OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460



### PC Code : 090205

DP Barcode: 406269 , 410639

November 12

, 2013

MEMORANDUM

SUBJECT: Environmental Fate and Ecological Risk Assessment for the Section 3 New Chemical Registration of Ethaboxam

TO: Tony Kish

, Risk Manager

Dominic Schuler

, Risk Manager Reviewer Registration Division ( 7505P )

FROM: Elizabeth Riley, Biologist Andrew Shelby , Environmental Scientist

Mark Corbin , Branch Chief

Environmental Risk Branch VI Environmental Fate and Effects Division (7507P)

The Environmental Fate and Effects Division (EFED) has completed the screening level

asses sment of the environmental fate and ecological risks of the proposed new chemical

ethaboxam ( V

- 10208 3.2 Fungicide , PC Code 090205 ). This assessment is for a national registration request for the following uses: legume vegetables (except cowpea and field p ea), cereal grains (except rice and wild rice), and the rapeseed subgroup

. This assessment applies to the proposed ethaboxam end

- use product, V

- 10208 3.2 Fungicide

, for use as a seed treatment and will not be applicable to proposed foliar uses.

Summary o f Risk Conclusions

The results of this screening

- level assessment on the proposed ethaboxam seed treatment uses indicate that risks of adverse effects to non

- target organisms are not expected for aquatic and terrestrial plants and animals . These results are summarized in the body of the document in

Section 1.2.

Uncertainties

Submitted environmental fate studies represent application methods relevant to broadcast applications rather than seed treatments, the use pattern relevant to this new chemical- Page 2 of 68

- 

### registration. The formulation applied to the seed and interaction with the seed coat can impact the degradation and mobility of ethaboxam. In the absence of field or laboratory data demonstrating ethaboxam fate and transport on seed treatmen ts, the rate and route of ethaboxam dissipation are uncertainities.

Major degradates of ethaboxam are structurally similar to ethaboxam and are conservatively assumed to be toxic residues. Degradation estimates cannot be made because concentrations of degradate increase to study termination. An aged column leaching study indicates that degradates can leach through soil but further characterization of degradate mobility is not possible without further data. In the absence of specific degradate fate and transport data, the rate and route of ethaboxam degradate dissipation are uncertainties.

Submitted metabolism studies use only an acetone extraction and unextracted residues in aerobic soil metabolism studies are 55% to 70% of applied radioactivity by st udy termination. Without demonstrating additional extractions, the bioavailability of these unextracted residues is an uncertainty. An aerobic soil metabolism study employing additional extraction techniques is being submitted and preliminary results ind icate lower unextracted residues. The results of this study ha ve potential to reduce uncertainity associated with the unextracted residues.

Data Gaps



### 835.4100 Aerobic Soil Metabolism

– Currently submitted studies do not deomonstrate sufficient attempts to extracted unextracted residue. The registrant has indicated a new aerobic soil metabolism study with more exhaustive extraction techniques has been conducted but the study has not yet been submitted.

835.6100 Terrestrial Field Dissipation

– The registrant maintains that detection limits are not sufficient to conduct a terrestrial field dissipation study at current labeled rates for this seed

treatment . The study remains a data gap pending improved detection limits.

850.1350 Estuarine/Ma rine Invertebrate Chronic Toxcicity

– An acceptable chronic toxicity study with an estuarine/marine invertebrate species is not available. In the absence of the data an

an acute

- to

- chronic ratio (ACR) based on the daphnid is applied. The ACR is considered protective for the purpose of this risk assessment; however, the application of an ACR in the absence of actual data does introduce uncertainty to the risk assessment.

850.4100 Terrestrial Plant Seedling Emergence

– The registrant submitted data waiver

re quests for both the seedling emergence (MRID 48535704), citing ethaboxam’s low field application rates as a seed treatment, relatively rapid soil half

- life (1.5 to 6.1 days depending on the soil), and fungicidal mechanism of action. While the Agency did n ot grant the waiver request for the seedling emergence data because ethaboxam is chemically active during seed germination and may be transmitted off

- site via run

- off, supporting data provided by the registrant on seed germination in the presence of ethabo xam (memo data 10/15/2012) suggest that the relatively low application rate of ethaboxam as a seed treatment does not inhibit seed germination. However, both seedling emergence and vegetative vigor data would be necessary should the registrant submit a fu ture registration request for an above

- ground spray application of

ethaboxam.- Page 3 of 68

- 

### 850.4400/5400 Vascular and Non

- Vascular Aquatic Plant Toxicity

– CFR 40 Part 158 requires toxicity tests using four species of non

- vascular plants and one species of vascular plant. Currently, data have only been submitted for one species of non

- vascular plant. Additional data located on the Footprint database suggest that ethaboxam has highly variable toxicity to aquatic

non

- vascular species. While exposure from the seed treat ment use is low, data for additional species of non

- vascular plants should be submitted.- Page 4 of 68

- 

# Environmental Fate and Ecological Risk Assessment for the Registration of Ethaboxam

Ethaboxam

N

- (cyano

- 2

- thienylmethyl)

- 4

- ethyl

- 2

- (ethylamino)

- 5

- thiazolecarboxamide CAS Registry Number : 162650

- 77

- 3

PC Code : 090205

Prepared by:
Elizabeth A. Riley , Biologist Andrew Shelby

, Environmental Scientist
U. S. Environmental Protection Agency Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch IV

1200 Pennsylvania Ave., NW

Mail Code 7507P Washington DC 20460 Reviewed by: Stephen Carey , Biologist, ERB VI
William P. Eckel, Ph.D, Senior Science Advisor, ERB VI
Mark Corbin, Branch Chief, ERB VI



### Date: September 19 , 201 2

Table of Contents- Page 5 of 68

- 

### 1. Executive Summary

................................ ................................ ................................ .............. 7

1.1. Nature of Chemical Stressor

................................ ................................ ................................ .................... 7

1.2. Potential Risks to Non

- target Organisms

................................ ................................ ............................... 7

1.3. Conclusions

- Exposure Characterization

................................ ................................ .............................. 8

1.4. Conclusions

- Effects Characterization

................................ ................................ ................................ ... 8


### 2. Problem Formulation

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

2.1. Nature of Regulatory Action

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

2.2. Stressor Source and Distribution

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

2.2.1. Nature of Chemical Stressor

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

2.2.2. Overview of Pesticide Usage

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

2.3. Receptors

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

2.3.1. Aquatic and Terrestrial Effects

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

2.3.2. Ecosystems Potentially at Risk

................................ ................................ ................................ .......... 12

2.4. Assessment Endpoints

................................ ................................ ................................ ............................ 12 2.5. Conceptual Model

................................ ................................ ................................ ................................ ... 13

2.5. 1. Risk Hypotheses

................................ ................................ ................................ ................................ 13

2.5.2. Conceptual Diagram

................................ ................................ ................................ .......................... 13 2.6. Analysis Plan

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

2.6.1. Residues of Concern

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

2.6.2. Preliminary Identification of Data Gaps and Uncertainties

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

2.6.3. Evaluation of Multiple Active Ingredients and Mixtures

................................ ................................ .. 16

2.6.4. Measures of Exposure

................................ ................................ ................................ ....................... 16

2.6.5. Measures of Effect

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

2.6.6. Integration of Exposure and Effects

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

### 3. Analysis

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

3.1. Use Characterization

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

3.2. Exposure Characterization

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

3. 2.1. Environmental Fate and Transport Characterization

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

3.2.2. Measures of Aquatic Exposure

................................ ................................ ................................ .......... 24

3.2.3. Measures of Terrestrial Exposure

................................ ................................ ................................ ...... 28

3.3. Ecological Effects Characterization

................................ ................................ ................................ ...... 30

3.3.1. Aquatic Toxicity Assessment

................................ ................................ ................................ ............ 30

3.3.2 Terrestrial Effects Characterization

................................ ................................ ................................ ... 35


### 4. Risk Characterization

................................ ................................ ................................ ......... 39

4.1. Risk Estimation

................................ ................................ ................................ ................................ ....... 39

4.1.1. Aquatic Organisms

................................ ................................ ................................ ............................ 39

4.1.2. Terrestrial Organisms

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

4.2. Risk Description

................................ ................................ ................................ ................................ ...... 42

4.2.1 Exposure to Aquatic Organisms

................................ ................................ ................................ ........ 42

4.2.2 Risks to Aquatic Animals

................................ ................................ ................................ .................. 43

4.2.3 Risks to Aquatic Plants

................................ ................................ ................................ ...................... 43

4.2.4. Exposure to Terrestrial Organisms

................................ ................................ ................................ .... 44

4.2.5. Risks to Mammals

................................ ................................ ................................ ............................. 44

4.2.6. Risk to Birds

................................ ................................ ................................ ................................ ...... 44

4.2.7. Potential Effects on Terrestrial Invertebrates

................................ ................................ .................... 44

4.2.8. Risk to Terrestrial Non

- target Plants

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

4.3. Uncertainties and Data Gaps

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

4.3.1. Fate and Transport Uncertanties

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

4.3.2. Effects Uncertainties

................................ ................................ ................................ ......................... 46


### 5. Federally Threatened and Endangered (Listed) Species Concerns

............................... 46

5.1. Action Area

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

5.2. Taxonomic Groups Potentially at Risk

................................ ................................ ................................ . 47- Page 6 of 68

- 5.2.1. Probit Dose

- Response Analysis

................................ ................................ ................................ ...... 49

5.2.2. Listed Species Occurrence Associated with Ethaboxam Use

................................ ....................... 50


### 6. References

................................ ................................ ................................ ............................ 50

6.1. Submitted Environmental Fate and Transport Studies

................................ ................................ ..... 51

6.2. Submitted Ecotoxicity Studies

................................ ................................ ................................ .............. 51 

### Appendix A. Summary of Environmental Fate Data

................................ .............................. 52 Appendix B. Aquatic Model Input/Output Data.

................................ ................................ ... 53 Appendix C. Model Outputs

................................ ................................ ................................ ...... 56 Appendix D Ethaboxam and Degradate ECOSAR Estimates

................................ ................ 59- Page 7 of 68

- 

### 1. Executive Summary

1.1. Nature of Chemical Stressor

Valent is seeking registration for a product containing the new chemical fungicide ethaboxam ( V

- 10208 3.2 FS Fungicide ; N

- (cyano

- 2

- thienylmethyl)

- 4

- ethyl

- 2

- (ethylamino)

- 5

- thiazolecarboxamide ; CAS#: 162650

- 77

- 3 ; PC code: 090205 ). Ethaboxam disrupts microtubules and inhibits nuclear migrations from the cyst into the germ tube . It is proposed for use in

pro tecting emerging seedlings from pathogenic oomycetes including those in the Phytopthora

and Pythium groups.

This seed treatment assessment is for a national registration request for the following uses: legume vegetables (except coypeas and field peas), cereal grains (except rice and wild rice), and the rapeseed subgroup

. Maximum application rates of the active ingredient, ethaboxam, range from 0.0006 to 0.0 62 lbs a.i./A/yr. This assessment is based on proposed maximum application

rates for all uses.

On e end

- use formulation of ethaboxam applied as a flowable suspension to seed (34.2% a.i.) is proposed for registration in the United States. As a seed treatment, ethaboxam may be combined with multiple active and inert ingredients on the same seed. This ri sk assessment applied to the proposed end

- use forumation of ethaboxam and is not applicable if the formulation is used in conjunction with other active or inert ingredients.

Ethaboxam maintains much of its chemical structure in many of its degradation pr oducts. LGC

32533 and LGC

- 32525 are major degradates formed in abiotic and biotic degradation studies that are structurally the same as parent ethaboxam aside for the substitution of the cyanide group for an oxide or amide group, respectively. LGC

- 32799 is another major degradate but is only distinguished from parent ethaboxam by a double bond forming to the nitrogen on the bridge proximate to the thiophene group. Unidentified degradates exceeded 10% in soil photolysis, aqueous photolysis, and aerobic so il metabolism studies and could be structurally similar to parent ethaboxam. Major and minor degradates that significantly differ from ethaboxam have been identified as well. Only the thiazole and thiophene rings are maintained in the abiotic degradation products LGC

- 32523 and LGC

- 35525, respectively.

1.2. Potential Risks to Non

- target Organisms

The results of this screening

- level assessment on the proposed ethaboxam uses indicate that risk s of adverse effects to non

- target organisms are not expected for terrestrial and aquatic plants and

mammals.

Table 1.1. Potential Effects to Federally Listed Taxa Associated with Direct or Indirect Effects from the Proposed New Uses of Ethaboxam

.

Listed Taxon Direct Effects Indirect Effects a

Terrestrial and semi

- aquatic plants

- monocots No No

Terrestrial and semi

- aquatic plants

- dicots No No- Page 8 of 68

- Listed Taxon Direct Effects Indirect Effects a

Birds No No

Terrestrial

- phase amphibians and reptiles No No

Mammals No No Aquatic nonvascular plants No No

Aquatic vascular plants No No

Freshwater fish No No Aquatic

- phase amphibians No No

Freshwater crustaceans No No

Mollusks No No

Marine/estuarine fish No No

Marine/estuarine invertebrates No No

a direct effects are not expected for any taxa, therefore, indirect effects are not expected either.



### 1.3. Conclusions

- Exposure Characterization

Ethaboxam is moderately to slightly mobile in soil and is not expected to be volatile

. Laboratory

studies indicate ethaboxam degrades readily in soil ( aerobic soil metabolism half

- lives ranging

from 1 to 10 days ), but may persist longer if it reaches water ( stable to hydrolysis ; aquatic

metabolism half

- lives ranging from 1 to 2 months). However, the total toxic residues of ethaboxam (structurally

- similar degradates) may persist in soil with half

- lives of one to seve ral months. Because of the seed formulation, incorporation on planting, and low application rates, the potential of off

- site concentrations of toxic residues at levels that are toxic to nontarget organisms is expected to be low.

Ethaboxam maintains much of its chemical structure in many of its degradation products. LGC

32533 and LGC

- 32525 are major degradates formed in abiotic and biotic degradation studies that are structurally the same as parent ethaboxam aside for the substitution of the cyanide group f or an oxide or amide group, respectively. LGC

- 32799 is another major degradate but is only distinguished from parent ethaboxam by a double bond forming to the nitrogen on the bridge proximate to the thiophene group. Unidentified degradates exceeded 10% i n soil photolysis, aqueous photolysis, and aerobic soil metabolism studies and could be structurally similar to parent ethaboxam. Major and minor degradates that significantly differ from ethaboxam have been identified as well. Only the thiazole and thio phene rings are maintained in the abiotic degradation products LGC

- 32523 and LGC

- 35525, respectively. Data are unavailable for the transport and mobility of degradates. However, those that are structurally similar to parent ethaboxam are expected to have similar mobility.

Model input parameter calculations conservatively include all non

- CO 2 

### extractable residue to account for all potentially toxic residues. Unextracted residues are not included in model input parameter calculations because a pending study submission indicates unextracted residues persist despite harsh extraction techniques.

1.4

. Conclusions

- Effects Characterization

R isks to aquatic systems from acute and chronic exposure to this ethaboxam are expected to be

low. While ethaboxam is classified as “highly toxic” to aquatic invertebrates and “ moderately ”- Page 9 of 68

- 

### toxic to fish, across the freshwater and estuarine/marine systems, exposure for the seed treatment uses is expected to be sufficiently low so as to not trigger risk concerns . Aquatic pl ant data were only submitted for one species of freshwater algae. The 96

- hour EC50 and NOAEC values for

Psuedokirchinella subcapitata were >3.6 and 1.8 mg a.i./L. Data available in the Footprint

database 1 

### provide a 72

- hour EC50 value of 0.009 mg a.i./L for the freshwater algae Raphidocelis subcapitata and suggest that ethaboxam has widely variable toxicity to different species of non

vascular aquatic plants. This study should be submitted to the Agency for review. Data are not available for a vascular aquatic species.

Based on the available acute toxicity data, no mortality was observed in any of the mammalian

studies conducted on ethaboxam technical at the highest concentrations/doses tested; as such,

et haboxam is categorized as “practically nontoxic” to mammals on an acute exposure basis.

Ethaboxam is also categorized as “ practically non

- toxic ” to zebra

- finch, bobwhite quail , and

mallard duck on an acute aroal and subacute dietary basis. T reatment

- relat ed sublethal effects

were observed in mallard duck and bobwhite quail studies at the highest concentration s tested

. Sublethal effects included a decrease in food consumption and weight gain.

R esult s of a registrant submitted acute toxicity test with hone y bees suggest that ethaboxam is practically non

- toxic on both a contact and oral basis (LD 50 

### > 118 ug a.i./bee). However, additional data located in the Footprint database suggest that ethaboxam is toxic to honey bees, at least on a contact exposure basis (LD 50 

### = 51 ug a.i./bee ). In addition, results of an acute study with earthworms yielded a 14

- day LC 50 

### value greater than 1000 mg ai/kg dw soil (MRID 48535628; Supplemental) . While there are uncertainties in the actual exposure, results of this study indic ate that ethaboxam is practically non

- toxic to soil

- dwelling invertebrates

.

T errestrial plant data are not available for ethaboxam

. The registrant submitted data waiver requests for both the seedling emergence and vegetative vigor data requirements (MRID s 48535704 and 48535705, respectively), citing ethaboxam’s low field application rates as a seed treatment, relatively rapid soil half

- life ( 0.9 to 9.6 days depending on the soil), and fungicidal mechanism of action. While the Agency did not grant the wai ver request for the seedling emergence data because ethaboxam is chemically active during seed germination and may be

transmitted off

- site via run

- off, supporting data provided by the registrant on seed germination in the presence of ethaboxam (memo data 1 0/15/2012) suggest that the relatively low application rate of ethaboxam as a seed treatment does not inhibit seed germination. The Agency granted the waiver request for the vegetative vigor data because the seed treatment use is likely to result

in limit ed exposure to plant foliage. However, seedling emergence and vegetative vigor data would be necessary should the registrant submit a future registration request for an above

- ground spray application of ethaboxam.

2

. Problem Formulation

The purpose of p roblem formulation is to provide the foundation for the environmental fate and ecological risk assessment for the registration of the new chemical ethaboxam ( N

- (cyano

- 2

-

1 The Footprint database for ethaboxam may be accessed at http://sitem.herts.ac.uk/aeru/iupac/270.htm

.- Page 10 of 68

- 

### thienylmethyl)

- 4

- ethyl

- 2

- (ethylamino)

- 5

- thiazolecarboxamide ; CAS#: 162650

- 77

- 3 ; PC code:

090205 ). The problem formulation sets the objectives for the risk assessment, establishes a risk hypothesis and conceptual model depicting potential risk

, and provides a plan for analyzing the data and characterizing the risk associated with the proposed use of ethaboxam ( USEPA, 1998 ).

2.1

. Nature of Regulatory Action

T he U.S

. Environmental Protection Agency (EPA or the Agency) is required under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to ensure that the newly proposed use of

ethaboxam as a fungicide does not have the potential to cause unreasonable adverse effects to the

environment. In addition to non

- target animals and plants, potential effects to listed species ( i.e.

, species on the Federal list of endangered and threatened wildlife and plants) and their designated

critical habitat are also considered under the Endangered Species Act (ESA) in order to ensure

that the registration of ethaboxam is not likely to jeopardize the continued existence of listed species or adversely modify their critical habitat. In order to meet the requirements of FIFRA and the ESA, this assessment follows EPA guidance on conducting ecological risk assessments ( USEPA, 1998 ) and Office of Pesticide Program’s Overview Docu ment, which contains guidance for assessing pesticide risks to non

- target and listed organisms (USEPA, 2004)

.

The end result of the EPA pesticide registration process ( i.e. , the FIFRA regulatory action) is an approved ( or disapproved ) product label. The label is a legal document that stipulates how and where a given pesticide may be used. Product labels (also known as end

- use labels) describe the formulation type ( e.g. , liquid or granular), acceptable methods of application, approved use sites, and any r estrictions on how applications may be conducted. Therefore, the use, or potential use, described by the pesticide’s labels is considered “the action” being assessed. This assessment was prepared to support evaluation of the proposed new chemical registr ation of ethaboxam

.

