UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

PC Codes: 028869

DP Barcode: 429606 

Date: December 2, 2015

MEMORANDUM

SUBJECT: Problem Formulation for the Ecological Risk and Drinking Water Exposure 

Assessments to be Conducted For the Registration Review of Fluoxastrobin

To: Bilin Basu, Chemical Review Manager

Jill Bloom, Team Leader

Linda Arrington, Chief

Risk Management and Implementation Branch V

Pesticide Re-evaluation Division

FROM: Rochelle F. H. Bohaty, Ph.D., Chemist 

Environmental Risk Branch 3

Environmental Fate and Effects Division (7507P)

THROUGH: Dana Spatz, Branch Chief

Environmental Risk Branch 3

Environmental Fate and Effects Division (7507P)

PEER REVIEW: Melissa Panger, Ph.D., Science Advisor

Environmental Risk Branch 2

Environmental Fate and Effects Division (7507P)

Rosanna Louie-Juzwiak, RAPL

Environmental Risk Branch 3

Environmental Fate and Effects Division (7507P)

This memo transmits the Problem Formulation for the ecological risk and drinking water 

exposure assessments to be conducted for the Registration Review for fluoxastrobin.
2

Contents

I. Executive Summary........................................................................................................................3

II. Introduction ..................................................................................................................................4

1. Previous Ecological Risk Assessments............................................................................................4

2. Drinking Water Exposure Assessments..........................................................................................5

3. Clean Water Act Programs.............................................................................................................6

III.Stressor Source and Distribution ....................................................................................................7

A. Description of Stressors .................................................................................................................7

B. Mechanism of Action .....................................................................................................................8

C. Overview of Pesticide Usage..........................................................................................................8

1. Label Uncertainties.........................................................................................................................9

A. Environmental Fate and Transport ..............................................................................................19

IV. Receptors..............................................................................................................................26

A. Ecological Incidents......................................................................................................................30

B. Exposure Pathways of Concern....................................................................................................30

V. Analysis Plan................................................................................................................................31

A. Ecological Risk Assessment ..........................................................................................................31

1. Stressors of Concern ....................................................................................................................31

2. Measures of Exposure..................................................................................................................31

3. Measure of Effects .......................................................................................................................32

4. Integration of Exposure and Effects.............................................................................................32

5. Endangered Species Assessments................................................................................................32

6. Endocrine Disruptor Screening Program......................................................................................33

B. Drinking Water.............................................................................................................................33

VI. Preliminary Identification of Data Gaps..................................................................................33

A. Environmental Fate......................................................................................................................33

B. Ecological Effects..........................................................................................................................33

VII. References (general)..............................................................................................................55

APPENDIX A. CHEMICAL IDENTIFICATION OF FLUOXASTROBIN TRANSFORMATION PRODUCTS..........56

APPENDIX B. SIP ANALYSIS RESULTS ................................................................................................58

APPENDIX C. STIR ANALYSIS RESULTS ...............................................................................................60
3

I. EXECUTIVE SUMMARY

The Environmental Fate and Effects Division (EFED) has completed the preliminary problem formulation 

(attached) for the ecological risk and drinking water exposure assessments to be conducted as part of 

the Registration Review of the strobilurin fungicide fluoxastrobin (PC 028869). This document is 

intended to provide an overview of what is currently known regarding the environmental fate and 

ecological effects associated with fluoxastrobin and its transformation products, and outlines 

uncertainties regarding attributes of these compounds. It describes the preliminary ecological risk 

hypothesis and the processes that will be used during the completion of the preliminary ecological risk 

assessment in support of Registration Review. Uncertainties unique to the risk assessment of 

fluoxastrobin are also discussed. 

A bibliography that includes the study classification for all of the studies that have been submitted to 

support the registration of fluoxastrobin is included in the data requirement table at the end of this 

document. EFED recommends requesting the following additional data to better understand the 

environmental fate and ecological effects to support the current registrations of fluoxastrobin:

• An independent laboratory validation for fluoxastrobin in water to support the environmental 

chemistry method (MRID 45865331);

As noted in previous risk assessments, fluoxastrobin has a borderline high Kow and is not expected to 

rapidly degrade via anaerobic metabolism. In addition, several fate studies have shown fluoxastrobin 

readily partitions to sediment it is observed to be persistent. Therefore, fluoxastrobin is expected to 

partition to the sediment where it may persist. Due to the toxicity of fluoxastrobin to other aquatic 

animals, benthic organisms may also be at risk and toxicity data are not available to assess such a risk. 

This is consistent with the 2011 EFED guidance.1

• Whole Sediment: Chronic Invertebrates Freshwater and Marine (OCSPP 850.1770; OCSPP

850.1760 or OECD 218): A 28-day spiked sediment study will reduce risk assessment 

uncertainties regarding freshwater and estuarine/marine sediment-dwelling organisms. 

To date, the conclusions for potential risk to honey bees are based solely on acute oral and contact 

toxicity tests for adults. The full Tier I suite of honey bee data is not available but is needed for parent 

fluoxastrobin (TGAI, unless otherwise noted below). Based on the new guidance2 for assessing risk to 

bees the following studies are needed:

• Honey Bee Larvae Acute Oral Study (Non-guideline / OECD TG237, Tier 1). 

• Honey Bee Larvae Chronic Oral Toxicity Study (Non-guideline, Tier 1).

• Honey Bee Adult Chronic Oral Toxicity Study (Non-guideline, Tier 1).

• Semi-field Testing for Pollinators Using TEP (Non-guideline / OECD 75, Tier 2)

• Field Trial of Residues in Pollen and Nectar using TEP (Non-guideline, Tier 2)

• Field Testing for Pollinators Using TEP (OCSPP 850.3040, Tier 3)

 1 U.S. EPA OCSPP Series 850 Guideline Numbers to Reference when Requesting a Whole Sediment Chronic Toxicity 

Test, January 20, 2011

2 U.S. EPA Guidance and Implementation of Exposure and Effects Testing for Assessing Risks to Bees, March 18, 

2014
4

II. INTRODUCTION

Conclusions of the previous assessments are summarized in Table II.1 and additional details are 

provided in the subsections below.

Table II.1. Summary of Previous Risk Concernsa Identified for Fluoxastrobin

Exposure 

Basis Birds Mammals Terrestrial Plants

Terr. 

Inverts. 

(honey 

bee 

hazard)

Fish Aquatic 

Inverts

Aquatic 

Plants Mobile Persistence Degradates of Concern

Acute Nob No

No No

Yes Yes

No Yesc Yes None

Chronic Yes Yes No Yes

a. At least one LOC has been exceeded in previous assessments

b. Uncertain due to lack of data (e.g., passerine data not used at time of risk assessment); however, data on other avian 

species suggest the likelihood of effect is limited. 

c. slightly to moderately mobile

1. Previous Ecological Risk Assessments

Seven ecological risk assessments have been completed for the registration of fluoxastrobin for use on 

agricultural crops and non-cropped areas. Uses assessed include peanut, potato and tuber vegetables, 

leaf petioles subgroup, fruiting vegetables, turf, and seed treatments for potato, peanut and turf 

(D028869), field and seed corn, low-growing berries, soybean, sweet corn and wheat (D356983, 

D357729, D366187), squash/cucumber and in-furrow and banded uses on tuberous and corm 

vegetables as well as peanut (D379112, D384375), melon and sorghum (D403574), rice (D392988).

Several of the assessment are abbreviated drawing conclusions based on similar use patterns previously 

assessed. Conclusions of the previous assessments are summarized in Table II.2. The only residue of 

concern evaluated in these assessment is fluoxastrobin. Based on available data for a variety of taxa, 

fluoxastrobin is expected to be considerably more toxic to non-target species than its environmental 

transformation products.

Table II.2. Summary of Previous Risk Assessments Conducted on Fluoxastrobin

Use

Reference/ 

Year 

Completed

Maximum 

Application Rate 

Assessed (lb a.i./A)

Conclusions

Peanut, potato, 

tuber vegetables, 

leaf petioles, 

fruiting 

vegetables, turf 

and seed 

treatments for 

potato, peanut, 

and turf

D028869

July 29, 

2004

Revised 

D312237

February 

10, 2005

0.55 (single 

application)

2.2 (yearly 

application)

Risk was identified for estuarine/marine 

invertebrates, mollusk, listed freshwater fish, and

freshwater invertebrates.

Low-growing 

berries, soybean, 

Risk was identified for estuarine/marine 

invertebrates, mollusk, listed freshwater fish, listed 
5

field and seed 

corn

D356983, 

D357729, 

D366187

July 17, 

2009

0.18 (single 

application)

0.72 (per year)

freshwater invertebrates, birds and mammals. 

However, no risk was identified to terrestrial plants 

estuarine/marine fish and aquatic plants.

Sweet corn and 

wheat

Squash/Cucumber 

and In-furrow and 

banded uses on 

tuberous and 

corm vegetables 

and peanut

D379112, 

D384375

January 10, 

2011

0.18 (single 

application)

0.72 (per year)

Ornamental

D349270, 

D349282

August 29, 

2008

0.55 (single 

application)

2.2 (yearly 

application)

Risks identified are the same as those previously 

identified for the same as previously identified for the 

same application rate. 

Rice

D392988

May 8, 

2012

0.18 (single 

application)

0.36 (per year)

Risk was identified for freshwater fish, freshwater 

invertebrates, estuarine/marine invertebrates, listed 

non-vascular aquatic plants. However, risk to 

terrestrial organisms (animals and plants) 

estuarine/marine fish, and vascular aquatic plants 

were not identified. 

Melon and 

sorghum

D403574

March 19, 

2013

Risks for use on melon (0.18 lb a.i./A single application; 0.72 lb a.i./A per 

year) are the same as those previously identified for cucurbits. Risks for use 

on sorghum (0.12 lb a.i./A; 0.24 lb a.i./A) are the same as those identified

for wheat. 

Field Corn (seed 

treatment)

D415725, 

D417151, 

D417733

No level of concern (LOC) exceedances for seed treatment; Risks identified 

are the same as those previously identified for the same annual application 

rate of 0.36 lb a.i./A.

2. Drinking Water Exposure Assessments

Several drinking water assessments (DWA) have been completed for fluoxastrobin including for use on 

peanut, potato and tuber vegetables, leaf petioles subgroup, fruiting vegetables, turf; and seed 

treatments for potato, peanut, and turf (D289104), field and seed corn, low-growing berries, and 

soybean (D356984, D357669), sweet corn and wheat (D366189), Squash/Cucumber (crop subgroup 9B) 

and New In-Furrow and Banded Uses on Tuberous and Corm Vegetables (crop subgroup 1C) as well as 

Peanut (D379114, D384377), melon and sorghum (D403757), rice (D401613, D392990). The only residue 

of concern considered in these drinking water assessments is fluoxastrobin. The highest estimated 

drinking water concentrations (EDWCs) are residues in groundwater resulting from turf applications. 

Table II.3. Summary of Previous Drinking Water Assessments

Use

Reference

/ Year 

Completed

Models 

Used

Estimated Surface Water 

Concentrations (μg/L)a

Estimated Groundwater 

Concentrationsb

(μg/L)

1-in-10 

year Peak

1-in-10 year 

Annual Mean

30 Year 

Mean Peak

Post 

Breakthrough 

Average

Peanut, potato, 

tuber D289104a FIRST, SCIGROW 71 28 <1 μg/L
6

vegetables, leaf 

petioles, fruiting 

vegetables, turf 

and seed 

treatments for 

potato, peanut, 

and turf

November 

23, 2004

Low-growing 

berries,

soybean, field 

and seed corn

D356984, 

D357669

June 18, 

2009

PRZMEXAMS, 

SCI-GROW

23.7 17.0 11.9

Sweet corn and 

wheat D366189b

PRZMEXAMS, 

SCI-GROW

38 30 14

Squash/Cucumb

er and In-furrow 

and banded 

uses on 

tuberous and 

corm vegetables 

and peanut

D379114, 

D384377c

PRZMEXAMS, 

SCI-GROW

61 53 24

Rice D392990, 

D401613 Tier 1 Rice 93 0.038 0.23

Melon and 

sorghum D403757d

PRZMEXAMS, 

PRZM-GW

49 19 12

146 137

Field Corn (seed 

treatment)

D415725, 

D417151, 

D417733

PRZM-GW Not referenced

a. Estimations based on turf use (4 x 0.55 lbs ai/A @ 21 day interval, ground application)

b. Estimations based on turf use (4 x 0.55 lbs ai/A @ 14 day interval, ground application)

c. Updated turf EDWCs reflect new input parameter guidance

d. Estimations based on turf use (4 x 0.55 lbs ai/A @7 day interval, ground application)

3. Clean Water Act Programs 

Fluoxastrobin has not been identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.3 No Total Maximum Daily Load (TMDL) criteria have been 

developed.

4 The EPA invites submission of water quality data for this pesticide. To the extent possible, 

data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: 

Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk 

Assessment and Management Process5 in order to ensure the data can be used quantitatively or

qualitatively in pesticide risk assessments.

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

4

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_polluta

nt_group_name=PESTICIDES

5 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
7

Aquatic benchmarks have not been established for fluoxastrobin.

6 Any data submitted or otherwise 

located as part of the registration review process may be used to establish aquatic life benchmarks if 

applicable.

