United Sum
Environmental Protection
Agency
Office of
Pesticides and Tonic Substances
Special Pesticide Review OMsioa
December 1980
Washington. DC 20460
Pesticide:
N,N-diethyl-m-toluamide
(Deet)
Pesticide Registration
Standard
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DEBT
Pesticide Registration Standard
Joseph Panetta
Owen Seeder
Lynn F. Brown
Tbnda Hicks
Richard Johnson
Jeff Remoter
Cathy Kessler
Gary Otakie
Wendy We instain
William Boodee
Roger Gardner
Franklin D.R. Gee
Carolyn Gregorio
Raymond Kent
John Leitzke
Unda.Priddy
Arthur Schlosser
December 1980
Team Leader (SPHD)
Project Manager (SPRO)
Project Manager (SPRD)
Secretary (SPRD)
Project, Manager (SPRD)
Section Head (SPRD)
Student Assistant (SPRD)
Project Manager (SPRD)
Student Assistant (SPRD)
Chemist (HED).
Toxicologist (HED)
Product Manager (RD)
Toxicologist (HED)
Residue Chemist (HED)
Wildlife Biologist (HED)
Entomologist (BFSD)
Ehvironoental Chemist (HED)
Office of Pesticides and Toxic Substances
Environmental Protection Agency
401 M Street, SW
Washington, DC 2C460
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TABLE CF CONTENTS
I. Haw to Register Under a Registration Standard *
II. Regulatory Position 7
A. Introduction 7
B. Background 7
C. Regulatory Decision 7
D. Terms and Conditions of Registration 9
III. Product Chemistry -
A. Introduction i.. 24
B. Disciplinary Review 24
1. Chemistry Profile
2. Generic Data Gaps
3. Required Labeling
C. Topical Discussions 25
IV. Environmental Fate
A. Disciplinary Review ... 30
1. Use Profile
2. Environmental Fate Profile
3. Exposure Profile
4. Data Gaps
5. Required Labeling
B. Topical Discussions 34
V. Toxicology
A. Disciplinary Review 36
1. Toxicology Profile
2. Human Hazard Assessment
3. Data Gaps
4. Required Labeling
B. Topical Discussions 40
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VI. Ecological Effects. .-. 63
A. Disciplinary Review
1. Ecological Effects Profile and Hazard Assessnent
2. Data Gaps
3. Required Labeling
3. Topical Discussions .
VII. Efficacy 6S
A. Introduction .-. 6S
B. Efficacy Assessment ... .. 6S
C. Data Gaps 71
D. Labeling 72
VIII. Case Bibliography .'. 81
,. Guide to the Use of the Bibliography 31
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I. HDW TO RE5ISTER UNDER A REGISTRATION STANDARD
Organization of the Standard
Purpose of the Standard
Requirement to Re-register Uider the Standard
"Product-Specific* Data and "Generic" Data
Data Compensation Requirements under FIFRA 3(c) (1) (D)
Amendments to the Standard
Organization of the Standard
This first chapter explains the purpose of a Registration Standard and
suonarizes the legal principles involved in registering or re-registering under
a Standard. The second chapter sets forth the requirements that must be met to
obtain or retain registration for products covered by this particular
Registration Standard. In the remaining chapters, the Agency reviews the
available data by scientific discipline, discusses the Agency's concerns with
the identified potential hazards, and logically develops the conditions and
requirements that would reduce those hazards to acceptable levels. _ .
Purpose of the Standard
Section 3 of die Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) provides that "no person in any State may distribute, sell, offer for
sale, hold for sale, ship, deliver for shipment, or receive (and having so
received) deliver or offer to deliver, to any person any pesticide which is not
registered with the Administrator [of EPA]." To approve the registration of a
pesticide, the Administrator must find, pursuant to Section 3(c)(5) that:
"(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to be submitted comply with
the requirements of this Act;
(Q it will perform its intended function without unreasonable adverse
effect on the environment; and
(D) when used in accordance with widespread and commonly recognized
practice it will not generally cause unreasonable adverse effects on
the environment."
In making these findings, the Agency reviews a wide range of data which
registrants are required to sutmit, and assesses the risks and benefits
associated with the use of the proposed pesticide. But the established
approach to making these findings has been found to be defective on two counts:
First, EPA and its predecessor agency, the United States Department of
Agriculture (USDA), routinely reviewed registration applications on a 'product-
by-product1 basis, evaluating each product-specific application independently.
In the review of products containing similar components, there was little
opportunity for a retrospective review of the full range of pertinent data
available in Agency files and in the public literature. Thus the 'product-by-
product' approach was often inefficient and sometimes resulted in inconsistent
or incomplete regulatory judgments. Second, over the years, as a result of
continuing advances in scientific knowledge, methodology, and policy, the data
base for many pesticides came to be considered inadequate by current scientific
and regulatory standards. Given the long history of pesticide regulation in
several agencies, it is even likely that materials may have been lost from the
data files. When EPA issued new requirements for registration in 1975 (40 CFR
10, 1978 and 43 FR 37336, August 2, 1978), many products that had already been
registered for years were being sold and used without the same assurances of
human and envircnnental safety as was being required for new products. Because
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of this inconsistency, Congress directed .EPA to re-register all previously
registered products, so as to bring- their registrations and their data bases
into compliance with current requirements [See FIFRA Section 3(g)].
Facing the enormous job of re-reviewing and calling-in new data for the
approximately 35,000 current registrations, and realizing the inefficiencies of
the 'product-by-product' approach, the Agency decided that a new, more
effective method of review was needed.
A new review procedure has been developed. Under it, EPA publishes -
docunents called Registration Standards, each of which discusses a particular
pesticide active ingredient. Each Registration Standard, summarizes, all the
data available to the Agency on a particular active ingredient and its current
uses, and sets forth the Agency's comprehensive position on the conditions and
requirements for registration of all existing and future products which contain.
that active ingredient. These conditions and requirements, all of which must
be met to obtain or retain full registration or re-registration under Section
3(c)(5) of FIFRA, include the submission of needed scientific data vhich the.
Agency does not now have, compliance with standards of toxicity, composition,
labeling, and packaging, and satisfaction of the data compensation provisions
of FIFRA Section 3(c) (1) (D).
The Standard will also serve as a tool for product classification. As part
of the registration of a pesticide product, EPA may classify each, product for
•general use", or "restricted use" when some special regulatory restriction is.
needed to ensure against unreasonable adverse effects to man or the environ-
ment. Many such risks of unreasonable adverse effects can be lessened if
expressly-designed label precautions are strictly followed. Thus the special
regulatory restriction for a "restricted use" pesticide usually requires that
an applicator be certified by the state or Federal government as being
competent to use pesticides safely, responsibly, and in accordance with label
directions.A restricted-use pesticide can have other regulatory restrictions
[40 CFR 162.11(c)(5)] instead of, or in addition to, the certified applicator
requirement. These other regulatory restrictions may include such actions as
seasonal or regional limitations on use, or a requirement for the monitoring of
residue^evels after use. A pesticide classified for "general use," or not
classified at all, is available for use by any individual who is in compliance
with state or local regulations. The Registration Standard review compares
information about potential adverse effects of specific uses of the pesticide
with risk criteria listed in 40 CFR 162.11(c), and thereby determines whether a
product needs to be classified for "restricted use." If the Standard does
classify a pesticide for "restricted use," this determination is stated in the
Chapter 2.
Requirement to Re-register Under the Standard
FIFRA Section 3(g), as amended in 1978, directs EPA to re-register all
currently registered products as expeditiously as possible. Congress also
agreed that re-registration should be accomplished by the use of Registration
Standards.
Each registrant of a currently registered product to which this Standard
applies, and who wishes to continue to sell or distribute his product in
commerce, must apply for re-registration. Each application must contain
proposed labeling that complies with this Standard.
EPA will issue a notice of intent to cancel the registration of any
currently registered product to which this Standard applies if the registrant
fails to comply with the procedures for re-registration set forth in the
Guidance Package which accompanies this Standard.
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"Product-Specific* Data and Tjeneric" Data
In the course of developing tills Standard, EPA has determined the types of
data needed for evaluation of the properties and effects of products to which
the Standard applies, in the disciplinary areas of Product Chemistry, Environ-
mental Fate, Toxicology, Residue Chemistry/ and Ecological Effects. These
determinations are based primarily on the data Guidelines proposed in 1978
(43 ER 29686, July 10, 1978, and 43 FR 37336,. August 2, 1978), as applied to
the use patterns of the products to which this Standard applies. Where it
appeared that data from a normally applicable Guidelines requirement was
actually unnecessary to evaluate these products, the Standard indicates that
the requirement has been waived. Ch the other hand, in seme cases studies not
required by the Guidelines may be needed because of the particular conpu-
sitionor use pattern of products the Standard covers; if so, the Standard
explains the Agency's reasoning. Data guidelines have not yet been proposed
for the Residue Chemistry discipline, but the requirements for such data have -
been in effect for some time and are, the Agency believes, relatively familiar
to registrants. Data which we have found are needed to evaluate the registra-
bility of some products covered by the Standard may not be needed for the
evaluation of other products, depending upon the composition, formulation type,
and intended uses of the product in question. The Standard states which data
requirements apply to which product categories (see the second chapter). The
various kinds of data normally required for registration of a pesticide product
can be divided into two basic groups:
(A) data that is •product-specific,* i.e., data that relates only to the
properties or effects of a product with a particular composition (or a
group of products with closely similar composition); and
(B) "generic" data that pertains to the properties or effects of a
particular ingredient, and thus is relevant to an evaluation of the
risks and benefits of all products containing that ingredient (or all
such products having a certain use pattern), regardless of any such
product's unique composition.
The Agency requires certain •product-specific* data for each product to
characterize the product's particular composition and physical/chemical
properties (Product Chemistry), and to characterize the product's acute
toxicity (which is a function of its total composition). The applicant for
registration or re-registration of any product, whether it is a manufacturing-
use or end-use product, and without regard to its intended use pattern, must
submit or cite enough of this kind of data to allow EPA to evaluate the
product. Fbr such purposes, "product-specific" data on any product other than
the applicant's is irrelevant, unless the other product is closely similar in
composition to the applicant's. (Vhere it has been found practicable to group
similar products for purposes of evaluation, with a single set of tests, of all
products in the group, the Standard so indicates.) "Product-specific" data on
the efficacy of particular end-use products is also required where the exact
formulation may affect efficacy and where failure of efficacy could cause
public health problems.
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AH other data needed .to- evaluate, pesticide products concerns the
properties or effects of a particular ingredient of products (normally a
pesticidally active ingredient, but in seme cases a pesticidally inactive, or
•inert," ingredient). Some data in this "generic* category are required to
evaluate the properties and effects of all products containing the ingredient
(e.g., the acute LD-50 of the active ingredient in its technical or purer
grade; see proposed 40 CFR 163.81-1(a), 43 PR 37355].
Other "generic" data are required to evaluate all products which both
contain a particular ingredient and are intended for certain uses (see proposed
40 CFR 163.82-1, 43 ER 37363, which requires subchronic oral'testing of the
active ingredient with respect to certain use patterns only). Where a
particular data requirement is use-pattern dependent, it. will apply to each
end-use product which is to be labeled for that use pattern (except where such
end-use product is formulated from a registered manufacturing-use product
permitting such formulations) and to each msnufacturing-use product with
labeling that allows it to be used to make end-use products with that use
pattern. Thus, for example, a subchronic oral dosing study is needed to
evaluate the safety of any manufacturing-use product that legally could be used
to make an end-use, food-crop pesticide. But if an end-use product's label
specified it was for use only in ways that involved no food/feed exposure and
no repeated human exposure, the subchronic oral dosing study would not be
required to evaluate the product's safety; and if a manufacturing-use product's
label states that the product is for use only in making end-use products not
involving food/feed use or repeated human exposure, that subchronic oral study
would not be relevant to the evaluation of the manufacturing-use product either.
If a registrant of a currently registered manufacturing-use or end-use
product wishes to avoid the costs of data compensation [under FIFRA Section
3(c) (1) (D)] or data generation [under Section 3(c) (2) (B)] for "generic* data
that is required only with respect to some use patterns, he may elect to delete
those use patterns from-his labeling at the time he re-registers his product.
M applicant for registration of a new product under this Standard may
similarly request approval for only certain use patterns.
Data Compensation Requirements under FIFRA 3(c) (1) (D)
Under FIFRA Section 3(C) (1) (D), an applicant for registration, re-registration,
or amended registration must offer to pay compensation for certain existing
data the Agency has used in developing the Registration Standard. The data for
which compensation must be offered is all data which is described by the
following criteria:
(1) the data were first submitted to EIA (or to its predecessor agencies,
USEA or FDA), on or after January 1, 1970;
(2) the data were submitted to EEA (or USEA or FDA) by some other applicant
or registrant in support of an application for an experimental use
permit, an amendment adding a new use to a registration, or for re-
registration, or to support or maintain in effect an existing
registration;
(3) the data are relevant to the Agency's decision to register or re-
register the applicant's product under the Registration Standard,
taking into account the applicant's product's composition and
intended use pattern(s);
(4) the data are determined by EEA to be valid and usable in reaching
regulatory conclusions; and
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(5) the data are not those for which the applicant has been exempted by
FIFRA Section 3(c) (2) (D) from the duty to offer to pay compensation.
(This exemption applies to the "generic" data concerning the safety of
an active ingredient of the applicant's product, not to "product
specific* data. The exemption is available only to applicants who
_ propose to purchase a registered pesticide from another producer in
order to formulate such purchased pesticide into an end-use product.)
An applicant for re-registration of an already registered product under
this Standard, or for registration of a new product under this Standard,
accordingly must determine which of the data used by EPA In developing the
Standard must be the subject of an offer to pay compensation, and must submit
with his application the appropriate statements showing his compliance with
FIFRA.Section 3(q (1) P).
An applicant would never be required to offer to pay for "product-specific"
data submitted by another firm. In most cases, data which are specific to
another firm's product will not be useful to the Agency in determining whether
the applicant's product is registrable. There may be cases, however, where
because of close similarities between the compositions of two or more products,
another firm's data may suffice to allow EPA to evaluate seme or an of the
"product specific" aspects of the applicant's product. In such a case, the
applicant may choose to cite that data instead of submitting data from tests on
.his own product. If he chooses that option, he would have to comply with the
offer-to-pay requirements of Section 3(C) (1)(D) for the data.
Each- applicant for registration or re-registration of a manufacturing-use
or end-use product who is not exempted by FIFRA Section 3(c) (2)(D), must comply
with the Section 3(c) (1) (D) requirements with respect to each item of "generic"
data that relates to his product's intended uses.
A detailed description of the procedures an applicant must follow in
applying for re-registration (or new registration) under this Standard is found
in the Guidance Package for this Standard.
Obtaining Data to Fill "Data Gaps"; FIFRA 3(c) (2) (B)
Seme of the kinds of data EPA needs for its evaluation of the properties
and effects of products to which this Standard applies have never been
submitted to the Agency (or, if submitted, have been found to have deficiencies
rendering them inadequate) and have not been located in the literature search
that EPA conducted as part of preparing this Standard. Such instances of
missing but required data are referred to in the Standard as "data gaps".
FIFRA Section 3(c) (2)(B), added to FIFRA by the Congress in 1978,
authorizes EPA to require registrants to whom a data requirement applies to
generate (or otherwise produce) data to fill such "gaps" and submit these data
to EPA. EPA must allow a reasonable period of time for this to be
accomplished. If a registrant fails to take appropriate and timely steps to
fill the data gaps identified by a Section 3(c)(2)(B) order, his product's
registration may be suspended until the data are submitted. A mechanism is
provided whereby two or more registrants may agree to share in the costs of
producing data for which they are both responsible.
The Standard lists the "generic" data gaps and notes the classes of
products to which these data gaps pertain in its sunnary second chapter.
The Standard also points out that to be registrable under the Standard, a
product must be supported by certain required "product-specific" data.
As part of the process of re-registering currently registered products, EPA
will issue Section 3(c> (2)(B) directives requiring the registrants to take
appropriate steps to fill all identified data gaps — whether the data in
question is "product-specific* or "generic" — in accordance with a schedule.
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Persons who wish to obtain registrations for new products under this
Standard- will be required to submit (or cite) sufficient "product-specific"
data before their applications' are approved. Upon registration/ they will be
required under Section 3(c)(2)(B) to take appropriate steps to submit data
needed to fill "generic* data gaps. (We expect they will respond to this
requirement by entering into cost-sharing agreements with other registrants who
previously have been told they must furnish the data.) The Guidance Package
for this Standard details the steps that must be taken by registrants to comply
with Section 3(c)(2)(B).
Amendments to the Standard
Applications for registration which propose uses or formulations that are
not presently covered by the Standard, or which present product compositions,
product chemistry data, hazard data, toxicity levels, or labeling that do not
meet the requirements of the Standard, will automatically be considered by the
Agency to be requests for amendments to the Standard. In response to such .
applications, the Agency may request additional data to support the proposed
amendment to the Standard, or may deny the application for registration on the
grounds that the proposed product would cause unreasonable adverse effects to
the environment. In the former case, when additional data have been
satisfactorily supplied, and providing that the data do not indicate the
potential for unreasonable adverse effects, the Agency will then emend the
Standard to cover the new registration.
Each Registration Standard is based upon all data and information available
to the Agency's reviewers on a particular date prior to the publication date.
This "cut-off" date is stated at the beginning of the second chapter. Any
subsequent data submissions and any approved aoencments will be incorporated
into the Registration Standard by means of addenda, copies of which are
available for inspection at EPA in Washington, O.C., and may be requested from
the Agency. When all the present "data gaps" have been filled and the
submitted data have been reviewed, the Agency will revise the Registration
Standard. Thereafter, when, the Agency determines that the internally
maintained addenda have significantly altered the conditions for registration
under the Standard, the document will be updated and re-issued for publication.
While the Registration Standard discusses only the uses and hazards of
products containing the designated active ingredient(s), the Agency is also
concerned with the potential hazards of seme inert ingredients and impurities.
Independent of the development of any one Standard, the Agency has initiated
the evaluation of seme inert pesticide ingredients. Where the Agency has
identified inert ingredients of concern in a specific product to which the
Standard applies, these ingredients will be pointed out in Qiapter 2.
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IX. REGULATORY POSITION
A. Introduction
This chapter is the central part of the Registration Standard. It presents the
Agency's regulatory position based on an evaluation of all registered products
containing Deet as the sole active ingredient. After briefly discussing
background information on the regulatory history, uses and production of Deet,
this chapter explains the Agency's major concerns about the toxicology of Deet,
the regulatory actions which will be pursued, and the criteria by which .
applications for registration of Deet products will be approved. Thus, this
chapter contains all of the Agency's requirements or continued registration of
Deet products and new product registrations that are covered by the Standard.
Detailed analyses of the data upon which this regulatory position is based are
presented in each of the disciplinary chapters. III through VII.
B. Background - .......
•Deet" is the cannon name for N,N-diethyl-m-toluamide, a multi-purpose insect
repellent registered for direct application to human skin, clothing, household
pets, tents and bedrolls and screens. Deet is a rather unique pesticide,
because it is applied directly to the human body for purposes of repelling
insects. It was developed and patented by the U.S. Army in 1946 for use by
military personnel in insect-infested areas. Because Deet was recognized as
one of the few products effective against mosquitoes and biting flies, it was
registered for "domestic use" (use by the general public in the U.S.) in 1957.
Subsequently, all Deet-containing products have been registered without any
restrictions as to the amount or frequency of application to the body.
Deet products currently available to the public are marketed in a variety of
liquids, foams, lotions, sprays, and impregnated materials. Formulations
registered for direct application to human skin contain from 11.27% to 99.9%
Deet as the active ingredient.
C. Regulatory Decision
A review of the very limited data available as of October 24, 1980 indicates
that the criteria for unreasonable adverse effects have not been met for
products containing Deet (40 CFR 162.11[a]). However, the data do suggest that
more complete testing must be required to satisfy specific health effects
concerns revealed during the review of Deet.
First, the Deet data base is very incomplete, particularly in the area of
chronic effects studies. Further, the available chronic toxicity data were
inadequate to assess the long-term effects of Deet, i.e. oncogenicity,
teratology, reproduction and mutagenicity. Several supplementary studies
(dominant lethal mutagenicity, oral teratology, subchronic inhalation) indicate
possible reproductive toxicity. Although the data are only suggestive it is
imperative to conduct the necessary studies to resolve the possibility of
adverse effects.
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A second major concern is that because Deet is. applied directly to the hunan.
body, an individual's exposure-can be very high, especially vhen applications
are repeated daily or even more frequently 'over a period of tine. The
available data indicate that about 38% of the population uses an insect
repellent. Of this group, many use Deet only occasionally. However, some
people apply large doses daily (up to 117.0 mg/kg/day) and repeatedly
throughout part of the year. Exposures are even higher for those involved in
outdoor work including military personnel (10.7 mg/kg/day up to 60 times per
year.)
This profile of widespread and often repeated use creates a high potential .
for unreasonable adverse effects, especially considering the absence of
many chronic studies and considering the questions raised above by existing
studies.
Of additional concern is that several acute eye irritation studies .....
demonstrate that certain Oeet products are severe eye irritants. Eye
irritation studies using technical grade (99.9%) Deet demonstrate that it
produces temporary corneal opacity (clouding of the eye) in rabbits. Based on
these results, the Agency determines that products containing 99.9% Oeet are
not registerable for domestic use (see 40 CFR 162.11 (c)(2)(i)(A)). Because
the Agency has no eye irritation studies for products containing from 30% to
99.9% Deet, these data must be provided as soon as possible to determine if
public health risks exist from use of these products.
Further, an Agency review of Deet confidential Statements of Formula shows
that many registrants have not submitted revised Statements demonstrating that
Freon propellants have been removed. The Agency reminds registrants that
Freons nave been banned for use in Oeet pressurized liquids because they cause
a depletion of the oaone layer (43 FR 11318). Products containing Freons are
therefore not registerable under this Standard.
Finally, toxicologic concerns have emerged as to the health, effects of
pesticides in children. These concerns justify the need to study the dermal
absorption rate of Deet in laboratory animals to determine if there is greater
absorption through the skin of children than adults.
Based on all these concerns, the Agency has concluded that the following
regulatory actions must be initiated immediately:
1. All basic chronic and acute toxicology data for technical and
formulated Deet, as veil as additional special studies must be submitted.
These studies are listed in Tables 1 and 2; protocols for the special
studies are available from the Agency. They must be submitted according to
the stringent, accelerated schedule shown in the tables.