2.2

. Stressor Source and Distribution

2.2. 1. Nature of Chemical Stressor

Valent is seeking registration for the use of the new chemical fungicide ethaboxam ( V

- 10208 FS Fungicide ), N

- (cyano

- 2

- thienylmethyl)

- 4

- ethyl

- 2

- (ethylamino)

- 5

- thiazolecarboxamide

. According to Valent

, ethaboxam works by distrupting microtubules and inhibiting nuclear migrations from the cyst into the germ tube. It is proposed for use in protecting emerging

seed lings from pathogenic oomycetes including those in the Phytopthora and Pythium groups.

Ethaboxam is formulated as a flowable suspension that will be used to coat certain crop seeds (V

- 10208 FS Fungicide ®)

. It is applied to legume vegetables (except cow peas and field peas), cereal grains (except rice and wild rice), and crops in the rapeseed subgroup.

The proposed maximum annual application rates on legume vegetables are the highest of the new

uses

. Legumes may be treated with a single maximum applic ation rate of 0.0 62 lbs a.i./A. Other

crop treatments are proposed at l ow er seasonal rates a s discussed in Section 3.1.- Page 11 of 68

- 

### Parent ethaboxam and all non

- CO 2 

### degradates are conservatively considered the chemical stressor in a total toxic residue approach. Unextracted residues are not included in total toxic

residues.

2.2.2

. Overview of Pesticide Usage

Usage data are not available for ethaboxam because it is a new active ingredient proposed for use

in the United States

.

Ethaboxam may be applied to seed using mechanical, slurry, or mist

- type seed treatment equipment, provided that the equipment is calibrated for accurate and uniform application

. T he following labeling statements appear on the proposed label to avoid contamination of aquatic

enviornments :

ENVIRONMENTAL HAZARD STATEMENTS

• This pesticide is extremely toxic to fish, aquatic invertebrates, oysters and shrimp. Do not discharge effluen t containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been

notified in writin g prior to discharge. Do not discharge effluent containing this product into sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA.

In addition , t he proposed label requires the following statements on appear on the container of

seed treated with V

- 10208 3.2 FS Fungicide: “Treated seeds exposed on the soil surface may be hazardous to wildlife. Cover or collect treated seeds spilled during loading.

2.3

. Receptors

2.3.1

. Aquatic and Terrestrial Effects

In ecological risk assessment, a receptor is a biological entity that is exposed to a stressor ( USEPA, 1998 ). Consistent with the process described in the Overview Document (USEP A

, 2004 ), this r isk assessment uses a surrogate species approach in its evaluation of ethaboxam

. Toxic ity data generated using surrogate test species, which are intended to be representative of broad taxonomic groups, are used to infer potential ef fects on a variety of s pecies (r eceptors)

included under these broader taxonomic groupings. Table 2.1 provides the general taxonomic groups and surrogate species tested to evaluat e potential ecological effects of ethaboxam to
broad classes of non

- target organisms

. Within each of these taxonomic groups, a measure of

effect is selected from among the available test data.- Page 12 of 68

- 

### Table 2.1. Taxonomic Groups and Test Species Evaluated for Assessing Potential Ecological Effects of Ethaboxam

. Taxonomic Group Typical Species

Birds 1 Mallard duck ( Anas platyrhynchos ) Bobwhite quail ( Colinus virginianus )

Mammals Norway rat ( Ratus norvegicus )

Terrestrial In vertebrates Honey bee ( Apis mellifera L. )

Freshwater fish 2 Bluegill sunfish ( Lepomis macrochirus ) Rainbow trout ( Oncorhynchus mykiss ) Fathead minnow ( Pimephales promelas )

Freshwater invertebrates Water flea ( Daphnia magna ) Midge ( Chironomus riparius )

Estuarine/marine fish Sheepshead minnow ( Cyprinodon variegatus )

Estuarine/marine invertebrates Mysid ( Americamysis bahia ) Eastern oyster ( Crassostrea virginica ) Terrestrial plants 3 Monocots

– Crop species, such as corn ( Zea mays )

Dicots

– Crop Species, such as soybean ( Glycine max ) Aquatic plants and algae 4 Duckweed ( Lemna gibba ) Freshwater Algae ( e.g., Pseudokirchneriella subcapita ta )

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 Freshwater fish may be surrogates for aquatic

- phase amphibians.

3 Four species of two families of monocots, of which one is corn; six species of at least four dicot families, of which one is soybeans.

4 Four species of non

- vascular algae including a freshwater green algae, a cyanobacterium, a marine diatom, and a freshw ater diatom.



### 2.3. 2. Ecosystems Potentially at Risk

The ecosystems potentially at risk are often extensive in scope; therefore, it may not be possible to identify specific ecosystems during the development of a nation

- wide ecological risk assessment. However, in general terms, terrestrial ecosystems potentially at risk could include the treated field and immediately adjacent areas t hat may receive runoff. As a seed treatment, exposure to drift is not likely. Areas adjacent to the treated field could include cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats,

and other uncul tivated areas. Aquatic ecosystems potentially at risk include water bodies adjacent to or downstream from use site s, and might include impounded bodies such as ponds, lakes and reservoirs, or flowing waterways such as streams or rivers including all adjacent off

channel habitats that are permanently or intermittently connected to flowing waters. For uses in

coastal area s, aquatic habitat also includes marine ecosystems, including estuaries, embayments,

and near

- shore environments such as tidal marshes

.

2.4

. Assessment Endpoints

Assessment endpoints represent the actual environmental value that is to be protected, defined by an ecological entity (species, community, or other entity) and its attribute or characteristics ( USEPA, 1998 ). For ethaboxam , ecological entities o f potential concern include the following:

birds , amphibians, reptiles, mammals, freshwater fish and invertebrates, estuarine/marine fish and invertebrates, terrestrial plants, terrestrial invertebrates , and aquatic vascular and non

vascular plants. The attributes for each of these entities may include growth, survival, and reproduction ( Table 2. 2 in Section 2.6. 4 ).- Page 13 of 68

- 

### 2.5 . Conceptual Model

For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor. For an ecol ogical pathway to be complete, it must have a source, a release mechanism, an environmental transport me chanism , and a feasible route of exposure.

The conceptual model is intended to provide a written description and visual representation of anticipated r elationships between ethaboxam

, potential routes of exposure, and the predicted effects for the assessment endpoint s

. The conceptual model consists of two major components: risk hypotheses and a conceptual diagram ( USEPA, 1998 ).

2.5. 1. Risk Hypotheses

For ethaboxam , the fol lowing generic ecological risk hypothes i s i s being employed for this screening

- level risk assessment:

Ethaboxam , when used outdoors in accordance with registered labels, have the potential

to lead to off

- site movement of the compound via run

- off and eroded soil leading to exposure of nontarget plants and animals

.

Based on information on the environmental fate, m ode of action, direct toxicity and potential indirect effects, EFED assumes that the proposed uses of ethaboxam ha ve the potential to cause reduced survival, growth, and reproduction to non

- target terrestrial and/ or aquatic animals and plants.

2.5.2

. C onceptual Diagram

The conceptual model is a graphic al representation of predicted relationships between ecological

receptor s , both listed (threatened and endangered) and non

- listed, and the stress ors to which they may be exposed. A conceptual model specifies potential routes of exposure, biological receptor types, and effects endpoints of potential concern.

Ethaboxam and its degradates are expected to persist in both terrestrial and aquatic envi ronments under aerobic and anaerobic conditions, and are considered moderately to slightly mobile, lipophilic, and nonvolatile. There is no evidence of degradation via hydrolysis. Ethaboxam has not been shown to bioconcentrate in aquatic organisms.

Eth aboxam is applied to seeds as a seed treatment. Many seeds are incorporated, but given the persistence and mobility of ethaboxam, the chemical and/or its major degradates may be transported off

- site in runoff. Ecologically significant spray drift is not expected for seed

treatments. Figure 2.1 depicts the stressors, exposure pathways, and potential effects to- Page 14 of 68

- 

### terrestrial organisms from proposed uses of ethaboxam. Figure 2.2 depicts the stressors, exposure pathways, and potential effects to aquatic organisms from proposed uses of ethaboxam. For both figures, dotted lines indicate exposure pathways that are expected to have a low likelihood of contributing to ecological risk.

Figure 2.1. Conceptual model for ethaboxam seed treatment effects on terrestrial organisms. 

### Stressor

Source

Receptors

Attribute Change Ethaboxam treated seeds applied to use site and degradates

Direct application

Birds / Terrestrial

phase amphibians / reptiles /

mammals Seeds

Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain

Reduction in prey Habitat integrity Reduction in primary productivity

Reduced cover Community change Terrestrial/riparian plants grasses/forbs, fruit, terrestrial

invertebrates Runoff

Mammals 

### Exposure

Media Soil

Ingestion Ingestion

Ingestion Ingestion Dermal uptake/Ingestion

Root uptake

Wet/dry deposition

Birds / Amphibians

Ingestion- Page 15 of 68

- Figure 2.2. Conceptual model for ethaboxam seed treatment effects on aquatic organisms.



### 2.6 . Analysis Plan

2.6.1

. Residues of Concern

Major transformation products resulting from the environmental degradation of e thabox am are LGC

- 32524, LGC

- 32525, LGC

- 32533, LGC

- 32799, LGC

- 35525, 2

- thiophene carboxylic acid, and two unidentified compounds. Ethaboxam represents a novel mode of action and, as a result, the toxic moiety is not well understood. However, ECOSAR modeling results indicate that

LGC

- 32799 is potentially significantly more toxic than parent ethaboxam. Other degradates are

estimated to be less toxic. Additonally, no data is available on degradate toxicity. All major degradates retain the thiazole group, the thienyl group or both. Given the unknown relative toxicity and structural similarity to parent ethaboxam, al l major degradates are assumed equally toxic as parent ethaboxam for the purposes of environmental modeling, however, the potential enhanced toxicity of LGC

- 32799 will be characterized

.

2.6.2. Preliminary Identification of Data Gaps and Uncertainties 

### Stressor

Source

Receptors

Attribute Change Ethaboxam treated seeds applied to use site and degradates

Fish/aquatic

- phase amphibians Eggs

Larvae

Juveniles / Adults

Individual organisms

Reduced survival Reduced growth Reduced reproduction Food chain Reduction in algae Reduction in prey Habitat integrity Reduction in primary productivity

Reduced cover Community change Surface water/

Sediment Runoff

Aquatic Animals

Invertebrates

Vertebrates 

### Exposure

Media

Uptake/gills or integument

Ingestion Ingestion Wet/dry deposition Soil Groundwater

Uptake/gills or integument

Aquatic Plants

Non

- vascular

Vascular Uptake/cell, roots, leaves Riparian plant

terrestrial

exposure pathways see

Figure 2.1- Page 16 of 68

- 

### A terrestrial field dissipation study has not been submitted for this new chemical and environmental fate data specific to the seed treatment use have not been submitted. Ethaboxam major degradates are structurally similar to parent ethaboxam and environmental fate dat a specific to these residues have not been submitted. Unextracted residues in environmental fate studies are as high as 70% by study termination. More complete extraction techniques can be employed as some unextracted residue may be bioavailable.

There are several notable data gaps and uncertainties in the characterization of ecological effects for ethaboxam, including an incomplete dataset for aquatic vascular and non

- vascular plants, and a complete lack of terrestrial plant data. While potential exposu re to ethaboxam from the proposed seed treatment uses is expected to be low enough to mitigate some of the concerns associated with these data gaps, these data would be necessary to assess risks from any future registration requests for an above

- ground spr ay applications of ethaboxam. In the absence of this data risks to aquatic and vascular plants will be presumed.

2.6. 3

. Evaluation of Multiple Active Ingredients and Mixtures

The Agency does not routinely include in its risk assessments an evaluation o f mixtures of active ingredients, either those mixtures of multiple active ingredients in product formulations or those in the applicator’s tank. In the case of the product formulations of active ingredients (that is, a registered product containing more than one active ingredient), each active ingredient is subject to an individual risk assessment for regulatory decision regarding the active ingredient on a particular use site. If effects data are available for a formulated product containing more than

o ne active ingredient, they may be used qualitatively or quantitatively in accordance with the Agency’s Overview Document and the Services’ Evaluation Memorandum (U.S. EPA 2004; U.S. FWS/NMFS 2004). However, the proposed end

- use product for the new chemical

ethaboxam is a s a single active ingredient formulation.

2.6. 4

. Measures of Exposure

Measures of exposure are based on aquatic and terrestrial models tha t estimate environmental

concentrations of ethaboxam using labeled application rates and methods. For aquatic exposure

t he Tier II model Pesticide Root Zone Mo del (PRZM v3.12.2; May 12, 2005 ) linked with EXposure Analysis Modeling System (EXAMS v2.98.4.6; Apr. 25, 2005) via the PRZM/EXAMS model shell (PE v5.0, Nov. 15, 2006), i.e. , PRZM/EXAMS) was used to

estimate screening

- level exposure concentrations in aquatic environments

. The measure of exposure for aquatic species in surface water bodies receiving runoff and/or spray drift is a return frequency of 1

- in

- 10 years of the estimated environmental concentration s (EEC), based on 30

- year simulations. The maximum 1

- in

- 10 year return frequency concentration is used for estimating acute exposure s to aquatic organisms (plants and animals) ; the 1

- in

- 10 year 21

- day mean concentration is used for assessing aquatic invertebrate chronic exposure; and the 1

- in

- 10 year 60

- day mean concentration is used for assessing chronic exposure for fish (and aquatic

phase amphib ians for which fish serve as surrogates ). E xposure to benthic organisms from

sediment concentrations in water bodies was assessed ; pore

- water 1

- in

- 10 year EECs were

calculated for maximum use patterns

.- Page 17 of 68

- 

### Terrestrial exposure estimates for avian and mamma lian risk assessments were derived using the

T

- REX model ( version 1. 5

. 2

, 06/11/13 ). The assumption of the model is that mammals and

birds may be exposed via their consumption of treated seeds on or immediately adjacent to the site of application.

The S creening I mbibition P rogram (SIP v.1.0) and Screening Tool for Inhalation Risk (STIR v.1.0) were used to calculate upper bound estimate s of wildlife exposure via drinking water and inhalation, respectively, using ethaboxam solu bility or vapor pressure, av ian and mammalian toxicity endpoints

.

2.6. 5

. Measures of Effect

Measures of effect are obtained from a suite of registrant

- submitted guideline studies that were conducted with a limited number of surrogate test species ( Table 2.1)

. No additional ecotoxicity

data on ethaboxam were located, based on an August 2011 query of the open literature in the public ally available version of the ECOTOX database ( http://cfpub.epa.gov/ecotox/ ).

The acute measures of effect used in this baseline assessment are the LD 50 

### ( median Lethal Dose),

LC 50 

### ( median Lethal Concentration) or EC 50 

### ( median Effects Concentration). These are measures of acute toxicity which result in 50% of the respective effect in tested organisms. The endpoints for chronic mea s ures of exposure are the no observed adverse effect concentration ( NOAEC ) and the no observed adverse effect level ( NOAEL ) . Toxicity studies were submitted for freshwater fish and invertebrates, estuarine/marine fish and invertebrates, aquatic plants,

bir ds, mammals

, bees , and other terrestrial invertebrates . The endpoints used for risk

characterization are derived from studies which underwent review and were classified as “acceptable” (conducted under guideline conditions and considered to be scientifica lly valid) or “supplemental” (conditions deviated from guidelines but the results are considered to be scientifically valid).

Table 2. 2 lists the measures of environmental exposure and ecological effects used to assess the potential risks of ethaboxam to non

- target organisms. The methods used to assess the risk are consistent with those outlined in the document “Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs” (USEPA, 2004).- Page 18 of 68

- 

### Table 2.2. Measures of Exposure and Measures of Effect Used in Assessing Potential Risks Associated with the Proposed Use s of Ethaboxam

.
Assessment Endpoint Surrogate Species and Measures of Ecological Effect 1 Measures of Exposure

Birds 2 Survival Lowest acute LD 50 (single oral dose test) and LC 50 (subacute dietary test) Upper

- bound residues on

food items ( i.e., seed)

Reproduction

and Growth Lowest NOAEC (21

- week reproduction test)

Mammals Survival Lowest acute LD 50 (single oral dose test)

Reproduction

and Growth Lowest NOAEC (2

- generation reproduction test)

Aquatic Animals ( F ish and

invertebrate s) 3 Survival Lowest tested LC 50 or EC 50 (acute toxicity test) Peak EEC s 4

Reproduction

and Growth Lowest NOAEC ( early life

- stage or full

life

- cycle test s ) 21

- day EECs for invertebrates

and 60

- day EECs for fish 4

Terrestrial plants 5 Survival and growth Lowest EC 25 (for non

- listed plants) and

corres ponding NOAEC (for listed plants)

(endpoints derived for monocots and dicots from seedling emergence and vegetative vigor studies) Estimates of runoff and spray

drift to non

- target areas

Insects 6 Survival Lowest h oneybee LD 50 (acute contact test)

Lowest Earthworm LC 50 Maximum application rate for honeybees and estimates of

soil concentrations for

earthworms

Aquatic plants (vascular

and non

- vascular) Survival and growth Lowest EC 50 (for non

- listed plants) and corresponding NOAEC or EC 05 (for listed plants) Peak EEC s 4

1 The most sensitive species tested within taxonomic groups is used for screening

- level risk assessments.

2 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

3 Freshwater fish represent surrogates for aquatic

- phase amphibians

. 4 Aquatic EECs are based on modeling described in Section 3.2.2.1

. 5 Four species of two families of monocots

- one is corn, six species of at least four dicot families, of which one is soybeans.

6 Risk to terrestrial invertebrates from ethaboxam use is not evaluated, rather the potential hazard to honey bees and earthworms (i.e. the availabl e data) are qualitatively assessed.



### 2.6. 6

. Integration of Exposure and Effects

E xposure and toxicity data are integrated in order to evaluate the risks of adverse ecological

effects on non

- target species. For the screening

- level risk assessment of ethaboxam , the

deterministic risk quotient (RQ) method is used to compare estimated exposure concentrations

with measured toxicity values. The RQ method involves dividing point estimates of

environmental concentrations by acute and chronic toxicity values

. The resulting unitless RQs are then compared to the Agency’s L evels of C oncern (LOC ) (USEPA

, 2004) ( Table 2.3 ). These criteria are used to indicate when applications of ethaboxam , as directed on the proposed

label s , have the potential to cause adverse e ffects to listed and non

- listed non

- target organisms.- Page 19 of 68

- 

### Table 2.3. Agency Risk Quotient (RQ) Metrics and Levels of Concern (LOC) Per Risk

Class.

RISK CLASS RISK DESCRIPTION RQ LOC

Aquatic Animals (fish and invertebrates)

Acute Potential for effects to non

- listed animals from acute

exposures Peak EEC/LC 50 1 0.5

Acute

Restricted Use Potential for effects to animals from acute exposures Risks may be mitigated through restricted use classification Peak EEC/LC 50 1 0.1

Acute Listed Species Listed species may be potentially affected by acute

exposures Peak EEC/LC 50 1 0.05

Chronic Potential for effects to non

- listed and listed animals from chronic exposures 60

- day EEC/NOAEC (fish) 1 21

- day EEC/NOAEC (invertebrates)

Aquatic Plants

Non

- Listed Potential for effects to non

- listed plants from exposures Peak EEC/LC 50 1 1

Listed Potential for effects to listed plants from exposures Peak EEC/NOAEC 1

Terrestrial Animals (mammals and birds)

Acute Potential for effects to non

- listed animals from acute

exposures EEC 2 /LC 50 (Dietary) 0.5 EEC/LD 50 (Dose)

Acute

Restricted Use Potential for effects to animals from acute exposures Risks may be mitigated through restricted use classification EEC 2 /LC 50 (Dietary) 0.2 EEC/LD 50 (Dose)

Acute Listed Species Listed species may be potentially affected by acute

exposures EEC 2 /LC 50 (Dietary) 0.1 EEC/LD 50 (Dose)

Chronic Potential for effects to non

- listed and listed animals from chronic exposures EEC 2 /NOAEC 1

Terrestrial Invertebrates

Acute Porential effects to non

- listed and listed terrestrial

invertebrates EEC 3 /LD 50 (contact) 0. 05

Terrestrial and Semi

- Aquatic Plants

Non

- Listed Potential for effects to non

- target, non

- listed plants from

exposures EEC/ EC 25 1

Listed Plant Potential for effects to non

- target, listed plants from

exposures EEC/ NOAEC 1 EEC/ EC 05 4

1 LC 50 or EC 50

. 2 Based on upper bound seeding rates

. 3 Based on arthropod residues.