III. STRESSOR SOURCE AND DISTRIBUTION

A. Description of Stressors

The chemical structure of fluoxastrobin along with the chemical identification and select physicalchemical properties are provided in Table III.5. In addition to the technical grade products [fluoxastrobin

(264-1137 and 66330-65), there are nine fluoxastrobin registered end-use products (264-1169, 66330-

64, 66330-379, 66330-380 and 66330-383, 66330-388, 66330-407, 66330-409, 66330-424. Of the nine 

end-use products five contain other active ingredients (Table III.2). Environmental transformation 

products of fluoxastrobin include HEC 5725-oxazepine, HEC 5725-phenoxy-amino-pyrimidine, HEC 5725-

E-des-chlorophenyl (HEC 7155), HEC 5725-4-hydroxyphenyl and HEC 5725-amide (HEC 7338.), EC 5725-

des-chlorophenyl carboxylic acid (HEC 7334), and HEC 5725-carboxylic acid (HEC 7180). Additional 

information on these transformation products is included in the Environmental Fate Section of this 

document as well as in Appendix B. The only residue of concern is fluoxastrobin.

Table III.1. Chemical Identification and Physical Chemical Properties of Fluoxastrobin

Common Chemical Name Fluoxastrobin

Company Code HEC5725

Chemical Name [(1E)-[2-[[6-(2-Chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl] 5,6-dihydro1,4,2-dioxazin-3-yl) methanone-O-methyloxime]

CAS Registry Number 361377-29-9 [E-isomer] 

Chemical Structure

O

N N

O N

O

O N

Cl F

O

CH3

Molecular Formula C21H16ClFN4O5

SMILES NOTATION C1=NC(=C(C(=N1)OC2=C(C=CC=C2)Cl)F)OC3=C(C=CC=C3)\C(=N/OC)C4=NOCCO4

Molecular Mass (g/mol) 458.83

Vapor Pressure (25 °C) 4.23 x 10-12 torr (5.63 x 10-10 Pa at 20 and 8.72 x 10-10 Pa at 25)

Water Solubility (mg/L; 

20 °C)

pH 4: 2.431 

pH 7: 2.292

pH 9: 2.292 

unbuffered: 2.559

Henry’s Law Constant 1.01 x 10-7 Pa m3 / mole (9.98 atm - m3/mol)

Log Kow (20 °C) 2.86

pKa -2.1 (estimated)

Most data were obtained from product chemistry submitted for technical fluoxastrobin submission (MRID 

45865303)

 6 http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm; http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/aquatic-life-benchmarks-pesticide-registration
8

Table III.2. Multiple Active Ingredient Formulations of Fluoxastrobin

Formulation

Reg. No.

Percent (%) 

Fluoxastrobin in 

Formulated End-Use 

Product

Other Active 

Ingredient; Percent (%) 

in Formulated End-Use 

Product

66330-379 2.44 Chlorothalonil;

38.4

66330-383 18 Tebuconazole;

25

66330-388 18 Myclobutanil;

25.6

66330-407 14.84 Flutriafol;

19.3

66330-424 17.76 Tetraconazole;

17.76

B. Mechanism of Action

Fluoxastrobin is a “leaf-systemic” strobilurin fungicide. Strobilurin fungicides (QoI family) are site-specific 

compounds that provide significant control of plant diseases caused by pathogens. These compounds 

work by interfering with respiration in plant-pathogenic fungi. This is done by binding the Qo-centre on 

cytochrome b blocking electron transfer between cytochrome b and cytochrome c1. This disrupts the 

energy cycle within the fungus by halting the production of ATP. Strobilurin fungicides also have 

translaminar activity, therefore, enabling movement through treated leaves providing control on leaf 

surfaces. Fluoxastrobin is also shown to be effective in inhibiting spore germination and mycelial 

growth.

C. Overview of Pesticide Usage

Fluoxastrobin was first registered in the United States on September 20, 2005. It is currently registered 

for use on berries, corn, fruiting vegetables, leafy vegetables, melons, ornamentals, peanuts, potato,

rice, sorghum, soybeans, squash/cucumber, tuber/corm vegetables, turf (commercial/institutional 

lawns, golf course, ornamental, sod farms, residential lawns), and wheat. 

Most products are formulated as a flowable, emulsifiable or soluble concentrate; however, there is one 

granular product (Reg. 66330-380) and one water dispersible granule product (Reg. No. 66330-407). 

Application types include seed treatment, broadcast (aerial and ground), chemigation, ground band 

treatment, drench and in-furrow.

Based on current labels, the maximum single application rate ranges from 0.006 to 2.0 pounds of active 

ingredient per acre (lb a.i./acre). Up to four applications per year is allowed for some uses; however, it 

should be noted that for several uses the number of applications per year is not specified. A complete 

list of all current fluoxastrobin uses and how EFED currently understands the uses is presented in Table 

III.3. This table was developed based on the label data information provided to EFED by Biological 

Economic Analysis Division (BEAD).
9

Based on the BEAD chemical profile for Registration Review7

, between 2008 -2013, 33,000 pounds of 

active ingredient were applied on average annually to 363,000 acres. According to the BEAD Screening 

Level Usage Analysis (SLUA) 8

, between 2004-2013, the average percent crop treated (PCT) for all crops 

(corn, peanuts, peppers, potatoes, soybean, and wheat) screened <2.5%. The highest average annual 

pounds a.i. applied was 10,000 lb active ingredient to corn, soybeans, and wheat. 

Approximately 20,000 lbs active ingredient of fluoxastrobin was reportedly used in the professional turf 

management and horticultural and horticultural segments.

1. Label Uncertainties

For some terrestrial uses, the number of applications of fluoxastrobin that can be applied per calendar 

year or the maximum annual application rate for a given use is not explicitly stated on many of the 

current labels. See Table III.3 for specifics. Assumptions that will be made in absence of label 

clarifications are provided in brackets in the aforementioned table.

 7 Yourman, L., Doucoure, C. Berwald, D. BEAD Chemical Profile for Registration Review: Fluoxastrobin (028869) 

May 13, 2015

8 Yourman, Leonard, Doucoure, C., Berwald, D., Fluoxastrobin Label Use Report Package in Support of Registration 

Review, June 10, 2015
10

Table III.3. Fluoxastrobin Label Summary Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

Low growing berry 

subgroup (13-07G)

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation

0.1777 0.7107 NS NS

[4] NS 1 14 New Yorkc Reg. No. 66330-64

At planting; in 

furrow

Tuberous and corm 

vegetables subgroup (1C)

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation

0.1216 0.7107 NS NS

[6] NS 7 7 New Yorkc Reg. No. 66330-64

At planting; in 

furrow

Leaf petioles subgroup (4B)

Foliar; 

broadcast 

(ground), 

chemigation

0.1777 0.7107 0.7107 NS

[4] 4 7 New Yorkc Reg. No. 66330-64

Melon subgroup (9A)

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation

0.1777 0.7107 0.7107 NS

[4] 4 1 7 New Yorkc Reg. No. 66330-64
11

Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

At planting; in 

furrow

Squash/Cucumber subgroup 

(9B)

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation 0.1777 0.7107 0.7107 NS

[4] 4 1 7 New Yorkc Reg. No. 66330-64

At planting; in 

furrow

COMMERCIAL/INDUSTRIAL 

LAWNS

Foliar; 

broadcast 

(ground), 

chemigation

0.7189 NS

[1.6542] 1.6542 NS

[3]

NS

[3] NA 14 Reg. No. 66330-379

CORN (ALL OR 

UNSPECIFIED)

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation 0.1777 0.7107 0.7107 NS

[4] 4 30 7 New Yorkc Reg. No. 66330-64

At planting; in 

furrow
12

Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

CORN, FIELD

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation 0.1777 0.3553 NS

[0.3553]

NS

[2] 2 36 7 New Yorkc Reg. No. 66330-64, 66330-383

At planting; in 

furrow

Seed 

Treatment

0.0006 lb/lb 

seed 0.36 0.36 NS

[3]d

NS

[3]d NS NS None 264-1169

CORN, SWEET

Foliar; 

broadcast 

(aerial), 

chemigation

0.1184

0.4738 NS

[0.4738]

NS

[4] 4

See 

footnote 

h

14

New Yorkc Foliar; banded Reg. No. 66330-64 

(ground)

0.1777

At planting; in 

furrow

Foliar; 

broadcast 

(aerial and 

ground)

0.1172 0.4688 0.2344 NS

[4] 2 None Reg. No. 66330-383
13

Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

FRUITING VEGETABLES

Foliar; 

broadcast 

(ground), 

chemigation

0.1777 0.7107 NS

[0.7107]

NS

[4] 4 3 7 New Yorkc Reg. No. 66330-64

GOLF COURSE TURF

Foliar; 

broadcast 

(ground), 

chemigation

0.4644 NS

[1.6542] 1.6542 NS

[4] NA

NS

7 None Reg. No. 66330-379

Foliar; 

broadcast 

(ground)

0.5079 2.1161 NS

[2.1161] 4 NA 21 New York Reg. No.

66330-383

0.509 NS

[2.2395] 2.2395 NS

[1] NA 14 None

Reg. No.

66330-379; do not make more 

than 2 applications at a rate 

greater than 14.6 pt/a per 

growing season

ORNAMENTAL LAWNS AND 

TURF

When needed; 

broadcast 

(ground)

0.4987 2.132 NS

[2.0]

NS

[5]

4 NS

7 New Yorkc Reg. No. 66330-64

0.5067 2.1804 NS

[2.0]

NS

[5] NS Californiae Reg. No. 66330-388

0.5 2.2 NS

[2.0]

NS

[5] 4 7 California Granular

Reg. No. 66330-380
14

Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

When needed; 

broadcast 

(ground)

1.19 NS

[1.19] 4 NS

[4] 14 Nonef Reg. No. 66330-407

ORNAMENTAL SOD FARM 

(TURF)

Foliar; 

broadcast 

(ground)

0.8271 NS

[1.65] 0.8271 NS

[2]

NS

[2]

NS

14 Residential 

lawns Reg. No. 66330-379

When needed; 

broadcast 

(ground)

0.5 2.2 NS

[2.0]

NS

[5]

4

7 California Granular

Reg. No. 66330-380

0.5067 2.1804 NS

[2.0]

NS

[5] NS Californiae Reg. No. 66330-388

ORNAMENTALS 

(UNSPECIFIED)

Foliar; 

broadcast 

(ground),

chemigation

0.1255 0.8087 NS

[0.8087] 4

NA NS

14 New Yorkc Reg. No. 66330-388

0.9968 2.132 NS

[2.132] 4 7 New Yorkc Reg. No. 66330-64Label error reportedg

0.1281 lb/ 100 

gal 1.23 NS

[1.23]

NS

[1] 7 New Yorkc Reg. No. 66330-388

0.1247 2.132 NS

[2.132]

NS

[17]

NS

[17] 7 Reg. No. 66330-64

Label error reportedg
15

Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

When needed; 

soil drench, 

soil treatment

(ground)

2 2.132 NS

[2.132]

NS

[2]

NS

[2] 14

Pre-plant, Soil 

mix 

0.0001 lb/cu ft

[0.55] 2.2 NS

[2.2]

NS

[4] 4 28 Reg. No. 66330-380

PEANUTS (UNSPECIFIED)

Foliar; 

broadcast 

(aerial)

0.1458 0.5834 NS

[0.5834]

NS

[4] 4 14 14 None Reg. Nos. 66330-383, 66330-64 Foliar; banded 

(ground)

0.1777 0.7107 NS

[0.7107] At planting; in 

furrow

POTATO, WHITE/IRISH (OR 

UNSPECIFIED)

Foliar; banded 

(ground)

0.1216 0.7107 NS

[0.7107]

NS

[6] 6 7 7

Only 

allowed in 

Idaho

Reg. No. ID080006

At planting; in 

furrow

RESIDENTIAL LAWNS

When needed; 

broadcast 

(ground)

0.4 1.19 NA 4 NA NS 14 None Reg. No. 66330-407
16

Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

RICE

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation

0.1777 0.3553 NS

[0.3553]

NS

[2] 2 28 27 New Yorkc

California Reg. No. 66330-64

SORGHUM (UNSPECIFIED)

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation 0.1247

0.2494 NS

[0.2494]

NS

[2] 2 14 14 New Yorkc

California Reg. No. 66330-64

At planting; in 

furrow

Foliar; banded 

(ground)

0.1309
17

Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

SOYBEANS (UNSPECIFIED)

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation

0.1777 0.3553 NS

[0.3553]

NS

[2] 2 30 14 New Yorkc

California

Reg. Nos. 66330-383, 66330-64, 

66330-409

Foliar; banded 

(ground)

At planting; in 

furrow Reg. No. 66330-64

WHEAT

Foliar; 

broadcast 

(aerial and 

ground), 

chemigation

0.1247 0.2494 NS

[0.2494]

NS

[2] 2

See 

footnote 

i

14 New Yorkc

California

Reg. No. 66330-64; lower 

applications permitted with 

shorter MRIs (0.0781 lb a.i./A has 

7 days MRI)

a. Reported as per crop cycle or per season

b. PHI – Preharvest Interval; MRI – Minimum Retreatment Interval

c. In New York State, this product may not be applied within 100 feet of a coastal marsh or stream that drains directly into a coastal marsh; Sale, use, and distribution of 

this product in Nassau and Suffolk Counties of New York State is prohibited.

d. Assumes seed treatment and foliar applications can occur for a single crop.

e. Not for use in California to control Rhizoctonia Sheath Spot (Rhizoctonia zea I Waitea circinata varzeae); Not for homeowner use. May only be applied to residential turf 

by a certified pest control operator

f. Non-residential turf "

g. Label error: The soil rates are less than the max yearly rate and the broadcast/chemigation exceeds the max yearly rate. Intended use needs to be clarified.
18

Crop/Site

Timing;

Application 

Type; 

Method/

Equipment

Maximum 

Single 

Application 

Rate by 

Formulation

Maximum 

Application Rate

Maximum 

Application 

Number 

PHI (days)bMRI (days)bGeographic Restrictions

Comments

(lb/A) Per Year

lb/A

Per CCa

lb/A

Per 

Year

Per 

CCa

h. 49 day(s) preharvest interval (fodder).,7 day(s) preharvest interval (forage) at higher application rates; 7 day(s) preharvest interval (forage, fodder).,23 (days) preharvest 

interval (stover) at lower application rates

i. 40 day(s) preharvest interval (fodder).,7 day(s) preharvest interval (forage).,40 day(s) preharvest interval (grain).,7 day(s) preharvest interval (dry hay).
19

A. Environmental Fate and Transport

Based on physicochemical properties (Table III.1) alone, volatility is not expected to be a major 

dissipation pathway for fluoxastrobin, and fluoxastrobin is not expected to bioconcentrate. In summary, 

based on laboratory studies, fluoxastrobin persists in soils for several months to more than a year, and is 

slightly to moderately mobile in soils. As for aquatic environments, fluoxastrobin has been shown to be 

stable to hydrolysis. Fluoxastrobin is slightly susceptible to microbial degradation in aquatic 

environments. Environmental fate parameters of fluoxastrobin are presented in Table III.5 and 

summarized below.

