RBREGISTRATION ELIGIBILITY DOCOMENT
ALUMINUM TRIi (fi-ETHYLIHOSIHONATE)
(REFERRED TO AS FOSETYIi-Al J
LIST A
DECEMBER 1990
EKVIROKMENfAL PROTECTION AGENCY
OFFICE OF PESTICIDE PR08RAHS
SPECIAL REVIEW AND RIREGISTRAtlON DIVISION
WASHINGTON, D.C.
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TABLE OF CONTENTS
PAGE
GLOSSARY OF TERMS AND ABBREVIATIONS
EXECUTIVE SUMMARY
X. INTRODUCTION 1
II. ACTIVE INGREDIENTS COVERED BY THE REREGISTRATION DECISION 2
DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT 2
B. USE PROFILE 2
C. REGULATORY HISTOBY 3
III. AGENCY ASSESSMENT OF ACTIVE INGREDIENT 3
A. PRODUCT CHEMISTRY ASSESSMENT 4
B. HUMAN HEALTH ASSESSMENT 4
1. TOXICOLOGY DATA 4
a. ACUTE TQXICITY
b. CHRONIC TOXICITY
c* ONCOGENICITY
d. DEVELOPMENTAL TOXICITY AND REPRODUCTION
e. MUTAGENICITY
f. METABOLISM
2. DIETARY EXPOSURE 8
a. RESIDUE DATA
b. REFERENCE DOSE
C. TOLERANCE REASSESSMENT
3. NON-DIETARY EXPOSURE 12
C. ENVIRONMENTAL ASSESSMENT 13
1. ENVIRONMENTAL FATE ASSESSMENT 13
2. ECOLOGICAL EFFECTS ASSESSMENT 13
ft. ECOLOGICAL EFFECTS DATA
b. ECOLOGICAL EFFECTS RISK ASSESSMENT
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TABLE Of CONTENTS
IV. REREGISTRATION DECISION TOR FOSETYL-A1 IS
A. DETERMINATION OF ELIGIBILITY 15
B. ADDITIONAL GENERIC REQUIREMENTS 16
C. LABELING REQUIREMENTS 17
V. PRODUCT REREGISTRATIQN 18
A. DETERMINATION OF ELIGIBILITY 18
B. PRODUCT-SPECIFIC DATA REQUIREMENTS 18
C. LABELING REQUIREMENTS 18
VI. APPENDICES
A. GUIDE TO APPENDICES A i B 20
B. APPENDIX A - GENERIC DATA REQUIREMENTS FOR
REREGISTRATIQN OF FOSETYL-AL AND DATA CITATIONS
SUPPORTING REREGISTRATION
1. PRODUCT CHEMISTRY 22
2. ECOLOGICAL EFFECTS 23
3. TOXICOLOGY 24
4. PLANT PROTECTION 26
5. NONTARGET INSECT-TESTING 26
6. ENVIRONMENTAL FATE 2i
7. RESIDUE CHEMISTRY 27
C. APPENDIX B - PRODUCT SPECIFIC DATA REQUIREMENTS FOR
PRODUCTS CONTAINING FOSETYL-AL AND DATA CITATIONS
SUPPORTING REREGISTRATION OF MANUFACTURING AND END-USE
PRODUCTS
FOR MANUFACTURING-USE PRODUCTS
1. PRODUCT CHEMISTRY 30
2. TOXICOI^GY 31
FOR END-USE PRODUCTS
1. PRODUCT CHIMISfRY 33
2. TOXICOLOGY 35
D. APPENDIX C - BIBLIOGRAPHY
1. GUIDE TO APPENDIX C 37
2. BIBLIOGRAPHIC CITATIONS 39
ii
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ADI
a. i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HDT
K+CWHR
LC50
LD50
LDT
LEL
MP
MPT
GLOSSARY OF TERMS AND ABBREVIATIONS
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
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 to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
Median lethal dose - a statistically derived single
dose 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 of substance per unit weight of animal, e.g.,
»g/kg.
Lowest Dose Tested
Lowest Effect Level
Manufacturing Use Product
Maximum Permissible Intake
ill
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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
ppn Parts per Million
RfD Reference Dose
RS Registration Standard
TMRC Theoretical Maximum Residue Contribution
iv
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EXECUTIVE SUMMARY
Fosetyl-Al is a fungicide registered in the United States
for use on almonds, asparagus, avocados, eaneberries, citrus,
ginseng, pome fruits, pineapples, stone fruits and ornamental
plants, lawns and turf. There are two registered products; 95%
technical product and 80% wettable powder, Products which
contain fosetyl-al as an active ingredient are eligible for
reregistration for the uses mentioned above.
A registration standard entitled, "Guidance for the
Reregistration of Pesticide Products containing aliette as the
active ingredient" (pb 84-206564), was developed in 1983 in
conjunction with the initial reregistration of the chemical. A
draft revised registration standard for fosetyl-Al was issued for
public comment in December 1986, and issued in final in February
1988. The registration standards summarized the available data
supporting the registration of fosetyl-Al and required additional
data to assure that the proper use of the pesticide poses no
potential adverse effects to human health or the environment.
Recently, the Agency conducted a thorough review of the
scientific database and all relevant information supporting the
reregistration of fosetyl-Al, including the data submitted in
response to the registration standards. The data base consists
of toxicology, residue and product chemistry, environmental fate,
ecological effects, and non-dietary exposure data (refer to
appendix a). No further generic or product-specific data are
required. The established tolerances are set at the appropriate
levels and no new tolerances are required to cover the existing
uses for the registered products.
The data are sufficient to allow the Agency to conduct a
reasonable risk assessment for all registered uses of fosetyl-Al.
The Agency has determined for all registered uses that fosetyl-Al
can be used according to label directions without resulting in
unreasonable adverse effects. Based on the data reviewed, the
agency has determined that fosetyl-Al poses no unreasonable
adverse effect to human health and the environment and declares
that^products containing fosetyl-Al as an active ingredient are
eligible for reregistration and will be reregistered when
appropriate labels are submitted.
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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
11 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 of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's
review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the
need for additional data on health and environmental
effects? and to determine whether the pesticide meets the
"no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding
the reregistration of fosetyl-Al. The document consists of
five sections. Section I is this introduction. Section II
describes fosetyl-Al, its uses and regulatory history.
Section III discusses the human health and environmental
effects assessment based on the data available to the
Agency. Section IV discusses the reregistration decision
for fosetyl-Al and Section V discusses product
reregistration. Additional details concerning the Agency's
review of available data are available on request.
EPA's reviews of specific reports and information on the
set of registered uses considered for EPA's analyses may
be obtained from the OPP Public Docket, Field Operations
Division (H7506C), Office of Pesticide Programs, EPA
Washington, D.c. 20460.
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II. ACTIVE INGREDIENTS COVERED BY THIS REREGISTRATIQN DECISION
DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT
The following active ingredient is covered by this
Reregistration Eligibility Document:
Chemical Name: Aluminum tris (o.-ethylphosphonate)
(Referred to hereafter as fosetyl-Al)
Common Name: None2
CAS Number: 39148-24-8
Office of Pesticide Programs
Chemical Code Number: 123301
Empirical Formula: A1(H6C203P}3
Trade Name: Aliette*
Pesticide Chemical Code: 123301
Case Number: 0646
Basic Manufacturer: Rhone-Poulenc
B, USE PROFILE
Type of Pesticide: Systemic fungicide
Pests Controlled: Oomyceteous fungi causing damping-
off and rot of roots, stems and
fruit.
For the purposes of this document, the name fosetyl-Al,
is used rather than Aluminum tris (o_-ethylphosphonate).