4 Only used when NOAEC value is not available.



### 3 . Analysis

3.1

. Use Characterization

Ethaboxam is proposed for use as a flowable suspension used to coat certain crop seeds

. Proposed m aximum application rates and use patterns listed by use according to the proposed- Page 20 of 68

- 

### labels are provided in Table 3.1

. The presented estimated maximum use rates were cal culated from the labeled rate, in volume per seed weight, and seeding rates per acre. The registrant provided use rates in a November 28, 2012 presentation . The calculated use rates are higher than

those provided by the registrant, therefore, the calcula ted use rates will be used for the derivation

of estimated environmental concentrations. The discrepancy between the registrant’s estimated maximum rate and the calculated maximum rate is likely due to the maximum weight of seed applied per acre, 411 lbs/ ac for garden pea in this instance.

Table 3.1

. Proposed Maximum Use Patterns of Ethaboxam

.

Crop/Use Seed Application

Rate (fl oz per cwt seed) Seed (lbs/ac) Maximum Application

Rate (lbs a.i./A) Maximum

Number of Applications Application

Interval (days) Maximum Yearly Application (lbs a.i./A/yr) Meth Appli

Crop Group 6 (Legume vegetables except cowpea and field pea): Lupinus ( grain lupin, sweet lupin, white lupin, and white sweet lu

Phaseolus (field bean, kidney bean, lima bean, navy bean, pinto bean, runner bean, snap bea, tepary bean, and wax bean); Vigna (adzuk asparagus bean, blackeyed pea, catjang, Chinese longbean, crowder pea, moth bean, mung bean, rice bean, southern pea, urd bea n, and yardlong bean); fava bean; chickpea; guar; jackbean; lablab bean; lentil; Pisum (dwarf pea, edible

- podded pea, English pea, garden pea pea, snowpea, and sugar snap pea); pigeon pea; soybean; sword bean. Crop Group 15 (Cereal grains except ric e and wild rice): Barley; buckwheat; millet; pearl; proso; oats; rye; teosinte; triticale; wheat (sweet and field); popcorn, sorghum; grain. Crop Group 20A (Rapeseed subgroup of oilseed group): Rapeseed, canola varieties only; borage; crambe; cuphea; echium; flax seed of pleasure; hare’s ear mustard’ lesquerella; lunaria; meadowfoam; milkweed; mustard seed; oil radish; poppy seed; rapeseed; sesame; rocket

Crop Group 6 0.6 411 (garden pea) 0.062 NS NS NS Seed tr

Crop Group 15 0.3 156 (wheat) 0.0117 N S N S N S Seed tr Croup Group 20A 0.3 8.2 (rape) 0.000615 N S N S N S Seed tr



### 3.2. Exposure Characterization

3.2.1. Environmental Fate and Transport Characterization

The general physical/chemical properties of ethaboxam are summarized in Table 3.2 . The Agency’s understanding of these properties is limited by the available dataset. Data submitted using ethaboxam as the test material is summarized in Appendix A

.

Table 3.2 General Physical and Chemical Properties of Etha boxam

Parameter Value Reference

PC code 090205

--

CAS No. 162650

- 77

- 3

--

Structure

--- Page 21 of 68

- Parameter Value Reference

Chemical name (IUPAC) ( RS )

- N

- (α

- cyano

- 2

- thenyl)

- 4

- ethyl

- 2

- (ethylamino)

- 1,3

- thiazole

- 5

- carboxamide --

Chemical name (CAS) N

- (cyano

- 2

- thienylmethyl)

- 4

- ethyl

- 2

- (ethylamino)

- 5

thiazolecarboxamide --

Common name Ethaboxam (LGC

- 30473)

--

Chemical formula C 14 H 1 6 N 4 O S 2 -- Molecular weight 320.43 g/mol USEPA 2006b

Water solubility (20oC, pH 7) 5.2 mg/L MRID 46378504

Vapor pressure (25oC) 6.1 x10
- 7 mm Hg MRID 46378504

Henry's law constant 4.95 x10
- 8 atm

- m 3 /mol MRID 46378504

Octanol

- water partitioning coefficient Log K OW (20oC, pH 7) 2.89 MRID 46378504

Dissociation constant (pKa) 3.6 MRID 46378504

Melting point ( oC ) 185 MRID 46378504



### Ethaboxam is moderately to slightly mobile in soil (K

oc 

### = 404

- 1,684 mL/g o.c.)

. The reported log octanol/water partition coefficient value ( 2.89 ) and fish bioaccumulation factor (4.5

- 5.1 )

suggest that ethaboxam does not readily bioaccumulate. With a vapor pressure of 6.1x10 - 7 

### mm Hg and a limited solubility, the calculated Henry’s Law Constant for ethaboxam is relativiely low ( 3.8x10 - 8 

### atm

- m 3 

### /mol). Table 3.2 lists various important physicochemical characteristics of

the chemicals. A summary of the submitted environmental fate and transport data is provided in

Table 3.3

.

Laboratory studies have indicated that ethaboxam degrade s through a combination of biotic and

abiotic reactions. Under acidic

, neutral , and basic conditions

, this compound is stable to hydrolysis . Ethaboxam is susceptible to aqueous photo lysis with a half

- li f e of 4.5 days.

Ethaboxam is shown to biodegrade in aerobic soils with half

- lives ranging from 0.9

- 9.6 days. However, unextracted residues in all aerobic soil metbalism studies ranged from 55% to 70%. These residues could be bioavailable parent compound considering only one extraction technique was used across all current aerobic soil metabolism studies. Ethaboxam is more persistent to aerobic aquatic me tabolism (t1/2 = 29 to 52 days) and anaerobic soil metabolism (t1/2 = 135 days ). Ethaboxam is considered moderately to slightly mobile in soils based on the FAO soil mobility classification (K

oc 

### from 404 to 1,684 mL/ g ). Ethaboxam is not expected to

bioconcentrate in fish ( BCF = 4.5

- 5.1 X in whole fish) and it rapid ly depurates from fish tissue

.

Table 3.3 Environmental Fate Data Summary for Ethaboxam

Property Value : Parent Only

--- Total Toxic Residues Reference

Hydrolysis half

- life: pH 5 pH 7 pH 9 stable

stable

stable MRID 48535660- Page 22 of 68

- Property Value : Parent Only

--- Total Toxic Residues Reference

Aqueous photolysis half

- life 4.5 days

--- Stable MRID 48535661

Soil photolysis half

- life Stable

--- Stable MRID 48535662

Aerobic soil metabolism

half

- life Sandy loam: 0.9 day (unextracted up to 69%)

--- 36 days (DFOP) Clay loam: 9.6 days (unextracted up to 60%)

--- 114 days (IORE) Loam: 1.9 days (unextracted up to 70%)

--- 59 days (DFOP)

4.4 days ( unextracted up to 54.8% )

--- 126 days (DFOP) MRID 48535663

MRID 48535664

Anaerobic soil metabolism

half

- life 135 days (DFOP, sandy loam)

Some CO2 formation, unextracted up to 25% MRID 48535668

Aerobic aquatic metabolism

half

- life 52 days

--- 267 days (SFO) 29 days

--- 165 days (SFO) MRID 48535666

Anaerobic aquatic

metabolism half

- life 151 days

--- 1,287 days (SFO) MRID 48535667

Adsorption coefficient

K

oc (mL/g o.c.)

---------------------------------- Aged Column Leaching Study 557 (Sandy loam)

411 (Loamy sand) 404 (Sand) 1,684 (Loam) 426 (Sandy clay) (moderately to slightly mobile)

------------------------------------------------------------------------- Leachate is 1.5

- 2.7% of applied radioactivity MRID 48535669

---------------------- MRID 48719401

Terrestrial Field Dissipation Study N/A N/A

Bioconcentration factor (BCF) 4.5

- 5.1 Depuration t 1/2 = 1.6

- 2.4 days MRID 48535624



### 3.2.1.1. Transport and Mobility

Ethaboxam is considered moderately to slightly mobile in soil. Soil organic carbon adsorption coefficients (K

oc 

### ) for ethaboxam ranged from approximately 404 to 1

, 684 mL/ g in five soils ( sandy loam, loamy sand, sand, loam, and sandy clay ). The weak mobility along with the relatively low vapor pressure ( 6.1x 10 - 7 

### mm Hg ) and Henry’s law constant ( 3.8x10 - 8 

### atm

- m 3 

### /mol ), indicates that volatilization from water and soil will not be an important transport process.

Data are unavailable for the transport and mobility of degradates. However, those that are- Page 23 of 68

- 

### structurally similar to parent ethaboxam are expected to have similar mobility.

3.2.1.2. Degradation

Ethaboxam is stable to hydrolysis at pH 5, 7, and 9. Ethaboxam degrades readily to aqueous photolysis with a half

- life of 4.5 days but is stable to soil photolysis. Ethaboxam also degrades readily in aerobic conditions with soil metabolism half

- lives ranging from 0.9 to 9.6 days in sandy loam, clay loam, an d loam soils and aquatic metabolism half

- lives ranging from 29 to 52 days. Degradation occurs less readily in anaerobic conditions as soil metabolism half

- life estimate is 135 days and the aquatic metabolism half

- life estimate is 151 days.

Ethaboxam ma intains much of its chemical structure in many of its degradation products. LGC

32533 and LGC

- 32525 are major degradates formed in abiotic and biotic degradation studies that are structurally the same as parent ethaboxam aside for the substitution of the cyanide group for an oxide or amide group, respectively. LGC

- 32799 is another major degradate but is only distinguished from parent ethaboxam by a double bond forming to the nitrogen on the bridge proximate to the thiophene group. Unidentified degradates exceeded 10% in soil photolysis, aqueous photolysis, and aerobic soil metabolism studies and could be structurally similar to parent ethaboxam. Major and minor degradates that significantly differ from ethaboxam have been identified as well. Only the th iazole and thiophene rings are maintained in the abiotic degradation products LGC

- 32523 and LGC

- 35525, respectively. Figure 3.4 identifies the major degradation products.

Figure 3.4. Identified Major Degradates

Common Name Structure

LGC

- 32533

LGC

- 32525- Page 24 of 68

- LGC

- 32799



### LGC

- 3252 3

LGC

- 35525

3.2.1.3. Field Studies

No field studies have yet been submitted for ethaboxam.

3.2.1.4. Bioconcentration

The reported value of log octanol/ water partition coefficient of 2.89 suggests that ethaboxam will likely not bioaccumulate in aquatic organisms. This is corroborated with BCFs for whole

fish ranging from 4.5

- 5.1X and a depuriation half

- life of 1.6

- 2.4 days.

3.2.2. Measures of Aquatic Exposure- Page 25 of 68

- 

### 3.2.2.1. Surface Water Exposure

The Tier II model Pesticide Root Zone Model (PRZM v3.12.2; May 12, 2005; Carousel et al.

, undated) linked with EXposure Analysis Modeling System (EXAMS v2.98.4.6; Apr. 25, 2005; Burns, 2004) via the PRZM/EXAMS model shell (PE v5.0, Nov. 15, 2006)

, i.e.

, PRZM/EXAMS) and the Tier I Rice Model (v1.0, May 8, 2007) were used to estimate screening

level exposure concentrations in aquatic environments. The PRZM model simulates pesticide movement and transformation on and across the agricultural field re sulting from crop applications. The EXAMS model simulates pesticide concentrations in water due to loading via runoff, erosion, and spray drift, assuming a standard 1

- ha pond, 2

- m deep (20,000 m 3 

### ) with no

outlet that borders a 10

- ha treated field. Simula tions are for multiple (usually 30) years, from which the Agency estimates peak values that are expected to recur on average once every ten years, based on time series of daily estimated concentrations. The coupled PRZM and EXAMS

models and user’s manuals are available from the U.S. Environmental Protection Agency Water

Models web

- page (USEPA, 2011b).

Exposure estimates generated using the standard pond are intended as surrogates for potential concentrations in a wide variety of vulnerable water bodies, including prairie potholes, playa lakes, vernal pools, other wetlands, man

- made and natural ponds, and ephemeral and first

- order

streams. Innumerable site

- specific factors will tend to make such water bodies more or less vulnerable than the standard pond. Static water bodies that have larger ratios of pesticide

- treated drainage area to water body volume are generally expected to have higher peak concentrations than the standard pond’s EECs. Such water bodies may be smaller in size, and/or have larger

dra inage areas. However such water bodies may be more likely to overflow and discharge pesticide in their effluent, whereas the standard pond has no discharge. As watershed size increases, it becomes increasingly unlikely that the entire watershed is plante d with a single crop that is all treated simultaneously with a pesticide. Headwater streams may have peak concentrations that are higher than those predicted for the standard pond, but such concentrations will likely persist for only short periods of time or distance, as they are carried downstream and diluted with water originating elsewhere.

The general chemical and environmental fate data for ethaboxam listed in Table 3.2

- 3.3 were used for generating model input parameters for PRZM and EXAMS (listed in Table 3.5 ).

C hemical specific and model input values were chosen in accordance with current divisional guidance (USEPA, 2009). Where data was submitted specific to ethaboxam , these data are

identified below in Table 3.5.

Input parameter degradation half

- lives are calculated including total toxic residues (TTR). These

residues include all non

- CO 2 

### extractable residues detected in the suite of degradation studies. This TTR approach i ncludes three major degradates that are structurally similar to parent ethaboxam but also includes a major degradate and several minor degradates that are less similar ( i.e. , one

- ring compounds). Unidentified extractable residues are also included in the

calculation . The inclusion of all extractable residue is conservative but the toxic moiety associated with ethaboxam is unknown and therefore any degradate is potentially toxic.- Page 26 of 68

- 

### Though unextracted residues are very high in metabolism studies and could po tentially be bioavailable, these residues are not included in the TTR approach. Unextracted residues in submitted aerobic soil metabolism studies were 55% to 70% of applied radioactivity by study conclusion when only an acetone extraction was performed. The product registrant has performed, but not yet submitted for review, an additional aerobic soil metabolism study using acidic and neutral organic solvent extractions that resulted in 31% to 44% applied radioactivity

as unextracted residue. Though unext racted residue may have decreased significantly, the acidic extraction conditions may be more harsh than what might be found in the environment. This indicates that unextracted residues may be bound in the soil matrix. Due to this evidence and the

conser vatism associated with including all non

- CO 2 

### extractable residue in the TTR approach,

unextracted residues are not included in the TTR approach.

Table 3.5. PRZM and EXAMS Surface Water Chemical Input Parameters for Ethaboxam.

Parameter (units) Value(s) Sources Comments

Chemical Name Ethaboxam Label Proposed label

K OC (mL/g o.c.) 696 MRID: 48535669 Represents the average K OC value

among five values ranging from 404 to

1

, 684 ml/g o.c. ; the K OC model was

utilized as adsorption correlates with organic carbon content

Aerobic Soil Metabolism (days) 119 MRID 48535663

MRID 48535664 Represents the 90 th percentile of the upper confidence bound on the mean of

four TTR half

- life values : 36, 114, 59,

and 126

Application Efficiency (fraction) 1.0 Seed Treatment

Incorporation depth (cm) 5 “A 2

- inch planting depth is ideal for average conditions” 

### http://www.extension.iastate.edu /publications/pm1885.pdf
Spray Drift (fraction) 0.0 Se ed Treatment Solubility in Water (ppm) 5.2 MRID 46378504 At 20°C Aerobic Aquatic Metabolism (days) 373 MRID 48535666 Represents the 90 th percentile of the upper confidence bound on the mean of

two TTR half

- life values: 267 and 165 days Anaerobic Aquatic Metabolism (days) 3,861 MRID 48535667 3X the single TTR half

- life value

Hydrolysis at pH 7(days) stable MRID 48535660 Aqueous Photolysis @ pH 7 (days) stable MRID 48535661

Molecular Weight (g/mole) 320.43 MRID 46378504 Vapor Pressure (torr or mmHg) 6.1x10
- 7 MRID 46378504

Henry’s Law Constant (atm

- m 3 /mol) 4.95 x10
- 8 MRID 46378504- Page 27 of 68

- 

### The scenarios selected for modeling purposes in PRZM/EXAMS were used to represent the maximum application rates for all ethaboxam uses. Table 3.7 presents the model inputs for application type and method as well as the scenarios selected for each modeled use.

Table 3.7. PRZM/EXAMS Model Input Parameters for Ethaboxam Application Methods

Use Scenario Seed Application

Rate (fl oz per cwt seed) Seed (lbs/ac) Field Applicat

ion Rate

(lbs a.i./ac) Date of

Initial App. App.

Method (CAM) 1

Cereal grains IAcorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Legume vegetables ILbeans 0.6 411 (garden

pea) 0.062 1 month preceding

emergence 4

Cereal grains ILcorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Cereal grains INcorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Cereal grains KScorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Cereal grains KSsorghum 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Legume vegetables MIbeans 0.6 411 (garden

pea) 0.062 1 month preceding

emergence 4

Cereal grains MNcorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Cereal grains MScorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Legume vegetables MSsoybean 0.6 411 (garden

pea) 0.062 1 month preceding

emergence 4

Cereal grains NCcorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Rapeseed NDcanola 0.3 8.2 (rape) 0.000615 1 month preceding

emergence 4

Cereal grains NDwheat 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Cereal grains NEcorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Cereal grains OHcorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

Legume vegetables ORsnapbeans 0.6 411 (garden 0.062 1 month preceding 4- Page 28 of 68

- pea) emergence

Cereal grains PAcorn 0.3 156 (wheat) 0.0117 1 month preceding

emergence 4

1

– A Chemical Application Method (CAM) of 4 indicates the chemical is incorporated



### The aquatic EECs resulting from the proposed ethaboxam uses (listed in Table 3. 9 ) were used for risk estimation in this screening

- level assessment. Example model input and output supporting these values is provided in Appendix B

.

Table 3. 9

. Modeled Aquatic Surface Water 1

- in

- 10

- year EECs for Proposed Uses of

Ethaboxam

Uses Max. App. R ate (lbs a.i./A ) Peak (ppb) 21

- day (ppb) 60

- day (ppb)

Cereal grains (MS Corn) 0.0117 0.136 0.0 99 0.0 88

Legume vegetables (MS Soybean) 0.062 0. 538 0.438 0.333

Rapeseed (ND Canola) 0.000615 0.003 0.0 03 0.003



### Table 3. 10 . Modeled Aquatic Sediment Pore Water 1

- in

- 10

- year EECs for Proposed Uses

of Ethaboxam

Uses Max. App. Rate (lbs a.i./A ) Peak (ppb) 21

- day (ppb) 60

- day (ppb)

Cereal grains (MS Corn) 0.0117 0.044 0.0 44 0.0 4 4

Legume vegetables (MS Soybean) 0.06 2 0. 06 3 0. 06 3 0. 061

Rapeseed (ND Canola) 0.000615 0.00 2 0.00 2 0.00 2



### 3.2. 3

. Measures of Terrestrial Exposure

3.2.3.1

. Terrestrial Wildlife

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals, emphasizing a dietary exposure route for uptake of the pesticide active ingredient. Birds are considered surrogates for terrestrial

- phase amphibians as well as reptiles. For exposure to terrestrial organisms from seed tr eatments, estimation of pesticide residues in or on seeds as food items assumes organisms are exposed to a single pesticide residue in a given exposure scenario and focuses on the possible dietary ingestion of residues. For seed applications, estimation o f loadings of ethaboxam per unit area is calculated based on known or estimated seeding rates

. This approach, which intends to represent exposures via multiple routes and not just direct ingestion, considers observed acute effects (acute oral LD 50 

### ) in terrestrial toxicology studies and relates them to the surface area where the pesticide is applied (LD 50 

### /ft 2 

### ).

T

- REX is used to calculate dose

- based EECs of ethaboxam for mammals and birds consuming treated seeds. Seeding rates as well as maximum ethaboxa m application rates according to the proposed label for the major uses of ethaboxam are provided in Table 3.11 . Other seed- Page 29 of 68

- 

### treatment use patterns are an order of magnitude below on a per acre basis. Estimated avian and

mammalian doses of ethaboxam as det ermined using T

- REX are also provided in the table for small (20 g birds and 15 g mammals), medium (100 g brids and 35 g mammals), and large (1000 g birds and mammals) animals

.