Fluoxastrobin is stable in sterile solutions at pH 4, 7, and 9 at 50 °C (MRID 45865304). Aqueous 

photolysis of fluoxastrobin has been shown to be a major route of fluoxastrobin (chlorophenyl labeled 

ring 98:2 E:Z isomer ratio) transformation in sterile water (MRIDs 45865306, 45865403). The 

concentration of the z-isomer increased upon radiation reaching an E:Z isomer ratio of approximately 

7:1 during the study. One major transformation product (HEC 5725-oxazepine; 23.6% of maximum 

concentration of applied) and one minor (HEC 5725-phenoxy-amino-pyrimidine; 4.7% maximum 

concentration of applied) was observed. An additional photolysis study performed in natural 

water/sediment systems (MRID 45865327) indicates that the majority of applied fluoxastrobin adsorbs 

to sediment and no transformation occurs under pseudo environmental conditions. Thus, the 

dissipation of fluoxastrobin in water is expected to depend on physical characteristics of the water (e.g., 

sediment loading, depth, etc.) which have an effect on sunlight penetration as well as the rate of 

fluoxastrobin sediment partitioning.

Aerobic soil metabolism half-life values for extracted residues 15.3 to 540 days in four soils (MRID 

45865309, 45865310). Both of these studies have been reclassified to supplemental as there is 

approximately 20 to 70% unextracted residues depending on the test soil. Examination of the suite of 

studies indicates that as the amount of unextracted residues increase the half-life value decreases. 

Given the wide range in calculated half-life values and the large amount of unextracted residues 

fluoxastrobin is thought to be persistent. Major transformation products observed in these studies 

include HEC 7155 and carbon dioxide. Minor transformation products include HEC 5725-4-

hydroxyphenyl and HEC 7338.

Aerobic aquatic metabolism total system (sediment and water) half-life values for fluoxastrobin are 227 

and 390 days (MRID 45865313). HEC 7155 is the only major transformation product observed with a 

maximum observed concentration of approximately 20%; however, several minor transformation 

products were observed including HEC 7334, HEC 7180 and HEC 7338. In anaerobic environments, 

fluoxastrobin degraded with total system half-life value of 310 days (MRID 45865312). In anaerobic 

aquatic environments, the major transformation product observed was HEC 7180 with a maximum 

observed concentration of approximately 20%. The only minor transformation product identified was 

HEC 7338. Fluoxastrobin was observed to partition to sediment under aerobic and anaerobic aquatic 

conditions. 

Based upon batch equilibrium data (Koc 424 – 1580; MRID 45865315) fluoxastrobin is considered mobile 

to moderately mobile based on FAO mobility classification9

. None of the test soils had an organic matter 

content ≤1%. Fluoxastrobin transformation products, HEC 7155 and HEC 7334, are both more mobile 

 9 USEPA, 2006. Standardized Soil Mobility Classification Guidance. Memorandum: S. Bradbury, April 21, 2006.
20

than fluoxastrobin (Koc 14 – 181.5; MRID 45865314, Koc 37 – 87; MRID 45865316, respectively). 

Adsorption and desorption constants are provided in Table III.4. High performance liquid 

chromatography was used to estimate adsorption coefficients (Koc) for HEC5725-amide, HEC5725-

hydroxyphenyl, and HEC5725-carboxylic acid (MRID 45865401). The values (estimated 505, 319, and 39, 

respectively) suggest these transformation products are generally more mobile than fluoxastrobin. 

Table III.4. Adsorption and Desorption Constants

Soil

Adsorption Desorption

K 1/N R2 Koc K 1/N R2 Koc

Fluoxastrobin; MRID 45865315, acceptable

Laacher Hof AXXa sandy loam 12.70 0.8356 0.9886 628.8 20.33 0.8781 0.9995 1006.3

Höfchen am Hohenseh 4a silt 16.21 0.8738 0.9946 757.6 23.30 0.8922 0.9999 1088.7

Stanley silty clay loam 26.26 0.8749 0.9969 1582.1 23.91 0.8645 1.0000 1440.4

Byromville loamy sand 3.35 0.8493 0.9994 424.3 5.09 0.8666 0.9982 644.6

HEC 5725-E-des-chlorophenyl (HEC 7155); MRID 45865314, acceptable

Laacher Hof AXXa sandy loam 0.28 0.94 1.0000 14.0 1.36 0.97 0.9995 67.3

Höfchen am Hohenseh 4a silt 0.47 0.95 0.9999 22.1 1.29 0.98 0.9997 60.3

Stanley silty clay loam 3.01 0.98 0.9999 181.5 3.01 0.97 0.9999 181.5

Byromville loamy sand 0.18 0.92 0.9999 23.4 1.29 0.99 0.9994 163.0

HEC 5725-des-chlorophenyl carboxylic acid (HEC 7334); MRID 45865316, acceptable

BBA 2.2 loamy sand 1.12 0.9590 0.9999 56 3.46 0.9560 0.9985 174

Laacher Hof AXXa sandy loam 0.58 0.8610 0.9989 56 2.49 0.8449 0.9987 244

Boden LUFA Speyer sandy loam 0.50 0.8993 0.9998 37 2.69 0.9366 0.9971 196

Stanley silty clay 1.41 0.8979 0.9994 87 5.21 0.9467 0.9993 322

K - Freundlich adsorption and desorption coefficients (L/Kg- soil); 1/N -Slope of Freundlich 

adsorption/desorption isotherms; Koc - Coefficient adsorption per organic carbon (L/kg OC); R2 - Regression 

coefficient of Freundlich equation. 

Terrestrial field dissipation studies indicate that fluoxastrobin persists for over a year. However, it was 

not observed to leach through soil. Out of the three major metabolites mentioned above, only HEC 7155 

was detected in the terrestrial field studies. The observed concentration of HEC 7155 is below 10% of 

the total applied. This metabolite is also observed in the deeper soil layers, but at less than 1% of the 

total applied. A recently submitted aquatic field dissipation study conducted on rice has several 

deficiencies; however, the study suggests fluoxastrobin readily dissipates from the water column but 

may persist in sediment. The rapid dissipation of fluoxastrobin from the water column is due to 

partitioning to sediment; however, the role of transformation was not investigated. The route of 

fluoxastrobin dissipation under aquatic field conditions could not be determined as soil and water 

samples were not analyzed for transformation products. The total system (water and soil/sediment) 

half-life as well as residual residues indicate fluoxastrobin persists beyond the study duration. This 

suggests that accumulation (carry over) of fluoxastrobin in rice paddies is possible. The mobility of 
21

fluoxastrobin in the soil profile could not be assessed based on the data included in this study. These 

results are consistent with laboratory studies.

The storage stability study (MRID 46569701) indicates fluoxastrobin and relevant transformation 

products are stable up to 37-38 months in soils. No acceptable storage stability data are available for 

fluoxastrobin in aquatic systems. It should be noted that an aquatic field dissipation study was 

submitted as part of the request to register fluoxastrobin for use on rice. This study was classified as 

upgradable because storage stability data were not provided with the submission.

The environmental chemistry method for soil reports the limit of quantification (LOQ) of fluoxastrobin 

(E/Z isomers), HEC 5725-E-des-chlorophenyl and HEC 5725-E/Z-carboxylic acid as 5 μg/kg (0.01 lb/A)

10

with a limit of detection of 2 μg/kg (MRID 45865328)]. An environmental chemistry method for water 

reports a LOQ for HEC 5725 0.05 μg/L (0.000005 lb a.i./A; MRID 45865331). An independent laboratory 

validation is not available for the water method. Based on toxicity information presented in Table IV.1

and Table IV.2 these methods are adequate for detecting fluoxastrobin at concentrations that are below 

the level of concern for all taxa that data are available. 

Maximum bioconcentration factor (BCF) for fluoxastrobin residues was 19.5-26.2 for the edible tissues,

119.1-131.1 for the nonedible tissues, and 61.6-66.9 for the whole fish (MRID 458654-21). The steady 

state bioconcentration factor (BCF) ranged from 13.3-18.2 for both isomers in whole fish tissue.

Depuration occurred rapidly with approximately 80% of the residues eliminated one day after exposure 

ceased. Approximately 95% of the residues were eliminated after 14 days of no exposure. The E-isomer 

was favored with an approximate ratio of 13:1 at 7 days and 10:1 at 14 days. Three transformation 

products were identified: HEC5725-E-des-chlorophenyl and HEC5725-di-OH-diene.

 10 LOQ = 0.005 mg/kg (LOD = 0.002 mg/kg)

0.005 mg/kg (s) = [x] kg/ha x 106 mg/kg / [0.15 m (depth) x 104 m2

/ha x 1.5 x 103 kg(s)/m3(density)]

0.005 mg/kg(s) = [x] kg/ha x 106 mg/kg / 2.25 x 106 kg (s)/ha

= 1.1 x 10-2 kg/ha = LOQ = 0.01 lb a.i./A
22

Table III.5. Environmental Fate Parameters of Fluoxastrobin

Study/ 

Guideline

System Name/ 

Characteristics

Kinetic Model Fitteda Value 

and Unit (Fitting Equation)

Representative Half-life 

Value

--Value Used to Derive 

Model Input Values 

(days)b--

Source/ 

Classification

Comments

DT50 (days) DT90 (days)

Hydrolysis

835.2010

pH 4, 50  ̊C

stable 0

MRID

45865304

acceptable

pH 7, 50  ̊C

pH 9, 50  ̊C

Aqueous 

Photolysis

835.2240

0.02 M phosphate, pH 7 adjusted: 8.2 

(4.1)

MRIDs

45865306, 

45865403 

acceptable

Adjusted value reflects 12-h light/12-h dark 

cycle; 1 hours of irradiation were reported to 

be equivalent to 4.9 days in June in Phoenix, 

Arizona (33.26  ̊N); 1 hour or irradiation were 

reported to be equivalent to 6.9 days in june in 

Edmonton, Alberta, Canada (53.33  ̊N). 

Representative half-life value reflects 

adjustment to 40  ̊N.

Pond (Hönniger Weiher) pH 

5.8 (sediment, CaCl2), 6.7 

(H20), 4.80% OC, 25  ̊C MRID

458365327

supplemental

Previously reported values 51 days

Lake (Angler Weiher)

pH 7.4 (sediment, CaCl2),pH 

7.2 (H2O) 1.37% OC, 25  ̊C

Previously reported value 39 days

Soil Photolysis

835.2410

Loamy sand, pH 6.1; 0.79% 

OC, 20  ̊C stable 0

MRID 

45865308

acceptable

Aerobic Soil 

Metabolism

835.4100

Sandy loam (Monheim, 

Germany; Laacher Hof 

AXXa), pH 6.4-7.0, 1.8% OC, 

3.1% OM

18.5

(IORE)

74.8

(IORE)

TR = 22.5

(IORE)

MRID

45865309

Reclassified as 

supplemental

Methoxyiminotolyl-ring labeled study; 

Previously reported half-life value was 29.4 

days. The presented half-life value only 

represents extracted residues. The soil 

extraction methods utilized in this study are not 

considered exhaustive and an increasing 

amount of non-extracted residues were 

observed (70.6% at 120 DAT).

Silt (Burscheid, Germany; 

Hoefchen Am Hohenseh 

11.2

(IORE)

50.7

(IORE)

TR = 15.3

(IORE)

MRID

45865310

Previously reported half-life value was 26.2 and 

30.1 days. The presented half-life value 

represents extracted residues of both 
23

Study/ 

Guideline

System Name/ 

Characteristics

Kinetic Model Fitteda Value 

and Unit (Fitting Equation)

Representative Half-life 

Value

--Value Used to Derive 

Model Input Values 

(days)b--

Source/ 

Classification

Comments

DT50 (days) DT90 (days)

4A) pH 7.8 (H2O), 2.6% OC, 

4.5% OM

Reclassified as 

supplemental

radiolabeled compounds. The soil extraction 

methods utilized in this study are not 

considered exhaustive and an increasing 

amount of non-extracted residues were 

observed (Pyrimidine-labeled study: 35.2% at 

120 DAT and Methoxyiminotolyl-ring: 57.8% at 

120 DAT). Neither radiolabeled experiment had 

replicates.

Silt loam (Monheim, 

Germany; Laacherhof A II) 

pH 8.1 (H2O), 0.86% OC, 

1.48% OM

47.1

(SFO)

156

(SFO)

t1⁄2 = 47.1

(SFO)

Methoxyiminotolyl-ring labeled study; 

Previously reported half-life value was 46.6 

days. The presented half-life value only 

represents extracted residues. The soil 

extraction methods utilized in this study are not 

considered exhaustive and an increasing 

amount of non-extracted residues were 

observed (38.7% at 120 DAT).

