### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C

., 20460

OFFICE OF CHE M ICAL SAFETY A N D POLLUTION PREVENTION



### PC C ode: 128111
DP B a r c od es: 41 7 2 72; 41 7 2 7 3 ; 4 1 7 2 74; 4 1 7 412 a nd 41 7 416
Dat e : Jul y 

### 1

, 201 5



## ME M ORA N D UM

SU B JEC T: Environmental Fate and Ecological Risk Assessment for the New Chemical Registration of Oxathiapiprolin for Propos ed Uses on Brassica. Leafy

, Bulb, Cucurbit, Fruit in g , and Tuberous / Corm Vegetables; Ginseng; Peas; Tobacco; Ornamentals; and Turf



### T O: Marce l Howard

, Risk Manager Reviewer Tony Kish. Risk Manager

, RM 22



### F RO M : Fungicide Branch, Registration Divi s ion (7505

## P)**~MJ U~::;·~O;::~=c~** **~~:::** 

# Ot/oJ j /5

Mohammed A. Ruhman

, Ph.D.

, Senior

# Agronomi~tpL<jl 

# F

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# 7 / o ( 

# I/ 

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THR U : 

### Justin Hou se nger. Biolo g ist

. Environmental Ri sk Branch 5
Environmental Fate and Effects Divi s ion (7507 P )

Mah Sham i m , Ph. D., Chief

, Environmental Risk Branch 5
Environmental Fate and Effec t s D i vis i on (7507 P)

Pl ease find attached the subje ct document. 

## 01/01/1£'

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



# Environmental Fate and Ecological Risk Assessment for the New

Chemical Registration of Oxa thiapiprolin for Proposed Uses on Brassica, Leafy, Bulb, Cucurbit, F r uiting, and T uberous /Corm

Vegetables; Ginseng; Peas; Tobacco; O rnamentals; and T urf

Chemical Formula: C 24 

# H 22 

# F 5 

# N 5 

# O 2 

# S PC Code: 128111 CAS Number: 1003318

- 67

- 9

Prepared by: Mohammed A. Ruhman, Senior Agronomist Justin Housenger, Biologist

Reviewed by: José Meléndez, Chemist Al Vaughan, Risk Assessment Process Leader United States Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division Environmental Risk Branch V 1200 Pennsylvania Ave. Mail Code 7507P Washington, D.C. 20460 

# N O S

N N

O N
N C H 3



# F F

F F

F

### 2 

## Table of Contents

I. Executive Summary

................................ ................................ ................................ ................................ ............... 6
II. Problem Formulation

................................ ................................ ................................ ................................ ....... 10 2.1. Nature of Regulatory Action

................................ ................................ ................................ ............................. 10 2.2. Nature of the Chemical Stressor

................................ ................................ ................................ ....................... 10 2.2.1. Overview of Pesticide Usage

................................ ................................ ................................ ..................... 10 2.2.2. Pesticide Type, Class, and Mode of Action

................................ ................................ ............................... 10 2.2.3. Overview of Physicochemical, Fate, and Transport Properties

................................ ................................ . 11 2.2.4. Stressor Source, Identity, and Intensity

................................ ................................ ................................ ..... 11 2.3. Ecological Receptors

................................ ................................ ................................ ................................ ........ 12 2.4. Ecosystems at Risk

................................ ................................ ................................ ................................ ........... 13 2.5. Assessment Endpoints

................................ ................................ ................................ ................................ ...... 13 2.6. Conceptual Model

................................ ................................ ................................ ................................ ............. 14 2.6.1. Diagram

................................ ................................ ................................ ................................ ..................... 14 2.6.2 Risk Hypothesis

................................ ................................ ................................ ................................ .......... 16 2.7. Analysis Plan

................................ ................................ ................................ ................................ .................... 17 2.7.1. Methods of Conducting Ecological Risk Assessment

................................ ................................ ............... 17 2.7.2 Measures of Aquatic Exposure

................................ ................................ ................................ .................. 17 2.7.3 Measures of Exposure

................................ ................................ ................................ ................................ 17 2.7.4. Measures of Effect

................................ ................................ ................................ ................................ ..... 19
III. Exposure Assessment

................................ ................................ ................................ ................................ ...... 21 3.1 Use characterization

................................ ................................ ................................ ................................ ........... 21 3.1. 1 Oxathiapiprolin Labels

................................ ................................ ................................ ............................... 21 3.1.2 Oxathiapiprolin Fungicide Characteristics

................................ ................................ ................................ . 21 3.1.3 Crop Use Patterns

................................ ................................ ................................ ................................ ....... 21 3.1.4 Application Procedures

................................ ................................ ................................ ............................... 22 3.1.5 Application Parameters for the Labelled Use Patterns

................................ ................................ ............... 23 3.2 Environmental Fate and Transport Characterization

................................ ................................ ......................... 24 3.2.1 Physical and Chemical Properties of oxathiapiprolin parent

................................ ................................ ...... 25 3.2.2 Hydrolysis, Aqueous photolysis and Photolysis on soil for oxathiapiprolin parent

................................ .... 25 3.2.3 Aerobic Soil Metabolism of oxathiapiprolin parent

................................ ................................ .................... 27 3.2.4 Aerobic/Anaerobic Metabolism in Water/Sediment Systems for oxathiapiprolin parent

........................... 31 3.2.4 Degradation Pathway for parent

................................ ................................ ................................ ................. 36 3.2.5 Field Studies: Terrestrial Field Dissipation of Parent Oxathiapiprolin

................................ ....................... 37 3.2.6 Environmental Chemistry Methods (ECMs) and Independent Laborator y Validation (ILVs)

............ 40 3.2.7 Environmental Mobility of Parent

................................ ................................ ................................ ............. 40 3.3. Oxathiapiprolin Transformation Products/Degradates (TPs/DEGs)

................................ ................................ . 41 3.3.1 Physical and Chemical Properties of the TPs/DEGs

................................ ................................ ................... 41 3.3.2 H ydrolysis, Aqueous photolysis and Photolysis on soil for the TPs/DEGs

................................ ................ 42 3.3.3 Aerobic Soil Metab olism; Aerobic/Anaerobic Metabolism in Water Sediment Systems and Terrestrial Field Studies for the TPs/DEGs

................................ ................................ ................................ ........................... 42 3.3.4 Environmental Mobility of TPs and DEGs

................................ ................................ ................................ . 46 3.4. Stressor of Concern

................................ ................................ ................................ ................................ ........... 48 3.4.1 Determination of the Stressor of Concern

................................ ................................ ................................ .. 48

3.4.1.1 Exposu re

................................ ................................ ................................ ................................ .............. 48 (1) Aerobic Soil System (90 th percentile t 1⁄2 = 161 days)

................................ ................................ ............ 50 3.4.1.2 Toxicity of TPs and DEGs of Oxathiapiprolin to Aquatic Taxa

................................ .......................... 52 3.4.1.3 Rationale for selection of the stressor of concern

................................ ................................ ................ 56 3.4.2 Aquatic Exposure Assessment

................................ ................................ ................................ ............. 59

3.4.2.1. Inputs Used for Modeling

................................ ................................ ................................ ............... 59 3.4.2.2. Modeling Results

................................ ................................ ................................ ............................ 61 3.4.3. Terrestrial Exposure Assessment

................................ ................................ ................................ ............... 62

### 3 3.4.3.1. Terrestrial Modeling for Birds and Mammals

................................ ................................ .................... 63 3.4.3.2. Non

- Target Plant Exposure Assessment

................................ ................................ ............................. 66 3.4.3.3. Tier I Exposure Estimates for Honey Bees

................................ ................................ ..................... 66 3.4.3.4. Terrestrial Organism Exposure in Residues on Aqua tic Food Items (KABAM)

................................ 67
IV. Ecological Effects Characterization

................................ ................................ ................................ ................. 69

4.1. Aquatic Effects

................................ ................................ ................................ ................................ .... 69 4.2. Ter restrial Effects

................................ ................................ ................................ ................................ 78
V. RISK CHARACTERIZATION

................................ ................................ ................................ ....................... 87 5.1. Risk Estimation

– Integration of Exposure and Effects Data

................................ ................................ ............ 87 5.1.1. Risks to Non

- Target Aquatic Animals

................................ ................................ ................................ ....... 88 5.2. Risk Description

– Interpretation of Direct Effects

................................ ................................ .......................... 98 5.3. Endocrine Effects

................................ ................................ ................................ ............................... 104 5.4. Threatened and Endangered Species Concerns

................................ ................................ .................. 105 5.4.1. Action Area

................................ ................................ ................................ ................................ ........ 106 5.4.2. T axonomic Groups Potentially at Risk

................................ ................................ .............................. 106
VI. Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps

................................ ...... 109
VII. REFERENCES

................................ ................................ ................................ ................................ .............. 114



## Appendice s Appendix A. Transformation Products (TP) and Degradates (DEGs) Observed in Environmental Fate Studies

.... 127 Appendix B. Output of STIR Results

................................ ................................ ................................ ....................... 143
A ppendix C. Output of SIP Results

................................ ................................ ................................ .......................... 144 Appendix D. Sample Output of T

- REX Results

................................ ................................ ................................ ....... 145 Appendix E. Sample Ouput of KABAM Results

................................ ................................ ................................ ...... 149



## Table of Figures

Figure 2.1 An ecological conceptual model for aquatic exposure from application of oxathiapiprolin (Note: Ingestion pathways should be solid lines)

................................ ................................ ................................ ................................ ... 15 Figure 2.2 An ecological conceptual model for terrestrial exposure from application of oxathiapiprolin

.................. 16 Figure 3.1 Degradation pathway, persistence and mobility of oxathiapiprolin in soils and aquatic systems as indicated from laboratory studies (refer to abbreviations below the table)

................................ ................................ .. 37 Figure 3.2 Processes and levels of transformation pr oducts/degradates of oxathiapiprolin in soil and aquatic systems

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



## Table of Tables

Table 2.1. Taxonomic groups and example test species for potential effects of oxathiapiprolin.

.............................. 12 Table 2.2. Summary of measures of exposur e and effect for assessing the environmental risk of the proposed uses of oxathiapiprolin

................................ ................................ ................................ ................................ ............................. 20 Table 3.1. Labelled use patterns pro posed for oxathiapiprolin

................................ ................................ .................... 23 Table 3.2 Oxathiapiprolin identity and structure

................................ ................................ ................................ ......... 24 Table 3.3 Physical and chemical properties of oxathiapiprolin

................................ ................................ ................... 25 Table 3.4. F ate properties of oxathiapiprolin in abiotic systems (hydrolysis/aqueous photolysis) and photolysis on soil (Values are in % of the applied parent )

................................ ................................ ................................ ................. 25 Table 3.5 A summary of soil characteristics/radiolabel locations in submitted aerobic soil studies

........................... 27 Table 3.6. Summary of the fate properties of oxathiapiprolin in aerobic soil systems (refer to Abbreviations below the table)

................................ ................................ ................................ ................................ ................................ ...... 28 Table 3.7. Summary of the fate properties of oxathiapiprolin in aerobic/anaerobic soil system (refer to Abbreviations below the table)

................................ ................................ ................................ ................................ .... 30 Table 3.6 A summary of water and sediment characteristics/radiolabel locations in submitted aerobic/anaerobic

### 4 water/sediment studies

................................ ................................ ................................ ................................ ................. 32 Table 3.7 Summary of the fate properties of oxathiapiprolin in the aerobic water/sediment systems

......................... 32 Table 3.8 Summary of the fate properties of oxathiapiprolin in the anaerobic water/sediment systems

..................... 34 Table 3.8. A summary of soil characteristics/radiolabel locations in submitted aerobic soil studies

......................... 37 Table 3.9 Summary of the terrestrial field dissipation (TFD) data for oxathiapiprolin (Estimated half

- lives were for dissipation of the chemical in the whole soil profile)

................................ ................................ ................................ .. 38 Table 3.10. Adsorption coefficients for oxathiapiprolin in six soils along with the main characteristics of the soils (MRIDs 49011270 and 49011271)

. ................................ ................................ ................................ ............................. 40 Table 3.11. Transformation products (TPs) and degradates (DEGs) of oxathiapiprolin: water solubility in ppm @ 20

o C and octanol/water coefficient (K ow )

................................ ................................ ................................ ........................ 41 Table 3.12 Summary of the fate properties of transformation products/degradates of oxathiapiprolin in aerobic soil and in the field (parent is the test substance)

................................ ................................ ................................ ............... 43 Table 3

- 13 Summary of the fate properties of IN

- RAB06, a transformation product of oxathiapiprolin in soil systems (120 day study @ 20°C)

................................ ................................ ................................ ................................ .............. 43 Table 3.14 Summary of the fate properties of IN

- RDT31, a transformation product of oxathiapiprolin, in the aerobic soil systems (120 d study @ 20°C; MRID: 490112

- 56)

................................ ................................ .............................. 45 Table 3.15 Summary of the fate properties of IN

- E8S72, a degradation product of oxathiapiprolin, in the aerobic soil systems (120 d study @ 20°C)

................................ ................................ ................................ .............................. 45 Table 3.16 A summary of the adsorption data for selected TPs and DEGs of oxathiapiprolin

................................ ... 47 Table 3.17 Mean adsorption coefficients (K oc ) for selected TPs and DEGs as determined by the HPLC method

...... 48 Table 3.18. Summary of acute toxicity data to freshwater fish (rainbow trout

– Oncorhynchus mykiss ) exposed to the degradates of oxathiapiprolin

................................ ................................ ................................ ................................ . 52 Table 3.19. Summary of acute toxicity data to freshwater invertebrates (Water flea

– Daphnia magna ) exposed to the degradates of oxathiap iprolin

................................ ................................ ................................ ................................ . 54 Table 3.20. Summary of acute toxicity data to freshwater green algae ( Pseudokirchneriella subcapitata ) exposed to the degradates of oxathiapiprolin

................................ ................................ ................................ ................................ . 55 Table 3.21. ECOSAR Estimates of the oxathiapiprolin degradate 2, 6

- DFBA/IN

- YY147

................................ ......... 58 Table 3.22. S ummary of modeled foliar application parameters for oxathiapiprolin (refer to abbreviations, below)

. 59 Table 3.23. S ummary of modeled soil application parameters for oxathiapiprolin (refer to abbreviations, below; All
7

- d intervals between app lications).

................................ ................................ ................................ ............................ 60 31Table 3.24. Summary of the SWCC input parameters for oxathiapiprolin

................................ ............................. 61 Table 3.25. Summary of the maximum ECO EECs resulting from oxathiapiprolin use (all maximums were for soil application for crops for which application can be either to foliage or to soil; only foliar application is suggested for Brassica/bulb vegetables; Ginseng & turf)

................................ ................................ ................................ .................. 61 Table 3.26. Input parameters for deriving screening

- level terrestrial EECs for the proposed uses of oxathiapiprolin.

................................ ................................ ................................ ................................ ................................ ..................... 63 Table 3.27. Screeni ng

- level dietary

- based EECs (mg/kg diet) as food residues for birds and mammals for the proposed uses of oxathiapiprolin

................................ ................................ ................................ ................................ . 64 Table 3.28. Screening

- level dose

- based EECs (mg/kg

- bw) as food residues for birds and mammals for the proposed uses of oxathiapiprolin

................................ ................................ ................................ ................................ ................. 65 Table 3.29. Summary of the derivation of contact and dietary exposures used for foliar applications and soil treatments of oxathiapiprolin for Tier I risk assessment to honey bees.

................................ ................................ ...... 66 Table 3.30. Exposure estimates for contact and dietary exposures for adult honey bees resulting from foliar and soil applications of oxathiapiprolin.

................................ ................................ ................................ ................................ ... 67 Table 3.31. KABAM input values for oxathiapiprolin

................................ ................................ ............................... 68 Table 3.32. EECs for mammals and birds consuming fish contaminated by oxathiapiprolin

................................ .... 68 Table 4.1. Summary of acute toxicity data to freshwater fish exposed to oxathiapiprolin 1

................................ ........ 70 Table 4.2. Summary of chronic toxic ity data to freshwater fish exposed to oxathiapiprolin

................................ ...... 70 Table 4.3. Summary of acute toxicity data to freshwater invertebrates e xposed to oxathiapiprolin

........................... 71 Table 4.4. Summary of chronic toxicity data to freshwater invertebrates exposed to oxathiapiprolin

....................... 72 Table 4.5. Summary of acute toxicity data to estuarine/marine fish exposed to oxathiapiprolin 1

.............................. 72 Table 4.6. Summary of chronic toxicity data to estuarine/marine fish exposed to oxathiapiprolin

............................ 73 Table 4.7. Summary of acute toxicity data to estuarine/marine invertebrates exposed to oxathiapiprolin

................. 73

### 5 Table 4.8. Summary of chronic toxicity data to estuarine/marine invertebrates exposed to oxathiapiprolin

............. 74 Table 4.9. Summary of toxicity data to freshwater benthic invertebrates exposed to oxathiapiprolin

....................... 75 Table 4.10. Summary of toxicity data to vascular and non

- vascular aquatic plants exposed to oxathiapiprolin

........ 77 Table 4.15. Summary of acute oral toxicity studies for birds exposed to oxathiapiprolin

................................ .......... 79 Table 4.16. Summary of sub

- acute dietary toxicity data for birds exposed to oxathiapiprolin

................................ .. 80 Table 4.17. Summary of chronic toxicity data for birds exposed to oxathiapiprolin

................................ .................. 81 Table 4.18. Summary of acute and chronic toxicity data for mammals exposed to oxathiapiprolin

.......................... 81 Table 4.19. Summary of acute toxicity data for honey bees exposed to oxathiapiprolin

................................ ............ 83 Table 4.20. Summary of semi

- field study conducted with formulated oxathiapiprolin

................................ .............. 84 Table 4.22. Summary of toxicity data for terrestrial plants exposed to oxathiapiprolin

................................ ............. 86 Table 5.1. Summary of the levels of concern used for the risk quotient method.

................................ ........................ 88 Table 5.2. Summary of acute RQs for freshwater and estuarine/marine f ish resulting from the highest peak EECs from the proposed uses of oxathiapiprolin

................................ ................................ ................................ .................. 89 Table 5.3. Summary of chronic RQs for fresh water and estuarine/marine fish resulting from the highest 60

- day average EECs from the proposed uses of oxathiapiprolin

................................ ................................ ........................... 89 Table 5.4. Summary of acute RQs for freshwater and estuarine/marine invertebrates resulting from the highest peak EECs from the proposed uses of oxathiapiprolin

................................ ................................ ................................ ........ 90 Table 5.5. Summary of chronic RQs for freshwater and estuarine/marine invertebrates resulting from the highest
21

- day average EECs from the proposed uses of oxathiapiprolin

................................ ................................ ............... 90 Table 5.6. Acute RQ and Chronic RQs for Direct Effects to Freshwater Sediment

- Dwelling Invertebrates from Oxathiapiprolin. 1, 6

................................ ................................ ................................ ................................ ....................... 91 Table 5.7. RQ Values for Direct Effects to Aquatic Nonvascular Plants from Oxathiapiprolin. 1

............................... 94 Table 5.8. Acute Dietary

- Based RQs for Birds of Different Feeding Classes Exposed to Oxathiapiprolin 1 (Note: As a definitive acute dietary LC 50 was not achieved for birds, “>”, all RQs presented in this table are preceded with a “<.”)

................................ ................................ ................................ ................................ ................................ ............. 95 Table 5.9. Chronic Dietary

- Based RQs for Birds and Mammals of Different Feeding Classes Exposed to Oxathiapiprolin 1

................................ ................................ ................................ ................................ ........................... 95 Table 5.10. Acute Dose

- based RQ values for Birds and Mammals Exposed to Oxathiapiprolin 1,2,3 (Note: As a defi nitive acute oral LD 50 was not achieved for birds and mammals, “>”, all acute dose based RQs presented in this table are preceded with a “<.”)

................................ ................................ ................................ ................................ .... 96 Table 5.11. Summary of Tier I acute RQs to honey bees resulting from foliar and soil applied uses of oxathiapiprolin.

................................ ................................ ................................ ................................ ............................ 97 Table 5.12. Summary of acute and chronic RQs for freshwater and estuarine/marine fish resulting from the highest peak and 60

- day average EECs from the proposed uses of oxathiapiprolin

................................ ................................ 99 Table 5.13. Summary of acute and chronic RQs for freshwater and estuarine/marine invertebrates resulting from the highest peak and 21

- day averages from the proposed uses of oxathiapiprolin

................................ .......................... 100 Table 5.14. Summary of listed and non

- listed RQs for vascular and non

- vascular aquatic plants resulti ng from the highest peak EECs from the proposed uses of oxathiapiprolin

................................ ................................ ................. 101 Table 5.15. Summary of the acute and chronic risk pro file for oxathiapiprolin for birds and mammals

................. 102

### 6 I. E XECUTIVE 

### S UMMARY



### This ecological risk assessment addresses the new systemic fungicide active ingredient oxathiapiprolin

.
Oxathiapiprolin is proposed to be used as a f oliar spray of OD (oil dispersed) formulations on vegetables (brassica, bulb, cucurbits, fruiting, leafy, and tuberous/corm); ginseng; ornamentals; peas; and golf course turf. It may also be applied to soil as a suspension concentrate (SC) formulation on vegetables ( cucurbits, fruiting, leafy); ornamentals; and t obacco. T he product is delivered into the foliage or soil by conventional ground, aerial and air blast equipment , w ith the exception of application through transplant water, drench and chemigation

. The p roposed maximum application rates of oxathiapiprolin on crops range between 0.1245 lb. a.i/A/ year for most foliar applications and 0. 5006 lb . a.i /A / year for soil applications with 2 to 5 retreatment s (12 drench treatments in ornamentals) at a range of minimum intervals between 3 to 14 days. It i s i mportant to note th at oxathiapiprolin is to be applied to the plant foliage or to the soil but not both

.
Oxathiapiprolin is characterized by a relatively low water solubility with low potential for volatilization from dry/wet and water surfaces. The Octanol/water partition coefficient suggests that the chemical has the potential to bio

- concentrate in aquatic organisms such as fish. Oxathiapiprolin is not expected to be affected by hydrolysis, aqueous photolysis, and photolysis on soil and anaerobic soil metabolism. Additionally, the chemical is expected to be relatively persistent in the soil and water sedime nt systems. In these systems, bio

- transformation/bio

degradation are the major processes that are expected to affect the fate of oxathiapiprolin.

Potential Risks to Non

- target Organisms

Summary of the Major Risk Conclusions for Aquatic Taxa

Fish and Aquatic Invertebrates

. Oxathiapiprolin was determined to be too insoluble for its acute toxic effects to be determined. No acute effects to fish or invertebrates are expected. Chronic effects are not expected either, although a sublethal effect (lethargy) was observed at exposures much highe r than those expected in the environment.

Sediment

- dwelling invertebrates . Chronic effects to sediment

- dwelling invertebrates are expected from the proposed uses on cucurbit vegetables, fruiting vegetables , ginseng, tuberous vegetables , and ornamentals . The chronic risk quotient (RQ) exceeded the Level of Concern of 1 ( RQs ranged from 1.01

– 2.72 ) when calculated from sediment based exposure endpoints. However, the chronic LOC was not exceeded when the RQs were derived from pore water or water column expressed exposure endpoints.

The chronic LOC was exceeded only in the study where the water was spiked. In a study where the sediment was spiked instead, toxicity endpoints were an order of magnitude less, and did not exceed the chronic LOC. The disc repancy between the risk conclusions using endpoints from the

### 7 spiked water system versus the spiked sediment system represent an uncertainty given that chronic LOC exceedances were marginal for spiked water based RQs and were an order of magnitude below th e chronic LOC for spiked sediment based RQs.

Estuarine Sediment

- dwelling Invertebrates . N o data are available for estuarine/marine sediment

- dwelling invertebrates . Risk conclusions are similar to those for freshwater sediment

dwelling invertebrates (p o ssible chronic risk).

Aquatic Plants T here were no LOC exceedances of listed and non

- listed species of aquatic plants for the proposed uses of oxathiapiprolin. No adverse effects to aquatic plants are expected.

Incidents and Monitoring

. As oxathiap iprolin is a new active ingredient, there are no wildlife incidents reported

. Additionally

, no known monitoring data are available.

Summary of the Major Risk Conclusions for Terrestrial Animals and Plants

Birds and Surrogates (Reptiles and Terrestrial Amphibians). No avian Risk Quotient exceeded any acute dose or dietary

- based Level of Concern, nor any chronic dietary LOC . Risk to birds and their surrogates is not expected.

Mammals

. N o acute dose

- based or chronic dose and dietary

- based RQs exce eded their respective LOCs for mammals

. Mammals are not expected to be at risk from the use of oxathiapiprolin.

The modelling scenario generating the highest terrestrial EECs to estimate the RQs made several conservative assumptions to represent the cucurbit, fruiting, leafy vegetable

, and tobacco uses

. Despite these assumptions, as noted above, there were no acute or chronic LOC exceedances for birds and mammals.

Terrestrial Plants. No adverse effects to terrestrial plants are expected from the u se of oxathiapiprolin. The highest rates tested on plants, which was more than twice the highest proposed application rate, did not elicit a toxicity en d point at the 25% level. The no

- adverse effect concentration (NOAEC) also exceeded the maximum applica tion rate, reinforcing the conclusion of no adverse effects. As oxathiapiprolin is a new active ingredient, there are no reported incidents involving plants and oxathiapiprolin usage.

Honey Bees and Terrestrial Invertebrates

. The results of the Tier I a cute risk estimation to adult honey bees via direct contact and oral exposure resulting from foliar and soil applications indicate all RQs fall bel ow the terrestrial invertebrate acute LOC of 0.4. A Tier II semi field study (application within a tunnel to Phacelia (scorpionweed ) for formulated oxathiapiprolin (oil dispersion formulation) indicates that while there were significant effects on survival at Days 12 and 13 )

, as well as reductions in flight intensity on the day of application, the bees recovered from these effects during the course of the 25 day study. For both of these endpoints, when the entire Day of application (Day 0

- which represented the third application overall but sole application to

### 8 which bees were exposed to via direct contact) to Day 25 (study termination) interval was considered, all response variables related to colony health, mortality, and foraging behavior were similar to controls. The study tested application rates that repre sent 64% of maximum single application rates proposed for oxathiapiprolin. Based on the results of the Tier I risk assessment (acute contact and acute oral risk only to adult honey bees), and the indication that under the tested conditions of a semi

- fiel d design honey bee colonies showed recovery in multiple response variables, the proposed uses of oxathiapiprolin are not expected to significantly impact honey bees at the colony level.

Listed Species

The risk assessment determined that for certain proposed uses of oxathiapiprolin, that there were no acute or chronic LOC exceedances of any LOC all taxa assessed. For these uses, which include brassica vegetables, bulb vegetables, leafy vegetables, peas, tobacco, and turf, a “no effect” call can be ma de to listed species. For all other proposed uses that include cucurbit vegetables, fruiting vegetables, ginseng, tuberous vegetables, and ornamentals, there was at least one scenario assessed for which there was an exceedance of an LOC. For all uses wh ere there was an exceedance, the taxa concerned was freshwater sediment dwelling invertebrates exposed to oxathiapiprolin on a chronic basis. It is noted that for the tuberous vegetable use scenarios that were assessed, the highest RQ estimated was 1.01, marginally above the chronic LOC of 1.

Data Gaps and Uncertainties

The suite of ecotoxicity studies submitted for parent oxathiapiprolin and the various degradation products is extensive. Risk estimation determined there to be chronic risk above the l e v el of the LOC to freshwater sediment dwelling organisms for certain uses when endpoints were expressed in terms of sediment. This finding was true for endpoints derived from the spiked water system but endpoints derived from the spiked sediment system did not yield RQs above the LOC. No data are available to characterize the toxicity to estuarine/marine organisms . A waiver request (D427833, 6/17/2015) was submitted to waive the need for additional sediment toxicity studies to estuarine/marine invertebrat es. The Agency reviewed the request and has determined that the current suite of data for water column invertebrate indicate that estuarine/marine organisms are

not disproportionately more sensitive than freshwater organsisms. Additionally, as indicated above, the two chronic freshwater sediment toxicity studies indicate a level of risk below the level of concern for most of the proposed uses. For the uses that do exceed the chronic le v el of concern, the exceedances are marginal

. Therefore, given that longer term sediment toxicity studies, as opposed to the guideline subchronic 10

- day toxicity studies were submitted and classified as supplemental for freshwater invertebrates and the presumption of a similar level of risk to freshwater or estuarine/marine sediment dwelling organisms, no further studies characterzing the toxicity to estuarine/marine sediment dwelling invertebrates are not needed as they are determined to have little overall added value to the current risk picture. Therefor e, EFED recommended that the waiver request be approved.

### 9 Additionally, there are no data available to characterize the acute and chronic toxicity to honey bee larvae. Despite the available acute oral toxicity study showing no effects to adult honey bees, a chronic 10

- day study is not available to characterize any potentially sublethal effects from prolonged oral exposure to oxathiapiprolin. However, while no larval or chronic adult data are available, the reults of a Tier II semi field study exposing all life stages of bees to oxathiapiprolin

treated foliage indicate that after 25 days, all response variables of the treatment groups were of similar level to that of the negative control. Furthermore, several toxicity studies were submitted to characterize the acute contact and oral toxicity of technical oxathiapiprolin, its proposed formulations, and its various degradation products, including the ones shown to form in plant metabolism studies. These studies show a lack of toxicity up to and including the highest concentrations tested. Therefore, additional Tier I honey bee studies ( i.e acute and chronic larval toxicity studies as well as 10

- day adult chronic toxicity studies) are not needed at this time.

### 10 

## II. P ROBLEM 

## F ORMULATION



### Problem formulation provides a strategic framework for the risk assessment. It sets the objectives for the risk assessment and provides a plan for analyzing the data and characterizing the risk (US EPA 1998). By identifying the important components of the risk assessment process, it focuses the assessment on the most relevant ecological receptors (species), chemical properties, exposure routes, and endpoints. The structure of this risk assessment is based on guidance contained in U.S. EPA’s Guidance for Eco logical Risk Assessment (USEPA 1998) and is consistent with procedures and methodology outlined in the Overview Document (USEPA 2004).

2.1

. Nature of Regulatory Action

The purpose of this assessment is to evaluate the environmental fate and ecological risks for the proposed new registration of the chemical oxathiapiprolin . Under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), U.S. EPA is req uired to evaluate the potential of new pesticides (and new pesticide uses) to cause adverse effects to the environment. Potential effects to listed species (species on the Federal list of endangered and threatened wildlife and plants) are also considered u nder the Endangered Species Act in order to ensure that the registration of oxathiapiprolin is not likely to jeopardize the continued existence of such listed species or adversely modify their habitat. To these ends, this assessment follows U.S. EPA’s guid ance on conducting ecological risk assessments and policies for assessing risk to non

- target and listed organisms (U.S. EPA, 1998 and U.S. EPA, 2004).

2.2. Nature of the Chemical Stressor

2.2.1. Overview of Pesticide Usage

Oxathiapiprolin is proposed for application as suspension concentrate (SC) and oil dispersion formulations (OD) and proposed to be applied either as liquid spray to foliage or liquid spray/ drench /through irrigation systems to soil on a variety of crops ( brassica, leafy, cucurbit, fruiting, and tuberous vegetables, peas, tobacco, ginseng, ornamentals, and turf ). The chemical is a selective fungicide that is proposed to be used as preventive and curative (eradicate/control/suppress ) plant and soil born fungal diseases with r esidual a nd anti

- sporal effects . Oxathiapiprolin is locally systemic, translaminar chemical that moves systemically in the xylem. As will be discussed in details later, t he fungicide is proposed to be widely used in the US

to control/suppress Oomycete diseases thro ughout the growing season of many crops.

2.2.2 . Pesticide Type, Class, and Mode of Action

According to the Fungicide Resistance Action Committee (FRAC) 1 

### , o xathiapiprolin is the first in a novel chemical group of fungicides known as the piperidinyl thiazole isoxazoline s . The mode of

1 URL for FRAC: http://www.frac.info/docs/default

- source/publications/frac

- code

- list/frac

- code

- list

- 2015

- finalC2AD7AA36764.pdf?sfvrsn=4

### 11 action for oxathiapiprolin is not currently listed by FRAC. FRAC lists this chemical under a FRAC code of U 15 2 

### with a proposed target site as oxysterol binding protein (OSBP) inhib ition

. Use of this chemical is assumed to require resistance risk management because it is a single site inhibit o r and r esistance risk is assumed to be medium to high

. The registrant suggested that the target protein was determined to be the oxysterol

- bi nding protein (OSBP) by a combination of biochemical and genetic approaches. On the biochemical side, a binding assay and affinity purification identified the OSBP protein as the target site. On the genetic side, mutants resistant to the chemistry have m utations in the oxysterol

- binding domain of the OSBP and transformation of sensitive strains with a resistant form of the OSBP gene produces transformants resistant to the chemistry. Oxysterols play a key role in ergosterol biosynthesis, which are the fung al equivalent of cholesterols in mammalian cells and therefore are crucial in maintaining cell membrane structure and integrity.

Oxathiapiprolin has both agricultural crops and turf/ornamental uses that are proposed by DuPont and Syngenta, respectively. The r egistrants suggested that the chemical is active against diseases caused by oomycetes (downy mildew and late blight) in a range of crops. Fungicidal activity includes inhibition of zoospore release, encystment and mobility, as well as prevention of my celial growth in fungal species ( e.g. Phytopthphora spp. ). therefore, it is proposed to control a number of fungal diseases including phytophthora blight, crown rot, downy mildew, black shank, late blight, buckeye rot, pepper downy mildew, phytophthora root rot, pea downy mildew, lima bean downy mildew, pink rot, and blue mold.

2.2.3. Overview of Physicochemical, Fate, and Transport Properties

O xathiapiprolin 

### is characterized by a relatively low water solubility with low potential for volatilization from dry / wet and water surfaces

. The Octanol/water partition coefficient suggests that the chemical has the potential to bio

- concentrate in aquatic o rganisms such as fish. 

### Oxathiapiprolin is not expected to be affected by hydrolysis, aqueous photolysis, and photolysis on soil and anaerobic soil metabolism. Additionally, the chemical is expected to be relatively persistent in the soil and water sedimen t systems. In these soil and water sediment systems, b io

- transformation/bio

degradation are the major processes that are expected to affect the fate of oxathiapiprolin. Detailed physical/chemical fate and transport properties for oxathiapiprolin and its t ransformation products and degradates (hereafter referred to as TPs and DEGs, respectively) a re included in S ection 3 of this assessment.

2.2.4 . Stressor Source, Identity , and Intensity

The source of the stressor is application of the fungicide oxathia pipro lin to foliage or soil and the fate and transport of parent and resultant TPs/DEGs in important compartments of the environment

. In contrast, i dentity and intensity are based on ch aracterizing exposure and toxicity of the residues in these environmen tal compartments. In order to determine stressor identity and

2 U 15 : U = unknown mode of action and unknown resistance risk and the number refers to the time of product
introduction to the market

.

### 12 expected relative intensity, a complete analysis was conducted in which parent oxathiapiprolin was considered to be the stressor for both aq uatic and terrestrial systems. Details of this analysis are included in Section 3 of this assessment.

2.3. Ecological Receptors

The receptor is the biological entity that is exposed to the stressor (US EPA, 1998). Aquatic receptors potentially at risk include (but are not limited to): fish, a mphibians, invertebrates ( e.g ., aquatic insects, mollusks, crustaceans, and worms), vascular and nonvascular aquatic plants. Terrestrial receptors potentially at risk include (but are not limited to): birds, mammals, reptiles, amphibians, terrestrial inver tebrates ( e.g ., insects, worms, arachnids), and plants.

Consistent with the process described in the Overview Document (US EPA, 2004), this risk assessment uses the surrogate species approach in its evaluation of oxathiapiprolin . Toxicological data gener ated from surrogate test species, that are intended to be representative of broad taxonomic groups, are used to extrapolate to potential effects on a variety of species (receptors) included under these taxonomic groupings.

Acute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature are used to evaluate potential direct effects of pesticides to the aquatic and terrestrial receptors identified in this section. Since oxathiapiprolin is a new pestic ide active ingredient, the availability of open literature information on its toxicity is expected to be limited. The evaluation of available data can also provide insight into the direct and indirect effects of oxathiapiprolin on biotic communities due to loss of species that are sensitive to the chemical and changes in structure and functional characteristics of the affected communities

.

A summary of the taxonomic groups and the surrogate species tested to help understand potential acute ecological effe cts of pesticides to non

- target species is provided in Table 2 .1 . In addition, the table provides a preliminary overview of the potential acute toxicity of oxathiapiprolin by providing the acute toxicity classifications.

1 Table 2.1

. Tax onomic groups and example test s p ecies for potential effects of o xathiapiprolin.

Tax

ono mic Gro

up Exa mple (s) of Surr ogat

e Spec ies Acute Toxicity Classification

Bir ds 1 Mall ard duck ( Ana

s platy Practically non

- toxic

### 13 Tax

ono mic Gro

up Exa mple (s) of Surr ogat

e Spec ies Acute Toxicity Classification

rhyn chos ) Bob whit

e quail ( Coli

nus virgi
nian

us ) Zebr

a finch ( Poe phila
gutta

ta )

Ma

mm als Labo

rator y rat ( Ratt

us

norv egic

us ) Practically nontoxic

Inse

cts Hon

ey bee ( Apis melli fera ) Practically nontoxic

Fres hwa

ter fish

2 Blue gill sunfi sh ( Lep
omis

macr ochir

us ) Rain bow

trout Moderately toxic

### 14 Tax

ono mic Gro

up Exa mple (s) of Surr ogat

e Spec ies Acute Toxicity Classification

( Onc orhy nchu

s myki

ss )
Fres hwa

ter inve rteb

rate

s Wate rflea ( Dap hnia

mag

na ) Moderately toxic

Est uari ne/

mar ine fish Shee pshe ad minn

ow ( Cyp
rino don
varie gatu

s ) Moderately toxic

Est uari ne/

mar ine inve rteb

rate

s Mysi d ( Ame
rica mysi

s bahi

a )
East

ern oyste

r ( Cra

ssost

rea virgi
nica ) Very highly toxic

Terr estri al Mon

ocots

– onio Not classified

### 15 Tax

ono mic Gro

up Exa mple (s) of Surr ogat

e Spec ies Acute Toxicity Classification

plan

ts 3 n ( Alli

um
cepa ) Dico

ts

– soyb

ean ( Gly
cine

max )

Aqu atic plan

ts and alga

e Duc kwee d ( Lem

na gibb

a ) Cyan obac teria ( Ana baen

a flos

aqua

e ) Mari

ne diato

m ( Skel

eton

ema
costa

tum )
Fres hwat

er diato

m ( Nav icula pelli Not classified

### 16 Tax

ono mic Gro

up Exa mple (s) of Surr ogat

e Spec ies Acute Toxicity Classification

culos

a )
Fres hwat

er
gree

n algae ( P eu edok irchn eriell

a subc apita ta)

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 Freshwater fish represent 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, o f which one is soybeans.



### 2.4. Ecosystems at Risk

The ecosystems at potential risk from oxathiapiprolin are extensive in scope due to the wide geographic distribution of potential oxathiapiprolin application sites. In general terms, terrestrial ecosystems potentially at risk could include the treatment areas directly and adjacent areas that may receive drift or runoff. This could include the treatment area itself as well as other cultivated fields , fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats and other uncultivated areas. Aquatic ecosystems potentially at risk include water bodies adjacent to (or downstream from) the treatment area and might include im pounded bodies such as ponds, lakes, reservoirs and wetland areas, or flowing waterways such as streams and rivers. For uses in coastal areas, aquatic habitat also includes marine ecosystems, including estuaries and salt marshes.

2.5. 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 (US EPA, 1998). For oxathiapiprolin , the ecological entities may include the following: birds, mammals, freshwater fish and invertebrates, estuarine/marine fish and invertebrates, terrestrial plants, insects, and aquatic plants and algae. The attributes for each of these entities may include

### 17 growth, reproduction, an d survival and are discussed further in Section 2.7

.

2.6. 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 medium, a point of exposure for ecological receptors, and a plausible route of exposure.

The conceptual model is intended to provide a written descript ion and visual representation of predicted relationships between oxathiapiprolin , potential routes of exposure, and the effects related to the Agency assessment endpoints. The conceptual model consists of two major components: the risk hypothes i s and a co nceptual diagram (USEPA 1998).

2.6.1. Diagram

Based on the preliminary iterative process of examining fate and eff ects data, the conceptual model for spray application to agricultural crops (foliage and soil) has been established, refined and included in Figure s 2.1 and 2.2

. The referenced iterative process in establishing the diagram for the conceptual model

, it was necessary to go through an iterative process to identify: (1) likely stressors/exposure pathways and (2) organisms that are most relevant and applicable to this

assessment. It is noted that the conceptual model is established for the stressor which is parent oxathiapiprolin only; other TPs and DEGs are not included as it was decided that they are not of ecological concern as explained in Section 3

.

### 18 * F or Riparian plants terres trial exposure refer to Figure 2.2

, below



### 1 Figur e 2.1 An ecological conceptual model for aquatic exposure from application of oxathiapiprolin ( Note: Ingestion pathways should be solid lines)

As shown in Figure 2.1 , above, the p rimary exposure routes for aquatic organisms include spray drift and ru noff of oxathiapiprolin into nearby bodies of water. Once in the water, the primary exposure route to aquatic organisms is direct uptake across respiratory membranes (animals) and roots/integument (plants). Dietary uptake (ingestion) is considered to be a potentially important exposure pathway given the moderate bioaccumulation potential of oxathiapiprolin

.

In contrast, Figure 2.2 shows th at t he p rimary exposure routes for terrestrial organisms include direct contact with spray droplets, dermal contact wi th foliar residues, uptake from soil (plants and soil invertebrates) and consumption of contaminated foliage (herbivorous animals). Inhalation is not considered an exposure route of concern based on results of the Screening Tool for Inhalation Risk (STIR; version 1.0) model ( refer to Section 2.7.2 ). Additionally, ingestion of contaminated drinking water is a lso not considered a potential exposure route of concern based on results of Screening Imbibition Program (SIP; version 1.0; refer to Section 2.7.2 ) . Furthermore, the prim ary exposure routes of concern for managed bees (e.g., honey bees), include direct contact with spray 

## Stressor

Source

Receptors

Attribute Change Parent Oxathiapiprolin Applied to Foliage OR Soil

Spray drift

Aquatic animals: Fish/Aquatic phase amphibians Eggs, Larvae, Juveniles/Adults Invertebrates, Vertebrates

Individual organisms Reduced survival Reduced growth Reduced reproduction Food chain Reduction in algae and

vascular plants Reduction in prey Modification of PCEs

related to prey availability Habitat integrity Reduction in primary productivi Reduced cover Community change Modification of PCEs related to

habitat Surface water/ Sediment Runoff

Aquatic Animals Invertebrates Vertebrates 

## Exposure Media

Uptake/gills or integument

Ingestion Ingestion Atmospheric transport

Wet/dry deposition Soil Leaching to Groundwater

Uptake/gills or integument

Aquatic Plants Non

- vascular Vascular Uptake/cell, roots, leaves Riparian plants terrestrial
exposure pathways*

### 19 droplets, dermal contact with foliar residues, and ingestion through consumption of contaminated pollen, nectar and associated proc essed food provisions ( e.g., brood food, royal jelly, propolis). Exposure of hive bees via contaminated wax is also possible, although difficult to quantify at this time. Exposure of bees through contaminated drinking water is not expected to be nearly as important as exposure through direct contact or pollen and nectar (USEPA, 2014 ).

Stressor

Source

Attribute Change Parent Oxathiapiprolin Applied to Foliage Or Soil

Direct application Spray drift

Terrestrial vertebrates* Terrestrial Invertebrates and bees

I ndividual organisms Reduced survival Reduced growth Reduced reproduction Food chain Reduction in prey and food Modification of PCEs related to prey availability Habitat integrity Reduction in primary productivity Reduced cover Community change Modification of PCEs related
to habitat Terrestrial plants grasses/forbs, fruit, seeds (trees, shrubs) Runoff

Terrestrial vertebrates* 

### Exposure Media & Receptors Soil

Ingestion Ingestion Dermal uptake/Ingestion Atmospheric transport

Root uptake/contact
Wet/dry deposition

Ingestion Leaching to Groundwater Irrigation

water



### 2 Figure 2.2 An ecological conceptual model for terrestrial exposure from application of oxathiapiprolin

2.6.2 Risk Hypothesis

Risk hypotheses are specific assumptions about potential adverse effects ( i.e ., changes in assessment endpoints) and may be based on theory and logic, empirical data, mathematical models, or probability models (EPA 1998). The ensuing risk assessment will evaluate whether or not the specific risk hypotheses are supported. For oxathiapiprolin , the following ecological risk hypothesis is employed for th is ecological risk assessment:

Based on the environmental fate, systemic uptake, and distribution by plants and nature of f

oliar and soil applicati ons of oxathiapiprolin to crops, there is a potential that terrestrial and/or aquatic organisms will be exposed when oxathiapiprolin is used in accordance with the label. Oxathiapiprolin therefore has the potential to cause adverse effects upon the

### 20 survival, growth, and reproduction of non

- target terrestrial and aquatic plants and animals.

2.7. Analysis Plan

2.7.1. Methods of Conducting Ecological Risk Assessment

The primary method used to assess risk in this screening

- level assessment is the risk quotient (RQ) and follows closely methods outlined in the EPA Overview Document (USEPA, 2004). The RQ is the risk value for the screening

- level assessment and is the result of comparing measures of exposure to measures of effect. A c ommonly used measure of exposure is the estimated exposure concentration (EEC) and commonly used measures of effect include toxicity values such as the median lethal dose to 50% of the organisms tested (LD 50 

### ), medial lethal concentration to 50% of tested o rganisms (LC 50 

### ), the no observ ed adverse effect level (NOAEL) , and the no observed adverse effect concentration (NOAEC). The resulting ratio of the point estimate of exposure and the point estimate of toxicity, i.e., the RQ, is then compared to a specified level of concern (LOC), which represents a threshold for concern; if the RQ exceeds the LOC, risks concerns are triggered. Risk presumptions, along with the corresponding RQs, equations, and LOCs are summarized in Section 5 of this assessment

.

