### 2 

# REGISTRATION REVIEW

PROBLEM FORMULATION

Indoxacarb

CAS Number 173584-44-6

US EPA PC CODE 067710

Prepared by: Robin Sternberg, Ph.D., Wildlife Biologist Christopher M. Koper, M.S., Chemist

Environmental Risk Branch 1

Reviewed by: Michael Lowit, Ph.D., Ecologist Meghan Radtke, Ph.D., Biologist

Environmental Risk Branch 1 U.S. Environmental Protection Agency Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch I 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460 N N O Cl

O N

O

CH 3 O O F

F F O

O C H 3

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## Contents

1 Introduction ......................................

................................................... .................................... 5

2 Previous Assessments ..............................

................................................... ............................ 5

2.1 Ecological Risk Assessments .......................

................................................... ................. 5

2.2 Drinking Water Assessments ........................

................................................... ................ 6

3 Overview of Indoxacarb Use ........................

................................................... ....................... 6

4 Environmental Fate Summary ........................

................................................... ..................... 9

4.1 Clean Water Act ...................................

................................................... ....................... 10

5 Ecological Effects Summary.........................

................................................... ..................... 11

5.1 Parent: Indoxacarb.................................

................................................... ...................... 11

5.2 Indoxacarb Degradates .............................

................................................... ................... 15

5.2.1 Terrestrial Effects................................

................................................... ................. 15

5.2.2 Aquatic Effects....................................

................................................... ................. 15

5.3 Review of Incident Databases ......................

................................................... ............... 17

6 Risk Hypothesis ...................................

................................................... .............................. 18

7 Exposure Pathways of Concern ......................

................................................... ................... 19

8 Analysis Plan .....................................

................................................... ................................ 19

8.1 Stressors of Concern...............................

................................................... ..................... 20

8.1.1 Terrestrial Assessment ............................

................................................... ............. 20

8.1.2 Aquatic Assessment ................................

................................................... ............. 20

8.2 Measures of Exposure ..............................

................................................... ................... 21

8.3 Measures of Effect ................................

................................................... ...................... 21

8.4 Integration of Exposure and Effects ...............

................................................... ............. 21

8.5 Drinking Water Assessment .........................

................................................... ............... 22

8.6 Endangered Species Assessments ....................

................................................... ........... 22

8.7 Endocrine Disruptor Screening Program .............

................................................... ....... 23

9 Data Gaps .........................................

................................................... .................................. 23

9.1 Environmental Fate Data ...........................

................................................... .................. 23

9.2 Ecological Effects Data ...........................

................................................... .................... 25

10 References ........................................

................................................... .................................. 32

11 Bibliography of Cited MRIDs .......................

................................................... .................... 33

Appendix A: Indoxacarb’s Degradation Profile .....

................................................... .................. 40

Appendix B: SIP (v 1.0) Inputs and Results ........

................................................... ...................... 45

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Appendix C: STIR (v 1.0) Inputs and Results .......

................................................... .................... 47

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## 1 Introduction

The purpose of this problem formulation is to provi de an understanding of the environmental fate and ecological effects of the registered uses of indoxacarb in support of Registration Review. Indoxacarb is a non-systemic oxadiazine in secticide registered for agricultural and non-agricultural use. Indoxacarb exists as an iso mer pair taking form as the active (S) isomer KN128 and inactive (R) isomer KN127. The me chanism of action of indoxacarb involves blockage of the neuronal sodium channel. The insecticidal activity of indoxacarb is thought to be attributed to the rapid and extensive conversion of (S) isomer KN128 to the

more active metabolite IN-JT333 in insects. IN-JT3 33 has greater affinity for the sodium channel complex of insects than the parent compound

.



## 2 Previous Assessments

Indoxacarb was first registered as a pesticide unde r the Federal Insecticide, Fungicide and Rodenticide Act in 2000 to control various lepidopt eran pests on apples, pears, broccoli, cabbage, cauliflower, sweet corn, head and leaf let tuce, tomatoes, bell and non-bell peppers,

and cotton.

2.1 Ecological Risk Assessments

EFED has conducted multiple ecological risk assessm ents for new uses of indoxacarb. The most recent assessment was in support of IR-4 propo sed new uses on dry and snap beans, small fruit vine climbing subgroup 13-07F, and low- growing berry subgroup 13-07H (2013; DP 4042424 and 4042425). The 2013 ecological risk assessment indicated that the proposed uses of indoxacarb may cause direct effects to:

• listed and non-listed birds from acute exposure for all proposed uses;

• listed and non-listed mammals from acute and chroni c exposure for all proposed uses;

• listed freshwater fish from acute exposure for use on dry and snap beans and listed and non-listed freshwater fish from acute exposure for use on cranberry;

• listed and non-listed freshwater fish from chronic exposure for use on cranberry;

• listed estuarine/marine fish from acute exposure an d listed and non-listed estuarine/marine fish from chronic exposure for all proposed uses;

• listed freshwater invertebrates from acute exposure and listed and non-listed freshwater invertebrates from chronic exposure for use on cranberry; and

• listed and non-listed estuarine/marine invertebrate s from acute and chronic exposure for all proposed uses (listed vs. non-listed depend s of use). 1


### Risk to terrestrial plants from all proposed uses w as presumed due to the lack of toxicity data and the documented ‘probable’ plant incident involv ing indoxacarb. In addition, given that indoxacarb is highly toxic to honey bees and target s insects, the assessment concluded that the potential for risk to terrestrial invertebrates exists.

1 Agency LOCs were exceeded for the bulleted taxa an d exposure durations. For listed species, direct o r indirect effects for particular species were not definitivel y determined; further investigation into temporal, geographical, and biological associations between the proposed uses a nd affected taxa would be needed before definitive effects

determinations could be made.

### 6

2.2 Drinking Water Assessments

The most recent drinking water assessment was condu cted to support the IR-4 proposed new uses on dry beans, snap beans, small fruit vine cli mbing subgroup 13-07F, and low-growing berry subgroup 13-07H (2013; DP 402100). The recom mended estimated drinking water concentrations (EDWCs) for the human health risk-as sessment were based on the highest predicted value for surface water – two application s of 0.1125 lb a.i./A/season on cranberry.



## 3 Overview of Indoxacarb Use

Registered uses of indoxacarb are provided in Table 3-1 . Indoxacarb is formulated as a suspension concentrate and water-dispersible granul e as well as multiple types of bait for nonagricultural use. There are two formulations of in doxacarb registered for agricultural use on crops and several types of formulations for use in bait stations or gels. Indoxacarb may be applied by ground or aerial equipment, depending on the use. Application methods include broadcast, chemigation, and foliar spray for agricu ltural uses and mound treatment, perimeter treatment, bait application, spot treatment, crack and crevice treatment, bait application, outdoor general surface spray, high volume spray, and spot- on treatment (for dogs and cats) for nonagricultural uses.

Table 3-1. Registered Uses of Indoxacarb
Agricultural, Food Uses Alfalfa Beets (unspecified) Brassica (head and stem ) vegetables Bushberries Corn, sweet Cotton (unspecified) Cranberry Fruiting vegetables Cucurbit vegetables Leafy greens Leafy vegetables Mint/peppermint/spear mint Grapes Okra Peanuts (unspecified) Peanuts (unspecified) Pear Peas, southern Pome fruits Potato, white/Irish Root and tuber vege tables Soybeans (unspecified) Spinach Stone fruits Non-Agricultural, Food Uses Commercial storages/warehouses

premises Eating establishments Food processing plant premises (nonfood contact) Food stores/markets/supermarkets

premises Household/domestic dwellings indoor food handling areas Agricultural, Non-Food Uses Alfalfa Fruits (unspecified) Tree nuts Non-Agricultural, Non-Food Uses Airports/landing field Cats (adults/kittens) Commer cial/industrial lawns

Commercial/institutional/ industrial premises/equipment (indoor/outdoor) Commercial storages/ warehouses premises Commercial transportation facilitiesnon-feed/non-food Conifers (plantations/nurseries) Dogs/canines (adul ts/puppies) Eating establishments Eating establishments food handling areas (non-food contact) Eating establishments non-food areas (non-food contact) Food processing plant non-food handling areas Food processing plant premises (non-food contact) Food stores/markets/supermarkets premises Golf course turf

Hospitals/medical institutions premises (human/veterinary) Household/domestic dwellings indoor/outdoor premises Industrial/construction areas (outdoor) Nonagricultural rights-of-way/ fencerows/hedgerows Nonagricultural uncultivated

areas/soils Ornamental and/or shade trees

### 7

Ornamental herbaceous plants Ornamental lawns and t urf Ornamental non-flowering plants Ornamental woody shrubs and vines Paths/patios Pave d areas (private roads/sidewalks) Public buildings/structures (vert. pest control) Recreational areas Recreation area lawns

Refuse/solid waste containers (garbage cans) Refuse/solid waste sites (outdoor) Residential lawn s

Ships and boats Utility poles/rights-of-way Wood pr otection treatment to buildings/products indoor/outdoor Wood protection treatment to forest products (seaso ned) Zoos



### A Label Data Report 2 

### by the Biological and Economic Analysis Division ( BEAD) provides application rates for all registered uses of indoxa carb. For agricultural uses, maximum single application rates range from 0.0656 lb a.i./A to 0. 1125 lb a.i./A, with two to four applications allowed per crop cycle for a maximum application ra te of 0.22 to 0.45 lb a.i./A/crop cycle. Application intervals range from 3 to 21 days for a gricultural crops. The Registration Review ecological risk assessment will be based on label i nformation that is current at the time of the assessment. To reduce uncertainty in the risk asse ssment, the Agency requests that the registrant provide additional label information where necessar y on the number of applications per year, the total amount applied per year (rather than on a per season basis), and the application interval.

The results of a Screening Level Usage Analysis (SL UA) for indoxacarb 2 

### by BEAD are provided

in Table 3

- 2 . This analysis lists agricultural uses of indoxac arb in terms of estimated total pounds of active ingredient. SLUA data sources inc lude:

• USDA-NASS (United States Department of Agriculture' s National Agricultural Statistics Service)

• Private Pesticide Market Research

• California DPR (Department of Pesticide Regulation) The top 3 agricultural uses of indoxacarb from 2004 to 2011 in terms of pounds of a.i. applied were alfalfa, cotton, and tomatoes.

Table 3-2. Screening Level Estimates of Agricultura l Uses of Indoxacarb, Sorted Alphabetically (Reporting Timeframe: 2004-2011)

Crop Average Annual

lb a.i. Annual Percent Crop Treated

Average Maximum

Alfalfa 10,000 <1 <2.5 Apples 2,000 5 10

Broccoli 5,000 50 70 Brussels Sprout* <500 NC NC Cabbage 2,000 25 35 Cantaloupes <500 5 10

Cauliflower 1,000 40 60 Celery <500 5 5

Cherries <500 <1 <2.5

Cotton 10,000 <1 <2.5

Cucumbers <500 <1 <2.5 Grapes <500 <1 <2.5

Lettuce 4,000 10 40

2 Date: December 10, 2012

### 8

Crop Average Annual

lb a.i. Annual Percent Crop Treated

Average Maximum

Nectarines 1,000 15 15

Peaches <500 <2.5 <2.5

Peanuts 3,000 <2.5 10

Pears <500 <1 <2.5 Peppers 1,000 15 30

Plums/Prunes <500 <2.5 5

Potatoes 1,000 <1 <2.5 Pumpkins <500 <2.5 <2.5 Soybeans 4,000 <1 <2.5 Spinach <500 <2.5 5 Squash <500 <2.5 5

Sweet Corn 1,000 <2.5 10

Tomatoes 9,000 20 40

Watermelons <500 5 10

All numbers are rounded. <500: indicates less than 500 pounds of active ingr edient. <2.5: indicates less than 2.5 percent of crop is tr eated. <1: indicates less than 1 percent of crop is treate d. * California data only. NC: not calculated, only pounds a.i. available. SLUA data sources include: USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service); Private Pesticide Market Research; California DPR ( Department of Pesticide Regulation) These results reflect amalgamated data developed by the Agency and are releasable to the public.



### Figure 3-1 depicts spatial use intensity of indoxacarb in the United States, which is mainly in

southern Florida and southern California.

Figure 3-1. Indoxacarb Usage by Crop Reporting Dist rict (2007-2011)
This is a map of agricultural pesticide usage at th e Crop Reporting District (CRD) level prepared by B EAD for use

in the Environmental Fate and Effects Division docu ments. These maps are used to help visualize where the pesticide being considered is most likely to be use d and can be helpful in scenario selection and plac ing the exposure

assessment in context. CRDs are boundaries created by USDA NASS which are aggregates of counties. Pest icide usage is displayed as average pounds (for the years 2007-2011) per 1,000 acres of farmland in a CRD to normalize

for the variation in farmland between CRDs. Farmlan d acreage was obtained from USDA (2007). Usage is b ased on private market surveys of pesticide use in agricult ure (Proprietary Data, 2007-2011).