Loamy sand (Georgia, USA); 

Byromville) pH 6.1, - % OC, 

0.43% OM

331

(DFOP)

1585

(DFOP)

t1⁄2 slow = 540

(DFOP)

Previously reported half-life value were 323 and 

393 days for fluoxastrobin labeled in two 

different locations. The presented half-life 

value represents extracted residues of both 

radiolabeled compounds. The soil extraction 

methods utilized in this study are not 

considered exhaustive and an increasing 

amount of non-extracted residues were 

observed (Pyrimidine-labeled study: 22.6% at 

DAT 270 and Methoxyiminotolyl-ring labeled 

study: 23.4% at 365 DAT). Neither radiolabeled 

experiment had replicates. 

Anaerobic Soil 

Metabolism

835.4200

No data
24

Study/ 

Guideline

System Name/ 

Characteristics

Kinetic Model Fitteda Value 

and Unit (Fitting Equation)

Representative Half-life 

Value

--Value Used to Derive 

Model Input Values 

(days)b--

Source/ 

Classification

Comments

DT50 (days) DT90 (days)

Aerobic 

Aquatic

Metabolism

835.4300

Loam (Wipperfürth, 

Germany; Hӧnnlger) pH 6.6 

(H2O), 4.8% OC, 8.28% OM

263 1168 t1⁄2 slow = 390

(DFOP)

MRIDs 

45865313, 

46925806

acceptable

Previously reported half-life values were 150 

and 190 days for fluoxastrobin in the two 

different test systems. The registrant 

responded (MRID 46925806) to the deficiencies 

in the data evaluation report and the 

acceptability of the aerobic aquatic study 

submitted in support of the fluoxastrobin 

registration (MRID 45865313). The study was 

reevaluated and determined to be acceptable 

as EFED does not expect fluoxastrobin to sorb 

to the glass test apparatus to a sufficient 

degree to affect the study results, as 

demonstrated by the material balance. 

Unextracted residues were observed at 

concentrations up to 12% at 122 DAT.

Loamy sand (Leverkusen, 

Germany; Anglerweiher) pH 

8.5, 1.37% OC, 2.36% OM

164

(DFOP)

691

(DFOP)

t1⁄2 slow = 227

(DFOP)

Anaerobic 

Aquatic

Metabolism

834.4400

Sandy loam/loamy sand 

(Georgia, USA; Fuquay) pH 

5.3, 0.46% OC, 0.79% OM

122

(DFOP)

810

(DFOP)

t1⁄2 slow = 310

(DFOP)

MRIDs 

45865312, 

46925806

acceptable

Previously reported half-life value was 187 days 

for fluoxastrobin. The registrant responded 

(MRID 46925806) to the deficiencies in the data 

evaluation report and the acceptability of the 

anaerobic aquatic studies submitted in support 

of the fluoxastrobin registration (MRID 

45865312). The study was reevaluated and 

determined to be acceptable as EFED does not 

expect fluoxastrobin to sorb to the glass test 

apparatus to a sufficient degree to affect the 

study results, as demonstrated by the material 

balance. Unextracted residues were observed 

at concentrations up to 36.2% at 360 DAT.

Terrestrial 

Field 

Dissipation

835.6100

Burscheid, Germany/Silt 

loam soil

78.8, 

(SFO) Not 

calculated -

MRIDs

45865317,

45865402

Transformation was observed to be biphasic; 

however, the kinetic analyses were not updated 

as the results are not used for modeling. Monheim, Germany/Sandy 

loam soil

92.4

(SFO)
25

Study/ 

Guideline

System Name/ 

Characteristics

Kinetic Model Fitteda Value 

and Unit (Fitting Equation)

Representative Half-life 

Value

--Value Used to Derive 

Model Input Values 

(days)b--

Source/ 

Classification

Comments

DT50 (days) DT90 (days)

Thurston, Great 

Britain/Sandy clay loam soil

169.1

(SFO)

Feuquerolles, France/Silt 

loam soil

123.8

(SFO)

Watsonville, 

California/sandy loam

578

(SFO)

Not 

calculated - MRID45865318

The kinetic analysis were not updated as the 

results are not used for modeling

North Rose, New 

York/Loamy sand

533

(SFO)

Not 

calculated - MRID 45865320

The kinetic analysis were not updated as the 

results are not used for modeling

North Rose, New 

York/Loamy sand (turf)

347 

(SFO)

Not 

calculated - MRID 45865324

The kinetic analysis were not updated as the 

results are not used for modeling

239 Not 

calculated -

MRID

45865323

Supplemental

Turf; Frozen storage stability study was 

inadequate. Test samples were stored frozen 

for up to 1,032 days (ca. 34 months) prior to 

extraction, while storage stability data were 

only provided for up to a period of 15 months. 

Leaching was observed for fluoxastrobin and to 

a greater extent for the E-des-chlorophenyl.

Aquatic Field 

Dissipation

835.6200

Silt loam (rice paddy, 

Arkansas) pH 5.3, 0.8% OC 

(0-5 cm) 

135 (total 

system 

following 

second 

application; 

DFOP slow 

half-life)

Not 

calculated -

MRID

48532004

Upgradeable

The storage stability data reported were 

insufficient to determine the stability of 

fluoxastrobin. Soil and water samples were not 

analyzed for transformation products. An 

independent laboratory method validation was 

not provided. 

DT50 and DT90 values were calculated using single first-order (SFO), double first- order in parallel (DFOP), or indeterminate- order equation (IORE). For DFOP, the overall DT50 

and DT90 are reported when available. The equations can be found in the document, Standard Operating Procedure for Using the NAFTA Guidance to Calculate Representative 

Half-life Values and Characterize Pesticide Degradation, U.S. Environmental Protection Agency, March 23, 2012.

The value used to estimate a model input value is the calculated SFO DT50, TIORE, or the 2nd DT50 from the DFOP equation. The model chosen is consistent with that 

recommended using the, Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media, Health Canada, U.S. Environmental Protection Agency, 

December 21, 2012. The same model used to estimate the value used to derive a model input, is used to describe the DT50 and DT90 results.
26

IV. RECEPTORS

Table IV.1 and Table IV.2 provide a summary of the terrestrial and aquatic toxicity data, respectively, 

and the most sensitive surrogate species tested to characterize the potential acute and chronic 

ecological effects of fluoxastrobin. Table IV.3 provides information on the non-guideline toxicity data 

available for fluoxastrobin. 

Table IV.1. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for 

Fluoxastrobin

Study Type Endpoint Value Used in Risk 

Assessment

Toxicity 

Classification Study Rating MRID Comments

Acute 

Mammalian 

Oral

870.1100

(rat)

LD50 > 2,000 mg a.i./kgbw

Practically 

nontoxic Acceptable 45865612 -

Mammalian 

Reproduction

870.3800

(rat)

NOAEC/

LOAEC 70 mg a.i./kg-bw - Acceptable 45865634

Avian Acute Oral

850.2100

(Bobwhite)

LD50

> 2,000 mg a.i./kgbwPractically 

Nontoxic Acceptable 45865422 -

Avian Dietary 

Toxicity

850.2200

(Bobwhite)

LC50

> 4845 mg a.i./kgdiet - Acceptable 45865423 -

Avian 

Reproductive 

(chronic) 

850.2300

(Mallard Duck)

NOAEC/

LOAEC

461 mg a.i./kg-diet/

1394 mg a.i./kg-diet - Acceptable 45865426

Based on 

reductions 

in female 

body weight 

and egg 

production.

Honey Bee Adult 

Acute Oral And 

Contact Toxicity

(850.3020)

LD50

> 200 μg a.i./bee 

(contact)

Practically 

Nontoxic Acceptable 45865427 -

Terrestrial Plant 

Toxicity, Seedling 

Emergence

850.4100

EC25 > 0.54 lb a.i./acre -

Acceptable 45865428

-

NOAEC 0.54 lb a.i./acre -

No 

reductions 

exceeded 

25%
27

Study Type Endpoint Value Used in Risk 

Assessment

Toxicity 

Classification Study Rating MRID Comments

Terrestrial Plant 

Toxicity,

Vegetative Vigor

850.4150

EC25 > 0.54 lb a.i./acre -

Acceptable 45865428

-

NOAEC 0.54 lb a.i./acre -

No 

reductions 

exceeded 

25%

Table IV.2. Summary of the Most Sensitive Endpoints from Aquatic Toxicity Studies for Fluoxastrobin

Study

Guideline

(taxa)

Endpoint Toxicity Value Toxicity 

Classification Study Rating MRID Comments

Fish Acute 

Toxicity, 

Freshwater

850.1075

(Rainbow Trout)

LC50 0.435 mg a.i./L Highly Toxic Acceptable 45865414 -

Fish

Early-Life Stage, 

Freshwater

850.1400

(Rainbow Trout)

NOAEC/

LOAEC

0.0557 mg a.i./L

>0.0557 mg a.i./L - Supplemental 45865420

No effects at 

any 

concertation 

tested (no 

LOAEC was 

established)

Aquatic 

Invertebrate

Acute Toxicity, 

Freshwater

850.1010

(Gammarus pulex)

EC50 0.12 mg a.i./L Highly Toxic Supplemental 46080402

Study was 

conducted

with nonguideline 

species

Life-Cycle 

Freshwater 

Invertebrate

NOAEC 0.045 mg a.i./L -

Value based on acute-to-chronic ratio using 

acute/chronic data on daphnids

0.48 mg a.i./L (MRID 45865406) / 0.18 mg a.i./L 

(MRID 45865418) x 0.12 mg a.i./L (MRID 

46080402)

Fish Acute 

Toxicity,

Estuarine/

Saltwater

850.1075

(Sheepshead 

Minnow)

96-hr 

LC50

>1.374 mg a.i./L Moderately 

Toxic Supplemental 45865417

Reported 

practical 

solubility in 

salt water is 

1600 μg/L.
28

Study

Guideline

(taxa)

Endpoint Toxicity Value Toxicity 

Classification Study Rating MRID Comments

Invertebrate

Acute Toxicity 

Estuarine/

Saltwater 

850.1025 

(eastern oyster)

96-hr 

EC50

0.83 mg a.i./L Highly Toxic Supplemental 45865410

New shell 

growth did not 

meet 

minimum 

requirement.

Invertebrate

Acute Toxicity 

Estuarine/

Saltwater 

850.1035 

(mysid shrimp)

96-hr 

LC50

0.0516 mg a.i./L Highly Toxic Acceptable 45865411

The solubility 

limit under the

test conditions 

(salt water) 

was not 

provided; 

however, 

solubility is 

expected to be 

much higher 

than test 

concentrations

. 

Chronic Life-Cycle 

Estuarine/ Marine 

Invertebrate 

850.1350

(mysid)

NOAEC/

LOEC

0.00061 mg a.i./L/

0.00119 mg a.i./L - Supplemental 45865419

Based on 

reduced 

survival and 

growth

Whole Sediment: 

Acute Freshwater 

Invertebrates 

850.1735

(midge)

10-day

Sediment:

EC50 = 103 mg a.i./kg

NOAEC = 12 mg a.i./kg

LOEC = 31 mg a.i./kg

- In Review 49317701

This study is 

under review. 

The endpoints 

provided are 

study author 

reported 

values based 

on survival.

Whole Sediment: 

Acute Marine 

Invertebrates

850.1740

10-day

Sediment:

LC50 = 0.51 mg a.i./kg

NOAEC = 0.19 mg a.i./kg

LOEC = 0.38 mg a.i./kg

- In Review 49317702

This study is 

under review. 

The endpoints 

provided are 

study author 

reported 

values based 

on survival.

Aquatic Plant, Tier 

I – Vascular 

850.4400

(Duckweed)

EC50 1.2 mg a.i./L -

Acceptable 45865430

-

NOAEC 0.16 mg a.i./L -

Based on 

reduced frond 

number.

EC50 0.26 mg a.i./L - Acceptable 45865431 -
29

Study

Guideline

(taxa)

Endpoint Toxicity Value Toxicity 

Classification Study Rating MRID Comments

Aquatic Plant, Tier 

I – Non-Vascular

850.5400 (green 

algae)

NOAEC 0.076 mg a.i./L -

Based on 

reduced cell 

density

For aquatic plants, the EC50 is used to calculate the non-listed plant RQ and the NOAEC is used to calculate the listed plant RQ.
30

Table IV.3. Summary of the Non-Guideline Toxicity Endpoints for Fluoxastrobin

Study Endpoint Toxicity Value Toxicity 

Classification Study Rating MRID Comment

Chronic Indoor 

Microcosm, 

amphipod

LC50 0.086 mg a.i./L

Supplemental 46404901

Day 7

NOEC 0.015 mg a.i./L Day 28

Earthworm 

toxicity, 

Subchronic

LR50

> 1000 mg 

a.i./kg Supplemental 45865502

A. Ecological Incidents

Three incident databases are available: 1) the Ecological Incident Information System v. 2.1.1 (EIIS), 

maintained by EFED; 2) the Avian Incident Monitoring System (AIMS), maintained by the American Bird 

Conservancy; and, 3) the Incident Data System (IDS) maintained by OPP. These databases were searched 

and the results are summarized below.

The Ecological Incident Information System (EIIS) database was queried on November 5, 2015 for 

incidents related to fluoxastrobin use and no incidents were identified. 

The Avian Incident Monitoring System (AIMS), a database administered by the American Bird 

Conservancy, was not working properly and was not queried; however, the AIMS database has not been 

updated since the last fluoxastrobin assessment was conducted and no incidents to birds were reported 

at that time.