2. The Agency will prohibit registration or continued registration
formulated Deet product vhich demonstrates acute eye irritation effects
of corneal opacity, or eye irritation persisting for 7 days. These
products currently include formulations containing 99.9% Deet. The Agency
will not change or reduce the requirements for eye irritation testing of
Deet, because of its intended use directly on hunan skin.
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3. Deet products are registerable only if all of the terms and conditions
of this Standard are met. These conHItions are presented in the remainder
of this chapter. Products not brought into compliance with the require-
ments of this Standard will be subject to suspension and/or cancellation.
New products registered under this Standard are subject to the sane
conditions.
4. This Standard will be effective immediately. It will be appropriately
revised after ell required data have been reviewed and evaluated by the
Agency. The Standard may be amended to add certain new uses and
formulations not currently registered.
D. Terms and Conditions of Registration
Applicants for registration or continued registration of Deet products subject
to this Standard must comply with all terms and conditions described in this
'Standard, including commitment to fill data gaps according to the schedule
specified in Tables 1 and 2. When applicable (see Chapter 1}, applicants must
offer to pay compensation to the extent required by Sections 3(c) (1) (D) and
3(c) (2) (D) of the Federal Insecticide, Fungicide and Rodenticide Act [FIFRA] as
amended, 7 U.S.C. 136 (c) (1) (D) and 136 (c) (2) (D). The following registrants
have submitted data in support of Deet registrations, and have not waived their
rights to compensation for these data: Cutter Laboratories; Rhone-Poulenc Co.;
Charles Pfizer and Company, Inc.; Mclaughlin Gormley King Co.; S.C. Johnson and
Sons, Inc.; Straight Arrow Co and; Tillar Enterprises.
Following is a summary of the terms and conditions of this standard, including
the areas of product composition, acute toxicity, use sites, data requirements
and labeling.
Product Composition Standard
a. Technical Deet
To be registered under this Standard, technical Deet must comply with the
product composition standard developed in the Product Chemistry chapter.
Technical Deet must therefore contain a minimum of 95% active ingredient, with
appropriate certification of upper limits of unintentional ingredients as
defined in Chapter 3.
b. Formulated Deet
The following types of formulated Deet, with less than 95% active ingredient,
and acceptable acute toxicity ratings are acceptable under this Standard:
Ready-to-Use Solution
Pressurized Liquid
Impregnated Material
Applicants for registration of these types of formulations must certify upper
limits of impurities as described in Chapter 3, as well as upper and lower
limits of inert ingredients.
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The Agency finds the. inert ingredient, Ereon, indentified. through a review, of
Confidential Statements of Ebrmula, unacceptable for use in Deet formulations
because of the potential to cause depletion of the oaone layer of the
atmosphere (43 PR 11318). *
Acute Toxicity Limits
1. Technical Deet
Because technical Deet products are only for manufacturing use, there are no
established acute taxi city limits for technical Deet. -
2. Formulated Deet
To be registered for domestic use under this Standard, in accordance with FIFRA
Section 3(d)(1)(C)(i), formulated (see Table 24 ) Deet products must have
ratings no higher than Toxicity Category III or IV for each, of the following
acute effects: ' .-•
Acute Oral Toxicity
Azute Dennal Toxicity
Acute Inhalation Toxicity
Primary Dennal Irritation
Additionally, formulated Deet products must not demonstrate eye irritation
persisting for seven days or any cornea! opacity in test animals.
Use Patterns
1. Technical Deet
To be registered under this Standard, technical Deet products may be
repackaged or formulated only into end-use, insect repellents for domestic
use.
2. Formulated Deet
To be registered under this Standard, formulated Deet products shall be
labelled for use only as insect;repellents for application to human skin,
household pets, clothing, bedding, tents, and screens. Application to food or
livestock shall be prohibited by label direction.
Data Requirements
Applicants for registration of technical or formulated Deet products must cite
or submit the data listed in Tables 1 and 2, respectively, by specified due
dates. Data in this Standard that satisfy registration requirements may be
cited, if the applicant establishes that the proposed product is substantially
similar (as determined by percentage of active and inert ingredients, manu-
facturing impurities and different uses) to another product for which the
Agency has received acceptable data. If data in this Standard are cited,
compensation must first be offered to the sutmittar(s) of the data as explained
in Chapter 1. The Agency will examine both active and inert ingredients to
determine if products are similar. In front of each requirement in Tables 1
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and 2 is listed the section of the Proposed Guidelines (43 ER 29696, July 10,
1978; and 43 FR 37336, August 22, 1978) which describe that type of data and
when it is required. Applicants must submit, solely or through joint
agreement, all information in the tables identified as data gaps.
Applicants will not be required to submit residue chemistry data because Deet
has no .food uses and is.not expected .to. occur indirectly as a food residue......
Required Labeling
All technical and formulated Deet products must bear appropriate labeling as
specified in the Guidance Package which accompanies this Standard. .
1. Technical Deet
All technical Deet products must list on the label the intended end-use of
formulated products produced from the technical products. Therefore, in
addition to basic labeling, all technical Deet product labels must bear the
following statement:
."For formulation into Old-Use Insect Repellent Products Intended Only for
Domestic, Nonfood Use.*
2. Formulated Deet
In addition to the basic labeling requirements, to reduce the possibility of
inadvertent application to food and livestock, all formulated Deet products
must bear the following statement:
j "Do Not Apply Near Food or to Livestock"
All formulated Deet products must bear an appropriate statement of practical
first-aid treatment in case of accidental ingestion or eye contact.
For formulated Deet products which present label claims that the product is
effective against insects which might affect public health, the Agency will
require registrants to submit data to support these claims. All labels which
claim that Deet repels the following pests, must be supported by company data
or published literature:
biting flies (black fly, sandfly, horsefly and Ceratopogonid species only)
chiggers
deerflies
fleas
leaches
mosquitoes
stableflies
ticks
Data required by the Agency in support of Deet's efficacy are listed in
Table 3. These data are explained in detail in Chapter VII.
-------
wccycT-spBcmc DATA REQUIREMENTS PGR TECHNICAL PRODUCTS
Product-Chemistry
Table 1
Guldel Ina
Citation
163.61-3
-4
-5
-6
-7
163.61-8(1}
-fl<2>
-«<«»
-«15)
-«<6|
-an»
Name of Test
Product Identity and dis-
closure of Ingredients
Description of oqniifactur-
|ng process
Discussion on formation of
unintentional Ingredients
Declaration and certifica-
tion of Ingredients limits
Product analytical methods
and data
Color
Odor
Solubility
Stability
Octanol/Water partition
coefficient
Physical State
Composition Character 1st leg
Minium 95% active
Ingredient
•
•
•
»
•
•
•
•
•
•
Does EPA Have Da.ta
10 Satisfy This
Requirement ?
No
Yes-
Incomplete
No
Ma
No
Yes
Yes
No
Yes
No
Yes
Biblio-
graphic
Citation
— •
Pflcer, Inc., 1976
HUD |00001036|
Bogard, T., 1976
MUD 1050002014
_
_ '
-
Hercules Powder Co,
1957 MUD I0000102S
B.C. Johnson A Bon,
Inc., 1977 MUD
100001100
-
B.C. Johnson & Son,
Inc., 1977 MUD
100001100
„
Hercules Inc., 197?
MUD I 00001068
Must Data Be
Submitted Under
flfM. 3(c) (2) (B) ?
Yes
Yes
Yes
Yes
Yes
No
No
' -
No
. Yes
Na
Tims
Allowed
Before
Submission
6 nontha
24 months
24 months
6<24mos.*)
fi.inntha
^
^
6, tpnths '
_
4
_
KJ
I
* Any Impurities at 0.1% or less-Information need not be submitted until 2< mos.
-------
PRODUCT-SPECIFIC DATA RBQUIREMEl
Product Chemistry
\ TECHNICAL PRODUCTS
Table 1 Cont'd
Guideline
Citation
-8(8)
-8(9)
-«(10)
-«(U)
-8(12)
-8(13)
-8(14)
-8(15)
-6(17)
-«(18)
Name of Test
Specific
gravity
Balling point
Vapor pressure
P»
Storage stability
Flanmablllty
Oxidizing or reducing
action
Cxploslvenen
Vlficoaity
coefficient
Corrosion characteristics
Composition Characteristics
Hlnlmun 951 active
ingredient
•
•
•
•
•
•
•
•
•
Does EPA Have Data
To Satisfy This
Requirement 7
Yea
Yes
Yes
""•"
Mo
Ho
Yes
Mo
No
Yes
Yes
Biblio-
graphic
Citation
Hercules Inc.,
197? MRID
| 00001008
B.C. Johnson t
Bon, Inc., 1977
MUD 100001100
Blalne et al.,
1974 MRID
| 0S002553
-
-
B.C. Johnson
( Bon, Inc.,
1977 MRID
I 00001100
Hercules, Inc.,
1972 MRID
100001152
-
-
B.C. Johnson
* Son, Inc.,
1977 MRID
100001100
Hercules, Inc.,
1972 HMD
I 00001152
Hercules Powder
Co., 1957 MRID
1 00001025
Must Data Be
Submitted Under
PIFRA 3(c) (2) (B) ?
NO
No
No
Yes
Yes
No
Yes
Yes
No
No.
Time
Allowed
Before
Submission
^
-
« months
6 months
-
6 months
6 months
—
-
I
M
V
-------
GENERIC DATA REQUIREMENTS K» TECHNICAL PRODUCTS
?
Environmental Fata
Table 1 cont'd.
Guidelines
Citation
163. 62-7 (c)
163.62*6(9)
Sea Chapter 4
Name of Teat
Hydrolysis
Activated sludge
metabolism
Human use and
exposure data
Composition
Minima 951
active
Ingredient
•
• •
Does EPA Have Data
To Satisfy This
Requirement?
Ha
No
No
Bibliographic
Citation
-
-
-
1 Must Data Be
Submitted Under
riFRA 3
-------
GENERIC DATA REQUIREMENTS FOR
Toxicology
, ACM. PRODUCTS
Table 1 Cont'd
Guideline
Citation
163.82-3
163.82-4
163.83-1
163.83-2
163.83-3
163.83-4
163.84-2
through -4
163.85-1
Protocols
will be
furnished by
the Agency
Name of Test
Subchronlc 90-Day
Dermal Toxiclty
Subchronic inhalation
Toxiclty
Chronic Dermal
Toxiclty
Dermal Oncogenlcity
(Mouse)
Dermal Teratogeniclty
(Rat)
Dermal Reproduction
(Rat)
Mutagenicity
Metabolism
(Identification of
Metabolites)
Age-Related Dermal
Absorption Studies
(Rats)
Composition Characteristics
Minimum 95% Active Ingredient
•
•
•
•
•
•
•
•
Does EPA Have Data
to Satisfy
Ttils Requirement 7
Ho
Yes
Mo
No
Ha
Mo
No
No
No
(Special Testing)
Bibliographic Citations
-
U.S. Army* 1981
MRID | G&0002032
-
-
—
-
-
w
Must Data Be
Submitted Under
riFRA3(c)(2)(B)7
Vea
No
Yea
Yes
Yea
Yea
Yes
Yes
Yea
Time Allowed
Before
Submission
12 nontha
-
4 1/2 yeara
4 1/2 yeara
1 year
3 1/2 yeara
12 months
»
18 months
18 months
t/1
-------
GENERIC DATA REQUIREMENTS FOR TECHNICAL PRODUCTS
Toxicology
Table 1 Cont'd
Guldal Inn
Citation
163.61-1
163.81-2
163.61-3
163.81-4
163.81-S
163.81-4
Nan* of Teat
Acute Oral Toxlclty
Acute Dental Toxlolty
Acute Inhalation
Toxlclty
Primary Eye Irritation
Primary Dermal
Irritation
Dermal Sensltlzation
Composition Characteristics
Minimum 951 Active Ingredient
•
•
•
•
•
Does EPA llave Date •
to Satisfy
This Requirement ?
Yea
Yes
Yes
Yes
Yes
Yes
Bibliographic Citations
See Table 8
See Table 11
U,8. Army 1979
MRID IGS0002034 .
U.S. Army 1979
MRID fGS000282S
See Table IS
U.S. Army 1979
MRID IGS0002026
Must Data Be
Submitted Under
FIFBA3(C)(2)(B>?
No
Mo
U>
No
No
No
Tine Allowed
Before
Submission
-
-
-
-
.
-
-------
Table 1 Cont'd
GENERIC DATA REQUIREMENTS fOR . 4ICAL PRODUCTS
Ecological Effects
Guideline
Citation
163.71-1
163.72-1
163.72-1
163.72-2
Name of Teat
Avian single-dosa
oral U> 50 (wild
waterfowl, preferably
mallard duck)
Fish acute 1C SO
(coldwater species)
fish acute 1C 50
(warawater species)
Acute toxlcity to
aquatic Invertebrates
Composition
Minimum 95%
active Ingredient
•
•
•
Does EPA Have Data
to Satisfy thia
Requirement?
No
Yes
Mo
No
Bibliographic
Citation
McCann, J.A.
(1972) MUD |
00001026
-
-
Mist Data Be
Submitted Under
PIFRA 3(c)(2)(B)
Yes
No
Yes
Yes
Months Allowed
Before Submission
6 months
6 months
6 months
6 tenths
-------
DM* RHjuiReHBrrs FOR IXXIMUIATED PRODUCTS
product Chemistry
Table 2
Guideline I
Citation
1*3.41-3
-4
-5
-6
-7
163.61-8(1)
-8(?)
-8(8)
-8(9)
-8(10)
-6(11)
-8(12)
-8(13)
-8(18)
Name of Teat
Product Identity and dis-
closure of ingredients
Description of manufactur-
ing process
Discussion on formation
of unlntentlnal ingredients
Declaration and cetifica-
tlon of Ingredients Units
Product analytical nathoda
and data
Color
iOdor
(Density or specific
gravity
Boiling point
[Vapor pressure
ipil (Manufacturing-use
Iproduct and the technical)
lEtornge stability
iFlaranabillty
IVlscoslty
{coefficient (Technical)
1 Corrosion characteristics
Composition Characteristics
Any percentage active
Ingredient
•
•
•
•
f
•
Does EPA Have Data
To Satisfy This
Requirement ?
No
Mo
Mo
.
Ho
.
No
Mo
No
No
No
No
No
No
Mo
No
No
Blbllo-
. graphic
Citation
-
— • •
-
—
—
-
-
-
-
—
—
-
-
-
—
-
Must Data Be
Submitted Under
FliRA 3(c) (2)(B) ?
Yes
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
Yea
fine
Allowed
Before
Submission
6 nontha
24 nontha
24 nontha
6 (24moa.
6 nontha
6 nontha
6 nontha
6 nontha
6 nontha
fi nontha
6 tenths
6 nontha
6 nonths
6 nantha
6 nontha
• For Impurities at 0.1% or less. Information need not be submitted until 24 noa.
00
-------
ncoucr-BPBciric DATA Ra^pHorra rat FORMULATED PRODUCTS
environmental fata
Table 2 cont'd
Guideline
Citation
163.62-7 (o)
Mama of Teat
Hydrolysis
Composition Characteristics
Any percentage
active Ingredient
Does EPA Have Data
to Satisfy
This Requirement ?
No
Bibliographic
Citations
Must Data Be
Submitted Under
FIPRA 3(c)(2t(BI?
Yes
Time Allowed
Before Submission
6 nontna
-------
PRODUCT - 6PBCmC DATA REQUIREMENTS K» POHMULATED PRODUCTS
toxicology
Table 2 cont'd
Guldel Ine
Citation
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
163.81-1
163.81-2
163.81-)
163.81-4
Ham* ot Test
Acute Oral Toxic Ity
Acute Dennal Toxic I ty
Acute Inhalation
Toxic I ty
Primary Eye irritation
(Babbit)
.
Primary Dermal
Irritation (Rabbit)
Dermal Senaltlsatlon
(Guinea fig}
Acute Oral Ibxlclty
Acute Dental Toxlclty
Acute Inhalation
Tox|clty
Primary Bye Irrit-
ation (Rabbit)
Composition Characteristics
1. All Raady-to-uae
•
•
•
•
•
•
2. All PreaaurUod Liquid
•
•
f
•
Does EPA Have Data
to Satisfy
This Requirement ?
Yes
Yea
yea *
+ 6one
(Incomplete)
+ Some
(Incomplete)
t Some
(Incomplete)
Yes
Vea*
Yea
Gone
Bibliographic
Citations
WarC 1976 MUD
000illfll
Davidson 1961 MUD |
00801139
...
Davidson 1960 MUD
I 00001139
Marl 1976 MUD
I 00001181
Davidson 1969 MUD
I 00001139
Wart 1976 MUD
100001101
Ambrose 1959 MUD
1.00001051
Hart 1975a MUD 00001085
Mart 1975b MUD 00001086
toward 1971 00001080
-
Warf 1975 MUD 00001086
Ware, 1975b MUD |
00001085
Durloo t Woodward 197b
MUD 00001082
Must Data Ba
Submitted Under
riFRA 1(0(2) (B)?
No
No
Mo
Yea
.
Yea
.Yea
. No
Ma
No
Yea
Tine Allowed
Before Submission
_
- .
—
6 nantha.
i
6 nonthf
. 9 nontha.
_
-
^
6 npntho *
K)
?
1
• Ihla Infomatlon has been extrapolated (root other testa, end la adequate without further testing.
t See Chapter 5, Topical DlacuaBJona. j
-------
PRODUCT - BPECiriC DATA REQUIREMENTS FOR FORMULATED PRODUCTS
toxicology
Table 2 cont'd
Guideline
Citation
163.81-5
163.81-6
163.81-1
163.81-2
163.81-3
163.81-4
163.81-5
163.81-6
Name of Test
Primary Denial
Irritation
(Rabbit)
Dermal Senaltlsatlon
(Guinea Pig)
Acute Oral Ibxlclty
Acute Dermal Ibxlclty
Acute Inhalation
Toxlctty
Primary Eye Irritation
(Rabbit)
Primary Dermal
Irritation (Rabbit)
Dermal Senaltlzatlon
(Guinea Pig)
Composition Characteristics
Pressurized Liquid
Pressurized Liquid
3. All Impregnated Materials
•
•
•
•
•
•
Does EPA Have Data
to Satisfy
this Requirement
Some
Mo
Yea *
Yes •
Yea •
+ Borne
(Incomplete)
No
No
Bibliographic
Citations
Johnson 1972 HRID |
00001073
Mart 1975* HUD
1 00001085
Hart 1975b NRID
I 00001086s
Our loo t Woodland
9171b
MUD f 10001081
-
-
-
_
_
-
Must Data Be
Submitted Under
MFRA 3(c)<2)(B)?
Yes
.
Yes
Ho
No
tto
Yes
Yes
Yes
Tim Allowed
Bafors Submission
6 months
9 Booths
-
-
—
6 nonths
6 nonths
9 nonths
• This Information has been extrapolated from other tests, and Is adequate without further testing.
+ See Chapter 5, Topical Discussions.
i
K>
-------
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR FORMULATED PRODUCTS
Efficacy
Table 3
Target Pest
Acceptable Use
Sites
No Data Required)
i
| Use Sites for
J which Data are
Required
| Must Data be
I Submitted to Support
Duration Claims?
Biting Plies
(black flies, sand-
flies and Ceratopo-
gonidae)j
horseflies
Chiggers
Deerflies
Fleas
Leeches
Mosquitoes
Stable flies
kin
Clothing
Tents and Bedrolls
Screens
None
Skin
Skin
Clothing
Tents and Bedrolls
Skin
Clothing
Tents and Bedrolls
Skin
Clothing
Tents and Bedrolls
Skin
Clothing
Tents and Bedrolls
Screens
Skin
Clothing
Tents and Bedrolls
Outdoor Mist
Yes
Skin,Clothing, Tents j Yes
and Bedrolls, Screens)
'Clothing
*Tents and Bedrolls
Outdoor mist
Outdoor Mist
Outdoor Mist
Outdoor Mist
Outdoor Mist
Outdoor Mist
Yes
Yes
Yes
Yes
Up to 2 hrs. may
be claimed without
data for acceptable
sites.
Up to 2 hrs. may
be claimed without
data for acceptable
sites.
i
10
K>
-------
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR FORMULATED PRODUCTS
Efficacy
Table 3 Con't
Target Pest
Ticks
Acceptable Use
Sites
(No Data Required)
None
| Use Sites for
j which Data are
J Required
Skin
I Clothing
j Tents and Bedrolls
Must Data be |
Submitted to Support j
Duration Claims? I
i
I
Outdoor Mist
I
* Submit calculations which demonstrate that the product will deposit a minimum of
1 gm. Al/sq. ft., of treated material when used properly*
-------
-24-
IH. PRODUCT CHEMtSTIOf
A. Introduction
FIFRA 3(c) (2) (A) requires the Agency to establish guidelines for registering
pesticides in the United States. The Agency requires registrants to provide
quantitative data on all added ingredients, active and inert, which are equal
to or greater than 0.1% of the product by weight.
To establish the composition of products proposed for registration, the Agency
requires data and information not only on the manufacturing and formulation
processes, but also a discussion on the formation of manufacturing impurities
and other product ingredients,, intentional and unintentional. Further, to
assure that the composition of the product as marketed will not vary from the
composition evalutated at the tine of registration, applicants are required to
submit a statement certifying upper and lower composition limits for the added
ingredients, and the upper limits only for some unintentional ingredients.
Subpart 0 (43 FR 29696, July 10, 1978) suggests specific precision limits for
ingredients based on the percentage of ingredient and the standard deviation of
the analytic method.
In addition to the data on product composition, the Agency also requires data
to establish the physical and chemical properties of both the pesticide active
ingredient and its formulations. For example, data are needed concerning the
identity and physical state of the active ingredient (e.g., melting and boiling
point data, ambient vapor pressure and solubility). Data are also required on
the properties of the formulated product to establish labeling cautions (e.g.,
flammability, corrosivity or storage stability). The Agency uses these data to
characterize each pesticide and to determine its environmental and health
hazards.
B. Disciplinary Review
1. Chemistry Profile
Oeet, (N,N-diethyl-ffi-toluamide), is an all-purpose individual insect repellent
which contains a minimum of 95% of the meta isomer, the most effective form of
diethyl toluamide, as a technical active ingredient.
Technical Oeet is a nearly colorless liquid with a faint characteristic odor.
