United States                             Office of Prevention, Pesticides and Toxic
Environmental Protection Agency              Substances (7505P)



        e CDA          Pesticide


                            Fact  Sheet


   Name of Chemical:       Flubendiamide
   Reason for Issuance:     Conditional Registration
   Date Issued:              August 1, 2008


DESCRIPTION OF CHEMICAL

   Generic Name:            N2-[ 1,1 -Dimethyl^-CmethylsulfonyOethylJ-B-iodo-N1 -[2-methyl-
                          4-[l ,2,2,2-tetrafluoro-l -(trifluoromethyl)ethyl]phenyl]-l ,2-
                          benzenedicarboxamide

   Common Name:            Flubendiamide

   EPA Chemical Code:        027602

   Chemical Abstracts
   Service (CAS) Number:      272451 -65-7

   Pesticide Type:            Insecticide

   Chemical Type:            Phthalic Acid Diamide

   U.S. Producer:            Bayer CropScience LP
                          2 T.W. Alexander Drive
                          Research Triangle Park, NC 27709-2014

-------
USE PATTERNS AND FORMULATIONS

   Application Sites:      Flubendiamide is registered for use on corn, cotton,
                          tobacco, pome and stone fruit, tree nut crops, grapes and
                          vegetable crops (including cucurbit vegetables, fruiting
                          vegetables and okra, leafy vegetables [except Brassica] and
                          Brassica [cole] leafy vegetables).

   Types of
   Formulations:         NNI-0001 Technical (manufacturing concentrate)
                          NNI-0001 24 WG Insecticide (water dispersible granule)
                          NNI-0001 480 SC Insecticide (soluble concentrate)

   Application Methods and Rates: Flubendiamide acts against various lepidopterous
   insect pests such as armyworms, bollworms, corn borers, cutworms, diamondback
   moths, fruitworms and loopers. Foliar spray applications can be made by aerial,
   ground or chemigation application on all crops as needed for insect control.  Single
   application rates range from 0.03 to 0.16 Ib. a.i./A and can be applied 3-5 times per
   season. Seasonal application rates range from 0.09 to 0.47 Ib.  a.i./A. Pre-harvest
   intervals (PHIs) range from 1 to 28 days. The proposed reentry interval (REI) is 12
   hours on both labels. NNI-0001 24 WG Insecticide is a 24% a.i. water dispersible
   granule. NNI-0001 480 SC Insecticide is a 39% a.i. soluble concentrate.

HUMAN HEALTH RISK ASSESSMENT

   Hazard and risk assessments were conducted in relation to this registration
   application and tolerance petition for the use of flubendiamide on corn, cotton,
   tobacco, tree fruit, free nuts, vine crops and vegetable crops and suggest that its use,
   consistent with the proposed labeling measures, will be protective of the public health
   and the environment.

   Acute Toxicity: Flubendiamide has a low order of acute toxicity via the oral, dermal
   and inhalation routes (Category III). Though it is a slight irritant to the eye,
   flubendiamide is not a skin irritant and it is not a skin sensitizer.  The acute toxicity
   findings for flubendiamide are summarized below:

   Acute Oral Toxicity: III
   Acute Dermal  Toxicity: III
   Acute Inhalation: III
   Primary Eye Irritation: IV
   Primary Dermal Irritation: IV
   Dermal Sensitization: Negative

   Other Toxicity: In the longer-term studies in the flubendianiide mammalian
   toxicology database, the primary target organs identified were the liver, thyroid,
   kidney and eyes. Liver effects reported in rats, mice and/or dogs include organ

-------
weight increase, periportal fatty change, hypertrophy, and minimal foci of cellular
alteration. Thyroid effects include organ weight increase, follicular cell hypertrophy
and slight perturbations of triiodothyronine (T3) and thyroid stimulating hormone
(TSH) in the rat and mouse. Kidney effects include increases in absolute and/or
relative to body kidney weights and chronic nephropathy in the rat.  Eye effects
include eye enlargement, opacity, and exophthalmus with hemorrhage and appear
only in rat pups. Other changes include mild microcytic anemia, decreased serum
triglycerides and cholesterol in female rat, increased gamma glutamyl peptidase,
alkaline phosphatase and shortened activated prothrombin time in dogs and adrenal
weight increase and increase in adrenal cortical cell hypertrophy in dogs.

The hazard assessment indicated potential toxicity resulting from exposure to
flubendiamide via different routes over different durations. The observed eye effects
were selected as a critical effect for the acute dietary exposure scenario; whereas liver
and thyroid effects were determined critical for the chronic dietary exposure scenario.
Short- and intermediate-term dermal risks were also based on liver and thyroid
effects, as well as blood  effects. Short- and intermediate-term inhalation risks are
based on liver toxicity, as well as adrenal weight increase and an increase in adrenal
cortical cell hypertrophy.

Metabolism: Rat metabolism studies at low and high doses report fairly rapid
absorption, with peak blood and plasma levels reached at approximately 6 to 12 hours
post-dosing followed by a continuous decline.  The NNI-0001 was fairly well
distributed among blood and most of the organs and tissues, with some preference to
the liver, adrenal glands, and fat.  Generally, the liver and kidneys contained the
greatest percentage of the administered dose. Excretion of NNI-0001 residues was
rapid (majority of radioactivity recovered at the first 24-hour collection point), with
feces being the predominant route of excretion. Renal excretion accounted for only
2% and <1% of the dose in male and female rats, respectively.  Parent NNI-0001,
NNI-0001 -benzylalcohol (A-16) and NNI-0001-benzoic acid (A-18) were the major
residues identified  in the feces. Additionally, metabolite A-14 was identified in the
fat of female rats at 1% of the administered dose.

In vitro metabolism and  toxicokinetic studies in multiple mammalian species appear
to confirm the findings reported in the in vivo rat metabolism study, that female rats
appear to metabolize the parent compound differently from male rats and other
species. Female rats do not show an ability to  convert the parent compound to the
metabolite A-16 due to the lack of P-NADPH that is required for metabolism,
indicating there was no abiotic degradation of the test compound in the test systems.
The lack of abiotic degradation and the longer terminal elimination half-life of the
parent compound in the female rats, differentiate them from other test animals.

Endpoints

Acute: The 2-generation reproduction, 1-generation reproduction and DNT studies,
as 3 co-critical studies, were selected for the acute reference dose (aRfD) of 0.995

-------
mg/kg/day using 99.5 mg/kg/day from the DNT study (the highest NOAEL) and a
LOAEL from the 1-generation reproduction study of 127 mg/kg/day (the lowest
LOAEL) based on buphthalmia (enlargement of eyes), ocular opacity, retinal
degeneration, hemorrhage, cataract and atrophy of the optic nerve. The
NOAEL/LOAEL chosen result in a more refined yet health protective acute dietary
risk assessment.

The weight of evidence from various studies suggest that the finding of enlarged
eyeballs in rat offspring is a rat-specific phenomenon, resulting from exposure to
higher steady-state concentrations of flubendiamide which may be due to the
uniquely diminished capacity of the female rat to oxidize the parent compound. While
human microsomes have been shown to be capable of approximately 4 times higher
hydroxylation rates than female mouse microsomes and may be able to efficiently
metabolize/excrete flubendiamide, preventing accumulation of the parent compound,
it remains unclear whether this ability is the only requirement to avoid ocular toxicity.
Due to the potential concern for increased susceptibility of human neonates vs. adults,
this perinatal ocular effect is considered in the HED risk assessment.

Chronic: The 1-year chronic rat study, 1-year chronic dog study and the 24-month rat
carcinogenicity study were selected as 3 co-critical studies for the chronic reference
dose (cRfD) of 0.024 mg/kg/day with a NOAEL/LOAEL of 2.4/33.9 mg/kg/day
(highest NOAEL of 2.4 mg/kg/day from 1-year chronic rat study and lowest LOAEL
of 33.9 mg/kg/day from 24-month rat study. Although the 1-year dog study had
NOAELs of 2.21/2.51 mg/kg/day, the lowest NOAELs from each study were
considered when comparing NOAELs among the 3 studies, respectively, based on the
consistent liver toxicity reported across multiple studies, different durations and
multiple species. The NOAEL/LOAEL chosen are protective of effects seen in other
long-term studies.

Carcinogenicity: Flubendiamide is considered to be "Not Likely to be Carcinogenic
to Humans."  There was no evidence of carcinogenicity in rats and mice up to the
limit dose at 24- and 18-months, respectively.  Flubendiamide was determined to be
non-mutagenic in bacteria, negative in an in vivo mammalian cytogenetics  assay and
did not cause unscheduled DNA synthesis (repair of DNA damage) in mammalian
cells in vitro.  Overall, there  was no clear evidence that flubendiamide was either
mutagenic or clastogenic in either in vivo or in vitro assays. Quantification of cancer
risk is; therefore, not needed for flubendiamide.

FQPA Safety Factor: EPA  evaluated the quality of the toxicity/exposure data and
has determined that the safety of infants and children would be adequately protected
if the FQPA safety factor (SF) were reduced to Ix based on the following findings:
(1) The toxicology database  for flubendiamide is complete for purposes of risk
assessment and the characterization of potential pre- and/or post-natal risks to infants
and children.  Although susceptibility was identified in the toxicological database
(eye effects), the selected regulatory PODs (which are based on clear NOAELs) are
protective of these effects; therefore, the human health risk assessment is protective;

-------
(2) There are no treatment-related neurotoxic findings in the acute neurotoxicity and
DNT studies in rats. Although eye effects were observed in the DNT study, the
PODs employed in the HED risk assessment are protective of this effect; and (3)
There are no residual uncertainties identified in the exposure databases and the
exposure assessment is protective.

Dietary Exposure

Acute Risk: The acute dietary analysis assumed that 100% of crops with requested
uses of flubendiamide are treated and that all treated crops contain residues at
tolerance-level. In addition, tolerance-level residues for livestock commodities were
included in these analyses to account for the potential transfer of plant residues to
livestock tissues. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.  For acute dietary risk assessment, the water
concentration value of 12.93 ppb was used to assess the contribution to drinking
water. These assumptions result in conservative, health-protective estimates of
exposure which are well below the Agency's LOG (100% of the aPAD). The
maximum exposure estimate is less than 8% of the aPAD for the most highly
exposed population subgroup, children 1-2 years old. These analyses indicate
that there are no acute dietary exposure considerations that would preclude
registration of flubendiamide for the requested uses.

Chronic Risk: The chronic dietary analysis assumed that 100% of requested crops
are treated and that all treated crops contain residues at the average residue levels
found in the crop field trials and experimentally-determined processing factors where
available.  In addition, average-level residues for livestock commodities were also
included in these analyses to account for the potential transfer of plant residues to
livestock tissues. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.  For chronic dietary risk assessment, the
water concentration value of 11.95 ppb was used to assess the contribution to
drinking water. These assumptions result in conservative, health-protective estimates
of exposure which are well below the Agency's LOG (100% of the cPAD).  The
maximum exposure estimate is less than 15% of the cPAD the most highly
exposed population subgroup, children 1-2 years old. These analyses indicate
that there are no chronic dietary exposure considerations that would preclude
registration of flubendiamide for the requested uses.

Aggregate Risk: The aggregate risk assessment considers dietary exposures from
food and drinking water to flubendiamide consumed over the acute and chronic
durations.  Acute and chronic dietary exposure is well below the Agency's LOG
and there are no acute or chronic dietary exposure considerations that would
preclude registration of flubendiamide for the requested uses.

Residue Chemistry: The nature of the residue in plants, rotational crops and
ruminants is  adequately understood. For the purposes of tolerance establishment and

-------
dietary/drinking water risk assessment, the residue of concern in plants, animals and
rotational crops is the parent flubendiamide/?er se.

Tolerances have been established in 40 CFR §180.639 in or on the following food
commodities: almond, hulls (9.0 ppm); apple, wet pomace (2.0 ppm); brassica, head
and stem, subgroup 5A (0.60 ppm); brassica, leafy greens, subgroup 5B (5.0 ppm);
cattle, fat (0.30 ppm); cattle, kidney (0.30 ppm); cattle, liver (0.30 ppm); cattle,
muscle (0.05 ppm); corn, field, forage (8.0 ppm); corn, field,  grain (0.02 ppm); corn,
field, stover (15 ppm); corn, pop, grain (0.02 ppm); corn, pop, stover (15 ppm); corn,
sweet, forage (9.0 ppm); corn, sweet, kernel plus cob with husks removed (0.01 ppm);
corn, sweet, stover (25 ppm); cotton gin byproducts (60 ppm); cotton, undelinted seed
(0.90 ppm); egg (0.01 ppm); fruit, pome, group 11 (0.70 ppm); fruit, stone, group 12
(1.6 ppm); goat, fat (0.30 ppm); goat, kidney (0.30 ppm); goat, liver (0.30 ppm); goat,
muscle (0.05 ppm); grain, aspirated fractions (5.0 ppm); grape (1.4 ppm); horse, fat
(0.30 ppm); horse, kidney (0.30 ppm); horse, liver (0.30 ppm); horse, muscle (0.05
ppm); milk (0.04 ppm); milk, fat (0.30 ppm); nut, tree, group 14 (0.06 ppm); okra
(0.30 ppm); poultry, fat (0.02 ppm); poultry, liver (0.01 ppm); poultry, muscle (0.01
ppm); sheep, fat (0.30 ppm); sheep, kidney (0.30 ppm); sheep, liver  (0.30 ppm);
sheep, muscle (0.05 ppm); vegetable, cucurbit, group 9 (0.20 ppm); vegetable,
fruiting, group 8 (0.60 ppm) and vegetable, leafy, except brassica, group 4(11 ppm);
and in or on the following raw agricultural commodities: alfalfa, forage (0.15 ppm);
alfalfa, hay (0.04 ppm); barley, hay (0.04 ppm); barley, straw (0.07 ppm); buckwheat
(0.07 ppm); clover, forage (0.15 ppm); clover, hay (0.04 ppm); grass, forage (0.15
ppm); grass, hay (0.04 ppm); millet, pearl, forage (0.15 ppm); millet, pearl, hay (0.04
ppm); millet, proso, forage (0.15 ppm); millet, proso, hay  (0.04 ppm); millet, proso,
straw (0.07 ppm); oats, forage (0.15 ppm); oats, hay (0.04 ppm); oats, straw (0.07
ppm); rye, forage (0.15 ppm); rye, straw (0.07 ppm); sorghum, grain, forage (0.03
ppm); sorghum, grain, stover (0.06 ppm);  soybean, forage (0.02 ppm); soybean, hay
(0.04 ppm); teosinte, forage (0.15 ppm); teosinte, hay (0.04 ppm); teosinte, straw
(0.07 ppm); triticale, forage (0.15 ppm); triticale, hay (0.04 ppm); triticale, straw
(0.07 ppm); wheat, forage (0.15 ppm); wheat, hay (0.03 ppm) and wheat, straw (0.03
ppm).

At this time, there are currently no established CODEX, Canadian or Mexican MRLs
established for residues of flubendiamide/?er se in crop or livestock commodities.

Occupational: No chemical-specific data for assessing human exposures during
pesticide handling activities were submitted in support of the registration of
flubendiamide. EPA used surrogate data from the PHED Version 1.1 (PHED
Surrogate Exposure Guide, August 1998) to assess exposures. The level of concern is
a Margin of Exposure (MOE) of less than 100. All occupational handler MOEs for
flubendiamide are estimated to be greater than 100 at some level of risk
mitigation for the proposed uses. Combined dermal plus inhalation risks are not a
concern, provided that: (1) Baseline attire (long-sleeved shirt and long pants and
shoes plus socks) is worn by all occupational handlers; (2) Handlers mixing and
loading liquid concentrates to support aerial and chemigation applications wear

-------
   chemical-resistant gloves such as barrier laminate, butyl rubber, nitrile rubber or
   viton; and (3) Pilots use enclosed cockpits.

   There is the possibility for agricultural workers to have post-application exposure to
   flubendiamide following its proposed agricultural crop uses. Therefore, occupational
   post-application exposures and risks were assessed using data from flubendiamide-
   specific DFR studies and using EPA's default assumptions that 20% of the initial
   application is available for transfer on day 0 (i.e., 12 hours after application) and that
   the residue dissipates at a rate of 10% per day following treatment.

   For flubendiamide, the exposure durations for non-cancer post-application risk
   assessment were short- (1 to. 30 days) and intermediate-term (>30 days and up to
   several months). However,  since the dermal toxicological endpoint of concern is the
   same for short- and intermediate-term exposures, the short- and intermediate-term
   post-application risks are numerically identical.  Inhalation exposures are thought
   to be negligible hi outdoor post-application scenarios, since flubendiamide has a
   relatively low vapor pressure (7.5 x 107 mm Hg).

   It should be noted that the grape and corn flubendiamide-specific DFR data indicate
   that flubendiamide does not dissipate characteristically in a steady state. Rather, there
   is evident fluctuation up and then down, though the ultimate trend is downwards. In
   fact, the highest residue value detected in the entire study was detected on corn on the
   2nd day after the last treatment. That observation (0.390 ug/cm2) is higher than the
   residue value calculated for  corn using EPA default assumptions (0.21 ug/cm2) by a
   factor of 1.86 (0.390/0.21 =  1.86).  To ensure that the post-application assessments,
   using default DFRs are protective, EPA conducted a highly conservative assessment
   assuming that all the default DFRs would be 1.86x higher if flubendiamide-specific
   data were generated on each of those crops (an assumption that is not likely, since  in
   the case of grapes, the DFR  residues were less than the default assumptions).
   Therefore, even when assuming an extraordinarily worse-case scenario, post-
   application exposure to flubendiamide does not pose a risk to occupational
   workers.