A query of the aggregate Incident System (IDS) on November 9, 2015 reported no incidents.

The absence of documented incidents in these databases does not necessarily mean that such incidents 

did not occur. Mortality incidents must be seen, reported, investigated, and submitted to the Agency in 

order to be recorded in the incident databases. In addition, incident reports for non-target organisms 

typically provide information only on mortality events and plant damage. Sublethal effects in organisms 

such as abnormal behavior, reduced growth and/or impaired reproduction are rarely reported, except 

for phytotoxic effects in terrestrial plants.

B. Exposure Pathways of Concern

Based on the use pattern and environmental fate characteristics of this pesticide, the following exposure 

pathways are expected to be most relevant for determining exposure and potential risk to non-target 

organisms:

• Direct spray

• Spray drift

• Runoff

• Leaching to groundwater followed by irrigation 

In addition, terrestrial animals that use treated fields may be exposed to fluoxastrobin from consuming 

contaminated plants and invertebrates, dermal absorption, and drinking from contaminated puddles. 

Drinking water exposure pathways were screened using SIP (Screening Imbibition Program) and indicate 
31

that drinking from contaminated puddles is not a pathway of potential concern for fluoxastrobin. The 

potential for inhalation exposure was screened using STIR (Screening Tool for Inhalation Risk). Based on 

this analysis inhalation is a pathway of low concern.

SIP and STIR are described in detail at http://www.epa.gov/oppefed1/models/terrestrial/index.htm and 

the SIP and STIR model inputs and outputs for fluoxastrobin are available in APPENDICES B AND C, 

respectively.

While fluoxastrobin is expected to be taken up by plants and translocated, concentrations in nectar and 

pollen are unknown. Nevertheless, both oral and contact exposure to pollinators is expected to occur as 

a result of direct spray onto crop during blooming periods.

V. ANALYSIS PLAN

A. Ecological Risk Assessment

1. Stressors of Concern 

Fluoxastrobin is the only residue considered as a stressor of concern. Based on available data for a 

variety of taxa, fluoxastrobin is expected to be considerably more toxic than its environmental 

degradation products to non-target species. 

Data on the degradate HEC 7155 have been submitted for aquatic invertebrate Daphnia magna (MRID 

45865409), the fresh water fish rainbow trout (MRID 45865416), the aquatic non-vascular plant green 

alga (MRID 45865501). Data on the transformation products HEC 7180 have been submitted for the 

aquatic invertebrate Daphnia magna (MRID 45865408), the aquatic non-vascular plant green alga (MRID 

45865432), and the fresh water fish rainbow trout (MRID 45865415). For both compounds, the 

sensitivity of the test species to the transformation products appears to be orders of magnitude less 

than the sensitivity to the parent fluoxastrobin. The Health Effects Division has not indicated that 

fluoxastrobin environmental transformation products are residues of concern. No additional data, are 

available to know the toxicity of the transformation products to other taxa; however, based on the 

available data, the transformation products appear to be less toxic than the parent. 

2. Measures of Exposure

In order to estimate risks of fluoxastrobin exposure to aquatic and terrestrial organisms, all exposure 

modeling and resulting risk conclusions will be made based on maximum application rates, application 

methods, and any mitigation measures specifically indicated on the label. The models that will be used 

to predict the EECs are discussed on OPP’s model website.11

Available monitoring data will be evaluated and considered in an assessment conducted for Registration 

Review.

Exposure to terrestrial animals is estimated using the Terrestrial Residue Exposure (T-REX) model. 

Exposure to terrestrial plants is estimated using the TerrPlant model. For terrestrial plants, exposure is 

based on the calculated maximum application rates with assumed exposure from runoff, but not spray 

 11 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment
32

drift. A description of these models may be found at: http://www2.epa.gov/pesticide-science-andassessing-pesticide-risks/models-pesticide-risk-assessment.

3. Measure of Effects

Ecological effects data are used as measures of direct and indirect effects to biological receptors. Data 

are typically obtained from registrant-submitted studies and from literature studies identified by 

ECOTOX (USEPA 2014). The ECOTOX database provides more ecological effects data in an attempt to 

bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and potential 

chemical mixture toxicity data for aquatic life, terrestrial plants, and wildlife. ECOTOX was created and is 

maintained by the U.S. EPA, Office of Research and Development, and the National Health and 

Environmental Effects Research Laboratory's Mid-Continent Ecology Division. Toxicity data presented in 

Section IV of this problem formulation will be used in the quantitative risk assessment. Any additional 

toxicity data submitted by the registrant, as well as relevant toxicity information found in the open 

literature, will also be considered.

4. Integration of Exposure and Effects

Exposure and effects will be integrated in an updated risk assessment for fluoxastrobin (described in the 

stressors of concern section of this document), incorporating new data (described in the identification of 

data gaps section of this document) and analytical approaches (current as of the time of the updated 

assessment), label clarifications, and any additional information obtained since the previous risk 

assessments were conducted. 

5. Endangered Species Assessments

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate 

risks to federally listed threatened and endangered (listed) species from registered uses of pesticides in 

accordance with the Joint Interim Approaches developed to implement the recommendations of the 

April 2013 National Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened 

Species from Pesticides. The NAS report outlines recommendations on specific scientific and technical 

issues related to the development of pesticide risk assessments that EPA and the Services must conduct 

in connection with their obligations under the ESA and FIFRA. EPA will address concerns specific to 

fluoxastrobin in connection with the development of its final registration review decision for 

fluoxastrobin. 

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries (the Services), and 

USDA released a white paper containing a summary of their joint Interim Approaches for assessing risks 

to listed species from pesticides. These Interim Approaches were developed jointly by the agencies in 

response to the NAS recommendations, and reflect a common approach to risk assessment shared by 

the agencies as a way of addressing scientific differences between the EPA and the Services. Details of 

the joint Interim Approaches are contained in the November 1, 2013 white paper, Interim Approaches 

for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the 

National Academy of Sciences April 2013 Report.

Given that the agencies are continuing to develop and work toward implementation of the Interim 

Approaches to assess the potential risks of pesticides to listed species and their designated critical 

habitat, this ecological problem formulation supporting the Preliminary Work Plan for fluoxastrobin

does not describe the specific ESA analysis, including effects determinations for specific listed species or 

designated critical habitat, to be conducted during registration review. While the agencies continue to 
33

develop a common method for ESA analysis, the planned risk assessment for the registration review of 

fluoxastrobin will describe the level of ESA analysis completed for this particular registration review 

case. This assessment will allow EPA to focus its future evaluations on the types of species where the 

potential for effects exists, once the scientific methods being developed by the agencies have been fully 

vetted. Once the agencies have fully developed and implemented the scientific methods necessary to 

complete risk assessments for listed species and their designated critical habitats, these methods will be 

applied to subsequent analyses of fluoxastrobin as part of completing this registration review.

6. Endocrine Disruptor Screening Program

Fluoxastrobin was not included in the first group of 67 chemicals issued an order to conduct Tier 1 EDSP 

testing. Tier 1 screening results for List 1 chemicals are available at http://www2.epa.gov/ingredientsused-pesticide-products/endocrine-disruptor-screening-program-tier-1-assessments. For additional

information on the EDSP, visit http://www.epa.gov/endo/.

B. Drinking Water 

Unless additional data are provided on unextracted residues observed in the environmental fate studies 

an updated drinking water assessment for registration review will be completed in order to capture the 

uncertainty associated with these unextracted residues. Unextracted residues were not addressed in 

previous drinking water assessments. The most recent drinking water assessment conducted for seed 

treatment of corn (based on applications to turf) will be used as the basis for the updated assessment

following the unextracted residues guidance.

12

VI. PRELIMINARY IDENTIFICATION OF DATA GAPS

A. Environmental Fate

Table VI.1 identifies environmental fate studies by MRID that offer data for each guideline requirement, 

as well as study classifications and whether or not further data are needed in order to support risk 

assessment.

B. Ecological Effects

Table VI.2 and identify ecological effects studies for aquatic and terrestrial organisms, respectively, that 

provide data for each guideline requirement. These tables also identify the study classifications and 

indicate whether EFED recommends requesting additional data in order to support risk assessment and 

the rationale for the data request. 

 12 Brady, D. Guidance for Addressing Unextracted Residues in Laboratory Studies, September 12, 2014
34

Table VI.1. Environmental Fate Data for Fluoxastrobin and Its Environmental Transformation Products

OCSPP 

Guideline

Data 

Requirement Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed? Comments

835.2120 Hydrolysis

Hellpointner, E. (1999) Hydrolysis of 

(Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC 5725 in 

Sterile Aqueous Buffer Solutions: Lab Project Number: M 

1110904-6: MR-058-99: PF-E/MR. Unpublished study 

prepared by Bayer AG. 44 p.

45865304 Acceptable

No

--

Brumhard, B. (2001) Aqueous Hydrolysis of HEC5725 

Under Conditions of Processing Studies: Lab Project 

Number: M1771 136-6: MR-426-01: PF-E/MR. 

Unpublished study prepared by Bayer AG. 34 p.

45865305 Unacceptable

835.2240 Aqueous 

Photolysis

Stupp, H. (2001) Photolysis of HEC 5725 in Aqueous 

Solution: Lab Project Number: MR 072-00: M 1120905-8. 

Unpublished study prepared by Bayer AG. 81 p.

45865306 Acceptable

No --

Hellpointner, E. (2001) Determination of the Quantum 

Yield and Assessment of the Environmental Half-Life of 

the Direct Photogradation in Water of HEC5725: Lab 

Project Number: M1430940-1: MR 540/00. Unpublished 

study prepared by Bayer AG. 39 p.

45865307

Schafer, H. (2001) Calculation of a DT-50 Value of 

HEC5725 Metabolite Oxazepine Generated by Photolysis 

in Aqueous Solution: Lab Project Number: MR-262/0 1: 

MR262-01: P 668 01 6521. Unpublished study prepared 

by Bayer Ag. 16 p.

45865403 Acceptable

Stupp, H. (20) Photolysis of HEC5725 in Water/Sediment 

Systems: Lab Project Number: MR 322/01: M 112 1135-

4: PF-E/MR. Unpublished study prepared by Bayer AG. 

54 p.

45865327 Supplemental

835.2410 Soil Photolysis

Hellpointner, E. (2001) Photolysis of HEC5725 on Soil 

Surface: Lab Project Number: M1 130939-6: MR 347/00. 

Unpublished study prepared by Bayer AG. 92 p.

45865308 Acceptable No

--
35

OCSPP 

Guideline

Data 

Requirement Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed? Comments

835.4100 Aerobic Soil 

Metabolism

Brumhard, B.; Eberhardt, R. (2001) Aerobic Degradation 

of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC5725 in 

Soil Laacher Hof AXXa: Lab Project Number: M 125 0886-

O: MR 230/01: THS 4727. Unpublished study prepared 

by Bayer AG. 58 p.

45865309 Supplemental

No

The soil extraction methods utilized in 

these study are not considered exhaustive 

and an increasing amount of nonextracted residues were observed. In 

absence of additional, the non-extracted 

residues will be considered in the 

calculation of the model input values used 

for risk assessment. 

Brumhard, B.; Eberhardt, R. (2001) Aerobic Degradation 

and Metabolism of (Methoxyiminotolyl-Ring-UL-(Carbon 

14)-and (Pyrimidine-2-(Carbon 14) HEC5725 in Thre 

Soils: Lab Project Number: M 125 0894-9: MR-231/01: 

MR-23 1-O 1. Unpublished study prepared by Bayer Ag. 

124 p.

45865310 Supplemental

Stupp, H. (2002) HEC2725 Carboxylic Acid: Degradation 

of HEC5725 Carboxylic Acid (HEC71 SO) in Three Soils 

Under Aerobic Conditions: Lab Project Number: M125 

1146-O: MR522/01. Unpublished study prepared by 

Bayer Ag. 54 p.

45865311 Unacceptable

Material balances were incomplete as the 

soil extract were analyzed for parent HEC 

5725-carboxylic acid. 

835.4200 Anaerobic Soil 

Metabolism No data No --

835.4300 Aerobic Aquatic 

Metabolism

Hellpointner, E. (2002) Anaerobic Aquatic Degradation 

and Metabolism of HEC5725: Lab Project Number: 

M152006-3: MR-406/01: HPO-225. Unpublished study 

prepared by Bayer Ag. 76 p.

45865312

Acceptable No

The registrant responded (MRID 

46925806) to the deficiencies in the data 

evaluation report and the acceptability of 

the aerobic aquatic study submitted in 

support of the fluoxastrobin registration 

(MRID 458653-12 and 13). The study was 

reevaluated and determined to be 

acceptable as EFED does not expect 

fluoxastrobin to sorb to the glass test 

apparatus to a sufficient degree to affect 

the study results, as demonstrated by the 

material balance.

Allan, J. (2006) Response to the EPA Data Evaluation 

Reports on the Acceptability of the Fluoxastrobin 

Aerobic and Anaerobic Aquatic Studies. Project Number: 

HEC083006. Unpublished study prepared by Bayer 

CropScience LP. 7 p.

46925806

835.4400

Anaerobic 

Aquatic 

Metabolism

Brumhard, B.; Oi, M. (2002) Aerobic Degradation and 

Metabolism of (Methoxyiminotolyl-Ring-UL-(Carbon 14)) 

HEC 5725 in the Water/Sediment System: Lab Project 

Number: M15 1 0903-9: MR-396/01: M151 0903-9. 

Unpublished study prepared by Bayer Ag. 75 p.

