Baseline Ecological Risk Assessment for the 

New Active Ingredient - Flutriafol

IUPAC Chemical Name: 

RS)-2,4'-difluoro-a-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol

CAS Chemical Name: 

α-(2-Fluorophenyl)-α-(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol

CAS Number: 76674-21-0

PC Code: 128940

Prepared by:

U. S. Environmental Protection Agency

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch III

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460

Stephen Carey, Biologist

Lucy Shanaman, Chemist

Stephanie Syslo, Environmental Scientist/RAPL

Reviewed by:

Mary Frankenberry, Statistician

Brian Anderson, Biologist

Mark Corbin, Senior Environmental Scientist

Jim Hetrick, Senior Environmental Scientist

N

N N C

H2

OH

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2

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY.......................................................................... 5

II. PROBLEM FORMULATION........................................................................ 18

A. NATURE OF REGULATORY ACTION...................................................... 18

B. STRESSOR SOURCE AND DISTRIBUTION.............................................. 18

1. Nature of the Chemical Stressor...................................................... 18

2. Overview of Pesticide Usage............................................................ 20

C. RECEPTORS....................................................................................... 20

1. Aquatic Effects............................................................................ 21

2. Terrestrial Effects........................................................................ 21

3. Ecosystem at Risk......................................................................... 23

D. ASSESSMENT ENDPOINTS................................................................... 23

E. CONCEPTUAL MODEL........................................................................ 24

1. Risk Hypothesis........................................................................... 24

2. Conceptual Model........................................................................ 24

F. ANALYSIS PLAN........................................................................... 27

1. Preliminary Identification of Data Gaps and Methods.......................... 27

2. Measures of Effects and Exposure................................................... 28

a. Measures of Exposure......................................................... 28

b. Measures of Effects............................................................ 29

III. ANALYSIS.............................................................................................. 31

A. USE CHARACTERIZATION................................................................. 31

B. EXPOSURE CHARACTERIZATION ...................................................... 32

1. Environmental Fate and Transportation Characterization...................... 32

a. Summary of Environmental Fate of Flutriafol........................... 32

b. Persistence and Transformation............................................ 33

c. Transport and Mobility...................................................... 34

d. Field Studies.................................................................... 35

2. Measures of Aquatic Exposure........................................................ 35

a. Aquatic Exposure Modeling................................................. 35

b. Modeling Results................................................................................... 36

c. Aquatic Exposure Monitoring and Field Data........................... 37

3. Measures of Terrestrial Exposure.................................................... 37
3

a. Terrestrial Exposure Modeling for Spray Applications............... 37

 4. Measures of Incidental Spray Drift Exposure................................................. 41

C. ECOLOGICAL EFFECTS CHARACTERIZATION ................................... 42

1. Aquatic Effects Characterization..................................................... 43

2. Terrestrial Effects Characterization................................................. 51

IV. RISK CHARACTERIZATION.......................................................................... 57

A. RISK ESTIMATION – INTEGRATION OF EXPOSURE AND 

 EFFECTS DATA................................................................................... 58

1. Non-target Aquatic Animals and Plants............................................ 60

a. Fish .............................................................................. 62

b. Invertebrates................................................................... 64

c. Aquatic Plants.................................................................. 65

d. Aquatic-phase Amphibians.................................................................. 67

2. Non-target Terrestrial Animals...................................................... 67

a. Birds........................................................................... 67

b. Mammals........................................................................ 71

c. Terrestrial-phase Amphibians and Reptiles....................................... 74

d. Beneficial Insects................................................................................... 74

3. Non-target Terrestrial Plants in Terrestrial and Semi-aquatic 

Environments............................................................................... 74

B. RISK DESCRIPTION............................................................................. 75

1. Risks to Aquatic Animals and Plants.................................................... 77

a. Aquatic Animals............................................................... 77

b. Aquatic Plants ................................................................ 80

c. Aquatic-phase Amphibians................................................................. 82

2. Risks to Non-target Terrestrial Animals and Plants.............................. 82

a. Terrestrial Animals............................................................. 82

b. Terrestrial Plants................................................................ 88

 c. Terrestrial-phase Amphibians and Reptiles....................................... 88

 d. Beneficial Insects................................................................................... 88

3. Review of Incident Data................................................................. 89

4. Endocrine Effects........................................................................ 89

5. Federally Threatened and Endangered (Listed) Species Concerns............ 89

a. Action Area........................................................................ 89

b. Taxonomic Groups Potentially at Risk..................................... 90

1. Discussion of Risk Quotients..................................... 91

2. Probit Dose Response Relationship............................ 92

3. Data Related to Under-represented............................ 94

4. Implications of Sub-lethal Effects.............................. 94

c. Indirect Effects Analysis...................................................... 94

d. Critical Habitat.................................................................. 94

e. Direct Effect Co-occurrence Analysis...................................... 95

f. Indirect Effect Co-occurrence Analysis..................................... 96
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C. ASSUMPTIONS, UNCERTAINTIES, STRENGTHS AND LIMITATIONS OF 

THE FLUTRIAFOL ASSESSMENT....................................................... 97

REFERENCES................................................................................................................................. 101

APPENDICES

Appendix A.

 Environmental Fate Assessment and Data Summary ...................................... 102

Appendix B.

Aquatic Exposure Modeling and Results (GENEEC2 and PRZM/EXAMs) ......... 137

Appendix C.

Aquatic Risk Quotients........................................................................... 147

Appendix D.

Terrestrial Birds and Mammals Exposure Modeling and Results (TREX v1.3.1) ... 150

Appendix E.

Terrestrial Plants Exposure Modeling and Results (TerrPlant v 1.2.2) ................. 172

Appendix F.

Ecological Effects Data............................................................................. 175

Appendix G.

Flutriafol Ecological Effects Bibliography..................................................... 203

Appendix H.

Flutriafol Environmental Fate Bibliography................................................................. 208

Appendix I.

Direct Effects Endangered Species Analysis for Apples...............................................

Compact 

Disc

Appendix J.

Indirect Effects Endangered Species Analysis for Apples.....................................

Compact 

Disc

Appendix K.

Direct Effects Endangered Species Analysis for Soybeans....................................... Compact 

Disc

Appendix L. 

Indirect Effects Endangered Species Analysis for Soybeans........................................ Compact 

Disc

Appendix M. 

PRZM Input File for Runoff, Erosion, Leaching Assessment...................................... 214

FIGURES AND GRAPHS

Figure 1. 

Flutriafol .............................................................................................. 19

Figure 2.

Flutriafol Environmental Risk Conceptual Model ........................................... 26

Figure 3.

Time Series of Flutriafol Concentrations in Surface Soil (10 cm depth) for the MS 

Soybean Scenario..................................................................................... 34

Graph IV-1.

Number of Applications Required to Exceed the LOC of 1 for Adverse Effects of 

Growth and Reproduction to Birds ................................................................................ 92
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I. EXECUTIVE SUMMARY

A. Nature of the Chemical Stressor

The new active ingredient, flutriafol ((RS)-2,4'-difluoro-a-(1H-1,2,4-triazol-1-

ylmethyl)benzhydryl alcohol); CAS Reg No. 4787-LL) is a triazole derivative used as a systemic 

fungicide. Flutriafol belongs to a group of demethylation inhibitors (DMI fungicides). While 

testing for this chiral compound was conducted on the racemic mixture, no data are available for 

either of the resolved isomers, and only one of the minor degradates forming in the laboratory

studies retained a chiral center. The mode of action for this conazole fungicide, flutriafol, is as a 

sterol biosynthesis inhibitor (SBI) that inhibits microsomal sterol demethylation in membranes. 

Common with all other DMI fungicides, flutriafol has a nitrogen atom that attaches to the center 

of an iron group within the cytochrome, which prevents or blocks the formation of ergosterol 

during demethylation. For a conozole fungicide, the triazol moiety of toxicological concern is 

expected as a degradation product. There were no major degradation products reported in any 

studies submitted in support of this registration. Flutriafol degraded with half-lives greater than 

a year in most environmental compartments. 

There is one proposed product for flutriafol: TOPGUARDTM Fungicide (EPA Reg. No. 67760-

TL), also known as Flutriafol 125 g/L SC. It is used to control scab, powdery mildew, and quince 

and cedar apple rust on apples and soybean rust, frogeye leaf spot, cercospora blight and leaf 

spot, brown spot, powdery mildew on soybeans. TOPGUARDTM Fungicide (11.8% ai) is a

soluble concentrate containing 1.04 pound per gallon of the active ingredient flutriafol that can 

be diluted with water. It is worthwhile to note that a comparison of the available formulated

product (TOPGUARD fungicide) and flutriafol technical toxicity data shows that the formulated

product (TOPGUARD fungicide), when values are expressed in terms of the active ingredient, is

approximately 30 to 50-fold more toxic than the active ingredient in an aquatic environment. 

B. Potential Risk to Non-target Animals and Plants

The Agency’s Levels of Concern (LOCs) for potential risk to animals and plants is determined 

when a RQ exceeds one or more of the following risk presumption categories. When there is a 

LOC exceedance, it indicates that a pesticide used as directed has the potential to cause adverse 

effects on non-target wildlife. LOCs currently address the following risk presumption 

categories: (1) acute risk – when a RQ is equal to or greater than the LOC of 0.5 to animals, (2) 

acute restricted use – when a RQ is equal to or greater than the LOC of 0.2 and 0.1 for 

terrestrial and aquatic animals, respectively, (3) acute endangered species – when a RQ is equal 

to or greater than the LOC of 0.1 and 0.05 for terrestrial and aquatic animals, respectively, (4) 

chronic risk – when a RQ is equal to or greater than the LOC of 1.0 to animals, and (5) nonlisted and listed plant risk - when a RQ is equal to or greater than the LOC of 1.0 to plants. 

Table I-1 presents the RQs for terrestrial and aquatic animals and plants exposed to flutriafol 

and its formulated product (Flutriafol 125 g/L). 
6

Table I-1. Summary of Risk Quotient Calculations for Flutriafol and Flutriafol 125 g/L SC

Exposures to Terrestrial and Aquatic Animals and Plants.*

Species Flutriafol RQs Flutriafol 125 g/L SC 

RQs Exposure Model Used

Aquatic Animals and Plants

Freshwater Fish Acute RQs: <0.01

Chronic RQs: <0.1 Acute RQs: <0.01

GENEEC2

Estuarine/marine Fish Acute RQs: <0.01

Chronic RQs: <0.1 Acute RQs: <0.01

Freshwater Invertebrates Acute RQs: <0.01

Chronic RQs: <0.1 Acute RQs: <0.01

Estuarine/marine 

Invertebrates

Acute RQs: <0.01

Chronic RQs: <0.1 Acute RQs: <0.01

Aquatic Vascular Plants Non-listed RQs: <0.1

Listed RQs: <0.1 – 0.6

Aquatic Non-Vascular 

Plants

Non-listed RQs: <0.1

Listed RQs: <0.1 -- 0.1

Terrestrial Animals and Plants

Birds Acute RQs: <0.01 – 0.25

Chronic RQs: <0.1 – 2.2

--

T-REX Mammals Acute RQs: <0.01 – 0.4

Chronic RQs: <0.1 – 1.8 Acute RQs: <0.01

Terrestrial Monocots Non-listed RQs: <0.1

Listed RQs: <0.1 TERRPLANT Terrestrial Dicots Non-listed RQs: <0.1

Listed RQs: <0.1

* Values in bold are LOC exceedances

Tables I-2 and I-3 provide a summary of the environmental risk conclusions of the active 

ingredient (AI) to aquatic and terrestrial animals and plants, respectively, from proposed use 

patterns for apples and soybeans. The environmental risk conclusions for the AI are based on the 

most sensitive toxicity endpoints and maximum use scenarios. Details of the environmental risk 

conclusions for the AI can be found in the Risk Description section (Section IV.B).

Table I-2. Flutriafol (AI): Summary of Environmental Risk Conclusions for Aquatic Animals & 

Plants 

Assessment Endpoint Use Patterns with LOC 

Exceedances

Summarized Risk Characterization

Acute and Chronic Risk to 

Freshwater Fish (and 

Aquatic-phase Amphibians) 

and Invertebrates.

None

No acute or chronic LOC exceedances for freshwater 

fish, aquatic-phase amphibian, and invertebrate

species exposed to the AI. 

Acute and Chronic Risk to 

Estuarine/Marine Fish and 

Invertebrates 

None

No acute LOC exceedances for estuarine/marine fish 

and invertebrate species exposed to the AI. Due to 

lack of chronic toxicity data, the risks are uncertain. 

However, there are no chronic LOC exceedances 

using estimated NOAECs.

Risk to Aquatic Vascular 

and Non-vascular Plants None

There are no LOC exceedances for non-listed and 

listed aquatic plants (both vascular and nonvascular)

exposed to the AI.
7

Table I-3. Flutriafol (AI): Summary of Environmental Risk Conclusions for Terrestrial Animals and 

Plants

Risk Conclusion Use Patterns with LOC 

Exceedances

Summarized Risk Characterization

Acute Risk to Birds 

(including terrestrialphase amphibians and 

reptiles) 

Apple: Two or more 

applications, the acute 

endangered LOC is exceeded 

for small-sized birds. At 4 or 

more applications, the LOC is 

exceeded for medium-sized

birds.

Soybean: No LOC exceedance 

for one or two applications. At 

the maximum number of 

applications (3) with 14-day

intervals, the acute endangered 

LOC is exceeded. If the 

reapplication interval is 

increased to 21 days from 14 

days, there are no acute LOC 

exceedances.

Apple: The acute restricted use and acute endangered

LOCs are exceeded for small- and medium-sized birds 

foraging on the assessed food items except fruits, 

pods, large insects, and seeds. There are no acute LOC 

exceedances for large-sized birds (1000g). Small-sized 

(20g) birds and medium-sized (100g) birds (including 

terrestrial-phase amphibians and reptiles) foraging in 

or near an apple site with two applications or more 

would be at risk for adverse effects on survival as a 

result of exposure to the AI.

Soybean (3 times @ 0.06 lb ai/A with 14-day

interval): The acute endangered LOC is exceeded for 

small-sized birds feeding on short grass. No acute 

LOC exceedances for 100 g and 1000 g birds, reptiles, 

and terrestrial-phase amphibians exposed to flutriafol 

technical. Small-sized birds feeding in or near a 

soybean field would be at risk for adverse effects on 

survival as a result of exposure to the AI.

Soybean (3 times @ 0.06 lb ai/A with 21-day

interval): There are no acute LOC exceedances for any 

birds of any weight classes exposed to the AI.

Chronic Risk to Birds 

(including terrestrialphase amphibians and 

reptiles) 

Apple: Two or more 

applications, the acute 

endangered LOC is exceeded 

for birds feeding on short 

grass. At 3 or more 

applications, the LOC is 

exceeded for birds feeding on 

broadleaf plants and small 

insects. It requires 4 or more 

applications for potential risk 

to birds feeding on tall grass.

Apple: The chronic risk LOC is exceeded for birds 

foraging short grass, tall grass, broadleaf plants and 

small insects following flutriafol applications to 

apples. Birds of all weight classes (including 

terrestrial-phase amphibians and reptiles) foraging 

food items with flutriafol residues in or near an apple

site with two applications or more would be at risk for 

adverse effects on growth and reproduction as a result 

of exposure to the AI.

Soybean: No chronic LOC exceedances for birds of all 

weight classes, including terrestrial-phase amphibians 

and reptiles exposed to the AI. 

Acute Risk to Mammals

Apple: One or more 

application(s), the acute 

endangered LOC is exceeded 

for small- and medium-sized 

mammals, two or more

applications to exceed the LOC 

for large-sized mammals. 

Soybean: No exceedance for 

one application. At 2 or more 

applications, the acute 

endangered LOC is exceeded 

Apple: The acute risk, acute restricted use, and acute 

endangered LOCs are exceeded for all weight classes 

(15g, 35g, 1000g) of mammals foraging on the 

assessed food items except fruits, pods, large insects, 

and seeds. The 15g, 35g, 1000g mammals foraging in 

or near an apple site would be at risk for adverse 

effects on survival as a result of exposure to AI.

Soybean (3 times @ 0.06 lb ai/A with either a 14-day

or 21-day interval): The acute restricted and acute 

endangered LOCs are exceeded for 15 g and 35 g 

mammals feeding on short grass. There are no acute 

LOC exceedances for 1000 g mammals or for 15 and 
8

Table I-3. Flutriafol (AI): Summary of Environmental Risk Conclusions for Terrestrial Animals and 

Plants

Risk Conclusion Use Patterns with LOC 

Exceedances

Summarized Risk Characterization

for some mammals. 35 g mammals that feed on tall grass, broadleaf plants, 

insects, and seeds. The 15g and 35g mammals 

foraging on short grass in or near a soybean field 

would be at risk for adverse effects on survival as a 

result of exposure to the AI.

Chronic Risk to Mammals

Apple: No exceedance for two 

applications. At 3 or more 

applications, the acute 

endangered LOC is exceeded 

for small and medium sized

mammals. 

Apple: The chronic risk LOC is exceeded for 15g 

mammals foraging short grass, tall grass, broadleaf 

plants and small insects, for 35g mammals foraging 

short grass, broadleaf plants, and small insects, and 

1000g mammals foraging short grass following 

flutriafol applications to apples. All weight classes of

mammals feeding on short grass and some feeding on 

tall grass, broadleaf plants and small insects in or near 

an apple field would be at risk for adverse effects on 

reproduction and growth as a result of exposure to the 

AI.

Soybean: No chronic LOC exceedances for mammals 

of all weight classes exposed to the AI.

Risk to Beneficial Insects None

Available honeybee toxicity data indicate that 

flutriafol technical is practically non-toxic to 

honeybees from direct treatment; therefore, 

precautionary label language to protect bees from

flutriafol exposures is not required.

Risk to Terrestrial Plants None

No listed or non-listed LOC exceedances for terrestrial 

monocots and dicots exposed to the AI via runoff and 

spray drift following one application to apple or 

soybean. 

The formulated product of flutriafol (Flutriafol 125 g/L SC) has been shown to be more toxic to 

aquatic animals than the technical grade active ingredient. The risks to the formulated product 

must be assessed rather than just those to the active ingredient. 

For this assessment with the formulated product as a whole, the product toxicity values were 

compared to AgDRIFT exposure concentrations for any potential risks to aquatic animals. 

AgDRIFT exposure concentrations for the formulation are derived by assuming that the 

agriculturally applied formulation immediately reaches adjacent non-target sites through spray

drift. The model, AgDRIFT, only estimates spray drift (or ‘acute’) exposure concentrations; 

chronic exposure estimations (from runoff or spray drift) are not possible for the formulated 

product, Flutriafol 125 g/L SC, and the risks from chronic exposure (from runoff or spray drift)

to aquatic animals based on the product toxicity values (mg form/L) are therefore not included in 

this assessment. 

Tables I-4 and I-5 provide a summary of the environmental risk conclusions of the formulated 

product as a whole (based on the combination of the AI and inerts, the “product toxicity values”) 

to terrestrial and aquatic animals and plants, respectively. Details of the environmental risk 
9

conclusions for the formulation can be found in the Risk Description section (Section IV.B).

Table I-4. Flutriafol Formulated Product: Summary of Environmental Risk Conclusions for 

Terrestrial Animals & Plants 

Assessment Endpoint Use Patterns with LOC 

Exceedances

Summarized Risk Characterization

Acute Risks to Mammals None

For the formulated product, there are no acute LOC 

exceedances for mammals exposed to the formulated

product following one application to soybean or apple. 

Risk to Terrestrial Plants None

No listed or non-listed LOC exceedances for terrestrial 

monocots and dicots exposed to the formulated product 

via spray drift following one application to apple or 

soybean.

Table I-5. Flutriafol Formulated Product: Summary of Environmental Risk Conclusions for Aquatic

Animals & Plants 

Assessment Endpoint Use Patterns with LOC 

Exceedances

Summarized Risk Characterization

Acute Risks to Freshwater 

and Estuarine/marine Fish None

No acute LOC exceedances for freshwater and 

estuarine/marine fish exposed to the formulated product via 

spray drift following one application of flutriafol 125 g/L 

SC to soybean and apple.

Acute Risk to Freshwater 

Invertebrates None

No acute LOC exceedances for freshwater invertebrates 

exposed to the formulated product via spray drift following

one application of flutriafol 125 g/L SC to soybean and 

apple.

Acute Risk to 

Estuarine/marine 

Invertebrates 

None

There are no acute LOC exceedances for estuarine/marine 

invertebrates adjacent to apple and soybean sites exposed 

to the product via spray drift following one application. 

Risk to Aquatic Vascular 

and Non-vascular Plants None

No listed or non-listed LOC exceedances for aquatic plants, 

both vascular and nonvascular, exposed to the formulated 

product via spray drift following one application.

C. Exposure Characterization

Flutriafol is a fungicide that is expected to be persistent and moderately mobile in the 

environment. Because leaching, runoff, erosion, and accumulation in soil are possible processes 

controlling the environmental fate of flutriafol, PRZM modeling was conducted to assess the 

contribution of each process in controlling the environmental fate of flutriafol under field 

conditions. PRZM modeling predicted that the dominant route of dissipation for flutriafol is 

leaching below the root zone; the contributions from runoff and erosion were much less. 

Results from non-guideline field dissipation studies showed that following multiple applications 

over a number of years, flutriafol residues were found in the soil to the maximum depth sampled. 
10

However, no field data quantifying the maximum depth of leaching under actual use conditions 

have been provided. As a result, the combination of modeling predictions and field observations 

of leaching would indicate a potential for flutriafol to contaminate ground water. 

Although PRZM modeling results did not indicate that accumulation in soil was the controlling 

dissipation process, modeled flutriafol concentrations in soil remained steady at an elevated level 

for the duration of the simulation. This is consistent with both the laboratory data (half-lives of 

more than one year in aerobic soil) and data from the same terrestrial field dissipation studies 

mentioned above which showed flutriafol accumulation with repeated applications.

Although no major degradation products of flutriafol have been identified in the fate studies, 

1,2,4-triazole has been identified as a minor degradate in the submitted fate studies, and has been 

determined to be a human health concern by the OPP Health Effects Division (HED). 1,2,4-

Triazole is a common degradate of all conazole pesticides and its fate properties and toxicity will 

be addressed by the Agency1in a separate assessment at a later date and are not included in this 

assessment. 

Estimated environmental concentrations (EECs) in water are estimated using the Tier I model 

GENEEC2 (Version 2.0; August 1, 2001), which simulates exposure in a standard pond of the 

active ingredient to aquatic species resulting from deposition, runoff, and spray drift. Based on 

the labeled information to control apple scab on apples at a maximum application rate of 0.11 lb 

a.i./A, applied 4 times at 7 day intervals, the maximum model predicted peak, 21-day, and 60-

day GENEEC EECs are 0.021 mg a.i./L, 0.021 mg a.i./L, and 0.021 mg a.i./L, respectively. 

Because the RQs for listed aquatic vascular plants exceeded the level of concern of 1.0 with the 

generic Tier I EECs, the Tier II model PRZM (Version 3.12.2)/EXAMS (Version 2.98.04) was 

used to estimate the surface water EECs from different geographical locations. To control apple 

scab on North Carolina apples, the maximum model predicted peak, 21-day, and 60-day

PRZM/EXAMs EECs are 0.01 mg a.i./L, 0.0091 mg a.i./L, and 0.008 mg a.i./L, respectively.

Terrestrial exposure to birds and mammals are considered using the T-REX (Ver.1.3.1) model to 

estimate residues on food types as the result of flutriafol application. Based on the maximum 

labeled application rate for apples (0.11 lbs ai/A), applied 4 times at 7-day intervals was used to

predicted the highest dietary-based residue for the assessed food items that could be foraged by 

the animals. The EECs for short grass, tall grass, broadleaf forage/small insects, and seeds/large 

insects are 86.8 mg ai/kg, 39.8 mg ai/kg, 48.8 mg ai/kg, and 5.4 mg ai/kg, respectively. EECs

based on maximum application rates for non-target terrestrial plants are estimated using the 

TerrPlant (Ver 1.3.1) model in this risk assessment.

Exposure estimates from off-site spray drift to areas adjacent to treated areas were generated

using the AgDRIFT model (Ver 2.0.1). Quantitative exposure modeling for formulations is 

based on the expectation that the varying physical-chemical properties of individual components 

will control the environmental fate of the formulated product. Thus, it is not possible to calculate 

acute or chronic exposure estimates to aquatic animals and plants via runoff or chronic exposure 

estimates to any of these taxa via spray drift since it is unlikely that the components of the 

 

1

http://www.epa.gov/opprd001/factsheets/tetraHHRA.pdf
11

formulation will drift or runoff to these non-target areas together as an unit after repeated 

applications.

 

D. Effects Characterization

Aquatic Effects 

Available acute toxicity data for aquatic animals (freshwater, estuarine and marine) indicate the 

AI is no more than slightly toxic to fish and is slightly toxic to invertebrates. Chronic effects for

the AI are reduced post-hatch survival of freshwater fish at 9.5 mg ai/L; the NOAEC is 4.8 mg 

ai/L. Significant effects on reproduction and growth in freshwater invertebrates were observed at 

a range of NOAEC values of 0.31 mg ai/L to 1.0 mg ai/L for the active ingredient. 

Chronic toxicity of the AI to estuarine/marine animals is not available. Acute to chronic ratio 

(ACR) values were derived from different fish or invertebrate species to estimate the 

estuarine/marine fish and invertebrate NOAECs. The estimated NOAECs for estuarine/marine 

fish and invertebrates exposed to the AI are >11 mg ai/L and 0.013 mg ai/L, respectively. 

Comparison of toxicity studies using the AI and the formulation blank group in its formulated 

product studies suggests the toxicity of one or more inert (inactive) ingredients is considerably 

higher in aquatic environments than the toxicity of the active ingredient. 

The LC50 and EC50 for freshwater fish and invertebrates exposed to the formulated product 

(Flutriafol 125 g/L SC) are 7.6 mg form/L and 6.8 mg form/L, respectively. The formulated 

product caused reproductive effects in freshwater invertebrates as low as 0.33 mg form/L; the 

NOAEC is 0.1 mg form/L.

The acute toxicity of the formulated product (Flutriafol 125 g/L SC) to estuarine/marine animals 

was not available. Therefore, acute to acute ratio (AAR) values were used to estimate the 

estuarine/marine fish and invertebrate acute toxicity values for the formulated product. The

estimated LC50 and EC50 for estuarine/marine fish and invertebrates exposed to the formulated

product are >16.5 mg form/L and 2.5 mg form/L, respectively. 

Exposure to the formulated product resulted in growth inhibition of cell density in marine 

diatoms (aquatic non-vascular plants), with the lowest EC50 of 0.46 mg ai/L (NOAEC = 0.1 mg 

ai/L). For duckweed, the EC50 for the formulated product is 0.78 mg ai/L (NOAEC <0.13 mg 

ai/L; EC05 = 0.018 mg ai/L). 

Terrestrial Effects

Available acute toxicity data indicate that the AI is slightly toxic to practically nontoxic to 

upland game birds and waterfowl via oral gavage and subacute dietary routes. No acute oral 

toxicity data are available for a passerine bird tested with the AI. Available toxicity data with 

upland game bird and waterfowl suggest flutriafol could be toxic to passerine birds. Chronic 

studies for the AI show reproductive effects of reduced hatchability in upland game birds and 

waterfowl at 95 and 97.5 mg ai/kg diet, respectively. The avian NOAECs are <95 and 39.2 mg

ai/kg diet, respectively. 
12

Acute toxicity data indicate the AI is moderately to slightly toxic to mammals. Results of the 2-

generation study with the AI indicate reproductive effects with a reduction in parent body weight 

gains, effects on the liver, litter size and fertility index observed at 1000 mg ai/kg diet (males 

88.7 mg ai/kg bw/day; females 103 mg ai/kg bw/day) with a corresponding NOAEC of 240 mg

ai/kg diet (males 20.6 mg ai/kg bw/day; females 21.9 mg ai/kg bw/day). 

Available Flutriafol 125 g/L SC toxicity data indicate the product is not toxic to mammals (LD50

>2000 mg form/kg-bw). 

Acute contact honeybee studies indicate that flutriafol and its formulated products are practically

nontoxic to honeybees. 

Terrestrial plant toxicity studies with monocots and dicots indicate the formulated product of 

flutriafol did not cause 25% inhibition at the limit dose of 0.12 lbs ai/A. 

E. Endangered (Listed) Species

As shown in Table I-6, this ecological risk assessment for use of flutriafol on soybeans and 

apples indicates direct effects LOCs exceedances for birds, terrestrial-phase amphibians, reptiles,

and mammals. Therefore, there is potential for indirect effects to all listed terrestrial animal and 

plant taxa that depend on those animals as pollinators or seed dispersers, mammal or reptile 

burrows for habitat, feeding, or cover requirements, and for survival, growth, or reproduction. 

The listed animal and plant species that reside in areas where flutriafol may be used are

summarized in appendices J and K for apples and appendices L and M for soybeans.

Table I-6. Listed Taxonomic Groups Potentially at Risk for Direct or Indirect Effects as a Result of Flutriafol 

Applications (Applications are for Terrestrial Outdoor Uses where Apples and Soybeans are grown 

Nationwide). 

Listed Taxon Direct 

Effects

Uses of Direct Effects 

Concern

Indirect 

Effects

Uses of Indirect Effects 

Concern

Terrestrial and SemiAquatic Plants – monocots No None Yes3,4 Apple and Soybean

Terrestrial and SemiAquatic Plants -- dicots No None Yes3,4 Apple and Soybean

Terrestrial Invertebrates No None Yes3,4 Apple and Soybean

Birds and Reptiles1 Yes Apple and Soybean6 Yes3,4 Apple and Soybean

Terrestrial-phase 

Amphibians1 Yes Apple and Soybean6 Yes3,4 Apple and Soybean

Mammals Yes Apple and Soybean5 Yes3,4 Apple and Soybean

Aquatic Vascular Plants No Apple Yes3,4 Apple and Soybean

Freshwater Fish and 

Aquatic-phase Amphibians2 No None None None

Freshwater Invertebrates No None None None

Estuarine/marine Fish No None None None

Estuarine/marine No None None None
13

Invertebrates

Aquatic Nonvascular Plants No None Yes3,4 Apple and Soybean

1 Birds are used as surrogate species for terrestrial-phase amphibians and reptiles; therefore, potential direct and 

indirect effects to endangered avian, terrestrial-phase amphibians and reptilian species are considered equivalent.

2 Fish are used as a surrogate for aquatic phase amphibians; therefore, potential direct and indirect effects to 

endangered fish and aquatic-phase amphibian species are considered equivalent.

3 Potential indirect effects on a taxon attributable to direct effects on birds, terrestrial-phase amphibians and 

reptiles.

4 Potential indirect effects on a taxon attributable to direct effects on mammals.

5 Both soybean uses to control soybean rust and leaf spot, cercospora blight and leaf spot, brown spot, and 

powdery mildew.

6 For control of leaf spot, cercospora blight and leaf spot, brown spot, and powdery mildew growing on soybeans 

only. 

The baseline risk assessment for endangered species indicates that the active ingredient, 

flutriafol, exceeds the LOCs for the specified use scenarios tabulated in Table I-7 for apples and 

Table I-8 for soybeans for the following taxonomic groups:

Table I-7. Flutriafol Endangered Species LOC Exceedances for Apple Use

Levels of Concern

Taxa Acute Endangered 

Species

Chronic 

Risk Listed Plants

Birds (including Reptiles and 

Terrestrial-phase Amphibians)

20 g Yes

100 g Yes Yes

1000 g No

Mammals 15 g Yes Yes

35 g Yes Yes

1000 g Yes Yes

Freshwater (including Aquaticphase Amphibians) and 

Estuarine/marine Fish

No No

Freshwater and Estuarine/marine 

Invertebrates No No

Terrestrial Monocots No

Terrestrial Dicots No

Aquatic Vascular Plants No

Aquatic Non-Vascular Plants No
14

Table I-8. Flutriafol Endangered Species LOC Exceedances for Soybean Use

Levels of Concern

Taxa Acute Endangered 

Species

Chronic 

Risk Listed Plants

Birds (including Reptiles and 

Terrestrial-phase Amphibians)

20 g Yes1

100 g No No

1000 g No

Mammals 15 g Yes2 No

35 g Yes2 No

1000 g No No

Freshwater (including Aquaticphase Amphibians) and 

Estuarine/marine Fish

No No

Freshwater and Estuarine/marine 

Invertebrates No No

Terrestrial Monocots No 

Terrestrial Dicots No

Aquatic Vascular Plants No

Aquatic Non-Vascular Plants No

1 Based on 3 applications @ 0.06 lb ai/A with a 14-day interval.

2 Based on 3 applications @ 0.06 lb ai/A with a 14 day interval and 3 applications @ 0.06 lb ai/A with a 21-

day interval.

The baseline risk assessment for endangered species indicates that the formulated product of 

flutriafol, Flutriafol 125 g/L SC, exceeds the LOCs for the specified use scenario tabulated below 

(Table I-9 for apples and soybeans) for the following taxonomic groups:

Table I-9. Flutriafol 125 g/L SC Endangered Species LOC Exceedances for Apple and Soybean 

Uses1

Levels of Concern

Taxa Acute Endangered Species Listed Plants

Birds (including Reptiles and 

Terrestrial-phase Amphibians)

20 g

100 g No data

1000 g

Mammals 15 g No

35 g No

1000 g No

Freshwater (including Aquaticphase Amphibians) and 

Estuarine/marine Fish

No

Freshwater Invertebrates No

Estuarine/marine Invertebrates No

Terrestrial Monocots No

Terrestrial Dicots No

Aquatic Vascular Plants No

Aquatic Non-Vascular Plants No

1 Based on the formulated product as a whole

F. Uncertainties and Data Gaps

 

1. Environmental Fate and Exposure Assessment
15

 Several non-guideline terrestrial field dissipation studies with applications over multiple 

years showed that flutriafol residues were found at all sampling depths throughout the 

duration of the studies. However, no field data quantifying the depth of leaching under 

actual use conditions have been provided. As a result, the combination of leaching and 

persistence would indicate a potential for ground water contamination. 

 No major degradates (10% or more of applied test material residues) of flutriafol were 

identified in any submitted studies. The persistence of the parent compound suggests that 

major degradates might have formed if the multiple year terrestrial field dissipation studies 

had tested for degradation products (MRIDs 47115502, 47090431). The minor triazol 

degradate of known toxicity (1,2,4-triazole), which has been identified in laboratory soil 

photolysis and anaerobic aquatic metabolism studies is a human health concern by the OPP 

Health Effects Division (HED)2, has not been considered in this ecological assessment by the 

OPP Environmental Fate and Effects Division (EFED), but will be assessed at a later date in 

an OPP cumulative assessment. 

 Several non-guideline terrestrial field dissipation studies with applications over multiple 

years indicate that flutriafol residues will remain undegraded, allowing residues to carry-over 

from year to year under actual use conditions. As a result, it is difficult to estimate the 

maximum amount of flutriafol residues which might accumulate from successive annual 

applications. 

 Since the varying physical-chemical properties of individual components of the formulated 

product (Flutriafol 125 g/L SC) will result in progressively different formulation constituents 

in the environmental media over time and there are no data about the environmental fate 

properties of the product, GENEEC2 and PRZM/EXAMs are unable to generate exposure 

concentrations of the product for comparison with the available toxicity data on the product. 

For this assessment, acute risks of the formulated product (Flutriafol 125 g/L SC) to aquatic 

animals was compared with the toxicity value of the formulated product as a whole to the 

AgDRIFT exposure concentrations.

 Since the AgDRIFT EECs are used as spray drift (or ‘acute’) exposure endpoints in the 

assessment, no chronic exposure endpoints (from spray drift or runoff) are available for the 

formulated product. Thus, it is not possible to evaluate the chronic exposure of the 

formulated product (active and inert ingredients) to animals and plants. 

 Flutriafol residues have been detected in surface samples taken from the Svalbard 

archipelago ice cap in arctic Norway. This seems to contradict both field volatility and 

Henry’s Law Constant data, which would predict a low likelihood of long-distance transport. 

In an article appearing in Environmental Science and Technology3, it has been suggested that 

atmospheric persistence combines with long term atmospheric transport due to fast moving 

 

2

http://www.epa.gov/opprd001/factsheets/tetraHHRA.pdf

3 Hermanson, Mark H, et. al, Current-Use and Legacy Pesticide History in the Austfonna Ice Cap, 

Svalbard, Norway, Environmental Science and Technology, 2005, vol. 39, pp. 8163 – 8169.
16

summer air masses. EFED has no means of quantifying this atmospheric transport at this

time.

2. Ecological Effects

Additional uncertainty results from the lack of ecological effects information and/or data as 

follows:

 Toxicity data for freshwater fish and invertebrates, mammals, and terrestrial and aquatic 

plants with the formulated product, Flutriafol 125 g/L SC, are available. A comparison of the 

available formulated product (TOPGUARD fungicide) and technical grade toxicity data 

shows the formulated product, when results are expressed in terms of the active ingredient, is

approximately 30 to 50-fold more toxic than technical grade flutriafol in an aquatic 

environment. Formulation blank data suggest the greater toxicity of the formulated product is 

not due to synergistic effects of the combination of the active ingredient and inerts, but is due 

to the toxicity of one or more of the inert ingredients. A change in the inert ingredients for 

TOPGUARD could mitigate the toxicity to aquatic organisms and plants. 

 There are no avian acute oral toxicity data available for passerine birds. The survival of 

passerine birds exposed to the active ingredient (AI) is uncertain. A risk assessment for acute 

exposure to passerine birds is needed based on flutriafol’s agricultural uses on soybeans and 

apples. In addition, the AI is classified as slightly toxic to upland game birds (partridge).

Since the 40 CFR 158 guidelines were updated, the Agency has worked to finalize its update 

to the data requirements in 40 CFR 158, which were promulgated in October 2007. An avian 

acute oral study with a passerine bird is required to support the terrestrial outdoor use 

patterns that are expected to reach this environment. Given the acute LOC exceedances for 

non-passerine birds in this baseline risk assessment, it is possible that passerine birds would 

be at risk from flutriafol exposures. The data will be utilized to determine whether the 

Agency’s current measures are effective for protecting passerine birds.

 There are no chronic toxicity data available for estuarine/marine fish and invertebrates; thus, 

the potential chronic risk of flutriafol is quantitatively estimated using ACR (acute to chronic 

ratio) values. Until chronic toxicity data are available, the potential risks to estuarine/marine 

animals are uncertain. Given that there are no chronic LOC exceedances using estimated 

toxicity values of the active ingredient (AI) combined with the indication of minimal acute 

and chronic risks for freshwater animals, chronic risk to estuarine/marine animals exposed to 

the AI is expected to be minimal. However, if data are submitted and are lower than the 

estimated NOAECs, the potential risk to the reproduction and growth of estuarine/marine 

fish and invertebrates may be underestimated.

 There are no toxicity data available for estuarine/marine fish and invertebrates with the 

formulated product, Flutriafol 125 g/L SC, to evaluate the toxicity of the active ingredient 

(AI) in its formulated product; thus, the potential acute risk of the product to these taxa is

quantitatively estimated using AAR (acute to acute ratio) values. Until these toxicity data are 

available, the potential risks to estuarine/marine fish and invertebrates are uncertain. 
17

Submission of estuarine/marine toxicity studies with Flutriafol 125 g/L SC would reduce the 

uncertainty associated with using an AAR.

 Technical grade active ingredient or formulation toxicity data on sediment dwelling 

organisms have not been submitted. Based on the persistence of flutriafol in water and the 

toxicity of flutriafol to other aquatic organisms, toxicity data on sediment dwelling organisms 

would greatly strengthen this assessment. 

3. Endangered Species

 With LOC exceedances for direct effects to birds, reptiles, terrestrial-phase amphibians, and 

mammals based on flutriafol use in agricultural areas where soybeans and apples are grown,

LOCATES was run for all listed birds, reptiles, terrestrial-phase amphibians, and mammals

in the database to determine the potential for co-occurrence of listed species locations with 

areas of potential fungicide use. Consequently, based on the information available at this 

step in the assessment process, it is presumed that all listed birds, reptiles, terrestrial-phase 

amphibians, and mammals are potentially affected directly and indirectly to all those taxa 

that are dependant on these taxa from the flutriafol uses in agricultural areas, should exposure 

actually occur. Additional analysis of listed species locations, refinement of the action area 

associated with flutriafol regulatory decisions, and the biology of the potentially affected 

species would be needed before an effects determination can be made for any of the colocated species identified by this assessment.
18

II. PROBLEM FORMULATION

The purpose of this risk assessment is to assess ecological risks associated with the new active 

ingredient, flutriafol ((RS)-2,4'-difluoro-a-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol), and 

its formulated product, Flutriafol 125 g/L SC, when used on apples and soybeans. As such, this 

document articulates the purpose and objectives of the risk assessment, evaluates the nature of 

the problem, and provides a plan for analyzing the data and characterizing the risk(s) (EPA, 

1998).

A. Nature of Regulatory Action

Under the authority of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 

Cheminova, Inc. is seeking the registration of the new active ingredient, flutriafol, for use as a 

systemic fungicide on apples and soybeans. 

B. Stressor Source and Distribution

1. Nature of the Chemical Stressor 

The new active ingredient, flutriafol ((RS)-2,4'-difluoro-a-(1H-1,2,4-triazol-1-

ylmethyl)benzhydryl alcohol), is a triazole derivative used as a systemic conazole fungicide

(Figure 1). Flutriafol belongs to a group of demethylation inhibitors (DMI fungicides). The 

mode of action for flutriafol is as a sterol biosynthesis inhibitor (SBI) that inhibits microsomal 

sterol demethylation in membranes. Common with all other DMI fungicides, flutriafol has a 

nitrogen atom that attaches to the center of an iron group within the cytochrome, which prevents 

or blocks the formation of ergosterol during demethylation. Flutriafol is a member of the triazole 

class of fungicides. Other members of this class are registered for use in the United States. 

Flutriafol is registered in other countries as well. 

A summary of selected physical, chemical, and environmental fate properties of flutriafol is 

presented in Table II-1. Abiotic degradation through hydrolysis and aqueous photolysis are very

slow for flutriafol. In soil, flutriafol is persistent, with a half-life value of more than one year. 

Flutriafol degraded more rapidly under anaerobic aquatic environments with a total half-life

value of about 6 weeks. Freundlich soil:water partitioning coefficients for flutriafol ranged from 

3.2 to 9.8 L/kg. Organic carbon partitioning coefficients ranged from 140 to 420 L/kg-OC. These 

data suggest flutriafol is moderately mobile in terrestrial and aquatic environments. 

Bioaccumulation is not expected due to the low octanol-water partitioning coefficient (log Kow

value of 2.3). Field dissipation studies show that flutriafol is persistent and mobile. Additionally, 

there was accumulation of flutriafol in soil in long field dissipation studies. 

The potential for mobility and high persistence of flutriafol suggest that leaching is the major 

route of dissipation. Although the vapor pressure and Henry’s Constant of flutriafol are low,

flutriafol residues have been detected in surface samples taken from the Svalbard archipelago ice 

cap in arctic Norway4indicating a potential for long term atmospheric transport. It has been 

 

4 Hermanson, Mark H, et. al, Current-Use and Legacy Pesticide History in the Austfonna Ice Cap, 

Svalbard, Norway, Environmental Science and Technology, 2005, vol. 39, pp. 8163 – 8169.
19

theorized that transport results from a combination of apparent atmospheric persistence and fast 

moving summer air masses. EFED has no means of quantifying this atmospheric transport at 

this time, and, as a result, this remains an uncertainty in this assessment. 

Due to the slow degradation of flutriafol, major degradates were not detected in either laboratory

or field studies. Minor degradates of flutriafol, which were only reported in two studies, a soil 

photolysis study and an anaerobic aquatic metabolism study include 1,2,4-triazole, triazole acetic 

acid, triazole alanine, 2,4’-difluorobenzophenone, and carbon dioxide (CO2). With the exception 

of 1,2,4-triazole, none of the degradates above were considered a human health concern by the 

OPP Health Effects Division (HED). 1,2,4-Triazole was a minor degradate in the submitted 

studies, but is a common degradate to other conazole fungicides. 1,2,4-Triazole has been 

determined to be a human health concern. As a result, its fate properties and toxicity will be 

addressed by the Agency in a separate assessment. 

The chemical structure of flutriafol is provided in Figure 1. 

Figure 1. Chemical Structures

(a) Flutriafol

N

N N C

H2

O H

F

F

N

N NH

(b) 1,2,4-Triazole

Table II-1 Physical, Chemical and Environmental Fate Properties of Flutriafol

Physical and Chemical Properties

Chemical Name (common) Flutriafol

Chemical Name (CAS) α-(2-Fluorophenyl)-α-(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol

Chemical Abstract Number (CAS 

Number) 76674-21-0

Chemical Class conazole

Molecular Weight (g/mol) 301.3

Aqueous Solubility (20 C) 130 mg/L

pKa 2.3 A

Vapor Pressure 4 x 10-7

Pa 

Henry’s Law Constant (20  C) 1.3 x 10-11 atm x m3 x mol-1

Octanol/water Partition Coefficient (log 

Kow at pH7) 2.29 B
20

Table II-1 Physical, Chemical and Environmental Fate Properties of Flutriafol

Physical and Chemical Properties

Environmental Fate Properties

Hydrolysis Half-life (pH 5, 7) t1/2 = stable

Aqueous Photolysis Half-life t1/2 = stable

Soil Photolysis Half-life t1/2 = 72.2 days (extrapolated)

Aerobic Soil Metabolism Half-lives (total 

system) t1/2 = 120, 161, 257, 84, 98, 315, 3466, 347, and 239 weeks

Anaerobic Metabolism Half-lives (total 

system)

t1/2 = < 1 day in water

t1/2 = > 365 days in total system

Aerobic Aquatic Metabolism Half-lives t1/2 = 42.6 days in water

t1/2 = > 100 days in total system

Soil-Water Partitioning Coefficients 

(Koc)

498, 205, 379, 230, 340, 428, 140 

Bioaccumulation in Fish Maximum BCF values are 6.8 for whole fish (day 3), 4.7 for muscle tissue 

(day 3), and 12.2 for viscera tissue (day 21)

Terrestrial Field Dissipation

(total system; non-linear) t1/2 = 1155, 3466, 2310, 990, 408, 1733, 105, 99, 696, and 261days 

A

http://sitem.herts.ac.uk/aeru/footprint/en/Reports/353.htm

B

http://www.google.com/search?hl=en&q=Flutriafol+kOW

In addition to the new active ingredient, the Agency has identified concerns with the new 

formulated product (Flutriafol 125 g/L SC). For risk assessment purposes, this assessment 

considers exposure to the active ingredient, as well as its formulated product, Flutriafol 125 g/L

SC.

2. Overview of Pesticide Usage 

Cheminova, Inc. is seeking the registration of flutriafol as a new fungicide for use to control 

fungal diseases on soybeans and apples. Flutriafol is formulated as a soluble concentrate

(Flutriafol 125 g/L SC) for broadcast foliar application to crops through ground and aircraft 

spray equipment. Flutriafol 125 g/L SC is labeled as TOPGUARDTM for agricultural use. 

Further characterization of the use is provided in Section III-A.

C. Receptors

Registrant-submitted toxicological studies with surrogate test species will be utilized for this 

baseline risk assessment for flutriafol (Table II-2). Toxicological data generated from surrogate 

test species, which are intended to be representative of broad taxonomic groups, are used to 

extrapolate potential effects on a variety of species (receptors) included under these taxonomic 

groupings. A complete discussion of all toxicity data available for this risk assessment for 

TGAI, formulated products, and the resulting measurements of effect selected for each 

taxonomic group are included in Section III.C and Appendix F.
21

The receptor is the biological entity that is exposed to the stressor (EPA, 1998). Acute and 

chronic toxicity data from studies submitted by pesticide registrants along with the available 

open literature are used to evaluate the potential direct effects of flutriafol to the aquatic and 

terrestrial receptors identified in this section. This includes toxicity data on the technical grade 

active ingredient and its formulated products. The open literature studies are identified through 

EPA’s ECOTOX database http://cfpub.epa.gov/ecotox/), which employs a literature search 

engine for locating chemical toxicity data for aquatic life, terrestrial and aquatic plants, and 

wildlife. The evaluation of both sources of data can also provide insight into the direct and 

indirect effects of flutriafol on biotic communities from loss of species that are sensitive to the 

chemical and from changes in structure and functional characteristics of the affected 

communities. 

1. Aquatic Effects 

The toxicity of flutriafol technical to aquatic animals and plants is assessed using acute and 

chronic laboratory studies submitted by the registrant to the Agency. Acute toxicity data for 

flutriafol technical are available for surrogate freshwater fish, the rainbow trout (Oncorhynchus 

mykiss) and bluegill sunfish (Lepomis macrochirus), as well as for a surrogate freshwater 

invertebrate, the water flea (Daphnia magna). Acute toxicity data for flutriafol technical are 

available for surrogate estuarine/marine fish, sheepshead minnow (Cyprinodon variegatus), as 

well as for surrogate estuarine/marine invertebrates, Eastern oyster (Crassostrea virginia) and

mysid shrimp (Americamysis bahia). Data are available to evaluate chronic effects to freshwater 

fish (rainbow trout) and invertebrates (water flea). The potential chronic effects to 

estuarine/marine fish and invertebrates are uncertain because chronic toxicity data for flutriafol 

technical are not available. Toxicity studies are available to evaluate the effects of flutriafol to 

aquatic plants. Effects data for freshwater fish and invertebrates are available for the flutriafol 

formulated product, Flutriafol 125 g/L SC. 

Effects to aquatic animals and plants from flutriafol degradates are not available; therefore, the 

toxicological concerns to those species are uncertain. Since measured residue of the degradates

are less than 10% of parent equivalents and a structure analysis of the degradates suggests that

the degradates are less toxic than the parent compound to aquatic animals, it is likely that the 

degradates are not a toxicological concern. An exception to this is the minor degradate 1,2,4-

triazole. This degradate is a common degradate to other conazole fungicides and its fate 

properties and toxicity will be addressed by the Agency in a separate assessment. 

2. Terrestrial Effects 

The effect of flutriafol technical on all bird species is estimated from acute, subacute and chronic 

studies on two preferred species, bobwhite quail (Colinus virginianus) and mallard duck (Anas 

platyrhynchos) and an acceptable upland game bird species, the red-legged partridge (Alectoris 

rufa). However, data are not available for passerine birds. These bird species also act as 

surrogates for reptiles and terrestrial-phase amphibians when data on those species are not 

available. Effects of flutriafol technical and its formulated product on mammals are estimated 

from acute and chronic rat studies reviewed by the Registration Division (RD) and Health 

Effects Division (HED).
22

Acute contact honeybee toxicity tests with flutriafol technical and flutriafol formulated products 

(IMPACT®, SC JF 8496) are available to assess the potential risk to non-target terrestrial 

invertebrates. 

Terrestrial plant studies (seedling emergence and vegetative vigor) are available to evaluate the 

effects of flutriafol to terrestrial monocots and dicots. 

Effects to terrestrial animals and plants from flutriafol degradates were not available; therefore,

the toxicological concerns to those species are uncertain. Structure analysis suggests that the 

degradates are less toxic than the parent compound to aquatic animals. It may be similarly the 

case that the degradates are not a toxicological concern to terrestrial animals and plants. 

Table II-2 provides a summary of the taxonomic groups and the surrogate species tested to 

provide potential acute ecological effects data to non-target animals and plants. In addition, the 

table provides a preliminary overview of the potential acute toxicity of flutriafol by providing the 

acute toxicity classifications.

Table II-2. Test Species Evaluated for Assessing Potential Ecological Effects of Flutriafol TGAI and the 

Associated Acute Toxicity Classification 

Taxonomic Group Example(s) of Surrogate Species Acute Toxicity 

Classification

Birds1

[Oral] Mallard duck (Anas platyrhynchos) 

[Oral] Bobwhite quail (Colinus virginianus)

[Oral] Red-legged partridge (Alectoris rufa)

Slightly to practically 

non-toxic

[Dietary] Mallard duck (Anas platyrhynchos) 

[Dietary] Bobwhite quail (Colinus virginianus)

Slightly to practically 

non-toxic

Mammals Laboratory rat (Rattus norvegicus)

Laboratory mouse (Mus musculus)

Moderately to slightly 

toxic

Beneficial insects Honey bee (Apis mellifera L.) Practically non-toxic

Freshwater fish2 Bluegill sunfish (Lepomis macrochirus)

Rainbow trout (Oncorhynchus mykiss)

Slightly toxic 

Freshwater 

invertebrates Water flea (Daphnia magna) Slightly toxic

Estuarine/marine fish Sheepshead minnow (Cyprinodon variegatus)

No more than slightly 

toxic

Estuarine/marine 

invertebrates

Eastern Oyster (Crassostrea virginica)

Mysid (Americamysis bahia)

Slightly toxic

Terrestrial plants3

[Seedling Emergence and Vegetative Vigor] Monocot –

Corn, Onion, Ryegrass, Wheat

[Seedling Emergence and Vegetative Vigor] Dicot –

Cabbage, Lettuce, Radish, Soybean, Sugar beet, Tomato

Not classified

Aquatic plants and 

algae

Vascular – Duckweed (Lemna gibba)

Non-Vascular - Green algae (Pseudokirchneriella 

subcapitata), Blue-green algae (Anabaena flos-aquae), 

Freshwater diatom (Navicula pelliculosa), Marine diatom 

(Skeletonema costatum)

Not classified

1Birds represent surrogates for amphibians (terrestrial phase) and reptiles.

2

Freshwater fish may be surrogates for amphibians (aquatic phase).

3

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

soybeans.
23

3. Ecosystems at Risk 

The terrestrial ecosystems typically at risk include the treated area and areas immediately

adjacent to the treated area that might receive spray drift, runoff, or wind-erosion of soil 

particles. Aquatic ecosystems typically at risk include water bodies receiving runoff and/or drift 

from treated sites. 

For both terrestrial and aquatic animal species, direct and indirect acute and chronic exposures 

are considered. Risk will be assessed to terrestrial plants assumed to exclusively occur in areas 

immediately adjacent to, and in transition areas receiving runoff and spray drift from treated 

areas. The labeled uses of flutriafol could result in exposure to aquatic and terrestrial animals and 

plants inhabiting flowing, non-flowing or transient freshwater/marine water bodies, wetlands and 

transitional areas, and to wild lands (forests and ecotones, such as edge and riparian habitats) 

adjacent to the agricultural use of flutriafol. For uses in coastal areas where apples are grown, 

aquatic habitat also includes marine and estuarine ecosystems. 

D. Assessment Endpoints

Assessment endpoints are defined as “explicit expressions of the actual environmental value that 

is to be protected.” Defining an assessment endpoint involves two steps: 1) identifying the 

valued attributes of the environment that are considered to be at risk; and 2) operationally 

defining the assessment endpoint in terms of an ecological entity (i.e., a community of fish and 

aquatic invertebrates) and its attributes (i.e., survival and reproduction). Therefore, selection of 

the assessment endpoints is based on value entities (i.e., ecological receptors), the ecosystems 

potentially at risk, the migration pathways of pesticides, and the routes by which ecological 

receptors are exposed to pesticide-related contamination. The selection of clearly defined 

assessment endpoints is important because they provide direction and boundaries in the risk 

assessment for addressing risk management issues of concern.

A summary of the assessment and measurement endpoints selected to characterize potential 

ecological risks associated with exposure to flutriafol are summarized in Table II-3. The 

ecological relevance of selecting these assessment endpoints is as follows: 1) complete exposure 

pathways exist for these receptors, 2) the receptors may be potentially sensitive to pesticides in 

affected media and in residues on plants, seeds, and insects, and 3) the receptors could 

potentially inhabit areas where pesticides are applied or areas where runoff and/or drift may

impact the sites.

This ecological risk assessment estimates exposure concentrations based on labeled maximum 

application rates, maximum number of applications, and minimum intervals between 

applications. Exposure scenarios are proposed to evaluate potential risks to non-target wildlife 

and plants from flutriafol treatments in apple and soybean sites. Five exposure scenarios were

estimated for the proposed uses of flutriafol: 4 ground applications at maximum application rate 

of 0.11 lbs ai/A with a 7 day reapplication interval; 3 ground applications at 0.06 lb ai/A with a 

21 day reapplication interval; 3 aerial applications at 0.06 lb ai/A with a 21 day reapplication 

interval; 3 ground applications at 0.06 lb ai/A with a 14 day interval; and 3 aerial applications at 

0.06 lb ai/A with a 14 day interval.
24

This assessment is intended to represent high-end exposures at a national level. Likewise, the 

most sensitive toxicity endpoints are used from surrogate test species to estimate treatmentrelated direct effects on acute mortality and chronic reproductive, growth and survival 

assessment endpoints. Toxicity tests are intended to determine effects of pesticide exposure on 

birds, mammals, fish, terrestrial and aquatic invertebrates, and terrestrial and aquatic plants. 

These tests include short-term acute, subacute, and reproduction studies and are typically 

arranged in a hierarchical or tiered system that progresses from basic laboratory tests. The 

toxicity studies are used to evaluate the potential of a pesticide to cause adverse effects, to 

determine whether further testing is required, and to determine the need for precautionary label 

statements to minimize the potential adverse effects to non-target animals and plants (CFR 40 

§158.202, 2002). 

In order to protect threatened and endangered species, all assessment endpoints are measured at 

the individual level. Measuring endpoints at the individual level also provides insight about risks 

at higher levels of biological organization (e.g. populations and communities). For example, 

pesticide effects on individual survivorship have important implications for both population 

growth increase and habitat carrying capacity.

E. Conceptual Model

1. Risk Hypotheses

Risk hypotheses are specific assumptions about potential adverse effects (i.e. changes in 

assessment endpoints) and may be based on theory and logic, empirical data, mathematical 

models, or probability models (EPA, 1998). For this assessment, the risk is stressor-linked, 

where the stressor is the release of flutriafol to the environment. The following risk hypothesis is 

presumed for this baseline assessment.

The use of flutriafol and its formulated product as a fungicide for terrestrial outdoor uses will 

result in exposure to terrestrial and aquatic animals and plants. Based on the persistence and 

mobility of flutriafol, the mode of action, the application methods, and food-web of the target 

terrestrial ecosystems, flutriafol and its formulated product have the potential to cause reduced 

survival, and reproductive and growth impairment for both terrestrial and aquatic animal and 

plant species. 

2. Conceptual Model

The conceptual model is used to depict the potential routes of exposure from flutriafol and its 

formulated product when used as a fungicide on apples and soybeans in terrestrial outdoor 

settings. All potential routes of exposure are considered and presented in the conceptual model 

(Figure 2). The conceptual model generically depicts the potential source of flutriafol, release 

and transport mechanisms, receiving media, biological receptor types, and effects endpoints of 

potential concern.

In order for a chemical to pose an ecological risk, it must reach ecological receptors in 
25

biologically significant concentrations. An exposure pathway is the means by which a 

contaminant moves in the environment from a source to an ecological receptor. For an 

ecological exposure pathway to be complete, it must have a source, an environmental transport 

medium, a point of exposure for ecological receptors, and a feasible route of exposure. The 

assessment of ecological exposure pathways, therefore, includes an examination of the source 

and potential migration pathways for constituents, and the determination of potential exposure 

routes (e.g., ingestion, inhalation, dermal contact).

Potential exposure pathways by which flutriafol may inadvertently affect non-target plant and 

animal populations in aquatic areas are drift during spray application and runoff/leaching of 

contaminated water from treated areas to untreated areas. In semi-aquatic areas, the exposure 

routes are drift during spray application, runoff events (off-site movement of contaminated 

water), leaching, atmospheric transport, and wind erosion of contaminated soil particles. There 

may be exposure to non-target terrestrial plants adjacent to treated areas via drift, runoff and 

atmospheric transport from transitional sites or wetlands that may be dry during certain periods, 

or via wind-blown treated soil particles from those pathways for aquatic species. In addition, 

sediment-dwelling organisms may be exposed to flutriafol because the pesticide is expected to be 

persistent in water. Exposure through aquatic media will mainly be to the parent compound 

since flutriafol is persistent in the environment. 
26

Application of Flutriafol and its Formulation Product to Apples and Soybeans through Ground and 

Aerial Spray Equipment in Agricultural Settings Stressor

Direct Ground Deposition

Volatilization/

Wind Suspension Leaching

Non-Target Plants:

•Seedling emergence

•Vegetative vigor

•Reductions in cell density/ 

biomass in aquatic plants

Source:

Transport Pathway

Terrestrial Animals:

•Lethality

•Reproductive/developmental

effects

Aquatic Animals and Plants:

•Effects to survival, growth, and 

reproduction

Source:

Exposure Media

Exposure Point

Receptors

Attribute 

Changes

Terrestrial Food Residues

(foliage, fruit, insects)

Direct Contact

& Ingestion

Terrestrial

Vertebrates and 

Invertebrates

Direct Contact/

Root Uptake

Terrestrial

Upland

Plants

Surface Water

Sediment Groundwater

Gill/Integument

Uptake

Aquatic

Invertebrates &

Vertebrates

Upland Soil and 

Foliage

Riparian/Wetland

Foliage/Soil

Spray

Drift Runoff/

Erosion

Uptake/

Adsorption

Riparian/

Wetland

Plants

Aquatic

Plants

Plant Population

Reduced Population

growth

Figure 2. Flutriafol Environmental Risk Conceptual Model

Solid line indicate possible pathway

Bolded line indicate likely pathway
27

F. Analysis Plan

In order to address the risk hypothesis, the potential for adverse effects on non-target aquatic and 

terrestrial animals and plants is estimated. In the following sections, the use, environmental fate, 

and ecological effects of flutriafol and its formulated product are characterized and integrated to 

assess the risks. This is accomplished using a risk quotient (ratio of exposure concentration to 

effects concentration) approach. Although risk is often defined as the likelihood and magnitude 

of adverse ecological effects, the risk quotient-based approach does not provide a quantitative 

estimate of likelihood and/or magnitude of an adverse effect. Such estimates may be possible 

through a more refined, probabilistic assessment; however, they are beyond the scope of this 

baseline assessment. This analysis provides the basis for estimating and describing risks, 

identifying uncertainties in the risk hypothesis, and recommendations for new data collection if 

needed to fill the data gaps.

This assessment only considers the potential effects of flutriafol fungicide exposure as a result of 

the currently proposed uses. The Agency does not routinely include an evaluation of mixtures of 

active ingredients, either those mixtures of multiple active ingredients in product formulations or 

those in the applicator’s tank. In the case of the product formulations of active ingredients (that 

is, a registered product containing more than one active ingredient), each active ingredient is 

subject to an individual risk assessment for regulatory decision regarding the active ingredient on 

a particular use site. If effects data are available for a formulated product containing the active 

ingredient, they may be used qualitatively or quantitatively in accordance with the Agency’s 

Overview Document and the Services’ Evaluation Memorandum (U.S., EPA 2004; 

USFWS/NMFS 2004). 

For this baseline ecological risk assessment, estimated environmental concentrations (EECs) for 

aquatic and terrestrial systems were calculated using exposure scenarios for soybean and apple 

use according to label information. EECs were calculated using T-REX (version 1.3.1), 

GENEEC2 (version 2.0), PRZM(Version 3.12.2)/EXAMs (Version 2.98.04), and the AgDRIFT 

(Version 2.0.1). Baseline terrestrial and aquatic concentrations represent values for a generic 

crop grown in a generic location which have been chosen to represent all crop uses. EECs, and 

the resulting risk quotients from the TerrPlant model for terrestrial plants growing in dry and 

semi-aquatic environments, are generated by using the seedling emergence and vegetative vigor 

toxicity information at the maximum proposed application rate. 

1. Preliminary Identification of Data Gaps and Methods

The environmental fate database for parent compound flutriafol is essentially complete. The 

available data are generally sufficient for risk assessment purposes of the parent compound, 

flutriafol. Several studies (e.g. terrestrial field dissipation) are classified as supplemental due to 

a failure to identify all possible toxic degradation products. The triazol degradate, which was 

identified in studies where both major and minor degradates were characterized, is a common 

degradate to proposed and registered conazole pesticides. A cumulative assessment for residues 

of the triazol degradate has been separately assessed by OPP for human health effects. They

will be assessed separately for ecological effects by EFED at a later date, and are not included in 
28

this assessment. 

The ecological toxicity database for flutriafol is largely complete for terrestrial and aquatic 

animals and plant species. 

The following uncertainties and information gaps are identified as part of the problem 

formulation:

An avian acute oral ecological toxicity study with passerine birds is required to satisfy EPA 

guidelines. 

Toxicity data on sediment dwelling animals are not available. Even though flutriafol is expected

to persist in the environment and repeated applications may lead to accumulation of flutriafol 

residues in the sediment, the toxicity of the AI to those animals is uncertain. Based on the high 

toxicity of flutriafol to other aquatic animals, toxicity data on sediment dwelling animals would 

greatly strengthen this assessment. 

There are additional uncertainties associated with using the acute-to-acute ratio (AAR) and 

acute-to-chronic ratio (ACR) to estimate acute and/or chronic toxicity values for aquatic animals. 

