United Slates Office of March 1991
Environmental Protection Pesticide Programs
Agency
Reregistration
Eligibility Document
(RED)
Methoprene
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540/RS-91-128
REREGISTRATION ELIGIBILITY DOCUMENT
ISOPROPYL (2E,4E)-ll-METHOXY-3,7,ll-TRIMETHYL-2,4-DODECADIENOATE
(REFERRED TO AS METHOPRENE)
LIST A
CASE 0030
MARCH 1991
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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30373-101
REPORT DOCUMENTATION
PAGE
1. REPORT NO.
4. Title and Subtitle
Reregistration Eligibility Document (RED) - Methoprene
7. Authors)
EPA, Office of Pesticide Programs. Special Review & ReRea. Div.
3. *eclptenfs Accmln No.
1 Report Date
March 1991
•. Performing Organisation Rapt. No.
540/RS-92-12ft
t. Performing Offtaniiatlon Name and Address
U.S. Environmental Protection Agency
Office of Pesticide Programs
Special Review and Reregistration Division
401 M Street, S.W.
Washington, D.C. 20460
10. Prsiact/Taak/Worfc Unit No.
11. ControctfO or Grant(G) No.
(C)
(G)
12- Sponsoring Organization Name and Addrtii
same as #9
11 Type of KtpOft 4 Period C«vti«d
14.
IS. Supplementary Notes
lft. Abstract (Limit; 200 words)
EPA is directed by the Federal Insecticide, Fungicide, and
Rodenticide Act as amended in 1988 (FIFRA *88) to review all
pesticide products containing active ingredients initially
registered before November 1, 1984, and to reregister those
products that have a substantially complete data base and do not
pose unreasonable adverse effects to people or the environment.'-
This pesticide reregistration program is to be completed by th6
late 1990•s.
The Reregistration Eligibility Document (or RED) discusses
the scientific data and other information supporting EPA's j
regulatory conclusion that products containing a pesticide do not
pose unreasonable risks when used as directed by Agency-approved
labeling, and are eligible for reregistration.
17. Document Analytic a. Descriptor*
Pesticides, standards regulations, manufacturing, chemistry, toxicology,
residues, ecology, path of pollutants.
b. Identiften/Open-Ended Terms
c. COSATI Field/Group
1ft. Availability Statement
Publicly Available
19. Security Clasa (Thh Report)
unclassified
20. Security Claat (This Page)
unclassified
21. No. of Pace*
47
22. Price
(See ANSI—Z39.16)
See InttrueiionM on Rtvrim
OPTIONAL FORM 272 (4-77)
(Formerly NTIS-35)
Department of Commerce
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TABLE OF CONTENTS
GLOSSARY OF TERMS AND ABBREVIATIONS
EXECUTIVE SUMMARY
PAGE
iii
v
I. INTRODUCTION 1
II. ACTIVE INGREDIENTS COVERED BY THE REREGISTRATION DECISION 2
DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT 2
B. USE PROFILE 2
C. REGULATORY HISTORY 3
III. AGENCY ASSESSMENT OF ACTIVE INGREDIENT 5
A. PRODUCT IDENTIFICATION i>
B. HUMAN HEALTH ASSESSMENT 5
1. TOXICOLOGY DATA 5
a. ACUTE TOXICITY 5
b. SUBCHRONIC TOXICITY &
C. CHRONIC TOXICITY 7
d. ONCOGENICITY 7
e. DEVELOPMENTAL TOXICITY AND REPRODUCTION 3
f. MUTAGENICITY 8
g. METABOLISM S
2. DIETARY EXPOSURE 9
a. RESIDUE DATA 9
b. REFERENCE DOSE 11
_C. TOLERANCE REASSESSMENT 11
3. NON-DIETARY EXPOSURE 11
C. ENVIRONMENTAL ASSESSMENT 12
1. ENVIRONMENTAL FATE ASSESSMENT 12
2. ECOLOGICAL EFFECTS ASSESSMENT 12
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IV. REREGISTRATION DECISION FOR METHOPRENE 16
A. DETERMINATION OF ELIGIBILITY 16
B. ADDITIONAL GENERIC DATA REQUIREMENTS 17
C. LABELING REQUIREMENTS 17
V. PRODUCT REREGISTRATION 18
A. DETERMINATION OF ELIGIBILITY 18
B. PRODUCT-SPECIFIC DATA REQUIREMENTS 18
C. LABELING REQUIREMENTS 18
VI. APPENDICES
A. APPENDIX A - GENERIC DATA REQUIREMENTS FOR REREGISTRATION
OF METHOPRENE AND DATA CITATIONS SUPPORTING-
REREGISTRATION
1. GUIDE TO APPENDIX A !2 0
2. PRODUCT IDENTIFICATION 21
3. TOXICOLOGY 2 3
4. RESIDUE CHEMISTRY 24
5. ECOLOGICAL EFFECTS 2 5
6. ENVIRONMENTAL FATE 2 6
B. APPENDIX B - BIBLIOGRAPHY
1. GUIDE TO APPENDIX B 2 3
2. BIBLIOGRAPHIC CITATIONS 3 0
C. APPENDIX C - DATA CALL-IN
1. Attachment A
2. Attachment B
3. Attachment C
4. Attachment D
5. Attachment E
6. Attachment F
7. Attachment G
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
AD I
a. i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HDT
K+CWHR
LC50
LC50
LDT
LEL
MP
MPT
Acceptable Daily Intake. Also known as the Reference
-Dose or RfD.
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
I
Federal Food, Drug, and Cosmetic Act
Highest Dose Tested
Kernel plus Cob with Husk Removed
Median lethal concentration - a statistically derived
concentration of a substance that can be expected ::
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volu.-e
of water or feed, e.g., mg/1 or ppm.
Median lethal dose - a statistically derived single dcse
that can be expected to cause death in 50% of the test
animals, when administered by the route indicated (oral,
dermal, inhalation). It is expressed as a weight c:
substance per unit weight of animal, e.g.,m mg/kg.
Lowest Dose Tested
Lowest Effect Level
Manufacturing Use Product
Maximum Permissible Intake
i ii
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GLOSSARY OF TERMS AND ABBREVIATIONS CONT'D
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts per Million
RfD Reference Dose
RS Registration Standard
TMRC Theoretical Maximum Residue Contribution
iv
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EXECUTIVE SUMMARY
The Environmental Protection Agency first registered
methoprene" in" 1975 as a chemical pesticide, specifically as an
insect growth regulator. It is registered for use on a variety of
food and non-food sites including use in feed/mineral supplements
for cattle, on rice, pastures, stored tobacco, mushroom cultures,
in and around homes. It is also registered for use on non-crop
aquatic areas to control the horn fly, mosquito, cigarette beetle,
tobacco moth, sciarid fly, and flea larvae. Products which contain
methoprene as an active ingredient are eligible for reregistration
except the briquette (slow release) formulations.
The Agency issued a Registration Standard entitled, "Guidance
for the Reregistration of Pesticide Products Containing Methoprene
as the Active Ingredient" (NTIS PB87-109443) in February 1982. The
Registration Standard continued to classify the compound as a
conventional pesticide. Soon after the Registration Standard was
issued, the Agency reclassified the compound as a biochemical
pesticide. The classification of methoprene as a biochemical
pesticide was based on information concerning the mode of action
of methoprene and the chemical structure of methoprene. At thaf
time the Agency also eliminated many of the environmental fate data
requirements from the 1982 Registration Standard, since the tiered
testing of Section M rather than Section N of the guidelines apply
to biochemical pesticides.
The data base to support the reregistration of methoprene is
substantially complete. However, two generic data requirements are
being levied: octanol/water partition coefficient and an estuarir.e
invertebrate life cycle study. Although the former study is net
critical to the reregistration decision or environmental assessment
of methoprene at this time, the Agency is requiring this data to
satisfy this gap in the product chemistry data base for methoprene.
The latter study is needed to assess the long term exposure to
estuarine invertebrates. Although there is concern for the long
term exposure to estuarine invertebrates, the Agency has determined
that the reregistration of methoprene can precede at this tire
because most of the uses for methoprene do not involve significant
exposure to estuarine invertebrates. Only the use as a briquette
(slow release)"formulation raises a concern. The other aquatio
formulations are not expected to result in significant exposure
because methoprene is short lived in the aquatic environment ar.i
does not have a high potential for bioaccumulation. The estuarir.e
invertebrate life cycle study is required to confirm whether or not
the estimated exposure from the briquette formulation is sufficient
to pose an adverse effect on estuarine invertebrates.
v
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The current data base is sufficient to allow the Agency to
conduct a reasonable risk assessment for most registered uses of
methoprene. The data the Agency has supports the conclusion that
most uses of methoprene will" not result in unreasonable effects to
the environment. As mentioned above the only use of concern at
this time is t:ie long term exposure to estuarine invertebrates
through the use of the briquette formulation.
EPA has determined that all products containing methoprene as
an active ingredient are eligible for reregistration except the
briquette formulation which will be considered for reregistration
once the data requested in this document is submitted, reviewed,
and determined to cause no unreasonable risk to nontarget
organisms, specifically estuarine invertebrates.
Before reregistering each product, the Agency is requiring
product specific data and revised labeling to be submitted within
8 months of the issuance of this document. After reviewing these
data and the revised labels, the Agency will determine whether to
reregister a product based on whether or not that product meets the
requirements in Section 3(c)(5) of the Federal Insecticide,
Fungicide, and Rodenticide Act. ?
vi
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I. INTRODUCTION
In..1988, the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) was amended to accelerate the
reregistration of products with active ingredients registered
prior to November 1, 1984. The amended Act provides a
schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration
process. The first four phases of the process focus on
identification of data requirements to support the
reregistration of an active ingredient and the generation and
submission of data to fulfill the requirements. The fifth
phase is a review by the U.S. Environmental Protection Agency
(referred to as "the Agency") of all data submitted to support
reregistration.
