UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON D.C., 20460 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

PC Code: 128111 

DP Barcodes: 41 7272; 417273; 417274; 417412 and 417416 

Date: July 1, 2015 

MEMORANDUM 

SUBJECT: Environmental Fate and Ecological Risk Assessment for the New Chemical 

Registration of Oxathiapiprolin for Proposed Uses on Brassica. Leafy, Bulb, 

Cucurbit, Fruiting, and Tuberous/Corm Vegetables; Ginseng; Peas; Tobacco; 

Ornamentals; and Turf 

TO: Marcel Howard, Risk Manager Reviewer 

Tony Kish. Risk Manager, RM 22 

FROM: 

Fungicide Branch, Registration Division (7505 P) ~MJU~::;·~O;::~=c~ ~~::: Ot/oJ j /5 

Mohammed A. Ruhman, Ph.D., Senior Agronomi~tpL<jl F CJ 7 / o ( I/ 5'" 

THRU: 

Justin Housenger. Biologist . 

Environmental Risk Branch 5 

Environmental Fate and Effects Division (7507 P) 

Mah Shamim, Ph. D., Chief, 

Environmental Risk Branch 5 

Environmental Fate and Effects Division (7507 P) 

Please find attached the subject 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 Oxathiapiprolin for Proposed Uses on 

Brassica, Leafy, Bulb, Cucurbit, Fruiting, and Tuberous/Corm 

Vegetables; Ginseng; Peas; Tobacco; Ornamentals; and Turf

Chemical Formula: C24H22F5N5O2S

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

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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 Laboratory 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 Hydrolysis, Aqueous photolysis and Photolysis on soil for the TPs/DEGs................................................42

3.3.3 Aerobic Soil Metabolism; 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 Exposure ..............................................................................................................................................48

(1) Aerobic Soil System (90th 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 Aquatic Food Items (KABAM)................................67

IV. Ecological Effects Characterization.................................................................................................................69

4.1. Aquatic Effects ....................................................................................................................................69

4.2. Terrestrial 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. Taxonomic Groups Potentially at Risk ..............................................................................................106

VI. Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps......................................109

VII. REFERENCES ..............................................................................................................................................114

Appendices

Appendix A. Transformation Products (TP) and Degradates (DEGs) Observed in Environmental Fate Studies ....127

Appendix B. Output of STIR Results.......................................................................................................................143

Appendix 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 products/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 exposure and effect for assessing the environmental risk of the proposed uses of 

oxathiapiprolin.............................................................................................................................................................20

Table 3.1. Labelled use patterns proposed for oxathiapiprolin....................................................................................23

Table 3.2 Oxathiapiprolin identity and structure .........................................................................................................24

Table 3.3 Physical and chemical properties of oxathiapiprolin ...................................................................................25

Table 3.4. Fate 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 (Kow)........................................................................................................................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 (Koc) 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 oxathiapiprolin.................................................................................................................................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. Summary of modeled foliar application parameters for oxathiapiprolin (refer to abbreviations, below).59

Table 3.23. Summary of modeled soil application parameters for oxathiapiprolin (refer to abbreviations, below; All 

7-d intervals between applications). ............................................................................................................................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. Screening-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 oxathiapiprolin1 ........................................70

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

Table 4.3. Summary of acute toxicity data to freshwater invertebrates exposed 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 oxathiapiprolin1 ..............................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 fish resulting from the highest peak EECs 

from the proposed uses of oxathiapiprolin ..................................................................................................................89

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 ...........................................................................................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 Oxathiapiprolin1 (Note: As 

a definitive acute dietary LC50 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 

Oxathiapiprolin1

...........................................................................................................................................................95

Table 5.10. Acute Dose-based RQ values for Birds and Mammals Exposed to Oxathiapiprolin1,2,3 (Note: As a 

definitive acute oral LD50 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 resulting from the 

highest peak EECs from the proposed uses of oxathiapiprolin .................................................................................101

Table 5.15. Summary of the acute and chronic risk profile for oxathiapiprolin for birds and mammals .................102
6

I. EXECUTIVE SUMMARY

This ecological risk assessment addresses the new systemic fungicide active ingredient 

oxathiapiprolin.

Oxathiapiprolin is proposed to be used as a foliar 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 tobacco. The product is 

delivered into the foliage or soil by conventional ground, aerial and air blast equipment, with the 

exception of application through transplant water, drench and chemigation. The proposed 

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 retreatments (12 

drench treatments in ornamentals) at a range of minimum intervals between 3 to 14 days. It is 

important to note that 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 sediment systems. In these systems, bio-transformation/biodegradation 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 higher 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 discrepancy 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 the chronic LOC for spiked sediment based RQs.

Estuarine Sediment-dwelling Invertebrates. No data are available for estuarine/marine 

sediment-dwelling invertebrates. Risk conclusions are similar to those for freshwater sedimentdwelling invertebrates (possible chronic risk). 

Aquatic Plants There 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 oxathiapiprolin 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. No acute dose-based or chronic dose and dietary-based RQs exceeded 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 use of 

oxathiapiprolin. The highest rates tested on plants, which was more than twice the highest 

proposed application rate, did not elicit a toxicity endpoint at the 25% level. The no-adverse effect 

concentration (NOAEC) also exceeded the maximum application 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 acute risk estimation to 

adult honey bees via direct contact and oral exposure resulting from foliar and soil applications 

indicate all RQs fall below 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 represent 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-field 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 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 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 level 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 invertebrates. 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 level 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. Therefore, 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 oxathiapiprolintreated 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. PROBLEM FORMULATION

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 Ecological 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 required 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 under 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 

guidance 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 residual and anti-sporal 

effects. Oxathiapiprolin is locally systemic, translaminar chemical that moves systemically in the 

xylem. As will be discussed in details later, the fungicide is proposed to be widely used in the US 

to control/suppress Oomycete diseases throughout 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, oxathiapiprolin is the first in 

a novel chemical group of fungicides known as the piperidinyl thiazole isoxazolines. 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 152 with a proposed target site as oxysterol binding protein (OSBP) inhibition. Use of 

this chemical is assumed to require resistance risk management because it is a single site inhibitor

and resistance risk is assumed to be medium to high. The registrant suggested that the target 

protein was determined to be the oxysterol-binding 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 mutations 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 fungal 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 registrants 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 mycelial 

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

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 sediment systems. In these soil and water sediment systems, bio-transformation/biodegradation are the major processes that are expected to affect the fate of oxathiapiprolin. Detailed 

physical/chemical fate and transport properties for oxathiapiprolin and its transformation products 

and degradates (hereafter referred to as TPs and DEGs, respectively) are included in Section 3 of 

this assessment.

2.2.4. Stressor Source, Identity, and Intensity

The source of the stressor is application of the fungicide oxathiapiprolin to foliage or soil and the 

fate and transport of parent and resultant TPs/DEGs in important compartments of the 

environment. In contrast, identity and intensity are based on characterizing exposure and toxicity 

of the residues in these environmental 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 aquatic 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, amphibians, 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 invertebrates (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 generated 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 pesticide 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 effects 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.

1Table 2.1. Taxonomic groups and example test species for potential effects of oxathiapiprolin.

Tax

ono

mic 

Gro

up

Exa

mple

(s) of 

Surr

ogat

e 

Spec

ies

Acute Toxicity Classification

Bir

ds1

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

ts3

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 

flosaqua

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 

(Peu

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, of 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 impounded 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, and 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 ecological 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 description 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 hypothesis and a conceptual diagram (USEPA 1998).

2.6.1. Diagram

Based on the preliminary iterative process of examining fate and effects data, the conceptual model 

for spray application to agricultural crops (foliage and soil) has been established, refined and 

included in Figures 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

* For Riparian plants terrestrial exposure refer to Figure 2.2, below

1Figure 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 primary exposure routes for aquatic organisms include spray 

drift and runoff 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 that the primary exposure routes for terrestrial organisms include 

direct contact with spray droplets, dermal contact with 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 also 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 primary 

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 processed 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

Individual 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

2Figure 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 this ecological risk assessment:

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

foliar and soil applications 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 commonly 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 (LD50), medial lethal concentration to 50% of 

tested organisms (LC50), the no observed 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 Measures of Aquatic Exposure

Screening-level EECs of oxathiapiprolin 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 model 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. The 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 Water 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 website3.

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 models4 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 this assessment.

Terrestrial wildlife are exposed to oxathiapiprolin via consumption of residues on food items 

generated by spray applications. For spray applications, the T-REX model (Terrestrial Residue 

EXposure model; v. 1.5.2; June 6, 20135) 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 dissipation 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 and 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 terrestrial 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 site6

The Screening Tool for Inhalation Risk (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 results 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 LD50 = >5000 mg/kg bw, MRID 49011165; and 

rat inhalation LC50 5.1 mg/L, MRID 49011167, respectively) as well as the most sensitive acute 

oral avian toxicity endpoint (bobwhite quail LD50 >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 determined 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 website7.

 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 Screening Imbibition Program (SIP v.1.0, released 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 

LD50 of >2250 mg a.i/kg-bw and chronic NOAEC of 920 mg a.i/kg-diet; rat acute oral LD50 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 concern 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 website8.

Finally, bioaccumulation will be assessed using the results from bioaccumulation in fish studies, 

as well as the KABAM model (KOW (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 

consuming aquatic organisms which have bioaccumulated these pesticides. More information 

about this model can be found at the EPA website9.

2.7.4. Measures of Effect

Measures of ecological effects are obtained from a suite of registrant-submitted guideline studies 

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 based 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 considered, 

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., LD50, LC50) 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 mortality, 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

2Table 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 birds1

2. Abundance (i.e. survival, 

reproduction, and growth) of 

individuals and populations 

of mammals.

3. Survival and reproduction 

of individuals and 

communities of freshwater 

fish2 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 individuals 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 EEC3

Estimates of runoff and 

spray drift to non-target 

areas

Peak surface water EEC

1a. Zebra finch and northern bobwhite quail acute 

oral LD50

1b. Mallard duck and northern bobwhite quail subacute dietary LC50

1c. Mallard duck and northern bobwhite quail

chronic reproduction NOAEC and LOAEC

2a. Laboratory rat acute oral LD50

2b. Laboratory rat multi-generation reproduction 

chronic NOAEL and LOAEL

3a. Rainbow trout and bluegill sunfish acute LC50

3b. Rainbow trout early life stage NOAEC

3c. Daphnid acute EC50

3d. Daphnid chronic reproduction NOAEC and 

LOAEC

4a. Sheepshead minnow acute LC50

4b. Sheepshead minnow chronic early life stage 

NOAEC and LOAEC

4c. Saltwater mysid acute LC50, estuarine/marine 

mollusk EC50 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 EC25 values 

7a. Lemna gibba EC50 values based on yield and 

growth rate

7b. Algal EC50 values based on cell density, 

growth rate, and biomass

LD50 = Lethal dose to 50% of the test population; NOAEC = no-observed adverse effect concentration; LOAEC = 

lowest-observed adverse effect concentration; LC50 = lethal concentration to 50% of the test population; EC50/25 = 

effect concentration to 50/25% of the test population.

1

According to EFED risk assessment guidance, birds may be used as surrogates for terrestrial phase amphibians and 

reptiles

2

According to EFED risk assessment guidance, freshwater fish may be used as surrogates to aquatic phase 

amphibians

3

Based on a 1-in-10 year return frequency 
24

III. EXPOSURE ASSESSMENT

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 plants 

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 minutes 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. There are no 

residential uses 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); cauliflower; 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; lady’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 leaves; 

• 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, balsam 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 varieties 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 

eggplant; 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; dandelion; 

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 the 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: The product is applied in a 4 to 12”inch band. 

For each field (i.e., acre rate), the equivalent rate is provided in a Table based on the crop 

row spacing (The table provides the rate in fl. Oz. product/1000 row of crop feet in inches). 

This type of application 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: ground (using ground field sprayers); aerial (using aircraft); or air 
26

blast (using air assisted field ground sprayers).

3.1.5 Application Parameters for the Labelled Use Patterns

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

important application parameters.

3Table 3.1. Labelled use patterns proposed for oxathiapiprolin

Crop Use Pattern (Product)

Application Parameters 1

MSR MNA Notes 2 MTR MAI 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 

vegetables

0.0311 2 0.0622

5

In season when disease develops. Assume using another 

fungicide before the 3rd 0.0260 1 0.0260 (7-day)

0.0441 2 0.0882 10 At nickel-sized tubers (flowering) 

Total 5 0.1764 Ground Airblast and Aerial

Soil Application for the OD formulation (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 3rd (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 3rd (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 1st cultivation and layby in furrow; 

***Assume using another fungicide before the 3rd (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/indoor plants

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

0.2503 2 0.5006 7

Ground application 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

MSR MNA Notes 2 MTR MAI 3

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

action”; 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 3rd and 4th interval. For example: the applications for 

Brassica will be as follows: 1st application of 0.0311 lb. a.i/A (assume April, 1), 2nd application of 0.0311 lb. a.i/A after 5 days 

(April, 6), No application for the 3rd interval of 5 days; 3rd 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 crops

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 shows significant fungicidal activity with INQ7N24 and IN-Q7N25, indicating 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 transport 

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 enantiomers.

4Table 3.2 Oxathiapiprolin identity and structure

Common Names 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 C24H22F5N5O2S

N O

S

N N

O

N

N

CH3

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.

5Table 3.3 Physical and chemical properties of oxathiapiprolin

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 m3 mole-1

Log Kow @ 20 ̊C & pH 7

Kow @ 20 ̊C & pH 7

3.60

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 application 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 m3 mole-1

, respectively at 20°C). The 

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; and photolysis on soil.

6Table 3.4. Fate 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 halflives @ 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 Degradates1: 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 @ 

20 °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 TPs 3 & Degradates: None

Minor TPs & 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 Cleavage 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 compounds 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 TPs= 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 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 were estimated at 82 days on moist soil. Photolysis in aqueous media did not 

cause mineralization of oxathiapiprolin to CO2 (CO2 <LOQ) but it produced the major 

transformation product IN-P3X26 (maximum formation of 14%) and the minor degradates INRLD51 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 were observed reaching a total maximum of 39%.

Photolysis on soil did not cause mineralization of oxathiapiprolin to CO2 (CO2 <LOQ) and did not 

produce major transformation products/degradates. The process produced two minor 

transformation products: IN-RDT31 and IN-RAB06 and four minor degradates: IN-E8S72, INRLD51, 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 INRAB06 and degradates IN-RLD51 and IN-RSA90 declined after reaching maximum formation 

rates of 3-5%. The degradate IN-WR791 was detected at low levels but was not quantified. Many 

unidentified degradates reached a maximum formation rate of 9% and un-extracted soil residues 

reached a maximum of 8%.

Based on these results, photolysis in aqueous media and on soil are not expected to be major 

contributors to dissipation of oxathiapiprolin in the natural environment. It is noted that, with the 

exception of the degradate IN-RSA90, photolysis on soil produces the same transformation

products (IN-RAB06 and IN-RDT31)/degradates (IN-E8S72 and IN-WR791) which form in 

aerobic soils. The degradate 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 photolysis DEG INRSA90, 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 μg a.i./g soil are available for oxathiapiprolin. Table 3.5 contains a 

summary of properties of the soil systems used in these studies and associated radiolabeled 

positions.

7Table 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-

14C 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-

14C 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-

14C

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.