2.7.2 M easures of Aquatic Exposure

Screening

- level EECs of o xathiapiprolin in surface water, pore water and sediment were generated based on maximum labeled use rates discussed previously . Simulations were conducted using the tier II surface water concentration calculator (SWCC). For agricultural and certain non

- agricultural uses, exposure concentrations for surface ecological assessments are estimated based on EFED’s Tier II aquatic mode l PRZM/VVWM. A graphical user interface Surface Water Concentration Calculator (SWCC v.1.106, May 6, 2014), developed by the EPA, was used to facilitate inputting chemical and use specific parameters into the appropriate input files and chemical files. T he SWCC estimates pesticide concentrations in water bodies that result from pesticide applications to land. The calculator uses the Pesticide Root Zone Model (PRZM v5.0+, May 6, 2014) and the Varying Volume Wate r Body Model (VVWM, May 6, 2014 . EECs were determined using the standard pond scenario which represents a vulnerable surface water scenario for the VVWM component of the modeling exercise. For more information about the SWCC model refer to the EPA website 3



### .

2.7.3 Measures of Exposure

Measures of exposure are estimates for a receptor determined by modeling or monitoring data. Measures of exposure for oxathiapiprolin , are obtained from modeling efforts only, as this is a new chemical and national

- scale monitoring data are not expected to be present

. Exposure models used for this assessment include the suite of standard exposure models commonly used in pesticide risk assessments (USEPA, 2004). Generally, aquatic exposure estimates are generated from selected

3 URL: http://www.epa.gov/oppefed1/models/water/

### 21 EPA water models 4 

### and incorporate maximum proposed use rates, minimum application intervals, and empirically

- derived fate properties. Further details of the exposure models can be found in the Section 3 of th is assessment

.
Terrestrial wildlife are exposed to oxathiapiprol in via consumption of residues on food items generated by spray applications. For spray applications, the T

- REX model ( T errestrial R esidue
EX posure model; v. 1.5.2; June 6, 2013 5 

### ) is used to predict dietary exposure to oxathiapiprolin residues on foliar surfaces and insects using the Kenaga nomogram as modified by Fletcher (Hoerger and Kenaga 1972, Fletcher et al

. 1994). A default 35

- day foliar dissipation half

- life is used for terrestrial exposure modeling in this assessment, as suitable foliar dissipat ion data specific

to oxathiapiprolin are not available ( e.g. Willis and McDowell 1987). Estimated exposures of terrestrial insects to oxathiapiprolin are evaluated in terms of the insects’ potential relevance as dietary items for terrestrial vertebrates a nd for use in risk characterization for listed terrestrial invertebrates. For certain uses of oxathiapiprolin such as soil drench uses, T

- REX is unable to simulate labeled application methods . This is further discussed in Section 3 of this assessment

. The conceptual approach taken to estimate residues (upper

- bound and mean) in potential dietary sources for mammals and birds is presented in the model T

- REX Version 1.5.2

. The TerrPlant (v. 1.2.2; December 26, 2006) model is used to derive EECs relevant to terrestrial and wetland plants for the proposed uses of oxathiapiprolin . The model employs the assumption that default fractions of the intended application are transported to an adjacent field through runoff and spray drift. Measures of exposure to ter restrial plants are expressed as a fraction of the mass of the oxathiapiprolin applied to the treated field. The terrestrial models T

- REX and TerrPlant are available at the EPA web site 6



### The S creening T ool for I nhalation R isk (STIR v.1.0, November 19, 2010) was used to calculate an upper bound estimate of exposure using oxathiapiprolin’s vapor pressure and molecular weight for vapor phase exposure as well as the maximum application rate and method of application for spray drift. STIR incorporates resul ts from several toxicity studies including acute oral and inhalation rat toxicity endpoints obtained from the “six

- pack” of core studies, which are a series of six guideline studies (including acute oral, acute inhalation, acute dermal contact, and others) that are submitted to the Registration Division of the Office of Pesticide Programs for technical and formulated products of a pesticide (rat oral LD 50 

### = >5000 mg/kg bw, MRID 49011165 ; and rat inhalation LC 50 

### 5.1 mg/L, MRID 49011167 , respectively) as well as the most sensitive acute oral avian toxicity endpoint (bobwhite quail LD 50 

### >2250 mg/kg bw, MRID 49011283 ). Based on the results of the STIR model ( Appendix B ), exposure through inhalation of spray drift or the vapor phase of oxathiapiprolin was not de termined to be a potential pathway of concern for either avian or mammalian species on an acute exposure basis. Detailed information about STIR v.1.0, as well as the tool, can be found on the EPA website 7



### .

4 URL for EPA water model : http://www.epa.gov/oppefed1/models/water/index.htm

5 Information about the models can be found at http://www.epa.gov/pesticides/science/models_db.htm

6 URL for Terrestrial Models : http://www.epa.gov/oppefed1/models/terrestrial/

7 URL for STIR Model : http://www.epa.gov/pesticides/science/models_pg.htm#terrestrial

### 22 The S creening I mbibition P rogram (SIP v.1.0, rel eased June 15, 2010) was used to calculate an upper bound estimate of exposure using oxathiapiprolin’s solubility (0. 21 mg/L), and compared to the most sensitive acute and chronic avian and mammalian toxicity endpoints ( mallard acute oral
LD 50 

### of > 2250 mg a.i/kg

- bw and chronic NOAEC of 920 mg a.i/kg

- diet; rat acute oral LD 50 

### of >5000 mg a.i/kg

- bw and chronic reproduction NOAEL of 1210 mg a.i /kg

- bw/day

, respectively). Drinking water exposure alone was determined not to be a potential pathway of conc ern for avian and mammalian species on both an acute and a chronic exposure basis

. The output file for SIP can be found in Appendix C . Detailed information about SIP v.1.0, as well as the tool, can be found on the EPA website 8



### .
Finally , b ioaccumulation will be assessed using the results from bioaccumulation in fish studies, as well as the KABAM model (K OW 

### (based) Aquatic BioAccumulation Model, version 1.0, 2009), adjusting for biotransformation rates. KABAM is used to estimate potential bioaccumulation of hydrophobic organic pesticides in freshwater aquatic ecosystems and risks to mammals and birds

consum ing aquatic organisms which have bioaccumulated these pesticides. More information about this model can be found at the EPA website 9



### .

2.7. 4 . Measures of Effect

Measures of ecological effects are obtained from a suite of registrant

- submitted guideline st udies conducted with a limited number of surrogate species. The test species are not intended to be representative of the most sensitive species but rather were selected based on their ability to thrive under laboratory conditions. Measures of effect are b ased on deleterious changes in an organism as a result of chemical exposure. Functionally, measures of effect typically used in risk assessments include changes in survival, reproduction, or growth as determined from standard laboratory toxicity tests. The focus on these effects for quantitative risk assessment is due to their clear relationship to higher

- order ecological systems such as populations, communities, and ecosystems. In addition, effects other than survival, reproduction, and growth may be consi dered, rarely are they used quantitatively to estimate risks since, in many cases, the relationship between these effects and higher

- order processes is uncertain

.
Laboratory

- derived toxicity values include estimates of acute mortality ( e.g. , LD 50 

### , LC 50 

### ) and estimates of effects due to longer term, chronic exposures ( e.g. , NOAEC, NOAEL). The latter can reflect changes seen in mortality, reproduction, or growth. In general, for a given assessment endpoint

, the lowest ( i.e ., most sensitive) relevant measure of effect is used in estimating the RQ. In addition, for insect pollinators (honey bee), effects are also assessed at the colony level using semi

- field and/or full

- field studies. Measurement endpoints include colony strength, foraging activity, forager mor tality, and various measures of brood development.

Assessment endpoints and their respective measures of effect are listed in Table 2.2 below

.

8 URL for SIP Model: http://www.epa.gov/oppefed1/models/terrestrial/sip/ sip_user_guide.html

9 URL for KABAM: http://www.epa.gov/oppefed1/models/water/kabam/kabam_user_guide.html

### 23 2 Table 2.2. Summary of measures of exposure and effect for assessing the environmental risk of the proposed uses of oxathiapiprolin Assessment Endpoint Measure of Exposure Measure of Effect
1. Abundance ( i.e . survival, reproduction, and growth) of individuals and populations of birds 1

2. Abundance ( i.e . survival, reproducti on, and growth) of individuals and populations of mammals.

3. Survival and reproduction of individuals and communities of freshwater fish 2 and invertebrates.

4. Survival and reproduction of individuals and communities of estuarine/marine fish and invertebrates.

5. Survival and reproduction of individuals and communities of freshwater and estuarine/marine benthic organisms.

6. Perpetuation of individuals and populations of non

- target terrestrial plant species.

7. Maintenance and growth of indiv iduals and populations of aquatic vascular and non

- vascular plants Maximum (peak) residues on food items (foliar)

Maximum (peak) residues on food items (foliar)

Peak EEC (acute), 21

- day, and 60

- day surface water EEC (chronic) 3

Peak EEC (acute), 21

- day, and 60

- day surface water EEC (chronic) 3

21

- day pore water and sediment EEC 3

Estimates of runoff and spray drift to non

- target

areas

Peak surface water EEC 1a. Zebra finch and northern bobwhite quail acute oral LD 50 1b. Mallard duck and no rthern bobwhite quail sub

acute dietary LC 50 1c. Mallard duck and northern bobwhite quail chronic reproduction NOAEC and LOAEC

2a. Laboratory rat acute oral LD 50 2b. Laboratory rat multi

- generation reproduction chronic NOAEL and LOAEL

3a. Rainbow trout and bluegill sunfish acute LC 50 3b. Rainbow trout early life stage NOAEC 3c. Daphnid acute EC 50 3d. Daphnid chronic reproduction NOAEC and LOAEC

4a. Sheepshead minnow acute LC 50 4b. Sheepshead minnow chronic early life stage NOAEC and LOAEC 4c. Saltwater mysid acute LC 50 , estuarine/marine mollusk EC 50 based on shell deposition 4d. Saltwater mysid chronic reproduction NOAEC and LOAEC

5a. Freshwater midge subchronic NOAEC and LOAEC

6a. Monocot and dicot seedling emergence and vegetative vigor EC 25 val ues

7a. Lemna gibba EC 50 values based on yield and growth rate 7b. Algal EC 50 values based on cell density, growth rate, and biomass

LD 50 = Lethal dose to 50% of the test population; NOAEC = no

- observed adverse effect concentration; LOAEC = lowest

- observed adverse effect concentration; LC 50 = lethal concentration to 50% of the test population; EC 50/25 = effect concentration to 50/25% of the test population.

1 Acc ording to EFED risk assessment guidance, birds may be used as surrogates for terrestrial phase amphibians and reptiles

2 Accor ding to EFED risk assessment guidance, freshwater fish may be used as surrogates to aquatic phase amphibians

3 Based on a 1

- in

- 10 year ret urn frequency

### 24 

## III. E XPOSURE 

## A SSESSMENT



### 3.1 Use characterization

3.1.1 Oxathiapiprolin Labels

(1) DuPontTM ZorvecTM EnicadeTM: 10.2% oxathiapiprolin formulated as an oil dispersion (OD) . The product is foliar or soil applied; (2) DuPontTM ZorvecTM EpicaltrinTM: 18.7% oxathiapiprolin formulated as suspension concentrate (SC). The product is soil applied; and (3) Syngenta OXATHIAPIPROLIN FHG (OD formulation): 10.2% oxathiapiprolin formulated as an oil dispersion (OD) Proposed for control of diseases of ornamental plant s grown in greenhouses (including shade houses, lath houses and hoop houses), nurseries and outdoor ornamental plants grown in commercial landscapes and golf course turf. The chemical is applied to soil planted ornamentals or as drench in ornamentals grown in containers and as a foliar spray in turf.

3.1.2 Oxathiapiprolin Fungicide Characteristics

Oxathiapiprolin is a locally systemic, translaminar fungicide. The chemical moves systemically in the xylem

. The product has preventive, residual, curative, eradicative and anti

- sporal selective activity for Oomycete diseases ( fungal diseases ). It is a rain

- fast fungicide as it rapidly penetrates into plant tissues within 30 m inutes after spray residues have dried. For soil application, the product suspension should be applied to saturation of the crop root/crown zone before, during or soon after sowing or transplanting.

3.1.3 Crop Use Patterns

Proposed use patterns for oxathiapiprolin are summarized below in Table 3.1

. T here are no residential use s for this fungicide but it may be used in greenhouse tomatoes, peppers and edible peel cucurbits

. Greenhouse uses will not be addressed in this assessment as this use represents an incomplete exposure pathway.

The fungicide is proposed for use in the following crops:

• Brassica (Cole) leafy vegetables, head and stem Subgroup : Broccoli; broccoli, Chinese (gai lon); Brussels sprouts; cabbage; cabbage, Chinese; (napa); cabbage, Chinese mustard (gai choy); cauliflowe r; Cavalo broccolo; kohlrabi;

• Bulb vegetables (green, dry): Chive, fresh leaves; chive, Chinese, fresh leaves; daylily, bulb; elegans hosta; fritillaria, bulb; fritillaria, leaves; garlic, bulb; garlic, great

- headed, bulb; garlic, serpent, bulb; kurrat; l ady’s leek; leek; leek, wild; lily, bulb; onion, Beltsville bunching; onion, bulb; onion, Chinese, bulb; onion, fresh; onion, green; onion, macrostem; onion, pearl; onion, potato, bulb; onion, tree, tops; onion, Welsh, tops; shallot, bulb; shallot, fresh l eaves;

• Cucurbit vegetables : Chayote (fruit); Chinese waxgourd (Chinese preserving melon); citron

### 25 melon; cucumber (field and greenhouse); gherkin; gourd, edible (includes hyotan, cucuzza, hechima, Chinese okra); Momordica spp. (includes balsam apple, balsa m pear, bittermelon, Chinese cucumber); muskmelon (includes true cantaloupe, cantaloupe, casaba, Santa Claus melon, crenshaw melon, honeydew melon, honey balls, Persian melon, golden pershaw melon, mango melon, pineapple melon, snake melon, and other vari eties and/or hybrids of these); footnote (1)); pumpkin; squash, summer (field and greenhouse); squash, winter (includes butternut squash, calabaza, hubbard squash, acorn squash, spaghetti squash); and watermelon;

• Fruiting vegetables: African eggplant; bush tomato; bell pepper (field and greenhouse); cocona; currant tomato; eggplant; garden huckleberry; goji berry; groundcherry; martynia; naranjilla; okra; pea eggplant; pepino; nonbell pepper (field and greenhouse); roselle; scarlet

egg plant; sunberry; tomatillo; tomato (field and greenhouse); and tree tomato;

• Ginseng

• Leafy Vegetables Leafy Greens subgroup: Amaranth; arugula; chervil; chrysanthemum, edibleleaved; chrysanthemum, garland; corn salad; cress, garden; cress, upland; dandelio n; dock; endive; lettuce, head and leaf; orach; parsley; purslane, garden; purslane, winter; radicchio; spinach; spinach, New Zealand; spinach, vine;

• Peas, succulent, edible podded: Pisum spp., includes dwarf pea, edible

- pod pea, snow pea, and sugar snap pea;

• Tuberous and Corm vegetables: Potato; Arracacha; arrowroot; artichoke, Chinese; artichoke, Jerusalem; canna, edible; cassava, bitter and sweet; chayote (root); chufa; dasheen (taro); ginger; leren; sweet potato; tanier; turmeric ; yam bean; yam, true, and;

• Tobacco

3.1.4 Application Procedures

(1) Transplant Water application: The product is applied as a foliar spray to the transplants in the transplant tray 24

- 48 hours prior to transplanting followed immediately by spraying the foliage with water into th e transplant tray soil. Transplants are left for 24 hours before transplanting into the field. For this application, the acre of transplants receives the full recommended acre rate for transplant tray application; (2) Chemigation: The product is applied through drip (trickle) or strip tubing irrigation systems. Directions are provided to insure delivery of the product with irrigation water into the target root zone; (3) Drench: The product is applied as drench to soil; (4) Surface Band or Directed application: Th e product is applied in a 4 to 12 ” inch band. For each field (i.e., acre rate), t he equivalent rate is provided in a Table based on the crop row spacing (The t able p rovide s the rate in fl. Oz. product/1000 row of crop feet in inches)

. Th is type of applicati on is to be followed with cultivation or irrigation (0.5

- 1 inch) to move the product to the target root zone ; and (5) In

- furrow application : The product is applied in

- furrow at planting or lay

- by before planting.

With the exception of application through transplant water , drench, and chemigation, the product is delivered into the soil by: g round (using g round field sprayers ) ; a e r ial ( using aircraft ) ; or a i r

### 26 b last (using air assisted field ground sprayers )

.

3.1.5 Application Parameters for the Labe l led Use Patterns

Table 3.1 contains a summary of the proposed uses for the fungicide oxathiapiprolin along with important application parameters

.

3 Table 3.1. Labelled use patterns proposed for o xathiapiprolin

Crop Use Pattern (Product) Application Parameters 1

Notes MSR MNA 2 MTR MA I 3
Foliar Application for DuPontTM ZorvecTM EnicadeTM Brassica leafy vegetables 0.0311 2+2 0.1245 5

Full season foliar spray : Ground Airblast and Aerial Bulb vegetables 0.0311 2+2 0.1245 5 Cucurbit vegetables 0.0311 2+2 0.1245 3 Fruiting vegetables 0.0311 2+2 0.1245 5 Ginseng 0.2503 2 0.5006 14 Leafy Vegetables 0.0311 2+2 0.1245 3 Peas, succulent 0.0311 2+2 0.1245 5

Tuberous/Corm vegetable s 0.0311 2 0.0622
5 In season when disease develops. Assume using another fungicide before the 3 rd (7

- day) 0.026 0 1 0.026 0
0.0441 2 0.0882 10 At nickel

- sized tubers (flowering)

Total 5 0.1764 Ground Airblast and Aerial Soil Application for the OD formula tion (DuPontTM ZorvecTM EnicadeTM)

Cucurbit vegetables & Fruiting vegetables 0.0311 1 0.0311 * Transplant water application before planting
0.2503 1 0.2503 * Apply at plant with 7

- day intervals in furrow; *Assume using another fungicide before the 3 rd (7

- day). Ground ( G ) Airblast (AB ) and Aerial ( A ) 0.2192 1 0.2192 * Cucurbits/Fruiting Vegetables Total 3 0.5006 *

Leafy Vegetables 0.0623 1 0.0623 ** Transplant water application before planting
0.2503 1 0.2503 ** Apply at plant with 7

- day intervals in furrow; **Assume using another fungicide before the 3 rd (7

- day). G/AB/A 0.1880 1 0.1880 ** Leafy Vegetables Total 3 0.5006 **

Tobacco 0.0623 1 0.0623 *** Transplant water application before planting
0.2503 1 0.2503 *** Apply at plant with 7

- day intervals as soil directed or banded at 1 st cultivation and layby in furrow; ***Assume using another fungicide before the 3 rd (7

- day). G/AB/A 0.1880 1 0.1880 ***

Tobacco Total 3 0.5006 ***
Foliar and Soil Application of Syngenta OXATHIAPIPROLIN FHG (OD formulation)

Ornamentals: * Foliar application

* Soil Drench * Soil application 0.0311 2+2 0.1245 5 Aerial or Ground application to outdoor/ i ndoor plants

0.0415 12 0.5006 5 Ground drench to container grown plants / Chemigation

0.2503 2 0.5006 7 Ground a pplication to ground grown plants / Chemigation Turf (golf courses only: greens, tees and fairway) 0.2503 2 0.5006 10 Aerial or Ground application

1 Application Parameters: MSR= maximum single rate (lbs a.i./acre), MNA = maximum number of applications, MTR = maximum total rate (lbs a.i./acre/year), and MAI = Minimum application intervals in days);

### 27 Crop Use Pattern (Product) Application Parameters 1
Notes MSR MNA 2 MTR MA I 3

2 The label states that “ Make no more than 2 sequential applications before rotating to a fungicide with a different mode of

ac tion ”; Therefore , 2+2 means that make two sequential applications at the first two intervals, Assume no application at the fourth interval, then make another two applications at the 3 rd and 4 th interval. For example: the applications for Brassica will be a s follows: 1 st application of 0.0311 lb. a.i/A (assume April, 1), 2 nd application of 0.0311 lb. a.i/A after 5 days (April, 6), No application for the 3 rd interval of 5 days; 3 rd application of 0.0311 lb. a.i/A after 5+ the 5 days with no application (April, 16), and the last application of 0.0311 lb. a.i/A after 5 days (April, 21) ; and

3 Application is around planting date, if two applications it is assumed the interval in between is equal to 3 days in all crop s



### 3.2 Environmental Fate and Transport Characterization

Oxathiapiprolin is a systemic fungicide . The chemical is a 1:1 racemic mixture of IN

- Q7N24 and
IN

- Q7N25 ( Table 3.2 ). Registrant

- submitted data show s significant fungicidal activity with IN

Q7N24 and IN

- Q7N25, indicati ng that both of these enantiomers of oxathiapiprolin can bind effectively at the targeted binding site in fungal cells resulting in similar fungicidal efficacy

. Although it is possible to separate these two enantiomers, this was not done in fate and trans port studies. These studies were conducted with a 1:1 racemic mixture and chiral analysis of the soil and water/sediment extracts demonstrated that the racemic ratio remained unchanged. All submitted studies tracked the total amount of Oxathiapiprolin enantiomer s

.

4 Table 3.2 Oxathiapiprolin identity and structure

Common Name s Oxathiapiprolin ( DPX

- QGU42) Structures

1:1 racemic mixture of IN

- Q7N24 and
IN

- Q7N25

( R)

- oxathiapiprolin (IN

- Q7N24)

( S )

- oxathiapiprolin (IN

- Q7N25) IUPAC Nomenclature 1

- (4

- {4

- [(5RS)

- 5

- (2,6

- difluorophenyl)

- 4,5

- dihydro

- 1,2

- oxazol

- 3

- yl]

- 1,3

- thiazol

- 2

- yl}

- 1

- piperidyl)

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl]ethanone

CAS Name 1

- [4

- [4

- [5

- (2,6

- Difluorophenyl)

- 4,5

- dihydro

- 3

- isoxazolyl]

- 2

- thiazolyl]

- 1

- piperidinyl]

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl]

- ethanone

SMILES Code CC1=CC(=NN1CC(=O)N1CCC(C C1)C1=NC(=CS1)C1=NOC(C1)C1 =C(F)C=CC=C1F)C(F)(F)F

CAS Number 1003318

- 67

- 9 Molecular Weight 539.53 g mole

- 1

PC Code 128111

Molecular Formula C 24 H 22 F 5 N 5 O 2 S 

### N O S

N N

O N
N C H 3



### F F F F

F

### 28 3.2.1 Physical and Chemical Properties of oxathiapiprolin parent

A summary of the physical and chemical properties of oxathiapiprolin in included in Table 3. 3

.

5 Table 3.3 Physical and chemical properties of o xathiapiprolin

Property Description or Value Reference

Aqueous /solvent Solubility (20 ̊C) 211.1 ppb @ pH 4; 184.4 ppb @ pH 7 206.0 ppb @ pH 9; 174.9 ppb In water Acetonitrile= 130 g/L ; Methanol= 14 g/L ; Acetone= 163 g/L ; Ethyl acetate= 34 g/L ; Dichloromethane= 353 g/L ;

o

- Xylene= 6 g/L ;

n

- Octanol= 30 mg/L ; and

n

- Hexane= 10 mg/L Product Chemistry data

Vapor pressure & HLC @ 20 ̊ C 8.56 x 10

- 9 torr 3.474 × 10

- 8 atm m 3 mole

- 1

Log K ow @ 20 ̊C & pH 7
K ow @ 20 ̊C & pH 7 3.6 0 3,981 Product Chemistry data



### Based on data presented in Table 3.3, oxathiapiprolin 

### is characterized by a water solubility ranging from 184.4

– 211.1 ppb in alkaline

- neutral to acidic conditions. Water solubility appears to be low and to increase under increasing acidic or basic conditions. The highest expected environmental concentration (EEC) for the top 6” of the soil, resulting from the highest single ap plication of 0.25 lb a.i/A, is estimated

, by calculation

, to be 120 ppb . This EEC is not far from the solubility range of the chemical ( 179.4 ppb ) suggesting that much of the chemical is expected to be readily soluble depending on the availability of soil moisture and the extent of incorporation within the top soil. The chemical has low potential for volatilization from dry / wet and water surfaces (Vapor pressure = 8.6 x 10

- 9 

### torr and Henry’s Law constant= 3.5 x 10

- 8 

### atm m 3 

### mole

- 1 

### , respectively at 20°C). T he Octanol/water partition coefficient suggests that the chemical has the potential to bio

- concentrate in aquatic organisms such as fish.

3.2.2 Hydrolysis, Aqueous photolysis and Photolysis on soil for oxathiapiprolin parent

Table 3.4 contains a summary of the fate properties of oxathiapiprolin in abiotic systems and photolysis on soil. These properties are obtained from the following laboratory submitted studies: hydrolysis; aqueous photolysis in sterilized water 

### and natural water ; an d photolysis on soil.

6 Table 3.4. F ate properties of oxathiapiprolin in abiotic systems (hydrolysis/aqueous photolysis) and photolysis on soil ( Values are in % of the applied parent )

### 29 Property Description or Value & Other Relevant Information Reference

Hydrolysis half

- life @ 50 ° C Stable at pH 4, 7 and 9 MRID 490111

- 21

Aqueous photolysis half

lives @ 25 °C and 12 hrs. Light:12 Dark photoperiod ( A 15

- day study) 31 days (SFO) in sterile aqueous buffered solution at pH 7.0 45 days (SFO) in natural filter sterilized stream water, UK; pH 7.1 and 4.8% OC (organic carbon) Major Degradates 1 : IN

- P3X26 : Max= 14% @ end of study (EOS) Minor Degradates: IN

- RLD51 and IN

- RSA90 : Max= 4

- 5% for both degradates @ EOS

Other Degradation Products: Unidentified Degradates : Max= 39% @ EOS with NO decline observed 2

CO2: = <LOQ @ study termination MRID 490111

- 22

Soil photolysis half

- life @
2 0 °C and continuous irradiation ( A 15

- day study) 82 days (SFO) in moist Sassafras soil (40°N, Greensboro, NC, USA)

Soil used: Sassafras from MD/USA: a sandy loam soil (pH= 4.7, OC= 1.4% and cation exchange capacity (CEC) of 5 meq/100 g soil ) Major T Ps 3 & Degradates: None
Minor TP s & Degradates: TP: IN

- RDT31 : Max= 6% with slight to NO decline @ EOS and IN

- RAB06 : Max= 5% declining to 1

- 2% @ 7 d; Degradates : IN

- E8S72 : Max= 6% with NO decline observed @ EOS
, IN

- RLD51 & IN

- RSA90 : Max= 3% declined to 1% @ EOS, and IN

- WR791: was detected at low levels and was not quantified Other degradation Products: Unidentified Degradates: Max= 9% @ EOS with NO apparent decline

CO2: = <LOQ @ study termination

Un

- extracted Residues (UER): Max= 8% @ study termination MRID 490112

- 53

1 Degradates: Chemicals resulting from C leavage of the backbone structure ; SFO : Single first order kinetics ; 2 2 2 2 2

2 Multiple minor unidentified components that were NOT greater than 10% at any sampling interval or greater than 5% at any two consecutive sampling intervals or increasing and greater than 5 % at the end of the study. These degradates were separated into polar and non

- polar compound s in one water/sediment system in which % of the polar components, from total polar+ non

- polar, were observed to be 9% @ day 1 then increased to 18%

- 29% @ 4

- 10 days and up to 31% at the end of study (15 days) ;

3 TP s = Transformation products: Chemicals resulting from a change in moieties (i.e., the methyl group) that is

a ssociated with one of the rings with the backbone structure of the parent intact. Persistence: persistence is indicate by text : Bold = relatively persistent; Higlighted Gray = Showed no apparent decline and Bold Ittalic = Showed decline

.



### Based on data presented in Table 3.4 , aqueous and soil photo

- degradation of oxathiapiprolin are not expected to be significant

. Environmentally relevant aqueous photolysis half

- lives was estimated to be 31 days in sterilized water and 45 days in natural stream water. Half

- lives (t1⁄2) for photolysis on soil we re estimated at 82 days on moist soil . Photolysis in aqueous media did not cause mineralization of oxathiapiprolin to CO 2 

### (CO 2 

### <LOQ) but it produced the major transformation product IN

- P3X26 ( m ax imum formation of 14%) and the minor degradates IN

RLD51 and IN

- RSA90 ( maximum formations ranging from 4

- 5%). The major TP IN

- P3X26 did

### 30 not show decline while the other two minor degradates showed “no decline” or “no apparent decline .” Several unidentified degradates w ere observed reaching a total maximum of 39%.

Photolysis on soil did not cause mineralization of oxathiapiprolin to CO 2 

### (CO 2 

### <LOQ) and did not produce major transformation products/degradates. The process produced two minor transformation products: IN

- RDT 31 and IN

- RAB06 and four minor degradates: IN

- E8S72 , IN

RLD51, and IN

- RSA90. The transformation product IN

- RDT31 and degradate IN

- E8S72 reached maximum formation rates of 6% with no observed decline while the transformation product IN

RAB06 and degradates IN

- RLD51 and IN

- RSA90 declined after reaching maximum formation

rates of 3

- 5%. The d egradate IN

- WR791 was detected at low levels but was not quantified. Many unidentified degradates reached a maximum formation rate of 9% and u n

- extracted soil residues

reac hed a maximum of 8%.

Based on these results, photolysis in aqueous media and on soil are not expected to be major contributor s to dissipation of oxathiapiprolin in the natural environment. It is noted that, with the exception of the degradate IN

- RSA90, p hotolysis on soil produce s the same transform ation products ( IN

- RAB06 and IN

- RDT31) /degradates ( IN

- E8S72 and IN

- WR791) which form in aerobic soils. The d egradate IN

- RSA90 may be considered as unique to the photolysis pathway (in water/ on soil )

. Furthermore, the major aqueous photolysis TP IN

- P3X26 can be considered unique for this process as all other degradates were observed in aerobic soil and photolysis on soil. For structures of the unique aqueous photolysis TPs IN

- P3X26 and aqueous/soil ph otolysis DEG IN

RSA90, refer to Appendix A

.

3.2.3 Aerobic Soil Metabolism of oxathiapiprolin parent

Aerobic soil metabolism studies in five soils/three radiolabel positions incubated in the dark at
20°C with rates near 0.2 μ g a.i./g soil are available fo r oxathiapiprolin

. Table 3.5 contains a summary of properties of the soil systems used in these studies and associated radiolabeled positions.

7 Table 3.5 A summary of soil characteristics/radiolabel locations in submitted aerobic soil studies

MRID Label Location Soil Name, Location and Characteristics

490112

- 50 Pyrazole

- 5 and Thiazole

- 5

- 14 C Sassafras 1 , MD, USA: LS soil (pH 4.8, %OC= 0.9 and CEC= 6 meq/100 g)

490111

- 55 Pyrazole

- 5 and Isoxazoline

- 5

- 14 C Sassafras 2 , MD, USA: LS soil (pH 4.8, %OC= 0.8 and CEC= 5 meq/100 g)

490112

- 51 Pyrazole

- 5 and Thiazole

- 5

- 14 C Speyer 2.2, Germany: Sand (pH 6 .0 , %OC=1.9 and CEC= 8 meq/100g)
Tama, USA: SiCL soil (pH 6.4, %OC=2.5 and CEC=22 meq/100g)
Nambsheim, France: SL soil (pH 7.4, %OC= 1.6 and CEC=10 meq/100g)
Lleida, Spain: CL soil (pH 7.7, %OC= 1.2 and CEC= 27 meq/100g)

### 31 Positions of radiolabels: Pyrazole ring= ; Thiazole ring = and Isoxazoline ring = Non

- radiolabeled: Piperidine ring= and Benzene ring=



### Data obtained from aerobic soil studies are summarized in Table 3.6

. It is noted that this summary of the fate properties in aerobic soils are for the combined labels in tested soil systems although data were obtained separately for each radiolabel position/soil.

8 Table 3.6. Summary of the fate properties of oxathiapiprolin in aerobic soil systems (refer to Abbreviations below the table) N O S

N N

O N
N C H 3

F F F F

F

Study Description or Value & Other Relevant Information ( A bbreviations are below) 1 Reference

Aerobic Soil Metabolism @ 20 °C (120

- 134 days studies) t 1⁄2= 154 days (DFOP) in Sassafras 1 soil; 130 days (SFO) in Sassafras 2 soil; t 1⁄2= 116 days (SFO) in Speyer 2.2 soil; 95 days (DFOP) in Tama soil; t 1⁄2= 217 days (DFOP) in Nambsheim soil; 59 days (SFO) in Lleida soil
Near Major TPs & DEG s (% of the applied parent)

Chemical Range When? EOS D etected <LOQ DLN PRS

TP: IN

- RAB06 4

- 14% 7

- 120 0.4

- 10% 12 0/12 7/12 5/12

TP: IN

- RDT31 5

- 9% 7

- 120 4

- 9% 12 0/12 4/12 8/12

DEG: IN

- QPS10 3

- 9% 60

- 120 <LOQ

- 6% 6 1/ 6 4/ 6 1/ 6

DEG: IN

- E8S72 4

- 7% 30

- 120 2

- 7% 5 0/ 5 3/5 2/5 Minor TP s & D EGs (% of the applied parent)

TP: IN

- Q7D41 1

- 3% 15

- 120 <LOQ

- 3% 12 2/12 1/12 9/12

DEG : IN

- RLD51 3

- 4% 60

- 120 <LOQ

- 3% 4 0/12 2/12 2/12

DEG : IN

- WR791 Detected, n ot quantified Other degradation Products: Unidentified Degradates: Max= 6

- 30% @ EOS

CO2: Max= <LOQ

- 12% @ study termination

Un

- extracted Residues (UER): Max= 9

- 43% @ study termination MRIDs 490112

- 50/51/55

1 Abbreviations: Near Major TPs & Degradates: TP s = Transformation products: Chemicals resulting from a change in moieties (i.e., the methyl group) that is associated with one of the rings with the backbone structure of the parent kept intact; and Degradates: Chemicals resulting from c leav age of the backbone structure Range = Range of observed m aximums; When? = Days when maximums o ccurred; EOS = End of study c oncentration ; D etected = Number of systems with d etection ; <LOQ = Number of systems with Detection at <LOQ /Total number of systems; DLN = Number of systems with Observed Decline /Total number of systems; PRS = Number of systems with No Observed Decline /Total number of systems ; Kinetic fit for half

- life data: SFO : Single first order ; DFOP: Double first order parallel ; Persistence: persistence i s indicate by text : Bold = relatively persistent; Higlighted Gray = Showed no apparent decline and Bold Ittalic = Showed decline

. .

### 32 Aerobic soil data in Table 3. 6 indicate that oxathiapiprolin is a relatively persistent compound (90 th 

### percentile t 1⁄2= 161 days with a range from 59 to 217 days). The chemical appears to be affected by soil microbial degradation resulting in:

(1) Mineralization with variable production of CO 2 

### (<LOQ to 12%) which appears to be mainly associated with cleavage o f the thiazole ring of the parent structure; (2) Production of transformation products in which the backbone of the structure remained intact. These transformation products are IN

- RAB06 (Max imum formation of 14%), IN

- RDT31 (Max imum formation of 9%), and IN

- Q7D 41 (Max imum formation of 3%). The transformation products IN

- RDT31 and IN

- Q7D41 appear to persist with no apparent decline observed for IN

- RAB06. The observed transformation products are formed as a result of:

a. Hydroxylation of the methyl group on the pyraz ole ring followed by oxidation producing
IN

- RAB06; b. Hydroxylation of the piperidine ring producing IN

- RTD31; and

c. Loss of two hydrogen atoms from the isoxazoline ring producing IN

- Q7D41; (3) Production of degradation products resulting from cleavage in or betwee n certain rings of the structure of the parent, transformation products and/or degradates. These degradates are IN

QPS10 (Max imum formation of 9%), IN

- E8S72 (Max imum formation of 7%), IN

- RLD51 (Max imum formation of 4%) and IN

- WR791 (detected but not quantified). The degradate IN

QPS10 appear s to decline while no apparent decline was observed for IN

- E8S72 and IN

RLD51; and (4) Transformation into un

- identified degradates ranging from 6 to 30% and un

- identified un

extracted residues ranging from 9 to 43%.

A review was conducted for residues produced by parent radiolabelled at each of the three rings: pyrazole , thiazole and isoxazoline rings. These d ata suggest:

(1) Parent labelled at the three rings confirms produc tion of the transformation products: IN

RAB06, IN

- RDT31 and IN

- Q7D41; (2) Parent labelled at the pyrazole confirms parent cleavage , at the thiazole ring to produce degradates IN

- RLD51 and IN

- E8S72 and IN

- WR791. It appears that production of IN

- E8S72 and IN

- WR7 91 was a lso a result of cleavage of IN

- RDT31 , between the pyrazole and piper i dine rings. This was confirmed by an aerobic soil study with pyrazole

- 5

- 14 

### C IN

- RTD31, as the test substance

. In this study, degradate IN

- E8S72 was produced at a maximum level of 13% and IN

- WR791 at a maximum level of 5%; (3) Parent labelled at the thiazole and isoxazoline rings confirms parent cleavage to produce the degradate IN

- QPS10. It appears that both IN

- QPS10 may also be produced by cleavage of the structure of the TP IN

- RAB06, at two different positions, between the pyrazole and piperidine rings producing IN

- E8S72 and IN

- QPS10. Cleavage at the one of these positions was confirmed in another aerobic soil study using thiazole 5

- 14 

### C IN

- RAB06 as a test substance. In this study, the degradate IN

- QSP10 was produced at a maximum level of 2%. Additionally, cleavage at the second position was confirmed by the production of IN

- E8S72 (maximum of 1%) in an aerobic soil study using pyrazole

- 5

- 14 

### C IN

- RAB06 as a test substance; and

### 33 (4) Mineraliza tion with variable production of CO 2 

### (<LOQ to 12%) which appears to be mainly associated with cleavage of the thiazole ring of the parent structure.

It is noted that several aerobic soil systems (e.g. Nambsheim, Tama, Lleida soils) contain relatively high levels of un

- extracted residues (UER) remaining in the soil by the conclusion of the study (i.e., 19.9

- 38.2% UR at Day 120). It is also noted that the solvent extraction method used: (1) Acetonitrile: H 2 

### O (90:10); (2) Acetonitrile: H 2 

### O (90:10); (3) Ace tonitrile: 0.1 M NH 4 

### carbonate (70:30); and (4) Acetonitrile: 1 M formic acid (70:30) does not contain any non

- polar solvents, such as dichloromethane, in which oxathiapiprolin has a very high solubility (353 g/L). For this, the registrant was asked to pro vide an explanation for the high levels of UER in these soils and comment on whether different extraction systems were explored before deciding on the system of extraction used in these studies. The registrant responded with the following:

• Prior to initiat ing the GLP laboratory soil route and rate of degradation studies, a non

- GLP experiment was conducted in three soils (Sassafras, Tama and Gross

- Umstadt) in order to develop optimal extraction and HPLC systems

.

• Samples were collected at multiple sampling intervals and subjected to a variety of extraction procedures including acid, basic, polar and non

- polar solvents.

• Additional more non

- polar solvents such as 50/50 methanol/toluene or 90/10 THF/water were attempted, however these solvents did not release s ignificant amounts of applied radioactivity (generally <1

- 2%AR).

• Use of these non

- polar solvents made it much more difficult to analyze the extracts. The difficulty resulted from the additional added matrix material and the need to remove all the solvent prior to reverse phase HPLC analysis. In conclusion, the registrant stated that the UER consist of re

- incorporated 14 

### C into natural products and/or multiple minor strongly sorbed components.

Finally, the fate of oxathiapiprolin was studied in one soil in the laboratory under aerobic/anaerobic conditions . In this soil, oxathiapiprolin was applied to the soil then incubated under aerobic conditions for 30 days followed with anaerobic conditions for 120 days. Results obtained are

s ummarized in Table 3.7

.

9 Table 3.7

. Summary of the fate properties of oxathiapiprolin in aerobic/anaerobic soil system ( refer to Abbreviations below the table)

### 34 Study Description or Value & Other Relevant Information ( A bbreviations are below) 1 Reference

Aerobic/

Anaerobic Soil
Aerobic phase (30 days)

Anaerobic

Phase @ 20 °C (120 days study ) t 1⁄2= 1,505 days (SFO) in Sassafras, MD, USA: SL soil (pH 5.1, %OC= 0.9 and CEC= 5 meq/100 g) Near Major TPs& DEGs: None

Minor TP s & DEGs (% of the applied parent)

Chemical Start Range When? EOS D etected <LOQ DLN PRS

TP: IN

- RAB06 4% 4

- 5% 21

- 21 0% 2 0/2 2 /2 0/2

TP: IN

- RDT31 4% 4

- 5% 30

- 90 3

- 4 % 2 0/2 0 /2 2 /2

DEG: IN

- QPS10 2% 2% 30 0 % 1 0/1 1 / 1 0/1

DEG: IN

- E8S72 4% 4

- 5% 120 5% 1 0/ 1 0/ 1 1/ 1

DEG: IN

- WR791 Detected, Not quantified Other degradation Products: Unidentified Degradates: Max= 9

- 15% @ EOS

CO 2 : No new production after the aerobic phase

Un

- extracted Residues (UER): Max= 6

- 7% @ EOS MRID 490112

- 52

1 Abbreviations: Near Major TPs & Degradates: TP s = Transformation products: Chemicals resulting from a change in moieties (i.e., the methyl group) that is associated with one of the rings with the backbone structure of the parent kept intact; and Degradates: Chemicals resu lting from c leavage of the backbone structure Start = Concentration at the start of the anaerobic phase (only for aerobic/anaerobic study); Range = Range of observed

m aximums; When? = Days when maximums o ccurred; EOS = End of study c oncentration ; D etected = Number of systems with d etection ; <LOQ = Number of systems with Detection at <LOQ /Total number of systems; DLN = Number of systems with Observed Decline /Total number of systems; PRS = Number of systems with No Observed Decline /Total number of systems ; Kinetic fit for half

- life data: SFO : Single first order ; DFOP: Double first order parallel ; Persistence: persistence is indicate by text : Bold = relatively persistent; Higlighted Gray = Showed no apparent decline and Bold Ittalic = Showed decline

.



### In the aerobic phase, data indicate that the level of the TPs IN

- RAB06 and IN

- RDT31 ranged from
4

- 5% and the level of the degradates IN

- QPS10 and IN

- E8S72 ranged from 2

- 5%. Both IN

RAB06 TP and N

- QPS10 DEG declined to non

- detection ( Table 3.7 ) . However, T P IN

- RDT31 and DEG IN

- E8S72 showed no decline. In contrast, d ata suggest that very little transformation occurred during the 120 anaerobic phase with no new mineralization occurring to CO 2



### . This was reflected in the estimated 1,505 day half

- life of the c hemical for the anaerobic phase of the study suggesting that the chemical is not affected by metabolism in anaerobic systems. However, the
TP IN

- RAB06 and the DEG IN

- QPS10 forming in aerobic conditions ( i.e. , top soil) are expected to be significantly aff ected when leached into deeper anaerobic soil layers. This conclusion is especially important knowing that these two chemicals are moderately to slightly mobile.

3.2.4 Aerobic/Anaerobic Metabolism in Water/Sediment Systems for oxathiapiprolin parent

The a erobic and a naerobic metabolism of oxathiapiprolin was studied in two water/sediment systems with oxathiapiprolin radiolabeled at three positions: Pyrazole

- 5 14 

### C, Thiazole

- 5 14 

### C and

### 35 Isoxazoline

- 5 14 

### C . The two systems were incubated in the dark at 20 °C. Table 3.6 contains a summary of the properties of water/sediment systems used in these studies.

10 Table 3.6 A summary of water and sediment characteristics/radiolabel locations in submitted aerobic/anaerobic water/sediment studies

System System Name and Location 1 Label Location in the Chemical

Structure Water Sediment

MRID pH DOC (mg/L) Texture pH OC CEC (meq/100 g)

AEROBIC Swiss Lake Pyrazole

- 5 14 C Thiazole

- 5

- 14 C 5.8 28.4 LS 5.3 0.7% 4

490112

- 79 Calwich Abbey Lake Pyrazole

- 5 14 C Thiazole

- 5

- 14 C 6.7 25.9 SiL 7.1 4.9% 24

AN

AEROBIC Swiss Lake Pyrazole

- 5 14 C Thiazole

- 5

- 14 C 7.0 12.1 LS 5.1 0.6% 7

490112

- 80 Calwich Abbey Lake Pyrazole

- 5 14 C Thiazole

- 5

- 14 C 7.5 5.6 SiL 7.1 5.0% 31
Swiss Lake Pyrazole

- 5 14 C Isoxazoline

- 5

- 14 C 6.5 7.3 LS 5.1 0.8% 3

490112

- 81 Calwich Abbey Lake Pyrazole

- 5 14 C Isoxazoline

- 5

- 14 C 7.8 2.5 SiL 7.2 5.2% 15

1 Location : Swiss Lake : Chatsworth, Derbyshire, UK; Calwich Abbey Lake: Calwich, Ashbourne, Derbyshire, UK



### Table s 3.7 and 3.8 contains a summary of the fate properties of oxathiapiprolin in tested water/sediment systems. Data summarized in Table 3.7 are for the combined labels in the aerobic water/sediment systems.

11 Table 3.7 Summary of the fate properties of oxathiapiprolin in the aerobic water/sedi ment systems

### 36 Study Description or Value & Other Relevant Information ( A bbreviations are below) 1 Reference

Aerobic Aquatic Metabolism @ 20 °C ( 99 days studies) t 1⁄2= 45 days (SFO) in Swiss Lake, UK
t 1⁄2= 93 days (IORE) in C alwich Abbey Lake, UK

Near Major TPs & DEG s (% of the applied parent)

Chemical Range When? EOS Detected DLN PRS

TP: IN

- RYJ52 * 4

- 16% 28

- 99 3

- 8% 4 3/4 1/4

TP: IN

- Q7D41 6

- 12% 60

- 99 3

- 12% 4 1/4 3/4

TP: IN

- RSE01 7

- 10% 14

- 99 3

- 7% 4 3/4 1/4

TP: IN

- RAB06 3

- 10% 28

- 99 1

- 5% 4 3/4 1/4

TP: IN

- S2K66 2

- 9% 60

- 99 2

- 9% 3 0/3 3/3

1 IN

- RYJ52 = Combined two isomers

DEGs: None

Minor TP & D EGs : None Other degradation Products: Unidentified Degradates: Max= 15

- 40 % @ EOS

CO 2 : Max= 0.2

- 7 % @ study termination

Un

- extracted Residues (UER): Max= 7

- 17% @ study termination MRIDs 490112

- 79

* Abbreviations: Near Major TPs & Degradates: TP s = Transformation products: Chemicals resulting from a change in moieties (i.e., the methyl group) that is associated with one of the rings with the backbone structure of the parent kept intact; and Degradates: Chemicals resulting from c leavage of the backbone structure ; Range = Range of observed m aximums; Whe n? = Days when maximums o ccurred; EOS = End of study c oncentration ; D etected = Number of systems with d etection ; <LOQ = Number of systems with Detection at <LOQ /Total number of systems;
DLN = Number of systems with Observed Decline /Total number of systems; PRS = Number of systems with No Observed Decline /Total number of systems ; Kinetic fit for half

- life data: SFO : Single first order and IORE: Indeterminate order rate equation; Persistence: persistence is indicate by text : Bold = relatively persistent; Higlighted Gray = Showed no apparent decline and Bold Ittalic = Showed decline

.

### 37 12 Table 3.8 Summary of the fate properties of oxathiapiprolin in the anaerobic water/sediment systems

Study Description or Value & Other Relevant Information ( A bbreviations are below) 1 Reference

A na erobic Aquatic Metabolism @ 20 °C (120

- 134 days studies) t 1⁄2= 45 days (SFO) in Swiss Lake, UK t 1⁄2= 55 days ( SFO ) in Calwich Abbey Lake, UK t 1⁄2= 158 days (IORE ) in Calwich Abbey Lake, UK t 1⁄2= 49 days (SFO) in Swiss Lake, UK

Near Major TPs& DEGs (% of the applied parent) :

Chemical Range When? EOS Detected DLN PRS

TP: IN

- RYJ52 * 11

- 33% 100 11

- 33% 8 0/8 8/8

TP: IN

- RSE01 7

- 17% 28

- 60 4

- 7% 8 8/8 0/8

TP: IN

- S2K66 10

- 13% 100 11

- 13% 7 0/7 7/7

TP: IN

- Q7D41 4

- 8% 60

- 100 4

- 8% 8 0/8 8/8

2 IN

- RYJ52 = Combined two isomers

DEG : IN

- QFD61 5

- 20% 60

- 100 5

- 13% 6 3/6 3/6

DEG: 2,6

- DFBA/IN

- YY147 10

- 18% 100 10

- 18% 2 0/2 2/2

DEG: INS2K67 1

- 14% 60

- 100 1

- 9% 6 1/6 5/6

Minor TP s & D EGs (% of the applied parent)

TP : IN

- RBR89 2

- 2% 60

- 100 2

- 2% 4 0/8 4/4

DEGs: None Other degradation Products: Unidentified Degradates: Max= 9

- 15% @ EOS

CO2: Max= <LOQ

- 0.7 % @ study termination

Un

- extracted Residues (UER): Max= 6

- 7 % @ study termination MRID 490112

- 80/81

* Abbreviations: Near Major TPs & Degradates: TP s = Transformation products: Chemicals resulting from a change in moieties (i.e., the methyl group) that is associated with one of the rings with the backbone structure of the parent kept intact; and Degradates: Chemicals resulting from c leavage of the backbone structure ; Range = Range of observed m aximums; When? = Days when maximums o ccurred; EOS = End of study c oncentration ; D etected = Number of systems with d etection ; <LOQ = Number of systems with Detection at <LOQ /Total num ber of systems;
DLN = Number of systems with Observed Decline /Total number of systems; PRS = Number of systems with No Observed Decline /Total number of systems ; Kinetic fit for half

- life data: SFO : Single first order and IORE: Indeterminate order rate equati on; Persistence: persistence is indicate by text : Bold = relatively persistent; Higlighted Gray = Showed no apparent decline and Bold Ittalic = Showed decline

.



### Data in Table 3.7 suggest that oxathiapiprolin is relatively more stable in aerobic water/sediment systems (Range t 1⁄2 = 45

- 93 days and 90 th 

### percentile t 1⁄2 = 143 days “n=2”) compared to anaerobic aquatic systems (Range t 1⁄2 = 45

- 158 days and 90 th 

### percentile t 1⁄2 = 121 days “n =4”) ( Table 3.8 ). It is noted that data presented previously suggest that oxathiapiprolin half

- life in aerobic systems is in the range of 59 to 217 days with a 90 th 

### perce ntile t 1⁄2 of 161 days. Based on the 90 th 

### percent ile

### 38 half

- lives, it could be concluded that oxathiapiprolin persistence in aerobic soil systems> aerobic aquatic systems> anaerobic aquatic systems. In this respect, it is noted that differences in the 90 th 

### percentile half

- lives estimated for the aerobic aq uatic system was calculated from two values compared to four for the anaerobic system and therefore the difference may be a reflection of the estimation. Additionally, the following can also be concluded:

In the aerobic water/sediment systems:

a. Parent tra nsformed into five transformation products: i. Two showing no decline: IN

- Q7D41 and IN

- S2K66 with maximum formation of 12 to 9%, respect ively . These two TPs appeared to be produced by changes in the isoxazoline ring of the parent structure; and ii. Three showing decline: the two isomers of IN

- RYJ52, IN

- RSE01 and IN

- RAB06 with maximum formation of 16 to 10%, respectfully. The first two TPs appeared to be produced by changes in the isoxazoline ring of the parent structure. The third TP IN

RAB06 was produced from pa rent by hydroxylation of the methyl group of the pyrazole ring in the parent structure; b. No degradates were identified ;

c. Mineralization into CO 2 

### with maximums ranging from 0.4% (from the Pyrazole

- 5 14 

### C labels) to 7% (from Thiazole

- 5 14 

### C labels); and d. Transfor mation into un

- identified degradates ranging from 15 to 40% and un

- identified

un

- extracted residues ranging from 7 to 17%.