   Flubendiamide is classified in acute toxicity category III for acute dermal toxicity and
   category IV for primary eye irritation and primary skin irritation.  It is not a dermal
   sensitizer. A restricted entry interval (REI) of 12 hours is appropriate and meets
   the requirements of the Worker Protection Standard for Agricultural Pesticides
   (WPS).

ENVIRONMENTAL RISK ASSESSMENT

   Ecological Effects

   The Agency has determined, based on the proposed uses, that there is no potential
   risk to freshwater and marine fish, marine crustaceans, marine mollusks and aquatic
   plants at the limit of solubility for parent flubendiamide. In addition, there is no

-------
potential acute risk or reproductive effects to birds and mammals, earthworms,
beneficial insects including honey bees and natural Lepidoptera predators, and
terrestrial plants for all of the proposed uses.

There is a potential risk to freshwater benthic invertebrates exposed to flubendiamide
and its degradate des-iodo. EPA has compared the body of toxicological data for the
parent compound and des-iodo. With the possible exception of chronic testing with
chironomid midges, there is no apparent difference in toxicity evident from the
available data. In the case of the chironomid data, conversion of effect endpoints to
pore water units results in an estimated NOAEC for the parent compound of
approximately 1 ug/L. The corresponding NOAEC for des-iodo  is  0.28 ug/L.
Because of the estimated nature of the parent compound NOAEC (the value is
estimated from the relationship between nominal and pore water measurements at
other dose levels because actual measurements of pore water concentrations were not
made at the NOAEC  level) and because NOAEC comparisons are usually
confounded by the dose selections at study design onset, EPA concluded that there
was insufficient data  to demonstrate a significant difference in toxicity between the
parent and degradate. However, for the purposes of risk assessment and in
consideration of the use of data as prescribed in the Agency's Risk Assessment
Overview Document, risk calculations are based on the chronic endpoints established
for each chemical, specifically.

Using these NOAEC  values, RQs for parent flubendiamide would range from 0.94 to
21.3.  Considering only the accumulation within the first 30 years of use for all of the
crop scenarios, RQs for the des-iodo degradate would range from 0.03 to 6.9 in the 1st
year, 2.9 to 64 in the  10th year, 4.9 to 127 in the 20th year and 12 to  190 in the 30th
year.  Uncertainties in the model results make longer term estimates of accumulation
and risk unreliable. However, due to the persistence of both the parent and degradate,
there is a concern for potential accumulation in aquatic sediments over time.

Testing of the formulated products 480 SC and 24 WG resulted in RQs ranging up to
0.1 for freshwater invertebrates. Results of a mesocosm study conducted with the
formulated products also did not identify any serious risk concerns for water column
invertebrates.

Adult ladybird beetles are potentially at risk due to ingestion of food items (aphids
and pollen) containing flubendiamide residues. In addition, there is a potential direct
risk to non-target lepidopterous species, including endangered species. Lepidoptera
may occur in areas adjacent to treated fields, where they may be exposed to spray
drift, and will likely move through treated fields. Further, the larvae of some
lepidopterous species are aquatic and; therefore, may be exposed to both the parent
formulation and the des-iodo degradate.

The Agency is concerned about the possible accumulation of flubendiamide and des-
iodo in aquatic sediments and the  effects that this would have on  freshwater benthic
organisms. However, given the benefits described below, the Agency is granting

-------
registration for this chemical at this time.  The risk mitigation required and conditions
of registration for this chemical, as described below, are designed to address these
concerns and to provide adequate information that will allow the Agency to
determine: (1) if the required risk mitigation is adequate or, if this is still uncertain;
and (2) through a monitoring program, determine the rate and extent of accumulation
of the parent and degradate in the most vulnerable areas of use during the time period
of the 5-year conditional registration.

Environmental Fate and Transport

Hydrolysis/Photolysis: Flubendiamide is stable to hydrolysis under laboratory
conditions, but direct aqueous photolysis appears to be a main route of degradation.
Flubendiamide degrades to NNI-OOOl-des-iodo (des-iodo), with a half-life estimated
as 11.56 days. Flubendiamide degrades to des-iodo under laboratory soil photolysis
with a half-life estimated as 35.3 days. Volatilization from soil and water surfaces is
not expected to be an important dissipation route since flubendiamide has a relatively
low vapor pressure (7.5 x 10"7mm Hg) and Henry's Law constant (8.9 x  10"11
atm-m /mol).

Mobility/Transport: Flubendiamide is expected to be slightly to hardly mobile (KFoc
= 1,076 to 3,318 L/Kg).  Des-iodo is expected to be moderately mobile (KFoc = 234
to 581 L/kg). The main transformation product,  des-iodo, is more mobile than the
parent; however, des-iodo  was only detected in a small quantity (<3.4% of the
applied) at the 0 to 15 cm soil depth at 3 sites in the terrestrial field studies.
Flubendiamide and des-iodo have the potential to contaminate surface water through
run-off due to their persistence in soil and also have the potential for groundwater
contamination in vulnerable soils with low organic carbon content,  after heavy
rainfall and/or in areas with high water tables (because there is less depth to travel
before reaching groundwater).

Soil/Water Degradation: Flubendiamide is stable under aerobic and anaerobic soil
metabolism and aerobic aquatic metabolism laboratory conditions.  In aerobic and
anaerobic aqueous environments, flubendiamide is expected to dissipate somewhat
faster than in aerobic soil,  likely as a result of metabolism. Laboratory experiments
using anaerobic and aerobic aquatic systems resulted in flubendiamide half-lives
(water plus soil/sediment)  of 127 to 364 days and 32.8 to 533.2 days, respectively.
Anaerobic aquatic metabolism is another main route of degradation for
flubendiamide. Flubendiamide degrades to des-iodo under anaerobic aquatic
conditions with a half-life  estimated as 365 days. Flubendiamide and des-iodo's
overall stability/persistence suggests that they will accumulate in soils, water column
and sediments with each successive application.

Terrestrial Field Dissipation: Flubendiamide also degrades in the field condition very
slowly.  In terrestrial field  experiments, flubendiamide half-lives  in 3 soils ranging
from loamy sand to silt loam were 210 to 770.2 days (leaching to a depth of 30 to 60
cm) and in a sandy loam soil under outdoor conditions, the half-life was 322 days. In
an aerobic soil environment, flubendiamide is expected to dissipate slowly, hi the

-------
   laboratory using 4 soils ranging from loamy sand to silt, flubendiamide was stable
   with <5% of the applied chemical dissipating at 371 days post-treatment.

REGULATORY DECISION

   Conditional Registration: A 5-year conditional registration has been granted for
   flubendiamide use as an insecticidal control of various lepidopterous insect pests on
   corn, cotton, tobacco, tree fruit, tree nuts, vine crops and vegetable crops.

   Flubendiamide may be a viable alternative to  comparably registered and existing
   pesticides that tend to pose greater risk concerns and may also be an important tool as
   a rotational insecticide to limit or prevent the  development of resistance to other
   insecticide chemistries.  Flubendiamide has also been identified as an OP alternative
   for the control for the control of leafroller and fruitworm pests in tree fruit
   production, where the dominant pesticides used have been azinphos-methyl,
   chlorpyrifos and phosmet.

   The EFED risk assessment; however, suggests that both flubendiamide and des-iodo
   will accumulate to concentrations in aquatic environments that will pose risk to
   freshwater benthic invertebrates.  As a result,  EPA is requiring certain measures
   which the Agency believes may be effective in mitigating the apparent risk, including
   the requirement 15-foot vegetative buffer zones which are expected to reduce run-off
   of both parent and degradate to the aquatic environment, reduced application rates
   and other labeling statements which reduce the allowable total loading in one year
   and environmental hazards, ground water and surface water advisories.

   To confirm the utility of the 15-foot vegetative buffers, the Agency is requiring a
   small-scale run-off/vegetative buffer strip study. If the utility of the 15-foot buffers
   cannot be demonstrated to achieve reductions in off-site transport and aquatic
   organism risk that would alleviate the risk concern, the Agency is requiring a
   monitoring program, the results of which allow the Agency to determine, at the end of
   the 5-year conditional registration, the rate and extent of accumulation in the most
   vulnerable use areas. If there are risk concerns at that time that result in the Agency
   being unable to determine that there are no reasonable adverse effects to the
   environment, the registrants have agreed that the pesticide will be voluntarily
   cancelled.

   Conditional Data: The registrant has committed to submit the following data:

   1. Flubendiamide
      •   (Non-guideline) Small-Scale Runoff/Vegetative Buffer Strip Study - The
          quantitative efficacy of vegetative buffers for flubendiamide use is uncertain.
          To determine the magnitude of the parent, flubendiamide, retained in  buffer
          strips, the small-scale run-off/vegetative buffer strip study and monitoring
          program will allow the Agency to quantitatively consider the impact of such
          buffers on the risk picture. The protocols for the studies will be mindful of the

-------
          need to both consider the variety of proposed use sites as well as a variety of
          buffer conditions.

          If the employment of label enforceable buffers is empirically demonstrated to
          alleviate the risk concern, then no further work need be conducted. However,
          if buffers cannot be demonstrated to achieve these meaningful risk reductions,
          the other areas of critical uncertainty in the modeling assumptions must be
          considered.  In this case, there is considerable uncertainty in the application of
          the EXAMS pond scenario for chemicals with suspected aquatic system
          accumulation. Additional information on the actual potential for the pesticide
          to build up in receiving waters would address the uncertainty associated with
          current model limitations. Therefore, a monitoring study of receiving waters
          within watersheds where flubendiamide will be used will be required.

    2.  Des-iodo Degradate
       •  (161-1) Hydrolysis - A hydrolysis study to establish the significance of
          chemical hydrolysis as a route of degradation for des-iodo and to identify, if
          possible, the hydrolytic products formed to provide initial information on
          whether they may exhibit structures that may potentially adversely affect non-
          target organisms.

       •  (162-4) Aerobic Aquatic Metabolism - An aerobic aquatic metabolism study
          to determine the effects of des-iodo on aerobic conditions in water and
          sediments during the period of dispersal of des-iodo throughout the aquatic
          environment and to compare rates and formation of metabolites.  The data
          from this study would provide the aerobic aquatic input parameter for
          PRZM/EXAMS; therefore, potentially reducing modeling uncertainty.

    3.  For the submitted GLN 860.1850 Confined Rotational Crop studies (MRIDs
       46817133 and 46817134), the registrant will submit extraction and analysis dates
       of samples in order to confirm that samples were extracted and analyzed  within
       the stated intervals (or within 6 months of harvest). Otherwise, additional storage
       stability data may be required by EPA.

BENEFIT DETERMINATIONS: Since flubendiamide is a novel chemistry, the
Agency believes that it may be a viable alternative to comparably registered and existing
pesticides that tend to pose greater risk concerns. Also, it may be an important tool as a
rotational insecticide to limit or prevent the development of resistance  to other insecticide
chemistries.  BEAD'S preliminary analysis of the material submitted by the registrant
concludes that flubendiamide provides Lepidoptera control equivalent  or superior to the
insecticides currently being used for pest control in the evaluated crops.  Materials
submitted also suggest low toxicity to terrestrial insect predators and honey bees which
should make flubendiamide an important component in IPM programs.

When assessing recent pesticide usage data for currently registered insecticide products
aimed at controlling lepidopterous pests in corn, several market leaders are of concern to

-------
       the Agency.  Flubendiamide's toxicity to terrestrial organisms is low, especially in
       comparison to the current active ingredients most commonly used against the labeled
       target pests.

       For pesticides used to control cotton pests such as the beet armyworm and bollworm, the
       usage information for products used in 2007 was more broadly distributed among
       chemical pesticides than that indicated for corn usage, with a number of synthetic
       pyrethroids, namely lambda cyhalothrin, and other chemistries such as acephate and
       chlorpyrifos leading the usage profile.

       In addition, flubendiamide has been identified as an organophosphorus pesticide
       alternative for the control of leafroller and fruitworm pests in tree fruit production, where
       the dominant pesticides used have been azinphos-methyl, chlorpyrifos and phosmet.
       Therefore, flubendiamide is a chemical that broadens the diversity of pest control
       measures available to growers for the reasons stated above.

REQUIRED LABEL STATEMENTS

   The end-use product labels containing flubendiamide as an active ingredient will be amended
   as follows:

   1.  Requirement of 15-foot vegetative buffer zones and the addition updated spray drift
       language for aerial/ground applications for similar products with similar use patterns on
       both end-use labels.

   2.  On the proposed label for 24 WG, the registrant will reduce application rates, revise the
       maximum amount of product applied per acre "per year" to a "per crop season" basis and
       remove the number of applications per crop season  for the Brassica, Cucurbits,  Leafy
       Vegetables and Fruiting Vegetables crop groupings in order to reduce the per year
       loading allowed.

   3.  Addition of revised environmental hazards, ground  water and surface water advisories to
       both end-use labels.

   4.  On the proposed label for 480 SC, the registrant will be required to clearly articulate what
       application method(s) are proposed for each listed crop.

   5.  The proposed rotational crop restriction for root crops (root, tuber and bulb vegetables),
       which specifies that "treated areas may be replanted immediately following harvest, or
       as soon as practical following the last application"  will be revised to  a 30-day plant-back
       interval on both end-use labels.

GOVERNMENT PERFORMANCE AND RESULTS ACT (GPRA)

   Registering flubendiamide will meet the objectives of GPRA title 3.1.1 by assuring new
   pesticides that enter the market are safe for humans and the environment.

-------
CONTACT PERSON AT EPA

   Mailing Address:

   Mr. Richard J. Gebken,
   Product Manager (10)
   Environmental Protection Agency
   Office of Pesticide Programs
   Registration Division (7505P)
   Insecticide Branch
   1200 Pennsylvania Avenue, NW.
   Washington, D.C. 20460-0001

   Office Location and Telephone Number:

   Room S-7319, One Potomac Yard
   2777 S.  Crystal Drive
   Arlington, VA 22202-4501
   703-308-9354
DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational
purposes only and may not be used to fill data requirements for pesticide registration. The
information is believed to be accurate as of the date on the document.

-------
Appendix 1 — Structure and Nomenclature
Flubendiamide Nomenclature
Chemical structure
Empirical Formula
Common name
Company experimental name
IUPAC name
CAS name
CAS registry number
End-use products (EPs)
Chemical Class
Known Impurities of Concern

[ O HjC CHj
^^,A^N^X^/S02CH3
TJ
\^Y>°
IW\vxx^>N
!
/^\-t?^^ ^-CF,
IT *~- \X^ \.-^ 3
^ P\
CF3
C23H22F7IN204S
Flubendiamide (proposed ISO name)
NNI-0001
N2-[ 1 , 1 -Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-V - {2-methyl-4-[ 1 ,2,2,2-
tetrafluoro-l-(trifluoromethyl)ethyl]phenyl}phthalamide
A^2-[l,l-Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-V-[2-methyl-4-[l,2,2,2-
tetrafluoro- 1 -(trifluoromethyl)ethyl]phenyl] - 1 ,2-benzenedicarboxamide
272451-65-7
NNI-0001 480 SC (EPA File Symbol 264-XXX)
NNI-0001 24 WG (EPA File Symbol 264-XXX)
Phthalic acid diamide insecticide
None

-------
Appendix 2 -- Physical and Chemical Properties
Physicochemical Properties of Flubendiamide.
Parameter
Molecular weight
Melting point/range
PH
Density
Water solubility
Solvent solubility
Vapor pressure
Dissociation constant, pKa
Octanol/water partition coefficient,
Log(Kow)
UV/visible absorption spectrum
Value
682.39 g/mol
217.5-220.7 °C
6.05 (20 °C)
1.659g/mL(20°C)
29.90 ug/mL (20 °C)
Solvent
/7-xylene
n-heptane
methanol
1 ,2-dichloroethane
acetone
ethyl acetate
1Q-4 Pa (25°C)

Solubility (g/L)
0.488
0.000835
26.0
8.12
102
29.4

Does not dissociate
4.2 (pH 5.9, 25°C)
204.4 nm (neutral methanol)
Reference
Product
Chemistry Review
of Flubendiamide
Technical.