It is relatively stable, highly hygroscopic and sensitive to light. Technical
Deet is practically insoluble in water and glycerin but miscible with several
organic solvents. It has a specific gravity of 0.990-1.000 at 25 C, .
a boiling point of 111 C at 1 na Hg, and a vapor pressure of 1.67 x 10~ mm
Hg at 25°C.
Technical Deet, as it is considered under this standard, is a •manufacturing-
use product' which is intended for (re) formulation or repackaging for end use
as a •formulated product.* End use products are formulated as solutions,
lotions, gels, aerosol sprays, sticks and impregnated towelettes. Although
several multiple active ingredient products containing Oeet are currently
registered, this Registration Standard covers only those products which contain
Deet as the single active ingredient. The amount of Oeet in these products
ranges from 11.27* - 100% of the product composition by weight.
-------
-25-
2. Generic Data Gaps -
All of the generic data needed to evaluate die continued registerability of
products to which this Standard applies are listed in Tables 1 and 2, Chapter 2.
3. Required Labeling
All technical and formulated Deet products most bear appropriate product
chemistry labeling as specified in the Guidance Package which accompanies this
Standard,! * -• ~
C, Topical Discussions —
In accordance with each of the topical discussions listed below, a detailed
explanation of the mininun data that the Agency requires in order to adequately
assess a pesticide's product chemistry can be (found in the "Proposed Guidelines
for Registering Pesticides" of July 10, 1978 {43 FR Part 163.61-2).
Data Requirement
Technical Deet
Chemical Identity
Manufacturing Process
Discussion of Formation of
Pesticide Products
Percentages of Components in
unintentional Ingredients
Product Analytical Methods and Data
Physical/Chemical Properties-
Color
Odor
Solubility (in quantitative terms)
Stability
Octanol/Vteter Partition Coefficient
Physical State
Specific Gravity
Boiling Point
Vapor Pressure
Viscosity
Corrosion Characteristics
pH Measurement
Storage stability
Flanmability (flash point by closed
cup method)
b. Formulated Deet
Chemical Identity
Manufacturing Process
Discussion on formation of
Unintentional Ingredients
Percentages of Components in
Pesticide Products
Product Analytical Methods and Data
Physical/Chemical Properties-
Color
Odor
Guidelines Section
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
163.61-6(c)l
163.61-8 (c) 2
163.61-6 (c) 4
163.61-8 (c) 5
163.61-6 (c) 6
163.61-8(c)7
163. 61-8 (c) 8
163.61-8(c) 9
163.61-8(c)10
I63.61-8(c)17
163. 61-8 (c) 18
163.61-8(c)ll
163.61-8(c)12
163.61-8(c)13
163.61-3
163.61-4
163.61-5
163.61-6
163.61-7
163.61-8(c)l
163.61-8 (c) 2
-------
-26-
Hxysical State
Density or specific gravity
Boiling point
Vapor pressure
pH Measurement
Storage stability
Flanmability (flashpoint, flane
163.61-8(c)7
163. 61-8 (c) 8
163.61-8(c)9
163. 61-8 (c) 10
163.61-3(c)ll
163.61-8(c)12
163.61-8(c)13
163.61-8(c)17
163.61-8(c)18
extension)
Viscosity
Corrosion characteristics
a» Technical Deet
(1) Chemical Identity
"Deet* is die acceptable cannon name of the Etatomological Society of America
for N,N-diethyl-m-toluaHiide. The-American National Standards Institute does
not recognize Deet as the common name for NfN-diethyl-tn-toluamide.
The name "Deet" will be routinely used in this Registration Standard in lieu of
the more complex chemical name or of its trade names. Trade names for Deet
include: Metadelphene (Hercules, Inc.), Ore (S.C. Johnson & Son,Inc.),
and MSC Diethyltoluamide (McLaughlin-Gormley-King Co.).
Deet is a diethyltoluamide consisting primarily of 95% of the meta isomer; it
is an all-purpose individual insect repellent. Its molecular configuration is
shown below:
(2) Manufacturing Process
In general, the open literature describes four methods of synthesizing N,N-
diethyl-toluamides:
acid-chloridizing m-toluic acid- and .thai reacting with dlethylamine in
the presence of a catalyst in an organic solvent;
- reacting m-toluic acid and diethylamine with an appropriate catalyst in a
continuous vapor-phase;
- reacting m-toluic acid and diethylamine in an anhydrous acetic acid
medium; and
reacting m-toluic acid with diethylamine in the presence of N mono ethyl
toluamide under pressure and raised temperature.
In addition, there are several other means of producing H,N-diethyl-m-toluamide
in a laboratory; however, these procedures are not economical for continuous
large scale industrial operation.
-------
-27-
No data were submitted concerning the specific procedures, equipment and
manufacturing conditions required for commercial production of the chemical.
_. (3) Discussion on Formation of Unintentional Ingredients
The chemical reactions employed in the synthesis and purification of any active
ingredient might cause potentially harmful impurities to be-produced. The
presence of manufacturing impurities is dependent upon the nature of the
manufacturing process used. __- _• _
Data'considered as "Confidential Business Information" concerning the formation
of each substance that might reasonably be identified as present in technical
Deet were reported by Mclaughlin* Gormley, King Company and Pfizer, Inc. The
data fulfill requirements for these particular registrants. A data gap exists
for other registrants.
(4) Percentages of Components in Pesticide Products ......
Technical Deet contains a «
-------
-28-
Stabilltyr Technical Deet is a relatively stable compound. It is highly
hygroscopic and sensitive to light. When stored in a closed container
protected from light it is regarded as being stable for at least one year
(S.C. Johnson 6 Son, Inc. , 1977 MRID 100001100) .
Octanol/Vhter Partition Coefficient: No coefficient has been reported.
Physical State; Technical Deet is a liquid (Hercules, Inc., 197? MRID
100001069) . ~..-
Specific Gravity; The specific gravity of technical Deet ranges f ran
0.990 - 1.000 at 25°C (Hercules, Inc., 19?? MRID 10001068). -
Boiling Point; At 1 OB Hg. the boiling point of technical Deet is 111°C
(S.C. Johnson & Son, Inc. MRID 100001100; Blaine, R.L. et al-., 1974 MRID
WS002553) . ~~
Vapor Pressure; 1.67 x 10* on Hg at 25°C (Blaine, R.L. et al ., 1974
MRID 105002553) .
p8; none reported
Storage Stability; none reported
Flammbility; The flashpoint (open cup) for technical Deet ranges from
c< •' iy72 MRID f °0001152'" S.C. Johnson & Son,
Viscosity; The viscosity for technical Deet was reported as 13.3
centipoises at 30 C (Hercules', Inc., 1972 MRID I 00001152; S.C. Johnson &
San, Inc., 1977 MRID* 00001100).
Corrosion Characteristics; Technical Deet has no corrosive action on most
metals; however, metal containers may be corroded due to the presence of one or
more of the other ingredients in the formulated product. To prevent the possi-
bility of corrosion, a three-quarter or one-pound tin plate is reconnended.
Because excessive moisture can cause corrosion of pressurized containers, Deet
is made available almost entirely free of water. As a hygroscopic agent, Deet
should be protected from possible moisture pick-up in handling (Hercules Powder
Co. , 1957 MRID 100001025) .
Sufamittal of Sanples; Applicants for registration or reregistration will be
notified at the time of application with regard to the submission of samples.
b. Populated Deet
(1) Chemical Identity
There are no data available on the chemical identity of Deet formulations.
This constitutes a data gap.
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-29-
(2) Manufacturing Process
There are no data available on the manufacturing process of Deet formulations.
This constitutes a data gap.
(3) Discussion on Formulation of Unintentional Ingredients
Mo data have been submitted. This constitutes a data gap.
(4) Percentages of Components in Pesticides Products
Data on currently registered formulated Deet products are listed below.
Type of Formulation % Active Ingredient
Solution, Ready-to-Use 15.0-99.9%
Pressurized Liquid 12.5-75.0%
Impregnated Material - 11.7 - 38.8 % .;_•;.
The compositional data as to inert ingredients will not be discussed because of
the extensive number of Deet products. The data were given full consideration
by the Agency in developing this Registration Standard.
(5) Product Analytical Methods and Data
No method has been submitted for determining or measuring any of the impurities
in Deet products; however, the literature indicated the identification and
measurement of these impurities by thin layer and gas chrcmatography
(Voronkina, T.M., et al.., 1971, 05000597). j
Methods for detecting and measuring the active ingredient Deet in registered
products have been submitted (Sarmienta and Beroza, 1975,;05000048; Cutter
Laboratories, 1975, 00001008; Pfizer, Inc, 1976, 00001036).
(6) Physical/Chemical Properties
No data pertaining to the physical/chemical properties of Deet products were
submitted. Accordingly, none of the minimum data requirements listed at the
beginning of the Topical Discussions are satisfied and this constitutes a data
gap.
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-30-
rv. awiRDNManftL PATE
A. Disciplinary Review
1. Use Profile
The major use site for Oeet is human skin. Formulations registered for such use
are labeled to warn against contact with eyes or lips; pressurized liquids are
not to be sprayed directly, into the face. ; _.
Deet is also registered for application to household pets. Labels advise
against contact with eyes, lips and open wounds.
Clothing, tents and bedrolls nay be treated with Deet formulations registered
for these uses. Labels advise against application to rayon, spandex, dynel and
verel fabrics.
Other registered uses for Deet are application to screens and screen doors.
Labels on formulations intended for these uses caution against application to
plastics, painted surfaces and other finishes.
Although all of the above uses can occur outdoors, residues occurring in the
environment after application will be considered insignificant for purposes of
this Standard. Likewise, while Deet can be applied around food in picnic and
camping areas, residues on food items are considered insignificant for purposes
of this Standard.
*
2. Environmental Fate Profile
Registered outdoor uses of Deet are not expected to result in the -introduction
of significant amounts of this pesticide into the environment. However,
technical Deet can potentially enter the aquatic environment through* indirect
or accidental discharge into lakes, streams or wastewater treatment systems.
The data necessary, but currently not available, for an evaluation of technical
Deet's effect on the aquatic environnent are hydrolysis and activated sludge
metabolism studies; formulated Deet can also potentially enter wastewater
treatment systems and for this reason hydrolysis studies are necessary. The
only portion of an environmental fate profile necessary to this Standard is an
evaluation of these effects.
3. Exposure Profile
a. Technical Deet
For persons involved in the manufacture, handling, storage or shipment of
technical Deet, this Standard will not include an assessment of hazard because
the responsibility of establishing standards for such exposure falls within the
jurisdiction of the Occupational Safety and Health Administration.
b. Formulated Deet
Ready-to-use solutions, pressurized liquids and impregnated materials
containing Deet are registered for use on all exposed human skin areas. It is
estimated that this use accounts for 99% of the single active ingredient Deet
produced (Hales, ?. and Radtke, 1980 MRID K50002001).
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-31-
In 1978, an estimated 38% of the total U S population used an insect repellent,
although not all of these products contained Deet (S.C. Johnson and Co. 1979
MRID IGS0002002). Highest use of insect repellent was reported in the
Southwest (49%) and lowest on the Pacific Coast (27%). Of the various products
used (Deet containing and otherwise), 73% were pressurized liquids, 19% were
ready-to-use solutions, and 8% were impregnated materials. Deet concentrations
in the pressurized liquid products (the most widely used) ranged from 15 to
20%.. Based on these data, it is estimated that 22% of the general population
is exposed to pressurized liquid products that contain 15 to 20% Deet as an
active ingredient. Remaining usage is divided among other types of products
and pressurized formulations.
An Insecticide User Profile prepared by S.C. Johnson Co, Inc. in 1975 provided
most of the available data on exposure of the general population to Deet (MRID
IGS0002003). The study is not considered to be fully representative of the
U.S. population because respondents were all S.C. Johnson employees.
Nevertheless, these data are useful in the absence of other information about
the extent of use of Deet by the general population.
Based on the S.C. Johnson Go. data, average usage of Deet products by the
general population will result in an average daily exposure to active
ingredient ranging from 0.944 g (for a 20% a.i. product) to 3.5 g (for a 75%
product). This is equivalent to 13.5 - 50.6 mg/kg/day for a 70 log man and 15.7-
59 mg/kg/day for a 60 kg woman. The Johnson data also estimated usage by 90%
or less of the general population to be 1.06g and 3.98g per day for 20% and 75%
products, respectively. This is equivalent to 15.0 - 56.8 mgAg/day for a 70
kg man and 17.7-66.3 mg/kg/day for a 60 kg woman. :
Additional data provided by S.C. Johnson for a 15% pressurized liquid :
formulation related grams of product applied on the users forearms to the
number of users applying a specific amount of the product. These data, based
on a survey of 71 people, indicate that 90% of those interviewed used l.;4 grams
of product or less per forearm and 99% used 2.9 grams or less per forearm.
From these data the Agency calculated, through extrapolation, that 99% of users
are exposed to 11.0 g/day or less of formulation applied to all exposed skin.
This is equivalent to a daily exposure of 1.65 grams of Deet or 23.5 mg/kg/day
for a 70 kg man using a 15% formulation. If a 75% Deet product were used at
the 11.0 g/day rate assumed above, the exposure would 8.23 g/day of active
ingredient or 117.6 mgAg/day for a 70 kg man.
Thus, based on the S.C. Johnson survey, 1% of users may be exposed to greater
than 1.65 g/day assuming use of a 15% product. In the case of a 75% product
used at the rate of 11 g/day, exposure would be 5 times that of .the 15%
product, or 8.25 g/day/ of active ingredient.
The Agency recognizes that Deet products composed solely of technical Deet are
also available for use by the general population. Although no data are
available on use rates of these products, the Agency concludes that exposures
will be proportionately higher than those presented above if the products are
applied with the same frequency.
It must be noted that all of the above calculations reflect Deet exposure at
the surface of the skin only* Data reveiwed by Agency toxicologists, and
explained in detail in Chapter V, show that 10% of Deet applied directly to the
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-32-
body is absorbed through the skin. All of the available exposure data on the
general population and the Agency's: estimates' based on these* data are
summarized in Table 4.
Table 4
Estimated Exposure to Deet
Formulation
(% Deet)
( .
''
' 15%
I
i 20%
'
:
'..« 30%
• 50%
:
75%
:
Average Daily
Exposure
gran/day lag/kg/day
ND NO
0.944 13.50
* 13.70
1.42 20.23
2.36 33.70
3.54 50.60
* 59.00
Maximum use by 9/
90% of Subjects ^
gram/day mg/kg/day
..
NO MO
1.06 15.00
* 17.70
1.59 22.70
2.65 37.30
3.98 56.3
* 66.3
Maximum use by
99% of Subject
(Based on 11.0 gr
product/day)
grams/day mg/kg/day
__.. ... . .
1.65 23.40
ND ND
L
ND ND
ND ND
+8.23 +117.6
I/ Based on use of 16-20 g. of formulation per 4-*eek period (S.C. Johnson &
Son, Inc. 1979 MRID f GS0002002).
2/ Based on use of 48 g. of formulation per 4-week.period (S.C. Johnson &
Son, Inc. 1979 MRID K3S0002002).
* Figures assume a 60 Kg woman. All other figures assume a 70 Kg man.
Figures assume a 60 Kg woman. All other figures assume a 70 Kg man.
+ Based on extrapolation from data on application to forearm only.
ND - No data available
Several occupational groups are expected to experience exposures higher than
those of the general population. Military personnel have been identified as a
high exposure group based on an estimated usage of 1 ml of a 75% formulation
approximately 60 times per year. This is equivalent to a total annual exposure
of 43 grams of active ingredient to each of approximately 628,000 exposed
individualsr or 10.7 mg/kg/day ( Hales, Y and H.E. Radtke 1980, MRID
IGS0002001).
Other high exposure groups include persons engaged in such outdoor occupations
such as forestry, research, fishing, lumbering, park and refuge maintenance,
outdoor sports and gardening. The only quantitative exposure data submitted
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-33-
relate to a research biologist in the Florida Everglades, who reported using 2
one-ounce bottles of 28.74% Deet per week on the skin, and 2 two-ounce cans of
71.25% Deet per week on clothing (Mazzotti, P. I960 MRID IGS0002004),,
Applications were made 4 days per week from May to October. Based on these
data, the Agency estimates that exposure is 4.25 g/day or 60.7 ng/kg/day,
assuming a body weight of 70 Kg. Application to clothing, also based on a 4-
day week, would be 20.2 g/day? an undetermined amount of the Deet applied to
clothing would to be transferred to the skin. These exposure estimates are
almost three times as great as the mmcimtm daily exposure to 90% of the general
population reported by S.C. Johnson Co. for a 30% active-ingredient product
(63.4 mg/kg/day vs. 22.7 mg/kg/day).
In conclusion, an average exposure to Deet active ingredient is probably in the
range of 10-20 mg/kg/day, with 90% of the population exposed to less than about
35 ng/kg/day. It has been estimated that about 1% of users apply 11.0 gm or
more per day to exposed skin areas. Thus, use of a 20% formulation would
result in an exposure of 31 mg/kg/day; for a 75% formulation, 117.6- mg/kg/day;
and for a 100% active product, 157 mg/kg/day. The above fiqures for exposure
are only estimates based on limited data for the numbers of grams of products
applied by users. Few data were available on the actual formulations used,
although pressurized liquid products containing 15-20% active ingredient are
claimed to be the most popular. The Agency acknowledges that the above
estimates are based on limited data taken from a small sample group; however,
they represent all the data currently available.
Occupational exposures could not be fully evaluated, although available data
indicate that military personnel may experience an annual exposure of up to
10.7 mg/kg/day and a research biologist in the Florida Everglades is exposed to
63.4 mg/kg/day. Although these exposure levels to military personnel appear to
be about the same as those of the general population, they occur with greater
frequency throughout the year; thus, the total annual exposures are likely to
be much greater.
Before a complete exposure profile is prepared, additional human exposure data
will be required, under Data Gaps below.
4. Data Gaps
To support the registration of Deet products, it is necessary to submit the
following data, which are explained in detail in the •Proposed Guidelines for
Registering Pesticides in the United States" (43 FR 29696, July 10, 1978).
a. Technical Deet
Guidelines Section
Hydrolysis 163.62-7 (a)
Activated Sludge 163.62-8 (g)
b. Formulated Deet
Hydrolysis 163.62.7 (g)
Human Exposure Data Special Requirements
(FIFRA Sec 3(c) (2)(B))
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-34-
1. Statistical data giving the percentage of total ILS. population exposed ta
Deet products, broken down by sex, age-group' (a'diilftsV teenagers^.children, and.
pregnant womenX Data on pregnant women are requested as a result of questions
of possible emoryotoxicity (See Chapter V);
2. Statistical data giving the geographical breakdown of the use frequency and
amounts of Deet products (i.e., the Southeast, Gulf States and Pacific
Northwest);
3. Data estimating the expected "average* or "normal* maximum exposure, per day
to an individual using Deet products. The data must encompass 90 to 99% of the
total population exposed to such products. In addition, worst case and
occupational exposure situations must be identified, including situations that
could be reasonably expected to occur, such as application to large areas of
the skin, frequent applications per day, etc. These estimates should be given
for each of the population groups specified above;
4. Identification of the types of Deet products most connonly used and the
percent active ingredient contained in each product.
5. Required Labeling
There are no environmental fate labeling requirements for technical or
formulated Deet.
B. Topical Discussions
Corresponding to each of the Topical Discussions listed below is the nunber of
the section in the "Proposed. Guidelines for Registering Pesticides in the
United States" (43 FR 29699, July 10, 1978) which explains the minimum data
that the Agency requires to adequately assess the environmental fate of Deet.
Special data requirements_are also specified.
1. Technical Deet
Data Requirement Guidelines Section
Physico-chemical Transformation 163.62-7 (a)
(Hydrolysis)
Metabolism 163.62-6 (g)
(Activated Sludge)
a. Hydrolysis
Technical Deet could potentially enter natural water via industrial discharge,
and as a result of disposal and cleanup of containers and equipment.
Hydrolysis data are therefore required on technical Deet to support the regist-
ration of technical Deet. Ho data on the hydrolysis of Deet are available;
this constitutes a data gap.
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-35-
b. Activated Sludge Metabolism
Pot the assessnent of Deet's potential effect on the wastewater treatment
process through indirect discharge into treatment systems, an activated sludge
metabolism study is required. No data on activated sludge metabolism of
technical Deet are available; this constitutes a data gap*
2, Formulated Deet
Data Requirement Guidelines Section
Ebysico-Chefflical Transformation 163.62-7 (a)
(Hydrolysis)
Human Exposure Special requirement
FIIWV Sec. 3(c)(2)(B)
Hydrolysis
Data are required for the same reasons as those listed under part (a) of this
section. A data gap exists for formulated Deet.
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-36-
V. TOXICOLOGY
A. Disciplinary Review
1. Toxicology Profile
a. Technical Deet
Sufficient data were available to assess the acute toxicity of technical Deet.
The oral LD-0 in rats (male rats » 2.43 ml/kg; female rats - 1..78 ml/kg)
indicates a potentially low acute oral toxicity in humans. The dermal LD5Q
in rabbits (3.18 ml/kg or greater) indicates a potentially low dermal toxicity
in humans. Likewise, the inhalation LCgg in rats (5.95 mg/1) indicates a low
acute inhalation toxicity in hunans.
Some information was provided on the irritation and sensitization potential of
technical Deet. In an eye irritation study conducted on rabbits, Q.I ml of
technical Deet induced marked transitory irritation and opacity. This study
strongly suggests that technical Deet is potentially a severe eye irritant.
Dermal irritation and sensitization studies conducted on rabbits and guinea
pigs, respectively, demonstrated that technical Deet is not a potential skin
irritant on sensitizer. No adequate subchronic toxicity data were available.
In several inadequate subchronic (90-day) dermal studies, technical Deet was
administered to rabbits. Conflicting results and inappropriate reporting
preclude the use of these studies to assess the subchronic dermal toxicity
potential; additional testing is required. Bowever, an adequate subchronic
inhalation scudy conducted on rats showed no abnormal behavioral signs or
pathology at 7.5 ng/1; the lowest effect level was 15.0 mg/1, the effect being
abnormal sperm morphology. Additional special testing was conducted on sperm
count, spernhead, morphology and sperm viability in rats dermally administered
doses of 0, 100, 300, or 1000 mg/kg/day of Deet 5 days each week for 9 weeks.
There were no compound-related effects at any dose.