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Registered Use Sites:
Terrestrial, Foo(|
almonds (non-bearing)
asparagus
avocados (non-bearing)
caneberries
citrus (bearing and non-
bearing)
ginseng
pome fruits (non-bearing)
pineapples
stone fruits (non-bearing)
Terrestrial, Non-Food
ornamental herbaceous plants
ornamental lawns and turf
Formulation Types Registered: Technical - 95 percent
active ingredient
Formulation - 80 perc.ent
wettable powder
Methods of Application: dip treatment; pre-plant
soil incorporation?
foliar; drench
C, REGULATORS HISTORY
Fosetyl-Al was first registered by the Agency in
1983 for use on pineapples, ornamentals and turf. The
uses of fosetyl-Al for foliar application to pineapple
and to citrus were added in 1985 and 1986,
respectively. A Registration Standard was developed in
1983 in conjunction with the initial registration of
the chemical. A draft revised Registration Standard
for fosetyl-al was issued for public comment in
December 1986. No comments were received on this draft
document. This draft document was issued in final in
February 1988 and listed the following data as required
for reregistration;
171-4 Storage Stability of Residues in
Pineapples and Citrus
132-1 Foliar Dissipation
122-2 Aquatic Plant Growth
141-1 Honeybee Acute Contact LD50
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Product chemistry and acute toxicity data on the
formulated end-use product were also required to be
submitted.
Since 1988, six new uses have been registered:
avocados, asparagus, pome fruits, stone fruits, almonds
and caneberries.
III. AGENCY ASSESSMENT
The Agency has conducted a thorough review of the
scientific data base for fosetyl-Al. Based on the
evaluation of these data, the Agency has no reason to change
the major findings made in the 1988 document "Guidance for
the Reregistration of Pesticide Products Containing Fosetyl-
Al." These findings are summarized below:
A. Product Chemistry Assessment
Fosetyl-Al is a white odorless powder that rael-ts
with decomposition at temperatures greater than 200°
celsius. The solubility of fosetyl-al in water at 20°
celsius is 120 grams per liter. The chemical is stable
under normal storage conditions.
B. Human Health Assessment
1, Toxicology Data Base
All toxicology data requirements are
satisfied. No further data were required in the
1988 Guidance Document and no additional data have
been submitted. The results of the review of the
toxicology data base are presented below;
a. Acute and Subchronic Toxicitv
The LD50 from the acute oral rat study is 5.4
g/kg and the LD50 from an acute dermal rabbit study
is >2 g/kg. The LC50 for a rat inhalation study
is >1.73 mg/l. The acute oral rat and primary
dermal irritation studies indicate category IV
toxicity. A guinea pig dermal sensitization study
shows fosetyl-Al is not a skin sensitizer. The
primary eye irritation study in rabbits shows
fosetyl-Al to be an eye irritant with Category I
toxicity.
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A 21-day dermal study in rabbits showed mild
to moderate skin irritation and a No Effect Level
(NOEL) of 1.50 g/kg/day. A 90-day feeding study
in rats showed a NOEL of >5000 ppm? the Lowest
Effect Level (LEL) was 25,000 ppm with
extramedullary hematopoiesis in the spleen. A 90-
day dog feeding study showed a NOEL of 10,000 ppm
and a LEL at 50,000 ppm, at which the test animals
had a lower serum potassium level than untreated
animals.
b. Chronic Toxicity
Fosetyl-Al was fed to dogs for 2 years at
doses up to 40,000 pptn. The NOEL was 10,000 ppm,
equivalent to 250 mg/kg/day. The LEL was 20,000
ppm based on a slight degenerative effect on the
testes. These testicular changes, as well as a
few scattered clinical changes, were seen in the
high dose dogs.
c. OncogervJcity
Rat
Oncogenic effects were noted in the rat chronic
feeding/oncogenicity study. In this study,
Charles River CD rats were dosed with fosetyl-Al
at levels of 0, 2,000, 8,000, and 40,000/30,000
ppm {0, 100, 400, and 2,000/1,500 mg/kg bwt/dayj ,
The 40,000 ppm dose was reduced to 30,000 ppm
after 2 weeks following observations of staining
of the abdominal fur and red coloration of the
urine at 40,000 ppm (2,000 mg/kg bwt/day).
The highest dose level of the chemical tested
in the male Charles River CD-I rats (2,000/1,500
mg/kg bwt/day) in this study appears to be
adequate for assessing the carcinogenic potential
based on the finding of urinary bladder
hyperplasia at this dose. Similarly the dose
level appeared to be adequate in the female
Charles River CD-I rats at the high-dose level of
2,000 ng/kg bwt/day during the first 2 weeks of
the oncogenicity/chronic feeding study, before the
dose level was reduced to 1,500 mg/kg bwt/day.
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The study demonstrated a significant increase
of urinary bladder tumors (adenomas and carcinomas
combined) at the highest dose level tested
(2,000/1,500 mg/kg) in male Charles River CD-I
rats. The tumors were mainly seen in surviving
males at the time of terminal sacrifice. The
original pathological diagnosis of these tumors
was independently confirmed by another consulting
pathologist, who also reported an elevated
incidence of urinary bladder hyperplasia in high-
dose male rats. No increase of urinary bladder
tumors was observed in female rats.
Based on the diagnosis of the pathologist at
the test laboratory where the study was performed,
fosetyl-al appeared to produce a statistically
significant elevated increase of adrenal
pheochromocytomas (adenomas and carcinomas
combined) at the middle (400 mg/kg) and high
(2,000/1,500 »g/kg) dose levels in the male
Charles River CD-I rats. The elevated
pheochromocytoma increase was primarily due to an
increase in the adenomas. This diagnosis was not
confirmed by two other pathologists who
reevaluated the data. The consulting pathologists
reread the adrenal gland slides and did not find
statistically significant dose-related increases
in the incidence of pheochromocytomas for the male
rats. The Agency attributes the difference in
pathological diagnoses to the fact that a high
degree of variability exists in the interpretation
of adrenal medullary neoplasia compared to adrenal
medullary hyperplasia in identifying
pheochromocytomas. None of the three pathologists
reported a statistically significant increase in
the combined incidence of the three types of
adrenal medullary lesions (i.e., adenomas,
carcinomas, and hyperplasia).
Based on the available information, the
Agency has concluded that fosetyl-Al did not
produce a compound-related increase in adrenal
pheochromocytomas in the high-dose male rats. No
adrenal gland tumors were produced in female rats.
An oncogenicity feeding study with monosodium
phosphite, which is a metabolite of fosetyl-Al,
was conducted in rats. There was no evidence of
oncogenicity in this study.
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Mouse
In a chronic oncogenicity study in mice,
fosetyl-Al was fed at levels up to 20,000/30,000
ppm. Although this dose was extremely high and
may have approached a level that affected
nutrition, it produced no oncogenicity or other
toxic changes.
Classification of Oncogenic Potential
The Agency has concluded that the available
data provide limited evidence of the oncogenicity
of fosetyl-Al in male rats and has classified the
pesticide as a category C oncogen (possible human
carcinogen with limited evidence of
carcinogenicity in animals) in accordance with
Agency guidelines, published in the Federal
Register of September 24, 1986 (51 FR 33992). The
Agency has determined that a quantitative human
risk assessment using a low dose linear
extrapolation model is not appropriate for the
following reasons:
1. The oncogenic response observed with this
chemical was confined solely to the high dose
males at one site (urinary bladder) in rats.
2. The tumor response was primarily due to an
increase in benign tumors,
3, The tumors were seen only in surviving animals
at the time of terminal sacrifice.