### 9



## 4 Environmental Fate Summary

The major routes of degradation for indoxacarb incl ude alkaline-catalyzed hydrolysis (pH 9 t 1/2 

### ~ 1 day) and photodegradation in water (t 1/2 

### ~ 3 to 5 days). Indoxacarb’s low water solubility, high log Kow value, and relatively high Kd values sugges t the tendency to partition to soil; therefore, a low potential for soil leaching is expected. In addition, batch equilibrium and soil column leaching studies suggest low mobility of indoxacarb and IN-JT333 in terrestrial and aquatic environments. Terrestrial Field Dissipation (TFD) studies showed movement of parent and residues but none were detected below 45 cm (18 inc hes). Plant and soil volatility studies indicate that indoxacarb has low volatility from pl ant and soil surfaces with less than 3% of applied radioactivity volatilizing from lettuce pla nts and soil surface. Microbial mediated degradation varied, with aerobic degradation occurr ing at a faster rate then anaerobic degradation. Calculated fish bioconcentration fact ors (BCF) were 1044-1351X for whole fish tissues with the depuration half-life occurring as less than 10 days.

The physical, chemical, and environmental fate prop erties of indoxacarb are summarized in

Table 4-1 . In addition, since EFED is following the Toxic E quivalency (TEQ) approach (see

Section 8.1.2 for details) for its ecological risk assessment, i nput parameter data for the INJT333 and IN-MP819 degradates will be needed. In t he absence of data, EFED will assume these degradates are stable and utilize QSAR (EPISu ite ver. 4.0) modeling to estimate the physical and chemical properties needed for modelin g inputs. Appendix A summarizes the maximum formation of indoxacarb degradation product s.

Table 4-1. Nature of the Chemical Stressor

Parameter Value Source/MRID #

Common name Indoxacarb (active S-isomer)

Product Chemistry CAS number 173584-44-6 Chemical name Methyl 7-chloro-2,5-dihydro-2 [[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine4a(3H)-carboxylate Chemical Class/Category Oxadiazine insecticide Empirical formula C 22 H 17 ClF 3 N 3 O 7

Structure

(active S isomer)

Molecular Mass 527.8 g/mole Water Solubility 0.8 mg/L at 20 ° C
Vapor pressure (25 ° C) 1.9 x 10 - 10 mm Hg
Henry’s Law Constant 1.6 x 10 - 10 atm m 3 /mol Calculated 1

Octanol/water partition 44,668 (log Kow = 4.65) Pro duct Chemistry N N O Cl

O N

O

CH 3 O O F

F F O

O C H 3

### 10

Parameter Value Source/MRID #
coefficient (K

ow ) Dissociation Constant (pKa) No ionization at any en vironmentally-relevant pH Product Chemistry

Hydrolysis (t 1/2 ) pH 5 = 519, 578 days pH 7 = 38, 21.8 days pH 9 = 1, 1.11days 44477301

45795801

Aqueous Photolysis (t 1/2 ) (pH 5) 3.16 days 5.0 days 44477302

45795802 Soil Photolysis stable 44477303

Aerobic Soil Metabolism (t 1/2 ) 3 days 3 days 6 days 27 days 10 days 30 days 693 days 44477304

44477307

45850001

45166303

45166303

45166303

45166303

Aerobic Aquatic Metabolism (t 1/2 ) 30.7 days 39.8 days 38.1 days 21.3 days 52.0 days 58.0 days 36.0 days 42.0 days 45793301

45793301

45793301

45793301

44477306

44477306

44477306

44477306

Anaerobic Aquatic Metabolism (t 1/2 ) 192.5 days 315.1 days 147.0 days 231.0 days 45795804

45795804

44477305

44477305

Soil Partition Coefficient (K d ) (mL/g) 29.1

29.3

25.3

34.5

110.9

86.1

47.5

32.0 45795809

Terrestrial Field Dissipation (t 1/2 ) 72 - 79 days (FL, CA bare sand) 44477312, 44477315,

44477316

29-113 days (DE, TX bare ground) 44477311

73-119 days (CA, FL bare ground) 45850002

Bioaccumulation in Fish (BCF) 395 to 504X in edible tissues

1568 to 2081X for non-edible tissues

1044 to 1351X for whole fish 44477319

45805301

1 = Henry’s Law (atm-m 3 /mole) = (VAPR/760)/(SOL/MWT), where VAPR is vapor pressure in torr, MWT is molecular weight in g/mol, and SOL is the solubilit y in water in mg/L.



### 4.1 Clean Water Act

Indoxacarb is not identified as a cause of impairme nt for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 3 

### In addition, no Total Maximum Daily Loads

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation_ cy.cause_detail_303d?p_cause_group_id=885

### 11

(TMDL) have been developed. 4 

### The Agency invites submission of water quality dat a for this pesticide. To the extent possible, data should con form to the quality standards in Appendix A of

the OPP Standard Operating Procedure: Inclusion of Impa ired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Asse ssment and Management Process 5 

### , in order to ensure they can be used quantitatively or qualit atively in pesticide risk assessments.



## 5 Ecological Effects Summary

5.1 Parent: Indoxacarb

A summary of the available aquatic and terrestrial toxicity data for the two isomers of indoxacarb from registrant-submitted studies is pro vided in Table 5-1 . Endpoints for the mammalian hemolytic effect of indoxacarb are also i ncluded in this table.

Toxicity data for parent indoxacarb are not availab le for the following:

• acute toxicity to a passerine species,

• acute oral toxicity to larval honey bees, and

• toxicity to terrestrial plants (seedling emergence and vegetative vigor).

It should be noted that the predominant toxic isome r for acute effects in mammals is likely to be the (S) isomer KN128 ( i.e. , A mixture of 79% (S) isomer KN128 and 21% (R) iso mer KN127 yielded an LD 50 

### of 268 mg/kg-bw in female rats. Converting this e ndpoint to (S) isomer KN128 yields an LD 50 

### of 212 mg/kg-bw which is comparable to the LD 50 

### of 179 mg/kg-bw for the (S) isomer KN128 alone).

The estuarine/marine fish acute study with parent i ndoxacarb as 79% (S) isomer KN128: 21% (R) isomer KN127, i.e. , DPX-MP062, yielded a non-definitive endpoint ( i.e. , LC 50 

### > 0.37 mg a.i./L; MRID 44477222). The study was deemed scien tifically sound but classified as Supplemental because the test material was not test ed to the maximum solubility obtainable under brackish water conditions. Forty percent mor tality and sublethal effects including erratic swimming and partial loss of equilibrium were obser ved at the highest treatment concentration. In the absence of additional data, the conservative assumption of an LC 50 

### of 0.37 mg a.i./L will be used for characterizing risk to estuarine/marine fish from acute exposure to parent indoxacarb.

4 http://iaspub.epa.gov/tmdl_waters10/attains_nation. tmdl_pollutant_detail?p_pollutant_group_id=885&p_po llutant_ group_name=PESTICIDES

5 http://www.epa.gov/oppfead1/cb/ppdc/2006/november06 /session1-sop.pdf12Table 5-1. Endpoints Used to Characterize the Effects of Parent Indoxacarb as 79% (S) isomer KN128: 21% (R) isomerKN127,i.e.,DPX-MP062, and its Isomers[(S) isomer KN128 and (R) isomer KN127] to Aquatic and Terrestrial OrganismsStudy TypeChemical (%)SpeciesToxicity Endpoints1, Effects & Acute ToxicityClassification (If Applicable)MRID &ClassificationAvian acute oralDPW-MP062 (94.5)Bobwhite quail(Colinus virginianus)LD50= 98 mg a.i./kg-bwModerately toxic44477201AcceptableIndoxacarb Passerine speciesNo dataAvian sub-acute dietaryDPW-MP062 (94.5)Bobwhite quail(Colinus virginianus)LC50= 808 mg a.i./kg-dietModerately toxic44491701AcceptableDPW-MP062 (94.5)Mallard duck(Anas platyrhynchos)LC50> 5620 mg a.i./kg-dietPractically non-toxic44477204AcceptableAvian reproductionDPW-MP062 (94.5)Bobwhite quail(Colinus virginianus)NOEC = 144 mg a.i./kg-diet44477205AcceptableDPW-MP062 (94.5)Mallard duck(Anas platyrhynchos)NOEC = 720 mg a.i./kg-diet44477206AcceptableMammalian acute oralDPW-MP062 RatFemale LD50= 268 mg a.i./kg-bwMale LD50>1000 mg a.i./kg-bwModerately toxic44477113(S) isomer KN128 (99.7) RatFemale LD50= 179 mg a.i./kg-bwMale LD50= 843 mg a.i./kg-bwModerately toxic44477115Mammalian chronic(15-day developmental,dietary)50% (S) isomer KN128:50% (R) isomer KN127aRatMaternal NOEC = 20 mg a.i./kg-diet(based on reduced weight)Developmental NOEC = 40 mg a.i./kg diet(based on reduced fetal weight)44477139Mammalian chronic(90-day dietary)(S) isomer KN128 (99.7) RatMale NOEC = 10 mg a.i./kg-dietFemale NOEC < 10 mg a.i./kg-diet(based on hemolytic effects)44477129DPW-MP062 RatMale NOEC = 20 mg a.i./kg-dietFemale NOEC = 8 mg a.i./kg-diet(based on hemolytic effects)44477132Terrestrial invertebrateacute contact50% (S) isomer KN128:50% (R) isomer KN127aHoney bee(Apis mellifera)LD50= 0.18 μg a.i./beeHighly toxic44477234AcceptableTerrestrial invertebrateacute oral50% (S) isomer KN128:50% (R) isomer KN127aHoney bee(Apis mellifera)LC50> 1000 mg a.i./kg-diet44477235AcceptableIndoxacarbLarval honey bee(Apis mellifera)No data13Study TypeChemical (%)SpeciesToxicity Endpoints1, Effects & Acute ToxicityClassification (If Applicable)MRID &ClassificationTerrestrial invertebrateresidue on foliage30% (S) isomer KN128:10% (R) isomer KN127Honey bee(Apis mellifera)@ 0.12 lb/A, significant mortality after 24-hr exposure to3-hr aged alfalfa foliage@ 0.15 lb/A, significant mortality after 24-hr exposure to3-, 8-, and 24-hr aged alfalfa foliage44477236AcceptableTerrestrial plantseedling emergenceIndoxacarbNo dataTerrestrial plantvegetative vigorIndoxacarbNo dataFreshwater fish acuteDPX-MP062 (94.5)Channel catfish(Ictalurus punctatus)96-hr LC50(95% C.I.) = 0.29 (0.25-0.39) mg a.i./LHighly toxic44477211AcceptableRainbow trout(Oncorhynchus mykiss)96-hr LC50= 0.65 mg a.i./LHighly toxic44477209Acceptable75% (S) isomer KN128:25% (R) isomer KN127(94.5)Rainbow trout(Oncorhynchus mykiss)96-hr LC50(95% C.I.) = 0.90 (0.71-1.46) mg a.i./LHighly toxic44477210Acceptable29.3% (S) isomer KN128:10.3% (R) isomer KN127(39.6)Rainbow trout(Oncorhynchus mykiss)96-hr LC50(95% C.I.) = 0.71 (0.55-0.95) mg a.i./LHighly toxic44477215Acceptable(TEP)14.7% (S) isomer KN128:4.3% (R) isomer KN127(19)Rainbow trout(Oncorhynchus mykiss)96-hr LC50> 1.3 mg a.i./LAt most moderately toxic44477213Supplemental29.3% (S) isomer KN128:10.3% (R) isomer KN127(39.6)Bluegill sunfish(Lepomis macrochirus)96-hr LC50(95% C.I.) = 1.2 (0.9-1.6) mg a.i./LHighly toxic44477214Acceptable(TEP)50% (S) isomer KN128:50% (R) isomer KN127a(94.7)Carp(Cyprinus carpio)96-hr LC50(95% C.I.) = 1.02 (0.88-1.16) mg a.i./LModerately toxic44487901Supplemental50% (S) isomer KN128:50% (R) isomer KN127a(95)Carp(Cyprinus carpio)96-hr LC50> 0.32 mg a.i./LAt most highly toxic44477212SupplementalKN127 (99.8)Rainbow trout(Oncorhynchus mykiss)96-hr LC50(95% C.I.) = 0.394 (0.29-0.64) mg a.i./LHighly toxic44477218AcceptableFreshwater fish chronicDPX-MP062 (94.5)Rainbow trout(Oncorhynchus mykiss)NOEC = 0.15 mg a.i./LLOEC = 0.25 mg a.i./L(based on survival and growth)44477228SupplementalEstuarine/marine fishacuteDPX-MP062 (94.5)Sheepshead minnow(Pimephales promelas)96-hr LC50> 0.37 mg a.i./LAt most highly toxic44477222Supplemental14Study TypeChemical (%)SpeciesToxicity Endpoints1, Effects & Acute ToxicityClassification (If Applicable)MRID &ClassificationEstuarine/marine fishchronicDPX-MP062 (94.5)Sheepshead minnow(Pimephales promelas)NOEC = 0.017 mg a.i./LLOEC = 0.042 mg a.i./L(based on survival)44477226AcceptableFreshwater invertebrateacuteDPX-MP062 (94.5)Water flea(Daphnia magna)48-hr EC50(95% C.I.) = 0.6 (0.57-0.66) mg a.i./LHighly toxic44477219Acceptable50% (S) isomer KN128:50% (R) isomer KN127a(94.7)Water flea(Daphnia carinata)48-hr EC50(95% C.I.) = 2.94 (2.48-3.34) mg a.i./LModerately toxic44487902SupplementalFreshwater invertebratechronicDPX-MP062 (95)Water flea(Daphnia magna)NOEC = 0.075 mg a.i./LLOEC = 0.19 mg a.i./L(based on survival)44477225AcceptableEstuarine/marineinvertebrate acuteDPX-MP062 (94.5)Mysid shrimp(Mysidopsis bahia)96-hr LC50(95% C.I.) = 0.0542 (0.0443-0.0657) mg a.i./L44477223AcceptableEastern oyster(Crassostrea virginica)EC50(95% C.I.) = 0.203 (0.165-0.250) mg a.i./LHighly toxic44477224AcceptableEstuarine/marineinvertebrate chronicDPX-MP062 (94.5)Mysid shrimp(Mysidopsis bahia)NOEC = 0.0184 mg a.i./LLOEC = 0.0407 mg a.i./L(based on survival of F1 generation; # young/female;growth)44477227AcceptableAquatic non-vascularplantDPX-MP062 (94.5)Marine diatom(Skeletonema costatum)EC50(95% C.I.) = 1.22 (1.12-1.32) mg a.i./LEC05= 0.76 mg a.i./LNOEC < 1.07 mg a.i./L44477231AcceptableGreen alga(Pseudokirchneriellasubcapitata)EC50> 0.110 mg a.i./LNOEC = 0.110 mg a.i./L44491702AcceptableFreshwater diatom(Navicula pelliculosa)EC50> 1.68 mg a.i./LNOEC = 1.68 mg a.i./L44477232AcceptableCyanobacterium(Anabaena flos-aquae)EC50> 1.93 mg a.i./LNOEC = 1.93 mg a.i./L44477233AcceptableAquatic vascular plantDPX-MP062 (94.5)Duckweed(Lemna gibba)EC50> 0.084 mg a.i./LNOEC = 0.084 mg a.i./L44477230Supplementalaalso known as DPX-JW062