I n the anaerobic water/sediment systems:

a. Parent transformed into five transformation products: i. Four showing no decline: the two isomers of IN

- RYJ52, IN

- S2K66 and IN

- Q7D41 with maximum formation of 33, 13 and 8%, respect ively and IN

- RBR89 with a maximum formation of 2%. All these TPs appeared to be produced by changes in the isoxazoline ring of the parent structure noting the first three TPs were observed in the aerobic water/sediment systems and only IN

- RBR89 was unique to the anaerobic systems; and ii. One showing decline: IN

- RSE01 with a maximum formation of 17%. This TP is produced by changes in the isoxazoline ring of the parent str ucture; and b. Production of three degradates: i. Two showing no decline: 2,6

- DFBA/IN

- YY147 and IN

- S2K67 with maximum formation of 18 and 14%, respect ively . These two transformation products appear to form from parent cleavage at the isoxazoline ring; and ii. One showing no apparent decline: IN

- QFD61 with a maximum formation of 20% which appears to be produced from parent cleavage at the isoxazoline ring;

c. Mineralization into CO 2 

### with maximums ranging from <LOQ to 0.7% (from the All Labels); and d. Transformation into un

- identified degradates ranging from 9 to 15% and un

- identified

un

- extracted residues ranging from 6 to 7%.

### 39 3.2.4 Degradation Pathway for parent

Based on environmental fate studies, the degradation pathway for parent oxathiapiprolin is presented in Figure 3.1

.

TP= Transformation product: The whole structure is shown for only two transformation products IN

- RAB06 and IN

- RDT31 all other structures , only affected ring of the parent structure are shown for all others ; The Whole structure is shown for all of the degradates; Persistence: persistence is indicate by text : Bold = relatively persistent; Higlighted Gray = Showed no apparent decline and Bold Ittalic = Showed decline

. Maximum Observed Concentrations : Examples: Aero Soil= 14% means the maximum observed concentration in laboratory aerobic soil is equal to 14%. Same is applied for Aero Aq= Aerobic Aquatic and An

- aero Aq= Anaerobic Aquatic IN

- QPS10 Aerob Soil 9%

IN

- RLD51 Aerob Soil 4% O H

O N

O N
N C H 3

F F F IN

- RAB06 Aerob Soil= 14%

Aero Aq= 10% IN

- RYJ52 Isomers

Aerob Aq= 16%

An

- Aerob Aq= 33% IN

- S2K66 Aerob Aq= 9%
An

- Aerob Aq= 13%

IN

- QFD61

An

- aero Aq= 20% O C H 3 S

N N

O N
N C H 3

F F F

IN

- S2K67

An

- Aerob Aq= 14% O H

C H 3 S

N N

O N
N C H 3

F F F 2,6DFBA/IN

- YY147

An

- Aerob Aq= 18% O H O F

F

IN

- RDT31 Aerob Soil= 9% 

### Oxathiapiprolin Parent 1

1 2

2 3 4

3

5

6

IN

- RBR89 An

- Aerob Aq 2% 

### O IN

- RSE01 Aerob Aq= 10%

An

- Aerob Aq= 17% 

### O O H IN

- Q7D41 Aerob Soil 3% Aerob Aq= 12%

### 40 3 Figure 3.1 Degradation pathway, persistence and mobility of oxathiapiprolin in soils and aquatic systems as indicated from laboratory studies (refer to abbreviations below the table )

3.2.5 Field Studies: Terrestrial Field Dissipation of Parent Oxathiapiprolin

Terrestrial field dissipation studies were conducted at ten sites, six in North America and four in Europe. All studies were conducted on bare ground soils in areas representing various labeled soil applications. No crop was present although applications were conducted at the appropriate timing for fungicide applications to targeted crops in areas of proposed use. Only the oil dispersed (OD) formulation was used with one application ranging from 0.18 to 0.50 lbs a.i/A or two applications with the single a pplication ranging from 0.34 to 0.35 lbs a.i/A. These rates are representative of the proposed label rates. Table 3.8 contains a summary of the location, application parameters and characteristics of top 30 cm of the soils where the studies were executed.

13 Table 3.8. A summary of soil characteristics/radiolabel locations in submitted aerobic soil studies

Location Application Parameters 1 Characteristics of the Top Soil (0

- 30 cm) 2

Rate No Timing (Crop) Texture pH %OC CEC MRID No.

North Rose, NY, USA 0.50 One 25

- 06 (F

- veg) Loam To SiL 5.1
To 5.9 0.1 NR 490112

- 63

Raymondville, TX, USA 0.34

+ 0.34 Two 15

- 07 and 03

- 08 (F

- veg) SCL 8.4 0.4 23 490112

- 67 Citra, FL, USA 0.46 One 12

- 05 (Veg) Sand 6.6 0.6 4 490112

- 6 6 Porterville, CA, USA 0.50 One 14

- 04 (F

- veg) Loam 8.6 0.5 12 490112

- 59

Potage la Prairie, Manitoba, Canada 0.46 One 21

- 07 (potato) Loam 8.1 2.1
To 4.3 38 490112

- 6 4

Okanagan Falls, British Columbia, Canada 0.35

+ 0.34 Two 12

- 08 And 26

- 08 (F

- veg) SL 6.7 1.3 9 490112

- 6 5 Lyon

, France 0.18 One 04

- 06 (grape) Loam 7.0 1.2 14 490112

- 60 Lentzke, Germany 0.19 One 08

- 06 (potato) LS To SL 6.1 0.6 6 490112

- 61 Cambridgeshire,
UK 0.18 One 04

- 06 (potato) SCL To CL 7.5 10.4 42 490112

- 68 Seville, Spain 0.18 One 02

- 06 (Veg) SL To LS 8.0 0.6 13 490112

- 69

### 41 1 Application Parameters: Rate= Actual single rate applied in lbs a.i/A, No= Number of applications, Timing ( Crop )= Timing of the application in d ay

- month (Crop related to this timing: F

- veg= Fruiti ng vegetables, Veg= Vegetables) , NR = not reported

2 Characteristics of the Top Soil: Texture = USDA textural class: LS= Loamy sand, SL= Sandy loam, SiL= Silt loam, SCL= Sandy clay loam and CL= Clay loam; pH= pH in water; %OC = % Organic carbon= % Organic matt er/ 1.724; CEC = Cation exchange capacity in meq/100 g dry soil



### A summary of the fate properties of oxathiapiprolin in tested field soils is presented in Table 3.9

.

14 Table 3.9 Summary of the terrestrial field dissipation (TFD) data for oxathiapiprolin (Estimated half

- lives were for dissipation of the chemical in the whole soil profile)

Study Description or Value & Other Relevant Information Reference

T FD Studies ( 296

- 741 days studies) t 1⁄2= 27 days (IORE) in NY, USA t 1⁄2= 32 days (IORE) in TX, USA t 1⁄2= 81 days (IORE) in FL, USA t 1⁄2= 52 days (IORE) in CA, USA t 1⁄2= 205 days (SFO) in Manitoba, Canada t 1⁄2= 169 days (SFO) in B.C, Canada t 1⁄2= 42 days (IORE) in Lucenay, France t 1⁄2= 125 days (DFOP) in Lentzke, Germany t 1⁄2= 21 2 days (SFO) in Cambridgeshire, UK t 1⁄2= 104 days (DFOP) in Seville, Spain

MRIDs 490112

- 50/51/55 Near Major TPs & D EGs (% of the applied parent)

Chemical Range When ? EOS Detected DLN PRS

TP : IN

- RDT31 2.4

- 8.2% 5

- 308 0.5

- 2.9% 10 10/10 0/10

DEG : I N

- E8S72 3.5

- 1 1.5 % 15

- 328 0.3

- 4.8% 8 8/ 8 0 /8

Minor TPs & DEGs (% of the applied parent)

TP: IN

- RAB06 0.2

- 3.4% 29

- 328 0.2

- 0.7% 10 9/10 1/10

DEG: IN

- QPS10 0.1

- 0.8% 30

- 427 0.1

- 0.4% 8 5/8 3/8
Leaching Potential for parent, transformation products (TPs) and degradates (DEGs) as indicated by data on the observed detections below the 30 cm which includes: level (as % of applied), extent (as indicated by observed leaching depths in cm) and timing as indicated by the period, from application, for these

detections. Tracked chemicals were only parent; TPs INRDT31 and IN

- RAB06 and DEGs IN

- QPS10 and

IN

- E8S72. Chemicals observed below 30 cm were: parent at NY, B.C sites; all TPs and DEGs at NY, B.C and TX sites and only I N

- E8S72 degradate at Manitoba site

TFD Site

Location Parent Transformation Products/ Degradates

Extent (cm) Timing Max Level/timing Leaching
Potential Extent (cm) Timing Max Level/timing Leaching
Potential NY,

USA 30

- 70 100

- 403 days 2%

@ 50 d Yes (low) 30

- 70 150

- 403 days 0.3% @ (150 d) Yes (very low)
B.C,

Canada 30

- 70 28

- 719 days 2%

@ 254 d Yes (low) 30

- 70 52

- 546 days 1%

@ 368 d Yes (low)
TX,

USA None Observed No 30

- 50 52

- 202 days 2%

@ 52 d Yes (low)
Manitoba,

Canada None Observed No 30

- 50 475 day 0.2%

@ 475 d Yes (very low)

### 42 Study Description or Value & Other Relevant Information Reference

1 Near Major TPs & Degradates: Degradates: Chemicals resulting from C leavage of the backbone structure and TP= Transformation products: Chemicals resulting from a change in moieties (i.e., the methyl group) that is associated with one of the rings, intact backbone structure of the parent Abbreviations: Range = Range of Maximums; When? = Days Occurred; EOS = End of Study Concentration ; ND = Number of systems with No Det ection /Total number of systems; <LOQ = Number of systems with Detection at <LOQ /Total number of systems; DLN = Number of systems with Observed Decline /Total number of systems; PRS = Number of systems with No Observed Decline /Total number of systems ; Kinetic fit for half

- life data: SFO : Single first order ; DFOP: Double first order parallel and IORE: Indeterminate order rate equation; Persistence: persistence is indicate by text : Bold = relatively persistent; Higlighted Gray = Showed no apparent decline and Bold Ittalic = Showed decline

.



### Data in Table 3.9 suggest the following:

(1) Parent is relatively persistent: dissipation half

- lives ranged 27 to 212 days with a 90 th



### – percentile field dissipation half

- life of 136 days “n= 10”; (2) Parent transformed into one “near major” TP ( IN

- RDT31 with a max ranging, in all ten sites, from 2.4

- 8.2%) and one major degradate (IN

- E8S72 with a max ranging, in eight sites, from 3.5

- 11.5%); IN=E8S72 was not detected in two sites: FL and CA; noting that:

a. The decline of the transformatio n product IN

- RDT31 was to a range of 0.5

- 2.9% within a relatively long period of time ranging from 181 to 692 days. Calculated 90 th 

### percentile t 1⁄2 was calculated to equal 1,208 days; calculated from dissipation half

- lives for only two sites: CA= 80 days and Manitoba= 633 days. This is because this TP declined from a max of 5.4 to 0.9% in 231 days at CA and from a max of 3.0 to 0.5% in 692 days in Manitoba; and b. The decline of the Degradate IN

- E8S72 was to a range of 0.3

- 4.8% within a relatively long period of time ranging from 127 to 495 days. Calculated 90 th 

### percen tile t 1⁄2 was calculated to equal 127 days; calculated from dissipation half

- lives f or only 4 sites: Manitoba= 48 days;, NY= 85 days, TX= 112 days and British Columbia= 137 days. IN

- E8S72 declined from a max of 7.3 to 0.7% in 413 days at Manitoba site, from a max of 3.5 to 0.3% in 303 days at NY site, from a max of 11.5 to 4.2% in 150 d ays at TX site, and from a max of 6.4 to 2% in 413 days and British Columbia site; (3) Parent transformed into one minor TP ( IN

- R AB06 with a max ranging, in ten sites, 0.2

- 3.4% to 0.1

- 0.7% in 75 to 413 days) and one minor degradate (IN

- QPS10 with a max rang ing, in eight sites, from 0.1

- 0.8% to <0.1

- 0.4% in 92 to 413 days; IN

- QPS10) was not detected in two sites: Germany and Spain; and (4) No leaching for parent and tracked TPs and DEGs was observed below 30 and sometimes below 15 cm in six out of ten field soi ls. In the other four soils, studies suggest low leaching potential for parent, TPs and DEGs in two field soils (one in NY, US and one in British Columbia, Canada) while only TPs and DEGs showed low leaching in the other two field soils (one in TX, US and one in Manitoba, Canada). The level of leaching below the top 30 cm is low (Max imum formation = 2% of the applied for parent and ranges from 0.2 to 2% for TPs and DEGs). Leaching at these four sites extended to 50 or 70 cm from the soil surface ( Table 1

- 9 ).

### 43 Laboratory mobility for the tracked parent, TPs and DEGs suggested that parent is a hardly mobile compound (FAO mobility classification; 200 0 ) (Average K foc 

### = 12,800 mL/g “n=6”), INRDT31 and IN

- QPS10 are slightly mobile (Average K foc 

### = 1,168 and 4,880 mL/g “n=5”, respectively), IN

- RAB06 is moderately mobile (Average K foc 

### = 496 mL/g) and IN

- E8S72 is highly mobile (Average K foc 

### = = 7.3 mL/g). Observed field mobility for parent, INRDT31 and
IN

- QPS10 are in line with that suggested by laboratory mobility.

3.2.6 Environmental Chemistry Methods (ECMs) and Independent Laboratory Validation (ILVs) The registrant submitted ECMs and associated ILVs for water and soil (sediment). The limit of quantification of the method for water is 0.1 ppb and for soil is 1.0 μg/Kg . T he minimum level of concentrations for risk ranged from 17 to 230 ppb which is 2

- 3 order of magnitude more than the LOQ of 0.1 ppb for water. For the soil (sediment) the minimum level of concentrations for risk is 140 ppb which is two order of magnitude mo re than the LOQ of 1.0 μg/Kg for soil (sediment).

3.2.7 Environmental Mobility of Parent

Adsorption data for o xathiapiprolin indicate that the chemical is hardly mobile K foc 

### ranged from
4

, 350 to 45,586 mL g

- 1 

### with an average of 12,800 mL g

- 1 

### (n= 6 ) noting that one of the soils had much higher Koc (45,625 mL/g) that all other five soils in which Koc ranged from 4,350 to 7,288 mL/g ( Table 3.10 ).

15 Table 3.10. Adsorption coefficients for oxathiapiprolin in six soils along wit h the main characteristics of the soils (MRIDs 49011270 and 49011271 )

.

Soil Texture OC (%) pH (0.01 M CaCl 2 1:2) CEC meq/100g K foc (mL/g)
Drummer, USA Clay Loam 2.9 6.0 27 45, 625
Gross

- Umstadt, Germany Loam 1.2 7.1 12 4,354 Nambsheim, France Sandy Loam 1.4 7.5 9.2 7,281 Lleida, Spain Silty Clay 1.8 7.7 19.1 5,575 Sassafras #16, USA Sandy Loam 1.2 5.0 6.1 7,289 Porterville, USA Loam 0.8 7.4 12.8 6,733 Average 12,8 1 0



### Total desorption level ranges from 5 to 33% suggesting that once the chemical is sorbed, it will not be readily desorbed. This indicates that leaching to depths is expected to be limited in most cases. Due to the fact that the chemical is relatively persistent

, leaching may occur with time, especially i f the chemical reaches the ana erobic layers of the soil profile where it is expected to be nearly stable giving more time for leaching to occur.

In the field, no leaching for parent was observed below 30 cm and sometimes below 15 cm in six out of ten field soils. In the other four s oils, low leaching potential was suggested for parent, in two field soils (one in NY, US and one in B.C, Canada). The maximum concentration observed

### 44 these depths were low (2% of the applied) occurring after nearly two months to a year. These results conf irms laboratory adsorption data. Based on this field and laboratory data, leaching may occur with time at a very low concentrations.

3.3. Oxathiapiprolin Transformation Products/Degradates (TPs/DEGs)

3.3.1 Physical and Chemical Properties of the TPs/DEGs

Appendix 1 contains the names, CAS names, formulas and molecular weight s for all transformation products and degradates. Table 3.11 contains a summary on available data on water solubility and octanol partitioning coefficients reported for some of the TPs and DEGs. 16 17 Table 3.11. Transformation products (TPs) and degradates (DEGs) of oxathiapiprolin: water solubility in ppm @ 20 o 

### C and octanol/water coefficient (K ow 

### )

Chemical Solubility Log K OW K OW Chemical Structure

Transformation Products (TPs)

IN

- RDT31 1.04 2.95 891

IN

- RAB06 32

- 0.05 1

IN

- RYJ52 I somers :

IN

- RYJ52

- I1 No data 2.13 135

IN

- RYJ52

- I2 No data 2.24 174

IN

- S2K66 No data 3.41 2,570

TP: IN

- RSE01 0.108* 2.78 603 Degradates (DEGs)

DEG: IN

- E8S72 28,240

- 0.52 0

DEG: IN

- P3X26 No data 0.25 2 O O H S

N N

O N
N C H 3

F F F F

F

### 45 Chemical Solubility Log K OW K OW Chemical Structure

TP: IN

- QFD61 No data 2.05 112

TP: IN

- S2K67 No data 1.56 36

IN

- QPS10 No data

- 2.02 0

* EPISUIT E Data



### Data in Table 11

- 1 suggests that the transformation product IN

- S2K66 may concentrate in aquatic organisms such as fish and that the degradate IN

- E8S72 is highly soluble.

3.3.2 H ydrolysis, Aqueous photolysis and Photolysis on soil for the TPs/DEGs

No data is available.

3.3.3 Aerobic Soil Metabolism; Aerobic/Anaerobic Metabolism in Water Sediment Systems and Terrestrial Field Studies for the TPs/DEGs

Guideline metabolism studies are to be conducted for a sufficient length of time, or for a year, during which parent declines (for nearly two half

- lives) and TPs/DEGs form/decline. Studies submitted for oxathiapiprolin were conducted for a short period of time (120 days) during which the forma tion/decline of some of the TPs/DEGs were not observed. However, supplemental studies were submitted in which the test substances were selected TP s or DEG s

. The l atter studies are of added value as they confirm segment ( s ) of the proposed degradation pathw ay for the chemical. This section deals with the fate of selected TPs and DEGs based on data obtained from parent studies (parent is the test substance , oxathiapiprolin ) and TPs and DEGs studies (TEPs or DEGs are the test substances).

Parent studies suggested the expected fate of individual TPs/DEGs in quantitative/qualitative terms such as: concentration (as % of applied) with time, estimated half

- life (need sufficient data points from maximum formation to decline), and the observed persistence in qu alitative terms such as declined, no decline or no apparent decline. This data were summarized previously in separate sections of the parent fate and are included here for completeness ( Table 3.12 )

. O C H 3 S

N N

O N
N C H 3

F F F

O H C H 3 S

N N

O N
N C H 3

F F F

### 46 18 Table 3. 12 Summary of th e fate properties of transformation products/degradates of oxathiapiprolin in aerobic soil and in the field (parent is the test substance)

Chemical Description or Value & Other Relevant Information

Aerobic Soil 1 Terrestrial Field Dissipation 1 Aerobic Aquatic 1 Anaerobic Aquatic 1

IN

- RAB06 No AD; t 1⁄2= ND Declined; t 1⁄2= ND Declined; t 1⁄2= 45 & 119 d Not Detected

IN

- RDT31 No D; t 1⁄2= ND Declined ; t 1⁄2= 80 & 633 d 2 Not Detected Not Detected

IN

- Q7D41 No D; t 1⁄2= ND Not Tracked No Decline; Stable No D; t 1⁄2= ND

IN

- RYJ52 Isomers Not Detected Not Tracked Declined ; t 1⁄2= 68 & 29 d No D; t 1⁄2= ND

INRSE01 Not Detected Not Tracked Declined; t 1⁄2= 23 & 95 d Declined; t 1⁄2= ND

IN

- S2K66 Not Detected Not Tracked No D; t 1⁄2= ND No D; t 1⁄2= ND

IN

- E8S72 No AD; t 1⁄2= ND Declined; t 1⁄2= 48, 85, 112 & 137 d 3 Not Detected Not Detected

IN

- QPS10 Declined; t 1⁄2= ND No AD; t 1⁄2= ND Not Detected Not Detected

IN

- RLD51 No AD; t 1⁄2= ND Not Tracked Not Detected Not Detected

IN

- QFD61 Not Detected Not Tracked Not Detected No AD; t 1⁄2= ND

2,6

- DFBA/IN

- YY147 Not Detected Not Tracked Not Detected No D; t 1⁄2= ND

INS2K67 Not Detected Not Tracked Not Detected No D; t 1⁄2= ND

IN

- RBR89 Not Detected Not Tracked Not Detected No D; t 1⁄2= ND

1 Length of study and reference MRID No.: A erobic Soil (120 day @ 20°C, MRIDs: 490112

- 50/51/55 ); Terrestrial Field Studies (>year, MRIDs: 490112

- 50/51/55 ); Aerobic Aquatic (99 d @ 20°C, MRID 490112

- 79); and Anaerobic Aquatic (100 d @ 20°C, MRIDs 490112

- 80/81); 2 At CA & MB;

3 At MB, NY, TX & BC, respectively; Abbreviations: No D= No decline; No AD= No apparent decline; ND= Not determined



### Table 3.12 contain s a summar y of the fate properties of oxathiapiprolin transformation product
IN

- RAB06 in aerobic soil systems.

19 Table 3

- 13 Summary of the fate properties of IN

- RAB06, a transformation product of oxathiapiprolin in soil systems (120 day study @ 20°C)

IN

- R AB06 : label positions: Pyrazole ring ; Thiazole ring

Aerobic Soil Metabolism Half

- Lives and Other Relevant Information

### 47 IN

- RAB06 is the test substance (Radiolabeled at the pyrazole ring); MRID 490112

- 57

t 1⁄2= 113 days (DFOP) in Speyer 2.2 (Germany): LS soil (pH 5.2, %OC= 1.6 and CEC= 9 meq/100 g)

t 1⁄2= 75 d ays (IORE) in Lleida (Spain): Clay soil (pH 7.5, %OC= 1.9 and CEC= 15 meq/100 g) t 1⁄2= 76 days (SFO) in Tama (USA): SiCL soil (pH 5.8, %OC= 2.3 and CEC= 17 meq/100 g) t 1⁄2= 64 days (IORE) in Nambsheim (France): SL soil (pH 7.3, %OC= 1.6 and CEC= 9 meq/100 g) t 1⁄2= 69 days (SFO) in Cajon (USA): SL soil (pH 7.3, %OC= 0.7 and CEC= 14 meq/100 g) Major Degradates: None Minor Degradates: IN

- E8S72 : Max= <LOQ

- 0.9% with an EOS Max= <LOQ

- 0.6% with NO apparent decline Other Degradation Products: Unidentified Degradates: Max= 5

- 12% @ EOS with NO Decline

CO2: = 12

- 27% @ study termination

Un

- extracted Residues (UER): Max= 34

- 47% @ study termination Volatile Organic Compound (VOCs): Max= 0.6

- 1.2% @ stud y termination

(b) IN

- RAB06 is the test substance (Radiolabeled at the thiazole ring) ; MRID 490112

- 54

t 1⁄2= 201 days (SFO) in Speyer (Germany): LS soil (pH 5.5, %OC= 3.4 and CEC= 8 meq/100 g) t 1⁄2= 23 days (DFOP) in Lleida (Spain): Clay soil (pH 7.6, %OC= 2.4 and CEC= 19 meq/100 g) t 1⁄2= 70 days (DFOP) in Tama (USA): SiCL soil (pH 6.0, %OC= 1.9 and CEC= 18 meq/100 g) t 1⁄2= 23 days (DFOP) in Nambsheim (France): SL (pH 7.4, %OC= 1.7 and CEC= 11 meq/100 g)

t 1⁄2 = 215 days (DFOP) in Sassafras (USA): Loam soil (pH 5.1, %OC= 1.5 and CEC= 8 meq/100 g) Major Degradates: None Minor Degradates: IN

- QPS10 : Max ≤ 0.4

- 2.2% with NO apparent decline @ EOS Other degradation Products: Unidentified Degradates: Max=15

- 24% @ 14

- 90 d with 15

- 19% @ EOS with NO apparent Decline

CO2: Max= 12

- 49% @ study termination

Un

- extracted Residues (UER): Max= 11

- 44% @ study termination with NO Decline Volatile Organic Compound (VOCs): Max= 0.1

- 0.3% @ study termination



### Data in Table 3.13 Suggest that the transformation product IN

- RAB06 is a relatively persistent compound in two out of ten soils (t 1⁄2 range d from 23 to 215 with a 90 th 

### perce ntile t 1⁄2 = 122 days). It is noted that some of the soils have a wide range of half

- lives. For example the range is 113

- 201 days for Speyer soil and 23

- 75 days for Lleida soil. Only th e minor degradate IN

- E8S72 (Maximum formation of 1% of the applied with no apparent decline) was observed when the compound was labeled at the pyrazole ring and IN

- QPS10 (Max imum formation of 2% of the applied with no apparent decline) when the compound was labeled at the thiazole ring. Mineralization to CO 2 

### was the major degradation processes for this transformation product (evolved CO 2 

### ranged from 11 to 47%)

Table 3.14 contain s a summar y of the fate properties of oxathiapiprolin transformation product
IN

- RDT31 in aerobic soil systems.

### 48 20 Table 3.14 Summary of the fate properties of IN

- RDT31, a transformation product of oxathiapiprolin, in the aerobic soil systems (120 d study @ 20°C; MRID: 490112

- 56)

IN

- RDT31 : label position: Pyrazole ring

Half

- Lives and Other Relevant Information

t 1⁄2= > 1,000 days (DFOP) in Speyer (Germany): LS soil (pH 5.3, %OC= 1.9 and CEC= 9 meq/100 g) t 1⁄2= 85 days (DFOP) in Lleida (Spain): Clay soil (pH 7.5, %OC= 2.0 and CEC= 17 meq/100 g) t 1⁄2= >1,000 days (IORE) in Tama (USA): SiCL soil (pH 5.7, %OC= 1.9 and CEC= 19 meq/100 g) t 1⁄2= 81 days (DFOP) in Nambsheim (France): SL soil (pH 7.4, %OC= 1.7 and CEC= 10 meq/100 g) t 1⁄2= >1,000 days (DFOP) in Sassafras (USA): Loam soil (pH 5.1, %OC= 3.1 and CEC= 8 meq/100 g) Major Degradates: IN

- E8S72 : Max= 5.4

- 13.7 % with an EOS Max= 1.9

- 7.3% with a decline Minor Degradates: IN

- WR791 : Max= 3.7

- 5.2% with an EOS Max= 1.6

- 3.7% with a decline Other Degradation Products: Unidentified Degradates: Max=16

- 24% @ EOS with NO apparent Decline

CO 2 : = 0.1

- 0.8% @ study termination

Un

- extracted Residues (UER): Max= 4

- 35% @ study termination with NO apparent Decline Volatile Organic Compound (VOCs): Max= 0

- 0.2% @ study termination



### Data in Table 3.14 s uggest that the transformation product IN

- RDT31 is highly persistent in three

out of five soils tested (Tama, Speyer and Sassafras soils with t 1⁄2 = > 1,000 days) and much less persistent in two (Nambsheim and Lleida soils with t 1⁄2 ranging from 81

- 85 days). Only two minor degradates formed: IN

- E8S72 (reached a Max of 13% of the applied then declined) and IN

- WR791 (rea ched a m ax imum formation of 5% of the applied then declined).

Table 3.15 contain s summar ies of the fate properties of oxathiapiprolin d egradates IN

- E8S72 (labelled at the pyrazole ring) and IN

- QPS10 (labelled at the thiazo le ring), respectively. For IN

E8S72 degradate, five soil systems were used and four were used for IN

- QPS10 degradate.

21 Table 3.15 Summary of the fate properties of IN

- E8S72, a degradation product of oxathiapiprolin, in the aerobic soil systems (120 d study @ 20°C)

IN

- E8S72: : label position: Pyrazole ring IN

- QPS10: label position: Thiazole ring

Half

- Lives and Other Relevant Information

### 49 IN

- E8S72 (MRID 490112

- 55)

t 1⁄2= 477 days (SFO) in Speyer (Germany): LS soil (pH 5.2, %OC= 1.7 and CEC= 9 meq/100 g) t 1⁄2= 271 days (SFO) in Lleida (Spain): Clay soil (pH 7.7, %OC= 1.9 and CEC= 17 meq/100 g) t 1⁄2= >1,0 00 days (SFO) in Tama (USA): SiCL soil (pH 6.4, %OC= 2.2 and CEC= 18 meq/100 g) t 1⁄2= 328 days (SFO) in Nambsheim (France): SL soil (pH 7.6, %OC= 1.5 and CEC= 11 meq/100 g) t 1⁄2= 379 days (SFO) in Sassafras (USA): SL soil (pH 5.1, %OC= 1.2 and CEC= 7 meq/100 g) Major Degradates: None Minor Degradates: None Other Degradation Products: Unidentified Degradates: Max=5

- 6% @ EOS with NO apparent Decline

CO 2 : = 0.7

- 3.3% @ study termination

Un

- extracted Residues (UER): Max= 7

- 21% @ study termination with NO apparent Decline Volatile Organic Compound (VOCs): Max= 0.1

- 0.2% @ study termination

IN

- QPS10 (MRID 490112

- 58)
t 1⁄2= 364 days (SFO) in Speyer: LS soil (pH 5.3, %OC= 1.9 and CEC= 9 meq/100 g) t 1⁄2= 75 days (DFOP) in Lleida: Clay soil (pH 7.5, %OC= 2.0 and CEC= 17 meq/100 g) t 1⁄2= 83 days (DFOP) in Nambsheim: SL (pH 7.4, %OC= 1.7 and CEC= 10 meq/100 g) t 1⁄2= 262 days (SFO) in Sassafras: Loam soil (pH 5.1, %OC= 3.1 and CEC= 8 meq/100 g) Major Degradates: None

Minor Degradates: None Other degradation Products: Unidentified Degradates: Max=26

- 48% @ 7

- 90 d with 16

- 28% @ EOS with a Decline

CO 2 : Max= 0.4

- 0.9% @ study termination

Un

- extracted Residues (UER): Max= 19

- 45% @ study termination with NO Decline Volatile Organic Compound (VOCs): Max= 0.1

- 0.3% @ study termination



### Data in Table 3.15 s uggest that the degradate IN

- E8S72 is a highly persistent compound (t 1⁄2 ranged from 271 to >1,000 days). Limited mineralization to CO 2 

### occurred (maximum evolved CO 2 

### ranged from 0

. 7 to 3.3% with a maximum of 5% un

- identified degradates and a maximum of 21% un

- extracted residues. IN

- QPS10 appeared to persist in two out of four soils (Sassafras and Speyer soils with t 1⁄2 = 262 and 364 days. Less persistence was observed in the other t wo soils (Lleida and Nambsheim soils with t 1⁄2 = 75 and 83 days).

3.3.4 Environmental Mobility of TPs and DEGs

Adsorption/desorption data were submitted for two of oxathiapiprolin TPs IN

- RAB06 and IN

RDT31 (MRIDs 490112

- 76 and 490112

- 73, respectively) a nd two degradates IN

- E8S72 and IN

QPS10 (MRIDs 490112

- 75 and 490112

- 74). This data is summarized in Table 3.16

.

### 50 22 Table 3.16 A summary of the adsorption data for selected TPs and DEGs of oxathiapiprolin

Soil Texture OC (%) pH ( 0.01 M CaCl 2 1:2) CEC meq/100g K foc (mL/g)


### IN

- RAB06 Transformation Products

Tama , USA Silty clay loam 1.9 18 6.0 521
Sassafras , USA loam 1.5 8 5.1 460
Lleida , Spain Clay 2.4 19 7.6 381
Gross

- Umstadt , Germany Loam 1.2 11 6.7 665
Nambsheim , France Sandy loam 1.7 11 7.4 451 Average (n= 5) 496 

### IN

- RDT31 Transformation Products

Nambsheim , France Sandy loam 1.7 10 7.4 83 7
Tama , USA S ilty clay loam 1.9 19 5.7 2 ,5 1 7
Lleida , Spain Clay 2.0 17 7.5 628
Gross

- Umstadt , Germany Loam 1.2 11 6.7 1

, 17 7 Sassafras #16 , USA Sandy loam 3.1 8 5.1 68 2 Average (n= 5) 1,168 

### IN

- E8S72 Degradate

Tama , USA S ilty clay loam 2.2 6.6 18 6.1
Lleida , Spain Clay 1.8 7.8 17 11.6
Gross

- Umstadt , Germany Loam 1.1 6.8 12 10.5
Nambsheim , France Sandy loam 1.5 7.8 11 5.0
Sassafras #16 , USA Sandy loam 1.1 5.4 7 5.3 Average (n= 5) 7.7 

### IN

- QPS10 Degradate

Nambsheim , France Sandy loam 1.7 10 7.4 2,309
Tama , USA S ilty clay loam 1.9 19 5.7 14,367
Lleida , Spain Clay 2.0 17 7.5 2,573
Gross

- Umstadt , Germany Loam 1.2 11 6.7 3,372
Sassafras #16 , USA Sandy loam 3.1 8 5.1 1,789 Average (n= 5) 4,882



### Data in Table 3.16 suggest the following:

(1) 

### Adsorption of the transformation product IN

- RAB06 suggests that it is a moderately mobile chemical. Following adsorption, de sorption ranged from 26 to 42% of the adsorbed; (2) 

### Adsorption of the transformation product IN

- RDT31 suggests that it is a slightly mobile chemical. Following adsorption, de sorption levels ranged from 10 to 30% of the adsorbed ; (3) 

### Adsorption of the degradate IN

- E8S72 suggests that it is a mobile chemical. Following adsorption, de sorption levels ranged from 25 to 46% of the adsorbed; and (4) 

### Adsorption of the degradate IN

- QPS10 suggests that it is a slightly mobile chemical. Following adsorption, de sorption levels ranged from 7 to 31% of the adsorbed.

Additionally, adsorption coefficients were determined for other TPs and DEGs by the HPLC method ( Table 3. 17 ).

### 51 23 Table 3.17 Mean adsorption coefficients (K oc 

### ) for selected TPs and DEGs as determined by the HPLC method

TP or DEG Level and Systems Where it Was Observed Mean K oc Mobility Class 

### Transformation Products (TPs)

IN

- RYJ52 ( 2 isomers)

Major aerobic/anaerobic aquatic systems transformation products 1,446 & 1,586 Slightly Mobile
IN

- RSE01 2,600 Slightly Mobile
IN

- S2K66 4,028 Slightly Mobile
IN

- Q7D41 8,611 Slightly Mobile 

### Degradates (DEGs)

IN

- P3X26 A major/unique aqueous photolysis degradate 639 Moderately Mobile
IN

- S2K67 Major anaerobic aquatic systems degradates 902
IN

- QFD61 1,289 Slightly Mobile



### 3. 4. Stressor of Concern

3.4.1 Determination of the Stressor of Concern

Based on the physical/chemical and laboratory and field fate and transport data, o xathiapiprolin is expected to be relatively persistent in important compartments of the environment. The transformation/degradation profile of oxathiapiprolin suggest that biotic and to a lesser extent abiotic processes will affect the chemical causing the formation of many transformation products (TPs) and d egradates (DEGs). Most of these TPs and DEGs are expected to form at low concentrations or decline to low concentrations. However, other TPs and DEGs are expected to forms at higher concentration with few persisting and the rest declining. Due to the ext ensive nature of the degradation profile for this chemical it was necessary to execute full examination of oxathiapiprolin residues resulting from its degradation profile in varied environmental compartments and their toxicit ies.

Two important factors will be considered in selecting the residues of concern for conducting the ecological risk assessment for oxathiapiprolin. These factors are expected exposure intensity/ timing and toxicity of parent and associated residues.

Based on the analysis presented below , parent oxathiapiprolin is considered to be the stressor of concern for the environmental risk assessment

.

3.4.1.1 Exposure

In an agricultural setting, oxathiapiprolin is applied to various crops either to the foliage throughout the growing season or to the soil at or near planting. Therefore, the chemical is expected to reach the soil directly or indirectly by wash

- off with quantities that are expected to vary depending on application method (varied drift) and timing (varied foliage density) . Upon application, only limited quantities of the pesticide are expected to be carried away by drift (to adjacent terrestrial

### 52 and aquatic systems) with the important part being deposited into the soil (targeted or untargeted)

or t arget plants and later a ffected by entering the plant tissues or by wash

- off into the soil. Oxathiapiprolin is a systemic fungicide and moves systemically in the plant xylem (translaminar movement). Therefore environmental distribution of the chemical is e xpected to be as follows:

(1) Limited quantities are expected to be carried away by drift (to adjacent terrestrial and aquatic systems (default values= 13.5% for aerial application and 6.6% for ground application); and

(2) Major quantities will reach plant folia ge and the soil system depending on the type of application (foliar or soil) as follows:

a. The soil system: in soil application major quantities of oxathiapiprolin come directly from application and in foliar application the chemical reaches the soil partly/indirectly from application (quantities depends on foliage density) and additional quantities come indirectly from subsequent foliage wash

- off. Both quantities are expected to be reduced due to plant uptake into the leaf tissue and new plant growth (foliage uptake). Oxathiapiprolin reaching the foliage, from foliar spray, is expected to rapidly penetrate into plant tissues (Oxathiapiprolin is rain

- fast within 30 minutes after spray residues have dried). The “rain

fast” property of the chemical is exp ected to limit quantities of the pesticide that would reach the soil system from wash

- off.

b. Parent entering the plant through foliage is important in determining terrestrial exposure and might affect aquatic exposure to parent and/or its metabolites depending on plant metabolism and agricultural practices dealing with plant residues (removed or l eft on the field). It is noted that this aspect of exposure is not considered in this risk assessment

, resulting in a more conservative approach

.
Hydrolysis, aqueous photolysis, photolysis on soil and anaerobic soil metabolism are not expected to be influ ential in estimating environmental exposure concentrations in various environmental compartments and consequently in exposure to surface and ground waters. It follows that the fate and transport of oxathiapiprolin and its transformation product/degradates in both aerobic soil and aerobic/anaerobic water/sediment systems are the important factors in surface and ground water exposure to oxathiapiprolin and TPs / DEGs residues.

In the aerobic soil system, oxathiapiprolin reaching the soil, by direct/indirect a pplication or wash

off, will be subjected to slow transformation/degradation into relatively high number/low levels of TPs/DEGs. Likewise, oxathiapiprolin parent is expected to reach aquatic systems by drift at application and parent and aerobic soil TPs/D EGs following application by run

- off. All chemicals residues reaching aquatic systems are expected to be subjected to transformation/ degradation. Figure 3. 2 summarizes processes and expected levels of TPs and DEGs. This summary is based on fate and transp ort data presented earlier in this document

.

### 53 4 Figure 3. 2 Processes and levels of transformation products/degradates of oxathiapiprolin in soil and aquatic systems


## (1) A erobic Soil System (90 th 

## perce ntile t 1⁄2 = 161 d ay s )

Slow Aerobic Soil Transformation/Degradation Process es



### (2) W ater/Sediment Systems (90 th



### - ntile t 1⁄2 = 143 /1 21 d ays for Ae robic/anaerobic)

Slow Aerobic /Anaerobic Aquatic Transformation/Degradation Process es

Persistence: persistence is indicate by text : Bold = relatively persistent; Higlighted Gray = Showed no apparent decline and Bold Italic = Showed decline

.



### I n order to assess exposure based on data summarized in Figure 3.1 , a criteria is assumed for choosing the TPs and DEGs of oxathiapiprolin that might be of concern in aquatic systems ( surface/ground water ) . In this process, the following conservative criteria was used:

(1) For surface water: NONE Transformation Products (TPs) Degradates (DEGs)

Formation @ High Level (Max 9

- 14%) Formation @ Low Level (Max 3%) Formation @ High Level (Max 7

- 9%) Formation @ Low Level (Max 4%) Parent from Direct/Indirect Application & Wash

- off

Persisting IN

- RAB06 IN

- RTD31 Declining

None

Persisting IN

- Q7D41 Declining None Declining
IN

- QPS10 Declining None Persisting IN

- E8S72 Persisting IN

- RLD51
IN

- WR791

Transformation Products Degradates

Formation @ High Level Aerobic: Max 9

- 16%
Anaerobic: Max 8

- 33% Formation @ Low Level Aerobic: None Anaerobic: Max 2% Formation @ High Level Aerobic: None Anaerobic: 14

- 20% Parent from Drift and Run

- off

Persisting IN

- Q7D41 IN

- S2K66 Declining
IN

- RSE01
IN

- RYJ52 IN

- RAB06 Persisting None Declining None Declining None Persisting None

Persisting IN

- RYJ52 IN

- S2K66 IN

- Q7D41 Declining
IN

- RSE01 Persisting IN

- RBR89 Declining None Persisting IN

- S2K67 2, 6

- DFBA/ IN

- YY147 Declining IN

- QFD61



### (3) Run

- off: TPs: IN

- RAB06, IN

- RTD31 + DEGs: IN

- E8S72 Aerobic Systems

Anaerobic Systems Formation @ Low Level

in Aerobic /anaerobic systems

### 54 i. Include r esidues that are of relatively high and low exposure concern in two categories :

• The high exposure residues: that is residues observed at maximums of nearly 10% with no decline or no apparent decline in at least one of the soil/aquatic systems ; and

• The low exposure residues: that is residues observed at high levels and declining and those observed at relatively low levels with no decline.

ii. Exclude r esidues that are of relatively very low exposure concern

.

(2) For ground water: un

- degraded parent and residues forming in the aerobic soil system and are expected to be mobile to moderately mobile based on the organic carbon normalized adsorption coefficient (K oc 

### ). Relat ively low and high exposures will be based on relative persistence/mobility of the residue in question.

Based on this criteria and data in Figure 3.1 , the following are suggested arbitrary categories of the residues of concern:

(1) For surface water:

• The high exposure residues:

 TPs: INRTD31

, IN

- Q7D41

, IN

- S2K66 , and IN

- RYJ52 isomers (high level/no decline)

and IN

- RAB06 (high level/no apparent decline); and

 DEGs: IN

- S2K67 and 2, 6

- DFBA/IN

- YY147 (high level/no decline) and IN

- E8S72 and

IN

- QFD61 (high level/no apparent decline).

• The low exposure residues: TPs: IN

- RBR89 (low level/no decline) and IN

- RSE01 (high level/declining) and the DEGs: IN

- QPS10 (high level/declining).

(2) For ground water:

• The high exposure residues: The mobile to moderately mobile degradate IN

- E8S72 and transformation product IN

- RAB06 (K oc 

### = 7 and 496 mL g

- 1 

### ); and

• The low exposure residues: The slightly mobile transformation product IN

- RDT31 and degradate IN

- QPS10 (Koc=1,168 and 4,880 mL g

- 1 

### ).

It is however important to note that although parent is a hardly mobile chemical, its persistence may result in its movement to ground water with time.

In summary, based on exposure, residues that might be of concern are:

### 55 (1) For surface water: un

- degraded Parent + TPs: IN

- RAB06, IN

- RTD31, IN

- Q7D41, IN

S2K66, IN

- RSE01, IN

- RYJ52 (two isomers) and IN

- RBR89 + the DEGs: IN

- E8S72, IN

- S2K67

, IN

- QFD61, IN

- QPS10 and 2,6DFBA/IN

- YY147 ; and (2) For ground water: un

- degraded Parent + TPs: IN

- RAB06 and IN

- RDT31 + DEG: IN

E8S72 and IN

- QPS 10

.
Available information and structures for oxathiapiprolin TPs and DEGs are included in Attachment 1

.

3.4.1.2 Toxicity of TPs and DEGs of Oxathiapiprolin to Aquatic Taxa

There is a robust suite of studies available to characterize the acute toxicity of the various degradation and transformation products of oxathiapiprolin to three aquatic taxa. Tables 3.18, 3.19 and 3. 20 below summarize the available toxicity studies for acute exposure to freshwater fish, acute exposure to freshwater invertebrates, a nd freshwater green algae, respectively. Previous sections characterizing the environmental fate of oxathiapiprolin made the distinction between transformation products (which kept the major backbone structure of oxathiapiprolin and in some cases, added a moiety to the parent structure) from degradates (that lost one or more of the rings of the parent structure). For the sake of simplicity, in this section, all residues that originated from parent oxathiapiprolin will be hereafter referred to as degradate s.

For acute toxicity to the rainbow trout, there are 11 studies available, each testing a different degradate of oxathiapiprolin. For all products with the exception of 3 (IN

- RAB06, IN

- QPS10, and
IN

- E8S72), a single concentration was tested and there w as no mortality or clinical signs of toxicity observed during the test. For IN

- E8S72, nominal concentrations ranging from 4.27

– 100 mg a.i/L (as well as negative and solvent controls) were tested with no observations of mortality or clinical signs of tox icity during the study . Similarly, the study with IN

- RAB06 tested nominal concentrations ranging from 3.13

– 50.0 mg a.i/L (as well as negative and solvent controls) with no observations of mortality or clinical signs of toxicity. In a study with IN

- QPS1 0, fish were exposed to mean measured concentrations ranging from 0.91

– 9.59 mg a.i/L (as well as negative and solvent controls). There was 100% mortality in the highest concentration and observations of altered pigmentation, loss of equilibrium, and rap id operculum movement in 5 of 7 fish at this concentration. All studies are classified as acceptable.

24 Table 3.18

. Summary of acute toxicity data to freshwater fish (rainbow trout

– Oncorhynchus mykiss ) exposed to the degradates of oxathiapiprolin Degradation / Transformation Product Exposure System Test Substance

(Purity) LC 50 (95% CI; slope) 1 Acute Toxicity Classification 2 Study Classification (MRID)
Parent oxathiapiprolin Static TGAI (95.8%) 96

- hr LC 50 : >0.69 mg/L (N/A; N/A) Highly toxic Acceptable (49011289)

IN

- RYJ52 Static TGAI (67%) 96

- hr LC 50 : > 13.8 mg/L (N/A; N/A ) Slightly toxic Acceptable (49011292)

IN

- S2K66 Static TGAI (88.7%) 96

- hr LC 50 : >7.48 mg/L (N/A; N/A) Moderately toxic Acceptable (49011293)

### 56 Degradation / Transformation Product Exposure System Test Substance

(Purity) LC 50 (95% CI; slope) 1 Acute Toxicity Classification 2 Study Classification (MRID)

IN

- Q7D41 Static

- renewal TGAI (90.3%) 96

- hr LC 50 : >0.18 mg/L (N/A; N/A) Highly toxic Acceptable (49011294)

IN

- RSE01 Static

- renewal TGAI (83.2%) 96

- hr LC 50 : >9.84 mg/L (N/A; N/A) Moderately toxic Acceptable (49011295)

IN

- P3X26 Static TGAI (93.8%) 96

- hr LC 50 : >67.7 mg/L (N/A; N/A) Slightly toxic Acceptable (49011296)

IN

- S2K67 Static TGAI (92.7%) 96

- hr LC 50 : >82.5 mg/L (N/A; N/A) Slightly toxic Acceptable (49011297)

IN

- QFD61 Static TGAI (92.7%) 96

- hr LC 50 : >7.38 mg/L (N/A; N/A) Moderately toxic Acceptable (49011298)

IN

- RAB06 Static TGAI (97.0%) 96

- hr LC 50 : >49.7 mg/L (N/A; N/A) Slightly toxic Acceptable (49011298)

IN

- QPS10 Static TGAI (94.8%) 96

- hr LC 50 : 6.54 mg/L (5.59

– 7.65; N/A) Slightly toxic Acceptable (49011301)

IN

- E8S72 Static TGAI (99.1%) 96

- hr LC 50 : >102 mg/L (N/A; N/A) Practically non

toxic Acceptable (49011302)

IN

- RDT31 Static TGAI (93.6%) 96

- hr LC 50 : >11.6 mg/L (N/A; N/A) Slightly toxic Acceptable (49011303)
LC 50 = Lethal concentration to 50% of the population, CI = confidence intervals, N/A = not applicable

1 Based on mean measured concentrations in terms of active ingredient

2 A l thou g h t h e ac u te t o x icity c la s s i f ic a t io n for some studies is “ slightly, moderately, and highly toxic ,” some st ud ies d i d n o t e l i c it a 50 % m o rtali t y r e s pon se u p to t h e l i mit o f s o l ub i l i t y (as indicated by a non

- definitive LC 50 ).



### For acute toxicity to Daphnia magna , there are 11 studies available, each testing a different degradate of oxathiapiprolin. For all but 5 products (IN

- S2K66, IN

- S2K67, IN

- QPS10, IN

- E8S72 and IN

- QFD61), a single concentration was tested and there was no mortality or clinical signs of toxicity observed during the test. For IN

- E8S72, a single nominal concentrati on of 100 mg a.i/L (as well as negative and solvent controls) was tested and there was one morality observed out of 20 organisms. For IN

- S2K66, mean measured concentrations ranged from 0.017

– 4.27 mg a.i/L (8 concentrations total as well as negative and solvent controls). The percent mortality for each of the 8 concentrations starting with lowest were 0, 5, 20, 25, 45, 70, 80, and 100%, respectively. For
IN

- S2K67, there were 7 mean measured concentrations ranging from 0.72

– 82.6 mg a.i/L (as well

as ne gative and solvent controls). The percent mortality for each of the 7 concentrations was 0, 10, 10, 15, 20, 30, and 60%, respectively. For IN

- QPS 10 , there were 5 mean measured concentrations ranging from 2.27

– 36.3 mg a.i/L (as well as negative and solv ent controls). The percent mortality for each of the 5 concentrations was 0, 0, 15, 65, and 100%, respectively. Finally, for IN

- QFD61, there were 7 mean measured concentrations ranging from 0.067

– 7.56 mg a.i/L (as well as negative and solvent controls) . The percent mortality for each of the 7 concentrations was 0, 0, 0, 5, 5, 30, and 60%, respectively. There were no clinical signs of toxicity observed during any study and all studies were classified as acceptable.