Section 4 (g) (2) (A) of FIFRA states that in Phase 5
"the Administrator shall determine whether pesticides
containing such active ingredient are eligible for
reregistration" before calling in data on products and either
reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review
the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and ::
determine whether the pesticide meets the "no unreasonable
adverse effects' criterion of FIFRA.
This document presents the Agency's decision regarding
the reregistration of methoprene. The document consists of
five sections. Section I is this introduction. Section II
describes methoprene, its uses and regulatory history.
Section III discusses the human health and environmental
assessment based on the data available to the Agency. Secticr.
IV discusses the reregistration decision for methoprene and
Section V discusses product reregistration. Additional
details concerning the Agency's review of data are available
on request.1
EPA's reviews of specific reports and information on tbe-
set of registered uses considered for EPA's analyses xay
be obtained from: EPA, Freedom of Information, 401,
St., S.W., Washington, D.C. 20460.
1
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II. ACTIVE INGREDIENT COVERED BY THIS REREGISTRATION DECISION
A. IDENTIFICATION OF ACTIVE INGREDIENT
The following active ingredient is covered by the
Reregistration Eligibility Document:
Chemical Name: isopropyl (2E, 4E)-ll-methoxy-3,7,11-trimethyl-
2,4-dodecadienoate
(Referred to hereafter as methoprene)
Common Name: Methoprene
CAS Number: 40596-69-8
Office of Pesticide Programs Chemical Code Number: 1054C1
Empirical Formula: C19HJ403
Trade Name: Altosid", ZR-515, and ENT-70460 ^
Basic Manufacturer: Zoecon Corporation' #
B. USE PROFILE
Type of Pesticide: Biochemical Pesticide, Insect Growth
Regulator
Pests Controlled: Horn fly, mosquito, cigarette beetle,
tobacco moth, sciarid fly, flea larvae,
mealy bug, and spider mite.
Registered Use Sites:
Terrestrial Food Crop - Rice
Terrestrial Feed Crop - Pastures
Terrestrial Non-Food Crop - Compost/compost piles, v.ide
area/general outdoor treatment (public health use ,
ornamental herbaceous flowering/foliage/vine plants.
Aquatic Food Crop - Rice
Aquatic Non-Food Outdoor - Salt/brackish water
sites, intermittently flooded areas/water,
streams/rivers/channeled water,
swamps/marshes/wetlands/stagnant water.
Aquatic Non-Food Industrial - Drainage systems, sevaqe
systems.
Aquatic Non-Food Residential - Ornamental ponds/aquar,
swimming pool water systems.
Residential Outdoor - Compost/compost piles, ornamental
herbaceous flowering/foliage/vine plants.
Indoor Food - food/feed storage area-full, cereals
(manufactured), mushrocn houses/mushroom casing soil
2
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eating establishments, commercial shipping containers-
feed/ food-empty, food processing plant
premisses/equipment, dairy cattle (lactating),
beef/range/feeder cattle (meat).
Indoor Non-Food - Stored tobacco, commercial
transportation facilities, tobacco processing plant
premises/equipment, commercial/institutional/industrial
premises/equipment (indoor), horses (colts), ponies.
Indoor Medical - Hospitals/medical institutions premise
(human/veterinary)
Indoor Residential - Kennels and/or pet sleeping
quarters, household/domestic dwellings indoor premises,
cats (adults/kitten) (pet), dogs/canines (adult/puppies)
(pet).
Formulation Types Registered: Technical - 90% a.i.;
Formulation Intermediates (5% -
90% a.i)
Formulations: Granular/Impregnated Material, Pelleted-
Tableted; Emulsifiable/Soluble Concentrate, Pressurize^
Liquid (aerosol), Solution-Ready To Use.
Methods of Application: Ground spray, aerial spray, granular,
mineral block/pellet, slow release
briquette
C. REGULATORY HISTORY
The Agency first registered methoprene in 197 5 for use in
feed/mineral supplements for cattle, on rice, pastures , stored
tobacco, mushroom cultures, in and around homes, and also on non-
crop aquatic areas to control the horn fly, mosquito, cigarette
beetle, tobacco moth, sciarid fly and flea larvae.
The Agency issued a Registration Standard entitled "Guidance
for the Reregistration of Pesticide Products Containing Methoprene
as the Active Ingredient" (NTIS PB87-109443) in February 1982. The
Registration Standard classified the compound as a conventional
pesticide. Subsequently the Agency issued an Errata Sheet for
methoprene, classifying the compound as a biochemical pesticide.
The classification of methoprene as a biochemical pesticide ..as
based on information concerning the mode of action of methoprene
and the chemical structure of methoprene compared to its naturally
occurring counterpart. Methoprene is an insect growth regulator
and exhibits a mode of action other than direct toxicity in the
target pest. Also, the chemical structure of methoprene is
substantially similar to natural juvenile insect hormone. Eotn
chemicals are long-chain esters containing only carbon, hydrogen,
and oxygen; have aliphatic ester groups; and similar molecui?.r
3
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weights. The major structural difference between the two chemicals
is that the naturally occurring material has an epoxide (cyclic
ether) ring while in methoprene this ring is converted to an open-
chain methyl ether.
The Errata Sheet for methoprene eliminated environmental fate
data requirements listed in the 1982 Registration Standard since
they were no longer applicable to methoprene when classified as a
biochemical pesticide. For biochemical pesticides, environmental
fate studies comprise Tier II testing to be triggered by non-target
organism concerns. At the time of the Errata Sheet, EPA did not
believe further environmental testing was required. The following
are the environmental fate data requirements that were eliminated:
- photodegradation in air and water
- aerobic soil metabolism
- aerobic and anaerobic aquatic metabolism
- leaching/adsorption/desorption
- laboratory and field volatility
- terrestrial field and long term soil dissipation
- confined and field rotational crops
- bioaccumulation in fish
- bioaccumulation in aquatic non-target organisms
#
The "Errata Sheet still required, however, the remaining two
studies that were listed in the 1982 Registration Standard for
technical methoprene:
154-8 Fish Toxicity Study with Rainbow Trout
151-17 Octanol/Water Partition Coefficient
The ecological effects data requirement, Fish Acute LC50 in
Rainbow trout (154-8), was satisfied at the time the Errata Sheet
was issued in 1982 with MRID 00010643. Therefore this requirement
no longer constitutes a data gap and was listed as satisfied in the
Errata Sheet.
Product chemistry, acute toxicity and efficacy data on the
formulated end use products that were listed in the 1982
Registration Standard were also still required in the Errata Sheet.
However, the-Errata Sheet stated that the Table C toxicological
data requirement for primary eye irritation (152-13) for granular
and pelleted tablet methoprene products was no longer needed. The
Agency's rationale for originally requesting these data was the
possibility of exposure to the dust of these granular products.
Subsequently, information on the particle size of all of the
currently registered granular methoprene products has beer,
submitted to the Agency. The data showed that most of the
particles exceed 150 microns in size and are too heavy to
constitute a dust. Therefore, the Agency determined that this
requirement was no longer needed.
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III. AGENCY ASSESSMENT
A. -PRODUCT IDENTIFICATION
Technical Methoprene is a pale yellow liquid with a faint
fruity odor and has a boiling point of 100°C at 0.05 mm of Hg.
Samples of methoprene stored in glass for 4 years at 70°F did not
show any appreciable chemical decomposition. Technical Methoprene
is soluble in water at 1.39 ppm and very soluble in all common
organic solvents. The specific gravity of technical methoprene is
0.9261 at 20°C. Technical Methoprene is intended only for re-
formulation into an end-use pesticide and, therefore, is considered
a "manufacturing-use" product.
The 1982 Registration Standard as modified by the Errata Sheet
for Methoprene required additional product chemistry data for the
Octanol/Water Partition Coefficient. Although this requirement is
not critical to the reregistration decision or environmental
assessment of methoprene at this time, the Agency is requiring thi^
data to satisfy the gap in the product chemistry data base for this
chemical. ""
#
B. HUMAN HEALTH ASSESSMENT
1. Toxicology Data Base
All current toxicological data requirements are satisfied.
No further data were required in the 1982 Registration Standard as
modified by the Errata Sheet for technical methoprene and no
additional data have been submitted. All Tier I toxicological
studies required for Methoprene have been submitted except for the
Immunotoxicity Study (Guideline 152B-18). The required Tier I
toxicological studies submitted for methoprene include the acute
toxicity battery, a subchronic feeding study, a developmental
toxicity study, and a mutagenicity study. The immunotoxicity study
normally required for biochemical pesticides has been waived for
methoprene since subchronic, chronic, teratology, and reproduction
studies have already been submitted for methoprene and have shown
no significant adverse toxicological effects. If the immune syster.
were a sensitive target for methoprene toxicity, then this would
have been expected to result in at least some signs of toxicity in
some of the studies that comprise the extensive data base for
methoprene. The results of the review of the toxicological data
base are presented below:
a. Acute Toxicity
The acute oral LD50 value is determined to be greater thar.
10,000 mg/kg for rats and between 5,000 and 10,000 mg/kg for dcgs.
These data indicate a low acute oral toxicity potential and place
5
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technical methoprene in toxicity category IV. The acute dermal ld50
for rabbits is determined to be greater than 2000 mg/kg and the
acute inhalation LCS0 in rats is greater than 2 0 mg/1. These data
indicate a low human acute toxicity potential for methoprene and
places it in toxicity category III for acute dermal toxicity and
toxicity category IV for acute inhalation toxicity.
Sufficient data are available to assess the primary eye and
dermal irritation potential of methoprene. In an eye irritation
study, 0.1 ml of technical methoprene did not cause eye irritation
or corneal opacity in rabbit eyes. Additionally, when rabbits were
given 24 hour dermal exposure to 0.5 ml technical methoprene, on
shaved, abraded and unabraded skin, no dermal irritation was
observed for up to 72 hours. These data indicate that methoprene
is not a primary eye or dermal irritant and places it in toxicity
category IV for both eye and dermal irritation.