### 15

5.2 Indoxacarb Degradates

A summary of the available aquatic and terrestrial toxicity data for degradates of indoxacarb from registrant-submitted studies is provided in Table 5-2

.

5.2.1 Terrestrial Effects

Data for terrestrial organisms indicate that:

• degradate IN-JT333 is of limited acute toxicity to birds when compared to parent indoxacarb ( i.e. , LD 50 

### = 1618 mg/kg-bw for IN-JT333 vs. LD 50 

### = 98 mg/kg-bw for parent indoxacarb);

• degradate IN-KG433 is of comparable toxicity to mam mals when compared to parent indoxacarb ( i.e. , LD 50 

### = 174 mg/kg-bw for KG433 vs. LD 50 

### = 268 mg/kg-bw for parent indoxacarb); and

• IN-JT333 is more acutely toxic to mammals than pare nt indoxacarb ( i.e. , LD 50 

### = 39 mg/kg-bw for IN-JT333 vs. LD 50 

### = 268 mg/kg-bw for parent indoxacarb).

Since degradates IN-KG433 and IN-JT333 were not ide ntified as major degradates during fate studies of the hydrolysis or photolysis of parent i ndoxacarb, fate processes that EFED considers important to dissipation of non-volatile pesticides from vegetation, neither will be considered

stressors of concern in the terrestrial assessment.

5.2.2 Aquatic Effects

The data indicate that degradate IN-JT333 is more a cutely toxic to freshwater fish than parent indoxacarb ( i.e. , for rainbow trout, LC 50 

### = 0.024 mg/L for IN-JT333 vs. LC 50 

### = 0.65 mg/L for parent indoxacarb), and degradate IN-MP819 is more acutely toxic to freshwater invertebrates than parent indoxacarb ( i.e. , for Daphnia , LC 50 

### = 0.064 mg/L for IN-MP819 vs. LC 50 

### = 0.6 mg/L for parent indoxacarb). As a result, both IN-JT333 and IN-MP819 will be considered stressors of concern in the aquatic assessment ( Section 8.1.2 ). However, there are no data to assess chronic toxicity of these degradates to freshwater fish and invertebrates or acute and chronic toxicity to estuarine/marine fish and invertebrates . In the absence of these data, these toxicity endpoints will be estimated using available toxicit y data for parent indoxacarb and acute toxicity relationships between the degradates and parent (es timates are bolded in Table 5-2 ).

The freshwater fish acute study with degradate IN-M P819 yielded a non-definitive endpoint ( i.e.

, LC 50 

### > 0.368 mg a.i./L; MRID 46022501). The study was deemed scientifically sound but classified as Supplemental because fish wet weight at test termination (range of 20 fish from negative and solvent control groups = 0.35-0.72 g) ranged lower than the minimum of the required initial weight range (0.5 to 5 g). Forty percent mortality and sublethal effects including partial loss of equilibrium, labored or rapid respi ration, fish lying on bottom, and lethargy were observed at the highest treatment concentration. T herefore, in the absence of additional data, the conservative assumption of an LC 50 

### of 0.368 mg a.i./L will be used for characterizing risk to freshwater fish from acute exposure to IN-MP819.

### 16

The freshwater invertebrate acute study with degrad ate IN-JT333 yielded a non-definitive endpoint ( i.e. , EC 50 

### > 0.029 mg a.i./L; MRID 44477221). The study was deemed scientifically sound but classified as Supplemental because a defi nitive EC 50 

### was not obtained. Five percent mortality was observed at the highest treatment con centration. For the purpose of characterizing risk to freshwater invertebrates from acute exposur e to IN-JT333, the conservative assumption that IN-JT333 and parent indoxacarb as DPX-MP062 (7 9% (S) isomer KN128: 21% (R) isomer KN127) are equally toxic to freshwater invertebrate s will be made ( i.e. , LC/EC 50 

### = 0.6 mg a.i./L)

in the absence of additional data.

Table 5-2. Endpoints Used to Characterize the Effec ts of Indoxacarb Degradates IN-JT333, IN-KG433, and IN-MP819 to Aquatic and/or Terrestria l Organisms

Study Type Degradate

(%) Species Toxicity Endpoints 1 , Effects and Acute Toxicity Classification (If Applicable) MRID &

Classification

Avian acute oral IN-JT333

(98.7) Bobwhite quail

( Colinus virginianus ) LD 50 = 1618 mg a.i./kg-bw

Slightly toxic 44477203 Acceptable

Mammal acute

oral IN-JT333

(98.7) Rat Female LD 50 = 39 mg a.i./kg-bw

Male LD 50 = 52 mg a.i./kg-bw Highly toxic 44477117

IN-KG433 (98) Rat Female LD 50 = 174 mg a.i./kg-bw

Male LD 50 > 2000 mg a.i./kg-bw Moderately toxic 44477116

Freshwater fish

acute IN-MP819 Rainbow trout ( Oncorhynchus mykiss ) 96-hr LC 50 > 0.368 mg a.i./L

At most highly toxic 46022501 Supplemental

IN-JT333 (98.7) Rainbow trout

( Oncorhynchus mykiss ) 96-hr LC 50 (95% C.I.) = 0.024 (0.012-0.22)

mg a.i./L Very highly toxic 44477216 Acceptable

Freshwater fish

chronic IN-MP819 NA Estimated NOEC = 0.0849 mg a.i./L = (DPX-MP062 Rainbow Trout NOEC *

absolute IN-MP819 Rainbow trout LC 50 ) /

DPX-MP062 Rainbow trout LC 50 ) NA

IN-JT333 NA Estimated NOEC = 0.0055 mg a.i./L = (DPX-MP062 Rainbow Trout NOEC *

IN-JT333 Rainbow trout LC 50 ) / DPXMP062 Rainbow trout LC 50 NA

Estuarine/marine

fish acute IN-MP819 NA Estimated LC 50 = 0.2095 mg a.i./L = (absolute DPX-MP062 Sheepshead

minnow LC 50 * absolute MP819 Rainbow

trout LC 50 ) / DPX-MP062 Rainbow trout

LC 50 NA

IN-JT333 NA Estimated LC 50 = 0.0137 mg a.i./L = (absolute DPX-MP062 Sheepshead

minnow LC 50 * JT333 Rainbow trout LC 50 )

/ DPX-MP062 Rainbow trout LC 50 NA

Estuarine/marine

fish chronic IN-MP819 NA Estimated NOEC = 0.0096 mg a.i./L = (DPX-MP062 Sheepshead minnow NOEC * (absolute IN-MP819 Rainbow

trout LC 50 / DPX-MP062 Rainbow trout

LC 50 ) NA

### 17

Study Type Degradate

(%) Species Toxicity Endpoints 1 , Effects and Acute Toxicity Classification (If Applicable) MRID &

Classification

IN-JT333 NA Estimated NOEC = 0.0006 mg a.i./L = DPX-MP062 Sheepshead minnow NOEC * (IN-JT333 Rainbow trout LC 50 / DPXMP062 Rainbow trout LC 50 ) NA

Freshwater

invertebrate

acute IN-MP819 Water flea ( Daphnia

magna ) 48-hr EC 50 = 0.064 mg a.i./L

Very highly toxic 46005801 Acceptable

IN-JT333 (98.7) Water flea

( Daphnia

magna ) 48-hr EC 50 > 0.029 mg a.i./L

At most very highly toxic 44477221 Supplemental

Freshwater

invertebrate

chronic IN-MP819 NA Estimated NOEC = 0.008 mg a.i./L= (DPX-MP062 Daphnia NOEC * INMP819 Daphnia EC 50 ) / DPX-MP062 Daphnia EC50 NA

IN-JT333 NA Estimated NOEC = 0.0036 mg a.i./L = (DPX-MP062 Daphnia NOEC * absolute IN-JT333 Daphnia EC 50 ) / DPX-MP062 Daphnia EC 50 NA

Estuarine/marine

invertebrate

acute IN-MP819 NA Estimated LC 50 = 0.0058 mg a.i./L = (DPX-MP062 Mysid LC 50 * IN-MP819 Daphnia EC 50 ) / DPX-MP062 Daphnia

EC50 NA

IN-JT333 NA Estimated LC 50 = 0.0026 mg a.i./L = (DPX-MP062 Mysid LC 50 * absolute INJT333 Daphnia EC 50 ) / DPX-MP062 Daphnia EC50 NA

Estuarine/marine

invertebrate

chronic IN-MP819 NA Estimated NOEC = 0.002 mg a.i./L = (DPX-MP062 Mysid NOEC * IN-MP819 Daphnia EC 50 ) / DPX-MP062 Daphnia

EC 50 NA

IN-JT333 NA Estimated NOEC = 0.0001 mg a.i./L = (DPX-MP062 Mysid NOEC * absolute JT333 Daphnia EC 50 ) / DPX-MP062 Daphnia EC 50 NA

N/A = not applicable

1 BOLD values are estimated toxicity endpoints.



### 5.3 Review of Incident Databases

Three databases, the Ecological Incident Informatio n System (EIIS) maintained by the Environmental Fate and Effects Division, the Aggreg ate Summary Module (ASM) of Office of Pesticide Program’s Incident database maintained by the Information Technology and Resource Management Division, and the Avian Incident Monitor ing System (AIMS) maintained by the American Bird Conservancy, were searched on Februar y 6, 2013 to locate incidents resulting from the use of indoxacarb. No incidents were repo rted in AIMS. There were three incidents reported in EIIS, all of which were the result of r egistered uses (see Table 5-3 ).