The ratios derived for these aquatic animals assume that the ratios from different species are 

conserved across species (i.e., sunfish to minnow). If data on the specific species are submitted 

and are higher or lower than the derived toxicity value for these aquatic animals, then risk could 

be under- or over-estimated, respectively.

2. Measures of Exposure and Effects 

a. Measures of Exposure

Aquatic Animals and Plants 

Tier I simulation model GENEEC2 (Version 2.0; August 1, 2001) and Tier 2 PRZM (Version 

3.21.2)/EXAMS (2.98.04) are used to generate estimated environmental concentrations (EECs) 

of the active ingredient. The predicted peak, 21-day, and 60-day concentrations are used to 

estimate acute and chronic risks to aquatic animals inhabiting shallow-water aquatic 

communities that receive runoff during rainfall events and/or drift of the active ingredient from 

adjacent use sites. 

GENEEC2 assumes application of the active ingredient to a 10-hectare agricultural field, planted 

solely in a generic crop, that drains into an adjacent 1-hectare water body, 2 meters deep (20,000 

m

3

volume) with no outlet. This generic agricultural scenario is representative of flutriafol use 

on apples and soybeans, and is likely to result in conservative estimates of exposure. GENEEC2 

considers adsorption of the active ingredient to soil or sediment, direct deposition of spray drift 

into the water body, and degradation of the pesticide in soil before runoff and within the water 

body. It is a single event model, meaning that it assumes one single large rainfall/runoff event 

from a standard size field to a standard size ecological pond.
29

PRZM/EXAMS modeling assumes application of the active ingredient to a 10-hectare 

agricultural field that drains into an adjacent 1-hectare water body, 2 meters deep (20,000 m3

volume) with no outlet. Unlike GENEEC2, PRZM/EXAMS modeling considers site specific 

properties (ie, soil type and meterology) and agronomic practices (ie, pesticide application 

timing, pesticide application method) for specific crops. Thirty year model simulations are 

conducted to provide an estimate of 1 in 10 year peak, 21-day average and 60 day average EECs. 

Model input parameters are selected based on laboratory fate data in accordance with EFED’s 

input parameter guidance5. Tier I modeling is conducted based on the maximum potential 

number of applications, maximum application rates, and the shortest application interval. Five 

exposure scenarios were estimated for the proposed uses of flutriafol: 4 ground applications at 

maximum application rate of 0.11 lbs ai/A with a 7 day reapplication interval; 3 ground 

applications at 0.06 lb ai/A with a 21 day reapplication interval; 3 aerial applications at 0.06 lb 

ai/A with a 21 day reapplication interval; 3 ground applications at 0.06 lb ai/A with a 14 day

interval; and 3 aerial applications at 0.06 lb ai/A with a 14 day interval. Tier II PRZM/EXAMS 

modeling was conducted for apples using 4 ground spray applications at a maximum application 

rate of 0.11 lbs ai/A with a 7 day reapplication interval. 

In circumstances where toxicity data with the formulated product were available, AgDRIFT 

(Version 2.1) was used to generate estimated environmental concentrations (EECs) for the 

formulated product that may drift immediately to water bodies adjacent to the application sites. 

The predicted spray drift EECs were used to estimate risk to aquatic animals and plants 

inhabiting shallow-water aquatic communities that receive incidental spray drift of the 

formulated product from adjacent use sites. 

Terrestrial Animals and Plants

The potential exposure pathways for terrestrial plants and animals include deposition from spray

applications, runoff/leaching from treated areas, spray drift, and wind erosion of soil particles 

resulting in residues on non-target species as well as residues on food items for non-target 

species. As part of the terrestrial assessment, EFED used the models T-REX (ver. 1.3.1.) and 

TerrPlant (ver. 1.2.2) to estimate exposure concentrations of flutriafol to non-target terrestrial 

animals and plants, respectively. 

T-REX assumes application of the active ingredient to a one-acre agricultural field that settles on 

food items of avian and mammalian species (short and tall grass, broadleaf forage, large and 

small insects, fruits, pods, and seeds) within the field. TerrPlant assumes application of the active 

ingredient to a one-acre agricultural field that drifts and/or is subject to runoff off site to adjacent 

fields of non-target plants. 

 

AgDRIFT (Version 2.1) was used to estimate environmental concentrations (EECs) of the enduse product that may drift to areas adjacent to the application sites. The predicted spray drift 

EECs are used to estimate risk to terrestrial animals inhabiting the edge of the field that receive 

incidental spray drift of the formulated product from adjacent use sites. 

 

5

http://www.epa.gov/oppefed1/models/water/input_guidance2_28_02.htm
30

b. Measures of Effects

Measures of ecological effects are obtained from submitted guideline studies conducted with a 

limited number of surrogate species on flutriafol. The test species are not intended to be 

representative of the most sensitive species but rather were selected based on their ability to 

thrive under laboratory conditions and their standardized use for toxicity studies of a variety of 

chemicals. Submitted ecological effects data comply with good laboratory testing requirements. 

These data are summarized in the Ecological Effects Section and in Appendix F. 

As stated above, toxicity testing does not represent all species of birds, mammals, or aquatic 

animals. Only a few surrogate species for both freshwater fish and birds are used to represent all 

freshwater fish (2000+) and bird (680+) species in the United States. For mammals, acute 

studies are usually limited to the laboratory rat. Estuarine/marine testing is usually limited to a 

crustacean, a mollusk, and a fish. In addition, neither reptiles nor amphibian data are available. 

The risk assessment assumes that avian, terrestrial-phase amphibian and reptilian toxicities are 

similar. The same assumption is used for fish and aquatic-phase amphibians. 

A summary of the assessment and measurement endpoints selected to characterize potential 

ecological risks associated with exposure to technical grade, the active ingredient in the 

formulated product, and its formulated product are summarized in Table II-3. 

Table II-3. Summary of Assessment Endpoints and Measures of Ecological Effects*

Assessment Endpoint Surrogate Species and Measures of Ecological 

Effect1 Measures of Exposure

Birds2

Survival Partridge acute oral LD50

Bobwhite and mallard subacute dietary LC50

Upper bound residues on 

food items (foliar)

Reproduction 

and growth

Bobwhite and mallard chronic reproduction 

NOAEC and LOAEC 

Mammals

Reproduction 

and growth

Laboratory rat oral reproduction chronic 

NOAEC and LOAEC

Survival Laboratory mouse acute oral LD50

Laboratory rat acute oral LD50 Spray drift EEC6

Freshwater fish3

Survival Rainbow trout and bluegill sunfish acute LC50

Peak EEC4

Spray drift EEC7

Reproduction 

and growth

Freshwater fish chronic (early life-stage) 

NOAEC and LOAEC

60-day average EEC4

Freshwater

invertebrates

Survival Water flea acute EC50

Peak EEC4

Spray drift EEC7

Reproduction 

and growth Water flea chronic (life cycle) NOAEC and LOAEC 21-day average EEC4

Estuarine/marine fish

Survival Sheepshead minnow acute LC50

Peak EEC4

Spray drift EEC7

Reproduction 

and growth

Sheepshead minnow chronic (early life-stage) 

NOAEC and LOAEC *(no study available)

60-day average EEC4

Estuarine/marine Survival Eastern oyster acute EC50 and mysid acute LC50 Peak EEC4
31

Table II-3. Summary of Assessment Endpoints and Measures of Ecological Effects*

Assessment Endpoint Surrogate Species and Measures of Ecological 

Effect1 Measures of Exposure

invertebrates Spray drift EEC7

Reproduction 

and growth

Mysid chronic NOAEC and LOAEC

*(no study available)

21-day average EEC4

Terrestrial plants5 Survival and 

growth

Monocot and dicot seedling emergence and vegetative 

vigor EC25 and NOAEC (or EC05) values 

Estimates of runoff and 

spray drift to non-target 

areas

Insects

Survival (not 

quantitatively 

assessed)

Honeybee acute contact LD50 

Maximum application 

rate

Aquatic plants and 

algae

Survival and

growth

Algal (marine diatom) and vascular plant (duckweed) 

EC50 and NOAEC values for growth rate and biomass 

measurements 

Peak EEC4

Spray drift EEC7

1 If species listed in this table represent most commonly encountered species from submitted studies, risk assessment guidance indicates 

most sensitive species tested within taxonomic group are to be used for baseline risk assessments.

2 Birds represent surrogates for amphibians (terrestrial phase) and reptiles.

3 Freshwater fish may be surrogates for amphibians (aquatic phase).

4 Based on GENEEC2 active ingredient modeling.

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

6 Based on AgDRIFT modeling; only used when mammal acute oral toxicity data with the formulated product is available.

7 Based on AgDRIFT modeling; only used when aquatic animal and plant acute toxicity data with the formulated product is available.

* LD50 = Lethal dose to 50% of the test population; NOAEC = No observed adverse effect concentration; LOAEC = Lowest observed 

adverse effect concentration; LC50 = Lethal concentration to 50% of the test population; EC50/EC25 = Effect concentration to 50%/25% of 

the test population.

III. ANALYSIS

A. Use Characterization

Cheminova Inc. is seeking the registration for the new active ingredient, flutriafol, for use to 

control fungal diseases on apples and soybeans. Flutriafol can be formulated as a soluble 

concentrate. Methods of application include foliar broadcast spray via ground or air. 

To control fungal diseases on apples, a maximum application rate of 0.11 lbs ai/A with no more 

than four applications per season is proposed. The shortest reapplication interval for apples is 7 

days. For flutriafol treatments in soybean fields to control soybean rust as per label information, 

a maximum application rate of 0.06 lbs ai/A applied no more than 3 times with 21-day

reapplication intervals is recommended. For control of frogeye leaf spot, cercospora blight and 

leaf spot, brown spot, and powdery mildew in soybean fields, the label recommends 3 

applications at 0.06 lbs ai/A with a reapplication interval of 14 days. 

This risk assessment focuses exclusively on the use patterns of flutriafol for control of 

susceptible fungal diseases on apples and soybeans. Use patterns tabulated in Table III-1 below 

serve as the basis for selecting the appropriate application rates and method used as part of the 

input parameters needed to obtain EECs with simulation models. 
32

Table III-1. Flutriafol Application Information

Method of

Application Crop

Maximum 

Application Rate

lb a.i./A

Maximum Number 

of Applications

(Interval)

PHI 

(Days)

Maximum 

Seasonal Use Rate 

lb a.i./A

Broadcast Foliar 

Spray (ground) Apple 0.11 4 applications(7 to 14-day interval) 14 0.44

Broadcast Foliar 

Spray (ground 

& aerial)

Soybean 0.06

3 applications

(21 to 35-day 

interval)

21 0.23

Broadcast Foliar 

Spray (ground 

& aerial)

Soybean 0.06

3 applications

(14 to 21-day 

interval)

21 0.23

B. Exposure Characterization

1. Environmental Fate and Transport Characterization 

a. Summary

Flutriafol is a conazole fungicide that is expected to be persistent and moderately mobile in the 

environment with the major routes of degradation through biotic processes. Laboratory

anaerobic aquatic data suggests more rapid degradation in aquatic environmental compartments 

(t 1⁄2 = 6 weeks). Flutriafol has a half-life of greater than one year in soil, and therefore repeated 

applications may lead to accumulation in soil. Flutriafol is expected to reach surface water 

through drift, atmospheric transport (as indicated by detection in Arctic ice samples), runoff, 

leaching, and/or erosion. Based on PRZM modeling, the dominant route of dissipation for 

flutriafol is leaching below the root zone. These modeling data are consistent with observations 

of flutriafol leaching in field dissipation studies as well as laboratory mobility data. 

Table III-2. Environmental Fate Properties of Flutriafol 

PARAMETER VALUE SOURCE COMMENT

Molecular Weight 301.3 amu Calculated

Henry’s Law Constant 1.3 x 10-11 atm x m3 x mol-1 

Vapor Pressure 4 x 10-7Pa (25○C)

Aqueous Solubility 130 mg/L

Hydrolysis half-life < 1 year MRID 47090416 (pH 4 7, 9)

Aqueous Photolysis half-life < 1 year

MRID 47287601

MRID 47090417

Photodegradation on Soil half-life = 72.2 days MRID 47418401 Continuous irradiation 

Aerobic Soil Metabolism 

half-lives = 6,932, 840, 

1127, 1799, 588, 686, 2205 

days

MRID 47090421

MRID 47090422
33

Table III-2. Environmental Fate Properties of Flutriafol 

PARAMETER VALUE SOURCE COMMENT

Aerobic Aquatic Metabolism 

(total system)

half-lives = 42.6 and 36.3 

days MRID 47090419

Anaerobic Soil Metabolism 

(total system)

half-lives = 6,932, 840, 

1127, 1799, 588, 686, 2205 

days

MRID 470090424

Soil Partition Coefficient (Kd) 3.7, 13.6, 10.6, 6.5, 2.0

MRID 47090425

MRID 47090426

MRID 47090427

Koc = 264, 340, 428, 140, 

498, 205, 379

Bioconcentration in Fish

4.7 X

12.2 X

6.8 X

MRID 47090437

edible tissue

visceral tissue

whole fish

Terrestrial Field Dissipation 

(total system)

half-life = 1155 days;

half-life = 3466 days,

half-life = 2310 days,

half-life = 1155 days,

half-life = 866 days,

half-life = 770 days, 

half-life = 866 days, 

half-life = 1155 days,

half-life = 1386 days.

MRID 47115502

MRID 47090431

-West Horsley, United 

Kingdom Loamy sand.

-Boxford, United Kingdom

-Clay loam.

-Chalgrove, United 

Kingdom Sandy clay loam. 

-Lichtenhagen, Germany 

soil type not reported. 

-Lichtenhagen, Germany 

soil type not reported 

-Mottingen, Germany 

soil type not reported. 

-Damsdorf, Germany 

soil type not reported 

-Bohringen, Germany/ 

soil type not reported 

-Wankendorf, Germany 

soil type not reported 

b. Persistence and Transformation 

Flutriafol is stable to both hydrolysis and aquatic photolysis, and moderately resistant to 

photodegradation on soil. Flutriafol biodegrades with half-lives of more than a year under 

aerobic and anaerobic conditions, in both terrestrial and total-system aquatic environments. 

Laboratory anaerobic aquatic data suggests more rapid degradation in aquatic environmental 

compartments (t 1⁄2 = 6 weeks). On the whole, flutriafol is expected to degrade with a half-life of 

more than one year in the environment. Repeated applications may lead to accumulation of 

flutriafol residues in soil. As a result, it is expected to persist for years, and to build up with 

successive annual applications in both aerobic and anaerobic environments. The degradates of 

flutriafol were only reported in two studies, a soil photolysis study and an anaerobic aquatic 

metabolism study include 1,2,4-triazole, triazole acetic acid, triazole alanine, 2,4’-

difluorobenzophenone, and carbon dioxide.
34

c. Transport and Mobility 

Batch equilibrium data on flutriafol suggest that the compound will sorb to soil with moderate 

affinity and display moderate mobility (Kd values range from 2.0 to 13). Because flutriafol 

biodegrades with half-lives of more than a year under aerobic and anaerobic conditions, in both 

terrestrial and total-system aquatic environments, there is a potential for build-up in soil with 

repeated applications. 

Because leaching, runoff, erosion, and accumulation in soil are probable processes controlling 

the environmental fate of flutriafol, PRZM modeling was conducted to assess the contribution of 

each process in controlling the environmental fate of flutriafol under field conditions. The PRZM 

modeling was conducted using the standard MS soybean scenario (Appendix M). 

Extensive accumulation of flutriafol residues in soil was not observed in the MS soybean 

scenario (Figure 3). The time series of soil flutriafol concentrations in the surface 10-cm of soil 

indicates rapid decline after the initial spike resulting from flutriafol applications. This 

observation was not expected because of the high persistence of flutriafol in soil. Nevertheless, 

after the initial spikes and declines, flutriafol concentrations remained steady at an elevated level 

for the duration of the simulation. 

 Day

0 500 1000 1500 2000

Soil Concentration (mg/kg)

0.0

0.2

0.4

0.6

0.8

1.0

1.2

Figure 3: Time Series of Flutriafol Concentrations in Surface Soil (10 cm depth) for the MS 

Soybean Scenario

Additional PRZM modeling was conducted to explain the lack of flutriafol accumulation in the 

surface soil layer in the MS soybean scenario. Table III-3 illustrates the relative contribution of 

probable dissipation process on applied flutriafol over 30 years of PRZM simulation.
35

Table III-3: Contribution of Dissipation Processes for Flutriafol Use on Soybeans in MS 

Compound Percentage of Applied Parent Compound in Leachate, Runoff, Erosion

Leaching Runoff Erosion

Flutriafol 67.060 0.100 0.001

Based on the above analysis, the predicted dominant route of dissipation for flutriafol is leaching 

below the root zone; the contributions from runoff and erosion are much less. These modeling 

data are consistent with observations of flutriafol leaching in field dissipation studies as well as 

laboratory mobility data. 

Although this compound has a partial vapor pressure of 400 nPa 2.5 x 10-8torr at 26°C and a 

Henry’s Law Constant of 1.3 x 10-11 atm x m3 x mol-1, which would indicate a low likelihood for 

dissipation into the atmosphere, it has been observed that long-range atmospheric transport can 

move flutriafol at least as far as the surface of Norwegian ice caps6. 

d. Field Studies 

Dissipation occurred with half-lives between 106 to 13,566 days in terrestrial field studies. This 

is consistent with the submitted, laboratory-derived data. Due to the length of the studies, and 

the persistence of flutriafol, major degradates were not detected in either laboratory or field 

studies. Had these studies been conducted for greater length of time, it is conceivable that 

degradation products may have formed at concentrations greater than ten percent of parent 

equivalents. 

2. Measures of Aquatic Exposure

a. GENEEC2 Exposure Modeling

The Tier I simulation GENEEC2 (Version 2.0; August 1, 2001) is used to determine EECs for 

aquatic exposure resulting from use of flutriafol on terrestrial outdoor sites. GENEEC2 uses a 

standard pond scenario which assumes application of the active ingredient to a 10-hectare 

agricultural field that drains into an adjacent 1-hectare water body, 2 meters deep (20,000 m3

volume) with no outlet. GENEEC2 considers adsorption of the pesticide to soil or sediment, 

incorporation of the pesticide at application, direct deposition of spray drift into the water body, 

and degradation of the pesticide in soil before runoff and within the water body. It is a single 

event model, meaning that it assumes one single large rainfall/runoff event occurs and removes a 

large quantity of pesticide at one time from the field to a pond. The model and information 

about its assumptions are available at the EPA’s water modeling website, 

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

Model input parameters were selected according to standard input guidance and are presented in 

Table III-4. Exposure is estimated based on three use scenarios, in which the chemical is 

assumed by the model to be applied over the entire 10-ha field. Because flutriafol is used in 

 

6

Hermanson, Mark H, et. al, Current-Use and Legacy Pesticide History in the Austfonna Ice Cap, 

Svalbard, Norway, Environmental Science and Technology, 2005, vol. 39, pp. 8163 – 8169.
36

terrestrial outdoor settings, the GENEEC2 model is used to derive Estimated Environmental 

Concentrations (EECs) for the three use scenarios that are assumed to be conservative and likely 

to be representative of exposure occurring in an agricultural setting. 

Table III-4. Summary of Flutriafol Environmental Fate Data Used for the Aquatic Ecological 

Effects Assessment Inputs for Tier I GENEEC Modeling

Fate Property Input Value MRID (or source)

Molecular Weight 301.3

Aqueous Solubility 130 mg/L 

Aqueous Photolysis Half-Life stable 47287601

47090417

Aerobic Soil Metabolism Half- Life stable (time 1⁄2 = 6,932, 840, 1127,

1799, 588, 686, 2205 days)

47090421

47090422

Hydrolysis Half-Life stable 47090416

Aerobic Aquatic Metabolism 

Half-Life (total system)

Stable based on uncertainty in whole 

system data

(water column only = 49.2 days)

90% confidence bound 

calculated in accordance with 

water model input guidance

47090419

Anaerobic Aquatic Metabolism 

Half-Life (benthic)

stable 470090424

Koc 140 (lowest non-sand value) 47090425

47090426

47090427

Application Efficiency

 Apples

 Soybeans

99 percent

99 (ground) and 95 percent (aerial)

EFED Guidance

Crop Management

Maximum Application Rate

 Apples

 Soybeans

0.11 lb. a.i./acre

0.06 lb. a.i./acre

Product Label (67760-TL)

Maximum Number of Applications

 Apples

 Soybeans

4

3

Product Label (67760-TL)

Application Interval

 Apples

 Soybeans

7 days

21 days

Product Label (67760-TL)

Application Method

 Apples

 Soybeans

ground

ground and aerial

Product Label (67760-TL)

Incorporation Depth 0 cm Product Label (67760-TL)

b. GENEEC2 Modeling Results

Aquatic active ingredient EECs generated from GENEEC2 for the labeled uses of flutriafol on 

terrestrial outdoor sites are listed in Table III-5. These results represent peak and 4-, 21-, 60-, 

and 90-day average estimates of surface water concentrations in the standard farm pond for use 

as acute and chronic exposure endpoints. The results for the maximum exposure scenarios, 

appropriate for use in calculating baseline risk quotients, are presented in bold; other values are 

provided for characterization purposes. Model output files for these estimates are in Appendix 

B.1.
37

Table III-5. Surface Water EECs for the Proposed Uses of Flutriafol on Apples and Soybean

Calculated by GENEEC2

Scenario Peak

(μg ai/L)

96 Hour

(μg ai/L)

21 Day 

(μg ai/L)

60 Day 

(μg ai/L)

90 Day 

(μg ai/L)

Ground Spray to Apples 

(0.11 lb ai/A x 4 apps x 7D intervals) 21.2 21.2 21.1 20.9 20.7

Ground Spray to Soybeans

(0.06 lb ai/A x 3 apps x 14D intervals) 8.7 8.7 8.6 8.5 8.5

Aerial Spray to Soybeans

(0.06 lb ai/A x 3 apps x 14D intervals) 10.1 10.1 10.0 10.0 9.9

Ground Spray to Soybeans

(0.06 lb ai/A x 3 apps x 21D intervals) 8.7 8.7 8.6 8.5 8.5

Aerial Spray to Soybeans

(0.06 lb ai/A x 3 apps x 21D intervals) 9.0 9.0 9.0 8.9 8.8

c. PRZM/EXAMs Exposure Modeling

Tier II PRZM/EXAMS modeling was conducted to address aquatic exposure issues for aquatic 

plants. Input parameters for PRZM/EXAMS modeling are shown in Table III-6. Tier II 

estimated environmental concentrations of flutriafol are shown in Table III-7. These results 

represent the 1 in 10 year peak and 4-, 21-, 60-, and 90-day average estimates of surface water 

concentrations in the standard farm pond for use as acute and chronic exposure endpoints. 

Table III-6. Summary of Flutriafol Environmental Fate Data Used for the Aquatic Ecological 

Effects Assessment Inputs for Tier II PRZM/EXAMS Modeling

Fate Property Input Value MRID (or source)

Molecular Weight 301.3

Aqueous Solubility 130 mg/L 

Aqueous Photolysis Half-Life stable 47287601

47090417

Aerobic Soil Metabolism Half- Life 90th percentile of mean = 3247 days

Mean=2025 days

SD=2244 days

N= 7

(time 1⁄2 = 6,932, 840, 1127, 1799,

588, 686, 2205 days)

47090421

47090422

Hydrolysis Half-Life Stable 47090416

Aerobic Aquatic Metabolism 

Half-Life (total system)

100 days for total system half-life 47090419

Anaerobic Aquatic Metabolism 

Half-Life (benthic)

365 days for total system half-life 470090424

Koc 322 (mean Koc) 47090425

47090426

47090427

Application Efficiency

 Apples 99 percent EFED Guidance
38

Crop Management

Maximum Application Rate

 Apples

 

0.11 lb. a.i./acre Product Label (67760-TL)

Maximum Number of Applications

 Apples

 

4 Product Label (67760-TL)

Application Interval

 Apples

 

7 days Product Label (67760-TL)

Application Method

 Apples ground Product Label (67760-TL)

Incorporation Depth 0 cm Product Label (67760-TL)

D. PRZM/EXAMs Modeling Results

Aquatic active ingredient EECs generated from PRZM/EXAMS for the labeled uses of flutriafol

on terrestrial outdoor sites are listed in Table III-7. These results represent peak and 4-, 21-, 60-

, and 90-day average estimates of surface water concentrations in the standard farm pond for use 

as acute and chronic exposure endpoints. The results for the maximum exposure scenario, 

appropriate for use in calculating baseline risk quotients, are presented in bold; other values are 

provided for characterization purposes. Model output files for these estimates are in Appendix 

B.2.

Table III-7. Surface Water EECs for the Proposed Uses of Flutriafol on Calculated by 

PRZM/EXAMS

Scenario Peak

(μg ai/L)

96 Hour

(μg ai/L)

21 Day 

(μg ai/L)

60 Day 

(μg ai/L)

90 Day 

(μg ai/L)

NC Apples 9.88 9.75 9.11 7.92 7.20

OR Apples 3.04 3.02 2.93 2.74 2.61

PA Apples 6.74 6.68 6.26 5.44 4.95

c. Aquatic Exposure Monitoring and Field Data

No monitoring data are available for flutriafol as this is the first registered use in the United 

States.

3. Measures of Terrestrial Exposure

a. Terrestrial Exposure Modeling for Spray Applications
39

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals, 

emphasizing a dietary exposure route for uptake of pesticide active ingredients. These exposures 

are considered as surrogates for terrestrial-phase amphibians as well as reptiles. For exposure to 

terrestrial wildlife, such as birds and small mammals, pesticide residues on food items are 

estimated, based on the assumption that animals are exposed to a single pesticide residue in a 

given exposure scenario. 

For flutriafol spray applications, estimation of pesticide concentrations in wildlife food items 

focuses on quantifying possible dietary ingestion of residues on vegetative matter and insects. 

No field residue data or field study information is available for flutriafol; therefore, the residue 

estimates were based on a nomogram that relates food item residues to pesticide application rate. 

The residue EECs were generated from a spreadsheet-based model (T-REX version 1.3.1) that 

calculates the decay of a chemical applied to foliar surfaces for single or multiple applications, 

and is based on the methods of Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994). 

Uncertainties in the terrestrial EECs are primarily associated with a lack of data on interception 

and subsequent dissipation from foliar surfaces. T-REX does not differentiate between aerial or 

ground applications, the method of application is not considered; thus, the soybean aerial 

scenario is not evaluated. To provide potential exposures to non-target birds and mammals

based on proposed label uses of flutriafol on apples and soybeans, residue EECs were calculated 

using three scenarios: four applications at 0.11 lb ai/A with a 7 day reapplication interval (apple

use), three applications at 0.06 lb ai/A with a 21 day reapplication interval (soybean use to 

control soybean rust), and three applications at 0.06 lb ai/A with a 14 day reapplication interval 

(soybean use to control frogeye leaf spot, cercospora blight and leaf spot, brown spot, and 

powdery mildew). EECs were calculated using a foliar dissipation default half-life of 35 days 

(Willis and McDowell, 1987).

The active ingredient EECs on terrestrial food items may be compared directly with dietary

toxicity data or converted to an oral dose (see Tables III-7 and III-8). The residue concentration 

is converted to daily oral dose based on the fraction of body weight consumed daily as estimated 

through allometric relationships. The risk assessment for flutriafol uses upper bound predicted 

residues as the measure of exposure (Tables III-6, -7, -8); however, mean EECs are also 

presented for characterization purposes.

Table III-6. Terrestrial Dietary-Based EECs (Bird and Mammal) Following Flutriafol Spray Application.

Uses # of App. x App. 

Rate Food Items

Upper Bound EEC1

(mg ai/kg)

Mean EEC2

(mg ai/kg)

Apples

4 applications at 

0.11 lb ai/A with 

7 day intervals

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

86.8

39.8

48.8

5.4

30.7

13.0

16.3

2.5

Soybean

3 applications at 

0.06 lb ai/A with 

14 day intervals

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

33.58

15.39

18.89

2.10

11.89

5.04

6.30

0.98

Soybean

3 applications at 

0.06 lb ai/A with 

21 day intervals

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

30.2

13.8

17.0

1.9

10.7

4.5

5.7

0.9
40

1 Used to determine the potential risk to non-target wildlife and the need to consider regulatory action.

2 Used to further evaluate the likelihood of adverse ecological effects to non-target species.

Table III-7. Terrestrial Dose-Based EECs (Birds) Following Flutriafol Spray Application.

Uses # of App. x 

App. Rate Food items

Avian Classes and Body Weights

small mid large

20 g 100 g 1000 g

Upper Bound EEC (mg ai/kg)1

Apples

4 applications at 

0.11 lb ai/A with 

7 day intervals

Short Grass 98.9 56.4 25.2

Tall Grass 45.3 25.8 11.6

Sm. Insects, 

Broadleaf Plants 55.6 31.7 14.2

Lg. Insects, 

Fruits, Pods 6.2 3.5 1.6

Soybeans

3 applications at 

0.06 lb ai/A with 

14 day intervals

Short Grass 38.25 21.81 9.77

Tall Grass 17.53 10.00 4.48

Sm. Insects, 

Broadleaf Plants 21.51 12.27 5.49

Lg. Insects, 

Fruits, Pods 2.39 1.36 0.61

Soybeans

3 applications at 

0.06 lb ai/A with 

21 day intervals

Short Grass 34.4 19.6 8.8

Tall Grass 15.8 9.0 4.0

Sm. Insects, 

Broadleaf Plants 19.3 11.0 4.9

Lg. Insects, 

Fruits, Pods 2.2 1.2 0.6

Mean EEC (mg ai/kg)2

Apples 4 applications at 

0.11 lb ai/A with 

7 day intervals

Short Grass 35.0 20.0 8.9

Tall Grass 14.8 8.5 3.8

Sm. Insects, 

Broadleaf Plants 18.5 10.6 4.7

Lg. Insects, 

Fruits, Pods 2.9 1.6 0.7

Soybeans

3 applications at 

0.06 lb ai/A with 

14 day intervals

Short Grass 13.56 7.73 3.45

Tall Grass 5.74 3.27 1.46

Sm. Insects, 

Broadleaf Plants 7.18 4.09 1.83

Lg. Insects, 

Fruits, Pods 1.12 0.64 0.28

Soybeans

3 applications at 

0.06 lb ai/A with 

21 day intervals

Short Grass 12.2 7.0 3.1

Tall Grass 5.2 2.9 1.3

Sm. Insects, 

Broadleaf Plants 6.5 3.7 1.6

Lg. Insects, 

Fruits, Pods 1.0 0.6 0.3

1 Used to determine the potential risk to non-target wildlife and the need to consider regulatory action.

2 Used to further evaluate the likelihood of adverse ecological effects to non-target species.
41
42

Table III-8. Terrestrial Dose-Based EECs (Mammals) Following Flutriafol Spray Application.

Uses # of App. x App. 

Rate Food items

Mammal Classes and Body Weights

Herbivores / Insectivores Granivores

small mid large small mid large

15 g 35 g 1000 g 15 g 35 g 1000 g

Upper bound EEC (mg ai/kg)1

Apples

4 applications at 

0.11 lb ai/A with 

7 day intervals

Short Grass 82.76 57.20 13.26

Tall Grass 37.93 26.22 6.08

Sm. Insects, Broadleaf 

Plants 46.55 32.18 7.46

Lg. Insects, Fruits, Pods 5.17 3.58 0.83 1.15 0.79 0.18

Soybeans

3 applications at 

0.06 lb ai/A with 

14 day intervals

Short Grass 32.02 22.13 5.13

Tall Grass 14.68 10.14 2.35

Sm. Insects, Broadleaf 

Plants 18.01 12.45 2.89

Lg. Insects, Fruits, Pods 2.00 1.38 0.32 0.44 0.31 0.07

Soybeans

3 applications at 

0.06 lb ai/A with 

21 day intervals

Short Grass 28.76 19.88 4.61

Tall Grass 13.18 9.11 2.11

Sm. Insects, Broadleaf 

Plants 16.18 11.18 2.59

Lg. Insects, Fruits, Pods 1.80 1.24 0.29 0.40 0.28 0.06

Mean EEC (mg ai/kg)2

Apples

4 applications at 

0.11 lb ai/A with 

7 day intervals

Short Grass 29.31 20.26 4.70

Tall Grass 12.41 8.58 1.99

Sm. Insects, Broadleaf 

Plants 15.52 10.73 2.49

Lg. Insects, Fruits, Pods 2.41 1.67 0.39 0.54 0.37 0.09

Soybeans

3 applications at 

0.06 lb ai/A with 

14 day intervals

Short Grass 11.30 7.85 1.78

Tall Grass 4.79 3.32 0.76

Sm. Insects, Broadleaf 

Plants 5.98 4.16 0.94

Lg. Insects, Fruits, Pods 0.93 0.65 0.15 0.21 0.15 0.03

Soybeans

3 applications at 

0.06 lb ai/A with 

21 day intervals

Short Grass 10.15 7.05 1.60

Tall Grass 4.30 2.99 0.68

Sm. Insects, Broadleaf 

Plants 5.37 3.73 0.85

Lg. Insects, Fruits, Pods 0.84 0.58 0.13 0.18 0.13 0.03

1 Used to determine the potential risk to non-target wildlife and the need to consider regulatory action.

2 Used to further evaluate the likelihood of adverse ecological effects to non-target species.
43

TerrPlant, a Tier I model, predicts EECs for terrestrial plants located in dry and semi-aquatic areas 

adjacent to the treated field. The active ingredient EECs are based on the application rate, soil 

incorporation, runoff fraction, drift fraction and solubility of the pesticide in water and drift 

characteristics, which depend on ground and aerial applications. The amount of flutriafol that runs 

off is a proportion of the application rate and is assumed to be 5% based on flutriafol’s solubility

of >100 mg/L in water. Drift from ground and aerial applications are assumed to be 1% and 5%, 

respectively, of the application rate. An application efficiency of 100% is assumed for aerial 

application. For this terrestrial exposure assessment, ground and aerial application methods to 

plants for flutriafol are considered in TerrPlant, which adds the third exposure scenario – 1 aerial 

application at 0.06 lb ai/A according the label for soybean use which permits aerial applications.

For a standard scenario on an agricultural field when applications are occurring on land, EFED’s 

runoff scenario for terrestrial plants inhabiting dry areas adjacent to a field is characterized as 

“sheet runoff” (one treated acre to an adjacent acre: a 1:1 ratio) and inhabiting semi-aquatic or 

wetland areas adjacent to a field is characterized as “channelized runoff” (10 treated acre to a 

distant low-lying acre: a 10:1 ratio). Details of the TerrPlant model and EECs are presented in 

Table III-9 and in Appendix E.

TABLE III-9. EECs for Terrestrial Plants Located Adjacent to Flutriafol (broadcast spray application) 

Treated Sites. 

Terrestrial Use

Application 

Method

(Non-granular)

Concentration (lbs ai/A)

Total Loading to 

Areas Adjacent to 

Treated Areas1

Total Loading to SemiAquatic Areas Adjacent 

to Treated Areas2

Drift to 

Adjacent Areas3

Apples

(0.11 lb ai/A) Ground Unincorp. 4

0.0066 0.0561 0.0011

Soybean

(0.06 lb ai/A)

Ground Unincorp.

Aerial

0.0036

0.006

0.0306

0.033

0.0006

0.003

1 EEC = Sheet Runoff + Drift (1% for ground; 5% for aerial)

2 EEC = Channelized Runoff + Drift (1% for ground; 5% for aerial)

3 EEC for ground (appl. rate x 1% drift); for aerial (appl. rate x 5% drift)

4 EEC for Unincorporated Ground Spray Application

4. Measures of Incidental Spray Drift Exposure 

Exposure estimates from spray drift are generated using the AgDRIFT (ver 2.0.1) model, which 

predicts spray drift (or ‘acute’) EECs for non-target terrestrial and aquatic animals and aquatic 

plants exposed immediately to the toxicity of the formulated product as a whole by incidental 

application as a result of drift. Exposure modeling for spray drift EECs is limited to situations, as 

in this case for flutriafol, where available data indicate that the formulated product is more toxic to 

aquatic animals and plants than the technical grade active ingredient.

The limitation on the quantitative exposure modeling for formulations is based on the expectation 

that the varying physical-chemical properties of individual components of pesticide formulations 

will result in progressively different formulation constituents in the environmental media over 

time. As the proportions of formulation components in the environmental media differ from the 

proportions in the tested formulation, the assumption that environmental residues are 

toxicologically equivalent to tested formulations cannot be supported beyond the time period 
44

immediately following product application. For terrestrial biota, exposure modeling is limited to 

dietary exposure to residues for a time period immediately following product application, while 

exposure modeling for aquatic biota is limited to direct introduction of the formulation to surface 

waters immediately following application. Spray drift (or ‘acute’) EECs are presented in Table 

III-10.

EECs generated from AgDRIFT for the labeled uses of Flutriafol 125 g/L SC on terrestrial outdoor 

sites are listed in Table III-9. These results represent estimates of spray drift concentrations to 

non-target areas adjacent to treated areas immediately following a single application. Since the 

AgDRIFT EECs are used as ‘acute’ exposure endpoints in the assessment, no chronic exposure 

endpoints (from spray drift or runoff) are available for the formulated product. For agricultural 

applications, spray drift was estimated based on the default assumptions that 5% of the application 

rate of the formulation reaches the adjacent sites for aerial spray and 1% of the application rate for 

ground spray. The results for the maximum exposure scenario, appropriate for use in calculating 

baseline risk quotients, are presented in bold; other values are provided for characterization 

purposes.

Table III-10. Spray Drift EECs for the Proposed Flutriafol 125 g/L SC Uses on Apples and 

Soybean Calculated by AgDRIFT.

Scenario

Application Rate

(lbs formulated 

product/A)

Application Method

(ground or aerial)

Acute EEC from Spray 

Drift 

(μg form/L)

Apples 0.92 Ground 1.4

Soybeans

0.5 Ground 0.77

0.5 Aerial 3.6

C. Ecological Effects Characterization 

Ecological effects studies have been submitted for flutriafol (technical grade: EPA Reg. No. 4787-

LL) and the flutriafol formulated product, Flutriafol 125 g/L SC. In the ecological effects 

characterization section and in Appendix F, all exposure concentrations and toxicity values are 

expressed based on the active ingredient (a.i.) and its formulated product (form). 

Following implementation of the Overview document (USEPA, 2004a), EFED has begun 

incorporating data from open literature into ecological risk assessments (USEPA, 2004b). 

Toxicity data from open literature are identified via the ECOTOX search engine and maintained by

EPA/ORD. In order to be included in the ECOTOX database, papers must meet the following 

minimum criteria:

 the toxic effects are related to a single chemical exposure;

 the toxic effects are on an aquatic or terrestrial plant or animal species;

 there is a biological effect on live, whole organisms;
45

 a concurrent environmental chemical concentration/dose or application rate is reported; and

 there is an explicit duration of exposure.

Data that passes the ECOTOX screen is evaluated along with the registrant-submitted data, and 

may be incorporated qualitatively or quantitatively into the risk assessment. In general, effects 

data in the open literature that are less than, more conservative than, or surrogates the registrantsubmitted data are considered. The degree to which open literature data is quantitatively or 

qualitatively characterized is dependant on whether the information is relevant to the assessment 

endpoints (i.e., maintenance of survival, reproduction, and growth) identified in the problem 

formulation. For example, endpoints such as behavior modifications are likely to be qualitatively

evaluated, because it is unclear whether such modifications cause a reduction in species survival, 

reproduction, and/or growth. Specific open literature data that are considered include the 

following:

(1) the endpoint is more sensitive than those identified in the registrant data;

(2) the data is for under represented taxa (i.e., amphibians); 

(3) the data includes endpoints not normally evaluated in registrant studies, but 

ecologically relevant; and 

(4) the data surrogates the missing/unavailable registrant data.

A search for open literature (ECOTOX) data on flutriafol did not produce any results even though 

flutriafol has been registered in other countries with previously generated toxicity, effects, and fate 

studies; therefore, the data in the risk assessment are based on the studies submitted by the

registrant. A summarized table of toxicity endpoints selected for aquatic and terrestrial risk 

assessment can be found in Tables IV-4, IV-5 and IV-12.

1. Aquatic Effects Characterization 

a. Aquatic Animals 

(1) Acute Effects 

Freshwater Fish, Acute

Fish toxicity studies for two freshwater species using the technical grade active ingredient (TGAI)

are required to establish the acute toxicity of flutriafol to fish. The preferred test species are 

rainbow trout (a coldwater fish) and bluegill sunfish (a warm water fish). Acute studies submitted 

for the trout and sunfish categorize the TGAI as slightly toxic to freshwater fish on an acute 

toxicity basis. Results of the acute studies with freshwater fish indicate bluegill sunfish is more 

sensitive to the TGAI than rainbow trout; therefore, the sunfish LC50 value of 33 mg ai/L with the 

TGAI is used to evaluate potential acute effects of the TGAI to freshwater fish. 

In addition, the registrant provided supplement acute studies with these freshwater species using 

the formulated product of flutriafol, Flutriafol 125 g/L SC. The lowest freshwater fish 96-h LC50

for Flutriafol 125 g/L SC is 7.9 mg form/L, The study authors suggest the high toxicity of flutriafol 

in the formulated end use product to fish is primarily due to the toxicity of inerts, not the AI, in the 

formulation. The guideline requirement for acute freshwater fish toxicity (MRIDs 47090310, 

47090311, 47090312), with the exception of the sunfish with Flutriafol 125 g/L SC (MRID 
46

47090309), fulfills the OPPTS 850.1075 test guideline for acute toxicity of flutriafol to freshwater 

fish. The available freshwater fish toxicity data for flutriafol is discussed below and summarized in 

Table III-11.

Table III-11. Freshwater Fish Acute Toxicity with Flutriafol TGAI and Flutriafol 125 g/L SC

Species % ai 96-hour

LC50 (mg ai/L)

Toxicity 

Category

MRID No.

Author/Year

Study 

Classification

Flutriafol TGAI

Rainbow trout

(Oncorhynchus mykiss)

93 52.3 ASlightly toxic

47090311

Hill, R.W. (1982) Acceptable

Bluegill sunfish

(Lepomis macrochirus)

93 33 BSlightly toxic 47090310

Hill, R.W. (1985) Acceptable

Flutriafol 125 g/L SC

Rainbow trout

(Oncorhynchus mykiss)

11.6 7.9 mg form/L N/A 47090312

Sankey (1993) Acceptable

Bluegill sunfish

(Lepomis macrochirus)

11.9 20 mg form/L N/A

47090309

Palmer, Sutherland, and 

Kendall (2007)

Supplemental 1

A Trout 95% Confidence Interval = 45.3-58.9 mg ai/L; probit slope = N/A (binomial method)

B Sunfish 95% Confidence Interval = 23-44 mg ai/L; probit slope and 95% C.I. = 4.04 (1.99-6.09)

1 Does not satisfy the OPP guideline requirement for an acute freshwater fish toxicity study with the formulated

product, Flutriafol 125 g/L SC, but does provide useful information that suggest the high toxicity of flutriafol in the 

formulated end use product to fish is primarily due to the toxicity of the formulation inerts, not the active ingredient 

component of the formulation. Despite the supplemental classification because an EC50 could not be established for 

the formulation inerts, the data are considered useful for characterizing the aquatic toxicity profile of the formulation 

inert ingredients relative to the active ingredient (i.e., the formulation ingredients are more toxic to fish than the 

active ingredient at an amount equal to the highest dose used in the study).

Aquatic-phase Amphibians

No amphibian toxicity studies were submitted or located in the open literature. Consequently, the 

freshwater fish toxicity data are used as a surrogate for aquatic-phase amphibian species, and 

toxicity between taxa is assumed to be similar.

Freshwater Invertebrates, Acute

A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the acute 

toxicity of flutriafol to aquatic invertebrates. The preferred test species is Daphnia magna, a water 

flea. Submitted data indicate the TGAI is categorized as no more than slightly to slightly toxic to 

Daphnia magna with acute 48-hour EC50s of 67.1 and >63.5 mg ai/L (Table III-12). Results of the 

acute studies with freshwater invertebrates indicate the daphnid EC50 value of 67.1 mg ai/L with 

the TGAI is used to evaluate potential acute effects of the TGAI to freshwater invertebrates.

In addition, the registrant provided supplement acute toxicity data with Daphnia magna using 

Flutriafol 125 g/L SC, a flutriafol formulated product. The 96-h LC50 for the formulated product

based on immobility is 7.05 mg form/L. Similar to fish, the study authors suggest the greater

toxicity of AI in the formulated product to invertebrates is primarily due to the toxicity of inerts,
47

not the AI, in the formulation. The guideline requirement (OPPTS 850.1010) for acute invertebrate 

toxicity is fulfilled (MRIDs 47090304, 47090305). The available freshwater invertebrate toxicity

data is discussed and summarized in Table III-12, below.

Table III-12. Freshwater Invertebrate Acute Toxicity with Flutriafol TGAI and Flutriafol 125 

g/L SC

Species % ai 48-hour EC50

(mg ai/L)

Toxicity 

Category

MRID No.

Author/Year

Study 

Classification

Flutriafol TGAI

Water flea

(Daphnia magna) 93.0

>63.5 No more than 

slightly toxic 47090304

Hamer and Hill. 1982.

Acceptable

67.1ASlightly toxic Acceptable

Flutriafol 125 g/L SC

Water flea

(Daphnia magna)

11.8 7.05 mg form/L N/A 47090305

Kent, S. 1994. Acceptable

A Daphnid 95% Confidence Interval = 58.8-78.0 mg ai/L; Probit slope (95% C.I.) = 5.43 (3.41-7.45)

Estuarine/Marine Fish, Acute

Acute toxicity testing with estuarine/marine fish using the TGAI is required for flutriafol because 

the end-use product may be applied directly to water and/or is expected to reach this environment 

due to its potential use in coastal areas where apples are grown. An acute toxicity study with the 

TGAI (Table III-13) was performed with the preferred test species, sheepshead minnow. The 

TGAI 96-hour LC50 is >72.2 mg ai/L, the highest concentration tested, respectively; therefore, the 

AI is categorized as no more than slightly toxic to estuarine/marine fish on an acute basis. No 

acute toxicity data with estuarine/marine fish tested with the formulated product, Flutriafol 125

g/L, is available. The OPPTS guideline 850.1075 for estuarine/marine fish is fulfilled (MRID 

47090308).

Acute studies with estuarine/marine fish using the formulated product were not submitted; 

therefore, the toxicity of the product itself to estuarine/marine fish from acute exposure to the 

formulated product (Flutriafol 125 g/L SC) is uncertain. An acute to acute ratio (AAR) value 

derived from different fish species are used to estimate the acute toxicity value of the product itself

to estuarine/marine fish because valid acute LC50 values are available for calculation (see below). 

The estimated LC50 is >17 mg form/L. There is uncertainty associated with the estimated LC50 for

the product because the acute toxicity data do not allow for a definitive determination of the 

relative sensitivity of freshwater and estuarine/marine fish.

1) Sunfish acute value of the TGAI = 33 mg ai/L = 36 (AAR)

Sunfish acute value of the AI in the product 0.92 mg ai/L

2) Sheepshead minnow acute value of TGAI = >72.2 mg ai/L = >2 mg ai/L (estimated acute value of 

AAR 36 AI in the product)

2a) Sheepshead minnow acute value of formulated product = >2 mg ai/L (estimated) / 11.9% = >17 mg form/L 
48

The available estuarine/marine fish toxicity data is summarized in Table III-13.

Estuarine and Marine Invertebrates, Acute

Acute toxicity testing with estuarine/marine invertebrates using the TGAI is required for flutriafol 

because the end-use product may be applied directly to water and/or is expected to reach this 

environment due to its potential use in coastal areas where apples are grown. The preferred test 

species are mysid shrimp and Eastern oyster. Studies with Eastern oyster and mysid shrimp show 

that the TGAI is categorized as slightly toxic to these species (Table III-14) on an acute basis. No 

acute toxicity data with estuarine/marine invertebrates tested with the formulated product are 

available. Results of the acute studies with estuarine/marine invertebrates indicate mollusk is more 

sensitive to the TGAI than shrimp; consequently, the TGAI EC50 value of 25 mg ai/L for Eastern 

oyster is used to evaluate potential acute effects of the AI to estuarine/marine invertebrates. The 

OPPTS guidelines 850.1025 and 850.1035 for mollusks and shrimp are fulfilled (MRIDs 

47090306 and 47090307). 

Acute studies with the formulated product on estuarine/marine invertebrates were not submitted; 

therefore, the acute toxicity values of the AI in its formulated product and the product itself to 

estuarine/marine invertebrates from acute exposure to the formulated product (Flutriafol 125 g/L 

SC) are uncertain. Acute to acute ratio (AAR) derived from different invertebrate species are

employed to estimate the acute toxicity value of the product itself to estuarine/marine invertebrates 

because valid acute LC50 values are available for calculation. Based on calculations (see below), 

the estimated EC50 is 2.5 mg form/L. There is uncertainty associated with the estimated EC50 of the 

product for estuarine/marine fish because the acute toxicity data do not allow for a definitive 

determination of the relative sensitivity of freshwater and estuarine/marine invertebrates.

1) Daphnid acute value of the TGAI = 67.1 mg ai/L = 80 (AAR)

Daphnid acute value of the AI in the product 0.83 mg ai/L

2) Oyster acute value of TGAI = 25 mg ai/L = 0.3 mg ai/L (estimated acute value of AI in the product)

AAR 80 

2a) Estuarine/marine invertebrate acute value of formulated product = 0.3 mg ai/L (estimated) / 11.9% = 2.5 mg 

Table III-13. Estuarine/Marine Fish Acute Toxicity with Flutriafol TGAI and Flutriafol 125 g/L SC

Species % ai

96-hour LC50 

(mg ai/L)

Toxicity 

Category

MRID No.

Author/Year

Study 

Classification

Flutriafol TGAI

Sheepshead minnow

(Cyprinodon 

variegatus)

95.1 >72.2*

No more 

than slightly 

toxic

47090308

Palmer, Sutherland, 

Kendall, Krueger. 2006.

Acceptable

Flutriafol 125 g/L SC

Estuarine/marine Fish N/A >17 mg form/L N/A AAR N/A

* The LC50 was greater than the highest concentration; therefore, it was not possible to produce a probit slope and 95% confidence 

intervals.

N/A – Not applicable

AAR – Acute to acute ratio using freshwater fish data with TGAI alone and the AI value of the formulated product x 11.9%.
49

form/L (estimated) 

The available estuarine/marine invertebrate toxicity data for flutriafol are discussed below and 

summarized in Table III-14.

Table III-14. Estuarine/Marine Invertebrate Acute Toxicity with Flutriafol TGAI and Flutriafol 125 

g/L SC

Species % ai.

96-hour

LC50/EC50

(mg ai/L)

Toxicity 

Category

MRID No.

Author/Year

Study 

Classification

Flutriafol TGAI

Eastern oyster

(shell deposition)

(Crassostrea virginica)

95.1 EC50 = 25

A

Slightly toxic

47090306

Palmer, Sutherland, 

Kendall, and Krueger. 

2006.

Acceptable

Mysid

(Americamysis bahia) 95.1 LC50 = 34.9 B

Slightly toxic

47090307

Palmer, Sutherland, 

Kendall, and Krueger. 

2006.

Acceptable

Flutriafol 125 g/L SC

Estuarine/marine 

Invertebrate N/A 2.5 mg form/L N/A AAR N/A

A Oyster 95% Confidence Interval = 17-38 mg ai/L; Probit slope (95% C.I.) = 2.14 (0.9 – 3.74 (estimated))

B

 Mysid 95% Confidence Interval = 30.8-47.2 mg ai/L; Probit slope (95% C.I.) = N/A (binomial method). 

N/A – Not applicable

AAR – Acute to acute ratio using freshwater invertebrate data with TGAI alone and the AI value of its formulated product.

(2) Chronic Effects 

Freshwater Fish, Chronic

A freshwater fish early life-stage test using the TGAI is required to establish the chronic toxicity of 

flutriafol to fish. The preferred test species is fathead minnow. EFED will use this TGAI NOAEC 

value of 4.8 mg ai/L to evaluate potential chronic effects of the AI to freshwater fish. The OPPTS 

850.1400 guideline is fulfilled (MRID 47090317). The available freshwater fish early life-stage

toxicity data is discussed below and summarized in Table III-15. Chronic fish data with the 

formulated product of flutriafol are not available.
50

Table III-15. Freshwater Fish Early Life-Stage Toxicity with Flutriafol TGAI and Flutriafol 125 g/l 

SC

Species % ai NOAEC 

(mg ai/L)

LOAEC 

(mg ai/L)

Endpoints 

Affected

MRID No.

Author/Year

Study 

Classification

Flutriafol TGAI

Fathead minnow

(Pimephales 

promelas)

95.1 4.8 9.5

Larval survival, 

clinical signs of 

toxicity, terminal 

growth

47090317

Palmer, Kendall, 

and Krueger. 2007.

acceptable

Flutriafol 125 g/L SC

Freshwater Fish N/A No Data No Data N/A No Data N/A

N/A – not applicable 

Freshwater Invertebrate, Chronic

A freshwater aquatic invertebrate life-cycle test using the TGAI is required to establish the chronic 

toxicity of flutriafol to freshwater invertebrates. The preferred test is a 21-day life cycle on 

Daphnia magna. EFED will use the lowest NOAEC of 0.31 mg ai/L to evaluate potential chronic 

effects of the AI to freshwater invertebrates.

In addition, the registrant provided chronic toxicity data with Daphnia magna using the formulated

product of flutriafol. The NOAEC value of the AI in the formulated product is 0.013 mg ai/L. 

Again, the study authors suggest the greater toxicity of flutriafol in the formulated end use product 

to invertebrates is primarily due to the toxicity of inerts, not the AI, in the formulation. The 

OPPTS guideline 850.1400 is fulfilled for MRID 47090314 but not fulfilled for MRID 47090315 

and 47090316. The available freshwater invertebrate life cycle data is discussed below and 

summarized in Table III-16 and Appendix F.

Table III-16. Freshwater Aquatic Invertebrate Life-Cycle Toxicity with Flutriafol TGAI and Flutriafol 125 

g/L SC

Species % 

ai

NOAEC 

(mg ai/L)

LOAEC 

(mg ai/L)

Endpoints 

Affected

MRID No.

Author/Year

Study 

Classification

Flutriafol TGAI

Water flea

(Daphnia magna)

95.5 0.31 0.55 Length, offspring 

per adult

47090314

Williams et al. 1990. Acceptable

94.4 1.0 3.2 Adult survival, 

offspring per adult

47090315

Bätscher. 2004. Supplemental1

Flutriafol 125 g/L SC

Water flea

(Daphnia magna) 12.5 0.1 mg 

form/L 0.34 Larval survival, offspring per adult

47090316

Batscher, R. 2004. Supplemental1

1 Not all test solutions from each treatment level were analyzed. The author reported that only the biologically 

relevant levels were analyzed. 

Estuarine and Marine Fish and Invertebrates, Chronic

Chronic TGAI studies on estuarine/marine fish and invertebrates were not submitted; therefore, the 

toxicity of the TGAI to estuarine/marine species from chronic exposure to flutriafol is uncertain. 
51

Therefore, acute to chronic ratios (ACRs) derived from different fish or invertebrate species are

employed to estimate the chronic toxicity of the TGAI to estuarine/marine fish and invertebrates 

because valid acute EC50 and chronic NOAEC values are available for calculation. There is 

uncertainty associated with the estimated chronic NOAEC for estuarine/marine fish and 

invertebrates because the acute toxicity data with the TGAI do not allow for a definitive 

determination of the relative sensitivity of freshwater and estuarine/marine fish or invertebrates. In 

addition, there are no chronic studies on estuarine/marine fish and invertebrates with the 

formulated product, Flutriafol 125 g/L SC.

A fish acute to chronic ratio analysis was used to determine the estuarine/marine fish chronic value 

(NOAEC) of the TGAI. The NOAEC is >11 mg ai/L. 

1) Sunfish acute value = 33 mg ai/L = 6.9

 Fathead minnow chronic value 4.8 mg ai/L

2) Sheepshead minnow acute value = >72.2 mg ai/L (actual) = >11 mg ai/L (estimated chronic value)

 ACR 6.9

An invertebrate acute to chronic ratio analysis is used to determine the estuarine/marine 

invertebrate chronic value (NOAEC) of the TGAI. The NOAEC is 0.16 mg ai/L. 

1) Daphnid acute value = 67.1 mg ai/L = 216

 Daphnid chronic value 0.31 mg ai/L

2) Mysid acute value = 34.9 mg ai/L (actual) = 0.16 mg ai/L (estimated chronic value)

 ACR 216 

There is uncertainty associated with the estimated NOAEC values of the AI for estuarine/marine

organisms because if submitted chronic toxicity data with the product is lower or higher than the 

estimated value, the toxicity of the AI to estuarine/marine organisms might be under- or overestimated, respectively.

In summary, when an ACR or a factor estimated toxicity value is used for risk quotient 

calculations, this does not replace the data gap and cannot be used to satisfy any OPP guidelines.7

An ACR analysis is used as a tool to determine the need for additional testing to address the data 

gap or uncertainty. 

(3) Sublethal Effects 

Sublethal effects observed in the acute aquatic animal studies included loss of equilibrium, 

lethargy, surfacing, erratic/ceased swimming, quiescence, sounding, dark discoloration, 

irregular/labored/rapid respiration, coughing, swelling in gut area, and lying on bottom at 

concentrations higher than observed for mortality or immobilization. In addition to acute studies, 

the sublethal effects observed in the chronic studies were production of young daphnids by first 

generation parents, growth in daphnids and reproduction and growth in fish.

 

7 EFED memorandum dated June 7 2005, “Use of Acute-to-Chronic Ratios in Support of Ecological Risk Assessment of 

Pesticides.”
52

 

(4) Field Studies 

No field studies were submitted or identified in the open literature for use in this assessment.

b. Aquatic Plants 

Aquatic plant toxicity studies (Table III-17) using the TGAI or TEP are required to establish the 

toxicity of flutriafol to non-target aquatic plants. The registrant submitted TEP Tier II testing with

five species; the species are freshwater green alga (Pseudokirchneriella subcapitata), duckweed 

(Lemna gibba), marine diatom (Skeletonema costatum), blue-green algae (Anabaena flos-aquae), 

and a freshwater diatom. Of the four non-vascular species tested with the formulated product

(TEP), the marine diatom is the most sensitive non-vascular plant. Results with one vascular 

species and four nonvascular species indicate that non-vascular species are more sensitive to the 

formulated product containing flutriafol than vascular species. The 14-day EC50 for the vascular 

plant (duckweed) is 0.78 mg ai/L (EC05 = 0.018 mg ai/L), based on biomass; and the lowest 4-day

EC50 for the non-vascular plant (marine diatom) is 0.46 mg ai/L (NOAEC = 0.1 mg ai/L), based on 

biomass. These aquatic plant toxicity studies (MRIDs 47090330, 47090331, 47090332, 47090333, 

47090334) are scientifically sound for a formulated product; however, they do not satisfy the 

OPPTS 850.5400 guideline requirement for a Tier II freshwater alga toxicity study. These studies 

are classified as supplemental because data were not available to establish an EC50 for the 

formulation inerts. However, the studies provide useful information suggesting that the toxicity of 

the AI in the formulated product to freshwater vascular plants and algae is primarily due to the 

formulation inerts, not the active ingredient in the formulation. Despite the supplemental 

classification because an EC50 could not be established, the data are considered useful for 

characterizing the aquatic toxicity profile of the formulation inert ingredients relative to the active 

ingredient (i.e., the formulation ingredients are more toxic to fish than the active ingredient at an 

amount equal to the highest dose used in the study). The available aquatic plant toxicity studies are 

discussed below and summarized in Table III-17.
53

Table III-17. Toxicity of Flutriafol 125 g/L SC (formulated product) to Nontarget Aquatic Plants - Tier II

Species % ai EC50 NOAEC MRID No.,

Author/Year

Study 

Classification

Flutriafol 125 g/L SC

Vascular Plant- Duckweed

Lemna gibba 11.9

0.78 mg ai/L

(6.6 mg form/L)

0.018 A mg ai/L

(0.15 mg form/L)

47090330

Desjardins, Kendall, and 

Krueger. 2006.

Supplemental1

Non-Vascular Plant- marine 

diatom

Skeletonema costatum

11.9

0.46 mg ai/L

(3.4 mg form/L)

0.1 mg ai/L

(0.84 mg form/L)

47090331

Desjardins, Kendall, and 

Krueger. 2006.

Supplemental1

Non-Vascular Plant- freshwater 

diatom

Navicula pelliculosa

11.9 1.0 mg ai/L 0.35 mg ai/L

47090332

Desjardins, Kendall, and 

Krueger. 2006.

Supplemental1

Non-Vascular Plant- freshwater 

green algae

Pseudokirchneriella subcapitata

11.9 0.6 mg ai/L 0.24 A mg ai/L

47090333

Desjardins, Kendall, and 

Krueger. 2007.

Supplemental1

Non-Vascular Plant- freshwater 

blue-green algae

Anabaena flos-aquae

11.9 14 mg ai/L 2.9 mg ai/L

47090334

Desjardins, Kendall, and 

Krueger. 2007.

Supplemental1

A Based on the EC05 because the NOAEC was determined to be lower than the lowest test concentration.

1 Data were not available to establish an EC50 for the formulation inerts.

2. Terrestrial Effects Characterization 

a. Terrestrial Animals 

(1) Acute Effects 

Birds – acute oral

An acute oral toxicity study using the technical grade of the active ingredient (TGAI) is required to 

establish the acute toxicity of flutriafol to birds. The preferred guideline non-passerine test species 

is either mallard duck (a waterfowl) or Northern bobwhite quail (an upland game bird), and a 

passerine bird. The registrant submitted data with mallard duck, bobwhite quail, and red-legged 

partridge to establish the acute toxicity of flutriafol TGAI to birds. No data with a passerine bird 

has been submitted to establish the toxicity of flutriafol TGAI to passerine birds. The submitted 

acute data indicate that the TGAI is categorized as slightly toxic to upland game birds and 

practically non-toxic to waterfowl with oral LD50 values of 616 - 810 and >5000 mg a.i./kg bw, 

respectively (Table III-18). Results of the acute oral studies with birds indicate the red-legged 

partridge is more sensitive to the TGAI than the mallard duck and likely the quail; therefore, the 

partridge LD50 value of 616 mg ai/kg-bw is used to evaluate potential acute effects of the TGAI to 

birds via the oral route. Without data on a passerine bird, the guideline requirement (OPPTS 

850.2100) is not fulfilled for acute oral toxicity to birds exposed to the TGAI. The duck (MRID 

47090318) and quail (MRID 47471301) studies are classified as acceptable; the partridge study

(MRID 47090319) is classified as supplemental because mortality of 5% or more occurred during 

the acclimation period. The description and classification of the available avian acute oral toxicity

data are discussed below and summarized in Table III-18. No avian acute oral toxicity data with 

the formulated product of flutriafol are available.
54

Table III-18. Avian Acute Oral Toxicity with Flutriafol TGAI

Species % ai LD50

(mg ai/kg bw)

Toxicity 

Category

MRID No.

Author/Year

Study

Classification

Passerine bird No data No data No data No data No data

Red-legged partridge

(Alectoris rufa) 93 616A Slightly 

toxic

47090319

Roberts and Fairley. 1982. Supplemental1

Mallard duck

(Anas platyrhynchos)

93 >5000 B Practically 

nontoxic

47090318

Roberts and Fairley. 1982. Acceptable

Northern bobwhite 

quail

(Colinus virginianus)

95.1 810

Slightly 

toxic

47471301

Hubbard and Beavers. 2008. Acceptable

A

 Partridge 95% Confidence Interval = 342-1108 mg ai/kg bw; Probit slope = N/A (binomial method)

B A probit slope along with 95% confidence intervals could not be calculated due to lack of a concentration-response 

relationship.

1

>5% mortality occurred during acclimation 

Birds – subacute dietary

Two dietary studies using the TGAI are required to establish the subacute toxicity of flutriafol to 

birds. The preferred test species are mallard duck (waterfowl) and bobwhite quail (upland game 

bird). The submitted data indicate the 8-day acute dietary LC50 for duck and quail to be 4062 and 

6352 mg ai/kg diet, respectively. Therefore, the TGAI is categorized as slightly toxic to waterfowl 

and practically non-toxic to upland game birds on a subacute dietary basis (Table III-19). Results 

of the acute dietary studies with birds indicate the mallard duck is more sensitive to flutriafol

TGAI than the bobwhite quail; therefore, the duck LD50 value of 4062 mg ai/kg-diet is used to 

evaluate potential acute effects of the TGAI to birds via the dietary route. The guideline (OPPTS 

850.2200) is fulfilled for a subacute dietary study with birds. The description and classification of 

the available avian subacute dietary studies are discussed below and summarized in Table III-19

and Appendix F. No avian subacute dietary toxicity data with the formulated product of flutriafol 

are available.

Table III-19. Avian Subacute Dietary Toxicity with Flutriafol TGAI

Species % ai 10-Day LC50

(mg ai/kg-diet)

Toxicity 

Category

MRID No.