8Table 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

CH3

F

F

F

F

F

Study Description or Value & Other Relevant Information (Abbreviations 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 & DEGs (% of the applied parent)

Chemical Range When? EOS Detected <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 TPs & DEGs (% 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, not 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: TPs= 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 cleavage of the backbone structure

Range= Range of observed maximums; When?= Days when maximums occurred; EOS= End of study concentration; 

Detected= Number of systems with detection; <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..
32

Aerobic soil data in Table 3.6 indicate that oxathiapiprolin is a relatively persistent compound 

(90th 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 CO2 (<LOQ to 12%) which appears to be mainly 

associated with cleavage of 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 (Maximum formation of 14%), IN-RDT31 

(Maximum formation of 9%), and IN-Q7D41 (Maximum 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 pyrazole 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 between certain rings of the 

structure of the parent, transformation products and/or degradates. These degradates are INQPS10 (Maximum formation of 9%), IN-E8S72 (Maximum formation of 7%), IN-RLD51 

(Maximum formation of 4%) and IN-WR791 (detected but not quantified). The degradate INQPS10 appears to decline while no apparent decline was observed for IN-E8S72 and INRLD51; and

(4) Transformation into un-identified degradates ranging from 6 to 30% and un-identified unextracted 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 data suggest:

(1) Parent labelled at the three rings confirms production of the transformation products: INRAB06, 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-WR791 was also a result of cleavage of IN-RDT31, between the pyrazole and 

piperidine rings. This was confirmed by an aerobic soil study with pyrazole-5-

14C 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-

14C 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-

14C IN-RAB06 as a test substance; and 
33

(4) Mineralization with variable production of CO2 (<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: H2O (90:10); (2) Acetonitrile: H2O (90:10); (3) Acetonitrile: 0.1 M NH4 

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 provide 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 initiating 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 significant 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 14C 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 

summarized in Table 3.7. 

9Table 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 (Abbreviations 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 TPs & DEGs (% of the applied parent)

Chemical Start Range When? EOS Detected <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

CO2: No new production after the aerobic phase

Un-extracted Residues (UER): Max= 6-7% @ EOS

MRID

490112-52

1 Abbreviations: Near Major TPs & Degradates: TPs= 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 cleavage of the backbone structure

Start= Concentration at the start of the anaerobic phase (only for aerobic/anaerobic study); Range= Range of observed 

maximums; When?= Days when maximums occurred; EOS= End of study concentration; Detected= Number of 

systems with detection; <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 INRAB06 TP and N-QPS10 DEG declined to non-detection (Table 3.7). However, TP IN-RDT31 

and DEG IN-E8S72 showed no decline. In contrast, data suggest that very little transformation 

occurred during the 120 anaerobic phase with no new mineralization occurring to CO2. This was 

reflected in the estimated 1,505 day half-life of the chemical 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 affected 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 aerobic and anaerobic metabolism of oxathiapiprolin was studied in two water/sediment 

systems with oxathiapiprolin radiolabeled at three positions: Pyrazole-5 14C, Thiazole-5 14C and 
35

Isoxazoline-5 14C. 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. 

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

aerobic/anaerobic water/sediment studies

System

System Name and 

Location1

Label Location in 

the Chemical 

Structure

Water Sediment

pH MRID

DOC 

(mg/L) Texture pH OC

CEC

(meq/100 g)

AEROBIC

Swiss

Lake

Pyrazole-5 14C 

Thiazole-5-

14C 5.8 28.4 LS 5.3 0.7% 4

490112-79

Calwich Abbey 

Lake

Pyrazole-5 14C 

Thiazole-5-

14C 6.7 25.9 SiL 7.1 4.9% 24

ANAEROBIC

Swiss

Lake

Pyrazole-5 14C 

Thiazole-5-

14C 7.0 12.1 LS 5.1 0.6% 7

490112-80

Calwich Abbey 

Lake

Pyrazole-5 14C 

Thiazole-5-

14C 7.5 5.6 SiL 7.1 5.0% 31

Swiss

Lake

Pyrazole-5 14C

Isoxazoline-5-

14C 6.5 7.3 LS 5.1 0.8% 3

490112-81

Calwich Abbey 

Lake

Pyrazole-5 14C

Isoxazoline-5-

14C 7.8 2.5 SiL 7.2 5.2% 15

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

Tables 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.

11Table 3.7 Summary of the fate properties of oxathiapiprolin in the aerobic water/sediment 

systems
36

Study Description or Value & Other Relevant Information (Abbreviations 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 Calwich Abbey Lake, UK

Near Major TPs & DEGs (% 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 & DEGs: None

Other degradation Products: Unidentified Degradates: Max= 15-40% @ EOS

CO2: Max= 0.2- 7% @ study termination

Un-extracted Residues (UER): Max= 7-17% @ study termination

MRIDs

490112-79

* Abbreviations: Near Major TPs & Degradates: TPs= 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 cleavage of the backbone structure; Range= Range of 

observed maximums; When?= Days when maximums occurred; EOS= End of study concentration; Detected= 

Number of systems with detection; <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

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

systems

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

Anaerobic 

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 TPs & DEGs (% 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: TPs= 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 cleavage of the backbone structure; Range= Range of 

observed maximums; When?= Days when maximums occurred; EOS= End of study concentration; Detected= 

Number of systems with detection; <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.

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 90th percentile t 1⁄2 = 143 days “n=2”) compared to anaerobic 

aquatic systems (Range t 1⁄2 = 45-158 days and 90th 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 90th percentile t 1⁄2 of 161 days. Based on the 90th percentile 
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 90th

percentile half-lives estimated for the aerobic aquatic 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 transformed into five transformation products:

i. Two showing no decline: IN-Q7D41 and IN-S2K66 with maximum formation of 12 

to 9%, respectively. 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 INRAB06 was produced from parent by hydroxylation of the methyl group of the 

pyrazole ring in the parent structure;

b. No degradates were identified;

c. Mineralization into CO2 with maximums ranging from 0.4% (from the Pyrazole-5 14C 

labels) to 7% (from Thiazole-5 14C labels); and

d. Transformation into un-identified degradates ranging from 15 to 40% and un-identified 

un-extracted residues ranging from 7 to 17%.

In 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%, respectively 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 structure; 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%, respectively. 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 CO2 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%

OH

O N

O

N

N

CH3

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

CH3

S

N N

O

N

N

CH3

F

F

F

IN-S2K67

An-Aerob Aq= 14%

OH

CH3

S

N N

O

N

N

CH3

F

F

F

2,6DFBA/IN-YY147

An-Aerob Aq= 18%

HO

O

F

F

IN-RDT31

Aerob Soil= 9%

Oxathiapiprolin Parent

1

1

2

3 2

4

3

5

6

IN-RBR89

An-Aerob Aq

2%

O

IN-RSE01

Aerob Aq= 10%

An-Aerob Aq= 17%

O OH

IN-Q7D41

Aerob Soil 3%

Aerob Aq= 12%

 
40

3Figure 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 application 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.

13Table 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 490112-66

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 490112-64

Okanagan Falls, 

British Columbia, 

Canada

0.35 

+ 

0.34 Two

12-08 

And

26-08 

(F-veg) SL 6.7 1.3 9 490112-65

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 day-month (Crop related to this timing: F-veg= Fruiting 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 matter/ 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.

14Table 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

TFD

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= 212 days (SFO) in Cambridgeshire, UK

t 1⁄2= 104 days (DFOP) in Seville, Spain

MRIDs

490112-

50/51/55

Near Major TPs & DEGs (% 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: IN-E8S72 3.5-11.5% 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 IN-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 Cleavage 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 Detection/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 90th –

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 transformation 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 90th 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 90th percentile t 1⁄2 was calculated to 

equal 127 days; calculated from dissipation half-lives for 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 days 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-RAB06 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 ranging, 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 soils. 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 (Maximum 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; 2000) (Average Kfoc= 12,800 mL/g “n=6”), 

INRDT31 and IN-QPS10 are slightly mobile (Average Kfoc= 1,168 and 4,880 mL/g “n=5”, 

respectively), IN-RAB06 is moderately mobile (Average Kfoc= 496 mL/g) and IN-E8S72 is 

highly mobile (Average Kfoc= = 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. The 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 more than the LOQ of 1.0 μg/Kg for soil (sediment).

3.2.7 Environmental Mobility of Parent

Adsorption data for oxathiapiprolin indicate that the chemical is hardly mobile Kfoc 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). 

15Table 3.10. Adsorption coefficients for oxathiapiprolin in six soils along with the main 

characteristics of the soils (MRIDs 49011270 and 49011271).

Soil Texture OC (%)

pH (0.01 M 

CaCl2 1:2)

CEC 

meq/100g

Kfoc

(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 12,810

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 if the chemical reaches the anaerobic 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 soils, 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 confirms 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 weights 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

17Table 3.11. Transformation products (TPs) and degradates (DEGs) of oxathiapiprolin: water 

solubility in ppm @ 20 oC and octanol/water coefficient (Kow)

Chemical Solubility Log KOW KOW Chemical Structure

Transformation Products (TPs)

IN-RDT31 1.04 2.95 891

IN-RAB06 32 -0.05 1

IN-RYJ52 Isomers:

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 OH

S

N N

O

N

N

CH3

F

F

F

F

F
45

Chemical Solubility Log KOW KOW 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

* EPISUITE 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 Hydrolysis, 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 formation/decline of some of the TPs/DEGs were not observed. However, supplemental 

studies were submitted in which the test substances were selected TPs or DEGs. The latter studies 

are of added value as they confirm segment(s) of the proposed degradation pathway 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 qualitative 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

CH3

S

N N

O

N

N

CH3

F

F

F

OH

CH3

S

N N

O

N

N

CH3

F

F

F
46

18Table 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)

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.: Aerobic 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 contains a summary of the fate properties of oxathiapiprolin transformation product

IN-RAB06 in aerobic soil systems. 

19Table 3-13 Summary of the fate properties of IN-RAB06, a transformation product of 

oxathiapiprolin in soil systems (120 day study @ 20°C)

IN-RAB06: 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 days (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% @ study 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 ranged from 23 to 215 with a 90th percentile 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 the 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 (Maximum formation of 2% of the 

applied with no apparent decline) when the compound was labeled at the thiazole ring. 

Mineralization to CO2 was the major degradation processes for this transformation product

(evolved CO2 ranged from 11 to 47%)

Table 3.14 contains a summary of the fate properties of oxathiapiprolin transformation product

IN-RDT31 in aerobic soil systems. 
48

20Table 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

CO2: = 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 suggest 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 

(reached a maximum formation of 5% of the applied then declined). 

Table 3.15 contains summaries of the fate properties of oxathiapiprolin degradates IN-E8S72

(labelled at the pyrazole ring) and IN-QPS10 (labelled at the thiazole ring), respectively. For INE8S72 degradate, five soil systems were used and four were used for IN-QPS10 degradate.

21Table 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= >1,000 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

CO2: = 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

CO2: 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 suggest that the degradate IN-E8S72 is a highly persistent compound (t 1⁄2 

ranged from 271 to >1,000 days). Limited mineralization to CO2 occurred (maximum evolved 

CO2 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 two 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 INRDT31 (MRIDs 490112-76 and 490112-73, respectively) and two degradates IN-E8S72 and INQPS10 (MRIDs 490112-75 and 490112-74). This data is summarized in Table 3.16. 
50

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

Soil Texture OC (%)

pH (0.01 M 

CaCl2 1:2)

CEC 

meq/100g

Kfoc

(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 7.4 837

Tama, USA Silty clay loam 1.9 19 5.7 2,517

Lleida, Spain Clay 2.0 17 7.5 628

Gross-Umstadt, Germany Loam 1.2 11 6.7 1,177

Sassafras #16, USA Sandy loam 3.1 8 5.1 682

Average (n= 5) 1,168

IN-E8S72 Degradate

Tama, USA Silty 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 Silty 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, desorption 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, desorption 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, desorption 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, desorption 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

23Table 3.17 Mean adsorption coefficients (Koc) for selected TPs and DEGs as determined by 

the HPLC method

TP or DEG Level and Systems Where it Was Observed Mean Koc 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, oxathiapiprolin 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 degradates (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 extensive 

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 toxicities.

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 target plants and later affected 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 expected 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 foliage 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 “rainfast” property of the chemical is expected 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 left 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 influential 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 application or washoff, 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/DEGs 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 transport data presented earlier in this document. 
53

4Figure 3.2 Processes and levels of transformation products/degradates of oxathiapiprolin in soil 

and aquatic systems

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

 

 Slow Aerobic Soil Transformation/Degradation Processes

 (2) Water/Sediment Systems (90th -ntile t 1⁄2 = 143/121 days for Aerobic/anaerobic) 

 

 Slow Aerobic/Anaerobic Aquatic Transformation/Degradation Processes

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

apparent decline and Bold Italic= Showed decline.

In 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 residues 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 residues 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 (Koc). Relatively 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 (Koc= 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, INS2K66, 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: INE8S72 and IN-QPS10. 

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, and 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 degradates. 

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 was 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 toxicity 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-QPS10, 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 rapid operculum movement in 5 of 7 fish at this 

concentration. All studies are classified as acceptable.

24Table 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)

LC50 (95% CI; 

slope)1

Acute Toxicity 

Classification2

Study 

Classification 

(MRID)

Parent 

oxathiapiprolin Static TGAI (95.8%)

96-hr LC50: >0.69 

mg/L (N/A; N/A) Highly toxic Acceptable(49011289)

IN-RYJ52 Static TGAI (67%) 96-hr LC50: > 13.8 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011292)

IN-S2K66 Static TGAI 

(88.7%)

96-hr LC50: >7.48 

mg/L (N/A; N/A) Moderately toxic Acceptable (49011293)
56

Degradation / 

Transformation 

Product

Exposure 

System

Test 

Substance 

(Purity)

LC50 (95% CI; 

slope)1

Acute Toxicity 

Classification2

Study 

Classification 

(MRID)

IN-Q7D41 Static-renewal TGAI 

(90.3%)

96-hr LC50: >0.18 

mg/L (N/A; N/A) Highly toxic Acceptable(49011294)

IN-RSE01 Static-renewal TGAI 

(83.2%)

96-hr LC50: >9.84 

mg/L (N/A; N/A) Moderately toxic Acceptable(49011295)

IN-P3X26 Static TGAI 

(93.8%)

96-hr LC50: >67.7 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011296)

IN-S2K67 Static TGAI 

(92.7%)

96-hr LC50: >82.5 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011297)

IN-QFD61 Static TGAI 

(92.7%)

96-hr LC50: >7.38 

mg/L (N/A; N/A) Moderately toxic Acceptable(49011298)

IN-RAB06 Static TGAI 

(97.0%)

96-hr LC50: >49.7 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011298)

IN-QPS10 Static TGAI 

(94.8%)

96-hr LC50: 6.54 

mg/L (5.59 – 7.65; 

N/A)

Slightly toxic Acceptable

(49011301)

IN-E8S72 Static TGAI 

(99.1%)

96-hr LC50: >102

mg/L (N/A; N/A)

Practically nontoxicAcceptable

(49011302)

IN-RDT31 Static TGAI 

(93.6%)

96-hr LC50: >11.6 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011303)

LC50 = 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

Although the acute toxicity 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 LC50).