Table 5-3. Details of Incidents Associated with th e Use of Indoxacarb

Incident #

Date Species Use Site State Magnitude Response Route of Exposure Certainty Legality

I014139-007 Apricot Tomato CA $250,000 Plant Drift, Probable Re gistered

### 18

Incident #

Date Species Use Site State Magnitude Response Route of Exposure Certainty Legality

5/24/2003 damage spray use

I016479-001

8/14/1999 Bee Cotton CA 164 bee

hives Mortality Treated directly Possible Registered

use
I016138-001

10/11/2004 Cauliflower Cauliflower CA 70 acres Plant damage Treated

directly Unlikely Registered

use



### Incident I014139-007, which has a certainty factor of ‘probable’, occurred in Fresno, California, on May 24, 2003 and involved aerial application of Avaunt insecticide to a tomato field resulting in spray drift onto an adjacent apricot orchard. A vaunt was approved for tomatoes but not for apricots at the time of the incident. Analysis of r esidues from the orchard showed two samples were positive for indoxacarb.

Incident I016479-001, which has a certainty factor of ‘possible’, occurred in the California counties of Kern and Tulare on August 14, 1999 and involved application to cotton resulting in a bee kill. The pesticide applicator failed to notify the County prior to spraying a pesticide that is potentially harmful to bees. Analysis of the bees s howed the presence of chlorpyrifos (0.11 ppm) and indoxacarb (0.04 ppm) residues.

Incident I016138-001, which has a certainty factor of ‘unlikely’, occurred in Brawley, California and involved application of Avaunt insecticide, Per methrin 3.2 EC, and SI 200 Organo Silicone RNA to a 70-acre crop of cauliflower. In a lawsuit regarding the plant damage, the plaintiff alleged that the insecticide mixture was “contamina ted and adulterated with herbicides, including without limitation, the herbicide Pursuit.” Pursuit contains the active ingredient imazethapyr and is not registered for cauliflower. Damage was so se vere that the crop was unfit for human consumption and unmarketable. There was no evidence that the pesticide mixture contained

Pursuit.

Two incidents were reported in the Aggregate Incide nt Data System. One involved minor plant damage and took place in 2003 (Package and Seq. # 0 14811-00017), and the other involved a non-target organism and took place in 2012 (Package and Seq. # 024727-00017).

It should be noted that a lack of reported incident s should not be taken as an indicator of little or no ecological risk.



## 6 Risk Hypothesis

A risk hypothesis describes the predicted relations hip among the stressor, exposure, and assessment endpoint response along with the rationa le for their selection. For indoxacarb, the following ecological risk hypothesis will be tested in the Registration Review ecological risk

assessment:

Based on the application methods, mode of action, f ate and transport, and the sensitivity of non-target aquatic and terrestrial species, indo xacarb has the potential to reduce survival, reproduction, and/or growth in non-target terrestrial and aquatic plants, aquatic fish and invertebrates, terrestrial inverte brates, as well as birds and mammals

### 19

when used in accordance with the current labels. Th ese non-target organisms include Federally-listed threatened and endangered species as well as non-listed species.



## 7 Exposure Pathways of Concern

For terrestrial vertebrates, the major route of exp osure to indoxacarb is considered to be via dietary ingestion of food items such as seeds, plan ts, and/or animals that have indoxacarb residues as a result of direct application, spray d rift, and runoff. Exposure to indoxacarb through the consumption of drinking water alone is not cons idered a potential concern for birds and mammals based on the results of EFED’s Screening Im bibition Program (SIP v. 1.0) ( Appendix

B ). Exposure to terrestrial vertebrates through inh alation is considered not likely significant given indoxacarb’s low vapor pressure and the resul ts of EFED’s Screening Tool for Inhalation Risk using a conservative non-definitive endpoint f or rat inhalation toxicity (STIR v. 1.0) ( Appendix C ).

For terrestrial invertebrates, the major routes of exposure to indoxacarb are considered to be direct contact as a result of direct application an d spray drift and dietary ingestion of plants/pollen/nectar, animals, and/or soil that hav e indoxacarb residues as a result of direct application, spray drift, and runoff.

For aquatic animal species, the major route of expo sure to indoxacarb is considered to be uptake via the respiratory surface (gills) or the integume nt from surface water/sediment that has indoxacarb residues as a result of spray drift, run off, and leaching to groundwater from soil.

For terrestrial (upland and semi-aquatic) non-targe t plants, the major routes of exposure to

indoxacarb are considered to be direct contact as a result of direct application and spray drift and root uptake via soil contaminated via spray drift a nd runoff.

For aquatic plants, the major routes of exposure to indoxacarb are considered to be uptake from surface water/sediment containing indoxacarb residu es as a result of spray drift, runoff, and leaching to groundwater from soil.



## 8 Analysis Plan

To address the risk hypothesis, the potential for a dverse effects on the environment will be estimated. Usage, environmental fate, and ecologic al effects of indoxacarb will be characterized and integrated to assess the risks. As outlined in the Overview Document (USEPA, 2004), the likelihood of effects to individual organisms from particular uses of a chemical is estimated using the probit dose-response slope and either the level of concern (LOC) or the actual calculated risk quotient (RQ) value.

This analysis plan will be revisited and may be rev ised depending upon a full review of the data available in the open literature and the informatio n submitted by the public in response to the opening of the Registration Review docket.

### 20

8.1 Stressors of Concern

8.1.1 Terrestrial Assessment

Since degradates IN-KG433 and IN-JT333 were not ide ntified as major degradates during fate studies of the hydrolysis or photolysis of parent i ndoxacarb, fate processes that EFED considers important to dissipation of non-volatile pesticides from vegetation, neither will be considered

stressors of concern in the assessment for terrestr ial vertebrates ( i.e. , birds and mammals). Therefore, only parent indoxacarb will be considere d a stressor of concern in the assessment for terrestrial vertebrates for the Registration Review ecological risk assessment.

Given that acute effects in mammals can be attribut ed mostly to (S) isomer KN128 of parent indoxacarb, mammalian acute estimated environmental concentrations (EECs) in the Registration Review ecological risk assessment will be based on the application rate in terms of the (S) isomer KN128 alone, and the toxicity endpoi nt used for calculating mammalian acute RQs will be that for the (S) isomer alone ( i.e. , LD 50 

### of 179 mg/kg-bw).

8.1.2 Aquatic Assessment

Results of registrant-submitted studies indicate th at degradate IN-JT333 is more acutely toxic to freshwater fish than parent indoxacarb and that deg radate IN-MP819 is more acutely toxic to freshwater invertebrates than parent indoxacarb. T herefore, indoxacarb and degradates INJT333 and IN-MP819 will be considered stressors of concern in the assessment for aquatic animals ( i.e. , fish and aquatic invertebrates) of the Registrati on Review ecological risk assessment. Specifically, the toxic equivalency (T EQ) approach will be used to assess both parent indoxacarb and degradates IN-JT333 and IN-MP 819. The following steps will be taken to implement this approach and calculate acute and chr onic RQs for each aquatic animal taxa: a) Aquatic animal acute and chronic toxicity endpoints (mg/L) for parent indoxacarb and degradates IN-JT333 and IN-MP819 will be converted to μmol/L using molecular weights 6



### . b) Ratios of the toxicity endpoint for parent indoxaca rb (μmol/L) to the toxicity endpoint for each degradate (μmol/L) will be calculated to y ield Toxicity Equivalence Factors (TEFs). c) Surface water EECs of parent indoxacarb and degrada tes IN-JT333 and IN-MP819 will be modeled separately. d) Surface water EECs of IN-JT333 and IN-MP819 will be adjusted based on the TEFs yielding surface water EECs for the degradates expr essed in toxic equivalents of parent. e) The surface water EEC for parent indoxacarb and sur face water EECs for degradates INJT333 and IN-MP819 expressed in toxic equivalents o f parent will be summed to yield a total surface water EEC expressed in toxic equivale nts of the parent. f) Total surface water EECs expressed in toxic equival ents of the parent will be divided by the parent’s toxicity endpoint to yield RQs. An RQ calculated using the TEQ approach represents risk from combined exposure to parent indoxacarb and degradates IN-JT333 and IN-MP819.

6 Indoxacarb MW = 527.8 g/mol; IN-JT333 MW = 468.91 g/mol; IN-MP819 MW = 498.8

### 21

Environmental fate data for IN-JT333 and IN-MP819 a re needed for modeling EECs. In the absence of data, EFED will assume these degradates are stable and use QSAR modeling (EPISuite ver. 4.0) to estimate the physical and ch emical properties needed for modeling inputs.

8.2 Measures of Exposure

There is potential for exposure to non-target organ isms through consumption of contaminated food items ( e.g., treated insects or vegetation), direct application , runoff, and spray drift. To estimate risks to non-target organisms from exposur e to indoxacarb, all exposure modeling and resulting risk conclusions will be made based on ma ximum application rates, minimum application intervals, application methods, and any mitigation measures specifically indicated on the label. Models that will be used to predict EEC s of indoxacarb are discussed on OPP’s model

website 7 

### . These models include: PRZM (P esticide R oot Z one M odel) and EXAMS (EX posure A nalysis M odeling S ystem), PRZM-groundwater (PRZM-GW), T-REX, and Terr Plant. Additionally, the Agency will assess available moni toring data.

8.3 Measures of Effect

Ecological effects data are used as measures of dir ect and indirect effects to non-target organisms. Data are obtained from registrant-submi tted studies or from open literature studies identified by ECOTOX 8 

### . Information on the potential effects of indoxaca rb and degradates to non-target organisms is also collected from reviews of incidents associated with the use of indoxacarb (see Section 5.3 ).

Where available, sub-lethal effects observed in bot h registrant-submitted and open literature studies will be evaluated qualitatively. Such effe cts may include behavioral changes ( e.g. , lethargy and changes in coloration). Quantitative assessments of risks, though, are limited to those endpoints that can be directly linked to the Agency’s assessment endpoints of impaired survival, growth, and reproduction.

The assessment of risk for direct effects to non-ta rget organisms makes the assumption that toxicity of indoxacarb to birds is similar to terre strial-phase amphibians and reptiles. The same assumption is made for fish and aquatic-phase amphi bians.

8.4 Integration of Exposure and Effects

Risk characterization is the integration of exposur e and ecological effect characterizations to determine the potential ecological risk from the us e of indoxacarb and the likelihood of direct and indirect effects to non-target organisms in aqu atic and terrestrial habitats. The exposure and effects data are integrated to evaluate potential a dverse ecological effects to non-target species. For the indoxacarb Registration Review ecological r isk assessment, the RQ method will be used to compare estimated exposure and measured toxicity values. Acute and chronic EECs will be divided by acute and chronic toxicity values. The resulting RQs will then be compared to the Agency’s LOCs (USEPA, 2004). These criteria are us ed to indicate when indoxacarb’s use, as directed on the labels, has the potential to cause adverse direct or indirect effects to non-target

7 http://www.epa.gov/pesticides/science/models_db.htm

8 http://cfpub.epa.gov/ecotox/

### 22

organisms. In addition, incident data from EIIS, a ggregate incident reports, and AIMS will be considered as part of the risk characterization.

8.5 Drinking Water Assessment

A drinking water assessment (DWA) that considers al l currently registered uses will be conducted to support the Registration Review human health dietary risk assessment for

indoxacarb. The Metabolism Assessment Review Commi ttee (MARC) of the Health Effects Division (HED) reviewed the degradate structures to determine human health residues of concern. Based on the MARC memorandum, a Total Tox ic Residue (TTR) approach should be applied for parent indoxacarb and the degradation p roducts with toxicological concern, INJT333, IN-KG433, IN- KT413, and IN-ML437-OH, for th e DWA.

Chemical concentrations will be estimated using PR ZM/EXAMS for surface waters and the Tier I model, Screening Concentration in Ground Water (S CI-GROW, v2.3), for groundwater 9



### . Alternatively, ground water concentrations may be e stimated using PRZM-GW (under evaluation) according to guidance at the time of as sessment. The DWA will also include a summary of available surface and ground water monit oring data.

8.6 Endangered Species Assessments

Consistent with the Agency’s responsibility under t he Endangered Species Act (ESA), the Agency will evaluate risks to Federally-listed thre atened and/or endangered (listed) species from registered uses of indoxacarb. This assessment wil l be conducted in accordance with the Overview Document (USEPA, 2004), provisions of the ESA, and the Services’ Endangered Species Consultation Handbook (USFWS/NMFS, 1998).

