
materials, a description of the equipment used to produce the product, reaction conditions, the duration of
each step of the process purification procedures and quality control measures, the name and address of the
manufacturer, producer or supplier of each beginning material used, and a copy of all available technical
specifications, data sheets, and other documents in which the manufacturer, producer, or supplier of the
beginning material describes its composition and properties.
V The registrant must provide a discussion of each impurity, including any N-nitroso compounds, believed to
be present at > 0.1% (^ 1 ppm in the case of nitrosamines) based on knowledge of the beginning materials,
all possible cHemical reactions and any contamination.
4/ Registrants must analyze 5 or more representative samples for the amount of AI and each impurity or
intentionally added inert ingredient present for which a certified limit is required (greater than 0.1%).
Validated analytical methods must be used.
V Upper and lower limits for dodine and for each intentionally added inert ingredient, and upper limits
for each impurity present at 0.1% (w/w) must be provided and certified. In the case of nitrosamines,
two samples of each product must be analyzed shortly after production, 3 months after production, and
6 months after production. Validated methods (sensitive to 1.0 ppm in the case of N-nitroso compounds)
must be used. An upper limit must be provided and certified for all N-nitroso compounds found.
6/ The registrant must submit quantitative methods to determine dodine (confirmatory). The method must
be accompanied by validation studies of the precision and accuracy of the method.
-------
TABLE B-l
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DODINE
Date
§158
Requirement
.135 Toxicology
Test
Substance
Use
Patterns
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data be
Submitted
Time Frame
for
Submission
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
- Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation
Irritation - Rat
- Primary Eye Irritation
- Rabbit
- Primary Dermal
Irritation - Rabbit
- Dermal Sensitization -
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
Guinea Pig
-------
TABLE B-2
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING DODECYLGUINIDINE HYDROCHLORIDE
Data Requirement Test Use Does EPA Bibliographic
Substance Patterns Have Data Citation
§158.120 Product Chemistry
Product Identity and Composition:
I/
61-1 - Product Identity and MP All Partially Desk references
Disclosure of Ingredients
61-2 - Description of Beginning MP All Partially
Materials and Manufacturing
Process
61-3 - Discussion of Formation of MP All No
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis MP All No
63-2 - Certification of Limits MP All No
63-3 - Analytical Methods MP All No
Other Requirements:
Must AJditional
Data be
Submitted?
Yes
Yes _2/
Yes _3/
Yes _4/
Yes _5/
Yes _6/
Time Frame
for
Submission
6 Months
6 .Months
6 Months
12 Months
12 Months
12 Months
64-1 - Submittal of Samples
MP
ALL
No
No
6 Months
-------
TABLE B-2
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING DODECYLGUANIDINE HYDRQCHLORIDE
§158*120 Chemistry - Footnotes
\/ Information obtained from the following desk references: Acceptable Common Names and Chemicals Names
for the Ingredient Statement on Pesticide Labels 4th Ed., 1979, p. 113 U.S. EPA, EPA-540/9-77-017;
Farm Chemicals Handbook, 1986, p. C 91 Meister Publishing Co., Willoughby, Ohio; Pesticide
Manufacturing and Toxic Materials Control Encyclopedia, 1980, Marshall Sittig (Ed.), Noyes Data Corp.
p. 354; The Pesticide Manual: A World Compendium, 7th ed., Worthing and Walker (Eds.), British Crop
Protection Council, 1983, p. 229.
2/ The registrant must submit details of a manufacturing process, including the relative amounts of beginning
materials, a description of the equipment used to produce the product, reaction conditions, the duration of
each step of the process purification procedures and quality control measures, the name and address of the
manufacturer, producer or supplier of each beginning material used, and a copy of all available technical
specifications, data sheets, and other documents in which the manufacturer, producer, or supplier of the
beginning material describes its composition and properties.
V The registrant must provide a discussion of each impurity, including any N-nitroso compounds, believed to
be present at > 0.1% (^ 1 ppm in the case of nitrosamines) based on knowledge of the beginning materials,
all possible cKemical reactions and any contamination.
4/ Registrants must analyze 5 or more representative samples for the amount of AI and each impurity or
intentionally added inert ingredient present for which a certified limit is required (greater than 0.1%).
Validated analytical methods must be used.
5/ Upper and lower limits for dodine and for each intentionally added inert ingredient, and upper limits
for each impurity present at 0.1% (w/w) must be provided and certified. In the case of nitrosamines,
two samples of each product must be analyzed shortly after production, 3 months after production, and
6 months after production. Validated methods (sensitive to 1.0 ppm in the case of N-nitroso compounds)
must be used. An upper limit must be provided and certified for all N-nitroso compounds found.
6/ The registrant must submit quantitative methods to determine dodine (confirmatory). The method must
be accompanied by validation studies of the precision and accuracy of the method.
-------
TABLE B-2
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTTJRING USE PRODUCTS CONTAINING DODECYLGUANIDINE HYDROCHLORIDE
Data Requirement
Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted? Submission
§158.135 Toxicity
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity
- Rabbit
81-3 - Acute Inhalation Toxicity
- Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation - Rabbits
81-6 - Dermal Sensitization -
Guinea Pig
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
TABLE B-3
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING DODECYLGUANIDINE TEREPHTHALATE
Data Requirement
Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted Submission
§158.120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity and MP
Disclosure of Ingredients
61-2 - Description of Beginning MP
Materials and Manufac-
turing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of
All
All
All
No
No
No
Yes _!/
Yes _2/
Yes_3_/
6 Months
6 Months
Product Ingredients
62-1 -
62-2 -
Preliminary Analysis
Certification of Limits
MP
MP
All
All
No
No
Yes
Yes
JL/
5/
12 Months
12 Months
62-3 - Analytical Methods MP
Other Requirements
64-1 - Submittal of Samples MP
All
All
No
No
Yes _6/
No
12 Months
6 Months
-------
TABLE B-3
PRODUCT SPECIFIC DftTA REQUIREMENTS FDR MANUFACTURING USE PRODUCTS CONTAINING DODECYLGUANIDINE TEREPHTHALATE
I/ The registrant must submit the empirical formula, the molecular weight, the identity of the producer of
the compound and any names and code numbers by which dodecylgiianidine terephthalate is identified.
2/ The registrant must submit details of the manufacturing process, including the relative amounts of beginning
material a description of the equipment used to produce the product, reaction conditions, the duration of
each step of the process purification procedures and quality control measures, the name and address of the
manufacturer, producer or supplier of each beginning material used, and a copy of all available technical
specifications, data sheets, and other documents in which the manufacturer, producer, or supplier of the
beginning material describes its composition and properties.
V The registrant must provide a discussion of each impurity, including any N-nitroso compounds, believed to be
present at ^ 0.1% (>_l ppm in the case of of nitrosamines) based on knowledge of the beginning material, all
possible chemical reactions and any contamination.
4/ Registrants must analyze 5 or more representative samples for the amount of AI and each impurity intentionally
added inert ingredient present for which a certified limit is required (greater than 0.1%). Validated
analytical methods must be used.
5/ Iflpper and lower limits for DOT and for each intentionally added inert ingredient, and upper limits for each
impurity present at 0,1% (w/w) must be provided and certified. In the case of nitrosamines, two samples
of each products must be analyzed shortly after production, 3 months after production and 6 months
after production. Validated methods (sensitive to to 1.0 ppm in the case of N-nitroso compounds) must be
used. An upper limit must be provided and certified for all N-nitroso compounds found.
The registrants must submit quantitative methods to determine DOT. The method must be accompanied by
validation studies of the precision and accuracy of the method.
-------
TABLE B-3
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING DODECYLGUANIDINE TEPEPHTHALATE
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted Submission Submission
§158.135
Toxicology
ACUTE TESTING
81-1 -
81-2 -
-
81-3 -
_
81-4 -
81-5 -
81-6 -
Acute Oral Toxicity - Rat MP All No
Acute Dermal Toxicity MP All No
Rabbit
Acute Inhalation Toxicity MP All No
Rat
Primary Eye MP All No
Irritation - Rabbit
Primary Dermal MP All No
Irritation - Rabbit
Dermal Sens itizat ion - MP All No
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
Guinea Pig
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling* Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Itejn 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR I62.10(h)(l)(iii)l
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and. run
parallel to other type.