Table 3. 11

. Ethaboxam application rates and corresponding avian and mammalia n doses as determined using maximum proposed treatment rates and T

- REX.

Animal

Size Crop Ethaboxam application

rate (lbs. a.i./A) Maximum

Seed Application

Rate (mg ai/kg seed) Avian Dose (mg

ai/kg

bw/day) Mammalia n Dose (mg ai/kg

bw/day) Availabl e AI (mg

ai /ft 2 )

Small

Pea, garden 0.05 133.54 33.80 28.29

0.57 Medium 19.27 19.55

Large 8.63 4.53

Small

Wheat, all 0.01 57.87 14.62 12.26

0.09 Medium 8.35 8.47

Large 3.74 1.96

Small

Canol a 0.0062 66.77 16.90 14.15

0.02 Medium 9.64 9.78

Large 4.31 2.27



### T

- REX is also used to calculate EECs for terrestrial invertebrates, using the honey bee ( Apis mellifera ) as a surrogate species, exposed to ethaboxam . However, this method of calculation is only applicable to foliar uses that may result in contact exposure to terrestrial invertebrates. In addition, data from the registrant suggests that ethaboxam is not a systemic fungicide, suggesting

that residues of the chemical are unlikely to be found in the plant where they may be consumed by terrestrial invertebrates

, i.e., the honey bee (MRID 48535704 ). Therefore, ethaboxam exposures to terrestrial invertebrates are not quantitatively calculated for derivation of deterministic RQs. However, potential risk s to this taxon are assessed qualitatively in the Risk Description, Section 4.2.

3. 2

. 3.2. Terrestrial Plants

Exposure of naturally

- occurring terrestrial and semi

- aquatic (wetland) plant species is typically estimated using OPP’s TerrPlant (v1.2.2 ; US EPA, 2006b ) model and is assumed to encompass

areas outside the immediate use site. The TerrPlant model is used to derive EECs in runoff and

drift for terrestrial and semi

- aquatic plants near areas where ethaboxa m has been applied. Runoff exposure is assessed in two scenarios: sheet and channel runoff. In the sheet runoff scenario, the treated area generating runoff is assumed to drain into an area with equal size containing seedlings, resulting in 1, 2, or 5% o f the a mount applied being deposited. In the channel runoff scenario, a ten

- to

- one ratio of treatment area to receiving area results in 10, 20, or

50% of the amount applied being deposited on soil with emerging or emerged seedlings. Spray- Page 30 of 68

- 

### drift is also a source of pesticide loading to non

- target areas. There is an assumption that no spray drift is associated with seed tre atment. Data on the toxicity of ethaboxam to terrestrial plants have not been submitted to the agency. Potential for risks to terrestri al plants will be dicussed in the Risk Description

, Section 4.2

.

3.3

. Ecological Effects Characterization

In screening

- level ecological risk assessments, effects characterization describes the types of effects a pesticide can have on aquatic and terrestrial organisms. To date, toxicity tests for amphibian or reptiles are not required; birds are used as surrogates for reptiles and terrestrial

phase amphibians and freshwater fish are used as surrogates for aquatic

- phase amphibians. This characterization is based on the registrant

- submitted toxicity data for birds, mammals, fish, and

invertebrates for ethaboxam

. Additional data were available in the IUPAC FootPrint database and are incorporated in the effects characterization where appropriate.

In addition to the data submitted in support of registration, the public version of ECOTOX (ECOTOXicity) database (USEPA, 20 11 ) was searched for additional toxicity data from the open literature. The ECOTOX database is a publicly

- available, quality

- assured, comprehensive tool for locating toxicity data from the open literature and is maintained by EPA Mid

- Continent Ecology Divisi on. More information on ECOTOX can be found at: http://www

. epa.gov/ecotox

. Research papers are thoroughly screened using standard procedures before being accepted into ECOTOX thereby ensuring consistent, high quality information. For ethaboxam and its degradates, no studies were identified in ECOTOX as of February 26, 2013

.

Given that ethaboxam is a new active ingredient with no previous registration in the U.S., it is assumed that no ecological incidents exist for ethaboxam

.

3.3. 1

. Aquatic Toxicity Assessment

The most sensitive acute and chronic effects measurement endpoints available for ethaboxam exposure to freshwater and estuarine/marine species are summarized in Table 3.1 3

. All acceptable and supplemental studies availa ble for the registration of ethaboxam are described

below

3.1 3 . Summary of most sensitive endpoints from submitted aquatic toxicity studies for ethaboxam

. Exposure
Scenario Species Exposure

Duration Toxicity Reference

Value Effects Test

Substance Reference Toxicity Category

Freshwater Fish

Acute Rainbow trout

( Oncorhynchus mykiss ) 96 hours LC 50 = 2.18 m g a.i./L Mortality TGAI MRID

48535614 Acceptable Moderately

Toxic

Chronic Fathead minnow

( Pimephales 30 days NOAEC = 0. 88 m g a.i./L

LOAEC = 2.8 m g ai/L Cumulative mortality and clinical signs TGAI MRID

48535622 Acceptable NA- Page 31 of 68

- 3.1 3 . Summary of most sensitive endpoints from submitted aquatic toxicity studies for ethaboxam

. Exposure
Scenario Species Exposure
Duration Toxicity Reference

Value Effects Test

Substance Reference Toxicity Category

promelas ) of toxicity

Freshwater Invertebrates

Acute Daphnid

( Daphnia magna ) 48 hours EC 50 = 0. 37 m g a.i./L Mortality TGAI MRID

48535616 Acceptable Highly

Toxic

Chronic Daphnid

( Daphnia magna ) 21 days NOAEC = 0.05 mg a.i./L LOAEC = 0.1 mg a.i./L Time to first brood release, total offspring produced, and total offspring produced per reproductive day TGAI MRID

48535620 Acceptable NA

Benthic Organisms

Chronic Midge

( Chironomus

riparius ) 28 days NOAEC = 0.030 mg

TRR/L

LOAEC = 0.063 mg

TRR/L Mortality and

Growth TGAI MRID

48793901

Supplemental

(for qualitative use) NA

Estuarine/Marine Fish

Acute

Sheepshead

minnow

( Cyprinidon variegates ) 96 hours LC 50 > 3.1 mg a.i./L Mortality TGAI MRID

48535617 Supplemental (for quantitative use) Moderately

Toxic

Chronic Sheepshead

minnow

( Cyprinidon variegates ) 34 days NOAEC = 0.17 mg a.i./L LOAEC = 0.42 mg a.i./L Length and wet and dry

weight TGAI
MRID

48535623 Acceptable NA

Estuarine/Marine Invertebrates

Acute Eastern Oyster ( Crassostrea

virginica ) 96 hours EC 50 = 0.37 mg a.i/L Growth TGAI MRID

48535618 Acceptable Highly

Toxic

Acut e Mysid shrimp

( Mysidopsis bahia ) 96 hours LC 50 = 0. 50 mg a.i./L Mortality TGAI MRID

48535619 Acceptable Highly

Toxic

Chronic An acceptable estuarine/marine chronic toxicity study is not available; therefore, an acute

- to

- chronic ratio (ACR) from the daphnid will be applied to the most sensitive acute estuarine/marine endpoint for the eastern oyster. The resulting value of 0.05

mg a.i./L will be used in risk estimation. 0.37 mg a.i./L (acute daphnid endpoint) ÷ 0

. 05 mg a.i./L (chronic daphnid endpoint) = 0.37 mg a.i./L (acute eastern oyster endpoint) ÷ X (chronic value of interest) . X = 0.05 mg a.i./L Aquatic Plants- Page 32 of 68

- 3.1 3 . Summary of most sensitive endpoints from submitted aquatic toxicity studies for ethaboxam

. Exposure
Scenario Species Exposure
Duration Toxicity Reference

Value Effects Test

Substance Reference Toxicity Category

Acute Lemna gibba

-- -- -- -- -- Acute Pseudokirchneriell a subcapitata 96 hours NOAEC = 1.8 mg a.i./L

EC 50 > 3.6 mg a.i./L Cell density TGAI MRID

48535630 Acceptable Toxicity categories

are not specified for plants



### 3.3.1.1 Toxicity to Freshwater Fish

In a 96

- h acute toxicity study (MRID 48535614; Acceptable) , rainbow trout ( Oncorhynchus mykiss ) were exposed to ethaboxam at mean measured concentrations of <0.007 (<LOD, negative and solvent control), 0.072, 0.14, 0.28, 0.59, 1.2, 2.4 and 4.8 mg /L. The 96

- h LC 50 

### was 2.18 mg/L. There were no mortalities in the controls and 0.14 and 0.28 mg/L treatment groups.

No sub

- lethal effects were observed in the controls and mean

- measured 0.072 and 0.14 mg ai/L

treatment groups ; however, sublethal effects (e.g., lethargy, lo ss of equilibrium, hyperventilation, increased pigmentation, exophthalmia, irregular swimming) were observed in the 0.28

- 4.8 mg ai/L treatment groups. The NOAEC values based on sub

- lethal e ffects was 0.14 mg/L

. Based on these results, ethaboxam can be cate gorized as moderately toxic to rainbow trout on an acute

basis

.

In a second 96

- h acute toxicity study (MRID 48535615; Acceptable) , fathead minnows ( Pimephales promelas ) were exposed to ethaboxam a t a mean measured concentration of 4.6 mg

ai/L (the limit of solubitlity under study conditions) . The 96

- h LC 50 

### was >4.6 mg ai/L. No sub

lethal effects (e.g., lethargy, loss of equilibrium, on the bottom of the test vessel) were observed

in the controls and mean

- measured 4.6 mg ai/L treatment groups. Based on the results of this study, ethaboxam would be classified as nontoxic to Pimephales promelas at the limit of its solubility. Based on these results, ethaboxam can be categorized as moderately toxic to fathead

minnows on an acute basis.

Additional data are ava ilable in the Foot p rint database for bluefill sunfish ( Lepomis macrochirus ) exposed to ethaboxam in a 96

- hour toxicity study. The resulting LC50 was 0.102 mg a.i./L, which indicate that ethaboxam is highly toxic to bluegill. These data should be submitted to the Agency for review.

The 33

- day chronic toxicity of ethaboxam to the early life

- stage of fathead minnow ( Pimephales promelas ) was studied under flow

- through conditions (MRID 48535622; Acceptable) . Fertilized eggs/embryos (60/level, < 48 hours old) were exposed to ethaboxam at m ean

- measured

concentrations of <0.004 (<LOD, solvent control), 0.027, 0.089, 0.27, 0.88, and 2.8 mg ai/L

. The LC 50 

### for post

- hatch survival was 1.5 mg ai/L. The 33

- day NOAEC and LOAEC values were 0.88 and 2.8 mg ai/L, respectively, based on a treatment

- related increase in mortality accompanied by clinical signs of toxicity at the 2.8 mg ai/L level. Treatment

- related clinical signs of toxicity were observed at the 2.8 mg ai/L level and included curvature of the sp ine,- Page 33 of 68

- 

### inactivity, loss of equilibrium, and moribund condition. There were no treatment

- related effects on either length or dry weight of surviving fry at 28

- days post

- hatch.

3.3.1.2. Toxicity to Freshwater Invertebrates

In a 48

- hour acute toxicity stu dy (MRID 48535616; Acceptable), daphnids ( Daphnia magna ) under static conditions were exposed to ethaboxam at mean

- measured concentrations of <0.007 (<LOD, negative and solvent controls), 0.073, 0.14, 0.28, 0.53, 1.1 and 2.1 mg ai/L.

Immobilization was 0% in the controls and 0.073 and 0.14 mg ai/L treatment groups and was 5% in the 0.28 mg ai/L treatment group and 100% in the 0.53

- 2.1 mg ai/L treatment groups. The 48

- hour EC 50 

### and NOAEC values were 0.37 and 0.28 mg ai/L, respectively. Based on the results of this study, ethaboxam would be classified as highly toxic to Daphnia magna

.

The 21

- day

- c hronic toxicity of ethaboxam to Daphnia magna was studied under static

- renewal

conditions (MRID 48535620; Acceptable) . Daphnids were exposed at mean

- measured

concentrations of <0.0010 (<LOD, controls), 0.0062, 0.013, 0.025, 0.050, and 0.10 mg ai/L

. The

21

- day LC 50 

### for adult survival was > 0.10 mg ai/L. The 21

- day EC 50 

### for reproduction (offspring production per daphnia) was 0.083 mg ai/L

. The NOAEC and LOAEC were 0.050 and 0.10 mg ai/L, respectively, based upon a treatment

- related reduction in offspring production accompanied by a delay in the time to first brood release at the 0.10 mg ai/L level

. Survival remained at 100% for all levels throughout t he study and there were no treatment

- related effects on growth of adults (total length and dry weight) at any concentration level.

In a 28

- day chronic toxicity study (MRID 48793901; Supplemental for qualitative use), midges ( Chironomus riparius ) were expo sed to ethaboxam under static conditions at nominal

concentrations of 0 , 0.01 9 , 0.038, 0.075, 0.15, and 0.30 mg total radioactive residues ( TRR ) /L.

The NOAEC and LOAEC based on the time

- weighted average concentration was 0.030 and 0.063 mg TRR/L, respectiv ely, based on developmental rate. These data may be used qualitatively only because the study was designed to represent a single exposure from spray drift (spiked water) and does not address exposure from run

- off or multiple exposure events. In addition, t he study does not report effects on reproductive endpoints, which may be more

sensitive to ethaboxam.

3.3.1.3. Toxicit y to Estuarine/Marine Fish

In a 96

- h acute toxicity study (MRID 48535617; Supplemental) , sheepshead minnows ( Cyprindon variegatus ) were exposed to ethaboxam at a mean measured concentration of 3.1 mg

ai/L. This study was classified as supplemental because it was not clear whether the concentration tested represented the limit of solubility for ethaboxam under test conditions. The

96

- h LC 50 

### was >3.1 mg ai/L. There no mortalities in the controls and 3.1 mg ai/L treatment group. No sub

- lethal effects (e.g., lethargy, loss of equilibrium, on the bottom of the test vessel)

were observed in the controls and mean

- measured 3.1 mg ai/L treatm ent groups. Based on the- Page 34 of 68

- 

### results of this study, ethaboxam would be classified as moderately toxic to Cyprindon variegatus on an acute exposure basis

.

The 34

- day chronic toxicity of ethaboxam to the early life

- stage of sheepshead minnow ( Cyprinodon varieg atus ) was studied under flow

- through conditions (MRID 48535623; Acceptable ) . Fertilized sheepshead minnow embryos (80/level, <24 hours old) were exposed at

m ean

- measured concentrations of <0.0300 (<LOQ, controls), 0.067, 0.17, 0.42, 1.0, and 2.1 mg ai/L, respectively. Th e overall NOAEC and LOAEC were 0.17 and 0. 42 mg ai/L, respectively,

based on treatment

- related reductions in length and wet and dry weight of surviving f ry (most sensitive endpoints).

Mean hatching success was 98 and 100% for the negativ e and solvent control levels, respectively, and 95, 95, 98, 95, and 46% for the mean

- measured 0.067, 0.17, 0.42, 1.0, and 2.1 mg ai/L treatment levels, respectively. The difference was statistically

- significant (p≤0.05) compared to the negative control at the 2.1 mg ai/L treatment level. Post

- hatch larval survival averaged 99 and 98% for the negative and solvent control levels, respectively, and 97, 100, 100, 89, and 0% for the mean

- measured 0.067, 0.17, 0.42, 1.0, and 2.1 mg ai/L treatment levels,

respec tively. A statistically

- significant (p≤0.05) difference compared to the negative control was detected at the 2.1 mg ai/L treatment level.

No treatment

- related effect on the time to hatch was observed. Embryos began hatching on Day

5 of the test and al l surviving embryos from all levels had hatched by Days 6 to 9. All fish from the 1.0 mg ai/L level appeared weak on day 0 post

- hatch, and approximately 26% of the fish from this level exhibited signs of toxicity, including small size, weakness, lethargy, lying at the bottom of the chamber, swimming erratically, surfacing, fin pecked, or loss of equilibrium by the end of the test. All fish from the 2.1 mg ai/L level were dead by day 6 post

- hatch.

Statistically

- significant reductions in length were obse rved at the 0.42 mg ai/L level compared to the negative control (p≤0.05). Total lengths averaged 20.5 to 21.2 mm for the negative control though 0.17 mg ai/L levels, 20.1 mm at the 0.42 mg ai/L level, and 19.4 mm at the 1.0 mg ai/L level. Statistically

- si gnificant reductions in wet and dry weights compared to the negative control were observed at all treatment levels. Wet weights averaged 104.2 to 113.0 mg for the negative control though 0.17 mg ai/L levels, 98.3 mg at the 0.42 mg ai/L level, and 88.1 mg at the 1.0 mg ai/L level; and dry weights averaged 24.3 to 26.7 mg for the negative control through 0.17 mg ai/L levels, 23.6 mg at the 0.42 mg ai/L level, and 21.8 mg at the 1.0 mg ai/L level.

3.3.1.4. Toxicity to Estuarine/Marine Invertebrates

In a 96

- h acute toxicity test (MRID 48535618; Acceptable), Eastern oysters ( Crassostrea virginica ) were exposed to ethaboxam at mean

- measured concentrations of <LOQ, (<0.0100 mg ai/L, controls), 0.027, 0.068, 0.17, 0.42, 1.1 and 2.6 mg ai/L. The E C 50 

### for shell deposition was 0.37 mg a.i./L. Based on these data ethaboxam would be classified as highly toxic to the Eastern oyster on an acute exposure basis.- Page 35 of 68

- 

### In an addition 96

- h acute toxicity study (MRID 48535619; Acceptable), mysid shrimp ( Mysidopsis bahia ) were exposed to ethaboxam at nominal concentrations of 0 (negative control), 0 (solvent control), 0.063, 0.13, 0.25, 0.50 and 1.0 mg ai/L. The LC 50 

### was 0.50 mg a.i./L. based on these data ethaboxam would be classified as highly toxic to the mysid shrimp on

an a cute exposure basis.

In 32

- day invertebrate life

- cycle study (MRID 48535621 ; Invalid ), mysid shrimp were exposed

to ethaboxam at mean

- measured concentrations of <0. 3 00 (<LOQ, controls), 0.42, 0.97, 2.1, 4.3, and 9.6 μ g ai/L

. This study was classified as invalid because of poor reproductive performance by females in all treatment and control groups, suggesting potentially compromised lab cultures.

Because a n acceptable estuarine/marine chronic toxicity study is not available, an acute

- to

chronic ratio (A CR) from the daphnid of 7.4 will be applied to the most sensitive acute estuarine/marine endpoint for the eastern oyster ( 0.37 mg a.i./L (acute daphnid endpoint) ÷ 0.05 mg a.i./L (chronic daphnid endpoint))

. The resulting value of 0.05 mg a.i./L will be u sed in risk

estimation.