Inadequate chronic toxicity data were available to assess long-term effects of
technical Deet. Supplementary studies - conducted on mice and rabbits
demonstrated no oncogen!c potential; however, inappropriate testing protocol
precludes the use of these studies and additional data are required. In
addition, conflicting teratogenicity studies were performed. An adequate
dermal teratology test conducted using rabbits snowed no effect at the highest
dose of 5000 mg/kg/day. However, an oral teratology test conducted on rats
resulted in a possible embryotoxic effect at 80 mg/kg/day; this test is not
adequate to satisfy the data requirement due to inappropriate testing protocols
and is therefore considered supplementary. An additional dermal teratology
test is required in the same species to clarify questions raised by the first
study. No adequate data were available to assess the reproduction toxicity
potential of technical Deet. Mutagenicity testing is incomplete. The
available mutagenicity data demonstrate that technical Deet does not induce
reverse mutations in S. typhinuriuau No dominant lethal effects at the dose
»pq»«H (600 mg/iog in male mice) were indicated in a supplementary study (deemed
supplementary because the maximum tolerated dose was not used). However, the
1^/ Soe the purposes of this Standard, a supplementary study is one that does
not meet required testing standards but does provide seme relevant information.
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-37-
dcninant lethal study showed a reduction of implants in pregnant females,
suggesting that further reproduction testing is necessary. In addition,
further nutagenicity testing is required to satisfy data requirements.
The available metabolism data were incomplete, but animal data suggest that
Deet is absorbed (rabbit is 36%; male rat is 43%; female rat is 32%; humans is
8-10%), rapidly excreted (rats » 68% in 24 hrs) and not bioaccunulated.
However, no metabolite identification data are available and additional
metabolism testing is required.
b. Formulated Deet
(l)Ready-ToHJse (RTU)
Based on available data (see Topical Discussions for details), statements of
formula and the intended pattern of use for Deet, the acute toxicity (oral,
dermal, inhalation), irritation (eye and dermal) and dermal sensitization
potentials are as indicated in Table 5. .
Table 5
Sunnary of Acute Toxicity Data on Ready-To-Use formulations
-l-Toxicity
(Testing
i
(Acute Oral
1
(Acute Dermal
1
(Acute Inhalation
1
1
(Primary Eye
1
(Primary Dermal
1
(Primary Sensit-
1 ization
1
Existing I
15-25%
Low
Low1/
Very low l/
Low
Very Low
Data gap
7IU Products
40-55%
Low I/
Low1/
Very Low ^
Data Gap 2/
27
Data Gap
27
Data Gap ^
—
75%
Low I/
Low1/
Very Low X/
Data Gap */
Data Gap /
Data Gap */
100%
Low
Low
Very Low
Severe eye
irritation
Very low
Mo Sensit-
ization
- —
Based on data extrapolation
Testing is required
(2)Pressurized Liquid (PrL)
Based on the available data (See Topical Discussions for details), statements
of formula, and the intended pattern of Use for Deet, the acute toxicity (oral,
dermal, inhalation), irritation (eye and dermal) and dermal sensitization
potentials are indicated in the Table 6.
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•38-
TableS
Stannary of Anita Tbxicity Data on Pressurized Liquid Formulations
IToxicity E
(Testing
I I
(Acute Oral
1
(Acute Dental
1
1 Acute Inhala-
1 tion
1
(Primary Bye
1
ln_J_..^. m.j_
Ixistinq PrL Pi
12-30%
Low
Low
Very Low 2/
Low
'
roducts I/
75%
I/
LOW3'
Low2/
Very Low */
Data Gap 3/
« fc j» ^/
I I 2/1 3/
I Primary (Data Gap I Data Gap
1SensitizationI I
l/_ Those existing PrL products which do not contain freon propellants
2/ Based on data extrapolation
3/ Testing is required
(3) Incremated Material (IroM)
Based on available data (see Topical Discussions for details), statements of
formula, and*the intended pattern of use for Deet, the acute toxicity (oral,
dermal, inhalation), irritation (eye and dermal) and dermal sensitization
potentials are as indicated in Table 7.
Table 7
Sunnary of Acute Toxicity Data on Impregnated Material Formulations
IToxicity
(Testing
1
(Acute Oral (LDcQ)
1
(Acute Dermal (LD.Q)
1
(Acute Inhalation (LC-0)
1
(Primary Eye
(Primary Dermal
1
(Primary Dermal
1 Sensitization
1
Registered ImM
11-27%
Low "'
Low1/
Very Low l/
Data Gap */
2/
Data Gap "
2/
Data Gap
1 Products
33%
Low "
Low1/
Very Low
Data Gap 2/
2/
Data Gap ^
2/
Data Gap '
I/ Based on data extrapolation
2? Testing is required .
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2. Toxicology Hazard Assessment
a. Technical Oeet
The information available to assess potential hazard as a-result of chronic
exposure is incomplete and inconclusive (see Topical Discussions and the
Toxicology Profile for details). Therefore, the oncogenic, teratologic,
mutagenic and reproduction effects resulting from chronic exposure to
formulated Deet, based on testing of technical Deet, cannot.be adequately
evaluated. Several supplemental studies (dominant lethal mutagenicity,
teratology, and subchronic inhalation toxicity) indicate possible reproductive
toxicity. Although the data are only suggestive, it is imperative to conduct
the necessary studies to resolve the questions of adverse effects.
b. Formulated Deet
(1) Ready-To-ilse
Because of the intended pattern of use for RTU Deet products, the likely routes
of exposure are dermal and occasional accidental oral, eye, and inhalation.
The existing RTU products have a low acute oral and inhalation toxicity
potential; therefore, single accidental exposures are not.expected to pose a
hazard. Accidental eye exposure is potentially serious because coroeal opacity
has been noted in a technical product; therefore, extreme caution should be
used when applying RTU products which contain more than 30% Deet. The
information currently available to assess the primary dermal toxicity and
dermal sensitization of RTU formulations is incomplete. Likewise, the data for
chronic exposure is incomplete and therefore a chronic toxicity risk cannot be
determined at this time.
(2) Pressurized Liquid (PrL)
Due to the intended pattern of use for PrL Deet products, dermal, and
occasional accidental oral, eye, and inhalation exposure are the likely routes
of exposure. Hawever, the existing products have a low acute oral and
inhalation toxicity potential; therefore, accidental exposures are not expected
to pose a hazard. Accidental eye exposure is potentially serious as comeal
opacity has been noted in a technical Deet product; therefore, extreme caution
should be used when applying RTU products. The information currently available
to assess the primary dermal toxicity and dermal sensitization is incomplete.
Likewise, the data for chronic exposure to technical Deet is incomplete and
therefore a chronic toxicity risk cannot be determined at this time.
(3) Impregnated Material (ImM)
Due to the intended pattern of use for ImM Deet products, dermal and occasional
accidental oral, eye, and inhalation are the likely exposure routes.However,
the existing products have a low acute oral and inhalation toxicity potential;
therefore, these single accidental exposures are not expected to pose a
hazard. Accidental eye exposure is potentially serious because corneal opacity
has been noted in a technical Deet product. The information currently
available to assess the primary dermal toxicity and dermal sensitization is
incomplete. Likewise, the data for chronic exposure is incomplete; therefore,
a chronic toxicity risk cannot be determined at this time.
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3. Generic Toxicology Data Gaps __ __
Technical Deet Guidelines Section:
Subchronic 90-day dermal (rabbits) . ........... . .................... 163.82-3
2-yr Dermal exposure combined with oncogenicity (rat) .............. 163.83-2
Dermal Chcogenicity (mouse) ...... ~...~....~ .............. „. ......... 163.83-2
Dermal Teratogenicity (rat) ..... ........ ....... .......... . ......... 163.83-3
Dermal Reproduction (rat) ...... ..... ...... ................... » ..... 163.83-4
Mutagenicity ........... ............... ... ............ ........ ...... 163.84-2
163.34-3
163.84-4
Metabolism (identification of metabolites) .................. .......163.85-1
Formulated Deet
Ready-To-HJse (RTU) _ ___
Primary Eye Irritation (40-55% and 75%) (rabbit) ................... 163.81-4
Primary Dermal Irritation (40-55% and 75%) (rabbits) ............... 163.81-5
Dermal Sensitization (15-25%; 40-55%; 75%) (Guinea Pig) ............ 163.31-6
Pressurized Liquid (Prf.)
Primary Eye Irritation (75%) (rabbit) ........ L .......... ... ......... 163.81.4
Primary Dermal Irritation (75%) (rabbit) ..... 1 ..................... 163.81-5
Dermal Sensitization (12-30%; 75%) {Guinea Pig) .................... 163.81-6
Impregnated Material (ImM) ;
Primary Eye Irritation (11.27% and 33%) (rabbit) ................... 163.81.4
Primary Dermal Irritation (11.27% and 33%) (rabbit) ................ 163.81-5
Dermal Sensitization (11.27% and 33%) (Guinea Pig) ............... ..163.81-6
4. Required Labeling
All technical and formulated Deet products must bear appropriate acute toxicity
labeling and statements of practical treatment as specified in the Gudiance
Package vhich accompanies this Standard.
B. Tooical Discussions
1. Acute Oral ToxTcity (163.81-1)
The minimum data requirement for testing acute oral toxicity (I-Bgg) is one
test for the technical formulation and one test for each registered product,
preferably using the laboratory rat.
a. Technical
Adequate acute oral toxicity studies were conducted as indicated in Tables 3
and 9.
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Table 8
Acute Oral Tbxieity of Technical Deet
1. -. :
J
^
Animal
Rat (M)
Rat (F)
Rat (M)
Rat (M)
Rat (F)
Rat (N)
Rat (F)
;
ta-DEET
90-100%
90-100%
Unspecified
95%
95%
95%
(in corn oil)
95%
(in corn oil)
">50
2.43 ml/kg
1.78 ml/kg
2.68 ml/kg
3.293/kg
2.425/kg
3.166 A?
2.17G/kg
Tbxieity
Category
in
in
in
in
in
in
in
Reference
Ambrose, 1959
MRID 100001051
Ambrose, 1959
MRID 100001051
Carpenter, et al~,
1974 MRID 105000243
U.S. Army, 1979
MRID IGS0002030
U.S. Army, 1979
. MRID IGS0002030
U.S. Army, 1979
MRID IGS0002030
U.S. Army, 1979
MRID IGS0002030
--
• "-
. . . _
.. - '
. -"
The above information is sufficient to satisfy the data requirement for acute
oral toxicity for technical DEET. The data indicate that technical Deet should
be assigned to Tbxieity Category HI for acute oral toxicity, which corresponds
to a low potential acute oral hazard.
In additional testing using the ortho(o)-isomer and the para(p)-isomer, which
occur as impurities in Deet, the acute oral toxicity in rats was as
follows:
Table 9
Acute Oral Toxicity of o- and p- Isomers of Deet
1 1 1
1 II
1 Animal I %-Deet 1 LD--
1 1 1 3°
1 1 1
IRat (M/F) 195% o-Deet I 1.21 g/kg
1 1 1
IRat (M/F) | 95% p-Oeet I 2.3 g/kg
1 1 1
1 1 1
Toxicity
Category
III
HI
'
Reference
Ambrose & Yost, 1965
MRID 100001102
Ambrose & Yost, 1965
MRID 100001102
The data indicate that o-Deet and p-Deet should be assigned to Tbxieity
Category HI for acute oral toxicity, which corresponds to a potentially low
acute oral hazard.
-------
-42-
b. Formulated Deet
(1) ReadyHTo-Use (RTU)
The acute oral LO.. in the rat is 2.10 a/kg (Warf, 1976 MRID 100001101) for
an 18% RIU product. The data indicate that the 18% RTU product should be
assigned to Toxicity Category III for acute oral Toxicity.
Because oral toxicity studies place both technical deet and the 18% RTU product
in Toxicity Category III, and because the inert ingredients in RTU Deet
formulations are not expected to increase the acute oral toxicity potential,
all existing RTU concentrations are placed in Toxicity Category III. Toxicity
Category HI. corresponds to a low acute, oral toxicity potential.
(2) Pressurized Liquid (PrL)
Adequate acute oral toxicity studies were conducted as reported Table 10.
Table 10
Acute Oral Toxicity of PrL Deet
-1
1
1 Animal
1
1
IRat (M)
IRat (F)
1
1
1
IRat (M)
IRat (F)
1
1
%n-DEET
15%
15%
30%
30%
^0
5-10 ml/kg
2-10 ml/kg
2.61 ml/kg
2.3 gAg
Toxicity
Category
III
III
in
in
I
Reference
Viarf, 1975a, 1975b
Warf, 1975a, 1975b
MUD 100001085,
100001086
Howard, 1971
toward, 1971
MRID 100001080
The table shows that PrL products at 15% and 30% concentrations are in Toxicity
Category III. Because technical Deet and the 15% and 30% PrL formulations are
in Toxicity Category III, and because the inert ingredients in the PrL
formulations are not expected to increase the acute oral toxicity potential,
existing PrL products between 12% and 75% concentrations, except those that
contain freon propellants, are classified in Toxicity Category III. Toxicity
Category HI corresponds to a low acute oral toxicity potential.
NOTE: Freon is regarded as a major hazard to the environment and its use in
consumer products has been prohibited by the Agency. For all existing
products which contain freon propellants the registrant must submit
formulation statements with replacement propellants. The Agency will
evaluate the new submissions on a case by case basis.
(3) Impregnated Materials (InM)
No data were available for the assessment of the acute oral toxicity of InM
products. Because technical Deet is placed in Toxicity Category III) and
because the inert ingredients in InM products are not expected to increase the
-------
-43-
acute oral toxicity potential, all existing InM products between 11% and 33%
concentrations are placed in Toxicity Category III. Toxicity Category HI
corresponds to a low acute oral toxicity potential.
2. Acute Dermal Toxicity (163.81-2)
The minimum data requirement for testing acute dermal toxicity (LD 5Q) is one
test for the technical product and one test for each registered formulation,
preferably using the albino rabbit. -...--
a. Technical
Adequate, acute dermal toxicity studies were conducted as indicated in Table 11.
Table 11
1
1
- (Animal
1
1
- IRabbit
IRabbit
1
IRabbit
1
1
'
%m-QEET
90-100%
unspecified
95%
'
greater than
4 ml/kg
3.18 ml/kg
4.28 g/kg
Toxicity
Category
in
in
in
1
1
Reference 1
1
1
Ambrose, 1959 1
MRID #00001051 |
Carpenter, 1974 I
MRID 105000243 1
U.S. Army, 1979 1
MRID IGS0002026I
1
The data indicate that technical Deet should be assigned to Toxicity Category
III for acute toxicity, which indicates a low potential acute dermal hazard.
The above data are sufficient to satisfy the data requirement for acute dermal
toxicity for technical Deet.
b. Formulated Deet
(1) Ready-To-Use (RTU)
The acute dermal LD-Q in the rabbit (abraded and unabraded skin) is greater
than 4 g/kg for a 15% RTU product (Davidow, 1960 MRID 100001139). The data
indicate that the 15% product should be assigned Toxicity Category HI for
acute dermal toxicity.
Because acute dermal toxicity studies place both technical deet and the 15% RTU
product in Toxicity Category III, and because the inert ingredients in RTU Deet
formulations are not expected to increase the acute dermal toxicity potential,
all existing RTU products between 15% and 75% concentrations are placed in
Toxicity Category III. Toxicity- Category, III corresponds to a low acute dermal
toxicity potential.
(2) Pressurized Liquid (PrL)
No data ware available to assess the acute dermal toxicity of the existing PrL
product. Because technical Deet is placed in Toxicity Category HI, and
because the inert ingredients in PrL products are not expected to increase the
acute dermal toxicity potential, all existing PrL products between 12% and 75%
-------
concentrations', except those that Incorporate- frotf propellents-, are classified
in Tbxicity Category III. Tbxicity Category III corresponds to a low acute
dermal toxicity potential.
(3) Impregnated Materials (ImM)
No data were available to the assess the acute dermal toxicity of the existing
ImM products. Because technical Oeet is placed in Tbxicity Category III, and
because the inert ingredients in InN products are not expected to incease the
acute dermal toxicity potential, all existing InM products between 11% and 33%
are classified in Tbxicity Category III. Tbxicity Category III corresponds to
a low acute dermal toxicity potential.
3. Acute Inhalation Toxicity (163.81-3) _
The minimun data requirement for testing acute inhalation- toxicity (LCSO) is
one test on the technical chemical and on each manufacturing use and formulated
product, preferably using the laboratory rat.
An acute inhalation toxicity (I£en) test is required for each formulation
that causes a respirable vapor, or for which 20% or more of the aerodynamic
equivalent is composed of particles not larger than 10 microns.
a. Technical
A supplemental acute inhalation study was conducted on rats (Ambrose, 1959 MRID
10000105). The animals were exposed to an unspecified amount of technical Oeet
(85% A.I.) aerosol for 6 hours. Toxic signs observed were slight bloody
discharge around the- eyes- and nose immediately after exposure; all rats
appeared normal at 24 hours. All rats survived the exposure; histopathologic
examination was negative- This study does not meet the data requirement for
-acute inhalation because the dose was not reported and therefore is considered
supplementary.
An adequate acute inhalation study was conducted on male and female rats (U.S.
Army, 1979 MRID KS0002034). The animals were exposed to 0, 3.70, 4.26,
5.19, 5.48 or 5.95 mg/1 of technical Deet for 4 hours. The LC^g was
calculated to be 5.95 mg/1 which corresponds to Toxicity Category IV,
indicating a very low acute inhalation toxicity potential.
The above data are sufficient to satisfy the acute inhalation toxicity data
requirement for technical DEET.
b. Formulated
(1) ReadyTo-Use (RTU)
No data were available to assess the acute inhalation toxicity of registered
RTU products. Because technical Deet is placed in Tbxicity Category IV, and
because the inert ingredients in RTU products are not expected to increase the
acute inhalation toxicity potential, all existing RTU products between 15% and
75% concentrations are placed in Toxicity Category IV. Toxicity Category IV
corresonds to a very low acute inhalation toxicity potential.
-------
45-
(2) Pressurized Liquids (PrL)
The available data were invalid to assess the acute inhalation toxicity of the
15% PrL product. Because technical Deet is placed in Tbxicity Category IV, and
because the inert ingredients in PrL products are not expected to increase the
acute inhalation toxicity potential, all existing PrL products between 12% and
75% concentrations, except those that incorporate freon propellants, are placed
in Tbxicity Category IV. Tbxicity Category IV, corresponding to a very low
acute inhalation Tbxicity potential.
Material (InM)
tb data were available to assess the acute inhalation potential of existing InM
products. Because technical Deet is placed in Tbxicity Category IV, and
because the inert ingredients in InM products are not expected to increase the
acutie inhalation toxicity potential, all existing InM products between 11% and
33% concentrations are placed in Tbxicity Category IV. Tbxicity Category IV
corresponds to a very low acute inhalation toxicity potential.
4. Primary Eye Irritation (163.81-4)
The minimal data- requirement for primary eye irritation is one test for the
manufacturing-use product and one test for each registered product, preferably
using the albino rabbit.
a. Teehnical/Manufacturino-Use Product
A primary eye irritation study was conducted on rabbits (Ambrose, 1959 MRID
100001051) using one drop (0.04 mg) of Deet. The Deet produced moderate edema
and erythema and sane "cloudiness" in 3 rabbits for 72 hours; after 5 days all
eyes were normal. This study is not sufficient to meet data requirements for
eye irritation because the scoring system used was not identified and the
individual scores were not reported. It is therefore considered supple-
mentary. However, this study does suggest that technical Deet is a potentially
severe eye irritant in rabbits.
An adequate eye irritation study was conducted on rabbits (U.S. Army, 1979
MRID f GS0002025). A dose of 0.1 ml of technical Deet was instilled into the
lower conjunction of the rabbit eye and evaluated by the method of Draize
(1959). The following results were reported:
Table 12
Results of U.S. Army (1979) Eye Irritation Study
(Structure
1
1
1
1 Cornea
llris
iConjunctivae
Me
24 hrs.
0.5
0.2
2.7
san Draize
48 hrs.
0.2
0.0
1.0
Score
72 hrs.
0.0
0.0
0.4
7 days
0.0
0.0
0.0
This study indicates that technical Deet induced marked transitory eye
irritation and trans itc/^y corneal opacification. This information indicates
-------
-46-p
that technical Deet is- irritating to the rabbit eye due to the transitory
corneal opacity noted. Ibis information is sufficient to satisfy the data
requirement for primary eye irritation for technical Deet.
b. Formulated Deet
(1) ReadyHTo-Use (RTU)
Two adequate primary eye irritation studies- were conducted on existing- RIU
products as shown in Table 13.
Table 13
Primary Eye Irritation of RTU Deet
(Animal
1 1'
Rabbit l/
%m-QEET
15%
15%
Dose (Results
1
100 ng (Mild irritation at
148 hrs but absent at
172 hrs; no corneal
(opacity.
1
Oil (Mild irritation at
(48 hrs. but absent
lat 72 hrs; no corneal
(opacity
1
1 Reference!
1 1
IDavidow 1
I960, 1
MRID (
1000011391
I
Warf (
1976, I
ratio I
100001101 I
1
I/
Washed and Unwashed Byes
The above data are sufficient to classify registered 15% and 18% RTU products
as mild, transitory eye irritants. However, due to the reported results on
technical Deet, each of the existing RTU products between 20% and 75% oust be
tested for eye irritation potential.
(2) Pressurized Liquid (PrL)
Adequate primary eye irritation studies were condt
as shown in Table 14.
ted on existing PrL products
-------
-47- :.
Table 14
Primary Bye Irritation of PrL Deet
1 Animal
Rabbit1'
Rabbit1/
Rabbit1/
Rabbit1/
%D£ET
15%
15% —
30%
30%
1 Dose .
1
1 second
spray
.
0.1 ml
cond en-
sate
0.1 ml
conden-
sate
2 second
spray
Results
Mild irritation
at 72 hrs but
absent at 4
days, no cornea!
©pacification
Mild irritation
at 72 hrs, but
absent at 4
days; no corneal
opacity
Mild irritation
at 48 hrs; but
absent at 72
hrs; no corneal
opacity
No irritation
at 48 hrs;
no corneal
opacity
Reference
,,.
WARF 1975b
MRZD #00001085
•
WARF 1975b
MRID $00001085
Woodward
•
Durloo and
Woodward
1971b MRID
100001082
Durloo and
Wbodvard
1971b MRID
f 00001082
— . . -
— • "
~ '•
• - ;• '
;
:
'
.
I/
2/
Mashed and Unwashed Eyes
Unwashed Eyes
The above data are sufficient to classify the tested 15% and 30% PrL products
as mild, transitory eye irritants.