-------
Appendix 3 - Toxicity Profiles
Acute Toxicity Profile - Flubendiamide
Guideline
No.
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute oral - rat
Acute dermal- rat
Acute inhalation - rat
Acute eye irritation -rabbit
Acute dermal irritation -
rabbit
Skin sensitization - guinea
Pig
MRID(s)
46817144
46817147
46817150
46817203
46817206
46817209
Results
LD50 = >2000
mg/kg
LD50 = >2000
mg/kg
LC50 = >0.0685
mg/L
Irritating (slight)
Non-irritating
Negative
Toxicity Category
III
III
III
IV
IV
N/A
Subchronic, Chronic and Other Toxicity Profile
Guideline No.
870.3050
870.3050
870.3050
870.3100
Study Type
28-Day Oral
(rat)
Not Submitted*
28-Day Oral
(mice)
Not Submitted*
28-Day oral
toxicity (dog)
Not Submitted*
90-Day oral
toxicity (rat)
MRID No. (year)/
Classification /Doses
ppm: 0 - 20 - 50 - 200 -
2000 - 20000
mg/kg/day:
M: 0-1.53 -3.88 -15.1
-52-1575
F:0-1.63-4.17-16.1-
156-1605
ppm:
0 - 20 - 200 - 2000 -
20000
mg/kg/day:
M: 0-2.73 -26.9 -265-
2678
F: 0-2.88 -30.0 -299-
3024
ppm:
0-40-400-4,000-
40,000
mg/kg/day:
M:0-l. 12-10.7-101-
1111
F: 0-1. 10 -12.0 -120-
1180
46817210(2003)/
Acceptable/guideline
ppm:
0 - 20 - 50 - 200 - 2000
- 20000
mg/kg/day:
M:0-l. 15-2.85-11.4
-116-1192
F: 0-1.30 -3.29 -13.1 -
128-1320
Results
NOAEL (M/F) =15.1/4.17 mg/kg/day
LOAEL (M/F) =152/16.1 mg/kg/day based
on: liver: t(m/f>- periportal fatty change, fwt
[abs/rel (m/f)]
i(f)-ALP
t(f>- GPT
NOAEL (M/F) = 26.9 / 30.0 mg/kg/day
LOAEL (M/F) = 265 / 299 mg/kg/day based
on: liver: ^(m/f)- hypertrophy (centrilobular
hepatocytes);t(m)-[dark-colored + fatty
change (centrilobular hepatocytes)]
NOAEL (M/F) =10.7/1.10 mg/kg/day
LOAEL (M/F) = 101 / 12.0 mg/kg/day based
on: t(m/f)- ALP
NOAEL (F) = 13.1 mg/kg/day
LOAEL (F) = 128 mg/kg/day based on: slight
hepatotoxicity (f(f) - periportal fatty change,
hepatocellular hypertrophy, twt [abs/rel(f)],
TGGT

-------
Subchronic, Chronic and Other Toxicity Profile
Guideline No.
870.3150
870.3150
870.3200
870.3700a
870.3700b
Study Type
90-Day oral
toxicity (mouse)
90-Day oral
toxicity (dog)
28/29-Day dermal
toxicity (rat)
Prenatal
developmental in
(rat)
Prenatal
developmental in
(rabbit)
MRID No. (year)/
Classification /Doses
46817211(2002)7
Acceptable/guideline
ppm:
0-50-100-1000-
10000
mg/kg/day:
M: 0-6.01 -11.9 -123-
1214
F: 0-7.13 -14.7 -145-
1424
46817212 and 46817242
(2003)/
Acceptable/guideline
ppm:
0-100-2000-40000
mg/kg/day:
M: 0-2.58 -52.7 -1076
F: 0-2.82 -59.7 -1135
46817213(2004)/
Acceptable/guideline
mg/kg/day:
0-10-100-1000
468 172 15 and 468 17241
(2003)/
Acceptable/guideline
mg/kg/day:
0-10-100-1000
468 172 14 and 468 17240
(2002)/
Acceptable/guideline
mg/kg/day:
0-10-100-1000
Results
NOAEL (M/F) = 1 1.9 / 14.7 mg/kg/day
LOAEL (M/F) =123/145 mg/kg/day based
on slight hepatotoxicity: (ffatty change,
hepatocellular hypertrophy, | abs/rel wt [f])
NOAEL (M/F) = 2.58 / 2.82 mg/kg/day
LOAEL (M/F) = 52.7 / 59.7 mg/kg/day based
on clinical signs of toxicity (loose stool),
shortened APTT, increased ALP and
triglycerides, increased adrenal weights, and
microscopic effects on the adrenal glands in
females:
adrenal: |(f) - cortical hypertrophy; f(f) - wt
i(m/f) - APTT
t - [ALP(m/f), Triglycerides(f)]
NOAEL = 100 mg/kg/day (systemic); 1000
mg/kg/day (local skin)
LOAEL = 1000 mg/kg/day based on:
liver: f(m/f)-periportal fatty change + fwt
[abs/rel]; thyroid: f(f)-follicular cell
hypertrophy
i(f) -[Hct + MCV + MCH]
4(f) - AST
Maternal: NOAEL = 10 mg/kg/day;
LOAEL = lOOmg/kg/day based on: liver:
twt[abs/rel].
Developmental: NOAEL >1000 mg/kg/day;
LOAEL was not observed (>1000
mg/kg/day).
Maternal: NOAEL= 100 mg/kg/day;
LOAEL = 1000 mg/kg/day based on: food
consumption decreaseon last day of treatment
(GD27-28) and loose stool
Developmental: NOAEL >1000 mg/kg/day;
LOAEL not observed (>1000 mg/kg/day)

-------
Subchronic, Chronic and Other Toxicity Profile
Guideline No.
   Study Type
   MRTO No. (year)/
  Classification /Doses
                 Results
870.3800
Two-generation
Reproduction and
fertility effects
(rat)
46817216(2004)7
Acceptable/guideline
ppm:
0 - 20 - 50 - 2000 -
20000
mg/kg/day (premating
doses):
Pm: 0-1.30-3.30-131
-1307
Pf: 0-1.59 -3.95 -159-
1577
Flm: 0-1.64-4.05-
162-1636
Flf: 0-1.84-4.59-176
-1808
Parental/Systemic: NOAEL (M/F) = 3.30 /
3.95 mg/kg/day; LOAEL (M/F) = 131/159
mg/kg bw/day based on: liver:  tP/Flm-
[brown pigment deposition + wt (rel)]; fPf
/Flf-[enlarged/dark-colored livers +
hepatocyte hypertrophy + periportal  fatty
change + brown pigment deposition  + wt];
thyroid: |P/F1 -[follicular cell hypertrophy];
twt (abs Pm); kidney: tPf-[tubular
basophilic change + urinary casts]; tPf /Flf—
wt; ovary: fPf -interstitial cell vacuolation;
uterus: |wt (Pf); pituitary: |.wt (Fl); spleen:
|wt(Pf/Flf)
Reproductive: No effect of treatment on:
precoital interval; mating, fertility, or
gestation indices; or gestation duration in
either generation. Furthermore, the numbers
of primordial ovarian follicles in the  20,000
ppm Fl  dams were comparable to controls.
No effects were noted on estrous cycle
duration or sperm parameters.  The NOAEL is
20,000 ppm (1307/1577 mg/kg/day
males/females, respectively). The LOAEL for
reproductive toxicity was not observed.
Offspring: NOAEL = 3.30 mg/kg/day;
LOAEL =131 mg/kg/day based on:  liver:  f-
[hepatocyte hypertrophy, diffuse fatty change,
brown pigment deposition, proliferation bile
ducts; wt]; thyroid: f follicular cell
hypertrophy; spleen + thymus:  |wt; feyeball
enlargement	
                One-generation
                reproduction study
                in rat
                    46817239
                    (2004)/Acceptable/nongui
                    deline
                    ppm:
                    0-50-200-2000-20,000
                    mg/kg/day:
                    Pm: 0-3.25-12.91-127.2-
                    1287
                    Pf: 0-3.84-14.97-148.9-
                    1490
                          Parental: LOAEL is 2000 ppm (127.2/148.9
                          mg/kg/day in amles/females, respectively)
                          bsed on effects on the liver, thyroid, and
                          kidneys. The NOAEL is 200 ppm
                          (12.91/14.97 mg/kg/day in males/females,
                          respectively).
                          Reproductive: The LOAEL was not observed
                          and the NOAEL is 20,000 ppm (1287/1490
                          mg/kg/day in males/females, respectively).
                          Offspring: The LOAEL is 2000 ppm
                          (127.2/148.9 mg/kg/day in males/females,
                          respectively) based on effects on the eyes and
                          liver; and on increased anogenital distance
                          and delayed sexual maturation in the males.
                          The NOAEL is 200 ppm (12.91/14.97
                          mg/kg/day in males/females, respectively).	

-------
Subchronic, Chronic and Other Toxicity Profile
Guideline No.


870.4100a
870.4 lOOb
870.4200a
870.4200b
Study Type
Histopathology of
the Eyes of
Weanlings in a
One-generation
Reproduction
Study in Rats
Perinatal Ocular
Toxicity Study in
CD-I Mice
following exposure
via diet
Chronic toxicity
(rat)
Chronic toxicity
(dog)
Carcinogenicity
(rat)
Carcinogenicity
(mouse)
MRTO No. (year)/
Classification /Doses
468 1 7238/Acceptable/non
-guideline
ppm:
0-50-200-2000-20,000
mg/kg/day:
Pm: 0-3.25-12.91-127.2-
1287
Pf: 0-3.84-14.97-148.9-
1490
46817236/ non-guideline
approx. 1000 mg/kg/day
from day 6 post
conception until lactation
day 21
46817217(2004)/
Acceptable/guideline
ppm:
0 - 20 - 50 - 2000 -
20000
mg/kg/day:
M: 0-0.8 -2.0 -79.3-
822
F: 0-1.0 -2.4 -97.5-
998
46817218
Acceptable/guideline
ppm:
0-100-1500-20000
mg/kg/day:
M: 0-2.21 -35.2 -484
F: 0-2.51 -37.9 -533
46817219(2004)/
Acceptable/guideline
ppm:
0-50-1000-20000
mg/kg/day:
M: 0-1.70 -33.9 -705
F: 0-2.15 -43.7 -912
4681 7220 (2004)/
Acceptable/guideline
ppm:
0-50-1000-10000
mg/kg/day:
M: 0-4.85 -94 -988
F: 0 - 4.44 - 93 - 937
Results
Offspring: The LOAEL for offspring toxicity
is 2000 ppm (127.2/148.9 mg/kg/day in
males/females, respectively) bsed on
confirmed microscopic effects on the eyes in
both sexes. The NOAEL is 200 ppm
(12.91/14.97 mg/kg/day in males/females,
respectively).
Eye lesions of viable pups were noted neither
during the lactation period nor during the
follow-up period lasting from PND 22-42.
Offspring: The LOAEL for offspring toxicity is
4500/2000 ppm (equivalent to 1052.3 mg/kg/day)
based on decreased pup body weights and body
weight gains. The NOAEL was not established.
NOAEL (F) = 2.4 mg/kg/day.
LOAEL (F) = 97.5 mg/kg/day based on:
hepatotoxicity (periportal fatty change,
hepatocyte hypertrophy, twt [abs/rel] and
tGGT
NOAEL (M/F) = 2.21 / 2.51 mg/kg/day.
LOAEL (M/F) = 35.2 / 37.9 mg/kg/day based
on: liver: twt [abs m+f, rel(m)]
|(m) - BWG and BW
i -[APTT(m/f),
t(m/f) - ALP
NOAEL (M/F) =1.70/2.15 mg/kg/day.
LOAEL (M/F) = 33.9 / 43.7 mg/kg/day based
on: liver: t(m/f)- [periportal fatty change,
hypertophy] ;f wt [abs/rel(m/f)]; kidney:
!(m/f)- chronic nephropathy; jwt [rel(f)]
No evidence of Carcinogenicity
NOAEL (M/F) = 4.85 / 4.44 mg/kg/day.
LOAEL (M/F) = 94/93 mg/kg/day based on:
hepatotoxicity (periportal fatty changes,
hypertophy); thyroid changes (ffollicular cell
hypertrophy with hydropic change, f large
sized follicles)
No evidence of Carcinogenicity

-------
Subchronic, Chronic and Other Toxiciry Profile
Guideline No.
870.5100
870.5100
870.5300
870.5375
870.5395
870.5395
870.6200a
870.6300
Study Type
Gene mutation
(in vitro bacteria)
Gene mutation
(in vitro bacteria)
Gene Mutation
(in vitro
mammalian V79)
Mammalian
Cytogenetics (in
vitro CHL)
Mammalian
Cytogenetics
(micronucleus
mouse)
Mammalian
Cytogenetics
(micronucleus
mouse)
Acute neurotoxicity
screening battery
Developmental
neurotoxicity
MRTO No. (year)/
Classification /Doses
46817221
Acceptable/guideline
0-3.86-11.6-34.7-
104-313
ug/plate (w/o activation)
0-61.7-185-556-
1,670-5,000
ug/plate (+ activation)
46817222
Unacceptable/guideline
0-16-50-158-500-
158 1-5000 ug/plate (+/-
S9 activation)
(conducted w/ NNI-0001
SC)
46817224
Acceptable/guideline
0-7.5-15-30-60-
120-240
ug/ml (+/ - activation)
Acceptable/guideline
0-550-1100-2200
ug/ml (+ activation)
0 -(125-550) - (250-
11 00) -(500-2200)
ug/ml; 6, 20, or 40 hrs
exp. (w/o activation)
46817226
Acceptable/guideline
0 - 1000 - 2000 - 4000
mg/kg
46817225
Acceptable/guideline
0-500-1000-2000
mg/kg
46817227
Acceptable/guideline
mg/kg/day:
0-209-731-2213
(analytically determined)
46817228
Acceptable/non-guideline
ppm:
0-120-1200-12000
ppm
mg/kg/day (based on last
2 wks of gestation
and 3 wks of lactation):
0 - 9.9 - 99.5 - 979.6
Results
Negative
Negative
Negative
Negative
Negative
Negative
NOAEL = 2213 mg/kg/day
LOAEL = Not observed (>2213 mg/kg/day)
Maternal: NOAEL = 9.9 mg/kg/day
LOAEL = 99.5 mg/kg/day based on: liver:
|wt[abs/rel].
Offspring: NOAEL = 9.9 mg/kg/day
LOAEL = 99.5 mg/kg/day based on
tbalanopreputial separation time: this LOAEL
is also protective of adverse eye effects
reported at 979.6 mg/kg/day (eye - [enlarged
eyeball + exophthalamus + general ocular
opacity(m)])

-------
Subchronic, Chronic and Other Toxicity Profile
Guideline No.
870.7485
870.7600
870.7800



Study Type
Metabolism and
pharmacokinetic s
-rat
Dermal penetration
(monkey)
4-week
Immunotoxicity
(plaque-forming
assay in rat)
Effects on Thyroid
Hormones and
Liver Enzymes in
Female Rats
In vitro
Metabolism in rat,
mouse, dog and
human microsomes
Toxicokinetic study
in rats and mouse
MRTO No. (year)/
Classification /Doses
468 17229, 468 17230 and
46817231
Acceptable/guideline
46817234
Acceptable/non-guideline
46817243
Acceptable/guideline
ppm:
0-40-400-4000
mg/kg/day:
M: 0-3.34 -33.6 -336.3
F: 0-4.0 -38.4 -358.8
46817235
Acceptable/non-guideline
ppm:
0-1000-10,000
mg/kg/day:
0-83-812
46817232
Acceptable/Non-guideline
46817233
Acceptable/Non-guideline
Results
Oral absorption = 23.5/34.1% in m/f,
respectively (average = 29%); see Section 3.2
Appendix A. 3 for more information
Intravenous injection of [14CJNNI-
0001 resulted in excretion of a large fraction of
the dosed radioactivity in feces. Total
recoveries through 360 hours post-dose were
80.91% in feces, 7.78% in urine, and 4.1 1% in
cage debris/rinse samples. Dermal application
of [14C]NNI-0001 resulted in a negligible
absorption of 0.02% at 8 hrs post-dose. The
overall mean total recovery of radioactivity
from excreta and from the application site was
105.15%, the majority of which was
associated with the radioactivity recovered
from the application site.
NOAEL (M/F) = 336/358.8 mg/kg/day.
No evidence of primary immunotoxicity
Study generally support this indirect effect on
the thyroid via induction of enzymes in the
liver. Direct effects on the liver included
increases in organ weights, cytochrome P450,
UDP-GT and EROD activities, and incidences
of hepatocyte hypertrophy and vacuolation.
see Appendix A. 3 for more information
see Appendix A.3 for more information
The studies designated as "Not Submitted" were included in the registrant's toxicity profile table, which
in turn was in the registrant's human health risk assessment (MRID 46817252, p. 42); there are reported
here in order to be as thorough, complete and inclusive as possible.