Author/Year

Study 

Classification 

Northern bobwhite quail

(Colinus virginianus) 93 6352 A Practically nontoxic

47090321

Roberts. 1986.

Acceptable

Mallard duck

(Anas platyrhynchos)

93 4062 BSlightly toxic

47090320

Roberts, Fairley, and 

Almond. 1982.

Acceptable

A Quail 95% Confidence Interval = 5240-7700 mg ai/kg-diet; probit slope = N/A (binomial method)

B Duck 95% Confidence Interval = 2985-5521 mg ai/kg-diet; probit slope = N/A (binomial method)

Mammals

Wild mammal testing is required on a case-by-case basis, depending on the results of lower Tier

laboratory mammalian studies, intended use pattern and pertinent environmental fate 

characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's Health 

Effects Division (HED) substitute for wild mammal testing. These toxicity values are reported 
55

below in Table III-20 and summarized in Appendix F.

The results indicate that the TGAI is categorized as moderately to slightly toxic (LD50 range = 179 

– 1480 mg/kg-bw) to small mammals, while its formulated product is not toxic (LD50 >2000 mg 

form/kg) to rat on an acute oral basis. Results of the TGAI acute oral studies with mammal 

indicate the mouse is more sensitive to flutriafol than the rat; therefore, the mouse TGAI LD50

value of 179 mg ai/kg-bw; as well as, the rat formulated product LD50 value of >2000 mg form/kgbw, are used to evaluate potential acute effects to mammals.

Table III-20. Mammalian Acute Toxicity for Flutriafol TGAI and Flutriafol 125 g/L SC. 

Species % ai Test Type

LD50

(mg ai/kg bw)

Affected 

Endpoints

MRID No.

Author, Year

Toxicity 

Category

Flutriafol TGAI

Rat

(Sprague-Dawley)

93 acute oral

Male = 1140 1

Females = 1480 

LD50 Combined 

> 1000 and < 

1500 

Mortality

47090335

Slightly toxic

Mouse

(Mus musculus)

Males = 365 2

Females = 179 

LD50 Combined 

not reported

Mortality Moderately 

toxic

Flutriafol 125 g/L SC

Rat 11.9 acute oral

LD50 Males and 

Females: >2000 

mg form/kg-bw

Mortality 47090003 Practically 

nontoxic

1Male (95% Confidence Limits 880-1470 mg/kg bw); Female (95% Confidence Limits 1090-1980 mg/kg bw)

2 Male (95% Confidence Limits 312-434 mg/kg bw); Female (95% Confidence Limits could not be calculated)

Reptiles and Terrestrial-phase Amphibians

No amphibian or reptile toxicity studies were submitted or located in the open literature.

Consequently, the avian toxicity data are used as a surrogate for terrestrial-phase amphibian and 

reptilian species, and toxicity between taxa is assumed to be similar.

Beneficial Insects

A honeybee acute contact study using the TGAI is required for flutriafol because its use as a 

fungicide treatment use will result in honeybee exposure (Table III-21). The acute contact LD50, 

using the honey bee, Apis mellifera, is derived from a laboratory study designed to estimate the 

quantity of toxicant required to cause 50% mortality in a test population of bees. The contact 48-h 

LD50 is >50 μg ai/bee for the TGAI. In addition, the registrant provided acute contact studies using 

the formulated product of flutriafol. The lowest contact 48-h LD50 for the formulation is >10.5 μg 

ai/bee. Results of the acute contact studies with honeybees indicate the TGAI and formulated 

product of flutriafol are practically non-toxic to bees on a contact exposure basis. The guideline 

(OPPTS 850.3020) is fulfilled. The contact tests (MRIDs 47090326, 47090327) are classified as 

acceptable for the TGAI and formulated product of flutriafol. Supplemental non-guideline 
56

honeybee acute oral tests with flutriafol and its product were also submitted and are included in the 

honeybee study. The description and classification of the available honeybee acute contact and oral

studies are discussed below and summarized in Table III-21 and Appendix F.

Table III-21. Acute Contact and Oral Toxicity of Flutriafol TGAI and Flutriafol 125 g/L SC to 

Honeybees

Species % ai LD50/LC50

(μg ai/bee)

Toxicity 

Category*

MRID No. Study 

Classification

Flutriafol TGAI

Honey bee 93

>50 Practically nontoxic

47090326

McIntosh and 

Wilkinson. 1982.

Acceptable

>2 Not categorized Supplemental †

Flutriafol 125 g/L SC

Honey bee

(contact)

12.7

>52.5 Practically nontoxic

47090326

McIntosh and 

Wilkinson (1982)

Acceptable

>10.5 Practically nontoxic Acceptable

Honey bee

(oral)

47 N/A Supplemental†

>50 N/A Supplemental†

Honey bee

(contact)

12.1

1280 μg/bee or 1% 

of sucrose Practically nontoxic

47090327

Kleiner, R (1994)

Acceptable

Honey bee

(oral)

>24 N/A Supplemental1

† Acute oral - a non-guideline study 

* The LD50s were greater than the highest concentration; therefore, it was not possible to calculate a probit 

slope and 95% confidence intervals. 

(2) Chronic Effects 

Birds, Reproduction

Avian reproduction studies using the TGAI are required to establish the chronic toxicity of 

flutriafol to birds, especially preceding or during the breeding season (Table III-22). The 

preferred test species are mallard duck and bobwhite quail. The data that were submitted show the 

reproduction NOAEC for duck and quail to be 39.2 and <95.0 mg ai/kg diet, respectively. Results 

indicate mallard duck is more sensitive to the TGAI than bobwhite quail; therefore, the duck 

NOAEC value of 39.2 mg ai/kg-diet is used to evaluate potential chronic effects of the TGAI to 

birds. The guideline (OPPTS 850.2300) is fulfilled. The duck study (MRID 47090322) is 

classified as acceptable while the quail study (MRID 47090323) is considered supplemental in the 

absence of an NOAEC as a result of significant effects at all test levels. The description and 

classification of the available avian reproduction studies are discussed below and summarized in 
57

Table III-22 and Appendix F. No avian reproduction toxicity data with the formulated product of 

flutriafol are available.

Table III-22. Chronic Toxicity of Flutriafol TGAI to Bobwhite Quail and Mallard Ducks.

Species % 

a.i.

NOAEC 

(mg ai/kgdiet)

LOAEC 

(mg ai/kgdiet)

Affected 

endpoints

MRID no.

Author/Year

Study 

classification

Northern 

bobwhite quail

(Colinus 

virginianus)

94.4 <95.0 95.0 Reproduction

47090323

Thompson. 

2007.

Supplemental 1

Mallard duck

(Anas 

platyrhynchos)

95.1 39.2 97.5 Reproduction

47090322

Temple. 2006. Acceptable

1 The ratio of hatchling survival to number of eggs set and 14-day old survivor weight was adversely affected at all treatment 

levels; therefore, a chronic toxicity threshold could not be determined. 

Mammals, Reproduction

In a 2-generation reproduction study (Table III-23) with rats exposed to the TGAI, there were no 

reproductive effects observed for both sexes at concentrations of 0, 60, 240, and 1000 ppm 

(calculated to be 0, 4.8, 20.6 and 88.7 mg/kg bw/day in parental (P) males; and 0, 5.5, 21.9 and 

103 mg/kg bw day in P females). The reproductive LOAEL (Male/Female) is determined to be 

>1000 ppm (>88.7/>103 mg ai/kg bw/day), while the parental and offspring LOAEL and NOAEL 

are both 1000 ppm (88.7/103 mg ai/kg bw/day) and 240 ppm (20.6/21.9 mg ai/kg bw/day), 

respectively. The lowest NOAEL of 240 ppm and 20.6 mg ai/kg bw/day from this study are used 

in the risk assessment. The available mammalian reproduction study is summarized in Table III23 and discussed in Appendix F. No mammalian reproduction toxicity data with the formulated

product of flutriafol are available.

Table III-23. Mammalian Reproductive Toxicity for Flutriafol TGAI.

Species

% ai Test

Type

Toxicity

ppm (mg/kg bw/day)

Affected 

Endpoints

MRID No.

Study author 

Classification

Rat

(Sprague 

Dawley)

93 2-generation

Parental

NOAEL = 240 (20.6 in P males; 

21.9 in P females)

LOAEL = 1000 (88.7 in P 

males; 103 in P females)

decreased body 

weight gains, food 

consumption, 

effects on liver

Reproductive 47090351

NOAEL = 1000 (88.7 – 103)

LOAEL >1000 None

Offspring

NOAEL = 240 (20.6 in P males; 

21.9 in P females)

LOAEL = 1000 (88.7 in P 

males; 103 in P females)

decreased live 

birth index and 

litter size, effects 

on liver 
58

(3) Sub-lethal Effects 

In the acute studies with birds and mammals, sublethal effects observed included subdued 

behavior, weakness, squatting, prostration, unsteadiness, body weight, food consumption, clinical 

signs of toxicity, pale/blotchy livers, and lying on floor at levels higher than for mortality. In 

addition to acute studies, the sublethal effects observed in the chronic studies with birds were eggs 

laid per female, eggs set per female, shell thickness, viable embryos, % viable embryos of eggs set, 

live 3-week embryos, % live 3-week embryos of viable embryos, % normal hatchlings, % normal 

hatchlings of eggs laid, % normal hatchlings of eggs set, % normal hatchlings of live 3-week 

embryos, % hatchling survival % 14-day survivors, % 14-day survivors of eggs set, maternal body

weight, and survivor body weight. The sublethal effects observed in the rat reproduction study

were body weight gains, food consumption, effects on liver, live birth index, and litter size. The 

observed sub-lethal effects in these chronic studies with birds and mammals occurred at levels 

higher than or equal to the NOAEC.

(4) Field Studies 

Data were not available to evaluate population recovery, age-class strengths, or shifts in species 

composition of terrestrial animals when exposed to flutriafol.

b. Terrestrial Plants 

Terrestrial plant studies are required for all terrestrial outdoor pesticides. Terrestrial plant toxicity

studies were conducted to establish the toxicity of flutriafol formulated product at the maximum 

dose to non-target terrestrial plants. The recommendations for seedling emergence and vegetative 

vigor studies are for testing of (1) six species of at least four dicotyledonous families, one species 

of which is soybean (Glycine max), and the second of which is a root crop, and (2) four species of 

at least two monocotyledonous families, one of which is corn (Zea mays). Results with monocots 

and dicots indicate that seedling emergence and vegetative vigor were not inhibited by 25% or 

more via exposure to the flutriafol formulation at 0.12 lb ai/A. Even though 25% inhibition was 

not evident in the studies, a statistically significant reduction of dry weight (ryegrass) in the 

vegetative vigor study was observed; resulting in the need for a tier II study with ryegrass. After 

reviewing all studies, the seedling emergence NOAEC is >0.12 lb ai/A (MRID 47090328); and the 

vegetative vigor NOAEC is ≥0.12 lb ai/A (MRIDs 47090329 and 47689801). The three studies are 

acceptable and fulfill the guidelines (OPPTS 850.4100 and 850.4150). The description and 

classification of the available terrestrial plants studies are discussed below and summarized in 

Tables III-24, III-25, and III-26.

Seedling Emergence

Table III-24. Summary of Tier I Seedling Emergence Results for Flutriafol 125 g/L SC *

Species Most sensitive

endpoint

% 

Inhibition

t-Test1

(p-value)

Significant 

Effect?

(yes or no)

MRID

Author/Year

Study 

Classification

Corn Length 4.8 n/a No 47090328

Porch, 

Acceptable

Onion Dry weight 6.9 0.63 No
59

Ryegrass Emergence 8.8 0.23 No Martin, and 

Krueger. 

2006.

Wheat Length 1.6 n/a No

Cabbage Dry weight 6.1 0.42 No

Lettuce Dry weight 6.8 0.44 No

Radish Length 2.8 n/a No

Soybean Dry weight 9.0 0.32 No

Sugar beet Emergence 3.2 n/a No

Tomato None 0.0 n/a No 

* 11.9% flutriafol, tested at the maximum application rate of 0.12 lb ai/A

1 A t-test is required when any endpoint exhibits >5% inhibition at the maximum dose when compared to negative control. 

For any endpoint with less than 5% inhibition, a t-test is not required. 

2 A p-value of 0.05 or smaller indicates a significant effect at the maximum dose.

Vegetative Vigor

Table III-25. Summary of Tier I Vegetative Vigor Results for Flutriafol 125 g/L SC *

Species Most sensitive 

endpoint

% 

Inhibition

t-Test1

(p-value)

Significant 

Effect?

(yes or no)

MRID

Author/Year

Study 

Classification

Corn Length 0.9 n/a No 47090329

Porch, 

Martin, and 

Krueger. 

2006.

Acceptable

Onion None -4.2 n/a No

Ryegrass Dry weight 17.1 0.009 Yes

Wheat Length 0.9 n/a No

Cabbage None -6.5 n/a No

Lettuce None -4.5 n/a No

Radish Dry weight 6.7 0.22 No 

Soybean Dry weight 1.8 n/a No

Sugar beet Dry weight 15.1 0.32 No 

Tomato None -6.0 n/a No

* 11.9% flutriafol, tested at the maximum application rate of 0.12 lb ai/A

1 A t-test is required when any endpoint exhibits >5% inhibition at the maximum dose when compared to negative control. 

For any endpoint with less than 5% inhibition, a t-test is not required. 

2 A p-value of 0.05 or smaller indicates a significant effect at the maximum dose.

Table III-26. Summary of Tier II Vegetative Vigor Results for Flutriafol 125 g/L SC with Ryegrass*

Species EC50

(lb ai/A)

EC25

(lb ai/A)

NOAEC 

(lb ai/A)

Affected 

endpoints

MRID no.

Author/Year

Study 

classification

Ryegrass >0.26 >0.26 0.26 None

47689801

Porch, Martin, and 

Krueger. 2009.

Acceptable

* 11.9% flutriafol, tested at the maximum application rate of 0.26 lb ai/A

IV. RISK CHARACTERIZATION

Risk characterization provides the final step in the risk assessment process. In this step, exposure 

and effects characterization are integrated to provide an estimate of risk relative to OPP’s 

established levels of concern (LOCs). The results are then interpreted for the risk manager through 

a risk description and synthesized into an overall conclusion.
60

A. Risk Estimation - Integration of Exposure and Effects Data 

A deterministic approach is used to evaluate the likelihood of adverse ecological effects to nontarget species. In this approach, risk quotients (RQs) are calculated by dividing exposure estimates 

(EECs) by ecotoxicity values for non-target species, both acute and chronic. 

RQ = EXPOSURE/TOXICITY

RQs are then compared to OPP's levels of concern (LOCs). These LOCs are criteria used by OPP 

to indicate potential risk to non-target wildlife and the need to consider regulatory action. 

Exceedance of the LOC by the RQ indicates that a pesticide used as directed has the potential to 

cause adverse effects on non-target wildlife. LOCs currently address the following risk 

presumption categories: (1) acute risk - potential for acute risk to non-target animals which may

warrant regulatory action in addition to restricted use classification, (2) acute restricted use –

potential for acute risk to non-target animals, but may be mitigated through restricted use 

classification, (3) acute endangered species – endangered species may be potentially affected by

use, (4) chronic risk – potential for chronic risk may warrant regulatory action, endangered 

species may potentially be affected through chronic exposure, (5) non-listed plant risk - potential 

for effects in non-target (non-listed) plants, and (6) listed plant risk – potential for effects in listed

plants. Currently, EFED does not perform baseline assessments for chronic risk to plants or acute 

or chronic risks to non-target insects.

For acute studies on taxa where no effects were observed at any concentration level, the RQ is not 

calculated. For acute studies on taxa where an LC/LD50 is not established due to insufficient 

mortality but reported some mortality in the study, an RQ is not calculated, and the study is 

discussed further in the Risk Description section.

Risk presumptions, along with the corresponding RQs and LOCs are tabulated below in Tables 

IV-1, -2, and -3:
61

Table IV-1. Risk Presumptions for Terrestrial Animals 

Risk Presumption RQ LOC

Birds:

Acute Risk EEC1

/LC50 or LD50/sqft2or LD50/day3 ≥0.5

Acute Restricted Use EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg ai/kg) ≥0.2

Endangered Species EEC/LC50 or LD50/sqft or LD50/day ≥0.1

Chronic Risk EEC/NOAEC ≥1

Wild Mammals:

Acute Risk EEC/LC50 or LD50/sqft or LD50/day ≥0.5

Acute Restricted Use

EEC/LC50 or LD50/sqft or LD50/day

(or LD50 < 50 mg ai/kg)

≥0.2

Endangered Species EEC/LC50 or LD50/sqft or LD50/day ≥0.1

Chronic Risk EEC/NOAEC ≥1

Invertebrates:

Endangered Species EEC/LD50 ≥0.05

1 EEC=abbreviation for Estimated Environmental Concentration (mg ai/kg) on avian/mammalian food items 

2

 mg/ft 3 mg of toxicant consumed/day

 LD50 * wt. of bird LD50 * wt. of bird 

Table IV-2. Risk Presumptions for Aquatic Animals

Risk Presumption RQ LOC

Acute Risk EEC1/LC50 or EC50 ≥0.5

Acute Restricted Use EEC/LC50 or EC50 ≥0.1

Acute Endangered Species EEC/LC50 or EC50 ≥0.05

Chronic Risk EEC/NOAEC ≥1

1 EEC = (mg ai/L or μg ai/L) in water

Table IV-3. Risk Presumptions for Plants 

Risk Presumption RQ LOC

Terrestrial Plants in Terrestrial and Semi-Aquatic Areas:

Non-Listed Species EEC1/EC25 ≥1

Listed Species EEC/NOAEC or EC05

3

≥1

Aquatic Plants:

Non-Listed Species EEC2

/EC50 ≥1

Listed Species EEC/NOAEC or EC05

3

≥1

1

 EEC = lbs ai/acre 2 EEC = (μg ai/L or mg ai/L) in water 

3 An EC05 is only used when a definitive NOAEC is not available.
62

The following section presents the acute and chronic risk quotients calculated for flutriafol and its 

formulated product and the LOCs (if any) that are exceeded. Further discussion of the risk 

quotients and uncertainties in the assessment is presented in Section IV and Appendices C, D, 

and E.

1. Non-target Aquatic Animals and Plants

For this baseline risk assessment with aquatic animals and plants, acute and chronic RQs are 

derived based on ecological toxicity data for both the AI alone and its formulated product, 

Flutriafol 125 g/L SC, and then compared to the EECs generated from GENEEC2, 

PRZM/EXAMs, and AgDRIFT. For this assessment, acute and chronic risks to aquatic animals 

exposed to the AI alone are calculated by comparing the acute and chronic toxicity values of the 

AI alone to GENEEC EECs, while the risks for aquatic animals exposed to the formulated product 

are calculated by dividing the acute toxicity value of the product itself (mg form/L) by AgDRIFT 

EECs. The risks for aquatic plants adjacent to soybean sites exposed to flutriafol are calculated by 

comparing the toxicity values of the AI in its formulated product to GENEEC EECs, while the 

risks for aquatic plants adjacent to apple sites are compared with PRZM/EXAMs EECs.

Table IV-4 presents the toxicity endpoint values used to calculate acute and chronic risk quotients 

(RQs) and estimate risk to aquatic receptors from exposure through spray drift and surface 

runoff/leaching with GENEEC2 EECs (Table III-5) or PRZM/EXAMS EECs (Table III-7). 

Details of the acute and chronic EEC calculations for aquatic animals and plants are provided in 

Section III.2. The potential risks to aquatic animals and plants are described further in the Risk 

Description section.
63

Table IV-4. Flutriafol TGAI Toxicity Endpoint Values for Assessing Risk to Aquatic Animals and Plants

Exposure 

Scenario

Species Exposure 

Duration

Toxicity Endpoint 

Value

Endpoint Reference 

(Classification)

Freshwater Fish

Acute Bluegill sunfish

Lepomis macrochirus 96 hour LC50 = 33 mg ai/L Survival MRID 47090310(Acceptable)

Chronic Fathead minnow

Pimephales promelas

Early Life 

Stage NOAEC = 4.8 mg ai/L Survival and Growth

MRID 47090317

(Acceptable)

Freshwater Invertebrates

Acute Water flea

Daphnia magna

48 hour EC50 = 67.1 mg ai/L Immobility MRID 47090304

(Acceptable)

Chronic Life-cycle NOAEC = 0.31 mg ai/L Growth MRID 47090314

(Acceptable)

Estuarine/Marine Fish

Acute Sheepshead minnow

Cyprinodon variegatus

96 hour LC50 >72.2 mg ai/L Survival MRID 47090308

(Acceptable)

Chronic NOAEC = >11 mg ai/L1 Acute to Chronic 

Ratio

Estuarine/Marine Invertebrates

Acute

Eastern oyster

Crassostrea virginia

(shell deposition)

96 hour EC50 = 25 mg ai/L Growth MRID 47090306

(Acceptable)

Chronic NOAEC = 0.16 mg ai/L2 Acute to Chronic 

Ratio

1 Estimated using an acute to chronic ratio (ACR) as follows: Sheepshead minnow LC50 x minnow NOAEC  sunfish LC50 = 

estimated estuarine/marine fish NOAEC 

2 Estimated using an acute to chronic ratio (ACR) as follows: Mysid EC50 x daphnid NOAEC  daphnid EC50 = estimated 

estuarine/marine invertebrate NOAEC

In addition to aquatic toxicity studies for the active ingredient, Table IV-5 presents the toxicity

endpoint values of the registrant-submitted studies on Flutriafol 125 g/L SC, the formulated

product containing 11.9% active ingredient flutriafol. The formulated product tested is the same 

product proposed for registration as a formulated product of the new chemical. These toxicity

endpoint values are used to further assess the risks to fish and invertebrates from the formulated 

product because of concerns that the toxicity of the formulated product is significantly more toxic 

than the active ingredient alone. Therefore, the risks to the formulated product must be assessed 

rather than to just the active ingredient alone. Based on available formulation data, it appears that 

the enhanced toxicity of the formulation is due to the presence of the inert ingredient(s) within the

formulation, rather than the AI.
64

Table IV-5. Flutriafol 125 g/L SC Toxicity Endpoint Values for Assessing Risk to Aquatic Animals

Exposure 

Scenario

Species Exposure 

Duration

Toxicity Endpoint Value Endpoint Reference 

(Classification)

Freshwater Fish

Acute Bluegill sunfish

Lepomis macrochirus 96 hour LC50 = 7.9 mg form/L Survival MRID 47090312(Acceptable)

Estuarine/marine Fish

Acute LC50 = >17 mg form/L1 AAR

Freshwater Invertebrates

Acute Water flea

Daphnia magna 48 hour EC50 = 0.83 mg ai/L(7.05 mg form/L) Immobility MRID 47090305(Acceptable)

Estuarine/marine Invertebrates

Acute EC50 = 2.5 mg form/L 2 AAR

Aquatic Plants

Nonvascular Marine diatom

Skeletonema costatum 96-hour

EC50 = 0.46 mg ai/L;

(3.9 mg form/L)

NOAEC = 0.1 mg ai/L;

(0.84 mg form/L)

Growth MRID 47090331

(Supplemental4)

Vascular Duckweed 

Lemna gibba 7day

EC50 = 0.78 mg ai/L;

(6.6 mg form/L)

EC05 = 0.018 mg ai/L3;

(0.15 mg form/L)

Growth MRID 47090330

(Supplemental4)

1 Estimated using an acute to acute ratio (AAR) as follows: Sheepshead minnow LC50 of AI value in product x sunfish LC50 of AI 

value in product  sunfish LC50 of the TGAI = estimated estuarine/marine fish LC50 of the AI in its formulated product x 11.9% = 

estimated estuarine/marine fish LC50 of the product.

2 Estimated using an acute to acute ratio (AAR) as follows: Oyster EC50 of AI value in product x daphnid EC50 of AI value in 

product  daphnid LC50 of the TGAI = estimated estuarine/marine invertebrate LC50 of the AI in its formulated product x 11.9% AI 

= estimated estuarine/marine invertebrate LC50 of the product.

3 With inhibition observed at all treatment levels, the NOAEC is determined to be below the lowest treatment level. The surrogate 

EC05 is used in the absence of a NOAEC to calculate the risks to endangered aquatic nonvascular plants.

4 Data were not available to establish a dose-response curve for the formulation inerts.

AAR – acute to acute ratio

a. Fish

Acute Risk Quotients of the AI alone

For the apple use scenario with the TGAI, the acute RQ of <0.01 does not exceed the acute 

endangered LOC of 0.05 for freshwater fish, therefore, there are no acute LOC exceedances for the 

soybean use scenarios because the EECs/RQs are lower than the apple scenario. A definitive acute 

toxicity threshold was not established for estuarine/marine fish (acute LC50 >72.2 mg ai/L), RQs 

are not quantitatively estimated. The results for freshwater fish are provided in Table IV-6.
65

Table IV-6. Flutriafol Acute Risk Quotients for Freshwater Fish Based On a Bluegill Sunfish LC50 of 33 mg 

ai/L and for Estuarine/marine Fish Based on a Sheepshead Minnow LC50 of >72.2 mg ai/L.

Site / Application 

Method / Rate in lbs 

ai/A (No. of Apps.)

Sunfish

LC50

(mg ai/L)

Minnow 

LC50 

(mg ai/L)

Peak

GENEEC

EEC

(mg ai/L)

Freshwater Fish

Acute RQ 

(EEC/ Sunfish 

LC50)

Estuarine/marine

Fish 

Acute RQ

(EEC/ Minnow LC50) 

Apples / ground

0.11 (4) 

33 >72.2 0.021 <0.01 RQ not estimated

Acute Risk Quotients of the Formulated Product itself

Using AgDRIFT EECs from the soybean aerial scenarios with the toxicity value for the formulated

product itself, the acute RQ of <0.01 does not exceed the acute endangered species LOC of 0.05 

for freshwater fish. Thus, no acute LOC exceedances for the apple ground and soybean ground 

scenarios because the RQs are lower than the soybean aerial scenarios.

There is a potential for acute exposure to estuarine/marine fish from the product, but acute risks 

are not quantitatively estimated because toxicity information on the formulated product, Flutriafol 

125 g/L SC, was not established (estimated acute LC50 >17 mg form/L) and will be discussed 

qualitatively in the Risk Description section. The results for freshwater fish are provided in Table 

IV-7.

Table IV-7. Flutriafol 125 g/L SC Formulated Product Acute Risk Quotients for Freshwater Fish Based On a Sunfish 

LC50 of 0.92 mg ai/L and 7.9 mg form/L

Site / Application 

Method

Sunfish 

LC50

(mg ai/L)

Sunfish 

LC50

(mg form/L)

Peak 

GENEEC 

EEC 

(mg ai/L)

AgDRIFT

EEC1

(mg form/L)

Acute RQ 

(EEC/ TGAI)

Acute RQ

(EEC/ FORM)

soybean / aerial N/A 7.9 N/A 0.0036 N/A <0.01

apple / ground 0.92 N/A 0.021 N/A 0.035 N/A

1 Based on acute EECs (Table III-4) from spray drift alone, excluding runoff assumptions.

Chronic Risk Quotients of the AI alone

For the proposed uses of the AI alone, the chronic risk LOC is not exceeded for freshwater fish

from multiple applications. Using the highest estimated GENEEC EEC for the ground spray to 

apple scenario/lowest NOAEC combination (60-day EEC value of 0.021 mg ai/L) and the 

corresponding chronic NOAEC (4.8 mg ai/L for freshwater fish), the highest chronic RQ is <0.01,

which is below the chronic risk LOC of 1. Chronic RQs for freshwater fish based on the other use 

scenarios including ground and aerial application to soybeans are also less than the LOC. 

Therefore, an RQ summary table for chronic exposure of flutriafol TGAI to freshwater fish is not 

provided. 

No chronic toxicity data for the AI alone with estuarine/marine fish is available, a fish acute to 

chronic ratio was used to estimate the estuarine/marine fish chronic value (NOAEC) of >11 mg 

ai/L. The estimated NOAEC value of >11 mg ai/L is not a definitive chronic toxicity threshold for 
66

estuarine/marine fish exposed to the AI alone; thus, chronic RQs for estuarine/marine fish are not 

quantitatively estimated.

b. Invertebrates

Acute Risk Quotients of the AI alone

Based on the most conservative exposure scenario (apple) for the AI alone, the acute RQs of <0.1

do not exceed the acute listed species LOC of 0.05 for freshwater and estuarine/marine 

invertebrates. All other acute RQs for both freshwater and estuarine/marine invertebrates are less 

than 0.01 for all other scenarios. The results for freshwater and estuarine/marine invertebrates

exposed to the AI alone are provided in Table IV-8. 

Table IV-8. Flutriafol Acute Risk Quotients for Invertebrates Based On a Daphnid EC50 of 67 mg ai/L

and for Estuarine/marine Invertebrates Based on an Eastern oyster EC50 of 25 mg ai/L.

Site/ Application 

Method/ Rate in 

lbs ai/A (No. of 

Apps.)

Daphnid

EC50

(mg ai/L)

Oyster 

EC50 

(mg ai/L)

Peak 

GENEEC

EEC

(mg ai/L)

FW Invertebrates

Acute RQ 

(EEC/ Daphnid 

EC50)

E/M Invertebrates

Acute RQ

(EEC/ Oyster EC50) 

Apples / ground

0.11 (4) 

67 25 0.021 <0.01 <0.01

Acute Risk Quotients of the Formulated Product itself

Based on the most conservative exposure scenario (soybean aerial) for Flutriafol 125 g/L SC, the 

acute RQs of <0.01 do not exceed the acute endangered species LOC of 0.05 for freshwater and 

estuarine/marine invertebrates exposed to the formulated product itself. All other spray drift RQs 

for both freshwater and estuarine/marine invertebrates are less than 0.01 for all other scenarios. 

The results are provided in Table IV-9.

Table IV-9. Flutriafol 125 g/L SC Formulated Product Acute Risk Quotients for Invertebrates Based On a 

Daphnid EC50 of 7.05 mg form/L and Estuarine/marine Invertebrate LC50 of 2.5 mg form/L

Site/ Application Method

Daphnid 

EC50

(mg form/L)

E/M 

Invertebrate

EC50

(mg form/L)

AgDRIFT

EEC1

(mg form/L)

FW Inv.

Acute RQ

(EEC/

FORM) 

E/M Inv.

Acute RQ

(EEC/ FORM) 

Soybean / aerial 

7.05 2.5 0.0036 <0.01 <0.01

1 Based on acute EECs from spray drift alone, excluding runoff assumptions.

Chronic Risk Quotients of the AI alone

Based on available toxicity data of the AI alone and flutriafol application in apple and soybean

sites, the chronic risk LOC is not exceeded for freshwater invertebrates. Using the estimated EEC 

for the standard pond scenario/NOAEC combination (21-day EEC value of 0.021 mg ai/L for 

ground application to apples) and the corresponding chronic NOAEC (0.31 mg ai/L for freshwater 

invertebrates), the chronic RQ is 0.068, which is well below the chronic risk LOC of 1. RQs for 

the other scenarios are not expected to exceed the chronic LOC because EECs from these exposure 
67

scenarios are lower than the most conservative scenario. Therefore, an RQ summary table is not 

provided. 

No chronic toxicity data for the AI alone with estuarine/marine invertebrates was available to 

estimate a chronic NOAEC value, an invertebrate acute to chronic ratio analysis was used to 

determine the estuarine/marine invertebrate chronic value (NOAEC) of 0.16 mg ai/L. 

1) Daphnid acute value = 67.1 mg ai/L = 216 (ACR)

 Daphnid chronic value 0.31 mg ai/L

2) Mysid acute value = 34.9 mg ai/L (actual) = 0.16 mg ai/L (estimated chronic value)

 ACR 216 

3) 21-day EEC/Mysid chronic value = 0.032 (actual) = 0.2 (RQ)

 0.16 mg ai/L (estimated chronic value)

Assuming an estimated NOAEC value of 0.16 mg ai/L for estuarine/marine invertebrates exposed 

to the AI alone, the chronic RQ of 0.2 does not exceed the chronic risk and endangered species 

LOC of 1. Therefore, it is unlikely that the chronic LOC would be exceeded for estuarine/marine 

invertebrates when exposed to the AI only.

c. Aquatic Plants

There is a potential for exposure of the active ingredient to aquatic vascular and nonvascular plant 

species. Toxicity data with the typical end-use product are used to estimate the risks of the AI in 

its product to aquatic plants as a result of runoff and drift, while the risks to the formulation itself

for aquatic plants are based on spray drift only. 

(1) Non-listed Plants

Non-listed Plant Risk Quotients of AI in its Formulated Product

The toxicity value of the AI in its formulated product with peak GENEEC EEC of all scenarios 

does not exceed the non-listed plant LOC of 1.0 for aquatic vascular and non-vascular plants. 

Results are provided in Table IV-10.

Table IV-10. Flutriafol 125 g/L SC Formulated Product Risk Quotients for Non-listed Aquatic Plants 

Based On a Duckweed EC50 of 0.78 mg ai/L and a Diatom EC50 of 0.46 mg ai/L1

Scenario

Peak 

GENEEC

EEC

(mg ai/L)

Toxicity Non-Listed Plant RQs

Vascular Non-Vascular Vascular Non-Vascular

Ground Spray to Apples 

(0.11 lb ai/A x 4 apps x 7D 

intervals)

0.021 0.78 0.46 0.03 0.05

1Detailed calculations for GENEEC EECs are provided in Section III.2
68

Non-listed Plant Risk Quotients of the Flutriafol Formulated Product itself

For the total toxicity of the formulated product with AgDRIFT EECs, there are no exceedances of 

the non-listed LOC for both vascular and non-vascular plants exposed to spray drift via ground 

spray to apples and from ground/aerial spray to soybeans. Results are provided in Table IV-12.

Table IV-11. Flutriafol 125 g/L SC Formulated Product Risk Quotients for Non-listed Aquatic Plants 

Based On a Duckweed EC50 of 6.6 mg form/L and a Diatom EC50 of 3.9 mg form/L1

Scenario

AgDRIFT

EEC

(mg form/L)

Toxicity (mg form/L) Non-Listed Plant RQs

Vascular Non-Vascular Vascular Non-Vascular

Aerial Spray to Soybeans

(0.5 lb form/A x 3 apps x 

7D intervals)

0.0036 0.78 0.46 <0.1 0.03

1Detailed calculations for acute EECs are provided in Section III.4.

(2) Listed Plants

Listed Plant Risk Quotients of the AI in its Formulated Product

a. Risk Quotients for Listed Aquatic Plants Adjacent 

Soybean Sites

The toxicity value of the AI in its formulated product with peak GENEEC EEC do not exceed the 

listed plant LOC of 1.0 for aquatic vascular and nonvascular plants adjacent to treated soybean 

sites. Results are provided in Table IV-12.

Table IV-12. Flutriafol 125 g/L SC Formulated Product Risk Quotients for Listed Aquatic Plants Based 

On a Surrogate Duckweed EC05 of 0.018 mg ai/L and a Diatom NOAEC of 0.1 mg ai/L1

Scenario

Peak 

GENEEC

EEC

(mg ai/L)

Toxicity Listed Plant RQs

Vascular Non-Vascular Vascular Non-Vascular

Ground Spray to Soybeans

(0.6 lb ai/A x 3 apps x 14D 

intervals)

0.0086 0.018 0.1 0.5 <0.1

Aerial Spray to Soybeans

(0.6 lb ai/A x 3 apps x 14D 

intervals)

0.01 0.018 0.1 0.6 <0.1

Ground Spray to Soybeans

(0.6 lb ai/A x 3 apps x 21D 

intervals)

0.0087 0.018 0.1 0.5 <0.1

Aerial Spray to Soybeans

(0.6 lb ai/A x 3 apps x 21D 

intervals)

0.009 0.018 0.1 0.5 <0.1

* Bold value indicate LOC exceedance (*exceeds the listed plant LOC of 1)

A EC05 is used in absence of NOAEC

1Detailed calculations for GENEEC EECs are provided in Section III.2.

b. Risk Quotients for Listed Aquatic Plants Adjacent Apple 

Sites
69

When the toxicity values of the AI in its product are compared with tier II PRZM/EXAMs EECs

for apple use in different geographical locations, the refined RQs do not exceed the listed plant 

LOC of 1.0 for both aquatic vascular and nonvascular plants adjacent to treated apple fields. Thus, 

there are no LOC exceedances for aquatic plants adjacent apple and soybean fields. Results are 

provided in Table IV-12a.

Table IV-12a. Flutriafol 125 g/L SC Formulated Product Risk Quotients for Listed Aquatic Plants Based 

On a Surrogate Duckweed EC05 of 0.018 mg ai/L and a Diatom NOAEC of 0.1 mg ai/L1,2

Scenario

Peak 

PRZM/EXAMs 

EEC (mg ai/L)

Toxicity Listed Plant RQs

Vascular Non-Vascular Vascular Non-Vascular

NC Apples 0.01 0.018A0.1 0.6 0.1

OR Apples 0.003 0.018 0.1 0.2 <0.1

PA Apples 0.006 0.018 0.1 0.3 <0.1

* Bold values indicate LOC exceedance (*exceeds the listed plant LOC of 1)

A EC05 is used in absence of NOAEC

1Detailed calculations for GENEEC EECs are provided in Section III.2.

2 Ground Spray to Apples (0.11 lb ai/A x 4 apps x 7D intervals)

Listed Plant Risk Quotients of the Flutriafol Formulated Product itself

Based on available toxicity data for Flutriafol 125 g/L SC itself and AgDRIFT EECs, there are no

exceedances of the listed plant LOC for vascular and nonvascular aquatic plants receiving 

exposure via spray drift alone from adjacent treated soybean sites (Table IV-13). All other RQs 

for listed plants are less than 1.0 for all other scenarios.

Table IV-13. Flutriafol 125 g/L SC Formulated Product Risk Quotients for Listed Aquatic Plants Based 

On a Surrogate Duckweed EC05 of 0.15 mg form/L and a Diatom NOAEC of 0.84 mg form/L1,2

Scenario

AgDRIFT

EEC

(mg form/L)

Toxicity Listed Plant RQs

Vascular Non-Vascular Vascular Non-Vascular

Aerial Spray to Soybeans

(0.5 lb form/A x 3 apps x 7D 

intervals)

0.0036 0.15A0.84 <0.1 <0.1

A EC05 is used in absence of NOAEC

1Detailed calculations for acute EECs are provided in Section III.4.

d. Aquatic-phase Amphibians and Reptiles

EFED currently uses surrogate data (freshwater fish) for aquatic-phase amphibians. Risks are 

qualitatively discussed in the Risk Description section.

2. Non-target Terrestrial Animals 

For this baseline risk assessment with terrestrial animals, acute and chronic RQs are derived based 

on ecological toxicity data for both the AI alone and its formulated product, Flutriafol 125 g/L SC, 

and then compared to the EECs generated from T-REX and AgDRIFT. Acute and chronic RQs for 
70

terrestrial animals exposed to the AI alone are calculated by comparing the acute and chronic 

toxicity values of the AI alone to T-REX EECs. Acute RQs for the product itself are calculated by 

dividing the acute toxicity value of the flutriafol formulated product itself to AgDRIFT EECs.

Tables IV-14 and IV-15 present the AI alone and its formulated product toxicity endpoint values, 

respectively, used to calculate RQs and estimate risk to terrestrial receptors from flutriafol residues 

as a result of direct deposition and spray drift from broadcast applications. Details of the RQ 

calculations for terrestrial animals are provided below and in Appendix D. The potential risks to 

terrestrial animals are described further in the Risk Description section.

Table IV-14. Flutriafol Toxicity Endpoint Values for Assessing Risk to Terrestrial Animals

Exposure 

Scenario

Species Exposure 

Duration

Toxicity Endpoint 

Value

Endpoint Reference 

(Classification)

Mammal

Acute Oral Laboratory 

mouse (20 g)

Single Oral 

Dose

LD50 Females = 179 mg

ai/kg bw Survival MRID 47090335(Acceptable)

Chronic

Reproduction Laboratory rat 2-generation

NOAEC = 240 mg ai/kgdiet (20.6 mg ai/kg 

bw/day in P1 males).

Parental and 

offspring toxicity

MRID 47090351

(Acceptable)

Birds

Acute Oral

Red-legged 

Partridge (430g) 

Alectoris rufa

Single Oral 

Dose LD50 = 616 mg ai/kg bw None MRID 47090319

(Acceptable)

Subacute 

Dietary

Mallard duck 

Anas 

platyrhynchos

8 days LC50 = 4062 mg ai/kgdiet None MRID 47090320

(Acceptable)

Chronic

Mallard duck 

Anas 

platyrhynchos

one 

generation

NOAEC = 39.2 mg 

ai/kg-diet

Reproduction

(percentage of 

hatchlings of live 3-

week embryos, 

percentage of 

hatchling of eggs 

set, 14-day 

survivors, and 

number of 

hatchling)

MRID 47090322

(Acceptable)

Insects

Acute Contact Honey Bee

Apis mellifera 96 hour LD50 >50 μg ai/bee None MRID 47090326

(Acceptable)
71

Table IV-15. Flutriafol 125 g/L SC Toxicity Endpoint Values for Assessing Risk to Terrestrial Animals

Exposure 

Scenario

Species Exposure 

Duration

Toxicity Endpoint 

Value

Endpoint Reference 

(Classification)

Mammal

Acute Oral Laboratory rat Single Oral 

Dose

LD50 = >2000 mg

form/kg bw Survival MRID 47090003(Acceptable)

Insects

Acute Contact Honey Bee

Apis mellifera 96 hour LD50 >10.5 μg ai/bee None MRID 47090326

(Acceptable)

Two types of risk quotients are calculated to evaluate the risks to birds and mammals based on the 

estimated dietary residue concentrations determined from the Kenaga nomogram: (1) dietary

based RQs; and (2) dose based RQs. These RQs are not equivalent. Dietary risk quotients are 

calculated by directly comparing the concentration of a pesticide administered (or estimated to be 

administered) to experimental animals in the diet in a toxicity study to the concentration estimated 

to be on selected food items. These risk quotients do not account for the fact that smaller-sized 

animals need to consume more food relative to their body weight than larger animals or those 

differential amounts of food are consumed depending on the water content and nutritive value of 

the food. The dose-based risk quotients do account for these factors. The dose-based RQs 

incorporate the ingestion rate-adjusted exposure from the various food items to the different 

weight classes of birds and mammals and the weight class-scaled toxicity endpoints. Details can be 

found in Appendix D. Formulas presented below are used to calculate dose-based and dietary

based risk quotients: 

Table IV-16. Formulas Used to Calculate Dose-Based and Dietary-Based Risk Quotients

Duration Dose or 

Dietary RQ

Surrogate 

Organism

Equation

Acute Dose-based Birds and 

mammals

Acute Daily Exposure (mg/kg-bw) / adjusted LD50 (mg/kgbw)

Dietary-based Birds Kenaga EEC (mg/kg-food item) / LC50 (mg/kg-diet)

Chronic Dietary-based Birds and 

mammals

EEC (mg/kg-food item) / NOAEC (mg/kg-diet)

Dose-based Mammals only EEC (mg/kg-bw) / Adjusted NOAEL (mg/kg-bw)

a. Birds

Before the two RQ types are calculated for birds, the EECs and toxicity values are adjusted based 

on food intake and body weight differences so that they are comparable for a given weight class of 

animal. The size classes assessed are small (20-gram), medium (100-gram), and large (1000-

gram) birds. For birds, only acute values (LD50s) are adjusted because dose-based risk quotients 

are not calculated for the chronic risk estimation. The avian LD50 of 616 mg/kg-bw is used in this 

assessment to derive acute dose-based risk quotients. However, extrapolation from one bird to 

another needs to consider differences in the scaling of toxicity for differences in body weight. 
72

Therefore, the red-legged partridge LD50 of 616 mg/kg-bw is adjusted for birds of various sizes 

based on the following formula, recommended by Mineau et al. 1996:

 Adj. LD50 = LD50 (AW/TW) (a-1)

where adj. LD50 is the median 50% lethal dose for the species being assessed, LD50 is the median 

lethal dose in the test organism, AW is the body weight of the assessed organism, TW is the body

weight for the test organism, and a is the slope of the regression line for estimating the assessed 

species LD50 from the test species LD50 (EFED default value of 1.15). Adjusted LD50s are 

calculated for small (20-gram), medium (100-gram), and large (1000-gram) birds. The test 

organism is a red-legged partridge with an average body weight of 0.43 kg (430 grams) in the 

control group of the study. The resulting adjusted LD50s are in Table IV-17 below. 

Table IV-17. Adjusted Avian LD50s for 20-, 100-, and 1000-gram Birds Based on an LD50 of 616 

mg/kg-bw in Red-legged Partridge.

Avian

Class

Body 

Weight

Adjusted

LD50

Small 20 389

Mid 100 495

Large 1000 699

Acute Risk Quotients of the AI alone

Table III-18 presents the avian dose-based RQs for the AI alone on apples and soybeans. For 

apple uses, the dose-based RQs of 0.25, 0.12, and 0.14 exceed the acute LOCs for 20 g birds 

consuming short grass, tall grass, and broadleaf forage/small insects and the dose-based RQ of 

0.11 exceeds the acute LOC for 100 g birds consuming short grass. For small-sized (20g) birds 

consuming short grass, the restricted use and endangered species LOCs are exceeded. The 

endangered species LOC is also exceeded for 20 g birds consuming the assessed food items except 

fruits, pods, seeds, and large insects. For mid-sized (100 g) birds consuming short grass, the 

endangered species LOC is exceeded; the acute LOCs are not exceed for 100 g birds consuming 

tall grass, broadleaf forage, small insects, fruits, pods, seeds, and large insects. There is no 

exceedance of the acute LOCs for large-sized (1000 g) birds consuming any of the assessed food 

items based on a maximum application of 0.11 applied 4 times with 7 day reapplication intervals. 

For soybean uses and dose-based RQs, there is an exceedances of the avian acute endangered 

species LOC for 20 g birds consuming maximum predicted residues of the AI on short grass based 

on a maximum application of 0.06 lbs ai/A applied 3 times with 14 day reapplication intervals. On 

the other hand, there is no exceedance of the acute LOCs for medium- and large-sized birds

feeding on any of the assessed feed items or small-sized birds feeding on tall grass, broadleaf 

plant, small and large insects, and seeds based on 3 applications of 0.06 lb ai/A with 14-day

reapplication intervals. There is no exceedance for all weight classes of birds feeding in or near a 

soybean field when the reapplication interval is increased to 21 days from 14 days.

These LOC exceedances indicate that small- and medium-sized birds may be at risk for adverse 

effects on survival from exposure to the AI alone as a result of the labeled uses of the pesticide. 

Potential acute risk to birds is discussed further in the Risk Description section.
73

Table IV-18. Upper Bound Kenaga, Flutriafol Acute Avian Dose-Based Risk Quotients for Apple and 

Soybean Uses

Site

Size 

Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

Apple

20 389 99 0.25** 45 0.12* 56 0.14* 6 0.02

100 495 56 0.11* 26 0.05 32 0.06 4 0.01

1000 699 25 0.04 12 0.02 14 0.02 2 <0.01

Soybean

(14-day 

intervals)

20 389 38 0.1* 18 0.05 22 0.06 3 <0.01

100 495 22 0.05 10 0.02 12 0.03 1 <0.01

1000 699 10 0.01 5 0.01 6 0.01 0.6 <0.01

Soybean 

(21-day 

intervals)

20 389 34 0.09 16 0.04 19 0.05 2 <0.01

100 495 20 0.04 9 0.02 11 0.02 1 <0.01

1000 699 9 0.01 4 0.01 5 0.01 0.6 <0.01

Bold value indicates LOC exceedance (**exceeds the LOC of 0.2 for restricted use and LOC of 0.1 for 

endangered species; *exceeds the LOC of 0.1 for endangered species)

Table IV-19 presents the avian dietary-based RQs for the AI alone on apples and soybeans. For 

apple and soybean uses, the dietary-based RQs from acute exposure of the AI alone to birds are all 

≤0.02. Therefore, there are no exceedances of the avian acute LOC for birds consuming the 

maximum predicted residues on these food items. 

Table IV-19. Upper Bound Kenaga, Flutriafol Subacute Avian Dietary Based Risk Quotients 

for Apple and Soybean Uses

Site LC50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

Apple 4062 87 0.02 40 0.01 49 0.01 5 <0.01

Soybean

(14-day 

intervals) 4062 32 0.01 14.5 <0.01 18 <0.01 2 <0.01

Soybean

(21-day 

intervals) 4062 30 0.01 14 <0.01 17 <0.01 2 <0.01

Size class not used for dietary risk quotients 

Chronic Risk Quotients of the AI alone

To evaluate the chronic risk of the AI alone to birds, dietary-based RQs are calculated using the 

mallard duck NOAEC of 39.2 mg/kg-diet. The RQs are detailed in Table IV-20 and in Appendix 

D.

The RQs of 2.21, 1.01, and 1.25 for the proposed use of the AI alone on apples exceeds the LOC 

for chronic risk to birds consuming short grass, tall grass, and broadleaf plants and small insects, 
74

respectively. These exceedances indicate that birds may be at risk for adverse chronic effects to 

reproduction from chronic exposure to the AI alone as a result of the labeled apple uses. These 

chronic risks to birds are discussed further in the Risk Description section. For the soybean use 

scenarios modeled (Table IV-20), there are no chronic LOC exceedances for birds consuming any

of the assessed food items in soybean fields. 

Table IV-20. Upper Bound Kenaga, Flutriafol Chronic Avian Dietary Based Risk Quotients for Apple 

and Soybean Uses

Site NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

Apple 39.2 87 2.21* 40 1.01* 49 1.25* 5 0.14

Soybean 

(14D interval) 39.2 32 0.86 14.5 0.39 18 0.48 2 0.05

Soybean

(21D interval) 39.2 30 0.77 14 0.35 17 0.43 2 0.05

Size class not used for dietary risk quotients

Bold values indicate LOC exceedances (*exceeds the LOC of 1 for chronic risk)

b. Mammals

Using similar methodology to that employed for birds, the female mouse LD50 of 179 mg/kg-bw

and the rat NOAEL of 20.6 mg/kg day/bw are adjusted to allow for an assessment of risk to 

mammals of various sizes based on the following formula, which was recommended by Mineau et 

al. 1996: 

Adj. LD50 or NOAEL = LD50 or NOAEL (TW/AW)0.25

LD50, TW, and AW were previously defined. Adjusted LD50s and NOAELs are calculated for 

small (15-gram), medium (35-gram), and large (1000-gram) mammals. The test organisms are a 

mouse and a rat with a reference body weight of 20 and 350 grams, respectively. The resulting 

adjusted LD50s and NOAELs are in Table IV-21 below. 

Table IV-21. Adjusted Mammalian LD50s and NOAELs for 15-, 35-, and 1000-gram Mammals 

Based on an Female Mouse LD50 of 179 and NOAEL of 240 mg/kg-diet and 20.6 mg/kg/day-bw in 

Female Rat

Mammalian

Class

Body

Weight Adjusted LD50 Adjusted NOAEL

Small 15 192 45

Mid 35 156 37

Large 1000 67 16

Acute Risk Quotients of the AI alone

For both proposed uses on apple and soybean, the dose-based RQs for the AI alone exceeded the 

acute LOCs for all weight classes of mammals consuming short grass with the exception of 1000 g 
75

birds consuming short grass in soybean sites. In Table IV-22, the RQs for the AI alone are as high 

as 0.4 which exceeds the restricted use and endangered species LOCs for mammals consuming 

short grass in apple sites. For apple use, the RQs of 0.1 – 0.2 for mammals consuming tall grass 

and RQs of 0.2 – 0.24 for mammals consuming broadleaf plants/small insects, with the exception 

of 1000 g mammals consuming tall grass, exceeds the acute restricted use and endangered species

LOCs. For 1000 g mammals consuming tall grass, only the endangered species LOC is exceeded. 

The dose-based RQs for all weight classes of mammals consuming fruits, pods, and large insects 

and granivores are <0.03 and do not exceed the acute LOCs. These exceedances indicate that 

mammals may be at risk for adverse effects on survival from acute exposure to the AI alone as a 

result of the labeled uses of the pesticide and will be discussed in the Risk Description section.

Dietary-based RQs are not estimated for mammals since acute dietary mammal studies are not 

available.

Table IV-22. Upper Bound Kenaga, Flutriafol Acute Mammalian Dose-Based Risk Quotients For Apple and 

Soybean Uses

Site

Size 

Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

Apple

15 192 83 0.4** 38 0.2** 47 0.24** 5 0.03 1 0.01

35 156 57 0.4** 26 0.2** 32 0.2** 4 0.02 1 <0.01

1000 67 13 0.2** 6 0.1* 7 0.1* 1 0.01 0.2 <0.01

Soybean 

(14-day 

intervals)

15 192 32 0.2** 14.5 0.08 18 0.09 2 0.01 0.4 0.00

35 156 22.1 0.1** 10.1 0.07 12.5 0.08 1.4 0.01 0.3 0.00

1000 67 5.1 0.08 2.4 0.03 2.9 0.04 0.32 0.00 0.07 0.00

Soybean

(21-day 

intervals)

15 192 29 0.2** 13 0.07 16 0.08 2 0.01 0.4 <0.01

35 156 20 0.1* 9 0.06 11 0.07 1 <0.01 0.3 <0.01

1000 67 5 0.07 2 0.03 3 0.04 0.3 <0.01 0.06 <0.01

Bold value indicates LOC exceedance (***exceeds the LOC of 0.5 for acute, restricted use, and endangered species; 

**exceeds the LOC of 0.2 for restricted use and endangered species; *exceeds the LOC of 0.1 for endangered species)

Acute Risk Quotients of the Formulated Product itself

A definitive acute toxicity threshold was not established for mammals exposed to the formulated

product (acute LC50 >2000 mg form/kg); consequently, RQs are not quantitatively estimated and 

are discussed further in the Risk Description section.

Chronic Risk Quotients of the AI alone

To evaluate the chronic risk to mammals, dose-based and dietary-based RQs for the AI alone are

calculated using the rat NOAEL of 20.6 mg/kg bw/day and NOAEC of 240 mg/kg-diet from the 2-

generation study in rats. The dose-based RQs are detailed in Table IV-23 and in Appendix D. The 

dietary-based RQs are detailed in Appendix D. 

Assuming maximum residue levels of the proposed uses, the dietary-based risk quotients of the AI 

alone do not exceed the chronic LOC for mammals. However, the dose-based risk quotients for the

15 g and 35 g weight classes of mammals exceed the chronic risk LOC of 1. The chronic LOC of 
76

the AI alone is exceeded for 15 g and 35 g mammals consuming short grass and exceeded for 15 g 

mammals consuming broadleaf plants and small insects in apple sites. These exceedances indicate 

that mammals may be at risk for adverse effects on reproduction and growth from chronic

exposure to the AI alone as a result of the labeled uses for apples and will be discussed in the Risk 

Description section.

For soybean uses and dose-based RQs, there are no chronic LOC exceedances for mammals of all 

weight classes consuming any of the food items. 

Table IV-23. Upper Bound Kenaga, Flutriafol Chronic Mammalian Dose-Based Risk Quotients for Apple and 

Soybean Uses

Site

Size 

Class

(grams)

Adjusted 

NOAEL

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large 

Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

Apple

15 45 83 1.8 38 0.84 47 1.0 5 0.1 1 0.03

35 37 57 1.6 26 0.7 32 0.88 4 0.1 1 0.02

1000 16 13 0.84 6 0.4 7 0.5 1 0.05 0.2 0.01

Soybean 

(14-day 

intervals)

15 45 32.0 0.08 14.7 0.04 18 0.05 2 0.01 0.44 0.00

35 37 22.1 0.07 10.1 0.03 12.5 0.04 1.4 0.00 0.31 0.00

1000 16 5.1 0.04 2.4 0.02 2.9 0.02 0.32 0.00 0.07 0.00

Soybean 

(21-day 

intervals)

15 45 29 0.6 13 0.3 16 0.3 2 0.04 0.4 0.01

35 37 20 0.5 9 0.2 11 0.3 1 0.03 0.3 0.01

1000 16 5 0.3 2 0.1 3 0.2 0.3 0.02 0.06 <0.01

Bold values indicate LOC exceedances (excess the LOC of 1 for chronic risk)

c. Terrestrial-phase Amphibians and Reptiles

EFED currently uses surrogate data (birds) for terrestrial amphibians and reptiles. Risks are 

qualitatively discussed in the Risk Description section.

d. Beneficial Insects

Potential risks to beneficial insects are discussed in the Risk Description section of this document.

3. Non-target Terrestrial Plants in Terrestrial and Semi-aquatic Environments

Table IV-24 presents the toxicity endpoint values used to calculate RQs and estimate risk to 

terrestrial receptors from flutriafol residues as a result of direct deposition and spray drift from 

ground and aerial applications. Details of the RQ calculations for terrestrial plants are provided 

below and in Appendix E. The potential risks to terrestrial plants are discussed further in the Risk 

Description section. 
77

Table IV-24. Flutriafol 125 g/L SC Toxicity Endpoint Values for Assessing Risk to Terrestrial Plants

Exposure 

Scenario

Species Exposure 

Duration

Toxicity Endpoint 

Value

Endpoint Reference 

(Classification)

Terrestrial Plants

Seedling 

Emergence

Monocot –

ryegrass

21-day 

EC25 >0.12 lb ai/A; 

NOAEC >0.12 lb ai/A None MRID 47090328

(Acceptable) Dicot –

soybean 

EC25 >0.12 lb ai/A; 

NOAEC >0.12 lb ai/A None

Vegetative 

Vigor

Monocot -

ryegrass

EC25 >0.12 lb ai/A; 

NOAEC >0.12 lb ai/A None MRID 47090329

(Acceptable) Dicot – sugar 

beet

EC25 >0.12 lb ai/A; 

NOAEC >0.12 lb ai/A None

Risk Quotients of the AI in its Formulated Product to Non-Listed and Listed Monocots and Dicots

Table IV-25 presents RQs for the formulated product of flutriafol to terrestrial plants via ground 

and aerial spray applications. For the proposed new uses of flutriafol and the maximum application 

rates of 0.06 and 0.11 lbs ai/A, both non-listed and listed LOCs are not exceeded for all monocots 

and dicots located adjacent to treated areas, in semi-aquatic areas, and as a result of off site runoff 

and/or spray drift. 

Table IV-25. Terrestrial Plant Risk Quotient Summary for Flutriafol 125 g/L SC 1,2,3,4

Scenario

Non-listed RQs Listed RQs

Terrestrial

Adjacent area

Semi-aquatic 

Adjacent area Drift TerrestrialAdjacent area

Semi-aquatic 

Adjacent area

Drift

Maximum Rate for Apples (0.11 lb ai/A)

Ground spray

Monocot <0.1 <0.47 <0.1 <0.1 <0.47 <0.1

Dicot <0.1 <0.47 <0.1 <0.1 <0.47 <0.1

Maximum Rate for Soybeans (0.06 lb ai/A)

Ground spray

Monocot <0.1 <0.26 <0.1 <0.1 <0.26 <0.1

Dicot <0.1 <0.26 <0.1 <0.1 <0.26 <0.1

Aerial spray

Monocot <0.1 <0.28 <0.1 <0.1 <0.28 <0.1

Dicot <0.1 <0.28 <0.1 <0.1 <0.28 <0.1

1Detailed calculations for RQs and TerrPlant Ver. 1.2.2 input and output are provided in Appendix E.

2 RQs for ground and/or aerial spray applications in this table were calculated for the maximum application rates 

for each uses.

3 Non-listed toxicity thresholds (EC25) were all >0.12 lb ai/A for seedling emergence monocot, seedling emergence 

dicot, vegetative vigor monocot, and vegetative vigor dicot. 

4 Listed toxicity thresholds (NOAEC/EC05) were all > 0.12 lb ai/A for seedling emergence monocot, seedling 

emergence dicot, vegetative vigor dicot And vegetative vigor monocot.

B. Risk Description

The risk hypothesis states that the use of flutriafol and its formulated product as a fungicide for 

terrestrial crop sites has the potential to adversely affect survival, reproduction, and/or growth of 
78

non-target aquatic and terrestrial animals and plants, including Federally-listed endangered and 

threatened species. Based on the available ecotoxicity data and predicted environmental 

exposures, risks may occur to the following taxonomic groups based on the proposed new uses of 

the AI alone and/or its formulated product of flutriafol:

Apples (4 applications @ 0.11 lb ai/A with 7-day intervals)

The acute endangered species level of concern (LOC) is estimated to be exceeded for these taxa

when ground applied to apple sites:

 acute dose-based exposure of the AI alone to 20 g birds (including terrestrial-phase 

amphibians and reptiles) feeding on short grass, tall grass, broadleaf forage, and small 

insects,

 acute dose-based exposure of the AI alone to 100 g birds (including terrestrial-phase 

amphibians and reptiles) feeding on short grass, and

 acute dose-based exposure of the AI alone to 15 g, 35 g, and 1000 g mammals feeding on 

short grass, tall grass, broadleaf forage and small insects, 

The acute restricted use level LOC is estimated to be exceeded for these taxa when ground applied 

to apple sites:

 acute dose-based exposure of the AI alone to 20 g birds (including terrestrial-phase 

amphibians and reptiles) feeding on short grass,

 acute dose-based exposure of the AI alone to 15 g and 35 g mammals feeding on short 

grass, tall grass, broadleaf forage and small insects, and

 acute dose-based exposure of the AI alone to 1000 g mammals feeding on short grass 

The chronic risk LOC is estimated to be exceeded for these taxa when ground applied to apple 

sites:

 chronic dietary-based exposure of the AI alone to birds (including terrestrial-phase 

amphibians and reptiles) feeding on short grass, tall grass, and broadleaf plants and small 

insects,

 chronic dose-based exposure of the AI alone to 15 g mammals feeding on short grass, 

broadleaf plants and small insects, and

 chronic dose-based exposure of the AI alone to 35 g mammals feeding on short grass, , 

Soybeans (3 applications @ 0.06 lb ai/A with 14-day intervals)

The acute endangered species LOC is estimated to be exceeded for these taxa when ground or 

aerially applied to soybean sites:

 acute dose-based exposure of the AI alone to 20 g birds feeding on short grass and

 acute dose-based exposure of the AI alone to 15 g and 35 g mammals feeding on short 

grass
79

Soybeans (3 applications @ 0.06 lb ai/A with 21-day intervals)

The acute endangered species LOC is estimated to be exceeded for these taxa when ground or 

aerially applied to soybean sites:

 acute dose-based exposure of the AI alone to 15 g and 35 g mammals feeding on short 

grass

The acute restricted use LOC is estimated to be exceeded for these taxa when ground or aerially 

applied to soybean sites:

 acute dose-based exposure of the AI alone to 15 g mammals feeding on short grass

Apples and Soybeans

However, the AI alone and its formulated product do not exceed the endangered species LOCs for 

the following group(s):

 acute and chronic exposures to freshwater fish (including aquatic-phase amphibians),

 acute and chronic exposures to estuarine/marine fish, 

 acute exposure to freshwater invertebrates, 

 exposure to non-listed aquatic vascular and nonvascular plants, 

 exposure to listed aquatic vascular and nonvascular plants, and

 exposure to non-listed and listed terrestrial plants 

1. Risks to Aquatic Animals and Plants 

In the conceptual model, spray drift and surface runoff/leaching to adjacent bodies of water are

predicted as the most likely sources of exposure of flutriafol to non-target aquatic animals and 

plants. Risks to aquatic species (i.e. fish, invertebrates, and plants) are assessed based on modeled 

estimated environmental concentrations (EECs) and available toxicity data. The aquatic EECs for 

the ecological exposure to the acute and chronic toxicity values of the AI alone are estimated using 

GENEEC2 (Table III-5) or PRZM/EXAMs (Table III-7), while the ecological exposure to the 

acute toxicity of the formulated product itself is estimated using AgDRIFT (Table III-10).

For fish and invertebrates, the first part focuses on the risk of the active ingredient alone to these 

species. The latter parts focus on the risks of the formulated product itself to these species because 

it appears that Flutriafol 125 g/L SC is more toxic than the active ingredient alone to aquatic 

species. For aquatic plants, risk is assessed based on the active ingredient in its formulated product.

a. Aquatic Animals

Acute Risk to Freshwater and Estuarine/marine Fish

(1) Acute Risk of the AI Alone to Fish
80

Available acute toxicity data indicates that the AI alone is slightly toxic to freshwater fish and no 

more than slightly toxic to estuarine/marine fish on an acute basis. The acute RQs based on the AI

alone for freshwater fish are all <0.01 and do not exceed the acute listed LOC of 0.05. Acute RQs 

for estuarine/marine fish exposed to the AI alone are not quantitatively calculated; in order to 

compare these acute values for freshwater and estuarine/marine fish with an exposure value, the 

highest peak GENEEC EEC of 0.021 mg ai/L in surface water is selected from the apple use 

scenario. A comparison of the ecotoxicity values of the AI alone listed above (LC50 values ranging 

from 33 – >72.2 mg ai/L) with the peak GENEEC EEC (0.021 mg ai/L), indicates a 1500 to 3400-

fold difference between the highest peak EEC and the concentrations which produced a lethal 

effect on 50% of the fish species. The fish LC50 value of the AI alone would need to be ≤0.42 mg

ai/L to yield an RQ that exceeds the acute endangered LOC of 0.05.