.May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
nEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front j>anel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word*
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs,
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or '
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type Statement
Non- aerosol p'roducts"
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reusedly dispose of in the same manner*
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse
similar wording)
(or
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
EPft Compendium of Acceptable Uses
DDDINE
TftBLE OF CONTENTS
Site Name Page
TERRESTRIAL FOOD CROP 3
(figricultural Crops) 3
TERRESTRIAL NONFOOD CROP 8
(Ornamental Plants and Forest Trees 6
RQUftTIC NONFOOD 9
(Oquatic Sites) 9
INDOOR 1£
Industrial Preservatives and fldditives 12.
ftpple 3
Black Walnut 5
Chery 5
Commercial and Industrial Recirculating Water
Cooling Systems 9
Flowering Crabapple 8
Metalworking Cutting Fluids 1£
Oil Field Water Systems 10
Oil Recovery Drilling Fluids 13
Paper and Paper Products 13
Peach 6
Pear 7
Pecan 7
Preservation of Pulp and Paper Mill Processing Chemicals,
ftdhesives, and Coatings 14
Pulp and Paper Mill Systems 11
Rose 8
Strawberry 8
Sycamore 8
Issued: 3-11-86 III-O443O1-X
Provisional Update: 5-07-87
-------
EPft Compendium of Acceptable Uses
CO44301 DODINE*
TYPE PESTICIDE: Fungicide, Antimicrobial, Algaecide
FORMULflTIQNS;
Tech (96.9%)
FI (75%, 95%)
D (1%, £%, 3%, 3.9%, 4%, 5%, 6%)
WP (££.5%, 65%)
WP/D (95%)
RTU (4.7%, 4.8%, 5%, 9%, 1O%, 0.79 Ib/gal or 1O%, 0.84 Ib/gal or
GENERAL WARNINGS AND LIMITATIONS; Dodine is compatible with common-
ly used fungicides, insecticides, and acaricides such as dimetho-
ate, diazinon, dinocap, ferbarn, phosmet, propargite, sulfurs,
zineb, and wettable powder formulations of azinphos-methyl, carbar-
yl, chlorbenside, dicofol, endosulfan, malathion, phospharnidon,
parathion, ryanodine, and slow breaking oils of 6O to 75 viscosity.
Compatibility should be checked prior to use with emulsifiable con-
centrate or flowable concentrate formulations. Dodine is not com-
patible with chlorobenzilate, Bordeaux mixture, fixed copper, chlor-
dimeform, lime or lime sulfur. Dodine— oil mixtures are compatible
with liquid concentrate and flowable concentrate formulations of
phosphate insecticides as are wettable powder formulations of para-
thion, azinphos— methyl, carbophenothion, and certain other insecti-
cides. Check compatibility prior to use. Dodine-oil mixtures are
not compatible with wettable powder formulations of malathion, car-
baryl, zineb, ferbam, and sulfurs. The 65 percent wettable powder
formulation may be applied in concentrate sprays except as noted.
Dusts may be applied by aircraft.
Do not graze cover crops in treated orchards.
Precautionary Statements. For agricultural uses - aerial and
ground (airblast) applications - fruit fungicide (liquid, dust, and
other formulations applied as sprays): During mixing/loading of
the concentrate, wear a long-sleeved shirt, long-legged pants (or
coveralls), chemical -resist ant gloves, chemical -resist ant shoes,
shoe covers, or boots, chemical— resistant apron, and goggles or
face shield. During application of the product, wear the same pro-
tective clothing, except that a chemical -resist ant hat with a wide
brim must be worn and the chemical-resistant apron need not be
worn. The applicator using an enclosed tractor cab with positive
pressure filtration or an enclosed cockpit must wear long pants or
coveralls, long-sleeved shirt, socks and shoes. During aerial ap-
plication in a non-enclosed cockpit, a helmet with a visor may be
substituted for the hat and goggles; chemical -resist ant shoes, shoe
coverings, or boots may be omitted.
"For dust formulations - agricultural usesi Mixer/loader/applica-
tors must wear long-sleeve shirt, long-legged pants (or coveralls),
socks, shoes, chemical -resist ant gloves plus any existing label-
req u i red prot ect i on.
Do not enter or allow »ntry into treated areas until Csprays have
dried/dusts have settled/vapors have dispersed, as applicable] to
perform hand labor tasks. Workers must wear a long-sleeved shirt,
*dodecylguanidine acetate
Issued: 3-11-B6 III-0443O1-1
Provisional Update! 5-O7-87
-------
EPA Compendium of Acceptable Uses
DODINE
GENERAL WARNINGS AND LIMITATIONS (continued)
long—legged pants (or coveralls), chemical-resistant gloves, socks,
and shoes for early reentry into treated areas to perform other
tasks before [sprays have dried, dusts have settled, or vapors have
d ispersedD.
Refer to Registration Guidance Package for further precautionary
statements.
Wear goggles or face shield and chemical resistant gloves when hand-
ling industrial formulations.
Observe all warnings and limitations for other active ingredients
on multiple active ingredient labels or in tank mixes.
Dosage rates are given in active ingredient.
Agricultural Crop Tolerances (other than those listed in the text):
Meat 0. 0 pprn
Milk O.0 ppm
Spinach 12.O ppm
Definition of Terms;
MAI - multiple active ingredient(s)
SLN - Special Local Needs (24-C)
Issued: 3-11-86 II-O4A301-£
-------
Site and Pest
EPA Compendium of Acceptable Uses
DODINE
Dosages and Tolerance. Use. Limitations
Formu1at i on(s)
/O4OO1AA
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Apple
FEAJVA6
Apple scab
(Venturia)
O.081-O. 49
Ib/lOO gal
or
0.65-1.95
Ib/ft
(65* WP)
OOO241-OOO51
or
0.6-2.0 Ib/A
(154, 2*, 3*,
4%, 6% D)
O07OO1-OO2O5
or
5 ppm
5 day preharvest interval through
0.49 pound per 10O gallons or 1.3
pounds per acre for wettable pow-
der or 1.6 pounds per acre for
dust formulations.
7 day preharvest interval through
1.95 to 2.O pounds per acre.
Do not use treated apples in the
manufacture of apple pomace for
use in livestock feeds.
May cause russetting on Golden
Delicious, Grime Golden, and
Rhode Island Greening apple varie-
ties. Freezing or neai—freezing
temperatures, particularly when
accompanied by slow-drying condi-
tions may injure apple fruit or
predispose the fruit to chemical
injury. Do not apply more than
1.3 pounds per acre (wettable pow-
der) immediately before, during,
or immediately after occurrence
of such conditions.
Delayed dormant and foliar appli-
cations. Protective schedule:
Using ground equipment, apply
O.16 to O.3£5 pound per 1OO gal-
lons or O.65 to 1.3 pounds per
acre of wettable powder at 5 to 7
day intervals or as needed from
prebloom through first cover.
Oply O.O81 to O.16 pound per 1OO
gallons or O.65 pound per acre in
subsequent cover sprays as need-
ed. May be applied in a delayed
dormant oil schedule at 0.65 to
Issued: 3-11-86
II-044301-3
-------
EPA Compendium of Acceptable Uses
DODINE
Site and Pest Dosages and Tolerance. Use. Limitations
Formu1at i on < s)
Apple (continued)
0.02-O.O25 1.3 pounds per acre with 2 gal-
Ib/mature Ions of 6O to 75 viscosity oil.
tree By aircraft, apply O.975 pound
(IX D) per acre in 5 to 7 gallons per
acre as above. Post infection
CMAIJ applicat ions; After an infection
O. 45 lb/5OO period has occurred, apply 0.49
gal pound per 1OO gallons or 1.95
(22.5% WP) pounds per acre (wettable powder)
or during or following a rain from
O.6^1.95 Ib/ft prebloorn through first cover, and
(2%, 3.9%, in later cover sprays as needed.
454, 5.2% D) While timing of the spray may
vary considerably depending upon
temperatures, it is recommended
that application be made within
36 hours from the beginning of
the rain or wet period which
caused the infectrion. Emergency
scab conditions; If leaf lesions
are visible during prebloom, thor-
oughly apply a dilute spray of
0.325 pound per 1OO gallons, re-
peat in 5 to 7 days then follow
protective schedule. If leaf
lesions are visible following
bloom, thoroughly apply a dilute
spray of O.325 pound per 1OO gal-
lons, repeat in 7 to 1O days then
follow protective schedule.
Apply dusts using ground equip-
ment or aircraft as above on a
protective schedule.
May be formulated with glyodin;
ferbarn and sulfur; par at hi on and
sulfur; or sulfur and captan.
Issued: 3-11-Bfi II-O44301-4
-------
Site anc! Pest
B1 s.c••<
EPfi Compendium of Acceptable Uses
DODINE
Dosases and Tolerance. Use. Limitations
Formu1ation(s)
O. 3 ppm
No preharvest interval through
O. 65 pound per 10O gallons or 2.6
pounds per acre.
Do not graze meat or dairy
animals in treated groves.
Hrcthracnose
(leaf spot)
(Gnomonia)
Cherry
IBAQMCB
FMBCCDJ
Brown rot
blossom blight
(Moni1inia)
Cherry leaf
spot
(Coccornyces)
0.65 Ib/lOO
gal
or
a.6 Ib/ft
(65* WP)
0.325 lb/100
gal
or
1.3 Ib/A
(65* WP)
0.16-0.325
Ib/lOO gal
or
O.65-1.3 Ib/A
(65* WP)
or
O. S-£. 4 Ib/A
(3'/, 4*, 6%
D)
[MOID
O.45 1b/50O
gal
(££.5% WP)
or
O. 8-1.2 Ib/A
D)
Delayed dormant and foliar appli-
cations. Apply when first leaves
unfold. Repeat at 1O to 14 day
intervals.