45865313 Acceptable No
36

OCSPP 

Guideline

Data 

Requirement Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed? Comments

Durando, J. (2008) Fluoxastrobin-Myclobutanil SC: 

Primary Eye Irritation Study in Rabbits. Project Number: 

26083, P324. Unpublished study prepared by Product 

Safety Laboratories. 16 p.

46925806

835.1230

835.1240

Adsorption/ 

desorption and 

Leaching

Hein, W. (2000) Adsorption/Desorption of (Phenyl-UL-

(Carbon 14)) HEC 7155 (Deschlorophenyl HEC 5725) on

Four Different Soils: Lab Project Number: BAY33: FM776. 

Unpublished study prepared by Staatliche Lehr-und 

Forschungsanstalt fuer Landwirtschaft. 44 p.

45865314 Acceptable

No --

Fent, G. (1998) Adsorption/Desorption of 

(Methoxyiminotolyl-Ring-UL-(Carbon 14)) HEC5725 on 

Four Different Soils: Lab Project Number: BAY27: FM767. 

Unpublished study prepared by Staatliche Lehr-und 

Forschungsanstalt fuer Landwirtschaft. 46 p.

45865315 Acceptable

Stupp, H. (2001) Adsorption and Desorption of HEC5725-

Carboxylic Acid in Soil: Lab Project Number: MR411-01: 

M1311123-2: MR41 1/01. Unpublished study prepared 

by Bayer Ag. 63 p.

45865316 Acceptable

Sommer, H. (2001) Estimation of the Adsorption 

Coefficient (Koc) of HEC57275-Carboxylic Acid on Soil 

Using High Performance Liquid Chromatography (HPLC): 

Lab Project Number: M 138 1130-7: 247/01: MR247-01. 

Unpublished study prepared by Bayer Ag. 34 p.

45865401 Supplemental

835.6100 Terrestrial Field 

Dissipation

Schramel, O. (2001) Dissipation of HEC5725 (100 EC) in 

Soil under Field Conditions: France, Germany, Great 

Britain, Italy: Lab Project Number: R812390: R812404: 

R812412. Unpublished study prepared by Bayer Ag. 184 

p. 45865317 Supplemental No

Patterns of formation and decline of the 

fluoxastrobin transformation products

were not adequately determined. The 

only transformation product detected in 

the soil, HEC5725-E-des-chlorophenyl,

was not detected above the LOQ at five of 

the eight test sites and was not detected 

at more than three sampling intervals at 

any of the test sites.
37

OCSPP 

Guideline

Data 

Requirement Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed? Comments

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in California Soil, 1999: Final 

Report: Lab Project Number: AG990009: F99568-001: 

99.109. Unpublished study prepared by Battelle 

Memorial Institute and Plant Services, Inc. 236 p.

45865318 Acceptable See footnote 1.

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in Georgia Soil, 1999: Final 

Report: Lab Project Number: AG990010: F99541-001: 

HC022102. Unpublished study prepared by Battelle 

Memorial Institute and Bayer Research Farm. 197 p.

45865319 Supplemental

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in New York Soil, 1999: Final 

Report: Lab Project Number: AG990011: F99565-001: 

AR99352. Unpublished study prepared by Battelle 

Memorial Institute and A.C.D.S. Research, Inc. 241 p.

45865320 Acceptable See footnote 1.

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in New York Soil, 1999: Final 

Report: Lab Project Number: HC022104: 200217: 

AG990012. Unpublished study prepared by Battelle 

Memorial Institute and A.C.D.S. Research, Inc. 174 p.

45865321 Supplemental

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in Washington Soil, 1999: Final 

Report: Lab Project Number: AG990013: F99538-001: 

99-40. Unpublished study prepared by Battelle 

Memorial Institute and Qualls Agricultural Laboratories, 

Inc. 191 p.

45865322 Supplemental

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in California Turf, 1999: Final 

Report: Lab Project Number: AG990014: HC022701: 

200219. Unpublished study prepared by Battelle 

Memorial Institute and Plant Sciences, Inc. 253 p.

45865323 Acceptable See footnote 1.
38

OCSPP 

Guideline

Data 

Requirement Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed? Comments

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in New York Turf, 1999: Final 

Report: Lab Project Number: AG990015: F99565-001: 

HC022702. Unpublished study prepared by Battelle 

Memorial Institute and A.C.D.S. Research, Inc. 261 p.

45865324 Acceptable See footnote 1.

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in Manitoba Soil, 1999: Final 

Report: Lab Project Number: AG990024: F99559-001: 

HC022107. Unpublished study prepared by Battelle 

Memorial Institute and Enviro-Quest. 188 p.

45865325 Supplemental

Bauer, M.; Andre, J.; Zielinski, C. (2002) Terrestrial Field 

Dissipation of HEC 5725 in Prince Edward Island Soil, 

1999: Final Report: Lab Project Number: AG990025: 

F99564-001: HC022106. Unpublished study prepared by 

Battelle Memorial Institute and Atlantic AgriTech. 173 p.

45865326 Supplemental

Storage 

Stability

Andre, J. (2005) Freezer Storage Stability of HEC 5725 

and Relevant Metabolites on Soil from California, 

Washington, Georgia, New York, Manitoba, and Prince 

Edward Island. Project Number: 201275, AG010002. 

Unpublished study prepared by Battelle. 102 p.

46569701 Acceptable No

While the current storage stability data 

are not adequate, the assumption is that 

fluoxastrobin is stable.

Schramel, O. (2001) Determination of the Storage 

Stability of HEC5725-E-Isomer, HEC5725-Z-Isomer, 

HEC5725-E-Des-Chlororphenyl and HEC5725-E/ZCarboxylic Acid in Soil After a Storage Period of 14 

Months: Lab Project Number: P64190032: M R-646199: 

MR-646-99. Unpublished study prepared by Bayer Ag. 

85 p.

45865332 na No
39

OCSPP 

Guideline

Data 

Requirement Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed? Comments

835.6200 Aquatic Field 

Dissipation

Culligan, J. (2009) Aquatic Field Soil Dissipation of Evito 

480 SC Fungicide Following Application to Flooded Rice 

Field in Arkansas. Project Number: ARAP/07A/004. 

Unpublished study prepared by Ag Research Associates 

and ALS Laboratory Group, Environmental. 185 p. 48532004 Upgradable no

Several study deficiencies were noted 

including: the storage stability data 

reported were insufficient to determine 

the stability of fluoxastrobin in test site 

water and soil; soil cores were not 

sectioned into increments; a plot history 

was not reported; meteorological data for 

the study period were not provided; and 

an independent laboratory method 

validation was not performed.

850.6100

850.7100

Analytical 

Method in Soil

Schramel, O. (2001) Residue Analytical Method 00611 

(MR-645/99) for the Determination of HEC 5725-EIsomer, HEC 5725-Z-Isomer, HEC-5725-E-DesChlorophenyl and HEC 5725-E/Z-Carboxylic Acid in Soil 

by HPLC-MS/MS: Lab Project Number: P 60190031: MR645/99: 00611. Unpublished study prepared by Bayer 

AG. 74 p.

45865328 Acceptable

no

Environmental Chemistry Method

Bauer, M. (2002) Independent Laboratory Validation of 

Bayer Method 00611 "Residue Analytical Method for the 

Determination of HEC 5725-E-Isomer, HEC 5725-ZIsomer, HEC-5725-E-Des-Chlorophenyl and HEC 5725-

E/Z-Carboxylic Acid in Soil by HPLC-MS/MS": Lab Project 

Number: AG000082: HC112101: 200317. Unpublished 

study prepared by Battelle. 85 p.

45865329 Acceptable

Independent laboratory validation of 

MRID 45865328. 

Analytical 

Method in 

Water

Sommer, H. (1999) Method for Determination of HEC 

5725 and HEC 7155 in Test Water from Aquatic Toxicity 

Test by HPLC: Lab Project Number: P 604 97052: 

109230: 00579. Unpublished study prepared by Bayer 

Ag. 15 p.

45865330 Acceptable

yes

Results are to support aquatic toxicity 

testing. 

Sommer, H. (2001) Enforcement Methods for 

Determination of HEC 5725 in Drinking and Surface 

Water by HPLC-MS/MS: Lab Project Number: P 684 

017047: MR-201/01: 00692. Unpublished study 

prepared by Bayer Ag. 27 p.

45865331 Acceptable

No independent laboratory validation 

study has been provided to support this 

environmental chemistry method 

(enforcement method). 
40

OCSPP 

Guideline

Data 

Requirement Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed? Comments

165-4 

850.1730

Fish Bioconcentration

Dorgerloh, M.; Weber, E. (2001) (Carbon 14)-HEC 5725--

Bioconcentration and Biotransformation in Bluegill 

(Lepomis macrochirus) under Flow-Through Conditions: 

Lab Project Number: DOM 20032: E 244 1857-1: DOMA 

20032. Unpublished study prepared by Bayer Ag. 160 p.

45865421 Supplemental no

The bioaccumulation and 

biotransformation of fluoxastrobin were 

conducted in separate experiments using 

bluegill sunfish at different life stages; 

therefore, it is uncertain whether the 

formation and distribution of 

transformation products in the adult fish 

tested in the biotransformation 

experiment would be the same for the 

juvenile fish tested in the bioaccumulation 

experiment. In addition, no storage 

stability data for fish tissues were

submitted, although the fish samples 

were stored frozen for up to 6 months 

prior to extraction and analysis. BCF 

values were calculated based on total 

radioactivity. 

1. The supplemental storage stability study (MRID 46569701) indicating fluoxastrobin and relevant transformation products are stable (37-38 months) in the test soils.
41

Table VI.2. Aquatic Ecological Effects Data for Fluoxastrobin

OCSPP

Guideline

Data 

Requirement

Test Material

Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data needed 

for risk 

assessment?

Comments

850.1010

Aquatic 

Invertebrate

Acute Toxicity, 

Freshwater

Heimbach, F. (1999) Acute Toxicity of HEC 

5725 (tech.) to Water Fleas (Daphnia 

magna): Lab Project Number: HBF/DM 211: 

E 320 1674-3. Unpublished study prepared 

by Bayer Ag. 47 p.

45865406 

(TGAI) Acceptable

No

Daphnia magna

Dorgerloh, M.; Sommer, H. (2002) Acute 

Toxicity of HEC 5725 (E:Z; 65:35) to Water 

Fleas (Daphnia magna): Lab Project 

Number: E 320 2187-3: DOMA 21071. 

Unpublished study prepared by Bayer Ag. 

51 p.

45865407

E:Z (65:35) Acceptable

Hendel, B.; Sommer, H. (2001) Acute 

Toxicity of HEC 5725-Carboxylic Acid (tech.) 

to Water Fleas (Daphnia magna): Lab 

Project Number: E 320 1976-8: HDB/DM 

249. Unpublished study prepared by Bayer 

Ag. 26 p.

45865408

(HEC 7180) Acceptable HEC 5725-Carboxylic Acid

Daphnia magna

Hendel, B. (2000) Acute Toxicity of HEC 

5725-Deschlorophenyl to Water Fleas 

(Daphnia magna): Lab Project Number: E 

320 1800-4: HDB/DM 227. Unpublished 

study prepared by Bayer Ag. 24 p.

45865409

(HEC 7155) Acceptable HEC 5725-Deschlorophenyl

Daphnia magna

van Wijngaarden, R.; (2003) Acute Toxicity 

of Fluoxastrobin to Freshwater 

Invertebrates: Final Report. Project 

Number: ALT/RW/2003/1, 

ALTERRA/RW/2003/1. Unpublished study 

prepared by Alterra, Green World Research. 

93 p.

46080402

(TGAI) Supplemental

This study was conducted with 

aquatic invertebrate species (Daphnia 

gr. galeata, Simocephalus vetulus, 

Acanthocyclops venustus,

Gammarus pulex, Asellus aquaticus, 

Chaoborus obscuripes, and Cloeon 

dipterum).
42

OCSPP

Guideline

Data 

Requirement

Test Material

Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data needed 

for risk 

assessment?

Comments

van Wijngaarden, R. (2003) Screening 

Studies on the Effects of Fluoxastrobin to 

Freshwater Invertebrates. Project Number: 

F03069. Unpublished study prepared by 

Alterra, Green World Research. 12 p.

46080401

(TGAI) Invalid No solvent control was tested.

850.1025

Invertebrate

Acute Toxicity 

Estuarine/

Saltwater 

Ward, T.; Wyskiel, D.; Boeri, R. (2002) HEC 

5725: A 96-Hour Shell Deposition Test with 

the Eastern Oyster (Crassostrea virginica): 

Lab Project Number: 99-B-133: HC831501: 

2357-BR. Unpublished study prepared by 

T.R. Wilbury Laboratories, Inc. 30 p.

45865410

(TGAI) Supplemental No

New shell growth in the solvent 

control did not satisfy the minimum 

requirement of 2.0 mm at 1.5 ± 1.3 

mm; however, the shell deposition 

observed in the negative control was 

2.1 ± 0.9 mm; eastern oyster 

850.1035

850.1045

Boeri, R.; Wyskiel, D.; Ward, T. (2002) HEC 

5725: A 96-Hour Flow-Through Acute 

Toxicity Test with the Saltwater Mysid, 

(Americamysis bahia): Lab Project Number: 

99-B-131: HC833101: 2358-BR. 

Unpublished study prepared by T.R. 

Wilbury Laboratories, Inc. 31 p.

45865411

(TGAI) Acceptable No Salt Water Mysid

850.1075

Fish Acute 

Toxicity, 

Freshwater

Dorgerloh, M. (1999) HEC 5725 Acute 

Toxicity (96 Hours) to Bluegill (Lepomis 

macrochirus) in a Static Test: Lab Project 

Number: E 252 1696-1: DOMA 99089: 

00579. Unpublished study prepared by 

Bayer Ag. 48 p.