(2) Acute Risk of the Formulated Product itself to Fish

Risk to aquatic receptors from exposure to the formulated product containing the active and inert 

ingredients is estimated through spray drift alone. The LC50 values for freshwater and 

estuarine/marine fish exposed to the formulated product itself range from 7.9 mg form/L to >17 

mg form/L. A comparison of ecotoxicity values of the formulation with the highest AgDRIFT 

EEC for the soybean aerial scenario (0.0036 mg form/L) for Flutriafol 125 g/L SC indicates a 2200 

to 4722-fold difference between the highest AgDRIFT EEC and the concentrations which 

produced a lethal effect on 50% of the fish species. A fish LC50 of the formulated product would 

need to be ≤0.072 mg form/L to yield an RQ that exceeds the acute endangered LOC of 0.05. 

(4) Acute Risk Summary for Fish Exposed to the AI alone and to its 

Formulated Product

Based on the available information, this ecological risk assessment for freshwater and 

estuarine/marine fish, including Federally-listed endangered and threatened species, suggests there 

is no indication of risk for adverse effects on survival to fish, both freshwater and estuarine/marine 

species, from acute exposure to flutriafol and its formulated product as a result of the labeled uses 

(Appendix C). There is some uncertainty regarding the acute to acute ratio (AAR) value from 

different fish species to evaluate the acute risk of the formulated product to estuarine/marine fish; 

however, if estuarine/marine fish survival studies are submitted and are more or less toxic than 

estimated, then risks may be under- or over-estimated, respectively, for this taxonomic group. The 

submission of acute Flutriafol 125 g/L SC data with estuarine/marine fish would be useful in 

reducing the uncertainty. 

Chronic Risk to Freshwater and Estuarine/marine Fish

(1) Chronic Risk of the AI alone to Fish

Following chronic exposure to the AI alone, the NOAEC for freshwater fish is 4.8 mg ai/L based 

on significant reductions of post-hatch survival and the estimated NOAEC value for 

estuarine/marine fish is >11 mg ai/L. Chronic risk quotients for the AI alone to freshwater and 

estuarine/marine are well below the chronic LOC. A comparison of the NOAECs of the AI alone 
81

with the highest 60-day GENEEC EEC (0.021 mg ai/L) indicates a 154 to 354-fold difference 

between the EEC and the concentrations that produced no significant reproductive or growth 

effects. A fish NOAEC value of the AI alone would need to be ≤0.029 mg ai/L to yield an RQ that 

exceeds the chronic risk LOC of 1.0. 

(2) Chronic Risk Summary for Fish Exposed to the AI alone 

Consequently, freshwater and estuarine/marine fish species are not at risk for adverse effects on

reproduction and growth from exposure to the AI alone. Similar to the acute risks for fish, there is 

some uncertainty regarding the acute to chronic ratio (ACR) value derived from different fish

species to evaluate the chronic risk of AI alone to estuarine/marine fish. However, if 

estuarine/marine fish early life-stage studies with the AI alone are submitted and are more 

sensitive than estimated, then risks may be underestimated for this taxonomic group. The 

submission of chronic toxicity data with estuarine/marine fish would be useful in reducing the 

uncertainty. 

Acute Risk to Freshwater and Estuarine/marine Invertebrates

(1) Acute Risk of the AI Alone to Invertebrates

Flutriafol, the active ingredient, is slightly toxic to both invertebrate species. Based on the most 

conservative aquatic exposure scenario for the AI alone, the peak GENEEC EEC is 0.021 mg ai/L. 

Compared to the daphnid and oyster acute toxicity values of 67 and 25 mg ai/L, respectively, the 

RQs are <0.01 and do not exceed the acute listed species LOC of 0.05. A comparison of the 

ecotoxicity values of the AI alone listed above (acute toxicity values ranging between 25 – 67 mg 

ai/L) with peak GENEEC EEC in surface water (0.021 mg ai/L) indicates a 1190 to 3100-fold 

difference between the EEC and the concentrations which produced an effective concentration on 

50% of the invertebrate species. An invertebrate EC50 value of the AI alone would need to be 

≤0.42 mg ai/L to yield an RQ that exceeds the acute endangered LOC of 0.05.

(2) Acute Risk of the Formulated Product itself to Invertebrates

Risk to aquatic receptors from exposure to the formulated product containing the active and inert 

ingredients is estimated through spray drift alone. The EC50 values for freshwater and 

estuarine/marine invertebrates exposed to the formulated product itself range from 2.5 mg form/L 

to 7.0 mg form/L. A comparison of ecotoxicity values of the formulation itself with the highest 

AgDRIFT EEC for the soybean aerial scenario (0.0036 mg form/L) for Flutriafol 125 g/L SC 

indicates a 694 to 1944-fold difference between the highest AgDRIFT EEC and the concentrations 

which produced an immobility effect on 50% of the invertebrates species. An invertebrate EC50 

value of the formulated product itself would need to be ≤0.072 mg form/L to yield an RQ that 

exceeds the acute endangered LOC of 0.05. 

(3) Acute Risk Summary for Invertebrates Exposed to the AI Alone 

and to its Formulated Product
82

Based on the available information, this ecological risk assessment for freshwater and 

estuarine/marine invertebrates, including Federally-listed endangered and threatened species, 

suggests that risk of adverse effects at levels that exceed LOCs to survival to invertebrates is 

expected to be minimal for freshwater and estuarine/marine species, from acute exposure to the AI 

alone. 

For the formulated product itself, the acute risks to invertebrates inhabiting water bodies adjacent 

to treated apple and soybean fields are expected to be minimal. 

Similar to the risks for fish, there is some uncertainty regarding the AAR value derived from 

different invertebrate species to evaluate the acute risk of the formulated product to 

estuarine/marine invertebrates. However, if estuarine/marine invertebrate survival studies with the 

formulated product (Flutriafol 125 g/L SC) are submitted and are more or less sensitive than 

estimated, then risks may be under- or over-estimated, respectively, for this taxonomic group. The 

submission of acute toxicity data using Flutriafol 125 g/L SC with estuarine/marine invertebrates

would be useful in reducing the uncertainty.

Chronic Risk to Freshwater and Estuarine/marine Invertebrates

(1) Chronic Risk of the AI Alone to Invertebrates

Following chronic exposure to the AI alone, the NOAEC for freshwater invertebrates is 0.31 mg 

ai/L based on significant reductions of growth and reproduction and the estimated NOAEC value 

for estuarine/marine invertebrates, based on an ACR of 216, is 0.12 mg ai/L. There are no chronic 

LOC exceedances for freshwater and estuarine/marine invertebrates based on the most 

conservative aquatic exposure scenarios; thus, freshwater invertebrates, including Federally-listed 

endangered and threatened species, there is no indication for adverse effects on reproduction and 

growth at levels that exceed LOCs from chronic exposure to the active ingredient alone. An 

invertebrate NOAEC of the AI alone would need to be ≤0.029 mg ai/L to yield an RQ that exceeds 

the chronic risk LOC of 1.0. 

(2) Chronic Risk Summary for Invertebrates Exposed to the AI 

Alone 

Based on the available information, this ecological risk assessment for freshwater and 

estuarine/marine invertebrates, including Federally-listed endangered and threatened species, 

suggests there is no indication of risk for adverse effects on reproduction and growth to 

invertebrates, both freshwater and estuarine/marine species, from chronic exposure to the AI alone.

b. Aquatic Plants

Risk to Non-listed Plants

(1) The Risks of the AI in its Formulated Product to Non-listed 

Aquatic Plants
83

The non-listed toxicity values of the AI in its product for non-listed aquatic vascular and 

nonvascular plants are 0.78 mg ai/L and 0.46 mg ai/L, respectively. Based on the most 

conservative exposure scenario and peak GENEEC EECs, the non-listed plant RQs of <0.1 do not 

exceed the LOC for non-listed aquatic vascular and nonvascular plants adjacent to soybean and 

apple sites exposed to the AI in its product (Flutriafol 125 g/L SC) as a result of runoff and spray

drift. 

(2) The Risks of the Formulated Product itself to Non-listed Aquatic 

Plants

Risk to non-listed aquatic plants from exposure to the formulated product containing the active and 

inert ingredients is estimated through spray drift alone. The EC50 values of the formulated product 

itself for non-listed aquatic vascular and nonvascular plants are 6.6 mg form/L and 3.9 mg form/L, 

respectively. A comparison of the ecotoxicity values of the formulation with the highest AgDRIFT 

EEC for the soybean aerial scenario (0.0036 mg form/L), the RQs are <0.1 and do not exceed the 

LOC for non-listed aquatic vascular and nonvascular plants as a result of spray drift.

Risk to Listed Plants

(1) The Risks of the AI in its Formulated Product to Listed Aquatic 

Plants

The listed toxicity values of the AI in its product for listed aquatic vascular and nonvascular plants 

are 0.018 mg ai/L and 0.1 mg ai/L, respectively. Based on the most conservative exposure scenario 

and peak GENEEC EECs, the RQs of <0.6 do not exceed the LOC for listed aquatic vascular and 

nonvascular plants adjacent to soybean sites exposed to the AI in its product as a result of runoff 

and spray drift. Based on the refined exposure scenario and peak PRZM/EXAMs EECs, the RQs 

of <0.6 do not exceed the LOC for listed aquatic vascular and nonvascular plants adjacent to apple 

sites. 

(2) The Risks of the Formulated Product itself to Listed Aquatic 

Plants

Risk to listed aquatic plants from exposure to the formulated product containing the active and 

inert ingredients is estimated through spray drift alone. The EC50 values of the formulated product

itself for listed aquatic vascular and nonvascular plants are 6.6 mg form/L and 3.9 mg form/L, 

respectively. A comparison of the ecotoxicity values of the formulation with the highest AgDRIFT 

EEC for the soybean aerial scenario (0.0036 mg form/L), the RQs are <0.1 and do not exceed the 

LOC for listed aquatic vascular and nonvascular plants as a result of spray drift. 

(4) Summary of the Risks to Aquatic Plants Exposed to the AI in its 

Formulated Product and to the Formulated Product itself

This ecological risk assessment for aquatic plants, including Federally-listed endangered and 

threatened species, suggests that listed aquatic plants inhabiting water bodies adjacent to treated 
84

apple and soybean sites are unlikely to be at risk for adverse effects on survival and growth from 

exposure to the AI in its product and the formulated product itself. 

In addition, there is uncertainty regarding the toxicity value used on the assumption that the 

formulation inerts in the formulated product is more toxic than the AI to evaluate the risk of the AI

alone to aquatic plants. The submission of toxicity data with the AI alone with aquatic plants

would be useful in reducing the uncertainty.

c. Aquatic-phase Amphibians

EFED currently uses surrogate data (freshwater fish) for non-target aquatic amphibians. 

Freshwater fish risk data indicates that aquatic-phase amphibians are not anticipated to be at risk 

for adverse effects on survival, growth, and reproduction from exposures to the AI alone (acute 

and chronic) as a result of runoff and spray drift or its formulated product (acute only) as a result 

of spray drift to adjacent water bodies following flutriafol treatments in soybean and apple sites.

Thus, there is no indication of risk for adverse effects on survival, reproduction, and growth to 

aquatic-phase amphibians exposed to the active ingredient of flutriafol.

2. Risks to Terrestrial Animals and Plants 

In the conceptual model, dietary ingestion of flutriafol residues on vegetative matter and insects on 

treated areas and off-site spray drift and runoff of the residues to low-lying untreated areas are

predicted as the most likely sources of exposure of flutriafol to non-target terrestrial animals and 

plants. Risks to terrestrial species (i.e. birds, mammals and plants) are assessed based on modeled 

estimated environmental concentrations (EECs) and available toxicity data. Terrestrial EECs for 

the ecological exposure to the acute and chronic toxicity values of the AI alone are estimated using 

T-REX (Table III-6, -7, and -8) and TerrPlant (Table III-9); for the ecological exposure to the

acute toxicity of the formulated product itself is estimated using AgDRIFT (Table III-10).

Mammal toxicity data with the formulated product (Flutriafol 125 g/L SC) is available for 

evaluation in this ecological risk assessment. Thus, for mammals, the first part focuses on the risk 

of the AI alone to mammals; then, the latter parts focus on the risks of the formulated product to 

mammals. 

a. Terrestrial Animals 

Acute Risk to Birds

For spraying in apple sites, the dose-based RQs of 0.11 - 0.25 exceed the acute restricted use and 

endangered species LOCs for small-sized (20 g) and medium-sized (100 g) birds consuming short 

grass and/or tall grass, broadleaf forage, and small insects with residues of the AI alone. No acute 

LOC exceedances for large-sized (1000 g) birds and those birds that forage mainly on fruits, pods, 

seeds, and large insects with residues of the AI alone. Small and medium sized birds may be at risk 

for adverse effects on survival from acute exposure to AI residues alone as a result of the labeled 

uses for control of scab, powdery mildew, or quince or cedar apple rust on apples. In addition, the 
85

RQs from mean Kenaga EECs indicate no exceedance of the LOC for 20 g birds foraging any of 

the feed items with AI residues alone.

For spraying in soybean fields using the 14-day reapplication interval, the dose-based RQ of 0.1 

exceeds the acute endangered species LOC for small-sized birds feeding on short grass with 

residues of the AI alone. There is no exceedance of the acute LOCs for small-sized bird feeding on 

tall grass, broadleaf plants, large and small insects, and seeds and for medium- and large-sized 

birds feeding on any of the assessed food items. When the reapplication interval is increased to 21 

days, for soybean use, there are no acute LOC exceedances for all weight classes of birds foraging 

food items with residues of the AI alone. The RQs from mean Kenaga EECs did not exceed the 

LOCs for acute risk to birds in soybean fields.

Although there is an exceedance of the acute LOC, the potential risk for adverse effects on

survival is based on the assumption that small- and medium-sized birds are feeding exclusively

within agricultural areas where apples and soybeans are grown. The exceedance to birds following 

flutriafol treatments is based on the assumption that birds occupy, exclusively and permanently, 

the area of apple and soybean uses, and forage on feed items with AI residues alone. To the extent 

that those birds do not reside exclusively and permanently within the use area, exposure will be 

less and risk is presumably less.

In addition, the risks to passerine bird species forging in or nearby treated areas cannot be 

precluded at this time. Until toxicity data is submitted, the potential impact to passerine birds to 

flutriafol is uncertain and these birds are assumed to be directly affected by the active ingredient as 

well.

The maximum use scenario for apples in this baseline risk assessment assumes four applications of 

flutriafol per season at 0.11 lbs ai/A and 7-day reapplication intervals to birds. For 20 g birds 

feeding on short grass, there is a potential for risk if flutriafol is applied two or more times and for 

20 g birds feeding on tall grass, broadleaf plants, and small insects, it requires three or more 

applications of the AI alone to exceed the LOC. It requires four or more applications for potential 

risk to 100 g birds feeding on short grass with residues of the AI alone. For soybeans, the increase 

of the reapplication interval to 21 days from 14 days results in no acute LOC exceedances for 

birds.

In an effort to characterize the potential risk to birds based on dietary exposures from apple and 

soybean uses, dietary-based EECs were estimated and compared to the LC50 of the AI alone. The 

subacute toxicity value of 4082 mg/kg-diet is compared to predicted avian doses on food residues

of the AI alone. The dietary-based RQs of <0.01 – 0.3 do not exceed the acute LOCs for birds 

foraging vegetative matter and insects with flutriafol residues. Thus, avian species residing in

soybean sites are not at risk to adverse effects on survival from acute dietary exposure to the AI 

alone as a result of the labeled uses.

The acute risks to birds from the formulated product itself are not estimated since bird acute 

studies with the formulated product or extrapolated values are not available. However, mammal

acute data with the formulated product suggest the product is less toxic than the AI; it is possible 
86

that birds are not at risk to the formulated product, Flutriafol 125 g/L SC. Submission of acute 

studies of the formulated product with birds would be helpful in removing the uncertainty. 

Chronic Risk to Birds

For spraying in apple sites per label and maximum predicted residue levels (upper bound EECs), 

the chronic RQs of 1.0 – 2.2 exceed the chronic risk LOC (LOC >1.0) for birds feeding on short 

grass, tall grass, broadleaf forage/small insects with residues of the AI alone. For applications of 

flutriafol to soybeans, there is no exceedance of the chronic risk LOC for birds feeding on any of 

the assessed food items with residues of the AI alone. Furthermore, there are no LOC exceedances 

for birds foraging fruits, pods, seeds or large insects with flutriafol residues in apple or soybean 

sites. 

In an effort to further characterize the potential risk to birds from applications to apples (0.11 lb 

ai/A x 4 applications with 7D intervals) and soybeans (0.06 lb ai/A x 3 applications with 21D 

intervals and 0.06 lb ai/A x 3 applications x 14D intervals), terrestrial dietary exposures of the AI 

alone were estimated and compared to the NOAEC of 39.2 mg ai/kg-diet. On the other hand, the 

chronic RQs for the soybeans were 0.05 to 0.86, which are lower than the LOC of 1. Thus, birds

are at risk for adverse effects on growth and reproduction from chronic dietary exposure to the AI 

alone as a result of the apple use, but not for soybean use. Although there is an exceedance of the 

chronic LOC, the potential risk for adverse effects on growth and reproduction is based on the 

assumption that birds are feeding exclusively within agricultural areas where apples are grown. 

The exceedance to birds following applications to apples is based on the assumption that birds 

occupy, exclusively and permanently, the area of proposed use, and foraging feed items with 

flutriafol residues. To the extent that those birds do not reside exclusively and permanently within 

the area, exposure will be less and risk is presumably less. 

The chronic risks to birds from the formulated product itself are not estimated since bird 

reproduction studies with the formulated product, modeling, or extrapolated values are not 

available. 

Graph IV-1 below illustrates the number of applications needed to exceed the LOC for chronic 

risk to birds based on four applications of 0.11 lb ai/A at 7 days intervals with a default foliar halflife of 35 days. Based on the graph, the upper-bound Kenaga EECs exceed the LOC of 1 (NOAEC 

= 39.2 mg ai/kg diet) for birds foraging short grass after two applications; birds foraging 

broadleaves/small insects after three applications; and birds foraging tall grass after four

applications.

Based on the available information, this ecological risk assessment for non-passerine and passerine 

birds, including Federally-listed endangered and threatened species, suggests there is a potential 

for risk to adverse effects on survival, reproduction, and growth to birds, both non-passerine and 

passerine species, foraging on or near treated apple sites from exposure to the AI alone. For birds 

foraging on or near soybean fields, there is no indication of risk for adverse effects on survival, 

reproduction, and growth to birds from exposure to the active ingredient of flutriafol. 
87

Terrestrial Residues (upper bound estimates)

vs

Avian LOCs (as dietary concentrations)

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

90.00

100.00

0 4 8 12 16 20 24 28 32 36 40 44 48 51 55 59 63 67 71 75 79 83 87 91 95 99 103

Days

Concentration (mg ai/kg dietary item)

Short Grass Tall Grass Broadleaf plants/sm Insects Fruits/pods/seeds/lg insects Avian Chronic LOC

Graph IV-1. Number of applications required to exceed the LOC of 1 for adverse effects of growth and 

reproduction to birds. 
88

Acute Risk to Mammals

(1) Acute Risk of the AI Alone to Mammals

Based on the highest exposure scenario (apples) for the AI alone and upper bound EECs, the dosebased RQs of 0.1 – 0.4 exceed the acute restricted use and endangered species LOCs for 15 g, 35 g 

and 1000 g mammals where apples are grown. For both soybean uses (3 applications @ 0.06 lb 

ai/A with either 14-day or 21-day intervals), the acute restricted use and endangered LOCs are 

exceeded for 15 g and 35 g mammals feeding on short grass with residues of the AI alone. The 

dose-based RQs for all weight classes of mammals that consume fruits, pods, and large insects and 

granivores are <0.03 for all use scenarios and do not exceed the acute LOCs. Thus, these 

exceedances indicate that mammals may be at risk for adverse effects on survival from acute 

exposure to the AI alone as a result of the labeled uses of the fungicide.

The maximum use scenario for soybeans and apples in this baseline risk assessment assumes three 

and four applications, respectively, per season. Considering lower numbers of applications at 0.11 

lbs ai/A and 7-day reapplication intervals (apple), for 15 g and 35 g mammals feeding on short 

grass, there is a potential for risk if flutriafol is applied one or more times. For 15 g and 35 g 

mammals feeding on tall grass, broadleaf plants, and small insects and for 1000 g mammals

feeding on short grass, it requires two or more applications of the AI to exceed the LOC. It 

requires four or more applications to 1000 g mammals feeding on broadleaf forage and small 

insects. Considering lower numbers of applications at 0.06 lbs ai/A and either 14-day or 21-day

intervals (soybean), for 15 g and 35 g mammals feeding on short grass with residues of the AI 

alone, there is a potential for risk if flutriafol is applied two or more times to exceed the LOC. 

The dietary-based risks for the AI alone are not estimated since dietary mammal studies or 

extrapolated values are not available. 

(2) Acute Risk of its Formulated Product itself to Mammals

Acute RQs for mammals exposed to the formulated product itself are not quantitatively calculated. 

In order to compare the acute value of the product itself to mammal with an exposure value, the 

highest AgDRIFT EEC of 0.0036 mg form/L is selected from the soybean aerial use scenario. A 

comparison of the ecotoxicity value of the product itself (>2000 mg form/kg) with the highest

EEC, indicates a 556,000-fold difference between the AgDRIFT EEC and the concentration which 

produced a lethal effect on 50% of the mammalian species.

(3) Acute Risk Summary for Mammals Exposed to the AI alone and 

to its Formulated Product

Although there is an exceedance of the acute LOCs for the AI alone, the potential risk for adverse 

effects on survival is based on the assumption that mammals are feeding exclusively within 

agricultural areas where apples and soybeans are grown. The exceedance to 15 g, 35 g, and 1000 g 

mammals following flutriafol treatments is based on the assumption that mammals occupy, 

exclusively and permanently, the area of apple and soybean uses, and forage on feed items with 

residues of the AI alone. To the extent that those mammals do not reside exclusively and 
89

permanently within the area, exposure will be less and risk is presumably less. In addition, for the 

soybean scenarios with residues of the AI alone, the RQs from mean Kenaga EECs did not exceed 

LOCs. There are exceedances from mean Kenaga EECs with some mammals in the apple 

scenario, however. In addition, the formulated product of flutriafol, Flutriafol 125 g/L SC, is not 

toxic to mammals and the potential acute risk of the formulated product to mammals is likely to be 

minimal. 

Chronic Risk to Mammals

For spraying in apple sites and maximum predicted residue levels (upper bound EECs), the 

dietary-based risk quotients do not exceed LOC of 1 for chronic risk to mammals. However, based 

on dose-based RQs, there is an exceedance of the chronic risk LOC for 15g and 35g mammals 

consuming short grass, an exceedance for 15 g mammals consuming broadleaf plants and small 

insects in apple fields with residues of the AI alone. On the other hand, for soybean uses and dosebased RQs, there were no LOC exceedances for mammals foraging any of the assessed food items

with residues of the AI alone. Consequently, some mammal species are at risk for adverse effects 

on growth and reproduction from chronic exposure to the AI alone as a result of the applications in 

these areas where apples are grown. 

The maximum use scenario for apples assumes four applications per year. Considering lower 

numbers of applications, for 15 g and 35 g mammals feeding on short grass, there is a potential for 

chronic risk if flutriafol is applied to apples three or more times. 

Again, although there is an exceedance of the chronic LOC for the AI alone, the potential risk for 

adverse effects on growth and reproduction is based on the assumption that mammals are feeding 

exclusively within agricultural areas where apples are grown. The exceedance to those mammals 

following applications in apple sites is based on the assumption that mammals occupy, exclusively

and permanently, the area of proposed use, and forage on feed items with residues of the AI alone. 

To the extent that those mammals do not reside exclusively and permanently within the area, 

exposure will be less and risk is presumably less. 

The chronic risks to mammals from the formulated product itself are not estimated since mammal 

reproduction studies with the formulated product, modeling, or extrapolated values are not 

available. 

Based on the available information, this ecological risk assessment for mammals, including 

Federally-listed endangered and threatened species, suggests there is a potential for risk to adverse 

effects on survival, reproduction, and growth to mammals foraging on or near treated apple sites 

from exposure to the AI alone. For mammals foraging in or near treated soybean fields exposed to

3 applications of 0.06 lb ai/A with 14-day intervals, there is a potential risk for adverse effects on 

survival to mammals from exposure to the AI alone. On the other hand, there is no indication of 

risk for adverse effects on reproduction and growth to mammals foraging on or near treated 

soybean fields from 3 applications of the AI at 0.06 lb ai/A with 21-day intervals.
90

b. Terrestrial Plants 

In the conceptual model, spray drift, runoff and wind erosion of soil particles with resulting 

residues on upland and/or wetland foliage and soil are the most likely sources of flutriafol 

exposure to non-target terrestrial plants, including Federally-listed endangered and threatened 

species. Risks to terrestrial plants species are assessed based on modeled EECs and available 

toxicity data of the AI in its formulated product. As part of the baseline assessment, exposure 

concentrations of flutriafol to non-target terrestrial plants are modeled according to the labeled 

maximum application rates for the proposed uses. Terrestrial plant exposures were estimated 

using the TerrPlant 1.2.2 model. 

Risk to Non-listed Terrestrial Plants

Based on the toxicity data presented in Ecological Effects section, the results indicate that for 

soybean and apple uses, the non-listed plant LOC is not exceeded for monocots and dicots located 

adjacent to treated areas, inhabiting semi-aquatic areas, and as a result of a combination of runoff 

and/or spray drift.

Risk to Listed Terrestrial Plants

The listed plant LOC is not exceeded for monocots and dicots located adjacent to treated apple and 

soybean areas, inhabiting semi-aquatic areas, and as a result of a combination of runoff and/or

spray drift.

c. Terrestrial-phase Amphibians and Reptiles

EFED currently uses surrogate data (birds) for non-target terrestrial amphibians and reptiles. Bird 

risk data indicate that terrestrial-phase amphibians and reptiles may be at risk for adverse effects 

on survival, growth and reproduction from acute and chronic dietary exposures to the AI alone as a 

result of consuming contaminated short grass, tall grass, broadleaf forage, and small insects 

following spraying in apple sites. Also, the bird risk data indicates that terrestrial-phase 

amphibians and reptiles may be at risk for adverse effects on survival from acute dietary exposures 

to the AI alone as a result of consuming contaminated short grass following treatments in soybean 

fields. However, the resulting bird acute risk data for the soybean scenario indicates that when the 

reapplication interval is increased to 21 days from 14 days, the terrestrial-phase amphibians and 

reptiles are not anticipated to be at risk from flutriafol treatments via acute or chronic exposures. 

Since terrestrial-phase amphibians do not produce eggs in the exact manner as birds, the 

physiology of female amphibians that are developing eggs within their body are similar to female 

birds. Thus, the observed adverse effects on hatchability in avian reproduction studies with the AI

indicate terrestrial-phase amphibians may have hatchability difficulties from exposure to the 

contaminated food items with residues of the AI alone. 

d. Beneficial Insects

The available terrestrial insect toxicity data, based on tests with honeybees, suggest that the AI 
91

alone and its formulated product are practically non-toxic to bees on an acute contact basis. The

LD50 values range from >10.5 μg ai/bee to >155 μg ai/bee. Risk to beneficial insects in the direct 

treatment area exposed to the AI alone or its formulated product is expected to be minimal; 

consequently, precautionary labeling for honeybee protections is not required at this time. 

3. Review of Incident Data

FIFRA 6(a) (2) incident data add lines of evidence to risk predictions from the baseline assessment 

thus supporting the risk predictions with actual effects in the field. As expected for a new 

pesticide, no incidents of flutriafol damage are recorded in the Ecological Incident Information 

System (EIIS) as of August 2008.

4. Endocrine Effects 

EPA is required under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 

FQPA, to develop a screening program to determine whether certain substances (including all 

pesticide active and other ingredients) “may have an effect in humans that is similar to an effect 

produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” Following the recommendations of its Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), EPA determined that there were scientific bases for 

including, as part of the program, androgen and thyroid hormone systems, in addition to the 

estrogen hormone system. EPA also adopted EDSTAC’s recommendation that the Program 

include evaluations of potential effects in wildlife. When the appropriate screening and/or testing 

protocols being considered under the Agency’s Endocrine Disrupter Screening Program (EDSP) 

have been developed and vetted, flutriafol may be subjected to additional screening and/or testing 

to better characterize effects related to endocrine disruption.

5. Federally Threatened and Endangered (Listed) Species Concerns

a. Action Area

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

or indirectly by the Federal action and not merely the immediate area involved in the action. At 

the initial baseline, the risk assessment considers broadly described taxonomic groups and so 

conservatively assumes that listed species within those broad groups are co-located with the 

pesticide treatment area. This means that terrestrial plants and wildlife are assumed to be located 

on or adjacent to the treated site and aquatic animals and plants are assumed to be located in a 

surface water body adjacent to the treated site. The assessment also assumes that the listed species 

are located within an assumed area that has the relatively highest potential exposure to the 

pesticide, and that exposures are likely to decrease with distance from the treatment area. 

At this time EFED cannot make a “no effect” or “may effect” determination if the assumptions 

associated with the baseline action area result in RQs that are below or above the listed species 

LOCs since the Service(s) has not identified which listed species and critical habitat are potentially 

implicated. Furthermore, if RQs are below the listed species LOCs for a given taxonomic group, 

this may indicate a “no concern” for indirect effects upon listed species that depend upon the 

taxonomic group covered by the RQ as a resource. However, in situations where the baseline 
92

assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a 

potential for a "may affect" conclusion could exist and may be associated with direct effects on 

listed species belonging to that taxonomic group or may extend to indirect effects upon listed 

species that depend upon that taxonomic group as a resource. In such cases, additional information 

on the biology of listed species, the locations of these species, and the locations of use sites could 

be considered along with available information on the fate and transport properties of the pesticide 

to determine the extent to which baseline assumptions regarding an action area apply to a 

particular listed animal. These subsequent refinement steps could consider how this information 

would impact the action area for a particular listed animal and may potentially include areas of 

exposure that are downwind and downstream of the pesticide use site.

b. Taxonomic Groups Potentially at Risk

The baseline risk assessment for endangered species indicates that flutriafol TGAI exceeds the 

LOCs for the specified use scenario tabulated in Table IV-26 for apples and Table IV-27 for 

soybeans for the following taxonomic groups:

Table IV-26. Flutriafol TGAI Endangered Species LOC Exceedances for Apple Use

Levels of Concern

Taxa Acute Endangered 

Species

Chronic 

Risk

Listed 

Plants

Birds (including Reptiles and 

Terrestrial-phase Amphibians)

20 g Yes

100 g Yes Yes

1000 g No

Mammals 15 g Yes Yes

35 g Yes Yes

1000 g Yes Yes

Freshwater (including Aquaticphase Amphibians) and 

Estuarine/marine Fish

No No

Freshwater and Estuarine/marine 

Invertebrates No No

Terrestrial Monocots No

Terrestrial Dicots No

Aquatic Vascular Plants No

Aquatic Non-Vascular Plants No
93

Table IV-27. Flutriafol TGAI Endangered Species LOC Exceedances for Soybean Use

Levels of Concern

Taxa Acute Endangered 

Species

Chronic 

Risk

Listed 

Plants

Birds (including Reptiles and 

Terrestrial-phase Amphibians)

20 g Yes

100 g No No

1000 g No

Mammals 15 g Yes No

35 g Yes No

1000 g No No

Freshwater (including Aquaticphase Amphibians) and 

Estuarine/marine Fish

No No

Freshwater and Estuarine/marine 

Invertebrates No No

Terrestrial Monocots No

Terrestrial Dicots No

Aquatic Vascular Plants No

Aquatic Non-Vascular Plants No

The baseline risk assessment for endangered species indicates that the formulated product of 

flutriafol, Flutriafol 125 g/L SC, exceeds the LOCs for the specified use scenario tabulated below

(Table IV-28 for apples and soybeans) for the following taxonomic groups:

Table IV-28. Flutriafol 125 g/L SC Endangered Species LOC Exceedances for Apple and 

Soybean Uses

Levels of Concern

Taxa Acute Endangered Species Listed 

Plants

Birds (including Reptiles and 

Terrestrial-phase Amphibians)

20 g

100 g No data

1000 g

Mammals 15 g No

35 g No

1000 g No

Freshwater (including Aquaticphase Amphibians) and 

Estuarine/marine Fish

No

Freshwater Invertebrates No

Estuarine/marine Invertebrates No

Terrestrial Monocots No

Terrestrial Dicots No

Aquatic Vascular Plants No

Aquatic Non-Vascular Plants No

1. Discussion of Risk Quotients

The Agency’s LOC for endangered and threatened birds, mammals, terrestrial-phase amphibians, 

reptiles, and aquatic vascular plants are exceeded for the use of flutriafol as outlined in previous 

sections. Should estimated exposure levels occur in proximity to listed resources, the available 
94

baseline information may suggest a potential concern for direct effects on listed species within 

these taxonomic groups listed above associated with the currently supported uses of flutriafol.

2. Probit Dose Response Relationship

The Agency uses the probit dose-response relationship as a tool for providing additional 

information on the potential for acute direct effects to individual listed species and animals that 

may indirectly affect the listed species of concern (USEPA, 2004). As part of this evaluation, the 

acute RQ for listed species is presented in terms of the chance of an individual event (mortality or 

immobilization) should exposure at the EEC actually occur for a species with sensitivity to the 

active ingredient alone and to the fraction active ingredient in the product on par with the acute 

toxicity endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses 

the slope of the dose-response relationship available from the toxicity study used to establish the 

acute toxicity measures of effect for each taxonomic group that is relevant to this baseline 

assessment. The individual effects probability associated with the acute RQ is based on the mean 

estimate of the slope and an assumption of a probit dose-response relationship. In addition to a 

single effects probability estimate based on the mean, upper and lower estimates of the effects 

probability are also provided to account for variance in the slope, if available. Based on the 

available acute toxicity for flutriafol TGAI and it s formulated product, a summary of the probit 

dose-response analysis is provided in Table IV-29. In cases where dose-response curves are 

unavailable, event probabilities are calculated for the listed species LOC based on a default slope 

assumption of 4.5 with 95% confidence interval of 2 and 9 as per original Agency assumptions of 

typical slope cited in Urban and Cook (1986). 

Individual effect probabilities are calculated based on an Excel spreadsheet tool IECV1.1 

(Individual Effect Chance Model Version 1.1) developed by the U.S. EPA, OPP, Environmental 

Fate and Effects Division (June 22, 2004). The model allows for such calculations by entering the 

mean slope estimate (and the 95% confidence bounds for that estimate) as the slope parameter for 

the spreadsheet. The desired threshold for the probability of an individual effect is also derived 

based on the calculated acute RQ, if available.

For flutriafol, a probit dose response analysis was performed for toxicity studies with the TGAI 

and its formulated product for which slopes with 95% confidence intervals are available (i.e., 

TGAI studies with freshwater fish (sunfish), freshwater invertebrates (daphnid), estuarine/marine 

invertebrates (shrimp), bird oral (partridge), and bird dietary (duck) plus formulated product 

studies with freshwater fish (sunfish) and freshwater invertebrates (daphnid). No significant 

mortality was observed in acute toxicity studies with the TGAI for estuarine/marine fish 

(sheepshead), thus, the probit dose response analysis was not performed for this taxon. 

The probability of an individual effect was estimated at the acute endangered species LOC for 

aquatic and terrestrial animals (Table IV-29). Plants and oysters are not included in the probability

analysis because it is not possible to establish a relationship using continuous data. This analysis is 

presented in the following table.
95

Table IV-29. Probit Dose Response Relationship Analysis

Taxa Test 

Material

Acute Effect 

Slope (95% 

C.I.)

Chance of 

Individual 

Effect at Listed 

Species LOC 

(95% C.I.)

Chance of Individual 

Effect at Derived 

Acute RQ1(95% C.I.)

Comment

Freshwater Fish

Technical 

Grade

Mortality Slope 

= 4.04 (2 – 6.1)

1 in 1.36E+7

(1 in 216 to 1 in 

9.6E+14)

1 in 5.8E+33

(1 in 1.3E+9 to 1 in 

1.8E+75)

None

%AI of 

product

Mortality

Slope N/A = 4.5 

(2 – 9)

1 in 4.2E+8 

(1 in 216 to 1 in 

1.8E+31)

1 in 3.5E+10

(1 in 557 to 1 in 

6.4E+38)

Data insufficient to allow

for probit slope 

derivation; therefore, the 

default slope of 4.5 with 

lower and upper bounds 

of 2 – 9 was used.

Estuarine/marine 

Fish

Technical 

Grade

No significant 

mortality 

observed

Not calculated; 

no mortality 

observed

Not calculated; no 

mortality observed

Probit analysis not 

performed due to no 

significant mortality for 

estuarine/marine fish

Freshwater 

Invertebrates

Technical 

Grade

Immobilization 

Slope = 5.43 

(3.41-7.45)

1 in 1.2E+12

(1 in 2.2E+5 to 1 

in 6.2E+21

1 in 2.64E+71

(1 in 9.3E+28 to 1 in 

1.2E+133)

None

%AI of 

product

Immobilization

Slope N/A = 4.5 

(2 – 9)

1 in 4.2E+8

(1 in 216 to 1 in 

1.75E+31)

1 in 6.3E+9

(1 in 386 to 1 in 

7.5E+35)

Data insufficient to allow

for probit slope 

derivation; therefore, the 

default slope of 4.5 with 

lower and upper bounds 

of 2 – 9 was used.

Estuarine/marine 

Invertebrates –

shrimp

Technical 

Grade

Mortality Slope

N/A = 4.5 (2 - 9)

1 in 4.2E+8

(1 in 216 to 1 in 

1.75E+31)

1 in 2.1E+42

(1 in 1.8E+9 to 1 in 

1.0E+165)

The actual slope and its 

95% C.I. are greater than 

95%; therefore, the 

default slope of 4.5 with 

lower and upper bounds 

of 2 – 9 was used.

Bird oral dose Technical 

Grade 4.5 (2-9)

1 in 3E+5

(1 in 44 to 1 in 

9E+18)

1 in 57 (1.8%)

(1 in 6 to 1 in 8.1E+4)

The actual slope and its 

95% C.I. are greater than 

95%; therefore, the 

default slope of 4.5 with 

lower and upper bounds 

of 2 – 9 was used.

Bird dietary Technical 

Grade 4.5 (2-9)

1 in 3E+5

(1 in 44 to 1 in 

9E+18)

1 in 2.8E+11 (3.6E12%)

(1 in 862 to 1 in 

2.1E+42)

The actual slope and its 

95% C.I. are greater than 

95%; therefore, the 

default slope of 4.5 with 

lower and upper bounds 

of 2 – 9 was used.

As shown in Table IV-29, the probability for acute direct effects (mortality or immobilization) of 

the active ingredient to individual listed birds, freshwater fish and invertebrates, estuarine/marine 

fish and invertebrates at the listed species LOC range from 1 in 3E+5 (3.3E-4 %) for birds to 1 in 

1.2E+12 (8.3E-11 %) for freshwater invertebrates. However, at the highest derived RQ value for the 

uses of flutriafol, the chance of an individual effect for these taxa increase to approximately 1.8% 

for birds via the oral route, 3.6E-10 % for birds via the dietary route, 1.7E-32 % for freshwater fish, 
96

4.8E-41 % for estuarine/marine invertebrates, and 3.8E-70 % for freshwater invertebrates. 

3. Data Related to Under-represented Taxa

Effects data from analyzed sources (ECOTOX Database, PAN Database) or registrants-submitted 

studies with under-represented taxa are not available for this baseline risk assessment. 

4. Implications of Sublethal Effects 

Adverse effects observed in the reproduction toxicity studies with birds indicate significant effects 

of numerous reproduction endpoints at 97.5 mg ai/kg diet (NOAEC = 39.2 mg ai/kg diet). Effects 

observed in the 2-generation study with rats indicate a reduction in bodyweight gains, food 

consumption, and on effects on the liver in parents at 1000 mg ai/kg diet (NOAEC = 240 mg ai/kg 

diet (20.6 mg/kg bw/day male; and 21.9 mg/kg bw/day female)); decrease in live birth index and 

litter size and on effects on the liver of offspring at 1000 mg ai/kg diet (NOAEC = 240 mg ai/kg 

diet). 

c. Indirect Effects Analysis

Modeled exposures for the following taxonomic groups indicate LOC exceedances for birds 

consuming short grass, tall grass and broadleaf forage/small insects; consequently, there is a 

potential for indirect effects to listed species dependent upon birds for food, pollination or seed 

dispersal, or using burrows or cover requirements for shelter and breeding habitat. In addition, 

since birds serve as the surrogate for terrestrial-phase amphibians and reptiles, there is concern for 

potential indirect effects to listed species dependent on listed terrestrial-phase amphibians and 

reptiles. Also, the LOC is exceeded for 15 g and 35 g mammals; there is a concern for potential 

indirect effects to listed species dependent on listed mammals. 

d. Critical Habitat

In the evaluation of pesticide effects on designated critical habitat, consideration is given to the 

physical and biological features (constituent elements) of a critical habitat identified by the U.S 

Fish and Wildlife and National Marine Fisheries Services as essential to the conservation of a 

listed species and which may require special management considerations or protection. The 

evaluation of impacts for a baseline pesticide risk assessment focuses on the biological features 

that are constituent elements and is accomplished using the baseline taxonomic analysis (risk 

quotients, RQs) and listed species levels of concern (LOCs) that are used to evaluate direct and 

indirect effects to listed animals.

The baseline risk assessment has identified potential concerns for indirect effects on listed species

for those animals and plants dependant upon birds, mammals, terrestrial-phase amphibians, and 

reptiles. In light of the potential for indirect effects, the next step for EPA and the Service(s) is to 

identify which listed species and critical habitat are potentially implicated. Analytically, the 

identification of such species and critical habitat can occur in either of two ways. First, the 

agencies could determine whether the action area overlaps critical habitat or the occupied range of 

any listed species. If so, EPA would examine whether the pesticide's potential impacts on non-
97

endangered species would affect the listed species indirectly or directly affect a constituent 

element of the critical habitat. Alternatively, the agencies could determine which listed species 

depend on biological resources, or have constituent elements that fall into, the taxa that may be 

directly or indirectly impacted by the pesticide. Then EPA would determine whether use of the 

pesticide overlaps the critical habitat or the occupied range of those listed species. At present, the 

information reviewed by EPA does not permit use of either analytical approach to make a 

definitive identification of species that are potentially impacted indirectly or critical habitats that is 

potentially impacted directly by the use of the pesticide. EPA and the Service(s) are working 

together to conduct the necessary analysis.

This baseline risk assessment for critical habitat provides a listing of potential biological features 

that, if they are constituent elements of one or more critical habitats would be of potential concern. 

These correspond to the taxa identified above as being of potential concern for indirect effects and 

include the following: birds, mammals, reptiles, and terrestrial-phase amphibians. This list should 

serve as an initial step in problem formulation for further assessment of critical habitat impacts 

outlined above, should additional work be necessary.

e. Direct Effect Co-occurrence Analysis

Because the Endangered Species LOC for birds, mammals, reptiles, and terrestrial-phase 

amphibians is exceeded for the proposed uses of flutriafol on apples and the endangered species 

LOC for birds and mammals is exceeded for soybeans, LOCATES was run for all listed birds, 

mammals, reptiles, and terrestrial-phase amphibians to determine the potential for co-occurrence 

of listed animals located within areas of expected pesticide use. When baseline assessment 

information suggests that a listed species occurs in counties where a pesticide is used, there is a 

potential for a direct effect from flutriafol use, should exposure actually occur. The animal taxa 

that reside in those areas, and the basis for the designation, are in Appendices J and L. 

Additional analysis of listed animal locations, refinement of the action area associated with 

flutriafol regulatory decisions, and the biology of the potentially affected species would be needed 

before an effects determination can be made for any of the co-located species identified by this 

assessment.

LOCATES is used to preliminarily identify areas where listed animals could be located within the 

counties in USA where the proposed uses for flutriafol are labeled. Consequently, based on the 

information available at this step in the assessment process, it is presumed that all listed bird, 

mammal, terrestrial-phase amphibian, and reptile species are potentially directly affected from 

flutriafol uses for agricultural areas. Such potential concerns are limited by the true potential for 

exposures of critical resources to modeled flutriafol levels. LOCATES listed 153

endangered/threatened bird, mammal, terrestrial-phase amphibian, and reptile species located in 

areas where apples are grown. Eighty (80) endangered/threatened bird and mammal species are

listed in areas where soybeans grown nationwide. Consequently, based on the information 

available, it is presumed listed species reside in areas of expected pesticide use (Table IV-30).
98

Table IV-30 Number of Listed Species Located in Crop Areas in the United States of America.

Crop Affected Counties Affected States No. of Species

Apples 1,694 48 153

Soybeans 1,665 41 80

f. Indirect Effect Co-occurrence Analysis

The baseline risk quotients for birds, reptiles, mammals, aquatic vascular plants, and terrestrialphase amphibians exceed the LOC for endangered species. In accordance with established 

procedures, such findings suggest a potential concern for indirect effects to listed animal and plant 

species with both narrow (i.e., species that are obligates or have very specific habitat or feeding 

requirements) and general dependencies (i.e., cover type requirements) on plants or animals as a 

resource or important habitat component. LOCATES is used to preliminarily identify listed animal 

and plant species that are located within the counties in USA where flutriafol could be used on 

apples and soybeans. This analysis considered all animal and plant taxonomic groups (i.e., 

conifers/cycads, monocots, dicots, ferns, lichens, mammals, insects, fish, and invertebrates) that 

depend on those listed animal species; terrestrial and aquatic plants that require birds and 

mammals as pollinators or seed dispersers; species that require mammal or reptile burrows for 

shelter or breeding habitats; and aquatic animals and plants that require cover requirements. In 

addition, LOCATES is used to identify species that could be potentially indirectly affected by

flutriafol effects on listed species from apple and soybean uses in counties of USA. The animal 

and plant species that reside in those areas, and the basis for the designation, are in Appendices J 

and L and are summarized in Table IV-31, below. Such potential concerns are limited by the true 

potential for exposures of critical animal and plant species resources to modeled flutriafol levels 

and the relationship between ‘directly affected’ listed species and ‘indirectly affected’ listed 

species. Consequently, additional analysis of listed species locations, refinement of the action area 

associated with flutriafol regulatory decisions, and the biology of the potentially affected species 

would be needed before an effects determination can be made for any of the co-located species 

identified by this assessment for potential indirect effects.

Table IV-31. Listed Taxonomic Groups Potentially at Risk for Direct or Indirect Effects as a Result of 

Flutriafol Applications (Applications are for Terrestrial Outdoor Uses where Apples and Soybeans are grown 

Nationwide). 

Listed Taxon Direct 

Effects

Uses of Direct Effects 

Concern

Indirect 

Effects

Uses of Indirect Effects 

Concern

Terrestrial and SemiAquatic Plants – monocots No None Yes3,4 Apple and Soybean

Terrestrial and SemiAquatic Plants -- dicots No None Yes3,4 Apple and Soybean

Terrestrial Invertebrates No None Yes3,4 Apple and Soybean

Birds and Reptiles1 Yes Apple and Soybean6 Yes3,4 Apple and Soybean

Terrestrial-phase 

Amphibians1 Yes Apple and Soybean6 Yes3,4 Apple and Soybean
99

Mammals Yes Apple and Soybean5 Yes3,4 Apple and Soybean

Aquatic Vascular Plants No Apple Yes3,4 Apple and Soybean

Freshwater Fish and 

Aquatic-phase Amphibians2 No None None None

Freshwater Invertebrates No None None None

Estuarine/marine Fish No None None None

Estuarine/marine 

Invertebrates No None None None

Aquatic Nonvascular Plants No None Yes3,4 Apple and Soybean

1 Birds are used as surrogate species for terrestrial-phase amphibians and reptiles; therefore, potential direct and 

indirect effects to endangered avian, terrestrial-phase amphibians and reptilian species are considered equivalent.

2 Fish are used as a surrogate for aquatic phase amphibians; therefore, potential direct and indirect effects to 

endangered fish and aquatic-phase amphibian species are considered equivalent.

3 Potential indirect effects on a taxon attributable to direct effects on birds, terrestrial-phase amphibians and 

reptiles.

4 Potential indirect effects on a taxon attributable to direct effects on mammals.

5 Both soybean uses to control soybean rust and leaf spot, cercospora blight and leaf spot, brown spot, and powdery

mildew.

6 For control of leaf spot, cercospora blight and leaf spot, brown spot, and powdery mildew growing on soybeans 

only. 

C. Assumptions, Uncertainties, Strengths and Limitations of the Flutriafol

Assessment.

Maximum use scenario

This screening-level risk assessment relies on labeled statements of the maximum rate of flutriafol

applications, the maximum number of applications, and the shortest interval between applications. 

Together, these assumptions constitute a maximum use scenario and can overestimate risk. 

However, the maximum use scenario must be considered because it is a reflection of the allowable 

use of flutriafol. The frequency at which actual uses approach these maximums is dependent on the 

number and timing of applications, and market forces. In addition, rates of application less than the 

maximum rate are also considered.

Lack of data on degradates

There are several areas of uncertainty in the terrestrial and the aquatic species risk assessments that 

could potentially cause an underestimation of risk. First, this assessment accounts only for 

exposure of non-target species to the active ingredient alone, the AI in its formulated product, and 

formulated product itself, but not to its degradates. The risks presented in this assessment could be 

underestimated if degradates also exhibit toxicity under the conditions of use proposed on the 

label. The degradates of flutriafol were not reviewed in this assessment; however, 1,2,4-triazole is 

a common degradate of all conazole pesticides and its fate properties and toxicity will be 

addressed by the Agency in a separate assessment. 

Uncertainties with GENEEC 2 model

Extrapolating the risk conclusions from the standard pond scenario modeled by GENEEC2 may
100

either underestimate or overestimate the potential risks. Major uncertainties with the standard 

runoff scenario are associated with the physical construct of the watershed and representation of 

vulnerable aquatic environments for different geographic regions. The physicochemical properties 

(pH, redox conditions, etc.) of the standard farm pond are based on a Georgia farm pond. These 

properties are likely to be regionally specific because of local hydrogeological conditions. Any 

alteration in water quality parameters may impact the environmental behavior of the pesticide, 

depending upon the specific properties of a given chemical (for example, pH and dependant 

hydrolysis). The farm pond represents a well-mixed, static water body. Because the farm pond is a 

static water body (no flow through), it does not account for pesticide removal through flow 

through or accidental water releases. However, the lack of water flow in the farm pond provides an 

environmental condition for accumulation of persistent pesticides. The assumption of uniform 

mixing does not account for stratification due to thermoclines (e.g., seasonal stratification in deep 

water bodies). Additionally, the physical construct of the standard runoff scenario assumes a 

watershed:pond area ratio of 10 to 1. This ratio is recommended to maintain a sustainable pond in 

the Southeastern United States. The use of higher watershed:pond ratios (As recommended for 

sustainable ponds in drier regions of the United States) may lead to higher pesticide concentrations 

when compared to the standard watershed:pond ratio. Furthermore, long range atmospheric 

transport is beyond the scope of either GENEEC2 or AgDRIFT assessments, and has not been 

considered here. 

Location of wildlife species

For baseline terrestrial risk assessments for listed species, a generic bird or mammal is assumed to 

occupy either the treated field or adjacent areas receiving or ingesting pesticide at a rate 

commensurate with the treatment rate on the field. Model predictions suggest that this assumption 

leads to an overestimation of exposure to species that do not occupy the treated field. The actual 

habitat requirements of any particular terrestrial species are not considered, and it is assumed that 

species occupy, exclusively and permanently, the treatment area being modeled. This assumption 

leads to a maximum level of exposure in the risk characterization. To the extent that a species does 

not reside exclusively and permanently in treated areas, exposure will be less, and presumably less. 

Routes of exposure

Baseline risk assessments for granular applications of pesticides consider dietary exposure alone. 

Other routes of exposure, not considered in this assessment, are discussed below:

- Incidental soil ingestion exposure

The baseline risk assessment does not consider incidental soil ingestion. Available data suggests 

that up to 15% of the diet can consist of incidentally ingested soil depending upon species and 

feeding strategy (Beyer et al. 1994).

- Inhalation exposure

The baseline risk assessment does not consider inhalation exposure. Such exposure may occur 

through two potential sources: (1) vapor phase pesticide volatilizing from treated surfaces and (2) 
101

airborne particulate (soil, vegetative material, and pesticide dusts/crystals/flakes).

Theoretically, inhalation of pesticide active ingredient in the vapor phase may be another source of 

exposure for some pesticides under some exposure situations. However, considering its low vapor 

pressure value (4 x 10-7 mm Hg), it is unlikely that flutriafol will exist in the gaseous phase at any 

considerable amount to cause any adverse effects via inhalation. 

- Dermal exposure

The screening assessment does not consider dermal exposure, except as it is indirectly included in 

calculations of risk indices based on lethal doses per unit of pesticide treated area. Dermal 

exposure may occur through three potential sources: (1) direct application of flakes/crystals to 

terrestrial wildlife in the treated area, (2) incidental contact with contaminated vegetation, or (3) 

contact with contaminated water or soil. 

The available measured data related to wildlife dermal contact with pesticides are extremely

limited. The Agency is actively pursuing modeling techniques to account for dermal exposure via 

direct application of granules and by incidental contact with vegetation. 

Dietary Intake – The Differences between Laboratory and Field Conditions

The acute and chronic characterization of risk rely on comparisons of wildlife dietary residues with 

LC50 or NOAEC values expressed in concentrations of pesticides in laboratory feed. These 

comparisons assume that ingestion of food items with flutriafol residues in the field occurs at rates 

commensurate with those in the laboratory. Although the screening assessment process adjusts 

dry-weight estimates of food intake to reflect the increased mass in fresh weight wildlife food 

intake estimates, it does not allow for gross energy and assimilative efficiency differences between 

wildlife food items and laboratory feed.

On gross energy content alone, direct comparison of a laboratory dietary concentration- based 

effects threshold to a fresh-weight pesticide residue estimate would result in an underestimation of 

field exposure by food consumption by a factor of 1.25 – 2.5 for most food items. Only for seeds 

would the direct comparison of dietary threshold to residue estimate lead to an overestimate of 

exposure.

Differences in assimilative efficiency between laboratory and wild diets suggest that current 

screening assessment methods do not account for a potentially important aspect of food 

requirements. Depending upon species and dietary matrix, bird assimilation of wild diet energy

ranges from 23 – 80%, and mammal’s assimilation ranges from 41 - 85% (U.S. Environmental 

Protection Agency, 1993). If it is assumed that laboratory chow is formulated to maximize 

assimilative efficiency (e.g., a value of 85%), a potential for underestimation of exposure may

exist by assuming that consumption of food in the wild is comparable with consumption during 

laboratory testing. In the screening process, exposure may be underestimated because metabolic 

rates are not related to food consumption. 

Finally, the screening procedure does not account for situations where the feeding rate may be 
102

above or below requirements to meet free-living metabolic requirements. Gorging behavior is a 

possibility under some specific wildlife scenarios (e.g., bird migration) where the food intake rate 

may be greatly increased. Kirkwood (1983) has suggested that an upper-bound limit to this 

behavior might be the typical intake rate multiplied by a factor of 5.

Use of the most sensitive species tested

A small number of surrogate species are used in this baseline risk assessment. It is not possible to 

determine whether the species tested are more or less sensitive than species that may be exposed to 

flutriafol. In addition, it is assumed that fish are approximately as sensitive as aquatic-phase 

amphibians and that bird are approximately as sensitive as terrestrial-phase amphibians and 

reptiles. However, no data are available to support these conclusions.

Lack of field studies

Although not required, field studies would assist in determining the actual extent of potential 

indirect effects to plants that depends on mammals and birds as pollinators and to animals that

depends on reptile or mammal burrows for shelter and habitat.

Age class and sensitivity of effect thresholds

It is generally recognized that test organism age may have a significant impact on the observed 

sensitivity to a toxicant.

The screening risk assessment acute toxicity data for fish are collected on juvenile fish between 0.1 

and 5 grams. Aquatic invertebrate acute testing is performed on recommended immature age 

classes (e.g., first instar for daphnids, second instar for amphipods, stoneflies and mayflies, and 

third instar for midges). 

Acute dietary testing with birds is performed on juveniles, with mallard being 5-10 days old and 

bobwhite quail 10-14 days old.

Testing of juveniles may overestimate toxicity at older age classes for pesticidal active ingredients 

because younger age classes may not have the enzymatic systems associated with detoxifying 

xenobiotics. The baseline risk assessment has no current provisions for a generally applied method 

that accounts for this uncertainty. As far as the available toxicity data may provide ranges of 

sensitivity information with respect to age class, the risk assessment uses the most sensitive lifestage information as the conservative screening endpoint.

Acute and Chronic LOCs

The risk characterization section of this assessment includes an evaluation of the potential for 

individual effects at an exposure level equivalent to the LOC. This evaluation is based on the 

median lethal dose estimate and dose/response relationship established for the effects study

corresponding to each taxonomic group for which the LOCs are exceeded. The dose-response 

curve representing a given taxa is generated from one study using one species. It is likely that the 
103

resulting dose-response relationship does not represent the response of all species within a taxa. 

The risk estimates are based on acute and chronic effects in the laboratory; therefore, these risk 

estimates do not directly take into account uncertainties such as laboratory-to-field sensitivity

differences. These include uncertainty regarding the error introduced when extrapolating from 

laboratory to field effects at a given concentration. For example, mortality in the field could be 

greater in populations previously stressed by other pesticide exposures, temperature stress, habitat 

loss, predation, or competition for limited resources. Field mortality and reduction in growth and 

reproduction could be lower if the laboratory population were to represent an unusually sensitive 

species. 

REFERENCES

U.S. EPA. 2004a. Overview of the Ecological Risk Assessment Process in the Office of Pesticide 

Programs, U.S. Environmental Protection Agency. Endangered and Threatened Species Effects 

Determinations. Office of Prevention, Pesticides and Toxic Substances. Office of Pesticide 

Programs. Washington, D.C. January 23, 2004.

U.S. EPA. 2004b. Interim Guidance of the Evaluation Criteria for Ecological Toxicity Data in the 

Open Literature. Phases I and II. Procedures for Identifying, Selecting and Acquiring Toxicity

Data Published in the Open Literature for Use in Ecological Risk Assessments. Office of Pesticide 

Programs. July 16, 2004. 

U.S. EPA. 2000. Wildlife Exposure Factors Handbook. Office of Research and Development, 

Washington, D.C. EPA/600/R-93/187. December 1993.

Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of representative 

data as a basis for estimation of their magnitude in the environment. In F. Coulston and F. Korte, 

eds., Environmental Quality and Safety: Chemistry, Toxicology, and Technology, Georg Thieme 

Publ, Stuttgart, West Germany, pp. 9-28. Support Document # 14.

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of the EPA 

food-chain (Kenaga) nomogram, and instrument for estimating pesticide residues on plants. 

Environ. Tox. Chem. 13:1383-1391.
104

Appendix A. Environmental Fate Assessment and Data Summary

Flutriafol is stable to both hydrolysis and aquatic photolysis. Flutriafol is a fungicide that 

is expected to be is persistent and moderately mobile in the environment, with its major routes of 

dissipation through biotic degradation. Flutriafol biodegrades with half-lives of more than a year 

under aerobic and anaerobic, in both terrestrial and total-system aquatic environments. Laboratory

anaerobic aquatic data suggests more rapid degradation in aquatic environmental compartments (t1⁄2

= 6 weeks). Repeated applications may lead to accumulation of flutriafol residues in soil; as a 

result, flutriafol is expected to persist for years, and to build up with successive annual applications 

in both aerobic and anaerobic soil environments. Degradates of flutriafol were only reported in 

two studies, a soil photolysis study and an anaerobic aquatic metabolism study. They include 

1,2,4-triazole, triazole acetic acid, triazole alanine, 2,4’-difluorobenzophenone, and carbon 

dioxide. No major degradation products (i.e. > 10% of applied) were identified in any water or 

soil studies. 

As indicated by the adsorption/desorption coefficients, flutriafol is moderately mobile in 

the laboratory tested soils. This moderate potential for mobility, combined with the persistence 

demonstrated in laboratory metabolism half-lives greater than one year, indicate that under some 

environmental conditions, flutriafol does possess the potential to reach groundwater. Flutriafol is 

expected to reach surface water through drift, runoff, leaching, and/or erosion; drift and leaching 

are predicted to be the major contributors. Further, the vapor pressure of flutriafol indicates that 

volatility is not a major route of dissipation for this chemical in the environment. 

Field studies were inadequate to demonstrate a potential for flutriafol to significantly leach 

to ground water. While sufficient data to calculate ten half-life values have been submitted, all test 

plots were located at foreign testing sites. It was not determined if any of these sites were 

comparable to domestic test sites, none of the soil samples were analyzed for the formation of any 

degradation products, and storage stability data were often absent. However, flutriafol was 

detected in some test sites at the 30 cm sample depth, demonstrating that flutriafol has the ability

to slowly leach through the soil profile, and shows a potential to eventually reach ground water. 

Additionally, 6 non-guideline terrestrial field dissipation studies, most with applications over 

multiple years, indicate that flutriafol residues will remain undegraded, allowing residues to carryover from year to year under actual use conditions. When terrestrial field dissipation half-lives 

were calculated for test plots with multi-year applications (1 to 8 years), they were on the order of 

years. Reported carry-over ranged from between 9% and 48% calculated with data from 2 to >8 

years. Amounts of flutriafol residues reported in the aquatic and sediment phases of the test 

system at each sampling interval appear in Table A-2, below.

Due to the length of the studies, and the persistence of flutriafol, major degradates were not 

detected in either laboratory or field studies. Minor degradates of flutriafol, which were only

reported in two studies, a soil photolysis study and an anaerobic aquatic metabolism study include 

1,2,4-triazole, triazole acetic acid, triazole alanine, 2,4’-difluorobenzophenone, and carbon dioxide 

(CO2). With the exception of 1,2,4-triazole, none of the degradates above were considered a 

human health concern by the OPP Health Effects Division (HED). 1,2,4-Triazole was a minor 

degradate in the submitted studies, but is a common degradate to other fungicides. ,2,4-Triazole

has been determined to be a human health concern. 1,2,4-Triazole is a common degradate of all 
105

conazole pesticides. As a result, its fate properties and toxicity will be addressed by the Agency in 

a separate assessment. 

 

 

Figure A-1. Flutriafol Chemical Structure

Figure A-2. 1.2.4-Triazole Chemical Structure

N

N NH

N

N N C

H2

OH

F

F
106

Table A-1 Physical, Chemical and Environmental Fate Properties of Flutriafol

Physical and Chemical Properties

Chemical Name (common) Flutriafol

Chemical Name (CAS) α-(2-Fluorophenyl)-α-(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol

Chemical Abstract Number (CAS 

Number) 76674-21-0

Chemical Class Conazole

Molecular Weight (g/mol) 301.3

Aqueous Solubility (20 C) 130 mg/L

pKa Not reported. Neutral non-dissociating.

Vapor Pressure 4 x 10-7

Pa 

Henry’s Law Constant (20  C) 1.3 x 10-11 atm x m3 x mol-1

Octanol/water Partition Coefficient (log 

Kow at pH7) 2.29 

Environmental Fate Properties

Hydrolysis Half-life (pH 5, 7) t1/2 = stable

Aqueous Photolysis Half-Life t1/2 = stable

Photodegradation on Soil Half-Life t1/2 = 72.2 days (continuous irradiation)

Aerobic Soil Metabolism Half-Lives 

(total system) t1/2 = 120, 161, 257, 84, 98, 315, 3466, 347, and 239 weeks

Anaerobic Metabolism Half-Lives 

(total system)

t1/2 = < 1day in water

t1/2 = > 365 days in total system

Aerobic Aquatic Metabolism Half-Lives t1/2 = 42.6 days in water

t1/2 = > 100 days in total system

Soil-Water Partitioning Coefficients (Koc) 498, 205, 379, 230, 340, 428, 140 

Bioaccumulation in Fish Maximum BCF values were 6.8 for whole fish (day 3), 4.7 for muscle 

tissue (day 3), and 12.2 for viscera tissue (day 21)

Terrestrial Field Dissipation

(total system; non-linear) t1/2 = 1155, 3466, 2310, 990, 408, 1733, 105, 99, 696, and 261days 
107

Table A-2: Biotransformation of [14C]flutriafol, expressed as percentage of applied radioactivity (mean  s.d., n = 2).