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 concentration 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 negative and solvent controls). The percent mortality for each of the 7 concentrations was 0, 

10, 10, 15, 20, 30, and 60%, respectively. For IN-QPS10, there were 5 mean measured 

concentrations ranging from 2.27 – 36.3 mg a.i/L (as well as negative and solvent 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

25Table 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)

LC50 (95% CI; 

slope)1

Acute 

Toxicity 

Classification2

Study 

Classification 

(MRID)

Parent oxathiapiprolin Static TGAI 

(95.8%)

48-hr EC50: >0.56 

mg/L (N/A; N/A) Highly toxic Acceptable(49011347)

IN-RAB06 Static TGAI 

(97.0%)

48-hr EC50: >95.3 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011317)

IN-RDT31 Static TGAI 

(93.6%)

48-hr EC50: >10.5 

mg/L (N/A; N/A) Slightly toxic Acceptable (49011318)

IN-QPS10 Static TGAI 

(94.8%)

48-hr EC50: 14.7 mg/L 

(12.2 – 17.8; 5.57) Slightly toxic Acceptable(49011319)

IN-E8S72 Static TGAI 

(99.1%)

48-hr EC50: >100 

mg/L (N/A; N/A)

Practically 

non-toxic

Acceptable

(49011320)

IN-RYJ52 Static TGAI (67%) 48-hr EC50: > 16.2 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011321)

IN-S2K66 Static TGAI 

(88.7%)

48-hr EC50: 0.42 mg/L 

(N/A; N/A) Highly toxic Acceptable(49011322)

IN-Q7D41 Staticrenewal

TGAI 

(90.3%)

48-hr EC50: >0.15 

mg/L (N/A; N/A) Highly toxic Acceptable(49011323)

IN-RSE01 Static TGAI 

(83.2%)

48-hr EC50: >10.2 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011324)

IN-P3X26 Static TGAI 

(93.8%)

48-hr EC50: >67.7 

mg/L (N/A; N/A) Slightly toxic Acceptable(49011325)

IN-S2K67 Static TGAI 

(92.7%)

48-hr EC50: 59.2 mg/L 

(32.3 - 177; 1.11) Slightly toxic Acceptable(49011326)

IN-QFD61 Static TGAI 

(92.7%)

48-hr EC50: 5.14 mg/L 

(3.74 – 8.48; 2.49)

Moderately 

toxic

Acceptable

(49011327)

EC50 = 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 toxicity 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 EC50).

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, INRAB06, 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 negative 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 concentration. The EC50, 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 solvent 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 EC50, 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 negative 

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 this scenario, is to use the EC05 for risk 

estimation to listed species. The EC50, EC05, 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 concentrations 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 under the 

curve determined at all treatment concentration and therefore a definitive NOAEC was not 

achieved. The EC50, EC05, 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 concentrations 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 from 11-29%) (p<0.05) for all endpoints assessed at all treatment 

concentrations and therefore a definitive NOAEC was not achieved. The EC50, EC05, and LOAEC 

were determined to be >7.56, 3.53, and 4.27 mg a.i/L, respectively. Finally, in a study with INS2K67, 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 EC50, EC05, and LOAEC were determined to be >83.5, 0.008, and 0.28 mg a.i/L, respectively. 

All studies were classified as acceptable.

26Table 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 EC50: >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 EC50: >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 EC50: 9.21 mg/L (8.29 –

10.2)

72-hr EC05: 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 EC50: >83.5 mg/L (N/A, 

N/A)

72-hr EC05: 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 EC50: >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 EC50: >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 EC50: >11.4 mg/L (N/A, 

N/A)

72-hr EC05: 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 EC50: 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 EC50: >102 mg/L (N/A, 

N/A)

72-hr NOAEC: 102 mg/L

72-hr LOAEC: >102 mg/L

None Acceptable

(49011343)

IN-Q7D41 Staticrenewal TGAI (90.3%)

72-hr EC50: >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 EC50: >10.1 mg/L (N/A, 

N/A)

72-hr EC05: 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 EC50: >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

EC50 = 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 EC05 for use in risk estimation to listed 

species of aquatic plants.

3.4.1.3 Rationale 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 these 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 the 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, this degradate was not examined in terrestrial field dissipation studies because it is a 

minor degradate in the laboratory aerobic soil study (maximum formation rate of 1-3%) and is not 

expected to form at a high rate in a field setting. Finally, this degradate 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 the study with INQ7D41 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 to certain degradates). The degradate INS2K66 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 considered 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 

measured 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 ecotoxicological 

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 

invertebrates, 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 ecotoxicological 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 ecotoxicological 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 plants.

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 that the environmental fate data indicate the formation of another major degradate, 2, 6-

DFBA/IN-YY147 (Maximum formation rates of 10-18% with no decline in anaerobic aquatic 

study) with no ecotoxicity data available. Therefore, ECOSAR (v1.1) was used to estimate the 

toxicity using quantitative structure activity relationships (QSARs). ECOSAR predicts toxicity 

using a regression of the log KOW and measured toxicity endpoints for a particular species and 

chemical class. The sole ECOSAR class that returned results 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 available. Therefore, 2, 6-DFBA/IN-YY147 is not expected to be of ecotoxicological 

concern to aquatic taxa. 

27Table 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)

71501 37621 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. Suggested labeled application parameters/ 

representative scenarios are summarized in Table 3.22 for foliar application and Table 3.23

28Table 3.22. Summary 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 first 

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 

resistant 

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 

Others CARowCropRLF_V2 0.0311 2+2 0.1245 3

Peas Snap bean ORsnbeansSTD 0.0311 2+2 0.1245 5

Tuberous/

Corm 

vegetables

Potatoes

CAPotatoRLF_V2 

FLpotatoNMC 0.0311 2 0.0622 5

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 yearly application 

(Kg/ha/year); and the FAD(s)= First application date(s)

29Table 3.23. Summary 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:

1st near planting

2nd after 7-days

3rd after 14 days (7d x 2 for 

resistant management)

STXmelonNMC 

MImelonStd 

MOmelonStd 0.2503

NJmelonStd 

Cucumber FLcucumberSTD 0.2192

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 1st application near planting

FLnurserySTD_V2 

MInurserySTD_V2 

NJnurserySTD_V2 

ORnurserySTD_V2 

TNnurserySTD_V2 

Ornamentals

Nurseries 

Soil

CAnurserySTD_V2 

0.2503 2 0.5006

1st 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; MYR= Maximum yearly 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 

31Table 3.24.
64

30 31Table 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 (MRIDs 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

Photolysis reference latitude ( MRID 490111-22 o) 40

Hydrolysis half-life @ pH 7 (days) (0) Stable MRID 490111-21

Soil half-life (days) 1 161 @ 25 oC

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 Aerial 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.

32Table 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 

Vegetables

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 

Vegetables

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

Vegetables 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 

Vegetables

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 

Vegetables

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 

Vegetables

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 ZorvecTM EnicadeTM formulation, and foliar applications of OXATHIAPIPROLIN FHG (oil 

dispersion formulation) 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-REX, version 1.5.2.) is used to estimate 

exposures and risks to avian and mammalian species. 

For food crops, ZorvecTM EnicadeTM 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 lbs 

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 foliar 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 resultant RQs that exceeded 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 ground 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 3.26). 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. 

33Table 3.26. Input parameters for deriving screening-level terrestrial EECs for the proposed

uses of oxathiapiprolin.

Uses Represented

Single App 

Rate

(lb a.i./A)

Max No. of Apps 

at Max Rate

Min. Interval 

Between Apps (days)

Food crops – ZorvecTM EnicadeTM foliar spray uses

Ginseng 0.25 2 14

Food Crops – ZorvecTM EnicadeTM 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 uncertainties 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 foliar 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 directly on food 

items. Tables 3.27 and 3.28 provide the screening level dietary and dose-based EECs, respectively, 

for terrestrial animals.

As mentioned above some 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 applications. 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.

34Table 3.27. Screening-level dietary-based EECs (mg/kg diet) as food residues for birds and 

mammals for the proposed uses of oxathiapiprolin

Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short 

Grass

Tall 

Grass

Broadleaf 

Plants

Fruits, 

pods, 

seeds, etc.

Arthropo

ds

Use(s) 

Ginseng 105 48.3 59.3 6.59 41.3

Cucurbit, fruiting, and leafy vegetables 

and tobacco 120 55.0 67.5 7.50 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

35Table 3.28. Screening-level dose-based EECs (mg/kg-bw) as food residues for birds and mammals for the proposed uses of 

oxathiapiprolin

Primary Feeding 

Strategy  Herbivores and Omnivores Insectivores Granivores

Animal Size  Small Med Large Small Med Large Small Med Large

Dietary Items 

Short Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 28.12 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 EC25 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 lbs

a.i/A for seedling emergence and vegetative vigor tests, respectively (MRID 49011398 and 

49011399, respectively). These application rates approximately 2.2X the maximum single 

application rate of 0.25 lbs a.i/A). Furthermore, NOAEC values for terrestrial plants also exceeded 

the maximum single application rate of oxathiapiprolin 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 pesticide risks to honey bees10, 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 available. 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 3.29 below and the 

exposure estimates to be used in risk estimation are presented in Table 3.30.

36Table 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.

Measurement Endpoint Exposure Route Exposure Estimate1

Foliar applications

Individual 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 1Based no food consumption rates for adult worker bees and concentrations in pollen and nectar.

 10 Available online at: http://www2.epa.gov/sites/production/files/2014-

06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf
70

37Table 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 estimate2 Briggs EEC3

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

Derived from Briggs Model approach using oxathiapiprolin Log KOW of 3.6 and KOC 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 (KOW (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 aquatic 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 aquatic ecosystems (Arnot and Gobas, 2004). KABAM relies on a 

chemical's octanol-water partition coefficient (KOW) 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 reptiles) 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 an 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 

Appendix E 

By default, KABAM assumes zero for the metabolism rate constant (Km). For oxathiapiprolin, 

direct estimates of the metabolism rate constant (km) were not available. 
71

Four pesticide-specific inputs are required to estimate oxathiapiprolin residue concentrations in 

aquatic organism tissues: 1) log Kow, 2) Koc, 3) aqueous concentration of oxathiapiprolin, and 4) 

sediment pore water concentrations of oxathiapiprolin. The Koc and log Kow are based on 

registrant-submitted studies (see Tables 2.1 and 3.5). It is noted that the KABAM estimated time 

to steady 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 generating the highest peak EECs (PA vegetable) NMC

38Table 3.31. KABAM input values for oxathiapiprolin

Parameter Input Value Source

Pesticide Name Oxathiapiprolin --

Log KOW 3.6 Product Chemistry

KOC 12,810 49011270 and 49011271

Highest Exposure Scenario Modeled

Use patterns Fruiting vegetables (all) (PA vegetable NMC scenario)

(Label application instructions)

Pore 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. 

39Table 3.32. EECs for mammals and birds consuming fish contaminated by oxathiapiprolin

Wildlife species EECs

Dose Based (mg/kg-bw/d) Dietary based (ppm)

Mammalian

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. ECOLOGICAL EFFECTS CHARACTERIZATION

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 chronic 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 fish 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 mollusk, 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 aquatic-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) and the effects on 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 the 

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 LC50 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 LC50 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 during 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 normal on days 3 and 4. The 96-hour LC50

was determined to be >0.52 mg a.i/L and this study is classified as acceptable. 

40Table 4.1. Summary of acute toxicity data to freshwater fish exposed to oxathiapiprolin1

Species Exposure 

System

Test Substance 

(Purity)

LC50 (95% CI; 

slope)2

Acute 

Toxicity 

Classification3

Study 

Classification 

(MRID)

Rainbow trout 

(Oncorhynchus 

mykiss) Static

TGAI (95.8%) 96-hr LC50: >0.69 

mg/L (N/A; N/A)

Highly toxic

Acceptable

(49011289)

Formulation (Oil 

dispersion) (10.4%)

96-hr LC50: >0.51 

mg/L (N/A; N/A)

Acceptable 

(49050532)

Bluegill sunfish 

(Lepomis 

macrochirus)

TGAI (95.8%) 96-hr LC50: >0.72 

mg/L (N/A; N/A)

Acceptable

(49011290)

LC50 = 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 endpoint, 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; slope) if 

available

3

Although the acute toxicity classification is “highly toxic,” these studies did not elicit a 50% mortality response 

up to the limit of solubility. The designation is based on the standard EPA classification system.

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), mean-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 to 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 

classified as acceptable. 

41Table 4.2. Summary of chronic toxicity data to freshwater fish exposed to oxathiapiprolin

Species

Test 

Substance

(Purity)

Exposure 

system Endpoint1

Variables Affected

(% change from 

control)

Study 

Classification 

(MRID)

Rainbow trout 

(Oncorhynchos 

mykiss)

TGAI 

(95.8%)

Flowthrough

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). Mortality 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 EC50 was determined to be 0.63 mg a.i/L and this study is classified 

as acceptable. 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 EC50 was determined to be >0.82 mg a.i/L and 

this study is classified as acceptable. 

Additionally, in a water column toxicity with the freshwater 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 LC50 was determined to be >0.56 mg a.i/L and this study is classified as 

acceptable. 

42Table 4.3. Summary of acute toxicity data to freshwater invertebrates exposed to 

oxathiapiprolin

Species Exposure 

System

Test Substance 

(Purity)

EC50 (95% CI; 

slope)1

Acute 

Toxicity 

Classification2

Study 

Classification 

(MRID)

Water flea 

(Daphnia magna)

Static

TGAI (95.8%)

48-hr EC50: 0.63 mg/L 

(0.58 – 0.68; N/A)

Highly toxic

Acceptable

(49011316)

Freshwater midge 

(Chironomus 

riparius)

48-hr LC50: >0.56 

mg/L (N/A; N/A)

Acceptable 

(49011347)

Water flea 

Formulation 

(Oil dispersion) 

(10.4%)

48-hr EC50: >0.82 

mg/L (N/A; N/A)

Acceptable 

(49050533)

EC50 = 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

Although the acute toxicity classification is “highly toxic,” these studies did not elicit a 50% mortality response 

up to the limit of solubility. The designation is based on the standard EPA classification system.

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, length, 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 3rd

treatment concentration (mean measured 0.24 mg a.i/L). Similar effects were not 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 one 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. 

43Table 4.4. Summary of chronic toxicity data to freshwater invertebrates exposed to 

oxathiapiprolin

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.

44Table 4.5. Summary of acute toxicity data to estuarine/marine fish exposed to 

oxathiapiprolin1

Species Exposure 

System

Test Substance 

(Purity)

LC50 (95% CI; 

slope)1

Acute Toxicity 

Classification2

Study 

Classification 

(MRID)

Sheepshead 

minnow 

(Cyprinodon

variegatus)

Static TGAI (95.8%)

96-hr LC50: 

>0.65 mg/L 

(N/A; N/A)

Highly toxic Acceptable

(49011291)

LC50 = 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

Although the acute toxicity classification is “highly toxic,” these studies did not elicit a 50% mortality response 

up to the limit of solubility. The designation is based on the standard EPA classification system.

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 similar 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 significant 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. 

45Table 4.6. Summary of chronic toxicity data to estuarine/marine fish exposed to 

oxathiapiprolin

Species

Test 

Substance

(Purity)

Exposure 

system Endpoint1

Variables 

Affected (% 

change from 

control)

Study 

Classification 

(MRID)

Sheepshead minnow

(Cyprinodon 

variegatus)

TGAI 

(95.8%)

Flowthrough

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 LC50 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 (Crassostrea 

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 controls). The maximum mean 

percent shell deposition that occurred was 23% and therefore a definitive EC50 was not achieved. 

There were no clinical signs of toxicity observed during the study. The 96-hour EC50 was 

determined to be >0.33 mg a.i/L and this study is classified as acceptable. 

46Table 4.7. Summary of acute toxicity data to estuarine/marine invertebrates exposed to 

oxathiapiprolin

Species Exposure 

System

Test 

Substance 

(Purity)

LC/EC50 (95% CI; 

slope)1

Acute Toxicity 

Classification2

Study 

Classification 

(MRID)

Mysid shrimp 

(Americamysis 

bahia)

Static TGAI (95.8%) 96-hr LC50: >0.64 

mg/L (N/A; N/A)

Highly toxic

Acceptable

(49011328)

Eastern oyster 

(Crassostrea 

virginica)

Flow-through TGAI (95.8%) 96-hr EC50: >0.33 

mg/L (N/A; N/A)

Acceptable 

(49011329)

LC50/EC50 = 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

Although the acute toxicity classification is “highly toxic,” these studies did not elicit a 50% mortality response 

up to the limit of solubility. The designation is based on the standard EPA classification system.