-------
Appendix 4 - Ecological Effects Data
Ecological Effects Data Requirements for Flubendiamide
Guideline #
71-1
71-2
71-4
72-1
72-2
72-3(a)
72-
3(b)
72-3(c)
72-4(a)
72-
4(b)


72-5
122-
l(a)

122-
l(b)
122-2
122-2
850.2100
850.2200
850.2300
850.1075
850.1010
850.1075
850.1025
850.1035
850.1045
850.1400
850.1300
850.1350
850.1300
850.1790

850.1500
850.4100

850.4150
850.4400
850.4400
Data Requirement
Avian Oral LD50
Avian Dietary LCso
Avian Reproduction
Freshwater Fish LC50
Freshwater
Invertebrate LC50
Estuarine/Marine
Fish LC50
Estuarine/Marine
Mollusk EC50
Estuarine/Marine
Shrimp LC50
Freshwater Fish
Early Life Stage
Aquatic Invertebrate
Life-cycle
Benthic Organisms
Mesocosm Study
Freshwater Fish
Life-Cycle
Seed Germination/
Seedling Emergence
Tierl
Herbicidal Toxicity
Terrestrial plants
Tier 2
Vegetative Vigor
Tierl
Aquatic Plant (Non-
Vascular)
Tier l&II
Aquatic Plant
(Vascular)
Tier 2
Formulation
Technical
480 SC
Technical
Technical
Technical
Technical
Technical
Technical
Technical
Technical
480 SC
480 SC
Technical
24 WG
480 SC
480 SC
Des-iodo
Technical
Technical
Technical
Technical
Technical
Technical
480 SC
Technical
24 WG
480 SC
Des-iodo
480 SC
Technical
24 WG
480 SC
480 SC
Technical
24 WG
Technical
480 SC
Technical
MRID (Accession #)
46817003
46817004
46817005
46817006
46817007
46817008
46816937
46816939
46816940
46816941
46816942
46816943
46816930
46816932
46816931
46816934
46816933
46816938
46816935
46816936
46816947
46816944
46816946
46816945
46817022
46817014
46817013
46817023
46817002
46816948
46817034
46817036(a)
46817035
46817036(b)
46817037
46817041
46817040
46817039
Study Classification
Acceptable
Acceptable
Acceptable
Acceptable
Supplemental
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Supplemental
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Supplemental
Acceptable
Acceptable
Supplemental
Acceptable
Acceptable
Supplemental
Supplemental
Unacceptable
Acceptable
Acceptable
Supplemental, Non-
guideline
Acceptable
Supplemental
Acceptable
Acceptable
Acceptable

-------
Ecological Effects Data Requirements for Flubendiamide
Guideline #
123-
l(a)

141-1









141-2

















850.4225


850.3020




850.6200


850.6200

850.3030

















Data Requirement
Seed Germination/
Seedling Emergence
Tier 2
Honey Bee Acute
Contact LD50



Acute Toxicity to
Earthworms

Chronic Toxicity to
Earthworms
Honey Bee Residue
on Foliage
Parasitoid Wasp

Predatory Mite

Ladybird Beetle
(45 day study)
Ladybird Beetle
(Extended Study)
Ladybird Beetle
(Life Cycle Test)
Parasitic Wasp
(Side Effects Tests)
White springtail
(Reproduction Test)
Green lacewing
(Extended Study)
Formulation
24 WG


Technical
480 SC
480 SC
WG40

Technical
480 SC
Des-iodo
480 SC
24 WG
NA

WG40

WG40

480 SC

480 SC

480 SC

480 SC

480 SC

480 SC

MRID (Accession #)
46817038


46817009
46817010
46817011
46817012

46817028
46817029
46817030
46817031
46817032
NA

46817020

46817019

46817015

46817016

46817017

46817021

46817027

46817018

Study Classification
Acceptable


Acceptable
Acceptable
Acceptable
Supplemental, Non-
guideline
Supplemental
Supplemental
Supplemental
Supplemental
Supplemental
NA

Supplemental, Non-
guideline
Supplemental, Non-
guideline
Supplemental, Non-
guideline
Supplemental, Non-
guideline
Supplemental, Non-
guideline
Supplemental, Non-
guideline
Supplemental

Supplemental


-------
Appendix 5 - Environmental Fate Data
Environmental Fate Data Requirements for Flubendiamide
Guideline #
161-1
161-2
161-3
161-4
162-1
162-2
162-3
162-4
163-1
163-2
163-3
164-1
165-4

835.212
835.224
835.241
835.237
835.41
835.42
835.44
835.43
835.1240
835.1230
835.141
835.81
835.61
850.173

Data Requirement
Hydrolysis
Photodegradation in Water
Photodegradation on Soil
Photodegradation in Air
Aerobic Soil Metabolism
Anaerobic Soil
Metabolism
Anaerobic Aquatic
Metabolism
Aerobic Aquatic
Metabolism
Leaching-
Adsorption/Desorption
Laboratory Volatility
Field Volatility
Terrestrial Field
Dissipation
Accumulation in Fish
Quantum Yield in Water
MRID#s
46816907
46816908
46816909
NA'
Parent: 46816910
Degradate:46816911
46816912
46816914
46816913
Parent: 468 16905
Degradate: 468 16906
NA
NA
46816915
46816916
46816917
46816949
46817001
46816919
Study
Classification
Acceptable
Acceptable
Acceptable
NA
Acceptable
Acceptable
Supplemental
Acceptable
Acceptable
Supplemental
Supplemental
NA
NA
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Supplemental
1 Not Available.

-------
Appendix 6 - Bibliography

71-2    Avian Dietary Toxicity
    MRID
                                     Citation Reference
46817005      Bowers, L. (2005) Technical NNI 0001: A Subacute Dietary LC50 with
              Mallards. Project Number: AS720801, 201263. Unpublished study
              prepared by Bayer Corp. 41  p.
71-4    Avian Reproduction
   MRID                            Citation Reference
46817007
46817008
              Sabbert, T. (2004) Effect of Technical NNI 0001 on Mallard
              Reproduction. Project Number: EBAM0221. Unpublished study
              prepared by Bayer Corp. 114 p.
              Bowers, L. (2005) Effect of Technical NNI 0001 on Northern Bobwhite
              Reproduction. Project Number: AS741701, 201138. Unpublished study
              prepared by Bayer Corp. 143 p.
72-1    Acute Toxicity to Freshwater Fish
    MRID                            Citation Reference
46816937      Kern, M; DeHann, R. (2004) Acute Toxicity of NNI 0001 Technical to
              the Fathead Minnow (Pimephales promelas) Under Static Conditions.
              Project Number: EBAM0390/AS811201, 200713. Unpublished study
              prepared by Bayer Corp. 42 p.

46816939      Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 (Tech.) to Fish
              (Lepomis macrochirus). Project Number: E/280/2291/4, DOM/22043.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 49 p.

46816940      Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 (Tech.) to Fish
              (Oncorhynchus mykiss). Project Number: DOM/22044, E/280/2292/5.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 75 p.

46816942      Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 480 SC to Fish
              (Lepomis macrochirus). Project Number: E/280/2352/2, DOM/22081,
              00789. Unpublished study prepared by Bayer Ag, Institute of Product
              Info. & Residue Anal. 42 p.

46816943      Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 480 SC to Fish
              (Oncorhynchus mykiss). Project Number: E/280/2354/4, DOM/22082,
              00789. Unpublished study prepared by Bayer Ag, Institute of Product

-------
              Info. & Residue Anal. 42 p.
72-2    Acute Toxicity to Freshwater Invertebrates
    MRID                            Citation Reference
46816930
46816931
46816932
46816933
46816934
              Dorgerloh, M. (2006) Acute Toxicity of NNI-0001 (tech.) in Water Fleas
              (Daphnia magna). Project Number: DOM/22041, E/320/2283/0,
              MR/391/02. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 39 p.

              Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 SC 480 to Water
              Fleas (Daphnia magna). Project Number: E/320/2284/1, DOM/22042.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 43 p.

              Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 WG 24 to the
              Waterflea Daphnia magna in a Static Laboratory Test System. Project
              Number: P/684/027017, MR/188/02, EBAMX018. Unpublished study
              prepared by Bayer Ag,  Institute of Product Info. & Residue Anal. 58 p.

              Dorgerloh, M. (2004) Acute Toxicity of NNI-0001-des-iodo to the
              Waterflea Daphnia magna. Project Number: DOM/23055, MR/029/04,
              E/320/2503/5. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 43 p.
              Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 SC 480 in the
              Waterflea Dahnia magna Under Different Feeding Conditions in a Static
              Laboratory Test System. Project Number: E/320/2849/8, EBAMX028,
              MR/188/02. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 59 p.
72-3    Acute Toxicity to Estuarine/Marine Organisms
    MRID                            Citation Reference
4681693 5      Dionne, E. (2004) NNI-0001 -Acute Toxicity to Eastern Oysters
              (Crassostrea Virginia) Under Flow-Through Conditions. Project Number:
              AS881501, 13798/613, EBAM0380. Unpublished study prepared by
              Springborn Smithers Laboratories. 53 p.

46816936      Dionne, E. (2004) NNI-0001 - Acute Toxicity to Mysids (Americamysis
              bahia) Under Static Conditions. Project Number: 13798/6131,
              AS883101, EBAMO376. Unpublished study prepared by Springborn
              Smithers Laboratories. 49 p.

46816938      Banman, C.; Kern, M.; Lam, C. (2004) Acute Toxicity of NNI 0001
              Technical to the Sheepshead Minnow (Cyprinodon variegatus) Under
              Static Conditions. Project Number: 200992, EBAM0370. Unpublished

-------
              study prepared by Bayer Corp. 31 p.
72-4    Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study
    MRID                            Citation Reference
46816944      Dorgerloh, M. (2003) Influence of NNI-0001 (Tech.) on Development
              and Reproductive Output of the Waterflea Daphnia magna in a Static
              Renewal Laboratory Test System. Project Number: E/321/2267/3,
              DOM/22035, 00760. Unpublished study prepared by Bayer Ag, Institute
              of Product Info. & Residue Anal. 88 p.

46816945      Dorgerloh, M. (2003) Influence of NNI-0001 SC 480 on Development
              and Reproductive Output of the Waterflea Daphnia magna in a Static
              Renewal Laboratory Test System. Project Number: E/321/2372/0,
              DOM/23001, 00760. Unpublished study prepared by Bayer Ag, Institute
              of Product Info. & Residue Anal. 81 p.

46816946      Putt, A. (2005) NNI-0001 - Life-Cycle Toxicity Test with Mysids
              (Americamysis bahia). Project Number: 13798/6156, EBAMO377.
              Unpublished study prepared by Springborn Smithers Laboratories. 89 p.

46816947      Kern, M; Lam, C. (2004) Early Life Stage Toxicity of NNI 0001
              Technical to the Fathead Minnow (Pimephales promelas) Under Flow-
              Through Conditions. Project Number: EBAMX005, 200995, AS841201.
              Unpublished study prepared by Bayer Corp. 86 p.
72-5    Life cycle fish
   MRID                            Citation Reference
46816948      Cafarella, M. (2005) NNI-0001 - The Full Life-Cycle Toxicity Test with
              Fathead Minnow (Pimphales promelas). Project Number: 13798/6155,
              EBAM0393. Unpublished study prepared by Springborn Smithers
              Laboratories. 141 p.
72-6    Aquatic org. accumulation
   MRID                            Citation Reference
46816949      Dorgerloh, M.; Weber, E. (2005) (Carbon 14)-NNI-0001-
              Bioconcentration and Biotransformation in Fish (Lepomis macrochirus).
              Project Number: DOM/23026, E/244/2330/8. Unpublished study
              prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 156 p.
122-1   Seed Germination/Seedline Emergence and Vegetable Vigor
   MRID                            Citation Reference

-------
46817036      Christ, M.; Lam, C. (2005) Tier I Seedling Emergence and Vegetative
              Vigor: Nontarget Phytotoxicity Study Using NNI-0001 480SC. Project
              Number: 201376, EBAMX007, EBAM0367. Unpublished study
              prepared by Bayer Corp. 62 p.
123-1    Seed germination/seedling emergence and vegitative vigor
   M RID                            Citation Reference
46817038      Christ, M.; Lam, C. (2006) Tier II Seedling Emergence: Nontarget
              Phytotoxicity Study using NNI-0001 WG24. Project Number:
              EBAMX049. Unpublished study prepared by Bayer Corp. 32 p.
123-2   Aquatic plant growth
   MRID                            Citation Reference
46817039      Kern, M.; Banman, C.; Lam, C. (2004) Toxicity of NNI 0001 Techncial
              to Duckweed (Lemna gibba G3) Under Static-Renewal Conditions.
              Project Number: EBAMX010, AS883701, 200604. Unpublished study
              prepared by Bayer Corp. 41 p.
132-1   Dissipation of Dislodgeable Foliar & Soil Residues
   MRID                           Citation Reference
46817245      Fischer, D. (2006) NNI-0001 480 SC - Dislodgeable Foliar Residue on
              Sweet Corn and Grape Plant Foliage: Final Report. Project Number:
              RAAMY004, AM001/05DA, AM002/05D. Unpublished study prepared
              by Bayer Corp. 494 p.
161-1    Hydrolysis
   MRID                           Citation Reference
46816907      Yamashita, A. (2001) Hydrolysis Study of NNI-0001: Final Report.
              Project Number: LSRC/A01/078A, GC/03, 01/0034. Unpublished study
              prepared by Nihon Nohyaku Co., Ltd. 56 p.
161-2   Photodegradation-water
   MRID                           Citation Reference
46816908      Motoba, K. (2005) Study on Aqueous Photolysis of NNI-0001:  Final
              Report (Amended II). Project Number: GC/03, LSRC/A01/128A,
              01/0036. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 88 p.

-------
161-3    Photodegradation-soil
    MRID                            Citation Reference
46816909      Shepler, K. (2004) Photodegradation of [(Carbon 14)]NNI-0001 in/on
              Soil by Artificial Light. Project Number: 1050W/1, 1050W. Unpublished
              study prepared by PTRL West, Inc. 141 p.
162-1   Aerobic soil metabolism
   MRID                            Citation Reference
46816910      Babczinski, P.; Eberhardt, R. (2004) NNI-0001: Aerobic Soil
              Degradation/Metabolism in Four Different Soils. Project Number:
              MEF/04/280, M1251206/7, M/125/1206/7. Unpublished study prepared
              by Bayer Ag, Institute of Product Info. & Residue Anal. 123 p.

46816911      Fliege, R. (2004) [Phthalic Acid Ring-UL-(Carbon 14)]-and [Aniline
              Ring-UL-(Carbon 14)]-NNI-0001-des-iodo: Aerobic Soil Metabolism in
              Four Soils. Project Number: M1251289/8, MEF/04/388, M/125/1289/5.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 114 p.
162-2   Anaerobic soil metabolism
   MRID                            Citation Reference
46816912      Hellpointner, E. (2004) Anaerobic Degradation/Metabolism of NNI-
              0001 in Soil. Project Number: M1261225/9, MEF/04/067,
              M/l 26/1225/9. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 56 p.
162-3    Anaerobic aquatic metab.
   MRID                            Citation Reference
46816914     Mathew, A. (2005) [Phthalic Acid Ring-UL-(Carbon 14)]NNI-0001:
              Anaerobic Aquatic Metabolism. Project Number: AS042401,
              MEAM6026. Unpublished study prepared by Bayer Corp. 72 p.
163-1    Leach/adsorp/desorption
   MRID                            Citation Reference
46816905      Babczinski, P.; Heinemann, O. (2004) Adsorption/Desorption of NNI-
              0001 on Soils. Project Number: M1311243/5, MR/201/03,
              M/l31/1243/5. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 75 p.

-------
46816906     Volkel, W. (2005) Adsoprtion/Desorption of [(Carbon 14)]-NNI-001-
              DES-IODO on Soils. Project Number: 855843. Unpublished study
              prepared by RCC Umweltchemie Ag. 108 p.
164-1    Terrestrial field dissipation
    MRID                            Citation Reference
46816916     Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in Mississippi
              Soil, 2003. Project Number: 03EFAMY002, AS022102,
              AM/001/S04/01. Unpublished study prepared by Bayer Corp., A & L
              Great Lakes Laboratories and Bayer CropScience Mississippi Field
              Station. 186 p.

46816917     Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in Washington
              Soil, 2003. Project Number: 03EFAMY003, AS022103,
              AM/001/S04/01. Unpublished study prepared by Bayer Corp., A & L
              Great Lakes Laboratories and Agvise Inc. 192 p.
165-4    Bioaccumulation in fish
   MRID                            Citation Reference
46816949     Dorgerloh, M; Weber, E. (2005) (Carbon 14)-NNI-0001-
              Bioconcentration and Biotransformation in Fish (Lepomis macrochirus).
              Project Number: DOM/23026, E/244/2330/8. Unpublished study
              prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 156 p.
171-11    Tobacco Uses: Total Residues and Pyrolysis Products
    MRID                            Citation Reference
46817244     Ponte, M.; Schick, M. (2006) Tobacco Pyrolysis of [14-Carbon]NNI-
              0001. Project Number: 1426W/1, 1426W, RAAMX049. Unpublished
              study prepared by PTRL West, Inc. 94 p.
830.1550    Product Identity and composition
    MRID                            Citation Reference
46816901      Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project
              Number: BR/2485, VB1/2005/0013501, ANR/07406. Unpublished study
              prepared by Bayer Corp and Bayer Ag,  Institute of Product Info. &
              Residue Anal. 474 p.

46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &

-------
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.

46816904      Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project
              Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p.
830.1600    Description of materials used to produce the product
   MRID                            Citation Reference
46816901      Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project
              Number: BR/2485, VB1/2005/0013501, ANR/07406. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal. 474 p.

46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.

46816904      Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project
              Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p.
830.1620    Description of production process
   MRID                            Citation Reference
46816901      Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project
              Number: BR/2485, VB 1/2005/0013501, ANR/07406. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal. 474 p.

46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.
830.1650    Description of formulation process
    MRID                            Citation Reference
46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.

-------
46816904      Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project
              Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p.
830.1670    Discussion of formation of impurities
   MRID                            Citation Reference
46816901      Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Proj ect
              Number: BR/2485, VB1/2005/0013501, ANR/07406. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal. 474 p.

46816903      Frank, J. (2006) Product Chemistry of NNI-001  480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.

46816904      Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project
              Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p.
830.1700    Preliminary analysis
   MRID                            Citation Reference
46816901      Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project
              Number: BR/2485, VB 1/2005/0013501, ANR/07406. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal. 474 p.
830.1750    Certified limits
    MRID                            Citation Reference
46816901      Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project
              Number: BR/2485, VB 1/2005/0013501, ANR/07406. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal. 474 p.

46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806,14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.

46816904      Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project
              Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study

-------
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p.
830.1800    Enforcement analytical method
   MRID                            Citation Reference
46816901      Fontaine, L. (2006) Product Chemistry of NNI-0001 Technical. Project
              Number: BR/2485, VB1/2005/0013501, ANR/07406. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal. 474 p.

46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.

46816904      Frank, J. (2006) Product Chemistry of NNI-0001 24 WG. Project
              Number: ANR/06406, ANR/06606, ANR/06706. Unpublished study
              prepared by Bayer Corp and Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 155 p.
830.6302    Color
   M RID                            Citation Reference
46816902      Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.

46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.
830.6303    Physical state
   MRID                            Citation Reference
46816902     Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.

46816903     Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.

-------
830.6304
   MRID
Odor
                         Citation Reference
46816902
46816903
830.6313
metal ions
    MRID
  Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
  Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
  Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
  Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.

  Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
  Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
  study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
  Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.
Stability to sunlight, normal and elevated temperatures, metals, and

                         Citation Reference
46816902      Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.
830.6314    Oxidizing or reducing action
    MRID                            Citation Reference
46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.
830.6315    Flammability
    MRID                            Citation Reference
46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.
830.6316    Explodability
   MRID                            Citation Reference
46816902     Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.

-------
               Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
               Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.
830.6317    Storage stability of product
    MRID                           Citation Reference
46816903      Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
               Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
               study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
               Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.
830.6320    Corrosion characteristics
    MRID                            Citation Reference
46816903     Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut  fuer Ruckstands-Analytik. 93 p.
830.7000    pH of water solutions or suspensions
   MRID                            Citation Reference
46816902     Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.