Compound- Test System Sampling times (days posttreatment)

0 0.25 1 2 7 14 30 60 100

Flutriafol-United Kingdom stream 

water-sand sediment under aerobic

conditions MRID 47090419

Water 94.66 

0.53

84.11 

4.00

83.68 

0.66

77.32 

4.30

67.82 

1.58

52.98 

1.68

36.92 

3.74

21.72 

0.18

19.75 

0.15

Sediment 2.81 

0.47

6.36 

2.95

6.74 

1.12

14.11 

1.73

24.97 

1.16

34.31 

1.70

51.21 

5.53

66.23 

1.35

61.81 

1.74

Total 

System

97.47 

1.00

90.46 

1.05

90.42 

1.78

91.43 

2.56

92.79 

0.42

87.29 

0.02

88.13 

1.80

87.95 

1.17

81.56 

1.89

Compound- Test System Sampling times (days posttreatment)

0 0.25 1 2 7 14 30 60 100

Flutriafol- United Kingdom river 

water-silt loam sediment under 

aerobic conditions MRID 47090419

Water 88.18 

2.28

74.79 

4.65

77.73 

0.42

75.77 

1.75

61.58 

0.71

56.00 

5.20

34.52 

0.88

20.91 

1.95

12.86 

0.56

Sediment 10.64 

2.13

12.84 

1.25

11.37 

1.12

16.06 

2.47

27.09 

0.82

35.38 

4.03

55.68 

0.22

71.52 

2.95

75.50 

0.04

Total 

System

98.82 

0.16

87.62 

3.39

89.10 

1.56

91.83 

0.72

88.67 

0.12

91.38 

1.17

90.20 

0.67

92.42 

0.99

88.36 

0.52

Compound- Test System Sampling times (days posttreatment)

0 7 14 30 58 90 181 272 365

FlutriafolCalifornia pond water-sand clay

loam sediment under anaerobic

conditions

MRID 47090424

Water 8.4  

0.0

8.4  

0.7

4.4 

0.0

4.4 

0.2

4.7 

0.2

4.5 

0.0

3.3 

0.1

2.3 

0.4

4.6 

0.1

Sediment 88.4  

0.8

78.0 

0.4

86.6 

0.1

85.3 

0.5

83.5 

1.0

83.3 

1.5

79.3 

0.4

78.2 

2.3

83.1 

1.6

Total 

System

96.7  

0.8

86.4 

0.3

91.0 

0.1

89.7 

0.6

88.2 

1.2

87.8 

1.4

82.6 

0.3

80.5 

2.7

87.7 

1.7
108

Summary of Submitted Data

Hydrolysis 

MRID 47090416 The hydrolysis of [triazole14C]-labeled (RS)-2,4′-difluoro-α-(1H-1,2,4-

triazol-1-ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity >97.3%), at a nominal 

test concentration of 1.0 g a.i./mL, was studied at 25C in sterile aqueous buffered pH 5 (0.01M 

acetate), pH 7 (0.01M phosphate), and pH 9 (0.01M borate) solutions that were stored in the dark 

for up to 30 days. The test system consisted of sterilized 50-mL Erlenmeyer flasks containing 

treated buffer solution (30 mL). One flask was prepared for each pH level. Duplicate aliquots 

were collected from each flask at 0, 2, 8, 16, and 30 days post treatment. Volatiles were not 

collected. Samples were analyzed as collected, without manipulation or modification, for total 

[

14C]residues using LSC. [14C]Flutriafol and its transformation products were isolated and 

quantified using TLC and identified by retention time and comparison to unlabeled reference 

standards. 

During the study, the temperature of the buffer solutions were measured at ca. 24-hour intervals 

and were maintained at 25C. The pHs of the buffer solutions showed no appreciable variation 

throughout the study period (<0.1 pH units). The sterility of the test solutions was not 

determined. Overall recoveries were 98.2  1.5% of the applied radiation. There was no pattern 

of loss of material over time. [

14C]Flutriafol was stable in the pH 5, 7, and 9 solutions. No 

major or minor transformation products were isolated. This study is classified as acceptable. 

Aqueous Photolysis

MRID 47090417 The aqueous phototransformation of [triazolyl14C]- and [methine14C]-

labeled (RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol; 

radiopurity >96.1%), at 1.0 mg a.i./L, was studied at 25  1C in sterile aqueous buffered pH 7 

(0.01M phosphate) solution that was continuously irradiated using a UV-filtered xenon arc lamp 

(280-420 nm) for ca. 9 days. The intensity of the artificial light was equivalent to ca. 66 days of 

Florida sunshine. 

The test system consisted of sterilized glass, water-jacketed vessels containing treated bulk 

buffer solution covered with quartz lids and placed under the irradiation apparatus. Volatiles 

were trapped in 0.1M hydrochloric acid, two traps containing a mixture of ethanolamine, and 2-

ethoxyethanol. Duplicate aliquots of each irradiated buffer solution were collected for analysis 

at ca. 0, 8.8, and 9.6 days; dark controls were collected at 9 days. Samples were analyzed as 

collected, without manipulation or modification, by LSC and TLC. [14C]Flutriafol and its 

transformation products were isolated and quantified using TLC and identified by retention time 

and comparison to unlabeled reference standards. The sterility of the test solutions was not 

determined.

[Triazolyl14C]flutriafol and [methine14C]flutriafol were stable in the irradiated and dark control 

solutions. No major or minor transformation products were isolated. This study is classified as 

acceptable. 
109

MRID 47090418 The quantum yield of unlabeled (RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-

ylmethyl)benzhydryl alcohol (flutriafol; purity 98.8%), at a measured concentration of 25.72 mg 

a.i./L, was studied in pure water and irradiated continuously using a Xenon high stability short 

arc lamp for 5 hours at 20C. Nine irradiated samples and ten dark control samples were 

collected from the bulk solutions after 5 hours of irradiation. Identification of flutriafol was 

confirmed using HPLC. Flutriafol was identified by comparison to an external reference 

standard. Sterility checks and pH measurements were not performed. Mass balances were not 

determined.

The amount of light absorbed by flutriafol in units of mEinstein was determined using a 

QuantaCount. . The quantum yield of flutriafol was determined from the number of mmol of 

flutriafol photolyzed divided by the number of mEinstein of light it absorbed. After 5 hours of 

irradiation, an absorption of 1,501,800 “counts” of light were measured (equivalent to 7.06 x 10-4

mEinstein). The quantum yield was determined to be zero since there was no measurable 

photodegradation.

Based on HPLC analysis, the apparent loss of flutriafol due to photolysis was 0.4%, which is a 

decrease in concentration of 0.1 mg/L after 5 hours of irradiation. Based on these results, the 

study author concluded that the irradiation of flutriafol did not result in a significant decrease in 

the initial test concentration. The study author determined that because the quantum yield for 

photolysis of flutriafol in pure water is zero, degradation of flutriafol in the environment as a 

result of the direct absorption of sunlight will not be a significant process. This study is 

classified as supplemental. This was a quantum yield study, meant to supplement Subdivision N 

guidelines

Soil Photolysis

MRID 47090420 The phototransformation of [triazole14C] and [carbinol14C]-labeled (RS)-

2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity

98%) was studied on sandy loam soil (pH 7.25, organic matter 4.27%) from England under 

artificial light for 7 days or natural sunlight for 30 days. Flutriafol was applied to the soil at the 

proposed application rate of 94 g a.i./ha. 

The samples were irradiated using alternating “sunlight” ultraviolet and “black light” lamps for 7 

days. The intensity of the lamp and a comparison of the artificial light source to natural sunlight 

were not provided. Samples were also irradiated under natural sunlight in Berkshire, England 

from May 18 to June 17, 1982. The test system consisted of soil-covered glass plates that were 

air-dried and treated with [14C]flutriafol. The artificial light plates were placed into borosilicate 

glass test tubes that were continuously rotated on a merry-go-round accessory located within the 

photochemical reactor. Dark controls were not employed. 

The natural sunlight plates were placed into quartz glass conical flasks and placed outside in an 

unshaded location. Dark control plates were placed into quartz glass conical flasks wrapped in 
110

aluminum foil. Irradiated samples were collected at 0, 1, 4, and 7 days posttreatment for the 

artificial light plates and irradiated samples and dark controls were collected at 30 days 

posttreatment for the natural sunlight plates.

Soils were extracted twice with acetonitrile and twice with acetonitrile:water. The soil extracts 

and extracted soils were analyzed for total radioactivity using LSC. Flutriafol and its 

transformation products were isolated and quantified using TLC and identified by comparison to 

unlabeled reference standards of flutriafol and five possible transformation products.

Meaningful half-lives for flutriafol under artificial light conditions could not be determined 

because data were provided for only two sampling intervals; under natural sunlight conditions 

data were provided for only one sampling interval. This study is classified as supplemental. 

Meaningful half-lives could not be determined because of inadequate sampling intervals. The 

incubation temperature used during both experiments was not reported. A comparison of the 

artificial light source to natural sunlight was not reported, and the light/dark photoperiod was not 

reported. For the artificial light samples, the study was terminated after only 7 days of 

irradiation, at which time 70.4-76.5% of the applied [14C]flutriafol remained undegraded in the 

soil.

Results Synopsis

Label: Triazole.

Soil type: Sandy loam soil.

Source of irradiation: Alternating “sunlight” ultraviolet and “black light” lamps.

Half-life for Dark: Not applicable.

Half-life for Irradiated: Not determined.

Major and minor transformation products/dark: Not applicable.

Major transformation products/irradiated: None.

Minor transformation products/irradiated: 1H-Triazole (Compound IV).

Source of irradiation: Sunlight.

Half-life for Dark: Not determined.

Half-life for Irradiated: Not determined.

Major and minor transformation products/dark: Not reported.

Major transformation products/irradiated: None.

Minor transformation products/irradiated: 1H-Triazole (Compound IV).

Label: Carbinol.

Soil type: Sandy loam soil.

Source of irradiation: Alternating “sunlight” ultraviolet and “black light” lamps.

Half-life for Dark: Not applicable.

Half-life for Irradiated: Not determined.

Major and minor transformation products/dark: Not applicable.

Major transformation products/irradiated: None.

Minor transformation products/irradiated: Difluorobenzophenone (Compound VI).
111

Source of irradiation: Sunlight.

Half-life for Dark: Not determined.

Half-life for Irradiated: Not determined.

Major and minor transformation products/dark: Not reported.

Major transformation products/irradiated: None.

Minor transformation products/irradiated: Difluorobenzophenone (Compound VI).

MRID 47418401 The phototransformation of [14C-triazole]- and [14C-carbinol]-labeled (RS)-

2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity

99.3% and 98.7%), was studied on sandy clay loam soil (pH 7.0, organic carbon 1.3%) from 

California irradiated under artificial light for 312.5 hours (ca. 13 days). Flutriafol was applied to 

the soil at an actual application rate of 1.02-1.06 mg a.i./kg soil. 

The samples were continuously irradiated using a filtered xenon arc lamp (300-800 nm) for 

312.5 hours (ca. 13 days), which was equivalent to 31-32 days of natural summer sunlight at 

40°N. The test system consisted of thin air-dried soil layers treated with [14C]flutriafol in quartz 

dishes (50 mm diameter) equipped with a side arm. The dishes were submerged in a 

continuously circulating water bath and placed beneath the xenon lamp. Humidified air was 

drawn over the soil in the sample dishes and passed through a volatile trapping system. The dark 

controls were prepared in Pyrex dishes that were wrapped in aluminum foil and placed in an 

incubator in the dark. Duplicate irradiated samples and dark controls (triazole label only) were 

collected at 0, 26, 71.3, 144.5, 221.6, and 312.5 hours. 

Soil samples were extracted three to four times with acetonitrile:water. The combined soil 

extracts, volatile trapping solutions, and extracted soils following combustion were analyzed for 

total radioactivity using LSC. [

14C]Flutriafol and its transformation products were analyzed 

using reverse-phase HPLC and identified by comparison to unlabeled reference standards, with 

the identification confirmed using one- and two-dimensional TLC. Selected nonextractable 

residues were partitioned into humin, humic acid and fulvic acid fractions and analyzed by LSC. 

Since flutriafol in the dark controls were stable, the phototransformation half-life for 

[

14C]flutriafol is equivalent to the half-life observed in the irradiated samples. Based on firstorder linear regression analysis, the phototransformation half-life of flutriafol (combined 

labels) is 1,732.9 hours (72.2 days), based on the length of continuous light exposure used in the 

study. This half-life is of uncertain value since it is extrapolated beyond the duration of the study 

(ca. 13 days). For the irradiated samples of both labels, flutriafol decreased from an average of 

94.2-94.8% of the applied at time 0 to 78.8-81.2% at 312.5 hours (study termination). No 

transformation products were identified from either the irradiated soil or the dark controls; 

average maximums of residues were no greater than 5.8%. 

This study is classified as supplemental, because the study was terminated before the half-life of 

the test material was established. No significant deviations from good scientific practices were 

noted. However, no additional information would be obtained by repetition of this study. The 

study provides sufficient information to predict that flutriafol will be stable to photolysis on soil 

surfaces.
112

Results Synopsis

Soil type: Sandy clay loam soil.

Source of irradiation: Xenon arc lamp.

Triazole label

Half-life for Dark: Stable.

Half-life for Irradiated: 1,386 hours (r2= 0.7432).

No major transformation products were isolated in the irradiated samples.

Minor transformation products/ irradiated: CO2.

No major or minor transformation products were isolated in the dark control samples.

Carbinol label

Half-life for Dark: Not determined.

Half-life for Irradiated: 2,310.5 hours (r2= 0.5437).

No major transformation products were isolated in the irradiated samples.

Minor transformation products/ irradiated: CO2.

Dark controls were not used for the Carbinol label.

Aerobic Soil Metabolism 

MRID 47090421 The biotransformation of [triazole-3,5-

14C]-labeled (RS)-2,4′-difluoro-α-

(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol, radiochemical purity 99.9%) was 

studied in a sandy loam soil from North Dakota for 365 days under aerobic conditions in 

darkness at 25  1C and a soil moisture content of 75% of the water holding capacity. 

[

14C]Flutriafol was applied at a rate of 1.04 mg a.i./kg, which was reported to be equivalent to 1 

kg a.i./ha. The test system consisted amber glass bottles containing moistened treated soil that 

were connected to individual flow-through volatile trapping systems. Moistened, CO2-free air 

was continuously forced through a sample bottle, then through one vial of ethylene glycol to 

collect organic volatiles and two vials of 10% NaOH to collect CO2. Duplicate samples were 

collected at 0, 7, 14, 29, 61, 91, 180, 271 and 365 days posttreatment. The soil was extracted 

with acetonitrile:water, once by shaking and once by overnight Soxhlet extraction. Aliquots of 

the individual extracts were analyzed using LSC. The shaking and Soxhlet extracts were 

combined, and aliquots were analyzed using LSC and HPLC. Flutriafol and its transformation 

compounds were identified by comparison to unlabeled reference standards. Identification of 

flutriafol was confirmed using TLC. Aliquots of the volatile trapping solutions were analyzed 

using LSC. The extracted soil was analyzed using LSC following combustion. 

The temperature, aerobicity and moisture content of the soil were reportedly maintained 

throughout the experiment. Treated soil was shown to be viable throughout the study. There 

was no pattern of decline over time.

No major transformation products were isolated and no minor transformation products were 

identified. Based on the study results, flutriafol is relatively stable in aerobic soil, degrading to 

several very minor components, CO2 and bound residues over a period of decades. This study is 

classified as supplemental. 
113

Results Synopsis:

Test system used: Sandy loam soil.

Linear half-life: 6,932 days (r2= 0.4187).

Nonlinear half-life: 6,932 days (r2= 0.9996).

Observed DT50: >365 days.

Major transformation products: 

No major transformation products were isolated.

Minor transformation products: 

CO2.

MRID 47090422 The biotransformation of [triazole-3,5-

14C]- and [carbinol14C]-labeled 

(RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol, radiochemical 

purity 99%) was studied in six soils all from the United Kingdom.

 a sandy clay loam soil (18 Acres, pH 6.8, organic matter 4.7-4.9%); 

 a coarse sandy loam/loamy coarse sand soil (Frensham, pH 5.7-5.8, organic matter 1.8-

2.3%); 

 a sandy clay loam soil (Flexford, pH 5.6, organic matter 4.4%); 

 a sandy loam soil (Horsley, pH 6.5, organic matter 2.7%); 

 a clay soil (Boxford, pH 7.7, organic matter 4.3%) and 

 a sandy clay loam soil (Chalgrove, pH 6.4, organic matter 3.7%) 

Multiple experiments were conducted. It was not stated whether any guidelines were used to 

design the study protocol. The submitter did not know if the study was conducted according to 

any GLP standards. 

In one experiment, the 18 Acres and Frensham soils were treated with [triazole-3,5-

14C]flutriafol 

at 96 g a.i./ha and incubated for 36 weeks under aerobic conditions in darkness at 20  1C and a 

soil moisture content of 40% of the water holding capacity. The test system consisted of glass 

pots containing moistened treated soil. Like samples were placed inside a glass cylinder and 

connected to a volatile trapping system. Moistened, CO2-free air was continuously drawn 

through 0.05M H2SO4, 2-methoxyethanol, and ethanolamine solutions. 

In a companion experiment, the Flexford, Horsley, Boxford, and Chalgrove soils were treated 

with [triazole-3,5-

14C]flutriafol at 84 g a.i./ha and incubated for 18 weeks as described. Samples 

of the 18 Acres and Frensham soils were treated with [carbinol14C]flutriafol at 95 g a.i./ha and 

incubated as described. The volatile trapping system consisted only of the ethanolamine 

solutions. 

Single pots of each soil were collected at 0, 3, 9, and 18 weeks posttreatment, with the 

exceptions that the 18 Acres and Frensham soils were also collected at 36 weeks. Volatiles were 

collected at each sampling interval. The time 0 soil samples were extracted twice by refluxing 
114

with acetonitrile:water for 1 and then 2 hours. Samples collected after time 0 were Soxhletextracted twice with acetonitrile:water for 18 hours/extraction. The soil extracts and volatile 

trapping solutions were analyzed for total radioactivity using LSC. The soil extracts were 

analyzed by one-dimensional TLC. Flutriafol was identified by comparison to an unlabeled 

reference standard. The extracted soil was analyzed using LSC following combustion. For the 

flooded soil, the water layer was removed prior to soil extraction and analyzed using LSC and 

TLC; the soil was analyzed as described. Recoveries were variable, but there was no pattern of 

decline over time in any soil. In all six soils, flutriafol was relatively stable under the conditions 

of the study. Volatile [14C]organics were reported as not significant.

Additional experiments in which the temperature, moisture content, aerobicity or application rate 

were varied were conducted using 18 Acres soil. In all experiments, [14C]flutriafol was stable to 

relatively stable. This study is classified as supplemental. Except for CO2, no minor 

transformation products were identified. Additionally, it could not be determined if the British 

soils used in this study are comparable to soils found in a typical flutriafol use area in the United 

States. 

Results Synopsis:

Test system used: 18 Acres sandy clay loam soil (triazole plus carbinol labels).

Linear half-life: 120 weeks (r2= 0.5273).

Nonlinear half-life: 116 weeks (r2= 0.9962).

Observed DT50: >36 weeks.

Test system used: Frensham coarse sandy loam/loamy coarse sand soil (triazole plus 

carbinol labels).

Linear half-life: 161 weeks (r2= 0.5036).

Nonlinear half-life: 158 weeks (r2= 0.9978).

Observed DT50: >36 weeks.

Test system used: Flexford sandy clay loam soil.

Linear half-life: 257 weeks (r2= 0.2306).

Nonlinear half-life: 257 weeks (r2= 0.9988).

Observed DT50: >18 weeks.

Test system used: Horsley sandy loam soil.

Linear half-life: 84 weeks (r2= 0.8546).

Nonlinear half-life: 86 weeks (r2= 0.9994).

Observed DT50: >18 weeks.

Test system used: Boxford clay soil.

Linear half-life: 98 weeks (r2= 0.8702).

Nonlinear half-life: 98 weeks (r2= 0.9996).

Observed DT50: >18 weeks.

Test system used: Chalgrove sandy clay loam soil.
115

Linear half-life: 315 weeks (r2= 0.1015).

Nonlinear half-life: 301 weeks (r2= 0.9979).

Observed DT50: >18 weeks.

All soils:

Major transformation products: 

No major transformation products were isolated.

Minor transformation products: 

CO2.

MRID 47090423 The biotransformation of nonradiolabeled (RS)-2,4′-difluoro-α-(1H-1,2,4-

triazol-1-ylmethyl)benzhydryl alcohol (flutriafol, purity not reported) was studied in three 

European standard soils:

 Speyer 2.2 sand (pH 6.2, organic matter 3.6%) from Germany,

 Speyer 2.3 sand (pH 7.5, organic matter 1.5%) from Germany and 

 Warfield loamy sand soil (pH 5.7, organic matter 3.5%) from the United Kingdom, 

for 52 weeks under aerobic conditions in darkness at 20C and a soil moisture content of 40% of 

the water holding capacity. [14C]Flutriafol was applied at a rate of 1 mg a.i./kg, equivalent to a 

field rate of ca. 1 kg a.i./ha. The test system consisted conical flasks containing moist treated 

soil that were stoppered with cotton wool. Volatiles were not collected. Duplicate flasks were 

collected at 0, 2, 4, 6, 8, 16, 32 and 52 weeks posttreatment. The soil was extracted by refluxing 

with acetonitrile:pH 9 water. The soil extracts were partitioned with ethyl acetate and purified 

by adsorption chromatography, then analyzed for flutriafol using gas-liquid chromatography 

with nitrogen selective detection. The extracted soil was not analyzed. The temperature, soil 

aerobicity and soil moisture content were reportedly maintained throughout the experiment. The 

samples were analyzed only for flutriafol. A material balance could not be determined. 

Flutriafol was relatively stable under the conditions of the study. This study is classified as 

supplemental. Insufficient details about the study methods and materials were provided to allow 

a critical evaluation of the experiment. Samples were analyzed only for flutriafol. 

Transformation products and other residues were not quantified, and there was no material 

balance.

Results Synopsis:

Test system used: Speyer 2.2 sand soil from Germany.

Linear half-life: 3,466 weeks (66.5 years; r2= 0.0197).

Nonlinear half-life: Stable.

Observed DT50: >52 weeks.

Test system used: Speyer 2.3 sand soil from Germany.

Linear half-life: 347 weeks (6.7 years; r2= 0.5134).

Nonlinear half-life: 433 weeks (8.3 years; r2= 0.9992).
116

Observed DT50: >52 weeks.

Test system used: Warfield loamy sand soil from the United Kingdom.

Linear half-life: 239 weeks (4.6 years; r2= 0.9200).

Nonlinear half-life: 239 weeks (4.6 years; r2= 0.9998).

Observed DT50: >52 weeks.

All soils:

Major and minor transformation products were not determined.

Anaerobic Soil Metabolism

MRID 47090424 The biotransformation of [triazole-3,5-U14C]-labeled (RS)-2,4′-difluoroα-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity 99.9%) was 

studied in pond water-sandy clay loam sediment systems from California for 365 days under 

anaerobic conditions in darkness at 25  1C. Based on the water volume, [14C]flutriafol was 

applied at a rate of 0.75 mg a.i./L. The sediment:water ratio was ca. 1:1.4. For the time 0 

systems, the test apparatus consisted of sealed, 250-mL amber bottles. For all other intervals, the 

test apparatus consisted of 250-mL two-chambered biometer flasks with 10% NaOH in the sidechamber to trap CO2 and a polyurethane foam plug in the connecting side-arm to trap organic 

volatiles. To generate anaerobic conditions, the water-sediment systems were pre-incubated in 

the sealed flasks for >14 days prior to treatment and the test solution applied under nitrogen 

atmosphere. Following treatment, duplicate flasks were collected after 0, 7, 14, 30, 58, 90, 181, 

272 and 365 days of incubation. Water layers were separated from sediment by centrifugation, 

decanted, filtered and analyzed directly. Sediment samples were extracted once with 

acetonitrile:water via shaking, followed by an overnight Soxhlet extraction using the same 

solvent. Resulting extracts were combined, filtered and concentrated under nitrogen. Water 

layers, sediment extracts, extracted sediment and trapping materials were analyzed for total 

radioactivity using LSC. Water layer and sediment extract samples were analyzed for flutriafol 

and its transformation products via reverse-phase HPLC. In addition to parent flutriafol, 

reference standards of possible transformation products 1,2,4-triazole-1-alanine, 1,2,4-triazole-1-

acetic acid and 1,2,4-triazole were available for identification purposes. Identification of parent 

[

14C]flutriafol was confirmed via one-dimensional, normal-phase TLC against reference 

standard.

The test conditions presented in the study appear to have been maintained throughout the 365-

day incubation. Conditions in the treated systems were strongly reducing to moderately reducing 

with average redox potentials of -88  86 mV at the water-sediment interface; dissolved oxygen 

and pH levels averaged 0.79  0.71 mg/L and 8.15  0.62, respectively.

Following application of [14C]flutriafol to the water layer, [14C]residues rapidly partitioned from 

the water layer to the sediment with only 8.4% of the applied detected in the water layer at time 

0; mean distribution ratios (water:sediment) were 1:9-11 at 0-7 days and 1:14 thereafter. 

Formation of 14CO2 and volatile [14C]organic compounds were negligible at any interval.
117

Flutriafol was relatively stable in the total system, with dissipation occurring though rapid 

translocation from the aqueous phase to the sediment and only minor formation of several 

nonvolatile products, bound sediment residues, CO2 and volatile organic compounds. Calculated

half-lives were not determined. No major transformation products were detected, and only trace 

amounts (0.5% of applied) of three minor products were identified in the water layer. This 

study is classified as acceptable. 

Results Synopsis:

Test system used: Pond water-sandy clay loam sediment from California.

Linear half-life in water: ND (not determined).

Linear half-life in sediment: ND.

Linear half-life in the total system: ND.

Non-linear half-life in water: ND.

Non-linear half-life in sediment: ND.

Non-linear half-life in total system: ND.

Observed DT50 in water: <1 day.

Observed DT50 in sediment: >365 days.

Observed DT50 in total system: >365 days.

Major transformation products:

No major transformation products were isolated.

Minor transformation products:

1,2,4-Triazole-1-alanine (maximum 0.5% of applied in water layer).

1,2,4-Triazole-1-acetic acid (maximum 0.3% in water layer).

1,2,4-Triazole (maximum 0.1% in water layer).

CO2 (maximum 0.7% of applied).

Volatile organics (maximum 0.1% of applied).

Aerobic Aquatic Metabolism

MRID 47090419 The biotransformation of [triazole-3,5-

14C]-labeled (RS)-2,4′-difluoro-α-

(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity 99.5%) was 

studied in stream water-sand sediment and river water-silt loam sediment systems from the 

United Kingdom for 100 days under aerobic conditions in darkness at 20  2C. Based on the 

theoretical water volume, [14C]flutriafol was applied at a rate of ca. 0.43 mg a.i./L. The test 

apparatus consisted of cylindrical, glass vessels connected to a continuous flow-through system 

with traps for the collection of CO2 and volatile organics. Sediment and water were preincubated 37 days, then, following treatment, duplicate vessels per system type were collected 

after 0, 0.25, 1, 2, 7, 14, 30, 60 and 100 days of incubation. Water layers were drawn off via 

pipette and concentrated by rotary evaporation for TLC analysis. Sediment samples were 

Soxhlet-extracted twice with acetonitrile, followed by acetonitrile:water; resulting extracts were 
118

combined and concentrated via rotary evaporation for TLC analysis. Water layers, sediment 

extracts, extracted sediment, trapping solutions and incubation vessel rinses were analyzed for 

total radioactivity using LSC. Water layer and sediment extract samples were analyzed for 

flutriafol and its transformation products via normal-phase, one-dimensional TLC using two 

solvent systems. Only one reference standard, flutriafol, was used for identification purposes. 

The test conditions were moderately reducing to strongly oxidizing in the water layers and 

primarily reducing to moderately reducing in the sediments with mean redox potentials of +306 

 102 mV and +23  75 mV. Dissolved oxygen and pH in the water layers averaged 69  20% 

and 7.71  0.33.

There were no significant losses nor consistent patterns of decline in recoveries of applied 

radiolabeled material during the course of the study. Overall partitioning of [14C]residues 

between the water layers and sediments was similar for the two systems. Following application 

of [14C]flutriafol to the water layer, [14C]residues partitioned from the water layer to the sand. 

Formation of 14CO2 and volatile [14C]organic compounds were negligible at any interval.

Flutriafol gradually translocated from the water layers to the sediments during the incubation, but 

overall dissipation from the total systems was very slow. For both sediments and total systems, 

flutriafol observed DT50 values were >100 days. Consequently, calculated half-lives were not 

determined.

No major nonvolatile transformation products were detected, and no minor products were 

identified. Flutriafol slowly dissipated in the total system, with primary dissipation occurring 

though gradual translocation from the aqueous phase to the sediment, and only minor formation 

of several nonvolatile products, bound sediment residues, CO2 and volatile organic compounds. 

This study is classified as supplemental. No attempt was made to identify potentially toxic 

minor degradation products of flutriafol. 

Results Synopsis:

Test system used: Stream water-sand sediment from the United Kingdom.

Linear half-life in water: 42.6 days (r2= 0.8891).

Linear half-life in sediment: ND (not determined).

Linear half-life in the total system: ND.

Non-linear half-life in water: 27.9 days (r2= 0.9374).

Non-linear half-life in sediment: ND.

Non-linear half-life in total system: ND.

Observed DT50 in water: ca. 20 days.

Observed DT50 in sediment: >100 days.

Observed DT50 in total system: >100 days.
119

Major transformation products:

No major transformation products were isolated.

Minor transformation products:

CO2 (maximum 0.56% of applied).

Volatile organics (maximum 0.02% of applied).

Test system used: River water-silt loam sediment from the United Kingdom.

Linear half-life in water: 36.3 days (r2= 0.9610).

Linear half-life in sediment: ND.

Linear half-life in the total system: ND.

Non-linear half-life in water: 28.4 days (r2= 0.9592).

Non-linear half-life in sediment: ND.

Non-linear half-life in total system: ND.

Observed DT50 in water: ca. 18 days.

Observed DT50 in sediment: >100 days.

Observed DT50 in total system: >100 days.

Major transformation products:

No major transformation products were isolated.

Minor transformation products:

CO2 (maximum 0.15% of applied).

Volatile organics (maximum 0.01% of applied).

Adsorption/Desorption 

MRID 47090425 The adsorption/desorption characteristics of [triazole14C]-labeled (RS)-

2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol) were studied in a 

sandy loam soil and a clay loam soil, each from North Dakota, in a batch equilibrium 

experiment. The adsorption phase of the study was carried out by equilibrating soil with 

[

14C]flutriafol at nominal test concentrations of 0.25, 2.5, 4.5, 11.5, and 24.5 mg a.i./kg soil, in 

the dark at 25C for 24 hours. The equilibrating solution used was 0.01M CaCl2 solution with a 

soil solution ratio of 1:5 for all soils. The desorption phase of the study was carried out by 

replacing the adsorption solution with an equivalent volume of 0.01M CaCl2 solution and 

equilibrating in the dark at 25C for 24 hours. A single desorption step was performed for each 

test soil.

The supernatant solutions after adsorption and desorption were separated by centrifugation, and 

analyzed for total radioactivity using LSC. Following the desorption phase, high-dose soils were 

extracted twice with acetonitrile:water, and analyzed for total radioactivity using LSC. The 

radioactivity in the soil residue after desorption was determined by combustion. Aliquots of the 

high-dose adsorption and desorption supernatants and soil extracts were analyzed for 

[

14C]flutriafol using HPLC.
120

The experimental temperature employed during the study was reported to be maintained at 25C. 

This study is classified as supplemental. The study was conducted using only two soil types. 

However, when the mobility values reported in this study are combined with the values from the 

other submitted mobility study, MRID Number 47090426, the mobility data requirement for 

flutriafol is satisfied. 

Results Synopsis:

Soil type: Sandy loam.

Amount adsorbed: 36.3-63.0% of the applied.

Adsorption Kd: 3.7

Adsorption Koc: 264

Freundlich adsorption Kd: 3.2

Freundlich adsorption Koc: 230

Amount desorbed: 30.6-47.5% of the adsorbed.

Desorption Kd: Not reported.

Desorption Koc: Not reported.

Freundlich desorption Kd: 3.9

Freundlich desorption Koc: 279

Soil type: Clay loam.

Amount adsorbed: 75.1-101.6% of the applied.

Adsorption Kd: 13.6

Adsorption Koc: 340

Freundlich adsorption Kd: 11.1

Freundlich adsorption Koc: 278

Amount desorbed: 14.9-29.8% of the adsorbed.

Desorption Kd: Not reported.

Desorption Koc: Not reported.

Freundlich desorption Kd: 14.5

Freundlich desorption Koc: 361

MRID 47090426 The adsorption/desorption characteristics of [triazole14C]-labeled (RS)-

2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol) were studied in a 

loamy sand soil and a clay loam soil, each from France, in a batch equilibrium experiment. The 

adsorption phase of the study was carried out by equilibrating air-dried soil with [

14C]flutriafol at 

nominal test concentrations of 0.095, 0.49, 0.975, 4.9, and 9.7 mg a.i./kg soil, in the dark at 20 

2C for 24 hours. The equilibrating solution used was 0.01M CaCl2 solution with a soil solution 

ratio of 1:5 for all soils. The desorption phase of the study was carried out by replacing the 

adsorption solution with an equivalent volume of 0.01M CaCl2 solution and equilibrating in the 

dark at 20  2 for 48 hours. A single desorption step was performed for each test soil.

The supernatant solutions after adsorption and desorption were separated by centrifugation, and 

were analyzed for total radioactivity using LSC. Following the desorption phase, high-dose soils 

were extracted three times with acetonitrile:water, and analyzed for total radioactivity using 
121

LSC. The radioactivity in the soil residue after desorption and extraction was determined by

combustion. Aliquots of the high-dose adsorption and desorption supernatants and soil extracts 

were analyzed for [14C]flutriafol using HPLC. This study is classified as supplemental. It could 

not be determined if the foreign test soils were comparable to soils found in typical use areas in 

the United States. Mass balances were determined for high-dose soils only. The study was 

conducted using only two soil types. However, when the mobility values reported in this study

are combined with the values form the other submitted mobility study, MRID Number 

47090425, the mobility data requirements for flutriafol are satisfied. 

Results Synopsis:

Soil type: Loamy sand.

Amount adsorbed: 66.3-71.6% of the applied.

Adsorption Kd: 10.6

Adsorption Koc: 428

Freundlich adsorption Kd: 9.8

Freundlich adsorption Koc: 395

Amount desorbed: 23.3% of the adsorbed (high-dose only).

Desorption Kd: Not reported.

Desorption Koc: Not reported.

Freundlich desorption Kd: 13.7

Freundlich desorption Koc: 553

Soil type: Clay loam.

Amount adsorbed: 53.4-61.1% of the applied.

Adsorption Kd: 6.5

Adsorption Koc: 140

Freundlich adsorption Kd: 5.8

Freundlich adsorption Koc: 123

Amount desorbed: 33.5% of the adsorbed. (high-dose only).

Desorption Kd: Not reported.

Desorption Koc: Not reported.

Freundlich desorption Kd: 7.3

Freundlich desorption Koc: 156

MRID 47090427 The adsorption/desorption characteristics of [triazole14C]-labeled (RS)-

2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol) were studied in a 

loamy sand soil and a loam soil, each from England; and a silt loam soil from France, in a batch 

equilibrium experiment. The adsorption phase of the study was carried out by equilibrating airdried soil with [

14C]flutriafol at nominal test concentrations of 0.25, 0.5, 2, 5, and 10 mg a.i./kg 

soil, at 20  2C for 24 hours. The equilibrating solution used was 0.01M CaCl2 solution with a 

soil solution ratio of 1:10 for all soils. The desorption phase of the study was carried out by 

replacing the adsorption solution with an equivalent volume of 0.01M CaCl2 solution and 

equilibrating at 20  2 for 24 hours. Three desorption steps were performed for each test soil.
122

The supernatant solutions after adsorption and each desorption step were separated by 

centrifugation, and were analyzed for total radioactivity using LSC. Following the third 

desorption step, high-dose Bayonvillers silt loam soils were extracted three times with acetone, 

and analyzed for total radioactivity using LSC. The radioactivity in the soil residue after 

extraction was determined by combustion. Aliquots of the high-dose Bayonvillers silt loam 

desorption supernatants and soil extracts were analyzed for [14C]flutriafol using TLC.

The experimental temperature employed during the study was reported to be maintained at 20 

2C. [

14C]Flutriafol was stable in high-dose Bayonvillers silt loam desorption supernatants and 

soil extracts following the third desorption step, comprising 96.5% of the total radioactivity in 

the samples. Mass balances for soils at the end of the adsorption phase were not reported. This 

study is classified as supplemental. The study was conducted using only three soil types. It 

could not be determined if the foreign test soils were comparable to soils found in typical use 

areas in the United States. Material balances were not provided for all test soil/test concentration 

combinations.

Results Synopsis:

Soil type: Lillyfield loamy sand.

Amount adsorbed: 11.7-18.8% of the applied.

Adsorption Kd: 2.0

Adsorption Koc: 498

Freundlich adsorption Kd: 1.3

Freundlich adsorption Koc: 295

Amount desorbed: Not reported.

Desorption Kd: 4.7

Desorption Koc: 1048

Freundlich desorption Kd: Not reported.

Freundlich desorption Koc: Not reported.

Soil type: Bayonvillers silt loam.

Amount adsorbed: 14.8-20.4% of the applied.

Adsorption Kd: 2.5

Adsorption Koc: 205

Freundlich adsorption Kd: 1.9

Freundlich adsorption Koc: 157

Amount desorbed: 90.9% of the adsorbed. (high-dose only).

Desorption Kd: 4.2

Desorption Koc: 353

Freundlich desorption Kd: Not reported.

Freundlich desorption Koc: Not reported.

Soil type: Hyde Farm loam.

Amount adsorbed: 35.7-44.0% of the applied.

Adsorption Kd: 7.2

Adsorption Koc: 379
123

Freundlich adsorption Kd: 5.7

Freundlich adsorption Koc: 304

Amount desorbed: Not reported.

Desorption Kd: 10.9

Desorption Koc: 588

Freundlich desorption Kd: Not reported.

Freundlich desorption Koc: Not reported.

MRID 47090428 The adsorption partition coefficients of flutriafol were determined for 16 

European soils: four sandy loam soils, four sandy clay loam soils, three clay soils, two organic 

clay soils, and a loamy sand soil, each from the United Kingdom, and a clay loam and a silt

loam, each from Germany. For each test soil, control and treated soil samples were collected 

from a series of trials in which flutriafol was applied at 0.19-0.25 kg a.i./ha/year annually for 9 

years or at 0, 2, and 4 kg a.i./ha in a single dose at 3 years prior to sampling. The study was 

submitted under US EPA OPP Guideline 163-1. However, the guidance used to design the study 

protocol was not identified. This study was designed to evaluate the effect of time on the 

adsorption properties of flutriafol in soil. As such, the study was not designed as a typical batch 

equilibrium or column leaching study. 

The test soils were dried and sieved prior to use. For the soils from the treated plots, duplicate 

aliquots were added to Teflon tubes with sealing caps. Aliquots of 0.01M CaCl2 solution were 

added and the samples were thoroughly shaken and continuously mixed on an end-over-end 

shaker at 20  1C. For the soils from the untreated plots, duplicate aliquots were preequilibrated with 0.01M CaCl2 solution in Teflon tubes, then fortified with flutriafol which had 

been dissolved in methanol, at test concentrations of 100 g/mL and 1000 g/mL. The samples 

were thoroughly shaken and continuously mixed on an end-over-end shaker at 20  1C. After 

24 hours, all samples were centrifuged and aliquots of the supernatants were stored frozen at -15 

 2C.

For the “aged residues” samples, aliquots of the soils were extracted by refluxing in 

acetonitrile:pH 9 water. The extracts were cleaned up by liquid/liquid partition and adsorption 

chromatography on Florisil. Aliquots were analyzed for flutriafol using a gas chromatograph 

fitted with a nitrogen selective thermionic detector and the internal standardization technique. 

For the “freshly applied” samples, the thawed 24-hour aqueous supernatants were passed through 

a bonded phase C18 silica column which was then eluted with methanol. The eluent was 

evaporated to dryness under a stream of room temperature air and the residue was redissolved in 

hexane. Aliquots were analyzed for flutriafol using a gas chromatograph fitted with a nitrogen 

selective thermionic detector and the an internal standardization technique. Samples were not 

analyzed for transformation products of flutriafol.

For the “freshly applied” samples, the measured Kd values ranged from 1.4 to 73. Corresponding 

Koc values ranged from 110 to 590. For the “aged residues” samples, Kd values ranged from 2.4 

to 130. Corresponding Koc values ranged from 190 to 1300. This study is classified as 

supplemental. All soils used were foreign soils collected either from seven fields treated once 

three years previous to sampling, or from nine fields treated annually for nine years previous to 
124

soil sample collection. After all applications, the flutriafol was incorporated into the first 20 

centimeters soil, and allowed to age in the open environment. These “aged residues” were 

desorbed from the soils through reflux. Material balances were not determined. As a result, 

mobility values derived from this study should not be used as model input parameters. 

MRID 47345401 The behaviour of [triazole14C]-labeled (RS)-2,4′-difluoro-α-(1H-1,2,4-

triazol-1-ylmethyl)benzhydryl alcohol ([

14C]flutriafol) was studied in four European soils: a silty

clay soil and a silty clay loam soil , each from France; and a loam soil and a loamy sand soil,

each from Germany. This study was designed to evaluate the effect of time on the adsorption 

properties of flutriafol in soil. As such, the study was not designed as a typical batch equilibrium 

or column leaching study. The non-guideline study was comprised of what the study authors 

describe as a “time dependent sorption experiment” and a “concentration dependent sorption 

experiment”.

For the time dependent sorption experiment, the test soils were dried and sieved prior to use. 

[

14C]flutriafol was applied moistened soils at a rate of 0.117 mg a.i./kg in cylindrical metabolism 

flasks connected to individual flow-through volatile trapping systems. Soils were aged for up to 

308 days under aerobic conditions in darkness at 20  2C; duplicate samples were collected at 

0, 30, 70, 120, 203, and 308 days posttreatment. The aged soils were transferred to centrifuge 

tubes, 0.01M CaCl2 solution was added to yield soil solution ratios of 1:1 (w:v), and the tubes 

were shaken at 20  2C for 48 hours. For the concentration dependent sorption experiment, 

flasks were prepared as described for the time dependent sorption flasks, except that the test soils 

were treated with [14C]flutriafol at 0.012, 0.038, 0.117, 0.39, and 1.16 mg a.i./kg, and the 

samples were collected only at day 0. Traps were not employed. One extraction step was 

performed for each test soil.

All samples were centrifuged and aliquots of the supernatant solutions analyzed for total 

radioactivity using LSC; aliquots of the supernatant solutions were partitioned with ethyl acetate 

and analyzed for flutriafol using HPLC and TLC. The soil was further extracted with 

acetonitrile:water (4:1, v:v), up to three times by shaking and once by Soxhlet extraction; 

aliquots of the combined extracts were analyzed using LSC and HPLC. The presence of 

flutriafol was identified by comparison to an unlabeled reference standard; the identity of 

flutriafol was confirmed using TLC. Samples were also for transformation products of flutriafol.

In the time dependent sorption experiment, distribution coefficients (derived from the amount of 

flutriafol in the soil extracts to the concentration of flutriafol in the 0.01M CaCl2 solution) 

increased with time of aging; higher percentages in the extracts tracked with higher time-0 Kds.

In the concentration dependent sorption experiment, sorption of flutriafol increased with 

decreasing test concentration applied to the soils.

This non-guideline study is classified as providing ancillary information on the mobility of 

flutriafol in soils. An adsorption phase was not conducted for the time dependent sorption or 

concentration dependent sorption experiments, so it was not performed according to guidelines 

for adsorption/desorption studies. As a result, mobility values derived from this study should 

not be used as model input parameters. 
125

Bioconcentration in Fish

MRID 47090437 The bioaccumulation of [14C-triazole]labeled, [14C-carbinol]labeled, and 

unlabeled (RS)-2,4′-Difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol; 

specific activity 2.6 MBq/mmol), prepared as a mixture dissolved in methanol, was studied in 

bluegill sunfish (Lepomis macrochirus) at a nominal concentration of 50 mg/L under flowthrough conditions. The study was conducted in 1982 prior to the adoption of current 

registration guidelines, but was submitted under USEPA OPP Guideline 165-4. 

The test system consisted of two 80-L glass test aquaria. One was treated with [14C]flutriafol 

and one served as a control. The test aquaria were filled with aerated, dechlorinated “mains” 

dilution water at a flow rate of 250 mL/minute using calibrated flow-meters. [

14C]Flutriafol, 

dissolved in methanol, was delivered into the dilution water of the exposure aquarium. A 0.4% 

methanol solution was delivered into the dilution water of the control aquarium. The solutions 

were injected continuously into each aquarium, using a Series II Micrometering Pump, at flow 

rate of 1 mL/minute. The aquaria were equilibrated for 24 hours prior to addition of the fish. 

The fish were exposed for 21 days at ca. 18C. Following exposure, a 7-day depuration phase 

was initiated by transferring 60 of the remaining fish from the control and exposure test vessels 

to fresh test vessels that were continuously replenished with dilution water.

Seven fish were collected after 1, 3, 7, 14, and 21 days of exposure and after 1, 3, and 7 days of 

depuration. Three fish were frozen whole and analyzed by LSC following combustion. The 

remaining fish were separated into muscle and viscera tissue and analyzed by LSC following 

combustion.

Water samples were collected from the exposed and control vessels daily during the exposure 

period. Aliquots were analyzed directly by LSC. Additional water samples were collected from 

the treated test vessels after 0, 3, 10, 17, and 21 days of exposure, and were analyzed by LSC and 

TLC following solvent extraction.

Water quality parameters were reportedly monitored and maintained throughout the study period. 

Aeration was used to maintain the oxygen content in the water. The fish removed for analysis 

had a mean body weight of 0.87  0.23 g and a mean body length of 37.0  2.6 mm.

Based on TLC analysis of additional water samples collected on days 0, 3, 10, 17, and 21 of 

exposure, [14C]flutriafol was relatively stable, accounting for 86-93% of the recovered 

radioactivity. Flutriafol was the only compound detected.

In whole fish, muscle, and viscera tissues, [14C]flutriafol residues rapidly accumulated and 

reached a plateau within 3-21 days of exposure. Maximum BCF values were 6.8 for whole fish 

(day 3), 4.7 for muscle tissue (day 3), and 12.2 for viscera tissue (day 21).

During the 7-day depuration period, [14C]flutriafol residues in the whole fish decreased to a 

mean of 20% by 1 day, and to 2% by 7 days. In the muscle tissue, [14C]flutriafol residues 

decreased by a mean of 3% at 1 day of depuration. In the viscera tissue, [14C]flutriafol residues 

decreased to a mean of 31% by 1 day of depuration, and to 1-3% by 3-7 days depuration. This 
126

study is classified as acceptable. 

Terrestrial Field Dissipation

MRID 47090429 The dissipation of [triazole-3,5-U14C]-labeled (RS)-2,4′-difluoro-α-(1H1,2,4-triazol-1-ylmethyl)benzhydryl alcohol (flutriafol; radiochemical purity 99.9%) was studied 

in sandy loam, clay loam and sandy clay loam soils in the United Kingdom for 24 weeks under 

field conditions. [14C]Flutriafol was applied at a nominal rate of 250 g a.i./ha. This study does 

not appear to have been designed to fulfill Subdivision N guideline requirements. The test 

system consisted of a single treated field plot per site; the sandy loam soil was bare ground, 

while the clay loam and sandy clay loam soils were sown to barely just prior to treatment. The 

test solution was applied using a hand-pumped sprayer. Following treatment, duplicate soil 

cores were collected after 0, 6, 12 and 24 weeks from the sandy loam plot, and after 0, 5, 8 and 

24 weeks from the clay loam and sandy clay loam plots. Plants, when present, were pulled from 

the soil cores upon sampling and retained for analysis. Soil cores were segmented and reflux 

extracted twice with acetonitrile:water. Soil extracts, extracted soil and plant material were 

analyzed for total radioactivity using LSC. The initial extract was concentrated via rotary

evaporation, then analyzed for flutriafol and its transformation products via one-dimensional, 

normal-phase TLC against reference standard. Only one reference standard, flutriafol, was used 

for identification purposes. A second confirmatory method was not utilized.

Recoveries between replicate cores were highly variable, which the study authors attributed to 

the small number of samples taken at each interval and/or variability due to the hand-spraying 

application method. For all three soils, the majority of the [14C]residues were recovered in the 0-

to 10-cm soil depth at all intervals

Dissipation of parent flutriafol appeared fastest in the sandy loam and slowest in the clay loam, 

but significant variability of the results between replicate cores and between sampling intervals 

preclude any accurate interpretation of the results. Additionally, as the sandy loam soil was bare 

ground, but both the clay loam and sandy clay loam soils were cropped, what effect, if any, 

cropping may have had could not be assessed. No major transformation products were detected 

and no minor products were identified.

Flutriafol slowly dissipated under field conditions. Residues remained primarily in the 0- to 10-

cm soil horizon, with formation of bound soil residues and minor formation of at least one 

nonvolatile product.

At the sandy loam soil site, an additional test system consisted of plastic cylinders embedded into 

bare ground, and the soil within each cylinder was treated with [14C]flutriafol at 290 g a.i./ha. 

The test solution was applied dropwise via pipette to the soil surface. Following treatment, soil 

within half of the cylinders was planted with barley. During the initial 7 weeks posttreatment, 

half of the bare ground and half of the cropped cylinders were alternately covered with a glass 

dome connected to a flow-through system with traps for the collection of CO2 and volatile 

organics. Volatiles were collected for 24-hour intervals. An entire cylinder was sampled at 0, 3, 

12, 18 and 33 weeks posttreatment for the bare ground soil and at 3, 12 and 33 weeks for 
127

cropped soil. Plants, when present, were pulled from the soil upon sampling and retained for 

analysis. Soil and plant material were analyzed as described above. Trapping solutions were 

analyzed for total radioactivity by LSC.

There were no significant differences in the patterns of dissipation or recoveries of residues 

between the bare ground and cropped soil. The study authors noted that growth of the barley

was poor and none survived after 12 weeks; weeds were allowed to grow and collected as plant 

material. The majority of the [14C]residues were recovered in the 0- to 10-cm soil depth at all 

intervals. This study is classified as supplemental. No attempt was made to identify potentially 

toxic degradation products of flutriafol. It was not established that the foreign test soils, where 

this study was conducted, are comparable to soils that would be found at intended use sites for 

flutriafol in the United States. For the portion of this study conducted at the clay loam and 

sandy clay loam soil sites, results were too variable to accurately assess dissipation of flutriafol 

and its residues.

Results Synopsis:

Test system used: Sandy loam soil in the United Kingdom; bare ground plot.

Linear half-life: 15.1 weeks (r2= 0.5195).

Non-linear half-life: 17.0 weeks (r2= 0.5246).

Observed DT50: ca. 18 weeks.

Major transformation products: None detected.

Minor transformation products: None identified.

Test system used: Clay loam soil in the United Kingdom; cropped plot.

Linear half-life: 142 weeks (r2= 0.0061).

Non-linear half-life: 49.5 weeks (r2= 0.0494).

Observed DT50: ND (not determined).

Major transformation products: None detected.

Minor transformation products: None identified.

Test system used: Sandy clay loam soil in the United Kingdom; cropped plot.

Linear half-life: 42.2 weeks (r2= 0.0516).

Non-linear half-life: 32.4 weeks (r2= 0.0775).

Observed DT50: ND.

Major transformation products: None detected.

Minor transformation products: None identified.

Test system used: Sandy loam soil in the United Kingdom; bare ground + cropped, inground cylinders.

Linear half-life: 37.3 weeks (r2= 0.8794).

Non-linear half-life: 33.8 weeks (r2= 0.8784).

Observed DT50: ca. 30 weeks.

Major transformation products: None detected.

Minor transformation products: None identified.
128

MRID 47090431 Soil dissipation/accumulation of flutriafol ((RS)-2,4′-difluoro-α-(1H-1,2,4-

triazol-1-ylmethyl)benzhydryl alcohol) under European field conditions was studied using bare 

plots at six sites in Germany. The plots were sown with spring barley or oats following spring 

application of the test substance, or with winter wheat following fall application of the test 

substance to mimic normal agricultural practices. 

Soil textures were not reported for any of the test sites. The experiment was not carried out in 

accordance with any reported guidelines or standards. However, a portion of the laboratory

phase of the study was conducted in compliance with the Principles of Good Laboratory Practice 

laid down in the United Kingdom Department of Health Compliance programme (1989). 

Flutriafol was sprayed once at each test site at a target rate of 1.0 kg a.i./ha to 20 x 20 m plots at 

each site. Following application, the plots were raked to a depth of 2-3 cm to incorporate the test 

chemical. The maximum label rate was not reported. Total precipitation during the study period 

at each of the six test sites was not reported. A control plot was not specified.

The application rate was not verified at any of the six test sites using application monitoring 

devices. Field spikes were not prepared to determine the stability of the parent and 

transformation products during transport and storage.

Soil samples were collected from Site 1 from 102 to 1993 days, from Site 2 from 0 to 1779 days, 

from Site 3 from 0 to 2195 days, from Site 4 from 0 to 1814 days, from Site 5 from 109 to 1299 

days, and from Site 6 from 102 to 2010 days following the test application to a depth of 0-30 cm. 

Soil cores were generally sectioned into 0-5, 5-10, 10-20, and 20-30 cm segments. Soil samples 

were reflux extracted with acetonitrile:pH 9 water, partitioned into dichloromethane, cleaned-up 

using adsorption chromatography, and analyzed for flutriafol by gas-liquid chromatography with 

nitrogen selective detection. Samples were not analyzed for transformation products of 

flutriafol. 

This study is classified supplemental. In spite of the deficiencies in this study, sampling was 

conducted for a sufficient length of time to demonstrate the persistence of flutriafol on the order 

of years in terrestrial environments, and that detections of flutriafol at the bottom of the sampled 

column shows an ability to slowly leach through the soil profile. A storage stability study was 

not conducted. No attempt was made to identify potentially toxic minor degradation products of 

flutriafol. Sampling was not conducted to a sufficient depth to define leaching. Soil was not 

characterized, and the registrant did not demonstrate comparability between the test site soil and 

U.S. soil.

RESULTS SYNOPSIS

Site 1

Location/soil type: Lichtenhagen, Germany/Not reported.

Half-life: 1155 days (r2= 0.8479; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.
129

Site 2

Location/soil type: Lichtenhagen, Germany/Not reported.

Half-life: 866 days (r2= 0.8353; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 3

Location/soil type: Mottingen, Germany/Not reported.

Half-life: 770 days (r2= 0.8308; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 4

Location/soil type: Damsdorf, Germany/Not reported.

Half-life: 866 days (r2= 0.7031; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 5

Location/soil type: Bohringen, Germany/Not reported.

Half-life: 1155 days (r2= 0.5453; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 6

Location/soil type: Wankendorf, Germany/Not reported.

Half-life: 1386 days (r2= 0.7094; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

MRID 47090432 Soil dissipation/accumulation of flutriafol ((RS)-2,4′-difluoro-α-(1H-1,2,4-

triazol-1-ylmethyl)benzhydryl alcohol) under European field conditions was studied using bare 

plots at three sites in France. Following application, the plots were generally cultivated and 

cropped in each year of the study following normal agricultural practices. Flutriafol was sprayed 

once at each test site at a target rate of 1.0 kg a.i./ha to 20 x 20 m plots at each site; plots were 

not replicated. Following application, the plots were raked to a depth of 2-3 cm to incorporate 

the test chemical. Total precipitation during the study period at each of the three test sites was 

not reported. A control plot was located an unspecified distance from the treated plot at each test 
130

site.

The application rate was not verified at any of the three test sites using application monitoring 

devices. Field spikes were not prepared to determine the stability of the parent and 

transformation products during transport and storage.

Samples were collected from Site 1 at 0, 113, 174, 264, 357, 448, 547, 625, 714, 832, 933, 1079, 

1282, and 1459 days, from Site 2 at 0, 96, 189, 272, 378, 541, 776, 904, 1148, 1308, and 1526 

days and from Site 3 at 87, 180, 277, 362, 551, and 723 days following the test application to a 

depth of 0-30 cm, and were sectioned into 0-5, 5-10, 10-20, and 20-30 cm segments. Soil 

samples were reflux extracted with acetonitrile:pH 9 water, partitioned into dichloromethane, 

cleaned-up using adsorption chromatography, and analyzed for flutriafol by gas-liquid 

chromatography with nitrogen selective detection. Samples were not analyzed for 

transformation products of flutriafol. The storage interval of the test samples prior to analysis 

was not reported.

The major route of dissipation of flutriafol under terrestrial field conditions could not be 

determined because soil was not analyzed for transformation products of flutriafol, leaching was 

not adequately determined, and volatilization, plant uptake, and runoff were not studied. This 

study is classified supplemental. In spite of the deficiencies in this study, sampling was 

conducted for a sufficient length of time to demonstrate the persistence of flutriafol on the order 

of years in terrestrial environments, and that detections of flutriafol at the bottom of the sampled 

column shows an ability to slowly leach through the soil profile. A storage stability study was 

not conducted. No attempt was made to identify potentially toxic minor degradation products of 

flutriafol. Sampling was not conducted to a sufficient depth to define leaching. A site use 

history was not provided for any of the three test sites. The limit of quantitation of the analytical 

method was not reported. Soil samples were excessively composited. Soil was not 

characterized, and the registrant did not demonstrate comparability between the test site soil and 

U.S. soil.

RESULTS SYNOPSIS

Site 1 (Toulouse 71/82)

Location/soil type: Toulouse, France/Sandy clay loam.

Half-life: 990 days (r2= 0.6449; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 2 (Tours 84/82)

Location/soil type: Tours, France/Clay.

Half-life: 408 days (r2= 0.7780; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.
131

Site 3 (Tours 73/82)

Location/soil type: Tours, France/Silty clay.

Half-life: 1733 days (r2= 0.1586; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

MRID 47090433 Soil dissipation/accumulation of flutriafol ((RS)-2,4′-difluoro-α-(1H-1,2,4-

triazol-1-ylmethyl)benzhydryl alcohol) under European field conditions was studied using 

cropped plots at six sites in Germany. Soil textures were not reported for any of the test sites. 

Flutriafol was applied as a foliar spray at each test site to test plots approximately 0.5-1.2 ha 

using multiple application. Flutriafol was applied annually, between late April and late June, at a 

target rate of 0.188 kg a.i./ha for the first application and 0.25 kg a.i./ha for subsequent 

applications. The maximum label rate was not reported. Total precipitation during the study 

period at each of the six test sites was not reported. Control samples were analyzed alongside 

test samples.

The application rate was not verified at any of the six test sites using application monitoring 

devices. Field spikes were not prepared to determine the stability of the parent and 

transformation products during transport and storage.

Soil samples were collected from each test site at harvest and in the spring of the following year, 

following each test application; day 0 samples were not collected. Soil cores were collected to a 

nominal depth of 0-30 cm and were not sectioned. Soil samples were reflux extracted with 

acetonitrile:pH 9 water, partitioned into dichloromethane, cleaned-up using adsorption 

chromatography, and analyzed for flutriafol by gas-liquid chromatography with nitrogen 

selective detection. The LOD was 0.005-0.01 mg/kg. Samples were not analyzed for 

transformation products of flutriafol. The storage interval of the test samples prior to analysis 

was not reported.

Half-lives and DT90 values could not be calculated for flutriafol for any of the six test sites 

because flutriafol residues generally increased annually with each test application and an 

insufficient number of samples was collected following the final application to track the 

dissipation of flutriafol. Following the last application, soil was only sampled for flutriafol at 

harvest and in the spring of the following year or only at harvest. Carryover of residues was 

27% of the total applied flutriafol at Site 1 at the end of the 1563-day study period. 

The major route of dissipation of flutriafol under terrestrial field conditions at the six test sites 

could not be determined because an insufficient number of samples were collected following the 

final application to track the dissipation of flutriafol. This study is classified supplemental. The 

pattern of formation and decline of the transformation products of flutriafol could not be 

determined. Sampling was not conducted to a sufficient depth to define leaching. A complete 

site use history was not provided for any of the six test sites. Soil samples were excessively 

composited. The registrant did not demonstrate comparability between the test site soil and U.S. 

soil.
132

RESULTS SYNOPSIS

Site 1

Location/soil type: Wankendorf, Germany/Not reported.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 2

Location/soil type: Petersdorf, Germany/Not reported.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 3

Location/soil type: Lichtenhagen, Germany/Not reported.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 4

Location/soil type: Neubruchausen, Germany/Not reported.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 5

Location/soil type: Mottingen, Germany/Not reported.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 6

Location/soil type: Bohringen, Germany/Not reported.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

MRID 47090434 Soil dissipation/accumulation of flutriafol ((RS)-2,4′-difluoro-α-(1H-1,2,4-
133

triazol-1-ylmethyl)benzhydryl alcohol) under European field conditions was studied using 

cropped plots at four sites in France. The classification system used for the textural classification 

was not reported. The experiment was not carried out in accordance with any reported 

guidelines or standards. Flutriafol was applied as a foliar spray at each test site to test plots 

ranging from 0.1 to 1.0 ha using multiple applications. Flutriafol was applied annually. The 

maximum label rate was not reported. Total precipitation during the study period at each of the 

four test sites was not reported. Control plots were not specified.

The application rate was not verified at any of the four test sites using application monitoring 

devices. Field spikes were not prepared to determine the stability of the parent and 

transformation products during transport and storage.

Soil samples were collected from each test site at harvest and in the spring of the following year, 

following each test application. Day 0 samples were not collected. Soil samples were reflux 

extracted with acetonitrile:pH 9 water, partitioned into dichloromethane, cleaned-up using 

adsorption chromatography, and analyzed for flutriafol by gas-liquid chromatography with 

nitrogen selective detection. The LOD was 0.005-0.01 mg/kg. Samples were not analyzed for 

transformation products of flutriafol. The storage interval of the test samples prior to analysis 

was not reported.

Half-lives and DT90 values could not be calculated for flutriafol for any of the four test sites 

because flutriafol residues generally increased annually with each test application, and an 

insufficient number of samples was collected following the final application to track the 

dissipation of flutriafol. Following the last application at each test site in 1989, soil was only

sampled for flutriafol at harvest. 

The major route of dissipation of flutriafol under terrestrial field conditions at the four test sites 

could not be determined because an insufficient number of samples was collected following the 

final application to track the dissipation of flutriafol. Additionally, soil was not analyzed for 

transformation products of flutriafol, leaching was not determined, and volatilization, plant 

uptake, and runoff were not studied. This study is classified supplemental. No significant 

deviations from good scientific practices were noted. Half-lives of flutriafol could not be 

calculated. A storage stability study was not conducted. The pattern of formation and decline of 

the transformation products of flutriafol could not be determined. A complete site use history

was not provided for any of the four test sites. The limit of quantitation of the analytical method 

was not reported. Soil samples were excessively composited. Soil was not adequately 

characterized. The registrant did not demonstrate comparability between the test site soil and 

U.S. soil.

RESULTS SYNOPSIS

Site 1

Location/soil type: VilleFranche, France/Sandy.

Half-life: Could not be determined.

DT90: Could not be determined.
134

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 2

Location/soil type: Tours, France/Chalk.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 3

Location/soil type: Toulouse, France/Sandy clay loam.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 4

Location/soil type: Reims, France/Chalk.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

MRID 47090435 Soil dissipation/accumulation of flutriafol ((RS)-2,4′-difluoro-α-(1H-1,2,4-

triazol-1-ylmethyl)benzhydryl alcohol) under European field conditions was studied using 

cropped plots at six sites in the United Kingdom. Flutriafol was applied as a foliar spray at each 

test site to test plots of approximately 1 ha using multiple applications. Flutriafol was applied 

annually, between late March and early July, at a target rate of 0.188 kg a.i./ha for the first 

application and 0.25 kg a.i./ha for subsequent applications. The maximum label rate was not 

reported. Total precipitation during the study period at each of the six test sites was not reported. 

Control plots were not specified.

The application rate was not verified at any of the six test sites using application monitoring 

devices. Field spikes were not prepared to determine the stability of the parent and 

transformation products during transport and storage.

Soil samples were generally collected from each test site at harvest and in the spring of the 

following year, following each test application, but were generally not collected in the spring 

following the last application. Day 0 samples were not collected. Soil cores were collected to a 

nominal depth of 0-30 cm and were not sectioned. Soil samples were reflux extracted with 

acetonitrile:pH 9 water (ratio not reported), partitioned into dichloromethane, cleaned-up using 

adsorption chromatography, and analyzed for flutriafol by gas-liquid chromatography with 

nitrogen selective detection. The LOD was 0.005-0.01 mg/kg. Samples were not analyzed for 

transformation products of flutriafol. The storage interval of the test samples prior to analysis 
135

was not reported. The reported calculated mass accounting was based on the measurement of 

flutriafol in the 0-30 cm soil depth and the cumulative applied rate of flutriafol. 

Half-lives and DT90 values could not be calculated for flutriafol for any of the six test sites 

because flutriafol residues generally increased annually with each test application, and an 

insufficient number of samples was collected following the final application to track the 

dissipation of flutriafol. Following the last application, soil was only sampled for flutriafol at 

harvest or at harvest and in the spring of the following year. 