The assessment of effects associated with the regis tration of indoxacarb is based on an action

area. The action area is considered to be the area directly or indirectly affected by the federal action, as indicated by the exceedance of Agency LO Cs used to evaluate direct or indirect effects. The Agency’s approach to defining the act ion area under the provisions of the Overview Document (USEPA, 2004) considers the results of the risk assessment process to establish

boundaries for that action area with the understand ing that exposures below the Agency’s

defined LOCs constitute a no-effect threshold. For the purposes of this assessment, attention will be focused on the footprint of the action ( i.e ., the area where indoxacarb application occurs), p lus all areas where offsite transport ( i.e ., spray drift, runoff, etc .) may result in potential exposure that exceeds the Agency’s LOCs. Specific measures of ecological effect that define the action area for listed species include any direct and indi rect effects and/or potential modification of its critical habitat, including reduction in survival, growth, and reproduction as well as the full suite

of sub-lethal effects available in the effects lite rature. Therefore, the action area extends to a point where environmental exposures are below any m easured lethal or sub-lethal effect threshold for any biological entity at the whole or ganism, organ, tissue, and cellular level of organization. In situations where it is not possib le to determine the threshold for an observed effect, the action area will be assumed to encompas s the entire United States.

9 http://www.epa.gov/oppefed1/models/water/

### 23

8.7 Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerou s studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinog enicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. The se studies include endpoints which may be susceptible to endocrine influence, including effec ts on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental a nd reproductive effects in different taxonomic groups. As part of the most recent regis tration decision, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA sec tion 408(p), indoxacarb is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether cer tain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or oth er such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered appr oach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, a ndrogen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screenin g and are found to have the potential to interact with E, A, or T hormonal systems will proc eed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests a re necessary based on the available data. Tier 2 testing is designed to identify any adverse endocri ne-related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test ord ers/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingre dients and 9 inert ingredients. Indoxacarb was not among the group of 58 pesticide active ingr edients on the initial list to be screened under the EDSP. For additional information on the EDSP p rogram, visit http://www.epa.gov/endo/

.



## 9 Data Gaps

According to the Code of Federal Regulations 40 Par t 158 Subpart D (data requirements for pesticides), environmental fate and non-target orga nism effects data are required for indoxacarb based on its terrestrial use patterns. Available st udies submitted to fulfill environmental fate and ecological effects guideline requirements, as well as outstanding data gaps for indoxacarb, are

defined in Sections 9.1 and 9.2.

9.1 Environmental Fate Data

Since EFED is using the TEQ approach to assess risk to aquatic animals ( i.e. , fish and aquatic invertebrates) in the Registration Review ecologica l risk assessment, environmental fate input parameter data for IN-JT333 and IN-MP819 would faci litate the modeling of EECs. In the

### 24

absence of data, EFED will assume these degradates are stable and use QSAR modeling (EPISuite ver. 4.0) to estimate the physical and ch emical properties needed for modeling inputs.

Table 9-1 lists the status of the fate and transport data re quirements for indoxacarb. The fate database for indoxacarb is complete (with the excep tion of anaerobic soil metabolism, storage stability and analytical methods as noted in Table 9-1 ).

Table 9.1. Environmental Fate Data for Indoxacarb and Remaining Data Gaps

Guideline Description MRID Classification Data Gap? Additional Data Recommended for Request? (Risk Management Recommendations)

835.2120

161-1 Hydrolysis 44477301

45795801 Supplemental

Acceptable No --

835.2240

161-2 Photodegradation

in Water 44477302

45795802 Supplemental

Acceptable No --

835.2410

161-3 Photodegradation

in Soil 44477303 Supplemental No --

835.4100

162-1 Aerobic Soil

Metabolism 45166303

44477304

44477307

45795812

45850001

45906701

45795803 Supplemental

Marginally Acceptable Supplemental Supplemental Supplemental Acceptable 1
Acceptable 2 No --

835.4200

162-2 Anaerobic Soil

Metabolism -- -- Yes Yes. No anaerobic soil metabolism data ha ve been submitted. OCSPP guidance recommends that these tests be performed

with four soils. Because OCSPP uses an upper 90 th percentile estimate of soil

metabolism half-lives based on available study data for modeling purposes, any additional data can reduce uncertainty related to the exposure assessment as well as the half-life value used in modeling.

835.4300

162-4 Aerobic Aquatic

Metabolism 45793301

44477306 Marginally

Acceptable Supplemental No

--

835.4400

162-3 Anaerobic

Aquatic

Metabolism 45795804

44477305 Supplemental

Supplemental No --

835.1230 Adsorption/

Desorption 45795809 Supplemental 3 No --

835.1240

163-1 Leaching 44477309 Supplemental No --

835.6100

164-1 Terrestrial Field

Dissipation 45850002 Supplemental 4 No --

Storage Stability

in Soil -- -- Yes Yes. Storage Stability in soil and Analytical Methods in soil and water are required under

### 25

Guideline Description MRID Classification Data Gap? Additional Data Recommended for Request? (Risk Management Recommendations)

Analytical

Methods – Soil

and Water -- -- 40 CFR part 158 for terrestrial outdoor uses (part of Terrestrial Field Dissipation study)

165-4 Bioaccumulation

in Fish (BCF) 45805301 Acceptable No --

1 Acceptable with MRID 45795803 and MRID 44477304

2 Acceptable with MRID 44477304

3 Classified Supplemental together with study MRID 44 477308

4 Classified Supplemental together with studies MRID 44477312, 44477315, 44477316



### 9.2 Ecological Effects Data

Table 9-2 provides ecological effects studies by MRID for par ent indoxacarb ( DPX-MP062 10



### , (S) isomer KN128, and (R) isomer KN127) and degrada tes (IN-MP819, IN-JT333) that offer data for each guideline requirement, study classifi cations, whether or not there is a data gap, and

whether or not additional data are recommended for request to the support the Registration Review ecological risk assessment.

There are no data to assess chronic toxicity of IN- MP819 and IN-JT333 to freshwater fish and

invertebrates or acute and chronic toxicities of th ese degradates to estuarine/marine fish and invertebrates. In the absence of these data, these toxicity endpoints will be estimated using available toxicity data for parent indoxacarb and a cute toxicity relationships between the degradates and parent (estimates are bolded in Table 5-2 ).

10 79% (S) isomer KN128: 21% (R) isomer KN12726Table 9-2. Ecological Effects Data for Indoxacarband Remaining Data GapsGuidelineDescriptionMRIDChemicalaClassificationDataGap?Additional Data Recommended for Request?(Risk Management Recommendations)850.1010Acute toxicityfreshwaterinvertebrates44477219 DPX-MP062 AcceptableNo --4448790250% (S) isomer KN128:50% (R) isomer KN127bSupplemental46005801 IN-MP819 Acceptable No --44477221 IN-JT333 Supplemental YesNo. The study is scientifically sound but does notfulfill the guideline requirements for a freshwaterinvertebrate acute toxicity test (i.e., is classified asSupplemental) because a definitive EC50was notobtained. Five percent mortality (1 out of 20) wasobserved at the highest treatment concentration.However, it is still useful for quantitative analyses.In the absence of additional data, for the purposeofcharacterizing risk to freshwater invertebrates fromacute exposure to IN-JT333, the conservativeassumption that IN-JT333 and parent indoxacarb asDPX-MP062 (79% (S) isomer KN128: 21% (R)isomer KN127) are equally toxic to freshwaterinvertebrates will be made (i.e., EC50= 0.6 mga.i./L).850.1025850.1055Acute toxicityestuarine/marinemollusk44477224 DPX-MP062 Acceptable No --850.1035850.1045Acute toxicityestuarine/marineinvertebrate44477223 DPX-MP062 Acceptable No --850.1075Acute toxicityfreshwater fish(cold water species)44477209 DPX-MP062 AcceptableNo --4447721075% (S) isomer KN128:25% (R) isomer KN127Acceptable4447721529.3% (S) isomer KN128:10.3% (R) isomer KN127Acceptable4447721314.7% (S) isomer KN128:4.3% (R) isomer KN127Supplemental27GuidelineDescriptionMRIDChemicalaClassificationDataGap?Additional Data Recommended for Request?(Risk Management Recommendations)46022501 IN-MP819 Supplemental YesYes. The study is scientifically sound but does notfulfill the guideline requirements for a freshwaterfish acute toxicity test (i.e., is classified asSupplemental) because fish wet weight at testtermination (range of 20 fish from negative andsolvent control groups = 0.35-0.72 g) ranged lowerthan the minimum of the required initial weightrange (0.5 to 5 g). In addition, 40% mortality andsublethal effects including partial loss ofequilibrium, labored or rapid respiration, fish lyingon bottom, and lethargy were observed at the highesttreatment concentration, 0.368 mg a.i./L, resultingina non-definitive endpoint (i.e., LC50> highest testedconcentration). Based on guidance for using nondefinitive endpoints11, requesting additional data isrecommended. In the absence of additional data, theconservative assumption of an LC50of 0.368 mga.i./L may be used for characterizing risk tofreshwater fish from acute exposure toIN-MP819.44477216 IN-JT333 Acceptable NoAcute toxicityfreshwater fish(warm water species)44477211 DPX-MP062 AcceptableNo --4447721429.3% (S) isomer KN128:10.3% (R) isomer KN127Acceptable4448790150% (S) isomer KN128:50% (R) isomer KN127bSupplemental4447721250% (S) isomer KN128:50% (R) isomer KN127bSupplementalAcute toxicityestuarine/marine fish44477222 DPX-MP062 Supplemental YesYes. The study is scientifically sound but does notfulfill the guideline requirements for a freshwaterfish estuarine/marine acute toxicity test (i.e., isclassified as Supplemental) because it did not testthechemical to its maximum solubility obtainable underbrackish water conditions. In addition, 40%11http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endangered_species_reregistration_workgroup/esa_non_definitive_endpoints.htm28GuidelineDescriptionMRIDChemicalaClassificationDataGap?Additional Data Recommended for Request?(Risk Management Recommendations)mortality and sublethal effects including erraticswimming and partial loss of equilibrium wereobserved at the highest treatment concentration, 0.37mg a.i./L, resulting in a non-definitive endpoint (i.e.,LC50> highest tested concentration). Based onguidance for using non-definitive endpoints12,requesting additional data is recommended. In theabsence of additional data, the conservativeassumption of an LC50of 0.37 mg a.i./L may be usedfor characterizing risk to estuarine/marine fish fromacute exposure to parent indoxacarb.850.1300Aquatic invertebratelife cycle(freshwater)44477225 DPX-MP062 Acceptable No --850.1350Aquatic invertebratelife cycle(saltwater)44477227 DPX-MP062 Acceptable No--850.1400Fish early life stage(freshwater)44477228 DPX-MP062 Supplemental YesNo. The submitted freshwater fish early life stagetoxicity test is scientifically sound but does notfulfillthe guideline requirements for a fish early life stagetoxicity test (i.e., is classified as Supplemental) dueto the wide variability in measured concentrationsand the limited number of replicates per dose toaddress the variability. However, it is still useful forquantitative purposes. In the absence of additionaldata, the existing early life stage endpoint (i.e.,NOEC = 0.15 mg a.i./L) may be used to characterizethe toxicity of indoxacarb to freshwater fish fromchronic exposure.Fish early life-stage(saltwater)44477226 DPX-MP062 Acceptable No--850.2100Avian oral toxicity(upland game or44477201 DPW-MP062 Acceptable No--44477203 IN-JT333 Acceptable No12http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endangered_species_reregistration_workgroup/esa_non_definitive_endpoints.htm29GuidelineDescriptionMRIDChemicalaClassificationDataGap?Additional Data Recommended for Request?(Risk Management Recommendations)waterfowl species)Avian oral toxicity(passerine species)-- -- -- YesYes. Avian acute oral toxicity data for a passerinespecies are required under the new 40 CFR Part 158.Passerine birds may utilize metabolic pathways thatare different from larger birds. Data with parentindoxacarb as DPX-MP062 are recommended forrequest. In the absence of these data, passerinetoxicity data for surrogate pesticides – starting withdata for surrogate chemicals and proceeding to datafor less related chemicals – may be used tocharacterize the toxicity of indoxacarb to passerinespecies.850.2200Avian dietary toxicity(upland game species)44491701 DPW-MP062 Acceptable No --Avian dietary toxicity(waterfowl species)44477204 DPW-MP062 Acceptable No --850.2300Avian reproduction(upland game species)44477205 DPW-MP062 Acceptable No --Avian reproduction(waterfowl species)44477206 DPW-MP062 Acceptable No --850.3020Honey bee acutecontact toxicity4447723450% (S) isomer KN128:50% (R) isomer KN127bAcceptable No --850.3030Honey bee toxicity ofresidues on foliage4447723630% (S) isomer KN128:10% (R) isomer KN127Acceptable No --NonguidelineHoney bee acute oraltoxicity4447723550% (S) isomer KN128:50% (R) isomer KN127bAcceptable NA30GuidelineDescriptionMRIDChemicalaClassificationDataGap?Additional Data Recommended for Request?(Risk Management Recommendations)NonguidelineLarval honey beeacute oral toxicity-- -- -- NAYes. The “White Paper in Support of the ProposedRisk Assessment Process for Bees” as submitted tothe FIFRA Scientific Advisory Panel13proposes ascreening-level risk assessment process that includesacute contact and oral toxicity tests with adult beesand an acute oral toxicity test with larval bees.Adulthoney bee acute contact and oral toxicity data areavailable for parent indoxacarb. However, larvalhoney bee acute oral toxicity data are not.Therefore, data from a non-guideline larval honeybee acute oral toxicity test with parent indoxacarbasDPX-MP062 are recommended for request.850.4100Seedling emergence(terrestrial plants)-- -- -- YesYes. Data for terrestrial plant species are requiredunder 40 CFR Part 158. Data for a TEP with DPX-MP062 and a TEP enriched in (S) isomer KN128 arerecommended for request. In the absence of thesedata, terrestrial plant toxicity data for surrogatepesticides – starting with data for surrogatechemicals and proceeding to data for less relatedchemicals – may be used to characterize the toxicityof indoxacarb to terrestrial plants.850.4150Vegetative vigor(terrestrial plants)-- -- -- Yes850.4400Aquatic plant growth(aquatic vascular planttoxicity)44477230 DPX-MP062 Supplemental YesNo. This study is scientifically sound but does notfulfill the guideline requirements for a Tier I aquaticplant toxicity test (i.e., is classified as Supplemental)because renewals should be conducted up to dailydepending on the stability of the test material.However, it is still useful for quantitative analyses.In the absence of additional data, the existingduckweed endpoints (i.e., EC50> 0.084 mg a.i./L;NOEC = 0.084 mg a.i./L) may be used tocharacterize the toxicity of indoxacarb to aquaticvascular plants.850.4500 Aquatic plant growth 44477231 DPX-MP062 Acceptable No --13http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2012-0543-000431GuidelineDescriptionMRIDChemicalaClassificationDataGap?Additional Data Recommended for Request?(Risk Management Recommendations)(aquatic non-vascularplant: algal toxicity)44491702 DPX-MP062 Acceptable No44477232 DPX-MP062 Acceptable No850.4550Aquatic plant growth(aquatic non-vascularplant: cyanobacteriatoxicity)44477233 DPX-MP062 Acceptable No --NA = not applicable; FW = freshwater; SW = saltwateraDPX-MP062: 79% (S) isomer KN128: 21% (R) isomer KN127bDPX-JW062