3.3.1.5. Toxicity to Aquatic Plants

In a 96

- hour acute toxicity study (MRID 48535630; Acceptable) , cultures of freshwater green algae, Pseudokirchneriella subcapitata strain CCAP 278/4, were exposed to ethaboxam at mean

measured concentrations of 0.007 (<LOD, negative and solvent controls), 0.23, 0.47, 0.96, 1.8, and 3.6 mg/L. The NOAEC and EC 50 

### /IC 50 

### values based on cell density, growth rate, and area under the curve were 1.8and >3.6 mg a.i. /L, respectively. The % growth inhibition of cell density in the treated algal culture as compared to the negative control ranged from 7 to 25%.

Additional data are available on the Foot p rint database for Raphidocelis subcapitata , another freshwater algal species, exposed to ethabox am for 72 hours. While a NOAEC value is not provided, the EC50 value based on growth is 0.009 mg a.i./L, which indicate that R. subcapitata is considerably more sensitive to ethaboxam than P. subcapitata

.

3. 3.2 Terrestrial Effects Characterization

The most sensitive acute and chronic toxicity reference values available for ethaboxam exposure to mammals, birds, and terrestrial in vertebrate s are summarized in Table 3.1 4 . Terrestrial plant

data has not been submitted for ethaboxam. All acceptable and supplemental studies available for the registration of ethaboxam are described below

.

Table 3.14 Summary of most sensitive endpoints from submitted terrestrial toxicity studies

for ethaboxam

. Species (common

name) Taxa Represented Endpoint Effect Test

Substance

(% a.i.) Reference/

Classification Acute Toxicity

Classification- Page 36 of 68

- 

### Table 3.14 Summary of most sensitive endpoints from submitted terrestrial toxicity studies

for ethaboxam

. Species (common

name) Taxa Represented Endpoint Effect Test

Substance

(% a.i.) Reference/

Classification Acute Toxicity

Classification

Rattus norvegicus (Laboratory Rat) Mammals Acute Oral LD 50 > 5000 mg a.i./kg

- bw No toxicity TGAI MRID#

46378518 Acceptable Practically

non

- toxic

NOAE L = 16.2 mg a..i/kg/day Testicular

lesions and

reduced fertility in

F 1 males

and

decreased

body weight in F1 pups

and

decreased viability of

F1 and F2

males during

lactation. TGAI MRID#

46387804 Acceptable NA

LOAE L = 52.6 mg a.i./kg/day

Bobwhite quail ( Colinus

virginianus )

Birds,

terrestrial

phase amphibians, and reptiles LD 50 > 2000 mg a.i./kg bw No toxicity TGAI MRID#

48535607 Acceptable Practically

non

- toxic

Zebra finch ( Taeniopygia

guttata ) LD 50 > 2000 mg a.i./kg

- bw No toxicity TGAI MRID

48535608 Supplemetnal Practically

non

- toxic

Bobwhite quail ( Colinus

virginianus ) LC 50 > 5080 mg a.i./kg diet No toxicity TGAI MRID#

48535609 Acceptable Practically

non

- toxic

Bobwhite quail ( Colinus

virginianus ) NOAEC = 170 mg a.i./kg

- diet eggs laid,

eggs set,
ratio of

eggs set to eggs laid,

viable embryos,

live embryos,

number hatched,

and hatchling

survivors TGAI MRID#

48535613 Acceptable Not Applicable LOAEC = 415 mg a.i./kg

- diet

Honey bee ( Apis mellifera ) Terrestrial

invertebrates Contact LD 50 >
111.8 μg a.i./bee No toxicity TGAI MRID#

48535627 Acceptable Practically

non

- toxic- Page 37 of 68

- 

### Table 3.14 Summary of most sensitive endpoints from submitted terrestrial toxicity studies

for ethaboxam

. Species (common

name) Taxa Represented Endpoint Effect Test

Substance

(% a.i.) Reference/

Classification Acute Toxicity

Classification

Oral

LD 50 > 111.8 μg a.i./bee No toxicity TGAI Practically

non

- toxic

Contact LD 50 = 51 μg a.i./bee Mortality TGAI Footprint 1 Toxic

1 Data have not been submitted to the Agency for review.



### 3.3.2.1. Toxicity to Mammals

Mammalian toxicity data submitted to the Agency ’ s Health Effects Division (HED) are used to approximate toxicity to wild mammals. These studies are typically conducted with laboratory rats ( Rattus norvegicus ) or mice ( Mus musculus ). No studies evaluating toxicity to wild mammal species are available, or have been submitted to the Agency for ethaboxam

.

The reported laboratory rat acute oral LD 50 

### value is greater than 5000 mg/kg

- bw (MRID

46378518 ). Based on the reported non

- definitive laboratory rat oral LD 50 

### value

, ethaboxam may be classified as “practically non

- toxic” t o small mammals.

In the available 3

- generation rat reproduction study, the NOAE L is 16.2 mg a.i./k g/day based on testicular lesions, reduced fertility in F 1 

### males, decreased body weight in F1 pups, decreased viability of F1 and F2 males during lactation, decreased F1 pup body weight and body weight gain (MRID 46387804 ).

3.3.2.2. Toxicity to Birds

The acute oral toxicity of ethaboxam to ca . 10

- month old Northern bobwhite quail ( Colinus virginianus ) was assessed over 14 days (MRID 48535607; Acceptable)

. Ethabocam technical was administered to the birds by oral gavage at nominal levels of 0 (vehicle c ontrol), 500, 1000, and 2000 mg a

. i

. /kg bw. The 14

- day acute oral LD 50 

### was >2000 mg a.i. /kg bw. The NOAEL

value based on weight gain was 1000 mg a.i. /kg bw due to reduced body weight gain corresponding to a reduction in feed consumption for both male and f emale birds at the 2000 mg a.i./kg bw dosage level. Ethaboxam would be classified as practically non

- toxic to young adult Northern bobwhite quail ( Colinus virginianus ) on an acute exposure basis

.

In a second study, t he acute oral toxicity of ethaboxam t o ca . 5 to 9

- month old zebra finch ( Taeniopygia guttata ) was assessed over 14 days (MRID 48535608; Acceptable)

. Ethaboxam technical was administered to the birds by gelatin capsule at nominal levels of 0 (control) and 2000 mg ai/kg bw. The 14

- day acute ora l LD 50 

### was >2000 mg a

. i

. /kg bw. The NOAEL was 2000

mg a

. i

. /kg bw based on weight gain and food consumption

. Ethaboxam is classified as practically- Page 38 of 68

- 

### non

- toxic to young adult zebra finch ( Taeniopygia guttata )

.

In a sub

- acute dietary study, the toxicity of ethaboxam to bobwhite quail was assessed over 8 days (MRID 48535609 ; Acceptable). No test substance related mortality was observed in the control group or any of the treatment groups throughout the 8

- day test p eriod. The 8

- day acute dietary LC 50 

### was >5080 mg ai/kg diet. No clinical signs of toxicity were observed ; however,

r eductions in bodyweight gain (Days 0 to 5) and feed consumption (Days 1 to 2) were observed in the 5080 mg ai/kg treatment group. Ethaboxam is classified as practically non

- toxic to juvenile Northern Bobwhite quail ( Colinus virginianus ).

The one

- generation reproductive toxicity of ethaboxam to 20 pairs per level of ca . 10

- month old Northern bobwhite quail ( Colinus virginianus ) was assessed ov er 22 weeks (MRID 48535612; Acceptable)

. Ethaboxam technical was administered to the birds in the diet at mean

- measured

concentrations of <3.75 (LOD, control), 99, 304, and 993 mg ai/kg diet. A total of nine

mortalities were observed in the control and tre atment groups; none were considered related to

the treatment. No overt signs of toxicity were observed in any of the treatments. There were no

treatment

- related differences in feed consumption or in adult body weight gain and hatchlin g bodyweight at any treatment level. There were no treatment

- related differences for offspring hatchability or survival parameters.

In a second study, t he one

- generation reproductive toxicity of e thaboxam to 16 pairs per level of

19

- week old mallard duck ( Anas platyrhynchos ) was assessed over 21 weeks (MRID 48535613; Acceptable) . Ethaboxam was administered to the birds in the diet at m ean

- measured

concentrations of <20 (LOQ, control), 170 ± 15.2, 419 ± 28.0, and 1050 ± 95.9 mg ai/kg diet.

There were no treatment

- related mortalities, overt signs of toxicity, or treatment

- related effects upon body weight or feed consumption in the control and treatment groups. No treatment

- related effects upon any of the reproductive parameters were observed at the 170 mg ai/kg treatment group. Treatment

- related reductions in egg production were observed in the 419 and 1050 mg ai/kg treatment groups, which ultimately led to further, more sensitive reductions in offspring hatchability and survival parameters at the same leve ls. Affected endpoints (p<0.05) included eggs laid, eggs set, ratio of eggs set to eggs laid, viable embryos, live embryos, number hatched, and hatchling survivors. No treatment

- related differences upon eggshell thickness, offspring body weights, or other relative reproductive parameters were observed at any treatment level. The NOEL for parental toxicity and reproduction endpoi nts was 170 mg ai/kg diet.

3.3.2.3. Toxicity to Terrestrial Invertebrates

In a 48

- h oral toxicity study (MRID 48535627; Acceptable), honey bees ( Apis mellifera ) were exposed to ethaboxam at a mean

- measured concentration of 111.8 μg a.i./bee via a sucrose

solution treated with ethaboxam. No mortality was observed for the untreated control grou ps. No mortality was observed for the 111.8 μ g a.i. ethaboxam/bee treatment level or the 0.04 and 0.08

μ g dimethoate/bee treatment levels. No behavioral abnormalities were observed. The 48

- hour

LD 50 

### of Ethaboxam was >1 11.8 μ g a.i./bee.- Page 39 of 68

- 

### Also submitted to the Agency was a contact toxicity test, which exposed honey bees to 111.8 μg a.i./bee in acetone applied to the ventral thorax (MRID 48535627; Acceptable). No mortality was observed for the untreated control groups. Mortality in the acetone/sucrose control groups ranged from 3.3 to 8.3% after 48 hours. No mortality was observed for the 111.8 μ g a.i. ethaboxam/bee

treatment level or the 0.04 and 0.08 μ g dimethoate/bee treatment levels. Mortality was 10%,
60%, and 93.3% for the 0.12, 0.16, and 0.32 μ g dimethoate/bee treatment levels. No behavioral

abnormalities were observed. The 48

- hour LD 50 

### of Ethaboxam was >100 μ g a.i./bee.

Additional data for the honey bee are available on the Footprint database. Based on observed mortaility in the 48

- hour contact study, the LD 50 

### was 51 μg a.i./bee, which would indicate that

ethaboxam is, in fact, toxic to honey bees. These data should be submitted to the Agency for

review.

An additional non

- guideline study was submitted describing the toxicity of ethaboxam to

ear thworms ( Eisenia fetida ) after 14 days of exposure (MRID 48535628; Supplemental).

E arthworms were exposed to ethaboxam at nominal concentrations of 0 (negative control), 95, 171, 309, 556, and 1000 mg a.i. /kg dryweight (dw) of soil. After 14 days of expos ure, there was 5, 2.5, 5, 2.5, and 0% mortality observed in the 95, 171, 309, 556, and 1000 mg a.i. /kg dw soil groups, respectively, compared to 0% mortality in the negative control. The LC 50 

### was >1000 mg

a

. i

. /kg dw of soil. Mean body weights (Days 0

- 14) were decreased by 9, 8, 15, 10, and 13% in the 171, 309, 556, and 1000 mg a.i. /kg dw soil groups, respectively, compared to 3% body weight loss in the control. The EC 50 

### was >1000 mg a

. i

. /kg dw of soil based on body weight losses. The NOAEC, based on sign ificant (p<0.05) body weight losses at the 309 and 1000 mg

a.i. /kg soil levels

, was 171mg a

. i

. /kg dw of soil.

3.3.2.4. Toxicity to Terrestrial Plants

Data on the toxicity of ethaboxam to terrestrial plants have not been submitted to the agency. Potential risks to this taxa will be discussed in the Risk Description, Section 4.2

.

4. Risk Characterization

4.1. Risk Estimation

Toxicity data and exposure estimates are used to evaluate the potential for adverse ecological

effects on non

- target species. This screening

- level assessment for ethaboxam relies on the deterministic RQ method to provide a metric of potential risks. The RQ provides a comparison

of exposure estimates to toxicity endpoints ( i.e. , the estimated exposure concentrations are divided by acute and chronic toxicity values). The resulting unitless RQs are compared to the Agency’s LOCs, as shown in Table 2.3

. LOCs are used by the Agency to indicate when the use of a pesticide, as directed by the label, has the potential to cause adverse effects to non

- target organisms.

4.1.1. Aquatic Organisms- Page 40 of 68

- 

### The highest scree n ing

- level aquatic EEC s based on the maximum application rates for each

propo sed use pattern w ere used to derive RQs. These exposure estimates represent

concentrations in surface water ( Table 3. 9 ). Peak EECs are used to represent acute exposure to fish, aquatic invertebrates, and aquatic plants, and the highest 21

- day and 60

- day average EECs represent chronic exposure to aquatic invertebrates and f ish, respectively. These EECs include

LGC

- 32799 , which occurs at 22.7% of applied radioactivity in the dark control of the soil photolysis study, as part of total toxic residues of etha boxam. However, this residue is potentially more toxic than ethaboxam ( Appendix D ). LCG

- 32533, LCG

- 32525, LGC

- 32523,

and LGC

- 35525 were not estimated to be as toxic as ethaboxam but are conservatively included

as total toxic residues in the absence of da ta.

4.1.1.1. Fish and Invertebrates

Results of acute toxicity studies in freshwater and estuarine/marine fish ( Table 3.13 ) indicate

that ethaboxam is “highly toxic” to freshwater and estuarine/marine invertebrates and “moderately toxic” to freshwater and estuarine/marine fish on an acute exposure basis

. Acute

and chronic RQ s for freshwater and estuarine/marine fish and invertebrates are all less than 0.01,

well below the Agency’s acute risk to listed species LOC (0. 0 5) , acute risk to non

- listed species

LOC ( 0.5 ), and chronic listed and non

- listed species LOC (1.0) for all of the p roposed uses

.

RQs for benthic aquatic invertebrates were not calculated because the available data are for qualitative use only. Potential risks to these taxa will be discuss ed in the Risk Description,

Section 4.2

. 4.1.1. 2

. Aquatic Plants

Although ethaboxam does exhibit effects on freshwater green algae, including Pseudokirchneriella subcapitata and Raphidocelis subcapitata

, these effects are at higher concentrations than those estimated for the highest proposed ethaboxam seed treatment use. The

l isted species RQ for P. subcapitata is <0.01, while the LOC is 1.0. The non

- listed species RQ

for R. subcapitata is 0.06, which is l ess than the LOC of 1.0. Data on a vascular aquatic species are not available. Uncertainties are discussed in the risk description in Section 4.2

.

4.1.2. Terrestrial Organisms

4.1.2.1. Mammals

Acute RQs were not calculated for mammals because only non

- definitive acute oral toxicity data are available. Based on the available acute toxicity data, no mortality was observed in any of the

mammalian studies conducted on ethaboxam technical at the hig hest concentrations/doses tested; as such, ethaboxam is categorized as “practically nontoxic” to mammals on an acute exposure
basis. Further discussion of the predicted exposure values relative to the levels at which no mortality was observed is provided as part of the risk description in Section 4.2.4.- Page 41 of 68

- 

### Based on the propo sed maximum application rates, combined with th e amount of seed per acre, the highest exposures occurred for the legume vegetables ( e.g., garden peas), resulting in the highest chronic RQ s across all uses of 0. 79 , less than the chronic risk LOC of 1.0. Table 4. 2

lists maximum chronic exposure mammal RQs for all of the proposed uses based on the upper

90 th 

### percentile Kenaga values. These RQs all fall below the Agency’s mammalian chronic r isk

to listed and non

- listed species chronic risk LOC (1.0).

Table 4. 2 . Chronic Mammalian Risk Quotients for Ethaboxam Proposed Use as a Seed Treatment

Animal

Size Crop Ethaboxam application

rate (lbs. a.i./ A ) Maximum Seeding Rate (lbs seed/acre) Mammalian Dose (mg ai/kg

- bw/day) Mammalian RQs 15g

Pea, garden 0.05 133.54 28.29 0.79 35g 19.55 0.68 1000g 4.53 0.36

15g

Wheat 0.01 57.87 12.26 0.34 35g 8.47 0.29 1000g 1.96 0.16

15g

Canola 0.0062 66.77 14.15 0.40 35g 9.78 0.34 1000g 2.27 0.18



### 4.1.2.2. Birds

Acute RQs were not calculated for birds because only non

- definitive acute and sub

- acute toxicity endpoints are available. Ethaboxam is categorized as “ practically non

- toxic ” to zebra

- finch, bobwhite quail , and mallard duck on an acute and subacute oral and dietary basis. T reatment

related sublethal effects were observed in mallard duck and bobwhite quail studies at the highest

concentration s tested ; however these concentrations were above the typical limit dose for avian

acute and sub

- acute dietary toxicity stud ies. These effects (noted previously) will be discussed further, relative to potential exposure, in the Risk Description section, but acute risk to avian species is expected to be low.

Based on the pr opo sed maximum application rates, combined with th e amount of seed per acre, the highest exposures occurred for the legume vegetables ( e.g., garden peas), resulting in the highest chronic RQs across all uses of 0.79

, which is below the chronic risk LOC of 1.0. Table

4. 2 lists maximum chronic exposure RQs for all of the proposed uses based on the upper 90 th


### percentile Kenaga values.- Page 42 of 68

- 

### Table 4. 2 . Chronic Avian Risk Quotients for Ethaboxam Proposed Use as a Seed

Treatment

Animal

Size Crop Ethaboxam application

rate (lbs. a.i./ A ) Maximum Seeding Rate (lbs seed/acre) Avian Dose (mg ai/kg

- bw/day) Avian RQs 1

20g

Pea, garden 0.05 133.54 33.80

0.79 100g 19.27

1000g 8.63

20g

Wheat 0.01 57.87 14.6 5

0.34 100g 8.35

1000g 3.74

20g

Canola 0.0062 66.77 16.90

0. 39 100g 9.64

1000g 4.31

1 Chronic RQs are not adjusted for weigth class for birds as no data exits for incorporating scaling factors.



### 4.1.2.3

. Terrestrial Invertebrates

RQs were not calculated for flying terrestrial invertebrates because use of ethaboxam as a seed treatment is not likely to result in contact exposure to non

- soil dwelling terrestrial invertebrates, such as the surrogate species the honey bee and data from the registrant indicate that ethabo xam is not a systemic fungicide and would therefore not be found in parts of the plants where they may be consumed by terrestrial invertebrates (MRID 48535704). Based on this information, exposure to flying terrestrial invertebrates is unlikely from the pr oposed seed treatment use.

4.1.2.4

. Non

- target Terrestrial Plants

Potential effects to riparian and upla nd vegetation are assessed deriving RQs from terrestrial plant seedling emergence and vegetative vigor EC 25 

### and NOEAC endpoints

. However, these

data a re not currently available . Characterization of exposure and potential toxicity will be discussed in the Risk Description section.

4.2. Risk Description

The results of risk estimation i ndicate that proposed uses of thaboxam are not likely to adversely

affect listed or non

- listed fish and aquatic invertebrates on both an acute and chronic exposure

basis. In addition

, risk s to terrestrial birds and mammals also appear to be below the Agency’s

levels of concern.

4.2.1 Exposure to Aq uatic Organisms- Page 43 of 68

- 

### The Tier II model Pesticide Root Zone Model (PRZM v3.12.2; May 12, 2005; Carousel et al.

, undated) linked with EXposure Analysis Modeling System (EXAMS v2.98.4.6; Apr. 25, 2005; Burns, 2004) via the PRZM/EXAMS model shell (PE v5.0, Nov. 15 , 2006), i.e.

, PRZM/EXAMS) was used to estimate screening

- level exposure concentrations in aquatic environments. The PRZM model simulates pesticide movement and transformation on and across the agricultural field resulting from crop applications. The EXA MS model simulates pesticide concentrations in water due to loading via runoff, erosion, and spray drift, assuming a

standard 1

- ha pond, 2

- m deep (20,000 m 3 

### ) with no outlet that borders a 10

- ha treated field. Simulations are for multiple (usually 30) year s, from which the Agency estimates peak values that are expected to recur on average once every ten years, based on time series of daily

estimated concentrations.