The major route of dissipation of flutriafol under terrestrial field conditions at the six test sites 

could not be determined because an insufficient number of samples were collected following the 

final application to track the dissipation of flutriafol. Additionally, soil was not analyzed for 

transformation products of flutriafol, leaching was not determined, and volatilization, plant 

uptake, and runoff were not studied. This study is classified supplemental. Half-lives of 

flutriafol could not be calculated. A storage stability study was not conducted. The pattern of 

formation and decline of the transformation products of flutriafol could not be determined. 

Sampling was not conducted to a sufficient depth to define leaching. A site use history was not 

provided for any of the six test sites. The limit of quantitation of the analytical method was not 

reported. Soil samples were excessively composited. The registrant did not demonstrate 

comparability between the test site soil and U.S. soil.

RESULTS SYNOPSIS

Site 1

Location/soil type: Boxford, United Kingdom/Clay loam.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 2

Location/soil type: Benson, United Kingdom/Clay loam.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 3

Location/soil type: Chalgrove, United Kingdom/Sandy clay loam.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 4
136

Location/soil type: West Horsley, United Kingdom/Loamy sand.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 5

Location/soil type: Stanton St John, United Kingdom/Clay loam.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 6

Location/soil type: White Waltham, United Kingdom/Sandy loam.

Half-life: Could not be determined.

DT90: Could not be determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

MRID 47115502 Soil dissipation/accumulation of flutriafol ((RS)-2,4′-difluoro-α-(1H-1,2,4-

triazol-1-ylmethyl)benzhydryl alcohol) under European field conditions was studied using bare 

plots at three sites in the United Kingdom. Following application, the plots were generally 

cultivated and cropped in each year of the study following normal agricultural practices. This 

experiment was not carried out in accordance with any reported guidelines or standards. 

Flutriafol was sprayed once at each test site at a target rate of 1.0 kg a.i./ha to 20 x 20 m plots at 

each site. Plots were not replicated. Following application, the plots were raked to a depth of 2-3 

cm to incorporate the test chemical. The maximum label rate was not reported. Total 

precipitation during the study period at each of the three test sites was not reported. A control 

plot was established at each test site, control plots were located an unspecified distance from the 

treated plot.

The application rate was not verified at any of the three test sites using application monitoring 

devices. Field spikes were not prepared to determine the stability of the parent and 

transformation products during transport and storage.

However, the final four cores were collected at Site 1, the final three cores collected at Site 2 and 

the final two cores collected at Site 3 were not sectioned, and were analyzed as a bulk 0-30 cm 

sample. Soil samples were reflux extracted with acetonitrile:pH 9 water, partitioned into 

dichloromethane, cleaned-up using adsorption chromatography, and analyzed for flutriafol by 

gas-liquid chromatography with nitrogen selective detection. The LOD was 0.01 mg/kg. 

Samples were not analyzed for transformation products of flutriafol. The storage interval of the 

test samples prior to analysis was not reported.

As is common with terrestrial field dissipation studies, there was a more rapid decline through 
137

the top 5 cm of the soil profile during the initial year of the study. The DT90 was not determined. 

The major route of dissipation of flutriafol under terrestrial field conditions at the three test sites 

could not be determined because soil was not analyzed for transformation products of flutriafol, 

leaching was not adequately determined and volatilization, plant uptake, and runoff were not 

studied. This study is classified as supplemental. In spite of the deficiencies in this study, 

sampling was conducted for a sufficient length of time to demonstrate the persistence of 

flutriafol in terrestrial environments. A storage stability study was not conducted. The pattern of 

formation and decline of the transformation products of flutriafol could not be determined. 

Sampling was not conducted to a sufficient depth to differentiate between degradation and 

leaching. A site use history was not provided for any of the three test sites. The limit of 

quantitation of the analytical method was not reported. Soil samples were excessively

composited. Finally, the registrant did not demonstrate comparability between the test site soil 

and U.S. soil.

RESULTS SYNOPSIS

Site 1

Location/soil type: West Horsley, United Kingdom/Loamy sand.

Half-life: 1155 days (r2= 0.9158; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 2

Location/soil type: Boxford, United Kingdom/Clay loam.

Half-life: 3466 days (r2= 0.4350; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.

Site 3

Location/soil type: Chalgrove, United Kingdom/Sandy clay loam.

Half-life: 2310 days (r2= 0.4531; based on all data from the total 0- to 30-cm soil profile).

DT90: Not determined.

Major transformation products detected: Samples not analyzed for transformation products.

Dissipation routes: Could not be determined.
138

Table 2: Summary of Carry-Over Values from Terrestrial Field Dissipation Studies

Percent Flutriafol Residue Carryover Study Termination at 

0Day Post-Treatment

Approximate Number of 

Years Post-Treatment

15% 1993 day approximately 51⁄2 years

13% 1779 day approximately 5 years

9% 2195 day approximately 6 years

17% 1814 day approximately 5 years

17% 1299 day approximately 31⁄2 years

23% 2010 day approximately 51⁄2 years

18% 459 day approximately 4 years

4% 1526 day approximately 4 years

37% 723 day approximately 2 years

27% 1563 day

19% 1457 day

23% 1399 day

48% 1375 day

17% 1539 day

9% 1172 day

11% 2634 day

19% 2639 day

11% 2675 day

16% 2638 day

45% 2998 day

36% 3013 day

41% 2895 day

35% 2989 day

49% 2998 day

26% 485 day

9% 3050 day >8 years

34% 3044 day >8 years

14% 2670 day >7 years

Non-Guideline

MRID 47090436 The biotransformation of flutriafol [(RS)-2,4′-difluoro-α-(1H-1,2,4-triazol1-ylmethyl)benzhydryl alcohol] was re-assessed using existing experimental datasets for 

laboratory soil degradation, field dissipation and water/sediment system studies to obtain first 

order DT50 and DT90 values by non-linear regression analysis. Since this study report contains 

no original data, GLP Standards do not apply. In accordance with the proposed FOCUS kinetics 

group recommendations, DT50 and DT90 values were calculated from existing raw data using first 

order non-linear regression analysis as determined by the Solver program within Microsoft Excel 

(2002). Goodness of fit was assessed two ways, by a formal statistical approach using 

coefficient of determination (r2) and through personal judgment, ‘by eye’. 
139

Appendix B. Aquatic Exposure Modeling and Results 

1. GENEEC2 EECs

Apples, Ground application

 RUN No. 1 FOR flutriafol ON apples * INPUT VALUES * 

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

 RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP

 ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

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

 .110( .659) 4 7 140.0 130.0 GRHIFI( 6.6) .0 .0

 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) 

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

 METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED

 (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) 

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

 8665.00 2 N/A .00- .00 .00 .00

 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 May 1, 2001

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

 PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

 GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

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

 21.24 21.22 21.11 20.87 20.70

Soybeans, Ground application (21-day intervals)

 RUN No. 2 FOR flutriafol ON soybean * INPUT VALUES * 

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

 RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP

 ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

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

 .060( .180) 3 21 140.0 130.0 AERL_B( 13.0) .0 .0

 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) 

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

 METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED

 (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) 

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

 8665.00 2 N/A .00- .00 .00 .00

 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 May 1, 2001

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

 PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

 GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

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

 9.00 8.99 8.95 8.85 8.78
140

Soybeans, Ground application (14-day intervals)

 RUN No. 3 FOR flutriafol ON soy * INPUT VALUES * 

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

 RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP

 ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

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

 .060( .180) 3 14 140.0 130.0 GRHIFI( 6.6) .0 .0

 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) 

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

 METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED

 (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) 

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

 8665.00 2 N/A .00- .00 .00 .00

 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

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

 PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

 GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

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

 8.69 8.68 8.64 8.54 8.47

Soybeans, Aerial application (21-day intervals)

RUN No. 4 FOR flutriafol ON soybean * INPUT VALUES * 

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

 RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP

 ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

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

 .060( .180) 3 21 140.0 130.0 GRHIFI( 6.6) .0 .0

 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) 

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

 METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED

 (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) 

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

 8665.00 2 N/A .00- .00 .00 .00

 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 May 1, 2001

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

 PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

 GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

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

 8.68 8.68 8.63 8.53 8.46

 
141

Soybeans, Aerial application (14-day intervals)

 RUN No. 5 FOR flutriafol ON soy bean * INPUT VALUES * 

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

 RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP

 ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

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

 .060( .180) 3 14 140.0 130.0 AERL_A( 24.1) .0 .0

 FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) 

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

 METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED

 (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) 

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

 8665.00 2 N/A .00- .00 .00 .00

 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

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

 PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

 GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

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

 10.13 10.13 10.08 9.97 9.90

2. PRZM/EXAMs EECs 

NC APPLE 

stored as NCapp.out

Chemical: Flutriafol

PRZM environment: NCappleSTD.txt modified Tueday, 29 May 2007 at 12:58:16

EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 05:14:08

Metfile: w03812.dvf modified Tueday, 26 August 2008 at 05:14:10

Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1965 3.2 3.136 2.901 2.595 2.358 1.12

1966 4.898 4.822 4.655 4.224 3.89 2.354

1967 4.896 4.843 4.667 4.175 3.89 2.716

1968 4.125 4.062 3.857 3.483 3.264 2.422

1969 2.981 2.959 2.83 2.619 2.457 1.857

1970 2.173 2.145 2.064 1.9 1.821 1.396

1971 2.743 2.705 2.59 2.444 2.28 1.469

1972 3.684 3.631 3.418 3.272 3.132 1.988

1973 11.18 11.05 10.25 8.795 7.938 4.32

1974 5.298 5.236 5.026 4.77 4.541 3.57

1975 6.416 6.314 5.922 5.419 5.04 3.32

1976 9.327 9.186 8.619 7.54 6.886 4.315

1977 4.218 4.174 4.068 3.914 3.74 3.129

1978 3.621 3.566 3.4 3.179 3 2.215

1979 3.028 2.984 2.896 2.645 2.495 1.813

1980 5.808 5.71 5.439 4.784 4.332 2.481

1981 6.999 6.896 6.597 5.708 5.174 3.213
142

1982 4.131 4.074 3.897 3.547 3.327 2.606

1983 3.27 3.223 3.101 2.899 2.689 1.951

1984 4.377 4.313 4.033 3.742 3.484 2.26

1985 2.614 2.584 2.46 2.303 2.214 1.791

1986 2.914 2.872 2.717 2.386 2.197 1.524

1987 12.39 12.14 11.27 9.722 8.739 4.391

1988 4.65 4.608 4.51 4.428 4.344 3.609

1989 4.848 4.798 4.554 4.194 3.955 2.809

1990 4.338 4.279 4.024 3.663 3.515 2.509

Sorted results

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

0.037037037037037 12.39 12.14 11.27 9.722 8.739 4.391

0.0740740740740741 11.18 11.05 10.25 8.795 7.938 4.32

0.111111111111111 9.327 9.186 8.619 7.54 6.886 4.315

0.148148148148148 6.999 6.896 6.597 5.708 5.174 3.609

0.185185185185185 6.416 6.314 5.922 5.419 5.04 3.57

0.222222222222222 5.808 5.71 5.439 4.784 4.541 3.32

0.259259259259259 5.298 5.236 5.026 4.77 4.344 3.213

0.296296296296296 4.898 4.843 4.667 4.428 4.332 3.129

0.333333333333333 4.896 4.822 4.655 4.224 3.955 2.809

0.37037037037037 4.848 4.798 4.554 4.194 3.89 2.716

0.407407407407407 4.65 4.608 4.51 4.175 3.89 2.606

0.444444444444444 4.377 4.313 4.068 3.914 3.74 2.509

0.481481481481481 4.338 4.279 4.033 3.742 3.515 2.481

0.518518518518518 4.218 4.174 4.024 3.663 3.484 2.422

0.555555555555556 4.131 4.074 3.897 3.547 3.327 2.354

0.592592592592593 4.125 4.062 3.857 3.483 3.264 2.26

0.62962962962963 3.684 3.631 3.418 3.272 3.132 2.215

0.666666666666667 3.621 3.566 3.4 3.179 3 1.988

0.703703703703704 3.27 3.223 3.101 2.899 2.689 1.951

0.740740740740741 3.2 3.136 2.901 2.645 2.495 1.857

0.777777777777778 3.028 2.984 2.896 2.619 2.457 1.813

0.814814814814815 2.981 2.959 2.83 2.595 2.358 1.791

0.851851851851852 2.914 2.872 2.717 2.444 2.28 1.524

0.888888888888889 2.743 2.705 2.59 2.386 2.214 1.469

0.925925925925926 2.614 2.584 2.46 2.303 2.197 1.396

0.962962962962963 2.173 2.145 2.064 1.9 1.821 1.12

0.1 9.8829 9.7452 9.1083 7.9165 7.2016 4.3165

Average of yearly averages: 2.58261538461539

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run:

Output File: NCapp

Metfile: w03812.dvf

PRZM scenario: NCappleSTD.txt

EXAMS environment file: pond298.exv

Chemical Name: Flutriafol

Description Variable Name Value Units Comments

Molecular weight mwt 301.3 g/mol

Henry's Law Const. henry 1.3E-11 atm-m^3/mol

Vapor Pressure vapr 3E-9 torr

Solubility sol 130 mg/L

Kd Kd mg/L

Koc Koc 322 mg/L

Photolysis half-life kdp days Half-life

Aerobic Aquatic Metabolism kbacw 100 days Halfife

Anaerobic Aquatic Metabolism kbacs 365 days Halfife

Aerobic Soil Metabolism asm 3247 days Halfife

Hydrolysis: pH 7 days Half-life

Method: CAM 2 integer See PRZM manual

Incorporation Depth: DEPI cm

Application Rate: TAPP 0.1232 kg/ha

Application Efficiency: APPEFF 0.95 fraction

Spray Drift DRFT 0.05 fraction of application rate applied to pond

Application Date Date 1-5 dd/mm or dd/mmm or dd-mm or dd-mmm

Interval 1 interval 7 days Set to 0 or delete line for single app.

app. rate 1 apprate 0.1232 kg/ha
143

Interval 2 interval 7 days Set to 0 or delete line for single app.

app. rate 2 apprate 0.1232 kg/ha

Interval 3 interval 7 days Set to 0 or delete line for single app.

app. rate 3 apprate 0.1232 kg/ha

Record 17:FILTRA

IPSCND 1

UPTKF

Record 18:PLVKRT

PLDKRT

FEXTRC 0.5

Flag for Index Res. Run IR EPA Pond

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

OR APPLE

stored as ORapp.out

Chemical: Flutriafol

PRZM environment: ORappleSTD.txt modified Tueday, 29 May 2007 at 13:00:08

EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 05:14:08

Metfile: w24232.dvf modified Tueday, 26 August 2008 at 05:15:54

Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 1.129 1.111 1.039 0.9153 0.8408 0.4777

1962 1.769 1.749 1.666 1.55 1.506 1.159

1963 2.871 2.837 2.711 2.531 2.393 1.894

1964 2.886 2.86 2.75 2.577 2.449 2.121

1965 2.823 2.798 2.693 2.523 2.396 2.108

1966 2.919 2.891 2.778 2.602 2.474 2.178

1967 2.975 2.948 2.831 2.645 2.508 2.156

1968 2.827 2.796 2.743 2.567 2.436 2.119

1969 2.718 2.686 2.559 2.451 2.388 2.113

1970 2.824 2.797 2.683 2.501 2.369 2.016

1971 2.644 2.619 2.518 2.397 2.293 2.042

1972 2.99 2.958 2.831 2.624 2.467 2.003

1973 2.763 2.736 2.625 2.454 2.328 1.981

1974 3.039 3.021 2.923 2.674 2.24 1.882

1975 3.107 3.078 2.962 2.788 2.655 2.298

1976 2.78 2.754 2.651 2.486 2.366 1.921

1977 2.418 2.393 2.292 2.117 1.998 1.566

1978 2.819 2.785 2.657 2.432 2.259 1.655

1979 2.489 2.469 2.408 2.321 2.211 1.858

1980 2.749 2.723 2.626 2.561 2.449 2.068

1981 3.24 3.204 3.082 2.865 2.739 2.334

1982 2.914 2.887 2.77 2.585 2.454 2.061

1983 2.586 2.558 2.449 2.284 2.187 1.804

1984 2.679 2.65 2.531 2.412 2.316 1.775

1985 2.955 2.917 2.786 2.539 2.404 1.895

1986 2.605 2.579 2.469 2.293 2.174 1.78

1987 2.89 2.867 2.816 2.228 2.064 1.793

1988 3.03 3.003 2.92 2.751 2.619 2.254

1989 2.728 2.701 2.59 2.414 2.291 2.012

1990 2.871 2.847 2.735 2.558 2.423 2.087

Sorted results

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

0.032258064516129 3.24 3.204 3.082 2.865 2.739 2.334

0.0645161290322581 3.107 3.078 2.962 2.788 2.655 2.298

0.0967741935483871 3.039 3.021 2.923 2.751 2.619 2.254

0.129032258064516 3.03 3.003 2.92 2.674 2.508 2.178

0.161290322580645 2.99 2.958 2.831 2.645 2.474 2.156

0.193548387096774 2.975 2.948 2.831 2.624 2.467 2.121

0.225806451612903 2.955 2.917 2.816 2.602 2.454 2.119

0.258064516129032 2.919 2.891 2.786 2.585 2.449 2.113

0.290322580645161 2.914 2.887 2.778 2.577 2.449 2.108

0.32258064516129 2.89 2.867 2.77 2.567 2.436 2.087
144

0.354838709677419 2.886 2.86 2.75 2.561 2.423 2.068

0.387096774193548 2.871 2.847 2.743 2.558 2.404 2.061

0.419354838709677 2.871 2.837 2.735 2.539 2.396 2.042

0.451612903225806 2.827 2.798 2.711 2.531 2.393 2.016

0.483870967741936 2.824 2.797 2.693 2.523 2.388 2.012

0.516129032258065 2.823 2.796 2.683 2.501 2.369 2.003

0.548387096774194 2.819 2.785 2.657 2.486 2.366 1.981

0.580645161290323 2.78 2.754 2.651 2.454 2.328 1.921

0.612903225806452 2.763 2.736 2.626 2.451 2.316 1.895

0.645161290322581 2.749 2.723 2.625 2.432 2.293 1.894

0.67741935483871 2.728 2.701 2.59 2.414 2.291 1.882

0.709677419354839 2.718 2.686 2.559 2.412 2.259 1.858

0.741935483870968 2.679 2.65 2.531 2.397 2.24 1.804

0.774193548387097 2.644 2.619 2.518 2.321 2.211 1.793

0.806451612903226 2.605 2.579 2.469 2.293 2.187 1.78

0.838709677419355 2.586 2.558 2.449 2.284 2.174 1.775

0.870967741935484 2.489 2.469 2.408 2.228 2.064 1.655

0.903225806451613 2.418 2.393 2.292 2.117 1.998 1.566

0.935483870967742 1.769 1.749 1.666 1.55 1.506 1.159

0.967741935483871 1.129 1.111 1.039 0.9153 0.8408 0.4777

0.1 3.0381 3.0192 2.9227 2.7433 2.6079 2.2464

Average of yearly averages: 1.91369

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run:

Output File: ORapp

Metfile: w24232.dvf

PRZM scenario: ORappleSTD.txt

EXAMS environment file: pond298.exv

Chemical Name: Flutriafol

Description Variable Name Value Units Comments

Molecular weight mwt 301.3 g/mol

Henry's Law Const. henry 1.3E-11 atm-m^3/mol

Vapor Pressure vapr 3E-9 torr

Solubility sol 130 mg/L

Kd Kd mg/L

Koc Koc 322 mg/L

Photolysis half-life kdp days Half-life

Aerobic Aquatic Metabolism kbacw 100 days Halfife

Anaerobic Aquatic Metabolism kbacs 365 days Halfife

Aerobic Soil Metabolism asm 3247 days Halfife

Hydrolysis: pH 7 days Half-life

Method: CAM 2 integer See PRZM manual

Incorporation Depth: DEPI cm

Application Rate: TAPP 0.1232 kg/ha

Application Efficiency: APPEFF 0.95 fraction

Spray Drift DRFT 0.05 fraction of application rate applied to pond

Application Date Date 1-5 dd/mm or dd/mmm or dd-mm or dd-mmm

Interval 1 interval 7 days Set to 0 or delete line for single app.

app. rate 1 apprate 0.1232 kg/ha

Interval 2 interval 7 days Set to 0 or delete line for single app.

app. rate 2 apprate 0.1232 kg/ha

Interval 3 interval 7 days Set to 0 or delete line for single app.

app. rate 3 apprate 0.1232 kg/ha

Record 17:FILTRA

IPSCND 1

UPTKF

Record 18:PLVKRT

PLDKRT

FEXTRC 0.5

Flag for Index Res. Run IR EPA Pond

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

PA APPLE
145

stored as PAapp.out

Chemical: Flutriafol

PRZM environment: PAappleSTD_V2.txt modified Tueday, 20 May 2008 at 12:00:22

EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 05:14:08

Metfile: w14751.dvf modified Tueday, 26 August 2008 at 05:15:00

Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 2.565 2.51 2.369 2.087 1.912 0.9281

1962 2.312 2.275 2.134 2.008 1.902 1.427

1963 2.064 2.038 1.991 1.828 1.723 1.305

1964 2.675 2.628 2.454 2.262 2.136 1.502

1965 2.185 2.155 2.073 1.956 1.855 1.405

1966 5.799 5.69 5.307 4.764 4.484 2.14

1967 4.601 4.529 4.254 3.933 3.882 3.336

1968 6.769 6.719 6.3 5.443 4.912 3.247

1969 5.366 5.264 4.962 4.353 4.028 3.012

1970 3.687 3.652 3.564 3.371 3.269 2.631

1971 3.022 2.986 2.86 2.623 2.486 1.997

1972 8.857 8.689 8.009 6.755 6.078 3.404

1973 6.171 6.097 5.712 4.995 4.608 3.44

1974 3.73 3.684 3.534 3.326 3.151 2.463

1975 3.757 3.7 3.465 3.251 3.096 2.231

1976 3.578 3.516 3.308 3.027 2.822 2.015

1977 2.359 2.328 2.207 2.134 2.048 1.581

1978 3.098 3.047 2.939 2.785 2.699 1.764

1979 3.291 3.244 3.083 2.824 2.638 1.839

1980 4.116 4.051 3.812 3.334 3.057 1.983

1981 2.454 2.425 2.302 2.235 2.158 1.703

1982 8.007 7.888 7.559 6.662 6.05 3.293

1983 5.382 5.317 5.049 4.461 4.115 3.088

1984 6.364 6.27 5.929 5.425 4.958 3.15

1985 4.795 4.735 4.639 4.277 3.976 2.891

1986 3.29 3.249 3.09 2.783 2.781 2.306

1987 3.794 3.729 3.473 3.061 2.929 2.167

1988 3.102 3.076 2.931 2.631 2.527 1.93

1989 4.212 4.15 3.904 3.805 3.604 2.338

1990 6.471 6.372 5.916 5.15 4.706 2.984

Sorted results

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

0.032258064516129 8.857 8.689 8.009 6.755 6.078 3.44

0.0645161290322581 8.007 7.888 7.559 6.662 6.05 3.404

0.0967741935483871 6.769 6.719 6.3 5.443 4.958 3.336

0.129032258064516 6.471 6.372 5.929 5.425 4.912 3.293

0.161290322580645 6.364 6.27 5.916 5.15 4.706 3.247

0.193548387096774 6.171 6.097 5.712 4.995 4.608 3.15

0.225806451612903 5.799 5.69 5.307 4.764 4.484 3.088

0.258064516129032 5.382 5.317 5.049 4.461 4.115 3.012

0.290322580645161 5.366 5.264 4.962 4.353 4.028 2.984

0.32258064516129 4.795 4.735 4.639 4.277 3.976 2.891

0.354838709677419 4.601 4.529 4.254 3.933 3.882 2.631

0.387096774193548 4.212 4.15 3.904 3.805 3.604 2.463

0.419354838709677 4.116 4.051 3.812 3.371 3.269 2.338

0.451612903225806 3.794 3.729 3.564 3.334 3.151 2.306

0.483870967741936 3.757 3.7 3.534 3.326 3.096 2.231

0.516129032258065 3.73 3.684 3.473 3.251 3.057 2.167

0.548387096774194 3.687 3.652 3.465 3.061 2.929 2.14

0.580645161290323 3.578 3.516 3.308 3.027 2.822 2.015

0.612903225806452 3.291 3.249 3.09 2.824 2.781 1.997

0.645161290322581 3.29 3.244 3.083 2.785 2.699 1.983

0.67741935483871 3.102 3.076 2.939 2.783 2.638 1.93

0.709677419354839 3.098 3.047 2.931 2.631 2.527 1.839

0.741935483870968 3.022 2.986 2.86 2.623 2.486 1.764

0.774193548387097 2.675 2.628 2.454 2.262 2.158 1.703

0.806451612903226 2.565 2.51 2.369 2.235 2.136 1.581

0.838709677419355 2.454 2.425 2.302 2.134 2.048 1.502

0.870967741935484 2.359 2.328 2.207 2.087 1.912 1.427
146

0.903225806451613 2.312 2.275 2.134 2.008 1.902 1.405

0.935483870967742 2.185 2.155 2.073 1.956 1.855 1.305

0.967741935483871 2.064 2.038 1.991 1.828 1.723 0.9281

0.1 6.7392 6.6843 6.2629 5.4412 4.9534 3.3317

Average of yearly averages: 2.31667

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run:

Output File: PAapp

Metfile: w14751.dvf

PRZM scenario: PAappleSTD_V2.txt

EXAMS environment file: pond298.exv

Chemical Name: Flutriafol

Description Variable Name Value Units Comments

Molecular weight mwt 301.3 g/mol

Henry's Law Const. henry 1.3E-11 atm-m^3/mol

Vapor Pressure vapr 3E-9 torr

Solubility sol 130 mg/L

Kd Kd mg/L

Koc Koc 322 mg/L

Photolysis half-life kdp days Half-life

Aerobic Aquatic Metabolism kbacw 100 days Halfife

Anaerobic Aquatic Metabolism kbacs 365 days Halfife

Aerobic Soil Metabolism asm 3247 days Halfife

Hydrolysis: pH 7 days Half-life

Method: CAM 2 integer See PRZM manual

Incorporation Depth: DEPI cm

Application Rate: TAPP 0.1232 kg/ha

Application Efficiency: APPEFF 0.95 fraction

Spray Drift DRFT 0.05 fraction of application rate applied to pond

Application Date Date 1-5 dd/mm or dd/mmm or dd-mm or dd-mmm

Interval 1 interval 7 days Set to 0 or delete line for single app.

app. rate 1 apprate 0.1232 kg/ha

Interval 2 interval 7 days Set to 0 or delete line for single app.

app. rate 2 apprate 0.1232 kg/ha

Interval 3 interval 7 days Set to 0 or delete line for single app.

app. rate 3 apprate 0.1232 kg/ha

Record 17:FILTRA

IPSCND 1

UPTKF

Record 18:PLVKRT

PLDKRT

FEXTRC 0.5

Flag for Index Res. Run IR EPA Pond

Flag for runoff calc. RUNOFF none none, monthly or total (average of entire run)
147

Appendix C. Aquatic Risk Quotients

Table C 1. Summarized Acute (or Instantaneous) and Chronic Aquatic Fish Risk Quotients for Flutriafol 

Treatments in Apple and Soybean Sites 1,2,3,4,5

Scenario 6,7,8 Freshwater 

Fish (Acute)

Freshwater Fish 

(Chronic)

Estuarine/Marine

Fish (Acute)

Estuarine/Marine

Fish (Chronic)

GENEEC2 and TGAI

Ground Spray to Apples <0.01 <0.1 <0.01 <0.1

Aerial Spray to Soybeans 

(14-day intervals) <0.01 <0.1 <0.01 <0.1

Aerial Spray to Soybeans

(21-day intervals) <0.01 <0.1 <0.01 <0.1

Ground Spray to Soybeans 

(14-day intervals) <0.01 <0.1 <0.01 <0.1

Ground Spray to Soybeans

(21-day intervals) <0.01 <0.1 <0.01 <0.1

AgDRIFT9and Formulation Product (TGAI and Inerts)

Ground Spray to Apples10<0.01 Not calculated

Aerial Spray to Soybeans11<0.01 Not calculated

Ground Spray to Soybeans12<0.01 Not calculated

Bold values indicate LOC exceedances:

*** RQ exceeds the Acute Risk, Acute Restricted Use, and Endangered Species LOCs; RQ > 0.5

**RQ exceeds the Acute Restricted Use and Acute Endangered Species LOCs; RQ > 0.1

* RQ exceeds the Acute Endangered Species LOC; RQ > 0.05

+ RQ exceeds the Chronic Risk and Endangered Species LOC; RQ >1

1 Detailed calculations of GENEEC2 modeling are provided in Appendix B. 

2 Acute and chronic toxicity thresholds for flutriafol TGAI are 33 mg ai/L (LC50) and 4.8 mg ai/L (NOAEC), respectively, for 

freshwater fish. 

3 Acute and chronic toxicity thresholds for flutriafol TGAI are >72.2 mg ai/L (LC50) and >11 mg ai/L (estimated NOAEC value), 

respectively, for estuarine/marine fish.

4 EECs of AgDRIFT modeling are provided in Section III.4

5 Acute toxicity thresholds for flutriafol formulation product (TGAI and inerts) are 7.9 mg form/L (LC50) and >17 mg form/L 

(estimated LC50 value), respectively, for freshwater and estuarine/marine fish.

6

Four ground applications of 0.11 lb ai/A with 7 day intervals to apples.

7 Three aerial applications of 0.06 lb ai/A with 21 day intervals to soybeans.

8 Three ground applications of 0.06 lb ai/A with 21 day intervals to soybeans. 

9 AgDRIFT estimates spray drift EECs, thus, are only compared with acute toxicity thresholds.

10 One ground application of 0.92 lb form/A to apples.

11 One aerial application of 0.5 lb form/A to soybeans.

12 One ground application of 0.5 lb form/A to soybeans.
148

Table C 2. Summarized Acute (or Instantaneous) and Chronic Aquatic Invertebrates Risk Quotients for 

Flutriafol Treatments in Apple and Soybean Sites 1,2,3,4,5

Scenario 6,7,8 Freshwater 

Inv. (Acute)

Freshwater Inv. 

(Chronic)

Estuarine/Marine

Inv. (Acute)

Estuarine/Marine

Inv. (Chronic)

GENEEC2 and TGAI

Ground Spray to Apples <0.01 <0.1 <0.01 <0.1

Aerial Spray to Soybeans 

(14-day intervals)

<0.01 <0.1 <0.01 <0.1

Aerial Spray to Soybeans

(21-day intervals) <0.01 <0.1 <0.01 <0.1

Ground Spray to Soybeans 

(14-day intervals) <0.01 <0.1 <0.01 <0.1

Ground Spray to Soybeans

(21-day intervals) <0.01 <0.1 <0.01 <0.1

AgDRIFT9and Formulation Product (TGAI and Inerts)

Ground Spray to Apples10<0.01 <0.01

Aerial Spray to Soybeans11<0.01 <0.01

Ground Spray to Soybeans12<0.01 <0.01

Bold values indicate LOC exceedances:

*** RQ exceeds the Acute Risk, Acute Restricted Use, and Endangered Species LOCs; RQ > 0.5

**RQ exceeds the Acute Restricted Use and Acute Endangered Species LOCs; RQ > 0.1

* RQ exceeds the Acute Endangered Species LOC; RQ > 0.05

+ RQ exceeds the Chronic Risk and Endangered Species LOC; RQ >1

1 Detailed calculations of GENEEC2 modeling are provided in Appendix B. 

2 Acute and chronic toxicity thresholds for flutriafol TGAI are 67 mg ai/L (EC50) and 0.31 mg ai/L (NOAEC), respectively, for 

freshwater invertebrates.

3 Acute and chronic toxicity thresholds for flutriafol TGAI are 25 mg ai/L (EC50) and 0.16 mg ai/L (estimated NOAEC value), 

respectively, for estuarine/marine invertebrates.

4 EECs of AgDRIFT modeling are provided in Section III.4

5 Acute toxicity thresholds for flutriafol formulation product (TGAI and inerts) are 7.05 mg form/L (EC50) and 2.5 mg form/L 

(estimated EC50 value), respectively, for freshwater and estuarine/marine invertebrates.

6

Four ground applications of 0.11 lb ai/A with 7 day intervals to apples.

7 Three aerial applications of 0.06 lb ai/A with 21 day intervals to soybeans.

8 Three ground applications of 0.06 lb ai/A with 21 day intervals to soybeans. 

9 AgDRIFT estimates spray drift EECs, thus, are only compared with acute toxicity thresholds.

10 One ground application of 0.92 lb form/A to apples.

11 One aerial application of 0.5 lb form/A to soybeans.

12 One ground application of 0.5 lb form/A to soybeans.
149

Table C 3. Summarized Aquatic Plant Risk Quotients for Flutriafol Treatments in Apple and Soybean 

Sites 1,2,3,4,5

Scenario 6,7,8 Listed Non-Listed

Vascular Non-Vascular Vascular Non-vascular

GENEEC2 and %AI in Product

Ground Spray to Apples 1.8* 0.32 <0.1 <0.1

Aerial Spray to Soybeans 

(14-day intervals) 0.6 <0.1 <0.1 <0.1

Aerial Spray to Soybeans

(21-day intervals) 0.5 <0.1 <0.1 <0.1

Ground Spray to Soybeans 

(14-day intervals) 0.6 <0.1 <0.1 <0.1

Ground Spray to Soybeans

(21-day intervals) 0.5 <0.1 <0.1 <0.1

PRZM/EXAMs and %AI in Product

Ground Spray to NC Apples 0.6 0.1 <0.1 <0.1

Ground Spray to OR 

Apples 0.2 <0.1 <0.1 <0.1

Ground Spray to PA Apples 0.3 <0.1 <0.1 <0.1

AgDRIFT9and Formulation Product (TGAI and Inerts)

Ground Spray to Apples10<0.1 <0.1 <0.1 <0.1

Aerial Spray to Soybeans11<0.1 <0.1 <0.1 <0.1

Ground Spray to Soybeans12<0.1 <0.1 <0.1 <0.1

Bold values indicate LOC exceedances:

* RQ exceeds the Listed Plant LOCs; RQ > 1.0

**RQ exceeds the Non-listed Plant LOCs; RQ > 1.0

1 Detailed calculations of GENEEC2 and PRZM/EXAMs modeling are provided in Appendix B. 

2 EECs as a result of AGDRIFT modeling are provided in the Measures of Exposure section.

3 The non-listed toxicity threshold (EC50) for the %AI in the formulation product is 0.78 mg ai/L for aquatic vascular plants; 

while the listed toxicity threshold (surrogate EC05) for the %AI in the product is 0.018 mg ai/L. NOAEC <0.13 mg ai/L. 

4 The non-listed toxicity threshold (EC50) is 0.46 mg ai/L for aquatic non-vascular plants; while the listed toxicity threshold 

(NOAEC) is 0.1 mg ai/L. 

5 Non-listed toxicity thresholds for flutriafol formulation product (TGAI and inerts) are 6.6 mg form/L (LC50) and 3.8 mg 

form/L (estimated LC50 value), respectively, for vascular and nonvascular aquatic plants.

6 Listed toxicity thresholds for flutriafol formulation product (TGAI and inerts) are 0.15 mg form/L (LC50) and 0.84 mg 

form/L (estimated LC50 value), respectively, for vascular and nonvascular aquatic plants.

6

Four ground applications of 0.11 lb ai/A with 7 day intervals to apples.

7 Three aerial applications of 0.06 lb ai/A with 21 day intervals to soybeans.

8 Three ground applications of 0.06 lb ai/A with 21 day intervals to soybeans. 

9 AgDRIFT estimates spray drift EECs, thus, are only compared with acute toxicity thresholds.

10 One ground application of 0.92 lb form/A to apples.

11 One aerial application of 0.5 lb form/A to soybeans.

12 One ground application of 0.5 lb form/A to soybeans.
150

Appendix D. T-REX (Terrestrial Exposure Model for Birds and Mammals) 

Input and Output

This appendix describes how the model, T-REX version 1.2.3, estimates the following: (1) residue 

concentrations on selected food items (mg/kg-dietary item); (2) dose-based EECs (mg/kg-bw) 

from dietary concentrations on selected food items; (3) adjusted toxicity values; and risk quotients 

for birds and mammals.

(1) Calculation of dietary concentrations on selected food items

T-REX calculates the pesticide residue concentrations on each selected food item on a daily

interval for one year. When multiple applications are modeled, residue concentrations resulting 

from the final application and remaining residue from previous applications are summed. The 

maximum concentration calculated out of the 365 days is returned as the EEC used to estimate 

potential risk to birds and mammals as described below. Dissipation of a chemical applied to 

foliar surfaces for single or multiple applications is calculated assuming a first order decay rate 

from the following first order rate equation:

Ct = C0e

-kt

or in log form:

ln(Ct) = ln(C0)(-kT)

Where:

Ct = concentration, parts per million (mg/kg), at time T.

C0 = concentration (mg/kg), present initially (on day zero) on the surface of selected food items. C0 is 

calculated by multiplying the application rate, in pounds active ingredient per acre, by 240 for 

short grass, 110 for tall grass, and 135 for broad-leafed plants/small insects and 15 for 

fruits/pods/large insects for upper bound residue levels. Mean residue levels are derived by 

multiplying the application rate by 85 for short grass, 36 for tall grass, and 45 for broad-leafed 

plants/small insects and 7 for fruits/pods/seeds/large insects. Residue levels are based on work by

Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994). Additional applications are 

converted from pounds active ingredient per acre to ppm on the plant surface and the additional 

mass added to the mass of the chemical still present on the surfaces on the day of application. 

k = Exponential rate constant = ln 2 ÷ foliar dissipation half-life. When scientifically valid, 

statistically robust data are not available, EFED recommends the using a default foliar dissipation 

half-life value of 35 days. The use of the 35-day half-life is based on the highest reported value 

(36.9 days), as reported by Willis and McDowell (1987).

t = time, in days, since the start of the simulation. The initial application is on day 0. The simulation 

is designed to run for 365 days.

The dietary concentrations estimated using the above methodology may be used directly to 

calculate risk quotients, but may also be used to calculate dose-based EECs (mg/kg-bw) for 

various size classes of mammals and birds as described below. 
151

(2) Calculating EEC Equivalent Doses based on Estimated Dietary Concentrations on 

Selected Bird and Mammal Food Items

EECs (mg/kg-bw) for various size classes of mammals and birds may be calculated based on the 

dietary residue concentrations derived using the equations presented above. To allow for this 

type of analysis, the EECs and toxicity values are adjusted based on food intake and body weight 

differences so that they are comparable for a given weight class of animal. The size classes 

assessed are small (20-gram), medium (100-gram), and large (1000-gram) birds, and small (15-

gram), medium (35-gram), and large (1000-gram) mammals. Equations used to calculate food 

intake (grams/day) and to adjust toxicity values for dose-based risk quotients are presented 

below. 

Calculating Food Intake for Different Size Classes of Birds and Mammals: 

Daily food intake (g/day) is assumed to correlate with body weight using the following 

empirically derived equation (U.S. EPA, 1993): 

Avian consumption

F

BW

W





0 648

1

0 651

. *

( )

.

where:

F = food intake in grams of fresh weight per day (g/day)

BW = body mass of animal (g)

W = mass fraction of water in the food (EFED value = 0.8 for birds and 

herbivorous mammals, 0.1 for granivorous mammals)

Based on this equation, a 20-gram bird would consume 22.8 grams of food daily (114% of its 

body weight), a 100-gram bird would consume 65 grams of food daily (65% of its body weight 

daily), and 1000-gram bird would consume 290 grams of food daily (29% of its body weight). 

These data, together with the residue concentrations (mg/kg-food item) on selected food items 

calculated from the Kenaga nomogram, are used to estimate the dose (mg/kg-bw) of residue 

consumed by the three size classes of birds as discussed below. Using a 20-gram bird as an 

example, a dietary concentration of 100 mg/kg-diet (ppm) x 1.14 kg diet/kg bw (114%) would 

result in an equivalent dose-based EEC of 114 mg/kg-bw. T-REX calculates food intake based 

on dry weight and wet weight of food items. The dose-based assessment uses the wet weight 

food consumption values by assuming that dietary items are 80% water by weight. However, if 

dietary items of a species being assessed are known, then a refined dose-based EEC can be 

calculated using appropriate water fractions of the food items. 

A similar relationship between body weight and food intake has been derived for mammals (U.S. 

EPA 1993): 

Mammalian food consumption (g/day)
152

F

BW

W





0 621

1

0 564

. *

( )

.

where:

F = food intake in grams of fresh weight per day (g/day)

BW = body mass of animal (g)

W = mass fraction of water in the food (EFED value = 0.8 for birds and 

herbivorous mammals, 0.1 for granivorous mammals)

The scaling factors result in a percent body weight consumed presented in the following table for 

each weight class of mammal. These values are used in the same manner described for birds to 

calculate dose-based EECs (mg/kg-bw). Note the difference in food intake of granivores 

compared with herbivores and insectivores. This is caused by the difference in the assumed 

mass fraction of water in their diets. 

Organism and 

body weight

Food intake

(g day-1)

a

Percent body weight 

consumed (day-1)

a

15 g 14.3 / 3.2 95 / 21

35 g 23 / 5.1 66 / 15

1000 g 150 / 34 15 / 3

a The first number in this column is specific to herbivores/insectivores. The second number is for granivores. These groups have 

markedly different consumption requirements.

T-REX calculates food intake based on dry weight and wet weight of food items (wet weight is 

used for RQ calculations). The dose-based assessment uses the wet weight food consumption 

values by assuming that dietary items are 80% water by weight (10% for granivores). However, 

if dietary items of a species being assessed are known, then a refined dose-based EEC can be 

calculated using appropriate water fractions of the food items. 

(3) Calculating Adjusted Toxicity Values

The dose-based EECs (mg/kg-bw) derived above are compared with LD50 or NOAEL (mg/kgbw) values from acceptable or supplemental toxicity studies that are adjusted for the size of the 

animal tested compared with the size of the animal being assessed (e.g., 20-gram bird). These 

exposure values are presented as mass of pesticide consumed per kg body weight of the animal 

being assessed (mg/kg-bw). EECs and toxicity values are relative to the animal’s body weight 

(mg residue/kg bw) because consumption of the same mass of pesticide residue results in a 

higher body burden in smaller animals compared with larger animals. For birds, only acute 

values (LD50s) are adjusted because dose-based risk quotients are not calculated for the chronic 

risk estimation. Adjusted mammalian LD50s and reproduction NOAELs (mg/kg-bw) are used to 

calculate dose-based acute and chronic risk quotients for 15-, 35-, and 1000-gram mammals. 

The following equations are used for the adjustment (U.S. EPA 1993):

Adjusted avian LD50: 
153

Adj LD LD

AW

TW

x

.

( )

50 50

1

















where:

Adj. LD50 = adjusted LD50 (mg/kg-bw) calculated by the equation

LD50 = endpoint reported from bird study (mg/kg-bw)

TW = body weight of tested animal (178g bobwhite; 1580g mallard; 350g rat)

AW = body weight of assessed animal (avian: 20g, 100g, and 1000g)

x = Mineau scaling factor for birds; EFED default 1.15

Adjusted mammalian NOAELs and LD50s (note that the same equation is used to adjust 

the NOAEL): 

Adj NOAEL or LD NOAEL or LD

TW

AW .

( . )

50 50

0 25















where:

Adj. NOAEL or LD50 = adjusted NOAEL or LD50 (mg/kg-bw)

NOAEL or LD50 = endpoint reported from bird study (mg/kg-bw)

TW = body weight of tested animal (350g rat)

AW = body weight of assessed animal (15g, 35g, 1000g)

(4) Calculating Risk Quotients

Two types of risk quotients are calculated by T-REX based on the estimated dietary residue 

concentrations determined from the Kenaga nomogram: (1) dietary based RQs; and (2) dose 

based RQs. These RQs are not equivalent. Dietary risk quotients are calculated by directly 

comparing the concentration of a pesticide administered (or estimated to be administered) to 

experimental animals in the diet in a toxicity study to the concentration estimated to be on 

selected food items. These risk quotients do not account for the fact that smaller-sized animals 

need to consume more food relative to their body weight than larger animals or those differential 

amounts of food are consumed depending on the water content and nutritive value of the food. 

The dose-based risk quotients do account for these factors. The dose-based RQs incorporate the 

ingestion rate-adjusted exposure from the various food items to the different weight classes of 

birds and the weight class-scaled toxicity endpoints. Formulas presented below are used to 

calculate dose-based and dietary based risk quotients: 
154

Duration Dose or

Dietary RQ

Surrogate 

Organism

Equation

Acute Dose-based Birds and 

mammals

Acute Daily Exposure (mg/kg-bw) / adjusted LD50 (mg/kgbw)

Dietary-based Birds Kenaga EEC (mg/kg-food item) / LC50 (mg/kg-diet)

Chronic Dietary-based Birds and 

mammals

EEC (mg/kg-food item) / NOAEC (mg/kg-diet)

Dose-based Mammals only EEC (mg/kg-bw) / Adjusted NOAEL (mg/kg-bw)

These risk quotients are compared to the Agency’s LOCs to determine if risk is greater than 

EFED’s concern level.

Soybean Use – Upper Bound (3 x 0.06 lb ai/A x 21D Interval)

Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Flutriafol

Use: Soybeans

Formulation: TopGuard

Application Rate: 0.06 lbs ai/A

Half-life: 35 days

Application Interval: 21 days

Maximum # Apps./Year: 3 applications

Length of Simulation: 1 year

Endpoints

Avian

Partridge LD50 (mg/kg-bw) 616.00

Mallard duck LC50 (mg/kg-diet) 4062.00

Mallard duck NOAEL(mg/kg-bw) 0.00

Mallard duck NOAEC (mg/kg-diet) 39.20

Mammals

Mouse LD50 (mg/kg-bw) 179.00

LC50 (mg/kg-diet) 0.00

Rat NOAEL (mg/kg-bw) 20.60

Rat NOAEC (mg/kg-diet) 240.00

Dietary-Based EECs 

Food Items Upper Bound EEC

(mg ai/kg)

Mean EEC

(mg ai/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

30.2

13.8

17.0

1.9

10.7

4.5

5.7

0.9
155

AVIAN EECs and ADJUSTED LD50s

Avian Class Body Weight 

(g)

Ingestion 

(Fdry)

(g bw/day)

Ingestion 

(Fwet)

(g/day)

% body wgt

consumed

FI

(kg-diet/day)

Small 20 5 23 114 2.28E-02

Mid 100 13 65 65 6.49E-02

Large 1000 58 291 29 2.91E-01

Avian Body 

Weight (g)

Adjusted LD50

(mg/kg-bw)

20 388.79

100 494.95

1000 699.13

Dose-based EECs (mg/kg-bw)

Food items

Avian Classes and Body Weights

small mid large

20 g 100 g 1000 g

Upper Bound EEC (mg/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

34.4 19.6 8.8

15.8 9.0 4.0

19.3 11.0 4.9

2.2 1.2 0.6

Mean EEC (mg/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

12.2 7.0 3.1

5.2 2.9 1.3

6.5 3.7 1.6

1.0 0.6 0.3

MAMMALIAN EECs and ADJUSTED LD50s

Mammalian

Class

Body

Weight

Ingestion 

(Fdry)

(g bwt/day)

Ingestion 

(Fwet)

(g/day)

% body wgt

consumed

FI

(kg-diet/day)

Herbivores/

insectivores

15 3 14 95 1.43E-02

35 5 23 66 2.31E-02

1000 31 153 15 1.53E-01

Granivores

15 3 3 21 3.18E-03

35 5 5 15 5.13E-03

1000 31 34 3 3.40E-02
156

Mammalian

Class

Body 

Weight

Adjusted

LD50

Adjusted

NOAEL

Herbivores/

insectivores

15 192.35 45.28

35 155.63 36.63

1000 67.31 15.84

Granivores

15 192.35 45.28

35 155.63 36.63

1000 67.31 15.84

Dose-based EECs 

(mg/kg-bw)

Mammalian Classes and Body Weight

Herbivores and Insectivores Granivores

15 g 35 g 1000 g 15 g 35 g 1000 g

Upper Bound EECs (mg ai/kg)

Short Grass 28.76 19.88 4.61

Tall Grass 13.18 9.11 2.11

Broadleaf plants and small insects 16.18 11.18 2.59

Fruits/pods/seeds/large insects 1.80 1.24 0.29 0.40 0.28 0.06

Mean EECs (mg ai/kg)

Short Grass 10.15 7.05 1.60

Tall Grass 4.30 2.99 0.68

Broadleaf plants and small insects 5.37 3.73 0.85

Fruits/pods/seeds/large insects 0.84 0.58 0.13 0.18 0.13 0.03

RESULTS – Upper Bound EECs and RQs

Table D1. Upper Bound Kenaga, Acute Avian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

20 388.79 34.36 0.09 15.75 0.04 19.33 0.05 2.15 0.01

100 494.95 19.59 0.04 8.98 0.02 11.02 0.02 1.22 0.00

1000 699.13 8.77 0.01 4.02 0.01 4.93 0.01 0.55 0.00

Bold value indicates LOC exceedance

Table D2. Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

LC50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

4062 30.17 0.01 13.83 0.00 16.97 0.00 1.89 0.00

Size class not used for dietary risk quotients 

Bold value indicates LOC exceedance
157

Table D3. Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

39 30.17 0.77 13.83 0.35 16.97 0.43 1.89 0.05

Size class not used for dietary risk quotients

Bold values indicate LOC exceedances

Table D4. Upper Bound Kenaga, Acute Mammalian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 192.35 28.76 0.15 13.18 0.07 16.18 0.08 1.80 0.01 0.40 0.00

35 155.63 19.88 0.13 9.11 0.06 11.18 0.07 1.24 0.01 0.28 0.00

1000 67.31 4.61 0.07 2.11 0.03 2.59 0.04 0.29 0.00 0.06 0.00

Table D5. Upper Bound Kenaga, Chronic Mammalian Dietary Based Risk 

Quotients (3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

240 30.17 0.13 13.83 0.06 16.97 0.07 1.89 0.01

Size class not used for dietary risk quotients 

Table D6. Upper Bound Kenaga, Chronic Mammalian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

Size Class

(grams)

Adjusted 

NOAEL

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 45.28 28.76 0.64 13.18 0.29 16.18 0.36 1.80 0.04 0.40 0.01

35 36.63 19.88 0.54 9.11 0.25 11.18 0.31 1.24 0.03 0.28 0.01

1000 15.84 4.61 0.29 2.11 0.13 2.59 0.16 0.29 0.02 0.06 0.00

Bold values indicate LOC exceedances
158

Soybean Use – Mean EECs and RQs (3 x 0.06 lb ai/A x 21 D intervals)

Table D7. Mean Kenaga, Acute Avian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large 

Insects

EEC RQ EEC RQ EEC RQ EEC RQ

20 388.79 12.17 0.031 5.15 0.013 6.44 0.017 1.00 0.003

100 494.95 6.94 0.014 2.94 0.006 3.67 0.007 0.57 0.001

1000 699.13 3.11 0.004 1.32 0.002 1.64 0.002 0.26 0.000

Table D8. Mean Kenaga, Subacute Avian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

LC50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

4062 10.68 0.003 4.53 0.001 5.66 0.001 0.88 0.000

Size class not used for dietary risk quotients 

Table D9. Mean Kenaga, Chronic Avian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large 

Insects

EEC RQ EEC RQ EEC RQ EEC RQ

39 10.68 0.273 4.53 0.115 5.66 0.144 0.88 0.022

Size class not used for dietary risk quotients

Bold value indicates LOC exceedance
159

Table D10. Mean Kenaga, Acute Mammalian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large 

Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 192.35 10.19 0.053 4.31 0.022 5.39 0.028 0.84 0.004 0.19 0.00

35 155.63 7.04 0.045 2.98 0.019 3.73 0.024 0.58 0.004 0.13 0.00

1000 67.31 1.63 0.024 0.69 0.010 0.86 0.013 0.13 0.002 0.03 0.00

Table D11. Mean Kenaga, Chronic Mammalian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

240 10.68 0.045 4.53 0.019 5.66 0.024 0.88 0.004

Size class not used for dietary risk quotients 

Table D12. Mean Kenaga, Chronic Mammalian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 21 Day Intervals)

Size Class

(grams)

Adjusted 

NOAEL

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large 

Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 45.28 10.19 0.225 4.31 0.095 5.39 0.119 0.84 0.019 0.19 0.00

35 36.63 7.04 0.192 2.98 0.081 3.73 0.102 0.58 0.016 0.13 0.00

1000 15.84 1.63 0.103 0.69 0.044 0.86 0.055 0.13 0.008 0.03 0.00
160

Soybean Use – Upper Bound (3 x 0.06 lb ai/A x 14D Interval)

Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Flutriafol

Use: Soybeans

Formulation: TopGuard

Application Rate: 0.06 lbs ai/A

Half-life: 35 days

Application Interval: 14 days

Maximum # Apps./Year: 3 applications

Length of Simulation: 1 year

Endpoints

Avian

Partridge LD50 (mg/kg-bw) 616.00

Mallard duck LC50 (mg/kg-diet) 4062.00

Mallard duck NOAEL(mg/kg-bw) 0.00

Mallard duck NOAEC (mg/kg-diet) 39.20

Mammals

Mouse LD50 (mg/kg-bw) 179.00

LC50 (mg/kg-diet) 0.00

Rat NOAEL (mg/kg-bw) 20.60

Rat NOAEC (mg/kg-diet) 240.00

Dietary-Based EECs 

Food Items Upper Bound EEC

(mg ai/kg)

Mean EEC

(mg ai/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

33.58

15.39

18.89

2.10

11.89

5.04

6.30

0.98

AVIAN EECs and ADJUSTED LD50s

Avian Class Body Weight 

(g)

Ingestion 

(Fdry)

(g bw/day)

Ingestion 

(Fwet)

(g/day)

% body wgt

consumed

FI

(kg-diet/day)

Small 20 5 23 114 2.28E-02

Mid 100 13 65 65 6.49E-02

Large 1000 58 291 29 2.91E-01

Avian Body 

Weight (g)

Adjusted LD50

(mg/kg-bw)

20 388.79

100 494.95

1000 699.13
161

Dose-based EECs (mg/kg-bw)

Food items

Avian Classes and Body Weights

small mid large

20 g 100 g 1000 g

Upper Bound EEC (mg/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

38.25 21.81 9.77

17.53 10.00 4.48

21.51 12.27 5.49

2.39 1.36 0.61

Mean EEC (mg/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

13.56 7.73 3.45

5.74 3.27 1.46

7.18 4.09 1.83

1.12 0.64 0.28

MAMMALIAN EECs and ADJUSTED LD50s

Mammalian

Class

Body

Weight

Ingestion 

(Fdry)

(g bwt/day)

Ingestion 

(Fwet)

(g/day)

% body wgt

consumed

FI

(kg-diet/day)

Herbivores/

insectivores

15 3 14 95 1.43E-02

35 5 23 66 2.31E-02

1000 31 153 15 1.53E-01

Granivores

15 3 3 21 3.18E-03

35 5 5 15 5.13E-03

1000 31 34 3 3.40E-02

Mammalian

Class

Body 

Weight

Adjusted

LD50

Adjusted

NOAEL

Herbivores/

insectivores

15 192.35 45.28

35 155.63 36.63

1000 67.31 15.84

Granivores

15 192.35 45.28

35 155.63 36.63

1000 67.31 15.84
162

Dose-based EECs 

(mg/kg-bw)

Mammalian Classes and Body Weight

Herbivores and Insectivores Granivores

15 g 35 g 1000 g 15 g 35 g 1000 g

Upper Bound EECs (mg ai/kg)

Short Grass 32.02 22.13 5.13

Tall Grass 14.68 10.14 2.35

Broadleaf plants and small insects 18.01 12.45 2.89

Fruits/pods/seeds/large insects 2.00 1.38 0.32 0.44 0.31 0.07

Mean EECs (mg ai/kg)

Short Grass 11.30 7.85 1.78

Tall Grass 4.79 3.32 0.76

Broadleaf plants and small insects 5.98 4.16 0.94

Fruits/pods/seeds/large insects 0.93 0.65 0.15 0.21 0.15 0.03

RESULTS – Upper Bound EECs and RQs

Table D1. Upper Bound Kenaga, Acute Avian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

20 388.79 38.3 0.1 17.5 0.05 21.5 0.06 2.4 0.01

100 494.95 21.8 0.05 10 0.02 12.3 0.03 1.4 0.00

1000 699.13 9.8 0.01 4.5 0.01 5.5 0.01 0.6 0.00

Bold value indicates LOC exceedance

Table D2. Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

LC50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

4062 33.6 0.01 15.4 0.00 18.9 0.00 2.1 0.00

Size class not used for dietary risk quotients; Bold value indicates LOC exceedance

Table D3. Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

39 33.6 0.86 15.4 0.39 18.9 0.48 2.1 0.05

Size class not used for dietary risk quotients; Bold values indicate LOC exceedances
163

Table D4. Upper Bound Kenaga, Acute Mammalian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 192.35 32 0.17 14.5 0.08 18 0.09 2 0.01 0.4 0.00

35 155.63 22.1 0.14 10.1 0.07 12.5 0.08 1.4 0.01 0.3 0.00

1000 67.31 5.1 0.08 2.4 0.03 2.9 0.04 0.32 0.00 0.07 0.00

Table D5. Upper Bound Kenaga, Chronic Mammalian Dietary Based Risk 

Quotients (3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

240 33.6 0.14 15.4 0.06 18.9 0.08 2.1 0.01

Size class not used for dietary risk quotients 

Table D6. Upper Bound Kenaga, Chronic Mammalian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

Size Class

(grams)

Adjusted 

NOAEL

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 45.28 32.0 0.08 14.7 0.04 18 0.05 2 0.01 0.44 0.00

35 36.63 22.1 0.07 10.1 0.03 12.5 0.04 1.4 0.00 0.31 0.00

1000 15.84 5.1 0.04 2.4 0.02 2.9 0.02 0.32 0.00 0.07 0.00

Bold values indicate LOC exceedances
164

Soybean Use – Mean EECs and RQs (3 x 0.06 lb ai/A x 14D Intervals)

Table D7. Mean Kenaga, Acute Avian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large 

Insects

EEC RQ EEC RQ EEC RQ EEC RQ

20 388.79 13.6 0.04 5.7 0.02 7.2 0.02 1.1 0.00

100 494.95 7.7 0.02 3.3 0.01 4.1 0.01 0.64 0.00

1000 699.13 3.5 0.01 1.5 0.00 1.8 0.00 0.28 0.00

Table D8. Mean Kenaga, Subacute Avian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

LC50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

4062 11.9 0.00 5.0 0.00 6.3 0.00 0.98 0.00

Size class not used for dietary risk quotients 

Table D9. Mean Kenaga, Chronic Avian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large 

Insects

EEC RQ EEC RQ EEC RQ EEC RQ

39 11.9 0.3 5.0 0.13 6.3 0.16 0.98 0.02

Size class not used for dietary risk quotients

Bold value indicates LOC exceedance
165

Table D10. Mean Kenaga, Acute Mammalian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large 

Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 192.35 11.3 0.06 4.8 0.02 6 0.03 0.9 0.00 0.2 0.00

35 155.63 7.8 0.05 3.3 0.02 4.2 0.03 0.7 0.00 0.14 0.00

1000 67.31 1.8 0.03 0.8 0.01 0.96 0.01 0.2 0.00 0.03 0.00

Table D11. Mean Kenaga, Chronic Mammalian Dietary Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

240 11.9 0.05 5.0 0.02 6.3 0.03 0.98 0.00

Size class not used for dietary risk quotients 

Table D12. Mean Kenaga, Chronic Mammalian Dose-Based Risk Quotients

(3 Applications @ 0.06 lb ai/A with 14 Day Intervals)

Size Class

(grams)

Adjusted 

NOAEL

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large 

Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 45.28 11.3 0.25 4.8 0.1 6 0.13 0.9 0.02 0.2 0.00

35 36.63 7.9 0.21 3.3 0.09 4.2 0.11 0.7 0.02 0.15 0.00

1000 15.84 1.8 0.11 0.8 0.05 0.9 0.06 0.2 0.01 0.03 0.00
166

Apple Use

Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Flutriafol

Use: Apples

Formulation: TopGuard

Application Rate: 0.11 lbs ai/A

Half-life: 35 days

Application Interval: 7 days

Maximum # Apps./Year: 4 applications

Length of Simulation: 1 year

Endpoints

Avian

Partridge LD50 (mg/kg-bw) 616.00

Mallard duck LC50 (mg/kg-diet) 4062.00

Mallard duck NOAEL(mg/kg-bw) 0.00

Mallard duck NOAEC (mg/kg-diet) 39.20

Mammals

Mouse LD50 (mg/kg-bw) 179.00

LC50 (mg/kg-diet) 0.00

Rat NOAEL (mg/kg-bw) 20.60

Rat NOAEC (mg/kg-diet) 240.00

Dietary-Based EECs 

Food Items Upper Bound EEC

(mg ai/kg)

Mean EEC

(mg ai/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

86.81

39.79

48.83

5.43

30.74

13.02

16.28

2.53

AVIAN EECs and ADJUSTED LD50s

Avian Class Body Weight 

(g)

Ingestion 

(Fdry)

(g bw/day)

Ingestion 

(Fwet)

(g/day)

% body wgt

consumed

FI

(kg-diet/day)

Small 20 5 23 114 2.28E-02

Mid 100 13 65 65 6.49E-02

Large 1000 58 291 29 2.91E-01

Avian Body 

Weight (g)

Adjusted LD50

(mg/kg-bw)

20 388.79

100 494.95

1000 699.13
167

Dose-based EECs (mg/kg-bw)

Food items

Avian Classes and Body Weights

small mid large

20 g 100 g 1000 g

Upper Bound EEC (mg/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

98.87 56.38 25.24

45.31 25.84 11.57

55.61 31.71 14.20

6.18 3.52 1.58

Mean EEC (mg/kg)

Short Grass

Tall Grass

Sm. Insects, Broadleaf Plants

Lg. Insects, Fruits, Pods

35.01 19.97 8.94

14.83 8.46 3.79

18.54 10.57 4.73

2.88 1.64 0.74

MAMMALIAN EECs and ADJUSTED LD50s

Mammalian

Class

Body

Weight

Ingestion 

(Fdry)

(g bwt/day)

Ingestion 

(Fwet)

(g/day)

% body wgt

consumed

FI

(kg-diet/day)

Herbivores/

insectivores

15 3 14 95 1.43E-02

35 5 23 66 2.31E-02

1000 31 153 15 1.53E-01

Granivores

15 3 3 21 3.18E-03

35 5 5 15 5.13E-03

1000 31 34 3 3.40E-02

Mammalian

Class

Body 

Weight

Adjusted

LD50

Adjusted

NOAEL

Herbivores/

insectivores

15 192.35 45.28

35 155.63 36.63

1000 67.31 15.84

Granivores

15 192.35 45.28

35 155.63 36.63

1000 67.31 15.84
168

Dose-based EECs 

(mg/kg-bw)

Mammalian Classes and Body Weight

Herbivores and Insectivores Granivores

15 g 35 g 1000 g 15 g 35 g 1000 g

Upper Bound EECs (mg ai/kg)

Short Grass 82.76 57.20 13.26

Tall Grass 37.93 26.22 6.08

Broadleaf plants and small insects 46.55 32.18 7.46

Fruits/pods/seeds/large insects 5.17 3.58 0.83 1.15 0.79 0.18

Mean EECs (mg ai/kg)

Short Grass 29.31 20.26 4.70

Tall Grass 12.41 8.58 1.99

Broadleaf plants and small insects 15.52 10.73 2.49

Fruits/pods/seeds/large insects 2.41 1.67 0.39 0.54 0.37 0.09

RESULTS– Upper Bound EECs and RQs

Table D 13. Upper Bound Kenaga, Acute Avian Dose-Based Risk Quotients

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

20 388.79 98.87 0.25 45.31 0.12 55.61 0.14 6.18 0.02

100 494.95 56.38 0.11 25.84 0.05 31.71 0.06 3.52 0.01

1000 699.13 25.24 0.04 11.57 0.02 14.20 0.02 1.58 0.00

Bold value indicates LOC exceedance

Table D 14. Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients 

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

LC50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

4062 86.81 0.02 39.79 0.01 48.83 0.01 5.43 0.00

Size class not used for dietary risk quotients 

Bold value indicates LOC exceedance
169

Table D 15. Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients 

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

39 86.81 2.21 39.79 1.01 48.83 1.25 5.43 0.14

Size class not used for dietary risk quotients

Bold values indicate LOC exceedances

Table D 16. Upper Bound Kenaga, Acute Mammalian Dose-Based Risk Quotients

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 192.35 82.76 0.43 37.93 0.20 46.55 0.24 5.17 0.03 1.15 0.01

35 155.63 57.20 0.37 26.22 0.17 32.18 0.21 3.58 0.02 0.79 0.01

1000 67.31 13.26 0.20 6.08 0.09 7.46 0.11 0.83 0.01 0.18 0.00

Table D 17. Upper Bound Kenaga, Chronic Mammalian Dietary Based Risk 

Quotients (4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

240 86.81 0.36 39.79 0.17 48.83 0.20 5.43 0.02

Size class not used for dietary risk quotients 
170

Table D 18. Upper Bound Kenaga, Chronic Mammalian Dose-Based Risk Quotients

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

Size Class

(grams)

Adjusted 

NOAEL

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 45.28 82.76 1.83 37.93 0.84 46.55 1.03 5.17 0.11 1.15 0.03

35 36.63 57.20 1.56 26.22 0.72 32.18 0.88 3.58 0.10 0.79 0.02

1000 15.84 13.26 0.84 6.08 0.38 7.46 0.47 0.83 0.05 0.18 0.01

Bold values indicate LOC exceedances

Apple Use – Mean EECs and RQs

Table D 19. Mean Kenaga, Acute Avian Dose-Based Risk Quotients 

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large 

Insects

EEC RQ EEC RQ EEC RQ EEC RQ

20 388.79 35.01 0.090 14.83 0.038 18.54 0.048 2.88 0.007

100 494.95 19.97 0.040 8.46 0.017 10.57 0.021 1.64 0.003

1000 699.13 8.94 0.013 3.79 0.005 4.73 0.007 0.74 0.001

Table D 20. Mean Kenaga, Subacute Avian Dietary Based Risk Quotients 

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

LC50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

4062 30.74 0.008 13.02 0.003 16.28 0.004 2.53 0.001

Size class not used for dietary risk quotients 
171

Table D 21. Mean Kenaga, Chronic Avian Dietary Based Risk Quotients 

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large 

Insects

EEC RQ EEC RQ EEC RQ EEC RQ

39 30.74 0.784 13.02 0.332 16.28 0.415 2.53 0.065

Size class not used for dietary risk quotients

Bold value indicates LOC exceedance

Table D 22. Mean Kenaga, Acute Mammalian Dose-Based Risk Quotients 

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large 

Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 192.35 29.31 0.152 12.41 0.065 15.52 0.081 2.41 0.013 0.54 0.00

35 155.63 20.26 0.130 8.58 0.055 10.73 0.069 1.67 0.011 0.37 0.00

1000 67.31 4.70 0.070 1.99 0.030 2.49 0.037 0.39 0.006 0.09 0.00

Table D 23. Mean Kenaga, Chronic Mammalian Dietary Based Risk Quotients

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

NOAEC 

(mg/kg-diet)

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small 

Insects

Fruits/Pods/

Seeds/

Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

240 30.74 0.128 13.02 0.054 16.28 0.068 2.53 0.011

Size class not used for dietary risk quotients 

Table D 24. Mean Kenaga, Chronic Mammalian Dose-Based Risk Quotients 

(4 Applications @ 0.11 lb ai/A with 7 Day Intervals)

Size Class

(grams)

Adjusted 

NOAEL

EECs and RQs

Short Grass Tall Grass

Broadleaf 

Plants/

Small Insects

Fruits/Pods/

Seeds/

Large 

Insects

Granivores

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 45.28 29.31 0.647 12.41 0.274 15.52 0.343 2.41 0.053 0.54 0.01

35 36.63 20.26 0.553 8.58 0.234 10.73 0.293 1.67 0.046 0.37 0.01

1000 15.84 4.70 0.296 1.99 0.126 2.49 0.157 0.39 0.024 0.09 0.01
172

Appendix E. Terrestrial Plants Exposure Modeling and Results (TerrPlant v 

1.2.2)

1. Ground Application of 0.06 lbs ai/A to Soybeans

Table E1. Chemical Identity.