### 32



## 10 References

DP 402100. Tier II Drinking Water Assessment for th e New Use Registration of Indoxacarb on Dry Beans, Snap Beans, Small Fruit Vine Climbing Su bgroup 13-07F and Low-Growing Berry Subgroup 13-07H. November 2, 2012.

DP 402424, 402425. Indoxacarb: Ecological Risk Asse ssment to Support IR-4 Proposed New Uses on Dry Beans, Snap Beans, Small Fruit Vine Cli mbing Subgroup 13-07F, and Low Growing Berry Subgroup 13-07H. January 3, 2013.

USEPA. 1998. Guidelines for Ecological Risk Asses sment. Risk Assessment Forum, Office of Research and Development, Washington, D.C. EPA/630 /R-95/002F. April 1998. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid =30759

USEPA. 2004. Overview of the Ecological Risk Asse ssment Process in the Office of Pesticide Programs. U.S. Environmental Protection Agency, Of fice of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Was hington DC. January 23, 2004.

U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS). 1998. Endangered Species Consultation Handbook: Procedur es for Conducting Consultation

and Conference Activities Under Section 7 of the En dangered Species Act. Final Draft.

March 1998.

### 33



## 11 Bibliography of Cited MRIDs

Environmental Fate Studies

44477301 Ferraro, P.; McEuen, S. (1996) Hydrolysis of DPX-JW 062 (A Racemic Mixture of

DPX-KN128 and DPX-KN127) in Buffer Solutions of pH 5, 7 and 9: Lab Project Number: AMR 2789-93. Unpublished study prepared by DuPont Agricultural Products. 39 p.

44477302 Ferraro, P.; McEuen, S. (1997) Photodegradation of DPX-JW062 (A Racemic

Mixture of DPX-KN128 and IN-KN127) in pH 5 Buffer S olution and Natural Water by Simulated Sunlight: Lab Project Number: AMR 2788 -93. Unpublished study prepared by DuPont Agricultural Products. 61 p.

44477303 Berg, D. (1997) Photodegradation of Radiolabeled DP X-JW062, A Racemic Mixture

of DPX-KN128 and IN-KN127, on Soil Under Simulated Sunlight: Lab Project Number: AMR 2818-93. Unpublished study prepared by DuPont Agricultural Products. 57 p.

44477304 Rhodes, B. (1997) Aerobic Soil Metabolism of (carbo n 14)-DPX-JW062: Lab

Project Number: AMR 2803-93. Unpublished study prep ared by DuPont Agricultural Products. 73 p.

44477305 Boucher, C. (1997) Anaerobic Aquatic Metabolism of (Indanone-1-(carbon 14))

DPX-JW062 and (Trifluoromethoxyphenyl(U)-(carbon 14 )) DPX-JW062, a Racemic (50:50) Mixture of DPX-KN128 and DPX-KN127: Lab Pro ject Number: AMR 3236-94. Unpublished study prepared by DuPont Agric ultural Products. 51 p.

44477306 McFetridge, R.; Houben, K. (1997) Degradability and Fate of DPX-JW062 in the

Aerobic Aquatic Environment (Water/Sediment System) : Lab Project Number: AMR 3523-95. Unpublished study prepared by DuPont Agric ultural Products. 63 p.

44477307 Spare, W. (1997) Aerobic Soil Metabolism of DPX-MP0 62, An (Approximately) 3:1

Mixture of DPX-KN128 and IN-KN127: Lab Project Numb er: 1748: 3633-95. Unpublished study prepared by Agrisearch, Inc. 72 p

.

44477309 Fetterman, D.; Chrzanowski, R. (1997) Soil Column L eaching Study of (carbon 14)-

DPX-MP062 (A 3:1 Mixture of DPX-KN128 and IN-KN127) on Four Aged Soils: Lab Project Number: AMR 3845-96. Unpublished study prepared by DuPont Agricultural Products. 85 p.

44477311 Ruhl, J. (1997) Field Soil Dissipation of (carbon 1 4)DPX-JW062 (Racemic Mixture

of DPX-KN128 and IN-KN127) Following Application of DPX-JW062 Experimental Insecticide: Revision No. 1: Lab Proje ct Number: 42635: AMR 3400- 95. Unpublished study prepared by DuPont Agricultur al Products and Analytical Bio-Chemistry Labs., Inc. 299 p.

44477312 Vincent, D.; McCooey, K.; Ruhl, J. (1997) Field Soi l Dissipation of DPX-JW062

(Racemic Mixture of DPX-KN128 (Insecticidally Activ e Enantiomer) and INKN127) Following Application of DPX-JW062 Experimen tal Insecticide to Bare

### 34 Ground: Lab Project Number: AMR 3402-95: ML95-0571- DUP. Unpublished study prepared by DuPont Agricultural Products and Morse Labs., Inc. 338 p.

44477315 Klemens, F.; Ehlers, C.; Harris, E. (1997) Environm ental Chemistry Method for the

Determination of DPX-KN128/IN-KN127 Residues in Wat er Using GC/ECD: Lab Project Number: AMR 3052-94. Unpublished study prep ared by Conoco, Inc. and DuPont Agricultural Products. 27 p.

44477316 Westberg, G.; Vincent, D. (1997) Environmental Chem istry Method for the

Determination of DPX-KN128 Residues in Soil Using G C-MSD: Revision No. 1: Lab Project Number: AMR 4367-97. Unpublished study prepared by DuPont Agricultural Products. 40 p.

44477319 Premkumar, N.; Cole, K.; Madsen, T. (1997) Bioconce ntration and Metabolism of

(Indanone-1-(carbon 14))DPX-JW062 and (Trifluoromet hoxyphenyl(U)-(carbon 14))DPX-JW062 in Fish (A Racemic Mixture of DPX-KN1 28 and IN-KN127): Lab Project Number: 42910: AMR 3663-95. Unpublished stu dy prepared by ABC Labs., Inc. 270 p.

45166303 Rhodes, B. (1997) Degradation Rates of DPX-MP062 in Soil: Lab Project Number:

AMR 4251-96. Unpublished study prepared by E.I. du Pont de Nemours and Company. 64 p.

45793301 Shaw, D. (2002) (Carbon 14)-DPX-MP062 (A 3:1 Mixtur e of DPX-KN128 and INKN127): Degradability and Fate in the Water/Sedimen t System: Lab Project Number: DUPONT-8417: 8417: DPT 617/023294. Unpublis hed study prepared by Huntingdon Life Sciences Ltd. 153 p.

45795801 Lentz, N. (2002) Hydrolysis of (Carbon 14)-DPX-MP06 2 in Buffer Solutions of pH

5, 7, and 9: Lab Project Number: 014331-1: DUPONT-9 800: 014331. Unpublished study prepared by Ricerca Biosciences, LLC. 70 p.

45795802 Lentz, N. (2002) Photodegradation of (Carbon 14)-DP X-MP062 in pH 5 Buffer by

Simulated Sunlight: Lab Project Number: 014330-1: D UPONT-9801. Unpublished study prepared by Ricerca Biosciences, LLC. 86 p.

45795803 Singles, S.; Rhodes, B. (2002) Aerobic Soil Metabol ism of (Carbon 14)-DPXJW062: Revision 1: Lab Project Number: AMR 2803-93. Unpublished study prepared by E.I. DuPont de Nemours and Company. 104 p.

45795804 Smyser, B. (2002) Anaerobic Aquatic Metabolism of ( Indanone-1-(Carbon 14))

DPX-JW062 and (Trifluoromethoxyphenyl(U)-(Carbon 14 )) DPX-JW062, A Racemic (50:50) Mixture of DPX-KN128 and IN-KN127: Lab Project Number: AMR 3236-94: 02-CPS-013: 02. Unpublished study prep ared by E.I. du Pont de Nemours and Company and Critical Path Services, LLC . 72 p.

45795809 Smyser, B. (2002) Batch Equilibrium Study of DPX-JW 062 (A Racemic Mixture of

DPX-KN128 and IN-KN127) and IN-JT333: Lab Project N umber: AMR 3489-95. Unpublished study prepared by E.I. du Pont de Nemou rs and Company and Critical Path Services, LLC. 65 p.

### 35

45795812 Rhodes, B. (2002) Degradation Rates of DPX-MP062 in Soil: Lab Project Number:

AMR 4251-96: 02-CPS-012. Unpublished study prepared by E.I. du Pont de Nemours and Company and Critical Path Services, LLC . 28 p.

45805301 Premkumar, N.; Cole, K.; Madsen, T.; et al. (2002) Bioconcentration and

Metabolism of (Indanone-1-(Carbon 14))DPX-JW062 and (Trifluoromethoxyphenyl(U)-(Carbon 14))DPX-JW062 in Fish (A Racemic Mixture of DPX-KN128 and IN-KN127): Revision 1: Lab Project Number: AMR 3663-95: 42910: 42910-B1. Unpublished study prepared by E.I. duPont de Nemours and Company and ABC Laboratories, Inc. 258 p.

45850001 Spare, W. (2002) Aerobic Soil Metabolism of DPX-MP0 62, AN=3:1 Mixture of

DPX-KN128 and IN-KN127: Lab Project Number: AMR 363 3-95. Unpublished study prepared by Agrisearch Incorporated and E.I. du Pont de Nemours and Company. 16 p.

45850002 Vincent, D.; McCooey, K.; Ruhl, J. (1999) Field Soi l Dissipation of DPX-JW062

(Racemic Mixture of DPX-KN128 (Insecticidally Activ e Enantiomer) and INKN127) Following Application of DPX-JW062 Experimen tal Insecticide to Bare Ground: Lab Project Number: AMR 3402-95: ML95-0571- DUP. Unpublished study prepared by E.I. du Pont de Nemours and Company and Morse Laboratories, Inc. 107 p. {OPPTS 860.1380}

45906701 Mellor, S. (2003) (Carbon 14)-DPX-MP062 (A 3:1 Mixt ure of DPX-KN128 and INKN127): Aerobic Soil Metabolism: Lab Project Number : DUPONT-8516: 8516. Unpublished study prepared by Huntingdon Life Scien ces Ltd. 108 p.