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 0.12 mg a.i/L, respectively, and this study is classified as acceptable. 

47Table 4.8. Summary of chronic toxicity data to estuarine/marine invertebrates exposed to 

oxathiapiprolin

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 sediment-dwelling invertebrates (Table 4.9). 

In a chronic 28-day study with the freshwater midge (Chironomus riparius - MRID 49033228), 

test organisms were exposed in a spiked water sediment system to mean measured concentrations 

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 controls). Mean 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 the 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 

spiked water system rather than a spiked sediment system, which is the test system EPA prefers

for characterizing effects to benthic invertebrates. Additionally, EPA prefers a longer term (i.e.

60-day test) to characterize the effect on reproductive endpoints.

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 observed 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 solvent 

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 significant 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 concentrations 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 longer 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 suitable for quantitative 

risk assessment.

48Table 4.9. Summary of toxicity data to freshwater benthic invertebrates exposed to 

oxathiapiprolin

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

Development 

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) conducted with TGAI oxathiapiprolin and formulated product (oil dispersion, 10.4% a.i -

Table 4.10).

In the aquatic vascular plant toxicity study, Lemna 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 EC50 was not 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 EC50, 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 ranging 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 EC50, 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 exposed 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 significantly (p<0.05, 

24% effect)) reduced at the highest treatment concentration. The EC50, 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 EC50, 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 the 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 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, 42% effect) from the 

negative control at the highest treatment concentration. The 96-h EC50, 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) that 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 EC50, 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. 

 

49Table 4.10. Summary of toxicity data to vascular and non-vascular aquatic plants exposed to 

oxathiapiprolin

Species

Test 

Substance

(Purity)

Exposure 

system Endpoint1 Variables Affected

Study 

Classification 

(MRID)

Duckweed (Lemna 

gibba)

TGAI 

(95.8%)

Static 

renewal

7-d EC50: >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 EC50: >0.14 mg/L None Acceptable
81

Species

Test 

Substance

(Purity)

Exposure 

system Endpoint1 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 EC50: >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 flosaquae)

TGAI 

(98.9%) Static

96-hr EC50: >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 EC50: >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 EC50: >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

EC50 = 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.Terrestrial 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 TGAI 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 related 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 LD50 was therefore determined to be >2250 mg a.i/kg-bw and this study is 

classified as acceptable. Similarly, in an acute oral study conducted with the zebra finch (MRID 

49011284), birds were exposed to a single oral dose at 2250 mg a.i/kg-bw. There were no 
82

mortalities, clinical sings of toxicity (including regurgitation), or effects on body weight and food 

consumption observed during the study. The 14-day LD50 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 conducted 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 LD50 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 sensitive endpoint, both the formulation endpoint and the TGAI endpoint are nondefinitive, and therefore as no mortalities occurred in either study, the TGAI endpoint will be used 

for estimating risk.

50Table 4.15. Summary of acute oral toxicity studies for birds exposed to oxathiapiprolin 

Species Test Substance 

(Purity)

LD50 (mg/kg bw); 

(95% CI; 

slope)1,2

Toxicity 

Classification 

(MRID)

Study 

Classification 

(MRID)

Northern Bobwhite 

Quail (Colinus 

virginianus) TGAI (95.8%)

14-d LD50: >2250 

(N/A; N/A) Practically non-toxic Acceptable

(49011285)

Zebra finch

(Poephila guttata)

14-d LD50: >2250 

(N/A; N/A) Practically non-toxic Acceptable(49011284)

Northern Bobwhite 

Quail (Colinus 

virginianus)

Formulation (9.95% 

a.i – oil dispersion)

14-d LD50: >224 

(N/A; N/A) Practically non-toxic Acceptable

(49050530)

LD50 = 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 available for oxathiapiprolin (Table 4.16). In a study 

with the northern bobwhite quail (MRID 49011285), 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 or clinical signs of toxicity observed at all treatment levels. 

Additionally, there were no effects 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 duck 

(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 observed during the test. The 8-day 

LC50 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 LC50 was therefore determined to be >5640 mg product/kg diet and 

this study is classified as acceptable. Although the formulation, when adjusted 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.

51Table 4.16. Summary of sub-acute dietary toxicity data for birds exposed to oxathiapiprolin 

Species Test Substance 

(Purity)

LC50 mg/kg 

diet); (95% CI; 

slope)1

Toxicity 

Classification 

(MRID)

Study 

Classification 

(MRID)

Northern Bobwhite Quail 

(Colinus virginianus) TGAI (95.8%)

8-d LC50: >5640 

(N/A; N/A) Practically non-toxic Acceptable

(49011285)

Mallard duck

(Anas platyrhynchos)

8-d LD50: >5640

(N/A; N/A) Practically non-toxic Acceptable(49011286)

Northern Bobwhite Quail 

(Colinus virginianus)

Formulation (9.95% 

a.i –oil dispersion)

8-d LD50: >561.2 

(N/A; N/A) Practically non-toxic Acceptable(49050531)

LC50 = 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 for formulated oxathiapiprolin

There are two chronic reproduction studies available for oxathiapiprolin (Table 4.17). 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 treatment 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 effects determined for 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 exposed 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 body weight or food consumption. 

Additionally, there were no observations of clinical signs of toxicity during the study. For 

reproductive parameters, there were several effects 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 hatchability 

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 is 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 group (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 this, 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 hatchlings. Therefore, the 

NOAEC and LOAEC for this study are determined to be 920 and 1230 mg a.i/kg-diet, respectively. 

52Table 4.17. Summary of chronic toxicity data for birds exposed to oxathiapiprolin

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)

Bolded 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 LD50

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 (P1 and F1 adults), and up to post natal day 42 for F1 adults 

and F2 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. 

53Table 4.18. Summary of acute and chronic toxicity data for mammals exposed to 

oxathiapiprolin

Species Test 

substance Study Type Toxicity Endpoint1 Acute Toxicity Classification

Study 

Classification 

(MRID)

Laboratory 

rat (Rattus 

norvegicus)

TGAI

Acute oral 

toxicity

LD50: >5000 (N/A; N/A)

mg a.i/kg-bw

Practically nontoxicAcceptable 

(41850805)

Multi-generation 

reproductive 

toxicity

NOAEL: 10,000 ppm 

(1210 mg a.i/kg-bw/day)

LOAEL : >10000 ppm

--

Acceptable 

(49011186, 

49033235)

LD50 = 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 adult 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 concentrations 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 for 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 acute 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 toxicity study with oxathiapiprolin (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 for 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 component 

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, respectively (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, and 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 acute 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 4th 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. 

54Table 4.19. Summary of acute toxicity data for honey bees exposed to oxathiapiprolin

Stressor

% Active

Ingredient 

(a.i.)

Study Type Toxicity Endpoint1 Toxicity 

Classification

Study 

Classification 

(MRID)

Oxathiapiprolin

TGAI (95.8%)

Acute contact 48-hr LD50 : >104 μg 

a.i/bee (N/A; N/A) Practically 

non-toxic

Acceptable

(49011351) Acute oral 48-hr LC50 >42.0 μg 

a.i/bee (N/A; N/A)

Formulation 

(10.4% a.i. – oil 

dispersion)

Acute contact

48-hr LD50 : >981 μg 

product/bee (> 102 μg 

a.i/bee) (N/A; N/A) Practically 

non-toxic

Acceptable

(49050535)

Acute oral

48-hr LC50 >1349 μg 

product/bee (>140 μg 

a.i/bee) (N/A; N/A)

Formulation 

(101% - 200g/L 

SC 

formulation)

2

Acute contact

48-hr LD50 : >1075 μg 

product/bee (> 200 μg 

a.i/bee) (N/A; N/A) Practically 

non-toxic

Acceptable

(49050619)

Acute oral

48-hr LC50 >1344 μg 

product/bee (>250 μg 

a.i/bee) (N/A; N/A)

IN-E8S72 TGAI (99.8%)

Acute contact 48-hr LD50 : >100 μg 

a.i/bee (N/A; N/A) Practically 

non-toxic

Acceptable

(49033238) Acute oral 48-hr LC50 >109 μg 

a.i/bee (N/A; N/A)

IN-WR791 TGAI (99.5%)

Acute contact 48-hr LD50 : >100 μg 

a.i/bee (N/A; N/A) Practically 

non-toxic

Acceptable

(49033329) Acute oral 48-hr LC50 >56.2 μg 

a.i/bee (N/A; N/A)

LD50/LC50 = Lethal dose/concentration to 50% of the population, CI = confidence intervals, N/A = not applicable

Bolded values indicate the most sensitive endpoint used for oxathiapiprolin risk estimation. 1

Based on mean measured concentrations in terms of active ingredient

2

101% purity 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 bee 

(Apis 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 included 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 no 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 marked 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. However, 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 study 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.

55Table 4.20. Summary of semi-field study conducted with formulated oxathiapiprolin

Study Attribute Result Summary1

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 ≈ control (except 6 Days 

after application when all treatments significant reduced from control)
88

Study Attribute Result Summary1

Forager behavior Some behavioral abnormalities at all treatment concentrations that included single 

bees being observed motionless or with locomotion problems. All symptoms not 

considered treatment related based on similar control symptoms.

Brood development 1st CCA: treatments ≈ control

6th and 7th CCA (21 and 25 days after application): Colony sizes were significantly 

reduced for all treatments as compared to the control

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 compensation 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 were 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 as 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 data 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 BFD +10; ↓ brood compensation index at BFD+17 and 

BFD+23 1

Statistically 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 

intervals 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 for 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 to 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. Oilseed 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 elicited 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%, relative to the negative control, and neither effect was statisticallysignificant (p>0.05). The most sensitive monocot and dicot species could therefore not be 

determined due to a lack of toxic effects. The resultant EC25, NOAEC, and LOAEC values for 

monocots and dicots are >0.52, 0.52, and >0.52 lbs a.i./A, respectively. This study is classified 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 0.56 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 negative control, at the 0.062 lbs a.i./A treatment level but similar effects 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 monocot and dicot EC25, NOAEC, and 

LOAEC were >0.56, 0.56, and >0.56 lbs a.i/A, respectively. This study is classified as acceptable. 

56Table 4.22. Summary of toxicity data for terrestrial plants exposed to oxathiapiprolin

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 EC25: > 0.52

(N/A; N/A) NOAEC: 0.52; LOAEC: 

>0.52

None Acceptable

(49011398)

Multiple 

species

Vegetative 

Vigor

Monocot/Dicot : 21-d EC25: > 0.56 

(N/A; N/A) NOAEC: 0.56; LOAEC: 

>0.56

None Acceptable

(49011399)

EC25 = 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 

sensitivity 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 nontarget organisms and the need to consider 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:

Animals: 

• 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 regulatory 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. 

Risk presumptions, along with the calculation of the corresponding RQs and LOCs, are tabulated 

below:
91

57Table 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/LC50 or dose-based EEC/LD50 0.5

Acute Restricted Use Diet-based EEC/LC50 or dose-based EEC/LD50 (or LD50

< 50 mg/kg)

0.2

Acute Endangered Species Diet-based EEC/LC50 or dose-based EEC/LD50 0.1

Chronic Risk Diet or dose-based EEC/NOAEC 1

Aquatic Animals

Acute Risk EEC/LC50 or EC50 0.5

Acute Restricted Use EEC/LC50 or EC50 0.1

Acute Endangered Species EEC/LC50 or EC50 0.05

Chronic Risk EEC/NOAEC 1

Terrestrial and Semi-Aquatic Plants, and Aquatic Plants

Acute Risk EEC/EC25 1

Acute Endangered Species EEC/EC05 or NOAEC 1

Terrestrial Invertebrates

Acute risk to bees EEC (adult contact)/LD50 (adult contact)

EEC (adult or larval oral)/LD50 (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 mentioned 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 foliar 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 LC50 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 LC50 values for freshwater fish and estuarine/marine fish 

are >690 and >650 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), the resultant RQs are below 

all acute LOCs (endangered species, acute restricted use, and acute non-listed 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 an 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.

58Table 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

LC50: >690 μg 

a.i/L

Estuarine/marine 

fish

LC50: >650 μg a.i/L

Acute RQ Acute RQ

Fruiting vegetables PAvegetableNMC Soil applied 4.20 <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

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.

59Table 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)

Freshwater 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

Chronic 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 LC50 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 

LC50 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 risk 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.

60Table 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

LC50: >540 μg 

a.i/L

Estuarine/marine 

invertebrates

LC50: >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 oxathiapiprolin that would exceed the LOC. 

61Table 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 EC50. Chronic 

RQs are derived several 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 LC50), 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 EECs were compared against the 28-day NOAEC based on mean 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 vegetables, ginseng, tuberous 

vegetables, and ornamentals. 

There are no available sediment toxicity studies for estuarine/marine sediment dwelling 

invertebrates for risk estimation.

62Table 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 

RQ2

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 

RQ2

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 

RQ2

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 indicate an exceedance of an LOC 2

Based on peak pore water EEC divided by >540 ug a.i/L (EC50 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 water 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 EC50 values for vascular and nonvascular 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 EC50 and NOAEC values 

for vascular and non-vascular plants, all RQs were below the LOC of 1 (Table 5.7). For the

estimation of non-listed RQs for both vascular ad non-vascular plants, a definitive EC50 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

63Table 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

EC50 = >140 μg a.i/L

NOAEC = 140 μg a.i/L

Aquatic Vascular Plants

EC50 = >790 μg a.i/L

NOAEC = 58 μg a.i/L

Listed RQs2

Nonlisted

RQs3

Listed 

RQs3

Non-listed

RQs4

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 EC50

Non-target Terrestrial Animals 

Acute mammalian RQ values are calculated using the rat acute oral toxicity data (LD50 >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 LD50 = 10989, 8891, and 3846 mg/kg bw., 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 specify 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 chronic 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 LC50 values, respectively, that 

these RQs would be preceded by a “<” to present an upper bound “worst case,” scenario of risk. 

64
98

65Table 5.8. Acute Dietary-Based RQs for Birds of Different Feeding Classes Exposed to 

Oxathiapiprolin1 (Note: As a definitive acute dietary LC50 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

Broadleaf 

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

66Table 5.9. Chronic Dietary-Based RQs for Birds and Mammals of Different Feeding Classes

Exposed to Oxathiapiprolin1

Primary Feeding Strategy  Herbivores, Omnivores, and Granivores Insectivores

Dietary Items 

Short 

Grass

Tall 

Grass

Broadleaf 

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

67Table 5.10. Acute Dose-based RQ values for Birds and Mammals Exposed to Oxathiapiprolin1,2,3 (Note: As a definitive acute oral 

LD50 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 Grass

Tall Grass

Broad-leaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, pods, 

seeds, etc.

Short Grass

Tall Grass

Broadleaf 

Plants

Fruits, 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 0.02 0.02 <0.01 0.01 0.01 0.01 <0.01 0.03 0.01 <0.01 <0.01 <0.01 <0.01

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 estimate 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 beneficial 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 available 

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 toxicity 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 oral component 

of the available study did not achieve a definitive LD50 (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 applications of oxathiapiprolin are below the acute LOC of 0.4 

For soil applications, the maximum 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 LD50. The resultant RQ is 0.13. As 

the acute oral component of the available study did not achieve a definitive LD50 (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. 

68Table 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 estimate3 Briggs EEC4 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 LD50 of >42 μg a.i/bee and acute contact LD50 of >104 μg a.i/bee for parent 

oxathiapiprolin (MRID 49011351).