46816903     Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut  fuer Ruckstands-Analytik. 93 p.
830.7050    UV/Visible absorption
    MRID                            Citation Reference
46816902      Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.
830.7100    Viscosity
   MRID                            Citation Reference

-------
46816903     Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.
830.7200    Melting point/melting range
   MRID                            Citation Reference
46816902     Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.
830.7300    Density/relative density
    MRID                            Citation Reference
46816902     Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.

46816903     Frank, J. (2006) Product Chemistry of NNI-001 480 SC. Project
              Number: ANR/05806, 14/1050/5280, 2001/0054102/02E. Unpublished
              study prepared by Bayer Corp, Bayer Ag, Institute of Product Info. &
              Residue Anal, and Bayer Ag Institut fuer Ruckstands-Analytik. 93 p.
830.7370    Dissociation constant in water
   MRID                            Citation Reference
46816902      Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.
830.7560    Partition coefficient (n-octanol/water), generator column method
   MRID                            Citation Reference
46816902      Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.
830.7840    Water solubility: Column elution method, shake flask method
   MRID                            Citation Reference

-------
46816902     Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.
830.7950    Vapor pressure
    MRID                            Citation Reference
46816902     Folsom, B. (2005) Product Chemistry of NNI-0001 Technical: (Final
              Report). Project Number: 608/58, GE/03/01/0008, LSRC/A01/012A.
              Unpublished study prepared by Bayer Corp, Bayer Ag, Institute of
              Product Info. & Residue Anal, and Covance Laboratories, Ltd. 287 p.
835.1240    Soil column leaching
    MRID                            Citation Reference
46816906     Volkel, W. (2005) Adsoprtion/Desorption of [(Carbon 14)]-NNI-001 -
              DES-IODO on Soils. Project Number: 855843. Unpublished study
              prepared by RCC Umweltchemie Ag. 108 p.
835.2120    Hydrolysis of parent and degradates as a function of pH at 25 C
   MRID                            Citation Reference
46816907      Yamashita, A. (2001) Hydrolysis Study of NNI-0001: Final Report.
              Project Number: LSRC/A01/078A, GC/03, 01/0034. Unpublished study
              prepared by Nihon Nohyaku Co., Ltd. 56 p.
835.2240    Direct photolysis rate of parent and degradates in water
    MRID                            Citation Reference
46816908      Motoba, K. (2005) Study on Aqueous Photolysis of NNI-0001: Final
              Report (Amended II). Project Number: GC/03, LSRC/A01/128A,
              01/0036. Unpublished study prepared by Nihon Nohyaku Co., Ltd. 88 p.
835.2410    Photodegradation of parent and degradates in soil
   MRID                            Citation Reference
46816909      Shepler, K. (2004) Photodegradation of [(Carbon 14)]NNI-0001 in/on
              Soil by Artificial Light. Project Number: 1050W/1, 1050W. Unpublished
              study prepared by PTRL West, Inc. 141 p.

-------
835.4100
    MRID
Aerobic soil metabolism
                         Citation Reference
46816910      Babczinski, P.; Eberhardt, R. (2004) NNI-0001: Aerobic Soil
               Degradation/Metabolism in Four Different Soils. Project Number:
               MEF/04/280, Ml251206/7, M/l25/1206/7. Unpublished study prepared
               by Bayer Ag, Institute of Product Info. & Residue Anal. 123 p.

46816911      Fliege, R. (2004) [Phthalic Acid Ring-UL-(Carbon 14)]-and [Aniline
               Ring-UL-(Carbon 14)]-NNI-0001-des-iodo: Aerobic Soil Metabolism in
               Four Soils. Project Number: M1251289/8, MEF/04/388, M/125/1289/5.
               Unpublished study prepared by Bayer Ag, Institute of Product Info. &
               Residue Anal. 114 p.
835.4200    Anaerobic soil metabolism
    MRID                            Citation Reference
46816912      Hellpointner, E. (2004) Anaerobic Degradation/Metabolism of NNI-
               0001 in Soil. Project Number: M1261225/9, MEF/04/067,
               M/126/1225/9. Unpublished study prepared by Bayer Ag, Institute of
               Product Info. & Residue Anal. 56 p.
835.4300    Aerobic aquatic metabolism
   MRID                             Citation Reference
46816913      Sneikus, J. (2004) Aerobic Degradation and Metabolism of NNI-0001 in
               the Water/Sediment System. Project Number: Ml511248/2,
               MEF/414/03, M/151/1248/2. Unpublished study prepared by Bayer Ag,
               Institute of Product Info. & Residue Anal. 91 p.
835.4400    Anaerobic aquatic metabolism
    MRID                            Citation Reference
46816914     Mathew, A. (2005) [Phthalic Acid Ring-UL-(Carbon 14)]NNI-0001:
              Anaerobic Aquatic Metabolism. Project Number: AS042401,
              MEAM6026. Unpublished study prepared by Bayer Corp. 72 p.
835.6100    Terrestrial field dissipation
    MRID                            Citation Reference
46816915      Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in California
              Soil, 2003. Project Number: 03EFAMY001, AS022101. Unpublished
              study prepared by Bayer Corp., A & L Great Lakes Laboratories and

-------
               Bayer CropScience. 187 p.

46816916      Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in Mississippi
               Soil, 2003. Project Number: 03EFAMY002, AS022102,
               AM/001/S04/01. Unpublished study prepared by Bayer Corp., A & L
               Great Lakes Laboratories and Bayer CropScience Mississippi Field
               Station. 186 p.

46816917      Lee, R. (2006) Terrestrial Field Dissipation of NNI-0001 in Washington
               Soil, 2003. Project Number: 03EFAMY003, AS022103,
               AM/001/S04/01. Unpublished study prepared by Bayer Corp., A & L
               Great Lakes Laboratories and Agvise Inc. 192 p.
835.6200    Aquatic field dissipation
    MRID                            Citation Reference
46817033      Sommer, H. (2002) Method for the Determination of NNI-0001 in Test
               Water from Aquatic Toxicity Test by HPLC-UV. Project Number:
               MR/391/02, 00789. Unpublished study prepared by Bayer Ag, Institute
               of Product Info. & Residue Anal. 12 p.
850.1010    Aquatic invertebrate acute toxicity, test, freshwater daphnids
   MRID                           Citation Reference
46816930     Dorgerloh, M. (2006) Acute Toxicity of NNI-0001 (tech.) in Water Fleas
              (Daphnia magna). Project Number: DOM/22041, E/320/2283/0,
              MR/391/02. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 39 p.

46816931     Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 SC 480 to Water
              Fleas (Daphnia magna). Project Number: E/320/2284/1, DOM/22042.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 43 p.

46816932     Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 WG 24 to the
              Waterflea Daphnia magna in a Static Laboratory Test System. Project
              Number: P/684/027017, MR/188/02, EBAMX018. Unpublished study
              prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 58 p.

46816933     Dorgerloh, M. (2004) Acute Toxicity of NNI-0001-des-iodo to the
              Waterflea Daphnia magna. Project Number: DOM/23055, MR/029/04,
              E/3 20/2503/5. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 43 p.

46816934     Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 SC 480 in the
              Waterflea Dahnia magna  Under Different Feeding Conditions in a Static
              Laboratory Test System. Project Number: E/320/2849/8, EBAMX028,

-------
              MR/188/02. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 59 p.
850.1025    Oyster acute toxicity test (shell deposition)
    MRID                            Citation Reference
4681693 5     Dionne, E. (2004) NNI-0001 -Acute Toxicity to Eastern Oysters
              (Crassostrea Virginia) Under Flow-Through Conditions. Project Number:
              AS881501, 13798/613, EBAM0380. Unpublished study prepared by
              Springborn Smithers Laboratories. 53 p.
850.1035    Mysid acute toxicity test
   MRID                            Citation Reference
46816936     Dionne, E. (2004) NNI-0001 - Acute Toxicity to Mysids (Americamysis
              bahia) Under Static Conditions. Project Number: 13798/6131,
              AS883101, EBAMO376. Unpublished study prepared by Springborn
              Smithers Laboratories. 49 p.
850.1075    Fish acute toxicity test, freshwater and marine
   MRID                            Citation Reference
46816937     Kern, M; DeHann, R. (2004) Acute Toxicity of NNI 0001 Technical to
              the Fathead Minnow (Pimephales promelas) Under Static Conditions.
              Project Number: EBAM0390/AS811201, 200713. Unpublished study
              prepared by Bayer Corp. 42 p.

46816938     Banman, C.; Kern, M.; Lam, C. (2004) Acute Toxicity of NNI 0001
              Technical to the Sheepshead Minnow (Cyprinodon variegatus) Under
              Static Conditions. Project Number: 200992, EBAM0370. Unpublished
              study prepared by Bayer Corp. 31 p.

46816939     Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 (Tech.) to Fish
              (Lepomis macrochirus). Project Number: E/280/2291/4, DOM/22043.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 49 p.

46816940     Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 (Tech.) to Fish
              (Oncorhynchus mykiss). Project Number: DOM/22044, E/280/2292/5.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 75 p.

46816941     Yamazaki, I. (2003) Acute Toxicity Test of NNI-0001 to Carp. Project
              Number: GC/01, LSRC/T02/126A, 02/0145. Unpublished study
              prepared by Nihon Nohyaku Co., Ltd. 30 p.

-------
46816942     Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 480 SC to Fish
              (Lepomis macrochirus). Project Number: E/280/2352/2, DOM/22081,
              00789. Unpublished study prepared by Bayer Ag, Institute of Product
              Info. & Residue Anal. 42 p.

46816943     Dorgerloh, M. (2003) Acute Toxicity of NNI-0001 480 SC to Fish
              (Oncorhynchus mykiss). Project Number: E/280/2354/4, DOM/22082,
              00789. Unpublished study prepared by Bayer Ag, Institute of Product
              Info. & Residue Anal. 42 p.
850.1300    Daphnid chronic toxicity test
    MRID                            Citation Reference
46816944     Dorgerloh, M. (2003) Influence of NNI-0001 (Tech.) on Development
              and Reproductive Output of the Waterflea Daphnia magna in a Static
              Renewal Laboratory Test System. Project Number: E/321/2267/3,
              DOM/22035, 00760. Unpublished study prepared by Bayer Ag, Institute
              of Product Info. & Residue Anal. 88 p.

46816945     Dorgerloh, M. (2003) Influence of NNI-0001 SC 480 on Development
              and Reproductive Output of the Waterflea Daphnia magna in a Static
              Renewal Laboratory Test System. Project Number: E/321/2372/0,
              DOM/23001, 00760. Unpublished study prepared by Bayer Ag, Institute
              of Product Info. & Residue Anal. 81 p.
850.1400    Fish early-life stage toxicity test
   MRID                            Citation Reference
46816946     Putt, A. (2005) NNI-0001 - Life-Cycle Toxicity Test with Mysids
              (Americamysis bahia). Project Number: 13798/6156, EBAMO377.
              Unpublished study prepared by Springborn Smithers Laboratories. 89 p.

46816947     Kern, M; Lam, C. (2004) Early Life Stage Toxicity of NNI 0001
              Technical to the Fathead Minnow (Pimephales promelas) Under Flow-
              Through Conditions. Project Number: EBAMX005, 200995, AS841201.
              Unpublished study prepared by Bayer Corp. 86 p.
850.1500    Fish life cycle toxicity
   MRID                            Citation Reference
46816948      Cafarella, M. (2005) NNI-0001 - The Full Life-Cycle Toxicity Test with
              Fathead Minnow (Pimphales promelas). Project Number: 13798/6155,
              EBAM0393. Unpublished study prepared by Springborn Smithers
              Laboratories. 141 p.

-------
850.1730
    MRID
Fish BCF
                          Citation Reference
46816949      Dorgerloh, M; Weber, E. (2005) (Carbon 14)-NNI-0001-
               Bioconcentration and Biotransformation in Fish (Lepomis macrochirus).
               Project Number: DOM/23026, E/244/2330/8. Unpublished study
               prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 156 p.
850.1850    Aquatic food chain transfer
    MRID                           Citation Reference
46817001      Weber, E.; Dorgerloh, M. (2005) [Aniline-UL-(Carbon 14)]-NNL-0001-
               desidio: Bioconcentration, Depuration and Determination of Residues in
               Fish (Lepomis macrochirus). Project Number: DOM/24023,
               E/244/2683/9. Unpublished study prepared by Bayer Ag, Institute of
               Product Info. & Residue Anal. 111 p.
850.1950    Field testing for aquatic organisms
    MRID                           Citation Reference
46817002      Heimbach, F.; Arnold, M.; Brumhard, B. (2005) Biological Effects and
               Fate of NNI-0001 SC 480 in Outdoor Mesocosm Ponds. Project
               Number: HBF/BT/06, E/413/2434/1. Unpublished study prepared by
               Bayer Ag, Institute of Product Info. & Residue Anal, and Fraunhofer
               Institute for Molecular. 349 p.
850.2100    Avian acute oral toxicity test
    MRID                            Citation Reference
46817003     Barfknecht, R. (2003) Acute Oral Toxicity for Northern Bobwhite Quail
              (Colinus virginianus): NNI-0001. Project Number: E/204/2295/4,
              BAR/LD/044. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 32 p.

46817004     Barfknect, R. (2004) Acute Oral Toxicity for Bobwhite Quail (Colinus
              virginianus): NNI-0001 SC 480. Project Number: E/204/2717/3,
              BAR/LD/057. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 24 p.
850.2200    Avian dietary toxicity test
   MRID                            Citation Reference
46817005     Bowers, L. (2005) Technical NNI 0001: A Subacute Dietary LC50 with

-------
               Mallards. Project Number: AS720801, 201263. Unpublished study
               prepared by Bayer Corp. 41 p.

46817006      Barfknecht, R. (2003) NNI-0001 Tech.: 5-Day-Dietary LC50 Bobwhite
               Quail (Colinus virginianus). Project Number: BAR/LC014,
               E/295/2268/4. Unpublished study prepared by Bayer Ag, Institute of
               Product Info. & Residue Anal. 33 p.
850.2300    Avian reproduction test
    MRID                           Citation Reference
46817008      Bowers, L. (2005) Effect of Technical NNI 0001 on Northern Bobwhite
               Reproduction. Project Number: AS741701, 201138. Unpublished study
               prepared by Bayer Corp. 143 p.
850.2500    Field testing for terrestrial wildlife
    MRID                            Citation Reference
46817012     Nguyen, D.; Gosch, H. (2005) Effect on Bombus terrestris of NNI 0001
              WG 24 and Decis Protech used at the Maximum Dose in Greenhouse
              Tomatoes. Project Number: 201492. Unpublished study prepared by
              Bayer Cropscience Gmbh. 36 p.

46817024     Wolf, C. (2006) Residues in Arthropod Prey of Birds and Mammals
              After the Application of NNI 0001 SC 480 (Active Substance NNI 0001)
              in a German Vineyard: Final Report. Project Number: WFC/FS/011,
              E/308/2687/4. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 89 p.

46817027     Frommholz, U. (2005) NNI-0001 SC 480: Influence on the Reproduction
              of the Collembola species Folsomia Candida Test in Artificial Soil.
              Project Number: E/314/2/870/5, LKC/COLL/40/05. Unpublished study
              prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 26 p.
850.3020    Honey bee acute contact toxicity
   MRID                            Citation Reference
46817009     Barth, M. (2002) Acute Toxicity of NNI-0001 a.i. to the Honeybee Apis
              Mellifera L. under Laboratory Conditions: Final Report. Project
              Number: 02/10/48/035. Unpublished study prepared by Biochem Agrar,
              Lab fuer Biologische und Chemische. 30 p.

46817010     Barth, M. (2002) Acute Toxicity of NNI-0001 SC 480 to the Honeybee
              Apis Mellifera L. under Laboratory Conditions: Final Report. Project
              Number: 01/10/48/034, 02/10/48/034. Unpublished study prepared by
              Biochem Agrar, Lab fuer Biologische und Chemische. 29 p.

-------
46817015      Waltersdorfer, A. (2004) Toxicity to the Ladybird Coccinella
               septempunctata L. (Coleoptera, Coccinellidae) using an Extended
               Laboratory Test Including Exposure to and Oral Uptake of NNI-0001 SC
               480. Project Number: CW03/029. Unpublished study prepared by Bayer
               Cropscience Gmbh. 27 p.
850.3040    Field testing for pollinators
    MRID                            Citation Reference
46817011      Schur, A. (2006) Assessment of Side Effects of NNI-0001 SC 480 on the
               Honey Bee (Apis mellifera L.) in the Semi-Field: Final Report. Project
               Number: 20051108/01/BZEU. Unpublished study prepared by GAB
               Biotechnologie Gmbh. 115 p.
850.4100    Terrestrial plant toxicity, Tier 1 (seeding emergence)
    MRID                            Citation Reference
46817034     Nguyen, D.; Gosch, H. (2005) Non-Target Terrestrial Plants: An
              Evaluation of the Effects of NNI-0001 WG 24 in the Seedling
              Emergence and Growth Test (Tier 1). Project Number: SE04/14,
              SE04/14/TIER/1. Unpublished study prepared by Bayer Cropscience
              Gmbh. 17 p.

46817035     Lechelt-Kunze, C. (2002) NNI-0001  SC 480: Pre - and Post - Emergence
              Screening for Herbicidal Activity. Project Number:
              LKC/NTPSCR/05/02. Unpublished study prepared by Bayer
              Cropscience Gmbh. 14 p.
850.4150    Terrestrial plant toxicity, Tier 1 (vegetative vigor)
   MRID                            Citation Reference
46817035     Lechelt-Kunze, C. (2002) NNI-0001 SC 480: Pre - and Post - Emergence
              Screening for Herbicidal Activity. Project Number:
              LKC/NTPSCR/05/02. Unpublished study prepared by Bayer
              Cropscience Gmbh. 14 p.

