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
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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
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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
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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;
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(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
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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
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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
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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
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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
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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
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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
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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.
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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
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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).
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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
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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.
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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.
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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.
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