3

Derived from Briggs Model approach using Log KOW of 3.6 and KOC 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 EC25 values were higher than 

the highest treatment rate tested, for oxathiapiprolin. The highest application rates tested in these 

studies were approximately 2.2X the maximum single application rate of 0.25 lbs a.i/A proposed 

for oxathiapiprolin. Furthermore, 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

5.2. Risk Description – Interpretation 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 scenario 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 formulated 

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 toxicity 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 approximately 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 is 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 fish resulting from the proposed uses of 

oxathiapiprolin. 

69Table 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 vegetable 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 conducted 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 EC50 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 uses of oxathiapiprolin.
103

70Table 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 oxathiapiprolin 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 chronic 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 sediment 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 purposes 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 environmental fate data show 

that oxathiapiprolin persists 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 useful 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 

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50A46EB8E3A3AD0A27D2136D8
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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 relatively 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 water 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 magnitude. 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 endpoints 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 cannot 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 EC50 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), respectively which is approximately at the level of solubility of oxathiapiprolin. 

71Table 5.14. Summary of listed and non-listed RQs for vascular and non-vascular aquatic 

plants resulting from the highest peak EECs from the proposed 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

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D0FD8A0BE59D350341EDF74DC6
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Risks to Terrestrial Animals 

Birds and Mammals

The analysis conducted in risk estimation determined there to be no avian acute dose or dietarybased 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 similar 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). 

72Table 5.15. Summary of the acute and chronic risk profile for oxathiapiprolin for birds and 

mammals

Exposure Avian Dose-Based 

RQ

Avian DietaryBased RQMammalian DoseBased RQMammalian 

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 assumptions 

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, followed 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 transplant 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 conservative 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, effects 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 adult 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 honey 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 surrogate for pollen and nectar. 

Available plant metabolism studies indicate that the degradates IN-E8S72, IN-WR791, and INRZD74 were observed in crop field trials at limits above the limit of quantitation. Acute contact 

and oral toxicity data for two of these 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 Division (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 risk 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 Phacelia, 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 but 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 application 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 indication that under the tested conditions of a semi-field design, honey 

bee colonies showed recovery of multiple response variables, the proposed uses of oxathiapiprolin 

are not expected to significantly 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 EC25 values were higher than 

the highest treatment rate tested, for oxathiapiprolin. The highest application rates tested in these 

studies were approximately 2.2X the maximum single application rate of 0.25 lbs a.i/A proposed 

for oxathiapiprolin. Furthermore, 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 analysis was performed based on the log KOW 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 from dose 

or dietary-based RQs for birds and mammals ingesting oxathiapiprolin contaminated fish. All 

RQs were below <0.01.

5.3.Endocrine Effects

Under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality

Protection Act (FQPA), EPA is required to develop a screening program to determine whether 

certain substances (including all pesticide active and other ingredients) “may have an effect in 

humans that is similar to an effect produced by a naturally-occurring estrogen, or other such 

endocrine effects as the Administrator may designate.” Following the recommendations of its 

Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined 

that there was scientific basis for including, as part of the program, the androgen- and thyroid 

hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC’s 

recommendation that the Program include evaluations of potential effects in wildlife. For 

pesticide chemicals, EPA will use FIFRA, to the extent that effects in wildlife may help determine

whether a substance may have an effect in humans, and the FFDCA authority to require the

wildlife evaluations. As the science develops and the resources allow, screening of additional 

hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When 

the appropriate screening and or testing protocols being considered under the Agency’s Endocrine

Disruptor Screening Program have been developed, oxathiapiprolin may be subjected to 

additional screening and or testing to better characterize effects related to endocrine disruption.
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 benthic 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, at this current stage of the registration 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 Endangered 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-specific 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 information 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) Pesticide Registration 

Information SysteM (PRISM) listed 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 spatial 

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 weight) will be used to parameterize 

exposure estimates using a method consistent with currently used methods in the T-REX and THERPS models. 

Refinements will also include more detailed analyses of the registered uses and specific use 

patterns that result in 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 data 

(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 usage 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 habitats.

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 Risk 

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 action 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 extend to indirect 

effects upon listed species that depend upon that taxonomic group as a resource. In such cases, 

additional information on the biology of listed species, the locations of these species, and the 

locations of use sites are considered to determine 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 potentially 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 conducted 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 and 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 federal 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 

assessment 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 (Table ). 

Data on exposure and effects collected under field and laboratory conditions are evaluated to make 

determinations on the predictive utility of the direct effect screening assessment findings to listed 

species. 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 effects to federally listed taxa associated with direct or indirect effects 

from the proposed uses 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 No1 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 Yes2 Yes3

Estuarine/marine benthic organisms ND ND4 ND4

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 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 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 assessed, the 

highest RQ estimated was 1.01, marginally above the chronic LOC of 1.
112

VI. DESCRIPTION OF ASSUMPTIONS, LIMITATIONS, UNCERTAINTIES,

STRENGTHS AND DATA GAPS 

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 toxicity 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 frequency 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 application, 

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 modeling 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 estimates 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 pesticide. 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 provides 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 the standard runoff scenario assume a 

watershed area to water body volume ratio of 10 ha: 20,000 m3

. 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 volume 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 conditions. 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 habitats.

• 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 the 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 assessment 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 uncertainties 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 consider 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.

• Inhalation 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 toxicity 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.

• Age 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 juveniles 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 uses 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 overestimated, 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 needed 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 between 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 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. There 

is uncertainty in the toxicity of 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 marginal. 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 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. 

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 potential sublethal effects from 

prolonged oral exposure to oxathiapiprolin.
117

VII. REFERENCES

Environmental Fate Studies

MRID No. Author(s) Year Title

490112-50 Cleland, H. 2013

Aerobic soil metabolism of DPX-QGU42

Charles River Laboratories (UK)

DuPont-28071, Revision No. 1; GLP: Yes; Published: No

490111-55 McCorquodale, G. 2013

DPX-QGU42: Aerobic soil metabolism

Charles River Laboratories (UK)

DuPont-29443, Revision No. 1; GLP: Yes; Published: No 

490112-51 Manjunatha, S. 2011

Rate of degradation of 14C-DPX-QGU42 in four aerobic soils

Advinus Therapeutics Limited; DuPont-28072; GLP: Yes; 

Published: No

490112-57 Ravi, P.E. 2013a

Rate of degradation of [pyrazole-5-

14C]-IN-RAB06 in five aerobic 

soils; International Institute of Biotechnology and Toxicology 

(IIBAT); DuPont-35533, Revision No. 1; GLP: Yes; Published: No

490112-54

Stenzel, J.I.,

Schaefer, E.C. 2012

Rate of degradation of [14C]-IN-RAB06 in five aerobic soils

Wildlife International Ltd (USA); DuPont-32060; GLP: Yes; 

Published: No

490112-56 Sannappa, H. 2012

Rate of degradation of 14C-IN-RDT31 in five aerobic soils

Advinus Therapeutics Limited; DuPont-32062; GLP: Yes

Published: No

490112-55 Ravi, P.E. 2013b

Rate of degradation of [14C]-IN-E8S72 in five aerobic soils

International Institute of Biotechnology and Toxicology (IIBAT)

DuPont-32061, Revision No. 1; GLP: Yes; Published: No

490112-58 Yogeesha, S. 2012

Rate of degradation of 14C-IN-QPS10 in four aerobic soils

Advinus Therapeutics Limited; DuPont-32065; GLP: Yes

Published: No

490112-52

Anderson, C.,

Wardrope, L. 2012

DPX-QGU42: Anaerobic soil metabolism

Charles River Laboratories (UK); DuPont-31137; GLP: Yes

Published: No

490112-53 Cleland, H. 2013

Photodegradation of [14C]-DPX-QGU42 on moist and dry soil

Charles River Laboratories (UK); DuPont-28075, Revision No. 1

GLP: Yes; Published: No

490112-60

Doig, A.,

Just, G. 2012b

Terrestrial field dissipation study of DPX-QGU42 following a 

single application to bare ground - Lyon France 2009; Charles River 

Laboratories (UK); DuPont-27214; GLP: Yes; Published: No

490112-61

Doig, A.,

Just, G. 2012a 

Terrestrial field dissipation study of DPX-QGU42 following a single 

application to bare ground - Germany, 2009; Charles River 

Laboratories (UK); DuPont-27404; GLP: Yes; Published: No 

490112-68

Doig, A.,

Just, G.,

McConnell, K. 2012b

The field soil dissipation of DPX-QGU42 following a single 

application to bare ground – UK; Charles River Laboratories (UK)

DuPont-29819; GLP: Yes; Published: No

490112-69

Doig, A., Just, G., 

McConnell, K. 2012a 

Terrestrial field dissipation study of DPX-QGU42 following a single 

application to bare ground - Sevilla, Spain, 2010; Charles River 

Laboratories (UK); DuPont-29820; GLP: Yes; Published: No 
118

490112-63 Rice, F. 2012b

Terrestrial field dissipation of DPX-QGU42 fungicide on bare soil 

in New York, 2010, USA; ABC Laboratories, Inc. (Missouri); 

DuPont-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); DuPont29818; 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-QGU42 fungicide on bare soil in 

California, 2010, USA; ABC Laboratories, Inc. (Missouri); DuPont29823; GLP: Yes; Published: No

490112-64 Vincent, T.P. 2012

Terrestrial field dissipation of DPX-QGU42 fungicide on bare soil in 

Manitoba, 2010, Canada; ABC Laboratories, Inc. (Missouri)

DuPont-29814; GLP: Yes; Published: No

490112-65 Vincent, T.P. 2013a

Terrestrial field dissipation of DPX-QGU42 on bare soil in British 

Columbia, 2010, Canada; ABC Laboratories, Inc. (Missouri)

DuPont-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; 

Published: No

490112-70 Manjunatha, S. 2010

14C-DPX-QGU42: Batch equilibrium (adsorption/desorption) in five 

soils; Advinus Therapeutics Private Limited; DuPont-28425; GLP: 

Yes; Published: No

490112-71 Manjunatha, S. 2013

14C-DPX-QGU42: Batch equilibrium (adsorption/desorption) in a 

soil; Advinus Therapeutics Private Limited; DuPont-36141; GLP: 

Yes; Published: No

490112-75 Ravi, P.E. 2012

[

14C]-IN-E8S72: Batch equilibrium experiment in five soils

International Institute of Biotechnology and Toxicology (IIBAT); 

DuPont-32058; GLP: Yes; Published: No

490112-73 Sannappa, H. 2012a

14C-IN-RDT31: Batch equilibrium (adsorption/desorption) in five 

soils; Advinus Therapeutics Private Limited; DuPont-32059; GLP: 

Yes; Published: No

490112-74 Sannappa, H. 2012b

14C-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

14C-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 (Koc) and partition coefficient (Kow) by HPLC method

Advinus Therapeutics Limited; DuPont-33852; GLP: Yes; 

Published: No

490111-21 Anand, H.S. 2010

14C-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

[

14C]-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 [14C]-DPX-QGU42 in two 

water/sediment systems; Charles River Laboratories (UK); uPont28458, Revision No. 2; GLP: Yes; Published: No

490112-81 Wardrope, L. 2012a

Anaerobic aquatic metabolism of [14C]-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 Company. 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, INQPS10, IN-RDT31 and IN-RAB06 in Soil Using LC/MS/MS. 

Project Number: DUPONT/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 Analytical 

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 of 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 Wildlife 

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, MD. 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, 2011 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 September 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. 

Deierling. 

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 number: 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), Tamil 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. 

Deierling. 

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 Freshwater 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, Wilmington, 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, Wilmington, 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 Company, 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 study 

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 International 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 December 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 performed 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-RDT31 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 initiated 

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), Tamil 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 initiated 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 initiated 

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. Laboratory 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. Porch. 

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 DuPont35834. 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 February 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 IBACON 

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 Number 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 19457. 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 Subcapitata. 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, Wilmington, 

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 completed 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. 

2011 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 sponsored 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 14C DPX-QGU42: A Prolonged Sediment Toxicity Test with 

Chironomus Riparius Using Spiked Water.

49011348 Thomas, S.T., et al. 2013 14C 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-QGU42 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.

Fungicide 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 Residue 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 Test. 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 Science 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 Threatened 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 Assessment 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 Programs. 

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

1Appendix 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)

Maximum Final Comment MRID

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: C24H22F5N5O2S; MW: 539.53 g/mole

SMILES: 

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

Water solubility at 20oC: 0.175 mg/L; KOW= 3.6; pKa at 20oC:

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)-1H-pyrazol-1-yl]ethanone

CAS Number: 1151573-12-4; MW: 555.53 g/mole; 

Formula: C24H22F5N5O3S; Water solubility at 20oC: 1.04 mg/L; Log KOW= 2.95

Aerobic soil

6.8 (120) 6.8 (120) Loamy sand – [pyrazole-5-

14C] 

5.3 (120) 5.3 (120) Loamy sand – [thiazole-5- 49011250 14C] 

8.8 (90) 6.0 (134) Loamy sand – [isoxazoline-5-

14C]

9.4 (120) 9.4 (120) Loamy sand – [pyrazole-5- 49011155 14C] 

6.2 (7) 6.0 (120) Sandy loam – [pyrazole-5-

14C]

49011251

6.7 (120) 6.7 (120) Sandy loam – [thiazole-5-

14C]

5.7 (120) 5.7 (120) Silty clay loam – [pyrazole-5-

14C]

8.0 (7) 3.8 (120) Silty clay loam – [thiazole-5-

14C]

5.5 (60) 4.2 (120) Clay loam – [pyrazole-5-

14C]

5.3 (15) 4.2 (120) Clay loam – [thiazole-5-

14C]

5.1 (120) 5.1 (120) Sand – [pyrazole-5-

14C]
131

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

6.4 (120) 6.4 (120) Sand – [thiazole-5-

14C]

Anaerobic Soil 4.8 (90) 4.3 (120) Sandy loam – [pyrazole-5-14C]

3.5 (30) 3.1 (120) Sandy loam – [isoxazoline-5- 49011252 14C]

Soil Photolysis

5.7 (10) 5.2 (15) Sand – [pyrazole-5-

14C]

4.0 (15) 4.0 (15) Sand – [isoxazoline-5- 49011253 14C]

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 

CAS: 1-[2-[4-[4-[5-(2,6-Difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-oxoethyl]-

3-(trifluoromethyl)-1H-pyrazole-5-carboxylic acid; Formula: C24H20F5N5O4S; MW: 569.51 g/mole; water 

solubility: 32 mg/L; Log KOW = -0.05

Aerobic Soil

6.0 (90) 3.8 (120) Loamy sand – [pyrazole-5-

14C] 

4.4 (60) 2.3 (120) Loamy sand – [thiazole-5- 49011250 14C] 

7.6 (90) 0.37 (134) Loamy sand – [isoxazoline-5-

14C]

13.5 (90) 10.3 (120) Loamy sand – [pyrazole-5- 49011155 14C] 

6.2 (120) 6.2 (120) Sandy loam – [pyrazole-5-

14C]

49011251

7.7 (120) 7.7 (120) Sandy loam – [thiazole-5-

14C]

6.6 (60) 6.6 (120) Silty clay loam – [pyrazole-5-

14C]

5.1 (7) 3.6 (120) Silty clay loam – [thiazole-5-

14C]

7.3 (90) 5.0 (120) Clay loam – [pyrazole-5-

14C]

7.0 (30) 5.8 (120) Clay loam – [thiazole-5-

14C]

6.4 (120) 6.4 (120) Sand – [pyrazole-5-

14C]

6.5 (90) 6.1 (120) Sand – [thiazole-5-

14C]

Anaerobic Soil

4.7 (21) nd Sandy loam – [pyrazole-5-14C]

3.7 (21) nd Sandy loam – [isoxazoline-5- 49011252 14C]