Ecological Effects Studies

44477113 Sarver, J. (1996) Acute Oral Toxicity Stud y with DPX-MP062 Technical

(Approximately 75% DPX-KN128, 25% DPX-KN127) in Mal e and Female Rats: Lab Project Number: 10581-001: HLR 910-96: 910-96. Unpublished study prepared by Haskell Laboratory for Toxicology and Industrial Medicine. 56 p.

44477115 Kern, T. (1997) Acute Oral Toxicity Study with DPX-KN128 Technical in Male

and Female Rats: Final Report: Lab Project Number: 10720-001: HLO-1997-00055: WIL-189093. Unpublished study prepared by WIL Resea rch Labs., Inc. 123 p.

44477116 Kern, T. (1997) Acute Oral Toxicity Study with IN-KG433 Technical in Male and

Female Rats: Final Report: Lab Project Number: 1120 2-001: HLO-1997-00469: WIL-189109. Unpublished study prepared by WIL Resea rch Labs., Inc. 81 p.

44477117 Sarver, J. (1996) Acute Oral Toxicity Stud y with IN-JT333 in Male and Female

Rats: Final Report: Lab Project Number: 10578-001: 927-96: HLR 927-96. Unpublished study prepared by WIL Research Labs., I nc. 68 p.

44477129 MacKenzie, S. (1997) Subchronic Oral Toxic ity: 90-Day Study with DPX-MP062

(Approximately 75% DPX-KN128, 25% DPX-KN127) Feedin g Study in Rats: Revision No. 1: Lab Project Number: 10668-001: DUPO NT HL-1997-00056.

### 36 Unpublished study prepared by Haskell Lab. for Toxi cology and Industrial Medicine. 462 p.

44477132 Malek, D. (1997) Subchronic Oral Toxicity: 90-Day Study with DPX-JW062-69

(99.7% DPX-KN128) Feeding Study in Rats: Revision N o. 1: Lab Project Number: 9793-001: DUPONT HLR 301-94: 301-94. Unpublished st udy prepared by Haskell Lab. for Toxicology and Industrial Medicine. 552 p.

44477139 Munley, S. (1997) Developmental Toxicity Study of D PX-JW062-106 in Rats:

Revision No. 1: Lab Project Number: 9961-001: DUPON T HLR 558-95: 558-95. Unpublished study prepared by Haskell Lab. for Toxi cology and Industrial Medicine. 206 p.

44477201 Palmer, S.; Grimes, J.; Beavers, J. (1997) DPX-MP062 Technical (Approximately

75% DPX-KN128, 25% DPX-KN127): An Acute Oral Toxici ty Study With the Northern Bobwhite: Amended Report: Lab Project Numb er: AMR 3940-96: 112- 432: 112/042996/QLD.NC/SUB112. Unpublished study pr epared by Wildlife International Ltd. 59 p.

44477203 Palmer, S.; Beavers, J. (1997) IN-JT333-20 : An Acute Oral Toxicity Study With the

Northern Bobwhite: Lab Project Number: 112-431: 389 0-96: 112/031996/QLD.NC/SUB112. Unpublished study prepare d by Wildlife International Ltd. 47 p.

44477204 Palmer, S.; Beavers, J.; Grimes, J. (1997) DPX-MP062 Technical (Approximately

75% DPX-KN128, 25% DPX-KN127): A Dietary LC50 Study With the Mallard: Amended Report: Lab Project Number: AMR 4093-96: 11 2-438: 112/073096/MLCSDT.WC/SUB112. Unpublished study prep ared by Wildlife International Ltd. 49 p.

44477205 Frey, L.; Beavers, J.; Jaber, M. (1997) DP X-MP062 Technical (Approximately 75%

DPX-KN128, 25% DPX-KN127): A Reproduction Study Wit h the Northern Bobwhite ( Colinus virginianus ): Amended Report: Lab Project Number: AMR 4096-96: 112-441: 112/073096/QR.WC/SUB112. Unpublis hed study prepared by Wildlife International Ltd. 210 p.

44477206 Frey, L.; Beavers, J.; Jaber, M. (1997) DP X-MP062 Technical (Approximately 75%

DPX-KN128, 25% DPX-KN127): A Reproduction Study Wit h the Mallard ( Anas platyrhynchos ): Amended Report: Lab Project Number: AMR 4095-96: 112-442: 11018. Unpublished study prepared by Wildlife Inter national Ltd. 206 p.

44477209 Hoke, R. (1997) DPX-MP062 (Approximately 7 5% DPX-Kn128, 25% IN-KN127):

Flow-through, Acute, 96-Hour LC50 to Rainbow Trout, Oncorhynchus mykiss : Revision No. 2: Lab Project Number: 911-96: 10769-0 01. Unpublished study prepared by E. I. du Pont de Nemours & Company. 39 p.

44477210 Hoke, R. (1997) DPX-MP062 (Approximately 7 5% DPX-KN128, 25% IN-KN127):

Flow-through, Acute, 96-Hour LC50 to Bluegill Sunfi sh, Lepomis macrochirus : Revision No. 2: Lab Project Number: 912-96: 10769-0 01. Unpublished study prepared by E. I. du Pont de Nemours & Company. 37 p.

### 37

44477211 Hoke, R. (1997) DPX-MP062 (Approximately 7 5% DPX-KN128, 25% IN-KN127):

Flow-through, Acute, 96-Hour LC50 to Channel Catfis h, Ictalurus punctatus : Revision No. 2: Lab Project Number: 866-96: 10769-0 01. Unpublished study prepared by E. I. du Pont de Nemours & Company. 36 p.

44477212 Brown, M. (1997) DPX-JW062-106 (Racemic Mi xture of DPX-KN128 and DPXKN127): Flow-through, Acute, 96-Hour LC50 to Carp, Cyprinus carpio : Lab Project Number: 879-96: 10125. Unpublished study pr epared by E.I. du Pont de Nemours & Company. 44 p.

44477213 Grube, P. (1997) DPX-MP062 150SC: Static-R enewal, Acute, 96-Hour LC50 to

Rainbow Trout, Oncorhynchus mykiss : Lab Project Number: HL-1997-00654: 10721. Unpublished study prepared by E. I. du Pont de Nemours & Company. 35 p.

44477214 Kreamer, G. (1997) DPX-MP062 30WG: Static- Renewal, Acute, 96-Hour LC50 to

Bluegill Sunfish, Lepomis macrochirus : Lab Project Number: HL-1997-00025: 11374. Unpublished study prepared by E. I. du Pont de Nemours & Company. 36 p.

44477215 Kreamer, G. (1997) DPX-MP062 30WG: Static- Renewal, Acute, 96-Hour LC50 to

Rainbow Trout, Oncorhynchus mykiss: Lab Project Number: HL-1997-00508: 11374. Unpublished study prepared by E. I. du Pont de Nemours & Company. 35 p.

44477216 Hoke, R. (1997) IN-JT333-20: Flow-through, Acute, 96-Hour LC50 to Rainbow

Trout, Oncorhynchus mykiss : Lab Project Number: HL-1997-00180: 10584. Unpublished study prepared by E. I. du Pont de Nemo urs & Company. 33 p.

44477218 Hoke, R. (1997) IN-KN127 Technical: Flow-t hrough, Acute, 96-Hour LC50 to

Rainbow Trout, Oncorhynchus mykiss : Lab Project Number: HLR 990-96: 11019. Unpublished study prepared by E. I. du Pont de Nemo urs & Company. 34 p.

44477219 Hoke, R. (1997) DPX-MP062 (Approximately 7 5% DPX-KN128, 25% IN-KN127):

Static, Acute, 48-Hour EC50 to Daphnia magna : Revision No. 2: Lab Project Number: HLR 603-96: 10769-001: Unpublished study pr epared by E. I. du Pont de Nemours & Company. 34 p.

44477221 Hoke, R. (1997) IN-JT333-20: Static-Renewa l, Acute, 48-Hour EC50 to Daphnia

magna : Lab Project Number: HL-1997-00006: 10584. Unpubli shed study prepared by E. I. du Pont de Nemours & Company. 33 p.

44477222 Boeri, R.; Magazu, J.; Ward, T. (1997) Flo w-Through Acute Toxicity of DPXMP062 to the Sheepshead Minnow, Cyprinodon variegatus : Revision No. 1: Lab Project Number: HLO-1997-00090: 802-DU: HA-96-064. Unpublished study prepared by T.R. Wilbury Labs., Inc. 58 p.

44477223 Boeri, R.; Magazu, J.; Ward, T. (1997) Flo w-Through Acute Toxicity of DPXMP062 to the Mysid, Mysidopsis bahia : Revision No. 1: Lab Project Number: HLO-1997-00205: 803-DU: 10769. Unpublished study pr epared by T.R. Wilbury Labs., Inc. 57 p.

44477224 Boeri, R.; Magazu, J.; Ward, T. (1997) Acu te Flow-Through Mollusc Shell

Deposition Test With DPX-MP062: Revision No. 1: Lab Project Number: HLO-

### 38 1997-00350: 10769: 10586. Unpublished study prepare d by T.R. Wilbury Labs., Inc. 59 p.

44477225 Hoke, R. (1997) DPX-MP062 (Approximately 7 5% DPX-KN128, 25% IN-KN127):

Chronic Toxicity to Daphnia magna : Lab Project Number: HL-1997-00912. Unpublished study prepared by E.I. du Pont de Nemou rs & Company. 81 p.

44477226 Boeri, R.; Magazu, J.; Ward, T. (1997) Ear ly Life Stage Toxicity of DPX-MP062 to

the Sheepshead Minnow, Cyprinodon variegatus : Revision No. 1: Lab Project Number: HLO-1997-00091: 10769: 806-DU. Unpublished study prepared by T.R. Wilbury Labs., Inc. 72 p.

44477227 Boeri, R.; Magazu, J.; Ward, T. (1997) Chr onic Toxicity of DPX-MP062 to the

Mysid, Mysidopsis bahia : Revision No. 1: Lab Project Number: HLO 1997-0020 6: 10769: 805-DU. Unpublished study prepared by T.R. W ilbury Labs., Inc. 77 p.

44477228 Hoke, R. (1997) DPX-MP062 (Approximately 7 5% DPX-KN128, 25% IN-KN127):

Early Life-Stage Toxicity to Rainbow Trout, Oncorhynchus mykiss : Revision No. 1: Lab Project Number: HLR-598-96: 10769-001. Unpublis hed study prepared by E. I. du Pont de Nemours & Company. 141 p.

44477230 Sloman, T.; Leva, S. (1997) DPX-MP062 (Con sisting of 75% DPX-KN128 and

25% DPN-KN127): Influence on Growth and Reproductio n of Lemna gibba G3: Revision #1: Lab Project Number: AMR 3602-95: MR 10 616. Unpublished study prepared by E. I. du Pont de Nemours & Company. 38 p.

44477231 Hughes, J.; Williams, T.; Conder, L. (1997 ) DPX-MP062-51A (Approximately 75%

DPX-KN128, 25% DPN-KN127): Influence on Growth and Reproduction of

Skeletonema costatum (Revision 2): (Final Report): Lab Project Number: 3771-96: 19-04-3: HA-96-064. Unpublished study prepared by C arolina Ecotox, Inc. 99 p.

44477232 Hughes, J.; Williams, T.; Conder, L. (1997 ) DPX-MP062-51A (Approximately 75%

DPX-KN128, 25% IN-KN127): Influence on Growth and R eproduction of Navicula pelliculosa (Revision 2): (Final Report): Lab Project Number: 19-04-2: 3772-96: HA-96-064. Unpublished study prepared by Carolina E cotox, Inc. 87 p.

44477233 Hughes, J.; Williams, T.; Conder, L. (1997 ) DPX-MP062-51A (Approximately 75%

DPX-KN128, 25% IN-KN127): Influence on Growth and R eproduction of Anabaena flos-aquae (Revision 2): (Final Report): Lab Project Number: AMR 3770-96: 19-04-1: HA-96-064. Unpublished study prep ared by Carolina Ecotox, Inc. 87 p.

44477234 Palmer, S.; Beavers, J. (1994) DPX-JW062-4 7: An Acute Contact Toxicity Study

With the Honey Bee: Final Report: Lab Project Numbe r: 112-361: 277-94: 9699- 001. Unpublished study prepared by Wildlife Interna tional Ltd. 17 p.