4. The oncogenic effects were observed only at
unusually high doses which exceed the commonly
used limit dose of 1 g/kg/day recommended as an
upper-limiting dose for bioassays.
5. The chemical was not oncogenic when
administered in the diet to Charles River CD-I
mice at dose levels ranging from 2,500 to 30,000
ppm (357 to 4,286 mg/kg bwt/day).
6. Fosetyl-Al was not mutagenic in eight well
conducted genotoxicity assays.
The Agency concludes that data do not
demonstrate developmental or reproductive effects
of concern.
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<3. Developmental Toxicity
Rat Teratology
A teratology study in rats showed a
developmental NOEL of 1,000 ing/kg. At 4,000 rag/kg
there was maternal toxicity, as evidenced by
effects on animal weights, maternal deaths,
increased resorptions, and delayed fetal
ossification,
Rabbit Teratology
A rabbit teratology study showed no toxic
effects at oral doses up to 500 mg/kg.
Rat Reproduction
A three generation rat reproduction study had
a NOEL of 6,000 ppm. The LEL at 12,000 ppm showed
effects on animal weights in some groups and
urinary tract changes in some groups.
MUTAGENICITY
Eight mutagenicity tests performed with
fosetyl-Al were negative. The tests included two
Antes tests with S. typh iamrium, two phage
induction tests using E. coli, two mieronucleus
tests in Swiss mice and CD-I mice, one DNA repair
test using E_, coli. and one saccharomyces
cereviseae assay. Fosetyl-Al is not a routagen.
e. METABOLISM
Rat metabolism studies showed that most of
the radiolabel rapidly appeared in exhaled carbon
dioxide. There was also some radio-label excreted
in the urine as phosphite, along with a smaller
amount as the unchanged parent compound. It
appears that fosetyl-Al is essentially completely
absorbed after ingestion and extensively
hydrolyzed to carbon dioxide which is exhaled.
The phosphite is excreted in the urine without
further oxidation to phosphate.
DIETARY EXPOSURE
All residue chemistry data retirements have
been satisfied.
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a. Residue Data
Tolerances have been established in 40 CFR
180.415 for residues of fosetyl-Al in or on
the following raw agricultural commodities:
Commodity Tolerance(ppmj
Asparagus 0.13
Caneberries 0,1
Citrus 0.5
Ginseng root, fresh 0.1
Pineapple 0.1
Pineapple Fodder 0.1
Pineapple Forage 0.1
There are no Codex (international) tolerances
for fosetyl-Al. The Agency has evaluated the
residue data supporting the established
tolerances. These data are summarized below:
Metabolism Data
The metabolism of fosetyl-Al is
adequately understood. Adequate data on the
nature of the residues in both plant and
animals, including identification of major
metabolites and degradates of fosetyl-Al are
available. The major residues were fosetyl-
Al, phosphorous acid, and ethanol. The
tolerances are established for the parent
only, that is, fosetyl-Al.
There is no reasonable expectation of
residues occurring in milk and meat of
livestock and poultry, A statement on the
label prohibits the grazing of livestock in
treated citrus groves and feeding forage from
treated groves. Accordingly, tolerances in
meat, animal by products, and milk are not
necessary.
These tolerances are associated with regional
registrations as defined in 40 CFR Section 180.1 (n) .
Fosetyl-Al is registered for use on asparagus only in
California? and on ginseng in Wisconsin only.
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Radio labeled studies on the uptake,
translocation and metabolism of fosetyl-Al in
plants show that the chemical proceeds
through hydrolytic cleavage of the ethyl
ester, with phosphorous acid and most likely
ethanol as the major plant metabolites.
Analytical Methodology
There are two analytical methods
acceptable for determining the levels of
residues of fosetyl-Al in plants: a gas
chromatography method for pineapples with an
analytical sensitivity of 0.1 ppra and a
phosphorous specific flame photometric gas
chromatography method for citrus with an
analytical sensitivity of 0.02 ppm.
The only additional residue data
required in the 1988 Guidance Document were
storage stability of residues in pineapples
and citrus. These data are currently under
development but are not essential to the
reregistration decision on these commodities
for the following reasons:
1. No detectable residues of fosetyl-Al
have been observed in any of the residue
trials performed on pineapples. Some of
these trials reflected exaggerated
application rates and Pre-Harvest
Interval (PHI's) as short as 90 days.
2. Pineapples spiked with fosetyl-Al and
stored at -18°C showed a 66 to 90%
decrease of residues of this chemical
within 1 to 2 months. It is the
Agency's judgement that residues of
fosetyl-Al would decrease at even faster
rates at higher temperatures, especially
during a 90 day PHI, thus making the
possibility of observing any detectable
residues on pineapples extremely remote,
Magnitude of the Residue
There are adequate residue studies to
support the existing tolerances.
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b» Tolerance,. Reassessment
The data submitted have been evaluated
and adequately support the existing
tolerances established on fosetyl-Al as
listed in Section 2b 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.
c. Reference Dose and Dietary Risk Assessment
The following data were considered for
establishing the Reference Dose (RfD) for
fosetyl-Al:
Study Species
Chronic Toxicity (2 year) Dog
Chronic Toxicity/Oncogenicity Rat
3-Generation leproduction Rat
Teratology Rat
Teratology Rabbit
Using a 100-fold safety factor to account for
inter - and intra-species differences and the NOEL
of 250 mg/kg bwt/day determined by the 2-year dog
feeding study, the RfD is 3.0 mg/kg bwt/day
(rounded to the nearest whole number). The effect
observed in the chronic dog study was a slight
degeneration of the testes. This study is
acceptable along with all of the other studies
considered in establishing the RfD. Therefore,
the RfD is given a high confidence rating.
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The Theoretical Maximum Residue Contribution
(TMRC) from the established tolerances is
0.000274 mg/kg/bwt/day and utilizes less than i.o
percent of the RfD based on the average American
dietary intake. The dietary exposure of subgroups
(e.g., children and infants) also did not exceed
the RfD. Therefore, the dietary risK from
fosetyl-Al is very low.
Non-Dietary Exposure
Fosetyl-Al is a systemic fungicide registered
for use on several raw agricultural commodities
and ornamentals. Methods of application include
foliar application to pineapples and citrus and
thus, fieldworker exposure can be expected.
Fosetyl-Al is a severe eye irritant but does not
produce dermal irritation. In addition, fosetyl-
Al exhibits a low degree of oral, dermal, and
inhalation toxicity. Reentry data (foliar
dislodgeable residue dissipation) were required by
the 1988 Fosetyl-Al Reregistration Guidance
Document.
In support of reregistration of fosetyl-al,
the registrant submitted a foliar dislodgeable
residue dissipation study. The study was reviewed
and found to be unacceptable to fulfill the
guideline requirement. However, the Agency has
reevaluated the reentry data requirements based on
the toxicity data for fosetyl-Al. Reentry data
are required to determine the correlation between
foliar dislodgeable residue levels and dermal
exposure to fieldworkers. Since eye irritation is
the toxicological end point of concern for
fosetyl-Al and dermal exposure is not a concern,
reentry data are not required to support the
reregistration of fosetyl-Al.
Label requirements for products containing
fosetyl-Al are specified in Section IV C and V C.
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C. ENVIRONMENTAL ASSESSMENT
All environmental fate and ecological effects data
requirements have been satisfied. No further environmental
fate data were required in the 1988 Guidance Document.
Additional ecological effects data were required in the 1988
Guidance Document.
122-2 Aquatic Plant Growth
141-1 Honey Bee Acute Contact LD50
These studies have been submitted, reviewed, and
determined to be acceptable. The results are discussed
below.