Several skin sensitization tests are available for technical
methoprene. A skin sensitizing test was conducted in guinea pigs.
Undiluted methoprene was administered by multiple intradermal
injection. A positive reaction was obtained. However, when the
test was subsequently repeated by topical application the results
were negative. Additionally, a test was performed according to p
standard Draize method on human subjects to determine the huroa'n
contact sensitization potential of the test chemical. No positive
responses were observed and it was determined that the test
chemical is not a human skin sensitizer under the test conditions.
b. Subchronic Toxicity
A 90-day study was conducted in rats given 0, 250, 500, 1000,
or 5000 ppm methoprene. A significant increase in liver weights
was observed in both males and females at the highest dose. Ir.
addition, kidney weights in males at 5000 ppm were significantly
increased. Renal tubular degeneration was observed in 7 out of 15
males at 5000 ppm and 3 out of 15 males at 1000 ppm. Based cn
these findings, a no observed effect level (NOEL) for systemic
toxicity was established at 500 ppm. The lowest effect level was
1000 ppm.
A 90-day study was also conducted in dogs given 0, 2 50, 5 0o,
or 5000 ppm metfhoprene. The results showed that liver weights for
males and females at 5000 ppm were significantly elevated.
addition, serum alkaline phosphatase (SAP) levels in males at 5Co:
ppm were elevated at the 4, 8, and 13 week testing intervals.
Females at this dose had elevated SAP levels at the 8 week interval
only. No other treatment related effects were observed. Based :r.
these findings the no observed effect level (NOEL) for systemic
toxicity was established at 500 ppm and the lowest effect level was
5000 ppm.
A 21-day dermal toxicity study in rabbits was conducted 2nd
6
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satisfies the requirement for subchronic dermal toxicity testing.
Five groups of five male and five female Japanese rabbits were
acclimated for 20 days and.treated with undiluted Altosid" at o,
100, 300, 900 or 2700 mg/kg/day for thirty days. The chemical was
applied topically on the back of the animal which was previously
clipped free of hair. Except for redness observed from day 4 to
29 at the application sites in the highest dose group, no treatment
related effects were observed. The NOEL is considered to be 100
mg/kg of body weight. Higher doses caused a decrease in body
weight gain.
In a 21-day inhalation study in rats, the NOEL was determined
to be 2 0 mg/1 (highest dose tested).
c. chrpnic Effect?
In a chronic feeding study, rats were fed diets containing 0,
250, 1000, or 5000 ppm methoprene (86.9% A.I.) for two years. No
treatment related effects on body weight, food consumption,
behavior, hematology, blood chemistry, urinalysis and organ weights
were observed. Eye examinations did not indicate a treatnentr
related effect. At the end of the study, survival wa»
approximately 50% in all groups. At necropsy no treatment related
gross pathological or histopathological lesions were observed. In
addition, there was no increase in tumor incidence in treated
groups. The NOEL from this study is indicated as 5000 ppm, which
is the highest dose tested.
In another study, four groups of 50 male and 50 female Charles
River CD-I mice were fed diets containing 0, 250, 1000, or 2500 per.
methoprene for 18 months. No differences were observed in the tumor
incidence between the control and treated groups. No treatment
related effects on body weight, food consumption and general
behavior were observed. At 18 months, survival was approximately
50% in all groups. At necropsy, no treatment related gross
pathological changes were observed. However, histopathological
examination indicated high incidence of brown pigmentation or
liver at 2500 ppm. This finding was also observed in some mice at
1000 ppm but was absent at the 250 ppm level and in the control
group. Amyloidosis was observed in various tissues at all dose
levels including the control group. The incidence of this finding
was approximately twice as great in the high dose test group
compared to the controls. The NOEL for systemic toxicity was
established as 250 ppm.
d. Oncogenicity
Data are available to assess the chronic toxicity anc
oncogenic potential of methoprene. In a 2-year feeding study vitn
rats, the NOEL for systemic toxicity was determined to be 5000 ppm.
(highest dose tested). No indication of an oncogenic effect wa;
7
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observed even at the highest dose level. In an 18-mcnth
oncogenicity study with mice no evidence of oncogenicity was
observed at any dose level. The NOEL for systemic toxicity was
established.as 2 50 ppm.
e. Developmental Toxicity and Reproduction
Data are available to show that methoprene is not a
developmental toxicant in rabbits at doses as high as 2000 mg/kg,
when administered on gestation days 7 through 18. Maternal
toxicity as demonstrated by a 38.4% reduction in body weight gain
and a 20% incidence of abortion and fetotoxicity was observed at
2000 mg/kg/day. Based on the doses tested, the lowest effect level
for maternal toxicity and embryolethality in utero is 2000
mg/kg/day and the NOEL is 200 mg/kg/day. A second teratogenicity
study was conducted in mice given 0, 50, 200, or 600 mg/kg/day
methoprene on days 7 through 14 of gestation. At 600 mg/kg/day
(highest dose tested), no maternal toxicity, fetotoxicity or
teratogenicity was observed. The data from this study support the
conclusion that this chemical is not a developmental toxicant iff
mice and the NOEL for developmental effects is established at 6op
rog/kg/day. *
Data are available to assess the reproductive toxicity cf
methoprene in rats. In a three generation reproduction study, the
NOEL was determined to be 2500 ppm (highest dose tested).
f. Mutagenicity
A bacterial assay and a dominant lethal study in rats
presented sufficient evidence to indicate that methoprene is net
mutagenic.
g. Metabolism
A series of studies,investigating the metabolism of methoprer.e
in the rat, mouse, guinea pig, steer and cow are available. These
studies indicate rapid and extensive biodegradation of methoprer.e
and its metabolites in mammalian species and that methoprer.e
metabolites are incorporated into natural body constituents.
8
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2. DIETARY EXPOSURE
a
Residue Data
There_were no residue chemistry data deficiencies identified
in the 1982 Registration Standard as modified by the Errata Sheet
for methoprene. The nature of the residue in plants and livestock
is adequately understood. The residue of concern is methoprene per
se. Adequate methodology is available for enforcement purposes and
an adequate data base is available to support the present tolerance
levels in the subject commodities.
Tolerances have been established in 40 CFR 180.359 for
residues of methoprene, as well as Codex MRLs (Maximum Residue
Levels) and Canadian tolerances in or on the following raw
agricultural commodities as listed below:
Commodity
40 CFR 180.359
Tolerance
(ppm)
Codex
MRLs
Canadian
Tolerance
(ppm)
Cattle, fat
Cattle, meat
Cattle, meat byproducts
Eggs
Goats, fat
Goats, meat
Goats, meat byproducts
Hogs, fat
Hogs, meat
Hogs, meat byproducts
Horses, fat
Horses, meat
Horses, meat byproducts
Milk
Mushrooms
Peanuts
Peanut hulls
Poultry, fat
Poultry, meat
Poultry, meat byproducts
Sheep, fat
Sheep, meat
Sheep, meat byproducts
Meat, fat
Cattle milk
Edible Offal (mammalian)
0.3
0.1
0.1
0. 05
0.3
0.1
0.1
0.3
0.1
0 .1
0.3
0.1
0.1
0.05
1.0
2 . 0
0.5
0.5
0.5
0.3
0.1
0.1
40. 00
0. 05
0.2
2.0
0.1
0.05
0.1
0 . 1
9
-------
The U.S. Tolerances and Codex MRL's are expressed in terms of
methoprene per se. The levels are identical for all of the
pertinent commodities with the exception of mushrooms and meat fat.
Lowering the meat fat (cattle, goat, hog, and horse fat) tolerance
of 0.3 ppm_to 0.1 ppm could result in residues of methoprene
exceeding the tolerance level in this commodity because of current
and pending feed uses. Thus the U.S. tolerance should not be
changed to match the Codex MRL at this time. The difference in the
mushroom Codex MRL and U.S. tolerance reflects differences in
types of treatments and therefore, no correlation of the two limits
could be accomplished at this time. There are no Mexican
tolerances.
The mosquito vector control uses that were exempt from the
requirement of a tolerance under 40 CFR 180.1033 and 185.4150, are
now considered non-food uses. Thus the exemptions are no longer
applicable and will be revoked.
It should be noted that there is a tolerance petition pending
(PP#4F3103) for tolerances of 5, 10, and 25 ppm on cereal grains,
grain milled fractions and rice hulls, respectively.
Methoprene as a feed additive may be safely used in accordance
with the following prescribed conditions under 40 CFR 186.4150: *
It is used as a feed additive in the form of mineral
and/or protein blocks or other feed supplements in the
feed of cattle at the rate of 22.7 to 45.4 milligrams per
100 pounds of body weight per month.
It is used to prevent the breeding of hornflies in the
manure of treated cattle.
To ensure safe use of the additive, the label and
labeling of pesticide formulations containing this
additive shall conform to the label and labeling
registered by the U.S. Environmental Protection
Agency.
-------
b. Reference Dose
The following data were considered for establishing the
Reference Dose (RfD) for methoprene:
Study Species
Chronic Toxicity/Oncogenicity (18 months) mice
The reference dose for chronic oral exposure was determined
based upon an LEL for liver pigmentation at 150 mg/kg/day (loco
ppm) and a NOEL of 37.5 mg/kg/day (250 ppm) in the 18-month r.ouse
feeding/carcinogenicity study. An uncertainty factor of 100 vas
used to account for inter- and intraspecies differences. The RfD
therefore is 0.4 mg/kg/day.
The Agency determined the percent RfD utilized based upon
current tolerances established for residues of methoprer.e.