Chemical Name Flutriafol 125 g/l SC

PC code 128940

Use Soybeans

Application Method Ground

Application Form liquid 

Solubility in Water (ppm) 130 mg/L

Table E2. Input parameters used to derive EECs.

Input Parameter Symbol Value Units

Application Rate A 0.06 lbs ai/A

Incorporation I 1 none

Runoff Fraction R 0.05 none

Drift Fraction D 0.01 none

Table E3. EECs for Flutriafol 125 g/l SC. Units in lbs ai/A.

Description Equation EEC

Runoff to dry areas (A/I)*R 0.003

Runoff to semi-aquatic areas (A/I)*R*10 0.03

Spray drift A*D 0.0006

Total for dry areas ((A/I)*R)+(A*D) 0.0036

Total for semi-aquatic areas ((A/I)*R*10)+(A*D) 0.0306

Table E4. Plant survival and growth data used for RQ derivation. Units are in lbs ai/A.

Seedling Emergence Vegetative Vigor

Plant type EC25 NOAEC EC25 NOAEC 

Monocot >0.12 >0.12 >0.12 >0.12

Dicot >0.12 >0.12 >0.12 >0.12

Table E5. RQ values for plants in dry and semi-aquatic areas exposed to Flutriafol 125 g/l SC through 

runoff and/or spray drift.*

Plant Type Listed Status Dry Semi-Aquatic Spray Drift

Monocot non-listed <0.1 <0.26 <0.1

Monocot listed <0.1 <0.26 <0.1

Dicot non-listed <0.1 <0.26 <0.1

Dicot listed <0.1 <0.26 <0.1

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.

INC - inconclusive
173

2. Aerial Application of 0.06 lbs ai/A to Soybeans

Table E6. Chemical Identity.

Chemical Name Flutriafol 125 g/l SC

PC code 128940

Use Soybeans

Application Method Aerial

Application Form liquid 

Solubility in Water (ppm) 130 mg/L

Table E7. Input parameters used to derive EECs.

Input Parameter Symbol Value Units

Application Rate A 0.06 Lbs ai/A

Incorporation I 1 none

Runoff Fraction R 0.05 none

Drift Fraction D 0.05 none

Table E8. EECs for Flutriafol 125 g/l SC. Units in y.

Description Equation EEC

Runoff to dry areas (A/I)*R 0.003

Runoff to semi-aquatic areas (A/I)*R*10 0.03

Spray drift A*D 0.003

Total for dry areas ((A/I)*R)+(A*D) 0.006

Total for semi-aquatic areas ((A/I)*R*10)+(A*D) 0.033

Table E9. Plant survival and growth data used for RQ derivation. Units are in Lbs ai/A.

Seedling Emergence Vegetative Vigor

Plant type EC25 NOAEC EC25 NOAEC 

Monocot >0.12 >0.12 >0.12 >0.12

Dicot >0.12 >0.12 >0.12 >0.12

Table E10. RQ values for plants in dry and semi-aquatic areas exposed to Flutriafol 125 g/l SC 

through runoff and/or spray drift.*

Plant Type Listed Status Dry Semi-Aquatic Spray Drift

Monocot non-listed <0.1 <0.28 <0.1

Monocot listed <0.1 <0.28 <0.1

Dicot non-listed <0.1 <0.28 <0.1

Dicot listed <0.1 <0.28 <0.1

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.

INC - inconclusive
174

3. Ground Application of 0.11 lbs ai/A to Apples

Table E11. Chemical Identity.

Chemical Name Flutriafol 125 g/l SC

PC code 128940

Use Apples

Application Method Ground

Application Form liquid 

Solubility in Water (mg/L) 130 mg/L

Table E12. Input parameters used to derive EECs.

Input Parameter Symbol Value Units

Application Rate A 0.11 lbs ai/A

Incorporation I 1 none

Runoff Fraction R 0.05 none

Drift Fraction D 0.01 none

Table E13. EECs for Flutriafol 125 g/l SC. Units in lbs ai/A.

Description Equation EEC

Runoff to dry areas (A/I)*R 0.0055

Runoff to semi-aquatic areas (A/I)*R*10 0.055

Spray drift A*D 0.0011

Total for dry areas ((A/I)*R)+(A*D) 0.0066

Total for semi-aquatic areas ((A/I)*R*10)+(A*D) 0.0561

Table E14. Plant survival and growth data used for RQ derivation. Units are in lbs ai/A.

Seedling Emergence Vegetative Vigor

Plant type EC25 NOAEC EC25 NOAEC 

Monocot >0.12 >0.12 >0.12 >0.12

Dicot >0.12 >0.12 >0.12 >0.12

Table E15. RQ values for plants in dry and semi-aquatic areas exposed to Flutriafol 125 g/l SC through 

runoff and/or spray drift.*

Plant Type Listed Status Dry Semi-Aquatic Spray Drift

Monocot non-listed <0.1 <0.47 <0.1

Monocot listed <0.1 <0.47 <0.1

Dicot non-listed <0.1 <0.47 <0.1

Dicot listed <0.1 <0.47 <0.1

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.
175

Appendix F. Ecological Effects Data

In this risk assessment, surrogate test species of birds, mammals, fish, aquatic and terrestrial 

invertebrates and plants are used to estimate treatment-related direct effects on acute mortality or 

immobility and chronic reproduction, growth, and survival of non-target species. Toxicity test 

values (i.e., measures of effect) are derived from the results of registrant-required animal toxicity

studies that are consistent with and meet toxicity testing guidelines (FIFRA 40 CFR Part 158 and 

160). Toxicity tests include short-term acute, subacute, and reproduction/chronic studies that 

progress from basic laboratory tests to applied field studies. In addition, avian species are used 

as surrogates for reptiles while freshwater fish species are used as surrogates for aquatic-phase 

amphibians. 

Toxicity to Aquatic Animals

Freshwater Fish, Acute (OPPTS 850.1075 Freshwater Fish Acute)

Two freshwater fish toxicity studies using the TGAI are required to establish the toxicity of 

flutriafol to fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill 

sunfish (a warmwater fish). Results are tabulated below (Table F1). 

Table F 1. Freshwater Fish Acute Toxicity with Flutriafol1

Species % ai 96-hour

LC50 (mg ai/L)

Toxicity 

Category*

New/(old) MRID No.

Author/Year

Study 

Classification

Rainbow trout

(Oncorhynchus mykiss) 93.0 52.3A

Slightly toxic 47090311 / (163466) 

Hill, R.W. (1982) Acceptable

Bluegill sunfish

(Lepomis macrochirus) 93.0 33B Slightly toxic 47090310 / (163467)Hill, R.W. (1985) Acceptable 

*Toxicity Category for Fish and Invertebrates: <0.1 = very highly toxic, 0.1 – 1 = highly toxic, >1 -10 = moderately toxic, >10 

-100 = slightly toxic, >100 = practically non-toxic

A Trout 95% Confidence Interval (C.I.) = 45.3-58.9 mg ai/L (binomial method); Probit slope = 3.89.

B Sunfish 95% C.I. = 23 – 44 mg ai/L; Probit slope = 4.04

1

values in bold are selected for the flutriafol risk assessment.

The 96-hr LC50s of flutriafol to freshwater fish range 33 – 52.3 mg ai/L, which fall in the toxicity

category as slightly toxic to freshwater fish on an acute exposure basis. The upgraded studies are 

scientifically sound and fulfill the OPPTS 850.1075 guideline requirement for acute toxicity to 

freshwater fish. 

MRID: 47090311

In a 96-h acute toxicity study, rainbow trout (Oncorhynchus mykiss) were exposed to PP450 

(flutriafol) at nominal concentrations of 0 (negative and solvent controls), 10.0, 18.0, 32.0, 56.0, 

75.0 and 100.0 mg ai/L under flow-through conditions. The reviewer-calculated time-weighted 

average (TWA) concentrations were <0.50 (<LOQ; controls), 7.9, 14.3, 26.1, 45.3, 58.9 and 

111.7 mg ai/L. The TWA LC50 and NOAEC for mortality were 52.3 and 45.3 mg ai/L, 

respectively. The TWA EC50 and NOAEC values, based on sub-lethal effects, were 17.3 and 7.9 

mg ai/L, respectively. Sub-lethal effects (i.e., dark discoloration, loss of equilibrium, quiescence, 
176

labored and/or rapid respiration, swelling of the gut, and coughing) were observed in the groups 

exposed to 14.3-111.7 mg ai/L of PP450. 

MRID: 47090310

In a 96-h acute toxicity study, bluegill sunfish (Lepomis macrochirus) were exposed to flutriafol 

at nominal concentrations of 0 (negative and solvent controls), 18, 32, 56, 100 and 180 mg ai//L

under static conditions; mean-measured concentrations were <1.8 (<LOQ; controls), 18, 32, 55, 

103 and 172 mg ai/L. The 96-h LC50 was 33 mg ai/L. The NOAEC value, based on mortality

and sub-lethal effects, was <18 mg ai/L; an EC50 value could not be determined. Sub-lethal 

effects (hyperactivity, spiraling, loss of balance, coughing and rapid and labored respiration) 

were reported; however, the study author did not specify the treatment levels that exhibited these 

effects. 

Additional Freshwater Fish Acute Studies Tested with Formulation Product of Flutriafol

Additional freshwater fish toxicity studies with rainbow trout and bluegill sunfish were also 

submitted by the registrant on the flutriafol formulation product, Flutriafol 125 g/l SC. Results 

are tabulated below (Table F 1a).

Table F 1a. Freshwater Fish Acute Toxicity with Flutriafol 125 g/l SC (Formulation Product)

Species % ai 96-hour

LC50

(mg form/L)

MRID No.

Author/Year

Study 

Classification

Rainbow trout

(Oncorhynchus mykiss) 11.6 7.9 47090312Sankey (1993) Acceptable 

Bluegill sunfish

(Lepomis macrochirus) 11.9 20

47090309

Palmer, Sutherland, and 

Kendall (2007)

Acceptable

Form – formulation product

The 96-hr LC50s range 7.9 – 20 mg form/L. The studies suggest the high toxicity of flutriafol in 

the formulation end use product to fish is primarily due to the toxicity of inerts in the 

formulation, not the active ingredient. The studies are scientifically sound and fulfill the OPPTS 

850.1075 guideline requirement for acute toxicity to freshwater fish. 

MRID: 47090309

In a 96-h acute toxicity study, bluegill sunfish (Lepomis macrochirus) were exposed to Flutriafol 

125 g/L SC (formulation containing the active ingredient flutriafol) at nominal concentrations of 

0 (negative control), 4.7, 7.8, 13, 22, and 36 mg formulation/L. The nominal concentrations 

based on flutriafol were 0 (negative control), 0.56, 0.93, 1.5, 2.6 and 4.3 mg ai/L under static 

conditions. The author calculated mean-measured concentrations of Flutriafol 125 g/L SC were 

<0.2 (LOQ; control), 4.8, 7.8, 13, 22, and 35 mg formulation/L. The reviewer calculated timeweighted average (TWA) concentrations of flutriafol were <0.200 (<LOQ; controls), 0.568, 

0.930, 1.54, 2.59 and 4.22 mg ai/L. The 96-h LC50 and NOAEC for mortality were 2.3 and 1.54 

mg ai/L, respectively. At test termination, the EC50 and NOAEC values, based on sub-lethal 

effects, was >2.59 and 2.59 mg ai/L, respectively. It is worthy to note that at 24 hours, sub-lethal 
177

effects (surfacing, loss of equilibrium, and lying on bottom of vessel) were observed in the 

groups exposed to 1.54 and 2.59 mg ai/L. 

MRID: 47090312

In a 96-h acute toxicity study, rainbow trout (Oncorhynchus mykiss) were exposed to Flutriafol 

125 g/L SC (formulation containing the active ingredient flutriafol) at nominal concentrations of 

0 (negative control), 0.75, 1.5, 3.0, 6.0, 12 and 24 mg form/L under flow through conditions. The 

mean-measured concentration of Flutriafol 125 g/L SC were <0.1 (<LOQ; control), 0.63, 1.4, 

2.7, 5.6, 11 and 23 mg form/L. The reviewer-calculated time-weighted average concentrations 

(TWA) of the active ingredient were <0.01 (<LOQ; control), 0.073, 0.16, 0.31, 0.65, 1.28, and 

2.67 mg ai/L. The 96-h LC50 and NOAEC for mortality were 0.9 and 0.67 mg ai/L, respectively. 

Sub-lethal effects (e.g., quiescence, sounding, ceased swimming, loss of balance, dark 

discoloration and irregular respiration) were observed in the 3 highest treatment levels exposed 

to flutriafol 125 g/L SC; however, complete mortality was observed at the highest level prior to 

the first observation at 24 hours. 

Freshwater Fish, Chronic (OPPTS 850.1400 Freshwater Fish Early Life Stage)

A freshwater fish early life-stage test using the TGAI is required for flutriafol because the enduse product may be applied directly to water or is expected to be transported to water from the 

intended use site. The preferred test species is fathead minnow. Results of this test are tabulated 

below (Table F 2).

Table F 2. Freshwater Fish Early Life-Stage Toxicity with Flutriafol Under Flow-through 

Conditions 

Species % ai NOAEC

(mg ai/L)

LOAEC

(mg ai/L)

Endpoints 

Affected

MRID No.

Author/Year

Study 

Classification

Fathead minnow

(Pimephales 

promelas)

95.1 4.8 9.5

post-hatch survival 

(most sensitive), 

post-hatch clinical 

signs of toxicity, 

and growth

47090317

Palmer, Kendall, and 

Krueger (2007)

Acceptable

Flutriafol caused significant reductions in post-hatch survival of rainbow trout at concentrations 

of 9.5 mg ai/L and higher establishing a NOAEC of 4.8 mg ai/L. This study is scientifically

sound and fulfills the OPPTS 850.1400 guideline requirement for chronic toxicity to freshwater 

fish. 

MRID: 47090317

No treatment-related effects on time to hatch or hatching success were observed. Hatching 

occurred between days 3 to 6 at all levels, and hatching success averaged 99 and 91% in the 

negative and solvent control groups, respectively, compared to 88, 95, 100, 98, and 90% in the 

mean-measured 1.2, 2.4, 4.8, 9.5, and 19 mg ai/L treatment levels, respectively. The slightly 

lower hatching success in the 1.2 and 19 mg ai/L treatment groups was primarily due to embryos 

that died from fungal infection on Day 5 (7 and 4 embryos, respectively). 

During the post-hatch period, a treatment-related increase in the incidences of clinical signs of 

toxicity (organisms that were small, weak, or had curved spines) was observed at the two 
178

highest-dosage treatment levels (9.5 and 19 mg ai/L). Furthermore, a treatment-related effect on 

post-hatch larval survival was observed at these levels. On Day 33 (study termination), larval 

survival averaged 94 and 96% in the negative and solvent control groups, respectively, compared 

to 87, 96, 89, 71, and 44% in the mean-measured 1.2, 2.4, 4.8, 9.5, and 19 mg ai/L treatment 

groups, respectively. Treatment-related effects on terminal growth (total length, wet weight, and 

dry weight) were observed at the highest-dosage treatment level (19 mg ai/L). 

Freshwater Invertebrates, Acute (OPPTS 850.1010 Freshwater Invertebrate Acute)

A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity

of flutriafol to aquatic invertebrates. The preferred test species is Daphnia magna. The results 

are tabulated below (Table F 3). 

Table F 3. Freshwater Invertebrate Acute Toxicity with Flutriafol*

Species % ai 48-hour EC50

(mg ai/L)

Toxicity 

Category

New / (old) 

MRID No.

Author/Year

Study 

Classification

Water flea

(Daphnia magna)

93.0 >63.5 (Test I) Slightly toxic 47090304 / (163468) 

Hamer and Hill (1982) acceptable

93.0 67 (Test II) Slightly toxic 47090304 / (163468) 

Hamer and Hill (1982) acceptable

Water flea (Test I) EC50 = 90 mg ai/L; 95% Confidence Interval = 69-538mg ai/L; Probit slope = Not reported. 

Water flea (Test II) 95% Confidence Interval = 59 - 78 mg ai/L; Probit slope = 5.43.

* Values in bold are selected for the flutriafol risk assessment. 

The 48-hr EC50s for water flea exposed to flutriafol technical that range 67 - 90 mg ai/L 

classifies the test material as slightly to practically nontoxic to the freshwater invertebrates on an 

acute exposure basis. The study is scientifically sound and fulfills the OPPTS 850.1010 guideline 

requirement for acute toxicity to freshwater invertebrates. 

MRID: 47090304

The 48-hour acute toxicity of PP450 (flutriafol) to Daphnia magna was studied twice under 

static conditions. During the first exposure, daphnids were exposed to nominal concentrations of 

0 (negative control), 1, 2, 4, 8, 16, 32 and 64 mg ai/L for 48 hours; mean-measured 

concentrations were <0.02 (<LOQ; control), 1.0, 1.9, 3.9, 8.1, 15.9, 30.3 and 63.5 mg ai/L. 

During the second exposure, daphnids were exposed to nominal concentrations of 0 (negative 

control), 2, 4, 8, 16, 32, 64 and 100 mg ai/L for 48 hours; mean-measured concentrations were 

<0.3 (<LOQ; control), 1.7, 3.8, 7.7, 15.5, 32.6, 59.5 and 90.1 mg ai/L. Immobilization and dead 

daphnids were observed after 4, 10, 24 and 48 hours in both tests. The 48-hour EC50 value from 

the first test was >63.5 mg ai/L. The 48-hour EC50 value from the second test was 67.1 mg ai/L. 

No sub-lethal observations were made. The 48-hr NOAEC based on immobility and dead 

daphnids were 15.9 mg ai/L from the first test and 15.5 mg ai/L from the second test. 

Additional Freshwater Invertebrate Acute Study with Formulation Product of Flutriafol 

Additional freshwater invertebrate toxicity study with the water flea was also submitted by the 

registrant on the flutriafol formulation product, Flutriafol 125 g/l SC. Results are tabulated 
179

below (Table F 3a).

Table F 3a. Freshwater Invertebrate Acute Toxicity with Flutriafol 125 g/l SC

Species % ai 48-hour EC50

(mg form/L)

Toxicity 

Category

MRID No.

Author/Year

Study 

Classification

Water flea

(Daphnia magna) 11.77 7.05 N/A 47090305Kent, S. (1994) Acceptable

Form – formulation product

The 48-hour EC50 value is 7.05 mg ai/L. The study suggests the high toxicity of flutriafol in the 

formulation product to daphnids is primarily due to the toxicity of inerts in the formulation, not 

the active ingredient. This study with the formulation product of flutriafol is scientifically sound 

and fulfills the OPPTS 850.1010 guideline requirements for acute toxicity to freshwater 

invertebrates. 

MRID: 47090305

The 48-hour acute toxicity of flutriafol (125 g/L SC Formulation) to Daphnia magna was studied 

under static conditions. Daphnids were exposed to nominal concentrations of 0 (negative 

control), 1.8, 3.2, 5.6, 10, 18 and 32 mg formulation/L for 48 hr; the nominal concentrations 

based on flutriafol were 0 (negative control), 0.21, 0.38, 0.66, 1.2, 2.1 and 3.8 mg ai/L. Meanmeasured concentrations were <0.013 (<LOQ; control), 0.19, 0.35, 0.62, 1.1, 2.1 and 3.9 mg 

ai/L. Mortality and immobility were observed daily. After 48 hours of exposure, immobility

was 0% in the negative control and mean-measured 0.19, 0.35 and 0.62 mg ai/L treatment 

groups. Complete immobility and dead daphnids were observed in the mean-measured 1.1, 2.1 

and 3.9 mg ai/L treatment groups. The 48-hour EC50 and 95% C.I. was 0.83 (0.62-1.1) mg ai/L. 

The 48-hr NOAEC based on immobility was 0.62 mg ai/L. No sub-lethal effects observations 

were made. 

Freshwater Invertebrate, Chronic (OPPTS 850.1300 Freshwater Invertebrate Life Cycle)

A freshwater aquatic invertebrate life-cycle test using the TGAI is required for flutriafol because 

the active ingredient may be transported to water from the intended use sites and may be persist 

in the aquatic environment. The preferred test species is the water flea (Daphnia magna). 

Results of this test are tabulated below (Table F 4).

Table F 4. Freshwater Aquatic Invertebrate Life-Cycle Toxicity with Flutriafol TGAI*

Species % ai NOAEC

(mg ai/L)

LOAEC

(mg ai/L)

Endpoint 

Affected

MRID No.

(Author/Year)

Study 

Classification

Water flea

(Daphnia magna)

95.5 0.31 0.55 Growth (length)

47090314

Williams, 

Stewart, and 

Tapp (1990)

Acceptable

95.5 1.0 3.2

Reproduction 

(most sensitive)

and survival

47090315

Batscher, R. 

(2004)

Supplemental1
180

Table F 4. Freshwater Aquatic Invertebrate Life-Cycle Toxicity with Flutriafol TGAI*

* Values in bold are selected for the flutriafol risk assessment.

1 Only the test solutions of the biologically relevant levels were analyzed in this study. Guideline requires all treatment 

levels including the biologically relevant levels be analyzed. 

Results indicate flutriafol caused significant reductions of growth at 0.55 mg ai/L and of 

reproduction at 3.2 mg ai/L to Daphnia magna establishing a NOAEC of 0.31 mg ai/L. The 

studies are both scientifically sound; however, the latter study (MRID 47090315) does not fulfill 

the OPPTS 850.1300 guideline requirement for chronic toxicity to freshwater invertebrates. 

MRID: 47090314

The 21-day-chronic toxicity of flutriafol to Daphnia magna was studied under static renewal 

conditions. Daphnids were exposed to flutriafol at nominal concentrations of 0 (negative 

control), 0.32, 0.56, 1.0, 1.8, 3.2, and 5.6 mg/L. Mean-measured concentrations were <0.03-

<0.19 (<LOD, control), 0.31, 0.55, 0.97, 1.8, 3.2, and 5.6 mg ai/L, respectively. The meanmeasured values are reported since the reviewer’s calculated time-weighted average (TWA) 

values were identical to the study author’s mean-measured concentrations. The 21-day NOAEC 

and LOAEC, based on terminal length measurements (the most sensitive endpoint), was 0.31 and 

0.55 mg ai/L, respectively. No first-generation mortality occurred at any test level during the 21-

day study. The time to first brood release was not assessed as a toxicological endpoint and raw 

data were not provided. It was reported that all first-generation daphnia from the control, 0.31, 

and 0.55 mg ai/L treatment levels released the first offspring by Day 9, and completed five 

broods of offspring. The total number of young produced (live and dead) per first-generation 

daphnid averaged 164 for the control group, compared to 164, 159, 123, 19, 0, and 0 for the 0.31, 

0.55, 0.97, 1.8, 3.2, and 5.6 mg ai/L treatment groups, respectively. Differences were 

statistically-reduced compared to the control (p=0.05) at the ≥0.97 mg ai/L levels. Of the total 

number of offspring produced, 7% were dead on removal from the 1.8 mg ai/L treatment level. 

In addition, aborted broods were observed at the 1.8, 3.2, and 5.6 mg ai/L treatment levels 

beginning on Day 8. The lengths of surviving daphnids after 21 days averaged 4.53, 4.49, 4.37, 

4.34, 4.39, 4.17, and 4.22 mm for the control, 0.31, 0.55, 0.97, 1.8, 3.2, and 5.6 mg ai/L 

treatment levels, respectively. Differences were statistically-reduced compared to the control 

(p=0.05) at the ≥0.55 mg ai/L levels.

MRID: 47090315

The 21-day-chronic toxicity of flutriafol to Daphnia magna was studied under static renewal 

conditions. Daphnids were exposed to flutriafol at nominal concentrations of 0 (negative 

control), 0.10, 0.32, 1.0, 3.2, and 10 mg ai/L. Recoveries of select test solutions indicated that 

flutriafol was stable under the conditions of the study. Mean-measured concentrations of the 

select test solutions were 0 (LOQ not reported; negative control), 1.02 and 3.2 mg ai/L which 

were identical to the nominal concentrations of 1.0 and 3.2 mg/L. The 21-day NOAEC and 

LOAEC, based on complete inhibition of reproduction at the 3.2 mg ai/L level (the most 

sensitive endpoint), were 1.0 and 3.2 mg ai/L, respectively. Survival ranged from 90-100% at the 

control through 3.2 mg ai/L levels, and was 0% at the 10 mg ai/L level, where all animals had 

died by Day 5. The time to first brood release was not assessed as a toxicological endpoint 

during the study. It was reported that all first-generation daphnia from the ≤0.32 mg ai/L 

treatment levels released the first offspring by Day 9 (Friday). At the 1.0 mg ai/L level, the first 
181

offspring were recorded on Day 12 (Monday, the next observation interval), and it was noted that 

the total number of offspring produced at this level through Day 14 exceeded the number 

produced at the ≤0.32 mg ai/L treatment levels. Reproduction was completely inhibited at the 

3.2 mg ai/L treatment level. The number of live offspring produced per surviving adult was 81.4 

for the control group, and 79.1, 77.6, 75.5, and 0.0 for the 0.10, 0.32, 1.0, and 3.2 mg ai/L

treatment groups, respectively. The difference was statistically significant (α=0.05) at the 3.2 mg 

ai/L level. No treatment-related effect on the lengths of surviving first-generation daphnids was 

observed. After 21 days, lengths averaged 3.89-3.99 mm for all levels. In addition, no visible 

abnormalities (excluding mortality and reduced reproduction rate) were observed in any animal 

during the test. 

Additional Freshwater Invertebrate Life-Cycle Study with Formulation Product of 

Flutriafol

Additional freshwater invertebrate life-cycle study with the water flea was also submitted by the 

registrant on the flutriafol end use product, Flutriafol 125 g/l SC. Results are tabulated below 

(Table F 4a).

Table F 4a. Freshwater Aquatic Invertebrate Life-Cycle Toxicity with Flutriafol 125 g/L SC 

(CHA 1310-03)

Species % ai NOAEC

(mg form/L)

LOAEC 

(mg form/L)

Endpoint 

Affected

MRID No.

(Author/Year)

Study 

Classification

Water flea

(Daphnia magna)

12.5 0.10 0.32 

Survival and 

reproduction 

(most sensitive)

47090316

Batscher, R. 

(2004)

Supplemental1

1 Only the test solutions of the biologically relevant levels were analyzed in this study. Guideline requires all treatment levels 

including the biologically relevant levels be analyzed. 

Results indicate Flutriafol 125 g/l SC caused significant reductions of reproduction at 0.04 mg 

ai/L to Daphnia magna establishing a NOAEC of 0.013 mg ai/L. The study suggests the high 

toxicity of flutriafol in the formulation product to daphnids is primarily due to the toxicity of 

inerts in the formulation, not the active ingredient. This study is scientifically sound but does not 

fulfill the OPPTS 850.1300 guideline requirements for chronic toxicity to freshwater 

invertebrates. 

MRID: 47090316

The 21-day life-cycle toxicity of CHA 1310-03 (a soluble concentration formulation containing 

12.5% flutriafol) to Daphnia magna was studied under static renewal conditions. Daphnids were 

exposed to the test material at nominal concentrations of 0 (negative control), 0.032, 0.1, 0.32, 

1.0, and 3.2 mg product/L. The reviewer-calculated nominal concentrations based on flutriafol 

were 0 (negative control), 0.004, 0.013, 0.04, 0.13, and 0.4 mg ai/L. Recoveries of select test 

solutions indicated that flutriafol was stable under the conditions of the study. Mean-measured 

concentrations of the select test solutions were 0 (LOQ not reported; negative control), 0.096 and 

0.32 mg form/L (0.012 and 0.04 mg ai/L) which were identical to the nominal concentrations of 

0.1 and 0.32 mg form/L (0.0125 and 0.04 mg ai/L). The 21-day NOAEC and LOAEC, based on 

offspring per parent (reproduction) at the ≥0.04 mg ai/L levels (the most sensitive endpoint), 

were 0.096 and 0.32 mg form/L (0.012 and 0.04 mg ai/L), respectively. Survival was 100% at 
182

the control through 0.13 mg ai/L levels, and 80% at the 0.4 mg ai/L level. The time to first brood 

release was not assessed as a toxicological endpoint during the study. It was reported that all 

first-generation daphnia from the ≤0.13 mg ai/L treatment levels released the first offspring by 

Day 9 (Friday). At the 0.4 mg ai/L level, the first offspring were recorded on Day 12 (Monday, 

the next observation interval). Reproduction was inhibited at the ≥0.04 mg ai/L treatment levels. 

The number of live offspring produced per surviving adult was 68.3 for the control group, and 

66.0, 63.6, 60.8, 58.6, and 51.1 for the 0.032, 0.1, 0.32, 1.0, and 3.2 mg form/L treatment groups, 

respectively. The differences were statistically significant (α=0.05) at the 0.32, 1.0, and 3.2 mg 

form/L levels. At the 1.0 and 3.2 mg form/L treatment levels, dead offspring were observed, 

mainly in the first brood. No treatment-related effect on the lengths of surviving first-generation 

daphnids was observed. After 21 days, lengths averaged 3.81-3.97 mm for all levels. In 

addition, no visible abnormalities (excluding mortality, reduced reproduction rate, and dead 

offspring) were observed in any animal during the test. 

Estuarine/Marine Fish, Acute (OPPTS 850.1075 Estuarine/Marine Fish Acute)

Acute toxicity testing with estuarine/marine fish using the TGAI is required for flutriafol because 

the end-use product is intended for direct application to the marine/estuarine environment or the 

active ingredient is expected to reach this environment because of its use in coastal counties. The 

preferred test species is sheepshead minnow. Results are tabulated below (Table F 5).

Table F 5. Estuarine/Marine Fish Acute Toxicity with Flutriafol TGAI

Species % ai 96-h LC50

(mg ai/L)

Toxicity

Category

MRID No.

(Author/Year)

Study 

Classification

Sheepshead minnow

(Cyprinodon 

variegatus)

95.1 >72.2A No more than 

slightly toxic

47090308

Palmer, Sutherland, 

Kendall, et al (2007)

Acceptable

A

a probit slope along with 95% confidence intervals could not be calculated due to lack of a concentration-response 

relationship.

The 96-hour LC50 value of >72.2 mg ai/L classifies flutriafol as no more than slightly toxic to 

Cyprinodon variegates on an acute exposure basis. This study is scientifically sound and fulfills 

the OPPTS 850.1075 guideline requirements for acute toxicity to estuarine/marine fish. 

MRID: 47090308

In a 96-h acute toxicity study, sheepshead minnow (Cyprinodon variegatus) was exposed to 

flutriafol technical at nominal concentrations of 0 (negative control), 18, 27, 42, 65 and 100 mg 

ai/L under static conditions. The reviewer-calculated TWA concentrations were <4.00 (LOQ; 

control), 13.8, 22.2, 34.2, 51.9 and 72.2 mg ai/L. By test termination, mortality was 45% at the 

72 mg ai/L treatment group. The 96-h LC50 was >72.2 mg ai/L. The EC50 and NOAEC values, 

based on sub-lethal effects, were 27.6 and 13.8 mg ai/L, respectively. Sub-lethal effects 

(lethargy, surfacing, loss of equilibrium and erratic swimming) were observed in the groups 

exposed to TWA concentrations of 22.2, 34.2, 51.9 and 72.2 mg ai/L of flutriafol. 

Estuarine/Marine Fish, Chronic (OPPTS 850.1400 Estuarine/Marine Fish Life-Cycle)

An estuarine/marine fish life-cycle toxicity test was not available for flutriafol.
183

Estuarine/Marine Invertebrates, Acute (OPPTS 850.1025 and 850.1035 Estuarine/Marine 

Invertebrate Acute)

Acute toxicity testing with estuarine/marine invertebrates using the TGAI is required for 

flutriafol because the end-use product is intended for direct application to the marine/estuarine 

environment or the active ingredient is expected to reach this environment because of its use in 

coastal counties. The preferred test species are mysid shrimp and eastern oyster. 

Table F 6. Estuarine/Marine Invertebrate Acute Toxicity with Flutriafol TGAI*

Species % ai.

96-h EC50/ LC50

(mg ai/L)

Toxicity

Category

MRID No.

(Author/Year)

Study 

Classification

Mysid shrimp

(Americamysis 

bahia)

95.1 34.9 Slightly 

toxic

47090307

Palmer, Sutherland, 

Kendall, et al (2007)

Acceptable

Eastern oyster

(Crassostrea 

virginia)

shell deposition

95.1 25 Slightly 

toxic

47090306

Palmer, Sutherland, 

Kendall, et al (2007)

Acceptable

Shrimp 95% Confidence Intervals: 30.8-47.2 mg ai/L; Probit slope = 7.43

Oyster 95% Confidence Intervals: 17 – 38 mg ai/L; Probit slope = 2.14 ± 0.864

* Values in bold are selected for the flutriafol risk assessment. 

Since the shrimp LC50 and oyster EC50 fall in the range of 10 – 100 mg ai/L toxicity category, 

flutriafol is categorized as slightly toxic to estuarine/marine invertebrates on an acute exposure 

basis. The studies are scientifically sound and fulfill the OPPTS 850.1025 and 850.1035 

guideline requirements for acute toxicity to estuarine/marine invertebrates. 

MRID: 47090306

The 96-hour acute toxicity of flutriafol technical to Crassostrea virginica was studied under 

flow-through conditions. Oysters were exposed to nominal concentrations of 0 (negative and 

solvent controls), 3.2, 5.4, 9.0, 15 and 25 mg ai/L. Time-Weighted Average (TWA) 

concentrations were <1.0 (<LOQ; control), 3.23, 5.51, 9.03, 14.6, and 24.2 mg ai/L. Mortality 

and shell deposition were observed daily. There was no mortality in this study, while inhibition 

of shell growth in the 3.23, 5.51, 9.03, 14.6, and 24.2 mg ai/L TWA treatment groups was -9.3, 

4.7, 20.9, 20.9, 23.3, and 53.5%, respectively. The reviewer-calculated TWA EC50 (95% C.I.) 

was 25 (17-38) mg ai/L. The TWA NOAEC based on shell deposition was 3.23 mg ai/L. No 

sub-lethal effects observations were made. 

MRID: 47090307

The 96-hour acute toxicity of flutriafol to Americamysis bahia was studied under static 

conditions. Mysids were exposed to nominal concentrations of 0 (negative control), 9.1, 15, 25, 

42, 70 mg ai/L. Time Weighted Average (TWA) concentrations were <4.0 (<LOQ; control), 8.1, 

13.1, 20.2, 30.8, and 47.2 mg ai/L. Mortality and sub-lethal effects were observed daily. After 

96-hours, mortality was 10, 10, 5, 10, 30, and 100% in the <4.0, 8.1, 13.1, 20.2, 30.8, and 47.2 

mg ai/L treatment groups. The reviewer-calculated TWA LC50 and NOAEC were 34.9 (30.8-

47.2) and 20.2 mg ai/L, respectively. Lethargy was observed among several mysids at the mean-
184

measured 31 and 47 mg ai/L treatment levels; by test termination, all surviving mysids at the 

mean-measured 31 mg ai/L treatment group were lethargic.

Estuarine/Marine Invertebrate, Chronic (OPPTS 850.1350 Estuarine/Marine Invertebrate 

Life-Cycle)

An estuarine/marine invertebrate life-cycle toxicity test was not available for flutriafol.

Toxicity to Aquatic Plants 

Aquatic Plants, Tier II (OPPTS 850.4400 and 850.5400 Vascular and Non-Vascular Plants)

Aquatic plant testing is required for any fungicide that has outdoor non-residential terrestrial uses 

and that may move off-site by runoff (solubility >10 mg/L in water), and/or by drift (aerial) or 

that is applied directly to aquatic use sites (except residential). Normally, Tier I testing with the 

TGAI or TEP is conducted on duckweed (Lemna gibba), a vascular species, and green algae 

(Skeletonema costatum), a nonvascular species. Then, Tier II testing is required if either species 

in Tier I is inhibited 50% or more, and includes Selenastrum capricornutum, Anabaena flosaquae, and a freshwater diatom. In this case, the registrant chose to conduct Tier II testing even 

though it may not have been triggered. Results based on the formulation product, Flutriafol 125 

g/l SC are tabulated below (Table F 7).

Table F 7. Toxicity of Flutriafol 125 g/l SC to Non-target Aquatic Plants (Tier II)*

Species % ai EC50

(mg ai/L)

NOAEC 

(mg ai/L)

MRID No.,

Author/Year

Study 

Classification

Vascular Plant Species

Vascular Plant- Duckweed

Lemna gibba 11.9 0.78 

(6.6 mg form/L)

0.018

1 

(0.15 mg form/L)

47090330

Desjardins, Kendall, 

and Krueger (2006)

Supplemental2

Non Vascular Plant Species

Non-Vascular Plant- Marine 

diatom

Skeletonema costatum

11.9 0.46 mg ai/L

(3.8 mg form/L)

0.1 mg ai/L

(0.84 mg form/L)

47090331

Desjardins, Kendall, 

and Krueger (2006)

Supplemental2

Non-Vascular Plant- Bluegreen cyanobacteria

Anabaena flos-aquae

11.9 14 2.9

47090334

Desjardins, Kendall, 

and Krueger (2006)

Supplemental2

Non-Vascular Plant- Green 

algae

Pesudokirchneriella 

subcapitata

11.9 0.6 0.241

47090333

Desjardins, Kendall, 

and Krueger (2006)

Supplemental2

Non-Vascular PlantFreshwater diatom

Navicula pelliculosa

11.9 1.0 0.35

47090332

Desjardins, Kendall, 

and Krueger (2006)

Supplemental2

* Values in bold are selected for the flutriafol risk assessment. 

1

Significant effects were observed at all levels, a NOAEC could not be established; therefore, the EC05 was used as a surrogate. 

2 Data were not available to establish an EC50 for the formulation inerts.
185

The Tier II result with the most sensitive nonvascular plant, S. costatum, indicates that growth 

inhibition of 5.1 - 96% was observed at concentrations of 0.093 – 0.71 mg ai/L, respectively. The 

Tier II result indicates the marine diatom EC50 of 0.46 mg ai/L is used to assess risk of Flutriafol

to non-listed nonvascular aquatic plants. It was determined that the NOAEC of 0.1 mg ai/L is 

used to assess risk to listed nonvascular aquatic plants. The duckweed EC50 of 0.78 mg ai/L is 

used to evaluate risk to non-listed vascular aquatic plants; the duckweed EC05 of 0.018 mg ai/L is 

used to evaluate risk to vascular aquatic plants that are endangered. In addition, the study

suggests the high toxicity of flutriafol in the formulation product to vascular and nonvascular 

aquatic plants is primarily due to the toxicity of inerts in the formulation, not the active 

ingredient.

MRID: 47090330

In a 7- day toxicity study, the freshwater floating aquatic vascular plants duckweed (Lemna 

gibba) were exposed to Flutriafol 125 g/L SC (formulation containing the active ingredient 

Flutriafol) at nominal concentrations of 0 (negative and formulation blank control), 1.1, 2.5, 5.6, 

12, 29, 63 mg formulation/L. Based on the active ingredient of flutriafol, the mean-measured 

concentrations are <0.0500 (<LOQ; negative and formulation blank controls), 0.13, 0.30, 0.66, 

1.5, 3.4 and 7.6 mg ai/L under static conditions. The NOAEC, EC05 and EC50 values based on 

biomass, the most sensitive endpoint, are <1.1, 0.15 and 5.6 mg formulation/L (<0.13, 0.018 and 

0.65 mg ai/L), respectively. The % growth inhibition, based on frond counts, in the treated 

culture as compared to the control ranged from 7.7-88%. In addition, significant reductions of 

biomass were observed at all treatment levels (i.e., NOAEC not available). Necrotic fronds were 

observed in the negative and formulation blank controls, however, only 0.29 and 1.1% of the 

surviving fronds were necrotic. Less than 1% of fronds were chlorotic in the formulation blank 

controls. Chlorotic and necrotic fronds were observed in all treatment groups on Day 7 with the 

percentage of necrotic fronds increasing with increasing concentration. Dead fronds (1.3%) were 

observed in the highest treatment group at test termination.

MRID: 47090331

In a 96-hour acute toxicity study, cultures of the marine diatom Skeletonema costatum (CCMP 

1332), were exposed to Flutriafol 125 g/L SC (formulation containing the active ingredient 

Flutriafol) at nominal concentrations of 0 (negative and formulation blank controls), 0.78, 1.3, 

2.2, 3.6 and 6.0 mg form/L. For flutriafol as the active ingredient, the mean-measured 

concentrations are 0 (negative and formulation blank controls), 0.10, 0.17, 0.28, 0.47 and 0.78 

mg ai/L under static conditions. The NOAEC and EC50 values based on biomass (the most 

sensitive endpoint) were 0.10 and 0.46 mg ai/L, respectively. The % growth inhibition, based on 

cell density, in the treated algal culture as compared to the control ranged from 6.4 to 96%. There 

were no compound-related phytotoxic effects.

MRID: 47090332

In a 96-hour acute toxicity study, cultures of freshwater diatoms Navicula pelliculosa (UTEX 

667), were exposed to Flutriafol 125 g/L SC (formulation containing the active ingredient 

Flutriafol) at nominal concentrations of 0 (negative and formulation blank controls), 1.5, 3.0, 6.0, 

12, 25, and 50 mg form/L. For flutriafol as the active ingredient, the mean-measured 

concentrations are 0 (negative and formulation blank controls), 0.17, 0.35, 0.70, 1.4, 2.9 and 5.9 

mg ai/L under static conditions. The NOAEC and EC50 values based on biomass, the most 
186

sensitive endpoint, were 0.35 and 1.0 mg ai/L, respectively. The % growth inhibition, based on 

cell density, in the treated algal culture as compared to the control ranged from -5.1 to 98%. 

There were no compound-related phytotoxic effects.

MRID: 47090333

In a 96-hour toxicity study, cultures of freshwater green algae Pseudokirchneriella subcapitata

(UTCC 37), were exposed to Flutriafol 125 g/L SC (formulation containing the active ingredient 

flutriafol) at nominal concentration of 0 (negative and formulation blank controls), 1.6, 2.6, 4.3, 

7.2, 12, and 20 mg form/L. The mean-measured concentrations of the active ingredient, 

flutriafol, are 0 (negative and formulation blank controls), 0.19, 0.32, 0.52, 0.89, 1.5 and 2.4 mg 

ai/L under static conditions. The NOAEC, EC05 and EC50 values based on biomass, the most 

sensitive endpoint, were <0.19, 0.24 and 0.60 mg ai/L, respectively. The % growth inhibition, 

based on cell density, in the treated algal culture as compared to the control ranged from 14 to 

100%. There were no compound-related phytotoxic effects.

MRID: 47090334

In a 96-hour toxicity study, cultures of freshwater blue-green algae (Cyanobacteria), Anabaena 

flos-aquae (UTCC 67), were exposed to Flutriafol 125 g/L SC (formulation containing the active 

ingredient futriafol) at nominal concentrations of 0 (negative and formulation blank controls), 

2.2, 4.9, 11, 24, 54, and 120 mg form/L. The mean-measured concentrations of flutriafol are 0 

(negative and formulation blank controls), 0.26, 0.58, 1.3, 2.9, 6.4 and 14 mg ai/L under static 

conditions. The NOAEC and EC50 values based on cell density and biomass, the most sensitive 

endpoints, were 2.9 and 14 mg ai/L. The % growth inhibition, based on cell density, in the 

treated algal culture as compared to the control ranged from -17 to 44%. There were no 

compound-related phytotoxic effects.

Toxicity to Terrestrial Animals 

Birds, Acute and Subacute (OPPTS 850.2100 Avian Acute Oral)

An acute oral toxicity study using the technical grade of the active ingredient (TGAI) is required 

to establish the toxicity of flutriafol to birds. The preferred test species is either mallard duck (a 

waterfowl) or bobwhite quail (an upland game bird) and a passerine bird. Results of avian acute 

oral toxicity studies are tabulated below (Table F 8). 
187

Table F 8. Avian Acute Oral Toxicity with Flutriafol TGAI

Species % ai LD50

(mg ai/kg bw)

Toxicity 

Category*

New / (old) MRID No.

Author/Year

Study

Classification

Red-Legged partridge

(Alectoris rufa)

93 616A Slightly 

toxic

47090319

Roberts and Fairley 

(1982)

 SupplementalB

Northern bobwhite 

quail

(Colinus virginianus)

95.1 810 Slightly 

toxic

47471301

Hubbard and Beavers 

(2008)

Acceptable

Mallard duck

(Anas platyrhynchos)

93.0 >5000C Practically 

nontoxic

47090318 / (163464)

Roberts and Fairley

(1982)

Acceptable

*Toxicity Category for Birds and Mammals via Oral Route: <10 = very highly toxic, 10 - 50 = highly toxic, 51 -500 = 

moderately toxic, 501 -2000 = slightly toxic, >2000 = practically non-toxic

A

Partridge 95% Confidence Intervals = 342 – 1108 mg ai/kg bw; Probit slope = N/A (binomial test).

B >5% mortality occurred during acclimation 

C

a probit slope along with 95% confidence intervals could not be calculated due to lack of a concentration-response 

relationship. 

Because the non-passerine LD50 falls between 501 and >2000 mg ai/kg-bw, flutriafol TGAI is 

categorized as slightly to practically non-toxic to birds on an acute oral basis. Data with a 

passerine bird is not available, thus, the guideline (OPPTS 850.2100) is not fulfilled. 

Red-legged partridge (MRID 47090319) 

In summary, cumulative mortality in partridges were 0% (control), 0, 0, 50, 100, and 100% at the 

0, 190, 342, 616, 1108, and 1995 mg ai/kg bw treatment levels, respectively. All deaths occurred 

on Day 1-6. Clinical signs of toxicity of subdued behavior, unsteadiness, weakness, and 

squatting and/or prostration were observed in the three highest levels. Treatment-related effects 

of reduced food consumption was observed in the 342 and 616 mg ai/kg bw for females. No 

treatment-related effects on body weight gains or upon necropsy were observed.

Mallard duck (MRID 47090318)

In summary, of the 1069, 1572, 2312, 3400, and 5000 mg ai/kg-bw treatment groups, there were 

no treatment-related effects or signs of toxicity observed in control and the three lowest-dosage 

groups. At test termination, three birds in the 3400 mg/kg group and three birds in the 5000 

mg/kg group were dead. Signs of toxicity observed in the dead birds were unsteadiness or unable 

to stand. No other abnormalities were observed and all surviving birds were in good health. Over 

day 0 to 3, mean body weight decreases were observed in all groups with control birds showing a 

mean body weight increase. Group mean body weight changes were within normal limits after 

day 3. Reduced food consumption was observed in the two highest-dosage groups. A postmortem examination of the birds revealed pale livers, fluid in the body cavity, intestines stained 

red, pale kidneys, hard white lump in body cavity, and white nodule or spots on livers.

Birds, Subacute (OPPTS 850.2200 Avian Subacute Dietary) 
188

Two subacute dietary studies using the TGAI are required to establish the subacute toxicity of 

flutriafol to birds. The preferred test species are mallard duck and bobwhite quail. Results of the 

tests are tabulated below (Table F 9). 

Table F 9. Avian Subacute Dietary Toxicity with Flutriafol TGAI

Species % ai 8-Day LC50

(mg ai/kg-diet)

Toxicity 

Category

New / (old) 

MRID No.

Author/Year

Study 

Classification 

Northern bobwhite quail

(Colinus virginianus) 93.0 6532A Practically 

nontoxic

47090321 / 

(163680)

Roberts, N.L. 

and et al (1986)

acceptable

Mallard duck

(Anas platyrhynchos)

93.0 4062BSlightly toxic

47090320 / 

(163465)

Roberts, 

Fairley, and 

Almond (1982)

acceptable

*Toxicity Category for Birds and Mammals via Dietary Route: <50 = very highly toxic, 50 – 500 = highly toxic, 501-1000 = 

moderately toxic, 1001-5000 = slightly toxic, >5000 = practically non-toxic

A Quail 95% Confidence Interval = 5240 - 7700 mg ai/kg-diet; Probit slope = N/A (binomial test).

B Duck 95% CI = 2985-5521 mg ai/kg-diet (moving average); Probit slope = 2.7.

Because the LC50 falls between 1001 and >5000 mg ai/kg-bw, flutriafol is categorized as slightly 

to practically non-toxic to birds on a subacute dietary basis. The guideline (OPPTS 850.2200) is 

fulfilled. 

Cumulative mortality in mallard ducks (MRID 47090320) was 0% (control), 10, 10, 30, 80, 70, 

100, and 90% in the <LOQ, 1136, 1832, 2955, 4767, 7688, 12400, and 20000 mg ai/kg-diet 

treatment groups, respectively. All mortality occurred on Day 3 -7. Unsteadiness was observed in 

two highest levels. Treatment-related effects on body weight and food consumption were 

observed at all levels; the effects increased with increasing concentration. Necropsy revealed 

pale or blotchy livers.

Cumulative mortality in bobwhite quails (MRID 47090321) was 0% (control), 0, 0, 0, 0, 100, 

and 100% in the <LOQ, 594, 1100, 2180, 5240, 7700, and 10700 mg ai/kg-diet, respectively. All 

mortality occurred on Day 1 – 4. Subdued behavior and/or unsteadiness were observed in the 

three highest levels. A treatment-related effect on food consumption was observed in the four 

highest levels. No treatment-related effects on body weight or upon necropsy were observed.

Birds, Chronic (OPPTS 850.2300 Avian Reproduction)

Two avian reproduction studies using the TGAI in the diet are required to establish the chronic 

toxicity of flutriafol to birds. The preferred test species are mallard duck and bobwhite quail. 

Results of the tests are tabulated below (Table F 10). 
189

The data that were submitted show the reproduction NOAEC for duck and quail to be 39.2 and 

<95.0 mg ai/kg diet, respectively. Results indicate the mallard duck is plausibly more sensitive to 

flutriafol than the bobwhite quail; therefore, the duck NOAEC value of 39.2 mg ai/kg-diet is 

used to evaluate potential chronic effects to birds. The guideline (OPPTS 850.2300) is fulfilled. 

The duck study (MRID 47090322) is classified as acceptable while the quail study (MRID 

47090323) is considered supplemental in the absence of an NOAEC as a result of significant 

effects at all test levels.

MRID: 47090322

The one-generation reproductive toxicity of flutriafol to 16 pairs per level of 18-week old 

mallard duck (Anas platyrhynchos) was assessed over approximately 21 weeks. Flutriafol was 

administered to the birds in the diet at nominal concentrations of 0 (negative control), 40, 100, 

300, and 1000 mg ai/kg dw diet. Mean-measured concentrations were <20 (<LOD, control), 

39.2, 97.5, 315, and 1070 mg ai/kg diet, respectively. The estimated daily dietary dose was 0.0, 

6.0, 13.1, 39.4, and 163.8 mg ai/kg bw/day, respectively. There was no treatment-related 

mortality or clinical signs of toxicity noted at any treatment level. However, effects on food 

consumption and female body weights were observed at the 1070 mg ai/kg diet level. Mean feed 

consumption was significantly-increased at the 1070 mg ai/kg diet group compared to the control 

group during weeks 5 through 9 (153 to 209 g/bird/day compared to 80 to 131 g/bird/day for the 

control group). Overall, feed consumption averaged 161, 180, 154, 157, and 186 g/bird/day for 

the control, 39.2, 97.5, 315, and 1070 mg ai/kg diet levels, respectively. The body weight of 

females from the 1070 mg ai/kg diet level was statistically-reduced compared to the control 

during Weeks 4 (p<0.05; 1040 versus 1138 g, respectively) and 21 (p<0.01, 1057 versus 1206 g, 

Table F 10. Chronic Toxicity of Flutriafol TGAI to Bobwhite Quail and Mallard Ducks.

Species % 

a.i.

NOAEC

(mg/kg-diet)

LOAEC 

(mg/kg-diet)

Most Affected 

Endpoints

MRID no.

Author/Year

Study Classification

Northern bobwhite 

quail

(Colinus 

virginianus)

94.4 <95 95

% survivors of 

eggs set and 14-

day old survivors’ 

body weights

47090323 

Thompson, H. 

(2007)

Supplemental1

Mallard duck

(Anas 

platyrhynchos)

95.1 39.2 97.5

Reproduction

(percentage of 

hatchlings of live 

3-week embryos, 

percentage of 

hatchling of eggs 

set, 14-day 

survivors, and 

number of 

hatchling)

47090322

Temple, Frey, 

Beavers, et al 

(2007)

Acceptable

1

Significant effects were observed at all treatment levels, a NOAEC could not be determined. The study needs to establish an NOAEC 

with lower concentrations. 
190

respectively). Overall, the 1070 mg ai/kg diet group females had a reduction in mean body 

weight (-47 g) while the females in all the other groups had an increase in mean body weight (88 

to 143 g). Gross necropsy at study termination indicated increased incidences of small testes in 

the males and regressed ovaries in the females from the 1070 mg ai/kg diet level that were 

considered related to treatment. Treatment-related effects upon reproduction were observed at 

all test concentrations. At the 39.2 and 97.5 mg ai/kg diet levels, there were apparent treatmentrelated effects upon hatchability (no. of hatchlings relative to no. of live 3-week embryos), 

although the differences were not statistically-significant and not clearly dose-related. 

Hatchability was 63 and 65% for the 39.2 and 97.5 mg ai/kg diet levels, respectively, compared 

to 80% for the control level. Statistically-significant adverse effects were detected at the 97.5 

mg ai/kg diet level for number hatched, number hatched of eggs set, and hatchling survival. At 

the 315 mg ai/kg diet level, a treatment-related reduction (p=0.042) in egg production was 

observed. A total of 703 eggs were laid at the 315 mg ai/kg diet level, compared to 856 for the 

control level, and the no. of eggs laid relative to the maximum no. of eggs laid was 59% at the 

315 mg ai/kg diet level, compared to 72% for the control level. 

Numerous treatment-related reductions in reproduction were adversely affected at the 1070 mg 

ai/kg diet level compared to the control response (percentages in parentheses below represent 

reductions from control values). 

 eggs laid per female (p≤0.001; 93%)

 eggs set per female (p≤0.01; 93%)

 viable embryos (p≤0.001; 95%)

 Live 3-week embryos (p≤0.001; 98%)

 % live 3-week embryos of viable embryos (p≤0.001; 57%)

 % normal hatchlings (p≤0.001; 99%)

 % normal hatchlings of eggs laid (p≤0.001; 87%)

 % normal hatchlings of eggs set (p≤0.001; 88%)

 % normal hatchlings of live 3-week embryos (p≤0.001; 82%) 

 % 14-day survivors (p≤0.001; 99%) The control group produced a total of 558 14-day

old survivors, the 1070 mg ai/kg group produced only two 14-day old survivors. 

 % 14-day survivors of eggs set (p≤0.001; 89%)

There were no treatment-related differences observed upon hatchling or 14-day survivor body 

weights at the 39.2, 97.5, or 315 mg ai/kg diet levels. As there were only three hatchlings and 

two 14-day survivors at the 1070 mg ai/kg diet level, insufficient data were available to 

assessment these endpoints at this level. As of a result, the LOAEC and NOAEC based on 

significant reductions of hatchability (percentage of hatchlings of live 3-week embryos, 

percentage of hatchling of eggs set, 14-day survivors, and number of hatchling) were 97.5 and 

39.2 mg ai/kg diet, respectively. 

MRID: 47090323

The one-generation reproductive toxicity of flutriafol to 20 pairs per level of approximately 6-

month old Northern bobwhite quail (Colinus virginianus) was assessed over 22 weeks. Flutriafol 

was administered to the birds in the diet at nominal concentrations of 0 (vehicle control), 100, 

300, and 1000 mg/kg diet (not corrected for purity). Mean-measured concentrations were <LOD 
191

(control), 95.0, 274, and 986 mg ai/kg diet, respectively. There were no definitive treatmentrelated effects on any adult parameter, including mortality, clinical effects, body weight, food 

consumption, or necropsy findings of decedent and surviving animals. In addition, no 

statistically-significant differences were observed on the number of cracked eggs per female, the 

proportion of eggs not cracked to eggs laid, egg shell thickness, the proportion of eggs set to 

eggs laid, the proportion of hatchling survivors to normal hatchling, and hatchling weight. 

There were numerous treatment-related reductions in reproduction at the 986 mg ai/kg diet level 

compared to the control response (percentages in parentheses below represent reductions from 

control values). 

 eggs laid per female (p≤0.001; 34%)

 eggs set per female (p≤0.01; 32%)

 viable embryos (p≤0.001; 48%)

 % viable embryos of eggs set (p≤0.01; 19%)

 Live 3-week embryos (p≤0.001; 65%)

 % live 3-week embryos of viable embryos (p≤0.001; 47%)

 % normal hatchlings (p≤0.001; 98%)

 % normal hatchlings of eggs laid (p≤0.001; 98%)

 % normal hatchlings of eggs set (p≤0.001; 98%)

 % normal hatchlings of live 3-week embryos (p≤0.001; 97%) 

 % 14-day survivors (p≤0.001; 99%) 

Significant adverse effects for the proportion of hatchling survivor to eggs set and 14-day

survivor weight were observed at all treatment levels. Based on statistically significant effects on 

survivors as a function of eggs set and body weight, a NOAEC could not be determined in this 

study (<95.0 mg ai/kg diet). The LOAEC was determined to be 95 mg ai/kg diet. 

This study is scientifically sound, but it does not fulfill the U.S. EPA guideline §OPPTS 

850.2300 because a NOAEC could not be determined. As a result, this study is classified as 

SUPPLEMENTAL. The most sensitive reproductive parameters were the ratio of hatchling 

survival to number of eggs set and 14-day old survivor weight, which was adversely affected at 

all treatment levels. The study needs to be repeated at lower concentrations of flutriafol to 

establish a reproductive NOAEC for this avian species.

Supplemental Bird Studies – Accumulation and Depletion

In a 42-day sub-chronic study (MRID 47090303), the accumulation and depletion of radioactive 

flutriafol was examined in tissues of mallard duck (Anas platyrhynchos) and bobwhite quail 

(Colinus virginianus). [14C] flutriafol was administered to groups (one pair per sex) of birds 

once daily via gelatin capsule at a measured average daily dose rate of 0.21 mg/kg bw. Birds 

were dosed for up to 28 days, followed by a 24- to 360-hour withdrawal period. Sampling of 

liver, kidneys, muscle (breast and leg), brain, and fat tissue occurred on Days 7, 14, 21, and 28 

and at 7 and 14 days following the final dose. Results indicated that with the exception of livers, 

which contained residues of 0.25-0.41 mg/kg and 0.17-0.23 mg/kg for ducks and quail,

respectively, during the dosing period, the residues of flutriafol in bird tissue were much lower 
192

than the dose rate. Residues in the liver were rapidly established (by 7 days), and did not show 

any significant accumulation throughout the remaining period. A rapid depletion was observed 

upon cessation of dosing, with residues ranging from 0.06-0.07 mg/kg and 0.02-0.04 mg/kg for 

ducks and quail, respectively, 192 hours after the final dose. Results in tissues of male and 

female birds were very similar; expect for quail kidneys, where slightly higher levels were found 

in male birds. Concentrations of radioactivity were very similar in breast and leg muscle. No 

eggs were produced by any of the birds during the study.

Mammals, Acute and Chronic (OPPTS 870.1100 Acute Mammalian Oral and OPPTS 

870.3800 Mammalian Reproduction)

Wild mammal testing is required on a case-by-case basis, depending on the results of lower tier

laboratory mammalian studies, intended use pattern and pertinent environmental fate 

characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's Health 

Effects Division (HED) substitute for wild mammal testing. These toxicity values are reported 

(Table F 11) below.

Table F 11. Mammalian Toxicity with Flutriafol TGAI and Flutriafol 125 g/L SC

Species % ai Test Type Toxicity

Value

Reference

(Classification)

Flutriafol TGAI

laboratory 

mouse

11.9

acute oral LD50 Males = 365; 

Females = 179 mg ai/kg-bw MRID # 47090335

(acceptable)

laboratory rat

acute oral LD50 Males = 1140; 

Females = 1480 mg ai/kg-bw

2-generation 

reproduction

Parental

NOAEL = 240 ppm 

(20.6 mg ai/kg-dt in P 

males; 21.9 in P females)

LOAEL = 1000 ppm 

(88.7 mg ai/kg-dt in P 

males; 103 in P females)

MRID # 47090351

(acceptable)

Reproductive

NOAEL = 1000 ppm 

(88.7 – 103 mg ai/kgdiet)

LOAEL >1000 ppm

Flutriafol 125 g/L SC

laboratory rat 11.9

acute oral LD50 Males and Females: >2000 mg form/kg

MRID # 47090003

(acceptable)

acute dermal

LD50 Males and Females: >2000 mg form/kg

MRID # 47090004

(acceptable)

LD50 Males and Females: >4000 mg form/kg

MRID # 47090005

(acceptable)

 

In the mammalian risk assessment for flutriafol TGAI, the acute oral toxicity value of 179 

mg/kg-bw is used for assessing acute risk to mammalian species. Based the mouse and rat acute 

oral studies, flutriafol TGAI is moderately to slight toxicity to mammals. Even though there was 

no apparently reproduction effects as high as 1000 mg ai/kg-diet, significant effects of decreased 

body weight gains, food consumption, and effects on the liver to parental rats and low birth index 

and litter size along with effects on the liver to offspring rats were observed. The TGAI NOAEL 
193

is 240 ppm (20.6 P males; 21.9 P females). Available toxicity data with the formulation product, 

Flutriafol 125 g/L SC, indicates the product acute oral value of >2000 mg form/kg is practically 

nontoxic to rats. 