Soil Photolysis

2.2 (7) 1.5 (13) Sand – [pyrazole-5-

14C]

4.5 (7) 1.2 (15) Sand – [isoxazoline-5- 49011253 14C]

Aerobic Aquatic

3.4 (38) 1.2 (99) Loamy sand – [pyrazole-5-

14C] – Water 

49011279

2.7 (60) nd Loamy sand – [pyrazole-5-

14C] – Sediment

5.6 (28) 1.2 (99) Loamy sand – [pyrazole-5-

14C] – Total System

4.2 (28) 1.0 (99) Loamy sand – [thiazole-5-

14C] – Water 

5.2 (28) 0.6 (99) Loamy sand – [thiazole-5-

14C] – Sediment

9.5 (28) 1.6 (99) Loamy sand – [thiazole-5-

14C] – Total System

2.4 (14) 0.5 (99) Silt loam – [pyrazole-5-

14C] – Water 

1.3 (28) nd (99) Silt loam – [pyrazole-5-

14C] – Sediment

2.7 (28) 0.5 (99) Silt loam – [pyrazole-5-

14C] – Total System
132

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

2.1 (7) 1.2 (99) Silt loam – [thiazole-5-

14C] – Water 

3.8 (99) 3.8 (99) Silt loam – [thiazole-5-

14C] – Sediment

5.0 (99) 5.0 (99) Silt loam – [thiazole-5-

14C] – 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)-1H-pyrazole-3-carboxylic acid; CAS Number: 129768-28-1; 

Formula: C5H3F3N2O2; MW: 150.10 g/mole; Water solubility: 28.24 g/L; Log KOW = -0.52

Aerobic Soil

6.7 (120) 6.7 (120) Loamy sand – [pyrazole-5-

14C] 49011155

6.3 (60) 1.9 (120) Sandy loam soil – [pyrazole-5-

14C]

49011251

4.9 (30) 4.1 (120) Silty clay loam – [pyrazole-5-

14C]

4.3 (60) 1.9 (190) Clay loam – [pyrazole-5-

14C]

4.6 (60) 2.0 (120) Sand – [pyrazole-5-

14C]

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-

14C] 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: C16H17F3N4O3S; 

MW: 402.40 g/mole; 

Log KOW: 0.25
133

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

Aqueous Photolysis

10.8 (15) 10.8 (15) pH 7 – [pyrazole-5-

14C]

49011122

14.0 (15) 14.0 (15) pH 7 – [thiazole-5-

14C] 

7.6 (15) 7.6 (15) Natural water – [pyrazole-5-

14C]

6.3 (15) 6.3 (15) Natural water – [thiazole-5-

14C] 

IN-RYJ52 (combined isomers IN-RYJ52-I1 plus IN-RYJ52-I2)

CAS: 1-[4-[4-[(1S,3S)-3-(2,6-Difluorophenyl)-1,3-dihydroxypropyl]-2-thiazolyl]-1-piperindyl]-2-[5-

methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone; 

Formula: C24H25F5N4O3S; MW: 544.55 g/mole;

IN-RYJ52-I1 Log KOW: 2.13; IN-RYJ52-I2 Log KOW: 2.24

Aerobic Aquatic

1.58 (60) 1.1 (90) Loamy sand – [pyrazole-5-

14C] – Water 

49011279

6.2 (99) 6.2 (99) Loamy sand – [pyrazole-5-

14C] – Sediment

7.3 (99) 7.3 (99) Loamy sand – [pyrazole-5-

14C] – Total System

0.4 (60) nd Loamy sand – [thiazole-5-

14C] – Water 

3.8 (28) 2.5 (99) Loamy sand – [thiazole-5-

14C] – Sediment

3.8 (28) 2.5 (99) Loamy sand – [thiazole-5-

14C] – Total System

6.1 (60) nd Silt loam – [pyrazole-5-

14C] – Water 

9.9 (60) 8.1 (99) Silt loam – [pyrazole-5-

14C] – Sediment

16.0 (60) 8.1 (99) Silt loam – [pyrazole-5-

14C] – Total System

3.4 (28) 0.3 (99) Silt loam – [thiazole-5-

14C] – Water 

8.8 (28) 2.7 (99) Silt loam – [thiazole-5-

14C] – Sediment

12.2 (28) 3.0 (99) Silt loam – [thiazole-5-

14C] – Total System

Anaerobic Aquatic

12.5 (60) 11.1 (100) Sand – [pyrazole-5-

14C] – Water 

49011280

9.2 (100) 9.2 (100) Sand – [pyrazole-5-

14C] – Sediment

21.2 (60) 20.3 (100) Sand – [pyrazole-5-

14C] – Total System

11.5 (100) 11.5 (100) Sand – [thiazole-5-

14C] – Water 

9.2 (100) 9.2 (100) Sand – [thiazole-5-

14C] – Sediment

20.7 (100) 20.7 (100) Sand – [thiazole-5-

14C] – Total System

9.3 (100) 9.3 (100) Silt loam – [pyrazole-5-

14C] – Water 

18.6 (100) 18.6 (100) Silt loam – [pyrazole-5-

14C] – Sediment

27.9 (100) 27.9 (100) Silt loam – [pyrazole-5-

14C] – Total System

9.2 (100) 9.2 (100) Silt loam – [thiazole-5-

14C] – Water 

20.6 (100) 20.5 (100) Silt loam – [thiazole-5-

14C] – Sediment

29.9 (100) 29.9 (100) Silt loam – [thiazole-5-

14C] – Total System

6.0 (100) 6.0 (100) Sand – [pyrazole-5-

14C] – Water 

49011281

5.4 (100) 5.4 (100) Sand – [pyrazole-5-

14C] – Sediment

11.4 (100) 11.4 (100) Sand – [pyrazole-5-

14C] – Total System

5.5 (100) 5.5 (100) Sand – [isoxazoline-5-

14C] – Water 
134

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

5.4 (100) 5.4 (100) Sand – [isoxazoline-5-

14C] – Sediment

10.9 (100) 10.9 (100) Sand – [isoxazoline-5-

14C] – Total System

9.9 (100) 9.9 (100) Silt loam – [pyrazole-5-

14C] – Water 

22.8 (100) 22.8 (100) Silt loam – [pyrazole-5-

14C] – Sediment

32.7 (100) 32.7 (100) Silt loam – [pyrazole-5-

14C] – Total System

10.3 (100) 10.3 (100) Silt loam – [isoxazoline-5-

14C] – Water 

20.8 (100) 20.8 (100) Silt loam – [isoxazoline-5-

14C]– Sediment

31.0 (100) 31.0 (100) Silt loam – [isoxazoline-5-

14C] – Total System

IN-S2K66

CAS: 1-[4-[4-[3-(2,6-Difluorophenyl)-1-hydroxypropyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-

(trifluoromethyl)-1H-pyrazol-1yl]ethanone; Formula: C24H25F5N4O2S; MW: 528.55 g/mole; Log KOW: 3.41

Aerobic Aquatic

nd nd Loamy sand – [pyrazole-5-

14C] – Water 

49011279

8.7 (99) 8.7 (99) Loamy sand – [pyrazole-5-

14C] – Sediment

8.7 (99) 8.7 (99) Loamy sand – [pyrazole-5-

14C] – Total System

nd nd Loamy sand – [thiazole-5-

14C] – Water 

1.5 (99) 1.5 (99) Loamy sand – [thiazole-5-

14C] – Sediment

1.5 (99) 1.5 (99) Loamy sand – [thiazole-5-

14C] – Total System

nd nd Silt loam – [pyrazole-5-

14C] – Water 

2.8 (60) 2.1 (99) Silt loam – [pyrazole-5-

14C] – Sediment

2.8 (60) 2.1 (99) Silt loam – [pyrazole-5-

14C] – Total System

nd nd Silt loam – [thiazole-5-

14C] – Water 

nd nd Silt loam – [thiazole-5-

14C] – Sediment

nd nd Silt loam – [thiazole-5-

14C] – Total System

Anaerobic Aquatic

2.6 (100) 2.6 (100) Sand – [thiazole-5-

14C] – Water 

49011280

8.6 (100) 8.6 (100) Sand – [thiazole-5-

14C] – Sediment

11.2 (100) 11.2 (100) Sand – [thiazole-5-

14C] – Total System

1.2 (100) 1.2 (100) Silt loam – [pyrazole-5-

14C] – Water 

9.0 (100) 9.0 (100) Silt loam – [pyrazole-5-

14C] – Sediment

10.1 (100) 10.1 (100) Silt loam – [pyrazole-5-

14C] – Total System

1.4 (100) 1.4 (100) Silt loam – [thiazole-5-

14C] – Water 

9.8 (100) 9.8 (100) Silt loam – [thiazole-5-

14C] – Sediment

11.1 (100) 11.1 (100) Silt loam – [thiazole-5-

14C] – Total System

2.7 (100) 2.7 (100) Sand – [pyrazole-5-

14C] – Water 

49011281

8.7 (100) 8.7 (100) Sand – [pyrazole-5-

14C] – Sediment

11.4 (100) 11.4 (100) Sand – [pyrazole-5-

14C] – Total System

2.2 (100) 2.2 (100) Sand – [isoxazoline-5-

14C] – Water 

8.0 (100) 8.0 (100) Sand – [isoxazoline-5-

14C] – Sediment

10.2 (100) 10.2 (100) Sand – [isoxazoline-5-

14C] – Total System

3.2 (2) 1.4 (100) Silt loam – [pyrazole-5-

14C] – Water 

11.6 (100) 11.6 (100) Silt loam – [pyrazole-5-

14C] – Sediment

13.0 (100) 13.0 (100) Silt loam – [pyrazole-5-

14C] – Total System

0.9 (0) 0.9 (100) Silt loam – [isoxazoline-5-

14C] – Water 

9.9 (100) 9.9 (100) Silt loam – [isoxazoline-5-

14C]– Sediment
135

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

10.7 (100) 10.7 (100) Silt loam – [isoxazoline-5-

14C] – Total System

Aerobic Soil

1.7 (90) 1.5 (120) Loamy sand – [pyrazole-5-

14C] 

1.5 (60) 1.1 (120) Loamy sand – [thiazole-5- 49011250 14C] 

1.6 (120) 1.4 (134) Loamy sand – [isoxazoline-5-

14C]

1.6 (120) 1.6 (120) Loamy sand – [pyrazole-5- 49011155 14C] 

1.2 (120) 1.2 (120) Sandy loam soil – [pyrazole-5-

14C]

49011251

<LOQ (120) <LOQ (120) Sandy loam – [thiazole-5-

14C]

1.5 (15) 1.3 (120) Silty clay loam – [pyrazole-5-

14C]

2.5 (90) 2.5 (120) Silty clay loam – [thiazole-5-

14C]

1.3 (90) 1.3 (120) Clay loam – [pyrazole-5-

14C]

1.3 (90) <LOQ (120) Clay loam – [thiazole-5-

14C]

1.5 (60) 1.4 (120) Sand – [pyrazole-5-

14C]

<LOQ (120) <LOQ (120) Sand – [thiazole-5-

14C]

Aerobic Aquatic

1.5 (99) 1.5 (99) Loamy sand – [pyrazole-5-

14C] – Water 

49011279

4.1 (99) 4.1 (99) Loamy sand – [pyrazole-5-

14C] – Sediment

5.6 (99) 5.6 (99) Loamy sand – [pyrazole-5-

14C] – Total System

1.3 (99) 1.3 (99) Loamy sand – [thiazole-5-

14C] – Water 

10.5 (99) 10.5 (99) Loamy sand – [thiazole-5-

14C] – Sediment

11.8 (99) 11.8 (99) Loamy sand – [thiazole-5-

14C] – Total System

0.5 (7) 0.3 (99) Silt loam – [pyrazole-5-

14C] – Water 

7.5 (99) 7.5 (99) Silt loam – [pyrazole-5-

14C] – Sediment

7.7 (99) 7.5 (99) Silt loam – [pyrazole-5-

14C] – Total System

0.6 (14) nd (99) Silt loam – [thiazole-5-

14C] – Water 

9.1 (60) 3.2 (99) Silt loam – [thiazole-5-

14C] – Sediment

9.1 (60) 3.2 (99) Silt loam – [thiazole-5-

14C] – Total System

Anaerobic Aquatic

1.1 (28) 0.9 (100) Sand – [pyrazole-5-

14C] – Water 

49011280

4.5 (100) 4.5 (100) Sand – [pyrazole-5-

14C] – Sediment

5.4 (100) 5.4 (100) Sand – [pyrazole-5-

14C] – Total System

1.4 (60) 0.8 (100) Sand – [thiazole-5-

14C] – Water 

3.5 (100) 3.5 (100) Sand – [thiazole-5-

14C] – Sediment

4.3 (100) 4.3 (100) Sand – [thiazole-5-

14C] – Total System

0.9 (100) 0.9 (100) Silt loam – [pyrazole-5-

14C] – Water 

4.3 (100) 4.3 (100) Silt loam – [pyrazole-5-

14C] – Sediment

5.2 (100) 5.2 (100) Silt loam – [pyrazole-5-

14C] – Total System

0.7 (60) 0.2 (100) Silt loam – [thiazole-5-

14C] – Water 

4.3 (100) 4.3 (100) Silt loam – [thiazole-5-

14C] – Sediment

4.5 (100) 4.5 (100) Silt loam – [thiazole-5-

14C] – Total System

1.0 (100) 1.0 (100) Sand – [pyrazole-5-

14C] – Water 

49011281

6.1 (100) 6.1 (100) Sand – [pyrazole-5-

14C] – Sediment

7.0 (100) 7.0 (100) Sand – [pyrazole-5-

14C] – Total System

1.2 (60) 0.6 (100) Sand – [isoxazoline-5-

14C] – Water 

6.9 (60) 7.1 (100) Sand – [isoxazoline-5-

14C] – Sediment

8.0 (60) 7.7 (100) Sand – [isoxazoline-5-

14C] – Total System

0.5 (100) 0.5 (100) Silt loam – [pyrazole-5-

14C] – Water 

5.1 (60) 5.0 (100) Silt loam – [pyrazole-5-

14C] – Sediment

5.1 (60) 5.4 (100) Silt loam – [pyrazole-5-

14C] – Total System

0.8 (100) 0.8 (100) Silt loam – [isoxazoline-5-

14C] – Water 

5.8 (100) 5.8 (100) Silt loam – [isoxazoline-5-

14C]– Sediment

6.6 (100) 6.6 (100) Silt loam – [isoxazoline-5-

14C] – Total System
136

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

IN-Q7D41

CAS: 1-[4-[4-[5-(2,6-Difluorophenyl)-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-

(trifluoromethyl)-1H-pyrazol-1-yl]ethanone; CAS Number: 1148046-53-0; Formula: C24H20F5N5O2S

MW: 537.13 g/mole; Water solubility: n/a; Log KOW: 4.31; SMILES:

CC1=CC(=NN1CC(=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-

14C] 

1.5 (60) 1.1 (120) Loamy sand – [thiazole-5- 49011250 14C] 

1.6 (120) 1.4 (134) Loamy sand – [isoxazoline-5-

14C]

1.6 (120) 1.6 (120) Loamy sand – [pyrazole-5- 49011155 14C] 

1.2 (120) 1.2 (120) Sandy loam soil – [pyrazole-5-

14C]

49011251

<LOQ (120) <LOQ (120) Sandy loam – [thiazole-5-

14C]

1.5 (15) 1.3 (120) Silty clay loam – [pyrazole-5-

14C]

2.5 (90) 2.5 (120) Silty clay loam – [thiazole-5-

14C]

1.3 (90) 1.3 (120) Clay loam – [pyrazole-5-

14C]

1.3 (90) <LOQ (120) Clay loam – [thiazole-5-

14C]