Model uncertainties are discussed in greater detail in Section 4.3

.

4.2.2 Risks to Aquatic Animals

R isks to aquatic systems from acute and chronic exposure to ethaboxam are expected to be low

. While ethaboxam is classified as “highly toxic” to aquatic invertebrates and “ moderately ” toxic to fish, across the freshwater and estu arine/marine systems, exposure for the seed treatment uses is expected to be sufficiently low so as to not trigger risk concerns (all RQs are < 0.01)

.

An available chronic midge study suggests that ethaboxam exhibits toxic effects on various growth and d evelopmental endpoints. U ncertainties in the study limit the data’s utility in risk

estimati o n; however, given that effects were observed in the mg/L range and modeled exposures are in the μg/L range, it is unlikely that there will be risks to benthic inve rtebrates from the proposed seed treatment uses of ethaboxam.

4.2.3 Risks to Aquatic Plants

Based on the available information on Pseudokirchneriella subcapitata , the proposed uses of

ethaboxam as a seed treatment do not exceed the Agency’s LOC for aquatic plant s (1.0) for nonlisted or listed plants. While RQs were not calculated in the Risk Estimation section due to

the lack of definitive IC 50 

### values, there were effects noted in the studies. The NOAEC among is

1

. 8 mg ai/L (based on biomass and cell density). At that concentration, the RQ is less than 0.01

whereas the LOC is 1.0.

However, data on a vascular aquatic species are not available. In addition, risk to aquatic nonvascular species is typically evaluated with not only the green algae species that was submitted, but also with a cyanobacteria , a centric diatom and a pinnate diatom. Acceptable studies with these species have not been sub mitted and are an appreciable source of uncertainty in the risk assessment. These planktonic taxa form the basis of the aquatic food web and are frequently more sensitive to pesticides than cyanobacteria. While these data gaps create appreciable uncertai nties in the effects characterization of ethaboxam, the additional non

-- Page 44 of 68

- 

### vascular and vascular species would need to be more than 4 orders of magnitude more sensitive than the green algae in order to trigger risk concerns for the proposed uses of ethaboxam a s seed

treatment. Therefore this data is not necessary at this time and risks to aquatic plants are expected to be low as a result of minimal exposure. However, this data would be necessary should the registrant submit a future registration request for an above

- ground spray application

of ethaboxam.

4.2.4. Exposure to Terrestrial Organisms

4.2. 5

. Risks to Mammals

Acute RQs were not calculated for mammals because only non

- definitive acute oral toxicity data are available. Based on the available acute toxicity data, no mortality was observed in any of the

mammalian studies conducted on ethaboxam technical at the hig hest concentrations/doses tested; as such, ethaboxam is categorized as “practically nontoxic” to mammals on an acute exposure
basis. Based on the propo sed maximum application rates, combined with th e amount of seed per acre, the highest exposures occurred for the legume vegetables ( e.g., garden peas), resulting in the highest chronic RQs across all uses of 0. 79 , less than the chronic risk LOC of 1.0.

The potential for direct mortality of nonlisted and listed mammals from acute, subacute and chronic expo sures of ethaboxam treated seed is not expected.

4.2. 6

. Risk to Birds

Acute RQs were not calculated for birds because only non

- definitive acute and sub

- acute toxicity endpoints are available. Ethaboxam is categorized as “ practically non

- toxic ” to zebra

- finch, bobwhite quail , and mallard duck on an acute aroal and subacute dietary basis. T reatment

related sublethal effects were observed in mallard duck and bobwhite quail studies at the highest

concentration s tested . Sublethal effects included a dec rease in food consumption and weight gain. However, the proposed use of ethaboxam as a seed treatment ( i.e., low application rate) combined with its relatively short half

- life in the terrestrial environment suggest that birds will not be exposed to suffici ent quantities of the chemical to elicit these sublethal responses.

The potential for direct mortality of nonlisted and listed birds (and to terrestrial

- phase amphibian and reptiles for which birds serve as surrogates) from acute, subacute and chronic ex posures of

ethaboxam treated seed is not expected.

4.2. 7

. Potential Effects on Terrestrial Invertebrates

RQs were not calculated for flying terrestrial invertebrates for several reasons, including: 1) only

non

- definitive toxicity endpoints are available, 2) use of ethaboxam as a seed treatment is not likely to result in contact exposure to non

- soil dwelling terrestrial invertebrates, such as t he- Page 45 of 68

- 

### surrogate species the honey bee, and 3) data from the registrant indicate that ethaboxam is not a systemic fungicide and would therefore not be found in parts of the plants where they may be consumed by terrestrial invertebrates (MRID 48535704). Based o n this information, exposure to flying terrestrial invertebrates is unlikely from the proposed seed treatment use.

For soil dwelling invertebrates , results of an acute study with earthworms yielded a 14

- day LC 50 

### value greater than 1000 mg ai/kg dw soil ( MRID 48535628; Supplemental)

. Though the actual concentrations earthworms were exposed to during the course of the study is uncertain, it is likely that the relatively low amounts of ethaboxam present in the soil on and around the treated

seed would not be enough to elicit a toxic response from earthworms and other subterranean

terrestrial invertebrates.

Based on the data available at this time, risks to non

- target flying and soil

- dwelling invertebrates resulting from the proposed use of ethaboxam are not expected

.

4.2. 8

. Risk to Terrestrial Non

- target Plants

Risks to terrestrial plants could not be assessed due to a lack of data

. The registrant submitted data waiver requests for both the seedling emergence and vegetative vigor data requirements (MRIDs 48535704 and 48535705, respectively), citing ethaboxam’s low field application rates as a seed treatment, relatively ra p i d soil half

- life (1.5 to 6.1 days depending on the soil) , and fungicidal mechanism of action. While the Agency did not grant the waive r request for the seedling emergence data because ethaboxam is chemically active during seed germination and may be transmitted off

- site via run

- off, supporting data provided by the registrant on seed germination in the presence of ethaboxam (memo data 10/ 15/2012) suggest that the relatively low application rate of ethaboxam as a seed treatment does not inhibit seed germination

. The Agency granted the waiver request for the vegetative vigor data because the seed treatment use is likely to result in limited exposure to plant foliage. However, seedling emergence and vegetative vigor data would be necessary should the registrant submit a future registration request for an

above

- ground spray application of ethaboxam.

4.3. Uncertainties and Data Gaps

4.3.1. Fate and Transport Unce r tanties

Submitted environmental fate stud ies represent application methods relevant to broadcast applications rather than seed treatments, the use pattern relevant to this new chemical registration. The formulation applied to the seed and interaction with the seed coat can impact the degradation and mobility of ethaboxam . In the absence of field or laboratory data demonstrating ethaboxam fate and transport on seed treatments, the rate and route of ethaboxam dissipation are uncerta inities

.

Major degradates of ethaboxam are structurally similar to ethaboxam and are conservatively- Page 46 of 68

- 

### assumed to be toxic residues. QSAR estimates from ECOSAR (in Appendix D ) indicate LGC

32799 to be approximately an order of magnitude more toxic than pare nt ethaboxam with other

two

- ring degradates predicted to be slightly less toxic (LGC

- 32533 and LGC

- 32525)

. Single

- ring degradates are predicted to be approximately an order of magnitude less toxic than ethaboxam (LGC

- 32523 and LGC

- 35525). Degradation est imates cannot be made because concentrations of degradate increase to study termination. An aged column leaching study indicates that degradates can leach through soil but further characterization of degradate mobility is not possible without further data . In the absence of specific degradate fate and transport data, the rate and route of ethaboxam degradate dissipation are uncertainties.

Submitted metabolism studies use only an acetone extraction and unextracted residues in aerobic

soil metabolism studi es are 55% to 70% of applied radioactivity by study termination. Without demonstrating additional extractions, the bioavailability of these unextracted residues is an uncertainty. An aerobic soil metabolism study employing additional extraction technique s is being submitted and preliminary results indicate lower unextracted residues. The review of this study has potential to reduce uncertainity associated with the unextracted residues.

4.3.2. Effects Uncertainties

There are several notable data gaps and uncertainties in the characterization of toxic effects for ethaboxam, including an incomplete dataset for aquatic vascular and non

- vascular plants, and a complete lack of terrestrial plant data. While potential exposure to ethaboxam from the proposed

s eed treatment uses is expected to be low enough to mitigate some of the concerns associated with these data gaps, these data would be necessary to assess risks from any future registration requests for an above

- ground spray applications of ethaboxam. In th e absence of this data risks to aquatic and vascular plants may be presumed.

In addition, chronic toxicity data for an estuarine/marine invertebrate are not available. Therefore, an acute

- to

- chronic ratio (ACR ) based on the daphnid was applied

. The ACR is considered protective for the purpose of this risk assessment; however, the application of an ACR in the absence of actual data does introduce uncertainty to the risk assessment.

5. Federally Threatened and Endangered (Listed) Species C oncern s

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, and/ or the United States Fish and Wildlife Service ( US FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated critical habitat. Each federal agency is required under the Act to ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued existence of a listed species means "to engage in an

action that reas onably would be expected, directly or indirectly, to reduce appreciably the- Page 47 of 68

- 

### likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species" (50 C.F.R. § 402.02).

To facili tate compliance with the requirements of the Endangered Species Act (subsection (a)(2)), the Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly appreciably reduce the likeli hood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species (USEPA, 2004). After the Agency’s screening level risk assessment is conducted, if any of the Agency’s list ed species ’ LOCs are exceeded for either direct or indirect effects, an analysis is conducted to determine if any listed or candidate species

may co

- occur in the area of the proposed pesticide use or areas downstream or downwind that

could be contaminated from drift or runoff/erosion. If listed or candidate species may be present in the proposed action area, further biological assessment is undertaken. The extent to which listed species may be at risk is considered

, which then determines the need for the development of a more comprehensive consultation package, as required by the Endangered Species Act.

The federal action addressed herein is the proposed new registration of ethaboxam on agricultural use sites ; it is expected that its use could occur natio nwide

.

5.1. Action Area

For listed species assessment purposes, the action area is considered to be the area affected

direct ly or indirectly by ethaboxam use and not merely the immediate area where ethaboxam is applied. At the initial baseline , the risk assessment considers broadly described taxonomic groups and conservatively assumes that listed species within those broad groups are co

- located with the pesticide treatment area. This means that listed terres trial plants and wildlife are assumed to be located on or adjacent to the treated site and listed aquatic organisms are assumed to be located in a surface water body adjacent to the treated site. The assessment also assumes that the listed species are loc ated within an assumed area, which has the relatively highest potential exposure to the pesticide, and that exposures are likely to decrease with distance from

the treatment area. Section 3.1 of this risk assessment presents the proposed pesticide use sit es that are used to establish initial co

- location of species with treatment areas.

5. 2

. Taxonomic Groups Potentially at Risk

If the assumptions associated with the baseline action area result in RQs t hat are below the listed species LOCs, a "no effect" determination conclusion is made with respect to listed species in that taxa, and no further refinement of the action area is necessary. Furthermore, RQs below the listed species LOCs for a given taxono mic group indicate no concern for indirect effects on listed species that depend upon the taxonomic group for which the RQ was calculated. However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential for a "may affect" conclusion exists and may be associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that depend upon that taxonomic group as a resource. In such cases, additional information on the biology of listed species, the locations of these species, and the- Page 48 of 68

- 

### locations of use sites are considered to determine the extent to which screening assumptions regarding an action area apply to a par ticular listed organism. These subsequent refinement steps will consider how this information would impact the action area for a particular listed organism and potentially include areas of exposure that are downwind and downstream of the pesticide use

sit e.

Assessment endpoints, exposure pathways, and the conceptual model s addressing proposed new ethaboxam uses, and the associated exposure and effects analyses conducted for ethaboxam

baseline risk assessment are in Sections 2 to 3 . The assessment endpoints used in the baseline risk assessment include those defined operationally as reduced survival and reproductive impairment for both aquatic and terrestrial animal species and survival, reproduction, and growth of aquatic and terre strial plant species from both direct acute and chronic exposures. These assessment endpoints are intended to address the standard set forth in the Endangered Species Act requiring federal agencies to ensure that any action they authorize does not appreci ably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species. Risk estimates (RQs) which, integrating exposure and effects, are calculated for broad base d taxonomic groups in the screening

- level risk assessment presented in Section 4.

Both acute endangered species and chronic risk LOCs are considered in the baseline risk assessment to identify direct and indirect effects to taxa of listed species. This s ection identifies direct effect concerns, by taxa that are triggered by exceeding endangered LOCs in the baseline risk assessment, with an evaluation of the potential probability of individual effects for exposures that may occur at the established endange red species LOC. Data on exposure and effects

collected under field and laboratory conditions are evaluated to make determinations on the predictive utility of the direct effect screening assessment findings to listed species. There were

no LOC exceedanc es for any assessed taxa.

Table 5.1. Potential Effects to Federally Listed Taxa Associated with Direct or Indirect Effects from the Proposed New Uses of Ethaboxam

.

Listed Taxon Direct Effects Indirect Effects a

Terrestrial and semi

- aquatic plants

- monocots No No

Terrestrial and semi

- aquatic plants

- dicots No No

Birds No No

Terrestrial

- phase amphibians and reptiles No No

Mammals No No Aquatic nonvascular plants No No

Aquatic vascular plants No No

Freshwater fish No No Aquatic

- phase amphibians No No

Freshwater invertebrates No No

Mollusks No No

Marine/estuarine fish No No

Marine/estuarine invertebrates No No

a direct effects are not expected for any taxa, therefore, indirect effects are not expected either.- Page 49 of 68

- 

### 5. 2 .1. Probit Dose

- Response Analysis

The Agency uses the probit dose

- response relationship as a tool for providing additional information on the potential for acute direct effects to aquatic and terrestrial animals (USEPA, 2004). As part of this evaluation, the acute RQ for listed species is presented in terms of the chance of an individual event ( i.e. , mortality or immobilization) should exposure at the EEC actually occur for a species with sensitivity to ethaboxam on par with the acute toxicity endpoint

selected for RQ calculation. To accomplish this interpretation, the Agency uses the slope of the

dose

- response relationship available from the toxicity study used to establish the acute toxicity measures of effect for each taxonomic group that is relevant to this ass essment. The individual effects probability associated with the acute RQ is based on the mean estimate of the slope and an assumption of a probit dose

- response relationship. In addition to a single effects probability estimate based on the mean, upper an d lower estimates of the effects probability are also provided to account for variance in the slope, if available. Based on the available acute toxicity

for ethaboxam , a summary of the probit dose

- response analysis is provided in Table 5.2 . If no

dose re sponse information is available to estimate a slope for this analysis, a default slope assumption of 4.5 (with lower and upper bounds of 2 to 9) (Urban and Cook, 1986) is used.

Individual effect probabilities are calculated based on an Excel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) developed by the U.S. EPA, OPP, Environmental Fate and Effects Division (June 22, 2004). The model allows for such calculations by entering the mean slope estimate (and the 95% confidence bounds of that estimate) as the slope parameter for the spreadsheet. The desired threshold for the probability of an individual effect is entered as the listed species LOC. In addition, the probability of an individual effect is also derived based

on the calculat ed acute RQ, if available.

Table 5.2. Summary of Ethaboxam Probit Dose Response Analysis for Listed Species

Taxa (study type) Acute Effect Slope (95% C.I.) Chance of Individual Effect at Listed Species LOC (95% C.I.) Chance of Individual

Effect at Derived Acute RQ 1,2 (95% C.I.)

Bird oral dose No mortality observed 1 in 2.9E+05 (1 in 44 to 1 in 8.86E+18) Not calculated; no mortality observed

Bird dietary No mortality observed 1 in 2.9E+05 (1 in 44 to 1 in 8.86E+18) Not calculated; no mortality observed

Mammal oral dose No mortality observed 1 in 4.3E+03 (1 in 2.21 to 1 in 3.57E+12) Not calculated; no mortality observed

Freshwater Fish Mortality Default Slope = 4.5 (2

– 9) 1 in 4.18E+08 (1 in 2.16E+02 to 1 in 1.75E+31) 1 in 6.12E+61 (1 in 1.45E+13 to 1 in

3.80E+242 ) 1

Freshwater invertebrates Mortality Default Slope = 4.5 (2

– 9) 1 in 4.18E+08 (1 in 2.16E+02 to 1 in 1.75E+31) 1 in 1.28E+41 (1 in 1.01E+09 to 1 in

1.35E+160 ) 2

1 Acute RQ for freshwater Fish = 0.0002

. 2 Acute RQ for freshwater invertebrates = 0.001

.



### As shown in Table 5.2 , t he probability for acute direct effects ( i.e. , mortality) to individual listed

fish or invertebrates is very low.- Page 50 of 68

- 

### 5. 2 .2. Listed Species Occurrence Asso ciated with Ethaboxam Use

T he goal of the co

- location analysis is to determine whether sites of pesticide use are geographically associated with known locations of listed species [following the convention of the Services, the word ‘species’ in this assessment may apply to a ‘spec ies’, ‘subspecies’, or an Evolutionary Significant Unit (ESU)]. At the screening level, this analysis is accomplished using the LOCATES database (version 2.10.3). The database uses location information for listed species at the county level and compares it to agricultural census data (from 2002) for crop production at the same county level of resolution. The product is a listing of Federally

- listed species that are located in counties known to produce the crops upon which the pesticide will be

used. Thi s analysis has not been conducted for this assessment.

6. References

Carousel, R.F., J.C. Imhoff, P.R. Hummel, J.M. Cheplick, A.S. Donigian, Jr., L.A. Suarez.

Undated. PRZM

- 3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.12.2. National Exposure Research Laboratory, Office of Research and Development, U.S. Environmental Protection Agency, Athens, GA; AQ UA TERRA Consultants, Mountain View, CA; Waterborne Environmental, Inc., Leesburg, VA.

Goring, C.A.I., D.A. Laskowki, J.H. Hamaker, and R.W. Meikle. 1975. Principles of pesticide degradation in soil. Pages 135

- 172 in (R. Haque and V.H. Freed, eds.) Enviro nmental dynamics of pesticides . Plenum Press, New York.

USEPA 1998. Guidelines for Ecological Risk Assessment. EPA/630/R

- 95/002F. Published in 63 FR 26846; May 14, 1998. U.S. Environmental Protection Agency, Washington, DC. April, 1998.

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency. Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D.C. January 23, 2004. Online at: http://www.epa.gov/oppfead1/endanger/consultation/ecorisk

- overview.pdf

USEPA 2006a. Standardized Soil Mobility Classification Guidance. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division, Memorandum. Apr. 21,

2006.

USEPA. 2006b. User’s Gu ide: TerrPlant Version 1.2.2 (Terrestrial Residue Exposure model). United States Environmental Protection Agency. Environmental Fate and Effects- Page 51 of 68

- 

### Division. Office of Pesticide Programs. U.S. Environmental protection Agency. Washington, D.C. December 26 , 2006.

USEPA 2008 . White Paper on Methods for Assessing Ecological Risks of Pesticides with Persistent, Bioaccumulative and Toxic Characteristics. Submitted to the FIFRA Scientific Advisory Panel. October 28

- 31, 2008. Office of Pesticide Programs, Enviro nmental Fate and Effects Division, Washington, D.C.

USEPA 2009 . Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division, Oct. 22, 2009. Online at: http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm

USEPA. 2011 b . Water Models. U.S. Environmental Protection Agency, Pesticides: Science and Policy, Models and Databases. Last updated Aug. 8, 2011. Online at: http://www.epa.gov/oppefed1/models/water/

USEPA. 2011 c

. DRAFT: Registration Review: Problem Formulation for the Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Exposur e Assessments of Clothianidin " 

### DP barcode 391491.

USDA. 2000. USDA Crop Profiles. Hosted by the Integrated Pest Management Centers.