Approximately 0.29% of the RfD has been utilized considering the
average American food consumption. None of the subgroups of
Americans (e.g. infants, children) which are generally included in
dietary risk assessments, have dietary intake of methoprene whicti
exceeds the RfD.
c. Tolerance Reassessment
The data submitted have been determined to adequately support
the existing tolerances established for methoprene as listed in
Section III.B.2a of this document. The established tolerances are
set at the appropriate levels and no new tolerances are required
to cover the existing uses for the registered product. Exemptions
for methoprene from use as a mosquito control vector have beer,
determined to be unnecessary and will be revoked.
3. NON-DIETARY (OCCUPATIONAL) EXPOSURE
Methoprene does not meet the Agency's toxicity criteria for
requirement of re-entry or mixer/loader/applicator exposure
monitoring data because methoprene is in Toxicity Categories III
and IV for acut$ dermal and inhalation toxicity, respectively, and
there is no evidence of neurotoxic, oncogenic, reproductive, or
developmental adverse effects associated with this chemical.
Therefore, a quantitative risk assessment for occupational exposure
was not necessary and was not required.
11
-------
C. ENVIRONMENTAL ASSESSMENT
All environmental fate data requirements are satisfied. No
further data were required in the 1982 Registration Standard as
modified by the Errata Sheet for methoprene and no additional data
have been submitted.
The 1982 Registration Standard as modified by the Errata Sheet
for methoprene required one ecological effects data requirement,
a Fish Toxicity study with rainbow trout (154-8). The study has
been submitted and found acceptable.
The Agency has data to support the conclusion that most uses
of methoprene will not result in unreasonable adverse effects to
the environment. The Agency does have data, however, that shew
that methoprene is highly acutely toxic to estuarine invertebrates.
The Agency also has some data indicating reproductive effects in
these species, but there is no data on the effects of low
concentrations over the full life cycle of an estuarir.e
invertebrate species. The use of methoprene in a briquette
formulation for application in estuarine areas raises a potentiaf
concern because the briquette is designed for slow release of
methoprene -into, the water in order to control mosquito larvae.
Thus, this one use of methoprene may result in significant exposure
to estuarine invertebrates over an extended period of their life
cycle. However, there are several mitigating factors that lead the
Agency to the conclusion that methoprene could be reregistered at
this time. Most of the uses for methoprene do not involve
significant exposure to estuarine invertebrates. Only the
briquette formulation raises a concern. The other aquatic uses are
not expected to result in significant exposure because methoprer.e
is short lived in the aquatic environment and does not have a high
potential for bioaccumulation. (Methoprene dissipates rapidly in
water. Over 90% dissipates within 3 days after treatment.
Methoprene also dissipates rapidly in soil from submerged fields
remaining at 0.002 ppm which is 1% of the initial concentration in
the top 2 inches of soil 7 days after treatment). Therefore,
although most uses of methoprene will not result in significant
exposure to estuarine invertebrates, an estuarine invertebrate life
cycle toxicity study (Guideline 154-13) is needed in order tc
confirm whether or not the estimated exposure from the briquette-
formulation is "Sufficient to pose an adverse effect on estuarine
invertebrates.
1. ENVIRONMENTAL FATE DATA
Methoprene does not appear to be susceptible to hydrolysis
under normal environmental conditions. It rapidly photodegrades
in/on both aqueous and inert surfaces. In aqueous solutions
exposed to natural sunlight, complete degradation occurs within
days resulting in the formation of at least 50 minor photolysLS
12
-------
products. Photoisomerization of biologically active trans-2-
methoprene to biologically inactive cis-2-methoprene rapidly yields
an equimolar ratio of the two isomers. Other photoproducts
includedmethoxycitronellic acid, (2E) -4 , 5-epoxy-ll-methoxy-3 ,7,11-
trimethyl-2-dodecenoate, and 8-methoxy-4,8-dimethyl-2-nonanone.
Methoprene is also rapidly photodegraded on inert surfaces, forming
methoxycitronellal.
Methoprene is rapidly metabolized in soil under both aerobic
and anaerobic conditions (half-life 10-14 days). The major product
is C02.
Degradation in the aquatic environment is due to both
microbial metabolism and photolysis. Methoprene is rapidly
degraded in both sterile and nonsterile pond water exposed to
sunlight (> 80% of applied methoprene is degraded within 13 days).
The major microbial product is 7-methoxy-3,7-dimethyloctanoic acid
(methoxycitronellic acid). Degradation is somewhat less rapid
under sterile conditions than under nonsterile conditions
indicating that, although photolysis may be the main degradation
route, microbial metabolism contributes to methoprene degradation.
Methoprene degradation occurs at approximately the same ra%e
in both freshwater and saltwater maintained in the dark.
Degradation proceeds more rapidly at 20 degrees Celsius than at 4 . 5
degrees Celsius, with associated half-lives of 10-35 days and> 3 5
days, respectively. Methoprene does not leach in soil and,
combined with rapid microbial metabolism in soil, should net
persist in soil or contaminate ground water. Similarly, methoprene
dissipates rapidly from aquatic ecosystems, with over 90% of the
initial methoprene, applied as emulsifiable concentrates cr
flowable concentrates, being dissipated from a variety of aquatic
sites within 3 days of application. Uncharacterized methoprene
residues accumulate in edible tissues of bluegill sunfish and
crayfish at maximum bioconcentration factors of 457 and 75,
respectively. Their rates of depuration are unknown.
2. ^ECOLOGICAL EFFECTS DATA
a. Effects on Birds
Methoprene was found to be practically non-toxic to maliar-
ducks with an acute oral LD50 value >2000 mg/kg and an 8-day dietary
LC50 value for methoprene in bobwhite quails was found to be >10,0 30
ppm. Methoprene had no effects on quail reproduction at dietary
concentrations of 30 ppm. Dietary concentrations of 30 ppm caused
some reproductive impairment in mallard ducks, but concentrat::n:
of 3 ppm had no effect.
13
-------
b. Effects on Fish
Methoprene" is moderately toxic to warm water, freshwater fish.
The 9 6-hour LCS0 to bluegill sunfish was found to be 1.52 ppm.
Under laboratory conditions, the edible portions of bluegill
sunfish accumulated 550 and 950 times the ambient water
concentrations of 0.005 and 0.31 ppm before reaching a plateau.
Non-edible portions of the fish contained residue levels 12 times
and 4 times greater than edible portions in the low and high
concentrations, respectively. Almost 90% of the residue was found
to be unmetabolized methoprene and fish removed from exposure
excreted 93-95% of the residue within 14 days. Under simulated
natural conditions, bluegills accumulated substantial amounts of
the radiolabel, but only 4-5% of the total uC-residue was found to
be methoprene or its metabolites.
In the 1982 Methoprene Registration Standard, a Fish Toxicity
study with rainbow trout (Guideline No. 154-8) was required. The
96-hour LC50 to rainbow trout was found to be greater than 50 ppra.
Methoprene is slightly toxic to coldwater, freshwater fish.
c. Effects on Aquatic Invertebrates
#
Methoprene can be characterized as very highly toxic to
freshwater invertebrates. The 48-hour EC50 of technical methoprene
to Daphnia magna was 89 ppb and the 42-day maximum acceptable
tolerance limit was calculated to be between 27 and 51 ppb.
Crayfish exposed to aged radiolabeled methoprene residues shewed
some tendency to accumulate the radiolabeled material to about 66
times the ambient water concentration, and to levels equal to the
ambient soil concentration.
d. Effects on Estuarine and Marine Organisms
Technical methoprene is slightly toxic to very highly toxic
on an acute basis to estuarine and marine invertebrates.
Methoprene is slightly toxic to adult grass shrimp, very highly
toxic to juvenile grass shrimp, and very highly toxic to larval
mud-crabs. Technical methoprene may cause inhibition cf
gametogenesis in mud-crabs exposed to 1.3 ppm for 12-15 days.
Marine organisms are not likely to be exposed to methoprene, but
estuarine organisms are likely to be exposed. The hazards to
estuarine invertebrates as a result of the use of methoprene as a
mosquito larvicide are expected to vary depending upon the
methoprene formulation used. (The long term exposure resulting
from the slow release briquette formulation is of concern to the
Agency).
An Estuarine Invertebrate Life Cycle Toxicity Study
fMvsidopsis bahia) (154-13) is required to adequately characterize
the chronic toxicity of methoprene to estuarine crustaceans.
Methoprene is registered for direct application to salt and ticai
14
-------
marshes, including a slow release briquette formulation which could
result in longer term exposure of estuarine invertebrates. Because
methoprene is-an insect hormone that acts as an insect growth
regulator there is a concern that important nontarget species
may be adversely affected by chronic exposure to methoprene.
Existing data are on the larval stage of the mud crab but no
information is available on the entire life cycle. Because
methoprene is highly toxic on an acute basis and is expected to be
persistent in estuarine ecosystems as a result of the use of the
briquette formulation (because of its slow release action over an
extended period of time), the chronic toxicity test
is required to fully assess this long term exposure.
-------
IV. REREGISTRATION DECISION FOR ACTIVE INGREDIENT
A. DETERMINATION OF ELIGIBILITY
Section 4 (g) (2) (A) of FIFRA calls for the Agency to
determine, after submission of relevant data concerning an active
ingredient, whether products containing the active ingredient are
eligible for reregistration. The Agency has previously identified
and required the submission of the generic (i.e., active ingredient
specific) data required to support reregistration of products
containing methoprene as an active ingredient. The Agency has
completed its review of these generic data, and has determined that
the data are sufficient to support reregistration of products
containing methoprene. Appendix A identifies the generic data
requirements that the Agency reviewed as part of its determination
of reregistration eligibility of methoprene, and lists the
submitted studies that the Agency found acceptable.