1.5 (60) 1.4 (120) Sand – [pyrazole-5-

14C]

<LOQ (120) <LOQ (120) Sand – [thiazole-5-

14C]

Aerobic Aquatic

1.5 (99) 1.5 (99) Loamy sand – [pyrazole-5-

14C] – Water 

49011279

4.1 (99) 4.1 (99) Loamy sand – [pyrazole-5-

14C] – Sediment

5.6 (99) 5.6 (99) Loamy sand – [pyrazole-5-

14C] – Total System

1.3 (99) 1.3 (99) Loamy sand – [thiazole-5-

14C] – Water 

10.5 (99) 10.5 (99) Loamy sand – [thiazole-5-

14C] – Sediment

11.8 (99) 11.8 (99) Loamy sand – [thiazole-5-

14C] – Total System

0.5 (7) 0.3 (99) Silt loam – [pyrazole-5-

14C] – Water 

7.5 (99) 7.5 (99) Silt loam – [pyrazole-5-

14C] – Sediment

7.7 (99) 7.5 (99) Silt loam – [pyrazole-5-

14C] – Total System

0.6 (14) nd (99) Silt loam – [thiazole-5-

14C] – Water 

9.1 (60) 3.2 (99) Silt loam – [thiazole-5-

14C] – Sediment

9.1 (60) 3.2 (99) Silt loam – [thiazole-5-

14C] – Total System

Anaerobic Aquatic

1.1 (28) 0.9 (100) Sand – [pyrazole-5-

14C] – Water 

49011280

4.5 (100) 4.5 (100) Sand – [pyrazole-5-

14C] – Sediment

5.4 (100) 5.4 (100) Sand – [pyrazole-5-

14C] – Total System

1.4 (60) 0.8 (100) Sand – [thiazole-5-

14C] – Water 

3.5 (100) 3.5 (100) Sand – [thiazole-5-

14C] – Sediment

4.3 (100) 4.3 (100) Sand – [thiazole-5-

14C] – Total System

0.9 (100) 0.9 (100) Silt loam – [pyrazole-5-

14C] – Water 

4.3 (100) 4.3 (100) Silt loam – [pyrazole-5-

14C] – Sediment

5.2 (100) 5.2 (100) Silt loam – [pyrazole-5-

14C] – Total System

0.7 (60) 0.2 (100) Silt loam – [thiazole-5-

14C] – Water 

4.3 (100) 4.3 (100) Silt loam – [thiazole-5-

14C] – Sediment

4.5 (100) 4.5 (100) Silt loam – [thiazole-5-

14C] – Total System
137

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

1.0 (100) 1.0 (100) Sand – [pyrazole-5-

14C] – Water 

49011281

6.1 (100) 6.1 (100) Sand – [pyrazole-5-

14C] – Sediment

7.0 (100) 7.0 (100) Sand – [pyrazole-5-

14C] – Total System

1.2 (60) 0.6 (100) Sand – [isoxazoline-5-

14C] – Water 

6.9 (60) 7.1 (100) Sand – [isoxazoline-5-

14C] – Sediment

8.0 (60) 7.7 (100) Sand – [isoxazoline-5-

14C] – Total System

0.5 (100) 0.5 (100) Silt loam – [pyrazole-5-

14C] – Water 

5.1 (60) 5.0 (100) Silt loam – [pyrazole-5-

14C] – Sediment

5.1 (60) 5.4 (100) Silt loam – [pyrazole-5-

14C] – Total System

0.8 (100) 0.8 (100) Silt loam – [isoxazoline-5-

14C] – Water 

5.8 (100) 5.8 (100) Silt loam – [isoxazoline-5-

14C]– Sediment

6.6 (100) 6.6 (100) Silt loam – [isoxazoline-5-

14C] – Total System

IN-QFD61

CAS: 1-[4-(4-Acetyl-2-thiazolyl)-1-piperindyl]-

2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone

CAS Number: 1152179-07-1; 

Formula: C17H19F3N4O2S

MW: 400.43 g/mole; Log KOW: 2.05

Anaerobic Aquatic

16.8 (60) 10.5 (100) Sand – [pyrazole-5-

14C] – Water 

49011280

3.4 (60) 2.1 (100) Sand – [pyrazole-5-

14C] – Sediment

20.2 (60) 12.6 (100) Sand – [pyrazole-5-

14C] – Total System

15.6 (60) 9.8 (100) Sand – [thiazole-5-

14C] – Water 

2.5 (100) 2.5 (100) Sand – [thiazole-5-

14C] – Sediment

17.6 (60) 12.2 (100) Sand – [thiazole-5-

14C] – Total System

4.7 (100) 4.7 (100) Silt loam – [pyrazole-5-

14C] – Water 

1.2 (28) 0.6 (100) Silt loam – [pyrazole-5-

14C] – Sediment

5.3 (100) 5.3 (100) Silt loam – [pyrazole-5-

14C] – Total System

5.8 (100) 5.8 (100) Silt loam – [thiazole-5-

14C] – Water 

1.1 (28) 1.1 (100) Silt loam – [thiazole-5-

14C] – Sediment

6.9 (100) 6.9 (100) Silt loam – [thiazole-5-

14C] – Total System

8.8 (60) 5.8 (100) Sand – [pyrazole-5-

14C] – Water 

49011281

2.5 (100) 2.5 (100) Sand – [pyrazole-5-

14C] – Sediment

10.2 (60) 8.3 (100) Sand – [pyrazole-5-

14C] – Total System

6.4 (100) 6.4 (100) Silt loam – [pyrazole-5-

14C] – Water 

1.7 (100) 1.7 (100) Silt loam – [pyrazole-5-

14C] – Sediment

8.1 (100) 8.1 (100) Silt loam – [pyrazole-5-

14C] – Total System

IN-S2K67

O

CH3

S

N N

O

N

N

CH3

F

F

F
138

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

CAS: 1-[4-[4-(1-Hydroxyethyl)-2-thiazolyl)-1-piperindyl]-

2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone

CAS Number: N/A; Formula: C17H21F3N4O2S

MW: 402.44 g/mole; Log KOW: 1.56

Anaerobic Aquatic

8.7 (60) 3.7 (100) Sand – [pyrazole-5-

14C] – Water 

49011280

4.9 (60) 2.6 (100) Sand – [pyrazole-5-

14C] – Sediment

13.6 (60) 6.3 (100) Sand – [pyrazole-5-

14C] – Total System

5.4 (100) 5.4 (100) Sand – [thiazole-5-

14C] – Water 

2.9 (100) 2.9 (100) Sand – [thiazole-5-

14C] – Sediment

8.3 (100) 8.3 (100) Sand – [thiazole-5-

14C] – Total System

0.7 (60) 0.7 (100) Silt loam – [pyrazole-5-

14C] – Water 

0.6 (60) 0.6 (100) Silt loam – [pyrazole-5-

14C] – Sediment

1.3 (60) 1.3 (100) Silt loam – [pyrazole-5-

14C] – Total System

0.9 (100) 0.9 (100) Silt loam – [thiazole-5-

14C] – Water 

0.9 (100) 0.9 (100) Silt loam – [thiazole-5-

14C] – Sediment

1.8 (100) 1.8 (100) Silt loam – [thiazole-5-

14C] – Total System

5.7 (100) 5.7 (100) Sand – [pyrazole-5-

14C] – Water 

49011281

3.6 (100) 3.6 (100) Sand – [pyrazole-5-

14C] – Sediment

9.3 (100) 9.3 (100) Sand – [pyrazole-5-

14C] – Total System

1.1 (100) 1.1 (100) Silt loam – [pyrazole-5-

14C] – Water 

1.2 (100) 1.2 (100) Silt loam – [pyrazole-5-

14C] – Sediment

2.4 (100) 2.4 (100) Silt loam – [pyrazole-5-

14C] – 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: C24H23F5N4O3S

MW: 542.53 g/mole; 

Log KOW: 2.78

Aerobic Aquatic

2.9 (7) 2.9 (99) Loamy sand – [pyrazole-5-

14C] – Water 

49011279

4.3 (99) 4.3 (99) Loamy sand – [pyrazole-5-

14C] – Sediment

7.2 (99) 7.2 (99) Loamy sand – [pyrazole-5-

14C] – Total System

3.6 (99) 3.6 (99) Loamy sand – [thiazole-5-

14C] – Water 

5.2 (28) 2.4 (99) Loamy sand – [thiazole-5-

14C] – Sediment

7.2 (14) 6.0 (99) Loamy sand – [thiazole-5-

14C] – Total System

3.8 (60) 1.1 (99) Silt loam – [pyrazole-5-

14C] – Water 

OH

CH3

S

N N

O

N

N

CH3

F

F

F

O OH

S

N N

O

N

N

CH3

F

F

F

F

F
139

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

8.6 (14) 5.5 (99) Silt loam – [pyrazole-5-

14C] – Sediment

10.4 (14) 6.6 (99) Silt loam – [pyrazole-5-

14C] – Total System

2.9 (14) 0.1 (99) Silt loam – [thiazole-5-

14C] – Water 

7.8 (60) 3.2 (99) Silt loam – [thiazole-5-

14C] – Sediment

9.6 (28) 3.3 (99) Silt loam – [thiazole-5-

14C] – Total System

Anaerobic Aquatic

6.3 (28) 2.7 (100) Sand – [pyrazole-5-

14C] – Water 

49011280

3.0 (100) 3.0 (100) Sand – [pyrazole-5-

14C] – Sediment

9.1 (28) 5.7 (100) Sand – [pyrazole-5-

14C] – Total System

4.2 (60) 2.9 (100) Sand – [thiazole-5-

14C] – Water 

2.8 (100) 2.8 (100) Sand – [thiazole-5-

14C] – Sediment

7.0 (60) 5.7 (100) Sand – [thiazole-5-

14C] – Total System

3.4 (60) 2.8 (100) Silt loam – [pyrazole-5-

14C] – Water 

6.1 (60) 3.8 (100) Silt loam – [pyrazole-5-

14C] – Sediment

9.6 (60) 6.7 (100) Silt loam – [pyrazole-5-

14C] – Total System

3.2 (28) 0.9 (100) Silt loam – [thiazole-5-

14C] – Water 

6.3 (60) 3.5 (100) Silt loam – [thiazole-5-

14C] – Sediment

8.8 (60) 4.5 (100) Silt loam – [thiazole-5-

14C] – Total System

11.6 (30) 1.9 (100) Sand – [pyrazole-5-

14C] – Water 

49011281

5.0 (30) 2.6 (100) Sand – [pyrazole-5-

14C] – Sediment

16.6 (30) 4.5 (100) Sand – [pyrazole-5-

14C] – Total System

7.3 (30) 2.0 (100) Sand – [isoxazoline-5-

14C] – Water 

3.7 (60) 2.5 (100) Sand – [isoxazoline-5-

14C] – Sediment

10.9 (30) 4.5 (100) Sand – [isoxazoline-5-

14C] – Total System

3.3 (60) 1.1 (100) Silt loam – [pyrazole-5-

14C] – Water 

5.6 (60) 3.0 (100) Silt loam – [pyrazole-5-

14C] – Sediment

8.9 (60) 4.0 (100) Silt loam – [pyrazole-5-

14C] – Total System

3.9 (30) 2.6 (100) Silt loam – [isoxazoline-5-

14C] – Water 

6.0 (60) 3.7 (100) Silt loam – [isoxazoline-5-

14C]– Sediment

9.9 (60) 6.3 (100) Silt loam – [isoxazoline-5-

14C] – Total System

2,6-DFBA / IN-YY147

CAS: 2,6-diflurobenzoic acid; CAS Number: 385-00-2; Formula: C7H4F2O2; MW: 158.11 g/mole

Anaerobic Aquatic

15.5 

(100)

15.5 

(100) Sand – [isoxazoline-5-

14C] – Water 

49011281

2.7 (100) 2.7 (100) Sand – [isoxazoline-5-

14C] – Sediment

18.2 

(100)

18.2 

(100) Sand – [isoxazoline-5-

14C] – Total System

7.9 (100) 7.9 (100) Silt loam – [isoxazoline-5-

14C] – Water 

2.4 (100) 2.4 (100) Silt loam – [isoxazoline-5-

14C]– Sediment

10.3 

(100)

10.3 

(100)

Silt loam – [isoxazoline-5-

14C] – Total 

System

Minor Degradates

HO

O

F

F
140

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

IN-QPS10 

CAS: 4-[4-[5-(2,6-Difluorophenyl)-4,5-dihydro-3-isoxazolyl)-2-thiazolyl]piperidine

CAS Number: 1148104-71-5

Formula: C17H17F2N3OS

MW: 349.41 g/mole

Log KOW: -2.02

Aerobic Soil

NA NA Loamy sand – [pyrazole-5-

14C] 

7.2 (90) 3.9 (120) Loamy sand – [thiazole-5- 49011250 14C] 

2.9 (90) 1.2 (134) Loamy sand – [isoxazoline-5-

14C] 49011155

<LOQ (120) <LOQ (120) Sandy loam – [thiazole-5-

14C]

49011251

8.7 (60) 6.3 (120) Silty clay loam – [thiazole-5-

14C] 

3.2 (120) 3.2 (120) Clay loam – [thiazole-5-

14C]

2.7 (90) <LOQ (120) Sand – [thiazole-5-

14C] 

Anaerobic Soil 1.9 (30) nd Sandy loam – [isoxazoline-5-

14C] 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)-1H-pyrazole-1-acetic acid

CAS Number: 345637-71-0; Formula: C7H7F3N2O2; 

MW: 208.14 g/mole

Aerobic soil

Anaerobic Soil Observed but not quantified

Soil Photolysis

IN-RLD51 

OH

O

N

N

CH3

F

F

F
141

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

CAS: 1-[2-[5-Methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]acetyl]-4-piperidinecarboxylic acid

CAS Number: 922516-34-5

Formula: C13H16F3N3O3

MW: 319.29 g/mole

Aerobic Soil

2.8 (60) 1.7 (120) Sandy loam soil – [pyrazole-5-

14C]

49011251

3.6 (60)

<LOQ 

(120) Silty clay loam – [pyrazole-5-

14C]

2.6 (120) 2.6 (120) Clay loam – [pyrazole-5-

14C]

3.3 (120) 3.3 (120) Sand – [pyrazole-5-

14C]

Soil Photolysis

2.8 (10) nd Sand – [pyrazole-5-

14C]

0.6 (7) nd Sand – [isoxazoline-5- 49011253 14C]

Aqueous photolysis 5.4 (6) 3.7 (15) pH 7 – [pyrazole-5-

14C] 49011122

IN-RSA90

CAS: 1-[2-(5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl)acetyl]-4-piperidinecarboxamide

Formula: C13H17F3N4O2

MW: 318.30 g/mole

Soil Photolysis 3.2 (10) 1.2 (15) Sand – [pyrazole-5-

14C] 49011253

Aqueous Photolysis 5.2 (15) 5.2 (15) pH 7 – [pyrazole-5-

14C] 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: C24H21F5N4O2S; MW: 524.52 g/mole.