44477235 Palmer, S.; Beavers, J. (1994) DPX-JW062-4 7: An Dietary LC50 Toxicity Study

With the Honey Bee: Final Report: Lab Project Numbe r: 112-360: 276-94: 9699- 001. Unpublished study prepared by Wildlife Interna tional Ltd. 16 p.

44477236 Palmer, S.; Beavers, J.; Priester, T. (199 7) DPX-MP062-58 30 WG Formulation

### 39 Containing 30% (W/W) DPX-KN128: Honey Bee Toxicity of Residues on Alfalfa Foliage: Revision No. 1: Amended Report: Lab Projec t Number: AMR 3866-96: 112-435. Unpublished study prepared by Wildlife Int ernational Ltd. and McKenzie Labs., Inc. 98 p.

44487901 Watari, N. (1993) Acute Toxicity Study of JW062 Technical Using Carp: Lab

Project Number: 2706: 2232 (055-057). Unpublished s tudy prepared by Biosafety Research Center. 16 p.

44487902 Watari, N. (1993) Acute Toxicity Study of JW062 Technical Using Daphnia : Lab

Project Number: 2707: 2233 (055-058). Unpublished s tudy prepared by Biosafety Research Center. 13 p.

44491701 Palmer, S.; Grimes, J.; Beavers, J. (1997) DPX-MP062 Technical (Approximately

75% DPX-KN128, 25% DPX-KN127): A Dietary LC50 Study with the Northern Bobwhite: Amended Report: Lab Project Number: AMR 4 094-96: 112-437: 112/073096/QLCSDT.WC/SUB112. Unpublished study prep ared by Wildlife International Ltd. 51 p.

44491702 Sloman, T.; Leva, S. (1997) DPX-MP062 (Con sisting of 75% DPX-KN128 and

25% IN-KN127): Influence on Growth and Growth Rate of the Green Alga Pseudokirchneriella subcapitata (Formerly Selenastrum capricornutum ): Lab Project Number: AMR 4273-96: MR 11197. Unpublished study prepared by DuPont Stine-Haskell Research Center. 45 p.

46005801 Samel, A. (2003) IN-MP819: Flow-Through, A cute, 48-Hour EC50 to Daphnia

magna. Project Number: 14339, 308, DUPONT/11491. Un published study prepared by E. I. du Pont de Nemours and Co. 37 p.

46022501 Samel, A. (2003) IN-MP819: Flow-Through, A cute, 96-Hour LC50 to Rainbow

Trout, Oncorhynchus mykiss . Project Number: DUPONT/11492, 11492, 14339. Unpublished study prepared by DuPont Haskell Labora tory. 35 p.40Appendix A: Indoxacarb’s Degradation ProfileCode Name/SynonymChemical NameChemical StructureStudy TypeMRIDMaximum Formation(% Applied)IN-KT413CAS Name:sodium 7-chloro-2,5,-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-e][l,3,4]oxadiazine-4a(3H)-carboxylic acidMolecular Weight:513.82 g/mol(free acid)Hydrolysis4447730148.0Hydrolysis pH 74579580147.1Hydrolysis pH 988.1Aerobic Aquatic Metabolism4579330142.1Anaerobic Aquatic Metabolism4447730516.0IN-MF014CAS Name:methyl 2-[[[4-(trifluoromethoxy)phenyl]amino ]carbonyl]hydrazinecarboxylateHydrolysis pH 5457958016.1Hydrolysis pH 714.7Aqueous Photolysis 4447730237.8Aqueous Photolysis 4579580237.6IN-MH304CAS Name:Not ReportedAqueous Photolysis 4447730219.941Code Name/SynonymChemical NameChemical StructureStudy TypeMRIDMaximum Formation(% Applied)Aqueous Photolysis 4579580232.3MW 297CAS Name:Not ReportedProposed structure; not proven due to inabilityto synthesize standardAqueous Photolysis 4447730214.1IN-KB687CAS Name:methyl[4(trifluoromethoxy)phenyl]carbamateMolecular Weight:235.16 g/molAqueous Photolysis 4447730222.1Aqueous Photolysis 4579580228.7Soil Photolysis 4447730322.0Aerobic Soil Metabolism 4447730411.0IN-C0639CAS Name:4-chloro-1,2-benzenedicarboxylicacidAqueous Photolysis 4579580210.2IN-MA573CAS Name:2-carboxy-5-chloro benzeneaceticacidAqueous Photolysis 4579580219.9IN-JT333CAS Name:methyl-7-chloro-2,5-dihydro -2-[[[4(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2e][1,3,4]oxadiazine -4a(3H)-carboxylateAerobic Soil Metabolism 4590670118.6Aerobic Aquatic Metabolism 4447730610.542Code Name/SynonymChemical NameChemical StructureStudy TypeMRIDMaximum Formation(% Applied)Molecular Weight:469.81 g/molAerobic Aquatic Metabolism 4579330125.7Anaerobic Aquatic Metabolism 4447730528.2IN-KG433CAS Name:Methyl-5-chloro-2,3-dihydro-2-hydroxy-1[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]hydrazono]-1H-indene-2-carboxylateMolecular Weight:515.83 g/molAerobic Soil Metabolism 4516630339.7IN-JU873CAS Name:1-[[[[4-(trifluoromethoxy)phenyl]amino] carbonyl]hydrazono]-1Hindene-2-carboxylateMolecular Weight:457.8 g/molAerobic Soil Metabolism 4516630312.943Code Name/SynonymChemical NameChemical StructureStudy TypeMRIDMaximum Formation(% Applied)IN-ML438CAS Name:7-chloro-2,4-dihydro-4-[4-4 -(trifluoromethoxy)phenyl]-3Hindeno[2,1-e]-1,2,4-triazin-3-oneMolecular Weight:379 g/molAerobic Soil Metabolism 451663039.7IN-MK643CAS Name:l,2-dihydro-5-(trifluoromethoxy)-2H-benzimidazol-2-oneMolecular Weight:218.14 g/molAerobic Soil Metabolism 451663034447730412.0IN-MK638CAS Name:[4-(trifluoromethoxy)phenyl)ureaMolecular Weight:220 g/molAerobic Soil Metabolism 4516630328.1IN-ML437-OHCAS Name:Not ReportedAerobic Soil Metabolism 4447730413.044Code Name/SynonymChemical NameChemical StructureStudy TypeMRIDMaximum Formation(% Applied)IN-MP819CAS Name:lndenol[1 ,2-e][1 ,3,4]oxadlazine-1(2H)-carboxylic acid, 7-chloro-3,5-dlhydno-2-[[[4-(triftuoromethoxy)phenyl]amino]carbonyl]-, methyl esterMolecular Weight:469.8 g/molAerobic Aquatic Metabolism 4579330110.3IN-MS775CAS Name:7-Chloro-4a,5-dihydro-N-(4-(trifluoromethoxy)phenyl]idenol[1,2-e][1 ,3,4]oxadiazine-2(3H)-carboxamideMolecular Weight:411.8 g/molAerobic Aquatic Metabolism 4579330112.8Unknown AUnidentifiedAerobic Aquatic Metabolism 4447730624.1CO2Carbon DioxideO=C=OAerobic Soil Metabolism 4579580335.7Aerobic Aquatic Metabolism 4447730619.0Aerobic Aquatic Metabolism 4579330125.8UnextractableResiduesAerobic Soil Metabolism 4590670166.1

### 45



## Appendix B: SIP (v 1.0) Inputs and Results

The purpose of this model is to provide an upper bo und estimate of exposure of birds and mammals to pesticides through drinking water alone. This model is intended for use in problem formulation to determine whether or not drinking water exposure al one is a potential pathway of concern. This does no t aggregate drinking water exposure with other exposu re routes (i.e., diet, inhalation, dermal).

Assumptions:

SIP employs the following conservative assumptions to derive upper bound exposure estimates:

1) The chemical concentration in drinking water is at the solubility limit in water (at 25 o C).
2) The assessed animals obtain 100% of their daily water needs through drinking water. 3) The daily water need is equivalent to the daily water flux rate as calculated by Nagy and Peterson (1988). 4) The body weight of the assessed bird is equivale nt to the smallest generic bird modeled in T-REX (i .e., 20 g). This assumption results in the highest ratio of exposure to toxicity for the 3 assessed avian b ody weights of T-REX (i.e., 20, 100, 1000 g).

5) The body weight of the assessed mammal is equiva lent to the largest generic mammal modeled in TREX (i.e., 1000 g). This results in the highest rat io of exposure to toxicity for the 3 assessed mamma lian body weights of T-REX (i.e., 15, 35, 1000 g).

Table 1. Inputs

Parameter Value

Chemical name Indoxacarb
Solubility (in water at 25 o C; mg/L) 0.8

Mammalian LD 50 (mg/kg-bw) 179 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg-bw) 0.4 8 mg/kg-diet/20
Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg-bw) 98
Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg-diet) 720 Bobwhite quail NOAEC (mg/kg-diet) 144 NOAEC (mg/kg-diet) for other bird species Body weight (g) of other avian species NOAEC (mg/kg-diet) for 2nd other bird species Body weight (g) of 2nd other avian species

### 46

Table 2. Mammalian Results

Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 0.1376 0.1376 Adjusted toxicity value (mg/kg-bw) 137.6797 0.3077 Ratio of exposure to toxicity 0.0010 0.4472

Conclusion* Drinking water exposure alone is NOT a potential

concern for mammals Drinking water exposure alone is NOT a potential

concern for mammals

Table 3. Avian Results

Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 0.6480 0.6480 Adjusted toxicity value (mg/kg-bw) 70.6021 15.3070 Ratio of exposure to acute toxicity 0.0092 0.0423

Conclusion* Drinking water exposure alone is NOT a potential

concern for birds Drinking water exposure alone is NOT a potential

concern for birds

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure th rough drinking water may contribute to a total exposure t hat has potential for effects to non-target animals

.

### 47



## Appendix C: STIR (v 1.0) Inputs and Results



# Welcome to the EFED Screening Tool for Inhalation Risk

This tool is designed to provide the risk assessor with a rapid method for determining the potential significance of the inhalation exposure route to bi rds and mammals in a risk

assessment. 

# Input

Application and Chemical Information

Enter Chemical Name indoxacarb

Enter Chemical Use Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air Enter Chemical Molecular Weight (g/mole) 275.8 Enter Chemical Vapor Pressure (mmHg) 1.90E-10 Enter Application Rate (lb a.i./acre) 0.1125

Toxicity Properties

Bird

Enter Lowest Bird Oral LD 50 (mg/kg bw) 98 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178

Mammal

Enter Lowest Rat Oral LD 50 (mg/kg bw) 179

Enter Lowest Rat Inhalation LC 50 (mg/L) 5.5 Non-definitive ( i.e. , >) Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35 

# Output

Results Avian (0.020 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.82E-06 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 3.54E-07

Adjusted Inhalation LD 50 1.68E+01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 2.11E-08 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg ) 1.08E-02 Ratio of Droplet Inhalation Dose to Adjusted Inhala tion

LD 50 6.44E-04 Exposure not Likely Significant Maximum 1-hour Vapor Inhalation Dose (mg/kg) 4.46E-07

Adjusted Inhalation LD 50 3.27E+02

Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.36E-09 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg ) 1.36E-02

Ratio of Droplet Inhalation Dose to Adjusted Inhala tion 4.15E-05 Exposure not Likely

### 48

LD 50 Significant



# Welcome to the EFED Screening Tool for Inhalation Risk

This tool is designed to provide the risk assessor with a rapid method for determining the potential significance of the inhalation exposure route to bi rds and mammals in a risk

assessment. 

# Input

Application and Chemical Information

Enter Chemical Name indoxacarb

Enter Chemical Use Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 275.8 Enter Chemical Vapor Pressure (mmHg) 1.90E-10 Enter Application Rate (lb a.i./acre) 0.1125

Toxicity Properties

Bird

Enter Lowest Bird Oral LD 50 (mg/kg bw) 98 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178

Mammal

Enter Lowest Rat Oral LD 50 (mg/kg bw) 179

Enter Lowest Rat Inhalation LC 50 (mg/L) 5.5 Non-definitive ( i.e. , >) Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35



# Output

Results Avian (0.020 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.82E-06 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 3.54E-07

Adjusted Inhalation LD 50 1.68E+01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 2.11E-08 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg ) 1.19E-02 Ratio of Droplet Inhalation Dose to Adjusted Inhala tion

LD 50 7.08E-04 Exposure not Likely Significant



### Results Mammalian (0.015 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.82E-06 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 4.46E-07

### 49

Adjusted Inhalation LD 50 3.27E+02

Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.36E-09 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg ) 1.49E-02 Ratio of Droplet Inhalation Dose to Adjusted Inhala tion

LD 50 4.56E-05 Exposure not Likely Significant