5 ppm (sour and sweet)
No preharvest interval through
O.325 pound per 1OO gallons or
1.3 pounds per acre for wettable
powder or 2. 5 pounds per acre for
dust formulations.
Application when temperatures and
humidity are excessively high may
cause spotting to foliage or
fruit.
Use limited to western states.
Foliar application. Apply when
petals begin to open. Repeat at
full bloom and again at petal
fall.
Foliar and postharvest
applications. Apply at petal
fall or when first leaves
unfold. Repeat at 7 to 1O day
intervals and continue through
harvest if conditions favor leaf
spot. Apply immediately after
harvest and as needed.
May be formulated with glydoin;
or parathion and sulfur.
Issued: 3-11-86
II-O44301-5
-------
EPfi Compendium of Acceptable Uses
DDDINE
Site and Pest
Peach
Dosages and Tolerance.
Forrnulat i on (s)
Use
Limitati ons
FMCBXAfl
Bacterial spot
(Xant hornonas)
1.3 Ib/ft
or
0.325 lb/100
gal
WP)
FBflDMCB
Brown rot
blossom blignt
(Mon i1i n i a)
Leaf curl
(Taphrina)
0.3£5 lb/100
gal
or
1.3 Ib/ft
(6554 WP)
0.65-1.3 lb/
100 gal
or
£.6 Ib/ft
(65* WP)
5 ppm
Do not apply after delayed dor-
mant through 1.3 pounds per 10O
gallons or £.6 pounds per acre,
or after petal fall through O.325
pound per 1OO gallons or 1.3
pounds per acre in western
states.
15 day preharvest interval
through 1.3 pounds per acre for
tank mix with captan.
Foliar application. Tank mix
with captan (£.O pound active
ingredient captan per acre or O.5
pound per 1OO gallons). Under
light to moderate disease condi-
tions, apply at shuck split and
repeat at 7 to 1O day intervals
through the cover sprays. Do not
use concentrate sprays higher
than 3X. Do not combine with
solvent formulations of insecti-
cides or sulfur. Spray injury
may result if the tank mix is
applied with, immediately before,
or closely after an oil or zinc
sulfate-1 irne spray.
Use limited to western states.
Foliar application. Apply when
petals begin to open. Repeat at
full bloom and again at petal
fall.
Use limited to western states.
Dormant and delayed dormant ap-
plications. Apply high rate just
before buds swell in the spring.
If leaf curl was moderate to
sever the previous season, apply
1 month before buds swell in the
spring and again just prior to
bud swell.
Issued: 3-11-86
I1-044301-6
-------
Compendium of Acceptable Uses
DODINE
/04003ftft
Site and Pest
Pear
FEftJVftG
Pear scab
(Venturia)
/03O08fift
Pecan
FMBCCBm
FMftSMCO
FCADMCO
FMBDBfiT
FEOJCCV
Dosages and
Formalat ion(«
0. 325-0. 49
Ib/lOO gal
or
1.3-1.95 Ib/ft
(6554 WP)
OO0241-OO051
or
O. 75-£. 0 Ib/fl
(£56, 3%, 4X,
&y. D)
Brown leaf spot
(Cercospora)
Downy leaf spot
(Mycos ph aere1 —
la)
i_eaf blotch
(Mycosphaerel-
la)
Liver spot
(Gnomoni a)
Pecan scab
(Cladospori urn)
O. S-l.£ Ib/fi
(4* D)
CSLN:
up to 1.3
Ib/ft
WP)
O.3£5-0.65
lb/100 gal
[max 7OO
gal/ft}
or
1.3-2.6 Ib/fi
WP)
Tolerance. Use. Limitations
5 ppm
5 day preharvest interval through
1.6 pounds per acre as a dust.
7 day preharvest interval through
0.49 pound per 10O gallons or
1.95 to £.O pounds per acre.
Delayed dormant and foliar appli-
cations, ftpply at 5 to 7 day
intervals or as needed from pre-
bloorn through petal fall again in
first cover. Repeat in subse-
quent sprays as needed. In OR,
wettable powder may be applied by
aircraft in 5 to 7 gallons of
spray per acre on the above sche-
dule. Apply dusts using ground
equipment or aircraft on above
schedule.
May be formulated with parathion
and sulfur.
SLN - Use limited to Cft.
Delayed dormant and foliar appli-
cations, ftpply by aircraft in
not less than 1O gallons per
acre. Apply 8 times per year.
0. 3 ppm
Do not apply after shucks have
started to open through 4.55
pounds per acre.
Do not graze meat or dairy ani-
mals in treated groves.
Severe folige injury has been
experienced on Moore and Van
Deman varieties in the southeast.
Delayed dormant and foliar appli'
cations. ftpply when first leaves
are showing and repeat at 10 to
14 day intervals through first
cover. Repeat at £ to 3 week in~
tervals or as needed. By air-
craft, apply 1.3 pounds per acre
(or £. 6 pounds per acre under
severe scab conditions) in a
mum of £O gallons of spray.
Issued: 3-11-86
II-O44301-7
-------
EPA Compendium of Acceptable Uses
DODINE
Site and Pest
/01016AA Strawberry
-BflTDAH Leaf blight
(Dendrophorna)
FGflKDBS Leaf scorch
(Diplocarpon)
FMBCMCO Leaf spot
(Mycosphaerel-
la)
Dosages and
Formal at ion <
Tolerance. Use. Limitations
)
5 ppm
14 day preharvest interval
through 1.3 pounds per acre.
O.9-1.3 Ib/A Delayed dormant and foliar appli-
cations. Apply as soon as new
growth starts and repeat at week-
ly intervals. Apply wettable pow-
der in sufficient water for thor-
ough coverage (£5O to 3OO gal-
lons) -
WP)
(IX, 4X D)
or
O.0£-0.O£5
1b/1,OOO
sq. ft
(IX D)
/35056AA
FEAJVAG
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees
Flowering Crabapple
Apple scab
(Venturia)
/341£OAA
Rose
FMAEDB5
Black spot
(Diplocarpon)
/35119AA
Sycamore
Anthracnose
(Gnornonia)
0.6-0.8 Ib/A Delayed dormant and foliar appli-
or
0.O£-0. 0£5
Ib/mature
tree
(IX D)
cations. Apply during prebloom.
Repeat at 5 to 7 day intervals
through first cover.
Higher dosages may cause stunting
and foliation on first year
plants and chlorosis on older
established plants.
0.3-0.4 Ib/A Foliar application. Apply when
(IX, 4X D) young leaves first appear. Re-
or peat at 7 to 10 day intervals
O.O075—0.01 throughout the season. Dust
lb/l,OOO lightly but thoroughly.
sq. ft
(IX D)
0.65-O.975
Ib/lOO gal
(65X WP)
Delayed dormant and foliar appli-
cations. Apply at high rate when
buds start to swell. Repeat at
low rate when buds break open and
again 1O to 14 days later.
Issued: 3-11-86
11-044301-8
-------
EPft Compendium of ftcceptable Uses
DODINE
Site and Pest Dosages and Tolerance. Use, Limitations
Formu 1 at i on ( s )
flQUQTIC NONFOOD
(ftquatic Sites)
Brewery Pasteurizer Water See Commercial and Industrial
Recirculat ing Mater Cooling
Systems.
/65019Mfl Commercial and Industrial
Recirculat ing Water Cooling Systems which are heavily contarni-
Sy sterns nated must be cleaned before
treatment. Dosage will depend on
the condition of the system prior
to t r eat ment .
ftlgae 0.01-0.3 lb/ Water treatment (1.2 to 36 ppm
1,OOO gal active ingredient). Apply to the
DBftBftftft Slime-forming system water cleaned system or when growth is
bacteria <5#, 1OS RTU) first noticed. Initial dose: ftp-
ply O. 2 to O. 3 pound (24 to 36
PYftFQBB Slime-forming ppm) continuously; or apply once,
fungi twice, or three times weekly or
as needed. Subsequent dose:
When control is evident, apply
0. Ol to O. 2 pound (1.-2 to 24 ppm)
as a continuous treatment daily
or every 3 days as needed.