1. Environmental Fate Assessment
The potential for groundwater and/or surface water
contamination by fosetyl-Al and its degradates is
expected to be very low, in most cases, due to the
rapid degradation of the compound in soil to non-toxic
degradates under both aerobic and anaerobic conditions.
Data have shown that fosetyl-Al is much more persistent
on vegetation than in soil. Therefore, when applied
foliarly to vegetation, may be available for wash off
followed by dissolved runoff to surface water for a
much longer period than might be predicted based upon
its rapid degradation in soil. In addition, due to its
high aqueous solubility, susceptibility to leaching,
and stability to abiotic hydrolysis, fosetyl-Al may
possibly leach to ground water (in porous areas with
extremely shallow unconfined aquifers or outcroppings)
in cases where an unexpected heavy rainfall closely
succeeds application.
2. Ecological Effects Assessment
a. Ecological Effects Data
In the 1988 Guidance Document, the ecological
effects data base was reviewed and determined to
be essentially complete except for two guideline
data requirements: honey bee acute contact LD50
and aquatic plant growth. These studies which are
discussed below, have been submitted, reviewed and
determined to be acceptable.
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Non-target Insects
An acute contact toxicity test with honey bees was
conducted, the LD50 for the honey bee is greater than
100 ug/bee, the highest concentration tested for
technical fosetyl-Al (95% a.i.). Fosetyl-Al is
practically non-toxic to honey bees,
Aquatic Plant Growth
Five aquatic plant growth studies were performed
with technical fosetyl-Al (95% a.i.)- The^ECgo values
for the following five species were determined to be;
SPECIES EC,D VALUE
NAVICULA PELLICULOSA 8.93 MG/L
LEMMA GIBBA 56.13 MG/L
SKELETONEMA COSTATUM 0.84 MG/L
ANABAENA FLOS-AQUAE 7.24 MG/L
gELENASTRUM CAPRI.CORNUTUM 4,99 MG/L
b. Ecological Effects Risk, Assessment
For the 1988 Guidance Document, all available
data were reviewed and no risk to non-target
species was identified from the registered uses of
fosetyl-Al.
In the intervening time from 1988 to the
present, six new uses for fosetyl-Al have been
registered: avocados, asparagus, apples and
pears, stone fruit, almonds and caneberries. No
additional testing is required for the new
registered uses. An assessment of the new uses is
presented belows
1. A review of the caneberry use indicates no
risk to non-target species.
2. Because of similar application rates and
similar uses previously approved, the use on
asparagus and avocados should not present a
risk to non-target species.
3. A risk assessment on stone fruit (apple/pear)
and almonds indicate that fosetyl-Al poses no
risk to non-endangered species,* but a concern
is raised for endangered freshwater mussels
resulting from a biological opinion about
other pesticides used on apples and pears.
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The estimated environmental concentration
from run off into adjacent ponds is 122
ppb which is larger than 1/20 (95 ppb) of the
oyster/embryo larvae EC50 of 1900 ppb.
Therefore, the endangered species level of
concern was exceeded for the apple/pear use.
The above consideration constitutes a "May
Effect" finding for the endangered mussel.
In accordance with the Memorandum of
Understanding with Fish and Wildlife Service
(FW.S), the Agency has formally consulted the
FWS regarding the reregistration of fosetyl-
Al on pome fruits, as required by Section 7
of the Endangered Species Act. As part of
this consultation, the Agency has provided
the FWS with the data and analysis upon which
the "May Effect" determination was based.
The FWS will decide whether the use of
fosetyl-Al will pose jeopardy to the
endangered mussels and, if so, what actions
the Agency must take to avoid jeopardy. At
this time, the FWS has not made a
determination on this issue. If the FWS
determines jeopardy, it also will indicate
the geographic areas in which any label
restrictions will apply. At that time, EPA's
Endangered Species Protection Program will
implement the appropriate actions needed to
protect endangered species,
Except for the endangered mussel concern, the
Agency believes that currently registered
uses of fosetyl-Al will not adversely affect
non-target species. Data required in the
1988 Guidance Document were received and
indicated no new potential risk and the
ecological effects data base is complete. No
changes in labeling will be required with the
exception of possible endangered species
restrictions.
IV. REREGISTRATION DECISION FOR FOSETXL-A1
A. DETERMINATION OF ELIGIBILITY FOR REREGISTRATION
Section 4 (g)(2)(A) of FIFRA calls for the Agency
to determine, after submission of relevant data
concerning an active ingredient, whether products
15
-------
containing the active ingredient are eligible for
reregistration. The Agency has previously identified
and required the submission of all the generic (i.e,..,
active-ingredient specific) data required to support
reregistration of products containing fosetyl-Al as an
active ingredient. The Agency has completed its review
of these generic data, and has determined that the data
are sufficient and complete to support reregistration
of products containing fosetyl-Al and support the
existing tolerances established on fosetyl-Al.
Appendix A identifies the generic data requirements
that the Agency reviewed as part of its determination
of reregistration eligibility of fosetyl-Al, and lists
the submitted studies that the Agency found acceptable.
The data identified in Appendix A were sufficient
to allow the Agency to conduct a reasonable risk
assessment for all registered uses of fosetyl-Al and to
determine for all such uses that fosetyl-Al can be used
without resulting in unreasonable adverse effects on
the environment. The Agency therefore finds^hat all
products containing fosetyl-Al as an active ingredient
are eligible for reregistration. 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 fosetyl-Al
are eligible for reregistration, it should be
understood that the Agency may take appropriate
regulatory action, and/or require the submission of
additional data to support registration of products
containing fosetyl-Al, if new information comes to the
Agency's attention or if the data requirements for
registration (or the guidelines for generating such
data) change.
B. Additional Generic Data Requirements
The generic data base supporting the
reregistration of products containing fosetyl-Al has
been reviewed and determined to be complete. No
further generic data are required to support
reregistration.
16
-------
C. labeling Requirements for Manufacturing-Use Products
Containing Fosetyl-Al
1. The labels and labeling of all products must
comply with EPA's current regulations and
requirements as outlined in the Product
Reregistration Handbook.
2. Based on the reviews of the generic data, the
following additional label statements are
required:
a. All manufacturing-use products must state
that they are intended for formulation into
end-use products for which the use pattern is
supported for reregistration.
b* In the directions for use, the following
statement must appear:
"Formulators using this product are
responsible for obtaining EPA registration of
their formulated products.11
c. In the directions for use, the following
statement regarding acceptable use patterns
must appears
"For formulation into end-use fungicide
products intended only for (list acceptable
sites)."
d. If detailed instructions for formulating are
not provided on the labelt the following
statement roust appear:
"Refer to attached Technical Bulletin for
formulating and other information."
NOTE: The technical bulletin roust be
submitted with the product label for Agency
review.
e. "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. Do not
discharge effluent containing this product to
sewer systems without previously notifying
the sewage treatment plant authority. For
17
-------
guidance contact your State Water Board or
Regional Office of the EPA."
"Pesticide Handlers: Daring mixing, loading,
or formulating of this product, wear long
pants (or coveralls), long sleeved shirt,
shoes, socks, goggles or face shield, and
chemical/water resistant gloves."
V. PRODUCT REREGISTRATIQN
A. Determination of EligibilitY
All products currently registered containing the
active ingredient fosetyl-Al are eligible for
reregistration. The Agency may require submission of
additional data before establishing any new uses.