However, due to the reported results on technical Deet and the possible eye
irritating inert ingredients in some products, each of the existing products
must be tested for eye irritation potential.
(3) Impregnated Material (InM)
No data were available for the assessment of the eye irritation potential of
registered ImM products. However, due to the reported results on technical
Deet all ImM products must be tested for eye irritation potential.
5. Primary Dermal Irritation (163.81-5) .
The minimum data requirement for primary dermal irritation is one test for the
manufacturing-use product and one test for each registered product, preferably
using the albino rabbit.
-------
-48-
a. Technical/Manufacturing-Use: Product.
Adequate primary dermal irritation studies were conducted as indicated in IS.
Table 15
Primary Dermal Irritation of Technical Deet
Animal
Rabbit
Rabbit"
|.
%nHDEET | Irritation Signs
1
90-100% 148 hrs - slight edema
148 hrs - slight
1 erythema
I 7 days-clear
95% 124 hrs - slight
1 erythema
148 hrs - slight
(erythema
17 days - clear
1
Toxicity—
Category
IV
IV
- -Reference
Philipps 1972,
MUD *
05000242
" -U~.S. Army; •
1979
MRID 1
GS00020269
I/
Abraded and unabraded skin
These studies show that technical Deet is mildly irritating to rabbit skin and
corresponds to Toxicity Category IV, indicating a very low primary dermal
irritation potential. This information is sufficient to satisfy the data
requirement for primary skin irritation for technical Deet.
b. Formulated
(1) ReadyTo-Use (RTO)
Adequate primary dermal irritation studies using rabbits were conducted on the
registered RTU products shown in Table 16.
Table 16
Primary Dermal Irritation of RTU Deet
1% m-DEET
115%
13%
Results
No irritation at 72
hrs. using abraded
and nonabraded skin.
Mild irritation at
72 hrs. using
abraded and
nonabraded skin.
Toxicity Category
IV
IV
Reference I
1
Davidow I960 |
MOD * 000011391
1
1
WRF 1976 I
MUD f 000011011
1
1
1
As per the available data on the 15% and 18% RTU products (Toxicity Category
IV) and technical Deet (Toxicity Category IV), products between 15% and 25% nay
be classified as Toxicity Category IV, corresponding to a very low primary
-------
-49-
dennal irritation potential. However, dua to the intended use pattern of Deet
and the lade of available data, all products which contain greater than 25%
Deet must be tested for primary dermal irritation potential.
(2) Pressurized Liquids (PrL)
The-following adequate dermal irritation studies using rabbits were conducted
on registered PrL products: ,~ , j -
Table 17
Primary Dermal Irritation of PrL Products
I* m-DEcr
Results
I loxicity category
•;•. -
—
1
|13%-15.45%
30%
No irritation at 72
hrs. using abraded
and nonabraded skin.
.
No irritation at
72 hrs. using
abraded and
nonabraded skin.
IV
-
rv
1 JohnSoil, 1972;
iWUD'ft 00001073
WARP, 1975a;
MUD ft 00001085
WARF, 1975b
MUD ft 00001086
Durloo and
Woodward, 1971a
MRID ftOOOOlOSl
The data show that 15% and 30% PrL products are placed in Tbxicity Category
IV. Because technical Deet and the 15% and 30% PrL products are placed in
Tbxicity Category IVr and because the inert ingredients in PrL products are not
expeccted to increase the primary dermal irritantion potential, all existing
PrL products between 12% and 30% concentrations, that do not incorporate from
propellants, are placed in Tbxicity Category IV. Tbxicity Category IV
corresponds to a very low primary dermal irritation potential.
(3) Impregnated Material (InM)
No data were available for the assessment of the primary dermal irritation
potential of the registered InM products. Due to the intended use pattern of
Deet and the lack of available data, all InM products must be tested for
primary dermal irritation potential.
6. Dermal Sensitization (163.81-6)
The minimum data requirement for dermal sensitization is a test for the
technical product and each registered formulation preferably using the guinea
pig.
-------
-50-
». Technical/Manufacturinq-Use-
An adequate dermal sensitization study was conducted on guinea pigs (U.S. Army
1979 MRID GS0002026). The animals received 10 appliations of 0.1% technical
Oeet followed by an insult application after a 2 week rest. No sensitization
reaction was noted. These date indicate that technical Deet is not a skin
sensitizer.
b» Fomilated
(1) ReadyTo-Use (RTU)
A supplementary dermal sensitization study was conducted on guinea pigs
(Ambrose, 1959 MRID 10001051). The animals received 10 applications of 1 ml of
10% Deet in isopropanol on the dipilated flank. Fifteen days following the
last application, the animals received a single insult application. Slight
dermal irritation was seen after the 3rd or 4th application; no other reactions
were noted. This data suggests that 10% Deet in isopropanol is not a skin
sensitizer.
Due to the intended use pattern of Deet and the limited available data, all RTU
products must be tested for dermal sensitization.
(2) Pressurized Liquid (PrL)
No data were available for the assessment of the dermal sensitization potential
of any PrL product. Due to the intended use pattern of Deet, each of the
registered PrL products between 12% and 75% and all new products must be tested
for dermal sensitization potential.
(3) Impregnated Materials (ImM)
No data were available for the assessment of the dermal sensitization potential
of any impregnated materials product. Due to the use pattern of Deet, each of
the existing InM products and all new products must be tested for dermal
sensitization potential.
7. Subenronic Oral Toxicity
The minimum data requirement for testing subchronic oral toxicity is testing in
two manmalian species, preferably the dog and rat, using the technical product.
Subchronic oral testing is not required for Deet because a significant exposure
via the oral route is unlikely. However, the following data were available:
A supplementary 200 day feeding study was conducted on rats (Ambrose, 1959 MRID
W0001051). Groups of rats (10 male, 10 female) wera fed 0, 0.01, 0.05, 0.1,
0.5, or 1% m-Deet (equivalent to 4.5-10.0, 23.5-45.6, 48.0-92.2, 267.0-474.0,
and 531.0-1055.0 mg/kg/day, respectively) in the diet. Male and female rats in
the 1% group showed lower weight gains than controls. Average daily food
consumption, red cell and plasna cholinesterase values, and hemoglobin counts
did not differ from control values for any treatment group.
Control and treated animals had comparable blood cholinesterase values, gross
pathology and histopathology. However, there was a statistically significant
increase in the organ-to-body weight ratio in the tastes, kidneys and liver as
indicated in Table IS.
-------
-Si-
Table 18
Organ-to-flody Weight Ratios in Ambrose, 1959 Study
1%
1
1
Dee t| Body
1 o "
10.01
10.05
10.10
10.50
11.00
1
1
1 Male
1405
1408
1389
1386
1385
1366*
weight
• I Fema.
~T
1
1
1
\
\
232
242
237
229
224
209*
(ojn) (Organ to
body weight
ITestes** (Kidneys
le (Male (Male
10.71+0.03
10.7640.03
10.75+0.01
10.8140.02
(0.86+0.05*
(0.8740.02*
ratios
1
(Females
(Liver
1 Males
1
(Females
(0.55+0.01 (0.57+0.01 12.5+0.07 (2.7+0.13
10.57+0.02 (0.53+0.06 (2.7+0.10 (2.5+0.25
10.59+0.03 (0.57+0.02 (2.6+0.09 (2.6+0.23
10.57+0.02 (0.57+0.01 (2.6+0.10 (2.3+0.06
(0.99+0.03 (0.59+0.02 (3.0+0.11*13.0+0.03
(0.6240.02*10.6440.03*13.140.14*13.6(0.12*
1 . - .
1
•Significant at 5% level. ' ~ - '
**The increase in body-weight ratio in the testes suggest a dose-response
relationship.
Another supplementary subchronic oral study using technical Deet in dogs was
reviewed (Woodward, 1959 MRID f 00001029). Groups of two male and two female
beagles were given 85% m-Oeet with 10% other isomers) orally by capsule at 0,
0.1, or 0.3 ml/kg/day for 13 weeks. After each daily dose, dogs at the 0.3
ml/kg/day dose level shoved signs of slight-to-moderate central nervous system
excitation consisting of tremors and hyperactivity. Bnesis occurred "from time
to time." Animals treated at 0.1 ml/kg/day showed only slight hyperactivity.
Hemograms taken throughout the study failed to reveal any consistent changes.
At necropsy, there was no evidence of gross pathology associated with the
treatment. Organ weights were within normal limits for all animals.
Histological studies of all tissues examined (liver, kidney, heart, spleen,
ovary, uterus, testis, and adrenal) were within normal limits.
8. Subchronic 21-Day Dermal Toxicity (163.82-2)
The minimum data requirement for subchronic 21-day dermal toxicity is one test
for the technical chemical, preferably using the albino rabbit. However, a
subchronic 21-day dermal test is not required for Deet because the intended use
of Deet is purposeful application to the skin and the need for a 90-day dermal
toxicity test precludes the requirement for a 21-day dermal toxicity test.
9. Subchronic 90-Day Dermal Toxicitv (163.82-3)
The minimum data requirement for subchronic 90-day dermal toxicity is one test
for the technical chemical, preferably using the albino rabbit. The subchronic
90-day dermal toxicity is required because pesticidal use of Deet involves
purposeful application to the skin.
Two supplementary subchronic dermal toxicity tests were conducted on rabbits
(Ambrose, 1959 MRID 100001051 and Wbodard, 1959 MRID t 00001029). These were
as follows:
t
1. The application of Deet (85-100% m-Deet) to intact rabbit skin for 90 days
at a dose of 1 mlAg/day produced moderate skin irritation but no effect on
weight, behavior, or mortality (Ambrose, 1959 MRID 100001051). Although
these data suggest no systemic effects of technical Deet, the lack of
-------
-52-
pathologic examination and reporting of clinical parameters precludes the
use of this study.
2. In the other study, rabbits (six per dose) dennally dosed the 0, 0.75, 1.50
and 3.0 tnl/kg/day of Deet (85% m-Oeet, 10% Deet iscmers) for 90 days showed
mild dermal irritation (0.75 ml/kg/day) to severe dermal irritation (3.0
mlAg/day) (Wbodard, 1959 MRID * 00001029). In addition, increased kidney
weights and marked histopathological changes were noted in the intermediate
dose animals (1.5 ml/kg/day). Two rabbits dosed at 1.5 ml/kg/day died, and all
the rabbits at the high dose (3.0 ml/kg/day) dies. However, the lack of
clinical data (e.g. growth curves, blood chemistries, etc.) and the lack of
data on individual animal preclude the use of this study.
The available information is not sufficient to satisfy the requirement on
subchronic 90-day dermal toxicity; additional testing is required.
10. Subchronic Inhalation Toxicity (163.82-4)
The minimum data requirement for subchronic inhalation is one test for the
technical formulation, preferably using the laboratory rat. The registered end
uses of Deet could result in repeated inhalation exposure.
A supplementary subchronic inhalation study was conducted on rats (Ambrose,
1959 MRID fOOCOlOSl). Rats exposed to air "saturated" with Deet in an
inhalation chamber for 8 hours a day, 5 days a week, for 7 weeks showed no
effect on behavior, mortality, of histopathology. Although the data suggest
that no adverse effects resulted from subchronic inhalation exposure, this
study is not sufficient to meet data requirements for subchronic inhalation
because actual doses-were not reported, and incomplete pathology was reported.
M adequate subchronic inhalation study was conducted on rats (male and female)
and Beagle dogs (male and female) (U.S. Army, 1979 MRID 3GS 0002034). The
animals were exposed to aerosol concentrations of 0 (room air), 2.5, 7.5, or
15.0 mg/1 of Deet for 6 hours per day, 5 days per week for 13 weeks. The
lowest effect level (LEL) for rats is 15.0 mg/1 (transient red exudate around
the eyes and nose were noted); the no effect level is 7.5 mg/1. In addition,
an increase in sperm with abnormal morphology was noted in rats at the 15.0
mg/1 dose. However, this effect is evidence that mutagenicity and reproductive
testing are necessary.
11. Chronic Feeding/Dermal Toxicity (163.83-1)
The minimum data requirement for chronic feeding/dermal toxicity is one test
for the technical chemical, preferably using the laboratory rat. A chronic
dermal study is required because pesticidal use of Deet could result in
application to the skin for significant periods of time. The chronic dermal
toxicity study would be conducted as a part of a chronic feeding study.
12. Oncogenicity (163.83-2)
The minimum data requirement for oncogenicity is testing in two mammalian
species, perferably the rat and mouse, using the technical chemical.
A screening bioassay was conducted on rabbits and mice (Stenbaecfc, 1977 MRID?
05000045). Groups of 50 females mice or 5 rabbits (sex distribution
unspecified) received dermal applications of 10%, 50% or 100% Deet in ethanol.
-------
-S3-
The positive control used was EPBA. This study resulted in no statistically
significant results , and is also not adequate to satisfy testing requirements
for the following reasons: ..... -
The mouse experiment was conducted on only female mice with limited
histological examinations performed (only grossly observed lesions ware
examined microscopically and the extent of the examination was not descirbed);
no data were provided on individual animals; no clinical data were reported;
and there was; no indication if the ""y*""*" tolerated dose was administered.
The Rabbit study was conducted using an Insufficient number of animals;
no data were provided on individuals animals; no pathology report was provided
for tumor types; no clinical data were reported; there was no; no indication
if the maximum tolerated dose was administered; and there were early and
abrupt deaths (40% at the 10% and 100% dose levels at 80 weeks; 100% at 10%,
50% amd 100% dose levels at 90 weeks) , causing concern about the conduct of the
study. "--
Additional oncogenic testing is required in two mammalian species.
13. Teratology (163.83-3) ______ _ ___
.The minimum data requirement for teratology is testing in two mammalian species
using the technical chemical.
An adequate dermal teratology study (U.S. Army, 1980 MRID 4GS0002036) was
conducted on rabbits. Groups of 20 pregnant rabbits received daily dermal
applications of 0, 50, 100, 500, 1000, or 5000 mg DeetAg/day in ethanol
(vehicle control) on shaved backs from day 0 through day 29 of gestation.
Precautions were taken to prevent the animals from licking treated skin and
skin was not washed between treatments. There were no significant differences
between control and treated animals with respect to the fertility index, number
of implantations per animal, or number of fetuses per animal. In addition,
treatment did not change fetal weight, fetal length or placental weights and no
increases in the incidence of skeletal or soft tissue anomalies were observed
in treated groups when compared with untreated controls. This study
demonstrated that Deet has no teratogenic or embryotoxic effects in rabbits
exposed dermally to technical Deet.
An additional supplementary teratology study (Grahwitt, 1977 MRID } 00001063)
was conducted on rats. Groups of 20 pregnant rats were daily administered 10
ml of peanut oil containing 0, 8, 20 or 80 mg/kg/Deet by gavage from day 5
through day 15 of gestation. No significant differences were reported between
control and treated mothers with respect to fertility, fetuses per liter, fetal
weight or fetal survival. However, the study did show decreases in number of
implantation sites per dam and number of fetuses per animal. In addition, a
related increase was observed in the number of. resorptions per dam (see suomary
table below).
-------
-54-
Table 19
Suomary of Results
in
U.S Army (1980) Teratology Study
Parameter Control 8mg/kg 20mg/fcg80mg/kg
Implantations/dam
Fetuses/dam
% Live fetuses
Fetuses/litter
Resorption/dam
10.65
10.45
100
10.45
0.20
10.00
9.25
100
9.74
0.75
10.21
9.37
99.44
9,89
0.84
9.10
7.70
100
9.10
1.43
These suonary data are somewhat misleading because two animals in the high dose
group had low body weights and had 8 resorption sites each. A third animal,
which had 5 resorption sites, delivered viable fetuses and its body weight was
comparable to control animals. These 3 animals represent 75% of the total
number of resorptions for this group. In addition, the number of implantations
per animal in the high dose group was lower than that in control animal (9.10
and 10.65r respectively). These results are not compound related because Oeet
dosing began 3 days after implantation normally occurs in rats.
These data suggest the possibility of impaired maternal health prior to the
administration of Deet; therefore, the significance of the suggested
embryotoxicity at 80 mg/kg/day cannot be determined. However, the suggested
embryotoxic effect is evidence that additional teratology testing is required
in the same species.
Another teratogenicity study was reviewed and deemed insufficient to assess
potential teratogenicity (deiberman, 1975 MRID §05000007). There are
insufficient details reported to assess the protocol and no characterization of
the chemical administered was reported in the study.
14. Reproduction (163.83-4)
The minimum data requirement for measuring reproductive indices is one test in
the laboratory rat lasting two generations using the technical formulation.
An inadequate study was provided for assessment of the reproductive toxicity of
Deet (deiberman, S., 1976 MRID f 05000008). There are insufficient details
reported to assess the validity of the study and no characterization of the
chemical administered was reported.
Although this study is not suitable to meet data requirements for reproductive
testing it does suggest potential sperm abnormality. The authors report that
by "the special function-morphological examination of spermatozoa, both
motility time and the number of pathological forms (deformation, absence of
tail or head, thickening of middle piece, etc.) differed reliably from similar
indices in control animals." Without additional specific information the
Agency cannot interpret the significance or the validity of this finding.
Additional reproductive testing is required.
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-55-
15. Mutagenicitv (163.84-1 through-4)
Although the Agency's mutagenic testing requirements are not final, refer to
the •Proposed Guidelines' (43 FR Mo. 163, August 22, 1978) for information
ling the types of studies the Agency is considering. :
The following studies are representative and are likely to be required: ... .
1) Microbial point nutation -.-:-•: .
2) Mammalian in vitro point mutation
3) In vitro or in vivo cytogenetics or one of the following: heritable
translocatlon or dominant lethal
_ 4) Primary DNA damage, e.g. sister chromatid exchange or inscheduled ENA
synthesis. - - -_-
Mutagenic studies are required because pesticidal use of Oeet involves .
purposeful application to the skin. -..—: - -:. -.. •-
Several supplementary nutagenicity studies were reviewed for this Standard. In
one study (Litton Bionetics, Inc. 1977 MRIDIGS0002036), Deet did not induce
reverse mutations in S-9 activated or inactivated S. typhimurium TA-1535, 1537,
1538, 1598 and 15100, and did not induce gene conversions in inactivated S.
cerevisia 04. No conclusion could be drawn regarding the S-9 activation system
in S. cerevisia O4 in the sane study due to uncertainties in the preincubation
suspension technique.
A supplementary dominant lethal study was conducted using three groups of ten
male ICR/Ha Swiss mice (U.S. Army, 1979, GS0002021). The concurrent control
group was administered a single dose by gavage of 5 mg/kg corn oil, the
positive control group was administered 10 mg/kg TEH, and the experimental
group was administered 600 ing/kg Deet. The study resulted in no dominant
lethal effects, however, a statistically significant (p< 0.02) reduction of a
plants was noted in pregnant females. This effect is evidence that a
reproductive study is necessary. Although this study was generally conducted
adequately, the maximum tolerated dose was not administered; therefore, the
study is not sufficient to meet the data requirement for nutagenicity.
16. Metabolism in Laboratory Animals (163.85-1)
The minimum data requirement for metabolism is a single dose using the
analytically pure grade of the active ingredient in the radioactively labelled
form. A metabolism study is required using technical Deet because oncogenicity
and chronic studies are required.
Metabolism studies showing excretion levels and absorption rates are summarized
in Table 20. Tissue distribution studies are summarized in Table 21 and
several studies conducted during pregnancy are summarized in Table 22.
The studies on animals suggest that m-Deet is rapidly absorbed and excreted in
the urine. Distribution studies show the liver, kidney, bladder and lacrimal
glands are the preferred organs, however excretion rates are so high (98%) that
there is no evidence of bio accumulation. In addition, there is suggestive
evidence that m-Deet does cross the placenta in mice (Bloomquist, 1975 MRID
I 05000001} and rabbits (U.S. Army, 1979 GS0002023); however, there is no
accumulation of Deet in any fetal organ indicating rapid fetal excretion*
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-56-
Additional data is needed to identify metabolites of Deet an their potential
bioaccunulation.
Table 20
Metabolisn in Laboratory Animals
1 Animal
Guinea Pigs
Guinea Pigs
Mice
Mice
Rats
Rat/Male
Rat/Female
Rabbit
Dog
Ebse
594mg/kg
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-57-
Table 21
Tissue Distribution Studies
'. . 1
1
1
\ •
}.. - '
I
J
;
'
'
'
•t
Animal
1
Mice
Mice
Dose
15mg/kg
'
5u a/
10 gm
Route
Dermal
I.V.
Tissue Distribution/Time After Cosing
1) Lacrimal Gland, liver, Kidney nasal
mucosa/2 hrs.
2) Skin at application area, traces
in Bladder/6 days
3} Skin at application area/36 days.
1) Lacrimal gland, liver, kidney,
snail intestine (high level);
Adipose, central nervous system
(low level) /5 rain.
2) Lacrimal gland, renel marrow, nasal
mucosa, bladder, small intestine/1
hr.
3) Lacrimal gland, liver, nasal
mucosa, bladder, intestine (low
level) /24 hrs.
4) No trace of radioactivity at 4
days.
Reference
Bloomquist ,
(1977) MRID
505000002
Bloomquist,
(1975) MRID
fOSOOOOOl
'
.
. . ..
-
._ r i ..
.
. . -
~ —
— : :
-
_.
_:
. . •
Table 22
Tissue Distribution Studies
in Pregnant Animals
(Animal
1
iMice
Rabbit
Rabbit
Gestation Time
"Advances Dermal
Pregnancy"
Day-1 through
Day-29
Dsy-lS
Dose
SuCi/
10G
?
?
Route I Time/Result
I
I-V 1 (1) 20 minutes/fetal
Ibone marrow, urinary
1 bladder, gastric
I mucosa lens showed
1 "some accumulation";
(average low concen-
Itration in the fetus
(was "very low."
I (2) 4 hours/no accum-
lulation in any fetal
(organ.
i
i
Dermal iNo detectable radio-
(activity above beck-
1 ground was observed
Jin any fetus.
t
i
Dermal I Radioactivity was
("lower" in fetuses
(than comparable
(maternal specimens
1
Reference
Bloomquist
(1S77) MRID
$05000002
Bloomquist ,
(1975) MRID
505000001
U.S. Army
(1979) MRID
f GS0002034
U.S. Army
(1979) MRID
8GS0002034
-------
>-58-
17 i Clinical Trials —Metabolism and Phannacodynamics
Although comprehensive metabolic and pharmacodynamic studies of the absorption,
fate and excretion of Deet and its metabolites in human beings are not
available, a few studies have measured rates of evaporation, dermal absorption,
and urinary excretion.