### 57 25 Table 3. 19

. Summary of acute toxicity data to freshwater invertebrates (Water flea

– Daphnia

magna ) exposed to the degradates of oxathiapiprolin Degradation / Transformation Product Exposure System Test Substance

(Purity) LC 50 (95% CI; slope) 1 Acute Toxicity Classification 2 Study Classification (MRID)

Parent oxathiapiprolin Static TGAI (95.8%) 48

- hr EC 50 : >0.56 mg/L (N/A; N/A) Highly toxic Acceptable (49011347)

IN

- RAB06 Static TGAI (97.0%) 48

- hr EC 50 : >95.3 mg/L (N/A; N/A) Slightly toxic Acceptable (49011317)

IN

- RDT31 Static TGAI (93.6%) 48

- hr EC 50 : >10.5 mg/L (N/A; N/A) Slightly toxic Acceptable (49011318)

IN

- QPS10 Static TGAI (94.8%) 48

- hr EC 50 : 14.7 mg/L (12.2

– 17.8; 5.57) Slightly toxic Acceptable (49011319)

IN

- E8S72 Static TGAI (99.1%) 48

- hr EC 50 : >100 mg/L (N/A; N/A) Practically

non

- toxic Acceptable (49011320)

IN

- RYJ52 Static TGAI (67%) 48

- hr EC 50 : > 16.2 mg/L (N/A; N/A ) Slightly toxic Acceptable (49011321)

IN

- S2K66 Static TGAI (88.7%) 48

- hr EC 50 : 0.42 mg/L (N/A; N/A) Highly toxic Acceptable (49011322)

IN

- Q7D41 Static

renewal TGAI (90.3%) 48

- hr EC 50 : >0.15 mg/L (N/A; N/A) Highly toxic Acceptable (49011323)

IN

- RSE01 Static TGAI (83.2%) 48

- hr EC 50 : >10.2 mg/L (N/A; N/A) Slightly toxic Acceptable (49011324)

IN

- P3X26 Static TGAI (93.8%) 48

- hr EC 50 : >67.7 mg/L (N/A; N/A) Slightly toxic Acceptable (49011325)

IN

- S2K67 Static TGAI (92.7%) 48

- hr EC 50 : 59.2 mg/L (32.3

- 177; 1.11) Slightly toxic Acceptable (49011326)

IN

- QFD61 Static TGAI (92.7%) 48

- hr EC 50 : 5.14 mg/L (3.74

– 8.48; 2.49) Moderately toxic Acceptable (49011327)
EC 50 = Effect (immobilization) concentration to 50% of the population, CI = confidence intervals, N/A = not applicable

1 Based on mean measured concentrations in terms of active ingredient 3Although the acute to xicity classification for some studies is “slightly, moderately, and highly toxic,” some studies did not elicit a 50% mortality response up to the limit of solubility (as indicated by a non

- definitive EC 50 ).



### There are 11 studies available to characterize the toxicity of the degradates of oxathiapiprolin to the freshwater green algae Pseudokirchneriella subcapitata. For 5 products (IN

- RYJ52, IN

RAB06, IN

- E8S72 and IN

- Q7D41, and IN

- P3X26), a single concentration was tested which did not result in 50% inhibition or a significant reduction in any endpoint as compared to the negative control. In a study with IN

- QFD61, algal cultures were exposed to mean measured concentrations ranging from 0.72

– 7.53 mg a.i/L (as well as nega tive and solvent controls). There was no concentration that caused a 50% inhibition from the level of the negative control but significant (p<0.05) reductions in cell density yield and mean growth rate were indicated at the 1.29 mg a.i/L

treatment concent ration. The EC 50 

### , NOAEC, and LOAEC were therefore determined to be >7.53, 0.72, and 1.29 mg a.i/L, respectively.

A study with IN

- QPS10 exposed algal cultures to mean measured concentrations ranging from 0.08

– 2.74 mg a.i/L (as well as negative and sol vent controls). The top two treatment concentrations (1.14 and 2.74 mg a.i/L) determined percent inhibition levels of greater than 70 and

### 58 90% for the two concentrations, respectively. The EC 50 

### , NOAEC, and LOAEC were therefore determined to be 0.81, 0.47, and 2.74 mg a.i/L. In a study with IN

- RDT31, mean measured concentrations ranged from 1.07

– 11.4 mg a.i/L (as well as negative and solvent controls). There was no concentration that elicited a 50% or greater inhibition response as compared to the negat ive control. There were significant reductions (p<0.05) in cell density, growth rate, and area under the curve at all treatment concentrations (percent reductions ranged from 12

– 35%) and therefore a definitive NOAEC was not achieved. EFED policy in th is scenario, is to use the EC 05 

### for risk estimation to listed species. The EC 50 

### , EC 05 

### , and LOAEC were determined to be >11.4, 0.26, and 1.07 mg a.i/L, respectively. A study with the degradate IN

- RSE01 exposed algal cultures to mean measured concentration s ranging from 0.031

– 10.1 mg a.i/L (as well as negative and solvent controls). While there were no concentrations that elected a 50% inhibition response or greater as compared to the negative control, there were significant reductions (p<0.05) in area un der the

curve determined at all treatment concentration and therefore a definitive NOAEC was not achieved. The EC 50 

### , EC 05 

### , and LOAEC were determined to be >10.8, 0.011, and 0.031 mg a.i/L, respectively. In a study with IN

- S2K66, mean measured concentrati ons ranged from 4.27

– 7.56 mg a.i/L (as well as negative and solvent controls). There were no concentrations that resulted in a 50% or greater inhibition as compared to the negative control. There were significant reductions (percent reductions ranged f rom 11

- 29%) (p<0.05) for all endpoints assessed at all treatment concentrations and therefore a definitive NOAEC was not achieved. The EC 50, 

### EC 05 

### , and LOAEC were determined to be >7.56, 3.53, and 4.27 mg a.i/L, respectively. Finally, in a study with IN

S 2K67, algal cultures were exposed to mean measured concentrations ranging from 0.28

– 83.5 mg a.i/L (as well as negative and solvent controls). There were no concentrations that resulted in a 50% or greater inhibition as compared to the negative control. There were significant reductions (p<0.05) for all endpoints assessed at all treatment concentrations and therefore a definitive NOAEC was not achieved (percent reductions ranged from 14

– 48% for area under the curve)

. The EC 50, 

### EC 05 

### , and LOAEC were det ermined to be >83.5, 0.008, and 0.28 mg a.i/L, respectively. All studies were classified as acceptable.

26 Table 3.20

. Summary of acute toxicity data to freshwater green algae ( Pseudokirchneriella subcapitata ) exposed to the degradates of oxathiapiprolin

Species Exposure

system Test Substance

(Purity) Endpoint 1,2 Variables Affected Study Classification (MRID)

Parent oxathiapiprolin Static TGAI (98.9%) 72

- hr EC 50 : >0.14 mg/L (N/A, N/A) 72

- hr NOAEC: 0.14 mg/L 72

- hr LOAEC: > 0.14 mg/L None Acceptable (49011332)

IN

- RYJ52 Static TGAI (67%) 72

- hr EC 50 : >15.3 mg/L (N/A, N/A) 72

- hr NOAEC: 0.05 mg/L
72

- hr LOAEC: >0.05 mg/L None Acceptable (49011336)

IN

- S2K66 Static TGAI (88.7%) 72

- hr EC 50 : 9.21 mg/L (8.29

– 10.2) 72

- hr EC 05 : 3.53 mg/L 72

- hr LOAEC: 4.27 mg/L Area under the curve Acceptable (49011337)

### 59 Species Exposure

system Test Substance

(Purity) Endpoint 1,2 Variables Affected Study Classification (MRID)

IN

- S2K67 Static TGAI (92.7%) 72

- hr EC 50 : >83.5 mg/L (N/A, N/A) 72

- hr EC 05 : 0.008 mg/L 72

- hr LOAEC: 0.28 mg/L Area under the curve Acceptable (49011338)

IN

- QFD61 Static TGAI (92.7%) 72

- hr EC 50 : >7.53 mg/L (N/A, N/A) 72

- hr NOAEC: 0.72 mg/L
72

- hr LOAEC: 1.29 mg/L Cell density, growth rate Acceptable (49011339)

IN

- RAB06 Static TGAI (97.0%) 72

- hr EC 50 : >96.9 mg/L (N/A, N/A) 72

- hr NOAEC: 96.9 mg/L
72

- hr LOAEC: >96.9 mg/L None Acceptable (49011340)

IN

- RDT31 Static TGAI (93.6%) 72

- hr EC 50 : >11.4 mg/L (N/A, N/A) 72

- hr EC 05 : 0.24 mg/L 72

- hr LOAEC: 1.07 mg/L Area under the curve Acceptable (49011341)

IN

- QPS10 Static TGAI (94.8%) 72

- hr EC 50 : 0.81 mg/L (0.70

– 0.95) 72

- hr NOAEC: 0.48 mg/L
72

- hr LOAEC: 1.14 mg/L Cell density, area under the curve Acceptable (49011342)

IN

- E8S72 Static TGAI (99.1%) 72

- hr EC 50 : >102 mg/L (N/A, N/A) 72

- hr NOAEC: 102 mg/L
72

- hr LOAEC: >102 mg/L None Acceptable (49011343)

IN

- Q7D41 Static

renewal TGAI (90.3%) 72

- hr EC 50 : >0.21 mg/L (N/A, N/A) 72

- hr NOAEC: 0.21 mg/L 72

- hr LOAEC: >0.21 mg/L None Acceptable (49011344)

IN

- RSE01 Static TGAI (83.2%) 72

- hr EC 50 : >10.1 mg/L (N/A, N/A) 72

- hr EC 05 : 0.011 mg/L 72

- hr LOAEC: 0.031 mg/L Area under the curve Acceptable (49011345)

IN

- P3X26 Static TGAI (93.8%) 72

- hr EC 50 : >66.4 mg/L (N/A, N/A) 72

- hr NOAEC: 66.4 mg/L 72

- hr LOAEC: >66.4 mg/L None Acceptable (49011346)

NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration EC 50 = Effect concentration to 50% of the population, CI = confidence intervals, N/A = not applicable

1 Based on mean measured concentrations in terms of active ingredient

2 When a definitive NOAEC is not achieved, EFED policy is to use the EC 05 for use in risk estimation to listed species of aquatic plants.



### 3.4.1.3 R ationale for selection of the stressor of concern

As indicated above, only certain degradates were within an order of magnitude or similar toxicity of that of parent oxathiapiprolin. These degradates will be discussed hereunder for each taxa

.

### 60 For freshwater fish, the sole degradate within an order of magnitude of the toxicity of parent oxathiapiprolin was IN

- Q7D41. It is noted that relative toxicities cannot be accurately compared as thes e endpoints are non

- definitive but rather in terms of highest concentration tested. Environmental fate data of IN

- Q7D41 shows the degradate forming at a maximum rate of 12% of the applied residues ( i.e. marginally above t he threshold by which residues are considered to be major) in the aerobic aquatic metabolism pathway. It follows that this degradate is expected to form only from drift reaching aquatic systems which make it less significant in terms of exposure. Furthermore, t his degradate was not examined in terrestrial field dissipation studies because it is a minor degradate in the laboratory aerobic soil study ( m ax imum formation rate of 1

- 3%) and is not expected to form at a high rate in a field setting. Finally, this deg radate has an estimated solubility of 0.007 mg/L (EPISuite v.4. 1 ), which is approximately 2 orders of magnitude lower than that of parent oxathiapiprolin. In the available acute toxicity study with freshwater fish, the sole mean measured concentration of IN

- Q7D41 was 0.18 mg a.i/L, for which there was no mortality observed. Therefore, IN

- Q7D41 is not expected to be of ecotoxicological concern to fish.

In the case of freshwater invertebrates, there are two degradates that are within an order of magnitude of the toxicity of parent oxathiapiprolin ; IN

- S2K66 and IN

- Q7D41

. For IN

- S2K66, the toxicity was determined to be approximately 1.5 fold more toxic than parent. For IN

- Q7D41, its toxicity cannot be compared to the parent endpoint without uncertainty as th e study with IN

Q7D41 yielded a non

- definitive endpoint. All other degradates were at least one order of magnitude less toxic than parent oxathiapiprolin (the aforementioned uncertainties inherent in comparing non

- definitive endpoints also applying here t o certain degradates). The degradate IN

S2K66 forms primarily via the aerobic and anaerobic aquatic metabolism pathways where maximum formation rates ranged from 2

- 9% and 10

- 13%, of the applied residues , respectively (just over the threshold to be conside red major). EpiSuite (v.4. 1 ) estimates the solubility of this degradate to be 0.009 mg/L, which is approximately two orders of magnitude less soluble than parent oxathiapiprolin. In the available toxicity study with freshwater invertebrates, mean

measure d concentrations for this degradate ranged from 0.017 to 4.27 mg a.i/L. There was no mortality observed in the lowest concentration (0.017 mg a.i/L ) which is above the estimated solubility of this degradate. Therefore, IN

- S2K66 is not expected to be of e cotoxicological concern for freshwater invertebrates.

The same discussion on exposure for IN

- Q7D41 (discussed above for freshwater fish) applies for freshwater invertebrates as well. In the available toxicity study for IN

- Q7D41 to freshwater invertebrate s, the sole mean measured concentration was 0.15 mg a.i/L, which is approximately 2 orders of magnitude higher than the estimated solubility for this degradate, for which there was no mortality observed. Therefore, IN

- Q7D41 is not expected to be of ecotox icological concern for freshwater invertebrates.

For freshwater green algae, there were 3 degradates that yielded endpoints within an order of magnitude of parent oxathiapiprolin (although relative toxicity cannot be compared without uncertainty due to the non

- definitive endpoint of the parent compound). The transformation product IN

- S2K66 was previously discussed regarding its formation rates. The available toxicity study exposes freshwater green algae cultures to IN

- S2K66 concentrations ranging from 4.27

–

### 61 7.56 mg a.i/L. As discussed previously, the estimated solubility of this degradate is 0.009 mg/L. At the lowest treatment concentration of this study, mean measured 4.27 mg a.i/L, percent reductions from control for various endpoints ranged from 2 .2

– 10.6%, therefore, not achieving a 25% effect as compared to the negative control. As these effects occurred at a concentration roughly 3 orders of magnitude above the solubility limit of IN

- S2K66, this degradate is not expected to be of ecotoxicologi cal concern to aquatic plants.

While the transformation product IN

- Q7D41 showed a non

- definitive endpoint within an order of magnitude of parent, the previous discussion of this degradate indicates a solubility 2 orders of magnitude lower than parent and the available toxicity study shows a stimulatory effect of the endpoints at the sole mean measured concentration of 0.21 mg/L. Therefore, IN

- Q7D41 is not expected to be of ecotoxicological concern to aquatic pla nts.

The degradate IN

- QPS10 is not a major degradate as it was shown to form only in the aerobic soil at maximum rates of 3

- 9% followed by a decline

. Therefore, IN

- QPS10 is not expected to be of ecotoxicological concern to aquatic plants.

It is noted tha t the environmental fate data indicate the formation of another maj or degradate, 2, 6

- DFBA/IN

- YY 147 (Max imum formation rates of 10

- 18% with no decline in anaerobic aquatic study) with no ecotoxicity data available. Therefore, ECOSAR (v1.1) was used to est imate the toxicity using quantitative structure activity relationships (QSARs). ECOSAR predicts toxicity using a regression of the log K OW 

### and measured toxicity endpoints for a particular species and chemical class. The sole ECOSAR class that returned re sults for this degradate was the neutral organics

- acid class. As shown below in Table 3. 21 , this degradate is several orders of magnitude less toxic than parent oxathiapiprolin on both an acute and chronic basis for which there are toxicity estimates avai lable. Therefore, 2, 6

- DFBA/IN

- YY147 is not expected to be of ecotoxicological concern to aquatic taxa.

27 Table 3.21

. ECOSAR Estimates of the oxathiapiprolin degradate 2, 6

- DFBA/IN

- YY147

Compound (Chemical Class) B Estimated Toxicity Value (mg/L)
96

- hr FW fish EC50 48

- hr FW Daphnid LC50 Fish NOAEC Daphnid NOAEC 96

- hr EC50 Green Algae Oxathiapiprolin (registrant submitted studies) >0.69 0.63 0.23 0.75 >0.14

2,6

- DFBA/IN

- YY471 (Neutral organics

- acid ECOSAR class) 7150 1 3762 1 639 297 2045

1 Indicates chemical may not be soluble enough at this concentration to elicit an effect



### As stated previously, based on this analysis, parent oxathiapiprolin is considered to be the stressor of concern for the environmental risk assessment

.

### 62 3.4.2 Aquatic Exposure Assessment

3.4.2.1. Inputs Used for Modeling

The first set of input parameters needed for modeling is labeled application parameters for various use patterns and representative scenarios

. S uggested labeled application parameters / representative scenarios are summarized in Table 3.2 2 for foliar application and Table 3.23

28 Table 3.22

. S ummary of modeled foliar application parameters for oxathiapiprolin (refer to abbreviations, below)

Crop Group Crop(s) Scenario MSR MNA MYR MAI FADs

Brassica Vegies Cabbage FLcabbageSTD

0.0311 2+2 0.1245 5

The f irst application date was assumed to be 21 days after plant emergence. The batch run feature of the SWCC was used with an application window throughout the growing season at 5

- day step. The minimum application interval stated in the label was used between each two applications and two times the interval was used after each two application for the required period to apply another type of fungicide for resistan t management Cole crops CAColeCropRLF_V2

Bulb Vegies Onion CAonion_WirrigSTD

0.0311 2+2 0.1245 5 GAOnion_WirrigSTD

WAonionsNMC
Garlic CAGarlicRLF_V3

Cucurbit Vegies Melons CAMelonsRLF

0.0311 2+2 0.1245 3 STXmelonNMC
MImelonStd
MOmelonStd
NJmelonStd
Cucumber FLcucumberSTD

Fruiting Vegies Peppers FLpeppersSTD

0.0311 2+2 0.1245 5 Tomato CAtomato_WirrigSTD FLtomatoSTD_V2
PAtomatoSTD

All PAvegetableNMC STXvegetableNMC Ginseng Ginseng MNsugarbeetSTD 0.2503 2 0.5006 14

Leafy Vegies Lettuce CAlettuceSTD

0.0311 2+2 0.1245 3 Others CARowCropRLF_V2
Peas Snap bean ORsnbeansSTD 0.0311 2+2 0.1245 5

Tuberous/ Corm vegetable s Potatoes CAPotatoRLF_V2

0.0311 2 0.0622 5 FLpotatoNMC IDNpotato_WirrigSTD 0.026 1 0.026 10 MEpotatoSTD

0.0441 2 0.0882 @ nickle size tubers (+60 d) WApotatoNMC
Sweet Potato NCSweetPotatoSTD

Ornamentals Nurseries CAnurserySTD_V2

0.0417 12 0.5006 5 FLnurserySTD_V2 MInurserySTD_V2 NJnurserySTD_V2 ORnurserySTD_V2 TNnurserySTD_V2

Turf turf CATurfRLF

0.2503 2 0.5006 10 FLturfSTD
PAturfSTD

### 63 Crop Group Crop(s) Scenario MSR MNA MYR MAI FADs

MSR= Maximum single rate (Kg/ha), MNA = Maximum number of applications; MYA = Maximum y early application (Kg/ha/year); and the FAD (s)= First application date(s)



### 29 Table 3.2 3

. S ummary of modeled soil application parameters for oxathiapiprolin (refer to abbreviations, below; All 7

- d intervals between applications).

Crop Group Crop(s) Scenario MSR MNA MYR FADs

Cucurbit Vegies Melons CAMelonsRLF

0.0311

3 0.5006

A total of three applications:
1 st near planting
2 nd after 7

- days 3 rd after 14 days (7d x 2 for resistant management) STXmelonNMC
MImelonStd

0.2503 MOmelonStd
NJmelonStd

0.2192 Cucumber FLcucumberSTD

Fruiting Vegies Peppers FLpeppersSTD

0.0311

3 0.5006 Tomato CAtomato_WirrigSTD

FLtomatoSTD_V2 0.2503 PAtomatoSTD 0.2192

All PAvegetableNMC STXvegetableNMC

Leafy Vegies Lettuce CAlettuceSTD 0.0623

3 0.5006 0.2503 Others CARowCropRLF_V2 0.1880

Tobacco Tobacco NCtobaccoSTD 0.0623

3 0.5006 0.2503
0.1880

Ornamentals Nurseries Drench CAnurserySTD_V2

0.0417 12 0.5006 1 st application near planting FLnurserySTD_V2 MInurserySTD_V2 NJnurserySTD_V2 ORnurserySTD_V2 TNnurserySTD_V2

Ornamentals Nurseries Soil CAnurserySTD_V2

0.2503 2 0.5006 1 st application near planting FLnurserySTD_V2 MInurserySTD_V2 NJnurserySTD_V2 ORnurserySTD_V2 TNnurserySTD_V2
PAturfSTD

MSR= Maximum single rate (Kg/ha), MNA = Maximum number of applications; MY R = Maximum y early rate (Kg/ha/year); and the FAD (s)= First application date(s)



### The second set of input parameters needed for modeling is the fate and transport characteristics of the chemicals being modeled. These parameters are summarized for oxathiapiprolin in 31 Table 3 .24

.

### 64 30 31 

### Table 3 .24

. Summary of the SWCC input parameters for oxathiapiprolin

Application rate (Kg/ha) Refer Tables 1

- 2 Application Efficiency and Drift as per Guidance

Adsorption coefficient Koc (L Kg

- 1 ) 12,810 Average for 6 soils (MRID s 49011270 and 49011271 )

Water column metabolism half

- life (days) 143 @ 20 o C The 90th percentile t1⁄2 from two values/systems (MRID 490112

- 79)

Benthic sediment half

- life (days) 121 @ 20 o C The 90th percentile t1⁄2 from four values/systems (MRID 490112

- 80/81) Aqueous photolysis t1⁄2 (days) 31 MRID 490111

- 22 Photolysis reference latitude ( o ) 40
Hydrolysis half

- life @ pH 7 (days) (0) Stable MRID 490111

- 21

Soil half

- life (days) 1 161 @ 25 o C The 90th percentile t1⁄2 from six values for parent (MRIDs 490111

- 55 & 490112

- 50/51/52) Molecular Weight (M wt. in gram mole

- 1) 539.53 Registrant Data Vapor pressure (VP in torr) 8.56 x10

- 9 Registrant Data Henry’s Law Constant (unitless) 1.35 x10

- 6 Calculated Solubility (mg/L or ppm) 0.1844 Registrant Data

Spray drift (Efficiency) for A e rial 12.5% (95%) For all crops, except those stated in the following

two rows Spray drift (Efficiency) for Ground 6.2% (99%) Turf & Ornamentals



### 3.4.2.2. Modeling Results

Exposure surface/pore waters and sediment EECs for oxathiapiprolin were modeled for foliar, soil and seed applications. However, only the application method resulting in the highest exposure EECs for each crop/crop group are reported herein in Table 3.25

.

32 Table 3.25

. Summary of the maximum ECO EECs resulting from oxathiapiprolin use (all maximums were for soil application for crops for which application can be either to foliage or to soil; only foliar application is suggested for Brassica/bulb vegetables; Ginseng & turf)

Crop Group Crop(s) Scenario Surface Water Pore Water Sediment (Sed.)
ECO EECs (ppb) ug/Kg dry Sed.

Peak 21

- day 60

- day Peak 21

- day Peak 21

- day

Brassica V egetables Cabbage FLcabbageSTD 0.3620 0.1490 0.1020 0.0623 0.0616 32 32 Cole crops CAColeCropRLF_V2 0.3600 0.1730 0.1290 0.0935 0.0927 48 48

Bulb V egetables Onion CAonion_WirrigSTD 0.2710 0.1220 0.0797 0.0469 0.0463 24 24 GAOnion_WirrigSTD 0.3490 0.1480 0.1100 0.0745 0.0735 38 38
WAonionsNMC 0.3750 0.1480 0.1110 0.0787 0.0780 40 40
Garlic CAGarlicRLF_V3 0.3200 0.1420 0.1010 0.0604 0.0597 31 31

Cucurbit V egetables Melons CAMelonsRLF 0.8190 0.2950 0.1820 0.1130 0.1100 58 56
STXmelonNMC 2.3200 0.7670 0.5130 0.3710 0.3560 190 183
MImelonStd 0.9090 0.3600 0.2370 0.1560 0.1520 80 78
MOmelonStd 1.7600 0.5500 0.3780 0.2550 0.2490 131 128
NJmelonStd 1.2800 0.4480 0.3190 0.2210 0.2160 113 111
Cucumber FLcucumberSTD 1.7100 0.5550 0.3790 0.2340 0.2330 120 120

### 65 Crop Group Crop(s) Scenario Surface Water Pore Water Sediment (Sed.)
ECO EECs (ppb) ug/Kg dry Sed.

Peak 21

- day 60

- day Peak 21

- day Peak 21

- day

Fruiting V egetables Peppers FLpeppersSTD 1.9100 0.6470 0.4080 0.2450 0.2410 126 124

Tomato CAtomato_WirrigSTD 0.8500 0.3000 0.1840 0.1100 0.1090 56 56 FLtomatoSTD_V2 1.6000 0.5020 0.3640 0.2320 0.2260 119 116
PAtomatoSTD 3.0700 1.0000 0.7310 0.5600 0.5490 287 282

All PAvegetableNMC 1 4.2000 1.3800 0.9340 0.7410 0.7240 380 371 STXvegetableNMC 1.7800 0.5730 0.4160 0.2890 0.2980 148 153 Ginseng Ginseng MNsugarbeetSTD 1.8500 0.7180 0.4560 0.3130 0.3060 161 157 Leafy V egetables Lettuce CAlettuceSTD 1.4700 0.5410 0.3680 0.2610 0.2580 134 132
Others CARowCropRLF_V2 1.0600 0.5280 0.3540 0.1970 0.1960 101 101
Peas Snap bean ORsnbeansSTD 0.4950 0.2290 0.1930 0.1560 0.1550 80 80
Tobacco Tobacco NCtobaccoSTD 1.4800 0.5040 0.3230 0.2050 0.2040 105 105

Tuberous/ Corm V egetables Potatoes CAPotatoRLF_V2 0.3760 0.1470 0.1000 0.0637 0.0624 33 32 FLpotatoNMC 0.6550 0.2680 0.1870 0.1310 0.1280 67 66 IDNpotato_WirrigSTD 0.4070 0.1780 0.1350 0.0942 0.0943 48 48 MEpotatoSTD 1.0100 0.4010 0.3150 0.2750 0.2730 141 140 WApotatoNMC 0.5130 0.2060 0.1590 0.1220 0.1210 63 62

Sweet Potato NCSweetPotatoSTD 1.0200 0.3820 0.2720 0.2070 0.2050 106 105

Sugarbeet Sugarbeet CAsugarbeet_WirrigOP 0.3680 0.1500 0.1040 0.0732 0.0722 38 37 MNsugarbeetSTD 0.4120 0.1840 0.1420 0.1010 0.1000 52 51

Ornamentals Nurseries CAnurserySTD_V2 1.7400 0.5290 0.3300 0.2220 0.2180 114 112 FLnurserySTD_V2 2.6400 0.6930 0.4510 0.2760 0.2730 142 140 MInurserySTD_V2 1.1100 0.5070 0.3540 0.2550 0.2530 131 130 NJnurserySTD_V2 2.0200 0.6380 0.4330 0.3000 0.2930 154 150 ORnurserySTD_V2 0.9940 0.3710 0.2280 0.1480 0.1460 76 75 TNnurserySTD_V2 1.9500 0.6400 0.4100 0.2770 0.2700 142 139

Turf turf CATurfRLF 1.7500 0.6420 0.3730 0.2320 0.2300 119 118
FLturfSTD 1.7300 0.6020 0.3260 0.1840 0.1790 94 92
PAturfSTD 1.8700 0.7190 0.4270 0.2670 0.2640 137 135

1 

### Additional Averages used in the Assessment: All Averages for application to fruiting vegetables / PAvegetableNMC:



### 3.4 .3

. Terrestrial Exposure Assessment

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals, emphasizing a dietary exposure route for uptake of pesticide active ingredients. These exposures are considered as surrogates for terrestrial

- phase amphibians as well as reptiles. For exposure to terrestrial organisms, such as birds and small mammals, pesticides residues on food items are estimated, based on the assumption that organisms are exposed to a single pesticide residue in a given exposure scenario.

### 66 3.4 .3. 1. Terrestrial Modeling for Birds and Mammals

For oxathiapiprolin foliar spray applications to agricultural crops (ground airblast or aerial with the Zorvec TM 

### Enicade TM 

### formulation, and foliar applications of OXATHIAPIPROLIN FHG (oil dispersion formulatio n) to ornamentals, estimation of pesticide concentrations in wildlife food items focuses on quantifying possible dietary ingestion on vegetative matter and insects. As described earlier, the EFED terrestrial exposure model (T

- R EX, version 1.5.2.) is used to estimate

exposures and risks to avian and mammalian species.

For food crops, Zorvec TM 

### Enicade TM 

### label lists ginseng as the highest single application rate as well as the highest maximum annual rate of all crops (0.25 lbs a.i/A single application rate and 0.50 lbs a.i/A maximum annual rate compared to 0.03 lbs a.i/A single application rate and 0.12 l bs a.i/A maximum annual application rate for most of the other proposed uses). Therefore the ginseng use will only be modeled and be protective of all other proposed uses. Additionally, the label also lists soil applications can be made for certain crops that also have folia r uses proposed, although for a given crop it is only permitted to use one regimen or the other ( i.e. foliar spray or soil applied). For the soil applied uses, (cucurbit vegetables, fruiting vegetables, leafy vegetables, and tobacco) a transplant water application is made before planting followed by 2 in furrow soil directed applications. As these use practices cannot be simulated by T

- REX, it was modeled as one application via foliar ground spray at the maximum annual rate. While this approach is conservative for a few reasons such as not taking into account the application interval, lower single application rates, and application method, it will later be showed that even when using this approach, there were no result ant RQs that e xceeded any LOCs. See Section 5 for more information.

For the OXATHIAPIPROLIN FHG oil dispersion formulation proposed use on ornamentals, applications can be made by aerial or ground spray, ground drench to container plants, or ground application to grou nd grown plants/chemigation. The highest single application rates are associated with the ground application to ground grown plants/chemigation and so the input parameters for T

- REX shown below reflect those use practices on the label (Table 3.2 6 ) . This modeled use will be protective of the other application scenarios for ornamentals permitted on the label. For turf uses, applications are made by aerial or ground spray.

33 Table 3.26

. Input parameters for deriving screening

- lev el t errestrial EECs for the p roposed

u ses of o xathiapiprolin.

Uses Represented Single App Rate (lb a.i./A) Max No. of Apps at Max Rate Min. Interval Between Apps (days)

Food crops

– Zorvec TM Enicade TM foliar spray uses Ginseng 0.25 2 14

Food Crops

– Zorvec TM Enicade TM oil dispersion transplant/soil applied (inclusive of all proposed uses) Cucurbit, fruiting, and leafy vegetables and tobacco 0.50 1 N/A Ornamentals and Turf (OXITHIAPIPROLIN FHG

– Oil Dispersion Formulation (Foliar or Soil)

Ornamentals 0.25 2 7 Turf (golf courses only: greens, tees, and fairway) 0.25 2 10 N/A = not applicable

### 67 Differences in exposures between ground and aerial applications cannot be assessed with the
current T

- REX model; exposure and risk estimates from the T

- REX model are considered relevant to both application scenarios. Other u ncertainties in the terrestrial EECs are primarily associated with a lack of data on interception and subsequent dissipation from foliar surfaces. EFED assumes a default 35

- day fol iar dissipation half

- life, based on the work of Willis and McDowell (1987) when data are absent or are insufficient. A further uncertainty with the model is the inability to model systemic chemicals like oxathiapiprolin as T

- REX only simulates residues di rectly on food items. Tables 3.27 and 3. 2 8 provide the screening level dietary and dose

- based EECs, respectively, for terrestrial animals.

As mentioned above s ome use patterns of oxathiapiprolin employ a soil drench method. T

- REX is not able to simulate a soil drench scenario as the resultant EECs and RQs would assume that the entire application rate would be sprayed on terrestrial food items as they are for conventional aerial and ground applic ations. For soil drench, even though the label does not specifically preclude application on foliage, it is expected to take place on the root ball of the crop. Since oxathiapiprolin is systemic, food items are likely to be contaminated with the chemical even if it is not directly applied, when it is translocated across plant tissue. However, the levels or concentrations of oxathiapiprolin in food items are uncertain for the soil drench applications

.

34 Table 3. 27

. Screening

- leve l d ietary

- based EECs (mg/kg di et) as food residues for b irds and

m ammals for the p roposed u ses of o xathiapiprolin Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items ShortGrassTallGrassBroadleafPlantsFruits,pods,seeds,etc.Arthropods
Use(s) 

Ginseng 105 48.3 59.3 6.59 41.3 Cucurbit, fruiting, and leafy vegetables and tobacco 120 55 .0 67.5 7.5 0 47 .0

Ornamentals 112 51.4 63.1 7.01 44.0
Turf (golf courses only: greens, tees, and fairway) 109 50.1 61.4 6.83 42.8
Values are in ppm (mg a.i/kg

- diet).

### 68 35 Table 3. 28

. Screening

- level dose

- based EECs (mg/kg

- bw ) as food residues for b irds and m ammals for the p roposed u ses of

o xathiapiprolin

Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Med Large

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTallGrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.
Arthropods Seeds, grains, etc

. Use(s) 1 

BIRDS

Ginseng 120 55. 1 67. 6 7.51 68.5 31.4 38.5 4.28 30.7 14. 1 17. 3 1.92 47. 1 26.8 12.0 1.67 0.95 0.43
Cucurbit, fruiting, and leafy vegetables; tobacco 137 62.6 76.9 8.54 77.9 35.7 43.8 4.87 34. 9 16.0 19.6 2.18 53.5 30.5 13.7 1.90 1.08 0.48

Ornamentals 128 58.6 71.9 7.99 72.9 33.4 41.0 4.56 32.6 15.0 18. 4 2.04 50. 1 28. 6 12.8 1.78 1.01 0.45

Turf 124 57.0 70.0 7.77 70.9 32.5 39.9 4.43 31.8 14. 6 17. 9 1.98 48.7 27. 8 12.4 1.73 0.99 0.44

MAMMALS

Ginseng 101 46. 1 56. 6 6.28 69.5 31.9 39. 1 4.34 16.1 7.39 9.06 1.01 39.39 27.2 6.31 1.40 0.97 0.22
Cucurbit, fruiting, and leafy vegetables; tobacco 114 52.4 64.4 7.15 79.1 36.2 44.5 4.94 18.3 8.40 10.3 1.15 44.81 31.0 7.18 1.59 1.10 0.25

Ornamentals 107 49.0 60.2 6.69 74.0 33.9 41.6 4.62 17. 2 7.86 9.65 1.07 41.91 29.0 6.72 1.49 1.03 0.24

Turf 104 47.7 58.6 6.51 72.0 33.0 40. 5 4.50 16. 7 7.65 9.39 1.04 40.79 28.1 2 6.54 1.45 1.00 0.23

### 69 3.4 .3.2. Non

- Target Plant Exposure Assessment

Tier II seedling emergence and vegetative vigor toxicity tests did not establish EC estimates, i.e

., the EC 25 

### values were higher than the highest treatment rate tested, for oxathiapiprolin . Specifically, no detrimental effects ≥25% were observed for any test species at rates up to 0.52 and 0.56 lb s a.i/A for seedling emergence and vegetative vigor tests, respecti vely (MRID 49011398 and 49011399, respectively ) . These application rates approximately 2.2 X the maximum single application rate of 0. 25 lb s a.i/A). Furthermore, NOAEC values for terrestrial plants also exceeded the maximum single application rate of oxat hiapiprolin tested. Therefore, no exposure modeling was conducted for terrestrial plants since the non

- listed and listed species LOC of 1.0 could not be exceeded

3.4.3.3. Tier I Exposure Estimates for Honey Bees

As discussed in the EPA guidance for assessing pes ticide risks to honey bees 10 

### , the Tier I method of the risk assessment framework for honey bees is intended to generate “reasonably conservative” estimates of pesticide exposure where reliable values ( i.e. residues values from pollen and nectar) are not ava ilable. Exposure estimates from foliar applications are derived using the application rate assessed for both contact and oral exposures to adult honey bees, and when data are available, to honey bee larvae. For foliar applications of dietary exposure, it is assumed that pesticide residues on tall grass (from the Kenaga nomogram in T

- REX), are suitable surrogates for residues of pollen and nectar of flowers that are directly sprayed. For soil applications, pesticide concentrations in pollen and nectar are assumed to be consistent with chemical concentrations in the xylem of barley (calculated using the Briggs’ model). The estimates used to derive these exposure concentrations are presented in Table 3.2 9 below and the

exposure estimates to be used in ri sk estimation are presented in Table 3. 30

.

36 Table 3.2 9

. Summary of the derivation of contact and dietary exposures used for foliar applications and soil treatments of oxathiapiprolin for Tier I risk assessment to honey bees. Measurement Endpoint Exposure Route Exposure Estimate 1 Foliar applications
Indiv i dual survival (adults) Contact AR * 2.7 μg a.i/bee Individual survival (adults) Diet AR* (110 μg a.i/g) * (0.292 g/day) Soil applications Individual survival (adults) Diet (Briggs EEC) * (0.292 g/day)

AR = application rate in lbs a.i/A

1 Based no food consumption rates for adult worker bees and concentrations in pollen and nectar.

10 Available online at: http://www2.epa.gov/sites/produc tion/files/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf

### 70 37 Table 3.30

. Exposure estimates for contact and dietary exposures for adult honey bees resulting from foliar and soil applications of oxathiapiprolin.

Foliar applied Life stage Exposure Type Dose (μg a.i/bee per 1 lb a.i/A) 1 Oxathiapiprolin Dose for Maximum Application Rate ( μg a.i/bee per 0.25 lb a.i/A)

Adult Diet (nectar and pollen) 32 8.0

Adult Direct contact 2.7 0.68

Soil applied Life Stage Exposure Type Max annual application rate (lbs a.i/A) Briggs estimate 2 Briggs EEC 3

Adult Diet 0.5 0.019 0.006 N/A = not applicable , acute risk LOC = 0.4

1 Source: USEPA 2014 “Guidance for Assessing Pesticide Risks to Bees.”

2 Der i ved from Briggs Model approach using oxathiapiprolin Log K OW of 3.6 and K OC of 12810 L/kg)

3 Briggs estimate * 0.29 (adult bee nectar and pollen consumption rate in g/day)



### 3.4 .3.4 . Terrestrial Organism Exposure in Residues on Aquatic Food Items (KABAM)

The KABAM model (K OW 

### (based) Aquatic BioAccumulation Model) version 1.0 was used to evaluate the potential exposure and risk of direct effects to birds and mammals via bioaccumulation and biomagnification in aquatic food webs. KABAM is used to estimate potential bioaccumulation of hydrophobic organic pesticides in freshwater aquatic ecosystems and risks to mammals and birds consuming aqu atic organisms which have bioaccumulated these pesticides. The bioaccumulation portion of KABAM is based upon work by Arnot and Gobas (2004) who parameterized a bioaccumulation model based on PCBs and some pesticides ( e.g ., lindane, DDT) in freshwater aqu atic ecosystems (Arnot and Gobas, 2004) . KABAM relies on a chemical's octanol

- water partition coefficient (K OW 

### ) to estimate uptake and elimination constants through respiration and diet of organisms in different trophic levels. Pesticide tissue residues are calculated for different levels of an aquatic food web. The model then uses pesticide tissue concentrations in aquatic animals to estimate dose

- and dietary

- based exposures and associated risks to mammals and birds (surrogate for amphibians and reptil es) consuming aquatic organisms. Seven different trophic levels including phytoplankton, zooplankton, benthic invertebrates, filter feeders, small

- sized (juvenile) forage fish, medium

- sized forage fish, and larger piscivorous fish, are used to represent a n aquatic food web. Importantly, chemical metabolism by biota is assumed to be zero in KABAM unless evidence indicates such metabolism is likely to affect the model predictions substantially. Example output from the bioaccumulation model is provided in Ap pendix E

By default, KABAM assumes zero for the metabolism rate constant (K m 

### ). For oxathiapiprolin, direct estimates of the metabolism rate constant (k m 

### ) were not available.

### 71 Four pesticide

- specific inputs are required to estimate oxathiapiprolin residue concentrations in aquatic organism tissues: 1) log K ow 

### , 2) K oc 

### , 3) aqueous concentration of oxathiapiprolin, and 4) sediment pore water concentrations of oxathiapiprolin. The K oc 

### and log K ow 

### are based on registrant

- submitted studies (see Tables 2.1 and 3.5 ). It is noted that the KABAM estimated time to stead y state for oxathiapiprolin is 3 days based on environmental fate properties. SWCC provides 3

- day average EECs as part of the output , and so the 4

- day average EEC from the PA vegetable NMC scenario (which had the highest peak EECs of all proposed uses of oxathiapiprolin was used

. Table 3. 31 below shows other model input parameters based on the scenario from SWCC generatin g the highest peak EECs (PA vegetable) NMC

38 Table 3.31

. KABAM input v alues for o xathiapiprolin

Parameter Input Value Source


### Pesticide Name Oxathiapiprolin

-- Log K OW 

### 3.6 Product Chemistry
K OC 

### 12

, 810 

### 49011270 and 49011271
Highest Exposure Scenario Modeled 

### Use patterns Fruiting vegetables (all) ( PA vegetable NMC scenario ) ( Label application instructions )
P ore water concentration (ppb) Peak = 0.741 ppb

Total pesticide concentration in water (ppb) 4

- day average = 2.79 ppb



### Table 3. 32 below summaries the dose and dietary based EECs of various mammalian and avian species consuming oxathiapiprolin contaminated fish.

39 Table 3. 32

. EECs for mammals and birds consuming fish contaminated by oxathiapiprolin

Wildlife species EECs Dose Based (mg/kg

- bw/d) Dietary based (ppm)
Mammal ian Fog/water shrew 0.24 0.40
Rice rat/star

- nosed mole 0.19 0.40
Small mink 0.15 0.52 Large mink 0.12 0.52
Small river otter 0.10 0.52 Large river otter 0.09 0.55
Avian Sandpipers 0.41 0.40
Cranes 0.05 0.40
Rails 0.27 0.46
Herons 0.07 0.46 Small osprey 0.10 0.52 White pelican 0.06 0.52

### 72 

## IV. E COLOGICAL 

## E FFECTS 

## C HARACTERIZATION



### In screening

- level ecological risk assessments, effects characterization describes the types of effects a pesticide can produce in an aquatic or terrestrial organism. This characterization is based on registrant

- submitted studies that describe acute and ch ronic effects toxicity information for various aquatic and terrestrial animals and plants. Toxicity testing reported in this section does not represent all species of birds, mammals, or aquatic organisms. Only a few surrogate species for both freshwater fi sh and birds are used to represent all freshwater fish (2000+) and bird (680+) species in the United States. For mammals, acute studies are usually limited to Norway rat or the house mouse. Estuarine/marine testing is usually limited to a crustacean, a mol lusk , and a fish. Also, neither reptiles nor amphibians are tested. The risk assessment assumes that birds serve as a surrogate for the terrestrial

- phase amphibians and reptiles. This assessment also assumes that freshwater fish serve as a surrogate for aq uatic

- phase amphibians.

4.1. Aquatic Effects

Acute and chronic laboratory studies with oxathiapiprolin on aquatic organisms provide information regarding survival, growth, and reproduction. Data are available on the technical grade active ingredient (TGAI) an d the effects o n freshwater and estuarine/marine fish and invertebrates, aquatic vascular and nonvascular plants (algae) , and freshwater and estuarine/marine sediment dwelling organisms. Additionally acute toxicity data are available for certain taxa on t he oil dispersion typical end use product (TEP) of oxathiapiprolin on rainbow trout, daphnia magna, and freshwater green algae. Finally, an extensive suite of acute toxicity studies are available on rainbow trout, daphnia magna, and freshwater green algae for the various degradation and transformation products of oxathiapiprolin. These studies are discussed above in the Section 3.4.1.2.

Freshwater Fish

Acute toxicity studies with TGAI oxathiapiprolin were available for 2 species of freshwater fish, as well as one TEP (oil dispersion formulation) for the rainbow trout ( Table 4.1 )

. In a study conducted with TGAI

, rainbow trout ( Oncorhynchus mykiss

- MRID 49011289 ), oxathiapiprolin was administered in a static exposure system at mean measured concentrations ranging from 0.057

– 0.69 mg a.i/L ( as well as negative and solvent control). There was no mortality or clinical signs of toxicity that were observed during the test. The 96

- hour LC 50 

### was therefore determined to be >0.69 mg a.i/L. This study was classified as acceptable. Similarly , in an acute toxicity study conducted on bluegill sunfish ( Lepomis macrochirus

– MRID 49011290), TGAI oxathiapiprolin was not associated with any mortality or clinical signs of toxicity. The tested range of mean measured concentrations were 0.060

– 0.72 mg a.i/L ( as well as negative and solvent control). The 96

- hour LC 50 

### was determined to be >0.72 mg a.i/L and this study is classified as acceptable.

In an acute toxicity study with the rainbow trout, formulated oxathiapiprolin ( oil dispersion, 10.4% a.i) was administered in a static exposure system with mean measured concentrations ranging from 0.12

– 0.51 mg a.i/L ( as well as negative control). There was no mortality observed durin g the

### 73 course of the study. Clinical signs of toxicity included all fish in the two highest treatment concentrations (mean measured concentrations of 0.43 and 0.52 mg a.i/L) appearing lethargic on the first two days of the study but these fish appeared nor mal on days 3 and 4. The 96

- hour LC 50 

### was determined to be >0.52 mg a.i/L and this stud y is classified as acceptable.

40 Table 4.1

. Summary of acute t oxi city data to freshwater fish e xposed to o xathiapiprolin 1

Species Exposure System Test Substance (Purity) LC 50 (95% CI; slope) 2 Acute Toxicity Classification 3 Study Classification (MRID)

Rainbow trout ( Oncorhynch u s mykiss ) Static TGAI (95.8%) 96

- hr LC 50 : >0.69 mg/L (N/A; N/A)

Highly toxic Acceptable ( 49011289 )
Formulation (Oil dispersion) (10.4%) 96

- hr LC 50 : >0.51 mg/L (N/A; N/A) Acceptable (49050532) Bluegill sunfish ( Lepomis

mac r ochirus ) TGAI (95.8%) 96

- hr LC 50 : >0.72 mg/L (N/A; N/A) Acceptable ( 49011290)

L C 50 = Lethal concentration to 50% of the population, CI = confidence intervals, N/A = not applicable Bolded values represent the most sensitive endpoint to be used for risk estimation . In this case, although the formulation is associated with a more sensitive endpoin t, TGAI derived endpoints are used for the runoff portions of the aquatic assessment.

1 Freshwater fish are used as surrogates for aquatic

- phase amphibians.

2 Concentrations expressed in terms of mean measured active ingredient; (95% confidence intervals; s lope) if available

3 A l thou g h t h e ac u te t o x icity c la s s i f ic a t io n is “ highly toxic ,” t h e se st ud ies d i d n o t e l i c it a 50 % m o rtali t y r e s pon se

u p to t h e l i mit o f s o l ub i l i t y

. T h e designation is b a s e d o n t h e st an d a rd E P A c la s s i f ic a t io n s y st e m

. 

### There is one study available to characterize the chronic toxicity of TGAI oxathiapiprolin to freshwater fish ( Table 4.2 )

. In an early life stage (ELS) study with the rainbow trout (MRID 49011304), m ean

- measured concentrations were (<LOD, controls), 0.060, 0.12, 0.23, 0.46 and 0.74 mg a.i /L, respectively. Hatching success averaged 96 to 100% for all control and treatment levels, with no statistically

- significant differences (p>0.05) indicated at any level compared to the negative control. Similarly, for post hatch survival, time to hatch and time to swim up, there were no significant effects (p>0.05) observed during the course of the study. For all growth parameters assessed, wet weight, dry weight, and length, there was significant (p<0. 05) reductions determined at the highest treatment concentration (0.74 mg a.i/L) as compared to the control

. Clinical signs of toxicity observed during the study included the observation of a few fish in each of the three lowest treatment concentrations t o swim vertically only, but it was noted that these fish recovered from this condition later in the study

. Based on the effects on growth parameters

, the 88

- day NOAEC and LOAEC were determined to be 0.46 and 0.74 mg a.i/L, respectively. This study is cla ssified as acceptable.