Section 4(g)(2)(B) of FIFRA calls for the Agency to
obtain any needed product-specific data regarding the
pesticide by use after a determination of eligibility
has been made. No such data is needed at this time,
The Agency has previously identified and required
the subaittal of all product-specific data required to
support the reregistration of products containing
fosetyl-Al as an active ingredient. The Agency has
completed its review of the product-specific data and
has determined that the data are sufficient to support
the reregistration of the one currently registered
product containing fosetyl-Al.
B. Product Specific Data Requirements
There are no additional product-specific data
required.
C. Labeling Requirements., for End-Use Products Containing
Fosetyl-Al
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 statements are
required.
a, "Do not apply directly to water, swamps,
bogs, marshes, and potholes. Do not
18
-------
contaminate water when disposing of rinsate
or equipment washwaters.11
b. "Do not enter into treated areas for 24 hours
after application. During early reentry into
treated areas to perform hand labor tasks,
wear long pants (or coveralls), long-sleeved
shirt, shoes, socksr chemical/water resistent
gloves,' goggles or face shield."
3, End-use products labelled for use on citrus are to
bear the following statements
"Do not graze livestock in treated citrus
groves. Do not feed forage from treated
groves."
Labels of currently registered products must be
amended to include this statement and must be
submitted within 8 months of issuance of this
document as described in the Product
Reregistration Handbook.
19
-------
GUIDE TO APPENDICES A AND B
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 formatj
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CPR 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 Hoad, 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
K Indoor medical
O Indoor residential
Any otner 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 MHID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
20
-------
APPENDIX A
Generic Data Requirements for Reregistration
of Fosetyl-Al and Data Citations
Supporting Reregistration
21
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APPENDIX C
BIBLIOGRAPHY
36
-------
GUIDE TO APPENDIX C
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by IPA in
arriving at the positions and conclusions stated elsewhere
in the Seregistration 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,
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study". In the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the Agency the Agency has
sought to identify documents at a level parallel to the
published article from within the typically larger volumes
in which they were submitted. The resulting "studies"
generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be
described with a conventional bibliographic citation. The
Agency has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by Master Record Identifier," or MRID
number. This number is unique to the citation, and should
be used at any time specific reference is required. It is
not related to the six-digit ''Accession Number" which has
been used to identify volumes of submitted studies,* see
paragraph 4(d)(4) below for 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.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as
author. As a last resort, the Agency has shown the
first submitter as author.
37
-------
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 known
submission appears immediately following the word
"received."
(2) Administrative number. The next element,
immediately following the word "under," is^the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A? the second, 123456-
&', the 26th, 123456-Z,' and the 27th, 123456-AA.
38
-------
00098325 Rhone-Poulenc Chemical Company (1981) Product Chemistry:
[Fosetyl- all. Includes method LS 74.783 dated
Jul 7, 1980, method dated May 7, 1981 and undated
method RE-ie-81. (compilation| unpublished study
received Apr 5, 1982 under 3f9-70i? CDLJ2471S9-A)
00098326 Bertrand, A, (1981) Fosetyl-ali Composition of the
Technical Grade Industrial Product (Analysis of S
Typical latches)* Refs AG/CRLD/An Al/SV Ii4.
Includes method P-286-06-80 and method
P.306.03.81, (Unpublished study received Apr S, 1982
under 359-705; prepared by Ihone-Poulenc Agrochimie,
France, submitted by Rhone-Paulenc Chemical Co.,
Monmouth, Junction, N.J.; CDL:247159-B)
00098327 Rhone Poulenc-Agrochimie (1980} Fosetyl-al ex ca
(O-ethyl Phosphonate Salts of Aluminium or Calcium)
Lodometric Determination in the Technical Compounds
and Formulations. Method P-286-06-80 dated Jul 17,
1980. (Translation? unpublished study received
Apr S, 1982 under 359-705; submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDLJ247159-C)
00058328 Rhone-Poulenc Agrochimie (19??) Fosetyl-al Technical
Stability to Heat, Inflammability Ixplosivityt
AG/RD/DARGOIRE SRPH JD/NC/177. (Unpublished study
received Apr S, 1982 under 359-705j submitted
by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.f CDLJ247159-D)
00098330 Pasguet, J.; Mazuret, A.; Maratrat, 7; et al. (1977) LS
74-783 (Aluminium Ithyl Phosphite; 32 S4i R.P.,
Aluminium Salt): Acute Toxicity in the Rat and
Rabbit: R.P./R.D./C.N.S. No. 19 143-E. (Translation?
unpublished study received Apr S, 1982 under 359-705;
prepared by Rhone-Poulenc, France, submitted by
Rhone-Poulenc chemical Co., Monmouth Junction, N.J.;
CDLS247160-B)
39
-------
00098331 Pasguet, J.J Mazuret, A.I Kalifat, R. f et al. (1981)
Fosetyl-al (32 545 R.F., Aluminium Salt)! Acute
Percutaneous foxicity in the Rabbit: Reference C.R.
vitry/C.K.S. Ho. 21 162-E. (Translation; unpublished
study received Apr 5, 1982 under 359-705; prepared by
Rhone-Poulenc industries, France, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.;
CDL:247160-C)
00098332 Coombs, D.W.I Clarle, 6.C. (1977) Acute Inhalation
Toxicity in Ratss Four Hour Exposure to the Dust of
LS 74.783 (Technical): RHP 79/77546. (Unpublished
study received Apr S, 1982 under 359-705j prepared by
Huntingdon Research centre, England, submitted by
mhone-Poulenc Chemical Co., Monmouth Junction, N.J.;
CDLJ247160-D)
00098333 Pasquet, J.; Mazuret, A.; Maratrat, ?; et al. (1981)
Fosetyl-al (32 54S R.P., Aluminium Salt)J Primary Eye
irritation in the Rabbits Reference C.R, Vitry/C.N.G.
Ho. 21 163-B. (Translation; unpublished study .
received Apr 5, 1982 under 319-705; prepared
by Rhone-Poulenc Industries, France, submitted by
Rhone-Pouleno Chemical Co., Monmouth Junction, N.J.;
CDLS247160-E)
00098334 Pasquet, J.; Mazuret, A.j Maratrat, fl et al. (1981)
Fosetyl-al (32 545 R.P., Aluminium Salt): Primary
SJcin Irritation in the Rabbits Reference C.R.
vitry/C.N.G. Ho. 21 164-E. (Translation; Unpublished
study received Apr 5, 1982 under 359-705; prepared
by Rhone-Poulenc Industries, France, submitted by
Rhone-Potilenc Chemical Co., Monmouth Junction, H.J.?
CDL:247160-F)
00098335 Elliott, P.H.; Beaber, J.A. (1979) Screening Test for
Delayed Contact Hypersensitivity with Efosite-al (LS
74_783) in the Albino Guinea Pig: 79443D/RNP/168.
(Unpublished study received Apr i, 1982 under
359-705; prepared by Huntingdon Research Centre,
England, submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.? CDL:247160-S)
00098336 Coquet, B.; Guyot, D.; Galland, L.; et al. (1977) LS
74783! 3 Month Oral Toxicity study in the Rats IFR1B
R 770359. (Translation; unpublished study received
Apr 5, 1982 under 359-705; prepared by Institute
Francais de Recherches et Essais Biologigues,
France, submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, K.J.? CDLS247161-A)
40
-------
000§8337 Coquet, B.I Glair, M. (1977) LS 74783 {aluminium
Ethylphosphite) s 3 Month oral Toxicity Study in the
Dogs 1FREB-R 712110. A translation of: LS 74783
(Ithylphosphite D1Aluminium)! Toxicite a Terme (3
Mois) par Voie Orale Chez le Chiem IPREB-R 709235.