Spencer et al. (1979, MOO 105007487) investigated the rate of evaporation of
Deet after dermal application. The average total loss from human skin by
evaporation, wiping, and stripping of the stratum corneum was 49% of the
applied dose. This also suggests that seme of the applied Deet that was not
recovered penetrated the skin.
Feldman and Maibach (1970, MUD f 05003588) investigated the dermal absorption
and excretion of radiolabeled Deet in four human volunteers. A total of 52 ug
of Deet was applied once to the ventral forearm. The total average urinary
excretion at 24 hours was 13.3% of the dose, at 48 hours it was 15.3%, and at
120 hours it was 16.7%.
Blomquist and Thorsell (1977, MRID f 05000002) applied 250 uCi of 14 C-Deet in
0.03 ml (0.12 mg/kg of body weight) of a 20% ethanol solution to the forearm of
one woman volunteer. The experiment was performed twice, but the time interval
between the two experiments was not specified. The amount of radioactivity
recovered in the urine during 48 hours was 5.5% of the first dose applied and
3.8% of the second. Washing of the treated skin area 8 hours after each
application resulted in the recovery of 8% of the first dose and 15% of the
second.
Markina and Yatsenko (1971, MUD t 05000599) investigated the dermal absorption
of different formulations of Deet (20-40% active ingredient) in 15 persons and
found that only trace amounts of Deet were detected in the urine when silcpne
or cellulose acetobutyrate additives were added to the Deet cream or lotion.
Mo toxicity was reported after 30 days of daily application of the lotion.
Medical examination revealed no effects.
These studies suggest that the dermal absorption of Deet is rapid but that
excretion rates are variable. The number of subjects in these studies,
however, is too small to allow more than a tentative conclusion regarding
excretion rates. Fhannacodynamic studies also suggest that a considerable
amount (15% or more) of the applied dose remains on the skin for at least 8
hours after application.
18. Dermal Irritation and Sensitization in Humans
Technical Deet (purity unspecified) in ethanol was not irritating to human skin
when applied as a single dose (Phillips et al., 1972 MRID * 05000242). When
applied to occluded human skin daily for 21 consecutive days as 1, 10, 20, 30,
60, or 80% ethanol solutions, mean scores over the 21-day period on a scale of
0-4 were 0.43, 0.13-1.13, 2.9, 2.4, 2.3, and 1.0, respectively. No irritation
was observed when 100% technical grade Deet or a 50% ethanol solution was
applied daily for 21 consecutive days to unoccluded human skin.
Ambrose (1959 MRID tOOOOlOSl) applied a 50% solution of Deet to the arms and
faces of five human volunteers once a day for 5 days. No irritation of the
-------
-59--. ,
arms was observed. However, after the third application some desquanation
around the nose was apparent in all subjects. No further symptoms were noted
after application of the solution was discontinued. _. ....
Lamberg and Mulrennan (1969 MRID I 05002308} applied patches moistened, with 75%
Deet-(as a liquid in 25% ethanol or as a spray in 25% dichlorodifluoromethane)_
to the anticubital fossae of 77 sen. This resulted in burns or in skin
reactions of either bullar or erosions resembling abrasions in 48% of the men...
-These reactions led to necrosis and scarring in some of the subjects. However,
when patches were applied to the upper inner part of the arm of 62 of these
men, there were no skin reations. .. _ .
Vos (1972 MRID 100001093) patch-tested 52 adults with 15% Deet liquid three
times a week for 9 weeks. After a 2-week rest period, a challenge patch was .
applied. Because only one of the subject developed a slight erythema after
removal of the challenge patch, it was concluded that Deet is not a skin. .
sensitizer. 7 ...
Blau and Kanof (1961 MRID #00001182) applied blotting paper impregnated with a
spray containing 7.5% Deet and 1.5% isobutyl salicyl cinnamate (Revlon Sun
Bath) to the backs of 402 women. After 48 hours, the patches were, removed and
.the skin was observed for signs of irritation. Of the 402 subjects, 9 showed a
"minimal plus-minus" reaction; the rest were negative.
These studies show that Deet is not usually a dermal irritant or a skin
sensitizer. However, in selected individuals and under special circumstances
Deet can cause extensive skin reactions.
19. Case Reports
Maibach and Johnson (1975 05000021) reported that a 35-year-old woman
developed red raised lesions after application of an insect repellent
containing an unspecified amount of Deet. She was given open patch tests for
sensitvity to several insecticides but only pure samples of Deet produced a
wheal and flare reaction, which is considered contact urticaria or immediate-
type hypersensitivity. Further investigation revealed that this response could
be passively transferred, indicating that the contact urticaria to Deet was
caused by an imnunologic response.
Gryboski et al. (1961 MRID 105000328) described the case of a 3.5-year-old girl
who, after exposure over a 2-week period to 180 ml of 15% Deet spray,
experienced a toxic encephalopathy including disorientation, staggering gait,
slurred speech, and episodes of crying out, stiffening into a sitting position,
extending the extremities, flexing the fingers, and dorsiflexing the toes. She
recovered after 4 days, and since that time she has reportedly been well. All
clinical examinations to discover other etiologic factors, including family
history, virology, bacteriology, and lead testing, proved to be negative;
however, tests to confirm that Deet was the causative agent in this episode
were not performed.
Zadjoff (1979 MRID 105007489) reported two additional cases of toxic
encephalopathy in children after exposure to Deet. A 5-year-old girl sprayed
nightly for 3 months with Mylol (containing 10% Deet) experienced a toxic
encephalopathy, including slurred speech ataxia, and generalized convulsions.
She died 24 days after hospitalization. The brain showed generalized edema
with congestion of the meninges, and the cerebral blood vessels showed swelling
-------
-60-
of endothelial cells. In another case, an 18-month-old girl ingested an
unknown amount of Mylel liquid containing 10% deet. The next day she became
irritable, displayed bizarre movements, and had depressed muscle stretch
reflexes. She improved somewhat during 6 weeks of hospitalization. After 6
weeks, her head control was not yet normal, and her tendon reflexes remained
depressed, but the case was not followed up.
Other reports of toxicity related to Deet exposure are discussed in Rabinovich
(1966 MRID 105000693) and the Pesticide Incident Monitoring System Report
Number 121 (PIMS 1978).
Rabinovich (1966 MRID 105000693) conducted a field trial on 600 lumbermen who
used a 60% Deet solution and reported occasional contact dermatitis,
aggravation of preexisting acne, conjunctivitis, and burning eyes.
Pesticide Incident Monitoring System Report Number 121 (PIMS 1978) lists 45
cases of Deet exposure found in the files of the Pesticide Incident Monitoring
System for the period covering 1966 to December 1978. For 29 of these cases,
data on the incident and sequelae were insufficient to draw any conclusions
relating to the toxicity of Deet. The remaining cases included 10 incidents of
temporary eye irritation; 6 cases of skin reactions involving blisters, rashes,
irritation, and hives; and 1 case of a generalized allergic response requiring
hospitalization.
The cited literature indicates that the general toxicity of Deet is low; that
local skin reactions are infrequent, but can be severe depending on the area of
application and on individual response; and the eye irritation, although slight
and temporary, occurs frequently. There is inadequate information to judge
potential effects in persons with preexisting allergic conditions or to
determine if other populations, for example, children and pregnant women are at
risk. ;
20.i Emergency Treatment
No information has been submitted on emergency treatment of Deet intoxication.
. 21. Special Testing—Sperm Count, Spermhead Morphology, Sperm Viability
A valid morphology, viability and sperm count was conducted in rats (Litton
Bionetics 1980 MRID IGS0002036). Groups of 80 male sprague-Qawley rats were
dermally administered doses 0, 100, 300 or 1000 mg/kg/day of Deet for 5 days
each week for 9 weeks.
There were no significant differences between treated and control rats with
respect to mean body weights and food consumption (no statistical tests were
considered necessary by the authors). Histological examination of the testes
of rats in the high dose and control groups revealed no lesions nor the
occurence of compund related hyposnermatogenesis. The appearance of liver and
kidneys in treated rats was normal at necropsy. The only organ weights
affected were those of liver and kidneys in the high dose rats at the first
kill (no effect on testes weight was as shown in Table 23.
-------
-61-
Table 23
Organ Weight Results in Litton (1980) Sperm Study
IDose 1
(mgAg) 1
1
0 1
1
1000 I
1
Mean liver
wt. (g)
19.2550
19.8400
1 % Body
1 wt.
1
1 4.4521
1
I 4.7427
1
Mean Kidney
wt. (g)
3.5100
4.2050
% body
wt.
0.8154
1.0062*
-
r
* significantly different from controls . • • _.
(P is less than 0.05) using the ..._.-_.
students +-test; no data fran low . -. _ •. — .
and misdosed groups reported. - -
There were no compund-related effects on sperm count, sperm head morphology, •
orsperm viability of treated male rats at repeated dermal doses up to 1000
mg/kg/day.
22. Age-Related Dermal Absorption Studies _ __;
The Agency is concerned with the possible age related differences in dermal
absorption of Deet because Oeet is used on children. Therefore, a dermal
absorption study is required in weanling and young adult rats. Rats are chosen
as the experimental animal because most of the toxicology and metabolism data
will have been performed in rats, thus permitting correlation of data.
-------
-62-
, Table 24
Tbxicity Category Indicators
Toxicity Categories
Hazard Indicators
Oral UD5Q
Inhalation LDeQ
Dermal ID--
; Skin Effects
'
I
Up to and
including
50 mg/kg
Up to and
including
0.2 mg/liter
Up to and
including
200 mgAg
Corrosive
II
From
50-500
mg/kg
From
0.2-2
mg/liter
From
200-2000
mg/kg
Severe
irritation
at 72 hours
III
From
500-5000
mg/kg
From
2-20
mg/liter
From
2,000-20,000
mg/kg
Moderate
irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 mg/liter
Greater than
20,000 mgAg
Mild or slight
irritation at
72 hours or
no effects
Table 24 A
Eye.Irritation Toxicity
Indicators for Formulated Deet Products
Acceptable for
Domestic Use
Not Acceptable
for Domestic Use
No corneal
opacity;
irritation
reversible
within 7 days
Corrosive; any corneal
opacity; irritation
persisting for 7 days
-------
-63-
VI. ECOLOGICAL EFFECTS
A. Disciplinary Review
1. Ecological Effects Profile and Hazard Assessment
Subpart E, "Hazard Evaluation: Wildlife and Aquatic Organisms," of the"
Proposed Guidelines, Registration of Pesticides in the united States",
published in the Federal Register on July 10, 1978, describes the fish and
wildlife data required by the Agency to assess the hazards of pesticides to
nontarget organisms and to provide for adequate precautionary labeling (43 FR
132, Part 163.70 through .72).
Formulated Deet is neither intended for application to outdoor sites, nor -
registered for such use; consequently, formulated Deet will not be reviewed in"
this Chapter. However, an understanding of technical Deet's toxicity to fish,
aquatic invertebrates and waterfowl is fundamental to the development of
appropriate clean-up measures in the event of a chemical spill into lakes, and
streams. The Agency's concern in this regard is supported by data indicating
that a high volune of technical Deet is manufactured in the U.S.; manufacturers
are located'in diverse areas of the country; and there are a large number of
formulators (over 100). The ecological effects review in this Chapter relates
only to fish, aquatic invertebrates and waterfowl, and not to upland game birds
or other non-aquatic wildlife, because the latter are not expected to
experience effects of aquatic spills.
In general, the available data were insufficient to support an assessment of
technical Deet's ecological effects. The only valid study, (McCann, 1972,
ratio I 00001026) provided data which demonstrate that technical Deet has a
slight acute toxicity to coldwater fish.
2. Data Gaps
The following gaps in the Ecological Effects data base must be filled to
adequately support the continued registration of technical Deet. After each
requirement is listed the section in the Proposed Guidelines of July 10, 1978
(43 FR 132, Part 163.70-.72) which describes the test in detail. These data
requirements are also listed in Table 1, Chapter 2.
1. Avian single-dose LD-0 (wild waterfowl, preferably mallard duck) 163.71-1
2. Fish 96-hour LCeQ for warmwater species 163.72-2
3. Aquatic invertefirate acute LC^Q 163.72-2
3. Required Labeling
There are no ecological effects labeling requirements for technical or
formulated Deet.
B. Topical Discussions
The data requirements listed below correspond to the sections in the "Proposed
Guidelines for Registration of Pesticides in the United States", published in
the Federal Register of July 10, 1978, which explain the data the Agency
requires to adequately assess the hazards of technical Deet to fish and
wildlife.
-------
-64-
Data Requirements Guidelines Section
Birds (wild waterfowl only) 163.71-1
Fish (cold and warrawater species) 163.72-1
Aquatic Invertebrates 163.72-2
Birds (wild waterfowl)
Mo valid studies on the effects of single oral doses of Deet to wild waterfowl
were submitted.
Because data were not available, no conclusion can be drawn about the toxicity
of Deet to wild waterfowl; this constitutes a data gap.
Fish
One valid study concerning the acute toxicity of technical Deet (95% a.i.) to
fish (McCann, 1972, MRID 100001026) provided data on coldwater species. McCann
reported a 24-hour LC-50 of 125 ppm and a 96-hour LC-50 of 172 ppn for rainbow
trout. These results are sufficient to characterize Deet as slightly toxic to
coldwater fish.
Ho data concerning the acute> toxicity of technical Deet to warrawater fish were
submitted; this constitutes a data gap.
Aquatic Invertebrates
No studies concerning the acute toxicity of Deet to aquatic invertebrates were
submitted; this constitutes- a^data gap.
-------
-65-
VII. EEFIOCY
A. Introduction
This chapter deals with the efficacy of Deet when utilized as the single, active
ingredient in an insect repellent product. The review of Deet data and the -
identification of data gaps is limited to efficacy data only as it relates to
public.health applications. The Agency has provided for the. waiver of efficacy
data-submission as a part of the registration process in-all other instances
(44 BR 2793; May llf 1979). "
The pest species found on registered Deet labels that fall within the Agency's
area of public health concern are as follows: . . - -
- ..Biting flies (black fly, sand fly, horse fly and Ceratopogonid species) .
diggers :
Deerflies - - - ~-
Fleas
Leeches
Mosquitoes
Stableflies
Ticks
The Agency reviewed all pertinent studies. Many papers, while providing valid
and useful data, were not considered because the data related, to formulations
containing more than one active ingredient. The Agency did not reject any data
on the basis of test methodology, but considered that all data would contribute
to the assessment of efficacy (See Appendix I.).
B. Efficacy Assessment
1. Factors Influencing Efficacy
Several factors appear to influence the efficacy of Deet. Major factors are
environmental conditions, extent of absorption and elimination, type of
repellent formulation, and avidity of the test species. Che or more of these
conditions always influences the duration of Deet's protection.
Environmental conditions, such as temperature and wind velocity, alter Deet
activity. Deet efficacy is reduced by increased perspiration rate, although
not by elevated temperature.
Although data generated by Smith (Smith et al., 1963, MRIDf 05000300) were
inconsistent, they suggest that perspiring might reduce Deet protection time
against the mosquito, Aedes aeqypti. Wind velocity also influences Deet
protection time. Khan (Khan et al. 1973 MRZD 05000193) demonstrated that wind
velocities of 192 meters per minute decreased efficacy on the order of 66% when
compared to data collected in a room with 'normal* air exchange rates.
The duration of repellent activity is influenced by washoff, abrasion from the
treated surface, and absorption. Water, from either rainfall or perspiration,
decreases the efficacy of Deet. Gouch (Gouch et al, 1971, MRIDf 05000214)
reported that netting treated with 0.25 gram active ingredient of Deet per gram
of netting was effective in repelling 90% of a population of Aedes
taeniorhychus mosquitoes for a period of 54 days. Approximately 0.3 inches of
precipitation, however, reduced the effectiveness to less than 90% when
-------
-66-
measured over the sane period. Similarly, Schiefer (Schiefer et al,-» 1976,
MRID OS000223) noted a reduction in the overall efficacy in response to
rainfall. Deet's effectiveness has been reported to be reduced by loss through
cutaneous absorption (Maibach et al. 1974, MRID 0500116). Since Deet is highly
lipophilic, it is reasonable to assume that loss by absorption would be
accelerated when lotions, creams, and stick-type formulations are applied.
Much data has been reviewed about the formulation dependency of Deet activity;
the Agency has considered only the effect of the range of percent active
ingredient in its target pest assessment.
Given the absence of data relating to the upper limit of Deet efficacy based on
percent active ingredient, the Agency will not prescibe the maximum level of
Deet allowable in any formulation. However, the Agency will consider
toxicology hazards of all formulations, balancing the risks against the
benefits of any formulation for which a suspected hazard exists.
Although overall efficacy of Deet can also be seriously reduced by inadvertent
abrasion from the skin, there are data that suggest the Deet can protect
surrounding untreated skin up to 4-8 cm. from the treated area (Kahn and
Maibach 1972, MRID 00001163).
2. Use Sites
a. Hunan Skin
The data clearly indicate that Deet products which contain greater than 10%
active ingredient are efficacious for use on human skin. Any performance
claims made must fall within the general parameters prescribed in each of the
pest-specific discussions in Fart 3 of this section. :
b. Clothing | :
To repel fleas and chiggers, the product must be applied to clothing in order
to work statisfactorily. In the case of other pests, (e.g. black flies,
mosquitoes, etc.), clothing treatment may be advisable. The Agency, therefore,
recognizes clothing treatment efficacy. The Agency also recognizes the
potential utility of specialty formulations for this use. The Agency will
consider the specialty products supported under this standard. Any performance
claims made must fall within the general parameters prescribed in each of the
pest-specific discussions under Target Pests below.
c. Tents and Bedrolls
A limited number of Deet products bear claims for treatment of tents and
bedrolls. The Agency has very little data directly related to this use (e.g.,
netting and general cloth treatment). However, through extrapolation from
these data, the Agency considers applications for use on tents and bedrolls to
be supported under this standard. Claims made for such applications must fall
within the general parameters prescribed in each of the following pest-specific
discussions.
d. Treatment of Screens in Domestic Dwellings
As in the proceeding case, a limited number of Deet formulations bear claims
for the treatment of screens. Again, while no data directly related to
screens are available, the Agency will extrapolate from the data available for
-------
-67-
nettihg treatment. Screen treatments nay not be claimed for all pests,
however. Claims for screen application nay only be made for mosquitoes,
ceratopognoid species and black flies. Any claims made for these pests must
fall within the parameters prescribed in each of the following pest-specific
discussions.
e. Outdoor Mist Application
A single registered Deet product is claimed to be efficacious for outdoor mist
application on and around lawn chairs, picnic tables, boats and other areas
where repellency might be desired. The Agency has been unable to relate these
sites or this method of application to available data. Since available data
show that Deet is effective only as much as 4 to 8 centimeters out from a
treated surface, (Kahn and Maibach 1972, MRID 00001163), the Agency contends
that such applications are ineffective. These claims will not be supported
under this standard. Registrants desiring to make these claims will be
required to submit supporting efficacy data.
3. Target Pests i
a. Black flies '
Deet, applied in formulations where it is the sole active ingredient, has been
demonstrated effective in repelling several Simulidae species for periods of
2.6 to 10 hours. Formulations for which acceptable"^ ta have been reviewed
range from 15 to 65% active ingredient. Although the available data are
inconclusive in establishing the low dose range at which Deet might prove
effective, they do indicate a distinct dose related reponse. A 15% Deet
formulation, applied at 1 gran per 645 cm was reported to effectively repel
S. venustum for a period of 2.6 hours (S.C. Johnson and Son, Inc. 1974, MRID
00001095). Ebemulations of 50 and 60% were effective in extending the
protection time to 10 and 10.6 hours respectively (Garnett and Lomax 1973, MRID
00001137).
b. Ceratopogonidae (Biting midges, sandflies)
Ebemulations containing a minimum of 15% Deet active ingredient, have been
shown to be effective against the Ceratopogonidae. The dose-effect
relationship is more obscure for this target pest, probably as a result of the
somewhat smaller data base. Deet formulations ranging from 15 to 50% have been
shown to protect against Ceratopogonidae species for periods of 3.0 to 7.0
hours.
c. Horse flies
There is an absence of data relating to the efficacy of Deet on horse fly
species. Claims for horse flies, therefore, are not supported by this
Standard. Any registrant desiring to add claims for horse flies must submit
.appropriate efficacy data.
d. Chiqqers
All available data on Deet efficacy against chiggers were derived from
laboratory studies involving cloth treatment. Although all the studies were
laboratory tests, the results were so consistent that the Agency considers the
data base adequate. Deet activity against chiggers primarily results
-------
-68-
from contact toxicity rather than repellency. Studies Indicate that Deet,
applied to cloth test surfaces, often exhibits toxic action in less than 60
seconds after application (USA 1959, MRID 00001165); (Gertler 1962, MRID
00001018). In tests conducted against Trombicula splendons, one of the two
most frequently encountered chiggers species within the United States, cloth
treated at 1 gram per square foot remained effective for a period of 15 days
(Kochhar 1974, MRID 05000150); (Gilbert 1957, MRID 05000237). .,Trombicula
alfreddugesi. was also killed at an application rate of 2 gm/ft (Gerberg
1966, MRID 0001171).