41 Table 4.2. Summary of chronic toxicity data to freshwater fish e xposed to o xathiapiprolin

Species Test Substance

(Purity) Exposure system Endpoint 1 Variables Affected (% change from control) Study Classification (MRID)

Rainbow trout ( Oncorhynchos mykiss ) TGAI (95.8%) Flow

through 88

- d NOAEC: 0.46 mg/L 88

- d LOAEC : 0.74 mg/L Wet weight (↓18%)

, dry weight (↓20%) , length (↓7%) Acceptable (49011304)

### 74 NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration Bolded values represent the most sensitive endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of active ingredient



### Freshwater invertebrates

There are two acute toxicity studies available with oxathiapiprolin conducted on the freshwater invertebrate Daphnia magna , one with TGAI (95.8% a.i) and one with the oil dispersion formulation (10.2% a.i) ( Table 4.3 ) . In the study conducted with TGAI (MRID 49011316), mean measured concentrations ranged from 0.060

– 0.78 mg a.i/L ( as well as negative and solvent controls). Mor t ality was observed only at the highest treatment concentration which totaled 75%. Clinical signs of toxicity included lethargy in all surviving daphnia in the highest treatment concentration at 24 and 48 hours. At 48 hours, lethargy was observed in the three highest treatment concentrations. The 48

- hour EC 50 

### was determined to be 0.63 mg a.i/L and this study is classified

as acc eptable. In the study conducted with formulated oxathiapiprolin (10.4% a.i) , mean measured concentrations ranged from 0.07

– 0.82 mg a.i/L. There was no treatment related clinical signs of toxicity observed during the study. The 48

- hour EC 50 

### was determi ned to be >0.82 mg a.i/L and this study is classified as acceptable.

Additionally, i n a water column toxicity with the fres hwater midge (that inhabits both the sediment and the water column as part of its life cycle) test organisms were exposed to mean measured concentrations ranging from 0.04

– 0.56 mg a.i/L (as well as negative and solvent controls). There was no mortality that was observed during the study and no observations of clinical signs of toxicity. The 48

- hour LC 50 

### was determined to be >0.56 mg a.i/L and this study is classified as acceptable.

42 Table 4.3. Summary of acute toxicity data to f reshwater i nvertebrates exposed to

o xathiapiprolin

Species Exposure System Test Substance (Purity) E C 50 (95% CI; slope) 1 Acute Toxicity Classification 2 Study Classification (MRID)
Water flea ( Daphnia magna )

Static TGAI (95.8%) 48

- hr EC 50 : 0.63 mg/L (0.58

– 0.68; N/A)

Highly toxic Acceptable (49011316) Freshwater midge ( Chironomus riparius ) 48

- hr LC 50 : >0.56 mg/L (N/A; N/A) Acceptable (49011347)

Water flea Formulation (Oil dispersion) (10.4%) 48

- hr EC 50 : >0.82 mg/L (N/A; N/A) Acceptable (49050533)

E C 50 = Effect (immobilization) concentration to 50% of the population, CI = confidence intervals, N/A = not applicable Bolded values represent the most sensitive endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of active ingredient

2 A l thou g h t h e ac u te t o x icity c la s s i f ic a t io n is “ highly toxic ,” t h e se st ud ies d i d n o t e l i c it a 50 % m o rtali t y r e s pon se

u p to t h e l i m it o f s o l ub i l i t y

. T h e designation is b a s e d o n t h e st an d a rd E P A c la s s i f ic a t io n s y st e m

.



### There is one study available to characterize the chronic toxicity of TGAI oxathiapiprolin to freshwater invertebrates ( Table 4.4 )

. The study (MRID 49011330) exposed Daphnia magna to

### 75 mean measured concentrations of (<LOD, negative and solvent control ), 0.057, 0.12, 0.24, 0.45 and 0.75 mg a.i /L, respectively. There were no significant (p>0.05) effects determined on parental survival, l ength, weight, and time to first brood release . The mean number of neonates produced per surviving adult was significantly (p<0.05) reduced from the negative control at the 3 rd 

### treatment concentration (mean measured 0.24 mg a.i/L). Similar effects were n ot determined in the two concentrations above and below this group, and therefore the effect is not determined to be treatment related. Clinical signs of toxicity included o ne daphnid from the 0.057 mg a.i /L group that appeared pale, and one daphnid from the 0.24 mg a.i /L group that appeared lethargic. The 21

- day NOAEC and LOAEC were determined to be 0.75 and >0.75 mg a.i/L and this study is classified as acceptable.

43 Table 4.4. Summary of chronic toxicity data to f reshwater i nvertebrates e xposed to

o xathiapiprolin

Species Test Substance

(Purity) Exposure system Endpoint 1 Variables Affected (% change from

control) Study Classification (MRID)

Water flea ( Daphnia

magna ) TGAI (95.8%) Static renewal 21

- d NOAEC: 0.75 mg/L 21

- d LOAEC: >0.75 mg/L None Acceptable (49011330)

NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration Bolded values represent the most sensitive endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of active ingredient



### Estuarine/marine fish

One acute toxicity study is available with TGAI oxathiapiprolin (95.8% purity) to the sheepshead minnow ( Cyprinodon variegatus

- MRID 49011291

– Table 4.5 ) . Mean measured concentrations ranged from 0.048

– 0.65 mg a.i/L ( as well as negative and solvent controls). There was no mortality or clinical signs of toxicity that were observed in the study. This study is classified as acceptable.

44 Table 4.5 . Summary of acute toxicity d ata to e stuarine/marine fish e xposed to

o xathiapiprolin 1

Species Exposure System Test Substance (Purity) LC 50 (95% CI; slope) 1 Acute Toxicity Classification 2 Study Classification (MRID) Sheepshead minnow ( Cyprinodon variegatus) Static TGAI (95.8%) 96

- hr LC 50 : >0.65 mg/L (N/A; N/A) Highly toxic Acceptable ( 49011291 )

L C 50 = Lethal concentration to 50% of the population, CI = confidence intervals, N/A = not applicable Bolded values represent the most sensitive endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of active ingredient

2 A l thou g h t h e ac u te t o x icity c la s s i f ic a t io n is “ highly toxic ,” t h e se st ud ies d i d n o t e l i c it a 50 % m o rtali t y r e s pon se

u p to t h e l i mit o f s o l ub i l i t y

. T h e designation is b a s e d o n t h e st an d a rd E P A c la s s i f ic a t io n s y st e m

. 

### In a chronic ELS study with sheepshead minnow conducted with TGAI (95.8%) (MRID 49011305) fish were exposed to mean measured concentrations were (<LOD, controls), 0.031,

### 76 0.059, 0.12, 0.23 and 0.34 mg a. i /L ( Table 4.6 )

. There were no significant (p< 0.05) effects determined for hatching success, time to hatch, length, and wet weight. For dry weight, there was a significant (p<0.05) reduction as compared to the negative control in the lowest and highest treatment concentration. As there were no simil ar effects observed at the middle three concentrations, the effect at the lowest concentration was not determined to be biologically significant . There were no treatment related clinical signs of toxicity observed during the study. Based on the significa nt effect on dry weight at the highest treatment concentration, the NOAEC and LOAEC for this study are determined to be 0.23 and 0.34 mg a.i/L , respectively, and this study was classified as acceptable.

45 Table 4.6. Summary of c hronic toxicity d ata to e stuarine/marine f ish e xposed to

o xathiapiprolin

Species Test Substance

(Purity) Exposure system Endpoint 1 Variables Affected (% change from

control) Study Classification (MRID)

Sheepshead minnow ( Cyprinodon variegatus ) TGAI (95.8%) Flow

through 35

- d NOAEC: 0.23 mg/L 35

- d LOAEC: 0.34 mg/L Dry weight (↓13%) Acceptable (49011305)

NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration Bolded values represent the lowest definitive toxicity endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of active ingredient



### Two acute toxicity studies to characterize the toxicity of TGAI oxathiapiprolin are available with the mysid shrimp and the eastern oyster ( Table 4.7 ) . In a study with the mysid shrimp ( Americamysis bahia

– MRID 49011328) , test organisms were exposed to mean measured concentrations ranging from 0 .065

– 0.64 mg a.i/L ( as well as negative and solvent controls). There was 10% mortality observed in the highest treatment group and no clinical signs of toxicity

were observed during the study. The 96

- hr LC 50 

### was determined to be >0.64 mg a.i/L and this study is classified as acceptable. In a study conducted with the eastern oysters ( Crasso s trea virginica

– MRID 49011329) test organisms were exposed to mean measured concentrations ranging from 0.028

– 0.33 mg a.i/L (including negative and solvent contro ls). The maximum mean percent shell deposition that occurred was 23% and therefore a definitive EC 50 

### was not achieved

. There were no clinical signs of toxicity observed during the study. The 96

- hour EC 50 

### was determined to be >0.33 mg a.i/L and this study is classified as acceptable.

46 Table 4.7. Summary of acute toxicity d ata to e stuarine/marine i nvertebrates e xposed to

o xathiapiprolin

Species Exposure System Test Substance

(Purity) LC/ E C 50 (95% CI; slope) 1 Acute Toxicity Classification 2 Study Classification (MRID) Mysid shrimp ( Americamysis bahia ) Static TGAI (95.8%) 96

- hr LC 50 : >0.64 mg/L (N/A; N/A) Highly toxic Acceptable (49011328)

Eastern oyster ( Crasso s trea virginica ) Flow

- through TGAI (95.8%) 96

- hr EC 50 : >0.33 mg/L (N/A; N/A) Acceptable (49011329)

L C 50 /EC 50 = Lethal/effect concentration to 50% of the population, CI = confidence intervals, N/A = not applicable

### 77 Bolded values represent the lowest definitive toxicity endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of active ingredient

2 A l thou g h t h e ac u te t o x icity c la s s i f ic a t io n is “ highly toxic ,” t h e se st ud ies d i d n o t e l i c it a 50 % m o rtali t y r e s pon se

u p to t h e l i m it o f s o l ub i l i t y

. T h e designation is b a s e d o n t h e st an d a rd E P A c la s s i f ic a t io n s y st e m

.


### In a chronic life cycle study conducted with TGAI oxathiapiprolin on the mysid shrimp (MRID 49011331

– Table 4.8 ) test organisms were exposed to mean measured oxathiapiprolin concentrations of 0.029, 0.058, 0.12, 0.21 and 0.30 mg a.i

. / L, respectively (as well as negative and solvent controls)

. There was a significant (p<0.05) reduction in juvenile ( i.e. pre

- pairing) survival at the highest treatment concentration as compared to the negative control

. The mean number of young per female and mean number of young per reproductive day were significantly reduced as compared to the negative control at the three highest treatment concentrations. Male and female length and dry weight were significantly (p< 0.05) reduced at the highest treatment concentration. There were no clinical signs of toxicity observed during the course of the study. Based on significant effects to reproductive endpoints, the 32

- day NOAEC and LOAEC were determined to be 0.058 and 0.1 2 mg a.i/L , respectively, and this study is classified as acceptable.

47 Table 4.8

. Summary of chronic toxicity d ata to e stuarine/marine i nvertebrates e xposed to

o xathiapiprolin

Species Test Substance

(Purity) Exposure system Endpoint 1 Variables Affected Study Classification (MRID)

Mysid shrimp ( Americamysis bahia ) TGAI (95.8%) Flow through 32

- d NOAEC: 0.058 mg/L 32

- d LOAEC: 0.12 mg/L Mean number of young per reproductive day, mean number of young per female (↓30%) Acceptable (49011331)

NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration Bolded values represent the lowest definitive toxicity endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of active ingredient



### Benthic invertebrates

There are 3 studies available to characterize the toxicity of TGAI oxathiapiprolin and one of its degradates to sedimen t

- dwelling invertebrates ( Table 4.9 )

.

In a chronic 28

- day study with the fres hwater midge ( Chironomus riparius

- MRID 49033228), test organisms were exposed in a spiked water sediment system to mean measured co ncentrations in the sediment of 0.014 , 0.025, 0.14, 0.30, and 0.78 mg TRR (total radioactive residues)/kg ( as well as negative and solvent control s ). M ean measured concentrations in the pore water were 0.0036, 0.0084, 0.035, 0.11, and 0.25 mg TRR/L, respectively (as well as negative and solvent controls)

. There were significant effects (p<0.05) determined for t he mean development rate and mean development time at only the middle treatment concentration. As these effects did not follow a dose response, the effects were not considered to be biologically significant . The emergence ratio was significantly (p<0.05) reduced from the negative control at the two highest treatment concentrations. There were no treatment related clinical signs of toxicity observed during the course of the study. The 28

- day NOAEC and LOAEC, based on effects to percent emergence, is 0.14 mg TRR/ kg and 0.30 mg TRR/kg, respectively based on mean measured sediment

### 78 concentrations, and 0.035 mg TRR/L and 0.11 mg TRR/L , respectively, based on mean measured pore water concentrations. This study was classified as supplemental as it was conducted as a

sp iked water system rather than a spiked sediment system

, which is the test system EPA prefers for characterizing eff ects to benthic invertebrates. Additionally, EPA prefers a longer term ( i.e. 60

- day test) to characterize the effect on reproductive endpoin ts.

In a second chronic sediment toxicity study conducted with the freshwater midge, a spiked sediment system was used and was 28

- days in duration (MRID 49011348). Test organisms were exposed to mean measured concentrations in sediment of 0.69, 2.8, 8. 1 , 29 and 96 mg TRR/kg and mean measured pore water concentrations 0.12, 0.49, 1.6, 3.6, and 9.7 mg TRR/L ( as well as negative and solvent controls). There were no significant effects to mean development time but mean development rate was significantly (p< 0.05) reduced from the negative control at the highest treatment concentration. Percent emergence was significantly reduced from negative control at the three highest treatment concentrations. There were no treatment related clinical signs of toxicity ob served during the course of the study. The 28

- day NOAEC and LOAEC, based on effects to percent emergence was 2.8 and 8.1 mg TRR/kg, respectively, based on mean measured sediment concentrations and 0.49 and 1.6 mg TRR/L, respectively based on mean measured pore water concentrations. This study is scientifically sound and partially fulfills the guideline requirement for a chronic sediment study as EPA prefers a longer term ( i.e. 60

- day test) to characterize the effect on reproductive endpoints.

In a spiked sediment system study with the oxathiapiprolin degradate IN

- Q7D41 (MRID 49011349), the freshwater midge was exposed to time weight average mean measured concentrations in the sediment of 17, 36, 72, 149 and 312 mg/kg (as well as a negative and solve nt control). Time weighted average mean measured pore water concentrations were 0.37, 0.71, 1.1, 1.3, and 1.6 mg a.i/L (as well as negative and solvent controls)

. There were no significant (p>0.05) effects on emergence ratio determined. There were signi ficant reductions (p<0.05) from the negative control for mean developmental rate in the three highest treatment concentrations. The resultant NOAEC and LOAEC was 36 and 72 mg a.i/kg , respectively, based on time weighted average mean measured sediment conc entrations and 0.71 and 1.1 mg a.i/L, respectively based on time weighted average mean measured pore water concentrations. This study is scientifically sound and partially fulfills the guideline requirement for a chronic sediment study as EPA prefers a lon ger term ( i.e. 60

- day test) to characterize the effect on reproductive endpoints.

There are no studies available to characterize the toxicity of oxathiapiprolin to estuarine/marine benthic invertebrates

. The studies summarized in Table 4.9 below are s uitable for quantitative risk assessment.

48 Tabl e 4.9

. Summary of toxicity d ata to freshwater b enthic i nvertebrates e xposed to

o xathiapiprolin

Species Test Substance

(Purity) Exposure system Endpoint 1 Variables Affected Study Classification (MRID)
Freshwater

midge TGAI (95.8%) Static spiked Based on sediment concentrations: 28

- day NOAEC: 0.14 mg TRR/kg; Percent

emergence Supplemental (49033228)

### 79 Species Test Substance

(Purity) Exposure system Endpoint 1 Variables Affected Study Classification (MRID) ( Chironomus

riparius ) water system LOAEC: 0.30 mg TRR/kg

Based on pore water concentrations: NOAEC: 0.035 mg TRR/L; LOAEC: 0.11 mg TRR/L (↓80%)

,
mean development time, mean development

rate

Static spiked sediment system Based on sediment concentrations: 28

- day NOAEC: 2.8 mg TRR/kg; LOAEC: 8.1 mg TRR/kg

Based on pore water concentrations: 0.49 mg TRR/L; LOAEC: 1.6 mg TRR/L Percent

emergence (↓55%) ,
mean development

rate Supplemental (49011348)

IN

- Q7D41

(90.3%) Static spiked sediment system Based on sediment concentrations: 28

- day NOAEC: 36 mg/kg; LOAEC: 72 mg/kg

Based on pore water concentrations: 0.71 mg/L; LOAEC: 1.1 mg/L D evelopment

rate Supplemental (49011349)

NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration Bolded values represent the lowest definitive toxicity endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of mg active ingredient



### Vascular and non

- vascular aquatic plants

One vascular aquatic plant study was submitted along with five non

- vascular aquatic plant studies (algae) co nducted with TGAI oxathiapiprolin and formulated product (oil dispersion , 10.4% a.i

- Table 4.10 )

.
In the aquatic vascular plant toxicity study, Le mna gibba (duckweed) was exposed to mean measured concentrations ranging from 0. 07

– 0.79 mg a.i/L ( as well as negative and solvent controls. Frond number, biomass, and growth rate were not inhibited by more than 50% and therefore a definitive EC 50 

### was no t achieved

. Similarly , there were no significant (p > 0.05) reductions from the negative control for any assessed endpoint and therefore a definitive LOAEC was not achieved. The 7

- d EC 50 

### , NOAEC and LOAEC were determined to be >0.79, 0.79, and

> 0.79, respectively. This study is classified as acceptable.

In a study conducted with freshwater green algae ( Pseudokirchneriella subcapitata, MRID 49011332 ), TGAI oxathiapiprolin was exposed at mean measured concentrations ran ging from 0.01

– 0.14 mg a.i/L (as well as negative control)

. There were no assessed endpoints (cell density, growth rate, and area under the curve) that resulted in a 50% or greater inhibition as compared to the negative control. There was a significant (p<0.05, 7.5% effect) reduction in the area under the curve in the second lowest treatment concentration. Similar effects were not observed at concentrations higher than this and therefore this effect was not determined to be biologically significant . The 96

- hour EC 50 

### , NOAEC and LOAEC were determined to be >0.14, 0.14, and

### 80 >0.14 mg a.i/L, respectively. This study is classified as acceptable. In another study with freshwater green algae (MRID 49050534) , formulated (10.4% a.i

– oil dispersion product) oxathiapiprolin was exp osed at initial measured concentrations ranging from 0.04

– 0.54 mg a.i/L ( as well as the negative control). There was no concentration that elicited a 50% or greater inhibition as compared to the negative control . The area under the curve was significan tly (p<0.05, 24% effect)) reduced at the highest treatment concentration . The EC 50 

### , NOAEC, and LOAEC were therefore determined to be >0.54, 0.29, and 0.54 mg a.i/L, respectively. This study is classified as acceptable.

A study conducted with TGAI oxathiapiprolin on the cyanobacteria species Anabaena flos

- aquae (MRID 49011333) exposed cultures to mean measured concentrations ranging from 0.05

– 0.19 mg a.i/L ( as well as negative control )

. There were no assessed endpoints ( cell density, growth rate, and area under the curve) that resulted in a 50% or greater inhibition as compared to the negative control

. Mean area under the curve was significantly reduced (p<0.05, 14% effect) from the negative control at the second lowest treatment concentration. Similar effects were not observed at concentrations higher than this and therefore this effect was not determined to be biologically significant . The 96

- hour EC 50 

### , NOAEC and LOAEC were determined to be >0.19, 0.19, and >0.19 mg a .i/L, respectively. This study is classified as acceptable.

In a study conducted with th e marine diatom Skeletonema costatum (MRID 49011335 ), TGAI oxathiapiprolin was exposed in mean measured concentrations ranging from 0.02

– 0.46 mg a.i/L ( as well a s negative control)

. There were no assessed endpoints (cell density, growth rate, and area under the curve) that resulted in a 50% or greater inhibition as compared to the negative control. Mean area under the curve was significantly reduced (p<0.05, 42% effect) from the negative control at the highest treatment concentration. The 96

- h EC 50

, 

### NOAEC, and LOAEC were determined to be >0.46, 0.17, and 0.46 mg a.i/L, respectively. This study is classified as acceptable.

A study with the freshwater diatom Navicula pelliculosa

, (MRID 49011334 ), exposed TGAI oxathiapiprolin at mean measured concentrations ranging from 0.03

– 0.35 mg a.i/L ( as well as negative control). There were no assessed endpoints (cell density, growth rate, and area under the curve) tha t resulted in a 50% or greater inhibition as compared to the negative control or a represented a significant reduction (p>0.05) from the negative control. The 96

- h EC 50, 

### NOAEC, and LOAEC were determined to be > 0.35 , 0 .35 , and >0.35 mg a.i/L, respectively. This study is classified as acceptable.

49 Table 4.10. Summary of toxicity d ata to vascular and non

- vascular aquatic p lants e xposed to

o xathiapiprolin

Species Test Substance

(Purity) Exposure system Endpoint 1 Variables Affected Study Classification (MRID)

Duckweed ( Lemna gibba ) TGAI (95.8%) Static renewal 7

- d EC 50: >0.79 mg/L (N/A; N/A)
7

- d NOAEC: 0.058 mg/L
7

- d LOAEC: 0.12 mg/L None Acceptable (49011350)

Freshwater green TGAI Static 96

- hr EC 50 : >0.14 mg/L None Acceptable

### 81 Species Test Substance

(Purity) Exposure system Endpoint 1 Variables Affected Study Classification (MRID) algae ( Pseudokirchneriella subcapitata (98.9%) (N/A, N/A) 96

- hr NOAEC: 0.14 mg/L 96

- hr LOAEC: >0.14 mg/L (49011332)

Formulation (Oil dispersion) (10.4%) Static 96

- hr EC 50 : >0.54 mg/L (N/A, N/A) 96

- hr NOAEC: 0.29 mg/L 96

- hr LOAEC: 0.54 mg/L Area under the

curve (↓24%) Acceptable (49050534)

Cyanobacteria (Anabaena flos

aquae) TGAI (98.9%) Static 96

- hr EC 50 : >0.19 mg/L (N/A, N/A) 96

- hr NOAEC: 0.19 mg/L
96

- hr LOAEC: >0.19 mg/L None Acceptable (49011333)

Marine diatom ( Skeletonema

costatum ) TGAI (95.8%) Static 96

- hr EC 50 : >0.46 mg/L (N/A, N/A) 96

- hr NOAEC: 0.17 mg/L
96

- hr LOAEC: 0.46 mg/L Area under the

curve (↓42%) Acceptable (49011335)

Freshwater diatom ( Navicula pelliculosa ) TGAI (95.8%) Static 96

- hr EC 50 : >0.35 mg/L (N/A, N/A) 96

- hr NOAEC: 0.19 mg/L 96

- hr LOAEC: >0.35 mg/L None Acceptable ( 49011334 )

NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration EC 50 = Effect concentration to 50% of the population, CI = confidence intervals, N/A = not applicable Bolded values represent the lowest definitive toxicity endpoint to be used for risk estimation

1 Based on mean measured concentrations in terms of active ingredient



### 4.2. Ter restrial Effects

For terrestrial taxa, registrant

- submitted studies for oxathiapiprolin technical are available for acute oral, subacute dietary, and chronic exposure to birds, and acute and chronic exposure to mammals. Additional ecological effects data for oxathiapiprolin are available for honey bees that include laboratory acute contact and acute oral toxicity tests as well as a semi

- field study examining endpoints related to honey bee colony health. Finally, data on the effects of seedling

emergence and vegetative vigor for ten terrestrial plant species were submitted in support of oxathiapiprolin.

Birds

There are three avian acute oral studies to characterize the toxicity of T GAI and formulated (9.95 % a.i) oxathiapiprolin to birds ( Table 4.15 )

. In a TGAI study conducted with the northern bobwhite quail (MRID 49011283), birds were exposed to a single concentration ( i.e. limit test) of oxathiapiprolin at 2250 mg a.i/kg

- bw. There were no mortalities observed in the study as well as no treatment rel ated effects on mean body weight and food consumption based on visual inspection of the data. Additionally, there were no clinical signs of toxicity observed during the course of the study. The 14

- day LD 50 

### was therefore determined to be >2250 mg a.i/kg

- b w and this study is classified as acceptable. Similarly, in an acute oral study conducted with the zebra finch (MRID 49011284), bi r ds were exposed to a single oral dose at 2250 mg a.i/kg

- bw. There were no

### 82 mortalities, clinical sings of toxicity (includi ng regurgitation) , or effects on body weight and food consumption observed during the study. The 14

- day LD 50 

### was therefore determined to be >2250 mg a.i/kg

- bw and this study is classified as acceptable. Finally, in another northern bobwhite quail study c onducted with formulated oxathiapiprolin (9.95% a.i

– MRID 49050530), birds were dosed orally with a single dose of 2250 mg product/kg

- bw ( 224 mg a.i/kg

- bw). There were no mortalities

, clinical sings of toxicity, or effects on body weight or food consumption observed during the test. The 14

- day LD 50 

### was therefore determined to be >2250 mg product/kg

- bw and this study is classified as acceptable. Although the formulation, when adjusted for percent active ingredient yields the more sensitiv e endpoint, both the formulation endpoint and the TGAI endpoint are non

definitive, and therefore as no mortalities occurred in either study, the TGAI endpoint will be used for estimating risk.

50 Table 4.15

. Summary of acute oral toxicity studies for birds exposed to o xathiapiprolin

Species Test Substance (Purity) LD 50 (mg/kg bw); (95% CI; slope) 1,2 Toxicity Classification (MRID) Study Classification (MRID)
Northern Bobwhite Quail (Colinus virginianus ) TGAI (95.8%) 14

- d LD 50 : > 2250 (N/A; N/A) Practically non

- toxic Acceptable (49011285)

Zebra finch ( Poephila guttata ) 14

- d LD 50 : > 2250 (N/A; N/A) Practically non

- toxic Acceptable (49011284)
Northern Bobwhite Quail (Colinus virginianus ) Formulation (9.95% a.i

– oil dispersion) 14

- d LD 50 : > 224 (N/A; N/A) Practically non

- toxic Acceptable (49050530)

LD 50 = Lethal dose to 50% of the population, CI = confidence intervals, N/A = not applicable Bolded values represent the lowest definitive toxicity endpoint and are used in risk estimation

1 Based on mean measured concentrations in terms of active ingredient or mg product for formulated oxathiapiprolin



### There are 3 sub

- acute dietary toxicity studies avai lable for oxathiapiprolin ( Table 4.16 ) . In a study with the northern bobwhite quail (MRID 49011285), birds were exposed to m e an measured concentrations ranging from 570

– 5640 mg a.i/kg

- diet ( as well as the negative control group). There were no mortalit ies or clinical signs of toxicity observed at all treatment levels. Additionally, there were no effect s on body weight, body weight changes, or food consumption based on a visual inspection of the data. Similarly, in a study conducted with the mallard du ck (MRID 49011286), birds were exposed to mean measured concentrations ranging from 570

– 5640 mg a.i/kg

- diet ( as well as the negative control group ) . There were no mortalities, clinical signs of toxicity, or changes to body weight and food consumption ob served during the test. The 8

- d ay LC 50 

### values for both studies were determined to be >5640 mg a.i/kg

- diet. Both studies are classified as acceptable.

In a second sub

- acute dietary toxicity study conducted with the bobwhite quail, birds were exposed to a single concentration of formulated (9.95% a.i) oxathiapiprolin at mean measured 5640 mg product/kg in the diet (corresponding to 561.2 mg a.i/kg

- diet). As with the two studies conducted with TGAI , there were no mortalities, clinical signs of toxicity, and effect on body weight, and food consumption. The 8

- day LC 50 

### was therefore determined to be >5640 mg product/kg diet and this study is classified as acceptable. Although the formulation, when ad justed for percent active ingredient yields the more sensitive endpoint, both the formulation endpoint and the TGAI

### 83 endpoint are non

- definitive, and therefore as no mortalities occurred in either study, the TGAI endpoint will be used for estimating risk.

51 Table 4.16

. Summary of s ub

- acute dietary t oxicity d ata for birds exposed to o xathiapiprolin

Species Test Substance (Purity) LC 50 mg/kg diet); (95% CI; slope) 1 Toxicity Classification (MRID) Study Classification (MRID) Northern Bobwhite Quail (Colinus virginianus ) TGAI (95.8%) 8

- d LC 50 : >5640 (N/A; N/A) Practically non

- toxic Acceptable (49011285)
Mallard duck ( Anas platyrhynchos ) 8

- d LD 50 : > 5640 (N/A; N/A) Practically non

- toxic Acceptable (4 9011286 ) Northern Bobwhite Quail (Colinus virginianus ) Formulation (9.95% a.i

– oil dispersion) 8

- d LD 50 : > 561.2 (N/A; N/A) Practically non

- toxic Acceptable ( 49050531 )
LC 50 = Lethal concentration to 50% of the population, CI = confidence intervals, N/A = not applicable Bolded values represent the lowest definitive toxicity endpoint and are used in risk estimation

1 Based on mean measured concentrations in terms of active ingredient or mg product fo r formulated oxathiapiprolin



### There are two chronic reproduction studies available for oxathiapiprolin ( Table 4.1 7 ) . In a study conducted on the northern bobwhite quail with TGAI, birds were exposed to mean measured concentrations of 621, 920, and 1230 mg a.i/kg

- diet. There was one mortality that occur in the study at the middle treatment group. This death was not considered to be treatme nt related as necropsy showed a break between the cervical vertebra at C4 and C5 with extensive hemorrhaging. There were no clinical signs of toxicity that were observed during the course of the study. There were no treatment related effect s determined f or body weight, food consumption and all reproductive parameters assessed. The NOAEC and LOAEC for this study were determined to be 1230 and >1230 mg a.i/kg

- diet, respectively.

In a study conducted with the mallard duck (MRID 49011288), birds were expo sed to mean measured concentrations of 621, 920, and 1230 mg a.i/kg

- diet. There was one mortality that occurred in the lowest treatment concentration that was incidental and not considered to be treatment related. There were no significant effects on bod y weight or food consumption. Additionally, there were no observations of clinical signs of toxicity during the study. For reproductive parameters, there were several effect s noted. In the lowest treatment concentration (mean measured 621 mg a.i/kg

- diet ), there were significant effects (p<0.05) on hatchability that also conferred a significant decrease in the number of 14

- day old survivors as a percentage of eggs set. It is noted that two pens in this treatment concentration were associated with poor ha tchability as evidenced by percent hatch of these two pens falling below the lowest percent hatch in any replicate of the control group (63%). When these data are eliminated, the percent hatch is similar to that of the control, and therefore this effect i s not determined to be biologically significant. The assertion that these effects were not treatment related at the 620 mg a.i/kg level is further supported by the absence of any significant effects (p>0.05) at the middle treatment concentration (920 mg

a .i/kg

- diet). At the high treatment concentration (1230 mg a.i/kg

- diet), there was a significant reduction (p<0.05) in percent hatchability. Although the percent reduction from control for this effect was smaller than it was from the lowest treatment grou p (10% vs. 13% in the low treatment group), there were more replicates (4 total in the high group) that performed at or below the lowest observed replicate in the control for this parameters (63%). Given that there is no concentration

### 84 tested higher than t his, the effects seen at this concentration cannot be ruled out as being treatment related. Also observed at the highest treatment concentration was a significant decrease in number of 14

- day hatchlings per eggs set, and hatchling survival per number of h atchlings. Therefore, the NOAEC and LOAEC for this study are dete rmined to be 920 and 1230 mg a.i /kg

- diet, respectively.

52 Table 4.17. Summary of chronic toxicity data for birds exposed to o xathiapiprolin

Species % Active Ingredient (a.i.) Toxicity Endpoint ( mg a.i//kg

- diet ) +1 Endpoints affected (% change from control) Study Classification (MRID)
Northern Bobwhite Quail (Colinus virginianus ) TGAI (98.9%) NOAEC: 1230 LOAEC: >1230 None Acceptable ( 42932301 )

Mallard Duck ( Anas platyrhynchos ) TGAI ( 98.9 %) NOAEC: 920 LOAEC: 1230 Number of hatchlings/eggs set ↓10%) , 14

- day hatchlings/eggs set (↓12%) , Acceptable ( 42932302 )

Bold ed values indicate the most sensitive endpoint used for oxathiapiprolin risk estimation. NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration

1 Based on mean measured concentrations in terms of active ingredient



### Mammals

In an acute oral toxicity study with the laboratory rat ( Rattus norvegicus , MRID 49011165), rats were tested in an up down design at doses of 175, 550, 1750, and 5000 mg a.i/kg

- bw. There were no mortalities, clinical signs of toxicity, or body weight loss observed during the study. The LD 50 

### was determined to be >5000 mg a.i/kg

- bw

In a two

- generation reproduction study (MRID 49011186 and 49033235), rats were exposed to concentrations of TGAI oxathiapiprolin 0, 500, 1500, 6000, 17000 ppm. These concentrations were adjusted during the lactation period (P 1 

### and F 1 

### adults), and up to post natal day 42 for F 1 

### adults and F 2 

### adult males, to 0, 300, 900, 3500, or 10000 ppm, respectively, to achieve targeted concentration intakes. Average daily doses (premating) for P1 animals were 0, 29.2, 86.4, 346.1 or 1013.1 mg/kg/day (males ) and 0, 34.3, 105.6, 429.9 or 1210.3 mg/kg/day (females). There were no test substance

- related deaths, or effects observed in any parameter assessed in the study.

53 Table 4.18

. Summary of a cute and chronic toxicity data for mammals expos ed to

o xathiapiprolin

Species Test substance Study Type Toxicity Endpoint 1 Acute Toxicity Classification Study Classification (MRID)

Laboratory rat ( Rattus norvegicus ) TGAI Acute oral toxicity LD 50 : >5000 (N/A; N/A) mg a.i/kg

- bw Practically non

toxic Acceptable (41850805)
Multi

- generation reproductive toxicity NOAEL: 10,000 ppm (1210 mg a.i/kg

- bw/day) LOAEL : >10000 ppm -- Acceptable (49011186, 49033235)
LD 50 = Lethal dose to 50% of the population, CI = confidence intervals, N/A = not applicable NOAEC/LOAEC = No observed adverse effects concentration/lowest observed adverse effects concentration Bolded values indicate the most sensitive endpoint used for risk estimation.

1 Based on mean measured concentrations in terms of active ingredient

### 85 Non

- target Beneficial Insects

There are 5 studies available to characterize the contact or oral toxicity of TGAI, formulated, and certain degradates of oxathiapiprolin to adu lt honey bees ( Table 4.19 )

. In a combination acute contact and acute oral toxicity study with TGAI oxathiapiprolin to adult honey bees (MRID 49011351), mean measured concentration s ranging from 6.53

– 104 μg a.i/bee and 2.69

– 42.2 μg a.i/bee were used for the acute contact and acute oral studies, respectively (as well as negative control group). The percent mortality (after applying Abbott’s correction for control mortality, which was 8 and 6% for the acute contact and acute oral tests, respectively), was 4.35% in the two highest treatment groups for the acute contact study, and 6.67% in the highest treatment concentration in the acute oral study. There was no mortality observed fo r all other treatment groups for both tests. There were no clinical signs of toxicity observed for either test and this study is classified as acceptable.

A combination acute contact and acute oral toxicity study with formulated oxathiapiprolin (10.4% a.i) exposed adult honey bees (MRID 49050535) to mean measured concentrations ranging from 61.3

– 981 μg product /bee (6.38

– 102 μg a.i/bee) and 90.9

– 1349 μg product/bee (9.45

– 140 μg a.i/bee) for the acute contact and acute oral studies, respectively (as well as negative control group). The percent mortality (after applying Abbott’s correction for control mortality, which was 8 and 4% for the acute contact and acute oral tests, respectively), was 2.17, 0, 8.70, 17.4, and 21.7% for the 5 concentrations in the acute contact study, respectively and 0, 0, 0, 0, and 12.5% for the 5 concentrations in the acute oral study, respectively. Additionally, there were observations of one bee in each of the lowest, middle, and highest treatment concentration in the a cute contact study observed to be lying on its back. There was one bee in the highest treatment concentration of the

acute oral study observed with this behavior. This study is classified as acceptable.

A combination acute contact and acute oral toxici ty study with oxathiap iprolin (200 g/L SC formulation ) exposed adult honey bees (MRID 49050619 ) to mean measured concentrations ranging from 6.25

- 200 μg a.i /bee and 15.7

– 250 μg a.i/bee for the acute contact and acute oral studies, respectively (as well as negative control group). The percent mortality (after applying Abbott’s correction for control mortality, which was 4 f or the acute contact test was 0, 0, 0, 2.08, 6.25, and 10.4% for the 6 treatment groups, respectively. Mortality in the acute oral c omponent for the 5 treatment concentrations was 0, 6, 2, 6, and 8% from the lowest to highest treatment concentrations, respectively. There were no observations of clinical signs of toxicity and this study is classified as acceptable

.

In a combination acute contact and acute oral toxicity study with the degradate IN

- E8S72 to adult honey bees (MRID 49033238), mean measured concentration ranging from 6.25

– 100 μg a.i/bee and 7.10

– 109 μg a.i/bee were used for the acute contact and acute oral studies, re spectively (as well as negative control group). There was no mortality observed in the acute contact component of the study and one mortality in each of the lowest, middle, and highest treatment concentrations (mean measured concentrations of 7.10, 28.1, a nd 109 μg a.i/bee, respectively. There were no clinical signs of toxicity observed during the course of the test and this study is classified as acceptable.

### 86 In a combination acute contact and acute oral toxicity study with the degradate IN

- WR791 to adult honey bees (MRID 49033239), mean measured concentration ranging from 6.25

– 100 μg a.i/bee and 3.51

– 56.2 μg a.i/bee were used for the acute contact and acut e oral studies, respectively (as well as negative control group). There was no mortality observed in the acute contact component of the study and one mortality in the 4 th 

### concentration tested in the acute oral study (28.3 μg a.i/bee). There were no clinical signs of toxicity observed during the course of the test and this study is classified as acceptable.

54 Ta ble 4.19

. Summary of a cu te toxicity data for h oney b ees e xpose d to o xathiapiprolin

Stressor % Active Ingredient (a.i.) Study Type Toxicity Endpoint 1 Toxicity Classification Study Classification (MRID)

Oxathiapiprolin TGAI (95.8%) Acute contact 48

- hr LD 50 : >104 μg a.i/bee (N/A; N/A) Practically

non

- toxic Acceptable (49011351) Acute oral 48

- hr LC 50 > 42.0 μg a.i/bee (N/A; N/A)

Formulation (10.4% a.i.

– oil dispersion) Acute contact 48

- hr LD 50 : >981 μg product/bee (> 102 μg a.i/bee) (N/A; N/A) Practically

non

- toxic Acceptable (49050535) Acute oral 48

- hr LC 50 >1349 μg product/bee (>140 μg a.i/bee) (N/A; N/A)

Formulation (101%

- 200g/L SC formulation ) 2 Acute contact 48

- hr LD 50 : >1075 μg product/bee (> 200 μg a.i/bee) (N/A; N/A) Practically

non

- toxic Acceptable (49050619) Acute oral 48

- hr LC 50 >1344 μg product/bee (>250 μg a.i/bee) (N/A; N/A)

IN

- E8S72 TGAI (99.8%) Acute contact 48

- hr LD 50 : >100 μg a.i/bee (N/A; N/A) Practically

non

- toxic Acceptable (49033238) Acute oral 48

- hr LC 50 >109 μg a.i/bee (N/A; N/A)

IN

- WR791 TGAI (99.5%) Acute contact 48

- hr LD 50 : > 100 μg a.i/bee (N/A; N/A) Practically

non

- toxic Acceptable (49033329) Acute oral 48

- hr LC 50 >56.2 μg a.i/bee (N/A; N/A)
LD 50 / LC 50 = Lethal dose/concentration to 50% of the population, CI = confidence intervals, N/A = not applicable Bold ed values indicate the most sensitive endpoint used for oxathiapiprolin risk estimation.

1 Based on mean measured concentrations in terms of active ingredient

2 101% puri t y obtained since the analyzed content of the formulation was determined to be 201.7 g/L as compared to a nominal amount of 200 g/L.



### A semi

- field study (following OECD Test Guideline 75) was conducted for formulated oxathiapiprolin (100 g/L OD formulation ) to evaluate the effects of three applications on the brood of honey bees

. The formulation was applied three times at rates of 0.054, 0.11, and 0.16 lbs a.i/A, representing 21.6

– 64% of the maximum single application rate for the proposed uses. Honey b ee (A pis mellifera ) hives were exposed to treated plants ( Phacelia tanacetifolia ) for 7 days in the tunnel, and then monitored for additional 18 days outside of the tunnel at another site that was approximately 7 km away from the exposure site. The study i ncluded a negative control using tap

### 87 water and a positive control using fenoxycarb at 0.14 lbs a.i/A that was applied once at the same time when the third application was applied in the treatment groups. There were three replicates for each treatment. The third application was conducted when plants were flowering at day time and when bees were foraging.

There were n o biologically significant effects on the number of dead bees of all life stages ( i.e. adult bees, larvae, and pupae collapsed into one measure) , flight activity, hive strength. The highest treatment group (three application of 0.16 lbs a.i/A) was associated with a statistically significant (p<0.05) increase in mortality at Days 12 and 13 after application, but this measure recovered for the remainder of the test and the interval from day of application to test termination (Day 25 after application) determined no significant differences for mortality as compared to the negative control for all treatment groups. Similarly, flight intensity was significantly reduced at all treatment levels on the day of application but 1 day after application and 7 days after application, indicating that bees recovered from this effect.

In addition, using ma rked brood cells, the study found the brood index and the brood compensation index were consistently lower in the treatment than in the control, and the mean of brood termination rate was higher in the treatment than in the control at the end of study. How ever, the differences were slight and not statistically significant, likely because of the large variation in this metric. Specifically one replicate with the lowest treatment group had almost complete brood suppression, which was not addressed by the stu dy authors other than the statement that these data were considered to be outliers. A summary of the results can be found in Table 4.20 below.

55 Table 4.20

. Summary of semi

- field study c onduc ted with formulated ox athiapiprolin

Study Attribute Result Summary 1 Application timing and

rate On day of drilling (0.054, 0.11, and 0.16 lbs a.i/A) 13

- days post drilling (0.054, 0.11, and 0.16 lbs a.i/A) During flowering and bee flight (0.054 0.11, and 0.16 lbs a.i/A)
Number of reps/treatment 3

% of U.S.A

. max single application rate 21.6

– 64%

Crop Phacelia Exposure pathways assessed Direct contact , oral

Exposure duration In tunnel exposure: 7 days Monitoring observation (outside of tunnel) : 18 days Forager mortality 5 days before application to Day of Application: treatments ≈ control Day of application to 7 Days after application: treatments ≈ control 12 Days after application to 13 Days after application: 0.16 lbs a.i/A, ↑ (p<0.05) Day of application to 25 Days after application (bee flight interval): treatments ≈ control Flight intensity Day of application: ↓ (p<0.05) for all treatments (25

- 35% reduction) 1 Day after application: treatments ≈ controls Day of application to 7 Days after application: treatment ≈ contro l (except 6 Days after application when all treatments significant reduced from control)

### 88 Study Attribute Result Summary 1 Forager behavior Some behavioral abnormalities at all treatment concentrations that included single bees being observed motionless or with locomotion problems. All s ymptoms not considered treatment related based on similar control symptoms. Brood development 1 st CCA: treatments ≈ control
6 th and 7 th CCA (21 and 25 days after application): Colony sizes were significantly reduced for all treatments as compared to the c ontrol 25 Days after application: treatment ≈ control Development in individual cells Brood indices and compensation indices were rising during the assessment period similarly for control and all treatment groups except for at Brood area Fixing Day +17 (BFD) (15 days after application) when brood indices for treatments decreased and compens ation indices remained at similar levels as they did for the assessment conducted on BFD+10. Study limitations 1. The reference toxicant fenoxycarb showed no increased mortality above the level of control for any time point.

2. Statistical analyses w ere conducted by collapsing all the life stages of bees for the mortality results ( i.e dead honey bees, larvae, and pupae) in one parameters as opposed to three separate analyses.

3. Control mortality from Day of application to Day 7 after application a s well as Day of application to Day 25 after application ( i.e. the study period) was higher than for any other group, including for the reference toxicant, fenoxycarb.

4. Highly variable data for brood and compensation indices across replicates within a treatment, particularly for the lowest application rates, in which one replicate had almost complete brood suppression that was not addressed by the study authors other than the statement that these data were an outlier.

5. High variability in mortality d ata among the colonies before exposure
Reference toxicant effects (fenxoycarb) ↓ flight intensity at Day of application and 6 Days after application; ↓ brood and compensation indices at B F D +10; ↓ brood compensation index at BFD+17 and
BFD+23

1 Stat i st i cally significant results summarized (p<0.05)



### Additional study limitations include considerable variability for mortality data in the colonies before exposure to oxathiapiprolin. There was also higher mortality in the control for all time interval s assessed, including Day of application to Day 25 after application (study termination) than for all treatment groups as well as the reference toxicant. The sole significant finding for the reference toxicant was decreased brood and compensation indices f or Brood area Fixing Day+23 termination rate.

While significant effects were determined for mortality in the highest treatment group at Days 12 and 13 after application, as well as a significant reduction in flight intensity at all treatment groups on the day of application, these measures recovered t o the level of the negative control by study termination. This study suggests that these effects were transient in nature and that the colonies were able to compensate for these effects following exposure to formulated oxathiapiprolin in semi

- field study design.

### 89 Terrestrial Plants

There were two studies available to characterize the toxicity of oxathiapiprolin (as the formulation 100 g/L OD) to terrestrial plants ( Table 4.21 ) . In a seedling emergence study (MRID 49011398), nine species of plants were exposed for 21

- days to mean measured application rates of <LOQ (control) , 0.0064, 0.019, 0.058, 0.17 and 0.52 lbs a.i

. / A. O ilseed rape was exposed to a slightly higher spray volume and had mean measured application rates of <LOQ (control), 0.0069, 0.020, 0.062 , 0.19, and 0.56 lbs a

. i/A. The maximum proposed application rate for North America is 0.50 lbs a.i/A. There were no significant effects determined for any endpoint assessed for both monocot and dicot species. There was no treatment level that eli cited a 25% or greater inhibition as compared to the negative control. Onion biomass and height were the only two endpoints to elicit a percent inhibition of >10%, r elative to the negative control, and neither effect was sta tistically

significant (p>0.05) . The most sensitive monocot and dicot species could therefore not be determined due to a lack of toxic effects. The resultant EC 25, 

### NOAEC, and LOAEC values for monocots and dicots are > 0.5 2, 0.52, and >0.5 2 lb s a

. i

. /A, respectively. This study is class ified as acceptable.

Similarly, in a vegetative vigor study with 100 g/L OD formulated oxathiapiprolin (MRID 49011399), ten species of plants were exposed for 21

- days to mean measured application rates of <LOQ (control), 0.0069, 0.020, 0.062, 0.19 and 0.5 6 lbs a.i./A. There were no treatment related significant (p>0.05) effects determined for survival, height and weight for all species tested. There

was a significant (p<0.05) decrease in ryegrass height, with an inhibition of 11.1% as compared to the neg ative control , at the 0.062 lbs a.i./A treatment level but similar effect s were not determined in the treatment levels above or below it. The most sensitive monocot and dicot species could not be determined due to a lack of toxic effects. The resultant m onocot and dicot EC 25 

### , NOAEC, and LOAEC were >0.56, 0.56, and >0.56 lbs a.i/A, respectively. This study is classified as acceptable.

56 Table 4.22

. Summary of tox icity data for terrestrial plants exposed to o xathiapiprolin

Species Study Type Test Substance Toxicity Endpoint (lbs a.i/A) 1 Endpoints affected Study Classification (MRID)

Multiple Species Seedling Emergence 100 g/L OD formulation Monocot /Dicot : 21

- d EC 25 : > 0.52 (N/A; N/A) NOAEC: 0.52; LOAEC: >0.52 None Acceptable (49011398)

Multiple species Vegetative Vigor Monocot/Dicot : 21

- d EC 25 : > 0.56 (N/A; N/A) NOAEC: 0 .56 ; LOAEC: >0.5 6 None Acceptable (4 9011399 )

EC 25 = Effect concentration to 25 % of the population, CI = confidence intervals, N/A = not applicable Bolded values represent the most sensitive endpoints to be used for risk estimation

1 Based on mean measured application rates in terms of active ingredient

### 90 

## V. RISK CHARACTERIZATION

Risk characterization provides the final step in the risk assessment process. In this step, exposure and effects characterization are integrated to provide an estimate of risk relative to established levels of concern (LOCs; Section 5.1 ). The results are then interpreted for the risk manager through a risk description and synthesized into an overall conclusion ( Section 5.2 ). In addition, the risk description also contains a discussion of relevant sources of uncertainty in the risk assessment and sensitivit y of the risk assessment findings to important methodological assumptions.

5.1. Risk Estimation

– Integration of Exposure and Effects Data

As discussed in the problem formulation, risk characterization integrates EECs and toxicity estimates and evaluates the likelihood of adverse ecological effects to non

- target species. For oxathiapiprolin , a deterministic approach is used to evaluate the likelihood of adverse ecological effects to non

- target species. In this approach, RQs are calculated by dividing EECs by acute and chronic ecotoxicity values for non

- target species.