46817036     Christ, M.; Lam, C. (2005) Tier I Seedling Emergence and Vegetative
              Vigor: Nontarget Phytotoxicity Study Using NNI-0001 480SC. Project
              Number: 201376, EBAMX007, EBAM0367. Unpublished study
              prepared by Bayer Corp. 62 p.

46817037     Nguyen, D.;  Gosch, H. (2005) Non-Target Terrestrial Plants: An
              Evaluation of the Effects of NNI-0001 WG 24 in the Vegetative Vigor
              Test (Tier 1). Project Number: W04/14, W04/14/TIER/1. Unpublished
              study prepared by Bayer Cropscience Gmbh. 17 p.

-------
850.4400    Aquatic plant toxicity test using Lemna spp. Tiers I and II
    MRID                           Citation Reference
46817039     Kern, M.; Banman, C.; Lam, C. (2004) Toxicity of NNI 0001 Techncial
              to Duckweed (Lemna gibba G3) Under Static-Renewal Conditions.
              Project Number: EBAMX010, AS883701, 200604. Unpublished study
              prepared by Bayer Corp. 41 p.

46817040     Dorgerloh, M. (2005) Pseudokirchneriella subcapitata Growth Inhibition
              Test with NNI-0001 SC 480. Project Number: DOM/24031, 00789,
              MR/391/02. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 53 p.
850.5400    Algal toxicity, Tiers 1 and II
    MRID                            Citation Reference
46817041      Yamazaki, I. (2003) Algal Growth Inhibition Test of NNI-0001: Final
              Report. Project Number: GC/01, 02/0128, LSRCAT02/121A.
              Unpublished study prepared by Nihon Nohyaku Co., Ltd. 30 p.
860.1000    Background
    MRID                            Citation Reference
46817114     Muprhy, J. (2005) NNI-0001 480 SC - Magnitude of the Residue in/on
              Tobacco. Project Number: RAAMX048. Unpublished study prepared by
              Bayer Corp., Bayer CropScience Midwest Field Technology Station and
              Bayer Research Farm. 131 p.
860.1300    Nature of the residue - plants, livestock
   MRID                            Citation Reference
46817043      Baker, F.; Kimmel, E.; Estigoy, L. (2002) A Metabolism Study with
              [(Carbon 14)]-NNI-0001 on Apples. Project Number: 1027W/2, 1027W.
              Unpublished study prepared b: PTRL West, Inc. and Excel Research
              Services, Inc. 390 p.

46817044      Motoba, K. (2002) Metabolism Study of NNI-0001 in Cabbage: Final
              Report (Amended I). Project Number: GB/03, 01/0101,
              LSRC/M02/011 A. Unpublished study prepared by Nihon Nohyaku Co.,
              Ltd. 83 p.

46817045      Motoba, K. (2005) Metabolism Study of NNI-0001 in Cherry Tomato:
              Final Report (Amended II). Project Number: GB/03, 01/0069,
              LSRC/M01/122A. Unpublished study prepared by Nihon Nohyaku Co.,

-------
               Ltd. 97 p.

46817046      Krolski, M; Nguyen, T. (2005) The Metabolism of NNI-0001 in Corn.
               Project Number: AS041602/MEAMX009, AS041601/MEAMX010.
               Unpublished study prepared by Bayer Corp. 121 p.

46817047      Weber, H.; Koester, J.; Justus, K. (2005) [Aniline-UL-(Carbon 14)]NNI-
               0001: Absorption, Distribution, Excretion, and Metabolism in the
               Lactating Goat. Project Number: MEF/03/173, M51819123,
               M/l 81/9123/5. Unpublished study prepared by Bayer Ag, Institute of
               Product Info. & Residue Anal. 254 p.

46817048      Koester, J.; Justus, K.; Brueckner, H. (2005) [Phthalic-acid-UL-(Carbon
               14)]NNI-0001: Absorption, Distribution, Excretion, and Metabolism in
               the Lactating Goat. Project Number: Ml 1819129, MEF/04/173,
               M/181/9129/1. Unpublished study prepared by Bayer Ag, Institute of
               Product Info. & Residue Anal. 185 p.

46817049      Koester, J.; Justus, K. (2004) Metabolism of [Aniline-UL-(Carbon
               14)]NNI-0001 in the Laying Hen. Project Number: M81819126,
               MEF/04/055, M/181/9126/8. Unpublished study prepared by Bayer Ag,
               Institute of Product Info. & Residue Anal.  158 p.

46817050      Koester, J.; Justus, K.; Brueckner, H. (2005) Metabolism of [Phthalic-
               Acid-UL-(Carbon 14)]NNI-0001 in the Laying Hen. Project Number:
               M51819132, MEF/04/159, M/181/9132/5. Unpublished study prepared
               by Bayer Ag, Institute of Product Info. & Residue Anal. 151 p.
860.1340    Residue analytical method
    MRID                             Citation Reference
46816928     Netzband, D.; Yin, J. (2006) Independent Laboratory Validation of
              "Method 00838 (MR-134/03) for the Determination of NNI-0001 and
              NNI-0001-des-iodo in Drinking and Surface Water by HPLC-MS/MS".
              Project Number: RAAMX098, MR/134/03, 000838. Unpublished study
              prepared by Bayer Corp. 78 p.

46817101     Billian, P.; Wolters, A. (2006) Analytical Method 00816/M002 for the
              Determination of Residues of NNI-0001 and its Des-iodo Metabolite A-
              1 in/on Plant Material by HPLC-MS/MS Using Stable-Labelled Internal
              Standards. Project Number: P602030522, 00816/M002, MR/121/03.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 103 p.

46817102     Reiner, H. (2005) Extraction Efficiency Testing of the Residue Method
              for the Determination of NNI-0001 Residues in Corn Using Aged
              Radioactive Residues. Project Number: M9991366/3, MEF/04/0465.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &

-------
              Residue Anal. 41 p.

46817103      Class, T. (2005) Independent Laboratory Validation of Method
              00816/M001 for the Determination of Residues of NNI-0001 and Its
              Des-Iodo Metabolite A-l in/on Plant Material by HPLC-MS/MS:
              Demonstration of a LC/MS/MS Confirmatory Method. Project Number:
              P/866/G, P612050563, P/B/866/G. Unpublished study prepared by
              PTRL Europe Gmbh. 50 p.

46817104      Billian, P. (2005) Analytical Method 00912 for the Determination of
              Residues of NNI-0001 and its Metabolite A14  in/on Muscle, Liver and
              Kidney, Milk, Fat and Poultry Egg by HPLC-MS/MS. Project Number:
              MR/149/04, 00912, P603040541. Unpublished study prepared by Bayer
              Ag, Institute of Product Info. & Residue Anal.  177 p.

46817105      Justus, K.; Brueckner, H. (2005) [Phthalic acid-UL-(Carbon 14)] NNI-
              0001 : Extraction Efficiency of the Residue Analytical Method for the
              Determination of NNI-0001 and NNI-0001-lodophthalimide in Animal
              Tissues, Milk, and Eggs Using Aged Radioactive Residues. Project
              Number: M9991432/7, MEF/04/526. Unpublished study prepared by
              Bayer Ag, Institute of Product Info. & Residue Anal. 65 p.

46817106      Anspach, T. (2005) Independent Laboratory Validation of the Bayer
              CropScience Method No. 00912 for the Determination of Residues of
              NNI-001 and its Metabolite A-14 in/on Muscle, Fat and Poultry Egg by
              HPLC-MS/MS: Final Report. Project Number: BAY/0512V, G05/0019,
              P683050565. Unpublished study prepared by Dr. Specht and Partner.
              100 p.

47263101      Billian, P. (2007) Confirmation Method for Analytical Method
              00816/M002 for the Determination of Residues of NNI-001 and its des-
              iodo Metabolite A-l in/on Plant Material by HPLC-MS/MS Using
              Stable-Labelled Internal Standards. Project Number: P682070621,
              MR/07/300, M/290991/01/1. Unpublished study prepared by Bayer
              CropScience AG. 17 p.

47263102      Rotzoll, N. (2007) Independent Laboratory Validation of the Bayer
              CropScience Method 00816/M002 for the Determination of NNI-0001
              (Flubendiamide) and its Metabolite NNI-001-desiodo in Plant Matrices:
              Final Report. Project Number: BAY/0705V, G07/0117, P612070622.
              Unpublished study prepared by Eurofins Analytik GmbH. 72 p.
860.1360    Multiresidue method
   MRID                            Citation Reference
46817107     Wilson, T. (2006) Testing of NNI-0001 and Two Metabolites Through
              the FDA Multiresidue Methods as Described in the FDA Pesticide
              Analytical Manual (PAM) I, Appendix II, Updated 1/94. Project

-------
              Number: RAAMY017, 49859. Unpublished study prepared by
              Analytical Bio-Chemistry Labs., Inc. 95 p.
860.1380    Storage stability data
   MRID                            Citation Reference
46817108      Billian, P. (2005) Storage Stability of NNI-0001 in/on Tomato (Fruit),
              Cotton (Oil), Wheat (Grain), Head Cabbage (Head), Bean (Bean with
              Pod) and Citrus (Fruit) for 18 Months. Project Number: P642030518,
              MR/064/03, BCS/RD/D/ROCS. Unpublished study prepared by Bayer
              Ag, Institute of Product Info. & Residue Anal. 37 p.

46817109      Billian, P. (2005) Storage Stability of NNI-0001 -Des-Iodo in/on Tomato
              (Fruit), Plant Oil, Wheat (Grain), Head Cabbage (Head), Bean (Bean
              With Pod) and Citrus (Fruit) for 18 Months. Project Number:
              P642030520, BCS/RD/D/ROCS, MR/086/03. Unpublished study
              prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 37 p.

46817110      Murphy, I. (2006) Storage Stability of NNI-0001 and A-l (NNI-0001-
              Desiodo) in Various Crop Matrices. Project Number: RAAMY002,
              AM050804B/NNI/A1, AM060207A/34. Unpublished study prepared by
              Bayer Corp. 250 p.
860.1480    Meat/milk/poultry/eggs
   MRID                            Citation Reference
46817111      Billian, P.; Auer, S.; Eberhardt, R. (2005) NNI-0001: Dairy Cattle
              Feeding Study. Project Number: MR/030/05, P673050562,
              BCS/RD/D/ROCS. Unpublished study prepared by Bayer Ag, Institute
              of Product Info. & Residue Anal. 200 p.

46817112      Billian, P.; Eberhardt, R. (2005) NNI-0001: Feeding Study Laying Hens
              (Gallus gallus domesticus). Project Number: P673050566, BR/031/05,
              BCS/RD/D/ROCS. Unpublished study prepared by Bayer Ag, Institute
              of Product Info. & Residue Anal. 292 p.
860.1500    Crop field trials
   MRID                            Citation Reference
46817113      Krolski, M.; Harbin, A. (2006) NNI-0001 480 SC - Magnitude of the
              Residue in/on Field and Sweet Corn. Project Number: RCAMY004.
              Unpublished study prepared by Bayer Corp., Bayer CropScience
              Midwest Field Technology Station and Bayer Research Farm. 455 p.

46817114      Muprhy, J. (2005) NNI-0001 480 SC - Magnitude of the Residue in/on
              Tobacco. Project Number: RAAMX048. Unpublished study prepared by

-------
              Bayer Corp., Bayer CropScience Midwest Field Technology Station and
              Bayer Research Farm. 131 p.

46817115      Beedle, E. (2006) NNI-0001 480 SC - Magnitude of the Residue on
              Cotton. Project Number: RCAMY002. Unpublished study prepared by
              Bayer Corp., Texas A & M Food Protein Research & and GLP
              Technologies. 244 p.

46817116      Lenz, C. (2006) NNI-0001 480 SC - Magnitude of the Residue on Grape.
              Project Number: RCAMY016. Unpublished study prepared by Bayer
              Corp., Crop Management Strategies, Inc. and A.C.D.S. Research, Inc.
              152 p.

46817117      Xu, T.; Mackie, S. (2005) NNI-001 480 SC - Magnitude of the Residue
              on Pome Fruit (Apple and Pear). Project Number: RCAMY009.
              Unpublished study prepared by: Bayer Corp., A.C.D.S. Research, Inc.
              and Ag Research Associates. 354 p.

46817118      Helfrich, K.; Sandra, J.; Mackie, W. (2006) NNI-0001 480 SC -
              Magnitude of the Residue on Stone Fruit (Crop Group 12: Cherries,
              Plums, and Peaches). Project Number:  RCAMY011. Unpublished study
              prepared by Bayer Corp., Crop Management Strategies, Inc. and
              Agsearch.  357 p.

46817119      Pither,  K.; Mackie, S. (2006) NNI-0001 480 SC - Magnitude of the
              Residue on Tree Nuts (Almonds and Pecan). Project Number:
              RCAMY014. Unpublished study prepared by Bayer Corp., South Texas
              Ag Research, Inc. and Crop Guard Research, Inc. 245 p.

46817120      Fischer, D. (2005) NNI-0001 24 WG - Magnitude of the Residue in/on
              Fruiting Vegetables (Crop Group 8; Including Residue Reduction
            .  Information). Project Number: RCAMY006. Unpublished study
              prepared by Bayer Corp. 300 p.

46817121      Fischer, D. (2005) NNI-0001 24 WG - Magnitude of the Residue in/on
              Head and Stem Brassica (Crop Subgroup 5A; Including Residue
              Reduction Information). Project Number: RCAMY001. Unpublished
              study prepared by Bayer Corp., Bayer CropScience  and South Texas Ag
              Research, Inc. 301 p.

46817122      Fishcher, D. (2005) NNI-0001  24 WG  - Magnitude  of the Residue in/on
              Leafy Brassica Greens (Crop Subgroup 5B; Including Residue
              Reduction Information). Project Number: RCAMY001/1, 00816/M002.
              Unpublished study prepared by Bayer Corp., Bayer  CropScience and
              South Texas Agricultural Research. 274 p.

46817123      Dacus, S.;  Harbin, A. (2006) NNI-0001 24 WG - Magnitude of the
              Residue in/on Leafy Vegetables - (Crop Group 4; Including Residue
              Reduction Information). Project Number: RCAMY008, 00816/M002.
              Unpublished study prepared by Bayer Corp., Syntech Research and GLP

-------
              Research & Consulting. 449 p.

46817124     Zimmer, D.; Dacus, S. (2006) NNI-0001 24 WG - Magnitude of the
              Residue in/on Cucurbit Vegetables - Crop Group 9 (Including Reduction
              Information). Project Number: RCAMY015, 00816/M002. Unpublished
              study prepared by Bayer Corp., GLP Research & Consulting and South
              Texas Ag Research, Inc. 336 p.

46817125     Lenz, C. (2005) NNI-0001 480 SC - Magnitude of the Residue in/on
              Field Cora Grain, Com Aspirated Grain Fractions, and Com Processed
              Commodities. Project Number: RCAMY005, 00816/M002,
              AM050207B/NNI. Unpublished study prepared by Bayer Corp. and
              Texas A & M Research Center. 209 p.
860.1520    Processed food/feed
    MRID                           Citation Reference
46817125      Lenz, C. (2005) NNI-0001 480 SC - Magnitude of the Residue in/on
              Field Com Grain, Corn Aspirated Grain Fractions, and Corn Processed
              Commodities. Project Number: RCAMY005, 00816/M002,
              AM050207B/NNI. Unpublished study prepared by Bayer Corp. and
              Texas A & M Research Center. 209 p.

46817126      Murphy, J. (2006) NNI-0001 480 SC - Magnitude of the Residue on
              Cotton Processed Commodities. Project Number: RCAMY003,
              AM051128AD/NNI/A1, AM051128AD/NN1. Unpublished study
              prepared by Bayer Corp. and GLP Technologies. 137 p.

46817127      Lenz, C. (2005) NNI-0001 480 SC - Magnitude of the Residue on Grape
              Processed Commodities. Project Number: RCAMY017,
              AM050404ABC/NNI/A1, AM050404ABC/NNI. Unpublished study
              prepared by Bayer Corp., National Food Laboratory, Inc. and Excel
              Research Services, Inc. 150 p.

46817128      Lenz, C. (2006) NNI-0001 480 SC - Request for Waiver of the Study of
              the Magnitude of the Residue in/on Soybean Processed Commodities
              from a Rotational Crop of Soybeans. Project Number:  RAAMY014,
              00816/M002. Unpublished study prepared by Bayer Corp. and Texas A
              & M Food Protein Research &. 76 p.

46817129      Lenz, C. (2006) NNI-0001 480 SC - Request for Waiver of the Study of
              the Magnitude of the Residue in/on Wheat Processed Commodites from
              a Rotation Crop of Wheat. Project Number: RAAMY007, 00816/M002.
              Unpublished study prepared by Bayer Corp. 68 p.

46817130      Helfrich, K.; Mackie, S. (2005) NNI-0001 480 SC: Magnitude of the
              Residue on Apple Processed Commodities.  Project Number:
              RCAMY010, 00816/M002, AM041216C/NNI/A1. Unpublished study

-------
              prepared by Bayer Corp., National Food Laboratory, Inc. and Quails
              Agricultural Laboratories, I. 195 p.

46817131     Helfrich, K.; Mackie, S. (2006) NNI-0001 480 SC: Magnitude of the
              Residue on Plum Processed Commodities. Project Number:
              RCAMY012, AM050104A/NNI/A1, AM050104A/NNI. Unpublished
              study prepared by Bayer Corp. and National Food Laboratory, Inc. 126
              P-
46817132     Fischer, D. (2005) NNI-0001 24 WG - Magnitude of the Residue in/on
              Tomatoes and Tomato Processed Commodities. Project Number:
              RCAMY007, 00816/M002, MG6880. Unpublished study prepared by
              Bayer Corp. and National Food Laboratory, Inc. 233 p.
860.1850    Confined accumulation in rotational crops
    MRID                            Citation Reference
46817133      Reiner, H. (2004) Metabolism of [Aniline Ring-UL-(Carbon 14)] NNI-
              0001 in Confined Rotational Crops. Project Number: MEF/009/03,
              M/1031192/7. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 212 p.