Issued: 3-11-86 II-O443O1-9
-------
Site and Pest
EPA Compendium of Acceptable Uses
DODINE
Dosages and Tolerance, Use. Limitations
Formulat ion(s)
/65019MA
/650O5M.Q
PKftfififtfi
FYflFQBB
/65025MA
PKAAflfifl
FVfiFQBl
(evaporative condensers,
heat exchanger water sys-
tems, commercial and in-
dustrial cooling towers,
influent systems such as
flow through filters,
ponds, lagoons, industrial
water scrubbing systems,
and brewery pasteurizers)
fllgae 0.01-0.4 lb/
1,OOO gal
system water
(10* RTU)
SIime-forming
bacteria
SI ime-forming
fungi
Oil Field Water Systems (oil
field water, polymer, or rny-
cellar floods, water disposal
systems or other oil field
water systems)
Algae
SI irne-f orming
bacteria
Sulfate reduc-
ing bacteria
SIime-forming
fungi
1.0-10.O lb/
1,OOO bbl
water
(10* RTU)
Water treatments (1.2 to 48 ppm
active ingredient). Slug or in-
termittent method. Initial dose:
When system is noticeably fouled,
apply 0.05 to O.4 pound (6 to 48
ppm). Repeat until control is
achieved. Subsequent dose: When
control is evident, apply O.01 to
O. £ pound (1.2 to 24 pprn) every 3
days or as needed. Cont inuous
method. Initial dose: When the
system is noticeably fouled, ap-
ply O.OS to O.4 pound (6 to 48
ppm). Continue until control is
achieved. Subsequent dose: When
control is evident, continuously
feed to maintain a dosage of O. 01
to O.2 pound (1.2 to 24 ppm) per
1,OOO gallons of blowdown (or
water loss) from the system.
Do not apply in marine and/or
estuarine oil fields.
Badly fouled systems should be
cleaned prior to treatment. Dos-
age will depend on the condition
of the system prior to treatment.
Water treatment (3.O to 3O ppm
active ingredient). Slug or in-
termittent method. Initial dose:
When the system is noticeably
fouled, apply 1.0 to 1O. O pounds
(3.0 to 30 ppm) intermittently
for>4 to 8 hours per day and from
1 to 4 times per week or as need-
ed. Repeat until control is
achieved. Subsequent dose: When
control is evident, apply 1.0 to
7.5 pounds (3.O to 22.5 ppm)
every 3 days or as needed.
Issuea: 3-11-86
11-044301-10
-------
EPA Compendium of Acceptable Uses
DODINE
Site and Pest
Dosages arid Tolerance.
Formulat ion .
Water treatment. Slug or inter-
mittent method. Initial dose:
When system is noticeably fouled,
apply 0.0048 to O.O48 pound per
ton (£.4 to £4 pprn) ; apply 0. O£4
to 0.19 pound per 1,OOO gallons
(£.9 to £3 ppm) directly to the
additive system. Repeat until
control is achieved. Subsequent
dose: When control is evident,
apply 0.OO48 to O.O£4 pound per
ton (£.4 to 1£ ppm) as needed to
maintain control. Treat the addi"
tive system at O.01£ to 0.096
pound (1.4 to 11.5 pprn).
Issued: 3-11-86
II-O44301-11
-------
Site and Pest
EPft Compendium of Acceptable Uses
DODINE
Dosages and Tolerance. Use, Limitations
Formu1at i on(s)
Pulp and Paper Mill Systems (continued)
Continuous method. Initial
dose: Apply as in slug or inter-
mittent method. Subsequent dose:
When control is evident, contin-
uously feed to maintain a dosage
of 0.OO4B to 0.014 pound per ton;
and apply 0.048 to O.O7£ pound
per 1,OOO gallons (0.58 to 8.6
pprn) to the additive system.
Formulated with methylene*bis—
(t h i ocyanat e).
/810070ft
INDOOR
(Industrial Preservatives and ftdditives)
Metalworking Cutting Fluids
soluble cutting oil, semi-
synthetic and synthetic type
metalworking fluids, hydrau-
lic fluids, and chemical
coolants)
DBADfiflfl
DBfiBfiftft
DBftEflftft
FYfllQBB
Deteriorat ion/
spoilage bac-
t er i a
SIime-forming
fungi
Su1 fat e-red uc-
ing bacteria
Fungi
CMftlU
0.0045-
O. O135% a. i.
by volume of
diluted
cutt ing
fluid
or
O.041-0.1£
Ib/lOO gal
of diluted
cutting
fluid
RTU)
Preservative incorporation.
Formulated with hexahydro—1,3,5-
tris(£—hydroxyethyl)-s-triazine.
Is®ued: 3-11-86
11-044301-12
-------
Site and Pest
EPA Compendium of Acceptable Uses
DODINE
Dosages and Tolerance. Use. Limitations
Formu1at i on < s)
Oil Recovery Drilling Fluids
(packer fluids and drilling
muds)
DBABAftft
DBAEAAA
SI irne-f orrning
bacteria
Su1 fat e-red uc-
ing bacteria
5.O-5O.O lb/
1,OOO bbl
or
8.O-8O ppm
a. i.
(10% RTU)
/eioiooA
FYADQBB
FYAHQBB
Paper and Paper Products
Bact er i ost at
Fungi
Yeasts
up to O.4%
a. i. by
weight of
paper or
paperboard
(95* WP/D)
or
up to 0.Q%
a. i. by
weight of
paper or
paperboard
(95* WP/D)
Do not apply in marine and/or
estuarine oil fields.
Additive incorporation. Add
directly to the packer fluid or
drilling mud. The dosage rate
will depend upon the severity of
the contamination.
Preservative incorporation. Form-
ulation may be added to the pulp
stock in the beater or applied to
the formed sheet by size press or
rollcoater, or as a uniform
spray. Food packaging. Apply in
accordance with £1 CFR, Section
176.170: For use only in paper
and paperboard to be in contact
with aqueous and fatty nonalcoho-
lic foods having a pH above 5 at
a level not to exceed O.4 percent
active ingredient by weight of
the paper or paperboard; or, for
use in the outer ply of multiwall
paper bags for contact with dry
foods (dry solids with the sur-
face containing no free fat or
oil) at a level not to exceed O. 8
percent active ingredient by
weight of the paper. Industrial
or agricultural paper and paper-
board products. Add up to O. 8
percent active ingredient by
weight of paper or paperboard
when paper or paperboard product
is to be subjected to excessive
leaching as by rainfall or con-
tact with ground water.
Issued: 3-11-86
II-O44301-13
-------
Site and Pest
EPfl Compendium of ftcceptable Uses
DODINE
Dosages and Tolerance. Use. Limitations
Formulat ion(s)
/B1Q1GOR
/SlGOlOfl
/810OEOR
fl£4
FYftDQBB
Preservation of Pulp and Paper
Mill Processing Chemicals.
fidhesives. and Coat ings
Bacteriostat
Fung i
CMAI3
9. 4-48 pprn
a. i.
(4.754, 4. 8'/.
RTU)
Preservative incorporation. ftdd
directly to the material to be
preserved prior to manufacturing
into the finished product, i.e.,
pulp, broke, polymers, defoarners,
alum, emulsions, adhesives, paper
mill coatings, pigment slurries,
and paper products. The dosage
rate will depend upon the mate)—
ial to be preserved and the stoi—
age time. The usual addition
should be 3.4 to 14 pprn. Under
extreme conditions of spoilage,
the dosage rate should be increas-
ed to 12 to 38 pprn. The above
recommendations are based on a
maximum storage time of £ weeks.
For storage greater than £ weeks,
the maximum concentration should
be increased to 48 ppm.
Formulated with alkyl*dimethyl
benzyl ammonium chloride *alkyl
(50-/. C14, 40* Cl£, 10% C16) ; or,
methylene bis(thiocyanate).