45865412 

(TGAI) Acceptable

No

Bluegill

Dorgerloh, M. (2000) HEC 5725 Acute 

Toxicity (96 Hours) to Common Carp 

(Cyprinus carpio) in a Static Test: Lab 

Project Number: DOMA 20011: E 

28601782-4. Unpublished study prepared 

by Bayer Ag. 37 p.

45865413

(TGAI) Supplemental
43

OCSPP

Guideline

Data 

Requirement

Test Material

Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data needed 

for risk 

assessment?

Comments

Dorgerloh, M. (1999) HEC 5725 Acute 

Toxicity (96 Hours) to Rainbow Trout 

(Oncorhynchus mykiss) in a Static Test: Lab 

Project Number: E 250 1605-9: DOMA 

99065: 00579. Unpublished study prepared 

by Bayer Ag. 48 p.

45865414

(TGAI) Acceptable Rainbow Trout

Dorgerloh, M.; Sommer, H. (2001) HEC 

5725-Carboxylic Acid--Acute Toxicity (96 

Hours) to Rainbow Trout (Oncorhynchus 

mykiss) in a Static Test (Limit Test): Lab 

Project Number: E 280 2104-7: DOMA 

21020: 00683. Unpublished study prepared 

by Bayer Ag. 41 p.

45865415

(HEC 7180) Supplemental

Rainbow Trout; the study was 

conducted at only one concentration

(95.7 mg/L), and the mean-measured 

concentration was below the limit 

level of 100 ppm.

Dorgerloh, M. (2000) HEC 5725-

Deschlorophenyl--Acute Toxicity (96 Hours) 

to Rainbow Trout (Oncorhynchus mykiss) in 

a Static Test: Lab Project Number: E 280 

1761-5: DOMA 20012: 00579. Unpublished 

study prepared by Bayer Ag. 46 p.

45865416

(HEC 7155) Acceptable Rainbow Trout

850.1075

Fish Acute 

Toxicity,

Estuarine/Salt

water

Kern, M.; Woodard, D.; Mattern, G. (2002) 

Acute Toxicity of HEC 5725 (Technical) to 

the Sheepshead Minnow (Cyprinodon 

variegatus) Under Static Conditions: Lab 

Project Number: HC830901: 110322. 

Unpublished study prepared by Bayer 

CropScience. 30 p.

45865417

(TGAI) Supplemental No

The solubility limit under the test 

conditions (salt water) were not 

provided; however, the practical 

solubility is expected to be much 

higher than the tested 

concentrations. Sheepshead Minnow

850.1300 Freshwater 

Invertebrate

Life Cycle

Hendel, B. (2000) Influence of HEC 5725 

(tech.) on the Reproduction Rate of Water 

Fleas (Daphnia magna): Lab Project 

Number: E 321 1798-1: HDB/RDM 64. 

Unpublished study prepared by Bayer Ag. 

80 p.

45865418

(TGAI) Acceptable No Daphnia magna
44

OCSPP

Guideline

Data 

Requirement

Test Material

Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data needed 

for risk 

assessment?

Comments

850.1350

Estuarine/

Saltwater 

Invertebrates

Life Cycle

Ward, T.; Wyskiel, D.; Boeri, R. (2002) HEC 

5725: A Flow-Through Life Cycle Toxicity 

Test with the Saltwater Mysid 

(Americamysis bahia): Lab Project Number: 

99-B-132: HC843101: 2359-BR. 

Unpublished study prepared by T.R. 

Wilbury Laboratories, Inc. 48 p.

45865419 

(TGAI) Supplemental No

Salt Water Mysid; following pairing, 

male survival data were not reported; 

second-generation mysids were not 

monitored daily for 4 days for 

survival, development, and behavior, 

and terminal growth measurements 

were not provided by gender

850.1735/ 

OECD 218

Benthic 

Invertebrates 

(Freshwater, 

Prolonged)

Ortego, L. (2006) Fluoxastrobin 

Ecotoxicological Studies - Response to 

Deficiencies. Project Number: HEC082906. 

Unpublished study prepared by Bayer 

CropScience LP. 7 p.

46925805 

(TGAI) na Yes

This is not a study but rather is a 

response to study deficiencies

identified by EPA. The document was 

submitted by the registrant. 

850.1740

Benthic 

Invertebrates 

(Marine, 10-

Day)

Ortego, L. (2006) Fluoxastrobin

Ecotoxicological Studies - Response to 

Deficiencies. Project Number: HEC082906. 

Unpublished study prepared by Bayer 

CropScience LP. 7 p.

46925805

(TGAI) na Yes

This is not a study but rather is a 

response to study deficiencies 

identified by EPA. The document was 

submitted by the registrant.

850.1400

Fish

Early-Life 

Stage, 

Freshwater

Scheerbaum, D. (2001) HEC 5725--Fish 

(Rainbow Trout), Early-Life Stage Toxicity 

Test, Under Flow-Through Conditions: (Final 

Report): Lab Project Number: 991028BD: 

FSR69122. Unpublished study prepared by 

Dr. U. Noack-Laboratorium. 84 p.

45865420

(TGAI) Supplemental No

Rainbow Trout; although reduction in 

time to swim up and increase in yolk 

sacs were observed at statistically 

significant levels, it appears that 

these effects are transient, and in the 

case of time to swim up, not 

dose=dependent. Because no 

treatment-related effects were 

observed in any of the other 

endpoints, a LOAEC values was not 

established. 
45

OCSPP

Guideline

Data 

Requirement

Test Material

Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data needed 

for risk 

assessment?

Comments

850.4400 Aquatic Plant 

Toxicity,

Vascular

Dorgerloh, M. (2001) HEC 5725--Toxicity (7 

Days) to Lemna gibba G3: Lab Project 

Number: E 412 1602-6: DOM 20017: MR238/00. Unpublished study prepared by 

Bayer Ag. 31 p.

45865429 

(TGAI) Acceptable

No

Kern, M.; Lam, C. (2002) Toxicity of HEC 

5725 Technical to Duckweed (Lemna gibba 

G3): Lab Project Number: HC883701: 

200340. Unpublished study prepared by 

Bayer CropScience. 36 p.

45865430

(TGAI) Acceptable

850.4500

Aquatic Plant 

Toxicity,

Algal

Dorgerloh, M. (2000) HEC 5725--Influence 

on the Growth of the Green Alga, 

Selenastrum capricornutum: Lab Project 

Number: E 323 1609-4: DOM 99061. 

Unpublished study prepared by Bayer Ag. 

38 p.

45865431

(TGAI) Acceptable

No

Dorgerloh, M.; Sommer, H. (2001) HEC 

5725--Carboxylic Acid--Influence on the 

Growth of the Green Alga, Selenastrum 

capricornutum: Lab Project Number: E 323 

1878-2: DOM 20061: MR-110/01. 

Unpublished study prepared by Bayer Ag. 

47 p.

45865432

(HEC 7180) Acceptable

Dorgerloh, M. (2000) HEC 5725--

Deschlorophenyl--Influence on the Growth 

of the Green Alga, Selenastrum 

capricornutum: Lab Project Number: E 323 

1756-7: DOM 20015: MR-245/00. 

Unpublished study prepared by Bayer Ag. 

30 p.

45865501 

(HEC 7155) Supplemental

This study was conducted at only one 

concentration (98.8 mg a.i./L; 

solubility note reported) and that 

concentration elicited a reduction in 

cell density which exceeded 10%. The 

test concentration is more 100x 

higher than estimated environmental 

concentrations. 
46

OCSPP

Guideline

Data 

Requirement

Test Material

Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data needed 

for risk 

assessment?

Comments

850.1735

Whole 

Sediment: 

Acute 

Freshwater 

Invertebrates

Thomas, S.; Krueger, H.; Kendall, T. (2012) 

(Carbon 14)-Fluoxastrobin: A 10-Day 

Survival and Growth Toxicity Test with the 

Midge (Chironomus tentans) Using Spiked 

Sediment: Final Report. Project Number: 

443A/147A. Unpublished study prepared by 

Wildlife International Ltd. 72p.

49317701 In Review No

850.1740

Whole 

Sediment: 

Acute Marine 

Invertebrates

Thomas, S.; Krueger, H.; Kendall, T.; et al. 

(2012) (Carbon 14)- Fluoxastrobin: A 10-Day 

Survival Toxicity Test with the Marine 

Amphipod (Leptocheirus plumulosus) Using 

Spiked Sediment: Final Report. Project 

Number: 443A/148. Unpublished study 

prepared by Wildlife International, Ltd. 68p.

49317702 In Review No

850.1770/

850.1760

Whole 

Sediment: 

Chronic 

Invertebrates 

Freshwater 

and Marine

No data Yes

Nonguideline

Development 

and Emergence 

sedimentdwelling 

(Chironomus 

riparius)

Hendel, B. (2000) Influence of HEC 5725 

(tech.) on Developement and Emergence of 

Larvae of Chironomus riparius in a Water 

Sediment System: Lab Project Number: E 

416 1774-0: HDB/CH 41: MR-277/00. 

Unpublished study prepared by Bayer Ag. 

45 p.

45865505

(TGAI) Invalid na

Overlying and pore water 

concentrations were not analyzed at 

every nominal level during the study; 

therefore, the toxicity values do not 

represent actual exposure 

concentrations.
47

OCSPP

Guideline

Data 

Requirement

Test Material

Citation

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data needed 

for risk 

assessment?

Comments

Nonguideline

Chronic Indoor 

Microcosm, 

amphipod

Liebig, M. (2003) A Long-Term Indoor 

Microcosm Study on the Toxicity of 

Fluoxastrobin (EC 100) to the Amphipod 

Gammarus pulex L. in a Natural WaterSediment System. Project Number: P1MG. 

Unpublished study prepared by ECT 

Oekotoxikologie Gmbh. 135 p.

46404901

(TEP) Supplemental na

The results of this study are not 

comparable to the chronic freshwater 

invertebrate studies because 

reproductive endpoints were not 

measured. Concentrations in the 

sediment and pore-water were not 

measured.

NonguidelineMidge Chronic 

Toxicity

Dorgerloh, M.; Sommer, H. (2001) Influence 

of HEC 5725--Carboxylic Acid on 

Development and Emergence of Larvae of 

Chironomus riparius in a Water Sediment 

System: Lab Project Number: E 416 2091-3: 

DOM 21061: 00683. Unpublished study 

prepared by Bayer Ag. 56 p.

45865506

(HEC 7180) Invalid na
48

Table VI.3. Terrestrial Ecological Effects Data for Fluoxastrobin

OCSPP 

Guideline

Data Requirement

Test Material Citation Submitted Studies (MRID) Study Classifications

Are data needed 

for risk 

assessment?

Comments

850.2100 Avian Acute Oral 

Toxicity, bobwhite 

Barfknecht, R. (2000) 

HEC 5725 Techn. Ai: 

Acute Oral Toxicity for 

Bobwhite Quail: Lab 

Project Number: E 292 

1560-5: BAR/LD032. 

Unpublished study 

prepared by Bayer Ag. 38 

p.

45865422 

(TGAI) Acceptable No

No data are available for 

passerine; however, toxicity of 

fluoxastrobin to other avian 

species do not suggest effects 

are likely. 

850.2200 Avian dietary 

toxicity

Barfknecht, R. (2001) 

HEC 5725 Techn.: 5-Day 

Dietary LC50 for 

Bobwhite Quail (Colinus 

virginianus): Lab Project 

Number: E 295 1558-5: 

BAR/LC007. Unpublished 

study prepared by Bayer 

Ag. 34 p.

45865423

(TGAI) Acceptable

Barfknecht, R. (2001) No

HEC 5725 Techn.: 5-Day 

Dietary LC50 for Mallard 

Duck (Anas 

platyrhynchos): Lab 

Project Number: E 297 

1559-8: BAR/LC 009. 

Unpublished study 

prepared by Bayer Ag. 35 

p.

45865424

(TGAI) Acceptable
49

OCSPP 

Guideline

Data Requirement

Test Material Citation Submitted Studies (MRID) Study Classifications

Are data needed 

for risk 

assessment?

Comments

850.2300 Avian reproduction

Frieling, W. (2001) 

Reproduction Study in 

Bobwhite Quail with HEC 

5725 Techn.: (By Dietary 

Admixture): Lab Project 

Number: 259774. 

Unpublished study 

prepared by Notox B.V. 

211 p.

45865425

(TGAI) Acceptable

No

Bowers, L.; Stoughton, T. 

(2003) Effect of 

Technical HEC 5725 on 

Mallard Reproduction: 

Lab Project Number: 

HC740801: 200084. 

Unpublished study 

prepared by Bayer 

CropScience. 129 p.

45865426

(TGAI) Acceptable

Non-guideline Earthworm toxicity, 

Subchronic LC50

Meisner, P. (2000) Acute 

Toxicity of HEC 5725 

Techn. Ai: to Earthworms 

(Eisenia fetida): Lab 

Project Number: E 310 

1771-0: MPE/RG 318/00. 

Unpublished study 

prepared by Bayer Ag. 19 

p.

45865502

(TGAI) Supplemental NA
50

OCSPP 

Guideline

Data Requirement

Test Material Citation Submitted Studies (MRID) Study Classifications

Are data needed 

for risk 

assessment?

Comments

Meisner, P. (2000) Acute 

Toxicity of HEC 5725--

Deschlorophenyl to 

Earthworms (Eisenia 

fetida): Lab Project 

Number: E 310 1759-6: 

MPE/RG 335/00. 

Unpublished study 

prepared by Bayer Ag. 19 

p.