The data identified in Appendix A are sufficient to allow the
Agency to conduct a reasonable risk assessment for most registered-
uses of methoprene. The data the Agency has supports the.
conclusion -.that most uses of methoprene will not result in
unreasonable' adverse effects to the environment. As mentionefl
previously, the only use of concern at this time is the briquette
formulation. The Agency therefore finds that all products
containing methoprene as an active ingredient are eligible for
reregistration except the briquette formulation which will he
considered for reregistration once the data requested in this
document is submitted, reviewed, and determined to cause r.c
unreasonable risk to nontarget organisms, specifically estuarir.e
invertebrates. Additional data are needed to fulfill the
octanol/water partition coefficient data requirement, and data are
needed to confirm whether or not the estimated long term exposure
from the briquette formulations is sufficient to pose an adverse
effect on estuarine invertebrates. The reregistration of
particular products is addressed in Section V of this document
("Product Reregistration").
The Agency made its reregistration eligibility determination
based upon the target data base required for reregistration, the
current guidelines for conducting acceptable studies to generate
such data, and the data identified in Appendix A. Although the
Agency has found that products containing methoprene are eligible
for reregistration, it should be understood that the Agency ray
take appropriate regulatory action, and/or require the submission
of additional data to support reregistration of products containmq
methoprene, if new information comes to the Agency's attention or
if the data requirements for registration (or the guidelines fcr
generating such data) change.
16
-------
B. ADDITIONAL GENERIC DATA REQUIREMENTS
The generic data base supporting the reregistration of
products containing methoprene has been evaluated and the Agency
has found that the following two additional studies are required
to support reregistration of Methoprene:
151-17 Physical and Chemical Properties - Octanol/Water
Partition Coefficient
154-13 Estuarine Invertebrate Life Cycle Toxicity Study
The Invertebrate Toxicity study is required to confirm whether
or not the estimated exposure from briquette formulation is
sufficient to pose an adverse effect on estuarine invertebrates.
C. LABELING REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING METHOPRENE
1. The labels and labeling of all products must comply witjj
EPA's current regulations and requirements. Follow the
instructions in the Product Reregistration Handbook witTi
respect to labels and labeling. >
2. Based on the reviews of the generic data, the following
additional label statements are required:
a. In the directions for use, the following statement
must appear:
"Formulators using this product are responsible f:r
obtaining EPA registration of their formulated
products."
b. In the directions for use, the following statement
regarding acceptable use patterns must appear:
"For formulation into end-use products intended only
for (list acceptable sites).
c. _In the Environmental Hazards section the following
"statment must appear:
"Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans or
public waters unless this product is specifically
identified and addressed in an NPDES permit. Cc
not discharge effluent containing this product to
sewer systems without previously notifying the
sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office
of the EPA."
17
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V. PRODUCT REREGISTRATION
A. DETERMINATION OF ELIGIBILITY
Based on the reviews of the generic data for the
active ingredient, methoprene, the products containing
this active ingredient except the briquette
formulation(s) are eligible for reregistration. Section
4(g)(2)(B) of FIFRA calls for the Agency to obtain any
needed product-specific data regarding the pesticide
after a determination of eligibility has been made. The
Agency will review these data and determine whether to
reregister individual products.
B. PRODUCT SPECIFIC DATA REQUIREMENTS
The product-specific data requirements are stated
in the attached Data Call-in appendices.
C. LABELING REQUIREMENTS FOR END-USE PRODUCTS CONTAINING
METHOPRENE
1. The labels and labeling of all products must comply
with EPA's current regulations and requirements.
Follow the instructions in the Product
Reregistration Handbook with respect to labels and
labeling.
2. Based on the reviews of the generic data the
following additional label statement is required:
"This product is toxic to aquatic invertebrates.
Using it in a manner other than that described by
the label could result in harm to aquatic
invertebrates. Do not contaminate water when
disposing of rinsate or equipment washwaters."
13
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APPENDIX A
Generic Data Reuqirements for Reregistration
of Methoprene and Data Citations
Supporting Reregistration
19
-------
GUIDE TO APPENDIX A
Appendix A- contains listings of data requirements which
support the reregistration for the pesticide covered by this
Reregistration Eligibility Document.
Appendix A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
The data table are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158. The
reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Port Royal Road, Springfield, VA 22161.
2. Use Pattern (Column 2). This column indicates the use-
patterns to which the data requirement applies. The following-
letter designations are used for the given use patterns:
A
Terrestrial food
B
Terrestrial feed
C
Terrestrial non-food
D
Aquatic food
E
Aquatic non-food outdoor
F
Aquatic non-food industrial
G
Aquatic non-food residential
H
Greenhouse food
I
Greenhouse non-food crop
J
Forestry
K
Residential
L
Indoor food
M
Indoor non-food
N
Indoor medical
0
Indoor residential
Any other designations will be defined in a footnote to the
table.
3. Bibliographic citation (Column 3). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
20
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GUIDELINE
CITATION
APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF METHOPRENE
AND DATA CITATIONS SUPPORTING REREGISTRATION
TITLE OF
STUDY
»
USE PATTERNS
BIBLIOGRAPHIC
CITATION
Product Chemistry
151-10
Identification
ABCDEFGKLMNO
151-17
151-17
151-17
151-17
151-17
Color
Odor
Solubility
Stability
Physical State
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
Data were obtained from the
most recent confidential
statement of formula
submitted.
00010927
00010927
00010925
00010927
00010927
21
« t .
-------
APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF METHOPRENE
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
TITLE OF
STUDY
U8E PATTERNS
BIBLIOGRAPHIC
CITATION
-r
Product Chemistry:
(continued)
151-17
151-17
151-17
151-17
Density or Specific
Gravity
Boiling Point
Vapor Pressure
PH
ABCDEFGKLMNO 00010927
ABCDEFGKLMNO
ABCDEFGKLMNO
00010927
00010927
ABCDEFGKLMNO 00010927
22
-------
APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF METHOPRENE
AND DATA CITATIONS SUPPORTING REREGI8TRATI0N
GUIDELINE
CITATION
Toxicology;
152-10
152-11
152-19
152-20
1 'j 2 - 2 3
152-26
152-29
S152-001
S152-002
S152-003
TITLE OF
STUDY
l
USE PATTERNS
BIBLIOGRAPHIC
CITATION
Acute Oral Toxicity
Acute Dermal Toxicity
Mutagenicity
Subchronic Oral Toxicity
Teratogenicity
Chronic Feeding
Oncogenicity
Subchronic 21-day
Dermal Toxicity
Reproduction
Metabolism
ABCDEFpKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABDLMNO
ABDLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
00024607
00010914
05018270, 00010545
00024612
00029250
00010739
00010739, 00010600
GS0030-0011
00010571
00010866, 05007755, 00010425
00010424, 00010379, 00010380
00011491, 00010879, 05008609
00010681, 00010626, 00010683
2 3
~ » .
-------
APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF METHOPRENE
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
TITLE OF
STUDY
USE PATTERNS
Residue Chemistry: '
153-3 Metabolism in Plants
153-3
153-3
153-3
Analytical Methods
Residue Data: Crops
ABDKL
Metabolism in Animals ABDL
ABDKL
ABDK
BIBLIOGRAPHIC
CITATION
05007756,
00010422,
00011031,
00010369,
00010366, 05008622
00012761,
00010867,
00011099
00010682,
00011098,
00010875
00010368
00010684
00010692
00011105, 00010687, 00010796,
00010938, 00011490, 00026940,
00010797
00010827, 00010374, 00012782
00011493, 00010374, 00012782
00012787, 00012796, 00029673,
05007751
153-3
Residue Data: Meat
and Milk
ABDL
00010682, 00010894, 00010898
00010832, 00010897, 00010619
00010896, 00010889, 00010895
00010680, 00012783, 00010833
00010893
24
t «
-------
APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGI8TRATION OF METHOPRENE
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
TITLE OF
STUDY
USE PATTERN8
Ecological Effects:
BIBLIOGRAPHIC
CITATION
154-6
154-7
154-8
154-9
S154-001
S154-002
S154-003
S154-004
Avian Single-Dose
Oral LD50
Avian Dietary LC50
Fish Acute LC50
Aquatic Invertebrate
Acute LC50
Avian Reproduction
Acute Toxicity to
Estuarine and Marine
Organisms
Aquatic Organism
Accumulation
Reptile and
Amphibian LC50
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFGKLMNO
00010633
00012754, 00012755
00010388, 00010643
00010856
00010634, 00010635
00010851, 00010852, 05010827
00010860, 00010859
05008611, 00010903, 00010390
00010405
25
» •
-------
APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF METHOPRENE
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
TITLE OF
STUDY
U8E PATTERNS
BIBLIOGRAPHIC
CITATION
Environmental Fate: r
155-9
S155-001
Hydrolysis ABCDEFGK
Field Dissipation DEFGK
Aquatic and
Aquatic Impact
00010439
05008625, 00011485, 00010434
00010435, 00010436, 00010437
00010438, 00011484, 00010433
00010417, 00011091, 00011092
00012729
2 6
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APPENDIX B
METHOPRENE BIBLIOGRAPHY
Citations Considered to be Part of the
Data Base Supporting Reregistration
27
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GUIDE TO APPENDIX B
CONTENT"OP BIBLIOGRAPHY. This bibliography contains citations
of all studies considered relevant by EPA in arriving at the
positions and conclusions stated elsewhere in the
Reregistration Eligibility Document. Primary sources for
studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of
past regulatory decisions. Selections from other sources
including the published literature, in those instances where
they have been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study". In the case of published materials, this
corresponds closely to an article. In the case of unpublished
materials submitted to the Agency the Agency has sought to
identify documents at a level parallel to the published
article from within the typically larger volumes in which they
were submitted. The resulting "studies" generally have a-
distinct title (or at least a single subject), can stand alon^.
for purposes of review, and can be- described with a
conventional bibliographic citation. The Agency has attempted!
also to unite basic documents and commentaries upon them,
treating them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by Master Record Identifier," or MRIQ
number. This number is unique to the citation, and should be
used at any time specific reference is required. It is not
related to the six-digit "Accession Number" which has been
used to identify volumes of submitted studies; see paragraph
4(d)(4) below for further explanation. In a few cases,
entries added to the bibliography late in the review may be
preceded by a nine-character temporary identifier. These
entries are listed after all MRID entries. This temporary
identifier number is also to be used whenever specific
reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing standard
elements followed, in the case of material submitted to EPA,
by a description of the earliest known submission.