The data base for technical Deet is adequate, even when restricted only to
proof of Deet's toxicity to chigger species. It is also clear that Deet-
impregnated cloth can remain effective over a period of several days.
e. Deerflies
The data reviewed have indicated that the deerfly is the least susceptible of
all dipteran species to Deet products. Ebemulations ranging from 12.5 to 75%
have been evaluated. The duration of acceptable repellency has ranged from 1
to 8 hours, with an average of 1 to 2 hours. There are distinct differences
occuring between deerfly species. Schredc (Schreck et al. 1976 MRID 05002304)
noted differences in Deet protection time when tested against Qiryspos
atlanticus and C.. flavidus. C^ flavidus appeared more responsive to Deet; a
12.5% formulation afforded 135 minutes of protection. C-_ atlanticus however,
was repelled for only 13 to 32 minutes by a formulation containing 50% active
Deet. Similar results were obtained in an additional study utilizing C..
atlanticus as the test subject -(S.C. Johnson and Son, Inc. 1974 MRID
00001095). In this study, Deet provided adequate repellent activity for 36 and
27 minutes for skin-applied formulations containing 10 and 15% Deet
respectively. Available data establish that the Deet repels deerflies. The
data also indicate that protection time-varies considerably due to sensitivity
of different species. i
f. Fleas i
Few studies are available on the efficacy of Deet products on fleas. Those
studies which have been located and reviewed deal primarily with Xenopsylla and
Ceratophyllus species. In laboratory studies (Kasafutdiner 1971, MRID
05000077), Deet applied to cloth at 40 grans of active ingredient per square
meter provided 100% repellency against Ceratophyllus tesguorum for a period of
30 days. In field tests with humans (Fristane et al. 1970 MRID 05000589), a
40% Deet formulation applied to footwear and overalls at a rate of 80 grams of
active ingredient per square meter afforded protection for 1-2 months against
Xenopsylla gerbilli fleas. Dremova (Dremova et al. 1977, MRID 05000086)
conducted laboratory trials and found that Deet treated cloth (20 grams active
ingredient per square meter) provided over 90% repellency of Xenopsylls cheopis
for a period of 15 days. In another laboratory study, Zolotarev and
Stavroskaya (Zolotarev and Stavroskaya 1960, MRID 05004738) found the p-isomer
of Deet to be the most effective in repelling a mixed population of fleas. The
m-isomer, while somewhat less effective that the p-isomer, was effective for
periods of 2 to 35 days; the variation in the protection period being largely a
function of application rate. Despite the relatively small data base, the
available data are adequate in establishing Deet repellency toward fleas for
products containing 10% or more active ingredient of Deet. There is only a
slight variation between the different species' response to Deet. There are no
data on formulations containing 10% active ingredient or less. The Zolotarev
-------
-69-
paper clearly establishes a dose/response relationship.
9. Leeches
Field and laboratory data indicate that Deet provides short-term protection
against Haenadipsa and Hirudo leeches. Saxena et al. (Saxena, et al. 1969,
MRID 05003639) conducted field tests to determine the efficacy of" Deet against
the terrestrial leech Haemadipsa sylvestris> Deet was reported effective
against the test species for at least 2 days after treatment when applied to —
boots (6 milliliters) and anklets (4 millilters). Four milliters of Deet
applied to the forearms, lower portion of the legs, neck and face of test
subjects provided protection against the leech for at least 8 hours after
treatment.
In tests conducted with aquatic leeches, Hirudo spp., Deet efficacy was-
marginal. Laboratory trials conducted with a 33% active ingredient preparation.
produced 30 minutes repellency. Field trials with the same formulation,
however, provided only 12 minutes of protection. Additional field trials
conducted with 45-50% Deet in varying inert formulations yielded protection
times ranging from 1 to 50 minutes (Keegan et al. 1964, MRID 05002310). In a
separate study, Keegan and Weaver (Keegan an? Weaver 1964, MRID 00001035)
.evaluated 75% lotions and pressurized sprays containing 12.75% of Deet active
ingredient. A 50% reduction in the number of leeches on a test subject was
observed after five minute exposure periods. Neither formulation remained
effective for a second five minute period.
The data indicate that formulations containing at least 50% Deet active
ingredient adequately repels terrestrial leeches. With respect to aquatic
leeches, the data are inadequate to support label claims.
h. Mosquitoes
(1) Laboratory Studies
Most of the laboratory studies reviewed evaluated the efficacy of Deet against
Aedes aegypti using the "first confirmed bite" method. Formulations ranging
from 6.25 to 100% active ingredient of Deet afforded protection for periods
from 2 to 14 hours. The wide variation in response resulted from a variety of
factors. These factors may have included subject susceptibility, individual
differences in laboratory-reared populations, time of day of the test, and
other undescribed environmental conditions. The data further indicate that
Deet can provide at least 3 hours of protection against mosquitoes following
direct skin applications of formulations containing 10% or greater of the
single active ingredient. Laboratory tests conducted to determine the minimum
effective dose indicate that at least 0.02 to 0.20 milligram of Deet per square
centimeter of skin must be applied to protect the forearms of human subjects
exposed to caged A^ aegypti.
(2) Field Studies
Numerous studies have been conducted to evaluate the effectiveness of Deet
against mosquitoes. The data demonstrate that Deet is effective in repelling a
wide spectrum of mosquito species, i.e., Aedes, Culex, Mansonia, Anopheles, and
Psorophora. The protection times afforded by various dose levels ranged from 1
to 24 hours. Following exposure to 100% active ingredient Deet, maximum.
protection times of 20 hours were obtained against Culex pipiens and mixea
-------
-70-
populations comprised primarily of Aedes and Mansonia species. Formulations
ranging from 10 to 50% afforded adequate protection from both Aedes and Culex
mosquitoes.
Both the field and laboratory data currently available clearly indicate that
Oeet is effective in repelling mosquitoes.
i. Stableflies
A relatively large nunber of papers dealing with Oeet efficacy against the
stablefly (Stomoxys calcitrans) are available. They provided a clear
indication that Deet is effective in protecting hunan subjects from stablefly
biting. A distinct dose/response relationship exists. The minimun protection
time afforded a hunan test subject was 2.7 hours (S.C. Johnson and Son, Inc.
1924, MRID 00001095). This protection time resulted from a 1 gram per 645
cm application of a 10% single active Oeet formulation, the lowest percent
active ingredient formulation for which data appear available. The maximum
protection time indicated by the data was 8 hours, afforded by a 25% Oeet
active ingredient and ethanol formulation (Gilbert et al. 1957, MRID
05000236). Although formulation strengths up to 50% have been tested, the 8
hour duration reported by Gilbert was the maximum recorded for all studies. It
can not be inferred, however, that 25% is the optimum Deet concentration for
protection against Stableflies, since other factors (wind, precipitation, etc.)
also affect the product's effectiveness.
The data currently available clearly indicate that Deet is effective in
repelling Stableflies. ;
j. Ticks
Wide variations in response levels have been noted in data on Deet applied to
tides. The variation appears relative to species, sex; and life stage
(Simironva and Dremcva 1971, MRID 05002661) (Novak 1973, MRID 05000290). Even
in studies conducted on the same subjects, considerable variation in test
results are reported. In studies involving the Lone Star Tick, Amblyomma
americanum, Gilbert (Gilbert 1957, MRID 0500237) reported marginal repellency
when Deet was applied to cloth test surfaces at the rate of 2 grams active
ingredient per square foot. Eight hour repellency was recorded at 52% active
ingredient. In a field study; however, Gerberg (Gerberg 1966, MRID 00001171)
reported adequate repellency for 7 hours utilizing the same 2 gram active
ingredient per square foot application rate. Similarly, studies conducted on
the Brown Dog Tick, Rhiphicephalus sanquineus, provided divergent results. In
laboratory trials, Deet-treated cardboard (70% m-isomer at 5 milliters per
square inches) yielded virtually no repellent activity (Kochhar 1974, MRID
05000150). A 25% Deet cream formulation, however, provided 21 to 42 hours of
protection when applied at a rate of 0.018 - 0.028 milligrams per on to the
shaved back of rabbits.
Although the Agency has reviewed papers dealing with a wide range of tick
species, most available data are from foreign sources and involve species not
found in the United States.
Among the species of concern to the Agency, Demacantor anderstoni, D^
variabilis, Ixodes scapularia, and 1^ pacificus do not appear within the
literature. Given the absence of data relating to the majority of the tick
species and the inconclusive nature of the overall data base, claims for tick
-------
-71-
repellency are not adequately substantiated. Claims for ticks, therefore, are
not supported by this Standard. Any registrant desiring to retain or add
claims for ticks must submit the appropriate efficacy data.
C. Data Gaps _.„
1. Use Sites
Registrants desiring to make claims of Deet efficacy for outdoor mist -
application will be required to submit supporting data.
2. Target Pests __.
a. Ceratopogonidae
The Agency will require formulation-specific data in each instance where a
specific duration claim is requested.
b. Fleas . __
The Agency will require formulation-specific data in each instance where a
specific duration claim is requested.
c. diggers
Virtually no data are available related to formulated products. Rather than
require formulation-specific data for repellancy, at the time of product
reregistration, registrants claiming on the label, "kills chiggers", must
submit the calculations that demonstrate that the product will satisfactorily
deposit a minimum of 1 gram of Deet active ingredient per square foot of
treated cloth, when used in accordance with label directors. Since the Agency
will not prescribe acceptable duration claims, whenever a claim of product
duration is requested, formulation specific data must be developed and
submitted for Agency evaluation.
d. Leeches
Registrants desiring claims for aquatic leeches will be required to submit data
derived from testing of the specific formulation proposed for (re)registration.
e. Mosquitoes
Registrants desiring duration claims of more than two hours will be required to
submit formulation specific data.
f. Stableflies
Deet products, of any formulation type and containing 10% or more active
ingredient, may bear claims for stablefly repellency. Sufficient data are
available to allow for a general, limited duration claim. Utilizing the
previous logic for mosquitoes, products containing 10% or greater concentration
•of Deet active ingredient may claim "repels Stableflies for up to two hours."
Registrant who wish to put this claim on their labels must also include a brief
statement to the effect that the duration of protection may vary with the
individual and that re-application may be required. Registrants desiring
duration claims for periods longer that two hours will be required to submit
-------
-72-
fbrmulation-speciffc data.
0. Labeling
1. Use Sites
a. Human Skin, Clothing, Tents and Bedrolls
Claims may be made for biting flies, chiggers, deer flies, mosquitoes, fleas
and stableflies.
b. Treatment of Screens in Domestic Dwellings
Claims for screen application may only be made for mosquitoes, ceratopogonid
species, and black flies.
2, Target Pests
a. Blade flies
Data currently available clearly indicate that Deet is effective in repelling
black flies. The data also indicate efficacy of various doses and
formulations. The Agency, therefore, will set limits on product labels. The
lower limit of formulations tested was 15%, so the Agency will not accept
efficacy claims for products containing less than 15% Deet as the sole active
ingredient. Because of the limits of the data reviewed, the Agency cannot
prescribe claims of product duration for all formulations, strengths and
types. The Agency will require formulation-specific data in cases where
producers wish to make a claim. i
b. Deerflies j
Given the extreme variation in protection times for different species, the
Agency will not accept duration claims for deerflies. Duration claims for
deerfly protection, therefore, will be refused for Deet products. Deet
formulations containing 10% or more active ingredient however, may bear a
limited, general claim for deer fly repellency.
c. Leeches
Because there are no terrestrial leeches in the U.S., the Agency does not
believe that the public interest would be served by permitting these claims on
consumer product labeling. In the past, there have been occasions where these
products were required for use by Anerican military forces. The Agency is
prepared to permit the labeling of products for terrestrial leeches with the
qualification that all such products bear the statement "For Use in Tropical
Areas Where Pest Occurs."
d. Mosquitoes
Deet products of any formulation or type, containing 10% or more active
ingredient, may bear claims for mosquito repellency. With regard to duration
claims, the Agency will not prescribe claims for all variations of formulation
strengths and types. There do appear, however, sufficient data to allow for a
general, limited duration claim. Products containing 10% or greater
concentrations of Deet may claim "repels mosquitoes for up to two hours."
J
-------
-73-
Registrants desiring to put this claim on their labels must also include a
brief statement to the effect that the duration of protection may vary with the
individual and that re-application maybe required.
-------
-74-
APSENOIX I
SOTPOPUNG COMPAQ EFFICAOf DATA
e a
a a a* a 41
•»< o a 4) ••« Q i—
-« O. a u ••« — a u i**
-------
-75-
APPENDIX I
SUPPORTING COMPANY EFFICACf DATA
e «
• O a a «
41 00 a 41 41 f*
«•« o a 4i *•* O "•
— i o. a u -* ** a _ « IM
jt jj •»« oo
-------
-76-
APPENOIX I
SUPPORTING COMPAttt EFFICaCf OAXA
a Q
4) BO
~* Q
** a. i
a u so w
a u a -4 a
— i 41 a. js 4i
CITATION
Hercules
(197?)
00001063
Hercules
( 1957)
00001025
Hercules 7
(1961)
01)001105
Kaegan et.al.
(1964)
00001034
Xaegan et.al.
(1964)
00001035
Kiran ec>&l>
(1972)
00001163
Lahr
(1970)
00001103
I^hr
(1970)
00004863
Lahr
(1970)
00004869
x
X
X
X
X
x
<8
41
Cu
...
a
a
s
u
41
41
X
X
a
X
X
X
X
X
X
X
.
JO
u
«n
X
X
X
X
u
H
*., -*--_..— .
-------
-77-
APPENDXX X
SUPSORTXNS COMPANY EFFICACZ DMA
e a
a e a m a
a a> « •*<
••* o a « „ ••* o M
** o. a u —4 ** ow>u
** o « « »» tu « .^ 4J
jt u ^4 ea*M a a .c a — a
u a o «a w a a u a*^j je
awo>*4 « «i 3 «t a a u
** a G. js « -^ o 4) o w »<.
'-T^V^ON «o- u .a . h = J =.« H
Iwihr
(1970)
00004870
I^hr
(1972)
00001124
X*dDAX
(1968)
00001110
TrfTimx
(1968)
00004365
Lomax
( 1969)
00001118
]^rtnt^y
(1970)
00001115
Lomax
(1970)
00001117
Mace
( 1966)
00001084
McAndlass
(1974).
00001037
X
2
X
X
X
X
X
•
' '
X
X
X
X
X
•*•
X-
X
X
X
X
X
X
X
X
X
X
X
X
X
X
*
-
-------
-78-
APPENDEC Z
CQMPAtir EZTicaar DATA
TTTkTTPN
HOC Co.
I ( 1957)
00001055
j
; HOC Co.
( 1974)
00001053
Miller
(1955)
00001000
Hitchall
( 1971 )
00001129
Neumiller
(1972)
00001072
Pierce
(1958)
00001104
S.C.Johnson
( 1964)
00001163
S.C. Johnson
(1969)
00001170
S.C. Johnson
(1974)
00001095
Q
41
•**
^4
a.
U at
X
•
a
u
4)
ao
00
*«4
^2
u
X
'
*
.
a
41
f*
*w
u
41
41
a
x
X
a
-------
-79-
APPEHDIX X
SOWOKTINS COMSAMC EBTICACJf OAXA
e • «
• O « s> 4)
41 CO a 4) 41 •»*
.* O « 4» — O ' •*
.- a. 4) •* «u 41 ~» 41
.* 44 -* oo «** a- 41 £ 3 —
-------
-80-
APPENDCC I
SUPPORTING COMPANY EFFXCACZ DATA
"
~
*
CITATION
Union Carbide
(1970)
00001107
r Union Carbide
* (1970)
00001111
Union Carbide
(197D :•'.
00001177 V
U*S-O.A;
( 1959)
00001165
WARF
(1960)
000010040
• WARF
(1960)
00001041
WARF
(1963)
. 00001030
WARF
{ 1964)
00001046
WARF
( 1964}
00001047 .
a
4>
<•*
f^
*M
j^
Q
a
a
X
e
o
o
a. a
O 41
oj a
U 41
a a
u a
X
X
X
01
u
41
00
ea
^
U
x
'
f
a
41
•«*
^4
44
U
41
41
a
X
X
X
01
a
41
B>
._
«
41
•«*
^4
44
41
01
3
£
X
a
4)
^j
U
41
41
a
41
a
4J
•«4
3
or
a
Q
"— S '
* "X
X
X
X
X
X
X
X
01
41
•*4
prt
*44
41
^
<3
w
en
x
X
X
X
X
a
u -
H
X
-------
-81-
VIII. CASE BIBLIOGRAPHY
Guide to Use of This Bibliography
1. Content of Bibliography. This bibliography contains citations of all
— the studies reviewed by EPA in arriving at the positions and conclusions
stated elsewhere in this standard. The bibliography is divided into 3
sections: (1) citations that contributed information useful to the re-
view of the chemical and considered to be part of the data base supporting.
registrations under the standard; (2) citations examined and ..judged to be
inappropriate for use in developing the standard; and (3) standard
- reference material. Primary sources for studies in this bibliography have
. been the body of data submitted to EPA and its predecessor agencies in
support of past regulatory decisions, and the published technical
literature. ----- .
2. Units of Entry. The unit of entry in this bibliography is called a--
•study". In the egg? of published materials, this corresponds closely to .
an article. In the case of unpublished materials submitted to the Agency,
the Agency has sought to identify documents at a level parallel to a
published article from within the typically larger volumes in which they
were submitted. The resulting "studies" generally have a distinct title
(or at least a single subject), can stand alone for purposes of review, and
can be described with a conventional bibliographic citation. The Agency
has attempted also to unite basic documents and commentaries upon them,
treating then as a single study.
3. Identification of Entries. Tfca entries in this bibliography are sorted
by author, date of the document, and title. Each entry bears, to the left'
of the citation proper, an eight-digit numeric identifier. This number is
unique to the citations, and should be used at any time specific reference
is required. This number is called the "Master Record Identifier", or
"MRID". It is not related to the six-digit "Accession Number" which has
been used to identify volumes of submitted data; see paragraph 4(d) (4)
below for a further explanation. In a few cases, entries added to the
bibliography late in the review may be preceded by a nine-character
temporary identifier. This is also to be used whenever a specific
reference is needed.
4. Form of the Entry. In addition to the Master Record Identifier (MRID),
each entry consists of a bibliographic citation containing standard elements
followed, in the case of materials submitted to EPA, by a description of
the earliest known submission. The bibliographic conventions used reflect
the standards of the American National Standards Institute (ANSI), expanded
to provide for certain special needs. Some explanatory notes of specific
elements follow:
a. Author. Whenever the Agency could confidently identify one, the
Agency has chosen to show a personal author. .When no individual was
identified, the Agency has shown an identifiable laboratory or
testing facility as author. As a last resort, the Agency has shown
the first known submitter as author.
-------
-82-
; ' b. Document Date. When the date appears as four digits with no
j question marks, the Agency took it directly from the document;
; four-digit date is followed by a question mark, the bibliographer'
! deduced the date from evidence in the document. Wien the date appears
"' "' ' ' as (19??), the Agency was unable to determine or estimate the date of
; the document. ....."
i
j c. Title. This is the third element in the citation. In some cases
I it has been necessary for Agency bibliographers to createror enhance a
:\ '~ ~~ '" -' document title. Any such editorial insertions are contained between V
square brackets.
d. Trailing Parentheses. For studies submitted to us in the past,
the trailing parentheses include (in addition to any self=exptanatory-
- -- • text) the following elements describing the earliest known, submission:
(1) Submission Date. Immediately following the word 'received1
appears the date of the earliest known submission. ~ —
(2) Administrative Number. The next element, immediately
following the word 'under', is the registration number, ~
experimental permit number, petition number, or other
administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter, fallowing the
the phrase 'submitted by'. Wien authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification. The final element in the trailing
parenthesis identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-
digit accession number follows the symbol 'CDL', standing for
"Company Data Library*. This accession number is in turn
followed by an alphabetic suffix wihich 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.
-------
Section I
Farm Chemical Handbook. (1979) Meister publishing. Willoughby. . Ohio.
The Federal Insecticide, Fungicide, and Rodenticide Act, as amended in 1978,
7th U.S. Code, Chapter 135, 61 Statute 163.78 Statute 190. . . •r-.
Pesticide Process Encyclopedia, 1977 Noyes Data Corp., Park Ridge, New ^^
Jersey. .
Pesticide Index: Basic information on the chemicals used as active
components o£ pesticides.; Martin, H., and Worth ing ton", C^R., eds.,~1977;
5th ed., British Corp. Protection Council, Wbrcestershire, England. ~ '~
U.S.'Environmental Protection Agency (1978a); Proposed Guidelines for Regis-—-
taring Pesticides in the United States. Federal Register, 43 (132).29696.
U.S. Environmental Protection Agency (1978b); Proposed Guidelines for Regis--
tering Pesticides in the United States; Hazard Evaluation: Humans and
Domestic Animals. Federal Register, 43(163) 37336.
U.S.'Environmental Protection Agency (1980); Regulations for the Enforcement of
the Federal Insecticide, Fungicide, and Rodenticide Act, Title 40, Chapter
1, Part 162.
U.S. Environmental Protection Agency (in press) Proposed Guidelines for Regis-
tering Pesticides in the United States. Subparts G (Product Performance)
H (Label Development). ' _
-------
Section II
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Standard
MRID
05002553
GSCOC2014
00001008
05000251
00001152
00001063
00001025
00001036
05000048
PRODUCT CHEMISTRY
CITATION
Blaine, R.L.; Levy, P.F. (1974) The use of thermal evolution
analysis (TEA) for the determination of vapor pressure of
agricultural chemicals.
Bogardr T. 1976. Information on manufacturing process of deet. .
(Unpublished data submitted by MGK Co., June I, 1976.)
Cutter Laboratories (1975) Diethyltoluamide: Analytical Test
Methods: [Gas chromatography dated Sep 1973 and IR
spectroscopic determination dated Feb 1975].- (Unpublished
study received Jun 11, 1975 under 121-17; CDL:106519-A)
Ellis, L.C.; Rise, M.A., inventors; Virginia Chemicals, Inc.,
assignee (1972) Verfahren zur Herstellung von N,N-Qiethyl-m-
Tuluamid in Waebrigger Atzalkaliloesung. [N,N-diethyl-m-
toluamide] GDY 2, 153, 307. ;May 4. 13p. Int. Cl-2 AOIH 9/20
Hercules Incorporated (1972) Properties: Physical and Chemical:
[Metadelphene]: AP-105B. (Incomplete study, p. 2; unpublished
study received Jun 12, 1972 under 11525-12; submitted by
Peterson Puritan, Inc., Danville, 111.; CDL"004536-£)
Hercules Incorporated (19??) Metadelphene(R): The Ail-Purpose
Insect Repellent: Bulletin AP-105B. (Unpublished study
received Jul 7, 1969 under 1516-52; submitted by Curts
Laboratories, Inc., Kansas City, Mo.; CDL:024967-B)
Hercules Powder Company (1957) Meta Delphene 'The Complete Insect
Repellent.* Wilmington, Del., He reviles Povder Co., Inc.
(Bulletin No. 213; Also In unpublished submission received
Aug 13, 1957 under unknown admin, no.; submitted by Hercules
Powder Co., Wilmington, Del.; CDL:108471-A)
Pfizer, Incorporated (1976) Product Chemistry for Technical
Chemical: Deet Insect Repellent. (Unpublished study that
includes manufacturing process and analytical methods,
received Sep 13, 1976 under 1007-27; submitted by Pfizer,
Inc., New York, N.Y.; CDLi226112-A)
Sarmiento, R.; Beroza, M. (1975) Analysis of the insect repellent
deet and its isomers by gas chromatography on graphitized
carbon black. Journal of Economic Entomology 68(2): 258-260
-------
00001100 S.C. Johnson & Son, Incorporated (1977) Chemical and Physical
Properties [of Oiethyltoluamide]: Summary. (Unpublished
study received Mar 21, 1978 under 4822-160; CDL:233261-5).