Risk Quotient (RQ) = Exposure Estimate/Toxicity Estimate

RQs are then compared to LOCs. These LOCs are criteria used to indicate potential risk to non

target organisms and the need to con sider regulatory action. LOC exceedance is interpreted to mean that the labeled use (or proposed use) of the pesticide has the potential to cause adverse effects on non

- target organisms. LOCs currently address the following risk presumption categories:

An imals:

• acute risk

- potential for acute risk to non

- target organisms which may warrant regulatory action in addition to restricted use classification,

• acute risk, restricted use

– potential for acute risk to non

- target organisms, but may be mitigated through restricted use classification,

• acute risk, listed species

– listed species may be potentially affected by use,

• chronic risk

– potential for chronic risk may warrant regu latory action, listed species may potentially be affected through chronic exposure,

Plants

• non - listed plant risk

- potential for effects in non

- target (non

- endangered) plants, and

• listed plant risk

– potential for effects in endangered plants.

Ri sk presumptions, along with the calculation of the corresponding RQs and LOCs, are tabulated below:

### 91 57 Table 5.1. Summary of the levels of concern used for the risk quotient method.

Risk Presumption RQ LOC

Birds and mammals

Acute Risk Diet

- based EEC/LC 50 or dose

- based EEC/ LD 50 0.5

Acute Restricted Use Diet

- based EEC/LC 50 or dose

- based EEC/ LD 50 (or LD 50 < 50 mg/kg) 0.2

Acute Endangered Species Diet

- based EEC/LC 50 or dose

- based EEC/ LD 50 0.1

Chronic Risk Diet or dose

- based EEC/NOAEC 1

Aquatic Animals

Acute Risk EEC/LC 50 or EC 50 0.5

Acute Restricted Use EEC/LC 50 or EC 50 0.1

Acute Endangered Species EEC/LC 50 or EC 50 0.05

Chronic Risk EEC/NOAEC 1

Terrestrial and Semi

- Aquatic Plants , and Aquatic Plants

Acute Risk EEC/EC 25 1

Acute Endangered Species EEC/EC 05 or NOAEC 1

Terrestrial Invertebrates

Acute risk to bees EEC (adult contact)/LD 50 (adult contact)

EEC (adult or larval oral)/LD 50 (acute or larval oral) 0.4



### 5.1.1. Risks to Non

- Target Aquatic Animals

Acute and chronic risks to aquatic animals are first estimated based on the maximum aquatic EECs determined from all 40 crop exposure scenarios modeled combined with the most sensitive endpoint from each taxonomic group, as identified in Section 4.1

. For screening purposes, this initial comparison is based on the stressor of concern (parent oxathiapiprolin only ). It is noted here that for all water column and sediment dwelling aquatic taxa, the highest peak, 21

- day, and 60

- day average EECs resulted from a scenario representing the fruiting vegetable use. The application method associated with this scenario is soil applied, which has an annual rate of 0.50 lbs a.i/A. This rate is nearly 4 fold higher than the maximum annual rate proposed for foliar uses (0.12 lbs a.i/A). As m entioned in the Use Characterization section, either a soil applied or foliar applied regimen is permitted by the label and therefore the RQs presented below derived from the highest EECs soil applied uses are protective of all other soil applied and folia r applied uses for oxathiapiprolin.

### 92 Freshwater and Estuarine/marine Fish

As discussed previously, acute risk to freshwater and estuarine/marine fish is estimated by dividing the peak surface water EEC by the 96

- hour acute LC 50 

### values from the respective freshwater and estuarine /marine fish studies. The modelling results in Table 5.2 indicate the highest peak EEC is 4.2 μg a.i/L. The most sensitive acute LC 50 

### values for freshwater fish and estuarine/marine fish

are > 690 and > 6 50 μg a.i/L , respectively. As the separation between the highest peak EEC and the most sensitive acute toxicity endpoints for fish is at least 3 orders of magnitude (due to the lack of mortality at the highest treatment concentration for both studies), th e resultant RQs are below all acute LOCs (endangered species, acute restricted use, and acute non

- lis ted species) at 0.006, and 0.006 , respectively . As these RQs were estimated with non

- definitive ( i.e. “>”) endpoints, the resultant RQs are indicated as a n unbounded “worst case” estimate of risk, which would still be below all acute LOCs. Since the scenario presented below represented the highest peak EEC, acute RQs determined from all other scenarios would be therefore be below all acute LOCs as well.

58 Table 5.2

. Summary of acute RQs for freshwater and estuarine/marine fish resulting from the highest peak EECs from the proposed uses of oxathiapiprolin

Use(s) Scenario App. Method Peak EEC (μg a

. i

. /L) Freshwater Fish
L C 50 : >690 μg a.i/L Estuarine/marine fish LC 50 : >650 μg a.i/L
Acute RQ Acute RQ Fruiting vegetables PAvegetableNMC Soil applied 4.20 <0.0 1 <0.0 1

App. = Application

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5



### For estimating chronic risk to freshwater and estuarine/marine fish, the 60

- day average EEC is compared to the most sensitive chronic NOAEC values from the respective toxicity studies. The highest 60

- day average EEC is 0.934 μg a.i/L, 3 orders of magnitude less than the most sensitive chronic NOAEC values of 430 and 260 μg a.i/L from the freshwater and estuarine/marine studies, respectively ( Table 5.3 ). As the LOC for chronic risk is 1, there are no RQs for any of the proposed uses of oxathiapiprolin that would exceed the LOC. Since the scenario presented below represented the highest 60

- day average EEC, chronic RQs determined from all other scenarios would be therefore be below the chronic LOC as well

.

59 Table 5.3

. Summary of chronic RQs for freshwater and estuarine/marine fish resulting from the highest 60

- day average EECs from the proposed uses of oxathiapiprolin

Use(s) Scenario App. Method 60

- day EEC (μg a.i./L) Freshw ater Fish NOAEC: 430 μg a.i/L Estuarine/marine fish NOAEC: 260 μg a.i/L

Chronic RQ Chronic RQ

Fruiting vegetables PAvegetableNMC Soil applied 0.934 <0.01 <0.01

App. = Application

1 C hronic risk LOC = 1

### 93 Freshwater and estuarine/marine Invertebrates

- Water Column

As with acute risk to freshwater and estuarine/marine fish, peak EECs are compared to the most sensitive acute LC 50 

### endpoints for estimating acute risk to freshwater and estuarine/ marine invertebrates. The highest peak EEC of 4.20 μg a.i/L was compared to the most sensitive acute LC 50 

### values of >540 and >330 μg a.i/L for freshwater and estuarine/marine invertebrates, respectively. The resultant acute RQs were 0.008 and 0.013, respectively, which are below all acute LOCs. Similar to acute r isk to freshwater and estuarine/marine fish, as these RQs were estimated with non

- definitive ( i.e. “>”) endpoints, the resultant RQs are indicated as an unbounded “worst case” estimate of risk, which would still be below all acute LOCs.

60 Table 5.4

. Summary of acute RQs for freshwater and estuarine/marine invertebrates resulting from the highest peak EECs from the proposed uses of oxathiapiprolin

Use(s) Scenario App. Method Peak EEC (μg a

. i

. /L) Freshwater Invertebrates
L C 50 : > 540 μg a.i/L Estuarine/marine invertebrates LC 50 : > 330 μg a.i/L

Acute RQ Acute RQ

Fruiting vegetables PAvegetableNMC Soil applied 4.20 <0.01 <0 .013

App. = Application

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5



### For estimating chronic risk to freshwater and estuarine/marine invertebrates , the 21

- day average EEC is compared to the most sensitive chronic NOAEC values from the respective toxicity studies. The highest 21

- day average EEC is 1.38 μg a.i/L for all modeled oxathiapiprolin uses

. When compared to the most sensitive NOAEC values ( Table 5.5) . The resultant RQs are below the chronic LOC of 1. As this scenario is protective of all other uses, there are no RQs for any of the proposed uses of oxat hiapiprolin that would exceed the LOC.

61 Table 5.5

. Summary of chronic RQs for freshwater and estuarine/marine invertebrates resulting from the highest 21

- day average EECs from the proposed uses of oxathiapiprolin

Use(s) Scenario App. Method 21

- day EEC (μg a.i./L) Freshwater invertebrates NOAEC: 750 μg a.i/L Estuarine/marine invertebrates NOAEC: 58 μg a.i/L

Chronic RQ Chronic RQ

Fruiting vegetables PAvegetableNMC Soil applied 1.38 <0.01 0.02

App. = Application

1 Chronic risk LOC = 1

### 94 Risk to Sediment

- Dwelling Invertebrates

Acute and chronic risk to freshwater benthic invertebrates is estimated in several different ways to account for multiple exposure routes of oxathiapiprolin to benthic invertebrates and to account for factors contributing to the bioavailability of oxathiapiprolin across those exposure routes. Acute RQs are based on the peak pore water EEC and the most sensitive water column EC 50 

### . Chronic RQs are derived sev eral different ways, accounting for the multiple exposure routes and differing bioavailability. Modeled 21

- day pore water EECs are compared to the measured pore water NOAEC from available sediment studies; modeled 21

- day sediment EECs are compared to the measured sediment NOAEC; and modeled 21

- day pore water EECs are compared to the most sensitive water column water invertebrate NOAEC.

When estimating acute RQs (peak pore water EEC/most sensitive acute water column LC 50 

### ), all RQs were estimated be <0.01, which is below all acute levels of concern. The highest peak pore water EECs resulted from a scenario within the fruiting vegetable use. Similarly, when chronic RQs were estimated using both the 21

- day pore water EEC compared to the most sensitive NOAEC based on pore water measurements as well as the 21

- day EEC compared against the most sensitive water column invertebrate NOAEC, resultant RQs were all below the chronic LOC of 1. When 21

- day sediment EE Cs were compared against the 2 8

- day NOAEC based on me an measured sediment concentrations, chronic RQs ranged from 0.17

– 2.72

. The proposed uses of oxathiapiprolin with a scenario that exceeds the chronic LOC of 1 when RQs are expressed in terms of sediment concentrations are cucurbit vegetables, fruiting v egetables, ginseng, tuberous vegetables, and ornamentals.

There are no available sediment toxicity studies for estuarine/marine sediment dwelling invertebrates for risk estimation.

62 Table 5.6

. Acute RQ and Chronic RQs for Direct Effects to Freshwater Sediment

- Dwelling Invertebrates from Oxathiapiprolin

. 1 , 6

Use(s) Scenario Acute Chronic
Peak Pore Water EECs

(μg a.i /L) Acute RQ 2 21

- day sediment

EECs (μg / Kg ) 21

- day

pore water EECs

(μg a.i /L) Chronic RQ (sediment)

3 Chronic RQ (pore water) 4 Chronic RQ (pore water / surface water) 5

Brassica vegetables FLcabbageSTD 0.062 <0.01 32 0.061 0.23 <0.01 <0.01 CAColeCropRL F_V2 0.093 <0.01 48 0.092 0.34 <0.01 <0.01

Bulb vegetables CAonion_Wirri gSTD 0.046 <0.01 24 0.046 0.17 <0.01 <0.01

GAOnion_Wirri gSTD 0.074 <0.01 38 0.073 0.27 <0.01 <0.01

WAonionsNM C 0.078 <0.01 40 0.078 0.29 <0.01 <0.01

CAGarlicRLF_ V3 0.060 <0.01 31 0.059 0.22 <0.01 <0.01

### 95 Use(s) Scenario Acute Chronic
Peak Pore Water EECs

(μg a.i /L) Acute RQ 2 21

- day sediment

EECs (μg / Kg ) 21

- day

pore water EECs

(μg a.i /L) Chronic RQ (sediment)

3 Chronic RQ (pore water) 4 Chronic RQ (pore water / surface water) 5

Cucurbit vegetables CAMelonsRLF 0.113 <0.01 58 0.110 0.41 <0.01 <0.01

STXmelonNM C 0.371 <0.01 190 0.356 1.36 <0.01 <0.01

MImelonStd 0.156 <0.01 80 0.152 0.57 <0.01 <0.01

MOmelonStd 0.255 <0.01 131 0.249 0.93 <0.01 <0.01

NJmelonStd 0.221 <0.01 113 0.216 0.81 <0.01 <0.01

FLcucumberST
D 0.234 <0.01 120 0.233 0.86 <0.01 <0.01

Fruiting vegetables FLpeppersSTD 0.245 <0.01 126 0.241 0.90 <0.01 <0.01
CAtomato_Wirr igSTD 0.110 <0.01 56 0.109 0.40 <0.01 <0.01

FLtomatoSTD_ V2 0.232 <0.01 119 0.226 0.85 <0.01 <0.01

PAtomatoSTD 0.560 <0.01 287 0.549 2.05 0.016 <0.01 PAvegetableN MC 0.741 <0.01 380 0.724 2.72 0.021 <0.01

STXvegetableN MC 0.289 <0.01 148 0.298 1.06 <0.01 <0.01

Ginseng MNsugarbeetST
D 0.313 <0.01 161 0.306 1.15 <0.01 <0.01

Leafy vegetables CAlettuceSTD 0.261 <0.01 134 0.258 0.96 <0.01 <0.01 CARowCropRL F_V2 0.197 <0.01 101 0.196 0.72 <0.01 <0.01

Peas ORsnbeansSTD 0.156 <0.01 80 0.155 0.57 <0.01 <0.01

Tobacco NCtobaccoSTD 0.205 <0.01 105 0.204 0.75 <0.01 <0.01

Tuberous vegetables CAPotatoRLF_ V2 0.063 <0.01 33 0.062 0.23 <0.01 <0.01

FLpotatoNMC 0.131 <0.01 67 0.128 0.48 <0.01 <0.01 IDNpotato_Wir rigSTD 0.094 <0.01 48 0.094 0.35 <0.01 <0.01

MEpotatoSTD 0.275 <0.01 141 0.273 1.01 <0.01 <0.01
WApotatoNMC 0.122 <0.01 63 0.121 0.45 <0.01 <0.01

NCSweetPotato STD 0.207 <0.01 106 0.205 0.76 <0.01 <0.01

CAsugarbeet_ WirrigOP_+120 0.073 <0.01 38 0.072 0.27 <0.01 <0.01

MNsugarbeetST D_+120 0.101 <0.01 52 0.100 0.37 <0.01 <0.01

Ornamentals CAnurserySTD _V2 0.222 <0.01 114 0.218 0.81 <0.01 <0.01

FLnurserySTD_ 0.276 <0.01 142 0.273 1.01 <0.01 <0.01

### 96 Use(s) Scenario Acute Chronic
Peak Pore Water EECs

(μg a.i /L) Acute RQ 2 21

- day sediment

EECs (μg / Kg ) 21

- day

pore water EECs

(μg a.i /L) Chronic RQ (sediment)

3 Chronic RQ (pore water) 4 Chronic RQ (pore water / surface water) 5
V2
MInurserySTD _V2 0.255 <0.01 131 0.253 0.93 <0.01 <0.01

NJnurserySTD_ V2 0.300 <0.01 154 0.293 1.10 <0.01 <0.01

ORnurserySTD _V2 0.148 <0.01 76 0.146 0.54 <0.01 <0.01

TNnurserySTD _V2 0.277 <0.01 142 0.270 1.02 <0.01 <0.01

Turf CATurfRLF 0.232 <0.01 119 0.230 0.85 <0.01 <0.01

FLturfSTD 0.184 <0.01 94 0.179 0.67 <0.01 <0.01

PAturfSTD 0.267 <0.01 137 0.264 0.98 <0.01 <0.01

1 Bolded and shaded values i ndicate an exceedance of an LOC

2 Based on peak pore water EEC divided by > 540 ug a.i/L (EC 50 value of most sensitive freshwater water column invertebrate

, Chironomus riparius )

3 Based on 21

- day sediment EECs divided by sediment

- based NOAEC of Chironomus riparius (MRID 49033228 ) of 140 μg a.i/kg sediment.

4 Based on 21

- day pore wat er EECs divided by pore water NOAEC of Chironomus riparius (MRID 49033228 ) of 35 μg a.i/L.

5 Based on 21

- day pore water EECs divided by 58 μg a.i/L (NOAEC value of most sensitive freshwater water column invertebrate)

6 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic risk LOC = 1



### Aquatic Plants

RQs were estimated for listed and non

- listed vascular and non

- vascular (algae) plants. The highest peak EEC values were compared against the most sensitive EC 50 

### values for vascular and non

vascular plants for the proposed uses of oxathiapiprolin to yield non

- listed aquatic plant RQs. Similarly, the highest peak EEC values were compared against the most sensitive NOAEC values for vascular and non

- vascular plants to yield listed aquatic plant RQs. The LOC for both listed and non

- listed aquatic plants is 1. When compared to the most sensitive EC 50 

### and NOAEC values for vascular and non

- vascular plants, all RQs were below the LOC of 1 ( Table 5.7 )

. For the estimat ion of non

- listed RQs for both vascular ad non

- vascular plants, a definitive EC 50 

### was not achieved ( i.e. “>” endpoint) and therefore the resultant RQs are provided below preceded by a “<” to represent an upper bound, worst case scenario of risk.

### 97 63 Table 5.7

. RQ Values for Direct Effects to Aquatic Nonvascular Plants from Oxathiapiprolin

. 1

Use (s) Scenario Application Method Peak EECs

(μg a.i /L) Aquatic Nonvascular Plants
E C 50 = >140 μg a.i/L NOAEC = 140 μg a.i/L Aquatic Vascular Plants
E C 50 = >790 μg a.i/L NOAEC = 58 μg a.i/L

Listed RQs 2 Non

listed RQs 3 Listed RQs 3 Non

- listed RQs 4

Fruiting vegetables PAvegetableNMC Soil applied 4.200 0.03 <0.03 0.07 <0.01

1 Listed aquatic plant LOC = 1; Non

- listed aquatic plant LOC = 1

2 Estimated by dividing the peak EEC by the most sensitive NOAEC

3 Estimated by dividing the peak EEC by the most sensitive EC 50



### Non

- target Terrest r i

al Animals

Acute mammalian RQ values are calculated using the rat acute oral toxicity data (LD 50 

### >5000 mg/kg b.w.) adjusted for differences in body weight for a small (15g), medium (35g) and large (1000g) mammal by T

- REX (adjusted LD 50 

### = 10989

, 8891 , and 3846 mg/kg b w., respectively) and the modeled acute dose

- based EECs for various use scenarios and diet categories. As noted in the exposure characterization section , ginseng represents the use with the highest maximum annual application rate (0.50 lbs a.i/A). The proposed labels indicate that cucurbit

, fruiting , and leafy vegetables as well as tobacco spec ify a transplant application in water via before planting followed by 2 in

- furrow soil directed applications. As T

- REX cannot simulate this use pattern, it was conservatively assumed to make one application for these uses at the maximum annual rate of 0.5

.

Tables 5.8 and 5.9 show the acute dietary

- based RQs for birds and chronic dietary based risk for birds and mammals, respectively . There were no proposed uses that resulted in acute or chronic LOC exceedances for birds and mammals on an acute and chro nic dietary basis. Despite the limitations of T

- REX in not being able to simulate the use practices for cucurbit, fruiting , and leafy vegetables as well as tobacco, the resultant RQs are still below LOC when making the previously mentioned assumptions in the modelling.

Table 5.10 shows the acute dose

- based RQs for birds and the acute and chronic dose

- based RQs for mammals. As with the dietary

- based RQs, there were no acute or chronic LOC exceedances for birds and mammals when RQs were expressed as dose

- based. It is noted that because the avian acute oral and sub

- acute dietary did not achieve definitive LD and LC 50 

### values, respectively , that these RQs would be preceded by a “< ” to present an upper bound “worst case,” scenario of risk. 64

### 98 65 Table 5.8

. Acute Dietary

- Based RQs for Birds of Different Feeding Classes Exposed to Oxathiapiprolin 1 

### (Note: As a definitive acute dietary LC 50 

### was not achieved for birds, “>”, all RQs presented in this table are preceded with a “<.”) Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items  Short Grass Tall Grass Broad

leaf Plants Fruits, pods, seeds,

etc

. Arthropods

Use(s) 

Ginseng <0.02 <0.01 <0.01 <0.01 <0.01
Cucurbit, fruiting, and leafy vegetables; tobacco <0.02 <0.01 <0.01 <0.01 <0.01

Ornamentals <0.02 <0.01 <0.01 <0.01 <0.01

Turf <0.02 <0.01 < 0.01 <0.01 <0.01

1 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5



### 66 Table 5.9

. Chronic Dietary

- Based RQs for Birds and Mammals of Different Feeding Classes Exposed to Oxathiapiprolin 1
Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items  Short Grass Tall Grass Broad

leaf Plants Fruits, pods, seeds,

etc

. Arthropods

Use(s) 

BIRDS

Ginseng 0.11 0.05 0.06 0.01 0.04
Cucurbit, fruiting, and leafy vegetables; tobacco 0.13 0.06 0.07 0.01 0.05

Ornamentals 0.12 0.06 0.07 0.01 0.05

Turf 0.12 0.05 0.07 0.01 0.05

MAMMALS

Ginseng 0.01 <0.01 <0.01 <0.01 <0.01
Cucurbit, fruiting, and leafy vegetables; tobacco 0.01 <0.01 <0.01 <0.01 <0.01

Ornamentals 0.01 <0.01 <0.01 <0.01 <0.01

Turf 0.01 <0.01 <0.01 <0.01 <0.01

1 Acute endangered species LOC = 0.1; acute restricted use LOC = 0.2; acute high risk LOC = 0.5

### 99 67 Table 5.10

. Acute Dose

- based RQ values for Birds and Mammals Exposed to Oxathiapiprolin 1,2,3 

### (Note: As a definitive acute oral
LD 50 

### was not achieved for birds and mammals , “>”, all acute dose based RQs presented in this table are preceded with a “<.” )

Primary Feeding Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Sm Med Lg Sm Med Lg Sm Med Lg

Dietary Items Short GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.Short GrassTall GrassBroadleafPlantsFruits, pods,seeds,etc.
Arthropods Seeds, grains, etc

. Use(s) 

ACUTE DOSE

- BASED BIRDS

Ginseng 0.07 0.03 0.04 <0.01 0.03 0.02 0.02 <0.01 0.01 <0.01 0.01 <0.01 0.03 0.01 <0.01 <0.01 <0.01 <0.01
Cucurbit, fruiting, and leafy vegetables; tobacco 0.08 0.04 0.05 0.01 0.04 0.0 2 0.0 2 <0.01 0.01 0.01 0.01 <0.01 0.03 0.01 <0.01 <0.01 <0.01 <0.01

Ornamentals 0.08 0.04 0.04 <0.01 0.04 0.02 0.02 <0.01 0.01 0.01 0.01 <0.01 0.03 0.01 <0.01 <0.01 <0.01 <0.01

Turf 0.08 0.04 0.04 <0.01 0.03 0.02 0.02 <0.01 0.01 <0.01 0.01 <0.01 0.03 0.01 <0.01 <0.01 <0.01 <0.01

ACUTE DOSE

- BASED MAMMALS

Ginseng 0.01 <0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01
Cucurbit, fruiting, and leafy vegetables; tobacco 0.01 <0.01 0.01 <0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

Ornamentals 0.01 <0.01 0.01 <0.01 0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

Turf 0.01 <0.01 0.01 <0.01 0.01 0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

CHRONIC DOSE

- BASED MAMMALS

Ginseng 0.04 0.02 0.02 <0.01 0.03 0.01 0.02 <0.01 0.02 0.01 0.01 <0.01 0.01 0.01 0.01 <0.01 <0.01 <0.01
Cucurbit, fruiting, and leafy vegetables; tobacco 0.04 0.02 0.02 <0.01 0.04 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 <0.01 <0.01

Ornamentals 0.04 0.02 0.02 <0.01 0.03 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 <0.01 <0.01 <0.01 <0.01

Turf 0.04 0.02 0.02 <0.01 0.03 0.02 0.02 <0.01 0.02 0.01 0.01 <0.01 0.02 0.01 0.01 <0.01 <0.01 <0.01

### 100 Risk to birds and mammals resulting from the ingestion of contaminated fish

As outlined previously, the KABAM model was used to calculate risk quotients from a bioaccumulation pathway for food items that may be consumed by birds and mammals for the modeled scenario (PA vegetable NMC) that represents the highest 4

- day average (2.79 μg a.i/L) of oxathiapiprolin in surface water (based on model estimated 3 day time to steady state). Using this highest e stimate of exposure, and therefore being protective of all other proposed uses of oxathiapiprolin, there were no exceedances of any acute or chronic LOC for birds and mammals ingesting contaminated food items (all RQs were <0.01). See Appendix E for the output of KABAM.

Non

- target b eneficial insects (Tier I)

Risk to non

- target beneficial insects (using honey bee as a surrogate) was estimated using two exposure routes to adult honey bees: dietary and contact. Honey bee larval data are not avail able and therefore risk estimation to this life stage is not possible. Risk estimates are available for the proposed foliar applications and soil application of oxathiapiprolin ( Table 5.11 )

For foliar applications, the oxathiapiprolin dose is provided as values that are adjusted to account for the maximum single application rate. For generating RQs, dietary based exposure values are compared to oral toxicity data for adult workers and contact exposure values are compared to acute contact toxici ty data for adult workers bees. When comparing the adjusted doses (based on a maximum proposed single application rate of 0.25 lbs a.i/A), the resultant acute RQs for diet and contact based risk to adult honey bees is 0.19 and <0.01, respectively. As the acute o ral component of the available study did not achieve a definitive LD 50 

### ( i.e. “>” value), the resultant acute RQ is preceded by a “<” to indicate an upper bound, “worst case,” scenario of risk. The acute contact and acute oral based RQs for foliar applicat ions of oxathiapiprolin are below the acute LOC of 0.4

For soil applications, the max imum annual rate of oxathiapiprolin (0.5 lbs a.i/A) is used along with other parameters described in the Briggs Model approach to derive a Briggs estimate of exposure. This estimate is multiplied by the daily consumption rate of adult worker bee (0.292 g/day) to generate a Briggs EEC that is compared against the acute oral LD 50



### . The resultant RQ is 0.13. As the acute oral component of the available study did not achiev e a definitive LD 50 

### ( i.e. “>” value), the resultant acute RQ is preceded by a “<” to indicate an upper bound, “worst case,” scenario of risk. The acute oral based RQ for soil application of oxathiapiprolin below the acute LOC of 0.4.

68 Table 5.11

. Summary of Tier I acute RQs to honey bees resulting from foliar and soil applied uses of oxathiapiprolin. Foliar applied

Life stage Exposure Type Dose (μg a.i/bee per 1 lb a.i/A) 1 Oxathiapiprolin Dose for Maximum Application Rate ( μg a.i/bee per 0.25 lb a.i/A) Acute RQ Chronic RQ

Adult Diet (nectar and pollen) 32 8 <0.19 N/A

Adult Direct contact 2.7 0.68 <0.01 N/A Soil applied

### 101 Life Stage Exposure Type Max annual application rate (lbs a.i/A) Briggs estimate 3 Briggs EEC 4 Acute RQ Chronic RQ

Adult Diet 0.5 0.019 0.006 <0.13 N/A N/A = not applicable , acute risk LOC = 0.4

1 Source: USEPA 2014 “Guidance for Assessing Pesticide Risks to Bees.”
2 Based on a 48

- h acute oral LD 50 of >42 μg a.i/bee and acute contact LD 50 of >104 μg a.i/bee for parent oxathiapiprolin ( MRID 49011351 

### ).

3 Der i ved from Briggs Model approach using Log K OW of 3.6 and K OC of 12810 L/kg)

4 Briggs estimate * 0.29 (adult bee nectar and pollen consumption rate in g/day)



### Terrestrial plants

As indicated previously in the terrestrial exposure assessment, Tier II seedling emergence and vegetative vigor toxicity tests did not establish EC estimates, i.e ., the EC 25 

### values were higher than the highest treatment rate te sted, for oxathiapiprolin

. The highest application rates tested in these studies were approximately 2.2 X the maximum single application rate of 0. 25 lb s a.i/A proposed for oxathiapiprolin. Furthermore, NOAEC values for terrestrial plants also exceeded th e maximum single application rate of oxathiapiprolin tested. Therefore, no exposure modeling or risk estimation was conducted for terrestrial plants since the non

- listed and listed species LOC of 1.0 could not be exceeded

5.2. Risk Description

– Interpreta tion of Direct Effects

Risks to Aquatic Animals

Fish

Risk estimation using the highest peak and 60

- day average EECs for acute and chronic risk, respectively to freshwater and estuarine/marine fish resulted in no acute or chronic RQs exceeding their respective LOCs. The results from the fruiting vegetable sc enario yielded the highest EECs. A summary of the highest RQs is shown in Table 5.12 below which would be protective of all other proposed uses of oxathiapiprolin.

Clinical signs of toxicity observed in an acute freshwater fish study conducted with formu lated oxathiapiprolin (oil dispersion formulation, 10.4% a.i) included fish appearing lethargic on the first 2 days of the study. However, these fish appeared normal on Days 3 and 4 of the study and the concentrations that these effects were observed at ( mean measured concentrations of 0.43 and 0.52 mg a.i/L) are approximately two orders of magnitude above the highest peak EEC determined for all proposed uses of oxathiapiprolin. Similarly, in a chronic ELS study with freshwater fish, clinical signs of tox icity included the observation of a few fish in each of the three lowest treatment concentrations to swim vertically only, but these fish recovered from this conditions later in the test. These concentrations (mean measured 60

– 230 μg a.i/L) range from a pproximately 2

- 3 orders of magnitude above the level of the highest 60

- day average EEC of 0.93 μg a.i/L. Additionally, this study determined significant effects on length, we weight, and dry weight at the

### 102 0.74 mg a.i/L concentration. This concentration i s approximately 4 fold higher than the reported solubility for oxathiapiprolin (0.18 mg/L).

As oxathiapiprolin is a new active ingredient, there are no wildlife incidents reported for fish and oxathiapiprolin. Additionally no known monitoring data are available. There are therefore no direct risk concerns for freshwater and estuarine/marine fis h resulting from the proposed uses of oxathiapiprolin.

69 Table 5.12

. Summary of acute and chronic RQs for freshwater and estuarine/marine fish resulting from the highest peak and 60

- day average EECs from the proposed uses of oxathiapiprolin
Exposure Freshwater Fish Estuarine/marine fish

Acute <0.01 <0.01

Chronic <0.01 <0.01

App. = Application

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5 ; chronic LOC = 1



### Aquatic Invertebrates

Risk estimation using the highest peak and 21

- day average EECs for acute and chronic risk, respectively to freshwater and estuarine/marine invertebrates resulted in no acute or chronic RQs exceeding their respective LOCs. The results from the fruiting veg etable scenario yielded the highest EECs. A summary of the highest RQs is shown in Table 5.13 below which would be protective of all other proposed uses of oxathiapiprolin.

Clinical signs of toxicity observed in an acute freshwater invertebrate study c onducted with TGAI oxathiapiprolin included lethargy observed in all surviving daphnia at the highest treatment concentration (0.78 mg a.i/L). Additionally there was 75% mortality that occurred at this concentration, yielding a 48

- hr EC 50 

### of 0.63 mg a.i/L . This concentration is approximately 3.5 fold higher than the reported solubility of oxathiapiprolin (0.18 mg/L). In a chronic life cycle study with the estuarine/marine invertebrate mysid shrimp, there were significant reductions in the mean number of young per female at concentrations as low as 0.12 mg a.i/L (120 μg a.i/L). This concentration is approximately two orders of magnitude above the highest 21

- day average EEC (1.38 μg a.i/L).

As oxathiapiprolin is a new active ingredient, there are no wildlife incidents reported for aquatic invertebrates and oxathiapiprolin. Additionally no known monitoring data are available. There are therefore no direct risk concerns for freshwater and estuarine/marine invertebrates resulting from the proposed u ses of oxathiapiprolin.

### 103 70 Table 5.13

. Summary of acute and chronic RQs for freshwater and estuarine/marine invertebrates resulting from the highest peak and 21

- day averages from the proposed uses of oxathiapiprolin
Exposure Freshwater invertebrates Estuarine/marine invertebrates

Acute <0.01 <0.013

Chronic <0.01 0.02

App. = Application

1 Acute listed species LOC = 0.05; acute restricted use LOC = 0.1, acute high risk LOC = 0.5; chronic LOC = 1



### Sediment

- Dwelling invertebrates

Risk estimation for freshwater sediment

- dwelling invertebrates (there was no sediment data available for estuarine/marine sediment dwelling invertebrates) indicate acute and chronic risk below their respective levels of concern for all proposed uses of oxa thiapiprolin when EECs and endpoints are expressed in terms of pore and surface water measurements. For chronic RQs comparing 21

- day sediment based EECs against the most sensitive NOAEC expressed in terms of sediment concentrations, RQs were below the chr onic LOC of 1 for the proposed uses on brassica vegetables, bulb vegetables, leafy vegetables, peas, tobacco, and turf. For the proposed uses on cucurbit vegetables, fruiting vegetables, ginseng, tuberous vegetables, and ornamentals, RQs ranged from 1.01

– 2.72

.

As discussed previously, sediment toxicity studies for the freshwater midge are available as a spiked water and spiked sediment system. The endpoints from the spiked water system were more sensitive and were therefore used for risk estimation. It is noted, however, that the sediment based endpoints from the spiked sediment system were approximately one order of magnitude less sensitive than those derived from the spiked water system. When estimating RQs with these endpoints, all chronic sedime nt based RQs would fall below the chronic LOC of 1.

Both the spiked sediment and spiked water sediment studies expressed endpoints based on sediment and pore water concentrations in terms of total radioactive residues of oxathiapiprolin. For the purpos es of this risk assessment, 1 mg TRR/kg sediment and 1 mg TTR/L is equated to 1 mg a.i/kg sediment and 1 mg a.i/L oxathiapiprolin, respectively. This assumption is suitable for when a chemical is shown to be stable in the sediment. Available environmenta l fate data show that oxathiapiprolin persist s for over 120 days in both aerobic aquatic/sediment studies and anaerobic aquatic metabolism studies.

The OECD guidelines by which these sediment studies adhered to state that selection of the spiked water or spiked sediment system depends on the intended application of the test. The spiked water system is intended to simulate a spray drift event and is u seful for other types of exposure (including chemical spills) except accumulation processes lasting longer than the test period. 11 

### The spiked sediment system, however, is intended to simulate accumulating levels of chemicals

11 http://www.oecd

ilibrary.org/docserver/download/9721901e.pdf?expires=1427328663&id=id&accname=guest&checksum=23F3099 50A46EB8E3A3AD0A27D2136D8

### 104 persisting in the sediment. 12 

### As mentioned above, available environmental fate data show that oxathiapiprolin persist for over 120 days in both aerobic aquatic/sediment studies and anaerobic aquatic metabolism studies.

In the spiked sediment study, sediment concentrations remained rela tively stable throughout the 28

- day test, while overlying water concentrations increased approximately 5 fold and pore water concentrations rising by almost a factor of 2 before day 7 before dropping roughly 50% of that value by Day 28. In the spiked wate r system, sediment concentrations rose by approximately one order of magnitude throughout the course of the 28

- day study, while overlying water concentrations remained relatively stable, and pore water concentrations rose by approximately one order of magn itude. Both studies equilibrated the sediment system for 2 and a half days and it is an uncertainty as to how the sediment and pore water concentrations would have differed with a longer time to equilibrate.

As the chronic sediment based RQs using endp oints from the spiked water system marginally exceed the chronic LOC for some uses while there are no chronic LOC exceedances when using sediment based RQs using endpoints from the spiked sediment system, it is an uncertainty to what extent oxathiapiprolin applications would impact sediment

- dwelling invertebrates. While there are no available chronic sediment data for estuarine/marine sediment dwelling invertebrates, a similar level of risk to this taxa as for freshwater sediment dwelling invertebrates can not be precluded.

Aquatic Plants

As indicated in the risk estimation section, there was no exceedance of the listed and non

- listed LOC of 1 for vascular and non

- vascular aquatic plants using the highest peak EECs determined for oxathiapiprolin ( Table 5.14 ).

The available study on vascular aquatic plants did not determine any significant effects up to highest concentrations tested which was approximately 4 fold higher than the reported solubility limit of oxathiapiprolin (0.18 mg/L). For non

- vascular aquatic plants (algae), the most sensitive species tested with freshwater green algae with EC 50 

### and NOAEC values determined to be >0.14 and 0.14 mg a.i/L ( i.e. no significant effects determined up to and including the highest treatment concentration), res pectively which is approximately at the level of solubility of oxathiapiprolin.

71 T able 5.14

. Summary of listed and non

- listed RQs for vascular and non

- vascular aquatic plants resulting from the highest peak EECs from the propos ed uses of oxathiapiprolin
Vascular aquatic plants Non

- vascular aquatic plants

Listed 0.07 0.03

Non

- listed <0.01 <0.03

1 Listed and non

- listed aquatic plant LOC = 1

12 http://www.oecd

ilibrary.org/docserver/download/9721801e.pdf?expires=1427328708&id=id&accname=guest&checksum=FA196D D0FD8A0BE59D350341EDF74DC6

### 105 Risks to Terrestrial Animals

Birds and Mammals

The analysis conducted in risk estimation determined there to be no avian acute dose or dietary

based RQ that exceeded any acute LOC. Additionally, there were no chronic avian dietary

- based RQs that were in exceedance of the chronic LOC. There were simil ar findings for mammals as there were no acute dose

- based or chronic dose and dietary

- based RQs that exceeded their respective LOCs. A summary of the overall acute and chronic risk profile for oxathiapiprolin based on the exposure scenario producing the highest terrestrial EECs and the most sensitive species within each taxonomic group is shown below (Table 5.15 )

.

72 Table 5.15

. Summary of the acute and c hronic risk p rofile for o xathiapiprolin for birds and mammals

Exposure Avia n Dose

- Based RQ Avian Dietary

Based RQ Mammalian Dose

Based RQ Mammalian Dietary

- Based RQ 

### Acute <0.08 <0.02 <0.01 N/A Chronic N/A 0.12 0.04 0.01

1 RQ values based on the maximum terrestrial EECs derived from 1 single application at the maximum annual rate (0.5 lbs a.i/A) ; see risk estimation Section 5.1 for the derivation of these RQ values

2 Acute avian dose and dietary

- based RQs as well as mammalian acute dose

- based RQs are preceded with a “<” due to the respective studies that the toxicity endpoints were derived from determined non

- definitive ( i.e. “>”) endpoints.



### It is noted here (and has been previously mentioned) that the modelling scenario generating the highest terrestrial EECs to estimate the RQs shown above made several conservative assumption s to represent the cucurbit, fruiting, and leafy vegetables uses as well as tobacco. The proposed label specifies (with the soil applied oil dispersion formulation) a 3 application regimen starting with a water transplant application before planting, foll owed by 2 in furrow soil direct applications with
a 7

- day interval The total amount of oxathiapiprolin applied for this use pattern totals 0.50 lbs a.i/A, which is the maximum annual use rate. Due to the limitations of T

- REX in being unable to simulate t ransplant applications followed by soil directed in

- furrow treatments, it was conservatively assumed to make one ground spray application single application at the maximum annual application rate of 0.50 lbs a.i/A. As shown above, despite this conservativ e modelling approach, which resulted in the highest terrestrial EECs for all proposed uses of oxathiapiprolin, there were no acute or chronic RQs for birds and mammals that exceeded their respective LOCs.

Additionally, there were no mortalities or clinical signs of toxicity noted in all available acute oral and sub

- acute dietary studies for birds and mammals. In an avian reproduction study with the mallard duck, effect s on the number of hatchlings per eggs set and number of 14

- day survivors per eggs set was indicated at 1230 mg a.i/kg

- diet. The maximum dietary

- based EECs were determined to be an order of magnitude below the level of where these effects were observed.

As oxathiapiprolin is a proposed as a new chemical registration, there are no reported avian or mammalian wildlife incidents associated with this chemical.

### 106 Non

- target beneficial insects (honey bees)

The results of the Tier I acute risk estimation to adu lt honey bees via direct contact and oral exposure resulting from foliar and soil applications indicate all RQs fall below the terrestrial invertebrates acute LOC of 0.4. For the soil applications of oxathiapiprolin, exposure to the oral route for adult h oney bees was estimated using the Briggs model approach. This model is associated with several uncertainties that include empirical data used in the model being based on one plant; the use of only 2 chemical classes of pesticides to inform the model; the approach being based on non

- ionic organic chemicals; the model being based on passive transport in the xylem that may not be relevant for chemicals in the phloem; and the fact that the model uses residues in the vegetative matter of the plant as a surrogat e for pollen and nectar.

Available plant metabolism studies indicate that the degradates IN

- E8S72, IN

- WR791, and IN

RZD74 were observed in crop field trials at limits above the limit of quantitation. Acute contact and oral toxicity data for two of thes e degradates (IN

- E8S72 and IN

- WR791) indicate that these two degradates are practically non

- toxic to adult honey bees on both an acute contact and acute oral exposure basis. While data do not exist for IN

- RZD74, it was determined by the Health Effects Div ision (HED) that IN

- RZD74 would be considered as being similar to toxicity to that of
IN

- E8S72 based structural similarity. Therefore, transformation of oxathiapiprolin within the plant to the aforementioned metabolites are not expected to be of acute ris k concern to adult honey bees.

A Tier II semi field study for formulated oxathiapiprolin (oil dispersion formulation) indicates that while significant effects (p<0.05) on survival were indicated at Days 12 and 13 after application within a tunnel to Pha celia , as well as reductions in flight intensity on the day of application, these measures recovered during the course of the 25 day study. For both of these endpoints, when the entire Day of application (which represented the third application overall bu t sole application to which bees were exposed to via direct contact) to Day 25 (study termination) interval was considered, all response variables related to colony health, mortality, and foraging behavior were similar to controls. The study tested applic ation rates that represent 64% of maximum single application rates proposed for oxathiapiprolin.

Uncertainties with the current dataset include a lack of studies to characterize the acute and toxic effects to honey bee larvae. Additionally, while there were no effects determined in the acute oral toxicity study, there are no data to characterize the chronic effects of prolonged oral exposure to oxathiapiprolin which may include sub

- lethal effects. Finally, it is an uncertainty the extent of effects that would be determined had the semi

- field study been conducted using the maximum proposed single application rate. Based on the results of the Tier I risk assessment (acute contact and acute oral risk only to adult honey bees only), and the indi cation that under the test ed conditions of a semi

- field design, honey bee coloni es showed recovery of multiple response variables, the proposed uses of oxathiapiprolin are not expected to sign ificantly impact honey bees at the colony level.

### 107 Risks to Terrestrial Plants

As indicated previously in the terrestrial exposure assessment, Tier II seedling emergence and vegetative vigor toxicity tests did not establish EC estimates, i.e ., the EC 25 

### values were higher than the highest treatment rate tested, for oxathiapiprolin

. The highest application rates tested in these studies were approximately 2.2 X the maximum single application rate of 0. 25 lb s a.i/A proposed for oxathiapiprolin. Furthermo re, NOAEC values for terrestrial plants also exceeded the maximum single application rate of oxathiapiprolin tested. Therefore, no exposure modeling or risk estimation was conducted for terrestrial plants since the non

- listed and listed species LOC of 1.0 could not be exceeded

.
As oxathiapiprolin is a new active ingredient, there are no reported incidents involving plants and oxathiapiprolin usage.

Risks to birds and mammals as a result of bioaccumulation in food items

As mentioned previously , a KABAM an alysis was performed based on the log K OW 

### of oxathiapiprolin and the potential for the chemical to bioaccumulate in the tissues of aquatic organisms. As the KABAM model estimated a time to steady state for 3 days based on other inputted environmental fate information, the highest 4

- day average EEC provided by SWCC was used to estimate exposure. There were no acute or chronic LOC exceedances resulting f rom dose or dietary

- based RQs for birds and mammals ingesting oxathiapiprolin contaminated fish. All RQs were below <0.01.

5.3. Endocrine Effects

Und e r the Fe d era l F ood, D r u g a nd C osm e tic A c t ( FF D C A )

, a s a m e nd e d b y the F ood Qu a li t y P r ot ec tion A c t ( F Q P A )

, E P A is re qui re d to d e v e l op a s cr e e ni n g p r o g r a m to d e t er mine wh e t h e r

cer t a in subst a n c e s ( in c l u ding a ll p e sti c ide ac tive a nd oth e r ing re di e nts) “ m a y h a ve a n e f fec t in hum a ns th a t is simil a r to a n ef f

ec t p r od u ce d b y a n a tu ra l l y

- o c c u rr i n g e st r o g e n, or oth e r s u c h

e ndo cr ine ef f

ec ts a s the Administ ra tor m a y d e sign a t e .” F ollowing the re c omm e nd a tions of its Endo cr ine Dis r uptor Sc r e e ning a nd T e sti n g Adviso r y C ommitt e e ( ED S T A C ) , E P A d e t er min e d th a t th er e w a s s c i e nti f ic b a sis f or in c ludin g , a s p ar t of the p r o g ra m, the a nd r o g e n

- a nd t h y r oid ho r mone s y s t e ms, in a ddition to the e st r o g e n h o r mone s y st e m. E P A a lso a d opt e d ED S TA C ’ s

rec omm e nd a tion th a t the P r o g r a m in c lude e v a lu a tions of pot e nti a l ef f

ec ts in wildli fe

. F or p e sti c ide c h e mi c a ls, E P A will use F I F R A, to the e x t e nt th a t effec ts in wildli f e m a y h e lp d e t er mine wh e t h e r a sub s t a n c e m a y h a ve a n ef f

ec t in hum a ns, a nd the F F D C A a utho r i t y to re qui r e the wildli f e e v a l u a tions. As the s c i e n c e d e v e lops a nd the re so u rce s a llow, s cr e e ning o f a ddition a l ho r mone s y st e ms m a y be a dd e d to the Endo cr ine Dis r uptor Sc r e e ning P r o g r a m ( ED SP )

. W h e n the a pp r op r i a te s c r ee ni n g a nd o r t e sting p r oto c ols b e i n g c o nsid ere d und e r the Ag e n c y ’ s End o cr ine Dis r uptor S cree ni n g P r o g r a m h a ve b e e n d e v e lo p e d, oxathiapiprolin m a y be subj ec t e d to

a ddition a l s c ree ni n g a nd o r t e sting to b e tt e r c h a r a c t er i z e e f fec t s re l a t e d to e nd o cr ine dis r uption.

### 108 5.4. Threatened and Endangered Species Concerns

Based on this screening

- level assessment, there are potential risks of direct effects to listed freshwater sediment dwelling invertebrates and potential indirect effects to fish and other aquatic taxa that consume freshwater b enthic invertebrates. Potential direct effects on freshwater sediment dwelling invertebrates from the proposed uses of oxathiapiprolin may be associated with modification of Primary Constituent Elements (PCEs) of designated critical habitats, where such designations have been made. However, a t this current stage of the r egistration process, it is premature to make effects determinations for listed species until further scientific analysis and refinements are conducted, based on recommendations received from the National Academy of Sciences’ (NAS) National Research Council (NRC) April 2013 report, available at http://www.nap.edu/catalog.php?record_id=18344 . The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that are compliant with the End angered Species Act (ESA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

To make effects determinations for individual listed species, useful refinements may include, but are not limited to, analyses of: 1) more detailed, species

- spe cific ecological and biological data; 2) more detailed and accurate information on oxathiapiprolin use patterns; and 3) sub

- county level spatial proximity data for the co

- occurrence of potential effects areas and listed species and any designated critical habitat. Examples of such refinements are described below.

EFED is currently developing tools that are expected to further refine the assessment and are designed to support effects determinations for individual federally listed species and their designated critical habitats (where applicable). Scientific informat ion obtained from the Services, and other reliable sources is being collated by EFED to address all currently listed species. This information is being stored in an Office of Pesticide Programs (OPP) P esticide R egistration
I nformation S yste M (PRISM) liste d species knowledgebase. The listed species knowledgebase consists of an information repository that houses biological and behavioral information relevant to individual species ( e.g. , habitat, diet, and life history, including specific temporal and spatia l associations) and a document repository that contains supporting documents ( e.g ., USFWS recovery plans) and electronic information ( e.g ., GIS data files). For terrestrial taxa, biological information relevant to the assessment ( e.g ., diet and body weigh t) will be used to parameterize exposure estimates using a method consistent with currently used methods in the T

- REX and T

HERPS models.

Refinements will also include more detailed analyses of the registered uses and specific use patterns that result i n either “Likely to Adversely Affect” (LAA) or “Not Likely to Adversely Affect” (NLAA) determinations for federally listed species. The analyses may include more information on where, when, and how oxathiapiprolin is used on all use sites

. Actual usage d ata (when available) and national land

- cover datasets that indicate potential use sites [ e.g ., National Land Cover Dataset (NLCD), Cropland Data Layer (CDL)] may be used to support a more refined analysis of where oxathiapiprolin is reasonably expected to be used. Similarly, refinements on the timing of applications and a more in

- depth exploration of agronomic practices for oxathiapiprolin

### 109 may be included as part of the refinement.

The refinements based on individual species data; additional, detailed usa ge information, when available; and recommendations from the NRC report are expected to help to more accurately identify potential areas of effect and to better inform effects and habitat determinations for listed species and any designated critical habita ts.