46817134      Reiner, H. (2004) Metabolism of [Phthalic Acid Ring-UL-(Carbon 14)]
              NNI-0001 in Confined Rotational Crops. Project Number: MEF/008/03,
              M/1301191/6. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 214 p.
860.1900    Field accumulation in rotational crops
   MRID                            Citation Reference
46817135      Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in
              Barley (Rotational Crop Tolerance). Project Number: RAAMY009,
              AMOS 1115 A/NNI, AMOS 1115/NNI/A1. Unpublished study prepared by
              Bayer Corp. 192 p.

46817136      Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in
              Mustard Greens When Planted as a Roational Crop Following Treatment
              of Cotton, Squash, or Sweet Corn With NNI-0001 480 SC at the
              Maximum Proposed Label Specifications (Limited Rotational Crop).
              Project Number: AS19MG01, RCAM1000, AM/002/P05/01.
              Unpublished study prepared by Bayer Corp. 186 p.

46817137      Xu, T.; Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue
              in Sorghum (Rotational Crop Tolerance). Project Number: RAAMY012,
              00816/M002, AM050315BC/NNI. Unpublished study prepared by Bayer
              Corp., South Texas Ag. Research and Shoffner Farm Research. 194 p.

-------
 46817138      Duah, F.; Harbin, A. (2006) NNI-0001 480 SC - Magnitude of the
               Residue in Soybeans (Rotational Crop Tolerance). Project Number:
               RAAMY013, 00816/M002, AM050309AB/NNI. Unpublished study
               prepared by Bayer Corp., Agvise Inc. and Agresources, Inc. 275 p.

 46817139      Fischer, D. (2006) NNI-0001 280 SC - Magnitude of the Residue in
               Turnips When Planted as a Rotational Crop Following Treatment of
               Cotton, Squash, or Sweet Corn with NNI-0001 480 SC at the Maximum
               Proposed Label Specifications (Limited Rotational Crop). Project
               Number: AS19TU01, RCAM 1005, AM/002/P05/01. Unpublished study
               prepared by Bayer Corp. and South Texas Ag. Research. 211 p.

 46817140      Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in
               Wheat (Rotational Crop Tolerance). Project Number: RAAMY008,
               00816/M002, AM050412ABC/NNI/A1. Unpublished study prepared by
               Bayer Corp. and Quails Agricultural Laboratories, I. 251 p.

 46817141      Fischer, D. (2006) NNI-0001 480 SC - Magnitude of the Residue in
               Wheat When Planted as a Rotational Crop Following Treatment of
               Cotton, Squash, Mustard Greens, or Sweet Corn with NNI-0001 480 SC
               at the Maximum Proposed Label Specifications (Limited Rotational
               Crop). Project Number: RCAM1010, AS19WH01, AM/002/P05/01.
               Unpublished study prepared by Bayer Corp. 281 p.
 870.1000    Acute toxicity testing—background
    MRID                            Citation Reference
46817236     Langewische, F. (2006) Perinatal Ocular Toxicity Study in CD-1 Mice
              Following Exposure Via Diet: NNI-0001. Project Number: AT02781,
              TXAMX036, T2073354. Unpublished study prepared by Bayer Ag Inst.
              of Toxicology. 191 p.
870.1100    Acute oral toxicity
   MRID                            Citation Reference
46817142      Horiuchi, K. (2003) Acute Oral Toxicity Study of NNI-0001 in Rats:
              Final Report. Project Number: GA/01, 02/0004, LSRC/T02/026A.
              Unpublished study prepared by Nihon Nohyaku Co., Ltd., Agvise Inc.
              and Agro-Tech, Inc. 22 p.

46817143      Schungel, M. (2004) Acute Toxicity in the Rat After Oral
              Administration: NNI-0001 480 SC. Project Number: AT01182,
              TXAM0190, T/8074098. Unpublished study prepared by Bayer
              CropScience LP. 25 p.

46817144      Eiben, R. (2004) Acute Toxicity in the Rat After Oral Administration:
              NNI-0001 24 WG. Project Number: AT01622, T/3074651, ID64005/04.

-------
 870.1200
    MRID
   Unpublished study prepared by Bayer Ag Pflanzenschutz-Entwicklung.
   23 p.
Acute dermal toxicity
                         Citation Reference
 46817145
 46817146
46817147
870.1300
    MRID
   Horiuchi, K. (2003) Acute Dermal Toxicity Study of NNI-0001 in Rats:
   Final Report. Project Number: GA/01, 02/0005, LSRC/T02/027A.
   Unpublished study prepared by Nihon Nohyaku Co., Ltd. 22 p.

   Schungel, M. (2004) NNI-0001 480 SC: Acute Toxicity in the Rat After
   Dermal Application. Project Number: T/9074099, TXAM0195,
   AT01183. Unpublished study prepared by Bayer CropScience LP. 26 p.

   Eiben,  R. (2004) Acute Toxicity in the Rat After Dermal Application:
   NNI-0001 24 WG. Project Number: AT01623, T/4074652, TXAMX025.
   Unpublished study prepared by Bayer Ag Pflanzenschutz-Entwicklung.
   26 p.
Acute inhalation toxicity
                         Citation Reference
46817148     Wesson, C. (2004) NNI-0001: Acute Inhalation Toxicity (Nose Only)
              Study in the Rat. Project Number: 289/119. Unpublished study prepared
              by Safepharm Laboratories Ltd. 46 p.

46817149     Pauluhn, J. (2004) NNI-0001 480 SC: Acute Inhalation Toxicity in Rats.
              Project Number: TXAM0185, T5073302, AT01263. Unpublished study
              prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 67 p.

46817150     Christenson, W. (2006) Justification for Waiving an Acute Inhalation
              Toxicity Study With the 24WG Formulation of NNI-0001 Technical.
              Project Number: 201490. Unpublished study prepared by Bayer
              CropScience LP. 5 p.
870.2400    Acute eye irritation
    MRID                            Citation Reference
46817201      Horiuchi, K. (2004) Eye Irritation Study of NNI-0001 in Rabbits: Final
              Report. Project Number: GA/02, 02/0031, LSRC/T02/065A.
              Unpublished study prepared by Nihon Nohyaku Co., Ltd. 26 p.

46817202      Schungel, M. (2004) NNI-0001 480 SC: Acute Eye Irritation on Rabbits.
              Project Number: AT01509, T0074379, TXAM0175. Unpublished study
              prepared by Bayer Ag Inst. of Toxicology. 20 p.

46817203      Schungel, M. (2005) NNI-0001 24 WG: Acute Eye Irritation on Rabbits.

-------
               Project Number: AT01758, T/9074396, TXAMX028. Unpublished study
               prepared by Bayer Ag Inst. of Toxicology. 20 p.
 870.2500   Acute dermal irritation
    MRID                            Citation Reference
 46817204      Horiuchi, K. (2004) Skin Irritation Study of NNI-0001 in Rabbits: Final
               Report. Project Number: GA/02, 02/0030, LSRC/T02/064A.
               Unpublished study prepared by Nihon Nohyaku Co., Ltd. 21 p.
 46817205      Schungel, M. (2004) NNI-0001 480 SC: Acute Skin Irritation/Corrosion
               on Rabbits: Final Report. Project Number: T/9074378, AT01500.
               Unpublished study prepared by Bayer Ag Inst. of Toxicology. 19 p.
 46817206      Schungel, M. (2005) NNI-0001 24 WG: Acute Skin Irritation/Corrosion
               on Rabbits. Project Number: AT01752, TXAMX029, T/8074395.
               Unpublished study prepared by Bayer Ag Inst. of Toxicology. 20 p.
 870.2600    Skin sensitization
    MRID                           Citation Reference
46817207      Horiuchi, K. (2004) Skin Sensitization Study of NNI-0001 in Guinea
               Pigs (Maximization Test): Final Report. Project Number: GA/03,
               02/0003, LSRC/T03/077A. Unpublished study prepared by Nihon
               Nohyaku Co., Ltd. 47 p.

46817208      Vohr, H. (2004) NNI-0001 480 SC: Study for the Skin Sensitization
               Effect in Guinea Pigs (Buehler Patch Test). Project Number: AT01492,
               TXAM0202. Unpublished study prepared by Bayer Ag Inst. of
               Toxicology. 29 p.

46817209      Vohr, H. (2004) NNI-0001 24 WG: Study for the Skin Sensitization
               Effect in Guinea Pigs (Buehler Patch Test). Project Number: AT01645,
               TXAMX031, T/7074150. Unpublished study prepared by Bayer Ag Inst.
               of Toxicology. 26 p.
870.3100    90-Day oral toxicity in rodents
    MRID                            Citation Reference
46817210     Enomoto, A. (2003) NNI-0001: Repeated Dose 90-Day Oral Toxicity
              Study in Rats: Final Report. Project Number: IET/01/0013. Unpublished
              study prepared by Institute of Environmental Toxicology. 780 p.

46817211      Takeuchi, Y. (2002) NNI-0001: Repeated Dose 90-Day Oral Toxicity
              Study in Mice: Final Report. Project Number: IET/01/0049. Unpublished
              study prepared by Nihon Nohyaku Co., Ltd. 258 p.

-------
 870.3150    90-day oral toxicity in nonrodents
    MRID                            Citation Reference
 46817212      Kuwahara, M. (2003) NNI-0001: Repeated Dose 90-Day Oral Toxicity
               Study in Dogs: Final Report. Project Number: IET/01/0062.
               Unpublished study prepared by Institute of Environmental Toxicology.
               300 p.
 870.3200    21/28-day dermal toxicity
    MRID                            Citation Reference
 46817213      Krotlinger, F. (2004) 30-Day Toxicity Study in the Rat by Dermal
               Administration: NNI-0001. Project Number: AT01704, TXAM0026,
               T/6073709. Unpublished study prepared by Bayer Ag Inst. of
               Toxicology. 275 p.
 870.3700    Prenatal developmental toxicity study
    MRID                            Citation Reference
46817214      Takahashi, K. (2002) NNI-0001: Teratogenicity Study in Rabbits: Final
               Report. Project Number: IET/01/0128. Unpublished study prepared by
               Institute of Environmental Toxicology. 126 p.

46817215      Aoyama, H. (2003) NNI-0001: Teratogenicity Study in Rats: Final
               Report. Project Number: IET/02/0036. Unpublished study prepared by
               Institute of Environmental Toxicology. 117 p.

46817240      Takahashi, K. (2001) NNI-0001: Preliminary Teratogenicity Study in
               Rabbits: Final Report. Project Number: IET/01/0030. Unpublished study
               prepared by Institute of Environmental Toxicology. 96 p.

46817241      Aoyama, H. (2002) NNI-0001: Preliminary Teratogenicity Study in
               Rats: Final Report. Project Number: IET/01/0113. Unpublished study
               prepared by Institute of Environmental Toxicology. 93 p.
870.3800    Reproduction and fertility effects
   MRID                           Citation Reference
46817216     Hojo, H. (2004) NNI-0001: Reproductive Toxicity Study in Rats: Final
              Report. Project Number: IET/01/0127. Unpublished study prepared by
              Institute of Environmental Toxicology. 617 p.
870.4100    Chronic toxicity
   MRID                            Citation Reference

-------
 46817217      Enomoto, A. (2004) NNI-0001: Repeated Dose 1 -Year Oral Toxicity
               Study in Rats: Final Report. Project Number: T/8016, IET/01/0079.
               Unpublished study prepared by Institute of Environmental Toxicology.
               986 p.

 46817218      Kuwahara, M. (2004) NNI-0001: 52-Week Chronic Toxicity Study in
               Dogs: Final Report. Project Number: IET/02/0035. Unpublished study
               prepared by Institute of Environmental Toxicology. 415 p.
 870.4200    Carcinogenicity
    MRID                           Citation Reference
46817219      Enomoto, A. (2004) NNI-0001: Carcinogenicity Study in Rats: Final
               Report. Project Number: IET/02/0035, T/8059. Unpublished study
               prepared by Institute of Environmental Toxicology. 691 p.

46817220      Takeuchi, Y. (2004) NNI-0001: Carcinogenicity Study in Mice: Final
               Report. Project Number: IET/01/0126, T/8019. Unpublished study
               prepared by Institute of Environmental Toxicology. 648 p.
870.5100    Bacterial reverse mutation test
    MRID                           Citation Reference
46817221      Inagaki, K. (2003) Bacterial Reverse Mutation Test of NNI-0001: Final
              Report (Amendment 1). Project Number: GA/08, 02/0017,
              LSRC/T02/018A. Unpublished study prepared by Nihon Nohyaku Co.,
              Ltd. 39 p.

46817222      Herbold, B. (2004) NNI-0001 480 SC: Salmonella/Microsome Test Plate
              Incorporation and Preincubation Method. Project Number: AT01237,
              T/3073247, TXAMM004. Unpublished study prepared by Bayer Ag Inst.
              of Toxicology. 53 p.
870.5375    In vitro mammalian chromosome aberration test
    MRID                            Citation Reference
46817223      Miyahana, K. (2004) In Vitro Chromosome Aberration Test of NNI-
              0001 in Cultured Chinese Hamster Cells: Final Report. Project Number:
              GA/08, 02/0116. Unpublished study prepared by Nihon Nohyaku Co.,
              Ltd. 32 p.

46817224      Herbold, B. (2003) NNI-0001: V79/HPRT-Test In Vitro for the
              Detection of Induced Forward Mutations. Project Number: T/2071518,
              AT00460. Unpublished study prepared by Bayer Ag hist, of Toxicology.

-------
               36 p.
 870.5395   Mammalian erythrocyte micronucleus test
    MRID                            Citation Reference
 46817225      Miyahana, K. (2003) Micronucleus Test of NNI-0001 in Mice: Final
               Report. Project Number: GA/08, 02/0020, LSRC/T02/089A.
               Unpublished study prepared by Nihon Nohyaku Co., Ltd. 33 p.

 46817226      Herbold, B. (2005) NNI-001: Micronucleus-Test on the Male Mouse.
               Project Number: TXAMX034, AT01775, T/0073947. Unpublished study
               prepared by Bayer Ag Inst. of Toxicology. 49 p.
 870.6200    Neurotoxicity screening battery
    MRID                            Citation Reference
46817227      Gilmore, R.; Lake, S. (2003) An Acute Oral Neurotoxicity Screening
               Study with Technical Grade NNI-0001 in Fischer 344 Rats. Project
               Number: 02/N12/LC, 200489. Unpublished study prepared by Bayer
               Corp. 445 p.
870.6300    Developmental neurotoxicity study
    MRID                           Citation Reference
46817228      Sheets, L.; Gilmore, R.; Hoss, H. (2006) A Developmental Neurotoxicity
               Screening Study with Technical Grade NNI-0001 in Wistar Rats. Project
               Number: 04/D72/VK, 201448. Unpublished study prepared by Bayer
               Corp. 1136 p.
870.7485    Metabolism and pharmacokinetics
    MRID                            Citation Reference
46817229
46817230
46817231
Motoba, K. (2005) Absorption, Distribution, Metabolism and Excretion
of Radiolabeled NNI-0001 Following a Single Oral Administration to
Male and Female Rats: Final Report (Amended I). Project Number:
GB/01, 03/0022, LSRC/M04/115A. Unpublished study prepared by
Nihon Nohyaku Co., Ltd. 142 p.

Motoba, K. (2005) Absorption, Distribution, Metabolism and Excretion
of [phthalic ring (U)-(Carbon 14)] NNI-0001 Following 14 Repetitive
Oral Administration to Male and Female Rats: Final Report (Amended
I). Project Number: GB/01, 03/0222, LSRC/M04/114A. Unpublished
study prepared by Nihon Nohyaku Co., Ltd. 81 p.

Motoba, K. (2004) Biliary Excretion Study of [phthalic Ring-(U)-

-------
               (Carbon 14)] NNI-0001 Following a Single Oral Administration to Male
               and Female Rats: Final Report. Project Number: GB/01, 01/0151,
               LSRC/M04/107A. Unpublished study prepared by Nihon Nohyaku Co.,
               Ltd. 167 p.

46817232      Motoba, K. (2004) In Vitro Metabolism Study of NNI-0001: Final
               Report. Project Number: GB/05, 03/0181, LSRC/M04/184A.
               Unpublished study prepared by Nihon Nohyaku Co., Ltd. 57 p.