9001500
flERIQl. flND TftNK MIX flPPLICPTIDNS
fierial application
9900300
Tank Kix
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
flpple, Cherry, Pear, Pecan,
Strawberry
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
Flowering Crabapple, Rose
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Peach
Issued: 3-11-86
II-0443O1-14
-------
EPft Compendium of Acceptable Uses
DODINE
Listing of Registered Pesticide Products by Formulation
&-09B.9O01 98. 9% technical chemical
dodine (O443O1)
000£41-00£69
&075. OOO£ 75# formulation intermediate
dodine (O443O1)
OOO241-OOO63
&095. OOOS 95'X formulation intermediate
dodine (O443O1)
049854-00015
& 001.0003 1% dust
dodine (O443O1)
O0859O-OO165
&00£. 0003 £% dust
dodine (O443O1)
OOO595-OO219 OO£393-OO£OO* OO8590-OO459
*currently unavailable for review
dodine (O443O1), parathion (O575O1) plus sulfur or sulphur
(0775O1)
OO5481-00£97
&003. 0003 3'yt dust
dodine (O443O1)
OOO241-OOO61 OOO595-OOS65
&003. 90O3 3. 9* dust
dodine (O443O1), sulfur or sulphur (077501) plus captan
-------
EPft Compendium of ftcceptable Uses
DODINE
Listing of Registered Pesticide Products by Formulation (continued)
&0££. 5O06 ££.5% wet table powder
dodine (044301) plus glyodin (O436O1)
008590-00277
&OB5. 0006 65'/. wet table powder
dodine (0443O1)
OOOS41-OO051 OO£749-OO15£
C«780O4£
&095. 0007 95'/. wet table powder/dust
dodine (O443O1)
049854-OOOO9
&£04.7O16 4.7% (0.38 Ib/oal) liquid-ready to use
dodine (O44301) plus alkyl*dimethy1 benzyl ammonium chloride
*alkyl (50* C14, 4O* Cl£, 10% C16) (0691O5)
O45017-00023
&£04.8016 4.8% (0.39 Ib/cial)liquid-ready to use
dodine (O443O1) plus methylene bis(thiocyanate) (O681O£)
O45O17-OOO£4
&£05.O016 5% (O.4£ Ib/gal) liquid-ready to use
dodine (O44301)
009386-OOO17
&£09.OO16 9* liquid-ready to use
dodine (O443O1) plus hexahydro—1, 3, 5—tris(£—hydroxyethyl)—s-tria-
zine (083301)
001839-00117
&£1O.OO16 10* liquid-ready to use
dodine (O443O1)
003876-00049
&£1O.OO16 1O% (O.79 Ib/oal) liquid-ready to use
dodine (O443O1)
O03876-OOO77 O34571-OOOO4 O48525-OOOO5
&£10.O016 1O% (O.84 Ib/oal) liquid-ready to use
dodine (O443O1)
O09386-OOO16
9999999 State Label Registrations
MI Reg. No.
000635-08179
NY Reg. No.
O38655-1O45£
Issued: 3-11-86 II-O443O1-16
-------
EPfi Compendium of Acceptable Uses
DODINE
ftppendix ft-i
Listing of ftctive Ingredient(s) Found in Combination with the
Report Chemical
Chemical Common Name
Code (source)
O&91O5 alkyl*dimethyl benzyl ammonium
chloride *alkyl <50'/. C14, 40*
CIS, lO'/C C16>
EPft Acceptable
Common/Chemical Name
081301
03480 1
043601
08330 1
068102
057501
077501
captan
ferbarn
g 1 yod i n
hexahydro-1, 3, 5-tris <£-hydroxy-
ethyl ) -£-triazine
methylene
parathion
sulfur
b i s ( t h i ocyanat e )
sulfur or sulphur
— Use Common Name
Issued: 3-11-86
II-0443O1-17
-------
EPA Compendium of Acceptable Uses
DODINE
Appendix A-£
Listing of Active Ingredient Which May Be Included in Tank Mixes
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical Name
081301 captan —
— Use Common Name
Issued: 3-11-86 II-O4A3O1-18
-------
Pfl Compendium of Acceptable Uses
DODECYi-GUftNIDINE HYDROCHLORIDE
Site and Pest
Dosages and Tolerance. Use. Limitations
Forma1at i on(s)
/65035KR
FYftFGBB
/65019Mfi
PKftfiftftft
FYftFQBB
Commercial anc Industrial
fluxiliary Water Systems -
General
-------
Sire- ar.c Pest
EPft Compendium of ftcceptable Uses
DODECYLGUftNIDINE HYDROCHLORIDE
Dosages and Tolerance. Use. Limitations
Forrnu 1 at i on (s)
Commerci al and Industrial Water Cooling Systems (continued)
0.0£7-O. 17 Water treatment (3.3 to £0 pom
lb/l,OOO gal active ingredient). SI up method.
system water Initial dose: When system is no-
(1£. £5*, £0* ticeably fouled, apply 0.055 to
RTU) O.17 pound (6.6 to £0 ppm).
Repeat until control is achieved.
Subsequent dose: When control is
evident, apply O.0£7 to 0.115
pound (3. 3 to 14 pprn) 1 to 3
times per week or as needed to
rna i rut a i n cont ro 1.
13-1 £8 fl.oz Water treatment (5. £5 to 5£. 5 pprn
5. £55t RTU/ active ingredient by volume).
1,OOO gal Sluo method. Initial dose: ftp-
system water ply 3£ to 1£8 fluid ounces (13 to
(5.£5% RTU) 5£. 5 ppm). Subsequent dose: ftp-
ply 13 to 5£ fluid ounces (5.£5
to £1 ppm) 1 to £ times per week
or as needed. For severe con-
tamination, apply at initial
rate.
CMOI3
O.0044-0.175
Water treatment (0.53 to £1 pprn
active ingredient). Intermittent
lb/l,OOO gal or slug method. Initial dose:
water
(10. 78-/. RTU)
When the system is noticeably
fouled, apply O.O675 to 0.175
pound (8.0 to £1 pprn). Repeat
until control is achieved. Sub-
sequent dose: When control is
evident, apply 0.O££ to O.O675
pound (£.7 to 1O.5 ppm) weekly or
as needed to maintain control.
Continuous method. Initial dose:
When the system is just notice-
ably fouled, apply O.044 to
O.O875 pound per 1,OOO gallons of
makeup water (5. £5 to 10.5 pprn).
Subsequent dose: Maintain ini-
tial dose level by continuously
feeding 0.OO44 to O.O44 pound per
1,OOO gallons of water lost by
blowdown (0.53 to 5. £5 ppm).
Formulated with bis(tributyltin)
oxide.
Issued: 3-11-86
II-O44303-5
-------
EPft Compendium of Acceptable U
•DODECYLGUflNIDINE HYDRDCHLORIDE
Sit £• and Pest
Dosages and
Forrnu 1 at i on (i
Tolerance. Use, Limitations
O. O025-0. 1
lb/1,000 gai
system water
(5%, 10% RTU)
Corn mereia] and Industrial Water Cooling Systems (cont i n ued)
Water treatment (0.3 to If ppm
active ingredient). For use in
evaporative condensers, heat
exchange water systems, commer-
cial and industrial cooling
towers, influent systems such as
flow through filter, lagoons, and
industrial water scrubbing
systems. Intermittent or si UP
method. Initial dose: when tne
system is noticeably foulea, ap-
ply O. 015 to O.I pound (1.8 to i£
pprn). Repeat until control is
achieved. Subsequent dose: Ulnen
control is evident, apply 0.0075
to O. 075 pound
-------
and Pes-i
Compendium of Acceptable Uses
DGDECYLGUftNIDINE HYDROCHLORIDE
Dosages and Tolerance. Use. Limitations
Formu1at i on(sL
Commercial and Industrial Water Cooling Systems (continuea)
(once-through and closed-
cycle fresh and sea water
cooling systems, cooling
ponds, canals, and lagoons)
PKftfifififi
IGftftftftfi
DBftBftftft
FYfiFG'BB
fii gae
Mol1usks
CReg. No.
003676-00145D
51i me—form ing
bacteria
S i i me-form ing
fungi
CMfilD Water treatment (0. 1£ to 6.0 pprn
O.OO1—0.O5 active ingredient). 51 up or in-
lb/l,OOO gal termittent method. Initial dose:
system water When the system is noticeaoly
<5'/. RTU) fouled, apply 0.01 to 0.05 pound
-------
EPfi Compendium of Acceptable Uses
Site ana Pest
DDDECYLGUANIDINE HYDROCHLORIDE
Dosages ana Tolerance,
Forrnu 1 at i on (s)
Use. Limitations
/65O£5*.P Gil Field Water Systems (oil
field water, polymer or mycel-
lar floods, water disposal
systems or other oil field
water systems)
Do not apply in marine ana/or
estuarine oil fields.
Badly fouled systems should be
cleaned prior to treatment.
Addition may be made at the free
water knockouts before or after
the injection pumps and injection
well headers.
PKAAAAA
ElBftBAAA
FYftFQBB
FVflHQBB
Algae
SIime—forming
bacteria
Sulfate-produc-
ing bacteria
Si ime—forming
fungi
Yeasts CReg.
No. 3876-145,
5% RTU3
CMftID
O. 4-7. 5 lb/
1,000 bbl
water
(1054 RTU)
Water treatment (1.1 to £1 pprn
active ingredient). Slug or
intermittent method. Initial
dose: Apply 1.0 to 7.5 pounce
(£.8 to £1 pprn) intermittently
for £ to 8 hours per day once per
week or daily as needed. Repeat
until control is achieved.
Subsequent dose: Wnen control i&
established, apply O.4 to 7.O
pounds (1.1 to £0 pprn) every 3
days or as needed to maintain
cont ro 1. Corit i nuous met hod.
Initial dose: When the system is
noticeably fouled, apply 1.0 to
7.5 pounas (£.8 to £1 pprn).
Continue until control is
achieved. Subsequent dose: Con-
tinuously feed to maintain a dos-
age of 0.4 to 7.0 pounds (i.i to
£0 pprn.
Formulated with metnylene bis-
(thiocyanate).