5.4.1. Action Area

For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by oxathiapiprolin use and not merely the immediate area where oxathiapiprolin is applied. At the initial screening

- level, the risk assessment considers broadly described taxonomic groups and conservatively estimates exposure for organisms that are co

- located with the pesticide

treatment area.

5.4.2. Taxonomic Groups Potentially at Ri sk

If the assumptions associated with the screening

- level action area result in RQs that 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 actio n area is necessary. Furthermore, RQs below the listed species LOCs for a given taxonomic 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 ex tend 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 locations of use sites are considered to dete rmine the extent to which screening assumptions regarding an action area apply to a particular listed organism. These subsequent refinement steps will consider how this information would impact the action area for a particular listed organism and potentia lly include areas of exposure that are downwind and downstream of the pesticide use site.

Assessment endpoints, exposure pathways, the conceptual models addressing the proposed oxathiapiprolin uses, and the associated exposure and effects analyses conduct ed for the oxathiapiprolin screening

- level risk assessment are in Sections 2 to 3 . The assessment endpoints used in the screening

- level risk assessment include those defined operationally as reduced survival and reproductive impairment for both aquatic an d terrestrial animal species and survival, reproduction, and growth of aquatic and terrestrial plant species from both direct acute and chronic exposures. These assessment endpoints address the standard set forth in the Endangered Species Act requiring fe deral agencies to ensure that any action they authorize does not appreciably 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 based taxonomic groups in the screening

- level risk assessment presented in Section 4.

### 110 Both acute and chronic risk to listed species LOCs are considered in the screening

- level risk

assessm ent to identify direct and indirect effects to taxa of listed species. This section identifies direct effect concerns, by taxa, that are triggered by exceeding listed species LOCs in the screening

- level risk assessment ( Table ), with an evaluation of the potential probability of individual effects for exposures that may occur at the established listed species LOC ( T able )

. 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 assessmen t findings to listed species. Additionally, the results of the screen for indirect effects to listed species, using direct effect acute and chronic LOCs for each taxonomic group, is presented and evaluated.

Table 5.16 Potential e f fects to federally listed taxa a sso ciated with direct or indirect e ffects from the proposed u ses of oxathiapiprolin

Listed Plant Taxon Direct Effects Indirect Effects to Listed Taxon through Direct Effects on ...

Terrestrial and semi

- aquatic plants

– monocots and dicots No No

Aquatic nonvascular plants No No

Aquatic vascular plants No No

Listed Animal Taxon Direct Effects Indirect Effects to Listed Taxon through Direct Effects on ... Acute Chronic

Terrestrial invertebrates No 1 ND ND

Mammals No No No

Birds No No No Reptiles No No No Amphibians No No No
Freshwater fish No No No Freshwater invertebrates (crustaceans) No No No
Molluscs No ND No
Estuarine/marine fish No No No

Estuarine/marine invertebrates (crustaceans) No No No

Freshwater benthic organisms No Yes 2 Yes 3

Estuarine/marine benthic organisms ND ND 4 ND 4

ND = Not determined

1 Based on Tier I analysis of adult honey bees, risk conclusions for larval honey bees could not be determined based on lack of data

2 Based on chronic LOC exceedance for certain uses using spiked water based endpoints from available toxicity study. No chronic LOC exceedance when endpoints from the spiked sediment system were used.

3 Indirect effects to fish and other aquatic taxa that eat freshwater benthic organisms

. 4 Although not data were available to characterize the toxicity of oxathiapiprolin to estuarine/ marine benthic organisms, the determinations made for freshwater benthic organisms suggest risk above the LOC could be indicated for this taxa as well.

### 111 The ri sk assessment determined that for certain proposed uses of oxathiapiprolin, that there were no acute or chronic LOC exceedances of any LOC all taxa assessed. For these uses, which include brassica vegetables, bulb vegetables, leafy vegetables, peas, tobac co, and turf, a “no effect” call can be made to listed species. For all other proposed uses that include cucurbit vegetables, fruiting vegetables, ginseng, tuberous vegetables, and ornamentals, there was at least one scenario assessed for which there was an exceedance of an LOC. For all uses where there was an exceedance, the taxa concerned was freshwater sediment dwelling invertebrates exposed to oxathiapiprolin on a chronic basis. It is noted that for the tuberous vegetable use scenarios that were ass essed, the highest RQ estimated was 1.01, marginally above the chronic LOC of 1.

### 112 

## VI. D ESCRIPTION OF 

## A SSUMPTIONS 

## , L IMITATIONS 

## , U NCERTAINTIES 

## , S TRENGTHS AND 

## D ATA 

## G APS



### Exposure for all Taxa

There are a number of areas of uncertainty in the aquatic and terrestrial risk assessments. The toxicity assessment for terrestrial and aquatic plants and animals is limited by the number of species tested in the available toxicity studies. Use of toxici ty data on representative species does not provide information on the potential variability in susceptibility to acute and chronic

exposures.

For each proposed use, the risk assessment is based on the maximum application rate on the proposed label. The f requency at which actual uses approach these maximum scenarios is dependent on the resistance to the pesticide, the timing of applications, and market forces. Exposure and risks could be overestimated if the actual application rates, frequency of applicati on, or number of applications are lower than the input parameters used for the conservative exposure scenario that was modeled

Exposure for Aquatic Species

This risk assessment relies on best available estimates of environmental fate and physicochemical properties, maximum application rate of oxathiapiprolin , maximum number of applications, and the shortest interval between applications. However, several model ing limitations are noted and should be considered in interpreting the results of this aquatic risk assessment.

• The frequency at which actual oxathiapiprolin uses approach the use estimates modeled is dependent on resistance to the fungicide , timing of applications, and market forces. In general, model output values represent the upper

- bound e stimates of concentrations that might be observed in surface water due to the application of oxathiapiprolin , given available data and model limitations.

• Major uncertainties associated with the standard runoff scenario include the physical construct of the watershed and representation of vulnerable aquatic environments for different geographic regions. The physicochemical properties (pH, redox conditions, etc. ) of the standard farm pond are based on a Georgia farm pond. These properties are likely to be regionally specific because of local hydrogeological conditions. Any alteration in water quality parameters may impact the environmental behavior of a pes ticide. The farm pond represents a well

- mixed , static water body. Because the farm pond is a static water body (no flow through), it does not account for pesticide removal through flow through or water releases. The lack of flow through the farm pond pr ovides an environmental condition for accumulation of persistent pesticides. The assumption of uniform mixing does not account for stratification due to thermoclines ( e.g. , seasonal stratification in deep water bodies). Additionally, the dimensions of th e standard runoff scenario assume a watershed area to water body volume ratio of 10 ha: 20,000 m 3 

### . This ratio is recommended

### 113 to maintain a sustainable constructed pond in the Southeastern United States. The use of higher watershed area to water body volu me ratios (as recommended for sustainable ponds in drier regions of the United States) may lead to higher pesticide concentrations when compared to the standard watershed area to water body volume ratio.

• The standard runoff scenario assumes uniform soils and agronomic management practices across the standard 10 hectare field. Soils can vary substantially across even small areas; this variation is not reflected in the model simulations. Additionally, the impact of unique soil characteristics and soil management practices ( e.g. , tile drainage) are not considered in the standard runoff scenario. The assumption of uniform site and management conditions is not expected to represent some site

- specific conditio ns. Extrapolating the risk conclusions from the standard pond scenario to other aquatic habitats ( e.g. , marshes, streams, creeks, and shallow rivers, intermittent aquatic areas) may either underestimate or overestimate the potential risks in those habitat s.

• Aquatic EECs are based on a conservative scenario the entire watershed area is impacted by a treated crop. However, in reality, only a percentage of the watershed is impacted by a crop treatment.

• For an acute risk assessment, there is only a one

- day averaging time for exposure. Use of such a “peak” concentration with a 1

- in

- 10 year annual return frequency, implies that

exposure sufficient to elicit acute effects comparable to those observed over more protracted exposure periods tested in t he laboratory, typically 48 to 96 hours. In the absence of data regarding time

- to

- toxic event analyses and latent responses to peak exposure, the degree to which risk is overestimated cannot be quantified.

Exposure for Terrestrial Species

This risk ass essment relies on the best available estimates of environmental fate and physicochemical properties, maximum application rate of oxathiapiprolin , maximum number of applications, and the shortest interval between applications. However, several uncertaintie s and model limitations are noted and should be considered in interpreting the results of this terrestrial risk assessment.

• Dietary Exposure

For screening terrestrial risk assessments, a generic bird or mammal is assumed to consume 100% of its diet on food which is contaminated with oxathiapiprolin from the application site. This assumption may lead to an overestimation of exposure to species that do not occupy the treated field. The actual habitat requirements of any particular terrestrial species are not considered, and it is assumed that species occupy, exclusively and permanently, the treated area being modeled. This assumption leads to a maximum level of exposure in the risk assessment.

• Dermal Exposure

### 114 The screening assessment does not cons ider oxathiapiprolin dermal exposure to terrestrial organisms. The Agency is actively pursuing modeling techniques to account for dermal exposure via direct application of spray and by incidental contact with contaminated vegetation, soil and

water.

• Inhal ation Exposure

Preliminary results of the screening level tool STIR (described earlier in this assessment) indicate that inhalation exposure alone is not expected to be a significant route of exposure for oxathiapiprolin to wildlife. The input and output file can be found in Appendix B.

• Drinking Water Exposure

Preliminary results of the screening level tool SIP (described earlier in this assessment) indicate that drinking water exposure alone is not expected to be a significant route of exposure for oxathiapiprolin to wildlife. The input and output file can be found in Appendix C

.

Effects Assessment for all taxa

As the data available to support the terrestrial and aquatic effects assessment for oxathiapiprolin is largely complete, the primary uncertainty with the available data is the presence of non

- definitive endpoints for several taxa. Non

- definitive endpoints were reached for acute oral and dietary studies for birds, acute oral data for rats, acute toxicit y studies for honey bees, acute studies for freshwater and estuarine/marine fish, acute studies and chronic studies for freshwater invertebrates and aquatic and terrestrial plant studies. These non

- definitive endpoints were “ > ,” values (which would yield a “ < ” RQ) for all taxa for which these endpoints were utilized for in risk estimation

. In these cases, while it is an uncertainty where the actual RQ would fall, it can be stated that these RQs would fall below all acute and chronic levels of concern.

• Ag e Class and Sensitivity of Effects Thresholds

It is generally recognized that test organism age may have a significant impact on the observed sensitivity to a toxicant. The screening risk assessment acute toxicity data for fish are collected on juvenile fish and aquatic invertebrate acute testing is performed on recommended immature age classes. Similarly, acute dietary testing with birds is also performed on juveniles, with mallard being 5

- 10 days old and quail at 10

- 14 days of age.

Testing of juveni les may overestimate the toxicity of direct acting pesticides in adults. As juvenile organisms do not have fully developed metabolic systems, they may not possess the ability to transform and detoxify xenobiotics equivalent to the older/adult organism. The screening risk assessment has no current provisions for a generally applied method that accounts for this uncertainty. In so far as the available toxicity data may provide ranges of sensitivity information

### 115 with respect to age class, the risk assessment u ses the most sensitive life

- stage information as the conservative screening endpoint.

• Lack of Effects Data for Amphibians and Reptiles

Currently, toxicity studies on amphibians and reptiles are not required for pesticide registration. Since these data are lacking, the Agency uses fish as surrogates for aquatic phase amphibians and birds as surrogates for terrestrial phase amphibians and reptiles. If other species are more or less sensitive to oxathiapiprolin than the surrogates, risks may be under

- or o verestimated, respectively. The Agency is not limited to a base set of surrogate toxicity information in establishing risk assessment conclusions. The Agency also considers toxicity data on non

- standard test species when available. Further research is nee ded to determine whether, in general, reptiles and terrestrial

- phase amphibians are suitably represented by bird species in assessing risks for oxathiapiprolin and fish are an appropriate surrogate for aquatic

- phase amphibians.

• Use of the Most Sensitive Species Tested

Although the screening risk assessment relies on a selected toxicity endpoint from the most sensitive species tested, it does not necessarily mean that the selected toxicity endpoints reflect sensitivity of the most sensitive species existing in a given environment. The relative position of the most sensitive species tested in the distribution of all possible species is a function of the overall variability among species to a particular chemical. The relationship be tween the sensitivity of the most sensitive tested species versus wild species (including listed species) is unknown and a source of significant uncertainty. In addition, in the case of listed species, there is uncertainty regarding the relationship of the listed species' sensitivity and the most sensitive species tested.

Identification of Data Gaps

Ecological Effects

The suite of ecotoxicity studies submitted for parent oxathiapiprolin and the various degradation products is extensive. Risk estimation determined there to be chronic risk above the level of the LOC to freshwater sediment dwelling organisms for certain u ses when endpoints were expressed in terms of sediment. This finding was true for endpoints derived from the spiked water system but endpoints derived from the spiked sediment system did not yield RQs above the LOC. There is uncertainty in the toxicity o f oxathiapiprolin to estuarine/marine sediment dwelling organisms.

Although no study is available to characterize the toxicity to estuarine/marine organisms, the current suite of data for water column invertebrate indicate that estuarine/marine organisms are not disproportionately more sensitive than freshwater organsisms . Additionally, as indicated above, the two chronic freshwater sediment toxicity studies indicate a level of risk below the level of concern for most of the proposed uses. For the uses that do exceed the chronic level of concern, the exceedances are marg inal. Therefore, given that longer term sediment toxicity studies, as opposed to the guideline subchronic 10

- day toxicity studies were submitted for freshwater

### 116 invertebrates and the presumption of a similar level of risk to estuarine/marine sediment dwe lling organisms, no further studies characterzing the toxicity to estuarine/marine sediment dwelling invertebrates are not needed as they are determined to have little overall added value to the current risk picture.

Additionally, there are no data avai lable to characterize the acute and chronic toxicity to honey bee larvae. Despite the available acute oral toxicity study showing no effects to adult honey bees, a chronic 10

- day study is not available to characterize any potential sublethal effects from prolonged oral exposure to oxathiapiprolin.

### 117 

## VII. REFERENCES

Enviro nmental Fate Studies

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490112

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490111

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490112

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490112

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490112

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490112

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490112

- 52 Anderson, C., Wardrope, L. 2012 DPX

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490112

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490112

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- 27214 ; GLP: Yes ; Published: No

490112

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490112

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490112

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- 29820 ; GLP: Yes ; Published: No

### 118 490112

- 63 Rice, F. 2012b Terrestrial field dissipation of DPX

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- 29813 ; GLP: Yes ; Published: No

490112

- 67 Rice, F. 2012c Terrestrial field dissipation of DPX

- QGU42 fungicide on bare soil in Texas, 2010, USA ; ABC Laboratories, Inc. (Missouri ) ; DuPont

29818 ; GLP: Yes ; Published: No

490112

- 66 Rice, F. 2012d Terrestrial field dissipation of DPX

- QGU42 fungicide on bare soil and bare soil under covered conditions in Florida, 2010, USA ; ABC Laboratories, Inc. (Missouri) ; DuPont

- 29817 ; GLP: Yes ; Published:
No

490112

- 59 Rice, F. 2012a Terrestrial field dissipation of DPX

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29823 ; GLP: Yes ; Published: No

490112

- 64 Vincent, T.P. 2012 Terrestrial field dissipation of DPX

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- 29814 ; GLP: Yes ; Published: No

490112

- 65 Vincent, T.P. 2013a Terrestrial field dissipation of DPX

- QGU42 on bare soil in British Col umbia, 2010, Canada ; ABC Laboratories, Inc. (Missouri)
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- 29816 ; GLP: Yes ; Published: No

49033209 Vincent, T.P. 2013b Freezer storage stability of DPX

- QGU42 and its metabolites in soils ABC Laboratories, Inc. (Missouri) ; DuPont

- 31384 ; GLP: Yes ; Pub lished: No

490112

- 70 Manjunatha, S. 2010 14 C

- DPX

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- 28425 ; GLP:
Yes ; Published: No

490112

- 71 Manjunatha, S. 2013 14 C

- DPX

- QGU42: Batch equilibrium (adsorption/desorption) in a soil ; Advinus Therapeutics Private Limited ; DuPont

- 36141 ; GLP:
Yes ; Published: No

490112

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- 32058 ; GLP: Yes ; Published: No

490112

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- 32059 ; GLP:
Yes ; Published: No

490112

- 74 Sannappa, H. 2012b 14 C

- IN

- QPS10: Batch equilibrium (adsorption/desorption) in five soils ; Advinus Therapeutics Private Limited ; DuPont

- 32066 ; GLP:
Yes ; Published: No

490112

- 76 Schaefer, E.C., Ponizovsky, A. 2012 14 C

- IN

- RAB06: Batch equilibrium (adsorption/desorption) in five soils ; Wildlife International Ltd (USA) ; DuPont

- 32063 ; GLP: Yes Published: No

490111

- 28 Manikandan, K.N. 2012 DPX

- QGU42 metabolites: Laboratory study of adsorption coefficient (K oc ) and partition coefficient (K ow ) by HPLC method Advinus Therapeutics Limited ; DuPont

- 33852 ; GLP: Yes ; Published: No

490111

- 21 Anand, H.S. 2010 14 C

- DPX

- QGU42: Laboratory study of hydrolysis as a function of pH ; Advinus Therapeutics Private Limited ; DuPont

- 28424, Revision No. 1 ; GLP: Yes ; Published: No

490111

- 22 Wardrope, L. 2011 DPX

- QGU42: Photodegradation in pH 7 buffer and natural water Charles River Laboratories (UK) ; DuPont

- 28074 ; GLP: Yes ; Published: No

### 119 490112

- 79 Cleland, H. 2012 [ 14 C]

- DPX

- QGU42: Degradability and fate in the water/sediment system ; Charles River Laboratories (UK) ; DuPont

- 28073 ; GLP: Yes Published: No

490112

- 80 McCorquodale, G. 2013 Anaerobic aquatic metabolism of [ 14 C]

- DPX

- QGU42 in two water/sediment systems ; Charles River Laboratories (UK) ; uPont

28458, Revision No. 2 ; GLP: Yes ; Published: No

490112

- 81 Wardrope, L. 2012a Anaerobic aquatic metabolism of [ 14 C]

- DPX

- QGU42 in two water/sediment systems ; Charles River Laboratories (UK)
DuPont

- 32708 ; GLP: Yes ; Published: No

490112

- 82 Suresh, G. 2013 Plant uptake of IN

- E8S72, IN

- RAB06 and IN

- RDT31 by agricultural crops from aqueous solutions under greenhouse conditions International Institute of Biotechnology and Toxicology (IIBAT) ; DuPont

- 34970 ; GLP: Yes ; Published: No

49421301 Henze, R.; Stry, J. 2014 Analytical Method for the Determination of DPX

- QGU42 and Metabolites IN

- E8S72, IN

- QPS10, IN

- RDT31 and IN

- RAB06 in Soil Using LC/MS/MS. Project Number: DUPONT/31005, DUPONT/29816, DUPONT/29823. Unpublished study prepared by E.I. Du Pont de Nemours and Compa ny. 47p.

49011152 Henze, R.; Stry, J. 2010 Analytical Method for the Determination of DPX

- QGU42 and Metabolites IN

- E8S72, IN

- QPS10, IN

- RDT31 and IN

- RAB06 in Soil Using LC/MS/MS. Project Number: DUPONT/31005. Unpublished study prepared by E. I. du Pont de Nemours and Company. 124p.

49011153 Henze, R.; Stry, J. 2013 Analytical Method for the Determination of DPX

- QGU42 and Metabolites IN

- E8S72, IN

- QPS10, IN

- RDT31 and IN

- RAB06 in Soil Using LC/MS/MS. Project Number: DUPONT/31005. Unpublished study prepared by E. I. du Pont de Nemours and Company. 38p.

49011154 Ju, L. 2011 Independent Laboratory Validation of Analytical Method for the Determination of DPX

- QGU42 and Metabolites IN

- E8S72, IN

QPS10, IN

- RDT31 and IN

- RAB06 in Soil Using LC/MS/MS. Project Number: D UPONT/31141, AP100812. Unpublished study prepared by Alliance Pharma, Inc. 65p.

49011156 Henze, R.; Stry, J. 2010 Analytical Method for the Determination of DPX

- QGU42 and Metabolites IN

- Q7D41, and IN

- RAB06 in Soil Using LC/MS/MS. Project Number: DUPONT/28806. Unpublished study prepared by E. I. du Pont de Nemours and Company. 96p.

49011157 Henze, R.; Stry, J. 2011 Analytical Method for the Determination of DPX

- QGU42 and Metabolites in Water Using LC/MS/MS. Project Number: DUPONT/32124. Unpublished study prepared by E. I. du Pont de Nemours and Company. 139p.

49011158 Henze, R.; Stry, J. 2013 Analytical Method for the Determination of DPX

- QGU42 and Metabolites in Water Using LC/MS/MS. Project Number: DUPONT/32124. Unpublished study prepared by E. I. du Pont de Nemours and Company. 71p.

49011159 Xu, A. 2012 Independent Laboratory Validation of the Residue Analytica l Method for DPX

- QGU42 and its Metabolites in Water as Described in DuPont

- 32124. Project Number: DUPONT/32693 32148. Unpublished study prepared by Product Safety Laboratories. 135p.

49011160 Henze, R.; Stry, J. 2012 Analytical Method for Determination o f DPX

- QGU42 in Water Using LC/UV. Project Number: DUPONT/32692. Unpublished study prepared by E. I. du Pont de Nemours and Company. 38p.

### 120 Ecological Effects Studies

MRID Author(s) Year Title Acute oral toxicity to birds

49011283 Hubbard, P.M., and J.B.

Beavers. 2011 DPX

- QGU42 Technical: An Acute Oral Toxicity Study with the Northern Bobwhite. Unpublished study performed by Wildlife International., Ltd., Easton, MD. Laboratory Project No. 112

- 677. Study sponsored by E. I. du Pont de Nemours and Company, Wilmington, DE. Study initiated January 28, 2011 and submitted September 7, 2011.

49011284 Hubbard, P.M., and J.B.

Beavers. 2011 DPX

- QGU42 Technical: An Acute Oral Toxicity Study with the Zebra Finch (Poephila Guttata). Unpublished study performed by Wildlife International., Ltd., Easton, MD. Laboratory Project No.
112

- 678. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated February 7, 2011 and submitted September 7, 2011.

49050530 Hubbard, P.M., and J.B.

Beavers. 2012 DPX

- QGU42 100 g/L OD: An Acute Oral Toxicity Study with the Northern Bobwhite. Unpublished study performed by Wildli fe International., Ltd., Easton, MD. Laboratory Project No. 112

- 711. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated December 12, 2011 and submitted February 28, 2012. Avian dietary toxicity

49011285 Hubbard, P.M., K.H.

Martin and J.B.

Beavers. 2011 DPX

- QGU42 Technical: A Dietary LC50 Study with the Northern Bobwhite. Unpublished study performed by Wildlife International Ltd., Easton, MD. Laboratory Project No. 112

- 675. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated March 2, 2011 and submitted September 6, 2011.

49011286 Hubbard, P.M., K.H.

Martin and J.B.

Beavers. 2011 DPX

- QGU42 Technical: A Dietary LC50 Study with the Mallard. Unpublished study performed by Wildlife International Ltd., Easton, MD. Laboratory Project No. 112

- 676. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated March 2, 2011 and submitted September 6, 2011.

49050531 Hubbard, P.M., K.H.

Martin and J.B.

Beavers. 2012 DPX

- QGU42 100 g/L OD: A Dietary LC50 Study with the Northern Bobwhite. Unpublished study performed by Wildlife International Ltd., Easton, M D. Laboratory Project No. 112

- 710. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated December 14, 2011 and submitted February 28, 2012. Chronic Avian reproduction

49011287 Temple, D.L., et al. 2012 DPX

- QGU42: A Reproduction Study with the Northern Bobwhite. Unpublished study performed by Wildlife International Ltd., Easton, MD. Laboratory Project No. 112

- 681. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated July 7, 2011 and submitted April 4, 2012.

49011288 Temple, D.L., et al. 2012 DPX

- QGU42: A Reproduction Study with the Mallard. Unpublished study performed by Wildlife International Ltd., Easton, MD. Laboratory Project No. 112

- 682. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated July 7, 2 011 and submitted April 4, 2012.

### 121 Ecological Effects Studies

MRID Author(s) Year Title Acute toxicity to fish

49011289 Minderhout, T., et. al. 2012 DPX

- QGU42 Technical: A 96

- Hour Static Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss). An unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory report number: 112A

- 368. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated August 31, 2011, completed December 19, 2011, and revised January 5, 2012.

49050532 Minderhout, T., et. al. 2011 DPX

- QGU42 100 g/L OD: A 96

- Hour Static Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss). An unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory report number: 112A

- 380. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated September 9, 2011 and completed November 3, 2011.

49011290 Minderhout, T., et. al. 2011 DPX

- QGU42 Technical: A 96

- Hour Static Acute Toxicity Test with the Bluegill (Lepomis macrochirus). An unpublished study performed by Wildlife International, Ltd., Easton, Maryland, USA. Laboratory report number: 112A

- 371. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated Se ptember 19, 2011 and completed on November 7, 2011.

49011291 Minderhout, T., et. al. 2011 DPX

- QGU42 Technical: A 96

- Hour Static Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus). An unpublished study performed by Wildlife International, Ltd., Easton, Maryland, USA. Laboratory report number: 112A

- 372. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated September 19, 2011 and completed on November 7, 2011.

49011302 Pupp, A. and T.

Deierli ng. 2012 IN

- E8S72: Acute Toxicity of IN

- E8S72 to Rainbow Trout (Oncorhynchus mykiss) in a 96

- Hour Static Test. An unpublished study performed by the Institut für Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany. Laboratory report numbe r: 67064230. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated April 13, 2012, completed August 13, 2012, and revised September 20, 2012.

49011296 Gopi, R.A. 2011 Acute Toxicity of IN

- P3X26 to Freshwater Fish, Oncorhynchus mykiss. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory report number: 11186. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated May 25, 2011 and completed December 5, 2011.

49011294 Gopi, R.A. 2012 Acute Toxicity of IN

- Q7D41 to Freshwater Fish, Oncorhynchus mykiss. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tam il Nadu, India. Laboratory report number: 11189. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated May 25, 2011, completed March 12, 2012, and revised December 6, 2012.

49011298 Chandrasehar, G. 2012 Acute Toxicity of IN

- QFD61 to Freshwater Fish, Oncorhynchus mykiss. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory report number: 12037. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated April 2, 2012 and completed September 5, 2012.

### 122 Ecological Effects Studies

MRID Author(s) Year Title

49011301 Ayyappan, S. 2012 Acute Toxicity of IN

- QPS10 to Freshwater Fish, Oncorhynchus mykiss. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory report number: 12034. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated February 4, 2012 and completed August 7, 2012.

49011299 Pupp, A. and T.

Dei erling. 2012 IN

- RAB06: Acute Toxicity of IN

- RAB06 to Rainbow Trout (Oncorhynchus mykiss) in a 96

- Hour Static Test. An unpublished study performed by the Institut für Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany. Laboratory report number: 67074230, Revision No. 1. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated June 1, 2012, completed September 20, 2012, and revised December 19, 2012.

49011303 Gopi, R.A. 2012 Acute Toxicity of IN

- RDT31 to F reshwater Fish, Oncorhynchus mykiss. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory report number: 12032. Study sponsored by E.I. du Pont de Nemours and Company, Wilming ton, DE. Study initiated February 17, 2012 and completed June 13, 2012.

49011292 Gopi, R.A. 2012 Acute Toxicity of IN

- RYJ52 to Freshwater Fish, Oncorhynchus mykiss. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory report number: 11192. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated July 1, 2011 and completed May 7, 2012.

49011293 Gopi, R.A. 2012 Acute Toxicity of IN

- S2K66 to Freshwater Fish, Oncorhynchus mykiss. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory report number: 12022. Study sponsored by E.I. du Pont de Nemours and Company, Wi lmington, DE. Study initiated March 6, 2012 and completed September 1, 2012.

49011297 Gopi, R.A. 2012 Acute Toxicity of IN

- S2K67 to Freshwater Fish, Oncorhynchus mykiss. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory report number: 12019. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated March 6, 2012 and completed October 9, 2012. Chronic toxicity to fish

49011304 Minderhout, T., T.Z.
Kendall, and H.O Krueger. 2012 DPX

- QGU42 Technical: An Early Life

- Stage Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss). Unpublished study performed by Wildlife International Ltd., Easton, MD. Laboratory Project No. 112A

- 389. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated July 19, 2011 and submitted February 16, 2012.
49011305 Minderhout, T., et al. 2012 DPX

- QGU42 Technical: An Early Life

- Stage Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus ). Unpublished study performed by Wildlife International, Ltd., Easton, MD. Laboratory Project No. 112A

- 373. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated December 6, 2011 and submitted April 26, 2012.
Acute toxicity to freshwater invertebrates

### 123 Ecological Effects Studies

MRID Author(s) Year Title
49011316 Minderhout, T., et. al. 2011 DPX

- QGU42 Technical: A 48

- Hour Static Acute Toxicity Test with the Cladoceran (Daphnia magna). An unpublished study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory report number: 112A

- 370. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated July 27, 2011 and completed December 19, 2011.
49050533 Sloman, T.L. 2010 DPX

- QGU42 100 g/L OD: Static, Acute, 48

- Hour EC50 to Daphnia magna. An unpublished study performed by E.I. du Pont de Nemours and Company, Haskell Laboratory for Toxicology and Industrial Medicine, Newark, Delaware. Laboratory report number: DuPont

- 30561. Study sponsored by E.I. du Pont de Nemours and Co mpany, Wilmington, Delaware. Study initiated August 11, 2010 and completed November 17, 2010.
49011320 Pupp, A. and T. Deierling. 2012 IN

- E8S72: Acute Toxicity to the Cladoceran Daphnia magna in a static 48

- hour Immobilisation Test. An unpublished stud y performed by Institut fur Biologische Analytik Und Consulting IBACON GmbH, Rossdorf, Germany. Laboratory Study No. 67063220. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated April 11, 2012 and completed August 2, 2012.
49011325 Gopi, R.A. 2011 Acute 48

- Hour Toxicity Test with IN

- P3X26 to Daphnia magna. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory Study No. 11187. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated May 25, 2011 and completed December 5, 2011.
49011323 Gopi, R.A. 2012 Acute 48

- Hour Toxicity Test with IN

- Q7D41 to Daphnia magna. An unpublished study performed by the In ternational Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory Study No. 11190. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated May 25, 2011, completed March 12, 2012, and revised Dec ember 6, 2012.
49011327 Chandrasehar, G. 2012 Acute 48

- Hour Toxicity Test with IN

- QFD61 to Daphnia magna

. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory Study No. 12036. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated April 2, 2012 and completed September 10, 2012
49011319 Ayyappan, S. 2012 Acute 48

- Hour Toxicity Test with IN

- QPS10 to Daphnia magna. An unpublished study p erformed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory Study No. 12035. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated February 4, 2012 and completed August 9, 2012.
49011317 Pupp, A. and Deierling,
T. 2012 IN

- RAB06: Acute Toxicity to the Cladoceran Daphnia magna in a Static 48

- Hour Immobilization Limit Test. An unpublished study performed by Institut fur Biologische Analytik Und Consulting IBACON GmbH, Rossdorf, Germany. Laboratory report number: 67073220. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated May 31, 2012 and completed September 4, 2012.

### 124 Ecological Effects Studies

MRID Author(s) Year Title
49011318 Gopi, R.A. 2012 Acute 48

- Hour Toxicity Test with IN

- RD T31 to Daphnia magna. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory Study No. 12033. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study in itiated February 17, 2012 and completed June 13, 2012.
49011324 Gopi, R.A. 2012 Acute 48

- Hour Toxicity Test with IN

- RSE01 to Daphnia magna. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu , India. Laboratory Study No. 11196. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated July 1, 2011, completed February 10, 2012, and revised December 6, 2012.
49011321 Gopi, R.A. 2012 Acute 48

- Hour Toxicity Test with IN

- RYJ52 to Daphnia magna. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory Study No. 11193. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated July 1, 2011 and completed May 9, 2012.
49011322 Chandrasehar, G. 2012 Acute 48

- Hour Toxicity Test with IN

- S2K66 to Daphnia magna. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), T amil Nadu, India. Laboratory Study No. 12021. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initiated March 6, 2012 and completed October 5, 2012.
49011326 Chandrasehar, G. 2012 Acute 48

- Hour Toxicity Test with IN

- S2K67 to Daphnia magna. An unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Laboratory Study No. 12018. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initi ated March 6, 2012 and completed October 9, 2012. Acute toxicity to estuarine/marine invertebrates

49011328 Minderhout, T., et.al 2011 DPX

- QGU42 Technical: A 96

- Hour Static Acute Toxicity Test with the Saltwater Mysid ( Americamysis bahia )

49011329 T. Minderhout, et.al 2012 DPX

- QGU42 Technical: A 96

- Hour Shell Deposition Test with the Eastern Oyster ( Crassostrea virginica )

Chronic toxicity to aquatic invertebrates
49011330 Minderhout, T., et al. 2011 DPX

- QGU42 Technical: A Semi

- Static Life

- Cycle Toxicity Test with the Cladoceran ( Daphnia magna ). Unpublished study performed by Wildlife International, Ltd., Easton, MD. Laboratory Project No. 112A

- 369. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, DE. Study initia ted August 31, 2011 and submitted December 14, 2011.
49011331 Claude, M.B., et al. 2012 DPX

- QGU42 Technical: A Flow

- Through Life

- Cycle Toxicity Test with the Saltwater Mysid ( Americamysis bahia ). Toxicity to aquatic plants

### 125 Ecological Effects Studies

MRID Author(s) Year Title 49011332 Kley, A. and T. Deierling. 2010 DPX

- QGU42 Technical: Effects on Growth to the Green Algae Pseudokirchneriella subcapitata in a Static Test. Unpublished study performed by the Institut für Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany. Laboratory Project ID 54092210. Work Request Number 18735. Study Code 280. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study initiated 29 January 2010 and completed 23 August 2010. 49011333 Kley, A. and T. Deierling. 2010 DPX

- QGU42 Technical: Effects on Growth to the Blue

- Green Algae Anabaena flos

- aquae in a Static Test. Unpublished study performed by the Institut für Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany. Labora tory Project ID 54091210. Work Request Number 18735. Study Code 324. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study initiated 22 January 2010 and completed 23 August 2010. 49011335 Arnie, J.R., T.Z. Kendall, and J.R. P orch. 2013 DPX

- QGU42 Technical: A 96

- Hour Toxicity Test with the Marine Diatom ( Skeletonema costatum ). Unpublished study performed by Wildlife International, Easton, Maryland. Laboratory Project ID
112P

- 121. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Sponsor Study Number DuPont

35834. Study initiated 18 October 2012 and completed 18 February 2013. 49011334 Arnie, J.R., T.Z. Kendall, and J.R. Porch. 2013 DPX

- QGU42 Technical: A 96

- Hour Toxicity Test with the Freshwater Diatom ( Navicula pelliculosa ). Unpublished study performed by Wildlife International, Easton, Maryland. Laboratory Project ID 112P

- 120A. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Sponsor Study Number DuPont

- 35843. Study initiated 18 October 2012 and completed 19 February 2013.
49050534 Dobbins, L.L., T.Z. Kendall, and H.O. Krueger. 2012 DPX

- QGU42 100 g/L OD: A 72

- Hour Toxicity Test with the Freshwater Alga (Pseudokirchneriella subcapitata). Study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Project ID 112A

- 419A. Work Request Number 19122. Service Code Number 280. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number
DuPont

- 32701. Study completed 24 Februar y 2012 and revised 04 October 2012.
49011343 Pupp, A. and T. Deierling. 2012 IN

- E8S72: Effects of IN

- E8S72 On Growth Of The Green Algae Pseudokirchneriella Subcapitata . Unpublished study performed by the Institut für Biologische Analytik und Consulting I BACON GmbH, Rossdorf, Germany. Laboratory Study Number 67061210. Work Request Number 19514. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. DuPont Number
DuPont

- 32817. Study initiated 17 April 2012 and completed 13 August 2012

. 49011346 Chandrasehar, G. 2011 IN

- P3X26: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Subcapitata . Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 11185. Work Request Number 19523. Service Code Number 280. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 32657. Study initiated 03 June 2011 and completed 06 December 2011

### 126 Ecological Effects Studies

MRID Author(s) Year Title
49011344 Ayyappan, S. 2012 IN

- Q7D41: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Subcapitata. Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 11188

. Work Request Number 19524. Service Code Number 280. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 32654. Study initiated 03 June 2011 and completed 13 March 2012. Revised report issued 27 March 2012.
49011339 Chandrasehar, G. 2012 IN

- QFD61: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Subcapitata. Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 12038. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 34402. Study initiated 02 April 2012 and completed 14 September 2012.
49011342 Chandrasehar, G. 2012 IN

- QPS10: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Subcapitata . Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 11234. Work Request Numb er 19455. Service Code Number 280. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 32816. Study initiated 16 November 2011 and completed 07 August 2012.
49011340 Pupp, A. and T. Deierling. 2012 IN

- RAB06: Effects of IN

- RAB06 On Growth Of The Green Algae Pseudokirchneriella Subcapitata. Unpublished study performed by the Institut für Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany. Laboratory Study Number 67071210. Work Request Number 1945 7. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. DuPont Number
DuPont

- 32825. Study initiated 22 May 2012 and completed 11 September 2012.
49011341 Ayyappan, S. 2012 IN

- RDT31: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Subcapitata. Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 11235. Work Request Number 19456. Service Code Number 280. Study sponsored by E .I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 32826. Study initiated 16 November 2011 and completed 13 June 2012.
49011345 Ayyappan, S. 2012 IN

- RSE01: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Subcapitata. Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 11194. Work Request Number 19531. Service Code Number 280. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 32656. Study initiated 12 July 2011 and completed 09 February 2012.

### 127 Ecological Effects Studies

MRID Author(s) Year Title
49011336 Chandrasehar, G. 2012 IN

- RYJ52: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Su bcapitata. Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 11191. Work Request Number 19532. Study Code 280. Study sponsored by E.I. du Pont de Nemours and Company, Wilming ton, Delaware. Study Number DuPont

- 32655. Study initiated 11 July 2011 and completed 07 May 2012.
49011337 Ayyappan, S. 2012 IN

- S2K66: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Subcapitata . Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 12020. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 34507. Study initiated 07 March 2012 and comple ted 22 October 2012.
49011338 Ayyappan, S. 2012 IN

- S2K67: Effects On The Growth And Growth Rate Of The Green Alga, Pseudokirchneriella Subcapitata. Unpublished study performed by the International Institute of Biotechnology and Toxicology (IIBAT), Tamil Nadu, India. Study Number 12017. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 32658. Study initiated 07 March 2012 and completed 12 October 2012
49011350 Porch, J.R., T.Z. Kendall, and H.O. Krueger. 20 11 DPX

- QGU42 Technical: A 7

- Day Static

- Renewal Toxicity Test with Duckweed (Lemna gibba G3). Study performed by Wildlife International, Ltd., Easton, Maryland. Laboratory Project IS
112A

- 364. Work Request Number 19462. Service Code Number 328. Study sponso red by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study Number DuPont

- 32480. Study initiated 04 August 2011 and completed 08 November 2011. Toxicity to sediment dwelling invertebrates
49011347 S.T. Thomas, et.al 2012 DPX

- QGU42 Technical: A 48

- Hour Static Acute Toxicity Test with Chironomus riparius
49033228 Thomas, S.T., et al 2013 14 C DPX

- QGU42: A Prolonged Sediment Toxicity Test with Chironomus Riparius Using Spiked Water.
49011348 Thomas, S.T., et al

. 2013 14 C DPX

- QGU42: A Prolonged Sediment Toxicity Test with Chironomus Riparius Using Spiked Sediment
49011349 Thomas, S.T., et al

. 2013 IN

- Q7D41: A Prolonged Sediment Toxicity Test with Chironomus Riparius Using Spiked Sediment. Effects on honey bees 49011351 T. Jeyalakshmi 2011 DPX

- QGU42 Technical: Acute Oral and Contact Toxicity to the Honey Bee, Apis mellifera L. 49033238 A. Kling 2013 IN

- E8S72: Acute Oral and Contact Toxicity to the Honeybee, Apis mellifera L. under Laboratory Conditions
49033239 A. Kling 2013 IN

- WR791: Acute Oral and Contact Toxicity to the Honeybee, Apis mellifera L. under Laboratory Conditions
49050535 T. Jeyalakshmi 2011 DPX

- QGU42 100 g/L OD: Acute Oral and Contact Toxicity to the Honey Bee, Apis mellifera L.
49050619 T. Jeyalakshmi 2012 DPX

- QGU42 200 g/L SC: Acute Oral and Contact Toxicity to the Honey Bee, Apis mellifera L.
49011353 M. Kleinhenz 2013 DPX

- QGU42 100 g/L OD: A Semi

- Field Study to Evaluate Effects of Three Applications on the Broood of Honey Bees ( Apis mellifera ; Hymenoptera. Apidae) in Phacelia Tanacetifolia in Germany 2012. Toxicity to terrestrial plants

### 128 Ecological Effects Studies

MRID Author(s) Year Title
49011398 2012 DPX

- QGU42 100 g/L OD: A Greenhouse Study to Investigate the Effects on Seedling Emergence and Growth of Ten Terrestrial Plant Species Following Soil Exposure. Unpublished study performed by ABC Laboratories, Columbia, Missouri. Laboratory Project Number: 67708. Study sponsored by E.I. DuPont de Nemours and Company, Wilmington, Delaware. Study completed June 8, 2012.
49011398 2012 DPX

- Q GU42 100 g/L OD: A Greenhouse Study to Investigate the Effects on Vegetative Vigor the Effects (Tier II) of on Vegetative Vigor of Ten Terrestrial Plant Species Following Foliar Exposure. Unpublished study performed by ABC Laboratories, Columbia, Missouri. Laboratory Project Number: 67709. Study sponsored by E.I. du Pont de Nemours and Company, Wilmington, Delaware. Study completed June 15, 2012.



### Open Literature and Government Reports

Burns, Lawrence, 1997. Exposure Analysis Modeling System (EXAMS): User Manual and System Documentation. Ecosystem Research Division, National Exposure Research Laboratory. U. S. Environmental Protection Agency, Athens, GA.

Carsel, R. F., J. C. Imhoff, P. R. Humel, J. M. Cheplick, and A. S. Donigian, Jr. 1997. PRZM

- 3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Zones: User’s Manual for Release 3.0. National Exposure Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.

Fungicid e Resistance Action Committee. FRAC code list: Fungicides sorted by mode of action. 2009. http://www.frac.info/frac/publication/anhang/FRAC_CODE_LIST.pdf

Terrestrial Resid ue Exposure Model (T

- REX), Version 1. 5

. 2 . Environmental Fate and Effects Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C.

US EPA. 1996. Ecological Effects Test Guidelines, 850.2100 Avian Acute Oral Toxicity T est. Office of Chemical Safety and Pollution Prevention. EPA 712

- C

- 96

- 139.

US EPA. 2002. Technical Basis for the Derivation of Equilibrium Partitioning Sediment Guidelines (ESGs) for the Protection of Benthic Organisms: Nonionic Organics. Office of Scien ce and Technology and Office of Research and Development. Washington, DC 20460. EPA/822

- R

- 02

- 041.

US EPA. 2004a. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency: Endangered and T hreatened Species Effects Determinations. Office of Prevention, Pesticide, and Toxic Substances.

USEPA. 2004b. Scientific Advisory Panel. March 30

- April 2, 2004: Refined (Level II) Terrestrial and Aquatic Models for Probabilistic and Ecological Asses sment of Pesticides. Available: http://www.epa.gov/scipoly/sap/meetings/2004/033004_mtg.htm

### 129 USEPA 2014a. Toxicity Testing and Ecological Risk Assessment Guidance for Benthic Invertebrates. http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/aquatic_biology_tech_team/T oxTesting_EcoRiskAssessmentForBenthicInvertebrates.pdf

USEPA. 2014b. Guidance for Assessing Pesticide Risks to Bees. Office of Pesticides Pro grams. http://www2.epa.gov/sites/production/files/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf

US Office of the Federal Registrar. 2011. Code of Federal Regulations 40 , Parts 150

- 189.

Willis and McDowell, 1987. Pesticide persistence on foliage. Environ. Contam. Toxicol. 100:23

- 73.