Available online at: http://www.ipmcenters.org/cropprofiles/index.cfm

.

USFWS/NMFS. 2004. 50 CFR Part 402. Joint Counterpart Endangered Species Act Section 7 Consultation Regulations; Final Rule. FR 47732

- 47762.

Urban, D.J. and N.J. Cook, 1986. Hazard Evaluation Divisio n Standard Evaluation Procedure Ecological Risk Assessment. EPA 540/9

- 85

- 001. U.S. Environmental Protection Agency, Office of Pesticide Programs, Washington D.C.

6.1. Submitted Environmental Fate and Transport Studies

6.2. Submitted Ecotoxicity Studies- Page 52 of 68

- 

### Appendix A. Summary of Environmental Fate Data 1- Page 53 of 68

- 

### Appendix B . Aquatic Model Input/Output Data. 2

3 Example Input/Output Data for Individual Simulations 4

5 PRZM/EXAMS Example Input/Output File. 6

7
stored as MSsoybean.out 

### 8

Chemical: ethabox am 

### 9
PRZM environment: MSsoybeanSTD.txt modified Tueday, 29 May 2007 at 13:58:06 

### 10
EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06:14:08 

### 11

Metfile: w03940.dvf modified Tueday, 26 August 2008 at 06:14:14 

### 12
Water segment concentrations (ppb) 

### 13
14

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 

### 15

1961 0.4608 0.4416 0.4089 0.3538 0.3273 0.172 

### 16

1962 0.4704 0.4534 0.3793 0.3127 0.2897 0.1903 

### 17

1963 0.2349 0.2284 0.205 0.1871 0.1872 0.1626 

### 18

1964 0.4015 0.38 0.3311 0.2968 0.2773 0.1689 

### 19

1965 0.2539 0.2483 0.2324 0. 2076 0.1951 0.1288 

### 20

1966 0.2132 0.2087 0.1902 0.1767 0.1692 0.1151 

### 21

1967 0.3236 0.3099 0.269 0.2278 0.2128 0.1523 

### 22

1968 0.3345 0.3252 0.2896 0.2599 0.2423 0.1733 

### 23

1969 0.4377 0.4201 0.3637 0.3212 0.3032 0.2212 

### 24

1970 0.371 0.3646 0.3322 0.3097 0.2959 0.2033 

### 25

1971 0.315 0.3047 0.289 0.2541 0.2405 0.1651 

### 26

1972 0.1746 0.1712 0.1681 0.1528 0.1457 0.1135 

### 27

1973 0.4506 0.4363 0.3682 0.3162 0.2969 0.1908 

### 28

1974 0.3969 0.3799 0.3337 0.2861 0.2652 0.1726 

### 29

1975 0.2053 0.2009 0.1902 0.1704 0.1605 0.1046 

### 30

1976 0.44 0.4148 0.3771 0.3 33 0.3059 0.1814 

### 31

1977 0.3975 0.381 0.3383 0.2925 0.2737 0.1834 

### 32

1978 0.2161 0.2105 0.2015 0.1783 0.1702 0.1305 

### 33

1979 0.6651 0.6088 0.4495 0.3302 0.2881 0.1334 

### 34

1980 0.5456 0.512 0.4709 0.3743 0.321 0.1867 

### 35

1981 0.2224 0.2181 0.2093 0.1917 0.1883 0.1467 

### 36

1982 0. 3476 0.3362 0.3083 0.2731 0.2634 0.1552 

### 37

1983 0.5707 0.5339 0.4417 0.2894 0.2484 0.1394 

### 38

1984 0.1695 0.166 0.1545 0.1411 0.1359 0.09931 

### 39

1985 0.08929 0.08839 0.08607 0.08371 0.08152 0.06383 

### 40

1986 0.2519 0.2447 0.2197 0.189 0.1893 0.1296 

### 41

1987 0.3459 0.3348 0.3082 0.2746 0.2577 0.1728 

### 42

1988 0.4375 0.4228 0.3739 0.3302 0.3095 0.2132 

### 43

1989 0.2976 0.2891 0.266 0.2398 0.2301 0.1659 

### 44

1990 0.192 0.1868 0.1708 0.1549 0.1467 0.1061 

### 45 46

Sorted results 

### 47

Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 

### 48

0.032258064516129 0.6651 0.6 088 0.4709 0.3743 0.3273 0.2212 

### 49

0.0645161290322581 0.5707 0.5339 0.4495 0.3538 0.321 0.2132 

### 50

0.0967741935483871 0.5456 0.512 0.4417 0.333 0.3095 0.2033 

### 51

0.129032258064516 0.4704 0.4534 0.4089 0.3302 0.3059 0.1908 

### 52

0.161290322580645 0.4608 0.4416 0.3793 0.3302 0.3032 0.1903 

### 53

0.193548387096774 0.4506 0.4363 0.3771 0.3212 0.2969 0.1867 

### 54

0.225806451612903 0.44 0.4228 0.3739 0.3162 0.2959 0.1834 

### 55- Page 54 of 68

- 0.258064516129032 0.4377 0.4201 0.3682 0.3127 0.2897 0.1814 

### 56

0.290322580645161 0.4375 0.4148 0.3637 0.3097 0.2881 0.1733 

### 57

0.3 2258064516129 0.4015 0.381 0.3383 0.2968 0.2773 0.1728 

### 58

0.354838709677419 0.3975 0.38 0.3337 0.2925 0.2737 0.1726 

### 59

0.387096774193548 0.3969 0.3799 0.3322 0.2894 0.2652 0.172 

### 60

0.419354838709677 0.371 0.3646 0.3311 0.2861 0.2634 0.1689 

### 61

0.451612903225806 0.3476 0.3362 0.3083 0.2746 0.2577 0.1659 

### 62

0.483870967741936 0.3459 0.3348 0.3082 0.2731 0.2484 0.1651 

### 63

0.516129032258065 0.3345 0.3252 0.2896 0.2599 0.2423 0.1626 

### 64

0.548387096774194 0.3236 0.3099 0.289 0.2541 0.2405 0.1552 

### 65

0.580645161290323 0.315 0.3047 0.269 0.239 8 0.2301 0.1523 

### 66

0.612903225806452 0.2976 0.2891 0.266 0.2278 0.2128 0.1467 

### 67

0.645161290322581 0.2539 0.2483 0.2324 0.2076 0.1951 0.1394 

### 68

0.67741935483871 0.2519 0.2447 0.2197 0.1917 0.1893 0.1334 

### 69

0.709677419354839 0.2349 0.2284 0.2093 0.189 0.1883 0.1305 

### 70

0.741935483870968 0.2224 0.2181 0.205 0.1871 0.1872 0.1296 

### 71

0.774193548387097 0.2161 0.2105 0.2015 0.1783 0.1702 0.1288 

### 72

0.806451612903226 0.2132 0.2087 0.1902 0.1767 0.1692 0.1151 

### 73

0.838709677419355 0.2053 0.2009 0.1902 0.1704 0.1605 0.1135 

### 74

0.870967741935484 0.192 0.1868 0.1708 0.1549 0.1467 0.1061 

### 75

0.903225806451613 0.1746 0.1712 0.1681 0.1528 0.1457 0.1046 

### 76

0.935483870967742 0.1695 0.166 0.1545 0.1411 0.1359 0.09931 

### 77

0.967741935483871 0.08929 0.08839 0.08607 0.08371 0.08152 0.06383 

### 78 79

0.1 0.53808 0.50614 0.43842 0.33272 0.30914 0.20205 

### 80
Average of yearly averages: 0.154728 

### 81 82
Inputs generated by pe5.pl

- Novemeber 2006 

### 83 84

Data used for this run: 

### 85
Output File: MSsoybean 

### 86

Metfile: w03940.dvf 

### 87

PRZM scenario: MSsoybeanSTD.txt 

### 88

EXAMS environment file: pond298.exv 

### 89

Chemical Name: ethaboxam 

### 90
Description Variable Name Value Units Comments 

### 91
Molecular weight mwt 320.43 g/mol 

### 92
Henry's Law Const. henry 3.8E

- 8 atm

- m^3/mol 

### 93
Vapor Pressure vapr 6.1E

- 7 torr 

### 94
Solubility sol 5.2 mg/L 

### 95

Kd Kd mg/L 

### 96

Koc Koc 696 mg/L 

### 97
Photolysis half

- life kdp 0 days Half

- life 

### 98
Aerobic Aquatic Metabolism kbacw 373 days Halfife 

### 99
Anaerobic Aquatic Metabolism kbacs 3861 days Halfife 

### 100

Aerobic Soil Metabolism asm 119 days Halfife 

### 101
Hydrolysis: pH 7 0 days Half

- life 

### 102

Method: CAM 4 integer See PRZM manual 

### 103
Incorporation Depth: DEPI 5 cm 

### 104
Application Rate: TAPP 0.0695 kg/ha 

### 105
Application Efficiency: APPEFF 1.0 fraction 

### 106
Spray Drift DRFT 0.0 fraction of application rate applied to pond 

### 107
Application Date Date 16

- 3 dd/mm or dd/mmm or dd

- mm or dd

- mmm 

### 108

Record 17: FILTRA 

### 109

IPSCND 1 

### 110

UPTKF 

### 111- Page 55 of 68

- R ecord 18: PLVKRT 

### 112

PLDKRT 

### 113

FEXTRC 0.5 

### 114
Flag for Index Res. Run IR EPA Pond 

### 115

Flag for runoff calc. RUNOFF none, monthly or total(average of entire run) 

### 116- Page 56 of 68

- 

### Appendix C . Model Outputs 117

118

119

T

- REX Model Outputs 120

Animal Size Crop Maximu

m Applicati

on Rate Maximum

Seed Applicatio

n Rate Avian Nagy Dose Mammalia n Nagy

Dose Availa

ble AI

(lbs ai/A) (mg ai/kg seed) (mg ai/kg

bw/day) (mg ai/kg

bw/day) (mg ai

ft

- 2)

Small pea, garden 0.05 133.54 33.80 28.29 0.57

Medium 19.27 19.55

Large 8.63 4.53

Crop Risk Quotients†

Avian (20 g) Mammalian (15 g)

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c pea, garden 0.02 0.02 0.79 0.00 0.00 0.79

Avian (100 g) Mammalian (35 g)

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c pea, garden 0.01 0.00 0.79 0.00 0.00 0.68

Avian (1000 g) Mammalian (1000 g)

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c pea, garden 0.00 0.00 0.79 0.00 0.00 0.36



### 121

122

Animal Size Crop Maximu

m Applicati

on Rate Maximum

Seed Applicatio

n Rate Avian Nagy Dose Mammalia n Nagy

Dose Availa

ble AI

(lbs ai/A) (mg ai/kg seed) (mg ai/kg

bw/day) (mg ai/kg

bw/day) (mg ai

ft

- 2)

Small canola 0.00 66.77 16.90 14.15 0.02

Medium 9.64 9.78

Large 4.31 2.27- Page 57 of 68

- Crop Risk Quotients†

Avian (20 g) Mammalian (15 g)

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c
canola 0.01 0.00 0.39 0.00 0.00 0.40

Avian (100 g) Mammalian (35 g)

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c
canola 0.01 0.00 0.39 0.00 0.00 0.34

Avian (1000 g) Mammalian (1000 g)

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c
canola 0.00 0.00 0.39 0.00 0.00 0.18



### 123

Animal Size Crop Maximu

m Applicati

on Rate Maximum

Seed Applicatio

n Rate Avian Nagy Dose Mammalia n Nagy

Dose Availa

ble AI

(lbs ai/A) (mg ai/kg seed) (mg ai/kg

bw/day) (mg ai/kg

bw/day) (mg ai

ft

- 2)

Small wheat, all or unspecified 0.01 57.87 14.65 12.26 0.09

Medium 8.35 8.47

Large 3.74 1.96

Crop Risk Quotients†

Avian (20 g) Mammalian (15 g)

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c wheat, all or unspecified 0.01 0.00 0.34 0.00 0.00 0.34

Avian (100 g) Mammalian (35 g)

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c wheat, all or unspecified 0.00 0.00 0.34 0.00 0.00 0.29

Avian (1000 g) Mammalian (1000 g)- Page 58 of 68

- Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chroni

c wheat, all or unspecified 0.00 0.00 0.34 0.00 0.00 0.16



### 124 125 126 127 128- Page 59 of 68

- 

### 129

Appendix D Ethaboxam and Degradate ECOSAR Estimates 130

131
ECOSAR Version 1.11 Results Page 

### 132 133
SMILES : CCNc1nc(CC)c(s1)C(=O)NC(C(#N))c2cccs2 

### 134

CHEM : 

### 135

CAS Num: 

### 136

ChemID1: 

### 137

MOL FOR: C14 H16 N4 O1 S2 

### 138

MOL WT : 320.43 

### 139
Log Kow: 3.092 (EPISuite Kowwin v1.68 Estimate) 

### 140
Log Kow: 2.890 (User Entered) 

### 141
Log Kow: (PhysProp DB exp value

- for comparison only) 

### 142
Melt Pt: 185.00 (deg C, User Entered for Wat Sol estimate) 

### 143
Melt Pt: (deg C, Phy sProp DB exp value for Wat Sol estimate) 

### 144
Wat Sol: 3.839 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 145
Wat Sol: 12.4 (mg/L, User Entered) 

### 146
Wat Sol: (PhysProp DB exp value) 

### 147 148 149

-------------------------------------- 

### 150

Values used to Generate EC OSAR Profile 

### 151

-------------------------------------- 

### 152
Log Kow: 2.890 (User Entered) 

### 153
Wat Sol: 12.4 (mg/L, User Entered) 

### 154 155 156 157

-------------------------------------- 

### 158

ECOSAR v1.11 Class

- specific Estimations 

### 159

-------------------------------------- 

### 160
Thioph enes 

### 161

Amides 

### 162
Benzyl Nitriles 

### 163

Predicted 

### 164
ECOSAR Class Organism Duration End Pt mg/L (ppm) 

### 165

=========================== ================== ======== ====== ========== 

### 166
Thiophenes : Fish 96

- hr LC50 13.311 * 

### 167
Thiophenes : Daphnid 48

- hr LC50 9.199 

### 168
Thiophenes : Green Algae 96

- hr EC50 15.135 * 

### 169
Thiophenes : Fish ChV 1.014 ! 

### 170
Thiophenes : Daphnid ChV 0.938 ! 

### 171
Thiophenes : Green Algae ChV 13.217 * 

### 172 173

Amides : Fish 96

- hr LC50 22.110 * 

### 174
Amides : Daphnid 48

- hr LC50 16.155 * 

### 175
Amides : Green Algae 96

- hr EC50 0.843 

### 176

Amides : Fish ChV 0.064 

### 177
Amides : Daphnid ChV 1.631 

### 178
Amides : Green Algae ChV 1.152 

### 179

Amides : Fish (SW) 96

- hr LC50 19.7 07 * 

### 180
Amides : Mysid (SW) 96

- hr LC50 1.650 

### 181 182
Benzyl Nitriles : Fish 96

- hr LC50 6.939 

### 183
Benzyl Nitriles : Daphnid 48

- hr LC50 47.128 * 

### 184
Benzyl Nitriles : Green Algae 96

- hr EC50 1.775 

### 185
Benzyl Nitriles : Fish ChV 0.957 

### 186
Benzyl Nitriles : Daphnid ChV 0.650 

### 187
Benzyl Nitriles : Green Algae ChV 1.140 

### 188- Page 60 of 68

- Benzyl Nitriles : Fish (SW) 96

- hr LC50 11.179 

### 189
Benzyl Nitriles : Mysid (SW) 96

- hr LC50 0.804 

### 190 191

=========================== ================== ======== ====== ========== 

### 192
Neutral Organic SAR : Fish 96

- hr LC50 41.785 * 

### 193
(Baseline Toxicity) : Daphnid 48

- hr LC50 25.758 * 

### 194
: Green Algae 96

- hr EC50 26.951 * 

### 195

: Fish ChV 4.500 

### 196
: Daphnid ChV 3.157 

### 197
: Green Algae ChV 8.475 

### 198 199
Note: * = asterisk designate s: Chemical may not be soluble enough to 

### 200
measure this predicted effect. If the effect level exceeds the 

### 201
water solubility by 10X, typically no effects at saturation (NES) 

### 202

are reported. 

### 203 204
NOTE: ! = exclamation designates: The toxici ty value was estimated through 

### 205
application of acute

- to

- chronic ratios per methods outlined in 

### 206
the ECOSAR Methodology Document provided in the ECOSAR Help Menu. 

### 207 208 209

------------------------------ 

### 210
Class Specific LogKow Cut

- Offs 

### 211

------------------------------ 

### 212
If the log Kow of the chemical is greater than the endpoint specific cut

- offs 

### 213
presented below, then no effects at saturation are expected for those endpoints. 

### 214 215
Thiophenes: 

### 216

---------- 

### 217
Maximum LogKow: 5.0 (LC50) 

### 218
Maximum LogKow : 6.4 (EC50) 

### 219
Maximum LogKow: 8.0 (ChV) 

### 220 221

Amides : 

### 222

------- 

### 223
Maximum LogKow: >8.5 (LC50) 

### 224
Maximum LogKow: >8.0 (EC50,ChV) 

### 225 226
Benzyl Nitriles : 

### 227

---------------- 

### 228
Maximum LogKow: 5.0 (LC50) 

### 229
Maximum LogKow: 6.4 (Green Algae EC50) 

### 230
Maximum LogKow: 8.0 (Chronic Values) 

### 231 232
Baseline Toxicity SAR Limitations: 

### 233

--------------------------------- 

### 234
Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) 

### 235
Maximum LogKow: 6.4 (Green Algae EC50) 

### 236
Maximum LogKow: 8.0 (ChV) 

### 237 238 239 240

-------------------------------------------------------- ---------------------- 

### 241 242
ECOSAR Version 1.11 Results Page 

### 243 244

SMILES : CCNc1nc(CC)c(s1)C(=O)N 

### 245

CHEM : LGC

- 32523 

### 246

CAS Num: 

### 247

ChemID1: 

### 248

MOL FOR: C8 H13 N3 O1 S1 

### 249

MOL WT : 199.27 

### 250- Page 61 of 68

- Log Kow: 1.648 (EPISuite Kowwin v1.68 Estimate) 

### 251
Log Kow: (User Entered) 

### 252
Log Kow: (PhysProp DB exp value

- for comparison only) 

### 253

Melt Pt: (User Entered for Wat Sol estimate) 

### 254
Melt Pt: (deg C, PhysProp DB exp value for Wat Sol estimate) 

### 255
Wat Sol: 1728 (mg/L, EPISuite WSKowwin v1.43 Es timate) 

### 256

Wat Sol: (User Entered) 

### 257
Wat Sol: (PhysProp DB exp value) 

### 258 259 260

-------------------------------------- 

### 261

Values used to Generate ECOSAR Profile 

### 262

-------------------------------------- 

### 263
Log Kow: 1.648 (EPISuite Kowwin v1.68 Estimate) 

### 264
Wat Sol: 1728 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 265 266 267 268

-------------------------------------- 

### 269

ECOSAR v1.11 Class

- specific Estimations 

### 270

-------------------------------------- 

### 271

Amides 

### 272

Predicted 

### 273
ECOSAR Class Organism Duration End Pt mg/L (ppm) 

### 274

=========================== ================== ======== ====== ========== 

### 275

Amides : Fish 96

- hr LC50 106.300 

### 276
Amides : Daphnid 48

- hr LC50 137.654 

### 277
Amides : Green Algae 96

- hr EC50 3.098 

### 278

Amides : Fish ChV 0.148 

### 279

Amides : Daphnid ChV 6.120 

### 280
Amides : Green Algae ChV 2.509 

### 281

Amides : Fish (SW) 96

- hr LC50 93.559 

### 282
Amides : Mysid (SW) 96

- hr LC50 5.295 

### 283 284

=========================== ================== ======== ====== ========== 

### 285
Neutral Organic SAR : Fish 96

- hr LC50 339.053 

### 286
(Baseline Toxicity) : Daphnid 48

- hr LC50 186.358 

### 287
: Green Algae 96

- hr EC50 121.359 

### 288

: Fish ChV 31.894 

### 289
: Daphnid ChV 16.602 

### 290
: Green Algae ChV 29.562 

### 291 292
Note: * = asterisk designates: Chemical may not be soluble enough to 

### 293
measure this predicted effect. If the effect level exceeds the 

### 294
water solubility by 10X, typically no ef fects at saturation (NES) 

### 295

are reported. 