MRID: 47090335

In an acute oral toxicity study, groups of five male and five female Alderley Park (SPF) fasted 

(16-20 hrs before dosing) rats were given single gavage doses of PP450 (93% a.i.; Batch No. 

P10, D2518/75) in aqueous 0.5% LISSATAN AC at doses of 750, 1000, 1500, 2000, or 2500 

mg/kg bw (10 mL/kg dose volume). Animals were dosed on day 1 and then observed for 14 

days. The animals were 5-7 weeks old (males: 140-245 g; females: 115-190 g) and supplied by

the Animal Breeding Unit of the testing laboratory.

Mortality was as follows: at 750 mg/kg bw, none; at 1000 mg/kg bw, 2 males and 1 female; at 

1500 mg/kg bw, 4 males and 3 females; at 2000 mg/kg bw, 5 males and 3 females; and at 2500 

mg/kg bw 5 males and 5 females. The deaths or moribund sacrifices occurred between days 2 

and 8. No abnormal clinical signs were seen in females dosed at 750 mg/kg bw; all other rats 

showed signs of toxicity. Dehydration, piloerection, and upward curvature of the spine were seen 

in 3-5 animals from all of the other groups, including males at 750 mg/kg. Other notable 

findings included decreased abdominal tone, decreased activity, hypothermia, “sides pinched in,” 

urinary incontinence or signs thereof, loss of righting reflex, shaking, and loss of stability. 

Among survivors, one male from each of the 750, 1000, and 1500 mg/kg groups and one female 

from each of the 1500 and 2000 mg/kg groups lost weight during days 1-3 or 3-6 with recovery

by day 8. All surviving animals gained weight during the second week of the study. Red 

discoloration of the lungs was seen in one 1500 mg/kg male and one 2500 mg/kg male; these 

were animals that were sacrificed in extremis.

LD50 Males = 1140 mg/kg bw (95% Confidence Limits 880-1470 mg/kg bw)

LD50 Females = 1480 mg/kg bw (95% Confidence Limits 1090-1980 mg/kg bw)

LD50 Combined > 1000 and < 1500 mg/kg bw

Based on the acute oral LD50, PP450 is classified as EPA Toxicity Category III. This study is 

classified as acceptable. It does satisfy the guideline requirements for an acute oral study

(OPPTS 870.1100; OECD 401) in the rat.

MRID: 47090335

In an acute oral toxicity study, groups of five male and/or five female Alderley Park (SPF) fasted 

(16-20 hours) albino mice were given single gavage doses of PP450 (93% a.i.; Batch No. P10, 

D2518/75) in aqueous 0.5% LISSATAN AC at doses of 50 (females only), 100 (females only), 

200, 300 (males only), 350 (males only), 400, 600 (females only), 800 and 1000 mg/kg bw, at a 

standard 10 mL/kg dose volume. Animals were dosed on day 1 and then observed for 14 days. 

The mice were 5-7 weeks old, weighed 22-40 g, and were supplied by the Animal Breeding Unit 

of the testing laboratory.

Mortality was as follows: at 50 mg/kg 1/5F; 100 mg/kg: 4/5F; 200 mg/kg: 0/4M & 1/5F; 300 

mg/kg; 0/5M; 350 mg/kg: 2/5M; 400 mg/kg: 4/5M & 1/5F; 600 mg/kg: 4/5F; 800 mg/kg: 5/5M 

& 5/5F; 1000 mg/kg: 5/5M & 4/4F. Deaths occurred between day 1 (the day of dosing) and day
194

4. Signs of toxicity occurred at all dose levels, and included decreased activity, dehydration, 

hypothermia, decreased abdominal tone, ptosis, piloerection, pinched in sides, upward curvature 

of the spine, loss of corneal reflex and loss of righting reflex. Signs of toxicity were still present 

in some mice on day 8. Initially, all mice had a decrease in bodyweight (due to fasting before 

the dosing). By day 8 survivors had equaled or surpassed their initial (day -1) bodyweights. 

Only some of the mice were examined by necropsy; the lungs of two mice (1M, 1F) dosed at 200 

mg/kg appeared red in color.

LD50 Males = 365 mg/kg bw (95% Confidence Limits 312-434 mg/kg bw)

LD50 Females = 179 mg/kg bw (95% Confidence Limits could not be calculated)

LD50 Combined not reported

Based on the mouse acute oral LD50, PP450 is classified as EPA Toxicity Category II. This 

study is classified as acceptable. It does satisfy the guideline requirements for an acute oral 

study (OPPTS 870.1100; OECD 401) in the mouse.

MRID: 47090351

In a two-generation reproduction toxicity study, Flutriafol (93%; Batch # P10) was administered 

in the diet to 15 male and 30 female Wistar rats/sex/dose group at dietary levels of 0, 60, 240, or 

1000 ppm (calculated to be 0, 4.8, 20.6 and 88.7 mg/kg bw/day in P males; and, 0, 5.5, 21.9 and 

103 mg/kg bw/day in P females) for two successive generations with two litters per generation. 

The P generation animals were fed the test diets for 12 weeks prior to mating to produce the F1a 

litters. After weaning of the F1a litter, the females were mated with a different male to produce 

the F1b litters. On post-natal day (PND) 36, offspring from the F1b litters were selected to be 

parents and were fed the same test diet concentration as their dam for 11 weeks prior to mating to 

produce the F2a litters. This procedure continued through weaning of the F2b litters which was 

produced by mating of the F1b. There were no treatment-related deaths or clinical signs of 

toxicity. 

Treatment-related effects on body weight gain, food consumption, and food utilization during the 

pre-mating period were observed at 1000 ppm.

Body weight gains were decreased (p<=0.05, unless otherwise noted) at 1000 ppm compared to 

controls: throughout the pre-mating period in the P males (decr. 6-8%); beginning at Week 7 in 

the P females (decr. 4-6%, not significant [NS] at Week 8); and throughout pre-mating in the F1 

females (decr. 6-18%; NS at Week 6).

Food consumption was decreased (p<=0.05) at 1000 ppm compared to controls: generally 

throughout pre-mating in the P males (decr. 4-7%), resulting in a decrease in total food 

consumption (Weeks 1-12) of 2% (p<=0.01) compared to controls; beginning at Week 6 in the P 

females (decr. 6-8%), resulting in a decrease of 5% (p<=0.01) in total food consumption; and at 

Week 8 in the F1 females (decr. 6%; p<=0.01).

Food utilization was increased by 3% (p<=0.01) compared to controls in the 1000 ppm P males 

for Weeks 1-4. Food utilization was increased by 10% (p<=0.05) over controls in the F1 females 

at this dose for Weeks 1-4, resulting in an increase of 8% (p<=0.01) for the overall (Weeks 1-11) 
195

pre-mating period.

Throughout gestation, cumulative body weight gains were decreased by 3-25% at 1000 ppm in 

the P dams during both litters and in the F1 dams during the F2b litter. With the exception of the 

P females on GD 8 and 22 during the F1a litter and the F1 females on GD 22 during the F2b 

litter, these decreases were significantly (p<=0.05) different from controls.

Absolute and adjusted (for body weight) liver weights were increased (p<=0.01) by 11-29% over 

controls in both sexes in both generations, with the exception of the absolute liver weight in the P 

females, which was increased by 6% over controls (NS).

Treatment-related microscopic findings were found in the liver. Centrilobular hypertrophy was 

observed in 1000 ppm males in the P generation (2/15 treated vs 0/15 controls) and F1 

generation (4/15 treated vs 0/15 controls). Increased incidences of fatty change in the liver were 

observed at this dose in the P generation males (8/15 treated vs 0/15 controls) and females (5/30 

treated vs 1/30 controls) and in the F1 generation males (13/15 treated vs 0/15 controls) and 

females (3/30 treated vs 0/30 controls). Fatty change was also observed in the 240 ppm F1 males 

(5/15 treated vs 0/15 controls). The LOAEL for parental toxicity is 1000 ppm (88.7 mg/kg 

bw/day in P males; and, 103 mg/kg bw/day in P females) based on decreased body weight 

gains and food consumption and on effects on the liver (increased liver weights, 

centrilobular hypertrophy, and fatty change). The NOAEL is 240 ppm (20.6 mg/kg bw/day 

in P males; and, 21.9 mg/kg bw/day in P females).

Although no data were provided, it was stated that the offspring generally remained in good 

clinical condition and that there were no clinical abnormalities which could be related to 

treatment. There were no effects of treatment on the offspring survival indices (percent pups 

surviving to PND 22 and proportion of litters with all pups surviving to PND 22) or cumulative 

pup body weight gains throughout the post-natal period. At necropsy, no macroscopic findings 

could be attributed to treatment. 

At 1000 ppm, litter size was decreased (p<=0.05) throughout the post-natal period in the F1b 

litter (decr. 17-18%) and in the F2a litter (decr. 22-23%). The percent of pups born alive was 

decreased (p<=0.05) in the F2a litter (94.9% treated vs 100% controls) and F2b litter (90.1% 

treated vs 99.3% controls). The proportion of litters with all pups born alive was decreased at 

this dose in the F2a litter (15/20 treated vs 18/18 controls) and F2b litter (19/29 treated vs 24/26 

controls). In the liver, fatty change was observed at 1000 ppm in the F1b male pups (1/7 treated 

vs 0/6 controls) and F1b female pups (1/6 treated vs 0/8 controls). Fine vacuolar hepatocyte 

vacuolation/fatty change was observed in the F2b males (5/10 treated vs 0/10 controls) and F2b 

females (1/10 treated vs 0/10 controls). The LOAEL for offspring toxicity is 1000 ppm (88.7 

mg/kg bw/day in males; and, 103 mg/kg bw/day in females) based on decreased live birth 

index and litter size and on effects on the liver (fatty change/vacuolation). The NOAEL is 

240 ppm (20.6 mg/kg bw/day in males; and, 21.9 mg/kg bw/day in females). 

There was no apparent effect of treatment on estrous cycle duration or periodicity in the P 

generation. There were no effects of treatment on precoital interval, gestation duration, or 

fertility in either litter in either generation. The LOAEL for reproductive toxicity was not 
196

observed. The NOAEL is 1000 ppm (88.7 - 103 mg/kg bw/day). This study is classified as 

acceptable/guideline and satisfies the guideline requirements (OPPTS 870.3800; OECD 416) 

for a two-generation reproduction study in the rat.

MRID: 47090003

In an acute oral toxicity study (MRID 47090003), 5/sex of Alpk: APf SD (Wistar-derived) rats 

(age: 8-12weeks; source: Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire; 355-419 

g males and 214-248 g females) were given a single oral dose of Flutriafol 125 g/l SC 

formulation (Batch Reference Number F-100; Formulation Reference Number YF7440E; 

Purity- 11.9%; cream colored liquid) at a dose of 2000 mg/kg administered by oral gavage. 

Animals were then observed for 14 days.

Oral LD50 Males > 2000 mg/kg

Oral LD50 Females > 2000 mg/kg 

Oral LD50 Combined > 2000 mg/kg 

All animals survived and gained weight. No signs of toxicity were observed. Gross necropsy 

revealed a red area on the lungs of one animal which is not considered to be treatment related. 

Toxicity based on no deaths at the limit dose of 2000 mg/kg. 

This acute oral study is classified as Acceptable. It does satisfy the guideline requirement for an 

acute oral study (OPPTS 870.1100; OECD 401) in the rat. However, OECD 401 is now an 

unacceptable protocol. The preferred protocol is OECD 425: Acute Oral Toxicity-Up-andDown Procedure.

MRID: 47090004

In an acute dermal toxicity study (MRID 47090004), 5/sex of Alpk:APf SD rats (age: 8-12 

weeks; source: Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire, UK 353-397 g 

males and 211-235 g females) were dermally exposed to Flutriafol 125 g/l SC formulation 

(Batch Reference Number F-100; Formulation Reference Number YF7440E; Purity- 11.9%; 

cream colored liquid). Two thousand mg/kg of body weight of the test substance was applied 

evenly to a dose area of approximately 7 cm x 7 cm on the back of each animal. The test sites 

were covered with an occlusive dressing which consisted of a gauze patch covered by a patch of 

plastic film held in position by an adhesive bandage secured with tape. After a period of 24 

hours, the dressings were removed and the sites were cleansed. Animals were then observed for 

14 days.

Dermal LD50 Males > 2000 mg/kg bw 

Dermal LD50 Females > 2000 mg/kg bw 

Dermal LD50 Combined > 2000 mg/kg bw 

Three animals lost weight the first week; all animals except one gained weight by the end of the 

study. There were no signs of systemic toxicity. Erythema was noted at 4/10 dose sites 

resolving by day 3. Desquamation was noted at one site resolving by day 9. No macroscopic 
197

abnormalities were noted at necropsy.

Toxicity based on no deaths at the limit dose. 

This acute dermal study is classified Acceptable. It does satisfy the guideline requirement for an 

acute dermal study (OPPTS 870.1200; OECD 402) in the rat.

MRID: 47090005

In an acute dermal toxicity study (MRID 47090005), 5/sex of Alpk:APf SD rats (age: 8-12 

weeks; source: Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire, UK 340-416 g 

males and 236-276 g females) were dermally exposed to Flutriafol 125 g/l SC formulation 

(Batch Reference Number F-100; Formulation Reference Number YF7440E; Purity- 11.9%; 

cream colored liquid). Four thousand mg/kg of body weight of the test substance was applied 

evenly to a dose area of approximately 7 cm x 7 cm on the back of each animal. The test sites 

were covered with an occlusive dressing which consisted of a gauze patch covered by a patch of 

plastic film held in position by an adhesive bandage secured with tape. After a period of 24 

hours, the dressings were removed and the sites were cleansed. Animals were then observed for 

14 days.

Dermal LD50 Males > 4000 mg/kg bw 

Dermal LD50 Females > 4000 mg/kg bw 

Dermal LD50 Combined > 4000 mg/kg bw 

All animals survived. Three females lost weight the first week; all animals except one gained 

weight by the end of the study. Stains around the nose and/or staining with urine were seen in all 

animals on days 1 or 2. Erythema and/or edema were noted at all dose sites resolving by day 7. 

Desquamation was noted at 9/10 sites resolving by day 14. No macroscopic abnormalities were 

noted at necropsy.

Toxicity based on no deaths at 4000 mg/kg. 

This acute dermal study is classified Acceptable. It does satisfy the guideline requirement for an 

acute dermal study (OPPTS 870.1200; OECD 402) in the rat.

Non-target Beneficial Insects, Acute (OPPTS 850.3020 Honeybee Acute Contact)

An acute contact study using the TGAI is required to establish the toxicity of flutriafol to 

beneficial insects. The preferred test species is honeybees. Results of the test are tabulated below 

(Table F 12). 

Table F12. Acute Contact and Oral Toxicity of Flutriafol Technical to Honeybees

Species % ai LD50/LC50

(μg ai/bee)

Toxicity 

Category*

MRID No. Study 

Classification

Honey bee 93 >50 (contact) Practically nontoxic

47090326

McIntosh and 

Acceptable
198

Table F12. Acute Contact and Oral Toxicity of Flutriafol Technical to Honeybees

>2 (oral) Not categorized

Wilkinson. 

1982. Supplemental †

† Acute oral - a non-guideline study 

* The LD50s were greater than the highest concentration; therefore, it was not possible to calculate a probit 

slope and 95% confidence interval. 

Because the LD50 is greater than 11 μg ai/bee, flutriafol TGAI is categorized as practically nontoxic to honeybees on an acute contact basis. The guideline (OPPTS 850.3020) is fulfilled. 

By 48 hours in the first contact test with flutriafol technical, mortality was 6.7% in the control 

and 0, 13.3, 3.3, 0.0 and 3.3% in the 1.0, 5.0, 10, 20 and 50 μg ai/bee treatment groups, 

respectively; no sub-lethal effects were reported. By 48 hours in the second contact test with 

flutriafol technical, mortality was 0% in the control and 3.3, 0, 3.3, 6.7 and 0% in the 1.0, 5.0, 

10, 20 and 50 μg ai/bee treatment groups, respectively; no sub-lethal effects were reported.

Additional supplemental honeybee oral toxicity test indicates the oral 48-h LC50 for flutriafol is 

>2 μg ai/bee (MRID 47090326). By 48 hours in the first oral test with flutriafol technical, 

mortality was 0% in the control and 6.7% in the single treatment group; no sub-lethal effects 

were reported. By 48 hours in the second oral test with flutriafol technical, mortality was 0% in 

the control and 2.0 μg ai/bee treatment group and no sub-lethal effects were reported. 

Additional Honeybee Toxicity Studies with Formulation Product of Flutriafol

Additional honeybee studies were also submitted by the registrant on the flutriafol formulation 

product, Flutriafol 125 g/l SC. Results are tabulated below (Table F 12a). 

Table F 12a. Acute Toxicity of Formulation Products of Flutriafol to Honeybees

Species % ai Toxicity Value Toxicity 

Category*

MRID No. Study 

Classification

Honey bee

(contact) 12.7

LD50 >52.5 μg ai/bee N/A

47090326A

McIntosh and 

Wilkinson (1982)

Acceptable

LD50 >10.5 μg ai/bee N/A Acceptable

Honey bee

(oral; non-guideline 

study)

LC50 = 47 μg ai/bee N/A Supplemental1

LC50 >50 μg ai/bee N/A Supplemental1

Honey bee

(contact)

12.1

LD50 >1280 μg/bee or 

>1% of sucrose N/A

47090327 B

Kleiner, R (1994)

Acceptable

Honey bee

(oral; non-guideline 

study)

LC50 >198 μg /bee

(>24 μg ai/bee)

N/A Supplemental1

* The LD50s were greater than the highest concentration tested; therefore, it was not possible to calculate a probit 

slope and 95% confidence intervals. 

A Based on SC JF 8496 formulation product

B Based on IMPACT formulation product

1 Not an EPA guideline study

Form = formulation product; ai = active ingredient; N/A = not available
199

Results of LD50s >52.5 μg ai/bee and >1280 μg/bee (or 1% of sucrose) indicate that honeybees 

were not effected to IMPACT or SC JF 8496 formulation products containing flutriafol on an 

acute contact basis. The acute contact studies are scientifically sound and fulfill the OPPTS 

850.3020 guideline requirement for acute toxicity to beneficial insects. 

SC JF 8496 Formulation Product of Flutriafol (MRID: 47090326)

The honeybee, (Apis mellifera), was exposed to SC JF 8496 (formulation containing flutriafol 

Technical) for 48 hours in two oral and two contact tests for a total of four definitive toxicity

tests. In the two contact tests with SC JF 8496, bees were treated with two ranges of 

concentrations. One series with the formulation product of SC JF 8496 was prepared with 

acetone and water that consisted of nominal concentrations of 0 (control), 1.0, 2.1, 5.2 and 10.5 

μg ai/bee. The second series with the formulation product of SC JF 8496 was prepared with 

water only and consisted of nominal concentrations of 0 (control), 5.2, 10.5 and 52.5 μg ai/bee. 

By 48 hours in the first contact test with SC JF 8496, mortality was 0% in the control and 0, 

10.0, 10.0 and 0% in the 1.0, 2.1, 5.2 and 10.5 μg ai/bee treatment groups, respectively; no sublethal effects were reported. In the second contact test with SC JF 8496, mortality was 0% in the 

control and 0, 0 and 3.3% in the 5.2, 10.5 and 52.5 μg ai/bee treatment groups, respectively; no 

sub-lethal effects were observed. By 48 hours in the first oral test with SC JF 8496, mortality

was 3.3% in the control and 10, 3.3, 3.3, 13 and 57% in the 1.0, 5.0, 10, 20 and 50 μg ai/bee 

treatment groups, respectively; no sub-lethal effects were reported. In the second oral test with 

SC JF 8496, mortality was 0% in the control and 3.3, 0, 0, 3.3 and 47% in the 1.0, 5.0, 10, 20 and 

50 μg ai/bee treatment groups, respectively; no sub-lethal effects were reported. The LC50 values 

for the first and second oral tests with SC JF 8496 were 47 and >50 μg ai/bee, respectively. 

The LD50 values for the first and second contact tests with SC JF 8496 were both >10.5 and 

>52.5 μg ai/bee, respectively. As a result, SC JF 8496 is categorized as practically nontoxic at 

concentrations of >10.5 and >52.5 μg ai/bee to honeybee on an acute contact basis. 

IMPACT Formulation Product of Flutriafol (MRID: 47090327)

The honeybee, Apis mellifera L., was exposed to IMPACT (formulation containing the active 

ingredient flutriafol) for 24 hours in the oral test and for 72 hours in the direct contact test. The 

oral nominal concentrations were 0 (control) and 1% of the sucrose feeding solution or 1280 

μg/bee. The actual intake concentration of flutriafol in the single treatment level of the oral 

toxicity test was 198 μg/bee; however, it was not specified is this concentration was based on the 

active ingredient or the formulated product. Additionally, the 1280 μg/bee treatment was used in 

the contact test. By 24 hours in the oral test, mortality was 0% in the control and 3% in the 198 

μg/bee treatment level. By 72 hours in the direct contact test, mortality was 2% in the control 

and 0% in 1280 μg/bee treatment level. No sub-lethal effects were observed in any of definitive 

tests. The LC50 value for the oral test was >198 μg/bee. 

The LD50 value for the direct contact test was >1280 μg/bee. As a result, IMPACT is 

categorized as practically non-toxic at a concentration of 1280 μg/bee to honey bees on an acute 

contact basis. 

Toxicity to Terrestrial Plants 
200

Terrestrial plant testing (seedling emergence and vegetative vigor) is required for fungicides that 

have terrestrial non-residential outdoor use patterns and that may move off the application site 

through volatilization (vapor pressure >1.0 x 10-5mm Hg at 25oC) or drift (aerial or irrigation) 

and/or that may have endangered or threatened plant species associated with the application site. 

For seedling emergence and vegetative vigor testing the following plant species and groups 

should be tested: (1) six species of at least four dicotyledonous families, one species of which is 

soybean (Glycine max) and the second is a root crop, and (2) four species of at least two 

monocotyledonous families, one of which is corn (Zea mays). Tier I tests measure the response 

of plants, relative to a control, at a test level that is equal to the highest use rate (expressed as lbs 

ai/A). 

Terrestrial Plants, Seedling Emergence and Vegetative Vigor

(OPPTS 850.4100 and 850.4150 - Tier I)

Results of Tier I testing are presented in the following table (Table F13): 

Table F13. Nontarget Terrestrial Plant Seedling Emergence and Vegetative Vigor Toxicity (Tier I)1

Species

Seedling emergence Vegetative vigor

Endpoint2 % inhibition Endpoint2 % inhibition

Monocots:

Corn Length 4.8 Length 0.9

Onion Weight 6.9 None -4.2

Ryegrass Emergence 8.8 Weight 17.1

Wheat Length 1.6 Length 0.9

Dicots:

Cabbage Weight 6.1 None -6.5

Lettuce Weight 6.8 None -4.5

Radish Length 2.8 Weight 6.7

Soybean Weight 9.0 Weight 1.8

Sugarbeet Emergence 3.2 Weight 15.1

Tomato None 0.0 None -6.0

1 MRIDs no. 47090328 and 47090329; Porch, Martin, and Krueger (2006); 11.9% ai; application rate = 0.12 lb ai/A

2

only the most sensitive endpoint is tabulated 

Negative % inhibition = growth 

Seedling Emergence (MRID: 47090328)

The effect of Flutriafol 125 g/L SC (formulation containing the active ingredient Flutriafol; 

11.9%) on the seedling emergence of monocot and dicot crops was studied at mean-measured 

application rates of 0 (negative and blank controls) and 0.12 lbs ai/A. The growth medium used 

in the seedling emergence test was natural soil, classified as a sandy loam soil, with a pH of 7.3 

and an organic matter content of 2.2%. Survival, emergence, dry weight and plant height were 

not significantly affected in any of the species tested. The percentage inhibition in seedling 
201

emergence in the treated species as compared to the control ranged from -9.4% to 8.8%. The 

most sensitive monocot species, based on an 8.8% inhibition in emergence relative to the 

negative control, in the seedling emergence test was ryegrass with an EC25 of >0.12 lbs ai/A and 

a NOAEC of ≥0.12 lbs ai/A. The most sensitive dicot species, based on a 9.0% inhibition in dry

weight relative to the negative control, was soybean with an EC25 of >0.12 lbs ai/A and a 

NOAEC of ≥0.12 lbs ai/A. Corn and tomato were the only species to exhibit no compoundrelated phytotoxic effects. There were no clear dose-dependent effects for the remaining species; 

however, slight to severe effects were observed in a few instances and effects included leaf curl, 

necrosis and chlorosis. The guideline (OPPTS 850.4100) is fulfilled (MRID 47090328). A 

seedling emergence multiple-dose (Tier II) test is not required because none of the test species 

were inhibited more than 25% or had a significant effect at the maximum application rate of 0.12 

lb ai/A. 

Vegetative Vigor (MRID: 47090329)

The effect of Flutriafol 125 g/L SC (formulation containing the active ingredient Flutriafol; 

11.9%) on the vegetative vigor of monocot and dicot crops was studied at mean-measured 

application rates of 0 (negative and blank controls) and 0.12 lbs ai/A. The growth medium used 

in the vegetative vigor test was natural soil, classified as a sandy loam soil, with a pH of 7.3 and 

an organic matter content of 2.2%. Ryegrass was the only species in which plant dry weight was 

significantly affected by Flutriafol 125 g/L SC treatment; plant height and survival were not 

significantly affected in any species. The most sensitive monocot, based on a 17.1% inhibition 

in dry weight relative to the negative control, was ryegrass with NOAEC and EC25 values of 

<0.12 and >0.12 lbs ai/A, respectively. The most sensitive dicot, based on a 15.1% inhibition in 

dry weight relative to the negative control, was sugar beet with NOAEC and EC25 values of 

≥0.12 and >0.12 lbs ai/A, respectively. One or more incidental signs of phytotoxicity, such as 

necrosis, chlorosis, leaf curl and mortality were observed, however, these signs were infrequent 

and observed on plants from both the treatment and control groups, and therefore were not 

attributed to treatment. The guideline (OPPTS 850.4150) is fulfilled (MRID 47090329). A 

vegetative vigor multiple-dose (Tier II) test is required for ryegrass because the test species was 

significantly effected at the maximum application rate of 0.12 lb ai/A. All other species were not 

inhibited 25% or more and were not significantly affected at the maximum rate. 

OPPTS 850.4250 – Tier II

Results of Tier II testing with ryegrass are presented in the following table (Table F13a): 

Table F13a. Summary of Tier II Vegetative Vigor Results for Flutriafol 125 g/L SC with Ryegrass*

Species EC50

(lb ai/A)

EC25

(lb ai/A)

NOAEC 

(lb ai/A)

Affected 

endpoints

MRID no.

Author/Year

Study 

classification

Ryegrass >0.26 >0.26 0.26 None 

47689801

Porch, Martin, and 

Krueger. 2009.

Acceptable

* 11.9% flutriafol, tested at the maximum application rate of 0.26 lb ai/A
202

Vegetative Vigor (MRID 47689801)

The effects of Flutriafol 125 g/L SC (AI: Flutriafol) on the vegetative vigor of the monocot 

ryegrass (Lolium perenne) was studied at nominal concentrations of 0 (negative control), 8.40, 

16.8, 33.5, 67.0, 134, and 268 g ai/ha, which were equivalent to 0 (negative control), 0.0075, 

0.015, 0.030, 0.060, 0.12, and 0.24 lbs ai/A. Measured concentrations were <LOQ (<0.000002, 

negative control), 0.0081, 0.016, 0.032, 0.064, 0.13, and 0.26 lbs ai/A. The growth medium used 

in the vegetative vigor test was a mixture of artificial and natural soil, representing a sandy loam, 

with 1.0% organic carbon, and a pH of 6.2. On Day 21 the surviving plants per pot were 

measured, recorded and cut for determining the plant dry weight and height. There was no 

inhibition in survival in ryegrass. The study author’s results indicated that the level of inhibition 

in plant height and dry weight was very low as compared to the control mean (range: 1-8% and 

0-11%, respectively) and no clear dose-response relationship was evident. No phytotoxic effects 

were observed. There were no sensitive endpoints for ryegrass, resulting in overall NOAEC, 

LOAEC, and EC25 values of 0.26, >0.26, and >0.26 lbs ai/A, respectively.
203

Appendix G. Flutriafol Ecological Effects Bibliography

Ecological Effects MRID Studies Submitted to EPA

Guideline: OPPTS 850.2100 Avian Single Dose Oral Toxicity

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

MRID: 47090318 (old MRID: 163464)

Roberts, N.; Fairley, C. 1982. The Acute Oral Toxicity (LD50) of PP450 to the Mallard Duck. Unpublished study 

performed by Huntingdon Life Sciences, Ltd., Huntingdon, Cambridgeshire, UK. Laboratory Study No. 

ICI/419/82559. Study sponsored by Imperial Chemical Industries PLC and submitted by Cheminova, Inc., 

Arlington, VA. Study completed on August 13, 1982. 22 pages.

MRID: 47090319

Roberts, N.; Fairley, C. 1982. The Acute Oral Toxicity (LD50) of PP450 to the Red-Legged Partridge. Unpublished 

study performed by Huntingdon Life Sciences, Ltd., Huntingdon, Cambridgeshire, UK. Laboratory Study No. ICI 

420/82808. Study sponsored by Imperial Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, 

VA. Study submitted on November 4, 1982. 26 pages. 

MRID: 47471301

Hubbard, P.; Beavers, J. 2008. Flutriafol: An Acute Oral Toxicity Study with the Northern bobwhite. Unpublished 

study performed by Wildlife International, Ltd., Easton, MD. Laboratory Study No. 232/138. Study sponsored by 

Imperial Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, VA. Study submitted on May 8, 

2008. 74 pages.

Guideline: OPPTS 850.2300 Avian Dietary Toxicity

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

MRID: 47090320 (old MRID: 163465)

Roberts, N.; Fairley, C.; Almond, R. 1982. The Subacute Dietary Toxicity (LD50) of PP450 to the Mallard Duck. 

Unpublished study performed by Huntingdon Life Sciences, Ltd., Huntingdon, Cambridgeshire, UK. Laboratory 

Study No. ICI 421 WL/82630. Study sponsored by Imperial Chemical Industries PLC and submitted by Cheminova, 

Inc., Arlington, VA. Study submitted on November 26, 1982. 34 pages.

MRID: 47090321 (old MRID: 163680)

Roberts, N., et al. 1986. The Subacute Dietary Toxicity of Flutriafol to the Bobwhite Quail. Unpublished study 

performed by Huntingdon Life Sciences, Ltd., Huntingdon, Cambridgeshire, UK. Laboratory Study No. ISN 

79BT/86200/2. Study sponsored by Imperial Chemical Industries PLC and submitted by Cheminova, Inc., 

Arlington, VA. Study submitted on August 6, 1986. 27 pages. 

Guideline OPPTS 850.2300 Avian Reproduction 

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

MRID: 47090322

Temple, D.; Frey, L.; Beaver, J.; et al. 2007. Flutriafol: A Reproduction Study with the Mallard. Unpublished study 

performed by Wildlife International Ltd., Easton, MD. Laboratory Study No. 232-127. Study sponsored and 

submitted by Cheminova A/S, Lemvig, Denmark. Study submitted on March 7, 2007. 227 pages.

MRID: 47090323

Thompson, H.M. 2007. Flutriafol: Assessment to Determine the Effects on Reproduction in the Bobwhite Quail 

(Colinus virginianus). Unpublished study performed by Environmental Risk Assessment Team, Environmental 

Biology Group, Central Science Laboratory, York, UK. Laboratory Study No. K3AQ1001. Study submitted by 

Cheminova A/S, Lemvig, Denmark. Study initiated September 18, 2002, completed on August 3 2007 and 

originally submitted January 23, 2004. Amended report submitted March 2007. 174 pages.
204

MRID: 47090324

Reiss, R. 2007. Analysis of Hatchling Survival in a Bobwhite Quail Reproduction Study for Flutriafol. 

Unpublished study performed by Exponent, Alexandria, VA. Study sponsored by Cheminova A/S, Lemvig, 

Denmark, and submitted by Cheminova, Inc., Arlington, VA on March 20, 2007. 17 pages.

Guideline OPPTS 850.1075 Freshwater and Saltwater Fish Acute Toxicity

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

MRID: 47090308

Palmer, S.J., C.A. Sutherland, T.Z. Kendall and H.O. Krueger. 2006. Flutriafol: A 96-Hour Static Acute Toxicity 

with the Sheepshead Minnow (Cyprinodon variegatus). Unpublished study performed by Wildlife International, 

Ltd., Easton, Maryland. Laboratory report number 232A-106. Study sponsored by Cheminova A/S, Lemvig, 

Denmark. Study completed November 21, 2006. 64 pages

MRID: 47090309

Palmer, Susan J., C.A. Sutherland, T.Z. Kendall, and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A 96-Hour Static 

Acute Toxicity Test with the Bluegill (Lepomis macrochirus). Unpublished study performed by Wildlife 

International, Ltd., Easton, MD. Laboratory report number 232A-105. Study sponsored by Cheminova A/S, 

Lemvig, Denmark. Study completed November 22, 2006. 64 pages.

MRID: 47090310 (old MRID: 163467)

Hill, R.W. 1985. Flutriafol: Determination of Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus). 

Unpublished study performed by Imperial Chemical Industries PLC, Brixham, Devon, TQ5 8BA. Laboratory report 

number BL/B2684. Study sponsored by Imperial Chemical Industries, PLC and submitted by Cheminova A/S, 

Arlington, VA. Study completed August 19, 1985. 15 pages.

MRID: 47090311 (old MRID: 163466)

Hill, R.W. 1982. PP450: Determination of the Acute Toxicity to Rainbow Trout (Salmo gairdneri). Unpublished 

study performed by Imperial Chemical Industries PLC, Brixham, Devon TQ5 8BA. Laboratory report number 

J013/B. Study sponsored by Imperial Chemical Industries PLC and submitted by Cheminova, Inc., Arlington, VA. 

Study completed August 18, 1982. 21 pages.

MRID: 47090312

Sankey, S.A. 1993. Flutriafol: Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) of a 125 g/L SC 

Formulation. Unpublished study performed by Brixham Environmental Laboratory, Brixham, Devon, TQ5 8BA, 

U.K. Laboratory report number BL4646/B. Study sponsored by Zeneca Agrochemicals, Surrey GU27 3JE, U.K. 

and submitted by Cheminova, Inc., Arlington, VA. Study completed April 14, 1993. 24 pages.

Guideline OPPTS 850.1010 Freshwater Invertebrate Acute Toxicity

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

MRID: 47090304 (old MRID: 163468)

Hamer, M.J. and I.R. Hill. 1982. PP450: Toxicity to First Instar Daphnia magna. Unpublished study performed by 

Imperial Chemical Industries, Plant Protection Division, Jealotts Hill Research Station, Bracknell, Berkshire RG 12 

6EY. Laboratory report number RJ 0264B. Study sponsored by Imperical Chemical Industries and submitted by 

Cheminova, Inc., Arlington, VA. Study completed September 14, 1982. 13 pages.

MRID: 47090305

Kent, S.J. 1994. Flutriafol: Acute Toxicity to Daphnia magna of a 125 g/L SC Formulation. Unpublished study 

performed by Brixham Environmental Laboratory, Brixham, Devon TQ5 8BA, U.K. Laboratory report number 

BL5240/B. Study sponsored by Zeneca Agrochemicals, Fernhurst Haslmere, Surrey GU 27 3JE, U.K. and 

submitted by Cheminova, Inc., Arlington, VA. Study completed December 13, 1994. 25 pages.
205

Guideline OPPTS 850.1025 Estuarine/Marine Mollusk Toxicity (Shell Deposition)

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

MRID: 47090306

Palmer, S.; Sutherland, C.; Kendall, T.; Krueger, H. 2006. Flutriafol: A 96-Hour Shell Deposition Test with Eastern 

Oyster (Crassostrea virginica). Unpublished study performed by Wildlife International, Ltd., Easton, MD. 

Laboratory report no. 232A-108. Study sponsored and submitted by Cheminova A/S, Lemvig, Denmark. Study 

completed November 21, 2006. 62 pages.

Guideline OPPTS 850.1035 Estuarine/Marine Invertebrate Toxicity

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

MRID: 47090307

Palmer, S.; Sutherland, C.; Kendall, T.; Krueger, H. 2006. Flutriafol: A 96-Hour Static Acute Toxicity Test with the 

Saltwater Mysid (Americamysis bahia). Unpublished study performed by Wildlife International, Ltd., Easton, MD. 

Laboratory report no. 232A-107. Study sponsored and submitted by Cheminova A/S, Lemvig, Denmark. Study 

completed November 21, 2006. 63 pages.

Guideline OPPTS 850.1300 Freshwater Aquatic Invertebrate Life Cycle

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

MRID: 47090314

Williams, B.R.H., et al. 1990. Flutriafol: Determination of Chronic Toxicity to Daphnia magna. Unpublished 

study performed by Imperial Chemical Industries PLC, Brixham, Devon, UK. Laboratory Report No. BL3840/B. 

Study sponsored by ICI Agrochemicals, Fernhurst, Haslemere, Surry, UK, and submitted by Cheminova, Inc., 

Arlington, VA. Study initiated April 30, 1990 and submitted August 30, 1990. 24 pages.

 

MRID: 47090315

Bätscher, R. 2004. Influence of Flutriafol Technical on Survival and Reproduction of Daphnia Magna in a SemiStatic Test over Three Weeks. Unpublished study performed by RCC Ltd., Itingen, Switzerland. Laboratory Report 

No. 847686. Study sponsored and submitted by Cheminova, Inc., Arlington, VA. Study initiated September 16, 

2003 and submitted March 25, 2004. 70 pages.

MRID: 47090316

Bätscher, R. 2004. Influence of CHA 1310-03 on Survival and Reproduction of Daphnia Magna in a Semi-Static 

Test over Three Weeks. Unpublished study performed by RCC Ltd., Itingen, Switzerland. Laboratory Report No. 

847692. Study sponsored and submitted by Cheminova, Inc., Arlington, VA. Study initiated September 16, 2003 

and submitted March 25, 2004. 70 pages.

Guideline OPPTS 850.1400 Freshwater Fish Early-Life Stage

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

MRID: 47090317

Palmer, S.J., T.Z. Kendall, and H.O. Krueger. 2007. Flutriafol: An Early Life-Stage Toxicity Test with the Fathead 

Minnow (Pimephales promelas). Unpublished study performed by Wildlife International., Ltd., Easton, MD. 

Laboratory Project No. 232A-109. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study initiated August 

24, 2006 and submitted February 1, 2007. 101 pages. 

Guideline OPPTS 850.3020 Honeybee Acute Contact Toxicity

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

MRID: 47090326

McIntosh, S.; Wilkinson, W. 1982. PP450 (Flutriafol Technical and End-Use Formulation): Acute Oral and Contact 

Toxicity to Honey Bees. Unpublished study performed by Imperial Chemical Industries PLC, Bracknell, Berkshire, 

RG12 6EY. Laboratory Project Identification No. RJ0277B. Study sponsored by Imperial Chemical Industries PLC, 

Bracknell, Berkshire, England, and submitted by Cheminova, Inc., Arlington, VA. Study completed September 21 

1982. 22 pages.
206

MRID: 47090327

Kleiner, R. 1994. Testing Toxicity to Honeybee-Apis mellifera L. (Laboratory) According to BBA Guideline VI, 23-

1 1991. Unpublished study performed by BioChem GmbH, Karlsruhe, Germany. Laboratory Project No. 94 10 48 

037. Study sponsored by Zeneca Agro, Emil-von-Behring –Str. 2, 60439 Frankfurt/M, Germany and submitted by 

Cheminova, Inc., Arlington, VA. Study completed Aug 18 1994. 19 pages. 

Guideline OPPTS 850.4100 Seedling Emergence

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

MRID: 47090328

Porch, J.R., K.H. Martin and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A Toxicity Test to Determine the Effects 

of the Test Substance on Seedling Emergence of Ten Species of Plants. Unpublished study performed by Wildlife 

International, Ltd., Easton, MD. Laboratory Report No. 232-133. Study sponsored and submitted by Cheminova 

A/S, Lemvig, Denmark. Study completed November 13, 2006. 86 pages. 

Guideline OPPTS 850.4150 Vegetative Vigor

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

MRID: 47090329

Porch, J.R., K.H. Martin and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A Toxicity Test to Determine the Effects 

of the Test Substance on Vegetative Vigor of Ten Species of Plants. Unpublished study performed by Wildlife 

International, Ltd., Easton, MD. Laboratory Report No. 232-134. Study sponsored and submitted by Cheminova 

A/S, Lemvig, Denmark. Study completed November 13, 2006. 106 pages. 

Guideline OPPTS 850.4250 Vegetative Vigor

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

MRID: 47689801

Porch, J.R., Krueger, H.O., and Martin, K.H. 2009. Flutriafol 125 g/L SC: A Toxicity Test to Determine the Effects 

of the Test Substance on Vegetative Vigor of Ryegrass. Unpublished study performed by Wildlife International, 

Ltd., Easton, Maryland. Laboratory Project No.: 232-147. Study sponsored by Cheminova A/S, Denmark. Study 

completed February 26, 2009.

Guideline OPPTS 850.4400 Aquatic Vascular Plant Toxicity

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

MRID: 47090330

Desjardins, D., T.Z. Kendall and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A 7-Day Toxicity Test with 

Duckweed (Lemna gibba G3). Unpublished study performed by Wildlife International, Ltd., Easton, MD. 

Laboratory report number 232A-110. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study completed 

December 21, 2006. 71 pages.

Guideline OPPTS 850.5400 Algal Plant Toxicity

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

MRID: 47090331

Desjardins, D., T.Z. Kendall and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A 96-Hour Toxicity Test with the 

Marine Diatom (Skeletonema costatum). Unpublished study performed by Wildlife International, Ltd., Easton, MD. 

Laboratory report number 232A-113. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study completed 

December 21, 2006. 73 pages.

MRID: 47090332

Desjardins, D., T.Z. Kendall and H.O. Krueger. 2006. Flutriafol 125 g/L SC: A 96-Hour Toxicity Test with the 

Freshwater Diatom (Navicula pelliculosa). Unpublished study performed by Wildlife International, Ltd., Easton, 

MD. Laboratory report number 232A-112. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study 

completed December 21, 2006. 74 pages.
207

MRID: 47090333

Desjardins, D., T.Z. Kendall and H.O. Krueger. 2007. Flutriafol 125 g/L SC: A 96-Hour Toxicity Test with the 

Freshwater Alga (Pseudokirchneriella subcapitata). Unpublished study performed by Wildlife International, Ltd., 

Easton, MD. Laboratory report number 232A-111. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study 

completed January 15, 2007. 74 pages.

MRID: 47090334

Desjardins, D., T.Z. Kendall and H.O. Krueger. 2007. Flutriafol 125 g/L SC: A 96-Hour Toxicity Test with the 

Freshwater Alga (Anabaena flos-aquae). Unpublished study performed by Wildlife International, Ltd., Easton, MD. 

Laboratory report number 232A-114. Study sponsored by Cheminova A/S, Lemvig, Denmark. Study completed 

January 15, 2007. 72 pages.

Non-guideline Studies

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

MRID: 47090303

Hawkins, D.R., et al. 1987. Accumulation and Depletion of radioactive Residues in the Tissues of Mallard Duck and 

Bobwhite Quail Following Oral Doses of 14C-Flutriafol. Unpublished study performed by Huntingdon Research 

Centre Ltd., Huntingdon, Cambridgeshire, England. Laboratory Project No. ISN 138/87956. Study sponsored by 

Imperial Chemical Industries PLC, Bracknell, Berkshire, England, and submitted by Cheminova, Inc., Arlington, 

VA. Study submitted on August 12, 1987. 44 pages. 
208

Appendix H. Environmental Fate Bibliography

Hydrolysis 

Hawkins, D.R., L.F. Elsom, and R. Jackson. 1987. PP450: a hydrolysis study in aqueous 

solution at pH 5, 7, and 9. Unpublished study performed by Huntingdon Research Centre Ltd., 

Cambridgeshire, United Kingdom (p.22); sponsored by Imperial Chemical Industries PLC 

(location not reported); and submitted by Cheminova, Inc., Arlington, Virginia. Report No.: 

HRC/ISN 136/87510. Experimental start date March 3, 1987 and completion date April 16, 

1987 (p.12). Final report issued June 10, 1987. MRID 47090416

Aqueous Photolysis

Skidmore, M.W. 1987. Flutriafol: a photolysis study in aqueous solution at pH 7. Unpublished 

study performed by Huntingdon Research Centre Ltd., Cambridgeshire, England (pp.8, 13); 

sponsored by ICI PLC Plant Protection Division, Jealott’s Hill Research Station, Berkshire, 

England; and submitted by Cheminova Inc., Arlington, Virginia. Study Number: PP450AG03. 

Report No.: RJ 0607B. Experimental start April 13, 1987 and completion June 16, 1987 

(Appendix A, p.24). Final report issued December 9, 1987. MRID 47090417

Moffatt, F. 1994. Flutriafol: environmental half-life and quantum yield for direct 

phototransformation in aqueous solution. Unpublished study performed and sponsored by

Zeneca Agrochemicals, Bracknell, Berkshire; and submitted by Cheminova Inc., Arlington, 

Virginia. Study Number: 93JH187. Report No.: RJ 1581B. Experimental start August 1993 and 

completion December 1993 (p.10). Final report issued January 27, 1994. MRID 47090418

Soil Photolysis

Snow, A.D. and B.D. Cavell. 1982. PP450: photolysis on a soil surface. Unpublished study

performed and sponsored by ICI PLC Plant Protection Division, Jealott’s Hill Research Station, 

Berkshire, England; and submitted by Cheminova Inc., Arlington, Virginia. Report No.: RJ 

0289B. Experimental start and completion dates not reported. Final report issued December 16, 

1982. MRID 47090420

Hiler, T., and A. Lopez. 2008. Photodegradation of [14C]flutriafol in/on soil by artificial light. 

Unpublished study performed by PTRL West, Inc., Hercules, California. Study sponsored and 

submitted by Cheminova A/S, Lemvig, Denmark. PTRL Report No.: 1719W-1. PTRL Project 

No.: 1719W. Experiment started January 8, 2008 and completed February 9, 2008 (p. 15). Final 

report issued April 21, 2008. MRID 47418401

Aerobic Soil Metabolism 

Hiler, T. 2006. Aerobic soil metabolism of [14C]flutriafol. Unpublished study performed by

PTRL West, Inc., Hercules, California; sponsored by Cheminova A/S, Lemvig, Denmark; and 

submitted by Cheminova, Inc., Arlington, Virginia. PTRL West Study No.: 1351W and Report 

No.: 1351W-1. Experiment started March 25, 2005; a completion date was not reported (p.12). 
209

Final report issued September 20, 2006. MRID 47090421

Vincent, J., B.R. Harvey, D.J. Arnold and I.R. Hill. 1982. PP450: degradation in laboratory

incubated soils. Unpublished study performed by ICI Plant Protection Division, Berkshire, 

England. Sponsored by Imperial Chemical Industries PLC and submitted by Cheminova, Inc., 

Arlington, Virginia. Laboratory Report No.: RJ 0287B. The experiment initiation and 

completion dates were not reported. Final report issued November 26, 1982. MRID 47090422

Swaine, H., A. Sapiets and S. Robertson. 1982. PP450: Laboratory study of the degradation in 

two German Standard Soils and a United Kingdom soil. Unpublished study performed by ICI

Plant Protection Division, Berkshire, United Kingdom; sponsored by Imperial Chemical 

Industries PLC (ICI agrochemicals are now part of AstraZeneca) and submitted by Cheminova, 

Inc., Arlington, Virginia. Laboratory Report No.: RJ 0297B. The experiment start and 

completion dates were not reported. Final report issued December 17, 1982. MRID 47090423

Anaerobic Soil Metabolism

Hiler, T. 2006. Anaerobic aquatic metabolism of [14C]flutriafol. Unpublished study performed 

by PTRL West, Inc., Hercules, California (p.1); sponsored by Cheminova A/S, Lemvig, 

Denmark; and submitted by Cheminova, Inc., Arlington, Virginia. PTRL Study No.: 1352W and 

Report No.: 1352W-1. Experimental start date May 17, 2005 and completion date June 1, 2006 

(Table II, p.33). Final report issued September 20, 2006. MRID 47090424

Aerobic Aquatic Metabolism

Waring, A.R. and P. Yeomans. 1993. (14C)-Flutriafol: the degradation in water/sediment 

systems. Unpublished study performed by Hazelton Europe, North Yorkshire, United Kingdom; 

sponsored by Zeneca Agrochemicals, Berkshire, United Kingdom; and submitted by Cheminova, 

Inc., Arlington, Virginia. Hazelton Report No.: 38/178-1015 (p.1). Experimental start date 

March 22, 1993, and completion date September 22, 1993 ("practical phase" of study; p.13). 

Final report issued November 9, 1993 . MRID 47090419

Adsorption/Desorption 

Hiler, T. 2006. Soil adsorption/desorption of [14C]flutriafol by the batch equilibrium method. 

Unpublished study performed by PTRL West, Inc., Hercules, California; and sponsored and 

submitted by Cheminova A/S, Lemvig, Denmark. PTRL West Project Number: 1353W and 

PTRL West Report Number: 1353W-1. Experimental start date May 18, 2005, and completion 

date June 28, 2005 (p.11). Final report issued May 17, 2006. MRID 47090425

Völkel, W. 2004. Adsorption/desorption of 14C-flutriafol on two soils. Unpublished study

performed by RCC Ltd., Itingen, Switzerland; sponsored by Cheminova A/S, Lemvig, Denmark; 

and submitted by Cheminova Inc., Arlington,Virginia. Laboratory Report Number: 847624 and 

CHA Doc. No.: 1105 FLU. Experimental start date June 19, 2003, and completion date 

September 16, 2003 (p.12). Final report issued March 4, 2004. MRID 47090426
210

Schneider, M. and M.W. Hatfield. 1989. Flutriafol: Adsorption and desorption equilibria in 

soil. Unpublished study performed by ICI Agrochemicals, Bracknell, Berkshire, England; 

sponsored by Imperial Chemical Industries PLC, location information not reported; and 

submitted by Cheminova Inc., Arlington,Virginia. Laboratory Report Number: RJ 0759B and 

Laboratory Study No.: 89JH100. Experimental start and completion dates were not reported. 

Final report issued November 21, 1989. MRID 47090427

Lane, M.C.G and D. Rowe (p.4). 1991. Flutriafol: effect of time on adsorption properties in 

soil. Unpublished study performed and sponsored by ICI Agrochemicals, Jealott’s Hill Research 

Station, Berkshire, United Kingdom and submitted by Cheminova, Inc., Arlington, Virginia. 

Report No.: RJ 1057B. Study No.: 91JH115. Experimental initiation and completion dates were 

not provided. Final report issued December 17, 1991 (p.4). MRID 47090428

Adam, D. 2006. [14C]-Flutriafol: time dependent sorption in four soils. Unpublished study

performed by RCC Ltd, Itingen, Switzerland; and sponsored and submitted by Cheminova A/S, 

Lemvig, Denmark. RCC Study Number: A38553 and CHA Document Number: 1371 FLU. 

Experimental start date November 16, 2005, and completion date November 6, 2006 (p. 13). 

Final report issued December 6, 2006. MRID 47345401

Bioconcentration in Fish

Hamer, M.J. and I.R. Hill. 1982. PP450: Accumulation in bluegill sunfish in a flow-through 

system. Unpublished study performed and sponsored by Imperial Chemical Industries PLC, 

Berkshire, United Kingdom; and submitted by Cheminova, Inc., Arlington, Virginia. Laboratory

Report No.: RJ 0286B. CHA Document No.: 427 FLU. Experimental start and completion dates 

were not reported. Final report issued November 5, 1982. MRID 47090437

Terrestrial Field Dissipation

Harvey, B. et al. 1987. Flutriafol: fate of radiolabelled material under field conditions. 

Unpublished study performed by ICI Plant Protection Division Jealott's Hill Research Station, 

Berkshire, United Kingdom; sponsored by Imperial Chemical Industries PLC; and submitted by

Cheminova, Inc., Arlington, Virginia. ICI Report No.: RJ 0524B. Experimental start (initial 

application) date April 23, 1982 (p.14); completion date not reported. Final report issued June 

23, 1987. MRID 47090429

Atreya, N.C. 1991. Flutriafol: Dissipation in soil from studies in Germany (1982-1988). 

Unpublished study performed by ICI Plant Protection Division, Bracknell, Berkshire, United 

Kingdom (performing laboratory) and submitted by Cheminova, Inc., Arlington, Virginia. 

Laboratory Report No.: RJ1081B. CHA Doc No.: 187 FLU. Experiment initiation February 19, 

1982 and completion September 21, 1988 (field phase; Tables 1-6, pp.12-17). Final report issued 

December 19, 1991. MRID 47090431

Atreya, N.C. and J.P. Dick. 1988. Flutriafol: Dissipation in soil from studies in France (1982-

1986). Unpublished study performed by ICI Plant Protection Division, Bracknell, Berkshire, 

France (performing laboratory) and submitted by Cheminova, Inc., Arlington, Virginia. 
211

Laboratory Report No.: M4745B. CHA Doc No.: 188 FLU. Experiment initiation April 6, 1982 

and completion August 21, 1986 (field phase; Tables 1-3, pp.8-9). Final report issued July 1, 

1988. MRID 47090432

Atreya, N. C. and J. P. Dick. 1988. Flutriafol: Residue levels in soil from annual application to 

cereals in West Germany (1982-1986). Unpublished study performed by ICI Plant Protection 

Division, Bracknell, Berkshire, United Kingdom (performing laboratory) and submitted by

Cheminova, Inc., Arlington, Virginia. Laboratory Report No.: M4747B. Laboratory Study No.: 

PP450BD04. CHA Doc No.: 199 FLU. Experiment initiation May 14, 1982 and completion June 

17, 1986 (field phase; Tables 1-6, pp.9-14). Final report issued July 1, 1988. MRID 47090433

Atreya, N.C. and G.S. Davy. 1993. Flutriafol: Residue levels in soil from annual application to 

cereals in France (1982-1989). Unpublished study performed by Zeneca Agrochemicals, 

Bracknell, Berkshire, United Kingdom (performing laboratory) and submitted by Cheminova, 

Inc., Arlington, Virginia. Laboratory Report No.: TMJ3131B. Laboratory Study No.: 

PP450BD04. CHA Doc No.: 204 FLU. Experiment initiation May 13, 1982 and completion June 

28, 1989 (field phase; Tables 1-4, pp.11-14). Final report issued July 1, 1993. MRID 47090434

Atreya, N.C. 1991. Flutriafol: Residue levels in soil from annual application to cereals in the 

United Kingdom (1982-1990). Unpublished study performed by ICI Agrochemicals, Bracknell, 

Berkshire, United Kingdom (performing laboratory) and submitted by Cheminova, Inc., 

Arlington, Virginia. Laboratory Report No.: RJ 1079B. Laboratory Study No.: PP450BD04. 

CHA Doc No.: 208 FLU. Experiment initiation May 24, 1982 and completion June 27, 1990 

(field phase; Tables 1-6, pp.1``2-17). Final report issued December 19, 1991. MRID 47090435

Atreya, N.C. and D.W. Bewick. 1991. Flutriafol: Dissipation in soil from studies in the United 

Kingdom (1982-1990). Unpublished study performed by ICI Agrochemicals, Bracknell, 

Berkshire, United Kingdom (performing laboratory) and submitted by Cheminova, Inc., 

Arlington, Virginia. Laboratory Report No.: RJ 1080B. CHA Doc No.: 185 FLU. Experiment 

initiation March 26, 1982 and completion August 13, 1990 (field phase; Tables 1-3, pp.11-12). 

Final report issued December 19, 1991. MRID 47115502

Non-Guideline

Jarvis, T. 2007. Evaluation of flutriafol degradation kinetics from existing soil and 

water/sediment degradation studies. Unpublished study performed by Exponent International 

Ltd., Yorkshire, United Kingdom; sponsored by Cheminova A/S, Denmark; and submitted by

Cheminova, Inc., Arlington, Virginia. Laboratory Project No.: CH12403; Document No.: 1129. 

Experimental start and completion date were not available. Final report submitted March 15, 

2007. MRID 47090436
212
213

Appendices I, J, K, and L. Direct and Indirect Effects Endangered Species 

Analysis for Apples and Soybeans

The endangered species analysis appendices can be found on the flutriafol compact disc.
214

APPENDIX M

PRZM Input File for Runoff, Erosion, Leaching Assessment 

MS soybean; 8/9/01 

"Yazoo County; MLRA 134; Metfile: W03940.dvf (old: Met131.met)," 

*** Record 3:

 0.75 0.36 0 25 1 3

*** Record 6 -- ERFLAG

 4

*** Record 7:

 0.42 0.3 1 10 3 2 356.8

*** Record 8

 1

*** Record 9

 1 0.2 30 100 3 87 84 87 0 76

*** Record 9a-e

 1 27

1604 2004 0105 0505 1605 0106 1606 0107 1607 0108 1608 0109 1609 0110 1510 1610 

.498 .575 .627 .654 .620 .484 .361 .220 .094 .109 .110 .046 .053 .040 .203 .239 

.014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 

 84 84 84 84 84 84 84 84 84 84 84 84 84 84 87 87

0111 1611 0112 1612 0101 1601 0102 1602 0103 1603 0104 

.316 .394 .464 .524 .245 .276 .306 .337 .373 .418 .468 

.014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 

 87 87 87 87 87 87 87 87 87 87 87

*** Record 10 -- NCPDS, the number of cropping periods

 30

*** Record 11

 160461 010961 101061 1

 160462 010962 101062 1

 160463 010963 101063 1

 160464 010964 101064 1

 160465 010965 101065 1

 160466 010966 101066 1

 160467 010967 101067 1

 160468 010968 101068 1

 160469 010969 101069 1

 160470 010970 101070 1

 160471 010971 101071 1

 160472 010972 101072 1

 160473 010973 101073 1

 160474 010974 101074 1

 160475 010975 101075 1

 160476 010976 101076 1

 160477 010977 101077 1

 160478 010978 101078 1

 160479 010979 101079 1

 160480 010980 101080 1

 160481 010981 101081 1

 160482 010982 101082 1

 160483 010983 101083 1

 160484 010984 101084 1

 160485 010985 101085 1

 160486 010986 101086 1

 160487 010987 101087 1

 160488 010988 101088 1

 160489 010989 101089 1

 160490 010990 101090 1

*** Record 12 -- PTITLE

Flutriafol - 3 applications @ 0.0672 0.0672 0.0672 kg/ha 

*** Record 13

 90 1 0 0

*** Record 15 -- PSTNAM

Flutriafol

*** Record 16

 010661 0 2 0.00.0672 .95 .05

 150661 0 2 0.00.0672 .95 .05

 290661 0 2 0.00.0672 .95 .05

 010662 0 2 0.00.0672 .95 .05

 150662 0 2 0.00.0672 .95 .05

 290662 0 2 0.00.0672 .95 .05
215

 010663 0 2 0.00.0672 .95 .05

 150663 0 2 0.00.0672 .95 .05

 290663 0 2 0.00.0672 .95 .05

 010664 0 2 0.00.0672 .95 .05

 150664 0 2 0.00.0672 .95 .05

 290664 0 2 0.00.0672 .95 .05

 010665 0 2 0.00.0672 .95 .05

 150665 0 2 0.00.0672 .95 .05

 290665 0 2 0.00.0672 .95 .05

 010666 0 2 0.00.0672 .95 .05

 150666 0 2 0.00.0672 .95 .05

 290666 0 2 0.00.0672 .95 .05

 010667 0 2 0.00.0672 .95 .05

 150667 0 2 0.00.0672 .95 .05

 290667 0 2 0.00.0672 .95 .05

 010668 0 2 0.00.0672 .95 .05

 150668 0 2 0.00.0672 .95 .05

 290668 0 2 0.00.0672 .95 .05

 010669 0 2 0.00.0672 .95 .05

 150669 0 2 0.00.0672 .95 .05

 290669 0 2 0.00.0672 .95 .05

 010670 0 2 0.00.0672 .95 .05

 150670 0 2 0.00.0672 .95 .05

 290670 0 2 0.00.0672 .95 .05

 010671 0 2 0.00.0672 .95 .05

 150671 0 2 0.00.0672 .95 .05

 290671 0 2 0.00.0672 .95 .05

 010672 0 2 0.00.0672 .95 .05

 150672 0 2 0.00.0672 .95 .05

 290672 0 2 0.00.0672 .95 .05

 010673 0 2 0.00.0672 .95 .05

 150673 0 2 0.00.0672 .95 .05

 290673 0 2 0.00.0672 .95 .05

 010674 0 2 0.00.0672 .95 .05

 150674 0 2 0.00.0672 .95 .05

 290674 0 2 0.00.0672 .95 .05

 010675 0 2 0.00.0672 .95 .05

 150675 0 2 0.00.0672 .95 .05

 290675 0 2 0.00.0672 .95 .05

 010676 0 2 0.00.0672 .95 .05

 150676 0 2 0.00.0672 .95 .05

 290676 0 2 0.00.0672 .95 .05

 010677 0 2 0.00.0672 .95 .05

 150677 0 2 0.00.0672 .95 .05

 290677 0 2 0.00.0672 .95 .05

 010678 0 2 0.00.0672 .95 .05

 150678 0 2 0.00.0672 .95 .05

 290678 0 2 0.00.0672 .95 .05

 010679 0 2 0.00.0672 .95 .05

 150679 0 2 0.00.0672 .95 .05

 290679 0 2 0.00.0672 .95 .05

 010680 0 2 0.00.0672 .95 .05

 150680 0 2 0.00.0672 .95 .05

 290680 0 2 0.00.0672 .95 .05

 010681 0 2 0.00.0672 .95 .05

 150681 0 2 0.00.0672 .95 .05

 290681 0 2 0.00.0672 .95 .05

 010682 0 2 0.00.0672 .95 .05

 150682 0 2 0.00.0672 .95 .05

 290682 0 2 0.00.0672 .95 .05

 010683 0 2 0.00.0672 .95 .05

 150683 0 2 0.00.0672 .95 .05

 290683 0 2 0.00.0672 .95 .05

 010684 0 2 0.00.0672 .95 .05

 150684 0 2 0.00.0672 .95 .05

 290684 0 2 0.00.0672 .95 .05

 010685 0 2 0.00.0672 .95 .05

 150685 0 2 0.00.0672 .95 .05

 290685 0 2 0.00.0672 .95 .05

 010686 0 2 0.00.0672 .95 .05

 150686 0 2 0.00.0672 .95 .05

 290686 0 2 0.00.0672 .95 .05

 010687 0 2 0.00.0672 .95 .05

 150687 0 2 0.00.0672 .95 .05

 290687 0 2 0.00.0672 .95 .05
216

 010688 0 2 0.00.0672 .95 .05

 150688 0 2 0.00.0672 .95 .05

 290688 0 2 0.00.0672 .95 .05

 010689 0 2 0.00.0672 .95 .05

 150689 0 2 0.00.0672 .95 .05

 290689 0 2 0.00.0672 .95 .05

 010690 0 2 0.00.0672 .95 .05

 150690 0 2 0.00.0672 .95 .05

 290690 0 2 0.00.0672 .95 .05

*** Record 17

 0 1 0

*** Record 18

 0 0 0.5

*** Record 19 -- STITLE

Loring Silt Loam; HYDG: C 

*** Record 20

 155 0 0 1 0 0 0 0 0 0

*** Record 26

 0 0 0

*** Record 30

 4 317

*** Record 33

 6

 1 13 1.4 0.385 0 0 0

 0.0002130.000213 0

 0.1 0.385 0.151 1.28 0

 2 23 1.4 0.37 0 0 0

 0.0002130.000213 0

 1 0.37 0.146 0.49 0

 3 33 1.4 0.37 0 0 0

 0.0002130.000213 0

 3 0.37 0.146 0.16 0

 4 30 1.45 0.34 0 0 0

 0.0002130.000213 0

 5 0.34 0.125 0.12 0

 5 23 1.49 0.335 0 0 0

 0.0002130.000213 0

 1 0.335 0.137 0.07 0

 6 33 1.51 0.343 0 0 0

 0.0002130.000213 0

 3 0.343 0.147 0.06 0

***Record 40

 0

 YEAR 10 YEAR 10 YEAR 10 1

 1

 1 -----

 7 YEAR

 PRCP TCUM 0 0

 RUNF TCUM 0 0

 INFL TCUM 1 1

 ESLS TCUM 0 0 1.0E3

 RFLX TCUM 0 0 1.0E5

 EFLX TCUM 0 0 1.0E5

 RZFX TCUM 0 0 1.0E5

 

PRZM INPUT FILE FOR SOIL ACCUMULATION ASSESSMENT 

All values are the same as above, except for the last 7 lines:

TCON TAVE 1 100

 RUNF TCUM 0 0

 INFL TCUM 1 1

 ESLS TCUM 0 0 1.0E3

 RFLX TCUM 0 0 1.0E5

 EFLX TCUM 0 0 1.0E5

RZFX TCUM 0 0 1.0E5