### 130 

## 1 Appendix A. Transformation Products (TP) and Degradates (DEGs) Observed in Environmental Fate Studies

Table of Maximum amount of applied radioactivity present as a specified compound in environmental fate studies submitted on oxathiapiprolin. 1

Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final

Oxathiapiprolin, DPX

- QGU42

IUPAC: 1

- (4

- {4

- [(5RS)

- 5

- (2,6

- difluorophenyl)

- 4,5

- dihydro

- 1,2

- oxazol

- 3

- yl]

- 1,3

- thiazol

- 2

- yl}

- 1

- piperidyl)

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl]ethanone

CAS: 1

- [4

- [4

- [5

- (2,6

- Difluorophenyl)

- 4,5

- dihydro

- 3

- isoxazolyl]

- 2

- thiazolyl]

- 1

- piperidinyl]

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl]

- ethanone

CAS Number: 1003318

- 67

- 9; Formula: C 24 H 22 F 5 N 5 O 2 S; MW: 539.53 g/mole SMILES: CC1=CC(=NN1CC(=O)N1CCC(CC1)C1=NC(=C S1)C1=NOC(C1)C1=C(F)C=CC=C1F)C(F)(F)F Water solubility at 20 o C: 0.175 mg/L; K OW = 3.6; pKa at 20 o C : Major Degradates:
IN

- RDT31

CAS Name: 1

- [4

- [4

- [5

- (2,6

- Difluorophenyl)

- 4,5

- dihydro

- 3

- isoxazolyl]

- 2

- thiazolyl]

- 4

- hydroxy

- 1

- piperidinyl]

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1 H

- pyrazol

- 1

- yl]ethanone
CAS Number: 

### 1151573

- 12

- 4 ; MW: 555.53 g/mole ; Formula: C 24 H 22 F 5 N 5 O 3 S ; Water solubility at 20 o C: 1.04 mg/L; Log K OW = 2.95

Aerobic soil 6.8 (120) 6.8 (120) Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 5.3 (120) 5.3 (120) Loamy sand

– [thiazole

- 5

- 14 C] 8.8 (90) 6.0 (134) Loamy sand

– [isoxazoline

- 5

- 14 C]
49011155 9.4 (120) 9.4 (120) Loamy sand

– [pyrazole

- 5

- 14 C] 6.2 (7) 6.0 (120) Sandy loam

– [pyrazole

- 5

- 14 C]

49011251 6.7 (120) 6.7 (120) Sandy loam

– [thiazole

- 5

- 14 C] 5.7 (120) 5.7 (120) Silty clay loam

– [pyrazole

- 5

- 14 C] 8.0 (7) 3.8 (120) Silty clay loam

– [thiazole

- 5

- 14 C]
5.5 (60) 4.2 (120) Clay loam

– [pyrazole

- 5

- 14 C] 5.3 (15) 4.2 (120) Clay loam

– [thiazole

- 5

- 14 C] 5.1 (120) 5.1 (120) Sand

– [pyrazole

- 5

- 14 C]

### 131 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 6.4 (120) 6.4 (120) Sand

– [thiazole

- 5

- 14 C]

Anaerobic Soil 4.8 (90) 4.3 (120) Sandy loam

– [pyrazole

- 5

- 14C]
49011252 3.5 (30) 3.1 (120) Sandy loam

– [isoxazoline

- 5

- 14 C]

Soil Photolysis 5.7 (10) 5.2 (15) Sand

– [pyrazole

- 5

- 14 C]
49011253 4.0 (15) 4.0 (15) Sand

– [isoxazoline

- 5

- 14 C]

Terrestrial Field Dissipation 5.5 (5) 0.9 (443) France

- Loam 49011260 7.5 (15) 2.2 (427) Germany

– Loamy sand 49011261 2.4 (102) 0.9 (538) UK

– Sandy clay loam 49011268 8.2 (50) 2.9 (253) Spain

– Sandy loam 49011269 3.4 (21) 1.1 (403) NY, USA

– Loam 49011263 7.0 (21) 1.5 (202) TX, USA

– Sandy clay loam 49011267
2.4 (29) 0.7 (295) FL, USA

- Sand 49011266 5.4 (20) 0.9 (251) CA, USA

- Loam 49011259 3.0 (49) 0.5 (741) MB, CAN

- Loam 49011264 3.0 (308) 1.4 (719) BC, CAN

– Sandy loam 49011265
IN

- RAB06

C AS: 1

- [2

- [4

- [4

- [5

- (2,6

- Difluorophenyl)

- 4,5

- dihydro

- 3

- isoxazolyl]

- 2

- thiazolyl]

- 1

- piperidinyl]

- 2

- oxoethyl]

- 3

- (trifluoromethyl)

- 1 H

- pyrazole

- 5

- carboxylic acid ; Formula: C 24 H 20 F 5 N 5 O 4 S ; MW: 569.51 g/mole ; w ater solubility: 32 mg/L; Log K OW =

- 0.05

Aerobic Soil 6.0 (90) 3.8 (120) Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 4.4 (60) 2.3 (120) Loamy sand

– [thiazole

- 5

- 14 C] 7.6 (90) 0.37 (134) Loamy sand

– [isoxazoline

- 5

- 14 C]
49011155 13.5 (90) 10.3 (120) Loamy sand

– [pyrazole

- 5

- 14 C] 6.2 (120) 6.2 (120) Sandy loam

– [pyrazole

- 5

- 14 C]

49011251 7.7 (120) 7.7 (120) Sandy loam

– [thiazole

- 5

- 14 C] 6.6 (60) 6.6 (120) Silty clay loam

– [pyrazole

- 5

- 14 C] 5.1 (7) 3.6 (120) Silty clay loam

– [thiazole

- 5

- 14 C] 7.3 (90) 5.0 (120) Clay loam

– [pyrazole

- 5

- 14 C] 7.0 (30) 5.8 (120) Clay loam

– [thiazole

- 5

- 14 C] 6.4 (120) 6.4 (120) Sand

– [pyrazole

- 5

- 14 C] 6.5 (90) 6.1 (120) Sand

– [thiazole

- 5

- 14 C]

Anaerobic Soil 4.7 (21) nd Sandy loam

– [pyrazole

- 5

- 14C]
49011252 3.7 (21) nd Sandy loam

– [isoxazoline

- 5

- 14 C]

Soil Photolysis 2.2 (7) 1.5 (13) Sand

– [pyrazole

- 5

- 14 C]
49011253 4.5 (7) 1.2 (15) Sand

– [isoxazoline

- 5

- 14 C]

Aerobic Aquatic 3.4 (38) 1.2 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Water

49011279 2.7 (60) nd Loamy sand

– [pyrazole

- 5

- 14 C]

– Sediment 5.6 (28) 1.2 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Total System 4.2 (28) 1.0 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Water 5.2 (28) 0.6 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Sediment 9.5 (28) 1.6 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Total System 2.4 (14) 0.5 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 1.3 (28) nd (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 2.7 (28) 0.5 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System

### 132 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 2.1 (7) 1.2 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Water 3.8 (99) 3.8 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 5.0 (99) 5.0 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Total System

Terrestrial Field Dissipation 1.5 (51) 0.2 (443) France

- Loam 49011260 0.9 (104) 0.3 (427) Germany

– Loamy sand 49011261 1.2 (153) 0.4 (538) UK

– Sandy clay loam 49011268 0.2 (178) 0.2 (253) Spain

– Sandy loam 49011269 1.8 (100) <0.1 (403) NY, USA

– Loam 49011263 0.8 (100) 0.2 (202) TX, USA

– Sandy clay loam 49011267 2.6 (29) 0.4 (295) FL, USA

- Sand 49011266 0.5 (99) 0.3 (251) CA, USA

- Loam 49011259 3.2 (328) 0.2 (741) MB, CAN

- Loam 49011264 3.4 (308) 0.7 (719) BC, CAN

– Sandy loam 49011265
IN

- E8S72

CAS: 5

- (Trifluoromethyl)

- 1 H

- pyrazole

- 3

- carboxylic acid ; CAS Number: 129768

- 28

- 1; Formula: C 5 H 3 F 3 N 2 O 2 ; MW: 150.10 g/mole ; Water solubility: 28.24 g/L; Log K OW =

- 0.52

Aerobic Soil 6.7 (120) 6.7 (120) Loamy sand

– [pyrazole

- 5

- 14 C] 49011155 6.3 (60) 1.9 (120) Sandy loam soil

– [pyrazole

- 5

- 14 C]

49011251 4.9 (30) 4.1 (120) Silty clay loam

– [pyrazole

- 5

- 14 C] 4.3 (60) 1.9 (190) Clay loam

– [pyrazole

- 5

- 14 C] 4.6 (60) 2.0 (120) Sand

– [pyrazole

- 5

- 14 C]

Anaerobic Soil 4.9 (120) 4.9 (120) Sandy loam

– [pyrazole

- 5

- 14C] 49011252 Soil Photolysis 6.4 (15) 6.4 (15) Sand

– [pyrazole

- 5

- 14 C] 49011253

Terrestrial Field Dissipation 7.2 (205) 0.7 (443) France

- Loam 49011260 10.1 (300) 4.8 (427) Germany

– Loamy sand 49011261 5.8 (153) 2.8 (538) UK

– Sandy clay loam 49011268 6.6 (15) 1.6 (253) Spain

– Sandy loam 49011269 3.5 (100) 0.3 (403) NY, USA

– Loam 49011263 11.5 (52) 4.2 (202) TX, USA

– Sandy clay loam 49011267 7.3 (328) 0.7 (741) MB, CAN

- Loam 49011264 6.4 (224) 2.0 (719) BC, CAN

– Sandy loam 49011265
IN

- P3X26

CAS: 2

- [1

- [2

- [5

- Methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl]acetyl]

- 4

- piperidinyl]

- 4

- thiazolecarboxylic acid Formula: C 16 H 17 F 3 N 4 O 3 S ; MW: 402.40 g/mole ; Log K OW : 0.25

### 133 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final

Aqueous Photolysis 10.8 (15) 10.8 (15) pH 7

– [pyrazole

- 5

- 14 C]

49011122 14.0 (15) 14.0 (15) pH 7

– [thiazole

- 5

- 14 C] 7.6 (15) 7.6 (15) N atural water

– [pyrazole

- 5

- 14 C] 6.3 (15) 6.3 (15) N atural water

– [thiazole

- 5

- 14 C]

IN

- RYJ52 (combined isomers IN

- RYJ52

- I1 plus IN

- RYJ52

- I2)

CAS: 1

- [4

- [4

- [(1 S ,3 S )

- 3

- (2,6

- Difluorophenyl)

- 1,3

- dihydroxypropyl]

- 2

- thiazolyl]

- 1

- piperindyl]

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1 H

- pyrazol

- 1

- yl]ethanone ; Formula: C 24 H 25 F 5 N 4 O 3 S ; MW: 544.55 g/mole ; IN

- RYJ52

- I1 Log K OW : 2.13; IN

- RYJ52

- I2 Log K OW : 2.24

Aerobic Aquatic 1.58 (60) 1.1 (90) Loamy sand

– [pyrazole

- 5

- 14 C]

– Water

49011279 6.2 (99) 6.2 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Sediment 7.3 (99) 7.3 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Total System 0.4 (60) nd Loamy sand

– [thiazole

- 5

- 14 C]

– Water 3.8 (28) 2.5 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Sediment 3.8 (28) 2.5 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Total System 6.1 (60) nd Silt loam

– [pyrazole

- 5

- 14 C]

– Water 9.9 (60) 8.1 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 16.0 (60) 8.1 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 3.4 (28) 0.3 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Water 8.8 (28) 2.7 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 12.2 (28) 3.0 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Total System

Anaerobic Aquatic 12.5 (60) 11.1 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011280 9.2 (100) 9.2 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 21.2 (60) 20.3 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 11.5 (100) 11.5 (100) Sand

– [thiazole

- 5

- 14 C]

– Water 9.2 (100) 9.2 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment 20.7 (100) 20.7 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System 9.3 (100) 9.3 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 18.6 (100) 18.6 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 27.9 (100) 27.9 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 9.2 (100) 9.2 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 20.6 (100) 20.5 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 29.9 (100) 29.9 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System 6.0 (100) 6.0 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011281 5.4 (100) 5.4 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 11.4 (100) 11.4 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 5.5 (100) 5.5 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Water

### 134 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 5.4 (100) 5.4 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Sediment
10.9 (100) 10.9 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Total System 9.9 (100) 9.9 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 22.8 (100) 22.8 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment
32.7 (100) 32.7 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System
10.3 (100) 10.3 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Water 20.8 (100) 20.8 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Sediment
31.0 (100) 31.0 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Total System

IN

- S2K66

CAS: 1

- [4

- [4

- [3

- (2,6

- Difluorophenyl)

- 1

- hydroxypropyl]

- 2

- thiazolyl]

- 1

- piperidinyl]

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1 H

- pyrazol

- 1yl]ethanone ; Formula: C 24 H 25 F 5 N 4 O 2 S ; MW: 528.55 g/mole ; Log K OW : 3.41

Aerobic Aquatic nd nd Loamy sand

– [pyrazole

- 5

- 14 C]

– Water

49011279 8.7 (99) 8.7 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Sediment 8.7 (99) 8.7 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Total System nd nd Loamy sand

– [thiazole

- 5

- 14 C]

– Water 1.5 (99) 1.5 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Sediment 1.5 (99) 1.5 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Total System nd nd Silt loam

– [pyrazole

- 5

- 14 C]

– Water 2.8 (60) 2.1 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 2.8 (60) 2.1 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System
nd nd Silt loam

– [thiazole

- 5

- 14 C]

– Water
nd nd Silt loam

– [thiazole

- 5

- 14 C]

– Sediment
nd nd Silt loam

– [thiazole

- 5

- 14 C]

– Total System

Anaerobic Aquatic 2.6 (100) 2.6 (100) Sand

– [thiazole

- 5

- 14 C]

– Water

49011280 8.6 (100) 8.6 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment
11.2 (100) 11.2 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System 1.2 (100) 1.2 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 9.0 (100) 9.0 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment
10.1 (100) 10.1 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 1.4 (100) 1.4 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 9.8 (100) 9.8 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment
11.1 (100) 11.1 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System 2.7 (100) 2.7 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011281 8.7 (100) 8.7 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment
11.4 (100) 11.4 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 2.2 (100) 2.2 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Water 8.0 (100) 8.0 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Sediment
10.2 (100) 10.2 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Total System 3.2 (2) 1.4 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 11.6 (100) 11.6 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment
13.0 (100) 13.0 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 0.9 (0) 0.9 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Water 9.9 (100) 9.9 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Sediment

### 135 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 10.7 (100) 10.7 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Total System

Aerobic Soil 1.7 (90) 1.5 (120) Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 1.5 (60) 1.1 (120) Loamy sand

– [thiazole

- 5

- 14 C] 1.6 (120) 1.4 (134) Loamy sand

– [isoxazoline

- 5

- 14 C]
49011155 1.6 (120) 1.6 (120) Loamy sand

– [pyrazole

- 5

- 14 C] 1.2 (120) 1.2 (120) Sandy loam soil

– [pyrazole

- 5

- 14 C]

49011251 <LOQ (120) <LOQ (120) Sandy loam

– [thiazole

- 5

- 14 C] 1.5 (15) 1.3 (120) Silty clay loam

– [pyrazole

- 5

- 14 C] 2.5 (90) 2.5 (120) Silty clay loam

– [thiazole

- 5

- 14 C] 1.3 (90) 1.3 (120) Clay loam

– [pyrazole

- 5

- 14 C] 1.3 (90) <LOQ (120) Clay loam

– [thiazole

- 5

- 14 C] 1.5 (60) 1.4 (120) Sand

– [pyrazole

- 5

- 14 C]

<LOQ (120) <LOQ (120) Sand

– [thiazole

- 5

- 14 C]

Aerobic Aquatic 1.5 (99) 1.5 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Water

49011279 4.1 (99) 4.1 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Sediment 5.6 (99) 5.6 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Total System 1.3 (99) 1.3 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Water 10.5 (99) 10.5 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Sediment
11.8 (99) 11.8 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Total System 0.5 (7) 0.3 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 7.5 (99) 7.5 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 7.7 (99) 7.5 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 0.6 (14) nd (99) Silt loam

– [thiazole

- 5

- 14 C]

– Water 9.1 (60) 3.2 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 9.1 (60) 3.2 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Total System

Anaerobic Aquatic 1.1 (28) 0.9 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011280 4.5 (100) 4.5 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 5.4 (100) 5.4 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 1.4 (60) 0.8 (100) Sand

– [thiazole

- 5

- 14 C]

– Water 3.5 (100) 3.5 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment 4.3 (100) 4.3 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System 0.9 (100) 0.9 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 4.3 (100) 4.3 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 5.2 (100) 5.2 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 0.7 (60) 0.2 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 4.3 (100) 4.3 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 4.5 (100) 4.5 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System 1.0 (100) 1.0 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011281 6.1 (100) 6.1 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 7.0 (100) 7.0 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 1.2 (60) 0.6 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Water 6.9 (60) 7.1 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Sediment 8.0 (60) 7.7 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Total System 0.5 (100) 0.5 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 5.1 (60) 5.0 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 5.1 (60) 5.4 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 0.8 (100) 0.8 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Water 5.8 (100) 5.8 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Sediment 6.6 (100) 6.6 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Total System

### 136 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final IN

- Q7D41

CAS: 1

- [4

- [4

- [5

- (2,6

- Difluorophenyl)

- 3

- isoxazolyl]

- 2

- thiazolyl]

- 1

- piperidinyl]

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1 H

- pyrazol

- 1

- yl]ethanone ; CAS Number: 1148046

- 53

- 0 ; Formula: C 24 H 20 F 5 N 5 O 2 S
MW: 537.13 g/mole ; Water solubility: n/a; Log K OW : 4.31; S MILES: CC1=CC(=NN 1CC(=O)N1CCC(CC1)C1=NC(=CS1)C1=NOC(=C1)C1=C(F)C=CC=C1F)C(F)(F)F

Aerobic Soil 1.7 (90) 1.5 (120) Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 1.5 (60) 1.1 (120) Loamy sand

– [thiazole

- 5

- 14 C] 1.6 (120) 1.4 (134) Loamy sand

– [isoxazoline

- 5

- 14 C]
49011155 1.6 (120) 1.6 (120) Loamy sand

– [pyrazole

- 5

- 14 C] 1.2 (120) 1.2 (120) Sandy loam soil

– [pyrazole

- 5

- 14 C]

49011251 <LOQ (120) <LOQ (120) Sandy loam

– [thiazole

- 5

- 14 C] 1.5 (15) 1.3 (120) Silty clay loam

– [pyrazole

- 5

- 14 C] 2.5 (90) 2.5 (120) Silty clay loam

– [thiazole

- 5

- 14 C] 1.3 (90) 1.3 (120) Clay loam

– [pyrazole

- 5

- 14 C] 1.3 (90) <LOQ (120) Clay loam

– [thiazole

- 5

- 14 C] 1.5 (60) 1.4 (120) Sand

– [pyrazole

- 5

- 14 C]

<LOQ (120) <LOQ (120) Sand

– [thiazole

- 5

- 14 C]

A erobic Aquatic 1.5 (99) 1.5 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Water

49011279 4.1 (99) 4.1 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Sediment 5.6 (99) 5.6 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Total System 1.3 (99) 1.3 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Water 10.5 (99) 10.5 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Sediment 11.8 (99) 11.8 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Total System 0.5 (7) 0.3 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 7.5 (99) 7.5 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 7.7 (99) 7.5 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 0.6 (14) nd (99) Silt loam

– [thiazole

- 5

- 14 C]

– Water 9.1 (60) 3.2 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 9.1 (60) 3.2 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Total System

Anaerobic Aquatic 1.1 (28) 0.9 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011280 4.5 (100) 4.5 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 5.4 (100) 5.4 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 1.4 (60) 0.8 (100) Sand

– [thiazole

- 5

- 14 C]

– Water 3.5 (100) 3.5 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment 4.3 (100) 4.3 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System 0.9 (100) 0.9 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 4.3 (100) 4.3 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 5.2 (100) 5.2 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 0.7 (60) 0.2 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 4.3 (100) 4.3 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 4.5 (100) 4.5 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System

### 137 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 1.0 (100) 1.0 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011281 6.1 (100) 6.1 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 7.0 (100) 7.0 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 1.2 (60) 0.6 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Water 6.9 (60) 7.1 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Sediment 8.0 (60) 7.7 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Total System 0.5 (100) 0.5 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 5.1 (60) 5.0 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 5.1 (60) 5.4 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System

0.8 (100) 0.8 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Water

5.8 (100) 5.8 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Sediment
6.6 (100) 6.6 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Total System

IN

- QFD61

CAS: 1

- [4

- (4

- Acetyl

- 2

- thiazolyl)

- 1

- piperindyl]

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1 H

- pyrazol

- 1

- yl]ethanone CAS Number: 1152179

- 07

- 1 ; Formula: C 17 H 19 F 3 N 4 O 2 S
MW: 400.43 g/mole ; Log K OW : 2.05

Anaerobic Aquatic 16.8 (60) 10.5 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011280 3.4 (60) 2.1 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 20.2 (60) 12.6 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 15.6 (60) 9.8 (100) Sand

– [thiazole

- 5

- 14 C]

– Water 2.5 (100) 2.5 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment 17.6 (60) 12.2 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System 4.7 (100) 4.7 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 1.2 (28) 0.6 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 5.3 (100) 5.3 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 5.8 (100) 5.8 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 1.1 (28) 1.1 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 6.9 (100) 6.9 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System 8.8 (60) 5.8 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011281 2.5 (100) 2.5 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 10.2 (60) 8.3 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 6.4 (100) 6.4 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 1.7 (100) 1.7 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 8.1 (100) 8.1 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System
IN

- S2K67 O C H 3 S

N N

O N
N C H 3

F F F

### 138 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final

CAS: 1

- [4

- [4

- (1

- Hydroxyethyl)

- 2

- thiazolyl)

- 1

- piperindyl]

- 2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1 H

- pyrazol

- 1

- yl]ethanone CAS Number: N/A ; Formula: C 17 H 21 F 3 N 4 O 2 S
MW: 402.44 g/mole ; Log K OW : 1.56

Anaerobic Aquatic 8.7 (60) 3.7 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011280 4.9 (60) 2.6 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 13.6 (60) 6.3 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 5.4 (100) 5.4 (100) Sand

– [thiazole

- 5

- 14 C]

– Water 2.9 (100) 2.9 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment 8.3 (100) 8.3 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System 0.7 (60) 0.7 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 0.6 (60) 0.6 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 1.3 (60) 1.3 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 0.9 (100) 0.9 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 0.9 (100) 0.9 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 1.8 (100) 1.8 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System 5.7 (100) 5.7 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011281 3.6 (100) 3.6 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 9.3 (100) 9.3 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 1.1 (100) 1.1 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 1.2 (100) 1.2 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 2.4 (100) 2.4 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System

IN

- RSE01

CAS: 3

- (2.6

- Difluorophenyl)

- 3

- hydroxy

- 1

- [2

- [1

- [2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl]acetyl]

- 4

- piperidinyl]

- 4

- thiazolyl]

- 1

- propanone Formula: C 24 H 23 F 5 N 4 O 3 S
MW: 542.53 g/mole ; Log K OW : 2.78

Aerobic Aquatic 2.9 (7) 2.9 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Water

49011279 4.3 (99) 4.3 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Sediment 7.2 (99) 7.2 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Total System 3.6 (99) 3.6 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Water 5.2 (28) 2.4 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Sediment 7.2 (14) 6.0 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Total System 3.8 (60) 1.1 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Water O H

C H 3 S

N N

O N
N C H 3

F F F

O O H S

N N

O N
N C H 3

F F F F

F

### 139 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 8.6 (14) 5.5 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 10.4 (14) 6.6 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 2.9 (14) 0.1 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Water 7.8 (60) 3.2 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 9.6 (28) 3.3 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Total System

Anaerobic Aquatic 6.3 (28) 2.7 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011280 3.0 (100) 3.0 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 9.1 (28) 5.7 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 4.2 (60) 2.9 (100) Sand

– [thiazole

- 5

- 14 C]

– Water 2.8 (100) 2.8 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment 7.0 (60) 5.7 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System 3.4 (60) 2.8 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 6.1 (60) 3.8 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 9.6 (60) 6.7 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 3.2 (28) 0.9 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 6.3 (60) 3.5 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 8.8 (60) 4.5 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System 11.6 (30) 1.9 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011281 5.0 (30) 2.6 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 16.6 (30) 4.5 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 7.3 (30) 2.0 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Water 3.7 (60) 2.5 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Sediment 10.9 (30) 4.5 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Total System 3.3 (60) 1.1 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 5.6 (60) 3.0 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 8.9 (60) 4.0 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 3.9 (30) 2.6 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Water 6.0 (60) 3.7 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Sediment 9.9 (60) 6.3 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Total System

2,6

- DFBA / IN

- YY147

CAS: 2,6

- diflurobenzoic acid ; CAS Number: 385

- 00

- 2 ; Formula: C 7 H 4 F 2 O 2 ; MW: 158.11 g/mol e

Anaerobic Aquatic 15.5 (100) 15.5 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Water

49011281 2.7 (100) 2.7 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Sediment
18.2 (100) 18.2 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Total System 7.9 (100) 7.9 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Water 2.4 (100) 2.4 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Sediment
10.3 (100) 10.3 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

– Total System Minor Degr adates O H O F

F

### 140 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final IN

- QPS10

CAS: 4

- [4

- [5

- (2,6

- Difluorophenyl)

- 4,5

- dihydro

- 3

- isoxazolyl)

- 2

- thiazolyl]piperidine CAS Number: 1148104

- 71

- 5 Formula: C 17 H 17 F 2 N 3 OS
MW: 349.41 g/mole Log K OW :

- 2.02

Aerobic Soil NA NA Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 7.2 (90) 3.9 (120) Loamy sand

– [thiazole

- 5

- 14 C] 2.9 (90) 1.2 (134) Loamy sand

– [isoxazoline

- 5

- 14 C] 49011155

<LOQ (120) <LOQ (120) Sandy loam

– [thiazole

- 5

- 14 C]

49011251 8.7 (60) 6.3 (120) Silty clay loam

– [thiazole

- 5

- 14 C] 3.2 (120) 3.2 (120) Clay loam

– [thiazole

- 5

- 14 C] 2.7 (90) <LOQ (120) Sand

– [thiazole

- 5

- 14 C]
Anaerobic Soil 1.9 (30) nd Sandy loam

– [isoxazoline

- 5

- 14 C] 49011252

Terrestrial Field Dissipation 0.5 (205) 0.1 (443) France

- Loam 49011260 nd (427) nd (427) Germany

– Loamy sand 49011261 0.3 (153) nd (538) UK

– Sandy clay loam 49011268 nd (253) nd (253) Spain

– Sandy loam 49011269 0.4 (403) 0.4 (403) NY, USA

– Loam 49011263 <0.1 (30) nd (202) TX, USA

– Sandy clay loam 49011267 0.8 (203) 0.4 (295) FL, USA

- Sand 49011266 0.1 (99) 0.1 (251) CA, USA

- Loam 49011259 0.2 (328) <0.1 (741 ) MB, CAN

- Loam 49011264 0.2 (308) 0.1 (719) BC, CAN

– Sandy loam 49011265

IN

- WR791

CAS: 5

- Methyl

- 3

- (trifluoromethyl)

- 1 H

- pyrazole

- 1

- acetic acid CAS Number: 345637

- 71

- 0 ; Formula: C 7 H 7 F 3 N 2 O 2 ; MW: 208.14 g/mole
Aerobic soil Observed but not quantified Anaerobic Soil Soil Photolysis IN

- RLD51 O H

O N
N C H 3

F F F

### 141 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final

CAS: 1

- [2

- [5

- Methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl]acetyl]

- 4

- piperidinecarboxylic acid CAS Number: 922516

- 34

- 5
Formula: 

### C 13 

### H 16 

### F 3 

### N 3 

### O 3 MW: 319.29 g/mole

Aerobic Soil 2.8 (60) 1.7 (120) Sandy loam soil

– [pyrazole

- 5

- 14 C]

49011251 3.6 (60) <LOQ (120) Silty clay loam

– [pyrazole

- 5

- 14 C] 2.6 (120) 2.6 (120) Clay loam

– [pyrazole

- 5

- 14 C] 3.3 (120) 3.3 (120) Sand

– [pyrazole

- 5

- 14 C]

Soil Photolysis 2.8 (10) nd Sand

– [pyrazole

- 5

- 14 C]
49011253 0.6 (7) nd Sand

– [isoxazoline

- 5

- 14 C]
Aqueous photolysis 5.4 (6) 3.7 (15) pH 7

– [pyrazole

- 5

- 14 C] 49011122
IN

- RSA90

CAS: 1

- [2

- (5

- methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl)acetyl]

- 4

- piperidinecarboxamide
Formula: 

### C 13 

### H 17 

### F 3 

### N 4 

### O 2 MW: 318.30 g/mole
Soil Photolysis 3.2 (10) 1.2 (15) Sand

– [pyrazole

- 5

- 14 C] 49011253
Aqueous Photolysis 5.2 (15) 5.2 (15) pH 7

– [pyrazole

- 5

- 14 C] 49011122

IN

- RBR89

CAS: 3

- (2,6

- Difluorophenyl)

- 1

- [2

- [1

- [2

- [5

- methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 1

- yl]acetyl]

- 4

- piperidinyl]

- 4

- thiazolyl)

- 2

- propen

- 1

- one ; Formula: C 24 H 2 1 F 5 N 4 O 2 S ; MW: 524.52 g/mole

.

Anaerobic Aquatic 0.8 (60) 0.3 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011280 1.5 (100) 1.5 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 2.0 (60) 1.8 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 0.4 (100) 0.4 (100) Sand

– [thiazole

- 5

- 14 C]

– Water 1.7 (100) 1.7 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment O H

O N

O N
N C H 3

F F F

N H 2
O N

O N
N C H 3

F F F

O S

N N

O N
N C H 3

F F F F

F

### 142 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 2.1 (100) 2.1 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System
nd nd Silt loam

– [pyrazole

- 5

- 14 C]

– Water 2.3 (100) 2.3 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 2.3 (100) 2.3 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 0.3 (100) 0.3 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 1.7 (100) 1.7 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 2.0 (100) 2.0 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System Other Degradates: CO 2

Aerobic Soil 0.33 (120) 0.33 (120) Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 11.8 (120) 11.8 (120) Loamy sand

– [thiazole

- 5

- 14 C] 5.0 (134) 5.0 (134) Loamy sand

– [isoxazoline

- 5

- 14 C]
49011155 6.6 (120) 6.6 (120) Loamy sand

– [pyrazole

- 5

- 14 C]

<LOQ (120) <LOQ (120) Sandy loam soil

– [pyrazole

- 5

- 14 C]

49011251 <LOQ (120) <LOQ (120) Sandy loam

– [thiazole

- 5

- 14 C]

<LOQ (120) <LOQ (120) Silty clay loam

– [pyrazole

- 5

- 14 C]

0.4 (60) 0.4 (120) Silty clay loam

– [thiazole

- 5

- 14 C]

<LOQ (120) <LOQ (120) Clay loam

– [pyrazole

- 5

- 14 C]

<LOQ (120) <LOQ (120) Clay loam

– [thiazole

- 5

- 14 C]

<LOQ (120) <LOQ (120) Sand

– [pyrazole

- 5

- 14 C]

<LOQ (120) <LOQ (120) Sand

– [thiazole

- 5

- 14 C]

Anaerobic Soil 1.5 (30) 1.5 (120) Sandy loam

– [pyrazole

- 5

- 14C]
49011252 3.0 (60) 3.0 (120) Sandy loam

– [isoxazoline

- 5

- 14 C]

Soil Photolysis <LOQ (15) <LOQ (15) Sand

– [pyrazole

- 5

- 14 C]
49011253 <LOQ (15) <LOQ (15) Sand

– [isoxazoline

- 5

- 14 C]

Aerobic Aquatic 0.2 (99) 0.2 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

49011279 7.2 (99) 7.2 (99) Loamy sand

– [thiazole

- 5

- 14 C] 0.4 (60) 0.4 (99) Silt loam

– [pyrazole

- 5

- 14 C] 6.8 (99) 6.8 (99) Silt loam

– [thiazole

- 5

- 14 C]

Anaerobic Aquatic <LOQ (100) <LOQ (100) Sand

– [pyrazole

- 5

- 14 C]

49011280 <LOQ (100) <LOQ (100) Sand

– [thiazole

- 5

- 14 C]

<LOQ (100) <LOQ (100) Silt loam

– [pyrazole

- 5

- 14 C] 0.1 (100) 0.1 (100) Silt loam

– [thiazole

- 5

- 14 C]

<LOQ (100) <LOQ (100) Sand

– [pyrazole

- 5

- 14 C]

49011281 0.3 (100) 0.3 (100) Sand

– [isoxazoline

- 5

- 14 C]

<LOQ (100) <LOQ (100) Silt loam

– [pyrazole

- 5

- 14 C] 0.7 (100) 0.7 (100) Silt loam

– [isoxazoline

- 5

- 14 C]

Unidentified polar radioactivity 2

Aerobic Soil 3.6 (120) 3.6 (120) Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 NA NA Loamy sand

– [thiazole

- 5

- 14 C]
Aqueous Photo. 10.2 (15) 10.2 (15) pH 7

– [isoxazoline

- 5

- 14 C] 49011122

Aerobic Aquatic 14.6 (99) 14.6 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Water

49011279 5.9 (60) 5.8 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Sediment

20.4 (99) 20.4 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Total System 12.3 (99) 12.3 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Water 9.5 (28) 4.2 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Sediment

16.5 (99) 16.5 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Total System

### 143 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 13.7 (99) 13.7 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 6.0 (99) 6.0 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 19.8 (99) 19.8 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 1.3 (60) 1.3 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Water 6.9 (28) 5.4 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 8.0 (28) 6.6 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Total System

Unidentified non

- polar radioactivity 2

Aerobic Soil 25.9 (120) 25.9 (120) Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 NA NA Loamy sand

– [thiazole

- 5

- 14 C] Aqueous Photo. 22.4 (15) 22.4 (15) pH 7

– [isoxazoline

- 5

- 14 C] 49011122

Aerobic Aquatic 9.2 (99) 9.2 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Water

49011279 10.1 (99) 10.1 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Sediment 19.3 (99) 19.3 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

– Total System 6.3 (28) 5.8 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Water 11.3 (99) 11.3 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Sediment 17.1 (99) 17.1 (99) Loamy sand

– [thiazole

- 5

- 14 C]

– Total System 7.3 (14) 4.9 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 9.6 (60) 6.5 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 15.1 (60) 11.4 (99) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 6.7 (60) 1.9 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Water 6.5 (99) 6.5 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 9.6 (28) 8.4 (99) Silt loam

– [thiazole

- 5

- 14 C]

– Total System

Unidentified radioactivity 2

Aerobic Soil NA NA Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 18.8 (90) 14.9 (120) Loamy sand

– [thiazole

- 5

- 14 C] 6.2 (134) 6.2 (134) Loamy sand

– [isoxazoline

- 5

- 14 C]
49011155 12.3 (120) 12.3 (120) Loamy sand

– [pyrazole

- 5

- 14 C] 19.9 (60) 10.1 (120) Sandy loam soil

– [pyrazole

- 5

- 14 C]

49011251 13.1 (30) 10.3 (120) Sandy loam

– [thiazole

- 5

- 14 C] 25.8 (90) 14.9 (120) Silty clay loam

– [pyrazole

- 5

- 14 C] 22.5 (90) 20.9 (120) Silty clay loam

– [thiazole

- 5

- 14 C] 22.8 (120) 22.8 (120) Clay loam

– [pyrazole

- 5

- 14 C] 27.8 (90) 17.9 (120) Clay loam

– [thiazole

- 5

- 14 C] 22.1 (90) 18.6 (120) Sand

– [pyrazole

- 5

- 14 C]

23.8 (90) 9.4 (120) Sand

– [thiazole

- 5

- 14 C]

Anaerobic Soil 14.9 (120) 14.9 (120) Sandy loam

– [pyrazole

- 5

- 14C]
49011252 9.0 (90) 7.3 (120) Sandy loam

– [isoxazoline

- 5

- 14 C]

Soil Photolysis 7.9 (10) 5.9 (15) Sand

– [pyrazole

- 5

- 14 C]
49011253 8.9 (15) 8.9 (15) Sand

– [isoxazoline

- 5

- 14 C]

Aqueous Photolysis 31.3 (15) 31.3 (15) pH 7

– [pyrazole

- 5

- 14 C]

49011122 31.6 (6) 30.3 (15) pH 7

– [thiazole

- 5

- 14 C] 33.3 (15) 33.3 (15) natural water

– [pyrazole

- 5

- 14 C] 39.3 (15) 39.3 (15) natural water

– [thiazole

- 5

- 14 C]

Anaerobic Aquatic 1.6 (100) 1.6 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water
49011280 1.0 (100) 1.0 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment

### 144 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final 1.6 (60) 2.5 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 2.5 (100) 2.5 (100) Sand

– [thiazole

- 5

- 14 C]

– Water 1.9 (100) 1.9 (100) Sand

– [thiazole

- 5

- 14 C]

– Sediment 4.4 (100) 4.4 (100) Sand

– [thiazole

- 5

- 14 C]

– Total System 2.8 (100) 2.8 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 1.7 (100) 1.7 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 4.5 (100) 4.5 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 2.0 (100) 2.0 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Water 1.2 (100) 1.2 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Sediment 3.2 (100) 3.2 (100) Silt loam

– [thiazole

- 5

- 14 C]

– Total System 1.4 (0) 1.3 (100) Sand

– [pyrazole

- 5

- 14 C]

– Water

49011281 0.7 (100) 0.7 (100) Sand

– [pyrazole

- 5

- 14 C]

– Sediment 2.0 (100) 2.0 (100) Sand

– [pyrazole

- 5

- 14 C]

– Total System 1.5 (2) 1.3 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Water 1.9 (60) nd Sand

– [isoxazoline

- 5

- 14 C]

– Sediment 3.6 (60) 1.3 (100) Sand

– [isoxazoline

- 5

- 14 C]

– Total System 2.4 (0) 2.0 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Water 2.6 (0) 2.1 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Sediment 5.0 (0) 4.2 (100) Silt loam

– [pyrazole

- 5

- 14 C]

– Total System 2.0 (60) nd Silt loam

– [isoxazoline

- 5

- 14 C]

– Water 0.14 (14) nd Silt loam

– [isoxazoline

- 5

- 14 C]

– Sediment 2.0 (60) nd Silt loam

– [isoxazoline

- 5

- 14 C]

– Total System Un

- extracted Residues

Aerobic Soil 11.2 (120) 11.2 (120) Loamy sand

– [pyrazole

- 5

- 14 C]
49011250 24.5 (90) 17.9 (120) Loamy sand

– [thiazole

- 5

- 14 C] 9.4 (90) 8.1 (134) Loamy sand

– [isoxazoline

- 5

- 14 C]
49011155 9.9 (120) 9.9 (120) Loamy sand

– [pyrazole

- 5

- 14 C] 19.9 (120) 19.9 (120) Sandy loam soil

– [pyrazole

- 5

- 14 C]

49011251 14.5 (120) 14.5 (120) Sandy loam

– [thiazole

- 5

- 14 C] 21.8 (120) 21.8 (120) Silty clay loam

– [pyrazole

- 5

- 14 C] 42.9 (60) 38.2 (120) Silty clay loam

– [thiazole

- 5

- 14 C] 34.2 (120) 34.2 (120) Clay loam

– [pyrazole

- 5

- 14 C] 36.7 (90) 36.5 (120 ) Clay loam

– [thiazole

- 5

- 14 C] 12.6 (120) 12.6 (120) Sand

– [pyrazole

- 5

- 14 C] 13.2 (90) 6.7 (120) Sand

– [thiazole

- 5

- 14 C]

Anaerobic Soil 5.9 (120) 5.9 (120) Sandy loam

– [pyrazole

- 5

- 14C]
49011252 7.7 (30) 7.7 (30) Sandy loam

– [isoxazoline

- 5

- 14 C]

Soil Photolysis 7.6 (15) 7.6 (15) Sand

– [pyrazole

- 5

- 14 C]
49011253 8.1 (15) 8.1 (15) Sand

– [isoxazoline

- 5

- 14 C]

Aerobic Aquatic 7.3 (99) 7.3 (99) Loamy sand

– [pyrazole

- 5

- 14 C]

49011279 12.4 (60) 11.7 (99) Loamy sand

– [thiazole

- 5

- 14 C] 13.5 (99) 13.5 (99) Silt loam

– [pyrazole

- 5

- 14 C] 16.6 (99) 16.6 (99) Silt loam

– [thiazole

- 5

- 14 C]

Anaerobic Aquatic 5.1 (100) 5.1 (100) Sand

– [pyrazole

- 5

- 14 C]

49011280 3.9 (100) 3.9 (100) Sand

– [thiazole

- 5

- 14 C] 5.0 (100) 5.0 (100) Silt loam

– [pyrazole

- 5

- 14 C] 5.4 (100) 5.4 (100) Silt loam

– [thiazole

- 5

- 14 C] 4.2 (100) 4.2 (100) Sand

– [pyrazole

- 5

- 14 C]

### 145 Compound Study Type AR% (Sampling Interval)
Comment MRID Max imum Final

Anaerobic Aquatic 3.1 (100) 3.1 (100) Sand

– [isoxazoline

- 5

- 14 C]

49011281 5.0 (100) 5.0 (100) Silt loam

– [pyrazole

- 5

- 14 C] 5.5 (100) 5.5 (100) Silt loam

– [isoxazoline

- 5

- 14 C] D=day; h=hour; NA =not analyzed; ND =not detected; AR=applied radioactivity; Mean values reported rather than the maximum individual values; Physical

- chemical parameters of oxathiapiprolin and transformation parameters obtained from PMRA CES review Vol. 3, Annex B, B.2 Physical and chemical properties (PMRA No. 2417944).

1 Maximum amounts of organic volatiles were minimal in all studies (<0.1%AR).

2 Consists of multiple co mponents, none of which exceeded 5% at two consecutive sampling intervals, w ere greater than 10% at any sampling interval, or w ere increasing at the end of the study.

### 146 Appendix 2 

## Appendix B. Output of STIR Results Input

Application and Chemical Information

Enter Chemical Name Oxathiapiprolin

Enter Chemical Use Various Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air Enter Chemical Molecular Weight (g/mole) 540 Enter Chemical Vapor Pressure (mmHg) 8.56E

- 09 Enter Application Rate (lb a.i./acre) 0.25

Toxicity Properties

**Bird**

Enter Lowest Bird Oral LD 50 (mg/kg bw) 2250 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178
**Mammal**
Enter Lowest Rat Oral LD 50 (mg/kg bw) 5000
Enter Lowest Rat Inhalation LC 50 (mg/L) 5.1 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35 Output

Results Avian (0.020 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.49E

- 04

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 3.13E

- 05 Adjusted Inhalation LD 50 1.28E+01 Ratio of Vapor Dose to Adjusted Inhalation LD 50 2.44E

- 06 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.40E

- 02

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 1.88E

- 03 Exposure not Likely Significant

Results Mammalian (0.015 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.49E

- 04

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 3.93E

- 05 Adjusted Inhalation LD 50 3.04E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.29E

- 07 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 3.02E

- 02

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 9.94E

- 05 Exposure not Likely Significant

### 147 ndix 3 

## Appendix C. Output of SIP Results

Table 1. Inputs

Parameter Value

Chemical name Oxathiapiprolin
Solubility (in water at 25 o C; mg/L) 0.21

Mammalian LD 50 (mg/kg

- bw) 5000 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 1000 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg

- bw) 2250 Avian test species mallard duck Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) 920 Bobwhite quail NOAEC (mg/kg

- diet) 1230 NOAEC (mg/kg

- diet) for other bird species Body weight (g) of other avian species NOAEC (mg/kg

- diet) for 2nd other bird species Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 0.0361 0.0361 Adjusted toxicity value (mg/kg

- bw) 3845.8028 769.1606 Ratio of exposure to toxicity 0.0000 0.0000

Conclusion* Drinking water exposure alone is NOT a potential concern for
mammals Drinking water exposure alone is NOT a potential concern for
mammals

Table 3. Avian Results

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 0.1701 0.1701 Adjusted toxicity value (mg/kg

- bw) 1168.2572 45.6436 Ratio of exposure to acute toxicity 0.0001 0.0037

Conclusion* Drinking water exposure alone is NOT a potential concern for birds Drinking water exposure alone is NOT a potential concern for birds

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when aggrega ted with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non

- target animals.

### 148 Appendix 4 

## Appendix D. Sample Output of T

- REX Results

Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Oxathiapiprolin

Use Ginseng

Formulation 0 Application Rate 0.25 lbs a.i./acre

Half

- life 35 days Application Interval 14 days Maximum # Apps./Year 2 Length of Simulation 1 year Variable application rates? no

Endpoints

Avian Bobwhite quail LD50 (mg/kg

- bw) 2250.00

Bobwhite quail LC50 (mg/kg

- diet) 5640.00

Mallard duck NOAEL(mg/kg

- bw) 0.00

Mallard duck NOAEC (mg/kg

- diet) 920.00

Mammals LD50 (mg/kg

- bw) 5000.00 LC50 (mg/kg

- diet) 0.00 NOAEL (mg/kg

- bw) 1210.00 NOAEC (mg/kg

- diet) 17000.00

Dietary

- based EECs (ppm) Kenaga
Values
Short Grass 105.47
Tall Grass 48.34 Broadleaf plants 59.33 Fruits/pods/seeds 6.59 Arthropods 41.31

### 149 Avian Results

Avian Body Ingestion (Fdry) Ingestion (Fwet) % body wgt FI

Class Weight (g) (g bw/day) (g/day) consumed (kg

diet/day)

Small 20 5 23 114 2.28E

- 02

Mid 100 13 65 65 6.49E

- 02 Large 1000 58 291 29 2.91E

- 01

20 5 5 25 5.06E

- 03 Granivore

s 100 13 14 14 1.44E

- 02

1000 58 65 6 6.46E

- 02

Avian Body Adjusted LD50 Weight (g) (mg/kg

- bw)
20 1620.97
100 2063.57
1000 2914.87

Dose

- based EECs (mg/kg

- bw) Avian Classes and Body Weights (grams)

small mid large

20 100 1000
Short Grass 120.12 68.50 30.67
Tall Grass 55.06 31.40 14.06 Broadleaf plants 67.57 38.53 17.25 Fruits/pods 7.51 4.28 1.92 Arthropods 47.05 26.83 12.01
Seeds 1.67 0.95 0.43



# Dose

- based RQs
(Dose

- based EEC/adjusted LD50) Avian Acute RQs Size Class (grams)

20 100 1000

Short Grass 0.07 0.03 0.01
Tall Grass 0.03 0.02 0.00 Broadleaf plants 0.04 0.02 0.01 Fruits/pods 0.00 0.00 0.00 Arthropods 0.03 0.01 0.00 Seeds 0.00 0.00 0.00

### 150 

# Dietary

- based RQs
(Dietary

- based EEC/LC50 or NOAEC) RQs

Acute Chronic

Short Grass 0.02 0.11
Tall Grass 0.01 0.05 Broadleaf plants 0.01 0.06 Fruits/pods/seeds 0.00 0.01 Arthropods 0.01 0.04

Oxathiapiprolin Ginseng Upper bound Kenaga Residues
Mammalian Results

Mammalia

n Body Ingestion (Fdry) Ingestion (Fwet) % body wgt FI

Class Weigh
t (g bwt/day) (g/day) consumed (kg

diet/day)
15 3 14 95 1.43E

- 02 Herbivores / 35 5 23 66 2.31E

- 02 insectivore

s 1000 31 153 15 1.53E

- 01
15 3 3 21 3.18E

- 03
Grainvores 35 5 5 15 5.13E

- 03
1000 31 34 3 3.40E

- 02

Mammalia

n Body Adjusted Adjusted

Class Weigh
t LD50 NOAEL
15 10989.15 2659.37 Herbivores / 35 8891.40 2151.72 insectivore

s 1000 3845.80 930.68
15 10989.15 2659.37
Granivores 35 8891.40 2151.72

1000 3845.80 930.68

### 151 Dose

- Based EECs (mg/kg

- bw) Mammalian Classes and Body weight (grams)

15 35 1000

Short Grass 100.56 69.50 16.11
Tall Grass 46.09 31.85 7.39 Broadleaf plants 56.56 39.09 9.06 Fruits/pods 6.28 4.34 1.01 Arthropods 39.39 27.22 6.31
Seeds 1.40 0.97 0.22

Dose

- based RQs (Dose

based EEC/LD50 or NOAEL) Small mammal Medium mammal Large mammal

15 grams 35 grams 1000 grams

Acute Chr onic Acute Chronic Acute Chronic

Short Grass 0.01 0.04 0.01 0.03 0.00 0.02
Tall Grass 0.00 0.02 0.00 0.01 0.00 0.01 Broadleaf plants 0.01 0.02 0.00 0.02 0.00 0.01 Fruits/pods 0.00 0.00 0.00 0.00 0.00 0.00 Arthropods 0.00 0.01 0.00 0.01 0.00 0.01
Seeds 0.00 0.00 0.00 0.00 0.00 0.00

Dietary

- based RQs (Dietary

- based EEC/LC50 or NOAEC) Mammal RQs

Acute Chronic

Short Grass #DIV/0! 0.01
Tall Grass #DIV/0! 0.00 Broadleaf plants #DIV/0! 0.00 Fruits/pods/seeds #DIV/0! 0.00 Arthropods #DIV/0! 0.00

### 152 

## 5 Appendix E. Sample Ouput of KABAM Results

Characteristic Value Comments/Guidance

Pesticide Name Oxathiapiprolin Required input

Log K OW 3.6 Required input Enter value from acceptable or supplemental study submitted by registrant or available in scientific literature.

K OW 3981 No input necessary. This value is calculated automatically from the Log K OW value entered above.

K OC (L/kg OC) 12810 Required input Input value used in PRZM/EXAMS to derive EECs. Follow input parameter guidance for deriving this parameter value (USEPA 2002).

Time to steady state (T S ; days) 3 No input necessary. This value is calculated automatically from the Log K OW value entered above.

Pore water EEC (μg/L) 0.741 Required input Enter value generated by PRZM/EXAMS benthic file. PRZM/EXAMS EEC represents the freely dissolved concentration of the pesticide in the pore water of the sediment. The appropriate averaging period of the EEC is dependent on the specific pesticide being mod eled and is based on the time it takes for the chemical to reach steady state. Select the EEC generated by PRZM/EXAMS which has an averaging period closest to the time to steady state calculated above. In cases where the time to steady state exceeds 365 d ays, the user should select the EEC representing the average of yearly averages. The peak EEC should not be used.

Water Column EEC (μg/L) 2.79 Required input Enter value generated by PRZM/EXAMS water column file. PRZM/EXAMS EEC represents the freely dissolved concentration of the pesticide in the water column. The appropriate averaging period of the EEC is dependent on the specific pesticide being modeled and is based on the time it takes for the chemical to reach steady state. The averaging period used for the water column EEC should be the same as the one selected for the pore water EEC (discussed above).

### 153 Table 14. Calculation of EECs for mammals and birds consuming fish contaminated by Oxathiapiprolin. Wildlife Species Biological Parameters EECs (pesticide intake) Body Weight

(kg) Dry Food Ingestion Rate (kg

dry food/kg

bw/day) Wet Food Ingestion Rate (kg

wet food/kg

bw/day) Drinking Water Intake (L/d) Dose Based (mg/kg

bw/d) Dietary Based (ppm)

Mammalian

fog/water shrew 0.02 0.140 0.585 0.003 0.236 0.40

rice rat/star

nosed mole 0.1 0.107 0.484 0.011 0.192 0.40

small mink 0.5 0.079 0.293 0.048 0.154 0.52

large mink 1.8 0.062 0.229 0.168 0.120 0.52

small river otter 5.0 0.052 0.191 0.421 0.100 0.52

large river otter 15.0 0.042 0.157 1.133 0.087 0.55

Avian sandpipers 0.0 0.228 1.034 0.004 0.4119 0.40

cranes 6.7 0.030 0.136 0.211 0.0543 0.40

rails 0.1 0.147 0.577 0.010 0.2671 0.46

herons 2.9 0.040 0.157 0.120 0.0731 0.46

small osprey 1.3 0.054 0.199 0.069 0.1048 0.52

white pelican 7.5 0.029 0.107 0.228 0.0589 0.55

### 154 Table 15. Calculation of toxicity values for mammals and birds consuming fish contaminated by Oxathiapiprolin.

Wildlife Species Toxicity Values Acute Chronic
Dose Based (mg/kg

bw) Dietary Based (mg/kg

- diet) Dose Based (mg/kg

- bw) Dietary Based (mg/kg

- diet)

Mammalian fog/water shrew 10499.51 N/A 1049.95 10000

rice rat/star

nosed mole 7122.50 N/A 712.25 10000

small mink 4695.52 N/A 469.55 10000

large mink 3320.24 N/A 332.02 10000

small river otter 2571.84 N/A 257.18 10000

large river otter 1954.18 N/A 195.42 10000

Avian sandpipers 1168.26 5640.00 N/A 920

cranes 2794.44 5640.00 N/A 920

rails 1409.77 5640.00 N/A 920

herons 2464.58 5640.00 N/A 920

small osprey 2172.30 5640.00 N/A 920

white pelican 2842.12 5640.00 N/A 920

### 155 Table 16. Calculation of RQ values for mammals and birds consuming fish contaminated by Oxathiapiprolin.

Wildlife Species Acute Chronic Dose Based Dietary Based Dose Based Dietary Based

Mammalian fog/water shrew 0.000 N/A 0.000 0.000

rice rat/star

nosed mole 0.000 N/A 0.000 0.000

small mink 0.000 N/A 0.000 0.000

large mink 0.000 N/A 0.000 0.000

small river otter 0.000 N/A 0.000 0.000

large river otter 0.000 N/A 0.000 0.000

Avian sandpipers 0.000 0.000 N/A 0.000

cranes 0.000 0.000 N/A 0.000

rails 0.000 0.000 N/A 0.001

herons 0.000 0.000 N/A 0.001

small osprey 0.000 0.000 N/A 0.001

white pelican 0.000 0.000 N/A 0.001