### 296 297 298

------------------------------ 

### 299
Class Specific LogKow Cut

- Offs 

### 300

------------------------------ 

### 301
If the log Kow of the chemical is greater than the endpoint specific cut

- offs 

### 302
presented below, then no effects at saturation are expected for those endpoints. 

### 303 304

Amides : 

### 305

------- 

### 306
Maximum LogKow: >8.5 (LC50) 

### 307
Maximum LogKow: >8.0 (EC50,ChV) 

### 308 309
Baseline Toxicity SAR Limitations: 

### 310

--------------------------------- 

### 311
Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) 

### 312- Page 62 of 68

- Maximum LogKow: 6.4 (Green Algae EC50) 

### 313
Maximum LogKow: 8.0 (ChV) 

### 314 315 316 317

------------------------------------------------------------------------------ 

### 318 319
ECOSAR Version 1.11 Results Page 

### 320 321

SMILES : CCNc1nc(CC)c(s1)C(=O)NC(C(=O)N)c2cccs2 

### 322

CHEM : LGC

- 32525 

### 323

CAS N um: 

### 324

ChemID1: 

### 325

MOL FOR: C14 H18 N4 O2 S2 

### 326

MOL WT : 338.44 

### 327
Log Kow: 2.324 (EPISuite Kowwin v1.68 Estimate) 

### 328
Log Kow: (User Entered) 

### 329
Log Kow: (PhysProp DB exp value

- for comparison only) 

### 330

Melt Pt: (User Entered for Wat So l estimate) 

### 331
Melt Pt: (deg C, PhysProp DB exp value for Wat Sol estimate) 

### 332
Wat Sol: 75.36 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 333

Wat Sol: (User Entered) 

### 334
Wat Sol: (PhysProp DB exp value) 

### 335 336 337

-------------------------------------- 

### 338

Values used to Generate ECOSAR Profile 

### 339

-------------------------------------- 

### 340
Log Kow: 2.324 (EPISuite Kowwin v1.68 Estimate) 

### 341
Wat Sol: 75.36 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 342 343 344 345

--------------------- ----------------- 

### 346

ECOSAR v1.11 Class

- specific Estimations 

### 347

-------------------------------------- 

### 348
Thiophenes 

### 349

Amides 

### 350

Predicted 

### 351
ECOSAR Class Organism Duration End Pt mg/L (ppm) 

### 352

=========================== ================== ======== ====== ========== 

### 353
Thiophenes : Fish 96

- hr LC50 34.269 

### 354
Thiophenes : Daphnid 48

- hr LC50 22.631 

### 355
Thiophenes : Green Algae 96

- hr EC50 42.692 

### 356
Thiophenes : Fish ChV 2.753 ! 

### 357
Thiophenes : Daphnid ChV 2.291 ! 

### 358
Thiophenes : Green Algae ChV 32.203 

### 359 360

Amides : Fish 96

- hr LC50 59.335 

### 361
Amides : Daphnid 48

- hr LC50 56.278 

### 362
Amides : Green Algae 96

- hr EC50 2.001 

### 363

Amides : Fish ChV 0.123 

### 364
Amides : Daphnid ChV 3.909 

### 365
Amides : Green Algae ChV 2.154 

### 366

Amides : Fish (SW) 96

- hr LC50 52.582 

### 367
Amides : Mysid (SW) 96

- hr LC50 3.683 

### 368 369

=========================== ================== ======== ====== ========== 

### 370
Neutral Organic SAR : Fish 96

- hr LC50 142.355 * 

### 371
(Baseline Toxicity) : Daphnid 48

- hr LC50 83.282 * 

### 372
: Green Algae 96

- hr EC50 70.198 

### 373

: Fish ChV 14.414 

### 374- Page 63 of 68

- : Daphnid ChV 8.826 

### 375
: Green Algae ChV 19.648 

### 376 377
Note: * = asterisk designates: Chemical may not be soluble enough to 

### 378
measure this predicted effect. If the effect level exceeds the 

### 379
water solubility by 10X, typically no effects at saturation (NES) 

### 380

are reported. 

### 381 382
NOTE: ! = exclamation designates: The toxicity value was estimated through 

### 383
application of acute

- to

- chronic ratios per methods outlined in 

### 384
the ECOSAR Methodology Document provided in the ECOSAR Help Menu. 

### 385 386 387

------------------------------ 

### 388
Class Specific LogKow Cut

- Offs 

### 389

------------------------------ 

### 390

If the log Kow of the chemical is greater than the endpoint specific cut

- offs 

### 391
presented below, then no effects at saturation are expected for those endpoints. 

### 392 393
Thiophenes: 

### 394

---------- 

### 395
Maximum LogKow: 5.0 (LC50) 

### 396
Maximum LogKow: 6.4 (EC50) 

### 397
Maximum LogKow: 8.0 ( ChV) 

### 398 399

Amides : 

### 400

------- 

### 401
Maximum LogKow: >8.5 (LC50) 

### 402
Maximum LogKow: >8.0 (EC50,ChV) 

### 403 404
Baseline Toxicity SAR Limitations: 

### 405

--------------------------------- 

### 406
Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) 

### 407
Maximum LogKow: 6.4 (Green Algae EC50) 

### 408

Maximum LogKow: 8.0 (ChV) 

### 409 410 411
ECOSAR Version 1.11 Results Page 

### 412 413

SMILES : CCNc1nc(CC)c(s1)C(=O)NC(=O)c2cccs2 

### 414

CHEM : LGC

- 32533 

### 415

CAS Num: 

### 416

ChemID1: 

### 417

MOL FOR: C13 H15 N3 O2 S2 

### 418

MOL WT : 309.40 

### 419
Log Kow: 1.986 (EPISuite Kowwin v1.68 Estimate) 

### 420

Log Kow: (User Entered) 

### 421
Log Kow: (PhysProp DB exp value

- for comparison only) 

### 422

Melt Pt: (User Entered for Wat Sol estimate) 

### 423
Melt Pt: (deg C, PhysProp DB exp value for Wat Sol estimate) 

### 424
Wat Sol: 218 (mg/L, EPISuite WSKowwin v1 .43 Estimate) 

### 425

Wat Sol: (User Entered) 

### 426
Wat Sol: (PhysProp DB exp value) 

### 427 428 429

-------------------------------------- 

### 430

Values used to Generate ECOSAR Profile 

### 431

-------------------------------------- 

### 432
Log Kow: 1.986 (EPISuite Kowwin v1.68 Estimate) 

### 433
Wat Sol: 218 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 434 435 436- Page 64 of 68

- 

### 437

-------------------------------------- 

### 438

ECOSAR v1.11 Class

- specific Estimations 

### 439

-------------------------------------- 

### 440

Imides 

### 441
Thiophenes 

### 442

Predicted 

### 443
ECOSAR Class Organism Duration End Pt mg/L (ppm) 

### 444

=========================== ================== ======== ====== ========== 

### 445

Imides : Fish 96

- hr LC50 16.880 

### 446
Imides : Daphnid 48

- hr LC50 18.621 

### 447
Imides : Green Algae 96

- hr EC50 0.090 

### 448

Imides : Fish ChV 3.483 

### 449

Imides : Daphnid ChV 5.520 

### 450
Imides : Green Algae ChV 0.015 

### 451
Imides : Mysid 96

- hr LC50 23.075 

### 452 453
Thiophenes : Fish 96

- hr LC50 53.329 

### 454
Thiophenes : Daphnid 48

- hr LC50 34.274 

### 455
Thiophenes : Green Algae 96

- hr EC50 70.157 

### 456
Thiophenes : Fish Ch V 4.423 ! 

### 457
Thiophenes : Daphnid ChV 3.455 ! 

### 458
Thiophenes : Green Algae ChV 48.490 

### 459 460

=========================== ================== ======== ====== ========== 

### 461

Ne utral Organic SAR : Fish 96

- hr LC50 261.853 * 

### 462
(Baseline Toxicity) : Daphnid 48

- hr LC50 148.484 

### 463
: Green Algae 96

- hr EC50 110.000 

### 464

: Fish ChV 25.555 

### 465
: Daphnid ChV 14.427 

### 466
: Green Algae ChV 28.721 

### 467 468
Note: * = asterisk designates: Chemical may not be soluble enough to 

### 469
measure this predicted effect. If the effect level exceeds the 

### 470
water solubility by 10X, typically no effects at saturation (NES) 

### 471

are reported. 

### 472 473

NOTE: ! = exclamation designates: The toxicity value was estimated through 

### 474
application of acute

- to

- chronic ratios per methods outlined in 

### 475
the ECOSAR Methodology Document provided in the ECOSAR Help Menu. 

### 476 477 478

------------------------------ 

### 479
Class Specific LogKow Cut

- Offs 

### 480

------------------------------ 

### 481
If the log Kow of the chemical is greater than the endpoint specific cut

- offs 

### 482
presented below, then no effects at saturation are expected for those endpoints. 

### 483 484

Imides: 

### 485

------ 

### 486
Maximum LogKow: 5. 0 (LC50) 

### 487
Maximum LogKow: 6.4 (EC50) 

### 488
Maximum LogKow: 8.0 (ChV) 

### 489 490
Thiophenes: 

### 491

---------- 

### 492
Maximum LogKow: 5.0 (LC50) 

### 493
Maximum LogKow: 6.4 (EC50) 

### 494
Maximum LogKow: 8.0 (ChV) 

### 495 496
Baseline Toxicity SAR Limitations: 

### 497

--------------------------------- 

### 498- Page 65 of 68

- Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) 

### 499
Maximum LogKow: 6.4 (Green Algae EC50) 

### 500
Maximum LogKow: 8.0 (ChV) 

### 501 502 503 504

------------------------------------------------------------------------------ 

### 505 506
ECOSAR Version 1.11 Results Page 

### 507 508

SMILES : CCNc1nc(CC)c(s1)C(=O)N=C(C(#N))c2cccs2 

### 509

CHEM : LGC

- 32799 

### 510

CAS Num: 

### 511

ChemID1: 

### 512

MOL FOR: C14 H14 N4 O1 S2 

### 513

MOL WT : 318.41 

### 514
Log Kow: 4.648 (EPISuite Kowwin v1.68 Estimate) 

### 515
Log Kow: (User Entered) 

### 516
Log Kow: (PhysProp DB exp value

- f or comparison only) 

### 517

Melt Pt: (User Entered for Wat Sol estimate) 

### 518
Melt Pt: (deg C, PhysProp DB exp value for Wat Sol estimate) 

### 519
Wat Sol: 1.027 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 520

Wat Sol: (User Entered) 

### 521

Wat Sol: (PhysProp DB exp value) 

### 522 523 524

-------------------------------------- 

### 525

Values used to Generate ECOSAR Profile 

### 526

-------------------------------------- 

### 527
Log Kow: 4.648 (EPISuite Kowwin v1.68 Estimate) 

### 528
Wat Sol: 1.027 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 529 530 531 532

-------------------------------------- 

### 533

ECOSAR v1.11 Class

- specific Estimations 

### 534

-------------------------------------- 

### 535
Thiophenes 

### 536

Amides 

### 537

Predicted 

### 538

ECOSAR Class Organism Duration End Pt mg/L (ppm) 

### 539

=========================== ================== ======== ====== ========== 

### 540
Thiophenes : Fish 96

- hr LC50 0.832 

### 541
Thiophenes : Daphnid 48

- hr LC50 0.663 

### 542
Thiophenes : Green Algae 96

- hr EC50 0.713 

### 543
Thiophenes : Fish ChV 0.054 ! 

### 544
Thiophenes : Daphnid ChV 0.069 ! 

### 545
Thiophenes : Green Algae ChV 0.981 

### 546 547

Amides : Fish 96

- hr LC50 1.216 * 

### 548
Amides : Daphnid 48

- hr LC50 0.395 

### 549

Amides : Green Algae 96

- hr EC50 0.068 

### 550

Amides : Fish ChV 0.010 

### 551
Amides : Daphnid ChV 0.127 

### 552
Amides : Green Alg ae ChV 0.194 

### 553

Amides : Fish (SW) 96

- hr LC50 1.103 * 

### 554
Amides : Mysid (SW) 96

- hr LC50 0.161 

### 555 556

=========================== ================== ======== ====== ========== 

### 557
Neutral Organic SAR : Fish 96

- hr LC50 1.095 * 

### 558
(Baseline Toxicity) : Daphnid 48

- hr LC50 0.794 

### 559
: Green Algae 96

- hr EC50 1.626 * 

### 560- Page 66 of 68

- : Fish ChV 0.143 

### 561
: Daphnid ChV 0.153 

### 562
: Green Algae ChV 0.734 

### 563 564

Note: * = asterisk desi gnates: Chemical may not be soluble enough to 

### 565
measure this predicted effect. If the effect level exceeds the 

### 566
water solubility by 10X, typically no effects at saturation (NES) 

### 567

are reported. 

### 568 569
NOTE: ! = exclamation designates: The t oxicity value was estimated through 

### 570
application of acute

- to

- chronic ratios per methods outlined in 

### 571
the ECOSAR Methodology Document provided in the ECOSAR Help Menu. 

### 572 573 574

------------------------------ 

### 575
Class Specific LogKow Cut

- Offs 

### 576

- ----------------------------- 

### 577
If the log Kow of the chemical is greater than the endpoint specific cut

- offs 

### 578
presented below, then no effects at saturation are expected for those endpoints. 

### 579 580
Thiophenes: 

### 581

---------- 

### 582
Maximum LogKow: 5.0 (LC50) 

### 583
Maximum LogKow: 6.4 (EC50) 

### 584
Maximum LogKow: 8.0 (ChV) 

### 585 586

Amides : 

### 587

------- 

### 588
Maximum LogKow: >8.5 (LC50) 

### 589
Maximum LogKow: >8.0 (EC50,ChV) 

### 590 591
Baseline Toxicity SAR Limitations: 

### 592

--------------------------------- 

### 593
Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) 

### 594
Maximum LogKow: 6.4 (Green Algae EC50) 

### 595
Maximum LogKow: 8.0 (ChV) 

### 596 597 598 599

------------------------------------------------------------------------------ 

### 600 601
ECOSAR Version 1.11 Results Page 

### 602 603
SMILES : CCC(=O)NC(C(#N))c2cccs2 

### 604

CHEM : LGC 35525 

### 605

CAS Num: 

### 606

ChemID1: 

### 607

MOL FOR: C9 H10 N2 O1 S1 

### 608

MOL WT : 194.25 

### 609
Log Kow: 0.773 (EPISuite Kowwin v1.68 Estimate) 

### 610
Log Kow: (User Entered) 

### 611
Log Kow: (PhysProp DB exp value

- for comparison only) 

### 612

Melt Pt: (User Entered for Wat Sol estimate) 

### 613

Melt Pt: (deg C, PhysProp DB exp value for Wat Sol estimate) 

### 614
Wat Sol: 5559 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 615

Wat Sol: (User Entered) 

### 616
Wat Sol: (PhysProp DB exp value) 

### 617 618 619

-------------------------------------- 

### 620

Values used to Genera te ECOSAR Profile 

### 621

-------------------------------------- 

### 622- Page 67 of 68

- Log Kow: 0.773 (EPISuite Kowwin v1.68 Estimate) 

### 623
Wat Sol: 5559 (mg/L, EPISuite WSKowwin v1.43 Estimate) 

### 624 625 626 627

-------------------------------------- 

### 628

ECOSAR v1.11 Class

- specific Estimations 

### 629

-- ------------------------------------ 

### 630
Thiophenes 

### 631

Amides 

### 632
Benzyl Nitriles 

### 633

Predicted 

### 634
ECOSAR Class Organism Duration End Pt mg/L (ppm) 

### 635

=========================== ================== ======== ====== ========== 

### 636
Thiophenes : Fish 96

- hr LC50 225.584 

### 637
Thiophenes : Daphnid 48

- hr LC50 131.519 

### 638
Thiophenes : Green Algae 96

- hr EC50 360.820 

### 639
Thiophenes : Fish ChV 20.974 ! 

### 640
Thiophenes : Daphnid ChV 13.064 ! 

### 641
Thiophenes : Green Algae ChV 182.268 

### 642 643

Amides : Fish 96

- hr LC50 437.546 

### 644
Amides : Daphnid 48

- hr LC50 847.863 

### 645
Amides : Green Algae 96

- hr EC50 10.560 

### 646

Amides : Fish ChV 0.362 

### 647
Amides : Daphnid ChV 21.158 

### 648
Amides : Green Algae ChV 5.911 

### 649

Amides : Fish (SW) 96

- hr LC50 381.702 

### 650
Amides : Mysid (SW) 96

- hr LC50 16.392 

### 651 652
Benzyl Nitriles : Fish 96

- hr LC50 69.471 

### 653
Benzyl Nitriles : Daphnid 48

- hr LC50 3599.957 

### 654
Benzyl Nitriles : Green Algae 96

- hr EC50 11.693 

### 655
Benzyl Nitriles : Fish ChV 19.327 

### 656
Benzyl Nitriles : Daphnid ChV 7.790 

### 657
Benzyl Nitriles : Green Algae ChV 5.697 

### 658
Benzyl Nitriles : Fish (SW) 96

- hr LC50 117.509 

### 659
Benzyl Nitriles : Mysid (SW) 96

- hr LC50 3.745 

### 660 661

============ =============== ================== ======== ====== ========== 

### 662
Neutral Organic SAR : Fish 96

- hr LC50 2017.651 

### 663
(Baseline Toxicity) : Daphnid 48

- hr LC50 1022.933 

### 664

: Green Algae 96

- hr EC50 477.010 

### 665

: Fish ChV 172.549 

### 666
: Daphnid ChV 72.782 

### 667
: Green Algae ChV 97.066 

### 668 669
Note: * = asterisk designates: Chemical may not be soluble enough to 

### 670
measure this predicted effect. If the effect level exceeds the 

### 671
water solubility by 10X, typ ically no effects at saturation (NES) 

### 672

are reported. 

### 673 674
NOTE: ! = exclamation designates: The toxicity value was estimated through 

### 675
application of acute

- to

- chronic ratios per methods outlined in 

### 676
the ECOSAR Methodology Documen t provided in the ECOSAR Help Menu. 

### 677 678 679

------------------------------ 

### 680
Class Specific LogKow Cut

- Offs 

### 681

------------------------------ 

### 682
If the log Kow of the chemical is greater than the endpoint specific cut

- offs 

### 683

presented below, then no effects at saturation are expected for those endpoints. 

### 684- Page 68 of 68

- 

### 685
Thiophenes: 

### 686

---------- 

### 687
Maximum LogKow: 5.0 (LC50) 

### 688
Maximum LogKow: 6.4 (EC50) 

### 689
Maximum LogKow: 8.0 (ChV) 

### 690 691

Amides : 

### 692

------- 

### 693
Maximum LogKow: >8.5 (LC50) 

### 694
Maximum LogKow: >8.0 (EC50,ChV) 

### 695 696
Benzyl Nitriles : 

### 697

---------------- 

### 698
Maximum LogKow: 5.0 (LC50) 

### 699
Maximum LogKow: 6.4 (Green Algae EC50) 

### 700
Maximum LogKow: 8.0 (Chronic Values) 

### 701 702
Baseline Toxicity SAR Limitations: 

### 703

--------------------------------- 

### 704
Maximum LogKow: 5.0 (Fish 96

- hr LC50; Daphnid LC50) 

### 705
Maximum LogKow: 6.4 (Green Algae EC50) 

### 706
Maximum LogKow: 8.0 (ChV) 

### 707 708 709 710

------------------------------------------------------------------------------ 

### 711 712 713

------------------------------------------------------------------------------ 

### 714 715 716