CMA13 Water treatment (O. 15 to £5 pprn
0.05-8.£5 lb/ active ingredient). Slup or
1,OOO bbl
water
RTU)
intermittent method. When tne
system is noticeably fouled, or
to maintain control of the sys-
tem, apply 0.5 to 8. £5 pounds
(1.5 to £5 pprn) intermittent ly
for 4 to 8 hours per day, and
from 1 to 4 times per week or as
needed depending on the severity
of contamination. Continuous
method. When the system is no-
ticeably fouled, apply O.5 to
8. £5 pounds (1.5 to £5 pprn)
continuously until the desirea
degree of control is achieved.
Issued: 3-11-86
II-044303-8
-------
EPft CornDendiurn of ftcceotaDie Uses
Site ans Pest
DDDECYLBURNIDINE HYDROChL-OR IDE
Dosages and Tolerance. Use, Limitations
Forrnu I at i on < s)
Oil Field Water Systems (oil field water, polymer or rnycel-
lar floods, water disposal systems or other oil field
systems) (continued)
Subsequently, apply 0.05 to 1.5
pounds (0.15 to 4.5 ppm)
continuously or as needed to
maintain control.
Formulated with al ky l*dirnethy 1
benzyl ammonium chloride *alkyl
(5O* C14, 40* C12, 107. C16).
/650O8Mft
Pulp anci Paper hill Systems
FYABQBB
B i i rne- form ing
bacteria
51 i rne-f orrn i ng
f unc i
CMfilD
0.OO75-O.1
Ib/ST pulp
or paper
produced
C3.7-50 ppm
a. i. D
(5%, 10* RTU)
CMftID
0.005-0.4 lb/
1,OOO gal
addit ive
syst ern
CO. 6-48 ppm
a. i. j
(5-/., 10% RTU>
flpply directly to the pulp ano
paper mill system at a point
where the formulation will be
uniformly mixed.
Water treatment. Intermittent or
slug method. Initial dose: Wnen
the system is noticeably fouled,
apply 0.OO75 to O.I pound per
short ton. ftpply O.O05 to 0.4
pound directly to the additive
system. Repeat until control is
achieved. Subsequent dose: wnen
control is evident, apply 0.0075
to O.1 pound per ton. Treat as
needed to maintain control. ftp-
ply 0.OO5 to O.£ pound to tne
additive system. Cont inuous
method. Initial dose: When the
system is noticeably fouleo. ap-
ply 0.O075 to O.I pound per ton.
ftpply O. OO75 to 0.4 pound direct-
ly to the additive system. Re-
peat until control is achieved.
Subsequent dose: Continuously
feed to maintain a dosage of 0.1
to 0.O3 pound per ton. ftpoly
0.01 to 0.15 pound to the addi-
tive system.
Formulated with rnethylene bis-
(thiocyanate) ; or alkyl»dirnethyi
benzyl ammonium chloride *alkyi
(50* C14, 40* Cl£, 10* C16).
Issuec: 3-11-86
II-O44303-9
-------
EPS Corn oendi urn of Acceptable Uses
DODECYLGUftNiIDINE HYDROCHLORIDE
Site arid Pest
Dosages and Tolerance,
Form u1at i on(s)
Use, uirni tat i ons
/650SG.YP.
Disposal Lanoons
filcae
O.33-0.5 oz/
100 so.ft
of surface
RTLJ)
Water surface treatment. Dosage
depends upon the population den-
sity of tne algal blooms. Trie
interval between treatments de-
pends upon tne reappearance of
algal blooms and subsequent treat-
ments should be made as spot
treatments at the same dosage as
the initial treatment. Dilute
with water to accommodate the
delivery characteristics of tne
pump and spray rig, and apply
evenly to the surface of tne
lagoon.
INDOOR
(Industrial Preservatives and field it ives)
/Si. 0170ft Disposal Diapers (paper)
Bacteriostat
0. OB'/- a. i. in Impregnated paper diaper.
paper diaper
(0. OGtf Irnpr)
/6100BO&
DBftBftfifi
DBftEftflfi
(£4.74% RTU)
Oil Recovery Drilling Fluids
(packer fluids and drilling
muds)
fldditive incorporation. Dosage
rate not specified on labelling.
Do not apply in marine or est uai—
me oil fields.
S1i me-form ing
bacteria
Suifate-reauc-
ina bacteria
CMftID fldditive incorporation. flad
5.0—5O.0 lb/ directly to the packer fluid or
1,OOO bpl drilling mud. The dosage rate
or will depend upon the severity of
8. O-80 pprn the contamination.
a. i. Formulated with methylene bis-
(1O-/C RTU) (thiocyanate) .
Issued: 3-11-86
II-044303-10
-------
Site and Pest
EPft Compendium of Acceptable Uses
DODECYLGUfiNIDINE HYDROCHLORIDE
Dosages and Tolerance. Use. Limitations
Formulat ion (s)
/SlGiOOH Paper and Paper Products
ftc-4
Bacteriostat O. O175-O. £"/. Preservative incorporation.
a. i. by
weight of
paper or
pa per board
(£4.74% RTU)
O. O45tf a. i. Impregnated glassine paper-
in steriliz-
ed glassine
paper
«X 045'/. Irnpr)
FYfiDQBB
FVfiHQBB
Bacteriostat
Fungi
Yeasts
a. i. in Impregnated napkins.
napkins
(O. 0£# Impr)
up to O.4%
a. i. by
weight of
paper or
paperboard
or
up to 0.6%
a. i. by
weight of
paper or
paperboard
(33* RTU)
Preservative incorporation.
Formulation may be added to tne
pulp stock in the beater or ap-
plied to the formed sheet by size
press or rollcoater, or as a
uniform spray. Food packaging.
ftpply in accordance with £i CFR,
Section 176.17O: For use only in
paper and paperboard to be in
contact with aqueous and fatty
nonalcoholic foods having a pH
above 5 at a level not to exceed
O.4 percent active ingredient py
weight of the paper or paper—
board; or, for use in the outer
ply of multiwall paper bags for
contact with dry foods (dry
solids with the surface contain-
ing no free fat or oil) at a
level not to exceed O.8 percent
active ingredient by weight of
the paper. Industrial or agricul-
tural paper and paperboard pro-
ducts, fidd up to O. 8 percent
active ingredient by weight of
paper or paperboard when paper or
paperboard product is to be sub-
jected to excessive leaching as
by rainfall or contact with
ground water.
Issued: 3-11-66
H-044303-11
-------
Site and Pe;
EPfl Cornpendi urn of Acceptable Uses
DODECYLGLJftNIDINE HYDROCHLORIDE
Dosages and Tolerance. Use. Limitations
Forrnu 1 at i on (s)
Maper arid Paper Products (continued)
"YPiBQBS
Moid inhibition
/610160ft
/eiooiofi
/BiOOEOft
fi£4
FYADQBB
CMftID
O.5-£.0 Ib/ST
of dry fiber
produced
or
£0-1OO pprn
a. i. in the
sizing solu—
t ion
(10JC RTU)
Preservation of Pulp and Paper
Mill Processing Chemicals.
fldhesives. and Coatings
Bacteriostat
Fungi
CMAI3
1O-100 ppm
a. i.
(5%, 10% RTU)
Preservative incorporation. For
use in paper and paperboard
grades for construction, indus-
trial, and nonfood uses. Apply
O.5 to £.O pounds to the hydro-
pulper or dump chest, or £O to
100 pprn at the size press or
Mater box.
Formulated with methylene bis-
(thiocyanate).
Preservative incorporation. ftdc?
directly to the material to be
preserved prior to manufacturing
into the finished product, i.e.,
pulp, broke, polymers, defoamers,
alum, emulsions, adhesives, paper
mill coatings, pigment slurries,
and paper products. The dosage
rate will depend upon the mater-
ial to be preserved and the stoi—
age time. The usual addition
should be 10 to 30 ppm. Under
extreme conditions of spoilage,
the dosage rate should be increas-
ed to 1£. 5 to 60 pprn. The above
recommendations are based or. s-
maximum storage time of £. weeKS.
For storage time greater than £
weeks, the maximum concent rat i or:
should be increased to 50 to 100
ppm.
Formulated with methylene bi.5-
(thiocyanate); or alkyl*dim&thy1
benzyl ammonium chloride *alkyl
(50% CIA, 40X Cl£, 10% CiG).