Bibliographic conventions used reflect the standards of the
American National Standards Institute (ANSI), expanded to
provide for certain special needs.
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.
28
-------
As a last resort, the Agency has shown the first
submitter as author.
b. Document date. When the date appears as four digits with
no .question marks, the Agency took it directly from the
document. When a four-digit date is followed by a
question mark the bibliographer deduced the date from
evidence in the document. When the date appears as
(19??), the Agency was unable to determine or estimate
the date of the document.
c. Title. In some cases, it has been necessary for Agency
bibliographers to create or enhance a document title.
Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include (in
addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest knowr^
submission appears immediately following the word
"received." 1 ?
(2) Administrative number. The next element,
immediately following the word "under," is the
registration number, experimental use permit number,
petition number, or other administrative number
associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses identifies
the EPA accession number of the volume in which the
original submission of the study appears. The six-
digit accession number follows the symbol "CDL,"
Standing for "Company Data Library." This accession
number is in turn followed by an alphabetic suffix
which shows the relative position of the study
within the volume. For example, within accession
number 123456, the first study would be 123456-A;
the second, 123456-B; the 26th, 123456-Z; and the
27th, 123456-AA.
29
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OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
Chemical Name: Methoprene
00010366 Zoecon Corporation (1973) Metabolism of 14C Altosid by Alfalfa
and Rice. (Unpublished study received Jan 3, 1973 under
3G1343; CDL:093592-C)
00010368 Staiger, L.; Quistad, G.B.; Schooley, D.A. (1972) Non-Translocation
of Altosid and/or its Metabolites from Soil into Wheat.
(Unpublished study received Jan 3, 1973 under 3G1343; submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:093592-E)
00010369 Staiger, L. ; Quistad, G.B.; Schooley, D.A. (19??) Non-Uptake of
Altosid and/or its Metabolites by a Second Crop of Wheat
Plants Grown in Treated Soil. (Unpublished study received Jan
3, 1973 under 3G1343; submitted by Zoecon Corp., Palo Alto, -
Calif.; CDL:093592-F)
00010374 Meisch, M.V. (1973) Altosid SR-10: Test No. E-20-K-73. (Un- «
published study received on unknown date under 3G1343; submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:093592-0)
00010379 Chamberlain, W.F.; Hunt, L.M.; Hopkins, D.E.; et al. (19??) Ab-
sorption, Excretion, and Metabolism of ENT-70460 by a Guinea
Pig. (Unpublished study received Jan 3, 1973 under 3G1343; pre-
pared in cooperation with U.S. Agricultural Research Service,
Livestock Insects Laboratory, submitted by Zoecon Corp., Palo
Alto, Calif.; CDL:093592-U)
00010380 Chamberlain, W.F.; Hunt, L.M.; Hopkins, D.E.; et al. (1973) Ab-
sorption, Excretion, and Metabolism of ENT-70460 by a Hereford
Steer. (Unpublished study received Jan 3, 1973 under 3G1343;
prepared in cooperation with U.S. Agricultural Research Service,
Livestock Insects Laboratory, submitted by Zoecon Corp., Palo
Alto, Calif.; CDL:093592-X)
00010388 Sleight, B.H.c III (1972) Research Report Submitted to Zoecon
Corporation: Exposure of Fish to 14C-labeled Altosid
Accumulation, Distribution and Elimination of Residues. (Unpub-
lished study received Jan 3, 1973 under 3G1343; prepared in
cooperation with Bionomics, Inc., submitted by Zoecon Corp.,
Palo Alto, Calif.? 093592-BB)
00010390 Staiger, L.; Quistad, G.B.; Schooley, D.A. (19??) Bluegill Fish
Residues from Metabolism of Altosid. (Unpublished study
received Jan 3, 1973 under 3G1343; submitted by Zoecon Corp.,
Palo Alto, Calif.; CDL:093592-BF)
30
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00010405 Clibum, J.W. (1973) Effects of Altosid (Formerly ZR-515) cn Se-
lected Non-Target Organisms (Fish and Amphibians) When Used for
Control of" Aquatic Insects. (Unpublished study including letter
dated Jul 26, 1973 from J. W. Cliburn to John D. Diekman, re-
ceived Jan 22, 1976 under 20954-EX-5; prepared by Univ. of
Southern Mississippi, Southern Station, submitted by Zoecon
Corp., Palo Alto, Calif.; CDL:223689-L)
00010417 Zoecon Corporation (1972) Water Residue Data—Altosid. (Un-
published study received Dec 5, 1972 under 20954-EX-l; CDL:
127777-B)
00010422 Zoecon Corporation (19??) Biochemistry and Metabolic Studies with
Altosid in Crops. (Unpublished study received Dec 5, 1972
under 20954-EX-l; CDL:127777-1)
00010424 Cline, N.L.; Cohen, E.N.; Trudell, J.R. (1972) Distribution and
Elimination of Methoprene in Mice. (Unpublished study received
Dec 5, 1972 under 20954-EX-l; prepared by Stanford Univ., Medi-
cal Center, Dept. of Anesthesia, submitted by Zoecon Corp., falc
Alto, Calif.; CDL:127777-L)
00010425 Zoecon Corporation (19??) Characterization of Altosid Metabo- »
lites in the White Mouse. (Unpublished study received Dec 5,
1972 under 20954-EX-l; CDL:127777-M)
00010433 Steelman, D. (1972) Altosid SR-10: Test No. E-38-B-72. (Un-
published study received Dec 5, 1972 under 20954-EX-l; submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:127777-AA)
00010434 Schaefer, C.H. (1972) Altosid 4E: Test No. E-5-Del-72. (Un-
published study received Dec 5, 1972 under 20954-EX-l; submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:127777-AB)
00010435 Schaefer, C.H. (1972) Altosid 4E: Test No. E-6-Del-72. (Un-
published study received Dec 5, 1972 under 20954-EX-l; submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:127777-AC)
00010436 Schaefer, C.H. (1972) Altosid 4E: Test No. E-32-Del-72. (Un-
published study received Dec 5, 1972 under 20954-EX-l; submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:127777-AD)
00010437 Schaefer, C.H. (1972) Altosid SR-10: Test No. E-ll-B-72.
(Unpublished study received Dec 5, 1972 under 20954-EX-l; sub-
mitted by Zoecon Corp., Palo Alto, Calif.; CDL:127777-AE)
00010438 Kauffman, G. (1972) Altosid SR-10: Test No. E-8-B-72. (Un-
published study received Dec 5, 1972 under 20954-EX-l; submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:127777-AF)
31
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00010439 Schooley, D.; Creswell, K. (1972) The Hydrolytic Stability 5-14C-
Altosid. (Unpublished study received Dec 5, 1972 under
20954-EX-l; submitted by Zoecon Corp., Palo Alto, Calif.; CDL:
,127777-AG)
00010545 Johnston, C.D. (1973) ZR-515: Dominant Lethal Test in Rats. (Un-
published study received Oct 10, 1973 under 20954-EX-l; prepared
in cooperation with Woodard Research Corp., submitted by Zoecon
Corp., Palo Alto, Calif.; CDL:223415-D)
00010571 Killeen, J.C., Jr.; Rapp, W.R. (1974) A Three Generation Reproduc-
tion Study of Altosid in Rats: Project No. 73R-892. (Un-
published study received Nov 23, 1974 under 1157-41; prepared by
Bio/dynamics, Inc., submitted by Moorman Mfg. Co., Quincy, 111.;
CDL:101128-N)
00010600 Wazeter, F.X.; Goldenthal, E.I. (1975) Eighteen Month Oral Carcinogenic
Study in Mice: 322-003. (Unpublished study received Jan 22, 1976
under 20954-EX-5; prepared in cooperation with International Research
and Development Corp., submitted by Zoecon Corp., Palo Alto, Calif.;
C/L:224155-G)
00010619 Moorman Manufacturing Company (19??) Free Choice Residue Experi-
ment: Dosage Formula 1. (Unpublished study received Apr 9, T.975
under 1157-41; CDL:101109-C)
00010626 Quistad, G.B.; Staiger, L.E.; Schooley, D.A. (1974) Environmental
Degradation of the Insect Growth Regulator Methoprene. VIII. Bo-
vine Metabolism to Natural Products in Milk and Blood. (Unpub-
lished study received Nov 1, 1974 under 5H5070; submitted by
Zoecon Corp., Palo Alto, Calif.; CDL:221794-M)
00010633 Hudson, R.H. (1972) ZR-515. (Internal report series in pharmacolo-
gy unit of physiological and pharmacological studies; unpub-
lished study received Feb 8, 1977 under 20954-1; prepared by
U.S. Fish and Wildlife Service, Denver Wildlife Research Center,
Section of Pesticide-Wildlife Ecology, submitted by Zoecon
Corp., Palo Alto, Calif.; CDL:231486-G)
00010634 Fink, R.; Reno, F.E. (1973) Final Report: One-Generation Reproduc-
tion Study—Mallard Ducks: Project No. 777-109. (Unpublished
study receiyed Feb 8, 1977 under 20954-1; prepared by Hazleton
Laboratories, submitted by Zoecon Corp., Palo Alto, Calif.; CDL:
231486-J)
00010635 Fink, R.; Reno, F.E. (1973) Final Report: One-Generation Reproduc-
tion Study—Bobwhite Quail: Project No. 777-108. (Unpublished
study received Feb 8, 1977 under 20954-1; prepared by Hazleton
Laboratories, submitted by Zoecon Corp., Palo Alto, Calif.; CDL:
231486-K)
32
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00010643 Rausina, G. (1972) Report to Zoecon Corporation: Four-Day Dynamic Fish
Toxicity Study with Altosoid Technical in Rainbow Trout: IBT No.,
R2239. (Unpublished study received Feb 8, 1977 under 20954-1;
prepared by Industrial Bio-Test Laboratories, Inc., submitted by
Zoecon "Corp., Palo Alto, Calif.; CDL:231486-AB)
00010680 Zoecon Corporation (1974) Summary: Altosid Meat and Milk Residue
Study. (Unpublished study received Oct 10, 1974 under 20954-2;
CDL:028327-G)
Zoecon Corporation (1974) Cow Balance/Milk Metabolite Study with
5-14C-Altosid. (Unpublished study received Oct 10, 1974 under
20954-2; CDL:028327-H)
Chamberlain, W.F.; Hunt, L.M.; Hopkins, D.E.; et al. (1974)
Balance Study with 14C-Labeled Methoprene in a Dairy Cow.