Anaerobic Aquatic

0.8 (60) 0.3 (100) Sand – [pyrazole-5-

14C] – Water 

49011280

1.5 (100) 1.5 (100) Sand – [pyrazole-5-

14C] – Sediment

2.0 (60) 1.8 (100) Sand – [pyrazole-5-

14C] – Total System

0.4 (100) 0.4 (100) Sand – [thiazole-5-

14C] – Water 

1.7 (100) 1.7 (100) Sand – [thiazole-5-

14C] – Sediment

OH

O N

O

N

N

CH3

F

F

F

NH2

O N

O

N

N

CH3

F

F

F

O

S

N N

O

N

N

CH3

F

F

F

F

F
142

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

2.1 (100) 2.1 (100) Sand – [thiazole-5-

14C] – Total System

nd nd Silt loam – [pyrazole-5-

14C] – Water 

2.3 (100) 2.3 (100) Silt loam – [pyrazole-5-

14C] – Sediment

2.3 (100) 2.3 (100) Silt loam – [pyrazole-5-

14C] – Total System

0.3 (100) 0.3 (100) Silt loam – [thiazole-5-

14C] – Water 

1.7 (100) 1.7 (100) Silt loam – [thiazole-5-

14C] – Sediment

2.0 (100) 2.0 (100) Silt loam – [thiazole-5-

14C] – Total System

Other Degradates: CO2

Aerobic Soil

0.33 (120) 0.33 (120) Loamy sand – [pyrazole-5-

14C] 

11.8 (120) 11.8 (120) Loamy sand – [thiazole-5- 49011250 14C] 

5.0 (134) 5.0 (134) Loamy sand – [isoxazoline-5-

14C]

6.6 (120) 6.6 (120) Loamy sand – [pyrazole-5- 49011155 14C] 

<LOQ (120) <LOQ (120) Sandy loam soil – [pyrazole-5-

14C]

49011251

<LOQ (120) <LOQ (120) Sandy loam – [thiazole-5-

14C]

<LOQ (120) <LOQ (120) Silty clay loam – [pyrazole-5-

14C]

0.4 (60) 0.4 (120) Silty clay loam – [thiazole-5-

14C]

<LOQ (120) <LOQ (120) Clay loam – [pyrazole-5-

14C]

<LOQ (120) <LOQ (120) Clay loam – [thiazole-5-

14C]

<LOQ (120) <LOQ (120) Sand – [pyrazole-5-

14C]

<LOQ (120) <LOQ (120) Sand – [thiazole-5-

14C]

Anaerobic Soil

1.5 (30) 1.5 (120) Sandy loam – [pyrazole-5-14C]

3.0 (60) 3.0 (120) Sandy loam – [isoxazoline-5- 49011252 14C] 

Soil Photolysis

<LOQ (15) <LOQ (15) Sand – [pyrazole-5-

14C]

<LOQ (15) <LOQ (15) Sand – [isoxazoline-5- 49011253 14C]

Aerobic Aquatic

0.2 (99) 0.2 (99) Loamy sand – [pyrazole-5-

14C]

49011279

7.2 (99) 7.2 (99) Loamy sand – [thiazole-5-

14C] 

0.4 (60) 0.4 (99) Silt loam – [pyrazole-5-

14C]

6.8 (99) 6.8 (99) Silt loam – [thiazole-5-

14C] 

Anaerobic Aquatic

<LOQ (100) <LOQ (100) Sand – [pyrazole-5-

14C]

49011280

<LOQ (100) <LOQ (100) Sand – [thiazole-5-

14C]

<LOQ (100) <LOQ (100) Silt loam – [pyrazole-5-

14C]

0.1 (100) 0.1 (100) Silt loam – [thiazole-5-

14C]

<LOQ (100) <LOQ (100) Sand – [pyrazole-5-

14C]

49011281

0.3 (100) 0.3 (100) Sand – [isoxazoline-5-

14C] 

<LOQ (100) <LOQ (100) Silt loam – [pyrazole-5-

14C]

0.7 (100) 0.7 (100) Silt loam – [isoxazoline-5-

14C] 

Unidentified polar radioactivity2

Aerobic Soil

3.6 (120) 3.6 (120) Loamy sand – [pyrazole-5-

14C] 

NA NA Loamy sand – [thiazole-5- 49011250 14C] 

Aqueous Photo. 10.2 (15) 10.2 (15) pH 7 – [isoxazoline-5-

14C] 49011122

Aerobic Aquatic

14.6 (99) 14.6 (99) Loamy sand – [pyrazole-5-

14C] – Water 

49011279

5.9 (60) 5.8 (99) Loamy sand – [pyrazole-5-

14C] – Sediment

20.4 (99) 20.4 (99)

Loamy sand – [pyrazole-5-

14C] – Total 

System

12.3 (99) 12.3 (99) Loamy sand – [thiazole-5-

14C] – Water 

9.5 (28) 4.2 (99) Loamy sand – [thiazole-5-

14C] – Sediment

16.5 (99) 16.5 (99)

Loamy sand – [thiazole-5-

14C] – Total 

System
143

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

13.7 (99) 13.7 (99) Silt loam – [pyrazole-5-

14C] – Water 

6.0 (99) 6.0 (99) Silt loam – [pyrazole-5-

14C] – Sediment

19.8 (99) 19.8 (99) Silt loam – [pyrazole-5-

14C] – Total System

1.3 (60) 1.3 (99) Silt loam – [thiazole-5-

14C] – Water 

6.9 (28) 5.4 (99) Silt loam – [thiazole-5-

14C] – Sediment

8.0 (28) 6.6 (99) Silt loam – [thiazole-5-

14C] – Total System

Unidentified non-polar radioactivity2

Aerobic Soil

25.9 (120) 25.9 (120) Loamy sand – [pyrazole-5-

14C] 

NA NA Loamy sand – [thiazole-5- 49011250 14C] 

Aqueous Photo. 22.4 (15) 22.4 (15) pH 7 – [isoxazoline-5-

14C] 49011122

Aerobic Aquatic

9.2 (99) 9.2 (99) Loamy sand – [pyrazole-5-

14C] – Water 

49011279

10.1 (99) 10.1 (99) Loamy sand – [pyrazole-5-

14C] – Sediment

19.3 (99) 19.3 (99) Loamy sand – [pyrazole-5-

14C] – Total System

6.3 (28) 5.8 (99) Loamy sand – [thiazole-5-

14C] – Water 

11.3 (99) 11.3 (99) Loamy sand – [thiazole-5-

14C] – Sediment

17.1 (99) 17.1 (99) Loamy sand – [thiazole-5-

14C] – Total System

7.3 (14) 4.9 (99) Silt loam – [pyrazole-5-

14C] – Water 

9.6 (60) 6.5 (99) Silt loam – [pyrazole-5-

14C] – Sediment

15.1 (60) 11.4 (99) Silt loam – [pyrazole-5-

14C] – Total System

6.7 (60) 1.9 (99) Silt loam – [thiazole-5-

14C] – Water 

6.5 (99) 6.5 (99) Silt loam – [thiazole-5-

14C] – Sediment

9.6 (28) 8.4 (99) Silt loam – [thiazole-5-

14C] – Total System

Unidentified radioactivity2

Aerobic Soil

NA NA Loamy sand – [pyrazole-5-

14C] 

18.8 (90) 14.9 (120) Loamy sand – [thiazole-5- 49011250 14C] 

6.2 (134) 6.2 (134) Loamy sand – [isoxazoline-5-

14C]

12.3 (120) 12.3 (120) Loamy sand – [pyrazole-5- 49011155 14C] 

19.9 (60) 10.1 (120) Sandy loam soil – [pyrazole-5-

14C]

49011251

13.1 (30) 10.3 (120) Sandy loam – [thiazole-5-

14C]

25.8 (90) 14.9 (120) Silty clay loam – [pyrazole-5-

14C]

22.5 (90) 20.9 (120) Silty clay loam – [thiazole-5-

14C]

22.8 (120) 22.8 (120) Clay loam – [pyrazole-5-

14C]

27.8 (90) 17.9 (120) Clay loam – [thiazole-5-

14C]

22.1 (90) 18.6 (120) Sand – [pyrazole-5-

14C]

23.8 (90) 9.4 (120) Sand – [thiazole-5-

14C]

Anaerobic Soil

14.9 (120) 14.9 (120) Sandy loam – [pyrazole-5-14C]

9.0 (90) 7.3 (120) Sandy loam – [isoxazoline-5- 49011252 14C]

Soil Photolysis

7.9 (10) 5.9 (15) Sand – [pyrazole-5-

14C]

8.9 (15) 8.9 (15) Sand – [isoxazoline-5- 49011253 14C]

Aqueous Photolysis

31.3 (15) 31.3 (15) pH 7 – [pyrazole-5-

14C]

49011122

31.6 (6) 30.3 (15) pH 7 – [thiazole-5-

14C] 

33.3 (15) 33.3 (15) natural water – [pyrazole-5-

14C]

39.3 (15) 39.3 (15) natural water – [thiazole-5-

14C] 

Anaerobic Aquatic

1.6 (100) 1.6 (100) Sand – [pyrazole-5-

14C] – Water 

1.0 (100) 1.0 (100) Sand – [pyrazole-5- 49011280 14C] – Sediment
144

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

1.6 (60) 2.5 (100) Sand – [pyrazole-5-

14C] – Total System

2.5 (100) 2.5 (100) Sand – [thiazole-5-

14C] – Water 

1.9 (100) 1.9 (100) Sand – [thiazole-5-

14C] – Sediment

4.4 (100) 4.4 (100) Sand – [thiazole-5-

14C] – Total System

2.8 (100) 2.8 (100) Silt loam – [pyrazole-5-

14C] – Water 

1.7 (100) 1.7 (100) Silt loam – [pyrazole-5-

14C] – Sediment

4.5 (100) 4.5 (100) Silt loam – [pyrazole-5-

14C] – Total System

2.0 (100) 2.0 (100) Silt loam – [thiazole-5-

14C] – Water 

1.2 (100) 1.2 (100) Silt loam – [thiazole-5-

14C] – Sediment

3.2 (100) 3.2 (100) Silt loam – [thiazole-5-

14C] – Total System

1.4 (0) 1.3 (100) Sand – [pyrazole-5-

14C] – Water 

49011281

0.7 (100) 0.7 (100) Sand – [pyrazole-5-

14C] – Sediment

2.0 (100) 2.0 (100) Sand – [pyrazole-5-

14C] – Total System

1.5 (2) 1.3 (100) Sand – [isoxazoline-5-

14C] – Water 

1.9 (60) nd Sand – [isoxazoline-5-

14C] – Sediment

3.6 (60) 1.3 (100) Sand – [isoxazoline-5-

14C] – Total System

2.4 (0) 2.0 (100) Silt loam – [pyrazole-5-

14C] – Water 

2.6 (0) 2.1 (100) Silt loam – [pyrazole-5-

14C] – Sediment

5.0 (0) 4.2 (100) Silt loam – [pyrazole-5-

14C] – Total System

2.0 (60) nd Silt loam – [isoxazoline-5-

14C] – Water 

0.14 (14) nd Silt loam – [isoxazoline-5-

14C]– Sediment

2.0 (60) nd Silt loam – [isoxazoline-5-

14C] – Total System

Un-extracted Residues

Aerobic Soil

11.2 (120) 11.2 (120) Loamy sand – [pyrazole-5-

14C] 

24.5 (90) 17.9 (120) Loamy sand – [thiazole-5- 49011250 14C] 

9.4 (90) 8.1 (134) Loamy sand – [isoxazoline-5-

14C]

9.9 (120) 9.9 (120) Loamy sand – [pyrazole-5- 49011155 14C] 

19.9 (120) 19.9 (120) Sandy loam soil – [pyrazole-5-

14C]

49011251

14.5 (120) 14.5 (120) Sandy loam – [thiazole-5-

14C] 

21.8 (120) 21.8 (120) Silty clay loam – [pyrazole-5-

14C]

42.9 (60) 38.2 (120) Silty clay loam – [thiazole-5-

14C]

34.2 (120) 34.2 (120) Clay loam – [pyrazole-5-

14C]

36.7 (90) 36.5 (120) Clay loam – [thiazole-5-

14C]

12.6 (120) 12.6 (120) Sand – [pyrazole-5-

14C]

13.2 (90) 6.7 (120) Sand – [thiazole-5-

14C]

Anaerobic Soil

5.9 (120) 5.9 (120) Sandy loam – [pyrazole-5-14C]

7.7 (30) 7.7 (30) Sandy loam – [isoxazoline-5- 49011252 14C]

Soil Photolysis

7.6 (15) 7.6 (15) Sand – [pyrazole-5-

14C]

8.1 (15) 8.1 (15) Sand – [isoxazoline-5- 49011253 14C]

Aerobic Aquatic

7.3 (99) 7.3 (99) Loamy sand – [pyrazole-5-

14C]

49011279

12.4 (60) 11.7 (99) Loamy sand – [thiazole-5-

14C]

13.5 (99) 13.5 (99) Silt loam – [pyrazole-5-

14C]

16.6 (99) 16.6 (99) Silt loam – [thiazole-5-

14C] 

Anaerobic Aquatic

5.1 (100) 5.1 (100) Sand – [pyrazole-5-

14C]

49011280

3.9 (100) 3.9 (100) Sand – [thiazole-5-

14C]

5.0 (100) 5.0 (100) Silt loam – [pyrazole-5-

14C]

5.4 (100) 5.4 (100) Silt loam – [thiazole-5-

14C]

4.2 (100) 4.2 (100) Sand – [pyrazole-5-

14C]
145

Compound

Study Type

AR% (Sampling Interval)

Maximum Final Comment MRID

Anaerobic Aquatic 3.1 (100) 3.1 (100) Sand – [isoxazoline-5-

14C]

49011281

5.0 (100) 5.0 (100) Silt loam – [pyrazole-5-

14C]

5.5 (100) 5.5 (100) Silt loam – [isoxazoline-5-

14C] 

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 components, none of which exceeded 5% at two consecutive sampling intervals, were

greater than 10% at any sampling interval, or were increasing at the end of the study.
146

Appendix 2Appendix 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 LD50 (mg/kg bw) 2250

Enter Mineau Scaling Factor 1.15

Enter Tested Bird Weight (kg) 0.178

Mammal

Enter Lowest Rat Oral LD50 (mg/kg bw) 5000

Enter Lowest Rat Inhalation LC50 (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/m3)

2.49E-04

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 3.13E-05

Adjusted Inhalation LD50 1.28E+01

Ratio of Vapor Dose to Adjusted Inhalation LD50 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 LD50

1.88E-03 Exposure not Likely Significant

Results Mammalian (0.015 kg )

Maximum Vapor Concentration in Air at 

Saturation (mg/m3)

2.49E-04

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 3.93E-05

Adjusted Inhalation LD50 3.04E+02

Ratio of Vapor Dose to Adjusted Inhalation LD50 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 LD50

9.94E-05 Exposure not Likely Significant
147

ndix 3Appendix C. Output of SIP Results

Table 1. Inputs

Parameter Value

Chemical name Oxathiapiprolin

Solubility (in water at 25oC; mg/L) 0.21

Mammalian LD50 (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 LD50 (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 aggregated 

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 4Appendix 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

(kgdiet/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

(kgdiet/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 (Dosebased EEC/LD50 or 

NOAEL)

Small mammal Medium mammal Large mammal

15 grams 35 grams 1000 grams

Acute Chronic 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

5Appendix E. Sample Ouput of KABAM Results

Characteristic Value Comments/Guidance

Pesticide Name Oxathiapiprolin Required input

Log KOW 3.6

Required input 

Enter value from acceptable or supplemental study submitted 

by registrant or available in scientific literature.

KOW 3981 No input necessary. This value is calculated automatically 

from the Log KOW value entered above.

KOC (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 (TS; days) 3 No input necessary. This value is calculated automatically from the Log KOW 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 modeled 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 days, 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 (kgdry food/kgbw/day)

Wet Food 

Ingestion 

Rate (kgwet 

food/kgbw/day)

Drinking 

Water

Intake

(L/d)

Dose 

Based 

(mg/kgbw/d)

Dietary 

Based 

(ppm)

Mammalian

fog/water shrew 0.02 0.140 0.585 0.003 0.236 0.40

rice rat/starnosed 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/kgbw)

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/starnosed 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/starnosed 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