(Unpublished study received Apr I, 1982 under
359-705? prepared by Institut Franeais de Reeherehes
et Issais Biologicpies, France, submitted by
Rhone-Poulenc chemical Co., Monmouth Emotion, H.J.?
CDLJ247161-B)
00098331 Kynoch, S.R.t Lloyd, G.K.i Mallard, J.R.? et al, (1979)
The Effect of Repeated Applications of LS 74783
Technical to the Skin of Rabbits for Twenty-one Days:
RHP/123/79314. (Unpublished study received Apr 5,
1982 under 319-705? prepared by Huntingdon
Research Centre, England, submitted by Rhone-Poulene
Chemical Co., Monmouth, H.J.? CDL:247161-C)
00098339 Spicer, E.J.F.? Trumbull, R.R.? Blanchard, G.L.? et al.
(1981) Chronic Toxicity (2 Year) and Carcinogenicity
Study in Ratss 347-016. (Unpublished study received
Apr S, 1982 under 359-705? prepared by international
Research and Development Corp., submitted by
Rhone-Poulenc chemical Co., Monmouth Junction, H.J.j
CDLt247162~A? 247164; 247165? 247166)
0009S340 Spicer, B.J.F.i Phillips, L.M.,' Richter, w.R.f at al.
(1981) Two-year Dietary Toxicity Study in Dogs! IRDC
Study No* 347-023. (Unpublished study received Apr 5,
1982 under 359-705| prepared by international
Research and Development Corp., submitted by
Rhone-Poulenc Chemical Co,, Konmouth Junction, K.J.?
CDLS247167-A)
00098343 Bouanchaud, D.H.I Cartier, J.R.»* Vessieres, ? (1981)
Fosetyl-al (32 S4S R.P., Aluminum Salt)s
Supplementary studies of Mutagenesis in
Microorganisms! C.R. Vitry/C.N.G. M'os 21 212.
(Unpublished study received Apr 5, 1982 under
359-705? prepared by Rhone-Poulenc industries,
Prance, submitted by Hhone-Foulenc Chemical Co.,
Monmouth Junction, N.J.t CDLs247l?3-B)
00098345 Cordier, A.I Fournier, 1.? Viziere, ? (1981) Fosetyl-al
(32 Sys R.P., Aluminium Salt): Micronuoleus Test in
the Mouse by the Oral Routes Reference C.R.
Vitry/C.N.G. Ho. 21 186-E. (translation, unpublished
study received Apr 5, 1982 under 359-705? prepared by
Rhone-Poulenc industries, France, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.?
CDL:247173-D)
41
-------
00098347 Pasquet, j.f Le Bail, R.j Cegeral, ? (Ii7«) Compound LS
74-783? Oral Teratogenicity Study in the Rabbits
Report R.P./R.D./C.N.G, No. 18917-F. (Translation?
unpublished study received Apr 5, 1S82 under 359-705?
prepared by Rhone-Poulene, France, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.? CDL:247174-A)
00098348 Palmer, A.X.? Bottomley, A.M.? Barton, S.J.j at al.
(1981) Effect of LS 74-783 on Reproductive Function
of Multiple Generations in the Rat: RNP/89/80745.
{Unpublished study received Apr 5, 1982 under
359-705? prepared by Huntingdon Research centre,
England, submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:247174-C)
00098352 epicer, E.J.P.; Phillips, L.M.j Blanchard, G. f et al.
(1981) Life-time Chronic Toxicity and Carcinogenicity
Study in Satss IRDC Study No. 347-022. (Unpublished
study received Apr 5, 1982 under 359-705? prepared by
International Research and Development Corp.,
Submitted by Rhone-Poulenc Chemical Co., Monmouth
Junction, N.J.? CDLJ247176-A? 2471771 247178? 247179?
247180; 247181; 247182)
00098353 Spicer, E.J.r.i Phillips, L.K.I Richter, W.R.j et al,
(1981) 24-month Careinogenieity study in Micej
347-021. (Unpublished study received Apr S, 1982
under 359-705; prepared by international Research and
Development Corp., submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N,J.? CDL:247168-R;
247169? 2471701 247171)
00098358 Caillard, C.G.? Deregnaucourt, J.? Garret, C.? et al.
(1980) Monoethylphosphonic Acid, Aluminium Salt (LS
74 783 = 32 545 R.P., Aluminium Salt): Effects in a
Number of Pharmacological Testss R.P./R.D./C.N.G. No.
20 680-E. (Translation? unpublished study received
Apr 5, 1982 under 359-705? prepared by Rhone-Poulene,
France, submitted by Rhone-Poulenc Chemical Co., Mon-
mouth Junction, N.J.? CDL:247183-E)
00098360 Roberts, N.L.; Phillips, C.N.K. (1981) The Acute Oral
Toxieitv (LD550") of LS 74.783 to the Bobwhite Quails
RNP 189 WL/81148. Final rept. (Unpublished study
received Apr 5, 1982 under 359-705? prepared by
Huntingdon Research Centre, England, submitted
by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:247184-B)
42
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00098362 Roberts, N.L.? Phillips, C.H.K.f Almond, R.H. (1982)
Subaetite Dietary Toxicity (LCsSQ'J of LS 74.783 to
the Bobwhite Quail:RHP 190 WL/81699. Final rept.
(Unpublished study received Apr sf 1982 under
359-7051 prepared by Huntingdon Research Centre,
England, submitted by Rhone-Poulenc Chemical Co.,
Honmouth Junction, N.J,; CDL:247184-D)
00098363 Roberts, N.L.I Phillips, C.N.K.; Almond, R.H. (1981) The
Bubacute Dietary Toxicity (LCsSQ*) of LS 74.783 to
the Mallard Duck: RNP 191 WL/81716. Final rept.
(Unpublished study received Apr 5, 1982 under
359-705; prepared by Huntingdon Research centre,
England, submitted by Rhone-Poulene Chemical Co.,
Monmouth Junction, N.J.J CDLf247184-E)
00098368 Rhoderick, J.C.; Spare, W.C.; Rutchinson, C. {1981} The
Acute Toxicity of Aluminum-ethyl-phosphonate to Grass
Shrimp,"Palae"i-;~monetes pugio'is Project No. 381-2.
(Unpublished study received Apr 5, 1982 under
359-705? prepared by Biospherics, Inc., submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; GDZ.S247184-J)
00098370 Buys, M.i Bertrand, A.; Giraud, J.I. (1981J Fosetyl-al
(Aluminium Tris-Q-ethylphosphonate) Hydrolysis itudyj
Raf. AG/CRtD/An/AB/MB/JFG/CB/il3,81. (Unpublished
study received Apr 5, 19S2 under 359-705? prepared by
Rhone-Foulenc Agrochemie S.A., France,
submitted by Rhone-Poulenc chemical Co., Monmouth
Junction, N.J.,* CDL:247185-B}
00098371 Bertrand, A. (1981J Fosetyl-als uv Absorption
Characteristics? Ref. No. AG/CRLD/An/Al/DB/324/81.
(Unpublished study received Apr 5, 1982 under
359-705; prepared by Rhone Poulenc Agrochimie,
France, submitted by Rhone-Poulenc chemical Co.,
Monmouth Junction, N.J.; CDL:247185-C)
00098372 Hascoet, M.? Jamet, P. (1978} Aluminium Ethylphosphite
Degradation in the Soil. (Translation? France,
Ministere de 1'Agriculture, institut National de la
Recherche Agronomicpie, Laboratoire de
Phytopharmacie; unpublished study; CDL:247185-D)
00098375 Buys, M.; Giraud, J.P. (1982} Fosetyl-al (AluminuBi
Tris-0-ethyl-phosphojiate) Soil Leaching studies: Ref.