45865503

(HEC 7155) Supplemental

Non-guideline

Earthworm toxicity, 

reproduction and 

growth

Luehrs, U. (2002) HEC 

5725--Deschlorophenyl: 

Effects on Reproduction 

and Growth of 

Earthworms (Eisenia 

fetida) in Artificial Soil: 

Lab Project Number: 

14661022. Unpublished 

study prepared by 

Ibacon GmbH. 36 p.

45865504

(HEC 7155) Supplemental NA

Study type is not typically 

required.

Non-guideline Avian inhalation No data No

Based on STIR analysis, risks 

through inhalation pathway are 

not expected.

870.1100

Acute Mammalian 

Oral

(rat)

Krotlinger, F. (1996) HEC 

5725: Study for Acute 

Oral Toxicity in Rats: Lab 

Project Number: 25231: 

T8060660: 109158. 

Unpublished study 

prepared by Bayer Ag. 29 

p.

45865612 Acceptable No
51

OCSPP 

Guideline

Data Requirement

Test Material Citation Submitted Studies (MRID) Study Classifications

Are data needed 

for risk 

assessment?

Comments

870.3800

Mammalian 

Reproduction

(rat)

Young, A.; Christenson, 

W. (2001) A TwoGeneration Reproductive 

Toxicity Study with HEC 

5725 in the Wistar Rat: 

Lab Project Number: 99-

R72-BW: 110249. 

Unpublished study 

prepared by Bayer 

Corporation and

Pathology Associates 

International. 1473 p.

45865634 (TGAI) Acceptable No

850.3020

Honey Bee Adult 

Acute Oral And 

Contact Toxicity

Bruhnke, C. (2000) HEC 

5725 A.I.--Acute Effects 

on the Honeybee Apis 

mellifera (Hymenoptera, 

Apidae); Limit Test: Lab 

Project Number: 

990222BN: IBA64041. 

Unpublished study 

prepared by NoackLaboratorium. 30 p.

45865427 (TGAI) Acceptable No

Used in place of non-target 

insect testing (880.4350)

850.3030

Honey Bee Toxicity 

Of Residues On 

Foliage

No data No

This study is not triggered 

based on the reported endpoint 

in the honey bee adult acute 

contact study.

Non-guideline

OECD TG 213

Honey Bee Adult 

Acute Oral Toxicity No data No Tier 1 toxicity test. See note above.

Non-guideline 

OECD TG 237

Honey Bee Larvae 

Acute Oral Toxicity No data Yes Tier 1 toxicity test; TGAI
52

OCSPP 

Guideline

Data Requirement

Test Material Citation Submitted Studies (MRID) Study Classifications

Are data needed 

for risk 

assessment?

Comments

Non-guideline Honey Bee Larvae 

Chronic Oral Toxicity No data Yes Tier 1 toxicity test; TGAI

Non-guideline Honey Bee Adult 

Chronic Oral Toxicity No data Yes Tier 1 toxicity test; TGAI

Non-guideline 

OECD 

Guidance 75

Semi-Field Testing 

For Pollinators No data Yes

Tier 2 test contingent on results 

of tier 1 tests and screening 

level residues; TEP

Non-guideline

Field Trial Of 

Residues In Pollen 

and Nectar

No data Yes

Tier 2 test contingent on results 

of tier 1 tests and screening 

level residues; TEP

850.3040 Field Testing For 

Pollinators No data Yes Tier 3 test contingent on results of earlier tiers of testing; TEP

850.4100 Terrestrial Plant 

Toxicity, Seedling 

Emergence

Bowers, L. (2003) Tier 1 

Seedling Emergence and 

Vegetative Vigor 

Nontarget Phytotoxicity 

Study Using HEC 5725 SC 

480: Lab Project 

Number: 200313: 

HC451601: HC451602. 

Unpublished study 

prepared by Bayer 

CropScience. 97 p.

45865428

(TEP) Acceptable

No

48520001

(TEP) Invalid

Study is invalid for lettuce, 

onion, and ryegrass due to poor 

emergence in the controls.
53

OCSPP 

Guideline

Data Requirement

Test Material Citation Submitted Studies (MRID) Study Classifications

Are data needed 

for risk 

assessment?

Comments

Greenland, R. (2011) Tier 

1 Seedling Emergence 

Study Assessing 

Fluoxastrobin 480 SC 

Formulation. Project 

Number: SARS/10/60. 

Unpublished study 

prepared by Stewart 

Agricultural Research 

Services, Inc. 51 p.

Supplemental

Study is supplemental for 

remaining species due to 

excessively high temperature 

during the study that may have 

stressed the plants.

850.4150 Terrestrial Plant 

Toxicity, Vegetative 

Vigor

Greenland, R. (2011) Tier 

1 Vegetative Vigor Study 

Assessing Fluoxastrobin 

480 SC Formulation. 

Project Number: 

SARS/10/61. 

Unpublished study 

prepared by Stewart 

Agricultural Research 

Services, Inc. 51 p.

48520002 (TEP) Acceptable No
54

Bowers, L. (2003) Tier 1 

Seedling Emergence and 

Vegetative Vigor 

Nontarget Phytotoxicity 

Study Using HEC 5725 SC 

480: Lab Project 

Number: 200313: 

HC451601: HC451602. 

Unpublished study 

prepared by Bayer 

CropScience. 97 p.

45865428

(TEP) Acceptable
55

VII. REFERENCES (GENERAL)

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs.

January 23, 2004. Office of Pesticide Programs. Office of Prevention, Pesticides, and Toxic 

Substances. Available at: http://www.epa.gov/espp/consultation/ecorisk-overview.pdf

USEPA. 2014. ECOTOX User Guide: ECOTOXicology Database System. Version 4.0. Available:

http:/www.epa.gov/ecotox/

Bohaty. R, Hetrick, J. Drinking Water Assessment to Support Fluoxastrobin Use on Sweet Cron and Wheat

January 13, 2010 (DP Barcode: 366189)

Bohaty, R. Drinking Water Assessment for Fluoxastrobin Use on Squash/Cucumber (crop subgroup 9B) 

and New In-Furrow and Banded Uses on Tuberous and Corm Vegetables (crop subgroup 1C) as 

well as Peanut December 15, 2010 (DP Barcode: D379114, D384377)

Bohaty, R. Drinking Water Assessment for Fluoxastrobin Use on Melon and Sorghum February 5, 2013

(DP Barcode: D403757)

Bohaty, R. Revised Drinking Water Assessment for fluoxastrobin Use on Rice May 8, 2012 (DP Barcode 

401613)

Nguyen, T., Pease, A. EFED Ecological Risk Assessment for the Section 3 Registration of the New Chemical 

Fluoxastrobin for Uses on Peanuts, Potato and Tuber Vegetables, Leaf Petioles subgroup, Fruiting 

vegetables, Turf, and Seed Treatments for Potato, Peanut, and Turf July 27, 2004 (DP Barcode: 

D289104)

Panger, M. Ecological Risk Assessment for Fluoxastrobin for the Proposed New Use on Melon (Crop 

Subgroup 9a) and Sorghum March 19, 2013 (DP Barcode: D403574)

Panger, M., Bohaty, R., Ecological Risk Assessment for Fluoxastrobin for the Proposed New Use on Rice 

May 8, 2012 (DP Barcode: D392988)

Panger, M., Bohaty, R., Ecological Risk Assessment for Fluoxastrobin for the Proposed New Use on

Squash/Cucumber Subgroup 9B and the Proposed Label Amendment to Add Infurrow and Banded 

Applications for TuberICorm Vegetables and Peanuts January 10, 2011 (DP Barcode: D379112, 

D384375)

Crk, T., Hetrick, J. Ecological Risk Assessment for the Section 3 New Use Registration of Fluoxastrobin on 

new food uses (berry subgroup; field corn and soybean; and, sweet corn and wheat) July 17, 

2009 (DP Barcode: D356983, D357729, D366187)

Shanaman, Lucy, Frankenberry, M. Section 3 Registration for Proposed New Use of Fluoxastrobin on 

Ornamental Plants August 29, 2008 (DP Barcode: D349270, D349282)
56

APPENDIX A. CHEMICAL IDENTIFICATION OF FLUOXASTROBIN TRANSFORMATION PRODUCTS

Company Code

Major/ Minor 

Transformation 

Product

Study Observed Chemical Structure

HEC 5725-oxazepine Major Aquatic Photolysis

MRIDs 45865306, 45865403

HEC 7339 

HEC 5725-phenoxy-aminopyrimidine

Minor Aquatic Photolysis

MRIDs 45865306, 45865403

HEC 7155,

HEC5725-E-deschlorophenyl

Major

Aerobic Soil Metabolism

MRIDs 45865309, 45865310

Aerobic Aquatic Metabolism

MRID 45865313

HEC 7180,

HEC5725-carboxylic acid

Minor

Aerobic Soil Metabolism

MRIDs 45865309, 45865310

Aerobic Aquatic Metabolism

MRID 45865313

HEC5725-E-4-

hydroxyphenyl Minor Aerobic Soil Metabolism

MRIDs 45865309, 45865310

HEC 7334 Minor Aerobic Aquatic Metabolism

MRID 45865313
57

Company Code

Major/ Minor 

Transformation 

Product

Study Observed Chemical Structure

HEC 7338

HEC 5725-amide Minor Aerobic Aquatic Metabolism

MRID 45865313
58

APPENDIX B. SIP ANALYSIS RESULTS

 

Table B.1. SIP Inputs (solubility at 

20  ̊C at pH 7 of 2.292 mg/L)

Parameter Value

Chemical name Fluoxastrobin

Solubility (in water at 25oC; mg/L) 2.559

Mammalian LD50 (mg/kg-bw) 2000

Mammalian test species laboratory rat

Body weight (g) of "other" 

mammalian species

Mammalian NOAEL (mg/kg-bw) 70

Mammalian test species laboratory rat

Body weight (g) of "other" 

mammalian species

Avian LD50 (mg/kg-bw) 461

Avian test species mallard duck

Body weight (g) of "other" avian 

species

Mineau scaling factor

Mallard NOAEC (mg/kg-diet) 590

Bobwhite quail NOAEC (mg/kgdiet) 1029

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
59

Table 2. Mammalian Results

Parameter Acute Chronic

Upper bound exposure (mg/kg-bw) 0.4401 0.4401

Adjusted toxicity value (mg/kg-bw) 1538.3211 53.8412

Ratio of exposure to toxicity 0.0003 0.0082

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) 2.0728 2.0728

Adjusted toxicity value (mg/kg-bw) 36419.0000 29.2714

Ratio of exposure to acute toxicity 0.0001 0.0708

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.
60

APPENDIX C. STIR ANALYSIS RESULTS

The Screening Tool for Inhalation Risk (STIR v.1.0, November 19, 2010) was used to calculate an upper 

bound estimate of exposure using fluoxastrobin’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 that 

are submitted to the Registration Division of the Office of Pesticide Programs for technical and 

formulated products of a pesticide [acute oral LD50 >2,000 mg a.i./kg-bw, rat (MRID 45902118); acute 

inhalation LC50 > 5.05 mg/L, rat (MRID 45902124)] as well as the most sensitive acute oral avian toxicity 

endpoint [LD50 > 2,000 mg a.i./kg-bw, bobwhite quail (MRID 45902309)]. Based on the results of the 

STIR model, inhalation exposure alone was not determined to be a potential pathway of concern for 

avian or mammalian species on an acute basis for either ground or aerial spray types. Detailed 

information about STIR v.1.0, as well as the tool, can be found on the EPA’s website at: 

http://www.epa.gov/pesticides/science/models_pg.htm#terrestrial. 

Input

Application and Chemical 

Information

Enter Chemical Name Fluoxastrobin

Enter Chemical Use

Is the Application a Spray? (enter y 

or n) y

If Spray What Type (enter ground or 

air) ground

Enter Chemical Molecular Weight 

(g/mole) 458.83

Enter Chemical Vapor Pressure 

(mmHg) 4.12E-12

Enter Application Rate (lb a.i./acre) 2

Toxicity Properties

Bird

Enter Lowest Bird Oral LD50 (mg/kg 

bw) 2000

Enter Mineau Scaling Factor 1.15

Enter Tested Bird Weight (kg) 0.178

Mammal

Enter Lowest Rat Oral LD50 (mg/kg 

bw) 2000

Enter Lowest Rat Inhalation LC50

(mg/L) 4.9

Duration of Rat Inhalation Study 

(hrs) 4

Enter Rat Weight (kg) 0.35

**NOTE**: When entering values, 

press the "Enter" key in order to 

update linked cells.
61

Output

Results Avian (0.020 kg )

Maximum Vapor Concentration in Air 

at Saturation (mg/m3) 1.02E-07

Maximum 1-hour Vapor Inhalation 

Dose (mg/kg) 1.28E-08

Adjusted Inhalation LD50 2.73E+01

Ratio of Vapor Dose to Adjusted 

Inhalation LD50 4.68E-10 Exposure not Likely Significant

Maximum Post-treatment Spray 

Inhalation Dose (mg/kg) 2.11E-01

Ratio of Droplet Inhalation Dose to 

Adjusted Inhalation LD50 7.74E-03 Exposure not Likely Significant

Results Mammalian (0.015 

kg )

Maximum Vapor Concentration in Air 

at Saturation (mg/m3) 1.02E-07

Maximum 1-hour Vapor Inhalation 

Dose (mg/kg) 1.61E-08

Adjusted Inhalation LD50 2.92E+02

Ratio of Vapor Dose to Adjusted 

Inhalation LD50 5.51E-11 Exposure not Likely Significant

Maximum Post-treatment Spray 

Inhalation Dose (mg/kg) 2.66E-01

Ratio of Droplet Inhalation Dose to 

Adjusted Inhalation LD50 9.11E-04 Exposure not Likely Significant