(Unpublished study received Oct 10, 1974 under 20954-2; prepared
by U.S. Agricultural Research Service, Livestock Insects Lab-
oratory, submitted by Zoecon Corp., Palo Alto, Calif.; CDL:
028327-J)
Chamberlain, W.F.; Hunt, L.M.; Hopkins, D.E.; et al. (1974) Abs«rp-
tion, Excretion, and Metabolism of Methoprene by a Guinea Pig,
a Steer and a Cow. (Unpublished study received Oct 10, 1974?
under 20954-2; prepared by U.S. Agricultural Research Service,
Livestock Insects Laboratory, submitted by Zoecon Corp., Palo
Alto, Calif.; CDL:028327-K)
Quistad, G.B.; Staiger, L.E.; Schooley, D.A. (1974) Environmental
Degradation of the Insect Growth Regulator Methoprene: VI. Bo-
vine Metabolism to Natural Products in Milk and Blood. (Unpub-
lished study received Oct 10, 1974 under 20954-2; submitted by
Zoecon Corp., Palo Alto, Calif.; CDL:028327-L)
00010687 Miller, W.W.; Wilkins, J.S.; Dunham, L.L. (1974) Determination of Altcsid
Insect Growth Regulator in Waters, Soils, Plants and Animals by Gas
Chromatography. Updated method. (Contribution no. 22; unpublished
study received Oct 10, 1974 under 20954-2; submitted by Zoecon Corp.,
Palo Alto, Calif.; CDL:028326-B)
00010692 Zoecon Corporation (19??) Chicken Metabolism. (Unpublished study
received Oet 10, 1974 under 20954-2; prepared in cooperation
with U.S. Agricultural Research Service, Metabolism and Radia-
tion Laboratory; CDL:028327-W)
00010739 Wazeter, F.X.; Goldenthal, E.I. (1974) Two Year Oral Toxicity Study
in Rats (One Year Interim Report). (Unpublished study received
Oct 10, 1974 under 20954-2; prepared in cooperation with Inter-
national Research and Development Corp., submitted by Zoecon
Corp., Palo Alto, Calif.; CDL:028325-Q)
00010681
00010682
00010683
00010684
33
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00010796 Miller. W.W. (1973) Residue Determination of Altosid^(TM) : Insect Growth
Regulator in Cows Milk (Supercedes [sic #025). Method no. 039 dated
Apr 1, 1973. (Unpublished study received Jun 1, 1974 under 4F1514;
submitt_ed by Zoecon Corp., Palo Alto, Calif.; CDL: 094022-G)
00010797 Miller, W.W.; Wilkins, J.S. (1972) Residue Determination of Alto-
sid Insect Growth Regulator in Forage Grasses, Forage Leg-
umes, Rice Foliage, and Grains (Rice, Wheat, and Others). Me-
thod no. 009A (supercedes (sic) 009) dated Oct 30, 1972. (Un-
published study including amendment, received Jun 1, 1974 under
4F1514; submitted by Zoecon Corp., Palo Alto, Calif.; CDL:
094022-J)
00010827 Washino, R.K. (1973) Altosid SR-10: Test No. E-52-B-73. (Un-
published study received Jun 1, 1974 under 4F1514; submitted by
Zoecon Corp., Palo Alto, Calif.; CDL:094025-J)
00010832 Miller, R. (1973) Altosid Technical: Test No. E-60-P-73. (Un-
published study received Jun 1, 1974 under 4F1514; submitted by
Zoecon Corp., Palo Alto, Calif.; CDL:094025-T)
00010833 Wright, R. (1973) Altosid Technical: Test No. E-18-P-73. (Un
published study received Jun 1, 1974 under 4F1514; submitted^by
Zoecon Corp., Palo Alto, Calif.; CDL:094025-U)
00010851 Sleight, B.H., III (1972) Bioassay Report Submitted to Zoecon
Corporation: Acute Toxicity of Altosid to Atlantic Oyster
(Crassostrea virginica). (Unpublished study received Feb 8,
1977 under 20954-1; prepared in cooperation with Bionomics,
Inc., submitted by Zoecon Corp., Palo Alto, Calif.; CDL:
2 31488-D)
00010852 Sleight, B.H., III (1973) Bioassay Report Submitted to Zoecon
Corporation: Acute Toxicity of Altosid to Atlantic Oyster
(Crassotrea virginica). (Unpublished study received Feb 8,
1977 under 20954-1; prepared in cooperation with Bionomics,
Inc.; submitted by Zoecon Corp., Palo Alto, Calif.; CDL:
231488-E)
00010856 LeBlanc, G. (1975) The Chronic Toxicity of Altosid, TH-6040,
and R-20458 to Daphnia magna. (Unpublished study received Feb
8, 1977 uncter 20954-1; prepared by EG&G, Bionomics, submitted by
Zoecon Corp., Palo Alto, Calif.; CDL:231488-1)
00010859 Petrocelli, S.R1 (1975) The Acute and Subchronic Toxicity of R-2C453,
Altosid and TH-6040 to the Grass Shrimp, Palaemonetes cj a 10.
(Unpublished study received Feb 8, 1977 under 20854-1; prepared in
cooperation with Rionomics-EG&G, Inc. , submitted by Zoecon Corp. , Palo
Alto, Calif.; CDL:231488-R)
34
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00010860 Costlow, J.D., Jr. (1975) The Effect of Juvenile Hormone Mimics on
Development of the Mud-Crab, Rhithropanopeus harrissi (Gould).
(Unpublished study received Feb 8, 1977 under 20954-1; prepared
in cooperation with Duke Univ., Marine Laboratory, submitted by
Zoecon .Corp. , Palo Alto, Calif.? CDL: 231488-V)
00010866 Chasseaud, L.F.; Hawkins, D.R.; Franklin, E.R.; et al. (1974) The
Metabolic Fate of 5-14C-Isopropyl ll-methoxy-3,7,11-
trimethyldodeca-2,4-dienoate Altosid in the Rat. (Un-
published study received Jun 1, 1974 under 4F1514; prepared in
cooperation with Huntingdon Research Centre, submitted by Zoecon
Corp., Palo Alto, Calif.; CDL:094024-G)
00010867 Quistad, G.B.; Staiger, L.E.; Schooley, D.A. (1974) Cholesterol and
Bile Acids via Acetate from the Insect Juvenile Hormone Analog
Methoprene. (Unpublished study received Jun 1, 1974 under
4F1514; submitted by Zoecon Corp., Palo Alto, Calif.; CDL:
094024-L)
00010875 Zoecon Corporation (1973) Biochemical and Metabolic Studies with
Altosid in Crops. Summary of studies 094024-AF, 094024-AG,
094024-AK and 094024-AL. (Unpublished study received Jun 1,"
1974 under 4F1514; CDL:094024-AE)
#
00010879 Staiger, L.; Bergot, B.J.; Quistad, G.B.; et al. (1973?) Absence
of Altosid and Its Known Primary Metabolites from Steer
Tissues. (Unpublished study received Jun 11, 1974 under 4F1514;
submitted by Zoecon Corp., Palo Alto, Calif., CDL:0940240-AQ)
00010889 Zoecon Corporation (1976) Response to Registration Division, Office
of Pesticide Programs, U.S. Environmental Protection Agency on
Need for Free Choice Milk Residue Data. (Unpublished study in-
cluding letter dated Oct 15, 1976 from T.L. Burkoth to Don Duf-
fy, received Oct 20, 1976 under 6F1801; CDL:095992-A)
00010893 Zoecon Corporation (1974?) Introduction: Experiments to Elucidate
Altosid Tissue Residues. (Unpublished study received May 27,
1976 under 6F1801; CDL:095992-F)
00010894 Zoecon Corporation (19??) Altosid Residues in Milk. (Unpublished
study received May 27, 1976 under 6F1801; CDL:095992-G)
00010895 Zoecon Corporation (19??) Classical Meat and Milk Residue Experi-
ment. (Unpublished study received May 27, 1976 under 6F1801;
CDL:095992-K)
00010896 Kearley, E.O. (1975) Milk-Only Residue Experiments. (Unpublished
study received May 27, 1976 under 6F1801; submitted by Zoecon
Corp., Palo Alto, Calif.; CDL:095992-L)
35
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00010897 Zoecon Corporation (19??) Methoprene Milk Residue Dose Response.
(Unpublished study received May 27, 1976 under 6F1801; CDL:
095992-M)
00010898 Zoecon Corporation (19??) Demonstration of Decline of Altosid Resi-
dues in Milk upon Withdrawal. (Unpublished study received May
27, 1976 under 6F1801; CDL:095992-N)
00010903 Sleight, B.H., III (1973) Research Report Submitted to: Zoecon
Corporation: Kinetics of Altosid in an Aged Model Aquatic
Ecosystem Containing Crayfish (Procambarus clarki).