AG/CRLD/An/AB/MB/JPG/CB/025.82. (Unpublished study
received Apr 5, 1982 under 359-705; prepared by
Rhone-Poulenc Agrochimie, France, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.;
CDL-247185-G)
43
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00103249 Broekelsby, e.j Catehpole, A.| Crouch, R. (1977)
Fungicides: Aluminum Ethyl Phosphite (LS 74.783 or
Aliette)i studies with the 14C-labelled Compound in
Viness AR/1257. (Unpublished study received Jun 8,
1982 under 359-706; prepared by May i Baker Ltd.,
Eng., submitted by Rhone-Poulenc, Inc., Monmouth
Junction, KJ; CDL:247647-B)
00103250 Laurent, M. ? Chabassol, Y. (1982) Fosetyl-al (32 545
R.P., Aluminum Salt). Pineapple Metabolism study:
Report C.8. Vitry/CNG-An No. 4412-E. (Translation?
unpublished study received Jun 8, 1982 under 359-706;
submitted by Rhone-Poulenc, Inc., Monmouth
Junction, NJ; CDL:247647-C)
00106018 Buys, K.I Giraud, J.; Alix, M.i et al. (1982)
Fosetyl—AL (Aluminum-0-ethylphosphonate): ioil
Metabolism Study: Ref. AG/CRLD/An/262.82.
(Unpublished study received Jul 13, 1982 under 359-
705; prepared by Shone-Poulene Agroehimie S.A.,
Fr.,submitted by Rhone-Poulenc, Inc., Monmouth
Junction, HJ; CDLS247820-A)
00106019 Bertrand, A.; Buys, M. (1982) Fosetyl-Al—soil Sorption
Studies? Ref. AG/CRLD/An/163.82, (Unpublished study
received Jul 13, 1982 under 359-70S? prepared by
Rhone-Poulenc Agrochimie S.A., Fr., submitted by
Rhone-Poulene, inc., Honmouth Junction, HJ?
CDL:247820-B)
00114091 Palmer, A.? James, ». (1977) Effect of LS74-783 en
Pregnancy of the Rats RNP/33/7€939. (Unpublished
study received Apr 5, 1982 under 359-705? prepared by
Huntingdon Research Centre, Ing,, submitted by
Rhone-Poulenc, inc., Monmouth Junction, NJi CDL;
247174-B)
00119§2« Spare, W. ? Hutchinson, C. (1982) The Acute Toxicity of
Fosetyl-Al to the Bluegill Eunfish ...$ Project No.
82-E-380-B. (Unpublished study received Oct 2i, 1982
under 359-701,* prepared by Biospherics, Inc.,
submitted by Rhone-Poulenc, Inc., Konmouth
Junction, KJ; CDL:248674-A)
44
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001227S1 Pasojuet, J.f Hazuret, A.; Gaildrat, P.; et al. (1981)
Fosetyl-Al (32 545 R.P., Aluminium Salt)? Aliette WP
80% (Wettable Powder Containing 80% Fosetyl-Al);
Acute Oral Toxicity in the Rat: Reference C.R.
Vitry/C.N.G. No. 21 165-E. (Translation; unpub-
lished study received Apr 5, 1982 under 359-706;
prepared by Centre Nicolas Grillet, Fr., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL;247186-B)
00122782 Pasquet, J.; Mazuret, A.; Kalifat, R.; et al. (19S1)
Fosetyl-Al (32 S45 R.P., Aluminium Salt); Aliette wp
80% (Wettable Powder Containing 80% Fosetyl-Al);
Acute Percutaneous Toxicity in the Rabbit: Reference
C.R. Vitry/C.N.G. No, 21 166-E. (Translation;
unpublished study received Apr 5, 3.982 under 359-706;
prepared by Centre Nicolas Grillet, Fr., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, SJj
CDL5247186-C)
00122783 Owen, P.; Blackett, N. (1981} Aliette (80% Fosetyl-Al)t
Acute Inhalation Toxicity study—LC50 in Rats (4 "
Hours Exposure)! Report No. 2771-198/1,
(Unpublished study received Apr 5, 1§82
under 359-706? prepared by Hazleton Laboratories
Europe, Ltd., Eng., submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJj CDLi247iS6-D>
001227S5 Pascjuet, J.i Mazuret, A. i Maratrmti et al. (1981)
Fosetyl-Al (32 545 R.P., Aluminum Salt)i Aliette WP
80% {Wettafale Powder Containing 80% Fosetyl-Al)«
Primary Skin Irritation in the Rabbits Report C.R.
Vitry/C.N.G. No. 21 168-E of 2.11.81.
(Translation? unpublished study received Apr 5, 1982
under 359-706; prepared by Centre Nicolas Grillet,
Fr,, submitted by Rhone-Poulenc, Inc., Monmouth
Junction, NJ| CDL:247186-F)
00126757 international Research and Development Corp. (1983)
Addendum i to the Final Report, Fosetyl-Al Chronic
Toxicity (2 Year) Carcinogenic!ty Study in Ratss
347-016. (unpublished study received Apr 12, 1983
under 359-705; submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJj CDLs249898-A)
00128233 International Research and Development Corp. (1981)
Chronic Toxicity (2 Year) and Carcinogencity Study in
Ratss [Fosetyl-Al!s 347-016. (Unpublished study
received Apr 5, 1982 under 359-705; submitted by
Rhone-Poulenc, Inc., Monmouth Junction, NJj CDLs
247163-A)
45
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00128S43 Spare, W.j Gottfried, G. (1983) The Acute Toxieity of
Fosetyl-Al to Daphnia aagna Straus: Biospherics
Project NO. 82-E-380DMR. (Unpublished study received
Jun 17, 1983 under 359-705; prepared by Biospherics,
Inc., submitted by Rhone-Poulene, Inc., Monmouth
Junction, NJ? CDI.5250499-A)
00128944 Conzelmann, P. i Brady, s. (1983) Acute Toxieity
Bioassay testing Fosetyl-AL on Rainbow Trout! GSRI
Project No, 413-B45-41, (Unpublished study received
Jun 17, 1983 under 359-705? prepared by
Gulf South Research Institute, submitted by Rhone
Poulenc, Inc., Monmouth Junction, NO"; CDL:250499-B)
00139527 Rhone- Poulenc, Inc. (1983) Residue Data in/on Pineapple
Resulting from Allette Dip and/or Foliar Treatments,
(Compilation? unpublished study received May 12, 1983
Under 2F2702; CDL;Q71491-A! 071592)
00147359 Hard, G. (1985) Acute ToKicity of Fosetyl-Al to Embryos
and Larvae of the Eastern Oyster (Crassostrea
virginica) s BSE No. 85-314-0200-2130. Unpublished
study prepared by Environmental Science
and Engineering, inc. 17 p.
00147360 suprenant, D. (1985) Acute Toxieity of Fosetyl-Al to
Sheepshead Minnow (Cyprinodon variegatus) j Bionomics
Report #BW-85-5-l777. Unpublished study prepared by
springborn Bionomics, Inc. 55 p.
00147361 Chabassol, ¥. (1984) Anaerobic Aquatic Metabolism
Study 8 Fosetyl-Als Ref. No. AG/CRIiD/An/241.84.
Unpublished study prepared by Rhone-Poulene
Agrochimie. 57 p.
00147569 Rhone-Poulenc Inc. (1984) tResidue Data of Aliette:.
Unpublished study. 56 p.
00148290 Rhone-Poulenc Inc. (1985) : Residue of Fosetyl-Al in
Citrus Fruits. Unpublished compilation. 273 p.