46817233      Motoba, K. (2005) Toxicokinetics of NNI-0001: Concentration in
               Selected Organs, Tissues and Plasma Following Repetitive Daily
               Administration to Rats and Mice: Final Report. Project Number: GA/25,
               05/0230, LSRC/M05/248A. Unpublished study prepared by Nihon
               Nohyaku Co., Ltd. 62 p.
870.7600    Dermal penetration
    MRID                            Citation Reference
46817234     Bomann, W. (2005) A Study to Determine the Dermal Absorption of
              NNI-0001 SC 480 when Administered Dermally to Male Rhesus
              Monkeys: Final Report. Project Number: VCBZ/0111/03/742, 201134,
              03C/B29/TL. Unpublished study prepared by Charles River
              Laboratories. 131 p.
870.7800    Immunotoxicity
   MRID                            Citation Reference
46817243      Krotlinger, F.; Vohr, H. (2005) Project: NNI-0001: Immunotoxicity
              Study in Rats - Plaque Assay (4-Weeks Administration by Diet). Project
              Number: AT02098, TXAMM002, T1073902. Unpublished study
              prepared by Bayer Ag Inst. of Toxicology. 149 p.
875.1300    Inhalation exposure—outdoor
   MRID                            Citation Reference
46817247      Standart, V. (2006) Occupational Exposure & Safety Assessment for
              Mixers/Loaders, Applicators and Reentry Workers During Use of.
              Project Number: 201475. Unpublished study prepared by Bayer
              CropScience LP. 27 p.
875.2100    Foliar dislodgeable residue dissipation
   MRID                            Citation Reference
46817246      Hoag, R.; Belcher, T. (2004) Renounce 20 WP - Dislodgeable Foliar

-------
875.2400
   MRID
  Residue and Worker Re-entry Following Application to Sweet Corn:
  Final Report. Project Number: CY251601, CY264601, RCBDY032.
  Unpublished study prepared by Bayer Corp. and Morse Laboratories,
  Inc. 667 p.
Dermal exposure
                         Citation Reference
46817246      Hoag, R.; Belcher, T. (2004) Renounce 20 WP - Dislodgeable Foliar
              Residue and Worker Re-entry Following Application to Sweet Corn:
              Final Report. Project Number: CY251601, CY264601, RCBDY032.
              Unpublished study prepared by Bayer Corp. and Morse Laboratories,
              Inc. 667 p.
875.2500    Inhalation exposure
   MRID                           Citation Reference
46817246      Hoag, R.; Belcher, T. (2004) Renounce 20 WP - Dislodgeable Foliar
              Residue and Worker Re-entry Following Application to Sweet Corn:
              Final Report. Project Number: CY251601, CY264601, RCBDY032.
              Unpublished study prepared by Bayer Corp. and Morse Laboratories,
              Inc. 667 p.
850.7100    Data reporting for environmental chemistry methods
   MRID                           Citation Reference
46816925      Seymour, R.; Beck, D. (2005) Independent Laboratory Validation of
              "Method 00849 for the Determination of Residues of NNI-0001, NNI-
              0001-des-iodo, NNI-0001-3-OH, NNI-0001-3-OH-
              hydroxyperfluoroalkyl and NNI-0001-Benzoic Acid in Soil and
              Sediment by HPLC-MS/MS". Project Number: RAAMX006, 00849.
              Unpublished study prepared by Bayer Corp. 76 p.

46816928      Netzband, D.; Yin, J. (2006) Independent Laboratory Validation of
              "Method 00838 (MR-134/03) for the Determination of NNI-0001 and
              NNI-0001-des-iodo in Drinking and Surface Water by HPLC-MS/MS".
              Project Number: RAAMX098, MR/134/03, 000838. Unpublished study
              prepared by Bayer Corp. 78 p.

46816929      Netzband, D.; Yin, J. (2006) Determination of NNI-0001 and NNI-0001-
              des-iodo in Drinking and Surface Water by LC/MS/MS. Project
              Number: AM/003/W06/01. Unpublished study prepared by Bayer Corp.
              27 p.

-------
850.1790    Chironomid Sediment Toxicity Test
   MRID                            Citation Reference
46817013      Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 SC 480 to Larvae of
              Chironomus riparius in a Static Laboratory Test System. Project
              Number: EBAMX024, E/322/2846/6. Unpublished study prepared by
              Bayer Ag, Institute of Product Info. & Residue Anal. 53 p.

46817014      Dorgerloh, M. (2005) Acute Toxicity of NNI-0001 WG 24 to Larvae of
              Chironomus riparius in a Static Laboratory Test System. Project
              Number: EBAMX023, E/322/2844/5. Unpublished study prepared by
              Bayer Ag, Institute of Product Info. & Residue Anal. 53 p.

46817022      Dorgerloh, M. (2003) Chironomus riparius 28-Day Chronic Toxicity
              Test with the NNI-0001 (Tech.) in a Water-Sediment System Using
              Spiked Water. Project Number: DOM/23005, E/416/2340/0, MR/188/02.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 102 p.

46817023      Dorgerloh, M. (2004) Chironomus riparius 28-Day Chronic Toxicity
              Test with NNI-0001-des-iodo in a Water-Sediment System Using Spiked
              Water. Project Number: DOM/23069, E/416/2518/7, 00838.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 130 p.
850.6200    Earthworm subchronic toxicity test
   MRID                            Citation Reference
46817028     Kunze, C. (2002) NNI-0001 (Tech.): Acute Toxicity to Earthworms
              (Eisenia fetida). Project Number: E/310/2293/0, LKC/RG/406/02,
              RG/11/02. Unpublished study prepared by Bayer Ag, Institute of Product
              Info. & Residue Anal. 14 p.

46817029     Lechelt-Kunze, C. (2004) NNI-0001 SC 480: Acute Toxicity to
              Earthworms (Eisenia fetida) Tested in Artificial Soil. Project Number:
              E/310/2772/2, RG/18/04, LKC/RG/A/35/04. Unpublished study
              prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 22 p.

46817030     Lechelt-Kunze, C. (2004) NNI-0001 -des-iodo: Acute Toxicity to
              Earthworms (Eisenia fetida) Tested in Artificial Soil with 5% Peat:
              Amended Report. Project Number: E/310/2564/1, LKC/RG/A/21/04.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 23 p.

46817031     Luhrs, U. (2002) NNI-0001 SC480: Effects on Reproduction and Growth
              of Earthworms Eisenia fetida in Artificial Soil:  Final Report. Project
              Number: 14421022. Unpublished study prepared by Institut fuer

-------
              Biologische Analytik und Consulting IBACON. 33 p.

46817032     Lechelt-Kunze, C. (2005) NNI-0001 WG 24: Effects on Survival,
              Growth and Reproduction on the Earthworm Eisenia fetida Tested in
              Artificial Soil. Project Number: E/312/2847/7, LKC/RG/R/11/05,
              RG/19/05. Unpublished study prepared by Bayer Ag, Institute of Product
              Info. & Residue Anal. 39 p.
850.7100    Data reporting for environmental chemistry methods
    MRID                            Citation Reference
46817042     Barfknecht, R. (2006) Dissipation of the Active Substance NNI-0001
              from Exposed Grass After a Spray Application with NNI-0001 SC 480.
              Project Number: E/308/2949/5, BAR/FS/027. Unpublished study
              prepared by Bayer Ag, Institute of Product Info. & Residue Anal. 37 p.
 Non-Guideline Study
   MRID                             Citation Reference
46816900     Bayer CropScience LP and Nichino America, Inc. (2006) Submission of
              Product Chemistry, Residue, Fate, Environmental Fate and Toxicity Data
              in Support of the Application for Registrations of NNI-0001 Techncial,
              NNI-0001 480 SC and NNI-0001 24 WG, and the Petition for Tolerance
              of Flubendiamide on Corn (Field Corn, Pop Corn, Sweet Corn, and Corn
              Grown for Seed), Cotton, Tobacco, Tree Fruit, Nut, and Vine Crops and
              Vegetable Crops. Transmittal of 49 of 201 Studies.

46816918     Hellpointner, E. (2003) Calculation of the Chemical Lifetime of NNI-
              0001  in the Troposphere. Project Number: M1451332/9, MEF/362/03.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal.  13 p.

46816919     Hellpointner, E. (2004) Determination of the Quantum Yield and
              Assessment of the Environmental Half-life of the Direct
              Photodegradation in Water: NNI-0001. Project Number: M1431261/8,
              MEF/099/03, M/143/1261/8. Unpublished study prepared by Bayer Ag,
              Institute of Product Info. & Residue Anal. 35 p.

46816920     Hellpointner, E. (2003) Determination of the Quantum Yield and
              Assessment of the Environmental Half-life of the Direct
              Photodegradation in Water: NNI-0001-Des-Iodo. Project Number:
              M1431300/2, MEF/214/03, M/143/1300/2. Unpublished study prepared
              by Bayer Ag, Institute of Product Info. & Residue Anal. 32 p.

46816921     Hellpointner, E. (2004) Determination of the Quantum Yield and
              Assessment of the Environmental Half-Life of the Direct Photo-
              degradation in  Water: NNI-0001-3-OH-hydroxyperfluoroalkyl (A 10).

-------
              Project Number: M1431306/8, MEF/275/03, M/143/1306/8.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 43 p.

46816922      Babczinski, P. (2004) Outdoor Soil Degradation of [(Carbon 14)]NNI-
              001. Project Number: MEF/04/418, M1251280/9, M/125/1280/9.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 126 p.

46816923      Brumhard, B. (2006) Determination of the Storage Stability of NNI-
              0001, NNI-OOOl-des-iodo, NNI-0001-3-OH, NNI-0001-3-OH-
              Hydrxyperfluoroalkyl and NNI-OOOl-Benzoic Acid in Soil. Project
              Number: P641030027, MR/06/014. Unpublished study prepared by
              Bayer Ag, Institute of Product Info. & Residue Anal. 80 p.

46816924      Brumhard, B. (2004) Analytical Method 00849 for the Determination of
              Residues of NNI-0001, and its Metabolites NNI-OOOl-des-iodo, NNI-
              0001-3-OH, NNI-OOOl-3-OH-Hydroxyperfluroalkyl and NNI-OOOl-
              Benzoic Acid in Soil and Sediment by HPLC-MS/MS. Project Number:
              P601030020, MR/202/03, 00849. Unpublished study prepared by Bayer
              Ag, Institute of Product Info. & Residue Anal. 94 p.

46816926      Seymour, R.; Beck, D. (2004) NNI-0001: Analytical Method AM-001-
              S04-01 for Determination of Residues of NNI-0001, NNI-OOOl-des-iodo,
              NNI-0001-3-OH, NNI-0001 -3-OH-Hydroxyperfluoroalkyl and NNI-
              OOOl-Benzoic Acid in Soil and Sediment by HPLC-MS/MS. Project
              Number: AM/001/S04/01. Unpublished study prepared by Bayer Corp.
              38 p.

46816927      Brumhard, B. (2004) Analytical Method 00838 (MR-134/03) for the
              Determination of NNI-OOOl-des-iodo in Drinking and Surface Water by
              HPLC-MS/MS. Project Number: P684/037058, MR/134/03, 00838.
              Unpublished study prepared by Bayer Ag, Institute of Product Info. &
              Residue Anal. 28 p.

46817000      Bayer Cropscience LP and Nichino America, Inc. (2006) Submission of
              Fate, Environmental Fate and Toxicity Data in Support of the
              Application for Registration of NNI-0001 Technical, NNI-0001 480 SC,
              NNI-0001 24 WG and the Petition for Tolerance of Flubendiamide for
              Use in/on Corn, Cotton, Tobacco, Tree Fruit, Vegetable Crops, Nut and
              Vine Crops. Transmittal of 50 Studies.

46817016      Moll, M. (2005) Effects of NNI-0001 SC 480 on the Ladybird Beetle
              Coccinella septempunctata, Extended Laboratory Study -Aged Residue
              Test-  :Final Report. Project Number: 24321013. Unpublished study
              prepared by Institut fuer Biologische Analytik und Consulting IBACON.
              46 p.

46817017      Maus, C. (2002) Evaluation of the Effects of NNI-0001  SC 480 on the
              Life Cycle of Ladybird Beetles (Coccinella septempunctata) under

-------
              Extended Laboratory Conditions. Project Number: E/398/2289/1,
              MAUS/CS004. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 38 p.

46817018     Waltersdorfer, A. (2004) Toxicity to the Green Lacewing Chrysoperla
              camea Steph. (Neuroptera, Chrysopidae) Using an Extended Laboratory
              Test: NNI-0001 SC 480 Water Miscible Suspension Concentrate. Project
              Number: CW03/030. Unpublished study prepared by Bayer Cropscience
              Gmbh. 26 p.

46817019     Waltersdorfer, A. (2005) Toxicity to the Predatory Mite Typhlodromus
              pyri Scheuten (Acari, Phytoseiidae) in the Laboratory: NNI-0001 24 WG
              Water Dispersible Granules. Project Number: CW05/025. Unpublished
              study prepared by Bayer Cropscience Gmbh. 34 p.

46817020     Waltersdorfer, A. (2005) Toxicity to the Parasitoid Wasp Aphidius
              rhopalosiphi (DeStephani-Perez) (Hymenoptera: Braconidae) in the
              Laboratory: NNI-0001 24 WG Water Dispersible Granules. Project
              Number: CW05/021. Unpublished study prepared by Bayer Cropscience
              Gmbh. 25 p.

46817021     Fussell, S. (2002) A Rate-Response Laboratory Test to Determine the
              Effects of NNI-0001 SC 480 on the Parasitic Wasp, Aphidius
              rhopalosiphi. Project Number: BAY/02/5. Unpublished study prepared
              by Mambo-Tox Ltd. 26 p.

46817025     Anderson, J. (2002) Influence of NNI-0001 SC 480 on Glucose
              Stimulated Respiration in  Soils. Project Number: AJO/233002, 2749,
              E/3 3 0/2277/4. Unpublished study prepared by Bayer Ag, Institute of
              Product Info. & Residue Anal. 21 p.

46817026     Anderson, J. (2002) Influence of NNI-0001 SC 480 on the Microbial
              Mineralization of Nitrogen in Soils. Project Number: E/337/2278/2,
              AJO/233102, 2750. Unpublished study prepared by Bayer Ag, Institute
              of Product Info. & Residue Anal. 17 p.

46817100     Bayer CropScience LP and Nichino America (2006) Submission of
              Residue and Toxicity Data in Support of the Application for
              Registrations of Flubendiamide, NNI-0001 480 SC and NNI-0001 24
              WG and the Petition for Tolerance of Flubendiamide on Corn (Field
              Corn, Pop Corn, Sweet Corn, and Corn Grown for Seed), Cotton,
              Tobacco, Tree Fruit, Nut and Vine Crops and Vegetable Crops.
              Transmittal of 50 of 200 Studies.

46817200     Bayer CropScience LP and Nichino America, Inc. (2006) Submission of
              Toxicity, Fate, Environmental Fate, Residue, Exposure and RiskData in
              Support of the Application for Registration of NNI-0001 Technical,
              NNI-0001 480 SC, NNI-0001 24 WG and the Petition for Tolerance of
              Flubendiamide for Use on Com, Cotton, Tobacco, Tree Fruit, Nut and
              Vine Crops and Vegetable Crops. Transmittal of 52 of 202 Studies.

-------
4681723 5      Amanuma, T. (2005) Effect of NNI-0001 Administration on the
              Thyroid-Related Hormones and Liver Drug-Metabolizing Enzymes in
              Female F-344 Rats. Project Number: GA/11, 02/0162, LSRC/T05/041 A.
              Unpublished study prepared by Nihon Nohyaku Co., Ltd. 118 p.

46817237      Freyberger, A. (2003) NNI-0001: Studies on Interactions with
              lodothyronine Deidinase Type I in Vitro. Project Number: AT00471,
              T2071996. Unpublished study prepared by Bayer Ag Inst. of
              Toxicology. 20 p.

4681723 8      Takeuchi, Y. (2005) NNI-0001: One-Generation Reproductive Toxicity
              Study in Rats Histopathological Examination of the Eyes of Weanlings:
              Final Report. Project Number: IET/04/0075. Unpublished study prepared
              by Institute of Environmental Toxicology. 50 p.

46817239      Hojo, H. (2004) NNI-0001: One-Generation Reproductive Toxicity
              Study in Rats: Final Report. Project Number: IET/03/0013. Unpublished
              study prepared by Institute of Environmental Toxicology. 354 p.

46817242      Kuwahara, M. (2001) NNI-0001:  Repeated Dose 28-Day Oral Toxicity
              Study in Dogs: Final Report. Project Number: IET/01/0019.
              Unpublished study prepared by Institute of Environmental Toxicology.
              115 p.

46817248      Sabbagh, G. (2006) Aquatic Exposure Assessment for NNI-0001. Proj ect
              Number: MEAMY002. Unpublished study prepared by Bayer Corp. 67
              P-
46817249      Sabbagh, G. (2006) Screening Level Drinking Water Exposure
              Assessment for the Use . Project Number: MEAMY001. Unpublished
              study prepared by Bayer CropScience LP. 52 p.

46817250      Lenz, C. (2006) Aggregate Dietary Exposure to NNI-0001 and
              Assessment of Potential Risk. Project Number: RGAMY004.
              Unpublished study prepared by Bayer CropScience LP. 71 p.

46817251      Hall, T.; Sabbagh, G.; Kelly, I. (2005) Environmental Fate and
              Ecological Risk Assessment for NNI-0001. Project Number:
              EBAMP027. Unpublished study prepared by Bayer CropScience LP. 94
              P-
46817252      Buckelew, L.; Larochelle, D.; Christenson, R.; et al. (2006) NNI-0001
              (Flubendamide): Human Health Risk Assessment for Use on Corn,
              Cotton, Tobacco, Tree Nut, Vine  Crops and Vegetable Crops. Project
              Number: G201491, M/268723/01/1. Unpublished study prepared by
              Bayer CropScience LP. 117 p.

47263100      Nichino America, Inc. (2007) Submission of Residue Data in  Support of
              the Application for Registration of NNI-0001 Technical. Transmittal of 2
              Studies.

-------
47325300     Bayer CropScience (2008) Submission of Public Interest Data in Support
              of the Application for Registration of NNI-0001 Technical. Transmittal
              of 1 Study.

47325301     Nelson, J.; Speas, J.; Kelly, I.; et al. (2008) Public Interest Document
              Supporting the Registration of Flubendiamide (NNI-0001) to Control
              Commercially Important Lepidoptera Pests in Corn, Cotton, Tobacco,
              Leafy Vegetables and Vegetable, Tree Fruit, Nut and Vine Crops.
              Project Number: PID/BAY06JN23. Unpublished study prepared by
              ABG, Inc. 135 p.

-------