Issued: 3-11-86
II-O443O3-1£
-------
EPfi Compendium of ftcceptable Uses
DODECYi-GUfiNIDINE HYDROCHLORIDE
Listing of Registered Pesticide Products by Formulation
&-IE.33. O00£ 33* (£.64 ib/gal) formulation intermediate
dodecy1guanicine hydrochlorioe (O44303)
O49854-OOO1£ -049854-00017
& 000. 0£' 10 0. Oi="/. impregnated materials
dodecyIguanidine hydrochloride (044303)
O07973-OOOO1
&000. 0410 0.045'/. irnprepnated materials
dodecy1guanidine hydrochloride (O44303)
OO8683-OOOO1
&OOO.O610 0. O6* impregnated materials
dodecyIguanidine hydrochloride (O44303)
OO£914-OOO£6
&£05.OO16 5S liquid-ready to use
dodecy1guanidine hydrochloride (O44303) plus alkyl*dirnetny1
benzyl ammonium chloride *aikyl (5O'/. C14, 40* Cl£, 10'/. C16)
(O691O5)
003876-00145 O45O17-O0035
&£05.£516 5.£5% 1iauid-ready to use
oodecylguanidine hydrochloride (O44303)
O1O445-O0008
&£• 10. OOi6 JO'/, liquid-ready to use
dodecy Iguanid me nydrochloride (O44303) plus nietnyiene Pis(tr.io-
cyanate) (0661O£)
003876-00121 034571-00013 045O17-O0028 0485£5-OOOOc:
oodecylguanidine hydrochioride (O44303), bis(trichiorornethyi)
sulfone (035601) plus alkyl*dirnethyl benzyl ammonium chloride
*alkyl <50'/. C14, 40'/. Cl£, 1O'/. C16) (069105)
OO3876-OOO5£
&-£lO. 7616 10.78% liquid-ready to use
dodecylguanidine hydrocnioride (O44303) plus bis (tributyltin)
oxide (083001)
01O445-OOOO6
&•£ 1 £. £516 1£. £5?t liquid-ready to use
dodecylguanidine hydrocnioride (044303)
O1O445-OO003
&££O. OO16 £O^ (1.6£ Ib/pal) liquid-ready to use
dodecylguanidine hydrochloride (O443O3)
O0964O-OOO34
Issued: 3-11-86 II-O44303-13
-------
EPA Compendium of Acceptable Uses
DDDECYi_GUANIBINE HYDROCHLORIDE
Listing of Registered Pesticice Products by Formulation (cont ir> -
&££4.7416 £4. 7A'/, liquid-ready to use
dodecy Iguanid ine hydrochiori.de (O44303)
O10445-00042
&£33. 0016 33'/. (£.64 Ip/qal) liquid-ready to use
ooaecylguaniaine hydrochloride (O44303)
049654-00010 049654-00011 O49654-O0016 049654-00016
Issued: 3-11-86 II-O443O3-14
-------
EPft Compendium of flcceptabie Uses
DQDECYLGUftN I D I NE HYDROCt-iLGR I Dt
ftppendix ft— i
Listing of Active Ingredient (s) Found in Combination wirn tne
Report Chemical
Chemical Common Name EPR
Code (source) Common /'Cher!-; i ca 1 \ar--e-
O&9105 al kyl*dirnetnyl benzyl ammonium —
chloride *aikyi (50>4 CIA, 40'/.
Cl£, 1094 C16)
OB3001 bis
-------
EPft Compendium of flcceptable Uses
DODECYLGUflNIDINE TEREPHTHftLftTE
TftBLE OF CONTENTS
Site Name Page
INDOOR 1
(Commercial and Industrial Uses) 1
Textiles (industrial, nonclothing textiles) 1
I«*ued s 3-11-86 11-044302-i
Provisional Update: 05-07-87
-------
EPA Compendium of Acceptable Uses
cOAA30£ DODECYLGUANIDINE TEREPHTHALATE
TYPE PESTICIDE; Fungicide, Antimicrobial
FORMULATIONS; EC
-------
EPA Compendium of Acceptable Uses
DODECYLGUANIDINE TEREPHTHALATE
Listing of Registered Pesticide Products by Formulation
&£10.0014 10% (0.6 Ib/oal) emulsifiable concentrate
dodecylguanidine terephthalate (O443O£>
002829-00088
Issued: 3-11-86 II-O443O2-2
-------
EPft Cornpendi urn of Acceptable Uses
DODECYLGUflNIDINE HYDROCHLORIDE
TflBLE OF CONTENTS
Site Name Page
flDUOTIC NONFOOD
(ftquatic Sites) £
INDOOR
(Industrial Preservatives arid ftdditives) 1O
fiir Washer Water Systems £
Brewery Pasteurizer Water 3
Commercial and Industrial ftuxiliary Water Systems - General 4
Commercial and Industrial Water Cooling Systems 4
Disposal Diapers 1O
Ci1 Field Water Systems 8
Oil Recovery Drillng Fluids 10
Paper and Paper Products 11
Preservation of Pulp and Paper Mill Processing Chemicals.
fldhesives, and Coatings 1£
Pulp and Paper Mill Systems 9
Sewage Disposal Lagoons 1C
Issued: 3-11-86 II-O44303-1
Provisional Update: 5-07-87
-------
EPA Compenoium of Acceptable Uses
C044303 DODECYLGUANIDINE HYDROCHLORIDE
TYPE PESTICIDE; Fungicide, Ant imicrobial, Algaecide, Moiluscicioe
FORP1L
ILAT
FI (£.
Irnpr (0.
RT U < 5%
33%
GENERAL.
IONS
•
•
64 Ib/gal or
0£X, O. O4556,
, 5. £5'/., 1O-/.,
)
WARNINGS AND
33 y->
O. O6K )
10.7854, IE-
LIMITATIONS
£5'/.,
£4.
£.64 Ib/gal or
face shield and
Registration
Wear goggles or
chemical resistant gloves when handling. Refer to
Guidance Package regarding decontamination.
Observe all warnings and limitations for other active ingredients
on multiple active ingredient labels.
Dosage rates are given in active ingredient. The dosage rate will
depend upon the severity of contamination, the type of system, and
the method of application.
Definition of Terms;
l - multiple active ingredient (s)
Issued: 3-11-86
Provisional Update:
II-O443O3-1
5-07-87
-------
EPfl Compendium of Acceptable Uses
DODECYLGUBNIDINE HYDROCHLORIDE
Dosages arid
Formu 1 at i on (!
Site and Pest
ftC'UftTIC NONFOOD
(Qguatic Sites)
ftir Washer Water Systems
Tolerance, Use, Limitations
FYAFQBB
SIime—forming
bacteria
S1i me-formi ng
f ung i
For use only in industrial air
washer systems that maintain
effective mist eliminating com-
ponents. Badly fouled systems
must be clean before treatment is
begun.
Water treatment (l.£ to 1£ pprn
O.O1-0.1 lb/ active ingredient). Slug or in—
1,000 gal termittent method. Initial dose:
system water When the system is noticeably
(10* RTU) fouled, apply 0. 0£ to O.I pound
(£.4 to 1£ ppm). Repeat until
control is achieved. Subsequent
dose: When control is evident,
apply 0.01 to O.O75 pound
-------
Site and Pest-
EPft Compendium of Acceptable Uses
DODECYLGUftNIDINE HYDROCHLORIDE
Dosages and Tolerance. Use. Limitations
Formalat ion(s)
/GSOQSMfl
Brewery Pasteurizer Water
DBftBftfifi
FYQBQBB
S1 i me—form ing
bacteria
SIime-forming
f uno i
Badly fouled systems must be
cleaned before treatment is
begun.
CMftID Water treatment (0.9 to IS pprn
O.GOS5-O.1 active ingredient). Slug or
lb/l,OOO gal intermittent method. Initial
system water dose: When the system is notice-
10'/. RTU) ably fouled, apply O. O15 to 0.1
pound (1.8 to IS pprn). Repeat urv
til control is achieved.
Subsequent dose: When control is
evident, apply 0.0075 to 0.075
pound (0.9 to 9.0 pprn) every 3
days or as needed to maintain
control. Continuous method.
Initial dose: When the system is
noticeably fouled, apply 0.015 to
O.11 pound (1.6 to IS ppm).
Subsequent dose: Continuously
feed to maintain a dosage of
O.O075 to O.O75 pound (O.9 to 9.0
ppm) for the 10 percent formula-
tion, or O.OOS5 to O.OSS pound
(0.3 to 3.0 ppm) for the 5 per-
cent formulation.
Formulated with methylene bis-
(thiocyanate) ; or alkyl*dirnethyi
benzyl ammonium chloride #alkyi
(50* Ci4, 40-/. Cl£, 10-/. C16).
Issued: 3-11-66
II-O44303-3
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first 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. 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 text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use 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.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "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.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Dodine Standard
MRID CITATION
00034562 American Cyanamid Company (1958) Cyprex, Dodecylguanidine acetate
Residues fron Pears. (Unpublished study received Mar 17, 1968
under 241-51; CDL:001692-E)
00035127 American Cyanamid Company (1958) Dodecylguanidine acetate Residues
from Apples. (Unpublished study received Nov 25, 1959 under
241-51; CDL:001688-D)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees,:
Laboratory Studies. By University of California, Dept. of
Entomology. ?: UC, Cooperative Extension. (Leaflet 2287;
published study.)