(Unpublished study received Oct 26, 1977 under 20954-1; pre-
pared in cooperation with Bionomics, Inc., submitted by Zoecon
Corp., Palo Alto, Calif.; CDL:232086-V)
00010914 Hepler, D.I.; Mills, V. ; Richards, Y. (1979) Acute Dermal Toxicity:
Altosid 5E Lot #FZ-515876: Project No. 1438-B. (Unpublished
study received Apr 12, 1979 under 20954-89; prepared by Elars
Bioresearch Laboratories, Inc., submitted by Zoecon Corp., Palo
Alto, Calif.; CDL:098204-E)
00010925 Thalheimer, P. (1979) Determination of Altosid in Activated Char-
coal Formulations. Method no. 135-0279-0QC dated Feb 8, 1979.
(Unpublished study received Mar 14, 1979 under 20954-EX-ll; sub-
mitted by Zoecon Corp., Palo Alto, Calif.; CDL:237801-1)
00010927 Zoecon Corporation (1972) Technical Bulletin: Altosid (For-
merly ZR-515). (Unpublished study received Dec 22, 1972 under
3G1343 ; CDL:094997-B)
00010938 Miller, W. W. ; Wilkins, J.S. (1973) Residue Determination of Altcsoid
Insect Growth Regulator in Poultry Eggs. Method no. 03 2 dated Jun
19, 1973. (Unpublished study including amendment, received Cct 26,
1977 under 20954-1; submitted by Zoecon Corp., Palo Alto, Calif.;
CDL:094022-J)
00011031 Zoecon Corporation (1978?) Metabolism Studies. (Unpublished study
received Apr 12, 1979 under 20954-89; CDL:098205-A)
00011091 Biedler,. E.J. (1977) Altosid Briquet: Test No. E-22-P-77. (Unpub-
lished study received Dec 6, 1977 under 20954-13; submitted by
Zoecon Core.., Palo Alto, Calif.; CDL: 232438-AC)
00011092 Biedler, J. (1977) Altosid Briquet: Test No. E-23-P-77. (Unpub-
lished study received Dec 6, 1977 under 20954-13; submitted by
Zoecon Corp., Palo Alto, Calif.; CDL:232438-AD)
36
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00011098 Zoecon Corporation (1974) Metabolism and Excretion of Altosid by
Leghorn Hens. (Unpublished study including letters dated Aug 8,
1974 from T.L. Burkoth to Kenneth L. Davison and Aug 20, 1974
from K.L. Davison to Terry L. Burkoth, received Dec 18, 1974 un-
der 20B34-EX-3; prepared in cooperation with U.S. Agricultural
Research Service, Metabolism and Radiation Research Laboratory;
CDL:127776-0)
00011099 Quistad, G.B.; Davison, K.L.; Staiger, L.A; et al. (1974) Environ-
mental Degradation of the Insect Growth Regulator Methoprene:
IX. Chicken Metabolism. (Unpublished study received Dec 18,
1974 under 20954-EX-3; prepared in cooperation with U.S. Agri-
cultural Service, Metabolism and Radiation Research Laboratory,
State Univ. Station, submitted by Zoecon Corp., Palo Alto, Ca-
lif.; CDL:127776-P)
00011105 Hunt, L.M.; Gilbert, B.N. (1975?) Micromethod for Determining In-
sect Growth Regulator Methoprene in Bovine Fat. (Unpublished
study received Sep 13, 1976 under 20954-5; prepared by U.S. Ag-
ricultural Research Service, Livestock Insects Laboratory, sub-
mitted by Zoecon Corp., Palo Alto, Calif.; CDL:095296-P)
»
00011484 Zoecon Corporation (19??) Soil Residue Data—Altosid. (Un-
published study received Dec 5, 1972 under 20954-EX-l; CDL:
127777-H)
00011485 Steelman, D. (1972) Altosid: 4E, R-20458 4E, and Monsanto 585:
Test No. E-129-B-72. (Unpublished study received Dec 5, 1972
under 20954-EX-l; submitted by Zoecon Corp., Palo Alto, Calif;
CDL:127777-Y)
00011490 Zoecon Corporation (19??) Validation Data Altosid. (Unpublished
study received Jun 1, 1974 under 4F1514; CDL:094022-K)
00011491 Zoecon Corporation (1973?) Metabolism of 14C-Altosid in the Steer.
(Unpublished study received Jun 1, 1974 under 4F1514; CDL:
094024-AP)
00011493 Zoecon Corporation (1973) Residue Analytical Data for Rice. Sum-
mary of studies 232087-M through 232087-0. (Unpublished study
received Oct 26, 1977 under 20954-1; CDL:232087-L)
00012729 Hazeltine, B. (1972) Altosid SR-10 Test No. E-10-B-72. (Un-
published study received Dec 5, 1972 under 20954-EX-l; submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:127777-Z)
00012754 Fink, R. (1972) Final Report: Eight-Day Dietary LC50—Mallard
Ducks: Project No. 777-100. (Unpublished study received Feb 3,
1977 under 20954-1; prepared by Hazleton Laboratories, submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:231486-H)
37
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00012755 Fink, R. (1972) Final Report: Eight-Day Dietary LC50—Bobwhite
Quail: Project No. 777-101. (Unpublished study received Feb 8,
1977 under-20954-1; prepared by Hazleton Laboratories, submitted
by Zoecon Corp., Palo Alto, Calif.; CDL:231486-1)
00012761 Zoecon Corporation (1974) Summary: Metabolism of 14C-Altosid by
the Steer. (Unpublished study received Oct 10, 1974 under
20954-2; CDL:028327-E)
00012782 Meisch, M.V. (1973) Altosid SR-10: Test No. E-20-K-73. (Un-
published study received Jun 1, 1974 under 4F1514; submitted by
Zoecon Corp., Palo Alto, Calif.; CDL:094025-K)
00012783 Zoecon Corporation (1973?) Residue Analytical Data for Meat and
Meat By-products: Altosid Summary of studies 094025-T and
094025-U. (Unpublished study received Jun 1, 1974 under 4F1514;
CDL:094025-S)
00012787 Zoecon Corporation (1973) Residue Analytical Data for Altosid on
Fish and Shellfish. Summary of studies 232087-R through
232087-U. (Unpublished study received Oct 26, 1977 under
20954-1; CDL:232087-P)
00012796 Zoecon Corporation (1979) Residue Studies Altosid. (Unpublished
study received Apr 12, 1979 under 20954-89; prepared in coopera-
tion with Campbell Institute; CDL:098205-R)
00024607 Hallesy, D.W.; Shott, L.D.; Hill, R. (1972) Effects of a Single
Oral Dose of 10 G/Kg of ZR 515 on Rats: Report # 71-R-72-ZR 515-
PO-TX. (Unpublished study received Jan 3, 1973 under 3G1343;
prepared by Syntex Research, submitted by Zoecon Corp., Palo Al-
to, Calif.; CDL:093595-F)
00024612 Jorgenson, T.A.; Sasmore, D.P. (1972) Toxicity Studies of Alto-
sid (TM): Technical: (1) Ninety-Day Subacute in Rats, (2) Nine-
ty-Day Subacute in Dogs: SRI Project LSC-1833; Report No. 2.
(Unpublished study received Jan 3, 1973 under 3G1343; prepared
by Stanford Research Institute, submitted by Zoecon Corp., Pale
Alto, calif.; CDL:093595-M)
00026940 Miller, W.W. (1975) Residue Determination of Altosid Insect Growth
Regulator "in Animal Tissues and Blood (Poultry, Cattle, Fish, and
Shellfish). Method No. 068 dated Jan 7, 1975. (Unpublished st^dy
received Aug 11, 1976 under 20954-EX-7 submitted by Zoecon Corp., ?alo
Alto, California; CDL:227735-AH)
38
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00029250 Nakasawa, M. ; Matsumiya, H. (1978) Investigation of Altosid (R) Toxicity:
III Determination of Teratogenic Potential of Altosid Administered
Orally to Rabbit: Project No. NRI-PL-74-2465. (Unpublished study
translated from Japanese, including letter dated May 25, 1978 from
M. Nishikawa to Terry L. Burkoth, received Feb 25, 1980 under 20954-
1; prepared by Nomura Research Laboratory, submitted by Zoecon Corp.,
Palo Alto, Calif; CDL:242045-B)
00029673 Markowitz, N. ; Short, K.T.; Murphy, D. ; et al. (1979) Residue Data:
[Altosid 5E. (Unpublished study including letter dated Jan 15, 1980
from J.H. Stoner to James Young and test nos. SE IR 350A 79, wo JR
203-79, SE IR 300A-79 ... received Jan 31, 1980 under 20954-89;
prepared in cooperation with Univ. of Delaware and Stoner
Laboratories, submitted by Zoecon Corp. , Palo Alto, Calif; CDL:099410-
C)
05007751 Hunt, L.M.; Gilbert, B.N. (1976) Micromethod for Determining Insect
growth regulator methoprene in bovine fat. Journal of Agricultural
and Food Chemistry 24(3):669-670.
05007755 Hawkins, D.R.; Weston, K.T.; Chasseaud, L.F.; Franklin, E.R.
(1977) Fate of methoprene (isopropyl
(2E,4E)-ll-methoxy-3,7,ll-trimethyl-2,4-dodecadienoate) in
rats. Journal of Agricultural and Food Chemistry »
25(2):398-403.
05007756 Quistad, G.B.; Staiger, L.E.; Schooley, D.A. (1974) Environmental
degradation of the insect growth regulator methoprene (isopropyl
(2E,4E)-ll-methoxy-3,7,ll-trimethyl-2,4-dodecadienoate) I
Meta-bolism by alfalfa and rice. Journal of Agricultural and
Food Chemistry 22 (4):582-589.
05008611 Quistad, G.B.; Schooley, D.A.; Staiger, L.E.; Bergot, B.J.; Sleight,
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