-05000597 Voronkina, T.M.; Latyshev, V.I.; Zhukova, E.V.; Yudina, -
I.P;Sakodynskii, K.I. (1971) Khronatografiya v
opredeleniinekotorykh repellentov i ikh primesei :
[cnronatography in the determination of some (insect)
-'-' '- repellents and their impurities] Trudy, Vsesoyuznyi Nauchro-_
Issledovatel ski InstitutVeterinarnoi Sanitatii 39:189-192...,
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting.
Registrations Under the Standard
ENVIRONMENTAL FATE
MRID
GS0002001
GS0002002
GS0002003
CITATION
Hales, Y. and H.E. Radtke Jr. Use Data Related to Exposure for
Deet. GEOMET Technologies, Inc., under Contract §68-01-5155
S.C. Johnson & Son, Inc. 1979. Consumer Exposure & Use Rates of
Insect Repellents. (This study includes confidential business
information.)
S.C. Johnson & Son, Inc. 1980. DEET Consumer Use Information.
(This package contains studies using confidential business
information.)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting:
Registrations Under the Standard
MRID
00001051
00001102
GS0002016
GS0002004
05000001
05000002
TOXICOLOGY
CITATION
Ambrose r A.M., Huffman, O.K., and Salamone, R.T. .1959
Phannacologic and toxicologic studies on N,N-diethyltoluamide:
I. N,N-Dietnyl-m-toluamide. Tbxicol. Appl. Pharmacol.l(l):97-
115. (MRID: 05000240. 17A-0036) (Also in unpublished
submission received Oct. 22, 1974 under 1021-1323; prepared by.
U.S. Amy Environmental Health Lab., Toxicology Div. ,
submitted by McLaughlin Gormley King Co., Minneapolis, Minn;
CDI:028339-B) ~.
Ambrose, AJ1., Yost, D.H. 1965 Phannacologic and toxicologic
studies on N,N-diethyltoluamide: II. N,N-Diethyl-o-toluamide
and N,N-Diethyl-p-toluamide. Tbxicol. Appl. Phannacol. 7(6):
772-780 (MRID: 00001102, 17A-0023) (Also in unpublished
submission received Mar 21, 1978 under 4822-160; prepared by
U.S. Army Environmental Health Agency, Toxicology Div., in
cooperation with U.S. Army Medical Research Laboratory,
Pathology Div., submitted by S.C. Johnson & Son, Inc., Racine,
Wis.; CDI:233262-C)
Bellies, R.P., and HORN, H.J. 1967. Acute Oral Toxicity to Rats
of 2370D-89: Repeated Dermal Application to Rabbits and
Single Application to the Eyes of Rabbits. (Unpublished study
that includes tables 1-21 and appended letter, received Jul
10, 1976, under 4822-10; prepared by Wbodard Research Corp.,
submitted by S.C. Johnson and Son, Inc., Racine, Wis.;
CDL: 233491-0)
Blau, S.J. , and KANOF, N. 1961. CDK 79/2—88/1: Patch Tests:
DEET. (Unpublished study that includes letter, received
December 19, 1961, under 6650-1; submitted by Revlon, Inc.,
Bronx, N.Y.; CDL:229503-B)
Blomquist, L., Stroman, L., and Thorsell, W. 1975, Distribution
and fate of the insect repellent 14C-N,N-diethyl-m-toluamide
in the animal body: I. Distribution and excretion after
injection into mice. Acta Phannacol. Tbxicol. 37:121-133
(MRID: 05000001, 17A-0033)
Blomquist, L., and Thorsell, W. 1977, Distribution and fate of
insect repellent 14C-N,N-diethyl-m-toluamide in the animal
body: II. Distribution and excretion after cutaneous
application. Acta Phannacol. Tbxicol. 41:235-243 (MRID:
05000002. 17A-0038)
05000243
Carpenter, C.P. , Weil, C.S. and Smyth, H.F., Jr. 1974,
finding toxicity data: List VIII. Tbxicol. Appl.
Phannacol. 28:313-319 (MRID: 0500243. 17A-0024)
Range-
-------
00001139 Davidow, B. I960, Lee's Sports' Balm: Acute Oral Tbxicity,
Primary Irritation, Acute Dermal Toxicity, Eye Irritation.
(Unpublished study that includes tables 1-5, received June 14,
I960, under 7165-1; prepared by New Drug Institute, submitted
by William W. Lee and Co., Inc., Watervliet, N.Y.; CDL:OS0672-
A) (MRID: 00001139, 174-0021c)
GS0002005 CUrloo, R.S., and Wbodard, M.W. 197la. Safety Evaluation by
Repeated Dermal Application to Rabbits: Formulation 3369D138
and Formulation 336SD139. (Unpublished study that includes
tables A-l—A-10, received September 9, 1971, under 4822-114;
prepared by Wbodard Research Corp., submitted by S.C. Johnson
and Son, Inc., Racine, Wis.; CDL:133553-C)
GS0002006 Durloo, R.S., and Wbodard, M.W. 1971b. Safety Evaluation-by Test
for Irritation in Rabbits: Formulation 3369D135-1.
(Unpublished study that includes tables A-l—A-15 and
toxicology data, received September 9, 1971, under 4S22-RRU
(114); prepared by Wbodard Research Corp., submitted by S.C.
Johnson and Son, Inc., Racine, Wis.; GEL:133553-8)
GS0002007 - Evers, W.D. 1969. The Dermal Toxicity of Insect Repellent Gel D-
554-9: Report No. WOE 69:11. (Unpublished study received
February 12, 1969, under 134-48; submitted by Hess and dark,
Research Department, Division of Richardson Merrell, Inc.,
Ashland, Ctuo; CDL:000602-fl)
05003588 Feldmann, R.J., and Maibach, H.I. 1970. Absorption of some
organic compounds through the skin in man. J. Invest.
Dennatol. 54-399-404 (MRID: 05003588, 17A-0005)
05000134 Ficsor, G., Nil, L.O.; and Piccolo, G.M. 1972. Survey of
pesticides for mutagenicity by the bacterial-plate assay
method. E.M.S. Newsletter 6:6-8 (MRID: 05000134, 17A-0026)
05000061 Gleiberman, S.E., and Volkova, A.P. 1974. [Comparative toxicity
of diethyltoluamide synthesized on petroleum and coal
metaxylol.] NTIS AD/A-000 176 (Translated from Russian)
(MRID: 05000061, 17A-0008)
05000007 Gleiberman, S.E., Volkova, A.P., Nikolaev, G.M., and Zhukova,
E.V. 1975. [Bnbryotoxocity of the insect repellent diethyl-
toluamide.] Farmakol. Toksikol. 38:202-205 (Translated from
Russian) (MRID: 05000007, 17A-0027)
05000008 Gleiberman, S.E., Volkova, A.P., Nikolaev, G.M., and Zhukova,
E.V. 1976. [Study of the remote results of the use of
repellents: I. Experimental study of the effects remote
results of long-term exposure to the repellent
diethyltoluamide (DEBT).] Med. Parazitol. (Mosk.) 45:65-69
(Translated from Russian) (MRID: 05000008, 17A-0010)
-------
00001063
05000328
GS0002008
00001080
00001073
00001039
05000271
05002807
050023008
GS0002036
Grahwit, G., Sterner/ W., and Chibanguza, G. 1977. Effect of
"MGK Diethyltoluami de" on the Embryonic Developnent of Rats
after Oral Application. (Unpublished study that includes
appended letter, received May 23, 1977, under 1021-891;
prepared by International Bio-Research, Inc., submitted by
Mclaughlin Gormley King Co., Minneapolis, Minn.; CDL:230396-A)
(MRID: 00001063, 17A-0028)
Gryboski, J., Weinstein, D., and Ordvay, U.K. 1961. Toxic
encephalopathy apparently related to the use of an insect. .
repellent. N. Engl. J. Ned. 264:289-291 (MRID: 05000328,
17A-0029)
Horn, H.J. 1968. Repeated Dermal Application to Rabbits
2693D102. (unpublished study received Jul 10, 1976, under -
4822-10; prepared by Wbodard Research Corp., submitted by 1
S.C. Johnson and Son, Inc., Racine, Wis.; CDL:233491-E)
Howard, D.J.; Woodard, M.W. (1971) Acute Oral Toxicity to Rats:
Ebrmulation 33693135-1. (Unpublished study that includes
toxicology data, received Sept 9, 1971 under 4822-114;
prepared by Woodard Research Corp., submitted by S.C.
Johnson & Sons, Inc., Racine, Wis.; CDL:133553-A)
Johnston, C.D. (1972) Safety Evaluation by Acute-Dermal
Irritation Test in the Rabbit: 3560D105-1 and 3560D138-2.
(unpublished study that includes tables and formulations,
received Jun 12, 1972 under 4822-119; prepared by Woodard
Research Corp. submitted by S.C. Johnson & Son, Inc., Racine,
Wis.; CTL:007514-B)
Jolly, E.R.; Sloughfy, C.A. (1974) Irritation and Sensitization
Potential of Insect Repellent: Final Report: IC-1433.
(Unpublished study received Feb 16, 1977 under 1021-567;
prepared by Bicnetric Testing, Inc., submitted by McLaughlin
Gormley King co., Minneapolis, Minn.; CDL:228664-A)
Kingscote, A.A., and Allen, J.R. 1959. The fate of Insect
Repellents Applied to Skin. (Unpublished study received
August 4, 1960, under CRB Extra-Mural) (MRID: 05000271,
0030)
17A-
Kurasova, V.V., and Leschev, V.V. 1969. [Toxicity of benzimine,
diethyltoluami de, and carboxide for rabbits and cattle during
their external application.] Tr. Vsesoy. Nauch. lasled,
Inst. Vet, Sanit, 33:235-245 (Translated from Russian) (MRID:
05002807, 17A-0011)
Lamberg, S.I., and Mulrennan, J.A., Jr. 1969, Bullous reaction to
diethyltoluamide (DET): Resembling a blistering insect
eruption,.. Arch. Dermatol. 100:582-586 (MRID: 050023008,
17A-0012)
Litton Bionetics, Inc. 1977. Mutagenicity Evaluation of
Diethyltoluamide technical. Final report submitted to the
U.S. Army, Project 120838.
-------
GS00020Q9 Lukes, T.H., and PAA, H. 1975. 90-Day Subacute Dermal Tbxicity
Study with 3989BN69-1 in Albino Rabbits: IBT No. 601-06046.
(Unpublished study that includes tables I-XLIX, received July..
10, 1976, under 4322-10; prepared by Industrial Bio-Test.
Laboratories, Inc., submitted by S.C. Johnson and Son, Inc..,.
Racine, Wis.; CDL:233491^J) " .
050Q020 ' Lure, A.A., deiberman, S.E., and Tsizin, tS. 1978. [Pharmacoki-
~ - netics of the repellent N,N-diethyl-3-methyl-benzaraide.] Med..
Parazitol. (Mosk.) 47:72-77 (Translated from Russian) (MRID:
0500020, 17A-0000)
05CQ0021 Maibach, H.I., and Johnson, H.L. 1975. Contact urticaria
syndrcme: Contact urticaria to diethyltoluamide--imnediate-
type hypersensitivity. Arch. Dermatol. 111:726-730 (MRID:
05000021, 17A-0031)
05000599 Markina, V.V. and Yatsenko, V.K. 1971. [A comparative evaluation
of the absorbability of the repellents diethyltoluamide,
benzimine, and carboxide in the form of lotions and creams]
Zdravookhr. Turkmen. 15:41-44 (Translatedfrom Russian)
(MRID: 05000599, 17A-0014)
GS0002010 Pesticide Incident Monitoring System (PIMS). 1978. Sunnary of
Reported Pesticide Incidents Involving CEET. Report No. 121.
Human Effects Monitoring Branch, Office of Pesticide Programs,
U.S. Environmental Protection Agency, Washington, D.C.
05000242 Phillips, L., Jr., Steinberg, M., Maibach, H.I., and Akers, W.A.
1972. A comparison of rabbit and human skin response to
certain irritants. Toxicol. Appl. Pharmacol. 21:359-382
(MRID: 05000242, 17A-0032)
05000693 Rabinovich, M.V. 1966. (The effect of diethyltoluamide on the
human skin and mucous membranes of the eyes.] Zh. Mikrobiol.
Epidemiol. Immunobiol. 43:109-112 (Translated from Russian)
(MRID: 05000693, 17A-0016)
05000174 Schmidt, D.H., Acree, P., Jr., and Bovman, M.C. 1959. Fate of
Cr diethyltoluamide applied to guinea pigs. J. Econ.
Entomol. 52:928-930 (MRID: 05000174, 17A-0017)
GS0002011 Seater, S., and Horn. H.J. 1967. Repeated Dermal Application to
Rabbits and Single Application to the Eyes of Rabbits of
2370D89, 2539D91-1, and 2539D91-3. (Unpublished study that
includes tables, received July 10, 1976, under 4822010;
prepared by Wbodard Research Corp., submitted by S.C. Johnson
and Son, Inc., Racine, Wis.; CDLi233491-F)
05007487 Spencer, T.S., Hill, J.A., Feldman, R.J., and Maibach, H.I.
1979. Evaporation of diethyltoluamide from hunan skin in vivo
and in vitro. J. Invest. Dermatol. 72:317-319 (MRID:
05007487, 17A-0034)
-------
05000045 Stenbaeck, P. (1977) Local and systemic effect of commonly used
agents: Lifetime studies of 16 compounds in mice and rabbits.
Acta Pharmacologica et Toxicologica 41 (5):417-431
05001247 Swentzel, K.C. 1977. Investigation of N,N-Diethyl-m-toluamide
(M-OET) for Dominant Lethal Effects in the Mouse. Aberdeen '-
Proving Ground, Md.; U.S. Army Environmental Hygiene Agency
(USAEHA Study No. 51-0034-78, available from NTIS,
Springfield, Va.; AD-A508 414/4GA) (MRID: 05001247, 17A-
0019)
GS0002021 U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special study No. 75-51-0034,80.
Appendix I: Investigation of N,N-Diethyl-M-toluamide (M-OET)
for Dominant Lethal Effects (17D-0008) .;.-_"-
GS0002022 U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent
N,N-diethyl-meta-toluamide. Special Study No. 75-51-0034,80.
Appendix J: Mutagenicity Evaluation of Diethyltoluamide
Technical Grade LB-468-77 Lot No. 7141 (170-0009)
GS0002023 U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,80.
Appendix P: Prenatal Toxicity in Rabbits (170-0015)
GS0002024 U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,80.
Appendix S: Determination of Metabolites of M-OET in Urine of
Rabbits (170-0018)
GS0002025 U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,80.
Appendix B: Protocol-Primary Eye Irritation (170-0001)
I
GS0002026 U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,80.
Appendix A: Protocol-Primary Skin Irritation (170-0000).
GS0002027 U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study 75-51-0034,80.
Appendix C: Primary Eye Irritation (170-0002)
GS0002028 U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,80.
Appendix D: Photochemical Skin Irritation-Evaluation Protocol
(170-0003)
-------
GSOQ02029
GS0002030
CS0002031
GSOQ02032
GS0002033
GSQ002034
GSQ002035
GS0002036
00001093
00001099
U.S. Amy Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,30.
Appendix E: Protocol LD5Q Determinations (Dermal) (170-0004)
U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N- _- . . .
diethyl-meta-toluamide. Special Study Mo. 75-51-0034,80.
Appendix F: Acute Oral LD5Q Determinations (17D-0005) '— —_.
U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,80.
Appendix H: Protocol-Guinea Pig Sensitization Test (17D-0007)
U.S. Army Environmental Hygiene Agency. 1979. Preliminary _
assessment of relative toxicity of insect repellent N,N- : . -
diethyl-tneta-toluamide. Special Study No. 75-51-0034,80.
Appendix K: Protocol-Saturated Vapor Inhalation Toxicity Study
(170-0010)
U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,80. "
Appendix L: Protocol-Acute Aerosol Inhalation Toxicity
(17D-0011)
U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,-N-
diethyl-tneta-toluamide. Special Study to. 75-51-0034,80.
Appendix M: Inhalation Toxicities of N,N-diethyl-neta-
toluamide (M-OET) (170-0012)
U.S. Army Environmental Hygiene Agency. 1979. Preliminary
assessment of relative toxicity of insect repellent N,N-
diethyl-meta-toluamide. Special Study No. 75-51-0034,80.
Appendix Q: Dermal Penetration of 14C- labeled M-OET (17D-0016)
U.S. Army Environmental Hygiene Agency. 1980. Effect of Dermal
Application of N,N-Oiethyl-Meta-Toluamide (M-OET) on the
Enbryonic Development of Rabbits. Study No. 75-81-0034-80.
Vos, B.J. (1972) Insect Repellent Off. Repeated Insult Human
Patch Test, (unpublished study that includes table, received
July 10, 1976 under 4822-10; prepared by Woodard Research
Corp., submitted by S.C. Johnson & Son, Inc., Racine,
Wis.; CDL:233491-K)
WARP Institute, Incorporated. 1974. Spray in Eye Irritation of
4071 D9-3: WARP No. 4044151. (Unpublished study received Aug
7, 1974 under 4822-138; submitted by S.C. Johnson & Son, Inc.,
Racine, Wis.; CDL; 140048 -B) . File No. 00001099 (AA0085)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting.
Registrations Under the Standard
EFFICACY
MRID CITATION -;: . -
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5Q.Q.Q1172 Altaian, R.M. (1969) Repellent tests against Anopheles albimanus
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05002987 Bar-Zeev, M.; Ben-Tamar, D. (1971) Evaluation of Mosquito
repellents. Mosquito News 31(1):56-61.
05000216 Bar-Zeev, M.; Ben-Tamar, D.; Gothilf, S. (1974) Field evaluation
of repellents against mosquitoes in Israel. Mosquito News
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05000201 Bar-Zeev, M.; Gothilf, S. (1972) Laboratory^evaluation of
flea repellents. Journal of Medical Entomology 9(3):
215-218.
05000173 Bar-Zeev, M.; Schmidt, C.H. (1959) Action of a repellent as
indicated by a radioactive tracer. Journal of Economic
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05000172 Bar-Zeev, M.; Saith, C.N. (1959) Action of repellents on
mosquitoes feeding through treated membranes or on treated
blood. Journal of Economic Entomology 52(2):263-267.
05000284 Berry, R.; Joseph, S.R.; Langford, G.S. (1965) The question of
area mosquito repellents. Pages 190-193, In New Brunswick,
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-------
05002313 Boparai, M.S.; Varma, R.N. (1971) Field evaluation of
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05000093 Bukshytnov, V.I. (1964) Comparative tests of repellents for.
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Nauchno-Issledovatel'skii Institute Veterinarnoi Sanitarii..
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-------
G50002012 WARF Institute, Inc. 1975a. Acute Oral LDStt (Male.and Female),. ..
Skin and Eye Irritation, Acute Inhalation LD50 of 4235D11I-1:
WARF No. 5030701. (Unpublished study that includes tables I-'
II, received July 10, 1976, under 4822-10; submitted by S.C.
Johnson and Son, Inc., Racine, Wis.; GEL:233491-C)
00001085 WARF Institute, Inc. 1975b. Acute Oral HX- (Male and Female),
Skin and Eye Irritation, Eye Irritation (Direct Spray) of
-.--••-- 3872D102: WARF No. 4122920. (Unpublished study that includes
-- - "-• tables I-II, received July 10, 1976, under 4822-10? submitted .
by S.C. Johnson & Son, Inc., Racine Wis.; CEL:233491-B).
(MRID: 00001085, 17A-0022c)
00001101 - WARF Institute, Incorporated. (1976). Summary of Toxicology Data
on Insect Repellent 4315D81-2. (Unpublished study that
:r „- includes WARF No. 5120760, received Mar 21, 1978 under 4822- ..
160; CDL:233262-A) File No. 00001101 (AA0100). :;
05000047 Wong, M.H.; Yew, D.T. (1978) Dermotoxicity of the mosquito
repellent related to rabbit ears. Actu Anatomica 100(1): 129-
131 =
GS0002013 Woodard, G. 1959. Meta Delphene: Toxicity; by Repeated Oral and
Dermal Administration. (Unpublished study that includes
charts 1-101, tables 1-125, plates 1-201, reports with
sunnaries on rabbits and dogs, received October 1959, under
unknown administration nunber; prepared by Woodard Research,
submitted by Hercules Powder Co., Agricultural Chemicals
Division, Wilmington, Del.; GEL:133545-A)
00001043 Zabel, L. (1976) Acute Aerosol Inhalation Toxicity Study in Rats:
TL-1480, Code No. 369-76 Intermediate 2007: 1ST tta. 3562-
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-------
; OFFICE OF PESTICIDE PROGRAMS
] REGISTRATION STANDARD BIBLIOGRAPHY
f •" Citations Considered to be Part of the Data Base Supporting
\ Registrations Under the Standard
ECOLOGICAL
MRID CITATION .-— --•- -
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-------
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WI; CDL:127306-C).
-------
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New insect repellents: Part II-Clothing treatments. Soap and
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DE; CEL:022000-8).
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(Also In unpublished study received Oct 17, 1957 under
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-------
05000073 Dremova, V.P. (1967) Effektivnost* primeneniya nekotorykh
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... Meditsinskaya Parazitologiya Parazitarnye Bolezni. [Medical ~
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-------
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-------
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Study of the toxicity and repellent activity of diethyltoluamide
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-------
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-------
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-------
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Meditsinskaya Parazitologiya i Parazitarnye Bolenzi. [Medical
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05000198 Johnson, H.L.; Skinner, W.A.; Skidmore, D.; Maibach, H.I. (1968)
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duration off ring-substituted N,N-dialkyl-and amino-
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05002555 Kappor, D.; Paul, C.F.; Perti, S.L. (1972) Evaluation of certain
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05002665 Kashafutdinov, G.A. (1969) Znachenie pola nasekomykh i
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[Significance of the sex of insects and the effect of
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Uchenye Zapiski Kazanskogo Veterinarnogo Instituta. [Scientific
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-------
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-------
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-------
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-------
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-------
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-------
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-------
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-------
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-------
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-------
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-------
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Section III
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBIOGRAPHY
Examined and Judged to be Citations Inappropriate For Use_ in :
Developing the Standard
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-------
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-------
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-------
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-------
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-------
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