00148619 Hylin, J,; Yanagihara, R. (iggs) Residue Data in/on
Pineapple Resulting from Aliette Dip and/or Foliar
Treatments, unpublished study prepared by University
of Hawaii. 3 IS p.
00165341 Rhone Poulenc Inc. (19??) Determination of Residues of
Fosethyl and Phosphorus Acid in Pineapples (Analysis
by Gas- liquid Chroma tography) s AG/RD/An,AB/SV
-283.82. Unpublished study, 21 p.
46
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40131101 Auletta, C.; Hogan, 6.; Lamb, c. (1982) Eye Irritation
study of Rabbits with Aliete 80 WP: Lab Project ID;
4090-82. unpublished study prepared by Bio/dynamics,
Inc. 17 p.
40285600 interregional Research Project Ho. 4. (1987) Submission
of Residue Chemistry Data in Support of the Proposed
Tolerance for Aliette on Ginseng. Transmittal of I
study.
40285601 Guyton, C. (1987) Aliette--Magnitude of Residue on
Ginseng, Including a Description of the analytical
Method Used; Ref. No. 87/BHL/1S3/AO5 Report No. ASD
87/229. unpublished study prepared by Rhone-Poulenc,
Inc. 87 p.
40600800 Interregional Research Project No. 4 (1988) Submission
of Residue Data to Support the Fosetyl-aluminum
Petition. Transmittal of 1 study.
40600801 Gemma, A.? Chow* W.j Biehn, w (1988) Fosetyl-aluminum
—in/on Ginseng, (Amendment—IR-4 Petition 7E 35S6,
MRID 40285601, Rci/EPA 4 Kov 87 Response Letter)i
Project No. 781R14; IR-4 PR 13001. Unpublished study
prepared by Rhone-Poulene Ag Co. 16 p.
40625101 Auletta, C. (1988) Eye Irritation Study in Rabbits with
Aliette HP* project Mo. 4778-S8. Unpublished study
prepared by Bio/dynamics Inc. 17 p.
406S4300 Mobay Corp. (1988) Submission of Toxieity Data to
Support the Registration of Dylox S% Granular.
Transmittal of 6 studies.
40654301 Eigenberg, D, (1988) Acute Oral Toxieity of a Dylox 5%
Formulation in Albino Rats: Study No. 87-011-06;
95692. Unpublished study prepared by Mobay Chemical
Corp. 20 p.
40676301 Hinken, C.I Dinglefline, J.? Jaber, M. (1986) Fosetyl-Als
An Acute Contact Toxicity Study with Honey Bees:
Froj. Ho. 171-110. Unpublished study prepared by
Wildlife International Ltd. 15 p.
40676401 Smith, 8. (1986) Dermal Sensitization Study in Guinea
Pigs with Aliette 80WP: Study 480-2461. Unpublished
study prepared by American Biogenics Corp. 28 p.
47
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40747701 Guyton, c.f Chow, w, (1988) Fosetyl-Al Residues in
Caneberries Resulting from Multiple Applications of
Aliette 80 WP: Project Ho. 781R10. Unpublished study
prepared by Rhone-Poulenc in cooperation with
Rhone-Poulenc Ag Co. 151 p.
40833100 Interregional Research Project Mo. 4 (1988) Submission
of Data fo Support Registration of Fosetyl-aluminum:
Residue Chemistry Data. Transmittal of 1 study.
40833101 Gemma, A.? chow, w.; Biehn, W. (1988) Fosetyl-Aluminum
—in/on Ginseng (... RCB/EPA 13 Jul 88 Response
Letter)! Project No. 781R14I File Ho. 40263; IE-4 PS
Ho. 3001. Unpublished study prepared by
Rhone-Poulenc Ag Co. 20 p.
40901601 Scarborough, D. (1988) Section A: The Names, Chemical
Identity, and Composition of Aliette Fungicide: Project
ID: 781C10? File No. 40424. Unpublished study prepared
by Rhone-Poulenc Ag Co. 14 p*
40901602 Guyot, c.? Scarborough, D, (1988) Fosetyl-Al Technical!
Product chemistry: Project ID: 781C10? File Mo.
40408. Unpublished study prepared by Rhone-Poulenc
Agroehimie. 4 p.
41001701 Gemma, A. y Chow, W. (1988) Residues of Fosetyl-Al in/on
Citrus Fruit Resulting from Multiple Applications of
Aliette SO WP: Laboratory Project ID 781 R14.
unpublished study prepared by Rhone-Poulenc, Inc.
221 p.
41034500 Rhone-Poulenc Ag Co. (1989) Submission of Data To
Support Registration Petition for Fosetyl-Al: Product
Chemistry Data. Transmittal of 1 study.
41034501 Rhoads, w. (1988) Determination of the Characteristics
of Fbsetyl-Al when Subjected to Analysis by the
United States Food and Drug Administration (FDA)
Multi-Residue Protocols I,II,III and ivs
Project No, Rbone-Poulenc 1087. Unpublished study
prepared by Colorado Analytical Research &
Development Corp. 114 p.
41036301 Scarborough, D. (2.989) Certification of Ingredient.
Limits for Aliette Fungicide: Section A: Project File
No. 40521. Unpublished compilation prepared by
Rhone-Foulenc ng Co. 17 p.
48
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41049901 White, 8. (1989} Final Report for Dissipation of
Dislodgable Fosetyl-Al (Aliette) Residue Applied to
Citrus in California: Project ID Nos: Study No. 1068?
WRLA Protocol NO. 1321-87-44-03-01A-03. Unpublished
study prepared by Colorado Analytical in
cooperation with Research for Hire. 139 p.
41128601 Hughes, J. (1989) The Toxicity of Fosetyl-Al to
Savicula pellieulosas Proj. ID 1163-01-1100-3.
Unpublished compilation prepared in cooperation with
Malcolm Pirnie, inc. and Biospherics Inc. 4 p.
41128602 Hughes, j. (1989) The Toxicity of Fosetyl-Al to Anabaena
flosaguae: Proj. ID 1163-01-1100-2. Unpublished
compilation prepared in cooperation with Malcolm
Pirnie/ Inc. and Biospherics Inc. 42 p*
41128603 Hughes, J, (1988) The Toxicity of Fosetyl-Al to Lemna
gibba 83: Proj. ID 1163-01-1100-S. Unpublished
compilation prepared in cooperation with Malcolm
Pirnie, Inc. and Biospherics Inc. 40 p.
41128604 Hughes, J. (1989} The Toxicity of Fosetyl-Al to
Selenastrum capricornutum: Proj. ID 1163-01-1100-1.
Unpublished compilation prepared in cooperation with
Malcolm Pirnie, Inc. and Biospherics Inc. 41 p.
41128605 Hughes, J, (1989} The Toxicity of Fosetyl-Al to
SXeletonerna costaturn: Proj* ID 1163-01-1100-4.
Unpublished compilation prepared in cooperation with
Malcolm Pirnie, Inc. and Rhone-Poulene Ag Co. 30 p.
41133001 Stumpner, J.i Predmore, L. (1987) Metabolism of Carbon
14 Fosetyl-Al in Lactacting Dairy Goats: Projects ID
No. ABC 32637. Unpublished study prepared by ABC
Laboratories. 873 p.
41286401 Helfant, L, (1989) Fosetyl-Al Corrosion Characteristics
of Aliette Brand Fungicide: Series 63; Guideline
63-20: Lab project Number: 781 CIO: 40670: 9426-8.
Unpublished study prepared by Rhone-Foulenc Ag Co.
and Midwest Research Institute, Contract
Laboratory/Corrosion Evaluation. 69 p.
49
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