00058170 Curry, A.N. 1962. Translocation and metabolism of dodecylguanidine
acetate (Dodine) fungicide in apple trees, using C-14 radiotagged
Dodine. Journal of Agricultural and Food Chemistry 10(1):13-17.
(Also in unpublished submission received Nov. 28, 1977 under
1730-43; submitted by American Cyanamid Co.; Consumer Products
Research Div.; CDL:232344-E).
00070339 West, B.; Vidone, L.B.; O'Grady, J.J.; et al. (1958) Dodecylguanidine
Acetate (DDGA): I. Acute and Subacute Toxicity—CL 7521: Report
No. 58-21. (Unpublished study received Jun 27, 1969 under
unknown admin, no.; prepared in cooperation with Rutgers Univ.,
submitted by American Cyanamid Co., Princeton, N.J.: CDL:109804-D)
00082517 O'Grady, J.J.; Winter, G.D.; Vidone, L.B.; et al. (1959) Dodecylguanidine
Acetate: Two-year Feeding to Rats: Report No. 59-1. Final rept.
(Unpublished study received Feb 25, 1959 under PP0211; submitted by
American Cyanamid Co., New York, N.Y.; CDL: 090238-F)
00089415 American Cyanamid Company (1958) Dodecylguanidine Acetate Residues
from Apples. (Unpublished study received Oct 17, 1958 under
PP0211; CDL:090237-A)
00089417 American Cyanamid Company (1958) Dodecylguanidine Acetate Residues
from Sour Cherries: Summary. (Compilation; unpublished study
received Oct 17, 1958 under PP0211; CDL:090237-D)
00089881 American Cyanamid Company (1960) Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Method Used: Cyprex 65-W. Includes method D 20 e dated Jul 2,
1958. (Compilation; unpublished study received Aug 7, 1960
under PP0324; CDL:-090352-A)
00090258 American Cyanamid Company (1964) Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Method Used: Cyprex. (Compilation; unpublished study received
May 5, 1964 under PP0416; CDL:090450-B)
-1-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Dodine Standard
MRID CITATION
00093588 Orloski, E.J.; Caruso, M. (1965) Cyprex Dodine Residues in
Peaches: Report No. C-101. (Unpublished study received Jan
26, 1967 under 7F0577; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:090739-B)
00094615 Larsen, D.J. (1979) Spinach Foliar Fungicide Study. Includes
method dated Apr 17, 1978. (Unpublished study, including letter
dated Sep 25, 1979 fron R.W. Vetro to C.F. Niven, Jr., received
Feb 9, 1982 under 4E1474; submitted by Interregional Research
Project No. 4, New Brunswick, N.J.; CDL:070669-H)
00096154 Terriere, L.C.; Kiigemagi, U. (1960) Cyprex Residues on Apples.
(Unpublished study received Feb 24, 1961 under 241-12; prepared
by Oregon State Univ., Agricultural Experiment Station, Dept. of
Agricultural Chemistry, submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:026957-C)
00101353 American Cyanamid Co. (19??) Chanistry of Dodecylguanidine Ace-
tate. (Compilation; unpublished study received Jul 14, 1969
under 1730-22; CDL:006583-A)
00101357 American Cyanamid Co. (1962) Residues of Cyprex in Peaches and
Cherries. (Compilation; unpublished study received Nov 29,
1962 under 241-51; CDL:026949-A)
00101358 American Cyanamid Co. (1967) Residues of Dodine in Pecans and
Peanuts. (Compilation; unpublished study received Oct 12, 1967
under 8F0655; CDL:091143-A)
00101362 American Cyanamid Co. (19??) General Properties: Cyprex. (Un-
published study received Aug 7, 1960 under PP0324; CDL-.092606-A)
00101371 Interregional Research Project No. 4. 1974. The results of tests
on the amount of dodine residue remaining in or on spinach, including
a description of the analytical method used. (Compilation; unpublished
study received Feb. 28, 1974 under 4E1474; CDL:093922-A)
00101372 Allen, J.; Caterson, C.; Johnson, E. (1978) Mutagenicity Testing
of Cyprex/Melprex Dodine in the Ames Bacterial Test: Project
No. 0-796. Final rept. (Unpublished study received Jan 24,
1979 under 241-51; submitted by American Cyanamid Co., Prince-
ton, NJ; CDL:097763-A)
00101373 Interregional Research Project No. 4 (1975) Cyprex Residues on
Spinach. (Compilation; unpublished study received May 12, 1975
under 4E1474; CDL:098104-A)
00101385 Steller, W.; Klotsas, K.; Kuchar, E. (1960) Colorimetric esti-
mation of dodecylquanidine acetate residues. Agricultural
and Food Chemistry 8(6):460-464. (Also in unpublished sub-
mission received on unknown date under unknown admin, no.; sub-
mitted by American Cyanamid Co., Princeton, NJ; CDL:125047-A)
-2-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Dodine Standard
MRID CITATION
00101393 American Cyanamid Co. (1958) Results of Tests on the Amounts of
Residues of Cyprex Dodine Remaining on Apples. (Compilation;
unpublished study received Feb 8, 1960 under unknown admin, no.;
CDL:125134-B)
00101397 Howard, D.; Johnston, C. (1971) Cytox 2160: Safety Evaluation by
Single Oral Administration to Bobwhite Quail. (Unpublished
study received Oct 19, 1971 under 1730-22; prepared by Woodard
Research Corp., submitted by American Cyanamid Co., Consumer
Products Research Div., Wayne, NJ; CDL:130888-A)
00101398 Macek, K.; Sleight, B.; Shaffer, C. (1971) The Acute Toxicity of
Cytox 2160 (ST 45093) to Bluegill (Lepomis macrochirus) and
Rainbow Trout (Salmo gairdneri). (Unpublished study received
May 10, 1971 under 1730-22; prepared in cooperation with Bio-
nomics, Inc., submitted by American Cyanamid Co., Consumer Prod-
ucts Research Div. , Wayne, NJ; CDL:131387-A)
00101403 American Cyanamid Co. (19??) Cyprex Formulations: Chemical Study.
(Compilation; unpublished study received Jun 28, 1978 under
241-51; CDL:234201-A)
00106142 Gabriel, K. (1972) Subacute Toxicity to Avian Species—Dietary
LC50--8 Day Protocol. (Unpublished study received Jan 15, 1973
under unknown admin, no.; prepared by Biosearch, Inc., submitted
by Betz Laboratories, Inc., Trevose, PA; CDL:132186-A)
00123854 Laub, D. (1979) Static, Acute Aquatic Toxicity Tests—Lepomis
macrochirus, Salmo gairdneri: Slime-Trol RX-31. (Unpub-
lished study received Jun 22, 1979 under 3876-112; submitted by
Betz Laboratories, Inc., Trevose, PA; CDL:241186-A)
00124280 Fischer, J. (1983) Toxicity Data: Dodine: Report No. A83-1.
(Unpublished study received Jan 24, 1983 under 241-269; sub-
mitted by American Cyanamid Co., Princeton, NJ; CDL:249349-A)
00143591 American Cyanamid Co. (1983) [Product Chemistry Data on Cyprex
Technical]. Unpublished compilation. 18 p.
00157386 Kligman, A. (1977) The Evaluation of Irritating and Sensitizing
Properties of Cytox 2160 by Means of the Modified Draize-Shelan-
ski Patch Test: Protoco] 3422. Unpublished study prepared by
Ivy Research Labs, Inc. 7 p.
-3-
-------
0KB Approval No. 2070-0057 (Expires 11/30/89)
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With raipKt to the rtquirimtnt to wbmit "generic" date Imposed by the FIFRA action 3(C)(2)(B) notice contained in thi referenced
Guidance Document, I em responding in thi following mannir.
D1. I will wbmit data in a timely mennar to satisfy tha following requirements. If tha tut procedures I will urn daviata from (or ara not
spacifiad in) tha Registration Guidalinas or tha Protocols contained in tha Raports of Expert Groups to tha Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into en agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The teats, end eny required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
O 3. I enclose a completed "Certification of Attempt to Enter Into en Agreement with Other Registrants for Development^ Data" with
respect to the following data requirements:
D 4. I request that you emend my registration by deleting the following uses (this option is not available to applicants for new products):
D 6. I request voluntary cancellation of the registration of this product (This option is not availeble to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
*'A Perm MtO>1 (IMS)
-------
OMB Approval No. 2070-0057 (Expires 11/30/89)
(To Qtmllfy, drtlfv ALL fourtttmtl
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME Of FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included en offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iil) if final agreement on all terms could not be reeched otherwise. This offer wet made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
lowever, none of those firm(s) accented mv offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B>. (This statement
dom not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
NAME
EFA
(1042)
SIGNATURE
DATE
-------
FORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s):
(2) Each active ingredient listed in paragraph (1) is present solely
as the result 'of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, Which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling
-------
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXIOOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flamnability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dental
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am conplying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
|